Acupuncture and Moxibustion for Hyperlipemia

NCT02269046 | Unknown DMC

• 1 other identifier: LML
• Study Type: interventional
• Target: 210
• Locations: 1 country
• Sites: 3

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.

Conditions

Hyperlipidemias

Keywords

acupuncture; moxibustion; hyperlipidemias; effectiveness

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 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

Other Outcomes (2)

• Safety

  12 weeks

• Adherence of acupuncture

  12 weeks

Study Arms (3)

Acupuncture and moxibustion

EXPERIMENTAL

* 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; Other: Therapeutic Lifestyle Change

Simvastatin

ACTIVE COMPARATOR

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

Drug: Simvastatin; Other: Therapeutic Lifestyle Change

waiting list

OTHER

\- therapeutic lifestyle change

Other: Therapeutic Lifestyle Change

Interventions

acupuncture and moxibustion OTHER

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)

Acupuncture and moxibustion

Simvastatin DRUG

10mg/d,p.o,12 weeks.

Simvastatin

Therapeutic Lifestyle Change OTHER

* 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

Acupuncture and moxibustion; Simvastatin; waiting list

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• Risk Factor Group: LDL-C ≥160 mg/dL
• + 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%

You may not qualify if:

• 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

Sponsors & Collaborators

• The First Affiliated Hospital of Hunan University of Traditional Chinese Medicine: lead
• University of British Columbia: collaborator
• State Administration of Traditional Chinese Medicine of the People's Republic of China: collaborator

Study Sites (3)

Changsha Hospital of Chinese Medicine

Changsha, Hunan, 410002, China

Location

Second Hospital of Hunan University of Chinese Medicine

Changsha, Hunan, 410005, China

Location

First Hospital of Hunan University of Chinese Medicine

Changsha, Hunan, 410007, China

Location

Related Publications (7)

• 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.

  PMID: 22483185 BACKGROUND

• 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.

  PMID: 16309161 BACKGROUND

• 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.

  PMID: 16136949 BACKGROUND

• 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.

  PMID: 11368702 BACKGROUND

• 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.

  PMID: 24222016 BACKGROUND

• 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.

  PMID: 24924450 BACKGROUND

• 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.

  PMID: 28693531 DERIVED

MeSH Terms

Conditions

Hyperlipidemias

Interventions

Acupuncture Therapy; Moxibustion; Simvastatin

Condition Hierarchy (Ancestors)

Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Lovastatin; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds

Study Officials

• Xiaorong Chang, Prof.

  Hunan University of Chinese Medicine

  STUDY CHAIR

Central Study Contacts

Mailan Liu, Dr.

CONTACT

86-18229792024; 445007305@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 26, 2014
• First Posted: October 20, 2014
• Study Start: December 1, 2014
• Primary Completion: December 1, 2016
• Study Completion: September 1, 2017
• Last Updated: October 20, 2014

Record last verified: 2014-08

Locations

CN (3)