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

Am J Gastroenterol. 2024 Apr 1;119(4):655-661. doi: 10.14309/ajg.0000000000002592. Epub 2023 Nov 17.


Introduction: Whether 10-day short-course vonoprazan-amoxicillin dual therapy (VA-dual) is noninferior 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 13 C-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 remained noninferior 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 VA-dual therapy provided satisfactory eradication rates of >90% (PP analysis) and lower rates of adverse events compared with standard 14-day B-quadruple therapy as first-line H. pylori therapy.

Trail registration number: ChiCTR2300070100.

Publication types

  • Randomized Controlled Trial
  • Multicenter Study

MeSH terms

  • Amoxicillin / therapeutic use
  • Anti-Bacterial Agents
  • Bismuth / adverse effects
  • Bismuth / therapeutic use
  • Drug Therapy, Combination
  • Helicobacter Infections* / drug therapy
  • Helicobacter pylori*
  • Humans
  • Medication Adherence
  • Prospective Studies
  • Proton Pump Inhibitors / adverse effects
  • Pyrroles*
  • Sulfonamides*
  • Treatment Outcome


  • Amoxicillin
  • Bismuth
  • Anti-Bacterial Agents
  • 1-(5-(2-fluorophenyl)-1-(pyridin-3-ylsulfonyl)-1H-pyrrol-3-yl)-N-methylmethanamine
  • Proton Pump Inhibitors
  • Pyrroles
  • Sulfonamides