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Results for “Randomized controlled trial”

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PubMed1995

Comparison of dynamic hip screw and gamma nail: a prospective, randomized, controlled trial.

We report a prospective, randomized, controlled trial, comparing the results of treatment with a dynamic hip screw (DHS) and a gamma nail in 95 consecutive patients with peri-trochanteric fractures of the femur. The DHS was used in 48 patients, the gamma nail in 47. Clinical and radiological outcomes were similar, but the gamma nail was associated with a higher incidence of complications, in particular fracture of the femur below the implant in eight cases. This is consistent with previous reports, and we do not recommend the gamma nail for the treatment of peri-trochanteric femoral fractures.

Aged↗

PubMed1998

Comparison of AIK-C measles vaccine in infants at 6 months with Schwarz vaccine at 9 months: a randomized controlled trial in Ghana.

In a randomized controlled trial in a measles endemic area, standard-dose (4.0 log10pfu) AIK-C measles vaccine administered at 6 months of age was compared to standard-dose Schwarz vaccine (3.7log10pfu) given at 9 months. Seroconversion rates at 3 and 6 months after immunization in the two groups were comparable and similar. The geometric mean titres achieved were, however, significantly higher in the Schwarz group (P < 0.05). No immediate serious side-effects were observed with either vaccine. We conclude that standard-dose AIK-C measles vaccine can be recommended for measles immunization in children below 9 months of age, especially in highly endemic and high-risk areas in developing countries.

Age Factors↗

PubMed1998

Kangaroo mother care for low birthweight infants: a randomized controlled trial in different settings.

A randomized controlled trial was carried out for 1 y in three tertiary and teaching hospitals, in Addis Ababa (Ethiopia), Yogyakarta (Indonesia) and Merida (Mexico), to study the effectiveness, feasibility, acceptability and cost of kangaroo mother care (KMC) when compared to conventional methods of care (CMC). About 29% of 649 low birthweight infants (LBWI; 1000-1999 g) died before eligibility. Of the survivors, 38% were excluded for various reasons, 149 were randomly assigned to KMC (almost exclusive skin-to-skin care after stabilization), and 136 to CMC (warm room or incubator care). There were three deaths in each group and no difference in the incidence of severe disease. Hypothermia was significantly less common in KMC infants in Merida (13.5 vs 31.5 episodes/100 infants/d) and overall (10.8 vs 14.6). Exclusive breastfeeding at discharge was more common in KMC infants in Merida (80% vs 16%) and overall (88% vs 70%). KMC infants had a higher mean daily weight gain (21.3 g vs 17.7 g) and were discharged earlier (13.4 vs 16.3 d after enrolment). KMC was considered feasible and presented advantages over CMC in terms of maintenance of equipment. Mothers expressed a clear preference for KMC and health workers found it safe and convenient. KMC was cheaper than CMC in terms of salaries (US$ 11,788 vs US$ 29,888) and other running costs (US$ 7501 vs US$ 9876). This study confirms that hospital KMC for stabilized LBWI 1000-1999 g is at least as effective and safe as CMC, and shows that it is feasible in different settings, acceptable to mothers of different cultures, and less expensive. Where exclusive breastfeeding is uncommon among LBWI, KMC may bring about an increase in its prevalence and duration, with consequent benefits for health and growth. For hospitals in low-income countries KMC may represent an appropriate use of scarce resources.

Breast Feeding↗

PubMed1998

The clinical utility of randomized controlled trials.

OBJECTIVE: Efficacy studies using randomized controlled trials (RCTs), on which empirically supported treatments are based, are often rejected as having little if any relevance to clinical practice. RCTs are faulted for allegedly excluding poor prognosis patients and therapists and treatments that are unrepresentative of clinical practice. METHODS: Evidence on the generalizability of findings from RCTs to diverse patient populations, different therapists, and varied clinical settings is critically evaluated. RESULTS: Existing research indicates that RCTs commonly include patients with multiple problems and levels of disturbance as severe as patients in clinical settings. DISCUSSION: The applicability of the findings of RCTs to clinical practice will be a changing function of the nature of the particular study and clinical setting to which the results are to be generalized. Future research should address the clinical utility of the findings of efficacy studies across different patient populations, therapists, and treatment methods.

Bulimia↗

PubMed1992

The effect of 17 alpha-hydroxyprogesterone caproate/oestradiol valerate on the development and outcome of early pregnancies following in vitro fertilization and embryo transfer: a prospective and randomized controlled trial.

A prospective and randomized study was performed to investigate the effect of supportive hormones on the development and outcome of early pregnancies following in vitro fertilization and embryo transfer. Immediately after pregnancies were confirmed endocrinologically on day 15 after oocyte collection, 17 alpha-hydroxyprogesterone caproate and oestradiol valerate (PC/EV) was administered to half of the patients in a randomly controlled trial. One group received supportive treatment until the twelfth week of gestation, whereas the other group received no treatment at all. Both groups were followed up by measurements of serum levels of human chorionic gonadotrophin (HCG), oestradiol and progesterone every three days until day 35, when a first ultrasound examination was carried out to confirm fetal vitality. Subsequently, pregnancies were monitored sonographically at regular intervals. In cases of miscarriage, dilatation and curettage was performed and histology analysed. A total of 120 pregnant patients entered the study: 55 of them received hormone treatment and 65 patients were controls. Within the treatment group 48 (89%) clinically ongoing pregnancies were observed, five (9%) miscarriages occurred after the seventh week of gestation and one preclinical pregnancy was noted. In the control group, 38 (59%) ongoing pregnancies were observed, nine (14%) miscarriages occurred and 17 (27%) preclinical pregnancies were recorded. Two ectopic pregnancies, one in each group, were excluded from evaluation. A significantly higher percentage of pregnancies were intact at 7 weeks of gestation after treatment with PC/EV (p less than or equal to 0.01).

17 alpha-Hydroxyprogesterone Caproate↗

PubMed1995

Primary care management of acute herpes zoster: systematic review of evidence from randomized controlled trials.

Although a number of randomized controlled trials of treatment for herpes zoster have been performed, there is no consensus on how it should be managed in general practice. A systematic review of existing trials, including meta-analysis, was performed to determine the efficacy of available therapies in reducing the incidence of postherpetic neuralgia. The treatments studied included antiviral agents, corticosteroids and other drugs which had been studied in randomized trials. Trials were included if the subjects were immunocompetent adults and the intervention was feasible in general practice. The main outcome measure was prevalence of pain at one, three and six months after onset of the acute herpetic rash. Data for each time point were not available for all trials. The quality of studies was also assessed. Pooled analyses of trials with acyclovir failed to detect a significant reduction of pain in the treatment group at one or six months, but found a 35% reduction at three months. Confidence limits were wide, and a modest benefit of treatment cannot be ruled out at one and six months. Pooled analyses were not possible for other treatments, either because too few trials had been performed, or because completed trials demonstrated significant heterogeneity. Many clinical trials in this area have been too small to give reliable results. Variations in the definition and reporting of postherpetic neuralgia create difficulties in combining data from different studies. Firm recommendations for clinical practice are not possible because existing evidence neither confirms nor refutes the hypothesis that treatment during the acute phase of herpes zoster reduces pain later.

Acute Disease↗

PubMedDate not supplied

Methodological issues of randomized controlled trials for the evaluation of reproductive health interventions.

Randomized controlled trials proved the most valid basis for comparing alternative treatment modalities. Unfortunately, the quality of many such trials has not been as high as our patients deserve. We offer here methodological and practical insights to key issues related to the design, implementation, and analysis of randomized controlled trials in obstetrics and gynecology, based on our experience in exploring research hypotheses in this field. Specifically, we present randomization as a method for the prevention of confounding; we discuss the process of randomization and the bias that can be introduced to randomized controlled trials by some popular methods of randomization. The strategies for presenting baseline comparisons and evaluating the impact of a treatment or intervention are also reviewed. We hope to contribute to a more rigorous selection of treatments for our clinical and public health armamentarium.

Bias↗

PubMedDate not supplied

Efficacy of intravaginal misoprostol in second-trimester pregnancy termination: a randomized controlled trial.

A prospective randomized, double-blind, controlled clinical trial to compare the clinical efficacy and side effects of intravaginal misoprostol with the traditional prostaglandin, gemeprost, in second-trimester pregnancy interruption was conducted. A sample size of 100 women was calculated to demonstrate that misoprostol was as effective as gemeprost in achieving delivery within 24 hours (alpha = 0.1, 80% power). Women were recruited with fetal death in utero, severe fetal anomaly, or psychosocial pregnancy termination between 14 and 28 weeks gestation and randomized to receive either 1 mg gemeprost 3 hourly for 5 doses, or 200 mcg misoprostol 6 hourly for 4 doses, intravaginally. The therapeutic regimens were repeated if undelivered by 24 hours. Those undelivered after 48 hours received an extra-amniotic PGF2 alpha infusion. The median gestation at recruitment was identical: gemeprost 19 weeks (IQ 17-22 weeks) vs. misoprostol 19 weeks (IQ 17-21 weeks), P = 0.887. Delivery within 24 hours occurred in 75.1% of women receiving gemeprost and 74.9% receiving misoprostol (P = 1.0). The median time from prostaglandin commencement to delivery was similar: gemeprost 13.7 hours (IQ 9.0-23.5 hours) vs. misoprostol 16.9 hours (IQ 10.3-23.5 hours), P = 0.769. A significant reduction in the incidence of vomiting in women randomized to misoprostol occurred (34% vs. 13.2%, P = 0.017). There was no significant difference in the incidence of maternal fever > 37.5 degrees C, nausea, diarrhea, or placental retention. A 200-fold pharmaceutical cost advantage was observed with the use of misoprostol compared with gemeprost. Intravaginal misoprostol performs as effectively as gemeprost in achieving delivery in the second trimester without increase in adverse effects and displaying a significant cost advantage.

Abortifacient Agents, Nonsteroidal↗

PubMed1992

Economic analysis in randomized control trials.

In medical technology assessment, randomized control trials (RCTs) play an important role in determining the relative efficacy of compared treatments. As scarce resources necessitate choosing among options for care, comparing costs of alternative tests, treatments, or programs also becomes important. This study assessed the prevalence and completeness of economic analyses in RCTs published from January 1966 through June 1988. It was found that only 121 of over 50,000 published randomized trials (0.2%) included economic analyses. For a random sample of 51 of these 121 studies, results revealed a mean quality of research score of 0.32 (SD of measurement = 0.14) and a mean economic analysis completeness score of 0.52 (SD = 0.13) on scales of 0 to 1. It was also found that higher economic completeness scores were positively correlated with later dates of publication (r = 0.28, P = 0.046) and with the presence of a statement of study perspective (r = 0.38, P = 0.006). A near-zero correlation between the economic completeness and the quality of research scores was revealed. Also noted were several deficiencies among the economic analyses, including improper allocation of overhead costs, absence of sensitivity analyses, and the fact that only 28% of the 51 studies included some form of aggregation of treatment costs and consequences. Progress in health care depends on accurate assessments of both relative efficacy and costs. The quality of both needs improvement.

Cost-Benefit Analysis↗

PubMed1988

Prospective controlled randomized trial of prophylactic antiarrhythmic therapy in postmyocardial infarction patients with asymptomatic ventricular arrhythmias--study design and initial results.

In order to assess the effect of prophylactic antiarrhythmic therapy in asymptomatic patients with persistent complex ventricular ectopic activity after myocardial infarction, a prospective controlled trial was started in 1981 and is still ongoing. Until August 1986, 965 consecutive patients less than or equal to 70 hospitalized for acute myocardial infarction were screened without antiarrhythmic drugs by 24-h ECG before discharge from the hospital. In this group, 238 patients (28%) had ventricular arrhythmias Lown class III-IVb during at least 2 of 24 hours; they were randomly assigned to three treatment groups: (1) individualized antiarrhythmic therapy based on efficacy in multiple 24-h ECGs and drug level determinations (starting with mexiletine or quinidine; n = 79), (2) treatment with low-dose amiodarone (200-400 mg/day after a loading phase; n = 73), and (3) no antiarrhythmic therapy (n = 86). The three groups were comparable regarding age, gender, previous infarction, Q-wave infarction, ejection fraction, as well as incidence and severity of ventricular ectopic activity. Follow-up, including 24-h ECGs, was performed after 3, 6, and 12 months. Based on the results of this study which will be completed by the end of June 1988, it should be possible to estimate the benefit--or harm--of antiarrhythmic drug therapy as well as its cost in postmyocardial infarction patients with asymptomatic ventricular ectopic activity and to decide whether such treatment may improve survival.

Aged↗

PubMed1995

A model of regular geriatric follow-up by home visits to selected patients discharged from a geriatric ward: a randomized controlled trial.

The aim of this randomized controlled trial was to describe and evaluate a model of regular follow-up by home visits to selected elderly patients discharged from a geriatric ward. Ninety-seven patients were randomized to receive regular follow-up visits by a geriatric team at 1, 3, 8 and 16 weeks after discharge, and 96 patients to receive standard care. Based on the geriatric evaluation, medical and social adjustment was carried out, if indicated. Six months after discharge, significantly more patients in the intervention group were allocated to home help (p < 0.05), but only 42 (44%) were readmitted to a hospital, vs 62 (64%) in the control group (p < 0.005). Differences between the groups in mortality and nursing-home placement were not statistically significant. Regular follow-up home visits by a geriatric team after in-patient geriatric evaluation and management reduce the risk of hospital readmissions among highly selected frail geriatric patients.

Aged↗

PubMed1984

Antibiotic prophylaxis in neurosurgery. A randomized controlled trial.

A randomized trial was performed to support the contention that prophylactic antibiotics can reduce the incidence of postoperative neurosurgical wound infections. The regime outlined by Malis was followed. Vancomycin and gentamicin were administered systemically just prior to surgery and streptomycin was added to the irrigating solution. Patients were randomly assigned to two groups: control and treated. The infection rate in the control group was 3.5% and in the treated group 0.5%.

Adult↗

PubMed1991

A comparison of sucralfate with placebo in the treatment of esophageal ulcers following therapeutic endoscopic sclerotherapy of esophageal varices--a prospective controlled randomized trial.

In 1984 Roark published the first report of a sucralfate treatment of esophageal ulcers after sclerotherapy. Because this was an uncontrolled trial we planned a prospective double-blind placebo-controlled study with 60 patients. After therapeutic paravariceal injection-sclerotherapy of esophageal varices, patients were randomly treated with sucralfate suspension or placebo. Time of treatment was limited to a maximum of 3 weeks and the dosage of sucralfate was 1 g q.i.d. (Ulcogant-Suspension). Healing was assessed by endoscopy at weekly intervals. Fifty-three patients (25 sucralfate, 28 placebo) were evaluable according to the protocol. No patient left the study because of side effects. At the start of the trial, the patients in the sucralfate group showed a larger ulcer area than the placebo group. There was a tendency to faster healing in the sucralfate group, especially in patients with deeper ulcerations. However, there was no significant difference in global healing between both treatment groups after 3 weeks. Sucralfate suspension may be of value in accelerating the healing process in esophageal ulcers after sclerotherapy, especially in patients with deep ulcers. These results should be confirmed in further trials, in which patients should be stratified with respect to their ulcer volume and severity of liver disease.

Aged↗

PubMed1994

Review of 39 years of randomized controlled trials in the British Journal of General Practice.

BACKGROUND: Randomized controlled trials are being used increasingly to evaluate the effectiveness of health care interventions, including those in primary care. AIM: A study was undertaken to document the topic areas addressed by randomized controlled trials conducted in primary care and the methodological characteristics of these, based on a historical review of all trials published in the British Journal of General Practice (formerly the Research Newsletter and Journal of the Royal College of General Practitioners) between 1953 and 1991 inclusive. METHOD: Trials were identified by systematically hand searching all back issues. RESULTS: A total of 90 randomized controlled trials were identified, 78% of which were undertaken in general practice. The trials covered a wide range of topics; 62% examined pharmacological interventions, 21% non-pharmacological interventions, and 16% an intervention related to provision of an aspect of health service. Among the randomized controlled trials published there was a significant trend towards more reports on non-pharmacological trials in recent years (P < 0.001). The quality of trials, judged by the extent to which bias was controlled, varied considerably. Trials of pharmacological interventions generally controlled for selection bias at entry and at assessment of outcome more effectively than trials of non-pharmacological interventions. CONCLUSION: Some imaginative solutions to the logistic difficulties of conducting randomized trials in general practice were noted. These may serve as an incentive to those undertaking such studies in the future.

Community Health Services↗

PubMed1990

Captopril improves hemodynamic response to static exercise in patients with congestive heart failure: a double-blind, placebo-controlled, randomized trial.

Systemic and peripheral hemodynamic response to isometric exercise by handgrip test at 30% maximal voluntary contraction (MVC) for 3 minutes was assessed in 16 patients with congestive heart failure (CHF) after short-term treatment with either captopril or placebo given according to a double-blind, randomized, cross-over sequence. During placebo, isometric exercise increased blood pressure (BP) and total peripheral vascular resistance (TPVR) and decreased cardiac index (CI). Captopril reduced the pressor response to exercise (mean +/- SD) (% systolic: from 14.7 +/- 6 to 11.7 +/- 3; p less than .05/% diastolic: from 12.4 +/- 4 to 8 +/- 3; p less than .005) and increased CI (from 2.3 +/- .6 to 2.6 +/- .9 liters/min/m2; p less than .01) whereas TPVR remained virtually unchanged (from 1479 +/- 597 to 1594 +/- 692 U; NS). The changes in mean BP after exercise were inversely related to the early increase in forearm blood flow (FBF) in exercising forearm during both placebo (r = .67) and captopril (r = .71). The extent of reduction in mean BP response after captopril was inversely related to the extra increase in exercising FBF determined by the drug when compared to placebo (r = .73). We conclude that captopril is able to improve the hemodynamic response to static exercise in patients with CHF, probably by increasing the blood supply to exercising muscles during contraction, thus blunting the extent of reflex pressor response.

Blood Pressure↗

PubMed1998

The reduction of chronic nonspecific low back pain through the control of early morning lumbar flexion. A randomized controlled trial.

STUDY DESIGN: Eighteen-month, randomized controlled trial with partial crossover. OBJECTIVES: To test the hypothesis that the control of lumbar flexion in the early morning will significantly reduce chronic, nonspecific low back pain. SUMMARY OF BACKGROUND DATA: Previous studies have indicated an increased risk of low back pain with bending forward in the early morning, primarily because of increased fluid content in the intervertebral discs at that time. METHODS: After 6 months of recording baseline data, 85 subjects with persistent or recurring low back pain were randomly assigned to treatment and control groups. The treatment group received instruction in the control of early morning lumbar flexion. The control group received a sham treatment of six exercises shown to be ineffective in reducing low back pain. Six months later, the control group received the experimental treatment, Diaries were used to record daily levels of pain intensity, disability, impairment, and medication usage. RESULTS: Significant reductions in pain intensity (P < 0.01) were recorded for the treatment group, but not for the control group (point estimate, 33%; 95% confidence interval, 11-55%). After receiving the experimental treatment, the control group responded with similar reductions (P < 0.05). Significant reductions also were observed in total days in pain, disability, impairment, and medication usage. CONCLUSIONS: Controlling lumbar flexion in the early morning is a form of self-care with potential for reducing pain and costs associated with chronic, nonspecific low back pain.

Activities of Daily Living↗

PubMed1988

Cyclosporin-induced remission of IDDM after early intervention. Association of 1 yr of cyclosporin treatment with enhanced insulin secretion. The Canadian-European Randomized Control Trial Group.

A randomized double-blind placebo-controlled trial was undertaken to determine whether cyclosporin enhances remission of insulin-dependent diabetes mellitus (IDDM) through the 1st yr after diagnosis. Dosage with insulin was minimized with target control of blood glucose levels less than or equal to 7.8 mM (140 mg/dl) before meals. Metabolic control was evaluated by serial determinations of glycosylated hemoglobin levels, and endogenous secretion of insulin was evaluated by determination of the levels of glucagon-stimulated insulin-connecting peptide (CP) in the plasma at 3-mo intervals. A compound definition of remission required a glucagon-stimulated CP level in plasma greater than or equal to 0.6 nM or a non-insulin-receiving state (NIR) in which target control of glycemia was maintained without administration of insulin. A clinical definition of remission required only the NIR state as defined. One hundred eighty-eight patients aged 10-35 yr entered the study within 6 wk of initiation of insulin therapy and within 14 wk of onset of symptoms and were studied for 1 yr. There were no significant differences in metabolic control between the two treatment groups during the study. The anticipated adverse effects of cyclosporin were not more frequent or severe than in other experience with the drug, but histological changes attributable to cyclosporin were present in some kidney biopsies obtained from selected patients after 1 yr. At 1 yr, by the compound definition, 33% of the cyclosporin-group and 21% of the placebo-group patients were in remission, when the corresponding rates for NIR remissions were 24 and 10%.(ABSTRACT TRUNCATED AT 250 WORDS)

Adolescent↗

PubMed1989

Prospective, controlled, randomized trial of naloxone infusion in early hyperdynamic septic shock.

To determine whether naloxone infusion is efficacious in severe hyperdynamic septic shock, we conducted a prospective study of 22 patients randomly assigned to a naloxone or placebo group. Patients were treated 12 +/- 2 h (SEM) after the onset of shock, with a mean arterial pressure (MAP) of 63 +/- 3 mm Hg. All patients had clinical evidence of an infectious process and required dopamine 20 +/- 2 micrograms/kg.min. Five (46%) of 11 patients in the naloxone group and one (9%) of the other 11 patients in the placebo group responded clinically. The MAP among the five responders increased from 62 +/- 5 to 89 +/- 4 mm Hg within 20 min of naloxone treatment (p less than .01). This favorable hemodynamic response was sustained throughout the patients' clinical course. In contrast, the MAP did not change significantly in the nonresponders who received naloxone, nor did it change in the placebo group. More patients in the naloxone group than in the placebo group received steroids concurrently. Survival rate was 100% in those who responded to naloxone clinically. However, overall survival rate in each group was essentially the same. No adverse effects were observed, except for mild agitation in some of the patients receiving naloxone. We conclude that naloxone infusion is clinically efficacious in improving the hemodynamic profile of a subgroup of patients with severe early hyperdynamic septic shock, but does not appear to improve the overall survival rate.

Aged↗