Clinical Observation Of Modified Zisheng Granules In The Treatment Of Diarrhea-predominant Irritable Bowel Syndrome With Splenic Deficiency And Hepatic Stagnation

Objective: The purpose of this study is to observe the clinical efficacy and safety of Modified Zisheng Granules on diarrhea-predominant irritable bowel syndrome(IBS-D)with splenic deficiency and hepatic stagnation.To explore the effect of Modified Zisheng Granules on visceral sensitivity,anorectal motility and sensory index,serum 5-hydroxytryptamine(5-HT)and inflammatory factors in IBS-D patients with splenic deficiency and hepatic stagnation.To reveal the possible mechanism of Modified Zisheng Granules.To provide objective basis for Modified Zisheng Granules to treat IBS-D of splenic deficiency and hepatic stagnation.Methods: 80 IBS-D patients with splenic deficiency and hepatic stagnation were randomly divided into control group and treatment group,40 cases in each group.The control group was treated with Trimebutine Maleate Capsule orally,while the treatment group was treated with Modified Zisheng Granules orally on the basis of the control group.Both groups were treated for 8 weeks.The clinical efficacy,the severity of clinical symptoms which include TCM symptom score,irritable bowel syndrome symptom severity Scale(IBS-SSS)scor,the visceral sensitivity which include visceral sensitivity index(VSI)scale scor,the anorectal motility index which include anal resting pressure(ARP),anal systolic pressure(ASP),anal maximal contraction pressure(AMCP),rectal resting pressure(RRP),inside rectal pressure(IRP),the anorectal sensory index which include initial sensory threshold,initial defecation impulse threshold and maximum tolerance capacity,the serum 5-HT levels,and the Serum inflammatory factor index which include interleukin(IL)-6,IL-8,tumor necrosis factor-alpha(TNF-?)levels and safety index were compared between the two groups before and after treatment.Results :1.Comparison of clinical effects: After treatment,the total clinical effective rate of the treatment group was 85.00%,significantly better than 62.50% of the control group,the difference was statistically significant(P<0.05).2.Comparison of TCM symptom score: There was no significant difference in total score of TCM symptoms between the two groups before treatment(P>0.05).After treatment,the total score of TCM symptoms in the two groups were lower than those before treatment(P<0.05).After treatment,the total score of TCM symptoms in the treatment group was significantly lower than those in the control group(P<0.05).3.Comparison of severity of clinical symptoms: There was no significant difference in the scores of IBS-SSS between the two groups before treatment(P>0.05).After treatment,the IBS-SSS scores of the two groups were lower than those before treatment,and the difference was statistically significant(P<0.05).After treatment,the IBS-SSS score of the treatment group was lower than that of the control group,and the difference was statistically significant(P<0.05).4.Visceral sensitivity comparison: There was no significant difference in VSI score between the two groups before treatment(P>0.05).After treatment,the VSI scores of the two groups were lower than those before treatment,and the difference was statistically significant(P<0.05).After treatment,the VSI scoreof the treatment group was lower than that of the control group,and the difference was statistically significant(P<0.05).5.Comparison of anorectal motility indexes: There was no significant difference in ARP,ASP,AMCP,RRP and IRP between the two groups before treatment(P>0.05).Compared with those before treatment,there was no significant difference in ARP,ASP,AMCP and RRP between the two groups after treatment(P>0.05).After treatment,the IRP of the two groups was higher than that before treatment,and the difference was statistically significant(P<0.05).After treatment,there was no significant difference in ARP,ASP,AMCP and RRP between the two groups(P>0.05).After treatment,the IRP of the treatment group was higher than that of the control group,and the difference was statistically significant(P<0.05).6.Comparison of anorectal sensory indexes: There was no significant difference in the initial sensory threshold,the initial defecation impulse threshold and the maximum tolerance capacity between the two groups before treatment(P>0.05).After treatment,the initial sensory threshold,the initial defecation impulse threshold and the maximum tolerance capacity of the two groups were higher than those before treatment,the difference was statistically significant(P< 0.05).After treatment,the initial sensory threshold,initial defecation impulse threshold and maximum tolerance capacity of patients in the treatment group were significantly higher than those in the control group(P<0.05).7.Comparison of serum 5-HT levels: There was no significant difference in serum 5-HT level between the two groups before treatment(P>0.05).After treatment,the serum 5-HT levels of the two groups were lower than those before treatment,and the difference was statistically significant(P<0.05).After treatment,the serum 5-HT levels in the treatment group was lowerthan that in the control group,and the difference was statistically significant(P<0.05).After treatment,the serum 5-HT levels in the treatment group was lower than that in the control group,and the difference was statistically significant(P<0.05).8.Comparison of serum inflammatory factors: There was no significant difference in the levels of IL-6,IL-8 and TNF-? between the two groups before and after treatment(P>0.05).After treatment,the serum levels of IL-6,IL-8 and TNF-? in the two groups were significantly lower than those before treatment(P<0.05).After treatment,the serum levels of IL-6,IL-8 and TNF-?in the treatment group were significantly lower than those in the control group(P<0.05).9.Safety comparison between the two groups: During the treatment,there was no significant adverse reactions in both groups.Conclusion:1.The clinical effect of Modified Zisheng Granules on IBS-D patients with splenic deficiency and hepatic stagnation is significant and safe.2.Modified Zisheng Granules can improve the TCM symptoms and severity of clinical symptoms in patients with IBS-D with splenic deficiency and hepatic stagnation.3.Modified Zisheng Granules can improve the anorectal motility index of IBS-D patients with splenic deficiency and hepatic stagnation.4.Modified Zisheng Granules can improve visceral sensitivity index,anorectal sensory index and serum 5-HT level of IBS-D patients with splenic deficiency and hepatic stagnation,so as to reduce visceral hypersensitivity of IBS-D patients.5.Modified Zisheng Granules can improve the level of serum inflammatory factors in IBS-D patients with splenic deficiency and hepatic stagnation,so asto reduce the inflammatory response of patients and protect the intestinal tissue.