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
Exclusion criteria
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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). |
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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. |