Quadruple therapy compared with dual therapy for eradication of Helicobacter pylori in ulcer patients: results of a randomized prospective single-centre study.

Objective: To assess the efficacy and side-effect profile of two currently advocated treatment regimens for eradicating Helicobacter pylori.

Design: A randomized, controlled, open, single-centre study.

Setting: A community hospital in The Netherlands.

Participants: Seventy-six consecutive patients with (chronic) ulcer disease and biopsy-proven H. pylori infection, but without active ulceration at the time of inclusion.

Interventions: Patients were randomly allocated to 1 week of quadruple therapy with omeprazole, bismuth, tetracycline and metronidazole (group 1) or 2 weeks of dual therapy with omeprazole and amoxicillin (group 2). Group 1 patients were pretreated with omeprazole for 3 days.

Main Outcome Measures: Cure was confirmed by obtaining 10 endoscopic biopsies for urease testing, histology and culture 6 weeks after treatment. Side-effects were scored on a standard questionnaire.

Results: Three patients were lost to follow-up. In the 'intention to treat' analysis 37 (92.5%) of 40 patients in group 1 were cured compared with 20 (55.6%) of 36 patients in group 2 (P < 0.001). The difference in efficacy was 36.9% (95% confidence interval 18.7-55.1%). Side-effects were fewer and milder in group 2, but all patients in both groups were able to complete the course of treatment.

Conclusion: Dual therapy is significantly less effective in curing H. pylori infection in peptic ulcer patients than quadruple therapy. No patients were intolerant to either treatment. On the basis of the low efficacy of dual therapy, we believe that this therapy should not be used as a first-line treatment strategy. We confirmed our previous finding that 1 week of quadruple therapy is tolerated well and that it is highly effective against metronidazole-sensitive as well as metronidazole-resistant strains of H. pylori.