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, 90, and 120 minutes after dosing Rescue medication was available after 30 minutes if there was no response to the study treatment |
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Participants | To be eligible for entry, participants were required to have a history of migraine (1 to 6 headaches a month) with or without aura as defined by the IHS (1988) No narcotic analgesics or ergotamine within the previous 24 h, or aspirin within the previous 6 h before study treatment N= 51 (50 for efficacy) M 7, F 43 (86%) Mean age 41 years Without aura 74% |
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Interventions | Sumatriptan 4 mg, n = 28 Placebo, n = 23 (22 for efficacy) |
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Outcomes | Only 30 minute efficacy outcomes reported Adverse events |
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Notes | Oxford Quality Score: R1, DB2, W1. Total = 4. | |
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 |
Low risk | Matching placebo |
Study size | High risk | Treatment groups <50 participants |