Triple therapy for 7 days vs. triple therapy for 7 days plus omeprazole for 21 days in treatment of active duodenal ulcer with Helicobacter pylori infection. A double blind placebo controlled trial.

BACKGROUND: The current treatment for active duodenal ulcer implies a 4 weeks course with anti-secretory drugs and two antibiotics for 7 to 10 days in the case of Helicobacter pylori infection. AIM: To establish whether triple therapy with omeprazole given for 7 days with two antibiotics eradicates H. pylori, heals and prevents ulcer recurrence. PATIENTS AND METHODS: A total of 103 patients with active duodenal ulcer and H. pylori were randomly divided into: a group of 50 patients treated with omeprazole, clarithromycin and tinidazole for 7 days followed by omeprazole for 21 days, and a group of 53 patients who received the same treatment as the previous group, followed by placebo for 21 days. Endoscopy with quick urease test, histology and culture was performed at entry and after 4 and 16 weeks.
RESULTS: Ulcer healing rate after 16 weeks' treatment was 95% in the former and 96% in the latter group (ns). Eradication after 16 weeks was 84% in the former and 83% in the latter group (ns). At 56 weeks, all patients examined were ulcer free and without H. pylori.
CONCLUSION: Omeprazole, clarithromycin and tinidazole for 7 days heals active duodenal ulcer and eradicates H. pylori infection in most patients. Treatment extension with omeprazole, for 3 weeks, after triple therapy does not modify healing and eradication rates.

RCT Entities:   Population Interventions Outcomes