Zhu YN, Wang YB, Li L, Ren YD, Wang RR, Ji YL, Wang YP, Zhai HY, Jiang Y. Low-dose vs standard-dose minocycline in bismuth quadruple therapy for first-line Helicobacter pylori eradication: A randomized controlled, noninferiority trial. World J Gastroenterol 2026; 32(36): 122851 [DOI: 10.3748/wjg.122851]
Corresponding Author of This Article
Yong Jiang, MD, Department of Gastroenterology, The Second Hospital of Tianjin Medical University, No. 23 Pingjiang Road, Tianjin 300211, China. jiangyong-612@163.com
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Gastroenterology & Hepatology
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Zhu YN, Wang YB, Li L, Ren YD, Wang RR, Ji YL, Wang YP, Zhai HY, Jiang Y. Low-dose vs standard-dose minocycline in bismuth quadruple therapy for first-line Helicobacter pylori eradication: A randomized controlled, noninferiority trial. World J Gastroenterol 2026; 32(36): 122851 [DOI: 10.3748/wjg.122851]
World J Gastroenterol. Sep 28, 2026; 32(36): 122851 Published online Sep 28, 2026. doi: 10.3748/wjg.122851
Low-dose vs standard-dose minocycline in bismuth quadruple therapy for first-line Helicobacter pylori eradication: A randomized controlled, noninferiority trial
Yong Jiang, Hao-Yu Zhai, Ya-Ping Wang, Ying-Lan Ji, Rao-Rao Wang, Ya-Di Ren, Lu Li, Yong-Bing Wang, Ya-Na Zhu
Ya-Na Zhu, Lu Li, Rao-Rao Wang, Ying-Lan Ji, Ya-Ping Wang, Hao-Yu Zhai, Yong Jiang, Department of Gastroenterology, The Second Hospital of Tianjin Medical University, Tianjin 300211, China
Yong-Bing Wang, Department of Gastroenterology, Yunyang People's Hospital, Chongqing 404500, China
Ya-Di Ren, Department of Gastroenterology, Handan Central Hospital, Handan 056000, Hebei Province China
Co-first authors: Ya-Na Zhu and Yong-Bing Wang.
Co-corresponding authors: Hao-Yu Zhai and Yong Jiang.
Author contributions: Zhu YN and Wang YB contribute equally to this study as co-first authors; Jiang Y and Zhai HY contribute equally to this study as co-corresponding authors; Zhu YN designed the study and write the manuscript; Wang YB conceived the study, performed the statistical analysis, and critically revised the manuscript; Li L, Ren YD, Wang RR, Ji YL, and Wang YP collected the data and performed statistical analysis; Li L, Jiang Y, and Zhai HY supported editing of the original draft and critically revised the manuscript.
AI contribution statement: Portions of this manuscript were edited using AI tools solely for language refinement. The authors carefully reviewed and verified all AI-assisted outputs and take full responsibility for the scientific content of the manuscript.
Supported by Tianjin Municipal Education Commission Scientific Research Program, No. 2023KJ025.
Institutional review board statement: This study was approved by the Ethics Committee of The Second Hospital of Tianjin Medical University, No. KY2024K340.
Clinical trial registration statement: The trial was registered at the Chinese Clinical Trial Registry (www.chictr.org.cn), No. ChiCTR2500100094.
Informed consent statement: All participants provided written informed consent prior to enrollment in the study.
Conflict-of-interest statement: The authors declare that they have no conflict 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: Deidentified individual participant data and study materials are available from the corresponding author upon reasonable request for academic purposes.
Corresponding author: Yong Jiang, MD, Department of Gastroenterology, The Second Hospital of Tianjin Medical University, No. 23 Pingjiang Road, Tianjin 300211, China. jiangyong-612@163.com
Received: April 30, 2026 Revised: June 23, 2026 Accepted: July 6, 2026 Published online: September 28, 2026 Processing time: 114 Days and 7.7 Hours
Abstract
BACKGROUND
Bismuth-containing quadruple therapy (BQT) is a proven first-line therapy against Helicobacter pylori (H. pylori) infection. Minocycline has been progressively employed as a possible alternative in clinical practice to tetracycline; nevertheless, the optimum dosing of minocycline in BQT is not well understood.
AIM
To compare the noninferiority of a low dose (50 mg) minocycline-based BQT with the standard dose (100 mg) regimen in treatment-naive patients.
METHODS
This was a noninferiority, prospective, randomized, controlled trial that recruited treatment-naive Chinese patients suffering from H. pylori infection. Moreover, the participants were randomly allocated (1:1) to either a low-dose experimental regimen (rabeprazole sodium enteric-coated capsules 20 mg, compound bismuth aluminate granules 2.6 g, amoxicillin 1000 mg, and minocycline 50 mg, all at a dose of 2 times a day) or a standard-dose control regimen (the same components except minocycline 100 mg, 2 times a day). A standardized mucosal healing period was then administered to patients with concomitant peptic ulcers. The main outcome measure was the eradication rate of H. pylori, which was measured by the 13C-urea breath test. Secondary endpoints included incidence of treatment compliance, adverse events (AEs), peptic ulcer healing rate, and cost-effectiveness.
RESULTS
The intention-to-treat analysis indicated that the H. pylori eradication rates were 84.2% and 87.5% in the low-dose and standard-dose groups (risk difference: -3.3%; 95%CI: -10.7% to 4.1%; P = 0.459). The per-protocol (PP) analysis yielded consistent results (91.0% vs 92.9%; risk difference: -1.9%; 95%CI: -7.9% to 4.1%; P = 0.595). The PP analysis showed that the low-dose regimen was not inferior (P = 0.013). It is important to note that the low-dose group had a much better safety profile, and the AEs were less frequent (18.3% vs 32.5%; P = 0.012). No substantial variances were noted in treatment compliance (98.3% vs 97.5%; P = 1.000) or ulcer healing rate (88.0% vs 85.2%; P = 1.000). The cost-effectiveness ratio was less in the low-dose group (3.54 vs 4.34).
CONCLUSION
BQT using low doses of minocycline has high eradication efficacy of H. pylori with fewer AEs and better cost-effectiveness, which justifies its expanded clinical application.
Core Tip: The optimal dose of minocycline in bismuth-containing quadruple therapy remains uncertain. This study demonstrates that a low-dose minocycline-based regimen is noninferior to the standard-dose regimen in treatment-naïve Helicobacter pylori infection, while offering a superior safety profile and better cost-effectiveness, supporting its clinical utility.
