Lee 2007.

Study characteristics
Methods	Study design: Historically controlled trial Study grouping: Method: 4‐week dietary washout period; 4‐week before‐and‐after study
Participants	Baseline Characteristics 2 mg n: 110 Age (years): 59.6 Males (n): 35 Females (n): 75 BMI: 25.2 Total cholesterol: 239 mg/dL (6.18 mmol/L) LDL cholesterol: 159 mg/dL (4.11 mmol/L) HDL cholesterol: 52 mg/dL (1.34 mmol/L) Triglycerides: 142 mg/dL (1.60 mmol/L) Included criteria: Korean men and women aged 20 to 79 years who had untreated hypercholesterolaemia Excluded criteria: Pregnant and breastfeeding women were excluded. Other exclusion criteria were current use of lipid‐lowering therapy, uncontrolled diabetes mellitus (fasting plasma glucose concentration > 180 mg/dL), uncontrolled hypertension (diastolic blood pressure > 115 mm Hg), a history of cerebrovascular disease or myocardial infarction within 3 months of enrolment, congestive heart failure, a serum creatinine concentration > 2.0 mg/dL, hepatic dysfunction (transaminase levels > 2.5 times the upper limit of normal [ULN]), or an unexplained serum creatine kinase (CK) elevation > 2.5 times the ULN Baseline Characteristics: The characteristics of the 2 groups were similar at baseline.
Interventions	Intervention Characteristics 2 mg
Outcomes	Total cholesterol Outcome type: Continuous Unit of measure: Percentage change from baseline Direction: Lower is better LDL cholesterol Outcome type: Continuous Unit of measure: Percentage change from baseline Direction: Lower is better HDL cholesterol Outcome type: Continuous Unit of measure: Percentage change from baseline Direction: Higher is better Triglycerides Outcome type: Continuous Unit of measure: Percentage change from baseline Direction: Lower is better
Notes	Nima Alaeiilkhchi on 27/01/2018 11:48 Included We calculated the incomplete outcome data based on best estimates from the results.
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)	Low risk	Judgement Comment: LDL‐cholesterol outcome was reported.
Other bias	High risk	Judgement Comment: Study was funded by Choongwae Pharma Corp. Seoul, Republic of Korea.
Incomplete outcome data (attrition bias) Total cholesterol	High risk	[(136 ‐ 110)/136] X 100 = 19.1% were not included in the efficacy analysis.
Incomplete outcome data (attrition bias) LDL cholesterol)	High risk	[(136 ‐ 110)/136] X 100 = 19.1% were not included in the efficacy analysis.
Incomplete outcome data (attrition bias) HDL cholesterol	High risk	[(136 ‐ 110)/136] X 100 = 19.1% were not included in the efficacy analysis.
Incomplete outcome data (attrition bias) Triglycerides	High risk	[(136 ‐ 110)/136] X 100 = 19.1% were not included in the efficacy analysis.
Blinding of outcome assessment (detection bias)WDAEs	High risk	No comparison possible
Selective reporting (reporting bias) for WDAEs	High risk	No WDAE outcome reported