Efficacy and Safety of Auricular Acupressure in Treating Allergic Rhinitis

October 27, 2024 updated by: Bui Pham Minh Man, University of Medicine and Pharmacy at Ho Chi Minh City

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

90

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Vietnam
      • Ho Chi Minh, Vietnam, 700000
        • University of Medical Center HCMC - Branch no.3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Auricular acupressure + fluticasone propionate nasal spray
Auricular acupressure therapy (AAT) once a week on the left ear for a total of four weeks (4 sessions). Fluticasone propionate nasal spray will be used whenever symptoms occur.
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.
Other: 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.
Sham Comparator: Sham acupressure + fluticasone propionate nasal spray
Sham acupressure therapy (SAT) once a week on the left ear for a total of four weeks (4 sessions). Fluticasone propionate nasal spray will be used whenever symptoms occur.
Other: 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.
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The change of nasal and non nasal symptom scores
Time Frame: Assessments were conducted before intervention and after each intervention week throughout the four weeks (Week 0, Week 1, Week 2, Week 3, Week 4)
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
The change of relief medication usage
Time Frame: Assessments were conducted after each intervention week throughout the four weeks (Week 1, Week 2, Week 3, Week 4)
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)
Proportion of intervention-related adverse events
Time Frame: Up to four weeks
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
The change of Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) score
Time Frame: Assessments were conducted before intervention and after each intervention week throughout the four weeks (Week 0, Week 1, Week 2, Week 3, Week 4)
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Medicine and Pharmacy at Ho Chi Minh City

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 13, 2024

Primary Completion (Actual)

August 30, 2024

Study Completion (Actual)

August 30, 2024

Study Registration Dates

First Submitted

March 14, 2024

First Submitted That Met QC Criteria

March 14, 2024

First Posted (Actual)

March 21, 2024

Study Record Updates

Last Update Posted (Actual)

October 29, 2024

Last Update Submitted That Met QC Criteria

October 27, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 701/HDDD-DHYD

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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