Prospective double-blind trial of duodenal ulcer relapse after eradication of Campylobacter pylori

Abstract

100 consecutive patients with both duodenal ulcer and Campylobacter pylori infection were followed up to see whether eradication of C pylori affected ulcer healing or relapse. Patients were randomly assigned to 8 weeks of treatment with cimetidine or colloidal bismuth subcitrate (CBS), with tinidazole or placebo being given concurrently from days 1 to 10, inclusive. Endoscopy, biopsy, and culture were done at entry, in weeks 10, 22, 34, and 62, and whenever symptoms recurred. There was no maintenance therapy. C pylori persisted in all of the cimetidine-treated patients and in 95% of those treated with cimetidine/tinidazole, but was eradicated in 27% of the CBS/placebo group and 70% of the CBS/tinidazole group. When C pylori persisted, 61% of duodenal ulcers healed and 84% relapsed. When C pylori was cleared 92% of ulcers healed (p less than 0.001) and only 21% relapsed during the 12 month follow-up period (p less than 0.0001).