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

Krymchantowski 2002.

Methods Single‐centre, double‐blind, randomised, parallel study: amitriptyline versus amitriptyline plus fluoxetine
 Control for symptomatic/analgesic medications use
Participants Country: Brazil
 N = 39
 Sex: 13 M, 26 F
 Mean age: 36.4 (SD 2.5)
 Diagnosis: transformed migraine with overusing symptomatic medications (according criteria proposed by Silberstein 1996)
 Exclusion criteria: patients using medications for migraine prophylaxis or chronic treatment for other clinical and psychiatric conditions, women of childbearing potential not using contraceptives
 Recruitment: no information provided
Interventions N = 19 amitriptyline to a maximum of 40 mg/day
 N = 20 amitriptyline to a maximum of 40 mg/day plus fluoxetine to a maximum of 40 mg/day
Active treatment: 9 weeks
Outcomes 1. Headache Index = frequency (number of headache days/30 day) x intensity ('0 = no headache' to '4 = bed rest')
Notes 12 drop‐outs (31%):
 Amitriptyline: 6 (4 for incomplete diary, 2 for worsening condition)
 Amitriptyline plus fluoxetine: 6 (3 for incomplete diary, 1 for worsening condition, 2 for side effects)
 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 Drugs identical in appearance
Incomplete outcome data (attrition bias) 
 All outcomes Low risk Moderate drop‐out rate, balanced, reasons fully reported
Selective reporting (reporting bias) Unclear risk No information
Other bias Low risk No financial support provided by drug companies