Open AccessBotulinum toxin type A in the prophylactic treatment of chronic tension‐type headache: a multicentre, double‐blind, randomized, placebo‐controlled, parallel‐group study
Author(s) -
Silberstein SD,
Göbel H,
Jensen R,
Elkind AH,
DeGryse R,
Walcott JMCM,
Turkel C
Publication year - 2006
Publication title -
cephalalgia
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.57
H-Index - 125
eISSN - 1468-2982
pISSN - 0333-1024
DOI - 10.1111/j.1468-2982.2006.01114.x
Subject(s) - medicine , placebo , clinical endpoint , adverse effect , botulinum toxin , double blind , anesthesia , prophylactic treatment , placebo group , clinical trial , tension headache , migraine , alternative medicine , pathology
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 ≥50% decrease in tension headache days than did placebo ( P ≤ 0.024). Most treatment‐related adverse events were mild or moderate, and transient. BoNTA was safe and well‐tolerated in the study.