Ozyalcin 2005.
Methods | Single‐centre, double‐blind, randomised, parallel study: venlafaxine 75 mg versus venlafaxine 150 mg versus placebo | |
Participants | Country: Turkey N = 60 Sex: 6 M, 54 F Mean age: 34.25 (SD 8.28) venlafaxine 75 mg; 37.19 (SD 12.37) venlafaxine 150 mg; 38.16 (SD 11.24) placebo Diagnosis: migraine without aura according to International Headache Society (IHS 1988) Exclusion criteria: age < 18 or > 70, headache for < 2 years, < 3 attacks or > 10 attacks per month and > 15 headache days per month. Patients taking other prophylactic treatment not stopped 2 weeks prior the start of the study. Women who were breast feeding, patients with major cardiovascular, metabolic, gastrointestinal, neurologic diseases, any primary headache disorder other than migraine without aura, and any secondary headache disorder including drug over use headache disorder |
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Interventions | N = 20 venlafaxine 75 mg N = 21 venlafaxine 150 mg N = 19 placebo |
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Outcomes | 1. Number of days with headache 2. Pain intensity 3. Headache duration 4. Analgesic consumption 5. Daily activities 6. Patient satisfaction 7. Adverse events 8. Global tolerance |
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Notes | Lost at follow‐up 22% (47 completers) 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 (randomised) |
Allocation concealment (selection bias) | Unclear risk | No information |
Blinding (performance bias and detection bias) All outcomes | Unclear risk | No information (double‐blinded) |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Moderate drop‐out rate (13/60 = 21.67%), balanced (placebo 3/19 = 15.8%, venlafaxine 75 mg 5/20 = 25%, venlafaxine 150 mg 5/21 = 23.8%) |
Selective reporting (reporting bias) | Unclear risk | No information |
Other bias | High risk | Grant from Wyeth Ilaclari AS, Istanbul, Turkey. Blinded study drugs were prepared by Wyeth Pharmaceuticals, PA, USA |