"Botulinum toxin type A in the prophylactic treatment of chronic tensio" by Stephen D. Silberstein, H. Göbel et al.
 

Document Type

Article

Publication Date

July 2006

Comments

This article has been peer reviewed. It is the author's final version prior to publication in Cephalalgia 26(7):790-800, July 2006. The definitive version is available at www.blackwell-synergy.com ( http://dx.doi.org/10.1111/j.1468-2982.2006.01114.x). Copyright © 2006 by Blackwell Publishing Ltd.

Abstract

We studied the safety and efficacy of 0 U, 50 U, 100 U, 150 U (five sites), 86 Usub and 100 Usub (three sites) botulinum toxin type A (BoNTA; BOTOX); Allergan, Inc., Irvine, CA, USA) for the prophylaxis of chronic tension-type headache (CTTH). Three hundred patients (62.3% female; mean age 42.6 years) enrolled. For the primary endpoint, the mean change from baseline in the number of TTH-free days per month, there was no statistically significant difference between placebo and four BoNTA groups, but a significant difference favouring placebo vs. BoNTA 150 was observed (4.5 vs. 2.8 tension headache-free days/month; P = 0.007). All treatment groups improved at day 60. Although efficacy was not demonstrated for the primary endpoint, at day 90, more patients in three BoNTA groups had >or=50% decrease in tension headache days than did placebo (P

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