A double-blind, randomised, crossover trial of two botulinum toxin type A in patients with spasticity

Detalhes bibliográficos
Autor(a) principal: Guarany, Fábio Coelho
Data de Publicação: 2013
Outros Autores: Picon, Paulo Dornelles, Guarany, Nicole Ruas, Santos, Antonio Cardoso dos, Chiella, Bianca Paula Mentz, Barone, Carolina Rocha, Fendt, Lúcia Costa Cabral, Schestatsky, Pedro
Tipo de documento: Artigo
Idioma: eng
Título da fonte: Repositório Institucional da UFRGS
Texto Completo: http://hdl.handle.net/10183/200420
Resumo: Background: Botulinum toxin type A (btxA) is one of the main treatment choices for patients with spasticity. ProsigneH a new released botulinum toxin serotype A may have the same effectiveness as BotoxH in focal dystonia. However, there are no randomized clinical trials comparing these formulations in spasticity treatment. The aim of our study was to compare the efficacy and safety of ProsigneH with BotoxH in the treatment of spasticity. Methodology/Principal Findings: We performed a double-blind, randomized, crossover study consisting of 57 patients with clinically meaningful spasticity. The patients were assessed at baseline, 4 and 12 weeks after ProsigneH or BotoxH administration. The main outcomes were changes in the patients’ Modified Ashworth Scale (MAS), Functional Independence Measure (FIM) and Pediatric Evaluation of Disability Inventory (PEDI) scores and adverse effects related to the botulinum toxin. Both of the toxins were significantly effective in relieving the level of spasticity in adults and children. There were no significant differences found between the ProsigneH and BotoxH treatments regarding their MAS, FIM and PEDI scores. Likewise, the incidence of adverse effects was similar between the two groups. Conclusion: Our results suggest that ProsigneH and BotoxH are both efficient and comparable with respect to their efficacy and safety for the three month treatment of spasticity.
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spelling Guarany, Fábio CoelhoPicon, Paulo DornellesGuarany, Nicole RuasSantos, Antonio Cardoso dosChiella, Bianca Paula MentzBarone, Carolina RochaFendt, Lúcia Costa CabralSchestatsky, Pedro2019-10-10T03:50:17Z20131932-6203http://hdl.handle.net/10183/200420000892451Background: Botulinum toxin type A (btxA) is one of the main treatment choices for patients with spasticity. ProsigneH a new released botulinum toxin serotype A may have the same effectiveness as BotoxH in focal dystonia. However, there are no randomized clinical trials comparing these formulations in spasticity treatment. The aim of our study was to compare the efficacy and safety of ProsigneH with BotoxH in the treatment of spasticity. Methodology/Principal Findings: We performed a double-blind, randomized, crossover study consisting of 57 patients with clinically meaningful spasticity. The patients were assessed at baseline, 4 and 12 weeks after ProsigneH or BotoxH administration. The main outcomes were changes in the patients’ Modified Ashworth Scale (MAS), Functional Independence Measure (FIM) and Pediatric Evaluation of Disability Inventory (PEDI) scores and adverse effects related to the botulinum toxin. Both of the toxins were significantly effective in relieving the level of spasticity in adults and children. There were no significant differences found between the ProsigneH and BotoxH treatments regarding their MAS, FIM and PEDI scores. Likewise, the incidence of adverse effects was similar between the two groups. Conclusion: Our results suggest that ProsigneH and BotoxH are both efficient and comparable with respect to their efficacy and safety for the three month treatment of spasticity.application/pdfengPloS one. San Francisco. Vol. 8, no. 2 (Feb. 2013), e56479, 6 p.Espasticidade muscularToxinas botulínicas tipo AA double-blind, randomised, crossover trial of two botulinum toxin type A in patients with spasticityEstrangeiroinfo:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersioninfo:eu-repo/semantics/openAccessreponame:Repositório Institucional da UFRGSinstname:Universidade Federal do Rio Grande do Sul (UFRGS)instacron:UFRGSTEXT000892451.pdf.txt000892451.pdf.txtExtracted Texttext/plain25714http://www.lume.ufrgs.br/bitstream/10183/200420/2/000892451.pdf.txta43b8b6149e56e413ff38bac4166143aMD52ORIGINAL000892451.pdfTexto completo (inglês)application/pdf311803http://www.lume.ufrgs.br/bitstream/10183/200420/1/000892451.pdfe6f1f1be3a8caef0f18c9c0909b71d08MD5110183/2004202023-09-23 03:37:11.77113oai:www.lume.ufrgs.br:10183/200420Repositório de PublicaçõesPUBhttps://lume.ufrgs.br/oai/requestopendoar:2023-09-23T06:37:11Repositório Institucional da UFRGS - Universidade Federal do Rio Grande do Sul (UFRGS)false
dc.title.pt_BR.fl_str_mv A double-blind, randomised, crossover trial of two botulinum toxin type A in patients with spasticity
title A double-blind, randomised, crossover trial of two botulinum toxin type A in patients with spasticity
spellingShingle A double-blind, randomised, crossover trial of two botulinum toxin type A in patients with spasticity
Guarany, Fábio Coelho
Espasticidade muscular
Toxinas botulínicas tipo A
title_short A double-blind, randomised, crossover trial of two botulinum toxin type A in patients with spasticity
title_full A double-blind, randomised, crossover trial of two botulinum toxin type A in patients with spasticity
title_fullStr A double-blind, randomised, crossover trial of two botulinum toxin type A in patients with spasticity
title_full_unstemmed A double-blind, randomised, crossover trial of two botulinum toxin type A in patients with spasticity
title_sort A double-blind, randomised, crossover trial of two botulinum toxin type A in patients with spasticity
author Guarany, Fábio Coelho
author_facet Guarany, Fábio Coelho
Picon, Paulo Dornelles
Guarany, Nicole Ruas
Santos, Antonio Cardoso dos
Chiella, Bianca Paula Mentz
Barone, Carolina Rocha
Fendt, Lúcia Costa Cabral
Schestatsky, Pedro
author_role author
author2 Picon, Paulo Dornelles
Guarany, Nicole Ruas
Santos, Antonio Cardoso dos
Chiella, Bianca Paula Mentz
Barone, Carolina Rocha
Fendt, Lúcia Costa Cabral
Schestatsky, Pedro
author2_role author
author
author
author
author
author
author
dc.contributor.author.fl_str_mv Guarany, Fábio Coelho
Picon, Paulo Dornelles
Guarany, Nicole Ruas
Santos, Antonio Cardoso dos
Chiella, Bianca Paula Mentz
Barone, Carolina Rocha
Fendt, Lúcia Costa Cabral
Schestatsky, Pedro
dc.subject.por.fl_str_mv Espasticidade muscular
Toxinas botulínicas tipo A
topic Espasticidade muscular
Toxinas botulínicas tipo A
description Background: Botulinum toxin type A (btxA) is one of the main treatment choices for patients with spasticity. ProsigneH a new released botulinum toxin serotype A may have the same effectiveness as BotoxH in focal dystonia. However, there are no randomized clinical trials comparing these formulations in spasticity treatment. The aim of our study was to compare the efficacy and safety of ProsigneH with BotoxH in the treatment of spasticity. Methodology/Principal Findings: We performed a double-blind, randomized, crossover study consisting of 57 patients with clinically meaningful spasticity. The patients were assessed at baseline, 4 and 12 weeks after ProsigneH or BotoxH administration. The main outcomes were changes in the patients’ Modified Ashworth Scale (MAS), Functional Independence Measure (FIM) and Pediatric Evaluation of Disability Inventory (PEDI) scores and adverse effects related to the botulinum toxin. Both of the toxins were significantly effective in relieving the level of spasticity in adults and children. There were no significant differences found between the ProsigneH and BotoxH treatments regarding their MAS, FIM and PEDI scores. Likewise, the incidence of adverse effects was similar between the two groups. Conclusion: Our results suggest that ProsigneH and BotoxH are both efficient and comparable with respect to their efficacy and safety for the three month treatment of spasticity.
publishDate 2013
dc.date.issued.fl_str_mv 2013
dc.date.accessioned.fl_str_mv 2019-10-10T03:50:17Z
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dc.identifier.issn.pt_BR.fl_str_mv 1932-6203
dc.identifier.nrb.pt_BR.fl_str_mv 000892451
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dc.language.iso.fl_str_mv eng
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dc.relation.ispartof.pt_BR.fl_str_mv PloS one. San Francisco. Vol. 8, no. 2 (Feb. 2013), e56479, 6 p.
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