Randomized Controlled Trial
Copyright ©The Author(s) 2020. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Gastroenterol. Jul 28, 2020; 26(28): 4170-4181
Published online Jul 28, 2020. doi: 10.3748/wjg.v26.i28.4170
Epigastric pain syndrome: What can traditional Chinese medicine do? A randomized controlled trial of Biling Weitong Granules
Yan-Dong Wen, Fang Lu, Ying-Pan Zhao, Ping Wang, Qian Yang, Jun-Xiang Li, Hui-Zhen Li, Li-Li Chi, Zheng-Hua Zhou, Yan-Ping Tang, Jin-Kang Xu, Yang Zhao, Xu-Dong Tang
Yan-Dong Wen, Ying-Pan Zhao, Ping Wang, Xu-Dong Tang, Department of Gastroenterology, Xiyuan Hospital of China Academy of Chinese Medical Sciences, Beijing 100091, China
Fang Lu, Yang Zhao, Institution of Clinical Pharmacology, Xiyuan Hospital of China Academy of Chinese Medical Sciences, Beijing 100091, China
Qian Yang, Department of Gastroenterology, Hebei Provincial Hospital of Chinese Medicine, Shijiazhuang 050011, Hebei Province, China
Jun-Xiang Li, Department of Gastroenterology, Dongfang Hospital, Beijing University of Chinese Medicine, Beijing 100078, China
Hui-Zhen Li, Second Affiliated Hospital of Tianjin University of Traditional Chinese Medicine, Tianjin 300250, China
Li-Li Chi, Department of Gastroenterology, The Affiliated Hospital of Shandong University of Traditional Chinese Medicine, Jinan 250014, Shandong Province, China
Zheng-Hua Zhou, Department of Gastroenterology, First Teaching Hospital of Tianjin University of Traditional Chinese Medicine, Tianjin 300381, China
Yan-Ping Tang, Department of Gastroenterology, Tianjin Nankai Hospital, Tianjin 300100, China
Jin-Kang Xu, Department of Gastroenterology, The Kunshan Hospital Affiliated to Nanjing University of Chinese Medicine, Kunshan 215300, Jiangsu Province, China
Author contributions: Tang XD, Wen YD, and Lu F designed the study; Lu F and Zhao YP drafted the manuscript; Zhao Y contributed to statistical analysis; Wen YD, Zhao YP, Wang P, Yang Q, Li JX, Li HZ, Chi LL, Zhou ZH, Tang YP, and Xu JK contributed to data collection; Tang XD, Wen YD, and Wang P revised the manuscript; all authors read and approved the final manuscript.
Supported by National New Drug Innovation Program, No. 2017ZX09304003; Special Research on Modernization of Traditional Chinese Medicine in the National Key Research and Development Program in the 13th Five-Year Plan Demonstrative Research, No. 2017YFC1703703.
Institutional review board statement: This study was approved by the IRB of Xiyuan Hospital of China Academy of Chinese Medical Sciences (No. 2016XL011).
Clinical trial registration statement: This study is registered at https://http://www.chictr.org.cn/showproj.aspx?proj=18562. The registration identification number is ChiCTR­IPR­17010953./
Informed consent statement: All study participants, or their legal guardian, provided informed written consent prior to study enrollment.
Conflict-of-interest statement: We declare that we have no potential conflicting interests related to this paper.
Data sharing statement: No additional data are available.
CONSORT 2010 statement: The authors have read the CONSORT 2010 Statement—checklist of items, and the manuscript was prepared and revised according to the CONSORT 2010 Statement—checklist of items.
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: Xu-Dong Tang, MD, PhD, Chief Doctor, Professor, Department of Gastroenterology, Xiyuan Hospital of China Academy of Chinese Medical Sciences, No. 1 Xiyuancaochang, Haidian District, Beijing 100091, China. txdly@sina.com
Received: April 8, 2020
Peer-review started: April 8, 2020
First decision: June 13, 2020
Revised: June 25, 2020
Accepted: July 16, 2020
Article in press: July 16, 2020
Published online: July 28, 2020
ARTICLE HIGHLIGHTS
Research background

Recent research has suggested that although prokinetic agents, acid suppressors, and radical treatment for Helicobacter pylori infection may be effective in patients with functional dyspepsia (FD), a large proportion of patients still failed to respond to these treatments or may suffer from severe adverse reactions. Many traditional Chinese medicinal (TCM) herbs can regulate the status of entire body and have shown special advantages in the treatment of functional diseases.

Research motivation

Although the currently available drugs for FD can, to some extent, improve the symptoms, they are still ineffective or have severe adverse reactions in some patients. The present study was designed to verify the efficacy of Biling Weitong Granules (BLWTG), a TCM herbal compound formula, in alleviating the epigastric pain syndrome (EPS) in FD patients, in an attempt to provide an effective prescription for the clinical treatment of this disease.

Research objectives

The aim of the study was to evaluate the clinical efficacy and safety of BLWTG in treating EPS in patients with FD.

Research methods

In this multicenter, stratified, randomized, double-blind, placebo-controlled, parallel group clinical trial, eligible patients were randomized into the BLWTG and placebo groups who were treated for 6 wk. Efficacy indicators including the severity and frequency of EPS, the resolution rate of epigastric pain, the total score of FD symptoms and the Functional Digestive Disorders Quality of Life Questionnaire scores and safety indicators including adverse events were observed and compared. Two-sided tests were used for all analyses. P ≤ 0.05 was regarded as significant unless otherwise indicated. A 95% confidence interval was used. Based on the intention-to-treat principle, the last observation carried forward method was applied for imputing missing data (i.e. the missing efficacy data was replaced by the efficacy data of the last follow-up). The efficacy analysis was mainly based on a full analysis set, and the central effect was considered.

Research results

The baseline demographic data and clinical characteristics, such as epigastric pain symptoms, pain intensity, and frequency of attacks, were matched between the two groups before randomization. After 6 wk of treatment and after the center effect was eliminated, the epigastric pain was significantly improved in 28.33% and 85.59% of the patients in the placebo and BLWTG groups, respectively (P < 0.05). At 6 wk, the resolution rate of epigastric pain was 15% and 69.49% in the placebo and BLWTG groups, respectively (P < 0.05). The differences of total FD clinical score between these two groups were significant (P < 0.05) at 2, 4 and 6 wk (P < 0.05). The scores of each item and the total score in the Functional Digestive Disorders Quality of Life Questionnaire showed significant differences between the two groups at 6 wk after both the center and interaction effects were eliminated (P < 0.05). There was no significant difference in the incidence of adverse events between the two groups, and no serious adverse event was noted during the observation.

Research conclusions

Compared with placebo, BLWTG markedly improved EPS in FD patients without causing serious adverse reactions. BLWTG may be a good analgesic option for EPS in FD patients.

Research perspectives

This study only included FD patients with EPS and the results might not be applicable for patients with upper gastrointestinal pain due to other upper abdominal diseases. Our study did not include Helicobacter pylori-positive patients, which also limited the extrapolation of BLWTG to other patient populations. BLWTG is composed of 11 TCM ingredients and its complex action mechanisms warrant further investigation.