Adly 1992.
Methods | Single‐centre, double‐blind, randomised, parallel study: fluoxetine versus placebo No control for symptomatic/analgesic medications use |
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Participants | Country: USA N = 32 participants Sex: 3 M, 15 F (sex not reported for drop‐outs) Mean age: fluoxetine 34, placebo 41 Diagnosis: migraine according to Ad hoc Committee on Classification of Headache (Ad Hoc 1962) Exclusion criteria: less then 1 weekly severe disabling migraine headache, concomitant medical conditions, overuse of alcohol and drugs Recruitment: volunteers solicited through a local newspaper and paid to participate (USD 40) | |
Interventions | N = 16 fluoxetine to a maximum of 40 mg/day
N = 16 placebo Active treatment: 8 weeks |
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Outcomes | 1. Migraine Headache Score = intensity (scale 1 to 10) * duration * amount of medications used to abort attacks 2. Zung Depression Rating Scale | |
Notes | 14 drop‐outs (44%):
Fluoxetine: 7 (4 did not keep appointments, 2 for lack of efficacy,1 for side effects)
Placebo: 7 (2 lack of efficacy, 4 changed their mind, 1 submitted an incomplete diary)
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 | Prescription for fluoxetine or placebo to be filled by the hospital pharmacy |
Blinding (performance bias and detection bias) All outcomes | Unclear risk | No information |
Incomplete outcome data (attrition bias) All outcomes | High risk | High drop‐out rate (44%) |
Selective reporting (reporting bias) | Unclear risk | No information |
Other bias | Unclear risk | Financial support not reported |