Summary of findings 4. Should sumatriptan plus naproxen sodium be used to treat adolescents with migraine?
| Sumatriptan + naproxen sodium compared with placebo in adolescents with migraine | ||||||
| Patient or population: acute treatment of migraine in adolescents Setting: ambulatory Intervention: sumatriptan + naproxen sodium Comparison: placebo | ||||||
| Outcomes | Anticipated absolute effectsa (95% CI) | Relative effect (95% CI) | No of participants (studies) | Quality of the evidence (GRADE) | Comments | |
| Response with placebo | Response with Sumatriptan + naproxen sodium | |||||
| Pain freedom at 2 h | Study population | RR 2.66 (1.57 to 4.51) | 485 (1 RCT) | ⨁⨁⨁◯b,c MODERATE | Doses including sumatriptan + naproxen 10 mg + 60 mg, 30 mg + 180 mg, and 85 mg + 500 mg were all well tolerated and demonstrated similar efficacy | |
| 99 per 1000 | 262 per 1000 (163 to 394) | |||||
| Adverse events | 83 per 1000 | 2 per 1000 (− 2 to 7) |
RD 0.03 (− 0.02 to 0.09) |
490 (1 RCT) |
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GRADE Working Group grades of evidence
High quality: We are very confident that the true effect lies close to that of the estimate of the effect.
Moderate quality: We are moderately confident in the effect estimate: the true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different.
Low quality: Our confidence in the effect estimate is limited: the true effect may be substantially different from the estimate of the effect.
Very low quality: We have very little confidence in the effect estimate: the true effect is likely to be substantially different from the estimate of effect. CI: confidence interval; RR: risk ratio; RD: risk difference. | ||||||
aThe response in the intervention group (and its 95% confidence interval) is based on the assumed response in the comparison group and the relative effect of the intervention (and its 95% CI). bThe confidence interval of the effect size is wide. The true effect may be substantially different than the estimated effect in producing pain freedom.
cHigh (⨁⨁⨁⨁) = further research is very unlikely to change our confidence in the estimate of effect; Moderate (⨁⨁⨁◯) = further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate; Low (⨁⨁◯◯) = 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 (⨁◯◯◯) = any estimate of effect is very uncertain.