Efficacy of the Jingxin Zhidong Formula for Tic Disorders: A Randomized, Double Blind, Double Dummy, Parallel Controlled Trial

Abstract

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 (χ 2 = 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).

Mechanisms of Action of Semen Ziziphi spinosae in the Treatment of Tourette Syndrome

“… 15 , 16 SZR had also been used in a randomized, double blind, double dummy, parallel controlled trial with TS children. 17 Further studies could be designed to subsequent cell and animal experiments to reveal the underlying pharmacological and therapeutic effects of SZR for the treatment of TS.…”

“…32 SZR is a Chinese herbal medicine that has been widely used in sedatives and tranquilizers in traditional clinics. 17 Based on the current clinical and experimental research status of SZR treatment for TS, the present study further explored the mechanism of action of SZR by using a systems biology approach. In this study, SZR was found to have 10 compounds and 42 non-repeating targets.…”

“… 16 Although previous research has shown that SZR may play an important role in clinical TS treatment, the underlying mechanism is still unclear. 17 Therefore, in this study, systems biology approaches were used to screen the active compounds of SZR, identify its target genes, and explore the potential molecular mechanism of its therapeutic anti-tic effect.…”

“…15,16 SZR had also been used in a randomized, double blind, double dummy, parallel controlled trial with TS children. 17…”

Treatment of Tourette syndrome by acupuncture combined with Chinese medicine based on syndrome differentiation: A review

“…Fan et al [59] designed a randomized controlled trial to explore the clinical efficacy and safety of JXZDF in the treatment of TS. JXZDF is composed of the following drugs: Zhenzhumu (Concha Margaritifera), calcined Longgu (Os Draconis), Muli (Concha Ostreae), Suan zao ren (Semen Ziziphi Spinosae), Baiziren (Semen Platycladi), Baishao (Radix Paeoniae Alba), Jiangcan (Bombyx Batryticatus), Chaihu (Radix Bupleuri), www.md-journal.com Niubangzi (Fructus Arctii), Zhiqiao (Fructus Aurantii), Dilong (Lumbricus), Chantui (Periostracum Cicadae), and Baizhi (Angelica Dahurica).…”