| Methods |
Randomised clinical trial |
| Participants |
Country: France.
Number randomised: 126.
Post‐randomisation drop‐outs: 0 (0%).
Revised sample size: 126.
Average age: 50 years.
Females: 31 (24.6%).
NASH: 126 (100%).
Diabetics: 40 (31.7%).
Average follow‐up period in months: 12.
Inclusion criteria
1. Aged > 18 years.
2. Increased ALT (≥ 50 UI/L) in at least three determinations within the past 12 months.
3. Biopsy proven NASH.
Exclusion criteria
1. > one normal ALT level within the 12 months before screening.
2. No inflammation on liver biopsy which excluded the diagnosis of NASH.
3. Alcohol consumption > 30 g/day for men and 20 g/day for women.
4. Liver diseases other than NAFLD.
5. Child B or C cirrhosis.
6. Secondary NASH.
7. Treatment with UDCA in the previous 12 months, with vitamin E in the previous 6 months or with glitazone in the previous 3 months.
8. Newly instituted antihyperglycaemic therapy in the previous 4 months.
9. Loss ≥ 15% body weight since liver biopsy.
10. Hepatocellular carcinoma.
11. Pregnancy or breastfeeding. |
| Interventions |
Participants were randomly assigned to two groups.
Group 1: UDCA (N = 62).
Further details: UDCA 28 to 35 mg/kg/day.
Group 2: control (N = 64).
Further details: control: placebo.
Duration of treatment: 12 months. Both groups received dietary and physical activity advice. |
| Outcomes |
Outcomes reported: 1. Mortality. 2. Adverse events. 3. Decompensated cirrhosis. |
| Notes |
|
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Unclear risk |
Quote: "This multicenter, randomized, double‐blind, parallel arm, placebo‐controlled phase II study of HD‐UDCA was conducted in 15 centers in France". |
| Allocation concealment (selection bias) |
Unclear risk |
Comment: this information was not available. |
| Blinding of participants and personnel (performance bias)
All outcomes |
Low risk |
Quote: "This multicenter, randomized, double‐blind, parallel arm, placebo‐controlled phase II study of HD‐UDCA was conducted in 15 centers in France". |
| Blinding of outcome assessment (detection bias)
All outcomes |
Low risk |
Quote: "This multicenter, randomized, double‐blind, parallel arm, placebo‐controlled phase II study of HD‐UDCA was conducted in 15 centers in France". |
| Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
Comment: there were no post‐randomisation drop‐outs. |
| Selective reporting (reporting bias) |
Low risk |
Comment: mortality and adverse events were reported. |
| For‐profit bias |
High risk |
Quote: "This trial was sponsored and funded by Axcan Pharma S.A. V. Ratziu is a consultant to Astellas Pharma, Axcan Pharma, Gilead Sciences, Genentech, Intercept Pharmaceuticals, and Sanofi‐Aventis". |
| Other bias |
Low risk |
Comment: no other risk of bias. |
