Akcali 2014.
Study characteristics | ||
Methods | RCT, active‐controlled, open‐label trial Date of study: January 2008 ‐ January 2009 Location: Gaziantep, Turkey (1 centre) |
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Participants |
Randomised: 55 participants (mean age 39 years, 33 male) Inclusion criteria
Exclusion criteria None Dropouts and withdrawals
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Interventions |
Intervention A. Acitretin (n = 25), orally, 0.3 ‐ 0.5 mg/kg/d Control intervention B. Cyclosporin (n = 21), orally, 3 mg/kg/d |
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Outcomes | Assessment at 8 weeks Primary outcome of the trial
Outcomes of the trial
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Notes | Funding source: Quote (p 1121): "No specific grant" Declarations of interest: Quote (p 1121): "The authors declare that there are no conflicts of interest." |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote (p1119): "Patients were stratified into one of two groups via a computer‐generated randomisation schedule" Comment: probably done |
Allocation concealment (selection bias) | Unclear risk | Comment: no description of the method used to guarantee allocation concealment |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Comment: not stated that it was a blinded trial. Acitretin has visible side effects (muco cutaneous dryness) |
Blinding of outcome assessment (detection bias) All outcomes | High risk | Comment: no independent assessor. Not stated that it was a blind trial. Acitretin has visible side effects. |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Randomly assigned 55, analysed 46 Management of missing data: not stated |
Selective reporting (reporting bias) | High risk | Comment: no primary or secondary outcomes stated. No protocol available |