Clinical Trials Study
Copyright ©The Author(s) 2021. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Gastroenterol. Jul 28, 2021; 27(28): 4710-4721
Published online Jul 28, 2021. doi: 10.3748/wjg.v27.i28.4710
Modified Xiaochaihu Decoction for gastroesophageal reflux disease: A randomized double-simulation controlled trial
Zhe Li, Lin Tao, Sheng-Sheng Zhang, Xiao-Hong Sun, Su-Ning Chen, Jing Wu
Zhe Li, Lin Tao, Sheng-Sheng Zhang, The Digestive Center, Beijing Hospital of Traditional Chinese Medicine, Capital Medical University, Beijing 100010, China
Xiao-Hong Sun, Department of Digestive, Peking Union Medical College Hospital, Beijing 100730, China
Su-Ning Chen, Department of Digestive, Shengjing Hospital of China Medical University, Shenyang 110004, Liaoning Province, China
Jing Wu, Department of Digestive, Beijing Shijitan Hospital, Capital Medical University, Beijing 100038, China
Author contributions: Li Z and Tao L contributed equally to this manuscript; summary and drafting of the manuscript were completed by Li Z and Tao L; the experiment was performed by all authors; acquisition, analysis, and interpretation was conducted by Li Z and Tao L; a critical review of the manuscript was conducted by Li Z, Tao L, and Zhang SS; All authors read the manuscript and approved the final version.
Supported by Capital Characteristic Study of Clinical Application, Beijing Municipal Science & Technology Commission, No. Z141107002514176; and Capital Health Development Research Project, No. 2018-2-2231.
Institutional review board statement: The study was reviewed and approved by the Ethics Committee of Beijing Hospital of Traditional Chinese Medicine of Capital Medical University (Approval No. 2018BL-026-02)
Clinical trial registration statement: This study is registered at: www.chictr.org.cn/; The registration identification number is ISRCTN17685397.
Informed consent statement: All study participants, or their legal guardian, provided informed written consent prior to study enrollment.
Conflict-of-interest statement: All authors have no conflict of interest.
Data sharing statement: No additional data are available.
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: http://creativecommons.org/Licenses/by-nc/4.0/
Corresponding author: Sheng-Sheng Zhang, PhD, Chief Doctor, The Digestive Center, Beijing Hospital of Traditional Chinese Medicine Capital Medical University, No. 23 Art Gallery Back Street, Dongcheng District, Beijing 100010, China. zhangshengsheng@bjzhongyi.com
Received: March 31, 2021
Peer-review started: March 31, 2021
First decision: May 28, 2021
Revised: May 28, 2021
Accepted: July 6, 2021
Article in press: July 6, 2021
Published online: July 28, 2021
Processing time: 117 Days and 0.5 Hours
Core Tip

Core Tip: This multicenter, randomized, double-blind, double-simulation study proved that Modified Xiaochaihu Decoction has a similar therapeutic effect to omeprazole in the treatment of patients with typical symptoms of gastroesophageal reflux disease and reflux esophagitis grades A and B. Modified Xiaochaihu Decoction was superior to omeprazole in improving lower esophageal sphincter resting pressure and reducing ineffective esophagus swallowing. The recurrence rate of symptoms was significantly lower than that of omeprazole within 1 mo and 3 mo after completing treatment. Modified Xiaochaihu Decoction may be an alternative treatment to proton pump inhibitor maintenance in patients with gastroesophageal reflux disease.