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 BotoxÒ (Botox group), 25 IU ProsigneÒ (25-Pro group), 33.3 IU ProsigneÒ (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: BotoxÒ (25 IU) or ProsigneÒ (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 ProsigneÒ resulted in 8 weeks of analgesia. The conversion factor between BotoxÒ and ProsigneÒ was 1:1.3. Conclusions: Im application of BotoxÒ (25 IU) or ProsigneÒ (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 BotoxÒ and ProsigneÒ being 1:1.3.