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

Meffert 1997.

Study characteristics
Methods RCT, placebo‐controlled, double‐blind
Date of study: not stated
Location: 17 centres in Germany
Participants Randomised: 128 participants
Inclusion criteria
  • Participants with moderate‐severe psoriasis (PASI 8 to 25)

  • Age 18 ‐ 70 years


Exclusion criteria
  • Pregnancy, leucopenia, kidney insufficiency, liver insufficiency

  • Had uncontrolled hypertension


Dropouts and withdrawals
  • 15/128 (12%)

  • Protocol violation (6)

  • Lack efficacy (4)

  • AE (5)

Interventions Intervention
A. Ciclosporin (n = 43), orally, 1.25 mg/kg/d, 10 weeks
Control intervention
B. Ciclosporin (n = 41), orally, 2.5 mg/kg/d, 10 weeks
C. Placebo (n = 44), orally, 10 weeks
Outcomes Assessments at 10 weeks
Primary outcomes of the trial
  • PASI


Secondary outcomes of the trial
  • PASI 25

  • PASI 50

  • PASi 75

Notes Funding source not stated but 3 out of 4 authors from Sandoz pharmaceuticals
Declarations of interest: not stated
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Quote (p 77): "patients were randomised"
Comment: no description of the method used to guarantee random sequence generation
Allocation concealment (selection bias) Unclear risk Comment: no description of the method used to guarantee allocation concealment
Blinding of participants and personnel (performance bias)
All outcomes Unclear risk Quote (p 77): "double blind study period"
Comment: no description of the method used to guarantee blinding regarding the need of hypertension and renal function surveillance and modification in ciclosporin groups
Blinding of outcome assessment (detection bias)
All outcomes Unclear risk Quote (p 77): "double blind study period"
Comment: no description of the method used to guarantee blinding, regarding the need of hypertension and renal function surveillance and modification in ciclosporin groups
Incomplete outcome data (attrition bias)
All outcomes Unclear risk 128 included/120 analysed
Comment: methods for dealing with missing data not specified, not ITT analyses
Selective reporting (reporting bias) Unclear risk Comment: no protocol was available. The prespecified outcomes mentioned in the Methods section appeared to have been reported