Treatment of menstruation-associated migraine with the nonprescription combination of acetaminophen, aspirin, and caffeine: Results from three randomized, placebo-controlled studies

• Published in: Clinical therapeutics 1999-03, Vol.21 (3), p.475-491
• Main Authors: Silberstein, Stephen D., Armellino, Joseph J., Hoffman, Howard D., Battikha, Jean P., Hamelsky, Sandra W., Stewart, Walter F., Lipton, Richard B.
• Format: Article
• Language: English
• Subjects: Acetaminophen - adverse effects; Acetaminophen - therapeutic use; Adolescent; Adult; Aged; Aged, 80 and over; Analgesics; Analgesics, Non-Narcotic - adverse effects; Analgesics, Non-Narcotic - therapeutic use; Anti-Inflammatory Agents, Non-Steroidal - adverse effects; Anti-Inflammatory Agents, Non-Steroidal - therapeutic use; Aspirin - adverse effects; Aspirin - therapeutic use; Biological and medical sciences; Caffeine - adverse effects; Caffeine - therapeutic use; Central Nervous System Stimulants - adverse effects; Central Nervous System Stimulants - therapeutic use; Drug Therapy, Combination; Female; Humans; Medical sciences; menstrual migraine; Menstruation; menstruation-associated migraine; Middle Aged; Migraine Disorders - drug therapy; Migraine Disorders - etiology; Neuropharmacology; nonprescription combination of acetaminophen, aspirin, and caffeine; Pharmacology. Drug treatments; Retrospective Studies
• ISSN: 0149-2918; 1879-114X
• DOI: 10.1016/S0149-2918(00)88303-4

This retrospective study sought to examine the benefits of the nonprescription combination of acetaminophen, aspirin, and caffeine (AAC; Excedrin® Migraine, Bristol-Myers Squibb Company, New York, New York) for the treatment of menstruation-associated migraine compared with migraine not associated with menses. Data were derived from 3 double-masked, randomized, placebo-controlled, singledose trials enrolling subjects who met the International Headache Society's diagnostic criteria for migraine with or without aura. Subjects with incapacitating disability (attacks requiring bed rest >50% of the time) and those who usually experienced vomiting >20% of the time were excluded. Retrospective analysis of the 1220 subjects included in the efficacyevaluable data set indicated that 185 women treated menstruation-associated migraine, 781 women treated migraine not associated with menses, and 1 woman provided no information regarding menstrual status. At baseline and at 0.5, 1, 2, 3, 4, and 6 hours postdose, subjects assessed the intensity of headache pain, functional disability, nausea, photophobia, and phonophobia. Pain intensity, nausea, photophobia, and phonophobia were rated on a 4-point scale ranging from 0 = none to 3 = severe; functional disability was rated on a 5-point scale ranging from 0 = none to 4 = incapacitating. For both menstruation-associated migraine and migraine not associated with menses, the proportion of subjects with pain intensity reduced to mild or none (responders) was significantly greater with AAC than with placebo at all postdose time points from 0.5 through 6 hours ( P ≤ 0.05), with no statistically significant difference in treatment effect between menstruation-associated migraine and migraine not associated with menses at any postdose time point. Migraine characteristics such as photophobia, phonophobia, and functional disability were significantly improved in AACtreated subjects at all time points from 1 through 6 hours ( P ≤ 0.01) in both the menstruating and nonmenstruating groups. Significant relief from nausea was experienced in both menstruation-associated migraine and migraine not associated with menses, but relief appeared earlier in the AAC nonmenstruating subjects (2 hours postdose, P ≤ 0.01) than in the menstruating subjects (6 hours postdose, P ≤ 0.05). Beginning at 3 hours postdose, significantly fewer subjects treated with AAC required rescue medication ( P ≤ 0.05) for menstruationassociated migraine (AAC 6%, placebo 15