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

Tanew 1991.

Study characteristics
Methods RCT, placebo‐controlled, double‐blind
Date of study: not stated
Location: 2 centres in Austria (Vienna, Innsbruck)
Participants Randomised: 60 participants (mean age 40 years (acitretin), 49 years (placebo); 42 male)
Inclusion criteria
  • Participants with moderate‐severe psoriasis (BSA ≥ 20), age ≥ 18 years


Exclusion criteria
  • Not stated


Dropouts and withdrawals
  • 12/60 (20%)

  • Time and reasons:

    • acitretin group (7): severe muscle pain (1), serum triglycerides exceeding 400 mg/dL (2), irregular drug intake (4)

    • placebo group (5): unrelated to therapy

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
Outcomes Assessments at 12 weeks
Primary and secondary outcomes of the trial
  • Not defined


Outcomes of the trial
  • Complete remission

  • Side effects

Notes Funding: supported by a grant from Hoffma La Roche & Co Ltd
Declarations of interest: not stated
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