Hu 2008.
| Methods | Trial design: randomised, single‐centre clinical trial Mean follow‐up: not reported Study duration: 6 months from randomisation, randomisation from September 2006 to March 2008 Language: Mandarin Type of information: journal article Judgement on quality: unclear risk of bias |
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| Participants | Setting: Organ Transplantation Center, the First Affiliated Hospital of Sun Yat‐Sen University, Guangzhou, China Allocation of participants: 76 participants, 36 allocated to Intervention A, 40 allocated to Intervention B Sex ratio: total: not reported Intervention A: 5:1 (numbers and % not reported) Intervention B: 4:1 (numbers and % not reported) Mean age: total: not reported Intervention A: 47.6+/‐5.8 Intervention B: 45.2+/‐6.5 Indication (no. (%)): not reported Type of donor: deceased donor Inclusion criteria: first liver transplantation, hepatocellular carcinoma, aged 18 to 65, deceased donor transplantation and informed consent given Exclusion criteria: previous liver transplant, multi‐organ transplantation, living donor transplantation, ABO‐incompatible transplantation. Primary disease: primary sclerosing cholangitis or autoimmune hepatitis. Preoperative psychiatric symptoms, gastric ulcer, use of hormones, diabetes mellitus, hypertension, hyperlipidaemia or malignancy other than primary hepatocellular carcinoma. Participation in other trials |
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| Interventions | Intervention A: no intervention Intervention B: prednisone from day 8, commencing at 48 mg reduced by 8 mg every 3 days to a maintenance dose of 4 mg by day 26, stopped after 3 months Concomitant immunosuppression: Tacrolimus: 3 mg intraoperatively then adjusted postoperatively to 8 to 12 micrograms/mL Methylprednisolone: 1000 mg intraoperatively, then 500 mg on day 1, 240 mg on day 2, 200 mg on day 3, 160 mg on day 4, 80 mg on day 5, 40 mg on day 6 and 20 mg on day 7 |
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| Outcomes | Mortality, infection, hepatic artery thrombosis, hypertension, diabetes mellitus, hyperlipidaemia, neurotoxicity, gastrointestinal complications, other adverse events | |
| Notes | Cross‐over between intervention arms: no Sample size calculation: not reported Sources of funding: National Nature foundation, China Medical Board in New York, Nature foundation of Guangzhou province |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | 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 outcomes appear to be fully 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: Study appears to be free from baseline imbalance |