| Methods |
Randomised clinical trial |
| Participants |
Country: Iran.
Number randomised: 30.
Post‐randomisation drop‐outs: 3 (10%).
Revised sample size: 27.
Average age: 36 years.
Females: 6 (22.2%).
NASH: 27 (100%).
Diabetics: not stated.
Average follow‐up period in months: 6.
Inclusion criteria
1. Biopsy proven NASH.
2. Aged 15 to 60 years.
3. Liver function test alteration lasted for at least three months (AST and ALT > 1.2 times upper limit of normal).
Exclusion criteria
1. Alcohol consumption.
2. Viral hepatitis B or C.
3. Auto‐immune hepatitis.
4. Wilson's disease.
5. Haemochromatosis.
6. Alpha1‐antitrypsin deficiency.
7. Pregnancy, lactation or women who wished to have children in the following years.
8. Severe comorbidities (cardiac, pulmonary, renal or psychological). |
| Interventions |
Participants were randomly assigned to two groups.
Group 1: probucol (N = 18).
Further details: probucol 500 mg once daily.
Group 2: control (N = 9).
Further details: control: placebo.
Duration of treatment: 6 months. |
| Outcomes |
Outcomes reported: 1. Adverse events. |
| Notes |
Reasons for post‐randomisation drop‐outs: withdrew from study. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Low risk |
Quote: "Randomization was performed by a computer generated random list of the containers’ numbers". |
| Allocation concealment (selection bias) |
Low risk |
Quote: "Patients found eligible for the study in any of the three study centers were referred to a single investigator who assigned new cases sequentially to the next available container on the list". |
| Blinding of participants and personnel (performance bias)
All outcomes |
Low risk |
Quote: "a double‐blind randomized controlled study". |
| Blinding of outcome assessment (detection bias)
All outcomes |
Low risk |
Quote: "a double‐blind randomized controlled 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; mortality was not reported. |
| For‐profit bias |
Low risk |
Quote: "This work was funded by the Digestive Disease Research Center of Tehran University of Medical Sciences". |
| Other bias |
Low risk |
Comment: no other risk of bias. |
