Background: 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