Helicobacter Eradication Aspirin Trial
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 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.
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.
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.