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Results for “Randomised Controlled Trial”

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PubMed1996

Adequacy of cervical cytology sampling with the Cervex brush and the Aylesbury spatula: a population based randomised controlled trial.

OBJECTIVE: To compare the adequacy of cervical cytology sampling with two sampling instruments commonly used in primary care-namely, the Aylesbury spatula and the Cervex brush. DESIGN: Pair matched, population based randomised controlled trial. SETTING: 86 general practices and family planning clinics in Greater Manchester. SUBJECTS: 15 882 cervical smears taken from women aged 20-64 years as part of the national cervical screening programme. INTERVENTIONS: Participating centres were allocated to sample with either the Cervex brush or the Aylesbury spatula. MAIN OUTCOME MEASURE: Inadequate smear rate. RESULTS: 5.4% and 5.5% (433/8086 and 426/7796) of smears taken with the Cervex brush and the Aylesbury spatula respectively were reported as inadequate (odds ratio 0.95; 95% confidence interval 0.74 to 1.22). CONCLUSION: The Cervex brush offers no advantage over the Aylesbury spatula in reducing inadequate smear rates in the primary care setting.

Adult↗

PubMed2001

Randomised controlled trial of Helicobacter pylori testing and endoscopy for dyspepsia in primary care.

OBJECTIVE: To determine the cost effectiveness of a strategy of near patient Helicobacter pylori testing and endoscopy for managing dyspepsia. DESIGN: Randomised controlled trial. SETTING: 31 UK primary care centres. PARTICIPANTS: 478 patients under 50 years old presenting with dyspepsia of longer than four weeks duration. INTERVENTIONS: Near patient testing for H pylori and open access endoscopy for patients with positive results. Control patients received acid suppressing drugs or specialist referral at general practitioner's discretion. MAIN OUTCOME MEASURES: Cost effectiveness based on improvement in symptoms and use of resources at 12 months; quality of life. RESULTS: 40% of the study group tested positive for H pylori. 45% of study patients had endoscopy compared with 25% of controls. More peptic ulcers were diagnosed in the study group (7.4% v 2.1%, P=0.011). Paired comparison of symptom scores and quality of life showed that all patients improved over time with no difference between study and control groups. No significant differences were observed in rates of prescribing, consultation, or referral. Costs were higher in the study group ( 367.85 pound sterling v 253.16 pound sterling per patient). CONCLUSIONS: The test and endoscopy strategy increases endoscopy rates over usual practice in primary care. The additional cost is not offset by benefits in symptom relief or quality of life.

Adolescent↗

PubMed2001

Conservative management of persistent postnatal urinary and faecal incontinence: randomised controlled trial.

OBJECTIVES: To assess the effect of nurse assessment with reinforcement of pelvic floor muscle training exercises and bladder training compared with standard management among women with persistent incontinence three months postnatally. DESIGN: Randomised controlled trial with nine months' follow up. SETTING: Community intervention in three centres (Dunedin, New Zealand; Birmingham; Aberdeen). PARTICIPANTS: 747 women with urinary incontinence three months postnatally, allocated at random to intervention (371) or control (376) groups. INTERVENTION: Assessment by nurses of urinary incontinence with conservative advice on pelvic floor exercises at five, seven, and nine months after delivery supplemented with bladder training if appropriate at seven and nine months. MAIN OUTCOME MEASURES: Primary: persistence and severity of urinary incontinence 12 months after delivery. Secondary: performance of pelvic floor exercises, change in coexisting faecal incontinence, wellbeing, anxiety, and depression. RESULTS: Women in the intervention group had significantly less urinary incontinence: 167/279 (59.9%) v 169/245 (69.0%), difference 9.1% (95% confidence interval 1.0% to 17.3%, P=0.037) for any incontinence and 55/279 (19.7%) v 78/245 (31.8%), difference 12.1% (4.7% to 19.6%, P=0.002) for severe incontinence. Faecal incontinence was also less common: 12/273 (4.4%) v 25/237 (10.5%), difference 6.1% (1.6% to 10.8%, P=0.012). At 12 months women in the intervention group were more likely to be performing pelvic floor exercises (218/278 (79%) v 118/244 (48%), P<0.001). CONCLUSIONS: A third of women may have some urinary incontinence three months after childbirth. Conservative management provided by nurses seems to reduce the likelihood of urinary and coexisting faecal incontinence persisting 12 months postpartum. Further trials for faecal incontinence are needed.

Adult↗

PubMed2003

Secondary prevention clinics for coronary heart disease: four year follow up of a randomised controlled trial in primary care.

OBJECTIVES: To evaluate the effects of nurse led clinics in primary care on secondary prevention, total mortality, and coronary event rates after four years. DESIGN: Follow up of a randomised controlled trial by postal questionnaires and review of case notes and national datasets. SETTING: Stratified, random sample of 19 general practices in north east Scotland. PARTICIPANTS: 1343 patients (673 intervention and 670 control) under 80 years with a working diagnosis of coronary heart disease but without terminal illness or dementia and not housebound. INTERVENTION: Nurse led secondary prevention clinics promoted medical and lifestyle components of secondary prevention and offered regular follow up for one year. MAIN OUTCOME MEASURES: Components of secondary prevention (aspirin, blood pressure management, lipid management, healthy diet, exercise, non-smoking), total mortality, and coronary events (non-fatal myocardial infarctions and coronary deaths). RESULTS: Mean follow up was at 4.7 years. Significant improvements were shown in the intervention group in all components of secondary prevention except smoking at one year, and these were sustained after four years except for exercise. The control group, most of whom attended clinics after the initial year, caught up before final follow up, and differences between groups were no longer significant. At 4.7 years, 100 patients in the intervention group and 128 in the control group had died: cumulative death rates were 14.5% and 18.9%, respectively (P=0.038). 100 coronary events occurred in the intervention group and 125 in the control group: cumulative event rates were 14.2% and 18.2%, respectively (P=0.052). Adjusting for age, sex, general practice, and baseline secondary prevention, proportional hazard ratios were 0.75 for all deaths (95% confidence intervals 0.58 to 0.98; P=0.036) and 0.76 for coronary events (0.58 to 1.00; P=0.049) CONCLUSIONS: Nurse led secondary prevention improved medical and lifestyle components of secondary prevention and this seemed to lead to significantly fewer total deaths and probably fewer coronary events. Secondary prevention clinics should be started sooner rather than later.

Adult↗

PubMed2003

Randomised controlled trial of smoking cessation intervention after admission for coronary heart disease.

OBJECTIVE: To determine whether a nurse led smoking cessation intervention affects smoking cessation rates in patients admitted for coronary heart disease. DESIGN: Randomised controlled trial. SETTING: Cardiac ward of a general hospital, Norway. PARTICIPANTS: 240 smokers aged under 76 years admitted for myocardial infarction, unstable angina, or cardiac bypass surgery. 118 were randomly assigned to the intervention and 122 to usual care (control group). INTERVENTION: The intervention was based on a booklet and focused on fear arousal and prevention of relapses. The intervention was delivered by cardiac nurses without special training. The intervention was initiated in hospital, and the participants were contacted regularly for at least five months. MAIN OUTCOME MEASURE: Smoking cessation rates at 12 months determined by self report and biochemical verification. RESULTS: 12 months after admission to hospital, 57% (n = 57/100) of patients in the intervention group and 37% (n = 44/118) in the control group had quit smoking (absolute risk reduction 20%, 95% confidence interval 6% to 33%). The number needed to treat to get one additional person who would quit was 5 (95% confidence interval, 3 to 16). Assuming all dropouts relapsed at 12 months, the smoking cessation rates were 50% in the intervention group and 37% in the control group (absolute risk reduction 13%, 0% to 26%). CONCLUSION: A smoking cessation programme delivered by cardiac nurses without special training, significantly reduced smoking rates in patients 12 months after admission to hospital for coronary heart disease.

Adult↗

PubMed2005

A randomised controlled trial of postural interventions for prevention of musculoskeletal symptoms among computer users.

AIMS: To examine the effect of two workstation and postural interventions on the incidence of musculoskeletal symptoms among computer users. METHODS: Randomised controlled trial of two distinct workstation and postural interventions (an alternate intervention and a conventional intervention) among 376 persons using computer keyboards for more than 15 hours per week. The incidence of neck/shoulder symptoms and hand/arm symptoms during six months of follow up among individuals in the intervention groups was compared to the incidence in computer users who did not receive an intervention (comparison group). For individuals in the intervention groups, study staff adjusted workstations, where possible, and trained individuals to assume the intervention postures. Individuals reported musculoskeletal symptoms in a weekly diary. Participants who reported discomfort intensity of 6 or greater on a 0-10 visual analogue scale or who reported musculoskeletal symptoms requiring use of analgesic medication were considered symptomatic. RESULTS: There were no significant differences in the incidence of musculoskeletal symptoms among the three intervention groups. Twenty two (18.5%) participants in the alternate intervention group, 25 (20.2%) in the conventional intervention group, and 25 (21.7%) in the comparison group developed incident arm or hand symptoms. Thirty eight (33.3%) participants in the alternate intervention group, 36 (31.0%) in the conventional intervention group, and 33 (30.3%) in the comparison group developed incident neck or shoulder symptoms. Compliance with all components of the intervention was attained for only 25-38% of individuals, due mainly to the inflexibility of workstation configurations. CONCLUSIONS: This study provides evidence that two specific workplace postural interventions are unlikely to reduce the risk of upper extremity musculoskeletal symptoms among computer users.

Adolescent↗

PubMed2006

Does a "Level I Evidence" rating imply high quality of reporting in orthopaedic randomised controlled trials?

BACKGROUND: The Levels of Evidence Rating System is widely believed to categorize studies by quality, with Level I studies representing the highest quality evidence. We aimed to determine the reporting quality of Randomised Controlled Trials (RCTs) published in the most frequently cited general orthopaedic journals. METHODS: Two assessors identified orthopaedic journals that reported a level of evidence rating in their abstracts from January 2003 to December 2004 by searching the instructions for authors of the highest impact general orthopaedic journals. Based upon a priori eligibility criteria, two assessors hand searched all issues of the eligible journal from 2003-2004 for RCTs. The assessors extracted the demographic information and the evidence rating from each included RCT and scored the quality of reporting using the reporting quality assessment tool, which was developed by the Cochrane Bone, Joint and Muscle Trauma Group. Scores were conducted in duplicate, and we reached a consensus for any disagreements. We examined the correlation between the level of evidence rating and the Cochrane reporting quality score. RESULTS: We found that only the Journal of Bone and Joint Surgery - American Volume (JBJS-A) used a level of evidence rating from 2003 to 2004. We identified 938 publications in the JBJS-A from January 2003 to December 2004. Of these publications, 32 (3.4%) were RCTs that fit the inclusion criteria. The 32 RCTs included a total of 3543 patients, with sample sizes ranging from 17 to 514 patients. Despite being labelled as the highest level of evidence (Level 1 and Level II evidence), these studies had low Cochrane reporting quality scores among individual methodological safeguards. The Cochrane reporting quality scores did not differ significantly between Level I and Level II studies. Correlations varied from 0.0 to 0.2 across the 12 items of the Cochrane reporting quality assessment tool (p > 0.05). Among items closely corresponding to the Levels of Evidence Rating System criteria assessors achieved substantial agreement (ICC = 0.80, 95% CI:0.60 to 0.90). CONCLUSION: Our findings suggest that readers should not assume that 1) studies labelled as Level I have high reporting quality and 2) Level I studies have better reporting quality than Level II studies. One should address methodological safeguards individually.

Bibliometrics↗

PubMed1994

A randomised controlled trial of a dietary advice program for relatives of heart attack victims.

OBJECTIVE: To compare two interventions for reducing dietary fat intake in first degree relatives of recent heart attack victims. DESIGN: A randomised controlled trial comparing a low cost mail-out advice program; referral to a general practitioner (GP); and no intervention (control group). PARTICIPANTS: Adult children or siblings, aged less than 70 years, of survivors of definite or suspected heart attack who had been admitted to hospitals in the Lower Hunter Region of New South Wales. MAIN OUTCOME MEASURES: Dietary fat intake (evaluated with a validated short questionnaire) and measurement of blood cholesterol levels at six months. RESULTS: Of the 342 relatives who participated (36% of those invited), 109, 120 and 113, respectively, were randomly assigned to receive a mail-out intervention, advice from their GP or to be part of a control group. The six-month follow-up questionnaire was completed by only 59% of those in the mail-out intervention group compared with 71% of the GP group and 77% of the control group. Younger participants, cigarette smokers and children (compared with siblings) were less likely to return a follow-up questionnaire. The mail-out group showed a statistically significant 20% reduction in self-reported dietary fat intake, but this was not seen in either the GP group or the controls. The low response rate meant the study had insufficient power to detect hypothesised changes in blood cholesterol. CONCLUSION: Because of the poor response rate and possible biases from a differential response to follow-up, we conclude that this low intensity intervention for relatives of people with recent heart attack produces only a modest improvement in reported dietary fat intake. Alternative strategies may be more effective in reducing the risk of heart disease.

Adult↗

PubMed1995

Gastric emptying in acute overdose: a prospective randomised controlled trial.

OBJECTIVE: To test the hypothesis that administration of activated charcoal is as efficacious and safe as the combination regimen of gastric emptying plus charcoal in adults after acute oral overdose. DESIGN: Prospective randomised controlled trial, with subjects presenting on odd-numbered dates allocated to the emptied group (E), and those on even-numbered dates to the not-emptied group (NE). SETTING: Princess Alexandra Hospital, Brisbane (a tertiary referral hospital), which serves an adult urban community, between 4 January 1988 and 11 June 1990. SUBJECTS: Consecutive patients (13 years or older) who presented to the Emergency Department after ingesting an overdose of one or more compounds able to be adsorbed by activated charcoal. INTERVENTIONS: All patients received charcoal by the oral or nasogastric route. Those in the E group also had gastric emptying by ipecac-induced emesis or gastric lavage. OUTCOME MEASURES: Clinical course during the first six hours after treatment began, length of hospital stay, complications. RESULTS: 876 patients were eligible for the study. There were no significant differences between the E and NE groups in age and sex distribution, severity of the overdose or other characteristics, except the mean interval between presentation and administration of charcoal (91 min [SD, 52] for E group and 55 [SD, 41] for NE group; P = 0.0001). There were no significant differences between the E and NE groups in outcome, even when the groups were stratified for severity of the overdose or into subgroups that presented sooner or later than one hour after ingestion. CONCLUSIONS: Gastric emptying can be omitted from the treatment protocol for adults after acute oral overdose.

Adolescent↗

PubMed2001

Randomised controlled trial to change the hospital management of unstable angina.

OBJECTIVES: To examine the benefits of a guideline-based educational program to improve management of unstable angina pectoris (UAP) in hospital patients. DESIGN: Randomised controlled trial. SETTING: 37 public hospitals across New South Wales. PATIENTS: 1,872 patients admitted with a diagnosis of UAP between 1 February and 30 June 1996 (baseline survey), and 1,368 patients with the same diagnosis admitted between 1 July and 31 December 1998 (follow-up survey). INTERVENTION: Educational sessions run by local opinion leaders, presenting guidelines on management of UAP from the National Health and Medical Research Council and feedback on local practice using data from the baseline survey. Sessions were run between March and June 1998. MAIN OUTCOME MEASURES: Use of evidence-based practice, identified by review of medical records. RESULTS: Use of beta-blockers increased in intervention and control hospitals, although the increase was significant only in the former. Use of calcium-channel blockers decreased significantly in both intervention and control hospitals. However, the change in drug use between baseline and follow-up did not differ significantly between intervention and control hospitals. CONCLUSIONS: Despite some appropriate changes in drug use for UAP management between 1996 and 1998, there was no evidence that a guideline-based educational program was of benefit in changing management. This reaffirms the difficulty of changing doctors' behaviour through practice guidelines. Alternative methods of encouraging evidence-based practice should be considered.

Adrenergic beta-Antagonists↗

PubMed2001

Lowering the doses of mifepristone and gameprost for early abortion: a randomised controlled trial. World Health Organization Task Force on Post-ovulatory Methods for Fertility Regulation.

OBJECTIVE: To test the efficacy of lower doses of mifepristone and gemeprost for medical induction of early abortion. DESIGN: Randomised controlled trial. Participants were blinded as to the therapy and physicians to the dose of mifepristone. SETTING: Thirteen hospital gynaecological units in different continents. PARTICIPANTS: 1,224 healthy pregnant women requesting medical abortion at <57 days from last menses. INTERVENTION: Random allocation to one of four regimens: mifepristone 50 mg by mouth followed by either 0.5 mg or 1.0 mg gemeprost vaginally on day 3; mifepristone 200 mg by mouth followed by either 0.5 mg or 1.0 mg gemeprost vaginally. We concealed the allocation sequence from clinicians enrolling participants, and maintained double blinding throughout. MAIN OUTCOME MEASURES: Incidence of complete abortion; subordinate outcome measures included side effects such as vomiting and fall in haemoglobin, as well as the need for emergency curettage and blood transfusion. RESULTS: The success rate was significantly related to the dose of mifepristone. The relative risk of failure to have a complete abortion with the lower dose of mifepristone was 1.6 (95% CI: 1.1-2.3) times that with the higher dose. The relative risk of failure with the lower dose of gemeprost (1.3; 95% CI: 0.9-1.8) did not reach statistical significance. CONCLUSIONS: A single dose of mifepristone 50 mg followed by gemeprost is inadequate for early medical abortion. There was no significant difference in side effects between the four treatment groups.

Abortifacient Agents, Nonsteroidal↗

PubMed1993

Mid-trimester termination of pregnancy--a randomised controlled trial of two prostaglandin regimens.

OBJECTIVE: To determine the more applicable of two ways of prostaglandin induction currently in use in second trimester induced abortions for congenital or chromosomal abnormalities. DESIGN: A prospective randomised controlled trial. SETTING: Department of Obstetrics and Gynaecology, Tygerberg Hospital, CP. STUDY POPULATION: Twenty consecutive patients admitted for termination of pregnancy for congenital or chromosomal abnormalities between 14 and 26 weeks' pregnancy duration. MANAGEMENT: Patients were randomly selected to receive either 1.5 mg prostaglandin E2 (PGE2) gel extra-amniotically or 25 mg prostaglandin F2 alpha (PGF2 alpha) intra-amniotically. Patients in both groups received oxytocin to a maximum dosage of 120 mU per minute if they had not aborted 18 hours after the original administration of either prostaglandin regimen. If abortion had not taken place 36 hours after commencement of treatment, management was considered unsuccessful. MAIN OUTCOME MEASUREMENTS: Proportion of successful inductions and complications. RESULTS: Complications of management were rare and did not differ between the two management groups. However, there were significantly more failures in the group who received intra-amniotic PGF2 alpha (7 v. 2 patients) as well as a significantly higher need for oxytocin in this group (10 v. 4 patients). CONCLUSIONS: With promising drugs such as prostaglandin analogues and anti-progesterones not universally available, methods of induction suitable to the local situation should be sought. Extra-amniotic PGE2 seems more suitable than intra-amniotic PGF2 alpha because of a shorter induction-to-delivery time without increased morbidity.

Abortion, Induced↗

PubMed1999

Randomised controlled trial of educational package on management of menorrhagia in primary care: the Anglia menorrhagia education study.

OBJECTIVE: To determine whether an educational package could influence the management of menorrhagia, increase the appropriateness of choice of non-hormonal treatment, and reduce referral rates from primary to secondary care. DESIGN: Randomised controlled trial. SETTING: General practices in East Anglia. SUBJECTS: 100 practices (348 doctors) in primary care were recruited and randomised to intervention (54) and control (46). INTERVENTIONS: An educational package based on principles of "academic detailing" with independent academics was given in small practice based interactive groups with a visual presentation, a printed evidence based summary, a graphic management flow chart, and a follow up meeting at 6 months. OUTCOME MEASURES: All practices recorded consultation details, treatments offered, and outcomes for women with regular heavy menstrual loss (menorrhagia) over 1 year. RESULTS: 1001 consultation data sheets for menorrhagia were returned. There were significantly fewer referrals (20% v 29%; odds ratio 0. 64; 95% confidence interval 0.41 to 0.99) and a significantly higher use of tranexamic acid (odds ratio 2.38; 1.61 to 3.49) in the intervention group but no overall difference in norethisterone treatment compared with controls. There were more referrals when tranexamic acid was given with norethisterone than when it was given alone. Those practices reporting fewer than 10 cases showed the highest increase in prescribing of tranexamic acid. CONCLUSIONS: The educational package positively influenced referral for menorrhagia and treatment with appropriate non-hormonal drugs.

Anti-Inflammatory Agents, Non-Steroidal↗

PubMed2006

Prevention of HIV and sexually transmitted diseases in high risk social networks of young Roma (Gypsy) men in Bulgaria: randomised controlled trial.

OBJECTIVE: To determine the effects of a behavioural intervention for prevention of HIV and sexually transmitted diseases that identified, trained, and engaged leaders of Roma (Gypsy) men's social networks to counsel their own network members. DESIGN: A two arm randomised controlled trial. SETTING: A disadvantaged, impoverished Roma settlement in Bulgaria. PARTICIPANTS: 286 Roma men from 52 social networks recruited in the community. INTERVENTION: At baseline all participants were assessed for HIV risk behaviour, tested and treated for sexually transmitted diseases, counselled in risk reduction, and randomised to intervention or control groups. Network leaders learnt how to counsel their social network members on risk prevention. Networks were followed up three and 12 months after the intervention to determine evidence of risk reduction. MAIN OUTCOME MEASURE: Occurrence of unprotected intercourse during the three months before each assessment. RESULTS: Reported prevalence of unprotected intercourse in the intervention group fell more than in control group (from 81% and 80%, respectively, at baseline to 65% and 75% at three months and 71% and 86% at 12 months). Changes were more pronounced among men with casual partners. Effects remained strong at long term follow-up, consistent with changes in risk reduction norms in the social network. Other measures of risk reduction corroborated the intervention's effects. CONCLUSIONS: Endorsement and advice on HIV prevention from the leader of a social network produces well maintained change in the reported sexual practices in members of that network. This model has particular relevance for health interventions in populations such as Roma who may be distrustful of outsiders. TRIAL REGISTRATION: Clinical Trials NCT00310973.

Adult↗

PubMed1998

Treatment of severe malaria with artemisinin derivatives. A systematic review of randomised controlled trials.

This systematic review of randomised or pseudorandomised trials aimed at summarising the effectiveness and safety of artemisinin drugs for treating severe falciparum malaria in adults and children. Survival was better with artemisinin drugs in 1.265 patients compared with 1.183 treated with quinine (OR: 0.68; 95% CI: 0.55-0.84). However, the difference is barely significant when only studies with adequate concealment of allocation at enrolment are included in the analysis (OR: 0.77; 95% CI: 0.61-0.98). In 1784 patients with cerebral malaria, mortality was also lower with artemisinin drugs overall (OR: 0.70; 95% CI: 0.55-0.90), but not significantly better than quinine in studies reporting adequate concealment of allocation. No difference in neurological sequelae has been demonstrated. Artemisinin drugs clear parasites from the blood faster than quinine. Adverse effects are similarly common with artemisinin drugs and quinine, although reporting varies between trials. There is no evidence from this review that any one artemisinin derivative is better than the others, but comparative studies are few, small and heterogeneous.

Adult↗

PubMed1999

Behavioural management in nursing and residential homes: a randomised controlled trial.

BACKGROUND: As more and more elderly people are being cared for in residential and nursing homes, how best can their psychiatric needs be met? We report on evaluation of a behavioural intervention by an old-age psychiatry hospital outreach team. METHODS: This randomised controlled trial of a training and education intervention over 6 months was done in south Manchester, UK. 12 matched nursing and residential homes were randomised to the control or intervention group and within each, the staff selected 10 residents whose behavioural problems made them difficult to care for. Care staff in the intervention homes attended seminars from the hospital outreach team and received weekly visits from a psychiatric nurse to assist in developing care planning skills. The main outcome measures were cognitive impairment and depression, behavioural disturbance, and functional ability, assessed by the geriatric mental state schedule, Crichton Royal behaviour rating scale, and Barthel index, respectively. FINDINGS: Residents in the intervention group had significantly improved scores for depression (before-and-after change difference -0.5 [95% CI -0.8 to -0.1]) and for cognitive impairment (-0.7 [-1.1 to -0.2]) but not for behaviour rating or Barthel index. INTERPRETATION: Elderly residents can benefit from improved quality of care achieved by training from a hospital outreach team.

Aged↗

PubMed2001

Randomised controlled trial of prophylactic etamsylate: follow up at 2 years of age.

AIM: To assess the role of etamsylate in reducing the risk of haemorrhagic brain damage and its consequences. DESIGN: Follow up of babies recruited into a randomised controlled trial. METHODS: A total of 334 infants born before 33 weeks gestation in France and Greece were randomly allocated within the first four hours of birth either to receive etamsylate or to act as controls. The principal outcomes in the trial were death or impairment and/or disability at the age of 2 years. RESULTS: Fifty nine children were lost to follow up. A total of 115 (34%) either died or had some impairment or disability, and 88 (26%) either died or had severe impairment or disability at 2 years of age. These outcomes did not differ significantly between the two randomised groups: relative risks and 95% confidence intervals 1.14 (0.78 to 1.4) and 1.17 (0.82 to 1.68) respectively. The findings were similar for all the prespecified subgroup analyses stratified by key prognostic factors at trial entry: country of birth, gestational age < or >or= 29 weeks, inborn or outborn, age < or >or= 1 hour, and with or without cerebral scan abnormality. CONCLUSION: These findings do not support the use of etamsylate. Other strategies need to be evaluated for the prevention of mortality and morbidity in these vulnerable infants.

Child Health Services↗

PubMed2003

Nutritional enhancement of exercise performance in chronic obstructive pulmonary disease: a randomised controlled trial.

BACKGROUND: Pulmonary rehabilitation is effective in improving exercise performance and health status in chronic obstructive pulmonary disease (COPD). However, the role of nutritional support in the enhancement of the benefits of exercise training has not been explored. A double blind, randomised, controlled trial of carbohydrate supplementation was undertaken in patients attending outpatient pulmonary rehabilitation. METHODS: 85 patients with COPD were randomised to receive a 570 kcal carbohydrate rich supplement or a non-nutritive placebo daily for the duration of a 7 week outpatient pulmonary rehabilitation programme. Primary outcome measures were peak and submaximal exercise performance using the shuttle walk tests. Changes in health status, body composition, muscle strength, and dietary macronutrient intake were also measured. RESULTS: Patients in both the supplement and placebo groups increased shuttle walking performance and health status significantly. There was no statistically significant difference between treatment groups in these outcomes. Patients receiving placebo lost weight whereas supplemented patients gained weight. In well nourished patients (BMI >19 kg/m(2)) improvement in incremental shuttle performance was significantly greater in the supplemented group (mean difference between groups: 27 (95% CI 1 to 53) m, p<0.05). Increases in incremental shuttle performance correlated with increases in total carbohydrate intake. CONCLUSIONS: When universally prescribed, carbohydrate supplementation does not enhance the rehabilitation of patients with COPD. This study suggests that exercise training results in negative energy balance that can be overcome by supplementation and that, in selected patients, this may improve the outcome of training. The finding of benefit in well nourished patients may suggest a role for nutritional supplementation beyond the treatment of weight loss in COPD.

Aged↗