Acupuncture and Moxibustion for Hyperlipemia

Study Overview
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Brief Summary
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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.

Official Title
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A Multi-center, Randomized, Stratified, Active-controlled Trial to Evaluate the Effects of Acupuncture and Moxibustion for Hyperlipidemias

Conditions
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Hyperlipidemias

Intervention / Treatment
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* Other: acupuncture and moxibustion
* Drug: Simvastatin
* Other: Therapeutic Lifestyle Change


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Acupuncture and moxibustion<br>therapeutic lifestyle change Group I:Juque (RN14), Tianshu (ST25, bilateral), Fenglong (ST40, bilateral), Zusanli (ST 36, bilateral), Sanyinjiao (SP6, bilateral) Group II: Pishu (BL20, bilateral), Xinshu (BL15, bilateral), Ganshu (BL18, bilateral), Shenshu (BL23, bilateral) Group I and II will change alternatively every other week . Once per day five days per week. | Other: acupuncture and moxibustion<br>* Warm needling acupuncture on Fenglong (ST40, bilateral), Zusanli (ST36, bilateral), Sanyinjiao (SP6, bilateral) and Cake-seperated moxibustion on Juque (RN14), Tianshu (ST25, bilateral), Pishu (BL20, bilateral), Xinshu (BL15, bilateral), Ganshu (BL18, bilateral), Shenshu (BL23, bilateral)<br>Other: Therapeutic Lifestyle Change<br>* Reduced intakes of saturated fats (<7% of total calories) and cholesterol (<200 mg per day) Therapeutic options for enhancing LDL lowering Weight reduction Increased physical activity<br>|
| Active Comparator: Simvastatin<br>therapeutic lifestyle change simvastatin oral administration with 10mg per day seven days per week for 12 weeks. | Drug: Simvastatin<br>* 10mg/d,p.o,12 weeks.<br>Other: Therapeutic Lifestyle Change<br>* Reduced intakes of saturated fats (<7% of total calories) and cholesterol (<200 mg per day) Therapeutic options for enhancing LDL lowering Weight reduction Increased physical activity<br>|
| Other: waiting list<br>- therapeutic lifestyle change | Other: Therapeutic Lifestyle Change<br>* Reduced intakes of saturated fats (<7% of total calories) and cholesterol (<200 mg per day) Therapeutic options for enhancing LDL lowering Weight reduction Increased physical activity<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| low-density lipoprotein cholesterol (LDL-C) | To evaluate the effect of 12 weeks of acupuncture compared with active control, on percent change from baseline in low-density lipoprotein cholesterol (LDL-C) among those with hyperlipidemia. | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| high-density lipoprotein cholesterol (HDL-C) |  | 12 weeks | 
| total cholesterol (TC) |  | 12 weeks | 
| triglyceride(TG) |  | 12 weeks | 
| the rate of subjects achieving LDL-C goal |  | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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acupuncture, moxibustion, hyperlipidemias, effectiveness