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. |