Efficacy and safety of neuromodulators combined with proton pump inhibitors for non-erosive reflux disease: A randomized clinical trial

doi:10.3748/wjg.122876

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World Journal of Gastroenterology

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1007-9327

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Baishideng Publishing Group Inc, 7041 Koll Center Parkway, Suite 160, Pleasanton, CA 94566, USA

Randomized Clinical Trial

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): 122876
Published online Nov 28, 2026. doi: 10.3748/wjg.122876

Efficacy and safety of neuromodulators combined with proton pump inhibitors for non-erosive reflux disease: A randomized clinical trial

Ke-Han Yin, Xiao-Yu Wang, Xin-Yuan Wang, Li Cheng, Bo Wang, Qian-Qian Wang, Ying Qiao, Xing-Ru Tang, Xiu-Juan Yan, Sheng-Liang Chen

Ke-Han Yin, Xiao-Yu Wang, Xin-Yuan Wang, Li Cheng, Bo Wang, Qian-Qian Wang, Ying Qiao, Xing-Ru Tang, Xiu-Juan Yan, Sheng-Liang Chen, Division of Gastroenterology and Hepatology, Renji Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai 200001, China

Co-first authors: Ke-Han Yin and Xiao-Yu Wang.

Co-corresponding authors: Xiu-Juan Yan and Sheng-Liang Chen.

Author contributions: Yin KH and Wang XY drafted the manuscript as co-first authors; Yin KH, Wang XY and Wang XY contributed to data acquisition; Cheng L and Wang QQ performed the statistical analysis; Wang B, Qiao Y and Tang XR collected the clinical samples; Yan XJ and Chen SL conducted critical revision on manuscript draft, conceived the study as co-corresponding authors; all authors have reviewed and approved the final 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 National Natural Science Foundation of China, No. 82570628, No. 82170554, and No. 82300643.

Institutional review board statement: The study was reviewed and approved by the Clinical Research Ethics Committee of Renji Hospital, School of Medicine, Shanghai Jiao Tong University, No. LY2025-040-A.

Clinical trial registration statement: The trial is registered at ClinicalTrials.gov, No. NCT06945237.

Informed consent statement: All participants provided informed consent.

Conflict-of-interest statement: All authors declare no conflict of interest in publishing the 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: The data used in this study are available upon reasonable request to the corresponding author.

Corresponding author: Sheng-Liang Chen, MD, PhD, Division of Gastroenterology and Hepatology, Renji Hospital, School of Medicine, Shanghai Jiao Tong University, No. 145 Middle Shandong Road, Shanghai 200001, China. chenslmd@shsmu.edu.cn

Received: May 7, 2026
Revised: June 8, 2026
Accepted: June 29, 2026
Published online: November 28, 2026
Processing time: 147 Days and 12.9 Hours

Core Tip

Core Tip: This randomized, double-blind, placebo-controlled trial evaluated the efficacy, safety and cost-effectiveness of low-dose flupentixol-melitracen combined with lansoprazole as an initial regimen for non-erosive reflux disease. The findings demonstrate that combining short-term, low-dose neuromodulation with a proton pump inhibitor as initial therapy in treatment-naive patients provides rapid, cost-effective symptom relief during the 12-week study period. This early-intervention strategy may help reduce symptom burden and offer a potential alternative to standard proton pump inhibitor monotherapy for patients with non-erosive reflux disease.