Randomized Controlled Trial
Copyright ©The Author(s) 2025. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Gastroenterol. Apr 7, 2025; 31(13): 100863
Published online Apr 7, 2025. doi: 10.3748/wjg.v31.i13.100863
Amoxicillin high-dose dual therapy for Helicobacter pylori primary eradication: Proton pump inhibitor and potassium-competitive acid blocker, which’s better?
Xue-Er Yang, Sheng-Jun Zhang, Yuan Liu, Shuo-Yi Yao, Su-Xin Zhang, Xiao-Ming Liu, Lun-Xi Liang, Fen Wang
Xue-Er Yang, Shuo-Yi Yao, Su-Xin Zhang, Xiao-Ming Liu, Lun-Xi Liang, Fen Wang, Department of Gastroenterology, The Third Xiangya Hospital, Central South University, Changsha 410013, Hunan Province, China
Xue-Er Yang, Shuo-Yi Yao, Su-Xin Zhang, Xiao-Ming Liu, Lun-Xi Liang, Fen Wang, Hunan Key Laboratory of Nonresolving Inflammation and Cancer, The Third Xiangya Hospital, Central South University, Changsha 410006, Hunan Province, China
Sheng-Jun Zhang, Department of Gastroenterology, The Second People's Hospital of Huaihua, Huaihua 418000, Hunan Province, China
Yuan Liu, Department of Gastroenterology, Yueyang Hospital of Traditional Chinese Medicine, Yueyang 414100, Hunan Province, China
Author contributions: Yang XE contributed to investigation, formal analysis, and writing the original draft; Wang F, Zhang SJ, and Liu Y made conceptualization, methodology, writing, reviewing and editing the article, and supervision; Yao SY, Zhang SX, Liu XM, and Liang LX contributed to methodology, formal analysis, and writing, reviewing and editing the article; Wang F is the corresponding author of the article. All authors have read and agreed to the published version of the manuscript.
Supported by the National Natural Science Foundation of China, No. 82270594; the National Natural Science Foundation for Youths of China, No. 82103151; the Outstanding Youth Foundation of Hunan Province, No. 2022JJ20092; and the Wisdom Accumulation and Talent Cultivation Project of Third Xiangya Hospital of Central South University, No. YX202103.
Institutional review board statement: The study protocols received approval from the Ethics Committee of three medical centers (Fast 21292, Fast 23359, HHSEYYEC-202402-K1).
Clinical trial registration statement: A multi-center, prospective, open-label, randomized controlled study was conducted and registered on clinicaltrials.gov with the registration number NCT06250634.
Informed consent statement: All participants voluntarily agreed to participate in this clinical trial and provided written informed consent prior to enrollment.
Conflict-of-interest statement: The authors declare no conflicts of interest.
CONSORT 2010 statement: The authors have read the CONSORT 2010 Statement, and the manuscript was prepared and revised according to the CONSORT 2010 Statement.
Data sharing statement: The data presented in this study are available upon request from the corresponding author.
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: Fen Wang, MD, PhD, Professor, Department of Gastroenterology, The Third Xiangya Hospital, Central South University, No. 138 Tongzipo Road, Changsha 410013, Hunan Province, China. wfen-judy@csu.edu.cn
Received: August 30, 2024
Revised: February 22, 2025
Accepted: March 18, 2025
Published online: April 7, 2025
Processing time: 216 Days and 22.4 Hours
Abstract
BACKGROUND

Effective acid suppression significantly enhances the eradication rate of Helicobacter pylori (H. pylori).

AIM

To assess the efficacy and safety of high-dose dual therapy (HDDT) utilizing various highly potent antisecretory medications, thereby providing additional clinical guidance for H. pylori eradication.

METHODS

The study population comprised untreated H. pylori patients from three medical centers in central China. From February 10, 2024 to March 31, 2024, 439 subjects were randomly allocated to either the esomeprazole-amoxicillin (EA) or esomeprazole-amoxicillin-clarithromycin-bismuth (B-quadruple) group. Subsequently, from April 1, 2024 to May 10, 2024, 367 subjects were randomly assigned to either the vonoprazan-amoxicillin (VA) or vonoprazan-amoxicillin-clarithromycin (VAC) group. The study recorded treatment efficacy, adverse events, compliance, symptom alleviation, and associated costs.

RESULTS

EA-dual demonstrated non-inferiority to B-quadruple regimen in modified intention-to-treat (mITT) and per-protocol (PP) analyses (P < 0.025). However, the eradication rate of EA was lower than that of the B-quadruple group [70.59% vs 83.49%, 92.86% vs 98.38%, 93.94% vs 98.38%, intention-to-treat (ITT), mITT, PP respectively, P < 0.05]. In ITT, mITT, and PP analyses, VA-dual was non-inferior to VAC treatment (84.15% vs 83.15%, 96.25% vs 92.73%, 96.75% vs 93.75%, P < 0.025). No significant differences were observed in adverse events, compliance, and symptom relief between groups. VA exhibited the lowest cost. Antibiotic use within 2 years, poor compliance, and suburban residence were associated with reduced eradication efficacy (P < 0.05).

CONCLUSION

The HDDT based on vonoprazan demonstrated non-inferiority to the VAC triple regimen, suggesting its potential as a recommended first-line treatment for H. pylori eradication. While B-quadruple therapy showed better eradication rate than EA therapy, the latter proved non-inferior in mITT and PP analyses. Notably, antibiotic use within the preceding two years, adherence to treatment protocols, and patient residence emerged as critical factors influencing eradication success.

Keywords: Helicobacter pylori; High-dose dual therapy; Esomeprazole; Vonoprazan; Eradication rate

Core Tip: The global burden of Helicobacter pylori infection is high. Triple and quadruple therapies are both classical regimens. The effect of high-dose dual therapy (HDDT) compared to classical regimens in different regions/populations is unclear. Our study found HDDT based on vonoprazan was non-inferior to the vonoprazan triple regimen. Classical quadruple therapy had a higher eradication rate than HDDT based on esomeprazole, but in modified intention-to-treat and per-protocol analysis, EA therapy was non-inferior to B-quadruple therapy.