| Methods |
Randomised clinical trial |
| Participants |
Country: Iran.
Number randomised: 80.
Post‐randomisation drop‐outs: 0 (0%).
Revised sample size: 80.
Average age: 35 years.
Females: 12 (15%).
NASH: not stated.
Diabetics: 6 (7.5%).
Average follow‐up period in months: 4.
Inclusion criteria
1. Aged ≥ 18 years.
2. Ultrasound proven NAFLD.
3. Persistently elevated transaminases (≥ 40 UI/L).
4. NAFLD liver fat score > ‐0.64.
Exclusion criteria
1. Alcohol consumption > 20 g/day for men and 10 g/day for women.
2. Type 1 diabetes.
3. Heart disease.
4. Liver diseases (viral hepatitis, auto‐immune hepatitis, Wilson disease, haemochromatosis, liver mass lesion).
5. Renal disease (creatinine > 1.5 mg/dL).
6. Severe systemic comorbidities.
7. Neoplasm.
8. Any medication in the previous 3 months.
9. Previous treatment with thiazolinediones, biguanides or insulin.
10. Pregnancy or breastfeeding. |
| Interventions |
Participants were randomly assigned to two groups.
Group 1: metformin (N = 40).
Further details: metformin 1 g per day.
Group 2: pioglitazone (N = 40).
Further details: pioglitazone 30 mg/day.
Duration of treatment: 4 months. Both groups received hypocaloric diet |
| Outcomes |
Outcomes reported: 1. Mortality. 2. Adverse events. 3. Cirrhosis. 4. Decompensated liver disease. 5. Liver transplantation. |
| Notes |
Authors provided additional information in February 2016. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Low risk |
Quote: "predefined computer‐generated block randomization table". |
| Allocation concealment (selection bias) |
Low risk |
Quote: "An investigator who was not involved in data collection and treatment, performed the enrolment patients and their assignments into treatment groups". |
| Blinding of participants and personnel (performance bias)
All outcomes |
Low risk |
Quote: "randomized double blind clinical trial". |
| Blinding of outcome assessment (detection bias)
All outcomes |
Low risk |
Quote: "randomized double blind clinical trial". |
| Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
Comment: there were no post‐randomisation drop‐outs. |
| Selective reporting (reporting bias) |
Low risk |
Comment: mortality and adverse events were reported. |
| For‐profit bias |
Low risk |
Quote: "This study was supported by the research funds of Kashan University of Medical Sciences (No: 29‐5‐1‐2851)". |
| Other bias |
Low risk |
Comment: no other risk of bias. |
