| Methods |
Randomised clinical trial |
| Participants |
Country: Japan.
Number randomised: 25.
Post‐randomisation drop‐outs: 1 (4%).
Revised sample size: 24.
Average age: 57 years.
Females: 18 (75%).
NASH: 24 (100%).
Diabetics: not stated.
Average follow‐up period in months: 24.
Inclusion criteria
1. Biopsy proven NASH.
2. Impaired glucose tolerance or diabetes.
Exclusion criteria
1. Liver disease other than NAFLD.
2. Decompensated liver disease.
3. Alcohol consumption > 20 g per day.
4. Use of drugs associated with fatty liver. |
| Interventions |
Participants were randomly assigned to two groups.
Group 1: pioglitazone (N = 12).
Further details: pioglitazone 15 mg/day.
Group 2: control (N = 12).
Further details: control: no intervention.
Duration of treatment: 24 months. Both groups received dietary and physical activity advice. |
| Outcomes |
None of the outcomes of interest were reported in this trial. |
| Notes |
Reasons for post‐randomisation drop‐outs: lost to follow‐up. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Unclear risk |
Quote: "The subjects were randomly assigned to either a diet only group or diet plus pioglitazone". |
| Allocation concealment (selection bias) |
Unclear risk |
Quote: "a sealed envelope technique".
Comment: Further details were not available. |
| Blinding of participants and personnel (performance bias)
All outcomes |
High risk |
Quote: "No placebo was given to patients not given pioglitazone supplementation". |
| Blinding of outcome assessment (detection bias)
All outcomes |
Unclear risk |
Comment: although an identical placebo was used, there was no mention of blinding. |
| 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 |
Low risk |
Quote: "This work was supported by Grant‐in‐Aid for Young Scientists (B), no. 23790762, from the Ministry of Education, Culture, Sports, Science and Technology of Japan, and grants from Ministry of Health, Labor, and Welfare of Japan". |
| Other bias |
Low risk |
Comment: no other risk of bias. |
