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Results for “randomised controlled trial”

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PubMed2004

Bad reporting does not mean bad methods for randomised trials: observational study of randomised controlled trials performed by the Radiation Therapy Oncology Group.

OBJECTIVE: To determine whether poor reporting of methods in randomised controlled trials reflects on poor methods. DESIGN: Observational study. SETTING: Reports of randomised controlled trials conducted by the Radiation Therapy Oncology Group since its establishment in 1968. PARTICIPANTS: The Radiation Therapy Oncology Group. Outcome measures Content of reports compared with the design features described in the protocols for all randomised controlled trials. RESULTS: The methodological quality of 56 randomised controlled trials was better than reported. Adequate allocation concealment was achieved in all trials but reported in only 42% of papers. An intention to treat analysis was done in 83% of trials but reported in only 69% of papers. The sample size calculation was performed in 76% of the studies, but reported in only 16% of papers. End points were clearly defined and alpha and beta errors were prespecified in 76% and 74% of the trials, respectively, but only reported in 10% of the papers. The one exception was the description of drop outs, where the frequency of reporting was similar to that contained in the original statistical files of the Radiation Therapy Oncology Group. CONCLUSIONS: The reporting of methodological aspects of randomised controlled trials does not necessarily reflect the conduct of the trial. Reviewing research protocols and contacting trialists for more information may improve quality assessment.

Clinical Trials, Phase III as Topic↗
PubMed2002

TREC-Rio trial: a randomised controlled trial for rapid tranquillisation for agitated patients in emergency psychiatric rooms [ISRCTN44153243].

BACKGROUND: Agitated or violent patients constitute 10% of all emergency psychiatric treatment. Management guidelines, the preferred treatment of clinicians and clinical practice all differ. Systematic reviews show that all relevant studies are small and none are likely to have adequate power to show true differences between treatments. Worldwide, current treatment is not based on evidence from randomised trials. In Brazil, the combination haloperidol-promethazine is frequently used, but no studies involving this mix exist. METHODS: TREC-Rio (Tranquilização Rápida-Ensaio Clínico [Translation: Rapid Tranquillisation-Clinical Trial]) will compare midazolam with haloperidol-promethazine mix for treatment of agitated patients in emergency psychiatric rooms of Rio de Janeiro, Brazil. TREC-Rio is a randomised, controlled, pragmatic and open study. Primary measure of outcome is tranquillisation at 20 minutes but effects on other measures of morbidity will also be assessed. TREC-Rio will involve the collaboration of as many health care professionals based in four psychiatric emergency rooms of Rio as possible. Because the design of this trial does not substantially complicate clinical management, and in several aspects simplifies it, the study can be large, and treatments used in everyday practice can be evaluated.

Brazil↗
PubMed2003

Comparison of carvedilol and metoprolol on clinical outcomes in patients with chronic heart failure in the Carvedilol Or Metoprolol European Trial (COMET): randomised controlled trial.

BACKGROUND: Beta blockers reduce mortality in patients who have chronic heart failure, systolic dysfunction, and are on background treatment with diuretics and angiotensin-converting enzyme inhibitors. We aimed to compare the effects of carvedilol and metoprolol on clinical outcome. METHODS: In a multicentre, double-blind, and randomised parallel group trial, we assigned 1511 patients with chronic heart failure to treatment with carvedilol (target dose 25 mg twice daily) and 1518 to metoprolol (metoprolol tartrate, target dose 50 mg twice daily). Patients were required to have chronic heart failure (NYHA II-IV), previous admission for a cardiovascular reason, an ejection fraction of less than 0.35, and to have been treated optimally with diuretics and angiotensin-converting enzyme inhibitors unless not tolerated. The primary endpoints were all-cause mortality and the composite endpoint of all-cause mortality or all-cause admission. Analysis was done by intention to treat. FINDINGS: The mean study duration was 58 months (SD 6). The mean ejection fraction was 0.26 (0.07) and the mean age 62 years (11). The all-cause mortality was 34% (512 of 1511) for carvedilol and 40% (600 of 1518) for metoprolol (hazard ratio 0.83 [95% CI 0.74-0.93], p=0.0017). The reduction of all-cause mortality was consistent across predefined subgroups. The composite endpoint of mortality or all-cause admission occurred in 1116 (74%) of 1511 on carvedilol and in 1160 (76%) of 1518 on metoprolol (0.94 [0.86-1.02], p=0.122). Incidence of side-effects and drug withdrawals did not differ by much between the two study groups. INTERPRETATION: Our results suggest that carvedilol extends survival compared with metoprolol.

Adrenergic beta-Antagonists↗
PubMed2001

Active management of the third stage at caesarean section: a randomised controlled trial of misoprostol versus syntocinon.

The objective of this trial was to investigate whether 500 microg oral misoprostol given immediately after delivery of the neonate at Caesarean section is as effective as a bolus intravenous injection of 10 iu Syntocinon in stimulating uterine contractions and thereby reducing blood loss. Forty women undergoing elective or emergency Caesarean section were included in a placebo-controlled randomised trial. Group 1 received oral misoprostol and a placebo intravenous bolus and Group 2 received intravenous Syntocinon and oral placebo tablets. The main outcome measures were estimated blood loss at Caesarean section, drop in serum haemoglobin, and the need for additional uterotonic agents. We found that there was no significant difference (p = 0.75) in estimated blood loss between the two groups. No differences were observed in the decrease in haemoglobin, requirement for additional oxytocics, the need for blood transfusion or the degree of shivering in each group (p > 0.05 in each case). We concluded that oral misoprostol could be used as an alternative oxytocic agent for the third stage at Caesarean section. However, there is an obvious need for a larger randomised controlled trial to be undertaken. Previous published studies have concentrated on vaginal births and further studies should be extended to Caesarean deliveries.

Administration, Oral↗
PubMed2002

Early administration of intravenous magnesium to high-risk patients with acute myocardial infarction in the Magnesium in Coronaries (MAGIC) Trial: a randomised controlled trial.

BACKGROUND: The benefits of supplemental administration of intravenous magnesium in patients with ST-elevation myocardial infarction (STEMI) are controversial. Despite promising results from work in animals and the ready availability of this simple, inexpensive treatment, conflicting results have been reported in clinical trials. Our aim was to compare short-term mortality in patients with STEMI who received either intravenous magnesium sulphate or placebo. METHODS: We did a randomised, double-blind trial in 6213 patients with acute STEMI who were assigned a 2 g intravenous bolus of magnesium sulphate administered over 15 min, followed by a 17 g infusion of magnesium sulphate over 24 h (n=3113), or matching placebo (n=3100). Our primary endpoint was 30-day all-cause mortality. At randomisation, patients were stratified by their eligibility for reperfusion therapy. The first stratum included patients who were aged 65 years or older and eligible for reperfusion therapy, and the second stratum included patients of any age who were not eligible for reperfusion therapy. Analysis was by intention-to-treat. FINDINGS: At 30 days, 475 (15.3%) patients in the magnesium group and 472 (15.2%) in the placebo group had died (odds ratio 1.0, 95% CI 0.9-1.2, p=0.96). No benefit or harm of magnesium was observed in eight prespecified subgroup analyses of patients and in 15 additional exploratory subgroup analyses. After adjustment for factors shown to effect mortality risk in a multivariate regression model, no benefit of magnesium was observed (1.0, 0.8-1.1, p=0.53). INTERPRETATION: Early administration of magnesium in high-risk patients with STEMI has no effect on 30-day mortality. In view of the totality of the available evidence, in current coronary care practice there is no indication for the routine administration of intravenous magnesium in patients with STEMI.

Aged↗
PubMed2003

Effect of short-term treatment with azithromycin on recurrent ischaemic events in patients with acute coronary syndrome in the Azithromycin in Acute Coronary Syndrome (AZACS) trial: a randomised controlled trial.

BACKGROUND: There is serological and epidemiological evidence of an association between Chlamydia pneumoniae infection and coronary artery disease. Results of previous smaller studies have indicated a reduction of recurrent ischaemic events in patients with acute coronary syndrome when given macrolide antibiotics. We aimed to assess whether short-term treatment with the macrolide antibiotic azithromycin reduces recurrent ischaemic events in patients admitted for unstable angina or myocardial infarction. METHODS: We assessed the effect of azithromycin in a multicentre, double-blind randomised trial in 1439 patients with unstable angina or acute myocardial infarction. Patients were randomly allocated to receive 500 mg azithromycin on the first day after randomisation, followed by 250 mg daily for 4 days or placebo. Patients were followed up for 6 months. The primary endpoints were death, recurrent myocardial infarction, or recurrent ischaemia necessitating revascularisation. Analysis was done by intention to treat. FINDINGS: Treatment with azithromycin did not result in reduction of either individual endpoints or any of the primary endpoints. Of the 716 patients in the azithromycin group, 23 (3%) died, 17 (2%) developed myocardial infarction, 65 (9%) had recurrent ischaemia needing revascularisation, and 100 (14%) had one or more of these endpoints. In the placebo group (n=723) the corresponding numbers of patients were 24 (4%), 22 (3%), 59 (8%), and 106 (15%), respectively (p=0.664, 95% CI 0.72-1.24). 62 (9%) of patients in the azithromycin group and 59 (8%) in the placebo group reached the secondary endpoint of ischaemia or congestive heart failure necessitating admission (difference 0.5%, 95% CI 0.75-1.53; p=0.707). We recorded few side-effects. INTERPRETATION: Short-term treatment with azithromycin does not reduce development of recurrent events in patients with acute coronary syndrome.

Aged↗
PubMed2002

Coronary artery bypass surgery versus percutaneous coronary intervention with stent implantation in patients with multivessel coronary artery disease (the Stent or Surgery trial): a randomised controlled trial.

BACKGROUND: Results of trials, comparing percutaneous transluminal coronary angioplasty (PTCA) with coronary artery bypass grafting (CABG), indicate that rates of death or myocardial infarction are similar with either treatment strategy. Management with PTCA is, however, associated with an increased requirement for subsequent, additional revascularisation. Coronary stents, used as an adjunct to PTCA, reduce restenosis and the need for repeat revascularisation. The aim of the Stent or Surgery (SoS) trial was to assess the effect of stent-assisted percutaneous coronary intervention (PCI) versus CABG in the management of patients with multivessel disease. METHODS: In 53 centres in Europe and Canada, symptomatic patients with multivessel coronary artery disease were randomised to CABG (n=500) or stent-assisted PCI (n=488). The primary outcome measure was a comparison of the rates of repeat revascularisation. Secondary outcomes included death or Q-wave myocardial infarction and all-cause mortality. Analysis was by intention to treat. FINDINGS: All patients were followed-up for a minimum of 1 year and the results are expressed for the median follow-up of 2 years. 21% (n=101) of patients in the PCI group required additional revascularisation procedures compared with 6% (n=30) in the CABG group (hazard ratio 3.85, 95% CI 2.56-5.79, p<0.0001). The incidence of death or Q-wave myocardial infarction was similar in both groups (PCI 9% [n=46], CABG 10% [n=49]; hazard ratio 0.95, 95% CI 0.63-1.42, p=0.80). There were fewer deaths in the CABG group than in the PCI group (PCI 5% [n=22], CABG 2% [n=8]; hazard ratio 2.91, 95% CI 1.29-6.53, p=0.01). INTERPRETATION: The use of coronary stents has reduced the need for repeat revascularisation when compared with previous studies that used balloon angioplasty, though the rate remains significantly higher than in patients managed with CABG. The apparent reduction in mortality with CABG requires further investigation.

Angioplasty, Balloon, Coronary↗
PubMed2005

The Release Trial: a randomised controlled trial of umbilical vein oxytocin versus placebo for the treatment of retained placenta.

HYPOTHESIS: Intraumbilical injection of oxytocin reduces the incidence of manual removal compared with placebo in the treatment of retained placenta. ENTRY CRITERIA: The women recruited will be stable haemodynamically, not bleeding vaginally, over 34 weeks of gestation and with a retained placenta for at least 30 minutes. TREATMENT ARMS: Oxytocin (50 IU) or sterile water (in identical vials) in 25 mL saline injected through an intraumbilical venous catheter. SAMPLE SIZE: Five hundred seventy-two women. PRIMARY ENDPOINT: Need for manual removal of placenta. CENTRES: Initially, there will be two study sites in the UK (Liverpool and Sheffield) and five in Uganda (Mulago, Nsambia, Mengo, Rubaga and Arua). FUNDING: World Health Organization and WellBeing of Women.

Adult↗
PubMed2006

Fatigue Intervention by Nurses Evaluation--the FINE Trial. A randomised controlled trial of nurse led self-help treatment for patients in primary care with chronic fatigue syndrome: study protocol. [ISRCTN74156610].

BACKGROUND: Chronic fatigue syndrome, also known as ME (CFS/ME), is a condition characterised primarily by severe, disabling fatigue, of unknown origin, which has a poor prognosis and serious personal and economic consequences. Evidence for the effectiveness of any treatment for CFS/ME in primary care, where most patients are seen, is sparse. Recently, a brief, pragmatic treatment for CFS/ME, based on a physiological dysregulation model of the condition, was shown to be successful in improving fatigue and physical functioning in patients in secondary care. The treatment involves providing patients with a readily understandable explanation of their symptoms, from which flows the rationale for a graded rehabilitative plan, developed collaboratively with the therapist. The present trial will test the effectiveness and cost-effectiveness of pragmatic rehabilitation when delivered by specially trained general nurses in primary care. We selected a client-centred counselling intervention, called supportive listening, as a comparison treatment. Counselling has been shown to be as effective as cognitive behaviour therapy for treating fatigue in primary care, is more readily available, and controls for supportive therapist contact time. Our control condition is treatment as usual by the general practitioner (GP). METHODS AND DESIGN: This study protocol describes the design of an ongoing, single-blind, pragmatic randomized controlled trial of a brief (18 week) self-help treatment, pragmatic rehabilitation, delivered by specially trained nurse-therapists in patients' homes, compared with nurse-therapist delivered supportive listening and treatment as usual by the GP. An economic evaluation, taking a societal viewpoint, is being carried out alongside the clinical trial. Three adult general nurses were trained over a six month period to deliver the two interventions. Patients aged over 18 and fulfilling the Oxford criteria for CFS are assessed at baseline, after the intervention, and again one year later. Primary outcomes are self-reported physical functioning and fatigue at one year, and will be analysed on an intention-to-treat basis. A qualitative study will examine the interventions' mechanisms of change, and also GPs' drivers and barriers towards referral.

Clinical Protocols↗
PubMed2001

Misoprostol versus dinoprostone for cervical priming prior to induction of labour in term pregnancy: a randomised controlled trial.

A prospective randomised controlled trial was performed to compare the efficacy and safety of intravaginal misoprostol to that of intravaginal dinoprostone when used for cervical priming prior to the induction of labour; 126 women were recruited to the study and randomised to receive either intravaginal dinoprostone (n = 63) or misoprostol (n = 63) for cervical priming prior to induction of labour. The mean time from insertion of the priming agent to vaginal delivery was significantly shorter in the misoprostol group (925.8 versus 1577.6 minutes), the mean duration of the active length of labour was significantly shorter in the misoprostol group (353.7 versus 496.8 minutes) and more women in the misoprostol group delivered in less than 12 hours (92% versus 76.5%). Women in the misoprostol group were less likely to require a repeated dose of prostaglandin for cervical priming and less likely to require oxytocin for augmentation of labour. There was no difference in the number of women who were delivered vaginally or by Ceasarean section between the two groups. More women developed hyperstimulation during labour in the misoprostol group; however there was no difference between the groups in neonatal outcome in respect to low cord pH or Apgar score at delivery or admission to the neonatal special care nursery.

Adult↗
PubMed2005

Comparison of two peri-wound skin protectants in venous leg ulcers: a randomised controlled trial.

OBJECTIVE: A randomised controlled trial was designed to determine whether or not early intervention with a suitable skin barrier preparation could prevent skin breakdown. This study was conducted to compare the efficacy and cost-effectivenss of two skin protectants, Cavilon No Sting Barrier Film (NSBF) (3M Health Care) and zinc paste compound, in the management of maceration and irritation of the peri-wound area of venous leg ulcers. METHOD: Thirty-five patients with venous leg ulcers and surrounding skin problems were randomised to receive either NSBF or zinc paste compound. The preparation was then applied at each dressing change for 12 weeks. All patients had been receiving compression bandaging before entering the study and continued wearing it throughout the 12-week study period. RESULTS: The decrease in wound area was 5.11+/-8.39cm2 in the NSBF group and 4.59+/-5.83cm2 in the zinc paste group. The healing rate was 0.046cm per week with NSBF and 0.039cm per week with zinc paste. There was a significant difference in the time required to remove and re-apply the skin protectants: an average of 0.19 (+/-0.17) minutes in the NSBF group and 5.53 (+/-2.10) minutes in the zinc paste group (p<0.0001). CONCLUSION: Both products were effective barrier preparations. However, NSBF was easy to apply and transparent. The zinc paste was messy to apply and difficult to remove, and thus took up considerably more nursing time than NSBF. DECLARATION OF INTEREST: This study was supported by 3M Health Care.

Aged↗
PubMed1980

Somatostatin and cimetidine in peptic-ulcer haemorrhage. A randomised controlled trial.

In a randomised controlled trial somatostatin was compared with cimetidine in the treatment of severe and persistent gastrointestinal bleeding due to peptic ulcer. The study was of a sequential design and lasted 2.5 years, when the designated level of significance had been reached. Of the 20 patients studied, 10 received somotostatin and 10 received cimetidine. In 7 of the 10 pairs of patients somatostatin was more effective than cimetidine; in 2 pairs somatostatin and cimetidine were both ineffective; and in 1 pair they were equally effective. Somatostatin may therefore be suitable for controlling peptic-ulcer bleeding in many patients who are unsuitable for surgery.

Adult↗
PubMed2005

Health-related quality of life in patients with glioblastoma: a randomised controlled trial.

BACKGROUND: A randomised controlled trial of radiotherapy alone versus radiotherapy with concomitant and adjuvant temozolomide for patients with glioblastoma showed that survival was higher for patients assigned combination treatment compared with those assigned standard radiotherapy alone. This paper reports the health-related quality of life (HRQOL) of the patients in this trial. METHODS: 573 patients with newly diagnosed glioblastoma were randomly allocated either radiotherapy alone or radiotherapy and temozolomide. The primary endpoint was survival, and HRQOL was a secondary endpoint. We assessed HRQOL at baseline and at every 3 months during treatment until progression using the European Organisation for Research and Treatment of Cancer (EORTC) quality of life questionnaire core-30 (QLQ-C30) and the EORTC brain cancer module (EORTC BN-20). We calculated changes from baseline score for seven predefined HRQOL measures (fatigue, overall health, social function, emotional function, future uncertainty, insomnia, and communication deficit) and differences between groups for these measures at every time point. The significance of, and proportions of patients with, improved HRQOL scores--defined as a change of 10 points or more--were recorded. This trial is registered on the US National Cancer Institute website http://www.cancer.gov/search/NewClinicalTrials, NCT00006353. FINDINGS: Baseline questionnaires were available for 490 (86%) patients. Baseline HRQOL scores did not differ between groups. At first follow-up, groups differed only in social functioning, favouring the radiotherapy-only group (mean score 79.0 [SD 3.2] for patients assigned radiotherapy vs 67.4 [2.7] for those assigned radiotherapy and temozolomide; difference between groups 11.6 points [95% CI 3.5-19.7], p=0.0052). Over subsequent assessments, HRQOL was much the same between treatment groups. INTERPRETATION: Addition of temozolomide during and after radiotherapy for patients with newly diagnosed glioblastoma significantly improved survival without a negative effect on HRQOL.

Activities of Daily Living↗
PubMed2005

Oronasopharyngeal suction versus no suction in normal, term and vaginally born infants: a prospective randomised controlled trial.

This prospective randomised controlled trial aimed to compare the effects of oronasopharyngeal suction with those of no suction in normal, term and vaginally born infants and was performed at a Turkish tertiary hospital from June 2003 to January 2004. A total of 140 newborns were enrolled in the trial (n = 70 per group). The no suction group showed lower mean heart rates through the 3rd and 6th minutes and higher SaO(2) values through the first 6 mins of life (P < 0.001). The maximum time to reach SaO2 of >or= 92% (6 vs. 11 min) and >or= 86% (5 vs. 8 min) were shorter in the no suction group (P < 0.001).

Adult↗
PubMed1978

Cimetidine for recurrent ulcer after vagotomy or gastrectomy: a randomised controlled trial.

In a randomised controlled trial cimetidine 1 g daily for six weeks was compared with placebo in the treatment of recurrent ulcers after gastrectomy or vagotomy for duodenal ulcer. Healing, assessed endoscopically, was seen in seven out of 12 patients given cimetidine and in five out of 12 controls. Four of the controls whose ulcers did not heal were subsequently treated with cimetidine, and in two the ulcers healed after six weeks. Pain recorded by the patient and consumption of alkalis were each slightly but not significantly less in the cimetidine-treated patients. When cimetidine is to be used for recurrent ulceration probably the dosage and duration of treatment should be increased.

Cimetidine↗
PubMed2006

Cognitive-behavioural therapy for substance use disorders in people with psychotic disorders: Randomised controlled trial.

BACKGROUND: Few randomised controlled trials have been aimed specifically at substance use reduction among people with psychotic disorders. AIMS: To investigate whether a 10-session intervention consisting of motivational interviewing and cognitive-behavioural therapy (CBT) was more efficacious than routine treatment in reducing substance use and improving symptomatology and general functioning. METHOD: A community sample of people with a psychotic disorder and who reported hazardous alcohol, cannabis and/or amphetamine use during the preceding month was recruited. Participants were randomly allocated to motivational interviewing/CBT (n = 65) or treatment as usual (n = 65), and were assessed on multiple outcomes at baseline, 15 weeks, 6 months and 12 months. RESULTS: There was a short-term improvement in depression and a similar trend with regard to cannabis use among participants who received the motivational interviewing/CBT intervention, together with effects on general functioning at 12 months. There was no differential benefit of the intervention on substance use at 12 months, except for a potentially clinically important effect on amphetamine use. CONCLUSIONS: The motivational interviewing/CBT intervention was associated with modest improvements.

Adolescent↗