RANDOMIZED TRIAL OF ERADICATION OF HELICOBACTER-PYLORI BEFORE NONSTEROIDAL ANTIINFLAMMATORY DRUG-THERAPY TO PREVENT PEPTIC-ULCERS

Background Helicobacter pylori infection is common in patients with pe ptic ulcers caused by the use of nonsteroidal anti-inflammatory drugs (NSAIDs). But the pathogenic role of H pylori in this disease is contr oversial. We studied the efficacy of eradication of H pylori in the pr evention of NSAID-induced peptic ulcers. Methods We recruited patients with musculoskeletal pain who required NSAID treatment, None of the p atients had previous exposure to NSAID therapy. Patients who had H pyl ori infection but no pre-existing ulcers on endoscopy were randomly al located naproxen alone (750 mg daily) for 8 weeks or a 1-week course o f triple therapy (bismuth subcitrate 120 mg, tetracycline 500 mg, metr onidazole 400 mg, each given orally four times daily) before administr ation of naproxen (750 mg daily). Endoscopy was repeated after 8 weeks of naproxen treatment or when naproxen treatment was stopped early be cause of bleeding or intractable dyspepsia. All endoscopic examination s were done by one endoscopist who was unaware of treatment assignment . The primary endpoint was the cumulative rate of gastric and duodenal ulcers, Findings 202 patients underwent endoscopic screening for enro lment in the trial, and 100 eligible patients were randomly assigned t reatment. 92 patients completed the trial (47 in the naproxen group, 4 5 in the triple-therapy group), At 8 weeks, H pylori had been eradicat ed from no patients in the naproxen group and 40 (89%) in the triple-t herapy group (p<0.001). 12 (26%) naproxen-group patients developed ulc ers: five had ulcer pain and one developed ulcer bleeding. Only three (7%) patients on triple therapy had ulcers, and two of these patients had failure of H pylori eradication (p=0.01). Thus, 12 (26%) patients with persistent H pylori infection but only one (3%) with successful H pylori eradication developed ulcers with naproxen (p=0.002). Interpre tation Eradication of H pylori before NSAID therapy reduces the occurr ence of NSAID-induced peptic ulcers.