Hosonuma 2015.
Methods | Randomised clinical trial. | |
Participants | Country: Japan. Number randomised: 27. Post‐randomisation dropouts: 0 (0%). Revised sample size: 27. Mean age: 64 years. Females: 22 (81.5%). Symptomatic participants: not stated. AMA positive: not stated. Responders: 0 (0%). Mean follow‐up period (for all groups): minimum: 96 months. Inclusion criteria
Other inclusion criteria
Exclusion criteria
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Interventions | Participants were randomly assigned to 2 groups. Group 1: UDCA (moderate) + bezafibrate (n = 13). Further details: UDCA: 12 mg/kg/day to 15 mg/kg/day; duration: not stated + bezafibrate: 400 mg/day; duration: not stated. Group 2: UDCA (moderate) (n = 14). Further details: UDCA: 12 mg/kg/day to 15 mg/kg/day; duration: not stated. |
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Outcomes | Mortality, adverse events, liver transplantation. | |
Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "Sealed opaque envelopes" (author's reply). |
Allocation concealment (selection bias) | Low risk | Quote: "These patients were randomly allocated to treatment with either UDCA alone (the UDCA group) or with the combination therapy (the UDCA+BF [bezafibrate] group), according to sequential sealed envelopes in blocks of four to ensure equal randomization for the duration of the study". |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Quote: "However, our study was an unblinded, open trial and was therefore not free from bias". |
Blinding of outcome assessment (detection bias) All outcomes | High risk | Quote: "However, our study was an unblinded, open trial and was therefore not free from bias". |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Comment: no post‐randomisation dropouts. |
Selective reporting (reporting bias) | Low risk | Comment: mortality and adverse events reported. |
For‐profit bias | Low risk | Quote: "This study was supported by the authors' own research funds". |
Other bias | Low risk | Comment: no other source of bias. |