Triger 1980.
Methods | Randomised clinical trial. | |
Participants | Country: UK. Number randomised: 35. Post‐randomisation dropouts: not stated. Revised sample size: 35. 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): not stated. Inclusion criteria
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Interventions | Participants were randomly assigned to 2 groups. Group 1: D‐penicillamine (n = not stated). Further details: D‐penicillamine: 250 mg to 875 mg (escalating dose). Group 2: placebo (n = not stated). |
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Outcomes | Mortality. | |
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: in this double‐blind trial, unclear whether the placebo was identical to active treatment. |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Comment: in this double‐blind trial, unclear whether the placebo was identical to active treatment. |
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 | High risk | Quote: "The UDCA and placebo tablets were generously donated by Thames Laboratories, Wrexham, Wales". |
Other bias | Low risk | Comment: no other source of bias. |