Chen 2007.
| Methods | Trial design: randomised, single‐centre clinical trial Mean follow‐up: not reported Intervention A: not reported Intervention B: not reported Study duration: not reported Language: English Type of information: journal article Judgement on quality: unclear risk of bias |
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| Participants | Setting: Tongji Hospital, Wuha, Hubei Province, China Allocation of participants: 54 participants, 28 allocated to Intervention A, 26 allocated to Intervention B Sex ratio: total: 53 (98%) males, 1 (2%) female Intervention A: 27 (96%) males, 1 (4%) female Intervention B: 26 (100%) males, 0 (0%) female Mean age: total: not reported Intervention A: 45.7 ± 3.5 Intervention B: 47.4 ± 6.3 Indication (no. (%)): Hepatocellular carcinoma: total: 54 (100%), Intervention A: 28 (100%), Intervention B: 26 (100%) Type of donor: not reported Inclusion criteria: not reported Exclusion criteria: not reported Other: Cold ischaemia time (minutes): total: not reported, Intervention A: 486.1 ± 97.0, Intervention B: 462.1 ± 88.0 Warm ischaemia time (minutes): total: not reported. Intervention A: 51.5 ± 3.4, Intervention B: 50.8 ± 3.1 |
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| Interventions | Intervention A: glucocorticosteroids: 3 months rapid taper to stop at 3 months, type of glucocorticosteroid and doses not reported Intervention B: glucocorticosteroids: 3 months slow taper with 10 mg/day maintenance long‐term, type of glucocorticosteroid and doses during taper not reported Concomitant immunosuppression: Methylprednisolone: 500 mg/day for 3 days Tacrolimus: aiming for trough doses of 6 to 8 micrograms/mL for 1 year and then 4 to 6 micrograms/mL thereafter Mycophenolate mofetil: 0.5 to 1 g/day for 1 year and then stopped at 1 year |
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| Outcomes | Mortality, acute rejection, creatinine, HCC recurrence, ALT, cholesterol, fasting blood sugar | |
| 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: "Fifty‐four patients suffering from advanced‐stage hepatoma (all exceeding the Milan criterion) underwent liver transplantation between April 2003 and June 2005. There were two immunosuppressive protocols: 28 patients (group A) were given an early steroid‐withdrawal protocol and 26 patients (group B) were given a steroid‐maintenance protocol." Quote from the publication: "This randomized clinical study was focused on a particular group of recipients who suffered from advanced‐stage hepatocellular carcinoma before liver transplantation." Quote from the "Comments" section of the publication: "The present study was a randomized clinical trial of steroid withdrawal after liver transplantation in patients with advanced‐stage hepatocellular carcinoma. We have cited several articles from other investigators that report research on steroid withdrawal after liver transplantation." 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? | Unclear risk | Comment: Study does not appear to be stopped early |
| Free of baseline imbalance? | Low risk | Quote from the publication: "Factors such as age at transplantation, stage of carcinoma, Child‐Pugh score, graft cold ischemic time, anhepatic phase, operation time, and mean level of liver function before operation were noted, and these parameters were well matched in both groups (Table 1)." Comment: Study appears to be free from baseline imbalance |