Dahlof 1992.
Methods | Single‐centre, randomised, double‐blind, placebo‐controlled, within‐patient cross‐over. Each participant treated 2 successive attacks with a single dose of one or other study medication. Medication administered when migraine headache pain was of moderate or severe intensity Assessments at 0.5, 1, 1.5, and 2 h after dosing Rescue medication (not ergotamine) was available after 2 h for inadequate relief of symptoms |
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Participants | Aged 18 to 65 years, meeting IHS criteria for migraine (1988) with or without aura. At least 1‐year history of migraine (untreated severity ≥ moderate) with an average of 1 to 6 attacks per month. Use of migraine prophylactic therapy was stopped at least 2 weeks before receipt of study medication. No ergotamine‐containing preparations within 24 h, and no analgesics within 6 h of taking study medication. Minimum of 48 h between treated attacks N = 27 M 5, F 22 (81%) Mean age 45 years Proportion with/without aura not reported |
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Interventions | Sumatriptan 8 mg, n = 27 Placebo, n = 27 |
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Outcomes | Headache relief (at 1 and 2 h) Pain‐free (at 2 h) Use of rescue medication Presence of functional disability (at 1 and 2 h) |
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Notes | Oxford Quality Score: R1, DB2, W0. 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 | Low risk | Matching placebo |
Study size | High risk | Treatment groups < 50 participants |