| Methods |
Randomised clinical trial |
| Participants |
Country: Iran.
Number randomised: 100.
Post‐randomisation drop‐outs: not stated.
Revised sample size: 100.
Average age: 39 years.
Females: 43 (43%).
NASH: 100 (100%).
Diabetics: not stated.
Average follow‐up period in months: 6.
Inclusion criteria
1. Sonographic evidence of fatty liver.
2. Elevated ALT > 1.2 times of the normal.
3. Suggestive histological evidence of NASH.
4. Presence of strong risk factors such as type 2 diabetes or obesity (BMI > 30 kg/m²).
Exclusion criteria
1. Intake of ethanol > 20 g per day.
2. Use of drugs known to produce fatty liver disease (steroids, oestrogens, amiodarone, tamoxifen, or other chemotherapeutic agents ) in the previous 6 months.
3. Viral hepatitis B and C, auto‐immune hepatitis, Wilson’s disease, haemochromatosis, and alpha‐1 antitrypsin deficiency.
4. Severe comorbid medical conditions (cardiac, pulmonary, renal, or psychological problems). |
| Interventions |
Participants were randomly assigned to two groups.
Group 1: silymarin (N = 50).
Further details: silymarin 280 mg/day.
Group 2: control (N = 50).
Further details: control: placebo.
Duration of treatment: 6 months. |
| Outcomes |
None of the outcomes of interest were reported in this trial. |
| Notes |
Reasons for post‐randomisation drop‐outs: not stated. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Unclear risk |
Quote: "randomized controlled trial". |
| Allocation concealment (selection bias) |
Unclear risk |
Comment: this information was not available. |
| Blinding of participants and personnel (performance bias)
All outcomes |
Unclear risk |
Comment: although an identical placebo was used, there was no mention of blinding. |
| Blinding of outcome assessment (detection bias)
All outcomes |
Unclear risk |
Comment: although an identical placebo was used, there was no mention of blinding. |
| Incomplete outcome data (attrition bias)
All outcomes |
Unclear risk |
Comment: this information was not available. |
| Selective reporting (reporting bias) |
High risk |
Comment: protocol was not available; neither mortality nor adverse events were reported. |
| For‐profit bias |
Unclear risk |
Comment: this information was not available. |
| Other bias |
Low risk |
Comment: no other risk of bias. |
