Evaluating Efficacy and Safety of Auricular Acupressure in Treating Allergic Rhinitis: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- The change of nasal and non nasal symptom scores
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Triple-blind method (Participant, Investigator, Outcome assessor) Participants will be blinded to their randomization assignment, either to the intervention group or the control group. Sham acupressure therapy will be performed at acupoints that have no therapeutic effect on allergic rhinitis, and the procedures will be similar to auricular pressure therapy. Both groups will be treated with fluticasone propionate nasal spray, which is the standard treatment.
The physician who perform auricular acupressure therapy or sham acupressure therapy will be aware of the intervention assignment for each group, but they will not be involved in data analysis or outcome assessment. The data analysts and outcome assessors will be blinded to the treatment assignment.
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
The change of nasal and non nasal symptom scores
时间窗: 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.
次要结局
- The change of Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) score(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 change of relief medication usage(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(Up to four weeks)
研究者
Bui Pham Minh Man
Principal Investigator
University of Medicine and Pharmacy at Ho Chi Minh City