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:; 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:
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.
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

Gastroesophageal reflux disease (GERD) has a high prevalence worldwide, and its incidence is increasing annually. Modified Xiaochaihu Decoction (MXD) could relieve the symptoms of GERD, but the effects of MXD on GERD manifestations and relapse prevention need to be further explained. Therefore, we performed a prospective, double-blind, and double-simulation study.


To verify the efficacy of MXD for GERD and its effect on esophageal motility.


Using randomization, double-blinding, and a simulation design, 288 participants with GERD were randomized to the treatment group and control group and received herbs (MXD) plus omeprazole simulation and omeprazole plus herbs simulation, respectively, for 4 wk. The GERD-Q scale score and esophageal manometry were measured at baseline, after treatment, and at 1 mo and 3 mo follow-up visits when medication was complete to evaluate recurrence indicators.


The GERD-Q scale score in both groups decreased significantly compared to those before treatment (P < 0.01). However, no significant difference was observed between the two groups (P > 0.05). Esophageal manometry showed that participants with lower esophageal sphincter pressure reduction and the proportion of ineffective swallowing (more than 50%) improved in both groups from baseline (P < 0.01), especially in the treatment group (P < 0.05). The percentage of small intermittent contractions, large intermittent contractions, and increased pre-phase contractions in the treatment group significantly improved compared with baseline (P < 0.05) but did not improve in the control group (P > 0.05). There was no significant difference between the groups after treatment (P > 0.05). The percentage of weak esophageal contractility (distal contractile integral < 450 mmHg·s·cm), improved in both groups (P < 0.01), but no significant difference was observed between the groups after treatment (P > 0.05). The relapse rate in the treatment group was lower than that in the control group at the 1 mo (P < 0.01) and 3 mo follow-up (P < 0.05).


MXD has a similar therapeutic effect to omeprazole in mild-to-moderate GERD. The therapeutic effect may be related to increased pressure in the lower esophageal sphincter and reduced ineffective swallowing.

Keywords: Gastroesophageal reflux disease, Traditional Chinese medicine, Esophageal sphincter pressure, Gastroesophageal reflux disease-Q scale score, Modified Xiaochaihu Decoction

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.