Mathew 1992.
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 10, 20, 30, 40, and 50 minutes, and 1, 1.5, 2, 2.5, 4, and 4 h after dosing Rescue medication (excluding ergot‐containing drugs) were available at the discretion of the investigator beginning 1 h after dosing. Scores were adjusted for use of rescue medications by carrying the last observation (before rescue) forward. Headache relief could not be achieved if rescue medication was used. |
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Participants | Aged 18 or older, meeting IHS criteria for migraine (1988) with or without aura No use of analgesic or ergot‐containing medication within the previous 24 h (or 6 h for simple analgesics) Migraine prophylaxis was allowed N = 242 M 32, F 210 (87%) Mean age 38 years Without aura 80 % |
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Interventions | Sumatriptan 1 mg, n = 30 Sumatriptan 2 mg, n = 30 Sumatriptan 3 mg, n = 30 Sumatriptan 4 mg, n = 30 Sumatriptan 6 mg, n = 30 Sumatriptan 8 mg, n = 30 Placebo, n = 62 |
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Outcomes | Headache relief (at 1 and 2 h) Pain‐free (at 1 and 2 h) Improvement in nausea and photophobia at 1 h Use of rescue medication Adverse events |
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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 | High risk | Treatment groups < 50 participants, placebo group 50 to 200 participants |