| Methods |
Randomised clinical trial |
| Participants |
Country: France
Number randomised: 174
Postrandomisation dropouts: 0 (0%)
Revised sample size: 174
Average age: 52 years
Females: 50 (28.7%)
Primary transplantation: 174 (100%)
Retransplantation: 0 (0%)
HCV: 26 (14.9%)
HBV: 12 (6.9%)
Alcoholic cirrhosis: 84 (48.3%)
Other causes: 52 (29.9%)
Average follow‐up period in months (for all groups): 6
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: cyclosporine A plus glucocorticosteroids (n = 90).
Further details: cyclosporine A: attain 150 to 300 ng/mL; glucocorticosteroids: prednisolone 20 mg/day.
Group 2: cyclosporine A (n = 84).
Further details: cyclosporine A: attain 150 to 300 ng/mL. |
| Outcomes |
The outcomes reported were:
mortality, adverse events, 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 |
Low risk |
Quote: "double‐blind, placebo‐controlled study" |
| Blinding of outcome assessment (detection bias)
All outcomes |
Low risk |
Quote: "double‐blind, placebo‐controlled study" |
| 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: "supported by a grant from Novartis Pharma" |
| Other bias |
High risk |
Comment: despite following participants for 12 months, the authors present only the 6‐month results and have excluded 2 late deaths. |
