Efficacy of nonprescription doses of ibuprofen for treating migraine headache. A randomized controlled trial

Objective.-To evaluate the efficacy and safety of ibuprofen, 200 mg and 400 mg, compared with placebo and each other for the treatment of pain of migr aine headache. Background.-Migraine headache is a common illness with significant social a nd economic impact. Design.-Randomized, placebo-controlled, double-blind trial of 6 hours' trea tment duration. Methods.-Fifteen investigators at 17 private practice and referral centers in the United States participated in this study of 660 outpatient adults ag ed 18 to 84 years with migraine headache of moderate to severe intensity. E ach patient was randomly assigned to a single dose of study medication: ibu profen 200 mg (n = 216) or 400 mg (n = 223), or placebo (n = 221). The perc entage of patients with a reduction in baseline headache intensity from sev ere or moderate to mild or none 2 hours after treatment and the headache pa in intensity difference from baseline at 2 hours were the primary efficacy measures. Secondary outcomes included other measures of pain relief, severi ty differences from baseline for migraine-associated symptoms of nausea, ph otophobia, phonophobia, and functional disability, and percentage of patien ts with migraine-associated symptoms reduced to none. Results.-Significantly (P less than or equal to .006) more patients treated with ibuprofen, 200 mg or 400 mg, reported mild to no pain after 2 hours ( 41.7% and 40.8%, respectively), compared with those treated with placebo (2 8.1%). The mean pain intensity difference from baseline measured at 2 hours was significantly (P less than or equal to .001) greater for patients trea ted with ibuprofen 200 mg or 400 mg (0.68 and 0.65, respectively), compared with those treated with placebo (0.39). Statistically significant differen ces in favor of both doses of ibuprofen over placebo were observed for mean pain intensity difference at 1 hour after treatment. In patients with seve re baseline pain intensity, ibuprofen, 400 mg, was significantly (P less th an or equal to .048) superior to placebo for the primary efficacy end point s, while ibuprofen, 200 mg, was not. Ibuprofen, 200 mg and 400 mg, were sta tistically significantly more effective than placebo for all clinically imp ortant secondary pain relief outcomes. Mean severity changes of migraine-as sociated symptoms of nausea, photophobia, phonophobia, and functional disab ility at 2 and 6 hours were significantly (P less than or equal to .03) in favor of both doses of ibuprofen over placebo, and results for the percenta ge of patients with symptoms reduced to none consistently, although less of ten statistically significant, favored ibuprofen. No statistically signific ant differences in adverse events were found among treatment groups. Conclusions.-Ibuprofen at doses of 200 mg and 400 mg is an efficacious, cos t-effective, well-tolerated, single-ingredient nonprescription treatment fo r pain of migraine headache. In addition, while not always statistically si gnificant, ibuprofen provided a beneficial effect on associated symptoms of migraine including nausea, photophobia, phonophobia, and functional disabi lity.