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Results for “Randomized trial”

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At least 325 records · Page 18Linked to original sources

PubMed2001

Electrical muscle stimulation as an adjunct to exercise therapy in the treatment of nonacute low back pain: a randomized trial.

A prospective, randomized, double-blind, placebo-controlled clinical trial was performed to investigate the efficacy of electrical muscle stimulation when combined with a therapist-guided, standardized exercise therapy program in the treatment of nonacute low back pain. Eighty patients with low back pain of at least 6 weeks' duration were randomized into the following 2 groups: standardized exercise therapy with functional electrical muscle stimulation or standardized exercise therapy with placebo electrical stimulation. Subjects were evaluated at baseline, 2 months, and 6 months with a standardized back pain questionnaire and objective measurements of lumbar spine function. Exercise therapy was continued for 6 months, but electrical stimulation was discontinued at the 2-month interval. Of the 80 patients initially enrolled, 42 discontinued or withdrew before completing the entire study protocol. At the 2-month follow-up interval, subjects in the treatment group had statistically significantly improved lumbar spine function compared with the control subjects. This effect continued during the last 4 months of the study after electrical stimulation had been discontinued. This suggests that electrical muscle stimulation can be an effective adjunctive treatment modality for nonacute low back pain. The effects of this combined therapy seem to last beyond the duration of electrical stimulation treatment.

Clinical Trial↗

PubMed2006

The Rhythm ID Going Head to Head Trial (RIGHT): design of a randomized trial comparing competitive rhythm discrimination algorithms in implantable cardioverter defibrillators.

BACKGROUND: The implantable cardioverter defibrillator (ICD) has become primary therapy for the prevention of sudden death. One of the major morbidities of ICD use remains inappropriate therapy for supraventricular arrhythmias (SVA). Detection enhancements have increased therapy specificity, but their impact on inappropriate therapy is not well studied. Moreover, ICD manufacturers have developed unique algorithms to meet this goal, with no previous clinical direct comparisons. RIGHT is a randomized, prospective study that will assess the differential efficacy of ICDs from two different manufacturers. It is the first trial to compare directly competitive ICD rhythm discrimination algorithms on a large scale. OBJECTIVE: The primary objective of this study is to assess arrhythmia discrimination in Guidant versus Medtronic ICDs by comparing the time to first inappropriate therapy after the predischarge visit. METHODS: The study will enroll approximately 2,000 patients in 100 centers. Patients will be randomized to Guidant or Medtronic using a permuted block design, stratified by center and by single/dual chamber device types. Patients will receive a commercially available Guidant VITALITY 2 family ICD with Rhythm ID or a Medtronic ICD using the Enhanced PR Logic or Wavelet discrimination algorithms, and will be followed according to the schedule shown until a common closing date with a minimum follow-up of 12 months. All events will be reviewed by an independent committee to determine the appropriateness of rhythm classification and therapy delivery. CONCLUSION: RIGHT is the first randomized, large scale, head-to-head comparison of ICD discrimination algorithms.

Algorithms↗

PubMed2003

Semimonthly versus monthly regimen of fluorouracil and leucovorin administered for 24 or 36 weeks as adjuvant therapy in stage II and III colon cancer: results of a randomized trial.

PURPOSE: This randomized, 2 x 2 factorial study compared a semimonthly (LVFU2) with a monthly (FULV) regimen of fluorouracil and leucovorin and 24 versus 36 weeks of each regimen as adjuvant treatment of patients with stage II (Dukes' B2) and III (Dukes' C) colon cancer. PATIENTS AND METHODS: LVFU2 was administered semi-monthly for 2 consecutive days as dl- or l-leucovorin (200 or 100 mg/m2, respectively) as a 2-hour infusion, followed by a 400 mg/m2 FU bolus and 600 mg/m2 of FU as a 22-hour continuous infusion. FULV was administered monthly for 5 consecutive days as a 15-minute infusion of dl- or l-leucovorin, followed by 400 mg/m2 of FU as a 15-minute infusion. RESULTS: A total of 905 patients were randomly assigned. The median follow-up was 41 months. Disease-free survival was similar between the LVFU2 and FULV groups (127 v 124 events; hazard ratio [HR] = 1.04; P =.74) and between 24 and 36 weeks of therapy (128 v 123 events; HR = 0.94; P =.63). Analysis of overall survival showed a slight excess in the number of deaths in LVFU2 compared with FULV (73 v 59), but this difference was not statistically significant (HR = 1.26; 95% confidence interval, 0.90 to 1.78; P =.18). The most commonly observed grade 3 to 4 toxicities were neutropenia, diarrhea, and mucositis. Toxicities were significantly lower in the LVFU2 group (all toxicities, P <.001). CONCLUSION: Our data confirm that LVFU2 is less toxic than FULV. At a median follow-up of 41 months, no statistically significant difference could be detected in disease-free or overall survival between the treatment groups or treatment durations.

Adenocarcinoma↗

PubMed2006

Frequent Hemodialysis Network (FHN) randomized trials: study design.

Observational studies suggest improvements with frequent hemodialysis (HD), but its true efficacy and safety remain uncertain. The Frequent Hemodialysis Network Trials Group is conducting two multicenter randomized trials of 250 subjects each, comparing conventional three times weekly HD with (1) in-center daily HD and (2) home nocturnal HD. Daily HD will be delivered for 1.5-2.75 h, 6 days/week, with target eK(t)/V(n) > or = 0.9/session, whereas nocturnal HD will be delivered for > or = 6 h, 6 nights/week, with target stdK(t)/V of > or = 4.0/week. Subjects will be followed for 1 year. The composite of mortality with the 12-month change in (i) left ventricular mass index (LVMI) by magnetic resonance imaging, and (ii) SF-36 RAND Physical Health Composite (PHC) are specified as co-primary outcomes. The seven main secondary outcomes are between group comparisons of: change in LVMI, change in PHC, change in Beck Depression Inventory score, change in Trail Making Test B score, change in pre-HD serum albumin, change in pre-HD serum phosphorus, and rates of non-access hospitalization or death. Changes in blood pressure and erythropoiesis will also be assessed. Safety outcomes will focus on vascular access complications and burden of treatment. Data will be obtained on the cost of delivering frequent HD compared to conventional HD. Efforts will be made to reduce bias, including blinding assessment of subjective outcomes. Because no large-scale randomized trials of frequent HD have been previously conducted, the first year has been designated a Vanguard Phase, during which feasibility of randomization, ability to deliver the interventions, and adherence will be evaluated.

Clinical Protocols↗

PubMedDate not supplied

Cholesterol lowering with statin drugs, risk of stroke, and total mortality. An overview of randomized trials.

OBJECTIVE: To examine whether cholesterol lowering with 3-hydroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase inhibitors (statin drugs) reduces the risks of stroke and total mortality. DATA SOURCES: We conducted a computerized literature search from 1985 through 1995 to identify all published trials testing statin drugs. The Cholesterol and Recurrent Events (CARE) data were added after the report was published in October 1996. Our search was limited to English-language articles and included published overviews containing relevant individual trials. TRIAL SELECTION: Criteria for inclusion of randomized trials in the overview were (1) statin drugs alone used to reduce lipid levels rather than multifactorial interventions including another type of cholesterol-lowering drug and (2) inclusion of data on deaths and/or strokes. DATA EXTRACTION: Data were extracted by 2 researchers, and only minor discrepancies, which were easily resolved by discussion, occurred. Principal investigators of the trials and their funding agencies were also contacted to secure any relevant data not included in the published reports. DATA SYNTHESIS: A total of 16 individual trials including approximately 29 000 subjects treated and followed up an average of 3.3 years were included in the overview. The average reductions in total and low-density lipoprotein cholesterol achieved were large-22% and 30%, respectively. A total of 454 strokes (fatal plus nonfatal) and 1175 deaths occurred. Those assigned to statin drugs experienced significant reductions in risks of stroke of 29% (95% confidence interval [CI], 14%-41%) as well as total mortality of 22% (95% CI, 12%-31%), which was attributable to a significant reduction in cardiovascular disease (CVD) deaths of 28% (95% CI, 16%-37%). There was no evidence of any increased risk in non-CVD mortality (relative risk [RR], 0.93; 95% CI, 0.75-1.14). There was also no significant increase in risk of cancer (RR, 1.03; 95% CI, 0.90-1.17). CONCLUSION: This overview of all published randomized trials of statin drugs demonstrates large reductions in cholesterol and clear evidence of benefit on stroke and total mortality. There was, as expected, a large and significant decrease in CVD mortality, but there was no significant evidence for any increases in either non-CVD deaths or cancer incidence.

Anticholesteremic Agents↗

PubMed2004

Cilostazol, clopidogrel or ticlopidine to prevent sub-acute stent thrombosis: a meta-analysis of randomized trials.

BACKGROUND: Sub-acute thrombosis is a serious complication of coronary artery stenting. Clopidogrel plus aspirin is the accepted prophylactic regimen, but has yet to be proven superior to ticlopidine plus aspirin, and a new regimen combining cilostazol and aspirin has been introduced. METHODS: We conducted a meta-analysis of all trials that compared >or=2 oral anti-thrombotic strategies in patients undergoing coronary stent placement to determine which treatment optimally prevents adverse cardiac events in the 30 days following stent insertion. We used meta-regression to compare all strategies to a shared control strategy: ticlopidine plus aspirin. We also compared randomized trials to historically controlled and other non-randomized trials. We conducted sensitivity analysis and subgroup analysis to assess for possible heterogeneity. RESULTS: In comparison to ticlopidine plus aspirin the odds-ratios for cardiac events, with 95% confidence intervals were: aspirin alone, 4.29 (3.09-5.97), coumadin plus aspirin, 2.65 (2.18-3.21), clopidogrel plus aspirin, 1.06 (0.86-1.31), cilostazol plus aspirin, 0.73 (0.47-1.14). Among trials that compared clopidogrel plus aspirin to ticlopidine plus aspirin, historically controlled trials were statistically distinct from randomized trials. The analysis of cilostazol was sensitive to the small size of the included studies. CONCLUSIONS: Neither clopidogrel plus aspirin nor cilostazol plus aspirin can be statistically distinguished from ticlopidine plus aspirin for the prevention of adverse cardiac events in the 30 days after stenting. A randomized trial including cilostazol is warranted.

Anticoagulants↗

PubMed1983

Lack of efficacy of a decongestant-antihistamine combination for otitis media with effusion ("secretory" otitis media) in children. Results of a double-blind, randomized trial.

In a double-blind, randomized trial of 553 infants and children who had otitis media with effusion ("secretory" otitis media), we compared the efficacy of a four-week course of an oral decongestant-antihistamine combination (pseudoephedrine hydrochloride, 4 mg per kilogram of body weight per day, and chlorpheniramine maleate, 0.35 mg per kilogram per day) with that of placebo. Among patients with initially unilateral disease, resolution of middle-ear effusion occurred at four weeks in 38 per cent of those treated with placebo and 34 per cent of those treated with drug (P = 0.74). Among patients with initially bilateral disease the corresponding proportions were 19 and 21 per cent, respectively (P = 0.67). Side effects were reported more often among drug-treated than placebo-treated patients. Decongestant-antihistamine combinations do not appear to be indicated for the treatment of otitis media with effusion in infants and children.

Child↗

PubMed2002

The placebo effect and randomized trials: analysis of conventional medicine.

Randomized controlled trials are generally regarded as the gold standard of study designs to determine causality. The inclusion of a placebo group in these trials, when appropriate, is critical to access the efficacy of a drug or supplement. The placebo response itself has received some attention in the medical literature over the past fifty years. The recent increasing utilization of dietary supplements and herbal medications by patients makes it imperative to reevaluate the placebo response in conventional and alternative medicine. This article will review a whole series of unique conditions (allergies/asthma, alopecia, BPH, erectile dysfunction, osteoporosis, weight loss...) and the placebo response associated with them from conventional medical randomized trials.

Alopecia↗

PubMed2002

The placebo effect and randomized trials: analysis of alternative medicine.

Randomized controlled trials are generally regarded as the gold standard of study designs to determine causality. The inclusion of a placebo group in these trials, when appropriate, is critical to access the efficacy of a drug or supplement. The placebo response itself has received some attention in the medical literature over the past fifty years. The recent increasing utilization of dietary supplements and herbal medications by patients makes it imperative to reevaluate the placebo response in conventional and alternative medicine. This article will review some of the negative and positive results from randomized trials utilizing dietary supplements (androstenedione, beta-carotene, CoQ10, garlic, soy, vitamin C and E...) for a number of non-urologic and urologic conditions, including cancer.

Androstenedione↗

PubMed2006

Cochrane reviews in pregnancy: the role of perinatal randomized trials and systematic reviews in establishing evidence.

Evidence from randomized trials and systematic reviews provides the highest level of evidence from which to make clinical decisions. There are over 340 Cochrane reviews and protocols in pregnancy and childbirth; these provide the best single source of evidence for care of pregnant women and their babies, and highlight further research priorities. The challenges to health professionals are to ensure that the Cochrane reviews are prepared, kept up to date, and used in clinical care, and where relevant reliable evidence is not available to ensure that high-quality randomized trials are promptly conducted.

Evidence-Based Medicine↗

PubMed2003

Hierarchy of evidence: differences in results between non-randomized studies and randomized trials in patients with femoral neck fractures.

INTRODUCTION: There have been a number of non-randomized studies comparing arthroplasty with internal fixation in patients with femoral neck fractures. However, there remains considerable debate about whether the results of non-randomized studies are consistent with the results of randomized, controlled trials. Given the economic burden of hip fractures, it remains essential to identify therapies to improve outcomes; however, whether data from non-randomized studies of an intervention should be used to guide patient care remains unclear. We aimed to determine whether the pooled results of mortality and revision surgery among non-randomized studies were similar to those of randomized trials in studies comparing arthroplasty with internal fixation in patients with femoral neck fractures. MATERIALS AND METHODS: We conducted a Medline search from 1969 to June 2002, identifying both randomized and non-randomized studies comparing internal fixation with arthroplasty in patients with femoral neck fractures. Additional strategies to identify relevant articles included Cochrane database, SCISEARCH, textbooks, annual meeting programs, and content experts. We abstracted information on mortality and revision rates in each study and compared the pooled results between non-randomized and randomized studies. In addition, we explored potential reasons for dissimilar results between the two study designs. RESULTS: We identified 140 citations that addressed the general topic of comparison of arthroplasty and internal fixation for hip fracture. Of these, 27 studies met the eligibility criteria, 13 of which were non-randomized studies and 14 of which were randomized trials. Mortality data was available in all 13 non-randomized studies ( n=3108 patients) and in 12 randomized studies ( n=1767 patients). Non-randomized studies overestimated the risk of mortality by 40% when compared with the results of randomized trials (relative risk 1.44 vs 1.04, respectively). Information on revision risk was available in 9 non-randomized studies ( n=2764 patients) and all 14 randomized studies ( n=1901 patients). Both estimates from non-randomized and randomized studies revealed a significant reduction in the risk of revision surgery with arthroplasty compared with internal fixation (relative risk 0.38 vs 0.23, respectively). The reduction in the risk of revision surgery with arthroplasty compared with internal fixation was 62% for non-randomized studies and 77% for randomized trials. Thus, non-randomized studies underestimated the relative benefit of arthroplasty by 19.5%. Non-randomized studies with point estimates of relative risk similar to the pooled estimate for randomized trials all controlled for patient age, gender, and fracture displacement in their comparisons of mortality. We were unable to identify reasons for differences in the revision rate results between the study designs. CONCLUSIONS: Similar to other reports in medical subspecialties, non-randomized studies provided results dissimilar to randomized trials of arthroplasty vs internal fixation for mortality and revision rates in patients with femoral neck fractures. Investigators should be aware of these discrepancies when evaluating the merits of alternative surgical interventions, especially when both randomized trials and non-randomized comparative studies are available.

Arthroplasty, Replacement, Hip↗

PubMed1991

Adjuvant treatment in stage I and II malignant melanoma: a randomized trial between chemoimmunotherapy and immunotherapy.

A randomized trial comparing chemoimmunotherapy (bacillus Calmette-Guérin + chemotherapy) and immunotherapy (bacillus Calmette-Guérin alone) was carried out in high-risk stage I and II malignant melanoma patients. Eight-two evaluable patients were included. The follow-up median duration was 11 years. Recurrent melanoma developed in 28 patients (34%). The overall survival rate was 76% at 5 years and 65% at 10 years. There were no statistical differences in survival probability or disease-free survival (DFS) probability between the two treatment groups. Survival and DFS were also analyzed in relation to various prognostic factors. Statistically significant differences were only seen in a subset of 33 patients with lower limb malignant melanoma, the prognosis being better for the chemoimmunotherapy group in this location. Because of the small number of patients in each group, a week positive effect of either of these two treatments cannot be ruled out. Chemoimmunotherapy only seems to improve the prognosis of stage I or II malignant melanoma of the legs.

Adult↗

PubMed1992

Isradipine for the treatment of hypertension following coronary artery bypass graft surgery: a randomized trial versus sodium nitroprusside.

In a randomized trial, a calcium antagonist, isradipine (ISR) and sodium nitroprusside (SNP) were compared in the management of hypertension in the early period following coronary artery bypass grafting (CABG). Patients with a mean arterial pressure (MAP) of greater than 100 mmHg were treated with a 6 h i.v. infusion of ISR (n = 98) or SNP (n = 100). Mean MAP at baseline was 113 (ISR) and 112 mmHg (SNP). Blood pressure control (MAP less than or equal to 90 mmHg within 25 min) was achieved in 92% (ISR) and 84% (SNP), within a mean of 12 and 15 min, respectively (P less than 0.01 between groups). At 25 min, mean percentage changes from baseline for ISR and SNP were: MAP -24.3% vs. -21.4% (P less than 0.05), heart rate +4.1% vs. +8.4% (P less than 0.01), rate-pressure-product -16.9% vs. -10.6% (P less than 0.001), cardiac index +19.2% vs. +4.6% (P less than 0.001), stroke volume index +16.1% vs. -1.9% (P less than 0.001), and peripheral vascular resistance -35.4% vs. -22.0%, (P less than 0.001). Treatment was discontinued before 6 h in 24 patients in each group because of low blood pressure. Hypotension (MAP less than 70 mmHg) and tachycardia were less frequent with ISR than with SNP. In conclusion, ISR is effective and well tolerated in the treatment of hypertension following CABG, and has a haemodynamic profile which may be more favourable than that seen after treatment with SNP.

Adult↗

PubMed1995

[Single high-dose and fractionated low dose cisplatin in the EP protocol for advanced NSCLC--a prospective randomized trial on 72 patients].

A prospective randomized trial on 72 patients (12 cases in stage III and 60 cases in stage IV) suffering from non-small cell lung cancer (NSCLC) was carried out from January 1993 to March 1994 to assess the immediate results of single high dose DDP and fractionated low doses DDP in the EP (Etoposide and Cisplatin, DDP) protocol. The response rate to the former regimen was 47.1% (16/34) as compared with 39.5% (15/38) of the latter. The difference between these two regimens were not statistically significant (P > 0.10). The former regimen had higher incedence of delayed vomiting (P < 0.01), but the latter had more severe bone marrow suppression (P < 0.05). Without significant difference in renal toxicity (P > 0.10). The authors suggest that, the EP protocol consisting of fractionated doses of DDP, may be more preferrable due to its mild gastro-intestinal toxic reaction and less expensive in the treatment of advanced NSCLC patients. Yet, it is necessary to guard against its renal toxicity and myelosuppression.

Antineoplastic Combined Chemotherapy Protocols↗

PubMed2005

Effect of antithrombotic therapy in patients with mitral stenosis and atrial fibrillation: a sub-analysis of NASPEAF randomized trial.

AIMS: The randomized NASPEAF study included non-valvular with prior embolism and mitral stenosis patients in the same group. This is a sub-study to specially focus on the antithrombotic therapy in mitral stenosis. METHODS AND RESULTS: We analysed 311 patients with mitral stenosis, compared with 175 non-valvular atrial fibrillation patients with prior embolism, stratified by a history of previous embolism and assigned to anticoagulant therapy [target international normalized ratio (INR) = 2.0-3.0] or combined antiplatelet plus moderate intensity anticoagulant therapy. Median follow-up was 2.9 years. Outcomes were fatal and non-fatal embolism, stroke and myocardial infarction, sudden death, and death from bleeding. Combined therapy in mitral stenosis patients, compared with anticoagulant alone therapy, reduced the risk of vascular events by 58.3%. During equal therapy, the outcome annual rates were essentially the same in non-valvular and valvular patients [hazard ratio 0.90 (95% confidence interval 0.37-2.16), P = 0.81]. During anticoagulant alone therapy, the annual event rate in mitral stenosis patients without prior embolism was low (2.5%) and it was very high in patients with prior embolism (6.6%). CONCLUSION: Combined therapy was effective in mitral stenosis patients. Prior embolism patients are not efficiently protected with anticoagulant alone therapy for an INR of 2.0-3.0.

Aged↗

PubMed1999

A multicenter, randomized trial of percutaneous coronary intervention versus bypass surgery in high-risk unstable angina patients. The AWESOME (Veterans Affairs Cooperative Study #385, angina with extremely serious operative mortality evaluation) investigators from the Cooperative Studies Program of the Department of Veterans Affairs.

This multicenter, prospective randomized trial was designed to test the hypotheses that percutaneous coronary intervention (PCI) is a safe and effective alternative to coronary artery bypass grafting (CABG) for patients with refractory ischemia and high risk of adverse outcomes. As a comparison of revascularization strategies, the trial specifically allows surgeons and interventionists to use new techniques as they become clinically available. After 42 months of this 72-month trial, 17,624 patients have been screened and 2022 met eligibility requirements: 341 have been randomized to either CABG or PCI, and the remaining 1681 are being prospectively followed in a registry. The 3-year overall survival of patients in the registry and randomized trial is comparable. To enhance accrual into the randomized trial, site visits were conducted, a few low-accruing hospitals were put on probation and/or replaced, eligibility criteria were reviewed at annual meetings of investigators, and the accrual period was extended by 1 year. These data demonstrate that a prospective randomized trial and registry of coronary revascularization for medically refractory high-risk patients is feasible.

Age Factors↗

PubMed2000

Hydroxyurea versus busulphan for chronic myeloid leukaemia: an individual patient data meta-analysis of three randomized trials. Chronic myeloid leukemia trialists' collaborative group.

Although interferon alpha (IFN) has been shown to prolong survival in chronic myeloid leukaemia (CML), it cannot be used in all patients. Reliable evidence on the relative benefits of busulphan and hydroxyurea is of value in treating those patients who will not receive interferon. Data for each individual patient was sought from trials which randomized patients with CML to hydroxyurea vs. busulphan. Intention-to-treat stratified log rank survival analyses were performed, reporting two-sided P-values. Data were collected on 812 patients in the three trials identified. In the group of 690 patients with confirmed Philadelphia chromosome (Ph)-positive CML, survival at 4 years was 45.1% with busulphan and 53.6% with hydroxyurea, an absolute benefit of 8.5% (95% confidence interval 0. 1-16.9; logrank P = 0.01 over 4 years). There seemed to be no further benefit for hydroxyurea in later years, but there was no apparent delayed adverse effect either. The difference between hydroxyurea and busulphan was not statistically significantly different from the overall result in any subgroup. Survival of patients with Ph-positive CML is better with hydroxyurea treatment than with busulphan.

Antineoplastic Agents↗

PubMed1984

Complications following postoperative combined radiation and chemotherapy in adenocarcinoma of the rectum and rectosigmoid. A randomized trial that failed.

A randomized multicenter trial was started to evaluate the effect of irradiation combined with 5-fluorouracil and methotrexate on survival after surgery for rectal and rectosigmoidal carcinoma, Dukes' stages B and C. The trial was terminated prematurely after entrance of 34 patients due to frequent and serious complications. Three patients died as a direct consequence of the adjuvant treatment.

Adenocarcinoma↗