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. 2017 Mar 31;2017(3):CD011639. doi: 10.1002/14651858.CD011639.pub2

Porayko 1994.

Methods  
Participants Country: USA
Number randomised: 37
Postrandomisation dropouts: 0 (0%)
Revised sample size: 37
Average age: 49 years
Females: 14 (37.8%)
Primary transplantation: 37 (100%)
Retransplantation: 0 (0%)
HCV: not stated
HBV: not stated
Alcoholic cirrhosis: 6 (16.2%)
Other causes: 29 (78.4%)
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: no
Other causes: yes
Important exclusion criteria:

  • Poor renal function before transplantation

  • Had hepatocellular carcinoma
Interventions Participants were randomly assigned to 2 groups.
 Group 1: cyclosporine A plus azathioprine plus glucocorticosteroids (n = 17).
 Further details: cyclosporine: attain 100 to 200 ng/mL; azathioprine: 2 mg/kg/day; glucocorticosteroids: prednisolone 10 mg/day.
 Group 2: tacrolimus plus glucocorticosteroids (n = 20).
 Further details: tacrolimus: attain 0.2 to 5 ng/mL; glucocorticosteroids: prednisolone 5 mg/day.
Outcomes The outcomes reported were:

  • mortality,

  • adverse events,

  • renal impairment,

  • retransplantation,

  • graft rejection.
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) Low risk Comment: no published protocol was available; mortality/graft loss and adverse events were reported.
For‐profit bias High risk Quote: "this study was supported by a grant from Fujisawa Pharmaceutical Company, Deerfield, Illinois."
Other bias Low risk Comment: no other bias noted.