Clinical trial NCT02269046: Acupuncture and Moxibustion for Hyperlipemia
Official title: A Multi-center, Randomized, Stratified, Active-controlled Trial to Evaluate the Effects of Acupuncture and Moxibustion for Hyperlipidemias
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hyperlipidemias
Keywords: acupuncture
moxibustion
hyperlipidemias
effectiveness
Lead sponsor: The First Affiliated Hospital of Hunan University of Traditional Chinese Medicine
Sponsor class: OTHER
Collaborators: name: University of British Columbia
name: State Administration of Traditional Chinese Medicine of the People's Republic of China
First posted: 2014-10-20
Enrollment: 210
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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

Primary outcomes:
measure: low-density lipoprotein cholesterol (LDL-C)
timeFrame: 12 weeks
Secondary outcomes:
measure: high-density lipoprotein cholesterol (HDL-C)
timeFrame: 12 weeks
measure: total cholesterol (TC)
timeFrame: 12 weeks
measure: triglyceride(TG)
timeFrame: 12 weeks
measure: the rate of subjects achieving LDL-C goal
timeFrame: 12 weeks
Other outcomes:
measure: Safety
timeFrame: 12 weeks
measure: Adherence of acupuncture
timeFrame: 12 weeks
Locations:
city: Changsha
country: China
facility: Changsha Hospital of Chinese Medicine
state: Hunan
city: Changsha
country: China
facility: Second Hospital of Hunan University of Chinese Medicine
state: Hunan
city: Changsha
country: China
facility: First Hospital of Hunan University of Chinese Medicine
state: Hunan
Study officials:
affiliation: Hunan University of Chinese Medicine
name: Xiaorong Chang, Prof.
role: STUDY_CHAIR
References:
citation: Yue ZH, He XQ, Chang XR, Yuan JL, Yu BS, Liu M, Fu L, Zhang L, Shang LC. The effect of herb-partition moxibustion on Toll-like receptor 4 in rabbit aorta during atherosclerosis. J Acupunct Meridian Stud. 2012 Apr;5(2):72-9. doi: 10.1016/j.jams.2012.01.005. Epub 2012 Feb 10.
citation: Yue ZH, Yan J, Chang XR, Lin YP, Yi SX, Cao XP, Shen J. [Effects of cake-separated moxibustion on ultrastructures of endothelial cells of aorta in the rabbit of hyperlipemia]. Zhongguo Zhen Jiu. 2005 Jan;25(1):64-7. Chinese.
citation: Xiaorong C, Jie Y, Zenghui Y, Jing S, Yaping L, Shouxiang Y, Xiangping C. Effects of medicinal cake-separated moxibustion on plasma 6-keto-PGF1alpha and TXB2 contents in the rabbit of hyperlipemia. J Tradit Chin Med. 2005 Jun;25(2):145-7.
citation: Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults. Executive Summary of The Third Report of The National Cholesterol Education Program (NCEP) Expert Panel on Detection, Evaluation, And Treatment of High Blood Cholesterol In Adults (Adult Treatment Panel III). JAMA. 2001 May 16;285(19):2486-97. doi: 10.1001/jama.285.19.2486. No abstract available.
citation: Stone NJ, Robinson JG, Lichtenstein AH, Bairey Merz CN, Blum CB, Eckel RH, Goldberg AC, Gordon D, Levy D, Lloyd-Jones DM, McBride P, Schwartz JS, Shero ST, Smith SC Jr, Watson K, Wilson PW, Eddleman KM, Jarrett NM, LaBresh K, Nevo L, Wnek J, Anderson JL, Halperin JL, Albert NM, Bozkurt B, Brindis RG, Curtis LH, DeMets D, Hochman JS, Kovacs RJ, Ohman EM, Pressler SJ, Sellke FW, Shen WK, Smith SC Jr, Tomaselli GF; American College of Cardiology/American Heart Association Task Force on Practice Guidelines. 2013 ACC/AHA guideline on the treatment of blood cholesterol to reduce atherosclerotic cardiovascular risk in adults: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. Circulation. 2014 Jun 24;129(25 Suppl 2):S1-45. doi: 10.1161/01.cir.0000437738.63853.7a. Epub 2013 Nov 12. No abstract available.
citation: Yan X, Chen H, Gao W, Li J, Yang X, Ye P, Zhang S, Zhao D, Zhu J, Huo Y. [Consensus standpoints from expert panel of Chinese Society of Cardiology on AHA/ACC 2013 guideline on the treatment of blood cholesterol to reduce atherosclerotic cardiovascular risk in adults]. Zhonghua Xin Xue Guan Bing Za Zhi. 2014 Apr;42(4):275-6. No abstract available. Chinese.
citation: Liu M, Zhang Q, Jiang S, Liu M, Zhang G, Yue Z, Chen Q, Zhou J, Zou Y, Li D, Ma M, Dai G, Zhong H, Wang Z, Chang X. Warm-needling acupuncture and medicinal cake-separated moxibustion for hyperlipidemia: study protocol for a randomized controlled trial. Trials. 2017 Jul 10;18(1):310. doi: 10.1186/s13063-017-2029-x.