| Methods |
Randomised clinical trial |
| Participants |
Country: Japan.
Number randomised: 10.
Post‐randomisation drop‐outs: not stated.
Revised sample size: 10.
Average age: 50 years.
Females: 7 (70%).
NASH: 10 (100%).
Diabetics: 10 (100%).
Average follow‐up period in months: 5.
Inclusion criteria
1. Biopsy proven NASH.
2. ALT > 30 UI/l.
3. Diabetes.
4. Ultrasound or CT proven liver steatosis.
Exclusion criteria
1. Alcohol intake > 20 g/day.
2. Hepatitis B or C.
3. ANA or AMA positivity. |
| Interventions |
Participants were randomly assigned to two groups.
Group 1: nateglinide (N = 5).
Further details: nateglinide 270 mg/day.
Group 2: control (N = 5).
Further details: control: no intervention.
Duration of treatment: 5 months. Both groups received dietary and physical activity advice |
| 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: "The subjects were randomly divided into two groups". |
| 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 |
Unclear risk |
Comment: this information was not available. |
| 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 |
Low risk |
Quote: "This study was supported by the grant 16590150 from the Ministry of Education, Science, Sports, and Culture of Japan and part of a project for establishing new high technology research center supported by the Ministry of Education, Science, Sports, and Culture of Japan". |
| Other bias |
Low risk |
Comment: no other risk of bias. |
