Phlegm-Dampness Syndrome
Conditions
Brief summary
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.
Detailed description
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.
Interventions
PROCEDUREAuricular Acupressure
In this study, active semi-permanent auricular needles (auricular pellets) will be applied to 5 therapeutic acupoints: Spleen (CO13), 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 12 sessions over an 8-week period, performed by a licensed traditional medicine physician following standardized protocols.
PROCEDURESham 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.
DRUGAtorvastatin
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.
BEHAVIORALDiet 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
University of Medicine and Pharmacy at Ho Chi Minh City
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
Single
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change From Baseline in Total Cholesterol at Week 8 | Baseline and Week 8 | Serum total cholesterol (TC) is measured in mg/dL at baseline and at Week 8. Change from baseline is calculated as the Week 8 value minus the baseline value (Week 8 - baseline). A negative change indicates a reduction in serum total cholesterol concentration. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage Improvement in Phlegm-Dampness Syndrome Clinical Symptom Score | Baseline, Day 15, Day 30, Day 45, and Day 60 (Week 8) | Phlegm-Dampness syndrome clinical symptoms are assessed using a 9-item symptom score based on the Guidelines for Clinical Research on New Chinese Medicine Drugs (Zhongyao Xinyao Linchuang Yanjiu Zhidao Yuanze, 2002), published by the Ministry of Health of the People's Republic of China. The scale assesses nine symptoms: obesity/overweight, heavy sensation in the head, chest tightness, nausea/expectoration of phlegm, numbness of the limbs, palpitations, bland taste in the mouth, reduced appetite, and insomnia. Each item is scored from 0 (absent) to 3 (severe), resulting in a total score ranging from 0 to 27. Higher total scores indicate greater symptom severity and therefore a worse outcome; lower total scores indicate less severe symptoms and therefore a better outcome. The percentage improvement is calculated based on the reduction in the total symptom score from baseline at each assessment time point. |
| Incidence of treatment-emergent adverse events | Throughout the 8-week study period | To evaluate the safety of the auricular acupressure procedure by recording adverse events (if any). |
Countries
Vietnam
Outcome results
None listed