The effectiveness of two tablets of the nonprescription combination of acetaminophen, aspirin, and caffeine in alleviating migraine headache pain was evaluated in 1357 patients (mean age, 36 years) from several centers, enrolled in three double-blind, single-dose, placebo-controlled studies. Pain intensity was significantly reduced within 1 to 6 hours after receiving the combination when compared with the effect of placebo. Within 2 hours, pain was reduced to mild or none in 60% of drug-treated patients compared to 30% of controls; and at 6 hours, 50% were pain free compared to 23% of controls. Associated symptoms, nausea, photophobia, phonophobia, and functional disability, were also significantly improved. Adverse experiences, occurring in 13% of drug-treated compared to 7% of placebo controls, included nausea (5%), nervousness (4%), dizziness (3%), and gastrointestinal symptoms (3%). 
COMMENT. The nonprescription combination of acetaminophen, aspirin, and caffeine is a safe, cost-effective, treatment for adults with migraine, and this alternative therapy should be indicated also in children and adolescents.