| Methods |
Randomised clinical trial |
| Participants |
Country: USA.
Number randomised: 283.
Post‐randomisation drop‐outs: not stated.
Revised sample size: 283.
Average age: 51 years.
Females: 187 (66.1%).
NASH: 283 (100%).
Diabetics: 149 (52.7%).
Average follow‐up period in months: 17.
Inclusion criteria
1. Aged ≥ 18 years at the time of screening.
2. Histological evidence of definite or borderline non‐alcoholic steatohepatitis based upon a liver biopsy obtained 90 days or less before randomisation.
3. NAS score ≥ 4 with a score ≥ 1 in each component of the score.
Exclusion criteria
1. Presence of cirrhosis.
2. Other causes of liver disease.
3. Substantial alcohol consumption (> 20 g/day for women or > 30 g/day for men).
4. Other confounding conditions. |
| Interventions |
Participants were randomly assigned to two groups.
Group 1: obeticholic acid (N = 141).
Further details: obeticholic acid 25 mg OD.
Group 2: control (N = 142).
Further details: control: placebo.
Duration of treatment: 17 months. |
| Outcomes |
Outcomes reported: 1. Mortality 2. Adverse events 3. Change in fibrosis score 4. Change in NAS score. 5. Resolution of fatty liver disease. |
| Notes |
Reasons for post‐randomisation drop‐outs: not stated. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Low risk |
Quote: "computer‐generated, centrally administered procedure". |
| Allocation concealment (selection bias) |
Low risk |
Quote: "computer‐generated, centrally administered procedure.Treatment was assigned centrally using a web‐based application". |
| Blinding of participants and personnel (performance bias)
All outcomes |
Low risk |
Quote: "Patients, investigators, clinical site staff, and pathologists were masked to treatment assignment". |
| Blinding of outcome assessment (detection bias)
All outcomes |
Low risk |
Quote: "Patients, investigators, clinical site staff, and pathologists were masked to treatment assignment". |
| Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
Comment: all participants were included for safety issues and non‐histological outcomes but 64 participants were excluded for histological outcomes. |
| Selective reporting (reporting bias) |
Low risk |
Comment: mortality and adverse events were reported. |
| For‐profit bias |
High risk |
Quote: "National Institute of Diabetes and Digestive and Kidney Diseases, Intercept Pharmaceuticals". |
| Other bias |
Low risk |
Comment: no other risk of bias. |
