Wiesner 1990.
Methods | Generation of the allocation sequence: unclear. Allocation concealment: unclear. Blinding: patients and investigators were planned to be 'blinded'. However, the assessment of the 'blinding' effectiveness revealed that a considerable unblinding did occur, so we considered it inadequate. Follow‐up: 6 in cyclosporin A group and 3 in placebo group were lost to follow‐up ‐ we considered it adequate. |
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Participants | Country: US. Mean age: 45.5 years in cyclosporin A group, 48.0 years in placebo group. Female/Male: 29/0 PBC stage status: stage I/II: 11 in cyclosporin A group, 5 in placebo group; stage III/IV: 8 in cyclosporin A group, 5 in placebo group. | |
Interventions | Cyclosporin A: 4 mg/kg/day (n = 19); Placebo (n = 10). Median follow‐up: 2.7 years. | |
Outcomes | (1) Mortality and liver transplantation. (2) Clinical outcomes and liver biochemical variables. (3) Histological assessment. (4) Adverse events. | |
Notes | (1) This trial only included precirrhotic patients with primary biliary cirrhosis. (2) It was a preliminary report of first 29 patients out of 59. (3) Correspondence sent to the author on 8 June 2005. No reply was received. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Allocation concealment? | Unclear risk | B ‐ Unclear |