Methods | RCT, active‐controlled, open‐label trial Date of study: not stated Location: not stated |
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Participants |
Randomised: 22 participants (mean age 45.9 years, 18 male) Inclusion criteria
Exclusion criteria
Dropouts and withdrawals
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Interventions |
Intervention A. Ciclosporin A (n = 10), orally, 1.25 mg/kg/d (increase to 2.5 if PASI > 50% of initial PASI), 12 months Control intervention B. Ciclosporin A, (n = 12), orally, 2.5 mg/kg/d (increase to 5 if PASI > 50% of initial PASI), 12 months |
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Outcomes | Assessment period: not stated but longer than 16 weeks Primary or secondary outcomes of the trial: not stated 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 189): "Patients enrolled in the study were randomised..." Comment: no description of the method used to guarantee random sequence generation |
Allocation concealment (selection bias) | Unclear risk | Quote (p 189): "Patients enrolled in the study were randomised..." Comment: no description of the method used to guarantee allocation concealment |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Comment: not blinded (open‐label) |
Blinding of outcome assessment (detection bias) All outcomes | High risk | Comment: not blinded (open‐label) |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk |
Dropouts and withdrawals
Management of missing data: no description of the method used to guarantee management of missing data, ITT analyses not mentioned |
Selective reporting (reporting bias) | High risk | Comment: no protocol was available. The pre‐specified outcomes mentioned in the methods section were not reported in results section |