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. 2021 Apr 19;2021(4):CD011535. doi: 10.1002/14651858.CD011535.pub4

Sandhu 2003.

Study characteristics
Methods RCT, active‐controlled, open‐label
Date of study: not stated
Location: multicentric (number not stated) in North India
Participants Randomised: 30 participants (methotrexate: mean age 39 years, 12 male; ciclosporin: mean age 46 years, 13 male)
Inclusion criteria
  • Participants with moderate‐severe psoriasis (BSA > 40%), age ≥ 18 years


Exclusion criteria
  • Pregnancy, kidney insufficiency, liver insufficiency

  • Had uncontrolled hypertension

  • Had past history of malignant tumours


Dropouts and withdrawals
  • Not stated

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
Outcomes Assessments at 12 weeks
Primary or secondary outcomes of the trial
  • Not clearly defined


Outcomes of the trial
  • PASI

Notes Funding source: not stated
Declarations of interest: not stated
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