Acupuncture for Nasal Congestion in Allergic Rhinitis

Study Overview
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Brief Summary
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Allergic rhinitis (AR) is a disorder that affects more than 500 million people worldwide. Nasal congestion is one of the most general and bothersome symptoms in rhinitis, which affects the quality of life (QOL). Current medications are undesirable due to their side-effects. Acupuncture for AR in general can be considered as safe and can be seen as a potential remedial blueprint for nasal congestion. Evidence supported that acupuncture is clinically used for signs and symptoms of nose disorders, such as nasal congestion, with effectiveness, but whether acupuncture has immediate, post-treatment and long-term effects on nasal congestion in AR is not verified by strictly designed clinical study. The ANCAR trial uses a standard treatment protocol with a fixed set of acupuncture points - to be as scientific as possible from Western medical viewpoint - to open the nose and affect underlying energetic imbalance and immunity at the same time, to maintain its nose opening effect. This novel acupuncture treatment protocol can be seen as a solid and profound approach from which every AR patient may benefit.

Detailed Description
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Worldwide more than approximately 500 million people suffer from AR (30% of the Dutch population) and its prevalence is expanding. Nasal congestion (i.e. reversible mucosal congestion/nasal mucosal obstruction) is one of the most general and bothersome symptoms in rhinitis and is associated with other medical conditions such as rhinosinusitis and otitis media. This study is relevant as in addition to the high global occurrence of AR, this disorder has substantial effects on the quality of life (QOL) (e.g. during sleep and work). AR is related to high direct medical costs (mainly prescription of medications and outpatient visits) and indirect economic costs (including productivity decrease). Current medications are undesirable due to their side-effects (such as sedation in the case of intranasal antihistamines (INAH)). Acupuncture for AR in general can be considered as safe and can be seen as a potential remedial blueprint for nasal congestion. Evidence supported that acupuncture is clinically used for signs and symptoms of nose disorders, such as nasal congestion, with effectiveness, but whether acupuncture has immediate, post-treatment and long-term effects on specifically nasal congestion in AR is not verified by strictly designed clinical study. The ANCAR trial aims to evaluate the effects of an acupuncture treatment protocol for nasal congestion in AR compare to azelastine nasal spray (Carelastin®). A standard treatment protocol with a fixed set of acupuncture points has been established - to be as scientific as possible from Western medical viewpoint - and this selection of acupuncture points can be seen as a solid and profound approach from which every AR patient may benefit. This standard set opens the nose and affects the underlying energetic imbalance and immunity at the same time to maintain its nose opening effect (i.e. to prevent recurrence of the complaint). The acupuncture protocol concerns 8 treatments during 6 weeks (i.e. 2 treatments per week during the first 2 weeks and 1 treatment per week in the consecutive 4 weeks). The positive effects of this treatment protocol (such as improvement QOL) may result in more confidence in the direct, post-treatment and long-term effects of acupuncture and lead to more acceptance of acupuncture as a solid treatment option for nasal congestion in AR instead of using an INAH spray. Hypothesis: Acupuncture will improve nasal congestion in AR compare to azelastine nasal spray (Carelastin®). Objective: To evaluate the effects of an acupuncture treatment protocol for nasal congestion in AR.

Official Title
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Acupuncture for Nasal Congestion in Allergic Rhinitis: An Open-Label, Randomized, Monocenter Trial (ANCAR Trial)

Conditions
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Allergic Rhinitis

Intervention / Treatment
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* Other: Acupuncture
* Drug: Antihistamine nasal spray


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosed AR by a physician Have one of the AR types: seasonal (SAR) or perennial (PAR) or mixed (MAR) allergic rhinitis VAS nasal congestion: 3-10 Age: from 18 years Signed Informed Consent Exclusion Criteria: COVID-19 Acute common cold Influenza Fever (38°C or higher) Acute nasal trauma (such as a fracture and epistaxis) Irreversible nasal blockages (such as septum deviation, concha bullosa, polyps and cysts) Nasal and sinus cancer Pregnancy or planning for pregnancy Consumed decongestions, antihistamines, antibiotics or corticosteroids within 2 weeks before the RCT Received acupuncture, Chinese herbal medicine or another complementary treatment within 2 weeks before the RCT Received immunotherapy within 2 weeks before the RCT Participants refusing or unable to sign Informed Consent

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Open-Label, Randomized, Controlled, Interventional, Monocenter Trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Acupuncture arm<br>Fixed set of acupuncture points | Other: Acupuncture<br>* Fixed set of acupuncture points<br>|
| Active Comparator: Control (Carelastin®) arm<br>Carelastin® (1 mg/ml) azelastine nasal spray, 1 spray puff (0.14 ml) per nostril twice daily (totally 0.56 ml per day) | Drug: Antihistamine nasal spray<br>* Carelastin® (1 mg/ml) azelastine nasal spray<br>* Other names: Intranasal antihistamine (INAH) therapy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Analog Scale (VAS) | To compare the effects of acupuncture and azelastine nasal spray (Carelastin®) on nasal congestion in AR after 6 weeks of treatments based on VAS score. VAS, 0 = no nasal congestion, and 10 = most severe nasal congestion. | After 6 weeks (visit 8). | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Analog Scale (VAS) | To compare the effects of acupuncture and azelastine nasal spray (Carelastin®) on nasal congestion in AR after different visits of treatments based on VAS score. VAS, 0 = no nasal congestion, and 10 = most severe nasal congestion. | At 1st day (visit 1), During 6 weeks of treatments (visit 2-7: Only acupuncture arm), 2 weeks after treatment protocol (visit 9), and 2 months after treatment protocol (visit 10). | 
| Peak Nasal Inspiratory Flow (PNIF) | To compare the effects of acupuncture and azelastine nasal spray (Carelastin®) on nasal congestion in AR after different visits of treatments based on PNIF score (score ranges between 30-370 L/min). | At 1st day (visit 1), After 6 weeks (visit 8), 2 weeks after treatment protocol (visit 9), and 2 months after treatment protocol (visit 10). | 
| Adapted Nasal Obstruction Symptom Evaluation (NOSE) | To compare the effects of acupuncture and azelastine nasal spray (Carelastin®) on nasal congestion in AR after different visits of treatments based on Adapted NOSE score. NOSE, 0 = no problem, and 4 = severe problem. | After 6 weeks (visit 8), and 2 months after treatment protocol (visit 10). | 
| Visual Analog Scale (VAS) | To assess the effects of acupuncture on other nasal and ocular signs and symptoms in AR based on VAS score. VAS, 0 = no symptom, and 10 = most severe symptom. | At 1st day (visit 1), During 6 weeks of treatments (visit 2-7: Only acupuncture arm), After 6 weeks (visit 8), 2 weeks after treatment protocol (visit 9), and 2 months after treatment protocol (visit 10). | 
| Adapted Nasal Obstruction Symptom Evaluation (NOSE) | To assess the effects of acupuncture on general health, concentration and energy level in AR after different visits of treatments based on Adapted NOSE score. NOSE, 0 = excellent, and 4 = poor. | After 6 weeks (visit 8), and 2 months after treatment protocol (visit 10). | 
| Adapted Nasal Obstruction Symptom Evaluation (NOSE) | To assess the effects of acupuncture on equalization of middle ear pressure in AR in the case patients fly and/or dive after different visits of treatments based on adapted NOSE score. NOSE, 0 = no problem, 4 = severe problem, and 99 = not applicable. | After 6 weeks (visit 8), and 2 months after treatment protocol (visit 10). | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acupuncture, Nasal Congestion, Allergic Rhinitis, Randomized