RESUMO
Objective To evaluate the efficacy and safety of Choudongning (CDN) Capsule in children with Tourette’s syndrome of spleen deficiency and phlegm accumulation. Methods A stratified-block randomized, parallel-controlled, double-blind, double- dummy, multi-center trials were designed for clinical study. A total of 240 patients were enrolled and separated randomly into experimental group and positive control group in the rate of 1:1. Patients in the experimental group orally took CDN Capsule and simulated Tiapridal Tablets; The patients in positive control group took Tiapridal Tablets and simulated CDN Capsule. Treatment course lasted for 6 weeks. The clinical efficacy and integrals of YGTSS twitch, the factor scores of motor tics and vocal tics, YGTSS social function damage, traditional Chinese medicine syndrome efficacy were observed to evaluate its security. Results The total effective rate of YGTSS twitch clinical efficacy was 71.19% in the experimental group and 67.50% in the positive control group, respectively. The results of non-inferiority test indicated that the efficacy of experimental group was not worse than that in the positive control group. There was no significant difference between two groups in YGTSS twitch integrals, motor tics and vocal tics’ factor scores, YGTSS social function damage, and traditional Chinese medicine syndrome efficacy. Only two ADRs (1.67%) in the experimental group and six ADRs (5%) in the positive control group were observed during clinical trials. The incidence of ADRs in the experimental group was lower than that in the positive control group with no statistical difference. Conclusion CDN Capsule have similar efficacy on the treatment of Tourette’s syndrome of spleen deficiency and phlegm accumulation contrast to Tiapridal Tablets, with lower adverse reactions and better safety.