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.

Design/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.

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

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, single-dose 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 > or =20% of the time were excluded.

Caffeine as an analgesic adjuvant in tension headache.

Six randomized, double-blind, two-period crossover studies, conducted under similar protocols, compared the efficacy of two analgesic combinations containing caffeine with an acetaminophen 1000 mg control and with a placebo in outpatients with episodic tension-type headaches. In four studies, comprising 1900 patients, the caffeine-containing analgesic consisted of a combination of 500 mg acetaminophen, 500 mg aspirin, and 130 mg caffeine (APAP/ASA/CAF). In two studies, comprising 911 patients, the caffeine-containing analgesic consisted of a combination of 1000 mg acetaminophen and 130 mg caffeine (APAP/CAF).