Duodenal ulcer healing with 1-week eradication triple therapy followed, or not, by anti-secretory treatment: A multicentre double-blind placebo-controlled trial

Abstract

Background: In the management of Helicobacter pylori induced duodenal ulcer, it is still controversial whether anti-secretory treatment needs to be continued following a 1-week course of eradication therapy. Methods: 150 patients with H. pylori active duodenal ulcer (diameter ≥ 5 mm) were included. After a 1-week eradication treatment combining omeprazole 20 mg b.d., amoxicillin 1000 mg b.d. and clarithromycin 500 mg b.d. (OAC), patients were randomized to omeprazole 20 mg or placebo for 3 additional weeks, The primary variable was ulcer healing assessed at 4 weeks. Eradication was verified 4 weeks after cessation of study drugs by 13C-urea breath test. Intention-to-treat analysis (ITT) included 131 patients with positive histopathology at inclusion. Results: Healing rates were not statistically different, at 89% and 87%, respectively, in the OAC-omeprazole and OAC-placebo groups (95% CI: -8.7; 13.7). Numerically, healing rates in patients with successful eradication was higher [94/104 (90%)] than in patients with failed eradication [21/27 (78%)]. However, the difference was not statistically significant (P < 0.1). Conclusions: One-week OAC eradication triple therapy achieves excellent healing rates in patients with uncomplicated duodenal ulcer disease. Although the confidence interval of the difference in healing suggests little or no benefit of continued omeprazole treatment after 1 week, larger studies are needed to address this issue definitively.