Ferrari 1991.

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 1, 2, and 24 h after dosing Second blinded and re‐randomised dose of study medication available if, after 1 h, the patient was not completely pain‐free Rescue medication (excluding ergotamine and dihydroergotamine) available after 2 h if symptoms were not improved at this time
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 a maximal frequency of 6 attacks per month. No prophylaxis for migraine within 2 weeks, ergot‐containing preparations within 24 h, or simple analgesics/NSAIDs within 6 h of taking study medication N = 639 (636 for efficacy) M 118, F 521 (82%) Mean age 40 years Without aura 70%
Interventions	Sumatriptan 6 mg, n = 423 (422 for efficacy) Sumatriptan 8 mg, n = 110 (109 for efficacy) Placebo, n = 106 (105 for efficacy)
Outcomes	Headache relief (at 1 h) and 2 h (1 h after optional 2nd dose) Pain‐free (at 1 h)
Notes	Oxford Quality Score: R2, DB2, W1. Total = 5.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Computer‐generated randomisation code
Allocation concealment (selection bias)	Low risk	Patients were entered in ascending sequential order at each centre
Blinding (performance bias and detection bias) All outcomes	Low risk	Placebo was supplied in matching ampoules containing isotonic saline solution
Study size	Unclear risk	One treatment group > 200 participants, other treatment and placebo group 50 to 200 participants