Clinical Trials Study
Copyright ©The Author(s) 2024. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Gastroenterol. Jul 21, 2024; 30(27): 3304-3313
Published online Jul 21, 2024. doi: 10.3748/wjg.v30.i27.3304
Vonoprazan-amoxicillin dual therapy for Helicobacter pylori eradication in Chinese population: A prospective, multicenter, randomized, two-stage study
Xue-Ping Huang, Yi-Juan Liu, Shao-Wei Lin, Yan-Feng Shao, Feng Qiu, Qing-Wu Qiu, Zhang-Kun Xu, Jin-Xian Chen, Liang-Huo Chen, Zhen-Qun Lin, Wen-Hua Dai, Ming-Qing Zhang, Qi Jiang, Zhong-Qin Xiao, Xian-Xing Cheng, Xiang-Fei Zhang, Wen-Bin You, Wei Chen, Long-Qin Li, Wei-Xing Lin, Yong-Fu Wang, Fu-Jin Lai, Long-Qun Chen, Zhong-Hua Huang, Wen-Qi Zheng, Jin-Qi Wei, Zhi-Hui Lin
Xue-Ping Huang, Zhi-Hui Lin, Department of Gastroenterology, Shengli Clinical Medical College of Fujian Medical University, Fuzhou 350000, Fujian Province, China
Xue-Ping Huang, Zhi-Hui Lin, Department of Gastroenterology, Fujian Provincial Hospital, Fuzhou 350001, Fujian Province, China
Yi-Juan Liu, Department of Gastroenterology, The First Affiliated Hospital of Fujian Medical University, Fuzhou 350000, Fujian Province, China
Shao-Wei Lin, School of Public Health, Fujian Medical University, Fuzhou 350000, Fujian Province, China
Yan-Feng Shao, Department of Gastroenterology, The Third People’s Hospital of Fujian Province, Fuzhou 350000, Fujian Province, China
Feng Qiu, Department of Gastroenterology, Fujian Provincial Hospital North Brance Fujian Provincial Geriatric Hospital, Fuzhou 350000, Fujian Province, China
Qing-Wu Qiu, Department of Gastroenterology, Xiaoao Hospital, Fuzhou 350000, Fujian Province, China
Zhang-Kun Xu, Department of Gastroenterology, The General Hospital of Fujian Energy Group, Fuzhou 350000, Fujian Province, China
Jin-Xian Chen, Department of Gastroenterology, The Second Hospital of Zhangzhou, Zhangzhou 363000, Fujian Province, China
Liang-Huo Chen, Department of Gastroenterology, Anxi Country Hospital, Quanzhou 362000, Fujian Province, China
Zhen-Qun Lin, Department of Gastroenterology, Zhangzhou Municipal Hospital of TCM, Zhangzhou 363000, Fujian Province, China
Wen-Hua Dai, Department of Gastroenterology, Zhangpu Hospital, Zhangzhou 363000, Fujian Province, China
Ming-Qing Zhang, Department of Gastroenterology, The Affiliated Dongnan Hospital of Xiamen University, Zhangzhou 363000, Fujian Province, China
Qi Jiang, Department of Gastroenterology, First Hospital of Nanping City, Nanping 353000, Fujian Province, China
Zhong-Qin Xiao, Department of Gastroenterology, Fujian Nanping Second Hospital, Nanping 353000, Fujian Province, China
Xian-Xing Cheng, Department of Gastroenterology, Wuyishan Municipal Hospital, Nanping 353000, Fujian Province, China
Xiang-Fei Zhang, Department of Gastroenterology, Fuzhou Changle District Hospital, Fuzhou 350000, Fujian Province, China
Wen-Bin You, Wei Chen, Department of Gastroenterology, Changle City Second Hospital, Fuzhou 350000, Fujian Province, China
Long-Qin Li, Department of Gastroenterology, Jinjiang Municipal Hospital, Quanzhou 362000, Fujian Province, China
Wei-Xing Lin, Department of Gastroenterology, Fuding Hospital Affiliated to Fujian University of Traditional Chinese Medicine, Ningde 352000, Fujian Province, China
Yong-Fu Wang, Department of Gastroenterology, Liancheng Hospital, Longyan 364000, Fujian Province, China
Fu-Jin Lai, Department of Gastroenterology, Xiapu County Hospital, Ningde 352000, Fujian Province, China
Long-Qun Chen, Department of Gastroenterology, Jinjiang Second Hospital, Quanzhou 362000, Fujian Province, China
Zhong-Hua Huang, Department of Gastroenterology, The First Hospital of Putian City, Putian 351100, Fujian Province, China
Wen-Qi Zheng, Department of Gastroenterology, Putian Fude Hospital, Putian 351100, Fujian Province, China
Jin-Qi Wei, Department of Gastroenterology, The 5th Affiliated Hospital of Sun Yat-sen University, Zhuhai 519000, Guangdong Province, China
Co-first authors: Xue-Ping Huang and Yi-Juan Liu.
Co-corresponding authors: Jin-Qi Wei and Zhi-Hui Lin.
Author contributions: Lin ZH and Wei JQ should be considered co-corresponding authors because of their significant contributions throughout the research; Lin ZH and Wei JQ conceived, designed, and supervised the study; Huang XP and Liu YJ contributed equally to the study; Huang XP and Liu YJ designed and performed the experiments, analyzed the data, prepared figures and tables, and authored and reviewed drafts of the article; Lin SW, Shao YF, Qiu F, Qiu QW, Xu ZK, Chen JX, Chen LH, Lin ZQ, Dai WH, Zhang MQ, Jiang Q, Xiao ZQ, Cheng XX, Zhang XF, You WB, Chen W, Li LQ, Lin WX, Wang YF, Lai FJ, Chen LQ, Huang ZH, and Zheng WQ collected and analyzed the data; and all authors have read and approved the final manuscript.
Supported by the Natural Science Foundation of Fujian Province, No. 2020J011087 and No. 2022J011025; Medical Innovation Project of Fujian Provincial Health Commission, No. 2020CXA006; and Zhuhai Science and Technology Project, No. 20181117E030040.
Institutional review board statement: The study was reviewed and approved by the Medical Ethics Committee of Fujian Provincial Hospital Institutional Review Board (Approval No. K2021-006-02).
Clinical trial registration statement: This study is registered at https://www.chictr.org.cn/showprojEN.html?proj=121897. The registration identification number is ChiCTR2100045778.
Informed consent statement: All study participants or their legal guardians provided informed written consent prior to study enrollment.
Conflict-of-interest statement: The authors declare that they have no conflict of interest to disclose.
Data sharing statement: The data that support the findings of this study are available from the corresponding author upon reasonable request.
CONSORT 2010 statement: The authors have read the CONSORT 2010 statement, and the manuscript was prepared and revised according to the CONSORT 2010 statement.
Open-Access: This article is an open-access article that was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution NonCommercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: https://creativecommons.org/Licenses/by-nc/4.0/
Corresponding author: Zhi-Hui Lin, MD, PhD, Chief Doctor, Department of Gastroenterology, Shengli Clinical Medical College of Fujian Medical University, No. 134 Dongjie, Gulou District, Fuzhou 350000, Fujian Province, China. fjslyylzh@fjmu.edu.cn
Received: March 22, 2024
Revised: June 12, 2024
Accepted: June 25, 2024
Published online: July 21, 2024
Processing time: 111 Days and 3.5 Hours
Abstract
BACKGROUND

The efficacy of Vonoprazan-amoxicillin dual therapy (VAT) in the treatment of Helicobacter pylori (H. pylori) is controversial.

AIM

To evaluate the efficacy of VAT in the Chinese population.

METHODS

This prospective, multicenter, randomized, open-label, and two-stage study was conducted at 23 centers in Fujian, China (May 2021-April 2022). H. pylori-infected patients were randomized to bismuth quadruple therapy (BQT), BQT-Vonoprazan (BQT-V), seven-day VAT (VAT-7), ten-day VAT (VAT-10), and fourteen-day VAT (VAT-14) groups. The primary endpoint was the H. pylori eradication rate. The secondary endpoint was the frequency of adverse events. This study was registered with the Chinese Clinical Trial Registry, ChiCTR2100045778.

RESULTS

In the first stage, VAT-7 and BQT-V groups were selected for early termination because less than 23 among 28 cases were eradicated. In the second stage, the eradication rates for BQT, VAT-10, and VA-14 were 80.2% [95% confidence interval (95%CI): 71.4%-86.8%], 93.2% (86.6%-96.7%), 92.2% (85.3%-96.0%) in the intention-to-treat (ITT) analysis, and 80.9% (95%CI: 71.7%-87.5%), 94.0% (87.5%-97.2%), and 93.9% (87.4%-97.2%) in the per-protocol analysis. The ITT analysis showed a higher eradication rate in the VAT-10 and VAT-14 groups than in the BQT group (P = 0.022 and P = 0.046, respectively). The incidence of adverse events in the VAT-10 and VAT-14 groups was lower than in the BQT group (25.27% and 13.73% vs 37.62%, respectively; P < 0.001).

CONCLUSION

VAT with a duration of 10 or 14 days achieves a higher eradication rate than the BQT, with a more tolerable safety profile in H. pylori-infected patients in Fujian.

Keywords: Helicobacter pylori, Vonoprazan, Amoxicillin, Dual therapy, Bismuth quadruple therapy

Core Tip: Our study was a prospective, multicenter, randomized, two-stage study for Helicobacter pylori (H. pylori) eradication in Chinese population. We found that a daily dose of 20 mg of Vonoprazan was sufficient to eradicate H. pylori. We also found that compared to bismuth quadruple therapy, Vonoprazan-amoxicillin dual therapy with a duration of 10 days or 14 days, rather than 7 days, achieved higher eradication rates and that the safety profile of this dual therapy was more tolerable and manageable in Chinese patients. These results will guide further research and clinical practice for H. pylori eradication.