- 2022-01-11
- Neuropsychiatric disease and treatment 18
Study Design
- Type
- Clinical Trial
- Sample size
- n = 120
- Population
- 120 patients with TD, aged 6–16 years
- Methods
- Randomized, double-blind, double-dummy, parallel controlled trial; JXZDF (17.6 g/day) or aripiprazole (10 mg/day) for 12 weeks
- Blinding
- Double-blind
- Duration
- 12 weeks
- Funding
- Unclear
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).