| Methods |
Randomised clinical trial |
| Participants |
Country: India.
Number randomised: 60.
Post‐randomisation drop‐outs: 1 (1.7%).
Revised sample size: 59.
Average age: 39 years.
Females: 24 (40.7%).
NASH: 59 (100%).
Diabetics: not stated.
Average follow‐up period in months: 6.
Inclusion criteria
1. Aged 18 to 70 years.
2. ALT > 1.2 time the upper limit of normal on three occasions at least 1 month apart in the last 6 months.
3. Ultrasound proven fatty liver.
4. Liver biopsy showing steatosis, necro‐inflammation activity, ballooning and/or fibrosis.
Exclusion criteria
1. Alcohol intake > 20 g/day.
2. Viral or auto‐immune hepatitis.
3. Primary biliary cirrhosis.
4. Wilson's disease.
5. Haemochromatosis.
6. Biliary obstruction.
7. Decompensated cirrhosis.
8. Drugs ingestion for > 4 weeks during past 6 months (amiodarone, methotrexate, perhexiline, glucocorticoids, estrogens, tamoxifen, nifedipine, diltiazem).
9. Pregnancy.
10. Insulin treated diabetes. |
| Interventions |
Participants were randomly assigned to two groups.
Group 1: pentoxifylline (N = 30).
Further details: pentoxifylline 400 mg thrice daily.
Group 2: pioglitazone (N = 29).
Further details: pioglitazone 30 mg once daily.
Duration of treatment: 6 months. Both groups received hypocaloric diet and exercise advice. |
| Outcomes |
Outcomes reported: 1. Adverse events. 2. Fibrosis score. |
| Notes |
Reasons for post‐randomisation drop‐outs: lost to follow‐up. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Low risk |
Quote: "Randomization was performed by computer program". |
| Allocation concealment (selection bias) |
Low risk |
Quote: "Randomization was performed by computer program". |
| Blinding of participants and personnel (performance bias)
All outcomes |
High risk |
Quote: "open label randomized controlled trial". |
| Blinding of outcome assessment (detection bias)
All outcomes |
High risk |
Quote: "open label randomized controlled trial".
Comment: Low for histological assessment as the histologist was blind to the treatment groups. |
| 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 |
Unclear risk |
Comment: this information was not available. |
| Other bias |
Low risk |
Comment: no other risk of bias. |
