Acupuncture and Moxibustion for Hyperlipemia (AMH-RCT)

The First Affiliated Hospital of Hunan University of Traditional Chinese Medicine

Status: Unknown

Conditions: Hyperlipidemias

Treatments: Other: Therapeutic Lifestyle Change; Drug: Simvastatin; Other: acupuncture and moxibustion

Study type: Interventional

Funder types: Other

Identifiers

NCT02269046

LML

Details and patient eligibility

About

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.

Enrollment: 210 estimated patients

Sex: All

Ages: 20 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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210 participants in 3 patient groups

Acupuncture and moxibustion

Experimental group

Description:

* 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.

Treatment:

Other: acupuncture and moxibustion

Other: Therapeutic Lifestyle Change

Simvastatin

Active Comparator group

Description:

* therapeutic lifestyle change * simvastatin * oral administration with 10mg per day * seven days per week for 12 weeks.

Treatment:

Drug: Simvastatin

Other: Therapeutic Lifestyle Change

waiting list

Other group

Description:

- therapeutic lifestyle change

Treatment:

Other: Therapeutic Lifestyle Change