Acupuncture at the Sphenopalatine Ganglion in the Treatment of Moderate-to-severe Seasonal Allergic Rhinitis

Summary

Allergic rhinitis (AR) is an immunoglobulin E-mediated inflammatory disease1 caused by hypersensitivity of the immune system to an allergen, affecting 100 million people in Europe 2and 400 million of the global population.The etiology of AR is multifactorial, resulting primarily from genetic predisposition, immunological response, and environmental pollutants.AR traditionally has been classified as seasonal (SAR) or perennial (PAR) depending on the causes and duration of symptoms. Some patients with AR prefer complementary and alternative medicine for their symptoms, with nearly 20% receiving acupuncture. According to the updated practice parameter of rhinitis in 2020, the use of acupuncture for the treatment of AR was not recommended due to a lack of well-controlled studies.

The sphenopalatine ganglion (SPG), located under a thin (1-2 mm) layer of mucosa in the pterygopalatine fossa, consists of sensory fibers that innervate the nasopharynx, nasal cavity, and palate.Several studies have reported the benefit of SPG stimulation in chronic cluster headache and acute ischaemic stroke. Compared with traditional acupoints selected on basis of traditional meridian theory, acupuncture at SPG(inserting a needle through SPG acupoint (near ST7, Xiaguan) to reach and directly stimulate the SPG) may help patients ameliorate nasal symptoms immediately and improve quality of life by increasing sympathetic nerve excitability, but the evidence is inconclusive.

We have designed this three-armed, randomized trial to investigate the efficacy and safety of acupuncture at SPG for the treatment of SAR. We hypothesize that acupuncture at SPG plus rescue medication is superior to sham acupuncture plus RM and RM alone in the treatment of SAR.

Conditions

• Seasonal Allergic Rhinitis

Interventions

OTHER

Acupuncture group

Sterile single-use stainless steel needles (size 0.35 mm × 55 mm) (YiDaiFu brand, Suzhou Tianyi Acupuncture Instrument Co., Ltd., Suzhou, China) will be utilized. Participants in lateral position, the acupoints area will be sterilized with 75% alcohol. To stimulate SPG, the needles will be inserted in the medial superior anterior direction to a depth of approximately 55 mm33 until the participants report a special sensation radiating toward the nose or the upper teeth. After that, the needle will be withdrew slightly. The needles will be retained for 30 minutes after three stimulation. Rescue medication are permitted when participants feel that their symptoms are intolerable.

OTHER

Placebo acupuncture group

The acupuncture procedure will be similar to that of the acupuncture group. After sterilizing the skin, the 0.35 × 25 mm disposable needle will be vertically inserted at SPG acupoint about 3-5 mm. No needle manipulation will be conducted to avoid the deqi response. Rescue medication are permitted when participants feel that their symptoms are intolerable.

OTHER

Rescue medication group

Participants in the rescue medication group do not receive acupuncture treatment during the study period. They will be only allowed to use rescue medication. They have the option of 4 weeks (up to 8 sessions) of acupuncture free of charge at the end of the follow-up period.

Sponsors & Collaborators

• Aerospace 731 Hospital

  collaborator OTHER

• Guang'anmen Hospital of China Academy of Chinese Medical Sciences

  lead OTHER

Principal Investigators

• Weiming Wang, MD,PhD · Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-05-01

Primary Completion

2026-10-31

Completion

2026-12-31

Countries

• China

Study Locations