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

Stiehl 1989.

Methods Randomised clinical trial.
Participants Country: Germany.
 Number randomised: 16.
 Post‐randomisation drop‐outs: 4 (25%).
 Revised sample size: 12.
 Mean age: data not available.
 Females: data not available.
Separate data for the subgroup with ulcerative colitis: no.
Inclusion criteria: not stated.
Exclusion criteria: not stated.
Follow‐up: unclear: definitive analysis planned for 12 months and interim analysis at 3 months.
Interventions Participants were randomly assigned to 1 of 2 groups.
 Group 1: low‐dose UDCA (8‐10 mg/kg/d) over the period of follow‐up of the study (n = 6).
 Group 2: placebo over the period of follow‐up of the study (n = 6).
Outcomes No outcomes of interest were reported.
Notes Reasons for post randomisation drop‐out not reported.
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 Comment: This information was 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) High 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.