acupuncture and moxibustion for hyperlipemia

Conditions: Hyperlipidemias

Summary: the purpose of this study is to evaluate the effect of 12 weeks of acupuncture and moxibustion compared with active control, on absolute and percent change from baseline in low-density lipoprotein cholesterol (ldl-c) among those with hyperlipidemia.


Eligibility criteria:
inclusion criteria: * subject signed the informed consent * male or female ≥18 to ≤75 years of age * fasting tg ≤400 mg/dl * fasting ldl-c as determined by central laboratory on admission and meeting the following ldl-c values based on risk factor status: * 0-1 risk factor group: ldl-c ≥160 mg/dl * 2+ risk factor group: ldl-c ≥130 mg/dl * chd or chd risk equivalents: ldl-c ≥100 mg/dl * major risk factors: （1）cigarette smoking;（2）hypertension (bp ≥140/90 mmhg or on anti-hypertensive medication);（3）low hdl cholesterol (hdl-c \<40 mg/dl);（4）family history of premature chd (chd in male first degree relative \<55 years; chd in female first degree relative \<65 years);（5）age (men ≥45 years; women ≥55 years) * chd and chd equivalents:（1）other clinical forms of atherosclerotic disease (peripheral arterial disease, abdominal aortic aneurysm, and symptomatic carotid artery disease);（2）diabetes;（3）multiple risk factors that confer a 10-year risk for chd \>20% exclusion criteria: * chd or chd risk equivalent and not receiving statin therapy, with ldl-c at screening ≤99 mg/dl * nyha ii, iii or iv heart failure, or last known left ventricular ejection fraction \<30% * uncontrolled cardiac arrhythmia, atrial fibrillation with rapid ventricular response, or not controlled supraventricular tachycardia in the past 3 months prior to randomization * myocardial infarction, unstable angina, percutaneous coronary intervention (pci), coronary artery bypass graft (cabg) or stroke within 3 months prior to randomization * planned cardiac surgery or revascularization * type 1 diabetes or newly diagnosed type 2 diabetes or poorly controlled type 2 diabetes * uncontrolled hypertension defined as sitting systolic blood pressure (sbp) \>160 mmhg or diastolic bp (dbp) \>100 mmhg * subjects taken red yeast rice, niacin \>200 mg/d, or omega-3 fatty acids \>1000 mg/d or prescription lipid-regulating drugs other than statins or ezetimibe, such as fibrates and derivatives, or bile-acid sequestering resins in the last 6 weeks prior to ldl-c screening * subjects taken systemic cyclosporine, systemic steroids, vitamin a derivatives and retinol derivatives for the treatment of dermatologic conditions in the last 3 months prior to ldl-c screening * hyperthyroidism or hypothyroidism * moderate to severe renal dysfunction * active liver disease or hepatic dysfunction * ck \>3 times the uln at screening or at end of lipid stabilization period, confirmed by a repeat measurement at least 1 week apart * known active infection or major hematologic, renal, metabolic, gastrointestinal or endocrine dysfunction in the judgment of the investigator * deep vein thrombosis or pulmonary embolism within 3 months prior to randomization * current therapeutic anticoagulation with vitamin k antagonist, heparin, low-molecular weight heparin, direct thrombin inhibitor * currently enrolled in another investigational device or drug study * female subject during pregnant or breast feeding period * history of malignancy (except non-melanoma skin cancers, cervical in-situ carcinoma, breast ductal carcinoma in situ, or stage 1 prostate carcinoma) * known sensitivity to any of the products to be administered during dosing * subjects couldn't provide the written informed consent and/or comply with all required study procedures

Keywords: acupuncture moxibustion hyperlipidemias effectiveness