Sang 2004.
Methods | Multicentre, randomised, triple‐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 15, 30, 45, 60, and 90 mins and 2, 3, 4, and 24 h after dosing Rescue medication (excluding ergot derivatives) was available at the participant's request after 2 h |
|
Participants | Aged 18 years or older, 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 15 attacks per month. N = 44 M 20, F 24 (55%) Mean age 40 years Without aura 89% |
|
Interventions | Sumatriptan 6 mg, n = 15 Intravenous LY293558 1.2 mg/kg, n = 13 Placebo, n = 16 (15 with moderate or severe baseline pain intensity) |
|
Outcomes | Headache relief (at 1 and 2 h) Pain‐free (at 1 and 2 h) Use of rescue medication Adverse events |
|
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) | Low risk | Allocation balanced between treatments with a block size equal to 3; randomisation code kept under lock and only accessed by pharmacist or designee |
Blinding (performance bias and detection bias) All outcomes | Low risk | Double‐dummy |
Study size | High risk | Treatment groups < 50 participants |