Decreased relapse rate after antibacterial treatment of Helicobacter pylori-associated duodenal ulcers. Munich duodenal ulcer trial

Abstract

Objective: To further elucidate the role of Helicobacter pylori and other factors in duodenal ulcer disease in a randomized, controlled trial. Methods: Two hundred and twenty patients with an active duodenal ulcer and H. pylori colonization were randomly assigned to one of three treatment regimens: ranitidine 300 mg every evening or bismuth subsalicylate (BSS) 600 mg three times daily, or a combination of BSS 600 mg three times daily and 1000 mg amoxicillin twice daily (double therapy). The total duration of therapy was 6 weeks in all groups; amoxicillin was given during the first 10 days. Results: One hundred and seventy-eight patients fulfilled the inclusion criteria and completed therapy. The healing rates were 69% after ranitidine, 77% after BSS and 84% after double therapy. H. pylori was not eradicated in any of the patients receiving ranitidine, in 4% of those on BSS and 52% of those receiving double therapy. Subsequent relapse rates during the 1-year follow-up were 68, 46 and 15%, respectively, and during the 18-month follow-up were 79, 56, and 27%, respectively. Nearly all duodenal ulcer relapses occurred in patients with persistent H. pylori infection. While the overall relapse rate in H. pylori-positive patients was 42% in 12 months, only 4% of the patients in whom H. pylori was eradicated relapsed. In patients who remained H. pylori-positive, the relapse rates correlated significantly with the degree of gastritis at the end of treatment; 28% with grade 2, 47% with grade 3 and 72% with grade 4. Conclusions: The data show that the presence of H. pylori and the grade of gastritis, if it is present, are the most important predictors of duodenal ulcer relapse. Eradication of H. pylori may cure duodenal ulcer disease.