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Ulcer prophylaxis is unnecessary with short course NSAIDs

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Patients embarking on a short course of non-steroidal anti-inflammatory drugs (NSAIDs) do not need prophylactic treatment against ulcers, even if they are infected with Helicobacter pylori. That is, according to a large randomised, double blind, multicentre clinical trial.

Researchers carefully selected patients with H pylori infection, with no current/ever peptic ulcer, who needed NSAID treatment for musculoskeletal pain. They tested four parallel, prophylactic treatments to compare eradication of H pylori, or suppression of gastric acid, both, or neither on outcome.

All active treatments significantly reduced ulcers compared with placebo (0-1.2% v 5%), mucosal erosions, and reduced the need for treatment for dyspepsia and were significantly better than placebo on the basis of combined criteria. Treatment to eradicate H pylori or reduce gastric acid was equally effective, but the low proportion of ulcers with placebo suggests that it is unnecessary, the researchers concluded.

From an initial 2264 patients, 832 were randomised to receive one treatment in addition to diclofenac 50 mg twice a day for five weeks. This comprised one week’s triple treatment against H pylori (omeprazole 20 mg, clarithromycin 500 mg, and amoxycillin 1 g, twice a day) then four weeks’ placebo; one week’s triple treatment then four weeks’ omeprazole (20 mg daily); five weeks’ omeprazole (20 mg daily); or five weeks’ placebo. Results were analysed for 660 patients.

Conventional NSAIDs are renowned for gastric problems. Whether H pylori reduces or increases ulcers with NSAIDs can be argued either way, and the evidence that its eradication protects against ulcers is controversial.