RESUMO
BACKGROUND: Treatment of migraine headaches is often delayed due to assessing the potential severity of an evolving headache or anticipating unwanted consequences from prescription medication. Studies have demonstrated improved pain-free response when prescription treatments are taken during the mild headache phase of a migraine. This study was designed to evaluate the efficacy of an OTC product, GelStat Migraine, 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 meeting IHS diagnostic criteria with or without aura, 2-8 migraines per month and < or = 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-migraine headaches and reliably identify migraine early in the course of an attack. One headache was treated in the mild pain phase with GelStat Migraine, a combination of feverfew and ginger. RESULTS: 29 evaluable subjects completed the study, all treating at mild pain. Two hours after treatment, 48% were pain-free with 34% reporting a headache of only mild severity. 29% reported a recurrence within 24 hours. Side effects were minimal and not serious. 59% of subjects were satisfied with Gelstat Migraine therapy and 41% preferred GelStat Migraine or felt it was equal to their pre-study medication. CONCLUSIONS: GelStat Migraine is effective as a first line abortive treatment for migraine when initiated early during the mild headache phase.