Abstract
OBJECTIVE: We designed this study to verify the clinical efficacy and safety of Shaomazhijing granules, a Chinese patent medicine, in the treatment of Tourette's syndrome (TS) with liver-yang hyperactivity, liver wind, and phlegm-fire disturbance. METHODS: We enrolled a total of 603 children and adolescents aged 5-18 years with TS in this randomized, double-blinded, multicenter study. We randomly assigned participants to a Shaomazhijing granules group, a Tiapride group, or a placebo group in a ratio of approximately 3:1:1, respectively. We evaluated the treatment results using the traditional Chinese medicine (TCM) syndrome quantitative classification scale and also compared the incidence of adverse events among the three groups. RESULTS: The TCM syndrome of all patients improved over time. At week eight of TCM treatment, the overall syndrome score, primary symptoms (muscle tics), and secondary symptoms (emotional and psychological) of patients in the Shaomazhijing granules and tiapride groups showed significant improvements when compared to that of patients in the placebo group. Compared with the tiapride group, the Shaomazhijing granules group showed better improvement in the secondary symptoms (P < 0.05). While the clinical efficacy for primary symptoms of patients in the Shaomazhijing granules was similar (P = 0.969) with that of patients in tiapride groups. The TCM syndrome clinical control rate and the clinically excellent effectiveness rate of the Shaomazhijing granules group (3.45% and 44.51%) and tiapride group (2.86% and 26.67%) were higher than that of the patients in placebo group (1.04% and 12.50%, P < 0.001). Patients in placebo group (11.2%) and Shaomazhijing granules group (13.8%) had significantly lower overall adverse event rates in comparison with those in tiapride group (26.8%, P = 0.002). CONCLUSION: The clinical efficacy of Shaomazhijing granules is comparable to tiapride in reducing reducing the primary symptoms (muscle tics) of TS. Besides, it showed better efficacy in improving secondary (emotional and psychological) symptoms. Its safety profile is better than tiapride. Based on these results, Shaomazhijing granules can be considered a safe and effective treatment for patients with TS.