Saurat 1988.
| Study characteristics | ||
| Methods | RCT, active/placebo‐controlled, double‐blind study Date of study: not stated Location: 6 centres in France and Switzerland |
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| Participants |
Randomised: 42 participants Inclusion criteria
Exclusion criteria
Baseline characteristics N = 42, mean age of 44.5 years, 32 male Dropouts and withdrawals
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| Interventions |
Intervention A. Acitretin (n = 20), orally, 2 x 25/d 2 weeks and 25/d + UVA 3/week, daily, 10 weeks Control intervention B. Placebo, orally (n = 22), daily, 10 weeks Co‐intervention: UVA 3/week, 10 weeks |
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| Outcomes | Assessments not clearly stated (reported at 8 weeks) Primary outcomes
Outcomes
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| Notes |
Funding source: not stated Declarations of interest: not stated |
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| 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: no 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. |