A prospective, randomized, double-blind trial 1 included 441 consequtive patients from a single centre who were taking non-selective NSAIDs for arthritis and were admitted for upper gastrointestinal bleeding. Patients were enrolled after their ulcers had healed and a histological test for Helicobacter pylori was negative. All patients received selecoxib 200 mg daily, and either esomeprazole 20 mg twice daily or placebo. The 13-month cumulative incidence of recurrent ulcer bleeding was 12 cases (8.9%, 95% CI 4.1 to 13.7%) in the controls and 0 (0%) in the combined treatment group (p=0.0004, intention to treat analysis). The combined treatment group included 22 patients (incidence of recurrent ulcer bleeding 0%) and the control group included 21 patients (recurrent ulcer bleeding 19%, 95% CI 2.2 to 35.8) who started concomitant low-dose aspirin.
Comment: The quality of evidence is downgraded by sparse data.
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