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 |
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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 |
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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 | 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 |