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. 2012 Dec 12;2012(12):CD000551. doi: 10.1002/14651858.CD000551.pub3

Goddard 1994.

Methods Double‐blind, placebo controlled randomised clinical trial with parallel group design (three interventions groups and one control group).
Mean follow‐up: 15 months (range: 0 to 30 months).
Participants Country: UK. 
 Number of patients randomised: 57, mean age and sex ratio not provided. 
 Inclusion criteria:patients with PBC. 
 Exclusion criteria: none listed.
Diagnostic criteria (data being sought).
Interventions Patients were randomly assigned to receive:
Intervention group 1: ursodeoxycholic acid 10mg/kg/day. 
 Intervention group 2: colchicine 1 mg/day.
Intervention group 3: ursodeoxycholic acid plus colchicine.
Control: placebo.
Outcomes Mortality (being sought). 
 Liver transplantation (being sought). 
 Liver biochemistry.
Notes No exact data on number of patients randomised to each arm. Data on mortality and liver transplantation are not given separately.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk The trial is described as randomised, but the method of sequence generation was not specified.
Allocation concealment (selection bias) Unclear risk The trial was described as randomised but the method used to conceal the allocation was not described, so that intervention allocations may have been foreseen in advance of, or during, enrolment.
Blinding (performance bias and detection bias) 
 All outcomes Unclear risk 'Placebo' employed, but it is not known if it was indeed double blind.
Incomplete outcome data (attrition bias) 
 All outcomes Unclear risk Treatment failures were reported but the exact numbers and reasons for dropouts and withdrawals were not described in all intervention groups.
Selective reporting (reporting bias) Unclear risk One or more clinically relevant and reasonably expected outcomes were not reported fully, or it is unclear whether data on these outcomes were recorded or not.
Other bias Unclear risk The trial may or may not be free of information that could put it at risk of bias.