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

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
  • Symptom status: not stated.

  • AMA status: not stated.

  • Response status: not stated.

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).
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.