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

Neuberger 1985.

Methods Randomised clinical trial.
Participants Country: multicentric; international.
Number randomised: 189.
Post‐randomisation dropouts: not stated.
Revised sample size: 189.
Mean age: not stated.
Females: 174 (92.1%).
Symptomatic participants: 172 (91%).
AMA positive: 163 (86.2%).
Responders: not stated.
Mean follow‐up period (for all groups): not stated.
Inclusion criteria
  • Symptom status: symptomatic and asymptomatic participants.

  • AMA status: AMA‐positive and AMA‐negative participants.

  • Response status: not stated.


Exclusion criteria
  • Taking azathioprine in the previous 6 months.

Interventions Participants were randomly assigned to 2 groups.
Group 1: D‐penicillamine (n = 98).
Further details: D‐penicillamine: 1200 mg/day; duration: not stated.
Group 2: placebo (n = 91).
Outcomes Mortality, liver transplantation.
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) Low risk Quote: "Opaque sealed envelopes" (author's reply).
Blinding of participants and personnel (performance bias) 
 All outcomes Low risk Quote: "Double blind trial, identical appearing placebo" (author's reply).
Blinding of outcome assessment (detection bias) 
 All outcomes Low risk Quote: "Assessors were blinded, identical placebo" (author's reply).
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 Quote: "Not pharmaceutical funding" (author's reply).
Other bias Low risk Comment: no other source of bias.