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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-12-01

Study Completion Date

2022-09-30

Brief Summary

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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 perennial AR patients (allergic to indoor allergens, including house dust mite, fungi, animal dander and so one) and to explore the potential underlying mechanisms.

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Detailed Description

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Conditions

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Perennial Allergic Rhinitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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SPA acupuncture

active SPG acupuncture plus rescue medication (AA group)

Group Type ACTIVE_COMPARATOR

SPA acupuncture

Intervention Type PROCEDURE

For patients in the AA group, acupuncture was performed at a selected point in the SPG by inserting the needle from the lower border of the zygomatic arch, posterior to the suture protuberance between the zygomatic process and temporal process. The needle was directed obliquely anteriorly, until nearly the whole needle was beneath the skin, and then rotated until the patient felt "de-qi" sensations . The patients in the AA group received four courses of active acupuncture(visit 1,2,3 and 4), twice a week during weeks 1 and 2, and then followed-up for a further 2 weeks (visit 5 during week 3 and visit 6 during week 4).

sham acupuncture

sham-SPG acupuncture plus rescue medication (SA group)

Group Type SHAM_COMPARATOR

sham acupuncture

Intervention Type PROCEDURE

For patients in the SA group, the needle was inserted at the same acupuncture point as for patients in the AA group, but to a depth of only 2-3cm and the procedure of rotating, twirling and thrusting the needle was repeated. During the acupuncture process, the acupuncturist sat on the side of the participant, where the patient could neither see the acupuncturist's face nor the length of the needle. The patients in the SA group received four courses of active acupuncture(visit 1,2,3 and 4), twice a week during weeks 1 and 2, and then followed-up for a further 2 weeks (visit 5 during week 3 and visit 6 during week 4).

Interventions

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SPA acupuncture

For patients in the AA group, acupuncture was performed at a selected point in the SPG by inserting the needle from the lower border of the zygomatic arch, posterior to the suture protuberance between the zygomatic process and temporal process. The needle was directed obliquely anteriorly, until nearly the whole needle was beneath the skin, and then rotated until the patient felt "de-qi" sensations . The patients in the AA group received four courses of active acupuncture(visit 1,2,3 and 4), twice a week during weeks 1 and 2, and then followed-up for a further 2 weeks (visit 5 during week 3 and visit 6 during week 4).

Intervention Type PROCEDURE

sham acupuncture

For patients in the SA group, the needle was inserted at the same acupuncture point as for patients in the AA group, but to a depth of only 2-3cm and the procedure of rotating, twirling and thrusting the needle was repeated. During the acupuncture process, the acupuncturist sat on the side of the participant, where the patient could neither see the acupuncturist's face nor the length of the needle. The patients in the SA group received four courses of active acupuncture(visit 1,2,3 and 4), twice a week during weeks 1 and 2, and then followed-up for a further 2 weeks (visit 5 during week 3 and visit 6 during week 4).

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* 1\. history of physician-diagnosed PAR with at least 2 years of typical symptoms
* 2\. course on each onset lasting at least 4 weeks
* 3\. skin prick test and/or serum antigen specific IgE positive to indoor allergens(sIgE≥0.7kU/L,≥class 2)
* 4\. good patient compliance on acupuncture treatment
* 5\. total nasal symptom scores(TNSS)\>6 at V0

Exclusion Criteria

* 1\. oral steroids within 4 weeks prior to recruitment
* 2\. nasal steroids and/or antihistamine 2 weeks prior to recruitment
* 3\. seasonal AR
* 4\. any respiratory infection within the previous 4 weeks prior to recruitment
* 5\. history of nasal polyps, nasal septum deviation, asthma or autoimmune disorders
* 6\. previously received acupuncture therapy for AR within 1 month prior to recruitment
* 7\. women during pregnancy or lactation

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No