Clinical Observation On Self-made Shugan Jianpi Dedoction In Treating Diarrhea-predominant Irritable Bowel Syndrome With Syndrome Of Liver Depression And Spleen Deficiency

Objective: The purpose of this study is to observe the clinical efficacy and safety of the self-made Shugan Jianpi dedoction in treating diarrhea-predominant Irritable Bowel Syndrome(IBS-D)with syndrome of liver depression and spleen deficiency,and to explore the characteristics and modern pharmacology of the prescription.We want to provide new drugs for the treatment of IBS-D with traditional Chinese medicine.Methods: 60 patients who met the IBS-D with syndrome of liver depression and spleen deficiency were randomly divided into control group and treatment group,30 patients in each group.The treatment group was given oral Shugan Jianpi dedoction 1 dose per day,which was divided into morning and evening to use while warm after dinner.The control group was treated with Trimebutine Maleate Capsule combined with Bacillus Licheniformis Capsules three times a day before dinner,one dose for 0.1g and the other for 0.5g.Two groups were treated for 2 months.They were recorded the data of adverse reactions,TCM symptom scores,IBS-SSS scores,SAS and SDS scores before and after treatment.Statistical analysis of the results was carried out by software.Results: There were 2 cases of abscission.A total of 58 cases participated in the final statistics,29 cases in the treatment group and 29 cases in the control group.1.Single TCM symptom score: The symptoms in treatment group had significant difference in statistics than those before the experiment which showed improvement after treatment(P<0.05).As for the control group,the symptoms also showed improvement after treatment expect of belching(P>0.05).In symptom score of abdominal distension and abdominal pain,irritability,fatigue,hypochondrium distention,loss of appetite and belching,the treatment group improved more significantly than the control group(P<0.05).However,there was no significant difference between the two groups about the symptom of diarrhea and borborygmus,and the treatment group was not superior to the control group.2.Total score of TCM symptoms score and overall efficacy: There were significant differences in total score of TCM symptoms between the treatment group and the control group before and after treatment(P<0.05).It showed that both groups improved after treatment.There were statistical differences in the total symptom score between two groups(P<0.05).And this showed that in the overall improvement the treatment group was much more significant.As for overall efficacy,the total effective rate of the control group was 51.72%,and that of the treatment group was 86.21%.It can be concluded that the effective rate of control group is lower than treatment group.3.IBS-SSS score: There were significant differences in IBS-SSS score between the treatment group and the control group before and after treatment(P<0.05).It showed that both groups improved after treatment.The treatment group and the control group also had the statistical difference after treatment(P<0.05).The results showed that the improvement of IBS-SSS score in the treatment group was better than that in the control group.4.SAS and SDS score:There were significant differences in SAS and SDS scores between the treatment group and the control group before and after treatment(P<0.05).It showed that both groups improved after treatment.Both groups also had the statistical difference after treatment(P<0.05).The results showed that the improvement of SAS and SDS scores in the treatment group were better than that in the control group.5.Safety comparison: There were no obvious abnormality in vital signs and other assistant examinations during the time of treatment which means that both groups of drugs could be used in the clinic.Conclusion: The overall efficacy of self-made Shugan Jianpi dedoction in the treatment of IBS-D with syndrome of liver depression and spleen deficiency is better than that of Trimebutine Maleate Capsule combined with Bacillus Licheniformis Capsules.The self-made Shugan Jianpi dedoction can significantly relief the patient’s clinical symptoms,reduce symptom severity.No adverse reactions and side effects were found in clinical medication,which can be further studied and applied in clinical practice.