Park 2005.

Study characteristics
Methods	Study design: Historically controlled trial Study grouping: Method: 4‐week washout dietary lead‐in period; 8‐week before‐and‐after study
Participants	Baseline Characteristics 2 mg n: 49 Age (years): 59.9 Males (n): 18 Females (n): 31 BMI: 24.9 Total cholesterol: 246.8 mg/dL (6.38 mmol/L) LDL cholesterol: 170.0 mg/dL (4.40 mmol/L) HDL cholesterol: 51.0 mg/dL (1.32 mmol/L) Triglycerides: 168.1 mg/dL (1.90 mmol/L) Included criteria: Korean men and women who were aged between 20 and 75 years with fasting triglyceride levels 600 mg/dL and LDL cholesterol levels > 130 mg/dL. The dietary guidelines recommended by the Guideline Committee for Hyperlipidemia Management in Korea were used for the lead‐in period, and the patients continued the diet after randomisation. These recommendations were defined as a diet comprising ≤ 20% of total calories from fat, ≤ 6% of total calories from saturated fat, and a daily cholesterol intake of 200 mg/dL. Excluded criteria: participation in other studies 3 months before enrolment; currently taking any kind of antihyperlipidaemic drug; suffering from uncontrolled diabetes (fasting plasma glucose, ≥ 180 mg/dL), thyroid dysfunction (abnormal thyroid‐stimulating hormone values 0.035 lalU/mL or > 3.1 plU/mL), or uncontrolled hypertension (diastolic blood pressure, > 115 mm Hg); symptomatic cerebrovascular disease or myocardial infarction within 3 months of enrolment; creatine kinase (CK) levels > 2 times the upper limit of normal (ULN); aspartate or alanine aminotransferase levels > 2.5 times ULN; and serum creatinine levels > 2.5 times ULN. Pregnant or breastfeeding women. Baseline Group Characteristics: No significant between‐group differences were found for baseline total cholesterol (P = 0.316), triglyceride (P = 0.278), LDL cholesterol (P = 0.403), or HDL cholesterol (P = 0.615) levels between groups.
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 Direction: Higher is better Triglycerides Outcome type: Continuous Unit of measure: Percentage change from baseline Direction: Lower is better
Notes	Stephen P on 30/06/2018 10:40 Included Only subjects with triglycerides greater than or equal to 150 mg/dL were included in the efficacy analysis (bias reporting).
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: This study was sponsored by Choongwae Pharma Corporation, Seoul, South Korea.
Incomplete outcome data (attrition bias) Total cholesterol	Low risk	[(52 ‐ 49)/52)]*100 = 5.8% participants were not included in the efficacy analysis.
Incomplete outcome data (attrition bias) LDL cholesterol)	Low risk	[(52 ‐ 49)/52)]*100 = 5.8% participants were not included in the efficacy analysis.
Incomplete outcome data (attrition bias) HDL cholesterol	Low risk	[(52 ‐ 49)/52)]*100 = 5.8% participants were not included in the efficacy analysis.
Incomplete outcome data (attrition bias) Triglycerides	High risk	[(52 ‐ 28)/52]*100 = 46.2% participants 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