Esophagus to Small Intestine
Am J Gastroenterol. 2024;119(4):655–61
Ten-day vonoprazan-amoxicillin dual therapy vs. standard 14-day bismuth-based quadruple therapy for first-line Helicobacter pylori eradication: A multicenter randomized clinical trial
Introduction: Whether 10-day short-course vonoprazan-amoxicillin dual therapy (VA-dual) is non-inferior to the standard 14-day bismuth-based quadruple therapy (B-quadruple) against Helicobacter pylori eradication has not been determined. This trial aimed to compare the eradication rate, adverse events, and compliance of 10-day VA-dual regimen with standard 14-day B-quadruple regimen as first-line H. pylori treatment.
Methods: This prospective randomized clinical trial was performed at 3 institutions in eastern China. A total of 314 treatment-naive, H. pylori-infected patients were randomly assigned in a 1:1 ratio to either 10-day VA-dual group or 14-day B-quadruple group. Eradication success was determined by 13C-urea breath test at least 4 weeks after treatment. Eradication rates, adverse events, and compliance were compared between groups.
Results: Eradication rates of VA-dual and B-quadruple groups were 86.0% and 89.2% (p = 0.389), respectively, by intention-to-treat (ITT) analysis; 88.2% and 91.5% (p = 0.338), respectively, by modified ITT analysis; and 90.8% and 91.3% (p = 0.884), respectively, by per-protocol (PP) analysis. The efficacy of the VA-dual therapy remained non-inferior to B-quadruple therapy in all ITT, modified ITT, and PP analyses. The incidence of adverse events in the VA-dual group was significantly lower compared with that in the B-quadruple group (p < 0.001). Poor compliance contributed to eradication failure in the VA-dual group (p < 0.001), while not in the B-quadruple group (p = 0.110).
Discussion: The 10-day vonoprazan-amoxicillin dual therapy provided satisfactory eradication rates of > 90% (per-protocol analysis) and lower rates of adverse events compared with standard 14-day bismuth-based quadruple therapy as first-line Helicobacter pylori therapy.