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Results for “Randomized trial”

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PubMed2002

Gemcitabine in the treatment of advanced pancreatic cancer: a comparative analysis of randomized trials.

In view of the data available from randomized trials, gemcitabine has been established as a new standard for the treatment of pancreatic cancer. It was shown to improve clinical benefit response, time to progression, and survival when compared with agents such as 5-fluorouracil or metalloproteinase inhibitors. In one trial, the combination of cisplatin and gemcitabine significantly improved tumor response and time to progression as compared with gemcitabine alone, while a significant impact on survival yet needs to be shown. No significant, clinically meaningful survival benefit was observed when gemcitabine was combined with bolus or infusional 5-fluorouracil, capecitabine, metalloproteinase inhibitors, or the FTI tipifarnib. Numerous ongoing randomized trials are presently investigating gemcitabine-based combination regimens involving such agents as cisplatin, oxaliplatin, irinotecan, docetaxel, 5-fluorouracil, capecitabine, or pemetrexed.

Antimetabolites, Antineoplastic↗

PubMed2004

Risk-benefit profile for raloxifene: 4-year data From the Multiple Outcomes of Raloxifene Evaluation (MORE) randomized trial.

UNLABELLED: Posthoc analysis of the MORE osteoporosis treatment trial assessed risk-benefit profile of raloxifene in 7705 postmenopausal women. A major disease outcomes global index resulted in annual rates of 1.39% and 1.83% in the raloxifene and placebo groups, respectively (HR, 0.75; 95% CI, 0.62-0.92), compatible with a favorable risk-benefit profile for raloxifene for treating postmenopausal osteoporosis. INTRODUCTION: The Women's Health Initiative (WHI) trial reported overall risks that exceeded benefits from use of estrogen-progestin in healthy postmenopausal women. The objective of this posthoc analysis of the Multiple Outcomes of Raloxifene Evaluation (MORE) trial was to assess the safety profile of raloxifene, a selective estrogen receptor modulator indicated for the prevention and treatment of osteoporosis, using the global index method from the WHI trial. MATERIALS AND METHODS: A total of 7705 postmenopausal women (mean age, 67 years) were enrolled in the MORE osteoporosis treatment trial and randomly assigned to receive placebo or one of two doses of raloxifene (60 or 120 mg/day) for 4 years. A global index of clinical outcomes, defined as described for the WHI trial (the earliest occurrence of coronary heart disease, stroke, pulmonary embolism, invasive breast cancer, endometrial cancer, colorectal cancer, hip fracture, or death because of other causes) was applied to the MORE trial data. Physicians blinded to treatment assignment adjudicated events. Intention-to-treat survival analysis of time-to-first-event was performed using a proportional hazards model. RESULTS AND CONCLUSIONS: The annualized rate of global index events was 1.83% in the placebo group and 1.39% in the combined raloxifene dose groups (hazard ratio [HR], 0.75; 95% CI, 0.62-0.92). Analyzing individual dose groups separately yielded the same results (HR for 60 mg/day, 0.75; 95% CI, 0.60-0.96: HR for 120 mg/day, 0.75; 95% CI, 0.59-0.95). Subgroup analyses showed no significant interactions between age or hysterectomy status and the effect of raloxifene on the global index (interaction p > 0.1), whereas the global index risk reduction seemed to be greater in obese women compared with nonobese women (interaction p = 0.03). The significant 25% reduction in global index is compatible with a favorable risk-benefit safety profile when raloxifene is used for osteoporosis treatment in postmenopausal women. These results require confirmation in ongoing clinical trials.

Aged↗

PubMed2006

Role of radiotherapy with surgery for T3 and resectable T4 rectal cancer: evidence from randomized trials.

PURPOSE: The main treatment for resectable rectal cancer T2-T4 N0-N2 M0 is surgery. The benefit of preoperative or postoperative radiation therapy can be analyzed in terms of improvement of local control, sphincter preservation, and survival weighted against increased toxicity. METHODS: Only randomized trials can provide strong evidence of a positive cost-benefit ratio of such combined approach. The most recent trials were reviewed. RESULTS: Three randomized trials, including the latest German CAO-ARO trial, have demonstrated the superiority of preoperative radiotherapy with or without chemotherapy (vs. postoperative) in terms of local control and toxicity. The Ducth TME trial showed that even with modern standard surgery, preoperative radiotherapy improved local control. Preoperative irradiation using a high dose in a small volume and a long interval before surgery may improve sphincter preservation (Lyon trials). Concurrent chemoradiation (FFCD 9203, EORTC 22921, did not significantly improve sphincter preservation or survival but significantly reduced the local recurrence rate. CONCLUSIONS: In 2005 examination of randomized trials provides evidence for the benefit of preoperative chemoradiation in improving local control and probably sphincter preservation in rectal cancer. Randomized trials should be designed to further demonstrate improved sphincter preservation and to increase survival using adjuvant medical treatments.

Clinical Trials, Phase III as Topic↗

PubMed1995

Cost-effectiveness comparisons using "real world" randomized trials: the case of new antidepressant drugs.

While randomized clinical trials remain the "gold standard" for comparisons of treatment efficacy, conventional randomized trials may not reflect the relative effectiveness of treatments under "real world" conditions. Observational data more closely reflect the conditions of actual practice, but are often limited in clinical detail and subject to bias in selection of treatments. The authors use available data on the cost-effectiveness of new antidepressant drugs to illustrate the limitations of these methods. Modifications to the traditional randomized trial may allow more accurate assessment of effectiveness in everyday practice. The authors describe the design of such a "real world" randomized trial comparing newer antidepressants with older alternatives.

Antidepressive Agents↗

PubMed2005

Differential recruitment in a cluster randomized trial in primary care: the experience of the UK back pain, exercise, active management and manipulation (UK BEAM) feasibility study.

BACKGROUND: Cluster randomized trials, which randomize groups of patients rather than individuals, are commonly used to evaluate healthcare interventions such as training programmes targeted at health professionals. This article reports the dangers of randomizing entire primary care practices when participants cannot be identified before randomization, as shown by a UK national trial. METHOD: The UK BEAM trial, a national cluster randomized 3 x 2 x 2 factorial trial, was designed to evaluate three treatments for back pain in primary care: "active management"; randomized by practice; and spinal manipulation and exercise classes, both randomized by individual. RESULTS: Two hundred and thirty-one participants were recruited in the feasibility study, 165 (141% of expected recruitment) from active (management) practices but only 66 (54% of expected recruitment) from traditional (management) practices. The participants in active practices were significantly different from those in traditional practices, notably in suffering from milder back pain. CONCLUSIONS: The feasibility study highlighted the dangers of randomizing clusters when individuals cannot be identified beforehand. Different numbers and types of participants were recruited in the two types of cluster. This differential recruitment led us to change the main trial design by abandoning practice level randomization. Instead all practices were trained in active management to maximize recruitment. Ideally cluster randomized trials should identify patients beforehand, to minimize the chance of selection bias. If this is not possible, patient recruitment should be independent in both intervention and control clusters. Pilot studies are especially important for cluster randomized trials, to identify unforeseen problems.

Adult↗

PubMed1987

Efficacy of amoxicillin with and without decongestant-antihistamine for otitis media with effusion in children. Results of a double-blind, randomized trial.

In a randomized, double-blind, placebo-controlled trial involving 518 infants and children who had otitis media with effusion ("secretory" otitis media), we evaluated the efficacy of a two-week course of amoxicillin (40 mg per kilogram of body weight per day) with and without a four-week course of an oral decongestant-antihistamine combination. Among the 474 subjects who were evaluated at the four-week end point, the rate of resolution of middle-ear effusion was twice as high in those treated with amoxicillin, either with or without the decongestant-antihistamine, as in those who received placebo (P less than 0.001), but 69.8 percent of the amoxicillin-treated subjects still had effusion. Among both the amoxicillin-treated subjects and the placebo-treated subjects, resolution was more likely in those with initially unilateral effusion, in those who had had effusion for eight weeks or less, and in those without an upper respiratory tract infection at the four-week end point. Side effects were reported more often in subjects who received decongestant-antihistamine than in those who did not. Among the subjects without effusion at the four-week end point, recurrent effusion developed in approximately half those in both the amoxicillin and placebo groups during the subsequent three months. We conclude that in infants and children with otitis media with effusion, amoxicillin treatment increases to some extent the likelihood of resolution.

Amoxicillin↗

PubMed1993

A method for the analysis of randomized trials with compliance information: an application to the Multiple Risk Factor Intervention Trial.

The standard approach to analyzing randomized trials ignores information on postrandomization compliance. Application of these methods results in estimates that may lack the desired causal interpretation. We employ a new method of estimation and analyze data from the Multiple Risk Factor Intervention Trial (MRFIT) to estimate the causal effect of quitting cigarette smoking. Our procedure utilizes a method proposed by Robins and Tsiatis and allows us to take advantage of postrandomization smoking history without requiring untenable assumptions about the comparability of compliers and noncompliers. We contrast the performance of our method and the standard intent-to-treat analysis in the MRFIT data and in simulated data in which compliance rates are varied.

Adult↗

PubMedDate not supplied

Effect of short-term cognitive psychotherapy on recurrence of duodenal ulcer: a prospective randomized trial.

The aim of this prospective, randomized trial was to assess whether short-term cognitive psychotherapy (10 sessions during 4 months) could reduce the 1-year recurrence rate of duodenal ulcer. One group received psychotherapy; one group was a control group. One hundred patients, aged 17 to 64 years, with duodenal ulcer were selected from March 1989 to May 1991. The main outcome measure was relapse of duodenal ulcer, which was verified by endoscopy. When psychotherapy started after cessation of antiulcer medication, the relapse-free time was significantly shorter in the therapy group than in the controls. When the protocol was modified so that psychotherapy and antiulcer medication were given concomitantly, there was no significant difference in recurrence rate between the groups at 1-year follow-up (84% in the therapy group and 92% in the control group). Symptoms of upper abdominal discomfort/pain, measured every second month, decreased significantly in the therapy group compared to the control group. Psychotherapy led to less neuroticism (Eysenck Personality Questionnaire) and less trait anxiety (Spielberger Trait Anxiety Scale) compared to controls at 4 months. At the 12-month follow-up, most of this gain was lost, but the psychotherapy group had lower scores on "concern about disapproval" on the Sociotropy-Autonomy Scale than the control group. There is no beneficial effect of short-term cognitive psychotherapy on the 1-year recurrence rate of duodenal ulcer.

Adaptation, Psychological↗

PubMed1990

Allogeneic marrow transplantation in patients with acute myeloid leukemia in first remission: a randomized trial of two irradiation regimens.

A randomized trial of 12.0 Gy versus 15.75 Gy of total body irradiation (TBI) was performed in patients with acute myeloid leukemia undergoing allogeneic marrow transplantation while in first complete remission. All patients received 120 mg/kg cyclophosphamide followed by TBI and marrow from HLA-identical siblings. Cyclosporine and methotrexate were used for prophylaxis against acute graft-versus-host disease (GVHD). Thirty-four patients received 2.0-Gy fractions of irradiation daily for 6 days and 37 received 2.25-Gy fractions daily for 7 days. The 3-year actuarial probabilities for relapse-free survival were 0.58 for the patients who received 12.0 Gy and 0.59 for those who received 15.75 Gy. The 3-year probabilities of relapse were 0.35 for the 12.0 Gy group and 0.12 for the 15.75 Gy group (P = .06). The 3-year probabilities of transplant-related mortality were 0.12 and 0.32, respectively (P = .04). The probability of moderate to severe acute GVHD was 0.21 for the 12.0 Gy group and 0.48 for the 15.75 Gy group (P = .02). Patients exposed to the higher irradiation dose received less immunoprophylaxis against, and had a higher incidence of, acute GVHD. The increased dose of TBI significantly reduced the probability of relapse but did not improve survival because of increased mortality from causes other than relapse.

Adolescent↗

PubMedDate not supplied

Randomized trial comparing a radially expandable needle system with cutting trocars.

Sharp trocar insertion for laparoscopic procedures carries with it increased risk for vascular and visceral complications and incisional hernia. In a trial, which randomized 87 patients to treatment with either sharp trocars or a radially expanding needle system with blunt dilator, results showed that with the latter system there was statistically improved patient assessment of pain, a lower complications rate, and shorter procedure time. In the group of patients randomized to treatment with conventional trocars, there were a total of six instrument-related adverse events (6/42): four cases (five incidences) of abdominal wall injuries and one small bowel perforation caused by a Veress needle. Of the 45 patients randomized to the blunt dilator/cannula treatment, there was one adverse event (1/45) that was unrelated to the blunt dilator/cannula system: Veress needle injury to abdominal vasculature. The radially expanding access system demonstrates statistically improved patient postoperative comfort and improved patient safety.

Adult↗

PubMed1988

Treatment of gram-negative septic shock with human IgG antibody to Escherichia coli J5: a prospective, double-blind, randomized trial.

In a randomized, double-blind, multicenter trial we compared the efficacy of a preparation of human IgG antibody to Escherichia coli J5 (J5-IVIG) with that of a standard IgG preparation (IVIG) for the treatment of gram-negative septic shock. At study entry, patients received a single intravenous dose of 200 mg/kg of body weight (maximal dose, 12 g) of either J5-IVIG or IVIG. Of the 100 patients randomized, 71 (30 receiving J5-IVIG and 41 receiving IVIG) had a documented gram-negative infection. Mortality from gram-negative septic shock was 50% (15 of 30) in J5-IVIG recipients and 49% (20 of 41) in IVIG recipients. In addition, treatment with J5-IVIG did not reduce the number of systemic complications of shock and did not delay the occurrence of death due to septic shock. Thus we conclude that J5-IVIG was not superior to IVIG in reducing mortality or in reversing gram-negative septic shock.

Adolescent↗

PubMed1997

A randomized trial of the impact of telephone and recorded delivery reminders on the response rate to research questionnaires.

BACKGROUND: A range of factors have been shown to affect the response rate to mailed questionnaires, but particular strategies to improve patients' response in trials conducted in general practice require further study. METHODS: Non-responders in a larger trial were randomized to receive a telephone or recorded delivery reminder on the third contact. The cost of administration of each method was estimated. RESULTS: Significantly more patients returned completed questionnaires when sent questionnaires by recorded delivery, although the cost per patient contacted was nearly three times more than for contact by telephone. CONCLUSION: Our study indicates that sending reminders by recorded delivery, although more expensive, is more effective than telephone reminders for recruiting patients to a study in general practice using research questionnaires.

Adult↗

PubMed2004

A randomized trial comparing myocardial salvage achieved by coronary stenting versus balloon angioplasty in patients with acute myocardial infarction considered ineligible for reperfusion therapy.

OBJECTIVES: We assessed myocardial salvage achieved by reperfusion with percutaneous coronary interventions (PCI) and compared stenting with balloon angioplasty (PTCA) in patients with acute myocardial infarction (AMI) ineligible for thrombolysis. BACKGROUND: A substantial proportion of patients with AMI are currently considered ineligible for thrombolysis, and reperfusion treatment is frequently not recommended for them. It is not known whether these patients benefit from PCI. METHODS: The Stent or PTCA for Occluded Coronary Arteries in Patients with Acute Myocardial Infarction Ineligible for Thrombolysis (STOPAMI-3) trial, a randomized, open-label study, included 611 patients with AMI who were ineligible for thrombolysis (lack of ST-segment elevation on the electrocardiogram, late presentation >12 h after symptom onset, and contraindications to thrombolysis). Patients were randomly assigned to receive either coronary artery stenting (n = 305) or PTCA (n = 306). Scintigraphic myocardial salvage index (proportion of the initial myocardial perfusion defect that was salvaged by reperfusion) was the primary end point of the study. RESULTS: A considerable myocardial salvage was achieved with both stenting and PTCA. In patients assigned to receive stenting, the median size of the salvage index was 0.54 (25th and 75th percentiles, 0.29 and 0.87), as compared with a median of 0.50 (25th and 75th percentiles, 0.26 and 0.82) in the group assigned to receive PTCA (p = 0.20). Mortality at six months was 8.2% in the group of patients assigned to receive stenting and 9.2% in the group of patients assigned to receive PTCA (p = 0.69). CONCLUSIONS: Patients with AMI who are currently considered ineligible for thrombolysis by conventional guidelines may greatly benefit from primary PCI. The benefit seems to be comparable when a strategy of stenting is compared with a strategy of PTCA in these patients.

Angioplasty, Balloon, Coronary↗

PubMed2001

Final results of a randomized trial comparing the MULTI-LINK stent with the Palmaz-Schatz stent for narrowings in native coronary arteries.

The MULTI-LINK (ML) stent is a novel second generation coronary stent. The ACS MultiLink Stent Clinical Equivalence in De Novo Lesions Trial (ASCENT) randomized 1,040 patients with single, de novo native vessel lesions to treatment with the ML stent or the benchmark Palmaz-Schatz (PS) stent, to demonstrate that the ML stent was not inferior to (i.e., equivalent or better than) the PS stent in terms of target vessel failure by 9 months. Successful stent delivery was achieved in 98.8% versus 96.9% of patients, with a slightly lower postprocedural diameter stenosis (8% vs 10%, p = 0.04), and no difference in 30-day major adverse cardiac events (5.0% vs 6.5%) for the ML stent versus the PS stent. The primary end point of target vessel failure at 9 months was seen in 15.1% of ML-treated patients versus 16.7% of PS-treated patients, with the ML proving to be equal or superior to the PS stent (p <0.001 by test for equivalency). In a prespecified subset, angiographic restudy showed a nonsignificant trend for reduced ML restenosis (16.0% vs 22.1%). Thus, the ML stent showed excellent deliverability and acute results, with 9-month clinical and 6-month angiographic outcomes that were equivalent or better than the PS stent.

Aged↗

PubMed1993

Screening for lung cancer re-examined. A reinterpretation of the Mayo Lung Project randomized trial on lung cancer screening.

In the 1970s, three randomized trials, each involving approximately 10,000 male subjects, were carried out to determine the value of lung cancer screening in cigarette smokers. These studies have been widely interpreted as providing strong evidence that screening does not contribute to decreased death rates, and, accordingly, the American Cancer Society firmly recommends against lung cancer screening. No randomized trial, however, has evaluated screening for lung cancer in women, who currently comprise 39% of the lung cancer population. The trials performed at Memorial-Sloan Kettering and at Johns Hopkins were designed so that subjects were randomized to either a single screen (annual chest x-ray alone) or a dual screen (annual chest x-ray and every-4-month sputum cytology) group. While the results of both revealed no difference in mortality between the groups, these studies were designed to examine the value of sputum cytology, and no conclusion regarding the efficacy of chest x-rays can be inferred. In the Mayo Lung Project, patients were randomized to a screened group in which a chest x-ray and sputum cytology were obtained every 4 months or to a control group in which an annual chest x-ray and cytology were simply recommended. The results indicate that after 6 years, more lung cancers were detected among the 4,618 men in the screened group (206 cases, 4.46%) than in the 4,593 men in the control group (160 cases, 3.48%). The screened group showed a superiority over the control subjects in resectability rate (46% vs 32%) and 5-year survival (33% vs 15%). However, the number of cancer deaths was slightly greater in the screened (122) than in the control group (115), and, consequently, the mortality rates were not significantly different among the groups. An "overdiagnosis bias" has been suggested to account for the increased number of lung cancers detected in the screened vs the control population in the Mayo Lung Project. This explanation is statistically plausible, but, given the status of lung cancer as the most lethal of malignancies, is biologically unlikely. An alternative hypothesis is that chance alone might have accounted for the observed 0.98% difference in lung cancer detection rates. Were this the case, then 46 additional cases would have been detected in the control group had this chance event not occurred.(ABSTRACT TRUNCATED AT 400 WORDS)

Adult↗

PubMed2004

Exclusion of elderly women from published randomized trials of stress incontinence surgery.

OBJECTIVE: More than 20,000 women, aged 70 years or older, undergo surgery for stress urinary incontinence each year. Our objective was to review the published randomized trials of the surgical treatment of stress urinary incontinence and estimate the proportion of women 70 years or older enrolled in those trials. DATA SOURCES: MEDLINE and Cochrane Databases of Clinical Trials were searched from January 1966 through December 2003 with the terms "urinary incontinence," "stress incontinence," "urethropexy," "needle suspension," "pubovaginal sling," "tension-free vaginal tape," "urethral injection," "collagen injection," "anterior colporrhaphy," and "clinical trial," "controlled trial," or "randomized trial" as both subject headings and words contained in article titles. We supplemented this search with manual searches of meta-analyses and review articles from 2000 to 2003. METHODS OF STUDY SELECTION: All studies that included at least one group undergoing an invasive treatment for stress incontinence (including urethral bulking injections) were reviewed. We excluded reports without sufficient data to estimate the number of women aged 70 and older who participated, those published only in abstract form, and those studies in languages other than English, French, German, Italian, or Spanish. Twenty studies met our inclusion criteria. TABULATION, INTEGRATION, AND RESULTS: The number of women aged 70 or older in each study was estimated using the demographic data provided. The median percentage of subjects aged 70 or older was 3.8% (interquartile range 0.37-15%). There was no significant difference in the proportion of subjects 70 years of age or older based on the year of publication. CONCLUSION: Our review of the published literature suggests that elderly women are underrepresented in clinical trials of stress incontinence surgery. Efforts should be made to include more elderly women in clinical trials of stress incontinence surgery.

Aged↗

PubMed1982

Streptokinase in acute myocardial infarction: western Washington randomized trial--protocol and progress report.

A randomized trial of intracoronary thrombolysis in a multicenter, geographically limited community has been undertaken. There have been no deaths or important morbidity because of heart catheterization. Preliminary data analysis has shown that patient entry within 3 hours of the onset of infarction has been the exception rather than the rule. It is anticipated that this trial will be completed by mid 1983. It is hoped that the data obtained from this study will help clarify the role of thrombolysis in acute myocardial infarction.

Adult↗

PubMed1994

Hypertension in the elderly. Implications and generalizability of randomized trials.

OBJECTIVE: To estimate morbidity and mortality benefits of drug therapy for hypertensive elderly subjects, compare these benefits with effects in younger subjects, and provide a framework for generalizing results derived from trials to actual patients. DATA SOURCES: A literature search using MEDLINE from 1966 to 1993, references from reviews and trial articles, and experts. STUDY SELECTION: Randomized trials lasting at least 1 year that evaluated effects of drug treatment on morbidity and mortality outcomes in hypertensive persons. DATA EXTRACTION: Four independent reviewers appraised protocol characteristics and quality of selected trials. DATA SYNTHESIS: There were 13 trials involving 16,564 elderly persons (age 60 years and older). The prevalence of cardiovascular risk factors, cardiovascular disease, and competing comorbid diseases was lower among trial participants than the general population of hypertensive elderly persons. When the six large high-quality trials were combined, trial results showed 43 subjects (95% confidence interval [CI], 31 to 69) and 61 subjects (95% CI, 39 to 141) needed to be treated for 5 years to prevent one cerebrovascular event and one coronary heart disease event, respectively. Including the other seven trials did not change the results significantly. Only 18 subjects (95% CI, 14 to 25) needed to be treated to prevent one cardiovascular event (cerebrovascular or cardiac). Twelve trials in primarily younger and middle-aged adults involved approximately 33,000 persons. For all outcomes except cardiac mortality, two to four times as many of the younger subjects as the older subjects needed to be treated for 5 years to prevent morbid and mortal events. No significant effect on cardiac mortality was seen among younger subjects, while 78 older subjects (95% CI, 50 to 180) needed to be treated to prevent a fatal cardiac event. CONCLUSIONS: Randomized trials demonstrate that treating healthy older persons with hypertension is highly efficacious. Five-year morbidity and mortality benefits derived from trials are greater for older than younger subjects. Extrapolating benefits from trials to individual patients is difficult, but should take into account multiple issues including the patient's risk factors, preexisting cardiovascular disease, and competing comorbid illnesses.

Age Factors↗