Ikegami 2012.

Study characteristics
Methods	Study design: Historically controlled trial Study grouping: Method: No participants were receiving lipid medications, therefore, washout period not required; 3‐month before‐and‐after trial
Participants	Baseline Characteristics 2 mg n: 15 Males: 10 Females: 5 Age (years): 43.7 Total cholesterol: 242.8 mg/dL (6.28 mmol/L) Included criteria: 15 men and women with hypercholesterolaemia Excluded criteria: alcohol consumption of more than 20 g per week; evidence of pregnancy, treatment with corticosteroid, and hormone replacement therapy. Subjects using lipid‐lowering medication or food enriched with functional plant stanols or sterols were excluded from the study. Subjects with positive test results for the following disorders were also excluded: secondary causes of steatohepatitis and drug‐induced liver injury, viral hepatitis, autoimmune hepatitis, primary biliary cirrhosis, a‐1‐antitrypsin deficiency, haemochromatosis, Wilson’s disease, and biliary obstruction. Baseline Group Characteristics: The mean ages and ratios of male/female subjects were not significantly different between the control and NAFLD groups.
Interventions	Intervention Characteristics 2 mg
Outcomes	Total cholesterol Outcome type: Continuous Unit of measure: Percentage change from baseline Direction: Lower is better Data value: Change from baseline
Notes	Stephen P on 27/01/2018 11:00 Included Post hoc of Hyogo 2011 trial
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	High risk	Judgement Comment: Controlled before‐and‐after design
Allocation concealment (selection bias)	High risk	Judgement Comment: Controlled before‐and‐after design
Blinding of participants and personnel (performance bias) All outcomes	Low risk	Judgement Comment: Lipid parameter measurements unlikely to be influenced by lack of blinding
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Judgement Comment: Lipid parameters were measured in a remote laboratory.
Selective reporting (reporting bias)	High risk	Judgement Comment: LDL‐C outcome was not reported.
Other bias	Low risk	Judgement Comment: This study was supported by grants from the Ministry of Education, Culture, Sports, Science and Technology of Japan.
Incomplete outcome data (attrition bias) Total cholesterol	Low risk	All participants were included in the efficacy analysis.
Incomplete outcome data (attrition bias) LDL cholesterol)	High risk	LDL cholesterol was not reported.
Incomplete outcome data (attrition bias) HDL cholesterol	High risk	HDL cholesterol was not reported.
Incomplete outcome data (attrition bias) Triglycerides	High risk	Triglycerides were not reported.
Blinding of outcome assessment (detection bias)WDAEs	High risk	No comparison possible
Selective reporting (reporting bias) for WDAEs	High risk	No WDAE outcome reported