[A multi-center randomized double-blinded, placebo-controlled clinical study on efficacy of composite sophora colon-soluble capsules in treating ulcerative colitis of internal dampness-heat accumulation syndrome type].

ABSTRACT

OBJECTIVE: To evaluate the clinical efficacy and safety of Composite Sophora Colon-soluble Capsules (CSCC) in treating patients with ulcerative colitis (UC) of internal dampness-heat syndrome type (IDHS) and compared with that of Mesalazine slow releasing granules (trade name Etiasa). METHODS: Adopting randomized double-blinded double-simulated and positive drug controlled clinical design, 160 patients with UC of IDHS type were randomly assigned to two groups, 120 in the trial group was treated with CSCC plus Etiasa simulated placebo for 8 weeks, while 40 in the control group with Etiasa plus CSCC simulated placebo. Comprehensive therapeutic efficacy, effects on syndrome and safety of treatment were assessed, and changes of endoscopic features, Chinese medical syndrome scores and symptom score, activity index (AI) of UC, microscopic pathology in the two groups were observed and compared before and after treatment. RESULTS: After 8-week treatment, the clinical total effective rate in the two groups were 92.0% and 83.3%, the effective rate on Chinese medical syndrome in them were 91.7% and 85.0%, that on endoscopic features 92.0% and 83.3%, on microscopic changes 66.7% and 52.0%, respectively, showing insignificant difference between groups. Difference between groups in AI also showed no significance (1.03 +/- 1.87 vs 1.78 +/- 2.18, P > 0.05). However, the effects of decreasing Chinese medical syndrome score, and improving mucous pus blood stool and foul defecation in the trial group were more significantly (P < 0.05). No serious adverse event was seen in the 8-week treatment period. CONCLUSIONS: The clinical efficacy of CSCC was not inferior to, or even better than that of Etiasa. It could be taken as a substitute of chemicals if with poor effect.