| Objective:To observe the clinical efficacy and safety of treating Diarrhea-type Irritable Bowel Syndrome(Stagnation of liver qi and spleen deficiency)with Chailing Tongxie Yaofang,and to explore the possible mechanism of this method from the plasma level of substance P.Methods:The IBS-D patients who met the inclusion criteria were divided into the treatment group and the control group by randomized control method.The treatment group was treated with the traditional Chinese medicine “Chailing Tongxie Yaofang” for 4 weeks,while the control group was treated with the “Bifidobacterium triplet live tablets + Pivonium bromide tablets”.Primary endpoint:The response rate of abdominal pain and diarrhea in two groups after 2 and 4 weeks of treatment was evaluated by the digital rating scale of abdominal pain and Bristol stool character scale;Secondary endpoint:The changes of syndrome score table of traditional Chinese medicine,quality of life evaluation table,plasma SP level and safety index before and after treatment were observed to evaluate the effectiveness,safety and exploration of Chailing Tongxie Yaofang treatment Discuss the possible mechanism of action.Result:1.In this study,a total of 60 patients were included,among which 58 patients completed clinical observation.One patient was fall off from the treatment group and One patient was fall off from the control group,with a total loss rate of 3.33%.2.Abdominal pain and diarrhea response rate:24 patients(82.76%)in the treatmentgroup received diarrhea response and 25 patients(86.21%)met abdominal pain intensityresponse,which were significantly higher than those in the control group(P<0.05);theproportion of meeting any main endpoint index in the treatment group after 4 weeks washigher than that in the treatment group after 2 weeks(P<0.05).3.TCM syndromes:(1)Total score of TCM symptoms:After 4 weeks of treatment,the total score of TCM syndromes in both groups was lower than that before treatment(P<0.05),and the treatment group was significantly lower than that in the control group(P<0.05).(2)Single score of TCM symptoms:The scores of symptoms in both groups were lower than before treatment(P<0.05).There was no significant difference between the two groups in the scores of diarrhea,irritable,abdominal distension,ribs fullness,appetite loss,fatigue(P>0.05).In the treatment group,the scores of abdominal pain,defecation character were all lower than those of the control group(P<0.05).4.Overall efficacy:The total effective rate was 93.10% in the treatment group and 72.41% in the control group.The therapeutic effect of the treatment group was better than that of the control group(P<0.05).5.IBS quality of life scale score:(1)Total score:The total score in both groups was higher than that before treatment(P<0.05),and this in the treatment group was significantly higher than that in the control group(P<0.05).(2)Individual scores:IBS-QOL scores in both groups were increased compared with those before treatment(P<0.05).There was no significant difference in the scores of anxiety and appetite loss between the two groups(P>0.05).The scores of the treatment group in health anxiety,interpersonalrelationship,behavioral disorder,social function,physical intention and sexual behavior were all higher than those of the control group(P<0.05).6.Substance P level:After treatment,substance P level in both groups was lower than that before treatment(P<0.05),and this in the treatment group was significantly lower than that in the control group after treatment(P<0.05).7.Safety:No adverse events occurred in the treatment of the two groups,and no clinically significant abnormal change in the safety index before and after treatment.Conclusion:The clinical curative effect of Chailing Tongxie Yaofang for the treatment of Diarrheatype Irritable Bowel Syndrome(Stagnation of liver qi and spleen deficiency)is definite.It can improve the main clinical symptoms and quality of life of patients.Its mechanism may be related to lowering plasma P levels in patients. |
PDF Full Text Request