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
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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. |
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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. |