| Methods |
Randomised clinical trial |
| Participants |
Country: UK
Number randomised: 66
Postrandomisation dropouts: 0 (0%)
Revised sample size: 66
Average age: 48 years
Females: 27 (40.9%)
Primary transplantation: 66 (100%)
Retransplantation: 0 (0%)
HCV: not stated
HBV: not stated
Alcoholic cirrhosis: not stated
Other causes: not stated
Average follow‐up period in months (for all groups): 97
Additional treatment such as antiviral drugs: none stated
Important inclusion and exclusion criteria
Primary transplantation only: yes
Retransplantation only: no
HCV only: not stated
HBV only: not stated
Alcoholic cirrhosis only: not stated
Other causes: not stated |
| Interventions |
Participants were randomly assigned to 2 groups.
Group 1: cyclosporine A (n = 36).
Further details: cyclosporine A: attain 100 to 300 ng/mL.
Group 2: tacrolimus (n = 30).
Further details: tacrolimus: attain 5 to 15 ng/mL. |
| Outcomes |
The outcomes reported were:
mortality, graft loss, retransplantation, graft rejection.
|
| Notes |
|
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Low risk |
Quote: "randomization was by using sealed opaque envelopes consecutively numbered and opened, containing the allocated treatment code, derived from a random numbers table". |
| Allocation concealment (selection bias) |
Low risk |
Quote: "randomization was by using sealed opaque envelopes consecutively numbered and opened, containing the allocated treatment code, derived from a random numbers table". |
| 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 post‐randomisation drop‐outs. |
| Selective reporting (reporting bias) |
High risk |
Comment: no published protocol available; either mortality/graft loss or adverse events or both were not reported. |
| For‐profit bias |
Unclear risk |
Comment: this information was not available. |
| Other bias |
Low risk |
Comment: no other bias noted. |
