| Objective To compare the efficacy, incidence of adverse reactions, and treatment compliance of vonoprazan-dual therapy with vonoprazan-triple therapy containing clarithromycin for the treatment-naive Helicobacter pylori infection. Methods A single-centre randomized controlled trial was conducted in the Outpatients from Gastroenterology Department at the University of Hong Kong-Shenzhen Hospital from March 2022 to August 2023. A total of 198 patients were randomly assigned to the vonoprazan-dual grou(n=100) or vonoprazan-triple group(n=98) by a random number table. The Helicobacter pylori eradication rate, incidence of adverse reactions, and good treatment compliance were compared between the two groups after follow-up． Results Intention-to-treat (ITT) analysis showed that compared with the vonoprazan triple therapy group, the vonoprazan dual therapy group had a higher Helicobacter pylori eradication rate (96.0%vs95.9%), the non-inferiority test showed that it met the prespecified non-inferiority standard (P<0.025). Modified ITT (MITT) analysis showed that compared with the vonoprazan triple therapy group, the vonoprazan dual therapy group had a higher Helicobacter pylori eradication rate (97.0%vs96.9%), the non-inferiority test showed that it met the prespecified non-inferiority standard (P<0.025). Per-protocol (PP) analysis showed that compared with the vonoprazan triple therapy group, the vonoprazan dual therapy group did not have a lower eradication rate (96.7%vs96.7%), the non-inferiority test showed that it met the prespecified non-inferiority standard (P<0.025). Compared with the vonoprazan triple therapy group, the vonoprazan dual therapy group had a lower incidence of adverse reactions (39.0%vs56.1%), and the difference was statistically significant (P<0.05). Compared with the vonoprazan triple therapy group, the vonoprazan dual therapy group had a lower good treatment compliance (95.0%vs95.9%), and the difference was not statistically significant (P>0.05). Conclusion For treatment-naive patients with Helicobacter pylori infection, vonoprazan-dual therapy demonstrated non-inferior eradication rate compared with vonoprazan-triple therapy, with a lower rate of adverse reaction and reduced antibiotic use. Therefore, vonoprazan-dual therapy is more recommended as the first-line treatment for treatment-naive patients. |
