[article]
| Titre : |
A proprietary herbal medicine (5-Ling Granule) for Tourette syndrome: a randomized controlled trial |
| Type de document : |
Texte imprimé et/ou numérique |
| Auteurs : |
Yi ZHENG, Auteur ; Zhang-Jin ZHANG, Auteur ; Xin-Min HAN, Auteur ; Ying DING, Auteur ; Yu-Yan CHEN, Auteur ; Xue-Feng WANG, Auteur ; Xiao-Wei WEI, Auteur ; Min-Jie WANG, Auteur ; Yan CHENG, Auteur ; Zhao-Hong NIE, Auteur ; Min ZHAO, Auteur ; Xi-Xi ZHENG, Auteur |
| Article en page(s) : |
p.74-83 |
| Langues : |
Anglais (eng) |
| Mots-clés : |
Tourette syndrome tics herbal medicine tiapride 5-Ling Granule |
| Index. décimale : |
PER Périodiques |
| Résumé : |
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). |
| En ligne : |
http://dx.doi.org/10.1111/jcpp.12432 |
| Permalink : |
https://www.cra-rhone-alpes.org/cid/opac_css/index.php?lvl=notice_display&id=273 |
in Journal of Child Psychology and Psychiatry > 57-1 (January 2016) . - p.74-83
[article] A proprietary herbal medicine (5-Ling Granule) for Tourette syndrome: a randomized controlled trial [Texte imprimé et/ou numérique] / Yi ZHENG, Auteur ; Zhang-Jin ZHANG, Auteur ; Xin-Min HAN, Auteur ; Ying DING, Auteur ; Yu-Yan CHEN, Auteur ; Xue-Feng WANG, Auteur ; Xiao-Wei WEI, Auteur ; Min-Jie WANG, Auteur ; Yan CHENG, Auteur ; Zhao-Hong NIE, Auteur ; Min ZHAO, Auteur ; Xi-Xi ZHENG, Auteur . - p.74-83. Langues : Anglais ( eng) in Journal of Child Psychology and Psychiatry > 57-1 (January 2016) . - p.74-83
| Mots-clés : |
Tourette syndrome tics herbal medicine tiapride 5-Ling Granule |
| Index. décimale : |
PER Périodiques |
| Résumé : |
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). |
| En ligne : |
http://dx.doi.org/10.1111/jcpp.12432 |
| Permalink : |
https://www.cra-rhone-alpes.org/cid/opac_css/index.php?lvl=notice_display&id=273 |
|
A proprietary herbal medicine (5-Ling Granule) for Tourette syndrome: a randomized controlled trial in Journal of Child Psychology and Psychiatry, 57-1 (January 2016)
