| Methods |
Randomised clinical trial |
| Participants |
Country: Cuba.
Number randomised: 60.
Post‐randomisation drop‐outs: 0 (0%).
Revised sample size: 60.
Average age: 47 years.
Females: 26 (43.3%).
NASH: 60 (100%).
Diabetics: not stated.
Average follow‐up period in months: 6.
Inclusion criteria
1. Biopsy proven NASH.
2. Age between 18 and 70 year old.
3. Weekly alcohol consumption < 20 g.
Exclusion criteria
1. Any other liver disease.
2. HBV or HCV positivity.
3. Pregnancy or lactation.
4. Decompensated cirrhosis.
5. Drug related NAFLD gastrointestinal by‐pass.
6. Treatment with UDCA, vitamin E, pioglitazone, betaine, rosiglitazone, metformin, pentoxyphilline or gemfibrozil.
7. Use of statin within the 6 month period before enrolment.
8. Fasting glucose level less than 250 mg/dL.
9. Contraindication to liver biopsy.
10. BMI more or equal to 35 kg/m².
11. Concomitant disease with reduced life expectancy.
12. Severe psychiatric conditions and drug dependence. |
| Interventions |
Participants were randomly assigned to two groups.
Group 1: antioxidants (N = 22).
Further details: antioxidants: visuid 50 g/day (antioxidant).
Group 2: control (N = 20).
Further details: control: no intervention.
Duration of treatment: 6 months. Both groups received hypocaloric diet and exercise advice. |
| Outcomes |
Outcomes reported: 1. Change in fibrosis score. 2. Change in NAFLD activity score. |
| Notes |
|
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Unclear risk |
Quote: "Randomization was conducted by blocks of 4". |
| 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: "Biopsy specimens were examined by a single pathologist who was unaware of the patients’ clinical and biochemical data, treatment assignment and liver biopsy sequence". |
| Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
Comment: there were no post‐randomisation drop‐outs.. |
| Selective reporting (reporting bias) |
High risk |
Comment: protocol was not available; neither mortality nor adverse events were reported. |
| For‐profit bias |
High risk |
Quote: "Supported in part by a grant from Catalysis Laboratories, Spain". |
| Other bias |
Low risk |
Comment: no other risk of bias. |
