Lassus 1988.
Methods | Parallel‐arm trial Number of centres not stated Period of inclusion not stated |
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Participants |
Inclusion criteria Not stated Exclusion criteria
Participants were examined before treatment and at weeks 2, 4, 8, and 12 Baseline data: randomised to acitretin (n = 30) or etretinate (n = 30)
Withdrawal: 1 in the acitretin group (complete remission after week 4) and 1 in the etretinate group (failed to return for follow‐up visits) |
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Interventions |
Intervention 1 A: acitretin (3 capsules of 10 mg each, once per day) (30 participants) Intervention 2 B: etretinate (3 capsules of 10 mg each, once per day) (30 participants) Co‐interventions: topical corticosteroids, oral antibiotics Duration of treatment: 12 weeks |
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Outcomes | No primary or secondary outcome pre‐specified ‐ Decrease in the number of fresh pustules ‐ Severity score depending on intensity of erythema, scaling, and infiltration (3 = severe, 2 = moderate, 1 = mild, 0 = none) ‐ Area of involvement ‐ Adverse events |
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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: "patients were randomly allocated to one of the two retinoid treatment groups" Comment: insufficient information about the sequence generation process to permit judgement |
Allocation concealment (selection bias) | Unclear risk | Quote: "patients were randomly allocated to one of the two retinoid treatment groups" Comment: no information on method to guarantee allocation concealment |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Quote: "double‐blind comparative trial" Comment: unlikely that blinding could have been broken because both treatments are retinoids and have identical side effects |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Quote: "double‐blind comparative trial" Comment: unlikely that blinding could have been broken because both treatments are retinoids and have identical side effects |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Quote: "Two patients left the study before 12 weeks of treatment; one from the etretinate group failed to return for follow‐up visits after the week 2 check while the other patient, who belonged to the acitretin group, discontinued treatment because of complete remission after 4 weeks" Comment: 2 participants dropped out but unclear how study authors dealt with it, especially that the dropout in the acitretin group was cleared, whereas we have no precision regarding the dropout in the etretinate group |
Selective reporting (reporting bias) | Unclear risk | Comment: no protocol found to guarantee that all planned outcomes are presented in the results |