Sandhu 2003.
Study characteristics | ||
Methods | RCT, active‐controlled, open‐label Date of study: not stated Location: multicentric (number not stated) in North India |
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Participants |
Randomised: 30 participants (methotrexate: mean age 39 years, 12 male; ciclosporin: mean age 46 years, 13 male) Inclusion criteria
Exclusion criteria
Dropouts and withdrawals
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Interventions |
Intervention A. Methotrexate (n = 15), orally, 0.5 mg/kg dose tapered after PASI 75 obtained Control intervention B. Ciclosporin (n = 15), orally, 3 mg/kg increased to 4 if no change or rise of dose tapered after PASI 75 obtained |
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Outcomes | Assessments at 12 weeks Primary or secondary outcomes of the trial
Outcomes of the trial
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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 459): "Patients were randomly assigned to either..." Comment: no description of the method used to guarantee random sequence generation |
Allocation concealment (selection bias) | Unclear risk | Quote (p 459): "Patients were randomly assigned to either..." Comment: no description of the method used to guarantee allocation concealment |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Comment: not blind |
Blinding of outcome assessment (detection bias) All outcomes | High risk | Comment: not blind |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | 30 included/30 analysed Methods for dealing with missing data: not stated |
Selective reporting (reporting bias) | Unclear risk | Comment: no protocol was available. The prespecified outcomes mentioned in the Methods section appeared to have been reported.No primary outcome declared |