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:
Exclusion criteria: not stated. Follow‐up: 12 months. |
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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:
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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. |