Yan 2015.
| Methods | Randomised clinical trial | |
| Participants | Country: China. Number randomised: 122. Post‐randomisation drop‐outs: not stated. Revised sample size: 122. Average age: 52 years. Females: 62 (50.8%). NASH: not stated. Diabetics: not stated. Average follow‐up period in months: 4. Inclusion criteria 1. Patients with NAFLD and impaired glucose tolerance or diabetes. Exclusion criteria 1. Alcohol consumption ≥ 10 g/day for women and 20 g/day for men. 2. Hepatitis B or C, or other liver diseases. 3. Treatment with the following drugs within 4 weeks before enrolment: hypoglycaemic or lipid‐regulating (statins, fibrates) drugs, silybin, ursodeoxycholic acid, bicyclol, phosphatidylcholine and vitamin E and Chinese herbs. 4. Patients with severe metabolic abnormalities and organ dysfunction. | |
| Interventions | Participants were randomly assigned to two groups. Group 1: pioglitazone (N = 60). Further details: pioglitazone 15 mg once daily. Group 2: control (N = 62). Further details: control: no intervention. Duration of treatment: 4 months. All people also underwent lifestyle modification (diet and regular exercise). | |
| Outcomes | Outcomes reported: 1. Adverse events. | |
| Notes | Another group which received a Chinese herb and Pioglitazone was excluded. Reasons for post‐randomisation drop‐outs: not stated. | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Quote: "computer‐generated random allocation sequence". |
| Allocation concealment (selection bias) | Unclear risk | Comment: this information was not available. |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Quote: "open‐label clinical trial". |
| Blinding of outcome assessment (detection bias) All outcomes | High risk | Quote: "open‐label clinical trial". |
| Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Comment: It was not clear whether all participants were included in the analysis of adverse events. |
| Selective reporting (reporting bias) | High risk | Comment: protocol was not available; mortality was not reported. |
| For‐profit bias | Low risk | Quote: "Funding was by several Government agencies in China". |
| Other bias | Low risk | Comment: no other risk of bias. |
AST = aspartate transaminase
ALT = alanine transaminase
BMI = Body Mass Index
GGT = gamma glutamyl transferase
HBV = hepatitis B virus
HCV = hepatitis C virus
LDL = low density lipoprotein
MRI = magnetic resonance imaging
NAFLD = non‐alcohol related fatty liver disease
NASH = non‐alcohol related steatohepatitis
NYHA = New York Heart Association
TNF = Tumour Necrosis Factor
UDCA = ursodeoxycholic acid
US = ultrasound