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Comparison of vonoprazan-based with rabeprazole-based dual therapy for treatment-naive patients of Helicobacter pylori infection: a prospective, multi-center, randomized controlled study

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Abstract

Background

The application of vonoprazan significantly improved the eradication rate of Helicobacter pylori (H. pylori). This study aimed to compare efficacy and safety of the 10-day vonoprazan–amoxicillin (VA) and 14-day rabeprazole–amoxicillin (RA) dual therapy, and to provide a more efficient, safer, and convenient dual regimen for H. pylori infection.

Methods

This was a prospective, open-label, multi-center, randomized controlled study of treatment-naive patients with H. pylori infection. The participants were randomly assigned to the 10-day VA group with vonoprazan 20 mg Bid plus amoxicillin 1 g Tid or the 14-day RA group with rabeprazole 10 mg Tid plus amoxicillin 1 g Tid. The effectiveness, the adverse events, and the patient compliance of the two groups were compared.

Results

A total of 690 patients were enrolled. The eradication rates of 10-day VA and 14-day RA dual therapy were 89.3% and 84.9% in intention-to-treat (ITT) analysis (P = 0.088); 90.6% and 85.9% by modified intention-to-treat (mITT) analysis (P = 0.059); 91.4% and 86.6% by per-protocol (PP) analysis (P = 0.047). Non-inferiority was confirmed between the two groups (all P < 0.001). No discernible differences were observed in adverse effects and compliance between groups. Poor compliance reduced the eradication efficacy (P < 0.05).

Conclusions

The 10-day VA dual therapy was non-inferior to the 14-day RA dual therapy for H. pylori treatment-naive patients, which should be given priority in the first-line treatment. The application of vonoprazan reduced treatment course and antibiotic use. Patients’ adherence was crucial for the success of eradication.

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Acknowledgements

We wish to express our sincere gratitude to Drs. Guo-Yu Chen, Zi-Xian Yang, De-Min Li, Fang Xiao, Ai-Xiang Wang, Li Cao, Hua-Ping Xie, Ling-Li Xu, Qi Zhou, Yan Yu, Xiao-Jun Xu, Hong Zhang, Xuan-Xuan Li, Xian Xu, Jing Wang, Qin Yu, Chao-Qun Huang, Huai Xu, Rui Zhu, and Fen Wang for their tireless dedication in recruiting patients. We greatly appreciate the help of Ying Zhuang and Bi-Yu He for their selfless and hard-working follow-up.

Funding

This study was supported by the Hainan Provincial Natural Science Foundation of China (823QN372 and 821RC736); Hainan Province Science and Technology Special Fund (ZDYF2022SHFZ057).

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Author notes

  1. Ying-Ying Han and Lin Zhou contributed equally to this work.

Authors and Affiliations

  1. Department of Gastroenterology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, 1095 Jiefang Avenue, Wuhan, 430030, China

    Ying-Ying Han & Pei-Yuan Li

  2. Department of Gastroenterology, Suizhou Central Hospital, Suizhou, China

    Lin Zhou & Shuang-Ling Li

  3. Department of Gastroenterology, Hubei Provincial Hospital of Traditional Chinese Medicine, Wuhan, China

    Yun-Lian Hu & Cheng-Xia Su

  4. Department of Gastroenterology, Wuhan Fourth Hospital, Wuhan, China

    Xiang-Wu Ding & Yan Chen

  5. Department of Gastroenterology, Tianyou Hospital Affiliated to Wuhan University of Science and Technology, Wuhan, China

    Hui Long & Jie Chen

  6. Department of Gastroenterology, Shanghai East Hospital, Tongji University School of Medicine, Shanghai, China

    Fei Liu

  7. Department of Gastroenterology, Shanghai Pudong New Area People’s Hospital, Shanghai, China

    Ming Xu

  8. Department of Gastroenterology, Nanjing First Hospital, Nanjing Medical University, Nanjing, China

    Zhen-Yu Zhang

  9. Department of Gastroenterology, Wenchang People’s Hospital, 42 Wenqing Avenue, Wenchang, 571321, China

    Qiu-Yan Wang, Ya Lin & Pei-Yuan Li

Authors
  1. Ying-Ying Han
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Contributions

Study design: Y-YH, P-YL; patient recruitment and acquisition of data: YL, LZ, Y-LH, X-WD, HL, FL, G-YC, Z-YZ, S-LL, Q-YW, C-XS, YC, JC; data interpretation, statistical analysis, and manuscript editing: Y-YH, P-YL. All authors reviewed the manuscript and approved the final version of this report.

Corresponding authors

Correspondence to Ya Lin or Pei-Yuan Li.

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Conflict of interest

All authors declare no conflicts of interest.

Ethics approval statement

The study protocol was approved by the Institutional Ethics Board of Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.

Clinical trial registration

The trial was registered in the Chinese Clinical Trials Registration (chictr.org.cn: ChiCTR2200059309).

Patient consent statement

All patients agreed to participate in this study and gave informed consent.

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Han, YY., Zhou, L., Hu, YL. et al. Comparison of vonoprazan-based with rabeprazole-based dual therapy for treatment-naive patients of Helicobacter pylori infection: a prospective, multi-center, randomized controlled study. J Gastroenterol 58, 1167–1177 (2023). https://doi.org/10.1007/s00535-023-02042-2

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