| Methods |
Randomised clinical trial |
| Participants |
Country: Romania.
Number randomised: 94.
Post‐randomisation drop‐outs: not stated.
Revised sample size: 94.
Average age: 49 years.
Females: 44 (46.8%).
NASH: 94 (100%).
Diabetics: not stated.
Average follow‐up period in months: 12.
Inclusion criteria
1. Biopsy proven NASH.
Exclusion criteria
1. Liver diseases other than NAFLD.
2. Insulin treatment.
3. Renal failure. |
| Interventions |
Participants were randomly assigned to three groups.
Group 1: pentoxifylline (N = 32).
Further details: pentoxifylline 1200 mg/day.
Group 2: UDCA (N = 30).
Further details: UDCA 13 mg/kg/day.
Group 3: pentoxifylline plus UDCA (N = 32).
Further details: pentoxifylline 1200 mg/day and UDCA 13 mg/kg/day.
Duration of treatment: 12 months. All people also underwent lifestyle modification (diet and regular exercise). |
| Outcomes |
None of the outcomes of interest were reported. |
| 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: "Patients were randomly assigned to three groups:" |
| Allocation concealment (selection bias) |
Unclear risk |
Comment: this information was not available. |
| Blinding of participants and personnel (performance bias)
All outcomes |
Unclear risk |
Comment: this information was not available. |
| Blinding of outcome assessment (detection bias)
All outcomes |
Unclear risk |
Comment: this information was not available. |
| 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. |
