Gao 2012.
Methods | Randomised clinical trial. | |
Participants | Country: China. Number randomised: 79. Post‐randomisation dropouts: not stated. Revised sample size: 79. Mean age: 53 years. Females: 77 (97.5%). Symptomatic participants: not stated. AMA positive: not stated. Responders: not stated. Mean follow‐up period (for all groups): not stated. Inclusion criteria
Other inclusion criteria
Exclusion criteria
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Interventions | Participants were randomly assigned to 3 groups. Group 1: UDCA (moderate) (n = 29). Further details: UDCA: 13 mg/kg/day to 15 mg/kg/day; duration: not stated. Group 2: UDCA (moderate) + glucocorticosteroids (n = 37). Further details: UDCA: 13 mg/kg/day to 15 mg/kg/day; duration: not stated + prednisolone: 7.5 mg/day; duration: not stated. Group 3: UDCA (moderate) + azathioprine (n = 13). Further details: UDCA: 13 mg/kg/day to 15 mg/kg/day; duration: not stated + azathioprine: 1 mg/kg/day; duration: not stated. |
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Outcomes | Adverse events, decompensated liver disease. | |
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: mortality not reported. |
For‐profit bias | Unclear risk | Comment: information not available. |
Other bias | Low risk | Comment: no other source of bias. |