Botulinum toxin type A versus amitriptyline for the treatment of chronic daily migraine.

Objective: To compare the effects of botulinum toxin type A with those of amitriptyline on the treatment of chronic daily migraines.

Methods: Chronic migraine sufferers were randomized into two groups and treated with 25 or 50mg/day of amitriptyline or 250U of botulinum toxin type A. A reduction of at least 50% in the number of pain episodes, in the intensity of pain, and in the number of drug doses for pain and reports of improvement by the patient or by the examiner were the main endpoints.

Results: Seventy-two subjects were enrolled in the study. A reduction of at least 50% in the number of days of pain was recorded in 67.8% of the patients in the BTX-A group and 72% (n=23) of the patients in the AM group (p=0.78; RR=0.94; CI=0.11-8). The reduction in the intensity of pain, as assessed using the visual analogical scale, was 50% in the BXT-A group and 55.6% in the AM group (p=0.79; RR=1.11; CI=0.32-3.8). The reduction in the number of pain drug doses was 77% for the toxin group and 71% for the amitriptyline group (p=0.76; RR=0.92; CI=0.45-1.88).

Conclusions: Botulinum toxin type A was as effective as amitriptyline for the prophylactic treatment of chronic daily migraines.