| Methods |
Randomised clinical trial |
| Participants |
Country: USA
Number randomised: 350
Postrandomisation dropouts: 0 (0%)
Revised sample size: 350
Average age: 52 years
Females: 148 (42.3%)
Primary transplantation: 350 (100%)
Retransplantation: 0 (0%)
HCV: 95 (27.1%)
HBV: 15 (4.3%)
Alcoholic cirrhosis: 70 (20%)
Other causes: 160 (45.7%)
Average follow‐up period in months (for all groups): 34
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: tacrolimus plus mycophenolate plus glucocorticosteroids (n = 175).
Further details: tacrolimus: attain 10 to 15 ng/mL; mycophenolate mofetil: 1 g twice daily; glucocorticosteroids: methyl prednisolone 20 mg/day.
Group 2: tacrolimus plus glucocorticosteroids (n = 175).
Further details: tacrolimus: attain 10 to 15 ng/mL; glucocorticosteroids: methyl prednisolone 20 mg/day. |
| Outcomes |
The outcomes reported were:
mortality, graft loss, renal impairment, retransplantation, graft rejection.
|
| Notes |
|
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Low risk |
Quote: "randomization was based on a sequential draw of assignments using a variable block randomization procedure" |
| Allocation concealment (selection bias) |
Low risk |
Quote: "the statisticians gave sealed envelopes to clinicians." |
| 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 |
Unclear risk |
Quote: "supported in part by research grants from the Veterans Administration and project grant no. DK‐29961 from The National Institutes of Health, Bethesda, MD"
Comment: it is not clear if additional funding was received from drug manufacturers. |
| Other bias |
Low risk |
Comment: no other bias noted. |
