Ju 2012.
| Methods | Trial design: randomised, single‐centre clinical trial Mean follow‐up: total: not reported; Intervention A: 23 months (range: 12 to 36 months); Intervention B: 21 months (range: 12 to 36 months) Study duration: 3 years from randomisation, randomisation from September 2006 to September 2008 Language: English 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: 87 participants, 44 allocated to Intervention A, 43 allocated to Intervention B Sex ratio: total: 64 (78.0%) males, 18 (22.0%) females Intervention A: not reported Intervention B: not reported Mean age: total: 45.7 (range: 26 to 68) Intervention A: not reported Intervention B: not reported Indication (no. (%)): (indications reported for whole study population but not intervention groups) Hepatocellular carcinoma: total: 36 (43.9%) HBV cirrhosis: total: 33 (40.2%) HCV cirrhosis: total: 3 (3.7%) Alcoholic cirrhosis: total: 3 (3.7%) Severe hepatitis: total: 6 (7.3%) Polycystic liver: total: 1 (1.2%) Type of donor: deceased donor Inclusion criteria: adult liver transplant recipients Exclusion criteria: pretransplant infection (except HBV, HCV), marginal grafts (donors with moderate to severe NAFLD, HBV infection, age > 60, cold ischaemia > 14 hours), multiorgan transplants, retransplant, partial liver transplant including living donor, lack of consent, ABO incompatibility |
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| Interventions | Intervention A: no intervention Intervention B: methylprednisolone at 240 mg on day 1 tapered by 10 mg/day for 8 days. Prednisone at 48 mg on day 9 with 8 mg tapered until 4 mg/day by day 26 before stopping at 3 months Concomitant immunosuppression: Methylprednisolone: 500 mg intraoperatively Basiliximab: 20 mg perioperatively Tacrolimus: commenced on day 4 at 0.04 mg/kg/day aiming for trough levels of 8 to 12 ng/mL, tapered to 6 to 10 ng/mL by 3 months and 5 to 8 ng/mL by 6 months Mycophenolate mofetil: as required Sirolimus: as required |
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| Outcomes | Mortality, acute rejection, CMV infection, hypertension, hyperlipidaemia, hyperglycaemia, infection | |
| Notes | Cross‐over between intervention arms: no Sample size calculation: not reported Sources of funding: National High Technology Research and Development Program of China, the Key Clinical Project from the Ministry of Health, National Natural Science Foundation of China, special fund for science research by Ministry of Health, the China Medical Board in New York, the Key Projects in the National Science & Technology Pillar Program during the Eleventh Five‐Year Plan Period of China and Science and Technology Planning Project of Guangdong Province |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Quote from the publication: "After screening, 91 patients were randomized to receive standard immunosuppressive protocol (SP group) or 24‐hour steroid avoidance protocol (24‐h SA group) according to random sequence generated by SPSS software (SPSS: An IBM Company, version 13.0, IBM Corporation, Armonk, New York, USA)." Comment: Randomisation achieve by computer‐generated random sequence |
| 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 | Quote from the publication: "Nine patients were excluded from the analysis owing to ABO blood type incompatibility (4/9) and perioperative death (5/9). Among the patients who died perioperatively, 3 patients in the SP group died of acute heart failure (1/5), renal failure (1/5), and massive intraperitoneal bleeding (1/5), and 2 patients in the 24‐h SA group died of renal failure (1/5) and primary allograft nonfunction (1/5)." Comment: The publication provides sufficient information to allow participants excluded due to perioperative mortality to be re‐entered into the meta‐analysis. Otherwise, the 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? | Unclear risk | Quote from the publication: "There was no significant difference between the groups when comparing the number of cases and duration of MMF or sirolimus use postoperatively (Table 1)." Comment: The publication reports that there is no significant difference between mycophenolate mofetil or sirolimus use between the groups both other baseline characteristics are not reported |