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. 2015 Apr 1;2015(4):CD002919. doi: 10.1002/14651858.CD002919.pub3

Adly 1992.

Methods Single‐centre, double‐blind, randomised, parallel study: fluoxetine versus placebo
No control for symptomatic/analgesic medications use
Participants Country: USA
 N = 32 participants
 Sex: 3 M, 15 F (sex not reported for drop‐outs)
 Mean age: fluoxetine 34, placebo 41
 Diagnosis: migraine according to Ad hoc Committee on Classification of Headache (Ad Hoc 1962)
 Exclusion criteria: less then 1 weekly severe disabling migraine headache, concomitant medical conditions, overuse of alcohol and drugs
 Recruitment: volunteers solicited through a local newspaper and paid to participate (USD 40)
Interventions N = 16 fluoxetine to a maximum of 40 mg/day
 N = 16 placebo
Active treatment: 8 weeks
Outcomes 1. Migraine Headache Score = intensity (scale 1 to 10) * duration * amount of medications used to abort attacks
 2. Zung Depression Rating Scale
Notes 14 drop‐outs (44%):
 Fluoxetine: 7 (4 did not keep appointments, 2 for lack of efficacy,1 for side effects)
 Placebo: 7 (2 lack of efficacy, 4 changed their mind, 1 submitted an incomplete diary)
 Per protocol analysis
No sample size calculation
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk No information
Allocation concealment (selection bias) Unclear risk Prescription for fluoxetine or placebo to be filled by the hospital pharmacy
Blinding (performance bias and detection bias) 
 All outcomes Unclear risk No information
Incomplete outcome data (attrition bias) 
 All outcomes High risk High drop‐out rate (44%)
Selective reporting (reporting bias) Unclear risk No information
Other bias Unclear risk Financial support not reported
HHS Vulnerability Disclosure