Many people are taking aspirin these days and it's got a lot of benefits, but there are some side effects as well - and ulcer bleeding is one of them.
- Mina Davoudianfar, Clinical Trial Manager
More than 1,700 Thames Valley patients have taken part in a major NHS trial that aims to find out whether a course of antibiotics can help to reduce stomach bleeding in aspirin users.
The HEAT study was funded and supported by the National Institute for Health Research (NIHR). It closed last month after recruiting 30,024 participants across the UK.
In low doses, aspirin is used as a long-term treatment to prevent heart attacks and strokes. Researchers on the study believe that by thinning the blood, aspirin makes ulcers in the stomach bleed. These ulcers may be caused by a particular type of bacteria, known as H.pylori, and so the study aims to find out whether a short course of antibiotics to remove this bacteria will reduce the risk of bleeding in aspirin users.
Professor Chris Hawkey, Chief Investigator of the study at the University of Nottingham explained: “Aspirin use is widespread, especially among the elderly, and there is increasing evidence that it may slow down certain cancers. However, a side effect of long-term use can include ulcer bleeding.
“We know interventional trials are influential, however if the outcome being investigated occurs infrequently, studies need to be conducted on a large scale.”
The study was delivered with the involvement of 1,260 general practices across the UK who issued more than 185,000 invitation letters to potential participants aged 60 and over who were daily aspirin users.
In total, 1,712 patients across the Thames Valley were recruited to the study: 504 in Berkshire, 234 in Buckinghamshire, 72 in Milton Keynes and 902 in Oxfordshire.
Once consented to take part in the study, patients were invited to take a breath test to see whether they had H.pylori in their system.
Patients who tested positive for H.pylori were randomised to either receive a week-long course of antibiotics or a placebo treatment.
H.pylori is in the mucus that lines the stomach. More than half of the world’s population have H. pylori but usually do not know they have it because it rarely causes symptoms.
Mina Davoudianfar, Clinical Trial Manager at the University of Oxford’s Nuffield Department of Primary Care Health Sciences's Primary Care Clinical Trials Unit, which is running the study in the Thames Valley area, said: “Many people are taking aspirin these days and it's got a lot of benefits but there are some side effects as well and ulcer bleeding is one of them.
“The hypothesis behind this study is that people who are on a low dose aspirin and have H.pylori bacteria in their stomach are at higher risk of bleeding. If we try to eradicate H.pylori from the stomach, hopefully they’ll have less bleeding.
“It’s a very simple study for GP practices, they only see patients once and that’s it. The patients are sent the medication if they are eligible and the nurses will call them to make sure they’ve got their medication and know how to take it. We then have a follow-up after a few months.
“If we can reduce bleeding for these patients, then we will eventually reduce the number of hospital admissions and this will save the NHS a lot of money as well as benefitting the patients.
“This trial has been a great opportunity for me to work in research because so many practices are on board and so many research nurses have been helping to get recruitment numbers up and we’re very thankful for that.”
Last year, there were almost 17,000 hospital admissions for gastric ulcers and more than 1,850 recorded deaths. If successful, the study will help to reduce NHS costs and improve health outcomes by reducing hospital admissions, increasing patient safety and preventing premature deaths.
Dr Simon Cartwright, a GP at the White Horse Medical Practice in Faringdon, Oxfordshire, which recruited 89 patients, said: “The patients taking part in HEAT are people who have had a stroke or heart attack and we already know that aspirin is effective at reducing the risk of recurrence.
“Gastric bleeds are a well-known side-effect of aspirin in long-term use so the trial has been popular with patients and easy to recruit to in large numbers. Patients don’t currently have many options to prevent gastric bleeding, so they have been happy to participate.”
Participating in health research helps develop new treatments, improve the NHS and save lives. The NIHR supports research by asking patients and healthy volunteers if they wish to take part in trials.
Patients are also encouraged to ask their doctor about research opportunities and view trials seeking volunteers at The UK Clinical Trials Gateway: www.ukctg.nihr.ac.uk.