Objective: This research adopts randomized controlled clinical research methods,with shuangbaitongxie capsule treat the irritable bowel syndrome type diarrhea ofstagnation of liver qi and spleen deficiency,observe the clinical efficacy and safety.Methods:72cases of patients with irritable bowel syndrome type diarrhea ofstagnation of liver qi and spleen deficiency,with randomized controlled trial method,divided into treatment group and control group with36cases in each group, thetreatment group taking shuangbaitongxie capsule, the control group was givenchangweining tablets, after7days of treatment, observe the Chinese medicinesymptom integral decrease and the change of the laboratory examination indexes,objective evaluation the efficacy and safety of shuangbaitongxie capsule.Results:(1) Basic information: the treatment group and the control group patient’sstatistical results such as the age, course of disease, time of onset, the primarysymptom integral, and secondary symptom scores integral had no statisticalsignificance (P>0.05).(2) TCM syndromes: after the trial, treatment group and controlgroup could significantly improve the symptoms of patients with total integral(P<0.01), the treatment group’s total integral decreased more than the control group(P<0.01). The primary symptom integral: two group’s primary symptom integral asabdominal pain, diarrhea were significantly reduced (P<0.01), the treatment groupreduced more than that of the control group (P<0.01). The secondary symptom integral: two group’s secondary integral as chest and ateral thorax turgor or reducingdiet were significantly reduced (P<0.01).the treatment group reduced more than thatof the control group (P<0.01).(3) The overall effect: through7days of clinicalobservation, respectively,96.88%and87.88%of the total efficiency of the treatmentgroup and the control group, the overall effect of treatment group is better than thecontrol group (P<0.01).(4) Safety: the treatment group was treated withshuangbaitongxie capsule for7days, the liver and kidney function, blood routine,urine routine, and stool routine values were in the normal range, there was nosignificant difference (P>0.05).Conclusion: Shuangbaitongxie capsule in treating irritable bowel syndrome typediarrhea of stagnation of liver qi and spleen deficiency can significantly improve theclinical symptoms, and no obvious side effect, the safety is good. |