A combination of acetaminophen, aspirin and caffeine is more effective than ibuprofen for treating acute migraine pain, according to results of a head-to-head clinical trial.

The combination, which is sold over-the-counter as Excedrin Migraine, relieved pain more effectively and more quickly than ibuprofen, Dr. Jerome Goldstein of the San Francisco Headache Clinic and colleagues report in the March issue of Headache. Both drugs were more effective than placebo.

The findings support recent recommendations of the U.S. Headache Consortium and the German Migraine Headache Society, the researchers note. Both groups recommended acetaminophen, aspirin plus caffeine as first-line treatment for mild-to-moderate migraine and tension-type headache.

Fifty-seven percent of migraineurs treat themselves with other-the-counter medications, Goldstein and his team note. To date, no study has compared such medications for migraine treatment.

To investigate, the researchers randomized 1,555 migraineurs to a single dose of two tablets each containing 250 mg acetaminophen, 250 mg aspirin and 65 mg caffeine; 200 mg ibuprofen; or placebo.

Meaningful pain relief occurred at 128.4 minutes post-dose with acetaminophen/aspirin/caffeine; 147.9 minutes with ibuprofen; and 167.1 with placebo.

Two, three and four hours post-dose, pain relief scores were higher with the triple therapy than with ibuprofen and placebo.

The combination of acetaminophen/aspirin/caffeine outperformed placebo for pain relief beginning at 45 minutes post-dose, and remained significantly more effective throughout the study. Ibuprofen pain relief scores exceeded placebo beginning at 90 minutes post-dose.

Significantly more patients in the ibuprofen and placebo groups required rescue medication at two hours post-dose compared to the other group. Adverse events with both drugs were mild, and included nervousness and nausea more frequently with acetaminophen/aspirin/caffeine and sleepiness more frequently with ibuprofen.

“These findings have important implications for medical professionals and their patients,” Goldstein and his colleagues write. “For the first time, rigorous data show that OTC (over-the-counter) medications are safe and effective in an unrestricted migraine patient population, and that there are significant differences between the two approved OTC migraine therapies.”

SOURCE: Headache March 2006.