Evaluation of the Therapeutic Efficacy of Auricular Pellets Combined With Atorvastatin 20mg in Patients With Dyslipidemia and Phlegm-Dampness Syndrome
The Potential Efficacy of Auricular Pellets Combined With Atorvastatin 20mg in Managing Blood Lipid Levels and Improving Phlegm-Dampness Symptoms in 80 Patients With Dyslipidemia and Phlegm-Dampness Syndrome: A Randomized Controlled Trial
Dyslipidemia (DL) is a metabolic disorder characterized by an imbalance of blood lipid components, serving as a leading silent cause of dangerous cardiovascular diseases and increased mortality risk globally. According to the World Health Organization (WHO), cardiovascular diseases account for 32% of all deaths worldwide, with dyslipidemia playing a crucial role in the pathogenesis of 85% of fatalities caused by heart attacks and strokes. Although current management primarily relies on lifestyle modifications and lipid-lowering medications such as statins, fibrates, or niacin, some patients still encounter difficulties due to inadequate treatment response, adverse side effects, or poor long-term compliance. In this context, Traditional Chinese Medicine (TCM) therapies are increasingly being widely applied, either as monotherapy or in combination with Western medicine. Notably, auricular acupuncture-a method focusing on specific acupoints on the ear-has been recognized for its great potential in modulating lipid profiles, particularly demonstrating therapeutic efficacy in patients with Phlegm-Dampness syndrome.
Theoretically and clinically, Phlegm-Dampness syndrome is inextricably linked to the pathogenesis and progression of dyslipidemia (DL); furthermore, clinical research in China indicates that the Phlegm pattern accounts for the highest proportion among the five traditional syndromes of this condition, and a greater severity of Phlegm-Dampness correlates positively with higher levels of TC and LDL-c. In terms of treatment, auricular pellets (a modality of auricular acupuncture) have been demonstrated to improve cardiovascular health by reducing TC, LDL-c, and TGR levels while elevating HDL-c in obese patients with mild-to-moderate DL. In Vietnam, however, studies evaluating the application of auricular pellets in patients with DL remain limited, primarily focusing on individuals with simple overweight or obesity without documented concurrent metabolic disorders. Notably, a study by Nguyen Vu Thien Duyen (2021) reported that a 3-acupoint formula consisting of Hunger (TGR3), Stomach (CO4), and Endocrine (CO18) effectively reduced lipid profiles to a moderate extent in obese individuals.
Given the limitations in evaluating therapeutic efficacy and the scarcity of published studies discussing the effects of lowering blood lipid profiles and alleviating Phlegm-Dampness symptoms for this specific pattern in Vietnam, the investigators conducted this study to evaluate the degree of lipid profile reduction and the clinical symptom improvement of the Phlegm-Dampness syndrome using auricular acupuncture in patients with dyslipidemia presenting with the Phlegm-Dampness syndrome.
연구 개요
상태
상세 설명
- This single-blind, randomized clinical trial is conducted on 80 outpatients aged 18 years or older with simple dyslipidemia presenting with Phlegm-Dampness syndrome at Le Van Thinh Hospital and Ho Chi Minh City Traditional Medicine Hospital. Participants are randomly assigned into two equal groups, both of which maintain a daily regimen of Atorvastatin 20mg (taken after dinner) and adhere to a lipid-lowering, high-fiber diet. The intervention group receives Khanh Phong auricular pellets implemented at 5 specific acupoints, including Spleen (CO11), Stomach (CO4), Endocrine (CO18), Sympathetic (AH6), and Auricular Shenmen (TF4) on the left ear, and is instructed to perform self-acupressure 4 times daily. Meanwhile, the control group undergoes a sham auricular procedure using pellet patches with the needles removed, applied at 3 non-specific technical points, including Finger (SF1), Thoracic Spine (AH11), and Knee (AH4), with absolutely no acupressure performed.
- The intervention period lasts continuously for 8 weeks, with a frequency of replacing the pellets or sham patches once every 5 days on the 6th day, totaling 10 sessions with alternating ears. Patients are strictly monitored for 15 minutes post-procedure and supervised at home to tightly control potential adverse events such as needle fainting, localized pain and swelling, ear bleeding, infection, or perichondritis. The study outcomes are evaluated based on the improvement rate of the total score of 9 clinical symptoms of Phlegm-Dampness syndrome assessed periodically every 15 days, alongside changes in blood lipid profiles (TC, TGR, LDL-c, HDL-c) measured and compared at two distinct time points: pre-intervention (D0) and post-8-week intervention (D60).
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Ngoc Buu To, MD, Master
- 전화번호: +84943382853
- 이메일: tbngoc.ths.yhct24@ump.edu.vn
참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- Diagnosis: Dyslipidemia (DL), untreated or discontinued treatment for at least 1 month, and not taking drugs that induce DL.
- Laboratory Criteria: LDL-c levels between 2.6 and 4.9 mmol/L.
- TCM Criteria:
Diagnosed with Phlegm-Dampness syndrome in patients with DL according to the "Guiding Principles for Clinical Research on Combined Traditional Chinese and Western Medicine":
Primary symptoms: Obesity, heavy sensation in the head, chest tightness, nausea/phlegm expectoration, numbness in limbs.
Secondary symptoms: Palpitations, insomnia, bland taste in the mouth, poor appetite.
Tongue manifestations: Enlarged/flabby tongue, greasy/slippery tongue coating. Pulse: String-taut and slippery pulse (Wiry-Slippery pulse). Diagnostic threshold: Confirmed when presenting >= 50% of TCM Phlegm-Dampness syndrome symptoms in patients with DL.
Exclusion Criteria:
- Participants are non-compliant with the treatment protocol.
- Participants decline to continue study participation for any reason (Withdrawal of consent).
- Participants experience health events during the study and do not wish to continue participation.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: Experimental Group
The intervention group receives Atorvastatin 20mg (1 tablet/day, orally after dinner) combined with a lipid-lowering, high-fiber diet .
Additionally, active auricular pellets are applied once every 5 days at 5 specific acupoints, including Spleen (CO11), Stomach (CO4), Endocrine (CO18), Sympathetic (AH6), and Auricular Shenmen (TF4) on the left ear, with the patches replaced on the 6th day .
Patients are instructed to perform self-acupressure 4 times daily (60 seconds per acupoint) to create stimulation .
The entire procedure totals 10 sessions over an 8-week period, with the diet and exercise regimen maintained throughout the study
|
In this study, active semi-permanent auricular needles (auricular pellets) will be applied to 5 therapeutic acupoints: Spleen (CO11), Stomach (CO4), Endocrine (CO18), Sympathetic (AH6), and Auricular Shenmen (TF4) on the left ear.
Needles will be retained for 5 days to provide continuous stimulation, with the patches replaced on the 6th day.
Participants will be prompted to perform self-acupressure on the points 4 times daily (60 seconds per acupoint).
The entire procedure totals 10 sessions over an 8-week period, performed by a licensed traditional medicine physician following standardized protocols.
다른 이름들:
Participants in both groups are prescribed Atorvastatin 20mg to be taken orally at a dose of 1 tablet per day.
The medication must be administered consistently every day after dinner.
This pharmacological treatment is maintained continuously throughout the 8-week study period to manage and monitor its effects on blood lipid levels.
Participants are instructed to strictly follow a therapeutic lifestyle change regimen throughout the 8-week study period.
The dietary component focuses on a lipid-lowering, high-fiber diet, which includes reducing saturated fat intake, limiting dietary cholesterol to less than 300 mg/day, and increasing the consumption of vegetables and fiber-rich foods.
The exercise component requires participants to maintain a consistent daily physical activity routine tailored to their health status.
Adherence to both diet and exercise guidelines is monitored regularly by the research team.
다른 이름들:
|
|
가짜 비교기: Sham Comparator Group
The control group receives Atorvastatin 20mg (1 tablet/day, orally after dinner) combined with a lipid-lowering and high-fiber diet.
Additionally, sham auricular procedures are administered once every 5 days on the left ear using pellet patches with the needles completely removed.
These sham patches are applied at 3 non-specific technical points, including Finger (SF1), Thoracic Spine (AH11), and Knee (AH4), and patients are strictly instructed NOT to perform any self-acupressure or manual stimulation.
The treatment process consists of a total of 10 sessions over an 8-week period, with the patches replaced on the 6th day of each cycle and alternating ears between sessions.
The dietary and exercise regimen is strictly maintained throughout the study period.
|
Participants in both groups are prescribed Atorvastatin 20mg to be taken orally at a dose of 1 tablet per day.
The medication must be administered consistently every day after dinner.
This pharmacological treatment is maintained continuously throughout the 8-week study period to manage and monitor its effects on blood lipid levels.
Participants are instructed to strictly follow a therapeutic lifestyle change regimen throughout the 8-week study period.
The dietary component focuses on a lipid-lowering, high-fiber diet, which includes reducing saturated fat intake, limiting dietary cholesterol to less than 300 mg/day, and increasing the consumption of vegetables and fiber-rich foods.
The exercise component requires participants to maintain a consistent daily physical activity routine tailored to their health status.
Adherence to both diet and exercise guidelines is monitored regularly by the research team.
다른 이름들:
Sham auricular acupressure will be performed using auricular pellet patches with the needles completely removed, applied to 3 non-therapeutic ear points: Finger (SF1), Thoracic Spine (AH11), and Knee (AH4) on the left ear.
The patches will be replaced on the 6th day, totaling 10 sessions over an 8-week period with alternating ears.
The procedure duration and appearance will be identical to the active intervention to maintain blinding, but participants are strictly instructed NOT to perform any self-acupressure.
다른 이름들:
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Change from baseline in Phlegm-Dampness syndrome clinical symptom score
기간: Baseline, Day 15, Day 30, Day 45, and Day 60 (Week 8)
|
To compare the improvement rate of clinical symptoms of Phlegm-Dampness syndrome between auricular acupressure combined with Atorvastatin and sham auricular acupressure combined with Atorvastatin in dyslipidemia patients every 15 days.
|
Baseline, Day 15, Day 30, Day 45, and Day 60 (Week 8)
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Change from baseline in blood lipid profiles
기간: Baseline and Week 8
|
To compare the changes in blood lipid profiles (including Total Cholesterol [TC], Triglycerides [TG], Low-Density Lipoprotein Cholesterol [LDL-c], and High-Density Lipoprotein Cholesterol [HDL-c]) between auricular acupressure combined with Atorvastatin and sham auricular acupressure combined with Atorvastatin in dyslipidemia patients after 8 weeks.
|
Baseline and Week 8
|
|
Incidence of treatment-emergent adverse events
기간: Throughout the 8-week study period
|
To evaluate the safety of the auricular acupressure procedure by recording adverse events (if any).
|
Throughout the 8-week study period
|
공동 작업자 및 조사자
간행물 및 유용한 링크
일반 간행물
- Chobanian AV, Bakris GL, Black HR, Cushman WC, Green LA, Izzo JL Jr, Jones DW, Materson BJ, Oparil S, Wright JT Jr, Roccella EJ; National Heart, Lung, and Blood Institute Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure; National High Blood Pressure Education Program Coordinating Committee. The Seventh Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure: the JNC 7 report. JAMA. 2003 May 21;289(19):2560-72. doi: 10.1001/jama.289.19.2560. Epub 2003 May 14.
- Writing Group Members; Mozaffarian D, Benjamin EJ, Go AS, Arnett DK, Blaha MJ, Cushman M, Das SR, de Ferranti S, Despres JP, Fullerton HJ, Howard VJ, Huffman MD, Isasi CR, Jimenez MC, Judd SE, Kissela BM, Lichtman JH, Lisabeth LD, Liu S, Mackey RH, Magid DJ, McGuire DK, Mohler ER 3rd, Moy CS, Muntner P, Mussolino ME, Nasir K, Neumar RW, Nichol G, Palaniappan L, Pandey DK, Reeves MJ, Rodriguez CJ, Rosamond W, Sorlie PD, Stein J, Towfighi A, Turan TN, Virani SS, Woo D, Yeh RW, Turner MB; American Heart Association Statistics Committee; Stroke Statistics Subcommittee. Heart Disease and Stroke Statistics-2016 Update: A Report From the American Heart Association. Circulation. 2016 Jan 26;133(4):e38-360. doi: 10.1161/CIR.0000000000000350. Epub 2015 Dec 16. No abstract available.
- Song Q, Yuan Y, Jiao C, Zhu X. Curative effect of Tai Chi exercise in combination with auricular plaster therapy on improving obesity patient with secondary hyperlipidemia. Int J Clin Exp Med. 2015 Nov 15;8(11):21386-92. eCollection 2015.
- Pang T, Liu Z, Xu B. [Clinical observation on obesity and hyperlipidemia of yang deficiency of spleen and kidney syn- drome in female patients treated with warm acupuncture combined with auricular acupuncture]. Zhongguo Zhen Jiu. 2015 Jun;35(6):529-33. Chinese.
- Yeh ML, Chu NF, Hsu MY, Hsu CC, Chung YC. Acupoint Stimulation on Weight Reduction for Obesity: A Randomized Sham-Controlled Study. West J Nurs Res. 2015 Dec;37(12):1517-30. doi: 10.1177/0193945914548707. Epub 2014 Sep 1.
- Cha HS, Park H. Effects of auricular acupressure on obesity in adolescents. Complement Ther Clin Pract. 2019 May;35:316-322. doi: 10.1016/j.ctcp.2019.03.014. Epub 2019 Mar 18.
- Aronow WS. Treatment of high-risk older persons with lipid-lowering drug therapy. Am J Ther. 2008 Mar-Apr;15(2):102-7. doi: 10.1097/MJT.0b013e31802b5aa4.
- Zhang T, Chen J, Tang X, Luo Q, Xu D, Yu B. Interaction between adipocytes and high-density lipoprotein:new insights into the mechanism of obesity-induced dyslipidemia and atherosclerosis. Lipids Health Dis. 2019 Dec 16;18(1):223. doi: 10.1186/s12944-019-1170-9.
- Wang K, Liu Z, Xu B. [Impact on the lipid level of obesity of spleen deficiency and damp blockage complicated by hyperlipemia treated with warm needling therapy and auricular acupuncture]. Zhongguo Zhen Jiu. 2016 Mar;36(3):225-30. Chinese.
- Ismail LA, Ibrahim AA, Abdel-Latif GA, El-Haleem DA, Helmy G, Labib LM, El-Masry MK. Effect of Acupuncture on Body Weight Reduction and Inflammatory Mediators in Egyptian Obese Patients. Open Access Maced J Med Sci. 2015 Mar 15;3(1):85-90. doi: 10.3889/oamjms.2015.010. Epub 2015 Jan 14.
- Liu X, Chen K, Chen F. Clinical efficacy and safety of acupuncture combined with statin in dyslipidemia: A meta-analysis and system review. Medicine (Baltimore). 2024 Sep 13;103(37):e39663. doi: 10.1097/MD.0000000000039663.
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- 496/HDDD-DHYD
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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