| Methods |
Randomised clinical trial |
| Participants |
Country: France.
Number randomised: 64.
Post‐randomisation drop‐outs: 1 (1,6%).
Revised sample size: 63.
Average age: 54 years.
Females: 26 (41.3%).
NASH: 63 (100%).
Diabetics: 20 (31.7%).
Average follow‐up period in months: 16.
Inclusion criteria
1. Aged 18 to 75 years.
2. Biopsy proven NASH (and steatosis > 20%).
3. Elevated ALT (> 28 UI/L for women and > 35 UI/L for men at baseline and at least 2 abnormal values in the last 6 months).
Exclusion criteria
1 .Presence of bland steatosis on liver biopsy or steatosis with no specific inflammation.
2. Daily alcohol consumption > 30 g in men and 20 g in women whether current or in the past.
3. Any cause of liver disease other than NASH, including suspicion of drug‐induced liver injury (introduction of a new drug in the past 6 months without prior documentation of elevated ALT level).
4. Treatment with insulin for diabetes or with ursodeoxycholic acid.
5. Cardiac insufficiency (NYHA class I).
6. Current or past treatment with drugs that can induce steatohepatitis.
7. Neoplastic disease.
8. Child B or C cirrhosis.
9. Pregnancy.
10. Organ transplantation.
11. Haemoglobin level < 10 g/dL.
12. Polymorphonuclear count < 750/mm³.
13. Platelet count < 50,000/mm³ |
| Interventions |
Participants were randomly assigned to two groups.
Group 1: rosiglitazone (N = 32).
Further details: rosiglitazone 4 mg/day for 1 month increased to 8 mg/day thereafter.
Group 2: control (N = 31).
Further details: control: placebo.
Duration of treatment: 12 months. Both groups received dietary and physical activity advice |
| Outcomes |
Outcomes reported: 1. Change in fibrosis score 2. Change in NAFLD activity score. |
| Notes |
Reasons for post‐randomisation drop‐outs: withdrew consent. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Unclear risk |
Quote: "Randomization (presealed envelopes) was conducted by blocks of 4 and stratified on metformin use". |
| Allocation concealment (selection bias) |
Unclear risk |
Quote: "Randomization (presealed envelopes) was conducted by blocks of 4 and stratified on metformin use".
Comment: Further details were not available. |
| 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: "GlaxoSmithKline provided rosiglitazone and placebo for this trial and partly funded the trial". |
| Other bias |
Low risk |
Comment: no other risk of bias. |
