The effect of Xiang-Sha-Liu-Jun-Zi tang (XSLJZT) on irritable bowel syndrome: A randomized, double-blind, placebo-controlled trial

Background: Irritable bowel syndrome (IBS) is characterized by chronic, recurrent abdominal pain or abdominal discomfort and changes in defecation habits. Xiang-Sha-Liu-Jun-Zi tang (XSLJZT) is a traditional Chinese medical formula that can modulate gastrointestinal disturbance. Purpose: To investigate the therapeutic effect of XSLJZT on IBS. Materials and methods: This study was designed as a double-blind, randomized, controlled preliminary study. Eighty patients with IBS were assigned to a control group (CG, 40 patients) that received oral administration of an XSLJZT 10% comparator (3.0 g three times daily) for 28 days or to a treatment group (TG, 40 patients) that received XSLJZT. The primary outcome measure was changes in scores on the Gastrointestinal System Rating Scale-IBS. The secondary outcome measures were changes in scores on the irritable bowel syndrome-quality of life (IBS-QOL) and World Health Organization-quality of life-brief. Results: A total of 63 patients completed the study (n = 31 for the CG; n = 32 for the TG). The TG were discovered to have significantly lower diarrhea scores than the CG at V2 (second assessment) compared with V1 (first assessment, baseline) (mean change +/- SD: CG: 0.19 +/- 1.33 vs. TG: -0.38 +/- 0.91, p = 0.05). The scores for Item 28 on the IBS quality of life (QOL) scale (I feel frustrated that I cannot eat when I want because of my bowel problems) were lower in the CG at V3 (third assessment) compared with V1 but slightly higher in the TG (CG: -0.48 +/- 0.89 vs. TG: 0.03 +/- 0.65, p = 0.01). Conclusion: Oral administration of XSLJZT (3.0 g) for 28 days lowered the mean diarrhea score in patients with IBS, indicating that the patients in the TG had greater diarrhea improvement than those in the CG. The present study used 10% XSLJZT as a comparator, and the different items of the Gastrointestinal System Rating Scale IBS, IBS-QOL, and World Health Organization Quality of Life-Brief were scored separately. Therefore, the selection of an appropriate comparator or placebo and score assessment are crucial issues for future study.