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
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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). |
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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. |