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

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:
  • People with cancer

  • People undergoing multiple organ transplantation

  • People with pre‐existing renal failure

  • Active infection

  • Stage 4 coma, defined as unconscious and ventilator dependent

  • Clinically significant heart or lung disease

  • Previous reconstructive or bypass procedures of the liver

  • Technically unsatisfactory operations with poor immediate liver function

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:
  • mortality,

  • graft loss,

  • adverse events,

  • renal impairment,

  • retransplantation,

  • graft rejection.

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.