14-Day Vonoprazan-Minocycline Dual Therapy Versus Bismuth-Containing Quadruple Therapy for Helicobacter pylori Rescue Treatment: A Single-Center Randomized Controlled Noninferiority Trial
Abstract
Background: Rescue treatment for Helicobacter pylori infection remains challenging in regions with high antibiotic resistance. Although bismuth-containing quadruple therapy is widely recommended as an empirical rescue regimen, its medication burden may impair tolerability and adherence. This trial evaluated the efficacy and safety of 14-day vonoprazan-minocycline dual therapy compared with vonoprazan-based bismuth-containing quadruple therapy as empirical rescue treatment.
Materials and methods: This single-center, prospective, open-label, randomized, controlled, noninferiority trial enrolled 186 adults aged 18-70 years with at least one previous H. pylori eradication failure. Patients were randomly assigned (1:1) to receive 14-day vonoprazan-minocycline dual therapy or vonoprazan-, amoxicillin-, minocycline-, and bismuth-containing quadruple therapy. Eradication was assessed by a 13C urea breath test 4 weeks after treatment. ITT, mITT, and PP analyses were performed, with a prespecified noninferiority margin of -10%.
Results: Eradication rates in the dual therapy and quadruple therapy groups were 89.2% and 91.4% in the ITT analysis (difference, -2.2%; 95% CI, -10.5% to 6.2%; noninferiority p = 0.036), 90.2% and 92.4% in the mITT analysis (difference, -2.2%; 95% CI, -9.7% to 5.3%; noninferiority p = 0.030), and 91.2% and 93.4% in the PP analysis (difference, -2.2%; 95% CI, -9.4% to 5.0%; noninferiority p = 0.024). Noninferiority was demonstrated in the mITT and PP analyses,…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 186 participants or records.
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