Ruzicka 1990.
Study characteristics | ||
Methods | RCT, placebo‐controlled, double‐blind Date of study: December 1986 ‐ March 1988 Location: 7 centres in Germany |
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Participants |
Randomised: 82 participants (mean age 44 years, 55 male) Inclusion criteria
Exclusion criteria
Dropouts and withdrawals
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Interventions |
Intervention A. Acitretin, orally, 35 mg, daily, 8 weeks (n = 42) Control intervention B. Placebo, orally, daily, 8 weeks (n = 40) |
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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 sources: not stated 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 483): "The study was designed as a randomized, double‐blind, placebo‐controlled parallel group trial" Comment: no description of the method used to guarantee random sequence generation |
Allocation concealment (selection bias) | Unclear risk | Quote (p 483): "The study was designed as a randomized, double‐blind, placebo‐controlled parallel group trial" Comment: no description of the method used to guarantee allocation concealment |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Quote (p 483): "The study was designed as a randomized, double‐blind, placebo‐controlled parallel group trial" Comment: no description of the method used to guarantee blinding as visible side effects are related to acitretin |
Blinding of outcome assessment (detection bias) All outcomes | High risk | Quote (p 483): "The study was designed as a randomized, double‐blind, placebo‐controlled parallel group trial... the investigators blinded to treatment assignment" Comment: no description of the method used to guarantee blinding of outcome assessment as visible side effects are related to acitretin |
Incomplete outcome data (attrition bias) All outcomes | Low risk | 82 included/78 analysed Quote (p 483): "... according to the intention‐to‐treat principle.. Dropout data were evaluated on the date of dropout" Comment: probably done |
Selective reporting (reporting bias) | Unclear risk | Comment: no protocol was available. The prespecified outcomes mentioned in the Methods section appeared to have been reported |