A comparative study of 14‐day dual therapy (esomeprazole and amoxicillin four times daily) and triple plus bismuth therapy for first‐line Helicobacter pylori infection eradication: A randomized trial

Abstract Background Favorable outcomes in treating H pylori infection using “dual therapy (proton pump inhibitor and amoxicillin four times daily)” have attracted widespread attention. However, there are few reports, and the study results lack agreement. This study aimed to compare the eradication rate, safety, and compliance of naïve‐treatment patients with H pylori infection on “dual therapy” with those on “triple plus bismuth (TPB) therapy.” Methods This is a non‐inferior randomized controlled trial conducted on 760 patients with H pylori infection. The participants were randomly assigned to two eradication groups: dual therapy (esomeprazole 20 mg and amoxicillin 750 mg four times daily) and TPB therapy (esomeprazole 20 mg, amoxicillin 1000 mg, clarithromycin 500 mg, and bismuth potassium citrate 220 mg twice daily) for 14 days. Safety and compliance were assessed within 3 days after eradication. Urea breath test was performed about 8 weeks after eradication to evaluate outcome. Antibiotic resistance and CYP2C19 polymorphism were determined. Results Compared with TPB therapy, dual therapy had significantly higher eradication rates in intention‐to‐treat (87.1% vs 80.5%, rate difference 6.6%), modified intention‐to‐treat (90.9% vs 85.5%, 5.5%) and per‐protocol (92.4% vs 87.8%, 4.7%) analyses, respectively. Adverse reactions in dual therapy group were significantly lower than TPB therapy group (17.6% vs 25.5%, P = .008), and dual therapy group had better compliance (96.3% vs 92.3%, P = .019). Antibiotic resistance and poor compliance were also associated with treatment failure. Conclusions Dual therapy (esomeprazole and amoxicillin four times daily) was non‐inferior to, and even superior to TPB therapy as first‐line H pylori eradication.