Oguzhanoglu 1999.
Methods | Single‐centre, open‐label, randomised, parallel study: fluoxetine versus amitriptyline No control for symptomatic/analgesic medications use | |
Participants | Country: Turkey Overall: N = 52; Sex: 6 M, 41 F (sex not reported for drop‐outs) Migraine group: N = 17; Sex: 3 M, 12 F (sex not reported for drop‐outs); mean age: 31 Diagnosis: migraine (N = 17), CTTH (N = 14) and ETTH (N = 21), all defined according to International Headache Society criteria (IHS 1988) Exclusion criteria: antidepressants use in the previous year, score > 17 Hamilton Depression Scale Recruitment: from November 1996 to September 1997, no other information | |
Interventions | N = 22 amitriptyline to a maximum of 50 mg/day
N = 25 fluoxetine 20 mg/day Duration of active treatment: unclear |
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Outcomes | 1. Headache frequency (number of days with headache/30 days) 2. Pain intensity (not defined) 3. Headache duration (not defined) | |
Notes | Overall, 5 drop‐outs (10%) for side effects (2 in the migraine group)
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 | High risk | Open label |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Moderate drop‐out rate (2/17, 11.7%), reasons reported |
Selective reporting (reporting bias) | Unclear risk | No information |
Other bias | Unclear risk | Financial support not reported |