| Objective:To observe the clinical efficacy of Compound Glutamine Entersoluble Capsules in treating diarrhea irritable bowel syndrome(IBS-D)and evaluate its efficacy and safety through randomized,double-blind and placebo-controlled trials.Methods:A total of 66 patients with IBS-D from the outpatient department,inpatient department and endoscopy center of spleen and stomach department of Wangjing hospital,Chinese Academy of traditional Chinese medicine were selected for the research.Adopting the principle of 2:1 superior clinical trial,the study randomly divided the patients into two groups by the random number table method.The experimental group was given a compound glutamine enteric coated capsule and the control group a placebo.Both groups were treated for 4 weeks and followed up for 4 weeks.The patients who met the enrollment conditions were visited for 4 times.The IBS-SSS scores,stool frequency and character scores,IBS-QOL scores,SAS and SDS scores of the two groups before and after treatment were recorded at each visit node including the start date of medication,2 weeks after medication,4 weeks after medication and 4 weeks after stopping treatment.Results were conducted a statistical analysis by spss23.0 statistical software for.Through Kolmogorov-sminov test,the continuous variables in line with normal distribution are expressed by means ±standard deviation.The differences between the two groups are compared by t test and Z test,and the multi groups by one-way ANOVA.Those who do not conform to the normal distribution are represented by quartile m(q25,Q75),the differences between the two groups are compared by rank sum test,and the differences between multiple groups by Knuskal-Wallis H test.The frequency(percentage)was used to represent the grade data,and the chi square test was used for multi group and inter group comparison.T-test,Z-test or chi square test were selected to conduct comparison of the differences in sociodemographic characteristics and other basic information between different groups,The hypothesis test level of the main efficacy index was set as α=0.025(one side).For other indicators,the statistical hypothesis test level is set as α=0.05(bilateral).The factors considered in subgroup analysis include different syndrome differentiation types of traditional Chinese medicine,gender,combined medication and medication compliance..Research results:1.A total of 64 patients in the two groups who met the criteria were included in the final statistics,including 42 cases in the experimental group and 22 cases in the control group.There was no obvious differences in age,gender,BMI,smoking and drinking between the two groups,and there was no significant abnormality in theadmission examination and laboratory indexes.2.After 4 weeks of treatment,the effective rate in the experimental group was 76.2%,including 19 cured cases,4 markedly effective cases,9 effective cases and 10 ineffective cases.The effective rate of the control group was 31.8%,including 1 cured case,0 markedly effective case,6 effective cases and 15 ineffective cases.There was a significant difference between the two groups(P<0.001).According to the subgroup analysis of the experimental group based on the TCM syndrome type,it was found that the patients with spleen deficiency and dampness excess syndrome had the highest effective rate(84.62%),but the difference was not statistically significant.IBS-SSS in the experimental group decreased gradually at different time points,and the difference between the four groups was statistically significant.There was a statistically significant difference among the four groups:before medication and 2 weeks after medication,before medication and 4 week medication,before medication and 4 weeks after stopping treatment,2 week medication and 4 weeks after stopping treatment(all P<0.05).The experimental group was better than the control group at 4 weeks medication and 4 weeks stopping treatment,and the difference was statistically significant(P<0.05).In the control group,IBS-SSS had no significant difference among the four groups at different time nodes.There was significant difference between before and 2 weeks,before and 4 weeks,and before and 4 weeks after withdrawal.The experimental group was better than the control group at 4 weeks after administration and 4 weeks after withdrawal,and the difference was statistically significant(P<0.05).3.Compare the scores of daily average defecation traits of the two groups before medication,2 weeks after medication,4 weeks after medication and 4 weeks after stopping treatment.The average daily defecation times of the experimental group gradually decreased at different time nodes.The difference between the four groups was statistically significant.There was a statistically significant difference among the four groups:before medication and 2 weeks after medication,before medication and 4 week medication,before medication and 4 weeks after stopping treatment,2 week medication and 4 week medication,2 week medication and 4 weeks after stopping treatment(all P<0.05).There was no significant difference among the four groups in the daily average defecation traits of the control group at different time nodes.There was significant difference between before medication and 2 week medication,before medication and 4 week medication,and before medication and 4 week after stopping treatment.Four weeks after stopping treatment,the experimental group was better than the control group,and the difference between the two groups was statistically significant(P=0.002).4.Before taking medicine,the IBS-QOL of the experimental group was 98.7(68.6168.0)and that of the control group was 112.6(59.8,174.6).There was no significant difference between the two groups.The IBS-QOL of the test group was 48.4(31.7,62.9)and that of the control group was 86.7(36.3,168.4).There was significant difference between the two groups(P=0.002).Compared with that before medication,IBS-QOL in the test group decreased significantly after 4 weeks of medication(P<0.001),and there was no significant difference in the control group before and after medication(P=0.405).Before taking medicine,the SAS of the experimental group was 41.7±9.3 and that of the control group was 35.6±8.3.There was no significant difference between the two groups.The SDS of the test group was 41.1 ± 8.6 and that of the control group was 35.6±8.3 for 4 weeks.There was significant difference between the two groups(P=0.016).Compared with that before taking medicine,SAS in the test group decreased significantly after taking medicine for 4 weeks,and the difference was statistically significant(P=0.002).Before taking the medicine,the SDS of the experimental group was 41.5 ± 12.7 and that of the control group was 40.2± 10.1.There was no significant difference between the two groups.The SDS of the test group was 33.9± 7.2 and that of the control group was 40.0± 11.0.There was a significant difference between the two groups.Compared with that before taking medicine,the SDS of the test group decreased significantly after taking medicine for 4 weeks,and the difference was statistically significant(P<0.05).5.Multivariate analysis indicated that there was no correlation between taking drugs and each outcome index,and it had no correlation with SDS,SAS,IBS-QOL,defecation times,defecation traits and IBS-SSS before taking drugs;There was no correlation with the outcome indexes after 2 weeks,but with SDS,SAS,IBS-QOL and IBS-SSS after 4 weeks.The correlation coefficients were-0.319,-0.299,-0.498 and-0.308.In addition,there was a negative correlation between medication and defecation times,defecation characters and IBS-SSS after 4 weeks of drug withdrawal,and the correlation coefficients were-0.272,-0.387 and-0.325(all P>0.05).6.During the mefication period of this trial,adverse reactions occurred in both groups of patients,and the safety indicators were obviously abnormal.Conclusion:In this study,the efficacy and safety of CGEC in patients with IBS-D were studied by observing IBS-SSS score,stool frequency,stool trait score,IBS-QOL quality of life score,SAS and SDS score and the conclusions are as follows:(1)CGEC significantly reduced the IBS-SSS score,defecation times and Bristol score of IBS-D patients.(2)CGEC significantly improved the life quality of patient and their level of anxiety and depression.(3)CGEC has the best curative effect on IBS-D patients with spleen deficiency and dampness excess syndrome,and has a curative effect on other syndrome types,but the result is not statistically meaningful,which may be related to the small sample size.(4)CGEC has good safety in the treatment of IBS-D. |
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