Two-day quadruple therapy for cure of Helicobacter pylori infection: a comparative, randomized trial

Abstract

Objective: We sought to compare a 2-day quadruple therapy with a 14-day triple therapy in the treatment of Helicobacter pylori infection.

Methods: Eighty-one consecutive patients with an endoscopically diagnosed peptic ulcer and demonstrated infection by H. pylori were included in the study. Patients were randomized to receive omeprazole 40 mg b.i.d., amoxicillin 2.5 g once daily, metronidazole 500 mg t.i.d., and bismuth subcitrate 360 mg t.i.d. for 2 days, followed by omeprazole 20 mg once daily for 6 additional days (Group 1) or a 14-day course of omeprazole 20 mg b.i.d., amoxicillin 1 g t.i.d., and metronidazole 500 mg t.i.d. (Group 2). Eradication was evaluated by antral biopsy and rapid urease test at 2 months after therapy and by C13-urea breath test after a year.

Results: Two patients were lost to follow-up at 2 months. Intention-to-treat analysis showed that H. pylori infection was cured in 29 of 42 patients (69%; 95% CI: 53-82%) in Group 1 versus 36 of 39 (92%; 95% CI: 78-98%) of patients in Group 2 (p = 0.009). Per-protocol analysis showed a cure rate of 71% (95% CI: 55-84%) (29/41 patients) and 95% (95% CI: 81-99%) (36/38 patients), respectively (p = 0.007). Fifty-five of 65 cured patients returned 1 year after treatment (26 in Group 1, 29 in Group 2). All but one in Group 2 remained cured. There were no significant differences in compliance (88% in Group 1 versus 92% in Group 2) or in the presence of side effects (27%; 95% CI: 15-43% versus 41%; 95% CI: 26-58%; ns).

Conclusion: Two-day quadruple therapy is significantly less effective than 2-wk triple treatment.