TY - JOUR
T1 - Efficacy of the Jingxin Zhidong Formula for Tic Disorders
T2 - A Randomized, Double Blind, Double Dummy, Parallel Controlled Trial
AU - Fan, Fei
AU - Hao, Long
AU - Zhang, Si
AU - Zhang, Ying
AU - Bian, Zhaoxiang
AU - Zhang, Xuan
AU - Wang, Qiong
AU - Han, Fei
N1 - Funding Information:
This study was supported by the institute-level project of the China Academy of Chinese Medical Sciences.
Publisher Copyright:
© 2022 Fan et al.
PY - 2022/1
Y1 - 2022/1
N2 - BackgroundThe Jingxin Zhidong formula (JXZDF), a traditional Chinese medicine, has been widely used to treat tic disorder (TD) in China. However, its efficacy has not yet been evaluated in a randomized controlled trial. We aimed to compare the effectiveness and safety of JXZDF and aripiprazole in patients with TD. MethodsIn this randomized, double-blind, double-dummy, parallel controlled trial, 120 patients with TD, aged 6–16 years were randomly assigned to receive either JXZDF (n = 60, 17.6 g/day) or aripiprazole (n = 60, 10 mg/day) for 12 weeks. The primary outcome was measured using the Yale Global Tic Severity Scale (YGTSS). Adverse events were assessed using the Treatment Emergent Symptom Scale. ResultsJXZDF produced greater improvements than aripiprazole in the following YGTSS subscale scores at the endpoint: total tic scores (P = 0.004, 95% CI: 1.085–3.494) and total motor scores (P = 0.004, 95% CI: 0.313–1.739). The difference in rate between the groups was no significant (χ2 = 0.702, degrees of freedom = 1, P = 0.402). The overall incidence of adverse events was significantly lower in the JXZDF group than in the aripiprazole group (0% vs 6.67%, P < 0.001). ConclusionJXZDF had a better safety profile than aripiprazole, and it was not inferior in terms of clinical efficacy. JXZDF warrants consideration as a potential treatment option for TD.
AB - BackgroundThe Jingxin Zhidong formula (JXZDF), a traditional Chinese medicine, has been widely used to treat tic disorder (TD) in China. However, its efficacy has not yet been evaluated in a randomized controlled trial. We aimed to compare the effectiveness and safety of JXZDF and aripiprazole in patients with TD. MethodsIn this randomized, double-blind, double-dummy, parallel controlled trial, 120 patients with TD, aged 6–16 years were randomly assigned to receive either JXZDF (n = 60, 17.6 g/day) or aripiprazole (n = 60, 10 mg/day) for 12 weeks. The primary outcome was measured using the Yale Global Tic Severity Scale (YGTSS). Adverse events were assessed using the Treatment Emergent Symptom Scale. ResultsJXZDF produced greater improvements than aripiprazole in the following YGTSS subscale scores at the endpoint: total tic scores (P = 0.004, 95% CI: 1.085–3.494) and total motor scores (P = 0.004, 95% CI: 0.313–1.739). The difference in rate between the groups was no significant (χ2 = 0.702, degrees of freedom = 1, P = 0.402). The overall incidence of adverse events was significantly lower in the JXZDF group than in the aripiprazole group (0% vs 6.67%, P < 0.001). ConclusionJXZDF had a better safety profile than aripiprazole, and it was not inferior in terms of clinical efficacy. JXZDF warrants consideration as a potential treatment option for TD.
KW - Chinese herbal Medicine formula
KW - Jingxin Zhidong formula
KW - Randomized controlled trial
KW - Tic disorder
KW - Tourette syndrome
UR - http://www.scopus.com/inward/record.url?scp=85124382015&partnerID=8YFLogxK
U2 - 10.2147/NDT.S347432
DO - 10.2147/NDT.S347432
M3 - Journal article
AN - SCOPUS:85124382015
SN - 1176-6328
VL - 18
SP - 57
EP - 66
JO - Neuropsychiatric Disease and Treatment
JF - Neuropsychiatric Disease and Treatment
ER -