Summary of findings 1. Naproxen 500 mg or 825 mg compared with placebo for migraine headache.

Naproxen 500 mg or 825 mg compared with placebo for migraine headache
Patient or population: migraine headache ‐ moderate or severe pain Settings: community Intervention: naproxen 500 mg or 825 mg Comparison: placebo
Outcomes	Probable outcome with comparator	Probable outcome with intervention	NNT or NNH and/or relative effect (95% CI)	No of studies, attacks, events	Quality of the evidence (GRADE)	Comments
Pain‐free response at 2 h	80 in 1000	170 in 1000	NNT 11 (8.7 to 17)	4 studies, 2149 attacks, 275 events	Moderate1	Lower NNTs are better than higher NNTs
Headache relief at 2 h	290 in 1000	450 in 1000	NNT 6.0 (4.8 to 7.9)	4 studies, 2149 attacks, 793 events	Moderate1	Lower NNTs are better than higher NNTs
Sustained pain‐free during the 24 h post dose	70 in 1000	120 in 1000	NNT 19 (13 to 34)	4 studies, 2149 attacks, 202 events	Moderate1	Lower NNTs are better than higher NNTs
Sustained headache relief during the 24 h post dose	180 in 1000	300 in 1000	NNT 8.3 (6.4 to 12)	4 studies, 2149 attacks, 505 events	Moderate1	Lower NNTs are better than higher NNTs
At least one AE	120 in 1000	150 in 1000	NNH 28 (15 to 130)	4 studies, 2174 attacks, 293 events	Low2	Higher NNHs are better than lower NNTs
Serious AE	Insufficient data					‐
AE: adverse event; CI: confidence interval; NNT: number needed to treat; NNH: number needed to harm. Note: NNT or NNH is reported when an outcome is statistically different from placebo or comparator. Where the result is not statistically different, a risk ratio or similar outcome is reported.
GRADE Working Group grades of evidence High quality: Further research is very unlikely to change our confidence in the estimate of effect. Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate. Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate. Very low quality: We are very uncertain about the estimate.

1 ‐ Quality of evidence downgraded from high because of threat from potential publication bias with modest effect size and numbers of events.

2 ‐ Quality of evidence downgraded from high because of threat from potential publication bias with modest effect size and numbers of events, combined with inconsistent reporting of the outcome.