SEARCH · PubMed Health

Results for “Randomized controlled trials”

Explore indexed PubMed citations for clinical trials, systematic reviews and public health research. Read source abstracts and follow each citation to its original PubMed record.

Quote a phrase for an exact phrase match. Source license links do not imply unrestricted reuse.

At least 181 records · Page 10Linked to original sources

PubMed2001

Periradicular infiltration for sciatica: a randomized controlled trial.

STUDY DESIGN: A randomized, double-blind trial was conducted. OBJECTIVES: To test the efficacy of periradicular corticosteroid injection for sciatica. SUMMARY OF BACKGROUND DATA: The efficacy of epidural corticosteroids for sciatica is controversial. Periradicular infiltration is a targeted technique, but there are no randomized controlled trials of its efficacy. METHODS: In this study 160 consecutive, eligible patients with sciatica who had unilateral symptoms of 1 to 6 months duration, and who never underwent surgery were randomized for double-blind injection with methylprednisolone bupivacaine combination or saline. Objective and self-reported outcome parameters and costs were recorded at baseline, at 2 and 4 weeks, at 3 and 6 months, and at 1 year. RESULTS: Recovery was better in the steroid group at 2 weeks for leg pain (P = 0.02), straight leg raising (P = 0.03), lumbar flexion (P = 0.05), and patient satisfaction (P = 0.03). Back pain was significantly lower in the saline group at 3 and 6 months (P = 0.03 and 0.002, respectively), and leg pain at 6 months (13.5, P = 0.02). Sick leaves and medical costs were similar for both treatments, except for cost of therapy visits and drugs at 4 weeks, which were in favor of the steroid injection (P = 0.05 and 0.005, respectively). By 1 year, 18 patients in the steroid group and 15 in the saline group underwent surgery. CONCLUSIONS: Improvement during the follow-up period was found in both the methylprednisolone and saline groups. The combination of methylprednisolone and bupivacaine seems to have a short-term effect, but at 3 and 6 months, the steroid group seems to experience a "rebound" phenomenon.

Adult↗

PubMed1997

Beneficial effects of intravenous and oral carvedilol treatment in acute myocardial infarction. A placebo-controlled, randomized trial.

BACKGROUND: Evidence of efficacy and safety of beta-blockers after thrombolysis for acute myocardial infarction (AMI) is equivocal. Newer beta-blockers such as carvedilol have not been tested in this setting. METHODS AND RESULTS: This study investigated the effects of acute (intravenous) and long-term (6 months, oral) treatment with carvedilol versus placebo in 151 consecutive patients with AMI. Exercise ECG, ambulatory monitoring, and two-dimensional echocardiography were performed before hospital discharge and at 3 and 6 months. All patients were followed up and cardiovascular events recorded. The Cox proportional hazards model was used to compare time from randomization with the occurrence of a cardiovascular event, and Kaplan-Meier survival curves were calculated. Carvedilol was found to be safe, and it significantly reduced cardiac events compared with placebo (18 on carvedilol and 31 on placebo, P < .02). Fifty-four patients had heart failure at study entry; 34 received carvedilol. There were no adverse effects of carvedilol therapy and no excess events in this subgroup. Carvedilol produced significant reductions in heart rate (P < .0001), blood pressure (P < .005) at rest, and rate-pressure product at peak exercise (P < .003), but exercise capacity was unchanged. Left ventricular ejection fraction was not altered significantly by carvedilol, but stroke volume was higher at pre-hospital discharge examination (63 versus 53 mL; P < .01). Diastolic filling of the left ventricle (E/A ratio) was also improved (1.2 versus 0.9; P < .001). In a subgroup with left ventricular ejection fraction < 45% (n = 49 patients; 24 on carvedilol and 25 on placebo), carvedilol showed attenuation of remodeling. CONCLUSIONS: Carvedilol was well tolerated and safe to use in patients immediately after AMI, including those with heart failure, and significantly improved outcome.

Administration, Oral↗

PubMed2026

Prevention of postpartum methamphetamine use with micronized progesterone trial (PROMPT): A pilot randomized controlled trial.

OBJECTIVES: Methamphetamine use disorder (MUD) contributes to postpartum morbidity and mortality. Postpartum progesterone decline may destabilize γ-aminobutyric acid pathways, increasing craving and return to use. We assessed the feasibility and safety of micronized progesterone, generating efficacy estimates for preventing postpartum methamphetamine use. METHODS: We conducted a double-blind, randomized, placebo-controlled feasibility trial (November 2021-January 2024) at an academic center with a perinatal addiction clinic. Participants ≤ 12 weeks postpartum with ≥ 4 weeks of abstinence were randomized 1:1, stratified by opioid use disorder (OUD), to micronized progesterone 400mg (200mg twice daily) or identical placebo for 12 weeks. The primary outcome was feasibility, defined as achieving ≥ 80% of planned enrollment. Safety outcomes included adverse events (AEs) and serious adverse events (SAEs). Efficacy outcomes were return to methamphetamine use (weekly self-report and every two weeks urine toxicology) and methamphetamine craving. Analyses included intent-to-treat and per-protocol approaches, with loss to follow-up imputed as return to use. Craving trajectories were modeled using adjusted regression with interaction terms for medication for OUD (MOUD). RESULTS: Of 253 screened individuals, 43 were eligible and 34 were enrolled (91.8%; 18 progesterone, 16 placebo). Retention at 12 weeks was 88%. AE frequency was similar between groups (78% vs 81%; p > 0.05), and no maternal SAEs occurred. Four infant SAEs were deemed unrelated to treatment. Return to methamphetamine use did not differ between groups. Craving trajectories differed by MOUD type. CONCLUSIONS: Micronized progesterone was feasible and safe for postpartum individuals with MUD. MOUD-specific craving effects support evaluation in larger, multicenter efficacy trials. GOV REGISTRATION NUMBER: NCT05128071 NCT REGISTRATION: Prevention of postpartum methamphetamine use with micronized progesterone trial https://clinicaltrials.gov/study/NCT05128071.

Humans↗

PubMed1998

Methylprednisolone or tirilazad mesylate administration after acute spinal cord injury: 1-year follow up. Results of the third National Acute Spinal Cord Injury randomized controlled trial.

OBJECT: A randomized double-blind clinical trial was conducted to compare neurological and functional recovery and morbidity and mortality rates 1 year after acute spinal cord injury in patients who had received a standard 24-hour methylprednisolone regimen (24MP) with those in whom an identical MP regimen had been delivered for 48 hours (48MP) or those who had received a 48-hour tirilazad mesylate (48TM) regimen. METHODS: Patients for whom treatment was initiated within 3 hours of injury showed equal neurological and functional recovery in all three treatment groups. Patients for whom treatment was delayed more than 3 hours experienced diminished motor function recovery in the 24MP group, but those in the 48MP group showed greater 1-year motor recovery (recovery scores of 13.7 and 19, respectively, p=0.053). A greater percentage of patients improving three or more neurological grades was also observed in the 48MP group (p=0.073). In general, patients treated with 48TM recovered equally when compared with those who received 24MP treatments. A corresponding recovery in self care and sphincter control was seen but was not statistically significant. Mortality and morbidity rates at 1 year were similar in all groups. CONCLUSIONS: For patients in whom MP therapy is initiated within 3 hours of injury, 24-hour maintenance is appropriate. Patients starting therapy 3 to 8 hours after injury should be maintained on the regimen for 48 hours unless there are complicating medical factors.

Activities of Daily Living↗

PubMed1997

Analysis of randomized controlled trials in laparoscopic surgery.

BACKGROUND: Randomized controlled studies of surgical procedures are difficult, but can be done to acceptable standards. There are few published objective assessments of such trials. METHODS: The original articles that involved a randomized controlled trial including at least one laparoscopic procedure were reviewed and evaluated with special interest in their methodology. An assessment form containing 11 generic questions and three additional criteria (assessment of quality of life, cost analysis and laparoscopic experience required) was used. Forty trials were retrieved including 12 on cholecystectomy, 12 on hernia repair and 12 on appendicectomy. Each trial was scored by two assessors. RESULTS: The agreement among the two independent assessors was very good. Six of the trials were well conducted but 22 had a poor score. The trials on cholecystectomy were scored the best in contrast to those on hernia repair or appendicectomy. Few trials provided an adequate prospective calculation of the sample size, an unbiased assessment of endpoints, evaluation of the quality of life and a study of the economic aspects. CONCLUSION: Readers should be cautious when interpreting the results of some of these trials and their impact on daily surgical practice.

Humans↗

PubMed1983

A double-blind randomized control trial of diazepam.

A double-blind randomized controlled trial of diazepam against placebo in the management of minor conditions seen in general practice demonstrated that administration of either diazepam or placebo was associated with a substantial reduction in symptomatology three weeks later. There was no demonstrable difference between diazepam and placebo.

Adult↗

PubMed1996

The Oxford Laser Prostate Trial: a double-blind randomized controlled trial of contact vaporization of the prostate against transurethral resection; preliminary results.

OBJECTIVE: To compare the results of contact laser vaporization and transurethral resection of the prostate (TURP) in a double-blind randomized controlled clinical trial. PATIENTS AND METHODS: The study comprised 148 patients with clinical benign prostatic hypertrophy (BPH) who were recruited and allocated randomly to undergo either TURP (72 patients) or laser ablation of the prostate (76 patients). The outcome was assessed using the American Urological Association (AUA -7) symptom score after 1 and 3 months as the primary measure and by urinary flow rates, haematological factors and the duration of hospital stay and length of catheterization. RESULTS: With 90% statistical power, the results at 3 months showed no clinical or statistical difference between the treatments in change in AUA symptom score. A lower blood loss, hospital stay and duration of catheterization significantly favoured the laser treatment, although the failure rate of trial without catheter and the rate of re-operation were higher after laser treatment. CONCLUSIONS: These early data are encouraging for this technique, although the outcome after one year requires evaluation before advocating the widespread uptake of this method.

Aged↗

PubMed1997

The AVID trial: evidence based or randomized control trials--is the AVID study too late? Antiarrhythmics Versus Implantable Defibrillators.

A great body of clinical evidence has been accumulated--before and without the AVID trial--showing that implantable defibrillators prolong life better than currently available antiarrhythmic drugs. With this evidence already available, we question the validity of a trial that attempted, in effect, to place a price tag on life and quality of life.

Anti-Arrhythmia Agents↗

PubMed1978

A randomized controlled trial of selective planned delivery.

A prospective randomized controlled trial designed to investigate selective planned delivery is reported: 264 obstetrically normal women in the 38th week of pregnancy were admitted to this trial and 184 completed it. The infants of mothers in the planned delivery group had higher serum bilirubin levels on the fifth day post partum than control infants but no baby required treatment for hyperbilirubinaemia. Mothers in the planned delivery group required significantly greater amounts of pethidine while control mothers had a significantly higher incidence of meconium staining of the amniotic fluid. However, the infants in the two groups had similar Apgar scores at birth. There was one stillbirth in the control group; this was due to unrecognized fetal hypoxia during labour induced at 42 weeks for postmaturity.

Apgar Score↗

PubMed1997

Improving cancer pain management in communities: main results from a randomized controlled trial.

The purpose of this randomized controlled community trial is to evaluate the effects of a community intervention utilizing opinion leaders and educational strategies on the cancer pain management knowledge, attitudes, and the practices of physicians and nurses, and cancer pain reported by patients. Six Minnesota communities participated in the study. The three communities randomized to the intervention received educational programs over 15 months. The clinical community opinion leaders participated in a minifellowship, developed community task forces, and interacted with their peers. This strategy was reinforced with community outreach programs, clinical practice guidelines, educational materials, and media events. The primary study end point was patients' pain intensity score. Comparing intervention to control communities, pain prevalence declined slightly, pain management index improved slightly, pain intensity scores increased slightly, patient and family attitude scores did not change, and physicians' and nurses' knowledge and attitude scores improved slightly. None of these changes, however, reached statistical significance. Participation in at least one intervention program improved physicians' and nurses' knowledge and attitude scores that approached statistical significance. Our results suggest that community opinion leaders combined with other educational programs may improve cancer pain management, but this strategy requires further study. The results suggest that more intense intervention application may be effective. Effective strategies to improve cancer pain management remain elusive.

Cohort Studies↗

PubMed1994

Patient education and health promotion can be effective in Parkinson's disease: a randomized controlled trial. PROPATH Advisory Board.

We performed a randomized controlled trial to evaluate the effectiveness of a patient education and health promotion program in the treatment of Parkinson's disease. The health promotion program (PROPATH) was designed to improve health confidence, provide information and support, improve physical function through exercise, and work with the physician to optimize medical treatment and compliance. The intervention was delivered by mail, with disease assessment questionnaires completed by patient or caregiver at 0, 2, 4, and 6 months, with computer-generated reports and individualized recommendation letters returned to patients and reports to physicians. Two hundred ninety patients completed the 6-month trial, 140 patients in the intervention group and 150 in a control group of patients who received only questionnaires. The intervention group had significantly increased exercise, decreased "time off" and percentage of time off, reduced side effects, and decreased summary Parkinson's scores by approximately 10% (P > 0.05). Twelve of 13 variables showed differences favoring the intervention group. The rate of progression of summary scores became essentially flat during the program for the intervention group and continued to rise sharply for controls (P > 0.01). Levodopa dose rose for controls and slightly decreased for the intervention group. Doctor visits, hospital days, and sick days were reduced in the intervention group. The quality-of-life assessment demonstrated improvement in patient global, self-efficacy scores, and spouse or caregiver assessments. We conclude that a low-cost patient education program provides a useful adjunct to medical therapy of Parkinson's disease, may reduce costs, and can improve intermediate term outcomes.

Activities of Daily Living↗

PubMed2000

A comparison of observational studies and randomized, controlled trials.

BACKGROUND: For many years it has been claimed that observational studies find stronger treatment effects than randomized, controlled trials. We compared the results of observational studies with those of randomized, controlled trials. METHODS: We searched the Abridged Index Medicus and Cochrane data bases to identify observational studies reported between 1985 and 1998 that compared two or more treatments or interventions for the same condition. We then searched the Medline and Cochrane data bases to identify all the randomized, controlled trials and observational studies comparing the same treatments for these conditions. For each treatment, the magnitudes of the effects in the various observational studies were combined by the Mantel-Haenszel or weighted analysis-of-variance procedure and then compared with the combined magnitude of the effects in the randomized, controlled trials that evaluated the same treatment. RESULTS: There were 136 reports about 19 diverse treatments, such as calcium-channel-blocker therapy for coronary artery disease, appendectomy, and interventions for subfertility. In most cases, the estimates of the treatment effects from observational studies and randomized, controlled trials were similar. In only 2 of the 19 analyses of treatment effects did the combined magnitude of the effect in observational studies lie outside the 95 percent confidence interval for the combined magnitude in the randomized, controlled trials. CONCLUSIONS: We found little evidence that estimates of treatment effects in observational studies reported after 1984 are either consistently larger than or qualitatively different from those obtained in randomized, controlled trials.

Bone Density↗

PubMed2000

Randomized, controlled trials, observational studies, and the hierarchy of research designs.

BACKGROUND: In the hierarchy of research designs, the results of randomized, controlled trials are considered to be evidence of the highest grade, whereas observational studies are viewed as having less validity because they reportedly overestimate treatment effects. We used published meta-analyses to identify randomized clinical trials and observational studies that examined the same clinical topics. We then compared the results of the original reports according to the type of research design. METHODS: A search of the Medline data base for articles published in five major medical journals from 1991 to 1995 identified meta-analyses of randomized, controlled trials and meta-analyses of either cohort or case-control studies that assessed the same intervention. For each of five topics, summary estimates and 95 percent confidence intervals were calculated on the basis of data from the individual randomized, controlled trials and the individual observational studies. RESULTS: For the five clinical topics and 99 reports evaluated, the average results of the observational studies were remarkably similar to those of the randomized, controlled trials. For example, analysis of 13 randomized, controlled trials of the effectiveness of bacille Calmette-Guérin vaccine in preventing active tuberculosis yielded a relative risk of 0.49 (95 percent confidence interval, 0.34 to 0.70) among vaccinated patients, as compared with an odds ratio of 0.50 (95 percent confidence interval, 0.39 to 0.65) from 10 case-control studies. In addition, the range of the point estimates for the effect of vaccination was wider for the randomized, controlled trials (0.20 to 1.56) than for the observational studies (0.17 to 0.84). CONCLUSIONS: The results of well-designed observational studies (with either a cohort or a case-control design) do not systematically overestimate the magnitude of the effects of treatment as compared with those in randomized, controlled trials on the same topic.

Anticholesteremic Agents↗

PubMed2000

How well are randomized controlled trials reported in the dermatology literature?

OBJECTIVE: To assess the methodological quality of the design and reporting of randomized controlled trials published in one major dermatology specialty journal. DESIGN AND DATA SOURCES: In a survey of all published parallel group randomized controlled trials, we found 73 reports with allocation described as randomized from all issues of Clinical and Experimental Dermatology from its inception in 1976 through 1997. MAIN OUTCOME MEASURES: Direct and indirect measures of the adequacy of randomization, trial sample size, baseline comparisons, and intention-to-treat analysis. RESULTS: Hand searching identified 73 randomized controlled trials, but only 31 of these were found by searching MEDLINE for the publication type clinical trials. Of the 73 randomized controlled trials, 68 contained sufficient information to include in the analysis. Only 1 study (1%) reported the method of random sequence generation, and only 5 studies (7%) reported adequate concealment of allocation. Among 38 trials that used simple randomization, the sample sizes in the comparison groups were identical in 22 occasions, raising the possibility that simple randomization might not have been adequately generated or concealed. Most trials (88%) excluded some randomized participants from their analysis. The median sample size was 23 per trial. Only 1 trial reported sample size and statistical power considerations and had an a priori main hypothesis. CONCLUSIONS: Hand searching is important for locating all relevant trials. There is the need for higher methodological quality in clinical trial reporting in dermatology journals. The adoption of the CONSORT (Consolidated Standards of Reporting Trials) statement and checklist for the reporting of trials should enhance the validity of and strengthen the evidence from clinical trials reports.

Data Collection↗

PubMed1994

Intrapartum chemoprophylaxis of perinatal group B streptococcal infections: a critical review of randomized controlled trials.

The purpose of this overview was to critically appraise all published randomized, controlled trials evaluating the efficacy of intrapartum chemoprophylaxis in reducing perinatal group B streptococcal infections. The Oxford Database of Perinatal Trials, Medline, Excerpta Medica, and personal files were used for the literature search. By means of present inclusion criteria to select relevant articles, two independent researchers identified nine randomized, controlled trials. Three trials were excluded because of duplicate publication, one because the randomization process was violated, and one because the outcome data were collected retrospectively. The quality of the methods of the four accepted trials was poor, and because of basic flaws meta-analyses of trial results were not performed. Results of three studies showed a statistically significant reduction in neonatal group B streptococcal colonization rates with intrapartum chemoprophylaxis. Although a trend toward a reduction in proved neonatal infection was reported in three studies, each lacked the power to reach statistical significance. Intrapartum chemoprophylaxis to reduce perinatal group B streptococcal infections is not supported by conclusive evidence from well designed and conducted randomized, controlled trials.

Bacteremia↗

PubMed1990

Primary prevention of Pneumocystis carinii pneumonia by inhalation of pentamidine. Preliminary results from a placebo-controlled randomized trial. Swiss Group for Clinical Studies on AIDS.

Patients with AIDS but without pneumocystis carinii pneumonia, patients with advanced AIDS-related complex (ARC), and asymptomatic patients with less than 200 CD4-positive lymphocytes/mm3 were randomized to one of two groups: group I: Inhalation of 300 mg of pentamidine every 28 days; group II: Inhalation of placebo (300 mg of Na isethionate) every 28 days. From May to November 28, 1989, 160 patients have entered the trial. Inhalations were well tolerated, with only a 6% use of bronchodilators and a 15% incidence of cough. Until now five patients died, none of them drug related. So far, six patients have developed pneumocystis carinii pneumonia; four of these were on pentamidine, and two on placebo. Five of the six cases occurred before the second inhalation. Recruitment will continue until 250 patients are enrolled.

Administration, Inhalation↗

PubMed1998

Natural beta interferon in acute type-C hepatitis patients: a randomized controlled trial.

AIM OF THE STUDY: A multicentre randomized controlled trial to assess whether a short course of beta-interferon could reduce the rate of chronic evolution of acute hepatitis C, in line with recent observations, was started in Northern Italy in 1991. METHODS: Forty acute hepatitis C patients were randomized to receive natural beta interferon 3,000,000 international units intramuscularly three times a week for 4 weeks or symptomatic drugs, and were followed up for a median period of 22.5 months. RESULTS: The chronicity rate was 75% (15/20 patients) in the interferon-treated group, and 80% (16/20) in the untreated group. No difference in the duration of the acute phase of hepatitis was observed. Hepatitis C virus ribonucleic acid was determined in 21 cases and was positive in 19 cases at baseline and in 15/17 chronic and 1/4 non chronic cases at the end of follow-up. Side effects of therapy (flu-like syndrome in 40% of cases) were mild and short-lasting. No aminotransferase flare-ups were observed during treatment. CONCLUSIONS: Beta interferon at the suggested regimen is well tolerated but does not seem to significantly influence the natural course of acute hepatitis C.

Acute Disease↗

PubMed1995

The type and quality of randomized controlled trials (RCTs) published in UK public health journals.

BACKGROUND: Randomized controlled trials (RCTs) are increasingly being used to evaluate the effectiveness of health care interventions. Systematic reviews of RCTs form the basis of the Cochrane Collaboration, which aims to synthesize all RCTs concerned with the provision of health care. This paper reports the quantity and methodological quality of RCTs published in five UK public health journals, which were searched as part of a planned register of RCTs in public health. METHODS: Five journals were hand searched: The International Journal of Epidemiology, Health Trends, Journal of Public Health Medicine, Public Health and The Journal of Epidemiology and Community Health. All RCTs were identified and their methodological characteristics reviewed. RESULTS: Ninety-one trials were identified from the five journals. A wide variety of topics were covered, the most common being prevention strategies )46 percent of the trials). Although the actual number of reports of RCTs published increased over time, there was no detectable improvement in the quality of reports. The aspect of bias most well controlled was control of bias at entry (randomization), in 83 (91 per cent) of trials. However, even in these trials details about the process of randomization were poor. CONCLUSION: These trials will form the basis of a register of RCTs in public health. The diversity of topics covered illustrates the broad-based nature of public health. For this reason, many other RCTs relevant to the practice of public health are likely to be found in non-public health journals.

Humans↗