Clinical trial NCT04234451: Efficacy, Safety and Underlying Mechanisms of Sphenopalatine Ganglion Acupuncture for Perennial Allergic Rhinitis
Official title: Efficacy, Safety and Underlying Mechanisms of Sphenopalatine Ganglion Acupuncture for Perennial Allergic Rhinitis: a Randomized, Double-blind, Placebo Controlled Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Perennial Allergic Rhinitis
Keywords: Acupuncture
sphenopalatine ganglion
perennial allergic rhinitis
neuropeptides
inflammatory cytokines
neuro-immune interactions
Lead sponsor: Beijing Tongren Hospital
Sponsor class: OTHER
First posted: 2020-01-21
Enrollment: 40
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: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Change from baseline symptom scores at visit 4
timeFrame: Symptom scores will be assessed at baseline (V0), visit 4( V4). V4 is at the second week 15 minutes after the fourth acupuncture.
Secondary outcomes:
measure: Rescue medication score
timeFrame: RMS will be assessed at baseline (V0), and each visit. V1, V2, V3, and V4 is on Day 1, Day 4, Day 8 and Day 11, respectively(+/- 1 day). V5 is at the third week and V6 is at the fourth week. There is no acupuncture during both V5 and V6.
measure: rhinoconjunctivitis quality of life questionnaire (RQLQ)
timeFrame: RQLQ will be assessed at baseline (V0), and each visit. V1, V2, V3, and V4 is on Day 1, Day 4, Day 8 and Day 11, respectively(+/- 1 day). V5 is at the third week and V6 is at the fourth week. There is no acupuncture during both V5 and V6.
measure: nasal patency
timeFrame: NCV, NAR and MCA will be assessed at baseline (V0), and each visit. V1, V2, V3, and V4 is on Day 1, Day 4, Day 8 and Day 11, respectively(+/- 1 day). V5 is at the third week, and V6 at the fourth week.
measure: neuropeptides in nasal secretions
timeFrame: Nasal secretions can be obtained at baseline (V0), V4,V5 and V6. V4 is at the second week. V5 is at the third week and V6 is at the fourth week. There is no acupuncture during both V5 and V6.
measure: inflammatory cytokines in nasal secretions
timeFrame: Nasal secretions can be obtained at baseline (V0), V4 ,V5 and V6. V4 is at the second week. V5 is at the third week and V6 is at the fourth week. There is no acupuncture during both V5 and V6.
measure: adverse events
timeFrame: adverse events will be recorded at baseline (V0), and each visit. V1, V2, V3, and V4 is on Day 1, Day 4, Day 8 and Day 11, respectively(+/- 1 day). V5 is at the third week and V6 is at the fourth week. There is no acupuncture during both V5 and V6.
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Tongren Hospital
state: Beijing
Study officials:
affiliation: Beijing Tongren Hospital
name: Luo Zhang
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: 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.
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.