| Methods |
Randomised clinical trial |
| Participants |
Country: USA.
Number randomised: 30.
Post‐randomisation drop‐outs: 4 (13.3%).
Revised sample size: 26.
Average age: not stated.
Females: not stated.
NASH: 26 (100%).
Diabetics: not stated.
Average follow‐up period in months: 12.
Inclusion criteria
1. Aged 18 to 65 years.
2. Biopsy proven NASH within 6 months from enrolment.
Exclusion criteria
1. HIV positivity.
2. Ongoing alcohol consumption > 20 g (males) and 10 g (females) daily.
3. Current or past use (in the previous 6 months) of drugs known to cause steatohepatitis (tamoxifen, valproic acid, amiodarone, methotrexate).
4. Current or past history of decompensated liver disease.
5. Renal failure.
6. Evidence of active bleeding.
7. Cerebral or retinal haemorrhage.
8. Concomitant use of thiazolidinediones, weight loss medications, metformin, vitamin E, anti TNF alpha therapy or theophylline.
9. Insulin secretagogues. |
| Interventions |
Participants were randomly assigned to two groups.
Group 1: pentoxifylline (N = 19).
Further details: pentoxifylline 400 mg thrice daily.
Group 2: control (N = 7).
Further details: control: placebo.
Duration of treatment: 12 months. Both groups received dietary and exercise advice. |
| Outcomes |
Outcomes reported: 1. Adverse events. 2. Change in fibrosis score. 3. Change in NAS score. |
| Notes |
Reasons for post‐randomisation drop‐outs: lost to follow‐up, brain tumour, uncovered alcohol abuse. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Low risk |
Quote: "A randomization table was generated to distribute groups in a 2:1 ratio". |
| Allocation concealment (selection bias) |
Low risk |
Quote: "On the morning of the initial visit, subjects were randomized by the Northwestern pharmacy and supplied with corresponding pills PTX or placebo". |
| Blinding of participants and personnel (performance bias)
All outcomes |
Low risk |
Quote: "Investigators and subjects were blinded to the treatment group". |
| Blinding of outcome assessment (detection bias)
All outcomes |
Low risk |
Quote: "Investigators and subjects were blinded to the treatment group". |
| 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 |
Quote: "This research was supported by investigator initiated funds".
Comment: Further information on the source of funding was not available. |
| Other bias |
Low risk |
Comment: no other risk of bias. |
