OBJECTIVETo evaluate the efficacy and safety of Yigan Fupi Decoction (YFD) in the treatment of irritable bowel syndrome with diarrhea (IBS-D) patients.

METHODSA randomized controlled clinical trail was carried out in patients with IBS-D. All patients were randomly assigned to the treatment group (58 cases, treated with YFD) and the control group (58 cases, treated with Pinaverium Bromide Tablet). The treatment course was 4 weeks for all patients. The total effective rate, the stool property and state, the quality of life (QOL), and TCM syndrome efficacy were assessed by IBS bowel symptom severity scale (IBS-BSS), IBS defecation state questionnaire (IBS-DSQ), IBS quality of life questionnaire (IBS-QOL), and traditional Chinese medicine pattern curative effect scoring system (TCM-PES) before and after treatment.

RESULTSThere was no statistical difference in the total effective rate between the two groups (82.76% vs. 77.59%, P > 0.05). The treatment group was superior in the total IBS-BSS integral to the control group (P < 0.05). The total effective rate of improving the stool property was better in the treatment group than in the control group (81.03% vs. 72.41%, P < 0.05). Besides, the number of days for emergent defecation among 10 days was less in the treatment group than in the control group (P < 0.05). The improvement of the total IBS-QOL integral and the total integral of TCM syndrome were better in the treatment group than in the control group (P < 0.01). The total effective rate of TCM-PES was better in the treatment group than in the control group (84.48% vs. 70.69%, P < 0.05).

CONCLUSIONYFD was effective in the treatment of IBS-D patients of Gan-qi invading Pi syndrome, and could effectively relieve bowel symptoms, improve the stool property and the defecation frequency, elevate their QOL, and attenuate Gan-qi invading Pi syndrome with favorable safety and compliance.