Botulinum toxin type A for the prophylactic treatment of chronic migraine

  In 1998, Binder et al. first reported the possibility of clinical treatment of migraine with botulinum toxin type A by finding relief of migraine while using botulinum toxin type A for cosmetic wrinkle reduction. Since then, clinical studies on the treatment of migraine with botulinum toxin type A have been flourishing and have attracted the interest of researchers in many countries.  The PREEMPT (Phase 3 Research Evaluating Migraine Prophylaxis Therapy) trial, conducted in 2009, enrolled 1384 patients with chronic migraine, each consisting of a 24-week double-blind period with two rounds of botulinum toxin Each study consisted of a 24-week double-blind period with two rounds of Botox or placebo injections, followed by a 32-week unblinded period with three rounds of injections. Patients used a daily telephone diary to record headache symptoms and treatment during the acute phase, with each injection of BTX 155-195 U at 31 fixed sites, including 7 specific muscles, every 12 weeks for a total of 5 rounds of injections. Both the primary endpoint (number of headaches, headache days) and the secondary endpoints (moderate-to-severe headache days, cumulative duration of headache, HIT26 score) were significantly reduced compared to placebo during the double-blind period.  It was on the basis of these clinical trials that Botox was approved in the UK in July 2010 for the treatment of adult patients with headache symptoms lasting at least 15 days per month or migraine lasting at least 8 days per month, in order to prevent chronic migraine attacks in these patients. This made the UK the first country to use Botox, a botulinum toxin injection, and signaled a breakthrough in the traditional treatment of migraines.  In October 2010, the FDA also approved Botox for the treatment of chronic migraines in the U.S. The FDA stated that patients with chronic headaches have headaches on the vast majority of days of the month and that there is little need for the drug for those with <14d of headache days per month . Botox is administered once every 12 weeks for chronic migraines and is injected intramuscularly in multiple locations in the head and neck.  In recent years, numerous trials have also shown that the relaxation of pericranial muscles and the action of botulinum toxin type A on the musculature may also be a mechanism for the treatment of migraine, and that the analgesic mechanism of botulinum toxin type A, which inhibits peripheral sensitization by inhibiting the release of neuropeptides (glutamate, substance P, CGRP) and thus indirectly inhibits central sensitization or directly inhibits central sensitization, is consistent with the peripheral mechanism of migraine pathogenesis and may It may be the main way to relieve migraine.