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

Gao 2012.

Methods Randomised clinical trial.
Participants Country: China.
Number randomised: 79.
Post‐randomisation dropouts: not stated.
Revised sample size: 79.
Mean age: 53 years.
Females: 77 (97.5%).
Symptomatic participants: not stated.
AMA positive: not stated.
Responders: not stated.
Mean follow‐up period (for all groups): not stated.
Inclusion criteria
  • Symptom status: not stated.

  • AMA status: not stated.

  • Response status: not stated.


Other inclusion criteria
  • Only people with Sjogren's syndrome were included.


Exclusion criteria
  • People with decompensated cirrhosis.

  • Aged > 70 years.

  • Other autoimmune diseases.

Interventions Participants were randomly assigned to 3 groups.
Group 1: UDCA (moderate) (n = 29).
Further details: UDCA: 13 mg/kg/day to 15 mg/kg/day; duration: not stated.
Group 2: UDCA (moderate) + glucocorticosteroids (n = 37).
Further details: UDCA: 13 mg/kg/day to 15 mg/kg/day; duration: not stated + prednisolone: 7.5 mg/day; duration: not stated.
Group 3: UDCA (moderate) + azathioprine (n = 13).
Further details: UDCA: 13 mg/kg/day to 15 mg/kg/day; duration: not stated + azathioprine: 1 mg/kg/day; duration: not stated.
Outcomes Adverse events, decompensated liver disease.
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: information not available.
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk Comment: information not available.
Incomplete outcome data (attrition bias) 
 All outcomes Unclear risk Comment: information not available.
Selective reporting (reporting bias) High risk Comment: mortality not reported.
For‐profit bias Unclear risk Comment: information not available.
Other bias Low risk Comment: no other source of bias.