| Methods |
Randomised clinical trial |
| Participants |
Country: USA.
Number randomised: 48.
Post‐randomisation drop‐outs: not stated.
Revised sample size: 48.
Average age: not stated.
Females: not stated.
NASH: 48 (100%).
Diabetics: not stated.
Average follow‐up period in months: 6.
Inclusion criteria
1. Biopsy proven NASH. |
| Interventions |
Participants were randomly assigned to two groups.
Group 1: pioglitazone (N = not stated).
Further details: pioglitazone 45 mg/day.
Group 2: control (N = not stated).
Further details: control: placebo.
Duration of treatment: 6 months. Both groups received hypocaloric diet. |
| Outcomes |
None of the outcomes of interest were reported. |
| 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: "Patients received a hypocaloric diet and were randomized (double‐blind) to PIO (45 mg/d) or placebo (Placebo) for 6 months". |
| Allocation concealment (selection bias) |
Unclear risk |
Comment: this information was not available. |
| Blinding of participants and personnel (performance bias)
All outcomes |
Low risk |
Quote: "double‐blind". |
| Blinding of outcome assessment (detection bias)
All outcomes |
Low risk |
Quote: "double‐blind". |
| 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 |
Unclear risk |
Comment: this information was not available. |
| Other bias |
Low risk |
Comment: no other risk of bias. |
