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  • Title: Treatment of severe, disabling migraine attacks in an over-the-counter population of migraine sufferers: results from three randomized, placebo-controlled studies of the combination of acetaminophen, aspirin, and caffeine.
    Author: Goldstein J, Hoffman HD, Armellino JJ, Battikha JP, Hamelsky SW, Couch J, Blumenthal H, Lipton RB.
    Journal: Cephalalgia; 1999 Sep; 19(7):684-91. PubMed ID: 10524663.
    Abstract:
    OBJECTIVE: To examine the benefits of acetaminophen, aspirin, and caffeine (AAC) in the treatment of severe, disabling migraine attacks, in a population of migraine sufferers for whom over-the-counter (OTC) medications are appropriate. BACKGROUND: Subjects (n = 1220) who met the International Headache Society criteria for migraine with or without aura were included in three independent clinical studies. DESIGN/METHODS: Post-hoc analysis of 172 subjects who met the criteria for severe, disabling migraine reported a history of migraine attacks characterized by at least severe pain and severe disability, and treated attacks with severe pain and at least severe disability. Subjects who usually vomited with 20% or more of their migraine attacks, and those with incapacitating disability (subjects who required bed rest for more than 50% of their attacks) were not eligible for enrollment. RESULTS: From 1 h and continuing through 6 h postdose, the proportion of responders was significantly greater (p< or =0.01) for AAC than placebo. The pain intensity difference from baseline was significantly greater (p< or =0.05) for AAC than placebo from 0.5 h through 6 h. The proportion of subjects reporting improvement in functional disability, photophobia, and phonophobia was significantly greater for AAC than placebo from 2 h through 6 h postdose. CONCLUSIONS: The nonprescription combination of AAC was well tolerated and effective.
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