Acetaminophen, aspirin, and caffeine versus sumatriptan succinate in the early treatment of migraine: results from the ASSET trial.
OBJECTIVE
To address the need for a rigorous, direct comparison of prescription and over-the-counter (OTC) migraine drugs and to expand the database on early treatment of migraine.


BACKGROUND
Most people who experience migraine use OTC medications to treat their symptoms, but no head-to-head clinical trials comparing these agents with prescription migraine therapies have been published. In addition, even though most migraineurs treat early in the attack, few studies have been conducted to reflect this treatment pattern.


METHODS
We compared a combination of nonprescription migraine medication (acetaminophen 500 mg, aspirin 500 mg, and caffeine 130 mg) with a prescription migraine product (50 mg sumatriptan) in a randomized, controlled clinical trial in which subjects treated at the first sign of a migraine attack. Subjects who reported vomiting during more than 20% of migraine episodes or who required bedrest during more than 50% of migraine episodes were excluded from the study. Of the 188 subjects randomized, 171 took study medication and were included in the analysis.


CONCLUSIONS
The combination of acetaminophen, aspirin, and caffeine was significantly more effective (P > .05) than sumatriptan in the early treatment of migraine, as shown by superiority in summed pain intensity difference, pain relief, pain intensity difference, response, sustained response, relief of associated symptoms, use of rescue medication, disability relief, and global assessments of effectiveness. An additional, larger clinical trial is needed to confirm these results.
Goldstein
Jerome
J
San Francisco Headache Clinic, San Francisco Clinical Research Center, CA 94109, USA.
Silberstein
Stephen D
SD
Saper
Joel R
JR
Elkind
Arthur H
AH
Smith
Timothy R
TR
Gallagher
R Michael
RM
Battikha
Jean-Pierre
JP
Hoffman
Howard
H
Baggish
Jeffrey
J
D000082:Acetaminophen / Q000627:therapeutic use*; D000328:Adult; D018712:Analgesics, Non-Narcotic / Q000627:therapeutic use; D000704:Analysis of Variance; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000627:therapeutic use; D001241:Aspirin / Q000627:therapeutic use*; D002110:Caffeine / Q000627:therapeutic use*; D000697:Central Nervous System Stimulants / Q000627:therapeutic use; D016009:Chi-Square Distribution; D004311:Double-Blind Method; D004338:Drug Combinations; D004415:Dyspepsia / Q000139:chemically induced; D005260:Female; D006801:Humans; D008297:Male; D008881:Migraine Disorders / Q000188:drug therapy*; D009325:Nausea / Q000139:chemically induced; D004366:Nonprescription Drugs; D011446:Prospective Studies; D017366:Serotonin Receptor Agonists / Q000009:adverse effects / Q000627:therapeutic use; D018170:Sumatriptan / Q000009:adverse effects / Q000627:therapeutic use*; D016896:Treatment Outcome
D018712:Analgesics, Non-Narcotic; D000894:Anti-Inflammatory Agents, Non-Steroidal; D000697:Central Nervous System Stimulants; D004338:Drug Combinations; D004366:Nonprescription Drugs; D017366:Serotonin Receptor Agonists; D000082:Acetaminophen; D002110:Caffeine; D018170:Sumatriptan; D001241:Aspirin