Clinical Trials Study
Copyright ©The Author(s) 2017. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Gastroenterol. Aug 14, 2017; 23(30): 5589-5601
Published online Aug 14, 2017. doi: 10.3748/wjg.v23.i30.5589
Efficacy and safety of Xiangsha Liujunzi granules for functional dyspepsia: A multi-center randomized double-blind placebo-controlled clinical study
Lin Lv, Feng-Yun Wang, Xiang-Xue Ma, Zhen-Hua Li, Sui-Ping Huang, Zhao-Hong Shi, Hai-Jie Ji, Li-Qun Bian, Bei-Hua Zhang, Ting Chen, Xiao-Lan Yin, Xu-Dong Tang
Lin Lv, Feng-Yun Wang, Xiang-Xue Ma, Zhen-Hua Li, Hai-Jie Ji, Li-Qun Bian, Bei-Hua Zhang, Ting Chen, Xiao-Lan Yin, Xu-Dong Tang, Department of Gastroenterology, Xiyuan Hospital of China Academy of Chinese Medical Sciences, Beijing 100091, China
Sui-Ping Huang, Department of Gastroenterology, Guangdong Province Traditional Chinese Medical Hospital, Guangzhou 510105, Guangdong Province, China
Zhao-Hong Shi, Department of Gastroenterology, Wuhan Integrated TCM and Western Medicine Hospital, Wuhan 430022, Hubei Province, China
Author contributions: Wang FY and Tang XD performed the research and drafted the manuscript; Li ZH, Huang SP and Shi ZH contributed to the development of the study protocol; Lv L contributed to the development of the study protocol and the drafting of the manuscript; Bian LQ, Zhang BH, Chen T and Yin XL recruited the participants; Ma XX and Ji HJ contributed to database management and statistical analysis; all authors approved the final version of the manuscript; Lv L took responsibility for the integrity of the work as a whole, from inception to published article.
Supported by the Major State Basic Research Development Program of China (973 Program), No. 2013CB531703; National Nature Science Foundation of China, No. 81503567 and No. 81673853; and the China Postdoctoral Science Foundation, No. 2015M1227 and No. 2016T90195.
Institutional review board statement: The study was reviewed and approved by the Ethic Committee of Xiyuan Hospital of China Academy of Chinese Medical Sciences.
Informed consent statement: All study participants, or their legal guardian, provided written informed consent prior to study enrollment.
Clinical trial registration statement: This study was registered at www.chictr.org.cn, and the registration identification number is ChiCTR-TRC-13003200. This study was also registered at https://clinicaltrials.gov/, and the registration identification number is NCT02762136.
Conflict-of-interest statement: The authors declare that they have no competing interests. Neither the funding agency nor any outside organization has a role in study design or manuscript preparation.
Data sharing statement: No additional data.
Open-Access: This article is an open-access article which was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution Non Commercial (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/
Correspondence to: Xu-Dong Tang, Director, Department of Gastroenterology, Xiyuan Hospital of China Academy of Chinese Medical Sciences, No. 1, Xiyuan Caochang, Beijing 100091, China. txdly@sina.com
Telephone: +86-10-62835678 Fax: +86-10-62860397
Received: October 14, 2016
Peer-review started: October 19, 2016
First decision: December 2, 2016
Revised: May 12, 2017
Accepted: June 18, 2017
Article in press: June 19, 2017
Published online: August 14, 2017
Processing time: 303 Days and 9.5 Hours
Abstract
AIM

To assess the efficacy and safety of a Chinese herbal medicine (CHM), Xiangsha Liujunzi granules, in the treatment of patients with functional dyspepsia (FD).

METHODS

We performed a randomized, double-blind, placebo-controlled trial with patients from three centers. Two hundred and sixteen subjects diagnosed with FD according to ROME III criteria and confirmed by upper gastrointestinal endoscopy and spleen-deficiency and Qi-stagnation syndrome were selected to receive Xiangsha Liujunzi granules or placebo for 4 wk in a 2:1 ratio by blocked randomization. The subjects also received follow-up after the 4-wk intervention. Herbal or placebo granules were dissolved in 300 mL of water. Participants in both groups were administered 130 mL (45 °C) three times a day. Participants were evaluated prior to and following 4 wk of the intervention in terms of changes in the postprandial discomfort severity scale (PDSS) score, clinical global impression (CGI) scale score, hospital anxiety and depression scale (HADS) score, traditional Chinese medicine symptoms score (SS), scores of various domains of the 36-item short form health survey (SF-36), gastric emptying (GE) and any observed adverse effects.

RESULTS

Compared with the placebo group, patients in the CHM group showed significant improvements in the scores of PDSS, HADS, SS, SF-36 and CGI scale (P < 0.05 or P < 0.01). They also showed the amelioration in the GE rates of the proximal stomach and distal stomach (P < 0.05 or P < 0.01).

CONCLUSION

Xiangsha Liujunzi granules offered significant symptomatic improvement in patients with FD.

Keywords: Functional dyspepsia; Chinese herbal medicine; Xiangsha Liujunzi; Efficacy; Randomized controlled trial

Core tip: Functional dyspepsia (FD) is a common clinical functional gastrointestinal disease with a very high incidence, seriously affecting the quality of life of patients. However, current chemical drugs do not achieve good curative effects. In the present study we performed a randomized, double-blind, placebo-controlled trial to assess the efficacy and safety of a Chinese herbal medicine, Xiangsha Liujunzi granules, in the treatment of patients with FD. We found that Xiangsha Liujunzi granules offered significant symptomatic improvement in patients with FD without adverse effects.