Triple therapy in the eradication of Helicobacter pylori in patients with duodenal ulcer disease: results of a multicentre study in South-East Asia

Background: The efficacy of proton pump inhibitor based triple therapy in p atients from South-East Asia, where metronidazole resistance is reportedly high, has not been formally assessed in randomized, multicentre trials. Aim: To compare the eradication rates of Helicobacter pylori, ulcer healing rates and side-effects of three regimens of omeprazole triple therapy in p atients with duodenal ulcer from South-East Asia and to study the impact of metronidazole resistance. Methods: A single blind, randomized parallel group, comparative multicentre study. A total of 246 patients from 15 centres in four South-East Asian co untries were randomized to receive OAC (omeprazole 20 mg b.d., amoxycillin 1 g b.d., clarithromycin 500 mg b.d.), OAM (omeprazole 20 mg b.d., amoxycil lin 1 g b.d., metronidazole 400 mg b.d.) or OMC (omeprazole 20 mg b.d., met ronidazole 400 mg b.d., clarithromycin 500 mg b.d.) for 7 days. After tripl e therapy, the patients were further randomized to receive either omeprazol e or placebo for 7 days. Upper gastrointestinal endoscopy was performed bef ore treatment and 4 weeks after treatment. Biopsies for culture and for his topathological examination for H. pylori were taken from corpus and antrum before treatment and 4 weeks after treatment. Results: The eradication rates were intention-to-treat/per protocol (95% CI ): OAC 87% (79-94%)/94% (89-100%); OAM 80% (70-89%)/91% (83-98%); OMC 85% ( 77-93%)/94% (88-100%). The difference in eradication rates between the thre e groups was not statistically significant (P=0.419). Pre-treatment metroni dazole resistance, was found in 34% of isolates and was a significant progn ostic factor in patients receiving OAM (odds ratio 5.26) but not in patient s receiving OAC or OMC. Conclusions: All three treatment regimens were safe, well tolerated and hig hly effective for eradication of H. pylori and ulcer healing. Pre-treatment metronidazole resistance reduced the efficacy of OAM but did not affect th e efficacy of OMC.