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

J. Goldstein, H. D. Hoffman, J. J. Armellino, J. P. Battikha, S. W. Hamelsky, J. Couch, H. Blumenthal, R. B. Lipton

Research output: Contribution to journalArticle

50 Scopus citations


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≤0.01) for AAC than placebo. The pain intensity difference from baseline was significantly greater (p≤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.

Original languageEnglish (US)
Pages (from-to)684-691
Number of pages8
Issue number7
StatePublished - Oct 14 1999


ASJC Scopus subject areas

  • Clinical Neurology

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