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. 2020 Jan 20;2020(1):CD011628. doi: 10.1002/14651858.CD011628.pub2

Foged 1983.

Methods Double‐blind, randomised, parallel‐arm trial
Multi‐centre
Period of inclusion: winter 1980 to 1981
Participants Inclusion criteria
Not stated
Exclusion criteria
  • Pregnancy

  • Methotrexate or PUVA therapy in the last 4 weeks


Baseline data: randomised to etretinate 1 mg/kg once daily (n = 24) or placebo (n = 26)
  • Median age (range), years: 55 (26 to 78)

  • Male/female: 8/42

  • Median duration of condition (range), years: 3 (0 to 30)

  • Proportion of participants with psoriatic lesions elsewhere: not specified


Withdrawal: etretinate (n = 4); placebo (n = 5)
  • Adverse events: 2; 0

  • Reasons unrelated to treatment: 3

  • Lack of effect: 0; 4

Interventions Intervention
A: etretinate 1 mg/kg once daily (24 participants)
Control intervention
B: placebo (26 participants)
Co‐interventions: none
Duration of treatment: 8 weeks
Outcomes No primary or secondary outcome pre‐specified
  • Response using an ordinal scale

  • Adverse events

Notes Funding: not reported
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Quote: "After informed consent, 24 patients were allocated to 8 weeks of oral etretinate treatment and 26 patients to placebo"
Comment: insufficient information about the sequence generation process to permit judgement
Allocation concealment (selection bias) Unclear risk Comment: unclear because the method of concealment is not described
Blinding of participants and personnel (performance bias) 
 All outcomes High risk Quote: "double‐blind"
Comment: likely that blinding could have been broken because of etretinate's side effects, mainly symptoms from skin and/or nasobuccal mucous membranes
Blinding of outcome assessment (detection bias) 
 All outcomes High risk Quote: "double‐blind"
Comment: likely that blinding could have been broken because of etretinate's side effects, mainly symptoms from skin and/or nasobuccal mucous membranes
Incomplete outcome data (attrition bias) 
 All outcomes High risk Quote: "9 patients withdrawn during trial were used in analyses of side effects only:
etretinate (4); placebo (5)
  • Adverse events: 3; 0

  • Did not fulfil selection criteria: 1; 0

  • Transfered to operation: 0; 1

  • Inefficacy: 0; 4"


Comment: 20% of missing data with unbalanced reason by group; not specified how study authors dealt with it
Selective reporting (reporting bias) Unclear risk Comment: no protocol found to guarantee that all planned outcomes are presented in the results