Efficacy and safety of Xiangsha Liujunzi granules for functional dyspepsia: A multi-center randomized double-blind placebo-controlled clinical study

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.

Figure 1

Study design. There was a screening period of 2 wk before randomization. Blood draw, gastroscopy, and physical examination were performed and written informed consent were obtained from all patients in this period. Study visits were arranged at -2 wk, 0 wk, 2 wk, 4 wk and 8 wk. Some questionnaires were performed by phone during the treatment period, and this was followed by a 4-wk follow-up period.

Math 1

Math(A1).

Figure 2

Gastric ultrasonography.

Figure 3

Flow of participants in the study.

Figure 4

Postprandial discomfort severity scale. A: Postprandial fullness; B: Early satiety; C: Epigastric pain; D: Epigastric burning. ^aP < 0.05 vs placebo group. CHM: Chinese herbal medicine.

Figure 5

Clinical global impression scale. A: Very much worse since the initiation of treatment; B: Worse since the initiation of treatment; C: Slightly worse since the initiation of treatment; D: No change from baseline; E: Slightly improved since the initiation of treatment; F: Significantly improved since the initiation of treatment; G: Very much improved since the initiation of treatment. CHM: Chinese herbal medicine.

Figure 6

Traditional Chinese medicine symptom scores. ^aP < 0.05, ^bP < 0.01 vs placebo group. TCM: Traditional Chinese medicine; CHM: Chinese herb medicine.

Figure 7

MOS 36-item short-form health survey. GH: General health; PF: Physical functioning; RP: Role physical; RE: Role emotional; SF: Social functioning; BP: bodily pain; VT: Vitality; MH: Mental health. ^aP < 0.05, ^bP < 0.01 vs placebo group. CHM: Chinese herb medicine.

Figure 8

Hospital anxiety and depression scale. ^aP < 0.05, ^bP < 0.01 vs placebo group. CHM: Chinese herb medicine; HADA: Hospital anxiety and depression scale-Anxiety; HADD: Hospital anxiety and depression scale-Depression.