| Methods |
Randomised clinical trial |
| Participants |
Country: Turkey.
Number randomised: 57.
Post‐randomisation drop‐outs: 1 (1.8%).
Revised sample size: 56.
Average age: 47 years.
Females: 23 (41.1%).
NASH: 6 (10.7%).
Diabetics: 14 (25%).
Average follow‐up period in months: 6.
Inclusion criteria
1. ALT levels at least 1.2 times the upper limit of normal despite a three‐month weight reducing diet.
2. Biopsy proven NAFLD.
Exclusion criteria
1. Alcohol intake > 20 g/day.
2. Viral hepatitis B and C.
3. Other hepatic diseases including auto‐immune hepatitis, Wilson's disease, haemochromatosis and alpha‐1 antitrypsin deficiency.
4. Severe cardiac, pulmonary, renal or psychological problems. |
| Interventions |
Participants were randomly assigned to two groups.
Group 1: UDCA (N = 29).
Further details: UDCA 10 mg/kg/day.
Group 2: antioxidants (N = 27).
Further details: antioxidants: vitamin E 600 IU/day and vitamin C 500 mg/day.
Duration of treatment: 6 months. |
| Outcomes |
Outcomes reported: 1. Adverse events 2. Resolution of fatty liver disease. |
| Notes |
Reasons for post‐randomisation drop‐outs: discontinued participation. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Unclear risk |
Quote: "prospective, open‐label, randomized". |
| Allocation concealment (selection bias) |
Unclear risk |
Comment: this information was not available. |
| Blinding of participants and personnel (performance bias)
All outcomes |
High risk |
Quote: "prospective, open‐label, randomized". |
| Blinding of outcome assessment (detection bias)
All outcomes |
High risk |
Quote: "prospective, open‐label, randomized". |
| 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. |
