©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
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, 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.
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
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
Core Tip
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.