| Purpose This study was designed to observe the different syndromes of traditional Chinese medicine granules treatment of diarrhea type irritable bowel syndrome treatment,compared with placebo and positive drug,and objective evaluation of Chinese medicine granules for treating diarrhea predominant clinical efficacy and safety of irritable bowel syndrome,and through the determination of serum 5-HT,D-content of xylose and the scientific study of Chinese medicine granules for treating diarrhea type of irritable bowel syndrome.Method During the period from September 2014 to November 2016 from a hospital in Wuhan city to collect with IBS-D included 72 cases of patients with standard.According to the randomized,double blind grouping principle is divided into 3 groups,respectively as the experimental group(36 cases),control group 1(18 cases)and control group 2(18 cases),two groups before each of the subjects must be a colonoscopy results in the past 6 months,no separate colonoscopy before and after treatment.All subjects were all a security check(three conventional,liver and kidney function,ECG),and serum 5-HT and D-content of xylose.The test group according to the liver stagnation and spleen deficiency dampness due to spleen deficiency,spleen kidney yang deficiency syndrome were treated with diarrhea I,diarrhea II,diarrhea III Trimebutine Maleate Capsules a placebo,control group 1 participants were given the Chinese medicine granule placebo and placebo,control group 2 Trimebutine Maleate Capsules,Trimebutine Maleate Capsules and two subjects were given the Chinese medicine granule placebo treatment for 8 weeks,after the end of treatment to meet the requirements to enter the 8 week follow-up.According to irritable bowel syndrome symptoms severe score(IBS-SSS)scores,irritable bowel syndrome,quality of life(IBS-QOL)scores,PRO scores,statistical results of TCM symptom score to evaluate the traditional Chinese medicine granule treatment,according to follow-up,the long-term curative effect evaluation of traditional Chinese medicine granules,and through the detection of plasma 5-HT,D-content of xylose on Chinese medicine granule Scientific agent for the treatment of diarrhea predominant irritable bowel syndrome.Results 1、The overall curative effect comparison: the experimental group total effective rate was 73.53%;control group 1 the total effective rate was 37.50%;control group 2 the total effective rate was 70.59%.the test group and the control group 2 overall efficiency comparison,no statistically significant difference(P > 0.05),the control group and the rest 1 overall efficiency of the two groups were compared.The difference(P < 0.05).2、After treatment,the experimental group and the control group 2 IBS symptom severity score compared with before treatment were decreased,the difference was statistically significant(P <0.05,P < 0.05),were compared between the two groups,no statistically significant difference(P > 0.05).The control group 1 after treatment score before treatment had no obvious change,no significant difference(P > 0.05),there was significant difference compared with the other two groups(P < 0.05,P < 0.05).3、After treatment in experimental group and control group o 2 IBS-QOL scores compared with before treatment were decreased,the difference was statistically significant(P < 0.05.P < 0.05),were compared between the two groups,no statistically significant difference(P > 0.05),control group 2 compared with before treatment had no obvious change,no significant difference(P > 0.05),and the other two groups,there was significant difference(P < 0.05,P < 0.05).4、After treatment in experimental group and control group 2 PRO scores compared with before treatment were decreased,the difference was statistically significant(P < 0.05,P < 0.05),were compared between the two groups,no statistically significant difference(P > 0.05),control group 1 compared with before treatment had no obvious change,the difference was not statistically significant(P > 0.05),and the other two groups,there was significant difference(P < 0.05,P < 0.05).5、After treatment in experimental group and control group 2 TCM symptoms score and treatment were all lower than before,the difference was statistically significant(P < 0.05,P < 0.05),were compared between the two groups,the test group decreased higher than the control group 2,a statistically significant difference(P < 0.05),control group 1 compared with before treatment,TCM symptom scores did not change significantly,the difference was not statistically significant(P > 0.05),there was significant difference compared with the other two groups(P < 0.05,P < 0.05).6、Comparison of serum 5-HT and D-xylose levels before and after treatment: before treatment,serum 5-HT,D-xylose content between the groups,no significant difference(P > 0.05),comparable.The experimental group and the control group 2 after treatment,serum 5-HT content decreased,the difference was statistically significant(P < 0.05,P < 0.05),were compared between the two groups,no statistically significant difference(P > 0.05),the control group was decreased 1 after treatment,serum 5-HT content,there was no statistically significant difference(P > 0.05),there is a statistically significant difference compared with the other two groups(P < 0.01,P < 0.01).7、Recurrence after treatment: 8 weeks follow-up,the recurrence rate of the experimental group was 28%,lower than that of the control group 2(66.7%),and the difference between the two groups(P < 0.05)was significant.Conclusions This study shows that the treatment effect of different syndromes of traditional Chinese medicine granules and Trimebutine Maleate Capsules IBS-D patients have a certain therapeutic effect,and almost.Traditional Chinese medicine granules and Trimebutine Maleate Capsules can be reduced in patients with IBS-SSS,IBS-QOL,PRO scores,improve the quality of life of patients,improve the IBS-D related symptoms of traditional Chinese medicine granules and Trimebutine Maleate Capsules can reduce the patients with symptoms of TCM,but Chinese medicine granule in improving TCM symptoms is better than Trimebutine Maleate Capsules.Traditional Chinese medicine granules and Trimebutine Maleate Capsules can reduce the content of 5-HT in serum,both quite effect,traditional Chinese medicine granules and Trimebutine Maleate Capsules can be significantly elevated 1H serum D-xylose content,improveintestinal absorption,but the traditional Chinese medicine granule is better than Trimebutine Maleate Capsules.Chinese medicine granule for treatment of IBS-D follow-up recurrence rate was lower than that of Trimebutine Maleate Capsules,good long-term effect. |
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