| Objective:To observe the clinical effect of Jiajian Simo decoction on chronic constipation of stagnation of QI.Method:95 patients with CC were divided randomly into such two groups as A Group (Jiajian Simo decoction group,47 cases) and B Group (prucalopride group,48 cases). The patients in A Group took 50 ml Jiajian Simo decoction each time within 30 minutes before each of three daily meals, 3 times a day; While the patients in B Group took 2 mg prucalopride each time,1 time a day; Four weeks was recognized as a course of treatment for the two groups. Observation time of 3 periods of treatment. The efficacy end points were the proportion of patients who had three or more spontaneous complete bowel movements (SCBM) per week, averaged over 12 weeks, as well as an increase in the number of SCBM of one or more. Meanwhile, adverse events were monitored.Results:On the primary end point, Jiajian Simo decoction was significantly more effective than prucalopride with 20 (42.55%) vs 14 (29.17%) patients having a weekly average of≥ 3 SCBMs during the 12-week treatment (P=0.013) (Pamp;it;0.05 for both comparisons); Respective percentages were 61.70%(A group) vs 43.75%(B group) of patients who had an increase in the number of SCBMs of one or more per week on average, (P=0.004). By comparing the patient assessment of constipation quality of life (PAC-QOL) questionnaire at baseline and at weeks 4,6 and 12, Jiajian Simo decoction significantly improved the disease-related quality of life in patients with CCSQ, which was superior than prucalopride. The most frequent adverse events were nausea, headache, diarrhea and abdominal pain. There were no significant cardiovascular effects of treatment.Conclusion:Jiajian Simo decoction has more effective in treatment of CCSQ than prucalopride. Jiajian Simo decoction significantly improved the disease-related quality of life in patients with CCSQ, which was superior than prucalopride. The security of Simo decoction was significantly higher than prucalopride. |
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