Clinical Observation Of Huoxiang Huazhuo Dedoction In Treating Diarrhea-predominant Irritable Bowel Syndrome With Spleen Deficiency And Dampness Excess Syndrome

Objective: The purpose of this study was to observe the clinical efficacy and safety of Huoxiang Huazhuo dedoction in the treatment of diarrheapredominant irritable bowel syndrome(IBS-D)with spleen deficiency and dampness excess syndrome,and to explore the characteristics and pharmacological effects of Huoxiang Huazhuo dedoction,in order to provide TCM clinical reference and broaden the treatment direction and thought for the treatment of IBS-D.Methods: 64 patients who met the diarrhea-predominant irritable bowel syndrome with spleen deficiency and dampness excess syndrome criteria were randomly divided into control group and treatment group,32 patients in each group.The treatment group was given oral Huoxiang Huazhuo dedoction 1 dose per day,which was divided into morning and evening to use on an empty stomach while warm.The control group was treated with pinaverium bromide tablets three times a day,50 mg each time,and swallow with three meals.Two groups were treated for four weeks.Two groups were recorded the data of TCM symptom scores,IBS-SSS scores,IBS-QOL scores and adverse reactions before and after treatment.Follow-up was conducted at the second week,the first month and the third month after the end of treatment.All data were analyzed by statistical software.Results:1.Overall efficacy comparison:There were 32 patients in the control group and 32 patients in the treatment group.According to the control group,3 patients were cured,5 cases had obviously effection,13 patients were effective and 11 cases had no effect,and the total effective rate was 65.62%.At the same time for the treatment group,7 patients were cured,13 patients had obviously effection,8 cases were effective and 4 cases were ineffective,the total effective rate of it was 87.5%.The overall efficacy of the two groups had significant difference(P<0.05).2.Total TCM symptoms score Comparison:There was no statistical difference in the total score of TCM symptoms between the two groups before treatment(P>0.05).The total score of TCM symptoms in the both two groups decreased after treatment(P<0.05),and the improvement of the total score of TCM symptoms in the treatment group was better than that in the control group significantly(P<0.01).3.Single TCM symptom score Comparison:There was no significant difference in the scores of each symptom between the two groups before treatment(P>0.05).After treatment,the main symptoms of abdominal pain,diarrhea,loose stool and secondary symptoms of poor appetite were improved in the control group(P<0.05),but there was no significant effect on secondary symptoms of fatigue and sleepiness,cold-food fear(P>0.05),while each symptom in the treatment group were significantly improved(P<0.05).There showed no significant difference between the two groups in improving abdominal pain after treatment(P>0.05),but the treatment group was better than the control group in improving the main symptoms of diarrhea(P<0.05),and the effect of treatment group was significantly superior to the control group in terms of the improvement on main symptoms of loose stool and secondary symptoms of fatigue and sleepiness,cold-food fear and poor appetite(P<0.01).4.IBS-SSS comparison:There was no significant difference in IBS-SSS score between the two groups before treatment(P>0.05).After treatment,The total scores of IBS-SSS in both two groups decreased(P<0.05),and the treatment group was superior to the control group(P<0.05).5.IBS-QOL comparison:There was no significant difference in life quality scores between the two groups before treatment(P>0.05).After treatment,The control group showed no significant improvement in the overall quality of life(P>0.05),while the treatment group could effectively improve it(P<0.05),and the effect was better than that of the control group(P<0.05).6.Recurrence rate comparison:After the course of treatment,patients whose curative effect index over 30% were followed up.There were 21 cases in the control group and 28 cases in the treatment group.After two weeks of treatment,3 cases recurred in the control group and the recurrence rate was 14.30%,1 case in the treatment group and the recurrence rate was 3.57%.Four weeks after treatment,8 cases relapsed in the control group,with a recurrence rate of 38.01%.3 cases relapsed in the treatment group,with a recurrence rate of 10.71%.Three months after treatment,there were a total of 16 cases relapsed in the treatment group,with a recurrence rate of 76.19%.And 8 cases relapsed in the control group,with a recurrence rate of 28.57%.The number of recurrence patients in the treatment group was less than that in the treatment group at the above stages(P<0.05).7.Safety comparison:During the time of treatment and follow-up,no adverse reactions occurred in either group.All vital signs and assistant examination showed no obvious abnormal changes.Conclusions:The overall efficacy of Huoxiang Huazhuo dedoction in the treatment of diarrhea-predominant irritable bowel syndrome with spleen deficiency and dampness excess syndrome is better than that of pinaverium bromide tablets alone.Huoxiang Huazhuo dedoction can significantly relief the patient’s abdominal pain,diarrhea,loose stool,cold-food fear,poor appetite and other clinical symptoms,reduce symptom severity,improve the quality of life from multiaspect and multidimension.At the same time,Huoxiang Huazhuo dedoction has an excellent short-term and long-term efficacy in this disease with a low recurrence rate.The overall medication is safe and reliable,which is worthy of further clinical research,application and promotion.