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.
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.
Goldstein
J
J
San Francisco Headache Clinic, CA, USA. SFHACLIN@aol.com
Hoffman
H D
HD
Armellino
J J
JJ
Battikha
J P
JP
Hamelsky
S W
SW
Couch
J
J
Blumenthal
H
H
Lipton
R B
RB
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
D004338:Drug Combinations; D004366:Nonprescription Drugs; D000082:Acetaminophen; D002110:Caffeine; D001241:Aspirin