Is there a role for botulinum toxin in the treatment of migraine?

In this review, the studies and case reports that are available from reference systems and published congress contributions on the treatment of migraine with botulinum toxin are evaluated. The studies and reports were analyzed with respect to the study design, the efficacy parameters, and the significance of results. One double-blind, placebo-controlled, randomized study with negative (for a 75 U dose of botulinum toxin) and positive (for a 25 U dose of botulinum toxin) evidence of efficacy, one that was a partly positive controlled study (pain intensity, but not attack-frequency improved), and four positive open studies were available. For the acute treatment of migraine with botulinum toxin, only positive case reports were published. As a result of this analysis, there is no sufficient scientific evidence for a treatment recommendation of migraine with botulinum toxin. Further studies are needed for a definite evaluation of subgroups with probable benefit from such a treatment and for the comparison of botulinum toxin with other migraine prophylactic drugs.