Bobadilla 1994.
Methods | Randomised clinical trial. | |
Participants | Country: Mexico. Number randomised: 40. Post‐randomisation dropouts: not stated. Revised sample size: 40. Mean age: not stated. 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 (moderate) + colchicine (n = 21). Further details: UDCA: 13 mg/kg/day to 15 mg/kg/day for 1 year + colchicine: 1 mg/day for 5 days in a week for 1 year. Group 2: placebo (n = 19). |
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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: although placebo used in double‐blind trial, unclear whether the placebo was identical. |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Comment: although placebo used in double‐blind trial, unclear whether the placebo was identical. |
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 | Comment: information not available. |
Other bias | Low risk | Comment: no other source of bias. |