Subcutaneous histamine versus topiramate in migraine prophylaxis: a double-blind study.
BACKGROUND
Histamine has a selective affinity for H3 receptors and it may specifically inhibit the neurogenic edema response involved in migraine pathophysiology.


OBJECTIVE
To evaluate the therapeutic potential of subcutaneous administration of histamine in migraine prophylaxis, compared with oral administration of topiramate.


METHODS
Ninety 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) compared with oral administration of topiramate (100 mg daily dose). The variables studied were: headache intensity, frequency, duration, analgesic intake and Migraine Disability Assessment.


RESULTS
The data collected during the 12 weeks of treatment revealed that headache symptoms improved in both the histamine and topiramate groups, which was evident within the first month after the initiation of treatment, with statistically significant (p < 0.001) reductions in headache frequency (50%), Migraine Disability Assessment score (75%), intensity of pain (51%), duration of migraine attacks (45%), as well as in the use of rescue medication (52%).


CONCLUSIONS
The present study provides evidence of the efficacy of subcutaneously applied histamine and orally administered topiramate in migraine prophylaxis. Subcutaneously applied histamine may represent a novel and effective therapeutic alternative in resistant migraine patients.
Millán-Guerrero
R O
RO
Department of Neurology, Unidad de Investigación Médica en Epidemiología Clínica, Hospital General de Zona UMF No 1 IMSS Colima, Colima, México. millanrebeca@hotmail.com
Isais-Millán
R
R
Barreto-Vizcaíno
S
S
Gutiérrez
I
I
Rivera-Castaño
L
L
Trujillo-Hernández
B
B
Baltazar
L M
LM
D000293:Adolescent; D000328:Adult; D004311:Double-Blind Method; D005260:Female; D005632:Fructose / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D006632:Histamine / Q000008:administration & dosage* / Q000009:adverse effects; D017442:Histamine Agonists / Q000008:administration & dosage* / Q000009:adverse effects; D006801:Humans; D007279:Injections, Subcutaneous; D008297:Male; D008875:Middle Aged; D008881:Migraine Disorders / Q000517:prevention & control*; D018696:Neuroprotective Agents / Q000008:administration & dosage* / Q000009:adverse effects; D000077236:Topiramate
D017442:Histamine Agonists; D018696:Neuroprotective Agents; D000077236:Topiramate; D005632:Fructose; D006632:Histamine