Botulinum toxin as preventive treatment for migraine: a randomized double-blind study.
OBJECTIVE
To determine if botulinum toxin type A (BoNT-A) injections can reduce the frequency and severity of migraines.


METHODS
Patients (n = 127) were randomized to receive placebo or two doses of BoNT-A (Dysport). The primary endpoint was reduction in number of migraine attacks up to week 8 and between weeks 8 and 12 after injection. Patient diaries were used to record secondary endpoints, including frequency, severity and duration of migraine attacks.


RESULTS
There was a mean reduction of 0.54 and 0.94 attacks/month with placebo and BoNT-A, respectively, and absolute attack count was less in the verum group (3.6 vs. 4.2 attacks/month), but this was not statistically significant. The patients' global assessment of efficacy was significantly better than placebo in the high-dose group (p = 0.02) but no effects were seen for the other secondary efficacy parameters.


CONCLUSIONS
Our study showed a trend towards a reduced attack rate with verum but did not show any statistically significant efficacy of BoNT-A in the prophylactic treatment of migraine.
Petri
Susanne
S
Department of Neurology, Medizinische Hochschule, Hannover, Germany. petri.susanne@mh-hannover.de
Tölle
Thomas
T
Straube
Andreas
A
Pfaffenrath
Volker
V
Stefenelli
Ulrich
U
Ceballos-Baumann
Andres
A
D000293:Adolescent; D000328:Adult; D017668:Age of Onset; D000368:Aged; D019274:Botulinum Toxins, Type A / Q000627:therapeutic use*; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007273:Injections, Intramuscular; D008297:Male; D008875:Middle Aged; D008881:Migraine Disorders / Q000517:prevention & control*; D018579:Patient Selection; D018709:Statistics, Nonparametric; D016896:Treatment Outcome
D019274:Botulinum Toxins, Type A