Clinical Study On Tongxieanchang Decoction In The Treatment Of Diarrhea-type Irritable Bowel Syndrome With Liver Depression And Spleen Deficiency

Purposes:Based on the results of previous animal experiments,this study used IBS-D patients with liver-stagnation and spleen-deficiency type as the observation object,comparing the clinical efficacy of Tongxie Anchang Recipe combined with Pinaverium Bromide Tablet and Pinaverium Bromide Tablet alone in the treatment of IBS-D.Simultaneously,to determine the efficacy of the two treatments for IBS-D,and to observe the efficacy and safety of Tongxie Anchang Recipe in the treatment of IBS-D.Methods:The cases were enrolled from Department of Gastroenterology Dongfang Hospital,Beijing University of Chinese Medicine from Month to December2018.Using randomized positive control research methods,64 subjects of irritable bowel syndrome with diarrhea(Rome IV criteria)were randomized into two groups.The three stages of the subject:1.Screening period(2 weeks before enrollment):the patients were distributed a diary card,then they recorded the frequency and traits of his or her stools every day for 14 consecutive days,the safety check were applied for qualified patients,basic information and related scale records were documented.2.Treatment period:the experimental group was given Tongxie Anchang Recipe(oral-200ml,twice a day)combined with Pinaverium bromide tablet(taken orally with meal,50mg,three times a day),and the control group wasgiven Pinaverium bromide tablet for 4 weeks.The two groups of patients needed to fill the questionnaire of IBS-SSS,IBS-QOL and hierarchical quantization scale after 2 weeks and 4 weeks of treatment.The patients recorded diary cards everyday for 28 consecutive days.When the treatment was finished,the subjects took safety examination within one week.3.Follow-up period:After 4 weeks of withdrawal,the two groups of patients would fill the questionnaire of IBS-SSS,IBS-QOL and hierarchical quantization scale,and the patients recorded daily dairy cards for 28 consecutive days as before.Results:1.According to SPSS21.0 statistical analysis,there was no significant difference in age,gender,disease duration,BMI score,IBS-SSS score and hierarchical quantization scale score between the two groups before treatment(P>0.05).2.IBS-SSS efficacy:①Comparison between groups:After 2 weeks treatment,the total effective rate was 73.3%in the experimental group and 60%in the control group.There was no significant difference between the two groups(Z=-1.445,P=0.149).After 4 weeks treatment,the total effective rate was 93.3%in the experimental group and 76.7%in the control group.There was a statistically significant difference between the two groups(Z=-2.611,P=0.008).②Comparison within group:the IBS-SSS scores of the test group before treatment and after 4 weeks treatment were statistically significant,the control group also improved after treatment,P values were respectively 0.000,0.OOO.The scores of the experimental group before treatment and 4 weeks after withdrawal were statistically significant,similar the control group,P values were respectively 0.000,0.000.3.Hierarchical quantization scale efficacy:①Comparison between groups:After 4 weeks treatment,the effective rate of the test group was 93.4%,and the control group was 70%.There was a statistically significant difference between the two groups(Z=-2.632,P=0.008).②Comparison within group:Hierarchical quantization scales of the test group before treatment and after 4 weeks treatment were statistically significant,the control group also improved after treatment,P values were respectively 0.000,0.OOO.The scores of the experimental group before treatment and 4 weeks after withdrawal were also statistically significant,similar the control group,P values were respectively 0.000,0.000.4.Single symptom:(1)abdominal pain:①Comparison between groups:After 4 weeks treatment,the effective rate of abdominal pain in the experimental group was 93.3%,and that in the control group was 54.3%.There was a statistically significant difference between the two groups(Z=-3.806,P=0.000).②Comparison within group:The abdominal pain scores of the test group before treatment and after 4 weeks treatment were statistically significant,the control group also improved after treatment,P values were respectively 0.000,0.001.The scores of the experimental group before treatment and after 4 weeks withdrawal were also statistically significant,similar the control group,P values were respectively 0.000,0.001.(2)Bloating:①Comparison between groups:There was no significant difference in the efficacy of bloating between the experimental group and the control group(Z=-1.301,P=0.193).②Comparison within group:The bloating scores of the test group before treatment and after 4 weeks treatment were statistically significant(Z=-2.365,P=0.018).While the scores of the experimental group before treatment and after 4 weeks withdrawal were not statistically significant(Z=-1.784,P=0.074).But the control group was not statistically significant within group comparison.(3)Diarrhea:①Comparison between groups:There was no significant difference in the efficacy of diarrhea between the experimental group and the control group(Z=-0.322,P=0.7488).②Comparison within group:the Diarrhea scores of the test group before using the drugs and after 4 weeks treatment were statistically significant,the control group also improved after treatment,P values were respectively 0.000,0.000.The scores of the experimental group before using the drugs and after 4 weeks withdrawal were statistically significant,similar the control group,P values were respectively 0.000,0.000.Conclusions:1.The effect of Tongxie Anchang Recipe combined with conventional western medicine is better than that of western medicine alone,especially in total efficiency andremission rate,improvement of abdominal pain,reducing hierarchical quantization table scores and relapse rate.2.Tongxie Anchang Recipe is safe.