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New study provides clarification about the effects of drugs used to prevent and treat peptic ulcers. Gastroprotectant drugs, in particular the class of drug known as proton pump inhibitors (PPIs) reduce the risk of peptic ulcer disease and its complications, and promote healing of peptic ulcers in a wide range of clinical circumstances, according to research published in today’s Lancet Gastroenterology and Hepatology. The study was also discussed in an editorial by Ernst J Kuipers.

Peptic ulcer disease is a common condition worldwide, and occurs when a break develops in the lining of the stomach or the first part of the gut. This can lead to an open sore, due to damage from the acid which is naturally produced by the stomach, in turn leading to abdominal pain and other symptoms such as indigestion, heartburn and poor appetite. It can also progress to serious (and sometimes fatal)  complications such as bleeding from the site of the ulcer into the gut (known as upper gastrointestinal bleeding), part of the stomach or intestine splitting open (known as perforation) or, rarely, a blockage of the stomach outlet.

The most common causes of peptic ulcer disease are an infection with a bacterium known as Helicobacter pylori, or taking non-steroidal anti-inflammatory drugs (NSAIDs), such as ibuprofen or aspirin (particularly if they're taken for a long time or at high doses). NSAIDs are very widely used, for example ibuprofen is often used in osteoarthritis, and aspirin in heart disease, and so many people are potentially at risk of peptic ulcer disease.

Researchers at the MRC Population Health Research Unit at the University of Oxford (MRC PHRU) have undertaken what they believe is the world’s largest meta-analysis (in terms of the number of trials) to look at the effects of gastroprotectants in detail. The scientists combined data from more than 1,200 randomised trials, including more than 200,000 patients worldwide.

The results show that gastroprotectant drugs can more than halve the risk of developing peptic ulcer disease (irrespective of whether people were also taking a nonsteroidal anti-inflammatory drug, such as ibuprofen or aspirin) and more than treble the healing of existing peptic ulcers. In patients presenting with acute upper gastrointestinal bleeding, treatment reduces the risk of further bleeding by about one third. In all scenarios, PPIs generally appeared to be superior to other gastroprotectant treatments.

“This study provides strong evidence that gastroprotectants are highly effective in the prevention and treatment of peptic ulcer disease and its complications,” said Professor Colin Baigent, Head of the MRC PHRU, who led the work.

Concerns about possible heart risks of gastroprotectants have limited the use of gastroprotectants to date, particularly in some patient groups such as the elderly on aspirin-based therapies following a heart attack, despite the risk of upper gastrointestinal bleeding in such patients being high.  “Although this study was not able to examine any side effects of gastroprotectant in detail due to a lack of data availability, new trial data are anticipated in the near future, which should help address this issue more definitively,” said Professor Baigent. 

Several drugs have been developed to prevent and treat peptic ulcer disease. The most commonly used are known as proton pump inhibitors (also called PPIs, such as omeprazole), and histamine-2 receptor antagonists (also called H2 blockers, such as cimetidine and ranitidine) which reduce the amount of acid the stomach produces.  Another kind of drug known as a prostaglandin analogue, which works by protect the lining of the gut, may also be used. Collectively these drugs are often called ‘gastroprotectant drugs’.

Many clinical trials have been carried out to assess the effects of such gastroprotectant drugs. However, most such trials have been small, and there has been a lack of reliable information about the effects of these drugs in different clinical situations.

Since many gastroprotectant drugs are now available cheaply in a generic form, these findings support their use as a potential strategy to reduce the global burden of peptic ulcer disease. Indirectly, they may also help reduce events such as heart attacks in those at high risk of cardiovascular disease, by allowing wider use of aspirin and related therapies.