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Efficacy of the Jingxin Zhidong Formula for Tic Disorders: A Randomized, Double Blind, Double Dummy, Parallel Controlled Trial
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...
Autores principales: | , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Dove
2022
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Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8761538/ https://www.ncbi.nlm.nih.gov/pubmed/35046656 http://dx.doi.org/10.2147/NDT.S347432 |
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author | Fan, Fei Hao, Long Zhang, Si Zhang, Ying Bian, Zhaoxiang Zhang, Xuan Wang, Qiong Han, Fei |
author_facet | Fan, Fei Hao, Long Zhang, Si Zhang, Ying Bian, Zhaoxiang Zhang, Xuan Wang, Qiong Han, Fei |
author_sort | Fan, Fei |
collection | PubMed |
description | 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). |
format | Online Article Text |
id | pubmed-8761538 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2022 |
publisher | Dove |
record_format | MEDLINE/PubMed |
spelling | pubmed-87615382022-01-18 Efficacy of the Jingxin Zhidong Formula for Tic Disorders: A Randomized, Double Blind, Double Dummy, Parallel Controlled Trial Fan, Fei Hao, Long Zhang, Si Zhang, Ying Bian, Zhaoxiang Zhang, Xuan Wang, Qiong Han, Fei Neuropsychiatr Dis Treat Clinical Trial Report 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). Dove 2022-01-11 /pmc/articles/PMC8761538/ /pubmed/35046656 http://dx.doi.org/10.2147/NDT.S347432 Text en © 2022 Fan et al. https://creativecommons.org/licenses/by-nc/3.0/This work is published and licensed by Dove Medical Press Limited. The full terms of this license are available at https://www.dovepress.com/terms.php and incorporate the Creative Commons Attribution – Non Commercial (unported, v3.0) License (http://creativecommons.org/licenses/by-nc/3.0/ (https://creativecommons.org/licenses/by-nc/3.0/) ). By accessing the work you hereby accept the Terms. Non-commercial uses of the work are permitted without any further permission from Dove Medical Press Limited, provided the work is properly attributed. For permission for commercial use of this work, please see paragraphs 4.2 and 5 of our Terms (https://www.dovepress.com/terms.php). |
spellingShingle | Clinical Trial Report Fan, Fei Hao, Long Zhang, Si Zhang, Ying Bian, Zhaoxiang Zhang, Xuan Wang, Qiong Han, Fei Efficacy of the Jingxin Zhidong Formula for Tic Disorders: A Randomized, Double Blind, Double Dummy, Parallel Controlled Trial |
title | Efficacy of the Jingxin Zhidong Formula for Tic Disorders: A Randomized, Double Blind, Double Dummy, Parallel Controlled Trial |
title_full | Efficacy of the Jingxin Zhidong Formula for Tic Disorders: A Randomized, Double Blind, Double Dummy, Parallel Controlled Trial |
title_fullStr | Efficacy of the Jingxin Zhidong Formula for Tic Disorders: A Randomized, Double Blind, Double Dummy, Parallel Controlled Trial |
title_full_unstemmed | Efficacy of the Jingxin Zhidong Formula for Tic Disorders: A Randomized, Double Blind, Double Dummy, Parallel Controlled Trial |
title_short | Efficacy of the Jingxin Zhidong Formula for Tic Disorders: A Randomized, Double Blind, Double Dummy, Parallel Controlled Trial |
title_sort | efficacy of the jingxin zhidong formula for tic disorders: a randomized, double blind, double dummy, parallel controlled trial |
topic | Clinical Trial Report |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8761538/ https://www.ncbi.nlm.nih.gov/pubmed/35046656 http://dx.doi.org/10.2147/NDT.S347432 |
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