Comparison of efficacy and safety between vonoprazan-furazolidone-amoxicillin therapy and quadruple therapy with bismuth for Helicobacter pylori infection

Abstract Background Helicobacter pylori ( H. pylori ) infection is prevalent in China, with a morbidity rate of 44.2%. This infection is closely associated with several gastrointestinal conditions, including chronic gastritis, peptic ulcers, and gastric cancer. Eradicating H. pylori has been shown to decrease the incidence of these diseases. However, in recent years, the rising rate of antibiotic resistance among H. pylori strains has complicated eradication efforts, leading to challenges such as the need for higher doses of antibiotics, increased side effects, and declining success rates. Therefore, there is an urgent need to develop novel, simple, and safe treatments for H. pylori infection. Aim This study aimed to compare the efficacy and safety of a 7-day regimen of vonoprazan, furazolidone, and amoxicillin (triple therapy) with a 14-day bismuth-containing quadruple therapy for the eradication of H. pylori . The findings are intended to provide evidence to support clinical decision-making. Methods A total of 336 patients diagnosed with H. pylori infection via the 13 C-urea breath test were enrolled in this study. They were randomly assigned to either group A (7-day vonoprazan-furazolidone-amoxicillin triple therapy), or group B (14-day bismuth-containing quadruple therapy). Four weeks after completing treatment, the 13 C-urea breath test was conducted to assess the efficacy of eradication. Results In the intention-to-treat (ITT) analysis, the eradication rates were 82.74% (139/168) for the triple therapy group and 77.98% (131/168) for the quadruple therapy group, resulting in a rate difference of 4.76% (95% CI: -3.77% to 13.22%). In the per-protocol (PP) analysis, the eradication rates were 91.45% (139/152) for the triple therapy and 85.62% (131/153) for the quadruple therapy, with a difference of 5.83% (95% CI: -1.42% to 13.14%). The overall incidence of adverse effects was 27.98% in the triple therapy group and 34.52% in the quadruple therapy group, with no statistically significant difference ( P = 0.195). Conclusion The 7-day vonoprazan–furazolidone–amoxicillin triple regimen met the prespecified non-inferiority criterion compared with the 14-day bismuth-containing quadruple regimen for H. pylori eradication in both ITT and PP analyses. The overall incidence of adverse events did not differ significantly between the groups. The shorter treatment duration and simpler regimen may represent practical advantages, although these findings require confirmation in larger multicentre trials.