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Ibuprofen for acute migraine (new RCT)


Clinical bottom line

In a large, randomised trial in about 700 patients, done to high standards, ibuprofen 200 mg and 400 mg each had an NNT for two hour headache response of 7.5 (4.5 to 22)


JR Codispoti et al. Efficacy of nonprescription doses of ibuprofen for treating migraine headache. A randomized controlled trial. Headache 2001 41: 665-679.


This randomised controlled trial compared placebo with ibuprofen 200 mg and 400 mg in adult patients with migraine diagnosed using IHS criteria. Randomisation was computer generated, drugs were identical, and withdrawals and dropouts were described, giving it a quality score of 5/5, and making it a high quality trial.

The outcome was pain initially moderate or severe reduced to mild or none at two hours (headache response). calculations are on patients who actually took study medication.


For ibuprofen 200 mg, 91/216 (42%) had a headache response at two hours. For ibuprofen 400 mg 91/223 had a headache response at two hours. For placebo 62/221 (28%) had a headache response at two hours. The NNT for each was 7.5 (4.5 to 22).


This was a large, well conducted study done to strict criteria that make it comparable to studies done on triptans. The result was similar to others found previously for ibuprofen, in that ibuprofen was better than placebo. However, the NNT of 7.5 on nearly 700 patients was far worse than the NNT of 2.2 found in another randomised trial of only 29 patients. This demonstrates the dangers of relying on single small trials.