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 |