Methods | Multicentre, randomised, double-blind, placebo-controlled, cross-over design. Single dose to treat each of 2 successive attacks Assessments at 1 and 2 h after dosing. Second dose of study medication available after 2 h for participants not completely free from headache, or experiencing recurrence of headache within 24 h Rescue medication (non-ergotamine) was available 1 h after second injection if symptom relief remained inadequate |
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Participants | Aged 18 to 65, with GP diagnosed migraine. At least 6-month history of migraine (untreated severity ≥ moderate) with an average of 1 to 6 attacks per month Participants were excluded if they had previously used sumatriptan or were currently using migraine prophylactic agents N = 230 (209 treated both attacks) M 20, F 189 (90%) Mean age 44 years Post-treatment headache diagnosis revealed that ≥ 90% of treated attacks met IHS criteria for migraine (1988) with or without aura Without aura 65% Approximately 1% of participants had mild baseline pain intensity when study medication was administered |
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Interventions | Sumatriptan 6 mg, n = 209 Placebo, n = 209 |
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Outcomes | Adverse events | |
Notes | Oxford Quality Score: R1, DB1, W0. Total = 2. | |
Risk of bias | ||
Bias | Authors’ judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Not reported |
Allocation concealment (selection bias) | Unclear risk | Not reported |
Blinding (performance bias and detection bias) All outcomes |
Unclear risk | Not reported |
Study size | Low risk | Treatment groups > 200 participants |