Efficacy and safety of Xiangsha Liujunzi granules for functional dyspepsia: A multi-center randomized double-blind placebo-controlled clinical study
World Journal of Gastroenterology Aug 18, 2017
Lv L, et al. – The authors performed this study to evaluate the efficacy and safety of a Chinese herbal medicine (CHM), Xiangsha Liujunzi granules, in the treatment of patients with functional dyspepsia (FD). In patients with FD, Xiangsha Liujunzi granules offered significant symptomatic improvement.
Methods- The authors conducted a randomized, double-blind, placebo-controlled trial with patients from 3 centers.
- According to ROME III criteria, 216 subjects diagnosed with FD 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.
- After the 4-wk intervention, the subjects also received follow-up.
- They dissolved herbal or placebo granules in 300 mL of water.
- In both groups, participants were administered 130 mL (45 °C) three times a day.
- They evaluated participants 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.
- In the CHM group, patients demonstrated significant improvements in the scores of PDSS, HADS, SS, SF-36 and CGI scale compared with the placebo group (P < 0.05 or P < 0.01).
- Also, they demonstrated the amelioration in the GE rates of the proximal stomach and distal stomach (P < 0.05 or P < 0.01).
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