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. 2017 Mar 28;2017(3):CD011648. doi: 10.1002/14651858.CD011648.pub2

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
  • Symptom status: symptomatic and asymptomatic participants.

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

  • Response status: not stated.


Exclusion criteria
  • Did not take UDCA in the previous 3 months.

  • Decompensated cirrhosis.

  • Required renal dialysis.

  • Pregnant or nursing.

  • Had a serious illness of other types such as uncontrolled congestive heart failure, severe diabetic neuropathy, severe pulmonary disease, advanced cancer, etc.

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).
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.