Abstract

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.

Keywords: Administration, Sublingual, Analgesics - therapeutic use, Ginger, Migraine Disorders - physiopathology, Nonprescription Drugs, Pain - physiopathology, Phytotherapy, Tanacetum parthenium