Skip to main content
. 2017 Mar 28;2017(3):CD011648. doi: 10.1002/14651858.CD011648.pub2

Wiesner 1990.

Methods Randomised clinical trial.
Participants Country: USA.
Number randomised: 40.
Post‐randomisation dropouts: 11 (27.5%).
Revised sample size: 29.
Mean age: 46 years.
Females: 28 (96.6%).
Symptomatic participants: not stated.
AMA positive: not stated.
Responders: not stated.
Median follow‐up period (for all groups): 35 months.
Inclusion criteria
  • Symptom status: not stated.

  • AMA status: not stated.

  • Response status: not stated.


Exclusion criteria
  • Cirrhosis or advanced liver disease.

  • Renal dysfunction.

  • Uncontrolled hypertension.

  • Neoplastic disease.

  • Skin cancer.

  • Previous immunosuppressive therapy.

  • Other liver diseases.

Interventions Participants were randomly assigned to 2 groups.
Group 1: ciclosporin (n = 19).
Further details: ciclosporin: 4 mg/kg/day.
Group 2: placebo (n = 10).
Outcomes Mortality, adverse events, liver transplantation.
Notes Reasons for post‐randomisation dropouts: follow‐up < 1 year.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Comment: information not available.
Allocation concealment (selection bias) Unclear risk Comment: information not available.
Blinding of participants and personnel (performance bias) 
 All outcomes Low risk Comment: identical placebo used in this double‐blind trial.
Blinding of outcome assessment (detection bias) 
 All outcomes Low risk Comment: identical placebo used in this double‐blind trial.
Incomplete outcome data (attrition bias) 
 All outcomes Unclear risk Comment: information not available.
Selective reporting (reporting bias) Low risk Comment: mortality and morbidity reported.
For‐profit bias High risk Quote: "Supported by a grant from Sandoz and by the Mayo foundation".
Other bias Low risk Comment: no other source of bias.