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

Landy 1999.

Methods Single‐centre, double‐blind, randomised, parallel study: sertraline versus placebo
 No control for symptomatic/analgesic medications use
Participants Country: USA
 N = 27
 Sex: 2 M, 25 F
 Mean age: 36 (SD 8.6)
 Diagnosis: migraine with or without aura for 1 year or longer (according to International Headache Society Criteria, IHS 1988)
 Exclusion criteria: severe systemic illness, pregnancy, lactation, treated for a concomitant seizures or psychiatric disorder
 Recruitment: patients of the Wesley Headache Clinic
Interventions N = 13 sertraline to a maximum of 100 mg/day
 N = 14 placebo
Active treatment: 8 weeks
Outcomes 1. Headache Index = intensity ('1 = mild pain' to '3 = severe') x number of occurrences
 2. Impairment Index = impairment ('1 = no impairment' to '3 = bed rest') * number of occurrences
Notes 11 drop‐outs (41%):
 Sertraline: 7 (6 did not complete the study, 1 for side effects: loss of appetite and insomnia)
 Placebo: 4 (2 did not return, 2 for side effects: anxiety, nausea, dizziness and sweating)
 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 No information
Blinding (performance bias and detection bias) 
 All outcomes Low risk Patient, treating physician, and nurse were unaware of the group assignment
Incomplete outcome data (attrition bias) 
 All outcomes High risk Substantial drop‐out rate, unbalanced, reasons not fully reported
Selective reporting (reporting bias) Unclear risk No information
Other bias Unclear risk Financial support not reported
HHS Vulnerability Disclosure