| Methods |
Randomised clinical trial |
| Participants |
Country: Switzerland.
Number randomised: 48.
Post‐randomisation drop‐outs: 8 (16.7%).
Revised sample size: 40.
Average age: not stated.
Females: not stated.
NASH: 40 (100%).
Diabetics: not stated.
Average follow‐up period in months: 24.
Inclusion criteria
1. Aged between 18 and 75 years.
2. Biopsy proven NASH performed within 6 months from inclusion.
3. Persistent elevation of ALT levels of at least 1.5 times the upper limit of normal.
4. Weekly alcohol consumption < 40 g.
Exclusion criteria
1. Positive screening for B or C viral hepatitis.
2. Abnormal transferrin saturation.
3. ANA title more than 1:80.
4. Histologic findings suggestive of other liver diseases.
5. Decompensated cirrhosis.
6. Serious diseases limiting life expectancy.
7. Pregnancy or lactation.
8. Treatment with NASH‐inducing drugs (amiodarone, calcium channel blockers, tamoxifen) or oral anticoagulant. |
| Interventions |
Participants were randomly assigned to three groups.
Group 1: UDCA plus antioxidants (N = 12).
Further details: UDCA 12 ‐ 15 mg/kg/day plus antioxidants: vitamin E 400 IU twice daily.
Group 2: UDCA (N = 15).
Further details: UDCA 12 to 15 mg/kg/day.
Group 3: control (N = 13).
Further details: control: placebo.
Duration of treatment: 6 months. All people also underwent dietary advice. |
| Outcomes |
Outcomes reported: 1. Change in fibrosis scores. |
| Notes |
Reasons for post‐randomisation drop‐outs: did not have paired biopsy. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Unclear risk |
Quote: "The pharmacy established before the start of the study a list randomly assigning each patient to 1 of the 3 arms of the study".
Comment: Further details were not available. |
| Allocation concealment (selection bias) |
Low risk |
Quote: "The pharmacy established before the start of the study a list randomly assigning each patient to 1 of the 3 arms of the study". |
| Blinding of participants and personnel (performance bias)
All outcomes |
Low risk |
Quote: "The patients as well as their physicians were blinded to the treatment until completion of the whole study". |
| Blinding of outcome assessment (detection bias)
All outcomes |
Low risk |
Quote: "The patients as well as their physicians were blinded to the treatment until completion of the whole study". |
| 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: "Capsules containing UDCA 250 mg and placebo capsules were provided by Falk Pharma GmH (Freiburg, Germany). Tablets containing vitamin E (natural d‐tocopherol) 400 IU and placebo tablets were provided by Antistress AG (Rapperswil, Switzerland)". |
| Other bias |
Low risk |
Comment: no other risk of bias. |
