Saurat 1988.
Study characteristics | ||
Methods | RCT, active/placebo‐controlled, double‐blind Date of study: not stated Location: 6 centres in France and Switzerland |
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Participants |
Randomised: 42 participants (placebo (22) mean age 43 years, 16 male; acitretin (20), mean age 46 years, 16 male) Inclusion criteria
Exclusion criteria
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/weeks, daily, 10 weeks Control intervention C. 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 of the trial
Outcomes of the trial
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Notes | Funding: 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: not 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 |