One‐week low‐dose triple therapy for Helicobacter pylori is sufficient for relief from symptoms and healing of duodenal ulcers

Aim: To test the hypothesis that 1‐week low‐dose triple therapy for H. pylori is sufficient for relief from dyspeptic symptoms and healing of duodenal ulcers. Methods: Fifty‐nine out‐patients with duodenal ulcers and positive rapid urease test participated in this randomized, double‐blind, two‐centre study. All patients were treated for 1 week with omeprazole 20 mg b.d., clarithromycin 250 mg b.d. and metronidazole 400 mg b.d. In a double‐blind fashion, patients were then randomly treated for another 3 weeks with either omeprazole 20 mg once daily or an identical‐looking placebo. Patients were investigated endoscopically before treatment for H. pylori, after 2 weeks and after 4 weeks. H. pylori infection was assessed by a 13C‐urea breath test at the time of enrolment and 4 weeks after cessation of any study medication. Results: Fifty‐two patients were included in the ‘all patients treated’ analysis of efficacy. The overall H. pylori cure rate was 96% (95% CI=87–100%), with no difference between the treatment groups. After 2 weeks duodenal ulcer healing was confirmed in 91% (95% CI=80–100%) of patients treated with omeprazole and in 76% (95% CI=60–91%) in the placebo group (P=0.14). After 4 weeks all ulcers had healed. Relief from dyspeptic symptoms and adverse events (13.8 and 16.7%) did not differ between the treatment groups. Conclusions: One‐week low‐dose triple therapy consisting of omeprazole, clarithromycin and metronidazole is a highly effective and well‐tolerated approach to the cure of H. pylori infection in patients with a duodenal ulcer. Our data suggest that continuation of antisecretory drug therapy beyond anti‐H. pylori therapy is actually excessive regarding relief from dyspeptic symptoms and healing of duodenal ulcers.