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 with comparator | Probable outcome with intervention | 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. |