Methods |
Randomised clinical trial |
Participants |
Country: Iran.
Number randomised: 100.
Post‐randomisation drop‐outs: not stated.
Revised sample size: 100.
Average age: 38 years.
Females: 24 (24%).
NASH: not stated.
Diabetics: not stated.
Average follow‐up period in months: 2.
Inclusion criteria
1. US fatty liver.
2. Persistently elevated ALT.
Exclusion criteria
1. Causes of liver disease other than NAFLD. |
Interventions |
Participants were randomly assigned to two groups.
Group 1: antioxidants (N = not stated).
Further details: antioxidants: vitamin E 400 IU/day.
Group 2: silymarin (N = not stated).
Further details: silymarin 140 mg/day.
Duration of treatment: 2 months. |
Outcomes |
None of the outcomes of interest were reported. |
Notes |
Reasons for post‐randomisation drop‐outs: not stated. |
Risk of bias |
Bias |
Authors' judgement |
Support for judgement |
Random sequence generation (selection bias) |
Unclear risk |
Quote: "They were randomly assigned to take…". |
Allocation concealment (selection bias) |
Unclear risk |
Comment: this information was not available. |
Blinding of participants and personnel (performance bias)
All outcomes |
Low risk |
Quote: "double‐blind". |
Blinding of outcome assessment (detection bias)
All outcomes |
Low risk |
Quote: "double‐blind". |
Incomplete outcome data (attrition bias)
All outcomes |
Unclear risk |
Comment: this information was not available. |
Selective reporting (reporting bias) |
High risk |
Comment: protocol was not available; neither mortality nor adverse events were reported. |
For‐profit bias |
Unclear risk |
Comment: this information was not available. |
Other bias |
Low risk |
Comment: no other risk of bias. |