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
Baseline data: randomised to etretinate 1 mg/kg once daily (n = 24) or placebo (n = 26)
Withdrawal: etretinate (n = 4); placebo (n = 5)
|
|
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
|
|
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Incomplete outcome data (attrition bias) All outcomes | High risk | Quote: "9 patients withdrawn during trial were used in analyses of side effects only: etretinate (4); placebo (5)
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 |