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

Triger 1980.

Methods Randomised clinical trial.
Participants Country: UK.
Number randomised: 35.
Post‐randomisation dropouts: not stated.
Revised sample size: 35.
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): not stated.
Inclusion criteria
  • Symptom status: not stated.

  • AMA status: not stated.

  • Response status: not stated.

Interventions Participants were randomly assigned to 2 groups.
Group 1: D‐penicillamine (n = not stated).
Further details: D‐penicillamine: 250 mg to 875 mg (escalating dose).
Group 2: placebo (n = not stated).
Outcomes Mortality.
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: in this double‐blind trial, unclear whether the placebo was identical to active treatment.
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk Comment: in this double‐blind trial, unclear whether the placebo was identical to active treatment.
Incomplete outcome data (attrition bias) 
 All outcomes Unclear risk Comment: information not available.
Selective reporting (reporting bias) High risk Comment: adverse events not reported.
For‐profit bias High risk Quote: "The UDCA and placebo tablets were generously donated by Thames Laboratories, Wrexham, Wales".
Other bias Low risk Comment: no other source of bias.