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 ʼintention to treatʼ analysis 37 (92.5%) of 40 patients in group 1 were cured compared with 20 (55.6%) of 36 patients in group 2 (P