Methods | Multicentre, randomised, double-blind, placebo-controlled, parallel-group. Single dose to treat single attack Medication administered when migraine headache pain was of moderate or severe intensity Assessments at 30, 60, and 120 minutes after dosing An open 3 mg injection of sumatriptan was available after 30 minutes if headache had not improved to no worse than mild Rescue medication (not containing ergotamine or dihydroergotamine) was available after 60 minutes if relief remained inadequate |
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Participants | Aged 18 to 60 years, meeting IHS criteria for migraine (1988) with or without aura. At least 1-year history of migraine (untreated severity ≥ moderate) with 1 to 6 attacks per month No use of ergotamine or morphine-containing preparations within 24 h, or analgesics within 6 h of study treatment The use of prophylactic therapy, provided it did not contain ergotamine, was allowed N = 685 (672 for efficacy) M 165, F 520 (76%) Mean age 40 years Without aura 76% |
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Interventions | Sumatriptan 1 mg, n = 170 Sumatriptan 2 mg, n = 171 Sumatriptan 3 mg, n = 172 Placebo, n = 172 |
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Outcomes | Efficacy data only reported for 30 minutes Adverse events Withdrawals |
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Notes | Oxford Quality Score: R1, DB1, W1. Total = 3. | |
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 | Unclear risk | Treatment groups 50 to 200 participants |