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.
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.
  
  
  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.
authors.affiliation: San Francisco Headache Clinic, CA, USA. SFHACLIN@aol.com
authors.forename: J
authors.initials: J
authors.lastname: Goldstein
authors.forename: H D
authors.initials: HD
authors.lastname: Hoffman
authors.forename: J J
authors.initials: JJ
authors.lastname: Armellino
authors.forename: J P
authors.initials: JP
authors.lastname: Battikha
authors.forename: S W
authors.initials: SW
authors.lastname: Hamelsky
authors.forename: J
authors.initials: J
authors.lastname: Couch
authors.forename: H
authors.initials: H
authors.lastname: Blumenthal
authors.forename: R B
authors.initials: RB
authors.lastname: Lipton
mesh_terms: D000082:Acetaminophen / Q000008:administration & dosage / Q000627:therapeutic use*; D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001241:Aspirin / Q000008:administration & dosage / Q000627:therapeutic use*; D002110:Caffeine / Q000008:administration & dosage / Q000627:therapeutic use*; D004311:Double-Blind Method; D004338:Drug Combinations; D004363:Drug Utilization; D005260:Female; D006801:Humans; D012001:Hyperacusis / Q000188:drug therapy / Q000209:etiology; D008297:Male; D008875:Middle Aged; D008881:Migraine Disorders / Q000188:drug therapy*; D009325:Nausea / Q000188:drug therapy / Q000209:etiology; D004366:Nonprescription Drugs / Q000627:therapeutic use*; D020795:Photophobia / Q000188:drug therapy / Q000209:etiology; D012720:Severity of Illness Index
chemical_list: D004338:Drug Combinations; D004366:Nonprescription Drugs; D000082:Acetaminophen; D002110:Caffeine; D001241:Aspirin