Askari 2010.
Methods | Randomised clinical trial. | |
Participants | Country: USA. Number randomised: 28. Post‐randomisation dropouts: 0 (0%). Revised sample size: 28. Mean age: 54 years. Females: 26 (92.9%). Symptomatic participants: not stated. AMA positive: 27 (96.4%). 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: tetrathiomolybdate (n = 13). Further details: tetrathiomolybdate: 10 mg/day to 120 mg/day based on serum ceruloplasmin levels; duration: not stated. Group 2: placebo (n = 15). |
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Outcomes | None of the outcomes of interest reported. | |
Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "The patients were assigned to the placebo arm or the tetrathiomolybdate arm using a table of random numbers". |
Allocation concealment (selection bias) | Low risk | Quote: "Central allocation by pharmacy" (author's reply). |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Comment: identical placebo used and authors stated double‐blind. |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Comment: identical placebo used and authors stated double‐blind. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Quote: "There were not post‐randomisation drop‐outs" (author's reply). |
Selective reporting (reporting bias) | High risk | Comment: neither mortality nor adverse events reported. |
For‐profit bias | Low risk | Quote: "Supported by Grant FD‐02590‐02 from the U.S. Food and Drug Administration's Orphan Products Office, the General Clinical Research Center of the University of Michigan Hospitals, Grant MO1‐ RR000042 from the National Institutes of Health, and Grant Ul1‐ RR024986 Clinical and Translational Science Awards". |
Other bias | High risk | Comment: unclear whether the participants continued to take UDCA in both groups. |