Andrea Roalfe

Eradication of Helicobacter pylori for non‐ulcer dyspepsia

BACKGROUNDnHelicobacter pylori (H pylori) is the main cause of peptic ulcer disease. The role of H pylori in non-ulcer dyspepsia is less clear.nnnOBJECTIVESnTo determine the effect of H pylori eradication on dyspepsia symptoms in patients with non-ulcer dyspepsia.nnnSEARCH STRATEGYnTrials were identified through electronic searches of the Cochrane Controlled Trials Register (CCTR), MEDLINE, EMBASE, CINAHL and SIGLE, using appropriate subject headings and keywords, searching bibliographies of retrieved articles, and through contacts with experts in the fields of dyspepsia and with pharmaceutical companies.nnnSELECTION CRITERIAnAll parallel group randomised controlled trials (RCTs) comparing drugs to eradicate H pylori with placebo or other drugs known not to eradicate H pylori for patients with non-ulcer dyspepsia.nnnDATA COLLECTION AND ANALYSISnData were collected on individual and global dyspeptic symptom scores, quality of life measures and adverse effects. Dyspepsia outcomes were dichotomised into minimal/resolved versus same/worse symptoms.nnnMAIN RESULTSnTwenty one randomised controlled trials were included in the systematic review. Eighteen trials compared antisecretory dual or triple therapy with placebo antibiotics +/- antisecretory therapy, and evaluated dyspepsia at 3-12 months. Seventeen of these trials gave results as dichotomous outcomes evaluating 3566 patients and there was no significant heterogeneity between the studies. There was a 10% relative risk reduction in the H pylori eradication group (95% CI = 6% to 14%) compared to placebo. The number needed to treat to cure one case of dyspepsia = 14 (95% CI = 10 to 25). A further three trials compared Bismuth based H pylori eradication with an alternative pharmacological agent. These trials were smaller and had a shorter follow-up but suggested H pylori eradication was more effective than either H2 receptor antagonists or sucralfate in treating non-ulcer dyspepsia.nnnAUTHORS CONCLUSIONSnH pylori eradication therapy has a small but statistically significant effect in H pylori positive non-ulcer dyspepsia. An economic model suggests this modest benefit may still be cost-effective but more research is needed.

Randomized Trial of Exercise Therapy in Women Treated for Breast Cancer

PURPOSEnTo examine the effects of aerobic exercise therapy on quality of life (QoL) and associated outcomes in women treated for breast cancer. Evidence suggests that exercise may be beneficial, but no trial has included an exercise-placebo and a usual-care group to control for the attention effects that might be associated with aerobic exercise interventions in cancer patients.nnnPATIENTS AND METHODSnA total of 108 women who had been treated for breast cancer 12 to 36 months previously were randomly assigned to supervised aerobic exercise therapy (n = 34), exercise-placebo (body conditioning; n = 36), or usual care (n = 38). Exercise therapy and exercise-placebo sessions took place three times per week for 8 weeks. Outcomes included QoL, depression, exercise behavior, aerobic fitness; outcomes were assessed at baseline and at the 8- and 24-week follow-up.nnnRESULTSnAnalyses of covariance revealed a significant mean difference of 9.8 units in Functional Assessment of Cancer Therapy-General (primary outcome) favoring aerobic exercise therapy at 8 weeks, relative to usual care. Significant differences that favored aerobic exercise therapy relative to usual care were recorded for Functional Assessment of Cancer Therapy-Breast, social/family well-being, functional well-being, and breast cancer subscale scores at 8-week follow-up. Psychological health outcomes improved modestly for both intervention groups; these improvements were sustained for several end points.nnnCONCLUSIONnExercise therapy had large, clinically meaningful, short-term beneficial effects on QoL in women treated for breast cancer; this finding cannot be attributable to attention, given that the exercise-placebo group did not report similar effects relative to usual care.

Exercise Therapy as a Treatment for Psychopathologic Conditions in Obese and Morbidly Obese Adolescents: A Randomized, Controlled Trial

OBJECTIVE. We conducted a proof-of-concept, randomized, controlled trial to investigate the effects of a supervised exercise therapy intervention on psychopathologic outcomes in obese adolescents. METHODS. The participant sample consisted of 81 adolescents (age: 11–16 years) who had been referred to a childrens hospital for evaluation of obesity or who responded to a community advertisement. Participants were assigned randomly to exercise therapy, an equal-contact exercise placebo intervention, or usual care. Intervention participants attended 3 one-on-one sessions per week for 8 weeks and then completed a home program for another 6 weeks. Outcomes included self-perceptions (self-esteem), depression, affect, physical activity, aerobic fitness, and BMI. RESULTS. A total of 18 of 81 participants were categorized as morbidly obese (BMI SD score: >3.5; adult equivalent BMI: ≥40). At baseline, 30.3% of participants had a Childrens Depression Inventory score of ≥13, and 27% reported recent suicidal ideation. Repeated-measures mixed analysis of covariance (controlling for baseline scores) revealed significant changes in physical self-worth, associated measures of self-esteem, and physical activity over time, consistently favoring exercise therapy. There were no significant changes in BMI. CONCLUSIONS. Findings confirmed psychopathologic conditions as a serious health concern in obese and morbidly obese adolescents. Our study is the first randomized, controlled trial to demonstrate that a brief supervised exercise therapy intervention has the potential to improve psychopathologic outcomes significantly and to increase physical activity in obese adolescents, relative to usual care.

The Effects of Exercise upon Symptoms and Quality of Life in Patients Diagnosed with Irritable Bowel Syndrome : A Randomised Controlled Trial

While it seems intuitively appealing to promote participation in regular exercise in the management of irritable bowel syndrome, limited randomised controlled trial evidence exists to support this recommendation. We examined the feasibility and effects of an exercise intervention upon quality of life and irritable bowel symptoms using a randomised controlled trial methodology. Patients with a clinically confirmed diagnosis of irritable bowel syndrome according to Rome II criteria were randomised to either an exercise consultation intervention or usual care for 12 weeks. Outcomes included irritable bowel specific quality of life, symptoms (total symptoms, constipation, diarrhoea and pain) and exercise participation. The recruitment rate of eligible patients identified from hospital records was 18.3% (56/305). Analyses revealed no differences in quality life scores between groups at 12-week follow-up. The exercise group reported significantly improved symptoms of constipation (mean difference=10.9, 95 % CI= -20.1, -1.6) compared to usual care at follow-up. The intervention group participated in significantly more exercise than usual care at follow-up (mean difference=21.6, 95% CI=9.4, 33.8). Recruitment of eligible patients into this study was possible but rates were low. Findings highlight the possibility that exercise may be an effective intervention for symptom management in patients with irritable bowel syndrome; this may be particularly the case for constipation predominant patients.

Pragmatic intervention for increasing self-directed exercise behaviour and improving important health outcomes in people with multiple sclerosis: A randomised controlled trial

Background: Exercise programmes that can demonstrate evidence of long-lasting clinical effectiveness are needed for people with multiple sclerosis (PwMS). Objective: The objective of this study was to assess the effects of a practically implemented exercise programme on self-directed exercise behaviour and important health outcomes in PwMS to nine months of follow-up. Methods: We conducted a parallel-arm, randomised controlled trial: 120 PwMS (Expanded Disability Status Scale (EDSS) 1.0–6.5) randomised to a three-month exercise intervention plus usual care, or usual care only. Two supervised plus one home-exercise session (weeks 1–6) were followed by one supervised and two home-exercise sessions (weeks 7–12). Cognitive-behavioural techniques promoted long-term exercise behaviour change. Outcomes were blindly assessed at baseline and at three and nine months after randomisation. The primary outcome was self-reported exercise behaviour (Godin Leisure Time Exercise Questionnaire (GLTEQ)). Secondary outcomes included fatigue and health-related quality of life (HRQoL). Results: The intervention increased self-reported exercise (9.6 points; 95% CI: 2.0 to 17.3 points; p = 0.01) and improved fatigue (p < 0.0001) and many HRQoL domains (p ≤ 0.03) at three months. The improvements in emotional well-being (p = 0.01), social function (p = 0.004) and overall quality of life (p = 0.001) were sustained for nine months. Conclusion: This pragmatic approach to implementing exercise increases self-reported exercise behaviour, improves fatigue and leads to a sustained enhancement of HRQoL domains in PwMS.

A randomised controlled trial to determine the effect on response of including a lottery incentive in health surveys (ISRCTN32203485)

BackgroundPostal questionnaires are an economical and simple method of data collection for research purposes but are subject to non-response bias. Several studies have explored the effect of monetary and non-monetary incentives on response. Recent meta-analyses conclude that financial incentives are an effective way of increasing response rates. However, large surveys rarely have the resources to reward individual participants. Three previous papers report on the effectiveness of lottery incentives with contradictory results. This study aimed to determine the effect of including a lottery-style incentive on response rates to a postal health survey.MethodsRandomised controlled trial. Setting: North and West Birmingham. 8,645 patients aged 18 or over randomly selected from registers of eight general practices (family physician practices). Intervention: Inclusion of a flyer and letter with a health questionnaire informing patients that returned questionnaires would be entered into a lottery-style draw for £100 of gift vouchers. Control: Health questionnaire accompanied only by standard letter of explanation. Main outcome measures: Response rate and completion rate to questionnaire.Results5,209 individuals responded with identical rates in both groups (62.1%). Practice, patient age, sex and Townsend score (a postcode based deprivation measure) were identified as predictive of response, with higher response related to older age, being female and living in an area with a lower Townsend score (less deprived).ConclusionThis RCT, using a large community based sample, found that the offer of entry into a lottery style draw for £100 of High Street vouchers has no effect on response rates to a postal health questionnaire.

What women want? Exercise preferences of menopausal women

BACKGROUNDnMany menopausal women are keen to find alternatives to HRT; exercise might be useful in this regard but more trial evidence is required. Before we conduct such trials however, it is important to understand the exercise preference of these women so that appropriate exercise interventions can be developed for inclusion in such trials.nnnAIMnTo investigate the exercise preferences of menopausal women and to examine the association between exercise levels, BMI, and hot flushes/night sweats in this population.nnnMETHODnParticipants were women aged 46-55 years from eight diverse general practices in Birmingham. A postal questionnaire containing items about demographics, lifestyle behaviours, weight, height, menopausal status, frequency of hot flushes/night sweats and preferences for exercise was sent to all eligible women.nnnRESULTSn1693/2776 (61.0%) of women replied. The majority (75.9%) of respondents stated that exercise was an acceptable intervention. The most commonly chosen option for delivery of exercise interventions was by one-to-one consultations with a fitness advisor, followed by DVD sent by post. Telephone based interventions and e-Health interventions (i.e. Internet and mobile phone text messages) were the interventions least chosen. There was also an overwhelming choice for walking as a mode of exercise. A series of two factor analyses of covariance indicated exercise participation and BMI were not significantly related to frequency of hot flushes/night sweats in symptomatic menopausal women.nnnCONCLUSIONnMenopausal women have strong preferences to receive exercise interventions that involve one-to-one contact with a fitness advisor or by exercise DVD. The use of more recent technology to deliver exercise interventions was highly unpopular. These findings should be considered in future studies when planning exercise interventions with this population.

Pragmatic exercise intervention for people with multiple sclerosis (ExIMS Trial) : study protocol for a randomised controlled trial

Exercise is an effective intervention for improving function, mobility and health-related quality of life in people with multiple sclerosis (PwMS). Questions remain however, regarding the effectiveness of pragmatic exercise interventions for evoking tangible and sustained increases in physical activity and long-term impact on important health outcomes in PwMS. Furthermore, dose-response relationships between exercise and health outcomes have not previously been reported in PwMS. These issues, and improved knowledge of cost effectiveness, are likely to influence key decisions of health policy makers regarding the implementation of exercise therapy as part of the patient care pathway for PwMS. Hence, the primary aim of this study is to investigate whether a 12-week tapered programme of supervised exercise, incorporating cognitive-behavioural techniques to facilitate sustained behaviour change, is effective for evoking improvements in physical activity and key health outcomes in PwMS over 9 months of follow-up. A total of 120 PwMS will be randomised (1:1) to either a 12-week pragmatic exercise therapy intervention or usual care control group. Participants will be included on the basis of a clinical diagnosis of MS, with an expanded disability status score (EDSS) between 1 and 6.5. Outcome measures, to be assessed before and after the intervention and 6 months later, will include physical activity, clinical and functional measures and health-related quality of life. In addition, the cost effectiveness of the intervention will be evaluated and dose-response relationships between physical activity and the primary/secondary outcomes in those with mild and more severe disease will be explored.

Antibiotic prescribing by single handed general practitioners: Secondary analysis of data

Aim: To determine the contribution of various doctor and patient factors on the frequency of antibiotic prescribing.

Aerobic exercise as a treatment for vasomotor menopausal symptoms: Randomised controlled trial protocol

BACKGROUNDnEvidence suggests that a high proportion of perimenopausal and postmenopausal women experience vasomotor symptoms (hot flushes/night sweats) that can be severe and disruptive and which are the principal reason for seeking medical intervention. Hormone therapy (HT) is known to be an effective treatment for troublesome hot flushes/night sweats but research has raised questions about the safety of HT and there have been negative high profile media reports about its use. Consequently many women are seeking alternatives and exercise might be one such option but there is a lack of high quality evidence on its effectiveness.nnnAIMSnThis RCT initially aims to investigate the feasibility/acceptability of two exercise interventions identified from our previous preference study in 165 women, and if found to be feasible/acceptable, continue to recruit sufficient women (n=261) to examine the effect of these interventions on hot flushes/night sweats and other outcomes relevant to menopausal women.nnnMETHODnWe aim to recruit inactive perimenopausal and menopausal symptomatic women not using HT and randomise them to one of two exercise interventions or usual care for six months.nnnRESULTSnWe will assess outcomes at baseline and 6 and 12 months from randomisation.nnnCONCLUSIONnWe hope this RCT will contribute towards increasing the evidence regarding the question of whether exercise is an effective treatment for vasomotor symptoms in women not taking HT.