Research interests
Helicobacter Eradication Aspirin Trial (HEAT)
The problem (importance)
Aspirin has many therapeutic effects with one major drawback-its link to increased risk of bleeding. It is estimated that there are 25,000 inpatient referrals for gastric bleeds each year with the majority being in the over 60’s. These have been attributed to aspirin but in the presence of the bacterium Helicobacter pylori the risk increases by a further 10%. H. pylori is thought to be present in up to 50% of the population but the majority are asymptomatic and therefore would not be routinely tested. Conversely some experts think that H. pylori, like other bacteria living in our gut, may be good for us however, as yet no definitive advantage has been found.
Screening large numbers of over 60’s prescribed low dose aspirin for the bacterium will identify subjects who can be monitored periodically throughout the trial for subsequent incidence of gastric bleeds. The hypothesis is that by eradicating the bacterium there will be a reduction in gastric bleeding to improve quality of life whilst providing a monetary saving to the NHS.
The approach
The study is a large simple randomised controlled trial recruiting participants from general medical practices throughout England, Wales and Northern Ireland. Subjects are identified by the use of a bespoke web based trial management system, with the capability of running regular notes reviews of the consented participant records saving resources and providing timely data. Participants are invited to clinic to conduct a breath test to identify the presence of H. pylori. Positive subjects are randomised to a placebo or usual care triple eradication therapy as recommended in the BNF.
Findings (trustworthiness)
The study has consented over 19,513 participants to date revealing an 18% positive rate. Recruitment is planned to continue until August 2016 or until 87 endpoints (adjudicated hospital admissions for gastric bleeds) have occurred. The target recruitment is set at 33,000 consented participants. As yet, no adjudicated endpoints have been verified although potential cases are currently under review.
Consequences (significance)
Gastric bleeding continues to increase over time and therefore a suitable and cost effective solution needs to be identified. It is anticipated that the findings of this trial will show that eradicating H. pylori using a low cost therapy will result in a reduction of reported ulcer bleeds in the over 60’s taking a low daily dose of aspirin.
REDUCE
There is considerable concern about increasing antidepressant use in England. GPs are giving out more than 50 million prescriptions a year, to more than 1 in 10 adults.
Some people need long-term antidepressants to stop them getting depressed, but a third to a half could probably stop them without relapsing. However, stopping is not easy, due to withdrawal symptoms including anxiety and low mood which are usually temporary but feel similar to the reason why patients were first put on antidepressants. So understandably some people restart their antidepressant quickly. Others are reluctant to try stopping because they feel well on medication and are afraid their symptoms may come back.
People taking antidepressants have told us their GPs often do not review them and just give repeat prescriptions. Studies show that when GPs review patients on long-term antidepressants and advise them where appropriate to withdraw, only 1 in 14 is able to stop. Patients can be fearful and withdrawal can be tricky so GPs and Nurse Practitioners (NPs) who prescribe anti-depressants need to guide patients who want to withdraw, and patients need around the clock support.
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We aim to identify feasible, safe, reliable and cost-effective (value for money) ways of helping patients withdraw from long-term antidepressants, where this is appropriate.
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We will first review all published relevant research, to identify successful ways to help patients withdraw from treatment.
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We will identify the difficulties in withdrawing, and things that patients and practitioners think might help withdrawal, through interviews with patients taking antidepressants long-term, and through focus groups with GPs, NPs and primary care mental health workers (PCMHWs).
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We will try out support through the Internet for patients, and their GPs, to help them.
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An interactive programme will be developed to help support patient withdrawal from antidepressants, available around the clock.
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It will be developed through a process of 'co-design' and 'coproduction' which means taking the views of patients and practitioners into account throughout its development and initial trial run.
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We will also explore whether 'buddying' support from people who have come off antidepressants might help.
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We will check the usefulness of the programme in helping patients stop treatment through a randomised controlled trial in three centres, and estimate financial benefits for the NHS.
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If the programme works we will spread it throughout the NHS, by publishing practical guidance for professionals, and advice for patients to follow, publicised through patient support groups.
We have developed the ideas for this project with the help of people having long-term treatment for depression. They will continue to work with us to help make sense of the information we gather, and advise on the support we develop for antidepressant withdrawal, from the patient’s point of view.
Please visit the
Primary Care
website.
Research group
Primary Care, Population Sciences and Medical Education
Research project(s)
Ms Wendy O’Brien
Primary Medical Care and Population Sciences
Faculty of Medicine
University of Southampton
Aldermoor Health Centre
Aldermoor Close
Southampton SO16 5ST
Tel: 02380 591754
Fax: 02380 701125
Email:
[email protected]
Room Number :
9500 SGH/Southampton Clinical Trials Unit/S1
