Bendtsen 1996.
| Methods | Single‐centre, double‐blind, randomised, three‐arm cross‐over study: citalopram vs amitriptyline vs placebo No control for symptomatic/analgesic medications use | |
| Participants | Country: Denmark
N = 40; Sex: 15 male, 25 female
Mean age 40 (range 18 ‐ 60) Diagnosis: Chronic tension‐type headache according to the International Headache Society Criteria (IHS 1988) Exclusion criteria: previous participation in a clinical trial, migraine more than 1 day a month, serious somatic or psychiatric disease including depression, intake of opiates or benzodiazepines, overuse of analgesic drug (> 2 g aspirin a day), previous treatment with antidepressant drugs Recruitment: outpatients from the Headache Clinic of Glostrup Hospital, Copenhagen |
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| Interventions | Citalopram 20 mg/day Amitriptyline to a maximum of 75 mg/day Placebo Active treatment: total of 24 weeks (3 treatment periods each of 8 weeks, with a 2‐week washout period) | |
| Outcomes | 1. Headache Index (duration * severity) 2. Headache severity (scale '0 = free condition', '5 = moderate headache', '10 = worst headache imaginable') 3. Headache duration (hours/28 days) 4. Headache frequency (days/28 days) 5. Symptomatic/analgesic drug consumption (doses/28 days) | |
| Notes | 6 dropouts (15%):
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 | Allocation sequence generated in blocks of 6 patients, method not stated |
| Allocation concealment (selection bias) | Unclear risk | No information |
| Blinding (performance bias and detection bias) All outcomes | Low risk | Drugs identical in appearance |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Moderate dropout rate, balanced, reasons fully reported |
| Selective reporting (reporting bias) | Unclear risk | No information |
| Other bias | High risk | Financial support provided by Lundbeck Foundation |