| Methods |
Randomised clinical trial |
| Participants |
Country: Iran.
Number randomised: 93.
Post‐randomisation drop‐outs: not stated.
Revised sample size: 93.
Average age: not stated.
Females: not stated.
NASH: not stated.
Diabetics: not stated.
Average follow‐up period in months: 6.
Inclusion criteria
1. Diagnosis of NAFLD based on ultrasound.
2. Age 18 to 65 years. |
| Interventions |
Participants were randomly assigned to two groups.
Group 1: metformin plus antioxidants (N = 40).
Further details: metformin 1500 mg/day plus antioxidants: vitamin E 400 IU/day.
Group 2: metformin (N = 53).
Further details: metformin 1500 mg/day.
Duration of treatment: 6 months. Overweight people in both groups received weight loss advice. |
| Outcomes |
None of the outcomes of interest for this review 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: "A randomized clinical trial". |
| Allocation concealment (selection bias) |
Unclear risk |
Comment: this information was not available. |
| Blinding of participants and personnel (performance bias)
All outcomes |
High risk |
Quote: "open label". |
| Blinding of outcome assessment (detection bias)
All outcomes |
High risk |
Quote: "open label". |
| 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. |
