title: A double-blind, randomized, crossover study of prosigne versus botox in patients with blepharospasm and hemifacial spasm.
abstract: There is a lack of evidence on the clinical efficacy and safety of the recently released Chinese botulinum toxin serotype A (Prosigne) for the treatment of focal dystonias and hemifacial spasm. Determining a more precise role of Prosigne in the treatment of such conditions is of paramount importance, because botulinum toxin type A treatments have a huge economic implication in health services, especially in developing countries. The aim of our study was to compare the efficacy and safety of Prosigne in the treatment of blepharospasm and hemifacial spasm in comparison to Botox. We performed a double-blind, randomized, crossover study enrolling 26 patients. There were no significant differences between Prosigne and Botox regarding subjective global improvement, response onset, efficacy duration, and incidence and severity of adverse events. Our results suggest that Prosigne and Botox are comparable with respect to efficacy and safety for the short-term treatment of blepharospasm and hemifacial spasm.
authors.affiliation: Department of Neurology, Hospital de Clínicas de Porto Alegre, Brazil. pedro.schestatsky@gmail.com
authors.forename: Carlos R M
authors.initials: CR
authors.lastname: Rieder
authors.forename: Pedro
authors.initials: P
authors.lastname: Schestatsky
authors.forename: Mariana Peixoto
authors.initials: MP
authors.lastname: Socal
authors.forename: Thaís Lampert
authors.initials: TL
authors.lastname: Monte
authors.forename: Daniele
authors.initials: D
authors.lastname: Fricke
authors.forename: João
authors.initials: J
authors.lastname: Costa
authors.forename: Paulo Dornelles
authors.initials: PD
authors.lastname: Picon
mesh_terms: D001764:Blepharospasm / Q000188:drug therapy*; D019274:Botulinum Toxins, Type A / Q000494:pharmacology*; D018592:Cross-Over Studies; D004311:Double-Blind Method; D004365:Drugs, Chinese Herbal / Q000494:pharmacology*; D005260:Female; D019569:Hemifacial Spasm / Q000188:drug therapy*; D006801:Humans; D008297:Male; D008875:Middle Aged; D016896:Treatment Outcome
chemical_list: D004365:Drugs, Chinese Herbal; D019274:Botulinum Toxins, Type A; C556222:prosigne