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. 2021 Apr 19;2021(4):CD011535. doi: 10.1002/14651858.CD011535.pub4

Ruzicka 1990.

Study characteristics
Methods RCT, placebo‐controlled, double‐blind
Date of study: December 1986 ‐ March 1988
Location: 7 centres in Germany
Participants Randomised: 82 participants (mean age 44 years, 55 male)
Inclusion criteria
  • Aged 18 ‐ 75

  • Generalised chronic plaque or exanthematic


Exclusion criteria
  • Pregnancy, kidney insufficiency, liver insufficiency

  • Had uncontrolled cardiovascular disorder

  • Had uncontrolled diabetes

  • Had uncontrolled hypertension


Dropouts and withdrawals
  • 4/82 (5%)

  • Acitretin (2) overweight and dyslipidaemia

  • Placebo (2) erythrodermia

Interventions Intervention
A. Acitretin, orally, 35 mg, daily, 8 weeks (n = 42)
Control intervention
B. Placebo, orally, daily, 8 weeks (n = 40)
Outcomes Assessments at 8 weeks
Primary outcomes of the trial
  • PASI


Secondary outcomes of the trial
  • Side effects

Notes Funding sources: not stated
Declarations of interest: not stated
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