Clinical trial NCT03282630: The Effects of Sphenopalatine Ganglion Acupuncture in Patients With Seasonal Allergic Rhinitis
Official title: The Effects of Sphenopalatine Ganglion Acupuncture in Patients With Seasonal Allergic Rhinitis: A Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Patients
Keywords: Acupuncture
Sphenopalatine ganglion
Allergic rhinitis
Randomized Trial
Lead sponsor: Beijing Tongren Hospital
Sponsor class: OTHER
First posted: 2017-09-14
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Sphenopalatine ganglion (SPG)-acupuncture has been shown to exhibit distinct effects in treatment of nasal inflammatory disease. Investigators aimed to assess the effects of SPG acupuncture in patients with seasonal allergic rhinitis. The randomized, double-blind, controlled clinical trial enrolled participants with seasonal allergic rhinitis. Participants will be randomly assigned to either active SPG-acupuncture group or sham-acupuncture group. All participants will be provided four times of acupuncture in 4 weeks, and then follow-up of 4 week.

Primary trial outcomes are change in symptoms and change in need for medication. The primary outcomes will be measured in baseline, week1, week2, week3, week4, week 6 and week 8. Secondary outcomes include the changes in nasal patency (nasal airway resistance and nasal cavity volume), exhaled nasal nitric oxide.The investigators also evaluate change in neuropeptides (substance P, vasoactive intestinal peptide,neuropeptide Y) and inflammatory cytokines (interleukin(IL)-4, IL-5, IL-8, IL-17a, IL-22, IL-25, interferon-γ, tumor necrosis factor-α, transforming growth factor(TGF)-β1, TGF-β2, TGF-β3,Chemokine, Eotaxin) in nasal secretions as secondary outcomes. The secondary outcomes will be measured in baseline, week1, week4 and week 8.


Eligibility criteria: Inclusion Criteria:

* patients with a history of at least 2 years of seasonal allergic rhinitis
* no smoking
* without history of nasal polyps, nasal septum deviation and history of nose surgery) or lung disease (asthma, chronic obstructive pulmonary disease and fibrosis)
* free of upper and lower respiratory tract infections for at least 4 weeks before beginning the study.

Exclusion Criteria:

* had received acupuncture within the last four weeks before the study
* history of diabetes mellitus, autonomic neuropathy, coronary heart disease or hypertension.

Primary outcomes:
measure: The change of symptoms
timeFrame: The primary outcomes will be measured in baseline, week1, week2, week3, week4, week 6 and week 8.
measure: The change of need for medication
timeFrame: The primary outcomes will be measured in baseline, week1, week2, week3, week4, week 6 and week 8.
Secondary outcomes:
measure: The change of nasal patency
timeFrame: The outcomes will be measured in baseline, week1, week4 and week 8.
measure: The change of exhaled nasal nitric oxide
timeFrame: The outcomes will be measured in baseline, week1, week4 and week 8.
measure: The change of substance P, vasoactive intestinal peptide and neuropeptide Y in nasal secretions
timeFrame: The outcomes will be measured in baseline, week1, week4 and week 8.
measure: The change of inflammatory cytokines in nasal secretions
timeFrame: The outcomes will be measured in baseline, week1, week4 and week 8.
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Tongren Hospital
state: Beijing
Study officials:
affiliation: Beijing Tongren Hospital
name: Chengshuo Wang
role: PRINCIPAL_INVESTIGATOR
References:
citation: Choi SM, Park JE, Li SS, Jung H, Zi M, Kim TH, Jung S, Kim A, Shin M, Sul JU, Hong Z, Jiping Z, Lee S, Liyun H, Kang K, Baoyan L. A multicenter, randomized, controlled trial testing the effects of acupuncture on allergic rhinitis. Allergy. 2013 Mar;68(3):365-74. doi: 10.1111/all.12053. Epub 2012 Dec 18.
citation: Xue CC, Zhang AL, Zhang CS, DaCosta C, Story DF, Thien FC. Acupuncture for seasonal allergic rhinitis: a randomized controlled trial. Ann Allergy Asthma Immunol. 2015 Oct;115(4):317-324.e1. doi: 10.1016/j.anai.2015.05.017. Epub 2015 Jun 11.
citation: Brinkhaus B, Ortiz M, Witt CM, Roll S, Linde K, Pfab F, Niggemann B, Hummelsberger J, Treszl A, Ring J, Zuberbier T, Wegscheider K, Willich SN. Acupuncture in patients with seasonal allergic rhinitis: a randomized trial. Ann Intern Med. 2013 Feb 19;158(4):225-34. doi: 10.7326/0003-4819-158-4-201302190-00002.
citation: Wang K, Chen L, Wang Y, Wang C, Zhang L. Sphenopalatine Ganglion Acupuncture Improves Nasal Ventilation and Modulates Autonomic Nervous Activity in Healthy Volunteers: A Randomized Controlled Study. Sci Rep. 2016 Jul 18;6:29947. doi: 10.1038/srep29947.