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

Mitchison 1993.

Methods Randomised clinical trial.
Participants Country: multicentric; international.
Number randomised: 104.
Post‐randomisation dropouts: 3 (2.9%).
Revised sample size: 101.
Mean age: 54 years.
Females: 93 (92.1%).
Symptomatic participants: 101 (100%).
AMA positive: not stated.
Responders: not stated.
Median follow‐up period (for all groups): 25 months.
Inclusion criteria

  • Symptom status: symptomatic participants only.

  • AMA status: not stated.

  • Response status: not stated.


Exclusion criteria

  • Aged > 65 years.

  • Immunosuppressive drugs in the preceding 6 months.

  • Advanced liver disease or decompensated liver disease.
Interventions Participants were randomly assigned to 2 groups.
Group 1: malotilate (n = 52).
Further details: malotilate: 500 mg 3 times daily; mean duration: 23 months.
Group 2: placebo (n = 49).
Outcomes Mortality, adverse events.
Notes Reasons for post‐randomisation dropouts: elementary data not available.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: "Random sequence was generated by the trial statistician with tables with random numbers" (author's reply).
Allocation concealment (selection bias) Low risk Quote: "Sequentially numbered identical containers" (author's reply).
Blinding of participants and personnel (performance bias) 
 All outcomes Low risk Quote: "Both patients and doctors were unaware of the nature of the tablets".
 Comment: placebo used to achieve blinding.
Blinding of outcome assessment (detection bias) 
 All outcomes Low risk Quote: "Both patients and doctors were unaware of the nature of the tablets".
 Comment: placebo used to achieve blinding.
Incomplete outcome data (attrition bias) 
 All outcomes High risk Comment: there were post‐randomisation dropouts.
Selective reporting (reporting bias) Low risk Comment: mortality and morbidity reported.
For‐profit bias High risk Quote: "The study was supported in part by Zyma S.A., Nyon, Switzerland, and by Nihon Nohyaku, Tokyo, Japan".
Other bias Low risk Comment: no other source of bias.