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Neuronox versus BOTOX in the Treatment of Post-Stroke Upper Limb Spasticity: A Multicenter Randomized Controlled Trial
BACKGROUND: Botulinum toxin type A is widely used for treating spasticity. Neuronox (Neu-BoNT/A), a newly manufactured botulinum toxin a, has not yet been investigated for its efficacy and safety in the treatment of post-stroke upper limb spasticity. OBJECTIVE: We evaluated the efficacy and safety o...
Autores principales: | , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Public Library of Science
2015
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4452301/ https://www.ncbi.nlm.nih.gov/pubmed/26030192 http://dx.doi.org/10.1371/journal.pone.0128633 |
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author | Seo, Han Gil Paik, Nam-Jong Lee, Shi-Uk Oh, Byung-Mo Chun, Min Ho Kwon, Bum Sun Bang, Moon Suk |
author_facet | Seo, Han Gil Paik, Nam-Jong Lee, Shi-Uk Oh, Byung-Mo Chun, Min Ho Kwon, Bum Sun Bang, Moon Suk |
author_sort | Seo, Han Gil |
collection | PubMed |
description | BACKGROUND: Botulinum toxin type A is widely used for treating spasticity. Neuronox (Neu-BoNT/A), a newly manufactured botulinum toxin a, has not yet been investigated for its efficacy and safety in the treatment of post-stroke upper limb spasticity. OBJECTIVE: We evaluated the efficacy and safety of Neuronox (Neu-BoNT/A) compared with BOTOX (onabotulinum toxin A) for treating post-stroke upper limb spasticity. METHODS: In total, 196 stroke patients with moderate to severe upper limb spasticity were randomly assigned to either Neuronox or BOTOX intervention. The wrist flexors were mandatory and elbow, finger, and thumb flexors were optional muscles to be injected. Assessments were performed at baseline and 4, 8, and 12 weeks after the intervention. The primary outcome measure was the change from baseline of the Modified Ashworth Scale (MAS) at the wrist flexors at week 4. Secondary outcome measures included the change of MAS at each visit, response rate, Disability Assessment Scale (DAS), Carer Burden Scale, and Global Assessment of treatment benefit. RESULTS: Primary outcome measures were -1.39±0.79 and -1.56±0.81 in the Neuronox and BOTOX groups, respectively. The difference was within the noninferiority margin of 0.45 (95% upper limit=0.40). There were no significant differences between the groups in the secondary outcome and safety measures, except the change of the MAS at the elbow flexors at week 12 (-0.88±0.75 in the Neuronox group, -0.65±0.74 in the BOTOX group; P=0.0429). Both groups showed significant improvements in the MAS, DAS, and Carer Burden Scale at weeks 4, 8, and 12. CONCLUSION: Neuronox showed equivalent efficacy and safety compared with BOTOX for treating post-stroke upper limb spasticity. TRIAL REGISTRATION: ClinicalTrials.gov NCT01313767 |
format | Online Article Text |
id | pubmed-4452301 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2015 |
publisher | Public Library of Science |
record_format | MEDLINE/PubMed |
spelling | pubmed-44523012015-06-09 Neuronox versus BOTOX in the Treatment of Post-Stroke Upper Limb Spasticity: A Multicenter Randomized Controlled Trial Seo, Han Gil Paik, Nam-Jong Lee, Shi-Uk Oh, Byung-Mo Chun, Min Ho Kwon, Bum Sun Bang, Moon Suk PLoS One Research Article BACKGROUND: Botulinum toxin type A is widely used for treating spasticity. Neuronox (Neu-BoNT/A), a newly manufactured botulinum toxin a, has not yet been investigated for its efficacy and safety in the treatment of post-stroke upper limb spasticity. OBJECTIVE: We evaluated the efficacy and safety of Neuronox (Neu-BoNT/A) compared with BOTOX (onabotulinum toxin A) for treating post-stroke upper limb spasticity. METHODS: In total, 196 stroke patients with moderate to severe upper limb spasticity were randomly assigned to either Neuronox or BOTOX intervention. The wrist flexors were mandatory and elbow, finger, and thumb flexors were optional muscles to be injected. Assessments were performed at baseline and 4, 8, and 12 weeks after the intervention. The primary outcome measure was the change from baseline of the Modified Ashworth Scale (MAS) at the wrist flexors at week 4. Secondary outcome measures included the change of MAS at each visit, response rate, Disability Assessment Scale (DAS), Carer Burden Scale, and Global Assessment of treatment benefit. RESULTS: Primary outcome measures were -1.39±0.79 and -1.56±0.81 in the Neuronox and BOTOX groups, respectively. The difference was within the noninferiority margin of 0.45 (95% upper limit=0.40). There were no significant differences between the groups in the secondary outcome and safety measures, except the change of the MAS at the elbow flexors at week 12 (-0.88±0.75 in the Neuronox group, -0.65±0.74 in the BOTOX group; P=0.0429). Both groups showed significant improvements in the MAS, DAS, and Carer Burden Scale at weeks 4, 8, and 12. CONCLUSION: Neuronox showed equivalent efficacy and safety compared with BOTOX for treating post-stroke upper limb spasticity. TRIAL REGISTRATION: ClinicalTrials.gov NCT01313767 Public Library of Science 2015-06-01 /pmc/articles/PMC4452301/ /pubmed/26030192 http://dx.doi.org/10.1371/journal.pone.0128633 Text en © 2015 Seo et al http://creativecommons.org/licenses/by/4.0/ This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are properly credited. |
spellingShingle | Research Article Seo, Han Gil Paik, Nam-Jong Lee, Shi-Uk Oh, Byung-Mo Chun, Min Ho Kwon, Bum Sun Bang, Moon Suk Neuronox versus BOTOX in the Treatment of Post-Stroke Upper Limb Spasticity: A Multicenter Randomized Controlled Trial |
title | Neuronox versus BOTOX in the Treatment of Post-Stroke Upper Limb Spasticity: A Multicenter Randomized Controlled Trial |
title_full | Neuronox versus BOTOX in the Treatment of Post-Stroke Upper Limb Spasticity: A Multicenter Randomized Controlled Trial |
title_fullStr | Neuronox versus BOTOX in the Treatment of Post-Stroke Upper Limb Spasticity: A Multicenter Randomized Controlled Trial |
title_full_unstemmed | Neuronox versus BOTOX in the Treatment of Post-Stroke Upper Limb Spasticity: A Multicenter Randomized Controlled Trial |
title_short | Neuronox versus BOTOX in the Treatment of Post-Stroke Upper Limb Spasticity: A Multicenter Randomized Controlled Trial |
title_sort | neuronox versus botox in the treatment of post-stroke upper limb spasticity: a multicenter randomized controlled trial |
topic | Research Article |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4452301/ https://www.ncbi.nlm.nih.gov/pubmed/26030192 http://dx.doi.org/10.1371/journal.pone.0128633 |
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