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

Polisca 1992.

Methods Single‐centre, double‐blind, randomised, parallel study: fluoxetine versus placebo
 No control for symptomatic/analgesic medications use
Participants Country: Italy
 N = 60
 Sex: 22 M, 38 F
 Mean age: 43.5 (SD 2.1) fluoxetine; 39 (SD 0.8) placebo
 Diagnosis: transformed migraine (chronic daily migraine headache, according to Manzoni and Nappi (Nappi 1985), with a 6‐year or longer history)
 Exclusion criteria: unclear
 Recruitment: no information provided
Interventions N = 30 fluoxetine 20 mg/day
 N = 30 placebo
Active treatment: 12 weeks
Outcomes 1. Pain Total Index (not defined)
 2. Migraine Index (not defined)
 3. Frequency (number of headache days/30 days)
 4. Symptomatic/analgesic drug consumption
Notes No drop‐outs
 Article in Italian
The report omits important details
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 No information
Blinding (performance bias and detection bias) 
 All outcomes Unclear risk Neither doctors nor patients were able to foresee the assignment (not specified how)
Incomplete outcome data (attrition bias) 
 All outcomes Low risk No drop‐outs
Selective reporting (reporting bias) Unclear risk No information
Other bias Unclear risk Financial support not reported