| Methods |
Randomised clinical trial |
| Participants |
Country: United Kingdom.
Number randomised: 74.
Post‐randomisation drop‐outs: 0 (0%).
Revised sample size: 74.
Average age: 54 years.
Females: 29 (39,2%).
NASH: 74 (100%).
Diabetics: 0 (0%).
Average follow‐up period in months: 12.
Inclusion criteria
1. Age 18 to 70 years of age.
2. Biopsy proven NASH.
3. If under lipid lowering treatment, stable dosage in the previous 3 months before the run‐in period.
Exclusion criteria
1. History of alcohol excess more than 210 g per week for men and more than 140 g per week for women.
2. Liver diseases other than NAFLD.
3. Treatment with drugs associated with fatty liver.
4. Diabetes.
5. Only simple steatosis at biopsy.
6. Treatment with weight‐reduction medications.
7. Pregnancy or lactation.
8. Current or previous heart failure.
9. Renal impairment. |
| Interventions |
Participants were randomly assigned to two groups.
Group 1: pioglitazone (N = 37).
Further details: pioglitazone (30 mg/day).
Group 2: control (N = 37).
Further details: control: placebo.
Duration of treatment: 12 months. All people also underwent diet and lifestyle modification. |
| Outcomes |
Outcomes reported: 1. Deaths 2. Adverse events 3. Decompensated liver disease 4. Liver transplantation 5. Cirrhosis. |
| Notes |
Authors provided additional information in February 2016. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Low risk |
Quote: "Randomization was performed via the arand computer program (Pharmacy department, University Hospitals NHS Trust, Nottingham, UK) in blocks of 4 ". |
| Allocation concealment (selection bias) |
Low risk |
Quote: "Randomisation was done in research pharmacy and study nurse provided tablets to the patients. "
Comment: Replies by authors. |
| Blinding of participants and personnel (performance bias)
All outcomes |
Low risk |
Quote: "randomized, double‐blind, placebo controlled trial". |
| Blinding of outcome assessment (detection bias)
All outcomes |
Low risk |
Quote: "randomized, double‐blind, placebo controlled trial". |
| Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
Comment: there were no post‐randomisation drop‐outs. |
| Selective reporting (reporting bias) |
Low risk |
Comment: mortality and adverse events were reported. |
| For‐profit bias |
High risk |
Quote: "Takeda Pharmaceuticals UK provided the pioglitazone and placebo tablets for this investigator‐initiated study". |
| Other bias |
Low risk |
Comment: no other risk of bias. |
