Skip to main content
. 2017 Mar 28;2017(3):CD011648. doi: 10.1002/14651858.CD011648.pub2

Matloff 1982.

Methods Randomised clinical trial.
Participants Country: USA.
Number randomised: 52.
Post‐randomisation dropouts: 0 (0%).
Revised sample size: 52.
Mean age: 52 years.
Females: 48 (92.3%).
Symptomatic participants: not stated.
AMA positive: 42 (80.8%).
Responders: not stated.
Mean follow‐up period (for all groups): minimum 24 months.
Inclusion criteria
  • Symptom status: not stated.

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

  • Response status: not stated.

Interventions Participants were randomly assigned to 2 groups.
Group 1: D‐penicillamine (n = 26).
Further details: D‐penicillamine: 1 g/day; duration: not stated.
Group 2: placebo (n = 26).
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 in this double‐blind trial, there was no mention about identical placebo.
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk Comment: although placebo was used in this double‐blind trial, there was no mention about identical placebo.
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 High risk Quote: "We are indebted to Merck, Sharp and Dohme Research Laboratories for providing the D‐penicillamine and placebo tablets".
Other bias Low risk Comment: no other bias.