Steiner 1998.

Methods	Multi‐centre, double‐blind, randomised, parallel study: S‐fluoxetine versus placebo. Control for symptomatic/analgesic medications use
Participants	Country: United Kingdom N = 53 Sex: 13 M, 40 F Mean age: 37.5 S‐fluoxetine, 39 placebo Diagnosis: migraine (according to International Headache Society Criteria, IHS 1988) with a 1‐year or longer history and 6 to 18 attacks reported in the previous 3 months Exclusion criteria: patient using medications for migraine prophylaxis or chronic treatment for depression, breast feeding and pregnancy, drug or alcohol abuse, participation in previous trials Recruitment: 3 headache centres in the London region. Patients stratified at each centre according to historical attack frequency
Interventions	N = 27 S‐fluoxetine 40 mg/day N = 26 placebo Active treatment: 12 weeks
Outcomes	Primary efficacy measures: 1. Headache frequency (attacks/28 days) Secondary efficacy measures: 2. Migraine days/28 days 3. Attack intensity (rating scale from '1 = mild attack' to '3 = severe') 4. Symptomatic/analgesic drug consumption (dose/attack) 5. Patient's Global Impression of Disease intensity (0 to 100 mm visual analogue scale)
Notes	65 patients recruited, 53 randomised 20 (38%) drop‐outs: 3 for non‐adherence to treatment S‐fluoxetine: 9 (4 for side effects; 1 for inadequate response; 4 reason not specified) Placebo: 8 (4 for side effects, 1 for inadequate response, 3 reason not specified) Per protocol analysis Sample size calculation done, drop‐out rate higher than expected
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	No information
Allocation concealment (selection bias)	Unclear risk	No information
Blinding (performance bias and detection bias) All outcomes	Low risk	Drugs identical in appearance
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	Substantial drop‐out rate, balanced, reason fully reported
Selective reporting (reporting bias)	Unclear risk	No information
Other bias	High risk	Financial support provided by Sepracor Inc. (Marlborough, MA, USA)