EFFICACY AND SAFETY OF ACETAMINOPHEN, ASPIRIN, AND CAFFEINE IN ALLEVIATING MIGRAINE HEADACHE PAIN - 3 DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED TRIALS

Objective: To assess the effectiveness of the nonprescription combinat ion of acetaminophen, aspirin, and caffeine in alleviating migraine he adache pain. Design: Three double-blind, randomized, parallel-group, s ingle-dose, placebo-controlled studies. Setting: Private practice, ref erral centers, and general community. Patients: Migraineurs with moder ate or severe head ache pain who met International Headache Society di agnostic criteria for migraine with aura or without aura. The most sev erely disabled segment of migraineurs, including those whose attacks u sually required bed rest, or who vomited 20% or more of the time, were excluded. Of the 1357 enrolled patients, 1250 took study medication a nd 1220 were included in the Efficacy-evaluable data set. Intervention : Two tablets of the nonprescription combination of acetaminophen, asp irin, and caffeine or placebo taken orally as a single-dose treatment of 1 eligible acute migraine attack. Main Outcome Measures: Pain inten sity difference from baseline; percentage of patients with pain reduce d to mild or none. Results: Significantly greater reductions in migrai ne headache pain intensity 1 to 6 hours after dose were seen in patien ts taking the acetaminophen, aspirin, and caffeine combination than in those taking placebo in each of the 3 studies. Pain intensity was red uced to mild or none 2 hours after dose in 59.3% of the 602 drug-treat ed patients compared with 32.8% of the 618 placebo-treated patients (P <.001; 95% confidence interval [CI], 55%-63% for drug, 29%-37% for pla cebo); at 6 hours after dose, 79% vs 52%, respectively, had pain reduc ed to mild or none (P<.001; 95% CI, 75%-82% vs 48%-56%). In addition, by 6 hours after close, 50.8% of the drug-treated patients were pain f ree compared with 23.5% of the placebo-treated patients (P<.001; 95% C I, 47%-55% for drug, 20%-27% for placebo). Other migraine headache cha racteristics, such as nausea, photophobia, phonophobia, and functional disability, were significantly improved 2 to 6 hours after treatment with the acetaminophen, aspirin, and caffeine combination compared wit h placebo (P less than or equal to.01). Conclusions: The nonprescripti on combination of acctaminophen, aspirin, and caffeine was highly effe ctive for the treatment of migraine headache pain as well as for allev iating the nausea, photophobia, phonophobia, and functional disability associated with migraine attacks. This drug combination also has an e xcellent safety profile and is well tolerated.