A proprietary herbal medicine (5‐ L ing G ranule) for T ourette syndrome: a randomized controlled trial

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‐ LG r), 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‐ LG r ( 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‐ LG r 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‐ LG r 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‐ LG r 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‐ LG r is comparable to tiapride in reducing tics. Its safety profile is better than tiapride. 5‐ LG r can be considered a safe and effective therapy for TS (Trial registration: www.clinicaltrials.gov : NCT 01501695).