Belli 1998.
| Methods | Trial design: randomised, single‐centre clinical trial Mean follow‐up: total: 41 ± 16 months, range 4 to 68 months Study duration: date of randomisation to last follow‐up before 28 February 1997, or patient death or re‐transplantation Language: English Type of information: journal article Judgement on quality: unclear risk of bias |
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| Participants | Setting: Ospedale Niguarda Ca' Granda, Milan, Italy Allocation of participants: 104 participants, 50 allocated to long‐term glucocorticosteroids, 54 allocated to short‐term glucocorticosteroids Sex ratio: total: 74 (71%) males, 30 (29%) females Intervention A: 37 (74%) males, 13 (26%) females Intervention B: 37 (68.5%) males, 17 (31.5%) females Mean age: total: not reported Intervention A: 45 ± 14 Intervention B: 42 ± 16 Indication (no. (%)): (indications reported for whole study population but not intervention groups) HCV: 42 (40.4%) HBV: 24 (23.1%) HBV and HCV: 8 (7.7%) Alcoholic cirrhosis: 9 (8.7%) Primary biliary cirrhosis: 6 (5.8%) Cryptogenic cirrhosis: 8 (7.7%) Others: 7 (6.7%) Type of donor: not reported Inclusion criteria: adult liver transplant recipients Exclusion criteria: previous liver transplant, previous other organ transplant, multiorgan transplant Other: rejection before randomisation (n (%)): Intervention A: 15 (30%) Intervention B: 22 (41%) |
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| Interventions | Intervention A: methylprednisolone: from day 90, 20 mg per day with 5 mg reductions every 2 weeks until stopped Intervention B: methylprednisolone: from day 90, 20 mg per day with 5 mg reductions every 2 weeks until maintenance dose of 0.1 mg/kg/day continued for duration of study Concomitant immunosuppression: Rabbit antithymocyte globulins: 2 mg/kg/day for 5 to 7 days from day 0 Cyclosporine A: 200 to 300 ng/mL (from day 90 for "first months") and 150 ng/mL to 250 ng/mL thereafter Methylprednisolone: 1000 mg intraoperatively; 200 mg at day 1; 160 mg at day 2; 120 mg at day 3; 80 mg at day 4; 40 mg at day 5; 20 mg at day 6; then continued at the same dose until day 90 |
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| Outcomes | Patient survival, acute rejection, chronic rejection, hypertension, diabetes, severe bone complications, infections, serum cholesterol, recurrent hepatitis B, recurrent hepatitis C and treatment failure | |
| Notes | Cross‐over between intervention arms: no Sample size calculation: not reported Sources of funding: not reported |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Quote from the publication: "One hundred four first orthotopic liver transplantations performed between May 1991 and June 1995 at the Niguarda Hospital in Milan and surviving long enough to reach the randomization time point were prospectively assigned to one of the two maintenance immunosuppressive regimens. Fifty patients were randomized to receive cyclosporine plus long‐term corticosteroids (Group I) and 54 patients were randomized to cyclosporine monotherapy (Group II)." Comment: Generation of randomisation sequence not described |
| Allocation concealment (selection bias) | Unclear risk | Comment: Allocation concealment not described |
| Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Comment: Blinding of participants and medical staff not described |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Comment: Blinding of outcome assessors not described |
| Incomplete outcome data (attrition bias) | Unclear risk | Comment: Number of withdrawals and reasons for withdrawal not reported |
| Selective reporting (reporting bias) | Low risk | Comment: All predefined outcomes and clinically relevant outcomes appear to be reported |
| Other bias | Unclear risk | Comment: No sample size calculation reported |
| Free of early stopping? | Low risk | Comment: Study not stopped early |
| Free of baseline imbalance? | Low risk | Comment: No evidence of baseline imbalance reported in "Table 3" |