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 abnormal levels of blood lipids and is an important risk factor for cardiovascular disease. Although current management primarily relies on lifestyle modification and lipid-lowering medications, particularly statins, some patients may have an inadequate treatment response, experience adverse effects, or have difficulty maintaining long-term adherence.

Traditional Chinese Medicine therapies are increasingly used as complementary approaches to conventional treatment. Auricular acupuncture, which stimulates specific acupoints on the ear, has been investigated for its potential effects on lipid metabolism. In Traditional Chinese Medicine, Phlegm-Dampness syndrome is considered a common syndrome pattern associated with dyslipidemia. However, clinical evidence regarding the effects of auricular acupuncture on blood lipid parameters and Phlegm-Dampness symptoms in patients with dyslipidemia remains limited, particularly in Vietnam.

This randomized controlled trial evaluates the effects of auricular acupuncture combined with atorvastatin compared with atorvastatin plus sham auricular acupuncture in patients with dyslipidemia presenting with Phlegm-Dampness syndrome. The primary outcome is the change in blood lipid parameters, including total cholesterol (TC), triglycerides (TG), low-density lipoprotein cholesterol (LDL-C), and high-density lipoprotein cholesterol (HDL-C), from baseline to the end of the 8-week intervention. Changes in clinical symptoms of Phlegm-Dampness syndrome are also evaluated.

This single-blind, randomized, sham-controlled clinical trial includes 80 outpatients aged 18 years or older with dyslipidemia presenting with Phlegm-Dampness syndrome at Le Van Thinh Hospital, Ho Chi Minh City, Vietnam. Only participants are blinded to group allocation. Participants are randomly assigned to two equal groups. Both groups receive atorvastatin 20 mg once daily after dinner and are advised to follow a lipid-lowering, high-fiber diet.

The intervention group receives Khanh Phong intradermal auricular needles applied to five auricular acupoints: Pi (CO13), Stomach (CO4), Endocrine (CO18), Sympathetic (AH6a), and Shenmen (TF4). The therapeutic points are selected according to traditional medicine treatment principles for Phlegm-Dampness syndrome and the Vietnamese traditional medicine guideline. Participants are instructed to perform self-acupressure four times daily. The control group receives sham auricular acupuncture performed by inserting the same type of intradermal auricular needles used in the intervention group at three predefined auricular points considered theoretically unrelated to the treatment of dyslipidemia and Phlegm-Dampness syndrome: Finger (SF1), Thoracic Spine (AH11), and Knee (AH4). Participants in the control group are not instructed to perform self-acupressure.

The intervention period lasts 8 weeks. In both groups, intradermal auricular needles are applied at the initial treatment session and subsequently replaced every 5 days, for a total of 12 treatment sessions. In the intervention group, the treated ear is alternated between sessions; in the control group, the needles are applied to the left ear. Participants are monitored for 15 minutes after each procedure and are instructed regarding monitoring for potential adverse events, including fainting, localized pain or swelling, ear bleeding, infection, and perichondritis.

Blood lipid parameters, including total cholesterol (TC), triglycerides (TG), low-density lipoprotein cholesterol (LDL-C), and high-density lipoprotein cholesterol (HDL-C), are measured at baseline (T0) and after the 8-week intervention (T8). The primary outcome is the change in these blood lipid parameters from baseline to T8. Secondary outcomes include the percentage improvement in the nine-symptom Phlegm-Dampness syndrome score, assessed at baseline and every 15 days during the intervention, and the incidence of treatment-emergent adverse events throughout the 8-week study period.

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.