Efficacy, Safety and Underlying Mechanisms of Sphenopalatine Ganglion Acupuncture for Seasonal Allergic Rhinitis

Capital Medical University

Status: Enrolling

Conditions: Seasonal Allergic Rhinitis

Treatments: Procedure: sham acupuncture; Procedure: SPA acupuncture

Study type: Interventional

Funder types: Other

Identifiers

NCT04052945

SPA acupuncture for SAR

Details and patient eligibility

About

In recent years, a number of randomized controlled trials have confirmed the efficacy and safety of acupuncture in the treatment of allergic rhinitis (AR). Indeed, the latest American clinical guidelines recommended acupuncture treatment for AR patients who are interested in non-pharmacological treatment.

In conventional acupuncture treatment for AR, needles are inserted at specific acupoints in the body; with several studies demonstrating acupuncture of sphenopalatine ganglion (SPG) to improve nasal symptoms and quality of life in nasal inflammatory diseases.

The investigators hypothesize that, compared with sham acupuncture and rescue medication (RM), active SPG acupuncture combined with RM would lead to greater improvements in symptoms score and reduction in overall need for antihistamines. To test this hypothesis the investigators design a randomized, double blind, controlled trial to evaluate the efficacy of SPG acupuncture in pollen-induced seasonal AR patients and to explore the potential underlying mechanisms.

Enrollment: 70 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. history of physician-diagnosed SAR with at least 2 years of typical symptoms, and TNSS>=6 at v0.
2. positive skin prick test (SPT) and/or positive serum antigen specific IgE to local seasonal pollens (Giant Ragweed, Mugwort, Goosefoot, etc)

Exclusion criteria

1. oral steroids within 4 weeks prior to recruitment
2. nasal steroids and/or antihistamine 2 weeks prior to recruitment
3. perennial AR
4. any respiratory infection within the previous 4 weeks prior to recruitment
5. history of nasal polyps, asthma or autoimmune disorders
6. previously received acupuncture therapy for AR within 1 month prior to recruitment

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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70 participants in 2 patient groups

SPA acupuncture

Active Comparator group

Description:

active SPG acupuncture plus rescue medication (AA group)

Treatment:

Procedure: SPA acupuncture

sham acupuncture

Sham Comparator group

Description:

sham-SPG acupuncture plus rescue medication (SA group)

Treatment:

Procedure: sham acupuncture