Olsen 1989.
Study characteristics | ||
Methods | RCT, placebo‐controlled, double‐blind trial Date of study: not stated Setting: not stated |
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Participants |
Randomised: 15 participants, age range 23 ‐ 72 years, 11 male Inclusion criteria
Exclusion criteria
Dropouts and withdrawals
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Interventions |
Intervention A. Acitretin (n = 10), orally, 25/50 mg, daily, 8 weeks Control intervention B. Placebo (n = 5), orally, daily, 8 weeks |
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Outcomes | Assessments at 8 weeks Primary outcomes of the trial
Secondary outcomes of the trial
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Notes | Funding by Hoffman‐La Roche Inc 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 681): "Patients were assigned to... in a random, double‐blind fashion" Comment: no description of the method used to guarantee random sequence generation |
Allocation concealment (selection bias) | Unclear risk | Quote (p 681): "Patients were assigned to... in a random, double‐blind fashion" Comment: no description of the method used to guarantee allocation concealment |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Quote (p 681): "Patients were assigned to... in a random, double‐blind fashion" Comment: visible adverse effects of acitretin such as cheilitis were visible |
Blinding of outcome assessment (detection bias) All outcomes | High risk | Quote (p 681): "Patients were assigned to... in a random, double‐blind fashion" Comment: visible adverse effects of acitretin such as cheilitis were visible |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | 15 included / Number of participants analysed not stated Comment: no description of the methods used to perform the efficacy analyses and to manage the missing data |
Selective reporting (reporting bias) | Unclear risk | Comment: no protocol was available. The prespecified outcomes mentioned in the Methods section were reported |