Lombard 1993.
Methods | Generation of the allocation sequence: a schedule of block randomisation ‐ considered adequate. Allocation concealment: a 'blinded' investigator ‐ considered adequate. Blinding: patients and investigators ‐ considered adequate. Follow‐up: 40 in cyclosporin A group and 25 in placebo group were lost to follow‐up ‐ considered adequate. |
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Participants | Country: UK. Mean age: 53.9 years in cyclosporin A group, 54.2 years in placebo group. Female/Male: 298/51. PBC stage status: stage I/II: 62 in cyclosporin A group, 71 in placebo group; stage III/IV: 87 in cyclosporin A group, 71 in placebo group. | |
Interventions | Cyclosporin A: 3 mg/kg/day (n = 176); Placebo (n = 173). Median follow‐up: 928 days (range 6 to 2146 days). | |
Outcomes | (1) Mortality and liver transplantation. (2) Clinical outcomes and liver biochemical variables. (3) Adverse events. | |
Notes | (1) Two types of analysis were presented: the first one was on death (the end point) and liver transplantation censored at time of transplantation; the second one combined death and liver transplantation. (2) Correspondence sent to the author on 8 June 2005. No reply was received. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Allocation concealment? | Low risk | A ‐ Adequate |