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. 2016 Apr 20;2016(4):CD008541. doi: 10.1002/14651858.CD008541.pub3

Summary of findings 1. Sumatriptan 50 mg or 85 mg plus naproxen 500 mg compared with placebo for migraine headache.

Sumatriptan 50 mg or 85 mg plus naproxen 500 mg compared with placebo for migraine headache
Patient or population: adults with migraine headache ‐ moderate or severe and mild baseline pain
Settings: community
Intervention: sumatriptan 50 mg or 85 mg plus naproxen 500 mg
Comparison: placebo
Outcomes Probable outcome withcomparator Probable outcome withintervention NNT or NNH(95% CI) No. of studies, attacks, events Quality of the evidence
(GRADE) Comments
Pain‐free response at 2 h for moderate to severe baseline pain 77 in 1000 280 in 1000 RR 3.7 (2.8 to 4.5)
NNT 4.9 (4.3 to 5.7)
4 studies, 2596 attacks, 462 events High Adequate numbers of studies and attacks, study quality good, consistency of response
Pain‐free response at 2 h for mild baseline pain 180 in 1000 500 in 1000 RR 2.8 (2.4 to 3.1)
NNT 3.1 (2.9 to 3.5)
8 studies, 3395 attacks, 1252 events High Adequate numbers of studies and attacks, study quality good, consistency of response
Headache relief at 2 h for moderate to severe baseline pain 270 in 1000 580 in 1000 RR 2.2 (2.0 to 2.4)
NNT 3.2 (2.9 to 3.6)
4 studies, 2596 attacks, 1107 events High Adequate numbers of studies and attacks, study quality good, consistency of response
Sustained pain‐free during the 24 h post dose for moderate to severe baseline pain 60 in 1000 200 in 1000 RR 3.4 (2.7 to 4.4)
NNT 7.9 (5.9 to 8.5)
4 studies, 2596 attacks, 339 events Moderate Adequate numbers of studies and attacks, study quality good, consistency of response. Downgraded because of threat from potential publication bias with modest effect size and modest number of events
Sustained pain‐free during the 24 h post dose for mild baseline pain 120 in 1000 370 in 1000 RR 3.0 (2.6 to 3.6)
NNT 4.1 (3.7 to 4.6)
8 studies, 3396 attacks, 907 events High Adequate numbers of studies and attacks, study quality good, consistency of response
Sustained headache relief during the 24 h post dose for moderate or severe baseline pain 160 in 1000 430 in 1000 RR 2.6 (2.3 to 3.0)
(NNT 3.8 (3.4 to 4.3)
4 studies, 2596 attacks, 768 events High Adequate numbers of studies and attacks, study quality good, consistency of response
At least 1 AE during treatment for moderate to severe baseline pain 120 in 1000 210 in 1000 RR 2.0 (1.6 to 2.4)
NNH 11 (8.3 to 15)
4 studies, 2793 attacks, 465 events Moderate Adequate numbers of studies and attacks, study quality good, consistency of response. Downgraded because of threat from potential publication bias with modest effect size
At least 1 AE during treatment for mild baseline pain 82 in 1000 140 in 1000 RR 1.5 (1.2 to 1.9)
NNH 18 (13 to 30)
6 studies, 2823 attacks, 329 events Moderate Adequate numbers of studies and attacks, study quality good, consistency of response. Downgraded because of threat from potential publication bias with modest effect size and modest number of events
Serious AE (all levels of baseline pain) No events 1 event possibly related to intervention
AE: adverse event; CI: confidence interval; NNT: number needed to treat for an additional beneficial outcome; NNH: number needed to treat for an additional harmful outcome; RR: risk ratio.
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.