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. 2020 Jun 19;2020(6):CD012735. doi: 10.1002/14651858.CD012735.pub2

Chen 2015.

Study characteristics
Methods Study design: Historically controlled trial
Study grouping:
Methods: Washout period of 1 month;
3 months before‐and‐after trial
Participants Baseline Characteristics
2 mg
  • n: 34

  • Age (years): 58.2

  • Males (n): 20

  • Females (n): 14

  • Total cholesterol: 6.38 mmol/L (247 mg/dL)

  • LDL cholesterol: 4.40 mmol/L (166 mg/dL)

  • HDL cholesterol: 0.97 mmol/L (37.5 mg/dL)

  • Triglycerides: 2.66 mmol/L (236 mg/dL)

  • Included criteria: primary hyperlipidaemia, fasting levels of 5.72 mmol/L ≤ total cholesterol (TC) ≤ 12.7 mmol/L, 3.64 mmol/L ≤ LDL‐C ≤ 6.50 mmol/L, and TG < 4.52 mmol/L

  • Excluded criteria: secondary hyperlipidaemia; acute coronary syndrome within 6 months, cerebrovascular accident, history of severe trauma or a history of major surgery; severe liver and kidney disease, alanine aminotransferase (ALT), aspartate aminotransferase (AST) exceeds the upper limit of normal value by 3 times, serum creatinine (Cr), urea nitrogen (BUN) more than twice the upper limit of normal; suffering from other serious disease (such as cancer, heart failure, respiratory failure, etc.); abnormal thyroid function; systolic blood pressure ≥ 180 mmHg after drug treatment for severe hypertension or diastolic blood pressure ≥ 110 mmHg; diabetes patients treated by drugs, fasting blood glucose after treatment ≥ 11.1mmol/L; drugs that may affect blood lipid metabolism (such as heparin, amiodarone, contraceptives, etc.); pregnancy, women who are breastfeeding, or women who are planning to become pregnant; those with muscle disease or unexplained serum creatine kinase of more than three times the upper limit of normal; history of allergies or serious adverse reactions to statins; mental disorders or participants who are uncooperative

  • Baseline Group Characteristics: The treatment groups were well matched in terms of age, gender, and disease diagnosis

Interventions Intervention Characteristics
2 mg
Outcomes Total cholesterol
  • Outcome type: Continuous


LDL cholesterol
  • Outcome type: Continuous


HDL cholesterol
  • Outcome type: Continuous


Triglycerides
  • Outcome type: Continuous

Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) High risk Controlled before‐and‐after design
Allocation concealment (selection bias) High risk Controlled before‐and‐after design
Blinding of participants and personnel (performance bias)
All outcomes Low risk Lipid parameter measurements unlikely to be influenced by lack of blinding
Blinding of outcome assessment (detection bias)
All outcomes Low risk Lipid parameters were measured in a remote laboratory.
Selective reporting (reporting bias) Low risk LDL‐cholesterol outcome was reported.
Other bias Unclear risk Source of funding not reported
Incomplete outcome data (attrition bias) Total cholesterol Low risk All participants were included in the efficacy analysis.
Incomplete outcome data (attrition bias) LDL cholesterol) Low risk All participants were included in the efficacy analysis.
Incomplete outcome data (attrition bias) HDL cholesterol Low risk All participants were included in the efficacy analysis.
Incomplete outcome data (attrition bias) Triglycerides Low risk All participants were 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