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Gelstat Migraine((R)) (sublingually administered feverfew and ginger compound) for acute treatment of migraine when administered during the mild pain phase.

Roger K. Cady, Curtis P. Schreiber, Mary E. Beach, Carolyn C. Hart

Med Sci Monit 2005; 11(9): PI65-69

ID: 428456


Background: Treatment of migraine headaches is often delayed due to assessingthe potential severity of an evolving headache or anticipating unwanted consequences from prescriptionmedication. Studies have demonstrated improved pain-free response when prescription treatments are takenduring the mild headache phase of a migraine. This study was designed to evaluate the efficacy of anOTC product, GelStat Migraine((R)), when taken in the early, mild pain phase of migraine. Material/Methods:An open-label study enrolling 30 subjects, male and female, with a one-year history of migraine meetingIHS diagnostic criteria with or without aura, 2-8 migraines per month and 15 headache days per month.Inclusion required having migraines that consistently started at mild and worsened to moderate or severe,if untreated, in at least 75% of attacks. Subjects also had to be able to distinguish migraine from non-migraineheadaches and reliably identify migraine early in the course of an attack. One headache was treated inthe mild pain phase with GelStat Migraine((R)), a combination of feverfew and ginger. Results: 29 evaluablesubjects completed the study, all treating at mild pain. Two hours after treatment, 48% were pain-freewith 34% reporting a headache of only mild severity. 29% reported a recurrence within 24 hours. Sideeffects were minimal and not serious. 59% of subjects were satisfied with Gelstat Migraine((R)) therapyand 41% preferred GelStat Migraine((R)) or felt it was equal to their pre-study medication. Conclusions:GelStat Migraine((R)) is effective as a first line abortive treatment for migraine when initiated earlyduring the mild headache phase.

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