14‐Day Vonoprazan–Minocycline Dual Therapy Versus Bismuth‐Containing Quadruple Therapy for
                    <i>Helicobacter pylori</i>
                    Rescue Treatment: A Single‐Center Randomized Controlled Noninferiority Trial

doi:10.1111/hel.70153

DOI: 10.1111/hel.70153 ISSN: 1083-4389

14‐Day Vonoprazan–Minocycline Dual Therapy Versus Bismuth‐Containing Quadruple Therapy for Helicobacter pylori Rescue Treatment: A Single‐Center Randomized Controlled Noninferiority Trial

Tingting Yang, Ruijuan Xin, Yanhong Deng, Jun Liu, Xue Li, Xiaole Guo, Linke Ma, Xiaoming Su, Yanxia Liu, Chengdong Su, Qian Hao, Rui Mu, Xiaofei Li, Pengda Wang, Yanling Li, Xue Zhang, Qingrui Li, Yuting Wu, Shengjuan Hu

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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 ¹³ C 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, whereas the ITT result should be interpreted cautiously because the lower 95% CI bound crossed the margin. Adverse events were similar between treatment groups (11.8% vs. 15.1%; χ ² = 0.416; p = 0.519), and adherence was high in both groups (97.8% vs. 97.8%; p = 1.000).

Conclusions

14‐day vonoprazan–minocycline dual therapy achieved eradication rates comparable to those of bismuth‐containing quadruple therapy, with acceptable safety and high adherence as rescue treatment for H. pylori infection. This simplified regimen may be considered a potential empirical rescue option when susceptibility testing is not readily available, although the ITT noninferiority result warrants cautious interpretation.