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

Summary

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.

Conditions

• Phlegm-Dampness Syndrome

Interventions

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 self-acupressure.

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 over an 8-week period, performed by a licensed traditional medicine physician following standardized protocols.

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. Adherence to both diet and exercise guidelines is monitored regularly by the research team.

Sponsors & Collaborators

• University of Medicine and Pharmacy at Ho Chi Minh City

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-05-15

Primary Completion

2026-10-31

Completion

2026-10-31