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

Guarany FC, Picon PD, Guarany NR, dos Santos AC, Chiella BP, Barone CR, Fendt LC, Schestatsky P - PLoS ONE (2013)

Bottom Line: 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.There were no significant differences found between the Prosigne® and Botox® treatments regarding their MAS, FIM and PEDI scores.Likewise, the incidence of adverse effects was similar between the two groups.

View Article: PubMed Central - PubMed

Affiliation: Physical Medicine and Rehabilitation Service, Hospital de Clínicas de Porto Alegre (HCPA), Porto Alegre, Rio Grande do Sul, Brazil. fguarany@hotmail.com

ABSTRACT

Background: Botulinum toxin type A (btxA) is one of the main treatment choices for patients with spasticity. Prosigne® a new released botulinum toxin serotype A may have the same effectiveness as Botox® 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 Prosigne® with Botox® 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 Prosigne® or Botox® 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 Prosigne® and Botox® 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 Prosigne® and Botox® are both efficient and comparable with respect to their efficacy and safety for the three month treatment of spasticity.

Trial registration: ClinicalTrials.gov NCT00819065.

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Related in: MedlinePlus

CONSORT 2012 Flow diagram of patients.
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pone-0056479-g001: CONSORT 2012 Flow diagram of patients.

Mentions: Patients with any cause of spasticity were eligible to participate in the study if they were older than 2 years and had no previous btxA treatment or had gone without treatment within the last 6 months. We excluded all of the patients that exhibited fixed contracture (MAS = 4) or profound atrophy in the affected limb, were currently undergoing surgical treatment for spasticity, used agents that affected neuromuscular transmission or had known contraindications to btxA, or those patients who were currently pregnant. Figure 1 shows the flow diagram of patients in the trial.


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

Guarany FC, Picon PD, Guarany NR, dos Santos AC, Chiella BP, Barone CR, Fendt LC, Schestatsky P - PLoS ONE (2013)

CONSORT 2012 Flow diagram of patients.
© Copyright Policy
Related In: Results  -  Collection

Show All Figures
getmorefigures.php?uid=PMC3585303&req=5

pone-0056479-g001: CONSORT 2012 Flow diagram of patients.
Mentions: Patients with any cause of spasticity were eligible to participate in the study if they were older than 2 years and had no previous btxA treatment or had gone without treatment within the last 6 months. We excluded all of the patients that exhibited fixed contracture (MAS = 4) or profound atrophy in the affected limb, were currently undergoing surgical treatment for spasticity, used agents that affected neuromuscular transmission or had known contraindications to btxA, or those patients who were currently pregnant. Figure 1 shows the flow diagram of patients in the trial.

Bottom Line: 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.There were no significant differences found between the Prosigne® and Botox® treatments regarding their MAS, FIM and PEDI scores.Likewise, the incidence of adverse effects was similar between the two groups.

View Article: PubMed Central - PubMed

Affiliation: Physical Medicine and Rehabilitation Service, Hospital de Clínicas de Porto Alegre (HCPA), Porto Alegre, Rio Grande do Sul, Brazil. fguarany@hotmail.com

ABSTRACT

Background: Botulinum toxin type A (btxA) is one of the main treatment choices for patients with spasticity. Prosigne® a new released botulinum toxin serotype A may have the same effectiveness as Botox® 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 Prosigne® with Botox® 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 Prosigne® or Botox® 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 Prosigne® and Botox® 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 Prosigne® and Botox® are both efficient and comparable with respect to their efficacy and safety for the three month treatment of spasticity.

Trial registration: ClinicalTrials.gov NCT00819065.

Show MeSH
Related in: MedlinePlus