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

Liberopoulos 2010.

Methods Randomised clinical trial.
Participants Country: Greece.
Number randomised: 10.
Post‐randomisation dropouts: not stated.
Revised sample size: 10.
Mean age: 57 years.
Females: 8 (80%).
Symptomatic participants: not stated.
AMA positive: not stated.
Responders: 0 (0%).
Mean follow‐up period (for all groups): not stated.
Inclusion criteria

  • Symptom status: not stated.

  • AMA status: not stated.

  • Response status: non‐responders only.


Exclusion criteria

  • Cardiovascular disease.

  • Diabetes mellitus.

  • Cancer.

  • Renal disease.

  • Hypothyroidism.

  • Recent lipid‐lowering agent use.

  • Agents that affect lipid metabolism.
Interventions Participants were randomly assigned to 2 groups.
Group 1: UDCA (low) + fenofibrate (n = 6).
Further details: UDCA: 600 mg/day for 8 weeks + fenofibrate: 200 mg/day for 8 weeks.
Group 2: UDCA (low) (n = 4).
Further details: UDCA: 600 mg/day for 8 weeks.
Outcomes None of the outcomes of interest reported.
Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Comment: information not available.
Allocation concealment (selection bias) Unclear risk Comment: information not available.
Blinding of participants and personnel (performance bias) 
 All outcomes High risk Quote: "Continue open‐label UDCA".
Blinding of outcome assessment (detection bias) 
 All outcomes High risk Quote: "Continue open‐label UDCA".
Incomplete outcome data (attrition bias) 
 All outcomes Unclear risk Comment: information not available.
Selective reporting (reporting bias) High risk Comment: neither mortality nor adverse events reported.
For‐profit bias Unclear risk Quote: "This study was conducted independently; no company or institution supported it financially. Some of the authors have given talks, attended conferences and participated in trials and advisory boards sponsored by various pharmaceutical companies".
 Comment: unclear whether the authors were in the advisory board of related pharmaceutical companies.
Other bias Low risk Comment: no other source of bias.