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. 2017 Mar 28;2017(3):CD011648. doi: 10.1002/14651858.CD011648.pub2

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
  • Symptom status: not stated.

  • AMA status: not stated.

  • Response status: non‐responders only.


Other inclusion criteria
  • People with dyslipidaemia.


Exclusion criteria
  • Other liver diseases, e.g. alcoholic liver disease.

  • Obstructive biliary disease.

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.
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.