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World J Gastroenterol. 2017 Aug 14;23(30):5589-5601. 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.

Author information

1
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.

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:

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

PMID:
28852318
PMCID:
PMC5558122
DOI:
10.3748/wjg.v23.i30.5589
[Indexed for MEDLINE]
Free PMC Article

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