| Methods |
Randomised clinical trial |
| Participants |
Country: USA
Number randomised: 99
Postrandomisation dropouts: 0 (0%)
Revised sample size: 99
Average age: 48 years
Females: 39 (39.4%)
Primary transplantation: 99 (100%)
Retransplantation: 0 (0%)
HCV: 37 (37.4%)
HBV: 7 (7.1%)
Alcoholic cirrhosis: 11 (11.1%)
Other causes: 44 (44.4%)
Average follow‐up period in months (for all groups): 48
Additional treatment such as antiviral drugs: none stated
Important inclusion and exclusion criteria
Primary transplantation only: yes
Retransplantation only: no
HCV only: no
HBV only: no
Alcoholic cirrhosis only: no
Other causes: yes |
| Interventions |
Participants were randomly assigned to 2 groups.
Group 1: cyclosporine A plus mycophenolate (n = 50).
Further details: cyclosporine A: attain 200 to 300 ng/mL; mycophenolate mofetil: 1 g/day.
Group 2: tacrolimus plus mycophenolate (n = 49).
Further details: tacrolimus: attain 5 to 10 ng/mL; mycophenolate mofetil: 1 g/day. |
| Outcomes |
|
| Notes |
|
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Unclear risk |
Comment: this information was not available. |
| Allocation concealment (selection bias) |
Unclear risk |
Comment: this information was not available. |
| Blinding of participants and personnel (performance bias)
All outcomes |
High risk |
Quote: "open‐label" |
| Blinding of outcome assessment (detection bias)
All outcomes |
High risk |
Quote: "open‐label" |
| Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
Comment: there were no postrandomisation dropouts. |
| Selective reporting (reporting bias) |
High risk |
Comment: no published protocol was available; either mortality/graft loss or adverse events, or both were not reported. |
| For‐profit bias |
High risk |
Quote: "this study was supported in part by a grant from Hoffman, LaRoche Inc." |
| Other bias |
Low risk |
Comment: no other bias noted. |
