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
Exclusion criteria
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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). |
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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. |