Skip to main content
. 2017 Mar 28;2017(3):CD011343. doi: 10.1002/14651858.CD011343.pub2

Sterling 2004.

Methods Randomised clinical trial.
Participants Country: USA.
 Number randomised: 25.
 Post‐randomisation drop‐outs: 9 (36%).
 Revised sample size: 16.
 Mean age: 44 years.
 Females: 10 (62.5%).
Separate data for the subgroup with ulcerative colitis: no.
Inclusion criteria:
  1. Diagnosis of primary sclerosing cholangitis made by endoscopic retrograde cholangiopancreatography, magnetic resonance cholangiopancreatography, or liver biopsy.


Exclusion criteria:
  1. Evidence of secondary cholangitis.

  2. Chronic viral hepatitis (B or C), autoimmune or other metabolic liver conditions.

  3. Hepatobiliary malignancy.

  4. History of cholangitis within 3 months of study entry.

  5. Use of steroids or azathioprine within the preceding 3 months.

  6. History of liver decompensation (variceal bleeding, ascites, prolongation of prothrombin time > 2 seconds, or hepatic encephalopathy).


Follow‐up: 24 months.
Interventions Participants were randomly assigned to 1 of 2 groups.
 Group 1: mycophenolate mofetil 1000 mg twice/d and low‐dose UDCA (13–15 mg/kg/d) combined treatment over the period of follow‐up of the study (n = 6).
 Group 2: low‐dose UDCA (13–15 mg/kg/d) over the period of follow‐up of the study (n = 10).
Outcomes No outcomes of interest were reported.
Notes Reasons for post‐randomisation drop‐out:
  1. One participant in each group withdrew consent.

  2. One participant in the UDCA group moved away from the area.

  3. Two participants in the combination group discontinued the study drug for personal reasons unrelated to side effects.

  4. One participant in the combination group had recurrence of chronic sinusitis.

  5. Two participants in the combination group and 1 in the UDCA alone group had progression of their liver disease and subsequent referral for liver transplantation.

Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Comment: This information was not available.
Allocation concealment (selection bias) Low risk Quote: "Concealed randomisation via investigational pharmacy or by concealed envelopes" (study author's reply).
Blinding of participants and personnel (performance bias) 
 All outcomes High risk Quote: "Neither patient nor investigator was blinded to study medication".
Blinding of outcome assessment (detection bias) 
 All outcomes High risk Quote: "Neither patient nor investigator was blinded to study medication".
Incomplete outcome data (attrition bias) 
 All outcomes Unclear risk Quote: "All data were analysed by the intention‐to‐treat method".
Comment: Post‐randomisation drop‐outs were reported.
Selective reporting (reporting bias) High risk Comment: No published protocol was available; no outcomes of interest were reported.
For‐profit bias High risk Quote: "Supported in part by a NIH grant to the General Clinical Research Center of Virginia Commonwealth University Medical Center, M01‐RR‐00065‐35 and by the generous support of Roche Laboratory, Nutley, NJ and Axcan Scandipharm, Birmingham, AL, USA".
Comment: The trial was funded by a party with vested interest in the results (Roche produces mycophenolate mofetil).
Other bias Low risk Comment: no other bias.