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Results for “Randomized Controlled Trial”

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PubMed1992

Dexamethasone and bacterial meningitis. A meta-analysis of randomized controlled trials.

A meta-analysis of 5 randomized, controlled trials using dexamethasone as adjunctive therapy in the treatment of bacterial meningitis in children was done to assess the efficacy in reducing sequelae. A 6th study including both children and adults was analyzed separately. Results of the 5 pediatric studies indicated no significant difference in case-fatality rate between the placebo and dexamethasone groups. Significantly more neurologic sequelae were found in the placebo group during the period from discharge from hospital to 6 weeks after discharge (relative risk [RR] = 1.99, 95% confidence interval [CI] 1.13 to 3.53) and during the period beginning 6 months after discharge (RR = 3.90, 95% CI 1.72 to 8.85). The incidence of neurologic sequelae from 6 weeks to 6 months after discharge, though less with dexamethasone administration, did not reach statistical significance. The frequency of bilateral hearing loss was significantly greater in the placebo group (RR = 4.12, 95% CI 1.74 to 9.79), but unilateral loss was not statistically different in the two groups. Dexamethasone administration in addition to antimicrobial therapy appears to be effective in reducing neurologic sequelae and bilateral hearing loss associated with bacterial meningitis in children.

Adult↗

PubMed1978

The importance of beta, the type II error and sample size in the design and interpretation of the randomized control trial. Survey of 71 "negative" trials.

Seventy-one "negative" randomized control trials were re-examined to determine if the investigators had studied large enough samples to give a high probability (greater than 0.90) of detecting a 25 per cent and 50 per cent therapeutic improvement in the response. Sixty-seven of the trials had a greater than 10 per cent risk of missing a true 25 per cent therapeutic improvement, and with the same risk, 50 of the trials could have missed a 50 per cent improvement. Estimates of 90 per cent confidence intervals for the true improvement in each trial showed that in 57 of these "negative" trials, a potential 25 per cent improvement was possible, and 34 of the trials showed a potential 50 per cent improvement. Many of the therapies labeled as "no different from control" in trials using inadequate samples have not received a fair test. Concern for the probability of missing an important therapeutic improvement because of small sample sizes deserves more attention in the planning of clinical trials.

Clinical Trials as Topic↗

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↗

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↗

PubMed1978

Prevention of deep vein thrombosis in neurosurgical patients: a controlled, randomized trial of external pneumatic compression boots.

A prospective, randomized clinical trial in 95 patients undergoing neurosurgical operative procedures was performed to investigate the efficacy of external pneumatic compression (EPC) of the calves as compared with results in a control group that received no specific form of prophylaxis for prevention of deep vein thrombosis (DVT). The diagnosis of DVT was established by the I125 fibrinogen scan and radiographic contrast phlebography. The data indicate that EPC provides significant protection against the development of DVT in comparison with results in the control group (p less than 0.005). There were no known pulmonary emboli in any of the EPC-treated patients. There were no complications of EPC.

Evaluation Studies as Topic↗

PubMed1992

Adenosine during cardiac arrest and cardiopulmonary resuscitation: a placebo-controlled, randomized trial.

UNLABELLED: BACKGROUND AND HYPOTHESIS TESTED: The effects of adenosine (100 micrograms/kg/min; n = 7) were examined during rodent cardiopulmonary resuscitation (CPR). Change in coronary artery perfusion pressure, end-tidal PCO2, and arterial acid-base status of anesthetized, male, Sprague-Dawley rats were compared with CPR controls (0.9% sodium chloride; n = 7) and with sham controls (n = 9). Sustained ventricular fibrillation was induced and precordial chest compression was followed by defibrillation. RESULTS: After 6 mins of cardiac arrest, six (86%) of seven adenosine-treated animals were resuscitated after adenosine infusion and four (57%) of seven control animals were resuscitated after sodium chloride infusion. During chest compression, coronary artery perfusion pressure was 7 +/- 2 mm Hg after adenosine, but was 22 +/- 3 mm Hg in the controls (p less than .01). Parallel decreases were observed in mean aortic pressure. Arterial and end-tidal PCO2 significantly (p less than .01) decreased after adenosine. These changes contrasted with a second control group of nine identically prepared animals which, in the absence of ventricular fibrillation and subsequent chest compression, demonstrated no changes in hemodynamic, respiratory, or blood gas variables. CONCLUSIONS: Adenosine decreased coronary artery perfusion pressure. However, despite marked reductions in coronary artery perfusion pressure, survival was not compromised after adenosine infusion in this rodent model of CPR.

Acid-Base Equilibrium↗

PubMed1992

Randomized, controlled trial of compression gloves in rheumatoid arthritis.

A randomized, controlled trial was conducted to determine efficacy of the Isotoner and the Futuro compression gloves in 39 patients with hand synovitis secondary to rheumatoid arthritis. After 7 days of nighttime treatment, both brands of gloves were found to decrease subjective symptoms of pain and stiffness (p < 0.05). In addition, swelling of the proximal interphalangeal joints decreased, while range of motion, rate of finger motion, and grip strength all increased (p < 0.05). Compression gloves should be used with caution in patients with bilateral carpal tunnel syndrome, because 12 of 13 such patients experienced worsening of their symptoms following one nighttime wearing of compression gloves. While both gloves were found to be efficacious in improving the signs and symptoms of hand synovitis, neither glove was found to be superior to the other. Patient preferences related to glove composition and fit may ultimately determine which glove to prescribe.

Adult↗

PubMed1992

Geriatric follow-up by home visits after discharge from hospital: a randomized controlled trial.

The aim of this prospective, randomized and controlled trial was to carry out and evaluate a model for follow-up by home visits after discharge from hospital of persons aged 75 years or more. The trial was a feasibility study in which hospital staff, district nurses, and general practitioners already working within the hospital and the primary health sector participated, with changes in the usual organization. On the day after their discharge from hospital, 163 patients were visited in their homes by the district nurse. Two weeks later, they were evaluated at home by their general practitioner. For 181 control patients, discharge took place according to the usual procedures. Endpoints were evaluated one year after discharge. Significantly more patients from the control group had been admitted to nursing homes as compared with the trial group (25/10, p < 0.05); the control patients stayed 2700 days at institutions, the trial group 1950 days. It is proposed that this simple and practicable follow-up routine be introduced in connection with discharge of elderly persons from hospital.

Aged↗

PubMed1979

Randomized controlled trial of cefuroxime for established postoperative respiratory infection.

A randomized controlled trial has investigated the value of cefuroxime (a new antibiotic resistant to beta-lactamase) in 80 patients with established postoperative respiratory infection. Although the majority of respiratory isolates were sensitive to cefuroxime, there was no significant advantage in the antibiotic group compared with the controls with respect to duration of fever, radiological abnormality or infected sputum. We conclude that antibiotics are rarely necessary for the majority of patients who develop postoperative respiratory infections.

Cephalosporins↗

PubMed1978

Results of a controlled randomized trial of proximal gastric vagotomy with and without pyloroplasty.

The 1--5 year results of a prospective randomized trial of proximal gastric vagotomy (PGV) with and without pyloroplasty in 64 men operated upon electively for chronic duodenal ulcer are reported. The effects of the operation on gastric secretion, as tested at 6 months with pentagastrin and isulin, were the same in both groups. There was no statistically significant difference in the clinical results between the two groups. The authors conclude that the addition of pyloroplasty makes little, if any, difference to the results of PGV. Pyloroplasty is thus better omitted as it adds nothing of value and may increase the risk of the procedure.

Adult↗

PubMed1978

Adjuvant chemotherapy in large-bowel cancer: demonstration of effectiveness of single agent chemotherapy in a prospectively controlled,, randomized trial.

In a prospectively randomized study, the effect of adjuvant chemotherapy with 5-FU on survival and recurrence rates was analyzed in 299 evaluable patients with colorectal carcinoma who either underwent a curative or a palliative resection. In the treatment group, chemotherapy consisted of the intravenous administration of 12 mg/kg daily of 5-FU for 4 consecutive days, then 6 mg/kg on alternate days, to the point of toxicity, or to a maximum of five doses, followed by 12mg/kg weekly for 1 year. Some degree of drug toxicity was seen in the majority of patients, was rarely severe, and there have been no drug-related deaths. Analysis of the survival curves and disease-free interval curves reveal definite evidence of drug benefit in two unfavorable subgroups, namely patients with Dukes C tumors and in patients whose tumor was located in the rectum. In the chemotherapy groups, patients who were treated to toxicity (WBC less than 4000 mm3), the disease-free interval was significantly longer than the nonleukopenic patients. We conclude that the addition of 5-FU to the surgical treatment of colorectal carcinoma provides a small, but significant benefit in patients with colorectal cancer in certain unfavorable subgroups, namely patients with Dukes C lesions and patients with rectal carcinoma.

Clinical Trials as Topic↗

PubMed1975

Chemotherapy of advanced breast cancer: a controlled randomized trial of cyclophosphamide versus a four-drug combination.

Ninety-nine patients with advanced breast cancer were randomized to receive either cyclophosphamide continuously or a combination of cyclophosphamide, methotrexate, 5-fluorouracil and vinblastine given intermittently. The number and duration of objective responses were greater in patients receiving the combination but the differences between the two treatments did not achieve formal significance. The combination was logistically easier to manage and produced less toxicity.

Adult↗

PubMed2026

Assessment of blinding in pharmacotherapy and noninvasive neuromodulation randomized controlled trials for neuropathic pain in adults.

In randomized controlled trials (RCTs), study participants and research personnel are often blinded to minimize biases related to knowing treatment allocation. To determine if blinding was effective, participants may be asked which treatment they believe they received ("treatment guess"). This descriptive review characterized blinding assessment (BA) reporting in pharmacotherapy and neuromodulation neuropathic pain RCTs. Of 288 papers, 36 (12.5%) reported a BA. One paper reported the results of 2 studies, so in total 37 studies with a BA were assessed. Of these, 19 were crossover, 17 parallel, and 1 partial crossover in design. All 37 studies assessed participant blinding, and 10 also assessed investigator blinding. Approximately 27% included an "unsure" answer option for treatment guess, and 38% asked the reason for the guess. There were no clear patterns in BA reporting across time nor based on treatment type. Seventeen trials provided sufficient data to calculate Bang Blinding Index (BI) to determine blinding success. Participants remained blinded (BI = 0 ± 0.2) in 10/17 placebo and 10/17 treatment arms, 6 placebo and 5 treatment arms had a BI > 0.2 suggesting possible unblinding, whereas 1 placebo and 2 treatment arms had a BI < -0.2 suggesting misinformed guessing. Overall, we found that BAs are done in a minority of published neuropathic pain trials and with variable methodology. Given the importance of minimizing risk of bias because of treatment unblinding, future studies should consider including BAs, and further consensus building is necessary to determine if and how BAs should be conducted and interpreted in analgesic clinical trials.

Bias↗

PubMed1978

Prevention of deep vein thrombosis in urological patients: a controlled, randomized trial of low-dose heparin and external pneumatic compression boots.

A prospective, randomized clinical trial in 83 patients undergoing open urological operations was performed to compare the relative prophylactic efficacy of low-dose heparin and external pneumatic compression (EPC) of the calves in comparison to no treatment in the prevention of deep vein thrombosis (DVT). The diagnosis of deep vein thrombosis was established by the I125 fibrinogen scan and contrast phlebography. The data indicate that EPC is more effective than no treatment (p less than 0.04) and more effective than low-dose heparin (p less than 0.04) in the prevention of DVT. There was one pulmonary embolus in each of the three groups, and in the treatment groups this occurred without evidence of DVT.

Adult↗

PubMed1979

A randomized controlled trial of geriatric screening and surveillance in general practice.

A randomized controlled trial of geriatric screening and surveillance was undertaken on a practice population of 295 patients aged 70 years or more over a two-year period. In the screened group (145 patients) many social problems were found and a total of 380 medical conditions were reported during the study period, 144 (38 per cent) of which were previously undetected. Conditions found most frequently involved the circulatory, musculoskeletal and nervous systems; 67 per cent of the conditions found were manageable, half being improved and the remainder resolved completely.The screening programme was found to increase the use of social and health services but it did also decrease the expected duration of stay in hospital.Independent assessment of patients in the study and control groups at the end of the two-year period showed that the screening programme had made no significant impact on the prevalence of socio-economic, functional, and medical disorders affecting health.We formed the firm impression that the study patients were made more comfortable (by control of pain) and less disabled, although there was no unequivocal objective evidence of this. They were, however, kept independent for longer.The findings are discussed and a model of geriatric care is suggested combining conventional management on demand with comprehensive screening to identify the high-risk patients on whom care might need to be focussed.

Aged↗

PubMed1992

[Reappraisal of Zelen's method in randomized controlled trials].

This paper discusses Zelen's method (a study design with pre-randomization) in randomized controlled trials from the following aspects: 1) compliance of patients with a randomly assigned treatment; 2) infringement of patients' right to choose treatments; and 3) unfairness that only patients assigned to a new treatment are allowed a choice of treatments. The reason Zelen's method is rarely used in the United States or European countries seems to be the lower compliance of treatments in Zelen's method than in the conventional design of randomized controlled trials. Considering the present study practice in Japan, where study subjects are not completely informed by randomized assignment of treatments, Zelen's method is thought to be more practical, and not inferior to the conventional design in terms of compliance.

Humans↗

PubMed2026

Impact of kangaroo care on circadian rhythm, growth, physiological stability in premature infants, and cortisol and melatonin levels in maternal breast milk: A randomized controlled trial.

PURPOSE: This study aimed to examine the effects of regular kangaroo care (KC) on sleep-wake cycles, growth, physiological stability, and maternal breast milk cortisol and melatonin levels in premature infants. DESIGN: This study was a parallel group, single-blind, pre-test-post-test, randomised controlled trial (RCT). METHODS: This randomized controlled study was conducted in a neonatal intensive care unit (NICU) in Türkiye between September 2024 and September 2025 Thirty-six premature infants were randomized to intervention (n = 28) or control (n = 28). Infants in the intervention group received KC for three consecutive days, twice daily (10:00 a.m. and 10:00 p.m.) for 60 min per session. Data were collected using the Infant Information Form, Physiological Parameters Monitoring Chart, and Premature Infant Sleep-Wake Cycles Tracking Chart. Sleep-wake cycles were monitored using a Bispectral Index device. Breast milk cortisol and melatonin levels were measured at baseline and on day three using the competitive ELISA method. The study was registered at ClinicalTrials.gov (NCT06589349). RESULTS: Regular KC had a statistically significant effect on BIS values, heart rate, respiratory rate, oxygen saturation, and body temperature (p < 0.05). No statistically significant effects were observed on infant body weight or on maternal breast milk cortisol and melatonin levels (p > 0.05). CONCLUSION: The findings indicate that regular KC is associated with improved regulation of the sleep-wake cycle and enhanced physiological stability in premature infants. No significant changes were observed in maternal breast milk cortisol or melatonin levels following KC.

Humans↗

PubMed1977

Randomized controlled trial of early discharge for inguinal hernia and varicose veins.

A randomized controlled trial has been conducted into the effects of discharging patients from hospital either at 48 h or 6-7 days after operation for inguinal hernia or varicose veins. There was no statistically significant difference in the frequency of major postoperative complications between the two lengths of stay for either of the conditions studied. Similarly there was no difference between the two groups of hernia patients in relation to eventual recurrences.

Clinical Trials as Topic↗