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

Benitez 2010.

Methods Randomised clinical trial
Participants Country: Spain
 Period of recruitment: 2006‐2008
 Number randomised: 37
 Post‐randomisation dropouts: 0 (0.0%)
 Revised sample size: 37
 Average age (years): 52
 Females: 7 (18.9%)
 Primary transplantation: 37 (100.0%)
 Reason for transplantation
 Alcohol‐related cirrhosis: 25 (67.6%)
 Viral‐related cirrhosis: 2 (5.4%)
 Autoimmune disease‐related cirrhosis: 0 (0%)
HCC: 9 (24.3%)
Others: 11 (29.7%)
Maintenance immunosuppression used during induction immunosuppression: tacrolimus
Altered immunosuppression after withdrawal: no
Other exclusion criteria:
  • autoimmune liver disease

  • HCV and/or HIV infection

  • liver transplantation with partial graft

  • previous use of rabbit immunoglobulins

  • acute liver failure

Interventions Group 1: anti‐thymocyte globulin + glucocorticosteroids (n = 21)
 Further details: anti‐thymoglobulin 9 mg/kg was started 2–3 h before transplantation and infused i.v. over a 6‐h period preceded by 500 mg methylprednisolone i.v.
 Group 2: glucocorticosteroids (n = 16)
 Further details: corticosteroids were administered as follows: 1 g methylprednisolone i.v. during the surgical procedure, 20 mg prednisone daily during the first post‐transplant month, and thereafter doses were tapered down until complete discontinuation during post‐transplant months 3– 6
Outcomes Outcomes reported: mortality at maximal follow‐up, graft failure at maximal follow‐up, serious adverse events (number of events), graft rejection (any)
 Follow‐up (months): 12
Notes Source of funding (quote): "This work was supported by grants from Fresenius Biotech GmbH, Astellas and by the Ministerio de Educaci on y Ciencia, Spain"
 Trial name/trial registry number: NCT00436722
 Attempts were made to contact the authors in August 2019.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: "The randomization sequence was computed‐generated and kept in opaque sealed envelopes."
Allocation concealment (selection bias) Low risk Quote: "The randomization sequence was computed‐generated and kept in opaque sealed envelopes."
Blinding of participants and personnel (performance bias) 
 All outcomes High risk Quote: "prospective, randomized, open label, controlled trial"
Blinding of outcome assessment (detection bias) 
 All outcomes High risk Quote: "prospective, randomized, open label, controlled trial"
Incomplete outcome data (attrition bias) 
 All outcomes Low risk Comment: there were no post‐randomisation dropouts
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 dose of tacrolimus was different in the two groups