Dual therapy vs bismuth quadruple therapy in recurrent H. pylori: multicenter randomized trial

Abstract

With increasing antibiotic resistance, treatment of H. pylori infection has gradually become a challenge for clinicians. Objectives: To compare the efficacy and safety of dual therapy plus bismuth (DTB) with quadruple therapy with bismuth (DBT) for the treatment of H. pylori in patients with at least one previous eradication therapy failure. The primary objective was eradication of H. pylori at 6 weeks after treatment. Materials and methods: Randomized, open-label, superiority clinical trial evaluating H. pylori eradication in patients with at least one prior treatment failure. Participants were randomly assigned to receive a 14-day course of bismuth-based dual therapy (TDB: esomeprazole 40mg three times daily, amoxicillin 1g three times daily, and bismuth subsalicylate 262mg four times daily) or bismuth-based quadruple therapy (TQB: esomeprazole 40mg three times daily, amoxicillin 1g three times daily, doxycycline 100mg twice daily, and bismuth subsalicylate 262mg four times daily). Results: A total of 267 of 283 subjects were randomized; 11 were excluded due to exclusion criteria and 5 declined participations. Eradication rates by intention-to-treat and per-protocol analyses were 90.1% (119/131; 95% CI: 84.7-94.7%) and 95.8% (113/118; 95% CI: 90.5-98.2%) for TDB, and 78.7% (107/136; 95% CI: 71.1-84.7%) and 84.7% (94/111; 95% CI: 76.8-90.2%) for TQB. Superiority of TDB was confirmed (p=0.001 in ITT; p=0.04 in PP). Adverse events occurred in 30.5% (33/131) of TDB patients and 44.1% (60/136) of TQB patients (p=0.001). Conclusions: Bismuth-based dual therapy is a superior alternative to classical bismuth quadruple therapy for the treatment of patients with at least one failed therapy for H. pylori, as it provides greater eradication with superior safety and compliance.