Methods |
Randomised clinical trial |
Participants |
Country: Hungary.
Number randomised: 36.
Post‐randomisation dropouts: not stated.
Revised sample size: 36.
Average age: 46 years.
Females: 9 (25%).
Inclusion criteria: ALD
Exclusion criteria: other causes of liver disease |
Interventions |
Participants were randomly assigned to two groups.
Group 1 (n = 17): silymarin 140 mg thrice daily.
Group 2 (n = 19): placebo.
Duration: 6 months treatment |
Outcomes |
adverse events. |
Notes |
|
Risk of bias |
Bias |
Authors' judgement |
Support for judgement |
Random sequence generation (selection bias) |
Unclear risk |
Quote: "Random code".
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 |
Quote: "Double‐blind".
Comment: Further details were not available. |
Blinding of outcome assessment (detection bias)
All outcomes |
Unclear risk |
Quote: "Double‐blind".
Comment: Further details were not available. |
Incomplete outcome data (attrition bias)
All outcomes |
Unclear risk |
Comment: this information was not available. |
Selective reporting (reporting bias) |
High risk |
Comment: mortality was not reported. |
For‐profit bias |
Unclear risk |
Comment: this information was not available. |
Other bias |
Low risk |
Comment: there was no other bias. |