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Acetaminophen, Aspirin, and Caffeine Versus Sumatriptan Succinate in the Early Treatment of Migraine: Results From the ASSET trial


  • Jerome Goldstein MD,

  • Stephen D. Silberstein MD,

  • Joel R. Saper MD, FACP, FAAN,

  • Arthur H. Elkind MD,

  • Timothy R. Smith MD,

  • R. Michael Gallagher DO, FACOFP,

  • Jean-Pierre Battikha MS,

  • Howard Hoffman MD,

  • Jeffrey Baggish MD

  • From the San Francisco Headache Clinic, San Francisco, CA (Dr. Goldstein); Thomas Jefferson University, Philadelphia, PA (Dr. Silberstein); Michigan Head Pain & Neurological Institute, Ann Arbor, MI (Dr. Saper); Elkind Headache Center, Mount Vernon, NY (Dr. Elkind); Unity Health Research, Ryan Headache Center, Chesterfield, MO (Dr. Smith); UMDNJ, School of Osteopathic Medicine, Moorestown, NJ (Dr. Gallgher); Bristol-Myers Squibb, Plainsboro, NJ (Mr. Battikha); Unaffiliated, South Orange, NJ (Dr. Hoffman); and Unaffiliated, Blue Bell, PA (Dr. Baggish).

Address all correspondence to Dr. Jerome Goldstein, San Francisco Headache Clinic, San Francisco Clinical Research Center, 909 Hyde Street, Suite 322, San Francisco CA 94109.


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.

Conclusion.—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.