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. 2020 Jan 9;2020(1):CD011535. doi: 10.1002/14651858.CD011535.pub3

Saurat 1988.

Study characteristics
Methods RCT, active/placebo‐controlled, double‐blind
Date of study: not stated
Location: 6 centres in France and Switzerland
Participants Randomised: 42 participants (placebo (22) mean age 43 years, 16 male; acitretin (20), mean age 46 years, 16 male)
Inclusion criteria
  • BSA > 20%


Exclusion criteria
  • Kidney insufficiency, liver insufficiency, had uncontrolled cardiovascular disorder


Dropouts and withdrawals
  • 7/65 (11%)

Interventions Intervention
A. Acitretin (n = 20), orally, 2 x 25/d 2 weeks and 25/d + UVA 3/weeks, daily, 10 weeks
Control intervention
C. Placebo, orally (n = 22), daily, 10 weeks
Co‐intervention: UVA 3/week, 10 weeks
Outcomes Assessments not clearly stated (reported at 8 weeks)
Primary outcomes of the trial
  • Not clearly stated


Outcomes of the trial
  • Change in PASI

  • Time to clear

  • AEs

Notes Funding: 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 219): "This multicenter study was performed in a double‐blind, parallel fashion... The patients were randomly allocated to ..."
Comment: no description of the method used to guarantee random sequence generation
Allocation concealment (selection bias) Unclear risk Quote (p 219): "This multicenter study was performed in a double‐blind, parallel fashion... The patients were randomly allocated to ..."
Comment: no description of the method used to guarantee allocation concealment
Blinding of participants and personnel (performance bias)
All outcomes High risk Quote (p 219): "This multicenter study was performed in a double‐blind, parallel fashion...All patients initially received 2 capsules of test medication (placebo, acitretin 2x25 mg, ...."
Comment: no description of the method used to guarantee blinding of outcome assessment with visible AEs in both acitretin and etretinate groups
Blinding of outcome assessment (detection bias)
All outcomes High risk Comment: no description of the method used to guarantee blinding of outcome assessment with visible AEs in both acitretin and etretinate groups
Incomplete outcome data (attrition bias)
All outcomes Unclear risk Quote (p 220): "Patients who left the study ... were not included in the evaluation of efficacy"
Comment: not ITT analyses (number lost to follow‐up unknown)
Selective reporting (reporting bias) Low risk Comment: no protocol was available. The prespecified outcomes mentioned in the Methods section appeared to have been reported