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Effectiveness and safety of vonoprazan and amoxicillin dual regimen with Saccharomyces boulardii supplements on eradication of Helicobacter pylori.

  • 2024-11-26
  • BMC gastroenterology 24(1)
    • Jing Yu
    • Chen Cui
    • Kai Ma
    • Peng Yang
    • Yizhou Jiang
    • Xiaoyong Wang

Study Design

Type
Randomized Controlled Trial (RCT)
Sample size
n = 126
Population
Naive H. pylori-infected patients
Methods
Patients were randomly allocated to the ECAB group [20-mg esomeprazole, 500-mg clarithromycin, 1000-mg amoxicillin, and 220-mg bismuth twice/day for 14 days] or the VAS group [20-mg VPZ twice/day, 750-mg amoxicillin three times/day, and 250-mg S. boulardii twice/day for 10 days]
Blinding
Open-label
Duration
14 days for ECAB group, 10 days for VAS group
Funding
Unclear
  • Large Human Trial

Background

Currently, Vonoprazan (VPZ) and amoxicillin dual regimen (VA-dual) has not achieved satisfied efficacy as the first-line treatment for Helicobacter pylori (H. pylori) infection in China. Thus, we aimed to determine the effect of VA-dual plus Saccharomyces boulardii (S. boulardii) on H. pylori eradication rate.

Methods

Naive H. pylori-infected patients were randomly allocated to the ECAB group [20-mg esomeprazole, 500-mg clarithromycin, 1000-mg amoxicillin, and 220-mg bismuth twice/day for 14 days] or the VAS group [20-mg VPZ twice/day, 750-mg amoxicillin three times/day, and 250-mg S. boulardii twice/day for 10 days]. Factors associated with eradication success were explored, and cost-effectiveness analyses were also performed.

Results

Herein, 126 patients were finally included and randomly assigned to the two groups in a 1:1 ratio. The H. pylori eradication rates of VAS and ECAB groups by intention-to-treat analysis were 87.3% and 88.9% (P = 1.000) and by per-protocol analysis were 87.3% and 91.8% (P = 0.560), respectively. The ECAB group had a significantly higher incidence of adverse events than the VAS group. Superior H. pylori eradication in the VAS group was related to small body surface area and being a non-smoker. The cost-effectiveness ratio of the VAS group was less than that of the ECAB group.

Conclusions

Addition of S. boulardii to VA-dual for 10 days is as effective as the 14-days bismuth-based quadruple regimen while ensuring fewer adverse events and lesser cost. This regimen is particularly suitable for low-BSA patients or non-smokers.

Trial registration

Chinese Clinical trial Registry No. ChiCTR2100055101 31/12/2021.

Research Insights

Adverse Events Reported

  • saccharomyces boulardii→Overall tolerability

    The ECAB group had a significantly higher incidence of adverse events than the VAS group.

    Finding
    No significant difference
    Magnitude
    The H. pylori eradication rates of VAS and ECAB groups by intention-to-treat analysis were 87.3% and 88.9% (P = 1.000) and by per-protocol analysis were 87.3% and 91.8% (P = 0.560), respectively. The ECAB group had a significantly higher incidence of adverse events than the VAS group.
    Significant
    Yes
  • saccharomyces boulardii→Overall tolerability

    The VAS group had a significantly lower incidence of adverse events than the ECAB group.

    Finding
    Reported
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