| Methods |
Randomised clinical trial |
| Participants |
Country: Italy.
Number randomised: 50.
Post‐randomisation drop‐outs: 5 (10%).
Revised sample size: 45.
Average age: 44 years.
Females: 38 (84.4%).
NASH: not stated.
Diabetics: not stated.
Average follow‐up period in months: 6.
Inclusion criteria
1. Ultrasound proven NAFLD.
2. BMI more than 25 kg/m².
Exclusion criteria
1. Heart disease.
2. Renal failure.
3. Smoking habits.
4. Alcohol intake > 20 g/day.
5. Viral, autoimmune, metabolic or genetic liver diseases.
6. Drugs known for inducing liver steatosis. |
| Interventions |
Participants were randomly assigned to two groups.
Group 1: metformin (N = 20).
Further details: metformin 1 g per day.
Group 2: control (N = 25).
Further details: control: no intervention.
Duration of treatment: 6 months. Both groups received hypocaloric diet. |
| Outcomes |
Outcomes reported: Resolution of fatty liver. |
| Notes |
Reasons for post‐randomisation drop‐outs: non‐compliance to treatment. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Unclear risk |
Quote: "Patients were randomized into two groups". |
| 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 |
Low risk |
Quote: "All patients underwent US liver evaluation by a single experienced operator (M.D.S.), blinded to the clinical data". |
| Incomplete outcome data (attrition bias)
All outcomes |
High risk |
Comment: there were post‐randomisation drop‐outs, which may be related to the treatment that the participants received. |
| 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. |
