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α‐Dihydroergocryptine in the Prophylaxis of Migraine: A Multicenter Double‐Blind Study Versus Flunarizine
Author(s) -
Bussone G.,
Cerbo R.,
Martucci N.,
Micieli G.,
Zanferrari C.,
Grazzi L.,
Fabbrini G.,
Cavallini A.,
Granella F.,
Ambrosoli L.,
Mailland F.,
Poli A.,
Manzoni G.
Publication year - 1999
Publication title -
headache: the journal of head and face pain
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.14
H-Index - 119
eISSN - 1526-4610
pISSN - 0017-8748
DOI - 10.1046/j.1526-4610.1999.3906426.x
Subject(s) - flunarizine , migraine , medicine , placebo , aura , adverse effect , anesthesia , clinical trial , alternative medicine , pathology , calcium
This multicenter, double‐blind, clinical study was designed to compare the efficacy and safety of α‐dihydroergocryptine and flunarizine in the prophylaxis of migraine without aura. One hundred thirty‐five patients fulfilling the diagnostic criteria of the International Headache Society were enrolled at five neurologic centers. The study design included a 1‐month pretreatment phase with placebo; a 6‐month, double‐blind, double‐dummy treatment phase with α‐dihydroergocryptine (10 mg twice daily) or flunarizine (5 mg once daily); a further 3‐month follow‐up phase without treatment. Efficacy was assessed using the patient's diary. Laboratory tests, vital signs, and adverse events were monitored. Analysis of covariance for repeated measures was performed on the intent‐to‐treat sample. Both treatments led to a significant reduction in the frequency of migraine, days with headache, and use of relief medication. Overall, 51% of those treated with α‐dihydroergocryptine and 49% of those treated with flunarizine were responders (50% or greater reduction in attack frequency), the average percentage of reduction being 64% with α‐dihydroergocryptine and 51% with flunarizine. There was no significant difference between the two groups in terms of incidence of adverse events; dizziness and weight gain were the most frequent observed adverse events with α‐dihydroergocryptine and flunarizine, respectively. Based on the overall improvement in migraine parameters, α‐dihydroergocryptine can be recommended for use in migraine prophylaxis.