Naproxen for Acute Migraine Headaches in Adults

Summary

A Cochrane review [Abstract] 1 included 6 RCTs with a total of 735 patients with migraine. Studies were multicentre and diagnosed migraine according to IHS criteria. Individuals with frequent migraine headaches (>6 to 8 attacks per month) were excluded. In all studies, participants self treated their headaches at home. The mean age of patients ranged from 40 to 42 years, from 81% to 91% of them were female. Naproxen 275 mg, 500 mg, or 825 mg were used to treat migraine attacks of moderate or severe pain intensity. All placebo-controlled studies treated a single attack with a single dose of study medication, while the active-controlled studies treated multiple attacks over a 12-week period, each with a single dose of study medication. Overall, 1241 participants took naproxen (275 mg to 825 mg), 229 took sumatriptan 50 mg, 173 took naratriptan 2.5 mg, and 1092 took placebo. No studies combined naproxen with an antiemetic. Studies using naproxen 275 mg provided no usable data for analysis. Naproxen (500 mg and 825 mg) was better than placebo for pain-free response and headache relief. At two hours, the NNT for pain-free response was 11 (95% CI 8.7 to 17; 4 studies, 2149 attacks) (17% response with naproxen, 8% with placebo; risk ratio 2.0 (1.6 to 2.6) and for headache relief 6.0 (4.8 to 7.9; 4 studies, 2149 attacks) (45% response with naproxen, 29% with placebo; risk ratio 1.6 (1.4 to 1.8). The NNT for sustained pain-free response during the 24 hours post dose was 19 (13 to 34; 4 studies, 2149 attacks) (12% response with naproxen, 6.7% with placebo), and for sustained headache relief during the 24 hours post dose was 8.3 (6.4 to 12; 4 studies, 2149 attacks) (30% response with naproxen, 18% with placebo). Analysing only the lower dose of 500 mg of naproxen did not significantly change the results. Adverse events, which were mostly mild or moderate in severity and rarely led to withdrawal, were more common with naproxen than with placebo when the 500 mg and 825 mg doses were considered together, but not when the 500 mg dose was analysed alone.