Comparison of Botox^® or Prosigne^® and Facial Nerve Blockade as Adjuvant in Chronic Migraine

Abstract

Background: The treatments suggested for chronic migraine (CM) include: 1) intramuscular (im) botulinum toxin (BTX) every 12 weeks, and 2) blockade of peripheral nerves of the head. The present study evaluated the efficacy of facial nerve blockade in combination with a single administration of different low BTX. Methods: Forty patients with CM submitted to unilateral facial nerve blockade (supraorbital, supratrochlear and auriculotemporal) were divided into 4 randomized groups in a double-blind manner in order to receiveim, after 7 days: 25 IU Botox^&reg; (Botox group), 25 IU Prosigne^&reg; (25-Pro group), 33.3 IU Prosigne^&reg; (33-Pro group) or saline (control group), with the dose divided for application to 10 sites in the frontal and bilateral temporal regions. Analgesia and adverse effects were evaluated: 1) before blockade of the facial nerves and 2) 4 weeks, 3) 8 weeks and 4) 12 weeks after BTX-A or saline application (HC clinical trial no. 12465). Results: Botox^&reg; (25 IU) or Prosigne^&reg; (33.3 IU) resulted in at least seven-day intervals between headache attacks associated with 70% reduction in frequency and intensity of crises over 12 weeks (P < 0.05), while the 25 IU dose of Prosigne^&reg; resulted in 8 weeks of analgesia. The conversion factor between Botox^&reg; and Prosigne^&reg; was 1:1.3. Conclusions: Im application of Botox^&reg; (25 IU) or Prosigne^&reg; (33.3 IU) one week after nerve blockade on the painful side was equally effective for 12 weeks in patients with chronic daily headache, with the conversion factor between Botox^&reg; and Prosigne^&reg; being 1:1.3.