Potassium-competitive acid blocker versus proton pump inhibitor as a part of bismuth-based quadruple therapy for treatment of Helicobacter pylori infection: a randomized controlled trial

Abstract Background Helicobacter pylori (H. pylori) eradication regimens require effective acid suppression. Vonoprazan (VPZ), a potassium-competitive acid blocker (P-CAB), provides potent acid suppression and may improve the efficacy of bismuth quadruple therapy (BQT). Purpose of the study To compare the eradication efficacy, safety, treatment adherence, and patient satisfaction of VPZ-based versus proton-pump inhibitor (PPI)-based BQT for H. pylori infection. Methods This prospective, randomized, open-label clinical trial included 320 treatment-naïve patients with confirmed H. pylori infection. Participants were randomly allocated in a 1:1 ratio using a computer-generated randomization sequence, with allocation concealed using opaque, sealed envelopes. Both groups received a 10-day regimen of bismuth, metronidazole, and tetracycline, together with either VPZ 20 mg twice daily or rabeprazole 20 mg twice daily. Eradication was assessed four weeks after treatment, and adverse drug reactions (ADRs), adherence, and patient satisfaction were recorded. Results The H. pylori eradication rate was notably increased in P-CAB cases than in PPI cases (89.38% vs. 75.63%; P = 0.001, 95% confidence interval (CI): 1.07–1.31). ADRs and treatment adherence were comparable between groups. Patient satisfaction was markedly increased in P-CAB cases (P = 0.049). Conclusions P-CAB-based BQT was related with an elevated H. pylori eradication rate and greater patient satisfaction than PPI-based BQT, with comparable ADRs and treatment adherence. These results indicate that P-CAB-based BQT may represent an effective first-line treatment option for H. pylori infection. Trial registration ClinicalTrials.gov (ID NCT07165444).