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Results for “Randomized controlled trials”

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At least 757 records · Page 42Linked to original sources
PubMed2007

Cognitive behavior therapy and paroxetine in the treatment of hypochondriasis: a randomized controlled trial.

OBJECTIVE: This study, to the authors' knowledge, is the first randomized controlled trial comparing the efficacy of cognitive behavior therapy (CBT), paroxetine, and a placebo (administered in a double blind fashion) in the treatment of hypochondriasis. METHOD: The authors randomly assigned 112 subjects with hypochondriasis according to DSM-IV criteria to 16 weeks of outpatient treatment with CBT, paroxetine, or a placebo. The main outcome measure was the Whiteley Index. The authors made pretest and posttest assessments and analyzed all outcome measures using a General Linear Model 3x2 repeated measures analysis of variance with Helmert contrasts. The authors considered subjects who scored at least one standard deviation below the mean pretest score on the Whiteley Index as responders. All analyses were conducted on intent-to-treat and completer bases. RESULTS: On the Whiteley Index, Helmert contrasts on the intent-to-treat and completer cohorts revealed that pooled CBT and paroxetine were significantly superior to placebo, but did not differ significantly from each other. The responder analysis on the intent-to-treat cohort and completer cohort, respectively, revealed the following percentages of responders per group: CBT group, 45% and 54%; paroxetine group, 30% and 38%; and placebo group, 14% and 12%. In the intent-to-treat analysis, only CBT differed significantly from the placebo. In the completer analysis, both paroxetine and CBT differed significantly from the placebo. CONCLUSIONS: CBT or paroxetine are effective short-term treatment options for subjects with hypochondriasis.

Adult↗
PubMed1993

A randomized controlled trial of solcoseryl and duoderm in chronic sickle-cell ulcers.

A randomized controlled trial of Solcoseryl, DuoDerm and conventional conservative therapy with Eusol has been performed in 32 patients with homozygous sickle-cell (SS) disease. After 12 weeks' baseline observation, patients were randomized to one of three therapies and monitored for a further 12 weeks. Of 44 ulcerated legs, 20 received control treatment, 12 Solcoseryl and 12 DuoDerm. DuoDerm was generally unacceptable, and two-thirds of the patients defaulted from this treatment. Solcoseryl increased ulcer healing compared to the controls but the difference was not significant. Solcoseryl was well tolerated and may have a role in the treatment of chronic leg ulcers of sickle-cell disease.

Actihaemyl↗
PubMed2001

Incomplete miscarriage: a randomized controlled trial comparing oral with vaginal misoprostol for medical evacuation.

BACKGROUND: A prospective randomized controlled trial was conducted to compare the efficacy and side-effects of vaginal versus oral misoprostol in the medical management of incomplete miscarriage. METHODS: Two hundred and one patients who miscarried consented to randomization using computer-generated randomization model prior to treatment. A total of 800 microg of misoprostol was given either vaginally or orally to the randomized subjects. A second dose was repeated 4 h later if the product of conception had not been passed. RESULTS: The incidence of complete uterine evacuation following vaginal and oral misoprostol was similar [(58/95) 61.1% versus (67/103) 64.4%]. There was a significantly decreased incidence of diarrhoea [(12/95) 13.6% versus (62/103) 65.3%, P < 0.01] with the use of vaginal misoprostol. CONCLUSIONS: Vaginal misoprostol was as effective as oral misoprostol in medical uterine evacuation in patients with incomplete miscarriage. There was also a reduction in the incidence of diarrhoea with the use of vaginal misoprostol.

Abortion, Incomplete↗
PubMed2003

Persistence of Salmonellae in blood and bone marrow: randomized controlled trial comparing ciprofloxacin and chloramphenicol treatments against enteric fever.

We performed a randomized controlled trial involving 55 adult patients with enteric fever to compare ciprofloxacin and chloramphenicol. Blood and bone marrow cultures and cytokine profiles during therapy were done to compare the clinical and bacteriological efficacies of these drugs. All patients were randomly assigned to receive chloramphenicol (500 mg four times a day orally) for 14 days or ciprofloxacin (500 mg twice a day orally) for 7 days. In each treatment group, patients were subsequently randomized to have blood and bone marrow cultured after either 3 or 5 days of treatment. Twenty-seven patients received chloramphenicol, and 28 received ciprofloxacin. The two groups were similar in terms of baseline characteristics. No significant differences in clinical cure and time to defervescence were found. All strains isolated were susceptible to both antibiotics. Although ciprofloxacin was more effective in the elimination of Salmonella enterica serovars Typhi and Paratyphi A from bone marrow than chloramphenicol, there was still an impressive persistence of Salmonella in the bone marrow culture (67%). In the ciprofloxacin-treated patients the suppressed cytokine production capacity showed a trend to normalize earlier than in patients treated with chloramphenicol.

Adolescent↗
PubMed2004

Once a pregnancy, always a cesarean? Rationale and feasibility of a randomized controlled trial.

Although vaginal delivery has long been assumed to be the preferred route of delivery in women who have not had a prior cesarean delivery, some have recently advocated that women be offered the option of elective, primary cesarean delivery in all pregnancies. Available outcome data, however, do not permit ready comparison of these alternate plans for delivery. Important maternal outcomes include short-term complications such as death, bleeding, infection, and damage to pelvic organs as well as long-term effects on future pregnancies, fecal and urinary incontinence, and pelvic organ prolapse. Important neonatal outcomes include asphyxic and traumatic birth injury, infection, respiratory complications, and stillbirth. To weigh the relative merits of elective primary cesarean delivery and a trial of labor, a randomized controlled trial is needed. Such a trial would be both ethical and feasible.

Cesarean Section↗
PubMed2004

GnRH antagonist versus long GnRH agonist protocol in poor responders undergoing IVF: a randomized controlled trial.

BACKGROUND: This is the first published report of a prospective, randomized, controlled trial comparing a fixed, multi-dose GnRH antagonist protocol with a long GnRH agonist protocol in poor responders undergoing IVF. METHODS: Sixty-six poor responders were randomized into two groups: the study group received 0.25 mg of cetrorelix daily starting on day 6 of stimulation; the control group received 600 microg of buserelin acetate daily starting in the mid-luteal phase of the preceding cycle. Both groups were given a fixed dose of recombinant FSH (300 IU daily) for stimulation. RESULTS: There were no significant differences in the cycle cancellation rates, duration of stimulation, consumption of gonadotrophins, and mean numbers of mature follicles, oocytes and embryos obtained. The implantation rates were similar, but the number of embryos transferred was significantly higher for the antagonist group (2.32 +/- 0.58 versus 1.50 +/- 0.83; P = 0.01). The pregnancy rates were also higher in the antagonist group, but the difference was not statistically significant. CONCLUSION: A fixed multi-dose GnRH antagonist protocol is feasible for patients who are poor responders on a long agonist protocol; however, our study failed to demonstrate an overall improvement in ovarian responsiveness. Clinical outcomes may be improved by developing more flexible antagonist regimens, an approach that requires further evaluation.

Adult↗
PubMed1990

A European multicenter randomized controlled trial of single dose surfactant therapy for idiopathic respiratory distress syndrome.

We performed a multicenter prospective randomized controlled trial to determine the efficacy and safety of the surfactant preparation, Survanta (Abbott Laboratories, Chicago, USA), for 750-1750 g infants with idiopathic respiratory distress syndrome, (IRDS) receiving assisted ventilation with 40% or more oxygen. One hundred and six eligible infants from the eight participating centers were randomly assigned between March 1986 and June 1987 to receive either surfactant (100 mg phospholipid/kg, 4 ml/kg) or air (4 ml/kg) administered into the trachea within 8 h of birth (median time of treatment 6.2 h, range 3.2-9.1 h). The study was stopped before enrollment was completed at the request of the United States Food and Drug Administration when significant differences were observed in incidence of periventricular-intraventricular hemorrhage (PIH), between the surfactant treated and control infants. Surfactant treated infants had larger average increases in the arterial-alveolar oxygen ratio, (a/A ratio) (P less than 0.0001), and larger average decreases in FiO2 (P less than 0.0001) and mean airway pressure, (MAP) (P less than 0.017) than controls over the 48 h following treatment. The magnitude of the differences between the surfactant and control groups were 0.19 (SE = 0.03) for a/A ratio, -0.28 (SE = 0.04) for FiO2 and -1.7 cm H2O (SE = 0.70) for MAP. The clinical status on days 7 and 28 after treatment was classified using four predefined ordered categories: (1) no respiratory support; (2) supplemental O2 with or without continuous positive airway pressure (CPAP); (3) intermittent mandatory ventilation; and (4) death. There were no statistically significant differences in the status categories on days 7 or 28 between surfactant and control infants.(ABSTRACT TRUNCATED AT 250 WORDS)

Administration, Inhalation↗
PubMed2001

Effects of alcohol reduction on blood pressure: a meta-analysis of randomized controlled trials.

Alcohol drinking has been associated with increased blood pressure in epidemiological studies. We conducted a meta-analysis of randomized controlled trials to assess the effects of alcohol reduction on blood pressure. We included 15 randomized control trials (total of 2234 participants) published before June 1999 in which alcohol reduction was the only intervention difference between active and control treatment groups. Using a standard protocol, information on sample size, participant characteristics, study design, intervention methods, duration, and treatment results was abstracted independently by 3 investigators. By means of a fixed-effects model, findings from individual trials were pooled after results for each trial were weighted by the inverse of its variance. Overall, alcohol reduction was associated with a significant reduction in mean (95% confidence interval) systolic and diastolic blood pressures of -3.31 mm Hg (-2.52 to -4.10 mm Hg) and -2.04 mm Hg (-1.49 to -2.58 mm Hg), respectively. A dose-response relationship was observed between mean percentage of alcohol reduction and mean blood pressure reduction. Effects of intervention were enhanced in those with higher baseline blood pressure. Our study suggests that alcohol reduction should be recommended as an important component of lifestyle modification for the prevention and treatment of hypertension among heavy drinkers.

Adult↗
PubMed1998

Randomized controlled trial comparing same-day discharge with hospital stay following haemorrhoidectomy.

BACKGROUND: A randomized controlled trial was conducted to compare traditional hospital stay haemorrhoidectomy (STAY) with same-day discharge haemorrhoidectomy (DAY) with regard to costs, clinical outcome and patient satisfaction. METHODS: A total of 54 consecutive patients were randomized to either STAY or DAY groups. A standardized excision of three piles was performed and the wounds were left open. The DAY patients went home on the same day but the STAY patients remained in hospital until their bowels had opened. A linear analogue pain score and patient satisfaction questionnaire were administered. During a mean follow-up of 60.5 (standard error of mean = 1.2) weeks, the complications and the total medical costs were recorded RESULTS: There were no differences in the age and sex distributions in both groups (STAY: 11 men, 16 women; mean age 40.6 (+/- 1.8) years; DAY: 10 men, 17 women; mean age 40.6 (+/- 1.9) years). Despite accounting for any readmissions, the DAY patients accumulated shorter total hospitalization stays (P < 0.001) and incurred less total medical costs (P = 0.04). The pain scores, analgesia requirements, postoperative complications, patient satisfaction and time taken off work were not different between the two groups. However, more patients in both groups preferred to stay after surgery if they should need another haemorrhoidectomy. CONCLUSIONS: Haemorrhoidectomy (with excision of three piles) can be safely performed as a day procedure, with reduced hospitalization and medical costs.

Adult↗
PubMed2006

The rate of bleeding complications after pharmacologic deep venous thrombosis prophylaxis: a systematic review of 33 randomized controlled trials.

HYPOTHESIS: Major bleeding complications from pharmacologic deep venous thrombosis (DVT) prophylaxis are infrequent. DESIGN: Systematic review of the MEDLINE database from 1965 to August 2005, using the terms DVT, prophylaxis, general surgery, and heparin. SETTING AND PATIENTS: Randomized controlled trials evaluating pharmacologic DVT prophylaxis in patients undergoing general surgery. MAIN OUTCOME MEASURES: Eight complication categories: injection site bruising, wound hematoma, drain site bleeding, hematuria, gastrointestinal tract bleeding, retroperitoneal bleeding, discontinuation of prophylaxis, and subsequent operation. RESULTS: Fifty-two randomized controlled trials studied DVT prophylaxis; 33 randomized controlled trials with 33 813 patients undergoing general surgery evaluated pharmacologic prophylaxis and quantified bleeding complications. Of the minor complications, injection site bruising (6.9%), wound hematoma (5.7%), drain site bleeding (2.0%), and hematuria (1.6%) were most common. Major bleeding complications, such as gastrointestinal tract (0.2%) or retroperitoneal (<0.1%) bleeding, were infrequent. Discontinuation of prophylaxis occurred in 2.0% of patients and subsequent operation in less than 1% of patients. When analyzed by high- vs low-dose unfractionated heparin, the lower dose had a smaller rate of discontinuation of prophylaxis (P = .02) and subsequent operation (P = .06). CONCLUSIONS: Knowledge of bleeding complication rates is important for surgeons because DVT prophylaxis may soon be implemented by Medicare as a quality measure. This level 1 evidence report shows that bleeding complications requiring a change in care occur less than 3% of the time and seem reduced with lower-dose prophylaxis. Given these findings, most patients undergoing general surgery could receive pharmacologic prophylaxis safely.

Anticoagulants↗
PubMedDate not supplied

Difficulties of recruitment for a randomized controlled trial involving influenza vaccination in healthy older people.

BACKGROUND: In a randomized controlled trial to determine the cost benefits of influenza vaccination in fit healthy individuals aged 65-74 years, recruiting individuals to the study was more difficult than anticipated. OBJECTIVES: To investigate reasons for poor recruitment. MATERIALS AND METHODS: 6,058 people were initially identified as eligible for the study but only 729 (12%) were subsequently randomized. Individuals (n = 2,583) who returned cards indicating that they did not wish to participate were sent a postal questionnaire asking for reasons why they felt unable to consent for the study. RESULTS: 1,173/2,583 (45.4%) questionnaires were returned. A total of 2,621 reasons were given for nonparticipation, i.e. a mean of 2.2 reasons per questionnaire returned. Reasons given for noninvolvement were: reluctance to participate in a research project (53%); concerned about side effects (34%); self-perceived view of not requiring influenza vaccination (31.7%); preference for own doctor to give the vaccine (29.1%); objection to name "Geriatric Medicine" on the letter of invitation (25.2%); already been vaccinated (17.3%); illness requiring vaccination out of the study (13.8%); previous bad reaction to the vaccine (6.4%); unable to attend on day of vaccination (4.3%); unable to get to general practice surgery (4%); already involved in a clinical trial (2.5%); fear of needles/dislike of injections (1.6%); doubts about vaccine efficacy (0.3%); egg allergy (0.2%). CONCLUSION: Inaccurate beliefs about influenza vaccination persist across a wide section of the community. Efforts should be made by all health professionals to correct these false beliefs and ensure that those at risk can be easily recognized and targeted for vaccination.

Aged↗
PubMed2006

A 5-year follow-up evaluation of the health and economic consequences of an early cognitive behavioral intervention for back pain: a randomized, controlled trial.

STUDY DESIGN: A 5-year follow-up of a randomized, controlled trial. OBJECTIVE: To evaluate the long-term health and economic consequences of a cognitive behavioral intervention. SUMMARY OF BACKGROUND DATA: Linton and Andersson (Spine 2000;25:2825-31) provide 1 of only a few studies on the preventive effects of a cognitive behavioral intervention. The present study is a 5-year follow-up. METHODS: In the original study, 213 participants were randomized to the cognitive-behavioral group intervention or to usual care plus information on self-care (information comparison group). Of participants, 97% completed a follow-up questionnaire 5 years after the intervention, and supplemental records were obtained from the National Insurance Authority. RESULTS: The cognitive behavioral group had significantly less pain, was more active, enjoyed better quality of life, and had better general health relative to the information comparison group. There was no difference on health care use. The risk of long-term sick leave was 3 times higher in the information comparison group. The cognitive behavioral group had significantly less lost productivity costs and a lower total cost/y/person (16,514 Swedish kronor) compared to the information comparison group (45,990 Swedish kronor). CONCLUSIONS: A cognitive-behavioral group intervention produces long-term health and economic benefits. Usual medical care might be improved considerably by implementing these psychologic methods.

Back Pain↗
PubMed2005

Randomized controlled trials of individual-level, population-level, and multilevel interventions for preventing sexually transmitted infections: what has worked?

BACKGROUND: Previous reviews of interventions to prevent sexually transmitted infections (STIs) focused mostly on human immunodeficiency virus (HIV) infection. We reviewed trials of interventions to prevent sexual transmission of any STI, employing a multilevel perspective. METHODS: We searched MEDLINE, the Cochrane Central Register of Controlled Trials, and recent unpublished presentations through 2003, to identify randomized controlled trials of preventive STI interventions having systematic, objective measurement of STI outcomes. We classified trials according to intervention target and level of randomization (individual, group, or community); impact target (acquisition, transmission, or complications of STI); and primary intervention modality. RESULTS: Of 83 trials identified, 41 met inclusion criteria, including trials of 28 individual-level, 9 group-level, and 4 community-level interventions. Among individual- and group-level interventions, 32 targeted acquisition, 4 targeted transmission, and 1 targeted complications of STI. The 4 intervention modalities most often used included behavior change (12 studies), vaccination (7 studies), use of topical microbicides (10 studies), and prophylactic, curative, or suppressive therapy (10 studies). Community-level interventions had multiple impact targets, and 2 interventions used multiple modalities. Only 1 intervention showed efficacy against sexual transmission of HIV, but 22 (53.7%) showed effectiveness against other STIs. CONCLUSION: Although many interventions have been found to be effective against STIs, few have been replicated, widely implemented, or carefully evaluated for effectiveness in other settings.

Female↗
PubMed2004

[Evidence-based surgical therapy: the significance of randomized controlled trials].

Evidence-based medicine supplies the information to solve clinical questions but there are specific problems of randomized controlled trials in surgery. First, placebo-controlled trials are need to determine the placebo effects, but patients sometimes refuse the placebo surgery. Furthermore, it remains difficult to decide on standard surgical procedures because the participating surgeons vary in skill and experience. However, randomized controlled trials are essential for the further development of a high-quality surgical standard.

Evidence-Based Medicine↗
PubMed1995

Effects of ACE inhibitors on mortality when started in the early phase of myocardial infarction: evidence from the larger randomized controlled trials.

This review summarizes the evidence from five of the larger randomized controlled trials evaluating the effects of angiotensin converting enzyme inhibitors started in the early phase of myocardial infarction on subsequent mortality and major morbidity. Altogether, information on about 98,000 patients is available from these trials. In four studies, trial treatment was started within 24 h, and in one study within 36 h, of the onset of symptoms of acute myocardial infarction, and mortality was assessed after a few weeks or months of treatment. When taken together, these trials show that angiotensin converting enzyme inhibitors produce a significant 7% relative risk reduction in mortality (P < 0.006), which corresponds to an absolute difference of about five fewer deaths per 1,000 patients treated. The benefits may be greater in higher-risk patients (e.g. those with previous myocardial infarction, heart failure or large infarcts). These results demonstrate that for a wide range of patients without clear contraindications, angiotensin converting enzyme inhibitors started early in acute myocardial infarction prevent further deaths in the first few weeks when added to standard therapy (aspirin, thrombolytic therapy and beta-blockers). The early benefits seen with ACE inhibitors seems to persist for at least the first year. The clinical implications of these results are discussed.

Angiotensin-Converting Enzyme Inhibitors↗
PubMed2002

Reporting number needed to treat and absolute risk reduction in randomized controlled trials.

CONTEXT: Ongoing efforts to improve the quality of reporting for randomized controlled trials (RCTs) include the Consolidated Standards of Reporting Trials (CONSORT) statement. We examined the frequency of explicit reporting of the number needed to treat (NNT) and the absolute risk reduction (ARR) in RCTs. METHODS: Five frequently cited journals were investigated: Annals of Internal Medicine, BMJ, JAMA, The Lancet, and the New England Journal of Medicine. For each journal, 4 years were evaluated: 1989, 1992, 1995, and 1998. All issues of each journal for each year were reviewed manually. Eligible articles were those in which an RCT was conducted on the use of a medication showing a significant treatment effect. Elements abstracted from each eligible article were the condition investigated, event being treated or prevented, intervention, study results, and reporting methods (relative risk reduction, NNT, and ARR). RESULTS: Of 359 eligible articles, NNT was reported in 8 articles. Six of the 8 studies were from 1998. Absolute risk reduction was reported in 18 articles, 10 of which were from 1998. CONCLUSIONS: Despite CONSORT recommendations, few authors expressed their findings in terms of NNT or ARR. Consideration should be given to including these values in reports of RCTs.

Data Interpretation, Statistical↗
PubMed1994

An analysis of randomized controlled trials published in the US family medicine literature, 1987-1991.

BACKGROUND: Randomized controlled trials (RCTs) are frequently used to evaluate the effectiveness of health care interventions in family medicine. The value of the information obtained from RCTs depends largely on the quality of design and the way in which they are conducted and reported. Despite the increasing number of RCTs being conducted in family medicine, there is a scarcity of descriptive data on the methodological characteristics, including design features and quality of RCTs in this setting. METHODS: All 55 RCTs published in four peer-reviewed US family medicine journals between 1987 and 1991 were identified and their methodological characteristics reviewed. Three potential sources of bias were assessed in each of the trial reports: (1) control of selection bias at entry, (2) control of selection bias after entry, and (3) control of bias in assessing outcome(s). RESULTS: Fifty-five RCTs published between January 1987 and December 1991 were identified in the four journals. The absolute number of RCTs published over the 5 years increased steadily, and there was a 49% increase in the proportion of RCT articles. Measures used to control for selection bias before entry into the study were reported in 14 (25%) of the RCTs, the statistical power of the trial in 5 (9%), and whether the study had been reviewed by an institutional review board in 6 (11%). CONCLUSIONS: The RCTs analyzed offered some imaginative solutions to the logistic difficulties of conducting RCTs in general practice. Nevertheless, the methodology and reporting of RCTs in the future should be improved.

Bias↗