| Methods |
Randomised clinical trial |
| Participants |
Country: USA.
Number randomised: 80.
Post‐randomisation drop‐outs: not stated.
Revised sample size: 80.
Average age: not stated.
Females: not stated.
NASH: not stated.
Diabetics: not stated.
Average follow‐up period in months: not stated.
Inclusion criteria
1. CT proven hepatic steatosis.
Exclusion criteria
1. Coronary artery disease.
2. Insulin‐dependent diabetes.
3. Bleeding diathesis.
4. Severe anaemia.
5. Cancer within past 5 years. |
| Interventions |
Participants were randomly assigned to two groups.
Group 1: atorvastatin plus antioxidants (N = 44).
Further details: atorvastatin 20 mg/day plus vitamin C 1 g/day plus vitamin E 1,000 U/day.
Group 2: control (N = 36).
Further details: control: placebo.
Duration of treatment: not reported. |
| Outcomes |
None of the outcomes of interest were reported in this trial. |
| Notes |
|
| 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 |
Low risk |
Quote: "double‐blind, placebo‐controlled". |
| Blinding of outcome assessment (detection bias)
All outcomes |
Low risk |
Quote: "double‐blind, placebo‐controlled". |
| 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. |
