1. ObjectiveTo observe clinical efficacy of Sini Powder and Xiangsha Liujunzi Decoction in treating diarrhea-predominant irritable bowel syndrome (liver stagnation and spleen deficiency syndrome),through comparing the symptomatic quantization,IBS-QOL,SAS,SDS before and after treatment.2. Methods2.1Data collection:60patients of IBS-D(liver stagnation and spleen deficiency syndrome)are randomly divided into two groups arranged by registration order,each group30cases.General data of the two groups of patients such as gender, age, degree of disease and syndrome score has no statistical significance by statistical analysis(P>0.05),is comparable.2.2Treatment:The treatment group is given Sini Powder and Xiangsha Liujunzi Decoction, the control group is given Live Combined Bifidobacterium,Lactobacillus and Enterococcus Capsules(Trade name:Bifico).The course of treatment was2weeks.Record the changes of the condition at the0,2,4th weekend. Give the safety observation(including general physical examination such as blood, urine, stool routine, liver function kidney function, electrocardiogram, etc)and the observation of clinical efficacy(including the change of symptomatic quantization,IBS-QOL, SAS,SDS before and after treatment.)2.3Data processing:After treatment,using SPSS20.0to analyze the data.Measurement data which conforms to normal distribution is analyzed by t test, data do not conform to the normal distribution is analyzed by non-parametric test;enumeration data is analyzed by χ2test,ranked data is analyzed by rank sum test.3. Results3.1Primary symptom efficacy evaluation:As for the diarrhea in treatment group,18cases are significantly effective with a total effective rate of96.67%;in control group,8cases are significantly effective with a total effective rate of93.33%.As for the bellyache in treatment group,18cases are significantly effective with a total effective rate of96.67%;in control group,5cases are significantly effective with a total effective rate of90.00%. As for the irritable in treatment group,3cases are significantly effective with a total effective rate of76.67%;in control group,2cases are significantly effective with a total effective rate of66.67%.As for the sigh in treatment group,6cases are significantly effective with a total effective rate of80.00%;in control group,1case is significantly effective with a total effective rate of73.33%.3.2Primary symptoms efficacy comprehensive evaluation:3cases are cured in treatment group with a total curative rate of90.00%;1case is cured in control group with a total curative rate of73.3%.Total curative rate and total effective rate in treatment group are higher than in control group(.P<0.05).3.3Syndrome efficacy evaluation:2cases are cured and23cases are significantly effective with a total effective rate of96.67%in treatment group;none case is cured and2cases are significantly effective with a total effective rate of96.67%in control group.Total curative rate and total significantly effective rate in treatment group are higher than in control group(P<0.05),total effective rate of both groups are the same.3.4The scores of IBS-QOL,SAS,SDS are all improved after treatment,and the curative effect is remarkable in treatment group(P<0.05).4. ConclusionThis clinical study shows that Sini Powder and Xiangsha Liujunzi Decoction is better than control group in treating diarrhea-predominant irritable bowel syndrom (liver stagnation and spleen deficiency syndrome),especially in symptoms of diarrhea and bellyache,and has certain improvement effect for the patient’s quality of life,anxiety and depression.To combine with modern pharmacological research, Sini Powder and Xiangsha Liujunzi Decoction can regulate gastrointestinal dynamics,visceral sensitivity and hypothalamus-pituitary-adrenocortical axis(HPA).It has good curative effect in the treatment of IBS-D (liver stagnation and spleen deficiency syndrome),without obvious ADR(adverse drug reaction),is suitable for clinical application. |