QUADRUPLE THERAPY COMPARED WITH DUAL THERAPY FOR ERADICATION OF HELICOBACTER-PYLORI IN ULCER PATIENTS - RESULTS OF A RANDOMIZED PROSPECTIVESINGLE-CENTER STUDY

Objective: To assess the efficacy and side-effect profile of two curre ntly 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 co nsecutive patients with (chronic) ulcer disease and biopsy-proven H. p ylori infection, but without active ulceration at the time of inclusio n. Interventions: Patients were randomly allocated to 1 week of quadru ple therapy with omeprazole, bismuth, tetracycline and metronidazole ( group 1) or 2 weeks of dual therapy with omeprazole and amoxicillin (g roup 2). Group 1 patients were pretreated with omeprazole for 3 days. Main outcome measures: Cure was confirmed by obtaining 10 endoscopic b iopsies for urease testing, histology and culture 6 weeks after treatm ent. Side-effects were scored on a standard questionnaire. Results: Th ree patients were lost to follow-up. In the 'intention to treat' analy sis 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 few er and milder in group 2, but all patients in both groups were able to complete the course of treatment. Conclusion: Dual therapy is signifi cantly less effective in curing H. pylori infection in peptic ulcer pa tients than quadruple therapy. No patients were intolerant to either t reatment. On the basis of the low efficacy of dual therapy, we believe that this therapy should not be used as a first-line treatment strate gy. We confirmed our previous finding that 1 week of quadruple therapy is tolerated well and that it is highly effective against metronidazo le-sensitive as well as metronidazole-resistant strains of H. pylori.