Randomized controlled,double-blind and double-simulation clinical study of Tongxie Anchang Formula in the treatment of diarrhea irritable bowel syndrome with liver stagnation and spleen deficiency
Objective:To determine the efficacy of Tongxie Anchang Formula on diarrhea irritable bowel syndrome(IBS-D)patients with liver stagnation and spleen deficiency.Methods:Seventy-two patients with liver stagnation and spleen deficiency who visited Dongfang Hospital,Beijing University of Chinese Medicine from November 2019 to January 2022 were included to this study.The patients were randomly divided into the treatment group and the control group,with 36 patients in each group.The patients in the treatment group were given the Tongxie Anchang Formula and Pinaverium Bromide simulant(oral),and the control group was given the Tongxie Anchang Formula simulant and Pinaverium Bromide(oral),treating of 4 weeks.The main outcome indicators(overall effective rate,main symptoms),secondary outcome indicators[assessment of severity of irritable bowel syndrome(IBS-SSS),traditional Chinese medicine syndrome scale,and quality of life for irritable bowel syndrome patients(IBS-QOL)]and safety indexes were observed before and after treatment in both groups.Results:The effective rate in the treatment group was 81.25％(26/32),which was better than that in the control group[66.67％(20/30)],but there was no statistically significant difference between two groups.The overall effective rate of abdominal pain in the treatment group[93.75％(30/32)]was significantly better than that in the control group[66.67％(20/30)](P＜0.05).The treatment group was significantly better than the control group in improving abdominal pain,depression or agitation and irritability,fullness of two fanks,thirst,and so on(P＜0.05).Neither the treatment group nor the control group reported any discomfort after treatment,and all physical and chemical indicators physical and chemical indicators were normal.Conclusion:The overall efficacy of Tongxie Anchang Formula in the treatment of IBS-D with liver stagnation and spleen deficiency is equivalent to Pinaverium Bromide,it is superior to the Pinaverium Bromide in improving abdominal pain,depression or agitation and irritability,fullness of two flanks and thirst,Tongxie Anchang Formula have high safety.
Tongxie Anchang FormulaDiarrhoeal irritable bowel syndrome(IBS-D)Liver stagnation and spleen deficiency syndromeDouble-blind and double-simulationClinical study
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