Schroder 1989.
Methods | Randomised, parallel‐arm trial Three centres in Germany (community centre clinics) Period of inclusion: March 1986 to February 1988 |
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Participants |
Inclusion criteria
Exclusion criteria
Baseline data: participants were randomised to receive etretinate (n = 15) or placebo (n = 15)
Withdrawal: not stated |
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Interventions |
Intervention 1 A: etretinate 50 mg once per day (15 participants) Intervention 2 B: placebo (15 participants) Co‐interventions: 2% salicylic ointment Duration of treatment: 4 weeks |
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Outcomes | No primary or secondary outcome pre‐specified
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Notes | Funding: not reported | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Quote: "The patients were admitted using a list of randomisation" Comment: no precision on how it was generated |
Allocation concealment (selection bias) | Unclear risk | Quote: "either etretin or placebo" Comment: no information on method to guarantee allocation concealment |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Quote: "double‐blind study" Comment: however, 65% of participants treated with Tigason had side effects (mainly mucocutaneous side effects), so likely that blinding could have been broken |
Blinding of outcome assessment (detection bias) All outcomes | High risk | Quote: "double‐blind study" Comment: however, 65% of participants treated with Tigason had side effects (mainly mucocutaneous side effects), so likely that blinding could have been broken |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Comment: no mention of missing data |
Selective reporting (reporting bias) | High risk | Comment: no protocol found to guarantee that all planned outcomes are presented in the results. Not all outcomes cited in the methods were found in the results (clinical aspect: 4‐point‐score) |