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

Epstein 1979.

Methods Randomised clinical trial.
Participants Country: UK.
Number randomised: 98.
Post‐randomisation dropouts: not stated.
Revised sample size: 98.
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): mean: 66 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: D‐penicillamine (n = 61).
Further details: D‐penicillamine: 600 mg/day to 900 mg/day for 12 months.
Group 2: placebo (n = 37).
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 High risk Quote: "The original double‐blind design of the trial was discontinued after a year because both major and minor side effects identified treated patients".
Blinding of outcome assessment (detection bias) 
 All outcomes High risk Quote: "The original double‐blind design of the trial was discontinued after a year because both major and minor side effects identified treated patients".
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 Unclear risk Comment: information not available.
Other bias Low risk Comment: no other source of bias.