Abstract
BACKGROUND: The efficacy of the 14-day esomeprazole-amoxicillin (EA) dual therapy in eradicating Helicobacter pylori (H. pylori) has been widely discussed previously. Vonoprazan, a novel potassium-competitive acid blocker, presents rapid, potent, and long-lasting acid inhibitory effects compared to esomeprazole. However, there is currently a scarcity of direct comparisons between the 10-day vonoprazan-amoxicillin (VA) and the 14-day EA dual therapy for H. pylori eradication. OBJECTIVES: This study aimed to compare the efficacy and safety of the 10-day VA and the 14-day EA dual therapy for H. pylori first-line eradication. DESIGN: This study was a prospective, multicenter, open-label, randomized controlled trial. METHODS: The study was conducted at 10 hospitals in China. In total, 570 newly diagnosed H. pylori-infected patients were recruited from April 2023 to February 2024. These patients were randomly assigned to either the 10-day VA group (vonoprazan 20 mg twice daily + amoxicillin 1000 mg three times daily) or the 14-day EA group (esomeprazole 20 mg four times daily + amoxicillin 750 mg four times daily). The primary outcome was the eradication rate, with secondary outcomes including adverse events and compliance. RESULTS: The 10-day VA regimen outperformed the 14-day EA regimen in terms of eradication rates in intention-to-treat (ITT) analysis (85.4% vs 76.7%, p = 0.008), modified ITT analysis (90.7% vs 84.8%, p = 0.036), and per-protocol (PP) analysis (91.1% versus 85.5%, p = 0.047). The non-inferiority p-values in all three analyses were less than 0.001. No statistically significant difference was observed in the incidence of adverse events between the two groups (9.1% vs 11.7%, p = 0.308). The 10-day VA regimen demonstrated higher compliance compared to the 14-day EA regimen (p = 0.006). CONCLUSION: The 10-day VA dual therapy showed a satisfactory eradication rate of 91.1% (PP analysis), demonstrating good safety and better compliance compared to the 14-day EA dual therapy as the first-line eradication. TRIAL REGISTRATION: This trial was registered in the Chinese Clinical Trial Registry (registration number: ChiCTR2300070475) on April 12, 2023.