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Results for “Randomised Controlled Trial”

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PubMed2002

Treating Helicobacter pylori infection in primary care patients with uninvestigated dyspepsia: the Canadian adult dyspepsia empiric treatment-Helicobacter pylori positive (CADET-Hp) randomised controlled trial.

OBJECTIVE: To determine whether a "test for Helicobacter pylori and treat" strategy improves symptoms in patients with uninvestigated dyspepsia in primary care. DESIGN: Randomised placebo controlled trial. SETTING: 36 family practices in Canada. PARTICIPANTS: 294 patients positive for H pylori ((13)C- urea breath test) with symptoms of dyspepsia of at least moderate severity in the preceding month. INTERVENTION: PARTICIPANTS were randomised to twice daily treatment for 7 days with omeprazole 20 mg, metronidazole 500 mg, and clarithromycin 250 mg or omeprazole 20 mg, placebo metronidazole, and placebo clarithromycin. Patients were then managed by their family physicians according to their usual care. MAIN OUTCOME MEASURES: Treatment success defined as no symptoms or minimal symptoms of dyspepsia at the end of one year. Societal healthcare costs collected prospectively for a secondary evaluation of actual mean costs. RESULTS: In the intention to treat population (n=294), eradication treatment was significantly more effective than placebo in achieving treatment success (50% v 36%; P=0.02; absolute risk reduction=14%; number needed to treat=7, 95% confidence interval 4 to 63). Eradication treatment cured H pylori infection in 80% of evaluable patients. Treatment success at one year was greater in patients negative for H pylori than in those positive for H pylori (54% v 39%; P=0.02). Eradication treatment reduced mean annual cost by $C53 (-86 to 180) per patient. CONCLUSIONS: A "test for H pylori with (13)C-urea breath test and eradicate" strategy shows significant symptomatic benefit at 12 months in the management of primary care patients with uninvestigated dyspepsia.

Adolescent↗

PubMed1999

No effect of bipolar interferential electrotherapy and pulsed ultrasound for soft tissue shoulder disorders: a randomised controlled trial.

OBJECTIVE: To assess the efficacy of bipolar interferential electrotherapy (ET) and pulsed ultrasound (US) as adjuvants to exercise therapy for soft tissue shoulder disorders (SD). METHODS: Randomised placebo controlled trial with a two by two factorial design plus an additional control group in 17 primary care physiotherapy practices in the south of the Netherlands. Patients with shoulder pain and/or restricted shoulder mobility, because of a soft tissue impairment without underlying specific or generalised condition, were enrolled if they had not recovered after six sessions of exercise therapy in two weeks. They were randomised to receive (1) active ET plus active US; (2) active ET plus dummy US; (3) dummy ET plus active US; (4) dummy ET plus dummy US; or (5) no adjuvants. Additionally, they received a maximum of 12 sessions of exercise therapy in six weeks. Measurements at baseline, 6 weeks and 3, 6, 9, and 12 months later were blinded for treatment. OUTCOME MEASURES: recovery, functional status, chief complaint, pain, clinical status, and range of motion. RESULTS: After written informed consent 180 patients were randomised: both the active treatments were given to 73 patients, both the dummy treatments to 72 patients, and 35 patients received no adjuvants. Prognosis of groups appeared similar at baseline. Blinding was successfully maintained. At six weeks seven patients (20%) without adjuvants reported very large improvement (including complete recovery), 17 (23%) and 16 (22%) with active and dummy ET, and 19 (26%) and 14 (19%) with active and dummy US. These proportions increased to about 40% at three months, but remained virtually stable thereafter. Up to 12 months follow up the 95% CI for differences between groups for all outcomes include zero. CONCLUSION: Neither ET nor US prove to be effective as adjuvants to exercise therapy for soft tissue SD.

Adult↗

PubMed1993

The gastrointestinal toxicity of aspirin: an overview of randomised controlled trials.

The proven benefit of aspirin in the secondary prevention of cardiovascular disease and its possible value in primary prevention must be weighted against its potential hazards. This paper is an overview of the gastrointestinal toxicity of aspirin, its most serious complication after intracerebral haemorrhage. Information on toxicity has been drawn only from randomised trials, thus avoiding the potential biases of observational studies. All randomised placebo controlled trials listed in the Anti-platelet Trialists Collaboration where a direct aspirin-placebo comparison was possible were included. Twenty-one trials were included, all but one of secondary prevention. There were over 75,000 person years of aspirin exposure. The pooled odds ratios for categories of gastrointestinal bleeding (e.g. haematemesis, melaena) were between 1.5-2.0; fatal bleeds were very rare. The risk of peptic ulcers was 1.3 and of upper gastrointestinal symptoms 1.7. These risks were lower than those found in observational studies. Attributable disease rates are also presented. For haematemesis for example they varied from 0.2-1.0 per 1000 person years. Toxicity was dose related. Aspirin does have significant gastrointestinal toxicity, although this is rarely fatal. More recent work has demonstrated the efficacy of low doses of aspirin (75 mg daily) but there is limited information yet available on its toxicity.

Aged↗

PubMed2000

Local anaesthetic effect of topical amethocaine gel in neonates: randomised controlled trial.

AIM: To assess the efficacy of amethocaine as a topical local anaesthetic in neonates. METHODS: A randomised, double blind controlled trial compared 4% amethocaine gel (Ametop) with placebo in 60 healthy neonates (29 to 42 weeks of gestation) in the first week after birth. Either 1.5 g 4% w/w amethocaine (gel) or 1.5 g placebo gel were applied to the dorsum of one foot. No gel was applied to the other foot. Each foot was occluded and left for one hour. Local anaesthesia was then assessed by eliciting the cutaneous withdrawal reflex in response to stimulation with a series of graded nylon filaments (von Frey hairs). The reflex was first elicited from the control and then the treated foot. The difference in filament thickness and deforming weight required to elicit the reflex was recorded. RESULTS: In infants treated with amethocaine, 17 of 31 (54. 8%) showed evidence of local anaesthetic action compared with five of 29 (17.2%) in the placebo group (p=0.003). The mean difference in deforming weight required to elicit the reflex was 18.8 g in the amethocaine group compared with 3.9 g in the placebo group (p=0.02). The apparent local anaesthetic action of the placebo can be explained by habituation to repeated stimulation. CONCLUSIONS: It is concluded that topical amethocaine gel has a local anaesthetic action on neonatal skin which merits further investigation. An effective and safe surface local anaesthetic would be valuable for the relief of procedure related pain in neonates.

Administration, Cutaneous↗

PubMed2006

Physical activity to prevent obesity in young children: cluster randomised controlled trial.

OBJECTIVE: To assess whether a physical activity intervention reduces body mass index in young children. DESIGN: Cluster randomised controlled single blinded trial over 12 months. SETTING: Thirty six nurseries in Glasgow, Scotland. PARTICIPANTS: 545 children in their preschool year, mean age 4.2 years (SD 0.2) at baseline. INTERVENTION: Enhanced physical activity programme in nursery (three 30 minute sessions a week over 24 weeks) plus home based health education aimed at increasing physical activity through play and reducing sedentary behaviour. MAIN OUTCOME MEASURE: Body mass index, expressed as a standard deviation score relative to UK 1990 reference data. Secondary measures were objectively measured physical activity and sedentary behaviour; fundamental movement skills; and evaluation of the process. RESULTS: Group allocation had no significant effect on the primary outcome measure at six and 12 months or on measures of physical activity and sedentary behaviour by accelerometry. Children in the intervention group had significantly higher performance in movement skills tests than control children at six month follow-up (P=0.0027; 95% confidence interval 0.3 to 1.3) after adjustment for sex and baseline performance. CONCLUSIONS: Physical activity can significantly improve motor skills but did not reduce body mass index in young children in this trial. TRIAL REGISTRATION: Current Controlled Trials ISRCTN36363490.

Body Mass Index↗

PubMed1997

Systematic review of randomised controlled trials of strategies to promote adherence to tuberculosis treatment.

OBJECTIVE: To determine the effectiveness of strategies to promote adherence to treatment for tuberculosis. IDENTIFICATION: Searches in Medline (1966 to August 1996), the Cochrane trials register (up to October 1996), and LILACS (Literatura Latinoamericana y del Caribe en Ciencias de la Salud) (1982 to September 1996); screening of references in articles on compliance and adherence; contact with experts in research on tuberculosis and adherence. INCLUSION CRITERIA: Randomised or pseudorandomised controlled trials of interventions to promote adherence with curative or preventive treatment for tuberculosis, with at least one measure of adherence. MAIN OUTCOME MEASURE: Relative risks and 95% confidence intervals for estimates of effect for categorical outcomes. RESULTS: Five trials met the inclusion criteria. The relative risk for tested reminder cards sent to patients who defaulted on treatment was 1.2 (95% confidence interval 1.1 to 1.4), for help given to patients by lay health workers 1.4 (1.1 to 1.8), for monetary incentives offered to patients 1.6 (1.3 to 2.0), for health education 1.2 (1.1 to 1.4), for a combination of a patient incentive and health education 2.4 (1.5 to 3.7) or 1.1 (1.0 to 1.2), and for intensive supervision of staff in tuberculosis clinics 1.2 (1.1 to 1.3). There were no completed trials of directly observed treatment. All of the interventions tested improved adherence. On current evidence it is unclear whether health education by itself leads to better adherence to treatment. CONCLUSIONS: Reliable evidence is available to show some specific strategies improve adherence to tuberculosis treatment, and these should be adopted in health systems, depending on their appropriateness to practice circumstances. Further innovations require testing to help find specific approaches that will be useful in low income countries. Randomised controlled trials evaluating the independent effects of directly observed treatment are awaited.

Attitude to Health↗

PubMed2006

A randomised controlled trial of the use of a tourniquet to reduce blood loss during transtibial amputation for peripheral arterial disease.

OBJECTIVES: To examine the effects of an exsanguination tourniquet on blood loss during transtibial amputation in patients with peripheral arterial disease (PAD). DESIGN: Prospective randomised blinded controlled trial. MATERIALS AND METHODS: Sixty-four patients undergoing transtibial amputation for non-reconstructible PAD were randomised to either tourniquet or no tourniquet (control). Blood loss (primary outcome), fall in haemoglobin, transfusion requirements, wound healing, breakdown and revision (secondary outcomes) were also recorded. RESULTS: Twenty-five patients in the tourniquet and 29 in the control group conformed to the trial protocol and completed the follow up. Intra-operative blood loss (median and IQR) was significantly greater in the control group compared to the tourniquet group (550 ml (255-1050) vs 255 ml (150-572.5), respectively, p=0.014, Mann-Whitney). There was a significantly greater drop in haemoglobin concentration (median and IQR) in the control compared to the tourniquet group (1.8 g/dl (0-1.2) vs 1.0 g/dl (0.6-2.4), p=0.035, t-test). Transfusion requirements were lower in the tourniquet group (p=0.05, Mann-Whitney). The rate of wound healing, breakdown and revision were similar in the tourniquet and control groups, respectively (59 vs 57%, 0 vs 9%, 14 vs 9%, p=NS). CONCLUSIONS: The use of a tourniquet during transtibial amputation for severe PAD reduces blood loss and need for blood transfusion.

Aged↗

PubMed1996

Deep venous thrombosis prophylaxis with low molecular weight heparin and elastic compression in patients having total hip replacement. A randomised controlled trial.

Seventy-eight patients having elective total hip replacement were randomised into 3 groups A) control; B) low molecular weight heparin: (enoxaparin 40 mg once daily) and C) enoxaparin (40 mg once daily) plus graduated elastic compression (TEDR stockings) for 8-12 days. All patients had a preoperative perfusion lung scan and chest X-Ray and a postoperative perfusion/ventilation scan together with bilateral ascending venography on days 8-12. A blood sample was taken preoperatively, on the 1st, 3rd and 5th postoperative day and at the end of the study. The control group received placebo injections. The venograms and V/Q scans were reported blindly by an independent panel of three and one radiologists respectively. An independent panel of assessors stopped entry in the control group when a total of 45 patients were admitted according to Ethics Committee directives. The study continued with groups B and C. The incidence of DVT (including isolated asymptomatic calf thrombi) was as follows: Group A (n = 14) 93%; Group B (n = 32) 38%; Group C (n = 32) 25% (chi 2; p < 0.001 for group A versus B or C). The incidence of proximal DVT was: Group A 57%; group B 28%; group C 13% (chi 2; p = 0.057 for group A versus B and p < 0.005 for group A versus C). The incidence of silent pulmonary embolism (PE) (new defect on V/Q scan) was 28% (8 out of 29) in patients with and 5% (2 out of 43) in patients without DVT (chi 2; p < 0.02). The combination of high TAT and low anti-Xa activity on the 1st postoperative day identified a high risk group of patients who had a 56% incidence of proximal DVT on the 8th to 12th postoperative day. Further studies are needed to confirm the suggested increased efficacy in prophylaxis by the combination of LMWH and GEC as compared with LMWH alone.

Aged↗

PubMed2004

The PAV trial: does lactobacillus prevent post-antibiotic vulvovaginal candidiasis? Protocol of a randomised controlled trial [ISRCTN24141277].

BACKGROUND: Complementary and alternative medicines are used by many consumers, and increasingly are being incorporated into the general practitioner's armamentarium. Despite widespread usage, the evidence base for most complementary therapies is weak or non-existent. Post-antibiotic vulvovaginitis is a common problem in general practice, for which complementary therapies are often used. A recent study in Melbourne, Australia, found that 40% of women with a past history of vulvovaginitis had used probiotic Lactobacillus species to prevent or treat post-antibiotic vulvovaginitis. There is no evidence that this therapy is effective. This study aims to test whether oral or vaginal lactobacillus is effective in the prevention of post-antibiotic vulvovaginitis. METHODS/DESIGN: A randomised placebo-controlled blinded 2 x 2 factorial design is being used. General practitioners or pharmacists approach non-pregnant women, aged 18-50 years, who present with a non-genital infection requiring a short course of oral antibiotics, to participate in the study. Participants are randomised in a four group factorial design either to oral lactobacillus powder or placebo and either vaginal lactobacillus pessaries or placebo. These interventions are taken while on antibiotics and for four days afterwards or until symptoms of vaginitis develop. Women self collect a vaginal swab for culture of Candida species and complete a survey at baseline and again four days after completing their study medications. The sample size (a total of 496--124 in each factorial group) is calculated to identify a reduction of half in post-antibiotic vulvovaginitis from 23%, while allowing for a 25% drop-out. An independent Data Monitoring Committee is supervising the trial. Analysis will be intention-to-treat, with two pre-specified main comparisons: (i) oral lactobacillus versus placebo and (ii) vaginal lactobacillus versus placebo.

Adult↗

PubMed2001

Radiography of the lumbar spine in primary care patients with low back pain: randomised controlled trial.

OBJECTIVE: To test the hypothesis that radiography of the lumbar spine in patients with low back pain is not associated with improved clinical outcomes or satisfaction with care. DESIGN: Randomised unblinded controlled trial. SETTING: 73 general practices in Nottingham, north Nottinghamshire, southern Derbyshire, north Lincolnshire, and north Leicestershire. 52 practices recruited participants to the trial. SUBJECTS: 421 patients with low back pain of a median duration of 10 weeks. INTERVENTION: Radiography of the lumbar spine. MAIN OUTCOME MEASURES: Roland adaptation of the sickness impact profile, visual analogue scale for pain, health status, EuroQol, satisfaction with care, use of primary and secondary care services, and reporting of low back pain at three and nine months after randomisation. RESULTS: The intervention group were more likely to report low back pain at three months (relative risk 1.26, 95% confidence interval 1.00 to 1.60) and had a lower overall health status score and borderline higher Roland and pain scores. A higher proportion of participants consulted their doctor in the three months after radiography (1.62, 1.33 to 1.97). Satisfaction with care was greater in the group receiving radiography at nine but not three months after randomisation. Overall, 80% of participants in both groups at three and nine months would have radiography if the choice was available. An abnormal finding on radiography made no difference to the outcome, as measured by the Roland score. CONCLUSIONS: Radiography of the lumbar spine in primary care patients with low back pain of at least six weeks' duration is not associated with improved patient functioning, severity of pain, or overall health status but is associated with an increase in doctor workload. Guidelines on the management of low back pain in primary care should be consistent about not recommending radiography of the lumbar spine in patients with low back pain in the absence of indicators for serious spinal disease, even if it has persisted for at least six weeks. Patients receiving radiography are more satisfied with the care they received. The challenge for primary care is to increase satisfaction without recourse to radiography.

Adult↗

PubMed2005

Response to antibiotics of women with symptoms of urinary tract infection but negative dipstick urine test results: double blind randomised controlled trial.

OBJECTIVE: To assess the effectiveness of antibiotic treatment of women with symptoms of urinary tract infection but negative urine dipstick testing. DESIGN: Prospective, double blind, randomised, placebo controlled trial. SETTING: Primary care, among a randomly selected group of general practitioners in Christchurch, New Zealand. PARTICIPANTS: 59 women aged 16-50 years presenting with a history of dysuria and frequency in whom a dipstick test of midstream urine was negative for both nitrites and leucocytes. Participants with complicated urinary tract infection were excluded. INTERVENTION: Trimethoprim 300 mg daily for three days or placebo. MAIN OUTCOME MEASURES: Self reported diary of symptoms for seven days, recording the presence or absence of individual symptoms each day, followed by a structured telephone questionnaire after seven days. The main clinical outcome was resolution of dysuria at three and seven days and median time to resolution. Secondary outcomes were resolution of other symptoms. RESULTS: The median time for resolution of dysuria was three days for trimethoprim compared with five days for placebo (P = 0.002). At day 3, five (24%) of patients in the treatment group had ongoing dysuria compared with 20 (74%) in the placebo group (P = 0.005). This difference persisted until day 7: two patients (10%) in the treatment group v 11 (41%) in the placebo group; P = 0.02). The number needed to treat was 4. The median duration of constitutional symptoms (feverishness, shivers) was reduced by four days. CONCLUSIONS: Although a negative dipstick test for leucocytes and nitrites accurately predicted absence of infection when standard microbiological definitions were used (negative predictive value 92%), it did not predict response to antibiotic treatment. Three days' treatment with trimethoprim significantly reduced dysuria in women whose urine dipstick test was negative. These results support the practice of empirical antibiotic use guided by symptoms. Balancing the competing interests of symptom relief and the minimisation of antibiotic use remains a dilemma-further research is needed to determine clinical predictors of response to antibiotics.

Adolescent↗

PubMed1996

Comparison of effect of cafetière and filtered coffee on serum concentrations of liver aminotransferases and lipids: six month randomised controlled trial.

OBJECTIVE: To study the effects of prolonged intake of cafetière coffee, which is rich in the diterpenes cafestol and kahweol, on serum aminotransferase and lipid concentrations. DESIGN: Randomised parallel controlled trial. SUBJECTS: 46 healthy men and women aged 19 to 69. INTERVENTION: Consumption of five to six strong cups (0.9 litres) a day of either cafetière (22 subjects) or filtered coffee (24 subjects) for 24 weeks. MAIN OUTCOME MEASURES: Mean changes in serum aminotransferase and lipid concentrations. RESULTS: Cafetière coffee raised alanine aminotransferase concentration by up to 80% above baseline values relative to filtered coffee. After 24 weeks the rise was still 45% (9 U/l (95% confidence interval 3 to 15 U/l), P = 0.007). Alanine aminotransferase concentration exceeded the upper limit of normal in eight of the 22 subjects drinking cafetière coffee, being twice the upper limit of normal in three of them. Cafetière coffee raised low density lipoprotein cholesterol concentrations by 9-14%. After 24 weeks the rise was 0.26 mmol/l (0.04 to 0.47 mmol/l) (P = 0.03) relative to filtered coffee. Triglyceride concentrations initially rose by 26% with cafetière coffee but returned close to baseline values within six months. All increases were reversible after the intervention was stopped. CONCLUSIONS: Daily consumption of five to six cups of strong cafetière coffee affects the integrity of liver cells as suggested by small increases in serum alanine aminotransferase concentration. The effect does not subside with prolonged intake. High intakes of coffee brews rich in cafestol and kahweol may thus be responsible for unexplained increases in this enzyme activity in apparently healthy subjects. Cafetière coffee also raises low density lipoprotein cholesterol concentration and thus the risk of coronary heart disease.

Adult↗

PubMed2001

Relation between drug treatment and cancer in hypertensives in the Swedish Trial in Old Patients with Hypertension 2: a 5-year, prospective, randomised, controlled trial.

BACKGROUND: Is cancer related to hypertension and blood pressure? Do antihypertensive drugs promote cancer? Do antihypertensive drugs protect against cancer? We previously analysed the frequency of cardiovascular mortality and morbidity in elderly people who participated in the Swedish Trial in Old Patients with Hypertension 2 (STOP-Hypertension-2). We have also looked at the frequency of cancer in these patients. METHODS: We randomly assigned 6614 elderly patients with hypertension (mean age 76 years, median time of follow-up 5.3 years) to one of three treatment strategies: conventional drugs (diuretics or b-blockers), calcium antagonists, or ACE inhibitors. We matched the patients to the Swedish Cancer Registry and compared our findings with expected values based on age, sex, and calendar-year-specific reference frequencies for the general Swedish population. We also compared the number of cancers between the three treatment groups. FINDINGS: At baseline, 607 (9%) patients had previous malignant disease. Diagnoses were closely similar to the distribution of cancer types that might be seen in elderly patients. During follow-up, there were 625 new cases of cancer in 590 patients. The frequency of cancer did not differ significantly between the treatment strategies, including all cancers and those at individual sites. The standardised incidence ratios (SIRs) for all cancers were also close to unity: 0.92 (95% CI 0.80-1.06) for conventional drugs, 0.96 (0.83-1.10) for calcium antagonists, and 0.99 (0.86-1.13) for ACE inhibitors. INTERPRETATIONS: No difference in cancer risk was seen between patients randomly assigned to conventional drugs, calcium antagonists, or ACE inhibitors. Thus, the general message to the practising physician is that more attention should be given to getting the blood pressure down than to the risk of cancer.

Aged↗

PubMed2006

Clopidogrel plus aspirin versus oral anticoagulation for atrial fibrillation in the Atrial fibrillation Clopidogrel Trial with Irbesartan for prevention of Vascular Events (ACTIVE W): a randomised controlled trial.

BACKGROUND: Oral anticoagulation therapy reduces risk of vascular events in patients with atrial fibrillation. However, long-term monitoring is necessary and many patients cannot achieve optimum anticoagulation. We assessed whether clopidogrel plus aspirin was non-inferior to oral anticoagulation therapy for prevention of vascular events. METHODS: Patients were enrolled if they had atrial fibrillation plus one or more risk factor for stroke, and were randomly allocated to receive oral anticoagulation therapy (target international normalised ratio of 2.0-3.0; n=3371) or clopidogrel (75 mg per day) plus aspirin (75-100 mg per day recommended; n=3335). Outcome events were adjudicated by a blinded committee. Primary outcome was first occurrence of stroke, non-CNS systemic embolus, myocardial infarction, or vascular death. Analyses were by intention-to-treat. This study is registered with ClinicalTrials.gov, number NCT00243178. RESULTS: The study was stopped early because of clear evidence of superiority of oral anticoagulation therapy. There were 165 primary events in patients on oral anticoagulation therapy (annual risk 3.93%) and 234 in those on clopidogrel plus aspirin (annual risk 5.60%; relative risk 1.44 (1.18-1.76; p=0.0003). Patients on oral anticoagulation therapy who were already receiving this treatment at study entry had a trend towards a greater reduction in vascular events (relative risk 1.50, 95% CI 1.19-1.89) and a significantly (p=0.03 for interaction) lower risk of major bleeding with oral anticoagulation therapy (1.30; 0.94-1.79) than patients not on this treatment at study entry (1.27, 0.85-1.89 and 0.59, 0.32-1.08, respectively). CONCLUSION: Oral anticoagulation therapy is superior to clopidogrel plus aspirin for prevention of vascular events in patients with atrial fibrillation at high risk of stroke, especially in those already taking oral anticoagulation therapy.

Aged↗

PubMed2006

Effect of off-pump coronary artery bypass surgery on clinical, angiographic, neurocognitive, and quality of life outcomes: randomised controlled trial.

OBJECTIVE: To compare the clinical, angiographic, neurocognitive, and quality of life outcomes of off-pump coronary artery bypass surgery with conventional coronary artery bypass grafting surgery using cardiopulmonary bypass. DESIGN: Randomised controlled clinical trial. SETTING: Tertiary cardiothoracic centre in Middlesex, England. PARTICIPANTS: 168 patients (27 women) requiring primary isolated coronary artery bypass grafting surgery. INTERVENTIONS: Patients were randomised to conventional coronary artery bypass grafting surgery using cardiopulmonary bypass (n = 84) or off-pump coronary artery bypass surgery (n = 84), carried out by one surgeon. Angiographic examination was carried out at three months postoperatively. Neurocognitive tests were carried out at baseline and at six weeks and six months postoperatively. MAIN OUTCOME MEASURES: Clinical outcome, graft patency at three months, neurocognitive function at six weeks and six months, and health related quality of life. RESULTS: Graft patency was evaluated by angiography in 151 (89.9%) patients and was similar between the cardiopulmonary bypass and off-pump groups (risk difference - 1%, 95% confidence interval - 5% to 4%), with the off-pump group considered the treatment group. Patients in the off-pump group required fewer blood transfusions (1.7 units v 1.0 unit, P = 0.02), shorter duration of mechanical ventilation (7.7 hours v 3.9 hours, P = 0.03), and shorter hospital stay (10.8 days v 8.9 days). Scores for neurocognitive function showed a significant difference in three memory subtests at six weeks and two memory subtests at six months in favour of the off-pump group. CONCLUSIONS: Patients who underwent off-pump coronary artery bypass surgery showed similar patency of grafts, better clinical outcome, shorter hospital stay, and better neurocognitive function than patients who underwent conventional coronary artery bypass grafting surgery using cardiopulmonary bypass.

Cognition Disorders↗

PubMed2006

Can sutures get wet? Prospective randomised controlled trial of wound management in general practice.

OBJECTIVE: To compare standard management of keeping wounds dry and covered with allowing wounds to be uncovered and wet in the first 48 hours after minor skin excision. DESIGN: Prospective, randomised controlled, multicentre trial testing for equivalence of infection rates. SETTING: Primary care in regional centre, Queensland, Australia. PARTICIPANTS: 857 patients randomised to either keep their wound dry and covered (n = 442) or remove the dressing and wet the wound (n = 415). RESULTS: The incidence of infection in the intervention group (8.4%) was not inferior to the incidence in the control group (8.9%) (P < 0.05). The one sided 95% confidence interval for the difference of infection rates was infinity to 0.028. CONCLUSION: These results indicate that wounds can be uncovered and allowed to get wet in the first 48 hours after minor skin excision without increasing the incidence of infection.

Adult↗

PubMed2006

Randomised controlled trial of four commercial weight loss programmes in the UK: initial findings from the BBC "diet trials".

OBJECTIVE: To compare the effectiveness of four commercial weight loss diets available to adults in the United Kingdom. DESIGN: Six month multicentre randomised unblinded controlled trial. SETTING: Community based sample of otherwise healthy overweight and obese adults. INTERVENTIONS: Dr Atkins' new diet revolution, Slim-Fast plan, Weight Watchers pure points programme, and Rosemary Conley's eat yourself slim diet and fitness plan. MAIN OUTCOME MEASURES: Weight and body fat changes over six months. RESULTS: All diets resulted in significant loss of body fat and weight over six months. Groups did not differ significantly but loss of body fat and weight was greater in all groups compared with the control group. In an intention to treat analysis, average weight loss was 5.9 kg and average fat loss was 4.4 kg over six months. The Atkins diet resulted in significantly higher weight loss during the first four weeks, but by the end was no more or less effective than the other diets. CONCLUSIONS: Clinically useful weight loss and fat loss can be achieved in adults who are motivated to follow commercial diets for a substantial period. Given the limited resources for weight management in the NHS, healthcare practitioners should discuss with their patients programmes known to be effective. TRIAL REGISTRATION: Clinical trials NCT00327821.

Adipose Tissue↗

PubMed2006

Side effects of phenobarbital and carbamazepine in childhood epilepsy: randomised controlled trial.

OBJECTIVE: To compare the behavioural side effects associated with two commonly used antiepilepsy drugs-phenobarbital and carbamazepine-in children in Bangladesh. DESIGN: Prospective randomised controlled single centre trial. SETTING: Specialist children's hospital in Dhaka, Bangladesh. PARTICIPANTS: 108 children aged 2-15 with generalised tonic-clonic (n=51) or partial and secondary generalised seizures (n=57). MAIN OUTCOME MEASURES: Seizure control and behavioural side effects. RESULTS: 91 children were followed up for 12 months. Six required a change of antiepilepsy drug. Side effects were compared in 85 children. In the last quarter of the 12 month follow-up, 71 children were seizure free after one year's treatment. Thirty two in the phenobarbital group and 39 in the carbamazepine group had no seizures in 74 and 102 days after randomisation, respectively. Ten children had increased behavioural problems, which were unacceptable in four (one in the phenobarbital group and three in the carbamazepine group). Independent t tests, however, showed no difference between the two trial drugs. CONCLUSION: There was no excess in behavioural side effects with phenobarbital in children with epilepsy in a country with limited resources. Trial registration NCT00381537.

Adolescent↗