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

Ma 2016.

Methods Randomised clinical trial.
Participants Country: China.
Number randomised: 199.
Post‐randomisation dropouts: 8 (4.0%).
Revised sample size: 191.
Mean age: 51 years.
Females: 167 (83.9%).
Symptomatic participants: 38 (19.9%).
AMA positive: 187 (97.9%).
Responders: not stated.
Mean follow‐up period (for all groups): all participants: 6 months.
Inclusion criteria
  • Symptom status: symptomatic and asymptomatic participants.

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

  • Response status: not stated.


Exclusion criteria
  • Advanced or decompensated liver disease.

  • Pregnancy or breastfeeding.

  • Other causes of liver diseases.

  • Serious comorbidities.

Interventions Participants were randomly assigned to 2 groups.
Group 1: UDCA (moderate) (n = 66).
Further details: UDCA: 250 mg 3 times daily for 24 weeks.
Group 2: TUDCA (moderate) (n = 125).
Further details: TUDCA: 250 mg 3 times daily for 24 weeks.
Outcomes Adverse events.
Notes Reason for drop‐outs: not reported.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: "A centralized telecommunication‐based interactive voice response system was used for patient randomization after patient eligibility was determined through clinical and laboratory screening assessments".
Allocation concealment (selection bias) Low risk Quote: "A centralized telecommunication‐based interactive voice response system was used for patient randomization after patient eligibility was determined through clinical and laboratory screening assessments".
Blinding of participants and personnel (performance bias) 
 All outcomes Low risk Comment: identical placebo used in this double‐blind trial.
Blinding of outcome assessment (detection bias) 
 All outcomes Low risk Comment: identical placebo used in this double‐blind trial.
Incomplete outcome data (attrition bias) 
 All outcomes Unclear risk Comment: unclear whether all participants were included in the analysis.
Selective reporting (reporting bias) High risk Comment: mortality not reported.
For‐profit bias High risk Quote: "This study was sponsored by the Beijing Trendful Kangjian Medical Information Consulting Co., Ltd. and the Major Science and Technology Special Project of China Twelfth Five‐year Plan (2012ZX10002003). Registration Number: NCT01829698".
Other bias Low risk Comment: no other source of bias.