Objective: This study aimed to evaluate the efficacy and safety of vonoprazan (VPZ) versus proton pump inhibitor (PPI) in clarithromycin-based bismuth-containing quadruple therapy (C-BQT) for the treatment of Helicobacter pylori (H. pylori) eradication. Methods: Medical records of patients in whom H. pylori was eradicated between 1 July 2018 and 31 December 2021 were retrieved retrospectively from the Outpatient Unit of Qilu Hospital. Efficacy, safety, and compliance were compared between VPZ-based and PPI-based C-BQT, containing vonoprazan 20 mg or proton pump inhibitors (lansoprazole 30 mg or esomeprazole 20 mg), bismuth 220 or 200 mg, amoxicillin 1000 mg, and clarithromycin 500 mg, twice daily for 2 weeks by 1:1 propensity score matching analysis. The trial was registed on ClinicalTrials.gov (registration no. NCT05301725).Results: The H. pylori eradication rates of VPZ-based and PPI-based therapies were 88.8% (151/170) and 87.6% (149/170) in the intention-to-treat analysis, 94.1% (144/153) and 91.1% (144/158) in the per-protocol analysis, respectively. The noninferiority of VPZ to PPI was confirmed in all analyses (P < 0.001). The incidence of adverse events was 30.0% (51/170) and 27.1% (46/170) in the VPZ-based and PPIbased groups, respectively. VPZ-based and PPI-based therapies were well tolerated and showed good patient compliance without significant differences.Conclusions: VPZ-based therapy resulted in a satisfactory eradication rate and was well tolerated for H. pylori eradication, which are comparable to PPIs in C-BQT as a first-line treatment for H. pylori infection.

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Background & Aims: Antibiotic resistance of Helicobacter pylori (H. pylori) is increasing worldwide, and bismuth quadruple therapy has been recommended as a first-line regimen in many areas. This study aimed to investigate whether bismuth would improve the eradication rate (ER) of clarithromycin-/metronidazole-/levofloxacinresistant H. pylori strains and how much additional efficacy bismuth could achieve.Methods: PubMed, EMBASE, Web of Science, and Cochrane Central databases for randomized controlled trials were systematically searched by two independent reviewers until 15 January 2022. Pooled ERs of clarithromycin-/metronidazole-/ levofloxacin-resistant H. pylori strains were compared between bismuth-containing and non-bismuth therapies. Pooled risk ratios (RRs) with 95% confidence intervals (CIs) were calculated using a random-effects model. Results:Eight studies enrolling 340 individuals were included. The RRs of pooled ERs compared between bismuth-containing and non-bismuth therapies were 1.83 for clarithromycin-resistant strains (95% CI 1.16-2.89, pooled ER: 76.9% vs. 36.6%, p = .009, I 2 = 0%), 1.39 for metronidazole-resistant strains (95% CI 1.09-1.78, pooled ER: 86.8% vs. 60.9%, p = .008, I 2 = 37%), 2.75 for dual clarithromycin/metronidazoleresistant strains (95% CI 1.01-7.52, pooled ER: 76.9% vs. 18.2%, p = .05, I 2 = 0%), and 1.04 for levofloxacin-resistant strains (95% CI 0.56-1.93, pooled ER: 63.4% vs. 54.3%, p = .90; I 2 = 60%). Bismuth significantly increased the ERs of clarithromycin-, metronidazole-, and dual-resistant strains by 40%, 26%, and 59%, respectively. Subgroup analysis of treatment duration showed that the significantly higher eradication rate for antibiotic-resistant strains in bismuth-containing therapy than non-bismuth therapy was only observed in 14-day treatment regimens and not in 7day regimens (p = .02 and .17, respectively). Conclusions:Bismuth was most effective in improving the ERs of dual-resistant H. pylori strains, followed by clarithromycin-and metronidazole-resistant strains.Prolonged treatment duration might effectively improve the efficacy of bismuth in overcoming antibiotic resistance.