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

Nakai 2000.

Methods Randomised clinical trial.
Participants Country: Japan.
Number randomised: 23.
Post‐randomisation dropouts: not stated.
Revised sample size: 23.
Mean age: 57 years.
Females: not stated.
Symptomatic participants: not stated.
AMA positive: not stated.
Responders: not stated.
Mean follow‐up period (for all groups): all participants followed up for 12 months.
Inclusion criteria
  • Symptom status: not stated.

  • AMA status: not stated.

  • Response status: not stated.

Interventions Participants were randomly assigned to 2 groups.
Group 1: UDCA (low) + bezafibrate (n = 13).
Further details: UDCA: 600 mg/day; duration: not stated + bezafibrate: 400 mg/day; duration: not stated.
Group 2: UDCA (low) (n = 10).
Further details: UDCA: 600 mg/day; duration: not stated.
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 Unclear risk Comment: information not available.
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk Comment: information not available.
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 Low risk Quote: "This work was supported by a Grant‐in‐Aid for Scientific Research from the Ministry of Education, Science and Culture of Japan".
Other bias Low risk Comment: no other source of bias.