A Controlled Study Of The Clinical Effects Of Duodongning Capsule, Topiramate And Aripiprazole In The Treatment Of Tic Disorders

Objective: To evaluate the efficacy and safety of Duodongning capsule, Topiamate and Aripiprazole in the treatment of children with tic disorders.Method: A prospective, randomized, open-label controlled clinical trial was conducted in 102 chiidren aged 4-14 years with chronic tic disorders or tourette syndrome. The patients were assigned to three groups: duodongning group(n=33) with the treatment dosage of 3.42-5.7g/d, topiramate group(n=35) with the treatment dosage of 2mg/(kg·d), aripiprazole group(n=34) with the treatment dosage of 5mg/d. After 12 weeks treatment, the clinical efficacy was assessed by the Yale Global Tic Severity Scale(YGTSS) Score, and adverse reaction were observed by side effects symptoms scale, routine blood indexes, blood biochemical indexes and weight.Result: Pre and post-trentment differences were ascertained for motor tic and total scores of YGTSS in the three groups from the second week of treatment(P<0.05), but no differences were ascertained for phonic tic and function damage of YGTSS in all groups from the second week of treatment(P>0.05). Pre and post-trentment differences were ascertained for motor tic, phonic tic, function danmage and total scores of YGTSS in the duodongning group and topiramate group from the fourth week of treatment(P<0.05); pre and post-trentment differences were ascertained for motor tic, function danmage and total scores of YGTSS in the aripiprazole group from the fourth week of treatment(P<0.01), but no differences were ascertained for phonic tic of YGTSS in aripiprazole group from the fourth week of treatment(P>0.05). Pre and post-trentment differences were ascertained for motor tic,phonic tic, function danmage and total scores of YGTSS in all groups from the eigthh and twelfth week of treatment(P<0.05). After 12 weeks treatment, total scores of YGTSS in the duodongning group descreased from(42.30±10.94) at baseline to(19.33±11.69), in the topiramate group from(43.66±9.46) to(19.40±14.69), and in the aripiprazole group from(43.03±14.51) to(17.29±12.69). The mean reduction scores of YGTSS were 22.97 in the duodongning group, 24.26 in the topiramate group and 25.74 in the aripiprazole group at the end of treatment. The clinical response rates 60.6%, 71.4% and 67.6 %, respectively. There were no significant differences in three groups(P>0.05). The incidence of adverse reactions was similar in the duodongning group, topiramate group and aripiprazole group, with 0%, 13.9% and 11.8% respectively. There were no significant differences in the incidence of adverse reactions in threes groups and no severe adverse events were found in three groups.Conclusion: The results showed that duodongning capsule and topiramate showed similar therapeutic effect to aripiprazole in the treatment of children with chronic tic disorders and Tourette syndrone. Duodongning capsule, topiramate and aripiprazole were safe and well tolerated in chinese population, and can be considered as valid and safe option for the treatment of tic disorders.