Neuropsychiatric Disease and Treatment (Jan 2022)
Efficacy of the Jingxin Zhidong Formula for Tic Disorders: A Randomized, Double Blind, Double Dummy, Parallel Controlled Trial
Abstract
Fei Fan,1 Long Hao,2 Si Zhang,1 Ying Zhang,3 Zhaoxiang Bian,4 Xuan Zhang,4 Qiong Wang,5 Fei Han1 1Department of Paediatrics, Guang’anmen Hospital, China Academy of Chinese Medical Sciences, Beijing, People’s Republic of China; 2Department of Paediatrics, Beijing Fangshan District Liangxiang Hospital, Beijing, People’s Republic of China; 3Centre for Evidence-Based Chinese Medicine, Beijing University of Chinese Medicine, Beijing, People’s Republic of China; 4Chinese EQUATOR Centre, Hong Kong Chinese Medicine Clinical Study Centre, Chinese Clinical Trial Registry (Hong Kong), School of Chinese Medicine, Hong Kong Baptist University, Kowloon, Hong Kong, People’s Republic of China; 5Clinical Medical School, Beijing University of Chinese Medicine, Beijing, People’s Republic of ChinaCorrespondence: Fei HanDepartment of Paediatrics, Guang’anmen Hospital, China Academy of Chinese Medical Sciences, No. 5, Beixiange Road, Xicheng District, Beijing, 100053, People’s Republic of ChinaTel +86 10-8800 1128Email [email protected]: The 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.Methods: In 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.Results: JXZDF 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).Conclusion: JXZDF 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.Trial Registration: CHiCTR, ChiCTR2000039601 (Registered November 2, 2020).Keywords: tic disorder, Tourette syndrome, Chinese herbal Medicine formula, randomized controlled trial, Jingxin Zhidong formula
