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. 2020 Jan 16;2020(1):CD013203. doi: 10.1002/14651858.CD013203.pub2

Yoshida 2005.

Methods Randomised clinical trial
Participants Country: Canada
Period of recruitment: not stated
Number randomised: 148
Post‐randomisation dropouts: 0 (0.0%)
Revised sample size: 148
Average age (years): 53
Females: 48 (32.4%)
Primary transplantation: 148 (100.0%)
Reason for transplantation
Alcohol‐related cirrhosis: 29 (19.6%)
Viral‐related cirrhosis: 56 (37.8%)
Autoimmune disease‐related cirrhosis: 34 (23.0%)
HCC: not stated
Others: 29 (19.6%)
Maintenance immunosuppression used during induction immunosuppression: tacrolimus plus mycophenolate mofetil
Altered immunosuppression after withdrawal: no
Other exclusion criteria:
  • living donor liver transplant

  • ABO blood group incompatibility

  • multiple organ transplant

  • serum creatinine > 180 micromol/L or dialysis

  • fulminant liver failure

Interventions Group 1: daclizumab + glucocorticosteroids (n = 72)
 Further details: daclizumab 2 mg/kg i.v. within 4 hours postoperatively and 1 mg/kg i.v. on postoperative day 4 + methylprednisolone 500 mg i.v. intraoperatively, tapering to 20 mg i.v. on postoperative day 5 followed by prednisone 5 mg/day orally. The prednisone was then tapered by 5 mg/month until discontinuation after the month 3 post‐transplant
 Group 2: glucocorticosteroids (n = 76)
 Further details: methylprednisolone 500 mg i.v. intraoperatively, tapering to 20 mg i.v. on postoperative day 5 followed by prednisone 5 mg/day PO. The prednisone was then tapered by 5 mg/month until discontinuation after the month 3 post‐transplant
Outcomes Outcomes reported: mortality at maximal follow‐up, serious adverse events (number of events), liver transplantation at maximal follow‐up, graft rejection (any)
 Follow‐up (months): 12
Notes Source of funding: not stated
 Trial name/trial registry number: not stated
 Attempts were made to contact the authors in August 2019.
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 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 Low risk Comment: there were post‐randomisation dropouts. It was not clear whether these could be related to the interventions
Selective reporting (reporting bias) Low risk Comment: no pre‐published protocol was available, but the authors reported on mortality, graft loss, and adverse events
Other bias High risk Comment: the regimen for tacrolimus was different between the groups

Abbreviations:

HCC: hepatocellular carcinoma

HCV: Hepatitis C virus

OLT: orthotopic liver transplantation

RNA: ribonucleic acid