Introdução: A toxina botulínica tipo A é uma das principais modalidades de tratamento para pacientes com espasticidade. Uma nova preparações de toxina botulínica sorotipo tipo A, Prosigne®, foi lançada sugerindo ter a mesma eficácia que Botox®. No entanto, não há ensaios clínicos randomizados comparando essas formulações no tratamento da espasticidade. Objetivos: O objetivo deste estudo foi comparar a eficácia ea segurança do Prosigne® com Botox® no tratamento da espasticidade. Métodos: Foi realizado um estudo duplo-cego, randomizado e cruzado com 57 pacientes com espasticidade clinicamente significativas. Os pacientes foram avaliados no início do estudo, 4 e 12 semanas após a injeção de Prosigne® ou Botox®. Resultados: Os principais resultados foram avaliados pelas mudanças na Escala de Ashworth Modificada (EAM), Medida de Independência Funcional MIF) e Pediatric Evaluation of Disability Inventory (PEDI) e os efeitos adversos relacionados ao uso da toxina botulínica. Ambas as toxinas foram significativamente eficazes em diminuir o grau de espasticidade, em adultos e crianças. Não houveram diferenças significativas entre os tratamentos Prosigne® e Botox® em relação aos escores MAS, e FIM PEDI. Da mesma forma, a incidência de efeitos adversos foi similar entre os dois grupos. Conclusão: Nossos resultados sugerem que Prosigne® e Botox® são comparáveis em relação a sua eficácia e segurança no tratamento de três meses da espasticidade. / Background: Botulinum toxin type A 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®. However, there are no randomized clinical trials comparing these formulations in spasticity treatment. Objective: The aim of our study was to compare the efficacy and safety of Prosigne® with Botox® in the treatment of spasticity. Methods: 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. Results: 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.

Introdução: A toxina botulínica tipo A é uma das principais modalidades de tratamento para pacientes com espasticidade. Uma nova preparações de toxina botulínica sorotipo tipo A, Prosigne®, foi lançada sugerindo ter a mesma eficácia que Botox®. No entanto, não há ensaios clínicos randomizados comparando essas formulações no tratamento da espasticidade. Objetivos: O objetivo deste estudo foi comparar a eficácia ea segurança do Prosigne® com Botox® no tratamento da espasticidade. Métodos: Foi realizado um estudo duplo-cego, randomizado e cruzado com 57 pacientes com espasticidade clinicamente significativas. Os pacientes foram avaliados no início do estudo, 4 e 12 semanas após a injeção de Prosigne® ou Botox®. Resultados: Os principais resultados foram avaliados pelas mudanças na Escala de Ashworth Modificada (EAM), Medida de Independência Funcional MIF) e Pediatric Evaluation of Disability Inventory (PEDI) e os efeitos adversos relacionados ao uso da toxina botulínica. Ambas as toxinas foram significativamente eficazes em diminuir o grau de espasticidade, em adultos e crianças. Não houveram diferenças significativas entre os tratamentos Prosigne® e Botox® em relação aos escores MAS, e FIM PEDI. Da mesma forma, a incidência de efeitos adversos foi similar entre os dois grupos. Conclusão: Nossos resultados sugerem que Prosigne® e Botox® são comparáveis em relação a sua eficácia e segurança no tratamento de três meses da espasticidade. / Background: Botulinum toxin type A 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®. However, there are no randomized clinical trials comparing these formulations in spasticity treatment. Objective: The aim of our study was to compare the efficacy and safety of Prosigne® with Botox® in the treatment of spasticity. Methods: 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. Results: 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.

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Drooling management in the neurologically impaired pediatric population is a challenge. Surgery is considered an invasive procedure, while behaviour modification techniques, correction of situational factors and oral-motor therapy do not always produce sustained improvement. In recent years Botox® has been investigated. This study comprised analyses of clinical data obtained from a Drooling Treatment Project (DTP) conducted at a school for special needs children in South Africa. The aims of the DTP were to establish the response of drooling in a number of different contexts, following bilateral submandibular salivary gland injections of Botox®. Two groups of children were involved, 7 children with cerebral palsy and 2 children with operculum syndrome. Drooling was assessed in 5 different situations and at different time points pre- and post Botox® injection up to 6 months. Parents’/primary caregivers’ perceptions of drooling and treatment with Botox® were also measured using an interview form and a quality of life questionnaire. Results showed that drooling was reduced in all situations, with significant reductions in the general and communicating situations. These results indicate that the context in which drooling occurs is an important factor and suggest the value of considering the situational context when making drooling judgements. Further, there was a difference in the pattern of response between the 2 groups. This finding has implications, not only for future research, but also for models of explanation of the effects of Botox®. Most parents/primary caregivers felt their children’s lives and their own had improved following the Botox® injection and would repeat the treatment. Clinical and research implications are discussed, with reference to the South African context.

Can a common facial cosmetic procedure buffer against the negative impact of adverse social interactions? This pilot tested the hypothesis that an injection of botulinum toxin (Botox) to the corrugator supercilii muscles used in anger, compared to a placebo injection to the same location, will reduce the impact of social rejection on mood, self-esteem, control, meaningful existence, and aggression. Freezing facial musculature was hypothesized to alter the first physical signal of negative emotional reactions, thereby reducing the impact of social rejection on distress and aggression. This was the first study using Botox to examine the effects of reduced facial feedback on felt emotions during social interactions. While the findings in this pilot were not statistically significant, a trend in the data suggests that the effect was in the opposite direction of the prediction such that participants in the Botox (vs. saline) condition experienced greater feelings of rejection. Further investigation is needed.

Botulinumtoxin ein Neurotoxin, das lange nur als Verursacher des meist tödlich verlaufenden Botulismus bekannt war, wird immer häufiger bei medizinischen Indikationen eingesetzt. So hat sich die Injektion von Botulinumtoxin in den vergangenen Jahren ebenfalls in der ästhetischen Medizin etabliert. Anlässlich dieser Entwicklung wurde ein freiwilliger Therapieversuch mit der Fragestellung durchgeführt, ob sich die Reduktion der Glabellafalte (Zornesfalte) positiv auf die Lebensqualität der Betroffenen auswirkt.

No description available.