BackgroundThe eradication rate of Helicobacter pylori (H. pylori) decreased gradually. This study aimed to analyze the e cacy and safety of a 14-day combination of vonoprazan and amoxicillin as the rst-line eradication therapy for H. pylori infection, and compared them with those of the bismuth quadruple therapy.
MethodsA prospective randomized clinical trial (RCT) was designed, involving patients with H. pylori infection in 6 institutions who did not receive any treatment yet. They were randomly assigned into VA-dual group (vonprazan 20mg b.i.d + amoxicillin 750mg q.i.d) or EACP-quadruple group (esomeprazole 20mg + amoxicillin 1000mg + clarithromycin 500mg + colloidal bismuth subcitrate 220mg b.i.d) for 14 days in ratio of 1:1. At least 28 days later, the eradication rate were detected by the 13 C-urea breath test (UBT).
ResultsA total of 562 patients from February 2022 to September 2022 were enrolled and 316 were randomly. In the ITT analysis, the eradication rates of H. pylori in VA-dual group and EACP-quadruple group were 89.9% and 81.0% respectively, p = 0.037. In the PP analysis were 97.9% and 90.8%, p = 0.009. The different eradication rate was 8.9% (95%CI, 1.2-16.5%) and 7.2% (95%CI, 1.8-12.4%) in ITT and PP analysis, both lower limit of the 95%CI was still higher than the prespeci ed margin. In addition, the incidence of adverse events in VA-dual group was signi cantly lower than that in EACP-quadruple group (19.0% vs. 43.0%, P < 0.001).
ConclusionThe e cacy and safety of a 14-day combination therapy of vonoprazan and amoxicillin in eradicating H. pylori are superior to bismuth quadruple therapy, and this combination signi cantly reduces the use of antibiotics.