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.

• 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).

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.

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