Tanew 1991.
Study characteristics | ||
Methods | RCT, placebo‐controlled, double‐blind Date of study: not stated Location: 2 centres in Austria (Vienna, Innsbruck) |
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Participants |
Randomised: 60 participants (mean age 40 years (acitretin), 49 years (placebo); 42 male) Inclusion criteria
Exclusion criteria
Dropouts and withdrawals
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Interventions |
Intervention A. Acitretin (n = 30), orally, 1 mg/kg, daily, 12 weeks or until complete clearing Control intervention B. Placebo (n = 30), orally, daily, 12 weeks Co‐intervention PUVA, phototherapy, 4 times/week, 12 weeks |
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Outcomes | Assessments at 12 weeks Primary and secondary outcomes of the trial
Outcomes of the trial
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Notes | Funding: supported by a grant from Hoffma La Roche & Co Ltd Declarations of interest: not stated |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Quote (p 682): "Only patients ... were included and assigned randomly..." Comment: no description of the method used to guarantee random sequence generation |
Allocation concealment (selection bias) | Unclear risk | Quote (p 682): "Only patients ... were included and assigned randomly..." Comment: no description of the method used to guarantee allocation concealment |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Quote (p682): "Acitretin ... or placebo..." Comment: no description of the method used to guarantee blinding of participants and personnel as acitretin leads to visible adverse effects (cheilitis) |
Blinding of outcome assessment (detection bias) All outcomes | High risk | Quote (p682): "Acitretin ... or placebo..." Comment: no description of the method used to guarantee blinding of participants and personnel as acitretin leads to visible adverse effects (cheilitis) |
Incomplete outcome data (attrition bias) All outcomes | High risk | Randomly assigned 60, analysed 48 Quote (p 683): "Of the 60 patients, 48 completed the study and were included in the statistical analysis" Comment: not ITT |
Selective reporting (reporting bias) | Unclear risk | No protocol available, no outcomes defined in the Method section |