| Methods |
Randomised clinical trial |
| Participants |
Country: India.
Number randomised: 116.
Post‐randomisation drop‐outs: 0 (0%).
Revised sample size: 116.
Average age: not stated.
Females: not stated.
NASH: 116 (100%).
Diabetics: not stated.
Average follow‐up period in months: 12.
Inclusion criteria
1. Biopsy‐proven NASH. |
| Interventions |
Participants were randomly assigned to two groups.
Group 1: pentoxifylline and Antioxidants (N = 58).
Further details: pentoxifylline 400 mg thrice daily plus antioxidants: vitamin E 400 IU twice daily.
Group 2: antioxidants (N = 58).
Further details: antioxidants: vitamin E 400 IU twice daily.
Duration of treatment: 12 months. All people also underwent diet and lifestyle modification. |
| Outcomes |
None of the outcomes of interest were reported. |
| Notes |
|
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Unclear risk |
Quote: "Consecutive histologically proven patients with NASH were randomized to either". |
| Allocation concealment (selection bias) |
Unclear risk |
Comment: this information was not available. |
| Blinding of participants and personnel (performance bias)
All outcomes |
High risk |
Quote: "This is the first randomized open label trial". |
| Blinding of outcome assessment (detection bias)
All outcomes |
High risk |
Quote: "This is the first randomized open label trial". |
| Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
Comment: there were no post‐randomisation drop‐outs. |
| 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. |
