| Methods |
Randomised clinical trial |
| Participants |
Country: UK.
Number randomised: 48.
Post‐randomisation dropouts: 10 (20.8%).
Revised sample size: 38.
Average age: not stated
Females: not stated
Inclusion criteria: Biopsy confirmed ALD
Exclusion criteria: not reported |
| Interventions |
Participants were randomly assigned to two groups.
Group 1: ursodeoxycholic acid (I0 to 15 mg/kg/day).
Group 2: placebo.
Duration: 3 months |
| Outcomes |
None of the outcomes of interest were reported. |
| Notes |
Reasons for post‐randomisation dropouts: not stated. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Unclear risk |
Quote: "Randomized".
Comment: Further details were 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: there were post‐randomisation dropouts. |
| Selective reporting (reporting bias) |
High risk |
Comment: None of the outcomes of interest were reported. |
| For‐profit bias |
Unclear risk |
Comment: this information was not available. |
| Other bias |
Low risk |
Comment: there was no other bias. |
