Published online Aug 14, 2017. doi: 10.3748/wjg.v23.i30.5589
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
To assess the efficacy and safety of a Chinese herbal medicine (CHM), Xiangsha Liujunzi granules, in the treatment of patients with functional dyspepsia (FD).
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.
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).
Xiangsha Liujunzi granules offered significant symptomatic improvement in patients with FD.
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.