BACKGROUND: @entity4676 ( @entity4676 ) is a common @entity1765 in @entity1 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 @entity1 with @entity4676 in comparison with @entity38857 and placebo. METHODS: In this multisite, double-blind, double-dummy, randomized, placebo-controlled trial, 603 @entity1 with @entity4676 aged 5-18  years were randomly assigned to treatment with placebo (n  =  117), @entity38857 (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 @entity1765 . Incidence of adverse events was compared among the three groups. RESULTS: While tics of all @entity1 were reduced over time, 5-LGr and @entity38857 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 @entity1 in the 5-LGr arm and 68.3% in the @entity38857 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 @entity1 on placebo and 5-LGr compared to @entity38857 (11.2% and 13.8% vs. 26.0%, p  =  .002); in particular physical tiredness, @entity1296 and @entity25 . CONCLUSIONS: The clinical efficacy of 5-LGr is comparable to @entity38857 in reducing tics. Its safety profile is better than @entity38857 . 5-LGr can be considered a safe and effective therapy for @entity4676 (Trial registration: www.clinicaltrials.gov: NCT01501695).

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

@entity1 :: ('9606', 'Species') :: ['children', 'patients'] @entity38857 :: ('MESH:D063325', 'Chemical') :: ['tiapride'] @entity1765 :: ('MESH:D013981', 'Disease') :: ['tic disorder', 'tic-related impairment'] @entity1296 :: ('MESH:D004244', 'Disease') :: ['dizziness'] @entity25 :: ('MESH:D012893', 'Disease') :: ['sleep disturbance'] @entity4676 :: ('MESH:D005879', 'Disease') :: ['TS', 'Tourette syndrome']
@entity4676 :: (MESH:D005879,Disease) :: ['Tourette syndrome']
