Fung 1991.
Methods | Randomised clinical trial | |
Participants | Country: USA Number randomised: 81 Postrandomisation dropouts: not stated Revised sample size: 81 Average age: 42 years Females: 33 (40.7%) Primary transplantation: 81 (100%) Retransplantation: 0 (0%) HCV: not stated HBV: 0 (0%) Alcoholic cirrhosis: not stated Other causes: not stated Average follow‐up period in months (for all groups): 12 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: no Alcoholic cirrhosis only: not stated Other causes: not stated Important exclusion criteria:
|
|
Interventions | Participants were randomly assigned to 2 groups. Group 1: cyclosporine A (n = 40). Further details: cyclosporine A: attain 600 to 800 ng/mL. Group 2: tacrolimus (n = 41). Further details: tacrolimus: attain 1 to 5 ng/mL. | |
Outcomes | The outcomes reported were:
|
|
Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "treatment assignment was determined by a computer program implementing the block randomization technique, to assure that the treatment groups remained reasonably balanced" |
Allocation concealment (selection bias) | Low risk | Quote: "a sealed envelope method was implemented. Each envelope contained a single treatment assignment". |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Comment: this information was not available. |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Comment: this information was not available. |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Comment: this information was not available. |
Selective reporting (reporting bias) | Low risk | Comment: no published protocol available; mortality/graft loss and adverse events were reported. |
For‐profit bias | Low risk | Quote: "this work was supported by research grant OK 29961 from the National Institutes of Health, Bethesda, Maryland, and the Veterans Administration". |
Other bias | Low risk | Comment: no other bias noted. |