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 |
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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 |
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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 |