A critical review of the use of botulinum toxin in orofacial pain disorders.

This article reviews the appropriate use, cautions, and contraindication for botulinum neurotoxin (BoNT) and reviews the peer-reviewed literature that describes its efficacy for treatment of various chronic orofacial pain disorders. The literature has long suggested that BoNT is of value for orofacial hyperactivity and more recently for some orofacial pain disorders; however, the results are not as promising for orofacial pain. The available data from randomized, double-blind, placebo-controlled trials (RBCTs) do not support the use of BoNT as a substantially better therapy than what is being used already. The one exception is that BoNT has reasonable RBCT data to support its use as a migraine prophylaxis therapy. The major caveat is that the use of BoNT in chronic orofacial pain is "off-label".