| Methods |
Randomised clinical trial |
| Participants |
Country: Brasil.
Number randomised: 30.
Post‐randomisation drop‐outs: not stated.
Revised sample size: 30.
Average age: 38 years.
Females: 2 (6.7%).
NASH: not stated.
Diabetics: not stated.
Average follow‐up period in months: 3.
Inclusion criteria
1. BMI ≥ 25.
2. ALT, AST or GGT ≥ 1.5 times the upper limit of normal for more than six months.
3. Ultrasound proven liver steatosis.
Exclusion criteria
1. Alcohol consumption > 40 g/week.
2. Decompensated diabetes.
3. Total cholesterol or triglycerides more than 300 mg/dL.
4. Intake of hepatotoxic medications.
5. HBV or HCV infection.
6. Other concomitant hepatic or systemic diseases. |
| Interventions |
Participants were randomly assigned to two groups.
Group 1: UDCA (N = 15).
Further details: UDCA 10 mg/kg/day.
Group 2: control (N = 15).
Further details: control: placebo.
Duration of treatment: 3 months. |
| Outcomes |
No outcomes of interest were reported in this trial. |
| Notes |
Reasons for post‐randomisation drop‐outs: not stated. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Unclear risk |
Quote: "randomized double‐blind study". |
| Allocation concealment (selection bias) |
Unclear risk |
Comment: this information was not available. |
| Blinding of participants and personnel (performance bias)
All outcomes |
Low risk |
Quote: "randomized double‐blind study". |
| Blinding of outcome assessment (detection bias)
All outcomes |
Low risk |
Quote: "randomized double‐blind study". |
| Incomplete outcome data (attrition bias)
All outcomes |
Unclear risk |
Comment: this information was not available. |
| Selective reporting (reporting bias) |
High risk |
Comment: protocol was not available; neither mortality nor adverse events were reported. |
| For‐profit bias |
High risk |
Quote: "Ursodeoxycholic acid was kindly provided by Zambon Laboratories, São Paulo, SP, Brazil". |
| Other bias |
Low risk |
Comment: no other risk of bias. |
