Botulinum toxin type A in the prophylactic treatment of chronic tension-type headache: a multicentre, double-blind, randomized, placebo-controlled, parallel-group study.
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 <or= 0.024). Most treatment-related adverse events were mild or moderate, and transient. BoNTA was safe and well-tolerated in the study.
Silberstein
S D
SD
Jefferson Headache Center, Thomas Jefferson University, Philadelphia, PA 19107, USA.
Göbel
H
H
Jensen
R
R
Elkind
A H
AH
Degryse
R
R
Walcott
J M C M
JM
Turkel
C
C
D000293:Adolescent; D000328:Adult; D000368:Aged; D019274:Botulinum Toxins, Type A / Q000627:therapeutic use*; D015331:Cohort Studies; D004311:Double-Blind Method; D005060:Europe / Q000453:epidemiology; D005260:Female; D006801:Humans; D015994:Incidence; D008297:Male; D008875:Middle Aged; D009656:North America / Q000453:epidemiology; D010147:Pain Measurement / Q000187:drug effects*; D015990:Placebo Effect; D018570:Risk Assessment / Q000379:methods*; D012307:Risk Factors; D018781:Tension-Type Headache / Q000453:epidemiology* / Q000517:prevention & control*; D016896:Treatment Outcome
D019274:Botulinum Toxins, Type A