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[ "15143088", "19726226", "8004580", "15304029", "17940809", "15699479", "20598077" ]

[ "Low molecular weight heparin, therapy with dalteparin, and survival in advanced cancer: the fragmin advanced malignancy outcome study (FAMOUS).", "Nadroparin for the prevention of thromboembolic events in ambulatory patients with metastatic or locally advanced solid cancer receiving chemotherapy: a randomised, placebo-controlled, double-blind study.", "Subcutaneous heparin treatment increases survival in small cell lung cancer. \"Petites Cellules\" Group.", "A randomized clinical trial of combination chemotherapy with and without low-molecular-weight heparin in small cell lung cancer.", "Prophylactic anti-coagulation in cancer palliative care: a prospective randomised study.", "The effect of low molecular weight heparin on survival in patients with advanced malignancy.", "PRODIGE: a randomized placebo-controlled trial of dalteparin low-molecular-weight heparin thromboprophylaxis in patients with newly diagnosed malignant glioma." ]

[ "In experimental systems, interference with coagulation can affect tumor biology. Furthermore, it has been suggested that low molecular weight heparin therapy may prolong survival in patients with cancer. The primary aim of this study was to assess survival at 1 year of patients with advanced cancer.\n Patients with advanced malignancy (N = 385) were randomly assigned to receive either a once-daily subcutaneous injection of dalteparin (5,000 IU), a low molecular weight heparin, or placebo for 1 year.\n The Kaplan-Meier survival estimates at 1, 2, and 3 years after randomization for patients receiving dalteparin were 46%, 27%, and 21%, respectively, compared with 41%, 18%, and 12%, respectively, for patients receiving placebo (P =.19). In an analysis not specified a priori, survival was examined in a subgroup of patients (dalteparin, n = 55; and placebo, n = 47) who had a better prognosis and who were alive 17 months after randomization. In these patients, Kaplan-Meier survival estimates at 2 and 3 years from randomization were significantly improved for patients receiving dalteparin versus placebo (78% v 55% and 60% v 36%, respectively, P =.03). The rates of symptomatic venous thromboembolism were 2.4% and 3.3% for dalteparin and placebo, respectively, with bleeding rates of 4.7% and 2.7%, respectively.\n Dalteparin administration did not significantly improve 1-year survival rates in patients with advanced malignancy. However, the observed improved survival in a subgroup of patients with a better prognosis suggests a potential modifying effect of dalteparin on tumor biology.", "Clinical trials are needed to assess the clinical benefit of antithrombotic prophylaxis in patients with cancer who are receiving chemotherapy, since these patients are at an increased risk of developing a thromboembolism. We did a trial to assess the clinical benefit of the low-molecular-weight heparin nadroparin for the prophylaxis of thromboembolic events in ambulatory patients receiving chemotherapy for metastatic or locally advanced solid cancer.\n Between October, 2003, and May, 2007, ambulatory patients with lung, gastrointestinal, pancreatic, breast, ovarian, or head and neck cancer were randomly assigned in a double-blind manner to receive subcutaneous injections of nadroparin (3800 IU anti-Xa once a day, n=779) or placebo (n=387), in a 2:1 ratio. Study treatment was given for the duration of chemotherapy up to a maximum of 4 months. The primary study outcome was the composite of symptomatic venous or arterial thromboembolic events, as assessed by an independent adjudication committee. All randomised patients who received at least one dose of study treatment were included in the efficacy and safety analyses (modified intention-to-treat population). The study is registered with ClinicalTrials.gov, NCT 00951574.\n 1150 patients were included in the primary efficacy and safety analyses: 769 patients in the nadroparin group and 381 patients in the placebo group. 15 (2.0%) of 769 patients treated with nadroparin and 15 (3.9%) of 381 patients treated with placebo had a thromboembolic event (single-sided p=0.02). Five (0.7%) of 769 patients in the nadroparin group and no patients in the placebo group had a major bleeding event (two-sided p=0.18). The incidences of minor bleeding were 7.4% (57 of 769) with nadroparin and 7.9% (30 of 381) with placebo. There were 121 (15.7%) serious adverse events in the nadroparin goup and 67 (17.6%) serious adverse events in the placebo group.\n Nadroparin reduces the incidence of thromboembolic events in ambulatory patients with metastatic or locally advanced cancer who are receiving chemotherapy. Future studies should focus on patients who are at a high risk for thromboembolic events.\n Italfarmaco SpA, Milan, Italy.", "A positive influence of anticoagulant treatment in small cell lung cancer (SCLC) has been suggested by experimental and clinical data.\n In a multicenter clinical trial, 277 patients with SCLC were randomized either to receive or not to receive subcutaneous heparin injections for 5 weeks at effective doses, which were monitored by blood coagulation tests. All patients received one of the two chemotherapy regimens studied in this trial, for eight courses in the case of patients with complete or partial response, and subsequently were randomized to receive delayed thoracic radiotherapy after these eight courses.\n In comparison to the 139 patients who did not receive heparin, the 138 patients who received anticoagulant treatment obtained better complete response rates (37% vs. 23%, P = 0.004), better median survival (317 days vs. 261 days, P = 0.01), and better survival rates at 1, 2, and 3 years (40% vs. 30%, 11% vs. 9% and 9% vs. 6%, respectively). At subgroups analysis, the results on survival were obtained for limited forms (P = 0.03) but not for extensive diseases (P = 0.31). No important bleeding or thrombocytopenia was related to heparin treatment.\n These results confirm the value of anticoagulant treatment in SCLC, already suspected for warfarin and now proven for heparin, but the modes of administration and the biologic explanations for this activity still warrant further investigation.", "Small cell lung cancer (SCLC) is a chemotherapy-responsive tumor type but most patients ultimately experience disease progression. SCLC is associated with alterations in the coagulation system. The present randomized clinical trial (RCT) was designed to determine whether addition of low-molecular-weight heparin (LMWH) to combination chemotherapy (CT) would improve SCLC outcome compared with CT alone.\n Combination CT consisted of cyclophosphamide, epirubicine and vincristine (CEV) given at 3-weekly intervals for six cycles. Eighty-four patients were randomized to receive either CT alone (n = 42) or CT plus LMWH (n = 42). LMWH consisted of dalteparin given at a dose of 5000 U once daily during the 18 weeks of CT. Results Overall tumor response rates were 42.5% with CT alone and 69.2% with CT plus LMWH (P = 0.07). Median progression-free survival was 6.0 months with CT alone and 10.0 months with CT plus LMWH (P = 0.01). Median overall survival was 8.0 months with CT alone and 13.0 months with CT plus LMWH (P = 0.01). Similar improvement in survival with LMWH treatment occurred in patients with both limited and extensive disease stages. The risk of death in the CT + LMWH group relative to that in the CT group was 0.56 (95% confidence interval 0.30, 0.86) (P = 0.012 by log rank test). Toxicity from the experimental treatment was minimal and there were no treatment-related deaths.\n These results support the concept that anticoagulants, and particularly LMWH, may improve clinical outcomes in SCLC. Further clinical trials of this relatively non-toxic treatment approach are indicated.", "The objective of this study was to determine utility of prophylactic anti-coagulation in cancer patients hospitalised for palliative care in a specialised centre.\n Prospective 1:1 open randomised study was designed. Twenty patients aged 55 to 88 years with advanced cancer and an estimated life expectancy of less than 6 months were assigned to either receive treatment with 2,850/3,800 U (<70/>70 kg) of daily subcutaneous nadroparin or no treatment. Suspicion of venous thrombo-embolism (deep vein thrombosis and pulmonary embolism) was confirmed by echo-Doppler examination of the lower limbs and/or by spiral computed tomography scan of the lungs. Bleeding episodes were recorded. Platelet count was measured on days 7 and 14. Survival time from study entry was determined.\n One venous thrombo-embolism and one major bleeding occurred in the group receiving nadroparin, whereas two minor bleedings occurred in the control group. At 3 months, nine of ten participants had died in the control group vs five of ten in the group receiving nadroparin (P = 0.141). Five participants could be discharged home (P = 0.141).\n Decision to administer prophylactic nadroparin in hospitalised cancer patients under palliative care remains a challenge. Better mobility score at admission and the likelihood to be discharged home may be useful for practical purposes. The observation of a potential influence of prophylactic nadroparin on survival deserves further studies.", "Studies in cancer patients with venous thromboembolism suggested that low molecular weight heparin may prolong survival. In a double-blind study, we evaluated the effect of low molecular weight heparin on survival in patients with advanced malignancy without venous thromboembolism.\n Patients with metastasized or locally advanced solid tumors were randomly assigned to receive a 6-week course of subcutaneous nadroparin or placebo. The primary efficacy analysis was based on time from random assignment to death. The primary safety outcome was major bleeding.\n In total, 148 patients were allocated to nadroparin and 154 patients were allocated to placebo. Mean follow-up was 1 year. In the intention-to-treat analysis the overall hazard ratio of mortality was 0.75 (95% CI, 0.59 to 0.96) with a median survival of 8.0 months in the nadroparin recipients versus 6.6 months in the placebo group. After adjustment for potential confounders, the treatment effect remained statistically significant. Major bleeding occurred in five (3%) of nadroparin-treated patients and in one (1%) of the placebo recipients (P = .12). In the a priori specified subgroup of patients with a life expectancy of 6 months or more at enrollment, the hazard ratio was 0.64 (95% CI, 0.45 to 0.90) with a median survival of 15.4 and 9.4 months, respectively. For patients with a shorter life expectancy, the hazard ratio was 0.88 (95% CI, 0.62 to 1.25).\n A brief course of subcutaneous low molecular weight heparin favorably influences the survival in patients with advanced malignancy and deserves additional clinical evaluation.", "Venous thromboembolism (VTE) occurs in 20-30% of patients with malignant glioma per year of survival. We tested the efficacy of long-term dalteparin low-molecular-weight heparin (LMWH) for prevention of VTE in these patients.\n Adults with newly diagnosed malignant glioma were randomized to receive dalteparin 5000 anti-Xa units or placebo, both subcutaneously once daily for 6 months starting within 4 weeks of surgery. Treatment continued for up to 12 months. The primary outcome was the cumulative risk of VTE over 6 months. The target sample size was 512 patients. Events were adjudicated by a committee unaware of treatment.\n The trial began in 2002 and closed in May 2006 because of expiration of study medication. Ninety-nine patients were randomized to LMWH and 87 to placebo. Twenty-two patients developed VTE in the first 6 months: nine in the LMWH group and 13 in the placebo group [hazard ratio (HR) = 0.51, 95% confidence interval (CI): 0.19-1.4, P = 0.29]. At 6 months, there were three major bleeds on LMWH and none on placebo; at 12 months, 5 (5.1%) major bleeds on LMWH and 1 (1.2%) on placebo occurred (HR = 4.2, 95% CI: 0.48-36, P = 0.22). All major bleeds were intracranial and occurred while on study medication. The 12-month mortality rates were 47.8% for LMWH and 45.4% for placebo (HR = 1.2, 95% CI: 0.73-2.0, P = 0.48).\n Trends suggesting reduced VTE and increased intracranial bleeding were seen in the LMWH thromboprophylaxis group. The role of long-term anticoagulant thromboprophylaxis in patients with brain tumors remains uncertain.\n © 2010 International Society on Thrombosis and Haemostasis." ]

[ "15367427", "4607226", "9060557", "20164484", "19109560", "15987349", "9407153", "6981349", "4750180" ]

[ "The efficiency of transfusing high doses of platelets in hematologic patients with thrombocytopenia: results of a prospective, randomized, open, blinded end point (PROBE) study.", "The prophylactic treatment of thrombocytopenic leukemic patients with platelets: a double blind study.", "Randomized study of prophylactic platelet transfusion threshold during induction therapy for adult acute leukemia: 10,000/microL versus 20,000/microL.", "Dose of prophylactic platelet transfusions and prevention of hemorrhage.", "A randomized controlled trial comparing standard- and low-dose strategies for transfusion of platelets (SToP) to patients with thrombocytopenia.", "A prospective randomized trial of a prophylactic platelet transfusion trigger of 10 x 10(9) per L versus 30 x 10(9) per L in allogeneic hematopoietic progenitor cell transplant recipients.", "The threshold for prophylactic platelet transfusions in adults with acute myeloid leukemia. Gruppo Italiano Malattie Ematologiche Maligne dell'Adulto.", "Indications for platelet transfusion in children with acute leukemia.", "Prophylactic platelet transfusions in children with acute leukemia: a dose response study." ]

[ "We performed a prospective, randomized, open, blinded end point (PROBE) study to assess the efficiency of transfusing high doses of platelets in patients with thrombocytopenia, either acute leukemia (AL) or those undergoing autologous hematopoietic stem cell transplantation (AT). Patients were randomly assigned to receive transfusions with a target dose of 0.5 x 10(11)/10 kg (arm A) or 1 x 10(11)/10 kg (arm B). A total of 101 patients were included, of whom 96 were given at least one transfusion. The median time between the first transfusion and when the platelet count reached at least 20 x 10(9)/L increased from 63 hours to 95 hours in the arm B group (P = .001), and the median number of transfusions was lower in this group (2; P = .037). The total number of transfused platelets did not differ between groups (14.9 x 10(11) for arm A versus 18.5 x 10(11) for arm B; P = .156). In such patients, a prophylactic strategy of high doses of platelets could improve platelet transfusion efficiency.", "nan", "We designed and conducted a randomized single-institution trial comparing two common prophylactic platelet transfusion thresholds in patients undergoing induction therapy for acute leukemia.\n Seventy-eight patients undergoing induction therapy for acute leukemia were randomized to receive prophylactic apheresis platelet concentrates when the platelet count was either < or = 10,000/microL or < or = 20,000/microL.\n There was no significant difference in the total number of bleeding episodes per patient with a median of four in the < or = 10,000/microL arm and two in the < or = 20,000/microL arm (25th to 75th percentiles of 2, 7 and 1, 5, respectively; P = .12). Patients randomized to the < or = 10,000/microL arm received more platelet transfusions for bleeding [one (0, 2) v zero (0, 0); P = .0003]. In contrast, patients on the < or = 20,000/microL arm received more platelet transfusions for prophylactic indications [10 (5, 14) v six (3, 8); P = 0.001], as would be expected, but less for bleeding. Nevertheless, the total number of platelet transfusions given to patients on the < or = 20,000/microL arm was higher and nearly significant [11 (6, 15) v seven (5, 11); P = .07]. There were no statistically significant differences between the groups with regard to RBC transfusion requirements, febrile days, days hospitalized, days thrombocytopenic, need for HLA-matched platelets, remission rate, or death during induction chemotherapy. No patient in either group died from hemorrhage or underwent major surgery for bleeding complications.\n Giving prophylactic platelets at a threshold of < or = 10,000/microL compared with < or = 20,000/microL can decrease the total utilization of platelets with only a small adverse effect on bleeding, and no statistically significant effect on morbidity.", "We conducted a trial of prophylactic platelet transfusions to evaluate the effect of platelet dose on bleeding in patients with hypoproliferative thrombocytopenia.\n We randomly assigned hospitalized patients undergoing hematopoietic stem-cell transplantation or chemotherapy for hematologic cancers or solid tumors to receive prophylactic platelet transfusions at a low dose, a medium dose, or a high dose (1.1x10(11), 2.2x10(11), or 4.4x10(11) platelets per square meter of body-surface area, respectively), when morning platelet counts were 10,000 per cubic millimeter or lower. Clinical signs of bleeding were assessed daily. The primary end point was bleeding of grade 2 or higher (as defined on the basis of World Health Organization criteria).\n In the 1272 patients who received at least one platelet transfusion, the primary end point was observed in 71%, 69%, and 70% of the patients in the low-dose group, the medium-dose group, and the high-dose group, respectively (differences were not significant). The incidences of higher grades of bleeding, and other adverse events, were similar among the three groups. The median number of platelets transfused was significantly lower in the low-dose group (9.25x10(11)) than in the medium-dose group (11.25x10(11)) or the high-dose group (19.63x10(11)) (P=0.002 for low vs. medium, P<0.001 for high vs. low and high vs. medium), but the median number of platelet transfusions given was significantly higher in the low-dose group (five, vs. three in the medium-dose and three in the high-dose group; P<0.001 for low vs. medium and low vs. high). Bleeding occurred on 25% of the study days on which morning platelet counts were 5000 per cubic millimeter or lower, as compared with 17% of study days on which platelet counts were 6000 to 80,000 per cubic millimeter (P<0.001).\n Low doses of platelets administered as a prophylactic transfusion led to a decreased number of platelets transfused per patient but an increased number of transfusions given. At doses between 1.1x10(11) and 4.4x10(11) platelets per square meter, the number of platelets in the prophylactic transfusion had no effect on the incidence of bleeding. (ClinicalTrials.gov number, NCT00128713.)\n 2010 Massachusetts Medical Society", "A noninferiority study was performed comparing low-dose and standard-dose prophylactic platelet transfusions. A double-blind randomized controlled trial (RCT) was performed in 6 sites in 3 countries. Thrombocytopenic adults requiring prophylactic platelet transfusion were randomly allocated to standard-dose (300-600 x 10(9) platelets/product) or low-dose (150- < 300 x 10(9) platelets/product) platelets. The primary outcome (World Health Organization [WHO] bleeding > or = grade 2) was assessed daily through clinical examination, patient interview, and chart review. A WHO grade was assigned through adjudication. The Data Safety Monitoring Board stopped the study because the difference in the grade 4 bleeding reached the prespecified threshold of 5%. At this time, 129 patients had been randomized and 119 patients were included in the analysis (58 low dose; 61 standard dose). Three patients in the low-dose arm (5.2%) had grade 4 bleeds compared with none in the standard-dose arm. WHO bleeding grade 2 or higher was 49.2% (30/61) in the standard-dose arm and 51.7% (30/58) in the low-dose group (relative risk [RR], 1.052; 95% confidence interval [CI], 0.737-1.502). A higher rate of grade 4 bleeding in patients receiving low-dose prophylactic platelet transfusions resulted in this RCT being stopped. Whether this finding was due to chance or represents a real difference requires further investigation. These clinical studies are registered on (http://www.clinicaltrials.gov) as NCT00420914.", "The impact of lowering the platelet (PLT) count threshold for prophylactic PLT transfusion on bleeding and PLT use in allogeneic hematopoietic progenitor cell (HPC) transplant recipients is a matter of debate.\n In 166 patients, randomly assigned to receive prophylactic PLT transfusion at a trigger level less than 10 x 10(9) PLTs per L (T10; n = 79) or less than 30 x 10(9) per L (T30; n = 87), the number of PLT and red blood cell (RBC) transfusions given and the number of hemorrhagic events (WHO Grades 2-4) were recorded.\n No significant differences were found between the two groups regarding the clinical outcome variables (i.e., bacteremia, engraftment, graft-vs.-host disease [GVHD], hospital stay, death, and survival) or in the median total number of RBC transfusions given. The incidence, in Group T10 18 percent (14/79) and in Group T30 15 percent (13/87), as well as the type of bleeding were comparable. No deaths were attributed to hemorrhages. The number of PLT units transfused, however, was significantly lower in Group T10 (median, 4; range, 0-32), than in Group T30 (median, 10; range, 0-48; p < 0.001). Apart from the trigger level, the day of engraftment, the presence of acute GVHD, or bacteremia also affected the number of PLT transfusions.\n A prophylactic PLT transfusion trigger level of less than 10 x 10(9) PLTs per L instead of less than 30 x 10(9) PLTs per L in allogeneic HPC transplant recipients was found to be safe and resulted in a decreased use of PLTs.", "Prophylactic platelet transfusions are usually administered to patients receiving myelotoxic chemotherapy when their platelet count falls below 20,000 per cubic millimeter. Some observations suggest that lower platelet counts can be appropriate in patients in stable condition, but the safety of lower thresholds is uncertain.\n We evaluated 255 adolescents and adults (age, 16 to 70 years) with newly diagnosed acute myeloid leukemia (but not acute promyelocytic leukemia), who were treated in 21 centers. One hundred thirty-five patients were randomly assigned to receive a transfusion when their platelet count fell below 10,000 per cubic millimeter (or 10,000 to 20,000 per cubic millimeter in those with a temperature above 38 degrees C, with active bleeding, or a need for invasive procedures), and 120 patients were assigned to receive a transfusion when their platelet count was less than 20,000 per cubic millimeter.\n Patients in the group with a threshold of 10,000 platelets per cubic millimeter received 21.5 percent fewer platelet transfusions than the patients in the group with a threshold of 20,000 platelets per cubic millimeter (P=0.001). The numbers of red-cell units transfused were not significantly different between groups. Major bleeding (defined as any bleeding more than petechiae or mucosal or retinal bleeding) occurred in 21.5 and 20 percent of patients, respectively (P=0.41), and on 3.1 and 2.0 percent of the days of hospitalization. One episode of fatal cerebral hemorrhage occurred in the group with a threshold of 10,000 platelets per cubic millimeter; none occurred in the other group (P= 0.95). Actuarial estimates of survival during induction chemotherapy, actuarial estimates of the absence of major bleeding, and the length of hospital stay were not significantly different in the two groups.\n The risk of major bleeding during induction chemotherapy in adolescents and adults with acute myeloid leukemia (except acute promyelocytic leukemia, which we did not study) was similar with platelet-transfusion thresholds of 20,000 per cubic millimeter and 10,000 per cubic millimeter (or 10,000 to 20,000 per cubic millimeter when body temperature exceeded 38 degrees C, there was active bleeding, or invasive procedures were needed). Use of the lower threshold reduced platelet use by 21.5 percent.", "In an attempt ot determine the indications for platelet transfusion in thrombocytopenic patients, we randomized 56 children with acute leukemia to one of two regimens of platelet transfusion. The prophylactic group received platelets when the platelet count fell below 20,000 per mm3 irrespective of clinical events. The therapeutic group was transfused only when significant bleeding occurred and not for thrombocytopenia alone. The time to first bleeding episode was significantly longer and the number of bleeding episodes were significantly reduced in the prophylactic group. The survival curves of the two groups could not be distinguished from each other. Prior to the last month of life, the total number of days on which bleeding was present was significantly reduced by prophylactic therapy. However, in the terminal phase (last month of life), the duration of bleeding episodes was significantly longer in the prophylactic group. This may have been due to a higher incidence of immunologic refractoriness to platelet transfusion. Because of this terminal bleeding, comparison of the two groups for total number of days on which bleeding was present did not show a significant difference over the entire study period.", "nan" ]

[ "8583588" ]

[ "Urinary volume, water and recurrences in idiopathic calcium nephrolithiasis: a 5-year randomized prospective study." ]

[ "We define the role of urine volume as a stone risk factor in idiopathic calcium stone disease and test the actual preventive effectiveness of a high water intake.\n We studied 101 controls and 199 patients from the first idiopathic calcium stone episode. After a baseline study period the stone formers were divided by randomization into 2 groups (1 and 2) and they were followed prospectively for 5 years. Followup in group 1 only involved a high intake of water without any dietetic change, while followup in group 2 did not involve any treatment. Each year clinical, laboratory and radiological evaluation was obtained to determine urinary stone risk profile (including relative supersaturations of calcium oxalate, brushite and uric acid by Equil 2), recurrence rate and mean time to relapse.\n The original urine volume was lower in male and female stone formers compared to controls (men with calcium oxalate stones 1,057 +/- 238 ml./24 hours versus normal men 1,401 +/- 562 ml./24 hours, p < 0.0001 and women calcium oxalate stones 990 +/- 230 ml./24 hours versus normal women 1,239 +/- 440 ml./24 hours, p < 0.001). During followup recurrences were noted within 5 years in 12 of 99 group 1 patients and in 27 of 100 group 2 patients (p = 0.008). The average interval for recurrences was 38.7 +/- 13.2 months in group 1 and 25.1 +/- 16.4 months in group 2 (p = 0.016). The relative supersaturations for calcium oxalate, brushite and uric acid were much greater in baseline urine of the stone patients in both groups compared to controls. During followup, baseline values decreased sharply only in group 1. Finally the baseline urine in patients with recurrences was characterized by a higher calcium excretion compared to urine of the patients without recurrences in both groups.\n We conclude that urine volume is a real stone risk factor in nephrolithiasis and that a large intake of water is the initial therapy for prevention of stone recurrences. In cases of hypercalciuria it is suitable to prescribe adjuvant specific diets or drug therapy." ]

[ "17288687", "18005909", "16781588" ]

[ "Treatment of acute bronchitis with a liquid herbal drug preparation from Pelargonium sidoides (EPs 7630): a randomised, double-blind, placebo-controlled, multicentre study.", "Efficacy of a pelargonium sidoides preparation in patients with the common cold: a randomized, double blind, placebo-controlled clinical trial.", "Treatment of acute bronchitis in adults with a pelargonium sidoides preparation (EPs 7630): a randomized, double-blind, placebo-controlled trial." ]

[ "The objective of this study was to examine the efficacy and safety of a herbal drug preparation from the roots of Pelargonium sidoides (EPs 7630) in the treatment of acute bronchitis in adults outside the very restricted indication for an antibiotic therapy. Research design and methods: This was a randomised, double-blind, placebo-controlled, multicentre study with 217 patients aged between 18 and 66 years with acute bronchitis. One hundred and eight patients were given 30 drops of EPs 7630-solution three times daily and 109 patients 30 drops of placebo three times daily for a period of 7 days.\n Individual change in bronchitis symptom score (BSS) over 7 days, individual symptoms, patient satisfaction and adverse events.\n After 7 days of treatment, the BSS decreased by 7.6 +/- 2.2 points in the EPs 7630 group and by 5.3 +/- 3.2 points in the placebo group. The 95% confidence interval for the difference between the effects was calculated as 1.6-3.1, showing highly significant superiority for the EPs 7630 treatment (p < 0.0001). There were also marked improvements in the individual symptoms, which are the components of BSS - cough, chest pain on coughing, sputum, rales/rhonchi and dyspnoea - in the treatment group, relative to placebo. Patient satisfaction was very good. Only minor and transitory adverse events were recorded. No serious adverse events occurred during the trial.\n EPs 7630-solution is a well tolerated and effective treatment for acute bronchitis in adults outside the very restricted indication for an antibiotic therapy.", "The common cold is a viral infection with symptoms such as sneezing, sore throat, and running nose. It is one of the most prevalent illnesses in the world, and although commonly caused by rhinoviruses, antibiotics are often prescribed unnecessarily. Therefore, it is of utmost importance to evaluate alternative treatments such as herbal medications, whose efficacy and safety is proven by pharmacological and clinical studies.\n The aim of the present study was to evaluate the efficacy of a liquid herbal drug preparation from the roots of Pelargonium sidoides compared with placebo in adult patients with the common cold.\n The study was designed as a multicenter, prospective, randomized, double blind, parallel group, placebo-controlled phase III clinical trial with an adaptive group-sequential design.\n The study took place in eight outpatient departments affiliated with hospitals.\n One hundred three male and female adult patients with at least two major and one minor or with one major and three minor cold symptoms (maximum symptom score of 40 points), present for 24 to 48 hours, and who gave provision of informed consent were randomized to receive either 30 drops (1.5 mL) of the liquid herbal drug preparation EPs or placebo three times a day.\n Patients received randomized treatment for a maximum period of 10 days.\n The primary outcome criterion was the sum of symptom intensity differences (SSID) of the cold intensity score (CIS) from day one to day five. The CIS consists of the following 10 cold symptoms: nasal drainage, sore throat, nasal congestion, sneezing, scratchy throat, hoarseness, cough, headache, muscle aches, and fever.\n From baseline to day five, the mean SSID improved by 14.6 +/- 5.3 points in the EPs group compared with 7.6 +/- 7.5 points in the placebo group. This difference was statistically significant (P < .0001). The mean CIS decreased by 10.4 +/- 3.0 points and 5.6 +/- 4.3 points in EPs and placebo-treated patients, respectively. After 10 days, 78.8% versus 31.4% in the EPs versus placebo group were clinically cured (CIS equals zero points or complete resolution of all but a maximum of one cold symptom; P < .0001). The mean duration of inability to work was significantly lower in the EPs treatment group (6.9 +/- 1.8 days) than in the placebo group (8.2 +/- 2.1 days; P = .0003). Treatment outcome (rates of complete recovery or major improvement from disease [integrative medicine outcomes scale]) was assessed better in the EPs treatment group than in the placebo group by both the investigator and the patient on day five (P < .0001). Adverse events occurred in three of 103 patients (2.9%), with two of 52 (3.8%) and one of 51 (2.0%) patients in the EPs and placebo group, respectively. All adverse events were assessed as nonserious. At the end of treatment, all patients (100%) in the active treatment group judged the subjective tolerability of EPs as good or very good.\n EPs represents an effective treatment of the common cold. It significantly reduces the severity of symptoms and shortens the duration of the common cold compared with placebo. The herbal drug is well tolerated.", "Acute bronchitis is a widespread medical problem, and, although predominantly caused by viruses, antibiotics are still prescribed unnecessarily. Therefore, it is of utmost importance to evaluate the use of alternative treatments for acute bronchitis.\n To evaluate the efficacy and safety of a Pelargonium sidoides preparation (EPs 7630 is a registered trademark of Dr. Willmar Schwabe GmbH & Co. KG, Karlsruhe, Germany) compared with placebo in patients with acute bronchitis.\n Randomized, double-blind, placebo-controlled trial using a design with planned interim analyses.\n Six outpatient clinics.\n One hundred twenty-four adults with acute bronchitis present </=48 hours, Bronchitis Severity Score (BSS) >/=five points, and informed consent.\n EPs 7630 or placebo (30 drops three times daily) for seven days.\n The primary outcome criterion was the change of BSS on day seven.\n The decrease of BSS from baseline to day seven was 7.2 +/- 3.1 points with EPs 7630 (n = 64) and 4.9 +/- 2.7 points with placebo (n = 60). The 95% confidence interval for the difference of effects between the two treatment groups (EPs 7630 minus placebo) was calculated as (1.21, 3.56) showing a significant improvement of EPs 7630 compared with placebo on day seven (P < .0001). For each of the five individual symptoms, rates of complete recovery were considerably higher in the EPs 7630 group. Within the first four days, onset of treatment effect was recognized in 68.8% of patients in the EPs 7630 group compared with 33.3% of patients in the placebo group (P < .0001). Health-related quality of life improved more in patients treated with EPs 7630 compared with placebo-treated patients. Adverse events occurred in 25 of 124 patients (EPs 7630: 15/64 patients, placebo: 10/60 patients). All adverse events were assessed as nonserious.\n EPs 7630 was superior in efficacy compared with placebo in the treatment of adults with acute bronchitis. It may therefore offer an effective alternative for acute bronchitis unless antibiotics are clearly indicated." ]

[ "1478809", "3831339", "3886068", "7065351", "8261970", "6614773", "3058407", "378011", "1505264", "6678543", "7006427", "6493559", "3551645", "6986837", "6721407", "7048589", "1302384", "2258223", "2405730", "3675403", "7081917", "1479562", "776322", "2042093", "2197836", "1755249" ]

[ "Drainage after cholecystectomy. A prospective randomized clinical trial.", "The new ReliaVac drain after cholecystectomy. A comparative clinical and ultrasonic trial.", "Suction drainage of the gallbladder bed does not prevent complications after cholecystectomy: a random control clinical trial.", "Cholecystectomy with and without drainage. A randomized, prospective study of 300 patients.", "Cholecystectomy with and without drainage: a prospective randomised study.", "Abdominal drainage following cholecystectomy: high, low, or no suction?", "[The \"ideal\" cholecystectomy. A prospective, randomized study].", "Intraperitoneal drains and nasogastric tubes in elective cholecystectomy.", "[Routine drainage following uncomplicated, elective cholecystectomy? A prospective, randomized study].", "A prospective randomized study of drained and undrained cholecystectomies.", "Randomized trial of drainage after cholecystectomy. Suction vaersus static drainage through a main wound versus a stab incision.", "[Cholecystectomy without drainage. Randomized clinical study].", "Closed-suction versus Penrose drainage after cholecystectomy. A prospective, randomized evaluation.", "[Drainage after cholecystectomy. A controlled trial (author's transl)].", "A comparison of two types of vacuum drainage after cholecystectomy.", "A randomized study of cholecystectomy with and without drainage.", "Influence of intraperitoneal drainage after cholecystectomy; a prospective ultrasonographic study.", "Cholecystectomy with and without drainage.", "Simple elective cholecystectomy: to drain or not.", "A randomised comparison of three drainage systems following cholecystectomy.", "A randomised prospective trial of two drainage methods after cholecystectomy.", "Passive tube and suction drainage after elective cholecystectomy--a comparison using ultrasonography.", "A controlled trial of drainage after cholecystectomy.", "Cholecystectomy is safer without drainage: the results of a prospective, randomized clinical trial.", "Elective cholecystectomy without drainage and without prophylactic antibiotics. A prospective randomized trial with clinical and bacteriological aspects.", "[Elective cholecystectomy with and without subhepatic drainage. A controlled, prospective study]." ]

[ "This prospective clinical study was done to assess the efficacy of postcholecystectomy drainage. A total of 173 cholecystectomized patients were randomized into two groups; group A (86 patients) without drainage and group B (87 patients) with drainage. Group B included two types of patients; B1 (52 patients) with suction drain and B2 (35 patients) with gravity drain. Evidence of wound infection, chest complications, and duration of hospital stay were recorded in every case. Ninety five patients were assessed for chest complications and subhepatic collection by chest x-ray and abdominal ultrasonography. In group B patients the total amount of fluid drained was measured. The results were analysed by appropriate statistical methods. There was no significant difference in the rate of wound infection or atelectasis in either group, although there was apparent increase of lung complications and subhepatic collections in Group B1. The average postoperative hospital stay was significantly increased in group B patients. Considering all the parameters of this study, it was found that drainage with gravity was attended with the least morbidity.", "nan", "Some surgeons drain the gallbladder bed routinely, some selectively and some not at all. We aimed to clarify this confusion by entering 155 consecutive patients undergoing emergency and elective cholecystectomy without exploration of the common bile duct into a random control clinical trial. In 78 patients a 3 mm suction drain was left in the gallbladder bed and in 77 the abdomen was closed without drainage. There were no withdrawals, one death (in the drainage group) from myocardial infarction and one intraperitoneal abscess complicating postoperative pancreatitis (in the no-drainage group). Other events studied were postoperative pyrexia, wound infection, respiratory tract infection and duration of hospital stay. In none of these did the two groups differ either clinically or statistically. We conclude that drainage or non-drainage of the gallbladder bed must remain a matter of individual preference.", "A randomized, prospective study of 300 cholecystectomies was undertaken to evaluate the merits of drainage through a standard Penrose or Chaffin-Pratt sump tube matched against no drainage at all. There was no difference in mortality or length of hospital stay. There was, however, a significantly higher incidence of postoperative pyrexia due to atelectasis and wound infection in the drainage groups. Neither drain fulfilled its objective of providing outflow for a subhepatic collection, thus avoiding bile peritonitis. This study suggests that surgical drainage after every uncomplicated cholecystectomy is unnecessary and unwise.", "The use of subhepatic intraperitoneal drains was prospectively studied in 100 patients who underwent elective cholecystectomy for symptomatic gallstones. These patients were randomised to have subhepatic drains (group A, n = 50 patients) or to have no drains (group B, n = 50 patients). There was no difference in the age or sex composition of the two groups. The patients were followed in the post-operative period (0-7 days) for evidence of fever, wound infection, septicaemia and any evidence of intra-peritoneal bile leakage. Also post operative hospital stay of patients was noted. In group A, 14 patients (28%) developed spikes of temperature of 38 degrees C or more while only 5 patients (10%) in group B developed such episodes. The difference was statistically significant between the two groups (P < 0.05). Wound infection occurred significantly more (P < 0.05) in group A (in 15 patients) as compared to group B (in 5 patients). Septicaemia occurred in 2 patients in group A and in none in group B. There was no evidence of intraperitoneal bile leakage in either group. Patients in group A tended to have longer post operative hospital stay (mean of 10.2 days) than patients in group B (mean 8.7 days); but the difference between the two groups in this respect was not significant. We conclude that subhepatic intra-peritoneal drains offered no additional advantage in elective cholecystectomy. The evidence we had pointed to their harmful effects.", "A prospective trial to assess the effect of suction in an abdominal drain following cholecystectomy was carried out. Three types of closed drainage system were compared: a simple tube drain, a low negative pressure drain, and a high negative pressure drain: 120 consecutive patients undergoing cholecystectomy were randomly allocated to one of the three drainage groups. There was no significant difference in postoperative pyrexia, wound infection, chest infection, or hospital stay. This study failed to demonstrate any clinically useful difference between high negative pressure, low negative pressure, and static drainage system were compared: a simple tube drain, a low negative used, suction is not necessary and a simple tube drain (greater than 6 mm internal diameter) is the most effective form of drainage.", "200 patients undergoing elective cholecystectomy were studied in a prospective randomized manner. This study suggests that the nasogastric tube and postoperative iv-infusions are unnecessary. We continue to use a subhepatic drain. Exception: the senior surgeon in a straightforward case.", "nan", "A prospective randomized and controlled study of prophylactic drainage after simple, elective cholecystectomy was carried out. From March 1988 to June 1991 80 patients received an Easy-Flow drain and 80 did not. Operation and perioperative management were standardized. The endpoint of the study was postoperative morbidity, especially postoperative pyrexia and subhepatic fluid collection. The latter was identified by ultrasonography performed daily on postoperative day 1-4. No patient died. The morbidity including postoperative pyrexia revealed no difference between drained and undrained patients. In 19 of the patients with (23.8%) and in 25 of the patients without drainage (31.3%) a subhepatic fluid collection could be demonstrated by ultrasonography. This difference was not statistically significant either. We conclude that prophylactic drainage after elective, simple cholecystectomy is of no use for the patient. As subhepatic fluid collections can be seen in drained as well as in undrained patients it has to be accepted that drainage does not guarantee the removal of subhepatic fluid. Therefore its indicatory function (bleeding) and the ability to prevent the patient having biliary peritonitis or local abscess has to be put in doubt.", "One hundred twenty-three patients undergoing elective cholecystectomy at USAF Medical Center Keesler were studied in a prospective randomized manner to determine the differences in morbidity and mortality following drained and undrained cholecystectomies. The groups were compared for differences in mortality, wound infection, postoperative fever, and length of hospitalization. One death occurred due to an unrelated cause in an undrained patient. Three per cent of the undrained group developed wound infections as compared to five per cent in the drained group. This was not statistically significant. A significant difference occurred in postoperative fever between the drained (58%) and undrained (30%) groups. Postoperative hospitalization was also significantly shorter in the undrained group. This study suggests that drainage following elective cholecystectomy is not only unnecessary, but may add to postoperative morbidity and length of hospitalization.", "One hundred eighty-four patients who underwent biliary surgery were randomly allocated to four groups arranaed in a 2 by 2 design. In 92 patients the drain was brought out through the wound and in the other 92 through a stab incision. In half of the patients in each group the drain was connected to a suction system and in the other half to a sterile bag. Suction was found to impair rather than enhance intraperitoneal drainage. In patients who underwent elective cholecystectomy and early operation for acute cholecystitis, the amount of discharge was more than twice as large when suction was omitted than when it was applied. After common duct operations the amount of discharge was very large and there was little difference in cases with and without suction. Prolonged drainage, static or suction, resulted in an increase in the serum haptoglobin level. Analysis of out data suggested that after a few days the drain starts to act as a traumatic stimulus. No difference was found between cases with the drain brought out through a stab incision and those with the drain brought out through the main wound. A number of studies have ascertained the superiority of closed to open drainage. The results of the present trial lead us to recommend that after biliary surgery the closed us to recommend that after biliary surgery the closed drain should not be connected to a suction apparatus and that after elective cholecystectomy the drain should preferably be removed after a few days.", "nan", "Closed-suction drainage was compared prospectively to open, passive drainage (Penrose drains) in 128 patients undergoing cholecystectomy. Patients were randomized at the time of operation to receive either closed-suction drains (Group I, 67 patients) or Penrose drains (Group II, 61 patients). The preoperative clinical parameters of the two groups were similar. The patients in Group I when compared with those in Group II had a shorter duration of drainage (3.3 days and 4.1 days, respectively, p less than 0.01), a lesser volume of drainage in the first 48 hours postoperatively (78 ml and 132 ml, respectively, p less than 0.001), a decreased incidence of fever on the night of operation (24 of 67 patients and 39 of 61 patients, respectively, p less than 0.05) and on the first postoperative day (26 of 67 patients and 32 of 61 patients, respectively, p less than 0.05), and a lower leukocyte count on the first postoperative day (12,000 cells/mm3 and 14,100 cells/mm3, respectively, 0.05 less than p less than 0.1). Patients in Group I tended to have a lower rate of wound infection (1 of 67 patients versus 5 of 61 patients in Group II, 0.05 less than p less than 0.1) and had a much lower incidence of drain site tenderness (8 of 67 patients in Group I versus 24 of 61 patients in Group II, p less than 0.05). This study demonstrates the superiority of closed-suction drains over open, passive drains after cholecystectomy.", "nan", "Following cholecystectomy, 50 patients were randomly allocated for suction drainage by small (2.5 mm) Redivac or large calibre (6 mm) Redivac drains. There were 25 patients in each group. Subhepatic collection was detected by ultrasonic examination in 5 patients on the seventh postoperative day. The smaller drain was used in all of these patients. Of these 5 patients, one developed pulmonary infection, a second had internal bleeding requiring laparotomy, while the remaining 3 were asymptomatic. Subhepatic fluid was not detected in any patient who had the larger drain.", "Routine drainage of the bed of the gallbladder following cholecystectomy remains controversial. A prospectively randomized series of 100 instances of cholecystectomy for chronic and subsiding acute cholecystitis are reviewed. Postoperative fever was lowered, the need for dressing changes was virtually eliminated and hospital stay was shortened in patients who did not undergo drainage. No complications attributable to drain avoidance were seen.", "One hundred and fifty patients were prospectively randomised into 3 groups (50 in each group); to receive a passive drain, closed suction drain or no drain after elective cholecystectomy. The drain was removed within 24 hours in 84% of patients and was continued longer only if the amount of drainage was excessive or bilious. On the 3rd post-operative day, an ultrasound examination was performed in all patients for detection of subhepatic/subphrenic collection. Collections were more frequently encountered in the patients without any drain (42%) followed by passive drain (26%) and suction drain group (20%). Chest complications were frequently noted (passive drain; 6% suction drain, 12%, and no drain, 8%), however, occurrence of this complication in various groups was similar (p > 0.1). Two patients (4%) without drain required ultrasound guided aspiration of subhepatic collection. Mean post-operative hospital stay was nearly equal for all the groups (passive drain: 4.22 +/- 1 days, suction drain: 4.26 +/- 1.4 days and no drain: 4.62 +/- 2.3 days). Drainage reduced the incidence of post-cholecystectomy collections and need for invasive intervention for collection related complications. However, the type of drainage (active or passive) did not influence the incidence of collection, frequency of complications and duration of post-operative hospital stay.", "nan", "We performed a large single-center prospective randomized controlled study to assess the role of peritoneal drainage in simple elective cholecystectomy. In 248 patients, drains were omitted; 122 patients had closed suction drains and 124 had Penrose drains. There were no deaths, and no patient required reoperation or drainage of a subhepatic collection. Wound infections occurred in eight patients with drains and in six patients without. Most infections were staphylococcal. Postoperative pulmonary complications and hospital stays were similar in patients with and without drains. Statistical analysis of the 10 available prospective controlled randomized studies (1,920 patients) by the method of odds ratios supported our findings. Simple elective cholecystectomy is safe without peritoneal drainage, but short-term drains do not increase morbidity.", "The efficacy of low pressure, high pressure and passive drainage systems have been compared after cholecystectomy. Symptoms of pain, discomfort and nausea were compared using linear analogue scales and spirometry was used to examine pre-operative and postoperative respiratory function. The low pressure suction drain removed an intraperitoneal marker, gentamicin, more effectively than the high pressure suction drain, but not more effectively than the passive drain. There were no differences in postoperative respiratory function nor in the amount of pain or discomfort between the groups. The passive drain group reported less nausea than the suction drain groups. If a negative pressure drainage system is to be used, a low pressure suction drain should be used in preference to a high pressure system.", "A prospective trial is described in which simple tube drainage was compared with suction drainage after cholecystectomy. Postoperative chest infection and infected or painful drain wounds were both significantly more common with simple tube drains. Postoperative discomfort was more frequent with tube drains in situ and wound infection more common in the suction group, but neither of these differences was statistically significant. The mean volume of fluid drained and duration of hospital stay did not differ between methods. It is concluded that both methods are satisfactory, but suction drainage is recommended.", "Daily ultrasonography of the gallbladder bed was performed in patients with suction or passive tube drains after elective cholecystectomy. A total of 19 patients was randomized to suction drainage and 17 to passive tube drainage. A policy of early drain removal was followed. No significant difference was found between the volume drained and the size of collection detected in either group. Significant bile leaks were detected and were adequately drained by suction and passive tube drains. There were no complications from drains. In view of these findings, we advocate short-term drainage of the gallbladder bed after both open and laparoscopic cholecystectomy using the drain of the surgeon's choice.", "A prospective controlled trial of drainage after cholecystectomy has been carried out. In a consecutive series of 143 patients undergoing cholecystectomy, 50 patients were randomly allocated to a drainage group and a further 50 patients to a non-drainage group. The remaining 43 patients were drained electively because the common bile duct was explored or because of infection or incomplete haemostasis. There was no significant difference in the incidence of wound infection or other complications between the drainage and the non-drainage groups. The duration of postoperative pyrexia, the number of analgesic injections and the length of postoperative hospital stay were the same in both the randomized groups. One patient in the randomized drainage group had a reactionary haemorrhage from the drain site requiring transfusion. There was no mortality but one patient in the elective drainage group had to be re-explored for a subhepatic abscess. Three patients in this group drained bile from the drain for 3-9 days but all had a T tube in place. This trial fails to demonstrate any advantage or disadvantage in draining the gallbladder bed after cholecystectomy.", "Drainage after cholecystectomy remains routine despite the lack of scientific supportive data. Numerous clinical studies in the past have attempted to address this controversy but have failed to resolve the issue for different reasons. These include retrospective design, inclusion of only selected cases, and randomization before surgery. In this study 479 patients undergoing cholecystectomy were randomly allocated to a drainage group (a high-pressure suction drain in Morison's pouch for 48 hours) or a nondrainage group. Randomization was performed at the time of peritoneal closure. All patients undergoing cholecystectomy, both elective and urgent, were included and the operations were performed by all grades of surgeons. There were two deaths from cardiopulmonary causes, both in the drainage group. No patient required reoperation in either group. The incidence of both wound infections (15 vs 5; p less than 0.05) and chest infections (56 vs 19, p less than 0.02) was significantly higher in the drainage group. Three hundred fifty-six patients underwent abdominal ultrasonography 72 hours after surgery. The number of subhepatic fluid collections thus detected was significantly higher in the patients who received a drain (17 vs 6, p less than 0.05). None of these collections was clinically significant. The postoperative hospital stay was longer in the patients with drains (10.3 vs 9.1 days), but this difference failed to reach statistical significance. We conclude from this study that the use of a drain after cholecystectomy serves no useful purpose and is potentially harmful. This practice should be abandoned.", "A consecutive series of 50 patients undergoing elective cholecystectomy without prophylactic antibiotics entered a prospective randomized trial to compare the post-operative clinical course whether the subhepatic space was drained or not. 26 patients (mean age 58 yrs) were drained and 24 patients (mean age 59 yrs) were not. The incidence of positive gallbladder bile cultures were respectively 8 and 19% (N.S.) in the drained and undrained groups. The incidence of post-operative mortality, thrombo-phlebitis and intra-abdominal sepsis was zero in both groups. In the drained or undrained series, the incidence of wound infection was respectively 4% and 0% (N.S.), that of urinary infection was 8% and 13% (N.S.) and that of pulmonary atelectasis was 15 and 17% (N.S.). A further consecutive series of 100 undrained elective cholecystectomies (18% positive bile cultures) without prophylactic antibiotics was then performed with the same uneventful postoperative course. This study therefore indicates that even in the presence of bacterobilia elective cholecystectomy can be safely performed without subhepatic space drainage and without prophylactic antibiotics.", "Based on the data of 56 patients undergoing elective cholecystectomy the value of subhepatic drainage is evaluated in a randomized controlled clinical trial. The design of the study and the perioperative management of the patients are described in detail and the results analyzed according to clinical course, blood tests and abdominal ultrasound." ]

[ "7214791", "6587296", "7149292" ]

[ "Fenoprofen and codeine analgesia.", "Comparative efficacy of fenoprofen calcium and zomepirac sodium in postsurgical dental pain.", "A double-blind comparison of parenteral morphine, placebo, and oral fenoprofen in management of postoperative pain." ]

[ "Studies were conducted on postpartum and postoperative patients to estimate the dose-response line of fenoprofen and to contrast it with codeine and placebo. The postpartum patients included women with episiotomy pain and with uterine cramping. This mix allowed contrast of ability of the various pain models to distinguish codeine from placebo. The methodology for the studies was single-dose parallel groups design with interviews conducted by trained nurse observers to obtain subjective responses. More than 850 patients participated in the trial. The results indicate that fenoprofen at doses as low as 12.5 mg has analgesic properties. In each of the five studies, the mean value of 100- and/or 200-mg doses of fenoprofen for the variable sum of the pain intensity difference (SPID) was higher than that of 65 mg codeine. The pooled relative potency calculation based on SPID suggests that 100 mg fenoprofen is approximately equivalent to 60 mg codeine. In their ability to distinguish codeine from placebo, patients with uterine cramp, episiotomy, or surgical pain did not appear to differ.", "The relative analgesic efficacy of zomepirac sodium 100 mg and fenoprofen calcium 200 mg was evaluated in patients with pain due to surgical removal of dental impactions. This is the first study to make a direct comparison of their effectiveness. This study is especially important since zomepirac sodium was recently removed from the market as an analgesic for acute pain. Zomepirac sodium was extremely popular among clinicians and was considered the most effective of the peripherally acting analgesics. Patients were requested to take a single dose of study medication when they had moderate to severe pain. The study medications were identical in appearance and randomly allocated under double-blind conditions. The medication was evaluated over the next 4 hours according to subjective analgesic measurement scales. The primary measures of efficacy included total pain relief ( TOTPAR ), sum pain intensity difference ( SPID ), overall evaluation, and time to remedication . Of the 136 patients entered, 117 were included in the efficacy analysis. Both active agents demonstrated marked superiority to placebo (p less than 0.001) for all efficacy measures but were inseparable from each other. The mean analgesic efficacy values for both zomepirac sodium and fenoprofen calcium were almost identical. The nineteen subjects who reported side effects were evenly distributed among the three groups. No serious side effects occurred. The results of this study indicate that fenoprofen calcium 200 mg and zomepirac sodium 100 mg are equally efficacious, with similar onset, peak, and total analgesic effects.", "A double-blind study comparing parenteral morphine, 8 mg, with parenteral placebo and with oral fenoprofen, 200 mg, for the relief of postoperative pain following outpatient surgery was undertaken in 90 patients. The study drugs were administered within 2 hours of the operation and the Visual Analogue Scale was used to assess pain intensity. Patients given placebos showed minimal change in mean pain intensity, whereas patients who received morphine had significantly less pain at all assessment periods. Pain relief in patients who received fenoprofen was, for the first 2 hours, better than following placebo but not as good as following morphine, but thereafter, there was no significant difference between the morphine and fenoprofen and both were significantly better than placebo. It is concluded that oral analgesics may be a useful alternative to the traditional parenteral analgesics for outpatient surgery." ]

[ "15880077", "16847014", "19937983", "17941782", "11477354", "15794797" ]

[ "Laparoscopic versus open living-donor nephrectomy: experiences from a prospective, randomized, single-center study focusing on donor safety.", "Comparison of laparoscopic and mini incision open donor nephrectomy: single blind, randomised controlled clinical trial.", "Randomized clinical trial of laparoscopic versus open donor nephrectomy.", "Laparoscopic v open donor nephrectomy for pediatric kidney recipients: preliminary report of a randomized controlled trial.", "Randomized controlled trial of hand-assisted laparoscopic versus open surgical live donor nephrectomy.", "Comparison of laparoscopic and open donor nephrectomy: a randomized controlled trial." ]

[ "Very few randomized studies on laparoscopic (L) versus open (O) living-donor nephrectomy (LDN) have been presented. The largest randomized series reported so far included 80 donors. In 2000, an Australian safety group concluded that the evidence base for L-LDN is inadequate to make recommendations regarding safety and efficacy.\n With this background, at our single national center, 122 donors were randomized to left-sided L-LDN (n=63) or O-LDN (n=59), from February 2001 to May 2004. This article summarizes our experiences, in particular regarding complications and safety.\n There were significant differences in favor of O-LDN regarding operative time, warm ischemia time, and vessel lengths, whereas the analgesic requirements and pain data were significantly in favor of the laparoscopic procedure. In the L-LDN group, there were five major postoperative complications resulting in reoperations (8%), including two intestinal perforations. No major complications occurred in the O-LDN group.\n These results from our randomized study do suggest that conventional O-LDN is a very secure procedure, superior to L-LDN regarding donor safety. There has been an unacceptably high rate of reoperations in our L-LDN series but without mortality or significant sequelae. A careful look at some other L-LDN series also suggests increased morbidity/mortality. Our data do, however, support the view that a perfect, uncomplicated L-LDN appears to be the superior procedure, and the laparoscopic procedure is still evolving. Donor safety may be improved by avoiding obese donors, stapling of the renal artery (not clipping), and perhaps by hand assistance. Furthermore, we will consider the retroperitoneal approach.", "To determine the best approach for live donor nephrectomy to minimise discomfort to the donor and to provide good graft function.\n Single blind, randomised controlled trial.\n Two university medical centres, the Netherlands.\n 100 living kidney donors.\n Participants were randomly assigned to either laparoscopic donor nephrectomy or to mini incision muscle splitting open donor nephrectomy.\n The primary outcome was physical fatigue using the multidimensional fatigue inventory 20 (MFI-20). Secondary outcomes were physical function using the SF-36, hospital stay after surgery, pain, operating times, recipient graft function, and graft survival.\n Conversions did not occur. Compared with mini incision open donor nephrectomy, laparoscopic donor nephrectomy resulted in longer skin to skin time (median 221 v 164 minutes, P < 0.001), longer warm ischaemia time (6 v 3 minutes, P < 0.001), less blood loss (100 v 240 ml, P < 0.001), and a similar number of complications (intraoperatively 12% v 6%, P = 0.49, postoperatively both 6%). After laparoscopic nephrectomy, donors required less morphine (16 v 25 mg, P = 0.005) and shorter hospital stay (3 v 4 days, P = 0.003). During one year's follow-up mean physical fatigue was less (difference - 1.3, 95% confidence interval - 2.4 to - 0.1) and physical function was better (difference 6.2, 2.0 to 10.3) after laparoscopic nephrectomy. Function of the graft and graft survival rate of the recipient at one year censored for death did not differ (100% after laparoscopic nephrectomy and 98% after open nephrectomy).\n Laparoscopic donor nephrectomy results in a better quality of life compared with mini incision open donor nephrectomy but equal safety and graft function.", "This randomized controlled trial was designed to determine the safety and efficacy of laparoscopic donor nephrectomy (LDN) in comparison with short-incision open donor nephrectomy (ODN).\n Eighty-four live kidney donors were randomized in a 2 : 1 ratio to LDN (56 patients) or short-incision ODN without rib resection (28). Primary endpoints were pain relief and duration of inpatient stay.\n There was no donor death or allograft thrombosis in either group. The first warm ischaemic time median (range) 4 (2-7) versus 2 (1-5) min; P = 0.001) and the duration of operation (160 (110-250) versus 150 (90-200); P = 0.004) were longer for LDN. LDN led to a reduction in parenteral morphine requirement 59 (6-136) versus 90 (35-312) mg; P = 0.001) and hospital stay (4 (2-6) versus 6 (2-9) days; P = 0.001), and earlier return to employment (42 (14-84) versus 66.5 (14-112) days; P = 0.004). Postoperative respiratory function was improved after LDN. There were more postoperative complications per donor in the ODN group (0.6(0.7) versus 0.3(0.5); P = 0.033). At a median follow-up of 74 months, there were no differences in renal function or allograft survival between the groups.\n LDN removes some of the disincentives to live donation without compromising the outcome of the recipient transplant.\n Copyright 2009 British Journal of Surgery Society Ltd. Published by John Wiley & Sons, Ltd.", "Laparoscopic surgery is widely accepted for nephrectomy in adult renal transplantation. The success of this technique has not been compared with open donor nephrectomy (ODN) in children.\n In this randomized clinical trial, 40 adult kidney donors were randomly divided into two groups: 20 cases of laparoscopic donor nephrectomy (LDN) and 20 of ODN. Recipients had an age of <15 years. Our exclusion criteria were previous renal transplantation, hemolytic uremic syndrome, focal segmental glomerulosclerosis, oxalosis in the recipients, and multiple renal arteries bilaterally in donors.\n All donor nephrectomies were completed as scheduled, and no patients undergoing LDN required conversion to open nephrectomy. No patients in either the ODN or the LDN group required reoperation. Acute rejection was diagnosed in six patients receiving kidneys procured by ODN (30%) and 4 patients (20%) receiving kidneys obtained by LDN (P = 0.3). No recipients or donors died. At 1 year, the graft survival times in the ODN and LDN groups were 310.8 +/- 28.8 and 302.7 +/- 28.2 days, respectively (P = 0.8).\n At our medical center, pediatric LDN recipients had graft outcomes similar to those of ODN recipients. We recommend LDN for harvest of kidneys for pediatric recipients at experienced centers.", "Laparoscopic live donor nephrectomy for renal transplantation is being performed in increasing numbers with the goals of broadening organ supply while minimizing pain and duration of convalescence for donors. Relative advantages in terms of recovery provided by laparoscopy over standard open surgery have not been rigorously assessed. We hypothesized that laparoscopic as compared with open surgical live donor nephrectomy provides briefer, less intense, and more complete convalescence.\n Of 105 volunteer, adult, potential living-renal donors interested in the laparoscopic approach, 70 were randomly assigned to undergo either hand-assisted laparoscopic or open surgical live donor nephrectomy at a single referral center. Objective data and subjective recovery information obtained with telephone interviews and validated questionnaires administered 2 weeks, 6 weeks, and 6-12 months postoperatively were compared between the 23 laparoscopic and 27 open surgical patients.\n There was 47% less analgesic use (P=0.004), 35% shorter hospital stay (P=0.0001), 33% more rapid return to nonstrenuous activity (P=0.006), 23% sooner return to work (P=0.037), and 73% less pain 6 weeks postoperatively (P=0.004) in the laparoscopy group. Laparoscopic patients experienced complete recovery sooner (P=0.032) and had fewer long-term residual effects (P=0.0015).\n Laparoscopic donor nephrectomy is associated with a briefer, less intense, and more complete convalescence compared with the open surgical approach.", "Authors from Iran compare various outcomes between laparoscopic and open donor nephrectomy in kidney transplantation; they carried out a large comparative trial, and found that laparoscopic donor nephrectomy gave better donor satisfaction and morbidity, with equivalent graft outcome.\n To compare the graft survival, donor and recipient outcome, donor satisfaction, and complications of laparoscopic (LDN) and open donor nephrectomy (ODN) in kidney transplantation.\n In a randomized controlled trial, 100 cases each of LDN and ODN were compared. We modified the standard LDN procedure to make it less expensive.\n The mean (sd) operative duration was 152.2 (33.9) min for ODN and 270.8 (58.5) min for LDN, and the mean duration of kidney warm ischaemia was 1.87 min for ODN and 8.7 min for LDN. Only one LDN required conversion to ODN because of bleeding. The mean follow-up in the LDN and ODN groups was not significantly different (406.1 vs 403.8 days). The mean (sd) score for donor satisfaction was 17.3 (3.5) for ODN and 19.6 (1.0) for LDN. The rate of ureteric complications was 2% for ODN and none for LDN. As determined by serum creatinine levels at 3, 21-30, 90, 180 and 365 days after surgery, graft function was not significantly different between ODN and LDN. Long-term graft survival was 93.8% for LDN and 92.7% for ODN.\n Compared to ODN, LDN was associated with greater donor satisfaction, less morbidity and equivalent graft outcome." ]

[ "18984887", "16203961" ]

[ "Extended vs short-term buprenorphine-naloxone for treatment of opioid-addicted youth: a randomized trial.", "Comparison of pharmacological treatments for opioid-dependent adolescents: a randomized controlled trial." ]

[ "The usual treatment for opioid-addicted youth is detoxification and counseling. Extended medication-assisted therapy may be more helpful.\n To evaluate the efficacy of continuing buprenorphine-naloxone for 12 weeks vs detoxification for opioid-addicted youth.\n Clinical trial at 6 community programs from July 2003 to December 2006 including 152 patients aged 15 to 21 years who were randomized to 12 weeks of buprenorphine-naloxone or a 14-day taper (detox).\n Patients in the 12-week buprenorphine-naloxone group were prescribed up to 24 mg per day for 9 weeks and then tapered to week 12; patients in the detox group were prescribed up to 14 mg per day and then tapered to day 14. All were offered weekly individual and group counseling.\n Opioid-positive urine test result at weeks 4, 8, and 12.\n The number of patients younger than 18 years was too small to analyze separately, but overall, patients in the detox group had higher proportions of opioid-positive urine test results at weeks 4 and 8 but not at week 12 (chi(2)(2) = 4.93, P = .09). At week 4, 59 detox patients had positive results (61%; 95% confidence interval [CI] = 47%-75%) vs 58 12-week buprenorphine-naloxone patients (26%; 95% CI = 14%-38%). At week 8, 53 detox patients had positive results (54%; 95% CI = 38%-70%) vs 52 12-week buprenorphine-naloxone patients (23%; 95% CI = 11%-35%). At week 12, 53 detox patients had positive results (51%; 95% CI = 35%-67%) vs 49 12-week buprenorphine-naloxone patients (43%; 95% CI = 29%-57%). By week 12, 16 of 78 detox patients (20.5%) remained in treatment vs 52 of 74 12-week buprenorphine-naloxone patients (70%; chi(2)(1) = 32.90, P < .001). During weeks 1 through 12, patients in the 12-week buprenorphine-naloxone group reported less opioid use (chi(2)(1) = 18.45, P < .001), less injecting (chi(2)(1) = 6.00, P = .01), and less nonstudy addiction treatment (chi(2)(1) = 25.82, P < .001). High levels of opioid use occurred in both groups at follow-up. Four of 83 patients who tested negative for hepatitis C at baseline were positive for hepatitis C at week 12.\n Continuing treatment with buprenorphine-naloxone improved outcome compared with short-term detoxification. Further research is necessary to assess the efficacy and safety of longer-term treatment with buprenorphine for young individuals with opioid dependence.\n clinicaltrials.gov Identifier: NCT00078130.", "The prevalence of heroin and other opioid use has markedly increased among adolescents in the last decade; however, virtually no research has been conducted to identify effective treatments for this population.\n To evaluate the relative efficacy of 2 pharmacotherapies, the partial opioid agonist buprenorphine hydrochloride and the centrally active alpha(2)-adrenergic blocker clonidine hydrochloride, in the detoxification of opioid-dependent adolescents.\n A double-blind, double-dummy, parallel-groups randomized controlled trial conducted in a university-based research clinic from October 2001 to December 2003. Patients were a volunteer sample of 36 adolescents who met DSM-IV criteria for opioid dependence (ages 13-18 years eligible).\n Participants were randomly assigned to a 28-day, outpatient, medication-assisted withdrawal treatment with either buprenorphine or clonidine. Both medications were provided along with thrice weekly behavioral counseling and incentives contingent on opiate abstinence. Postdetoxification, all participants were offered the opportunity for continued treatment with the opiate antagonist, naltrexone hydrochloride.\n Treatment retention, opiate abstinence, and human immunodeficiency virus risk behavior, along with measures of withdrawal and medication effects.\n A significantly greater percentage of adolescents who received buprenorphine were retained in treatment (72%) relative to those who received clonidine (39%) (P<.05). For those in the buprenorphine group, a significantly higher percentage of scheduled urine test results were opiate negative (64% vs 32%; P = .01). Participants in both groups reported relief of withdrawal symptoms and drug-related human immunodeficiency virus risk behavior. Those in the buprenorphine condition generally reported more positive effects of the medication. No evidence of opioid intoxication or psychomotor impairment was observed. Sixty-one percent of participants in the buprenorphine condition and 5% of those in the clonidine group initiated treatment with naltrexone.\n Combining buprenorphine with behavioral interventions is significantly more efficacious in the treatment of opioid-dependent adolescents relative to combining clonidine and behavioral interventions." ]

[ "8057111", "3076200", "3288477" ]

[ "The Sydney Multicentre Study of Parkinson's disease: a randomised, prospective five year study comparing low dose bromocriptine with low dose levodopa-carbidopa.", "Long term bromocriptine treatment in de novo parkinsonian patients.", "A double-blind study of bromocriptine and L-dopa in de novo Parkinson's disease. Short-term results." ]

[ "149 previously untreated patients with Parkinson's disease were recruited over a three year period and randomly allocated to either low dose levodopa-carbidopa (< or = 600/150 mg/day) or low dose bromocriptine (< or = 30 mg/day). A five year follow up is reported on the 126 patients who completed the dose titration and who have not developed features of atypical Parkinsonism. Levodopa-carbidopa in low dosage adequately controlled symptoms in most patients and delayed the appearance of dyskinesia and end of dose failure for about two years longer than conventional doses. Only a few patients could be managed for more than one year on low dose bromocriptine alone; these patients had mild disease and asymmetric signs. Patients randomised to bromocriptine did not develop dyskinesia or troublesome end of dose failure until levodopa-carbidopa was added. The prevalence of dyskinesia in this group was lower than in patients given levodopa-carbidopa alone. The prevalence of end of dose failure was similar in the two randomisation groups once levodopa was introduced.", "nan", "The first phase of a longitudinal multicenter study comparing bromocriptine and L-dopa (as Sinemet) as de novo therapy for Parkinson's disease using a double-blind randomized design has recently been completed. Over a period of 5.5 months, bromocriptine and L-dopa were equipotent in reducing functional and neurological disability. These observations complement and extend earlier studies and suggest a role for bromocriptine as de novo therapy of Parkinson's disease." ]

[ "11368133", "10426608", "12521468", "15491755" ]

[ "Anxiety levels in women attending colposcopy clinics for treatment for cervical intraepithelial neoplasia: a randomised trial of written and video information.", "Is the provision of information leaflets before colposcopy beneficial? A prospective randomised study.", "Can pre-colposcopy sessions reduce anxiety at the time of colposcopy? A prospective randomised study.", "Could precolposcopy information and counseling reduce women's anxiety and improve knowledge and compliance to follow-up?" ]

[ "To assess the effectiveness of video information in reducing the level of anxiety in women attending Colposcopy clinics.\n An observational study followed by a randomised trial.\n Colposcopy Clinic, Royal Free Hospital, London.\n Between April and December 1999, all new referrals to the clinic with a cervical smear showing moderate or severe dyskaryosis.\n The level of anxiety measured by the Spielberger State Anxiety Inventory.\n Women attending colposcopy clinics for either diagnosis or treatment, experience a high level of anxiety. The highest levels occur in women attending a one-stop see and treat clinic. The introduction of visual information in the form of an explanatory video prior to attendance significantly reduced anxiety.", "To assess the usefulness of a leaflet distributed to women before colposcopy designed to reduce their anxiety and psychosexual morbidity by providing information.\n Prospective randomised study.\n Colposcopy clinic of a large district general hospital.\n Two hundred consecutive women undergoing colposcopy for the first time for a cervical cytological abnormality of severity no greater than moderate dyskaryosis.\n Women were randomised into one of two groups (leaflet or control). Those in the leaflet group were sent an information leaflet prior to attending the clinic. In the colposcopy clinic all the women completed a State/Trait Anxiety Inventory (StAI/TrAI) and a modified psychosexual questionnaire before undergoing colposcopy. This was repeated at the six-month follow up visit. Women in the leaflet group also completed a further questionnaire on the leaflet.\n Differences of anxiety and psychosexual scores between leaflet and control groups.\n The leaflet was well received. There were no statistical differences in StAI and TrAI scores between the study group and the control group at either visit, although in the whole study population StAI and TrAI scores were reduced at the second visit. The leaflet group had significantly more psychosexual problems but by the second visit, the scores had improved and the two groups were similar. When the mean differences in anxiety and psychosexual scores at the initial and second visits were compared between the groups, the reduction in negative sexual feelings and deterioration of TrAI scores experienced by the leaflet group was significant.\n This study suggests that the provision of sending an information leaflet prior to colposcopy is not beneficial in isolation. Other approaches need to be considered.", "The main objective of this prospective randomised study was to evaluate whether offering pre-colposcopy group sessions reduces anxiety at the time of colposcopy. We also examined whether this strategy improved knowledge about abnormal smears and colposcopy and improved satisfaction with the colposcopy service provided. One hundred and forty-seven women undergoing colposcopy for the first time were randomised into two groups. The control group (n = 75) received conventional management. The study group (n = 72), in addition to conventional management, were invited to attend a pre-colposcopy group session led by a trained colposcopy nurse. Questionnaires were used to determine state anxiety inventory scores and knowledge scores at the time of randomisation, immediately before colposcopy and 6 weeks after the clinic visit. Satisfaction questionnaires were completed 6 weeks after the clinic visit. We found that women attending colposcopy clinics are anxious. Those women who attended the pre-colposcopy session had improved knowledge scores (P = 0.039) at the time of colposcopy and satisfaction (P = 0.037). However, the intervention failed to significantly reduce anxiety at the time of colposcopy (P > 0.05).", "To investigate the effects of precolposcopy counseling on women's anxiety, knowledge about colposcopy and compliance to follow-up.\n Two hundred and twenty women referred for colposcopy for the first time were recruited. They attended precolposcopy sessions in which written and video information were given and subsequently were randomized to have either further explanation and discussion with an experienced colposcopic nurse (study group) or no further discussion (control group). Each subject completed a Chinese version of the state-anxiety questionnaire (STAI) and a knowledge questionnaire before and immediately after the precolposcopy sessions and also before the colposcopy examination. Women's concern and opinion on the programme were also assessed. Follow-up data was compared with those who did not attend the precolposcopy sessions.\n Women's knowledge about colposcopy significantly improved after the precolposcopy sessions. The improvement was more significant in the study group than in the control group immediately after the sessions (P = 0.003). The difference between the groups in knowledge scores remained statistically significant before colposcopic examination (P = 0.015) but the difference diminished between these two assessment points. There was no statistically significant difference between the two groups in the anxiety scores at all assessment points. Women who attended the precolposcopy sessions had a significantly higher attendance rates and better compliance to follow-up than those who did not attend the sessions.\n Precolposcopy session with explanation and discussion improves women's knowledge about colposcopy, but has negligible effects on women's anxiety before colposcopy. Provision of written and video information at the precolposcopy sessions can improve compliance to follow-up after colposcopy." ]

[ "11783226", "16965740" ]

[ "[Clinical study on treatment of mid-late stage gastric carcinoma by composite xiansu capsule combined with chemotherapy].", "[Immunoregulation and short-term therapeutic effects of super-selective intra-arterial chemotherapy combined with traditional Chinese drugs on gastric cancer patients]." ]

[ "To assess the effect and mechanism of composite Xiansu Capsule (CXSC) combined with chemotherapy in treating gastric carcinoma of mid-late stage.\n The 61 patients of the test group were treated by CXSC combined with chemotherapy and 30 patients of the control group treated with chemotherapy alone. The effect of treatment and cell mediated immunity of patients were observed.\n The effective rate of the test group and the control group was 32.8% and 13.3% respectively (P < 0.05), the chemotherapy caused toxic reaction occurrence was less in the former than that in the latter group (P < 0.01). The CD3 level of patients in the test group was decreased, and CD4/CD8 level was raised obviously, which suggested that CXSC had immuno-regulating effect on T-cells.\n CXSC could enhance the efficacy and reduce the toxic side-effect of chemotherapy. To regulate the cell mediated immunity of patients is possibly its mechanism.", "To investigate the immunoregulation and short-term therapeutic effects of super-selective intra-arterial chemotherapy combined with Fuzheng Kang'ai Granules, a compound Chinese herbal medicine, on patients with late gastric cancer.\n Forty patients with late gastric antrum cancer were randomly divided into study group and control group. Patients in the study group were orally administered Fuzheng Kang'ai Granules 48 hours after the first super-selective left gastric artery chemotherapy with high-dose drugs (EAP regime: VP(16) 100 mg/m(2) + epirubicin 60 mg/m(2) + carboplatin 200 mg/m(2)), while patients in the control group were only administered the same local artery chemotherapy as in the study group.\n The short-term therapeutic efficacy in the study group and control group were 82.5% and 57.5% respectively (P<0.01). The occurrence rates of side effects in the study group were significantly lower than those in the control group (P<0.01). The Karnofsky score of life quality of the study group was obviously higher than that of the control group after treatment (P<0.05). The half survival time and one year survival rate in the study group and control group were (24.9 +/- 1.36) month, 70% (28/40) and (13.7 +/- 0.72) month, 35% (14/40) respectively. They were significantly improved in the study group compared with the control group (P<0.01). The levels of cytokines interleukin 2 (IL-2), tumor necrosis factor-alpha (TNF-alpha), interferon-gamma (IFN-gamma) after treatment in the study group were significantly higher than those before treatment (P<0.05 or P<0.01), as well as than those after treatment in the control group (P<0.01). On the other hand, the level of immune inhibitory factor soluble interleukin-2 receptor (sIL-2R) after treatment in the study group was lower than that before treatment, as well as than that after treatment in the control group (P<0.01).\n The super-selective intra-arterial chemotherapy combined with Fuzheng Kang'ai Granules has good short-term therapeutic efficiency and few side effects for patients with late gastric antrum cancer. It can significantly improve the life quality, extend the survival period, and improve the survival rate in patients with late gastric antrum cancer, which may be due to the up-regulation of the immune regulating factors such as IL-2, TNF-alpha, IFN-gamma and down-regulation of the immune inhibitory factor sIL-2R." ]

[ "11009140", "15494910", "17404000" ]

[ "Doxycycline and rifampicin for mild scrub-typhus infections in northern Thailand: a randomised trial.", "A comparative trial of a single dose of azithromycin versus doxycycline for the treatment of mild scrub typhus.", "Controlled trial of a 5-day course of telithromycin versus doxycycline for treatment of mild to moderate scrub typhus." ]

[ "Some strains of scrub typhus in northern Thailand are poorly responsive to standard antirickettsial drugs. We therefore did a masked, randomised trial to compare rifampicin with standard doxycycline therapy for patients with scrub typhus.\n Adult patients with strictly defined, mild scrub typhus were initially randomly assigned 1 week of daily oral treatment with 200 mg doxycycline (n=40), 600 mg rifampicin (n=38), or doxycycline with rifampicin (n=11). During the first year of treatment, the combined regimen was withdrawn because of lack of efficacy and the regimen was replaced with 900 mg rifampicin (n=37). Treatment outcome was assessed by fever clearance time (the time for oral temperature to fall below 37.3 degrees C).\n About 12,800 fever patients were screened during the 3-year study to recruit 126 patients with confirmed scrub typhus and no other infection, of whom 86 completed therapy. Eight individuals received the combined regimen that was discontinued after 1 year. The median duration of pyrexia was significantly shorter (p=0.01) in the 24 patients treated with 900 mg daily rifampicin (fever clearance time 22.5 h) and in the 26 patients who received 600 mg rifampicin (fever clearance time 27.5 h) than in the 28 patients given doxycycline monotherapy (fever clearance time 52 h). Fever resolved in a significantly higher proportion of patients within 48 h of starting rifampicin (900 mg=79% [19 of 24], 600 mg=77% [20 of 26]) than in patients treated with doxycycline (46% [13 of 28]; p=0.02). Severe gastrointestinal events warranted exclusion of two patients on doxycyline. There were two relapses after doxycycline therapy, but none after rifampicin therapy.\n Rifampicin is more effective than doxycycline against scrub-typhus infections acquired in northern Thailand, where strains with reduced susceptibility to antibiotics can occur.", "Scrub typhus is one of the most important endemic infections in the Asia-Pacific region. Although tetracyclines or chloramphenicol are the recommended drugs of choice for the treatment of scrub typhus, reports of doxycycline-resistant strains have prompted a search for alternative treatments.\n We conducted a prospective, open-label, randomized trial from September 2002 through November 2003 to compare azithromycin with doxycycline for the treatment of mild scrub typhus. The time to defervescence was assessed to compare the efficacy of the 2 treatment regimens.\n A total of 93 patients were randomly assigned to receive either a single 500-mg dose of azithromycin or a 1-week course of daily oral 200-mg dose of doxycycline. Cure was achieved in 47 (100%) of 47 patients in the azithromycin-treated group and in 43 (93.5%) of 46 patients in the doxycycline-treated group (P=.117). The median time to defervescence was 21 h for the azithromycin-treated group and 29 h for the doxycycline-treated group (P=.097). There were no serious adverse events during the study. No relapses occurred in either group during a 1-month follow-up period.\n The single 500-mg dose of azithromycin was as effective as the 1-week course of daily 200-mg doses of doxycycline for the treatment of mild scrub typhus acquired in South Korea.", "New antibiotics are required to have the antibacterial activity against doxycycline-resistant Orientia tsutsugamushi. An in vitro sensitivity study showed that telithromycin was more effective than erythromycin for Rickettsia, Bartonella, and Coxiella burnetii. In this prospective, open-label, randomized trial, we enrolled patients with mild-to-moderate scrub typhus. We compared the efficacy and safety of a 5-day telithromycin therapy with those of a 5-day doxycycline therapy at Chosun University Hospital or one of its two community-based affiliated hospitals (Jangheung Hospital and Cheomdan Hospital), which are all located in southwestern Korea, between September and December 2005. A total of 92 patients were randomly assigned to either the telithromycin group (n = 47) or the doxycycline group (n = 45). After the treatment, fever control time was 20.45 +/- 12.9 h in the telithromycin group and 22.60 +/- 21.44 h in the doxycycline group (P > 0.05). After the treatment, the cure rate was 100% in the telithromycin group and 97.8% in the doxycycline group (P > 0.05). Furthermore, there were no significant differences in time elapsed until such symptoms as headache, myalgia, and rash disappeared. No serious adverse events or death were noted following the treatment in both groups. There were no significant differences in adverse events. In conclusion, the efficacy and safety of a 5-day once-a-day regimen of 800 mg telithromycin were equivalent to those of a 5-day twice-a-day regimen of 100 mg doxycycline in patients with mild-to-moderate scrub typhus. Telithromycin could be considered a promising new antibacterial agent for patients with scrub typhus." ]

[ "1417466", "3517228", "3525523", "10579658", "2652180", "8431099" ]

[ "The treatment of agitation during initial hospitalization after traumatic brain injury.", "Propranolol treatment of assaultive patients with organic brain disease. A double-blind crossover, placebo-controlled study.", "Therapeutic effects of pindolol on behavioral disturbances associated with organic brain disease: a double-blind study.", "Cognitive and behavioural efficacy of amantadine in acute traumatic brain injury: an initial double-blind placebo-controlled study.", "Treatment of behavioral problems with pindolol.", "Effect of methylphenidate on brain injury-related anger." ]

[ "Agitation after traumatic brain injury is disruptive for patient care, distressing, and difficult to treat. The use of propranolol has been advocated to control agitation after brain injury. It reportedly lacks some of the deleterious cognitive and emotional effects of other medications and physical restraints. This study was designed to test if propranolol is effective in reducing agitated behavior. Subjects had traumatic closed-head injury treated at a combined Level I Trauma Center and Rehabilitation Center. Twenty-one subjects met the criteria of agitation and were treated with propranolol or placebo in a double-blind fashion. The intensity of agitation was significantly lower in the treatment group although the number of episodes were similar. The use of restraints was also significantly lower in the treatment group. The results support the effectiveness of propranolol in reducing the intensity of agitation during the initial hospitalization after closed-head injury.", "A double-blind, placebo-controlled crossover study was conducted to examine the effects of long-acting propranolol in the treatment of violent behavior associated with organic brain disease in 10 patients whose symptoms had proved refractory to various conventional medications. Long-acting propranolol treatment was associated with reductions of assaultive behavior without apparent sedative effects. Cautions are noted regarding potential undesirable side effects which may necessitate careful patient monitoring during treatment.", "A double-blind, placebo-controlled crossover study was conducted to examine the effects of pindolol for the treatment of 11 patients with impulsive, explosive behaviors and other emotional-behavioral abnormalities as a consequence of brain disease or injury. Pindolol treatment was associated with significant therapeutic benefits without sedation and without the use-limiting side effects that occur with propranolol.", "The objective of the current study was to determine the efficacy of amantadine in improving cognitive and behavioural performance in a traumatic brain injury (TBI) rehabilitation sample. The design was a prospective, randomized, double-blind, placebo-controlled, crossover design. Subjects were 10 adult traumatic brain injury patients in an acute brain injury rehabilitation unit. Subjects received a 2-week trail of amantadine or placebo, followed by a 2-week washout, then a 2-week trail of the alternative (placebo or amantadine). Neuropsychological outcome measures included orientation, attention, executive function, memory, orientation, behaviour, and a composite variable. Results of repeated measures ANOVA and regression analysis of slope/change showed a main effect of time, but no significant difference for amantadine versus placebo. In conclusion, although patients generally improved, this initial exploratory study found no differences in rate of cognitive improvement between subjects given amantadine versus those given placebo. However, the small sample size, heterogeneous population, acute time course, and large number of dependent variables limit power and generalizability. Implications are discussed for further research to better answer questions regarding efficacy of amantadine post-TBI.", "A study was conducted on a group of chronically hospitalized, brain-damaged male patients to assess the effectiveness of treatment with pindolol on behavioral problems. The study was conducted in two parts. The first was a double-blind, placebo-controlled analysis of the effect of pindolol on assaultive behavior, both verbal and physical. The second part was open and sought to determine whether pindolol would diminish such behaviors as resistance to care, sexual preoccupation, or provocation of others, which were sufficient to preclude placement at a lower level of care. These target behaviors and nursing interventions were monitored and clinical global assessments of improvement in behavior and of suitability for lower levels of care were developed. Eight of 13 patients were considered improved. Those with significant premorbid personality disorders showed little benefit. Pindolol appears to ameliorate some management problems and, by inference, improve the quality of life in many patients with behavioral pathology due to organic brain disease.", "Anger and temper outbursts can be serious clinical problems after brain injury. This study used a randomized, pretest, posttest, placebo control group, single-blind design to evaluate the therapeutic usefulness of methylphenidate to control brain-injury-related anger. The 38 subjects in the study were young adult males who had sustained serious brain injuries and who were beyond the period of rapid, spontaneous recovery. The subjects were divided into two groups, one that received 30 mg of methylphenidate per day and the placebo control group. A comparison of the drug group with the placebo group before and at the end of the six-week treatment period on all the anger outcome measures analyzed simultaneously with multivariate analysis indicated a significant drug-by-time interaction effect, F(4.33) = 5.29, p = .002, demonstrating the therapeutic effect of methylphenidate on anger. The study found that drug responders could be predicted by pretreatment level of anger with a .09 probability of misclassification. Methylphenidate also significantly reduced impairment on all of the general psychopathology outcome measures (F[3.31] = 5.42, p < .01). The drug improved memory for those subjects in the treatment response group but did not result in changes on measures of attention, nor did it have an effect on a checklist of subjective side effects, suggesting that it has minimal or absent cognitive toxicity and is likely to be tolerated well by individuals with brain injuries." ]

[ "16141449", "12365879", "18005494", "16648318", "18055931", "16836598", "15458988", "12873325", "15259827", "11479066", "16055807", "18626299" ]

[ "A randomised multicentre trial of integrated versus standard treatment for patients with a first episode of psychotic illness.", "Randomized controlled trial of interventions designed to reduce the risk of progression to first-episode psychosis in a clinical sample with subthreshold symptoms.", "Acute-phase and 1-year follow-up results of a randomized controlled trial of CBT versus Befriending for first-episode psychosis: the ACE project.", "Randomized, double-blind trial of olanzapine versus placebo in patients prodromally symptomatic for psychosis.", "The Lambeth Early Onset Crisis Assessment Team Study: general practitioner education and access to an early detection team in first-episode psychosis.", "Randomized controlled trial of a cannabis-focused intervention for young people with first-episode psychosis.", "Cognitive therapy for the prevention of psychosis in people at ultra-high risk: randomised controlled trial.", "Suicide prevention in first episode psychosis: the development of a randomised controlled trial of cognitive therapy for acutely suicidal patients with early psychosis.", "A randomized controlled trial of a brief intervention for families of patients with a first episode of psychosis.", "Early intervention and a five year follow up in young adults with a short duration of untreated psychosis: ethical implications.", "Interventions in the initial prodromal states of psychosis in Germany: concept and recruitment.", "A preliminary trial of adherence-coping-education (ACE) therapy for early psychosis." ]

[ "To evaluate the effects of integrated treatment for patients with a first episode of psychotic illness.\n Randomised clinical trial.\n Copenhagen Hospital Corporation and Psychiatric Hospital Aarhus, Denmark.\n 547 patients with first episode of schizophrenia spectrum disorder.\n Integrated treatment and standard treatment. The integrated treatment lasted for two years and consisted of assertive community treatment with programmes for family involvement and social skills training. Standard treatment offered contact with a community mental health centre.\n Psychotic and negative symptoms (each scored from 0 to a maximum of 5) at one and two years' follow-up.\n At one year's follow-up, psychotic symptoms changed favourably to a mean of 1.09 (standard deviation 1.27) with an estimated mean difference between groups of -0.31 (95% confidence interval -0.55 to -0.07, P = 0.02) in favour of integrated treatment. Negative symptoms changed favourably with an estimated difference between groups of -0.36 (-0.54 to -0.17, P < 0.001) in favour of integrated treatment. At two years' follow-up the estimated mean difference between groups in psychotic symptoms was -0.32 (-0.58 to -0.06, P = 0.02) and in negative symptoms was -0.45 (-0.67 to -0.22, P < 0.001), both in favour of integrated treatment. Patients who received integrated treatment had significantly less comorbid substance misuse, better adherence to treatment, and more satisfaction with treatment.\n Integrated treatment improved clinical outcome and adherence to treatment. The improvement in clinical outcome was consistent at one year and two year follow-ups.", "Most disability produced by psychotic illnesses, especially schizophrenia, develops during the prepsychotic period, creating a case for intervention during this period. However, only recently has it been possible to engage people in treatment during this phase.\n A randomized controlled trial compared 2 interventions in 59 patients at incipient risk of progression to first-episode psychosis. We termed this group ultra-high risk to emphasize the enhanced risk vs conventional genetic high-risk studies. Needs-based intervention was compared with specific preventive intervention comprising low-dose risperidone therapy (mean dosage, 1.3 mg/d) and cognitive behavior therapy. Treatment was provided for 6 months, after which all patients were offered ongoing needs-based intervention. Assessments were performed at baseline, 6 months, and 12 months.\n By the end of treatment, 10 of 28 people who received needs-based intervention progressed to first-episode psychosis vs 3 of 31 from the specific preventive intervention group (P=.03). After 6-month follow-up, another 3 people in the specific preventive intervention group became psychotic, and with intention-to-treat analysis, the difference was no longer significant (P=.24). However, for risperidone therapy-adherent patients in the specific preventive intervention group, protection against progression extended for 6 months after cessation of risperidone use.\n More specific pharmacotherapy and psychotherapy reduces the risk of early transition to psychosis in young people at ultra-high risk, although their relative contributions could not be determined. This represents at least delay in onset (prevalence reduction), and possibly some reduction in incidence.", "The ACE project involved 62 participants with a first episode of psychosis randomly assigned to either a cognitive behaviour therapy (CBT) intervention known as Active Cognitive Therapy for Early Psychosis (ACE) or a control condition known as Befriending. The study hypotheses were that: (1) treating participants with ACE in the acute phase would lead to faster reductions in positive and negative symptoms and more rapid improvement in functioning than Befriending; (2) these improvements in symptoms and functioning would be sustained at a 1-year follow-up; and (3) ACE would lead to fewer hospitalizations than Befriending as assessed at the 1-year follow-up.\n Two therapists treated the participants across both conditions. Participants could not receive any more than 20 sessions within 14 weeks. Participants were assessed by independent raters on four primary outcome measures of symptoms and functioning: at pretreatment, the middle of treatment, the end of treatment and at 1-year follow-up. An independent pair of raters assessed treatment integrity.\n Both groups improved significantly over time. ACE significantly outperformed Befriending by improving functioning at mid-treatment, but it did not improve positive or negative symptoms. Past the mid-treatment assessment, Befriending caught up with the ACE group and there were no significant differences in any outcome measure and in hospital admissions at follow-up.\n There is some preliminary evidence that ACE promotes better early recovery in functioning and this finding needs to be replicated in other independent research centres with larger samples.", "This study assessed the efficacy of olanzapine in delaying or preventing conversion to psychosis and reducing symptoms in people with prodromal symptoms of schizophrenia.\n This randomized trial occurred at four North American clinics in the Prevention Through Risk Identification, Management, and Education project. Outpatients received olanzapine (5-15 mg/day, N=31) or placebo (N=29) during a 1-year double-blind treatment period and no treatment during a 1-year follow-up period. Efficacy measures included the conversion-to-psychosis rate and Scale of Prodromal Symptoms scores.\n During the treatment year, 16.1% of olanzapine patients and 37.9% of placebo patients experienced a conversion to psychosis, a nearly significant difference. The hazard of conversion among placebo patients was about 2.5 times that among olanzapine-treated patients, which also approached significance. In the follow-up year, the conversion rate did not differ significantly between groups. During treatment, the mean score for prodromal positive symptoms improved more in the olanzapine group than in the placebo group, and the mixed-model repeated-measures least-squares mean score showed significantly greater improvement between weeks 8 and 28 with olanzapine. The olanzapine patients gained significantly more weight (mean=8.79 kg, SD=9.05, versus mean=0.30 kg, SD=4.24).\n A significant treatment difference in the conversion-to-psychosis rate was not demonstrated. However, these results may be influenced by low power. The nearly significant differences suggest that olanzapine might reduce the conversion rate and delay onset of psychosis. Olanzapine was efficacious for positive prodromal symptoms but induced weight gain. Further treatment research in this phase of illness is warranted.", "There are few evaluations of strategies to improve rates of early detection and treatment of patients with first-episode psychosis.\n To evaluate the effectiveness of a general practitioner (GP) education programme and an early detection assessment team (the Lambeth Early Onset Crisis Assessment Team; LEO CAT) in reducing delays in accessing treatment for first-episode psychosis patients.\n 46 clusters of GP practices randomised to GP education in early detection with direct access to LEO CAT v. care as usual. Primary outcome measures were GP referral rates, duration of untreated psychosis (DUP) and delays in receiving treatment.\n 150 patients with first-episode psychosis were recruited; 113 were registered with the study GPs, who referred 54 (47.7%) directly to mental health services. Significantly more intervention group GPs (86.1% v. 65.7%) referred their patients directly to mental health services and fewer patients experienced long delays in receiving treatment. However, their overall DUP was unaffected.\n Educating GPs improves detection and referral rates of first-episode psychosis patients. An early detection team reduces the long delays in initial assessment and treatment. However, these only impact on the later phases of the DUP. Broader measures, such as public health education, are needed to reduce the earlier delays in DUP.", "To evaluate a cannabis-focused intervention (cannabis and psychosis therapy: CAP) for patients continuing to use cannabis following initial treatment for first-episode psychosis (FEP).\n Consecutive admissions to an early psychosis program were screened and consenting individuals using cannabis in the 4 weeks prior to assessment participated. A single-blind randomized controlled trial compared CAP (n = 23) with a clinical control condition (psychoeducation, PE; n = 24). There were no significant differences between the CAP and PE groups on cannabis use at end of treatment and 6 months post-intervention.\n There were no significant group differences on psychopathology and functional ratings at follow-up. A significant reduction in cannabis use was observed for both groups over time.\n PE and specific cannabis-focused intervention are associated with similar reductions in cannabis use in an FEP cohort. Simple interventions may therefore be worth considering prior to intensive psychotherapeutic efforts with this population.", "Advances in the ability to identify people at high risk of developing psychosis have generated interest in the possibility of preventing psychosis.\n To evaluate the efficacy of cognitive therapy for the prevention of transition to psychosis.\n A randomised controlled trial compared cognitive therapy with treatment as usual in 58 patients at ultra-high risk of developing a first episode of psychosis. Therapy was provided over 6 months, and all patients were monitored on a monthly basis for 12 months.\n Logistic regression demonstrated that cognitive therapy significantly reduced the likelihood of making progression to psychosis as defined on the Positive and Negative Syndrome Scale over 12 months. In addition, it significantly reduced the likelihood of being prescribed antipsychotic medication and of meeting criteria for a DSM-IV diagnosis of a psychotic disorder. Analysis of covariance showed that the intervention also significantly improved positive symptoms of psychosis in this population over the 12-month period\n Cognitive therapy appears to be an acceptable and efficacious intervention for people at high risk of developing psychosis.", "Young people with early psychosis are at particularly high risk of suicide. However, there is evidence that early intervention can reduce this risk. Despite these advances, first episode psychosis patients attending these new services still remain at risk. To address this concern, a program called LifeSPAN was established within the Early Psychosis Prevention and Intervention Centre (EPPIC). The program developed and evaluated a number of suicide prevention strategies within EPPIC and included a cognitively oriented therapy (LifeSPAN therapy) for acutely suicidal patients with psychosis. We describe the development of these interventions in this paper.\n Clinical audit and surveys provided an indication of the prevalence of suicidality among first episode psychosis patients attending EPPIC. Second, staff focus groups and surveys identified gaps in service provision for suicidal young people attending the service. Third, a suicide risk monitoring system was introduced to identify those at highest risk. Finally, patients so identified were referred to and offered LifeSPAN therapy whose effectiveness was evaluated in a randomised controlled trial.\n Fifty-six suicidal patients with first episode psychosis were randomly assigned to standard clinical care or standard care plus LifeSPAN therapy. Forty-two patients completed the intervention. Clinical ratings and measures of suicidality and risk were assessed before, immediately after the intervention, and 6 months later. Benefits were noted in the treatment group on indirect measures of suicidality, e.g., hopelessness. The treatment group showed a greater average improvement (though not significant) on a measure of suicide ideation.\n Early intervention in psychosis for young people reduces the risk of suicide. Augmenting early intervention with a suicide preventative therapy may further reduce this risk.", "Carers' satisfaction with psychiatric services related to information and advice is generally poor. This may be particularly true for services trying to meet the needs of ethnically diverse communities. It is important that services attempt to ameliorate carers' concerns as early as possible. The authors aimed to assess the impact of a brief educational and advice support service on carers of patients with a first episode of psychotic illness.\n Carers of all patients identified with a first episode of psychosis in a defined psychiatric catchment area of North London were invited to participate. Following consent from patients and relatives, relatives were randomly allocated to receive (in addition to usual services) a brief intervention comprising education and advice about the disorder from a support team or to usual care from community psychiatric services.\n One hundred and six carers were recruited to the study. Take-up of the intervention was less than expected and the intervention had little impact. The authors found no differences over time between the randomized arms for relatives' satisfaction (F = 23, p = 0 .4, df = 1) or number of days spent by patients in hospital over nine months from entry to the trial (F= 1.7, p= 0.18, df = 1).\n It was found that the support and advice intervention for families had little impact on their satisfaction or on patients' outcomes. However, failure to take up the intervention threatens the conclusions as the power to show an effect was reduced. Although family interventions, in general, are considered an important adjunct to the treatment of patients with chronic psychosis, there may be difficulties in providing an educational and support intervention shortly after first onset. How and when psychiatric services provide information and advice to carers of people newly diagnosed with a psychosis requires further study.", "In a Dutch treatment intervention study of patients (n=76) with first psychotic episodes of schizophrenia the hypothesis tested was whether early differential treatment after an acute psychotic break improved outcome as compared with other studies. Patients had a relatively short duration of untreated psychosis. No significant effect between two treatment conditions on relapse rate was found. The 15-month intervention program kept the psychotic relapse rate as low as 15%; lower than comparable studies. Thus, the initial results were in support of the hypothesis. After completion of the 15 months study, patients were referred to other agencies and followed for five years. Results of the follow up study showed that the low relapse rate could not be maintained. Of the remaining 71 patients of the initial sample, 52% had one or more psychotic relapses, 25% developed chronic positive symptoms and 23% did not have another psychotic episode. In addition, the level of social functioning turned out to be low: the majority of patients were dependent upon their parents, few held down a skilled or paid job and also their quality of life seemed low, results indicate that early intervention may improve short term but not long term outcome in schizophrenia. Our results also suggest that referral to other mental health agencies after intervention is not sufficient. Continuity of outpatient care, including continuity of a professional relationship, continuity of support for the family, and the continuity in management of illness, medication and stress may be a key issue in the first five years after the onset of psychosis in schizophrenia. Early recognition and intervention may not nearly be as important for outcome as continuity in care and caregivers. At present, however, it remains questionable whether early intervention programs in first-episode patients with a short duration of untreated psychosis can offer the prospect of altering the course of schizophrenia without a sustained comprehensive treatment program.", "The Early Detection and Intervention Programme of the German Research Network on Schizophrenia (GRNS) investigates the initial prodromal phase of psychosis in a multidimensional approach. Two intervention strategies are being studied by two large-scale multicentre projects.\n To present the concept of the intervention studies, and to provide an interim report of the recruitment procedure.\n Comprehensive cognitive-behavioural therapy has been developed for patients in the \"early initial prodromal state\". For patients in the \"late initial prodromal state\" the atypical neuroleptic amisulpride is explored. Both interventions are evaluated in randomised controlled trials using clinical management as the control condition.\n Between January 2001 and March 2003, 1212 individuals seeking help for mental health problems were screened for putative prodromal symptoms at four university centres. More than 388 individuals fulfilled criteria for both interventions and 188 (48.5%) gave informed consent to participate in the trials.\n The screening procedure appears to be feasible and trial participation seems to be acceptable to a relevant proportion of people at increased risk of developing psychosis.", "A pilot randomized controlled trial was conducted to examine the effectiveness of adherence-coping-education (ACE) therapy. Twenty-four individuals with early psychosis were randomized to receive 14 sessions of either ACE therapy in addition to treatment as usual, or supportive therapy in addition to treatment as usual. Participants were assessed at baseline, midtreatment, and posttreatment on measures of medication attitudes, psychotic and depressive symptoms, and social functioning. ACE therapy was well tolerated and was associated with significant decrease in symptoms, as well as trend-level improvements in attitudes toward treatment. These results lend initial support for the feasibility of ACE Therapy, and suggest that it may have promise in facilitating recovery for individuals recovering from an initial psychotic episode." ]

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[ "Effects of two types of brief intervention and readiness to change on alcohol use in hazardous drinkers.", "Randomised controlled trial of general practitioner intervention in patients with excessive alcohol consumption.", "Screening and referral for brief intervention of alcohol-misusing patients in an emergency department: a pragmatic randomised controlled trial.", "A randomized study of secondary prevention of early stage problem drinkers in primary health care.", "[Multicenter study on the efficacy of advice for the prevention of alcoholism in primary health care].", "Brief intervention in a primary care setting for hazardous drinkers.", "Brief physician advice for alcohol problems in older adults: a randomized community-based trial.", "Brief physician advice for problem alcohol drinkers. A randomized controlled trial in community-based primary care practices.", "Brief intervention in alcohol-positive traffic casualties: is it worth the effort?", "Evaluation of a controlled drinking minimal intervention for problem drinkers in general practice (the DRAMS scheme).", "Effectiveness of brief intervention on non-dependent alcohol drinkers (EBIAL): a Spanish multi-centre study.", "Intervention in alcohol abuse among macrocytic patients in general practice.", "Reducing alcohol consumption. Comparing three brief methods in family practice.", "Effectiveness of nurse-led brief alcohol intervention: a cluster randomized controlled trial.", "Women and alcohol abuse in primary care. Identification and intervention.", "[Effectiveness of brief medical counseling to reduce drinkers' alcohol consumption].", "Evaluating the effects of a brief motivational intervention for injured drinkers in the emergency department.", "Cost-effectiveness analysis of a brief intervention delivered to problem drinkers presenting at an inner-city hospital emergency department.", "The efficacy of a brief alcohol intervention combined with %CDT feedback in patients being treated for type 2 diabetes and/or hypertension.", "Controlled evaluation of a general practice-based brief intervention for excessive drinking.", "Brief intervention for female heavy drinkers in routine general practice: a 3-year randomized, controlled study.", "Excessive drinking--brief intervention by a primary health care nurse. A randomized controlled trial.", "Randomized controlled trial of general practitioner intervention in women with excessive alcohol consumption.", "Screening for problem drinking and counseling by the primary care physician-nurse team.", "Brief physician- and nurse practitioner-delivered counseling for high-risk drinkers: does it work?", "Alcohol interventions in a trauma center as a means of reducing the risk of injury recurrence.", "A randomized trial of a brief primary-care-based intervention for reducing at-risk drinking practices." ]

[ "Brief interventions for hazardous and low-dependent drinkers in the primary care setting have considerable empirical support. The purpose of this study was to (1) evaluate the effects of brief advice (BA) and motivational enhancement (ME) interventions on alcohol consumption. In addition, a hindsight matching design was used to (2) study the moderator effects of patient readiness to change (alcohol use) on alcohol consumption.\n The subjects (N = 301, 70% men) were patients 21 years of age or older who presented for treatment at one of 12 primary care clinics. After screening for eligibility and providing consent to participate in the study, the patients completed a baseline assessment and were randomly assigned to the BA, ME or standard care (SC) interventions condition. Follow-up assessments were completed at 1-, 3-, 6-, 9- and 12-months postbaseline assessment.\n Evaluation of the first hypothesis (n = 232 for these analyses) showed that all participants tended to reduce their alcohol use considerably between the baseline and 12-month assessments. In addition, evaluation of the second hypothesis showed a moderator effect of readiness to change in predicting the number of drinks at 12 months, such that the BA intervention seemed more effective for patients relatively low in readiness to change compared to those higher in readiness. Readiness to change did not seem to be related to changes in drinking of participants in the SC or ME conditions.\n The results confirm that, among primary care patients, substantial changes in alcohol consumption are possible. They further suggest that matching studies of patient readiness to change their alcohol use, as well as other variables, are warranted.", "To determine effectiveness of advice from general practitioners to heavy drinkers to reduce their excessive alcohol consumption (35 U or more a week for men, 21 U or more for women).\n Randomised, controlled double blind trial over 12 months with interim assessment at six months.\n Group practices (n = 47; list size averaging 10,000) recruited from Medical Research Council's general practice research framework, mostly in rural or small urban settings.\n Patients recruited after questionnaire survey. Of total of 2571 (61.2%) of 4203 patients invited for interview who attended, 909 (35.4%) stated that in past seven days they had drunk above the limits set for study and had not received advice; they were randomised to control and treatment groups.\n Patients in treatment group were interviewed by general practitioner (who had had a training session) and received advice and information about how to reduce consumption and also given a drinking diary.\n Study aimed at detecting a reduction in proportion of men with excessive alcohol consumption of 30% in treatment group and 20% in control group (for women 40% and 20%, respectively) with a power of 90% at 5% level of significance. In addition, corroborative measures such as estimation of gamma-glutamyltransferase activity were included.\n At one year a mean reduction in consumption of alcohol of 18.2 (SE 1.5) U/week had occurred in treated men compared with a reduction of 8.1 (1.6) U/week in controls (p less than 0.001). The proportion of men with excessive consumption at interview had dropped by 43.7% in the treatment group compared with 25.5% in controls (p less than 0.001). A mean reduction in weekly consumption of 11.5 (1.6) U occurred in treated women compared with 6.3 (2.0) U in controls (p less than 0.05), with proportionate reductions of excessive drinkers in treatment and control groups of 47.7% and 29.2% respectively. Reduction in consumption increased significantly with number of general practitioner interventions. At one year the mean value for gamma-glutamyltransferase activity had dropped significantly more in treated men (-2.4 (0.9)IU/l) than in controls (+1.1(1.0)IU/l; t = 2.7, p less than 0.01). Reduction in gamma-glutamyltransferase activity tended to increase with number of intervention sessions in men. Changes in gamma-glutamyltransferase activity in women and changes in other indicators in both sexes did not differ significantly between treatment and control groups.\n If the results of this study were applied to the United Kingdom intervention by general practitioners could each year reduce to moderate levels the alcohol consumption of some 250000 men and 67500 women who currently drink to excess. General practitioners and other members of the primary health care team should therefore be encouraged to include counselling about alcohol consumption in their preventive activities.", "Alcohol misuse is highly prevalent among people attending emergency departments, but the effect of intervention by staff working in these departments is unclear. We investigated the effect of screening and referral of patients found to be misusing alcohol while attending an emergency department.\n We undertook a single-blind pragmatic randomised controlled trial. Patients received either an information leaflet or an information leaflet plus an appointment with an alcohol health worker. Outcome data were collected by patient interview and examination of hospital records at 6 and 12 months.\n 599 patients were randomised over a 12-month period. At 6 months, those referred to an alcohol health worker were consuming a mean of 59.7 units of alcohol per week compared with 83.1 units in the control group (t -2.4, p=0.02). At 12 months those referred were drinking 57.2 units per week compared with 70.8 in controls (t -1.7, p=0.09). Those referred to the alcohol health worker had a mean of 0.5 fewer visits to the emergency department over the following 12 months (1.2 compared with 1.7, t -2.0, p=0.046). Differences in quality of life were not found.\n Opportunistic identification and referral for alcohol misuse in an emergency department is feasible, associated with lower levels of alcohol consumption over the following 6 months, and reduces reattendance at the department. Short-term reductions in alcohol consumption associated with referral for brief intervention for alcohol misuse benefit patients and reduce demand for accident and emergency department services.", "The subjects were recruited from participants in a health examination of random samples of the adult population in Stockholm county. Those aged 18-64 years who admitted a high alcohol consumption (greater than 40 g 100% ethanol/day) among men and greater than 30 g among women) or had an elevated value of serum-gammaglutamyltransferase (GGT) (cut-off point 1.0 microkatal/l for men and 0.6 microkatal/l for women) or had certain other indications of a high alcohol consumption were included. More severe cases, and those with an elevated GGT due to reasons other than alcohol, were excluded. The remaining subjects, 70 men and 13 women, were allocated at random to either an intervention or a comparison group. An elevated GGT was the main inclusion criteria. The subjects in the comparison group were advised by the general practitioner to cut their alcohol consumption, while those in the intervention group made further visits to their general practitioner, who gave general support and used an elevated GGT as an indication of the recent level of alcohol consumption at consecutive visits. There were three visits on average, so we are comparing a group receiving advice with a group receiving further minimal intervention. At the one-year follow-up there were greater, however not significant, reduction in GGT-level, in self-reported alcohol consumption and in a 'problem index' in the minimal intervention group than in the comparison group.", "The aim of this study was to analyse and to verify the efficacy of systematic advice for alcoholism prevention, assessing the reduction of the number in risk drinkers.\n A multicenter randomized controlled clinical trial was designed, to perform in general practitioner setting, on a sample of risk drinkers (alcohol intake > 280 g weekly, without dependence) sent by random in intervention group (systematic brief advice with support material and a five visit program during a year) and control group (once brief advice and a control in 1 year). The procedure to incorporate in both groups included physical exam, a blood test and the MALT questionnaire. A descriptive and analytic study on included variables was realised, assessing the percentage of drinkers who reduced alcohol intake below risk limit at the end of a year follow up, as well as the reduction intake in each group.\n Of the 139 included males, 75 were in the intervention group and 64 in the control group. The percentage of patients not excluded by MALT > 10, and/or liver disease, that finished the 1 year follow up, was 46%, being the sample average age of 43 +/- 11.8. Patients included in both groups were initially comparable. At the end of a year follow up there were statistically significant differences in: percentage of risk drinkers who decreased alcohol intake below 280 g weekly (82% intervention group; 47% control group); percentage of reduction in GPT, GGT, triglycerides, systolic blood pressure and the MALT questionnaire.\n The efficacy of isolated advice of general practitioner was proved to achieve the alcohol intake reduction below the risk limit accepted in male risk drinkers without alcohol dependence. The systematic follow up during a year significantly improves the results achieved with the isolated advice.", "The study was designed to test a brief intervention for reducing alcohol consumption among moderate to heavy (hazardous) drinkers in a busy HMO primary care setting.\n In a randomized controlled trial, hazardous drinkers (n = 516) were identified by the AUDIT screening questionnaire. Intervention included brief clinician advice (30 seconds), a 15-minute motivational session by counselors, and printed materials.\n At six-month follow-up, intervention subjects reported fewer total standard drinks in the past three months (176 versus 216, P = .04, one-tailed) and fewer drinking days per week (2.8 versus 3.3, P = .02) than controls, but similar drinks per drinking day (3.3 versus 3.5; P = .13). At 12 months, intervention subjects again reported fewer drinking days per week (2.7 versus 3.1; P = .04) than controls, but similar numbers of standard drinks (157 versus 179; P = .13) and drinks per drinking day (3.6 versus 3.3; P = .20). Intervention subjects were somewhat more likely than controls to report drinking within daily recommended limits (< or = 3 for men, < or = 2 for women) at both six months (79% versus 71%; P = .06) and 12 months (80% versus 73%; P = .07), but did not differ significantly from controls on other drinking outcomes (percent abstinent, frequency of drinking > or = 6 drinks per drinking occasion, estimated peak blood alcohol concentration), or use of medical care in the year following intervention.\n A one-time, brief motivational intervention using minimal clinician time supplemented by trained counselors resulted in a modest reduction in frequency of alcohol consumption in a busy primary care population. Future research should focus on strengthening and maintaining intervention effects.", "Alcohol use in older adults is common. It is associated with depression, hypertension, diabetes, drug interactions, accidents, and increased rates of emergency department visits and hospitalizations.\n A controlled clinical trial (Project GOAL--Guiding Older Adult Lifestyles) tested the efficacy of brief physician advice in reducing the alcohol use and use of health care services of older adult problem drinkers. Twenty-four community-based primary care practices in Wisconsin (43 family physicians and internists) participated in the trial. Of the 6073 patients screened, 105 men and 53 women met inclusion criteria and were randomized into a control group (n = 71) or an intervention group (n = 87). Intervention group patients received two 10- to 15-minute physician-delivered counseling sessions that included advice, education, and contracting using a scripted workbook. A total of 146 patients (92.4%) participated in the 12-month follow-up procedure.\n No significant differences were found between the control and intervention groups at baseline in alcohol use, age, socioeconomic status, depression, onset of alcohol use, smoking status, activity level, or use of mood-altering drugs. The older adults who received the physician intervention demonstrated a significant reduction in 7-day alcohol use, episodes of binge drinking, and frequency of excessive drinking (P <.005) compared with the control group at 3, 6, and 12 months after the intervention. There was a 34% reduction in 7-day alcohol use, 74% reduction in mean number of binge-drinking episodes, and 62% reduction in the percentage of older adults drinking more than 21 drinks per week in the intervention group compared with the control group. There were no significant changes in health status. Patterns of health care utilization were not extensively analyzed because of the small number of events.\n This study provides the first direct evidence that brief physician advice can decrease alcohol use by older adults in community-based primary care practices.", "Project TrEAT (Trial for Early Alcohol Treatment) was designed to test the efficacy of brief physician advice in reducing alcohol use and health care utilization in problem drinkers.\n Randomized controlled clinical trial with 12-month follow-up.\n A total of 17 community-based primary care practices (64 physicians) located in 10 Wisconsin counties.\n Of the 17695 patients screened for problem drinking, 482 men and 292 women met inclusion criteria and were randomized into a control (n=382) or an experimental (n=392) group. A total of 723 subjects (93%) participated in the 12-month follow-up procedures.\n The intervention consisted of two 10- to 15-minute counseling visits delivered by physicians using a scripted workbook that included advice, education, and contracting information.\n Alcohol use measures, emergency department visits, and hospital days.\n There were no significant differences between groups at baseline on alcohol use, age, socioeconomic status, smoking status, rates of depression or anxiety, frequency of conduct disorders, lifetime drug use, or health care utilization. At the time of the 12-month follow-up, there were significant reductions in 7-day alcohol use (mean number of drinks in previous 7 days decreased from 19.1 at baseline to 11.5 at 12 months for the experimental group vs 18.9 at baseline to 15.5 at 12 months for controls; t=4.33; P<.001), episodes of binge drinking (mean number of binge drinking episodes during previous 30 days decreased from 5.7 at baseline to 3.1 at 12 months for the experimental group vs 5.3 at baseline to 4.2 at 12 months for controls; t=2.81; P<.001), and frequency of excessive drinking (percentage drinking excessively in previous 7 days decreased from 47.5% at baseline to 17.8% at 12 months for the experimental group vs 48.1% at baseline to 32.5% at 12 months for controls; t=4.53; P<.001). The chi2 test of independence revealed a significant relationship between group status and length of hospitalization over the study period for men (P<.01).\n This study provides the first direct evidence that physician intervention with problem drinkers decreases alcohol use and health resource utilization in the US health care system.", "This study aimed at testing the effectiveness of a brief motivational intervention (BI) compared with a minimal intervention (MI) for reducing alcohol consumption in adult, alcohol-positive traffic casualties.\n Patients were recruited at the emergency room of a trauma hospital and screened for alcohol by a qualitative saliva test (positive from a blood alcohol concentration of 0.02 g/l). Positive patients (13.3%) who accepted entering the study were randomly allocated into BI and MI. Baseline assessment was the same for all patients. Blind telephone follow-ups were performed at months 3, 6, and 12, and results were analysed by protocol and by intention-to-treat analysis.\n After 1 year of follow-up, 67% of the patients had reduced their consumption, the percentage of heavy drinkers had dropped by 47%, and 62% of baseline AUDIT-C positive patients (hazardous drinkers) had become negative. Binge drinking dropped significantly (P < 0.05). Results at month 12 were in line with the previous ones.\n The effectiveness of BI compared with MI has not been verified, but a significant reduction in consumption has been observed in the whole sample, without significant differences by type of intervention. The persistence and dimension of changes suggest a real effect of both interventions, although the lack of a pure control group does not allow definitive conclusions. Traffic casualties are in a teachable moments to benefit from easy and cheap interventions.", "Sixteen general practitioners participated in a controlled trial of the Scottish Health Education Group's DRAMS (drinking reasonably and moderately with self-control) scheme. The scheme was evaluated by randomly assigning 104 heavy or problem drinkers to three groups - a group participating in the DRAMS scheme (n = 34), a group given simple advice only (n = 32) and a non-intervention control group (n = 38). Six month follow-up information was obtained for 91 subjects (87.5% of initial sample). There were no significant differences between the groups in reduction in alcohol consumption, but patients in the DRAMS group showed a significantly greater reduction in a logarithmic measure of serum gamma-glutamyl-transpeptidase than patients in the group receiving advice only. Only 14 patients in the DRAMS group completed the full DRAMS procedure. For the sample as a whole, there was a significant reduction in alcohol consumption, a significant improvement on a measure of physical health and well-being, and significant reductions in the logarithmic measure of serum gamma-glutamyl transpeptidase and in mean corpuscular volume. The implications of these findings for future research into controlled drinking minimal interventions in general practice are discussed.", "The project was designed to compare the effectiveness of brief intervention (BI) versus simple advice (SA) in the secondary prevention of hazardous alcohol consumption.\n A randomized controlled trial with a 12-month follow-up was conducted. A total of 74 community-based primary care practices (328 physicians) located in 13 Spanish autonomous regions were recruited initially. Out of 546 men screened, only 229 were randomized into BI (n = 104) and SA (n = 125); 44.6% of practices finalized the study. The interventions on the BI group consisted of a 15-minute counselling visit carried out by physicians which included: (i) alcohol quantification, (ii) information on safe limits, (iii) advice, (iv) drinking limits agreement, (v) self-informative booklet with drinking diary record and (vi) unscheduled reinforcement visits. The SA group spent 5 minutes which included (i), (ii) and (iii).\n There were no significant differences between both groups at baseline on alcohol use, age, socioeconomic status and CAGE score. After the 12-month follow-up there was a significant decrease in frequency of excessive drinkers (67% of BI group reached targeted consumption, versus 44% of SA; P < 0.001) as well as weekly alcohol intake reduction (BI reached 52 versus 32% in SA; P < 0.001). A trend to improve outcome with the number of reinforcement visits was found with BI. The only predictor of success was the initial alcohol consumption level.\n Brief intervention is more effective than simple advice to reduce alcohol intake on adult men who attend primary care services in Spain.", "The study examined the effectiveness of routine intervention in alcohol abuse by a general practitioner, with help of a laboratory test. Patients diagnosed as abusers because of high erythrocyte mean cell volume value (MCV) and having no other cause for it were randomly allocated to two groups: 1) an intervention group, comprising 92 patients (69 men and 23 women), who were invited for follow-up at three-monthly intervals for a year; 2) a control (mini-intervention) group, 86 patients (71 men and 15 women), who were followed-up only after 12 months. Follow-up attendance was poor, particularly in the intervention group. In general, MCV-values were unchanged in the groups at the end of the study, though there was a clear trend for the female controls to have lower values (101.9 fl at the start, 98.5 fl at the end, p = 0.06). Altogether 11% (4/38) of the women and 7% (10/140) of the men had clearly reduced their alcohol consumption after one year, and this was also seen in their MCV-values. Mini-intervention, especially in women with an abnormal laboratory value, seems to be, with the help of MCV, at least as effective a way of counselling nonalcoholic abusers as a more systematic intervention.", "To compare the effects of three brief methods of reducing alcohol consumption among family practice patients.\n Patients randomly assigned to one of three interventions were assessed initially and at 3-, 6-, and 12-month follow-up appointments.\n Family practice clinic composed of 12 primary care physicians seeing approximately 6000 adults monthly in a small urban community, population 40,000.\n Through a screening questionnaire, 134 men and 131 women were identified as hazardous drinkers (five or more drinks at least once monthly) during an 11-month screening of 1420 patients. Of 265 patients approached, 180 agreed to participate and 159 (83 men and 76 women) actually participated in the study.\n Three interventions were studied: brief physician advice (5 minutes), two 30-minute sessions with a physician using cognitive behavioural strategies or two 30-minute sessions with a nurse practitioner using identical strategies.\n Quantity and frequency (QF) of drinking were used to assess reduction in hazardous drinking and problems related to drinking over 12 months of follow up.\n No statistical difference between groups was found. The QF of monthly drinking was reduced overall by 66% (among men) and 74% (among women) for those reporting at least one hazardous drinking day weekly at assessment (N = 96). Men reported drinking significantly more than women.\n These results indicated that offering brief, specific advice can motivate patients to reduce their alcohol intake. There was no difference in effect between brief advice from their own physician or brief intervention by a physician or a nurse.", "This paper reports an evaluation of the effectiveness and cost-effectiveness of nurse-led screening and brief intervention in reducing excessive alcohol consumption among patients in primary health care.\n Excessive alcohol consumption is a major source of social, economic and health problems. However, such consumption is responsive to brief alcohol intervention. To date, brief intervention research in primary health care has focused on general practitioner-led interventions, and there is only circumstantial evidence of effectiveness in nurse-led interventions. However, nurses are increasingly taking a lead in health promotion work in primary care.\n A pragmatic cluster-randomized controlled trial was carried out between August 2000 and June 2003 to evaluate the effects of a brief intervention compared with standard advice (control condition). A total of 40 general practice clusters (intervention = 21 and control = 19) recruited 127 patients (intervention = 67 and control = 60) to the trial. Excessive consumption was identified opportunistically via the Alcohol Use Disorders Identification Test. After baseline assessment, patients received either a 5-10 minutes brief intervention using the 'Drink-Less' protocol or standard advice (control condition). Follow-up occurred at 6 and 12 months postintervention.\n Analysis of variance weighted for cluster size revealed no statistically significant differences between intervention and control patients at follow up. A majority of patients in both conditions reduced their alcohol consumption between assessment and subsequent measurement. Economic analysis suggested that the brief intervention led to no statistically significant changes in subsequent health service resource use relative to standard treatment.\n The brief intervention evaluated in this trial had no effect over standard advice delivered by nurses in primary health care. However, there was a reduction in excessive drinking across both arms of the trial over time. Due to nurse drop-out, this trial was significantly underpowered. Future research should explore barriers to nurses' involvement in research trials, particularly with an alcohol focus. A larger trial is required to evaluate the effectiveness of nurse-led screening and brief alcohol intervention in primary care.", "Female problem drinkers are less likely than men to be identified in the primary care setting. The authors studied 24 adult women attending a general, internal medicine clinic to assess the efficiency of self-reports of alcohol consumption when compared with physician identification and other measures and the impact of a brief intervention on alcohol consumption. Despite the high rate of lifetime (79%) and current (67%) alcohol diagnoses, no patient was in alcohol treatment. Physician identification of alcohol problems was least sensitive but most specific, when compared with other measures. Brief intervention, as offered in this study, did not appear to modify alcohol consumption.", "To evaluate the effectiveness of medical counselling in reducing alcohol consumption in male heavy drinkers.\n A controlled, randomised, simple-blind intervention study.\n Four Primary Care teams in Area 10, Madrid.\n 152 men who attended for on-demand treatment from the four teams and whose alcohol consumption was over 21 International Units (IU) a week.\n Brief medical counselling backed up by didactic material. Two questionnaires on alcohol consumption in IU, consumption habits and problems related to alcohol were administered, separated by an interval of between 6 and 18 months. Non-parametric tests for paired samples (McNemar) were applied.\n 60% answered the second questionnaire. Neither sociodemographic nor health habit differences were found between those who responded and those who did not, except for social class. There were no appreciable differences between the intervention and control groups. The percentage of drinkers above 35 IU decreased significantly in the intervention group.\n The intervention was clearly effective in reducing the percentage of drinkers whose weekly consumption was over 35 IU.", "The study aim was to test whether a brief motivational intervention, with or without a booster session, would improve drinking-related outcomes more than standard Emergency Department (ED) treatment.\n The study population consisted of 539 (78% male) injured patients treated in the ED and discharged to the community following their treatment. Injured patients met inclusion criteria if they were assessed as hazardous or harmful drinkers by scoring eight or more on the AUDIT and/or having alcohol in their system at the time of their injury or ED visit. Patients were randomly assigned to either standard care (SC), brief intervention (BI) or brief intervention plus a booster session (BIB). At 1-year follow-up, 447 patients (83% of the sample) were re-interviewed to measure alcohol-related negative consequences, injuries and drinking.\n Patients receiving BIB, but not B1 patients, reduced alcohol-related negative consequences and alcohol-related injuries more than did those in the SC group. All three groups reduced their days of heavy drinking. Patients with histories of hazardous drinking responded to BIB, whether or not they had consumed alcohol prior to their injury.\n Together, these results indicate that the effects of a booster session that is added to a brief intervention in the ED can be helpful to injured patients with a history of hazardous or harmful drinking, irrespective of whether they have consumed alcohol prior to their injury.", "Alcohol screening and brief intervention (SBI) has gained widespread acceptance as an effective method for reducing problem drinking in at-risk populations. This study examines the cost and cost-effectiveness of an SBI pilot program delivered in an inner-city hospital emergency department (ED) to a traditionally underserved population.\n A total of 1,036 subjects were screened for problem drinking during their visit to an ED. Eligible participants (N = 294) were randomly assigned to either a brief intervention group or a control group. As the result of attrition, a final sample of 194 (90 brief intervention; 104 control) participants remained at follow-up. The intervention consisted of a brief counseling session and a health information packet. The control group received only the packet. Intervention cost data were collected and analyzed using the Drug Abuse Treatment Cost Analysis Program. Selected outcomes at the 3-month follow-up included the raw Alcohol Use Disorders Identification Test score, average weekly number of drinks and engaging in heavy drinking in the past month (>6 drinks on one occasion for men, >4 for women). Outcome differences between the intervention and control groups were estimated with both bivariate and multivariate techniques.\n The average economic cost of the brief intervention was dollars 632 per subject, of which screening (dollars 497) was the largest component. In all cases, intervention subjects had better 3-month outcomes than control subjects, but the differences were not always statistically significant. Cost-effectiveness ratios were relatively small for all three outcomes, suggesting this type of intervention has the potential to be cost-effective under full implementation.\n The preliminary results demonstrate the potential advantage of further research in this area with larger samples and a longer follow-up period.", "Alcohol biomarkers are being developed to improve a physician's ability to identify and intervene with patients with chronic medical problems adversely affected by heavy alcohol use. This article reports the findings of a brief intervention trial which included feedback to patients of their carbohydrate-deficient transferrin (CDT) test results.\n A pilot study was conducted to test the efficacy of brief clinician advice to reduce alcohol use and improve health status in a sample of 151 patients being treated for Type 2 diabetes and hypertension. The intervention included informing patients of their CDT levels. The patients were randomized to a usual care or brief intervention group.\n There were no significant differences at baseline between the two groups in alcohol use, CDT levels, addiction rates, age, gender, socioeconomic status or health status measures. Following brief intervention, significant differences were observed in the intervention group in alcohol use and CDT: The proportion of heavy drinkers at the 12-month follow-up compared with baseline decreased from 35.8% to 24.7% in the intervention group, with no change in the control group (p < .044). CDT levels decreased as well from 2.79% to 2.41% (16% change) in the control group and 3.05% to 2.35% (28% change) in the intervention group, with significantly more intervention-group patients reducing their CDT level by at least 25% (p < .006).\n The study provides new information suggesting brief intervention, combined with feedback on CDT levels, can reduce alcohol use and %CDT in a sample of primary care patients being treated for Type 2 diabetes and hypertension.", "In a controlled evaluation of general practitioner (GP)-based brief intervention, 378 excessive drinkers identified opportunistically by screening in 40 group practices in metropolitan Sydney were assigned to groups receiving: (i) a five-session intervention by the GP (the Alcoholscreen Program); (ii) a single session of 5 minutes' advice by the GP plus a self-help manual (minimal intervention); (iii) an alcohol-related assessment but no intervention; (iv) neither intervention nor assessment. Among all patients allocated to receive it, the Alcoholscreen Program did not result in a significantly greater reduction in consumption at follow-up than control conditions but patients offered Alcoholscreen reported a significantly greater reduction in alcohol-related problems in the period to 6 months follow-up. A greater proportion of patients who returned for the second Alcoholscreen visit were drinking below recommended levels at follow-up than in the remainder of the sample. There was no evidence that minimal intervention or alcohol-related assessment were effective in reducing alcohol consumption or problems. Implications for further research into GP-based brief interventions are discussed.", "Today, heavy drinking is a common health hazard among women. The evidence in favor of providing some kind of brief intervention to reduce drinking is quite convincing. However, we do not know if intervention works in a natural environment of routine health care. The purpose of this study was to evaluate the effectiveness of long-lasting, brief alcohol intervention counseling for women in a routine general practice setting.\n In five primary care outpatient clinics in a Finnish town, 118 female early-phase heavy drinkers who consulted their general practitioners for various reasons were given brief alcohol intervention counseling. Intervention groups A (n = 40) and B (n = 38) were offered seven and three brief intervention sessions, respectively, over a 3-yr period. The control group C (n = 40) was advised to reduce drinking at baseline. Main outcome measures were self-reported weekly alcohol consumption, carbohydrate-deficient transferrin, mean corpuscular volume (MCV), aspartate aminotransferase, alanine aminotransferase, and gamma-glutamyltransferase.\n Depending on the outcome measure and the study group, clinically meaningful reduction of drinking was found in 27% to 75% of the heavy drinkers. Within all the groups, MCV significantly decreased. However, there were no statistically significant differences between study groups A, B, and C in the mean changes between the beginning and endpoint in the main outcome measures.\n The present study indicated that minimal advice, as offered to group C, was associated with reduced drinking as much as the brief intervention, as offered to groups A and B, given over a 3-yr period. Furthermore, in the routine setting of the general practice office, the effectiveness of the brief intervention may not be as good as in special research conditions. The factors possibly reducing the effectiveness in a routine setting are unknown. Thus, different methods of implementing brief intervention need to be evaluated to find better ways to support general practice personnel in their efforts to help heavy-drinking female patients to reduce their drinking.", "To evaluate the effect of a nurse-conducted intervention on excessive drinkers.\n Randomized, controlled trial.\n Vårby Health Centre, Stockholm.\n The intervention group visited a nurse three times during a 12-month period. The controls met once with a general practitioner (GP).\n Patients were recruited at a health screening on the basis of a raised gamma-glutamyl transferase (GGT). Of 2338 subjects, aged 25-54 years, 222 had a screening GGT of > or = 0.9 mukat/l. 100 were randomized to the treatment and 122 to the control group.\n GGT, self-reported alcohol consumption (g/week), sickness allowance and use of health care.\n After 2 years a reduction of GGT from 1.52 to 1.21 mukat/l (p = 0.02) had occurred in the treatment group. The controls increased their mean level of GGT from 1.75 to 2.16 mukat/l. Mean weekly alcohol consumption in the intervention group was reduced from 337 to 228 g/week (p = 0.02). The controls did not quantify their alcohol consumption initially, but reported a reduced weekly consumption at follow-up.\n The intervention had an impact on GGT and self-reported consumption. The controls also reported decreased consumption possibly because their appointment with the GP functioned as a very brief intervention.", "Seventy two women drinking 21 units (210g) or more of alcohol per week were recruited from an opportunistic screening programme in eight English general practices. The women were randomized into control and treatment groups. Women in the treatment group received ten minutes advice from their general practitioner to reduce alcohol consumption. At one year follow-up, when analyzed by intention to treat, women in the treatment group had reduced their alcohol consumption from an average of 35-24 units per week. Similar reductions were found in the control group (from 37-27 units per week). The lack of evidence for a treatment effect may be explained by contamination of the control group by informal interventions.", "Present methods to screen for alcohol abuse are generally obtrusive and result in referral to services that deal mainly with alcoholics. These factors deter physicians from identifying alcohol abuse patients at an early stage. In the present study, 81% of all primary care physicians of a single city evaluated (i) the efficiency and the acceptability of a nonobtrusive screening method for the identification of problem drinkers and (ii) the effectiveness of brief cognitive behavioral counseling given by a nurse in a lifestyle context. Patients (n = 15,686) attending the private practices of 42 primary-care physicians were asked four alcohol-neutral trauma questions in the reception area. Physicians asked about alcohol use and alcohol-related problems only to patients with previous trauma. Problem drinkers by defined criteria were offered an appointment with a nurse who, by random assignment, gave either 3-hr of cognitive behavioral counseling over 1 year or simply advised patients to reduce their alcohol intake. The screening method identified 62-85% of expected number of problem drinkers in this population. Following the application of exclusion criteria, 105 problem drinkers were entered in the intervention part of the study. After 1 year, patients who received counseling showed significant reductions in reported alcohol consumption (-70%; p < 0.001), psychosocial problems (-85%; p < 0.001) and serum gamma glutamyl transferase (-32% to -58%; p < 0.02). Physician visits were reduced (-34%; p < 0.02) following counseling. Patients receiving only advice showed neither reductions in psychosocial problems nor in serum gamma glutamyl transferase or physician visits, but reported a 46% reduction (p < 0.01) in alcohol consumption. Data indicate that asking patients about recent trauma is efficient and is well accepted as the first screening instrument in the identification of the problem drinker. Cost of screening per patient is under one dollar. Counseling of 3 hr given by a nurse is markedly superior (p < 0.05) to simple advice in reducing alcohol consumption, objective indicators of alcohol-related morbidity, and the frequency of physician visits.", "There is a need for primary care providers to have brief effective methods to intervene with high-risk drinkers during a regular outpatient visit.\n To determine whether brief physician- and nurse practitioner-delivered counseling intervention is efficacious as part of routine primary care in reducing alcohol consumption by high-risk drinkers.\n Academic medical center-affiliated primary care practice sites were randomized to special intervention or to usual care. From a screened population of 9772 patients seeking routine medical care with their primary care providers, 530 high-risk drinkers were entered into the study. Special intervention included training providers in a brief (5- to 10-minute) patient-centered counseling intervention, and an office support system that screened patients, cued providers to intervene, and made patient education materials available. The primary outcome measures were change in alcohol use from baseline to 6 months as measured by weekly alcohol consumption and frequency of binge drinking episodes.\n Participants in the special intervention and usual care groups were similar on important background variables and potential confounders except that special intervention participants had significantly higher baseline levels of alcohol usage (P = .01). At 6-month follow-up, in the 91% of the cohort who provided follow-up information, alcohol consumption was significantly reduced when adjusted for age, sex, and baseline alcohol usage (special intervention, -5.8 drinks per week; usual care, -3.4 drinks per week; P = .001).\n This study provides evidence that screening and very brief (5- to 10-minute) advice and counseling delivered by a physician or nurse practitioner as part of routine primary care significantly reduces alcohol consumption by high-risk drinkers.", "Alcoholism is the leading risk factor for injury. The authors hypothesized that providing brief alcohol interventions as a routine component of trauma care would significantly reduce alcohol consumption and would decrease the rate of trauma recidivism.\n This study was a randomized, prospective controlled trial in a level 1 trauma center. Patients were screened using a blood alcohol concentration, gamma glutamyl transpeptidase level, and short Michigan Alcoholism Screening Test (SMAST). Those with positive results were randomized to a brief intervention or control group. Reinjury was detected by a computerized search of emergency department and statewide hospital discharge records, and 6- and 12-month interviews were conducted to assess alcohol use.\n A total of 2524 patients were screened; 1153 screened positive (46%). Three hundred sixty-six were randomized to the intervention group, and 396 to controls. At 12 months, the intervention group decreased alcohol consumption by 21.8+/-3.7 drinks per week; in the control group, the decrease was 6.7+/-5.8 (p = 0.03). The reduction was most apparent in patients with mild to moderate alcohol problems (SMAST score 3 to 8); they had 21.6+/-4.2 fewer drinks per week, compared to an increase of 2.3+/-8.3 drinks per week in controls (p < 0.01). There was a 47% reduction in injuries requiring either emergency department or trauma center admission (hazard ratio 0.53, 95% confidence interval 0.26 to 1.07, p = 0.07) and a 48% reduction in injuries requiring hospital admission (3 years follow-up).\n Alcohol interventions are associated with a reduction in alcohol intake and a reduced risk of trauma recidivism. Given the prevalence of alcohol problems in trauma centers, screening, intervention, and counseling for alcohol problems should be routine.", "This randomized trial evaluated an intervention for reducing at-risk drinking practices in a sample of 307 patients. Eligible drinking patterns included chronic drinking (> or = 2 drinks per day in the past month), binge drinking (> or = 5 drinks per occasion at least twice in the past month), and drinking and driving (driving after > 2 drinks in the past month). Members of the intervention group received a message from their physician during their regularly scheduled visit, a self-help manual, written personalized feedback, and up to 3 telephone counseling calls. Dropout was significantly higher in the intervention than control group." ]

[ "18204830", "19108786", "19565569", "20200301" ]

[ "A randomised, 52-week, treat-to-target trial comparing insulin detemir with insulin glargine when administered as add-on to glucose-lowering drugs in insulin-naive people with type 2 diabetes.", "A 52-week, multinational, open-label, parallel-group, noninferiority, treat-to-target trial comparing insulin detemir with insulin glargine in a basal-bolus regimen with mealtime insulin aspart in patients with type 2 diabetes.", "Comparison of insulin detemir and insulin glargine using a basal-bolus regimen in a randomized, controlled clinical study in patients with type 2 diabetes.", "A 24-week, randomized, treat-to-target trial comparing initiation of insulin glargine once-daily with insulin detemir twice-daily in patients with type 2 diabetes inadequately controlled on oral glucose-lowering drugs." ]

[ "This 52-week multinational, randomised, open-label, parallel-group, non-inferiority trial compared clinical outcomes following supplementation of oral glucose-lowering drugs with basal insulin analogues detemir and glargine in type 2 diabetic patients.\n Insulin-naive adults (n=582, HbA(1c) 7.5-10.0%, BMI <or= 40.0 kg/m(2)) were randomised 1:1 to receive insulin detemir or glargine once daily (evening) actively titrated to target fasting plasma glucose (FPG) <or= 6.0 mmol/l. An additional morning insulin detemir dose was permitted if pre-dinner plasma glucose (PG) was >7.0 mmol/l after achieving FPG <7.0 mmol/l. Due to labelling restrictions, no second glargine dose was allowed.\n Baseline HbA(1c) decreased from 8.6 to 7.2 and 7.1% (NS) with detemir and glargine, respectively. FPG improved from 10.8 to 7.1 and 7.0 mmol/l (NS), respectively. With detemir, 45% of participants completed the study on once daily dosing and 55% on twice daily dosing, with no difference in HbA(1c). Overall, 52% of participants achieved HbA(1c) <or= 7.0%: 33% (detemir) and 35% (glargine) without hypoglycaemia. Within-participant variability for self-monitored FPG and pre-dinner PG did not differ by insulin treatment, nor did the relative risk of overall or nocturnal hypoglycaemia. Modest reductions in weight gain were seen with detemir vs glargine in completers (3.0 vs 3.9 kg, p=0.01) and in the intention-to-treat population (2.7 vs 3.5 kg, p=0.03), primarily related to completers on once-daily detemir. Mean daily detemir dose was higher (0.78 U/kg [0.52 with once daily dosing, 1.00 U/kg with twice daily dosing]) than glargine (0.44 IU/kg). Injection site reactions were more frequent with detemir (4.5 vs 1.4%).\n Supplementation of oral agents with detemir or glargine achieves clinically important improvements in glycaemic control with low risk of hypoglycaemia. Non-inferiority was demonstrated for detemir using higher insulin doses (mainly patients on twice daily dosing); weight gain was somewhat reduced with once daily insulin detemir.", "This trial compared the efficacy and safety profiles of the insulin analogues detemir and glargine as the basal insulin component of a basal-bolus regimen in patients with type 2 diabetes mellitus (T2DM) who were being treated with oral antidiabetic drugs (OADs) or insulin with or without OADs.\n This was a multinational, 52-week, openlabel, parallel-group, noninferiority, treat-to-target trial. Patients with a diagnosis of T2DM for > or = 12 months who had been receiving an OAD or insulin, with or without OADs, for > 4 months were randomized in a 2:1 ratio to receive detemir or glargine. According to the approved labeling, detemir could be administered once or twice daily, and glargine was administered once daily. Insulin aspart was given at mealtimes. Insulin secretagogues and a-glucosidase inhibitors were discontinued at study entry, and existing OADs were continued. Doses of detemir and glargine were titrated to achieve a prebreakfast (and predinner for detemir administered twice daily) plasma glucose target of < or = 6.0 mmol/L. Patients monitored their plasma glucose levels before breakfast and dinner on the 3 days before each of 13 scheduled visits, recorded their insulin doses on 1 of these 3 days, and recorded their 10-point self-monitored plasma glucose (SMPG) at baseline and after 24 and 52 weeks. The primary efficacy end point was glycosylated hemoglobin (HbA(1c)) at 52 weeks; secondary efficacy end points included changes in fasting plasma glucose (FPG), postprandial plasma glucose, insulin doses, and weight change at 52 weeks. Safety end points included the frequency of hypoglycemia and adverse events (AEs).\n The intention-to-treat population included 319 patients (58.0% male, 42.0% female; 78.4% white; mean age, 58 years; mean weight, 92.8 kg; mean duration of diabetes, 13.6 years). At study entry, 46.1% of patients were receiving insulin and > or = 1 OAD, 35.4 were receiving insulin only, and 18.5% were receiving > or = 1 OAD only. At 52 weeks, there was no significant difference between detemir and glargine in terms of mean HbA(1c) (7.19% and 7.03%, respectively; mean difference, 0.17% [95% CI, -0.07 to 0.40]) or the mean decrease in HbAlc from baseline (-1.52% and -1.68%). The reduction in HbA(1c) was not significantly affected by whether detemir was administered once or twice daily. There were no significant differences between groups in terms of mean FPG (7.05 and 6.68 mmol/L) or the mean change in FPG from baseline (-2.56 and -2.92 mmol/L; mean difference, 0.36; 95% CI, -0.26 to 0.99). The overall shape of the 10-point SMPG profiles was not significantly different between groups. Mean weight gain at 52 weeks was significantly lower with detemir than with glargine (2.8 vs 3.8 kg; mean difference, -1.04; 95% CI, -2.08 to -0.01; P < 0.05). Doses of basal and prandial insulins at the end of the study were not significantly different between groups. Major hypoglycemic episodes were reported by 4.7% and 5.7% of patients in the respective treatment groups. There was no significant difference in the risk of hypoglycemia between groups. The proportion of patients with AEs and the number of AEs per patient were comparable between groups (185/214 patients [86.4%] reporting 743 AEs and 88/105 patients [83.8%] reporting 377 AEs).\n when used as indicated as part of a basal-bolus regimen in patients with T2DM who had previously received other insulin and/or OAD regimens, detemir was noninferior to glargine in its effects on overall glycemic control. Both basal insulins were associated with clinically relevant reductions in hyperglycemia. Both were well tolerated, with no significant difference in the frequency of hypoglycemia or AEs.", "This treat-to-target study compared the efficacy and safety of insulin detemir (IDet) and insulin glargine (IGla) in a basal-bolus (insulin aspart) regimen in type 2 diabetes.\n 385 patients were randomized 2 : 1 (IDet : IGla). Non-inferiority of IDet to IGla was determined by HbA(1c) 95% CI upper limit <0.4.\n IDet and IGla showed similar efficacy in HbA(1c) reduction at 26 weeks, as the non-inferiority criterion was met at 26 weeks (LS mean [Det-Gla]: 0.207; 95% CI: 0.0149,0.3995). It appeared that IGla in some cases did better than IDet in terms of HbA(1c), but the difference (0.207%) was not clinically meaningful. Based on the CONSORT guideline, non-inferiority analysis using the LOCF approach was inconclusive regarding possible inferiority of delta 0.4 (LS mean of [Det-Gla]: 0.307; 95% CI: 0.1023, 0.5109). HbA(1c) decreased significantly from baseline in IDet (-1.1% [26 weeks], -0.9% [LOCF], p < 0.001) and in IGla (-1.3% [26 weeks, LOCF], p < 0.001). Final HbA(1c) were 7.1% (26 weeks) and 7.3% (LOCF) in IDet, and 6.9% (26 weeks) and 7.0% (LOCF) in IGla. Final FPG were 130 mg/dL (26 weeks) and 135 mg/dL (LOCF) in IDet, and 134 mg/dL (26 weeks) and 137 mg/dL (LOCF) in IGla. There was significantly less weight gain in IDet-treated patients (1.2 +/- 3.96 kg versus 2.7 +/- 3.94 kg, p = 0.001). Hypoglycemia risk was comparable between groups. The majority of IDet-treated patients (87.4%) remained on a once-daily basal insulin regimen throughout the study.\n IDet and IGla were both effective and safe treatments for glycemic control in a basal-bolus regimen for type 2 diabetes. Clinically significant reductions in HbA(1c) were achieved in both groups, but with significantly less weight gain in the IDet group at comparable basal insulin dosage.", "To determine whether glargine is noninferior to detemir regarding the percentage of patients reaching A1C <7% without symptomatic hypoglycemia <or=3.1 mmol/l.\n In this 24-week trial, 973 insulin-naive type 2 diabetic patients on stable oral glucose-lowering drugs with A1C 7.0-10.5% were randomized to glargine once daily or detemir twice daily. Insulin doses were systematically titrated. RESULTS 27.5 and 25.6% of patients reached the primary outcome with glargine and detemir, respectively, demonstrating the noninferiority of glargine. Improvements in A1C were -1.46 +/- 1.09% for glargine and -1.54 +/- 1.11% for detemir (P = 0.149), with similar proportions of patients achieving A1C <7% (P = 0.254) but more detemir-treated patients reaching A1C <6.5% (P = 0.017). Hypoglycemia risk was similar. Weight gain was higher for glargine (difference: 0.77 kg, P < 0.001). Glargine doses were lower than detemir doses: 43.5 +/- 29.0 vs. 76.5 +/- 50.5 units/day (P < 0.001).\n In insulin-naive type 2 diabetic patients, glargine reached similar control as detemir, with more weight gain, but required significantly lower doses." ]

[ "17604311", "10929448", "1514335", "18415453", "17075849", "10378713", "11914160", "15611487", "15077933", "16818924", "15494348", "15100594", "11471578", "17699546", "16005336", "7727550" ]

[ "Severe knee osteoarthritis: a randomized controlled trial of acupuncture, physiotherapy (supervised exercise) and standard management for patients awaiting knee replacement.", "[Effect of needle acupuncture on pain perception and functional impairment of patients with coxarthrosis].", "Acupuncture treatment of severe knee osteoarthrosis. A long-term study.", "[Acupuncture treatment for the relief of gonarthrosis pain-a controlled clinical trial.].", "Acupuncture in patients with osteoarthritis of the knee or hip: a randomized, controlled trial with an additional nonrandomized arm.", "A randomized trial of acupuncture as an adjunctive therapy in osteoarthritis of the knee.", "Electroacupuncture versus diclofenac in symptomatic treatment of osteoarthritis of the knee: a randomized controlled trial.", "Effectiveness of acupuncture as adjunctive therapy in osteoarthritis of the knee: a randomized, controlled trial.", "The effect of acupuncture on the symptoms of knee osteoarthritis--an open randomised controlled study.", "Acupuncture and knee osteoarthritis: a three-armed randomized trial.", "Acupuncture as a complementary therapy to the pharmacological treatment of osteoarthritis of the knee: randomised controlled trial.", "Comparison between electro-acupuncture and hydrotherapy, both in combination with patient education and patient education alone, on the symptomatic treatment of osteoarthritis of the hip.", "A comparison of acupuncture with advice and exercises on the symptomatic treatment of osteoarthritis of the hip--a randomised controlled trial.", "Acupuncture as an adjunct to exercise based physiotherapy for osteoarthritis of the knee: randomised controlled trial.", "Acupuncture in patients with osteoarthritis of the knee: a randomised trial.", "Acupuncture for the treatment of pain of osteoarthritic knees." ]

[ "To evaluate the effects of standardized western acupuncture and physiotherapy on pain and functional ability in patients with severe osteoarthritic knee pain awaiting knee arthroplasty.\n Three-arm, assessor-blind, randomized controlled trial. Participants: 181 patients awaiting knee arthroplasty. Interventions: acupuncture for 6 weeks; physiotherapy for 6 weeks; standardized advice. Main outcome measures: Oxford Knee Score questionnaire (OKS) (primary); 50 m timed walk, and duration of hospital stay following knee arthroplasty.\n There was no baseline difference between groups. At 7 weeks, there was a 10% reduction in OKS in the acupuncture group which was a significant difference between the acupuncture and the control group: Mean (s.d.) acupuncture 36.8 (7.20); physiotherapy 39.2 (8.22); control 40.3 (8.48) (P = 0.0497). These effects were no longer present at 12 weeks. There was a trend (P = 0.0984) towards a shorter in-patient stay of 1 day for the physiotherapy group [mean 6.50 days (s.d. 2.0)] compared with the acupuncture group [mean 7.77 days (s.d. 3.96)].\n We have demonstrated that patients with severe knee osteoarthritis can achieve a short-term reduction in OKS when treated with acupuncture. However, we failed to demonstrate any other clinically or statically significant effects between the groups. Both interventions can be delivered effectively in an out-patient group setting at a district general hospital. Further study is needed to evaluate the combined effects of these treatments.", "The effectiveness of acupuncture treatment in patients with osteoarthritis of the hip was tested.\n This is a prospective, randomized, controlled patient and examiner blinded clinical trial.\n The study was performed at a university department for physical medicine and rehabilitation. Sixty-seven patients were separated into two treatment groups.\n Group 1 (treatment) had traditional needle placement and manipulation, whereas in group 2 (control) needles were placed away from classic positions and not manipulated. In both groups needles were placed within the L2 to L5 dermatomes. Endpoints were pain (VAS), functional impairment (hip score), activity of daily living (ADL) and overall satisfaction before treatment, 2 weeks and 2 months post-intervention.\n For all endpoints there was a significant improvement in both groups 2 weeks and 2 months following treatment versus baseline, but no significant difference between the two treatment groups.\n We conclude from these results that needle placement in the area of the affected hip by itself improves symptoms of osteoarthritis. It appears to be less important to follow the rules of traditional acupuncture techniques.", "Acupuncture treatment of patients waiting for arthroplasty surgery.\n 29 patients with a total of 42 osteoarthritic knees were randomized to two groups. Group A was treated while Group B served as a no-treatment control group. After 9 weeks Group B was treated too. Analgesic consumption, pain and objective measurements were registered. All objective measures were done by investigators who were \"blinded\" as to Group A & B. In the second part of the study 17 patients (26 knees) continued with treatments once a month. Registration of analgesic consumption, pain and objective measurements continued. Total study period 49 weeks.\n Comparing Group A to B there was a significant reduction in pain, analgesic consumption and in most objective measures. In Group A + B combined there was an 80% subjective improvement, and a significantly increased knee range movement - an increase mainly in the worst knees. Results were significantly better in those who had not been ill for a long time. In the second part of the study, it was shown that it was possible to maintain the improvements.\n Acupuncture can ease the discomfort while waiting for an operation and perhaps even serve as an alternative to surgery. Seven patients have responded so well that at present they do not want an operation. (USD 9000 saved per operation).", "The analgesic effect of acupuncture in chronic gonarthrosis pain was studied in a placebocontrolled trial completed by 97 patients. Each patient was treated twice a week, receiving 10 acupuncture treatments in all. Before and after tee course of treatment all patients were examined by an unbiased independent examiner and the overall pain score was measured over 10 days using VAS scales; functional parameters (resilience) were measured with a modified Lysholm questionnaire. Patients in the verum group (n=71) were treated according to generally accepted acupuncture treatment recommendations. Patients in the placebo group (n=26) were treated with sham acupuncture at non-acupuncture points on the homolateral leg. A follow-up examination was carried out after 3 months. After ten treatments the overall reduction in pain score was 47.5% in the verum group (follow-up 48.2%), and 26.1% in the placebo group (follow-up 26.1%). The results are statistically significant (P<0.05); they show that in gonarthrosis pain the analgesic effect of verum acupuncture exceeds that of placebo acupuncture. Measurement of the functional parameters according to the Lysholm score showed no significant change.", "To investigate the effectiveness of acupuncture in addition to routine care, compared with routine care alone, in the treatment of patients with chronic pain due to osteoarthritis (OA) of the knee or hip.\n In a randomized, controlled trial, patients with chronic pain due to OA of the knee or hip were randomly allocated to undergo up to 15 sessions of acupuncture in a 3-month period or to a control group receiving no acupuncture. Another group of patients who did not consent to randomization underwent acupuncture treatment. All patients were allowed to receive usual medical care in addition to the study treatment. Clinical OA severity (Western Ontario and McMaster Universities Osteoarthritis Index [WOMAC]) and health-related quality of life (Short Form 36) were assessed at baseline and after 3 months and 6 months.\n Of 3,633 patients (mean +/- SD age 61.8 +/- 10.8 years; 61% female), 357 were randomized to the acupuncture group and 355 to the control group, and 2,921 were included in the nonrandomized acupuncture group. At 3 months, the WOMAC had improved by a mean +/- SEM of 17.6 +/- 1.0 in the acupuncture group and 0.9 +/- 1.0 in the control group (3-month scores 30.5 +/- 1.0 and 47.3 +/- 1.0, respectively [difference in improvement 16.7 +/- 1.4; P < 0.001]). Similarly, quality of life improvements were more pronounced in the acupuncture group versus the control group (P < 0.001). Treatment success was maintained through 6 months. The changes in outcome in nonrandomized patients were comparable with those in randomized patients who received acupuncture.\n These results indicate that acupuncture plus routine care is associated with marked clinical improvement in patients with chronic OA-associated pain of the knee or hip.", "The purpose of this study was to investigate the efficacy of acupuncture as an adjunctive therapy to standard care for the relief of pain and dysfunction in elderly patients with osteoarthritis (OA) of the knee.\n Seventy-three patients with symptomatic OA of the knee were randomly assigned to treatment (acupuncture) or standard care (control). Analysis was performed on last score carried forward to account for patients who dropped out before completion. Patients self-scored Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) and Lequesne indices at baseline and at 4, 8 and 12 weeks. Patients in the control group were offered acupuncture treatment after 12 weeks. The data for these patients are pooled with those from the original acupuncture group for within-group analysis.\n Patients randomized to acupuncture improved on both WOMAC and Lequesne indices compared to those who received standard treatment alone. Significant differences on total WOMAC Scale were seen at 4 and 8 weeks. There appears to be a slight decline in effect at 4 weeks after cessation of treatment (12 weeks after first treatment). No adverse effects of acupuncture were reported.\n These data suggest that acupuncture is an effective and safe adjunctive therapy to conventional care for patients with OA of the knee.", "The purpose of this study was to compare the efficacy of electroacupuncture (EA), diclofenac and their combination in symptomatic treatment of osteoarthritis (OA) of the knee.\n This study was a randomized, single-blind, placebo controlled trial. The 193 out-patients with OA of the knee were randomized into four groups: placebo, diclofenac, EA and combined (diclofenac plus EA). Paracetamol tablets were prescribed as a rescue analgesic during the study. The patients were evaluated after a run-in period of one week (week 0) and again at the end of the study (week 4). The clinical assessments included the amount of paracetamol taken/week, visual analog scale (VAS), Western Ontario and McMaster Universities (WOMAC) OA Index, Lequesne's functional index, 50 feet-walk time, and the orthopedist's and patient's opinion of change.\n One hundred and eighty six patients completed the study. The improvement of symptoms (reduction in mean changes) in most outcome parameters was greatest in the EA group. The proportions of responders and patients with an overall opinion of \"much better\" were also greatest in the EA group. The improvement in VAS was significantly different between the EA and placebo group as well as the EA and diclofenac group. The improvement in Lequesne's functional index also differed significantly between the EA and placebo group. In addition, there was a significant improvement in WOMAC pain index between the combined and placebo group.\n EA is significantly more effective than placebo and diclofenac in the symptomatic treatment of OA of the knee in some circumstances. However, the combination of EA and diclofenac treatment was no more effective than EA treatment alone.", "Evidence on the efficacy of acupuncture for reducing the pain and dysfunction of osteoarthritis is equivocal.\n To determine whether acupuncture provides greater pain relief and improved function compared with sham acupuncture or education in patients with osteoarthritis of the knee.\n Randomized, controlled trial.\n Two outpatient clinics (an integrative medicine facility and a rheumatology facility) located in academic teaching hospitals and 1 clinical trials facility.\n 570 patients with osteoarthritis of the knee (mean age [+/-SD], 65.5 +/- 8.4 years).\n 23 true acupuncture sessions over 26 weeks. Controls received 6 two-hour sessions over 12 weeks or 23 sham acupuncture sessions over 26 weeks.\n Primary outcomes were changes in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain and function scores at 8 and 26 weeks. Secondary outcomes were patient global assessment, 6-minute walk distance, and physical health scores of the 36-Item Short-Form Health Survey (SF-36).\n Participants in the true acupuncture group experienced greater improvement in WOMAC function scores than the sham acupuncture group at 8 weeks (mean difference, -2.9 [95% CI, -5.0 to -0.8]; P = 0.01) but not in WOMAC pain score (mean difference, -0.5 [CI, -1.2 to 0.2]; P = 0.18) or the patient global assessment (mean difference, 0.16 [CI, -0.02 to 0.34]; P > 0.2). At 26 weeks, the true acupuncture group experienced significantly greater improvement than the sham group in the WOMAC function score (mean difference, -2.5 [CI, -4.7 to -0.4]; P = 0.01), WOMAC pain score (mean difference, -0.87 [CI, -1.58 to -0.16];P = 0.003), and patient global assessment (mean difference, 0.26 [CI, 0.07 to 0.45]; P = 0.02).\n At 26 weeks, 43% of the participants in the education group and 25% in each of the true and sham acupuncture groups were not available for analysis.\n Acupuncture seems to provide improvement in function and pain relief as an adjunctive therapy for osteoarthritis of the knee when compared with credible sham acupuncture and education control groups.", "Using an open randomised controlled study, we examined the effectiveness of manual and electroacupuncture on symptom relief for patients with osteoarthritis of the knee.\n Patients with symptomatic osteoarthritis of the knee were randomised to one of three treatment groups. Group A had acupuncture alone, group B had acupuncture but continued on their symptomatic medication, and group C used their symptomatic medication for the first five weeks and then had a course of acupuncture added. Patients receiving acupuncture were treated twice weekly over five weeks. Needles were inserted (with manual and electrical stimulation) in acupuncture points for pain and stiffness, selected according to traditional acupuncture theory for treating Bi syndrome. Patients were assessed by a blinded observer before treatment, after five weeks' treatment and at one month follow up, using a visual analogue pain scale (VAS) and the Western Ontario McMaster (WOMAC) questionnaire for osteoarthritis of the knee.\n The 30 patients in our study were well matched for age, body mass index, disease duration, baseline VAS pain score and baseline WOMAC scores. Repeated measure analyses gave a highly significant improvement in pain (VAS) after the courses of acupuncture in groups A (P = 0.012) and B (P=0.001); there was no change in group C until after the course of acupuncture, when the improvement was significant (P = 0.001). Similarly significant changes were seen with the WOMAC pain and stiffness scores. These benefits were maintained during the one month after the course of acupuncture. Patients' rating of global assessment was higher than that of the acupuncturist.\n We conclude that manual and electroacupuncture causes a significant improvement in the symptoms of osteoarthritis of the knee, either on its own or as an adjunct therapy, with no loss of benefit after one month.", "Despite the popularity of acupuncture, evidence of its efficacy for reducing pain remains equivocal.\n To assess the efficacy and safety of traditional Chinese acupuncture (TCA) compared with sham acupuncture (needling at defined nonacupuncture points) and conservative therapy in patients with chronic pain due to osteoarthritis of the knee.\n Randomized, controlled trial.\n 315 primary care practices staffed by 320 practitioners with at least 2 years' experience in acupuncture.\n 1007 patients who had had chronic pain for at least 6 months due to osteoarthritis of the knee (American College of Rheumatology [ACR] criteria and Kellgren-Lawrence score of 2 or 3). Interventions: Up to 6 physiotherapy sessions and as-needed anti-inflammatory drugs plus 10 sessions of TCA, 10 sessions of sham acupuncture, or 10 physician visits within 6 weeks. Patients could request up to 5 additional sessions or visits if the initial treatment was viewed as being partially successful.\n Success rate, as defined by at least 36% improvement in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score at 26 weeks. Additional end points were WOMAC score and global patient assessment.\n Success rates were 53.1% for TCA, 51.0% for sham acupuncture, and 29.1% for conservative therapy. Acupuncture groups had higher success rates than conservative therapy groups (relative risk for TCA compared with conservative therapy, 1.75 [95% CI, 1.43 to 2.13]; relative risk for sham acupuncture compared with conservative therapy, 1.73 [CI, 1.42 to 2.11]). There was no difference between TCA and sham acupuncture (relative risk, 1.01 [CI, 0.87 to 1.17]).\n There was no blinding between acupuncture and traditional therapy and no monitoring of acupuncture compliance with study protocol. In general, practitioner-patient contacts were less intense in the conservative therapy group than in the TCA and sham acupuncture groups.\n Compared with physiotherapy and as-needed anti-inflammatory drugs, addition of either TCA or sham acupuncture led to greater improvement in WOMAC score at 26 weeks. No statistically significant difference was observed between TCA and sham acupuncture, suggesting that the observed differences could be due to placebo effects, differences in intensity of provider contact, or a physiologic effect of needling regardless of whether it is done according to TCA principles.", "To analyse the efficacy of acupuncture as a complementary therapy to the pharmacological treatment of osteoarthritis of the knee, with respect to pain relief, reduction of stiffness, and increased physical function during treatment; modifications in the consumption of diclofenac during treatment; and changes in the patient's quality of life.\n Randomised, controlled, single blind trial, with blinded evaluation and statistical analysis of results.\n Pain management unit in a public primary care centre in southern Spain, over a period of two years.\n 97 outpatients presenting with osteoarthritis of the knee.\n Patients were randomly separated into two groups, one receiving acupuncture plus diclofenac (n = 48) and the other placebo acupuncture plus diclofenac (n = 49).\n The clinical variables examined included intensity of pain as measured by a visual analogue scale; pain, stiffness, and physical function subscales of the Western Ontario and McMaster Universities (WOMAC) osteoarthritis index; dosage of diclofenac taken during treatment; and the profile of quality of life in the chronically ill (PQLC) instrument, evaluated before and after the treatment programme.\n 88 patients completed the trial. In the intention to treat analysis, the WOMAC index presented a greater reduction in the intervention group than in the control group (mean difference 23.9, 95% confidence interval 15.0 to 32.8) The reduction was greater in the subscale of functional activity. The same result was observed in the pain visual analogue scale, with a reduction of 26.6 (18.5 to 34.8). The PQLC results indicate that acupuncture treatment produces significant changes in physical capability (P = 0.021) and psychological functioning (P = 0.046). Three patients reported bruising after the acupuncture sessions.\n Acupuncture plus diclofenac is more effective than placebo acupuncture plus diclofenac for the symptomatic treatment of osteoarthritis of the knee.", "The aim of the study was to evaluate the therapeutic effect of electro-acupuncture (EA) and hydrotherapy, both in combination with patient education or with patient education alone, in the treatment of osteoarthritis in the hip.\n Forty-five patients, aged 42-86 years, with radiographic changes consistent with osteoarthritis in the hip, pain related to motion, pain on load, and ache were chosen. They were randomly allocated to EA, hydrotherapy, both in combination with patient education, or patient education alone. Outcome measures were the disability rating index (DRI), global self-rating index (GSI), and visual analogue scale (VAS). Assessments were done before the intervention and immediately after the last treatment and 1, 3, and 6 months after the last treatment.\n Pain related to motion and pain on load was reduced up to 3 months after last the treatment in the hydrotherapy group and up to 6 months in the EA group. Ache during the day was significantly improved in both the EA and hydrotherapy group up to 3 months after the last treatment. Ache during the night was reduced in the hydrotherapy group up to 3 months after the last treatment and in the EA group up to 6 months after. Disability in functional activities was improved in EA and hydrotherapy groups up to 6 months after the last treatment. Quality of life was also improved in EA and hydrotherapy groups up to 3 months after the last treatment. There were no changes in the education group alone.\n In conclusion, EA and hydrotherapy, both in combination with patient education, induce long-lasting effects, shown by reduced pain and ache and by increased functional activity and quality of life, as demonstrated by differences in the pre- and post-treatment assessments.", "Acupuncture is becoming a common technique within the physiotherapy profession as a treatment modality for pain relief; however, few randomised controlled trials have been undertaken to assess the effectiveness of acupuncture, particularly in the treatment of osteoarthritis (OA) of the hip. Therefore, a randomised trial to compare the effectiveness of acupuncture with advice and exercises on the symptomatic treatment of OA of the hip was carried out. Thirty-two patients awaiting a total hip arthroplasty were randomly allocated to either the experimental group, (A), to have six sessions of acupuncture each lasting up to 25 minutes, or the control group, (B), to be given advice and exercises for their hip over a six week period. Group A consisted of three men and 13 women, and group B consisted of four men and eight women. The average age in group A was 66 years and in group B it was 68 years. Patients were assessed for pain and functional ability, using a modified version of the WOMAC questionnaire, pre-treatment, immediately post-treatment and at eight weeks post-treatment. The pre-treatment WOMAC scores in the two groups were similar (p=0.85). There was a significant improvement in group A (decrease in WOMAC score) immediately post-treatment (p=0.002) and this was maintained at the eight-week follow-up (p=0.03). There were no significant changes in group B. When the changes in WOMAC scores were compared between groups, a significantly greater improvement was found between pre-treatment and immediately post-treatment in group A, compared with group B (p=0.02). The changes between pre-treatment and the eight-week follow-up also showed a significant improvement in group A compared with group B (p=0.03). In conclusion, this trial supports the hypothesis that acupuncture is more effective than advice and exercises in the symptomatic treatment of OA of the hip.", "To investigate the benefit of adding acupuncture to a course of advice and exercise delivered by physiotherapists for pain reduction in patients with osteoarthritis of the knee.\n Multicentre, randomised controlled trial.\n 37 physiotherapy centres accepting primary care patients referred from general practitioners in the Midlands, United Kingdom.\n 352 adults aged 50 or more with a clinical diagnosis of knee osteoarthritis.\n Advice and exercise (n=116), advice and exercise plus true acupuncture (n=117), and advice and exercise plus non-penetrating acupuncture (n=119).\n The primary outcome was change in scores on the Western Ontario and McMaster Universities osteoarthritis index pain subscale at six months. Secondary outcomes included function, pain intensity, and unpleasantness of pain at two weeks, six weeks, six months, and 12 months.\n Follow-up rate at six months was 94%. The mean (SD) baseline pain score was 9.2 (3.8). At six months mean reductions in pain were 2.28 (3.8) for advice and exercise, 2.32 (3.6) for advice and exercise plus true acupuncture, and 2.53 (4.2) for advice and exercise plus non-penetrating acupuncture. Mean differences in change scores between advice and exercise alone and each acupuncture group were 0.08 (95% confidence interval -1.0 to 0.9) for advice and exercise plus true acupuncture and 0.25 (-0.8 to 1.3) for advice and exercise plus non-penetrating acupuncture. Similar non-significant differences were seen at other follow-up points. Compared with advice and exercise alone there were small, statistically significant improvements in pain intensity and unpleasantness at two and six weeks for true acupuncture and at all follow-up points for non-penetrating acupuncture.\n The addition of acupuncture to a course of advice and exercise for osteoarthritis of the knee delivered by physiotherapists provided no additional improvement in pain scores. Small benefits in pain intensity and unpleasantness were observed in both acupuncture groups, making it unlikely that this was due to acupuncture needling effects.\n Current Controlled Trials ISRCTN88597683 [controlled-trials.com] .", "Acupuncture is widely used by patients with chronic pain although there is little evidence of its effectiveness. We investigated the efficacy of acupuncture compared with minimal acupuncture and with no acupuncture in patients with osteoarthritis of the knee.\n Patients with chronic osteoarthritis of the knee (Kellgren grade < or =2) were randomly assigned to acupuncture (n=150), minimal acupuncture (superficial needling at non-acupuncture points; n=76), or a waiting list control (n=74). Specialised physicians, in 28 outpatient centres, administered acupuncture and minimal acupuncture in 12 sessions over 8 weeks. Patients completed standard questionnaires at baseline and after 8 weeks, 26 weeks, and 52 weeks. The primary outcome was the Western Ontario and McMaster Universities Osteoarthritis (WOMAC) index at the end of week 8 (adjusted for baseline score). All main analyses were by intention to treat.\n 294 patients were enrolled from March 6, 2002, to January 17, 2003; eight patients were lost to follow-up after randomisation, but were included in the final analysis. The mean baseline-adjusted WOMAC index at week 8 was 26.9 (SE 1.4) in the acupuncture group, 35.8 (1.9) in the minimal acupuncture group, and 49.6 (2.0) in the waiting list group (treatment difference acupuncture vs minimal acupuncture -8.8, [95% CI -13.5 to -4.2], p=0.0002; acupuncture vs waiting list -22.7 [-27.5 to -17.9], p<0.0001). After 52 weeks the difference between the acupuncture and minimal acupuncture groups was no longer significant (p=0.08).\n After 8 weeks of treatment, pain and joint function are improved more with acupuncture than with minimal acupuncture or no acupuncture in patients with osteoarthritis of the knee. However, this benefit decreases over time.", "The purpose of this study was to determine whether acupuncture was more effective than sham acupuncture in the reduction of pain in persons with osteoarthritis (OA) of the knee.\n Forty subjects (20 men, 20 women) with radiographic evidence of OA of the knee were stratified by gender and randomly assigned to either the experimental (real acupuncture) or control (sham acupuncture) groups. Subjects were treated three times per week for 3 weeks and evaluated at three test sessions. Outcome measures were: 1) the Pain Rating Index of the McGill Pain Questionnaire, 2) the Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Index, and 3) pain threshold at four sites at the knee.\n The analyses of variance showed that both real and sham acupuncture significantly reduced pain, stiffness, and physical disability in the OA knee, but that there were no significant differences between groups.\n Acupuncture is not more effective than sham acupuncture in the treatment of OA pain." ]

[ "1562888", "9855212", "15695959", "14962967" ]

[ "[Adhesive capsulitis of the shoulder: a comparative study of arthrography with intra-articular corticotherapy and with or without capsular distension].", "Treatment of \"frozen shoulder\" with distension and glucorticoid compared with glucorticoid alone. A randomised controlled trial.", "Arthrographic distension of the shoulder joint in the management of frozen shoulder.", "Arthrographic joint distension with saline and steroid improves function and reduces pain in patients with painful stiff shoulder: results of a randomised, double blind, placebo controlled trial." ]

[ "A double-blind, prospective study of 45 patients with adhesive capsulitis of the shoulder compared the therapeutic efficacy of distensive and nondistensive arthrography in combination with the intra-articular injection of corticosteroids. After 1 and 3 months there was no significant difference between the two treatments in the degree of pain or of limitation of movement experienced by the patients. More than 80% of the patients who experienced pain at rest and nocturnal pain improved under both treatment regimens. Scapulohumeral mobility increased significantly but only partially within the first month of treatment. Articular capacity and the duration of symptoms before treatment were of no prognostic value.", "This study is a comparison of treatments of idiopathic \"Frozen Shoulder\" (adhesive capsulitis), distension combined with steroid is compared with steroid alone. Evaluation was based on pain scales, analgesic usage, and range of motion outcome scales. Out of one-hundred twenty patients (age, mean 51, range 21-70) that were referred under the diagnosis FS, twenty-six fulfilled the criteria for inclusion in the study, but four patients did not want to participate in the trial, giving a total of 22 patients (age, mean 53, range 40-65) in the study. Patients were randomised by the envelope method. Two patients dropped-out, one in each treatment group thus leaving the study with 20 patients for the final statistical analysis. Eight were treated with steroid alone and 12 with distension combined with steroid. Patients received one treatment per week for a six weeks period with a follow-up at 12 weeks. They were evaluated by pain VAS on function and at rest within the study period, the different ranges of motion (ROM) were measured at inclusion time and subsequent afterwards at 3, 6, and 12 weeks. The VAS outcomes showed no difference between the treatments (VAS-function p=0,1; VAS-rest p=0.1), while in the distension group ROM showed significant improvement in all directions except extension (external p=0.0007, flexion p=0.03, extension p=0,01). The analgesic usage was significantly lower in the group treated with distension at the end of the study (p=0.008). A blinded clinical assessment of ROM also showed significant improvement (p=0.002). It is concluded that distension with steroid can seem to help in management of \"Frozen Shoulder\". Other studies seems to support the conclusion.", "The study was an open randomized controlled trial to compare the outcome at 8 weeks with two different modalities in the treatment of 'Frozen shoulder'. Clinical cases with painful limitation of movement of shoulder were randomized to receive physical therapies alone versus physical therapies and shoulder arthrography with intra-articular steroid in a sequential randomization process. Cases suspected of having a concomitant illness and has potential to cause secondary frozen shoulder were excluded, such as, history of trauma to shoulder over the last 6 months, symptomatic clinical cervical degenerative diseases, and causes in and around the shoulder (infective and non-infective). Physical Therapies provided to all patients were therapeutic exercises, transcutaneous electrical nerve stimulation (TENS) and infra-red radiation (IRR). Outcome measures were improvement of pain on a Visual Analogue Scale (VAS) score and range of motion measured by Goniometer at 8 weeks. Patients were followed weekly for 8 weeks and outcome parameters were recorded on every evaluation. The baseline range of motion in the two groups was comparable. At 8 weeks a statistically significant difference in outcome were observed in the two groups. The chi-square means difference of improvement in range of motion for abduction was p <0.00 and for external rotation was p <0. 00. The pain reduction on VAS score was not significant in the two groups (p <0. 40). In the present small series, the distension arthrography with intra-articular (IA) steroid plus physical therapy was superior over physical therapy alone in the functional improvement of the frozen shoulder. Further studies with larger sample size are required to confirm the observations.", "To determine whether arthrographic distension with a mixture of saline and steroid, in patients with painful stiff shoulder for at least 3 months, is better than placebo in improving function, pain, and range of motion at 3, 6, and 12 weeks.\n A randomised, placebo controlled trial with participant and outcome assessor blinding in which shoulder joint distension with normal saline and corticosteroid was compared with placebo (arthrogram). Outcome measures, assessed at 3, 6, and 12 weeks, included a shoulder-specific disability measure (SPADI), a patient preference measure (Problem Elicitation Technique (PET)), pain, and range of active motion.\n From 96 potential participants, 48 were recruited. Four withdrew from the placebo group after the 3 week assessment and three subsequently received arthrographic distension with saline and steroid. At 3 weeks, significantly greater improvement in SPADI (p = 0.005), PET, overall pain, active total shoulder abduction, and hand behind back was found in participants in the joint distension and steroid group than in the placebo group. At 6 weeks the results of the intention to treat analysis favoured joint distension, although the between-group differences were only significant for improvement in PET (difference in mean change in PET between groups = 45.9 (95% CI 3.2 to 88.7). Excluding the four withdrawals, the between-group differences for the disability and pain measures significantly favoured distension over placebo. At 12 weeks, both the intention to treat analysis and an analysis excluding the four withdrawals demonstrated a significantly greater improvement in PET score for the distension group.\n Short term efficacy of arthrographic distension with normal saline and corticosteroid over placebo was demonstrated in patients with painful stiff shoulder." ]

[ "19875173" ]

[ "A randomized controlled trial comparing everting sutures with everting sutures and a lateral tarsal strip for involutional entropion." ]

[ "To determine whether there is a statistically significant difference in the surgical outcome of everting sutures (ES) alone versus everting sutures with a lateral tarsal strip (ES+LTS) in the treatment of involutional entropion.\n Prospective randomized comparative trial.\n Sixty-three patients with primary involutional lower eyelid entropion were enrolled in the study. The age range was 54 to 94 years, with a mean age of 77 years. Baseline characteristics of the comparative groups were similar.\n Patients requiring primary surgical repair for involutional entropion were selected, and those providing informed consent were randomized for surgery. Thirty-six patients were randomized to ES alone, and 27 patients were randomized to ES+LTS. Patients were evaluated at 3 weeks and 6, 12, and 18 months postoperatively.\n Successful surgery was defined as a normal eyelid position at rest and inability to induce entropion on tetracaine provocation testing at or before the 18-month follow-up visit.\n Eight patients were lost to follow-up (7 had ES alone). Of the 55 patients with complete follow-up data, there were 6 failed procedures in the patients who underwent ES alone and no failed procedures in the patients who underwent ES+LTS (P = 0.02).\n These data provide strong evidence that success rates at 18 months are higher in patients treated with ES+LTS procedure compared with ES alone.\n Copyright (c) 2010 American Academy of Ophthalmology. Published by Elsevier Inc. All rights reserved." ]

[ "12728754", "9405902", "3698783", "20414559", "1827394", "2589581", "18758747", "1296898", "3297575" ]

[ "A randomized pilot study of improving foot care in home health patients with diabetes.", "Evaluation of the impact of podiatrist care in the primary prevention of foot problems in diabetic subjects.", "A randomized study of the effects of a home diabetes education program.", "[Evaluation of a neuropathic ulcers prevention program for patients with diabetes].", "Intensive education improves knowledge, compliance, and foot problems in type 2 diabetes.", "Prevention of amputation by diabetic education.", "Education for secondary prevention of foot ulcers in people with diabetes: a randomised controlled trial.", "Foot care: knowledge retention and self-care practices.", "Randomized, controlled trial of diabetic patient education: improved knowledge without improved metabolic status." ]

[ "The purpose of this study was to test the effectiveness of an educational intervention to improve patients' foot care knowledge, self-efficacy, and self-care practices.\n A prospective, randomized, single center, 2-group design was used with a convenience sample of 40 home care patients from a Medicare-certified home health agency. Baseline measures of foot care knowledge, self-efficacy, and reported self-care practices were obtained at study entry and 6 weeks later to control for foot care interventions provided during routine home care services. After obtaining the 6-week baseline measures, patients who were randomized to the intervention group received individualized education about proper foot care. All patients were interviewed a third time 3 months after study entry to determine the effectiveness of the intervention.\n The educational intervention improved patients' knowledge, confidence, and reported foot care behaviors.\n A brief, individualized educational intervention about standard foot care topics improved patients' foot care knowledge and self-efficacy as well as reported self-care practices. Incorporating such interventions into routine home care services may enhance the quality of care and decrease the incidence of lower-extremity complications.", "To evaluate the influence of podiatrist activities on the outpatient care of diabetic patients in terms of knowledge of diabetic foot care, self-care, and minor foot problems.\n There were 733 patients, aged 10-79 years, identified from the national diabetes register. Patients without recent visits to a podiatrist and without an obvious need for foot care were randomized into a podiatric care group (education and primary prevention measures, n = 267) and a control group (written instructions only, n = 263). The patients were examined by an independent study podiatrist at baseline and after 1 year.\n Patients in the podiatrist group had greater improvement in knowledge of diabetic foot care (P = 0.004) and self-care (P < 0.001) scores compared with control subjects. The prevalence of callosities in regions other than the calcaneal region decreased more (P = 0.009) in the podiatrist group (from 54.5 to 39.5%) than in the control group (from 51.3 to 48.2%), and the size of the callosities decreased more (P < 0.001) in the podiatrist group than in the control group. Reduction in the prevalence of callosities was associated with younger age (< 50 years).\n Education and primary preventive measures provided individually by a podiatrist result in significant improvements in knowledge and foot self-care scores and in improvements in the prevalence of some minor foot problems. Long-term studies are needed to evaluate whether the intervention of podiatrists starting at an early phase would lead to a reduction in major foot problems.", "Home health nurses provided individualized instruction in diabetes self-care within the home environment of 393 diabetic individuals. Each subject was randomly assigned to either the intervention (those receiving home teaching) or control (those not receiving home teaching) group. At 6 mo postenrollment, intervention subjects showed significantly greater self-care knowledge and skills than control subjects, although the actual differences between the two groups in terms of self-care skills were probably too small to have any practical meaning. The primary objective of the study, which was the reduction of the number of preventable diabetes-related hospitalizations (ketoacidosis, ketotic coma, nonketotic coma, insulin reaction, and diabetes out of control), was not achieved; no differences between the groups were noted after 12 mo of follow-up. Similarly, length of hospital stay, foot problems, emergency room and physician visits, and sick days were roughly equivalent in both groups during the follow-up year. These results suggest that, in the absence of concurrent changes in the health-care delivery system and strategies for influencing attitudes toward self-care, education alone is ineffective.", "Neuropathic foot ulcers are among the major health problems faced by patients with diabetes mellitus.\n To evaluate the preventive efficacy of a therapeutic education and protective footwear program in the incidence and recurrence of neuropathic ulcers due to diabetes.\n Fifty-three patients with diabetes and neuropathy from a public healthcare unit in Porto Alegre, Rio Grande do Sul, took part in a clinical trial for two years. The participants were randomly allocated to an intervention group (n=30) or a control group (n=23). Therapeutic education was provided in group sessions, and protective footwear was supplied in accordance with individual prescriptions. The nonparametric Mann-Whitney test was used to determine differences in incidence and recurrence of ulceration between the groups. Life-table analysis and the Kaplan-Meier method were used to measure the duration of ulcer-free survival.\n In the intervention group, the ulcer incidence rate was 38.1% compared to 51.1% in the control group. Among the participants who presented ulcers, 83% were in the control group and 16.7% in the intervention group. After one year, the participants in the intervention group had a 75% chance of being ulcer-free, compared with 61% in the control group, and these percentages reduced to 60% and 52% respectively after two years. There was a tendency toward shorter survival among the control group participants.\n Although the proposed program lowered recurrence rates and increased the duration of ulcer-free survival, it was unable to prevent occurrence and recurrence of neuropathic ulcers due to diabetes.", "Despite the established role of foot care education in diabetes management, reports evaluating such interventions are rare. The effectiveness of an intensive foot care intervention programme and a conventional one were therefore compared in Type 2 diabetes. The intensive group showed significantly greater improvements than the conventional group in foot care knowledge (p less than 0.001), compliance with the recommended foot care routine (p = 0.012), and compliance with the initial advice to consult a podiatrist (other than the project podiatrist) for further treatment (p = 0.008). At the first follow-up visit the intensive group also showed a significantly greater reduction in the number of foot problems requiring treatment than the conventional group.", "This prospective randomized study evaluated the influence of a simple education program on the incidence of lower extremity amputation in diabetic patients. Two hundred three patients were randomized into two groups: Group 1, education (103 patients, 203 limbs) and Group 2, no education (100 patients, 193 limbs). There were no significant differences in medical management or clinical risk factors between the two groups. The amputation rate was three times higher in Group 2 (21 of 177 limbs versus 7 of 177 limbs; p less than or equal to 0.025), the ulceration rate was three times higher in Group 2 (26 of 177 limbs versus 8 of 177 limbs; p less than or equal to 0.005), and there was no difference in the overall incidence of infection (2 of 177 limbs). Overall success in Group 1 was highly significantly different from Group 2 (160 of 177 limbs versus 128 of 177 limbs; p less than or equal to 0.0005). This study demonstrated that a simple education program significantly reduced the incidence of ulcer or foot and limb amputation in diabetic patients.", "This observer-blind, randomised controlled trial was designed to determine the effect of a foot care education programme in the secondary prevention of foot ulcers.\n People with newly healed foot ulcers attending one of three specialist clinics were allocated to receive either targeted, one-to-one education or usual care, using a computer-generated random allocation sequence that had been prepared in advance but which was concealed from the clinical researcher. The primary outcome was ulcer incidence at 12 months. Secondary outcomes were ulcer incidence at 6 months and incidence of amputation, mood (Hospital Anxiety and Depression Scale) and quality of life (Diabetic Foot Ulcer Scale) at 6 and 12 months. Protective foot care behaviours (Nottingham Assessment of Functional Footcare) were assessed at 12 months.\n There were 87 (mean [SD] age 63.5 [12.1] years) patients in the intervention group and 85 control patients (mean [SD] age 64.9 [10.9] years). The groups were comparable at baseline. No significant differences (p > 0.05) were observed between groups in ulcer incidence at either 6 months (intervention 30%, control 21%) or 12 months (intervention 41%, control 41%). Recommended foot care behaviours at 12 months were better in the intervention than in the control group (p = 0.03), but education had no significant (p > 0.05) effect on mood, quality of life or amputations.\n Even though the intervention was associated with improved foot care behaviour, there was no evidence that this programme of targeted education was associated with clinical benefit in this population when compared with usual care. The usefulness and optimal delivery of education to such a high-risk group requires further evaluation.\n ClinicalTrials.gov NCT00729456 Funding: Diabetes UK project grant RD02/0002535.", "This study investigated the effectiveness of a \"hands-on\" foot care teaching/learning approach for adults with diabetes. By random assignment, the control group received a lecture presentation on foot care, while the experimental group participated in a hands-on session on foot care in addition to the lecture presentation. Data concerning the subjects' foot care knowledge and skills, the condition of their feet, and their level of HbA1c were gathered prior to and six months after the foot care educational sessions. No significant increases in knowledge about foot care were observed in the experimental group. The experimental group reported improvements in inspecting and washing their feet on a daily basis, and in care of the toenails. No significant differences were observed in the status of the subjects' feet. The HbA1c readings were significantly improved for both the experimental (t = 4.10, df = 10, p = 0.002) and control (t = 2.25, df = 9, p = 0.051) groups. A hands-on educational session may improve foot care practices temporarily. However, long term effects need to be studied to discern overall improvement of foot care practices and physical status of the feet.", "We randomized 749 insulin-treated patients on the rolls of the Mount Sinai Medical Center Diabetes Clinic in a controlled trial of diabetic patient education; 345 agreed to participate, of whom 165 were assigned to the education group and 180 to the control group. Cognitive scores increased from 5.3 +/- 1.6 to 5.8 +/- 1.6 in the education group, but there was no change in the control group, whose score was 5.3 +/- 1.7 before and after the intervention (P = .0073). HbA1c fell from 6.8 +/- 2.1 to 6.1 +/- 2.0% in the education group and from 6.6 +/- 2.0 to 6.3 +/- 2.0% in the control group, an insignificant difference (P = .1995). The fasting blood glucose decreased from 223 +/- 94 to 179 +/- 73 mg/dl in the education group and from 199 +/- 81 to 185 +/- 76 mg/dl in the controls (P = .1983). Triglycerides, high- and low-density lipoprotein cholesterol, and insulin dosage also failed to show significant variation among groups. The foot-lesion score showed similar progression in the education and control groups. Neither diastolic nor systolic blood pressure showed significantly greater change in the education or the control group, with falls noted, particularly in diastolic pressures, in both patient groups. Differences between the groups were not significant for sick days, hospitalizations, emergency room visits, or outpatient visits. The sample sizes of the study and control populations were sufficiently large to detect a difference in means between the education and control groups in the HbA1c, the primary outcome variable, of greater than 1.0%, with alpha = .05 and a power of .95. Thus, our study suggests that patient education may not be an efficacious therapeutic intervention in most adults with insulin-treated diabetes mellitus." ]

[ "11897647", "10733441", "11985913", "1709338", "12548091", "12821234", "8053614", "2107780" ]

[ "Continuous subcutaneous infusion of treprostinil, a prostacyclin analogue, in patients with pulmonary arterial hypertension: a double-blind, randomized, placebo-controlled trial.", "Continuous intravenous epoprostenol for pulmonary hypertension due to the scleroderma spectrum of disease. A randomized, controlled trial.", "Effects of beraprost sodium, an oral prostacyclin analogue, in patients with pulmonary arterial hypertension: a randomized, double-blind, placebo-controlled trial.", "Failure of vasoldilator infusion to alter pulmonary diffusing capacity in systemic sclerosis.", "Efficacy and safety of treprostinil: an epoprostenol analog for primary pulmonary hypertension.", "Beraprost therapy for pulmonary arterial hypertension.", "Survival in primary pulmonary hypertension with long-term continuous intravenous prostacyclin.", "Treatment of primary pulmonary hypertension with continuous intravenous prostacyclin (epoprostenol). Results of a randomized trial." ]

[ "Pulmonary arterial hypertension is a life-threatening disease for which continuous intravenous prostacyclin has proven to be effective. However, this treatment requires a permanent central venous catheter with the associated risk of serious complications such as sepsis, thromboembolism, or syncope. Treprostinil, a stable prostacyclin analogue, can be administered by a continuous subcutaneous infusion, avoiding these risks. We conducted a 12-week, double-blind, placebo-controlled multicenter trial in 470 patients with pulmonary arterial hypertension, either primary or associated with connective tissue disease or congenital systemic-to-pulmonary shunts. Exercise capacity improved with treprostinil and was unchanged with placebo; the between treatment group difference in median six-minute walking distance was 16 m (p = 0.006). Improvement in exercise capacity was greater in the sicker patients and was dose-related, but independent of disease etiology. Concomitantly, treprostinil significantly improved indices of dyspnea, signs and symptoms of pulmonary hypertension, and hemodynamics. The most common side effect attributed to treprostinil was infusion site pain (85%) leading to premature discontinuation from the study in 8% of patients. Three patients in the treprostinil treatment group presented with an episode of gastrointestinal hemorrhage. We conclude that chronic subcutaneous infusion of treprostinil is an effective treatment with an acceptable safety profile in patients with pulmonary arterial hypertension.", "Pulmonary hypertension is a progressive and often fatal complication of the scleroderma spectrum of disease for which no treatment has been proven effective in a randomized trial.\n To determine the effect of epoprostenol on pulmonary hypertension secondary to the scleroderma spectrum of disease.\n Randomized, open-label, controlled trial.\n 17 pulmonary hypertension referral centers.\n 111 patients with moderate to severe pulmonary hypertension.\n Epoprostenol plus conventional therapy or conventional therapy alone.\n The primary outcome measure was exercise capacity. Other measures were cardiopulmonary hemodynamics, signs and symptoms of pulmonary hypertension and scleroderma, and survival.\n Exercise capacity improved with epoprostenol (median distance walked in 6 minutes, 316 m at 12 weeks compared with 270 m at baseline) but decreased with conventional therapy (192 m at 12 weeks compared with 240 m at baseline). The difference between treatment groups in the median distance walked at week 12 was 108 m (95% CI, 55.2 m to 180.0 m) (P < 0.001). Hemodynamics improved at 12 weeks with epoprostenol. The changes in mean pulmonary artery pressure for the epoprostenol and conventional therapy groups were -5.0 and 0.9 mm Hg, respectively (difference, -6.0 mm Hg [CI, -9.0 to -3.0 mm Hg), and the mean changes in pulmonary vascular resistance were -4.6 and 0.9 mm Hg/L per minute, respectively (difference, -5.5 mm Hg/L per minute [CI, -7.3 to -3.7 mm Hg/L per minute). Twenty-one patients treated with epoprostenol and no patients receiving conventional therapy showed improved New York Heart Association functional class. Borg Dyspnea Scores and Dyspnea-Fatigue Ratings improved in the epoprostenol group. Trends toward greater improvement in severity of the Raynaud phenomenon and fewer new digital ulcers were seen in the epoprostenol group. Four patients in the epoprostenol group and five in the conventional therapy group died (P value not significant). Side effects of epoprostenol therapy included jaw pain, nausea, and anorexia. Adverse events related to the epoprostenol delivery system included sepsis, cellulitis, hemorrhage, and pneumothorax (4% incidence for each condition).\n Continuous epoprostenol therapy improves exercise capacity and cardiopulmonary hemodynamics in patients with pulmonary hypertension due to the scleroderma spectrum of disease.", "The purpose of this study was to assess the efficacy and safety of beraprost sodium, an orally active prostacyclin analogue, in New York Heart Association (NYHA) functional class II and III patients with pulmonary arterial hypertension (PAH).\n Pulmonary arterial hypertension is a life-threatening disease for which continuous intravenous infusion of prostacyclin has been proven effective. However, this treatment is associated with serious complications arising from the complex delivery system.\n In this double-blind, placebo-controlled study, 130 patients with PAH were randomized to the maximal tolerated dose of beraprost (median dose 80 microg four times a day) or to placebo for 12 weeks. The primary end point was the change in exercise capacity assessed by the 6-min walk test. Secondary end points included changes in Borg dyspnea index, cardiopulmonary hemodynamics and NYHA functional class.\n Patients treated with beraprost improved exercise capacity and symptoms. The difference between treatment groups in the mean change of 6-min walking distance at week 12 was 25.1 m (95% confidence interval [CI]: 1.8 to 48.3, p = 0.036). The difference in the mean change of Borg dyspnea index was -0.94 (95% CI: -1.63 to -0.24, p = 0.009). In the sub-group of patients with primary pulmonary hypertension, the difference in the mean change of 6-min walking distance was 46.1 m (95% CI: 3.0 to 89.3, p = 0.035). Cardiopulmonary hemodynamics and NYHA functional class had no statistically significant changes. Drug-related adverse events were common in the titration phase and decreased in the maintenance period.\n Beraprost improves exercise capacity and symptoms in NYHA functional class II and III patients with PAH and, in particular, in those with primary pulmonary hypertension.", "Patients with systemic sclerosis (SSc) do not exhibit a normal increase in the diffusing capacity for carbon monoxide (DLCO) on assuming the supine position. We sought to determine whether a potent prostacyclin derivative and vasodilator, iloprost, would reverse this defect.\n Fourteen patients with SSc were enrolled in a randomized, double-blind, placebo-controlled study of iloprost. Patients were tested before and during 3 days of iloprost or placebo infusion with both upright and supine pulmonary function studies.\n The results of baseline pulmonary function studies including DLCO were not significantly altered by iloprost. Furthermore, iloprost did not alter the abnormal postural DLCO response.\n These results suggest that the pulmonary vascular defects seen in this group of patients are not a consequence of reversible pulmonary vasospasm.", "Intravenous epoprostenol is currently FDA approved for management of primary pulmonary hypertension, but it requires intravenous infusion and is associated with adverse effects. The objective of this study was to evaluate the effects of an epoprostenol analog, treprostinil, for management of pulmonary hypertension. Ten tertiary care academic institutions with pulmonary hypertension programs participated in these pilot trials. In the first trial, intravenous epoprostenol and intravenous treprostinil were compared. In the second trial, intravenous treprostinil and subcutaneous treprostinil were compared. In the third trial, subcutaneous treprostinil was compared with placebo infusion during an 8-week period. Intravenous epoprostenol and intravenous treprostinil resulted in a similar reduction in pulmonary vascular resistance acutely (22% and 20%, respectively). Intravenous treprostinil and subcutaneous treprostinil also demonstrated comparable short-term decrease in pulmonary vascular resistance (23% and 28%, respectively). The placebo-controlled 8-week trial demonstrated a mean improvement of 37 +/- 17 m as measured by the 6-minute walk distance in patients receiving treprostinil compared with a 6 +/- 28 m reduction in those receiving placebo. There were trends toward an improvement in cardiac index and pulmonary vascular resistance index in the treprostinil group. Subcutaneous treprostinil has favorable hemodynamic effects when given acutely and in the short term. Treprostinil can be given safely to an ambulatory patient with a novel subcutaneous delivery pump system.", "The purpose of this study was to assess the safety and efficacy of the oral prostacyclin analogue beraprost sodium during a 12-month double-blind, randomized, placebo-controlled trial in patients with pulmonary arterial hypertension (PAH).\n Pulmonary arterial hypertension is a progressive disease that ultimately causes right heart failure and death. Despite the risks from its delivery system, continuous intravenous epoprostenol remains the most efficacious treatment currently available.\n A total of 116 patients with World Health Organization (WHO) functional class II or III primary pulmonary hypertension or PAH related to either collagen vascular diseases or congenital systemic to pulmonary shunts were enrolled. Patients were randomized to receive the maximal tolerated dose of beraprost sodium (median dose 120 microg four times a day) or placebo for 12 months. The primary end point was disease progression; i.e., death, transplantation, epoprostenol rescue, or >25% decrease in peak oxygen consumption (VO(2)). Secondary end points included exercise capacity assessed by 6-min walk test and peak VO(2), Borg dyspnea score, hemodynamics, symptoms of PAH, and quality of life.\n Patients treated with beraprost exhibited less evidence of disease progression at six months (p = 0.002), but this effect was not evident at either shorter or longer follow-up intervals. Similarly, beraprost-treated patients had improved 6-min walk distance at 3 months by 22 m from baseline and at 6 months by 31 m (p = 0.010 and 0.016, respectively) compared with placebo, but not at either 9 or 12 months. Drug-related adverse events were common and were related to the disease and/or expected prostacyclin adverse events.\n These data suggest that beneficial effects may occur during early phases of treatment with beraprost in WHO functional class II or III patients but that this effect attenuates with time.", "To evaluate the effects of long-term-intravenous infusion of prostacyclin on exercise capacity, hemodynamics, and survival in patients with primary pulmonary hypertension.\n Open, multicenter, uncontrolled trial.\n Four referral centers.\n 18 patients with primary pulmonary hypertension: 1 New York Heart Association (NYHA) class II patient, 13 NYHA class III patients, and 4 NYHA class IV patients.\n Continuous intravenous prostacyclin administered by portable infusion pumps. All patients were treated with anticoagulant agents.\n With the 6-minute walk used to evaluate exercise capacity, patients could walk on average more than 100 meters farther after prostacyclin therapy was initiated (distance at 6 months, 370 +/- 119 meters compared with 264 +/- 160 meters at baseline; P < 0.001; distance at 18 months, 408 +/- 138 meters; P = 0.02 compared with baseline). Hemodynamics were improved at 6 months: The cardiac index increased 18% (95% CI, 0.1% to 36.7%; P = 0.02), and mean pulmonary artery pressure and total pulmonary resistance decreased 9% (CI, 1.4% to 15.7%; P = 0.03) and 26% (CI, 6.1% to 46.3%; P = 0.02), respectively, compared with baseline. The improvements in cardiac index and total pulmonary resistance were maintained at 12 months (27% increase [CI, 1.3% to 51.9%; P = 0.05] and 32% decrease [CI, 9.7% to 53.6%; P = 0.02] compared with baseline, respectively). Survival was improved in NYHA class III and IV patients who received continuous prostacyclin (n = 17; follow-up, 37 to 69 months) when compared with historical controls who received standard therapy (National Institutes of Health Primary Pulmonary Hypertension Registry, n = 31, P = 0.045). Kaplan-Meier estimates of 1-, 2-, and 3-year survival rates for the patients treated with prostacyclin were 86.9%, 72.4%, and 63.3%, respectively, compared with 77.4%, 51.6%, and 40.6% for the historical control group (hazard ratio, 2.9 [CI, 1.0 to 8.0; P = 0.045]). Serious complications attributable to the drug and delivery system included two deaths and seven episodes of nonfatal sepsis in three patients.\n Continuous intravenous prostacyclin resulted in sustained clinical and hemodynamic improvement and probably in improved survival in patients with severe primary pulmonary hypertension. Despite potentially serious complications, long-term prostacyclin may be especially helpful in seriously ill patients awaiting transplantation.", "To determine the efficacy of continuous intravenous infusion of prostacyclin (epoprostenol) in primary pulmonary hypertension.\n Randomized trial with 8-week treatment periods and nonrandomized treatment for up to 18 months.\n Four referral centers.\n Sequential sample of 24 patients with primary pulmonary hypertension. Nineteen patients completed the study. Four patients died and one left the study because of adverse effects (pulmonary edema).\n Continuous intravenous prostacyclin administered by portable infusion pump at doses determined by acute responses during baseline catheterization in ten patients. Nine patients were treated with anticoagulants, oral vasodilators, and diuretics.\n Starting with a baseline value for total pulmonary resistance of 21.6 units, there was a decrease of 7.9 units (95% CI, -13.1 to -2.2; P = 0.022) in the prostacyclin-treated group after 8 weeks; there was virtually no change in the conventional therapy group (from 20.6 to 20.4 units, not significant). Six of ten prostacyclin-treated patients who completed the 8-week study period had reductions in mean pulmonary artery pressure of greater than 10 mm Hg, whereas only one of nine in the conventional treatment group had a similar response (P = 0.057). Nine patients receiving prostacyclin for up to 18 months have persistent hemodynamic effects, although dose requirements have increased with time. Complications have been attributable to the drug delivery system.\n Prostacyclin produces substantial and sustained hemodynamic and symptomatic responses in severe primary pulmonary hypertension and may be useful in the management of some patients with this disease." ]

[ "6805497", "2196496", "17466301", "8645639", "7688253", "2900977", "6145038", "10609721", "1974940", "16411994", "8355740" ]

[ "Predictive value of ultrasound measurement in early pregnancy: a randomized controlled trial.", "A randomized trial of routine prenatal ultrasound.", "Routine second-trimester ultrasound for low risk pregnancies in a South African community.", "Routine obstetric ultrasound examinations in South Africa: cost and effect on perinatal outcome--a prospective randomised controlled trial.", "Routine ultrasonography in utero and subsequent handedness and neurological development.", "Effects of routine one-stage ultrasound screening in pregnancy: a randomised controlled trial.", "Ultrasound screening in pregnancy: a randomised controlled trial.", "Is an ultrasound assessment of gestational age at the first antenatal visit of value? A randomised clinical trial.", "Ultrasound screening and perinatal mortality: controlled trial of systematic one-stage screening in pregnancy. The Helsinki Ultrasound Trial.", "Does a first trimester dating scan using crown rump length measurement reduce the rate of induction of labour for prolonged pregnancy? An uncompleted randomised controlled trial of 463 women.", "Effect of prenatal ultrasound screening on perinatal outcome. RADIUS Study Group." ]

[ "Early fetal biparietal diameter (BPD) measurements were obtained with ultrasound in 1062 women attending for antenatal care; a random half had the results withheld from the obstetricians. Of the 1026 women who were sure of the dates of their last normal menstrual period, 829 (81%) were found to have appropriate biparietal diameter measurements, in 3% the pregnancy was more than 2 weeks further advanced and in 14% more than 2 weeks less than calculated. In 30% of the women whose results were intended to be withheld, the code had to be broken because of clinical concern. There were no differences in fetal outcome (birthweight centile, Apgar score at 1 min and perinatal mortality) in the women whose BPD results were known compared with those whose results were withheld from the obstetrician. But a significantly larger number of labours were induced for suspected growth retardation when the gestational age was known.", "Nine hundred fifteen of 2171 pregnant patients had no indication for ultrasound at their first prenatal visit and were randomly assigned to receive either a single routine screening ultrasound or usual prenatal care. The estimated date of confinement was altered in 24.9% of routine-ultrasound patients and in 11.6% of usual-care patients through ultrasound examinations obtained for a subsequent clinical indication. Of these, 8.3% of routine-ultrasound and 5.2% of usual-care patients had gestational age errors of 2 weeks or more. There were no differences between the groups in inductions for post-dates pregnancy (7.0 versus 7.5%; P = .87), total inductions (22.6 versus 24.9%; P = .61), or adverse perinatal outcomes (6.7 versus 8.3%; P = .63). Both sets of twins were detected in the screened group. In the usual-care group, five of seven pairs of twins (71%) were diagnosed by 24 weeks' gestation. There was no benefit found from routine ultrasound as performed in this study.", "nan", "To compare routine midtrimester with selective obstetric ultrasonography concerning the Health Service cost and the effect on perinatal outcome.\n A randomised controlled trial.\n Urban area served by Tygerberg Hospital, a tertiary referral centre in South Africa.\n Pregnant patients without risk factors for congenital anomalies referred for ultrasonography between 18 and 24 weeks of gestation.\n Between 18 and 24 weeks, a level one ultrasound examination was performed on study patients only. Except for the routine scan, both groups received the same antenatal care and could be referred later for additional scans as judged by their clinicians.\n Overall adverse perinatal outcome and use of antenatal and neonatal services.\n The groups did not differ significantly in their use of antenatal and neonatal services except for a greater number of ultrasound scans in the study group. More suspected postdate pregnancies occurred in control patients, as well as more amniocenteses for confirmation of lung maturity. More babies of low birthweight were born in the study group. The incidence of overall or major adverse perinatal outcome was comparable. Routine ultrasonography was accompanied by a considerable increase in costs.\n Selective use of obstetric ultrasonography did not increase the use of antenatal and neonatal services. Not routinely performing ultrasonography has led to considerable Health Service savings without increasing the risk for adverse perinatal outcome. It saved 75% of selected patients a referral to an ultrasound unit. Specific problems related to inaccurate gestational age determination need to be addressed.", "To examine any associations between routine ultrasonography in utero and subsequent brain development as indicated by non-right handedness at primary school age and neurological development during childhood.\n Follow up of 8 and 9 year old children of women who took part in two randomised, controlled trials of routine ultrasonography during pregnancy.\n Clinics of 60 general practitioners in Norway during 1979-81. Maternal and child health centres.\n 2161 (89%) of 2428 eligible singletons were followed up, partly through a questionnaire to their parents and partly through information from health centres.\n The dominant hand of the child was assessed by 10 questions. Deficits in attention, motor control, and perception were evaluated by five questions. Impaired neurological development during the first year of life was assessed by an abbreviated version of the Denver developmental screening test.\n The odds of non-right handedness were higher among children who had been screened in utero than among control children (odds ratio 1.32; 95% confidence interval 1.02 to 1.71). No clear differences were found between the groups with regard to deficits in attention, motor control, and perception or neurological development during the first year of life.\n Our data suggest a possible association between routine ultrasonography in utero and subsequent non-right handedness, whereas no association with impaired neurological development was found. As the question on non-right handedness was one of six initial hypotheses, the observed results may be due to chance. None the less, the results suggest that the hypothesis may have some merit and should be tested in future studies.", "4997 of 7354 pregnant women had no clinical indication for an elective ultrasound examination at 12 weeks' gestation. 2482 of these women were randomly selected for ultrasound screening at 15 weeks and the remainder received the same standard antenatal care without the scan. Labour was less often induced among screened women both for all reasons (5.9% vs 9.1%, p less than 0.0001) and for suspected post-term pregnancy (1.7% vs 3.7%, p less than 0.0001). Earlier detection of twins had no effect on neonatal outcome. Among babies born to screened women, fewer were of birthweight less than 2500 g (59 vs 95, p = 0.005) and mean birthweight was 42 g higher (p 0.008). For babies born to screened women who smoked it was 75 g higher (p 0.012) and for those of non-smokers 26 g (not significant). The reason for the differences in mean birthweight could be that screened women reduced smoking in response to watching their fetus on the scan.", "nan", "To assess the efficacy of an ultrasound scan at the first antenatal visit.\n Randomised clinical trial.\n Women's and Children's tertiary level hospital, Adelaide, Australia.\n Six hundred and forty-eight women attending for their first antenatal visit at less than 17 weeks of gestation who had no previous ultrasound scan in the pregnancy, who were expected to give birth at the hospital, and for whom there was no indication for an ultrasound at their first visit.\n Eligible consenting women were enrolled by telephone randomisation into either the ultrasound at first visit group, who had an ultrasound at the time of their first antenatal visit, or the control group in whom no ultrasound assessment was done at their first antenatal visit. Both groups of women completed a questionnaire at the end of the first visit on their feelings towards the pregnancy and anxiety levels. Data were collected on details of any ultrasound assessments, including the 18 to 20 weeks morphology scan, and pregnancy outcome. All primary analyses were on an intention-to-treat basis.\n The number of women who needed adjustment in dates of 10 days or more on the basis of their 18 to 20 weeks ultrasound morphology scan, who were booked for their morphology scan at sub-optimal gestations, who had a repeat of their maternal serum screening test, or who felt worried about their pregnancy at the end of the first antenatal visit.\n Fewer women (9%) in the ultrasound at first visit group needed adjustment of their expected date of delivery as a result of the 18 to 20 week ultrasound, compared with 18% of women in the control group (RR 0.52, 95% CI 0.34-0.79; P = 0.002). The number of women who had the 18 to 20 week ultrasound assessment timed suboptimally was similar to that in the control group (16% vs. 21%), as was the number of women who had a repeat blood sample taken for maternal serum screening (6% vs. 6%). Fewer women in the ultrasound at first visit group reported feeling worried about their pregnancy (RR 0.80, 95% CI 0.65-0.99; P = 0.04) or not feeling relaxed about their pregnancy (RR 0.73, 95% CI 0.56-0.96; P = 0.02), compared with women in the control group.\n A routine ultrasound assessment for dating offered to women at the first antenatal visit provides more precise estimates of gestational age and reduces the need to adjust the estimate of the date of delivery in mid-gestation. Women who had an ultrasound at the first visit reported more positive feelings about their pregnancy, compared with women in the control group at that time.", "During a 19-month period, 95% of all pregnant women in the greater Helsinki area, Finland, entered a study to compare one-stage ultrasonography screening with selective screening according to antenatal hospital use, obstetric procedures, and fetal outcomes. Of 9310 women who entered the trial, 4691 were randomly allocated to ultrasound screening between the 16th and 20th gestational weeks and 4619 to follow-up only. Screened and control groups otherwise had the same antenatal care, which included ultrasonography according to usual practice. Screened women made fewer visits to the antenatal outpatient clinic than did women in the control group (2.3 vs 2.6). There were no differences in the number of labour inductions or mean birthweights in the two groups. Perinatal mortality was significantly lower in the screened than in the control group (4.6/1000 vs 9.0/1000); this 49.2% reduction was mainly due to improved early detection of major malformations which led to induced abortion. All twin pregnancies were detected before the 21st gestational week in the screening group compared with 76.3% in the control group; perinatal mortality in the small series of twins was 27.8/1000 vs 65.8/1000, respectively.", "To evaluate the effect of a first trimester ultrasound dating scan on the rate of induction of labour for prolonged pregnancy.\n Randomised controlled trial to include 400 women in each arm of the trial.\n Participating general practices and a district general teaching hospital.\n Women attending their general practitioner in the first trimester to confirm pregnancy, in whom a first trimester ultrasound scan was not indicated.\n Women randomised to the study group (scan group) underwent an ultrasound dating scan between 8 and 12 weeks, measuring crown-rump length. The estimated date of delivery (EDD) was changed if there was a discrepancy of more than 5 days from the gestation, calculated from the last menstrual period (LMP). For the remaining women (no-scan group), gestation was determined using the LMP.\n The rate of induction of labour for prolonged pregnancy.\n Due to circumstances beyond the researchers' control, recruitment was abandoned when 463 women had been enrolled. The EDD was adjusted in 13 (5.7%) women in the scan group and in 2 (0.9%) in the no-scan group. There was no difference in the rate of induction for prolonged pregnancy between the scan (19 [8.2%]) and the no-scan (17 [7.4%]) groups (relative risk 1.10; 95% CI 0.59-2.07).\n Acknowledging the reduced numbers recruited for study, it is concluded that there is no evidence that a first trimester ultrasound dating scan reduces the rate of induction of labour for prolonged pregnancy and may result in a more expensive healthcare strategy.", "Many clinicians advocate routine ultrasound screening during pregnancy to detect congenital anomalies, multiple-gestation pregnancies, fetal growth disorders, placental abnormalities, and errors in the estimation of gestational age. However, it is not known whether the detection of these conditions through screening leads to interventions that improve perinatal outcome.\n We conducted a randomized trial involving 15,151 pregnant women at low risk for perinatal problems to determine whether ultrasound screening decreased the frequency of adverse perinatal outcomes. The women randomly assigned to the ultrasound-screening group underwent one sonographic examination at 15 to 22 weeks of gestation and another at 31 to 35 weeks. The women in the control group underwent ultrasonography only for medical indications, as identified by their physicians. Adverse perinatal outcome was defined as fetal death, neonatal death, or neonatal morbidity such as intraventricular hemorrhage.\n The mean numbers of sonograms obtained per woman in the ultrasound-screening and control groups were 2.2 and 0.6, respectively. The rate of adverse perinatal outcome was 5.0 percent among the infants of the women in the ultrasound-screening group and 4.9 percent among the infants of the women in the control group (relative risk, 1.0; 95 percent confidence interval, 0.9 to 1.2; P = 0.85). The rates of preterm delivery and the distribution of birth weights were nearly identical in the two groups. The ultrasonographic detection of congenital anomalies had no effect on perinatal outcome. There were no significant differences between the groups in perinatal outcome in the subgroups of women with post-date pregnancies, multiple-gestation pregnancies, or infants who were small for gestational age.\n Screening ultrasonography did not improve perinatal outcome as compared with the selective use of ultrasonography on the basis of clinician judgment." ]

[ "19786668", "16409425" ]

[ "Randomized phase II/III trial assessing gemcitabine/ carboplatin and methotrexate/carboplatin/vinblastine in patients with advanced urothelial cancer \"unfit\" for cisplatin-based chemotherapy: phase II--results of EORTC study 30986.", "Randomised phase II trial of gemcitabine and paclitaxel second-line chemotherapy in patients with transitional cell carcinoma (AUO Trial AB 20/99)." ]

[ "There is no standard treatment for patients with advanced urothelial cancer who are ineligible (\"unfit\") for cisplatin-based chemotherapy (CHT). To compare the activity and safety of two CHT combinations in this patient group, a randomized phase II/III trial was conducted by the EORTC (European Organisation for Research and Treatment of Cancer). We report here the phase II results of the study.\n CHT-naïve patients with measurable disease and impaired renal function (30 mL/min < glomerular filtration rate [GFR] < 60 mL/min) and/or performance status (PS) 2 were randomly assigned to receive either GC (gemcitabine 1,000 mg/m(2) on days 1 and 8 and carboplatin area under the serum concentration-time curve [AUC] 4.5) for 21 days or M-CAVI (methotrexate 30 mg/m(2) on days 1, 15, and 22; carboplatin AUC 4.5 on day 1; and vinblastine 3 mg/m(2) on days 1, 15, and 22) for 28 days. End points of response and severe acute toxicity (SAT) were evaluated with respect to treatment group, renal function, PS, and Bajorin risk groups.\n Three of 178 patients who were ineligible or did not start treatment were excluded. SAT was reported in 13.6% of patients on GC and in 23% on M-CAVI. Overall response rates were 42% (37 of 88) for GC and 30% (26 of 87) for M-CAVI. Patients with PS 2 and GFR less than 60 mL/min and patients in Bajorin risk group 2 showed a response rate of only 26% and 20% and an SAT rate of 26% and 25%, respectively.\n Both combinations are active in this group of unfit patients. However, patients with PS 2 and GFR less than 60 mL/min do not benefit from combination CHT. Alternative treatment modalities should be sought in this subgroup of poor-risk patients.", "The objectives are to evaluate and compare the response and toxicity of a 3-weekly and a 2-weekly regimen of gemcitabine (Gem) and paclitaxel (Pac) second-line treatment in patients with transitional cell carcinoma (TCC). Between June 2000 and July 2001, 30 patients with progressive disease (PD) during first-line chemotherapy (n = 11) or relapse after adjuvant cisplatin-based chemotherapy of a metastatic or locally advanced TCC (n = 18) have been randomised to receive either six cycles (schedule A) of 3-weekly Gem (1000 mg/qm, days 1 and 8) and Pac (175 mg/qm, day 1) or 2-weekly treatment until disease progression (schedule B) with Gem (1250 mg/qm, day 1) and Pac (120 mg/qm, day 2). Restaging was performed after every 6 weeks by clinical imaging. Of 30 patients, one patient in schedule A and two patients in schedule B were not evaluable for response due to serious adverse events (SAEs) during the first cycle. The overall objective response (OR) was 44% (12 of 27) with eight complete remissions (CRs) and four partial remissions. Median time to progression (TTP) was 11 (3-41) months in schedule A and 6 (1-15+) months in schedule B. Median survival was 13 (5-46) months in schedule A and 9 (0-16) months in schedule B. Schedule A showed a significantly higher rate of CRs (7 vs. 1, p < 0.05). With a median number of six (1-6) cycles (A) and nine (1-23) cycles (B), TTP and survival were not significantly different. In schedule B, one patient had WHO grade IV anaemia and leucopenia. WHO grade III toxicities were seen in schedule A/B as follows: anaemia 3 (23%)/2 (16%) patients, leucopenia 5 (38%)/2 (16%), thrombocytopenia 0/2 (16%) and alopecia 10 (76%)/4 (32%). The combination of Gem and Pac is an effective second-line regimen in patients with mainly poor prognosis due to PD after cisplatin-based chemotherapy. Except for three SAEs (uncertainly therapy related), both regimens were tolerated well. The 3-weekly schedule with a nonsplit Pac dose showed a significantly higher complete response rate in our small study population and, thus, might be superior to the 2-weekly schedule." ]

[ "17368248", "16036196", "9431882", "11704141", "18439502", "10856489", "1290441", "7646610", "9883403", "12660281", "19602758", "9091008", "10929961", "7843454", "10426243", "12468136", "10826574", "9236652", "11042297", "1420022" ]

[ "A randomized trial comparing local intracervical and combined local and paracervical anesthesia in outpatient hysteroscopy.", "Use of sublingual buprenorphine for pain relief in office hysteroscopy.", "Two modalities of topical anesthesia for office hysteroscopy.", "Use of diclofenac as an analgesic in outpatient hysteroscopy: a randomized, double-blind, placebo-controlled study.", "A randomized trial of outpatient hysteroscopy with and without intrauterine anesthesia.", "Stepwise pain score analysis of the effect of local lignocaine on outpatient hysteroscopy: a randomized, double-blind, placebo-controlled trial.", "Outpatient hysteroscopy: a comparison of 2 methods of local analgesia.", "Paracervical anesthesia for outpatient hysteroscopy.", "Paracervical anesthesia for hysteroscopy and endometrial biopsy in postmenopausal women. A randomized, double-blind, placebo-controlled study.", "Outpatient operative hysteroscopy with bipolar electrode: a prospective multicentre randomized study between local anaesthesia and conscious sedation.", "Comparison of efficacy of oral drotaverine plus mefenamic acid with paracervical block and with intravenous sedation for pain relief during hysteroscopy and endometrial biopsy.", "Topical anaesthesia for diagnostic hysteroscopy and endometrial biopsy in postmenopausal women: a randomised placebo-controlled double-blind study.", "Feasibility and pain control in outpatient hysteroscopy in postmenopausal women: a randomized trial.", "The use of topical anesthesia in diagnostic hysteroscopy and endometrial biopsy.", "Paracervical anaesthesia in outpatient hysteroscopy: a randomised double-blind placebo-controlled trial.", "Oral dexketoprofen for pain treatment during diagnostic hysteroscopy in postmenopausal women.", "A randomised double-blind placebo-controlled trial of transcervical intrauterine local anaesthesia in outpatient hysteroscopy.", "Randomised placebo controlled trial of mefenamic acid for premedication at outpatient hysteroscopy: a pilot study.", "Lidocaine spray and outpatient hysteroscopy: randomized placebo-controlled trial.", "Randomized placebo controlled trial to assess the role of intracervical lignocaine in outpatient hysteroscopy." ]

[ "To compare the amount of pain during and after hysteroscopy using local intracervical and combined local and paracervical anesthesia.\n Prospective randomized trial (Canadian Task Force classification I).\n University teaching hospital.\n Eighty-four women who underwent outpatient hysteroscopy for evaluation of the uterine cavity at McGill University Health Center.\n Randomization to local intracervical or combined local and paracervical anesthesia.\n Amount of pain experienced during the procedure and at 10, 30, and 60 minutes after the procedure was measured using a visual analog scale ranging from zero to 10 (zero = no pain; 10 = excruciating pain). The mean age of the patients in the local anesthesia group was 36.1 +/- 0.7 years and in the combined local and paracervical anesthesia group was 35.2 +/- 0.7 years. Patients experienced significantly more pain during than after the procedure. The mean pain scores in the local anesthesia group were significantly higher than in the combined anesthesia group during the procedure (3.2 +/- 0.3 vs 2.1 +/- 0.2; p <.01; 95% CI 0-2), 10 minutes after the procedure (1.9 +/- 0.2 vs 1.5 +/- 0.3; p = .03; 95% CI 0-1), and 30 minutes after the procedure (1.7 +/- 0.2 vs 1.0 +/- 0.2; p = .02; 95% CI 0-1). However, there was no significant difference in pain scores at 60 minutes after the procedure between the local anesthesia and combined anesthesia groups (0.9 +/- 0.2 and 0.7 +/- 0.1, respectively).\n Outpatient hysteroscopy with local or combined local and paracervical anesthesia was well tolerated by patients. However, combined anesthesia was associated with less pain during and at 10 and 30 minutes after the procedure. Most patients considered the pain as mild.", "To assess the efficacy of sublingual buprenorphine in the relief of pain associated with office hysteroscopy.\n Prospective, randomized study (Canadian Task Force classification I).\n Tertiary medical center.\n One hundred sixty-four women referred for office hysteroscopy from September 2003 through March 2004.\n Before hysteroscopy, 80 women received a tablet of buprenorphine (group A), and 84 women received a placebo (group B). Their pain sensations were evaluated on a 10-cm visual analog scale, and they were asked about the adverse reactions and level of satisfaction on the following day.\n The pain score in group A was 3.3 +/- 1.1, which was similar to 3.2 +/- 1.3 in group B. The pain scores in subgroups of women also were similar within the same group and between the two groups. Thirty-one women (38.8%) in group A reported adverse reactions, including nausea, vomiting, and drowsiness, while none in group B reported any adverse reactions.\n Office hysteroscopy with a 3.1-mm flexible hysteroscope is a well-tolerated procedure. Sublingual buprenorphine is not helpful in relieving the pain associated with hysteroscopy but is associated with significant adverse reactions.", "nan", "nan", "To evaluate the amount of pain during office hysteroscopy and endometrial biopsy with and without intrauterine anesthesia.\n Prospective randomized study (Canadian Task Force classification I).\n Academic teaching center.\n A total of 82 women underwent outpatient hysteroscopy for evaluation of their uterine cavity.\n Randomization to local cervical or combined cervical and intrauterine anesthesia.\n Amount of pain experienced during the procedure; 10, 30, and 60 minutes after the procedure; and during endometrial biopsy. We used a visual analog scale ranging from 0 to 10 (0: no pain, 10: excruciating pain). Of 82 patients, 4 patients were excluded, 36 patients underwent hysteroscopy using local cervical anesthesia, and 42 others with combined cervical and intrauterine anesthesia. The mean age of the patients in the local group was 37.4 +/- 0.8 years and in the combined group was 38.3 +/- 0.7 years. In both groups, patients experienced significantly more pain during and 10 minutes after the procedure than 30 and 60 minutes after. No significant differences occurred in the pain scores during the hysteroscopy, and 10, 30, and 60 minutes after between the 2 anesthesia groups. The pain score in the local group during endometrial biopsy was significantly higher than during (p <.05), 10 minutes after (p <.001), 30 minutes after (p <.001), and 60 minutes after (p <.001) the procedure, respectively. In the combined group, compared with the pain score during endometrial biopsy, the scores during the hysteroscopy (p <.05), 10 minutes after (p <.01), 30 minutes after (p <.001), and 60 minutes after (p <.001) the procedure were also less, respectively.\n Intrauterine anesthesia with medicated saline as a distending medium is ineffective. Endometrial biopsy is associated with more pain than hysteroscopy.", "OBJECTIVE: To assess the efficacy of lignocaine gel in reducing the overall pain and pain of individual steps during outpatient hysteroscopy in comparison with placebo (no anesthesia). DESIGN: A prospective, randomized, double-blind, placebo-controlled trial. SETTING: Outpatient hysteroscopy clinic in a regional hospital in Hong Kong. PATIENT(s): A total of 500 Chinese patients undergoing outpatient hysteroscopy. INTERVENTION(s): Application of lignocaine gel to the cervix during outpatient hysteroscopy. MAIN OUTCOME MEASURE(s): Mean pain score using present pain intensity, overall pain score measured by total area under the curve, and the pain score of individual steps in the procedure in patients receiving lignocaine gel were compared with those of patients having no anesthesia. The failure rate and poor-view rate in both groups were also compared. RESULT(s): There were no statistically significant differences in mean pain score, overall pain score, and pain score of individual steps between the lignocaine group and controls. The failure rate and poor-view rate also showed no statistically significant differences. CONCLUSION(s): Outpatient hysteroscopy without anesthesia is acceptable to most Chinese women, and the local application of lignocaine gel is not effective in reducing pain.", "A prospective, randomized study was undertaken to objectively compare pain tolerance of 2 methods of local analgesia for outpatient hysteroscopy. Patients in group 1 received a paracervical block using 20 ml of 1% lignocaine. Patients in group 2 received a uterosacral block using 2 ml of 2% lignocaine. There was no statistical difference between the 2 groups (p = < 0.65) in efficacy of pain relief. The method used for patients in group 2 reduces time and costs for outpatient hysteroscopy.", "One hundred seventy-seven women aged 41 +/- 8 (mean +/- SD) years, referred for evaluation of excessive uterine bleeding, were enrolled in an open-label randomized trial to evaluate the efficacy of local anesthesia before hysteroscopy in an outpatient population. The patients underwent hysteroscopy and endometrial biopsy with paracervical block by 10 mL of 1% mepivacaine hydrochloride solution (n = 87) or no local anesthesia (n = 90) and assessed lower abdominal and pelvic pain according to a 10-point linear analog scale. The mean +/- SD pain score was 4.5 +/- 2.0 at hysteroscopy and 5.2 +/- 2.1 at endometrial biopsy in the 87 subjects given a paracervical block versus 4.9 +/- 2.2 and 5.7 +/- 2.4 in the 90 women not given local anesthesia, without statistically significant differences. Paracervical anesthesia for routine outpatient hysteroscopy in premenopausal women may be superfluous.", "To evaluate the efficiency of paracervical anesthesia in reducing pain and the incidence of vasovagal reactions during diagnostic hysteroscopy with endometrial biopsy in postmenopausal women.\n A randomized, placebo-controlled, double-blind study. Seventy-two postmenopausal women underwent diagnostic hysteroscopy and endometrial biopsy. Hysteroscopies were performed by using a lens-based endoscope with a diameter of < 4 mm and endometrial biopsies by using a 3-mm Novak's curette. Ten milliliters of 1.5 mepivacaine or saline solution was injected at the junction of the cervix and vagina (at the 4 and 8 o'clock positions) by means of an appropriate needle before performing the intrauterine procedures. Referred pain was evaluated by means of a visual analogue scale; continuous monitoring of heart rate and blood pressure was also performed.\n Paracervical anesthesia significantly reduced pain at hysteroscopy and biopsy. The incidence of vasovagal reactions was also significantly lower in the anesthetized group.\n Paracervical anesthesia is effective for hysteroscopy and endometrial biopsy in postmenopausal women and may be indicated particularly for patients with cervical stenosis, for very anxious subjects and in all situations where pain stimulation could trigger threatening side effects due to systemic pathologies.", "The study was designed to compare local anaesthesia and conscious sedation for outpatient bipolar operative hysteroscopy in terms of pain control and patients' satisfaction.\n A prospective multicentre randomized study was carried out in university hospitals and in a private endoscopy unit. A total of 166 women with surgically treatable lesions associated with infertility or abnormal uterine bleeding was considered eligible for the study. Patients were randomized, using a computer-generated randomization list, into two groups. Group A (82 patients) underwent operative hysteroscopy with local anaesthesia. Group B (84 patients) received conscious sedation. Operative hysteroscopy was performed with a bipolar electrosurgical device to cut, vaporize and coagulate. Main outcome measures were pain control during the procedure, the post-operative pain score at 15 and 60 min, and at 24 h after the procedure, and patients' satisfaction rate.\n All procedures were completed within 35 min, the amount of saline used varied from 400-1200 ml. There were no significant differences between local anaesthesia and conscious sedation in terms of pain control during the procedure and in postoperative pain at different intervals. Satisfaction rate was similar in the two groups.\n Both local anaesthesia and conscious sedation can be used for operative hysteroscopy using a bipolar electrosurgical system without significant differences in terms of pain control and patients' satisfaction.", "Office hysteroscopy with endometrial biopsy is usually the first investigation for abnormal uterine bleeding and other uterine diseases.\n To evaluate the effect of oral drotaverine with mefenamic acid on pain perception during hysteroscopy and endometrial biopsy and to compare it with that of paracervical block using 1% lignocaine and with that of intravenous sedation using diazepam with pentazocine.\n Outpatient gynecological department and open randomized trial.\n One hundred twenty women undergoing hysteroscopy and endometrial biopsy were randomized into 3 groups. Group I received tablet containing drotaverine hydrochloride (80 mg)+mefenamic acid (250 mg), group II received lignocaine paracervically and group III received intravenous diazepam. The intensity of pain during the procedure, 30 and 60 minutes later on visual analog scale (VAS) was assessed.\n Statistical analysis was performed using Kruskal-Wallis test, with the Bonferroni correction, the t test, and the chi2 test.\n Groups were similar in age, parity, vaginal birth or relevant medical history. A statistically significant difference in pain scores was noted among the 3 groups during the procedure (group I, 4.13+/-1.28; group II, 5.93+/-1.26; group III, 5.58+/-1.51), (P<0.001); as well as 30 minutes later (group I, 1.78+/-0.89; group II, 2.53+/-0.81; group III, 2.23+/-0.94), (P<0.001) and 60 minutes later (group I, 1.2+/-0.46; group II, 1.98+/-0.83; group III, 1.68+/-0.75), (P<0.001). VAS at different time intervals among the groups was also statistically significant. No adverse effects were observed.\n Oral drotaverine with mefenamic acid is effective in women undergoing hysteroscopy and endometrial biopsy.", "To evaluate the efficacy and safety of topical anaesthesia in reducing pain and incidence of vasovagal reactions during diagnostic hysteroscopy with endometrial biopsy in postmenopausal women.\n Randomised placebo-controlled double-blind study.\n University hospital.\n Eighty postmenopausal women undergoing diagnostic hysteroscopy and endometrial biopsy.\n Two millilitres of 2% mepivacaine or saline solution were injected transcervically into the uterine cavity before performing the procedures.\n Evaluation of pain reduction on a visual analogue scale and continuous monitoring of heart rate and blood pressure.\n The use of the anaesthetic significantly reduced the pain experienced at hysteroscopy and endometrial biopsy. The occurrence of vasovagal reactions was significantly lower in the anaesthetised group.\n Topical anaesthesia attenuated pain and effectively prevented the occurrence of vasovagal reactions during hysteroscopy and endometrial biopsy in postmenopausal women.", "Three methods of diagnostic hysteroscopy have been tested for both women's compliance and feasibility of procedures in postmenopause.\n Three hundred and sixty-two postmenopausal women were enrolled in a three-arm study: 5 mm diagnostic sheath (Group 1, 119 women), 5 mm sheath with paracervical block (Group 2, 121 women), and 3.5 mm sheath (Group 3, 121 women). CO2 was the distention medium. Both feasibility of hysteroscopy (procedures failed due to stenosis or incomplete distention of cavity) and discomfort of women have been recorded. Pain perception has been measured on a visual numerical rating scale. Statistical analysis was performed by t-test for unpaired samples and chi-square test.\n Paracervical block was per se painful in 18.2% and bleeding from injection site occurred in 38.8%. Hysteroscopy failure due to stenosis occurred in 9%, 10% and 0.4% of the three groups respectively (p<0.01). Intolerable pain was reported by 17% of women in Group 1, 6% in Group 2 (p<0.05) and in none of Group 3 (p<0.01). Pain score improved from Group 1 to Group 3 (p<0.01). Hysteroscopy was incomplete because of gas leakage in 1.7% of both Group 1 and 2 and in 13.2% of Group 3 (p<0.01).\n Pain perception in postmenopausal women was reduced when paracervical block was used, but discomfort was even less with the narrow sheath hysteroscope. The narrow sheath will expose to a high percentage of inconclusive procedures but it can be overcome by changing to the large sheath hysteroscope without affecting patient pain perception.", "To show that intrauterine anesthesia is a reliable method for reducing pain associated with endocavitary procedures.\n A prospective, randomized, double-blind study.\n The Department of Obstetrics and Gynecology, Tor Vergata University of Rome, Rome, Italy.\n Forty-five patients undergoing diagnostic hysteroscopy (n = 27) or hysteroscopy and endometrial biopsy (n = 18).\n Five milliliters of 2% mepivacaine or saline solution were injected transcervically into the uterine cavity before performing the procedures.\n Evaluation of pain reduction on a visual analogue scale.\n Pain expectation and pain reported were reduced during and after the procedures.\n Topical anesthesia effectively reduces pain during hysteroscopy and endometrial biopsy.", "To evaluate the efficacy and safety of paracervical anaesthesia in reducing pain during outpatient hysteroscopy and endometrial biopsy.\n Prospective, randomised, placebo-controlled, double-blind study.\n One hundred women undergoing outpatient hysteroscopy and endometrial biopsy for abnormal uterine bleeding.\n Paracervical block using 10 mL of either 2% lignocaine or normal saline before the procedure.\n Evaluation of pain at different stages of hysteroscopy using a visual analogue scale together with blood pressure and heart rate monitoring.\n Compared with placebo, paracervical anaesthesia significantly reduced the pain only at the time of insertion of the hysteroscope, but not at the subsequent stages of the procedure. However, paracervical injection of lignocaine resulted in a higher incidence of bradycardia and hypotension.\n Paracervical anaesthesia not only fails to reduce pain during outpatient hysteroscopy and endometrial biopsy, but also carries a risk of inducing bradycardia and hypotension, which is probably a result of inadvertent intravascular injection.", "To assess the efficacy of dexketoprofen (DEX) in reducing pain at different stages of the hysteroscopic procedure in comparison with local anaesthesia in menopausal women.\n Menopausal patients affected by uterine bleeding submitted to diagnostic hysteroscopy, were randomised to receive either 25 mg DEX tablet (n = 148) or intracervical injection of 5 ml mepivacaine 2% (n = 150). Pain suffered during the procedure itself and 30, 60, 120 min after, was scored on the 11 point Visual Analogic Scale, recorded and analysed.\n No statistical difference were noted during the procedure itself in both groups of treatment. Patients treated with DEX has significantly less postoperative pain.\n DEX is not superior to mepivacaine in reducing the discomfort of the procedure but does significantly reduce postoperative pain.\n Copyright 2002 Elsevier Science Ireland Ltd.", "To assess whether transcervical intrauterine instillation of local anaesthetic agent reduces pain during diagnostic outpatient hysteroscopy and endometrial biopsy.\n Prospective, randomised, double blind, placebo-controlled trial.\n Outpatient hysteroscopy clinic in a university teaching hospital.\n Ninety women undergoing outpatient diagnostic hysteroscopy with or without endometrial biopsy.\n Transcervical intrauterine instillation of 5 mL of 2% lignocaine into the uterine cavity before performing the procedure.\n Evaluation of pain at different stages of the procedure using a visual analogue scale and changes in blood pressure and heart rate.\n The use of local anaesthetic did not alleviate pain experienced during hysteroscopy and endometrial biopsy. It did not prevent the occurrence of vaso-vagal reactions; however the incidence of these was low.\n Transcervical instillation of local anaesthesia neither reduced pain nor prevented vaso-vagal reaction during hysteroscopy and endometrial biopsy.", "An increasing number of diagnostic hysteroscopies are being performed in an outpatient setting. Most women tolerate the examination well, but the single commonest reason for failure is pain. We assessed the efficacy of a nonsteroidal, anti-inflammatory analgesic as premedication before hysteroscopy in a double-blind, placebo controlled trial. Our results showed that 500 mg mefenamic acid given one hour before hysteroscopy had no significant benefit in the discomfort experienced during the procedure but did significantly reduce pain after hysteroscopy. A larger dose or a longer interval between premedication and hysteroscopy may possibly be associated with greater benefits.", "To assess the efficacy of lidocaine spray during outpatient hysteroscopy for reducing procedure-related pain and to identify risk factors for discomfort.\n One hundred twenty-one women were assigned randomly to have application of lidocaine spray or placebo to the uterine cervix during outpatient hysteroscopy. The main outcome measure was pain during hysteroscopy, assessed on a visual analog scale.\n There was no statistically significant difference between study and control groups in mean age, rate of nulliparity, postmenopausal state, need for cervical dilation, or percentage of women who used hormone replacement therapy. Indications for diagnostic hysteroscopy were similar between groups. Women in the lidocaine group had statistically significantly less pain during the procedure than women in the placebo group (2.2 +/- 1.9 and 3.7 +/- 2.5, respectively; P <.001). Women with abnormal uterine findings (submucous myoma, endometrial polyps, or intrauterine adhesions) had significantly higher pain scores than women with normal cavities (2.2 +/- 1.9 and 3.2 +/- 2.4, respectively; P <.002). Aerosol anesthesia and normal uterine findings were independently associated with less pain. No procedure had to be abandoned because of excessive pain or complications, and no women required hospitalization.\n Women treated with lidocaine spray had significantly less pain. Uterine cavity abnormality might be associated with a higher degree of pain during hysteroscopy.", "nan" ]

[ "11320369", "10051289", "10955375", "12660683", "10338459", "9316528", "13678870", "12208593", "9074572", "19001508", "9740480", "7608448", "10477530", "10740141", "13678871", "10821361", "10750252", "11759645" ]

[ "ADEPT: Addition of the AT1 receptor antagonist eprosartan to ACE inhibitor therapy in chronic heart failure trial: hemodynamic and neurohormonal effects.", "Addition of angiotensin II receptor blockade to maximal angiotensin-converting enzyme inhibition improves exercise capacity in patients with severe congestive heart failure.", "Meta-analysis of observed mortality data from all-controlled, double-blind, multiple-dose studies of losartan in heart failure. Losartan Heart Failure Mortality Meta-analysis Study Group.", "Acute and 3-month treatment effects of candesartan cilexetil on hemodynamics, neurohormones, and clinical symptoms in patients with congestive heart failure.", "Augmented short- and long-term hemodynamic and hormonal effects of an angiotensin receptor blocker added to angiotensin converting enzyme inhibitor therapy in patients with heart failure. Vasodilator Heart Failure Trial (V-HeFT) Study Group.", "Comparative effects of losartan and enalapril on exercise capacity and clinical status in patients with heart failure. The Losartan Pilot Exercise Study Investigators.", "Effects of candesartan in patients with chronic heart failure and reduced left-ventricular systolic function intolerant to angiotensin-converting-enzyme inhibitors: the CHARM-Alternative trial.", "Safety and efficacy of valsartan versus enalapril in heart failure patients.", "Randomised trial of losartan versus captopril in patients over 65 with heart failure (Evaluation of Losartan in the Elderly Study, ELITE)", "Irbesartan in patients with heart failure and preserved ejection fraction.", "Valsartan in heart failure patients previously untreated with an ACE inhibitor.", "Comparison of the effects of losartan and enalapril on clinical status and exercise performance in patients with moderate or severe chronic heart failure.", "Comparison of candesartan, enalapril, and their combination in congestive heart failure: randomized evaluation of strategies for left ventricular dysfunction (RESOLVD) pilot study. The RESOLVD Pilot Study Investigators.", "Randomized trial of candesartan cilexetil in the treatment of patients with congestive heart failure and a history of intolerance to angiotensin-converting enzyme inhibitors.", "Effects of candesartan in patients with chronic heart failure and preserved left-ventricular ejection fraction: the CHARM-Preserved Trial.", "Effect of losartan compared with captopril on mortality in patients with symptomatic heart failure: randomised trial--the Losartan Heart Failure Survival Study ELITE II.", "A study of the efficacy and safety of irbesartan in combination with conventional therapy, including ACE inhibitors, in heart failure. Irbesartan Heart Failure Group.", "A randomized trial of the angiotensin-receptor blocker valsartan in chronic heart failure." ]

[ "Persistent activation of the renin-angiotensin-aldosterone-system (RAAS) is known to occur in patients with chronic heart failure (CHF) despite treatment with angiotensin-converting enzyme inhibitor (ACE) therapy. When added to ACE inhibitors, angiotensin II type 1 (AT1) antagonists may allow more complete blockade of the RAAS and preserve the beneficial effects of bradykinin accumulation not seen with AT1 receptor blockade alone.\n Thirty-six patients with stable New York Heart Association class II-IV CHF receiving ACE inhibitor therapy were randomly assigned in a double-blind manner to receive either eprosartan, a specific competitive AT1 receptor antagonist (400 to 800 mg daily, n = 18) or placebo (n = 18) for 8 weeks. The primary outcome measure was left ventricular ejection fraction (LVEF) as measured by radionuclide ventriculography, and secondary measures were central hemodynamics assessed by Swan-Ganz catheterization and neurohormonal effects.\n There was no change in LVEF with eprosartan therapy (mean relative LVEF percentage change [SEM] +10.5% [9.3] vs +10.1% [5.0], respectively; difference, 0.4; 95% confidence interval [CI], -20.8 to 21.7; P =.97). Eprosartan was associated with a significant reduction in diastolic blood pressure and a trend toward a reduction in systolic blood pressure compared with placebo (-7.3 mm Hg [95% CI, -14.2 to -0.4] diastolic; -8.9 mm Hg [95% CI, -18.6 to 0.8] systolic). No significant change in heart rate or central hemodynamics occurred during treatment with eprosartan compared with placebo. A trend toward an increase in plasma renin activity was noted with eprosartan therapy. Eprosartan was well tolerated, with an adverse event profile similar to placebo, whereas kidney function remained unchanged.\n When added to an ACE inhibitor, eprosartan reduced arterial pressure without increasing heart rate. There was no change in LVEF after 2 months of therapy with eprosartan.", "Incomplete suppression of the renin-angiotensin system during long-term ACE inhibition may contribute to symptomatic deterioration in patients with severe congestive heart failure (CHF). Combined angiotensin II type I (AT1) receptor blockade and ACE inhibition more completely suppresses the activated renin-angiotensin system than either intervention alone in sodium-depleted normal individuals. Whether AT1 receptor blockade with losartan improves exercise capacity in patients with severe CHF already treated with ACE inhibitors is unknown.\n Thirty-three patients with severe CHF despite treatment with maximally recommended or tolerated doses of ACE inhibitors were randomized 1:1 to receive 50 mg/d losartan or placebo for 6 months in addition to standard therapy in a multicenter, double-blind trial. Peak aerobic capacity (V(O2)) during symptom-limited treadmill exercise and NYHA functional class were determined at baseline and after 3 and 6 months of double-blind therapy. Peak V(O2) at baseline and after 3 and 6 months were 13.5+/-0.6, 15.1+/-1.0, and 15.7+/-1.1 mL. kg-1. min-1, respectively, in patients receiving losartan and 14.1+/-0.6, 14.3+/-0.9, and 13.6+/-1.1 mL. kg-1. min-1, respectively, in patients receiving placebo (P<0.02 for treatment group-by-time interaction). Functional class improved by at least one NYHA class in 9 of 16 patients receiving losartan and 1 of 17 patients receiving placebo.\n Losartan enhances peak exercise capacity and alleviates symptoms in patients with CHF who are severely symptomatic despite treatment with maximally recommended or tolerated doses of ACE inhibitors.", "Clinical studies of heart failure utilizing losartan, an angiotensin-II receptor antagonist, found that this drug is well tolerated and demonstrates hemodynamic, neurohormonal, and symptomatic improvement. To assess all-cause mortality in heart failure patients treated with losartan, a meta-analysis including 1,896 patients was performed on 6 controlled, double-blind, multiple-dose studies, regardless of sample size or duration of follow-up. A combination of logarithmic (log) odds ratios with a continuity correction was utilized for the meta-analysis. Treatment groups were comparable with regard to demographic characteristics, heart failure characteristics, and concomitant cardiovascular therapies. Concomitant use of open-label angiotensin-converting enzyme (ACE) inhibitors was not allowed in any study. The mean left ventricular ejection fraction obtained in individual studies ranged from 23% to 31%. Seven hundred forty patients were randomized to control therapy and 1,154 patients were randomized to losartan therapy. There were 36 deaths (3.12%) in the losartan groups compared with 47 in the control groups (6.35%) during the double-blind periods. The odds of dying in the losartan groups were 0.51 times (0.31 to 0.81) that of dying in the control groups (p = 0.004). In this analysis, treatment with losartan provided a beneficial effect upon survival. However, because the number of deaths in these studies is relatively small and the follow-up relatively short, a large confirmatory study is needed to assess the mortality benefit of losartan compared with an ACE inhibitor.", "This study evaluated the short-term and long-term effects of the angiotensin II type 1 receptor antagonist candesartan cilexetil on hemodynamics, neurohormones, and clinical symptoms in patients with congestive heart failure (CHF).\n In this multicenter, double-blind, parallel-group study, 218 patients with CHF (New York Heart Association class II or III) with impaired left ventricular function (ejection fraction < or =40%) and pulmonary capillary wedge pressure > or =13 mm Hg were randomly assigned to 12 weeks of treatment with placebo (n = 44) or candesartan cilexetil (2 mg [n = 45], 4 mg [n = 46], 8 mg [n = 39], or 16 mg [n = 44]) once daily after a 2-week placebo run-in period. Hemodynamic measurements were performed by right heart catheterization over a 24-hour period after single (day 1) and repeated (3-month) treatment with the study drug.\n On regression analysis of the time-response curves, single and multiple doses of candesartan cilexetil produced sustained, significant, and dose-dependent reductions in pulmonary capillary wedge pressure (short-term effect P =.036, long-term effect P =.035) and mean pulmonary arterial pressure (short-term effect P =.031, long-term effect P =.042). Systemic vascular resistance showed a trend toward decreasing with dose on short-term and long-term treatments. No consistent changes were seen in cardiac index. Compensatory increases in plasma renin activity and angiotensin II levels with decreases in aldosterone and atrial natriuretic peptide were dose-dependent and significant. Candesartan cilexetil improved clinical symptoms, stabilized patient New York Heart Association status compared with placebo, and was judged to be an efficacious treatment by the investigators. More patients receiving placebo stopped the trial prematurely because of an adverse event than in any candesartan cilexetil group, and there was no excess of deaths in any treatment group. Candesartan was safe and well tolerated at all dosages.\n Candesartan cilexetil demonstrated significant short-term and long-term improvements in hemodynamic, neurohormonal, and symptomatic status and was well tolerated in patients with CHF.", "ACE inhibitors may not adequately suppress deleterious levels of angiotensin II in patients with heart failure. An angiotensin receptor blocker added to an ACE inhibitor may exert additional beneficial effects.\n Eighty-three symptomatic stable patients with chronic heart failure receiving long-term ACE inhibitor therapy were randomly assigned to double-blind treatment with valsartan 80 mg BID, valsartan 160 mg BID, or placebo while receiving their usual ACE inhibitor therapy. Studies were performed before and after the first dose of the test drug and again after 4 weeks of therapy. A single dose of lisinopril was administered during study days to ensure sustained ACE inhibition. Compared with placebo, the first dose of valsartan 160 mg resulted in a significantly greater reduction in pulmonary capillary wedge pressure at 3, 4, and 8 hours and during the prespecified 4- to 8-hour interval after the dose and in systolic blood pressure at 2, 3, 6, 8, and 12 hours and 4 to 8 hours after the dose. A pressure reduction from valsartan 80 mg did not achieve statistical significance. After 4 weeks of therapy, net reductions in 0-hour trough pulmonary capillary wedge pressure (-4.3 mm Hg; P=0. 16), pulmonary artery diastolic pressure (-4.7 mm Hg; P=0.013), and systolic blood pressure (-6.8 mm Hg; P=0.013) were observed in the valsartan 160 mg group compared with placebo. After 4 weeks of therapy, plasma aldosterone was reduced by valsartan 80 mg BID (-52. 1 pg/mL; P=0.001) and 160 mg BID (-47.8 pg/mL; P<0.001) compared with placebo, and there was a trend for a reduction in plasma norepinephrine (-97 pg/mL; P=0.10). Seventy-four of the 83 patients completed the trial.\n Physiologically active levels of angiotensin II persist during standard long-term ACE inhibitor therapy.", "This study was designed to determine 1) whether 12-week oral administration of losartan, an angiotensin II receptor antagonist, in patients with heart failure is well tolerated; and 2) whether functional capacity and clinical status of patients with heart failure in whom treatment with an angiotensin-converting enzyme (ACE) inhibitor is replaced with losartan for 12 weeks will remain similar to that noted in patients in whom treatment with an ACE inhibitor is continued.\n Losartan is a specific, nonpeptide angiotensin II receptor antagonist. Although specific receptor blockade with losartan has certain theoretic advantages over nonspecific ACE inhibition, definitive demonstration of comparable effects in patients with congestive heart failure is lacking.\n A double-blind, multicenter, randomized, parallel, enalapril-controlled study was conducted in 116 patients with congestive heart failure (New York Heart Association functional classes II to IV) and left ventricular ejection fraction < or = 45% previously treated with stable doses of ACE inhibitors and diuretic agents, with or without concurrent digitalis and other vasodilators. After a baseline exercise period, open-label ACE inhibitors were discontinued, and patients were randomly assigned to 12 weeks of therapy with losartan, 25 mg/day (n = 38); losartan, 50 mg/day (n = 40); or enalapril, 20 mg/day (n = 38). Drug efficacy was evaluated by changes in maximal treadmill exercise time (using a modified Naughton protocol), 6-min walk test, left ventricular ejection fraction and dyspnea-fatigue index. Safety was measured by the incidence of clinical and laboratory adverse experiences.\n The treadmill exercise time and the 6-min walk test did not change significantly after replacement of ACE inhibitor therapy with losartan. Similarly, a significant change was not observed in either the dyspnea-fatigue index or left ventricular ejection fraction at the end of double-blind period relative to baseline.\n Losartan was generally well tolerated and comparable to enalapril in terms of exercise tolerance in this short-term (12-week) study of patients with heart failure. The clinical effects of long-term angiotensin II receptor blockade compared with ACE inhibition remain to be studied.", "Angiotensin-converting-enzyme (ACE) inhibitors improve outcome of patients with chronic heart failure (CHF). A substantial proportion of patients, however, experience no benefit from ACE inhibitors because of previous intolerance. We aimed to find out whether candesartan, an angiotensin-receptor blocker, could improve outcome in such patients not taking an ACE inhibitor.\n Between March, 1999, and March, 2001, we enrolled 2028 patients with symptomatic heart failure and left-ventricular ejection fraction 40% or less who were not receiving ACE inhibitors because of previous intolerance. Patients were randomly assigned candesartan (target dose 32 mg once daily) or matching placebo. The primary outcome of the study was the composite of cardiovascular death or hospital admission for CHF. Analysis was by intention to treat.\n The most common manifestation of ACE-inhibitor intolerance was cough (72%), followed by symptomatic hypotension (13%) and renal dysfunction (12%). During a median follow-up of 33.7 months, 334 (33%) of 1013 patients in the candesartan group and 406 (40%) of 1015 in the placebo group had cardiovascular death or hospital admission for CHF (unadjusted hazard ratio 0.77 [95% CI 0.67-0.89], p=0.0004; covariate adjusted 0.70 [0.60-0.81], p<0.0001). Each component of the primary outcome was reduced, as was the total number of hospital admissions for CHF. Study-drug discontinuation rates were similar in the candesartan (30%) and placebo (29%) groups.\n Candesartan was generally well tolerated and reduced cardiovascular mortality and morbidity in patients with symptomatic chronic heart failure and intolerance to ACE inhibitors.", "Although a cornerstone in the treatment of heart failure, angiotensin-converting enzyme inhibitors are under-used, partly due to side effects. If proven at least similarly efficacious to angiotensin-converting enzyme inhibitors, angiotensin-receptor blockers may replace them due to their superior tolerability. We aimed to compare the efficacy and safety of valsartan and enalapril in heart failure patients stabilised on an angiotensin-converting enzyme inhibitor. We randomised 141 patients (mean 68 years, 74% males) with stable mild/moderate heart failure and left ventricular ejection fraction 0.45 or less, to valsartan 160 mg q.d. (n=70) or enalapril 10 mg b.i.d. (n=71) for 12 weeks. Changes in 6-min-walk test (primary efficacy variable), patients' wellbeing and left ventricular size and function did not differ significantly between the treatment groups. Valsartan was significantly non-inferior to enalapril in walk test distance change: least-square means treatment difference +1.12 m (95% confidence interval -21.9 to 24.1), non-inferiority P<0.001. Left ventricular size (P<0.001) and function (P=0.048) improved significantly only in the valsartan group. Fewer patients experienced adverse events in the valsartan group (50%) than in the enalapril group (63%), although statistically non-significant. Valsartan is similarly efficacious and safe to enalapril in patients with stable, mild/moderate heart failure, previously stabilised on an angiotensin-converting enzyme inhibitor and directly switched to study medication.", "To determine whether specific angiotensin II receptor blockade with losartan offers safety and efficacy advantages in the treatment of heart failure over angiotensin-converting-enzyme (ACE) inhibition with captopril, the ELITE study compared losartan with captopril in older heart-failure patients.\n We randomly assigned 722 ACE inhibitor naive patients (aged 65 years or more) with New York Heart Association (NYHA) class II-IV heart failure and ejection fractions of 40% or less to double-blind losartan (n = 352) titrated to 50 mg once daily or captopril (n = 370) titrated to 50 mg three times daily, for 48 weeks. The primary endpoint was the tolerability measure of a persisting increase in serum creatinine of 26.5 mumol/L or more (> or = 0.3 mg/dL) on therapy; the secondary endpoint was the composite of death and/or hospital admission for heart failure; and other efficacy measures were total mortality, admission for heart failure, NYHA class, and admission for myocardial infarction or unstable angina.\n The frequency of persisting increases in serum creatinine was the same in both groups (10.5%). Fewer losartan patients discontinued therapy for adverse experiences (12.2% vs 20.8% for captopril, p = 0.002). No losartan-treated patients discontinued due to cough compared with 14 in the captopril group. Death and/or hospital admission for heart failure was recorded in 9.4% of the losartan and 13.2% of the captopril patients (risk reduction 32% [95% CI -4% to + 55%], p = 0.075). This risk reduction was primarily due to a decrease in all-cause mortality (4.8% vs 8.7%; risk reduction 46% [95% CI 5-69%], p = 0.035). Admissions with heart failure were the same in both groups (5.7%), as was improvement in NYHA functional class from baseline. Admission to hospital for any reason was less frequent with losartan than with captopril treatment (22.2% vs 29.7%).\n In this study of elderly heart-failure patients, treatment with losartan was associated with an unexpected lower mortality than that found with captopril. Although there was no difference in renal dysfunction, losartan was generally better tolerated than captopril and fewer patients discontinued losartan therapy. A further trial, evaluating the effects of losartan and captopril on mortality and morbidity in a larger number of patients with heart failure, is in progress.", "Approximately 50% of patients with heart failure have a left ventricular ejection fraction of at least 45%, but no therapies have been shown to improve the outcome of these patients. Therefore, we studied the effects of irbesartan in patients with this syndrome.\n We enrolled 4128 patients who were at least 60 years of age and had New York Heart Association class II, III, or IV heart failure and an ejection fraction of at least 45% and randomly assigned them to receive 300 mg of irbesartan or placebo per day. The primary composite outcome was death from any cause or hospitalization for a cardiovascular cause (heart failure, myocardial infarction, unstable angina, arrhythmia, or stroke). Secondary outcomes included death from heart failure or hospitalization for heart failure, death from any cause and from cardiovascular causes, and quality of life.\n During a mean follow-up of 49.5 months, the primary outcome occurred in 742 patients in the irbesartan group and 763 in the placebo group. Primary event rates in the irbesartan and placebo groups were 100.4 and 105.4 per 1000 patient-years, respectively (hazard ratio, 0.95; 95% confidence interval [CI], 0.86 to 1.05; P=0.35). Overall rates of death were 52.6 and 52.3 per 1000 patient-years, respectively (hazard ratio, 1.00; 95% CI, 0.88 to 1.14; P=0.98). Rates of hospitalization for cardiovascular causes that contributed to the primary outcome were 70.6 and 74.3 per 1000 patient-years, respectively (hazard ratio, 0.95; 95% CI, 0.85 to 1.08; P=0.44). There were no significant differences in the other prespecified outcomes.\n Irbesartan did not improve the outcomes of patients with heart failure and a preserved left ventricular ejection fraction. (ClinicalTrials.gov number, NCT00095238.)\n 2008 Massachusetts Medical Society", "To evaluate the effect on cardiac hemodynamic parameters of valsartan in patients with chronic stable congestive heart failure previously untreated with ACE inhibitors.\n After a 2 to 4 week run-in period, 116 adult outpatients were randomized to receive valsartan 40, 80 or 160 mg twice daily, the ACE inhibitor lisinopril 5/10 mg once daily, or placebo. At baseline and after 28 days of treatment, cardiac hemodynamic parameters were measured. Tolerability was assessed by adverse events and by any changes in systolic or diastolic blood pressure, body weight, heart rate, and routine laboratory parameters.\n For the 12 hour time point (trough), all doses of valsartan reduced mean pulmonary capillary wedge pressure (statistically significant for valsartan 40 mg and 160 mg), decreased systemic vascular resistance (statistically significant for all three valsartan doses and for lisinopril at peak and trough), and increased cardiac output (statistically significant for all three valsartan doses at peak, and for 80 and 160 mg at trough). There were no clinically relevant effects on any safety parameters.\n Valsartan has beneficial effects on cardiac hemodynamics, and is generally well tolerated in patients with congestive heart failure not taking ACE inhibitors.", "This study assessed the feasibility of an efficacy trial comparing angiotensin-converting enzyme inhibition and angiotensin II receptor antagonism in heart failure. Patients with moderate or severe heart failure whose condition had previously been stabilized by treatment with a converting enzyme inhibitor were randomly assigned to receive enalapril or losartan. The study was designed to detect any signs of clinical deterioration during double-blind treatment.\n Losartan is a specific, nonpeptide angiotensin II receptor-1 antagonist with a vasodilator hemodynamic profile similar to that of converting enzyme inhibitors. Although therapy with specific receptor blockade has certain theoretic advantages over nonspecific converting enzyme inhibition, demonstration of a comparable therapeutic effect in patients with congestive heart failure will require a major effort comparing two active agents.\n One hundred sixty-six patients with stable heart failure in New York Heart Association functional class III or IV and an ejection fraction < or = 35% were included in a multicenter, double-blind, parallel, enalapril-controlled trial. After a 3-week stabilization period with optimal therapy, including digitalis, diuretic drugs and a converting enzyme inhibitor, patients were randomly assigned to 8 weeks of therapy with losartan, 25 mg/day (n = 52); losartan, 50 mg/day (n = 56); or enalapril, 20 mg/day (n = 58). Patients were assessed with frequent clinical and laboratory evaluation and exercise testing.\n No significant differences between groups in terms of changes in exercise capacity (6-min walk test), clinical status (dyspnea-fatigue index), neurohumoral activation (norepinephrine, N-terminal atrial natriuretic factor), laboratory evaluation or incidence of adverse experience were observed.\n The results suggest that losartan and enalapril are of comparable efficacy and tolerability in the short-term treatment of moderate or severe congestive heart failure. A trial designed to compare the efficacy, tolerability and effect on mortality of long-term angiotensin II receptor blockade with converting enzyme inhibition is both feasible and ethically responsible.", "We investigated the effects of candesartan (an angiotensin II antagonist) alone, enalapril alone, and their combination on exercise tolerance, ventricular function, quality of life (QOL), neurohormone levels, and tolerability in congestive heart failure (CHF).\n Seven hundred sixty-eight patients in New York Heart Association functional class (NYHA-FC) II to IV with ejection fraction (EF) <0.40 and a 6-minute walk distance (6MWD) <500 m received either candesartan (4, 8, or 16 mg), candesartan (4 or 8 mg) plus 20 mg of enalapril, or 20 mg of enalapril for 43 weeks. There were no differences among groups with regard to 6MWD, NYHA-FC, or QOL. EF increased (P=NS) more with candesartan-plus-enalapril therapy (0.025+/-0.004) than with candesartan alone (0.015+/-0.004) or enalapril alone(0.015+/-0.005). End-diastolic (EDV) and end-systolic (ESV) volumes increased less with combination therapy (EDV 8+/-4 mL; ESV 1+/-4 mL; P<0.01) than with candesartan alone (EDV 27+/-4 mL; ESV 18+/-3 mL) or enalapril alone (EDV 23+/-7 mL; ESV 14+/-6 mL). Blood pressure decreased with combination therapy (6+/-1/4+/-1 mm Hg) compared with candesartan or enalapril alone (P<0.05). Aldosterone decreased (P<0.05) with combination therapy (23.2+/-5.3 pg/mL) at 17 but not 43 weeks compared with candesartan (0.7+/-7.8 pg/mL) or enalapril (-0.8+/-11. 3 pg/mL). Brain natriuretic peptide decreased with combination therapy (5.8+/-2.7 pmol/L; P<0.01) compared with candesartan (4. 4+/-3.8 pmol/L) and enalapril alone (4.0+/-5.0 pmol/L).\n Candesartan alone was as effective, safe, and tolerable as enalapril. The combination of candesartan and enalapril was more beneficial for preventing left ventricular remodeling than either candesartan or enalapril alone.", "Many patients with congestive heart failure do not receive the benefits of angiotensin-converting enzyme (ACE) inhibitors because of intolerance. We sought to determine the tolerability of an angiotensin II receptor blocker, candesartan cilexetil, among patients considered intolerant of ACE inhibitors.\n Patients with CHF, left ventricular ejection fraction less than 35%, and history of discontinuing an ACE inhibitor because of intolerance underwent double-blind randomization in a 2:1 ratio to receive candesartan (n = 179) or a placebo (n = 91). The initial dosage of candesartan was 4 mg/d; the dosage was increased to 16 mg/d if the drug was tolerated. A history of intolerance of ACE inhibitor was attributed to cough (67% of patients), hypotension (15%), or renal dysfunction (11%).\n The study drug was continued for 12 weeks by 82.7% of patients who received candesartan versus 86.8% of patients who received the placebo. This 4.1% greater discontinuation rate with active therapy was not significant; the 95% confidence interval ranged from 4.8% more discontinuation with placebo to 13% more with candesartan. Titration to the 16-mg target dose was possible for 69% of patients who received candesartan versus 84% of those who received the placebo. Frequencies of death and morbidity were not significantly different between the candesartan and placebo groups (death 3.4% and 3.3%, worsening heart failure 8.4% and 13.2%, myocardial infarction 2.8% and 5.5%, all-cause hospitalization 12.8% and 18.7%, and death or hospitalization for heart failure 11.7% and 14.3%).\n Candesartan was well tolerated by this population. The effect of candesartan on major clinical end points, including death, remains to be determined.", "Half of patients with chronic heart failure (CHF) have preserved left-ventricular ejection fraction (LVEF), but few treatments have specifically been assessed in such patients. In previous studies of patients with CHF and low LVEF or vascular disease and preserved LVEF, inhibition of the renin-angiotensin system is beneficial. We investigated the effect of addition of an angiotensin-receptor blocker to current treatments.\n Between March, 1999, and July, 2000, we randomly assigned 3023 patients candesartan (n=1514, target dose 32 mg once daily) or matching placebo (n=1509). Patients had New York Heart Association functional class II-IV CHF and LVEF higher than 40%. The primary outcome was cardiovascular death or admission to hospital for CHF. Analysis was done by intention to treat.\n Median follow-up was 36.6 months. 333 (22%) patients in the candesartan and 366 (24%) in the placebo group experienced the primary outcome (unadjusted hazard ratio 0.89 [95% CI 0.77-1.03], p=0.118; covariate adjusted 0.86 [0.74-1.0], p=0.051). Cardiovascular death did not differ between groups (170 vs 170), but fewer patients in the candesartan group than in the placebo group were admitted to hospital for CHF once (230 vs 279, p=0.017) or multiple times. Composite outcomes that included non-fatal myocardial infarction and non-fatal stroke showed similar results to the primary composite (388 vs 429; unadjusted 0.88 [0.77-1.01], p=0.078; covariate adjusted 0.86 [0.75-0.99], p=0.037).\n Candesartan has a moderate impact in preventing admissions for CHF among patients who have heart failure and LVEF higher than 40%.", "The ELITE study showed an association between the angiotensin II antagonist losartan and an unexpected survival benefit in elderly heart-failure patients, compared with captopril, an angiotensin-converting-enzyme (ACE) inhibitor. We did the ELITE II Losartan Heart Failure Survival Study to confirm whether losartan is superior to captopril in improving survival and is better tolerated.\n We undertook a double-blind, randomised, controlled trial of 3,152 patients aged 60 years or older with New York Heart Association class II-IV heart failure and ejection fraction of 40% or less. Patients, stratified for beta-blocker use, were randomly assigned losartan (n=1,578) titrated to 50 mg once daily or captopril (n=1,574) titrated to 50 mg three times daily. The primary and secondary endpoints were all-cause mortality, and sudden death or resuscitated arrest. We assessed safety and tolerability. Analysis was by intention to treat.\n Median follow-up was 555 days. There were no significant differences in all-cause mortality (11.7 vs 10.4% average annual mortality rate) or sudden death or resuscitated arrests (9.0 vs 7.3%) between the two treatment groups (hazard ratios 1.13 [95.7% CI 0.95-1.35], p=0.16 and 1.25 [95% CI 0.98-1.60], p=0.08). Significantly fewer patients in the losartan group (excluding those who died) discontinued study treatment because of adverse effects (9.7 vs 14.7%, p<0.001), including cough (0.3 vs 2.7%).", "Because heart failure therapy with angiotensin-converting enzyme (ACE) inhibitors may not be optimal, owing to persistent levels of angiotensin II occurring through incomplete blockade and alternate pathways, the benefit of adding irbesartan, an angiotensin receptor antagonist, to conventional therapy, including ACE inhibitors, was examined. In this multicentre, randomised, double-blind, placebo-controlled study, 109 patients with heart failure (New York Heart Association functional class II and III) and left ventricular ejection fraction (LVEF) < or = 40% received stable doses of ACE inhibitors and diuretics before and throughout the study. Irbesartan was titrated as tolerated to 150 mg once daily in all patients. Exercise tolerance time (ETT), LVEF and clinical status were assessed at baseline and after 12 weeks. Compared with placebo, irbesartan in combination with conventional therapy, including ACE inhibitors, produced favourable trends in ETT and LVEF and was well tolerated in patients with mild to moderate heart failure.", "Actions of angiotensin II may contribute to the progression of heart failure despite treatment with currently recommended drugs. We therefore evaluated the long-term effects of the addition of the angiotensin-receptor blocker valsartan to standard therapy for heart failure.\n A total of 5010 patients with heart failure of New York Heart Association (NYHA) class II, III, or IV were randomly assigned to receive 160 mg of valsartan or placebo twice daily. The primary outcomes were mortality and the combined end point of mortality and morbidity, defined as the incidence of cardiac arrest with resuscitation, hospitalization for heart failure, or receipt of intravenous inotropic or vasodilator therapy for at least four hours.\n Overall mortality was similar in the two groups. The incidence of the combined end point, however, was 13.2 percent lower with valsartan than with placebo (relative risk, 0.87; 97.5 percent confidence interval, 0.77 to 0.97; P=0.009), predominantly because of a lower number of patients hospitalized for heart failure; 455 (18.2 percent) in the placebo group and 346 (13.8 percent) in the valsartan group (P<0.001). Treatment with valsartan also resulted in significant improvements in NYHA class, ejection fraction, signs and symptoms of heart failure, and quality of life as compared with placebo (P<0.01). In a post hoc analysis of the combined end point and mortality in subgroups defined according to base-line treatment with angiotensin-converting-enzyme (ACE) inhibitors or beta-blockers, valsartan had a favorable effect in patients receiving neither or one of these types of drugs but an adverse effect in patients receiving both types of drugs.\n Valsartan significantly reduces the combined end point of mortality and morbidity and improves clinical signs and symptoms in patients with heart failure, when added to prescribed therapy. However, the post hoc observation of an adverse effect on mortality and morbidity in the subgroup receiving valsartan, an ACE inhibitor, and a beta-blocker raises concern about the potential safety of this specific combination." ]

[ "12578294", "20530110", "17200252" ]

[ "Randomized controlled trial of heparin for prevention of blockage of peripherally inserted central catheters in neonates.", "A randomised, controlled trial of heparin in total parenteral nutrition to prevent sepsis associated with neonatal long lines: the Heparin in Long Line Total Parenteral Nutrition (HILLTOP) trial.", "A randomized, controlled trial of heparin versus placebo infusion to prolong the usability of peripherally placed percutaneous central venous catheters (PCVCs) in neonates: the HIP (Heparin Infusion for PCVC) study." ]

[ "To determine whether the addition of heparin to total parenteral nutrition (TPN) fluid would prevent blockage of peripherally inserted central catheters (PICCs) in neonates.\n This was a randomized, double-blind, controlled study of 66 eligible neonates with PICCs inserted for the administration of TPN. Infants were randomized to receive TPN containing either 1 IU ml(-1) of heparin (n = 35) or no heparin (n = 31).\n There was no significant difference in the incidence of blocked catheters between the two groups of infants (heparin: 14.3%; no-heparin: 22.6%, p = 0.4). Although a higher percentage (62.9%) of infants in the heparin group received a complete course of TPN successfully via PICC than those in the no-heparin group (48.4%), the difference was not statistically significant (p = 0.3). There were no significant differences in the incidence of catheter-related sepsis, hypertriglyceridaemia, hyperbilirubinaemia, coagulopathy or intraventricular haemorrhage between the two groups.\n Addition of heparin to TPN fluid was not associated with a significant reduction in the incidence of blocked PICCs. However, the sample size of this study was too small to exclude even rather marked differences between the groups.", "Infections are common complications of neonatal long lines. Heparin has been shown to prolong the effective duration of neonatal long lines and to reduce the ability of bacteria to adhere to foreign surfaces, but the effect of heparin on rates of infection is uncertain.\n The goal of this study was to evaluate the effect of heparin on the frequency of episodes of catheter-related sepsis (CRS) in infants receiving total parenteral nutrition (TPN) through a neonatal long line.\n This randomised, controlled, double blind, single-centre clinical trial compared heparin at 0.5 IU/ml with no heparin in TPN infused through a neonatal long line, with episodes of CRS as the primary outcome.\n 210 infants were enrolled (TPN with heparin n=102, TPN without heparin n=108). There was a statistically significant reduction in all episodes of culture-positive CRS in those infants with heparin added to the TPN compared with those without heparin (p=0.04; RR 0.57, 95% CI 0.32 to 0.98; number needed to treat 9, 95% CI 4.6 to 212.4).\n The addition of heparin at 0.5 IU/ml to TPN infused through a neonatal long line reduces the incidence of culture-positive CRS.", "Mechanical and infectious complications shorten the effective duration of peripherally inserted central venous catheters. Heparin use to prevent such complications and prolong the usability of peripherally inserted central venous catheters is inconclusive.\n Our goal was to evaluate the effectiveness of heparin in prolonging the usability of peripherally inserted central venous catheters in neonates.\n We performed a multicenter, randomized, controlled trial of heparin infusion (0.5 U/kg per hour) versus placebo for peripherally inserted central venous catheters in neonates. The primary outcome was duration of catheter use. Secondary outcomes were occlusion, catheter-related sepsis, thrombosis, and adverse effects of heparin. To detect a 168-hour (1-week) difference in the duration of catheter use, 192 patients were needed. Kaplan-Meier and Cox regression analyses were performed.\n A total of 201 neonates were enrolled (heparin group: n = 100; control group: n = 101). Baseline demographics were similar between the groups. Duration of catheter use was longer in the infants in the heparin versus the placebo group. Study center, gender, birth weight, and type and position of the catheter were not predictors of duration of catheter use. For those in the heparin versus the placebo group, the incidence of elective catheter removal (therapy completed) was 63% vs 42%, of occlusion was 6% vs 31%, of thrombosis was 20% vs 21%, and of catheter-related sepsis was 10% vs 6%, respectively. No adverse events were noted.\n Heparin infusion prolonged the duration of peripherally inserted central venous catheter usability, which permitted a higher percentage of neonates to complete therapy without increasing adverse effects." ]

[ "32096", "4467158", "927757", "765457", "6529776", "7403993", "418984", "4591821", "6761087", "4604245" ]

[ "Prophylactic clotrimazole treatment to prevent mycoses contamination of the newborn.", "A comparative trial of six day therapy with clotrimazole and nystatin in pregnant patients with vaginal candidiasis.", "Treatment of vulvovaginal candidiasis in pregnancy. A comparative study.", "Monistat cream (miconazole nitrate) a new agent for the treatment of vulvovaginal candidiasis.", "Double-blind investigation of R-42470 (terconazole cream 0.4%) and clotrimazole (cream 1%) for the topical treatment of mycotic vaginitis.", "Efficacy of econazole in the treatment of candidiasis and other vaginal discharges.", "A dose-response study with Monistat cream.", "Comparison of nystatin ('Nystan') and hydrargaphen ('Penotrane') in the treatment of vaginal candidosis in pregnancy.", "Candida albicans vaginitis: the problem is diagnosis, the enigma is treatment.", "Comparative evaluation of Monistat and Mycostatin in the treatment of vulvovaginal candidiasis." ]

[ "nan", "nan", "A carefully controlled comparative study showed miconazole nitrate 2% vaginal cream (Monistat) to be a highly effective agent in the treatment of vaginal candidiasis in pregnant subjects. Miconazole nitrate was significantly more effective than nystatin (Mycostatin) in the treatment of vaginal candidiasis in all three trimesters of pregnancy, and also more effective regardless of whether the candidal infection was primary or recurrent. Observations relating to the safety of this therapy during pregnancy were made and discussed.", "Monistat Cream (miconazole nitrate 2%), a new fungicidal agent indicated for the treatment of vulvovaginal candidiasis, was evaluated in a comparative study with nystatin vaginal tablets (100,-000 units each). A total of 95 pregnant and non-pregnant patients were treated. Miconazole nitrate was administered once daily, at bedtime, for 14 days to 55 pregnant and non-pregnant patients. Overall, 74.5% (41 of 55 patients) were cured with one course of therapy. In contrast, of 40 nystatin-treated patients (both pregnant and non-pregnant) treated twice daily for 15 days, 22 patients (57.8%) were cured with one course of therapy. This difference in cure rates was statistically significant. Side effects were minimal and comparable in the two treatment groups. No recorded instances of birth defects were observed in infants born to mothers in either treatment group. Monistate Cream, in this study, was found to be a safe and effective drug in treating both pregnant and nonpregnant patients with confirmed candidiasis.", "A total of 78 patients took part in a double-blind randomized comparison of the efficacy, acceptability and tolerance of a new antifungal terconazole (R-42470) (cream 0.4%) with the well established and clinically effective clotrimazole (cream 1%) for the topical treatment of mycotic vaginitis. Five grams of cream were applied to the vagina for 7 consecutive days. Twenty non-pregnant and 19 pregnant patients were included in each group. Clinical and mycological controls were carried out one week and one month after completion of therapy and 89.7% of the patients treated with terconazole responded to therapy and 82.1% patients treated with clotrimazole were cured. Statistical analysis showed no significant difference when the results of the terconazole treated patients and the clotrimazole group were compared.", "Three hundred and thirty Black pregnant patients attending the Baragwanath Hospital antenatal clinic were treated for symptomatic vaginal discharge with econazole (Ecostatin; Squibb). Patients with positive Candida albicans cultures were treated for either 7 or 14 days. The results of treatment in both groups are presented.", "A randomized multiregimen clinical study was undertaken using Monistat Cream for the treatment of vulvovaginal candidiasis. The objective of the study was to find if there is a shorter regimen comparable in effectiveness to the currently marketed 14-day regimen. The results indicate that there is no significant difference between the cure rate obtained for 7 days of therapy and for 14 days of therapy.", "nan", "At the UCLA Vulvovaginitis Clinic, 63 patients were diagnosed as having symptomatic Candida albicans vaginal infections. In a random select manner 3-day treatment with 200-mg clotrimazole suppositories was compared with 7-day treatment using 100-mg clotrimazole suppositories. 7- and 35-day follow-up of all patients entered revealed no statistical difference between the two groups, suggesting that short-term treatment is most efficacious and can be expected to work better since patient compliance is primarily a function of duration of treatment. In 50 cases of C. albicans patients treated with miconazole or clotrimazole in a random manner, the recurrence rate was 8 or 16. All patients in the study received perianal cultures for C. albicans before treatment and 7 and 35 days after treatment. 5 of the 8 patients with recurrence had perianal positive cultures at the 7- and 35-day check suggesting this as a source of recurrence. It is suggested that patients with persistently high perianal cultures after treatment be given an oral fungicide or fungistat to lower chronic recurrent C. albicans.", "nan" ]

[ "5947494", "8369231", "843177", "14141840", "13894892", "776312", "13278167", "4869439", "14445663" ]

[ "Differential effects of abrupt versus gradual withdrawal of chlorpromazine in hospitalized chronic schizophrenic patients.", "The clinical relevance of an auditory attention task (PAT) in a longitudinal study of chronic schizophrenia, with placebo substitution for chlorpromazine.", "Prediction of relapse in schizophrenic outpatients treated by drug and sociotherapy.", "DISCONTINUATION OR REDUCTION OF CHEMOTHERAPY IN CHRONIC SCHIZOPHRENICS.", "Prolonged withdrawal of chlorpromazine in chronic patients.", "A controlled trial of phenothiazine withdrawal in chronic schizophrenic patients.", "Use of chlorpromazine and reserpine in the treatment of emotional disorders.", "A study of the withdrawal of chlorpromazine or trifluoperazine in chronic schizophrenia.", "Comparison of chlorpromazine and reserpine in maintenance drug therapy." ]

[ "nan", "A new auditory attention task (PAT) is described. The test comprises four different subtest combinations (diotic/dichotic, slow/fast) each of 5 min duration. Omission and commission errors are combined by an index of errors (IE). The PAT was given fortnightly to 20 chronic schizophrenic inpatients for more than one year. Independent psychiatrists rated the patients according to the Brief Psychiatric Rating Scale and a Global Rating Scale. All measures yielded significant test-retest reliabilities. The patients were stabilized on individualized doses of chlorpromazine (CPZ) and randomized to two groups. Placebo was substituted for CPZ during 10 weeks, according to a double-blind cross-over design. Significant deterioration under placebo was detected by all three methods, but the PAT was the most sensitive to change. The PAT mean score (M IE) was correlated with both rating scales. Unlike the rating scales, it also correctly ordered the twenty patients along a dimension which measured the severity of illness and 'predicted' hospital discharge.", "Despite the established efficacy of neuroleptics for maintaining schizophrenics in the community, there are data suggesting that those with very good prognostic signs may do as well without drugs. In testing this, we find no evidence that patients with good signs are not in need of drugs; instead they profit most from drug treatment. Patients who benefit little (1) are men whose families were disrupted earlier in their lives, (2) live alone or with extended families whose attitudes toward the study are not positive, and (3) are irregular in taking their medication. The practical implication is that the drug nonresponder can be helped by some means to ensure regularity of medication taking, such as a visiting nurse or long-acting medication. A second research question is whether major role therapy (MRT, a combination of social casework and vocational rehabilitation) can lengthen the time until relapse. Major role therapy affected time to relapse in a disordinal manner; asymptomatic patients benefited from MRT, while in patients with greater symptom severity MRT- suprisingly--hastened relapse. It is hypothesized that symptomatic patients are suffering from an inability to manage an expanded and enriched cognitive field; MRT, a therapy that urges the patient to become more responsible and to expand his horizons, may actually induce a state with which the patient cannot cope. It is recommended that a therapy such as MRT be deferred until the patient is essentially asymptomatic.", "nan", "nan", "Phenothiazine drugs were withdrawn from 17 chronic schizophrenic in-patients, with a control group of 14 patients remaining on active medication. The trial was conducted under double blind conditions over a period of 42 weeks with weekly assessment of the patients by ward nurses. Of the placebo group 35% relapsed, relapse being related to the level of previous active medication.", "nan", "nan", "nan" ]

[ "7721556", "10952746", "8971230", "1795315" ]

[ "Balneotherapy for rheumatoid arthritis at the Dead Sea.", "Long-term efficacy of radon spa therapy in rheumatoid arthritis--a randomized, sham-controlled study and follow-up.", "A randomized and controlled trial of hydrotherapy in rheumatoid arthritis.", "Effect of spa therapy in Tiberias on patients with rheumatoid arthritis and osteoarthritis." ]

[ "Thirty-six patients with active rheumatoid arthritis were treated for 12 days at the Ein Gedi Spa. The patients were allocated randomly to four study groups. Group 1 (n = 9) was treated with daily baths in the Dead Sea, group 2 (n = 9) was treated with daily sulphur baths, group 3 (n = 10) was treated with a combination of daily Dead Sea bathing and sulphur baths, and group 4 (n = 8) served as a control group. All patients were assessed by a rheumatologist who was blinded to the treatment modalities and group allocation. Clinical parameters assessed included: duration of morning stiffness, 15 m walk time, grip strength, activities of daily living, patient's assessment of disease severity, number of active joints, and the Ritchie articular index. Statistically significant improvement lasting up to 3 months was observed only in the three treatment groups.", "To quantify the efficacy of a series of baths containing natural radon and carbon dioxide (1.3 kBq/l, 1.6 g carbon dioxide/l on average) versus artificial carbon dioxide baths alone in patients with rheumatoid arthritis.\n Sixty patients participating in an in-patient rehabilitation programme including a series of 15 baths were randomly assigned to two groups.\n Pain intensity (100 mm visual analogue scale) and functional restrictions [Keitel functional test, Arthritis Impact Measurement Scales (AIMS questionnaire)] were measured at baseline, after completion of treatment and 3 and 6 months thereafter. To investigate whether the overall value of the outcomes was the same in both groups, the overall mean was analysed by Student's t-test for independent samples.\n The two groups showed a similar baseline situation. After completion of treatment, relevant clinical improvements were observed in both groups, with no notable group differences. However, the follow-up revealed sustained effects in the radon arm, and a return to baseline levels in the sham arm. After 6 months, marked between-group differences were found for both end-points (pain intensity: -16.9%, 95% confidence interval -27.6 to -6.2%; AIMS score: 0.57, 95% confidence interval 0.16 to 0.98). The between-group differences were statistically significant for both overall means (pain intensity, P: = 0.04; AIMS, P: = 0.01).\n Marked short-term improvements in both groups at the end of treatment may have masked potential specific therapeutic effects of radon baths. However, after 6 months of follow-up the effects were lasting only in patients of the radon arm. This suggests that this component of the rehabilitative intervention can induce beneficial long-term effects.", "The aim of this study was to evaluate the therapeutic effects of hydrotherapy which combines elements of warm water immersion and exercise. It was predicted that hydrotherapy would result in a greater therapeutic benefit than either of these components separately.\n One hundred thirty-nine patients with chronic rheumatoid arthritis were randomly assigned to hydrotherapy, seated immersion, land exercise, or progressive relaxation. Patients attended 30-minute sessions twice weekly for 4 weeks. Physical and psychological measures were completed before and after intervention, and at a 3-month followup.\n All patients improved physically and emotionally, as assessed by the Arthritis Impact Measurement Scales 2 questionnaire. Belief that pain was controlled by chance happenings decreased, signifying improvement. In addition, hydrotherapy patients showed significantly greater improvement in joint tenderness and in knee range of movement (women only). At followup, hydrotherapy patients maintained the improvement in emotional and psychological state.\n Although all patients experienced some benefit, hydrotherapy produced the greatest improvements. This study, therefore, provides some justification for the continued use of hydrotherapy.", "Forty-one patients with rheumatoid arthritis were treated for 2 weeks at a Tiberias spa hotel. Randomized into 2 groups, Group 1 received a combination of mineral baths and mud packs, and Group 2 had tap water baths only. Both groups had a significant but temporary improvement in Ritchie index. Group 1 showed a significant improvement in grip strength. No improvement was noticed in morning stiffness, 15 meter walk time and laboratory variables of disease activity in either group. Twelve patients with osteoarthritis (OA) received 2 weeks of treatment with mineral baths and mud packs. Statistically significant improvement for a period of 6 months was noticed in night pain, pain on passive motion, tenderness on palpation and in the index of severity of OA of the knee." ]

[ "1521497", "9735578", "16392991" ]

[ "Enhanced services and stipends for foster parents: effects on retention rates and outcomes for children.", "Comparison of two community alternatives to incarceration for chronic juvenile offenders.", "Intervention outcomes for girls referred from juvenile justice: effects on delinquency." ]

[ "Current national trends show that although the number of available foster homes is shrinking, the number of children and adolescents being cared for in the family foster care system is growing. This study demonstrates the significant benefits to both foster parents and the children in their care of providing enhanced services and stipends to foster parents.", "The relative effectiveness of group care (GC) and multidimensional treatment foster care (MTFC) was compared in terms of their impact on criminal offending, incarceration rates, and program completion outcomes for 79 male adolescents who had histories of chronic and serious juvenile delinquency. Results show that boys who participated in MTFC had significantly fewer criminal referrals and returned to live with relatives more often. Multiple regression analyses showed that assignment to a treatment condition (i.e., GC or MTFC) predicted official and self-reported criminality in follow-up beyond other well-known predictors of chronic juvenile offending (i.e., age at 1st offense, number of previous offenses, age at referral).", "An increasing number of girls are entering the juvenile justice system. However, intervention programs for delinquent girls have not been examined empirically. The authors examined the 12-month outcomes of a randomized intervention trial for girls with chronic delinquency (N = 81). Girls were randomly assigned into an experimental condition (Multidimensional Treatment Foster Care; MTFC) or a control condition (group care; GC). Analyses of covariance indicated that MTFC youth had a significantly greater reduction in the number of days spent in locked settings and in caregiver-reported delinquency and had 42% fewer criminal referrals than GC youth (a trend) at the 12-month follow-up. Implications for reducing girls' chronic delinquency are discussed." ]

[ "7588918", "4070186", "9224191", "8078862", "9807532", "7740017", "12564572", "12850971", "617630", "10846513", "15230508", "10396552", "3873246", "7856779", "11681560", "9302957", "8222768", "9010903", "8359958", "7749051", "10148752", "8434576", "7762709", "10150535", "8860278", "9428939", "11162337", "10589309", "8633737", "9549451" ]

[ "Cardiovascular risk factor changes in the Kilkenny Health Project. A community health promotion programme.", "Community-based primary prevention of cardiovascular disease in Switzerland: methods and results of the National Research Program (NRP 1A).", "The effectiveness of a media-led intervention to reduce smoking among Vietnamese-American men.", "Results of the Dutch community project \"Healthy Bergeyk\".", "Neighbors for a smoke free north side: evaluation of a community organization approach to promoting smoking cessation among African Americans.", "Evaluation of a Dutch community-based smoking cessation intervention.", "The Finnmark Intervention Study. Better health for the fishery population in an Arctic village in North Norway.", "The Finnmark Intervention Study: is it possible to change CVD risk factors by community-based intervention in an Arctic village in crisis?", "Reducing the risk of cardiovascular disease: effects of a community-based campaign on knowledge and behavior.", "Helping women quit smoking: results of a community intervention program.", "The Dutch Heart Health Community Intervention 'Hartslag Limburg': effects on smoking behaviour.", "Shifting the distribution of risk: results of a community intervention in a Swedish programme for the prevention of cardiovascular disease.", "The community-based strategy to prevent coronary heart disease: conclusions from the ten years of the North Karelia project.", "Changes in adult cigarette smoking in the Minnesota Heart Health Program.", "The Otsego-Schoharie healthy heart program: prevention of cardiovascular disease in the rural US.", "A cost effective, community based heart health promotion project in England: prospective comparative study.", "The effect of a community-based cardiovascular disease prevention project in a Danish municipality.", "A trial of church-based smoking cessation interventions for rural African Americans.", "Community-based intervention: the Coronary Risk Factor Study (CORIS).", "Efficacy of an anti-tobacco community education program in India.", "Smoking cessation in Texas-Mexico border communities: a quasi-experimental panel study.", "Changes in adult cigarette smoking prevalence after 5 years of community health education: the Stanford Five-City Project.", "The Pawtucket Heart Health Program: community changes in cardiovascular risk factors and projected disease risk.", "Evaluation of the Heart To Heart Project: lessons from a community-based chronic disease prevention project.", "Reduction of coronary heart disease risk factors in the German cardiovascular prevention study.", "Change in cardiovascular risk factors during a 10-year community intervention program.", "Effect of a community action program on adult quit smoking rates in rural australian towns: the CART project.", "The impact of a community-based heart disease prevention program in a low-income, inner-city neighborhood.", "Preventing cardiovascular disease through community-based risk reduction: the Bootheel Heart Health Project.", "Effects of the Heartbeat Wales programme over five years on behavioural risks for cardiovascular disease: quasi-experimental comparison of results from Wales and a matched reference area." ]

[ "The Kilkenny Health Project was a community research and demonstration programme which aimed to reduce risk of cardiovascular disease in a county in the south-east of Ireland with a total population of approximately 70,000. The health promotion programme was carried out in Kilkenny from 1985 to 1992. Outcome evaluation was by means of population surveys of independent samples of men and women aged 35 to 64 years in Kilkenny (n approximately 800) and in the reference county (n approximately 600) in 1985/1986 and in 1990/1991. Survey methods for health behaviour questionnaires and risk factor measurements were similar to those of the WHO MONICA Project. Mean systolic blood pressure (SBP) declined significantly (P < 0.01) in men and women in both counties, from 144.0 by 5.4 mmHg and from 143.2 by 5.4 mmHg in men and from 139.5 by 7.7 mmHg and from 136.5 by 6.6 mmHg in women in the intervention and reference counties. The prevalence of hypertension declined from 23.1% by 2.8% and from 26.1% by 6.0% in men in the two counties. Prevalence declined from 24.1% by 6.2% (P < 0.05) in women in the intervention county but was unchanged, increasing by 0.5% from 17.5%, in women in the reference county. Mean serum total cholesterol declined from 6.04 mmol.l-1 by 0.09 mmol.l-1 and from 6.00 by 0.44 mmol.l-1 (P < 0.01) in men and from 6.01 by 0.36 (P < 0.01) and from 5.90 by 0.31 (P < 0.01) in women in the intervention and reference counties, respectively.(ABSTRACT TRUNCATED AT 250 WORDS)", "The National Research Program 1A on Primary Prevention of Cardiovascular Disease in Switzerland was designed to determine whether community health education can reduce cardiovascular risk factors in whole population groups. Two towns (12,000 inhabitants each) in the French-speaking and two (16,000 inhabitants each) in the German-speaking part of the country were selected for either intervention or comparison. Following baseline screening in 1977 (stratified random samples) and the community intervention program (1978-1980), a final assessment on the initial participants was made at the end of 1980. In intervention towns, 26.2% of the regular smokers quit during this period compared with 18.1% in the reference towns. In addition, a significant net increase in the proportion of hypertensive patients under effective control was observed. A reduction in cholesterol levels was noted in both the intervention and the reference towns, with no difference between them. However, cholesterol levels in a subgroup of women participating in program activities as compared with those not participating were significantly reduced. The program, with extensive involvement of a diversity of community groups, has enjoyed continued support, even after the end of the research experience, thus demonstrating the viability and acceptability of community-oriented preventive action.", "This study evaluated an anti-tobacco campaign targeting Vietnamese men in San Francisco, Calif.\n The intervention included Vietnamese-language media, health education materials, and activities targeting physicians, youth, and businesses. Evaluation involved pretest and posttest cross-sectional telephone surveys and multiple logistic regression analyses designed to identify variables associated with smoking and quitting.\n At posttest, the odds of being a smoker were significantly lower (odds ratio [OR] = 0.82, 95% confidence interval [CI] = 0.68, 0.99), and the odds of being a quitter were significantly higher (OR = 1.65, 95% CI = 1.27, 2.15), in San Francisco than in a comparison community.\n Despite modest success, further efforts are needed to reduce smoking among Vietnamese-American men.", "This article reports on the results of a community health project that was implemented in the Dutch municipality of Bergeyk. The major goal was to reduce four cancer-related risk behaviors: smoking, high fat consumption, excessive alcohol use, and exposure to artificial sunlight. A control community received no new intervention. Intervention methods included mass media messages, self-help materials, small group activities, lectures, and structural activities. Community organization principles such as a social network approach, community participation, and intersectoral cooperation were applied in the project.\n Data were collected from both communities among cohort research samples on three occasions using telephone interviews.\n The results indicate a significant reduction in fat intake in the experimental community. No other significant behavioral effects were found. Further analysis among respondents in the experimental condition showed that those personally exposed to the project as indicated by familiarity with and discussion about the project, had a greater decrease in fat consumption between baseline survey and second post-test than those who were not. Also, the percentage of smokers who quit between baseline survey and second post-test was greater among those who knew about the project than among those who did not. Finally, discriminant analysis was used to further examine the determinants of project exposure. Community involvement, marital status, education, and sex were related to project exposure.\n It is concluded that with the time limitations of the project in mind, the findings are encouraging.", "This study evaluated a community organization approach that emphasized involvement of audiences in program planning and implementation in promoting nonsmoking among African American residents of low-income neighborhoods.\n The quasi-experimental design involved a 24-month intervention in 3 low-income, predominantly African American neighborhoods in St. Louis. Intervention neighborhoods were compared with comparable, untreated neighborhoods in Kansas City.\n The program was successful in engaging audience members in its governance and in instigating numerous and diverse neighborhood activities to promote nonsmoking. The prevalence of smoking declined from 34% to 27% in program neighborhoods but only from 34% to 33% in comparison neighborhoods. This difference was apparent within all demographically defined subsamples, indicating that observed changes were consistent and not attributable to confounding by demographic characteristics.\n A community organization approach emphasizing local authority for program decisions and involvement of informal networks may have an appreciable impact on smoking among residents of low-income, African American neighborhoods.", "Until 1990, smoking cessation interventions in the Netherlands were limited. The utility and effectiveness of community-based smoking cessation programs have not been examined.\n In a treatment city (Den Bosch) a multicomponent community-based smoking cessation intervention was implemented in which local mass media and general practitioners draw smokers' attention to a local quit line. Telephone counselors advised applicants on their choice between self-help and group treatment and optional telephone counseling. Another Dutch city (Apeldoorn) served as a control. Population samples of smokers (n = 547 and n = 546) were interviewed three times at approximately 7-month intervals. Self-help manual requesters (n = 84) and group participants (n = 83) were interviewed before and 6 months after treatment.\n Treatment modalities were successful; 13% of self-help manual requesters and 22% of group participants were abstinent after 6 months. On a population level the intervention resulted in significantly higher recall of self-help manual and group program in the treatment city. A modest intervention effect on prevalence of abstinence was found at the community level.\n Treatment modalities were effective within their participants, but the intervention effectiveness on a community level was limited. No significant difference was found between quit rates after 14 months (7% in treatment city and 9% in control city). Several system failures could be identified. However, probably the intervention effect was seriously confounded by two national governmental publicity campaigns introducing and reinforcing a mandatory smoking ban and a series of national campaigns initiated by the united Dutch tobacco producers opposing the ban.", "To evaluate the lifestyle and cardiovascular risk factor changes after 6 years of intervention in the North Cape community.\n Longitudinal cohort study with a quasi-experimental design with one intervention and three control communities selected from the same coastal area with a baseline screening (1987), 6-year intervention, and re-screening (1993).\n Fishing communities on the coast of Finnmark in the Norwegian Arctic area.\n 1685 (70%) of the invited in both screenings, aged between 20 and 62 years in 1987.\n Community-intervention based on empowerment and cooperation between voluntary organisations and local health services.\n Change in cardiovascular risk factors.\n Compared to the control communities, the main findings in North Cape were among men: 21.3% less drinking boiled coffee (p < 0.05), 10.5% more drinking low fat milk (p < 0.01), 0.3 mmol/l reduction in cholesterol (p < 0.01) and 0.2 kg/m2 reduction in BMI (p < 0.001). Among women, there were 5.9% fewer smokers (p < 0.01), 21% less drinking boiled coffee (p < 0.05), 1 kg/m2 less increase in BMI (p < 0.001) and 0.5 less increase in MI risk score (p < 0.05).\n Small close-knit communities are suitable for community-based interventions where it is easier to obtain close interaction between health service, voluntary organisations and the public at large.", "Owing to high cardiovascular mortality, the Norwegian Government introduced the programme \"Health and Inequalities in Finnmark\" in 1988. One of the projects in this programme was aimed at changing cardiovascular risk factors through community-based intervention in a fishing community in the Norwegian Arctic.\n The intervention community Båtsfjord and the three control communities were selected from the same coastal area. The intervention was based on a quasi-experimental design, and evaluated by population surveys before (1987) and after (1993) the invention. The attending cohort was analysed. The intervention method was based on empowerment and cooperation between different organizations, and the primary healthcare system.\n From 1987 - 93, the male cohort in Båtsfjord had a more favourable development when compared with changes in the control communities regarding the 8.6% increase in physical activity (p = 0.047), the reduction in systolic blood pressure by 0.01 mmHg (p = 0.002), and the reduction in diastolic blood pressure by 2.1 mmHg (p < 0.001). The female cohort in Båtsfjord had a more favourable development when compared with changes in the control communities regarding the 11.2% increase in use of low-fat milk (p = 0.046), the increase in systolic blood pressure by 2.1 mmHg (p = 0.024), and the reduction in diastolic blood pressure by 2.1 mmHg (p < 0.001).\n Despite a difficult economic situation for the Arctic coastal communities, the study found it possible for voluntary organizations, local public administration, and local health personnel to promote change in lifestyle and blood pressure using a community intervention approach.", "In 1972 the Stanford Heart Disease Prevention Program launched a three-community field study. A multimedia campaign was conducted for two years in two California communities (Watsonville and Gilroy), in one of which (Watsonville) it was supplemented by an intensive-instruction program with high-risk subjects. A third community (Tracy) was used as a control. The campaigns were designed to increase participants' knowledge of the risk factors for cardiovascular disease, to change such risk-producing behavior as cigarette smoking, and to decrease the participants' dietary intake of calories, salt, sugar, saturated fat, and cholesterol. Results of a sample survey indicate that substantial gains in knowledge, in behavioral modification, and in the estimated risk of cardiovascular disease can be produced by both methods of intervention. The intensive-instruction program, when combined with the mass-medica campaign, emerged as the most effective for those participants who were initially evaluated to be at high risk. The results after two years of intervention are reported for effects on knowledge and behavioral change for the total participant samples and for the high-risk subsamples in each of the three communities.", "This intervention was implemented to reduce the prevalence of cigarette smoking among women.\n We used community organization approaches to create coalitions and task forces to develop and implement a multicomponent intervention in 2 counties in Vermont and New Hampshire, with a special focus on providing support to help women quit smoking. Evaluation was by pre-intervention and post-intervention random-digit-dialed telephone surveys in the intervention counties and the 2 matched comparison counties.\n In the intervention counties, compared with the comparison counties, the odds of a woman being a smoker after 4 years of program activities were 0.88 (95% confidence interval = 0.78, 1.00) (P = .02, 1-tailed); women smokers' perceptions of community norms about women smoking were significantly more negative (P = .002, 1-tailed); and the quit rate in the past 5 years was significantly greater (25.4% vs 21.4%; P = .02, 1-tailed). Quit rates were significantly higher in the intervention counties among younger women (aged 18 to 44 years); among women with household annual incomes of $25,000 or less; and among heavier smokers (those who smoked 25 or more cigarettes daily).\n In these rural counties, community participation in planning and implementing interventions was accompanied by favorable changes in women's smoking behavior.", "A pretest-posttest control group design with two posttests was used to evaluate the effects of a regional Dutch Heart Health Community Intervention on smoking behaviour and its determinants. At baseline, a cohort research population of 1,200 smokers was recruited in the intervention region and in a control region. Data was gathered by means of short structured telephone interviews.\n No significant differences were found between the intervention region and the control region on smoking behaviour and its determinants.\n It is concluded that the regional intervention was unable to exceed secular trends in smoking cessation.", "To examine the impact of a systematic risk factor screening and counselling carried out by family physicians and family nurses within the larger framework of a community intervention programme for the prevention of cardiovascular disease (CVD).\n Quasi-experimental study comparing trends in an intervention area with those in a reference area.\n A Northern Sweden municipality (5500 inhabitants) constituted the intervention area while the Northern Sweden region (510,000 inhabitants) served as the reference area.\n All 30, 40, 50, and 60 year old inhabitants were invited each year from 1985 to 1992. Among 2046 eligible 1893 participated (92.5%), which formed eight independent cross sections. One cross section, 1986, was re-surveyed forming a panel.\n In the cross sections, mean total cholesterol was reduced from 7.09 to 6.27 mmol/l for men (p < 0.001) and from 7.13 to 5.89 mmol/l for women (p < 0.001) and mean systolic blood pressure from 132.2 to 123.7 mm Hg for men (p < 0.05) and from 129.2 to 122.0 mm Hg for women (p < 0.001) during the eight years. Body mass index (BMI) increased from 25.6 to 26.2 for men (p < 0.05) and from 25.0 to 25.5 for women (NS). A corresponding reduction in cholesterol and blood pressure (for women) occurred in the panel, while BMI was unchanged. The risk for CVD, using the Framingham equation, was estimated to be reduced overall by 19% (p = 0.0021) when comparing early cross sections (1985/86) with the later cross sections (1990/91).\n It was concluded that a long term community based CVD prevention programme that combines population and individual strategies can substantially promote a health shift in CVD risk in a high risk rural population. The individual attention and evaluation provided by the health provider survey seem to accelerate, but not increase the amount of, risk reduction.", "nan", "The Minnesota Heart Health Program was a research and demonstration project designed to reduce risk factors for heart disease in whole communities. This paper describes smoking-specific interventions and outcomes.\n Three pairs of matched communities were included in the study. After baseline surveys, one community in each pair received a 5-year education program, while both cross-sectional and cohort surveys continued in all sites. Adult education programs for smoking cessation included Quit and Win contests, classes, self-help materials, telephone support, and home correspondence programs.\n Encouraging short-term results were obtained for several adult education programs. Overall long-term outcomes were mixed, with evidence of an intervention effect only for women in cross-sectional survey data. Unexpectedly strong secular declines in smoking prevalence were observed in comparison communities.\n The findings suggest that community education may be unlikely to exceed dramatic secular reductions in smoking prevalence. The success of several key interventions and the incorporation of Minnesota Heart Health Program interventions by education communities are encouraging, however.", "To describe a rural, hospital-based public health intervention program and to evaluate its effectiveness in cardiovascular disease (CVD) risk reduction using cross-sectional studies and a panel study.\n A rural population of 158,000 located in New York state comprised the intervention population. A similar but separate population was used for reference. A multifaceted, multimedia 5-year program provided health promotion and education initiatives to increase physical activity, decrease smoking, improve nutrition, and identify hypercholesterolemia and hypertension. To evaluate the effectiveness of the intervention, surveys were conducted at baseline in 1989 (cross-sectional) and at follow-up in 1994-95 (cross-sectional and panel). For cross-sectional studies, a random sample of adults was obtained using a three-stage cluster design. Self-reported and objective risk factor measurements were obtained. Comparison of pre- to post- changes in intervention versus reference populations was done using 2 x 2 randomized block ANOVA, 2 x 2 mixed ANOVA. and extension of the McNemar test.\n Smoking prevalence declined (from 27.9% to 17.6%) in the intervention population. Significant adverse trends were observed for high-density lipoprotein cholesterol and triglycerides. Systolic blood pressure was reduced while diastolic blood pressure remained stable. Body mass index increased significantly in both populations.\n This rural. 5-year CVD community intervention program decreased smoking. The risk reduction may be attributable to tailoring of a multifaceted approach (multiple risk factors, multiple messages, and multiple population subgroups) to a target rural population. The study period was too short to identify changes in CVD morbidity and mortality.", "To determine whether a community based coronary heart disease health promotion project, undertaken over four years, was associated with changes in the prevalence in adults of lifestyle risk factors known to affect the development of coronary heart disease, and to estimate whether such an approach was cost effective.\n Prospective, comparative study of the effects of a health promotion intervention on coronary heart disease lifestyle risk factors, assessed by postal questionnaire sent to a randomly chosen sample, both at baseline and after four years.\n Intervention and control populations of adults aged 18-64 in Rotherham, both from areas with a high incidence of coronary heart disease and similar socioeconomic composition.\n Changes in prevalence of lifestyle risk factors between the control and intervention communities from 1991 to 1995. The effect of the intervention on certain lifestyle behaviours was evaluated using multiple logistic regression to model the proportion with a particular behaviour in the study communities as a function of age (18-40 or 41-64 years), sex, the year of observation (1991 or 1995), and area (intervention of control).\n 6.9% fewer people smoked and 8.7% more drank low fat milk in the intervention area, but no other statistically significant changes between the areas were detected. The estimated cost per life year gained was pounds 31.\n It is possible to have a cost effective impact on coronary heart disease lifestyle risk factors in a population of adults over four years using only modest resources.", "A community-based project for the prevention of cardiovascular diseases was undertaken in 1989 in a rural Danish municipality (Slangerup) with about 8000 inhabitants. Project goals were to draw attention to project activities and improve smoking, eating and exercise behaviours. The intervention was planned using the social learning theory, a communication-behaviour change model and community organisation principle. The strategy used for intervention involved both mass communication and active involvement of the local population in group activities. The objectives of the intervention were assessed by data obtained from representative cross-section surveys in intervention and a control area at baseline (1989) and one year later. More respondents in the intervention (82%) than control (67%) area were aware of local health projects. Ten % reported that they stopped smoking within the last year, 39% ate less fat, and 28% did more exercise, with no differences between intervention and control area. Several explanations are proposed for the limited effect of the project on behaviours. One possible explanation is that the project almost ended up being a pure mass media campaign which may increase awareness, but, as experience shows, may have limited influence on adoption of new behaviour. The Danish population around 1990 is very well informed and educated in this field due to earlier nationwide interventions. No further behavioural effects are obtainable with mass media campaigns.", "The Alliance of Black Churches Health Project was begun in an effort to address the health problems of the African-American residents of two rural Virginia counties. Smoking cessation was chosen as the principal target behavior in one county. Church coalitions were chosen as the principal organizations through which to implement the interventions.\n A smoking cessation program was designed that combined one-on-one counseling with self-help materials and community-wide activities. To provide these services, up to two smoking cessation counselors were trained from participating churches. To evaluate the impact, population-based cohorts of smokers were assembled in each county using a door-to-door survey. Respondents were recontacted after 18 months. Smoking cessation (1-month continuous abstinence), stages of change, and exposure to the interventions were assessed.\n The overall smoking prevalence at baseline was 25.8%. At follow-up, the smoking cessation rate in the intervention county was 9.6% and in the control county 5.4% (P = 0.18). Among those attending church once a month or more, the respective quit rates were 10.5% and 5.9% (P = 0.20). There was significantly more progress along the stages of change in the intervention than in the control county. There was also higher awareness of and contact with smoking cessation programs in the former compared with the latter.\n Smoking cessation interventions for African Americans can be successfully implemented through a church coalition. The interventions were associated with significant progress along the stages of cessation. Although the quit rate was higher in the intervention community, the difference was not significant.", "The Coronary Risk Factor Study (CORIS) examined the feasibility and effectiveness of a multifactorial community intervention programme to reduce coronary heart disease (CHD) risk factor levels. Three Afrikaner communities were surveyed before and after a 4-year intervention in two of the communities, the third serving as a control (C). Intervention was primarily by small mass media (low-intensity intervention, LII) or by small mass media plus interpersonal intervention to high-risk individuals (high-intensity intervention, HII). After allowing for change in C, significant net reductions in blood pressure, smoking, and risk score were obtained in LII and HII alike. Though the total cholesterol (TC) fell by 10-12%, there was no net reduction in favour of the intervention communities. However, LII and HII resulted in significant increases in high-density lipoprotein cholesterol (HDL-C) levels and HDL-C/TC ratios in comparison to C. Overall, the LII community fared almost as well as the HII community, and high-risk individuals did not show a greater change in risk factors than others. We conclude that community-based intervention works, and that in these particular communities a media-based health education programme was more cost-effective than one which adds a greater degree of interpersonal intervention.", "In a study on 'Assessment of Efficacy of an Anti-Tobacco Community Education Program' on Kolar District of Karnataka, India, an experimental and two control areas were chosen based on comparable population, health, and socioeconomic parameters. The two main objectives were to prevent individuals from taking up the tobacco habit among those who currently did not smoke or chew tobacco, and to stop the tobacco habit in those who did smoke or chew tobacco. A baseline tobacco-habit survey of the population was followed by anti-tobacco education of the community in the experimental area only. Two years later, a repeat survey of the population was conducted, followed by a final survey after a further three years. Methods of health education of the community included screening of films, exhibits, and personal contact with a display of photographs of the harmful effects of tobacco. The results were evaluated through changes in prevalence rates, quitters' rates, and initiation rate. The final survey showed that in the experimental area, the decline in the prevalence rate in the combined sample compared with the baseline rates was 10.2 percent in males and 16.3 percent in females, with a corresponding quitter's rate of 26.5 percent in males and 36.7 percent in females. Among men, a higher proportion (30.2 percent) had given up chewing compared with smoking (20.4 percent).", "BACKGROUDd. Smoking-related disease and injury is prominent among the numerous health problems on the U.S.-Mexico border, but little is known about the methods that might help promote smoking cessation among the low-income populations in this region.\n Media campaigns were combined with different forms of intensive and community-wide interpersonal communication to encourage smoking cessation in a border U.S. city and in a Mexican city. Panels of moderate to heavy smokers were followed in four groups to allow quasi-experimental comparison of smoking cessation rates.\n Over a five-year study period smoking cessation rates of 17% (self-reported) and 8% (verified) were observed in panels in the program community (N = 160). In the comparison community (N = 135) corresponding rates of smoking cessation were 7% (self-reported) and 1.5% (verified). Within the program community, no differences were observed in smoking cessation among smokers exposed to a community-wide program and those assigned to receive personal counseling.\n Although the observed changes in smoking were unexpectedly small in the treatment and comparison groups, the approximately 8% effect size for the community-wide program was close to what was predicted. Results indicate that such programs may yield effects similar to those of more intensive approaches, but further research with greater statistical power will be necessary to confirm that point.", "To determine the effects of 5 years of community-wide cardiovascular health education on smoking prevalence and cessation, the authors analyzed data from the Stanford Five-City Project, an experimental field study with two treatment cities and two control cities. Representative samples of the population aged 12-74 years were drawn at baseline and every 2 years thereafter to obtain four independent cross-sectional surveys; participants aged 25-74 years are included in this paper (n approximately 440 per city per survey; total n = 6,981). The baseline sample was asked to return to three follow-up surveys, also 2 years apart, and those that did (n = 805) constitute the cohort survey sample. Self-reported cigarette smoking was confirmed by plasma thiocyanate and expired-air carbon monoxide levels. Smoking prevalence decreased over time in all cities, but in the cohort the decrease tended to be greater in treatment than in control cities (p = 0.10, two-tailed); the treatment-control difference was consistent over time (-1.51 percentage points/year in treatment vs. -0.78 percentage points/year in control, p = 0.007, two-tailed). In contrast, smoking prevalence in the independent samples declined similarly in treatment and control cities, changes were not linear, and rates varied within cities between times. Baseline smokers in both the cohort and the follow-up independent surveys were significantly more likely to quit in the treatment cities than in the control cities.", "Whether community-wide education changed cardiovascular risk factors and disease risk in Pawtucket, RI, relative to a comparison community was assessed.\n Random-sample, cross-sectional surveys were done of people aged 18 through 64 years at baseline, during, and after education. Baseline cohorts were reexamined. Pawtucket citizens of all ages participated in multilevel education, screening, and counseling programs.\n The downward trend in smoking was slightly greater in the comparison city. Small, insignificant differences favored Pawtucket in blood cholesterol and blood pressure. In the cross-sectional surveys, body mass index increased significantly in the comparison community; a similar change was not seen in cohort surveys. Projected cardiovascular disease rates were significantly (16%) less in Pawtucket during the education program. This difference lessened to 8% posteducation.\n The hypothesis that projected cardiovascular disease risk can be altered by community-based education gains limited support from these data. Achieving cardiovascular risk reduction at the community level was feasible, but maintaining statistically significant differences between cities was not. Accelerating risk factor changes will likely require a sustained community effort with reinforcement from state, regional, and national policies and programs.", "To present an evaluation of a 5-year, community-based, chronic disease prevention project managed by a state health department to determine whether the department could replicate similar previous projects that had received more funding and other resources.\n The evaluation used a matched comparison design and a review of archive and interview data.\n Florence, South Carolina (population: 56,240).\n A random sample of 1642 persons in Florence (and 1551 in the comparison) who responded to a risk factor questionnaire and underwent a physical assessment; 70.7% of baseline subjects participated in the postintervention. Forty key persons were interviewed concerning project effectiveness. INTERVENTIONS BY PROJECT: Walk-a-thons, a speakers' bureau, media messages, restaurant food labeling, and cooking seminars. More than 31,000 participants were involved in 585 activities.\n Questionnaires focused on hypertension, obesity, high cholesterol, smoking, and exercise. Physical assessments determined lipid, lipoprotein, apolipoprotein, and blood pressure levels. Analysis of covariance was used for baseline and postintervention comparisons. Content analysis was used on archive and interview data.\n The project had a slightly favorable intervention effect on cholesterol and smoking, but failed to have an effect on other risk factors for cardiovascular disease. The project influenced community awareness, enlisted influential community members, and fostered linkages among local health services.\n Health departments can be instrumental in community risk reduction programming; however, they may not replicate projects having greater resources.", "In six regions of former West Germany, a community-oriented prevention program for coronary heart disease (CHD) was conducted over a 7-year period.\n In the intervention regions, CHD prevention activities were performed with special emphasis on healthy nutrition, increased physical activity, and reduction of smoking, hypertension, and hypercholesterolemia. The impact of these activities on CHD risk factor trends was observed in three independent samples of the intervention regions. Three independent representative samples of the total West German population were used as a reference. Linear regression models with interaction terms to represent the intervention effects were used to test for differences in risk factor trends.\n In the pooled intervention regions, a net reduction in mean values of systolic (-2.0%) and diastolic (-2.0%) blood pressure, total serum cholesterol (-1.8%), as well as the percentage of smokers (-6.7%) was observed compared with the nationwide trend. From the major CHD risk factors, only body mass index was not influenced in the intervention population.\n The community-oriented German Cardiovascular Prevention program can effectively be used to reduce CHD risk factors in a broad population.", "The study describes changes in cardiovascular risk factors during 10 years of a community intervention program conducted in a rural area in Central Italy. Two areas were involved, one for treatment and one for reference. In 1983-84, 739 men and 859 women in the treatment area and 942 men and 1045 women in the control area, aged 20-69 years, were screened; total and HDL cholesterol, systolic and diastolic blood pressure, fasting blood glucose, smoking habit, weight and height were measured. Between 1983 and 1993 several intervention activities based on community medicine were carried out in the treatment area. They were based on interaction with the local socio-sanitary institutions and school system in order to influence individual persons, small groups and entire community. Major effort was addressed to mass health education, nutrition education, antismoking-propaganda and detection and treatment of hypertension, diabetes and hyperlipidemia.", "This article describes one outcome of a randomized controlled trial of community action for cancer prevention. The aims of this article were to (a) explore the effectiveness of a community action program in decreasing community smoking rates in rural Australian towns and (b) describe the relationship between adult smoking quit and uptake rates and demographic variables.\n In 1992, 20 towns were selected for randomization. Community action involved formation of community committees and utilization of access point networks to initiate and maintain intervention strategies. At post-test, outcomes were proportion of \"quitters\" from a cohort of self-described smokers, proportion of \"uptakers\" from a cohort of self-described nonsmokers, and \"net effect.\"\n Differences in quit rate, uptake rate, and net effect for intervention compared to control condition favored the intervention in all cases, although mainly nonsignificant. Significantly more male smokers quit in intervention towns than in control towns [7.0% (95% CI: 0.6, 13.5)].\n Given that CART utilized and improved upon strategies argued as effective in the literature, the limited success of the project in reducing adult smoking, considered in combination with COMMIT findings, suggests the need for further innovation in the field.\n Copyright American Health Foundation and Academic Press.", "This study evaluated the impact of a 4-year, community-based cardiovascular disease prevention program among adults aged 18 to 65 years living in St-Henri, a low-income, innercity neighborhood in Montreal, Quebec.\n Awareness of and participation in the program were monitored in 3 independent sample telephone surveys. Self-reported behaviors were compared in St-Henri and a nearby comparison community before and after program implementation in both a 3-year repeat independent sample survey and a 5-year longitudinal cohort telephone survey.\n Awareness of the program reached 37.4%, but participation was low (2%-3%). There were no secular declines in smoking or high-fat diet; physical inactivity increased in both communities. There were no statistically significant program effects detected in the independent sample surveys, although physical inactivity increased more in the comparison community than in St-Henri. In the longitudinal cohort sample, there was a small, statistically significant increase favoring St-Henri in frequency of cholesterol checkups.\n Despite careful adaptation of the program to the local social context, there were few community-wide program effects. However, several component interventions showed promise in terms of community penetration and impact.", "The purpose of this study was to determine whether a community-based risk reduction project affected behavioral risk factors for cardiovascular disease.\n Community-based activities (e.g., exercise groups, healthy cooking demonstrations, blood pressure and cholesterol screenings, and cardiovascular disease education) were conducted in six southeastern Missouri counties. Evaluation involved population-based, cross-sectional samples of adult residents of the state and the intervention region. Weighted prevalence estimates were calculated for self-reported physical inactivity, cigarette smoking, consumption of fruits and vegetables, overweight, and cholesterol screening.\n Physical inactivity decreased within the intervention region, that is, in communities where heart health coalitions were developed and among respondents who were aware of these coalitions. In addition, the prevalence rates for reports of cholesterol screening within the past 2 years were higher for respondents in areas with coalitions and among persons who were aware of the coalitions.\n Even with modest resources, community-based interventions show promise in reducing self-reported risk for cardiovascular disease within a relatively brief period.", "To assess the net 5 year effects of intervention of a community based demonstration project, the Heartbeat Wales programme, on modifiable behavioural risks for prevention of cardiovascular disease.\n Quasi-experimental design comparing results from two independent cross sectional population surveys conducted in 1985 and 1990 in Wales and a matched reference area in north east England.\n Random, stratified samples of people aged 18-64 years (18,538 in 1985 and 13,045 in 1990) in Wales and in north east England (1483 and 4534, respectively).\n A coordinated range of activities for heart health promotion in Wales entailing public education campaigns along with supportive policy and infrastructure change. In the reference area no additional community heart health promotion was planned, though considerable activity did take place, \"contaminating\" the reference area.\n Fifteen self reported behavioural indicators relating to dietary choice, smoking, frequency of exercise, and weight.\n Positive changes (for health) in behavioural outcomes were observed among the population in Wales, including a reduction in reported smoking prevalence and improvements in dietary choice. There was no net intervention effect for the programme over and above observed change in the reference area.\n No definite conclusions can be drawn concerning the efficacy of the programme in terms of behavioural outcomes. With hindsight, the difficulties of evaluating such a complex multifaceted intervention were underestimated. Further debate on the most appropriate methods for assessing the effectiveness of community based health promotion programmes is called for." ]

[ "15645628", "18427089", "9846260" ]

[ "Cost-effectiveness and benefit of alternatives to improve training for prehospital trauma care in Mexico.", "The OPALS Major Trauma Study: impact of advanced life-support on survival and morbidity.", "The costs and benefits of paramedic skills in pre-hospital trauma care." ]

[ "In Latin America, there is a preponderance of prehospital trauma deaths. However, scarce resources mandate that any improvements in prehospital medical care must be cost-effective. This study sought to evaluate the cost-effectiveness of several approaches to improving training for personnel in three ambulance services in Mexico.\n In Monterrey, training was augmented with PreHospital Trauma Life Support (PHTLS) at a cost of [US] dollar 150 per medic trained. In San Pedro, training was augmented with Basic Trauma Life Support (BTLS), Advanced Cardiac Life Support (ACLS), and a locally designed airway management course, at a cost of dollar 400 per medic. Process and outcome of trauma care were assessed before and after the training of these medics and at a control site.\n The training was effective for both intervention services, with increases in basic airway maneuvers for patients in respiratory distress in Monterrey (16% before versus 39% after) and San Pedro (14% versus 64%). The role of endotrachal intubation for patients with respiratory distress increased only in San Pedro (5% versus 46%), in which the most intensive Advanced Life Support (ALS) training had been provided. However, mortality decreased only in Monterrey, where it had been the highest (8.2% before versus 4.7% after) and where the simplest and lowest cost interventions were implemented. There was no change in process or outcome in the control site.\n This study highlights the importance of assuring uniform, basic training for all prehospital providers. This is a more cost-effective approach than is higher-cost ALS training for improving prehospital trauma care in environments such as Latin America.", "To date, the benefit of prehospital advanced life-support programs on trauma-related mortality and morbidity has not been established\n The Ontario Prehospital Advanced Life Support (OPALS) Major Trauma Study was a before-after systemwide controlled clinical trial conducted in 17 cities. We enrolled adult patients who had experienced major trauma in a basic life-support phase and a subsequent advanced life-support phase (during which paramedics were able to perform endotracheal intubation and administer fluids and drugs intravenously). The primary outcome was survival to hospital discharge.\n Among the 2867 patients enrolled in the basic life-support (n = 1373) and advanced life-support (n = 1494) phases, characteristics were similar, including mean age (44.8 v. 47.5 years), frequency of blunt injury (92.0% v. 91.4%), median injury severity score (24 v. 22) and percentage of patients with Glasgow Coma Scale score less than 9 (27.2% v. 22.1%). Survival did not differ overall (81.1% among patients in the advanced life-support phase v. 81.8% among those in the basic life-support phase; p = 0.65). Among patients with Glasgow Coma Scale score less than 9, survival was lower among those in the advanced life-support phase (50.9% v. 60.0%; p = 0.02). The adjusted odds of death for the advanced life-support v. basic life-support phases were nonsignificant (1.2, 95% confidence interval 0.9-1.7; p = 0.16).\n The OPALS Major Trauma Study showed that systemwide implementation of full advanced life-support programs did not decrease mortality or morbidity for major trauma patients. We also found that during the advanced life-support phase, mortality was greater among patients with Glasgow Coma Scale scores less than 9. We believe that emergency medical services should carefully re-evaluate the indications for and application of prehospital advanced life-support measures for patients who have experienced major trauma.", "nan" ]

[ "18759805", "14693355" ]

[ "What works for whom in a computer-mediated communication intervention in community psychiatry? Moderators of outcome in a cluster randomized trial.", "A low-cost, telephone intervention to enhance schizophrenia treatment: a demonstration study." ]

[ "An intervention to structure patient-key worker communication has been tested in a randomized controlled trial. The aim of this paper was to investigate effectiveness of the intervention in terms of moderators of effectiveness.\n A total of 507 patients with schizophrenia were included. Moderators of effectiveness were investigated using two-way anovas.\n Patients with a better relationship with their key worker and a shorter duration of illness at baseline benefited more from the intervention in terms of quality of life. Patients who received the intervention who were in competitive employment or had a shorter duration of illness showed greater reduction of unmet needs. Older patients receiving the intervention had better treatment satisfaction.\n Outcome of the intervention was moderated by patient characteristics. Moreover, the moderating characteristics varied depending on the specific outcome. Evidence on moderators is very limited, even though, they are significant for understanding, targeting and implementing complex interventions.", "nan" ]

[ "2646536", "8409069", "2144803", "2503017", "7901256", "6188895", "7038483", "2447297", "7051826", "8505940" ]

[ "A comparison of oral milrinone, digoxin, and their combination in the treatment of patients with chronic heart failure.", "Randomized study assessing the effect of digoxin withdrawal in patients with mild to moderate chronic congestive heart failure: results of the PROVED trial. PROVED Investigative Group.", "Exercise capacity and quality of life in the treatment of heart failure.", "Clinical, haemodynamic, and pharmacological effects of withdrawal and reintroduction of digoxin in patients with heart failure in sinus rhythm after long term treatment.", "Double-blind placebo-controlled study of ibopamine and digoxin in patients with mild to moderate heart failure: results of the Dutch Ibopamine Multicenter Trial (DIMT).", "Digoxin withdrawal after cardiac failure in patients with sinus rhythm.", "Heart failure in outpatients: a randomized trial of digoxin versus placebo.", "Comparative effects of therapy with captopril and digoxin in patients with mild to moderate heart failure. The Captopril-Digoxin Multicenter Research Group.", "Is digoxin really important in treatment of compensated heart failure? A placebo-controlled crossover study in patients with sinus rhythm.", "Withdrawal of digoxin from patients with chronic heart failure treated with angiotensin-converting-enzyme inhibitors. RADIANCE Study." ]

[ "We randomly assigned 230 patients in sinus rhythm with moderately severe heart failure to treatment with digoxin, milrinone, both, or placebo. The effects of each were compared during a 12-week, double-blind trial. Treatment with milrinone or digoxin significantly increased treadmill exercise time as compared with placebo (by 82 and 64 seconds respectively; 95 percent confidence limits, 44 and 123, and 30 and 100). Both treatments reduced the frequency of decompensation from heart failure, from 47 percent with placebo to 34 percent with milrinone (P less than 0.05; 95 percent confidence limits, 22 and 46) and 15 percent with digoxin (P less than 0.01; 95 percent confidence limits, 7 and 26). However, the clinical condition of 20 percent of the patients taking milrinone deteriorated within two weeks after treatment was begun, as compared with only 3 percent of those taking digoxin (P less than 0.05). The left ventricular ejection fraction at rest was not significantly changed by milrinone (+0.2 percent; 95 percent confidence limits, -1.5 and 1.9), but it was increased by digoxin (+1.7 percent; P less than 0.01; 95 percent confidence limits, -0.03 and 3.4) and decreased by placebo (-2.0 percent; 95 percent confidence limits, -3.8 and -0.1). Three-month survival was related inversely to the base-line ejection fraction. Analysis of mortality from all causes according to the intention to treat suggested an adverse effect of milrinone (P = 0.064). After adjustment for an excess of patients with lower ejection fractions randomly assigned to receive milrinone, this trend was not significant (P = 0.26). Increased ventricular arrhythmias occurred more frequently in patients who received milrinone than in those who did not (18 vs. 4 percent; P less than 0.03). We conclude that milrinone significantly increased exercise tolerance and reduced the frequency of worsened heart failure. However, in the population of patients studied, milrinone or the combination of milrinone and digoxin offered no advantage over digoxin alone. Furthermore, our data suggest that milrinone may aggravate ventricular arrhythmias.", "The purpose of this study was to determine whether digoxin is effective in patients with chronic, stable mild to moderate heart failure.\n Digoxin has been a traditional therapy in heart failure, but methodologic limitations in earlier studies have prevented definitive conclusions regarding its efficacy.\n Withdrawal of digoxin (placebo group, n = 46) or its continuation (digoxin group, n = 42) was performed in a prospective, randomized, double-blind, placebo-controlled multicenter trial of patients with chronic, stable mild to moderate heart failure secondary to left ventricular systolic dysfunction who had normal sinus rhythm and were receiving long-term treatment with diuretic drugs and digoxin.\n Patients withdrawn from digoxin therapy showed worsened maximal exercise capacity (median change in exercise time -96 s) compared with that of patients who continued to receive digoxin (change in exercise time +4.5 s) (p = 0.003). Patients withdrawn from digoxin therapy showed an increased incidence of treatment failures (p = 0.039) (39%, digoxin withdrawal group vs. 19%, digoxin maintenance group) and a decreased time to treatment failure (p = 0.037). In addition, patients who continued to receive digoxin had a lower body weight (p = 0.044) and heart rate (p = 0.003) and a higher left ventricular ejection fraction (p = 0.016).\n These data provide strong evidence of the clinical efficacy of digoxin in patients with normal sinus rhythm and mild to moderate chronic heart failure secondary to systolic dysfunction who are treated with diuretics.", "In a double-blind study comparing two active treatments (digoxin and xamoterol) and placebo in patients with heart failure, improvements in exercise capacity and quality of life were observed in all three groups, with no significant differences. The substantial benefits seen in the placebo group were probably the result of increased attention from the medical and research staff and suggest the therapeutic value of special heart failure clinics. The relationship between exercise and symptomatic/functional status has been unclear. We developed quantitative measures of quality-of-life variables and examined their relationship with exercise capacity. There were significant relationships between change in exercise duration and changes in breathlessness, tiredness, chest pain, walking difficulty, rate of walking, difficulty with daily tasks, speed of daily tasks, mood, and sleeping. This study confirms the validity of measuring change in exercise capacity and demonstrates that specific measurements of quality of life make an important contribution to the evaluation of the treatment of heart failure.", "A randomised, double blind, placebo controlled, crossover study of digoxin withdrawal and reintroduction was carried out over two periods of eight weeks each after long term treatment. Forty four patients with stable heart failure in sinus rhythm and plasma digoxin concentrations over 0.8 ng/ml were studied. Their progress was assessed by clinical criteria, by haemodynamic measurements (systolic time intervals and echocardiography), and by pharmacological measurements of erythrocytic sodium pump numbers and activity. After withdrawal of digoxin clinical deterioration occurred in only 25% of the patients. Furthermore, in only 9% of cases was digoxin reintroduction thought to be necessary. There was deterioration in only 11% of the patients during digoxin treatment. Deterioration during digoxin withdrawal was accompanied by changes in systolic time intervals, but similar, albeit smaller changes in systolic time intervals also occurred in patients with no deterioration. Deterioration was accompanied by changes in the pharmacological effects of digoxin on the erythrocytes, consistent with a loss of effect, and these changes did not occur in those who did not deteriorate. The occurrence of deterioration could not be predicted by any clinical, haemodynamic, or pharmacological measurements made before withdrawal.", "This study was conducted to determine the efficacy and safety of long-term treatment with the orally active dopamine agonist ibopamine in patients with mild to moderate chronic congestive heart failure and to compare the results with those of treatment with digoxin and placebo.\n Ibopamine and digoxin are drugs that exert hemodynamic and neurohumoral effects. Because there is accumulating evidence that progression of disease in chronic heart failure is related not only to hemodynamic but also to neurohumoral factors, both drugs might be expected to have a favorable long-term effect.\n We studied 161 patients with mild to moderate chronic heart failure (80% in New York Heart Association functional class II and 20% in class III), who were treated with ibopamine (n = 53), digoxin (n = 55) or placebo (n = 53) for 6 months. Background therapy consisted of furosemide (0 to 80 mg); all other drugs for heart failure were excluded. Clinical assessments were made at baseline and after 1, 3 and 6 months.\n Of the 161 patients, 128 (80%) completed the study. Compared with placebo, digoxin but not ibopamine significantly increased exercise time after 6 months (p = 0.008 by intention to treat analysis). Ibopamine was only effective in patients with relatively preserved left ventricular function, as it significantly increased exercise time in this subgroup (for patients with a left ventricular ejection fraction > 0.30; p = 0.018 vs. placebo). No patient receiving digoxin withdrew from the study because of progression of heart failure, compared with six patients receiving ibopamine and two receiving placebo. At 6 months, plasma norepinephrine was decreased with digoxin and ibopamine therapy (-106 and -13 pg/ml, respectively) but increased with placebo administration (+62 pg/ml) (both p < 0.05 vs. placebo). Plasma aldosterone was unaffected, but renin was decreased by both agents after 6 months (p < 0.05 vs. placebo). Total mortality and ambulatory arrhythmias were not significantly affected by the two drugs.\n Ibopamine and digoxin both inhibit neurohumoral activation in patients with mild to moderate chronic heart failure. However, the clinical effects of these drugs are different and appear to be related to the degree of left ventricular dysfunction.", "A double-blind placebo-controlled crossover trial of digoxin withdrawal was undertaken in 22 patients with sinus rhythm who had a previous history of frank heart failure and were taking therapeutic doses of the drug. During the course of the study, 14 patients showed no clinical change whether taking digoxin or placebo, five patients deteriorated on placebo (four with heart failure and one with supraventricular tachycardia), and three on digoxin (two with heart failure and one with digoxin toxicity). These differences were not statistically significant. Compared to placebo, patients, while taking digoxin, had lower resting heart rates and significant shortening of all the systolic time intervals. The drug appears to exert a sustained positive inotropic effect during maintenance therapy, but this is not of clinical benefit to the majority of patients.", "The view that digitalis clinically benefits patients with heart failure and sinus rhythm lacks support from a well-controlled study. Using a randomized, double-blind, crossover protocol, we compared the effects of oral digoxin and placebo on the clinical courses of 25 outpatients without atrial fibrillation. According to a clinicoradiographic scoring system, the severity of heart failure was reduced by digoxin in 14 patients; in nine of these 14, improvement was confirmed by repeated trials (five patients) or right-heart catheterization (four patients). The other 11 patients had no detectable improvement from digoxin. Patients who responded to digoxin had more chronic and more severe heart failure, greater left ventricular dilation and ejection-fraction depression, and a third heart sound. Multivariate analysis showed that the third heart sound was the strongest correlate of the response to digoxin (P less than 0.0001). These data suggest that long-term digoxin therapy is clinically beneficial in patients with heart failure unaccompanied by atrial fibrillation whose failure persists despite diuretic treatment and who have a third heart sound.", "This multicenter, double-blind, placebo-controlled study compares the effects of captopril treatment with those of digoxin treatment during maintenance diuretic therapy in patients with mild to moderate heart failure. Compared with placebo, captopril therapy resulted in significantly improved exercise time (mean increase, 82 s vs 35 s) and improved New York Heart Association class (41% vs 22%), but digoxin therapy did not. Digoxin treatment increased ejection fraction (4.4% increase) compared with captopril therapy (1.8% increase) and placebo (0.9% increase). The number of ventricular premature beats decreased 45% in the captopril group and increased 4% in the digoxin group in patients with more than ten ventricular premature beats per hour. Treatment failures, increased requirements for diuretic therapy, and hospitalizations were significantly more frequent in patients receiving placebo compared with those receiving either active drug. Transitory hypotension occurred more frequently with administration of captopril. Captopril treatment is significantly more effective than placebo and is an alternative to digoxin therapy in patients with mild to moderate heart failure who are receiving diuretic maintenance therapy.", "To assess the efficacy of digitalis in patients with chronic clinically compensated congestive heart failure and normal sinus rhythm, we performed a double-blind crossover study with digoxin and placebo in 30 consecutive outpatients fulfilling these criteria; serum digoxin levels, clinical symptoms and signs, and objective indexes of cardiac function were monitored. No patient's clinical condition deteriorated during three months of placebo administration. Discontinuation of digoxin resulted in a small increase in echocardiographically determined resting left ventricular end-diastolic dimension (1.8 +/- 0.6 mm, p less than 0.001) and a similar decrease in velocity of circumferential fiber shortening (-0.08 +/- 0.04 circ/sec, p less than 0.05) from the corresponding values of 55.8 +/- 2.3 mm and 0.90 +/- 0.08 circ/sec during digitalis therapy. Resting left ventricular ejection time and pre-ejection period were prolonged by digoxin withdrawal. Maximal exercise capacity was unchanged. No clinical exacerbation of heart failure attributable to digitalis withdrawal occurred over a follow-up period averaging 19 months. The results indicate that long-term digoxin therapy has only a minor effect on cardiac performance that is without apparent clinical importance in a representative population of ambulatory patients treated with cardiac glycosides.", "Although digoxin is effective in the treatment of patients with chronic heart failure who are receiving diuretic agents, it is not clear whether the drug has a role when patients are receiving angiotensin-converting-enzyme inhibitors, as is often the case in current practice.\n We studied 178 patients with New York Heart Association class II or III heart failure and left ventricular ejection fractions of 35 percent or less in normal sinus rhythm who were clinically stable while receiving digoxin, diuretics, and an angiotensin-converting-enzyme inhibitor (captopril or enalapril). The patients were randomly assigned in a double-blind fashion either to continue receiving digoxin (85 patients) or to be switched to placebo (93 patients) for 12 weeks. Otherwise, their medical therapy for heart failure was not changed.\n Worsening heart failure necessitating withdrawal from the study developed in 23 patients switched to placebo, but in only 4 patients who continued to receive digoxin (P < 0.001). The relative risk of worsening heart failure in the placebo group as compared with the digoxin group was 5.9 (95 percent confidence interval, 2.1 to 17.2). All measures of functional capacity deteriorated in the patients receiving placebo as compared with those continuing to receive digoxin (P = 0.033 for maximal exercise tolerance, P = 0.01 for submaximal exercise endurance, and P = 0.019 for New York Heart Association class). In addition, the patients switched from digoxin to placebo had lower quality-of-life scores (P = 0.04), decreased ejection fractions (P = 0.001), and increases in heart rate (P = 0.001) and body weight (P < 0.001).\n These findings indicate that the withdrawal of digoxin carries considerable risks for patients with chronic heart failure and impaired systolic function who have remained clinically stable while receiving digoxin and angiotensin-converting-enzyme inhibitors." ]

[ "11429939", "17340895", "12516643", "12685794", "14575630", "9104715", "11359306", "14536040", "17348883", "12175374", "11887655", "11938636", "17100744", "17224029", "11564104" ]

[ "Mandibular overdentures supported by two Brånemark, IMZ or ITI implants. A prospective comparative preliminary study: one-year results.", "Immediate loading of dental implants supporting fixed partial dentures in the posterior mandible: a randomized controlled split-mouth study--machined versus titanium oxide implant surface.", "Nonsubmerged and submerged implants in the treatment of the partially edentulous maxilla.", "Immediate loading of Brånemark implants: a 24-month follow-up of a comparative prospective pilot study between mandibular overdentures supported by Conical transmucosal and standard MK II implants.", "Early functional loading of unsplinted roughened surface implants with mandibular overdentures 2 weeks after surgery.", "A comparative prospective clinical study of two single-tooth implants: a preliminary report of 102 implants.", "Astra Tech and Brånemark System implants: a prospective 5-year comparative study. Results after one year.", "One-year prospective three-center study comparing the outcome of a \"soft bone implant\" (prototype Mk IV) and the standard Brånemark implant.", "Immediate implant placement with transmucosal healing in areas of aesthetic priority. A multicentre randomized-controlled clinical trial I. Surgical outcomes.", "Two-stage IMZ implants and ITI implants inserted in a single-stage procedure. A prospective comparative study.", "One-stage operative procedure using two different implant systems: a prospective study on implant overdentures in the edentulous mandible.", "Early loading of unsplinted implants supporting mandibular overdentures using a one-stage operative procedure with two different implant systems: a 2-year report.", "Immediate loading of Brånemark System Implants: a comparison between TiUnite and turned implants placed in the anterior mandible.", "Fully vs. partially rough implants in maxillary sinus floor augmentation: a randomized-controlled clinical trial.", "Brånemark System and ITI Dental Implant System for treatment of mandibular edentulism. A comparative randomized study: 3-year follow-up." ]

[ "The aim of this prospective comparative study was to evaluate the condition of the peri-implant tissues of three different implant systems supporting a mandibular overdenture. Ninety edentulous patients (Cawood class V-VI) participated in this study. After randomization, 30 patients were treated with 2 Brånemark implants, 30 patients with 2 IMZ implants and 30 patients with 2 ITI implants. The implants were inserted in the canine region of the mandible. After 3 months overdentures were fabricated supported by a round bar and clip attachment. A standardized clinical and radiographic evaluation was performed 0,6 and 12 months after insertion of the denture. The intraoral radiographs were made, using the long-cone technique with an aiming device. Two implants were lost (1 Brånemark, 1 IMZ) during the healing period. None of the patients showed any sensory change in lip or chin region. The pocket depth in the Brånemark group decreased significantly whereas the mucosa recession increased significantly in both the Brånemark as well as in the IMZ group. After 12 months, there was significantly less bone loss in the ITI group. From our study it was concluded that 2 (Brånemark, IMZ or ITI) implants placed in the interforaminal region connected with a bar supply a proper base for the support of a mandibular overdenture in the (Cawood V-VI) edentulous patient. The ITI implant appears to be the implant of choice for mandibular overdenture therapy, because only one operation is required for a comparable result.", "A split-mouth study was conducted to compare dental implants with either machined or titanium oxide (TiO) surfaces immediately loaded with fixed partial dentures in the posterior mandible.\n Ten patients with bilateral partial edentulism in the posterior mandible received 42 implants; 20 on the test (TiO) and 22 on the control (machined) side. The implants were loaded within 24 hours postsurgery. At implant placement the maximum insertion torque (IT) was recorded. Implant stability quotient (ISQ) was also evaluated at baseline (day 0) and 1, 2, 4, 12, 24, and 52 weeks following implant placement. The radiographic bone level (RBL) change was measured on periapical radiographs at baseline and 12 months after loading. Means for the 2 groups were compared by paired t test.\n The overall implant success rate was 95%. No implants were lost in the test group; 2 failed in the control group. The difference between the groups in RBL change after 1 year of function was not statistically significant (P = .224). However, average RBL change for machined implants in distal positions was significantly higher than for TiO surface implants in the same position (post-hoc comparison; P = .048). ISQ and peak IT values did not differ between the groups (P = .414 and P = .762, respectively). The high IT necessary to insert the implants did not seem to affect the RBL change (P = .203).\n No significant difference was observed between machined and TiO implant surface in terms of RBL change or ISQ, although TiO implants may provide a lower RBL change compared to machined implants when utilized in the distal position. Immediate loading of implants using fixed partial dentures in posterior mandible may be considered as a treatment option if implants are inserted with IT > or = 20 Ncm and ISQ > or = 60 into nonaugmented bone and loaded with light centric occlusal contact.", "Dental implants vary in design and surfaces. In addition, different surgical techniques have been used for implant insertion. The ITI Dental Implant System (Straumann AG, Waldenburg, Switzerland) has always required a one-stage technique, whereas the Brånemark System (Nobel Biocare AB, Gothenburg, Sweden) requires a two-stage technique.\n The aim of this study is to compare the outcome of fixed partial bridges in the maxilla supported by both ITI and Brånemark implants in a split-mouth design.\n Twenty-eight patients with a residual anterior dentition in the maxilla were included in this split-mouth study. The Brånemark implants were used on one side and the ITI implants on the other side of the residual dentition according to a randomization procedure. A blocking size of four was used, giving equal probability of placing ITI or Brånemark implants in the right or left side of the jaw. The surgical and prosthetic procedures followed the guidelines given by the manufacturers. The prosthetic treatment with the two-implant systems was performed at the same time, and for that reason the healing period was 6 months for both systems. The observation period for all patients was 1 year after loading.\n Two Brånemark implants (in one patient) were lost before loading, and one ITI implant was lost 1 year after loading. There was no significant difference in survival rate. Radiographic examination of the bone level was performed at the time of delivery of the bridge and after 1 year. The mean marginal bone level at baseline was situated 1.9 mm from the reference point for the Brånemark implants and 1.5 mm for the ITI implants. With regard to the insertion depth used, these bone levels indicate that bone loss had taken place before baseline. However, between baseline and the 1-year examination, there was no significant change of the marginal bone (0.2 +/- 0.08 mm at the Brånemark implants and 0.1 +/- 0.11 mm at the ITI implants). The difference between results with the two implants was not statistically significant. Crater-form bone destructions were seen at some ITI implants, indicating periimplantitis. However, at only two implants were there clinical signs of periimplantitis.\n No significant difference in survival rate or in marginal bone change could be demonstrated between the two systems. At some ITI implants (18%), crater-form bone loss was observed.", "The purpose of this prospective study is to compare the long-term outcome of immediately loaded implant-retained mandibular overdentures supported by four screw-type one-piece transmucosal implants with that of four screw-type two-piece implants inserted in the interforaminal area of the mandible and rigidly connected by a U-shaped curved\n A prospective pilot study was conducted with 10 patients receiving an implant-supported overdenture in the mandible. The patients were randomly assigned to two groups. In the control group (five patients), four standard Brånemark implants (MK II; Nobel Biocare AB, Gothenburg, Sweden), 3.75 mm large and at least 10 mm long, were sited anterior to the mental foramina, and four standard abutments (Nobel Biocare AB) for bar construction were immediately screwed to the implants. In the test group (five patients), four conical transmucosal implants (Nobel Biocare AB), 3.75 mm large and at least 9 mm long in the threaded part, were sited anterior to the mental foramina. Immediately after implant placement, a U-shaped gold or titanium bar was fabricated and implants were immediately loaded (within 24 h) in both groups with an implant-retained overdenture. The patients were followed up for a minimum of 24 months. Implants were evaluated at the time of immediate loading and at 12 and 24 months after prosthetic loading, with the following parameters: modified plaque index (MPI), modified bleeding index (MBI), and probing depth (PD). Periimplant bone resorption was evaluated on panoramic radiographs taken 12 and 24 months after the beginning of prosthetic loading.\n No significant differences were found between the two groups with regard to MPI, MBI, PD, and periimplant bone resorption at 12 and 24 months. The cumulative success rate of implants according to the criteria proposed by Albrektsson and colleagues was 100% in both groups after 2 years of functional loading.\n Results from this study demonstrated that the success rate for immediately loaded mandibular implants is similar to that obtained in cases of delayed loading and that there are no significant differences between results with two-piece implants and one-piece transmucosal implants.", "Before early functional loading of unsplinted implants with mandibular overdentures can become widespread, more clinical studies are needed to investigate the success of the approach.\n To evaluate the success rates of two types of roughened titanium surface implants with early 2-week functional loading of paired mandibular interforaminal implants with overdentures.\n Random allocation divided 24 strictly selected edentulous participants into two groups, with each group to receive a different implant system (ITI Dental Implant System, Straumann AG, Waldenburg, Switzerland; or Southern Implant System, Southern Implants, Irene, South Africa). Two implants were placed in the anterior mandible of all participants using one-stage standardized surgical procedures. Previously constructed conventional mandibular dentures (opposing maxillary complete dentures) were temporarily relined and worn by the participants for the first 2 weeks; participants used a soft diet. Two weeks after implant surgery and following some mucosal healing, the mandibular dentures had the tissue conditioner removed and the appropriate matrices included for an unsplinted prosthodontic design.\n No implant from either group was lost. Resonance frequency analysis (RFA) indicated higher primary stability at surgery for the Southern group than for the ITI group, with a statistically significant difference between the groups throughout the study period. The drop in RF values between surgery and 6 weeks was significant and was greater for the Southern group. RFA also indicated stabilized osseointegration between 6 to 12 and 12 to 52 weeks, with no participant showing any decrease in those values over time. Participants with type 3 bone showed a significant improvement in RF values between 12 and 52 weeks, eventually matching those of participants with type 2 bone. There were no significant differences in marginal bone loss, periimplant parameters, or prosthodontic maintenance between the groups over the study period.\n Using only strict patient selection criteria, 1-year follow-up data indicate that early functional loading of ITI and Southern implants with mandibular two-implant overdentures is possible as early as 2 weeks after implant surgery.", "Treatment of tooth loss in the anterior maxilla can involve difficult functional, esthetic, and psychologic problems, especially in young patients with otherwise good dentition.\n The purpose of this study was to provide a preliminary comparative evaluation of two implants (ITI and Astra) in single-tooth restorations.\n This prospective study of 102 single-tooth replacements with 56 ITI and 46 Astra dental implants was performed in 82 patients at the Finnish Student Health Service Foundation. One Astra implant was lost before loading. The overall survival rate of the implants was 97.8% for Astra implants and 100% for the ITI system. After the initial healing period of at least 6 months, the remaining 101 implants (56 ITI, 45 Astra) were free of periimplant infection and revealed no detectable mobility. Radiographs did not reveal signs of periimplant radiolucencies. All 101 implants received single-tooth crowns.\n Periimplant parameters and acceptable implant function were examined and demonstrated satisfactory results with preestablished clinical parameters and radiographs at 1 year. During the observation time the mean marginal bone loss was 0.13 mm with Astra implants and 0.11 mm with ITI implants. Subjectively all patients were satisfied with their single-tooth restorations supported by either ITI or Astra dental implants.\n The favorable results of this short-term study support the application of the two implant systems for single-tooth restorations, especially in the anterior region of the maxilla.", "Endosseous dental implants are used frequently, and many implant systems are available. The scientific documentation of the implant system presents a great variation, and it is often difficult to compare studies of different systems.\n The aim of this study was to compare two Swedish implant systems (Astra Tech and Brånemark System implants), in a prospective randomized study.\n Sixty-six patients were equally distributed between the two implant systems; 184 Astra Tech and 187 Brånemark System implants were used. The patients have been followed annually with clinical and radiographic examinations. The results after 1 year are reported.\n The abutment procedure was found to be easier and less time-consuming with Astra Tech than with Brånemark implants. The operation times in minutes (mean +/- SEM) were for the respective implant 35 +/- 4.0 and 51 +/- 4.8 in the maxilla and 32 +/- 3.8 and 43 +/- 2.4 in the mandible. The differences in both cases were significant: p < .02 and p < .05, respectively. The failure rate for Astra Tech implants was 0.5% and for Brånemark implants 4.3%. The difference was significant (p < .05); however, taking into account that five of the eight implant losses in the Brånemark implant group occurred in one patient, an intraindividual correlation cannot be excluded. Therefore, this result should be interpreted with caution. The marginal bone level changes were examined already from the fixture installation. The major bone loss was found between fixture installation and baseline. This bone loss was several times greater than the bone loss between the baseline and the 1-year follow-up. The total bone loss during the observation period did not differ significantly between the systems, but they had different resorption patterns. The bone loss in the upper jaw between baseline and 1-year follow-up was 0.22 +/- 0.14 and 0.03 +/- 0.09 mm for the Astra Tech and Brånemark implants, respectively. In the lower jaw, the loss was -0.31 for both systems. The frequency of plaque accumulation and bleeding on probing did not differ between the implant systems.\n Abutment connection with Astra Tech implants was simpler than the corresponding surgery with Brånemark System implants and the survival rate of Astra Tech implants was higher than that of Brånemark system implants.", "Oral implant treatment ad modum Brånemark has been used for decades in the rehabilitation of edentate and partially dentate patients. Posterior jaw regions frequently exhibit bone of poor texture, and it is often difficult to obtain primary stability. Thus, it may prove beneficial to deviate from the original protocol and to use implants with a modified design, for example, with a slightly tapered geometry.\n The purpose of the investigation was to compare the early behavior of a modified (prototype Mk IV, Brånemark System, Nobel Biocare AB, Gothenburg, Sweden; test) implant with that of the standard Brånemark implant (control) in regions of mainly type 4 bone.\n Three Swedish centers participated, and a total of 44 patients were treated with oral implants for 39 maxillas and 5 mandibles. The study focused on the most distal right and left implant sites (88 implants), which were randomized to receive either a test or a control implant. Various parameters were recorded, such as registered insertion torque (OsseoCare), Nobel Biocare AB), wobbling during insertion, primary and secondary stability (as measured with resonance frequency), and marginal bone loss. The implants were followed up for 1 year.\n The test implant more frequently required a higher insertion torque and showed a significantly higher primary stability than the control implant. This difference in stability leveled out over time, and test and control implants exhibited similar secondary stability at abutment operation and at the 1-year visit. Wobbling during insertion was rarely recorded for either of the implant designs. The 1-year cumulative success rate was 93.1% for test implants and 88.4% for control implants.\n The modified implant design resulted in an increased primary stability, which may be important when placing implants in jaw regions of type 4 bone. However, independent of the achieved primary stability, successful implants tended to approach similar secondary stability in the two designs tested.", "To compare the clinical outcomes of standard, cylindrical, screw-shaped to novel tapered, transmucosal (Straumann Dental implants immediately placed into extraction sockets. Material and methods: In this randomized-controlled clinical trial, outcomes were evaluated over a 3-year observation period. This report deals with the need for bone augmentation, healing events, implant stability and patient-centred outcomes up to 3 months only. Nine centres contributed a total of 208 immediate implant placements. All surgical and post-surgical procedures and the evaluation parameters were discussed with representatives of all centres during a calibration meeting. Following careful luxation of the designated tooth, allocation of the devices was randomly performed by a central study registrar. The allocated SLA titanium implant was installed at the bottom or in the palatal wall of the extraction socket until primary stability was reached. If the extraction socket was >or=1 mm larger than the implant, guided bone regeneration was performed simultaneously (Bio Oss and BioGide. The flaps were then sutured. During non-submerged transmucosal healing, everything was done to prevent infection. At surgery, the need for augmentation and the degree of wound closure was verified. Implant stability was assessed clinically and by means of resonance frequency analysis (RFA) at surgery and after 3 months. Wound healing was evaluated after 1, 2, 6 and 12 weeks post-operatively.\n The demographic data did not show any differences between the patients receiving either standard cylindrical or tapered implants. All implants yielded uneventful healing with 15% wound dehiscences after 1 week. After 2 weeks, 93%, after 6 weeks 96%, and after 12 weeks 100% of the flaps were closed. Ninety percent of both implant designs required bone augmentation. Immediately after implantation, RFA values were 55.8 and 56.7 and at 3 months 59.4 and 61.1 for cylindrical and tapered implants, respectively. Patient-centred outcomes did not differ between the two implant designs. However, a clear preference of the surgeon's perception for the appropriateness of the novel-tapered implant was evident.\n This RCT has demonstrated that tapered or standard cylindrical implants yielded clinically equivalent short-term outcomes after immediate implant placement into the extraction socket.", "The aim of this study was to evaluate the feasibility of using a two-stage implant system in a single-stage procedure and to study the impact of the microgap at crestal level and to monitor the microflora in the peri-implant area. Forty edentulous patients (Cawood & Howell class V-VI) participated in this study. After randomisation, 20 patients received two IMZ implants inserted in a single-stage procedure and 20 patients received two ITI implants. After 3 months, overdentures were fabricated, supported by a bar and clip attachment. A standardised clinical and radiographic evaluation was performed immediately after denture insertion and 6 and 12 months later. Twelve months after loading, peri-implant samples were collected with sterile paper points and analysed for the presence of putative periodontal pathogens using culture techniques. One IMZ implant was lost due to insufficient osseointegration. With regard to the clinical parameters at the 12 months evaluation, significant differences for plaque score and probing pocket depth (IMZ: mean 3.3 mm, ITI: mean 2.9 mm) were found between the two groups. The mean bone loss in the first year of functioning was 0.6 mm for both groups. Prevotella intermedia was detected more often in the ITI group (12 implants) than in the IMZ group (three implants). Porphyromonas gingivalis was found in three patients. In one of these patients an implant showed bone loss of 1.6 mm between T0 and T12. Some associations were found between clinical parameters and the target microorganisms in the ITI group. These associations were not present in the IMZ group. The short-term results indicate that two-stage implants inserted in a single-stage procedure may be as predictable as one-stage implants. The microgap at crestal level in nonsubmerged IMZ implants seems to have no adverse influence on the peri-implant microbiological colonisation and of crestal bone loss in the first year of functioning. The peri-implant sulcus can and does harbour potential periodontal pathogens without signs of peri-implantitis during the evaluation period of 1 year.", "Evidence-based reports are needed to support the application of a one-stage surgical protocol for unsplinted implants supporting mandibular overdentures.\n To examine the feasibility and success of using two different dental implant systems (originally designed for two-stage operative technique) using a one-stage operative procedure in patients being rehabilitated with implant mandibular overdentures.\n The study sample involved 24 edentulous subjects (aged 55-80 yr) randomly allocated to two different implant systems, one with a machined titanium implant surface (Steri-Oss, Nobel Biocare, Göteborg, Sweden) and the other with a roughened titanium surface (Southern Implants, Ltd., Irene, South Africa). Two unsplinted implants to support implant overdentures were placed in the anterior mandible of all patients, using a standardized one-stage surgical and prosthodontic procedure. Primary stability and bicortical anchorage of the implants was mandatory before healing abutments were connected at the time of implant placement. Implant overdentures and their respective matrices were inserted following a standard 12-week healing period. Data relating to mobility tests, radiographs, and peri-implant parameters were documented at 12, 16, and 52 weeks after surgery.\n A success rate of 95.8% for the Steri-Oss and 100% for the Southern Implants was found, without any statistically significant differences in the marginal bone loss. Significant changes in Periotest values were observed for both types between 12 and 52 weeks (p < .001). Minor changes were observed in the peri-implant parameters evaluated.\n These preliminary findings show a successful application of this one-stage approach for unsplinted implants supporting mandibular overdentures with Steri-Oss and Southern Implant Systems.", "Step-wise reduction in loading protocols is necessary to evaluate early loading of implants with mandibular overdentures.\n To compare the success rates of two different dental implant systems following conventional or early loading protocols in patients being rehabilitated with mandibular overdentures.\n Forty-eight edentulous participants were randomly allocated to two different implant systems: one with a machined titanium implant surface (Sterioss, Nobel Biocare, Yorba Linda, California, USA) and the other with a roughened titanium surface (Southern Implants, Irene, South Africa). For each system, the participants were further divided into control groups, in whom mandibular implant overdentures and their respective matrices were inserted following a standard 12-week healing period, and test groups, in whom a 6-week healing period was followed prior to identical loading. Two unsplinted implants to support implant overdentures were placed in the anterior mandible of all participants, using a standardized one-stage surgical procedure. Mobility tests and marginal bone levels, as well as peri-implant parameters, were evaluated at each baseline and 52 and 104 weeks after surgery.\n There was no statistically significant difference in the success rates of the two systems in either control or test groups. At the 2-year evaluation, a success rate was found of 87.5% and 70.8% for the control and test Sterioss groups, respectively, and 83.3% and 100% for the control and test Southern Implants groups were observed. For the Sterioss groups, eight implants were lost at an early stage: seven in the test group and one in the control group. For the Southern Implants control and test groups, no failures were seen at any time interval. There were no significant differences in marginal bone loss, Periotest values, and peri-implant parameters between implant systems or between any of the control or test groups.\n Early loading, with step-wise reductions in loading protocols, of unsplinted machined Sterioss and roughened Southern Implants fixtures with mandibular overdentures is possible for up to 2 years.", "The aim of the present study was to compare the treatment outcome of TiUnite- and turned-surfaced Brånemark System (Nobel Biocare AB, Göteborg, Sweden) implants when applying immediate loading of cross-arch designed fixed partial dentures in the anterior mandible.\n Fifteen patients with edentulous mandibles participated in the study. In one half of the jaw, between the exit of the nerve-vessel bundle and the midline, one type of implant was placed and in the remaining half the other type. The implants were loaded the day of surgery via a fixed, temporary supra-construction. Ten days later, the permanent one was screw retained to the implant pillars.\n The present 18-month clinical trial failed to demonstrate any differences regarding healing and cumulative success rate of an an-oxidized implant surface (TiUnite) and a turned (turned) one when implants in the anterior mandible were exposed to functional load within 24 hours after installation.\n A high predictability regarding the treatment outcome for immediately loaded Brånemark implants in the anterior mandible was observed. Furthermore, no difference between the traditional turned and the an-oxidized implant surface (TiUnite) could be observed. However, it has to be stressed that all implants (irrespective of surface) were placed in the anterior mandible and also that all the patients demonstrated a high level of oral hygiene.", "To compare implants with a rough surface in their whole length (FR) with implants having a 2 mm coronal machined portion (PR) when used in association with a sinus-lift procedure.\n Twenty-six patients with 2 mm< or =x< or =9 mm residual alveolar crest were prosthetically restored with implants after a staged sinus-lift procedure using osteotomes. In 13 randomly chosen patients, no more than one FR implant was placed (test group), while the rest were PR implants. The other 13 patients received only PR implants (control group). For comparisons, only one implant from each patient was used, i.e., from the test group only the 13 FR implants were used, while from the control group, one PR implant was randomly chosen. The presence/absence of plaque, BOP, PPD and REC were registered at the day of delivery of the restorations and after 1 year. Residual alveolar crest height and marginal bone levels around the implants were evaluated on standardized periapical radiographs taken at various stages.\n Four FR and two PR implants were lost, and the cumulative survival rate was 82.9% (six lost out of 35). There were no significant differences between the two groups. Implant type, residual alveolar crest height, time of osseointegration, time of implant loading and smoking did not seem to influence implant survival.\n FR and PR implants placed in augmented sinuses did not differ in their clinical performance.", "In a randomized prospective study, two implant systems were compared in forty consecutive patients treated for mandibular edentulism. The patients were randomly allotted for treatment by the Brånemark two-stage (submerged) system (BRS), or the ITI(R) one-stage (non-submerged) system. In all, 102 Brånemark selftapping implants and 106 ITI hollow screw implants were installed and all patients were treated with full bridges. Biological and prosthodontic parameters, complications, success rates, clinical efficacy, patient satisfaction and resource requirements were evaluated. No differences were found in plaque accumulation, bleeding or complications during the follow-up period. The BRS group showed deeper periimplant sulcus, less attached mucosa, larger bridge-mucosa distance and higher Periotest values. Prosthetic complications were not related to the configuration of the implant systems. After 3 years, the cumulative success rates were 97.9% and 96.8% for the Brånemark and ITI systems, respectively (difference not statistically significant). One implant in the BRS group had failed to osseointegrate at the time of abutment connection, and another was lost after 2 years due to progressive breakdown of bone. In the ITI group, three implants showed progressive bone loss after 1-3 years associated with periimplant infection. All 40 bridges were intact and remained stable throughout the study. There was general patient satisfaction, but about half the Brånemark patients reported difficulty in coping with the surgical procedures. Treatment time was similar for the two systems. It is concluded that both systems meet the current requirements for dental implant systems in the treatment of mandibular edentulism." ]

[ "15064028", "1346182" ]

[ "Clinical, psychosocial, and economic effects of antenatal day care for three medical complications of pregnancy: a randomised controlled trial of 395 women.", "Randomised controlled trial of day care for hypertension in pregnancy." ]

[ "Day care is increasingly being used for complications of pregnancy, but there is little published evidence on its efficacy. We assessed the clinical, psychosocial, and economic effects of day care for three pregnancy complications in a randomised trial of day care versus standard care on an antenatal ward.\n 395 women were randomly assigned day (263) or ward (132) care in a ratio of two to one, stratified for major diagnostic categories (non-proteinuric hypertension, proteinuric hypertension, and preterm premature rupture of membranes). The research hypothesis was that for these disorders, as an alternative to admission, antenatal day care will reduce specified interventions and investigations, result in no differences in clinical outcome, lead to greater satisfaction and psychological wellbeing, and be more cost-effective. Data were collected through case-note review, self-report questionnaires (response rates 81.0% or higher) and via the hospital's financial system. Analysis was by intention to treat.\n All participants were included in the analyses. There were no differences between the groups in antenatal tests or investigations or intrapartum interventions. The total duration of antenatal care episodes was shorter in the day-care group than in the ward group (median 17 [IQR 5-9] vs 57 [35-123] h; p=0.001). Overall stay was also significantly shorter in the day-care group (mean 7.22 [SE 0.31] vs 8.53 [0.44]; p=0.014). The median number of care episodes was three (range one to 14) in the day-care group and two (one to nine) in the ward group (p=0.01). There were no statistically or clinically significant differences in maternal or perinatal outcomes. The day-care group reported greater satisfaction, with no evidence of unintended psychosocial sequelae. There was no significant difference in either average cost per patient or average cost per day of care.\n Since clinical outcomes and costs are similar, adoption by maternity services of a policy providing specified women with the choice between admission and day-unit care seems appropriate.", "Our aim was to assess the effect of the introduction of a day-care unit on the care of women with non-proteinuric hypertension in pregnancy. A randomised controlled trial was carried out on 54 women who presented at 26 weeks of pregnancy or later with non-proteinuric hypertension (systolic blood pressure 150-170 mm Hg and/or diastolic pressure 90-105 mm Hg on two occasions at least 15 min apart). 30 women were allocated to care by the day unit and 24 were managed according to the established practice of their clinicians without access to the day unit (control group). Women in the control group spent on average 4.6 times longer as inpatients (difference in mean stay 4.0 days [95% confidence interval 2.1-5.9 days]) than the day-unit group and were 8.8 times (95% CI 3.0-25.8) more likely to be admitted to hospital. Induction of labour was 4.9 times (95% CI 1.6-13.8) more likely in the control than in the day-unit group and the development of proteinuria 11.4 times (95% CI 1.8-71.4) more likely. The control group had a mean of 1.5 fewer hospital outpatient visits (95% CI 0.36-2.64). The groups did not differ in their use of antihypertensive drugs. Day-unit care for hypertension in pregnancy significantly reduced the need for and the length of antenatal inpatient admissions and the number of medical interventions, at the cost of an increase in outpatient attendances. Our results are further evidence that inpatient care does not improve outcomes or prevent the development of proteinuria in this disorder." ]

[ "14632856", "10649153", "9555556", "8655825", "16142556", "17180553", "565593", "11789743", "12074820", "8801153", "15627777", "2729386", "6360297", "3377716", "10411835", "7802070", "12707868", "8694079", "8692511", "21823854", "2750828", "11172123", "9246967", "7921936", "10759276", "3727190", "15882720", "20096179", "16242695", "8903550", "9916960", "12114234" ]

[ "Stress incontinence surgery for patients presenting with mixed incontinence and a normal cystometrogram.", "A prospective randomized study comparing modified Burch retropubic urethropexy and suburethral sling for treatment of genuine stress incontinence with low-pressure urethra.", "Comparative analysis of bladder neck suspension using Raz, Burch and transvaginal Burch procedures. A 3-year randomized prospective study.", "The pre- and postsurgical nursing of women with stress incontinence.", "Tension free vaginal tape versus Burch colposuspension for treatment of female stress urinary incontinence.", "A randomized comparison of transobturator tape and Burch colposuspension in the treatment of female stress urinary incontinence.", "A urodynamic evaluation of the effects of abdominal urethrocystopexy and vaginal sling urethroplasty in women with stress incontinence.", "Comparison of pubovaginal sling and burch colposuspension procedures in type I/II genuine stress incontinence.", "Burch colposuspension and tension-free vaginal tape in the management of stress urinary incontinence in women.", "Genuine stress incontinence: prospective randomized comparison of two operative methods.", "Randomized comparison of Burch urethropexy procedures concomitant with gynecologic operations.", "Comparison of three different surgical procedures for genuine stress incontinence: prospective randomized study.", "A trial comparing the Stamey bladder neck suspension procedure with colposuspension for the treatment of stress incontinence.", "Stress urinary incontinence: a comparative study of surgical treatment by the Marshall-Marchetti-Krantz technique with endoscopic suspension of the bladder neck. Second report.", "Marshall-Marchetti-Krantz urethropexy and Burch colposuspension for stress urinary incontinence in women with low pressure and hypermobility of the urethra: early results of a prospective randomized clinical trial.", "Burch colposuspension versus modified Marshall-Marchetti-Krantz urethropexy for primary genuine stress urinary incontinence: a prospective, randomized clinical trial.", "Comparison of tension-free vaginal taping versus modified Burch colposuspension on urethral obstruction: a randomized controlled trial.", "A randomized comparison of Burch colposuspension and abdominal paravaginal defect repair for female stress urinary incontinence.", "Comparison of Burch and lyodura sling procedures for repair of unsuccessful incontinence surgery.", "Comparison of transobturator tape (TOT) vs Burch method in treatment of stress urinary incontinence.", "Primary stress urinary incontinence and pelvic relaxation: prospective randomized comparison of three different operations.", "Modified Burch colposuspension: laparoscopy versus laparotomy.", "Prospective comparison of laparoscopic and traditional colposuspensions in the treatment of genuine stress incontinence.", "A prospective randomized trial comparing a modified needle suspension procedure with the vagina/obturator shelf procedure for genuine stress incontinence.", "Randomised comparison of Burch colposuspension versus anterior colporrhaphy in women with stress urinary incontinence and anterior vaginal wall prolapse.", "Pelvic floor exercise versus surgery for female urinary stress incontinence.", "Multicenter randomized clinical trial comparing surgery and collagen injections for treatment of female stress urinary incontinence.", "A three year follow-up of a prospective open randomized trial to compare tension-free vaginal tape with Burch colposuspension for treatment of female stress urinary incontinence.", "Comparison of the efficacy of Burch colposuspension, pubovaginal sling, and tension-free vaginal tape for stress urinary incontinence.", "Burch colposuspension versus stamey endoscopic bladder neck suspension: a urodynamic appraisal.", "A randomized trial of burch retropubic urethropexy and anterior colporrhaphy for stress urinary incontinence.", "Prospective multicentre randomised trial of tension-free vaginal tape and colposuspension as primary treatment for stress incontinence." ]

[ "To evaluate the outcome of surgery for stress urinary incontinence (SUI) in patients presenting with a combination of stress and sensory urge UI.\n The study comprised 75 women presenting with mixed incontinence; the most important inclusion criterion was a negative cystometrogram for detrusor overactivity. Based on random selection, a third of the patients received a 6-month course of anticholinergic treatment (group 1) and 50 (group 2) had surgery for SUI. The surgical procedure depended on the Valsalva leak-point pressure (VLPP); those with a VLPP of > or = 90 cmH2O underwent Burch retropubic bladder neck suspension (group 2a, 24 patients) while 26 (group 2b) with a VLPP of < 90 cmH2O had pubovaginal sling (PVS) surgery. A further group of 20 patients with pure SUI (no urge UI) underwent surgery (PVS in 12 and Burch in eight) as a control group (group 3). After at least 6 months of follow-up (mean 9.3, sd 1.7), 68 patients were evaluable; they were assessed subjectively and objectively for dryness, and by a urodynamic evaluation and quantitative assessment using the SEAPI scoring system.\n In group 1 none of the patients became completely dry; there was persistent stress with and without urge UI in nine (43%) and 12 (57%) of the available 21 patients, respectively. Only three of those who had persistent SUI with no urge in the whole study group were satisfied and chose to continue anticholinergic therapy despite SUI. In this group the mean (sd) improvement in the subjective and objective SEAPI score was 3.4 (1.0) and 2.3 (3.8), respectively. In group 2a, 20 of the available 23 patients (87%) became completely dry (both stress and urge continent). The mean improvement in the SEAPI scores was 7.8 (0.9) and 7.8 (1.3), respectively. In group 2b, 20 of the 24 patients (83%) became completely dry, with mean improvements in SEAPI scores of 8.2 (0.4) and 7.9 (0.3), respectively. The improvement was statistically significant after surgery, vs anticholinergic therapy, for all variables (P < 0.05). The incidence of persistent urge UI was highest in group 1 (43%), being 13% in group 2 (13% and 12% in 2a and b, respectively). In group 3 there was de novo urge UI in four of the 20 patients, and not significantly different from that in group 2.\n Most patients with mixed stress and urge UI and a normal cystometrogram were cured of both symptoms by surgery. The incidence of residual urge in such patients was no higher than that of de novo urge after surgery in patients with genuine SUI.", "The aim of this study was to compare a modified Burch procedure with a suburethral sling for the treatment of stress incontinence complicated by a low-pressure urethra.\n Thirty-six women with stress incontinence, low-pressure urethra, and urethral hypermobility (straining cotton swab angle >/=30 degrees ) were randomly assigned to undergo either a modified Burch procedure (n = 19) or a suburethral sling (n = 17). Objective and subjective cure rates at 3 months after the operation were the primary outcome measures. Comparisons of group means were performed with the Student t test for independent groups, and proportions were compared with the Fisher exact test.\n After the operation the 2 groups had statistically similar cure rates and voiding function. Urethral closure pressure, pressure transmission ratios, and maximum detrusor pressure during voiding were significantly higher in the sling group.\n At 3 months there were no clinically significant differences between the groups treated with suburethral sling and modified Burch procedures.", "Ever since Pereyra described needle suspension of the bladder neck for the treatment of stress urinary incontinence in women, numerous modifications have been presented. There were variations in the success reported by different authors. We report 3-year follow-up results in 146 women operated on for stress urinary incontinence using Raz, Burch and our own new procedures.\n During a 5-year period, 146 women were operated on for genuine stress urinary incontinence. Using the method of Raz, and transvaginal Burch as well as the Burch retropubic urethropexy, a modified bladder neck suspension was performed in 46 (32%), 44 (30%) and 56 (38%) patients, respectively. In all patients a prior gynecological or urological operation for urinary incontinence and a clear neuropathic condition had been excluded before surgery. The routine diagnostic procedure consisted of multichannel cystometry, voiding cystourethrography, infusion urography and cystoscopy. A pressure-flow electromyography study was done in patients with a residual volume greater than 50 ml following voiding. The operations were performed by the same surgeon (I.G.). Initial follow-up was done after 12 months and then every year.\n Urodynamic testing did not reveal significant differences between Burch and Raz (p = 0.2652), Raz and transvaginal Burch (p = 0.5745) as well as between Burch and transvaginal Burch procedures (p = 0.7602; Fisher's exact test). Three years after surgery, 50 of 56 (89.3%; Burch procedure), 37 of 46 (80.4%; Raz modification) and 38 of 44 patients (86.4%; transvaginal Burch) were continent.\n There is no reason (except patient condition) to prefer any of the numerous modifications of bladder neck suspension. We believe that the success of the operation lies in adequate mobilization of the bladder neck and urethra as well as in a surgeon's familiarity with the procedure.", "The aim of the present study was to evaluate subjective and objective methods used for the investigation of stress urinary incontinence (SUI) and to compare the outcome of two different surgical techniques regarding cure rate, postoperative nursing, bladder drainage and postoperative pain relief. The study included 45 women with SUI, randomized either to retropubic urethrocystopexy (n = 30) or pubococcygeal repair (n = 15). The assessment included medical history, gynaecological examination, urine analysis and culture, residual urine, pad test, frequency-continence charts, water urethrocystoscopy, continence test, and cystometry with micturition analysis. Moreover, Beck's Depression Inventory and the Eysenck Personality Inventory were used before surgery. One year after surgery no significant difference in subjective cure rate was found between the two surgical methods (73% vs. 80%, respectively). According to pad tests, 67% of the women in the urethrocystopexy group and 47% in the pubococcygeal repair group had ceased to leak urine. The bladder volume increased significantly in both groups. Sixty-three per cent of the women in the urethrocystopexy and 33% in the pubococcygeal repair group experienced severe to very severe postoperative pain. In these groups, significantly more dysphoric women were found as compared with the group of women with less postoperative pain. Furthermore, the women with more severe pain scored higher on the neuroticism scale. These findings indicate the importance of personality factors in the treatment and nursing women with SUI.", "Many surgical procedures have been proposed for treatment of stress urinary incontinence (SUI) but none of them has proved completely successful. The aim of this study is to compare the efficacy and safety of tension free vaginal tape (TVT) with Burch colposuspension in the treatment of SIU.\n Fifty female patients, presenting with SUI were randomly divided into two equal groups. SUI was confirmed using urodynamic study in all patients. Group 1 (n=25) patients underwent Burch colposuspension while Group 2 (n=25) underwent TVT. Patients with high grade cystocele, previous surgical failure for SUI, uninhibited detrusor contraction during bladder filling on urodynamic study and incompetent internal sphincters were excluded from this study. A patient was declared cured of SUI, if 3-6 months after surgery she had no SUI. The procedure was judged to be a failure if 3-6 months after surgery, patient had SUI.\n In group 1 patients, 72% were completely cured, 16% improved and 12% showed no improvement. In group 2 patients, 72 were completely cured, 20% improved and only 8% showed no improvement. There was no difference between the two groups in terms of cure rates. Operative time for TVT was significantly less compared to Burch. Postoperative pain was less in TVT than Burch. Return to normal activity was earlier in TVT compared to Burch group. Intra operative perforation of the urinary bladder occurred in 8% of patients in group 2. Urine retention occurred in 12% of patients in group 1 compared to 20% in group 2. This was successfully managed conservatively. De novo urgency developed in 12% in group I and 8% in group II and was successfully managed by medical treatment.\n The success rates of TVT and Burch colposuspension in the treatment of SUI in our experience are very similar. However, TVT is associated with less morbidity. We recommend TVT procedure for females with genuine SUI.", "This study was performed to compare the efficacy of transobturator tape (TOT) and Burch colposuspension in the treatment of female stress urinary incontinence (SUI). This is a prospective randomized single blind study of 100 women diagnosed as with urodynamic SUI who were randomized either to TOT procedure (n = 49) or Burch procedure (n = 51). The outcome was evaluated at 1 and 2 years. The mean operation time and hospital stay were significantly shorter in the TOT group compared to Burch group (p < 0.001). Procedure-related complications and postoperative voiding problems including postoperative urinary retention, de novo voiding difficulties and de novo urge incontinence were similar in the two groups. Both the subjective and objective cure rates of SUI at 1 year were 85.7 and 87.5%, respectively, in the TOT group. This was similar to subjective and objective cure rates at one year of 84.3% (p = 0.8) and 80.3% (p = 0.4) in the Burch group, respectively. At the end of 2 years, 32 patients were available in the TOT group and 31 patients were available in the Burch group for analysis. Both the subjective and objective cure rates of SUI at 2 years were 87.5 and 87.5% in the TOT group which was similar to the 87% (p = 0.9) and 83.8% (p = 0.6) in the Burch group, respectively. TOT procedure results in similar cure rates of SUI at 1 and 2 years compared to Burch procedure. The TOT procedure has a shorter operative time and length of hospital stay.", "nan", "We compared morbidity and success rate of pubovaginal sling with Burch colposuspension operations in Type I/type II genuine stress urinary incontinence (GSI). The study included patients who had no preoperative detrusor instability (DI), no recurrent GSI, no severe pelvic prolapsus and whose Valsalva leak point pressure (VLPP) values were higher than 90 cm water. Twenty three of free-rectus fascial sling and 23 of Burch colposuspension operations were performed randomly on the patients by a single surgeon. There was no statistical difference between patients in terms of age, BMI, parity, number of daily pads used and preoperative bladder neck mobility. Operation time, change in hematocrit, spontaneous voiding time, length of hospitalization and urinary infection were not different in 2 procedures. 17 patients from both groups could be compared after one year. The bladder neck mobility of both groups were similar. One surgical failure, 1 DI, 1 severe cystocele and 1 enterocele were found in the Burch group while only 1 DI was found in the pubovaginal sling group. When pubovaginal sling operation was performed as the primary surgery on the patients with type I/II GSI, the morbidity, complications and 1 year success rate are the same as Burch procedure.", "Objective of the study was to compare the efficacy and the complications of tension-free vaginal tape (TVT) and Burch colposuspension in the treatment of female genuine stress incontinence (GSI).\n In this controlled, prospective, randomized study, participated 35 patients who underwent Burch colposuspension and 36 patients that underwent TVT procedure. Patients with prolapse more than first degree, previous surgical treatment of stress urinary incontinence (SUI) and detrusor instability were excluded from the study.\n The operative time for TVT was significantly shorter compared to BC. The severity and duration of postoperative pain for TVT was significantly less compared to BC. The necessary time for return to normal activity was 10 days for TVT and 21 days for BC. The cure rate after 24 months of follow-up was as follows: TVT: 84% and BC: 86%, while the improvement was 7% for TVT and 6% for BC.\n TVT and Burch colposuspension are equally effective in the management of female GSI at two years follow-up. TVT procedure requires much less operative time, has much shorter hospitalization time, with significantly less postoperative pain and faster return to normal daily activities than Burch colposuspension.", "Eighty-one women with clinical and urodynamic findings of genuine stress incontinence and genital prolapse were randomly selected to be surgically treated with either anterior colporrhaphy or Burch colposuspension. Each patient had a complete clinical and urodynamic evaluation before surgery and at 2 months and 3 years after surgery. Differences in cure rates between the two procedures at the 2-month post-operative evaluation were insignificant; however, at the 3-year post-surgical evaluation, the cure rate of women who had undergone Burch colposuspension was significantly higher than that of women who had undergone anterior colporrhaphy (cure rates were 88% and 57%, respectively; P < 0.001). The Burch colposuspension was more effective than the anterior colporrhaphy in the stabilization of the bladder base, neck and proximal urethra as confirmed by transvaginal sonography. Post-operative spontaneous voiding was uneventful in both procedures. Results of this study demonstrate that the Burch colposuspension in our hands was more effective in treating genuine stress incontinence and pelvic relaxation than was anterior colporrhaphy.", "We compared the success of laparoscopic Burch colposuspension with the laparotomic Burch colposuspension for the treatment of genuine stress incontinence (GSI) concomitant with gynecologic operations.\n Fifty-two women with symptoms of GSI, also requiring additional gynecologic operations, were randomly assigned to undergo laparoscopic (n = 26) or laparotomic (n = 26) Burch colposuspension. For all patients complete histories were taken and physical examination, urinalysis, urine culture, multi-channel urodynamics with cystometry, uroflowmetry, and measurement of Valsalva leak-point pressure were performed. Variables analyzed included: age, surgical time, length of catheterization, number of days in hospital, and complications.\n Both groups were similar in age, parity and menopausal status. Valsalva leak-point pressure significantly increased in the laparoscopy group after the operation. There were no statistical differences in other urodynamics in both groups. The mean operating time in the laparoscopy group was longer than in the laparotomy group. The laparoscopy group required a significantly shorter hospitalization and catheterization than the laparotomy group. The success and complication rates did not differ significantly for both groups.\n The laparoscopic approach for the treatment of GSI in patients requiring additional gynecologic procedures is associated with a shorter duration of hospital stay compared with the abdominal approach.\n Copyright 2005 S. Karger AG, Basel.", "One hundred seven consecutive patients with clinical and urodynamic findings of genuine stress incontinence not previously treated were prospectively allocated in a randomized manner to one of three surgical procedures: anterior colporrhaphy, revised Pereyra procedure, or Burch retropubic urethropexy. Randomization included the surgical procedure and choice of surgeon (one of the three authors). Clinical and urodynamic evaluations were repeated at 3 months and 1 year after surgery. Differences in cure rates among the three procedures at the 3-month postoperative evaluation were insignificant (82%, 84%, and 92% for the anterior colporrhaphy, Pereyra, and Burch respectively) but became statistically significant at the 1 year postoperative evaluation (cure rates of 65%, 72%, and 91% for the anterior colporrhaphy, Pereyra, and Burch respectively, p less than 0.05). In our hands the Burch procedure stabilized the urethrovesical junction and prevented its descent during straining (evaluated by a postoperative Q-tip test) more effectively than either the Pereyra or anterior colporrhaphy. No procedure resulted in severe postoperative voiding difficulties. The present prospective randomized study demonstrates that in our hands the abdominal retropubic operation for genuine stress incontinence in patients not previously operated on results in a higher cure rate when compared with anterior colporrhaphy or Pereyra procedure.", "Fifty-one women with urodynamically proven genuine stress incontinence were alternately allocated to either colposuspension or a Stamey-type bladder neck suspension. One year after operation 89% of the patients who had had a colposuspension were subjectively cured and 73% were objectively normal. In the Stamey procedure group these figures were 76 and 40% respectively. The Stamey procedure is a quicker, simpler and a lesser procedure but has a higher incidence of post-operative voiding difficulties and residual urge symptoms. Colposuspension is to be preferred for the younger, healthier patient. The Stamey procedure is useful in the elderly, obese or unfit patient or the patient who has had multiple previous surgical attempts at a cure.", "nan", "The aim of the study was to compare the effects of Burch colposuspension and Marshall-Marchetti-Krantz urethropexy with videourethroscopic control in the correction of stress urinary incontinence in patients with low pressure and hypermobility of the urethra.\n Thirty women were randomly assigned to undergo 1 of the 2 surgical procedures from November 1993 to May 1996 (15 Burch colposuspensions and 15 Marshall-Marchetti-Krantz urethropexies) and were evaluated subjectively and objectively for stress urinary incontinence at 2 and 12 months. Data obtained were analyzed with the Student t test, the Fisher exact test, and the Wilcoxon signed rank test.\n At 1 year of follow-up 15 women in the Marshall-Marchetti-Krantz urethropexy group (100%) and 10 women in the Burch colposuspension group (66%) were subjectively considered cured (P =.02, 2-tailed Fisher exact test), and stress test results were negative in 14 women (93%) and 8 women (53%), respectively (P =.017, 2-tailed Fisher exact test). The resumption of spontaneous voiding was attained after 6.5 +/- 3.3 days in the Burch colposuspension group and in 20.5 +/- 13.4 days in the Marshall-Marchetti-Krantz urethropexy group (P <.001, 2-tailed Wilcoxon rank sum test).\n The high cure rate and low associated morbidity mark the Marshall-Marchetti-Krantz procedure with videourethroscopic control as more effective than Burch colposuspension in repairing stress urinary incontinence associated with low pressure and hypermobility of the urethra.", "Our purpose was to compare the effects of the Burch colposuspension with those of the modified Marshall-Marchetti-Krantz urethropexy.\n Eighty women underwent the two types of operation. A full urodynamic investigation was repeated 6 months after surgery.\n Clinical follow-up continued for 2 to 7 years. Differences in subjective and objective cure rates were not statistically significant (respectively, 92% and 80% for the Burch colposuspension and 85 and 65% for the modified Marshall-Marchetti-Krantz urethropexy). The latter induced a longer hospital stay (7.4 vs 6.3 days, p = 0.001), a later resumption of spontaneous voiding (13.8 vs 8.5 days, p = 0.002), and was associated with considerable complications (one case of blood replacement for retropubic hematoma, one case of severe voiding difficulty, one case of further treatment for stress incontinence, and three cases of symptomatic de novo detrusor instability).\n For its high cure rate, short time to resumption of spontaneous voiding, short hospital stay, and low associated morbidity, the Burch colposuspension should remain the procedure of choice for stress incontinence.", "To determine whether the tension-free vaginal tape (TVT) procedure affects the mechanics of voiding in women with genuine stress incontinence (GSI).\n Between July of 1997 and July of 1999, 116 women with GSI in the absence of pelvic prolapse underwent a randomized controlled study of TVT vs. modified Burch colposuspension. The trial was conducted by using a standardized protocol, including strict criteria for excluding preexisting bladder outlet obstruction (BOO). Urodynamic studies including free flowmetry, filling (provocative) and voiding cystometry, and 1-hour pad test were performed before and at least 1 year after the operation. The Blaivas and Groutz nomogram was used as another criteria to assess the pre- and postoperative BOO.\n Eighteen women were excluded from the study as a result of having preexisting BOO and an additional 8 were lost to follow-up. The comparison between pre- and postoperative variables for each procedure revealed that maximal flow rate of noninvasive uroflowmetry was significantly lower after operation in both groups (P = 0.009, P = 0.010, respectively). Detrusor pressure at maximal flow and urethral resistance were significantly higher and micturition volumes significantly lower after operation in the Burch group (P < 0.001, P < 0.001, P = 0.029, respectively). The difference between pre- and postoperative distribution of the obstruction nomogram of the Burch group was significantly different (P = 0.023).\n Based on strict exclusion criteria for preoperative BOO, our findings strongly suggest that with a median 22 months (range, 12 to 36 months) of follow-up, a properly performed tension-free vaginal tape procedure does not cause urethral obstruction.\n Copyright 2003 Wiley-Liss, Inc.", "Our aim was to compare Burch colposuspension and paravaginal repair for success rates, complications, and urodynamic effects when the procedures are used in the treatment of stress urinary incontinence.\n Thirty-six patients were enrolled. A full urodynamic evaluation was repeated 6 months postoperatively.\n Twelve (67%) and 17 (94%) subjects (Burch colposuspension vs paravaginal repair) voided spontaneously before discharge (p = 0.04). One patient receiving the Burch procedure underwent urethral dilation for urinary retention. Follow-up was for 1 to 3 years. Differences in subjective and objective cure rates favored the Burch colposuspension over the paravaginal repair: 100% versus 72% (p = 0.02) and 100% versus 61% (p = 0.004), respectively. The paravaginal repair did not produce significant modifications in profilometry. Postoperatively, cotton swab tests had negative results in all patients with the Burch operation and in 33% of those with the paravaginal repair (p = 0.01).\n Paravaginal repair is not recommended for the treatment of stress incontinence, although it was accompanied by a more immediate resumption of voiding.", "To assess the effectiveness and late postoperative morbidity of the Burch procedure and the sling procedure for the treatment of recurrent urinary stress incontinence after vaginal hysterectomy and anterior repair.\n Clinical, urodynamic, and sonographic examinations were done on 77 women suffering with recurrent urinary stress incontinence. The women were randomized to two groups, modified Burch colposuspension and lyophilized dura mater sling surgery; 72 women were reexamined 32-48 months after these procedures.\n The cure rate at 32-48 months' follow-up was 86% for the Burch procedure and 92% for the sling. Women who had had the sling procedure demonstrated a clear decrease in maximal bladder capacity, from 330 to 240 mL (P < .05). In both groups, stress profiles demonstrated a shift of maximal pressure point toward the proximal urethra and a significant improvement in pressure transmission (P < .05). The post-operative patients who had persistent incontinence were found to have insufficient elevation of the bladder neck (less than 10 mm). The uroflow examination showed an increase of urination time in both groups. The incidence of bladder problems was 10% with the Burch procedure and 29% with the sling procedure; however, 13% of the Burch group developed rectoceles.\n Both procedures offer a high rate of success. We believe that the sling surgery should be used only in certain special cases because of its higher rate of complications, but that posterior vaginal repair should be considered after modified Burch colposuspension because of the possibility of rectocele and enterocele.", "This study aim was to compare the efficacy of transobturator tape (TOT) as a new sling procedure, and Burch colposuspension as the gold standard surgical technique, in the treatment of stress urinary incontinence (SUI). This prospective randomised clinical trial was conducted on 62 women with SUI diagnosed with urodynamic test in Vali-e-Asr Hospital, Tehran, Iran. Patients were allocated into two surgery groups, randomly; TOT and Burch (31 patients in each group). After treatment, they were followed-up for long-term outcome. The average duration of follow-up was 22 and 28 months in the TOT and Burch group, respectively. Operation duration and hospital stay in the TOT group was significantly less than the Burch group (p=0.001). The rate of complete cure, improvement and failure in the TOT group was 90.3%, 9.7% and 0%, respectively, as well as 74.2%, 19.4% and 6.5% in the Burch group. In the TOT group, 90.3% of patients were very satisfied, 6.5% moderately satisfied and 3.2% were less satisfied; none of them were unsatisfied. It is concluded that the TOT procedure is a safe and effective option with less operation time and shorter in-hospital stay for SUI treatment.", "There were 289 women with clinical and urodynamic diagnosis of primary stress urinary incontinence, stable bladder, and pelvic relaxation who underwent a single-stage surgical procedure because of incontinence and pelvic relaxation. Patients underwent one of three surgical procedures because of stress incontinence--anterior colporrhaphy, revised Pereyra procedure, or Burch retropubic urethropexy. Decisions with regard to the type of bladder neck suspension and the surgeon were made randomly with a randomization table. Each patient had a complete clinical and urodynamic evaluation before surgery and at 3 and 12 months after surgery. Cure rate as defined by strict clinical and urodynamic criteria was not significantly different among the three groups at the 3-month postsurgical evaluations; however, at the 12-month postsurgical evaluations, the cure rate among women who underwent Burch urethropexy (n = 101) was significantly higher than that of either Pereyra or anterior colporrhaphy (cure rates were 87%, 70%, and 69%, respectively; p less than 0.01). The Burch urethropexy was more effective than the Pereyra procedure or anterior colporrhaphy in the stabilization of the bladder base and resulted in a significantly better cure rate in women with primary stress urinary incontinence and pelvic relaxation.", "To compare results of laparoscopic Burch colposuspension with those of classic Burch colposuspension, and to assess complications, results, and morbidity associated with each procedure.\n Prospective, randomized study (Canadian Task Force classification I).\n Minimal access surgery unit.\n Seventy-four women with genuine stress incontinence.\n Laparoscopic and classic Burch colposuspensions. MEASUREMENTS AND MEAN RESULTS: Mean operating times for laparoscopic and open surgery were 70.18 +/- 16.54 and 53+/- 10.05 minutes, respectively (p <0.001). Mean blood loss was 42.75 +/- 7.2 and 240.5 +/- 35.5 ml, respectively (p <0.001). Postoperative analgesia requirement was significantly less with laparoscopy (p <0.001). Mean postoperative hospital stay was 36 +/- 6.3 hours for the laparoscopic group and 76+/- 10.4 hours for the open group p<0.001). Average time to return to light work was 8.5 and 31.5 days, respectively. Success rates were 90.9% at 6 months and 87.9% at 18 months in the laparoscopic group, compared with 90% and 85%, respectively, in the open group.\n Given equal efficacy of the two procedures, we prefer the laparoscopic approach since it is associated with lower morbidity, shorter hospital stay, and fewer complications. (J Am Assoc Gynecol Laparosc 8(1):99-106, 2001)", "To compare prospectively the results of laparoscopic and traditional colposuspensions in the treatment of genuine stress incontinence and to evaluate the efficacy, technique, and functional and anatomical changes after these two procedures.\n Ninety-two patients with urodynamically proven genuine stress incontinence participated in this study, with 46 patients randomly allocated to laparoscopic colposuspension, and the other 46 patients to the traditional procedures. All patients had repeat studies at least 3 months after operation.\n The bladder neck position was significantly elevated after operation either at rest or during straining in both groups (all p < 0.001), but it was higher in the traditional group than the laparoscopy group during straining (p < 0.05). Comparison of urodynamics before and after operation in both groups showed significantly increased minimal urethral resistance and improved pressure transmission ratios at the proximal urethra (Q2). The blood loss was less in the laparoscopy group. The duration of bladder drainage after laparoscopic colposuspension was shorter, and was not affected by subsequent laparotomy. The operative time was almost the same. The success rate of the laparoscopy group was lower than that of the traditional group (80.4% vs. 95.6%, p = 0.044). The complication rates were 10.8% and 17.4% respectively.\n Laparoscopic colposuspension is an effective method for the treatment of GSI, as documented by anatomical and functional assessments. However, the success rate is still lower than for the traditional procedure.", "To compare two procedures for the treatment of genuine stress incontinence in patients selected randomly.\n Fifty patients with proven genuine stress incontinence were randomized prospectively over a 3 year period to be treated either by a modified needle suspension (MNS) (n = 26) or by a vagina/obturator shelf (VOS) (n = 24) procedure.\n In patients who had not undergone previous surgery for incontinence, the VOS procedure was superior with 12 of 14 patients achieving continence compared with eight of 15 patients in the MNS group (P < 0.05). In women who had undergone previous surgery seven of 11 were continent following MNS compared with five of 10 after a VOS procedure. Both techniques had a much lower continence rate when compared with a classical colposuspension operation which was reported in a previous series.\n As a primary procedure VOS was more successful than MNS. In patients who had undergone previous surgery for incontinence neither procedure gave acceptable results.", "To compare the Burch colposuspension and the anterior colporrhaphy in women with both stress urinary incontinence and advanced anterior vaginal wall prolapse (cystocele).\n Prospective randomised study.\n Secondary referral centre, Urogynaecology Unit, San Gerardo Hospital, Monza, Italy.\n Seventy-one women undergoing surgery for primary genuine stress incontinence and concurrent grade 2 or 3 cystocele (descending at or outside the vaginal introitus).\n Full urodynamic investigation performed pre-operatively and repeated six months after surgery. Clinical follow up continued for 8 to 17 years.\n Subjective (patient history) and objective (negative stress test result) cure of stress incontinence. Assessment of cystocele recurrence.\n Thirty (86%) of the 35 evaluable women who had the Burch colposuspension and 17 (52%) of the 33 evaluable women who had the anterior colporrhaphy were subjectively cured (OR 5.6, 95% CI 1.6 to 21.6; P = 0.005). Objective cure rates were 74% (26 of 35) and 42% (14 of 33), respectively (OR 3.9, 95% CI 1.3 to 12.5; P = 0.02). A recurrent cystocele of grade 2 or 3 with or without prolapse at other vaginal sites was recorded in 34% (12 of 35) and 3% (1 of 33) of women, respectively (OR 16.7, 95% CI 2.0 to 368.1; P = 0.003).\n The Burch colposuspension was better in controlling stress incontinence but it lead to an unacceptable high rate of prolapse recurrence. The anterior colporrhaphy was more effective in restoring vaginal anatomy but it was accompanied by an unacceptable low cure rate of stress incontinence. Neither of the two operations is recommended for women who are suffering from a combination of stress incontinence and advanced cystocele.", "Fifty consecutive female patients with genuine urinary stress incontinence were randomized either to surgery or to a pelvic floor training program. The operative procedure was chosen according to the type of bladder suspension defect on micturition cystourethrography. The training program was given 5 times in weekly lessons and the patients were guided by trained physiotherapists. Surgery was superior to the pelvic floor training program both subjectively and objectively. However, a significant improvement was found following the training program. Forty-two percent were satisfied with the outcome of the training and did not want operation. We find physiotherapist-guided pelvic floor exercise a realistic alternative to surgery in patients with mild degrees of stress incontinence. Also patients with residual symptoms after surgery are candidates for pelvic floor training.", "To compare, in a multicenter, randomized clinical trial, collagen injections versus surgery with regard to efficacy, quality of life, satisfaction, and complications.\n Of 133 women with stress urinary incontinence, 66 were randomized to collagen injection and 67 to surgery (6 needle bladder neck suspensions, 19 Burch, and 29 slings). After randomization, 15 women refused their allocated treatment. \"Intent-to-treat\" and \"per protocol\" analyses were applied. Women assigned to collagen injection could receive up to three injections before it was considered a failure. A \"top-up\" injection was allowed within 3 months after cure. Success as the primary outcome at 12 months was defined as a dry 24-hour pad test (2.5 g or less of urine) after having received only the allocated intervention.\n The per protocol analysis showed that the success rate 12 months after collagen injections (53.1%) was much lower than that after surgery (72.2%). The difference was 19.1% (95% confidence interval -36.2% to -2%). The general and disease-specific quality-of-life scores measured by the Rand Medical Outcomes Study 36-item Health Survey and Incontinence Impact Questionnaire were similar in the two groups (P = 0.306). Women treated by surgery were, on average, more satisfied (79.6%) than those treated by collagen injection (67.2%), but the difference was not significant (P = 0.228). Finally, complications were less frequent and severe with collagen injection: 36 events in 23 subjects for collagen injection versus 84 events in 34 subjects for surgery (P = 0.03).\n One year after intervention, the success rate of collagen injection as a treatment for stress urinary incontinence was about 19% lower than that after surgery. This has to be tempered by the similar changes in quality of life and satisfaction in both groups and that the number and severity of complications were much greater after surgery than after collagen injection. The results of this study indicate that collagen injections might be a worthwhile alternative to surgery for the treatment of stress urinary incontinence.", "Evidence comparing the effectiveness of tension-free vaginal tape (TVT) with Burch colposuspension (CS) over a long-term follow-up is scarce.\n To compare TVT with CS as primary treatment for female stress urinary incontinence (SUI).\n Open randomised clinical trial with a three-year follow-up period.\n 49 consecutive women aged 35 to 70 with SUI demonstrated by a urodynamic study.\n Urology department of Severo Ochoa general hospital in Leganes, Madrid, Spain.\n 24 random patients treated with TVT and 25 with CS.\n Main variable: assessment before treatment and at six months, one year and three years after the operation using the incontinence severity index (ISI) and the incontinence impact questionnaire (IIQ). Secondary variable: three groups for assessing cure, improvement and failure rates.\n Time in surgery, consumption of postoperative analgesics and length of the postoperative hospital stay were lower in the TVT group (41.1 +/- 10.9 minutes; 6 [2.8-10.5] capsules and 1 [1-2] days vs. 57.1 +/- 18.3 minutes, 23.5 [18.0-31.5] capsules and 3 [3-3] days [p < 0.0001]). There was a significant reduction in ISI and IIQ scores in both groups and no differences in surgical complications, urgency, obstruction, one-hour pad test, urine culture, flowmetry, costs and cure rates at any moment during follow-up (cured/improved 76.2%, 78.3% and 77.3% at six months, one year and three years for TVT vs. 87.5%, 87.5% and 91.3% for CS; p = 0.32, p = 0.4 and p = 0.19).\n The trial is open, which can create observer bias. A study with a higher number of patients or a longer follow-up time could show differences between the procedures that we were unable to observe in this study, due to our budget and time limits.\n Based on both short-term and long-term results, TVT is as effective as CS for the treatment of SUI, and has similar subjective cure and surgical complication rates. Time in surgery, consumption of analgesics and length of postoperative hospital stay are all lower in the TVT group. In our clinical setting, with a one-day postoperative stay for TVT, the two procedures have similar costs.", "To compare the cure rate and confirm the clinical efficacy of the 3 most frequently performed surgical procedures for stress urinary incontinence (SUI).\n Between January 2001 and May 2003, 92 women with SUI were randomly assigned to undergo the Burch colposuspension (n=33), pubovaginal sling (n=28), or tension-free vaginal tape (n=31) at the Department of Obstetrics and Gynecology, Yonsei Medical Center, Seoul, Korea. Patient characteristics, urodynamic study results, cure rates at 3, 6, and 12 months, and complication rates were compared using the chi2 test.\n There were no statistically significant differences in the cure rates initially, but after 12 months the cure rate of the pubovaginal sling procedure was found to be significantly higher than those of the tension-free vaginal tape or Burch colposuspension procedures.\n The cure rate of the pubovaginal sling procedure was significantly higher after 1 year, but no difference in efficacy was observed between the 2 other procedures. A randomized prospective study of a larger population should be conducted.", "A total of 51 consecutive female patients with genuine stress incontinence who underwent a Burch or Stamey operation were clinically and urodynamically evaluated preoperatively at least 8 months postoperatively. Our study group consisted of 27 women who underwent the Burch colposuspension and 24 who had the Stamey endoscopic bladder neck suspension. The urodynamic parameters which were studied pre- and postoperatively were the maximum flow rate (Qmax), the residual urine (Vres), the first sensation (FS), the bladder capacity (BC), the maximum vesical pressure (Pves max), the detrusor pressure at maximum flow (Pdet/Qmax), the functional urethral length (Lfun) and the maximum closure pressure (Pclos max). The successful results of the operations were 89% for Burch and 83% for the Stamey procedure. As for differing objective urodynamic findings, the Qmax, Pclos max, Vres and Lfun for both groups were the only parameters which showed statistically significant difference after surgery. The statistical comparison of the postoperative urodynamic parameters of the two operative techniques showed that Lfun, Pves max and Pclos max had difference in favor of Burch colposuspension. There were not statistical differences in the other studied parameters. In conclusion, according to the differentiation in the values of Pclos max, Lfun and Pves max, the Burch technique seems to result in a higher increase of patient's urethral resistance.", "In a randomized trial, we compared the success of Burch retropubic urethropexy to the modified anterior colporrhaphy for the treatment of genuine stress urinary incontinence.\n Thirty-five patients with stress incontinence were randomly assigned to undergo Burch retropubic urethropexy or modified anterior colporrhaphy. Subjects had preoperative and 1-year postoperative physical examinations, multichannel urodynamic testing, 20-minute pad test, and subjective grading of incontinence severity with questionnaires. Data were evaluated using Fisher exact test, Wilcoxon two-sample test, logistic regression analysis, and analysis of variance.\n Objective cure 1 year postoperatively was significantly greater for the women treated by Burch retropubic urethropexy than by modified anterior colporrhaphy (16 of 18 [89%] versus five of 16 [31%], relative risk .15, 95% confidence interval .04, .59). Patients' subjective ratings of incontinence severity 1 year after surgical treatment were significantly lower in women who had Burch retropubic urethropexy.\n Burch retropubic urethropexy yields a significantly superior objective cure for genuine stress urinary incontinence than the modified anterior colporrhaphy in a randomized trial.", "To compare tension-free vaginal tape with colposuspension as primary treatment for stress incontinence.\n Multicentred randomised comparative trial.\n Gynaecology or urology departments in 14 centres in the United Kingdom and Eire, including university teaching hospitals and district general hospitals.\n 344 women with urodynamic stress incontinence; 175 randomised to tension-free vaginal tape and 169 to colposuspension\n Assessment before treatment and at six months postoperatively with the SF-36, the Bristol female lower urinary tract symptoms questionnaire, the EQ-5D health questionnaire, a one week urinary diary, one hour perineal pad test, cystometry, and, in some centres, urethral profilometry.\n 23 women in the colposuspension group and 5 in the vaginal tape group withdrew before surgery. No significant difference was found between the groups for cure rates: 115 (66%) women in the vaginal tape group and 97 (57%) in the colposuspension group were objectively cured (95% confidence interval for difference in cure -4.7% to 21.3%). Bladder injury was more common during the vaginal tape procedure; postoperative complications, in particular delayed resumption of micturition, were more common after colposuspension. Operation time, duration of hospital stay, and return to normal activity were all longer after colposuspension than after the vaginal tape procedure.\n Surgery with tension-free vaginal tape is associated with more operative complications than colposuspension, but colposuspension is associated with more postoperative complications and longer recovery. Vaginal tape shows promise for the treatment of urodynamic stress incontinence because of minimal access and rapid recovery times; cure rates at six months were comparable with colposuspension." ]

[ "12406815" ]

[ "Reductions in injury crashes associated with red light camera enforcement in oxnard, california." ]

[ "This study estimated the impact of red light camera enforcement on motor vehicle crashes in one of the first US communities to employ such cameras-Oxnard, California.\n Crash data were analyzed for Oxnard and for 3 comparison cities. Changes in crash frequencies were compared for Oxnard and control cities and for signalized and nonsignalized intersections by means of a generalized linear regression model.\n Overall, crashes at signalized intersections throughout Oxnard were reduced by 7% and injury crashes were reduced by 29%. Right-angle crashes, those most associated with red light violations, were reduced by 32%; right-angle crashes involving injuries were reduced by 68%.\n Because red light cameras can be a permanent component of the transportation infrastructure, crash reductions attributed to camera enforcement should be sustainable." ]

[ "12909492", "22314873", "20883991" ]

[ "Comparison of a levonorgestrel-releasing intrauterine device versus expectant management after conservative surgery for symptomatic endometriosis: a pilot study.", "Postoperative levonorgestrel-releasing intrauterine system for pelvic endometriosis-related pain: a randomized controlled trial.", "Postoperative medical treatment of chronic pelvic pain related to severe endometriosis: levonorgestrel-releasing intrauterine system versus gonadotropin-releasing hormone analogue." ]

[ "To determine whether the frequency and severity of dysmenorrhea are reduced in women with symptomatic endometriosis in whom a levonorgestrel-releasing intrauterine device (Lng-IUD) is inserted after operative laparoscopy compared with those treated with surgery only.\n Open-label, parallel-group, randomized, controlled trial.\n A tertiary care and referral center for patients with endometriosis.\n Parous women with moderate or severe dysmenorrhea undergoing first-line operative laparoscopy for symptomatic endometriosis.\n Randomization to immediate Lng-IUD insertion or expectant management after laparoscopic treatment of endometriotic lesions. Proportions of women with recurrence of moderate or severe dysmenorrhea in the two study groups 1 year after surgery and overall degree of satisfaction with treatment. Moderate or severe dysmenorrhea recurred in 2 of 20 (10%) subjects in the postoperative Lng-IUD group and 9/20 (45%) in the surgery-only group. Thus, a medicated device inserted postoperatively will prevent the recurrence of moderate or severe dysmenorrhea in one out of three patients 1 year after surgery. A total of 15/20 (75%) women in the Lng-IUD group and 10/20 (50%) in the expectant management group were satisfied or very satisfied with the treatment received.\n Insertion of an Lng-IUD after laparoscopic surgery for symptomatic endometriosis significantly reduced the medium-term risk of recurrence of moderate or severe dysmenorrhea.", "To estimate the effectiveness of a postoperative levonorgestrel-releasing intrauterine system for relieving pelvic pain in patients with endometriosis.\n A double-blind randomized controlled trial was conducted in 55 patients with endometriosis and moderate-to-severe dysmenorrhea (visual analog scale, greater than 50 mm) undergoing laparoscopic conservative surgery. After surgery, patients were randomized to a levonorgestrel-releasing intrauterine system (n=28) or expectant management (n=27) group. Primary outcome was the change of dysmenorrhea visual analog scale. Secondary outcomes included changes of pelvic pain and dyspareunia visual analog scale, Short Form-36 score, and adverse effects.\n The two groups were comparable in age, body mass index, parity, and baseline pain scores. At 12 months, the levonorgestrel-releasing intrauterine system group had a significantly lower median value of dysmenorrhea and noncyclic pelvic pain score. Compared with the control group, the levonorgestrel-releasing intrauterine system group had greater reduction in dysmenorrhea visual analog scale (-81.0 compared with -50.0 mm, P=.006) and pelvic pain visual analog scale (-48.5 compared with -22.0 mm, P=.038) but a comparable reduction in dyspareunia visual analog scale (-15.0 compared with -19.0 mm, P=.831). Two patients in levonorgestrel-releasing intrauterine system group (7.4%) and nine in the expectant management group (39.1%) had recurrent dysmenorrhea within 1 year postoperatively (P=.014). Number-needed-to-treat to prevent one case with recurrent dysmenorrhea within the first year was three cases. The Short Form-36 scores improved in the levonorgestrel-releasing intrauterine system group but did not change in the expectant management group. There was no serious adverse event during the study period.\n The levonorgestrel-releasing intrauterine system is effective and well accepted for long-term therapy after conservative surgery for patients with moderate to severe pain related to endometriosis. It can improve the patient's quality of life, including physical and mental health.", "To compare efficacy of the levonorgestrel-releasing intrauterine system (LNG-IUS; Mirena) with depot GnRH analogue (GnRH-a; gosareline acetate; Zoladex) on endometriosis-related chronic pelvic pain (CPP) in patients with severe endometriosis during 12 months.\n Prospective, randomized, controlled study.\n The reproductive endocrinology unit of a tertiary, research and education hospital.\n Forty women with severe endometriosis (revised The American Fertility Society [AFS] classification >40) and endometriosis-related CPP and control groups were enrolled in the study.\n The patients were treated with either LNG-IUS (n = 20) or GnRH-a (n = 20). The GnRH-a dose was repeated every 4 weeks for 24 weeks.\n Scores of CPP were evaluated using a visual analogue scale (VAS) and total endometriosis severity profile (TESP).\n The TESP score decreased in the LNG-IUS group at first, third, and sixth month follow-up visits, whereas at the 12th month follow-up visit, the TESP scores were increased to values similar to pretreatment values. Although the VAS score had no significant alteration during the follow-up period in the LNG-IUS group, the GnRH-a group showed a significant decrease in the VAS score and TESP score at the end of 1 year. The LNG-IUS treatment showed a lower patient satisfaction.\n Both treatment modalities showed comparable effectiveness in the treatment of CPP-related endometriosis.\n Copyright © 2011 American Society for Reproductive Medicine. Published by Elsevier Inc. All rights reserved." ]

[ "14584871", "11966926", "11288794", "15766369", "17137468", "18018467", "9287060" ]

[ "Effect of non-surgical periodontal therapy on glycemic control in patients with type 2 diabetes mellitus.", "Comparative evaluation of adjunctive oral irrigation in diabetics.", "Clinical and radiological improvement of periodontal disease in patients with type 2 diabetes mellitus treated with alendronate: a randomized, placebo-controlled trial.", "The effect of improved periodontal health on metabolic control in type 2 diabetes mellitus.", "Does periodontal care improve glycemic control? The Department of Veterans Affairs Dental Diabetes Study.", "Effect of non-surgical periodontal therapy on patients with type 2 diabetes mellitus.", "Treatment of periodontal disease in diabetics reduces glycated hemoglobin." ]

[ "The literature suggests that an alteration in glucose metabolism occurs as a result of antibacterial periodontal therapy. The objective of this study was to monitor the effect of non-surgical periodontal therapy on glycemic control in patients with type 2 diabetes mellitus (DM).\n Thirty type 2 DM subjects with periodontitis were randomly divided into two groups. Group 1 (G1), 15 subjects, received one-stage full-mouth scaling and root planing (FMSRP) plus amoxicillin/clavulanic acid 875 mg; group 2 (G2), 15 patients, received only FMSRP. At baseline and after 3 months, the glycated hemoglobin (HbA1c) values, fasting glucose, and clinical parameters (with computerized probing and individualized acrylic stents) were recorded. Following therapy, the subjects were enrolled in a 2-week interval maintenance program for 3 months.\n After treatment, both groups showed clinical improvements. A probing depth (PD) reduction of 0.8 +/- 0.6 mm (P < 0.05) occurred in G1 and 0.9 +/- 0.4 mm in G2 (P < 0.05), but there were no significant changes in attachment level. Treatment reduced the HbA1c values after the 3-month observation period in both groups; however, the reduction in HbA1c values for the G2 group was statistically significant, but not for the G1 group. The changes in fasting glucose levels were not significant for either group.\n Periodontal therapy improved glycemic control in patients with type 2 DM in both groups; however, the reduction in HbA1c values reached statistical significance only in the group receiving scaling and root planing alone [correction].", "The purpose of this study was to assess the response of diabetics to scaling and root planing treatment and subgingival oral irrigation as adjunctive therapy.\n A total of 52 type 1 and 2 diabetics (mean age 51.3+/-14) with adult periodontitis were randomized to two groups. Treatment included ultrasonic scaling and scaling and root planing in both groups (control and test) plus subgingival water irrigation 2x daily for the test group. Assessments were made prior to and at 6 and 12 weeks after treatment. Parameters measured were modified gingival index (MGI), probing pocket depth (PPD), plaque index (PI), clinical attachment level (CAL), and bleeding on probing (BOP). Systemic measurement of Reactive Oxygen Species (ROS) generation, cytokines (TNF-alpha, IL-1beta, IL-10, and PGE2), and glycated hemoglobin (HbA1C).\n After treatment, analysis of data showed that both groups had clinical and systemic improvement. The test group had a statistically significant reduction for MGI, PI, and BOP compared to controls (p<0.03) at 12 weeks and for ROS generation at 12 weeks (p<0.012). Unlike controls, systemic analysis of cytokines showed a statistically significant reduction from baseline for IL-1beta at 6 weeks and PGE2 at 6 and 12 weeks (p<0.05) within test group.\n These results suggest that scaling and root planing and adjunctive therapy may be of value in establishing a healthy periodontium in diabetics.", "Alendronate (ALN) is an aminobisphosphonate commonly used for osteoporosis in postmenopausal women. We studied the effect of ALN on bone loss prevention in type 2 diabetes mellitus patients with periodontal disease.\n In a controlled double-blind, randomized study we evaluated prospectively diabetic patients paired by gender and years since diagnosis for 6 months. The study included 40 patients (20 men and 20 women), 50 to 60 years old, with more than 5 years since diagnosis of diabetes and established periodontitis. They were randomly allocated to alendronate (10 mg/daily) or placebo treatment for 6 months. The endpoints of treatment were: the distance between the alveolar bone border and the cemento-enamel-junction (CEJ) evaluated by means of digital radiographic imaging, a biochemical marker of bone resorption (urine N-telopeptide) (Ntx), and periodontal parameters. Metabolic control was assessed at baseline and after 6 months.\n Baseline and 6-month glycated hemoglobin levels were similar in both groups. Alendronate induced a significant decrease in NTx at 6 months (P = 0.006). Periodontal parameters improved in both groups. However, they were significantly better for the ALN treated group. Alveolar bone border-CEJ distance increased in the placebo, but decreased in the ALN group (P = 0.0003).\n In type-2 diabetic patients, alendronate induced more improvement in alveolar bone crest height than control therapy. No differences in urinary N-telopeptide or glycated hemoglobin were observed in this short-term randomized controlled pilot trial.", "The aim of the present study was to investigate the effect of improved periodontal health on metabolic control in type 2 diabetes mellitus (DM) patients.\n Fourty-four patients with type 2 DM were selected. Subjects were randomly assigned into two groups. Data collection: Plaque index (PI), gingival index (GI), probing pocket depth (PPD), clinical attachment levels (CALs), gingival recession (GR) and bleeding on probing (BOP) were recorded at baseline at 1st and 3rd months. Fasting plasma glucose (FPG), 2-h post-prandial glucose (PPG), glycated haemoglobin (HbA1c), total cholesterol (TC), triglyceride (TG), HDL-cholesterol, LDL-cholesterol and microalbuminure were analysed at baseline, 3 months following the periodontal therapy. The treatment group received full-mouth scaling and root planing whereas the control group received no periodontal treatment.\n A statistically significant effect could be demonstrated for PI, GI, PPD, CAL and BOP for the treatment group. HbA1c levels in the treatment group decreased significantly whereas the control group showed a slight but insignificant increase for this parameter.\n The results of our study showed that non-surgical periodontal treatment is associated with improved glycaemic control in type 2 patients and could be undertaken along with the standard measures for the diabetic patient care.\n Copyright 2005 Blackwell Munksgaard.", "Report results of a randomized-clinical trial of the efficacy of periodontal care in the improvement of glycemic control in 165 veterans with poorly controlled diabetes over 4 months.\n Outcomes were change in Haemoglobin A1c (HbA1c) in the Early Treatment versus untreated (Usual Care) groups and percent of participants with decreases in HbA1c. Analyses included simple/multiple variable linear/logistic regressions, adjusted for baseline HbA1c, age, and duration of diabetes.\n Unadjusted analyses showed no differences between groups. After adjustment for baseline HbA1c, age, and diabetes duration, the mean absolute HbA1c change in the Early Treatment group was -0.65% versus -0.51% in the Usual Care group (p=0.47). Adjusted odds for improvement by 0.5% in the Early Treatment group was 1.67 (95% confidence interval: 0.84, 3.34, p=0.14). Usual Care subjects were twice as likely to increase insulin from baseline to 4 months (20% versus 11%, p=0.12) and less likely to decrease insulin (1% versus 6%, p=0.21) than Early Treatment subjects. Among insulin users at baseline, more increased insulin in the Usual Care group (40% versus 21%, p=0.06).\n No significant benefit was found for periodontal therapy after 4 months in this study; trends in some results were in favour of periodontal treatment.", "The AIM of this study was to evaluate the effect of non-surgical therapy on clinical variables and glycemic control on type 2 diabetics with chronic periodontitis.\n Forty six type 2 diabetics with chronic periodontitis were randomized into two groups (group A and group B). Treatment included scaling and root planning for group A plus systematic use of doxycycline in both groups. Assessment was made prior to and 16 weeks following the therapy.\n Analysis of data showed that both groups had clinical and glycated hemoglobin (HbAlc) improvement after the treatment. Group A had a statistically significant reduction of plaque index and bleeding on probing scores compared with controls (P < 0.05) at 16 weeks.\n These results suggest that non-surgical therapy is of value in maintaining periodontal health and may be beneficial in reducing blood glucose level in type 2 diabetics with chronic periodontitis.", "Periodontal disease is a common infection-induced inflammatory disease among individuals suffering from diabetes mellitus. The purpose of this study was to assess the effects of treatment of periodontal disease on the level of metabolic control of diabetes. A total of 113 Native Americans (81 females and 32 males) suffering from periodontal disease and non-insulin dependent diabetes mellitus (NIDDM) were randomized into 5 treatment groups. Periodontal treatment included ultrasonic scaling and curettage combined with one of the following antimicrobial regimens: 1) topical water and systemic doxycycline, 100 mg for 2 weeks; 2) topical 0.12% chlorhexidine (CHX) and systemic doxycycline, 100 mg for 2 weeks; 3) topical povidone-iodine and systemic doxycycline, 100 mg for 2 weeks; 4) topical 0.12% CHX and placebo; and 5) topical water and placebo (control group). Assessments were performed prior to and at 3 and 6 months after treatment and included probing depth (PD), clinical attachment level (CAL), detection of Porphyromonas gingivalis in subgingival plaque and determination of serum glucose and glycated hemoglobin (HbA1c). After treatment all study groups showed clinical and microbial improvement. The doxycycline-treated groups showed the greatest reduction in probing depth and subgingival Porphyromonas gingivalis compared to the control group. In addition, all 3 groups receiving systemic doxycycline showed, at 3 months, significant reductions (P < or = 0.04) in mean HbA1c reaching nearly 10% from the pretreatment value. Effective treatment of periodontal infection and reduction of periodontal inflammation is associated with a reduction in level of glycated hemoglobin. Control of periodontal infections should thus be an important part of the overall management of diabetes mellitus patients." ]

[ "6294517", "1783915" ]

[ "Intensive immunosuppression in progressive multiple sclerosis. A randomized, three-arm study of high-dose intravenous cyclophosphamide, plasma exchange, and ACTH.", "Intense immunosuppression in chronic progressive multiple sclerosis: the Kaiser study." ]

[ "Fifty-eight patients with severe, progressive multiple sclerosis were prospectively randomized to one of three treatments: 20 received intravenous ACTH, 20 received high-dose intravenous cyclophosphamide plus ACTH, and 18 were placed on a regimen consisting of plasma exchange, low-dose oral cyclophosphamide, and ACTH. The three groups were similar in age, sex, duration and type of disease, and degree of disability. Before treatment and six months and one year after treatment, a disability-status score, ambulation index, and functional-status score were determined, and a quantitative neurologic examination was performed. In the ACTH group, the number of patients stabilized or improved was 8 of 20 at six months and 4 of 20 at one year; in the cyclophosphamide-ACTH group, 18 of 20 at six months and 16 of 20 at one year; and in the plasma exchange group, 11 of 18 at six months and 9 of 18 at one year. High-dose cyclophosphamide plus ACTH was most effective in halting progression of the disease at both 6 and 12 months (at 12 months, cyclophosphamide-ACTH vs. ACTH, P = 0.0004; cyclophosphamide-ACTH vs. plasma exchange, P = 0.087). Thus, progressive multiple sclerosis may be stabilized by short-term, intensive immunosuppression with cyclophosphamide plus ACTH.", "The value of a short course of intensive immunosuppression with cyclophosphamide in stabilising chronic progressive multiple sclerosis (MS) was examined in a randomised single-blinded, placebo-controlled clinical trial. Forty two patients, from the Kaiser Permanente Medical Care Program, Northern California, were studied. Twenty two patients received a short course of cyclophosphamide in an outpatient neurology clinic until their leucocyte counts fell below 4000/mm3, and 20 patients received folic acid. Level of disability, impairment of functional systems, and performance of social roles were assessed before randomisation and reassessed 12, 18, and 24 months after therapy. In both the cyclophosphamide and folic acid groups, the mean level of disability increased from the baseline examination to the 12 month follow up examination (the primary endpoint) by 0.5 on Kurtzke's Expanded Disability Status Scale, indicating similar disease progression in the two groups. Although immunosuppression therapy can be safely administered to MS patients in an outpatient clinic, evidence of substantial benefits was not found." ]

[ "7452872", "1651304", "6389779" ]

[ "Cranial irradiation in cancer of the lung of all cell types.", "Prophylactic cranial irradiation for lung cancer patients at high risk for development of cerebral metastasis: results of a prospective randomized trial conducted by the Radiation Therapy Oncology Group.", "Role of elective brain irradiation during combined chemoradiotherapy for limited disease non-small cell lung cancer." ]

[ "The Veterans Administration Lung Group conducted a prospective study of irradiation for subclinical brain metastases in patients with inoperable carcinoma of the lung between 1975 and 1978. Patients were randomized to receive whole-brain irradiation (2,000 rads in two weeks) or no brain treatment, and to receive one of two regimens of thoracic irradiation. Three hundred twenty-three patients with normal radionuclide brain scans were able to be evaluated. The rate of clinical brain metastasis was 26% for patients with small cell carcinoma vs 10% for the \"non-small-cell\" group. A statistically insignificant decrease in the rate of brain metastasis was found among irradiated patients with small cell carcinoma. The frequency of brain metastasis in the non-small-cell patients was reduced from 13% to 6% by irradiation. Prophylactic cranial irradiation can decrease morbidity from non-small-cell carcinoma of the lung.", "Beginning in February 1984, 187 evaluable patients with adenocarcinoma or large cell carcinoma of the lung clinically confined to the chest were randomized to receive either conventionally fractionated thoracic irradiation alone or thoracic irradiation with concurrent, prophylactic cranial irradiation. The study population included 161 patients treated for medically or surgically inoperable primary cancers, and 26 patients undergoing adjuvant postoperative mediastinal irradiation following attempted curative resection of primary cancers found to have metastasized to hilar or mediastinal lymph nodes. Elective brain irradiation was not effective in preventing the clinical appearance of brain metastases, although the time to develop brain metastases appears to have been delayed. Eighteen of 94 patients (19%) randomized to chest irradiation alone have developed brain metastases as opposed to 8/93 patients (9%) randomized to receive prophylactic cranial irradiation (p = .10). No survival difference was observed between the treatment arms. Among the 26 patients undergoing prior resection of all gross intrathoracic disease, brain metastases were observed in 3/12 patients (25%) receiving adjuvant chest irradiation alone, compared to none of 14 receiving prophylactic cranial irradiation (p = .06). In the absence of fully reliable therapy for the primary disease, and without effective systemic therapy preventing dissemination to other, extrathoracic sites, prophylactic cranial irradiation for inoperable non-small cell lung cancer cannot be justified in routine clinical practice. Further investigation in the adjuvant, postoperative setting may be warranted.", "We have studied the clinical impact of elective brain irradiation (EBI) in patients with locally advanced, non-small cell lung cancer (LA-NSC). All patients received combination chemotherapy (cyclophosphamide + doxorubicin (Adriamycin) + cisplatin = CAP) or CAP plus radiotherapy as the initial treatment for their active tumor or as an adjuvant therapy. Of 97 evaluable patients, 46 were randomized to receive EBI (3 000 rad in 10 fractions given over two weeks). The characteristics of both groups were comparable by sex, age, performance status, pretherapy weight loss, histologic cell type, clinical staging, and type of prior therapy. EBI significantly decreased the incidence of central nervous system (CNS) metastasis in the treated group compared to the control group (4% vs 27%, p = .002). CNS involvement occurred in the treated group after failure at other sites whereas 12 of 14 control patients had CNS metastases as the first site of relapse. EBI decreased the incidence of CNS metastasis in all prognostic categories. Using multivariate analysis, the beneficial effect was shown to be significant in females, patients with good performance status, weight loss less than 6%, squamous cell histology, state III disease or no prior therapy. EBI significantly increased CNS metastasis-free interval with a beneficial effect that was significant in males, patients with weight loss less than 6%, squamous cell histology or responders. Although no survival benefit was observed for the treated group because of the adverse effect from other relapses, EBI will become more important as better treatment programs are developed.(ABSTRACT TRUNCATED AT 250 WORDS)" ]

[ "7227377", "9260237", "346147", "10603129", "7488812", "9035508", "16540560", "8482290", "3933645", "3335948", "9323286", "10940745", "109598", "10972687", "12776266" ]

[ "Alternate-day prednisone is more effective than intermittent prednisone in frequently relapsing nephrotic syndrome. A report of \"Arbeitsgemeinschaft für Pädiatrische Nephrologie.", "A controlled study of deflazacort in the treatment of idiopathic nephrotic syndrome.", "Idiopathic nephrotic syndrome: prevention of early relapse.", "Prolonged versus standard prednisolone therapy for initial episode of nephrotic syndrome.", "Short versus long initial prednisone treatment in steroid-sensitive nephrotic syndrome in children.", "[Initial therapy of primary nephrotic syndrome in children: evaluation in a period of 18 months of two prednisone treatment schedules. Chilean Co-operative Group of Study of Nephrotic Syndrome in Children].", "Initial treatment of idiopathic nephrotic syndrome in children: prednisone versus prednisone plus cyclosporine A: a prospective, randomized trial.", "Long versus standard prednisone therapy for initial treatment of idiopathic nephrotic syndrome in children. Arbeitsgemeinschaft für Pädiatrische Nephrologie.", "Controlled trial of methylprednisolone pulses and low dose oral prednisone for the minimal change nephrotic syndrome.", "Intermittent versus long-term tapering prednisolone for initial therapy in children with idiopathic nephrotic syndrome.", "Single- versus divided-dose prednisolone therapy for relapses of nephrotic syndrome.", "Increased maintenance corticosteroids during upper respiratory infection decrease the risk of relapse in nephrotic syndrome.", "Nephrotic syndrome in children: a randomized trial comparing two prednisone regimens in steroid-responsive patients who relapse early. Report of the international study of kidney disease in children.", "Older boys benefit from higher initial prednisolone therapy for nephrotic syndrome. The West Japan Cooperative Study of Kidney Disease in Children.", "A randomized study of two long-course prednisolone regimens for nephrotic syndrome in children." ]

[ "nan", "Forty patients with steroid-dependent idiopathic nephrotic syndrome (INS), a mean follow-up of 5.5 years, and a mean number of relapses of ten were blindly assigned to either deflazacort (DFZ) (n = 20) or prednisone (PDN) (n = 20) according to a ratio of equivalence of DFZ/ PDN = 0.8. This treatment was given for 1 year. The number of relapses was significantly lower in patients receiving DFZ. After 1 year, 12 remained in remission with DFZ compared with 2 with PDN. Growth velocity was not different in the two groups. Bone mineral content, assessed by quantitative computed tomography of L1 L2 vertebrae, decreased after 1 year by 6% in the DFZ group versus 12% in the PDN group (NS). The mean body weight increase of +3.9 +/- 4.1 kg in the PDN group was higher than that of the DFZ group, +1.7 +/- 2.8 kg (P = 0.06). Cushingoid symptoms tended to be less after 12 months in the DFZ group. In conclusion, this study shows that DFZ was more effective than PDN in limiting relapses in steroid-dependent INS, and that cushingoid symptoms, weight gain, and decrease in bone mineral content tended to be less marked with this drug than with PDN.", "nan", "We have examined, in a prospective randomized controlled trial, the effect of 8- and 16-week initial steroid treatment on the course of idiopathic nephrotic syndrome (INS). Patients with a first episode of INS were randomized to receive standard 8-week prednisolone (2 mg/kg daily for 4 weeks, then 1.5 mg/kg on alternate days for 4 weeks) or prolonged 16-week prednisolone treatment (2 and 1.5 mg/kg daily each for 4 weeks, then 1.5 and 1 mg/kg on alternate days each for 4 weeks). Relapses were treated with prednisolone, 2 mg/kg daily for 2 weeks, then 1.5 mg/kg on alternate days for 4 weeks. Of 45 patients, 23 received standard therapy and 22 prolonged therapy. The mean duration of follow-up was 29.2 and 27.3 months in the standard and prolonged treatment groups, respectively. The time to first relapse was longer in the prolonged treatment (mean 222.2 days, median 120.0 days) than the standard group (mean 134.3 days, median 96.5 days). The percentage of patients with no relapse at 6 and 12 months after prednisolone withdrawal was 40.9% and 27.3% in the prolonged treatment and 21.7% and 8.7% in the standard groups, respectively. The inability to show statistically significant differences between the two groups was probably related to the small number of patients studied. Prolonged therapy did not affect the subsequent relapse rates and proportion of patients with frequent relapses and steroid dependence. The mean dose of prednisolone received, for the initial episode and relapses during the next year, was higher and associated with significant steroid toxicity in the prolonged treatment group. Our findings suggest that 16-week prednisolone treatment for the initial episode of INS may delay occurrence of the first relapse, but results in significant side effects. Prolongation of initial therapy may be useful in developing countries where frequent infections often induce early relapses.", "A total of 184 children aged, 13 months to 11 years, suffering from their first attack of steroid-responsive nephrotic syndrome were included in a randomized study. They were treated according to three treatment protocols. All children received 1-2 mg of prednisone/kg body weight/day (up to 80 mg daily) for 4 weeks, and thereafter 1 mg/kg body weight/48 h for the next 4 weeks. Treatment was discontinued at this point in 44 children (protocol A); in 68 (protocol B) the dose was reduced by 25% each week, tapering off to 0 at the end of the third month, while in 72 children (protocol C), after the first 2 months of initial treatment the dose was reduced by 25% each month and tapered off to 0 by the end of the sixth month. All patients completed a 2-year follow-up period after withdrawal of prednisone. Treatment results were expressed as: percentage of children relapse-free within the first 6 months and 2 years after withdrawal of treatment, and average number of relapses per patient per year. The best results were obtained in children who had been treated for 6 months; 65.3% of them remained relapse-free within the first 6 months and 50% over the entire 2-year follow-up period; the number of relapses per patient per year in this group was 0.49. The respective values for children treated 2 and 3 months were: 36.4% and 32.4% for the 6-month period; 27.3% and 20.6% for the 2-year period; the numbers of relapses per patient per year were 0.79 and 0.77, respectively.(ABSTRACT TRUNCATED AT 250 WORDS)", "Ninety six patients aged from 6 months to 15 years and were admitted to Chilean hospitals with the diagnosis of primary nephrotic syndrome in a period of 30 months. These patients were randomly separated in two groups, group A received prednisone for 8 weeks and group B received the same drug during 12 weeks. All patients were evaluated at 6, 12 and 18 months after the end of treatment. The moment and number of relapses per patient, accumulated percentage of relapses, relapse rate per 100 patients, total number of relapses and complications were assessed. Frequent relapsers were subjected to a kidney biopsy, leaving in the protocol only those patients that had minimal changes. Patients resistant or dependent to steroid therapy were discarded. Thus we report the results of 56 treated patients followed during 18 months. No differences in analyzed parameters were observed between the two treatment groups. It is concluded that these preliminary results do not support the prolongation of prednisone treatment in children with primary nephrotic syndrome.", "Previous studies of the Arbeitsgemeinschaft für Pädiatrische Nephrologie in children with steroid-sensitive nephrotic syndrome have shown that the length of initial prednisone therapy has an impact on the subsequent relapse rate. The aim of this randomized, prospective, multicenter study was to reduce the number of relapses further by increasing the initial immunosuppression: Patients with an initial attack of nephrotic syndrome were randomly allocated to treatment with 6 wk of 60 mg/m(2) per d prednisone followed by 6 wk of 40 mg/m(2) per 48 h (Pred group) or to the same prednisone treatment plus 8 wk of cyclosporine (Pred+CsA group). The primary end point was first relapse; follow-up was truncated at 2 yr. In the Pred+CsA group (n = 49 patients), the first relapse occurred later compared with the Pred group (n = 55 patients) (median 22.8 versus 12.5 mo). After 6 mo, 10.4% of patients in the Pred+CsA group experienced a first relapse versus 31.5% in the Pred group (P = 0.01); after 1 yr, 36.5 versus 51% (P = 0.15); and after 2 yr, 51 versus 50%. The mean relapse rate per patient was 0.12 versus 0.57 after 6 mo (P = 0.01), 0.63 versus 1.03 after 1 yr (P = 0.02), and 1.03 versus 2.06 after 2 yr (not significant). The significant benefit for adding CsA was lost after 9 to 12 mo. GFR remained unchanged. The subsequent treatment rate with cyclophosphamide was lower in the CsA group (five versus 12 patients) after 2 yr. With the use of logistic regression statistics, children who were younger than 7 yr show a significantly better sustained remission rate with initial CsA treatment for the 2-yr observation time (P = 0.03). It remains questionable, however, whether the intensified initial treatment with CsA could be recommended generally.", "Two regimens of steroid treatment for the initial attack of idiopathic nephrotic syndrome (NS) in children were compared in a controlled prospective multi-centre study. Long prednisone therapy consisted of 60 mg/m2 per 24 h for 6 weeks, followed by alternate day 40 mg/m2 per 48 h for 6 weeks. The standard prednisone therapy was 60 mg/m2 per 24 h for 4 weeks, followed by 40 mg/m2 per 48 h for 4 weeks. A total of 71 children with an initial attack of idiopathic NS were allocated at random to the two groups. The cumulative rate of patients with sustained remissions after 2 years was significantly higher after the long course than after the standard treatment (49% vs 19%, P = 0.0079). The mean relapse rate per patient at intervals of 3, 6 and 12 months was lower in the long-course prednisone group than in the standard prednisone group, and the proportion of children with frequent relapses during any subsequent 6 months period was lower in the long-course group than in the standard group (29% vs 57%, P = 0.03). Mild side-effects of corticosteroid therapy were observed more frequently after long-course prednisone treatment. It is concluded that long-course prednisone therapy of the initial attack of steroid responsive NS is preferable to the standard regimen because it reduces the rate of subsequent relapses without increasing the risk for severe steroidal side-effects.", "In a multicentre, randomised, prospective trial 89 patients (67 children and 22 adults) with the minimal change nephrotic syndrome were treated with three intravenous pulses of methylprednisolone followed by low dose oral prednisone for six months (group given methylprednisolone) or with high dose oral prednisone for four weeks followed by low dose oral prednisone for five months (control group). Five patients in the group given methylprednisolone and one in the control group did not respond initially. The time to response was shorter in children treated with methylprednisolone. No significant differences between the two groups were observed in the number of patients who relapsed or number of relapses per patient per year. Patients given methylprednisolone tended to relapse earlier than patients in the control group. Side effects related to treatment were significantly fewer in the group given methylprednisolone than in the control group. These data suggest that a short course of methylprednisolone pulses followed by low dose oral prednisone is only marginally less effective than a regimen of high dose oral steroids but can improve the ratio of risk to benefit associated with treatment of the minimal change nephrotic syndrome.", "Forty-six children with steroid-responsive nephrotic syndrome were randomly allocated to receive two different prednisolone regimens for initial therapy. Twenty-nine children (group 1) received an intermittent regimen (60 mg/m2/day for 4 weeks, followed by 40/mg/m2/day on 3 days a week for 4 weeks); 17 children (group 2) had a long-term regimen (60 mg/m2/day for 4 weeks, followed by the same dose on alternate days for 4 weeks and the doses tapered by 10 mg/m2, given on alternate days every 4 weeks for 5 months). There was no difference between the two groups in the regimen used to treat relapses, steroid responsiveness, number of patients with relapses, and frequency of toxic reactions to steroids. However, the number of patients with a relapse within 6 months after initial therapy and the number of those with frequent relapses or steroid dependence were significantly higher in group 1 than in group 2 (P less than 0.05 for both). The data indicate that the long-term tapering regimen appears to be both safe and preferable to the intermittent regimen for initial therapy in children with idiopathic nephrotic syndrome.", "Relapses of nephrotic syndrome are usually treated with prednisolone, initially in three to four daily divided doses. The divided-dose regimen may cause poor patient compliance and greater adrenal suppression. In a prospective randomized controlled trial, we compared the efficacy of prednisolone in inducing remission of nephrotic syndrome, when given either as a single dose or in divided doses. Patients with steroid-responsive nephrotic syndrome with relapse were randomized to receive prednisolone 2 mg/kg per day, either as a single morning dose or in three divided doses for 2 weeks, followed by 1.5 mg/kg on every alternate day for 4 weeks. Parents tested the urine for protein daily until remission (nil proteinuria for 3 consecutive days). The duration between initiation of treatment and achievement of remission was recorded. Of 106 patients, 94 (47 each in single-dose and divided-dose groups) completed the study. The patients in the two groups were similar in relation to age, sex, number of relapses in the preceding year, and blood levels of creatinine, albumin, and cholesterol. The mean time for achievement of remission in the single- and divided-dose groups was 8.6 and 8.5 days, respectively (P = 0.94, power 96%). After 9 months' follow-up, there were no differences in the frequency of relapses and cumulative dose of prednisolone received in the two groups. The observations suggest that prednisolone administered in a single daily dose or in divided doses is equally effective in inducing remission in patients with relapsing nephrotic syndrome.", "Relapses are common in children with idiopathic nephrotic syndrome, and this prospective study looks into the possibility of decreasing the frequency of relapses in a selected group of such patients. The study includes 36 children with a steroid-dependent, relapsing nephrotic syndrome on a maintenance prednisone therapy of about 0.5 mg/kg every other day. They were prospectively divided into two groups with comparable age and sex distribution and the number of those who had previously received cyclophosphamide therapy. Group 1 patients were advised to take daily prednisone for 5 days, starting at the time of the onset of an upper respiratory tract infection (URI). No such advice was given to those in group 2, and they remained on alternate-day prednisone during URI. At the end of a 2-year follow-up period, the total number of relapses in group 1 was 40 with a mean of 2.2 +/- 0.87 per patient as compared with 99 with a mean of 5.5 +/- 1.33 per patient in group 2 (p = 0.04). We conclude that an increased maintenance prednisone during URI helps decrease significantly the number of relapses in those on alternate-day therapy.\n Copyright 2000 S. Karger AG, Basel", "Fifty-four children with steroid-responsive nephrotic syndrome relapsing within 6 months of their initial response were randomly allocated to receive two different regimens of prednisone therapy. The test regimen differed from the standard prednisone relapse regimen used by the International Study of Kidney Disease in Children in that the total dosage was about double, and the duration of daily therapy (8 weeks vs. a mean of 12 days) as well as the total duration of treatment (8 weeks vs. a mean of approximately 6 weeks) was longer. The proportion of patients relapsing during treatment was significantly smaller (8% vs. 40%) and the length of remission following treatment was significantly longer (3.27 vs. 1.48 months) in the test group. All patients in both groups relapsed by 8 months. During a period of approximately 6 months after this relapse, neither the frequency of relapses nor the mean number of days of proteinuria differed significantly. Opinions of participants in this multicenter trial varied concerning whether these statistically significant differences clinically justified exposing patients to the more intensive treatment regimen. However, all agreed that neither form of treatment was satisfactory in terms of preventing subsequent relapses.", "A long course of the initial prednisolone therapy has been shown to be more effective than standard-course therapy in reducing relapse rates in children with idiopathic nephrotic syndrome, but it is commonly accompanied by corticosteroid toxicities. There has been no study on prednisolone dosage for the effective treatment of nephrotic syndrome.\n Sixty-eight children (42 boys and 26 girls) with an initial attack of nephrotic syndrome were randomly allocated into two different long-course treatment groups. Patients in Group 1 received a daily prednisolone dose of 60 mg/m2 for six weeks, followed by an alternate-day dose of 40 mg/m2 for six weeks. Patients in Group 2 had a daily dose of 40 mg/m2 instead of 60 mg/m2.\n Four children in each group did not respond within six weeks. Group 1 was associated with a significantly earlier response but more frequent corticosteroid toxicities than Group 2. Boys in Group 1 had a higher rate of sustained remission than boys in Group 2 (P = 0.0073), especially boys four years old or more (P = 0.0027), but girls did not show a significant difference (P = 0.863). Boys four years old or more in Group 1 had a course of frequent relapsing less often than those in Group 2 (2 of 13 vs. 6 of 8, P = 0.0075).\n These findings indicate that efficient prednisolone doses may vary between sexes and ages, and that a higher initial prednisolone therapy may be of greater benefit to older boys.", "Long-course prednisolone regimens have been shown to be more effective than short-course regimens in sustaining remission of nephrotic syndrome in children. However, the most beneficial approach among the long-course regimens remains unknown.\n Seventy-three children with new-onset nephrotic syndrome were allocated at random to the two long-course regimens and followed up for 2 years. Group A was administered prednisolone at a daily dose of 60 mg/m2 for 6 weeks, followed by an alternate-day dose of 40 mg/m2 for 6 weeks (the long daily regimen). Group B was administered the same daily dose for 4 weeks, followed by an alternate-day dose of 60 mg/m2 for 4 weeks, and doses were tapered by 10 mg/m2 every 4 weeks (the long alternate-day regimen).\n Group B had a lower incidence of corticosteroid toxicities than group A during the initial treatment. Kaplan-Meier analysis of the sustained remission rate of the two treatment groups showed a marginally significant difference (P = 0.069) and showed a significant difference when patients were stratified for age of disease onset (P = 0.048). In a subgroup of younger children (<4 years at onset), group B had a greater rate of sustained remission (P < 0.01) and fewer children with frequent relapses (P < 0.05) than group A, whereas in older children (> or =4 years at onset), both groups had similar good sustained remission rates.\n These findings collectively indicate that the long alternate-day regimen may be more beneficial, with less corticosteroid toxicities, than the long daily regimen, and children with younger age at disease onset may be susceptible to relapse and especially benefit from the long alternate-day regimen for sustaining remission of the disease." ]

[ "9121851", "758386" ]

[ "Chest physiotherapy and post-extubation atelectasis in infants.", "Postextubation atelectasis: a retrospective review and a prospective controlled study." ]

[ "We investigated the role of chest physiotherapy (CPT) in preventing post-extubation atelectasis (PEA) in infants. Sixty-three infants who were admitted to the neonatal intensive care unit and intubated for more than 24 hours and who showed no evidence of atelectasis by chest x-ray prior to extubation were enrolled in the study. Infants were randomly assigned to 2-hourly CPT, 4-hourly CPT, or a no CPT group. Chest physiotherapy began immediately after extubation and consisted of postural drainage, bilateral chest vibration, and suctioning. A second chest x-ray was obtained on all infants 24 hours following extubation. The three groups were comparable in birth weight, gestational age, and duration of intubation. In the 24-hour period following extubation, the incidence of PEA was not statistically significant in the three groups (P = 0.33). Two infants in the 2-hourly CPT group were placed on nasal continuous positive airway pressure; two in each of the 2-hourly and the no CPT groups required re-intubation and intermittent positive pressure ventilation to treat symptomatic atelectasis. We conclude that post extubation chest physiotherapy as used in this study did not prevent atelectasis in extubated infants.", "To determine the role of chest physiotherapy in the prevention of postextubation atelectasis in neonates intubated for greater than 24 hours, a retrospective survey compared the incidence of this complication in a newborn intensive care unit prior to and following the institution of a routine of chest physiotherapy. Eight of 23 infants extubated developed atelectasis in the \"pre-physio\" period, whereas only one collapse occurred in 20 infants treated with a routine of physiotherapy at extubation (P less than 0.025). Subsequently a prospective controlled trial compared the use of a routine of physiotherapy at extubation with no physiotherapy. Eight of 21 infants not receiving physiotherapy developed postextubation atelectasis and none of 21 infants receiving physiotherapy developed atelectasis (P less than 0.01). Seventy-six percent of the collapses involved the right upper lobe. A vigorous program of chest physiotherapy, including postural drainage emphasizing the positions of the right upper lobe and chest vibrations, will significantly reduce the incidence of postextubation atelectasis." ]

[ "11264907", "11059502", "16884341", "16238507" ]

[ "HIV adolescents show improved immune function following massage therapy.", "The effects of massage therapy alone and in combination with other complementary therapies on immune system measures and quality of life in human immunodeficiency virus.", "Impact of a massage therapy clinical trial on immune status in young Dominican children infected with HIV-1.", "A randomized controlled trial of meditation and massage effects on quality of life in people with late-stage disease: a pilot study." ]

[ "HIV+adolescents (M CD4=466 mm3) recruited from a large urban university hospital's outpatient clinic were randomly assigned to receive massage therapy (n=12) or progressive muscle relaxation (n=12) two-times per week for 12 weeks. To assess treatment effects, participants were assessed for depression, anxiety and immune changes before and after treatment the 12 weeks treatment period. Adolescents who received massage therapy versus those who experienced relaxation therapy reported feeling less anxious and they were less depressed, and showed enhanced immune function by the end of the 12 week study. Immune changes included increased Natural Killer cell number (CD56) and CD56+CD3-. In addition, the HIV disease progression markers CD4/CD8 ratio and CD4 number showed an increase for the massage therapy group only.", "Determine effects of massage therapy alone and in combination with exercise or stress management-biofeedback treatment on enumerative immune measures, and quality of life in moderately immunocompromised human immunodeficiency virus (HIV) subjects.\n Randomized prospective controlled trial with 42 subjects randomly assigned to one of three treatment groups or a control group receiving standard care and intervention over a 12-week period.\n Academic medical center.\n Forty-two (42) subjects with HIV infection (40 males; 2 females; aged 27-50 years) met eligibility requirements of CD4+ lymphocyte cell count greater than 200 cells per microliter; no present or recent signs or symptoms of acquired immunodeficiency syndrome (AIDS), and were not hospitalized.\n A 45-minute overall body massage once per week; similar massage and supervised aerobic exercise 2 other days per week; similar massage and biofeedback stress management once per week; control receiving standard treatment.\n Changes in peripheral blood levels of CD4+ lymphocytes, CD8+ lymphocytes, CD4+/CD8+ lymphocyte ratio and natural killer cells; six dimension quality-of-life assessment.\n No significant changes (p > 0.05) were found in any enumerative immune measure. Significant (p < 0.05) differences for quality-of-life assessment were in health care utilization and health perceptions, favoring massage and stress management compared to massage only and controls.\n Massage administered once per week to HIV-infected persons does not enhance immune measures. Massage combined with stress management favorably alters health perceptions and leads to less utilization of health care resources. This suggests that HIV-infected persons receiving massage and stress management would tend to not overutilize health care services, thus possibly reducing health care costs.", "The effectiveness of massage therapy on immune parameters was evaluated in young Dominican HIV+ children without current access to antiretroviral therapies.\n Eligible children, who were followed at the Robert Reid Cabral Hospital (San Domingo, Dominican Republic), were randomized to receive either massage treatment or a control/friendly visit twice weekly for 12 weeks. Blood was drawn at baseline and following the 3-month intervention for determinations of CD4, CD8, and CD56 cell counts and percentage, along with activation markers (CD25 and CD69).\n Despite similar immune parameters at baseline in the two groups, significantly more of the control group exhibited a decline in CD4 cell count (>30%, p = 0.03), postintervention. The decrease was particularly evident in older (5-8 years) children in the control arm, who demonstrated a significant reduction in both CD4 and CD8 cell counts compared to massage-treated older children who remained stable or showed immune improvement. Additionally, a significant increase in CD4+CD25+ cells was observed over the 12-week trial in the massage-treated older children (p = 0.04) but not in the control group. In younger massage-treated children, (2-4 years old), a significant increase in natural killer cells was shown.\n Together these findings support the role for massage therapy in immune preservation in HIV+ children.", "Certain meditation practices may effectively address spiritual needs near end-of-life, an often overlooked aspect of quality of life (QOL). Among people subject to physical isolation, meditation benefits may be blunted unless physical contact is also addressed.\n To evaluate independent and interactive effects of Metta meditation and massage on QOL in people with acquired immunodeficiency syndrome (AIDS).\n Randomized controlled blinded factorial pilot trial conducted from November 2001 to September 2003.\n An AIDS-dedicated skilled nursing facility in New Haven, Connecticut.\n Fifty-eight residents (43% women) with late stage disease (AIDS or comorbidity).\n Residents were randomized to 1 month of meditation, massage, combined meditation and massage, or standard care. The meditation group received instruction, then self-administered a meditation audiocassette daily. A certified massage therapist provided the massage intervention 30 minutes per day 5 days per week.\n Changes on Missoula-Vitas QOL Index overall and transcendent (spiritual) scores at 8 weeks. Results: The combined group showed improvement in overall (p = 0.005) and transcendent (p = 0.01) scores from baseline to 8 weeks, a change significantly greater (p < 0.05) than the meditation, massage, and control groups.\n The combination of meditation and massage has a significantly favorable influence on overall and spiritual QOL in late-stage disease relative to standard care, or either intervention component alone." ]

[ "10576189", "15694090", "11814497", "15746667", "14526301", "12755528", "15951101", "16455695", "10329871", "17722318", "10960643", "8649699", "14616254", "11952465", "15104606", "11641677", "11499184", "10688506", "14562597", "12681871", "15327448", "14643034", "12504970", "17343543", "15733875", "12830603", "11212999", "11759980", "12512928", "12834947", "14586349", "16866794", "11430966", "15847879", "16929421", "18165400", "15284771", "12830602", "12548212" ]

[ "Randomized comparison of oral misoprostol and oxytocin for labor induction in term prelabor membrane rupture.", "A comparison of labor induction by oral and vaginal misoprostol.", "Oral and vaginal misoprostol compared with dinoprostone for induction of labor: a randomized controlled trial.", "Prospective randomized clinical trial of inpatient cervical ripening with stepwise oral misoprostol vs vaginal misoprostol.", "Oral misoprostol for premature rupture of membranes at term.", "A comparison between intravaginal and oral misoprostol for labor induction: a randomized controlled trial.", "A comparison of oral and vaginal misoprostol for induction of labor.", "Oral misoprostol for induction of labour at term: randomised controlled trial.", "A comparison of orally administered misoprostol with vaginally administered misoprostol for cervical ripening and labor induction.", "A comparison between single dose of 50 microg oral misoprostol and 25 microg vaginal misoprostol for labor induction.", "Oral misoprostol and intracervical dinoprostone for cervical ripening and labor induction: a randomized comparison.", "Cervical priming with oral misoprostol in pre-labor rupture of membranes at term.", "Oral misoprostol (100 microg) versus vaginal misoprostol (25 microg) in term labor induction: a randomized comparison.", "A comparison of two dosage regimens of oral misoprostol for labor induction at term.", "A randomised comparison of oral misoprostol and vaginal prostaglandin E2 tablets in labour induction at term.", "A comparison of various routes and dosages of misoprostol for cervical ripening and the induction of labor.", "Oral misoprostol vs. intravaginal prostaglandin E2 for preinduction cervical ripening. A randomized trial.", "Labour characteristics and uterine activity: misoprostol compared with oxytocin in women at term with prelabour rupture of the membranes.", "Vaginal misoprostol for induction of labour: a more effective agent than prostaglandin F2 alpha gel and prostaglandin E2 pessary.", "Ruptured membranes at term: randomized, double-blind trial of oral misoprostol for labor induction.", "Comparison of oral and vaginal misoprostol for induction of labor at term: a randomized controlled trial.", "Cervical ripening with oral misoprostol at term.", "Active management of term prelabour rupture of membranes with oral misoprostol.", "Induction of labor with oral misoprostol for premature rupture of membranes at term in women with unfavorable cervix: a randomized, double-blind, placebo-controlled trial.", "Oral misoprostol versus intracervical dinoprostone for induction of labor.", "Labour induction at term--a randomised trial comparing Foley catheter plus titrated oral misoprostol solution, titrated oral misoprostol solution alone, and dinoprostone.", "A comparison of oral and vaginal misoprostol for induction of labour at term: a randomised trial.", "A comparison between 50 mcg oral misoprostol every 4 hours and 6 hours for labor induction: a prospective randomized controlled trial.", "A comparison of 100 microg oral misoprostol every 3 hours and 6 hours for labor induction: a randomized controlled trial.", "Oral misoprostol vs. intravenous oxytocin for labor induction in women with prelabor rupture of membranes at term.", "The MisoPROM study: a multicenter randomized comparison of oral misoprostol and oxytocin for premature rupture of membranes at term.", "The routine use of oxytocin after oral misoprostol for labour induction in women with an unfavourable cervix is not of benefit.", "Safety and efficacy of misoprostol orally and vaginally: a randomized trial.", "Oral misoprostol vs. vaginal misoprostol for cervical ripening and labor induction.", "Oral misoprostol for induction of labor in prelabor rupture of membranes (PROM) at term: a randomized control trial.", "Titrated oral compared with vaginal misoprostol for labor induction: a randomized controlled trial.", "A comparison of orally administered misoprostol to intravenous oxytocin for labor induction in women with favorable cervical examinations.", "Misoprostol for cervical ripening at and near term--a comparative study.", "Oral misoprostol or vaginal dinoprostone for labor induction: a randomized controlled trial." ]

[ "To compare labor induction intervals between oral misoprostol and intravenous oxytocin in women who present at term with premature rupture of membranes.\n One hundred eight women were randomly assigned to misoprostol 50 microg orally every 4 hours as needed or intravenous oxytocin. The primary outcome measure was time from induction to vaginal delivery. Sample size was calculated using a two-tailed alpha of 0.05 and power of 80%.\n Baseline demographic data, including maternal age, gestation, parity, Bishop score, birth weight, and group B streptococcal status, were similar. The mean time +/-standard deviation to vaginal birth with oral misoprostol was 720+/-382 minutes compared with 501+/-389 minutes with oxytocin (P = .007). The durations of the first, second, and third stages of labor were similar. There were no differences in maternal secondary outcomes, including cesarean birth (eight and seven, respectively), infection, maternal satisfaction with labor, epidural use, perineal trauma, manual placental removal, or gastrointestinal side effects. Neonatal outcomes including cord pH, Apgar scores, infection, and admission to neonatal intensive care unit were not different.\n Although labor induction with oral misoprostol was effective, oxytocin resulted in a shorter induction-to-delivery interval. Active labor intervals and other maternal and neonatal outcomes were similar.", "nan", "To evaluate the efficacy of oral and vaginal misoprostol compared with the standard regimen using dinoprostone for induction of labor.\n We conducted a multicenter, randomized controlled trial in Cape Town, South Africa. A total of 573 women admitted for induction of labor were randomized to receive oral misoprostol, vaginal misoprostol, or the control, dinoprostone. Misoprostol was given orally or vaginally as a 50-microg dose at 6-hour intervals to a maximum of four doses. The dinoprostone gel was given as a 1-mg dose in the posterior fornix every 6 hours (maximum two doses).\n There was no significant difference in vaginal delivery rate in 24 hours between the vaginal misoprostol and dinoprostone groups. However, significantly fewer women delivered vaginally in the oral misoprostol group compared with those in the dinoprostone group (relative risk 0.71, 99% confidence interval 0.51, 0.99). The median induction to vaginal delivery time in the vaginal misoprostol, oral misoprostol, and dinoprostone groups was 12 hours, 23 hours, and 14 hours, respectively. The cesarean rate was approximately 33% in all the groups. There were more cesareans performed for fetal distress in the vaginal misoprostol group compared with the dinoprostone group (relative risk 2.86, 99% confidence interval 1.49, 5.46). There was a higher incidence of tachysystole in the vaginal misoprostol group (5.8%) compared with the other two groups: oral misoprostol (0.8%) and dinoprostone (0.8%), but this difference was not statistically significant. There were no differences in maternal or fetal complications.\n Vaginal misoprostol is as effective as dinoprostone in induction of labor, but it is associated with more tachysystole and cesarean sections for fetal distress compared with dinoprostone. Oral misoprostol results in fewer vaginal deliveries in 24 hours, but it is not associated with increased tachysystole or fetal distress.", "The purpose of this study was to compare the efficacy and safety of stepwise oral misoprostol vs vaginal misoprostol for cervical ripening before induction of labor.\n Two hundred and four women between 32 to 42 weeks of gestation with an unfavorable cervix (Bishop score < or = 6) and an indication for labor induction were randomized to receive oral or vaginal misoprostol every 4 hours up to 4 doses. The oral misoprostol group received 50 microg initially followed by 100 microg in each subsequent dose. The vaginal group received 25 microg in each dose. The primary outcome was the interval from first misoprostol dose to delivery. Patient satisfaction and side effects were assessed by surveys completed after delivery.\n Ninety-three (45.6%) women received oral misoprostol; 111 (54.4%) received vaginal misoprostol. There was no difference in the average interval from the first dose of misoprostol to delivery in the oral (21.1 + 7.9 hrs) and vaginal (21.5 + 11.0 hrs, P = NS) misoprostol groups. The incidence of hyperstimulation in the oral group was 2.2% vs 5.4% in the vaginal group, P = NS. Eighteen patients in the oral group (19.4%) and 36 (32.4%) in the vaginal group underwent cesarean section (P < .05). This difference was attributed to better tolerance of more doses of misoprostol by the women in the oral group. There was no difference in side effects (nausea, vomiting, diarrhea, shivering) between groups. Fourteen percent of women in the vaginal group versus 7.5% in the oral group were dissatisfied with the use of misoprostol (P = NS).\n Stepwise oral misoprostol (50 microg followed by 100 microg) appears to be as effective as vaginal misoprostol (25 microg) for cervical ripening with a low incidence of hyperstimulation, no increase in side effects, a high rate of patient satisfaction, and is associated with a lower cesarean section rate.", "The study was undertaken to compare the efficacy, safety, and maternal satisfaction of oral misoprostol and intravenous oxytocin for labor induction in women with premature rupture of membranes at term.\n One hundred five women were stratified by parity and randomly assigned to oral misoprostol 75 microg every 4 hours as needed to establish labor or to intravenous oxytocin.\n The induction to vaginal delivery time with oral misoprostol was 737 (+/-426) minutes compared with 573 (+/-318) minutes with oxytocin (P=.04). The incidence of hyperstimulation was lower in the misoprostol group (6.0% vs 27.1%, P=.005). Women were more likely to be very satisfied with their care in the misoprostol group (86.0% vs 63.4%, P=.02).\n In women at term with premature rupture of membranes, oral misoprostol resulted in a longer induction to vaginal delivery interval but increased maternal satisfaction and less hyperstimulation compared with intravenous oxytocin. Further research is needed to assess uncommon neonatal and maternal outcomes.", "To compare the effectiveness and safety between intravaginal and oral misoprostol for labor induction.\n One hundred and six pregnant women at term with unfavorable cervix (Bishop score < or = 4) and no contraindication to prostaglandin therapy were randomized to receive either intravaginal misoprostol 50 microg every 4 h or oral misoprostol 50 microg every 4 h for prospective randomized controlled trial study. Treatment interval from induction to vaginal delivery, maternal and neonatal complications were the main outcome measures.\n There were no statistical differences of baseline characteristics and Bishop score prior to intervention between both groups. Time interval from induction to vaginal delivery in the oral group was slightly, but significantly, longer than that of the intravaginal group (886.1 +/- 443.5 min vs 637.0 +/- 373.3 min, respectively.) Additionally, the number of doses required was significantly higher in the oral group. Nonetheless, there was no significant difference between both groups with regard to failure of induction and maternal-neonatal complications.\n The effectiveness in terms of failed induction and safety were comparable between intravaginal and oral misoprostol, but intravaginal route was better with respect to treatment interval and number of required doses. Both routes of administration can alternatively be used for labor induction.", "The aim of the study is to compare the efficacy and safety of oral (100 microg) and vaginal (50 microg) misoprostol for labor induction.\n Ninety-nine patients with indications for labor induction randomly received 100 microg oral misoprostol every 4 h or 50 microg vaginal misoprostol every 4 h, using maximum six doses. Mean induction to delivery interval, mode of delivery, rates of tachysystole, hypertonus and hyperstimulation syndrome, oxytocin use, number of doses used, failed induction rate and neonatal outcomes were compared for the two groups.\n Mean dose of misoprostol used for oral and vaginal misoprostol groups were 2.17+/-1.35 and 1.91+/-0.94, respectively (p=0.65). There were two failed inductions in the oral (4%) and one failed induction (2.5%) in the vaginal group after a total of six doses of misoprostol (p=0.58). There was no significant difference for the mean induction to delivery interval, to the beginning of active phase interval, active phase duration, second stage duration and the number of women who received oxytocin for induction or augmentation between the two groups (p>0.05). There were also no significant differences for intrapartum complications and neonatal outcomes between the oral and vaginal misoprostol groups (p>0.05).\n Our findings indicate that, in a closely supervised hospital setting with adequate monitoring, 100 microg oral misoprostol has the potential to induce labor as safely and effectively as its 50 microg vaginal analogue. As oral use of the drug is easier for both the patient and the doctor, oral misoprostol will probably be more preferable than the vaginal route.", "To compare oral misoprostol solution with vaginal prostaglandin gel (dinoprostone) for induction of labour at term to determine whether misoprostol is superior.\n Randomised double blind placebo controlled trial.\n Maternity departments in three hospitals in Australia. Population Pregnant women with a singleton cephalic presentation at > or = 36+6 weeks' gestation, with an indication for prostaglandin induction of labour.\n 20 mug oral misoprostol solution at ourly intervals and placebo vaginal gel or vaginal dinoprostone gel at six hourly intervals and placebo oral solution.\n Vaginal birth within 24 hours; uterine hyperstimulation with associated changes in fetal heart rate; caesarean section (all); and caesarean section for fetal distress.\n 741 women were randomised, 365 to the misoprostol group and 376 to the vaginal dinoprostone group. There were no significant differences between the two treatment groups in the primary outcomes: vaginal birth not achieved in 24 hours (misoprostol 168/365 (46.0%) v dinoprostone 155/376 (41.2%); relative risk 1.12, 95% confidence interval 0.95 to 1.32; P = 0.134), caesarean section (83/365 (22.7%) v 100/376 (26.6%); 0.82, 0.64 to 1.06; P = 0.127), caesarean section for fetal distress (32/365 (8.8%) v 35/376 (9.3%); 0.91, 0.57 to 1.44; P = 0.679), or uterine hyperstimulation with changes in fetal heart rate (3/365 (0.8%) v 6/376 (1.6%); 0.55, 0.14 to 2.21; P = 0.401). Although there were differences in the process of labour induction, there were no significant differences in adverse maternal or neonatal outcomes.\n This trial shows no evidence that oral misoprostol is superior to vaginal dinoprostone for induction of labour. However, it does not lead to poorer health outcomes for women or their infants, and oral treatment is preferred by women.\n National Health and Medical Research Council, Perinatal Trials, PT0361.", "Our purpose was to compare orally administered with vaginally administered misoprostol for cervical ripening and labor induction.\n Two hundred twenty subjects with medical or obstetric indications for labor induction and undilated, uneffaced cervices were randomly assigned to receive orally administered or vaginally administered misoprostol. Fifty micrograms of oral misoprostol or 25 microgram of vaginal misoprostol was given every 4 hours. If cervical ripening (Bishop score of >/=8 or cervical dilatation of >/=3) or active labor did not occur, repeated doses were given to a maximum of 6 doses or 24 hours. Thereafter, oxytocin was administered intravenously by a standardized incremental infusion protocol to a maximum of 22 mU/min.\n Of the 220 subjects evaluated, 110 received orally administered misoprostol and 110 received vaginally administered misoprostol. Fewer subjects who received the oral preparation (34/110, 30.9%) were delivered vaginally within 24 hours of initiation of induction, in comparison with those who received the vaginal preparation (52/110, 47.3%) (P =.01). The average interval from start of induction to vaginal delivery was nearly 6 hours longer in the oral treatment group (mean and SD 1737.9 +/- 845.7 minutes) than in the vaginal treatment group (mean and SD 1393.2 +/- 767.9) (P =.005, log-transformed data). Orally treated patients required significantly more doses than vaginally treated patients (orally administered doses: mean and SD 3.3 +/- 1.7; vaginally administered doses: mean and SD 2.3 +/- 1.2) (P <.0001). Oxytocin administration was necessary in 83 (75.4%) of 110 orally treated subjects and in 65 (59.1%) of 110 vaginally treated subjects (P =.01, relative risk 1. 28, 95% confidence interval 1.06-1.54). Vaginal delivery occurred in 95 (86.4%) orally treated subjects and in 85 (77.3%) vaginally treated subjects (P =.08, relative risk 1.12, 95% confidence interval 0.99-1.27), with the remainder undergoing cesarean delivery. There was no difference in the incidence of uterine contractile abnormalities (tachysystole, hypertonus, or hyperstimulation), intrapartum complications, or neonatal outcomes between the 2 groups.\n Oral administration of 50-microgram doses of misoprostol appears less effective than vaginal administration of 25-microgram doses of misoprostol for cervical ripening and labor induction. Further investigation is needed to determine whether orally administered misoprostol should be used for cervical ripening and labor induction.", "To compare the efficacy and safety of a single dose of 50 microg oral misoprostol with 25 microg vaginal misoprostol for labor induction.\n This study was a randomized, double-blind controlled trial conducting in pregnant women admitted at delivery room, Department of Obstetrics and Gynecology, Bangkok Metropolitan Administration Medical College and Vajira Hospital between March 2002 and January 2005. All 146 pregnancies at > or = 37 weeks' gestation who had indication for labor induction with unfavorable cervix were randomly divided into a group of single dose of 50 microg misoprostol orally or 25 microg misoprostol vaginally. Initial and six hours after misoprostol administration, Bishop scores were evaluated. Requirement of oxytocin augmentation, complication due to uterine hypertonus, incidence of vaginal delivery, Apgar score at 1 and 5 minutes, and number of neonate admitted at neonatal intensive care unit (NICU) were recorded.\n The baseline characteristics and median initial Bishop scores were comparable in both groups. At 6 hours after misoprostol administration the median cervical changes of women who received oral or vaginal misoprostol were statistically significant different, 3 and 4, respectively. The median time interval to vaginal delivery of women who received oral misoprostol was significantly longer than of those who had vaginal drug, 16.9 and 11.8 hours respectively. Comparable neonatal outcomes were found in both groups in terms of assigned Apgar score at 1 and 5 minutes.\n A single dose of 25 microg vaginal misoprostol appears to be more effective than 50 microg oral dose in improving Bishop scores and decreasing the time to vaginal delivery in women with unfavorable cervix without severe adverse effects.", "To compare efficacy, safety, and tolerance of oral misoprostol with intracervical dinoprostone for cervical ripening and labor induction.\n Two hundred women were randomized to receive single doses of oral misoprostol 200 microg or 0.5 mg of dinoprostone intracervically every 6 hours for a maximum four doses.\n The intervals from administration of the drug to active phase of labor (11.1 hours [7-24] versus 15.8 hours [7.5-29.62], P =. 01), to delivery (14.0 hours [8.42-27.61] versus 20.2 hours [16.7-32. 8], P =.01), and to rupture of membranes (10.0 hours [4.95-24.7] versus 15.6 hours [8.2-29.2], P =.003) were significantly shorter in the misoprostol group. All those variables were not distributed normally, so results are presented as median and interquartile range. The rates of women who needed oxytocin (68% versus 52%, P =.03) and cesarean for failed induction (9% versus 1%, P =.01) were higher in the dinoprostone group.\n A single dose of 200 microg oral misoprostol was more effective for cervical ripening and labor induction than 0.5 mg of dinoprostone intracervically every 6 hours, with a maximum of four doses.", "To investigate the effectiveness of oral misoprostol as a cervical priming agent for patients presenting with pre-labor rupture of membranes at term.\n Eighty patients presenting with pre-labor rupture of membranes at term were randomized to receive either 200 micrograms of misoprostol or 50 mg of vitamin B6 orally 1 hour after admission. Labor was induced with intravenous oxytocin infusion 12 hours after oral medication if the patient did not go into labor. We compared the induction rate, duration of labor, mode of delivery, and leaking-to-delivery interval in the two groups.\n The cervical score was significantly improved and the induction rate was also reduced in the misoprostol group when compared with the control group. The interval from recruitment to onset of labor, duration of labor, and the interval from recruitment to delivery were significantly shorter in the misoprostol group. The mode of delivery and the perinatal outcome were similar for the two groups.\n Oral misoprostol is an effective agent for cervical priming and labor induction in patients with pre-labor rupture of membranes at term.", "To compare the efficacy of vaginal misoprostol (25 microg) to oral misoprostol (100 microg) in labor induction at term.\n One hundred and one women at term, with indications for labor induction and cervical Bishop's scores of less than 8, were randomly assigned to receive 100 microg of oral misoprostol or 25 microg vaginal misoprostol after random allocation. This could be repeated every 4 h to a maximum of five doses. The number delivering vaginally within 24 h of the induction was the main outcome measure.\n Of those who delivered vaginally (74.5% in the oral group vs. 72% in the vaginal group), significantly fewer women delivered within 24 h of induction in the oral group (42.1% vs. 72.2%, RR 0.6, 95% CI 0.4-0.9), with more women receiving more than one dose (45.7% vs. 16.7%, RR 2.7, 95% CI 1.2-6.0). More women in the oral group received oxytocin (68.6% vs. 44%, RR 1.6, 95% CI 1.1-2.2), and the induction to delivery interval was shorter in the vaginal group, although this was not statistically significant [28.9 h (SD 20.2) vs. 20.6 h (SD 16.1), mean difference - 8.3 h, 95% CI - 16.8 to 0.2]. There were no differences in the modes of delivery, uterine hyperstimulation rates or in the neonatal outcomes.\n Vaginal misoprostol in its currently recommended dose of 25 microg seems to be more efficacious than the 100 microg oral dose.", "251 women with indications for labor induction at term were randomised to receive either 50 or 100 microgs of oral misoprostol, repeated every 4 h to a maximum of 5 doses. Parous women in the higher dose group received 50 microgs as their first dose, subsequent doses being 100 microgs. Women who failed to respond to the 5 doses of misoprostol had the option of having vaginal PGE2 gel. The primary outcome measure was the induction to delivery interval in those who delivered vaginally. Patient satisfaction was assessed by postnatal questionnaire.\n The induction to vaginal delivery interval, although shorter in the 100 microgs group was not statistically significant (26.8 versus 33.7 h, mean difference 6.9 h, 95% CI 0.4-13). There were, however, more failed inductions with misoprostol in the 50 microgs group (12.7% Vs 4.8%, RR 2.6, 95% CI 1.07-6.5). There were no differences in the modes of delivery, number of caesarean sections for fetal distress or in the neonatal outcomes in the two groups. Most patients, 83% and 92% in the 50 and 100 microgs, respectively, were satisfied with their inductions, and 64% of patients would prefer to have the inducing agent given orally if they were to have another induction.\n Oral misoprostol is effective in inducing labor and seems acceptable to patients. Both the 50 and 100 microgs dose regimens have a reasonable safety profile, but in view of the higher incidence of failed inductions with the 50 microgs dosage, the 100 microgs dose regimen may be the preferred dose regimen.", "To compare the efficacy of 100 microg of oral misoprostol with 3 mg prostaglandin E2 vaginal tablets in term labour induction.\n A non-blinded, randomised, controlled trial.\n A tertiary level, teaching Scottish Hospital.\n Two hundred women at term with indications for labour induction and modified Bishop's cervical score of less than 8.\n The women were randomly allocated to receive either 100 microg of misoprostol orally (which could be repeated 4 hourly to a maximum of five doses if indicated), or a 3 mg tablet of prostaglandin E2 vaginally (which could be repeated in 6 hours, according to routine departmental protocol).\n The number delivering vaginally within 24 hours of the induction.\n Seventy-five women delivered vaginally in the misoprostol group and 73 in the PGE2 group. Of these, 50.7% in the misoprostol group and 54.8% in the PGE2 group delivered within 24 hours of the induction (RR 0.92, 95% CI 0.7 to 1.3). More women in the misoprostol group were given oxytocin, but this was not statistically significant (60%vs 47%, RR 1.3, 95% CI 0.98 to 1.7). Two women in the misoprostol group had uterine hyperstimulation. The neonatal outcomes were not significantly different in the two groups. There was a pound 1100 saving on direct drug costs in the misoprostol group.\n Oral misoprostol (100 microg) has similar efficacy to vaginal PGE2 tablets, and may be an option to consider for term labour induction.", "The purpose of this study was to compare the efficacy of different routes of misoprostol administration for cervical ripening and the induction of labor.\n Three hundred thirty women at > or = 32 weeks gestation with a Bishop score < or = 6 and an indication for induction were randomized to 1 of 3 double-blinded groups: (1) 25 microg orally administered misoprostol plus 25 microg vaginally administered misoprostol, (2) orally administered placebo plus 25 microg vaginally administered misoprostol, or (3) 25 microg orally administered misoprostol plus vaginally administered placebo. Doses were repeated every 4 hours until onset of labor or a maximum of 12 doses were given. The primary outcome of the trial was vaginal delivery within 24 hours of the initiation of induction. Secondary outcomes were the time from induction to delivery, need for oxytocin augmentation, mode of delivery, frequency of side effects, and neonatal and maternal outcome. Analysis of variance, chi-square test, and logistic regression were used for analysis.\n There were no significant differences in maternal characteristics or indications for induction. The percentage of women who achieved vaginal delivery within 24 hours was highest in the vaginally administered misoprostol group: 67% compared with 53% in the oral-plus-vaginal group (P < .05) and 36% in the oral group (P < .05). The median time to vaginal delivery was shorter in the vaginal and oral-plus-vaginal misoprostol groups, 13.5 hours and 14.3 hours, respectively, when compared with 23.9 hours in the oral group (P < .05). The rate of cesarean delivery was lowest in the vaginal misoprostol group (17% compared with 30% in the oral-plus-vaginal group and 32% in the oral group; P < .05). Uterine tachysystole occurred least frequently in the oral misoprostol group (10% compared with 32% in the vaginal group and 34% in the oral-plus-vaginal group; P < .05). Uterine hyperstimulation also occurred least frequently in the oral misopro-stol group (4% compared with 15% in the vaginal group and 22% in the oral-plus-vaginal group; P < .05).\n At the doses studied, induction of labor with vaginally administered misoprostol is more efficacious than either oral-plus-vaginal or oral-only route of administration.", "To compare orally administered misoprostol with intravaginal prostaglandin E2 for cervical ripening and labor induction.\n Patients presenting with medical or obstetric indications for labor induction whose Bishop's score was < or = 6 were randomly allocated to receive either 50 micrograms of oral misoprostol or 4 mg of intravaginal prostaglandin E2. If adequate cervical ripening (Bishop score of 9 or cervical dilatation of 3) or active labor did not ensue, repeat doses of each medication were administered every four hours. A maximum of six doses of either oral misoprostol or intravaginal prostaglandin E2 was permitted. Intravenous oxytocin was subsequently administered according to a standardized infusion protocol.\n Sixty patients were enrolled, with 29 randomized to the oral misoprostol arm and 31 to the prostaglandin E2 group. The data on 58 patients were eligible for analysis. Delivery occurred within 48 hours in 96.4% (27/28) of those administered oral misoprostol as compared to 76.7% (23/30) of those who received intravaginal prostaglandin E2 (P = .03). The mean time intervals from the start of induction to delivery were similar between the two groups (1,496 +/- 120 vs. 1,723 +/- 230 minutes, P = .40). No statistically significant differences existed between the two groups with respect to intrapartum complications, tachysystole, uterine hyperstimulation or adverse neonatal outcomes.\n Oral administration of misoprostol is an effective alternative to intravaginal prostaglandin E2 for preinduction cervical ripening.", "To compare the labour pattern and uterine activity of oral misoprostol with oxytocin for labour induction in women presenting with prelabour rupture of membranes at term.\n Prospective randomised study.\n Department of Obstetrics and Gynaecology, Queen Mary Hospital, Hong Kong.\n Eighty women presenting with prelabour rupture of membranes at term.\n The women were randomised to receive either 100 microg misoprostol orally every 4 hours to a maximum of three doses, or intravenous oxytocin infusion according to the hospital protocol. Intrauterine pressure transducers were inserted one hour before induction of labour in both groups of women. We compared the pattern of uterine activity, the induction-to-delivery interval, duration of labour, mode of delivery and neonatal outcome between the two groups.\n Both oxytocin and oral misoprostol caused an increase in uterine activity within one hour of labour induction. Peak uterine activity was reached 6-8 h after oral misoprostol, with persistent effects, and 8-10 h after oxytocin, requiring continuous titration of medication. The duration of labour was significantly reduced in nulliparous women, but not in those who were multiparous in the misoprostol group. The induction-to-delivery interval, the mode of delivery and the perinatal outcome were similar for the two groups.\n Oral misoprostol caused earlier peak uterine activity, compared with oxytocin (6-8 h vs 8-10 h). Oral misoprostol was not only as effective as oxytocin in inducing labour in women at term with prelabour rupture of the membranes, but it reduced significantly the duration of labour in nulliparous women.", "To compare labour outcome in women who had labour induced with PGF2 alpha gel, PGE2 vaginal pessary or misoprostol administered intravaginally or orally.\n Unmasked randomised controlled trial.\n Department of Obstetrics and Gynaecology, University of Zimbabwe, Harare.\n Women with a singleton foetus in cephalic presentation after 37 weeks gestation admitted for induction of labour who were randomised to prostaglandin F2 alpha gel (n = 76), prostaglandin E2 pessary (n = 75) and misoprostol administered either intra-vaginally (n = 128) or orally (n = 127).\n Primary outcome was induction to delivery interval. Secondary outcomes included use of oxytocin during labour, mode of delivery, duration of labour, neonatal condition at delivery and maternal complications.\n Four hundred and six women admitted for induction of labour with a singleton foetus in cephalic presentation after 37 weeks gestation were enrolled. To estimate the risk with induction using other agents the odds ratio and 95% confidence interval was calculated using the group that received prostaglandin F2 alpha gel as referents.\n The women were comparable for baseline characteristics. Compared to prostaglandin F2 alpha gel, the need for augmentation with oxytocin in labour was significantly reduced in women induced with prostaglandin E2 pessary (OR 0.46; 95%CI 0.23 to 0.93), vaginal misoprostol (OR 0.34; 95%CI 0.18 to 0.63) and oral misoprostol (OR 0.42; 95%CI 0.22 to 0.78). There was no difference in mode of delivery. There was a significantly reduced risk (OR 0.20; 95%CI 0.04 to 0.86) of Caesarean section (CS) for failure to progress in the vaginal misoprostol group. Labour induced with misoprostol and prostaglandin E2 pessary was significantly shorter than in prostaglandin F2 alpha gel. Vaginal misoprostol significantly shortened the induction to delivery interval. There were more admissions to the neonatal unit in the misoprostol groups.\n Compared to prostaglandin F2 alpha gel, misoprostol and prostaglandin E2 pessary had reduced need for oxytocin and a shorter duration of labour. Effects of misoprostol on the foetus need further investigation before it is used as a routine agent for induction of labour.", "To determine if oral misoprostol can replace oxytocin for labor stimulation in women with ruptured membranes at term and without evidence of labor.\n Nulliparous women at 36 to 41 weeks with a singleton, cephalic-presenting fetus and ruptured membranes without evidence of labor were randomized to receive oral misoprostol (100 microg) or a placebo every 4 hours for a maximum of two doses. Intravenous oxytocin was initiated if active labor had not ensued within 8 hours of the initial study drug dose.\n Fifty-one women were randomized to oral misoprostol and 51 women to the placebo. Misoprostol reduced the use of oxytocin stimulation of labor from 90% to 37% (P <.001) and was associated with approximately a 7-hour shorter elapsed time in the labor unit. Uterine hyperactivity, defined as six or more contractions in 10 minutes without fetal heart rate decelerations, occurred in 25% of women randomized to misoprostol. However, uterine hyperactivity associated with fetal heart rate decelerations occurred in only three (6%) women, none of whom required emergency cesarean delivery. Route of delivery and infant outcomes were not related to misoprostol use.\n Oral misoprostol (100 microg) given in a maximum of two doses 4 hours apart significantly reduced the use of oxytocin in the management of women with ruptured membranes without labor at term.", "To compare the efficacy of oral with vaginal misoprostol for induction of labor at term.\n One hundred and fifty-three pregnant women at term with indications for induction of labor and Bishop score < or = 6 were randomly assigned to receive misoprostol either 100 microg orally or 50 microg vaginally every 6 h for 48 h. Repeated doses were given until Bishop score > or = 8 was achieved or spontaneous rupture of membranes occurred. Those who were not in labor after 48 h had labor induced with amniotomy and oxytocin. The main outcome measure was induction to delivery time.\n The median induction to vaginal delivery time in the oral group (14.3 h) was not significantly different from that of the vaginal group (15.8 h). The median number of doses was also not significantly different in the oral group compared with the vaginal group. There was a significant higher incidence of uterine tachysystole in the vaginal group compared to the oral group (17.1% vs 5.3%, P = 0.032). There was no hyperstimulation in either group. There were no significant differences between the groups with respect to oxytocin augmentation, cesarean section rate, analgesic requirement, and neonatal outcomes.\n Oral administration of 100 microg misoprostol has similar efficacy to intravaginal administration of 50 microg misoprostol for labor induction with less frequent abnormal uterine contractility. 100 microg of misoprostol orally can be used as an alternative to the vaginal route for labor induction.", "To determine the efficacy of 200 microg single dose oral misoprostol as a cervical priming agent at term.\n In this double-blind randomized trial, 156 pregnant women requiring induction of labor with gestational age of 37-42 weeks and Bishop score < or =5, were randomized to receive either 200 microg of misoprostol or a placebo, orally. Labor was induced with intravenous oxytocin infusion 12 h after oral medication if the patient did not go into labor. The primary outcome was the change in the Bishop score 12 h after oral medication. The secondary outcomes were the timings starting from the drug administration to the onset of uterine activity, interval between oral medication and delivery, oxytocin need for induction, mode of delivery, frequency of side effects, and neonatal and maternal outcome. The chi-square or Fisher exact test, Student's t-test, and Mann-Whitney U-test were used for analysis of the data.\n There were no significant differences in maternal characteristics or indications of induction. The Bishop score 12 h after oral medication significantly improved in the misoprostol group compared with the control group [55 (70%)>8 vs. 4 (5%)>8; P<0.001]. The induction rate was significantly reduced in the misoprostol group (P<0.001). The interval between oral medication and the onset of uterine activity was significantly shorter in the misoprostol group (P<0.001). The interval between oral medication and delivery was also significantly shorter in the misoprostol group (P<0.001). The cesarean delivery rate was significantly lower in the misoprostol group (P<0.001). There were no differences between the groups with respect to the incidence of tachysystole, hyperstimulation, adverse neonatal or maternal outcome.\n Oral administration of 200 microg single dose of misoprostol is an effective agent not only for cervical priming but also for induction of labor at term. Furthermore, it reduces the rate of cesarean deliveries.", "To compare the active management of term prelabour rupture of membranes with oral misoprostol with conservative management for 24 hours followed by induction with oxytocin or prostaglandin E(2) (PGE(2)) gel.\n A non-blinded randomised controlled trial.\n Induction and labour wards, Aberdeen Maternity Hospital.\n Sixty-one women with confirmed prelabour rupture of the membranes at > or =36 weeks of gestation.\n The women were randomised to 50 microg of oral misoprostol repeated every 4 hours, if required, to a maximum of five doses (active group), or to induction of labour with PGE(2) gel or oxytocin only if not in spontaneous labour 24 hours after prelabour rupture of membranes (conservative group).\n Number of women in active labour within 24 hours of the prelabour rupture of membranes, preference of women for any one particular method of management in any subsequent pregnancy with prelabour rupture of membranes.\n 93.3% of the active group and 54.8% of the conservative group were in spontaneous labour within 24 hours of the prelabour rupture of membranes (RR 1.7, 95% CI 1.2 to 2.4). Of those achieving a vaginal delivery, 72% of the active group did so within 24 hours of the prelabour rupture of membranes as compared with 26.9% of the conservative group (RR 2.7, 95% CI 1.4 to 5.3, P = 0.002). There were no significant differences in the neonatal or maternal outcomes. In the active group, 78% felt they would have the same method of induction as compared with 40% in the conservative group (RR 1.9, 95% CI 1.1 to 3.3, P = 0.03).\n Active management with oral misoprostol resulted in more women going into labour and delivering within 24 hours of the prelabour rupture of membranes with no increase in maternal or neonatal complications. Women tended to view active management of prelabour rupture of membranes more positively. Oral misoprostol might be an option to consider in those wishing active management.", "To evaluate the efficacy and safety of oral misoprostol for labor induction in women with term premature rupture of membranes (PROM) and an unfavorable cervix.\n We randomized 130 women with PROM of < or =4 h to either oral misoprostol, 50 microg, or a placebo given every 4 h for up to three doses. Intravenous oxytocin was initiated if active labor did not begin within 12 h.\n Sixty-four women received oral misoprostol and 66 received placebo. The PROM-to-delivery interval was shorter with misoprostol than with placebo (13.7+/-5.8 vs. 20.3+/-6.8 h, respectively, P<0.05). Misoprostol significantly reduced the need for oxytocin (28.1 vs. 72.7%, P<0.001) and antibiotics (25 vs. 69.7%, P<0.001). No significant differences in cesarean section or hyperstimulation rate were noted.\n Oral misoprostol given to women with unfavorable cervix soon after term PROM significantly reduces the induction-to-delivery time and the need for oxytocin and antibiotics.", "To compare oral misoprostol with dinoprostone for induction of labor and their effects on the fetal heart rate patterns.\n In a randomized controlled trial, 200 patients received either misoprostol 50 mug orally for every 4 h, or dinoprostone 0.5 mg intracervically for every 6 h. Cardiotocographic recordings, in 10-min windows 30, 60, and 80 min after prostaglandin administration during induction and continuously during labor, were compared between the two groups. Primary outcome for effectiveness and safety was assessed in terms of the number of vaginal deliveries within 24 h and fetal heart rate abnormalities during induction and labor respectively.\n Data from 96 patients in the misoprostol group and 95 in the dinoprostone group were analyzed. There were no significant differences in respect of the number of vaginal deliveries within 24 h (RR 1.12; 95% CI 0.88-1.42). The frequency of suspicious and pathological fetal heart rate patterns did not differ significantly but significantly more cardiotocographs in the dinoprostone group had non-reassuring baseline variability 60 min after dose administration (RR 0.33; 95% CI 0.14-0.77). Maternal and neonatal outcomes did not differ significantly.\n Oral misoprostol is as effective as intracervical dinoprostone for induction of labor with no difference in the frequency of fetal heart rate abnormalities.", "To compare three methods of labour induction.\n Randomised controlled trial.\n Academic hospitals in Johannesburg, South Africa.\n Women with intact membranes due for induction of labour.\n Randomised, sealed opaque envelopes were used to allocate women to labour induction with extra-amniotic Foley catheter/titrated oral misoprostol solution (N = 174), titrated oral misoprostol solution alone (N = 176), or vaginal dinoprostone (N = 176). Misoprostol was dissolved in water and 20-40 g was given 2-hourly.\n These were failure to deliver vaginally within 24 hours, additional measures for induction or augmentation of labour, analgesia, and maternal and fetal complications.\n In the Foley catheter group, misoprostol was required in all but 1 case. Failure to deliver vaginally within 24 hours was similar for the three groups (79/174 v. 70/176 v. 70/176 respectively). Labour augmentation, caesarean section and instrumental delivery were used somewhat more frequently in the Foley/misoprostol group than in the misoprostol alone group, but these differences were not statistically significant. More analgesia was used in the Foley catheter/misoprostol group than in the misoprostol group (64/172 v. 46/175). Side-effects and neonatal complications were similar for the three groups.\n Use of extra-amniotic Foley catheter placement showed no measurable benefits over the use of oral misoprostol alone, or vaginal dinoprostone.", "To compare the efficacy of oral with vaginal misoprostol for induction of labour at term.\n Randomised trial.\n Tertiary Care hospital.\n One hundred and sixty-seven women requiring induction of labour.\n The women were randomised to receive 50 microg of misoprostol orally or vaginally every 6 h until the cervix was favourable for amniotomy, spontaneous rupture of membranes, or active labour occurred. Sample size was calculated with a two-tailed alpha of 0.05 and a power of 95% to detect a 5 h difference in induction-to-delivery time. Student's t test was used for comparison of normally distributed continuous variables and the Mann-Whitney U test was used for non-Gaussian distributed continuous variables. Fisher' s exact and chi2 tests were used for comparison of categorical variables. The main outcome measure was induction to delivery time.\n The median induction to delivery time was significantly shorter with vaginal misoprostol (15.7 h range 4.3-55.7), compared with oral misoprostol (23.0 h range 3.2-141.7, P = 0.0013). The median number of doses was also significantly less in the vaginal misoprostol group, 1 (range 1-3), compared with the oral group, 2 (range 1-8), (P < 0.0001). The significant differences in outcome held true when nulliparous and multiparous women were analysed separately. There were no differences between the two routes of administration with respect to rates of hyperstimulation or neonatal asphyxia. There were more caesarean sections in the vaginal misoprostol group, but the difference was not statistically significant.\n Compared with oral misoprostol, vaginal misoprostol for induction of labour at term results in a shorter induction-to-delivery time, with fewer doses required per patient. Vaginal misoprostol may be associated with higher rates of caesarean section than oral misoprostol.", "To compare the effectiveness and safety between 50 mcg oral misoprostol every 4 hours and 6 hours for labor induction.\n A prospective randomized controlled trial.\n Department of Obstetrics & Gynecology, Faculty of Medicine, Chiang Mai University, Chiang Mai, Thailand.\n Eighty nine pregnant women of at least 34 weeks' gestation with indications for labor induction in the condition of unfavourable cervix (Bishop score < or = 4) and no contraindication to prostaglandin therapy.\n All pregnant women were randomized to receive either 50 mcg misoprostol orally every 4 hours or 6 hours.\n Treatment interval from induction to vaginal delivery, maternal and neonatal complication.\n The mean treatment intervals from induction to vaginal delivery were 22.10 +/- 18.49 hours and 20.91 +/- 11.98 hours in the misoprostol group every 4 hours and 6 hours, respectively. The treatment intervals between the two groups were not statistically significant. There was also no significant difference between both groups with regard to maternal and neonatal complications.\n The effectiveness in terms of treatment interval from induction to vaginal delivery were comparable between the two groups, but administration of misoprostol every 6 hours was found to have a slightly shorter interval, although it did not reach statistical significance. No serious maternal and neonatal complication was demonstrated in both groups. Either regimen in this study can be an alternative for labor induction.", "To compare the efficacy and safety of 100 microg oral misoprostol for induction of labor between the regimen of 3 hour and 6 hour interval administration.\n Singleton pregnancies indicated for induction of labor between 34 and 42 weeks of gestation in the condition of unfavorable cervix (Bishop score < or = 4) and no contraindication for prostaglandins therapy were recruited into the study. All pregnant women were randomly assigned to receive 100 microg oral misoprostol every 3 hours or 6 hours until the cervix was favorable for amniotomy, spontaneous rupture of membranes or active labor occurred.\n The mean time interval from induction to vaginal delivery was significantly shorter in the 3 hour interval group, compared with the 6 hour interval group (13.82 +/- 6.98h and 17.66 +/- 7.48h, P = 0.0019). There was no significant difference between the groups with regard to mode of delivery, analgesic requirement, maternal complication and neonatal outcome.\n 100 microg oral misoprostol every 3 hours is more effective for labor induction than every 6 hours but there was no difference in mode of delivery, analgesic requirement, maternal complications and neonatal outcome. A dose of 100 microg misoprostol orally every 3 hours seems to be the optimum regimen and the new option for labor induction. However, further study should be performed.", "nan", "This study was undertaken to determine whether induction of labor with oral misoprostol will result in fewer cesarean deliveries than intravenous oxytocin in nulliparous women with premature rupture of membranes at term.\n Three hundred five women at 10 centers were randomly assigned to receive oral misoprostol, 100 microg every 6 hours to a maximum of two doses or intravenous oxytocin. The primary outcome measure was cesarean deliveries. Secondary outcomes were time from induction to vaginal delivery and measures of maternal and neonatal safety.\n The study was stopped prematurely because of recruitment difficulties. We present the results for the 305 enrolled women. There was no difference in the proportion of women who underwent cesarean delivery (20.1% in the misoprostol group, 19.9% in the oxytocin group). The time interval from induction to vaginal delivery was also similar (11.9 hours for the misoprostol group, and 11.8 hours for the oxytocin group). Maternal and neonatal safety outcomes were similar for the two treatments. More infants born to women in the misoprostol group received intravenous antibiotics in the neonatal period (16.4% vs 6.9%, P=.01), although there were no differences in chorioamnionitis or in proven neonatal infections. Women receiving misoprostol were less likely to have postpartum hemorrhage than those receiving oxytocin (1.9% vs 6.2%, P=.05).\n Oral misoprostol does not offer any advantage in time from induction to vaginal delivery or risk of cesarean section.", "Induction of labour with misoprostol is often augmented with oxytocin with the possible consequence of uterine hypercontractility. It is important to determine whether the use of oxytocin in this circumstance has benefit as well as risk.\n To compare two regimens for labour induction in women with an unfavourable cervix: oral misoprostol vs. oral misoprostol routinely followed by oxytocin.\n A prospective randomised trial in which 200 women with an unfavourable cervix received either oral misoprostol 25 microg every 3 h (group 1, n = 100) or two such doses routinely followed by oxytocin (group 2, n = 100). Outcomes included change in Bishop score, induction delivery interval, oxytocin requirement, contraction abnormalities, mode of delivery and neonatal outcome.\n The improvement in Bishop score with two misoprostol doses in all 200 women was highly significant (2.9 +/- 1.5 to 6.6 +/- 1.9, P < 0.0001). The induction delivery interval, Caesarean delivery rate, vaginal delivery rate within 24 h, contraction abnormalities and neonatal outcome were similar in both groups. Contraction abnormalities were remarkably low with either regimen (1%). Routine addition of oxytocin 3 h after the second misoprostol dose (group 2) resulted in the maximum oxytocin dose (64 mU/min) being given to more women (66% in group 2; 36% in group 1).\n There was no benefit of routine addition of oxytocin after two doses of misoprostol. Reduced oxytocin requirement was observed when it was added only if needed. Both regimens achieved 85-87% vaginal deliveries with low incidence of hypercontractility.", "To compare the safety and efficacy accompanying oral and vaginal misoprostol for cervical ripening.\n One thousand four women with medical or obstetric indications for labor induction and unripe cervices were randomly assigned to receive oral or vaginal misoprostol. Initial doses of 200 microg oral and 50 microg vaginal misoprostol were increased to 300 microg oral and 100 microg vaginal after two doses, to a maximum of six doses. Misoprostol was given every 6 hours in both groups. We anticipated that 11% of women treated vaginally would require intervention during the ripening process. Intervention was defined as interruption of the ripening process before labor or Bishop score of 7 or a lack of response to six misoprostol doses.\n Five hundred three subjects were assigned to oral and 501 to vaginal administration. Oral misoprostol was associated with significantly higher frequencies of intervention (67 [13.3%] versus 42 [8.4%], P =.01), tachysystole (114 [23.6%] versus 85 [17.6%], P =.02), and hyperstimulation (90 [18.6%] versus 66 [13.7%], P =.04). There were no significant differences in cesarean rates (147 [29.2%] versus 120 [24.0%], P =.06), mean number of misoprostol doses used (1.5 versus 1.6, P =.18), or hours from drug administration to delivery (24.5 versus 25.4, P =.77) between the oral and vaginal groups, respectively. The numbers of deliveries between the groups within 24 hours was different (271 [56%] versus 290 [60%], P =.02), oral and vaginal, respectively. No adverse neonatal outcomes were noted.\n Oral misoprostol has similar efficacy as vaginal misoprostol but is associated with a higher frequency of excessive uterine contractility and intervention.", "nan", "To compare the efficacy of two different dosages of oral misoprostol (50 and 100 microg) with control, in medical induction of labor for patients with prelabor rupture of membranes (PROM) at term.\n One hundred women with PROM at term were randomized to receive placebo (vitamin B6 50 mg, control), 50 microg (treatment group 1), or 100 microg (treatment group 2) of oral misoprostol every 4 h to a maximum of six doses. The main outcome measures included time interval from onset of PROM to delivery, duration of first stage of labor, and occurrence of vaginal delivery within 24 h from PROM.\n The time intervals from PROM to delivery were significantly reduced in both treatment groups compared to control (control, 25.1+/-10.5 h; treatment group 1, 14.5+/-6.2 h; and treatment group 2, 13.0+/-6.1 h, p<0.0001 for both). The duration of the first stage of labor was significantly shortened only in treatment group 2 compared to control (3.3+/-2.5 versus 6.2+/-3.4 h, p=0.01). Of those who delivered vaginally (93% in treatment group 1 and 97% in treatment group 2), significantly more women delivered within 24 h of PROM in the treatment group compared to the control group (50%, p<0.05).\n Oral misoprostol 50 microg every 4 h is safe, cheap, and as effective as 100 microg in reducing the PROM to delivery time interval and labor duration in primiparous women. The same effect is not observed in a multiparous group.", "To compare the efficacy and safety of titrated oral misoprostol and vaginal misoprostol for labor induction.\n Women between 34 and 42 weeks of gestation with an unfavorable cervix (Bishop score less than or equal to 6) and an indication for labor induction were randomLy assigned to receive titrated oral or vaginal misoprostol. The titrated oral misoprostol group received a basal unit of 20 mL misoprostol solution (1 mcg/mL) every 1 hour for four doses and then were titrated against individual uterine response. The vaginal group received 25 mcg every 4 hours until attaining a more favorable cervix. Vaginal delivery within 12 hours was the primary outcome. The data were analyzed by intention-to-treat.\n Titrated oral misoprostol was given to 101 (48.8%) women and vaginal misoprostol to 106 (51.2%) women. Completed vaginal delivery occurred within 12 hours in 75 (74.3%) women in the titrated oral group and 27 (25.5%) women in the vaginal group (relative risk [RR] 8.44, 95% confidence interval [CI] 4.52-15.76). The incidence of hyperstimulation was 0.0% in the titrated oral group compared with 11.3% in the vaginal group (RR 0.08, 95% CI 0.01-0.61). Although more women experienced nausea (10.9%) in the titrated oral group (RR 27.07, 95% CI 1.57-465.70), fewer infants had Apgar scores of less than 7 at 1 minute in the titrated oral group than in the vaginal group (RR 0.10, 95% CI 0.01-0.76).\n Titrated oral misoprostol is associated with a lower incidence of uterine hyperstimulation and a lower cesarean delivery rate than vaginal misoprostol for labor induction in patients with unfavorable cervix.\n ClinicalTrials.gov, www.clinicaltrials.gov, NCT00529295\n I.", "The purpose of this study was to compare orally administered misoprostol with intravenous oxytocin infusion for labor induction in women with favorable cervical examinations (defined as a Bishop score of 6 or more).\n One hundred ninety-eight women with indications for labor induction and favorable cervical examinations were assigned randomly to receive oral misoprostol or oxytocin induction. Misoprostol, 100 mg, was administered every 4 hours up to 6 doses, or intravenous oxytocin was administered by standardized protocol.\n One hundred ten (55.6%) women received misoprostol; 88 (44.4%) received intravenous oxytocin. There was no statistically significant difference in the average interval from start of induction to vaginal delivery, being longer in the misoprostol group (789.4 +/- 510.2 minutes) than in the oxytocin group (654.0 +/- 338.2 minutes, P=.19, log-transformed data). Two women had tachysystole develop in each treatment group. More women in the misoprostol group experienced hyperstimulation (7/110, 6.4%) than in the oxytocin group (0/88, P=.02, Fisher exact test). Nine (8.1%) misoprostol-treated women and 8 (9.1%) oxytocin-treated women underwent cesarean deliveries (P=.82). There was a presumed uterine rupture in a misoprostol-treated multipara women. There were no statistically significant differences in neonatal outcomes between the groups.\n Oral misoprostol offers no benefit over intravenous oxytocin for labor induction in women with favorable cervical examinations. It is associated with a higher likelihood of uterine hyperstimulation and may increase the risk of uterine rupture.", "To compare the safety and efficacy of misoprostol with that of dinoprostone for the induction of labour at term, or near term.\n Three hundred and ninety-six women with term pregnancies were randomised to receive either oral or vaginal misoprostol, or dinoprostone. Women who had had a previous caesarean section (CS) or those with a malpresentation or who were parity > or = 5, were excluded. The control group received dinoprostone 1 mg inserted in the posterior fornix and repeated 6-hourly to a maximum of three doses. The study group received either oral misoprostol 20 micrograms 2-hourly to a maximum of four doses (80 micrograms), or vaginal misoprostol 25 micrograms in the posterior fornix with a switch to the oral misoprostol regimen if there was no change in the Bishop's score or no palpable uterine contractions.\n There was no significant difference in vaginal delivery rate within 24 hours between the groups (58.1% v. 58%, p = 0.633). There were no significant differences in CS rates between the groups; however, more CSs were performed for fetal distress in the misoprostol group than in the dinoprostone group (28% v. 25%). There was a significantly higher incidence of hyperstimulation in the vaginal misoprostol group (21.4%) than in the other two groups (oral misoprostol 16.5%, dinoprostone 8.9%) (p = 0.004). The incidence of meconium staining of liquor was comparable between the groups.\n In selected women, the efficacy of misoprostol for the induction of labour at term is similar to that of dinoprostone but misoprostol is associated with a higher incidence of hyperstimulation.", "The objective of the study was to compare the effectiveness, safety, and side effects of low-dose oral misoprostol with vaginal dinoprostone for cervical ripening and labor induction.\n Women with Bishop score 6 or less admitted for labor induction at term were eligible for this randomized controlled trial. Exclusion criteria were multiple pregnancy, breech, fetal distress, or previous uterine scar. The allocation to the oral misoprostol group (20 microg given every 2 hours increased to 40 microg depending on uterine contractions) or to the vaginal dinoprostone group (2 mg twice, 6 hours apart) was contained in a sealed, opaque, and consecutively numbered envelope.\n Two hundred women (100 in each group) were included. The proportion of vaginal delivery within 24 hours was 56% in the misoprostol group and 62% in the dinoprostone group (relative risk 0.90, 95% CI 0.72-1.14). The risk of cesarean section was 18% and 19%, respectively. The median interval to delivery, calculated from survival analysis, was longer in the misoprostol group (1305 minutes) compared with the dinoprostone group (1080 minutes). The log-rank test was not significant (P =.35). Uterine hyperstimulation occurred in 9% of women in the misoprostol group compared with 14% in the dinoprostone group (P =.27). The only significant difference in neonatal outcomes was a more frequent presence of thick meconium in the misoprostol group (P =.03).\n We found no difference in terms of effectiveness and safety between low-dose oral misoprostol and vaginal dinoprostone used for induction of labor. This regimen avoids the excessive uterine contractility noted in previous studies, where higher doses of misoprostol were administered at longer intervals." ]

[ "12915593", "9166835", "10381495", "1381626", "10172484", "7532056", "9168439", "7515644", "9402845", "17363838", "9610900", "7528447", "16508640", "7691256", "10640980" ]

[ "CHOP compared with CHOP plus granulocyte colony-stimulating factor in elderly patients with aggressive non-Hodgkin's lymphoma.", "Randomized trial with or without granulocyte colony-stimulating factor as adjunct to induction VNCOP-B treatment of elderly high-grade non-Hodgkin's lymphoma.", "Elderly aggressive-histology non-Hodgkin's lymphoma: first-line VNCOP-B regimen experience on 350 patients.", "Granulocyte colony-stimulating factor to prevent dose-limiting neutropenia in non-Hodgkin's lymphoma: a randomized controlled trial.", "Economic analysis of lenograstim in the correction of neutropenia following chemotherapy for non-Hodgkin's lymphoma.", "Effect of granulocyte colony-stimulating factor in patients with diffuse large cell lymphoma treated with intensive chemotherapy.", "Placebo-controlled phase III study of lenograstim (glycosylated recombinant human granulocyte colony-stimulating factor) in aggressive non-Hodgkin's lymphoma: factors influencing chemotherapy administration. Groupe d'Etude des Lymphomes de l'Adulte.", "Cytokine efficiency in the treatment of high-grade malignant non-Hodgkin's lymphomas: results of a randomized double-blind placebo-controlled study with intensified COP-BLAM +/- rhGM-CSF.", "Randomized open label phase III trial of CEOP/IMVP-Dexa alternating chemotherapy and filgrastim versus CEOP/IMVP-Dexa alternating chemotherapy for aggressive non-Hodgkin's lymphoma (NHL). A multicenter trial by the Austrian Working Group for Medical Tumor Therapy.", "Central nervous system occurrence in elderly patients with aggressive lymphoma and a long-term follow-up.", "Randomized multicentre trial of filgrastim as an adjunct to combination chemotherapy for Hodgkin's disease. West of Scotland Lymphoma Group.", "Recombinant human granulocyte-macrophage colony-stimulating factor as adjunct to chemotherapy in aggressive non-Hodgkin's lymphomas.", "A phase III trial comparing CHOP to PMitCEBO with or without G-CSF in patients aged 60 plus with aggressive non-Hodgkin's lymphoma.", "Randomized, double-blind, placebo-controlled, phase III study of recombinant human granulocyte-macrophage colony-stimulating factor as adjunct to induction treatment of high-grade malignant non-Hodgkin's lymphomas.", "Short term treatment with Escherichia coli recombinant human granulocyte-macrophage-colony stimulating factor prior to chemotherapy for Hodgkin disease." ]

[ "To investigate whether the relative dose-intensity of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) chemotherapy could be improved by prophylactic administration of granulocyte colony-stimulating factor (G-CSF) in elderly patients with aggressive non-Hodgkin's lymphoma (NHL).\n Patients aged 65 to 90 years (median, 72 years) with stage II to IV aggressive NHL were randomly assigned to receive standard CHOP every 3 weeks or CHOP plus G-CSF every 3 weeks on days 2 to 11 of each cycle.\n In 389 eligible patients, the relative dose intensities (RDIs) of cyclophosphamide (median, 96.3% v 93.9%; P =.01) and doxorubicin (median, 95.4% v 93.3%; P =.04) were higher in patients treated with CHOP plus G-CSF. The complete response rates were 55% and 52% for CHOP and CHOP plus G-CSF, respectively (P =.63). The actuarial overall survival at 5 years was 22% with CHOP alone, compared with 24% with CHOP plus G-CSF (P =.76), with a median follow-up of 33 months. Patients treated with CHOP plus G-CSF had an identical incidence of infections, with World Health Organization grade 3 to 4 (34 of 1,191 cycles v 36 of 1,195 cycles). Only the cumulative days with antibiotics were fewer with CHOP plus G-CSF (median, 0 v 6 days; P =.006) than with CHOP alone. The number of hospital admissions and the number of days in hospital were not different.\n In elderly patients, G-CSF improved the RDI of CHOP, but this did not lead to a higher complete response rate or better overall survival. G-CSF did not prevent serious infections.", "Age is an important prognostic parameter, especially in patients with advanced high-grade non-Hodgkin's lymphoma (HG-NHL) who require more intensive and extensive therapy for any possible chance of cure. We investigated the potential of granulocyte colony-stimulating factor (G-CSF) for reducing myelotoxicity, which is the most important dose-limiting factor for chemotherapy. Between March 1993 and June 1995, 158 previously untreated patients 60 years and older with HG-NHL were included in a cooperative randomized comparative trial and treated with a combination therapy including VNCOP-B (cyclophosphamide, mitoxantrone, vincristine, etoposide, bleomycin, and prednisone) with or without G-CSF. G-CSF was administered at 5 microg/kg/d throughout the treatment starting on day 3 of every week for 5 consecutive days. Of the 158 patients registered for the trial, 149 patients were evaluable: 77 received VNCOP-B plus G-CSF and 72 received VNCOP-B alone. The overall response rate was 81.5%, with complete response in 59%: 60% in the VNCOP-B plus G-CSF group, and 58% in the VNCOP-B group. At 30 months (median 24 months), 68% of all complete responders were alive without disease in the G-CSF group and 65% in the control group. Neutropenia occurred in 18 out of 77 (23%) of the G-CSF treated patients and in 40 out of 72 (55.5%) of the controls (P = .00005). Clinically relevant infections occurred in 4 out of 77 (5%) of the G-CSF group and in 15 out of 72 (21%) of the controls (P = .004). The delivered dose intensity was higher in patients receiving G-CSF (95% v 85%), but the difference was not statistically significant. Our data show that VNCOP-B is a feasible and effective regimen in elderly HG-NHL patients, and that the use of G-CSF reduces infection and neutropenia rates without producing any significant modifications to the dose intensity, CR rate, and relapse-free survival curve.", "Age is a risk factor and a prognostic parameter in elderly aggressive-histology non-Hodgkin's lymphoma (NHL) patients. Several adapted chemotherapeutic regimens have recently been designed and tested on elderly patients. Several of these trials have shown that older aggressive-histology NHL patients can benefit from specific and adequate treatment capable of curing a percentage of these patients. Between January 1992 and September 1997, 350 previously untreated aggressive-histology NHL patients greater than 60 years of age were treated with a combination therapy including cyclophosphamide, mitoxantrone, vincristine, etoposide, bleomycin, and prednisone (VNCOP-B). Complete remission (CR) was achieved by 202 (58%) patients and partial remission (PR) by 87 (25%), whereas the remaining 61 (17%) patients were nonresponders. The overall response rate (CR + PR) was 83%. Clinical and hematologic toxicities were modest, because 71% of the patients received granulocyte colony-stimulating factor (G-CSF). The CR rates for the three age groups (60 to 69, 70 to 79, and >/=80 years) were similar: 61%, 59%, and 56%, respectively. At 5 years, the relapse-free survival rate was 65%, the overall survival rate was 49%, and the failure-free survival rate was 33%. In the multivariate analysis, prognostic factors associated with longer survival or longer relapse-free survival turned out to be localized disease stage (P =.001) and good performance status (P =.0002). Application of the International Prognostic Factor Index was significantly associated with outcome (P =.001). These data confirm on a large cohort of patients that the VNCOP-B regimen is effective in inducing good CR and relapse-free survival rates with only moderate toxic effects in elderly aggressive-histology NHL.", "The effect of granulocyte colony-stimulating factor (G-CSF) on neutropenia, infection, and cytotoxic chemotherapy administration was studied in a randomized trial in patients receiving intensive weekly chemotherapy for non-Hodgkin's lymphoma (NHL). Eighty patients (aged 16 to 71 years) with high-grade NHL (Kiel) of any stage were randomized to receive VAPEC-B chemotherapy alone (39 patients) or with G-CSF administered as a daily subcutaneous dose of 230 micrograms/m2 (41 patients). Prophylactic ketoconazole and cotrimoxazole were administered to all patients throughout treatment. The protocol specified identical dose modification and antibiotic treatment criteria bor both groups. Neutropenia (absolute neutrophil count [ANC] less than 1.0 x 10(9)/L) occurred in 15 of 41 (37%) of the G-CSF-treated patients and in 33 of 39 (85%) of the controls, giving a relative risk for control patients of 2.31 (95% confidence interval [CI], [1.51, 3.54]; P = .00001). Fever (greater than or equal to 37.5 degrees C) with neutropenia (ANC less than 1.0 x 10(9)/L) occurred in 9 of 41 (22%) of the G-CSF group and in 17 of 39 (44%) of the controls (relative risk for control, 2.26; 95% CI [1.01, 5.06]; P = .04). There were fewer treatment delays, with shorter duration (P = .01) in patients receiving G-CSF. Chemotherapy doses were reduced in 4 of 41 (10%) of the G-CSF patients and 13 of 39 (33%) of the controls (P = .01). The dose intensity of cytotoxic chemotherapy was significantly increased in patients receiving G-CSF (median of 95% in G-CSF group compared with 83% in control patients). Three vascular deaths occurred in the G-CSF group. Delays in the control group most commonly resulted from neutropenia (19 patients, compared with 2 patients in the G-CSF-treated group, P = .000007). Severe mucositis was the major dose-limiting toxicity in G-CSF-treated patients, but did not occur more frequently than in controls (15 patients in each group). Overall, patients randomized to receive G-CSF achieved a greater dose intensity than control patients, but this did not result in significant differences in drug toxicity (other than neutropenia), intravenous antibiotic usage, or hospitalization between the two groups.", "A prospective economic analysis of lenograstim and placebo was performed as part of a randomised double-blind trial in 162 patients receiving chemotherapy for non-Hodgkin's lymphoma (NHL). The primary clinical end-point was the percentage of patients experiencing > or = 1 documented infection in each treatment group. The cost of hospitalisation and the cost of medical services used were the primary economic end-points. Economic analysis was based on the French Hospital perspective. Over the 56-day study period, patients in the placebo group received more days of inpatient intravenous (8.9 vs 5.3 days; p < 0.01) and oral (5.3 vs 4.2 days) antibiotic therapy than those in the lenograstim group. This difference was due to a higher rate of documented infection in the placebo group. Patients treated with placebo also spent more days in hospital for reasons other than administration of chemotherapy (18.5 vs 14.4; p < 0.05). The number of days of chemotherapy was significantly greater in the lenograstim group than in the placebo group (19.4 vs 17.5; p < 0.001) because of shorter delays between chemotherapy cycles in the lenograstim group. The use of lenograstim to prevent chemotherapy-induced neutropenia in patients with NHL was associated with a reduction in total direct medical costs (excluding the cost of lenograstim) of FF7297 as a result of reduced patient morbidity. Furthermore, the higher rate of completion of chemotherapy in the lenograstim group may lead to better long term survival; this observation deserves further clinical investigation.", "We investigated whether Granulocyte colony-stimulating factor (G-CSF) could prevent myelotoxicity or accelerate hematopoietic recovery after intensive chemotherapy in previously untreated patients with diffuse large cell lymphoma (DLCL). Forty-two patients were included in a prospective clinical trial in which alternating chemotherapy ESAP (etoposide, Solu-Medrol, cytosine arabinoside, cis-platinum), m-BECOD (low doses methotrexate, bleomycin, epirubicin, cyclophosphamide, vincristine, dexamethasone), MVPP-Bleo (mitoxantrone, vincristine, prednisone, procarbazine, bleomycin) were administered by 9 cycles. Each cycle was followed by 10 days of G-CSF (5 micrograms/kg/day) started five days after chemotherapy compared to a control group which received chemotherapy without G-CSF support. Leucocytes and granulocytes were significantly higher in patients receiving G-CSF compared to the control group. The total number of days of leukopenia (WBC counts below 2.0 x 10(9)/L and absolute granulocytes below 1.0 x 10(9)/L) were longer in the patients without G-CSF compared to those who received G-CSF (14.1 days versus 1.9 days). Delays in treatment were most frequent in the control group: 38% versus 4% in all cycles. Infection episodes occurred in 41 out of 168 cycles (25%) in the control group compared to 7 out of 172 (4%) in the G-CSF arm. Complete response was achieved in 12 out of 22 (54%) in the control group compared to 16 out 20 (80%) in the patients who received G-CSF. Toxicity secondary to G-CSF was mild. G-CSF can be administered safely to patients with DLCL and results in improved hematologic recovery after intensive chemotherapy.(ABSTRACT TRUNCATED AT 250 WORDS)", "The purpose of this study was to, assess the efficacy of glycosylated recombinant human granulocyte colony-stimulating factor (lenograstim) in the prevention of neutropenia and infection in patients receiving dose-intensive chemotherapy for non-Hodgkin's lymphoma (NHL). A second objective was to determine clinical predicators of delay to cytotoxic chemotherapy administration. One hundred-sixty two patients with intermediate- or high-grade NHL and at least one poor prognostic factor received a total of 4 cycles of the LNH-84-regimen every 2 weeks, with an open randomization to treatment with anthracyclines. Patients were randomized to receive subcutaneous lenograstim 5 micrograms/kg/day (n = 82) or placebo (n = 80) from day 6 to day 13 of each cycle. The incidence of severe neutropenia (absolute neutrophil count (ANC) < 0.5 x 10(9)/L) was reduced in the lenograstim group compared with placebo (52% vs 75%). A significant reduction (p < 0.001) in the median duration of ANC < 0.5 x 10(9)/L was also observed in patients treated with lenograstim during each cycle of chemotherapy (0-1 day vs 2-4 days in placebo recipients). Fever occurred in 66 patients in each treatment group. Thirty-four percent of placebo recipients had documented infections during ANC < 1.0 x 10(9)/L compared with 18.5% of lenograstim-treated patients (p < 0.05). Infections of > or = 2 severity were significantly less frequent (p = 0.001) among lenograstim recipients compared with placebo (25 vs 49). The most common adverse events among lenograstim recipients were headache, mild bone pain and injection site reactions. Although lenograstim significantly increased (p = 0.0001) relative dose intensity compared with placebo (93% vs 80%), no difference in CR rate (67% vs 71%) or 3-year survival (63% vs 55%) was observed. The results of this study suggest that patients treated with a chemotherapy regimen that induces severe neutropenia can benefit from treatment with lenograstim. Furthermore, lenograstim permits treatment to be delivered at full dose intensity at 2 week intervals, even in patients with bone marrow involvement, and may permit further dose escalation of the chemotherapeutic regimen used.", "In high-grade malignant non-Hodgkin's lymphomas (hNHL) recombinant human granulocyte-macrophage colony-stimulating factor (rhGM-CSF) was evaluated as support to chemotherapy. In a phase III trial, 172 patients (age 18-73 years, stage II-IV) were risk-stratified according to LDH levels and lymphoma size and randomized to receive rhGM-CSF (400 micrograms) (87 patients) or placebo (85 patients) subcutaneously days 8-14 of each cycle of an intensified COP-BLAM regimen. RhGM-CSF significantly reduced the length and nadir of neutropenia, the length of fever episodes, the frequency of all and of severe infections, and of hospitalization and antibiotic requirements. Complete response rates were 63% for all patients and 64% vs. 61% (n.s.) in the rhGM-CSF vs. the control group. Deviations from protocol in applied dosages of myelotoxic drugs and in cycle intervals maintained differed slightly in favor of the rhGM-CSF arm. However, there were no significant differences in overall survival between the GM-CSF treatment and control groups (21 vs. 23 months). Early relapse rates were markedly lower than in the standard-dose COP-BLAM/IMVP-16 regimen. Thus, GM-CSF abates toxic side effects of chemotherapy and may help to maintain dose intensity in high-risk hNHL.", "Primary end point of this trial was to reduce neutropenic infections during the treatment of aggressive NHL with CEOP/IMVP-Dexa (cyclophosphamide, epirubicin, vincristine, prednisolone ifosfamide, methotrexate, VP-16, and dexamethasone). Further, we studied the influence of filgrastim on dose intensity of CEOP/IMVP-Dexa, on the rate of complete remissions, on the time to relapse, and on survival. Eighty-five patients with untreated large-cell NHL were randomized to one of two treatment arms; 74 patients were eligible. Thirty-eight patients in arm 1 were treated with CEOP/IMVP-Dexa chemotherapy and filgrastim, 36 in arm 2 with CEOP/IMVP-Dexa chemotherapy alone. In arm 1 filgrastim was self-injected by the patients at 5 micrograms/kg body wt. s.c. daily, except on the days when cytotoxic drugs were given. During treatment we did weekly complete blood counts. Median leukocyte counts were 10.91 x 10(9)/l and 5.46 x 10(9)/l in arm 1 and 2, respectively (p = 10(-6)). Median neutrophil counts were 7.7 x 10(9)/l in arm 1 and 2.72 x 10(9)/l in arm 2 (p < 10(-6)). Median neutrophil nadirs were 0.199 x 10(9)/l and 0.213 x 10(9)/l in arm 1 and 2, respectively (p = 0.09). Mean platelet nadirs were 95 and 152 x 10(9)/l (p = 0.000004) and mean hemoglobin nadirs 83.95 g/l and 92.78 g/l (p = 0.00558) in arm 1 and 2, respectively. Dose intensity of CEOP/IMVP-Dexa was 82.3% and 76.2% in arm 1 and 2, respectively (p = 0.041). Forty-two percent and 58% of patients experienced a febrile neutropenia in arm 1 and 2, respectively (not significant, NS). Median time to first neutropenic infection was in treatment week 11 and 6 in arm 1 and 2, respectively (NS). There was no significant difference in rate, duration, and kind of infection, duration of hospitalization, or antibiotic treatment. Seven toxic deaths occurred, all due to neutropenic infection, 6 and 1 in arm 1 and 2, respectively (p = 0.0732). Four of the six patients, who died of infection in arm 1 were older than 60 years. Complete remission rate was 83% and 66.7% in arm 1 and 2, respectively (NS). After a median observation time of 3 years there was no difference in time to relapse or survival. Filgrastim increases leukocyte and neutrophil counts and dose intensity, if used with CEOP/IMVP-Dexa chemotherapy in high-grade lymphomas. There was no significant effect on febrile neutropenia or infections. The more frequent fatal neutropenic infection rate in the filgrastim arm was not statistically significant. It is most appropriate to explain it by the patient's age in combination with the high dose intensity. The small increase in dose intensity had no effect on survival but probably decreased hemoglobin levels and platelet counts in arm 1. We were unable to show a benefit for filgrastim in combination with CEOP/IMVP-Dexa.", "Secondary central nervous system (CNS) involvement by aggressive lymphoma is a well-known and dreadful clinical complication. The incidence and risk factors for CNS manifestation were studied in a large cohort of elderly (>60 years) patients with aggressive lymphoma.\n In all, 444 previously untreated patients were randomized to receive 3-weekly combination chemotherapy with cyclophosphamide, doxorubicin, vincristine and prednisone or cyclophosphamide, mitoxantrone, vincristine and prednisone (CNOP) (doxorubicin substituted by mitoxantrone) chemotherapy with or without filgrastim. Prophylactic intrathecal methotrexate was given to patients with lymphoma involvement of bone marrow, testis and CNS near sites.\n In all 29 of 444 (6.5%) developed CNS disease after a median observation time of 115 months. CNS was the only site of progression/relapse in 13 patients while part of a systemic disease manifestation in 16 patients. In univariate risk factor analysis, CNS occurrence was associated with extranodal involvement of testis (P = 0.002), advanced clinical stage (P = 0.005) and increased age-adjusted International Prognostic Index score (aaIPI; P = 0.035). In multivariate analysis, initial involvement of testis remained significant and clinical stage was of borderline significance. The median survival time was 2 months after presentation of CNS disease.\n A significant proportion of elderly patients with advanced aggressive lymphoma will develop CNS disease. CNS occurrence is related to testis involvement, advanced clinical stage and high aaIPI and the prognosis is dismal.", "This study was intended to ascertain whether the adjunctive administration of filgrastim (r metHuG-CSF, Amgen) would influence the dose intensity of chemotherapy or the morbidity of myelosuppression in patients receiving MOPP or MOPP/EVAP hybrid chemotherapy for Hodgkin's disease. In a prospective randomized trial, two regimens for the treatment of Hodgkin's disease were compared. The substudy described here randomized patients receiving either regimen to receive filgrastim on the days when chemotherapy was not administered. During chemotherapy, parameters of myelosuppression were documented, including dose delays, the severity and duration of neutrophil and platelet nadirs, infective episodes, and resulting hospital admissions. In the MOPP arm, 13/25 eligible patients, and, in the MOPP/EVAP arm, 12/22 eligible patients, received filgrastim. The use of filgrastim made no statistically significant difference to the administered dose intensity for either MOPP (P = 0.57, 95% confidence interval (CI) 15-point increase to 8-point reduction) or MOPP/EVAP (P = 0.53; 95% CI 7-point increase to 11-point reduction). In patients receiving MOPP, filgrastim reduced the median duration of leucopenia (P = 0.007) and the severity of the white blood cell nadir (P = 0.036); however, no statistically significant effect (at the 5% level) was seen in platelet or haemoglobin nadirs, the number of days of in-patient hospitalization, the number of admissions for infective complications, the incidence, grade or duration of infections, or the incidence of febrile neutropenia. In patients receiving MOPP/EVAP, filgrastim had no significant effect on the duration or depth of leucopenia but was associated with a reduction in the median haemoglobin (P = 0.002) and platelet nadirs (P = 0.015). No effect on the above listed sequelae of myelosuppression was influenced by the administration of filgrastim. This study, although small, suggests that the routine use of filgrastim, aimed at influencing the administered dose intensity of conventional dose chemotherapy in Hodgkin's disease, is not warranted.", "nan", "The management of older patients with aggressive non-Hodgkin's lymphoma presents a challenge to the physician. Age is a poor prognostic indicator, due to reduced ability to tolerate and maintain dose-intensive chemotherapy. Generally, older patients demonstrate a lower response rate, reduced survival and increased toxicity, although the majority of large randomised trials exclude older patients. This randomised trial was conducted in patients 60 years or over to compare CHOP (cyclophosphamide 750 mg m(-2), doxorubicin 50 mg m(-2), vincristine 1.4 mg m(-2), prednisolone 100 mg) with PMitCEBO (mitoxantrone 7 mg m(-2), cyclophosphamide 300 mg m(-2), etoposide 150 mg m(-2), vincristine 1.4 mg m(-2), bleomycin 10 mg m(-2) and prednisolone 50 mg). Due to the myelosuppressive nature of these regimens, patients were also randomised to the addition of G-CSF. The formal results of this trial with long-term follow-up are now reported. Data were analysed to assess efficacy and toxicity. Overall response rate was 84% in the CHOP arm and 83% in the PMitCEBO arm, with overall response rates of 83% for the use of G-CSF and 84% for no G-CSF. At median 44 months follow-up, there was no significant difference in failure-free, progression-free or overall survival between the CHOP and PMitCEBO arms. At 3 years, the actuarial failure-free survival was 44% in CHOP recipients and 42% in PMitCEBO recipients and the 3-year actuarial overall survival was 46% and 45% respectively. There was no significant difference in the failure-free, progression-free or overall survival with the addition of G-CSF.", "We evaluated recombinant human granulocyte-macrophage colony-stimulating factor (rhGM-CSF; Sandoz Pharma [Basel, Switzerland]/Schering-Plough [Kenilworth, NJ]) as an adjunct to a modified (mainly cyclophosphamide and doxorubicin increased 1.5-fold) COP-BLAM regimen in the primary treatment of high-grade malignant non-Hodgkin's lymphomas (NHL). Patients (n = 182; stage II-IV; age, 15 to 73 years) were randomized to rhGM-CSF (400 micrograms) or placebo for 7 days subcutaneously after chemotherapy. Efficacy was analyzed for patients receiving at least 70% of study medication (n = 125). The frequency of clinically relevant infection was reduced by rhGM-CSF (28 v 69 infections, 16 v 30 patients, P = .02) with a cumulative probability of remaining infection free in 70% versus 48% (P = .05 log rank test at 190 days). Periods of neutropenia (P = .01 in 5 of 6 courses), days with fever (2.1 v 4.0, P = .04) and days of hospitalization for infection (3.5 v 8.0 days, P = .01) were significantly reduced. Complete response (CR) rates, assessed by prognostic risk, were 15 of 19 (79%) in treated versus 20 of 21 (95%) in controls in the low-risk group (P = .12). In the high-risk group, 31 of 45 (69%) treated patients achieved CR versus 25 of 52 (48%) of controls (P = .04). No difference in survival has been seen after 1 year. Only injection site reactions (45% treated v 7% controls) and rash (26% v 2%) occurred more frequently in treated patients (n = 176). These data show that rhGM-CSF is well tolerated in most patients with NHL, significantly reduces infection, and improves response.", "Granulocyte-macrophage-colony stimulating factor (GM-CSF) administration stimulates the proliferation of hemopoietic progenitors. Shortly (48-96 hours) after its discontinuation, feedback phenomena occur and the progenitor proliferation rate drops below baseline levels. As the quiescence of hyperplastic bone marrow suggests that hemopoietic cells may be refractory to the toxic effects of cytostatic drugs, the decision was made to test the hypothesis that GM-CSF given before chemotherapy may be myeloprotective.\n Fifty-six patients with newly diagnosed Stage II-IV Hodgkin disease, ages 18-77 years, were randomized to receive GM-CSF (5 microg/kg subcutaneously) or placebo from Day 7 to Day 4 before each chemotherapy administration (6 cycles of a hybrid of mechlorethamine, vincristine, procarbazine, and prednisone with doxorubicin, bleomycin, vinblastine, and dacarbazine). The treatment was considered a success if the delivery rate of chemotherapy was >90% after 3 cycles and >80% after 6 cycles.\n Thirty patients received GM-CSF and 26 placebo. The dose intensity (85.2% vs. 79.6%) and the overall success in terms of delivery rate (56.7% vs. 50%) were higher in the GM-CSF group, although these differences were not statistically significant. The neutrophil nadirs were higher in the GM-CSF group during the first three cycles and subsequently similar in both groups.\n No significant differences in terms of myelotoxicity or drug delivery were observed between the two treatment arms. Although the myeloprotective effect of the prechemotherapy administration of GM-CSF seems to be minimal, the data indicate a safe timing between GM-CSF discontinuation and further chemotherapy. Because cumulative myelotoxicity has been observed with other growth factors, given in the interval between the chemotherapy cycles, this may be relevant to the planning of rapid cycling.\n Copyright 2000 American Cancer Society." ]

[ "9756581", "12920254", "19841835", "18633001" ]

[ "A randomized, controlled pilot study of a home-based exercise program for individuals with mild and moderate stroke.", "Randomized clinical trial of therapeutic exercise in subacute stroke.", "Exercises for paretic upper limb after stroke: a combined virtual-reality and telemedicine approach.", "Satisfaction with care in post-stroke patients undergoing a telerehabilitation programme at home." ]

[ "BACKGROUND and\n Many stroke survivors have minimal to moderate neurological deficits but are physically deconditioned and have a high prevalence of cardiovascular problems; all of these are potentially modifiable with exercise. The purposes of this randomized, controlled pilot study were (1) to develop a home-based balance, strength, and endurance program; (2) to evaluate the ability to recruit and retain stroke subjects; and (3) to assess the effects of the interventions used.\n Twenty minimally and moderately impaired stroke patients who had completed inpatient rehabilitation and who were 30 to 90 days after stroke onset were randomized to a control group or to an experimental group that received a therapist-supervised, 8-week, 3-times-per-week, home-based exercise program. The control group received usual care as prescribed by the patients' physicians. Baseline and postintervention assessments included the Fugl-Meyer Motor Assessment, the Barthel Index of Activities of Daily Living (ADL), the Lawton Scale of Instrumental ADL, and the Medical Outcomes Study-36 Health Status Measurement. Functional assessments of balance and gait included a 10-m walk, 6-Minute Walk, and the Berg Balance Scale. Upper extremity function was evaluated by the Jebsen Test of Hand Function.\n Of 22 patients who met study criteria, 20 completed the study and 2 refused to participate. The experimental group tended to improve more than the control group in motor function (Fugl-Meyer Upper Extremity: mean change in score, 8. 4 versus 2.2; Fugl-Meyer Lower Extremity: 4.7 versus -0.9; gait velocity: median change, 0.25 versus .09 m/s; 6-Minute Walk: 195 versus 114 ft; Berg Balance Score: 7.8 versus 5; and Medical Outcomes Study-36 Health Status Measurement of Physical Function: 15. 5 versus 9). There were no trends in differences in change scores by the Jebsen Test of Hand Function, Barthel Index, and Lawton Instrumental ADL Scale.\n This study demonstrated that a randomized, controlled clinical trial of a poststroke exercise program is feasible. Measures of neurological impairments and lower extremity function showed the most benefit. Effects of the intervention on upper extremity dexterity and functional health status were equivocal. The lasting effects of the intervention were not assessed.", "Rehabilitation care after stroke is highly variable and increasingly shorter in duration. The effect of therapeutic exercise on impairments and functional limitations after stroke is not clear. The objective of this study was to determine whether a structured, progressive, physiologically based exercise program for subacute stroke produces gains greater than those attributable to spontaneous recovery and usual care.\n This randomized, controlled, single-blind clinical trial was conducted in a metropolitan area and 17 participating healthcare institutions. We included persons with stroke who were living in the community. One hundred patients (mean age, 70 years; mean Orpington score, 3.4) consented and were randomized from a screened sample of 582. Ninety-two subjects completed the trial. Intervention was a structured, progressive, physiologically based, therapist-supervised, in-home program of thirty-six 90-minute sessions over 12 weeks targeting flexibility, strength, balance, endurance, and upper-extremity function. Main outcome measures were postintervention strength (ankle and knee isometric peak torque, grip strength), upper- and lower-extremity motor control (Fugl Meyer), balance (Berg and functional reach), endurance (peak aerobic capacity and exercise duration), upper-extremity function (Wolf Motor Function Test), and mobility (timed 10-m walk and 6-minute walk distance).\n In the intention-to-treat multivariate analysis of variance testing the overall effect, the intervention produced greater gains than usual care (Wilk's lambda=0.64, P=0.0056). Both intervention and usual care groups improved in strength, balance, upper- and lower-extremity motor control, upper-extremity function, and gait velocity. Gains for the intervention group exceeded those in the usual care group in balance, endurance, peak aerobic capacity, and mobility. Upper-extremity gains exceeded those in the usual care group only in patients with higher baseline function.\n This structured, progressive program of therapeutic exercise in persons who had completed acute rehabilitation services produced gains in endurance, balance, and mobility beyond those attributable to spontaneous recovery and usual care.", "Telerehabilitation enables a remotely controlled programme to be used to treat motor deficits in post-stroke patients. The effects of this telerehabilitation approach were compared with traditional motor rehabilitation methods.\n Randomized single-blind controlled trial.\n A total of 36 patients with mild arm motor impairments due to ischaemic stroke in the region of the middle cerebral artery.\n The experimental treatment was a virtual reality-based system delivered via the Internet, which provided motor tasks to the patients from a remote rehabilitation facility. The control group underwent traditional physical therapy for the upper limb. Both treatments were of 4 weeks duration. All patients were assessed one month prior to therapy, at the commencement and termination of therapies and one month post-therapy, with the Fugl-Meyer Upper Extremity, the ABILHAND and the Ashworth scales.\n Both rehabilitative therapies significantly improved all outcome scores after treatment, but only the Fugl-Meyer Upper Extremity scale showed differences in the comparison between groups.\n Both strategies were effective, but the experimental approach induced better outcomes in motor performance. These results may favour early discharge from hospital sustained by a telerehabilitation programme, with potential beneficial effects on the use of available resources.", "We conducted a pilot telerehabilitation study with post-stroke patients with arm motor impairment. We compared the degree of satisfaction of patients undergoing a virtual reality (VR) therapy programme at home (Tele-VR group) to satisfaction experienced by those undergoing the same VR therapy in a hospital setting (VR-group). The rehabilitation equipment used a 3D motion tracking system to create a virtual environment in which the patient's movement was represented. In tele-therapy, the patient equipment was installed in their homes, connected to the hospital by four ISDN lines at a total bandwidth of 512 kbit/s. Rehabilitation data were transmitted via one line and videoconferencing via the other three. Ten patients with mild to intermediate arm motor impairment due to an ischaemic stroke, were randomized into VR or Tele-VR groups. A questionnaire was used at the end of treatment to measure each patient's degree of satisfaction. Tele-VR treated patients showed median values equal to or higher than the VR group patients in all 12 items investigated, except one. In motor performance, the Tele-VR group improved significantly (P < or = 0.05), while the VR group showed no significant change. Patients assigned to the Tele-VR group were able to engage in therapy at home and the videoconferencing system ensured a good relationship between the patient and the physical therapist whose physical proximity was not required." ]

[ "7966841", "2066170", "7659767", "9014918" ]

[ "Effects of smoking intervention and the use of an inhaled anticholinergic bronchodilator on the rate of decline of FEV1. The Lung Health Study.", "The effects of counseling on smoking cessation among patients hospitalized with chronic obstructive pulmonary disease: a randomized clinical trial.", "Behavioral anti-smoking trial in chronic obstructive pulmonary disease patients.", "Effect of diagnosis of \"smoker's lung\". RYLUNG Group." ]

[ "To determine whether a program incorporating smoking intervention and use of an inhaled bronchodilator can slow the rate of decline in forced expiratory volume in 1 second (FEV1) in smokers aged 35 to 60 years who have mild obstructive pulmonary disease.\n Randomized clinical trial. Participants randomized with equal probability to one of the following groups: (1) smoking intervention plus bronchodilator, (2) smoking intervention plus placebo, or (3) no intervention.\n Ten clinical centers in the United States and Canada.\n A total of 5887 male and female smokers, aged 35 to 60 years, with spirometric signs of early chronic obstructive pulmonary disease.\n Smoking intervention: intensive 12-session smoking cessation program combining behavior modification and use of nicotine gum, with continuing 5-year maintenance program to minimize relapse. Bronchodilator: ipratropium bromide prescribed three times daily (two puffs per time) from a metered-dose inhaler.\n Rate of change and cumulative change in FEV1 over a 5-year period.\n Participants in the two smoking intervention groups showed significantly smaller declines in FEV1 than did those in the control group. Most of this difference occurred during the first year following entry into the study and was attributable to smoking cessation, with those who achieved sustained smoking cessation experiencing the largest benefit. The small noncumulative benefit associated with use of the active bronchodilator vanished after the bronchodilator was discontinued at the end of the study.\n An aggressive smoking intervention program significantly reduces the age-related decline in FEV1 in middle-aged smokers with mild airways obstruction. Use of an inhaled anticholinergic bronchodilator results in a relatively small improvement in FEV1 that appears to be reversed after the drug is discontinued. Use of the bronchodilator did not influence the long-term decline of FEV1.", "Seventy-four cigarette-smoking patients admitted with COPD to the Chest Unit of a 600-bed teaching hospital served as subjects for a randomized trial of smoking cessation counseling. All patients were advised to quit smoking and smoking in the unit was not allowed. One-half of the patients were, in addition, provided with a self-help manual and three to eight 15- to 20-min counseling sessions on alternate days while in hospital. Self-reports of smoking status were obtained at 3 and 6 months, a sample of which were validated with serum COHb. The results were disappointing. Differences between the counseled group and the controls both in rates of cessation at 6 months (33.3% vs 21.4%) and, for patients still smoking, reductions in amount smoked would have lacked practical significance even if statistical significance had been obtained. Some alternative treatment approaches are suggested for this group of patients.", "Smoking causes chronic obstructive pulmonary disease (COPD), but few controlled studies have tested anti-smoking treatments in COPD. With procedures likely to attract unmotivated persons we recruited 49 quite-ill, smoking COPD patients. During one or two daily home visits for 85 days, breath carbon monoxide (CO) and self-reports of daily smoking were obtained. Patients, given quit dates and nicotine gum (2-mg pieces, up to 30 per day), were assigned randomly to three groups: Experimentals were reinforced with lottery tickets for CO < 10 ppm. Cigarette Self Report (CSR) patients were reinforced for reporting no smoking that day. Controls received non-contingent payments. Each group's mean CO level fell at the quit date. Thereafter, reinforced patients maintained significantly lower CO levels than Controls. Although many more 24-h abstentions occurred in the intervention period than in baseline, few patients sustained abstinence; the groups did not differ in that regard. Outcome was predicted by decisions to throw away cigarettes when intervention began, but not by motivation scales nor Fagerstrom dependence scores. Pay schedules apparently exaggerated self-reports of reduced smoking. Although results are statistically significant, there is still no proven, practical treatment for smoking in advanced COPD.", "nan" ]

[ "9756581", "15774435", "1559090", "12392332", "11812553", "15759530", "10030684", "15482247", "10768528", "5475721", "15704508", "8503751", "11588740", "9099186", "10945420", "12920254", "15293485" ]

[ "A randomized, controlled pilot study of a home-based exercise program for individuals with mild and moderate stroke.", "Comparison of Bobath based and movement science based treatment for stroke: a randomised controlled trial.", "Physiotherapy intervention late after stroke and mobility.", "Training symmetry of weight distribution after stroke: a randomized controlled pilot study comparing task-related reach, Bobath and feedback training approaches.", "Physiotherapy for patients with mobility problems more than 1 year after stroke: a randomised controlled trial.", "Efficacy of Bobath versus orthopaedic approach on impairment and function at different motor recovery stages after stroke: a randomized controlled study.", "Immediate effects of therapeutic facilitation on the gait of hemiparetic patients as compared with walking with and without a cane.", "A six-week, resource-efficient mobility program after discharge from rehabilitation improves standing in people affected by stroke: placebo-controlled, randomised trial.", "Task-related circuit training improves performance of locomotor tasks in chronic stroke: a randomized, controlled pilot trial.", "Effects of facilitation exercise techniques in stroke rehabilitation.", "Lateral weight transference exercises following acute stroke: a preliminary study of clinical effectiveness.", "Task-specific physical therapy for optimization of gait recovery in acute stroke patients.", "Comparing stroke rehabilitation outcomes between acute inpatient and nonintense home settings.", "Task-related training improves performance of seated reaching tasks after stroke. A randomized controlled trial.", "Bobath or motor relearning programme? A comparison of two different approaches of physiotherapy in stroke rehabilitation: a randomized controlled study.", "Randomized clinical trial of therapeutic exercise in subacute stroke.", "A task-orientated intervention enhances walking distance and speed in the first year post stroke: a randomized controlled trial." ]

[ "BACKGROUND and\n Many stroke survivors have minimal to moderate neurological deficits but are physically deconditioned and have a high prevalence of cardiovascular problems; all of these are potentially modifiable with exercise. The purposes of this randomized, controlled pilot study were (1) to develop a home-based balance, strength, and endurance program; (2) to evaluate the ability to recruit and retain stroke subjects; and (3) to assess the effects of the interventions used.\n Twenty minimally and moderately impaired stroke patients who had completed inpatient rehabilitation and who were 30 to 90 days after stroke onset were randomized to a control group or to an experimental group that received a therapist-supervised, 8-week, 3-times-per-week, home-based exercise program. The control group received usual care as prescribed by the patients' physicians. Baseline and postintervention assessments included the Fugl-Meyer Motor Assessment, the Barthel Index of Activities of Daily Living (ADL), the Lawton Scale of Instrumental ADL, and the Medical Outcomes Study-36 Health Status Measurement. Functional assessments of balance and gait included a 10-m walk, 6-Minute Walk, and the Berg Balance Scale. Upper extremity function was evaluated by the Jebsen Test of Hand Function.\n Of 22 patients who met study criteria, 20 completed the study and 2 refused to participate. The experimental group tended to improve more than the control group in motor function (Fugl-Meyer Upper Extremity: mean change in score, 8. 4 versus 2.2; Fugl-Meyer Lower Extremity: 4.7 versus -0.9; gait velocity: median change, 0.25 versus .09 m/s; 6-Minute Walk: 195 versus 114 ft; Berg Balance Score: 7.8 versus 5; and Medical Outcomes Study-36 Health Status Measurement of Physical Function: 15. 5 versus 9). There were no trends in differences in change scores by the Jebsen Test of Hand Function, Barthel Index, and Lawton Instrumental ADL Scale.\n This study demonstrated that a randomized, controlled clinical trial of a poststroke exercise program is feasible. Measures of neurological impairments and lower extremity function showed the most benefit. Effects of the intervention on upper extremity dexterity and functional health status were equivocal. The lasting effects of the intervention were not assessed.", "Bobath based (BB) and movement science based (MSB) physiotherapy interventions are widely used for patients after stroke. There is little evidence to suggest which is most effective. This single-blind randomised controlled trial evaluated the effect of these treatments on movement abilities and functional independence.\n A total of 120 patients admitted to a stroke rehabilitation ward were randomised into two treatment groups to receive either BB or MSB treatment. Primary outcome measures were the Rivermead Motor Assessment and the Motor Assessment Scale. Secondary measures assessed functional independence, walking speed, arm function, muscle tone, and sensation. Measures were performed by a blinded assessor at baseline, and then at 1, 3, and 6 months after baseline. Analysis of serial measurements was performed to compare outcomes between the groups by calculating the area under the curve (AUC) and inserting AUC values into Mann-Whitney U tests.\n Comparison between groups showed no significant difference for any outcome measures. Significance values for the Rivermead Motor Assessment ranged from p = 0.23 to p = 0.97 and for the Motor Assessment Scale from p = 0.29 to p = 0.87.\n There were no significant differences in movement abilities or functional independence between patients receiving a BB or an MSB intervention. Therefore the study did not show that one approach was more effective than the other in the treatment of stroke patients.", "To determine whether the intervention of a physiotherapist improved mobility in patients seen more than one year after stroke.\n Randomised crossover trial comparing two groups offered intervention by a physiotherapist, one immediately after entry into the trial and the other after a delay of three months. The intervention consisted of identifying problems and offering advice and help to solve the problems.\n Patients' homes in Oxfordshire.\n Patients who had reduced mobility due to a stroke more than one year before entry; 60 were recruited from a community stroke register and 34 in other ways.\n Standard measures of mobility including gait speed, functional ambulation categories, the Nottingham extended activities of daily living index, and individual items from the Barthel activities of daily living index and the Frenchay activities index. Measures of manual dexterity, depression, and anxiety were used as controls.\n 94 patients entered the trial and 49 were randomised to immediate and 45 to delayed physiotherapy; 89 were compared at the crossover point. At randomisation the two groups were comparable. At three months the group given early therapy showed an improvement in gait speed whereas the untreated group had declined (differences of -3.9 v 6.4 s to walk 10 m; p less than 0.01); between three and six months the group given delayed therapy showed improvement and the previously treated group declined (differences of 6.5 v -3.9 s to walk 10 m; p less than 0.01). A 9% (95% confidence interval 0% to 18%) decrease in time taken to walk 10 m was associated with treatment and a 12% (2% to 19%) increase when patients were untreated. Other measures did not change significantly.\n Intervention of an experienced physiotherapist late after stroke specifically improves mobility, albeit by a small amount, but the effects do not seem to be maintained, perhaps because there is an underlying decline in mobility in these patients. Gait speed offers a simple and sensitive measure of outcome.", "To determine (1) the most effective of three treatment approaches to retrain seated weight distribution long-term after stroke and (2) whether improvements could be generalized to weight distribution in standing.\n Inpatient rehabilitation unit.\n Forty asymmetrical acute stroke subjects were randomly allocated to one of four groups in this pilot study. Changes in weight distribution were compared between the 10 subjects of each of three treatment groups (task-specific reach, Bobath, or Balance Performance Monitor [BPM] feedback training) and a no specific treatment control group. One week of measurement only was followed by two weeks of daily training sessions with the treatment to which the subject was randomly allocated. Measurements were performed using the BPM daily before treatment sessions, two weeks after cessation of treatment and 12 weeks post study. Weight distribution was calculated in terms of mean balance (percentage of total body weight) or the mean of 300 balance points over a 30-s data run.\n In the short term, the Bobath approach was the most effective treatment for retraining sitting symmetry after stroke (p = 0.004). Training with the BPM and no training were also significant (p = 0.038 and p = 0.035 respectively) and task-specific reach training failed to reach significance (p = 0.26). At 12 weeks post study 83% of the BPM training group, 38% of the task-specific reach group, 29% of the Bobath group and 0% of the untrained group were found to be distributing their weight to both sides. Some generalization of symmetry training in sitting to standing was noted in the BPM training group which appeared to persist long term.\n Results should be treated with caution due to the small group sizes. However, these preliminary findings suggest that it might be possible to restore postural symmetry in sitting in the early stages of rehabilitation with therapy that focuses on creating an awareness of body position.", "Community physiotherapy is often prescribed for stroke patients with long-term mobility problems. We aimed to assess the effectiveness of this treatment in patients who had mobility problems 1 year after stroke.\n We screened 359 patients older than 50 years for a single-masked, randomised controlled trial to assess the effects of community physiotherapy. Assessments were made at baseline, 3, 6, and 9 months in 170 eligible patients assigned treatment or no intervention. The primary outcome measure was mobility measured by the Rivermead mobility index. Secondary outcome measures were gait speed, number of falls, daily activity (Barthel index scores), social activity (Frenchay activities index), hospital anxiety and depression scale, and emotional stress of carers (general health questionnaire 28). Analyses were by intention to treat.\n Follow-up was available for 146 patients (86%). Changes in scores on the Rivermead mobility index (score range 0-15) differed significantly between treatment and control groups at 3 months (p=0.018), but only by a median of 1 point (95% CI 0-1), with an interpolated value of 0.55 (0.08-1.04). Gait speed was 2.6 m/min (0.30-4.95) higher in the treatment group at 3 months. Neither treatment effect persisted at 6-months' and 9-months' follow-up. Treatment had no effect on patients' daily activity, social activity, anxiety, depression, and number of falls, or on emotional stress of carers.\n Community physiotherapy treatment for patients with mobility problems 1 year after stroke leads to significant, but clinically small, improvements in mobility and gait speed that are not sustained after treatment ends.", "To investigate the effectiveness of Bobath on stroke patients at different motor stages by comparing their treatment with orthopaedic treatment.\n A single-blind study, with random assignment to Bobath or orthopaedic group.\n Physical therapy department of a medical centre.\n Twenty-one patients with stroke with spasticity and 23 patients with stroke at relative recovery stages participated.\n Twenty sessions of Bobath programme or orthopaedic treatment programme given in four weeks.\n Stroke Impairment Assessment Set (SIAS), Motor Assessment Scale (MAS), Berg Balance Scale (BBS) and Stroke Impact Scale (SIS) for impairment and functional limitation level.\n Participants with spasticity showed greater improvement in tone control (change score: 1.20 +/- 1.03 versus 0.08 +/- 0.67, p = 0.006), MAS (change score: 7.64 +/- 4.03 versus 4.00 +/- 1.95, p = 0.011), and SIS (change score: 7.30 +/- 6.24 versus 1.25 +/- 5.33, p = 0.023) after 20 sessions of Bobath treatment than with orthopaedic treatment. Participants with relative recovery receiving Bobath treatment showed greater improvement in MAS (change score: 6.14 +/- 5.55 versus 2.77 +/- 9.89, p = 0.007), BBS (change score: 19.18 +/- 15.94 versus 6.85 +/- 5.23, p = 0.015), and SIS scores (change score: 8.50 +/- 3.41 versus 3.62 +/- 4.07, p = 0.006) than those with orthopaedic treatment.\n Bobath or orthopaedic treatment paired with spontaneous recovery resulted in improvements in impairment and functional levels for patient with stroke. Patients benefit more from the Bobath treatment in MAS and SIS scores than from the orthopaedic treatment programme regardless of their motor recovery stages.", "Although the neurodevelopmental technique (Bobath) is the most widely used approach in the gait rehabilitation of hemiparetic subjects in Europe, there is little neurophysiological evidence for its presumed effects on gait symmetry and facilitation of paretic muscles during the therapeutic intervention. The study, therefore, investigated the immediate effects of gait entrainment by a physical therapist on the gait of hemiparetic subjects.\n Cycle parameters, gait symmetry, hip joint movement and the electromyographic activity of several lower limb muscles were assessed in 22 patients during a classic intervention by five Bobath therapists and while walking with and without a cane.\n Multivariate statistics revealed that, while being assisted by the therapist, patients walked faster (P = 0.022), with a longer relative stance period of the affected leg (P = 0.005), a higher symmetry (P = 0.002), larger hip extension (P = 0.001) and more activation (P = 0.026) of the Mm. triceps surae, vastus lateralis, biceps femoris and gluteus medius as compared to walking with and without a cane. Extensor spasticity of the plantar-flexor tended to increase (n.s.). In five subjects, no after-effect could be documented 1 h after a gait training of 30 min.\n The study confirmed a more balanced walking pattern in conjunction with facilitation of various weight bearing muscles during the therapeutic intervention. A prolonged single stance period of the affected leg, an unobstructed hip movement, enhanced weight acceptance and a faster gait seemed to be responsible for the observed immediate effects of the therapeutic intervention.", "Although intervention is effective in reducing the disability associated with stroke, limited resources mean that physiotherapy services often cease by six months after stroke. The purpose of this clinical trial was to investigate the efficacy of resource-efficient physiotherapy services in improving mobility and quality of life after stroke. Twenty-six people with residual walking difficulties after stroke were randomised into an experimental or control group after discharge from physiotherapy services. The experimental group participated in a six-week, home-based mobility program. The control group participated in a six-week, home-based program of upper-limb exercises (i.e. 'sham' mobility exercises). Subjects met with the therapist for prescription of exercises only three times during the six weeks. Strategies used to offset potential problems associated with minimal subject-therapist interaction included videotaped instructions to encourage correct performance of exercises, modification of the environment and involvement of carers to enhance safety, and telephone contact and self-monitoring to promote compliance. Standing (Functional Reach), walking (MAS Item 5) and quality of life (SA-SIP30) were measured prior to, immediately after, and two months after intervention ceased by an assessor who was blinded to group allocation. Subjects in the experimental group demonstrated significant improvement in standing compared to the control group (p = 0.01) which was maintained two months after the cessation of intervention (p = 0.04). There was no difference between the groups in walking (p = 0.50) or quality of life (p = 0.70). The six-week, resource-efficient mobility program was effective in improving some of the mobility in people after discharge from stroke rehabilitation. The provision of resource-efficient programs is recommended wherever possible so that people affected by stroke may continue rehabilitation for longer.", "To evaluate the immediate and retention effects of a 4-week training program on the performance of locomotor-related tasks in chronic stroke.\n Randomized, controlled pilot study with 2-month follow-up.\n Rehabilitation center.\n A convenience sample consisting of 12 chronic stroke subjects was used. Subjects were randomly assigned to the experimental or the control group. Three subjects withdrew from the study.\n Both experimental and control groups participated in exercise classes three times a week for 4 weeks. The exercise class for the experimental group focused on strengthening the affected lower limb and practicing functional tasks involving the lower limbs, while the control group practiced upper-limb tasks.\n Lower-limb function was evaluated by measuring walking speed and endurance, peak vertical ground reaction force through the affected foot during sit-to-stand, and the step test.\n The experimental group demonstrated significant immediate and retained (2-month follow-up) improvement (p < or = .05) compared with the control group in walking speed and endurance, force production through the affected leg during sit-to-stand, and the number of repetitions of the step test.\n The pilot study provides evidence for the efficacy of a task-related circuit class at improving locomotor function in chronic stroke.", "nan", "To evaluate a training programme aimed at improving lateral weight transference in patients following acute stroke to determine main treatment effects, if any, to inform the design of future studies.\n A single-blind randomized controlled trial.\n The Stroke Unit at The James Cook University Hospital, Middlesbrough, UK.\n Thirty-five patients with an acute stroke.\n All subjects received their usual care, including physiotherapy. The treatment group (n = 17) received 12 additional therapy sessions (over four weeks) comprising exercises aimed at improving lateral weight transference in sitting delivered by trained physiotherapy assistants.\n Measures of dynamic reaching, sitting and standing, and static standing balance were undertaken by a blind independent observer.\n Specific measures of weight displacement in standing and reaching, and timed standing up and sitting down did not detect any differences over time regardless of group. Neither were there any significant changes over time, except for sway during static standing (p < 0.01) and time to return to their original position during dynamic reaching (p = 0.01).\n A training programme aimed at improving lateral weight transference did not appear to enhance the rehabilitation of acute stroke patients. Improvements observed in postural control in standing and sitting may be attributable to usual care or natural recovery.", "A randomized controlled pilot trial was conducted to estimate the effects of early, intensive, gait-focused physical therapy on ambulatory ability in acute, stroke patients. Twenty-seven patients with middle cerebral artery infarct of thromboembolic origin confirmed by computed axial tomography scan were stratified and randomly assigned to the experimental group, to a control group that received early, intensive and conventional therapy, or to a group receiving routine conventional therapy that started later and was not intense. Assessments at entry, six weeks, and three and six months by independent evaluators permitted comparisons with reference to clinical measures of motor performance, balance, and functional capacity, and laboratory measures of gait movements. Group results at six weeks demonstrated that gait velocity was similar in the two conventional groups thereby eliminating the timing of the interventions as an important factor. At that point, gait velocity was faster in the experimental group. The difference translated into a moderate effect size of 0.58. The time dedicated to gait training but not to total therapy time was correlated (rs = 0.63) to gait velocity. This effect disappeared at three and six months after stroke. These pilot results justify planning a large trial to test the effectiveness of a therapeutic protocol that focuses on early and intense gait therapy in an effort to facilitate early ambulation following stroke.", "To compare outcomes in stroke survivors who received rehabilitation services in an acute inpatient rehabilitation setting (multidisciplinary rehabilitation team) with outcomes in survivors in a home-based setting (family caregivers, limited team supervision).\n Randomized clinical trial, with mean follow-up after 60 days.\n Inpatient rehabilitation setting and home-based settings.\n Sixty patients (age range, 43-80yr) who had a stroke between 1996 and 1999 and had been referred after medical stabilization, randomly divided into 2 groups: group 1, inpatient rehabilitation; group 2, home-based rehabilitation.\n Group 1: therapeutical and neuromuscular exercises with occupational therapy with professional supervision; group 2: conventional exercises with family caregiver and limited professional supervision.\n Spasticity was evaluated with the Ashworth Scale, motor status with Brunnstrom's stages, functional status with the FIM instrument, and cognitive status with the Mini-Mental State Examination before and after rehabilitation.\n Patients rehabilitated in acute inpatient settings had better motor, functional, and cognitive outcomes (p < .05). Spasticity changes did not differ between the groups.\n Intense inpatient rehabilitation services for stroke survivors provide significantly more favorable functional and cognitive outcomes with relatively low complications than did nonintense rehabilitation efforts in home settings.\n Copyright 2001 by the American Congress of Rehabilitation Medicine and the American Academy of Physical Medicine and Rehabilitation", "After stroke, the ability to balance in sitting is critical to independence. Although impairments in sitting balance are common, little is known about the effectiveness of rehabilitation strategies designed to improve it. The purpose of this randomized placebo-controlled study was to evaluate the effect of a 2-week task-related training program aimed at increasing distance reached and the contribution of the affected lower leg to support and balance.\n Twenty subjects at least 1 year after stroke were randomized into an experimental or control group. The experimental group participated in a standardized training program involving practice of reaching beyond arm's length. The control group received sham training involving completion of cognitive-manipulative tasks within arm's length. Performance of reaching in sitting was measured before and after training using electromyography, videotaping, and two force plates. Variables tested were movement time, distance reached, vertical ground reaction forces through the feet, and muscle activity. Subjects were also tested on sit-to-stand, walking, and cognitive tasks. Nineteen subjects completed the study.\n After training, experimental subjects were able to reach faster and further, increase load through the affected foot, and increase activation of affected leg muscles compared with the control group (P < .01). The experimental group also improved in sit-to-stand. The control group did not improve in reaching or sit-to-stand. Neither group improved in walking.\n This study provides strong evidence of the efficacy of task-related motor training in improving the ability to balance during seated reaching activities after stroke.", "To examine whether two different physiotherapy regimes caused any differences in outcome in rehabilitation after acute stroke.\n A double-blind study of patients with acute first-ever stroke. Sixty-one patients were consecutively included, block randomized into two groups, and stratified according to gender and hemiplegic site. Group 1 (33 patients) and group 2 (28 patients) had physiotherapy according to Motor Relearning Programme (MRP) and Bobath, respectively. The supplemental treatment did not differ in the two groups.\n The Motor Assessment Scale (MAS), the Sødring Motor Evaluation Scale (SMES), the Barthel ADL Index and the Nottingham Health Profile (NHP) were used. The following parameters were also registered: length of stay in the hospital, use of assistive devices for mobility, and the patient's accommodation after discharge from the hospital.\n Patients treated according to MRP stayed fewer days in hospital than those treated according to Bobath (mean 21 days versus 34 days, p = 0.008). Both groups improved in MAS and SMES, but the improvement in motor function was significantly better in the MRP group. The two groups improved in Barthel ADL Index without significant differences between the groups. However, women treated by MRP improved more in ADL than women treated by Bobath. There were no differences between the groups in the life quality test (NHP), use of assistive devices or accommodation after discharge from the hospital.\n The present study indicates that physiotherapy treatment using the MRP is preferable to that using the Bobath programme in the acute rehabilitation of stroke patients.", "Rehabilitation care after stroke is highly variable and increasingly shorter in duration. The effect of therapeutic exercise on impairments and functional limitations after stroke is not clear. The objective of this study was to determine whether a structured, progressive, physiologically based exercise program for subacute stroke produces gains greater than those attributable to spontaneous recovery and usual care.\n This randomized, controlled, single-blind clinical trial was conducted in a metropolitan area and 17 participating healthcare institutions. We included persons with stroke who were living in the community. One hundred patients (mean age, 70 years; mean Orpington score, 3.4) consented and were randomized from a screened sample of 582. Ninety-two subjects completed the trial. Intervention was a structured, progressive, physiologically based, therapist-supervised, in-home program of thirty-six 90-minute sessions over 12 weeks targeting flexibility, strength, balance, endurance, and upper-extremity function. Main outcome measures were postintervention strength (ankle and knee isometric peak torque, grip strength), upper- and lower-extremity motor control (Fugl Meyer), balance (Berg and functional reach), endurance (peak aerobic capacity and exercise duration), upper-extremity function (Wolf Motor Function Test), and mobility (timed 10-m walk and 6-minute walk distance).\n In the intention-to-treat multivariate analysis of variance testing the overall effect, the intervention produced greater gains than usual care (Wilk's lambda=0.64, P=0.0056). Both intervention and usual care groups improved in strength, balance, upper- and lower-extremity motor control, upper-extremity function, and gait velocity. Gains for the intervention group exceeded those in the usual care group in balance, endurance, peak aerobic capacity, and mobility. Upper-extremity gains exceeded those in the usual care group only in patients with higher baseline function.\n This structured, progressive program of therapeutic exercise in persons who had completed acute rehabilitation services produced gains in endurance, balance, and mobility beyond those attributable to spontaneous recovery and usual care.", "To evaluate the efficacy of a task-orientated intervention in enhancing competence in walking in people with stroke.\n Two-centre observer-blinded stratified block-randomized controlled trial.\n General community.\n Between May 2000 and February 2003, 91 individuals with a residual walking deficit within one year of a first or recurrent stroke consented to participate.\n The experimental intervention comprised 10 functional tasks designed to strengthen the lower extremities and enhance walking balance, speed and distance. The control intervention involved the practice of upper extremity activities. Subjects in both groups attended sessions three times a week for six weeks.\n Six-minute walk test (SMWT), 5-m walk (comfortable and maximum pace), Berg Balance Scale, timed 'up and go'.\n At baseline, subjects in the experimental (n = 44) and control (n = 47) groups walked an average distance of 209 m (SD = 126) and 204 m (SD =131), respectively, on the SMWT. Mean improvements of 40 m (SD =72), and 5 m (SD =66) were observed following the experimental and control interventions, respectively. The between-group difference was 35 m (95% confidence interval (CI) 7, 64). Significant between-group effects of 0.21 m/s (95% CI 0.12, 0.30) and of 0.11 m/s (95% CI 0.03, 0.19) in maximum and comfortable walking speed, respectively, were observed. People with a mild, moderate or severe walking deficit at baseline improved an average of 36 (SD =96), 55 (SD = 56) and 18 m (SD = 23), respectively, in SMWT performance following the experimental intervention.\n Study findings support the efficacy of a task-orientated intervention in enhancing walking distance and speed in the first year post stroke, particularly in people with moderate walking deficits." ]

[ "10955437", "10746845", "8293835", "11776507", "8794418", "10430010", "9031963", "14716182", "12873780", "1921739", "8605133" ]

[ "Oestradiol-releasing vaginal ring versus oestriol vaginal pessaries in the treatment of bothersome lower urinary tract symptoms.", "Comparison of usefulness of estradiol vaginal tablets and estriol vagitories for treatment of vaginal atrophy.", "Comparative study: Replens versus local estrogen in menopausal women.", "The effect of estradiol vaginal tablet and conjugated estrogen cream on urogenital symptoms in postmenopausal women: a comparative study.", "Replens versus dienoestrol cream in the symptomatic treatment of vaginal atrophy in postmenopausal women.", "Local treatment of urogenital atrophy with an estradiol-releasing vaginal ring: a comparative and a placebo-controlled multicenter study. Vaginal Ring Study Group.", "Continuous low dose estradiol released from a vaginal ring versus estriol vaginal cream for urogenital atrophy.", "Efficacy of low-dose intravaginal estriol on urogenital aging in postmenopausal women.", "Local estrogen treatment in patients with urogenital symptoms.", "Efficacy of sustained-release vaginal oestriol in alleviating urogenital and systemic climacteric complaints.", "A comparative study of safety and efficacy of continuous low dose oestradiol released from a vaginal ring compared with conjugated equine oestrogen vaginal cream in the treatment of postmenopausal urogenital atrophy." ]

[ "To assess the efficacy of an oestradiol-releasing vaginal ring and oestriol pessaries in the alleviation of lower urinary tract symptoms occurring after the menopause.\n Randomised, parallel group, controlled trial.\n Twenty-six clinics of practising gynaecologists and one outpatient clinic at a department of obstetrics and gynaecology.\n Two hundred and fifty-one postmenopausal women, with a mean age of 66 years, reporting at least one bothersome lower urinary tract symptom.\n One hundred and thirty-four women were treated with the oestradiol-releasing ring for 24 weeks; 117 women were treated with oestriol pessaries 0.5 mg every second day for 24 weeks.\n Subjective scores of urgency, frequency, nocturia, dysuria, stress incontinence and urge incontinence.\n The two treatments were equally efficacious in alleviating urinary urgency (51% vs 56%), urge incontinence (58% vs 58%), stress incontinence (53% vs 59%) and nocturia (51% vs 54%). Dysuria was alleviated in 76% vs 67%, equivalence was not demonstrated. No statistically significant difference was found for any primary efficacy endpoint. Sixty percent of the participants rated the form of administration via the vaginal ring as excellent, compared with 14% for the pessaries (P < 0.0001).\n Low dose vaginally administered oestradiol and oestriol are equally efficacious in alleviating lower urinary tract symptoms which appear after the menopause. The form of administration of the vaginal ring, seems to be more acceptable than oestriol pessaries.", "Atrophic vaginitis is a common condition. This study compared the usefulness of estradiol vaginal tablets (EVT) and estriol vagitories (EV) in treatment of atrophic vaginitis.\n Ninety-six postmenopausal women with symptoms of atrophic vaginitis were treated for 24 weeks with either EVT or with EV. Patients used the medication daily for the first 2 weeks of the study, and twice-weekly thereafter.\n Both EVT and EV were effective in treating vaginal atrophy and patients in both treatment groups experienced a significant improvement in vaginal symptoms such as itching, irritation, dryness, and dyspareunia. At the end of the study three (6%) EVT treated women reported leakage and none needed to use sanitary towels. Among the EV treated women 31 (65%) reported leakage and 14 (29%) required sanitary protection. Furthermore, 90% in the EVT group perceived the medication as hygienic compared to 79% in the EV group, and 49% in the EVT group indicated that the product was easy to use compared to 28% in the EV group. Endometrial thickness was increased (1.1 mm with EVT and 0.5 mm on EV) in both treatment groups during the first 2 weeks of the study, but returned to baseline levels when the frequency of drug application was reduced to twice-weekly.\n Estradiol vaginal tablets provides an effective alternative to traditional forms of local estrogen therapy.", "This was an open-label study comparing effects of a nonhormonal drug-free bioadhesive vaginal moisturizer to a local estrogen therapy in the treatment of vaginal dryness symptoms. There were 15 women evaluated in each treatment group during a 12-week period. Results indicated that the bioadhesive vaginal moisturizer was a safe and effective alternative to estrogen vaginal cream, with both therapies exhibiting statistically significant increases in vaginal moisture, vaginal fluid volume, and vaginal elasticity with a return of the premenopausal pH state.", "To compare the effects of estradiol vaginal tablet with conjugated estrogen cream on urogenital symptoms, vaginal health index, vaginal cytology, endometrial thickness, and plasma estradiol level in postmenopausal women.\n Fifty-three women with urogenital symptoms were randomized to local vaginal treatment of 25 microg estradiol tablet or 1 g of conjugated estrogen cream for 12 weeks. They were assessed for urogenital symptoms, vaginal health index, vaginal cytology, endometrial thickness and estradiol level.\n Forty-eight women completed the treatment. Both groups showed improvement of urogenital symptoms, vaginal health index, and vaginal cytology after the first 4 weeks of treatment. Conjugated estrogen cream showed superior efficacy in alleviating vaginal dryness and dyspareunia. Two cases of endometrial proliferation were noted.\n Estradiol vaginal tablet and conjugated estrogen cream were effective in treating urogenital symptoms, the restoration of normal vaginal epithelium and reduction of vaginal pH in postmenopausal women. However, 2 cases of endometrial proliferation were noted.", "This study was designed to evaluate the efficacy of Replens, a non-hormonal moisturizing vaginal gel, on symptoms of vaginal atrophy in postmenopausal women, in comparison with Dienoestrol (Cilag), an oestrogenic vaginal cream.\n Thirty-nine patients were randomly allocated to either of the two treatments. Replens was given three times a week during the 12 weeks of the study, while Dienoestrol was administered daily during the first 2 weeks and thereafter three times a week. Vaginal dryness index, itching, irritation, dyspareunia, pH and safety were evaluated every week the first month and every month thereafter.\n Both treatments had a significant increase on vaginal dryness index as soon as the first week of treatment, and the hormonal compound was significantly better than the non-hormonal one. All symptoms such as itching, irritation and dyspareunia significantly decreased or disappeared without any difference between the two treatments. For pH, no significant difference was seen either in each group or between the two groups. No adverse events related with the two drugs were found.\n This study shows that Replens applied vaginally three times a week, is a full therapy for all symptoms of vaginal atrophy as well as local estrogen. No serious adverse event was related. Replens is an alternative treatment to local estrogen and perhaps a good complement of systemic HRT in patient suffering from vaginal dryness.", "Local estrogen substitution has been shown to be more appropriate than any systemic application for the treatment of urogenital symptoms of hormone deficiency. The efficacy, safety and acceptability of a new low-dose drug delivery system consisting of an estradiol-releasing silicone vaginal ring was studied in two multicenter trials. In an open-label comparative trial a total of 219 postmenopausal women were randomized to the estradiol-releasing vaginal ring or to estriol suppositories. In terms of efficacy both treatment arms were shown to be equivalent; however, significantly higher rates of acceptability were found for the vaginal ring. In a double-blinded placebo-controlled study a total of 84 patients were randomized to either treatment arm for a period of 24 weeks. The statistically significant improvement of the vaginal epithelial pH and maturation values demonstrated the efficacy of the estradiol-releasing vaginal ring compared to the placebo ring.", "To determine if the efficacy of continuous low dose estradiol released from a vaginal ring is equivalent to estriol vaginal cream regarding improvement of the patient's subjective feeling of vaginal dryness and to determine if there is a preference for either of the two study treatments.\n Open-label randomized parallel group trial with active control with a blind evaluation of vaginal cytology and with a cross-over (change-over) phase for preference comparison. One hundred and sixty five postmenopausal women with symptoms of vaginal dryness and signs of vaginal atrophy were randomized to an estradiol ring (Estring) or estriol cream (Synapause). The duration of each treatment period was 12 weeks.\n Both study treatments were equally effective regarding the ability to alleviate the symptom feeling of vaginal dryness and the signs of vaginal atrophy. Both treatments were efficient in restoring the vaginal mucosa, recorded as higher maturation values and as decreased vaginal pH. Estring was superior to estriol cream regarding preference of treatment. Both treatments were equivalent for the occurrence of adverse events, including bleeding.\n data from this change-over study confirm efficacy and safety of both the vaginal ring and cream in the treatment of postmenopausal women with urogenital atrophy symptoms and signs. The patients had a strong preference for the vaginal ring.", "To assess the efficacy and safety of intravaginal estriol administration on urinary incontinence, urogenital atrophy, and recurrent urinary tract infections in postmenopausal women.\n Eighty-eight postmenopausal women with urogenital aging symptoms were enrolled in this prospective, randomized, placebo-controlled study. Participants were randomly divided into two groups, with each group consisting of 44 women. Women in the treatment group received intravaginal estriol ovules: 1 ovule (1 mg) once daily for 2 weeks and then 2 ovules once weekly for a total of 6 months as maintenance therapy. Women in the control group received inert placebo vaginal suppositories in a similar regimen. We evaluated urogenital symptomatology, urine cultures, colposcopic findings, urethral cytologic findings, urethral pressure profiles, and urethrocystometry before as well as after 6 months of treatment.\n After therapy, the symptoms and signs of urogenital atrophy significantly improved in the treatment group in comparison with the control group. Thirty (68%) of the treated participants, and only seven (16%) of the control participants registered a subjective improvement of their incontinence. In the treated participants, we observed significant improvements of colposcopic findings, and there were statistically significant increases in mean maximum urethral pressure, in mean urethral closure pressure as well as in the abdominal pressure transmission ratio to the proximal urethra. Urethrocystometry showed positive but not statistically significant modifications.\n Our results show that intravaginal administration of estriol may represent a satisfactory therapeutic choice for those postmenopausal women with urogenital tract disturbances who have contraindications or refuse to undergo standard hormone therapy.", "Determination of the efficacy and safety of vaginally administered low dose (25 microg) micronized 17beta-estradiol in the management of patients with urogenital symptoms.\n A total of 1612 patients with urogenital complaints were randomized to receive 25 microg of micronized 17beta-estradiol (n=828) or placebo (n=784) in a multicenter double-blind placebo-controlled study running for 12 months. Female patients were treated once a day over a period of 2 weeks, and then twice a week for the remaining of the 12 months with an active or placebo tablet. The assessment included full history-questionnaire, micturition diary, gynecologic and cystometric examination, transvaginal ultrasound, and serum 17beta-estradiol level determination. It was carried out at the beginning, and after 4 and 12 months of treatment.\n The overall success rate of micronized 17beta-estradiol and placebo on subjective and objective symptoms of postmenopausal women with vaginal atrophy was 85.5%, and 41.4%, respectively. A significant improvement of urinary atrophy symptoms was determined in vaginal ERT group as compared with the beginning of the study (51.9% vs. 15.5%, P=0.001). The maximal cystometric capacity (290 ml vs. 200 ml, P=0.023), the volume of the urinary bladder at which patients first felt urgency (180 vs. 140, P=0.048), and strong desire to void (170 ml vs. 130 ml, P=0.045) were significantly increased subsequent to the micronized 17beta-estradiol treatment. The number of patients with uninhibited bladder contractions significantly decreased following micronized 17beta-estradiol as compared with pretreatment values (17/30, P=0.013). Side effects were observed in 61 (7.8%) patients treated with low dose micronized 17beta-estradiol. Therapy with 25 microg of micronized 17beta-estradiol did not raise serum estrogen level nor stimulated endometrial growth.\n Local administration of 25 microg of micronized 17beta-estradiol is an effective and a safe treatment option in the management of women with urogenital complaints.", "In a double-blind, placebo-controlled study, 109 patients suffering from local and vasomotor postmenopausal complaints were randomly assigned to treatment with either depot vaginal suppositories containing 3.5 mg oestriol (E3) or a placebo. The treatment schedule comprised one vaginal suppository twice weekly for 3 weeks initially, followed by maintenance therapy with one vaginal suppository weekly for the 6-month study period. The effectiveness of the therapy was assessed on the basis of questionnaires (Kupperman index for vasomotor complaints and an original urogenital index for local complaints) and gynaecological examinations which included assessments of vaginal cytology, vaginal pH and Döderlein bacilli. To rule out induced endometrial proliferation, endometrial biopsies were performed in 50 women before and after the study. The vaginal depot (E3) formulation showed highly significant superiority over the placebo with respect to therapeutic effect on local urogenital complaints and alleviation of vasomotor complaints, including hot flushes. Analysis of the endometrial biopsies indicated that the monotherapy used caused no endometrial stimulation. Taking into account the minimal rate of adverse effects, the 3.5 mg E3 depot formulation studied represents a useful variant in the range of preparations available for the treatment of post-menopausal complaints.", "To compare the safety, efficacy and acceptability of a continuous low dose oestradiol releasing vaginal ring with conjugated equine oestrogen vaginal cream in the treatment of postmenopausal urogenital atrophy.\n An open, parallel, comparative multicentre trial.\n Sydney and Melbourne, Australia.\n One hundred and ninety-four postmenopausal women with symptoms and signs of urogenital atrophy were randomised on a 2:1 basis to 12 weeks of treatment with an oestrogen vaginal ring versus an oestrogen cream.\n Equivalence (95% CI) was demonstrated between the two treatments for relief of vaginal dryness and dyspareunia, resolution of atrophic signs, improvement in vaginal mucosal maturation indices and reduction in vaginal pH. No significant difference was demonstrated in endometrial response to a progestogen challenge test and equivalence was demonstrated in the incidence of intercurrent bleeding episodes. The vaginal ring was significantly more acceptable than the cream P < 0.0001), and was preferred to the cream (P < 0.001).\n With equivalent efficacy and safety and superior acceptability to vaginal cream, the low dose oestradiol vaginal ring is an advance in vaginal delivery systems for the treatment of urogenital atrophy." ]

[ "15834226" ]

[ "Impact of a workplace peer-focused substance abuse prevention and early intervention program." ]

[ "PeerCare is a workplace peer intervention program that focuses on changing workplace attitudes toward on-the-job substance use and trains workers to recognize, intervene with, and refer coworkers who have a problem.\n Monthly injuries at the study company (January 1983 through June 1996) were compared to counts at four other companies in the same industry. Using these panel data, fixed-effects negative binomial regression measured the association of the percentage of the workforce covered by PeerCare with the workplace injury rate.\n For every 1% increase in the workforce covered with PeerCare, the risk of injury declined by 0.9984 (95% confidence interval, 0.9975-0.9994). These findings suggest that, by June 1996, when 86% of the workforce was covered under PeerCare, the program had reduced injury rates by an average 14% per month.\n The findings support the implementation of peer intervention programs as a means to reduce workplace injuries." ]

[ "17085459" ]

[ "Effect of isoniazid prophylaxis on mortality and incidence of tuberculosis in children with HIV: randomised controlled trial." ]

[ "To investigate the impact of isoniazid prophylaxis on mortality and incidence of tuberculosis in children with HIV.\n Two centre prospective double blind placebo controlled trial.\n Children aged > or =8 weeks with HIV.\n Isoniazid or placebo given with co-trimoxazole either daily or three times a week.\n Two tertiary healthcare centres in South Africa.\n Mortality, incidence of tuberculosis, and adverse events.\n Data on 263 children (median age 24.7 months) were available when the data safety monitoring board recommended discontinuing the placebo arm; 132 (50%) were taking isoniazid. Median follow-up was 5.7 (interquartile range 2.0-9.7) months. Mortality was lower in the isoniazid group than in the placebo group (11 (8%) v 21 (16%), hazard ratio 0.46, 95% confidence interval 0.22 to 0.95, P=0.015) by intention to treat analysis. The benefit applied across Centers for Disease Control clinical categories and in all ages. The reduction in mortality was similar in children on three times a week or daily isoniazid. The incidence of tuberculosis was lower in the isoniazid group (5 cases, 3.8%) than in the placebo group (13 cases, 9.9%) (hazard ratio 0.28, 0.10 to 0.78, P=0.005). All cases of tuberculosis confirmed by culture were in children in the placebo group.\n Prophylaxis with isoniazid has an early survival benefit and reduces incidence of tuberculosis in children with HIV. Prophylaxis may offer an effective public health intervention to reduce mortality in such children in settings with a high prevalence of tuberculosis.\n Clinical Trials NCT00330304." ]

[ "18048633", "15533536", "17007707", "10731452", "16873594", "10800431", "11906689", "16298723", "18946771", "16548939", "12622686", "16182355", "9531235" ]

[ "The effectiveness and cost effectiveness of telephone counselling and the nicotine patch in a state tobacco quitline.", "The TEAM project: the effectiveness of smoking cessation intervention with hospital patients.", "A randomised controlled trial of motivational interviewing for smoking cessation.", "A randomized controlled trial of smoking cessation counseling after myocardial infarction.", "Integrated tobacco cessation counseling in a diabetes self-management training program: a randomized trial of diabetes and reduction of tobacco.", "A brief smoking cessation intervention for women in low-income planned parenthood clinics.", "Pilot evaluation of a population-based health intervention for reducing use of smokeless tobacco.", "Proactive, motivationally enhanced smoking cessation counseling among women with elevated cervical cancer risk.", "Smoking cessation among patients in an emergency chest pain observation unit: outcomes of the Chest Pain Smoking Study (CPSS).", "A smoking cessation intervention for the methadone-maintained.", "Pediatric-based smoking cessation intervention for low-income women: a randomized trial.", "Home health care nurses as a new channel for smoking cessation treatment: outcomes from project CARES (Community-nurse Assisted Research and Education on Smoking).", "Efficacy of a smoking cessation program for hospital patients." ]

[ "State and national tobacco quitlines have expanded rapidly and offer a range of services. We examined the effectiveness and cost effectiveness of offering callers single session versus multisession counselling, with or without free nicotine patches.\n This 3x2 randomised trial included 4614 Oregon tobacco quitline callers and compared brief (one 15-minute call), moderate (one 30-minute call and a follow-up call) and intensive (five proactive calls) intervention protocols, with or without offers of free nicotine patches (nicotine replacement therapy, NRT). Blinded staff assessed tobacco use by phone at 12 months.\n Abstinence odds ratios were significant for moderate (OR = 1.22, CI = 1.01 to 1.48) and intensive (OR = 1.29, CI = 1.07 to 1.56) intervention, and for NRT (OR = 1.58, CI = 1.35 to 1.85). Intent to treat quit rates were as follows: brief no NRT (12%); brief NRT (17%); moderate no NRT (14%); moderate NRT (20%); intensive no NRT (14%); and intensive NRT (21%). Relative to brief no NRT, the added costs for each additional quit was $2467 for brief NRT, $1912 for moderate no NRT, $2109 for moderate NRT, $2641 for intensive no NRT, and $2112 for intensive NRT.\n Offering free NRT and multisession telephone support within a state tobacco quitline led to higher quit rates, and similar costs per incremental quit, than less intensive protocols.", "This study evaluated the effectiveness of three smoking cessation interventions for this population: (1) modified usual care (UC); (2) brief advice (A); and (3) brief advice plus more extended counseling during and after hospitalization (A + C).\n Smokers (2,095) who were in-patients in four hospitals were randomly assigned to condition. Smoking status was ascertained via phone interview 7 days and 12 months post-discharge. At 12 months, reports of abstinence were validated by analysis of saliva cotinine. Intent to treat analyses were performed.\n At 7-day follow-up, 24.2% of participants reported abstinence in the previous 7 days. There were no differences between conditions. At 12-month follow-up, self-reported abstinence was significantly higher in the A + C condition (UC (15.0%) vs. A (15.2%) vs. A + C (19.8%)). There was no significant difference among conditions in cotinine-validated abstinence, however (UC (8.8%) vs. A (10.0%) vs. A + C (9.9%)).\n These interventions for hospital in-patients did not increase abstinence rates. Features of the study that might have contributed to this finding were the inclusiveness of the participation criteria, the fact that pharmacological aids were not provided, and a stage-matching approach that resulted in less intensive counseling for participants unwilling to set a quit date.", "Motivational interviewing is a technique used to promote change in addictive behaviour, initially used to treat alcoholism. Despite this, its effectiveness has not been sufficiently demonstrated for giving up smoking.\n The aim of the study was to establish whether motivational interviewing, compared with anti-smoking advice, is more effective for giving up the habit.\n Randomised controlled trial.\n Primary care in Albecete, Spain.\n Random experimental study of 200 smokers assigned to two types of interventions: anti-smoking advice (n = 86) and motivational interviewing (n = 114). Subjects in both groups were offered bupropion when nicotine dependency was high (Fagerström score >7). The success rate was evaluated by intention to treat; point prevalence abstinence was measured 6 and 12 months post intervention by personal testimony, confirmed by means of CO-oximetry (value < 6ppm).\n The measure of effectiveness of the treatment for giving up smoking after both 6 and 12 months, showed that the motivational interviewing action was 5.2 times higher than anti-smoking advice (18.4 % compared to 3.4%; 95% confidence interval = 1.63 to 17.13).\n The results of our study show that motivational interviewing is more effective than brief advice for giving up smoking.", "Smoking cessation after myocardial infarction (MI) has been associated with a 50% reduction in mortality but in-hospital smoking cessation interventions are rarely part of routine clinical practice.\n One hundred cigarette smokers consecutively admitted during 1996 with MI were assigned to minimal care or to a hospital-based smoking cessation program. Intervention consisted of bedside cessation counseling followed by seven telephone calls over the 6 months following discharge. Primary outcomes were abstinence rates measured at 6 months and 1 year post-discharge.\n At follow-up, 43 and 34% of participants in minimal care and 67 and 55% of participants in intervention were abstinent at 6 and 12 months. respectively (P<0.05). Abstinence rates were calculated assuming that participants lost to attrition were smokers at follow-up. Intervention and self-efficacy were independent predictors of smoking status at follow-up. Low self-efficacy combined with no intervention resulted in a 93% relapse rate by 1 year (P<0.01).\n A hospital-based smoking cessation program consisting of inpatient counseling and telephone follow-up substantially increases smoking abstinence 1 year after discharge in patients post-MI. Patients with low self-efficacy are almost certain to relapse without intervention. Such smoking cessation programs should be part of the management of patients with MI.\n Copyright 2000 American Health Foundation and Academic Press.", "The purpose of this study was to evaluate the impact of a tobacco cessation intervention using motivational interviewing on smoking cessation rates during diabetes self-management training (DSMT).\n A randomized controlled trial was conducted with subjects recruited from an ongoing type 2 diabetes adult education program at a large diabetes center. A total of 114 subjects were randomized to intervention (n = 57; face-to-face motivational interviewing plus telephone counseling and offering of medication) or standard care (n = 57). Outcome measures included tobacco cessation rates, mean number of cigarettes smoked, A1C, weight, blood pressure, and lipids.\n Intensive intervention using motivational interviewing integrated into a standard DSMT program resulted in a trend toward greater abstinence at 3 months of follow-up in those receiving the intervention. However, this same trend was not observed at 6 months. The addition of this structured smoking cessation intervention did not negatively affect either diabetes education or other measures of diabetes management, including A1C values.\n Structured tobacco cessation efforts can be readily integrated into established diabetes education programs without a negative impact on diabetes care or delivery of diabetes education. However, an intervention of moderate intensity for smoking cessation was no more effective than usual care in assisting patients with tobacco cessation after 6-month follow-up. Whether a more intensive intervention, targeting patients expressing a readiness to discontinue tobacco use, and/or a longer duration or a more cumulative effect of treatment will be more effective must be evaluated.", "The purpose of this study was to evaluate a brief smoking cessation intervention for women 15 to 35 years of age attending Planned Parenthood clinics.\n Female smokers (n = 1154) were randomly assigned either to advice only or to a brief intervention that involved a 9-minute video, 12 to 15 minutes of behavioral counseling, clinician advice to quit, and follow-up telephone calls.\n Seventy-six percent of those eligible participated. Results revealed a clear, short-term intervention effect at the 6-week follow-up (7-day self-reported abstinence: 10.2% vs 6.9% for advice only, P < .05) and a more ambiguous effect at 6 months (30-day biochemically validated abstinence: 6.4% vs 3.8%, NS).\n This brief, clinic-based intervention appears to be effective in reaching and enhancing cessation among female smokers, a traditionally underserved population.", "Smokeless tobacco (ST) use has been associated with numerous negative health consequences, yet the prevalence of ST has increased dramatically since the 1970s. Young males in the military are at an elevated risk for ST use relative to the general population. Sixty active-duty male participants were identified as ST users during their annual preventive health screening and randomly assigned to minimal-contact intervention or usual care. Intervention participants were proactively contacted by phone and recruited, using a motivational interviewing style, for a cessation program consisting of a treatment manual, video, and two supportive phone calls from a cessation counselor. Sixty-five per cent (20/31) agreed to participate in the minimal-contact intervention. Three- and 6-month follow-up contacts found that the cessation rates reported by intervention participants were double those reported by participants receiving usual care (41% vs. 17% at 3 months, 37% vs. 19% at 6 months). These pilot study data suggest that proactive recruitment using a motivational interviewing approach to offer a treatment provides a good opportunity to reduce the use of ST in military settings.", "Current treatment guidelines recommend that all smokers be given motivational or action-oriented counseling, as is appropriate to their readiness to quit smoking. The present study assessed the acceptability and impact of a proactively delivered, motivationally tailored phone counseling program targeted to women with elevated risk for cervical cancer. Female smokers with a recent abnormal pap exam or a colposcopy were contacted and invited to participate, regardless of their interest in quitting smoking. Participants were randomly assigned to usual care (UC) or UC plus motivationally enhanced phone counseling (MEC). The intervention was well received: 79% of eligible women enrolled (n = 275), and 90% completed at least three of four calls. Participation did not vary by baseline motivation to quit. Compared with control subjects, counseling participants were more likely to seek additional treatment services and had a higher 7-day point-prevalence abstinence rate at 6 months (20% MEC vs. 12% UC, p<.05). MEC impact was sustained at 12 months, but abstinence increased among the UC group (18% MEC vs. 20% UC, p = ns). There was no difference in repeated point-prevalence abstinence at 6 and 12 months (11% MEC vs. 10% UC, p = ns). Outcomes were similar in a subgroup of 229 women who, at baseline, were interested in quitting in the next 6 months.", "This study examines the efficacy of a smoking cessation intervention on abstinence rates and motivation to quit smoking. Participants were adult smokers (N = 543) who presented to the emergency department with chest pain and who were admitted to an observation unit for 24-hour observation to rule out myocardial infarction. Participants were randomly assigned to either usual care or a tailored intervention employing motivational interviewing and telephone follow-up. All individuals choosing to quit were offered nicotine patch therapy. Follow-up assessments were conducted at 1, 3 and 6 months. Abstinence (7-day point prevalence) rates were significantly greater among participants receiving the tailored intervention compared with those given usual care (OR = 1.62, 95% CI [1.05-2.50]). The largest difference occurred at 1 month: 16.8% of usual care and 27.3% of the tailored intervention group were abstinent, with differences decreasing over time. One-third of participants who were quit at month 6 were late quitters whose initial abstinence began after the 1-month follow up. In addition to treatment assignment, psychosocial variables including motivation to quit, confidence, reduced temptation to smoke in response to negative affect, and the perception that their chest pain was related to their smoking, were significant predictors of cessation. Tailored interventions are effective in promoting initial quit attempts for emergency chest pain patients admitted to an observation unit. Additional intervention may be needed to assist late quitters and to prevent relapse.", "To test, in combination with the nicotine patch, the incremental efficacy of a maximal, tailored behavioral treatment over a minimal treatment for smoking cessation.\n Randomized clinical trial with 6-month follow-up.\n Five methadone maintenance treatment centers in Rhode Island.\n Three hundred and eighty-three methadone-maintained smokers.\n Participants were assigned randomly to nicotine patch (8-12 weeks) plus either (1) a baseline tailored brief motivational intervention, a quit date behavioral skills counseling session and a relapse prevention follow-up session (Max) or (2) brief advice using the National Cancer Institute's 4 As model (Min). An intent-to-treat analysis with those lost to follow-up assumed to smoke was used.\n Carbon monoxide (CO)-confirmed 7-day point smoking cessation prevalence at 3 and 6 months, and self-reported numbers of cigarettes smoked per day.\n Participants had a mean age of 40 years, were 53% male, 78% Caucasian, smoked 26.7 (+/- 12.2) cigarettes/day and had a mean methadone dose of 95.5 mg. At 3 months, 317 (83%) were re-interviewed; at 6 months, 312 (82%) were re-interviewed. The intent-to-treat, 7-day point prevalence estimate of cessation was 5.2% in the Max group and 4.7% in the Min group (P=0.81) at 6 months. In logistic models with treatment condition, age, gender, race, Fagerström Test for Nicotine Dependence and cigarettes per day as covariates, males were more likely to be abstinent at 3 months (OR 4.67; P=0.003) and 6 months (OR 4.01; P=0.015).\n A tailored behavioral intervention did not increase quit rates over patch and minimal treatment. Smoking cessation rates in methadone-maintained smokers are low, with men having greater success.", "Continued high rates of smoking among socioeconomically disadvantaged women lead to increases in children's health problems associated with exposure to tobacco smoke. The pediatric clinic is a \"teachable setting\" in which to provide advice and assistance to parents who smoke.\n To evaluate a smoking cessation intervention for women.\n Two-arm (usual care vs intervention) randomized trial.\n Pediatric clinics serving an ethnically diverse population of low-income families in the greater Seattle, Wash, area.\n During the clinic visit, women received a motivational message from the child's clinician, a guide to quitting smoking, and a 10-minute motivational interview with a nurse or study interventionist. Women received as many as 3 outreach telephone counseling calls from the clinic nurse or interventionist in the 3 months following the visit.\n Self-identified women smokers (n = 303) whose children received care at participating clinics.\n Self-reported abstinence from smoking 12 months after enrollment in the study, defined as not smoking, even a puff, during the 7 days prior to assessment.\n Response rates at 3 and 12 months were 80% and 81%. At both follow-ups, abstinence rates were twice as great in the intervention group as in the control group (7.7% vs 3.4% and 13.5% vs 6.9%, respectively). The 12-month difference was statistically significant.\n A pediatric clinic smoking cessation intervention has long-term effects in a socioeconomically disadvantaged sample of women smokers. The results encourage implementation of evidence-based clinical guidelines for smoking cessation in pediatric practice.", "Clinical guidelines for smoking cessation may not be sufficient for helping some subgroups of smokers quit. Incorporating smoking cessation into home-based medical care can proactively reach high-risk smokers who may not have access to (or spontaneously seek) smoking cessation.\n Home health care nurses (N = 98) were randomly assigned to deliver either Motivational Enhancement (ME; Motivational Interviewing + Carbon Monoxide Feedback) or Standard Care (AHCPR Guidelines for smoking cessation) to their patients. Seventy percent of patients were eligible and willing to participate (N = 273; 54% female, mean age = 57 years, 83% Caucasian, 41% < high school education). The study was conducted in Providence, RI, USA from 1998 to 2003.\n Biochemically verified continuous abstinence rates at the 12-month follow-up were 4.2% (SC) and 8.7% (ME) for intent to treat analyses, and 5.2% (SC) and 11.8% (ME) using all available cases (P > 0.05). ME reported more quit attempts and significantly greater reductions in the number of cigarettes smoked per day at all follow-ups through 12 months of post-treatment (all P values < 0.05).\n Use of an existing public health channel such as home health care to reach smokers who vary in their motivation to quit could have the potential for large public health impact.", "Hospitalization may be an opportune time to change smoking behavior because it requires smokers to abstain from tobacco at the same time that illness can motivate them to quit. A hospital-based intervention may promote smoking cessation after discharge.\n We tested the efficacy of a brief bedside smoking counseling program in a randomized controlled trial at Massachusetts General Hospital, Boston. The 650 adult smokers admitted to the medical and surgical services were randomly assigned to receive usual care or a hospital-based smoking intervention consisting of (1) a 15-minute bedside counseling session, (2) written self-help material, (3) a chart prompt reminding physicians to advise smoking cessation, and (4) up to 3 weekly counseling telephone calls after discharge. Smoking status was assessed 1 and 6 months after hospital discharge by self-report and validated at 6 months by measurement of saliva cotinine levels.\n One month after discharge, more intervention than control patients were not smoking (28.9% vs 18.9%; P=.003). The effect persisted after multiple logistic regression analyses adjusted for baseline group differences, length of stay, postdischarge smoking treatment, and hospital readmission (adjusted odds ratio, 2.19; 95% confidence interval, 1.34-3.57). At 6 months, the intervention and control groups did not differ in smoking cessation rate by self-report (17.3% vs 14.0%; P=.26) or biochemical validation (8.1% vs 8.7%; P=.72), although the program appeared to be effective among the 167 patients who had not previously tried to quit smoking (15.3% vs 3.7%; P=.01).\n A low-intensity, hospital-based smoking cessation program increased smoking cessation rates for 1 month after discharge but did not lead to long-term tobacco abstinence. A longer period of telephone contact after discharge might build on this initial success to produce permanent smoking cessation among hospitalized smokers." ]

[ "10224737", "3980816", "6477369", "11080605", "6841768", "4048081", "10447232", "9583339", "7608347", "971209", "11182214", "10023731", "8788323", "4056186", "5095076", "4730652", "7593872", "5490714", "730931", "6437150" ]

[ "Behavioral choice treatment promotes continuing weight loss: preliminary results of a cognitive-behavioral decision-based treatment for obesity.", "Behavior change, weight loss, and physiological improvements in type II diabetic patients.", "Intermittent low-calorie regimen and booster sessions in the treatment of obesity.", "Simultaneous nutritional cognitive--behavioural therapy in obese patients.", "Monetary contracts in weight control: effectiveness of group and individual contracts of varying size.", "Promoting weight control at the worksite: a pilot program of self-motivation using payroll-based incentives.", "Improved fibrinolysis by intense lifestyle intervention. A randomized trial in subjects with impaired glucose tolerance.", "Nondieting versus dieting treatment for overweight binge-eating women.", "Does interpersonal therapy help patients with binge eating disorder who fail to respond to cognitive-behavioral therapy?", "Individual differences in self-reinforcement style and performance in self- and therapist-controlled weight reduction programs.", "Randomised controlled trial evaluating the effectiveness of behavioural interventions to modify cardiovascular risk factors in men and women with impaired glucose tolerance: outcomes at 6 months.", "The impact of a shipboard weight control program.", "Food provision vs structured meal plans in the behavioral treatment of obesity.", "Ambulatory computer-assisted therapy for obesity: a new frontier for behavior therapy.", "A three-dimensional program for the treatment of obesity.", "Covert sensitization: conditioning or suggestion?", "Long-term effects of interventions for weight loss using food provision and monetary incentives.", "Effectiveness of group therapy based upon learning principles in the treatment of overweight women.", "Situational management, standard setting, and self-reward in a behavior modification weight loss program.", "Minimal interventions for weight control: a cost-effective alternative." ]

[ "Twenty-four obese women were randomly assigned to 1 of 2 group treatments: behavioral choice treatment (BCT) or traditional behavioral treatment (TBT). BCT uses decision theory to promote moderate behavior change that can be comfortably, and therefore permanently, maintained. Groups completed a moderate-intensity walking program and obtained feedback from computerized eating dairies. The TBT group evidenced greater weight loss at posttreatment. However, the TBT group also evidenced a trend to regain weight, whereas the BCT group continued a slow weight loss during follow-up. Exercise followed a similar pattern. Both groups decreased in restraint and increased in self-esteem.", "nan", "nan", "The most important problem in cognitive-behavioural therapies for obese patients is to initiate weight loss without reinforcing the eating-behavioural disorders. We propose to assess the cognitive-behavioural therapy in obese patients suffering from eating disorders with and without combining a nutritional approach based on fat information. The patients (n = 60) have followed a group treatment of 12 weekly cognitive-behavioural therapy sessions with or without a combined nutritional approach mainly focused on fat restriction. The scores for depression (P < 0.01), anxiety (P < 0.01) and eating disorders (P < 0.001) are significantly and similarly improved with both types of treatments. The mean weight loss is significant (P < 0.001) only after a combined nutritional cognitive-behavioural approach. The Eating Disorders Inventory (EDI) subgroup 'Drive for thinness' remains only in a combined therapy (ANOVA P < 0.01), which could explain the weight loss that only occurs in this group. Finally, the association between a cognitive-behavioural therapy and a nutritional learning process improves the anxiety and depression related to eating disorders as well as the weight loss.", "nan", "Thirty-six individuals participated in a worksite weight-loss program in which the central component was a self-motivation program of biweekly payroll deductions refunded contingent on meeting self-selected weight-loss goals. Half were assigned to early treatment and the remainder to a delayed treatment control group. Nine additional individuals also enrolled at the time of delayed treatment and were included in descriptive analyses of factors associated with weight loss. Results showed low program attrition over 6 months (6%) and mean weight losses (12.3 lb) that are competitive with those obtained in clinical settings. Although not different at baseline, participants in the delayed treatment group lost more than twice as much weight as those in the early treatment condition. This difference was interpreted as either a strong seasonal effect or a critical mass effect related to the proportion of employees at the worksite participating in the program. We conclude that self-motivation programs for health behavior change using the payroll system as an organization framework offer a promising new methodology for promoting healthful behaviors in work settings.", "To assess the effects of lifestyle intervention on cardiovascular risk factors in general and especially on fibrinolysis.\n Randomized clinical study.\n A total of 186 subjects with impaired glucose tolerance and obesity.\n The intervention programme included a low-fat, high-fibre diet and regular physical exercise. Half of the participants (n = 93) took part in a one-month learning and training session using different behavioural modification techniques and conducted in a full-board wellness centre (intense intervention group). The other half (n = 93) was randomized a one-hour counselling session with a specially trained nurse (usual care group). Follow-up was carried out after 12 months.\n Body weight, oxygen consumption, plasminogen activator inhibitor type 1 (PAI-1) activity, tissue plasminogen activator (tPA) antigen, fibrinogen and fasting plasma insulin measured at the start of the programme and at follow-up after 1 year.\n The intense intervention group had a mean weight decline by 1 year of 5.4 kg compared to 0.5 kg in the usual care group. Oxygen consumption in the intense group increased 10% vs. a 1% decline in the usual care group. In the intense group, PAI-1 activity decreased 31% (-10.1 U mL(-1)), which was significantly more than in the usual care group (12%; -3.0 U mL(-1)). The corresponding reductions in tPA antigen were 14% (-1.65 microg L(-1)) and 6% (-0.69 microg L(-1)).\n The present randomized study shows that an intense lifestyle programme has sustained beneficial effects on fibrinolysis.", "This study evaluated the effectiveness of nondieting versus dieting treatments for overweight, binge-eating women. Participants (N = 219) were randomly assigned to 1 of 3 groups: diet treatment (DT), nondiet treatment (NDT), or wait-list control (WLC). DT received a balanced-deficit diet reinforced with behavioral strategies. NDT received therapy designed to help participants break out of their dieting cycles. Treatment in both conditions was administered in weekly groups for 6 months, followed by 26 biweekly maintenance meetings, for a total of 18 months of contact. At 6 months posttreatment, DT lost 0.6 kg while NDT gained 1.3 kg. Both treatment groups reduced their Binge Eating Scale scores significantly more than WLC. At 18-month follow-up, both treatment groups experienced weight gain but maintained similar reductions in binge eating. Results indicate that neither intervention was successful in producing short- or long-term weight loss. Therapist biases, which may have affected treatment integrity, and other methodological issues are discussed in relation to the small weight losses achieved.", "The aim of this quasi-experimental study was to examine the effectiveness of group interpersonal therapy (IPT) in treating overweight patients with binge eating disorder who did not stop binge eating after 12 weeks of group cognitive-behavioral therapy (CBT). Participants in this study were randomly allocated to either group CBT or to an assessment-only control group. After 12 weeks of treatment with CBT, 55% of participants met criteria for improvement and began 12 weeks of weight loss therapy, whereas the nonresponders began 12 weeks of group IPT. Over the 24-week period, participants who received treatment reduced binge eating and weight significantly more than the waiting-list control group. However, IPT led to no further improvement for those who did not improve with CBT. Predictors of poor outcome were early onset of, and more severe, binge eating.", "nan", "To evaluate the efficacy of interventions to promote a healthy diet and physical activity in people with impaired glucose tolerance (IGT).\n A randomised controlled trial in Newcastle upon Tyne, UK, 1995-98. Participants included 67 adults (38 men; 29 women) aged 24-75 years with IGT. The intervention consisted of regular diet and physical activity counselling based on the stages of change model. Main outcome measures were changes between baseline and 6 months in nutrient intake; physical activity; anthropometric and physiological measurements including serum lipids; glucose tolerance; insulin sensitivity.\n The difference in change in total fat consumption was significant between intervention and control groups (difference -21.8 (95% confidence interval (CI) -37.8 to -5.8) g/day, P=0.008). A significantly larger proportion of intervention participants reported taking up vigorous activity than controls (difference 30.1, (95% CI 4.3--52.7)%, P=0.021). The change in body mass index was significantly different between groups (difference -0.95 (95% CI -1.5 to -0.4) kg/m(2), P=0.001). There was no significant difference in change in mean 2-h plasma glucose between groups (difference -0.19 (95% CI -1.1 to 0.71) mmol/l, NS) or in serum cholesterol (difference 0.02 (95% CI -0.26 to 0.31) mmol/l, NS). The difference in change in fasting serum insulin between groups was significant (difference -3.4 (95% CI -5.8 to -1.1) mU/l, P=0.005).\n After 6 months of intensive lifestyle intervention in participants with IGT, there were changes in diet and physical activity, some cardiovascular risk factors and insulin sensitivity, but not glucose tolerance. Further follow-up is in progress to investigate whether these changes are sustained or augmented over 2 years.", "The specific aim was to determine whether a multifaceted approach to weight loss and physical readiness could be implemented onboard a deployed combatant ship of the U.S. Navy.\n Thirty-nine men (31+/-6 years old, mean+/-standard deviation) assigned to the USS ENTERPRISE (CVN 65) during a 6-month Mediterranean deployment who had failed their previous Physical Readiness Test due to excessive body weight (108+/-11 kg overweight) were randomly assigned to nutrition, cognitive-behavioral obesity treatment plus exercise or to the Navy's usual treatment (control), which is exercise alone.\n Outcomes for the treatment group were significantly better than the controls, with 8.6+/-5.0 vs. 5.0+/-4.1 kg weight loss, 8% vs. 5% reduction in original body weight, and body fat loss of 7% vs. 5%. Triglycerides declined significantly greater in the treatment group than the controls (145 mg/dL to 109 mg/dL vs. 146 mg/dL to 145 mg/dL, p<0.05), whereas depression and eating behaviors significantly improved among treated men. Problematic environmental factors were the limited variety of heart healthy foods in the galley, short meal breaks, and long mess hall lines that led to eating snacks from vending machines and frequent port calls.\n Although greater weight loss than would be expected of a Navy usual care group diluted the treatment effect, the treated men still fared significantly better. The physical readiness implication of this research has the potential to impact Navy health promotion programs and policy, the health and well-being of its personnel, and the Navy's ability to meet mission requirements.", "Providing overweight patients with the food they should eat has been shown to significantly improve weight loss in a behavioral treatment program. The objective of this study was to examine the contribution of three components of food provision to these positive effects: the specific meal plans indicating what foods should be eaten at each meal; the food itself; and the fact that the food was provided free.\n 163 overweight women.\n Randomized, controlled study with subjects assigned to one of four conditions: (1) a standard behavioral treatment program (SBT) with weekly meetings for six months; (2) SBT plus structured meal plans and grocery lists; (3) SBT plus meal plans plus food provision, with subjects sharing the cost; or (4) SBT plus meal plans plus free food provision.\n Subjects in Group 1 lost significantly less weight than subjects in Groups 2-4 at the end of the six month program (-8.0 kg vs -12.0, -11.7 and -11.4 kg respectively) and at follow-up one year later (-3.3 kg vs -6.9, -7.5 and -6.6 kg respectively). No significant differences were seen in weight loss between Groups 2-4, suggesting that the component of food provision that is responsible for its success is the provision of highly structured meal plans and grocery lists. Subjects receiving meal plans were more likely to exhibit an eating pattern of three meals/day, had more definite plans regarding what to eat and reported more favorable changes in foods stored in their homes and in perceived barriers to weight loss.\n Providing structured meal plans and grocery lists improves outcome in a behavioral weight control program; no further benefit is seen by actually giving food to patients.", "nan", "nan", "nan", "One hundred seventy-seven men and women who had participated in an 18-month trial of behavioral interventions involving food provision and financial incentives were examined 12 months later. Food provision, but not financial incentives, led to better weight loss than standard behavioral treatment during the 18-month trial, but over 12 additional months of no-treatment follow-up, all treated groups gained weight, maintained only slightly better weight losses than a no-treatment control group, and did not differ from each other. Weight loss success during both active treatment and maintenance was associated with increase in exercise, decrease in percentage of energy from fat, increase in nutrition knowledge, and decrease in perceived barriers to adherence. Obesity treatment research should focus on developing better ways to maintain changes in the diet and exercise behaviors needed for sustained weight loss.", "nan", "nan", "Two studies were conducted to evaluate simpler, less intensive interventions for weight control which presumably would be more cost-effective and efficient than a \"full-length\" behavioral treatment program. In Study 1, participants in a minimal intervention (MI1) program who attended no regularly scheduled meetings and initially only received three simple verbal instructions about how to lose weight, lost an average of 11.1 lb. by 7-month follow-up. Subjects in three variations of a shortened, less intensive, 6-week behavioral weight loss program lost 7.8, 6.5 and 6.3 lb. but did not significantly differ from MI1 subjects in the amount of weight lost. In Study 2, MI2 subjects lost 5.5 lb. compared to subjects in two variations of a full-length program who lost 8.1 and 11.1 lb. by 6-month follow-up. Again, none of the groups significantly differed from each other in the amount lost. It was concluded that a minimal intervention program seems to produce weight loss and to be a cost-effective and efficient method for some subjects. The difference between the two minimal intervention programs may be related to the payment of a monetary deposit; a model for future research was presented to investigate simpler, less intensive interventions in combination with more complex ones in a \"stepped-care\" fashion." ]

[ "17684661", "8215728", "10753321", "11771024", "3355041", "16314604" ]

[ "Tinnitus treatment with Trazodone.", "A randomized trial of nortriptyline for severe chronic tinnitus. Effects on depression, disability, and tinnitus symptoms.", "Idiopathic Subjective Tinnitus Treated by Amitriptyline Hydrochloride/Biofeedback.", "Efficacy of amitriptyline in the treatment of subjective tinnitus.", "The tricyclic trimipramine in the treatment of subjective tinnitus.", "Randomized placebo-controlled trial of a selective serotonin reuptake inhibitor in the treatment of nondepressed tinnitus subjects." ]

[ "Tinnitus is a common symptom, defined as a sound perception in absence of a sound stimulus.\n Evaluate if Trazodone, an antidepressant drug, which modulates serotonin at central neuronal pathways, is effective in controlling tinnitus.\n Prospective, double blind, randomized, placebo-controlled.\n Study performed with patients presenting tinnitus. 85 patients were analyzed between February and June of 2005. 43 received trazodone and 42 placebo, for 60 days. The clinical criteria of analysis were tinnitus intensity, discomfort and life quality impact by tinnitus, using an analogue scale varying between 0 and 10, scored by patients before and after drug or placebo use.\n There was a significant improvement in intensity, discomfort and life quality in both groups after treatment; however, there was no significant difference between the drug and placebo groups. Patients with age equal or over 60 years presented better results after treatment.\n Trazodone was not efficient in controlling tinnitus in the patients evaluated under the doses utilized.", "To determine whether the antidepressant, nortriptyline, is effective for treatment of depression, tinnitus-related disability, and tinnitus symptoms in patients with severe chronic tinnitus.\n A 12-week, double-blind, randomized controlled trial.\n A university otolaryngology clinic.\n Ninety-two subjects with severe chronic tinnitus: 38 with current major depression and 54 with depressive symptoms and significant tinnitus-related disability.\n Nortriptyline (maintained at 50 to 150 mg/mL for 6 weeks) or placebo.\n Hamilton Depression Rating Scale, Tinnitus Disability Measures, and Audiometric Measures.\n Nortriptyline was superior to placebo by multivariate analysis of covariance for depression (10.6 vs 14.3 final Hamilton Depression score), for tinnitus-related disability (1.8 vs 2.4 final MPI Tinnitus Interference), and tinnitus loudness (13.6 vs 20.0 dB final loudness match [in worst ear at tinnitus frequency]). When major depression and depressive symptoms groups were considered separately, nortriptyline was superior to placebo on these same measures but differences did not achieve statistical significance.\n The antidepressant nortriptyline decreases depression, functional disability, and tinnitus loudness associated with severe chronic tinnitus. What appears to be irreversible disability of otologic origin may, in part, be reversible disability of psychiatric origin.", "The efficiency of two treatment modalities for subjective/idiopathic tinnitus (SIT): biofeedback (BF) and amitriptyline hydrochloride (AT) was investigated in 225 randomly selected subjects. Findings show that after 10 weeks of treatment in the BF group, 43.5% of the patients reported an improvement of tinnitus during activity. In the AT group, 27.5% of patients reported subjective improvement of tinnitus at rest although only 15.8% of the AT patients reported improvement during activity. Biofeedback during rest had a significantly better effect on tinnitus disturbance than AT. No objective diminishment of tinnitus loudness was found as a result of any of the treatment modalities. We believe that BF can help tinnitus patients especially during periods of rest and we also suggest trying tricyclic antidepressant drugs such as AT for treatment of tinnitus patients, in small doses, however, to minimize the side effects of this drug. Subjective tinnitus (ST) is one of the most common and yet most unclear of otologic symptoms.(1-4) ST can accompany any type of hearing loss including both sensorineural as well as conductive hearing loss, and may originate from any part of the auditory pathway.(1,5) Treatment of ST must be primarily directed to the basic illness diagnosed after a thorough general ear-nose-throat and neurologic evaluation.(6) Severity of ST is evaluated both objectively, by determining the pitch and intensity of the tinnitus,(7) and subjectively as described by the patient. Because of the relatively high incidence of ST and in some patients, the severe personal reaction to it, many different treatments have been suggested, but generally only small to moderate success has been achieved in reducing tinnitus and its consequences, if any at all.(8) In this study we examined the effect of two treatment modalities: amitriptyline hydro-chloride and biofeedback.", "We investigated the effect of amitriptyline, a tricyclic antidepressant, on patients with subjective tinnitus. The study group consisted of 37 adult patients admitted to the Ear, Nose, and Throat and Audiology Department of Hacettepe University. The amitriptyline group consisted of 20 patients and the placebo group consisted of 17 patients. All of the patients were evaluated using a questionnaire, audiologic evaluation, high-frequency audiometry, impedancemetric tests, auditory brainstem response, tinnitus frequency, and loudness matching assessed by audiometric methods at the beginning and end of the study. The patients in the amitriptyline group received 50 mg/day amitriptyline in the first week and 100 mg/day for the following 5 weeks. In the placebo group, the patients received tablets consisting of lactose starch for 6 weeks, with a dosage of 1 tablet/day. The subjective complaints of the patients in the amitriptyline group decreased, and the \"present\" symptoms resulted in fewer complaints. The severity of tinnitus decreased in the amitriptyline group by means of subjective and audiometric methods. In the placebo group, no significant change was observed. The success of treatment was 95% in the amitriptyline group and 12% in the placebo group. Amitriptyline therapy was concluded to be effective.", "We examined 26 consecutive patients with subjective tinnitus. All subjects were treated with the tricyclic antidepressant trimipramine in a double-blind study, each subject acting as his own control. All subjects were evaluated with pure tone audiometry, site of lesion testing, and auditory brain stem evoked response. The tinnitus assessment consisted of frequency and intensity matching, the determination of masking levels, and a subjective evaluation of severity. Plasma levels of trimipramine were monitored at regular intervals, and the Zung and Millon inventories were administered at the beginning and end of each study period. Nineteen subjects completed the study. Within the trimipramine group, one reported complete disappearance of his tinnitus, eight reported improvement, three no change, and seven that tinnitus was worse. Within the placebo group, eight reported improvement, seven no change, and four that tinnitus was worse. The natural history of tinnitus is such that what has been observed may reflect the evolution of the disease itself, rather than the effect of treatment. We feel that while tricyclics may not have been shown to be effective, the placebo effect played a significant role in the results obtained.", "To assess the efficacy of a selective serotonin reuptake inhibitor (paroxetine) for relief of tinnitus.\n One hundred twenty tinnitus sufferers participated in a randomized double-blind placebo-controlled trial. Paroxetine or placebo was increased to a maximally tolerated dose (up to 50 mg/day), and patients were treated for a total of 31 days at the maximal dose.\n Patients with chronic tinnitus were recruited from our university-based specialty clinic by referral from otolaryngologists and audiologists in the local community and by advertisement. Patients with psychotic or substance use disorders or suicidal ideation were excluded, as were those using psychoactive medications (this resulted in only 1 subject with major depression in the study) or any other medications that interact with paroxetine and those with inability to hear at one's tinnitus sensation level. Fifty-eight percent of patients were male, 92% were Caucasian, and the average age was 57.\n Tinnitus matching, the Tinnitus Handicap Questionnaire, the question: How severe (bothered, aggravating) is your tinnitus? Quality of Well-Being and other psychological questionnaires.\n Paroxetine was not statistically superior to placebo on the following tinnitus measures (tinnitus matching, 5- or 10-db drop, Tinnitus Handicap Questionnaire, quality of well-being measures, how severe, how bothered, positive change). There was a significant improvement in the single item question, How aggravating is your tinnitus? for those in the paroxetine group compared with the placebo group.\n These results suggest that the majority of individuals in this study did not benefit from paroxetine in a consistent fashion. Further work remains to be done to determine if subgroups of patients (e.g., those who tolerate higher doses, those who are depressed) may benefit." ]

[ "14685931", "12118641", "12366485", "16253255", "18231884", "15673989", "19278378", "12792557", "17261096", "17342250", "20822474" ]

[ "Effects of LI4 and BL 67 acupressure on labor pain and uterine contractions in the first stage of labor.", "Acupuncture treatment during labour--a randomised controlled trial.", "Acupuncture in the management of pain in labor.", "Effect of acupuncture on labor.", "Acupuncture versus subcutaneous injections of sterile water as treatment for labour pain.", "Effects of SP6 acupressure on labor pain and length of delivery time in women during labor.", "Acupuncture as pain relief during delivery: a randomized controlled trial.", "Acupuncture during labor can reduce the use of meperidine: a controlled clinical study.", "The effects of acupuncture during labour on nulliparous women: a randomised controlled trial.", "Electro-acupuncture in relieving labor pain.", "Acupressure to reduce labor pain: a randomized controlled trial." ]

[ "Acupressure is said to promote the circulation of blood and qi, the harmony of yin and yang, and the secretion of neurotransmitters, thus maintaining the normal functions of the human body and providing comfort. However, there has been little research-based evidence to support the positive effects of acupressure in the area of obstetric nursing. The purpose of this study is to determine the effect of LI4 and BL67 acupressure on labor pain and uterine contractions during the first stage of labor. An experimental study with a pretest and posttest control group design was utilized. A total of 127 parturient women were randomly assigned to three groups. Each group received only one of the following treatments, LI4 and BL67 acupressure, light skin stroking, or no treatment/conversation only. Data collected from the VAS and external fetal monitoring strips were used for analysis. Findings indicated that there was a significant difference in decreased labor pain during the active phase of the first stage of labor among the three groups. There was no significant difference in effectiveness of uterine contractions during the first stage of labor among the three groups. Results of the study confirmed the effect of LI4 and BL67 acupressure in lessening labor pain during the active phase of the first stage of labor. There were no verified effects on uterine contractions.", "To investigate acupuncture treatment during labour with regard to pain intensity, degree of relaxation and outcome of the delivery.\n Randomised controlled trial.\n Delivery ward at a tertiary care centre hospital in Sweden.\n Ninety parturients who delivered during the period April 12, 1999 and June 4, 2000.\n Forty-six parturients were randomised to receive acupuncture treatment during labour as a compliment, or an alternative, to conventional analgesia.\n Assessments of pain intensity and degree of relaxation during labour, together with evaluation of delivery outcome.\n Acupuncture treatment during labour significantly reduced the need of epidural analgesia (12% vs 22%, relative risk [RR] 0.52, 95% confidence interval [CI] 0.30 to 0.92). Parturients who received acupuncture assessed a significantly better degree of relaxation compared with the control group (mean difference -0.93, 95% CI -1.66 to -0.20). No negative effects of acupuncture given during labour were found in relation to delivery outcome.\n The results suggest that acupuncture could be a good alternative or complement to those parturients who seek an alternative to pharmacological analgesia in childbirth. Further trials with a larger number of patients are required to clarify if the main effect of acupuncture during labour is analgesic or relaxing.", "To assess if acupuncture could be a reasonable option for pain relief in labor and to look at possible effects of acupuncture on the progress of labor.\n In a controlled, single blind study, 210 healthy parturients in spontaneous, active labor at term were randomly assigned to receive either real acupuncture or false acupuncture. Visual analog scale assessments were used to evaluate subjective effect on pain. The objective parameter of outcome was the need for analgesic medication in each group.\n There were significantly lower mean pain scores and significantly less need for pharmacological analgesia in the study group compared with the control group. The women given real acupuncture spent less time in active labor and needed less augmentation than the control group.\n The results indicate that acupuncture reduces the experience of pain in labor. A secondary outcome of acupuncture was a shorter delivery time, which mainly, if not exclusively, can be explained by the reduced need for epidural analgesia. Acupuncture may be useful for parturients who wish a nonpharmacological analgesia without side-effects. For others it could be the analgesic method of choice, with pharmacological analgesics as supplements.", "nan", "Two methods for pain relief and relaxation during labour are sterile water injections and acupuncture. In several studies, sterile water injections have been shown to provide good pain relief, particularly for low back pain during labour. The acupuncture studies for pain relief during labour are not as concordant. Therefore, the aim of this study was to explore if there were any differences between acupuncture and sterile water injections regarding pain relief and relaxation during labour.\n A randomised controlled trial. Some 128 pregnant women at term were randomly assigned to receive acupuncture (n=62) or sterile water injections (n=66). The primary endpoint was to compare the differences between pre-treatment pain levels and maximum pain in the 2 groups.\n The main results of this study were that sterile water injections yielded greater pain relief (p<0.001) during childbirth compared to acupuncture. The secondary outcome showed that women in the sterile water group had a higher degree of relaxation (p<0.001) compared to the acupuncture group. The women's own assessment of the effects also favoured sterile water injections (p<0.001). There were no significant differences regarding requirements for additional pain relief after treatment between the 2 groups.\n Women given sterile water injection experience less labour pain compared to women given acupuncture.", "The purpose of this study was to evaluate the effects of SP6 acupressure on labor pain and delivery time in women in labor.\n Randomized clinical trial.\n Delivery room in a university hospital.\n Seventy-five (75) women in labor were randomly assigned to either the SP6 acupressure (n = 36) or SP6 touch control (n = 39) group. The participants were matched according to parity, cervical dilation, labor stage, rupture of amniotic membrane, and husband's presence during labor. There were no additional oxytocin augmentation or administration of analgesics during the study period.\n The 30-minute acupressure or touch on SP6 acupoint was performed.\n Labor pain was measured four times using a structured questionnaire, a subjective labor pain scale (visual-analogue scale [VAS]): before intervention, immediately after the intervention, and 30 and 60 minutes after the intervention. Length of delivery time was calculated in two stages: from 3 cm cervical dilation to full cervical dilatation, and full cervical dilatation to the delivery.\n There were significant differences between the groups in subjective labor pain scores at all time points following the intervention: immediately after the intervention (p = 0.012); 30 minutes after the intervention (p = 0.021); and 60 minutes after the intervention (p = 0.012). The total labor time (3 cm dilatation to delivery) was significantly shorter in the SP6 acupressure intervention group than in the control group (p = 0.006).\n These findings showed that SP6 acupressure was effective for decreasing labor pain and shortening the length of delivery time. SP6 acupressure can be an effective nursing management for women in labor.", "Many women need some kind of analgesic treatment to relieve pain during childbirth. The objective of our study was to compare the effect of acupuncture with transcutaneous electric nerve stimulation (TENS) and traditional analgesics for pain relief and relaxation during delivery with respect to pain intensity, birth experience, and obstetric outcome.\n A randomized controlled trial was conducted with 607 healthy women in labor at term who received acupuncture, TENS, or traditional analgesics. Primary outcomes were the need for pharmacological and invasive methods, level of pain assessed by a visual analogue scale, birth experience and satisfaction with delivery, and pain relief evaluated at 2 months postpartum. Secondary obstetric outcomes were duration of labor, use of oxytocin, mode of delivery, postpartum hemorrhage, Apgar score, and umbilical cord pH value. Analysis complied with the intention-to-treat principle.\n Use of pharmacological and invasive methods was significantly lower in the acupuncture group (acupuncture vs traditional, p < 0.001; acupuncture vs TENS, p = 0.031). Pain scores were comparable. Acupuncture did not influence the duration of labor or the use of oxytocin. Mean Apgar score at 5 minutes and umbilical cord pH value were significantly higher among infants in the acupuncture group compared with infants in the other groups.\n Acupuncture reduced the need for pharmacological and invasive methods during delivery. Acupuncture is a good supplement to existing pain relief methods.", "To evaluate the effectiveness of acupuncture as an analgesic during labor.\n A randomized, unblinded, controlled study.\n A labor ward in a University Hospital.\n Parturients at term.\n One group received acupuncture (N = 106); another did not (N = 92). A second control group (N = 92), drawn from the labor ward protocol, consisted of patients who met the eligibility criteria for the study and were matched to the \"no acupuncture\" group by parity, but who had not been offered the opportunity to take part. Outcome measure \"effectiveness of acupuncture\" was measured by the requirement for use of meperidine.\n Meperidine was given to 11% of the acupuncture group, 37% of the no acupuncture group (P < 0.0001), and 29% of the control group. The use of other analgesics was also lower in the acupuncture group. Patient satisfaction was high: 89 of 103 patients asked said they would want acupuncture during another labor.\n Acupuncture during labor reduced the requirement for other painkillers and has high patient satisfaction in this randomized, unblinded, controlled study.", "Acupuncture is as an ancient system of diagnosis and treatment. It is regarded as a complementary tool for pain management.\n To assess the effects of acupuncture on nulliparous women during labour with respect to pain, labour duration and maternal acceptability.\n One hundred and forty-four healthy nulliparous women in active phase were randomised into the study and control group, receiving real and minimal acupuncture, respectively. Visual analogue scale was used to assess pain. Objectives were to evaluate acupuncture effect on pain and labour duration and patients' willingness to receive acupuncture for subsequent pregnancies.\n Visual analogue scale pain score in the study group was lower after two hours. Active phase duration and the oxytocin units administered were lower in the study group. Study group patients had greater willingness to receive acupuncture again. No adverse effects were detected.\n Acupuncture could reduce pain experience, active phase duration and oxytocin units. Patients were satisfied and no adverse effects were noted.", "To study the efficacy of electro-acupuncture for the relief of labor pain, and to build a better understanding of how electro-acupuncture might influence the neuroendocrine system, 36 primiparas were randomly divided into an electro-acupuncture group and a control group. Assessments of pain intensity and degree of relaxation during labor were analyzed. The differences between the electro-acupuncture group and the control group on the concentration of beta-endorphin (beta-EP) and 5-hydroxytryptamine (5-HT) in the peripheral blood were compared. The electro-acupuncture group was found to exhibit a lower pain intensity and a better degree of relaxation than the control group (p = 0.018; p = 0.031). There existed a significant difference in the concentration of beta-EP and 5-HT in the peripheral blood between the two groups at the end of the first stage (p = 0.037; p = 0.030). Electro-acupuncture was found to be an effective alternative or complementary therapy in the relief of pain during labor. The benefit of electro-acupuncture for relieving labor pain may be based on the mechanism of producing a synergism of the central nervous system (CNS) with a direct impact on the uterus through increasing the release of beta-EP and 5-HT into the peripheral blood.", "To evaluate the effect of acupressure administered during the active phase of labor on nulliparous women's ratings of labor pain.\n Randomized controlled trial.\n Public hospital in India.\n Seventy-one women randomized to receive acupressure at acupuncture point spleen 6 (SP6) on both legs during contractions over a 30-minute period (acupressure group), 71 women to receive light touch at SP6 on both legs during the same period of time (touch group) and 70 women to receive standard care (standard care group).\n Experience of in-labor pain was assessed by visual analog scale at baseline before treatment, immediately after treatment, and at 30, 60 and 120 minutes after treatment.\n Labor pain intensity at different time intervals after treatment compared with before treatment.\n A reduction of in-labor pain was found in the acupressure group and was most noticeable immediately after treatment (acupressure group vs. standard care group p < 0.001; acupressure group vs. touch group p < 0.001).\n Acupressure seems to reduce pain during the active phase of labor in nulliparous women giving birth in a context in which social support and epidural analgesia are not available. However, the treatment effect is small which suggests that acupressure may be most effective during the initial phase of labor." ]

[ "18851769", "17197587", "19858812", "11064229", "10675118", "20235415", "20219315", "12546286", "17693668", "16088014", "10610626", "18164324", "11157288", "20478753", "17341235" ]

[ "Use of a time series design to test effectiveness of a theory-based intervention targeting adherence of health professionals to a clinical guideline.", "Effects of teamwork training on adverse outcomes and process of care in labor and delivery: a randomized controlled trial.", "Improving chronic care of type 2 diabetes using teams of interprofessional learners.", "Identification and management of domestic violence: a randomized trial.", "Effects of a clinical-practice guideline and practice-based education on detection and outcome of depression in primary care: Hampshire Depression Project randomised controlled trial.", "Does teamwork improve performance in the operating room? A multilevel evaluation.", "A randomized controlled trial of communication training with primary care providers to improve patient-centeredness and health risk communication.", "Error reduction and performance improvement in the emergency department through formal teamwork training: evaluation results of the MedTeams project.", "Effect of crew resource management on diabetes care and patient outcomes in an inner-city primary care clinic.", "Use of a consumer-led intervention to improve provider competencies.", "Effect of clinician communication skills training on patient satisfaction. A randomized, controlled trial.", "Team training and stroke rehabilitation outcomes: a cluster randomized trial.", "An evaluation of a system-change training model to improve emergency department response to battered women.", "Using collaborative learning to improve diabetes care and outcomes: the VIDA project.", "Implementation and evaluation of a nursing home fall management program." ]

[ "The aim of this study was to test the effectiveness of a theory of planned behaviour intervention to increase adherence of community mental health professionals to a national suicide prevention guideline.\n Routinely collected audit adherence data from an intervention and control site were collected and analysed using time series analysis to test whether the intervention significantly increased adherence. The effects of a local and national event on adherence were also examined.\n A Theory of Planned Behaviour (TPB) questionnaire, developed from interview findings, was administered to the health professionals. Subjective norms were found to be the most significant predictor of intention to adhere to the guideline, and were targeted with an interactive educational intervention. Time series analysis applied to routinely collected audit adherence data was used to test intervention effectiveness.\n The TPB accounted for 58% of the variance in intention to adhere, with subjective norms the only significant predictor. The intervention did not significantly increase adherence; however, the national and local events were found to have significantly increased adherence.\n The TPB was a useful framework for exploring barriers to adherence; however, this did not translate into an effective intervention. Future research should seek collaboration with local experts, and use this information in combination with the TPB, to develop interventions. Collaborative research with experts in pedagogy may also help to develop more effective interventions, particularly education-based interventions that require adult learning.", "To evaluate the effect of teamwork training on the occurrence of adverse outcomes and process of care in labor and delivery.\n A cluster-randomized controlled trial was conducted at seven intervention and eight control hospitals. The intervention was a standardized teamwork training curriculum based on crew resource management that emphasized communication and team structure. The primary outcome was the proportion of deliveries at 20 weeks or more of gestation in which one or more adverse maternal or neonatal outcomes or both occurred (Adverse Outcome Index). Additional outcomes included 11 clinical process measures.\n A total of 1,307 personnel were trained and 28,536 deliveries analyzed. At baseline, there were no differences in demographic or delivery characteristics between the groups. The mean Adverse Outcome Index prevalence was similar in the control and intervention groups, both at baseline and after implementation of teamwork training (9.4% versus 9.0% and 7.2% versus 8.3%, respectively). The intracluster correlation coefficient was 0.015, with a resultant wide confidence interval for the difference in mean Adverse Outcome Index between groups (-5.6% to 3.2%). One process measure, the time from the decision to perform an immediate cesarean delivery to the incision, differed significantly after team training (33.3 minutes versus 21.2 minutes, P=.03).\n Training, as was conducted and implemented, did not transfer to a detectable impact in this study. The Adverse Outcome Index could be an important tool for comparing obstetric outcomes within and between institutions to help guide quality improvement.\n (www.ClinicalTrials.gov), NCT00381056\n I.", "To improve the care and outcomes of adult patients with type 2 diabetes by teaching interprofessional teams of learners the principles and practices of the Improving Chronic Illness Care Model.\n The study population consisted of 384 adult patients with type 2 diabetes. The study design was a nonrandomized, parallel-group, clinical trial conducted during 18 months in the University of California, San Francisco internal medicine clinics. Interprofessional team care provided by primary care internal medicine residents, nurse practitioner students, and pharmacy students was compared with usual care by internal medicine residents only. Processes of care, clinical status, and health utilization were measured in both patient groups. Learner outcomes also were assessed and compared.\n At study completion, intervention patients more frequently received assessments of glycosolated hemoglobin (79% versus 67%; P=.01), LDL-C (69% versus 55%; P=.009), blood pressure (86% versus 79%; P=.08), microalbuminuria (40% versus 30%; P=.05), smoking status assessment (43% versus 31%; P=.02), and foot exams (38% versus 20%; P=.0005). Intervention patients had more planned general medicine visits (7.9+/-6.2 versus 6.2+/-5.7; P=.006) than did control patients. Interprofessional learners rated themselves significantly higher on measures of accomplishment, preparation, and success for chronic care than did the usual care learners.\n Interprofessional team care by learners was effective in improving quality of care for adult patients with diabetes treated in general medicine clinics. The chronic illness framework resulted in more appropriate health care utilization.", "Diagnosis of domestic violence (DV) in primary care is low compared to its prevalence. Care for patients is deficient. Over a 1-year period, we tested the effectiveness of an intensive intervention to improve asking about DV, case finding, and management in primary care. The intervention included skill training for providers, environmental orchestration (posters in clinical areas, DV questions on health questionnaires), and measurement and feedback.\n We conducted a group-randomized controlled trial in five primary care clinics of a large health maintenance organization (HMO). Outcomes were assessed at baseline and follow-up by survey, medical record review, and qualitative means.\n Improved provider self-efficacy, decreased fear of offense and safety concerns, and increased perceived asking about DV were documented at 9 months, and also at 21 months (except for perceived asking) after intervention initiation. Documented asking about DV was increased by 14.3% with a 3.9-fold relative increase at 9 months in intervention clinics compared to controls. Case finding increased 1.3-fold (95%, confidence interval 0.67-2.7).\n The intervention improved documented asking about DV in practice up to 9 months later. This was mainly because of the routine use of health questionnaires containing DV questions at physical examination visits and the placement of DV posters in clinical areas. A small increase in case finding also resulted. System changes appear to be a cost-effective method to increase DV asking and identification.", "Depression is a major individual and public-health burden throughout the world and is managed mainly in primary care. The most effective strategy to reduce this burden has been believed to be education of primary-care practitioners. We tested this assumption by assessing the effectiveness of an educational programme based on a clinical-practice guideline in improving the recognition and outcome of primary-care depression.\n We carried out a randomised controlled trial in a representative sample of 60 primary-care practices (26% of the total) in an English health district. Education was delivered to practice teams and quality tested by feedback from participants and expert raters. The primary endpoints were recognition of depression, defined by the hospital anxiety and depression (HAD) scale, and clinical improvement. Analysis was by intention to treat.\n The education was well received by participants, 80% of whom thought it would change their management of patients with depression. 21409 patients were screened, of whom 4192 were classified as depressed by the HAD scale. The sensitivity of physicians to depressive symptoms was 39% in the intervention group and 36% in the control group after education (odds ratio 1.2 [95% CI 0.88-1.61]). The outcome of depressed patients as a whole at 6 weeks or 6 months after the assessment did not significantly improve.\n Although well received, this in-practice programme, which was designed to convey the current consensus on best practice for the care of depression, did not deliver improvements in recognition of or recovery from depression.", "Medical care is a team effort, especially as patient cases are more complex. Communication, cooperation, and coordination are vital to effective care, especially in complex service lines such as the operating room (OR). Team training, specifically the TeamSTEPPS training program, has been touted as one methodology for optimizing teamwork among providers and increasing patient safety. Although such team-training programs have transformed the culture and outcomes of other dynamic, high-risk industries such as aviation and nuclear power, evidence of team training effectiveness in health care is still evolving. Although providers tend to react positively to many training programs, evidence that training contributes to important behavioral and patient safety outcomes is lacking.\n A multilevel evaluation of the TeamSTEPPS training program was conducted within the OR service line with a control location. The evaluation was a mixed-model design with one between-groups factor (TeamSTEPPS training versus no training) and two within-groups factors (time period, team). The groups were located at separate campuses to minimize treatment diffusion. Trainee reactions, learning, behaviors in the OR, and proxy outcome measures such as the Hospital Survey on Patient Safety Culture (HSOPS) and Operating Room Management Attitudes Questionnaire (ORMAQ) were collected.\n All levels of evaluation demonstrated positive results. The trained group demonstrated significant increases in the quantity and quality of presurgical procedure briefings and the use of quality teamwork behaviors during cases. Increases were also found in perceptions of patient safety culture and teamwork attitudes.\n The hospital system has integrated elements of TeamSTEPPS into orientation training provided to all incoming hospital employees, including nonclinical staff.", "to determine the efficacy and effectiveness of training to improve primary care providers' patient-centered communication skills and proficiency in discussing their patients' health risks.\n twenty-eight primary care providers participated in a baseline simulated patient interaction and were subsequently randomized into intervention and control groups. Intervention providers participated in training focused on patient-centered communication about behavioral risk factors. Immediate efficacy of training was evaluated by comparing the two groups. Over the next 3 years, all providers participated in two more sets of interactions with patients. Longer term effectiveness was assessed using the interaction data collected at 6 and 18 months post-training.\n The intervention providers significantly improved in patient-centered communication and communication proficiencies immediately post-training and at both follow-up time points.\n this study suggests that the brief training produced significant and large differences in the intervention group providers which persisted 2 years after the training.\n the results of this study suggest that primary care providers can be trained to achieve and maintain gains in patient-centered communication, communication skills and discussion of adverse childhood events as root causes of chronic disease.\n 2010 Elsevier Ireland Ltd. All rights reserved.", "To evaluate the effectiveness of training and institutionalizing teamwork behaviors, drawn from aviation crew resource management (CRM) programs, on emergency department (ED) staff organized into caregiver teams.\n Nine teaching and community hospital EDs.\n A prospective multicenter evaluation using a quasi-experimental, untreated control group design with one pretest and two posttests of the Emergency Team Coordination Course (ETCC). The experimental group, comprised of 684 physicians, nurses, and technicians, received the ETCC and implemented formal teamwork structures and processes. Assessments occurred prior to training, and at intervals of four and eight months after training. Three outcome constructs were evaluated: team behavior, ED performance, and attitudes and opinions. Trained observers rated ED staff team behaviors and made observations of clinical errors, a measure of ED performance. Staff and patients in the EDs completed surveys measuring attitudes and opinions.\n Hospital EDs were the units of analysis for the seven outcome measures. Prior to aggregating data at the hospital level, scale properties of surveys and event-related observations were evaluated at the respondent or case level.\n A statistically significant improvement in quality of team behaviors was shown between the experimental and control groups following training (p = .012). Subjective workload was not affected by the intervention (p = .668). The clinical error rate significantly decreased from 30.9 percent to 4.4 percent in the experimental group (p = .039). In the experimental group, the ED staffs' attitudes toward teamwork increased (p = .047) and staff assessments of institutional support showed a significant increase (p = .040).\n Our findings point to the effectiveness of formal teamwork training for improving team behaviors, reducing errors, and improving staff attitudes among the ETCC-trained hospitals.", "Diabetes care in our inner-city primary care clinic was suboptimal, despite provider education and performance feedback targeting improved adherence to evidence-based clinical guidelines. A crew resource management (CRM) intervention (communication and teamwork, process and workflow organisation, and standardised information debriefings) was implemented to improve diabetes care and patient outcomes.\n To assess the effect of the CRM intervention on adherence to evidence-based diabetes care standards, work processes, standardised clinical communication and patient outcomes.\n Time-series analysis was used to assess the effect on the delivery of standard diabetes services and patient outcomes among medically indigent adults (n = 619).\n The CRM principles were translated into useful process redesign and standardised care approaches. Significant improvements in microalbumin testing and associated patient outcome measures were attributed to the intervention.\n The CRM approach provided tools for management that, in the short term, enabled reorganisation and prevention of service omissions and, in the long term, can produce change in the organisational culture for continuous improvement.", "Client-centered care is a major aim of health care. In mental health, new client-centered treatment approaches that emphasize recovery, rehabilitation, and empowerment can improve outcomes for people with severe and persistent mental illness. However, these approaches are not widely used, in part because many clinicians lack the necessary competencies. The objective of this study was to evaluate the effectiveness of an innovative, consumer-led intervention, Staff Supporting Skills for Self-Help, which was designed to improve provider quality, empower mental health consumers, and promote mutual support.\n The study was conducted at five large community mental health provider organizations in two western states. One organization in each state received the intervention. The intervention included education, clinician-client dialogues, ongoing technical assistance, and support of self-help. It focused on client-centered care, rehabilitation, and recovery. A one-year controlled trial evaluated the effect of the intervention on clinicians' competencies, care processes, and the formation of mutual support groups. Outcomes were assessed by using competency assessment survey instruments and semistructured interviews with clinicians and managers.\n A total of 269 clinicians participated in the study: 151 in the intervention group and 118 in the control group. Compared with clinicians at the control organizations, clinicians at intervention organizations showed significantly greater improvement in education about care, rehabilitation methods, natural supports, holistic approaches, teamwork, overall competency, and recovery orientation.\n A feasible, consumer-led intervention improves provider competencies in domains that are necessary for the provision of high-quality care.", "Although substantial resources have been invested in communication skills training for clinicians, little research has been done to test the actual effect of such training on patient satisfaction.\n To determine whether clinicians' exposure to a widely used communication skills training program increased patient satisfaction with ambulatory medical care visits.\n Randomized, controlled trial.\n A not-for-profit group-model health maintenance organization in Portland, Oregon.\n 69 primary care physicians, surgeons, medical subspecialists, physician assistants, and nurse practitioners from the Permanente Medical Group of the Northwest.\n \"Thriving in a Busy Practice: Physician-Patient Communication,\" a communication skills training program consisting of two 4-hour interactive workshops. Between workshops, participants audiotaped office visits and studied the audiotapes.\n Change in mean overall score on the Art of Medicine survey (HealthCare Research, Inc., Denver, Colorado), which measures patients' satisfaction with clinicians' communication behaviors, and global visit satisfaction.\n Although participating clinicians' self-reported ratings of their communication skills moderately improved, communication skills training did not improve patient satisfaction scores. The mean score on the Art of Medicine survey improved more in the control group (0.072 [95% CI, -0.010 to 0.154]) than in the intervention group (0.030 [CI, -0.060 to 0.1201).\n \"Thriving in a Busy Practice: Physician-Patient Communication,\" a typical continuing medical education program geared toward developing clinicians' communication skills, is not effective in improving general patient satisfaction. To improve global visit satisfaction, communication skills training programs may need to be longer and more intensive, teach a broader range of skills, and provide ongoing performance feedback.", "To test whether a team training intervention in stroke rehabilitation is associated with improved patient outcomes.\n A cluster randomized trial of 31 rehabilitation units comparing stroke outcomes between intervention and control groups.\n Thirty-one Veterans Affairs medical centers.\n A total of 237 clinical staff on 16 control teams and 227 staff on 15 intervention teams. Stroke patients (N=487) treated by these teams before and after the intervention.\n The intervention consisted of a multiphase, staff training program delivered over 6 months, including: an off-site workshop emphasizing team dynamics, problem solving, and the use of performance feedback data; and action plans for process improvement; and telephone and videoconference consultations. Control and intervention teams received site-specific team performance profiles with recommendations to use this information to modify team process.\n Three patient outcomes: functional improvement as measured by the change in motor items of the FIM instrument, community discharge, and length of stay (LOS).\n For both the primary (stroke only) and secondary analyses (all patients), there was a significant difference in improvement of functional outcome between the 2 groups, with the percentage of stroke patients gaining more than a median FIM gain of 23 points increasing significantly more in the intervention group (difference in increase, 13.6%; P=.032). There was no significant difference in LOS or rates of community discharge.\n Stroke patients treated by staff who participated in a team training program were more likely to make functional gains than those treated by staff receiving information only. Team based clinicians are encouraged to examine their own team. (ClinicalTrials.gov identifier NCT00237757).", "To evaluate a system-change model of training from the Family Violence Prevention Fund and the Pennsylvania Coalition Against Domestic Violence for improving the effectiveness of emergency department (ED) response to intimate partner violence (IPV).\n An experimental design with outcomes measured at baseline, 9-12, and 18-24 months post-intervention. Twelve hospitals in Pennsylvania and California with 20,000-40,000 annual ED visits were randomly selected and randomly assigned to experimental and control conditions. Emergency department teams (physician, nurse, social worker) from each experimental hospital and a local domestic violence advocate participated in a two-day didactic information and team planning intervention.\n The experimental hospitals were significantly higher than the control hospitals on a staff knowledge and attitude measure (F = 5.57, p = 0.019), on all components of the \"culture of the ED\" system-change indicator (F = 5.72, p = 0.04), and in patient satisfaction (F = 15.43, p < 0.001) after the intervention. There was no significant difference in the identification rates of battered women (F = 0.411, p = 0.52) (although the linear comparison was in the expected direction) in the medical records of the experimental and control hospitals.\n A system-change model of IPV ED training was effective in improving staff attitudes and knowledge about battered women and in protocols and staff training, as well as patient information and satisfaction. However, change in actual clinical practice was more difficult to achieve and may be influenced by institutional policy.", "The prevalence of diabetes in Mexico among those 20-64 years of age has increased from 7.2% in 1993 to 10.7% in 2000. National population-based surveys in Mexico demonstrated that 50% of the total population with diabetes had blood glucose levels of 200mg/dl or higher. Thus, diabetes care has become one of the most important public health challenges in this country. The aim of the study was to improve the quality of diabetes care in primary health care centers using the chronic care model and the breakthrough series (BTS) collaborative methodology.\n Ten public health centers in the cities of Xalapa and Veracruz were randomly selected to participate in the project. Five of the health centers were randomly assigned to receive the intervention (intervention group) and the other five followed usual care (usual care group). The intervention was evaluated by A1c test before and after the intervention in both groups of patients. Patients were followed for 18 months from November 2002 to May 2004. Results were adjusted for the clustering of patients within practices and baseline measure.\n The proportion of people with good glycemic control (A1c<7%) among those in the intervention group increased from 28% before the intervention to 39% after the intervention. The proportion of patients achieving three or more quality improvement goals increased from 16.6% to 69.7% (p<0.001) among the intervention group while the usual care group experienced a non-significant decrease from 12.4% to 5.9% (p=0.118). The focus on the primary care team and the participation of people with diabetes were strategic elements incorporated into the methodology, expected to ensure sustainability of continued improvement of health outcomes.\n The intervention introduced modifications to solve problems identified by health teams in their practice and improved process and outcome measures of quality diabetes care. Most of the actions were directed at four components of the chronic care model: self-management support, decision support, delivery system design, and clinical information systems.\n Copyright © 2010 Primary Care Diabetes Europe. Published by Elsevier Ltd. All rights reserved.", "To evaluate the feasibility and effectiveness of a falls management program (FMP) for nursing homes (NHs).\n A quality improvement project with data collection throughout FMP implementation.\n NHs in Georgia owned and operated by a single nonprofit organization.\n All residents of participating NHs.\n A convenience sample of 19 NHs implemented the FMP. The FMP is a multifaceted quality improvement and culture change intervention. Key components included organizational leadership buy-in and support, a designated facility-based falls coordinator and interdisciplinary team, intensive education and training, and ongoing consultation and oversight by advanced practice nurses with expertise in falls management.\n Process-of-care documentation using a detailed 24-item audit tool and fall and physical restraint use rates derived from quality improvement software currently used in all Georgia NHs (MyInnerView).\n Care process documentation related to the assessment and management of fall risk improved significantly during implementation of the FMP. Restraint use decreased substantially during the project period, from 7.9% to 4.4% in the intervention NHs (a relative reduction of 44%), and decreased in the nonintervention NHs from 7.0% to 4.9% (a relative reduction of 30%). Fall rates remained stable in the intervention NHs (17.3 falls/100 residents per month at start and 16.4 falls/100 residents per month at end), whereas fall rates increased 26% in the NHs not implementing the FMP (from 15.0 falls/100 residents/per month to 18.9 falls/100 residents per month).\n Implementation was associated with significantly improved care process documentation and a stable fall rate during a period of substantial reduction in the use of physical restraints. In contrast, fall rates increased in NHs owned by the same organization that did not implement the FMP. The FMP may be a helpful tool for NHs to manage fall risk while attempting to reduce physical restraint use in response to the Centers for Medicare and Medicaid Services quality initiatives." ]

[ "3172378", "1999863", "920124" ]

[ "One-stage versus two-stage amputation for wet gangrene of the lower extremity: a randomized study.", "Skewflap versus long posterior flap in below-knee amputations: multicenter trial.", "Below-knee amputation for ischaemic gangrene. Prospective, randomized comparison of a transverse and a sagittal operative technique." ]

[ "Although the two-stage amputation technique entails an additional operation, several authors have advocated this approach to deal with wet gangrene because it allows primary wound closure with a reduced chance of wound infection. To examine this issue, 47 patients with necrotizing wet gangrene of the foot were randomized prospectively to receive either a one-stage amputation (definitive below- or above-knee amputation with delayed secondary skin closure in 3 to 5 days) or a two-stage amputation (open ankle guillotine amputation followed by definitive, closed below- or above-knee amputation). Antibiotic coverage was standardized with clindamycin and gentamicin used in all patients. Preoperative blood cultures and intraoperative foot cultures were obtained, as well as cultures from the deep muscle and lymphatic area along the saphenous vein to determine the presence of bacteria at the level of initial amputation. Twenty-four patients (11 diabetic and 13 nondiabetic) were randomized to the one-stage procedure. Twenty-three patients (14 diabetic and nine nondiabetic) were randomized to the two-stage procedure. Five of 24 patients in the one-stage group (21%) had positive muscle cultures vs 10 of 23 patients in the two-stage group (43%). Two of 24 patients in the one-stage group (8%) had positive lymphatic cultures vs 7 of 23 patients in the two-stage group (30%). Five of 24 patients in the one-stage group (21%) had wound complications attributable to the amputation technique vs none of 23 patients in the two-stage group (p = 0.05).(ABSTRACT TRUNCATED AT 250 WORDS)", "A multicenter trial of alternative techniques for below-knee amputation is described in which surgeons in 11 centers randomized 191 patients with end-stage occlusive vascular disease to two different methods of stump construction. The skewflap technique was performed in 98 and the long posterior flap was performed in 93. The two groups were well matched in respect to age, sex, smoking, diabetes, and indications for amputation. Early outcome was compared in terms of 30-day mortality rate: skew 11 (11%) deaths versus long posterior flap 16 (17%); the state of the wound at 1 week (primary healing 60% in both groups); the need for surgical revision at the same level 7 (7%) versus 7 (8%), and revision to a higher level 10 (10%) versus 7 (8%). Follow-up information at 6 months was available from records or by mailed questionnaire in 188 (98%) at 6 months, 20 died during that interval. It showed that a prosthetic limb was fitted to 64 (84%) of skew flaps and 50 (77%) of long posterior flaps. Walking, alone or with support, was achieved in 59 (78%) and 46 (71%), respectively. None of these differences reached statistical significance. It is concluded that the skew flap is just as effective as the long posterior flap and is an excellent option for below-knee amputation.", "In a prospective, randomized study a comparison was made of the results of primary below-knee amputation for ischaemic gangrene carried out by two methods: In 47 cases by the transverse technique with a long posterior musculo-cutaneous flap and in 41 cases by the sagittal technique using equally large medial and lateral musculo-cutaneous flaps--in both instances followed by 2 weeks in a half-open plaster cast with extended knee. The sex ratio and age distribution were the same in both groups. Minor differences in the vascular condition between the groups, assessed by the duration of rest pain, pulsation findings, extent of gangrene, and frequency of diabetes, wholly or partially equalized each other. The course of healing was the same in both groups, primary healing being attained in 38 per cent and 41 per cent, respectively (0.70 less than P less than 0.80). There was also no difference between the results as regards limb fitting, ambulation, occupational, or social status. It is concluded that the choice between the two methods can be based merely upon surgical skill and the ischaemic changes in the lower leg." ]

[ "8194298", "17429240", "7931883", "1297921", "9504788", "10591428", "10730039", "7612090", "1733156", "1408537", "10654954", "2213261", "9340608", "7748680", "1628468", "8695998" ]

[ "Ohmeda Biliblanket vs Wallaby Phototherapy System for the reduction of bilirubin levels in the home-care setting.", "Fiberoptic, conventional and combination phototherapy for treatment of nonhemolytic hyperbilirubinemia in neonates.", "Comparison of the efficacy of fiberoptic and conventional phototherapy for neonatal hyperbilirubinemia.", "[A new device for phototherapy of neonatal jaundice].", "Fibre optic versus conventional phototherapy for hyperbilirubinaemia in preterm infants.", "Comparison of the efficacy of conventional special blue light phototherapy and fiberoptic phototherapy in the management of neonatal hyperbilirubinaemia.", "Double versus single phototherapy in term newborns with significant hyperbilirubinemia.", "Double phototherapy with high irradiance compared with single phototherapy in neonates with hyperbilirubinemia.", "A clinical trial of fiberoptic phototherapy vs conventional phototherapy.", "Double versus single phototherapy in low birth weight newborns.", "Changes in mesenteric blood flow response to feeding: conventional versus fiber-optic phototherapy.", "A randomized, controlled application of the Wallaby phototherapy system compared with standard phototherapy.", "[Double phototherapy with Wallaby optic fibers versus conventional phototherapy. Case reports].", "BiliBlanket phototherapy system versus conventional phototherapy: a randomized controlled trial in preterm infants.", "A new light on jaundice. A pilot study.", "Fibreoptic phototherapy in the management of jaundice in low birthweight neonates." ]

[ "nan", "The objective of this prospective, randomized study was to compare the effectiveness of fiberoptic, conventional and a combination phototherapy in decreasing bilirubin concentrations in neonatal nonhemolytic hyperbilirubinemia. Forty-six infants who were 36 weeks' gestation and more were randomly assigned to fiberoptic phototherapy (n=16) (Biliblanket, Ohmeda), conventional daylight phototherapy (n=15) and combination phototherapy (n=15) (fiberoptic and conventional). The groups were similar in clinical characteristics at study entry in terms of birth weight, age and bilirubin concentration. There were no statistically significant differences in the duration of treatment among the three groups (P=0.83). There were also no statistically significant differences among the three groups in the serum bilirubin concentrations at 24 hours, 48 hours, end of phototherapy, and 24 hours postphototherapy. We concluded that the decrease in serum bilirubin concentration was comparable among fiberoptic, conventional and combination phototherapy groups.", "A comparative evaluation of the efficacy of fiberoptic phototherapy using the Ohmeda Billiblanket fiberoptic device, conventional phototherapy using daylight fluorescent lamps, and a combination of the two forms of phototherapy was made in 165 term healthy infants and 105 preterm infants with hyperbilirubinemia. In the term infants, the 24-hour decline rate for fiberoptic phototherapy was 9.2% +/- 1.6% (mean +/- SEM) versus 21.5% +/- 1.8% for daylight phototherapy (p < 0.01), and the overall decline rate was 0.49% +/- 0.03%/hr versus 0.70% +/- 0.04%/hr (p < 0.001). Combination phototherapy, with a 24-hour decline rate of 29.9% +/- 1.0% and an overall decline rate of 0.97% %/- 0.04%/hr, was significantly better than daylight phototherapy in both respects (p < 0.01 and < 0.01, respectively). The duration of exposure for fiberoptic phototherapy was significantly longer than that for daylight phototherapy, which in turn was significantly longer than that for combination phototherapy. Response to exposure in the preterm infants was significantly better than that in the term infants with the respective types of phototherapy. The nursing personnel unanimously felt more comfortable with fiberoptic phototherapy, which did not disturb the swaddled infants as much as conventional phototherapy. The parents also felt more reassured. Fiberoptic phototherapy proved adequate in controlling hyperbilirubinemia in preterm infants; in term infants, failures often occurred. Combination phototherapy can be recommended for severe or rapidly increasing jaundice in preterm infants, but its efficacy in term infants is uncertain.", "The effectiveness of a new device for phototherapy in the treatment of nonhemolytic hyperbilirubinemia (Wallaby Phototherapy System) was evaluated. 46 healthy term infants, appropriate for gestational age and with serum bilirubin > 12 mg/dl in the first 3 days of life or > 15 mg/dl after 3rd day were randomly assigned to a treatment group (24 hours of light exposure with Wallaby Phototherapy System) and to a control group (any treatment for hyperbilirubinemia). Body temperature, weight, feeding and hydration were recorded during the study period. Serum bilirubin and haematocrit were done every 12 hours in all babies. In the treated group we found a decrease of 5.1% and of 7.8% at 12 and 24 hours, while an increase of 3.37% and of 2.9% at 12 and 24 hours was found in the control group. After 24 hours the serum bilirubin level was significantly lower in the treated group than in the control group (p < 0.05). No newborn of the treated group needed conventional phototherapy versus 4 control infants (17.4%). The conclusion of our study is that the Wallaby System is useful in the treatment of neonatal nonhemolytic hyperbilirubinemia even if its effectiveness for higher bilirubin levels has still to be tested.", "Studies comparing efficacy of fibre optic phototherapy to conventional phototherapy are performed mostly in term infants and give conflicting results. This randomized prospective study compares efficacy of fibre optic phototherapy using the Ohmeda Biliblanket device to conventional fluorescent phototherapy in preterm infants. A total of 124 preterm infants with a nonhaemolytic hyperbilirubinaemia were evaluated. Stratification at randomisation was performed according to birth weight ( < 1000 g, 1000-1500 g or 1500-2000 g). Fifty-six infants received fibre optic and 68 conventional phototherapy. Efficacy was assessed by comparing the required duration of phototherapy. Median duration of phototherapy was 118 h and 114 h in the fibre optic and conventional groups respectively, the difference in which was not statistically significant. The median durations were also not significantly different within the separate weight groups. The number of infants requiring exchange transfusions was similar in both treatment groups.\n The efficacy of fibre optic phototherapy in preterm infants is comparable to conventional phototherapy.", "The efficacy and usefulness of two types of phototherapy differing in the source, wavelength and irradiance of the light, conventional phototherapy consisting of special blue light and fiberoptic phototherapy, were compared in a relatively larger series of term newborns with non-haemolytic and more significant hyperbilirubinaemia than those in previous studies. In total, 108 newborns were allocated sequentially to receive either conventional phototherapy consisting of five special blue lamps or fiberoptic phototherapy. The average spectral irradiance measured at the skin surface level of newborns during the study period was significantly greater in the conventional phototherapy group. The special blue lamp of the conventional phototherapy unit had an emission spectrum almost identical to the bilirubin absorption spectrum, whereas the tungsten-halogen lamp of the fiberoptic phototherapy had a broad emission through the blue and green wavelengths (mainly in the green spectrum). Phototherapy was more effective in the conventional phototherapy group; the duration of exposure to phototherapy (h) was significantly shorter, and the overall bilirubin decline rate (as micromol/l/h and %/h) was significantly greater in the conventional phototherapy group. According to the nursing personnel, fiberoptic phototherapy was more comfortable than the conventional phototherapy frame because of the easier accessibility and handling of the infants during phototherapy. They complained of giddiness, nausea, glare, temporary blurring of vision and difficulty in detecting the skin colour changes of newborns with the blue light of the conventional phototherapy unit. Conventional phototherapy consisting of special blue fluorescent lamps with approximately twofold higher irradiance and an emission spectrum almost identical to the bilirubin absorption spectrum is preferable to fiberoptic phototherapy in the standard treatment of term newborns with non-haemolytic hyperbilirubinaemia.", "The efficacy of double phototherapy, in the form of conventional phototherapy with special blue light plus fiberoptic phototherapy, was compared with conventional phototherapy consisting of special blue lamps alone in a relatively larger series of term newborns with significant hyperbilirubinemia. During the study period the sum of the average spectral irradiances in the double phototherapy group was significantly higher than that of the single phototherapy group (p < 0.05). Phototherapy was effective in decreasing bilirubin levels in both groups, but the response was greater in the double phototherapy group; the duration of exposure to phototherapy was significantly shorter (31.2 +/- 8.5 vs. 38.98 +/- 14.7 h, p < 0.05), and the overall bilirubin decline rate as mumol/l/h and per cent/h was significantly greater in the double phototherapy group (4.1 +/- 1.37 vs. 3.3 +/- 0.86 mumol/l/h, and 1.29 +/- 0.38 vs. 1.02 +/- 0.44 per cent/h, p < 0.05). In phototherapy treatment of term newborns with significant hyperbilirubinemia, double phototherapy provided more rapid and effective bilirubin reduction than conventional phototherapy alone due to higher spectral irradiance and larger body surface area exposed to phototherapy. The value of double phototherapy in the treatment of newborns with hemolytic hyperbilirubinemia remains to be determined.", "The purpose of this study is to compare the effectiveness of double phototherapy versus single conventional phototherapy in decreasing serum bilirubin levels in jaundiced neonates. Forty-two preterm infants who were less than 37 weeks' gestational age and less than 2000 g birthweight with nonhemolytic jaundice were alternately assigned to double phototherapy (n = 19) (Biliblanket, Ohmeda with irradiance of 33 to 35 microW/cm2/nm in addition to single conventional phototherapy with combination of three or four special blue and white lamps with irradiance of 7 to 9 microW/cm2/nm) or to single conventional phototherapy (n = 23) based on elevated serum bilirubin levels in the first week of life. Phototherapy was initiated at specific bilirubin levels in three weight stratifications. The groups were similar in clinical characteristics at study entry. The decrease in serum bilirubin levels was very significant in the double phototherapy group at 8 hours after the therapy (-29 +/- 18.8 versus 8.5 +/- 27 mumol/L; P < 0.001), at 16 hours after the therapy (-49.6 +/- 15.4 versus 3.4 +/- 39 mumol/L; p < 0.001), and at 24 hours after therapy (-71.8 +/- 18.8 versus -3.4 +/- 32.5 mumol/L; p < 0.001) compared with the conventional phototherapy group. The time taken for bilirubin levels to fall below the threshold level was 55 +/- 41 hours in the single group and 14 +/- 6 hours in the double group (p < 0.001). Double phototherapy was well tolerated. The Biliblanket when used in conjunction with single conventional phototherapy resulted in a faster decrease of serum bilirubin.(ABSTRACT TRUNCATED AT 250 WORDS)", "We conducted a randomized, controlled trial to compare fiberoptic phototherapy with conventional phototherapy in healthy jaundiced newborns with birth weights greater than 2500 g. Twelve patients received fiberoptic phototherapy and 14 patients received conventional phototherapy. There were no significant differences between the groups with respect to birth weight, gestational age, feeding method, presence of hemolytic disease, hematocrit, reticulocyte count, or initial serum bilirubin level. Measured irradiance at 425 to 475 nm for conventional phototherapy was greater than that of fiberoptic phototherapy (9.2 +/- 0.9 microW/cm2 per nanometer vs 8.2 +/- 1.2 microW/cm2 per nanometer). Both types of phototherapy lowered the level of serum bilirubin after 18 hours of therapy (fiberoptic group, from 231 +/- 29 to 210 +/- 24 mumol/L; conventional group, from 231 +/- 21 to 188 +/- 26 mumol/L), but the mean serum bilirubin level was lower after 18 hours of therapy in the conventional phototherapy group (188 +/- 26 vs 210 +/- 24 mumol/L). There were no side effects in either group of newborns. Both methods of phototherapy decreased the serum bilirubin level, but conventional phototherapy did so more effectively, probably because of its greater irradiance.", "Conventional phototherapy systems that simultaneously irradiate the front and the back of the baby lower the serum bilirubin level more rapidly than one-sided systems, but they are impractical. Fiberoptic phototherapy makes it easy to administer conventional phototherapy from above while the infant lies on a fiberoptic phototherapy blanket. Newborns with birth weights less than 2500 g were randomly assigned to receive either single (n = 37) or double (n = 33) phototherapy. The groups were similar in clinical and laboratory characteristics. After 18 hours of therapy the serum bilirubin concentration declined by 31 +/- 11% in the double and 16 +/- 15% in the single phototherapy group (2.9 +/- 1.1 vs 1.6 +/- 1.4 mg/dL), and the difference in the total serum bilirubin levels after 18 hours of therapy was significant (double phototherapy group 7.1 +/- 2.7 mg/dL vs single phototherapy group 8.2 +/- 2.6 mg/dL). After 18 hours of treatment the serum bilirubin level was less than the phototherapy threshold level in 26 of 37 single phototherapy patients vs 32 of 33 double phototherapy patients. Double phototherapy was well tolerated. It is concluded that this type of double phototherapy is more effective than single phototherapy in low birth weight newborns. Double phototherapy may be useful when it is necessary to reduce an elevated serum bilirubin level as rapidly as possible or when the bilirubin level is rising with single phototherapy.", "To evaluate whether fiberoptic phototherapy influences the postprandial increase in mesenteric blood flow velocity similarly to conventional phototherapy in preterm infants.\n With the use of Doppler color ultrasonography, blood flow velocity in the superior mesenteric artery was measured both preprandially and postprandially in 19 preterm infants during and after conventional phototherapy, and in 20 preterm infants during and after fiber-optic phototherapy. The mean arterial blood pressure/mean flow velocity ratio was calculated as an estimate of relative vascular resistance of the superior mesenteric artery.\n The study shows that conventional phototherapy blunts the postprandial mesenteric blood flow response to feeding in preterm infants. Furthermore, it shows that the postprandial increase in intestinal blood flow is not attenuated when fiber-optic phototherapy is administered, and that such postprandial increase of blood flow is significantly greater than in infants receiving conventional phototherapy. During and after fiber-optic phototherapy, a significant reduction in postprandial relative vascular resistance was found; such reduction was significantly greater than during conventional phototherapy.\n Fiber-optic phototherapy is preferable to conventional phototherapy for the treatment of hyperbilirubinemia in preterm infants because it does not affect the physiologic postprandial redistribution of blood flow from the periphery to the gastrointestinal system as does conventional phototherapy.", "The feasibility and efficacy of a fiberoptic blanket (Wallaby Phototherapy System) for the treatment of physiologic jaundice was compared with conventional phototherapy. Forty-two full-term infants with nonhemolytic jaundice were included in the study. Infants in the study group were treated with the fiberoptic blanket and the infants in the control group were placed under a standard phototherapy unit. Both the fiberoptic blanket and the standard phototherapy unit delivered an average irradiance of 7.0 +/- 0.5 muw/cm2/nm. Incremental changes in serial plasma bilirubin levels compared with the initial bilirubin concentration did not differ between the study and control groups. For infants whose initial plasma bilirubin concentration exceeded 200 mumol/L, a statistically significant difference was found in both study and control groups between the average bilirubin level at initiation of phototherapy and the average bilirubin level at termination of treatment. We conclude that phototherapy delivered by the fiberoptic blanket is safe and has efficacy comparable to that of conventional phototherapy, providing a convenient alternative phototherapy application strategy that obviates the need for eye patches and facilitates maternal handling of the infant during therapy.", "The authors have valued the efficacy of the double phototherapy with fiberoptic Wallaby vs conventional phototherapy in 2 groups of term infants, without any complication at birth, utilized respectively as study group and control group. While conventional phototherapy produced a bilirubin reduction of 0.60 +/- 0.26% per hour (with a total reduction of 28.1 +/- 11.1%), the double phototherapy was statistically more effective (p < 0.05) then conventional phototherapy causing a bilirubin reduction of 0.73 +/- 0.28% (with a total reduction of 33.3 +/- 9.5%). At 24 hour after the interruption of the treatment 9 newborns of the study group (36%) and 7 of the control group (28%) presented a rebound effect (increase of the bilirubinemia more than 17 mumol/l), but without a statistical difference (p > 0.05). Our study shows that double phototherapy with Wallaby fiberoptic and conventional phototherapy represent a valid strategy in the treatment of the non haemolytic neonatal hyperbilirubinemia, because, compared to conventional phototherapy, double phototherapy is more effective and reduces the period of the treatment, showing a simple management of the jaundiced newborn.", "This study compares the use of standard overhead fluorescent phototherapy units with the BiliBlanket a woven fibreoptic pad which delivers high intensity light with no ultraviolet or infrared irradiation in the treatment of jaundice in preterm infants.\n We chose to study infants between 800 and 2500 g, with strict criteria for commencing and ceasing phototherapy. Serum bilirubin levels were followed at 12-24 h intervals until 24 h after cessation of phototherapy. Infants were allocated at random to receive either conventional phototherapy or the BiliBlanket.\n There were 24 infants in the conventional group and 20 in the BiliBlanket group. Mean duration of phototherapy was compared and was 44 h for the conventional group versus 42 h for the BiliBlanket group.\n We have shown that the BiliBlanket is as effective as conventional phototherapy and was well accepted by nursing staff and parents.", "nan", "A fibreoptic phototherapy device has been compared with conventional white and special blue fluorescent phototherapy lamps to evaluate its efficacy in lowering serum bilirubin levels in low-birthweight neonates. Fibreoptic phototherapy was found to be as effective as white light and less effective than blue light, as assessed by (i) the bilirubin concentration after 24 h of phototherapy and at the end of phototherapy, (ii) the duration of phototherapy, (iii) the percentage daily decline rate and (iv) the overall percentage decline rate (p < 0.05). There were no failures of phototherapy and the need for re-exposure was low (4.7% of the total sample), with no difference between groups. The fibreoptic approach represents a promising way to aggregate synergically the most recent optical technologies and develop a modern, efficient and caring phototherapy system for low-birthweight infants." ]

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[ "Laparoscopic adjustable gastric banding versus open vertical banded gastroplasty: a prospective randomized trial.", "Adjustable gastric banding and conventional therapy for type 2 diabetes: a randomized controlled trial.", "Open versus laparoscopic adjustable silicone gastric banding: a prospective randomized trial for treatment of morbid obesity.", "Treatment of mild to moderate obesity with laparoscopic adjustable gastric banding or an intensive medical program: a randomized trial.", "Laparoscopic versus open gastric bypass: a randomized study of outcomes, quality of life, and costs.", "Laparoscopic adjustable gastric banding versus Roux-en-Y gastric bypass: 5-year results of a prospective randomized trial.", "Sex hormone-binding globulin levels and cardiovascular risk factors in morbidly obese subjects before and after weight reduction induced by diet or malabsorptive surgery.", "Prospective randomized trial of banded versus nonbanded gastric bypass for the super obese: early results.", "Randomized clinical trial of laparoscopic Roux-en-Y gastric bypass versus laparoscopic vertical banded gastroplasty for obesity.", "Changes of body weight and plasma ghrelin levels after gastric banding and gastric bypass.", "Physical and psychosocial outcome in morbidly obese patients with and without bariatric surgery: a 4 1/2-year follow-up.", "Prospective randomised comparison of adjustable gastric banding and vertical banded gastroplasty for morbid obesity.", "Gastric Bypass and Vertical Banded Gastroplasty- a Prospective Randomized Comparison and 5-Year Follow-up.", "Cost of in-patient care over 7 years among surgically and conventionally treated obese patients.", "A randomized prospective trial of gastric bypass versus vertical banded gastroplasty for morbid obesity and their effects on sweets versus non-sweets eaters.", "Weight loss, appetite suppression, and changes in fasting and postprandial ghrelin and peptide-YY levels after Roux-en-Y gastric bypass and sleeve gastrectomy: a prospective, double blind study.", "Laparoscopic versus open gastric bypass in the treatment of morbid obesity: a randomized prospective study.", "Randomized clinical trial of hand-assisted laparoscopic versus open Roux-en-Y gastric bypass for the treatment of morbid obesity.", "Surgery for Obesity- An Update of a Randomized Trial.", "A prospective randomized study between laparoscopic gastric banding and laparoscopic isolated sleeve gastrectomy: results after 1 and 3 years.", "Laparoscopic vs open Roux-en-Y gastric bypass: a prospective, randomized trial.", "Laparoscopic vertical banded gastroplasty and laparoscopic gastric bypass: a comparison.", "Open versus laparoscopic vertical banded gastroplasty: a randomized controlled double blind trial.", "Laparoscopic adjustable silicone gastric banding versus vertical banded gastroplasty in morbidly obese patients: a prospective randomized controlled clinical trial." ]

[ "Laparoscopic adjustable gastric banding (LAGB) and open vertical banded gastroplasty (VBG) are treatment modalities for morbid obesity. However, few prospective randomized clinical trials (RCT) have been performed to compare both operations.\n 100 patients (50 per group) were included in the study. Postoperative outcomes included hospital length of stay (LOS), complications, percent excess weight loss (%EWL), BMI and reduction in total comorbidities. Follow-up in all patients was 2 years.\n LOS was significantly shorter in the LAGB group. 3 LAGB were converted to open (1 to gastric bypass). Directly after VBG, 3 patients needed relaparotomies due to leakage, of which one (2%) died. After 2 years, 100% follow-up was achieved. BMI and %EWL were significantly decreased in both groups but significantly more in the VBG group compared to the LAGB group (31.0 kg/m2 and 70.1% vs 34.6 and 54.9% respectively). Co-morbidities significantly decreased in both groups in time. 2 years after LAGB, 20 patients needed reoperation for pouch dilation/slippage (n=12), band leakage (n=2), band erosion (n=2) and access-port problems (n=4). In the VBG group, 18 patients needed revisional surgery due to staple-line disruption (n=15), narrow outlet (n=2) or insufficient weight loss (n=1). Furthermore, 8 VBG patients developed an incisional hernia.\n This RCT demonstrates that, despite the initial better weight loss in the VBG group, based on complication rates and clinical outcome, LAGB is preferred. It had a shorter LOS and less postoperative morbidity.", "Observational studies suggest that surgically induced loss of weight may be effective therapy for type 2 diabetes.\n To determine if surgically induced weight loss results in better glycemic control and less need for diabetes medications than conventional approaches to weight loss and diabetes control.\n Unblinded randomized controlled trial conducted from December 2002 through December 2006 at the University Obesity Research Center in Australia, with general community recruitment to established treatment programs. Participants were 60 obese patients (BMI >30 and <40) with recently diagnosed (<2 years) type 2 diabetes.\n Conventional diabetes therapy with a focus on weight loss by lifestyle change vs laparoscopic adjustable gastric banding with conventional diabetes care.\n Remission of type 2 diabetes (fasting glucose level <126 mg/dL [7.0 mmol/L] and glycated hemoglobin [HbA1c] value <6.2% while taking no glycemic therapy). Secondary measures included weight and components of the metabolic syndrome. Analysis was by intention-to-treat.\n Of the 60 patients enrolled, 55 (92%) completed the 2-year follow-up. Remission of type 2 diabetes was achieved by 22 (73%) in the surgical group and 4 (13%) in the conventional-therapy group. Relative risk of remission for the surgical group was 5.5 (95% confidence interval, 2.2-14.0). Surgical and conventional-therapy groups lost a mean (SD) of 20.7% (8.6%) and 1.7% (5.2%) of weight, respectively, at 2 years (P < .001). Remission of type 2 diabetes was related to weight loss (R2 = 0.46, P < .001) and lower baseline HbA1c levels (combined R2 = 0.52, P < .001). There were no serious complications in either group.\n Participants randomized to surgical therapy were more likely to achieve remission of type 2 diabetes through greater weight loss. These results need to be confirmed in a larger, more diverse population and have long-term efficacy assessed.\n actr.org Identifier: ACTRN012605000159651.", "To perform the first prospective trial of laparoscopic versus open adjustable silicone gastric banding (ASGB) in patients with morbid obesity.\n Vertical banded gastroplasty has been used for many years to treat morbid obesity, but the size of the stoma has remained a source of failure after the procedure. ASGB has the advantages of maintaining gastric integrity and the potential for readjustment of the band, if needed. It has been suggested that laparoscopic ASGB, recently introduced to reduce postoperative complications and hospital stay, has a negative impact on outcome.\n Fifty patients with morbid obesity of >5 years' duration and a body-mass index (BMI) > 40 kg/m2 were randomized to undergo laparoscopic or open ASGB. The difficulty of the procedure, surgical time, postoperative complications, and hospital stay were assessed. Stoma adjustments, long-term complications, readmissions, weight loss, and BMI were determined.\n All procedures were successfully carried out. Of 25 patients assigned to laparoscopic ASGB, 2 were converted to an open procedure. Surgical time was significantly longer for laparoscopic ASGB (150 minutes vs. 76 minutes for open ASGB). There was no difference in complications. Mean hospital stay was 5.9 days for the laparoscopic procedure versus 7.2 days for open ASGB (p < 0.05). The total number of readmissions (6 vs. 15) and overall hospital stay in the first year (7.8 vs. 11.8 days) were lower after laparoscopic ASGB (p < 0.05). Weight and BMI were reduced significantly in both groups, but there was no difference between the groups.\n Laparoscopic and open ASGB were equally effective in terms of early (first-year) weight loss, reduction of BMI, and postoperative complications. The laparoscopic procedure was associated with a shorter initial hospital stay and fewer readmissions during follow-up and is therefore the preferred treatment in morbidly obese patients undergoing ASGB.", "Obesity is a major, growing health problem. Observational studies suggest that bariatric surgery is more effective than nonsurgical therapy, but no randomized, controlled trials have confirmed this.\n To ascertain whether surgical therapy for obesity achieves better weight loss, health, and quality of life than nonsurgical therapy.\n Randomized, controlled trial.\n University departments of medicine and surgery and an affiliated private hospital.\n 80 adults with mild to moderate obesity (body mass index, 30 kg/m2 to 35 kg/m2) from the general community. Interventions: Patients were assigned to a program of very-low-calorie diets, pharmacotherapy, and lifestyle change for 24 months (nonsurgical group) or to placement of a laparoscopic adjustable gastric band (LAP-BAND System, INAMED Health, Santa Barbara, California) (surgical group).\n Outcome measures were weight change, presence of the metabolic syndrome, and change in quality of life at 2 years.\n At 2 years, the surgical group had greater weight loss, with a mean of 21.6% (95% CI, 19.3% to 23.9%) of initial weight lost and 87.2% (CI, 77.7% to 96.6%) of excess weight lost, while the nonsurgical group had a loss of 5.5% (CI, 3.2% to 7.9%) of initial weight and 21.8% (CI, 11.9% to 31.6%) of excess weight (P < 0.001). The metabolic syndrome was initially present in 15 (38%) patients in each group and was present in 8 (24%) nonsurgical patients and 1 (3%) surgical patient at the completion of the study (P < 0.002). Quality of life improved statistically significantly more in the surgical group (8 of 8 subscores of Short Form-36) than in the nonsurgical group (3 of 8 subscores).\n The study included mildly and moderately obese participants, was not powered for comparison of adverse events, and examined outcomes only for 24 months.\n Surgical treatment using laparoscopic adjustable gastric banding was statistically significantly more effective than nonsurgical therapy in reducing weight, resolving the metabolic syndrome, and improving quality of life during a 24-month treatment program.", "To compare outcomes, quality of life (QOL), and costs of laparoscopic and open gastric bypass (GBP).\n Laparoscopic GBP has been reported to be a safe and effective approach for the treatment of morbid obesity. The authors performed a prospective randomized trial to compare outcomes, QOL, and costs of laparoscopic GBP with those of open GBP.\n From May 1999 to March 2001, 155 patients with a body mass index (BMI) of 40 to 60 kg/m2 were randomly assigned to undergo laparoscopic (n = 79) or open (n = 76) GBP. The two groups were similar in age, sex ratio, mean BMI, and comorbidities. Main outcome measures included operative time, estimated blood loss, length of hospital stay, operative complications, percentage of excess body weight loss, and time to return to activities of daily living and work. Changes in QOL were assessed using the SF-36 Health Survey and the bariatric analysis of reporting outcome system (BAROS). Operative and hospital costs of the two operations were also compared.\n There were no deaths in either group. Mean operative time was longer for laparoscopic GBP than for open GBP, but operative blood loss was less. Two (2.5%) of the 79 patients in the laparoscopic group required conversion to laparotomy. Median length of hospital stay was shorter for laparoscopic GBP patients (3 vs 4 days). The rate of postoperative anastomotic leak was similar between groups. Wound-related complications such as infection (10.5 vs 1.3%) and incisional hernia (7.9 vs 0%) were more common after open GBP; late anastomotic stricture was less frequent after open GBP (2.6 vs 11.4%). Time to return to activities of daily living and work were shorter after laparoscopic GBP than after open GBP. Weight loss at 1 year was similar between groups. Preoperative SF-36 scores were similar between groups; however, at 1 month after surgery, laparoscopic patients had better physical conditioning, social functioning, general health, and less body pain than open GBP patients. At 6 months, the BAROS outcome was classified as good or better in 97% of laparoscopic GBP patients compared with 82% of open GBP patients. Operative costs were higher for laparoscopic GBP patients, but hospital costs were lower.\n Laparoscopic GBP is a safe and cost-effective alternative to open GBP. Despite a longer operative time, patients undergoing laparoscopic GBP benefited from less blood loss, a shorter hospital stay, and faster convalescence. Laparoscopic GBP patients had comparable weight loss at 1 year but a more rapid improvement in QOL than open GBP patients. The higher initial operative costs for laparoscopic GBP were adequately offset by the lower hospital costs.", "To perform a prospective, randomized comparison of laparoscopic adjustable gastric banding (LAGB) and laparoscopic Roux-en-Y gastric bypass (LRYGB).\n LAGB, using the pars flaccida technique, and standard LRYGB were performed. From January 2000 to November 2000, 51 patients (mean age 34.0 +/- 8.9 years, range 20-49) were randomly allocated to undergo either LAGB (n = 27, 5 men and 22 women, mean age 33.3 years, mean weight 120 kg, mean body mass index [BMI] 43.4 kg/m(2); percentage of excess weight loss 83.8%) or LRYGB (n = 24, 4 men and 20 women, mean age 34.7, mean weight 120 kg, mean BMI 43.8 kg/m(2), percentage of excess weight loss 83.3). Data on the operative time, complications, reoperations with hospital stay, weight, BMI, percentage of excess weight loss, and co-morbidities were collected yearly. Failure was considered a BMI of >35 at 5 years postoperatively. The data were analyzed using Student's t test and Fisher's exact test, with P <.05 considered significant.\n The mean operative time was 60 +/- 20 minutes for the LAGB group and 220 +/- 100 minutes for the LRYGB group (P <.001). One patient in the LAGB group was lost to follow-up. No patient died. Conversion to laparotomy was performed in 1 (4.2%) of 24 LRYGB patients because of a posterior leak of the gastrojejunal anastomosis. Reoperations were required in 4 (15.2%) of 26 LAGB patients, 2 because of gastric pouch dilation and 2 because of unsatisfactory weight loss. One of these patients required conversion to biliopancreatic diversion; the remaining 3 patients were on the waiting list for LRYGB. Reoperations were required in 3 (12.5%) of the 24 LRYGB patients, and each was because of a potentially lethal complication. No LAGB patient required reoperation because of an early complication. Of the 27 LAGB patients, 3 had hypertension and 1 had sleep apnea. Of the 24 LRYGB patients, 2 had hyperlipemia, 1 had hypertension, and 1 had type 2 diabetes. Five years after surgery, the diabetes, sleep apnea, and hyperlipemia had resolved. At the 5-year (range 60-66 months) follow-up visit, the LRYGB patients had significantly lower weight and BMI and a greater percentage of excess weight loss than did the LAGB patients. Weight loss failure (BMI >35 kg/m(2) at 5 yr) was observed in 9 (34.6%) of 26 LAGB patients and in 1 (4.2%) of 24 LRYGB patients (P <.001). Of the 26 patients in the LAGB group and 24 in the LRYGB group, 3 (11.5%) and 15 (62.5%) had a BMI of <30 kg/m(2), respectively (P <.001).\n The results of our study have shown that LRYGB results in better weight loss and a reduced number of failures compared with LAGB, despite the significantly longer operative time and life-threatening complications.", "One of the main goals of weight reduction in morbidly obese subjects is its benefit on coronary heart disease (CHD) risk. A cross-sectional study was designed to randomly assign 79 morbidly obese subjects (27 men and 52 women; age: 30-45 years) either to a diet protocol (20 kcal per kg fat-free mass (FFM); 55% carbohydrates, 30% fat, and 15% proteins) or to malabsorptive surgery (biliopancreatic diversion). Fatness parameters, measured by dual-energy X-ray absorptiometry, lipid profile, insulin, leptin, sex steroid hormones and sex hormone-binding globulin (SHBG) levels were compared at baseline and 1 year after the beginning of the study. The data showed that plasma SHBG levels, but not testosterone levels, correlated negatively to fasting insulin levels and positively to HDL-cholesterol in both men and women. Total leptin levels were significantly lower (P<0.0001) in post-BPD subjects of both sexes compared to dietary treated obese subjects. The logarithm of plasma leptin correlated significantly and positively with insulin but negatively with SHBG.A step-down regression analysis showed that FFM and SHBG, but not insulin levels, were the most powerful independent variables for predicting HDL-cholesterol levels in morbidly obese patients. The negative relationship between SHBG levels and CHD risk appears to be mediated by a concomitant variation in body fatness. Finally, in obese patients, SHBG levels seem to be an indicator of total adiposity rather than an index of an altered insulin/glucose homeostasis.", "Banded gastric bypass has been reported to result in superior weight loss compared with standard nonbanded gastric bypass. However, an adequate comparison of these procedures has not yet been reported.\n A total of 90 patients were enrolled in this prospective randomized double-blind trial comparing banded and nonbanded open gastric bypass for the treatment of super obesity. The banding technique involved placement of a 1.5 x 5.5-cm polypropylene band around the proximal gastric pouch of a standard gastric bypass procedure using the technique of Capella. Chi-square testing and analysis of variance were performed to find any differences in patient characteristics (gender, age, and initial body mass index), percentage of excess weight lost at 6, 12, 24, and 36 months postoperatively, improvement or resolution of co-morbidities, and complications in the banded versus nonbanded gastric bypass groups.\n As expected, no differences were present in the patient characteristics or incidence of co-morbidities between the banded (n = 46) and nonbanded (n = 44) groups. The body mass index, percentage of women, and mean age was 59.5 and 56.5 kg/m2, 64% and 73.8% (P = .09), and 40.6 +/- 7.4 and 42.6 +/- 7.2 years for the banded and nonbanded groups, respectively; all differences were nonsignificant. No significant differences were found in the resolution of co-morbidities. No significant difference was present in the percentage of excess weight loss at 6, 12, and 24 months (43.1% versus 24.7%, 64.0% versus 57.4%, and 64.2% versus 57.2%, respectively) postoperatively; however, the banded patients had achieved a significantly greater percentage of excess weight loss at 36 months (73.4% versus 57.7%; P <.05). The incidence of intolerance to meat and bread was greater in the banded patients. The overall number of complications was 12 (26%) in the banded and 13 (29.5%) in the nonbanded group, a nonsignficant difference. No band erosions had occurred at the last follow-up visit, and no patients in either group died.\n These results suggest that although the initial weight loss was not significantly different between the 2 groups, the banded patients continued to lose weight for < or = 3 years. The polypropylene band appeared to be well tolerated. We plan longer follow-up to confirm the possibility of additional weight loss and the prevention of weight regain in the banded group, as well as to document any long-term band complications.", "Laparoscopic techniques have been developed for performing Roux-en-Y gastric bypass (LRYGBP) and vertical banded gastroplasty (LVBG) in patients with morbid obesity. It is not certain, however, which is the better technique in non-superobese patients (body mass index less than 50 kg/m(2)).\n Eighty-three patients (LRYGBP 37, LVBG 46) were assessed in a randomized clinical trial. Perioperative complications were recorded together with preoperative and postoperative respiratory function and mobilization rate. Patients were monitored for 2 years after operation with regard to weight change and the need for remedial surgery.\n There were no conversions to open surgery. The mean operating time was longer for LRYGBP than LVBG (138 versus 105 min). Five early reoperations were performed after LRYGBP (three for haemorrhage, one for ileus and one suspected leak) and one after LVBG (suspected leak). There were no differences in postoperative respiratory function or mobilization. Weight reduction was greater after LRYGBP (excess weight loss 78.3 versus 62.9 per cent 1 year after surgery, P = 0.009; 84.4 versus 59.8 per cent at 2 years, P < 0.001). Remedial surgical intervention was required in eight patients after LVBG (conversion to Roux-en-Ygastric bypass) and none after LRYGBP.\n LRYGBP and LVBG were comparable in terms of operative safety and postoperative recovery, but weight reduction was better after LRYGBP.\n Copyright (c) 2005 British Journal of Surgery Society Ltd. Published by John Wiley & Sons, Ltd.", "Ghrelin is an enteric peptide with strong orexigenic and adipogenic effects. Plasma ghrelin levels are decreased in obese subjects but increase after weight loss; this increase is not observed after Roux-en-Y gastric bypass (RYGB). Prospective and comparative data after adjustable silicone gastric banding (ASGB) have not been reported previously.\n Overnight fasting plasma ghrelin concentration was measured in morbidly obese subjects at baseline and 3, 6, 12, and 24 months after ASGB (n = 8) or RYGB (n = 5) and in nonoperated controls (n = 7).\n After RYGB, body weight (BW) decreased by 29.5 +/- 5.5 kg (mean +/- SE, p < 0.001), whereas plasma ghrelin failed to increase significantly (+167 +/- 119 pg/mL, not significant). In contrast, after ASGB, BW decreased less (by 22.8 +/- 5.9 kg; p < 0.001), and plasma ghrelin significantly increased by 377 +/- 201 pg/mL (p = 0.025). Neither BW nor plasma ghrelin changed in nonoperated controls. Plasma leptin decreased in both operated groups (similarly p < 0.05) but not in nonoperated controls. Plasma growth hormone and insulin-like growth factor 1 were not correlated with changes in plasma ghrelin concentrations.\n Plasma ghrelin levels failed to increase during substantial weight loss after RYGB, but did increase in response to lesser weight loss after ASGB. These findings suggest that the plasma ghrelin response after weight loss is impaired after exclusion of major parts of the stomach and the duodenum (RYGB), and the smaller long-term weight loss after ASGB compared with RYGB may be due, at least in part, to an absent increase in plasma ghrelin after RYGB.", "Morbidly obese patients show high somatic and psychiatric co-morbidity. Bariatric surgery is accepted as the obesity treatment with the greatest long-term success. There is growing evidence that follow-up studies should address somatic as well as psychosocial conditions of patients undergoing bariatric surgery and non-operatively treated patients. This study investigates the physical and psychosocial outcomes of patients with and without bariatric surgery.\n A sample of 131 morbidly obese patients applying for bariatric surgery underwent somatic and psychological assessment (T0). A first follow-up study (T1) was conducted 2 years after T0 in 119 patients. The present second follow-up (T2) was carried out 4 1/2 years after T0 and 3.2 years after potential bariatric surgery. Psychological/psychosocial measures were collected in the 93 patients, 63 of whom were treated surgically, via the Psychosocial Stress and Symptom Questionnaire (PSSQ) and a telephone interview covering BMI, employability, medication, doctor consultations, eating behavior, and physical/psychological well-being.\n Patients with and without bariatric surgery showed a BMI reduction, which was significantly greater in those who underwent surgery (P<.001). The average percentage of excess weight loss (%EWL) between T0 and T2 was 11.5% in patients with no bariatric surgery, 36.0% in patients with laparoscopic gastric banding, and 52.8% in patients with laparoscopic gastric bypass (%EWL between T0 and T2 in patients of all groups significant, P<.001). Patients with and without surgical treatment showed significant improvement with regard to depressive symptoms and binge-eating behavior. Three-quarters of the surgically-treated and two-thirds of the non-treated patients rated their physical, psychological, and psychosocial well-being as \"good\" at T2.\n After 3 to 4 years, all of the patients have adapted well to their weight and body appearance, regardless of whether they have undergone surgery. Weight loss is, however, greater for operated patients, which strongly decreases the risk of developing obesity-related co-morbidities.", "To compare the clinical results of adjustable gastric banding and vertical banded gastroplasty for morbid obesity.\n Prospective randomised trial.\n University hospital, Sweden.\n 59 morbidly obese patients, listed for obesity surgery.\n Adjustable gastric banding (n = 29) or vertical banded gastroplasty (n = 30).\n Weight loss, complications, need for revisional surgery, reflux symptoms and the patient's own evaluation.\n Five years after surgery the mean (SEM) weight reduction for adjustable gastric banding was 43 (3.0) kg and for vertical banded gastroplasty 35 (4.8) kg. One patient in each group died of unrelated causes during follow-up and 3 and 2 patients, respectively, were lost to follow-up. One patient in the vertical banded group required reoperation for an anastomotic leak on the third postoperative day. A total of 3 patients in the adjustable group required reoperation and 11 in the vertical banded group.\n Adjustable gastric banding carries a smaller risk of reoperation than vertical banded gastroplasty and the weight reduction is in the same order of magnitude.", "BACKGROUND: a prospective randomized study was undertaken to compare the outcome of vertical banded gastroplasty (VBG) and gastric bypass (GBP) in patients with clinically severe obesity. METHODS: eligibility criteria included Class IV obesity, < 50 years old and a history of at least one attempt of non-operative weight loss. Patients were managed conservatively for 3 months prior to surgery. Patients were followed post-operatively and monitored for early and late complications and their weight loss outcome for up to 5 years. RESULTS: 44 patients were recruited. Two patients withdrew within 4 weeks and were excluded. Twenty subjects had a GBP and 22 a VBG. There were no significant differences with respect to age, gender, maximum or pre-operative weight between the groups (p > 0.05). Patients who underwent GBP demonstrated significantly greater post-operative weight loss (p < 0.05) which was apparent from 6 months onwards. There were no deaths, pulmonary emboli, post-operative leaks or wound dehiscence. There were no instances of staple-line disruption. Symptomatic ulcer disease, confirmed endoscopically, developed in 25% of GBP patients. Nine patients developed gallstones post-operatively of whom five were in the VBG and four in the GBP group. CONCLUSIONS: weight loss following GBP was maintained, while VBG patients slowly regained.", "Bariatric surgery improves cardiovascular risk factors and quality of life, but few studies have directly addressed the relation between obesity treatment and hospitalization costs. This prospective controlled study compares in-patient care between surgically and conventionally treated obese patients.\n A total of 962 surgically and conventionally treated obese patients from the intervention study, Swedish Obese Subjects, were followed for 6 years. Changes in days of hospitalization and hospitalization costs were analyzed. Information on hospitalizations for each subject were obtained from the Swedish Hospital Discharge Register.\n After 6 years, weight change was -16.7% in the surgical group and +0.9% in the control group (p < 0.0001). The cumulated hospital stay over 6 years was 23.4 days in the surgical group and 6.9 days in the control group (p < 0.0001). The average hospital cost for the surgical intervention was US$4300. Incremental costs that could be attributable to obesity surgery averaged US$1200 per year. After exclusion of hospitalizations for the surgical intervention and conditions common after bariatric surgery, there were no significant differences between the groups in number of hospital days or hospitalization costs.\n Our experience from bariatric surgery indicates that average weight reductions of 16% will not reduce hospitalization costs over 6 years. Costs of bariatric surgery are limited and seem to be motivated given the marked improvements of cardiovascular risk factors, cardiac structure, and function and health-related quality of life.", "Vertical banded gastroplasty (VBGP) was compared with Roux-en-Y gastric bypass (RYGBP) in a randomized prospective trial that included preoperative dietary separation of \"sweets eaters\" versus \"non-sweets eaters.\" Randomization was stopped at 9 months after 20 patients had undergone each procedure because a greater weight loss (p less than 0.05) was noted after RYGBP than VBGP. This difference became more significant (p less than 0.001) at each 3-month interval through 3 years, when patients who had VBGPs had lost 37 +/- 20% of excess weight compared with 64 +/- 19% for patients who had RYGBPs. The members of the groups were comparable with regard to age, sex, eating habits, morbidity rates before surgery, ideal body weight, and weight before surgery. Although there was no significant difference between the loss of excess weight in \"sweets eaters\" (69 +/- 17%) or \"non-sweets eaters\" (67 +/- 17%) after RYGBP at 1 year, \"sweets eaters\" who had VBGPs lost significantly less excess weight (36 +/- 13%) than did \"non-sweets eaters\" who had VBGPs (57 +/- 18%), p less than 0.02, or \"sweets eaters\" who had RYGBPs, p less than 0.0001. No significant differences were noted for electrolytes, renal or liver function tests, and most vitamins between patients who had VBGPs and RYGBPs; however, patients who had RYGBPs had lower (p less than 0.05) serum vitamin B12 levels (286 +/- 149 pg/dl) than did patients who had VBGPs (461 +/- 226 pg/dl) at 2 years. By 3 years, the vitamin B12 levels were equal in members of the two groups. Five patients who had RYGBPs required endoscopic stomal dilatation for stomal stenosis and one had a marginal ulcer develop, which responded to cimetidine. RYGBP was clearly superior to VBGP for \"sweets eaters,\" probably because of the development of dumping syndrome symptoms. However, RYGBP was associated with a larger number of correctable problems. Thus, it is important to evaluate a patient's eating habits before surgery for morbid obesity; \"non-sweets eaters\" probably should be treated with VBGP and \"sweets eaters\" with RYGBP.", "Bariatric surgery is currently the most effective treatment in morbidly obese patients, leading to durable weight loss.\n In this prospective double blind study, we aim to evaluate and compare the effects of laparoscopic Roux-en-Y gastric bypass (LRYGBP) with laparoscopic sleeve gastrectomy (LSG) on body weight, appetite, fasting, and postprandial ghrelin and peptide-YY (PYY) levels.\n After randomization, 16 patients were assigned to LRYGBP and 16 patients to LSG. Patients were reevaluated on the 1st, 3rd, 6th, and 12th postoperative month. Blood samples were collected after an overnight fast and in 6 patients in each group after a standard 420 kcal mixed meal.\n Body weight and body mass index (BMI) decreased markedly (P < 0.0001) and comparably after either procedure. Excess weight loss was greater after LSG at 6 months (55.5% +/- 7.6% vs. 50.2% +/- 6.5%, P = 0.04) and 12 months (69.7% +/- 14.6% vs. 60.5% +/- 10.7%, [P = 0.05]). After LRYGBP fasting ghrelin levels did not change significantly compared with baseline (P = 0.19) and did not decrease significantly after the test meal. On the other hand, LSG was followed by a marked reduction in fasting ghrelin levels (P < 0.0001) and a significant suppression after the meal. Fasting PYY levels increased after either surgical procedure (P < or = 0.001). Appetite decreased in both groups but to a greater extend after LSG.\n PYY levels increased similarly after either procedure. The markedly reduced ghrelin levels in addition to increased PYY levels after LSG, are associated with greater appetite suppression and excess weight loss compared with LRYGBP.", "The objective of the study was to compare the results of open versus laparoscopic gastric bypass in the treatment of morbid obesity.\n Gastric bypass is one of the most commonly acknowledged surgical techniques for the management of morbid obesity. It is usually performed as an open surgery procedure, although now some groups perform it via the laparoscopic approach.\n Between June 1999 and January 2002 we conducted a randomized prospective study in 104 patients diagnosed with morbid obesity. The patients were divided into 2 groups: 1 group with gastric bypass via the open approach (OGBP) comprising 51 patients, and 1 group with gastric bypass via the laparoscopic approach (LGBP) comprising 53 patients. The parameters compared were as follows: operating time, intraoperative complications, early (<30 days) and late (>30 days) postoperative complications, hospital stay, and short-term evolution of body mass index.\n Mean operating time was 186.4 minutes (125-290) in the LGBP group and 201.7 minutes (129-310) in the OGBP group (P < 0.05). Conversion to laparotomy was necessary in 8% of the LGBP patients. Early postoperative complications (<30 days) occurred in 22.6% of the LGBP group compared with 29.4% of the OGBP group, with no significant differences. Late complications (>30 days) occurred in 11% of the LGBP group compared with 24% of the OGBP group (P < 0.05). The differences observed between the 2 groups are the result of a high incidence of abdominal wall hernias in the OGBP group. Mean hospital stay was 5.2 days (1-13) in the LGBP group and 7.9 days (2-28) in the OGBP group (P < 0.05). Evolution of body mass index during a mean follow-up of 23 months was similar in both groups.\n LGBP is a good surgical technique for the management of morbid obesity and has clear advantages over OGBP, such as a reduction in abdominal wall complications and a shorter hospital stay. The midterm weight loss is similar with both techniques. One inconvenience is that LGBP has a more complex learning curve than other advanced laparoscopic techniques, which may be associated with an increase in postoperative complications.", ": Roux-en-Y gastric bypass (RYGBP) has increased in popularity since the introduction of the laparoscopic procedure, but this approach requires extensive surgical skill and the learning curve is steep. The present study examined the suitability of hand-assisted laparoscopy for RYGBP.\n In a prospective trial, 50 patients (median age 38 years, body mass index 45 kg/m(2)) were randomized to either hand-assisted (n = 25) or open (n = 25) RYGBP. The hand-assisted device was introduced through a right subcostal incision. Laparoscopic staplers were also used in the open group, allowing a short upper midline incision. The gastrojejunostomy was made by means of a circular stapler and the Roux limb placed behind the colon and excluded stomach.\n The postoperative outcome, with respect to morphine consumption, complications, hospital stay (6 days) and weight loss, was similar in the two groups. The operating time was significantly longer in the hand-assisted group (150 versus 85 min; P < 0.001) but there was no conversion to open operation. One patient in the hand-assisted group was reoperated owing to leakage and one patient developed an incisional hernia after open RYGBP.\n The hand-assisted technique was feasible and allowed good working conditions in all patients. However, the postoperative outcome was excellent in both groups and there was no advantage to the hand-assisted technique.\n Copyright 2004 British Journal of Surgery Society Ltd.", "BACKGROUND: A prospective, randomized trial comparing vertical banded gastroplasty (VBG) and gastric bypass (GB) was performed on 106 patients between 1987 and 1990. METHODS AND RESULTS: Failures of these two operations (manifested by failure to lose weight, late weight gain or intolerance of adequate oral intake) were treated by means of a third operation, isolated gastric bypass (IGB), in which the small gastric pouch was isolated from the gastric fundus. The latter operation was significantly better than VBG or GB and achieved a 63% success rate, i.e. body mass index (BMI) < 35 kg m(2) and less than 50% excess weight. During the year following this trial an additional 54 patients underwent IGB. When this operation was performed for morbid obesity and was the Initial procedure, 96% of the patients achieved a successful result. If IGB was performed as a revision procedure or for super obesity (BMI > 50 kg m(2)), the success rate was 63% with 100% follow-up at 40 months. Major morbidity occurred in six of the 160 patients who underwent 195 operations (the trial period and subsequent year). There were no deaths and follow-up was 98%. CONCLUSIONS: The ideal gastric operation based on this study emphasizes the following requirements: a small pouch (< 15 ml) totally separated from the stomach, a pouch not dependent on staples, placed in the dependent position to prevent stasis, constructed without foreign material and with an anastomosis which permits ingestion of solid food.", "Laparoscopic adjustable gastric banding (GB) is the most popular restrictive procedure for obesity in Europe. Isolated sleeve gastrectomy (SG), is less common, but more invasive and with a higher learning curve. The aim of this prospective randomized study was to compare the results of GB and SG after 1 and 3 years of surgery.\n 80 patient candidates for laparoscopic restrictive surgery were operated consecutively and randomly, between January and December 31, 2002, by GB (7M, 33F) or by SG (9M, 31F) (NS). Median age was 36 (20-61) for GB versus 40 (22-65) for SG (NS). Median BMI was 37 (30-47) for GB versus 39 (30-53) for SG (NS). After 1 and 3 years: weight loss, feeling of hunger, sweet eating, gastroesophageal reflux disease (GERD), complications and re-operations were recorded in both groups.\n Median weight loss after 1 year was 14 kg (-5 to +38) for GB and 26 kg (0 to 46) for SG (P<0.0001); and after 3 years was 17 kg (0 to 40) for GB and 29.5 kg (1 to 48) for SG (P<0.0001). Median decrease in BMI after 1 year was 15.5 kg/m 2 (5 to 39) after GB and 25 kg/m(2) (0 to 45) after SG (P<0.0001); and after 3 years was 18 kg/m(2) (0 to 39) after GB and 27.5 kg/m 2 (0 to 48) after SG (P=0.0004). Median %EWL at 1 year was 41.4% (-11.8 to +130.5) after GB and 57.7% (0 to 125.5) after SG (P=0.0004); and at 3 years was 48% (0 to 124.8) after GB and 66% (-3.1 to +152.4) after SG (P=0.0025). Loss of feeling of hunger after 1 year was registered in 42.5% of patients with GB and in 75% of patients with SG (P=0.003); and after 3 years in 2.9% of patients with GB and 46.7% of patients with SG (P<0.0001). Loss of craving for sweets after 1 year was achieved in 35% of patients with GB and 50% of patients with SG (NS); and after 3 years in 2.9% of patients with GB and 23% of patients with SG (NS). GERD appeared de novo after 1 year in 8.8% of patients with GB and 21.8% of patients with SG (NS); and after 3 years in 20.5% of patients with GB and 3.1% of patients with SG (NS). Postoperative complications requiring re-operation were necessary for 2 patients after SG. Late complications requiring re-operation after GB included 3 pouch dilations treated by band removal in 2 and 1 laparoscopic conversion to Roux-en-Y gastric bypass (RYGBP), 1 gastric erosion treated by conversion to RYGBP, and 3 disconnections of the system treated by reconnection. Inefficacy affected 2 patients after GB, treated by conversion into RYGBP and 2 patients after SG treated by conversion to duodenal switch.\n Weight loss and loss of feeling of hunger after 1 year and 3 years are better after SG than GB. GERD is more frequent at 1 year after SG and at 3 years after GB. The number of re-operations is important in both groups, but the severity of complications appears higher in SG.", "The feasibility of laparoscopic Roux-en-Y gastric bypass (Lap-RYGBP) for morbid obesity is well documented. In a prospective randomized trial, we compared laparoscopic and open surgery.\n 51 patients (48 females, mean (+/- SD) age 36 +/- 9 years and BMI 42 +/- 4 kg/m2) were randomly allocated to either laparoscopy (n = 30) or open surgery (n = 21). All patients were followed for a minimum of 1 year.\n In the laparoscopy group, 7 patients (23%) were converted to open surgery due to various procedural difficulties. In an analysis, with the converted patients excluded, the morphine doses used postoperatively were significantly (p < 0.005) lower in the laparoscopic group compared to the open group. Likewise, postoperative hospital stay was shorter (4 vs 6 days, p < 0.025). Six patients in the laparoscopy group had to be re-operated due to Roux-limb obstruction in the mesocolic tunnel within 5 weeks. The weight loss expressed in decrease in mean BMI units after 1 year was 14 +/- 3 and 13 +/- 3 after laparoscopy and open surgery, respectively (not significant).\n Both laparoscopic and open RYGBP are effective and well received surgical procedures in morbid obesity. Reduced postoperative pain, shorter hospital stay and shorter sick-leave are obvious benefits of laparoscopy but conversions and/or reoperations in 1/4 of the patients indicate that Lap-RYGBP at present must be considered an investigational procedure.", "Vertical banded gastroplasty (VBG) and gastric bypass (GBP) are the two bariatric procedures recommended by NIH consensus conference. Recent advancement in laparoscopic (L) techniques has made LVBG and LGBP alternatives for the conventional open approach.\n From December 2000 to February 2002, 80 patients (24 men and 56 women; mean age 32 years, range 18-57) with morbid obesity (mean BMI 43.2 kg/m(2), range 36-59.8) were enrolled in a prospective trial and randomly assigned to LVBG or LGBP. Changes in quality of life were assessed using the Gastro-intestinal quality of life index (GIQLI).\n The conversion rate was zero for LVBG and 2.5% (1/40) for LGBP. There has been no mortality. Surgical time was significantly longer for LGBP (209 minvs 126 min for LVBG, P<0.001). Mean hospital stay was 3.5 days for the LVBG vs 5.7 days for LGBP (P<0.001). Postoperative analgesic usage was also less for LVBG patients (mean dose 1.4 vs 2.4, P<0.05). Early complication rate was higher in the LGBP group (17.8% vs 2.5%, P<0.001). All 3 major complications were in the LGBP group, of which 2 were related to anastomotic leakage (5%). Late complications consisted of upper GI bleeding, stenosis and others observed in 4 LGBP patients (10%) and 2 LVBG patients (5%). Mean follow-up was 20 months (range 18 to 30). BMI fell significantly in both groups, with significant improvement of obesity-related co-morbidities. LGBP had significantly better excess weight loss than LVBG (62.9% vs 55.4% at 1 year and 71.4% vs 53.1% at 2 years), as well as lower BMI than LVBG (29.6 vs 31.1 at 1 year and 28.5 vs 31.9 at 2 years). There was no difference in the reduction of obesity-related laboratory abnormalities at 1 year except a lower hemoglobin in LGBP (11.8 vs 13.8, P<0.05). Preoperative GIQLI scores were similar between the groups; however, at 1 year, LGBP patients had better GIOLI scores than LVBG patients (121 vs 106, P<0.01). LVBG had improvement in physical condition, social function and emotional conditioning but deterioration in GI symptoms which resulted in no increase in total GIQLI score.\n LGBP was a time-consuming demanding technique with a higher early complication rate compared with LVBG. Although both operations resulted in significant weight reduction and decrease in obesity-related co-morbidities, LGBP had a trend of greater weight loss and significantly better GIQLI than LVBG at the cost of a significant long-term trace element deficiency state. Each patient should be individualized for the operations according to the patient's decision.", "Vertical banded gastroplasty (VBG) is a frequently used surgical procedure for the treatment of morbid obesity. It can be done open (OVBG) or laparoscopic (LVBG). The aim of this double-blind randomized clinical trial was to compare the postoperative outcome and 1-year follow-up of 2 cohorts of patients who underwent either OVBG or LVBG.\n 30 patients with morbid obesity were randomized into 2 groups (14 OVBG and 16 LVBG). Pain intensity, analgesic requirements, respiratory function, and physical activity were blindly analyzed during the first 3 postoperative days. Complications, weight loss, and cosmetic results after 1 year follow-up were evaluated.\n Both groups were highly comparable before surgery. Surgical time was longer in the laparoscopic procedure. Patients in this group required less analgesics during the first postoperative day. There was an earlier recovery in the expiratory and inspiratory forces, as well as faster recovery of physical activities in patients who underwent LVBG. Postoperative complications were more frequent in the open group. Excess body weight loss after 1 year was similar in both groups. Cosmetic results were significantly better in the laparoscopic group.\n LVBG had advantages over the open procedure in terms of analgesic requirements, respiratory function, postoperative recovery, and cosmetic results.", "To compare, in a prospective, randomized, single-institution trial laparoscopic adjustable silicone gastric banding (LASGB) with laparoscopic vertical banded gastroplasty (LVBG) in morbidly obese patients.\n LASGB is a simple and safe procedure, but some reports have suggested disappointing long-term results. Despite the recent widespread use of LASGB, there are no prospective nor randomized trials comparing LASGB with other laparoscopic procedures.\n A total of 100 morbidly obese patients, with body mass index (BMI) 40 to 50 kg/m2, without compulsive eating, were randomized to either LASGB (n = 49) or LVBG (n = 51). Minimum follow-up was 2 years (mean 33.1 months).\n There were no deaths or conversions in either group. Mean operative time was 94.2 minutes in LVBGs and 65.4 in LASGBs (P < 0.05). Early morbidity rate was lower in LASGBs (6.1%) versus LVBGs (9.8%) (P = 0.754). Mean hospital stay was shorter in LASGBs versus LVBGs: 3.7 days versus 6.6 (P < 0.05). Late complications rate in LVBGs was 14% (7 of 50) and in LASGBs 32.7% (16 of 49) (P < 0.05). The most frequent complication was the slippage of the band (18%). Late reoperations rate in LVBGs was 0% (0 of 50) versus 24.5% (12 of 49) in LASGBs (P < 0.001). Excess weight loss in LVBGs was, at 2 years, 63.5% and, at 3 years, 58.9%; in LASGBs, excess weight loss, respectively, was 41.4% and 39%. BMI in LVBGs was, at 2 years, 29.7 kg/m2 and, at 3 years, 30.7 kg/m2; in LASGBs, BMI was 34.8 kg/m2 at 2 years and 35.7 kg/m2 at 3 years. According to Reinhold's classification, a residual excess weight <50% was achieved, at 2 years, in 74% of LVBG and 35% of LASGB (P < 0.001).\n This study demonstrates that, in patients with BMI 40 to 50 kg/m2, LASGB requires shorter operative time and hospital stay but LVBG is more effective in terms of late complications, reoperations, and weight loss." ]

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[ "Effects of occupational therapy home service on patients with rheumatoid arthritis.", "Educating patients with rheumatoid arthritis: a prospective analysis.", "A controlled study of group counseling in rheumatoid arthritis.", "Stress management and mutual support groups in rheumatoid arthritis.", "A randomized controlled trial to evaluate the efficacy of community based physical therapy in the treatment of people with rheumatoid arthritis.", "Positive impact of an intervention by arthritis patient educators on knowledge and satisfaction of patients in a rheumatology practice.", "Home exercise in rheumatoid arthritis functional class II: goal setting versus pain attention.", "A 12-month randomized controlled trial of patient education on radiographic changes and quality of life in early rheumatoid arthritis.", "Group therapies for rheumatoid arthritis. A controlled study of two approaches.", "Cognitive-behavioral treatment in unselected rheumatoid arthritis outpatients.", "Single-blind randomized controlled trial of an educational booklet for patients with chronic arthritis.", "Effect of patient education on adherence to drug treatment for rheumatoid arthritis: a randomised controlled trial.", "A randomized controlled study of the Arthritis Self-Management Programme in the UK.", "Evaluation of a computer based education lesson for patients with rheumatoid arthritis.", "Preoperative education for total hip and knee replacement patients.", "Effects of psychological therapy on pain behavior of rheumatoid arthritis patients. Treatment outcome and six-month followup.", "A blind, randomized, controlled trial of cognitive-behavioural intervention for patients with recent onset rheumatoid arthritis: preventing psychological and physical morbidity.", "Promoting self-care in clients with arthritis.", "Outcomes of self-help education for patients with arthritis.", "A comparison of lay-taught and professional-taught arthritis self-management courses.", "Persistent functional and social benefit 5 years after a multidisciplinary arthritis training program.", "The effect of person-centered counseling on the psychological status of persons with systemic lupus erythematosus or rheumatoid arthritis: a randomized, controlled trial.", "Health outcomes of two telephone interventions for patients with rheumatoid arthritis or osteoarthritis.", "[Psychological treatment approaches in pain. A comparative study of therapies in patients with chronic polyarthritis].", "A cognitive-behavioral treatment for rheumatoid arthritis.", "A crossover trial evaluating an educational-behavioural joint protection programme for people with rheumatoid arthritis.", "A reexamination of the effectiveness of self-care education for persons with arthritis.", "Pain management in rheumatoid arthritis patients. A cognitive-behavioral approach.", "Effectiveness of self-instruction for arthritis patient education.", "Patient education in arthritis: randomized controlled trial of a mail-delivered program.", "A problem-based education program for patients with rheumatoid arthritis: evaluation after three and twelve months.", "Community-based Spanish language arthritis education program: a randomized trial.", "Evidence suggesting that a chronic disease self-management program can improve health status while reducing hospitalization: a randomized trial.", "Effects of stress management on clinical outcomes in rheumatoid arthritis." ]

[ "Because there is little information about the efficacy of home occupational therapy, we decided to assess the effects of a home service on patients with rheumatoid arthritis. 105 patients aged 18-70 years, on stable medical therapy, were randomised to receive a 6-week comprehensive programme of occupational therapy (experimental group, 53 patients) or to receive no such treatment (control group, 52). At 6 weeks, control patients received the experimental regimen, and experimental patients were continued on treatment as needed up to 12 weeks. Outcomes were measured at baseline, 6, and 12 weeks with a global functional capacity score (functional score). At 6 weeks the functional score for the experimental group was significantly higher than that for the control group (mean difference = 8.1, 95% Cl 1.7 to 15.8, p = 0.012). Control patients at 12 weeks showed a similar improvement to experimental patients at 6 weeks, and between 6 and 12 weeks the experimental patients were stable. Occupational therapy leads to a statistically significant and clinically important improvement in function in patients with rheumatoid arthritis.", "Twenty-two men with rheumatoid arthritis were randomly assigned to either a patient education group, receiving standard inpatient medical care in addition to a formal education program, or a control group receiving only the inpatient medical care. Members of the groups were not significantly different in terms of age, degree of life stress, socioeconomic status, educational level, or years since onset of rheumatoid arthritis. Dependent measures included the Arthritis Knowledge Inventory (AKI), the Arthritis Impact Measurement Scales (AIMS), and the Beck Depression Inventory (BDI), and they were collected preeducation, posteducation, and at a three-month followup. Results from the AIMS revealed improvement in dexterity, social role, depression, and overall health status for both groups. The BDI also revealed significantly less depression for both groups, reflecting a general improvement following medical intervention. Although the patient education group revealed significantly higher scores on the knowledge measure, they also revealed significantly more impairment of activity levels and significantly higher pain scores. Education was effective for increasing rheumatoid arthritis knowledge, but such topics as joint protection and disease process may adversely affect how patients view their physical capacities and interpret their pain.", "Group counseling and education were studied in patients with rheumatoid arthritis (RA). Patients were matched and randomly assigned to a control (CG) or experimental (EG) group. Each group attended an educational session but only the EG participated in 12 weekly group counseling sessions. A test of knowledge about RA and psychological tests were administered before and after these sessions. The EG improved their scores in 2 areas of self-concept and in factual knowledge. There was no increase in depression level. These results provide evidence that formal educational sessions and group counseling may be important in the management of patients with RA.", "Stress management and mutual support groups are employed widely in chronic illness, although their efficacy has not been established. To determine the effect of these measures on morbidity and psychologic health in rheumatoid arthritis, 105 patients meeting diagnostic criteria for rheumatoid arthritis were evaluated for depression, life satisfaction, functional disability, and indicators of disease activity. Patients were randomly assigned to one of three groups: (1) stress management; (2) mutual support; (3) no intervention (control). After completion of 10 weekly sessions, identical tests were performed for all patients in the intervention and control groups. Patients in the intervention groups showed greater improvement in joint tenderness than did the control patients but did not differ significantly from the patients in the control group in any of the other outcome measures.", "To evaluate the short term efficacy of a community based physical therapy (PT) program for people with rheumatoid arthritis (RA) through a single blind randomized controlled trial.\n Adults with active RA were referred by their physician for community based PT. Participants were randomized to either an immediate intervention group [experimental group (EG)] or a wait list control group (CG). The intervention was a standardized program of education and exercise consisting of at least 4 visits or 3 h of PT over 6 weeks. Baseline, 6, and 12 week assessments were by a blinded independent assessor. The primary outcome instrument was the Stanford Arthritis Self-Efficacy Scale (SES) and secondary outcome measures included the ACREU Rheumatoid Arthritis Knowledge Questionnaire (KQ) and visual analog scale for pain (VAS). Duration of morning stiffness, grip strength, and tender joint count were also collected at each assessment. Outcome analysis was conducted using analysis of variance.\n Of 150 eligible and randomized participants, 127 completed the study according to protocol. Baseline analysis showed no differences between the EG and CG for demographics, disease status, or other characteristics. At the 6 week assessment, primary outcome analysis for those who completed the protocol identified a mean change (improvement) of 13.5% in the EG and 5.8% in the CG, representing a 7.7% difference in change scores between the 2 groups [F(1,121) = 6.03; p = 0.015]. A statistically significant difference in change scores was also identified for the KQ [F(1,120) = 6.67; p = 0.011], but not for the VAS. Disease status measures did not change, except for duration of morning stiffness, which improved by 68.8 min in the EG and 8.3 min in the CG (F(1,121) = 4.50; p = 0.036].\n Four hours of a community based PT intervention delivered over 6 weeks significantly improved self-efficacy, disease management knowledge and morning stiffness in people with RA.", "The goal of the study was to determine whether an intervention by a trained arthritis patient educator could have a positive impact on the health status, knowledge, and satisfaction with services of arthritis patients attending an ambulatory rheumatology care clinic by providing education and support.\n One hundred eight arthritis patients were randomly assigned to have an intervention by an arthritis patient educator as well as standard rheumatologic care (n = 47) or were assigned to the control group receiving only standard rheumatologic care (n = 61). Both groups completed the Arthritis Impact Measurement Scales 2 and the Arthritis Self-Efficacy Scale at baseline arrival to the clinic. After the appointment with the rheumatologist, each patient of the study group met with an arthritis patient educator. This session included educational and social support. A week later this group of patients received a followup telephone call from an arthritis patient educator to determine whether the patient had unanswered questions or needed additional support. Eight weeks later, both groups completed the baseline questionnaire again, a basic arthritis knowledge test, and a satisfaction survey.\n Eight weeks after the interventions, basic knowledge scores, on a scale of 1 to 8, were significantly different for the study group and the control group (6.48 +/- 0.31 versus 5.35 +/- 0.35, respectively, P = 0.02). A greater percentage of patients who received the intervention by an arthritis patient educator was able to identify two of the educational resources available to them compared with patients in the control group (92.6 +/- 0.05% versus 64.50 +/- 0.08%, P = 0.015, 77.7 +/- 0.08% versus 54.8 +/- 0.09%, P = 0.041). A greater percentage of persons in the active intervention group was also able to identify one self-help aid compared with the control group (88.8 +/- 0.06% versus 67.74 +/- 0.08%, P = 0.028). Overall satisfaction with care was rated \"good\" or \"excellent\" more often by the study group when compared with the control group (88.5 +/- 0.24% versus 61.3 +/- 0.32%, P = 0.01). Of the study group, 69% found the session helpful, and 58% desired further interactions; 16% of the control group also requested future appointments with the arthritis patient educators.\n Arthritis patient educators can provide a meaningful and useful addition to traditional rheumatology care, positively affecting patient knowledge and satisfaction with clinic services.", "To evaluate the effects of a 12-week home exercise and cognitive treatment program in functionally independent patients with rheumatoid arthritis.\n Forty-two patients were assessed with the Arthritis Self-efficacy Scale, the Stanford Health Assessment Questionnaire, the Ritchie articular index, measurement of joint mobility, and registration of capacity and pain in functional tasks. The patients were then randomized to either a \"goal-setting\" subgroup, in which individual goals for the exercise were set and exercise encouraged despite pain, or to a \"pain attention\" subgroup, where advice to decrease exercise load in case of pain was given. All patients used the same home exercise program aiming at improved range of motion, muscle function and aerobic capacity.\n After the intervention period, exercise had conferred better self-efficacy for \"other symptoms,\" increased capacity in most functional tasks, decreased activity induced pain, lowered Ritchie index, and increased joint mobility. Some improvements regarding pain were larger in the goal-setting subgroup.\n Home exercise influences self-efficacy for mood and fatigue, physical capacity, and pain. Additional cognitive treatment seems to positively influence the perception of pain.", "In rheumatoid arthritis, education programmes successfully impart knowledge but, notwithstanding issues of empowerment, this knowledge has to be translated into behavioural change to have a chance of improving disease outcome. Arguably, behavioural change must also occur early if outcomes are to be improved. For these reasons, we planned a study of patient education in early disease, with radiological damage and quality of life as the main outcome variables.\n We performed a randomized controlled trial in people with rheumatoid arthritis of < 5 yr duration. The main intervention was a 4 week education programme, each weekly session lasting 2 h. Assessments were made at entry, at 4 weeks and at 12 months. The main outcome variables were the modified Larsen radiological score for the hands and the SF-36 quality of life questionnaire. Secondary outcome variables were the Health Assessment Questionnaire (HAQ), Ritchie Articular Index (RAI), Patient Knowledge Questionnaire (PKQ), Compliance Questionnaire (CQ), plasma viscosity (PV), pharmaceutical changes and consulting behaviour.\n The patient numbers were 34 (10 male, 24 female) for the control group and 43 (16 male, 27 female) for the education group. The groups were matched for age (56.5 yr for control, 55 yr for education), disease duration (3.5 yr vs 3.0 yr) and duration of second-line drug therapy (14 months vs 12 months). We found no significant difference between the groups for Larsen scores at 12 months, although scores for the education group were lower (39.5 vs 43.0, P = 0.13). The 'social functioning' and 'general health perception' subscales of the SF-36 showed a significant improvement in the education group, but no significant differences between groups were seen. No significant differences were found for the HAQ, RAI, PV and CQ, but the education group had more disease-specific knowledge than the control group at 12 months (PKQ scores: 17 vs 21, P = 0.0002). No differences were found for out-patient visits and in-patient admissions, but the education group had slightly more changes in second-line drugs during the study (0.43 changes/person in the control group, 0.51 changes/person in the education group).\n We found no significant difference between the groups in our primary outcome measures, but a trend in favour of the education group was found in radiological progression. Further studies of this kind, using larger patient numbers, are required since the difference may result from improved self-care, better compliance with joint protection strategies and, possibly, improved drug compliance.", "An important unanswered question about rheumatoid arthritis (RA) is how the patient's psychological or emotional state relates to disease activity and functional status. No controlled studies of psychotherapeutic interventions in RA have been reported. To test the hypothesis that a psychosocial intervention would lead to improvement in functional status or disease activity, 57 RA patients were randomly assigned to 1 of 3 groups, which received: 1) conventional group psychotherapy; 2) group assertion/relaxation training; or 3) no treatment (control group). Patient and physician questionnaires collected at baseline, immediately after the interventions, and 12 months after baseline provided outcome data on functional status, social and psychological adaptation, psychological symptoms, and disease activity. There were few outcome measures for which either treatment resulted in significantly higher scores than were seen in controls, though more improvement did occur among patients who received conventional group psychotherapy.", "This trial was performed to evaluate the efficacy of an adjunctive cognitive-behavioral treatment compared with rheumatological treatment alone in unselected rheumatoid arthritis outpatients.\n A prospective randomized control design was used. Change in medication during treatment was controlled by matching therapy- and control-group subjects according to this change in medication, sex, age, duration of disease, and functional class.\n A rheumatological outpatient clinic, University of Goettingen, Germany.\n Fifty-five consecutive outpatients with a diagnosis of rheumatoid arthritis (age 52.7 years, 74.5% female, duration of disease 9.4 years) finished the study.\n Subjects received routine care by the rheumatologists and routine medical treatment. Cognitive-behavioral treatment subjects (n = 19) received adjunctive standardized cognitive-behavioral group treatment with 12 weekly sessions.\n Outcome measures included disease activity variables, pain variables (pain intensity, affective pain), psychological symptoms, and coping.\n Subjects mostly demonstrated an increasing disease activity during treatment; change in medication during treatment was necessary in some patients. In the cognitive-behavioral treatment group the course of rheumatoid arthritis seemed less progressive than in the control group. The core effects of cognitive-behavioral treatment pertain more to improved coping, emotional stabilization, and reduced impairment than to reduced pain intensity. Passive, emotion-focused coping, helplessness, depression, anxiety, affective pain, and fluctuation of pain are reduced, \"Acceptance of Illness\" is improved.\n Cognitive-behavioral therapy has proven an effective adjunct to standard treatment of rheumatoid arthritis outpatients. These effects were shown in an unselected sample with increasing disease activity and with comparable changes in medication during treatment. We recommend cognitive-behavioral treatment as an desirable adjunct to standard medical treatment of rheumatoid arthritis.", "Consecutive new attendees at a rheumatology clinic were randomly allocated to one of three groups. All groups received routine care, but one received no other intervention, one an educational booklet on arthritis and one the booklet plus instruction from a health professional. Prior to intervention, all groups had similar knowledge. Nottingham Health Profile (NHP) and Health Assessment Questionnaire (HAQ) score. After 6 weeks, the knowledge score was significantly increased in both groups given the booklet, but not in the control group. The group instructed by a health professional showed no greater increase than the group given the booklet alone. Increased knowledge was not associated with improved clinical status and no group showed a significant change in NHP or HAQ scores. Nearly all patients said they found the booklet useful.", "To determine whether a patient education programme (PE) would improve rates of adherence to a slow acting antirheumatic drug and to assess any subsequent effect on patient outcome.\n A randomly controlled study comprising 100 patients with rheumatoid arthritis (49 control CG; 51 experimental EG) requiring D-penicillamine (DPA). The same practitioner saw patients on seven occasions, for the same length of time. The EG received 7 x 30 minute one to one sessions of PE, while the CG received standard management. The primary measure of adherence was a pharmacological marker (phenobarbitone) encapsulated with the DPA assayed at monthly intervals for six months. Plasma viscosity (PV), C reactive protein, articular index, morning stiffness, and pain score were used to assess outcome.\n 454 blood samples were collected and assayed and the pharmacological marker showed the EG to be significantly more adherent on more occasions than the CG (p<0.05). Patterns of adherence over time showed that at 12 weeks 86% (38/44) of those in the EG compared with 64% (29/45) of the CG remained adherent (p=0.01). These trends continued and by the end of the study 85% (29/34) of the EG compared with 55% (23/42) of the CG were taking their DPA as prescribed. Fifteen patients (12 from the EG) experienced side effects requiring study withdrawal and 14 patients requested study withdrawal (two from the EG). On study entry patients in the CG had significantly higher levels of PV than the EG and this remained so throughout the research. However, on completion, the health status of patients in both groups had improved significantly (p<0.01).\n PE significantly increased adherence to DPA and its effects persisted over a period of six months. No additional clinical benefit was detected in the EG in comparison with the CG.", "The objective of this study was to determine whether the Arthritis Self-Management Programme (ASMP) improves perceptions of control, health behaviours and health status, and changes use of health care resources. The design was a pragmatic randomized controlled study; participants were allocated to ASMP (Intervention Group) or a 4-month waiting-list Control Group. The Intervention Group completed a 12-month follow-up. In total, 544 people with arthritis were recruited from the community--311 in the Intervention Group and 233 in the Control Group. Main outcome measures included: arthritis self-efficacy, health behaviours (exercise, cognitive symptom management, diet and relaxation) and health status (pain, fatigue, anxiety, depression and positive affect). At 4 months follow-up, the ASMP had a significant effect on arthritis self-efficacy for other symptoms and pain subscales. Performance of a range of health behaviours (cognitive symptom management, communication with physicians, dietary habit, exercise and relaxation) was significantly greater among the Intervention Group. The Intervention Group were significantly less depressed and had greater positive mood. In addition, trends towards decreases on fatigue and anxiety were noted. Physical functioning, pain and GP visits remained stable at 4 months. A similar pattern of findings was found at 12 months follow-up for the Intervention Group. Furthermore, a significant improvement was found on pain and visits to GPs had decreased. Apart from a small improvement on physical functioning among the Intervention Group participants with osteoarthritis 12 months, all effects were independent of the type of arthritis. The findings suggest that the ASMP is effective in promoting improvements in perception of control, health behaviours and health status, when delivered in UK settings.", "A computer based education (CBE) lesson was developed for patients with rheumatoid arthritis (RA) and evaluated using a controlled experiment. There were statistically significant differences in the CBE group compared with controls in knowledge gained (p less than 0.01), improved outlook on life (p less than 0.01), hopefulness of a good prognosis (p less than 0.01), decreased belief in the role of luck or fate in determining their health (p less than 0.05) and reported increase in use of behaviors such as joint protection (p less than 0.02) and rest (p less than 0.05). The lesson was accepted and enjoyed by the patients.", "Psychoeducational preparation is known to improve postoperative outcome. We tested two common psychoeducational procedures in elderly orthopedic patients, examining how best to match interventions to patients by psychological type.\n Two hundred twenty-two elderly patients undergoing total hip or knee replacement were randomly assigned to 1) a slide-tape with information on the postoperative, in-hospital rehabilitation experience, or 2) training in Benson's Relaxation Response with a bedside audiotape, in a 2 x 2 factorial design.\n The relaxation response did not influence postoperative outcomes. The educational intervention reduced length of stay and pain medication use for patients who exhibited most denial (tendency to avoid thinking about unpleasant events), and reduced postoperative anxiety and cognitive errors on the Mini-Mental State Exam for patients with most baseline anxiety. There was no effect on postoperative pain.\n The importance of attending to the patient's psychological state and level of preparation before orthopedic surgery is reinforced. Patients who exhibit most denial and highest anxiety may benefit from educational interventions, but patients' directly expressing desire for information may be a poor guide in deciding which patients would benefit, compared with more formal psychological testing for denial and anxiety.", "A randomized clinical trial was performed to evaluate a psychological treatment intervention and a social support program, compared with a control program in which no adjunct treatment was rendered, and their effects upon pain behavior, affect, and disease activity of 53 patients with rheumatoid arthritis. The psychological intervention produced significant reductions in patients' pain behavior and disease activity at posttreatment. Significant reductions were also observed in trait anxiety at posttreatment and 6-month followup. Relaxation training may have been the most important component of the psychological intervention. The social support program produced a significant reduction in trait anxiety only at posttreatment. This is the first well-controlled study to demonstrate reduced pain behavior, disease activity, and trait anxiety following psychological treatment.", "This study examined the efficacy of a cognitive and behavioural intervention (CBT) for patients with recent onset, seropositive rheumatoid arthritis. Fifty-three participants with a diagnosis of classical or definite rheumatoid arthritis, who were seropositive and had less than 2 years of disease history were recruited into the trial. All participants received routine medical management during the study, although half were randomly allocated to receive an adjunctive psychological intervention. All pre- and post-treatment assessments were conducted blind to the allocation. Analyses were conducted of treatment completers and also by intention-to-treat. Significant differences were found between the groups at both post-treatment and 6-month follow-up in depressive symptoms. While the CBT group showed a reduction in depressive symptoms, the same symptoms increased in the Standard group. At outcome but not follow-up, the CBT group also showed reduction in C-reactive protein levels. However, the CBT group did show significant improvement in joint involvement at 6-month follow-up compared with the Standard group, indicating physical improvements above those achieved with standard care. These results indicate that cognitive-behavioural intervention offered as an adjunct to standard clinical management early in the course of RA is efficacious in producing reductions in both psychological and physical morbidity", "Preliminary work regarding the development and pilot study of an individualized instructional program for rheumatoid arthritis clients is presented. The effect of the individualized instructional program was tested with 31 outpatients. Using analysis of covariance, the experimental group subjects scored significantly higher on the knowledge post-test when compared to scores of control group subjects (P = 0.0045). Analysis of variance for repeated measures revealed no significant difference in performance of tasks for the control group and experimental group (P = 0.08). In a follow-up study, the effect of the self-instructional program, practice time, and contracting were explored for their effect on adherence to self-care activities. Experimental groups (n = 42) scored significantly better than the control group (n = 11) on the knowledge post-test (P < 0.01), performance of joint protection practices (P = 0.01), range of motion exercises (P = 0.01), and adherence to joint protection practices at home (P < 0.01). Groups did not differ on adherence to range of motion exercises at home (P = 0.83).", "Behavioral and health status outcomes of an unreinforced, self-help education program for arthritis patients taught by lay persons were examined in 2 ways: a 4-month randomized experiment and a 20-month longitudinal study. At 4 months, experimental subjects significantly exceeded control subjects in knowledge, recommended behaviors, and in lessened pain. These changes remained significant at 20 months. The course was inexpensive and well-accepted by patients, physicians, and other health professionals.", "One hundred subjects with arthritis were randomized into lay-taught, or professional-taught 12-h arthritis self-management courses, or a control group. Outcomes, knowledge, exercise, relaxation, disability, pain, and number of physician visits were measured aat baseline and 4 months. Professional-taught groups demonstrated greater knowledge gain while lay-taught groups had greater changes in relaxation (p less than .01) and a tendency toward less disability. Although it is impossible to draw definitive conclusions, this study suggests that lay leaders can teach arthritis self-management courses with results similar to those achieved by professionals.", "To assess the sustainable benefits of a professional, multidisciplinary training program for patients with rheumatoid arthritis.\n Two studies with different observation periods. Study I was a prospective, randomized trial for 1 year. Study II was a noncontrolled observation over 5 years.\n The 9-day program for eight patient groups encompassed a multidisciplinary cooperation between rheumatologists, orthopedists, physicotherapists, psychologists and social workers.\n Sixty-eight consecutive patients with rheumatoid arthritis participated in an arthritis training program either immediately after enrollment in the program or after 1 year.\n The program covered the following fields: pathogenesis of rheumatoid arthritis, drug therapy, physicotherapy, practical exercise in remedial gymnastics, use of joint protection devices, orthopedic perspectives, psychological counseling, dietetics, information about unproven cures and social assistance.\n Clinical outcome was assessed by self-report questionnaires: (1) Stanford Health Assessment Questionnaire, (2) Freiburg Questionnaire of Coping with Illness, (3) Beck Depression Inventory, and (4) a 21-point scale to evaluate cognitive-behavioral and environmental impact.\n A significant and persistent improvement of all investigated parameters was demonstrated in the 1-year controlled trial. Between the end-point of the 1-year study and the 5-year evaluation, this improvement increased even more for functional status and coping with illness, whereas depression returned to baseline values. These effects were seen even without reinforcement of the training.\n A professional, multidisciplinary approach to educate patients with rheumatoid arthritis leads to a significant and sustained improvement of the clinical outcome and is an approach that should be established as a part of conventional therapy.", "We tested the effectiveness of a 6-month person-centered (PC), nondirective, telephone-based counseling intervention for improving the psychological status of persons with systemic lupus erythematosus (SLE) or rheumatoid arthritis (RA).\n The design was a parallel-group, randomized, controlled study comparing a PC counseling intervention (8 SLE, 28 RA patients) with usual care (7 SLE, 30 RA patients). The Arthritis Impact Measurement Scales was used to measure psychological dysfunction, physical dysfunction, and pain at baseline and at followup.\n The main finding was that the PC counseling intervention significantly improved the psychological status of the SLE patients (P < 0.05, effect size = 1.13, responsiveness = 0.77) in comparison to usual care. There was no evidence of a benefit for persons with RA or of improvements in physical function or pain for persons with either disease.\n PC counseling may be an effective intervention for improving the psychological status of persons with SLE, but may not be for those with RA.", "The effects of treatment counseling or symptom monitoring telephone intervention strategies on the health outcomes of patients with rheumatoid arthritis (RA) or osteoarthritis (OA), compared with usual care, were assessed.\n A 3-group, randomized, controlled 9-month trial was conducted incorporating 405 patients with RA or OA and using the Arthritis Impact Measurement Scales (AIMS2) as the outcome measure.\n Analyses of covariance showed that the AIMS2 total health status of the treatment counseling group (effect size = 33, P < 0.01), but not the symptom monitoring group (effect size = 0.21, P = 0.10), was significantly improved, compared with usual care, for both RA and OA patients. The specific types of benefits differed significantly between RA and OA patients. The mean number of medical visits by OA patients in the treatment counseling group was also significantly reduced (P < 0.01).\n Telephone contact using the treatment counseling strategy produced significant, but different, health status benefits for RA and OA patients. The symptom monitoring strategy produced modest benefits.", "The efficacy of psychological treatment to reduce pain has recently been shown in a number of studies. They are considered to enhance or even replace medical approaches in pain management, especially in chronic pain-states. The study reported here aimed to test two established (multimodal pain management, relaxation training) and one newly designed approach (visualization techniques) in comparison with a control group (medical treatment alone). The study was conducted with in-patients (N = 46; rheumatoid arthritis). Medical and pain data were gathered before and after treatment. Patients also filled out questionnaires in the beginning and at the end of the study assessing pain-experience, emotional states and capability to cope with pain. Patients participating in the multimodal pain management group and the visualization group profited from participation (especially in pain reduction) only if they gained substantially extents in the capability to cope with pain. Simply taking part in the groups and not reaching acceptable measures to cope with pain had no or negative effects. Both approaches were clearly above the control- and the relaxation-condition (relaxation participants were hardly better than the controls). The range of efficacy was broadest in the multimodal group (in addition to pain-reduction, substantial improvements in emotional states were obtained). However, visualization techniques, which were tested empirically for the first time here, can also be recommended as pain management therapy.", "This experiment tested a cognitive-behavioral rheumatoid arthritis treatment designed to confer skills in managing stress, pain, and other symptoms of the disease. We hypothesized that a mediator of the magnitude of treatment effects might be enhancement of perceived self-efficacy to manage the disease. It was predicted that the treatment would reduce arthritis symptoms and possibly would improve both immunologic competence and psychological functioning. The treatment provided instruction in self-relaxation, cognitive pain management, and goal setting. A control group received a widely available arthritis helpbook containing useful information about arthritis self-management. We obtained suggestive evidence of an enhancement of perceived self-efficacy, reduced pain and joint inflammation, and improved psychosocial functioning in the treated group. No change was demonstrated in numbers or function of T-cell subsets. The magnitude of the improvements was correlated with degree of self-efficacy enhancement.", "Joint protection (JP) is a self-management technique widely taught to people with rheumatoid arthritis (RA). JP education aims to enable people with RA to reduce pain, inflammation, joint stress and reduce risks of deformity through using assistive devices and alternative movement patterns of affected joints to perform everyday activities. Previous studies evaluating JP education methods common in the UK have identified JP adherence is poor. A group education programme was developed using the Health Belief Model and Self-efficacy Theory. Strategies used to maximise JP adherence included goal-setting, contracting, modelling, homework programmes, motor learning theory, recall enhancing methods and mental practice. A crossover trial (n = 35) was conducted. Adherence with JP was measured using an objective observational test (the Joint Protection Behaviour Assessment). Significant improvements in use of JP were recorded at 12 and 24 weeks post-education (P < 0.01). No significant changes in measures of pain, functional disability, grip strength, self-efficacy or helplessness occurred post-education, although this may have been due to the small sample size recruited. In conclusion, JP adherence can be facilitated through the use of educational-behavioural strategies, suggesting this approach should be more widely adopted in clinical practice.", "We examined the effectiveness of 2 models of arthritis self-care intervention, the home study model and the small group model. The effects of disease diagnosis and duration, self-care behavior, perceived helplessness, social support, treatment choice, and formal education level on outcomes among persons with arthritis who participated in these programs were evaluated. A pretest-posttest control group design was utilized in the initial experimental study; comparison group designs were used in the longitudinal studies. Three hundred seventy-four subjects completed the interventions and 12 months of research followup. We found that the intervention models had a statistically significant positive impact on arthritis knowledge, self-care behavior, perceived helplessness, and pain. These findings did not vary when the effects of education level, disease diagnosis and duration, informal social support, and treatment choice were controlled. The small group intervention was more effective in bringing about initial improvements in pain and depression, whereas the home study intervention was more effective in maintaining improvements in perceived helplessness. Changes in perceived helplessness and self-care behavior appear to explain in part the observed improvement in pain.", "To examine the effectiveness of a cognitive-behavioral pain management program for patients with rheumatoid arthritis, three patient groups were studied: a cognitive-behavioral group (CB), an attention-placebo group, and a control group. The CB group received a comprehensive, 12-month pain management program that taught coping strategies such as problem-solving techniques, relaxation training, strategies for attention diversion, and training in family dynamics and communication. Dependent measures included pain, coping strategies, psychological status, functional status, and disease status. Data analysis at 12 months revealed benefits for the CB group in the area of enhanced coping strategies. Specifically, the CB subjects showed significantly greater use of coping strategies and significantly more confidence in their ability to manage pain. The findings are discussed in terms of the importance of enhanced self-efficacy and personal control for patients with rheumatoid arthritis.", "Self-instruction is one means of providing patient education, allowing the health professional to teach a larger number of persons than with one-to-one or group instruction and at a lower cost. The purpose of this study was to examine the effects of self-instruction on learning, satisfaction with the teaching approach, and health status of persons with rheumatoid arthritis (RA). A control-group pretest-posttest design was used. Thirty subjects receiving care at a rheumatology clinic who met study criteria were randomly assigned to two groups: self-instruction and control. One-way analysis of covariance on posttest Rheumatoid Arthritis Knowledge Inventory (RAKI) scores, with the pretest as covariate, was used to examine the difference in learning between the self-instruction and control groups. There was a significant difference between the groups (P = 0.01). Participants who completed the self-instructional program had improved scores on the posttest as compared to the control. Subjects rated self-instruction as an effective teaching strategy in terms of promoting learning about RA and patient acceptability. t-Test demonstrated no significant difference between the groups in health status. Significant correlations were found between subjects' test scores and selected variables.", "Self-management courses in arthritis have been shown to improve outcomes and to decrease medical resource utilization. We studied the effectiveness of a mail-delivered arthritis self-management program with the potential for extending these effects more broadly.\n Randomized controlled trial of 375 program participants and 434 controls over a 6 month period. Baseline and 6 month data were analyzed for each group and between groups by paired 2 sample t test. The intervention consists of health assessment questionnaires at 3 month intervals, with computer processed recommendation letters and reports individualized to age, diagnosis, education level, disability, pain, medication, and other patient-specific variables.\n At 6 months, outcomes of function (4.7%; 95% confidence limits 2.7, 6.7), decreased pain (9%; 2.8, 15.2), global vitality (7%; 2.8, 11.2), and joint count (28%; 20, 36) were improved in the program group compared with controls (p < 0.01). Exercise (35%; 26, 44) and self-efficacy (14.7%; 9, 20) were increased in the program group but not controls (p < 0.001). Doctor visits/year were decreased by 16% (3, 29) in the program group compared with controls (p < 0.05) and days missed work or confined to home decreased by 52% (-3, 107) in the program group compared with controls (p = 0.06). At one year, patients in the original program group continued to improve, and the control group, provided with the program in the second 6 months, showed improvement similar to the first 6 months of the original program group.\n A mail-delivered arthritis self-management program can positively affect patient outcomes and can decrease medical resource utilization.", "To develop and evaluate the effect of a new arthritis education program based on a previous study.\n One hundred individuals with established rheumatoid arthritis randomized to an intervention group or a control group completed self-report questionnaires.\n Three months after the education program the patients in the intervention group had increased their knowledge about their disease. They reported increased practice of exercise and joint protection and reduction of disability and pain. After 12 months, increased knowledge and practice of joint protection was maintained. However, there was no longer any difference between the intervention group and the control group regarding reported pain, disability, and practice of exercise. At both intervals the individuals in the intervention group reported an increased ability to handle their pain and a reduction of problems with their disease. The control group remained stable except for a slight increase in pain.\n A structured patient education program had positive impact for 3 months, and some improvements were maintained for 12 months. We suggest that patient education should become an integrated part of the total management of rheumatoid arthritis.", "To determine 4-month and 1-year health-related outcomes of a 6-week, lay-led, and community-based arthritis self-management program for Spanish-speaking participants and to determine the role of self-efficacy in predicting health status for this population.\n Three hundred and thirty one subjects were randomized to the program or to a 4-month wait list control group. One hundred ninety eight subjects continued in a 1-year longitudinal study. Data were collected via mailed questionnaires with telephone follow up.\n At 4 months, treatment subjects, compared with controls, demonstrated positive changes in exercise, disability, pain, and self-efficacy (P < 0.05). At 1 year, compared with baseline, treatment subjects demonstrated improvements in exercise, general health, disability, pain, self-efficacy, and depression (P < 0.05). Baseline and 4-month changes in self-efficacy predicted health status at 1 year.\n Spanish-speaking participants of an arthritis self-management program demonstrate short- and long-term benefits (improved health behaviors, health status, and self-efficacy).", "This study evaluated the effectiveness (changes in health behaviors, health status, and health service utilization) of a self-management program for chronic disease designed for use with a heterogeneous group of chronic disease patients. It also explored the differential effectiveness of the intervention for subjects with specific diseases and comorbidities.\n The study was a six-month randomized, controlled trial at community-based sites comparing treatment subjects with wait-list control subjects. Participants were 952 patients 40 years of age or older with a physician-confirmed diagnosis of heart disease, lung disease, stroke, or arthritis. Health behaviors, health status, and health service utilization, as determined by mailed, self-administered questionnaires, were measured.\n Treatment subjects, when compared with control subjects, demonstrated improvements at 6 months in weekly minutes of exercise, frequency of cognitive symptom management, communication with physicians, self-reported health, health distress, fatigue, disability, and social/role activities limitations. They also had fewer hospitalizations and days in the hospital. No differences were found in pain/physical discomfort, shortness of breath, or psychological well-being.\n An intervention designed specifically to meet the needs of a heterogeneous group of chronic disease patients, including those with comorbid conditions, was feasible and beneficial beyond usual care in terms of improved health behaviors and health status. It also resulted in fewer hospitalizations and days of hospitalization.", "To examine the effects of stress-management training on clinical outcomes in persons with rheumatoid arthritis (RA).\n Patients with RA (n = 141) were randomly assigned to 1 of 3 groups: a stress management group, an attention control group, or a standard care control group. The stress management and the attention control groups received a 10-week intervention followed by an additional 15-month maintenance phase.\n The stress management group showed statistically significant improvements on measures of helplessness, self-efficacy, coping, pain, and health status. Selected beneficial effects were still detectable at the 15-month followup evaluation.\n The data indicated that stress management interventions are capable of producing important clinical benefits for persons with RA." ]

[ "8018617", "12738519", "15653210", "17368254", "15713151", "15291994", "10898185", "17499419", "15922988", "20499747", "19423098" ]

[ "Intramyometrial vasopressin as a haemostatic agent during myomectomy.", "Use of a single preoperative dose of misoprostol is efficacious for patients who undergo abdominal myomectomy.", "Oxytocin during myomectomy: a randomized study.", "Oxytocin infusion in laparoscopic myomectomy may decrease operative blood loss.", "Reducing blood loss at open myomectomy using triple tourniquets: a randomised controlled trial.", "Bupivacaine plus epinephrine for laparoscopic myomectomy: a randomized placebo-controlled trial.", "Chemically assisted dissection of tissues: an interesting support in abdominal myomectomy.", "Intravenous tranexamic acid use in myomectomy: a prospective randomized double-blind placebo controlled study.", "Laparoscopic myomectomy: enucleation of the myoma by morcellation while it is attached to the uterus.", "The use of torniquet to reduce blood loss at myomectomy.", "Reducing blood loss at myomectomy with use of a gelatin-thrombin matrix hemostatic sealant." ]

[ "To assess the efficacy of intramyometrial vasopressin for minimising bleeding and its sequelae at myomectomy.\n A randomised placebo controlled trial.\n University Hospital of the West Indies, Kingston, Jamaica.\n Twenty women with symptomatic uterine fibroids scheduled for myomectomy who satisfied entry criteria: 10 randomised to the vasopressin group and 10 to the control group.\n Myomectomy was performed after the intramyometrial injection of either 20 units vasopressin diluted to 20 ml in normal saline or placebo (20 ml normal saline).\n The efficacy of vasopressin was measured by comparing pre- and post-operative haemoglobin levels and haematocrit, changes in intra-operative pulse and blood pressure, measured blood loss, need for blood transfusion and post-operative febrile morbidity in the treatment and control groups.\n The use of vasopressin resulted in median blood loss of 225 ml (range 150-400 ml) compared with 675 ml (range 500-800 ml) in the placebo group (P < 0.001). The vasopressin group had a correspondingly lower fall in haemoglobin level (median 1.7 g/dl vs 5.3 g/dl, P < 0.001) and haematocrit (median 5% vs 13%, P < 0.001) compared with the controls. Fifty percent of the placebo group had blood transfusions compared with none in the vasopressin group (P = 0.03). There were no significant differences between the groups in intra-operative pulse and blood pressure or post-operative white blood cell counts or temperature.\n The results indicate that vasopressin is effective in preventing blood loss and reducing the need for blood transfusion during myomectomy.", "To investigate the effectiveness of a single preoperative dose of misoprostol in abdominal myomectomies.\n Placebo-controlled randomized prospective study.\n Department of obstetrics and gynecology in a university hospital.\n Twenty-five women with symptomatic uterine leiomyomas.\n Among patients undergoing abdominal myomectomies, an hour before the operation women in the study group (n = 13) were given a single dose of vaginal misoprostol (400 microg); those in the control group (n = 12) were given placebo.\n Intraoperative blood loss, duration of operation, duration of postoperative hospitalization, and the need for blood transfusion were compared between the control and study groups.\n Blood loss, operation time, and need for postoperative blood transfusion were significantly reduced in the group given vaginal misoprostol. No difference was observed among patients in terms of the time of hospitalization.\n A single preoperative dose of vaginal misoprostol is a simple, reliable method for reducing intraoperative blood loss and need for postoperative blood transfusion after abdominal myomectomies.", "To evaluate the influence of oxytocin on peroperative blood loss during myomectomy.\n From October 1998 to May 2002, 94 patients requiring surgical myomectomy by laparotomy or by the vaginal approach were enrolled in a randomized double blind study. Patients were randomized to two groups. In the first group (47 patients) oxytocin was administered during myomectomy and in the second group (47 patients) a placebo was used. The main outcome measures were peroperative blood loss and rates of blood transfusion and autotransfusion.\n Peroperative blood loss was no different between the oxytocin group and the placebo group (508 +/- 558 ml versus 451 +/- 336 ml; P=0.55). Rates of autotransfusion and blood transfusion were also similar in both groups.\n Administration of oxytocin during myomectomy did not reduce peroperative blood loss in our study. The benefits of using oxytocin to prevent hemorrhage during myomectomy seem to be limited.", "To evaluate the influence of oxytocin on operative blood loss during laparoscopic myomectomy (LM).\n Prospective clinical study (Canadian Task Force classification I).\n Tertiary care university hospital.\n Sixty women scheduled for myomectomy because of symptomatic uterine myomas.\n Two ampules of oxytocin (10 u/mL/amp) were added to 1000 mL of saline solution running at the rate of 40 mU/min during the course of LM.\n Blood loss and blood transfusion rate were significantly greater in the group without oxytocin infusion (group B) than in the group with oxytocin infusion (group A), with 445.0 +/- 268.6 mL (95% CI 344.7-545.3) versus 269.5 +/- 225.8 mL (95% CI 185.2-353.8)/(p <.05), and 36.7% versus 6.7% (p <.05), respectively. There was no significant difference in average age, body weight, or numbers of vaginal delivery and cesarean sections between the 2 groups. There was no significant difference in mean total myoma weight, main myoma size, postoperative stay, and complications between the 2 groups.\n Oxytocin infusion combined with skillful surgical techniques may decrease operative blood loss and blood transfusion during LM.", "To evaluate triple tourniquets in controlled conditions and for the first time to investigate the hypothesis that leaving a semi-permanent tourniquet around the uterine artery reduces post-operative bleeding from the uterine incisions.\n A randomised controlled trial.\n Two University teaching hospitals.\n Twenty-eight patients with symptomatic fibroids and uterine sizes ranging from 14 to 24 weeks of gestation undergoing open myomectomy.\n A number 1 polyglactin suture was tied around the cervix to occlude the uterine arteries, and polythene tourniquets were tied around the infundibulopelvic ligament to obstruct the ovarian vessels. At the end of the procedure, the ovarian ties were released but the uterine artery suture remained in situ.\n Intra-operative blood loss, post-operative blood loss, blood transfusion rates, operative morbidity, uterine blood flow and ovarian function.\n There was significantly less blood lost in the tourniquet group than in the control group (difference between means 1870 mL, 95% CI 1159-2580 mL, P < 0.0001; transfusion rates of 7% and 79%, P= 0.0003). The volume in the pelvic drain 20 min post-operatively and after 48 hours failed to reach statistical significance between the two groups (P= 0.10 and P= 0.165). There were no differences in uterine artery Doppler resistance indices at five days (P= 0.54), six weeks (P= 0.47), three months (P= 0.49) and at six months (P= 0.18). Day two serum FSH concentrations after surgery were unchanged (P= 0.45), compared with baseline values.\n Triple tourniquets are effective in reducing bleeding and transfusion rates. There appears no obvious adverse effect on uterine perfusion or ovarian function.", "To evaluate the effectiveness of the injection of bupivacaine plus epinephrine before laparoscopic myomectomy.\n Sixty premenopausal women with uterine leiomyomata were enrolled in a randomized controlled design and intraoperatively treated with injection of bupivacaine plus epinephrine (group A) or saline solution (group B) during laparoscopic myomectomy. Uterine size and volume, number of leiomyomata, hematological parameters, total operative time, enucleation time of each myoma, suturing time of the myomectomy, blood loss, degree of surgical difficulty, and postoperative pain were evaluated. Just before and after the injection of vasoconstrictive or saline solution, systolic and diastolic blood pressure and heart rate were recorded in each subject.\n Blood loss, total operative and enucleation time, and degree of surgical difficulty was significantly (P <.05) lower in group A than in group B. No difference was observed between groups in suturing time of the myomectomy. The number of vials of pain medication used postoperatively was significantly (P <.05) lower in group A than in group B. No differences in systolic and diastolic blood pressure or heart rate was recorded between the 2 groups.\n The injection of bupivacaine plus epinephrine during laparoscopic myomectomy is effective in reducing blood loss, total operative and enucleation time, degree of surgical difficulty, and postoperative pain.", "The aim of this study was to verify the efficacy of sodium-2-mercaptoethanesulfonate (mesna) in the chemical separation of tissues in abdominal myomectomies when used with the traditional mechanical separation techniques.\n In a prospective, randomized study, 58 women underwent abdominal myomectomy. In 29 of these, we used mesna for highlighting and separating tissues, and in the other 29 we used saline solution for the same purposes. The variables evaluated included the number of myomas removed, the volume of the biggest myoma, and the total volume of the myomas removed in every intervention. We also recorded operating time, the length of hospital stay, the degree of procedure difficulty, perioperative blood loss, operative complications, and cost.\n The operation was significantly shorter in the mesna group (p < 0.05) even though the volume and the number of myomas were larger. The degree of difficulty evaluated by the surgeon at the end of every operation was not significantly different in the two groups. The reduction in hemoglobin 24 hours after operation was significantly less in the patients treated with mesna (p = 0.006), but this difference was probably altered by the increase in hematocrit levels.\n Because of its ability as a chemical dissector, mesna may be a useful aid in this type of benign gynecologic operation. Larger studies to confirm this are needed.", "To define the effect of tranexamic acid use on perioperative and postoperative bleeding and blood transfusion requirements in women undergoing myomectomy.\n Among the patients that underwent myomectomy a total of 100 cases were included in the study. The patients (n=50) randomized to receive tranexamic acid were defined as Group I and those receiving saline were defined as Group II. Perioperative blood loss was calculated by measuring the volume in the suction apparatus and weighing the swabs. Postoperative blood loss was defined as the blood volume found in the subfascial suction drain. The two groups were compared for age, body mass index, basal hemoglobin and hematocrit, basal parameters of coagulation, the number and the volume of myomas removed, peri- and postoperative and total blood loss, duration of surgery and blood transfusion requirements.\n No significant difference was found between the two groups when compared age, body mass index, preoperative blood analysis, the number and volume of myomas removed. Statistically significant differences were found between the two groups when compared for postoperative and total blood loss and duration of surgery (p<0.01, p=0.03 and p=0.03, respectively). Perioperative blood loss and blood transfusion requirements were similar between the two groups (p=0.12 and p=0.25, respectively). There were no complications in either group.\n Our study is the first in the literature evaluating the effectiveness of tranexamic acid use on peri- and postoperative bleeding in gynecological surgery. No additional benefit of intravenous infusion of tranexamic acid was found. Tranexamic acid does not seem to be a useful adjunct in myomectomy if given according to the described protocol in this study.", "To evaluate the feasibility, blood loss, length of surgery, mean hospital stay, and complications of enucleation of a myoma by morcellation while it is still attached to the uterus and to compare the technique with the standard technique of laparoscopic myomectomy.\n Randomized study (Canadian Task Force classification II-2).\n Private endoscopy center.\n Forty-four patients with symptomatic myomas confirmed by ultrasound examination were included in the study from January 2000 through December 2001 and were randomized into two groups-A and B. The inclusion criteria were the presence of a uterus larger than 12 weeks (on bimanual examination), ultrasound confirmation of the presence of at least one myoma 7 cm or greater in size, and/or presence of three or more myomas greater than 5 cm in size.\n The technique of laparoscopic myomectomy by enucleation of a myoma by morcellation while it is still attached to the uterus was performed in all patients in Group A. The patients in Group B underwent laparoscopic myomectomy by the conventional technique of complete enucleation of the myoma followed by morcellation.\n Forty-nine myomas were removed in group A and 35 in group B. The mean weight of the myomas removed in each patient was 600.5 +/- 369.1 g in group A (95% CI 452.83-748.17 g) and 584.2 +/- 411.1 g in group B (95% CI 404.05-764.45 g) (p = .706). The mean blood loss was 283.9 +/- 229.3 mL in group A (95% CI 192.20-375.72 mL) and 218.5 +/- 110.7 mL in group B (95% CI 169.96-267.04 mL) (p = .739), the mean hospital stay was 37.91 +/- 5.44 hours in group A (95% CI 35.74-40.10 hours) and 39.5 +/- 3.634 hours in group B (95% CI 37.91-41.09 hours) (p = .236). The mean length of surgery was significantly shorter in group A (97.7 +/- 27.06 min, 95% CI 86.88-108.54 minutes) as compared with that in group B (123 +/- 38.8 min 95% CI 106.93-140.57 minutes), (p = .013).\n Preliminary results suggest that laparoscopic myomectomy employing the technique of enucleation of a myoma by morcellation while it is still attached to the uterus is safe and efficient. It helps to overcome certain technical difficulties inherent in the standard technique of laparoscopic myomectomy. It may help to relax the inclusion criteria of patients with myoma for laparoscopic myomectomy based on the size of the myoma.", "Fibroids remain the commonest pelvic tumour seen in women with myomectomy being the major form of treatment in our environment. Techniques to minimize blood loss will reduce patient morbidity and the need for blood transfusions. One such technique is the use of a tourniquet during myomectomy operation. This study examines the effectiveness and safety this tourniquet technique.\n A comparative analysis of the blood loss, transfusion rate and the morbidities associated with the use and non-use of a tourniquet during myomectomy operation at Nnamdi Azikiwe University Teaching Hospital, Nnewi Nigeria was undertaken. The Foley's urethral catheter was adapted as a uterine tourniquet and applied as low as possible at the base of the uterus before enucleating the fibroid masses.\n The patients who had their myomectomy performed with application of a tourniquet [tourniquet group] and those without [no-tourniquet group] were evenly matched for age, parity and presenting symptoms. The overall mean age of patients was 35.7 +/- 6.1 years and parity was 0.40 +/- 1.25. The main presenting symptoms of the patients were lower abdominal mass 65.6%, menorrhagia 38.7%, infertility 33.3%, abdominal pain 19.4% and dysmenorrhoea 14.0%. There was a statistically significant difference [P < 0.001] in mean blood loss for the no-tourniquet group [756.4 +/- 285.7] and the tourniquet group [515.7 +/- 292.8] as well as the mean blood transfusion rate in no-tourniquet group [1.0 units +/- 1.14] and the tourniquet group [0.24 units +/- 0.51]. However there was no significant difference between the two groups with respect to complication profile.\n The Foley's catheter form of tourniquet is cheap, safe, effectively reduces blood loss during myomectomy and significantly reduces transfusion rate while not adding to the complications due to the operation.", "To evaluate the hemostatic efficacy and handling of gelatin-thrombin matrix in abdominal myomectomy.\n Prospective and randomized trial.\n University teaching hospital.\n Women (n = 50) with uterine fibroids with a uterine size equivalent to > or =16 weeks gestation.\n Gelatin-thrombin matrix (FloSeal Matrix; Baxter Healthcare Corp., Fremont, CA) was delivered to the site of the uterine bleeding during myomectomy.\n Patient age, parity, number of myomas, operative time, blood loss, transfusion, intraoperative and postoperative complications, and length of hospitalization were evaluated.\n The average blood loss during surgery was 80 +/- 25.5 mL for the FloSeal group and 625 +/- 120.5 mL for the control group. Intraoperative blood transfusion was necessary in five patients from the control group. Postoperative blood loss was 25 +/- 5 mL for the FloSeal group and 250 +/- 75 mL for the control group. Length of the postoperative hospital stay was 2.5 +/- 1.2 days for FloSeal group and 4.5 +/- 1.3 for the control group. No major immediate or delayed complications were observed in either group.\n Reductions in hemorrhage in FloSeal-treated women undergoing a myomectomy are encouraging, and provide evidence for the ability of gelatin-thrombin matrix to reduce blood loss when applied immediately and directly to bleeding uterine tissue." ]

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[ "Hyperfractionated photon radiation therapy in the treatment of advanced squamous cell carcinoma of the oral cavity, pharynx, larynx, and sinuses, using radiation therapy as the only planned modality: (preliminary report) by the Radiation Therapy Oncology Group (RTOG).", "A Radiation Therapy Oncology Group (RTOG) phase III randomized study to compare hyperfractionation and two variants of accelerated fractionation to standard fractionation radiotherapy for head and neck squamous cell carcinomas: first report of RTOG 9003.", "Phase III randomized trial of very accelerated radiation therapy compared with conventional radiation therapy in squamous cell head and neck cancer: a GORTEC trial.", "Comparison of toxicity associated with early morning versus late afternoon radiotherapy in patients with head-and-neck cancer: a prospective randomized trial of the National Cancer Institute of Canada Clinical Trials Group (HN3).", "Fast-neutron therapy in advanced head and neck cancer: a collaborative international randomized trial.", "A randomised trial of accelerated and conventional radiotherapy for stage III and IV squamous carcinoma of the head and neck: a Trans-Tasman Radiation Oncology Group Study.", "Accelerated versus conventional fractionated postoperative radiotherapy for advanced head and neck cancer: results of a multicenter Phase III study.", "Concomitant cisplatin and radiotherapy in a conventional and modified fractionation schedule in locally advanced head and neck cancer: a randomised phase II EORTC trial.", "[Preoperative short-term preliminary irradiation with 3 x 6 Gy, immediate radical tumor resection and postoperative booster irradiation to 60 Gy as an effective therapy concept for the treatment of T2 squamous cell carcinomas of the mouth. Results of a prospective randomized bi-center study].", "Hyperfractionation versus conventional fractionation in oropharyngeal carcinoma: final analysis of a randomized trial of the EORTC cooperative group of radiotherapy.", "Irradiation twenty-four hours preoperatively.", "Proceedings: Preoperative irradiation for head and neck cancer: a prospective study.", "Fast neutron radiation therapy for unresectable squamous cell carcinomas of the head and neck: the results of a randomized RTOG study.", "Continuous hyperfractionated accelerated radiotherapy with/without mitomycin C in head and neck cancers.", "Mixed neutron/photon irradiation of unresectable squamous cell carcinomas of the head and neck: the final report of a randomized cooperative trial.", "\"Compensated\" split-course versus continuous radiation therapy of carcinoma of the tonsillar fossa. Final results of a prospective randomized clinical trial of the Radiation Therapy Oncology Group.", "Evaluation of a neutron boost in head and neck cancer. Results of the randomized RTOG trial 78-08.", "Continuous accelerated 7-days-a-week radiotherapy for head-and-neck cancer: long-term results of phase III clinical trial.", "Preoperative irradiation for head and neck cancer: results of a prospective study.", "Phase III trial of high- vs. low-dose-rate interstitial radiotherapy for early mobile tongue cancer.", "Accelerated fractionation (AF) compared to conventional fractionation (CF) improves loco-regional control in the radiotherapy of advanced head and neck cancers: results of the EORTC 22851 randomized trial.", "Dose-response for local control with hyperfractionated radiation therapy in advanced carcinomas of the upper aerodigestive tracts: preliminary report of radiation therapy oncology group protocol 83-13.", "High fractional dose irradiation of advanced head and neck cancer. Implications for combined radiotherapy and surgery.", "Prospective randomized trial comparing hyperfractionated versus conventional radiotherapy in stages III and IV oropharyngeal carcinoma.", "Fast neutron treatment for squamous cell carcinoma of the head and neck: final report of Edinburgh randomised trial.", "Locoregionally advanced carcinoma of the oropharynx: conventional radiotherapy vs. accelerated hyperfractionated radiotherapy vs. concomitant radiotherapy and chemotherapy--a multicenter randomized trial.", "Concomitant boost radiotherapy compared with conventional radiotherapy in squamous cell carcinoma of the head and neck--a phase III trial from a single institution in India.", "Randomized trial addressing risk features and time factors of surgery plus radiotherapy in advanced head-and-neck cancer.", "Randomized phase I/II trial of two variants of accelerated fractionated radiotherapy regimens for advanced head and neck cancer: results of RTOG 88-09." ]

[ "From August 1979 to June 1983, the RTOG conducted a prospective Phase III study that compared a standard schedule with five fractions per week of 180 to 200 cGy per day to a total dose of 6600-7380 cGy, with a hyperfractionation regimen consisting of two fractions of 120 cGy per day, separated by a rest period of 3 to 6 hours for a total of 6000 cGy. A total of 210 patients were entered, of which 187 are analyzed. Complete initial tumor clearance in the head and neck was achieved by radiotherapy in 61% of the patients assigned to the standard schedules and in 59% of those assigned to the continuous hyperfractionation schedule; surgical salvage contributed towards achieving complete response in 5% and 7% of patients, respectively. The Kaplan-Meier estimates for loco-regional control of tumor at 1 and 2 years was 39% and 29% for the standard schedules, and 43% and 30% for the hyperfractionation schedule. The endpoints examined to evaluate therapeutic effects do not indicate that the stated hyperfractionation schedule is different than the standard RTOG treatment schedule for head and neck cancer. Acute normal tissue reactions appear to be more severe with the hyperfractionation schedule but the incidence of late reactions is similar in both groups. There is a tendency toward more severe acute reactions when the interval between the two fractions per day is 4.5 hrs or less in comparison to intervals longer than 4.5 hrs.", "The optimal fractionation schedule for radiotherapy of head and neck cancer has been controversial. The objective of this randomized trial was to test the efficacy of hyperfractionation and two types of accelerated fractionation individually against standard fractionation.\n Patients with locally advanced head and neck cancer were randomly assigned to receive radiotherapy delivered with: 1) standard fractionation at 2 Gy/fraction/day, 5 days/week, to 70 Gy/35 fractions/7 weeks; 2) hyperfractionation at 1. 2 Gy/fraction, twice daily, 5 days/week to 81.6 Gy/68 fractions/7 weeks; 3) accelerated fractionation with split at 1.6 Gy/fraction, twice daily, 5 days/week, to 67.2 Gy/42 fractions/6 weeks including a 2-week rest after 38.4 Gy; or 4) accelerated fractionation with concomitant boost at 1.8 Gy/fraction/day, 5 days/week and 1.5 Gy/fraction/day to a boost field as a second daily treatment for the last 12 treatment days to 72 Gy/42 fractions/6 weeks. Of the 1113 patients entered, 1073 patients were analyzable for outcome. The median follow-up was 23 months for all analyzable patients and 41.2 months for patients alive.\n Patients treated with hyperfractionation and accelerated fractionation with concomitant boost had significantly better local-regional control (p = 0.045 and p = 0.050 respectively) than those treated with standard fractionation. There was also a trend toward improved disease-free survival (p = 0.067 and p = 0.054 respectively) although the difference in overall survival was not significant. Patients treated with accelerated fractionation with split had similar outcome to those treated with standard fractionation. All three altered fractionation groups had significantly greater acute side effects compared to standard fractionation. However, there was no significant increase of late effects.\n Hyperfractionation and accelerated fractionation with concomitant boost are more efficacious than standard fractionation for locally advanced head and neck cancer. Acute but not late effects are also increased.", "With the aim to increase the dose intensity of radiation therapy (RT), and subsequently the locoregional control rate, a very accelerated RT regimen was compared with conventional RT in a series of patients with head and neck squamous cell carcinoma (HNSCC).\n Between 1994 and 1998, 268 patients with T3 or T4, N0 to N3 HNSCC (staged by 1997 International Union Against Cancer criteria) that was not eligible for surgery were randomly assigned to receive either conventional RT, delivering 70 Gy in 7 weeks to the primary tumor and 35 fractions of 2 Gy over 49 days, or to receive very accelerated RT, delivering 62 to 64 Gy in 31 to 32 fractions of 2 Gy over 22 to 23 days (2 Gy/fraction bid).\n The most common tumor site was the oropharynx and most of the patients (70%) had T4 and N1 to N3 tumors in 72% of patients. The main patient and tumor characteristics were well-balanced between the two arms. The median total doses were 63 Gy (accelerated) and 70 Gy (conventional), with a median overall time of 22 days and 48 days, respectively. Acute mucositis was markedly increased in the accelerated-RT arm (P < .001). The locoregional control rate was improved by 24% at 6 years with accelerated RT. In contrast, disease-free survival and overall survival were not significantly different between the two arms. There was no difference in late effects between the two arms.\n The very accelerated RT regimen was feasible and provided a major benefit in locoregional control but had a modest effect on survival.", "Based on our demonstration of a circadian rhythm in the human oral mucosa cell cycle, with most cells in the G(1) phase in the morning and M phase at night, we hypothesized that morning radiotherapy (RT) would lead to less oral mucositis than afternoon RT.\n A total of 216 patients were randomized to morning (8-10 AM) vs. afternoon (4-6 PM) RT and stratified by radiation dose, smoking status, and center. Patients receiving primary or postoperative RT alone were eligible. Oral mucositis was scored using the Radiation Therapy Oncology Group (RTOG) criteria and a validated scoring system.\n Of 205 evaluable patients, 52.9% vs. 62.4% developed RTOG Grade 3 or greater mucositis after morning vs. afternoon RT, respectively (p = 0.17). Morning RT was also associated with significantly less weight loss after 5 months (p = 0.024). In a subgroup of 111 patients treated to a dose of 66-70 Gy in 33-35 fractions, exploratory analyses revealed a significant reduction in Grade 3 or greater mucositis with morning RT (44.6% vs. 67.3%, p = 0.022) and a longer interval to the development of Grade 3 or greater mucositis (median, >7.9 vs. 5.6 weeks, p = 0.033). In 53 patients, who smoked during therapy, a significant reduction was found in Grade 3 or greater mucositis with morning RT (42.9% vs. 76%, p = 0.025).\n In this proof of principle study, morning RT was associated with significantly less weight loss after 5 months and an apparent reduction in oral mucositis in a subset of patients receiving >/=66 Gy and in patients who smoked during therapy.", "To compare the efficacy of fast-neutron radiotherapy with that of conventionally fractionated photon therapy in the management of patients with locally advanced squamous cell carcinoma of the head and neck.\n Patients with Stage III or IV disease were randomized to receive either 20.4 Gy/12 fractions/4 weeks of neutrons or 70 Gy/35 fractions/7 weeks of photons (control). Between April 1986 and March 1991, 178 patients were entered, 169 of whom were eligible for analysis. The treatment arms were balanced for age, stage, and performance status, but not for primary site of origin.\n Complete response occurred in 70 and 52% with neutrons and photons, respectively (p = 0.006). Local regional failure at 3 years for all patients was 63% for neutrons and 68% for photons. Actuarial overall survival curves were virtually identical in both study arms, falling to 27% at 3 years. Acute toxicity was similar in the two arms, but late grade 3-5 toxicity was 40% with neutrons compared to 18% with photons (p = 0.008).\n Although the initial response rate was higher with neutrons, permanent local control and survival were not improved, and the incidence of late normal tissue toxicity was increased. As a result, fast-neutron therapy for advanced squamous cell carcinoma of the head and neck can only be recommended for patients in whom the logistic benefit of treatment in 12 sessions over 4 weeks outweighs the increased risk of late toxicity.", "The aims of this randomized controlled trial were to determine whether there were differences in the disease-free survival (DFS) and toxicity between conventional radiotherapy (CRT) and a continuous 3 week accelerated radiotherapy regimen (ART) in stage III and IV squamous cell carcinoma of the oral cavity, oropharynx, larynx and hypopharynx.\n Patients from 14 centres throughout Australia and New Zealand were randomly assigned to either CRT, using a single 2 Gy/day to a dose of 70 Gy in 35 fractions in 49 days or to ART, using 1.8 Gy twice a day to a dose of 59.4 Gy in 33 fractions in 24 days. Treatment allocation was stratified for site and stage. The accrual began in 1991 and the trial was closed in 1998 when the target of 350 patients was reached.\n The median potential follow-up time was 53 months (range, 14-101). The DFS at 5 years was 41% (95% CI, 33-50%) for ART and 35% (95% CI, 27-43%) for CRT (P=0.323) and the hazard ratio was 0.87 in favour of ART (95% CI, 0.66-1.15). The 5-year disease-specific survival rates were 40% for CRT and 46% for ART (P=0.398) and the loco-regional control was 47% for CRT vs. 52% for ART (P=0.300). The respective hazard ratios were 0.88 (95% CI, 0.65-1.2) and 0.85 (0.62-1.16), favouring the accelerated arm. In the ART arm, confluent mucositis was more severe (94 vs. 71%; P<0.001) and peaked about 3 weeks earlier than in the CRT arm, but healing appeared complete in all cases. There were statistically significant reductions in the probability of grade 2 or greater late soft tissue effects over time in the ART arm (P<0.05), except for the mucous membrane where late effects were similar in both arms.\n Differences in DFS, disease-specific survival and loco-regional control have not been demonstrated. ART resulted in more acute mucosal toxicity, but this did not result in greater prolongation of the treatment time compared with the CRT arm. There were less late effects in the ART arm, with the exception of late mucosal effects. This trial has confirmed that tumour cell repopulation occurs during conventionally fractionated radiotherapy for head and neck cancer. However, it has also provided additional evidence that overall improvements in the therapeutic ratio using accelerated fractionation strategies are seriously constrained by the need to limit total doses to levels that do not exceed acute mucosal tolerance. The accelerated schedule tested has been shown in this trial to be an acceptable alternative to conventionally fractionated irradiation to 70 Gy.", "To determine whether, in the postoperative setting, accelerated fractionation (AF) radiotherapy (RT) yields a superior locoregional control rate compared with conventional fractionation (CF) RT in locally advanced squamous cell carcinomas of the oral cavity, oropharynx, larynx, or hypopharynx.\n Patients from four institutions with one or more high-risk features (pT4, positive resection margins, pN >1, perineural/lymphovascular invasion, extracapsular extension, subglottic extension) after surgery were randomly assigned to either RT with one daily session of 2 Gy up to 60 Gy in 6 weeks or AF. Accelerated fractionation consisted of a \"biphasic concomitant boost\" schedule, with the boost delivered during the first and last weeks of treatment, to deliver 64 Gy in 5 weeks. Informed consent was obtained. The primary endpoint of the study was locoregional control. Analysis was on an intention-to-treat basis.\n From March 1994 to August 2000, 226 patients were randomized. At a median follow-up of 30.6 months (range, 0-110 months), 2-year locoregional control estimates were 80% +/- 4% for CF and 78% +/- 5% for AF (p = 0.52), and 2-year overall survival estimates were 67% +/- 5% for CF and 64% +/- 5% for AF (p = 0.84). The lack of difference in outcome between the two treatment arms was confirmed by multivariate analysis. However, interaction analysis with median values as cut-offs showed a trend for improved locoregional control for those patients who had a delay in starting RT and who were treated with AF compared with those with a similar delay but who were treated with CF (hazard ratio = 0.5, 95% confidence interval 0.2-1.1). Fifty percent of patients treated with AF developed confluent mucositis, compared with only 27% of those treated with CF (p = 0.006). However, mucositis duration was not different between arms. Although preliminary, actuarial Grade 3+ late toxicity estimates at 2 years were 18% +/- 4% and 27% +/- 6% for CF and AF, respectively (p = 0.10).\n Accelerated fractionation does not seem to be worthwhile for squamous cell carcinoma of the head and neck after resection; however, AF might be an option for patients who delay starting RT.", "A randomised phase II trial was initiated to explore the feasibility of concomitant cisplatin and radiotherapy with conventional fractionation (CF) or multiple fractions per day (MFD) for patients with locally advanced head and neck malignancies. The MFD schedule was designed to achieve higher tumour concentrations of cisplatin at the time of irradiation by reducing the number of radiation treatment weeks from 7 to 3, allowing recovery from side-effects of both irradiation and cystostatic drugs during the rest periods, while keeping the same total dose and overall treatment time. Patients were randomised between a conventional fractionation scheme (CF) of 70 Gy in 7 weeks with 2 Gy per fraction with a daily dose of 6 mg/m(2) cisplatin and a modified fractionation scheme (MFD) delivering three fractions of 1.6 Gy per day, in weeks 1, 4 and 7, keeping the same overall treatment time and total dose. In the modified treatment regime, a daily dose of 10 mg/m(2) cisplatin was administered. 53 patients were entered in this trial and radiotherapy was given according to the schedule to all patients in both treatment arms. Cisplatin was given during the whole course of radiotherapy to only one quarter of the patients in the CF arm, stopping mostly after 5-6 weeks due to bone marrow depression and kidney toxicity, while patients in the MFD arm received it according to schedule. No difference was observed in acute and late toxicity in both treatment arms, while a similar or even better tumour response was obtained with MFD. A 67% higher daily dose of cisplatin concomitant with irradiation could be given in a 3-week multiple fractionation per day schedule, as opposed to the cisplatin given in the conventional daily fractionation schedule of 7 weeks with the same total radiation dose. Similar acute and late toxicities were seen in both treatment arms.", "nan", "EORTC protocol 22791 compared once daily fractionation (CF) of 70 Gy in 35-40 fractions in 7-8 weeks, to pure hyperfractionation (HF) of 80.5 Gy in 70 fractions in 7 weeks using 2 fractions of 1.15 Gy per day, in T2-T3 oropharyngeal carcinoma (excluding base of tongue), N0,N1 of less than 3 cm. From 1980 to 1987, 356 patients were entered. In the final analysis (June 1990), the local control was significantly higher (p = 0.02 log-rank) after HF compared with CF. At 5 years, 59% of patients are local disease-free in the HF arm compared to 40% in the CF arm. The superiority of HF was demonstrated in patients staged T3N0,T3N1 but not in T2. The Cox model confirmed that the treatment regimen was an independent significant prognostic factor for locoregional control (p = 0.007 log-rank). This improvement of locoregional control was responsible for a trend to an improved survival (p = 0.08 log-rank). There was no difference in late normal tissue damage between the two treatment modalities.", "nan", "nan", "Forty patients with advanced, unresectable squamous cell carcinomas of the head and neck were entered on a prospective, randomized study comparing fast neutron radiation therapy with conventional photon radiation therapy. Twenty-six patients were randomized to neutrons, and 14 patients were randomized to photons. The randomization was purposefully unbalanced in favor of the experimental treatment. The complete response rate for the neutron-treated group of patients was 52%. The complete response rate for the photon-treated group of patients was 17%. The difference is statistically significant at the p = .04 level. The two-year survival rates for the neutron-treated group and the photon-treated group were 25 and 0%, respectively. The major complication rates were not statistically significantly different for the two groups (18% for neutrons, and 33% for photons).", "Radiation therapy is often the primary treatment for advanced cases of head and neck cancers not considered suitable for radical surgery. In these cases locoregional tumour control rates are low and has warranted innovative treatment modifications, such as altered fractionation schedules and combination with chemotherapy.\n From October 1990 to December 1997, 239 patients with squamous cell cancers originating in the head and neck region were randomized to one of three treatment options. Standard therapy consisting of conventional fractionation with 70 Gy in 7 weeks in 35 fractions (CF). The second treatment option consisted of a continuous hyperfractionated accelerated radiotherapy delivering a total dose of 55.3 Gy in 33 fractions over 17 consecutive days (V-CHART). The third study arm had identical fractionation and dose as the above accelerated treatment, with the additional administration of 20 mg/m(2) mitomycin C (MMC) on day 5 of treatment (V-CHART+MMC).\n Main toxicity resulted from accelerated fractionation in confluent mucositis (Grade 3-4 in 95%) requiring nasogastral tube feeding, analgetics and antiphlogistics in the majority of cases. Haematological toxicity Grade 3-4 was seen after MMC administration in 18%. MMC administration did not influence mucosal reaction. Overall duration of mucositis was not different in the three treatment groups. Loco-regional tumour control was 31% after CF, 32% after V-CHART and 48% after V-CHART+MMC, respectively (P<0.05). Overall crude survival was 24% after CF, 31% following V-CHART and 41% after V-CHART+MMC, respectively (P<0.05). Median follow up was 48 months (assessment performed in February 1999).\n Following shortening overall treatment time from 7 weeks to 17 consecutive days and dose of radiotherapy from 70 to 55.3 Gy the results in the radiotherapy only treated patients are identical. A significant improvement regarding local tumour control and survival was seen following administration of MMC to the accelerated fractionated treatment.", "Three hundred and twenty-seven patients with inoperable squamous cell carcinomas of the head and neck were entered on a randomized study comparing a mixture of neutron and photon (\"mixed beam\") radiation therapy with photon/electron radiation therapy. Neutron treatment was delivered with fixed-beam, physics-laboratory-based equipment. Patients with histologically proven tumors of T-stage T2, T3, or T4 and any N-stage were eligible for randomization. Primary tumor sites were limited to cancers originating in the oral cavity, oropharynx, supraglottic larynx, or hypopharynx. Patients entered on this study now have a minimum at-risk follow-up period of 6 years. Study results reveal no significant differences in overall loco-regional tumor control rates or survival. Subgroup analysis reveals significant differences based on whether or not patients presented with positive lymph nodes. Loco-regional tumor control rates for patients presenting with positive lymph nodes were 30% for mixed-beam-treated patients versus 18% for photon-treated patients (p = 0.05). Loco-regional tumor control rates for patients presenting without positive lymph nodes were 64% for photon-treated patients and 33% for mixed-beam-treated patients (p = 0.004). Control of tumor located in the nodal sites favored mixed beam over photons by a margin of 45% (49/109) to 26% (23/87) with a significance of p = 0.004. Possible explanations for these contradictory findings are discussed.", "The Radiation Therapy Oncology Group conducted a prospective comparison of a compensated split course radiotherapy technique (300 cGy x 10, 3 weeks rest, 300 cGy x 10), versus continuous radiotherapy (200-220 cGy up to 6000-6600 cGy), in 137 evaluable patients. The complete response (CR) was 57% in 63 patients, treated with the split-technique vs 61% in 74 patients submitted to continuous course radiotherapy. The completion of therapy as planned was better in the split-technique, but acute and late tissue reactions were the same. Locoregional control of tumor at 5 years was 25% for split and 28% for continuous therapy. At 7 years this was 25% and 24%, respectively. Absolute survival in the split-course patients tended to be lower than in the continuous group, but when the sample of patients was enlarged by the addition of cases from similar trials of nasopharynx and base of tongue lesions, the survival difference was eliminated. On the basis of the results of this study we conclude that the stated compensated split-course technique gives equal clinical results as conventional continuous therapy, with the advantage of requiring fewer radiation fractions, and less burden on the patient and therapy facilities.", "Patients with untreated squamous cell cancer of the head and neck region were randomized to receive either a boost of 25-30 Gy using photon-beam irradiation (photons) or an equivalent boost using neutron-beam irradiation (neutrons). All patients received an initial 45-50 Gy of wide-field photon irradiation. A total of 57 patients was evaluable on the neutron arm and 58 were evaluable on the photon arm. The proportion of patients with complete responses was 60 and 64% on the neutron and photon arms, respectively. The locally disease-free proportion at 2 years was estimated to be 20 and 31%, and the 2-year survival was estimated to be 32 and 41%, respectively. These differences are not statistically significant. There was a higher rate of severe complications on the neutron arm, 16 versus 7%. Thus, there was no evidence that a neutron boost produces better initial tumor clearance, local tumor control, or survival than a photon boost, and it may produce more complications.", "To update 5-year results of a previously published study on special 7-days-a-week fractionation continuous accelerated irradiation (CAIR) for head-and-neck cancer patients.\n One hundred patients with squamous cell carcinoma of head and neck in Stage T(2-4)N(0-1)M(0) were randomized between two definitive radiation treatments: accelerated fractionation 7 days a week including weekends (CAIR) and conventional 5 days a week (control). Hence the overall treatment time was 2 weeks shorter in CAIR.\n Five-year local tumor control was 75% in the CAIR group and 33% in the control arm (p < 0.00004). Tumor-cure benefit corresponded with significant improvement in disease-free survival and overall survival rates. Confluent mucositis was the main acute toxicity, with the incidence significantly higher in CAIR patients than in control (respectively, 94% vs. 53%). When 2.0-Gy fractions were used, radiation necrosis developed in 5 patients (22%) in the CAIR group as a consequential late effect (CLE), but when fraction size was reduced to 1.8 Gy no more CLE occurred. Actuarial 5-year morbidity-free survival rate was similar for both treatments.\n Selected head-and-neck cancer patients could be treated very effectively with 7-days-a-week radiation schedule with no compromise of total dose and with slight 10% reduction of fraction dose (2 Gy-1.8 Gy), which article gives 1 week reduction of overall treatment time compared with standard 70 Gy in 35 fractions over 47-49 days. Although this report is based on the relatively small group of patients, its results have encouraged us to use CAIR fractionation in a standard radiation treatment for moderately advanced head-and-neck cancer patients.", "Two hundred forty-eight patients with primary epidermoid carcinoma of the oral cavity, oropharynx, and hypopharynx, stages II, III, and IV were entered into a prospective randomized clinical trial of preoperative irradiation therapy (700 rads X 2) and surgery versus surgery alone. At 5 years both groups had a similar survival when analyzed according to stage of disease, primary site, or lymph node status. However, the group of patients receiving preoperative irradiation showed a lower incidence of local recurrence (22% versus 36%) preoperative irradiation showed a lower incidence of local recurrence (22% versus 36%) (P = 0.02). From this study we conclude that preoperative irradiation in this dose schedule has little influence on the ultimate outcome after surgical treatment of head and neck cancer.", "Early mobile tongue cancer can be controlled with interstitial radiotherapy (ISRT). We carried out a Phase III trial to compare the treatment results of low-dose-rate (LDR) ISRT and high-dose-rate (HDR) ISRT for early mobile tongue cancer.\n From April 1992 through October 1996, 59 patients with cancer of the early mobile tongue were registered in this Phase III study. Eight patients were excluded from the evaluation because of violations of the requirements for this study. Of 51 eligible patients, 26 patients were treated with LDR-ISRT (70 Gy/4-9 days) and 25 patients with HDR-ISRT (60 Gy/10 fractions/1 week). For the hyperfractionated HDR-ISRT, the time interval between 2 fractions was more than 6 h.\n Five-year local control rates of the LDR and HDR groups were 84% and 87% respectively. Nodal metastasis occurred in 6 patients in each group. Five-year nodal control rates of the LDR and HDR groups were 77% and 76%, respectively.\n Hyperfractionated HDR-ISRT for early mobile tongue cancer has the same local control compared with continuous LDR-ISRT. Hyperfractionated HDR-ISRT is an alternative treatment for continuous LDR-ISRT.", "A 5 week-hyperfractionated and accelerated radiotherapy regimen without reduction of the total dose was developed to fight tumour repopulation during treatment and tumour hypoxia. The purpose of the study was to try to improve loco-regional control in high risk head and neck carcinoma treated with curative radiotherapy.\n From 1985 to 1995, a randomised controlled trial of the EORTC Cooperative Group of Radiotherapy (EORTC 22851) compared the experimental regimen (72 Gy/45 fractions/5 weeks) to standard fractionation and overall treatment time (70 Gy/35 fractions/7 weeks) in T2, T3 and T4 head and neck cancers (hypopharynx excluded). The end-point criteria were local and loco-regional control, overall and disease-free survival, and acute and late toxicities. Five hundred twelve patients were accrued.\n Patients in the AF (accelerated fractionation) arm did significantly better with regard to loco-regional control (P = 0.02) resulting at 5 years in a 13% gain (95% CI 3-23% gain) in loco-regional control over the CF (conventional fractionation) arm. This improvement is of larger magnitude in patients with poorer prognosis (N2-3 any T, T4 any N) than in patients with more favourable stage. Multivariate analysis confirmed AF as an independent prognostic factor of good prognosis for loco-regional control (P = 0.03). Specific survival shows a trend (P = 0.06) in favour of the AF arm. ACUTE AND LATE TOXICITIES: Acute and late toxicity were increased in the AF arm. Late severe functional irradiation damage occurred in 14% of patients of the AF arm versus 4% in the CF arm. Two cases of radiation-induced myelitis occurred after doses of 42 and 48 Gy to the spinal cord.\n This trial shows that accelerated radiotherapy improves loco-regional control in head and neck squamous cell carcinomas. A less toxic scheme should, however, be investigated and documented before using accelerated radiotherapy as a standard regimen of curative radiotherapy for head and neck cancers.", "A prospective, randomized Phase Ilate/II trial of hyperfractionated radiation therapy was conducted: 1.2 Gy minimum tumor dose was administered twice daily with a minimum interval of 4 hr, 5 days per week. Patients with Stage III and IV carcinomas of the oral cavity, oropharynx, nasopharynx, hypopharynx, and supraglottic larynx were stratified by site, presence or absence of nodal metastases, and performance status. They were assigned to four total doses between 67.2 Gy and 81.6 Gy to all known tumors. The highest dose arm was opened after preliminary assessment indicated acceptable late morbidity rates with the three lower doses. Of 479 patients entered, 260 patients were randomized to the three lower total doses and 237 were analyzed for this preliminary report: 63 were assigned to receive 67.2 Gy, 58 to 72.0 Gy, and 116 to 76.8 Gy. Estimates of grade 4 necrosis at 2 years were 10.0%, 5.1%, and 13.9%, respectively, for patients who received total doses of 67.2 Gy, 72.0 Gy, and 76.8 Gy. There was a suggestion of a trend toward increased local control at 24 months (Kaplan-Meier estimates of 25% for 67.2 Gy, 37% for 72.0 Gy, and 42% for 76.8 Gy) (p = .08). No difference was observed in survival. Assessment of the results using Cox regression models to correct for slight inequalities of pretreatment prognostic variables supported a total dose-tumor control relationship (p = .054). Results for the lowest dose arm were comparable to previous RTOG studies of common fractionation with similar total doses. The higher local control rates with 72.0 and 76.8 Gy using hyperfractionated radiation therapy suggest an improvement in outcome with radiation therapy for advanced carcinomas of the upper aerodigestive tracts. These preliminary findings have led to a Phase III comparison of hyperfractionated radiation therapy with 1.2 Gy b.i.d. with standard fractionation.", "Short-course, high fractional dose radiation therapy was compared with the conventional protracted radiation schedule in the treatment of advanced (stages III and IV) head and neck cancer. Sixty-four patients with surgically unresectable squamous cell carcinoma were randomized to receive either 6,000 to 7,000 rad in six to seven weeks or 4,000 to 4,800 rad in two to three weeks. The palliative benefits of irradiation were comparable in the two treatment arms, and complete tumor regression was observed in the majority of patients in both groups. There was no difference between the groups with regard to either short-term normal tissue radiation reaction or long-term complications. High fractional dose irradiation appears to yield results equivalent to those of conventionally fractionated radiation therapy in advanced head and neck cancer and deserves further study both as primary treatment and in combination with surgery.", "From April 1986 to May 1989, 112 patients seen at a single institution with previously untreated squamous cell oropharynx carcinoma, Stages III and IV, were randomly assigned to 66 Gy in 33 fractions of 2 Gy each (conventional RT) versus 70.4 Gy in 64 fractions of 1.1 Gy given twice a day with a minimal interfraction interval of 6 hours (hyperfractionated RT). The overall time for both arms was 6 1/2 weeks. Patients were stratified by site (base of the tongue vs others), T stage (T1/T2 vs T3 vs T4), N stage (N0/N1 vs N2 vs N3), and lymphnode size (less than 6 cm vs greater than 6 cm). As of January 1990, an analysis was performed in 98 patients (8 patients in the conventional arm and 6 in the hyperfractionation not included). The groups were balanced by age, performance status, stage, and site of the primary disease. The median follow-up time was 25 months. The probability of complete loco-regional response was 62% in the hyperfractionation arm and 52% for the conventional fractionation (p = 0.28). There was no difference in the control of lymphnodal disease (hyperfractionated = 55%, conventional = 57%; p = 0.92), but the disease control in the oropharynx only was significantly improved in the hyperfractionation arm (84% vs 64%, p = 0.02). Overall survival rate at 42 months was 27% for the hyperfractionation arm and 8% for the conventional (p = 0.03). Survival rates for hyperfractionated versus conventional RT were 40% versus 18% (p = 0.06), respectively, for Stage III patients and 16% versus 0% (p = 0.15), respectively, for Stage IV. There was significant improvement in survival in favor of the hyperfractionation arm in patients with lesions outside the base of the tongue (31% vs 15%, p = 0.02), for those with a 50-70% Karnofsky status (19% vs 0%, p = 0.006) and for patients with N0/N1 disease (38% vs 15%, p = 0.03). Acute toxicities were of similar magnitude, although both skin and mucosal reactions appeared earlier on the hyperfractionation scheme. To date, no differences in late toxicity have been observed. We conclude that in a subset group of patients with locally advanced carcinoma of the oropharynx, hyperfractionated radiotherapy appears to provide improved survival without adding to increased toxicity.", "To compare neutron treatment and megavoltage (photon) radiotherapy in locally advanced squamous cell carcinoma of the head and neck.\n Randomised trial of patients stratified by site of primary tumour and presence or absence of lymph node metastases. Follow up of patients after treatment.\n Department of clinical oncology, Western General Hospital, Edinburgh.\n 165 Patients with untreated, histologically proved squamous cell carcinoma of the oral cavity, oropharynx, larynx, or hypopharynx. All patients completed treatment, and no patient was lost to follow up.\n Treatment with either neutrons or photons.\n Disease state and morbidity (scored with the system of the European Organisation for Research on Treatment of Cancer) at each visit during follow up.\n Of the 165 patients, 85 were randomised to receive neutron treatment and 80 to receive photon treatment. Minimum follow up was five years. Local control of cancer remained similar in the two groups, being achieved in 37 (44%) patients after neutron treatment and 36 (45%) after photon treatment. Five year and actuarial 10 year survival rates were 24% (20/85) and 14% respectively in the group treated with neutrons and 34% (27/80) and 30% respectively in the group treated with photons. Five year survival rates without local disease were 19% (16/85) and 30% (24/80) respectively. Necrosis was more common after neutron treatment than after photon treatment. Seven patients in the neutron group who developed necrosis died whereas no deaths were associated with photon treatment.\n Rates of long term local control were similar in the two groups. Necrosis related to radiation was more common in patients treated with neutrons, and the mortality related to treatment was significantly higher in these patients.", "To compare conventional fractionation radiation therapy (RT), Arm A, vs. split-course accelerated hyperfractionated RT (S-AHF), Arm B, vs. conventional fractionation RT plus concomitant chemotherapy (CT), Arm C, in terms of survival and toxicity for advanced, unresectable epidermoid tumors of oropharynx.\n Between January 1993 and June 1998, 192 previously untreated patients affected with Stage III and IV oropharyngeal carcinoma (excluding T1N1 and T2N1) were accrued in a multicenter, randomized Phase III trial (ORO 93-01). For Arms A and C, 66-70 Gy in 33-35 fractions, 5 days a week, were administered in 6.5-7 weeks to tumor and positive nodes. In Arm B, the dose delivered to tumor and involved nodes was 64-67.2 Gy, giving 2 fractions of 1.6 Gy every day with an interfraction interval of at least 4 h and preferably 6 h, 5 days a week. At 38.4 Gy, a 2-week split was planned; after the split, RT was resumed with the same modality. In Arm C, CT regimen consisted of carboplatin and 5-fluorouracil (CBDCA 75 mg/m(2), Days 1-4; 5-FU 1,000 mg/m(2) i.v. over 96 h, Days 1-4, recycling every 28 days (at 1st, 5th, and 9th week).\n No statistically significant difference was detected in overall survival (p = 0.129): 40% Arm A vs. 37% Arm B vs. 51% Arm C were alive at 24 months. Similarly, there was no statistically significant difference in terms of event-free survival (p = 0.196): 20% for Arm A, 19% for Arm B, and 37% for Arm C were event free at 24 months. On the contrary, the 2-year disease-free survival was significantly different among the three arms (p = 0.022), with a superiority for Arm C. At 24 months, the proportion of patients without relapse was 42% for Arm C vs. 23% for Arm A and 20% for Arm B. Patients in Arm A less frequently developed G3+ acute mucositis than their counterparts in Arm B or C (14.7% vs. 40.3% vs. 44%). Regarding the CT-related acute toxicity, apart from 1 case of fatal nephrotoxicity, only hematologic G3+ (Grade 3 or higher) acute sequelae were observed (World Health Organization scale), most commonly leukopenia (22.7%). Arm C showed slightly more G3+ skin, s.c. tissue, and mucosal late side effects (RTOG scale), although significant sequelae were relatively uncommon, and mucosal sequelae were most commonly transient. The occurrence of persistent G3 xerostomia was comparable in all three treatment arms.\n The combination of simultaneous CT and RT with the regimen of this trial is better than RT alone in advanced oropharyngeal squamous-cell carcinomas, by increasing disease-free survival. This improvement, however, did not translate into an overall survival improvement, and was associated with a higher incidence of acute morbidity.", "To test the efficacy of an accelerated fractionation schedule (concomitant boost) against standard conventional fractionation in squamous cell carcinomas of the head and neck region in our patient population.\n Patients were randomised to receive either conventional radiotherapy with 2 Gy/fraction/day, to a dose of 66 Gy in 33 fractions over 6.5 weeks or accelerated radiotherapy in the form of concomitant boost to a dose of 67.5 Gy/40 fractions over 5 weeks (phase 1: 45 Gy/25 fractions/5 weeks and phase 2: 22.5 Gy/15 fractions/3 weeks as a second daily fraction after a 6h gap). The primary and secondary end points were disease-free survival and locoregional control respectively.\n The compliance was 97.2% and 96.5% in the concomitant boost and conventional arms, respectively. Patients treated with concomitant boost had a better 2-year disease-free survival (71.7% vs 52.17%, P=0.0007) and locoregional control rates (73.6% vs 54.5%, P=0.0006) than with conventional fractionation. On exploratory subgroup analysis, the oropharynx (P<0.001), T4 lesions (P=0.017), N+ disease (P<0.001) and stage IV disease (P<0.001) were statistically significant prognostic variables in favour of the concomitant boost arm. Grade 3 mucositis was seen in 35% of patients in the concomitant boost arm, whereas in the conventional arm only 19% of patients had grade 3 mucositis (P=0.01). The median radiotherapy duration in the concomitant boost arm was 36 days (range 36-53 days), whereas in the conventional arm it was 46 days (range 46-64 days). The mean gap in radiation treatment in the concomitant boost arm was 1.68 days (range 0-14 days), whereas the mean gap in the conventional arm was 1.58 days (range 0-14 days).\n Concomitant boost is a therapeutically superior and logistically feasible accelerated radiotherapy regimen in advanced head and neck cancers, especially in the setting of a developing country.", "A multi-institutional, prospective, randomized trial was undertaken in patients with advanced head-and-neck squamous cell carcinoma to address (1) the validity of using pathologic risk features, established from a previous study, to determine the need for, and dose of, postoperative radiotherapy (PORT); (2) the impact of accelerating PORT using a concomitant boost schedule; and (3) the importance of the overall combined treatment duration on the treatment outcome.\n Of 288 consecutive patients with advanced disease registered preoperatively, 213 fulfilled the trial criteria and went on to receive therapy predicated on a set of pathologic risk features: no PORT for the low-risk group (n = 31); 57.6 Gy during 6.5 weeks for the intermediate-risk group (n = 31); and, by random assignment, 63 Gy during 5 weeks (n = 76) or 7 weeks (n = 75) for the high-risk group. Patients were irradiated with standard techniques appropriate to the site of disease and likely areas of spread. The study end points were locoregional control (LRC), survival, and morbidity.\n Patients with low or intermediate risks had significantly higher LRC and survival rates than those with high-risk features (p = 0.003 and p = 0.0001, respectively), despite receiving no PORT or lower dose PORT, respectively. For high-risk patients, a trend toward higher LRC and survival rates was noted when PORT was delivered in 5 rather than 7 weeks. A prolonged interval between surgery and PORT in the 7-week schedule was associated with significantly lower LRC (p = 0.03) and survival (p = 0.01) rates. Consequently, the cumulative duration of combined therapy had a significant impact on the LRC (p = 0.005) and survival (p = 0.03) rates. A 2-week reduction in the PORT duration by using the concomitant boost technique did not increase the late treatment toxicity.\n This Phase III trial established the power of risk assessment using pathologic features in determining the need for, and dose of, PORT in patients with advanced head-and-neck squamous cell cancer in a prospective, multi-institutional setting. It also revealed the impact of the overall treatment time in the combination of surgery and PORT on the outcome in high-risk patients and showed that PORT acceleration without a reduction in dose by a concomitant boost regimen did not increase the late complication rate. These findings emphasize the importance of coordinated interdisciplinary care in the delivery of combined surgery and RT.", "To establish the feasibility of performing split-course accelerated hyperfractionation (AHFX-S) and concomitant boost accelerated fractionation radiotherapy (AFX-C) for advanced head and neck cancer in a multi-institutional cooperative trial setting and to evaluate the tumor clearance rate and acute and late toxicity of these fractionation schedules.\n Between February 1989 and January 1990, 75 patients with Stage III or IV squamous cell carcinoma of the head and neck were randomized to receive: (a) AHFX-S: 1.6 Gy/fraction, twice daily (6-h interval), 5 days/week, to a total dose of 67.2 Gy/42 fractions/6 weeks, with a 2-week rest after 38.4 Gy; or (b) AFX-C: 1.8 Gy/fraction/day, 5 daily fractions/week to 54 Gy/30 fractions/6 weeks to a large field and 1.5 Gy/fraction/day to a boost field, 6 h after large field treatment during the last 11 treatment days, to a total dose of 70.5 Gy/41 fractions/6 weeks. Acute and late toxicities were scored according to the RTOG normal tissue reaction scales and tumor clearance was evaluated at completion of therapy and at regular intervals thereafter.\n Of the 70 analyzable patients, 38 received AHFX-S and 32 received AFX-C. The two arms were balanced with respect to sex, age, T-stage, and Karnofsky Performance Status (KPS). However, the AHFX-S arm had a higher proportion of oropharyngeal primaries (63% vs. 44%), and Stage IV disease (82% vs. 50%) and lower proportion of oral cavity lesions (3% vs. 22%) and N0 disease (16% vs. 31%) than the AFX-C arm. The median follow-up was 2 years (range: 0.03-4.87 years). Tolerance of both variants of accelerated fractionated radiotherapy was satisfactory. There was no significant difference in local-regional control, disease-free survival, or survival between the two arms. The 2-year local-regional failure rate, survival, and disease-free survival was 50, 50, and 40%, respectively, for the entire group of patients. Acute radiation mucositis was increased in both arms. There was no significant difference in the incidence of grade 3 acute toxicities (63% vs. 56%) and grade 3 (14% vs. 14%) or grade 4 (6% vs. 17%) late toxicities. Permanent grade 4 late toxicity was observed in 6 and 7% of the patients, respectively.\n Results of this randomized Phase I/II trial showed that the two accelerated fractionated schedules studied can be successfully given in a multi-institutional cooperative trial. There was no significant difference in acute or late toxicities, local-regional control, disease-free survival, or survival in this small scale study. Therefore, a Phase III trial comparing the relative efficacy of these two accelerated fractionation schedules against standard fractionation and hyperfractionation has been activated." ]

[ "1540455", "8457045", "1424853", "8398512", "16492843" ]

[ "Hypoxaemia is reduced by pulse oximetry monitoring in the operating theatre and in the recovery room.", "Randomized evaluation of pulse oximetry in 20,802 patients: II. Perioperative events and postoperative complications.", "Pulse oximetry in the postoperative care of cardiac surgical patients. A randomized controlled trail.", "Perioperative monitoring with pulse oximetry and late postoperative cognitive dysfunction.", "The impact of continuous pulse oximetry monitoring on intensive care unit admissions from a postsurgical care floor." ]

[ "To determine the impact of pulse oximeter monitoring on the incidence, severity and duration of hypoxaemia in the operating theatre (OT) and in the recovery room (RR), we investigated 200 patients in a randomized study. The extent of hypoxaemia in the OT was compared with that in the RR. Adult inpatients were allocated randomly to two groups: group I, pulse oximeter data and alarms \"available\"; group II, these data \"unavailable\" to the anaesthesia team and RR staff. Hypoxaemia was graded into four values of oxyhaemoglobin saturation (SpO2). The incidence of hypoxaemia was reduced significantly in group I in both OT and RR. In the OT, five patients in group II suffered SpO2 less than 76% compared with none in group I (P less than 0.02). In group II in the RR, seven patients suffered SpO2 less than 81%; three of these had SpO2 less than 76%. No patients in group I exhibited such small values of saturation. The smallest recorded SpO2 in the OT and the RR was significantly greater in group I. The cumulative duration of hypoxaemia was significantly less in group I in the RR, but not in the OT. The incidence and severity of hypoxaemia in the OT and in the RR were comparable, whereas the cumulative duration of hypoxaemia was significantly greater in the RR than in the OT. The occurrence of hypoxaemia in an individual patient in the OT significantly increased this patient's risk of suffering hypoxaemia in the RR. We conclude that the extent of hypoxaemia, especially in the RR, may be reduced significantly by pulse oximeter monitoring, but even with the information provided, some patients still develop hypoxaemia.", "The authors describe the effect of pulse oximetry monitoring on the frequency of unanticipated perioperative events, changes in patient care, and the rate of postoperative complications in a prospective randomized study.\n The study included 20,802 surgical patients in Denmark randomly assigned to be monitored or not with pulse oximetry in the operating room (OR) and postanesthesia care unit (PACU).\n During anesthesia and in the PACU, significantly more patients in the oximetry group had at least one respiratory event than did the control patients. This was the result of a 19-fold increase in the incidence of diagnosed hypoxemia in the oximetry group than in the control group in both the OR and PACU (P < 0.00001). In the OR, cardiovascular events were observed in a similar number of patients in both groups, except myocardial ischemia (as defined by angina or ST-segment depression), which was detected in 12 patients in the oximetry group and in 26 patients in the control group (P < 0.03). Several changes in PACU care were observed in association with the use of pulse oximetry. These included higher flow rate of supplemental oxygen (P < 0.00001), increased use of supplemental oxygen at discharge (P < 0.00001), and increased use of naloxone (P < 0.02). The rate of changes in patient care as a consequence of the oximetry monitoring increased as the American Society of Anesthesiologists physical status worsened (P < 0.00001). One or more postoperative complications occurred in 10% of the patients in the oximetry group and in 9.4% in the control group (difference not significant). The two groups did not differ significantly in cardiovascular, respiratory, neurologic, or infectious complications. The duration of hospital stay was a median of 5 days in both groups (difference not significant). An equal number of inhospital deaths were registered in the two groups. Questionnaires, completed by the anesthesiologists at the five participating departments, revealed that 18% of the anesthesiologists had experienced a situation in which a pulse oximeter helped to avoid a serious event or complication and that 80% of the anesthesiologists felt more secure when they used a pulse oximeter.\n This study demonstrated that pulse oximetry can improve the anesthesiologist's ability to detect hypoxemia and related events in the OR and PACU and that the use of the oximeter was associated with a significant decrease in the rate of myocardial ischemia. Although monitoring with pulse oximetry prompted a number of changes in patient care, a reduction in the overall rate of postoperative complications was not observed.", "To demonstrate the utility of pulse oximetry in detecting clinically unapparent episodes of arterial desaturation in postoperative cardiac surgical patients and to evaluate the effect of pulse oximetry on ordering arterial blood gas analyses.\n Prospective, randomized, partially blinded comparison.\n Cardiothoracic surgical intensive care unit.\n 35 patients following elective cardiac surgical procedures.\n All patients were monitored continuously with pulse oximetry throughout their ICU course. In group 1 patients, the SpO2 data were available at the bedside. In group 2 patients, the SpO2 data were masked at the bedside and monitored at a remote location.\n Utilization of pulse oximetry allowed a significant reduction in arterial blood gas utilization in group 1 (group 1: 12.4 +/- 7.5 blood gas analyses per ICU admission vs group 2: 23.1 +/- 8.8; p = 0.0007) without adverse events. Clinically unapparent desaturations were detected in 7 of 15 patients in group 2.\n Pulse oximetry improves patient safety through the detection of clinically unapparent episodes of desaturation and can allow a reduction in the number of blood gas analyses utilized without adverse effects to the patient. This may allow a potential cost savings to the patient.", "In a randomized, blinded clinical study, we have used objective and subjective measures to determine if perioperative monitoring with pulse oximetry--by virtue of its potential to lessen hypoxaemia--would decrease late postoperative cognitive dysfunction. We investigated 736 adult patients undergoing elective procedures (other than cardiac, neurosurgical or for cancer) under regional or general anaesthesia, allocated randomly to undergo (group I) or not to undergo (group II) pulse oximetry monitoring in the operating theatre and recovery room. Cognitive function was evaluated using the Wechsler memory scale (WMS) and continuous reaction time (RT) test the day before surgery, and on the 7th day after operation or at discharge if that occurred before postoperative day 7. A questionnaire sent 6 weeks after surgery elicited patients' subjective perceptions regarding cognitive abilities. There were no significant differences between the two groups in either the total WMS score, the score for each WMS subtests or RT test. The questionnaire revealed that 7% in group I and 11% in group II believed cognitive abilities had decreased (ns). For the 40 patients whose WMS scores were 10 points less after than before operation, a follow-up study was undertaken 3 months after surgery. At that time, the median WMS score had returned to the preoperative value. We conclude that, for these 736 patients, subjective and objective measures did not indicate less postoperative cognitive impairment after perioperative monitoring with pulse oximetry.", "Continuous pulse oximetry (CPOX) has the potential to increase vigilance and decrease pulmonary complications and thus decrease intensive care unit (ICU) admissions. In a randomized nonblinded study of 1219 subjects we compared the effects of CPOX and standard monitoring on the rate of transfer to an ICU from a 33-bed postcardiothoracic surgery care floor. There was no difference in the rate of ICU readmission between the CPOX and standard monitor groups. Despite older age and comorbidity, estimated cost to time of censoring (enrollment to completion of the study) was less in the monitored patients who required ICU transfer than in the unmonitored patients who required ICU transfer (mean estimated cost difference of 28,195 dollars; P = 0.04). Use of CPOX altered the reasons that patients were transferred to an ICU but did not affect the rate of transfer. The duration, and thus estimated cost, of ICU stay was significantly less in the CPOX-monitored group. The potential for CPOX to allow for early intervention, or perhaps prevention of pulmonary complications, needs to be explored. Routine CPOX monitoring did not reduce transfer to ICU, mortality, or overall estimated cost of hospitalization, and it is unclear if there is any real benefit from the application of this technology in patients on a general care floor who are recovering from cardiothoracic surgery." ]

[ "14758405", "15017805", "16032738", "15451744", "16507741", "12934722" ]

[ "Influence of pesticide regulation on acute poisoning deaths in Sri Lanka.", "Injuries in the Iowa Certified Safe Farm Study.", "Effects of premium discount on workers' compensation claims in agriculture in Finland.", "Impact of a national rural youth health and safety initiative: results from a randomized controlled trial.", "Efficacy of the North American guidelines for children's agricultural tasks in reducing childhood agricultural injuries.", "Prevention of farm injuries in Denmark." ]

[ "To assess in a developing Asian country the impact of pesticide regulation on the number of deaths from poisoning. These regulations, which were implemented in Sri Lanka from the 1970s, aimed to reduce the number of deaths - the majority from self-poisoning - by limiting the availability and use of highly toxic pesticides.\n Information on legislative changes was obtained from the Ministry of Agriculture, national and district hospital admission data were obtained from the Sri Lanka Health Statistics Unit, and individual details of deaths by pesticide poisoning were obtained from a manual review of patients' notes and intensive care unit records in Anuradhapura.\n Between 1986 and 2000, the total national number of admissions due to poisoning doubled, and admissions due to pesticide poisoning increased by more than 50%. At the same time, the case fatality proportion (CFP) fell for total poisonings and for poisonings due to pesticides. In 1991_92, 72% of pesticide-induced deaths in Anuradhapura were caused by organophosphorus (OP) and carbamate pesticides - in particular, the WHO class I OPs monocrotophos and methamidophos. From 1991, the import of these pesticides was reduced gradually until they were banned for routine use in January 1995, with a corresponding fall in deaths. Unfortunately, their place in agricultural practice was taken by the WHO class II organochlorine endosulfan, which led to a rise in deaths from status epilepticus - from one in 1994 to 50 in 1998. Endosulfan was banned in 1998, and over the following three years the number of endosulfan deaths fell to three. However, at the end of the decade, the number of deaths from pesticides was at a similar level to that of 1991, with WHO class II OPs causing the most deaths. Although these drugs are less toxic than class I OPs, the management of class II OPs remains difficult because they are, nevertheless, still highly toxic, and their toxicity is exacerbated by the paucity of available facilities.\n The fall in CFP amidst a rising incidence of self-poisoning suggests that Sri Lanka's programmes of pesticide regulation were beneficial. However, a closer inspection of pesticide-induced deaths in one hospital revealed switching to other highly toxic pesticides, as one was banned and replaced in agricultural practice by another. Future regulation must predict this switching and bear in mind the ease of treatment of replacement pesticides. Furthermore, such regulations must be implemented alongside other strategies, such as integrated pest management, to reduce the overall pesticide availability for self-harm.", "The aims of this article are to assess injury characteristics and risk factors in the Iowa Certified Safe Farm (CSF) program and to evaluate the effectiveness of CSF for reducing injuries. This intervention program includes a health screening, on-farm safety review, education, and monetary incentives. Cohorts of farmers in an intervention group (n = 152) and control group (n = 164) in northwestern Iowa were followed for a three-year period. During the follow-up, there were 318 injuries (42/100 person-years), of which 112 (15/100 person-years) required professional medical care. The monetary cost of injuries was $51,764 ($68 per farm per year). There were no differences in the self-reported injury rates and costs between the intervention and control groups. Raising livestock, poor general health, and exposures to dust and gas, noise, chemicals and pesticides, and lifting were among risk factors for injury. Most injuries in this study were related to animals, falls from elevation, slips/trips/falls, being struck by or struck against objects, lifting, and overexertion. Machinery was less prominent than generally reported in the literature. Hurry, fatigue, or stress were mentioned as the primary contributing factor in most injuries. These findings illustrate the need for new interventions to address a multitude of hazards in the farm work environment as well as management and organization of farm work.", "The objective of this study was to measure changes in injury claim rates after a premium discount program was implemented in the Finnish farmers' workers' compensation insurance. We focused on measures that could indicate whether the changes occurred in the true underlying injury rate, or only in claims reporting.\n Monthly injury claim rates were constructed at seven disability duration levels from January 1990 to December 2003. We conducted interrupted time series analyses to measure changes in the injury claim rates after the premium discount was implemented on July 1, 1997. Three additional policy change indicators were included in the analyses.\n The overall injury claim rate decreased 10.2%. Decreases occurred at four severity levels (measured by compensated disability days): 0 days (16.3%), 1-6 days (14.1%), 7-13 days (19.5%), and 14-29 days (8.4%). No changes were observed at higher severity levels. Minor injuries had a seasonal pattern with higher rates in summer months while severe injuries did not have a seasonal pattern.\n The premium discount decreased the overall claim rate. Decreases were observed in all categories up to 29 disability days. This pattern suggests that under-reporting contributes to the decrease but may not be the only factor. The value of the premium discount is lower than the value of a lost-time claim, so there was no financial reason to under-report lost-time injuries. Under-reporting would be expected to be greatest in the 0 day category, but that was not the case. These observations suggest that in addition to under-reporting, the premium discount may also have some preventive effect.\n Copyright (c) 2005 Wiley-Liss, Inc.", "We conducted a comprehensive evaluation of a rural youth health and safety initiative implemented in 4000 National FFA (formerly Future Farmers of America) chapters across the United States.\n Data were collected from high school students and their FFA advisers at 3 time intervals (preintervention, immediate postintervention, and 1 year postintervention) with a 3-group (standard, enhanced, and control), cluster-randomized, controlled trial design.\n Matched data from 3081 students and 81 advisers revealed no significant effect of this initiative on agricultural health and safety knowledge, safety attitudes, leadership, self-concept, and self-reported injuries of project participants. Data from 30 public health nurses following the intervention confirmed the program's failure to develop sustainable community partnerships.\n This nationally coordinated initiative was funded with more than $1 million donated by agribusinesses. Program implementation was inconsistent, and desired outcomes were not achieved. Future efforts should better guide effective use of private sector resources aimed at reducing agricultural disease and injury among rural youths.", "We assessed whether active dissemination of the North American Guidelines for Children's Agricultural Tasks (NAGCAT) reduced childhood agricultural injuries.\n In this randomized controlled trial, lay educators visited intervention farms to review NAGCAT. New York State farms with resident or working children were randomized. Control farms were visited only to collect baseline data. Data on childhood injuries, tasks, and hours worked were obtained quarterly for 21 months. Injury rates per farm were compared between the treatment and control groups, along with time span to occurrence of an injury and to violation of NAGCAT age guidelines.\n Intervention farms were less likely than control farms to violate NAGCAT age guidelines in the areas of all-terrain-vehicle use and tractor and haying operations. Cox proportional hazards regression models showed a significant protective effect of the intervention on preventable injuries after adjustment for important covariates.\n Our results showed that dissemination of NAGCAT reduced rates of work-related childhood agricultural injuries. A comprehensive public health approach is needed to reduce non-work-related childhood injuries.", "This study examined the effects of a 4-year randomized intervention program that combined a safety audit with safety behavior training in the prevention of farm injuries.\n From a random sample of farms in the county of Ringkoebing, Denmark, 393 farms with 1597 residents and employees participated in a weekly self-registration of work-related accidents and injuries during 1 year. Worktasks and time at risk were recorded. A questionnaire including items on safety behavior was also mailed to each farm. Thereafter, the farms were randomly assigned to an intervention or control group. Two hundred and one farms with 990 persons at risk participated in the intervention study. The main outcome measures were the number and severity of accidents, safety behavior, and farmsite safety audits.\n Pre- and postmeasurements showed a substantial reduction in injury rates in the intervention group in comparison with a slight reduction in the control group. In a multivariate regression analysis the intervention effect was estimated to be a 30% injury-rate reduction of all injuries, while there was a 42% reduction for medically treated injuries only. Although none of these effects are statistically significant with the present sample size, their magnitude and direction support an intervention effect. The measures of safety behavior revealed significant improvements, and this finding supports the conclusion that the intervention effect was positive, since they concern some of the mediating factors on the pathway from intervention to improved injury rates.\n This intervention, which focused on safety behavior and was performed as a randomized controlled trial, was followed by a substantial reduction in the number of farm injuries. The reduction was particularly marked for the more severe injuries demanding medical treatment." ]

[ "14976885", "15015440", "14571611" ]

[ "[Clinical study on treatment of severe acute respiratory syndrome with integrative Chinese and Western medicine approach].", "[Clinical study on treatment of severe acute respiratory syndrome by integrative Chinese and Western medicine].", "[Evaluation on effect of integrative medical treatment on quality of life of rehabilitation stage in 85 patients with SARS]." ]

[ "To summarize the clinical characteristics of severe acute respiratory syndrome (SARS) and observe the therapeutic effect with integrative Chinese and western medicine (ICWM) approach in treating patients with SARS.\n Forty-eight patients selected from the authors' hospital, whose diagnosis confirmed as SARS were analysed to sum-up the diagnostic type and basic feature of patients and the chief clinical characteristics. All the patients were randomly divided into the trial group and the control group, 24 in each. The control group was treated with the western medical therapeutic program and the trial group was treated with ICWM therapeutic program. The differences between the two groups were compared in terms of development of illness, time of using corticosteroid and absorption time of pulmonary inflammatory lesion, etc.\n Most patients were youth and adult aged between 18 to 40 years old, the initial symptom was mainly the high fever, accompanied with general soreness, chest stuffiness and cough, etc. The hospitalization time, body temperature fluctuation sustaining time and time of using corticosteroid in the trial group were shorter than those in the control group, showing significant difference (P < 0.05). ICWM treatment showed a better effect in defervescence and inflammatory lesion absorption time, but with no statistical significance.\n Patients of SARS are mainly youth and adults in the prime of life, fever always appears as the initiation of illness and some accompanying symptoms would appear. As compared with the western treatment, ICWM treatment could evidently shorten the course of illness, prevent the rebounding of fever and reduce the time of using corticosteroid.", "To evaluate the effect of integrative Chinese and western medicine (ICWM) in treating severe a cute respiratory syndrome (SARS).\n Sixty SARS patients were diagnosed and observed according to the universal standard, and divided into the ICWM group (n = 31, treated with ICWM) and the control group (n = 29, treated by conventional western medicine alone).\n ICWM showed better effect than that of western medicine alone in improving clinical symptoms, promoting the absorption of inflammation in lung, increased oxygen saturation (P < 0.01) and decreased the dosage of corticoid used (P < 0.05).\n The effect of ICWM is better than that of simple western medicine in treating SARS.", "To evaluate the effect of integrative medical treatment (IMT) with serial Chinese recipes on quality of life (QOF) of rehabilitation stage in SARS patients.\n Eighty-five SARS patients of rehabilitation stage were enrolled in the clinical study. They were divided into the IMT group (62 patients received serial Chinese recipes and western medicine) and the control group (23 patients received western medicine alone). The serial Chinese recipes were given according to patients' syndrome, one dose per day for oral intake for 3 weeks. QOF scoring in patients was observed.\n QOF scoring in the IMT group before treatment was not significantly different from that in the control group. After 3 weeks treatment, it improved to some extent in both groups, but the improvement in the IMT group was superior to that in the control group in respect of total score and score of psychologic emotional factors.\n Serial Chinese recipe could improve QOF of rehabilitation stage in SARS patients." ]

[ "18086944", "12540390", "21091250", "8901799", "15288885", "19064533", "16115337", "16379551", "16364832", "20147968", "12627188", "15175633", "20433527", "10714858" ]

[ "Lactotripeptides show no effect on human blood pressure: results from a double-blind randomized controlled trial.", "A fermented milk high in bioactive peptides has a blood pressure-lowering effect in hypertensive subjects.", "Hemodynamic effects of lactotripeptides from casein hydrolysate in Mediterranean normotensive subjects and patients with high-normal blood pressure: a randomized, double-blind, crossover clinical trial.", "A placebo-controlled study of the effect of sour milk on blood pressure in hypertensive subjects.", "Randomized controlled trial of sour milk on blood pressure in borderline hypertensive men.", "Enzymatically hydrolyzed lactotripeptides do not lower blood pressure in mildly hypertensive subjects.", "Antihypertensive effect of casein hydrolysate in a placebo-controlled study in subjects with high-normal blood pressure and mild hypertension.", "Effect of casein hydrolysate, prepared with protease derived from Aspergillus oryzae, on subjects with high-normal blood pressure or mild hypertension.", "Lactobacillus helveticus fermented milk lowers blood pressure in hypertensive subjects in 24-h ambulatory blood pressure measurement.", "The antihypertensive effect of fermented milk in individuals with prehypertension or borderline hypertension.", "Blood-pressure-lowering effect of a novel fermented milk containing gamma-aminobutyric acid (GABA) in mild hypertensives.", "Effect of ingesting sour milk fermented using Lactobacillus helveticus bacteria producing tripeptides on blood pressure in subjects with mild hypertension.", "The impact of lactotripeptides on blood pressure response in stage 1 and stage 2 hypertensives.", "Effect of administration of fermented milk containing whey protein concentrate to rats and healthy men on serum lipids and blood pressure." ]

[ "Milk-derived peptides with ACE-inhibiting properties may have antihypertensive effects in humans. We conducted a randomized double-blind placebo-controlled trial to examine the blood pressure lowering potential of 2 ACE-inhibiting lactotripeptides, ie, Isoleucine-Proline-Proline and Valine-Proline-Proline. We included 135 Dutch subjects with elevated systolic blood pressure who were otherwise healthy and who received no current antihypertensive treatment. After a 2-week run-in period on placebo, subjects randomly received a daily dose of 200 mL dairy drink with 14 mg lactotripeptides obtained by concentrating fermented milk, enzymatic hydrolysis, or chemical synthesis, or placebo for 8 weeks, followed by a 2-week wash-out. The primary outcome was 8-week change in office systolic blood pressure. Secondary outcomes were change in diastolic blood pressure, home blood pressure, 24-hour ambulatory blood pressure, plasma ACE-activity, and plasma angiotensin II. Blood pressure at baseline was on average 142/84 mm Hg. Lactotripeptides did not significantly change systolic blood pressure (P=0.46) or diastolic blood pressure (P=0.31) compared with placebo. The mean difference (95%-CI) in systolic blood pressure response between treatment and placebo was 2.8 mm Hg (-2.6;8.2) for concentrated fermented milk lactotripeptides, -0.5 mm Hg (-6.0;5.0) for enzymatic lactotripeptides, and 1.6 mm Hg (-3.9;6.9) for synthetic lactotripeptides. Treatment neither had a significant effect on secondary outcome measures. In conclusion, the present study does not support the hypothesis of a blood pressure lowering effect of the lactotripeptides Isoleucine-Proline-Proline and Valine-Proline-Proline.", "Angiotensin-converting enzyme (ACE; EC 3.4.15.1) plays a dual role in the regulation of hypertension: it catalyzes the production of the vasoconstrictor angiotensin II and it inactivates the vasodilator bradykinin. By inhibiting these processes, ACE inhibitors have antihypertensive effects. Peptides derived from milk proteins can have ACE-inhibiting properties and may thus be used as antihypertensive components.\n We evaluated the long-term blood pressure-lowering effect of milk fermented by Lactobacillus helveticus LBK-16H in hypertensive subjects.\n In a randomized placebo-controlled study, 39 hypertensive patients received 150 mL/d of either L. helveticus LBK-16H fermented milk or a control product for 21 wk after a 2-wk run-in period. During the run-in period, the average baseline diastolic and systolic blood pressure values were 155 and 97 mm Hg, respectively, in the test product group and 152 and 96 mm Hg, respectively, in the control group. After the run-in period, blood pressure was measured at home on the same day every week with the use of an automatic blood pressure recorder.\n There was a mean difference of 6.7 +/- 3.0 mm Hg in systolic blood pressure (P = 0.030) and of 3.6 +/- 1.9 mm Hg (P = 0.059) in diastolic blood pressure between the test product and control groups. Demographic factors had no significant effect on the responses.\n L. helveticus LBK-16H fermented milk containing bioactive peptides in normal daily use has a blood pressure-lowering effect in hypertensive subjects.", "Contrasting data partially support a certain antihypertensive efficacy of lactotripeptides derived from enzymatic treatment of casein hydrolysate. We carried out a randomized, double-blind, crossover clinical study to investigate the antihypertensive efficacy of a short-term treatment with lactotripeptides in Mediterranean subjects with normal or high-normal blood pressure (BP). We consecutively enrolled 55 untreated subjects (men:women = 30:25), 40.3 ± 9.8 years old, with normal or high-normal BP. After 4 weeks of dietary standardization, they were allocated to treatment with a fruit juice containing 3 mg of added Ile-Pro-Pro/Val-Pro-Pro lactotripeptides or with placebo for 4 weeks. After a 4-week washout period, they were then assigned to the alternative treatment for a further period of 4 weeks. Overall, no significant difference has been observed in office BP comparing baseline data with those posttreatment. Repeating the analysis by basal BP level, a mild but significant reduction in systolic BP (-1.7 ± 2.3 mm Hg; t = 3.5, P = .002) has been observed only in subjects with high-normal BP after treatment with lactotripeptides. With regard to 24-hour BP measurement, after lactotripeptide treatment only, the subjects experienced a significant reduction in diurnal diastolic BP (-1.6 ± 5.4 mm Hg; P = .042), diurnal mean BP (-2.1 ± 5.9 mm Hg; P = .19), and 24-hour (-5.4 ± 14.2 mm Hg; P = .011) and diurnal (-7.1 ± 19.2%; P = .014) diastolic BP value measurements relative to normal values. No modification has been observed in relation to plasma renin activity and aldosteronemia. In conclusion, diurnal diastolic BP is significantly reduced by lactrotripeptide supplementation in untreated Mediterranean subjects with normal or high-normal BP. Office systolic BP is reduced only in subjects with high-normal BP.", "A placebo-controlled study was conducted to test the effect of Calpis (Calpis Food Industry Co, Ltd, Tokyo, Japan) sour milk, i.e., a milk fermented with a starter containing Lactobacillus helveticus and Saccharomyces cerevisiae, on the blood pressure of 30 elderly hypertensive patients, most of whom were taking antihypertensive medication. Subjects were randomly assigned to two groups. One group ingested daily 95 mL of the sour milk for 8 wk, and the other group ingested the same amount of artificially acidified milk as a placebo for 8 wk. In the sour-milk group, systolic blood pressure decreased significantly 4 and 8 wk after ingestion, by 9.4 +/- 3.6 mm Hg (mean+/- SE, P < 0.05) and 14.1 +/- 3.1 mm Hg (P < 0.01), respectively. The diastolic blood pressure also decreased significantly, by 6.9 +/- 2.2 mm Hg (P < 0.01), by 8 wk after ingestion of the sour milk began. No significant changes in blood pressure were observed in the placebo group. The decrease in systolic and diastolic blood pressure in the sour-milk group tended to be greater than in the placebo group. No marked changes were observed in other indexes, including pulse rate, body weight, and blood serum variables in both groups.", "A double-blind randomized controlled trial was carried out to assess the effect of sour milk, containing two tripeptides (valine-proline-proline and isoleucine-proline-proline), on blood pressure (BP).\n A total of 46 borderline hypertensive men aged 23 to 59 years were recruited at their workplace for this trial. Subjects were randomly allocated into two groups; sour milk drink group (S-group, n = 23) and placebo (acidified milk) drink group (P-group, n = 23) for 4 weeks. Blood pressure was measured twice at each occasion by a physician, at the health center of the company, with a mercury at baseline, 2 and 4 weeks. Statistical analysis was performed by SPSS 10.0J.\n The S-group and P-group showed no significant difference in baseline systolic BP (mean [SD], S: 147.6 [9.6], P: 145.3 [13.0]) or diastolic BP (S: 95.3 [9.9], P: 91.5 [9.6]). In the S-group, change in systolic BP at 2 and 4 weeks were -4.3 mm Hg (95% confidence interval [CI] -8.3 to -0.4; P = .032) and -5.2 mm Hg (95% CI -10.1 to -0.3; P = .039), both statistically significant. Diastolic BP showed change from -1.7 mm Hg (95% CI -5.4 to 2.0) at 2 weeks and -2.0 (95% CI -5.4 to 1.5) at 4 weeks, respectively. In the P-group, change in systolic BP were -0.5 (95% CI -5.8 to 4.8) at 2 weeks and -3.7 (95% CI -8.3 to 0.9) and change in diastolic BP were -0.6 (95% CI -4.7 to 3.6) and -0.3 (95% CI -3.9 to 3.3), which were not statistically significant.\n This trial demonstrated the beneficial effect of sour milk on BP in borderline hypertensive men who were not taking antihypertensive medication.\n Copyright 2004 American Journal of Hypertension, Ltd.", "Several placebo-controlled clinical studies suggest that products containing isoleucyl-prolyl-proline and valyl-prolyl-proline are able to lower blood pressure without adverse effects. The most efficient way of producing high concentrations of these lactotripeptides (LTPs) is enzymatic hydrolysis of dairy protein (casein) with the use of a mixture of several enzymes derived from the nongenetically modified organism Aspergillus oryzae, including proteases and peptidases. To date, no large studies of the blood pressure-lowering properties of enzymatically produced LTP (ELTP) powder in European populations have been published.\n This study was performed to evaluate the hypothesis that consumption of ELTP in a yogurt beverage for 8 wk significantly lowers blood pressure.\n In this multicenter, double-blind, parallel, placebo-controlled trial, office blood pressure was evaluated in 275 Dutch hypertensive subjects. Blood pressures and body weight were measured on several days at baseline and at weeks 4 and 8 of the intervention between 2.5 and 3 h after intake of the test product. Twenty-four-h urine samples were collected at baseline and at the end of the intervention for urinalysis of sodium, potassium, creatinine, and microalbumin excretion.\n The results showed that 10.2 mg ELTP/d does not lead to a reduction in systolic blood pressure (P = 0.66) or diastolic blood pressure (P = 0.72) compared with placebo.\n This study showed no effect of an ELTP-enriched yogurt beverage on blood pressure in hypertensive subjects in a fairly large study.", "We describe a clinical trial to study the efficacy of a casein hydrolysate, prepared using an Aspergillus oryzae protease, containing the major angiotensin-I-converting enzyme inhibitory peptides Val-Pro-Pro (VPP) and Ile-Pro-Pro (IPP) in a single-blind, placebo-controlled study. A total of 131 volunteers with high-normal blood pressure and mild hypertension were randomly divided into four groups (n 32 or 33 in each group). Each volunteer was given two tablets containing four different dosages of VPP and IPP (VPP+IPP: 0, 1.8, 2.5 and 3.6 mg), daily for 6 weeks. A significant decrease in systolic blood pressure was observed at 6 weeks in the active group receiving 1.8 mg (P<0.01) VPP and IPP; in the active groups receiving either 2.5 mg or 3.6 mg, systolic blood pressure was decreased at both 3 weeks (P<0.05 and P<0.05) and 6 weeks (P<0.001 and P<0.0001) compared with systolic blood pressure measured before treatment. Changes in the systolic blood pressure after 6 weeks of treatment in the four groups were --1.7, --6.3, --6.7 and --10.1 mmHg, and these effects were dose dependent. In addition, a significant difference in systolic blood pressure between the placebo group and the VPP and IPP group receiving 3.6 mg was observed (P<0.001) by two-way ANOVA. The antihypertensive effect was greater in mildly hypertensive subjects (n 20 or 21 in each group) than in any of the other subjects. No significant change of diastolic blood pressure was observed for all the test groups, and no differences in diastolic blood pressure in the test sample groups compared with the placebo group were observed during the test period.", "Casein hydrolysate, prepared with Aspergillus oryzae protease, contains angiotensin I-converting enzyme inhibitory peptides, such as Val-Pro-Pro and Ile-Pro-Pro. We conducted a randomized, double-blind, placebo-controlled study to evaluate the effect of casein hydrolysate on the blood pressure of 144 subjects with high-normal blood pressure (n = 104) and mild hypertension (n = 40). Subjects were randomly assigned to two groups for a 12-week intake period. In the test group, both systolic (SBP) and diastolic (DBP) blood pressure decreased significantly compared with the placebo group: SBP/DBP significantly decreased from 138.2 +/- 6.5/84.4 +/- 5.3 mm Hg at week 0 to 132.3 +/- 7.3 (P < .001)/81.2 +/- 4.8 mm Hg (P < .001) at week 12. In the stratified analysis, the test product showed an antihypertensive effect in both the subject group with high-normal blood pressure and that with mild hypertension. No side effect was observed in any subjects in this study. These results demonstrate that the casein hydrolysate, prepared with A. oryzae protease, produced a significant reduction in blood pressure in a population of subjects with high-normal blood pressure or mild hypertension without an adverse event.", "The present study was carried out to evaluate the blood pressure (BP)-lowering effect and the safety aspects of Lactobacillus helveticus LBK-16H fermented milk with high tripeptide doses on hypertensive subjects using 24-h ambulatory measurements (ABPM).\n In a randomized, double blinded placebo-controlled parallel group study, 94 hypertensive patients not receiving any drug treatment were given 150 mL twice daily of either L. helveticus LBK-16H fermented milk with a high concentration of tripeptides (Ile-Pro-Pro 7.5 mg/100 g and Val-Pro-Pro 10 mg/100 g) or a control product, for 10 weeks after a 4-week run-in period. Twenty-four-hour ABPM were taken at the beginning and at the end of the intervention period. The average baseline systolic and diastolic BP values were 132.6 +/- 9.9/83.0 +/- 8.0 mm Hg in the L. helveticus group and 130.3 +/- 9.6 /80.2 +/- 7.0 mm Hg in the control group.\n There was a mean difference of -4.1 +/- 0.9 mm Hg in systolic (P = .001) and a -1.8 +/- 0.7 mm Hg in diastolic BP (P = .048) between the L. helveticus group and the control group. There was no difference in the sum of the adverse events (P = .820).\n Lactobacillus helveticus LBK-16H fermented milk containing bioactive peptides, in daily use, does have a BP-lowering effect in hypertensive subjects and is thus a potential for the dietary treatment of hypertension.", "Fermented milk (FM) with putative antihypertensive effect in humans could be an easy applicable lifestyle intervention against hypertension. The mode of action is supposed to be through active milk peptides, shown to possess in vitro ACE-inhibitory effect. Blood pressure (BP) reductions upto 23 mm Hg have been reported in spontaneously hypertensive rats fed FM. Results from human studies of the antihypertensive effect are inconsistent. However, many studies suffer from methodological weaknesses, as insufficient blinding and the use of office BP measurements. We conducted a randomised, double-blind placebo-controlled study of the antihypertensive effect of Lactobacillus helveticus FM in 94 prehypertensive and borderline hypertensive subjects. The participants were randomised into three treatment groups with a daily intake of 150 ml of FM, 300 ml of FM or placebo (chemically acidified milk). The primary outcome was repeated 24-h ambulatory BP measurements. There were no statistically significant differences in the outcome between the groups (systolic BP (SBP), P=0.9; diastolic BP (DBP), P=0.2). However, the group receiving 300 ml FM had reduced BP across the 8-week period in several readings, which could be compatible with a minor antihypertensive effect. Heart rate and lipids remained unchanged between groups. Hence, our study does not support earlier studies measuring office BP-measurements, reporting antihypertensive effect of FM. Based on straight performed 24-h ambulatory BP measurements, milk fermented with Lactobacillus helveticus does not posses significant antihypertensive effect.", "To study the effect of a new fermented milk product containing GABA (FMG) on the blood pressure (BP) of patients with mild hypertension.\n A randomized, placebo-controlled, single-blind trial.\n The study was carried out at the outpatient clinic of the Cardiovascular Disease Center, Tokyo Metropolitan Police Hospital, Japan.\n The study population comprised 39 mildly hypertensive patients (16 women and 23 men) aged 28-81 y (mean, 54.2 y).\n The study consisted of a 12-week period of daily intake of FMG or placebo (weeks 1-12) followed by 2 weeks of no intake (weeks 13 and 14). We measured the peripheral BP and heart rate of seated patients at weeks 0, 2, 4, 8, 12 and 14. Routine blood study and urinalysis were performed before and after the intake.\n There was a significant decrease of BP within 2 or 4 weeks, and it remained decreased throughout the 12-week intake period. For the FMG recipients, the mean decrease after 12 weeks was 17.4+/-4.3 mmHg in the systolic BP (SBP) and 7.2+/-5.7 mmHg in the diastolic BP (DBP). Both of these values differed statistically from baseline levels (P<0.01), and the SBP of the FMG group differed from the placebo group (P<0.05). Heart rate, body weight, hematological and blood chemistry variables, and urinalysis results (glucosuria and proteinuria) did not vary both groups throughout the study.\n FMG may contribute to lowering BP in mildly hypertensive people.", "Angiotensin-converting enzyme (ACE) is important in the regulation of blood pressure (BP). Two tripeptides that inhibit ACE, isoleucyl-prolyl-proline (Ile-Pro-Pro) and valyl-prolyl-proline (Val-Pro-Pro), have been isolated from certain sour milks. The aim of the study reported was to evaluate the effect on BP in subjects with mild hypertension of a new sour milk containing tripeptides. The initial number of subjects was 60 (36 men, 24 women). Among the criteria for inclusion in the study were systolic BP (SBP) between 140 and 180 mmHg and/or diastolic BP (DPB) between 90 and 110 mmHg, without antihypertensive drug therapy. There were two study periods with a washout period between. All subjects were given 1.5 dl per day of a placebo (regular sour milk) or of the active product, a milk that had been fermented with Lactobacillus helveticus bacteria and contained 2.4-2.7 mg of Ile-Pro-Pro and 2.4-2.7 mg of Val-Pro-Pro per 1.5 dl. In the first phase, SBP fell 16 mmHg from baseline in the active group, 2 mmHg more than in the placebo group (P=0.0668) and no difference in DBP (P=0.92). There was a statistically significant downward trend both in SBP and DBP (P=0.0001). During the second phase, SBP fell 11 mmHg in the active group (P=0.008). The reduction in SBP was significantly larger in active than placebo group (P=0.012). In the crossover analysis combining both phases, SBP fell on average 2.6+/-15.9 mmHg more on the active product compared with the placebo product, but this difference was not statistically significant (P=0.3111). The difference in DBP, 1.0+/-8.3 mmHg between the two test products was not significant either (P=0.4431). In conclusion, the ingestion of sour milk fermented by L. helveticus bacteria and that containing ACE inhibitory tripeptides seems to lower BP modestly.", "Nearly 70 million Americans have hypertension, and approximately an equal number have prehypertension. The prevalence of both disorders increases with advancing age and obesity. Many at-risk individuals do not have controlled blood pressure (BP). Lifestyle modification for most persons is the first step in a plan to control these conditions. Non-drug treatments offer an appeal to many patients with modest BP elevation. The authors recently evaluated BP response using 24-hour ambulatory BP monitoring and office BP monitoring of lactotripeptides dosed twice daily in 91 previously treated and treatment-naive patients with stage 1 and stage 2 hypertension. In this population, daytime systolic BP, the primary efficacy end point, significantly decreased (-3.6 mm Hg; P=.013), while placebo did not affect systolic BP (0 mm Hg; P=not significant). Treatment-naive patients exhibited a more robust drop in their daytime systolic BP (-7.6 mm Hg; P=.005) compared with placebo (-3.6 mm Hg; P=not significant). Lactotripeptides may be an effective agent in the management of low-risk and low-grade hypertension and prehypertension.", "The effect of fermented milk supplemented with whey protein concentrate on the serum lipid level of rats was investigated. The serum total cholesterol level for the group fed fermented milk with both Lactobacillus casei TMC0409 and Streptococcus thermophilus TMC 1543 was significantly lower than that of the control group (P<0.05) in rats. Furthermore, the effect of the longterm intake of this fermented milk on the serum lipid level of twenty healthy adult men was investigated. During the 8-wk study, the volunteers consumed 200 ml of fermented milk or placebo in the morning and evening. Blood samples were drawn for analysis three times, just before taking the experimental diet, and after 4 wk and 8 wk of consumption. After 8 wk, the high density lipoprotein cholesterol level for the fermented milk group showed a significant rise after 4 wk (P<0.05), whereas that of the placebo group showed no change even after 4 wk (P>0.05). The triglyceride level for the fermented milk group lowered significantly after 4 wk (<0.05), whereas that of the placebo group showed no change even after 4 wk (P>0.05). The atherogenic index [(total cholesterol - high density lipoprotein cholesterol)/high-density lipoprotein cholesterol] for the fermented milk group decreased significantly from 4.24 to 3.52 (P<0.05). The systolic blood pressure lowered significantly by the intake of fermented milk (P<0.05) On the other hand, such effect was not observed in the placebo group (P>0.05). These results indicate potential of the development of fermented milk with multiple therapeutic effects." ]

[ "10903230", "10766680", "10966244", "9476845" ]

[ "Noninvasive versus invasive microbial investigation in ventilator-associated pneumonia: evaluation of outcome.", "Invasive and noninvasive strategies for management of suspected ventilator-associated pneumonia. A randomized trial.", "Impact of quantitative invasive diagnostic techniques in the management and outcome of mechanically ventilated patients with suspected pneumonia.", "Impact of invasive and noninvasive quantitative culture sampling on outcome of ventilator-associated pneumonia: a pilot study." ]

[ "Noninvasive and invasive diagnostic techniques have been shown to achieve comparable performances in the evaluation of suspected ventilator-associated pneumonia (VAP). We studied the impact of both approaches on outcome in a prospective, open, and randomized study in three intensive care units (ICUs) of a 1,000-bed tertiary care university hospital. Patients with suspected VAP were randomly assigned to noninvasive (Group 1) versus invasive (Group 2) investigation (tracheobronchial aspirates [TBAS] versus bronchoscopically retrieved protected specimen brush [PSB] and bronchoalveolar lavage [BAL]. Samples were cultured quantitatively, and BAL fluid (BALF) was examined for intracellular organisms (ICO) additionally. Initial empiric antimicrobial treatment was administered following the guidelines of the American Thoracic Society (ATS) and adjusted according to culture results (and ICO counts in Group 2). Outcome variables included length of ICU stay and mechanical ventilation as well as mortality. Overall, 76 patients (39 noninvasive, 37 invasive) were investigated. VAP was microbiologically confirmed in 23 of 39 (59%) and 23 of 37 (62%) (p = 0.78). There were no differences with regard to the frequencies of community-acquired and potentially drug-resistant microorganisms (PDRM). Antimicrobial treatment was changed in seven patients (18%) of Group 1 and 10 patients (27%) of Group 2 because of etiologic findings (including five of 17 with ICO = 2% (p = not significant [NS]). Length of ICU stay and mechanical ventilation were also not significantly different in both groups. Crude 30-d mortality was 31 of 76 (41%), and 18 of 39 (46%) in Group 1 and 14 of 37 (38%) in Group 2 (p = 0.46). Adjusted mortality was 16% versus 11% (p = 0.53), and mortality of microbiologically confirmed pneumonia 10 of 23 (44%) in both groups (p = 1.0). We conclude that the outcome of VAP was not influenced by the techniques used for microbial investigation.", "Optimal management of patients who are clinically suspected of having ventilator-associated pneumonia remains open to debate.\n To evaluate the effect on clinical outcome and antibiotic use of two strategies to diagnose ventilator-associated pneumonia and select initial treatment for this condition.\n Multicenter, randomized, uncontrolled trial.\n 31 intensive care units in France.\n 413 patients suspected of having ventilator-associated pneumonia.\n The invasive management strategy was based on direct examination of bronchoscopic protected specimen brush samples or bronchoalveolar lavage samples and their quantitative cultures. The noninvasive (\"clinical\") management strategy was based on clinical criteria, isolation of microorganisms by nonquantitative analysis of endotracheal aspirates, and clinical practice guidelines.\n Death from any cause, quantification of organ failure, and antibiotic use at 14 and 28 days.\n Compared with patients who received clinical management, patients who received invasive management had reduced mortality at day 14 (16.2% and 25.8%; difference, -9.6 percentage points [95% CI, -17.4 to -1.8 percentage points]; P = 0.022), decreased mean Sepsis-related Organ Failure Assessment scores at day 3 (6.1+/-4.0 and 7.0+/-4.3; P = 0.033) and day 7 (4.9+/-4.0 and 5.8+/-4.4; P = 0.043), and decreased antibiotic use (mean number of antibiotic-free days, 5.0+/-5.1 and 2.2+/-3.5; P < 0.001). At 28 days, the invasive management group had significantly more antibiotic-free days (11.5+/-9.0 compared with 7.5+/-7.6; P < 0.001), and only multivariate analysis showed a significant difference in mortality (hazard ratio, 1.54 [CI, 1.10 to 2.16]; P = 0.01).\n Compared with a noninvasive management strategy, an invasive management strategy was significantly associated with fewer deaths at 14 days, earlier attenuation of organ dysfunction, and less antibiotic use in patients suspected of having ventilator-associated pneumonia.", "To assess how data obtained by invasive diagnostic techniques may affect management and outcome of patients with suspected ventilator-associated pneumonia (VAP), in comparison with noninvasive qualitative techniques.\n Prospective study.\n An 18-bed medical and surgical intensive care unit.\n A total of 91 patients suspected of having VAP were randomized into two groups. In group A (n = 45), quantitative cultures obtained by either bronchoscopic or nonbronchoscopic techniques were performed, whereas in group B (n = 43), patients were treated based on clinical judgment and nonquantitative tracheal aspirates cultures. Three patients were excluded because of the absence of follow-up.\n In patients with positive cultures, therapeutic changes were made in 20 patients. In four patients (three from group A and one from group B, p = NS), initial empirical antibiotic treatment was modified because the isolated microorganisms were not susceptible (all of them had late-onset pneumonia). The isolated organisms responsible for antibiotic modifications were methicillin-resistant Staphylococcus aureus (three patients) and Pseudomonas aeruginosa (one patient). In three patients, the antimicrobial therapy was considered inappropriate because the isolated microorganisms were multiresistant and treated with only one effective antibiotic. In 13 patients (ten from group A and three from group B, p < .05), treatment was changed to select a narrower spectrum antibiotic. No therapeutic modifications were made in patients with negative cultures based on the results of quantitative cultures. The overall mortality was 22.2% in group A and 20.9% in group B. There were no differences in intensive care unit stay or days of mechanical ventilation (23.67+/-3.15 vs. 22.42+/-3.01 and 19.99+/-2.88 vs. 19.24+/-3.04, respectively).\n In our study population, the routine use of quantitative invasive diagnostic tools is not justified in the setting of ventilated patients clinically suspected of having nosocomial pneumonia.", "We performed an open, prospective, randomized clinical trial in 51 patients receiving mechanical ventilation for more than 72 h, in order to evaluate the impact of using either invasive (protected specimen brush [PSB] and bronchoalveolar lavage [BAL] via fiberoptic bronchoscopy) or noninvasive (quantitative endotracheal aspirates [QEA]) diagnostic methods on the morbidity and mortality of ventilator-associated pneumonia (VAP). Patients were randomly assigned to two groups: Group A patients (n = 24) underwent QEA, PSB, and BAL; Group B patients (n = 27) underwent only QEA cultures. Empiric antibiotic treatment was given according to the attending physician and was modified according to the results of cultures and sensitivity in Group A using PSB and BAL results and in Group B based upon QEA cultures. Bacteriologic cultures were done quantitatively for EA, PSB, and BAL. Thresholds of > or = 10(5), > or = 10(3), and > or = 10(4) CFU/ml were used for QEA, PSB, and BAL, respectively. Microbial cultures from Group A patients were positive in 16 (67%) BAL samples, 14 (58%) PSB samples, and 16 (67%) QEA samples. In Group B patients, QEA microbial cultures yielded positive results in 20 of 27 (74%) samples. In Group A, there was total agreement between culture results of the three techniques on 17 (71%) occasions. In five (21%) cases, QEA coincided with either BAL or PBS. In only two (8%) cases, QEA cultures did not coincide with either PSB or BAL. No cases of positive BAL or PSB cultures had negative QEA cultures. Initial antibiotic treatment was modified in 10 (42%) patients from Group A and in four (16%) patients from Group B (p < 0.05). The observed crude mortality rate was 11 of 24 (46%) in Group A, and 7 of 27 (26%) in Group B, whereas the adjusted mortality rates (observed crude minus predicted at admission) for Groups A and B were 29 and 10%, respectively. There were no statistically significant differences when comparing crude and adjusted mortality rates of Groups A and B. There were no differences in mortality between both groups when comparing pneumonia, considering together Pseudomonas aeruginosa and Acinetobacter spp. (Group A, 33% versus Group B, 27%). There were no differences between Groups A and B with regard to ICU stay duration and total duration of mechanical ventilation. In this pilot study, the impact of bronchoscopy was to lead to more frequent antibiotic changes with no change in mortality. Further studies with larger population samples are warranted to confirm these findings." ]

[ "16485612", "15487477" ]

[ "[The effectiveness of body-oriented methods of therapy in the treatment of attention-deficit hyperactivity disorder (ADHD): results of a controlled pilot study].", "The effects of yoga on the attention and behavior of boys with Attention-Deficit/ hyperactivity Disorder (ADHD)." ]

[ "Randomized controlled studies on the effectiveness of body-oriented methods of treatment for children with attention-deficit hyperactivity disorder (ADHD) are lacking. Our aim was to compare the effectiveness of two methods of treatment (yoga for children vs. conventional motor exercises) in a randomized controlled pilot study.\n Nineteen children with a clinical diagnosis of ADHD (according to ICD-10 criteria) were included and randomly assigned to treatment conditions according to a 2x2 cross-over design. Effects of treatment were analyzed by means of an analysis of variance for repeated measurements.\n For all outcome measures (test scores on an attention task, and parent ratings of ADHD symptoms) the yoga training was superior to the conventional motor training, with effect sizes in the medium-to-high range (0.60-0.97). All children showed sizable reductions in symptoms over time, and at the end of the study, the group means for the ADHD scales did not differ significantly from those for a representative control group. Furthermore, the training was particularly effective for children undergoing pharmacotherapy (MPH).\n The findings from this pilot study demonstrate that yoga can be an effective complementary or concomitant treatment for attention-deficit hyperactivity disorder. The study advocates further research into the impact of yoga or body-oriented therapies on the prevention and treatment of ADHD.", "Boys diagnosed with ADHD by specialist pediatricians and stabilized on medication were randomly assigned to a 20-session yoga group (n = 11) or a control group (cooperative activities; n = 8). Boys were assessed pre- and post-intervention on the Conners' Parent and Teacher Rating Scales-Revised: Long (CPRS-R:L & CTRS-R:L; Conners, 1997), the Test of Variables of Attention (TOVA; Greenberg, Cormna, & Kindschi, 1997), and the Motion Logger Actigraph. Data were analyzed using one-way repeated measures analysis of variance (ANOVA). Significant improvements from pre-test to post-test were found for the yoga, but not for the control group on five subscales of the Conners' Parents Rating Scales (CPRS): Oppositional, Global Index Emotional Lability, Global Index Total, Global Index Restless/Impulsive and ADHD Index. Significant improvements from pre-test to post-test were found for the control group, but not the yoga group on three CPRS subscales: Hyperactivity, Anxious/Shy, and Social Problems. Both groups improved significantly on CPRS Perfectionism, DSM-IV Hyperactive/ Impulsive, and DSM-IV Total. For the yoga group, positive change from pre- to post-test on the Conners' Teacher Rating Scales (CTRS) was associated with the number of sessions attended on the DSM-IV Hyperactive-Impulsive subscale and with a trend on DSM-IV Inattentive subscale. Those in the yoga group who engaged in more home practice showed a significant improvement on TOVA Response Time Variability with a trend on the ADHD score, and greater improvements on the CTRS Global Emotional Lability subscale. Results from the Motion Logger Actigraph were inconclusive. Although these data do not provide strong support for the use of yoga for ADHD, partly because the study was under-powered, they do suggest that yoga may have merit as a complementary treatment for boys with ADHD already stabilized on medication, particularly for its evening effect when medication effects are absent. Yoga remains an investigational treatment, but this study supports further research into its possible uses for this population. These findings need to be replicated on larger groups with a more intensive supervised practice program." ]

[ "17697416", "16353851", "6202993", "17981847", "6083819", "20935327", "6184453", "10229456", "2666745", "14657447", "466329", "17691578", "2453399", "9210109", "7263934", "11441210", "21978210", "7356821", "8741982", "21239366", "17159119", "6173512", "16705846", "18647729" ]

[ "Intensive language training in the rehabilitation of chronic aphasia: efficient training by laypersons.", "Mapping therapy for sentence production impairments in nonfluent aphasia.", "Effectiveness of speech therapy for aphasic stroke patients. A randomised controlled trial.", "A prospective, randomized, parallel group, controlled study of the effect of intensity of speech and language therapy on early recovery from poststroke aphasia.", "Effects of speech and language treatment on recovery from aphasia.", "Efficacy of early cognitive-linguistic treatment and communicative treatment in aphasia after stroke: a randomised controlled trial (RATS-2).", "Treatment of acquired aphasia: speech therapists and volunteers compared.", "The efficacy of group communication treatment in adults with chronic aphasia.", "Home treatment for aphasic patients by trained nonprofessionals.", "Effects of semantic treatment on verbal communication and linguistic processing in aphasia after stroke: a randomized controlled trial.", "Comparative trial of volunteer and professional treatments of dysphasia after stroke.", "[Clinical treatment of apoplectic aphemia with multi-needle puncture of scalp-points in combination with visual-listening-speech training].", "Methods to assess aphasic stroke patients.", "The efficacy of computer-provided reading treatment for chronic aphasic adults.", "The efficacy of gestural cueing in dysphasic word-retrieval responses.", "Constraint-induced therapy of chronic aphasia after stroke.", "Very early poststroke aphasia therapy: a pilot randomized controlled efficacy trial.", "Language recovery in aphasia: effect of systematic filmed programmed instruction.", "Remediation of sentence processing deficits in aphasia using a computer-based microworld.", "Oral reading for language in aphasia (ORLA): evaluating the efficacy of computer-delivered therapy in chronic nonfluent aphasia.", "Rehabilitation of limb apraxia improves daily life activities in patients with stroke.", "Veterans Administration cooperative study on aphasia: a comparison of individual and group treatment.", "The TCM-combined treatment for aphasia due to cerebrovascular disorders.", "Design and methods of a randomized controlled trial on early speech and language therapy in patients with acute stroke and aphasia." ]

[ "Intense language training has been found to be more efficient in the rehabilitation of chronic aphasia than treatment spread across time. Intense treatment, however, challenges personnel and financial resources of the health care system. The present study examined, whether laypersons can be trained to apply standardized language training for chronic aphasia with effects comparable to training by experts. Twenty individuals with chronic aphasia participated in the training, Constraint-Induced Aphasia Therapy (CIAT), which comprises communicative language games with increasing level of difficulty in a motivating context for 3 hr/day on 10 consecutive days. Following a random-control design, training was applied either by experienced therapists (n=10) or trained laypersons (n=10). Standardized language assessments revealed significant within-group improvements, however, between-group differences were not present. We conclude that a standardized training program, such as CIAT, can be efficiently accomplished by trained laypersons with results comparable to that of experienced therapists.", "This study investigated a new treatment in which sentence production abilities were trained in a small group of individuals and nonfluent aphasia. It was based upon a mapping therapy approach which holds that sentence production and comprehension impairments are due to difficulties in mapping between the meaning form (thematic roles) and the syntactic form of sentences. We trained production of both canonical and noncanonical reversible sentences. Three patients received treatment and two served as control participants. Patients who received treatment demonstrated acquisition of all trained sentence structures. They also demonstrated across-task generalisation of treated and some untreated sentence structures on two tasks of constrained sentence production, and showed some improvements on a narrative task. One control participant improved on some of these measures and the other did not. There was no noted improvement in sentence comprehension abilities following treatment. Results are discussed with reference to the heterogeneity of underlying impairments in sentence production impairments in nonfluent patients, and the possible mechanisms by which improvement in sentence production might have been achieved in treatment.", "Aphasic stroke patients were randomly allocated to either a speech therapy group receiving treatment twice a week for 24 weeks or a no-treatment control group. Patients in both groups improved and there were no significant differences in language recovery between the 104 patients allocated to the treatment group and the 87 allocated to the no-treatment group. This treatment regimen, which is representative of clinical practice, is ineffective for most aphasic stroke patients.", "To examine whether the amount of speech and language therapy influences the recovery from poststroke aphasia.\n A hospital stroke unit and community.\n A prospective, randomized controlled trial.\n Aphasic stroke patients were randomly allocated to receive 5 hours (intensive therapy group, n=51) or 2 hours (standard therapy group) of speech and language therapy per week for 12 consecutive weeks starting as soon as practicable after the stroke. Another 19 patients were recruited for 2 hours per week of therapy and were treated by National Health Service (NHS) staff (NHS group). OUTCOME MEASURE AND ASSESSMENT: The Western Aphasia Battery. Assessments were made blind to randomization at baseline and 4, 8, 12 and 24 weeks after the start of therapy. Data were analysed by intention to treat.\n The mean (SD) Western Aphasia Battery score at week 12 for the intensive, standard and NHS groups was 70.3 (26.9), 66.2 (26.2) and 58.1 (33.7), respectively. There was no treatment effect of intensive therapy (P > 0.05), but there was a statistically significant difference between the standard study and the NHS groups (P = 0.002 at week 12 and 0.01 at week 24).\n Intensive speech and language therapy (as delivered in this study) did not improve the language impairment significantly more than the ;standard' therapy which averaged 1.6 hours/week. The improvement in aphasia was least in patients who were in the NHS group. These patients received 0.57 (0.49) hours of therapy per week.", "Language recovery in aphasic patients who received one of three types of speech and language treatment was compared with that in aphasic patients who received no treatment. One hundred aphasic patients were followed from 2 to 4 weeks postonset for 1 year or until recovery, using a standardized test battery administered at systematic intervals. Both treatment methods provided by trained speech-language pathologists were efficacious, while the method provided by trained nonprofessionals approached statistical significance. Small group size prevented resolution of the question of whether one type of treatment was superior to another.", "The two main approaches in aphasia treatment are cognitive-linguistic treatment (CLT), aimed at restoring the linguistic levels affected, semantics, phonology or syntax, and communicative treatment, aimed at optimising information transfer by training compensatory strategies and use of residual language skills. The hypothesis that CLT is more effective than communicative treatment in the early stages after stroke was tested in this study.\n In this multicentre, randomised, parallel group trial with blinded outcome assessment, 80 patients with aphasia after stroke were included within 3 weeks post-stroke. Patients received 6 months of CLT, comprising semantic and/or phonological training, or communicative treatment for at least 2 h per week. They were assessed before treatment and at 3 and 6 months with the Amsterdam-Nijmegen Everyday Language Test (ANELT-A, primary outcome) and semantic and phonological tests (secondary outcomes). The intervention effect was evaluated by means of analysis of covariance, with adjustment for baseline scores.\n There was no difference between the mean ANELT-A score of the CLT group (n=38) and the communicative treatment group (n=42), at 3 months (adjusted difference 1.5, 95% CI -2.6 to 5.6) or at 6 months (adjusted difference 1.6, 95% CI -2.3 to 5.6) post-stroke. On two of six specific semantic and phonological tests, the mean scores differed significantly, both in favour of CLT.\n This study does not confirm the hypothesis that patients with aphasia after stroke benefit more from CLT, aimed at activation of the underlying semantic and phonologic processes, than from general, non-specific communicative treatment (ISRCTN67723958 Current Controlled Trials).", "This paper reports on a multicentre trial comparing the effects of speech therapists and untrained volunteers on recovery from aphasia following stroke. One hundred and fifty-five patients entered the study and 96 completed it. Patients in both treatment groups improved, and there were no differences overall in the amount of progress made. A small subgroup of patients who started treatment much later had equivalent initial scores and made almost as much progress as those who started earlier. It is suggested that the improvement in communication which occurred during treatment may be due both to the appropriate stimulation which was based on detailed and accurate speech therapy assessment, and to the regular support and encouragement provided within the therapeutic relationship.", "We examined the effects of group communication treatment on linguistic and communicative performance in adults with chronic aphasia. Participants were randomly assigned to two treatment and two deferred treatment groups. Groups were balanced for age, education level, and initial aphasia severity. Twenty-four participants completed the 4-month treatment trial. While in the treatment condition, all participants received 5 hours of group communication treatment weekly, provided by a speech-language pathologist. The focus of treatment included increasing initiation of conversation and exchanging information using whatever communicative means possible. While awaiting group communication treatment, participants in the deferred treatment groups engaged in such activities as support, performance, or movement groups in order to control for the effects of social contact. Linguistic and communicative measures were administered to all participants at entry, after 2 and 4 months of treatment, and following 4 to 6 weeks of no treatment. In addition, participants in the deferred treatment groups received an additional administration of all measures just before their treatment trial. Results revealed that participants receiving group communication treatment had significantly higher scores on communicative and linguistic measures than participants not receiving treatment. In addition, significant increases were revealed after 2 months of treatment and after 4 months of treatment. No significant decline in performance occurred at time of follow-up.", "Thirty-seven aphasic men received 8-10 hr of individual treatment each week for 12 weeks from a home therapist (wife, friend, relative) who was trained and directed by a speech pathologist. Treatment was followed by 12 weeks of no treatment. Patients were evaluated at entry and at 6, 12, 18, and 24 weeks after entry with a battery of speech and language measures. The group made substantial progress on all measures during the 12 weeks of treatment and ceased to progress when treatment was discontinued. Progress for the home treatment patients did not differ significantly from that of patients who received 12 weeks of individual treatment from speech pathologists or from that of patients for whom treatment was deferred for 12 weeks. Patient selection, training of the home therapists, and other methodological aspects are described to assist speech pathologists in making decisions about the use of trained volunteers in aphasia treatment.", "Semantic deficits, deficits in word meaning, have a large impact on aphasic patients' verbal communication. We investigated the effects of semantic treatment on verbal communication in a randomized controlled trial.\n Fifty-eight patients with a combined semantic and phonological deficit were randomized to receive either semantic treatment or the control treatment focused on word sound (phonology). Fifty-five patients completed pretreatment and posttreatment assessment of verbal communication (Amsterdam Nijmegen Everyday Language Test [ANELT]). In an on-treatment analysis (n=46), treatment-specific effects on semantic and phonological measures were explored.\n Both groups improved on the ANELT, with no difference between groups in overall score (difference, -1.1; 95% confidence interval [CI], -5.3 to 3.1). After semantic treatment, patients improved on a semantic measure (mean improvement, 2.9; 95% CI, 1.2 to 4.6), whereas after phonological treatment, patients improved on phonological measures (mean improvement, 3.0; 95% CI, 1.4 to 4.7, and 3.0; 95% CI, 1.2 to 4.7).\n No differences in primary outcome were noted between the 2 treatments. Our findings challenge the current notion that semantic treatment is more effective than phonological treatment for patients with a combined semantic and phonological deficit. The selective gains on the semantic and phonological measures suggest that improved verbal communication was achieved in a different way for each treatment group.", "A study of the treatment of dysphasia after stroke compared the progress of two groups of disabled patients. One received conventional treatment from qualified speech therapists and the other from non-professional volunteers. Methods of assessing communication difficulties were also compared and the impact of aphasic illness on families examined. No important differences in the results of treatment were seen between the two groups. The volunteers, however, often had to assume some of the responsibilities of social workers, and transport to hospital created practical and economic problems. It is concluded that the two forms of treatment provide essentially the same benefit, although doubt must still remain because relatively few patients were studied.", "To observe the therapeutic effect of cluster-needle stimulation of scalp-points combined with rehabilitation training for apoplectic aphemia.\n A total of 56 outpatients were randomized into control (medication, manicol/ beronald, Ca2+ antagonist, citicoline, etc.) group. rehabilitation (Rehab, visual-listening, articulation and speech training) group and acupuncture [Dingqu: 1 cun and 2 cun parallel to the line joining Baihui (GV 20) and Qianding (GV 21) respectively on the bilateral sides. Dingqianqu: 1 cun and 2 cun parallel to the line joining GV21 and Xinghui (GV 22) separately on both sides. etc] combined with rehabilitation (Acup+ Rehab) group. Aphasia Battery of Chinese (ABC) was used to assess the patient's speech ability, i.e., aphasia quocient (AQ); The Chinese functional communication (CFCP) test was used to evaluate the patient's daily life speech communication ability, and Boston Diagnostic Aphasia Examination (BDAE) was also conducted to assess the severity of aphasia.\n After the treatment, the speech ability, oral presentation, listening comprehension, writing ability, AQ index and CFCP were all improved significantly in 3 groups (P < 0.005, 0.01); the total effective rate (85.00%) of Acup+ Rehab group was significantly higher than those of Rehab group (77.78%) and control group (64.71%, P < 0.05, 0.01). The scores of ABC, AQ index, CFCP and BDAE grade in Acup+ Rehab group were significantly higher than those of Rehab and control groups (P < 0.05, 0.01), and those scores of Rehab group were also significantly higher than those of control group (P < 0.05, 0.01).\n The cluster-needle puncture of scalp-points combined with rehabilitation training is an effective therapy for improving apoplectic aphemia.", "nan", "We examined the effects of computer-provided reading activities on language performance in chronic aphasic patients. Fifty-five aphasic adults were assigned randomly to one of three conditions: computer reading treatment, computer stimulation, or no treatment. Subjects in the computer groups used computer 3 hours each week for 26 weeks. Computer reading treatment software consisted of visual matching and reading comprehension tasks. Computer stimulation software consisted of nonverbal games and cognitive rehabilitation tasks. Language measures were administered to all subjects at entry and after 3 and 6 months. Significant improvement over the 26 weeks occurred on five language measures for the computer reading treatment group, on one language measure for the computer stimulation group, and on none of the language measures for the no-treatment group. The computer reading treatment group displayed significantly more improvement on the Porch Index of Communicative Ability \"Overall\" and \"Verbal\" modality percentiles and on the Western Aphasia Battery Aphasia \"Quotient\" and \"Repetition\" subtest than the other two groups. The results suggest that (a) computerized reading treatment can be administered with minimal assistance from a clinician, (b) improvement on the computerized reading treatment tasks generalized to non-computer language performance, (c) improvement resulted from the language content of the software and not stimulation provided by a computer, and (d) the computerized reading treatment we provided to chronic aphasic patients was efficacious.", "The effectiveness of visual--gestural cueing as compared with traditional auditory--verbal cueing was investigated using a time-series design. Eight dysphasic adults equally divided into a control and an experimental group were the subjects for this study. Results indicated no significant improvement in response times after an intensive 2-wk treatment period. Similarly, no single cue was observed to be more effective than others in eliciting dysphasic word-retrieval responses. In contrast, there was a significant difference in the order in which different cues were presented. Findings indicated that regardless of cue type, the cue presented first was the most effective. The present discussion relates current findings to previous observations and reviews implications of the data for language rehabilitation in dysphasia.", "Patients with chronic aphasia were assigned randomly to a group to receive either conventional aphasia therapy or constraint-induced (CI) aphasia therapy, a new therapeutic technique requiring intense practice over a relatively short period of consecutive days. CI aphasia therapy is realized in a communicative therapeutic environment constraining patients to practice systematically speech acts with which they have difficulty. Patients in both groups received the same amount of treatment (30 to 35 hours) as 10 days of massed-practice language exercises for the CI aphasia therapy group (3 hours per day minimum; 10 patients) or over a longer period of approximately 4 weeks for the conventional therapy group (7 patients). CI aphasia therapy led to significant and pronounced improvements on several standard clinical tests, on self-ratings, and on blinded-observer ratings of the patients' communicative effectiveness in everyday life. Patients who received the control intervention failed to achieve comparable improvements. Data suggest that the language skills of patients with chronic aphasia can be improved in a short period by use of an appropriate massed-practice technique that focuses on the patients' communicative needs.", "Early stroke rehabilitation has shown benefits over spontaneous recovery. Insufficient evidence exists to determine the benefits of early aphasia intervention. We hypothesized that daily aphasia therapy would show better communication outcomes than usual care (UC) in early poststroke recovery.\n This prospective, randomized, single-blinded, controlled trial was conducted in three acute-care hospitals in Perth, Australia, each with over 200 stroke admissions annually. Patients with acute stroke causing moderate to severe aphasia were recruited at a median of three-days (range: 0-10 days) to receive daily aphasia therapy or usual care therapy. Individually tailored, impairment-based intervention was provided for the acute hospital stay or intervention phase (median: 19 days; range: 5-76). Primary outcome measures were the aphasia quotient and functional communication profile at acute hospital discharge or four-weeks poststroke, whichever came first. A random-number generator and sealed envelopes were used to randomize participants. Assessments were completed by a blinded assessor.\n Fifty-nine participants were recruited, with six withdrawals (10%) and seven deaths (12%) at six-months. Ninety percent had ischemic strokes, with 56·5% experiencing a total anterior circulation stroke. The group mean (± SD) age was 69·1 (± 13·9) years. Six participants (18·75%) in the daily aphasia therapy group did not complete the minimum (150 min) therapy required for this study. The daily aphasia therapy intervention phase mean therapy session time was 45 min (range: 30-80) and the total mean amount of therapy for the daily aphasia therapy participants was 331 min (range: 30-1415). Four (15%) participants in the usual care group received therapy. The collective total therapy provided to these participants was 295 min over seven sessions. Usual care participants received an average of 10·5 min of therapy per week during the intervention phase. At the primary end point, a generalized estimating equations model demonstrated that after controlling for initial aphasia severity, participants receiving daily aphasia therapy scored 15·1 more points (P = 0·010) on the aphasia quotient and 11·3 more points (P = 0·004) on the functional communication profile than those receiving usual care therapy.\n Daily aphasia therapy in very early stroke recovery improved communication outcomes in people with moderate to severe aphasia.\n © 2011 The Authors. International Journal of Stroke © 2011 World Stroke Organization.", "This project investigated the effect of systematic filmed programmed instruction on language recovery of aphasic subjects with markedly disturbed communication skills. Fourteen male veterans between 32 and 69 years of age who had suffered cerebrovascular accidents were randomly assigned to an experimental or control group of 7 patients each. All subjects had completed elementary school; the majority had attended high school and several had attended college. Each subject was receiving and continued to receive speech therapy. In addition, the experimental subjects received supplementary filmed programmed instruction while the control group viewed slides, attended bibliotherapy and engaged in other nonprogrammed, activity. Each subject submitted to pretests, midtests, posttests of reading recognition and comprehension, figure background, visual learning, visual closure, and vocabulary. Study of the results and statistical analysis of the data did not show significant improvement either due to speech therapy or filmed programmed instruction for these subjects. The results of this project cannot be generalized because of limitations of number, subject categories, widespread time since onset, and for the experimental group, the filmed material utilized.", "Byng (1988) has argued that some aphasic patients who show problems in sentence comprehension are unable to \"map\" a syntactic analysis of the sentence form onto the thematic roles specified by the verb or preposition in the sentence. In Byng's study, therapy aimed at improving the mapping process as applied to sentences containing locative prepositions led to improvements not only in the comprehension of such sentences but also in the comprehension of reversible verb sentences. In the present study, 14 aphasic patients were selected for having problems with sentence-picture matching involving reversible verb and preposition sentences. These problems were shown to be stable across three pre-intervention assessments. All assessments were computer-based and involved the matching of written sentences to pictures. A small vocabulary was used in assessment and therapy which involved a \"microworld\" of three characters (ball, box, and star) which could engage in a limited number of actions and could occupy a limited set of spatial relationships. Before therapy began, all the patients were given an assessment battery which included a 40-item Verb Test and a 40-item Preposition Test. The patients were then divided into two groups, A and B. Group A received two 1-hr sessions of therapy per week for 3 weeks aimed at improving the comprehension of verb sentences, then a second full assessment, followed by the same amount of therapy aimed at improving the comprehension of preposition sentences, and finally a third assessment. Group B received the preposition therapy first, followed by the verb therapy. The therapy involved the patient and therapist interacting with the computer, either assembling pictures to match written sentences (\"picture-building mode\") or assembling sentences to match pictures (\"sentence-building mode\"). Group A showed a classical \"cross-over\" treatment outcome. Performance on treated verb sentences improved during verb therapy and was retained when therapy switched to preposition sentences. Performance on treated preposition sentences was unaffected by verb therapy but improved when therapy switched to the processing of prepositions. Performance on untreated verb and preposition sentences showed a similar pattern, though the improvements observed were not as great. Improvement was also shown on a paper-based \"Real World Test\" which involved a wider range of more naturalistic sentences. Performance on a third aspect of sentence comprehension which the patients also had difficulty with, namely the comprehension of morphology, remained unchanged throughout, providing further evidence that the effects obtained were treatment-specific. The results of Group B were less clear cut. Comprehension of both verb and preposition sentences improved during the period that prepositions were being treated then remained static during verb treatment. Comprehension of morphology remained unchanged throughout. At the level of the individual patient, the majority of patients obtained higher scores on both the Verb Test and the Preposition Test after therapy, but only three patients showed improvements on both verbs and prepositions that were statistically significant. Six patients showed significant improvements on verbs but not prepositions while one showed the opposite pattern. Only three patients failed to show so much as a borderline improvement on either verbs or prepositions. Finally, seven of the patients returned for an additional assessment 5 months after completing the therapy. These patients, who had demonstrated significant improvements during the therapy, were shown to have maintained their improved comprehension skills.", "This study examined the efficacy of a treatment, Oral Reading for Language in Aphasia (ORLA), delivered by computer to individuals with chronic nonfluent aphasia and compared its efficacy with the same treatment delivered by a speech-language pathologist (SLP).\n With ORLA, the person with aphasia systematically and repeatedly reads aloud sentences, first in unison and then independently. Following a no-treatment period, 25 individuals with chronic nonfluent aphasia were randomly assigned to receive 24 sessions of ORLA, 1-3 times per week, either by computer or by the SLP.\n For participants receiving computer ORLA, change made on the Western Aphasia Battery Aphasia Quotient (WAB-AQ) during the treatment phase was larger than the change made during the no-treatment phase. Positive effect sizes for change during treatment compared with change during the no-treatment phase were obtained and were benchmarked as medium or large for the WAB-AQ and discourse measures. There was no significant difference between outcomes for computer ORLA compared with SLP-ORLA.\n Low-intensity ORLA, delivered by computer to individuals with chronic nonfluent aphasia, is efficacious and may be equivalent to ORLA delivered by an SLP.", "We randomly assigned 33 patients with left hemisphere stroke, limb apraxia, and aphasia to an apraxia or a control (aphasia) treatment group. Before and after each treatment, patients underwent a comprehensive neuropsychological testing battery and a caregiver evaluation of patient's activities of daily life (ADL) independence. Apraxia severity was related with ADL independence. Control (aphasia) treatment improved patients' language and intelligence performance. Apraxia treatment specifically improved praxic function and ADL.", "Five Veterans Administration Medical Centers participated in an investigation designed to compare individual with group treatment for aphasic patients who had suffered a left hemisphere cerebral vascular accident. Patients who met selection criteria were assigned randomly to either traditional, individual, stimulus-response type treatment of specific language deficits or group therapy designed to improve communication through group interaction and discussion with no direct treatment of specific language deficits. All patients received eight hours of therapy each week beginning at four weeks postonset and continuing until 48 weeks postonset or until they dropped out of the study. A battery of language measures and a clinical neurologic evaluation were administered at intake and every 11 weeks a patient was in the study. Results show both individually and group-treated patients made significant improvement in language abilities. Individual treatment resulted in significantly better overall performance on the Porch Index of Communicative Ability; however, no significant differences were observed between groups on the other language measures. If the traditional belief is correct that significant spontaneous recovery is complete by three to six months postonset, significant improvement in both groups beyond 26 weeks postonset indicates both individual and group treatment are efficacious methods for managing aphasic patients.", "To evaluate the therapeutic effects of scalp acupuncture (with the cluster needling, a long needle-retention and an intermittent manipulation) combined with the Schuell's stimulation and psychological care for treatment of aphasia due to cerebrovascular disorders.\n 36 eligible cases of aphasia were randomly assigned into a treatment group and a control group. The scoring system for assessment of aphasia in speaking Chinese set by CMA Neurological Branch and that of BADE were adopted for grading the severity/degree of aphasia before and after the treatment.\n The total effective rate in the treatment group was 84.21%, and that in the control group was 70.59%, with a very statistically significant difference (P < 0.01).\n The combined scheme produced a better therapeutic effect.", "Most clinicians would recommend speech and language therapy (SLT) for aphasic patients. The question of when and for how long SLT should be administered still remains controversial. The aim of this trial is to evaluate the efficacy of early SLT in patients with acute stroke and aphasia in a randomized controlled trial. This report will present design and methods and discuss feasibility.\n Consecutive patients with first ever ischemic stroke and aphasia are assessed by the Amsterdam-Nijmegen Everyday Language Test (ANELT) and a short version of the Norsk Grunntest for Afasi. The treatment is language enrichment therapy, and the therapy is given 45 min/day for 15 weekdays. The primary outcome is the difference in the degree of aphasia between the SLT treated group and the control group measured by ANELT at 3 weeks.\n Around 10% of acute consecutive patients with aphasia are included. Of the first 79 included patients, 86% have completed the study according to protocol. We intend to include 125 patients, which provide sufficient statistical power to detect a clinically significant difference in the degree of aphasia.\n It is feasible to conduct a randomized controlled study on very early SLT for acute aphasic patients." ]

[ "1418021", "7008711", "2239170", "3548986", "4589408", "18802222" ]

[ "Effect of intraarticular glycosaminoglycan polysulfate treatment on patellofemoral pain syndrome. A prospective, randomized double-blind trial comparing glycosaminoglycan polysulfate with placebo and quadriceps muscle exercises.", "Effect of aspirin treatment on chondromalacia patellae.", "Effect of glycosaminoglycan polysulfate on chondromalacia patellae. A placebo-controlled 1-year study.", "Comparison of diflunisal and naproxen for relief of anterior knee pain.", "Treatment of the painful knee fulfilling diagnostic criteria for 'chondromalacia patellae'.", "Physical therapy treatment of knee extensor mechanism disorders: comparison of four treatment modalities*." ]

[ "To compare the effects of intraarticular (IA) injections of glycosaminoglycan polysulfate (GAGPS) plus basic conservative treatment with the effects of placebo injections plus conservative treatment and with the effects of conservative treatment alone in patients with chronic patellofemoral pain syndrome (PFPS).\n We treated 53 patients who presented with chronic PFPS in 1 knee, according to 1 of the 3 protocols, in a prospective, randomized, double-blind study. Basic conservative treatment consisted of a 6-week program of quadriceps muscle exercise, elimination of symptom-producing activities, and oral doses of nonsteroidal antiinflammatory drugs. Physiologic saline served as placebo for injection. During the 6-week treatment period, 5 injections were given 1 week apart. Along with measurements of quadriceps strength, standardized subjective, functional, and clinical assessments were performed at presentation, after 6 weeks of treatment, and after 6 months.\n Results at 6 months indicated that IA injections of GAGPS or saline did not result in significant improvement beyond the good results achieved by the basic conservative treatment alone. More than two-thirds of the patients in each group experienced complete recovery.\n Neither the GAGPS injections nor the physiologic saline injections are more effective than conservative therapy in the treatment of chronic PFPS. Restoration of normal quadriceps muscle function to the affected knee seems to be crucial in treating PFPS.", "Twenty-nine patients (21 females and 8 males) with chondromalacia patellae diagnosed by arthroscopy were randomly allocated to receive aspirin or placebo for 3 months. Clinical and arthroscopic examination after 3 months showed no significant change in symptoms, signs, or macroscopic appearances in either group. Surgical treatment was performed in 14 patients for deteriorating symptoms.", "The effect of glycosaminoglycan polysulfate (GAGPS) on damaged patellar cartilage and clinical symptoms of chondromalacia was studied on 31 patients in a placebo-controlled double-blind trial. The clinical diagnosis was confirmed by arthroscopy. The treatment consisted of 12 intramuscular injections of either GAGPS or placebo, and the patients were followed for 1 year. In 26 patients, rearthroscopy was performed at the 1-year follow-up. Comparison of the two arthroscopies showed improvement in 8/13 patients in the GAGPS group compared with 3/13 in the placebo group. The clinical parameters correlated well with the results of the arthroscopies. The results support the use of GAGPS for chondromalacia patellae.", "Two nonsteroidal anti-inflammatory drugs, diflunisal and naproxen, were compared for efficacy in relieving anterior knee pain of mild to moderate severity. Of 36 patients completing the study, 20 received diflunisal and 16 received naproxen. Eleven (55%) patients given diflunisal and ten (63%) given naproxen had significant relief of pain, but there were no statistically significant differences between the two treatments. Although adverse reactions were frequent in both groups, they were not severe and they abated upon discontinuation of medication.", "nan", "Fifty-three patients diagnosed as having one of several types of extensor mechanism disorders of the knee were randomly assigned to one of four treatment groups to assess the effects of one of four different modalities (ice, phonophoresis, iontophoresis, and ultrasound/ice contrast). Following four physical therapy treatments over a 10-day period, the group treated with the ultrasound/ice contrast demonstrated the greatest subjective improvement (47%). The pre- to post-treatment isometric strength resulted in a 28% improvement in knee extension strength and a 34% improvement in knee flexion strength. The authors emphasize that evaluation should include assessment of quadriceps tone and strength as well as careful palpation to determine the irritable structures. Ultrasound/ice is advocated as the most effective choice of the modalities tested for treatment of pain associated with extensor mechanism disorders. J Orthop Sports Phys Ther 1986;8(5):255-259." ]

[ "15922815", "15823764" ]

[ "Analgesic efficacy and tolerability of oxycodone 5 mg/ibuprofen 400 mg compared with those of oxycodone 5 mg/acetaminophen 325 mg and hydrocodone 7.5 mg/acetaminophen 500 mg in patients with moderate to severe postoperative pain: a randomized, double-blind, placebo-controlled, single-dose, parallel-group study in a dental pain model.", "Combination oxycodone 5 mg/ibuprofen 400 mg for the treatment of postoperative pain: a double-blind, placebo- and active-controlled parallel-group study." ]

[ "Combination therapy has been widely used for the clinical management of acute pain. By combining 2 drugs with different mechanisms of action, such therapy provides additive analgesic effects while reducing the risk for adverse effects.\n This study compared the efficacy and tolerability of oxycodone 5 mg/ibuprofen 400 mg with those of oxycodone 5 mg/acetaminophen 325 mg, hydrocodone 7.5 mg/acetaminophen 500 mg, and placebo in a dental pain model.\n This was a multicenter, randomized, double-blind, placebo- and active-controlled, parallel-group, single-dose study in patients experiencing moderate to severe pain after surgical removal of > or = 2 ipsilateral impacted third molars. Patients were randomly assigned to receive oxycodone 5 mg/ibuprofen 400 mg, oxycodone 5 mg/acetaminophen 325 mg, hydrocodone 7.5 mg/acetaminophen 500 mg, or placebo. The primary outcome measures were total pain relief through 6 hours after dosing (TOTPAR6), sum of pain intensity differences through 6 hours (SPID6), and adverse events. Secondary efficacy measures included SPID3 and TOTPAR3, peak pain relief, peak pain intensity difference, time to onset of pain relief, time to use of rescue medication, proportion of patients reporting pain half gone, and the patient's global evaluation.\n Two hundred forty-nine patients (43.5% male; 87.5% white; mean age, 19.1 years; mean body weight, 153.6 pounds) were randomized to treatment as follows: 62 to oxycodone 5 mg/ibuprofen 400 mg, 61 to oxycodone 5 mg/acetaminophen 325 mg, 63 to hydrocodone 7.5 mg/acetaminophen 500 mg, and 63 to placebo. Oxycodone 5 mg/ibuprofen 400 mg provided significantly greater analgesia compared with oxycodone 5 mg/acetaminophen 325 mg, hydrocodone 7.5 mg/acetaminophen 500 mg, and placebo (mean [SD] TOTPAR6, 14.98 [5.37], 9.53 [6.77], 8.36 [6.68], and 5.05 [6.49], respectively; P < 0.001, oxycodone 5 mg/ibuprofen 400 mg vs all other treatments). SPID6 values also differed significantly for oxycodone 5 mg/ibuprofen 400 mg compared with all other treatments (mean: 7.78 [4.11], 3.58 [4.64], 3.32 [4.73], and 0.69 [4.85]; P < 0.001). Oxycodone 5 mg/ibuprofen 400 mg was significantly more effective compared with the other treatments on all secondary end points (P < 0.001, all variables except peak PID vs oxycodone 5 mg/acetaminophen 325 mg [P = 0.006]), with the exception of the time to onset of analgesia. The lowest frequency of nausea and vomiting occurred in the groups that received oxycodone 5 mg/ibuprofen 400 mg (6.5% and 3.2%, respectively) and placebo (3.2% and 1.6%). Rates of nausea and vomiting were significantly lower with oxycodone 5 mg/ibuprofen 400 mg compared with oxycodone 5 mg/acetaminophen 325 mg (P = 0.011 and P = 0.009, respectively) but not with hydrocodone 7.5 mg/acetaminophen 500 mg.\n In this study in patients with moderate to severe pain after surgery to remove impacted third molars, oxycodone 5 mg/ibuprofen 400 mg provided significantly better analgesia throughout the 6-hour study compared with the other opioid/nonopioid combinations tested, and was associated with fewer adverse events.", "This study compared the efficacy and safety of a single dose of oxycodone 5 mg/ibuprofen 400 mg versus its individual components and placebo in a third-molar extraction model.\n In this multicenter, double-blind, double-dummy, parallel-group investigation, subjects with moderate to severe pain within 5 hours after extraction of > or =2 ipsilateral bony impacted third molars were randomized to single doses of oxycodone 5 mg/ibuprofen 400 mg, ibuprofen 400 mg, oxycodone 5 mg, or placebo. Primary efficacy variables were the sum of pain intensity difference over 6 hours (SP1D6) and total pain relief through 6 hours (TOTPAR6). The pharmacokinetics of oxycodone and ibuprofen, alone and in combination, were also determined in a subset of patients.\n A total of 498 subjects were randomized to treatment (187 to oxycodone 5 mg/ibuprofen 400 mg, 186 to ibuprofen 400 mg, 63 to oxycodone 5 mg, and 62 to placebo). Baseline demographics were generally similar among treatment groups, despite differences in sex (P = 0.041) and race (P = 0.023). Combination therapy was associated with greater analgesia than ibuprofen alone, oxycodone alone, or placebo (mean [SE] TOTPAR6: 13.3 [0.52], 12.2 [0.52], 4.3 [0.82], and 4.2 [0.83], respectively [P < 0.001 vs oxycodone or placebo, P = 0.012 vs ibuprofen]; mean [SE] SP1D6: 6.54 [0.42], 5.41 [0.44], 0.14 [0.60], and 0.32 [0.59], respectively [P < 0.001 vs oxycodone or placebo, P = 0.002 vs ibuprofen]). Combination therapy was well tolerated. Pharmacokinetic results implied no interaction between oxycodone and ibuprofen.\n In this study, a single dose of oxycodone 5 mg/ibuprofen 400 mg was fast-acting, effective, and well tolerated in subjects with moderate to severe pain after dental surgery. Oxycodone 5 mg alone did not provide an efficacy benefit over placebo in this study." ]

[ "15943939", "10396791", "16445556" ]

[ "Buprenorphine versus methadone in the treatment of pregnant opioid-dependent patients: effects on the neonatal abstinence syndrome.", "Comparison of methadone and slow-release morphine maintenance in pregnant addicts.", "Methadone versus buprenorphine in pregnant addicts: a double-blind, double-dummy comparison study." ]

[ "This study was designed to compare the neonatal abstinence syndrome (NAS) in neonates of methadone and buprenorphine maintained pregnant opioid-dependent women and to provide preliminary safety and efficacy data for a larger multi-center trial. This randomized, double-blind, double-dummy, flexible dosing, parallel-group controlled trial was conducted in a comprehensive drug-treatment facility that included residential and ambulatory care. Participants were opioid-dependent pregnant women and their neonates. Treatment involved daily administration of either sublingual buprenorphine or oral methadone using flexible dosing of 4-24 mg or 20-100 mg, respectively. Primary a priori outcome measures were: (1) number of neonates treated for NAS; (2) amount of opioid agonist medication used to treat NAS; (3) length of neonatal hospitalization; and (4) peak NAS score. Two of 10 (20%) buprenorphine-exposed and 5 of 11 (45.5%) methadone-exposed neonates were treated for NAS (p=.23). Total amount of opioid-agonist medication administered to treat NAS in methadone-exposed neonates was three times greater than for buprenorphine-exposed neonates (93.1 versus 23.6; p=.13). Length of hospitalization was shorter for buprenorphine-exposed than for methadone-exposed neonates (p=.021). Peak NAS total scores did not significantly differ between groups (p=.25). Results suggest that buprenorphine is not inferior to methadone on outcome measures assessing NAS and maternal and neonatal safety when administered starting in the second trimester of pregnancy.", "To investigate whether the neonatal abstinence syndrome (NAS) is different in children born to women maintained on slow-release morphine, compared with those maintained on methadone, and to compare additional drug consumption in these groups of women.\n An open, randomized trial was conducted in an established clinic. Forty-eight pregnant women who presented to the clinic as opiate or polysubstance abusers were enrolled and maintained on either methadone (24 women) or slow-release morphine (24 women) up to and following delivery. The programme included psychosocial therapy and support for their opiate-addicted partners.\n Standard urinalysis methods were used to measure consumption of cocaine and benzodiazepines during pregnancy. Injection sites were monitored to indicate additional opiate use. NAS was measured according to Finnegan score and the amount of phenobarbiturates prescribed to alleviate the symptoms.\n No difference was found in the number of days that NAS was experienced by neonates born to methadone or morphine maintained mothers (mean = 16 and 21 days, respectively). All children were born healthy and no serious complications arose. Fewer benzodiazepines (p < 0.05) and fewer additional opiates (p < 0.05) were consumed by the morphine-maintained women compared with those who took methadone, but no difference was seen in cocaine consumption. Nicotine consumption was reduced significantly in both groups during pregnancy (p < 0.02).\n Both methadone and morphine are suitable maintenance agents for pregnant opiate addicts. Maintenance agents that result in a less prolonged NAS should be studied in further trials.", "To evaluate the efficacy and safety of methadone versus buprenorphine treatment in pregnant opioid-dependent women.\n Randomized, double-dummy, double-blind, flexible-dosing comparison study.\n Addiction Clinic at the Medical University of Vienna, Austria.\n Eighteen women were assigned randomly to receive either methadone (n = 9) or buprenorphine (n = 9) during weeks 24-29 of pregnancy. After dropouts, data were available from 14 cases (six in the methadone and eight in the buprenorphine group).\n Sublingual buprenorphine tablets (8-24 mg/day) or oral methadone solution (40-100 mg/day), with matched placebos.\n Mothers: retention in treatment, urine toxicology and nicotine use. Neonates: Routine birth data, neonatal abstinence syndrome (NAS) in severity and duration.\n There was somewhat greater retention in the buprenorphine group but significantly lowered use of additional opioids in the methadone group (P = 0.047).Neonates: There was earlier onset of NAS in neonates born to the methadone (mean 60 hours) than to the buprenorphine groups (mean 72 hours after last medication); 43% did not require NAS-treatment with short treatment duration in both groups (mean 5 days).\n This preliminary study had limited power to detect differences but the trends observed suggest this kind of research is practicable and that further studies are warranted." ]

[ "10485720", "16816557", "16425125", "12478070", "10459958", "16284530", "10459959", "16411341", "17143826", "21237718", "16052084", "7935654", "18520682", "15247338", "11018164", "11955535", "16103773", "10459957", "18839781", "20554983", "12599045", "11529355" ]

[ "Intrapartum and neonatal single-dose nevirapine compared with zidovudine for prevention of mother-to-child transmission of HIV-1 in Kampala, Uganda: HIVNET 012 randomised trial.", "Maternal single-dose nevirapine versus placebo as part of an antiretroviral strategy to prevent mother-to-child HIV transmission in Botswana.", "Development of nevirapine resistance in infants is reduced by use of infant-only single-dose nevirapine plus zidovudine postexposure prophylaxis for the prevention of mother-to-child transmission of HIV-1.", "Compliance with antiretroviral regimens to prevent perinatal HIV-1 transmission in Kenya.", "Short-course oral zidovudine for prevention of mother-to-child transmission of HIV-1 in Abidjan, Côte d'Ivoire: a randomised trial.", "Effectiveness of short-term and long-term zidovudine prophylaxis on detection of HIV-1 subtype E in human placenta and vertical transmission.", "6-month efficacy, tolerance, and acceptability of a short regimen of oral zidovudine to reduce vertical transmission of HIV in breastfed children in Côte d'Ivoire and Burkina Faso: a double-blind placebo-controlled multicentre trial. DITRAME Study Group. DIminution de la Transmission Mère-Enfant.", "A randomized control trial of an Ultra-Short zidovudine regimen in the prevention of perinatal HIV transmission in rural Zimbabwe.", "A randomized, double-blind, placebo-controlled trial of combined nevirapine and zidovudine compared with nevirapine alone in the prevention of perinatal transmission of HIV in Zimbabwe.", "Triple antiretroviral compared with zidovudine and single-dose nevirapine prophylaxis during pregnancy and breastfeeding for prevention of mother-to-child transmission of HIV-1 (Kesho Bora study): a randomised controlled trial.", "A randomized trial of two postexposure prophylaxis regimens to reduce mother-to-child HIV-1 transmission in infants of untreated mothers.", "Reduction of maternal-infant transmission of human immunodeficiency virus type 1 with zidovudine treatment. Pediatric AIDS Clinical Trials Group Protocol 076 Study Group.", "Addition of single-dose tenofovir and emtricitabine to intrapartum nevirapine to reduce perinatal HIV transmission.", "Single-dose perinatal nevirapine plus standard zidovudine to prevent mother-to-child transmission of HIV-1 in Thailand.", "A trial of shortened zidovudine regimens to prevent mother-to-child transmission of human immunodeficiency virus type 1. Perinatal HIV Prevention Trial (Thailand) Investigators.", "Efficacy of three short-course regimens of zidovudine and lamivudine in preventing early and late transmission of HIV-1 from mother to child in Tanzania, South Africa, and Uganda (Petra study): a randomised, double-blind, placebo-controlled trial.", "Breast milk HIV-1 suppression and decreased transmission: a randomized trial comparing HIVNET 012 nevirapine versus short-course zidovudine.", "Short-course zidovudine for perinatal HIV-1 transmission in Bangkok, Thailand: a randomised controlled trial. Bangkok Collaborative Perinatal HIV Transmission Study Group.", "Highly active antiretroviral therapy versus zidovudine/nevirapine effects on early breast milk HIV type-1 Rna: a phase II randomized clinical trial.", "Antiretroviral regimens in pregnancy and breast-feeding in Botswana.", "A multicenter randomized controlled trial of nevirapine versus a combination of zidovudine and lamivudine to reduce intrapartum and early postpartum mother-to-child transmission of human immunodeficiency virus type 1.", "Short course zidovudine maternal treatment in HIV-1 vertical transmission: randomized controlled multicenter trial." ]

[ "The AIDS Clinical Trials Group protocol 076 zidovudine prophylaxis regimen for HIV-1-infected pregnant women and their babies has been associated with a significant decrease in vertical HIV-1 transmission in non-breastfeeding women in developed countries. We compared the safety and efficacy of short-course nevirapine or zidovudine during labour and the first week of life.\n From November, 1997, to April, 1999, we enrolled 626 HIV-1-infected pregnant women at Mulago Hospital in Kampala, Uganda. We randomly assigned mothers nevirapine 200 mg orally at onset of labour and 2 mg/kg to babies within 72 h of birth, or zidovudine 600 mg orally to the mother at onset of labour and 300 mg every 3 h until delivery, and 4 mg/kg orally twice daily to babies for 7 days after birth. We tested babies for HIV-1 infection at birth, 6-8 weeks, and 14-16 weeks by HIV-1 RNA PCR. We assessed HIV-1 transmission and HIV-1-free survival with Kaplan-Meier analysis.\n Nearly all babies (98.8%) were breastfed, and 95.6% were still breastfeeding at age 14-16 weeks. The estimated risks of HIV-1 transmission in the zidovudine and nevirapine groups were: 10.4% and 8.2% at birth (p=0.354); 21.3% and 11.9% by age 6-8 weeks (p=0.0027); and 25.1% and 13.1% by age 14-16 weeks (p=0.0006). The efficacy of nevirapine compared with zidovudine was 47% (95% CI 20-64) up to age 14-16 weeks. The two regimens were well tolerated and adverse events were similar in the two groups.\n Nevirapine lowered the risk of HIV-1 transmission during the first 14-16 weeks of life by nearly 50% in a breastfeeding population. This simple and inexpensive regimen could decrease mother-to-child HIV-1 transmission in less-developed countries.", "Single-dose nevirapine given to women and infants reduces mother-to-child HIV transmission, but nevirapine resistance develops in a large percentage of women.\n To determine whether the maternal nevirapine dose could be eliminated in the setting of zidovudine prophylaxis.\n A 2 x 2 factorial, randomized, clinical trial, with a double-blinded peripartum factor designed to assess the equivalence of maternal single-dose nevirapine versus placebo with respect to HIV transmission. A total of 709 HIV-infected pregnant women were randomized from four district hospitals in Botswana, resulting in 694 live first-born infants. HAART was available for women with AIDS.\n All women received a background of zidovudine from 34 weeks' gestation through delivery, and all infants received single-dose nevirapine at birth and zidovudine from birth through 1 month. Women were randomized to receive either single-dose nevirapine or placebo during labor.\n The primary endpoint was infant HIV infection by the 1-month visit.\n Of the 694 infants in this equivalence study, 15 (4.3%) of 345 in the maternal nevirapine arm were HIV infected by 1 month, versus 13 (3.7%) of 349 in the maternal placebo arm (95% confidence interval for difference, -2.4% to 3.8%), meeting pre-determined equivalence criteria. Nevirapine resistance at 1 month postpartum was detected in 45% of a random sample of women who received nevirapine.\n In the setting of maternal zidovudine and infant zidovudine plus single-dose nevirapine, infant HIV infection rates were similar whether women received single-dose nevirapine or placebo. This strategy avoids the potential for maternal nevirapine resistance.", "We analyzed the development of nevirapine (NVP) resistance in human immunodeficiency virus type 1 (HIV-1)-infected Malawian infants who received regimens containing single-dose NVP (SD-NVP) for the prevention of mother-to-child transmission (MTCT) of HIV-1. All infants received SD-NVP, and some randomly received zidovudine (ZDV) as well. Mothers did or did not receive SD-NVP on the basis of when they arrived at the hospital for delivery. In infants 6-8 weeks of age, NVP resistance was less frequent when infants had received SD-NVP plus ZDV and mothers had not received SD-NVP than when infants had received SD-NVP alone and mothers had received SD-NVP (4/15 [27%] vs. 20/23 [87%]; P < .001). The risk of MTCT of HIV-1 was comparable with these regimens. Infant-only prophylaxis also eliminates the development of NVP resistance in mothers.", "To compare compliance and infant HIV-1 infection risk at 6 weeks with the Thai-CDC and HIVNET-012 antiretroviral regimens in a field setting.\n Randomized clinical trial.\n Tertiary hospital antenatal clinic in Nairobi, Kenya.\n HIV-1 infected women referred from primary care clinics.\n Thai-CDC zidovudine regimen or HIVNET-012 nevirapine regimen.\n Women were considered compliant if they used >or= 80% of the doses. Infants were tested for HIV-1 at 6 weeks. RESULTS Seventy women were randomized to Thai-CDC and 69 to HIVNET-012 regimens. More women were compliant with the antenatal (86%) than the intrapartum (44%) Thai-CDC regimen doses ( P= 0.001). Ninety-seven per cent took the maternal and 91% gave the infant dose of the HIVNET-012 regimen (P = 0.2). Overall, 41% were compliant with the Thai-CDC regimen and 87% with the HIVNET-012 regimen ( P< 0.001). Compliance with the Thai-CDC regimen was associated with partner support of antiretroviral use [odds ratio (OR), 3.0;, 95% confidence interval (CI), 1.0-9.1] and knowledge at recruitment that antiretroviral drugs could prevent infant HIV-1 (OR, 2.9; 95% CI, 1.0-8.1). Compliance with the HIVNET-012 regimen was associated with partner notification (OR, 8.0; 95% CI, 1.5-50) and partner willingness to have HIV-1 testing (OR, 7.5; 95% CI, 1.4-40). There was a trend for a higher risk of transmission with the HIVNET-012 regimen than with the Thai-CDC regimen (22% versus 9%; P= 0.07).\n Compliance with the Thai-CDC and HIVNET-012 regimens was comparable to that in efficacy trials. Partner involvement, support and education on perinatal HIV-1 prevention may improve compliance and increase the number of infants protected from HIV-1 infection.", "In Africa, the risk of mother-to-child transmission of HIV-1 infection is high. Short-course perinatal oral zidovudine might decrease the rate of transmission. We assessed the safety and efficacy of such a regimen among HIV-1-seropositive breastfeeding women in Abidjan, Côte d'Ivoire.\n From April, 1996, to February, 1998, all consenting, eligible HIV-1-seropositive pregnant women attending a public antenatal clinic in Abidjan were enrolled at 36 weeks' gestation and randomly assigned placebo or zidovudine (300 mg tablets), one tablet twice daily until the onset of labour, one tablet at onset of labour, and one tablet every 3 h until delivery. We used HIV-1-DNA PCR to test the infection status of babies at birth, 4 weeks, and 3 months. We stopped the study on Feb 18, 1998, when efficacy results were available from a study in Bangkok, Thailand, in which the same regimen was used in a non-breastfeeding population.\n 280 women were enrolled (140 in each group). The median duration of the prenatal drug regimen was 27 days (range 1-80) and the median duration of labour was 7.5 h. Treatment was well tolerated with no withdrawals because of adverse events. All babies were breastfed. Among babies with known infection status at age 3 months, 30 (26.1%) of 115 babies in the placebo group and 19 (16.5%) of 115 in the zidovudine group were identified as HIV-1 infected. The estimated risk of HIV-1 transmission in the placebo and zidovudine groups were 21.7% and 12.2% (p=0.05) at 4 weeks, and 24.9% and 15.7% (p=0.07) at 3 months. Efficacy was 44% (95% CI -1 to 69) at age 4 weeks and 37% (-5 to 63) at 3 months.\n Short-course oral zidovudine was safe, well tolerated, and decreased mother-to-child transmission of HIV-1 at age 3 months. Substantial efforts will be needed to ensure successful widespread implementation of such a regimen.", "Antiretroviral treatment with zidovudine (ZDV) from the 14th week until the end of pregnancy has markedly reduced the vertical transmission rate of HIV-1 in Europe and North America. A shorter duration of treatment has reduced this rate in Africa and Southeast Asia to a lesser degree. In Southeast Asia, subtype E is the major subtype rather than subtype B as in Western countries. The goals of this study were to determine the optimal duration of ZDV prophylaxis for subtype E and to confirm its effectiveness at the histologic level. Fifty pregnant women seropositive for HIV-1 subtype E were given ZDV prophylaxis consisting of 300 mg administered twice daily, switching to 300 mg administered every 3 hours from the onset of labor until delivery. Twenty-seven received \"short-term\" ZDV lasting 14 to 35 days before delivery, whereas the other 23 received \"long-term\" ZDV lasting 62 to 92 days. The effectiveness of ZDV prophylaxis was assessed by detection of HIV-1 in the placenta using in situ polymerase chain reaction (PCR). All babies in this study were tested up to one year of age. Three were not positive until after one month of age, but one was positive as a neonate. Four neonates were positive for HIV-1 as detected by PCR on peripheral blood, including one in the neonatal period. All cases were from the short-term prophylaxis group. Decidual glandular epithelial cells were the only cell type in the placenta that expressed HIV proviral DNA under ZDV prophylaxis. Sixty-seven percent of placentas in the short-term ZDV group showed more than occasional positive cells compared with 22% in the group receiving long-term ZDV prophylaxis (P < 0.02). This is first study to compare the effectiveness of short-term and long-term ZDV prophylaxis with respect to the presence of HIV in the placenta. Our study shows that longer (at least 60 days) prophylaxis is more effective in reducing HIV expression in the placenta and is associated with reduced transmission to neonates.", "Zidovudine reduces the rate of vertical transmission of HIV in non-breastfed populations. We assessed the acceptability, tolerance, and 6-month efficacy of a short regimen of oral zidovudine in African populations practising breastfeeding.\n A randomised double-blind placebo-controlled trial was carried out in public clinics of Abidjan, Côte d'Ivoire, and Bobo-Dioulasso, Burkina Faso. Eligible participants were women aged 18 years or older, who had confirmed HIV-1 infection and pregnancy of 36-38 weeks duration, and who gave written informed consent. Exclusion criteria were severe anaemia, neutropenia, abnormal liver function, and sickle-cell disease. Women were randomly assigned zidovudine (n=214; 300 mg twice daily until labour, 600 mg at beginning of labour, and 300 mg twice daily for 7 days post partum) or matching placebo (n=217). The primary outcome was the diagnosis of HIV-1 infection in the infant on the basis of sequential DNA PCR tests at days 1-8, 45, 90, and 180. We compared the probability of infection at a given age in the two groups. Analyses were by intention to treat.\n Women were enrolled between September, 1995, and February, 1998, when enrolment to the placebo group was stopped. Analysis was based on 421 women and 400 lifeborn infants. Baseline demographic, clinical, and laboratory characteristics were similar in the two groups. The Kaplan-Meier probability of HIV infection in the infant at 6 months was 18.0% in the zidovudine group (n=192) and 27.5% in the placebo group (n=197; relative efficacy 0.38 [95% CI 0.05-0.60]; p=0.027). Adjustment for centre, period of recruitment, mode of delivery, maternal CD4-cell count, duration of labour, prolonged rupture of membranes, and duration of breastfeeding did not change the treatment effect. The proportions of women taking more than 80% of the planned maximum dose were 75% before delivery, 81% during labour, and 83% post partum, without statistical difference between the groups. No major adverse biological or clinical event was reported in excess among women and children of the zidovudine group.\n A short course of oral zidovudine given during the peripartum period is well accepted and well tolerated, and provides a 38% reduction in early vertical transmission of HIV-1 infection despite breastfeeding.", "To assess the practicality and effectiveness of an Ultra-Short zidovudine regimen for prevention of perinatal HIV transmission in rural Zimbabwe.\n Double-blinded placebo-controlled randomized clinical trial.\n The Salvation Army Howard Hospital, a district hospital in rural Zimbabwe.\n 222 HIV positive pregnant women presenting for antenatal care prior to 36 weeks were randomized. Twenty nine women were lost to follow up.\n In the Thai regimen, mothers received zidovudine (300 mg po bid) from 36 weeks gestation until labour, and zidovudine (300 mg po q3h) during labour, and the neonates received a placebo. In the Ultra-Short regimen, the mothers received a placebo from 36 weeks to labour, then zidovudine (300 mg po q3h) in labour. The neonates received zidovudine (2 mg/kg po qid) for the first three days of life.\n Infant HIV RNA status at six weeks of life.\n Results were available for 90 infants from the Thai group and 89 infants from the Ultra-Short group. Infant HIV seroconversion rates at six weeks of life were 18.9% (95%CI 10.8 to 27.0) with the Thai regimen, and 15.7% [95% Confidence Interval (CI) 8.1 to 23.4] with the Ultra-Short regimen. The upper bound of seroconversion in the Ultra-Short group was lower than the 25% seroconversion boundary that was specified to show equivalence.\n Although the Ultra-Short regimen has equivalent efficacy to the Thai regimen, it also has many practical advantages. Ultra-Short is thus a preferable protocol.", "A single dose of nevirapine (sdNVP) administered to both mother and infant can decrease mother-to-child transmission of human immunodeficiency virus (HIV) by 47%, compared with ultra-short course zidovudine therapy (usZDV). There is limited data about the benefit of usZDV added to sdNVP to prevent mother-to-child transmission.\n We performed a double-blind, randomized, placebo-controlled trial to determine whether usZDV combined with sdNVP improved neonatal outcome, compared with sdNVP alone. Mothers were randomized to 1 of 2 treatment groups. Mothers in the usZDV/sdNVP group received a loading dose of zidovudine (600 mg administered orally) and continued to receive 300-mg doses of zidovudine orally every 3 h while in labor, and their infants received zidovudine at a dosage of 2 mg per kg of body weight 4 times per day orally for 72 h. Mothers and infants in the sdNVP group received zidovudine placebo dosed in the same manner. All mothers also received nevirapine at a dosage of 200 mg orally while in labor, and all infants received nevirapine 2 mg per kg of body weight orally within 72 h of delivery.\n The study was stopped on the basis of futility, because interim data showed that, at present trends, superiority would not be demonstrated. Results at 6 weeks of age were available for 609 infants. The primary end point of HIV RNA positivity or death occurred in 21.8% of infants in the usZDV/sdNVP arm and 23.6% of the infants in the sdNVP arm.\n usZDV, when added to a standard 2-dose regimen of sdNVP, did not demonstrate a clinically important decrease in the combined end point of mother-to-child transmission or infant death. High rates of adverse maternal and infant outcome in both study arms suggest that improved approaches are necessary.", "Breastfeeding is essential for child health and development in low-resource settings but carries a significant risk of transmission of HIV-1, especially in late stages of maternal disease. We aimed to assess the efficacy and safety of triple antiretroviral compared with zidovudine and single-dose nevirapine prophylaxis in pregnant women infected with HIV.\n Pregnant women with WHO stage 1, 2, or 3 HIV-1 infection who had CD4 cell counts of 200-500 cells per μL were enrolled at five study sites in Burkina Faso, Kenya, and South Africa to start study treatment at 28-36 weeks' gestation. Women were randomly assigned (1:1) by a computer generated random sequence to either triple antiretroviral prophylaxis (a combination of 300 mg zidovudine, 150 mg lamivudine, and 400 mg lopinavir plus 100 mg ritonavir twice daily until cessation of breastfeeding to a maximum of 6·5 months post partum) or zidovudine and single-dose nevirapine (300 mg zidovudine twice daily until delivery and a dose of 600 mg zidovudine plus 200 mg nevirapine at the onset of labour and, after a protocol amendment in December, 2006, 1 week post-partum zidovudine 300 mg twice daily and lamivudine 150 mg twice daily). All infants received a 0·6 mL dose of nevirapine at birth and, from December, 2006, 4 mg/kg twice daily of zidovudine for 1 week after birth. Patients and investigators were not masked to treatment. The primary endpoints were HIV-free infant survival at 6 weeks and 12 months; HIV-free survival at 12 months in infants who were ever breastfed; AIDS-free survival in mothers at 18 months; and serious adverse events in mothers and babies. Analysis was by intention to treat. This trial is registered with Current Controlled Trials, ISRCTN71468401.\n From June, 2005, to August, 2008, 882 women were enrolled, 824 of whom were randomised and gave birth to 805 singleton or first, liveborn infants. The cumulative rate of HIV transmission at 6 weeks was 3·3% (95% CI 1·9-5·6%) in the triple antiretroviral group compared with 5·0% (3·3-7·7%) in the zidovudine and single-dose nevirapine group, and at 12 months was 5·4% (3·6-8·1%) in the triple antiretroviral group compared with 9·5% (7·0-12·9%) in the zidovudine and single-dose nevirapine group (p=0·029). The cumulative rate of HIV transmission or death at 12 months was 10·2% (95% CI 7·6-13·6%) in the triple antiretroviral group compared with 16·0% (12·7-20·0%) in the zidovudine and single-dose nevirapine group (p=0·017). In infants whose mothers declared they intended to breastfeed, the cumulative rate of HIV transmission at 12 months was 5·6% (95% CI 3·4-8·9%) in the triple antiretroviral group compared with 10·7% (7·6-14·8%) in the zidovudine and single-dose nevirapine group (p=0·02). AIDS-free survival in mothers at 18 months will be reported in a different publication. The incidence of laboratory and clinical serious adverse events in both mothers and their babies was similar between groups.\n Triple antiretroviral prophylaxis during pregnancy and breastfeeding is safe and reduces the risk of HIV transmission to infants. Revised WHO guidelines now recommend antiretroviral prophylaxis (either to the mother or to the baby) during breastfeeding if the mother is not already receiving antiretroviral treatment for her own health.\n Agence nationale de recherches sur le sida et les hépatites virales, Department for International Development, European and Developing Countries Clinical Trials Partnership, Thrasher Research Fund, Belgian Directorate General for International Cooperation, Centers for Disease Control and Prevention, Eunice Kennedy Shriver National Institute of Child Health and Human Development, and UNDP/UNFPA/World Bank/WHO Special Programme of Research, Development and Research Training in Human Reproduction.\n Copyright © 2011 Elsevier Ltd. All rights reserved.", "Single-dose nevirapine (NVP) prophylaxis to mother and infant is widely used in resource-constrained settings for preventing mother-to-child transmission (MTCT) of HIV-1. Where women do not access antenatal care or HIV testing, postexposure prophylaxis to the infant may be an important preventative strategy.\n This multicentre, randomized, open-label clinical trial (October 2000 to September 2002) in South Africa compared single-dose NVP with 6 weeks of zidovudine (ZDV), commenced within 24 h of delivery among 1051 infants whose mothers had no prior antiretroviral therapy. HIV-1 infection rates were ascertained at birth, and at 6 and 12 weeks of age. Kaplan-Meier survival methods were used to estimate HIV-1 infection rates in an intention-to-treat analysis.\n Overall, 6 week and 12 week MTCT probability was 12.8% [95% confidence interval (CI),10.5-15.0] and 16.3% (95% CI,13.4-19.2), respectively. At 12 weeks, among infants who were not infected at birth, 24 (7.9%) infections occurred in the NVP arm and 41 (13.1%) in the ZDV arm (log rank P = 0.06). Using multivariate analysis, factors associated with infection following birth were ZDV use [odds ratio (OR), 1.8; 95% CI,1.1-3.2; P = 0.032), maternal CD4 cell count < 500 x 10(6) cells/l (OR, 2.5; 95% CI,1.3-5.0; P = 0.007), maternal viral load > 50 000 copies/ml (OR, 3.6; 95% CI,2.0-6.2; P < 0.0001) and breastfeeding (OR, 2.2; 95% CI,1.3-3.8; P = 0.006).\n A single-dose of NVP given to infants offers protection against HIV-1 infection and should be a strategy used in infants of mothers with untreated HIV infection.", "Maternal-infant transmission is the primary means by which young children become infected with human immunodeficiency virus type 1 (HIV). We conducted a randomized, double-blind, placebo-controlled trial of the efficacy and safety of zidovudine in reducing the risk of maternal-infant HIV transmission. HIV-infected pregnant women (14 to 34 weeks' gestation) with CD4+ T-lymphocyte counts above 200 cells per cubic millimeter who had not received antiretroviral therapy during the current pregnancy were enrolled. The zidovudine regimen included antepartum zidovudine (100 mg orally five times daily), intrapartum zidovudine (2 mg per kilogram of body weight given intravenously over one hour, then 1 mg per kilogram per hour until delivery), and zidovudine for the newborn (2 mg per kilogram orally every six hours for six weeks). Infants with at least one positive HIV culture of peripheral-blood mononuclear cells were classified as HIV-infected.\n From April 1991 through December 20, 1993, the cutoff date for the first interim analysis of efficacy, 477 pregnant women were enrolled; during the study period, 409 gave birth to 415 live-born infants. HIV-infection status was known for 363 births (180 in the zidovudine group and 183 in the placebo group). Thirteen infants in the zidovudine group and 40 in the placebo group were HIV-infected. The proportions infected at 18 months, as estimated by the Kaplan-Meier method, were 8.3 percent (95 percent confidence interval, 3.9 to 12.8 percent) in the zidovudine group and 25.5 percent (95 percent confidence interval, 18.4 to 32.5 percent) in the placebo group. This corresponds to a 67.5 percent (95 percent confidence interval, 40.7 to 82.1 percent) relative reduction in the risk of HIV transmission (Z = 4.03, P = 0.00006). Minimal short-term toxic effects were observed. The level of hemoglobin at birth in the infants in the zidovudine group was significantly lower than that in the infants in the placebo group. By 12 weeks of age, hemoglobin values in the two groups were similar.\n In pregnant women with mildly symptomatic HIV disease and no prior treatment with antiretroviral drugs during the pregnancy, a regimen consisting of zidovudine given ante partum and intra partum to the mother and to the newborn for six weeks reduced the risk of maternal-infant HIV transmission by approximately two thirds.", "To determine the impact of adjuvant single-dose peripartum tenofovir/emtricitabine (TDF/FTC) on intrapartum/early postpartum HIV transmission.\n In the setting of routine short-course zidovudine (ZDV) and peripartum nevirapine (NVP) for perinatal HIV prevention, participants were randomized to single-dose TDF (300 mg)/FTC (200 mg) or to no intervention in labor. Six-week infant HIV infection was compared according to actual-use drug regimens.\n Of 397 women randomized, 355 (89%) had infants who were alive and active at 6 weeks postpartum. Of these, 18 (5.1%) were infected in utero and 6 (1.8%) were infected intrapartum/early postpartum. Among the 243 who used ZDV and NVP, intrapartum/early postpartum transmission was not reduced among infants whose mothers received TDF/FTC compared with those who did not (2 of 123 [1.6%] vs. 3 of 109 [2.8%]; P = 0.67). Among the 49 infants whose mothers did not receive antenatal ZDV but who had confirmed NVP ingestion, transmission similarly did not differ (0 of 19 [0%] vs. 1 of 26 [3.4%]). TDF/FTC was not significantly associated with reduced overall transmission (odds ratio [OR] = 0.7, 95% confidence interval [CI]: 0.3 to 1.6), even when other antiretroviral drugs were considered (adjusted OR = 0.8, 95% CI: 0.3 to 1.8).\n Adjuvant peripartum single-dose TDF/FTC did not reduce perinatal transmission. Whether a higher dose might be effective remains unknown but should be studied in settings in which NVP is used without antenatal ZDV.", "Although zidovudine prophylaxis decreases the rate of transmission of the human immunodeficiency virus (HIV) type 1 substantially, a large number of infants still become infected. We hypothesized that the administration, in addition to zidovudine, of a single dose of oral nevirapine to mothers during labor and to neonates would further reduce transmission of HIV.\n We conducted a randomized, double-blind trial of three treatment regimens in Thai women who were receiving zidovudine therapy during the third trimester of pregnancy. In one group, mothers and infants received a single dose of nevirapine (nevirapine-nevirapine regimen); in another, mothers and infants received nevirapine and placebo, respectively (nevirapine-placebo regimen); and in the last, mothers and infants received placebo (placebo-placebo regimen). The infants also received one week of zidovudine therapy and were formula-fed. The end point of the study was infection with HIV in the infants, established by virologic testing.\n Between January 15, 2001, and February 28, 2003, a total of 1844 Thai women were enrolled. At the first interim analysis, the independent data monitoring committee stopped enrollment in the placebo-placebo group. Among women who delivered before the interim analysis, the as-randomized Kaplan-Meier estimates of the transmission rates were 1.1 percent (95 percent confidence interval, 0.3 to 2.2) in the nevirapine-nevirapine group and 6.3 percent (95 percent confidence interval, 3.8 to 8.9) in the placebo-placebo group (P<0.001). The final per-protocol transmission rate in the nevirapine-nevirapine group, 1.9 percent (95 percent confidence interval, 0.9 to 3.0), was not significantly inferior to the rate in the nevirapine-placebo group (2.8 percent; 95 percent confidence interval, 1.5 to 4.1). Nevirapine had an effect within subgroups defined by known risk factors such as viral load and CD4 count. No serious adverse effects were associated with nevirapine therapy.\n A single dose of nevirapine to the mother, with or without a dose of nevirapine to the infant, added to oral zidovudine prophylaxis starting at 28 weeks' gestation, is highly effective in reducing mother-to-child transmission of HIV.\n Copyright 2004 Massachusetts Medical Society", "The optimal duration of zidovudine administration to prevent perinatal transmission of human immunodeficiency virus type 1 (HIV-1) should be determined to facilitate its use in areas where resources are limited.\n We conducted a randomized, double-blind equivalence trial of zidovudine starting in the mother at 28 weeks' gestation, with 6 weeks of treatment in the infant (the long-long regimen), which is similar to protocol 076; zidovudine starting at 35 weeks' gestation, with 3 days of treatment in the infant (the short-short regimen); a long-short regimen; and a short-long regimen. The mothers received zidovudine orally during labor. The infants were fed formula and were tested for HIV DNA at 1, 45, 120, and 180 days. After the first interim analysis, the short-short regimen was stopped.\n A total of 1437 women were enrolled. At the first interim analysis, the rates of HIV transmission were 4.1 percent for the long-long regimen and 10.5 percent for the short-short regimen (P=0.004). For the entire study period, the transmission rates were 6.5 percent (95 percent confidence interval, 4.1 to 8.9 percent) for the long-long regimen, 4.7 percent (95 percent confidence interval, 2.4 to 7.0 percent) for the long-short regimen, and 8.6 percent (95 percent confidence interval, 5.6 to 11.6 percent) for the short-long regimen. The rate of in utero transmission was significantly higher with the two regimens with shorter maternal treatment (5.1 percent) than with the two with longer maternal treatment (1.6 percent).\n The short-short zidovudine regimen is inferior to the long-long regimen and leads to a higher rate of perinatal HIV transmission. The long-short, short-long, and long-long regimens had equivalent efficacy. However, the higher rate of in utero transmission with the short-long regimen suggests that longer treatment of the infant cannot substitute for longer treatment of the mother.", "Large reductions in transmission of HIV-1 from mother to child have been achieved in more-developed countries due to the use of antiretrovirals. Short-course regimens, suitable for resource-poor countries, have also been shown to significantly reduce peripartum HIV-1 transmission. We assessed the efficacy of short-course regimens with zidovudine and lamivudine in a predominantly breastfeeding population.\n We did a randomised, double-blind, placebo-controlled trial in South Africa, Uganda, and Tanzania. Between June, 1996, and January, 2000, HIV-1-infected mothers were randomised to one of four regimens: A, zidovudine plus lamivudine starting at 36 weeks' gestation, followed by oral intrapartum dosing and by 7 days' postpartum dosing of mothers and infants; B, as regimen A, but without the prepartum component; C, intrapartum zidovudine and lamivudine only; or placebo. From Feb 18, 1998, onward, women were only randomised to one of the active treatment groups. Primary outcomes were HIV-1 infection and child mortality at week 6 and month 18 after birth. Analysis was by intention to treat of those randomised before Feb 18, 1998.\n 1797 HIV-1-infected women were identified. Week 6 HIV-1 transmission rates were 5.7% for group A, 8.9% for group B, 14.2% for group C, and 15.3% for the placebo group. Respective relative risks for HIV-1 transmission in the treatment groups compared with placebo were 0.37 (95% CI 0.21-0.65), 0.58 (0.36-0.94), and 0.93 (0.62-1.40). For the combined endpoint of HIV-1 infection and infant mortality at week 6 rates were 7.0%, 11.6%, 17.5%, and 18.1%, respectively, with relative risks of 0.39 (0.24-0.64), 0.64 (0.42-0.97), and 0.97 (0.68-1.38). 1081 (74%) of the women analysed initiated breastfeeding. Based on an interval-censored survival analysis, HIV-1 infection rates at month 18 were 15% (95% CI 9-23), 18% (12-26), 20% (13-30) and 22% (16-30), respectively.\n Although at week 6 after birth, regimens A and B were effective in reducing HIV-1 transmission, benefits have diminished considerably after 18 months of follow-up. Introduction of short-course regimens to prevent mother-to-child transmission of HIV-1 in less-developed countries should be accompanied by interventions to minimise the risk of subsequent transmission via breastfeeding.", "To compare the effect of perinatal regimens of short-course nevirapine (HIVNET 012) and zidovudine [Thai-Centers for Disease Control and Prevention (CDC) regimen] on breast milk viral shedding and perinatal transmission during the first 6 weeks postpartum in a randomized clinical trial.\n Randomized clinical trial.\n Pregnant HIV-1 seropositive women in Nairobi, Kenya who planned to breastfeed were randomized to HIVNET 012 or Thai-CDC regimens. Two to four breast milk samples were collected each week between delivery and 6 weeks postpartum. Breast milk HIV-1 RNA was quantified using the Gen-Probe TMA assay. Infants were tested for HIV-1 DNA at birth and 6 weeks.\n From March to October 2003, 76 women were enrolled and 795 breast milk samples were collected from 60 women who were randomized and followed after delivery. Between 3 and 21 days postpartum, nevirapine was associated with significantly greater suppression of breast milk log10 HIV-1 RNA: days 3 to 7 (1.98 versus 2.42, P = 0.1); days 8 to 14 (1.78 versus 2.48, P = 0.005); days 15 to 21 (1.90 versus 2.97, P = 0.003). At 6 weeks, the HIV-1 perinatal transmission rate was significantly lower among those who took nevirapine than zidovudine (6.8% versus 30.3%, P = 0.02).\n Compared to a peripartum zidovudine regimen, nevirapine was significantly more likely to decrease HIV-1 RNA in breast milk during the first week and through the third week postpartum following single-dose administration, and corresponded with decreased transmission risk at 6 weeks. Sustained breast milk HIV-1 suppression may contribute to the ability of nevirapine to decrease perinatal transmission of HIV-1.", "Many developing countries have not implemented the AIDS Clinical Trials Group 076 zidovudine regimen for prevention of perinatal HIV-1 transmission because of its complexity and cost. We investigated the safety and efficacy of short-course oral zidovudine administered during late pregnancy and labour.\n In a randomised, double-blind, placebo-controlled trial, HIV-1-infected pregnant women at two Bangkok hospitals were randomly assigned placebo or one zidovudine 300 mg tablet twice daily from 36 weeks' gestation and every 3 h from onset of labour until delivery. Mothers were given infant formula and asked not to breastfeed. The main endpoint was babies' HIV-1-infection status, tested with HIV-1-DNA PCR at birth, 2 months, and 6 months. We measured maternal plasma viral concentrations by RNA PCR.\n Between May, 1996, and December, 1997, 397 women were randomised; 393 gave birth to 395 live-born babies. Median duration of antenatal treatment was 25 days, and median number of doses during labour was three. 99% of women took at least 90% of scheduled antenatal doses. Adverse events were similar in the study groups. Of 392 babies with at least one PCR test, 55 tested positive: 18 in the zidovudine group and 37 in the placebo group. The estimated transmission risks were 9.4% (95% CI 5.2-13.5) on zidovudine and 18.9% (13.2-24.2) on placebo (p=0.006; efficacy 50.1% [15.4-70.6]). Between enrolment and delivery, women in the zidovudine group had a mean decrease in viral load of 0.56 log. About 80% of the treatment effect was explained by lowered maternal viral concentrations at delivery.\n A short course of twice-daily oral zidovudine was safe and well tolerated and, in the absence of breastfeeding, can lessen the risk for mother-to-child HIV-1 transmission by half. This regimen could prevent many HIV-1 infections during late pregnancy and labour in less-developed countries unable to implement the full 076 regimen.", "Defining the effect of antiretroviral regimens on breast milk HIV type-1 (HIV-1) levels is useful to inform the rational design of strategies to decrease perinatal HIV-1 transmission.\n Pregnant HIV-1 seropositive women (CD4+ T-cell count >250 and <500 cells/mm3) electing to breastfeed in Nairobi, Kenya were randomized to highly active antiretroviral therapy (HAART; zidovudine [ZDV], lamivudine and nevirapine [NVP]) during pregnancy and 6 months post-partum or to short-course ZDV plus single-dose NVP (ZDV/NVP). Breast milk samples were collected two to three times per week in the first month post-partum.\n Between November 2003 and April 2006, 444 breast milk samples were collected from 58 randomized women during the first month after delivery. Between 3 and 14 days post-partum, women in the HAART and ZDV/NVP arms had a similar prevalence of undetectable breast milk HIV-1 RNA. From 15 to 28 days post-partum, women in the HAART arm had significantly lower levels of breast milk HIV-1 RNA than women randomized to ZDV/NVP (1.7 log10 copies/ml [limit of detection] versus >2.10 log10 copies/ml, P<0.001). In contrast to breast milk HIV-1 RNA, suppression of plasma HIV-1 RNA during the neonatal period was consistently several log10 greater in the HAART arm compared with the ZDV/NVP arm.\n HAART resulted in lower breast milk HIV-1 RNA than ZDV/NVP; however, ZDV/NVP yielded comparable breast milk HIV-1 RNA levels in the first 2 weeks post-partum. Breast milk HIV-1 RNA remained suppressed in the ZDV/NVP arm despite increased plasma HIV-1 levels, which might reflect local drug effects or compartmentalization.", "The most effective highly active antiretroviral therapy (HAART) to prevent mother-to-child transmission of human immunodeficiency virus type 1 (HIV-1) in pregnancy and its efficacy during breast-feeding are unknown.\n We randomly assigned 560 HIV-1-infected pregnant women (CD4+ count, > or = 200 cells per cubic millimeter) to receive coformulated abacavir, zidovudine, and lamivudine (the nucleoside reverse-transcriptase inhibitor [NRTI] group) or lopinavir-ritonavir plus zidovudine-lamivudine (the protease-inhibitor group) from 26 to 34 weeks' gestation through planned weaning by 6 months post partum. A total of 170 women with CD4+ counts of less than 200 cells per cubic millimeter received nevirapine plus zidovudine-lamivudine (the observational group). Infants received single-dose nevirapine and 4 weeks of zidovudine.\n The rate of virologic suppression to less than 400 copies per milliliter was high and did not differ significantly among the three groups at delivery (96% in the NRTI group, 93% in the protease-inhibitor group, and 94% in the observational group) or throughout the breast-feeding period (92% in the NRTI group, 93% in the protease-inhibitor group, and 95% in the observational group). By 6 months of age, 8 of 709 live-born infants (1.1%) were infected (95% confidence interval [CI], 0.5 to 2.2): 6 were infected in utero (4 in the NRTI group, 1 in the protease-inhibitor group, and 1 in the observational group), and 2 were infected during the breast-feeding period (in the NRTI group). Treatment-limiting adverse events occurred in 2% of women in the NRTI group, 2% of women in the protease-inhibitor group, and 11% of women in the observational group.\n All regimens of HAART from pregnancy through 6 months post partum resulted in high rates of virologic suppression, with an overall rate of mother-to-child transmission of 1.1%. (ClinicalTrials.gov number, NCT00270296.)\n 2010 Massachusetts Medical Society", "To determine the efficacy and safety of 2 inexpensive and easily deliverable antiretroviral (ARV) regimens for the prevention of mother-to-child transmission (MTCT) of human immunodeficiency virus (HIV) type 1 during labor and delivery, HIV-infected pregnant women were screened at 11 maternity health institutions in South Africa and were enrolled in an open-label short course ARV regimen of either nevirapine (Nvp) or multiple-dose zidovudine and lamivudine (Zdv/3TC). The overall estimated HIV-1 infection rates in 1307 infants by 8 weeks were 12.3% (95% confidence interval [CI], 9.7-15.0) for Nvp and 9.3% (95% CI, 7.0-11.6) for Zdv/3TC (P=.11). Excluding infections detected within 72 h (intrauterine), new HIV-1 infections were detected in 5.7% (95% CI, 3.7-7.8) and 3.6% (95% CI, 2.0-5.3) of infants in the Nvp and Zdv/3TC groups, respectively, in the 8 weeks after birth. There were no drug-related maternal or pediatric serious adverse events. Common complications were obstetrical for mothers (Nvp group, 24.3%; Zdv/3TC group, 26.3%) and respiratory for infants (Nvp group, 16.1%; Zdv/3TC group, 17.0%). This study further confirms the efficacy and safety of short-course ARV regimens in reducing MTCT rates in developing countries.", "A multicenter randomized, double blind, placebo-controlled clinical trial was conducted to evaluate the effectiveness of a short course of oral zidovudine (ZDV) treatment in HIV-1 infected pregnant women, starting at 38 weeks of gestation plus ZDV infusion during labor until delivery, to reduce HIV-1 vertical transmission in non-breast fed infants. One hundred and eighty two asymptomatic antiretroviral naïve HIV-1 infected pregnant women were enrolled. Each patient was randomly allocated into either the ZDV or placebo group. The ZDV group received 250 mg ZDV orally twice a day initiated at 38 weeks' gestation until the onset of labor. During the intrapartum period, ZDV infusion at the rate of 2 mg/kg was administered within the first hour and then continuously infused at the rate of 1 mg/kg/h until delivery. The placebo group received an identical capsule during pregnancy and normal saline infusion during labor until delivery. HIV-1 transmission was documented by nested polymerase chain reaction in infants at birth and at 1, 3 and, 6 months of age. The estimated HIV-1 vertical transmission rate was 14.9 per cent (95% CI = 11.1 to 18.7) and 16.3 per cent (95% CI = 12.3 to 20.9) in ZDV and placebo group, respectively (p > 0.05). The short course ZDV in antiretroviral naïve pregnant women initiated at 38 weeks' gestation plus intrapartum ZDV infusion without treatment in the infants was not effective to prevent HIV-1 vertical transmission." ]

[ "16505299", "15083437", "21051593", "21903010" ]

[ "Weight-supported treadmill vs over-ground training for walking after acute incomplete SCI.", "Functional electric stimulation to augment partial weight-bearing supported treadmill training for patients with acute incomplete spinal cord injury: A pilot study.", "Influence of a locomotor training approach on walking speed and distance in people with chronic spinal cord injury: a randomized clinical trial.", "Comparison of training methods to improve walking in persons with chronic spinal cord injury: a randomized clinical trial." ]

[ "To compare the efficacy of step training with body weight support on a treadmill (BWSTT) with over-ground practice to the efficacy of a defined over-ground mobility therapy (CONT) in patients with incomplete spinal cord injury (SCI) admitted for inpatient rehabilitation.\n A total of 146 subjects from six regional centers within 8 weeks of SCI were entered in a single-blinded, multicenter, randomized clinical trial (MRCT). Subjects were graded on the American Spinal Injury Association Impairment Scale (ASIA) as B, C, or D with levels from C5 to L3 and had a Functional Independence Measure for locomotion (FIM-L) score < 4. They received 12 weeks of equal time of BWSTT or CONT. Primary outcomes were FIM-L for ASIA B and C subjects and walking speed for ASIA C and D subjects 6 months after SCI.\n No significant differences were found at entry between treatment groups or at 6 months for FIM-L (n = 108) or walking speed and distance (n = 72). In the upper motor neuron (UMN) subjects, 35% of ASIA B, 92% of ASIA C, and all ASIA D subjects walked independently. Velocities for UMN ASIA C and D subjects were not significantly different for BWSTT (1.1 +/- 0.6 m/s, n = 30) and CONT (1.1 +/- 0.7, n = 25) groups.\n The physical therapy strategies of body weight support on a treadmill and defined overground mobility therapy did not produce different outcomes. This finding was partly due to the unexpectedly high percentage of American Spinal Injury Association C subjects who achieved functional walking speeds, irrespective of treatment. The results provide new insight into disability after incomplete spinal cord injury and affirm the importance of the multicenter, randomized clinical trial to test rehabilitation strategies.", "To study the application of partial weight-bearing (PWB) supported treadmill gait training augmented by functional electric stimulation (FES) in subjects with acute incomplete spinal cord injury (SCI).\n Before-after crossover trial with control (A) and intervention (B) periods.\n Physiotherapy (PT) department of a spinal injuries unit in Scotland.\n Fourteen inpatients with acute incomplete SCI with American Spinal Injury Association class C or D injury.\n Training consisted of treadmill walking with PWB support augmented by FES. Subjects walked on the treadmill for up to 25 minutes a day, 5 days a week for 4 weeks. The intervention was compared with a 4-week control period in which standard PT was given.\n Overground walking endurance and speed, cadence, stride length, and observational gait analysis and walking speed, distance, and percentage PWB support on the treadmill.\n A greater increase in overground walking endurance was achieved after the intervention (AB group mean, 72.2m; confidence interval [CI], 39.8-104.6m; BA group mean, 63.8m; CI, -10.2 to 137.9m), as compared with after standard PT (AB group mean, 38.4m; CI, 1.8-75.0m; BA group mean, 60.1m; CI, 9.2-110.9m). A similar pattern was observed for overground walking speed.\n This pilot study indicated that PWB supported treadmill training with FES had a positive effect on overground gait parameters and could potentially accelerate gait training in subjects with incomplete SCI. A larger randomized trial is required to substantiate these findings.", "Impaired walking limits function after spinal cord injury (SCI), but training-related improvements are possible even in people with chronic motor incomplete SCI.\n The objective of this study was to compare changes in walking speed and distance associated with 4 locomotor training approaches.\n This study was a single-blind, randomized clinical trial.\n This study was conducted in a rehabilitation research laboratory.\n Participants were people with minimal walking function due to chronic SCI.\n Participants (n=74) trained 5 days per week for 12 weeks with the following approaches: treadmill-based training with manual assistance (TM), treadmill-based training with stimulation (TS), overground training with stimulation (OG), and treadmill-based training with robotic assistance (LR).\n Overground walking speed and distance were the primary outcome measures.\n In participants who completed the training (n=64), there were overall effects for speed (effect size index [d]=0.33) and distance (d=0.35). For speed, there were no significant between-group differences; however, distance gains were greatest with OG. Effect sizes for speed and distance were largest with OG (d=0.43 and d=0.40, respectively). Effect sizes for speed were the same for TM and TS (d=0.28); there was no effect for LR. The effect size for distance was greater with TS (d=0.16) than with TM or LR, for which there was no effect. Ten participants who improved with training were retested at least 6 months after training; walking speed at this time was slower than that at the conclusion of training but remained faster than before training.\n It is unknown whether the training dosage and the emphasis on training speed were optimal. Robotic training that requires active participation would likely yield different results.\n In people with chronic motor incomplete SCI, walking speed improved with both overground training and treadmill-based training; however, walking distance improved to a greater extent with overground training.", "To compare two forms of device-specific training - body-weight-supported (BWS) ambulation on a fixed track (TRK) and BWS ambulation on a treadmill (TM) - to comprehensive physical therapy (PT) for improving walking speed in persons with chronic, motor-incomplete spinal cord injury (SCI).\n Thirty-five adult subjects with a history of chronic SCI (>1 year; AIS 'C' or 'D') participated in a 13-week (1 hour/day; 3 days per week) training program. Subjects were randomized into one of the three training groups. Subjects in the two BWS groups trained without the benefit of additional input from a physical therapist or gait expert. For each training session, performance values and heart rate were monitored. Pre- and post-training maximal 10-m walking speed, balance, muscle strength, fitness, and quality of life were assessed in each subject.\n All three training groups showed significant improvement in maximal walking speed, muscle strength, and psychological well-being. A significant improvement in balance was seen for PT and TRK groups but not for subjects in the TM group. In all groups, post-training measures of fitness, functional independence, and perceived health and vitality were unchanged.\n Our results demonstrate that persons with chronic, motor-incomplete SCI can improve walking ability and psychological well-being following a concentrated period of ambulation therapy, regardless of training method. Improvement in walking speed was associated with improved balance and muscle strength. In spite of the fact that we withheld any formal input of a physical therapist or gait expert from subjects in the device-specific training groups, these subjects did just as well as subjects receiving comprehensive PT for improving walking speed and strength. It is likely that further modest benefits would accrue to those subjects receiving a combination of device-specific training with input from a physical therapist or gait expert to guide that training." ]

[ "11826514", "11890590", "10723618" ]

[ "Questions elderly patients have about on-going therapy: a pilot study to assist in communication with physicians.", "The effects of patient communication skills training on the discourse of older patients during a primary care interview.", "Empowering older patients to communicate more effectively in the medical encounter." ]

[ "This pilot study examined the prevalence and types of questions elderly patients have about their current drug therapy. It also evaluated the effectiveness of a brief intervention to prepare patients to ask questions about drug therapy during medical visits.\n The research used a posttest-only experimental design. Forty-five elderly patients seen at a primary care clinic during a one-month period consented to participate and completed the study. After consent, subjects were randomly assigned to intervention and control conditions. A brief interview with intervention group subjects conducted by a medical student assigned to the clinic as part of a summer research experience helped subjects formulate questions they had about current therapy before they went into medical visits. Patient-physician visits were audiotaped and patient questions about medications and health care were tallied.\n Subjects in the intervention group were significantly more likely to ask questions of providers than were subjects in the control group. Intervention group subjects were found to ask a wider variety of medication-related questions than were control group subjects, including questions related to proper use, problems perceived with medications, and effectiveness of treatment.\n Assisting patients to formulate questions before medical visits results in an increased likelihood that patients will ask questions and will ask a wider variety of questions during the medical visit.", "To test the effects of a communication skills training intervention on older patients' discourse during a primary care interview.\n A quasi-experimental design involving two intervention conditions.\n The Family Practice Center of a university-based clinic.\n Thirty-three patients averaging age 72 and 9 family practice physicians.\n A communication skills training booklet received approximately 3 days before the scheduled appointment and a 30-minute face-to-face follow-up session before seeing the physician.\n Patients' seeking, providing, and verifying of information were coded from transcripts of the 33 interviews.\n Trained patients engaged in significantly more seeking and providing of information than untrained patients. Additionally, trained patients obtained significantly more information from physicians than did untrained patients, both in terms of the number of total information units and the number of units per question asked.\n Patient communication skills training appears to be an effective means of enhancing patients' participation in the medical interview without increasing the overall length of the interview.", "Active involvement of patients in medical encounters has been associated with several desirable outcomes, including greater satisfaction, increased adherence to treatment, and positive treatment outcomes. Older patients, particularly the very old and less well educated, are more likely to place physicians in a dominant role and themselves in a submissive role. Intervention trials to increase patient involvement have shown positive results. Activation interventions with older patients to increase a sense of control and self-efficacy are promising. Most of the attention to improving doctor-patient interaction has been directed toward physicians. The results of these few intervention trials support increased attention to patient behaviors." ]

[ "9647148", "2359570", "1835005", "7612535", "3685399", "8238173" ]

[ "Randomised comparative trial of the levonorgestrel intrauterine system and norethisterone for treatment of idiopathic menorrhagia.", "The effects of mefenamic acid and norethisterone on measured menstrual blood loss.", "A comparative study of danazol and norethisterone in dysfunctional uterine bleeding presenting as menorrhagia.", "Comparative study of tranexamic acid and norethisterone in the treatment of ovulatory menorrhagia.", "The effects of danazol, mefenamic acid, norethisterone and a progesterone-impregnated coil on endometrial prostaglandin concentrations in women with menorrhagia.", "A comparative study of danazol, a regimen of decreasing doses of danazol, and norethindrone in the treatment of objectively proven unexplained menorrhagia." ]

[ "To compare the efficacy and acceptability of the levonorgestrel intrauterine system and norethisterone for the treatment of idiopathic menorrhagia.\n A randomised comparative parallel group study.\n Gynaecology outpatient clinic in a teaching hospital.\n Forty-four women with heavy regular periods and a measured menstrual blood loss exceeding 80 ml.\n Twenty-two women had a levonorgestrel intrauterine system inserted within the first seven days of menses, and 22 women received norethisterone (5 mg three times daily) from day 5 to day 26 of the cycle for three cycles.\n The main outcome measure was the change in objectively assessed menstrual blood loss after three months of treatment.\n When menstrual blood loss at three months was expressed as a percentage of the control, the levonorgestrel intrauterine system reduced menstrual blood loss by 94% (median reduction 103 ml; range 70 to 733 ml), and oral norethisterone by 87% (median reduction 95 ml; range 56 to 212 ml). After three cycles of treatment 76% of the women in the levonorgestrel intrauterine system group wished to continue with the treatment, compared with only 22% of the norethisterone group.\n Both the levonorgestrel intrauterine system and oral norethisterone in this regimen provided an effective treatment for menorrhagia in terms of reducing menstrual blood loss to within normal limits. The levonorgestrel intrauterine system was associated with higher rates of satisfaction and continuation with treatment, and thus offers an effective alternative to currently available medical and surgical treatments for menorrhagia.", "Although there are numerous medical treatments for menorrhagia, in many instances neither the precise diagnosis nor the response to therapy have been assessed objectively. Menorrhagia (menstrual blood loss more than 80 mL per cycle) was diagnosed objectively in 32 (44%) of 72 women with a subjective complaint of heavy menses. All of the 32 women had ovulatory cycles. After random allocation to treatment with either mefenamic acid (500 mg three times daily during menses, N = 17) or norethisterone (5 mg twice daily on days 19-26 of the cycle, N = 15) for two additional cycles, the median menstrual blood loss was reduced from 123 mL (range 86-237) to 81 mL (22-193) (P less than .001) and from 109 mL (81-236) to 92 mL (43-189) (P less than .002) with mefenamic acid and norethisterone, respectively. Apart from a decrease in the median number of days of bleeding, from 7 (5-8) to 5 (3-8) in those women treated with mefenamic acid, no other differences were seen between the groups. We conclude that mefenamic acid and norethisterone were similarly effective in reducing the degree of menstrual blood loss in women with proved menorrhagia, but that 52 and 67% of the women, respectively, remained menorrhagic after 2 months of treatment.", "This randomized open study compared the efficacy and safety of norethisterone, 5 mg three times a day from day 19 to 26, and danazol, 200 mg daily, in the treatment of dysfunctional uterine bleeding presenting as menorrhagia. Clinical criteria were employed to confirm the diagnosis, and subjective assessment of the condition was performed during one pre-treatment and three treatment cycles. Fourteen patients commenced norethisterone and 10 danazol. Bleeding intensity scores were significantly lower with danazol than with norethisterone, and patients assessed their blood loss to be significantly less with danazol than with norethisterone. Associated symptoms of backache and abdominal pain were improved to a similar degree by both treatments. Adverse reactions were reported with similar frequency and were of a similar nature in both treatment groups.", "To compare the efficacy and safety of tranexamic acid and norethisterone in the treatment of ovulatory menorrhagia.\n A randomised, double-blind, placebo controlled study.\n University Department of Obstetrics and Gynaecology, Addenbrooke's Hospital, Cambridge.\n One hundred and three women complaining of heavy periods with a regular cycle recruited directly from general practitioners within the hospital catchment area and from consultants' gynaecology clinics.\n There were forty-six women on placebo with confirmed ovulatory menorrhagia, defined as menstrual blood loss greater than 80 ml/cycle and mid-luteal serum progesterone concentration greater than 9 nmol/l). Twenty-one received norethisterone (5 mg twice a day on days 19 and 26) and 25 received tranexamic acid (1 g four times daily on days 1 to 4) for two cycles.\n Menstrual blood loss was measured using the alkaline haematin method. Haematological assessments were made both at the beginning and at the end of the study, questionnaires were given to assess subjective endpoints, and patients were asked to report any adverse events during all cycles.\n Tranexamic acid reduced mean menstrual blood loss by 45%, from 175 ml to 97 ml (95% CI for the difference in menstrual blood loss 52 to 108, P < 0.0001), norethisterone increased mean blood loss by 20% from 173 ml to 208 ml (95% CI for the difference in menstrual blood loss -64 to 2, P = 0.26). Fourteen (56%) women who received tranexamic acid achieved a mean menstrual loss of less than 80 ml per cycle during treatment, but only two (9.5%) who received norethisterone achieved this mean menstrual loss. There were no serious adverse events reported for either drug.\n Tranexamic acid is a safe and effective form of medical therapy in women with menorrhagia and is highly likely to normalise blood loss in women losing 80 to 200 ml prior to treatment. Norethisterone at this dose is not effective therapy for ovulatory menorrhagia.", "The effects of four medical treatments have been assessed on menstrual blood loss (MBL) and endometrial prostaglandin (PG) concentrations in 30 women with objectively confirmed menorrhagia. Patients were randomly treated with danazol, 200 mg daily (n = 6), mefenamic acid, 500 mg three times daily during menses (n = 8), norethisterone, 5 mg twice daily from day 15-25 of the cycle (n = 8) or a progesterone-impregnated coil releasing 65 micrograms progesterone daily (n = 8). Endometrial biopsies were obtained in the mid-luteal phase before and after treatment in 23 cases, and assayed for PG content using radioimmunoassay. Treatment with norethisterone had no effect on either MBL or the concentration of PGs in the endometrium. MBL was significantly reduced after treatment with mefenamic acid (P = 0.05, n = 6) and the progesterone coil (P less than 0.05, n = 6), and was reduced in each of 4 cases treated with danazol in whom endometrial biopsies were available. Although there was no consistent change in endometrial PG concentrations in either the mefenamic acid or danazol groups, the lower MBL after insertion of the progesterone coil was associated with a reduced endometrial content of PGE, PGF2 alpha and \"total\" PG (6oxo PGF1 alpha + PGE + PGF2 alpha)-P = 0.05. Whereas the cyclooxygenase inhibitor mefenamic acid is likely to exert its effect on endometrial PGs at the time of menstruation itself, the continuous administration of progesterone throughout the menstrual cycle could result in both an impairment in estrogen receptor generation leading to reduced estrogen-mediated cyclooxygenase activity, and an increase in endometrial PG metabolism.", "Our purpose was to compare the efficacy of the recommended dose of danazol, a reduced-dose danazol regimen, and norethindrone in the treatment of objectively proven menorrhagia. Recurrence after discontinuing treatment was also assessed.\n The study was a single-blind, randomized, parallel, comparative study. After a placebo run-in period over two menstrual cycles, 57 patients with a baseline mean menstrual blood loss of at least 80 ml per cycle were randomly assigned to receive one of three therapies: danazol, 200 mg/day (n = 19) for three menstrual cycles; danazol, 200 mg/day for one cycle, 100 mg/day for one cycle, and 50 mg/day for one cycle (n = 19); and norethindrone, 5 mg three times daily on days 19 through 26 of the cycle for three consecutive cycles (n = 19). Patients in whom treatment was successful (those experiencing blood loss < 80 ml) were entered in the follow-up phase of the study, receiving placebo for a maximum of four menstrual cycles.\n The final menstrual blood loss on treatment was significantly less for those patients who received both danazol regimens compared with those who received norethindrone (p = 0.017 for reducing dose danazol vs norethindrone and p = 0.043 for 200 mg of danazol vs norethindrone). Both danazol treatment regimens were significantly more successful in reducing menstrual blood loss to within the normal range than was norethindrone. The reducing-dose danazol regimen was successful in eight of 17 patients (p = 0.027), and 200 mg of danazol was successful in nine of 19 patients (p = 0.029), compared with the two successes of 18 patients treated with norethindrone. Significantly more recipients of 200 mg of danazol than of norethindrone subjectively rated their treatment to be moderately or highly effective (p = 0.033). Both danazol treatment regimens were associated with a higher incidence of adverse events than was norethindrone therapy, although the number of withdrawals were similar and infrequent in the three groups.\n Both danazol regimens were significantly more effective than norethindrone in reducing the excessive menstrual blood loss of women with unexplained menorrhagia. A subjective assessment by patients found that only the 200 mg of danazol was judged to be significantly more effective than norethindrone in controlling the heaviness of menstrual bleeding. The reduced-dose danazol regimen did not appear to markedly diminish the incidence of adverse events compared with the 200 mg of danazol regimen." ]

[ "9404379", "8630593", "10543292", "16421364", "11684212", "6767295" ]

[ "Effect of increasing doses of hypertonic saline on mucociliary clearance in patients with cystic fibrosis.", "Effect of hypertonic saline, amiloride, and cough on mucociliary clearance in patients with cystic fibrosis.", "The effect of inhaled mannitol on bronchial mucus clearance in cystic fibrosis patients: a pilot study.", "A controlled trial of long-term inhaled hypertonic saline in patients with cystic fibrosis.", "Comparison of hypertonic saline and alternate-day or daily recombinant human deoxyribonuclease in children with cystic fibrosis: a randomised trial.", "Controlled trial of intermittent aerosol therapy with sodium 2-mercaptoethane sulphonate in cystic fibrosis." ]

[ "Patients with cystic fibrosis are known to have decreased mucociliary clearance. It has previously been shown that inhalation of a 7.0% solution of hypertonic saline significantly improved mucociliary clearance in a group of adult patients with cystic fibrosis. The aim of this study was to measure the response to increasing concentrations of inhaled hypertonic saline.\n Ten patients (seven men) of mean (SE) age 22 (4) years and mean forced expiratory volume in one second (FEV1) 52.0 (6.7)% predicted completed the study. Mucociliary clearance was measured using a radioaerosol technique for 90 minutes after the interventions which comprised 0.9% NaCl + voluntary cough (control), 3.0% NaCl, 7.0% NaCl, and 12% NaCl.\n There was a significant increase in the amount of activity cleared from the right lung with all concentrations of hypertonic saline (HS) compared with control. The amount cleared at 90 minutes on the control day was 12.7% (95% confidence interval (CI) 9.8 to 17.2) compared with 19.7% (95% CI 13.6 to 29.5) for 3% HS, 23.8% (95% CI 15.9 to 36.7) for 7% HS and 26.0% (95% CI 19.8 to 35.9) for 12% HS. The improvement in mucociliary clearance was not solely due to coughing as the number of coughs recorded on the control day exceeded that recorded on any other day. The hypertonic saline did not induce a clinically significant change in FEV1.\n Within the range of concentrations examined in this study, the effect of hypertonic saline appears to be dose dependent. Inhalation of hypertonic saline remains a potentially useful treatment for patients with cystic fibrosis.", "In patients with cystic fibrosis (CF), dehydration of airway secretions leads to a decrease in mucociliary clearance (MCC). We examined the acute effect of MCC of a single administration by aerosolization of hypertonic saline (7%) (HS), amiloride (0.3% in 0.12% NaCl) (AML) and a combination of AML and HS (AML + HS) in 12 patients with CF using a radioaerosol technique. Isotonic saline [0.9%] (IS) was used as a control solution. As both the AML and HS solutions induced cough in some patients, the last nine patients studied also underwent a cough clearance day. This was to eliminate the possible confounding effect of cough on MCC measurement. Patients ranged from 18 to 28 yr (mean +/- SD, 22 +/- 3) with an FEV1 of 27 to 112% predicted (61 +/- 30%). Following deposition of the radioaerosol, baseline clearance was assessed for 30 min. This was followed by a 30-min intervention period. Assessment of post-intervention clearance for a further 30 min was then performed. Comparison of the amount of radioaerosol cleared from the right lung was made at 60 min (%C60) and 90 min (%C90) using repeated measures ANOVA. The percent cleared at 60 and 90 min was significantly increased with HS (%C60 = 26.5%, %C90 = 29.4%) and the combination of AML + HS (%C60 = 23.1%, %C90 = 27.4%) compared with both IS (%C60 = 14.7%, %C90 = 17.5%) and COUGH (%C60 = 18.0%, %C90 = 19.5%), p < 0.01. Inhalation of hypertonic saline is a potentially useful treatment in patients with cystic fibrosis.", "It has been postulated that hypertonic saline (HS) might impair the antimicrobial effects of defensins within the airways. Alternative non-ionic osmotic agents such as mannitol may thus be preferable to HS in promoting bronchial mucus clearance (BMC) in patients with cystic fibrosis (CF). This study reports the effect of inhalation of another osmotic agent, dry powder Mannitol (300 mg), compared with its control (empty capsules plus matched voluntary cough) and a 6% solution of HS on BMC in 12 patients with cystic fibrosis (CF). Mucus clearance was measured using a radioaerosol/gamma camera technique. Post-intervention clearance was measured for 60 min, followed by cough clearance for 30 min. Neither mannitol nor HS improved BMC during the actual intervention period compared with their respective controls. However during the post-intervention measurement there was a significant improvement in BMC for both the mannitol (8.7+/-3.3% versus 2.8+/-0.7%) and HS (10.0+/-2.3% versus 3.5+/-0.8%). There was also a significant improvement in cough clearance with the Mannitol (9.7+/-2.4%) compared with its control (2.5+/-0.8%). Despite premedication with a bronchodilator, a small fall in forced expiratory volume in one second (FEV1) was seen immediately after administration of both the mannitol (7.3+/-2.5%) and HS (5.8+/-1.2%). Values of FEV1 returned to baseline by the end of the study. Inhaled mannitol is a potential mucoactive agent in cystic fibrosis patients. Further studies are required to establish the optimal dose and the long-term effectiveness of mannitol.", "Inhaled hypertonic saline acutely increases mucociliary clearance and, in short-term trials, improves lung function in people with cystic fibrosis. We tested the safety and efficacy of inhaled hypertonic saline in a long-term trial.\n In this double-blind, parallel-group trial, 164 patients with stable cystic fibrosis who were at least six years old were randomly assigned to inhale 4 ml of either 7 percent hypertonic saline or 0.9 percent (control) saline twice daily for 48 weeks, with quinine sulfate (0.25 mg per milliliter) added to each solution to mask the taste. A bronchodilator was given before each dose, and other standard therapies were continued during the trial.\n The primary outcome measure, the rate of change (slope) in lung function (reflected by the forced vital capacity [FVC], forced expiratory volume in one second [FEV1], and forced expiratory flow at 25 to 75 percent of FVC [FEF25-75]) during the 48 weeks of treatment, did not differ significantly between groups (P=0.79). However, the absolute difference in lung function between groups was significant (P=0.03) when averaged across all post-randomization visits in the 48-week treatment period. As compared with the control group, the hypertonic-saline group had significantly higher FVC (by 82 ml; 95 percent confidence interval, 12 to 153) and FEV1 (by 68 ml; 95 percent confidence interval, 3 to 132) values, but similar FEF25-75 values. The hypertonic-saline group also had significantly fewer pulmonary exacerbations (relative reduction, 56 percent; P=0.02) and a significantly higher percentage of patients without exacerbations (76 percent, as compared with 62 percent in the control group; P=0.03). Hypertonic saline was not associated with worsening bacterial infection or inflammation.\n Hypertonic saline preceded by a bronchodilator is an inexpensive, safe, and effective additional therapy for patients with cystic fibrosis. (ClinicalTrials.gov number, NCT00271310.)\n Copyright 2006 Massachusetts Medical Society.", "Daily recombinant human deoxyribonuclease (rhDNase) is an established but expensive treatment in cystic fibrosis. Alternate-day treatment, if equally effective, would reduce the drug cost. Hypertonic saline improved lung function to the same degree as rhDNase in short-term studies. We compared the effectiveness of daily rhDNase, hypertonic saline, and alternate-day rhDNase in children with cystic fibrosis.\n In an open cross-over trial, 48 children were allocated in random order to 12 weeks of once-daily rhDNase (2.5 mg), alternate-day rhDNase (2.5 mg), and twice-daily 5 mL 7% hypertonic saline. The primary outcome was forced expiratory volume in 1 s (FEV(1)). Secondary outcomes were forced vital capacity, number of pulmonary exacerbations, weight gain, quality of life, exercise tolerance, and the total costs of hospital and community care.\n Mean FEV(1) increased by 16% (SD 25%), 14% (22%), and 3% (21%) with daily rhDNase, alternate-day rhDNase, and hypertonic saline, respectively. There was no difference between daily and alternate-day rhDNase (2% [95% CI -4 to 9], p=0.55). However, daily rhDNase showed a significantly greater increase in FEV(1) than hypertonic saline (8% [2 to 14], p=0.01). The average difference in 12-week cost between daily and alternate-day rhDNase was pound513 (95% CI -546 to 1510) and that between daily rhDNase and hypertonic saline was pound1409 (440 to 2318). None of the secondary clinical outcomes showed significant differences between treatments.\n Hypertonic saline, delivered by jet nebuliser, is not as effective as daily rhDNase, although there is variation in individual response. There is no evidence of a difference between daily and alternate-day rhDNase.", "Twenty-seven patients with cystic fibrosis completed a controlled trial comparing the effects of an inhaled mucolytic drug, sodium-2-mercaptoethane sulphonate (Mistabron, UCB Pharmaceutical Division, Brussels, Belgium), with inhaled iso-osmolar hypertonic saline. As a group the 22 patients with chronic sputum production showed small but statistically significant improvement in pulmonary function tests after Mistabron therapy, both when compared with a control period, and with iso-osmolar saline results. Subjective measurements by diary card failed to show any changes. No significant changes were found in five patients with no measurable sputum production. The inhalations were given after physiotherapy and were well tolerated. There were no significant side effects. The results suggest that Mistabron has a beneficial therapeutic effect unrelated to its high osmolality, and the intermittent inhalation of Mistabron may have a role in the treatment of selected patients with cystic fibrosis." ]

[ "11083312", "3939598", "11129741", "9407576", "9180668", "7715644", "11129745" ]

[ "Geriatric-based versus general wards for older acute medical patients: a randomized comparison of outcomes and use of resources.", "Acute care delivery for the geriatric patient: an innovative approach.", "A randomized controlled trial of exercise to improve outcomes of acute hospitalization in older adults.", "A randomized trial of geriatric liaison intervention in elderly medical inpatients.", "Do acute care for elders units increase hospital costs? A cost analysis using the hospital perspective.", "A randomized trial of care in a hospital medical unit especially designed to improve the functional outcomes of acutely ill older patients.", "Effects of a multicomponent intervention on functional outcomes and process of care in hospitalized older patients: a randomized controlled trial of Acute Care for Elders (ACE) in a community hospital." ]

[ "The effects of residence in an acute geriatrics-based ward (AGW) with emphasis on early rehabilitation and discharge planning for older patients with acute medical illnesses were assessed. Outcome and use of resources were compared with those of patients treated in general medical wards (MWs). A per-protocol rather than intention-to-treat analysis was performed.\n A randomized trial with 3-months follow-up. A total of 190 patients aged 70 years and older were randomized to an acute geriatrics-based ward, and 223 patients were randomized to general medical wards.\n The two groups were comparable at inclusion. However, after care in the AGW, 71% of patients could be discharged directly home compared with 64% of those treated in MWs (relative risk 1.17; 95% CI, 0.93-1.49). The length of stay was shorter in the AGW (mean 5.9 vs 7.3 days; P = .002). The proportion of patients in geriatric or other hospital wards or in nursing homes did not differ, but the proportion of AGW patients in sheltered living tended to be lower (P = .085). At the follow-up, case fatality, ADL function, psychological well-being, need for daily personal assistance, drug consumption, need for readmission to hospital, and total health care costs after discharge did not differ between the two groups. Poor global outcome was observed in 37% of AGW and 34% of MW patients.\n A geriatric approach with greater emphasis on early rehabilitation and discharge planning in the AGW shortened the length of hospital stay and may have reduced the need for long-term institutional living. This occurred despite patients in an acute geriatric ward not having better medical or functional outcome than older acute patients treated in general medical wards.", "As the elderly population and expenditures for health care continue to grow rapidly in the United States, how to provide high-quality, cost-effective geriatric care is becoming a pressing question. To address this question, Choate-Symmes Health Services, Inc, established 10-bed Geriatric Special Care Units (GSCUs) in its two suburban Boston hospitals. Care on the GSCUs is delivered under a primary nursing model and involves comprehensive assessment, development of individual care plans emphasizing independence and activity, an interdisciplinary patient care team, and family participation in care planning. Patients were randomly assigned to either the GSCU or a traditional adult medical/surgical unit; outcomes were studied through questionnaires and medical record data. Researchers anticipated improved functional ability, less frequent use of restraints, fewer complications, shorter lengths of stay, and less frequent readmission to the hospital or admission to nursing homes for GSCU patients. The article presents preliminary results, discusses implementation issues, and describes plans for continued study.", "Older adults hospitalized for nondisabling diagnoses can lose functional ability. Lack of exercise or physical activity during the acute illness and recovery may be contributory. This study evaluated whether increased exercise in hospital and afterward would shorten length of stay and improve physical function at 1 month.\n A randomized controlled trial.\n A 700-bed community-based hospital with academic and teaching programs.\n Three hundred patients (mean age 78.2 years +/- 5.6) with nondisabling medical and surgical diagnoses who were admitted to an acute care hospital between December 1990 and April 1992. All patients had an expected length of stay 5 or more days, were ambulatory before admission, and were not expected to die within 12 months.\n A hospital-based general exercise program was administered to intervention patients along with encouragement to continue the program, self-administered, at home.\n The primary outcome was hospital length of stay. Secondary outcomes at 1 month post-discharge included measures of physical function and other general health indicators.\n There was no significant difference in length of stay between treatment and control groups controlling for baseline characteristics and diagnoses. The intervention was associated with better function in instrumental activities of daily living (beta = .433 (95% CI, 0.044-0.842)) at 1 month but no change in perceived general health status and other measures of physical function.\n An exercise program started during hospitalization and continued for 1 month did not shorten length of stay but did improve functional outcome at 1 month.", "The aim of this study was to examine the effect of psychogeriatric intervention in a group of elderly medical inpatients over 75 years of age. In addition to usual care, intervention consisted of multidisciplinary joint treatment by a psychogeriatric team. The main purpose of intervention was to obtain the optimal level of physical functioning.\n In a prospective randomized trial the effect of the intervention (N = 140) compared with usual care (N = 97) was estimated for physical functioning, length of stay, and nursing home placement within 12 months of discharge.\n Substantially more patients assigned to the intervention group improved in their physical functioning, and fewer became worse. The mean length of stay was 5 days shorter for the intervention group. There were more readmissions to hospital in the usual care group (29.9%) compared with the intervention group (17.4%). Of the patients assigned to the intervention treatment, 18% were admitted to a nursing home. In the usual care group this was 27%. The effects of intervention remained statistically significant for all the outcome variables after controlling for possible confounding baseline characteristics.\n The intervention we studied had clinically relevant effects on important outcome variables. Psychiatric co-morbidity was an important risk factor for the outcome of the patients in our study. By combining elements from a psychiatric and geriatric consultation service with elements from a unit-driven service, we were able to improve health care for the elderly in our hospital in a feasible and cost-effective way.", "To compare the hospital costs of caring for medical patients on a special unit designed to help older people maintain or achieve independence in self-care activities with the costs of usual care.\n A randomized controlled study.\n A total of 650 medical patients (mean age 80 years, 67% women, 41% nonwhite) assigned randomly to either the intervention unit (n = 326) or usual care (n = 324).\n The hospital's resource-based cost of caring for patients was determined from the hospital's cost-accounting system. The cost of the intervention program was estimated and included in the intervention patients' total hospital cost.\n The development and maintenance costs of the intervention added $38.43 per bed day to the intervention patients' hospital costs. As a result, the cost per day to the hospital was slightly higher in the intervention patients than in the control patients ($876 vs $847, P = .076). However, the average length of stay was shorter for intervention patients (7.5 vs 8.4 days, P = .449). As a result, the hospital's total cost to care for intervention patients was not greater than caring for usual-care patients ($6608 in intervention patients vs $7240 in control patients, P = .926). Sensitivity analysis demonstrated that the cost of the intervention program would need to be 220% greater than estimated before intervention patients would be more expensive then control patients. There were no examined subgroups of patients in whom care on the intervention unit was significantly more expensive than care on the usual-care unit. Ninety-day nursing home use was lower in intervention than control patients (24.1% vs 32.3%, P = .034). Ninety-day readmission rates (36.7% vs 41.1%, P = .283) and caregiver strain scores (3.3 vs. 2.7, P = .280) were similar.\n Caring for patients on an intervention ward designed to improve functional outcomes in older patients was not more expensive to the hospital than caring for patients on a usual-care ward even though the intervention ward required a commitment of hospital resources.", "Older persons who re hospitalized for acute illnesses often lose their independence and are discharged to institutions for long-term care.\n We studied 651 patients 70 years of age or older who were admitted for general medical care at a teaching hospital; these patients were randomly assigned to receive usual care or to be cared for in a special unit designed to help older persons maintain or achieve independence in self-care activities. The key elements of this program were a specially prepared environment (with, for example, uncluttered hallways, large clocks and calendars, and handrails); patient-centered care emphasizing independence, including specific protocols for prevention of disability and for rehabilitation; discharge planning with the goal of returning the patient to his or her home; and intensive review of medical care to minimize the adverse effects of procedures and medications. The main outcome we measured ws the change from admission to discharge in the number of five basic activities of daily living (bathing, getting dressed, using the toilet, moving from a bed to a chair, and eating) that the patient could perform independently.\n Twenty-four patients in each group died in the hospital. At the time of discharge, 65 (21 percent) of the 303 surviving patients in the intervention group were classified as much better in terms of their ability to perform basic activities of daily living, 39 (13 percent) as better, 151 (50 percent) as unchanged, 22 (7 percent) as worse, and 26 (9 percent) as much worse. In the usual care group, 40 (13 percent) of the 300 surviving patients were classified as much better, 33 (11 percent) as better, 163 (54 percent) as unchanged, 39 (13 percent) as worse, and 25 (8 percent) as much worse (P = 0.009). The difference between the groups remained significant (P = 0.04) in a multivariable model in which we controlled for potentially confounding base-line characteristics of the patients. Lengths of stay and hospital charges were similar in the two groups. Fewer patients assigned to the intervention group were discharged to long-term care institutions (43 patients [14 percent], as compared with 67 patients [22 percent] in the usual-care group; P = 0.01). Among the 493 patients discharged to private homes, similar proportions (about 10 percent) in the two groups were admitted to long-term care institutions during the three months after discharge.\n Specific changes in the provision of acute hospital care can improve the ability of a heterogeneous group of acutely ill older patients to perform basic activities of daily living at the time of discharge from the hospital and can reduce the frequency of discharge to institutions for long-term care.", "Older persons frequently experience a decline in function following an acute medical illness and hospitalization.\n To test the hypothesis that a multicomponent intervention, called Acute Care for Elders (ACE), will improve functional outcomes and the process of care in hospitalized older patients.\n Randomized controlled trial.\n Community teaching hospital.\n A total of 1,531 community-dwelling patients, aged 70 or older, admitted for an acute medical illness between November 1994 and May 1997.\n ACE includes a specially designed environment (with, for example, carpeting and uncluttered hallways); patient-centered care, including nursing care plans for prevention of disability and rehabilitation; planning for patient discharge to home; and review of medical care to prevent iatrogenic illness.\n The main outcome was change in the number of independent activities of daily living (ADL) from 2 weeks before admission (baseline) to discharge. Secondary outcomes included resource use, implementation of orders to promote function, and patient and provider satisfaction.\n Self-reported measures of function did not differ at discharge between the intervention and usual care groups by intention-to-treat analysis. The composite outcome of ADL decline from baseline or nursing home placement was less frequent in the intervention group at discharge (34% vs 40%; P = .027) and during the year following hospitalization (P = .022). There were no significant group differences in hospital length of stay and costs, home healthcare visits, or readmissions. Nursing care plans to promote independent function were more often implemented in the intervention group (79% vs 50%; P = .001), physical therapy consults were obtained more frequently (42% vs 36%; P = .027), and restraints were applied to fewer patients (2% vs 6%; P = .001). Satisfaction with care was higher for the intervention group than the usual care group among patients, caregivers, physicians, and nurses (P < .05).\n ACE in a community hospital improved the process of care and patient and provider satisfaction without increasing hospital length of stay or costs. A lower frequency of the composite outcome ADL decline or nursing home placement may indicate potentially beneficial effects on patient outcomes." ]

[ "18181695", "19298993", "20687955", "18656217", "22096081", "20586966", "20877631", "19939445", "20923956", "21997488", "20683336", "20163349" ]

[ "Implementing antiretroviral therapy in rural communities: the Lusikisiki model of decentralized HIV/AIDS care.", "Patient retention and attrition on antiretroviral treatment at district level in rural Malawi.", "Nurse led, primary care based antiretroviral treatment versus hospital care: a controlled prospective study in Swaziland.", "Provision of antiretroviral therapy to children within the public sector of South Africa.", "Effectiveness and acceptability of delivery of antiretroviral treatment in health centres by health officers and nurses in Ethiopia.", "Outcome assessment of decentralization of antiretroviral therapy provision in a rural district of Malawi using an integrated primary care model.", "Better antiretroviral therapy outcomes at primary healthcare facilities: an evaluation of three tiers of ART services in four South African provinces.", "Rates of virological failure in patients treated in a home-based versus a facility-based HIV-care model in Jinja, southeast Uganda: a cluster-randomised equivalence trial.", "Outcomes of antiretroviral treatment: a comparison between hospitals and health centers in Ethiopia.", "Outcomes of stable HIV-positive patients down-referred from a doctor-managed antiretroviral therapy clinic to a nurse-managed primary health clinic for monitoring and treatment.", "Task-shifting of antiretroviral delivery from health care workers to persons living with HIV/AIDS: clinical outcomes of a community-based program in Kenya.", "Results of a community-based antiretroviral treatment program for HIV-1 infection in Western Uganda." ]

[ "Health worker shortages are a major bottleneck to scaling up antiretroviral therapy (ART), particularly in rural areas. In Lusikisiki, a rural area of South Africa with a population of 150,000 serviced by 1 hospital and 12 clinics, Médecins Sans Frontières has been supporting a program to deliver human immunodeficiency virus (HIV) services through decentralization to primary health care clinics, task shifting (including nurse-initiated as opposed to physician-initiated treatment), and community support. This approach has allowed for a rapid scale-up of treatment with satisfactory outcomes. Although the general approach in South Africa is to provide ART through hospitals-which seriously limits access for many people, if not the majority of people-1-year outcomes in Lusikisiki are comparable in the clinics and hospital. The greater proximity and acceptability of services at the clinic level has led to a faster enrollment of people into treatment and better retention of patients in treatment (2% vs. 19% lost to follow-up). In all, 2200 people were receiving ART in Lusikisiki in 2006, which represents 95% coverage. Maintaining quality and coverage will require increased resource input from the public sector and full acceptance of creative approaches to implementation, including task shifting and community involvement.", "We report on rates of patient retention and attrition in the context of scaling-up antiretroviral treatment (ART) within a district hospital and its primary health centres in rural Malawi. 'Retention' was defined as being alive and on ART or transferred out, whereas 'attrition' was defined as died, lost to follow-up or stopped treatment. A total of 4074 patients were followed-up for 1803 person-years: 2904 were at the hospital and 1170 at health centres. Approximately 85% of patients were retained in care, both at hospital and health centres, with a retention rate per 100 person-years of 185 and 211, respectively [adjusted hazard ratio (HR) 1.18, 95% CI 1.10-1.28, P=0.001). Attrition rates per 100 person-years were similar: 33 and 36, respectively (adjusted HR 1.17, 95% CI 0.97-1.4, P=0.1). At health centres the incidence of loss to follow-up was significantly lower than at the hospital (adjusted HR 0.24, P<0.001, risk reduction 77%), but the rate of reported deaths was higher at health centres (adjusted HR 2.2, 95% CI 1.76-2.72, P<0.001). As Malawi continues to extend the coverage (and equity) of ART, including in rural areas, attention is needed to reduce losses to follow-up at hospital level and reduce mortality at primary care level.", "Antiretroviral treatment services delivered in hospital settings in Africa increasingly lack capacity to meet demand and are difficult to access by patients. We evaluate the effectiveness of nurse led primary care based antiretroviral treatment by comparison with usual hospital care in a typical rural sub Saharan African setting.\n We undertook a prospective, controlled evaluation of planned service change in Lubombo, Swaziland. Clinically stable adults with a CD4 count > 100 and on antiretroviral treatment for at least four weeks at the district hospital were assigned to either nurse led primary care based antiretroviral treatment care or usual hospital care. Assignment depended on the location of the nearest primary care clinic. The main outcome measures were clinic attendance and patient experience.\n Those receiving primary care based treatment were less likely to miss an appointment compared with those continuing to receive hospital care (RR 0.37, p < 0.0001). Average travel cost was half that of those receiving hospital care (p = 0.001). Those receiving primary care based, nurse led care were more likely to be satisfied in the ability of staff to manage their condition (RR 1.23, p = 0.003). There was no significant difference in loss to follow-up or other health related outcomes in modified intention to treat analysis. Multilevel, multivariable regression identified little inter-cluster variation.\n Clinic attendance and patient experience are better with nurse led primary care based antiretroviral treatment care than with hospital care; health related outcomes appear equally good. This evidence supports efforts of the WHO to scale-up universal access to antiretroviral treatment in sub Saharan Africa.", "The South African Department of Health has embraced the primary health care approach in the provision of antiretroviral therapy (ART) to children. This paper compares clinical outcomes of children treated at primary healthcare clinics, district hospitals, and secondary and tertiary hospitals. A retrospective review of routine data captured by the provincial antiretroviral monitoring system was completed. Simplified cohort analysis was used to determine the cumulative incidence of baseline characteristics and outcomes. Data on 1741 children started at level 2 & 3, level 1 and primary healthcare clinic facilities between April 2004 and April 2006 were analysed. Kaplan-Meier survival estimates for these groups were 0.88 (95% CI 0.86-0.90), 0.94 (95% CI 0.89-0.97) and 0.94 (95% CI 0.89-0.96) at 12 months of ART, respectively, on intention-to-treat analysis. The overall cumulative proportion of children with a suppressed viral load was 73% (95% CI 69-77%) at 12 months of ART. There was no significant difference in viral load suppression rates between the three groups. This study confirms the feasibility of providing antiretrovirals at all levels of the healthcare service in the Western Cape. The higher death rates at level 2 & 3 facilities are most likely due to recruitment of sicker patients at this level.", "The World Health Organization (WHO) recommends shifting tasks from physicians to lower cadres for the delivery of antiretroviral treatment (ART) for countries short of physicians. Our objective was to evaluate the effectiveness and acceptability of ART delivery by health officers and nurses in Ethiopia.\n A retrospective cohort study to evaluate outcomes of ART services in 25 health centres staffed with health officers and/or nurses and 30 hospitals staffed with physicians in 2009. Median CD4-cell counts, mortality, loss to follow-up and retention were the primary outcomes. Interviews and focus group discussions were conducted with people living with HIV/AIDS, AIDS programme managers and health care providers to identify the types and acceptability of the tasks conducted by the health officers, nurses and community health workers.\n Health officers and nurses were providing ART, including ART prescription, for non-severe cases. The management of severe cases was exclusively the task of physicians. Community health workers were involved in adherence counselling and defaulter tracing. The baseline median CD4-cell counts per micro-liter of blood were 117 (interquartiles [IQ] 64,188) and 119 (IQ 67,190) at health centres and hospitals respectively. After 24 months on ART, the median CD4-cell counts per micro-liter of blood increased to 321 (IQ 242, 414) and 301 (IQ 217, 411) at health centres and hospitals respectively. Retention in care was higher in health centres (76%, 95% confidence interval [CI] [73%-79%]) than hospitals (67%, 95% CI [66%-68%]). This difference is mainly due to the higher loss to follow-up rate in hospitals (25% versus 13%). Mortality was higher in health centres than hospitals (11% versus 8%), but the difference is not statistically significant. Service delivery by non-physicians was accepted by patients, health care providers and programme managers. However, the absence of a regulatory framework for task shifting, the lack of extra remuneration for the additional roles assumed by nurses and health officers, and the high cost for training and mentorship were identified as weaknesses.\n ART delivery in health centres, based on health officers and nurses is feasible, effective and acceptable in Ethiopia. However, issues related to regulation, remuneration and cost need to be addressed for the sustainable implementation of these delivery models.", "To assess the effect of decentralization (DC) of antiretroviral therapy (ART) provision in a rural district of Malawi using an integrated primary care model.\n Between October 2004 and December 2008, 8093 patients (63% women) were registered for ART. Of these, 3440 (43%) were decentralized to health centres for follow-up ART care. We applied multivariate regression analysis that adjusted for sex, age, clinical stage at initiation, type of regimen, presence of side effects because of ART, and duration of treatment and follow-up at site of analysis.\n Patients managed at health centres had lower mortality [adjusted OR 0.19 (95% C.I. 0.15-0.25)] and lower loss to follow-up (defaulted from treatment) [adjusted OR 0.48 (95% C.I. 0.40-0.58)]. During the first 10 months of follow-up, those decentralized to health centres were approximately 60% less likely to default than those not decentralized; and after 10 months of follow-up, 40% less likely to default. DC was significantly associated with a reduced risk of death from 0 to 25 months of follow-up. The lower mortality may be explained by the selection of stable patients for DC, and the mentorship and supportive supervision of lower cadre health workers to identify and refer complicated cases.\n Decentralization of follow-up ART care to rural health facilities, using an integrated primary care model, appears a safe and effective way to rapidly scale-up ART and improves both geographical equity in access to HIV-related services and adherence to ART.", "There are conflicting reports of antiretroviral therapy (ART) effectiveness comparisons between primary healthcare (PHC) facilities and hospitals in low-income settings. This comparison has not been evaluated on a broad scale in South Africa.\n A retrospective cohort study was conducted including ART-naïve adults from 59 facilities in four provinces in South Africa, enrolled between 2004 and 2007. Kaplan-Meier estimates, competing-risks Cox regression, generalised estimating equation population-averaged models and logistic regression were used to compare death, loss to follow-up (LTFU) and virological suppression (VS) between PHC, district and regional hospitals. 29 203 adults from 47 PHC facilities, nine district hospitals and three regional hospitals were included. Patients at PHC facilities had more advanced WHO stage disease when starting ART. Retention in care was 80.1% (95% CI: 79.3%-80.8%), 71.5% (95% CI: 69.1%-73.8%) and 68.7% (95% CI: 67.0%-69.7%) at PHC, district and regional hospitals respectively, after 24 months of treatment (P<0.0001). In adjusted regression analyses, LTFU was independently increased at regional hospitals (aHR 2.19; 95% CI: 1.94-2.47) and mortality was independently elevated at district hospitals (aHR 1.60; 95% CI: 1.30-1.99) compared to PHC facilities after 12 months of ART. District and regional hospital patients had independently reduced probabilities of VS, aOR 0.76 (95% CI: 0.59-0.97) and 0.64 (95% CI: 0.56-0.75) respectively compared to PHC facilities over 24 months of treatment.\n ART outcomes were superior at PHC facilities, despite PHC patients having more advanced clinical stage disease when starting ART, suggesting that ART can be adequately provided at this level and supporting the South African government's call for rapid up-scaling of ART at the primary level of care. Further prospective research is required to determine the degree to which outcome differences are attributable to either facility level characteristics or patient co-morbidity at hospital level.", "Identification of new ways to increase access to antiretroviral therapy in Africa is an urgent priority. We assessed whether home-based HIV care was as effective as was facility-based care.\n We undertook a cluster-randomised equivalence trial in Jinja, Uganda. 44 geographical areas in nine strata, defined according to ratio of urban and rural participants and distance from the clinic, were randomised to home-based or facility-based care by drawing sealed cards from a box. The trial was integrated into normal service delivery. All patients with WHO stage IV or late stage III disease or CD4-cell counts fewer than 200 cells per microL who started antiretroviral therapy between Feb 15, 2005, and Dec 19, 2006, were eligible, apart from those living on islands. Follow-up continued until Jan 31, 2009. The primary endpoint was virological failure, defined as RNA more than 500 copies per mL after 6 months of treatment. The margin of equivalence was 9% (equivalence limits 0.69-1.45). Analyses were by intention to treat and adjusted for baseline CD4-cell count and study stratum. This trial is registered at http://isrctn.org, number ISRCTN 17184129.\n 859 patients (22 clusters) were randomly assigned to home and 594 (22 clusters) to facility care. During the first year, 93 (11%) receiving home care and 66 (11%) receiving facility care died, 29 (3%) receiving home and 36 (6%) receiving facility care withdrew, and 8 (1%) receiving home and 9 (2%) receiving facility care were lost to follow-up. 117 of 729 (16%) in home care had virological failure versus 80 of 483 (17%) in facility care: rates per 100 person-years were 8.19 (95% CI 6.84-9.82) for home and 8.67 (6.96-10.79) for facility care (rate ratio [RR] 1.04, 0.78-1.40; equivalence shown). Two patients from each group were immediately lost to follow-up. Mortality rates were similar between groups (0.95 [0.71-1.28]). 97 of 857 (11%) patients in home and 75 of 592 (13%) in facility care were admitted at least once (0.91, 0.64-1.28).\n This home-based HIV-care strategy is as effective as is a clinic-based strategy, and therefore could enable improved and equitable access to HIV treatment, especially in areas with poor infrastructure and access to clinic care.\n Copyright 2009 Elsevier Ltd. All rights reserved.", "the objective of this study was to compare the outcomes of antiretroviral therapy (ART) between hospital and health center levels in Ethiopia.\n medical records of 1709 ART patients followed for 24 months at 2 hospitals and 3 health centers in the Oromia region of Ethiopia were reviewed. Noted outcomes of ART were currently alive and on treatment; lost to follow-up (LTFU); transferred out (TO); and died (D).\n of 1709 HIV-positive patients started on ART between September 2006 and February 2007, 1044 (61%) remained alive and were on treatment after 24-month follow-up. In all, 835 (57%) of ART patients at hospitals and 209 (83%) at health centers were retained in the program. Of those who were alive and receiving ART, 79% of patients at health centers and 72% at hospitals were clinically or immunologically improving. In addition, 331 (23%) patients at hospitals were LFTU as compared to 24 (10%) of patients at health centers (relative risk [RR] at 95% confidence interval [CI]: .358 [.231-.555]). While 11% was the mortality rate at hospitals, 5% of patients at health centers also died (RR at 95% CI: .360 [.192-.673]).\n antiretroviral therapy at health centers was associated with more favorable outcomes than at hospitals.", "To compare clinical, immunologic and virologic outcomes among stable HIV-positive patients down-referred to a nurse-managed primary healthcare clinic (PHC) for treatment maintenance to those who remained at a doctor-managed treatment-initiation site.\n We conducted a matched cohort analysis among stable HIV patients at the Themba Lethu Clinic in Johannesburg, South Africa. Eligible patients met the criteria for down-referral [undetectable viral load <10 months, antiretroviral therapy (ART) >11 months, CD4 cell count ≥200 cells/μl, stable weight and no opportunistic infections], regardless of whether they were down-referred to a PHC for treatment maintenance between February 2008 and January 2009. Patients were matched 1 : 3 (down-referred : treatment-initiation) using propensity scores.\n We calculated rates and hazard ratios (HRs) for the effect of down-referral on loss to follow-up (LTFU) and mortality and the relative risk of down-referral on viral rebound by 12 months of follow-up.\n Six hundred and ninety-three down-referred patients were matched to 2079 treatment-initiation patients. Two (0.3%) down-referred and 32 (1.5%) treatment-initiation patients died, 10 (1.4%) down-referred and 87 (4.2%) treatment-initiation patients were lost, and 22 (3.3%) down-referred and 100 (5.6%) treatment-initiation patients experienced viral rebound by 12 months of follow-up. After adjustment, patients down-referred were less likely to die [hazard ratio (HR) 0.2, 95% confidence interval (CI) 0.04-0.8], become LTFU (HR 0.3, 95% CI 0.2-0.6) or experience viral rebound (relative risk 0.6, 95% CI 0.4-0.9) than treatment-initiation patients during follow-up.\n The utilization of nurse-managed PHCs for treatment maintenance of stable patients could decrease the burden on specialized doctor-managed ART clinics. Patient outcomes for down-referred patients at PHCs appear equal, if not better, than those achieved at ART clinics among stable patients.", "To assess whether community-based care delivered by people living with HIV/AIDS (PLWAs) could replace clinic-based HIV care.\n Prospective cluster randomized controlled clinical trial.\n Villages surrounding 1 rural clinic in western Kenya.\n HIV-infected adults clinically stable on antiretroviral therapy (ART).\n The intervention group received monthly Personal Digital Assistant supported home assessments by PLWAs with clinic appointments every 3 months. The control group received standard of care monthly clinic visits.\n Viral load, CD4 count, Karnofsky score, stability of ART regimen, opportunistic infections, pregnancies, and number of clinic visits.\n After 1 year, there were no significant intervention-control differences with regard to detectable viral load, mean CD4 count, decline in Karnofsky score, change in ART regimen, new opportunistic infection, or pregnancy rate. Intervention patients made half as many clinic visits as did controls (P < 0.001).\n Community-based care by PLWAs resulted in similar clinical outcomes as usual care but with half the number of clinic visits. This pilot study suggests that task-shifting and mobile technologies can deliver safe and effective community-based care to PLWAs, expediting ART rollout and increasing access to treatment while expanding the capacity of health care institutions in resource-constrained environments.", "To compare the treatment outcomes and mortality in a rural community-based ART (CBART) program with a hospital-based ART program in the same district.\n The study design was a non-randomized cohort study consisting of 185 persons living with HIV (PLWHIV) in the CBART cohort and 200 PLWHIV in the hospital cohort. Eligibility for both cohorts was: being HIV-infected and eligible for ART, being treatment naïve, age 18 years or older, and being a resident of Rwimi sub-county. The intervention consisted of a community-based program which included weekly home visits to patients by trained volunteers who delivered antiretroviral drugs (ARVs), monitored and supported adherence to treatment, and identified and reported adverse reactions and other clinical symptoms. Outcome variables were compared to patients in a hospital-based cohort who received the standard care delivered to all other HIV patients in the hospital. The main outcome measures were HIV-1 RNA viral load (VL), CD4 cell count and mortality after six months of treatment.\n Successful ART treatment outcome as measured by virological suppression (VL<400 copies/ml) in the CBART cohort were similar to those in the hospital-based cohort (90.1% vs 89.3%, p=0.47). The median CD4 cell count increased significantly in both cohorts (community-based cohort 159 cells/microl vs 145 cells/microl in the hospital-based cohort). Mortality was not significantly different in both cohorts (community-based cohort 11.9%, hospital-based cohort 9.0%).\n The findings show that outcomes of a CBART intervention in a rural area compare favorably to outcomes of hospital-based care. If the study results are sustainable over a longer time period, this model could be considered for ART roll-out to impoverished rural/remote populations in Uganda and elsewhere." ]

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[ "A randomized comparison of Worksite-sponsored smoking cessation programs.", "A comprehensive worksite cancer prevention intervention: behavior change results from a randomized controlled trial (United States).", "Long-term smoking intervention at the worksite: effects of quit-smoking groups and an \"enriched milieu\" on smoking cessation in adult white-collar employees.", "The Working Healthy Project: a worksite health-promotion trial targeting physical activity, diet, and smoking.", "Tools for health: the efficacy of a tailored intervention targeted for construction laborers.", "Combined use of nicotine patch and gum in smoking cessation: a placebo-controlled clinical trial.", "Promoting smoking cessation at the workplace. Results of a randomized controlled intervention study.", "Long-term effectiveness of two Dutch work site smoking cessation programs.", "[Randomized controlled trial for smoking cessation among city office employees].", "Maintaining abstinence from cigarette smoking: effectiveness of group counselling and factors predicting outcome.", "Effects of a tailored health promotion program for female blue-collar workers: health works for women.", "Hypnosis and behavioral treatment in a worksite smoking cessation program.", "Evaluation of a worksite-controlled smoking program.", "Payroll contracting for smoking cessation: a worksite pilot study.", "Programming social support for smoking modification: an extension and replication.", "The impact of increasing intensity of health promotion intervention on risk reduction.", "Work site-based cancer prevention: primary results from the Working Well Trial.", "The effects of a health promotion-health protection intervention on behavior change: the WellWorks Study.", "Smoking cessation at the workplace. Results of a randomised controlled intervention study. Worksite physicians from the AIREL group.", "One year effectiveness of an individualised smoking cessation intervention at the workplace: a randomised controlled trial.", "Computerized smoking cessation program for the worksite: treatment outcome and feasibility.", "Worksite wellness programs: incremental comparison of screening and referral alone, health education, follow-up counseling, and plant organization.", "Effectiveness of a low-intensity intra-worksite intervention on smoking cessation in Japanese employees: a three-year intervention trial.", "The Paris Cardiovascular Risk Factor Prevention Trial. Effects of two years of intervention in a population of young men.", "The effects of contingent payment and frequent workplace monitoring on smoking abstinence.", "The Belgian heart disease prevention project: changes in smoking habits after two years of intervention.", "Randomized controlled trial of relapse prevention and a standard behavioral intervention with adult smokers.", "A double blind study of 2 mg versus 4 mg nicotine-gum in an industrial setting.", "Work-site cardiovascular risk reduction: a randomized trial of health risk assessment, education, counseling, and incentives.", "Randomized trial of brief individual treatment for smoking using nicotine chewing gum in a workplace setting.", "Results of a year-long incentives-based worksite smoking-cessation program.", "Effectiveness of smoking-cessation intervention in all of the smokers at a worksite in Japan.", "The SUCCESS project: the effect of program format and incentives on participation and cessation in worksite smoking cessation programs.", "The effectiveness of a worksite self-help smoking cessation program: a randomized trial.", "Take heart: results from the initial phase of a work-site wellness program.", "Smoking intervention in the workplace using videotapes and nicotine chewing gum.", "A worksite smoking cessation intervention involving the media and incentives.", "Effects of physician counseling on the smoking behavior of asbestos-exposed workers.", "The effectiveness of an education program on stages of smoking behavior for workers at a factory in Turkey.", "[The effect of smoking cessation counseling at health checkup].", "Co-worker social support in a worksite smoking control program.", "A comprehensive worksite smoking control, discouragement, and cessation program." ]

[ "This worksite study assesses the relative effectiveness of three smoking cessation programs. Computerized medical files indicated that 29% of 13,171 employees were current smokers. Of smokers responding to a worksite-wide survey, 79% indicated interest in a smoking cessation program; 402 smokers agreed to participate and were randomly allocated, within their preference for a group or self-help approach, to the three different programs. Overall, 11% of smokers participated, an excellent rate for a large worksite. Participants were followed for 12 months (91% follow-up). Smokers in the group preference had better short-term results than did those following the self-help approach. The Multiple Component Program had 61% who quit, the Relapse Prevention Program had 37%, and the American Cancer Society Quitter's Guide had 12%. Long-term quit rates ranged from 16% to 26%; all groups exceeded the usual spontaneous quit rate of 5%.", "Workplace cancer prevention initiatives have been least successful with blue-collar workers. This study assess whether an intervention integrating health promotion with occupational health and safety results in significant and meaningful increases in smoking cessation and consumption of fruits and vegetables, compared to a standard health promotion intervention, for workers overall and for blue-collar workers in particular.\n A randomized controlled design was used, with 15 manufacturing worksites assigned to a health promotion (HP) or a health promotion plus occupational health and safety intervention (HP/OHS), and compared from baseline (1997) to final (1999). The response rates to the survey were 80% at baseline (n = 9019) and 65% at final (n = 7327). Both groups targeted smoking and diet; the HP/OHS condition additionally incorporated reduction of occupational exposures.\n Smoking quit rates among blue-collar workers in the HP/OHS condition more than doubled relative to those in the HP condition (OR = 2.13, p = 0.04), and were comparable to quit rates of white-collar workers. No statistically significant differences between groups were found for mean changes in fruits and vegetables.\n Integration of occupational health and safety and health promotion may be an essential means of enhancing the effectiveness of worksite tobacco control initiatives with blue-collar workers.", "Maximizing the potential of worksites for smoking intervention remains elusive. We hypothesized that long-term effectiveness of group intervention would be enhanced when offered within an \"enriched milieu\" (full program) compared with relative isolation (group only). The data failed to support the hypothesis. Although sustained abstinence rates were higher at full-program sites (50%) than at group-only sites (44%), the difference did not achieve statistical significance. Initial (35% vs. 47%) and 12-month (18% vs. 22%) quit rates at full-program and group-only sites also failed to demonstrate the \"benefit\" of the \"enriched milieu.\"", "Worksites are a key channel for delivery of interventions designed to reduce chronic disease among adult populations. Although some evaluations of worksite physical-activity interventions have been conducted, to date very few randomized trials of worksite health promotion have included the goal of increasing physical-activity levels as part of a comprehensive multiple risk factor approach to worksite health promotion. This article presents the results regarding behavior change found among the cohort of 2055 individuals who completed three health-behavior assessments as part of their worksites' participation in The Working Healthy Project (WHP), a multiple risk factor intervention implemented in 26 manufacturing worksites. In this study, a randomized matched-pair design was used. Fifty-one percent (n = 2,761) of the employees who completed the baseline assessment also completed the interim survey. Eighty-three percent of those who completed the interim assessment also completed the final survey. The WHP intervention targeted smoking, nutrition, and physical activity. At baseline, 38% of the sample reported engaging in regular exercise, and subjects reported consuming an average of 2.7 servings of fruits and vegetables per day, 7.9 grams of fiber per 1000 kilocalories, and 35.4% calories from fat per day; 28% of the sample were smokers. By the time of both the interim (intervention midpoint) and final (end of intervention) assessments, participants in the intervention condition had significantly increased their exercise behavior, compared with the control condition. There was also increased consumption of fruits and vegetables and fiber in the intervention condition by the time of the final assessment, compared with the control condition. No differences by condition were found with regard to percentage of calories from fat consumed or smoking cessation. These results suggest that among a cohort of participants in a worksite health promotion study, there were significant health behavior changes across two risk factors over time. These data suggest that further investigation of multiple risk factor worksite health promotion is warranted, particularly with a focus on ways to increase participation in these programs and to diffuse intervention effects throughout the entire workforce.", "Novel approaches to worksite health promotion are needed for high-risk workers who change job sites frequently, and thus may have limited access to worksite health promotion efforts. The objective of this study was to test a behavioral intervention among construction laborers.\n Using a randomized-controlled design, we tested the efficacy of a tailored telephone-delivered and mailed intervention to promote smoking cessation and increased fruit and vegetable consumption (n = 582).\n At baseline, 40% of control group participants and 45% of intervention group participants reported using any tobacco in the last seven days. At final, 8% of baseline cigarette smokers in the control group had quit, compared to 19% in the intervention group (p = 0.03). In both groups, the mean consumption of fruits and vegetables at baseline was over five servings per day. At final, the intervention group had increased consumption by approximately one and one-half servings, compared to a slight decrease in consumption in the control group (p < 0.001).\n A tailored intervention can be efficacious in promoting tobacco use cessation and increased fruit and vegetable consumption among construction laborers, a high-risk, mobile workforce.", "Smoking is considered as an addiction to nicotine for most subjects consuming 10 cigarettes or more per day. Hence, nicotine replacement therapy by way of gum, patch, or spray has been advocated. The rationale of this study is to evaluate the possible beneficial effects of adding nicotine gum to the routine of subjects using the nicotine patch. The effect of the nicotine patch against the placebo, both groups receiving placebo nicotine gum, has also been assessed.\n Healthy subjects (374) were randomized at their work-setting in a 1-year double-blind placebo-controlled trial: 149 subjects to active nicotine patch + active gum (group 1), 150 to active nicotine patch + placebo gum (group 2), and 75 to placebo patch + gum (group 3). Treatment duration was 12 weeks with a 16-hr transdermal patch of 15 mg, followed by a 6 + 6-weeks weaning period on respectively 10 and 5 mg patches. Gum use was not restricted during the first 6 months, with recommendations to use at least four pieces a day. A strict definition of smoking abstinence was used in this study, which did not allow smoking any cigarette after Week 1. Nonsmoking status at each visit, as reported by the subjects, was verified by CO below 10 ppm in expired air.\n Abstinence rates in group 1 against group 2 were 34.2 and 22.7% (P = 0.027) at 12 weeks, 27.5 and 15.3% (P = 0.010) at 24 weeks, and 18.1 and 12.7% (P = 0.191) at 52 weeks. In group 3, abstinence rates were 17.3, 14.7, and 13.3% respectively at 12, 24, and 52 weeks. Using logistic regression with adjustment for six baseline covariates, odds ratios for abstinence (with 95% CI) were computed. For group 1/group 2, OR at 12, 24, and 52 weeks were 1.72 (1.03-2.94) (P = 0.039), 2.04 (1.14-3.57) (P = 0.018), and 1.47 (0.76-2.76) (P = 0.125). No significant differences in OR were observed when comparing groups 2 and 3. Time to relapse is significantly longer in group 1 as compared to that of group 2 (P = 0.041), whereas no significant differences between groups 2 and 3 were observed. No significant differences between the three groups in systemic and local adverse drug events were observed.\n Adding active gum use to active patch use in subjects smoking 10 cigarettes or more a day increased abstinence rates, which are statistically significant up to 24 weeks.", "This paper presents results from a preliminary short-term work-site intervention study aimed at smoking cessation. The 3-month intervention included consultation for employers on the adoption of a nonsmoking policy, training for nonsmokers to provide assistance to smokers attempting to quit, and cessation classes for smokers. Eight work sites from Bloomington, Minnesota were recruited to the study and randomly assigned to an intervention or comparison condition after a baseline survey of all employees. To assess the effect of the intervention, smokers were surveyed 1 and 6 months after the intervention was completed. At the 1-month follow-up, the overall quit rate in the intervention group was 12% compared to 5% in the control group (P < .05). At the 6-month follow-up, 12% of smokers in the intervention group reported quitting, compared to 9% in the control group (P < .05). Co-worker support for quitting was higher in the intervention group compared to the comparison group. Cessation was highest overall among smokers whose co-workers frequently asked them not to smoke and among those who worked with a high proportion of nonsmokers. These results indicate that a short-term, multifaceted smoking cessation program implemented in work sites can affect smoking cessation rates as well as the work-site norms about smoking.", "This article reports on one of the few experimental studies in Europe to examine work site smoking cessation. The study examined whether a comprehensive intervention (self-help manuals, group courses, a mass media campaign, smoking policies, and a second-year program) is more effective than a minimal intervention (self-help manuals only). Eight work sites participated in the study. The effect of treatment on smoking cessation depended on nicotine dependency levels: Heavy smokers had more success with the comprehensive smoking cessation intervention than with the minimal intervention (with respect to both 14-month quit rate and 6-month prolonged abstinence). For heavy smokers, exposure to mass media exhibitions or to group courses had a beneficial effect on prolonged abstinence. Comprehensive programs may be most appropriate in Dutch work sites with large proportions of heavily addicted smokers.", "To evaluate the effect of a smoking cessation program by health professionals, a randomized intervention study was carried out in the Omihachiman city office in 1993. Participants (n = 53), volunteers from current smokers in the city office, were randomly divided into intervention and control groups. The intervention group received intensive education for five months (i.e., the effect of smoking on health, the beneficial aspects of quitting smoking, how to stop smoking and how to deal with the withdrawal symptoms). Group lectures (two times) and individual counseling (three times) were used for health education. After five months, the control group was also given the same advice on smoking cessation. Comparison of smoking cessation rates between the two groups was performed at the end of the intervention period. Follow-up of all participants occurred at six and 12 months post intervention. After the five months of intervention, smoking cessation rate in the intervention group (19.2%) tended to be higher than that in the control group (7.4%), but was not significant (chi 2 = 1.62). Over all smoking cessation rates of all participants (n = 53) at the end of the 10 month intervention was 32.1% and at six months and 1 year after the end of the 10 month intervention were 24.5% and 13.2%, respectively. Comparison of participants who successfully stopped smoking and those who did not, it was revealed that younger age, lower expired air CO concentration (p < 0.01), and attitude for smoking cessation at the beginning were significantly related to smoking cessation. In our study, after five months, smoking cessation rate in the intervention group was about two times that of the control group, although the effectiveness of our smoking cessation program could not be validated due to small sample size. Taking into account the rate of smoking cessation after one year, We believe that programs by health professionals are effective for smoking cessation.", "The aim of the study was to assess the effectiveness of worksite group counselling interventions designed to prevent smoking relapse after abstinence has been achieved following 3 months therapy using group support and/or transdermal nicotine replacement therapy. After 3 months, abstinent subjects were randomly allocated either to a counselling group led by professional psychologists (PG), to a counselling group led by former smokers (SG) or to no intervention group (NG). The 3 and 12 months abstinence were defined, respectively, as a sustained smoking cessation during the last month, and the last 9 months. Complete abstinence was confirmed by expired carbon monoxide and by urine cotinine concentrations. The abstinence rate at 3 months was 35.1%. After 12 months abstinence rates were not statistically different in the PG, the SG and the NG (respectively 57.8, 53.4 and 49.6% of those randomised). In multivariate analyzes, baseline variables associated with 12 months abstinence were non-smoking family, gender (male), lower daily intake of nicotine and better psychological adjustment. Mean weight gain at 3 months in abstinent versus relapsed subjects, was respectively, 4.1 and 2.4 kg. Baseline variables associated with weight gain at 3 months were higher Fagerström score, gender (male) and professional status (blue collar worker). Group support after abstinence has been achieved did not significantly improve the abstinence. This study shows the difficulty of preventing smoking relapse with monthly group counselling. The results indicate the need to investigate further specific programmes focusing on factors such as gender, family, nicotine dependence, psychological and weight concerns/issues which may precipitate relapse.", "This study assessed the effects of the Health Works for Women (HWW) intervention on improving multiple behaviors including nutrition and physical activity among rural female blue-collar employees in North Carolina.\n Nine small to mid-size workplaces were randomly assigned to either intervention or delayed intervention conditions. After a baseline survey, an intervention consisting of two computer-tailored magazines and a natural helpers program was conducted over 18 months. Delayed worksites received one tailored magazine. Approximately 77 and 76% of baseline respondents completed follow-up surveys at 6 and 18 months, respectively, and 538 women (63%) completed all three surveys.\n At the 18-month follow-up, the intervention group had increased fruit and vegetable consumption by 0.7 daily servings compared to no change in the delayed group (P < 0.05). Significant differences in fat intake were observed at 6 months (P < 0.05) but not at 18 months. The intervention group also demonstrated improvements in strengthening and flexibility exercise compared to the delayed group. The rates of smoking cessation and cancer screening did not differ between study groups.\n The HWW project was a successful model for achieving certain health behavior changes among blue-collar women.\n (C)2002 American Health Foundation and Elsevier Science (USA).", "In the initial study, 48 subjects of the total (N = 63) ultimately used, were assigned to one of three treatments: four hypnotic sessions with a booster, two hypnotic sessions, or two hypnotic and two behavioral sessions with a booster. A follow-up group was later recruited composed of 15 subjects who received four hypnotic sessions and a booster session with less time between sessions. The results indicated no difference in smoking cessation 6 months after treatment regardless of the frequency, length between sessions, or addition of behavioral methods. Successful subjects were more educated, less able to utilize their imagination, and had fewer smokers at home.", "nan", "Twenty-one men and 38 women participated in a worksite smoking cessation/smoking reduction program that combined financial contracts, organized through payroll deduction, and biweekly group treatment sessions. At the end of the program the smoking cessation rate was 51%, validated by expired air carbon monoxide. Six months later the validated cessation rate was 12%. We conclude that payroll incentives may be effective in helping workers quit smoking and offer suggestions for ways to promote better maintenance of this important behavior change.", "In an extension and replication of previous work on social support in worksite smoking programs, 29 employees were assigned to either a basic smoking control program or to a basic treatment plus significant other support condition. Within a multiple baseline across behaviors design, all subjects received a 6 week treatment program that focused on achieving sequential reductions in nicotine content of brand smoked, number of cigarettes smoked per day, and percent of the cigarette smoked. Both treatment conditions were equally successful in producing abstinence (verified by biochemical analyses) and in producing reductions in smoking behavior among nonabstinent subjects at both posttest and 6-month follow-up assessments. In contrast to previous research with this program, there was considerable relapse in both conditions by follow-up. Consistent with previous findings, supportive social interactions were not related to treatment outcome, but the level of negative (nonsupportive) social interactions was inversely correlated with treatment success. Implications of these findings and directions for future research are discussed.", "The HealthWise Stepped Intervention Study (1988-1990) at Pacific Gas and Electric was conducted to evaluate how a health promotion program affects behavior change and whether increasing levels of preventive interventions improve health status. The basic intervention components consisted of health risk assessment and health newsletter (Levels 1, 2, 3, and 4). Additional interventions were health resource center and self-care books (Levels 2, 3, and 4), behavioral change workshops and Division Healthwise team (Levels 3 and 4), and case management and environmental policy (Level 4). The study employed a quasi-experimental design with nonequivalent control groups. The overall risk status has significantly improved at all four intervention levels. The comparison across the four intervention levels found that Level 4, combining environmental policy with \"high risk\" targeting, showed the most impressive performance. Participants in Level 4 consistently showed significantly greater improvement in life-style factors, and their overall risk status also showed the greatest improvement.", "This paper presents the behavioral results of the Working Well Trial, the largest US work site cancer prevention and control trial to date.\n The Working Well Trial used a randomized, matched-pair evaluation design, with the work site as the unit of assignment and analysis. The study was conducted in 111 work sites (n = 28,000 workers). The effects of the intervention were evaluated by comparing changes in intervention and control work sites, as measured in cross-sectional surveys at baseline and follow-up. The 2-year intervention targeted both individuals and the work-site environment.\n There occurred a net reduction in the percentage of energy obtained from fat consumption of 0.37 percentage points (P = .033), a net increase in fiber densities of 0.13 g/1000 kcal (P = .056), and an average increase in fruit and vegetable intake of 0.18 servings per day (P = .0001). Changes in tobacco use were in the desired direction but were not significant.\n Significant but small differences were observed for nutrition. Positive trends, but no significant results, were observed in trial-wide smoking outcomes. The observed net differences were small owing to the substantial secular changes in target behaviors.", "This study assessed the effects of a 2-year integrated health promotion-health protection work-site intervention on changes in dietary habits and cigarette smoking.\n A randomized, controlled intervention study used the work site as the unit of intervention and analysis; it included 24 predominantly manufacturing work sites in Massachusetts (250-2500 workers per site). Behaviors were assessed in self-administered surveys (n = 2386; completion rates = 61% at baseline, 62% at final). Three key intervention elements targeted health behavior change: (1) joint worker-management participation in program planning and implementation, (2) consultation with management on work-site environmental changes, and (3) health education programs.\n Significant differences between intervention and control work sites included reductions in the percentage of calories consumed as fat (2.3% vs 1.5% kcal) and increases in servings of fruit and vegetables (10% vs 4% increase). The intervention had a significant effect on fiber consumption among skilled and unskilled laborers. No significant effects were observed for smoking cessation.\n Although the size of the effects of this intervention are modest, on a populationwide basis effects of this size could have a large impact on cancer-related and coronary heart disease end points.", "To compare the effects of a worksite intervention by the occupational physician offering simple advice of smoking cessation with a more active strategy of advice including a \"quit date\" and extra support.\n Employees of an electrical and gas company seen at the annual visit by their occupational physicians. CRITERIA END POINTS: Smoking point prevalence defined as the percentage of smokers who were non-smokers at one year. Secondary criteria were the percentage of smokers who stopped smoking for more than six months and the difference in prevalence of smoking in both groups.\n Randomised controlled trial. The unit of randomisation was the work site physician and a random sample of the employees of whom he or she was in charge. The length of the follow up was one year. Each of 30 work site physicians included in the study 100 to 150 employees.\n Among 504 subjects classified as smokers at baseline receiving simple advice (group A) and 591 the more active programme (group B), 68 (13.5%) in group A and 109 (18. 4%) were non-smokers one year later (p=0.03; p=0.01 taking the occupational physician as the statistical unit and using a non-parametric test). Twenty three subjects (4.6%) in group A and 36 (6.1%) in group B (p=0.26) declared abstinence of six months or more. Among non-smokers at baseline, 3.4% in both groups were smokers after one year follow up. The prevalence of smokers did not differ significantly at baseline (32.9% and 32.4%, p=0.75). After the intervention the prevalence of smoking was 30.8% in group A and 28. 7% in group B (p=0.19). An increase of the mean symptoms score for depression in those who quit was observed during this period.\n A simple cessation intervention strategy during a mandatory annual examination, targeting a population of smokers independently of their motivation to stop smoking or their health status, showed a 36% relative increase of the proportion of smokers who quit smoking as compared with what can be achieved through simple advice.", "To assess the effectiveness of a smoking cessation intervention at the workplace. The intervention was adapted to smokers' tobacco dependence, and included minimal structured counselling at the first visit (5-8 minutes), nicotine patches for three months, and three sessions of counselling for reinforcement of abstinence (2-3 minutes) over a three month period.\n Open randomised trial with two groups: the intervention group, and the control group which was subjected to standard clinical practice, consisting of short (30 seconds to one minute) sporadic sessions of unstructured medical antismoking advice. The trial was carried out among 217 smokers of both sexes, aged 20-63 years, motivated to quit smoking and without contraindications for nicotine patches, who were employees at a public transport company and at two worksites of an electric company. The main outcome measure was self reported tobacco abstinence confirmed by carbon monoxide in expired air </=10 ppm. Analysis was performed according to intention-to-treat.\n The rate of continuous abstinence at 12 months was 20.2% for the intervention versus 8.7% for the control group (OR: 2.58; 95% CI: 1.13 to 5.90; p = 0.025). In subgroup analyses, effectiveness of the intervention did not vary substantially with age, tobacco dependence, number of cigarettes smoked per day, number of years of tobacco consumption, degree of desire to quit smoking, time spent with smokers, subjective health, and presence of tobacco related symptoms. Weight gain at 12 months was similar for both groups (1.69 kg in the intervention v 2.01 kg in the control group; p = 0.21).\n A simple and easily generalisable intervention at the workplace is effective to achieve long term smoking cessation. In a setting similar to ours, nine subjects would have to be treated for three months for one to achieve continuous abstinence for 12 months.", "This study demonstrated the effectiveness of a computer-delivered smoking cessation program for the worksite. 58 VA Medical Center employees were randomly assigned to a computer group (computerized nicotine fading and stop-smoking contest) or a contest-only group. In comparison with the contest-only group, the computer group had nonsignificantly higher abstinence rates across follow-up, had marginally lower CO levels at the 3- and 6-month follow-ups, and smoked cigarettes with lower nicotine levels at the 10-day and 6-month follow-ups.", "Worksite wellness programs vary considerably in their design. This study tested four models to compare effectiveness at controlling high blood pressure, obesity, and cigarette smoking.\n Baseline screening was conducted in four manufacturing plants. Site 1 offered screening only, with referral recommendations for those found to have CVD risks. Site 2 also provided health education information and classes. Site 3 added routine follow-up counseling and a menu of intervention types, and Site 4 added social organization within the plant. Random samples of 400 to 500 employees were rescreened at the end of three years.\n Major improvements in risk levels were found with the addition of routine follow-up counseling and a menu of interventions (Sites 3 and 4, compared with Sites 1 and 2). More hypertensives entered treatment and showed greater reductions in blood pressure. Participation in worksite weight loss and smoking cessation programs was significantly increased, and those who participated showed significantly better maintenance of improvements where follow-up was provided.\n The program models that offered short-term interventions promoted through local media suffered in comparison with models that included personal outreach to people at risk, a variety of health improvement intervention modalities, and ongoing follow-up counseling to help people make decisions and sustain health improvements.", "To test the effectiveness of a low-intensity intervention program for smoking cessation targeting the worksite environment in employees who had a low readiness to quit, we conducted an intervention trial at six intervention and six control worksites in Japan. A total of 2,307 smokers at baseline who remained at their worksite throughout the three-year study period were analyzed (1,017 in intervention and 1,290 in control groups). The multi-component program at the worksites consisted of (1) presenting information on the harms of tobacco smoking and the benefits of cessation by posters, websites, and newsletters; (2) smoking cessation campaigns for smokers; (3) advice on designation of smoking areas; and (4) periodic site-visits of the designated smoking areas by an expert researcher. At baseline, the intervention and control groups each had high prevalence of immotive or precontemplation, that reflected low readiness to quit (71.5% and 73.2%, respectively). The smoking cessation rate, as not having smoked for the preceding six months or longer, assessed at 36 months after the baseline survey by a self-administered questionnaire was significantly higher in the intervention group than the control group (12.1%, vs. 9.4%, p=0.021). The intervention program still had a significant effect on the smoking cessation rate after multiple logistic regression analysis adjusted for sex, age, type of occupation, age of starting smoking, quit attempts in the past, number of cigarettes per day, and readiness to quit (odds ratio: 1.38, 95% confidence interval: 1.05-1.81, p=0.02). The cost per additional quitter due to the intervention was calculated to be Yen 70,080. These findings indicate that this program is effective and can be implemented in similar workplaces where the prevalence of smoking is high and smokers' readiness to cease smoking is low.", "The Paris Cardiovascular Risk Factor Prevention Trial was designed to determine whether individualised intervention could induce a reduction in the coronary risk factor levels in young men. Three thousand three hundred and thirty-six men aged 25 to 35, working in the 160 sections of a large Parisian administration, were examined. The section were randomly allocated to a control and an intervention group. Advice concerning diet, cigarette smoking, and physical activity was provided repeatedly to the subjects in the intervention group. Two years after the first intervention, the first 1292 subjects who entered the study, whether from the intervention or the control group, were recalled; 86% of the intervention group and 84% of the control group responded. The changes in weight, blood pressure, and cigarette smoking in the intervention group, corrected for changes in the control group, were respectively -0.4 kg (p = 0.06), -1.4 mm Hg (p less than 0.05), and -1.2 cigarettes (p less than 0.01). There was no difference between the two groups in serum cholesterol change. Most of these results concerning young men are in agreement with recently reported results of community intervention programmes in middle-aged men.", "This study examined the relative contribution of contingent payment and worksite CO monitoring to the long-term maintenance of smoking abstinence. Forty-seven hospital employees who had abstained from smoking for five days (confirmed by CO analysis) were randomly assigned to one of three follow-up groups: (a) contingent payment/frequent monitoring (n = 17); (b) noncontingent payment/frequent monitoring (n = 16); or (c) non-contingent payment/infrequent monitoring (n = 14). Contingent payment combined with frequent CO monitoring delayed but did not ultimately prevent subjects relapse to smoking by the end of the six month follow-up. Contingent subjects maintained CO values less than or equal to 11 ppm significantly longer than did either the Non-contingent or the Control subjects (p = .03). CO monitoring alone had no effect on abstinence outcomes; both Noncontingent and Control subjects showed high rates of early relapse.", "nan", "A previously evaluated behavioral intervention (SB) was modified to focus on relapse prevention (RP) in order to improve adult smokers' ability to cope with high-risk situations and maintain abstinence. Treatment-seeking smokers (N=79) working at four mid-sized businesses attended either an SB (n=38) or an RP intervention (n=41). Both interventions consisted of 6 and 90-min sessions over 8 weeks and included nicotine replacement therapy. Immediately following the interventions, 42.1% of the SB group and 41.5% of the RP group were abstinent (p=.95). The one-year point-prevalence abstinence rates were 28.9% in the SB group and 17.1% in the RP group (p=.21). As there were no significant group differences on abstinence at follow-up, the RP intervention was not found to be more efficacious than a standard behavioral intervention among treatment-seeking adult smokers. Motivation, on the other hand, was a significant predictor of short- and long-term abstinence.", "In a double blind randomised trial to aid smoking cessation a 2 mg nicotine gum (n = 101) was compared with a 4 mg gum (n = 98), in smokers of at least 15 cigarettes/day. The trial involved blue and white collar workers and took place at their working place (industrial setting). Intervention during the one year follow-up period was minimal. At 3 months 36.2% of the 2 mg nicotine gum group reported to have stopped smoking, against 44.8% in the 4 mg group (non-significant difference). At one year in the 2 and 4 mg groups respectively 22.3 and 32.2% reported smoking abstinence (non significant difference). However in a sub-group with a higher nicotine-dependence score, only 18.5% were abstainers at one year in the 2 mg nicotine gum group against 32.9% in the 4 mg nicotine gum, which is a significant difference at the p = 0.05 level. This is however a post-hoc finding and should be taken with caution.", "This study reports an efficacy trial of four work-site health promotion programs. It was predicted that strategies making use of behavioral counseling would produce a greater reduction in cardiovascular disease risk factors than screening and educational strategies.\n Twenty-eight work sites were randomly allocated to a health risk assessment, risk factor education, behavioral counseling, or behavioral counseling plus incentives intervention. Participants were assessed before the intervention and at 3, 6, and 12 months.\n Compared with the average of the health risk assessment and risk factor education conditions, there were significantly higher validated continuous smoking cessation rates and smaller increases in body mass index and estimated percentage of body fat in the two behavioral counseling conditions. The behavioral counseling condition was associated with a greater reduction in mean blood pressure than was the behavioral counseling plus incentives condition. On average among all groups, there was a short-term increase in aerobic capacity followed by a return to baseline levels.\n Work-site interventions that use behavioral approaches can produce lasting changes in some cardiovascular risk factors and, if implemented routinely, can have a significant public health impact.", "In a controlled trial of brief treatment for smoking using nicotine chewing gum in a workplace setting, 270 of 334 cigarette smokers who expressed interest were invited to take part in the program, which consisted of two individual consultations; 172 attended. The remaining 64 smokers constituted a no-intervention control group. Using a criterion of sustained one-year abstinence with biochemical validation, success rates were 12 per cent among participants, 1 per cent among those who were invited but did not attend, and 2 per cent in the control group.", "This study evaluated the impact of a year-long incentives-based worksite smoking-cessation program. Nineteen moderate-sized worksites, employing a total of approximately 1100 smokers, were randomized to Incentive or No Incentive conditions. All identified smokers in the worksite were considered as subjects, whether or not they participated in the intervention. Analyses were conducted at both the worksite and individual level, and using both self-reported and biochemically validated cessation as endpoints. The incentive program did not significantly improve cessation rates at either the 1-year or 2-year follow-up assessments. We conclude that more broadly focused interventions that also address worksite smoking policies, skills training, and cessation resources, or programs that target additional risk factors are needed to substantially enhance quit rates.", "In Japan, the prevalence of smoking among males and females was 56.1% and 14.2%, respectively, in 1997. Male smoking prevalence was exceedingly high as compared to those in other industrialized countries. We conducted a randomized controlled intervention study on smoking cessation for all smokers in a worksite regardless of their willingness to quit smoking. All of the male smokers in a radiator manufacturing factory (n=263) were randomly allocated to an intervention group (n=132) or a control group (n=131). Subjects in the intervention group received individual counseling by a doctor, and those who signed a Smoking Cessation Declaration underwent a five-month intervention. Subjects in the control group received equivalent delayed intervention for four months. The cessation rate after the original intervention was 12.9% (17/132) and 3.1% (4/131) in the intervention and control groups, respectively (p=0.003). Among those who once succeeded in quitting, 48.6% (18/37) maintained cessation at the long-term survey. Overall, the cessation rate was 8.4% (22/263) and the prevalence of smoking among males significantly decreased from 62.9 to 56.7% (p=0.038). As a conclusion, intervention in all smokers at a worksite regardless of their willingness to quit is effective and impacts the overall smoking rate.", "This study examined the effect of program format and incentives on participation and cessation in worksite smoking cessation programs.\n Twenty-four worksites were randomized to 6 conditions that differed in cessation program format and the use of incentives. Programs were offered for 18 months in each worksite. A total of 2402 cigarette smokers identified at baseline were surveyed 12 and 24 months later to assess participation in programs and cessation.\n A total of 407 (16.9%) of the smoker cohort registered for programs; on the 12- and 24-month surveys, 15.4% and 19.4% of the cohort, respectively, reported that they had not smoked in the previous 7 days. Registration for programs in incentive sites was almost double that of no-incentive sites (22.4% vs 11.9%), but increased registration did not translate into significantly greater cessation rates. Program type did not affect registration or cessation rates.\n Although incentives increase rates of registration in worksite smoking cessation programs, they do not appear to increase cessation rates. Phone counseling seems to be at least as effective as group programs for promoting smoking cessation in worksites.", "A 2 x 2 randomized, factorial pretest/posttest group design was used to evaluate the effectiveness of self-help smoking cessation methods at the worksite. The study investigated the effect of a multicomponent health education and skill intervention versus the effect of a monetary incentive to the employee for quitting. All employees received, in addition, a standardized self-help smoking cessation manual and maintenance manual. Following agreement to participate and a baseline smoking history, all participants were followed for 6 weeks, 6 months, and 12 months. Saliva was obtained for thiocyanate (SCN) analysis of smoking status. Of the estimated 2000 smokers at the site, 387 smokers were recruited. Employees were randomly assigned to one of four groups. Results of this random trial indicate that those employees receiving a multicomponent program were most successful in quitting and remaining abstinent. The monetary incentive appears to have no effect on quit rate.", "The purpose of this study was to evaluate the short-term effects of a low-intensity work-site heart disease risk reduction program using a matched pair design with work site as the unit of analysis.\n Twenty-six heterogeneous work sites with between 125 and 750 employees were matched on key organization characteristics and then randomly assigned to early or delayed intervention conditions. Early intervention consisted of an 18-month multifaceted program that featured an employee steering committee and a menu approach to conducting key intervention activities tailored to each site.\n Cross-sectional and cohort analyses produced consistent results. At the conclusion of the intervention, early and delayed intervention conditions did not differ on changes in smoking rates, dietary intake, or cholesterol levels. There was considerable variability in outcomes among work sites within each condition.\n Despite documented implementation of key intervention activities and organization-level changes in terms of perceived support for health promotion, this intervention did not produce short-term improvements beyond secular trends observed in control work sites. Research is needed to understand determinants of variability between work sites.", "This article reports a series of randomized controlled studies in four companies in the United Kingdom which were designed to evaluate minimal smoking intervention programs based on the use of motivational videotapes or nicotine chewing gum. In the videotape studies, groups of smokers (N = 603) were randomly assigned to watch one of several different videotapes. They were followed-up, along with nonparticipants (N = 1,015), at 3 months and again at 1 year, and a biochemical validation of abstinence was performed. There were significant differences between the videotape conditions with regard to attitudes assessed immediately after exposure (intention and fear) and the proportion of smokers who tried to stop, but there were no significant differences in cessation, even in the short term. Using a strict definition of abstinence, long-term abstinence rates were under 10% in all four studies. In one company, we also investigated the effect of offering brief individual treatment based on nicotine chewing gum to a randomly chosen 50% sample of the videotape group (N = 161) still smoking at the 3-month follow-up. The treatment course was administered by occupational health nurses and consisted of four short consultations over a 12-week period. The results were encouraging: 16% of those who took the offer stopped during treatment and were still abstinent 1 year after the start of treatment compared with only 2% of the randomized no-intervention control group and 0% of those who were invited but did not attend.", "This study evaluated an attempt at 38 workplaces to help employees stop or reduce their levels of smoking. In past research, worksite support groups, in combination with a media smoking cessation program and self-help manuals, were found to be effective in helping employees quit smoking. Unfortunately, recidivism was found at the follow-up evaluations. The present study replicated the results of the previous worksite smoking cessation program with support groups, a television intervention, and self-help manuals. At this postpoint, 42% of employees provided groups plus incentives were abstinent compared to only 15% who were only provided self-help materials. An important difference in this study was that there were also monthly follow-up support groups and incentives. Work settings can be a source of stress and conflict, which can precipitate relapse. At a 12-month follow-up, 26% of those participants who were provided support and incentives were abstinent compared to 16% who were only provided the self-help materials.", "Physician antismoking advice has been shown to increase smoking cessation, particularly among patients who have medical problems or perceive themselves to be at risk. The present study tested three hypotheses: (a) providing 3 to 5 min of behavioral counseling regarding a cessation strategy would be more effective than simply warning the smoker to quit smoking; (b) smokers with abnormal pulmonary function would be more likely to comply with medical advice than would smokers with normal pulmonary function; and (c) that smokers with abnormal pulmonary function who receive behavioral counseling would be the group most likely to achieve prolonged abstinence. Asbestos-exposed smoking men undergoing screening in a mandated program for naval shipyard workers were categorized as having normal or abnormal pulmonary status on the basis of chest X ray and pulmonary function tests (PFT). They were then randomly assigned within PFT categories to receive either a simple warning or 3 to 5 min of behavioral cessation counseling from the physician who gave them the results of their pulmonary tests. Subjects' smoking status was evaluated at 3- and 11-month intervals following the physician intervention. Smokers who received behavioral counseling were more likely to quit and remain abstinent over the 11-month period (8.4% abstinent) than were smokers given a minimal warning (3.6% abstinent). Prolonged abstinence rates among abnormal PFT subjects (3.7%) did not differ from those of normals (5.9%). The group with normal PFT who received behavioral counseling achieved the highest level of abstinence (9.5%). Maintaining adequate physician compliance with the counseling protocol proved difficult; implications of this for future efforts are discussed.", "The aim of the study was to determine the smoking behavior based on \"stages of change\" model of the workers and to assess the effectiveness of a education program at a workplace. The first step was descriptive and the second step was an experimental study. The intervention group received an smoking cessation education. Before intervention 36% of the intervention group were at precontemplation stage. Six months after the intervention decline the percentage of those at precontemplation stage was significantly lower. In the control group there was not a significant reduction in the percentages of smokers at precontemplation stage before and after the intervention. After the 6 months the \"maintenance\" stage rates were 6% and 2% in the intervention and control groups, respectively. The study showed that the education in factory for workers could not be successful in quiting, however it impacted the intention and preparation of to quit in the future.", "Smoking cessation counseling is an important element of tobacco control in the workplace, but it is not easy to persuade workers to stop smoking. We performed a controlled intervention trial to evaluate the effectiveness of a new cessation program developed by Nakamura et al., which consisted of one brief individual counseling session and 4 follow-up telephone calls. Two hundred and twenty-eight smokers who visited our center for an annual health checkup were randomly divided into two group: 117 were assigned to the intervention group, and 111 were controls. Smoking status questionnaires were administered to assess the smoking habit of each subject and to evaluate their stages of change toward smoking cessation before the counseling session. Stage-matched cessation counseling was then provided to the intervention group by nurses who had completed training courses for this program. During the counseling session, carbon monoxide in expired air and nicotine metabolites in urine were measured to enhance self-perception of smoking. Only those clients who set a quit date during their counseling sessions received follow-up telephone calls. It was easy to implement this program (15 to 20 minutes long) during a health checkup. No significant differences were observed in the baseline characteristics of the two groups. The cross-sectional smoking cessation rates at 6 months and 1 year of follow-up were 6.2 times higher in the intervention group than in the control group. The continuous smoking cessation rate at 1 year of follow-up was 7.6 times higher in the intervention group than in the control group. In the intervention group, the lower level of nicotine metabolites in urine and higher smoking stage were related to cessation success, but other baseline characteristics were similar in those who quit smoking and those who did not. The effectiveness and easy applicability of this cessation program was proved in the present study. Further examinations in various settings are expected to clarify the effectiveness of this program.", "We evaluated the effects of adding a social support component to a worksite controlled smoking treatment program. Twenty-four participants were randomly assigned to either a controlled smoking or a controlled smoking plus partner support condition. Within a multiple baseline across behaviors design, smokers in both conditions made efforts to achieve sequential 50% reductions in: nicotine content of brand smoked, number of cigarettes smoked per day, and percentage of each cigarette smoked. Self-monitoring records, laboratory analyses of spent cigarette butts, and carbon monoxide determinations indicated that both conditions were effective in producing significant reductions in each of the three target behaviors and in carbon monoxide levels. All participants who quit smoking during the program maintained their abstinence at a 6-month follow-up, and those who did not quit were smoking less at follow-up than they had at pretest on all dependent variables. However, few differences were observed between controlled smoking and controlled smoking plus partner support conditions either during treatment or at the 6-month follow-up. Results are discussed with regard to previous worksite studies, future directions for research on social support, and variables that may have mediated treatment outcome.", "The effectiveness of a comprehensive program of worksite smoking control, discouragement, and cessation was compared with a program of smoking cessation alone. Two comparable oil refineries served as the research sites. Outcome variables consisted of employee self-reported smoking rate assessed by the use of a smoking questionnaire and unobtrusive observations of smoking behavior before and after the intervention. One company was randomly assigned to the comprehensive program of smoking control, discouragement, and cessation while the other company only received smoking cessation. Humorous antismoking posters emphasizing the benefits of quitting smoking were distributed throughout the first worksite and changed every 2 weeks. Large banners stating \"Go SmokeFree\" were also placed at all locations to this plant and left up for the duration of the study. Three weeks after the initiation of the smoking discouragement program at one refinery, a group smoking cessation program was begun at both plants. At a 5-month follow-up, participants in the smoking cessation treatment at the plant receiving the comprehensive program achieved a 5-month abstinence rate of 43% in comparison with a rate of 21% at the refinery receiving only smoking cessation." ]

[ "15567010", "10834523", "11106052", "15567009", "15930213", "19255990", "16696414" ]

[ "Prophylactic ibuprofen in premature infants: a multicentre, randomised, double-blind, placebo-controlled trial.", "Prophylactic ibuprofen therapy of patent ductus arteriosus in preterm infants.", "Prophylaxis of patent ductus arteriosus with ibuprofen in preterm infants.", "Prophylactic ibuprofen versus placebo in very premature infants: a randomised, double-blind, placebo-controlled trial.", "Prophylactic ibuprofen for the prevention of intraventricular hemorrhage among preterm infants: a multicenter, randomized study.", "Prophylaxis of symptomatic patent ductus arteriosus with oral ibuprofen in very low birth weight infants.", "Oral ibuprofen prophylaxis for symptomatic patent ductus arteriosus of prematurity." ]

[ "Ibuprofen is used for treatment and prevention of patent ductus arteriosus in low-birthweight infants. Its effects on regional circulations differ from those of indometacin. Because prophylactic indometacin reduces the frequency of severe intraventricular haemorrhage and patent ductus arteriosus, we aimed to study the efficacy of early ibuprofen in reducing these outcomes in a double-blind, multicentre trial.\n Within 6 h after birth, 415 low-birthweight infants (gestational age <31 weeks) were randomly allocated ibuprofen-lysine (10 mg/kg then two doses of 5 mg/kg after 24 h and 48 h) or placebo intravenously. The primary outcome was occurrence of severe intraventricular haemorrhage; secondary outcomes were occurrence of patent ductus arteriosus and possible adverse effects of ibuprofen. Analysis was by intention to treat.\n 17 (8%) of 205 infants assigned ibuprofen and 18 (9%) of 210 assigned placebo developed severe intraventricular haemorrhage (relative risk 0.97 [95% CI 0.51-1.82]). In 172 (84%) infants of the ibuprofen group, the ductus was closed on day 3 compared with 126 (60%) of the placebo group (relative risk 1.40 [1.23-1.59]). No important differences in other outcomes or side-effects were noted; however, urine production was significantly lower on day 1 and concentration of creatinine in serum was significantly higher on day 3 after ibuprofen.\n Ibuprofen prophylaxis in preterm infants does not reduce the frequency of intraventricular haemorrhage, but does decrease occurrence of patent ductus arteriosus.", "This study was aimed at evaluating the efficacy of ibuprofen in the prophylaxis of patent ductus arteriosus (PDA) in very preterm neonates and at detecting eventual side-effects. A total of 46 preterm neonates with gestational age under 31 weeks were randomly assigned at 2 h of life: 23 to the prophylaxis group and 23 to the control group. The prophylaxis group received intravenous treatment with ibuprofen lysine (10 mg/kg), followed by 5 mg/kg after 24 h and 48 h. No placebo was given to the control group. No PDA was demonstrated at 72 h of life in 20 of the 23 babies in the ibuprofen group (87%) nor in 7 of the 23 control neonates (30.4%). All neonates with PDA received treatment with indomethacin. One neonate in the prophylaxis group and three in the control group underwent surgical ligation. Prophylaxis with ibuprofen was not associated with any significant side-effect except for food intolerance.\n Ibuprofen prophylaxis seems to be efficient in closing patent ductus arteriosus and in reducing indomethacin treatment. No significant early side-effects were found due to ibuprofen.", "The aim of our study was to evaluate whether the prophylactic use of ibuprofen would reduce the incidence of significant patent ductus arteriosus (PDA) and to confirm the effectiveness of ibuprofen as rescue treatment in closing PDA. Eighty preterm infants with gestational age less than 34 wk with infant respiratory distress syndrome (iRDS) were randomized to receive intravenous ibuprofen lysine (10 mg/kg, followed by 5 mg/kg after 24 and 48 h) either within 24 h of life (group A) or after echocardiographic diagnosis of PDA (group B). To evaluate the severity of RDS in each patient, we calculated the initial and highest values of Oxygenation Index (O.I. = mean airway pressure x FiO2 x 100/PaO2) and Ventilatory Index (V.I. = O.I. x mechanical respiratory rate). Other studied variables were ventilatory support, renal function, biochemical and haematological profiles, frequency of bronchopulmonary dysplasia (BPD), intraventricular haemorrhage (IVH), necrotizing enterocolitis (NEC) and retinopathy of prematurity (ROP). On the 3rd day of life, 8% (3/40) of patients of group A and 53% of patients (21/40) of group B (p < 0.0001) developed a significant PDA. Between patients of group B who presented PDA at 3 d of life 90% (19/21) had a closure of ductus arteriosus after ibuprofen treatment. Initial and highest values of O.I. and V.I. were similar in both groups A and B. No significant differences between the groups were observed in regard to respiratory support, renal function and frequency of BPD, IVH, NEC and ROP. Ibuprofen was not associated with adverse effects. Conclusion: Prophylactic treatment with ibuprofen reduces PDA occurrence in preterm infants with iRDS at 3 d of life in comparison with rescue treatment, but both modes are effective in closing the ductus without significant adverse effects.", "Patent ductus arteriosus is a common complication of prematurity that frequently requires surgical or medical treatment. The benefit of prophylactic treatment by indometacin, a cyclo-oxygenase inhibitor, remains uncertain compared with curative treatment. This benefit could be improved with ibuprofen, another cyclo-oxygenase inhibitor with fewer adverse effects than indometacin on renal, mesenteric, and cerebral perfusion. We aimed to compare prophylactic and curative ibuprofen in the treatment of this abnormality in very premature infants.\n We did a randomised controlled trial in infants younger than 28 weeks of gestation, who were randomly assigned to receive either three doses of ibuprofen or placebo within 6 h of birth. After day 3, symptomatic patent ductus arteriosus was treated first by open curative ibuprofen, then back-up indometacin, surgery, or both. The primary endpoint was need for surgical ligation. Analysis was per protocol.\n The study was stopped prematurely after 135 enrollments because of three cases of severe pulmonary hypertension in the prophylactic group. 65 infants received prophylactic ibuprofen, and 66 received placebo. Prophylaxis reduced the need for surgical ligation from six (9%) to zero (p=0.03), and decreased the rate of severe intraventricular haemorrhage from 15 (23%) to seven (11%) (p=0.10). However, survival was not improved (47 [71%] placebo vs 47 [72%] treatment, p=1.00), because of high frequency of adverse respiratory, renal, and digestive events.\n In premature infants, prophylactic ibuprofen reduces the need for surgical ligation of patent ductus arteriosus, but does not reduce mortality or morbidity. Therefore, it should not be preferred to early curative ibuprofen.", "Ibuprofen enhances cerebral blood flow autoregulation and was shown to protect neurologic functions after oxidative stresses in an animal model. For these reasons, we hypothesized that the prophylactic use of ibuprofen would reduce the occurrence of intraventricular hemorrhage (IVH) and its worsening toward grades 2 to 4 among preterm infants. To confirm this hypothesis, we planned the present prospective study.\n This was a double-blind, randomized, controlled trial in which preterm infants with gestational ages of <28 weeks received ibuprofen or placebo within the first 6 hours of life. The infants were assigned randomly, at 7 neonatal care units, to receive ibuprofen (10 mg/kg, followed by 5 mg/kg after 24 and 48 hours) or placebo. Serial echoencephalography was performed 24 and 48 hours after the initial cerebral ultrasound study, on postnatal days 7, 15, and 30, and at 40 weeks' postconceptional age. Grade 1 IVH or no IVH was considered a successful outcome, whereas grade 2 to 4 IVH represented failure. The rates of ductal closure, side effects, and complications were recorded.\n We studied 155 infants. Grade 2 to 4 IVH developed for 16% of the ibuprofen-treated infants and 13% of the infants in the placebo group. The occurrence of patent ductus arteriosus was less frequent only on day 3 of life in the ibuprofen group. There were no significant differences with respect to other complications or adverse effects.\n Our study demonstrated that prophylactic ibuprofen is ineffective in preventing grade 2 to 4 IVH and that its use for this indication cannot be recommended.", "Patent ductus arteriosus (PDA) is a common cause of mortality and morbidity among very low birth weight infants. Oral ibuprofen suspension has been shown to have the same efficacy and safety as intravenous indomethacin in the prevention and treatment of symptomatic PDA. With lower dosage, the prevalence of side effects may decrease without changes in efficacy.\n To evaluate the efficacy and side effects of low dose ibuprofen suspension for prevention of symptomatic PDA in very low birth weight infants.\n A prospective, double blind, randomized controlled trial was conducted on premature neonates with gestational ages between 28-32 weeks, birth weight 1500 grams or less, at the Neonatal Unit, Queen Sirikit National Institute of Child Health (QSNICH) during October 2005 to October 2006. Only infants who had PDA on echocardiogram were included in the study. Three doses of ibuprofen suspension or placebo were randomly given at the dosage of 10, 5, 5 mg/kg every 24 hours. Daily physical examination, serial laboratory evaluation and echocardiogram were used to evaluate symptomatic PDA, complications and side effects.\n Sixty-two infants were recruited in the study and randomly assigned into the study and control group. The gestational age and birthweight of the 2 groups were similar The prevalence of symptomatic PDA was less in the ibuprofen group than in placebo group (9.86% vs. 35.48%; p = 0.015). There were no differences in the prevalence of complications and adverse effects between the two groups.\n Prophylactic oral ibuprofen suspension at lower dosage results in less symptomatic PDA without significant side-effects.", "The oral suspension form of ibuprofen has been shown to have the same efficacy and safety as indomethacin in the treatment of symptomatic PDA, however its role is still questionable in the prophylaxis of symptomatic PDA.\n 1. To assess the efficacy and safety of the drug in the prevention of symptomatic PDA in premature infants. 2. To study its pharmacokinetics-pharmacodynamics relationship.\n A randomized, single-blinded, controlled study was performed on premature neonates with a gestational age between 28-32 weeks, birthweight < or = 1500 grams at the neonatal unit, Queen Sirikit National Institute of Child Health from July 2003 to April 2004. Three doses of ibuprofen suspension or placebo were given 24 hours apart. Clinical evaluation was performed daily until the 28th day of life. Echocardiogram was performed prior to the drug administration, on the 3rd and 7th day of life.\n There were 22 and 20 cases in the ibuprofen and control group respectively. The epidemiologic data between the groups before enrollment showed no significant differences. Prevalence of symptomatic PDA was lower in the ibuprofen than in the control group without any significant side effects (0/22 vs 5/20, p = 0.015 on day 3 and 0/22 vs 6/20, p = 0.006 on day 7). Comparing with the pharmacokinetic study in older children and adult, the present study revealed nearly the same Cmax but longer Tmax and T1/2 in premature neonates.\n Oral ibuprofen suspension could reduce the prevalence of symptomatic PDA without any significant side effects." ]

[ "15240203", "15732268", "11784832", "16416356", "22324056", "17473394" ]

[ "Computer-aided retraining of memory and attention in people with multiple sclerosis: a randomized, double-blind controlled trial.", "Treating learning impairments improves memory performance in multiple sclerosis: a randomized clinical trial.", "Evaluation of cognitive assessment and cognitive intervention for people with multiple sclerosis.", "Efficacy of a neuropsychological training programme for patients with multiple sclerosis -- a randomised controlled trial.", "Evaluation of rehabilitation of memory in neurological disabilities (ReMiND): a randomized controlled trial.", "Cognitive training in MS: effects and relation to brain atrophy." ]

[ "Cognitive compromise is one of the main contributing factors to activity and participation restrictions in people with multiple sclerosis (MS). Computer-aided programs are used for retraining memory and attention, but data on the efficacy of these interventions are scarce.\n To assess the efficacy of computer-aided retraining of memory and attention in people with MS impaired in these abilities.\n Randomized, double-blind, controlled trial.\n Outpatients (n=82) with subjective complaints of poor attention or memory, confirmed by a score <80th percentile in at least two tests of the Brief Repeatable Battery of Neuropsychological Tests (BRBNT).\n Participants were randomized to two computer-assisted retraining interventions: memory and attention (study arm), and visuo-constructional and visuo-motor coordination (control arm). Both groups received 16 training sessions over 8 weeks.\n Improvement of 20% or more in at least two BRBNT test scores at 8 weeks compared to baseline (primary end point). Changes in depression and health-related quality of life.\n An improvement occurred in 45% of study patients vs. 43% of control patients (odds ratio 1.07, 95% confidence interval 0.44-2.64). The study treatment was better than the control treatment only on the word list generation test (p=0.016).\n This trial does not support the efficacy of specific memory and attention retraining in MS.", "This randomized clinical trial utilized established techniques to improve new learning and memory performance in multiple sclerosis (MS) participants with learning impairment. Participants were 29 individuals with clinically definite MS with documented learning deficits, randomly assigned to the experimental or control group. The experimental group underwent eight sessions of the Story Memory Technique (SMT), while the control group participated in eight sessions of memory exercises. Neuropsychological assessment was conducted at baseline, immediately following treatment and 5 weeks later to assess outcome. When stratifying participants by degree of learning deficits, a significant treatment effect was noted. MS participants with moderate-severe impairment in learning showed a significant improvement in learning abilities when compared to controls, (t(19) =3.32, P<0.01) evident in 88% of participants in the experimental group. Little improvement was noted in MS participants with mild learning impairments. Significant self-reported improvements in memory were noted in MS participants that underwent treatment, but not those that did not undergo treatment (t(26) =2.55, P<0.01). Results indicate that learning and memory deficits in MS can be effectively treated through a memory rehabilitation program utilizing context and imagery to improve new learning. Appropriate patient selection is important, with moderately-severely impaired individuals showing significantly greater benefit from treatment.", "Cognitive problems in multiple sclerosis are common but any possible benefits of treatment remain uncertain. The aim of the study was to evaluate the benefits of providing a psychology service, including cognitive assessment and intervention, to patients with multiple sclerosis.\n The study was a single blind randomised controlled trial. A total of 240 patients with clinically definite, laboratory supported, or clinically probable multiple sclerosis were recruited from an multiple sclerosis management clinic and assessed on a brief screening battery. They were randomised into three groups. The control group received no further intervention. The assessment group received a detailed cognitive assessment, the result of which was fed back to staff involved in the patients' care. The treatment group received the same detailed cognitive assessment and a treatment programme designed to help reduce the impact of their cognitive problems. Patients were followed up 4 and 8 months later on the general health questionnaire (GHQ-28), extended activities of daily living scale, SF-36, everyday memory questionnaire, dysexecutive syndrome questionnaire, and memory aids questionnaire.\n The three groups were compared on the outcome measures at 4 and 8 months after recruitment. There were few significant differences between the groups and those that occurred favoured the control group. Overall, the results showed no effect of the interventions on mood, quality of life, subjective cognitive impairment or independence.\n The study failed to detect any significant effects of cognitive assessment or cognitive intervention in this cohort of people with multiple sclerosis.", "One aim of this project was to investigate the efficacy of a specific training programme for MS patients which also contained compensation strategies and relaxation exercises relevant to everyday life. The other aim was to check the programme's relevance to everyday life.\n 19 patients, randomised into two groups, took part in the study. The participants in the treated group completed a specific neurological training programme which began immediately after the basic testing (visit 1) and lasted 4 weeks, with a total of 12 sessions. The monitoring test was done immediately after the training programme (at visit 2) and the follow-up was 3 months later (visit 3). Both study groups were fully comparable as regards clinical and socio-demographic data and baseline intelligence level.\n The results of the cognitive training programme were especially evident in the significant improvements in executive functions (CKV) and spatial-constructional abilities (HAWIE-R). Comparison between the treated and the control group showed no significant difference in the fatigue values (MFIS). However, when the treated group was examined over the three times of measurements, the symptoms of fatigue had diminished significantly. Regarding memory, comparison of the groups showed no changes; within the treated group; however, the verbal (VLT) and nonverbal learning and memory (NVLT) improved significantly. The results for sustained attention improved in both groups over time. It must be assumed that a learning effect had occurred here. The depression values (BDI) also improved in both study groups. The follow-up questionnaire showed that 60% (6) attributed an average to above-average benefit to the training.\n To summarise, it is apparent that MS patients with mild to moderate cognitive impairment are able to profit from even a fairly brief neuropsychological training programme and to integrate much of it into their everyday lives. In view of this, it would seem appropriate to offer such a programme as standard, associated with medication.", "The evidence for the effectiveness of memory rehabilitation is inconclusive. The aim was to compare the effectiveness of two group memory rehabilitation programmes with a self-help group control.\n Single-blind randomized controlled trial.\n Participants with memory problems following traumatic brain injury, stroke or multiple sclerosis were recruited from community settings.\n Participants were randomly allocated, in cohorts of four, to compensation or restitution group treatment programmes or a self-help group control. All programmes were manual-based and comprised two individual and ten weekly group sessions.\n Memory functions, mood, and activities of daily living were assessed at baseline and five and seven months after randomization.\n There were 72 participants (mean age 47.7, SD 10.2 years; 32 men). There was no significant effect of treatment on the Everyday Memory Questionnaire (P = 0.97). At seven months the mean scores were comparable (restitution 36.6, compensation 41.0, self-help 44.1). However, there was a significant difference between groups on the Internal Memory Aids Questionnaire (P = 0.002). The compensation and restitution groups each used significantly more internal memory aids than the self-help group (P < 0.01). There were no statistically significant differences between the groups on measures of mood, adjustment and activities of daily living (P > 0.05).\n There results show few statistically significant effects of either compensation or restitution memory group treatment as compared with a self-help group control. Further randomized trials of memory rehabilitation are needed.", "Cognitive disorders are common in MS patients without any generally recommended treatment. Recent brain imaging studies show considerable neuroplasticity for cognitive tasks in MS patients, but also brain atrophy already early in the disease progression. We explored the benefits of a home-based cognitive training program for memory and working memory functions in relapsing-remitting MS patients controlling for whole brain and central brain atrophy as covariates.\n Using a single-blinded controlled study design, 42 patients were randomised into a treatment group and a control group. Home based computer training focusing on memory and working memory was started at least 4 weeks after the discontinuation of methylprednisolone treatment and lasted for 6 weeks. Two weeks later the patients were re-investigated for their clinical and cognitive performance. We assessed also quality of life (QoL), depression and fatigue using self-rating scales.\n Training had no effect on the neurological status and on QoL or fatigue. However, the treatment group showed better verbal learning, long-delay verbal memory performance, and working memory performance. The impact of treatment on long-delay verbal memory performance was independent from the extent of brain atrophy, whereas for the other findings brain atrophy played a significant role.\n An intensive home-based cognitive training program is suitable to improve the cognitive performance of MS patients. The impact of brain atrophy on rehabilitation outcome may differ for cognitive functions." ]

[ "16421461", "8257839" ]

[ "Amisulpride treatment of clozapine-induced hypersalivation in schizophrenia patients: a randomized, double-blind, placebo-controlled cross-over study.", "[Effect of suo quan pill for reducing clozapine induced salivation]." ]

[ "The beneficial effect of sulpiride augmentation of clozapine therapy for treatment-resistant schizophrenia patients is enhanced by its antisalivatory effect on clozapine-induced hypersalivation (CIH). Amisulpride, similar to sulpiride, is a substitute benzamide derivative with higher selective binding to the D2/D3 dopamine receptor. We hypothesized that add-on amisulpride would also be beneficial in controlling CIH. In a randomized, double-blind, placebo-controlled cross-over study, 20 clozapine-treated schizophrenia (DSM-IV criteria) inpatients with CIH were randomly initially assigned to add-on amisulpride (nine patients; 400 mg/day up-titrated from 100 mg/day over 1 week) or placebo (11 patients). Primary outcome was change in the five-point Nocturnal Hypersalivation Rating Scale (NHRS). Other measures included the Positive and Negative Syndrome Scale (PANSS), Clinical Global Impression scale (CGI) and Simpson-Angus Scale (SAS). Mean NHRS indices were considerably lower with amisulpride (1.79 +/- 1.25) than with placebo (2.63 +/- 1.33) [F(1,38) = 5.36, P < 0.05]. With amisulpride treatment, there was a significant improvement on the negative symptoms subscale of the PANSS [F(3,57) = 3.76, P < 0.05], but not on the SAS, CGI or other subscales of the PANSS (all F < 1). Short-term amisulpride augmentation has a strong ameliorating effect on CIH. A long-term, large-scale study with a broader dose range is warranted to evaluate the stability of this effect across time.", "40 Schizophrenic inpatients with clozapine induced salivation were divided into two groups randomly. They were treated with Suo Quan pill and a control study of the placebo (neutral pill) for reducing clozapine induced salivation. These cases were also classified by TCM Syndrome Differentiation and laboratory examinations were performed. Results: There was a significant difference in effect on salivation between the therapeutic group (21 cases) and the controlled group (19 cases), P < 0.01. According to their TCM subtypes two subtypes (Stagnation of Phlegm-Dampness and Yin Deficiency) showed the best results. No correlation between the peripheral clozapine level and salivation was found. No side effect was recorded." ]

[ "6171080", "9240801", "8139302", "9181206", "15748067", "8495017" ]

[ "A randomised study of two policies for managing default in out-patients collecting supplies of drugs for pulmonary tuberculosis in a large city in South India.", "Strategies to increase adherence with tuberculosis test reading in a high-risk population.", "Automated telephone reminders in tuberculosis care.", "Use of automated reminders for tuberculin skin test return.", "Does routine home visiting improve the return rate and outcome of DOTS patients who delay treatment?", "Evaluation of the efficacy of health education on the compliance with antituberculosis chemoprophylaxis in school children. A randomized clinical trial." ]

[ "A randomized controlled study was undertaken to compare 2 policies of default management in out-patients with smear-negative pulmonary tuberculosis attending a large chest clinic in Madras city. All the patients were due to collect monthly supplies of drugs for a year, for daily self-administration at home. In the routine (R) policy, if a patient failed to collect the drug supply on a due date, a reminder letter was posted on the fourth day and, if necessary, a health visitor visited the home a week later. In the intensive (I) policy, a health visitor visited the home on the 4th day and, if necessary, a week later and at 1 and at 2 months. The main analyses concern 150 patients (75 R, 75 I), of whom 16 R and 15 I patients had a positive culture. A total of 29 patients (11 R, 18 I) did not default at any time. For the remaining 64 R and 57 I patients, the mean numbers of defaults were 3.0 and 2.3, and the mean numbers of defaulter retrieval actions were 4.3 and 3.8, respectively. The home visit as the first action (I series) was successful in retrieving defaulters on 65% of 132 occasions, while the reminder letter (R series) was successful in 56% of 193 occasions (P = 0.1). Following the second action, which was a home visit in both the series, these proportions became 80% and 84%, respectively. in the I series, 22 third and 18 fourth actions were taken, but the patient was retrieved in only 4 and 0 instances respectively. The mean number of drug collections during the year was significantly higher in the I series (9.8) than in the R series (8.6). Finally, the proportions of patients who made 12 collections in a 15-month period, a satisfactory target under Indian Programme conditions, were 69% and 52%, respectively (P = 0.07).", "To determine the most effective strategy to encourage adherence with tuberculosis test reading in a high-risk population. Design. Prospective randomized controlled trial.\n Consecutive sample of 627 children ages 1 to 12 years due for a tuberculosis (TB) test in an urban children's hospital outpatient department. One child per family was enrolled.\n All families received education regarding the importance of skin testing for TB and the need for follow-up, and written and verbal instructions regarding test reading. Families were randomly assigned to one of five strategies for follow-up TB test reading at 48 to 72 hours: 1) routine verbal and written instructions, 2) reminder phone call, 3) transportation tokens and toy on return, 4) withholding of school forms until time of reading and need to repeat TB test if not timely read, 5) parents taught to read induration with nurse home visit. Those who did not have tests read at 48 to 72 hours by a trained professional were phoned 1 week later.\n The five groups did not differ with regard to TB risk factor score, maternal education, transportation source, or perceived importance of TB testing. Before the study the follow-up rate of TB test reading by a trained professional was 45%. Reading rates in this study were 58%, 70%, 67%, 70%, and 72% for groups 1 to 5, respectively. In group 4, only 39% had school forms to be completed and their adherence rate was 84% (53/63). Compared to group 1, the only statistically significant improvement was in group 4, especially for those who needed school forms completed, and in group 5. Those not adhering in groups 1 to 4 did not differ from returnees with regard to TB risk factors, maternal education, transportation, or perceived importance of testing. The most common reasons for failing to return included forgetfulness, transportation, and time constraints. Group 5 was stopped early because of difficulty with nurse visits (N = 98). When told of the nurse visit, 9% (9/98) families could not find a time for the visit. Seventeen percent (17/98) were visited but the child was not home, and 7% (7/98) were not visited because of a nurse scheduling problem.\n In a high-risk population, adherence with TB test reading is poor. However, education and return of school forms at reading time can significantly improve adherence. Although requiring larger investment in resources, visiting nurses may also aid in test reading.", "This study assessed the impact of automated telephone reminders in a population of 2,008 patients scheduled for appointments in a public health tuberculosis clinic. Overall, remainders increased appointment attendance from 52% to 62%. Reminders were more effective for some applications than others, but the effectiveness of reminders did not differ significantly across patient age, sex, or ethnicity. Counter to theoretical predictions, neither attribution of the reminder message to an authority nor a statement stressing the importance of the appointment significantly increased the effectiveness of the reminder above the level obtained without these enhancements.", "This study assessed the impact of automated telephone reminders on tuberculin skin test returns.\n A total of 701 English-speaking and Spanish-speaking patients of a public health immunization program were randomly assigned to an intervention or a control group. Those in the intervention group received an automated telephone reminder to return for the reading of their skin test.\n Automated telephone reminders significantly reduced return failures 53% (from 14% to 7%) when the scheduled interval between test administration and reading was three days, but had no impact for a two-day interval. Effectiveness of reminders did not differ significantly by patient age, gender, or language (English versus Spanish).\n Results suggest the value of automated reminder calls for intra-appointment intervals as short as three days.", "Over a period of 6 months the effect of home visits on compliance with directly observed therapy, short course (DOTS), was studied on 480 new smear-positive tuberculosis patients who had delayed collecting their drugs on one occasion. Patients registered at 15 tuberculosis treatment centres in Baghdad, Iraq, were randomized to an intervention group (receiving home visits from trained personnel) or a control group. Home visits were highly effective in improving the return to treatment of patients who were late for treatment (231/240, 96.3%). The intervention group showed a higher treatment success rate (94.2% versus 76.7%), lower default rate (0.8% versus 10.0%) and higher smear conversion rate after the end of treatment (92.9% versus 75.0%) than controls. Home visiting by trained personnel significantly improves patient compliance with DOTS.", "Chemoprophylaxis against tuberculosis with isoniazid for 1 year is very useful, but patient compliance is very low. A controlled clinical trial was performed to evaluate the efficacy of three alternative health education strategies and to observe which of them improves compliance with antituberculosis chemoprophylaxis in healthy tuberculin-reactor children. Although all three strategies achieved positive, statistically significant results as compared with the control group, that performed by nursing personnel at the patient's home is the most effective, followed by that performed by the same health professionals by telephone. The least effective strategy by far was that performed by the physician in his surgery." ]

[ "3615572", "7508675", "6126413", "361345", "5318926", "1101843", "329786", "4865295", "2669445", "355182", "1000139", "14000409", "4889075", "13755278" ]

[ "Zuclopenthixol and perphenazine in patients with acute psychotic states. A double-blind multicentre study.", "Risperidone versus perphenazine in the treatment of chronic schizophrenic patients with acute exacerbations.", "Comparison of efficacy of a new butyrophenone derivative, timiperone and perphenazine in schizophrenia by a multicentre controlled study.", "Loxapine versus perphenazine in psychotic patients. A double-blind, randomized, multicentre trial.", "The comparative effectiveness of eight phenothiazines.", "Amitriptyline-perphenazine interaction in ambulatory schizophrenic patients. A controled study of drug interaction.", "Phenothiazine-induced ECG abnormalities: effect of a glucose load.", "A double-blind trial of amitriptyline/perphenazine, perphenazine and placebo in chronic withdrawn inert schizophrenics.", "Sulpiride and perphenazine in schizophrenia. A double-blind clinical trial.", "Double-blind comparison of bromperidol and perphenazine.", "Clozapine versus perphenazine: the value of the biochemical mode of action of neuroleptics in predicting their therapeutic activity.", "Withdrawal of perphenazine in chronic schizophrenia.", "[Clinical comparison of methophenazine and perphenazine in schizophrenia. A controlled study. Effects on the photomyoclonic threshold].", "The comparative effectiveness of six phenothiazine compounds, phenobarbital and inert placebo in the treatment of acutely ill patients: global measures of severity of illness." ]

[ "Fifty-four patients with acute psychotic states were included in a double-blind multicentre study of zuclopenthixol and perphenazine given orally. Fourteen patients had not received test preparations for a minimum of 3 weeks as stated in the protocol, and were excluded. The remaining 40 patients received the test preparations for 3 to 12 weeks, with an average of 49 days for patients receiving zuclopenthixol and 45 days for patients receiving perphenazine. Clinical evaluations were done at baseline and at weeks 1, 2, 4, 6, 8, and 12 including the CGI, a CPRS subscale for schizophrenia, and the UKU Side Effects Rating Scale. The patients received on average 37 mg zuclopenthixol or 30 mg perphenazine daily. Statistically, significant reductions on the CGI, severity of illness, and on the CPRS (total score) were found for both drugs when comparing baseline with later scores. No significant differences between the drugs were found. It was also impossible to demonstrate a difference in clinical profile between the two drugs on the basis of the single items on the CPRS. Although small differences between the two drugs were found, as regards number and type of side effects, it is concluded that the pattern of side effects was almost identical in the two treatment groups.", "Risperidone (RIS), a new neuroleptic with 5-HT2- and dopamine D2 receptor-blocking properties, was compared with perphenazine (PER) in a double-blind, multicentre, parallel-group study in 107 chronic schizophrenics with acute exacerbation. RIS 5-15 mg or PER 16-48 mg daily was given for 8 weeks. Psychopathology was assessed with the Positive and Negative Syndrome Scale (PANSS) and Clinical Global Impression. Seventy-eight patients completed the trial; there was an equal number of dropouts on both drugs. The mean daily dose at endpoint was 8.5 mg RIS and 28 mg PER. The reduction in total PANSS score to endpoint did not differ significantly, although there was a tendency in favour of RIS. The number of patients with predominantly negative symptoms who showed at least 20% reduction in total PANSS score was significantly larger in the RIS group. Furthermore, the number of patients showing at least 20% reduction in Brief Psychiatric Rating Scale (BPRS) score (BPRS being a subscale of PANSS) was significantly larger in the RIS group. The hostility cluster of BPRS improved more on RIS than on PER in the endpoint analysis. The overall prevalence of side effects was fairly similar in the two groups.", "The efficacy of timiperone in schizophrenia as compared with perphenazine was assessed in a double-blind fashion in 205 patients throughout a 12-week treatment period. More than half of the subjects were chronic schizophrenics. Global improvement in the timiperone treatment group was superior to that in the perphenazine group in view of a lower rate of aggravation. With regard to overall safety and general usefulness rating, there were no significant differences between the two drug treatments. However, timiperone showed less frequency of excitability, irritability, anxiety and anorexia than perphenazine on occasions during the 12 week treatment period. From these results it may be concluded that the efficacy of timiperone could be superior or equivalent to that of perphenazine which has been confirmed to be of use as an antipsychotic.", "A double-blind, randomized, multicentre trial was carried out in 47 psychotic patients to evaluate the efficacy of oral treatment with loxapine compared with perphenazine. In total, 22 patients were included in diagnostic Group I (cases of acute schizophrenia and psychogenic (reactive) psychoses). The average maximum daily dose was 60.0 mg in the loxapine group and 36.8 mg in the perphenazine group. After 3-weeks' treatment, no significant differences were found between the two treatment groups according to the Brief Psychiatric Rating Scale (BPRS), Clinical Global Impression (CGI) Scale or side-effect records. Twenty-five patients were included in diagnostic Group II (cases of chronic schizophrenia). The average daily dosage was 81.1 mg in the loxapine group and 90.1 mg in the perphenazine group. After 10 to 12-weeks' treatment, no significant differences between the two treatment groups could be found according to BPRS, CGI scale, Nurses' Observation Scale for In-patient Evaluation (NOSIE) or side-effect records. The diastolic blood pressure (lying and standing) tended to increase slightly in both treatment groups. In conclusion, it was found that loxapine and perphenazine seemed to be equally effective and, based on experience with parenteral loxapine treatment, it is suggested that further investigation of oral loxapine should be carried out in psychotic patients in whom agitation is a feature.", "nan", "In a double-blind placebo, controlled clinical study, lasting 12 weeks, 48 male and 48 female ambulatory schizophrenic patients were randomly assigned to one of four treatments: placebo; amitriptyline hydrochloride, 125 mg/day; perphenazine, 20 mg/day; or amitriptyline-perphenazine, 20 mg/day. Treatment groups contained an equal number of male and female patients. Perphenazine alone or in combination was substantially more effective in reducing psychopathological disorder than was the placebo, but there was no evidence to indicate the superiority of the amitriptyline-perphenazine combination over perphenazine alone. Amitriptyline alone was not substantially better than placebo and could not be considered an efficacious medication for the maintenance treatment of these patients. Less response to treatment was made by patients with longer-term records of prior hospitalization.", "A total of 54 schizophrenic patients, 27 male and 27 female, satisfying study criteria, were randomly assigned to one of three treatments: placebo; perphenazine, 20 mg/day; or the combination of amitriptyline, 125 mg/day, with perphenazine, 20 mg/day. Medication was administered under double-blind conditions for 12 weeks, after which ECGs were taken following an overnight fast and again following a 600-calorie meal. Among patients receiving perphenazine or amitriptyline-perphenazine, there was a statistically significant increase in repolarization abnormally after eating, whereas placebo-treated patients incurred no such increases. This supports the hypothesis that phenothiazine-induced ECG changes may be caused or facilitated by the glucose load. The incidence of increase in repolarization abnormality after the meal was higher among female patients than among male patients. The findings are of practical significance for readings of abnormality in the ECG of phenothiazine-treated patients.", "nan", "Seventeen patients with acute schizophrenia and 30 with chronic schizophrenia were included in a randomized, double-blind parallel-group trial comparing sulpiride and perphenazine. Patients were evaluated using the 16-item Brief Psychiatric Rating Scale (BPRS) prior to the onset of treatment and 1 and 2 weeks, and 1, 2, 3, and 4 months thereafter. In patients with acute schizophrenia, total BPRS scores declined significantly at the end of the trial compared with pretreatment values in sulpiride-treated patients but not in schizophrenics treated with perphenazine. Differences in response between the groups did not reach statistical significance, however. For patients suffering from chronic schizophrenia, a statistically significant decline was observed in total BPRS scores at 4 months compared with pretreatment scores in both sulpiride and perphenazine groups. There was no significant difference in the treatment response between the groups. Sulpiride appeared to be somewhat more effective than perphenazine for treatment of acute schizophrenia. Efficacy of both compounds was less marked in chronic forms of schizophrenia.", "Within the scope of a clinical double-blind study, effects and side effects of Bromperidol and Perphenazine were compared. Forty newly-hospitalized schizophrenic patients were included in the trial. Assessments were made on days 0, 2, 5, 10, 20, and 30. Data were documented by means of the AMP system, the EPRS scale of Simpson and Angus, and a Brief Ward Behaviour Rating Scale. Laboratory tests and ECGs were performed before and after treatment. Treatment was scheduled for 30 days and dosages were established depending on effects and side effects. We found a therapeutic effective mean daily dose of 6 mg for Bromperidol and 20 mg for Perphenazine. Both substances caused autonomic and extrapyramidal side effects and, in a few patients, temproary fatigue. The employed dosage caused no strong sedation. To sum up, Bromperidol and Perphenazine can be described as highly potent and well tolerated antipsychotic drugs. We observed stronger efficacy and earlier onset of action with Bromperidol. The superior effect of Bromperidol cannot be explained by a higher dosage as compared with Perphenazine, since both substances showed a similar severity of extrapyramidal side effects, and the dosage of both substances was established individually for each patient, depending on effects and side effects.", "The chemical structure of a neuroleptic does not relaibly predict the exact profile of its therapeutic action. We considered the question whether the biochemical action of a neuroleptic, and specifically the ratio between DA-receptor block and NA-receptor block, might have a higher predictive value in this respect. In this context we carried out a double-blind study of the therapeutic value of clozapine and perphenazine in acute psychoses of varying symptomatology anc aetiology. There are strong indications that clozapine has only a slight inhibitory effect on transmission in central DA-ergic neurons, but markedly inhibits transmission in central NA-ergic neurons, and that the reverse applies to perphenazine. In view of these data we expected perphenazine to be a stronger antipsychotic and a weaker sedative than clozapine, and vice versa. The plausibility of this hypothesis was demonstrated. Partly also on the basis of earlier research, we concluded that the biochemical action of a neuroleptic is a more faithful predictor of its therapeutic action profile than the chemical structure.", "nan", "nan", "nan" ]

[ "5524283", "4613287", "10439", "1526694", "15140776", "4283768", "4861386" ]

[ "Some aspects in the quantitation of inflammation in joints of patients suffering from rheumatoid arthritis.", "Isotopic indices as a measure of inflammation in rheumatoid arthritis.", "Evaluation of analgesic action and efficacy of antirheumatic drugs. Study of 10 drugs in 684 patients with rheumatoid arthritis.", "Endocrine control of inflammation: rheumatoid arthritis double-blind, crossover clinical trial.", "A randomised placebo controlled 12 week trial of budesonide and prednisolone in rheumatoid arthritis.", "Ibuprofen in rheumatoid arthritis. Clinical study of analgesic and anti-inflammatory activity.", "Clinical measurement of the anti-inflammatory effects of salicylates in rheumatoid arthritis." ]

[ "nan", "nan", "A single-blind non-crossover method for assessing the potential effectiveness of antirheumatic drugs has been described. The method employs entirely subjective indices and incorporates a daily pain chart for measuring the pain response over the duration of the trial. In addition, the mean number of days withdrawn and patients' satisfaction rating are measured. The statistical method can correct for initial imbalances between groups and allows for the valid comparison of drugs from separate trials. Ten antirheumatic medications were evaluated using this technique in 684 patients with rheumatoid arthritis, and the results are in agreement with those of previous studies using standard clinical methods. The new method is simple, rapid in performance, economical in terms of cost and time, and has been shown to be sensitive and reproducible. The results indicate that there are no significant differences in efficacy between the currently available non-steroidal, anti-inflammatory analgesic drugs, in the treatment of rheumatoid arthritis.", "A dysfunction in the endocrine control system for inflammation in rheumatoid arthritis serves as the theoretical basis for chronic inflammation in the study design described. Eighteen patients with rheumatoid arthritis, who acted as their own controls, were brought to a minimum symptom state through conventional means, trained, and allowed to control subsequent flares by a patient-initiated, flare-response prednisone regimen. The six-month trial was double-blind with a crossover at midpoint. While continuing stable non-steroidal anti-inflammatory and disease modifying antirheumatic drug therapies, the patients averaged additional 57% and 75% reductions from baseline in tender joint count and total pain score, respectively, on the prednisone therapy. The prednisone therapy was differentiated by improvement from that of a placebo by six of the nine parameters evaluated. The adverse events were no more frequent with prednisone than with placebo use. The efficacy of prednisone was increased threefold while reducing consumption by 40% when compared to the predecessor 5-mg prednisone/day clinical trial.", "To compare budesonide, a locally acting glucocorticoid with minimal systemic exposure, with conventional glucocorticoid treatment and placebo in rheumatoid arthritis.\n A double blind, randomised, controlled trial over 12 weeks in 143 patients with active rheumatoid arthritis, comparing budesonide 3 mg daily, budesonide 9 mg daily, prednisolone 7.5 mg daily, and placebo. Particular attention was paid to the pattern of clinical response and to changes in the four week period following discontinuation of treatment.\n There were improvements in tender joint count and swollen joint count on budesonide 9 mg compared with placebo (28% for tender and 34% for swollen joint counts, p<0.05). Prednisolone 7.5 mg gave similar results, while budesonide 3 mg was less effective. ACR20 response criteria were met by 25% of patients on placebo, 22% on budesonide 3 mg, 42% on budesonide 9 mg, and 56% on prednisolone 7.5 mg. A rapid and significant reduction in symptoms and signs in response to budesonide 9 mg and prednisolone 7.5 mg was evident by two weeks and maximal at eight weeks. There was no evidence that budesonide provided a different pattern of symptom control from prednisolone, or that symptoms became worse than placebo treatment levels after discontinuation of glucocorticoid treatment. Adverse effects attributable to glucocorticoids were equally common in all groups.\n The symptomatic benefits of budesonide 9 mg and prednisolone 7.5 mg are achieved within a short time of initiating treatment, are maintained for three months, and are not associated with any rebound in symptoms after stopping treatment.", "nan", "nan" ]

[ "9835439" ]

[ "Inhaled salbutamol and beclomethasone for preventing broncho-pulmonary dysplasia: a randomised double-blind study." ]

[ "Early inflammatory lesions and bronchial hyperresponsiveness are characteristics of the respiratory distress in premature neonates and are susceptible to aggravation by assisted ventilation. We hypothesized that treatment with inhaled salbutamol and beclomethasone might be of clinical value in the prevention of bronchopulmonary dysplasia (BPD) in ventilator-dependent premature neonates. The study was double-blinded and placebo controlled. We studied 173 infants of less than 31 weeks of gestational age, who needed ventilatory support at the 10th postnatal day. They were randomised to four groups and received either placebo + placebo, placebo + salbutamol, placebo + beclomethasone or beclomethasone + salbutomol, respectively for 28 days. The major criteria for efficacy were: diagnosis of BPD (with score of severity), mortality, duration of ventilatory support and oxygen therapy. The trial groups were similar with respect to age at entry (9.8-10.1 days), gestational age (27.6-27.8 weeks), birth weight and oxygen dependence. We did not observe any significant effect of treatment on survival, diagnosis and severity of BPD, duration of ventilatory support or oxygen therapy. For instance, the odds-ratio (95% confidence interval) for severe or moderate BPD were 1.04 (0.52-2.06) for inhaled beclomethasone and 1.54 (0.78-3.05) for inhaled salbutamol.\n This randomised prospective trial does not support the use of treatment with inhaled beclomethasone, salbutamol or their combination in the prevention of BPD in premature ventilated neonates." ]

[ "12382151", "8957021", "9221964", "17606880", "10960293", "7673949", "19334068" ]

[ "A randomised controlled trial of intravenous immunoglobulin in IgM paraprotein associated demyelinating neuropathy.", "A controlled study of intravenous immunoglobulin in demyelinating neuropathy with IgM gammopathy.", "A randomised clinical trial comparing interferon-alpha and intravenous immunoglobulin in polyneuropathy associated with monoclonal IgM. The IgM-associated Polyneuropathy Study Group.", "Intermittent cyclophosphamide with prednisone versus placebo for polyneuropathy with IgM monoclonal gammopathy.", "A randomised double blind trial versus placebo does not confirm the benefit of alpha-interferon in polyneuropathy associated with monoclonal IgM.", "Plasma exchange and chlorambucil in polyneuropathy associated with monoclonal IgM gammopathy. IgM-associated Polyneuropathy Study Group.", "Placebo-controlled trial of rituximab in IgM anti-myelin-associated glycoprotein antibody demyelinating neuropathy." ]

[ "This multicentre randomised double blind crossover trial tested the short term efficacy of intravenous immunoglobulin (IVIg) 2.0 g/kg given over 24 or 48 hours in patients with paraproteinaemic demyelinating neuropathy (PDN). Twenty-two patients were randomised and completed the trial. After 2 weeks, the overall disability grade decreased during both IVIg treatment and placebo but neither change was significant nor was the mean difference between the treatment effects. After 4 weeks the overall disability decreased by a mean of 0.55 [0.67] grades during the IVIg period (p = 0.001) while it was substantially unmodified during the placebo period. The mean difference between the treatment effects was significant (p = 0.05). Overall during the IVIg period 10 patients improved and 11 were stable and one got worse. During the placebo period 4 patients improved, 4 deteriorated and 14 were stable. Many secondary outcome measures, including Rankin scale, time to walk 10 metres, grip strength, sensory symptoms score were significantly better during IVIg treatment. Two serious adverse events occurred during the trial, both during placebo treatment. In conclusion the trial showed some short-term benefit of IVIg in about half of the patients confirming previous observation.", "Eleven patients with demyelinating polyneuropathy associated with monoclonal IgM antibodies were randomized to receive IVIg or placebo, monthly, for 3 months in a double-blind study. After a washout period, they crossed over to the alternate therapy. Response was gauged by evaluating muscle strength, sensation, and neuromuscular symptoms at baseline, after 3 months, and at treatment's end. After IVIg therapy, the strength improved in only 2 of 11 patients, by 28 and 38.5 points from baseline, and declined after placebo. In 1 other patient, the sensory score improved by 13 points. Antibody titers to MAG/SGPG or gangliosides did not appreciably change. We conclude that IVIg has only a modest benefit to not more than 18% of patients with IgM paraproteinemic demyelinating neuropathy.", "The polyneuropathy associated with a monoclonal IgM directed to the myelin associated glycoprotein (MAG) is a specific entity with a putative causal link between the IgM and the neuropathy. The small benefit offered by alkylating agents or plasma exchanges in these patients justifies the search for alternative treatments.\n A 12 month multicentre, prospective, randomised, open clinical trial was carried out comparing intravenous immunoglobulin (IVIg; 2g/kg and then 1 g/kg every three weeks) and recombinant interferon-alpha (IFN-alpha; 3 MU/m2 subcutaneously three times weekly). The main end point was a clinical neuropathy disability score (CNDS) after six months of treatment. Twenty patients were enrolled; 10 were assigned to IVIg and 10 to IFN-alpha.\n At six months, one out of 10 patients treated with IVIg had a CNDS improvement of more than 20% whereas eight out of 10 patients treated with IFN-alpha had such an improvement (P=0.005). The mean CNDS worsened by 2.3 (SD 7.6) (8%) in the IVIg group whereas it improved by 7.5 (SD 11.1) (31%) in the IFN-alpha group (P=0.02). This improvement persisted after 12 months and was mainly related to an improvement of the sensory component (P=0.02) whereas the motor component was unchanged (P=0.39). Electrophysiological data did not show improvement of motor nerve conduction velocities whereas sensory nerve conduction velocities improved in the upper limbs. A decrease in the level of the monoclonal IgM was seen in two patients treated with IFN-alpha. At the end of the treatment, antibody activity to MAG was still detected in the serum of all patients.\n IVIg, as used in this study, did not improve patients with polyneuropathy and monoclonal IgM. By contrast, although its mechanism of action remains to be fully elucidated, IFN-alpha was effective in eight out of 10 patients at six months.", "The best treatment for polyneuropathy associated with IgM monoclonal gammopathy (MGUS) is unknown. Oral cyclophosphamide combined with prednisone showed limited efficacy in a previous open label pilot study. We therefore performed a double-blind, randomized, placebo-controlled study of combined oral cyclophosphamide and prednisone in IgM MGUS polyneuropathy.\n Thirty-five patients with progressive IgM MGUS polyneuropathy were included. After stratification for anti-MAG antibodies patients were randomized to oral cyclophosphamide 500 mg once daily for 4 days combined with oral prednisone 60 mg once daily for 5 days (treatment) (n = 16), or placebo (n = 19), repeated every 28 days for six times. Primary outcome was improvement of the Rivermead Mobility Index (RMI). Secondary outcomes were improvement of the modified Rankin scale, Medical Research Council and sensory sum scores, levels of M protein, EMG, and Short Form-36 scale after treatment. Patients were examined at 0, 6, 12, 18, and 24 months.\n After 6 months of treatment and at later follow-up, no difference in change of the RMI between the two groups was observed. Change of the Rankin scale was similar in both groups. Other outcome parameters showed more improvement in the treatment group: the MRC sum score improved more from 6 to 24 months after treatment; the sensory sum score improved more at 6 months; the SF 36 mean health change score and physical role score improved more; and the median nerve distal conduction (abductor pollicis brevis muscle) improved more in the treatment group. The most common adverse event was nausea.\n Compared with placebo treatment, this first double-blind randomized trial with cyclophosphamide and prednisone in IgM MGUS polyneuropathy showed no beneficial effect on the functional scales, but a beneficial effect on muscle strength and sensation was observed.", "nan", "The study compared chlorambucil alone with chlorambucil in combination with plasma exchange in patients with polyneuropathy associated with monoclonal IgM. Forty four patients were prospectively randomly assigned, in a comparative open trial, to receive either 0.1 mg/kg/day chlorambucil orally, for 12 months or chlorambucil associated with 15 courses of plasma exchange, during the first four months of treatment. They were evaluated by a neuropathy disability score and nerve conduction studies. No difference was found between the two treatment groups. The average neuropathy disability score improved by 2.1 points from baseline (21.0 to 18.9) in the chlorambucil group and by 1.8 points (20.4 to 18.6) in the chlorambucil + plasma exchange group (P = 0.70). The mean motor nerve conduction velocity decreased from 20.0 to 18.2 m/s in the chlorambucil group and increased from 20.5 to 22.5 m/s in the chlorambucil + plasma exchange group (P = 0.51). A slight improvement of the sensory component of the neuropathy disability score (from 10.5 to 8.3) was noted in both groups (P = 0.01). At the end of the study and according to self evaluation, 15 patients--eight from the chlorambucil group and seven from the chlorambucil + plasma exchange group--reported clinical improvement, whereas 15--eight from the chlorambucil group and seven from the chlorambucil + plasma exchange group--reported clinical worsening. Neuropathy remained stable in the others. Thus plasma exchange seemed to confer no additional benefit in the treatment of polyneuropathy associated with monoclonal IgM.", "Report a double-blind, placebo-controlled study of rituximab in patients with anti-MAG demyelinating polyneuropathy (A-MAG-DP).\n Twenty-six patients were randomized to four weekly infusions of 375 mg/m(2) rituximab or placebo. Sample size was calculated to detect changes of > or = 1 Inflammatory Neuropathy Course and Treatment (INCAT) leg disability scores at month 8. IgM levels, anti-MAG titers, B cells, antigen-presenting cells, and immunoregulatory T cells were monitored every 2 months.\n Thirteen A-MAG-DP patients were randomized to rituximab and 13 to placebo. Randomization was balanced for age, electrophysiology, disease duration, disability scores, and baseline B cells. After 8 months, by intention to treat, 4 of 13 rituximab-treated patients improved by > or = 1 INCAT score compared with 0 of 13 patients taking placebo (p = 0.096). Excluding one rituximab-randomized patient who had normal INCAT score at entry, and thus could not improve, the results were significant (p = 0.036). The time to 10m walk was significantly reduced in the rituximab group (p = 0.042) (intention to treat). Clinically, walking improved in 7 of 13 rituximab-treated patients. At month 8, IgM was reduced by 34% and anti-MAG titers by 50%. CD25+CD4+Foxp3+ regulatory cells significantly increased by month 8. The most improved patients were those with high anti-MAG titers and most severe sensory deficits at baseline.\n Rituximab is the first drug that improves some patients with A-MAG-DP in a controlled study. The benefit may be exerted by reducing the putative pathogenic antibodies or by inducing immunoregulatory T cells. The results warrant confirmation with a larger trial." ]

[ "6341847" ]

[ "Penicillin in infants weighing two kilograms or less with early-onset Group B streptococcal disease." ]

[ "We studied the effect of penicillin on early-onset Group B streptococcal disease over a 52-month period in neonates who were at high risk of infection. Shortly after birth, 1187 neonates weighing 2000 g or less had blood samples taken for cultures and were randomized into an early-treatment group (given intramuscular penicillin G within 60 minutes of birth) or a control group. The incidence of early-onset disease was 20 per 1000 live births (24 of 1187); the number of infants in the early-treatment group who had disease (10 of 589) was similar to that in the control group (14 of 598). The fatality rates were similar in both groups (6 of 10 vs. 8 of 14). Cultures from blood obtained with one hour of birth were positive in 21 of the 24 infants with disease; 22 of the 24 were symptomatic within four hours of birth. Thus, infection was well established before the first hour of postnatal life. At autopsy, gram-positive cocci were seen in lung sections of four infants in whom cultures of blood obtained after treatment had been sterile; this indicates that giving routine antibiotic therapy before culture samples are obtained can obscure bacteriologic diagnosis. We conclude that penicillin given at birth to neonates weighing 2000 g or less does not prevent early-onset streptococcal disease or reduce excess mortality associated with disease." ]

[ "16489888", "15174791" ]

[ "In-line filters in central venous catheters in a neonatal intensive care unit.", "The use of in-line intravenous filters in sick newborn infants." ]

[ "Nosocomial sepsis remains an important cause of morbidity in neonatal intensive care units. Central venous catheters (CVCs) and parenteral nutrition (TPN) are major risk factors. In-line filters in the intravenous (IV) administration sets prevent the infusion of particles, which may reduce infectious complications. We randomized infants to in-line filter (for clear fluids and lipid emulsions) or no filter placement. Sepsis, nursing time and costs were assessed. IV sets without filters were changed every 24 h, IV-sets with filters every 96 h. Of 442 infants with a CVC, 228 were randomized to filter placement, 214 to no filter. No differences were found in clinical characteristics, CVC-use, and catheter days. Nosocomial sepsis occurred in 37 (16.2%) infants with filters, in 35 (16.3%) in the group without filter (NS). Nursing time to change the IV-administration sets was 4 min shorter in the filter-group (P<0.05). Costs of materials used were comparable. In conclusion, the incidence of sepsis when using filters was not reduced but the nursing time for changing the intravenous sets was reduced without a difference in costs.", "This study assesses the improvement in outcome for newborn infants by decreasing major complications associated with intravenous fluid therapy by using an in-line filter, and evaluates the economical impact this might have in relation to daily changing of i.v. lines.\n In a prospective controlled study, 88 infants were randomly assigned to receive either filtered (except for lipids, blood and blood products) or non-filtered infusions via a central catheter. Main outcome measures such as bacteraemia, phlebitis, extravasation, thrombosis, septicaemia and necrosis were all scored. The costs attributable to patients during a standard 8-day stay were also recorded.\n Significant reductions were found in major complications such as thrombi and clinical sepsis (control group (21), filter group (8); p < 0.05). Bacterial cultures of the filters showed a contamination rate on the upstream surface of 15/109 filters (14%). The mean costs of disposables were less in the filter group, showing a reduction from 31.17 euros to 23.79 euros.\n The use of this in-line filter leads to a significant decrease in major complications and substantial cost savings." ]

[ "799563", "16580575", "7019167", "2645914", "8021909", "2183868", "786673", "1704983", "2676651", "1740538", "7050009", "8018001" ]

[ "Evaluation of the effect of timolol alone and in combination with hydrochlorothiazide and amiloride in the treatment of mild to moderate arterial hypertension: a double-blind, controlled study.", "A factorial study of combination hypertension treatment with metoprolol succinate extended release and felodipine extended release results of the Metoprolol Succinate-Felodipine Antihypertension Combination Trial (M-FACT).", "Timolol maleate and hydrochlorothiazide in control of essential hypertension: use of a fixed combination for once-a-day administration.", "Nicardipine and propranolol in the treatment of essential hypertension.", "Placebo-controlled comparison of the effects of nebivolol and low-dose hydrochlorothiazide as monotherapies and in combination on blood pressure and lipid profile in hypertensive patients.", "Comparison of once daily atenolol, nitrendipine and their combination in mild to moderate essential hypertension.", "Hypotensive effect of oxprenolol in mild to moderate hypertension: a multicentre controlled study.", "Antihypertensive efficacy and tolerability of a fixed combination of metoprolol and felodipine in comparison with the individual substances in monotherapy. The Swedish/United Kingdom Study Group.", "Chlorthalidone alone or in fixed combination with slow-release metoprolol in the management of arterial hypertension: a long-term study of 545 patients.", "Antihypertensive and metabolic effects of single and combined atenolol regimens.", "Metolazone and pindolol in the treatment of hypertension: a double blind multicentre trial.", "A multifactorial trial design to assess combination therapy in hypertension. Treatment with bisoprolol and hydrochlorothiazide." ]

[ "1. The effects of timolol alone and in combination with a fixed dose of hydrochlorothiazide and amiloride have been studied in a double-blind, controlled study in fifty-four patients with mild to moderate essential hypertension. 2. After a 4 weeks placebo period patients were randomly assigned to enter groups receiving timolol alone (group A), hydrochlorothiazide + amiloride (group B) or timolol + hydrochlorothiazide + amiloride (group C). Each treatment was carried out for 6 weeks. 3. The use of timolol (10 mg), hydrochlorothiazide (25 mg) and amiloride (2-5 mg) in a combination tablet given twice daily gave better control of blood pressure in patients with mild to moderate essential hypertension than did equivalent dosages of timolol alone or of hydrochlorothiazide and amiloride. 4. Clinical and laboratory side effects were minimal.", "Many hypertensive patients require combination therapy to achieve target blood pressure (BP). beta-Blockers and dihydropyridine calcium channel blockers are effective as monotherapy in hypertensive patients and have complementary mechanisms for lowering BP.\n This multicenter, randomized, placebo-controlled, unbalanced factorial study included a 4- to 5-week single-blind placebo, 9-week, double-blind treatment as well as a 2-week double-blind, down-titration period. Patients (N = 1092) were randomized to one of 16 treatment groups: extended-release (ER) metoprolol succinate (25, 100, or 400 mg), ER felodipine (2.5, 10, or 20 mg), ER felodipine/ER metoprolol succinate (2.5/25, 2.5/100, 2.5/400, 10/25, 10/100, 10/400, 20/25, 20/100, or 20/400 mg), or placebo.\n At baseline, treatment groups were well balanced; mean sitting BP was 152.6/99.9 mm Hg. Monotherapy with ER metoprolol succinate induced dose-related reductions in sitting systolic/diastolic BP (DBP) (mean 8.1/7.7 to 9.7/11.1 mm Hg) as did ER felodipine (mean 7.7/7.7 to 14.0/11.8) and the combinations reflected additive effects (mean 13.8/11.0 to 19.8/15.2). The decline in the placebo group was 2.1/4.0 mm Hg. All combinations were more effective than their components (P < .05 for all but ER metoprolol succinate 25/ER felodipine 20). When compared with the highest doses of the individual agents (ER metoprolol succinate 400 mg; ER felodipine 20 mg), the low-dose combination ER metoprolol succinate 25/ER felodipine 2.5 was approximately as effective (differences in DBP <1 mm Hg). The most common adverse events leading to discontinuation were peripheral edema (4%), headache (2%), and fatigue (1%). Higher rates of peripheral edema and flushing were associated with high-dose ER felodipine, either alone or in combination.\n The antihypertensive effects of ER metoprolol succinate and ER felodipine are dose-related, and when given in combination, their BP-lowering effects are additive over a wide dose range. Low-dose combination therapy is comparable in effectiveness to high-dose monotherapy but is better tolerated.", "nan", "Two hundred thirty-four patients with supine diastolic blood pressure of between 95 and 114 mm Hg were enrolled into a double-blind, randomized, parallel, multicenter trial. The patients were randomized to either nicardipine 30 mg tid, propranolol 40 mg tid, or nicardipine 30 mg tid and propranolol 40 mg tid for six weeks. Two hundred six patients yielded data for analyses. Of the 28 not included, seven had missing data, whereas the remaining 21 were excluded because they either failed to meet inclusion criteria or were noncompliant at endpoint. Both nicardipine and propranolol as monotherapies and in combination achieved statistically significant, (P less than .01), supine diastolic blood pressure reduction relative to baseline. The combination of nicardipine and propranolol showed a greater reduction in supine diastolic and systolic measurements than either of the monotherapies. Nicardipine produced greater blood pressure reductions one hour after dosing, whereas the propranolol treatment tended to produce slightly greater blood pressure decreases eight hours after dose. The combination always resulted in the greatest blood pressure reduction, independent of time after dose. Adverse experiences were reported by 26% of patients in the nicardipine-treated group, most often transient vasodilatory effects, by 17% of the propranolol-treated patients, and by 18% of the combination-treated group. This study demonstrated at the doses studied that nicardipine alone produced equivalent blood pressure reductions to those obtained by propranolol alone, but that the combination of these two drugs produced greater reductions in blood pressures than either of the monotherapies.", "The effects of nebivolol, a new beta-blocker with vasodilating properties, and hydrochlorothiazide (HCTZ) as monotherapies and in combination on BP and plasma lipids, lipoproteins and apolipoproteins were compared with placebo in a parallel 3 x 4 factorial design study. After an eight week wash-out period, 240 patients with primary hypertension were randomised to receive either placebo, nebivolol 1, 5 or 10 mg, HCTZ 12.5 or 25 mg or one of the six possible combinations of nebivolol and HCTZ. Twenty patients were assigned to each of the 12 parallel groups. After 12 weeks of treatment, there was a significant dose-related reduction in BP among all active treatment groups. Apart from a slight and isolated increase in triglycerides with HCTZ 12.5 mg, lipid, lipoprotein and apolipoprotein levels as well as lipoprotein and apolipoprotein ratios were not significantly modified by 12 week active treatments when compared with placebo treatment. The results of this multifactorial study with 12 small sample size groups, suggest that nebivolol as monotherapy and in combination with HCTZ does not cause deleterious effects on the lipid profile.", "1. The aim of the study was to compare the efficacy and the tolerability of treatment with atenolol (50-100 mg once daily), nitrendipine (20-40 mg once daily) and their combination (atenolol 50 mg + nitrendipine 20 mg) once daily in patients with mild to moderate essential hypertension. 2. The study was a randomised, double-blind, placebo controlled parallel groups design: blood pressures were measured at 'trough' effect (i.e. 24 h after dosing) to assess the adequacy of once-daily treatment. 3. Mean blood pressures (mm Hg) recorded on four occasions over 12 weeks of treatment were significantly lower both with atenolol (155/97 sitting: 155/104 standing) and with the combination of atenolol plus nitrendipine (153/96 sitting: 152/104 standing) than with placebo (169/108 sitting: 169/114 standing). Nitrendipine alone had no significant effect on blood pressure 24 h after dosing (165/104 sitting: 165/110 standing). 4. Withdrawals due to adverse effects were more common during treatment with nitrendipine: 7/32 of the patients experienced adverse effects attributable to intense systemic vasodilatation (e.g., flushing, erythema, headache). 2/37 patients taking atenolol were withdrawn: one because he developed a psoriatic rash and the other because of impaired peripheral circulation. Of the 35 patients taking combination treatment, two were withdrawn: one developed headaches and dyspnoea, and the other asthma. 5. The results suggest that once daily dosing with nitrendipine does not control blood pressure throughout the 24 h period in the majority of patients, and is associated with a considerable burden of adverse effects. Combination treatment was better tolerated but appeared to offer no advantages over atenolol alone in terms either of blood pressure control or adverse effects.", "In a multicentre, double-blind, between-patient study the hypotensive effect of oxprenolol was investigated in 329 patients with mild to moderate hypertension. A factorial experimental design with three factors was chosen: oxprenolol--none or daily doses of 20, 40, 60 and 80 mg; dihydralazine and hydrochlorothiazide, respectively, none or 30 mg daily. Each treatment was given for 4 weeks after an adequate period of withdrawal from any other possible hypotensive therapy and one week of placebo wash-out. Irresponsive of the association with dihydralazine and/or hydrochlorothiazide, oxprenolol had a hypotensive effect linearly related to dose for standing systolic (P less than 0.05) and diastolic (P less than 0.01) pressure, and for lying diastolic (P less than 0.05) pressure. The additional of dihydralazine enhanced the time-course of the hypotensive effect of oxprenolol, particularly the 80 mg dose level. In general, the combination of oxprenolol with dihydralazine and hydrochlorothiazide caused larger reductions in blood pressure, particularly with oxprenolol 80 mg. In the latter group, the eventual falls in blood pressure were 30.5 and 14.4 mmHg for lying systolic and diastolic, respectively; and 32.1 and 20.0 mmHg for the standing systolic and diastolic pressures. The drug was well tolerated; major side effects (heart failure and bronchospasm) occurred in three patients.", "In this double-blind, randomized, parallel-group study, the aim was to compare the efficacy and tolerability of a new fixed combination of felodipine and metoprolol with the individual components in monotherapy. After a placebo period of 4 weeks, 159 patients with mild to moderate essential hypertension were randomized to extended-release formulations of either felodipine plus metoprolol 10 + 100 mg (FM), felodipine 10 mg (F), or metoprolol 100 mg (M) once daily if supine diastolic blood pressure greater than 95 mm Hg. After 12 weeks of active treatment, the reductions in supine blood pressure (24 h after dosing) were 20/14, 13/10, and 11/8 mm Hg for FM, F, and M, respectively. The difference in change was 7/4 mm Hg (p = 0.004/p = 0.006) and 8/5 mm Hg (p = 0.0002/p less than 0.0001) for the fixed combination and F or M, respectively. Blood pressure control (diastolic blood pressure less than 90 mm Hg after 12 weeks) was significantly better for the combination than for F and M, i.e., 71%, 49% (p = 0.008), and 34% (p = 0.004), respectively. Adverse experiences were those to be expected from previous studies with felodipine and metoprolol and did not differ in frequency between groups. It can be concluded that a fixed combination of metoprolol and felodipine has a clinically relevant and significantly better blood pressure reduction 24 h postdose than the individual substances in monotherapy, without decreased tolerability.", "In a double-blind trial, 545 out-patients with essential hypertension received 25 mg/day chlorthalidone alone (274 patients) or in fixed combination with 200 mg/day slow-release metoprolol (271 patients) for 8 weeks. Both treatments significantly (P less than 0.001) decreased systolic and diastolic blood pressure; 45.6% of patients receiving chlorthalidone and 82.5% receiving combined therapy had a diastolic blood pressure of less than 95 mmHg. Patients not controlled by chlorthalidone or chlorthalidone plus metoprolol subsequently received chlorthalidone plus metoprolol (137 patients) or chlorthalidone plus metoprolol plus a third drug (34 patients), respectively, for 8 weeks. A total of 79.5% of patients receiving chlorthalidone plus metoprolol and 61.8% receiving chlorthalidone plus metoprolol plus a third drug had a diastolic blood pressure of less than 95 mmHg. Only 5.9% of patients experienced mild to moderate side-effects. Plasma potassium levels significantly (P less than 0.01) decreased during the first 8 weeks only. It is concluded that a diuretic alone or in fixed combination with a beta-blocker is effective in the long-term treatment of arterial hypertension.", "The antihypertensive and metabolic effects of placebo (PL), a fixed combination of hydrochlorothiazide (25 mg) and triamterene (50 mg) (HCTZ/TRI), atenolol (25 mg) (Atc-25), atenolol (50 mg) (Ate-50) and their combination with HCTZ/TRI given once daily, were tested on 256 patients with mild-to-moderate essential-hypertension. After 3 weeks of PL monotherapy, 43 patients were randomized to PL (group 1), 41 patients to HCTZ/TRI (group 2), 44 patients to Ate-25 (group 3), 42 patients to Ate-50 (group 4), 43 patients to Ate-25/HCTZ/TRI (group 5), and 43 patients to Ate-50/HCTZ/TRI (group 6) in a double-blind parallel design study and were followed for 4 weeks. At the end of week 7, those patients who were randomized to groups 5 and 6 were allowed to continue for an additional 12 weeks, if their arterial pressure was satisfactorily controlled. Complete blood counts, blood chemistries, urinalyses, and electrocardiograms were done initially and during the study. Monotherapy with HCTZ/TRI, Ate-25, and Ate-50 had significant and equal antihypertensive effects compared with placebo. (P less than .01). However, the combination of Ate-25/HCTZ/TRI and Ate-50/HCTZ/TRI resulted in further reduction of arterial pressure with the effect being greatest with Ate-50/HCTZ/TRI (P less than .001). Patient groups 3 through 6 had also slower heart rates compared with groups 1 and 2 (P less than .01). Mild, but statistically significant, increases in BUN, glucose, triglycerides, and uric acid were noted in groups 2, 5, and 6 (P less than .05).(ABSTRACT TRUNCATED AT 250 WORDS)", "nan", "The safety and effectiveness of different dosages and combinations of antihypertensive agents can be efficiently studied using a multifactorial trial design. In consultation with the Cardio-Renal Division of the Food and Drug Administration, we conducted a randomized, double-blind, placebo-controlled, 3 x 4 factorial trial of bisoprolol, a beta 1-selective adrenergic blocking agent, and hydrochlorothiazide.\n A total of 512 patients with mild to moderate essential hypertension were randomized to once-daily treatment with bisoprolol (0, 2.5, 10, or 40 mg), hydrochlorothiazide (0, 6.25, or 25 mg), and all possible combinations. Diastolic and systolic blood pressures were monitored during this 12-week trial.\n The effects of bisoprolol and hydrochlorothiazide were additive with respect to reductions in diastolic and systolic blood pressures over the dosage ranges studied. The addition of hydrochlorothiazide (or bisoprolol) to therapy with bisoprolol (or hydrochlorothiazide) produced an incremental reduction in blood pressure. Dosages of hydrochlorothiazide as low as 6.25 mg/d contributed a significant antihypertensive effect. A hydrochlorothiazide dosage of 6.25 mg/d produced significantly less hypokalemia and less of an increase in uric acid levels than a dosage of 25 mg/d. The low-dose combination of bisoprolol, 2.5 mg/d, and hydrochlorothiazide, 6.25 mg/d, reduced diastolic blood pressure to lower than 90 mm Hg in 61% of patients and demonstrated a safety profile that compared favorably with that of placebo.\n The utility of factorial design trials to characterize dose-response relationships and to test the potential interactions between various antihypertensive agents has been demonstrated. The combination of low dosages of bisoprolol and hydrochlorothiazide may be a rational alternative to conventional stepped-care therapy for the initial treatment of patients with mild to moderate hypertension." ]

[ "14514937", "15218994", "11866001", "11871363", "14605043", "12728159", "16761228", "16144890", "10764302", "10722768" ]

[ "Effect of tiotropium bromide on circadian variation in airflow limitation in chronic obstructive pulmonary disease.", "Effects of tiotropium on lung hyperinflation, dyspnoea and exercise tolerance in COPD.", "A long-term evaluation of once-daily inhaled tiotropium in chronic obstructive pulmonary disease.", "Improved health outcomes in patients with COPD during 1 yr's treatment with tiotropium.", "Improvement in resting inspiratory capacity and hyperinflation with tiotropium in COPD patients with increased static lung volumes.", "Health outcomes following treatment for six months with once daily tiotropium compared with twice daily salmeterol in patients with COPD.", "[Efficacy of tiotropium bromide (Spiriva) in patients with chronic-obstructive pulmonary disease (COPD) of different severities].", "Prevention of exacerbations of chronic obstructive pulmonary disease with tiotropium, a once-daily inhaled anticholinergic bronchodilator: a randomized trial.", "Long-acting bronchodilation with once-daily dosing of tiotropium (Spiriva) in stable chronic obstructive pulmonary disease.", "A randomised controlled comparison of tiotropium nd ipratropium in the treatment of chronic obstructive pulmonary disease. The Dutch Tiotropium Study Group." ]

[ "In chronic obstructive pulmonary disease (COPD), the degree of circadian variation in forced expiratory volume in 1 second (FEV1) and the influence of anticholinergic blockade is not known. Tiotropium is a long acting inhaled anticholinergic bronchodilator that increases daytime FEV1 in COPD. We hypothesised that tiotropium would modify the overnight change in FEV1, and this would be unaffected by the timing of drug administration.\n A double blind, randomised, placebo controlled trial was conducted with tiotropium 18 mg once daily in the morning (09.00 hours), evening (21.00 hours), or an identical placebo. Patients with stable COPD (n=121, FEV1=41% predicted) underwent spirometric tests every 3 hours for 24 hours at baseline and after 6 weeks of treatment.\n There were no significant differences at baseline between the groups. Tiotropium improved mean (SE) FEV1 (over 24 hours) in the morning (1.11 (0.03) l) and evening (1.06 (0.03) l) groups compared with placebo (0.90 (0.03) l), and nocturnal FEV1 (mean of 03.00 and 06.00 hours) in the morning (1.03 (0.03) l) and evening (1.04 (0.03) l) groups compared with placebo (0.82 (0.03) l) at the 6 week visit (p<0.01). FEV1 before morning or evening dosing was similar, while the peak FEV1 moved later in the day with active treatment. The mean percentage change in FEV1 from 09.00 hours to 03.00 hours (the nocturnal decline in FEV1) was -2.8% in the morning group, -1.0% in the evening group, and -12.8% in the placebo group. The magnitude of the peak to trough change in FEV1 was not statistically different.\n Tiotropium produced sustained bronchodilation throughout the 24 hour day without necessarily abolishing circadian variation in airway calibre.", "The aim of this study was to test the hypothesis that use of tiotropium, a new long-acting anticholinergic bronchodilator, would be associated with sustained reduction in lung hyperinflation and, thereby, would improve exertional dyspnoea and exercise performance in patients with chronic obstructive pulmonary disease. A randomised, double-blind, placebo-controlled, parallel-group study was conducted in 187 patients (forced expiratory volume in one second 44 +/- 13% pred): 96 patients received 18 microg tiotropium and 91 patients received placebo once daily for 42 days. Spirometry, plethysmographic lung volumes, cycle exercise endurance and exertional dyspnoea intensity at 75% of each patient's maximal work capacity were compared. On day 42, the use of tiotropium was associated with the following effects at pre-dose and post-dose measurements as compared to placebo: vital capacity and inspiratory capacity (IC) increased, with inverse decreases in residual volume and functional residual capacity. Tiotropium increased post-dose exercise endurance time by 105 +/- 40 s (21%) as compared to placebo on day 42. At a standardised time near end-exercise (isotime), IC, tidal volume and minute ventilation all increased, whilst dyspnoea decreased by 0.9 +/- 0.3 Borg scale units. In conclusion, the use of tiotropium was associated with sustained reductions of lung hyperinflation at rest and during exercise. Resultant increases in inspiratory capacity permitted greater expansion of tidal volume and contributed to improvements in both exertional dyspnoea and exercise endurance.", "Currently available inhaled bronchodilators used as therapy for chronic obstructive pulmonary disease (COPD) necessitate multiple daily dosing. The present study evaluates the long-term safety and efficacy of tiotropium, a new once-daily anticholinergic in COPD. Patients with stable COPD (age 65.2+/-8.7 yrs (mean+/-SD), n=921) were enrolled in two identical randomized double-blind placebo-controlled 1-yr studies. Patients inhaled tiotropium 18 microg or placebo (mean screening forced expiratory volume in one second (FEV1) 1.01 versus 0.99 L, 39.1 and 38.1% of the predicted value) once daily as a dry powder. The primary spirometric outcome was trough FEV1 (i.e. FEV1 prior to dosing). Changes in dyspnoea were measured using the Transition Dyspnea Index, and health status with the disease-specific St. George's Respiratory Questionnaire and the generic Short Form 36. Medication use and adverse events were recorded. Tiotropium provided significantly superior bronchodilation relative to placebo for trough FEV1 response (approximately 12% over baseline) (p<0.01) and mean response during the 3 h following dosing (approximately 22% over baseline) (p<0.001) over the 12-month period. Tiotropium recipients showed less dyspnoea (p<0.001), superior health status scores, and fewer COPD exacerbations and hospitalizations (p<0.05). Adverse events were comparable with placebo, except for dry mouth incidence (tiotropium 16.0% versus placebo 2.7%, p<0.05). Tiotropium is an effective, once-daily bronchodilator that reduces dyspnoea and chronic obstructive pulmonary disease exacerbation frequency and improves health status. This suggests that tiotropium will make an important contribution to chronic obstructive pulmonary disease therapy.", "Tiotropium, a novel once-daily inhaled anticholinergic, has been shown to improve lung function over a 24-h period. In order to extend these findings, health-outcomes were evaluated over 1 yr in chronic obstructive pulmonary disease (COPD) patients. Spirometric results, peak expiratory flow rate (PEFR), salbutamol use and effects on dyspnoea, health-related quality of life and COPD exacerbations were assessed in two identical 1-yr randomized double-blind double-dummy studies of tiotropium 18 microg once daily (n=356) compared with ipratropium 40 microg q.i.d. (n=179). Screening forced expiratory volume in one second (FEV1) were 1.25+/-0.43 L (41.9+/-12.7% of the predicted value) (tiotropium) and 1.18+/-0.37 L (39.4+/-10.7% pred) (ipratropium). Trough FEV1 at 1 yr improved by 0.12+/-0.01 L with tiotropium and declined by 0.03+/-0.02 L with ipratropium (p<0.001). Significant improvement in PEFR, salbutamol use, Transition Dyspnea Index focal score, and the St George's Respiratory Questionnaire total and impact scores were seen with tiotropium (p<0.01). Tiotropium reduced the number of exacerbations (by 24%, p<0.01), and increased time to first exacerbation (p<0.01) and time to first hospitalization for a COPD exacerbation (p<0.05) compared with ipratropium. Apart from an increased incidence of dry mouth in the tiotropium group, adverse events were similar between treatments. Tiotropium was effective in improving dyspnoea, exacerbations, health-related quality of life and lung function in patients with chronic obstructive pulmonary disease, and exceeds the benefits seen with ipratropium. The data support the use of tiotropium once-daily as first-line maintenance treatment in patients with chronic obstructive pulmonary disease.", "In patients with COPD, changes in inspiratory capacity (IC) have shown a higher correlation to patient-focused outcomes, such as dyspnea with exercise, than other standard spirometric measurements. Changes in IC reflect changes in hyperinflation. Tiotropium is a once-daily inhaled anticholinergic that has its effect through prolonged M3 muscarinic receptor antagonism and has demonstrated sustained improvements in spirometric and health outcomes. We sought to evaluate changes in resting IC and lung volumes after long-term administration of tiotropium.\n To evaluate the effect of tiotropium, 18 micro g/d, on IC, a 4-week, randomized, double-blind, placebo-controlled study was conducted in 81 patients with stable COPD. At each of the visits (weeks 0, 2, and 4) FEV(1), FVC, IC, slow vital capacity (SVC), and thoracic gas volume (TGV) were measured prior to study drug (- 60 and - 15 min) and after study drug (30 min, 60 min, 120 min, and 180 min).\n Mean age was 64 years; 62% were men. Mean baseline FEV(1) was 1.12 L (43% predicted). The mean differences (tiotropium - placebo) in FEV(1) trough (morning before drug), peak, and area under the curve over 3 h values (adjusted for baseline and center differences) at week 4 were 0.16 L, 0.22 L, and 0.22 L, respectively (p < 0.01 for all); differences in IC for these variables were 0.22 L, 0.35 L, and 0.30 L (p < 0.01 for all). Differences in TGV were - 0.54 L, - 0.60 L, and - 0.70 L, respectively (p < 0.01 for all). The percentage improvement in area under the curve above baseline with tiotropium was similar among FEV(1) and lung volumes (FEV(1), 18%; FVC, 20%; SVC, 16%; IC, 16%; TGV, 14%).\n Observed improvements in IC and reductions in TGV with once-daily tiotropium reflect improvements in hyperinflation that are maintained over 24 h.", "A study was undertaken to record exacerbations and health resource use in patients with COPD during 6 months of treatment with tiotropium, salmeterol, or matching placebos.\n Patients with COPD were enrolled in two 6-month randomised, placebo controlled, double blind, double dummy studies of tiotropium 18 micro g once daily via HandiHaler or salmeterol 50 micro g twice daily via a metered dose inhaler. The two trials were combined for analysis of heath outcomes consisting of exacerbations, health resource use, dyspnoea (assessed by the transitional dyspnoea index, TDI), health related quality of life (assessed by St George's Respiratory Questionnaire, SGRQ), and spirometry.\n 1207 patients participated in the study (tiotropium 402, salmeterol 405, placebo 400). Compared with placebo, tiotropium but not salmeterol was associated with a significant delay in the time to onset of the first exacerbation. Fewer COPD exacerbations/patient year occurred in the tiotropium group (1.07) than in the placebo group (1.49, p<0.05); the salmeterol group (1.23 events/year) did not differ from placebo. The tiotropium group had 0.10 hospital admissions per patient year for COPD exacerbations compared with 0.17 for salmeterol and 0.15 for placebo (not statistically different). For all causes (respiratory and non-respiratory) tiotropium, but not salmeterol, was associated with fewer hospital admissions while both groups had fewer days in hospital than the placebo group. The number of days during which patients were unable to perform their usual daily activities was lowest in the tiotropium group (tiotropium 8.3 (0.8), salmeterol 11.1 (0.8), placebo 10.9 (0.8), p<0.05). SGRQ total score improved by 4.2 (0.7), 2.8 (0.7) and 1.5 (0.7) units during the 6 month trial for the tiotropium, salmeterol and placebo groups, respectively (p<0.01 tiotropium v placebo). Compared with placebo, TDI focal score improved in both the tiotropium group (1.1 (0.3) units, p<0.001) and the salmeterol group (0.7 (0.3) units, p<0.05). Evaluation of morning pre-dose FEV(1), peak FEV(1) and mean FEV(1) (0-3 hours) showed that tiotropium was superior to salmeterol while both active drugs were more effective than placebo.\n Exacerbations of COPD and health resource usage were positively affected by daily treatment with tiotropium. With the exception of the number of hospital days associated with all causes, salmeterol twice daily resulted in no significant changes compared with placebo. Tiotropium also improved health related quality of life, dyspnoea, and lung function in patients with COPD.", "Aim of this study was to evaluate the efficacy of inhaled Tiotropium bromide in COPD patients of different severities in pneumological practices during a three months clinical trial.\n A randomized, double blind, placebo controlled study including COPD-patients (FEV1/FVC < 70 %, FEV1 < or = 70 % predicted; age > or = 40 years; > or = 10 pack years) of different severities was performed. The efficacy of 18 microg Tiotropium bromide once daily on lung function and exacerbations over 12 weeks was evaluated by respective pulmonary function tests (spirometry) before (trough value) and 2 hours after inhalation of study medication.\n 1639 patients (1236 Tiotropium bromide, 403 placebo; FEV1 reversibility after 200 microg Ipratropium bromide + 200 microg Fenoterol: 7.9 +/- 7.5 % predicted [mean +/- sd]) were randomized. After 12 weeks of treatment Tiotropium bromide led to significant increases of trough FEV1 (23 - 24 h after last inhalation; + 79 +/- 17 ml), and 2 h after Tiotropium bromide inhalation (+ 128 +/- 19 ml) (all values vs. placebo, adjusted mean +/- se, p < 0.0001). FVC and IVC were also improved significantly. In mild COPD (FEV1 > or = 50 - 70 %) improvements were most pronounced (trough FEV1 + 113 +/- 29 ml, 2 h post-inhalation + 181 +/- 33 ml; all values vs. placebo., p < 0.0001). 14.6 % of patients treated with Tiotropium bromide had a COPD exacerbation vs. 19.9 % of patients treated with placebo (p = 0.0151). The time to first exacerbation was prolonged (p = 0.0092 vs. placebo).\n Tiotropium bromide 18 microg once daily led to a persistent improvement of lung function and a reduction of exacerbations in patients with COPD of different severities.", "Patients with chronic obstructive pulmonary disease (COPD) frequently develop exacerbations, leading to major clinical and health resource use ramifications.\n To prospectively evaluate the effectiveness of a long-acting inhaled anticholinergic bronchodilator, tiotropium, in reducing COPD exacerbations and exacerbation-related health care utilization.\n Randomized, double-blind study.\n 26 Veterans Affairs medical centers.\n 1829 patients with moderate to severe COPD (mean baseline FEV(1), 36% predicted).\n Once-daily tiotropium (18 microg) or placebo for 6 months. Patients otherwise received usual care, except for other anticholinergic bronchodilators.\n The coprimary end points were the percentage of patients with a COPD exacerbation and the percentage of patients with a COPD-related hospitalization.\n Tiotropium significantly reduced the percentage of patients experiencing 1 or more exacerbations compared with placebo (27.9% vs. 32.3%, respectively; difference, -5.7 percentage points [95% CI, -10.4 to -1.0 percentage points]; P = 0.037). Fewer tiotropium patients were hospitalized because of COPD exacerbation (7.0% vs. 9.5%, respectively; difference, -3.0 percentage points [CI, -5.9 to -0.1 percentage points]; P = 0.056), although this difference was of borderline statistical significance. Analysis of secondary outcomes indicates that tiotropium may lengthen the time to first COPD exacerbation (P = 0.028) and reduce health care utilization for exacerbations, including the frequency of hospitalizations (P = 0.047), unscheduled clinic visits (P = 0.019), and days of antibiotic treatment (P = 0.015). Tiotropium did not statistically significantly reduce all-cause hospitalization rates.\n Trial participants were enrolled from 1 health care system, and 99% were men. The follow-up period extended for only 6 months.\n Tiotropium reduces COPD exacerbations and may reduce related health care utilization in patients with moderate to severe COPD.", "Tiotropium (Spiriva; Ba679BR) is a new-generation, long-acting anticholinergic bronchodilator that has muscarinic M(1) and M(3) receptor subtype selectivity. A multicenter, randomized, double-blind, parallel group, placebo-controlled study was conducted to evaluate the dose-response characteristics of tiotropium inhalation powder given once daily to stable patients with chronic obstructive pulmonary disease (COPD). Patients (mean FEV(1) = 1.08 L [42% predicted]) were randomized to receive 0, 4.5, 9, 18, or 36 microg tiotropium once daily at noon for 4 wk, with spirometry done before and hourly for 6 h after dosing. Patients measured and recorded their peak expiratory flow rates (PEFRs) three times each day. Significant dose-related improvement in FEV(1) and significant improvement in FVC occurred within 1 h after the first dose of tiotropium as compared with placebo. Over the 29 d of the study, all doses of tiotropium produced significant increases over placebo in trough (i.e., as measured spirometrically at 20 to 24 h after the previous dose and just before the next dose of tiotropium), peak, and 6-h postdose average FEV(1) and FVC, and in PEFR, without a significant difference among the different doses investigated. PEFR gradually returned to pretreatment baseline levels over a 3-wk evaluation period following the discontinuation of tiotropium. The overall safety profile for the tiotropium doses was similar to that for placebo. In summary, tiotropium was shown to be safe and effective in doses ranging from 4.5 to 36 microg delivered once daily. The improvements in spirometry with once-daily dosing confirm the long duration of action of tiotropium reported in single-dose studies, and its sustained improvement of spirometric measures over the 1 mo of testing in the study points to utility of tiotropium as a maintenance bronchodilator for patients with COPD. On the basis of the comparable bronchodilator response at doses from 9 to 36 microg, and advantages suggested by the safety profile at doses below 36 microg in this study, a dose of 18 microg once daily was selected for use in long-term studies of the safety and efficacy of tiotropium.", "A study was undertaken to evaluate and compare the efficacy and safety of tiotropium and ipratropium during long term treatment in patients with stable chronic obstructive pulmonary disease (COPD).\n 288 patients of mean (SD) age 65 (8) years and forced expiratory volume in one second (FEV(1)) 41 (12)% predicted participated in a 14 centre, double blind, double dummy, parallel group study and were randomised after a run in period of two weeks to receive either tiotropium 18 microg once daily from a dry powder inhaler (HandiHaler; two thirds of patients) or ipratropium 40 microg four times daily from a metered dose inhaler (one third of patients) for a period of 13 weeks. Outcome measures were lung function, daily records of peak expiratory flow (PEF), and the use of concomitant salbutamol. FEV(1) and forced vital capacity (FVC) were measured one hour before and immediately before inhalation (mean value of the two measurements on test day 1 was the baseline value while on all other test days it was known as the trough FEV(1) and FVC), and 0.5, 1, 2, 3, 4, 5, and 6 hours after inhalation of the study drug on days 1, 8, 50, and 92.\n During treatment tiotropium achieved a significantly greater improvement than ipratropium (p<0.05) in trough, average, and peak FEV(1) levels and in trough and average FVC levels. The trough FEV(1) response on days 8, 50, and 92 ranged between 0.15 l (95% CI 0.11 to 0.19) and 0.16 l (95% CI 0.12 to 0.20) for tiotropium and between 0.01 l (95% CI -0.03 to 0.05) and 0.03 l (95% CI 0.01 to 0. 07) for ipratropium. The trough FVC response on days 8, 50, and 92 ranged between 0.34 l (95% CI 0.28 to 0.40) and 0.39 l (95% CI 0.31 to 0.47) for tiotropium and between 0.08 l (95% CI 0.00 to 0.16) and 0.18 l (95% CI 0.08 to 0.28) for ipratropium. On all test days tiotropium produced a greater improvement in FEV(1) than ipratropium starting three hours after inhalation (p<0.05). During treatment weekly mean morning and evening peak expiratory flow (PEF) was consistently better in the tiotropium group than in the ipratropium group, the difference in morning PEF being significant up through week 10 and in evening PEF up through week 7 of treatment (p<0.05). The use of concomitant salbutamol was also lower in the tiotropium group (p<0.05). The only drug related adverse event was dry mouth (tiotropium 14.7%, ipratropium 10.3% of patients).\n Tiotropium in a dose of 18 microg inhaled once daily using the HandiHaler was significantly more effective than 40 microg ipratropium four times daily in improving trough, average, and peak lung function over the 13 week period. The safety profile of tiotropium was similar to ipratropium. These data support the use of tiotropium as first line treatment for the long term maintenance treatment of patients with airflow obstruction due to COPD." ]

[ "8175269" ]

[ "The electrified drain. A new device for sterilizing the field of drainage." ]

[ "A randomized control study was performed on 24 patients to evaluate the effect of a new drainage system. Two types of drains were used: electrified and the conventional corrugated rubber drains. All of the 24 patients had an incisional hernia repair operation. In 12 patients, the wound was drained with an electrified drain (ED) and in the other 12 by the conventional drain (CD). The ED consisted of a corrugated rubber drain to which 2 silver-silver chloride electrodes were fixed. The wounds were drained for the first 3 post-operative days during which antibiotics were given. A peroperative and daily swab from the wound was taken during the time of drainage and for 4 days thereafter, and cultured. For evaluation, a pathogen count of less than 10(5) colony-forming units per ml of discharge from wound cultures was considered as successful drainage, while counts above this level were defined as failures. Drainage failure occurred in 4/12 patients (33%) of the CD group. Pathogens encountered were Streptococcus pyogenes, Staphylococcus aureus and albus and P. aeruginosa. Manifestations of wound inflammation occurred in 2 of the 4 patients. The appropriate antibiotic was given to the 4 patients after culture and sensitivity tests were performed. Drainage failure did not occur in any of the ED group. Post-operative laboratory assessment of blood count, liver and kidney functions and serum electrolytes recorded insignificant changes against preoperative values in both groups. The results demonstrate the superiority of the ED over the CD. The electric field produced by the ED seems to be lethal to organisms. The ED is simple, safe and cost-effective." ]

[ "17014550", "11497156", "18542921" ]

[ "Serum IL-6 and IL-1-ra with sequential organ failure assessment scores in septic patients receiving high-volume haemofiltration and continuous venovenous haemofiltration.", "High-volume haemofiltration in human septic shock.", "A pilot randomized study comparing high and low volume hemofiltration on vasopressor use in septic shock." ]

[ "Sepsis is characterized by an uncontrolled release of pro-inflammatory and anti-inflammatory mediators leading to immunoparalysis, cellular and humoral dysfunction, multiorgan dysfunction and death. This study evaluated the efficacy of high-volume haemofiltration (HVHF) compared with continuous venovenous haemofiltration (CVVH) in removing these inflammatory mediators. Clinical responses were assessed with the sequential organ failure assessment (SOFA) score.\n Septic patients with an end-organ dysfunction or septic shock were randomized to receive 6 h of CVVH (ultrafiltration dose of 2 L/h equivalent to about 35 mL/kg per hour or HVHF (ultrafiltration dose of 100 mL/kg per hour or 6 L/h, whichever was higher). The sequential organ failures were scored for the 24 hours preceding recruitment; at day 1, day 7, at discharge from the intensive care unit and at hospital discharge.\n Thirty-three patients were enrolled. Fifteen received HVHF and 18 received CVVH. The serum IL-6 levels (pg/mL) at baseline were similarly elevated in both groups (P = 0.745). The HVHF group showed a significant reduction after 6 h of treatment with a median interquartile range (IQR) of 20.62 (49.21) pg/mL (P = 0.025) with no similar result in the CVVH group. Non-survivors showed a higher baseline serum IL-6 compared with the survivors (median (IQR) 172.31 (261.34) vs 58.9 (104.21), P = 0.044). In the HVHF group there was a positive association between the IL-6 levels at 6 h with the SOFA scores at day 1 (r = 0.392, P = 0.001) but not at day 7. After 6 h of treatment in the HVHF group there was a direct correlation between the IL-6 levels and number of hospital days (r = 0.90, P = 0.040). The maximum SOFA scores were persistently recorded before treatment. The SOFA scores reduced in both groups from baseline to day 7 (HVHF P = 0.048; CVVH P = 0.006). The SOFA scores at day 1 is significantly higher in the non-survivors compared with the survivors (P = 0.038).\n High-volume haemofiltration at 6 L/h may seem to successfully remove some inflammatory cytokines in septic patients. The improvement in the SOFA scores at day 7 promises benefit of continuous renal replacement therapy in septic patients, but after 20 days this effect may be lost. In addition, the baseline serum IL-6 and IL-1-ra were independent predictors of a poor outcome as reflected by the higher SOFA scores at day 1.", "To evaluate whether high volume haemofiltration improves haemodynamics and affects serum cytokine and complement concentrations in human septic shock.\n Randomized cross-over clinical trial in a tertiary intensive care unit.\n Eleven patients with septic shock and multi-organ failure.\n Patients were assigned to either 8 h of high-volume haemofiltration (HVHF; 6 l/h) or 8 h of standard continuous veno-venous haemofiltration (CVVH; 1 l/h) in random order.\n We measured changes in haemodynamic variables, dose of norepinephrine required to maintain a mean arterial pressure greater than 70 mmHg and plasma concentrations of complement anaphylatoxins and several cytokines. An 8-h period of HVHF was associated with a greater reduction in norepinephrine requirements than a similar period of CVVH (median reduction: 10.5 vs. 1.0 microg/min; p = 0.01; median percentage reduction: 68 vs. 7%; p = 0.02). Both therapies were associated with a temporary reduction (p < 0.01) in the plasma concentration of C3a, C5a, and interleukin 10 within 2 h of initiation. HVHF was associated with a greater reduction in the area under the curve for C3a and C5a (p < 0.01). The concentration of the measured soluble mediators in the ultrafiltrate was negligible.\n HVHF decreases vasopressor requirements in human septic shock and affects anaphylatoxin levels differently than standard CVVH.", "High volume hemofiltration (HVHF) has shown potential benefits in septic animals and a few reports suggested a hemodynamic improvement in humans. However, randomized studies are still lacking. Our goal was to evaluate the hemodynamic effects of HVHF in septic shock patients with acute renal failure (ARF).\n Prospective randomized study in an intensive care unit (ICU).\n Twenty patients with septic shock and ARF.\n Patients were randomized to either high volume hemofiltration [HVHF 65 ml/(kg h)] or low volume hemofiltration [LVHF 35 ml/(kg h). Vasopressor dose was adjusted to reach a mean arterial pressure (MAP) > 65 mmHg.\n We performed six hourly measurements of MAP, norepinephrine dose, PaO(2)/FiO(2) and lactate, and four daily urine output and logistic organ dysfunction (LOD) score. Baseline characteristics of the two groups were comparable on randomization. Mean norepinephrine dose decreased more rapidly after 24 h of HVHF treatment compared to LVHF treatment (P = 0.004) whereas lactate and PaO(2)/FiO(2) did not differ between the two treatment groups. During the 4-day follow-up, urine output was slightly increased in the HVHF group (P = 0.059) but the LOD score evolution was not different. Duration of mechanical ventilation, renal replacement therapy and ICU length of stay were also comparable. Survival on day 28 was not affected.\n HVHF decreased vasopressor requirement and tended to increase urine output in septic shock patients with renal failure. However, a larger trial is required to confirm our results and perhaps to show a benefit in survival." ]

[ "10571715", "1873454", "11817917", "16580189", "22269590", "20022836", "6426618", "18326503", "19524389", "2556540", "2405112", "16325899", "9426791", "21299294" ]

[ "Smoking cessation in primary care clinics.", "A randomized trial of smoking cessation interventions in general practice in Italy.", "Improved smoking cessation in smokers given ultrasound photographs of their own atherosclerotic plaques.", "Spirometry and smoking cessation advice in general practice: a randomised clinical trial.", "Impact of carotid plaque screening on smoking cessation and other cardiovascular risk factors: a randomized controlled trial.", "Efficacy of genotype notification to Japanese smokers on smoking cessation--an intervention study at workplace.", "Controlled trial of three different antismoking interventions in general practice.", "Effect on smoking quit rate of telling patients their lung age: the Step2quit randomised controlled trial.", "Impact of a brief motivational smoking cessation intervention the Get PHIT randomized controlled trial.", "Randomized controlled trial of anti-smoking advice by nurses in general practice.", "Adding spirometry, carbon monoxide, and pulmonary symptom results to smoking cessation counseling: a randomized trial.", "An intervention study of smoking cessation with feedback on genetic cancer susceptibility in Japan.", "Genetic susceptibility testing in smoking-cessation treatment: one-year outcomes of a randomized trial.", "A randomized, controlled trial of adding expired carbon monoxide feedback to brief stop smoking advice: evaluation of cognitive and behavioral effects." ]

[ "To document smoking cessation rates achieved by applying the 1996 Agency for Health Care Policy and Research (AHCPR) smoking cessation guidelines for primary care clinics, compare these quit rates with historical results, and determine if quit rates improve with an additional motivational intervention that includes education as well as spirometry and carbon monoxide measurements.\n Randomized clinical trial.\n Two university-affiliated community primary care clinics.\n Two hundred five smokers with routinely scheduled appointments.\n All smokers were given advice and support according to AHCPR guidelines. Half of the subjects received additional education with spirometry and carbon monoxide measurements.\n Quit rate was evaluated at 9-month follow-up. Eleven percent of smokers were sustained quitters at follow-up. Sustained quit rate was no different for intervention and control groups (9% vs 14%; [OR] 0.6; 95% [CI] 0.2, 1.4). Nicotine replacement therapy was strongly associated with sustained cessation (OR 6.7; 95% CI 2.3, 19.6). Subjects without insurance were the least likely to use nicotine replacement therapy ( p =.05). Historical data from previously published studies showed that 2% of smokers quit following physician advice, and additional support similar to AHCPR guidelines increased the quit rate to 5%.\n The sustained smoking cessation rate achieved by following AHCPR guidelines was 11% at 9 months, which compares favorably with historical results. Additional education with spirometry did not improve the quit rate. Nicotine replacement therapy was the strongest predictor of cessation, yet was used infrequently owing to cost. These findings support the use of AHCPR guidelines in primary care clinics, but do not support routine spirometry for motivating patients similar to those studied here.", "The purpose of this study was to examine the effectiveness of different practice-based approaches to assist patients of primary care physicians to quit smoking and sustain cessation. Forty-four nonsmoking general practitioners volunteered for the study. After a period of training, they randomized 923 smoking clients, unselected for motivation toward quitting, to four different intervention groups: (i) minimal intervention, consisting of one single counselling session and a brief handout on quitting techniques; (ii) repeated counselling including reinforcing sessions at Months 1, 3, 6, and 9; (iii) repeated counselling and use of nicotine gum; and (iv) repeated counselling and spirometry. Biochemically validated smoking status was assessed at six and 12 months after recruitment. The proportion of verified quitters at 12 months was 4.8 percent among subjects randomized to the minimal intervention group, compared to 5.5 percent, 7.5 percent, and 6.5 percent among those randomized to the three repeated-counselling groups. In no treatment group was the outcome significantly different from that for one-time counselling at the (P less than 0.05) level. Lack of power, contamination, and low attendance at reinforcing sessions should be taken into account in interpreting the results.", "We examined whether making smokers aware that they had developed peripheral atherosclerosis would improve smoking cessation.\n Smokers selected from the general population were randomly allocated to undergo high-resolution B-mode ultrasonography of their carotid and femoral arteries. All smokers received quit-smoking counseling. Smokers with > or =1 atherosclerotic plaque were given two photographs of a plaque with a relevant explanation. Quit rates were assessed by telephone 6 months later.\n Seventy-nine smokers did not undergo ultrasonography (A). Among the 74 smokers submitted to ultrasonography, 20 had no plaque (B) and 54 had > or =1 plaque (C). Quit rates were, respectively, 6.3, 5.0, and 22.2% in groups A, B, and C. Quit rates were higher in smokers submitted to ultrasonography (B + C vs A; P = 0.031) and in those receiving photographs (C vs A + B; P = 0.003). Smoking cessation was independently associated with intervention C (OR = 6.2; 95% CI = 1.8-21) and a white-collar job but not with age or gender.\n Providing smokers with photographs demonstrating atherosclerosis on their own person was an effective adjunct to physician's advice to quit smoking. Since ultrasonography is used increasingly often in clinical practice for cardiovascular risk stratification, this can provide an additional opportunity and means to deter smokers from smoking.\n Copyright 2002 American Health Foundation and Elsevier Science (USA).", "To assess the success rate of smoking cessation with the \"minimal intervention strategy\" in general practice, and to determine the influence of spirometry on this success rate.\n Training in smoking cessation advice was given to 16 general practitioners (GPs). During 12 weeks, these GPs screened their practice population for smoking habits, the degree of dependence on nicotine, and the motivation to quit smoking. Patients willing to stop were randomised to a group that underwent a single office spirometry, or to a control group. The GPs were asked to support the attempts with the minimal intervention strategy. Success rates were compared after 6, 12 and 24 months.\n On a population of 5590 patients, 1206 smokers were identified (22%). To the vulnerable group, identified following the Prochaska and Di Clemente scheme, the proposal was made to change smoking behaviour. Two hundred and twenty-one patients undertook an attempt of smoking cessation. Nicotine replacement therapy (NRT) or bupropion was prescribed in 51% of the attempts. Sixty-four sustained quitters were counted after 6 months (29%), 43 after 1 year (19%) and 33 after 2 years (15%). We found a small but statistically non-significant difference in success rate in favour of the group that underwent office spirometry.\n GPs can motivate almost 20% of their smoking population to quit smoking. The success rate with the minimal intervention strategy was 19% after 1 year and 15% after 2 years. We found no arguments in favour of confronting smokers with their lung function as a tool for enhancing smoking cessation.", "Screening of peripheral atherosclerosis is increasingly used, but few trials have examined its clinical impact. We aimed to assess whether carotid plaque screening helps smokers to improve their health behaviors and cardiovascular risk factors.\n We randomly assigned 536 smokers aged 40 to 70 years to carotid plaque ultrasonographic screening (US group) vs no screening (control group) in addition to individual counseling and nicotine replacement therapy for all participants. Smokers with at least 1 plaque received pictures of their plaques with a 7-minute structured explanation. The outcomes included biochemically validated smoking cessation at 12 months (primary outcome) and changes in cardiovascular risk factor levels and Framingham risk score.\n At baseline, participants (mean age, 51.1 years; 45.0% women) smoked an average of 20 cigarettes per day with a median duration of 32 years. The US group had a high prevalence of carotid plaques (57.9%). At 12 months, smoking cessation rates were high, but did not differ between the US and control groups (24.9% vs 22.1%; P = .45). In the US group, cessation rates did not differ according to the presence or absence of plaques. Control of cardiovascular risk factors (ie, blood pressure and low-density lipoprotein cholesterol and hemoglobin A(1c) levels in diabetic patients) and mean absolute risk change in Framingham risk score did not differ between the groups. The mean absolute risk change in Framingham risk score was +0.6 in the US group vs +0.3 in the control group (P = .56).\n In smokers, carotid plaque screening performed in addition to thorough smoking cessation counseling is not associated with increased rates of smoking cessation or control of cardiovascular risk factors. Trial Registration  clinicaltrials.gov Identifier: NCT00548665.", "It is well-known that smoking causes many diseases including cancers. Informing smokers of their genotypes associated with the vulnerability to the harms of smoking may be effective measures for smoking cessation. The present study examined the effects of genotype notification of an oncogene (L-myc) genotype to smokers on their behavior to quit smoking.\n Subjects were 562 employees of a bank who answered to be a smoker for a questionnaire used at annual health checkup at workplace from July to December 2002. Those enrolled on August, October, and December were allocated into the genotype notification group (intervention group), and the rest into the controls. Among 286 smokers allocated into the intervention group, 257 participants (89.9%) agreed to genotype testing. One year after the enrollment, a follow-up questionnaire survey was conducted for all smokers including controls.\n Those who stated to have quitted smoking were 22 (8.0%) among the 276 controls and 15 (5.8%) among the 257 genotype notified participants, providing that the odds ratio (OR) of cessation for the intervention was 0.64 (95% confidence interval, 0.32-1.28). No psychological problems associated with genotype notification were observed.\n The present study did not show positive effects of genotype notification on smoking cessation rate. To elevate the cessation rate, methods to explain and notify genotypes should be improved.", "Of 6052 adult patients who consulted their doctors in six Oxfordshire general practices between October 1980 and February 1981, 2110 (35%) were smokers. The smokers were allocated to one of four study groups--a control (non-intervention) group; a group that received verbal and written antismoking advice from the general practitioner; a group that received this advice and also a demonstration of exhaled carbon monoxide; and a group that received the advice plus the offer of further help from a health visitor. After one year 72% of smokers replied to a postal follow up questionnaire: 11% of the control group claimed to have stopped smoking compared with 15% in the group that received advice alone, 17% in the exhaled carbon monoxide group, and 13% in the health visitor group. Validation of these findings by assays of urinary concentrations of cotinine showed that between 24% and 40% of subjects may have misreported their smoking habits, but there was no indication that the rate of misreporting was higher in the intervention groups than in the control group. Giving advice routinely against smoking has a useful effect, and showing an immediate, personal, and potentially harmful consequence of smoking using a CO-oximeter may improve this, particularly in lower socioeconomic groups.", "To evaluate the impact of telling patients their estimated spirometric lung age as an incentive to quit smoking.\n Randomised controlled trial.\n Five general practices in Hertfordshire, England.\n 561 current smokers aged over 35.\n All participants were offered spirometric assessment of lung function. Participants in intervention group received their results in terms of \"lung age\" (the age of the average healthy individual who would perform similar to them on spirometry). Those in the control group received a raw figure for forced expiratory volume at one second (FEV1). Both groups were advised to quit and offered referral to local NHS smoking cessation services.\n The primary outcome measure was verified cessation of smoking by salivary cotinine testing 12 months after recruitment. Secondary outcomes were reported changes in daily consumption of cigarettes and identification of new diagnoses of chronic obstructive lung disease.\n Follow-up was 89%. Independently verified quit rates at 12 months in the intervention and control groups, respectively, were 13.6% and 6.4% (difference 7.2%, P=0.005, 95% confidence interval 2.2% to 12.1%; number needed to treat 14). People with worse spirometric lung age were no more likely to have quit than those with normal lung age in either group. Cost per successful quitter was estimated at 280 pounds sterling (366 euros, $556). A new diagnosis of obstructive lung disease was made in 17% in the intervention group and 14% in the control group; a total of 16% (89/561) of participants.\n Telling smokers their lung age significantly improves the likelihood of them quitting smoking, but the mechanism by which this intervention achieves its effect is unclear.\n National Research Register N0096173751.", "Few studies have rigorously evaluated whether providing biologically based health-risk feedback is more effective than standard interventions in increasing smokers' motivation to quit and their long-term abstinence.\n An RCT was conducted from 2005 to 2008. Data were analyzed in 2008.\n Smokers (N=536) were recruited from the community, regardless of their interest in quitting smoking.\n Smokers either received brief ( approximately 20 minutes), personally tailored counseling sessions based on their lung functioning, carbon monoxide (CO) exposure, and smoking-related health conditions, or they received generic smoking-risk information and personalized counseling about their diet, BMI, and physical activity. All were advised to quit smoking and were offered access to a free phone-counseling program.\n Treatment utilization and abstinence at 6 and 12 months post-intervention.\n Participants who received the experimental treatment demonstrated no greater motivation to quit, use of treatment services, or abstinence compared to controls at either follow-up assessment. In fact, controls reported greater motivation to quit at 12 months (M 3.42 vs 3.20, p=0.03), greater use of pharmacotherapy at 6 months (37.8% vs 28.0%, p=0.02), and greater 30-day point prevalent abstinence at 6 months, after controlling for relevant covariates (10.8% vs 6.4%, adjusted p=0.04).\n The present study found no support for adding a personalized health-risk assessment emphasizing lung health and CO exposure to generic cessation advice and counseling for community-based smokers not otherwise seeking treatment.\n NCT00169260.", "Practice nurses are playing an increasingly prominent role in preventive care, including the provision of anti-smoking advice during routine health checks. A randomized controlled trial was designed to assess the effectiveness of anti-smoking advice provided by nurses in helping smokers to stop smoking. A total of 14,830 patients aged 16-65 years from 11 general practices completed a brief questionnaire on general health, including smoking status, at surgery attendance. The doctor identified 4330 smokers and randomly allocated 4210 to control or intervention groups. The doctor asked those in the intervention group to make an appointment with the practice nurse for a health check. The attendance rate at the health check was 26%. Smokers were sent follow-up questionnaires at one month and one year, and those who did not respond to two reminders were assumed to have continued to smoke. There was no significant difference in reported cessation between the intervention and control groups at one month or one year. However, there was a significant difference in the proportion of patients who reported giving up within one month and who had not lapsed by one year--0.9% in controls and 3.6% in the intervention group (P less than 0.01). Nevertheless, the effect of the nurse intervention itself may be small as the sustained cessation rate in attenders was only 42.4% higher than in non-attenders. The deception rate in reporting cessation, as measured by urinary cotinine, was of the order of 25%.", "Smokers are often advised to quit in a discussion of future health risks. The authors tested whether adding information about personal effects of smoking would motivate hospital outpatients to stop smoking more than advice about potential hazards would. Ninety smokers in a general screening clinic were randomized to receive education alone or education plus an additional motivational intervention that contained immediate feedback about the smoker's exhaled carbon monoxide (CO) values, spirometry results, and pulmonary symptoms. A self-report of smoking status was obtained one, four, and 12 months after the intervention. In addition, at 12 months, exhaled CO measurements were made. Smokers who received the additional motivational intervention were more than twice as likely to report quitting some time during the 12-month follow-up (40% vs. 16%, p = 0.015). At 12 months, 33% of the intervention group and 10% of the control group smokers tested had achieved CO-validated cessation (p = 0.03). Counting all patients not contacted as continuing to smoke, the percentages were 20% vs. 7% (p = 0.06). These practical feedback methods to motivate cessation deserve testing in other settings.", "To evaluate whether feedback of genetic information regarding an L-myc polymorphism, identified as impacting on tobacco-related cancer risk, has an influence on smoking cessation, an intervention study was conducted.\n We recruited smokers from first-visit outpatients at Aichi Cancer Center Hospital. Six hundred and seventeen participated and were allocated into two groups: the biomarker feedback group (BF) and the follow-up smoking status group (FS). The subjects were asked for their smoking status at enrolment and at 3- and 9-month follow-ups. BF subjects were notified about their L-myc genotype.\n The smoking cessation rate at 9-month follow-up was essentially the same for both BF and FS cases, at 18.8% and 17.0%, respectively (P = 0.798). However, a difference in the rate was evident with non-cancer subjects (12.7% and 8.4%, respectively, P = 0.237), especially in females (15.0% and 4.2%, respectively, P = 0.024). The non-cancer subjects informed of their genotype were more likely to quit smoking than the FS patients; particularly in those having a risky genotype, this was significant (odds ratio: 2.87, P = 0.003). Again it was most prominent in females.\n Feedback regarding an L-myc polymorphism did not impact on smoking cessation overall but appeared to benefit smokers without cancer. In addition, gender could affect the response to the feedback.", "This study evaluated the long-term impact of genetic susceptibility biomarker feedback on smoking behavior change and symptoms of depression in 426 male and female smokers. Smokers were randomized to one of three smoking-cessation interventions: minimal contact quit-smoking counseling (QSC), QSC + exposure biomarker feedback (EBF), and QSC + EBF + biomarker feedback about genetic susceptibility to lung cancer (SBF). The logistic regression model for quit attempt revealed a significant main effect for treatment such that participants in the SBF group were more than two times more likely to make a quit attempt than participants in the QSC group. There was not a significant difference between EBF and QSC participants. The results also revealed a significant effect for baseline stage of change. Those smokers in the preparation stage at baseline were more than three times more likely to make a quit attempt over the 12 months following treatment. The models for 30-day cessation and follow-up smoking rate revealed no significant main or interacting effects for treatment. A repeated measures analysis of variance revealed a significant main effect for time, indicating that an initial increase in depression in the genetic susceptibility group was not maintained over time. Genetic susceptibility feedback has the intended effects on motivation to quit, but it may need to be delivered within a more intensive smoking-cessation treatment for the heightened motivation to translate into smoking cessation.", "To determine the effect of adding biomarker feedback (expired air carbon monoxide) to standard quit advice on cognitive antecedents of behavior change and smoking cessation and to identify potential effect moderators and mediators.\n Smokers (N = 160) were randomized to a control (quit advice plus leaflet) or an intervention condition (as control group plus carbon-monoxide level feedback). Cognitive measures were assessed immediately after the intervention and behavioral measures at 6 months' follow-up.\n Primary outcome measures were threat and efficacy appraisal, fear arousal, and intention to stop smoking. Secondary outcome measures were quit attempts within the last 6 months and 7-day point prevalence abstinence.\n Threat appraisal was significantly enhanced in the intervention compared with the control group, t(158) = 2.29, p = .023, as was intention to stop smoking in the next month, t(151) = 2.9, p = .004. However, this effect on intention to stop smoking was short-lived. Groups did not differ in terms of quit attempts or abstinence at follow-up, but the intervention increased the likelihood of cessation in smokers with higher self-efficacy, χ2(1) = 5.82, p = .016.\n Carbon-monoxide level feedback enhances the effect of brief quit advice on cognitive antecedents of behavior change and smoking cessation rates but further research is required to confirm the longevity of this effect and its applicability to smokers with low self-efficacy.\n (PsycINFO Database Record (c) 2010 APA, all rights reserved)." ]

[ "1860198", "2233931", "1856403", "1406859", "2563096" ]

[ "Stroke Prevention in Atrial Fibrillation Study. Final results.", "The effect of low-dose warfarin on the risk of stroke in patients with nonrheumatic atrial fibrillation. The Boston Area Anticoagulation Trial for Atrial Fibrillation Investigators.", "Canadian Atrial Fibrillation Anticoagulation (CAFA) Study.", "Warfarin in the prevention of stroke associated with nonrheumatic atrial fibrillation. Veterans Affairs Stroke Prevention in Nonrheumatic Atrial Fibrillation Investigators.", "Placebo-controlled, randomised trial of warfarin and aspirin for prevention of thromboembolic complications in chronic atrial fibrillation. The Copenhagen AFASAK study." ]

[ "Atrial fibrillation in the absence of rheumatic valvular disease is associated with a fivefold to sevenfold increased risk of ischemic stroke.\n The Stroke Prevention in Atrial Fibrillation Study, a multicenter, randomized trial, compared 325 mg/day aspirin (double-blind) or warfarin with placebo for prevention of ischemic stroke and systemic embolism (primary events), and included 1,330 inpatients and outpatients with constant or intermittent atrial fibrillation. During a mean follow-up of 1.3 years, the rate of primary events in patients assigned to placebo was 6.3% per year and was reduced by 42% in those assigned to aspirin (3.6% per year; p = 0.02; 95% confidence interval, 9-63%). In the subgroup of warfarin-eligible patients (most less than 76 years old), warfarin dose-adjusted to prolong prothrombin time to 1.3-fold to 1.8-fold that of control reduced the risk of primary events by 67% (warfarin versus placebo, 2.3% versus 7.4% per year; p = 0.01; 95% confidence interval, 27-85%). Primary events or death were reduced 58% (p = 0.01) by warfarin and 32% (p = 0.02) by aspirin. The risk of significant bleeding was 1.5%, 1.4%, and 1.6% per year in patients assigned to warfarin, aspirin, and placebo, respectively.\n Aspirin and warfarin are both effective in reducing ischemic stroke and systemic embolism in patients with atrial fibrillation. Because warfarin-eligible patients composed a subset of all aspirin-eligible patients, the magnitude of reduction in events by warfarin versus aspirin cannot be compared. Too few events occurred in warfarin-eligible patients to directly assess the relative benefit of aspirin compared with warfarin, and the trial is continuing to address this issue. Patients with nonrheumatic atrial fibrillation who can safely take either aspirin or warfarin should receive prophylactic antithrombotic therapy to reduce the risk of stroke.", "Nonrheumatic atrial fibrillation increases the risk of stroke, presumably from atrial thromboemboli. There is uncertainty about the efficacy and risks of long-term warfarin therapy to prevent stroke.\n We conducted an unblinded, randomized, controlled trial of long-term, low-dose warfarin therapy (target prothrombin-time ratio, 1.2 to 1.5) in patients with nonrheumatic atrial fibrillation. The control group was not given warfarin but could choose to take aspirin.\n A total of 420 patients entered the trial (212 in the warfarin group and 208 in the control group) and were followed for an average of 2.2 years. Prothrombin times in the warfarin group were in the target range 83 percent of the time. Only 10 percent of the patients assigned to receive warfarin discontinued the drug permanently. There were 2 strokes in the warfarin group (incidence, 0.41 percent per year) as compared with 13 strokes in the control group (incidence, 2.98 percent per year), for a reduction of 86 percent in the risk of stroke (warfarin:control incidence ratio = 0.14; 95 percent confidence interval, 0.04 to 0.49; P = 0.0022). There were 37 deaths altogether. The death rate was markedly lower in the warfarin group than in the control group: 2.25 percent as compared with 5.97 percent per year, for an incidence ratio of 0.38 (95 percent confidence interval, 0.17 to 0.82; P = 0.005). There was one fatal hemorrhage in each group. The frequency of bleeding events that led to hospitalization or transfusion was essentially the same in both groups. The warfarin group had a higher rate of minor hemorrhage than the control group (38 vs. 21 patients).\n Long-term low-dose warfarin therapy is highly effective in preventing stroke in patients with non-rheumatic atrial fibrillation, and can be quite safe with careful monitoring.", "The Canadian Atrial Fibrillation Anticoagulation Study was a randomized double-blind placebo-controlled trial to assess the potential of warfarin to reduce systemic thromboembolism and its inherent risk of hemorrhage. As a result of the publication of two other \"positive\" studies of similar design and objective, this study was stopped early before completion of its planned recruitment of 630 patients. There were 187 patients randomized to warfarin and 191 to placebo. Permanent discontinuation of study medication occurred in 26% of warfarin-treated and 23% of placebo-treated patients. The target range of the international normalized ratio was 2 to 3. For the warfarin-treated patients, the international normalized ratio was in the target range 43.7% of the study days, above it 16.6% of the study days and below it 39.6% of the study days. Fatal or major bleeding occurred at annual rates of 2.5% in warfarin-treated and 0.5% in placebo-treated patients. Minor bleeding occurred in 16% of patients receiving warfarin and 9% receiving placebo. The primary outcome event cluster was nonlacunar stroke, noncentral nervous systemic embolism and fatal or intracranial hemorrhage. Events were included in the primary analysis of efficacy if they occurred within 28 days of permanent discontinuation of the study medication. The annual rates of the primary outcome event cluster were 3.5% in warfarin-treated and 5.2% in placebo-treated patients, with a relative risk reduction of 37% (95% confidence limits, -63.5%, 75.5%, p = 0.17).(ABSTRACT TRUNCATED AT 250 WORDS)", "Nonrheumatic atrial fibrillation is common among the elderly and is associated with an increased risk of stroke. We investigated whether anticoagulation with warfarin would reduce this risk.\n We conducted a randomized, double-blind, placebo-controlled study to evaluate low-intensity anticoagulation with warfarin (prothrombin-time ratio, 1.2 to 1.5) in 571 men with chronic nonrheumatic atrial fibrillation; 525 patients had not previously had a cerebral infarction, whereas 46 patients had previously had such an event. The primary end point was cerebral infarction; secondary end points were cerebral hemorrhage and death.\n Among the patients with no history of stroke, cerebral infarction occurred in 19 of the 265 patients in the placebo group during an average follow-up of 1.7 years (4.3 percent per year) and in 4 of the 260 patients in the warfarin group during an average follow-up of 1.8 years (0.9 percent per year). The reduction in risk with warfarin therapy was 0.79 (95 percent confidence interval, 0.52 to 0.90; P = 0.001). The annual event rate among the 228 patients over 70 years of age was 4.8 percent in the placebo group and 0.9 percent in the warfarin group (risk reduction, 0.79; P = 0.02). The only cerebral hemorrhage occurred in a 73-year-old patient in the warfarin group. Other major hemorrhages, all gastrointestinal, occurred in 10 patients: 4 in the placebo group, for a rate of 0.9 percent per year, and 6 in the warfarin group, for a rate of 1.3 percent per year. There were 37 deaths that were not preceded by a cerebral end point--22 in the placebo group and 15 in the warfarin group (risk reduction, 0.31; P = 0.19). Cerebral infarction was more common among patients with a history of cerebral infarction (9.3 percent per year in the placebo group and 6.1 percent per year in the warfarin group) than among those without such a history.\n Low-intensity anticoagulation with warfarin prevented cerebral infarction in patients with nonrheumatic atrial fibrillation without producing an excess risk of major hemorrhage. This benefit extended to patients over 70 years of age.", "From November, 1985, to June, 1988, 1007 outpatients with chronic non-rheumatic atrial fibrillation (AF) entered a randomised trial; 335 received anticoagulation with warfarin openly, and in a double-blind study 336 received aspirin 75 mg once daily and 336 placebo. Each patient was followed up for 2 years or until termination of the trial. The primary endpoint was a thromboembolic complication (stroke, transient cerebral ischaemic attack, or embolic complications to the viscera and extremities). The secondary endpoint was death. The incidence of thromboembolic complications and vascular mortality were significantly lower in the warfarin group than in the aspirin and placebo groups, which did not differ significantly. 5 patients on warfarin had thromboembolic complications compared with 20 patients on aspirin and 21 on placebo. 21 patients on warfarin were withdrawn because of non-fatal bleeding complications compared with 2 on aspirin and none on placebo. Thus, anticoagulation therapy with warfarin can be recommended to prevent thromboembolic complications in patients with chronic non-rheumatic AF." ]

[ "20819780", "20498403", "15681523", "21429799", "18160686", "21383283", "21990397" ]

[ "First-line bevacizumab plus taxane-based chemotherapy for locally recurrent or metastatic breast cancer: safety and efficacy in an open-label study in 2,251 patients.", "Phase III study of bevacizumab plus docetaxel compared with placebo plus docetaxel for the first-line treatment of human epidermal growth factor receptor 2-negative metastatic breast cancer.", "Randomized phase III trial of capecitabine compared with bevacizumab plus capecitabine in patients with previously treated metastatic breast cancer.", "Motesanib, or open-label bevacizumab, in combination with paclitaxel, as first-line treatment for HER2-negative locally recurrent or metastatic breast cancer: a phase 2, randomised, double-blind, placebo-controlled study.", "Paclitaxel plus bevacizumab versus paclitaxel alone for metastatic breast cancer.", "RIBBON-1: randomized, double-blind, placebo-controlled, phase III trial of chemotherapy with or without bevacizumab for first-line treatment of human epidermal growth factor receptor 2-negative, locally recurrent or metastatic breast cancer.", "RIBBON-2: a randomized, double-blind, placebo-controlled, phase III trial evaluating the efficacy and safety of bevacizumab in combination with chemotherapy for second-line treatment of human epidermal growth factor receptor 2-negative metastatic breast cancer." ]

[ "First-line bevacizumab combined with chemotherapy significantly improves efficacy versus chemotherapy alone in human epidermal growth factor receptor 2 (HER2)-negative locally recurrent or metastatic breast cancer (LR/mBC). This large, open-label study further assesses first-line bevacizumab with taxane-based chemotherapy in routine oncology practice.\n Patients with HER2-negative LR/mBC, Eastern Cooperative Oncology Group (ECOG) performance status (PS) of zero to two and no prior chemotherapy for LR/mBC received bevacizumab 10 mg/kg every 2 weeks or 15 mg/kg every 3 weeks plus taxane-based chemotherapy (or other non-anthracycline chemotherapy) until disease progression, unacceptable toxicity or patient withdrawal. The primary end point was safety; time to progression (TtP) was a secondary end point.\n Median follow-up in 2251 treated patients was 12.7 months. Median age was 53 years and 94% of patients had ECOG PS of zero or one. Bevacizumab was most commonly administered with single-agent paclitaxel (35%), single-agent docetaxel (33%) or taxane-based combination therapy (10%). The most frequent grade ≥3 adverse event (AE) was neutropenia (5.4%). Grade ≥3 AEs previously associated with bevacizumab included hypertension (4.4%), arterial/venous thromboembolism (3.2%), proteinuria (1.7%) and bleeding (1.4%). No new bevacizumab safety signals were observed. Median TtP was 9.5 months (95% confidence interval 9.1-9.9).\n The study population in ATHENA was more representative of general oncology practice than populations enrolled into randomised trials, although there may have been some bias towards younger, fitter patients. The safety and efficacy of bevacizumab-taxane therapy in this large study were consistent with results from randomised first-line trials.", "The efficacy and safety of combining bevacizumab (7.5 and 15 mg/kg) with docetaxel as first-line therapy for human epidermal growth factor receptor 2 (HER2) -negative, locally recurrent or metastatic breast cancer (MBC) was investigated in a three-arm, placebo-controlled, phase III trial.\n Patients (N = 736) were randomly assigned to docetaxel 100 mg/m(2) plus either placebo or bevacizumab 7.5 or 15 mg/kg every 3 weeks. The primary end point was progression-free survival (PFS); secondary end points included best overall response, duration of response, time to treatment failure, overall survival, and safety.\n Combination of bevacizumab 15 mg/kg, but not 7.5 mg/kg, with docetaxel showed superior median PFS (mPFS) to placebo plus docetaxel in unstratified analysis (placebo mPFS, 8.2 months; 7.5 mg/kg mPFS, 9.0 months [hazard ratio (HR), 0.86; P = .12]; 15 mg/kg mPFS, 10.1 months [HR, 0.77; P = .006]) and stratified analysis (placebo mPFS, 8.1 months; 7.5 mg/kg mPFS, 9.0 months [HR, 0.80; P = .045]; 15 mg/kg mPFS, 10.0 months [HR, 0.67; P < .001]). Response rates in patients with measurable disease at baseline also increased with bevacizumab 15 mg/kg (46% [placebo] v 55% [7.5 mg/kg; P = .07] and 64% [15 mg/kg; P < .001]). Combination with bevacizumab had limited impact on the known toxicity profile of docetaxel.\n Combination of bevacizumab with docetaxel did not significantly impact on the safety profile of docetaxel. Bevacizumab 15 mg/kg every 3 weeks significantly increased PFS when combined with docetaxel as first-line therapy for MBC compared with docetaxel plus placebo.", "This randomized phase III trial compared the efficacy and safety of capecitabine with or without bevacizumab, a monoclonal antibody to vascular endothelial growth factor, in patients with metastatic breast cancer previously treated with an anthracycline and a taxane.\n Patients were randomly assigned to receive capecitabine (2,500 mg/m2/d) twice daily on day 1 through 14 every 3 weeks, alone or in combination with bevacizumab (15 mg/kg) on day 1. The primary end point was progression-free survival (PFS), as determined by an independent review facility.\n From November 2000 to March 2002, 462 patients were enrolled. Treatment arms were balanced. No significant differences were found in the incidence of diarrhea, hand-foot syndrome, thromboembolic events, or serious bleeding episodes between treatment groups. Of other grade 3 or 4 adverse events, only hypertension requiring treatment (17.9% v 0.5%) was more frequent in patients receiving bevacizumab. Combination therapy significantly increased the response rates (19.8% v 9.1%; P = .001); however, this did not result in a longer PFS (4.86 v 4.17 months; hazard ratio = 0.98). Overall survival (15.1 v 14.5 months) and time to deterioration in quality of life as measured by the Functional Assessment Of Cancer Treatment--Breast were comparable in both treatment groups.\n Bevacizumab was well tolerated in this heavily pretreated patient population. Although the addition of bevacizumab to capecitabine produced a significant increase in response rates, this did not translate into improved PFS or overall survival.", "Vascular endothelial growth factor (VEGF) has a crucial role in angiogenesis, and is a valid target in metastatic breast cancer. Motesanib is an investigational oral inhibitor of VEGF receptors. We aimed to determine whether treatment with motesanib plus paclitaxel is better than placebo plus paclitaxel in patients with HER2-negative locally recurrent or metastatic breast cancer.\n Between Dec 1, 2006, and July 4, 2008, patients with untreated HER2-negative metastatic breast cancer were randomly assigned (using a randomisation list created by personnel not associated with the study) in a 1:1:1 ratio to paclitaxel (90 mg/m(2) on days 1, 8, and 15 every 3 weeks) plus either masked motesanib 125 mg orally once per day (n=91), masked placebo orally once per day (n=94), or open-label bevacizumab 10 mg/kg intravenously on days 1 and 15 of each 28-day cycle (n=97), after stratification according to adjuvant or neoadjuvant chemotherapy (taxane-containing regimens vs other regimens vs none), number of metastatic sites (<3 vs ≥3), and hormone receptor status (positive vs negative). Placebo was provided as a replica of motesanib 25 mg tablets. The primary endpoint was objective response rate (ORR) based on the population as assigned to treatment. This trial is registered with ClinicalTrials.gov, number NCT00356681.\n ORRs for the motesanib group and the placebo group did not differ significantly (49%vs 41%; absolute difference 8% [95% CI -6 to 22]; p=0.31). The ORR in the bevacizumab group (52%) was similar to that in the motesanib group. The most common grade 3 or higher adverse events included diarrhoea (18 of 92 patients in the motesanib group, none of 89 patients in the placebo group, and four of 96 patients in the bevacizumab group), fatigue (11, eight, and six), hypertension (11, one, and seven), and peripheral sensory neuropathy (ten, seven, and 19). More patients in the motesanib group had serious adverse events than did those in the placebo or bevacizumab groups (34, 26, and 21 patients, respectively); the most common of these in the motesanib group were gastrointestinal in nature.\n Data from this trial do not support the further investigation of motesanib at this dose and schedule in this population.\n Amgen.\n Copyright © 2011 Elsevier Ltd. All rights reserved.", "In an open-label, randomized, phase 3 trial, we compared the efficacy and safety of paclitaxel with that of paclitaxel plus bevacizumab, a monoclonal antibody against vascular endothelial growth factor, as initial treatment for metastatic breast cancer.\n We randomly assigned patients to receive 90 mg of paclitaxel per square meter of body-surface area on days 1, 8, and 15 every 4 weeks, either alone or with 10 mg of bevacizumab per kilogram of body weight on days 1 and 15. The primary end point was progression-free survival; overall survival was a secondary end point.\n From December 2001 through May 2004, a total of 722 patients were enrolled. Paclitaxel plus bevacizumab significantly prolonged progression-free survival as compared with paclitaxel alone (median, 11.8 vs. 5.9 months; hazard ratio for progression, 0.60; P<0.001) and increased the objective response rate (36.9% vs. 21.2%, P<0.001). The overall survival rate, however, was similar in the two groups (median, 26.7 vs. 25.2 months; hazard ratio, 0.88; P=0.16). Grade 3 or 4 hypertension (14.8% vs. 0.0%, P<0.001), proteinuria (3.6% vs. 0.0%, P<0.001), headache (2.2% vs. 0.0%, P=0.008), and cerebrovascular ischemia (1.9% vs. 0.0%, P=0.02) were more frequent in patients receiving paclitaxel plus bevacizumab. Infection was more common in patients receiving paclitaxel plus bevacizumab (9.3% vs. 2.9%, P<0.001), but febrile neutropenia was uncommon (<1% overall).\n Initial therapy of metastatic breast cancer with paclitaxel plus bevacizumab prolongs progression-free survival, but not overall survival, as compared with paclitaxel alone. (ClinicalTrials.gov number, NCT00028990 [ClinicalTrials.gov].).\n Copyright 2007 Massachusetts Medical Society.", "This phase III study compared the efficacy and safety of bevacizumab (BV) when combined with several standard chemotherapy regimens versus those regimens alone for first-line treatment of patients with human epidermal growth factor receptor 2-negative metastatic breast cancer.\n Patients were randomly assigned in 2:1 ratio to chemotherapy plus BV or chemotherapy plus placebo. Before random assignment, investigators chose capecitabine (Cape; 2,000 mg/m(2) for 14 days), taxane (Tax) -based (nab-paclitaxel 260 mg/m(2), docetaxel 75 or 100 mg/m(2)), or anthracycline (Anthra) -based (doxorubicin or epirubicin combinations [doxorubicin/cyclophosphamide, epirubicin/cyclophosphamide, fluorouracil/epirubicin/cyclophosphamide, or fluorouracil/doxorubicin/cyclophosphamide]) chemotherapy administered every 3 weeks. BV or placebo was administered at 15 mg/kg every 3 weeks. The primary end point was progression-free survival (PFS). Secondary end points included overall survival (OS), 1-year survival rate, objective response rate, duration of objective response, and safety. Two independently powered cohorts defined by the choice of chemotherapy (Cape patients or pooled Tax/Anthra patients) were analyzed in parallel.\n RIBBON-1 (Regimens in Bevacizumab for Breast Oncology) enrolled 1,237 patients (Cape cohort, n = 615; Tax/Anthra cohort, n = 622). Median PFS was longer for each BV combination (Cape cohort: increased from 5.7 months to 8.6 months; hazard ratio [HR], 0.69; 95% CI, 0.56 to 0.84; log-rank P < .001; and Tax/Anthra cohort: increased from 8.0 months to 9.2 months; HR, 0.64; 95% CI, 0.52 to 0.80; log-rank P < .001). No statistically significant differences in OS between the placebo- and BV-containing arms were observed. Safety was consistent with results of prior BV trials.\n The combination of BV with Cape, Tax, or Anthra improves clinical benefit in terms of increased PFS in first-line treatment of metastatic breast cancer, with a safety profile comparable to prior phase III studies.", "This phase III study compared the efficacy and safety of bevacizumab combined with standard chemotherapy regimens versus chemotherapy alone as second-line treatment of patients with human epidermal growth factor receptor 2 (HER2) -negative metastatic breast cancer.\n Patients were randomly assigned 2:1 to chemotherapy + bevacizumab or to chemotherapy + placebo. Before random assignment, investigators chose capecitabine, a taxane (paclitaxel, nab-paclitaxel, or docetaxel), gemcitabine, or vinorelbine. Dosing for bevacizumab or placebo was 15 mg/kg every 3 weeks or 10 mg/kg every 2 weeks, depending on chemotherapy regimen. The primary end point was progression-free survival (PFS). Secondary end points included overall survival, PFS by chemotherapy cohort, objective response rate (ORR), duration of objective response, 1-year survival rate, and safety.\n RIBBON-2 enrolled 684 patients (225, chemotherapy + placebo; 459, chemotherapy + bevacizumab). The combination of bevacizumab with chemotherapy demonstrated a statistically significant benefit. Median PFS increased from 5.1 to 7.2 months (stratified hazard ratio for PFS, 0.78; 95% CI, 0.64 to 0.93; P = .0072). The 10% improvement in ORR between the placebo- and bevacizumab-containing arms (39.5% v 29.6%; P = .0193), although not statistically significant, was consistent with previous trials. There was no statistically significant difference in overall survival. The most common grade ≥ 3 adverse events (AEs) related to bevacizumab treatment were hypertension (9.0%) and proteinuria (3.1%). There was an increased number of AEs leading to study discontinuation in the chemotherapy + bevacizumab arm compared with the chemotherapy + placebo arm (13.3% v 7.2%).\n The combination of bevacizumab with commonly used chemotherapies improved PFS in the second-line treatment of patients with HER2-negative metastatic breast cancer, with a safety profile comparable with that in prior phase III studies." ]

[ "9761802", "9602199", "7728627" ]

[ "A comparison of active and simulated chiropractic manipulation as adjunctive treatment for childhood asthma.", "Children with asthma have improved pulmonary functions after massage therapy.", "Chronic asthma and chiropractic spinal manipulation: a randomized clinical trial." ]

[ "Chiropractic spinal manipulation has been reported to be of benefit in nonmusculoskeletal conditions, including asthma.\n We conducted a randomized, controlled trial of chiropractic spinal manipulation for children with mild or moderate asthma. After a three-week base-line evaluation period, 91 children who had continuing symptoms of asthma despite usual medical therapy were randomly assigned to receive either active or simulated chiropractic manipulation for four months. None had previously received chiropractic care. Each subject was treated by 1 of 11 participating chiropractors, selected by the family according to location. The primary outcome measure was the change from base line in the peak expiratory flow, measured in the morning, before the use of a bronchodilator, at two and four months. Except for the treating chiropractor and one investigator (who was not involved in assessing outcomes), all participants remained fully blinded to treatment assignment throughout the study.\n Eighty children (38 in the active-treatment group and 42 in the simulated-treatment group) had outcome data that could be evaluated. There were small increases (7 to 12 liters per minute) in peak expiratory flow in the morning and the evening in both treatment groups, with no significant differences between the groups in the degree of change from base line (morning peak expiratory flow, P=0.49 at two months and P=0.82 at four months). Symptoms of asthma and use of 3-agonists decreased and the quality of life increased in both groups, with no significant differences between the groups. There were no significant changes in spirometric measurements or airway responsiveness.\n In children with mild or moderate asthma, the addition of chiropractic spinal manipulation to usual medical care provided no benefit.", "Thirty-two children with asthma (16 4- to 8-year-olds and 16 9- to 14-year-olds) were randomly assigned to receive either massage therapy or relaxation therapy. The children's parents were taught to provide one therapy or the other for 20 minutes before bedtime each night for 30 days. The younger children who received massage therapy showed an immediate decrease in behavioral anxiety and cortisol levels after massage. Also, their attitude toward asthma and their peak air flow and other pulmonary functions improved over the course of the study. The older children who received massage therapy reported lower anxiety after the massage. Their attitude toward asthma also improved over the study, but only one measure of pulmonary function (forced expiratory flow 25% to 75%) improved. The reason for the smaller therapeutic benefit in the older children is unknown; however, it appears that daily massage improves airway caliber and control of asthma.", "The purpose of this randomized patient- and observer-blinded cross-over trial was to evaluate the efficacy of chiropractic treatment in the management of chronic asthma when combined with pharmaceutical maintenance therapy. The trial was conducted at the National University Hospital's Out-patient Clinic in Copenhagen, Denmark. Thirty-one patients aged 18-44 years participated, all suffering from chronic asthma controlled by bronchodilators and/or inhaled steroids. Patients, or who had received chiropractic treatment for asthma within the last 5 years, who received oral steroids and immunotherapy, were not eligible. Patients were randomized to receive either active chiropractic spinal manipulative treatment or sham chiropractic spinal manipulative treatment twice weekly for 4 weeks, and then crossed over to the alternative treatment for another 4 weeks. Both phases were preceded and followed by a 2-week period without chiropractic treatment. The main outcome measurements were forced expiratory volume in the first second (FEV1), forced vital capacity (FVC), daily use of inhaled bronchodilators, patient-rated asthma severity and non-specific bronchial reactivity (n-BR). Using the cross-over analysis, no clinically important or statistically significant differences were found between the active and sham chiropractic interventions on any of the main or secondary outcome measures. Objective lung function did not change during the study, but over the course of the study, non-specific bronchial hyperreactivity (n-BR) improved by 36% (P = 0.01) and patient-rated asthma severity decreased by 34% (P = 0.0002) compared with the baseline values.(ABSTRACT TRUNCATED AT 250 WORDS)" ]