Evaluation of the Therapeutic Efficacy of Auricular Pellets Combined With Atorvastatin 20mg in Patients With Dyslipidemia and Phlegm-Dampness Syndrome

Official title

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

Overview

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.

Detailed description

* 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).

Interventions

• Procedure Auricular Acupressure
  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 ove
• Procedure Sham Auricular Acupressure
  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 s
• Drug Atorvastatin
  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.
• Behavioral Diet and exercise regimen
  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. Adherenc

Primary outcome measures

• Change from baseline in Phlegm-Dampness syndrome clinical symptom score [Time frame: Baseline, Day 15, Day 30, Day 45, and Day 60 (Week 8)]

Secondary outcome measures (2)

• Change from baseline in blood lipid profiles [Time frame: Baseline and Week 8]
• Incidence of treatment-emergent adverse events [Time frame: Throughout the 8-week study period]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Publications

• 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 Pre PMID 12748199
• 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, PMID 26673558
• 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. PMID 26885081
• 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. PMID 26480544
• 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. PMID 25183702
• 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. PMID 31003676
• 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. PMID 18356628
• 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. PMID 31842884

Identifiers

NCT: NCT07624604 · 496/HDDD-DHYD

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗