Lassus 1983.
Methods | Randomised, parallel‐arm trial Number of centres not stated Period of inclusion not stated |
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Participants |
Inclusion criteria
Exclusion criteria
Baseline data: randomised to Tigason 0.14 to 0.38 mg/kg/d (n = 11) or placebo (n = 14)
Withdrawal: 4 participants (in the placebo group) were lost because of adverse events (marked hair loss) but not specified if they were included in the analysis |
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Interventions |
Intervention A: oral Tigason 0.14 to 0.38 mg/kg/d (11 participants) Control intervention B: placebo (14 participants) Co‐interventions: none Duration of treatment: 6 months |
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Outcomes | No primary or secondary outcomes pre‐specified | |
Notes | Funding: not reported | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Quote: "Patients were randomised to either Tigason or placebo for 6 months" Comment: insufficient information about the sequence generation process to permit judgement |
Allocation concealment (selection bias) | Unclear risk | Comment: no information on method to guarantee allocation concealment |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Quote: "double‐blind placebo‐controlled" Comment: likely that blinding could have been broken because of Tigason'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 placebo‐controlled" 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: "In the placebo group, there were initially 14 patients but 4 of them were dropouts (side effects = marked hair loss)" Comment: all dropouts were in the placebo group, and not clearly mentioned if they were included in the analysis |
Selective reporting (reporting bias) | Unclear risk | Comment: no protocol found to guarantee that all planned outcomes are presented in the results |