A proprietary herbal medicine (5-Ling Granule) for Tourette syndrome: a randomized controlled trial.

Author(s): Zheng Y(1), Zhang ZJ(1,)(2), Han XM(3), Ding Y(4), Chen YY(5), Wang XF(6), Wei XW(7), Wang MJ(8), Cheng Y(9), Nie ZH(10), Zhao M(10), Zheng XX(11).

Affiliation(s): Author information: (1)Beijing Institutes for Brain Disorders, Beijing Anding Hospital, Capital Medical University, Beijing, China. (2)School of Chinese Medicine, LKS Faculty of Medicine, The University of Hong Kong, Hong Kong, China. (3)Department of Pediatrics, The Affiliated Hospital of Nanjing University of Chinese Medicine, Nanjing, Jiangsu, China. (4)Department of Pediatrics, The First Affiliated Hospital of Henan University of Chinese Medicine, Zhengzhou, Henan, China. (5)Department of Pediatrics, The First Affiliated Hospital of Zhejiang University of Chinese Medicine, Hangzhou, Zhejiang, China. (6)Department of Pediatrics, The Affiliated Hospital of Liaoning University of Chinese Medicine, Shenyang, Liaoning, China. (7)Department of Pediatrics, The First Affiliated Hospital of Tianjin University of Chinese Medicine, Tianjin, China. (8)Department of Pediatrics, Nanjing Brain Hospital Affiliated to Nanjing Medical University, Nanjing, Jiangsu, China. (9)Department of Pediatrics, The Second Affiliated Hospital of Tianjin University of Chinese Medicine, Tianjin, China. (10)Tasly Pharmaceutical Company, Tianjin, China. (11)Department of Internal Medicine, Peking Union Medical College (PUMC) Hospital, Chinese Academy of Medical Sciences, Beijing, China.

Publication date & source: 2015, J Child Psychol Psychiatry. ,

BACKGROUND: Tourette syndrome (TS) is a common tic disorder in children and adolescents. There is preliminary evidence that herbal medicine may possess the potential to treat tics. The purpose of this study was to formally evaluate the efficacy and safety of 5-Ling Granule (5-LGr), a proprietary polyherbal product, for the treatment of patients with TS in comparison with tiapride and placebo. METHODS: In this multisite, double-blind, double-dummy, randomized, placebo-controlled trial, 603 patients with TS aged 5-18 years were randomly assigned to treatment with placebo (n = 117), tiapride (n = 123, 200-400 mg/day) or 5-LGr (n = 363, 15-22.5 g/day) for 8 weeks. The primary outcome was measured using the Yale Global Tic Severity Scale (YGTSS) and its subscales, total tic Score (TTS) and tic-related impairment. Incidence of adverse events was compared among the three groups. RESULTS: While tics of all patients were reduced over time, 5-LGr and tiapride treatment produced significantly greater improvement on the YGTSS overall scale and subscale for TTS and impairment at endpoint than the placebo. Seventy-four percentage of patients in the 5-LGr arm and 68.3% in the tiapride arm had clinical response and these rates of response were significantly higher than those on placebo (44.0%, p < .001). The incidence of overall adverse events was significantly fewer for patients on placebo and 5-LGr compared to tiapride (11.2% and 13.8% vs. 26.0%, p = .002); in particular physical tiredness, dizziness and sleep disturbance. CONCLUSIONS: The clinical efficacy of 5-LGr is comparable to tiapride in reducing tics. Its safety profile is better than tiapride. 5-LGr can be considered a safe and effective therapy for TS (Trial registration: www.clinicaltrials.gov: NCT01501695).