Diener 1999.
Methods | Multicentre, randomised, double‐blind, double‐dummy, placebo‐controlled, parallel‐group. Single dose to treat single attack. Medication administered when migraine headache pain was of moderate or severe intensity Assessment at 0.5, 1, 1.5, and 2 h after dosing Rescue medication available after 2 h |
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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 2 to 6 attacks per month. No analgesics or migraine drugs within 24 h of study medication administration. No use of compound analgesics, sumatriptan, ergotamine tartrate, DHE, codeine, or barbiturates for more than 10 days per month prior to screening. N = 278 (275 for efficacy) M 55, F 220 (80%) Mean age 41 years Without aura 67% |
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Interventions | Sumatriptan 6 mg, n = 114 Intravenous acetylsalicylic acid lysinate 1.8 g, n = 119 Placebo, n = 42 |
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Outcomes | Headache relief (at 1 and 2 h) Pain‐free (at 2 h) Improvement in nausea, vomiting, photophobia, and phonophobia at 2 h Use of rescue medication Adverse events Withdrawals |
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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 | Double‐dummy |
Study size | High risk | Treatment groups 50 to 200 participants, placebo group < 50 participants |