Objective: To observe the clinical efficacy and expound the basis of pr escription decision of Mahuang Fuzi Xixin decoction(MFX decoction)combined with Lizhong decoction in treating the type Yang deficiency of spleen and renal in diarrhea-predominant irritable bowel syndrome(IB S-D).Meanwhile illuminate the traditional Chinese medicine(TCM)pat hogenesis of IBS-D,providing some novel therapeutic visions and direct ions for the clinic.Methods: 62 IBS-D patients of the type Yang deficiency of spleen and renal were included in this research,divided randomly into the treatment group and the control group according to the principle of random allocation.1 patient was withdraw in each group and 30 patients finally completed the process in both groups.The control group was given oral trimebutine maleate capsules,0.2g each time,3 times daily after meals.In the treatment group,MFX decoction combined with Lizhong decoction were introduced,1 dose per day,which divided equally and taken mixed with boiled water in the morning and at night.The research process lasted for 4 weeks,weekly follow-up visit was needed for every patient.According to the level of improvement in symptoms,the dose could be adjusted by the researchers.Both before and after the research,TCM symptom scores,clinical efficacy,IBS-SSS scale,IBS-QOLscale,safety and recurrence rate were evaluated.The subjects were followed up at 4 weeks,6 weeks and 8 weeks after the treatment to observe the recurrence.Data obtained was analyzed using statistics analysis by SPSS 22.0software.Results: After the therapy,the treatment group with the overall effective rate of 86.7% showed significantly higher compared with the control group,which the rate only was 63.3%(P < 0.05).The total TCM symptom scores of both groups was lower than that in the beginning of the therapy(P< 0.05),while the treatment group showed better remission(P< 0.01).Every single symptom score of the treatment group was significantly improved,especially on the item of abdominal pain,loose stool,cold limbs,and soreness and weakness of waist and knees(P < 0.01).Nevertheless,only the main symptoms of abdominal pain,abdominal distention,loose stool,and secondary symptoms of poor appetite and fatigue were improved(P < 0.05).The treatment group also received more pronounced reduced scores in the IBS-SSS scale and IBS-QOL scale,with statistical difference(P < 0.01).Follow-up data suggested that the recurrence rate was similar in both groups at 2weeks after therapy(3.8% v.s.15.8%,P>0.05),but the treatment group showed significantly lower recurrence rate than the control group at 4weeks(11.5% v.s.36.8%,P<0.05)and 6 weeks(19.2% v.s.47.4%,P<0.05)after therapy.Besides,there was no statistically significant difference in safety indicators between both groups(P > 0.05).Conclusion:The above results suggested that MFX decoction combined with Lizhong decoction showed more effective than trimebutine maleate capsules in the therapy of the type Yang deficiency of spleen and renal in IBS-D patients.It proved the advantages of TCM combined with dialectical theory in the treatment of this very disease and improved the quality of patients' dailylife.Further studies were needed to been carried out and promoted in clinical practice. |