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

Macklon 1982.

Methods Randomised clinical trial.
Participants Country: UK.
Number randomised: 60.
Post‐randomisation dropouts: 0 (0%).
Revised sample size: 60.
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): 37 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 = 41).
Further details: D‐penicillamine: 250 mg/day or 1 g/day; duration: not stated.
Group 2: placebo (n = 19).
Outcomes Mortality, adverse events.
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 was used, there is no mention of blinding.
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk Comment: although placebo was used, there is no mention of blinding.
Incomplete outcome data (attrition bias) 
 All outcomes Low risk Comment: no post‐randomisation dropouts.
Selective reporting (reporting bias) Low risk Comment: mortality and morbidity reported.
For‐profit bias Unclear risk Comment: information not available.
Other bias Low risk Comment: no other bias.