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Results for “Randomized controlled trials”

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At least 361 records · Page 20Linked 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↗

PubMed2006

Short-term efficacy of intravenous pulse glucocorticoids in acute discogenic sciatica. A randomized controlled trial.

STUDY DESIGN: Double-blinded randomized controlled trial. OBJECTIVE: To test the short-term efficacy of a single intravenous (IV) pulse of glucocorticoids on the symptoms of acute discogenic sciatica. SUMMARY OF BACKGROUND DATA: The use of glucocorticoids in the treatment of acute discogenic sciatica is controversial. A potential advantage of the IV pulse therapy is the ability to distribute high glucocorticoid concentrations to the area surrounding the prolapsed disc without the risks and inconveniences of an epidural injection. METHODS: Patients with acute sciatica (<6-week duration) of radiologically confirmed discogenic origin were randomized to receive either a single IV bolus of 500 mg of methylprednisolone or placebo. Clinical evaluation was performed in a double-blind manner on days 0, 1, 2, 3, 10, and 30. The primary outcome was reduction in sciatic leg pain during the first 3 days following the infusion; secondary outcomes were reduction in low back pain, global pain, functional disability, and signs of radicular irritation. The analysis was performed on an intent-to-treat basis using a longitudinal regression model for repeated measures. RESULTS: A total of 65 patients were randomized, and 60 completed the treatment and the follow-up assessments. A single IV bolus of glucocorticoids provided significant improvement in sciatic leg pain (P = 0.04) within the first 3 days. However, the effect size was small, and the improvement did not persist. IV glucocorticoids had no effect on functional disability or clinical signs of radicular irritation. CONCLUSIONS: Although an IV bolus of glucocorticoids provides a short-term improvement in leg pain in patients with acute discogenic sciatica, its effects are transient and have small magnitude.

Double-Blind Method↗

PubMed2006

[The term breech trial: the rise and fall of a randomized controlled trial--a critical survey].

Six years after publication of the results of the first international randomized controlled trial with the main question which mode of delivery is the best for term breech babies, there are increasing concerns about the validity of the study data concluding caesarean delivery was safer for breech babies. In January 2006 published article in the American Journal of Obstetrics and Gynecology the data of the study has been analysed again. The author comes to the conclusion that because of mistakes in the study design the results are unreliable and that the study group should withdraw the recommendations. Furthermore in his article he quotes from the study and emphasizes the mistakes.

Breech Presentation↗

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↗

PubMed2005

Effect of oral contraceptive pill pretreatment on ongoing pregnancy rates in patients stimulated with GnRH antagonists and recombinant FSH for IVF. A randomized controlled trial.

BACKGROUND: The objective of this randomized controlled trial was to assess the effect of oral contraceptive pill (OCP) pretreatment on the probability of ongoing pregnancy in patients treated with a GnRH antagonist for IVF. METHODS: A fixed dose of 200 IU recombinant FSH (rFSH) was started in 425 patients either on day 2 of the menstrual cycle (non-OCP group: n = 211) or 5 days after discontinuing the OCP (OCP group: n = 214). GnRH-antagonist was initiated on day 6 of stimulation, and triggering of final oocyte maturation was performed with 10,000 IU of HCG. RESULTS: Ongoing pregnancy rates per started cycle in the non-OCP and OCP group were 27.5% and 22.9%, respectively [95% confidence interval (CI) of the difference: -3.7 to +12.8]. Pregnancy loss was significantly increased in the OCP (36.4%) compared with the non-OCP group (21.6%) (95% CI of the difference: -28.4 to -2.3). CONCLUSION: Pretreatment with OCP, as compared with initiation of stimulation on day 2 of the cycle in patients treated with GnRH antagonist and recombinant FSH, appears to be associated with a not significant difference in ongoing pregnancy rates per started cycle and results in a significantly higher early pregnancy loss.

Adult↗

PubMedDate not supplied

A pilot randomized controlled trial of dexamphetamine in patients with chronic fatigue syndrome.

This study determined whether dexamphetamine improved symptoms and quality of life in patients with chronic fatigue syndrome. The setting was a specialized clinic within a tertiary referral hospital. This was a 6-week parallel-group, placebo-controlled trial with random allocation. There was a 2-week dose-adjustment phase and a 4-week stable treatment period. Outcome measures were the Fatigue Severity Scale, the Medical Outcomes Study 36-item Short-Form Health Survey, and two patient-determined outcomes. Ten patients were randomly assigned to dexamphetamine, and 10 were assigned to placebo. Fatigue Severity Scale scores improved in nine of 10 dexamphetamine and four of 10 placebo patients. The change in mean score was statistically significant. There were large but statistically nonsignificant changes in scores for the Short-Form Health Survey domains vitality and physical functioning. Dexamphetamine may be useful in the management of chronic fatigue syndrome; a larger and longer trial is justified by these results.

Adolescent↗

PubMed2004

Sapporo Fitness Club Trial (SFCT)--design, recruitment and implementation of a randomized controlled trial to test the efficacy of exercise at a fitness club for the reduction of cardiovascular risk factor--.

BACKGROUND: The annual health check followed by lifestyle recommendations has long been the standard national strategy to improve cardiovascular disease (CVD) risk factors in Japan. Exercise at fitness clubs, now widely accessible in major cities, has a novel appeal as a strategy with the additive effect of CVD risk reduction. The Sapporo Fitness Club Trial (SFCT) is a randomized controlled trial to compare the efficacy of the national standard alone (control) with the standard plus exercise at a fitness club (intervention) for the reduction of CVD risk factors. METHODS: The SFCT has recruited and randomized 561 relatively inactive overweight men and women, aged 40-85 years, with elevated levels of 2 or more of the following: systolic blood pressure, fasting blood glucose, and low-density lipoprotein cholesterol. The intervention group was required to exercise at a fitness club 2-4 times per week. At the end of 6 months, risk factors, aerobic capacity, health-related quality of life measures, and adverse effects are to be compared. CONCLUSION: The SFCT is expected to have a major impact in Japan on public health recommendations on exercise for the reduction of lifestyle-related disease.

Adult↗

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↗

PubMed2006

Pennsaid therapy for osteoarthritis of the knee: a systematic review and metaanalysis of randomized controlled trials.

OBJECTIVE: To systematically review published randomized controlled trials (RCT) evaluating a new topical diclofenac solution (Pennsaid) in patients with osteoarthritis (OA) of the knee. METHODS: RCT were identified by searching electronic data sources as well as by contact with the manufacturer of Pennsaid. Details of study demographics, methodology, quality, and outcomes were analyzed. A metaanalysis evaluating the efficacy and safety of Pennsaid in OA of the knee was performed. RESULTS: Four RCT were analyzed in this systematic review (3 published reports and one published abstract). Mean trial duration was 8.5 weeks. Generally, these RCT were of excellent quality. The mean Jadad quality score was 4.5 out of 5. Many indicators of high quality in a RCT were found in these RCT, including adequate descriptions of the methods used for randomization, blinding, and allocation concealment. In comparison to a vehicle control placebo (VCP), the standardized mean differences (SMD) for the WOMAC pain, stiffness, and physical function subscales, as well as for patient global assessment, were all statistically significant in favor of Pennsaid, with SMD ranging from 0.30 to 0.39. Pennsaid was as safe as VCP, with the only exception that it was more likely to result in minor skin dryness at the site of application (relative risk 1.7). In a 12 week equivalence trial that used the WOMAC subscales to compare treatment response, Pennsaid was as effective as oral diclofenac, but was much better tolerated. CONCLUSION: Pennsaid is an effective topical NSAID in patients with OA of the knee. Apart from minor localized skin reactions, Pennsaid was as safe as VCP. It is not known whether the favorable results of Pennsaid can be extrapolated to other topical NSAID preparations. Pennsaid deserves further consideration when the existing treatment guidelines for OA of the knee are updated.

Administration, Topical↗

PubMed2005

A sensitivity analysis of a randomized controlled trial of zinc in treatment of falciparum malaria in children.

BACKGROUND: The randomized trial has long been recognized as a means to assess the efficacy of new interventions, because the investigator can reduce or eliminate many sources of error. As such, clinical trials often do not include quantitative assessments of the extent that systematic error could affect their results. We examined the impact of different sources of bias on a randomized controlled trial of the efficacy of zinc as an adjuvant to malaria therapy in reducing time to total parasite clearance. METHODS: Using data from a previously published study, we identified two sources of bias and used the sensitivity analysis technique developed by Lash and Fink to assess the impact of each source of bias on the outcome. RESULTS: After correcting for each source of bias and reincorporating random error into our results, the point estimate of effect comparing those who received placebo to those who received zinc changed slightly (SMR changed from 0.92 to 0.90) but the 95% interval increased 22% (changing from 0.73-1.16 in the conventional analysis to 0.65-1.26 in the sensitivity analysis). CONCLUSIONS: The findings of this sensitivity analysis serve as a reminder that the frequentist confidence interval underestimates the total error, even in a randomized controlled trial. Authors of randomized controlled trial investigations ought to conduct a complete assessment of the impact of potential sources of bias in their studies. CONSORT guidelines for reporting trial results should be updated to encourage authors to assess the impact of non-random errors on their studies.

Antimalarials↗

PubMed2005

Recruitment of Medicaid and dual-enrolled Medicare beneficiaries with diabetes mellitus into a randomized controlled trial.

OBJECTIVE: To document the recruitment of Medicaid and dual-enrolled Medicare beneficiaries with diabetes mellitus into a randomized clinical trial. STUDY DESIGN: Randomized controlled trial with 1-year follow-up. METHODS: A total of 2242 Medicaid or dual-enrolled Medicare beneficiaries with diabetes residing in King County, Washington, were recruited by direct mail for a clinical trial of diabetes self-care management. Washington State Medicaid program databases were used to identify the target population who received recruitment packets from the program director. Individuals who did not return a participation refusal letter were telephoned to determine study eligibility. Subjects were screened during a study visit, and written informed consent was obtained. Enrolled subjects were randomized to a self-care intervention group or a usual care group. RESULTS: Of 2242 recruitment packets sent, we were unable to contact 40% of the target population, despite the fact that packets were sent to the same mailing addresses used for monthly Medicaid check distributions. The primary recruitment challenges were missing telephone contact information and a lack of interpreters speaking needed dialects. Of the 146 subjects enrolled, 71% were nonwhite, 28% were non-English speaking, 69% were women, and the mean age was 59.8 years. CONCLUSIONS: Research in Medicaid and Medicare populations is possible but requires additional time, energy, and resources. The finding that 40% of the Medicaid population could not be contacted suggests that Medicaid may want to revisit their contact information procedures to facilitate case management and other programs.

Aged↗

PubMed2004

Antidepressants for bipolar depression: a systematic review of randomized, controlled trials.

OBJECTIVE: This study reviewed the evidence from randomized, controlled trials on the efficacy and safety of antidepressants in the short-term treatment of bipolar depression. METHOD: The authors performed a systematic review and meta-analysis of randomized, controlled trials. They searched the Cochrane Collaboration Depression, Anxiety, and Neurosis Controlled Trials Register, incorporating results of searches of MEDLINE, EMBASE, CINAHL, PsycLIT, PSYNDEX, and LILACS. The main outcome measures were the proportion of patients who clinically responded to treatment and the rate of switching to mania. RESULTS: Twelve randomized trials were included, with a total of 1,088 randomly assigned patients. Five trials compared one or more antidepressants with placebo: 75% of these patients were receiving a concurrent mood stabilizer or an atypical antipsychotic. Antidepressants were more effective than placebo. Antidepressants did not induce more switching to mania (the event rate for antidepressants was 3.8% and for placebo, it was 4.7%). Six trials allowed comparison between two antidepressants. The rate of switching for tricyclic antidepressants was 10%, and for all other antidepressants combined, it was 3.2%. CONCLUSIONS: Antidepressants are effective in the short-term treatment of bipolar depression. The trial data do not suggest that switching is a common early complication of treatment with antidepressants. It may be prudent to use a selective serotonin reuptake inhibitor or a monoamine oxidase inhibitor rather than a tricyclic antidepressant as first-line treatment. Given the limited evidence, there is a compelling need for further studies with longer follow-up periods and careful definition and follow-up of emerging mania and partial remission.

Adult↗

PubMed2002

A review of randomized controlled trials using therapeutic apheresis.

Apheresis has developed into a common therapeutic modality. The evidence for the clinical benefit of apheresis, however, is generally from uncontrolled and nonrandomized trials. Although the effectiveness of therapeutic apheresis may be established from uncontrolled trials, well-designed, randomized controlled trials provide the best evidence for a clinical benefit because this type of trial design minimizes bias. We assess the evidence for the use of apheresis, the optimal schedules for apheresis, and the replacement solutions used, based on randomized controlled trials. The databases, MEDLINE and EMBASE, and reference lists from relevant articles were searched. The literature search was restricted to articles published in English and included adult patients only. Two of the authors (NS, CK) independently reviewed the citation list to identify reports for retrieval, and the kappa statistic was used to quantify agreement between the reviewers. Articles were included if they used apheresis as an intervention and had clinical endpoints. The quality of the studies was assessed by using a validated instrument. Five hundred and ninety-two citations were identified, and a total of 85 reports were included in this review. There are only a few well-established indications for therapeutic apheresis. Randomized, controlled trials have clearly shown a benefit for patients treated with apheresis who have Guillain-Barre syndrome and patients who have thrombotic thrombocytopenic purpura. A clinical benefit has not been shown for a variety of conditions, including systematic lupus erythematosus, polyarteritis nodosa/Churg-Strauss syndrome, and for the treatment of renal allograft rejection. The effectiveness of apheresis needs to be clarified for several other diseases. As better-designed, randomized trials are performed, the role of apheresis for these indications will be further elucidated.

Blood Component Removal↗

PubMed2006

Quality of reporting of randomized, controlled trials in cerebral palsy.

OBJECTIVES: In conducting reviews on the effectiveness of physiotherapy interventions on children with cerebral palsy, the assessment of trials can be hampered by problems in reporting. Therefore, we set out to evaluate trial reporting by using the Consolidated Standards of Reporting Trials (CONSORT) statement recommendations. METHODS: Randomized, controlled trials published in 1990 or later were identified in literature searches for reviews on the effectiveness of physiotherapy interventions on children with cerebral palsy. Two independent reviewers evaluated the trial reporting by using a modified 33-item Consolidated Standards of Reporting Trials checklist. RESULTS: We identified 15 randomized, controlled trials. Almost half (48%) of the applicable items were reported adequately. Inadequate reporting was found in the following items: outcome measures, sample-size determination, details of the sequence generation, allocation concealment and implementation of the randomization, success of assessor blinding, recruitment and follow-up dates, intention-to-treat analysis, precision of the effect size, co-interventions, and adverse events. CONCLUSIONS: Only a small number of sufficiently reported trials were found. Because nearly all items had been described in at least 1 article, high-quality reporting seems feasible. Assessment of trials depends on appropriate reporting, and poor reporting jeopardizes judgments on the clinical implications. Authors of randomized, controlled trials are encouraged to follow the Consolidated Standards of Reporting Trials criteria. There is a clear need to improve the quality of reporting of trials in this field.

Cerebral Palsy↗

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↗