The major drawback of taking aspirin is the possibility of severe GI bleeding. This article summarises a comprehensive HEAT clinical study that was conducted to determine whether or not the elimination of H. pylori would offer protection against the bleeding linked to aspirin-related ulcers.

Aspirin is one of the most widely used medicines in the world, and with good reason. Patients with heart disease have relied on aspirin to prevent cardiovascular events for decades. Blood thinning medications like aspirin may help avoid cardiovascular events like heart attacks and strokes.

Aspirin raises the risk of severe gastrointestinal bleeding by 60%, according to a 2021 clinical research of 19,114 people aged 70 or older. Infection with the stomach bacteria Helicobacter pylori has been linked to developing peptic ulcers in people using modest doses of aspirin (often up to 100 mg daily, but may exceed 325 mg daily).

Peptic ulcers, or open sores in the stomach and duodenal lining, may develop as a consequence of an H. pylori infection. The anti-clotting actions of low-dose aspirin were thought by doctors to increase the risk of bleeding from these stomach ulcers.

A genuine concern: Need of the hour

1. An extensive clinical investigation was carried out in order to examine whether or not the eradication of H. pylori would protect against the bleeding associated with aspirin-related ulcers.
2. The trial was directed by researchers from the University of Nottingham in the United Kingdom. The findings of this clinical research were just published in The Lancet Journal.
3. This is a large-scale randomised study, and it is the first one of its kind to address the problem of H. pylori eradication to reduce aspirin-related bleeding in the gastrointestinal tract.
4. In light of this, it is a praiseworthy effort to tackle the problem at hand and investigate potential solutions to the problem of gastrointestinal bleeding.

HEAT clinical study: H. pylori eradication aspirin trial

The study included individuals aged 60 and above with a positive urea breath test for H. pylori during screening from September 2012 to November 2017 at 1,208 primary care clinics in the United Kingdom. If a patient was on an ulcer treatment or a gastroprotective drug, they were not included.

1. Just 5.3%, or 5,367, of the 30,166 people who were examined really had H. pylori.
2. 5352 of these patients were randomly assigned to receive either an H. pylori eradication medication consisting of oral clarithromycin 500 mg, metronidazole 400 mg, and lansoprazole 30 mg (2,677 participants) or an oral placebo (2,675 participants), to be taken twice a day for a week.

Participants, healthcare professionals, and researchers were all blinded to whether they were receiving active eradication or a placebo during the course of the trial. Health outcomes were tracked for a median of 5 years by analysing the individuals' electronic health records.

The duration of protection

The probability of hospitalisation due to ulcer bleeding decreased significantly after H. pylori eradication, as predicted. Peptic ulcer bleeding occurred in six people in the H. pylori eradication group and seventeen people in the placebo group. In a surprising turn of events, it seemed that the preventive effect of H. pylori eradication was gone after just 2.5 years.

According to the researchers, this is "a discovery that has not been noticed previously," therefore it's important enough to look into more.

It may seem counterintuitive that an antibiotic treatment of just one week might have lasting effects, yet this is a known property of Helicobacter pylori. Researchers believe that the pathogen is often picked up in early adulthood after having been latent throughout childhood and adolescence.

Reinfection is very uncommon if the infection is eliminated in adulthood. Ten per cent of participants were retested by the researchers, and 91 per cent of them had negative H. pylori breath tests.

Resulting ramifications in clinical practice 

1. Nowadays, proton-pump inhibitors or histamine H2-receptor antagonists are recommended for long-term aspirin users to lessen the possibility of gastrointestinal bleeding.
2. The HEAT research proved that a different or supplementary gastroprotective method is possible: eradicating H. pylori with a short course of antibiotics.
3. Statistical evidence demonstrated unambiguously that a clinically relevant benefit after H. pylori eradication medication lasted for at least 2.5 years, and persisted after just one week of treatment.
4. Prolonged preventive treatment with a proton-pump inhibitor may seem preferable to H. pylori eradication therapy, but in actual clinical practice, doctors won't give them to people who take aspirin for low risk since it's neither evidence-based nor cost-effective.
5. One such difficulty is getting patients to take proton-pump inhibitors as part of a lifetime of co-therapy. So, for a large group of average- to low-risk aspirin users who would otherwise not get any stomach protective medicine, test-and-treat H. pylori is an advantageous, acceptable, and cost-effective treatment.

Because of advances in medicine, we believe that the risks of ulcer bleeding are now low enough to warrant considering a more liberal use of aspirin to examine impacts on health, including cancer.

In the HEAT study, the authors write,

"Develops a paradigm that may be utilised to analyse other important clinical concerns in primary care."

Disclaimer- The views and opinions expressed in this article are those of the author and do not necessarily reflect the official policy or position of M3 India.

About the author of this article: Dr Monish Raut is a practising super specialist from New Delhi.