| Methods |
Randomised clinical trial |
| Participants |
Country: Italy.
Number randomised: 200.
Post‐randomisation drop‐outs: 4 (2%).
Revised sample size: 196.
Average age: 62 years.
Females: 92 (46.9%).
NASH: not stated.
Diabetics: 0 (0%).
Average follow‐up period in months: 12.
Inclusion criteria
1. Biopsy proven NAFLD.
Exclusion criteria
1. History of HBV or HCV infection.
2. Gallstones.
3. Alcohol consumption.
4. Renal failure.
5. Diabetes. |
| Interventions |
Participants were randomly assigned to four groups.
Group 1: UDCA plus antioxidants (N = 52).
Further details: UDCA (300 mg/day) plus antioxidants: alpha lipoic acid (400 mg/ day).
Group 2: antioxidants (N = 52).
Further details: antioxidants: alpha lipoic acid (400 mg/ day).
Group 3: UDCA (N = 46).
Further details: UDCA (300 mg/day).
Group 4: control (N = 46).
Further details: control: no intervention.
Duration of treatment: 12 months. All four groups received hypocaloric diet. |
| Outcomes |
Outcomes reported: 1. NAFLD activity score. |
| Notes |
Reasons for post‐randomisation drop‐outs: onset of diabetes. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Low risk |
Quote: "computerized random numbers". |
| Allocation concealment (selection bias) |
Low risk |
Quote: "The ALA and UDCA were in capsule forms and were identical in appearance. They were prepared in bottles and consecutively numbered for each patient, according to the randomization schedule". |
| Blinding of participants and personnel (performance bias)
All outcomes |
Low risk |
Quote: "double‐blind, randomized clinical trial ". |
| Blinding of outcome assessment (detection bias)
All outcomes |
Low risk |
Quote: "double‐blind, randomized clinical trial ".
Comment: this information was not available. |
| 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. |
