| Methods |
Randomised clinical trial |
| Participants |
Country: Malaysia.
Number randomised: 64.
Post‐randomisation drop‐outs: not stated.
Revised sample size: 64.
Average age: 50 years.
Females: 36 (56.3%).
NASH: 64 (100%).
Diabetics: not stated.
Average follow‐up period in months: 11.
Inclusion criteria
1. Patients with NASH. |
| Interventions |
Participants were randomly assigned to two groups.
Group 1: silymarin (N = 30).
Further details: silymarin 700 mg thrice daily.
Group 2: control (N = 34).
Further details: control: placebo.
Duration of treatment: 11 months. |
| Outcomes |
Outcomes reported: 1. Cirrhosis. 2. Change in fibrosis score. 3. Change in NAS score. 4. Resolution of NASH. |
| 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: "This is a randomized, double‐blind, placebo‐controlled study of silymarin". |
| Allocation concealment (selection bias) |
Unclear risk |
Comment: this information was not available. |
| Blinding of participants and personnel (performance bias)
All outcomes |
Low risk |
Quote: "double‐blind". |
| Blinding of outcome assessment (detection bias)
All outcomes |
Low risk |
Quote: "double‐blind". |
| 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. |
