| Methods |
Randomised clinical trial |
| Participants |
Country: USA, Italy.
Number randomised: 55.
Post‐randomisation drop‐outs: 8 (14,5%).
Revised sample size: 47.
Average age: 51 years.
Females: 26 (55.3%).
NASH: 47 (100%).
Diabetics: 0 (0%).
Average follow‐up period in months: 6.
Inclusion criteria
1. Biopsy‐proven NASH.
2. Impaired glucose tolerance or type 2 diabetes mellitus (DM).
Exclusion criteria
1. AST and ALT elevated ≥ to 2.5 times the upper limit of normal.
2. History of alcohol use (> 1 drink per day).
3. Fasting glucose more or equal to 240 mg/dL.
4. Type 1 diabetes.
5. Heart disease.
6. Hepatic (other than NASH) disease.
7. Renal disease.
8. Metformin, thiazolidinediones or insulin use. |
| Interventions |
Participants were randomly assigned to two groups.
Group 1: pioglitazone (N = 26).
Further details: pioglitazone (30 mg/day increased to 45 mg/day after 2 months).
Group 2: control (N = 21).
Further details: control: placebo.
Duration of treatment: 6 months. All people also underwent dietary advice. |
| Outcomes |
Outcomes reported: 1. Cirrhosis 2. Resolution of fatty liver disease 3. Change in fibrosis score. |
| Notes |
Reasons for post‐randomisation drop‐outs: discontinued treatment, withdrew from study, developed medical complications. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Low risk |
Quote: "Randomization was computer‐generated by the research pharmacy". |
| Allocation concealment (selection bias) |
Low risk |
Quote: "Randomization was computer‐generated by the research pharmacy, and the investigators were unaware of the treatment assignments". |
| Blinding of participants and personnel (performance bias)
All outcomes |
Low risk |
Quote: "randomized, double‐blind, placebo controlled trial". |
| Blinding of outcome assessment (detection bias)
All outcomes |
Low risk |
Quote: "randomized, double‐blind, placebo controlled trial". |
| 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 |
High risk |
Quote: "Supported by grants from the National Center for Research Resources (MO1‐RR‐01346, to the Frederic C. Bartter General Clinical Research Center and its Imaging Core), Takeda Pharmaceuticals, and the Veterans Affairs Medical Research Fund". |
| Other bias |
Low risk |
Comment: no other risk of bias. |
