Subcutaneous histamine versus botulinum toxin type A in migraine prophylaxis: a randomized, double-blind study.
OBJECTIVE
To compare the efficacy and tolerability of the subcutaneous administration of histamine and botulinum toxin type A (BoNTA) in migraine prophylaxis.


BACKGROUND
Histamine has a selective affinity for H3 receptors and it may specifically inhibit the neurogenic edema response involved in migraine pathophysiology.


METHODS
One hundred patients with migraine were selected in a 12-week double-blind controlled clinical trial to evaluate the efficacy of subcutaneous administration of histamine (1-10 ng twice a week) n = 50, compared with administration of 50 U of BoNTA (one injection cycle) n = 50.


RESULTS
The data collected during the 4th week of treatment revealed a significant decrease in all parameters studied, in histamine and BoNTA (P < 0.001). After 4 weeks of treatment, but one injection cycle of 50 U BoNTA had only a 40-day period of efficacy.


CONCLUSIONS
This randomized study demonstrated that both histamine and BoNTA are similarly effective and well tolerated in reducing or eliminating headache in migraine prophylaxis. Low doses of histamine applied subcutaneously may represent a novel and effective therapeutic alternative in migraine patients and lay the clinical and pharmacological groundwork for the use of H3 agonist in migraine prophylaxis.
Millán-Guerrero
R O
RO
Department of Neurology. Unidad de Investigación Médica en Epidemiología Clínica. Hospital General de Zona UMF No 1 IMSS Colima, Col. México. millanrebeca@hotmail.com
Isais-Millán
S
S
Barreto-Vizcaíno
S
S
Rivera-Castaño
L
L
Rios-Madariaga
C
C
D000293:Adolescent; D000328:Adult; D019274:Botulinum Toxins, Type A / Q000008:administration & dosage* / Q000009:adverse effects; D004311:Double-Blind Method; D005260:Female; D006632:Histamine / Q000008:administration & dosage* / Q000009:adverse effects; D017442:Histamine Agonists / Q000008:administration & dosage / Q000009:adverse effects; D006801:Humans; D007273:Injections, Intramuscular / Q000379:methods; D007279:Injections, Subcutaneous / Q000379:methods; D008297:Male; D008875:Middle Aged; D008881:Migraine Disorders / Q000188:drug therapy* / Q000503:physiopathology / Q000517:prevention & control*; D009465:Neuromuscular Agents / Q000008:administration & dosage / Q000009:adverse effects; D016896:Treatment Outcome; D055815:Young Adult
D017442:Histamine Agonists; D009465:Neuromuscular Agents; D006632:Histamine; D019274:Botulinum Toxins, Type A