Two Botulinum Toxin A in Patients with Spasticity

A Double-Blind, Randomised, Crossover Trial of Two Botulinum Toxin Type A in Patients with Spasticity

Fabio Coelho Guarany 1,2*,

Paulo Dornelles Picon 3 ,

Nicole Ruas Guarany 2,4,

Antonio Cardoso dos Santos 1 ,

Bianca Paula Mentz Chiella 5 ,

Carolina Rocha Barone 6 ,

Lu´cia Costa Cabral Fendt 6 ,

Pedro Schestatsky 3,7

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ABSTRACT

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.

1 Physical Medicine and Rehabilitation Service, Hospital de Clınicas de Porto Alegre (HCPA), Porto Alegre, Rio Grande do Sul, Brazil,

2 Graduate Program in Medical Sciences, Universidade Federal do Rio Grande do Sul (UFRGS), Porto Alegre, Rio Grande do Sul, Brazil,

3 Department of Internal Medicine, Hospital de Clínicas de Porto Alegre (HCPA), Porto Alegre, Rio Grande do Sul, Brazil,

4 School of Occupational Therapy, Universidade Federal de Pelotas (UFPel), Pelotas, Rio Grande do Sul, Brazil,

5 Pharmacy Department, Hospital de Clınicas de Porto Alegre (HCPA), Porto Alegre, Rio Grande do Sul, Brazil,

6 Universidade Federal do Rio Grande do Sul (UFRGS), Porto Alegre, Rio Grande do Sul, Brazil,

7 Neurology Service, EMG Unit, Hospital de Clınicas de Porto Alegre (HCPA), Porto Alegre, Rio Grande do Sul, Brazil

Trial Registration: ClinicalTrials.gov NCT00819065.

Citation: Guarany FC, Picon PD, Guarany NR, dos Santos AC, Chiella BPM, et al. (2013) A Double-Blind, Randomised, Crossover Trial of Two Botulinum Toxin Type

A in Patients with Spasticity. PLoS ONE 8(2): e56479. doi:10.1371/journal.pone.0056479

Editor: Anthony E. Kline, University of Pittsburgh, United States of America

Received June 27, 2012; Accepted January 14, 2013; Published February 28, 2013

Copyright: 2013 Guarany et al. 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 credited.

Funding: Financial support was provided by FIPE-HCPA (Research and Events Support Fund at Hospital de Clı´nicas de Porto Alegre). P.S. received funding

support from CAPES, Brazil. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.

Competing Interests: The authors have declared that no competing interests exist.

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