Zissis 2007.
Methods | Six‐centre, randomised, double‐blind: venlafaxine XR vs placebo | |
Participants | Country: Greece N = 60. Sex: 11 male 49 female Mean age: 40.8 (SD 14.5) Diagnosis: all subtypes of tension‐type headache according to International Headache Society Criteria (IHS 2004) Exclusion criteria: patients < 18 years old, patients with headache for < 5 days/month, patients with < 21 in the Migraine Disability Assessment (MIDAS) questionnaire. No current depression or anxiety disorders |
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Interventions | N = 34 venlafaxine XR to a maximum of 150 mg/day N = 26 Placebo Active treatment: 12 weeks |
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Outcomes | 1. Number of days with headache 2. Number of hours with headache 3. Total headache intensity index (duration x severity) 4. Clinical global impression improvement |
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Notes | 40 completers, 25 venlafaxine XR, 15 placebo Adequate sample size calculation, intention‐to‐treat analysis using the last‐observation‐carried‐forward method |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Random numbers table |
Allocation concealment (selection bias) | Low risk | Sealed envelopes |
Blinding (performance bias and detection bias) All outcomes | Low risk | Venlafaxine XR and placebo were supplied as identically appearing capsules; the drug was dispensed by the hospital pharmacies |
Incomplete outcome data (attrition bias) All outcomes | High risk | High dropout rate (20/60 = 33%), unbalanced (venlafaxine XR 9/34 = 26.5%, placebo 11/26 = 42.3%) |
Selective reporting (reporting bias) | Unclear risk | No information |
Other bias | High risk | Financial support not reported but the randomisation and the blinding were done by the drug company |