Oguzhanoglu 1999.
Methods | Single‐centre, open‐label randomised, parallel study: fluoxetine vs amitriptyline No control for symptomatic/analgesic medications use | |
Participants | Country: Turkey
Overall: N = 52; Sex: 6 male, 41 female (sex not reported for dropouts). Chronic tension‐type headache and episodic tension‐type headache groups: N = 35; Sex: 3 male, 29 female (sex not reported for dropouts); mean age: 38.5 chronic tension‐type headache, 31.5 episodic tension‐type headache Diagnosis: migraine (n = 17), chronic tension‐type headache (n = 14) and episodic tension‐type headache (n = 21), all defined according to International Headache Society Criteria (IHS 1988) Exclusion criteria: antidepressant 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 |
|
Outcomes | 1. Headache frequency (number of days with headache/30 days) 2. Pain intensity (not defined) 3. Headache duration (not defined) | |
Notes | Overall, 5 dropouts (10%) for side effects, three in the chronic tension‐type headache and episodic tension‐type headache groups Per protocol analysis. 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 | High risk | Open‐label |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Low dropout rate (3/35, 8.6%), reasons reported |
Selective reporting (reporting bias) | Unclear risk | No information |
Other bias | Unclear risk | Financial support not reported |