Efficacy and Safety of Auricular Acupressure in Treating Allergic Rhinitis

Nasal Congestion Clinical Trial

Official title:

Evaluating Efficacy and Safety of Auricular Acupressure in Treating Allergic Rhinitis: A Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06323304
• Other study ID #: 701/HDDD-DHYD
• Status: Recruiting
• Phase: N/A
• Start date: March 13, 2024
• Est. completion date: June 2024

Study information

• Verified date: April 2024
• Source: University of Medicine and Pharmacy at Ho Chi Minh City
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Allergic rhinitis (AR) is a global health problem affecting approximately 10% to 40% of the population worldwide, with an increasing trend. It significantly impacts health and quality of life. Current treatments for AR include allergen avoidance, symptom-relieving medications, anti-inflammatory therapy, and allergen-specific immunotherapy. However, many patients still experience uncontrolled symptoms despite these approaches, either as monotherapy or in combination, along with medication side effects such as drowsiness, dry eyes, nasal mucosal damage, and immunosuppression. Auricular acupressure therapy (AAT) utilizes ear acupoints by applying pressure with ear seeds. The neurobiological mechanisms of AAT on the human body have gained increasing attention in clinical and experimental studies, involving anti-inflammatory, antioxidant, and immunomodulatory effects. Its efficacy has been recognized, becoming a potential alternative therapy for various conditions such as sleep disorders, obesity, and chronic pain. Previous clinical studies have reported the efficacy and safety of AAT in treating AR. However, the primary outcomes of these studies remain inconsistent and lack specific criteria for evaluating AR treatment efficacy. This study aims to investigate the efficacy and safety of AAT in treating AR based on the ARIA guideline 2019 treatment efficacy criteria. It will provide a basis for applying AAT as a complementary approach in the multimodal treatment of AR.

Description:

Patients with allergic rhinitis who have typical symptoms such as nasal itching, runny nose, sneezing, nasal congestion, and are indicated for corticosteroid nasal spray according to the ARIA 2019 diagnostic and treatment guidelines will be registered for this study. They will then be randomly assigned to two groups: Intervention group (auricular acupressure therapy + fluticasone propionate nasal spray), and control group (sham auricular acupressure therapy + fluticasone propionate nasal spray). The allocation ratio for the two groups is 1:1. The intervention period for both groups is four weeks. Auricular acupressure therapy or sham acupressure therapy will be performed every week. Fluticasone propionate nasal spray will be used whenever symptoms occur. Patients will also be encouraged to adjust their lifestyle and living environment. Data on the severity of allergic rhinitis symptoms (including nasal itching, sneezing, runny nose, nasal congestion, eye symptoms, and headache), the Rhinitis Quality of Life Questionnaire (RQLQ), and side effects of auricular acupressure therapy will be recorded before the study and weekly for 4 weeks.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: June 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• Patients must be diagnosed with allergic rhinitis according to the ARIA 2019 (Allergic Rhinitis and its Impact on Asthma) diagnostic criteria, must be between 18 and 60 years old.
• Must have had typical symptoms of allergic rhinitis for at least 2 years.
• Must provide written informed consent to participate in the study.
• Must be mentally alert and able to communicate effectively.
• Must have vital signs within normal limits (pulse, blood pressure, temperature, respiratory rate, SpO2).
• Must not have any other chronic diseases, including respiratory diseases (asthma, pneumonia, chronic obstructive pulmonary disease, etc.), thyroid disease, autonomic nervous system disorders, hypertension, or diabetes, as determined by medical history.
• Must not have any knowledge of auricular therapy.

Exclusion Criteria:

• Have used decongestants, antihistamines, anticholinergics, or oral corticosteroids within the past 1 week.
• Have undergone auricular acupuncture, auricular acupressure, or other forms of acupuncture for the treatment of other respiratory diseases within the past 6 months.
• Have used stimulants (alcohol, beer, coffee, tobacco) within 24 hours of the study.
• Lesions (scars, tears, scratches, bites) on the left auricle.
• Allergic rhinitis with secondary infection, acute sinusitis or acute exacerbation of chronic sinusitis, or chronic sinusitis.

Related Conditions & MeSH terms

• Itching
• Nasal Congestion
• Rhinitis
• Rhinitis, Allergic
• Sneezing

Intervention

Other:
• Auricular acupressure
Auricular acupressure therapy will be performed once a week for 4 weeks using Vaccaria seeds, which is an herb in traditional medicine. The acupoints on the ear that will be treated with auricular acupressure therapy are Shenmen (TF4), Internal nose (TG4), Lung (CO14), Wind stream (SF1,2i), Adrenal gland (TG2p). These acupoints are believed to be effective in the treatment of allergic rhinitis. The patches will be kept on the auricle for one week.
• Sham acupressure
Sham acupressure therapy will be performed once a week for 4 weeks using Vaccaria seeds. The acupoints that will be treated with auricular acupressure therapy are Helix 2 (HX10), Shoulder (SF4), Clavicle (SF6), Anus (HX5) and Tooth (LO1). These acupoints are not used to treat allergic immune-related problems or respiratory diseases. The patches will be kept on the auricle for one week.
• Standard treatment
Standard treatment, continuously administered over the 4-week intervention period, involves standard doses of fluticasone propionate nasal spray as needed, and lifestyle modifications.

Locations

Country	Name	City	State
Vietnam	University of Medical Center HCMC - Branch no.3	Ho Chi Minh

Sponsors (1)

Lead Sponsor	Collaborator
University of Medicine and Pharmacy at Ho Chi Minh City

Country where clinical trial is conducted

Vietnam, 

References & Publications (10)

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Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The change of nasal and non nasal symptom scores	Symptom scores will be assessed based on a visual analogue scale (VAS). It usually consists of a 100 mm line anchored at each end by descriptors.	Assessments were conducted before intervention and after each intervention week throughout the four weeks (Week 0, Week 1, Week 2, Week 3, Week 4)
Secondary	The change of Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) score	The RQLQ consists of 28 items. Participants will be requested to express their agreement using a Likert-type scale that ranges from 0=not troubled to 6=extremely troubled. The RQLQ score is calculated by taking the sum of the scores for all question. The higher the score, the more impaired the quality of life.	Assessments were conducted before intervention and after each intervention week throughout the four weeks (Week 0, Week 1, Week 2, Week 3, Week 4)
Secondary	The change of relief medication usage	The number of times fluticasone propionate nasal spray is used is recorded each week by asking the patient.	Assessments were conducted after each intervention week throughout the four weeks (Week 1, Week 2, Week 3, Week 4)
Secondary	Proportion of intervention-related adverse events	While auricular acupressure is generally considered safe, some patients may experience minor side effects at the application site. These can include temporary pain, discomfort, itching, redness, or minor inflammation. Rarely, more serious complications like chondritis, dizziness, nausea, or allergic reactions may occur. The study will closely monitor and document any unexpected adverse events associated with the procedure.	Up to four weeks

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