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
ARTICLE HIGHLIGHTS
Research background

Gastroesophageal reflux disease (GERD) has a high prevalence worldwide, and its incidence is increasing annually. According to the preliminary experiment of the research group, Modified Xiaochaihu Decoction (MXD) could relieve the symptoms of GERD.

Research motivation

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.

Research objectives

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

Research methods

Using randomization, double-blinding, and a simulation design to compare the GERD-Q scale score and esophageal manometry between patients under the treatment of MXD (treatment group) and omeprazole (control group).

Research results

In total, 288 patients were divided into the treatment group and control group. 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 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). The percentage of weak esophageal contractility (distal contractile integral < 450 mmHg·s·cm) improved in both groups (P < 0.01). 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).

Research conclusions

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.

Research perspectives

Our results supported that MXD has a similar therapeutic effect to omeprazole in mild-to-moderate GERD and could improve esophageal motility.