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. 2017 Mar 28;2017(3):CD011343. doi: 10.1002/14651858.CD011343.pub2

Bansi 1996.

Methods Randomised clinical trial.
Participants Country: UK.
 Number randomised: 23.
 Post‐randomisation drop‐outs: 1 (4.3%).
 Revised sample size: 22.
 Mean age: 53 years.
 Females: 7 (31.8%).
Separate data for the subgroup with ulcerative colitis: no.
Inclusion criteria:
  1. Diagnosis of primary sclerosing cholangitis.

  2. Pre‐trial biopsy and cholangiography.


Exclusion criteria: not stated.
Follow‐up: 12 months.
Interventions Participants were randomly assigned to 1 of 2 groups.
 Group 1: moderate‐dose UDCA (20 mg/kg/d) over the period of follow‐up of the study (n = 11).
 Group 2: placebo over the period of follow‐up of the study (n = 11).
Outcomes No outcomes of interest were reported.
Notes Reasons for post‐randomisation drop‐out:
  1. Dominant bile duct stricture that required stenting (UDCA group).

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) Unclear risk Comment: This information was not available.
Blinding of participants and personnel (performance bias) 
 All outcomes Unclear risk Quote: "Double‐blind placebo‐controlled trial".
Comment: Further details were not available.
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk Comment: This information was not available.
Incomplete outcome data (attrition bias) 
 All outcomes High risk Comment: Post‐randomisation drop‐outs may be related to the treatment that participants received.
Selective reporting (reporting bias) Unclear risk Comment: No published protocol was available; no outcomes of interest were reported.
For‐profit bias Unclear risk Comment: This information was not available.
Other bias Low risk Comment: no other bias.