| Objective:Irritable bowel syndrome(IBS)is the most common functional gastrointestinal diseases in clinic.The incidence of IBS is very high in China even in the whole world.IBS is often divided into four subtypes based on the characteristics of stool.IBS-D is the most common subtype,accounting for about 74%of all patients.western medicine mainly uses symptomatic treatment,But there have the following deficiencies:firstly,the curative effect is not stable,secondly,the IB S is easy to relapse,thirdly it brings great burden to the patients,which seriously affects the quality of life of patients.Recently,a number of clinical studies have shown that TCM treatment which based on syndrome differentiation plays an important role in the treatment of this disease.However,a strict randomized,controlled,double-blind,double simulation clinical trial is lacking to confirm the effectiveness and safety of TCM treatment.So this study is going to use randomized,controlled,double-blind and double simulation methods to observe the clinical effect of TCM syndrome differentiation in the treatment of IBS-D,comparing with placebo and positive control drugs.our aim is to evaluate the efficacy and safety of TCM in the treatment of IBS-D.At the same time,we also study the relationship between the patients’ quality of life and the TCM syndrome.Methods:All 72 cases of the clinical study wre from the outpatient department of gastroenterology department of Beijing University of Chinese Medicine,Dongfang Hospital.The 72 cases were in line with the IBS-D entry standard.All of them were included in the study the quality of life.This study used a randomized double-blind-double-imitate method.All cases were randomly divided into the experimental group(TCM syndrome differentiation),the placebo control group and the positive drug-control group.there are 36 cases in the experimental group,18 cases in the placebo control group,and 18 cases in the positive drug-control group.The experimental group was given the traditional Chinese medicine granules and the analogue of dialectical Trimebutine Maleate Capsules.The placebo group was given the analogue of Chinese medicine granules and the analogue of Trimebutine Maleate Capsules,positive-drug control group was given the Trimebutine Maleate Capsules and the analogue of Chinese medicine granules.The treatment lasted for 8 weeks,the security checks were carried out(including blood routine,urine routine,stool routine,occult blood,liver and kidney function,ECG)before and after treatment.Before the treatment,general information,TCM symptoms and scores,IBS-D symptom severity score(IBS-SSS)and quality of life were assessed respectively,and the relationship between IBS-D quality of life and TCM syndromes was evaluated.After 8 weeks,we evaluated the clinical efficacy,TCM symptom score,severity of symptoms,quality of life.We made the comparative analysis of difference between the test group and placebo-control group and positive drug-control group,to evaluate the efficacy and safety of TCM method in the treatment of IBS-D.The statistical analysis of data was used in the SPSS 20 statistical software.Results:1.The quality of life and its relationship with TCM syndromes:(1)there are differences in the dimensions including the Interference with activity(IN),social reaction(SR)and total score between male and female,the difference is statistically significant(P<0.05),and male’ score is higher than that of women.(2)there is no statistically difference in the quality of life between the different ages(P>0.05).(3)there is no statistically difference in the quality of life between the different cultural degrees(P>0.05).(4)except for the social response(SR)dimension,there were no statistically differences in the other dimensions and the total score between the duration of disease(P<0.05).(5)except for dysphoria(DY),Interference with activity(IN),social reaction(SR)and relationship(RL)of four dimensions and total score,there is no statistically difference in the quality of life between different severity(P>0.05),the total score of QOL in patients with the severity of symptoms are positive correlation.(6)each dimension of the quality of life and the total score have no statistically difference between different TCM syndromes(P>0.05).(7)there are statistically significant differences in all dimensions of quality of life in the same TCM syndromes(P<0.05),patients with liver stagnation and spleen deficiency have higher score in health worries(HW),Food avoidance(FA),patients with dampness due to spleen deficiency have higher score in Food avoidance(FA),patients with spleen kidney yang deficiency have higher scoer in health worries(HW),Food avoidance(FA),Sexual(SX),Dysphoria(DY)and Interference with activity(IN)integral is also higher.2.the evaluation of the efficacy of IBS-D:(1)the total effective rate of the experimental group is 60%,the total effective rate of the placebo control group is 75%,and the total effective rate of the positive control group is 66.67%.There is no statistically significant difference in the total effective rate in the three groups(P>0.05).The markedly effective rate in the experimental group is 23.33%,the placebo control group is 18.75%,the positive control group is 13.33%,and there is no statistically significant difference in the markedly effective rate in the three groups(P>0.05),but the markedly effective rate in the experimental group is the highest.(2)The experimental group,placebo control group and positive drug-control group can improve the IBS-SSS scores comparing with treatment before,the differences are statistically significant(P<0.05,),but there is no statistically significant difference in the comparation of three groups,(P>0.05).(3)The experimental group,placebo controlled group and positive drug-controlled group can improve the PRO scores comparing with the treatment before,the differences are statistically significant(P<0.05),but there is no statistically significant difference in the comparation of three groups,(P>0.05).(4)experimental group and positive drug-controlled group in TCM symptom score comparing with treatment before,but there are no significant difference(P>0.05),placebo controlled-group in TCM symptom score compared with treatment before,there is statistically significant differences(P<0.05),we make the comparison in three groups after the treatment,there is nostatistically significant difference(P>0.05).(5)No obvious adverse reactions were observed before and after treatment,and there was no obvious adverse reaction.Conclusion:1.the influencing factors of IBS-D’s quality of life and its relationship with TCM syndromes:education level and IBS symptom severity are closely related to the quality of life of IBS-D patients.The course of IBS-D does not affect the quality of life of the patient.Whether sex and age have an impact on the quality of life is controversial and need to be further studied.TCM syndrome has a significant influence on the quality of life of IBS-D patients.2.Study on the curative effect evaluation of IBS-D:the experimental group,positive drug group and placebo group can improve therapeutic efficacy.But there is no statistically significant difference in these three groups,but the markedly effective rate in the experimental group is the highest.the experimental group,positive-drug group and the placebo group can improve the severity of the disease and PRO,but there is no statistically significant difference.The experimental group and the positive-drug group can reduce the TCM symptom integral,but there is no statistically significant difference.While There has statistically significant difference in the placebo group after treatment.TCM treatment of IBS-D has no obvious adverse reactions. |
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