Copyright: ©Author(s) 2026. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution-NonCommercial (CC BY-NC 4.0) license. No commercial re-use. See permissions. Published by Baishideng Publishing Group Inc.
World J Gastroenterol. Nov 28, 2026; 32(44): 122850
Published online Nov 28, 2026. doi: 10.3748/wjg.122850
Published online Nov 28, 2026. doi: 10.3748/wjg.122850
Add-on trimebutine-maleate does not improve tolerability or eradication in bismuth quadruple therapy for Helicobacter pylori
Eun Jeong Gong, Chang Seok Bang, Department of Internal Medicine, Hallym University College of Medicine, Chuncheon 24253, Gangwon-do, South Korea
Author contributions: Bang CS contributed to conceptualization, formal analysis, funding acquisition, methodology, project administration, resources, and writing-review and editing; Gong EJ and Bang CS contributed to data curation, investigation, writing-original draft.
AI contribution statement: AI was not used for the synthesis of the content of this manuscript.
Supported by the Samil Pharmaceutical Company.
Institutional review board statement: The study protocol was approved by the Institutional Review Board of Chuncheon Sacred Heart Hospital (No. 2020-03-008) and performed in accordance with the Declaration of Helsinki and the Korean Good Clinical Practice guidelines.
Clinical trial registration statement: The trial was prospectively registered at ClinicalTrials.gov (No. NCT04403087).
Informed consent statement: All participants provided written informed consent before any study-related procedure.
Conflict-of-interest statement: Authors attest that there are no commercial associations that might be a conflict of interest in relation to the submitted manuscript.
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: All the data are accessible and available upon request by corresponding author.
Corresponding author: Chang Seok Bang, MD, PhD, Professor, Department of Internal Med
Received: April 30, 2026
Revised: July 13, 2026
Accepted: August 31, 2026
Published online: November 28, 2026
Processing time: 153 Days and 21.3 Hours
Revised: July 13, 2026
Accepted: August 31, 2026
Published online: November 28, 2026
Processing time: 153 Days and 21.3 Hours
Core Tip
Core Tip: This is the first prospective randomized controlled trial to evaluate add-on trimebutine maleate as an adjuvant to 14-day bismuth quadruple therapy for Helicobacter pylori eradication. Despite trimebutine’s widespread off-label use, add-on treatment did not reduce treatment-emergent adverse events, improve medication adherence, or increase eradication rates, with point estimates tightly clustered around the null. Although the trial was underpowered owing to early termination, these findings do not support routine adjunctive use of trimebutine and redirect attention toward mucosa- and microbiota-directed strategies with proven benefit.