Allergic rhinitis can cause sneezing, a runny or blocked nose, and nasal itching, which may affect daily activities and quality of life. Nasal corticosteroid sprays are commonly used to control these symptoms, but some people may still have bothersome symptoms.
The purpose of this study is to find out whether adding sphenopalatine ganglion acupuncture to mometasone furoate nasal spray can improve allergic rhinitis symptoms more than using the nasal spray alone, and to evaluate the safety of this treatment.
Adults with moderate-to-severe perennial allergic rhinitis will be randomly assigned to one of two treatment groups. Both groups will use mometasone furoate nasal spray for 4 weeks. Participants in one group will also receive sphenopalatine ganglion acupuncture twice a week for 4 weeks. Researchers will compare changes in nasal symptoms, quality of life, use of rescue medication, clinical examination findings, and adverse events between the two groups. Participants will also be followed after treatment to assess whether the treatment effects are maintained.
At least two of the following symptoms: paroxysmal sneezing, watery rhinorrhea, nasal itching, and nasal obstruction, with symptoms lasting or accumulating for at least 1 hour per day; ocular symptoms such as itching, tearing, or redness may also be present.
Anterior rhinoscopy or nasal endoscopy showing findings consistent with allergic rhinitis, such as pale or edematous nasal mucosa, turbinate swelling, and watery nasal secretions.
At least one positive allergen test, including a skin prick test, serum allergen-specific immunoglobulin E (sIgE) test, or nasal allergen provocation test.
No use of antihistamines, intranasal or systemic corticosteroids, leukotriene receptor antagonists, allergen immunotherapy, or other treatments that may affect efficacy assessment within 2 weeks before enrollment.
Presence of acute upper respiratory tract infection, acute or chronic rhinosinusitis, nasal polyps, severe nasal septal deviation, rhinitis medicamentosa, vasomotor rhinitis, infectious rhinitis, or other forms of non-allergic rhinitis.
Presence of an autoimmune disease or a psychiatric or psychological disorder that may interfere with study participation or outcome assessment.
Pregnancy or breastfeeding.
Coagulation disorders, current use of anticoagulant medications, local skin infection at the acupuncture site, a tendency to develop excessive scarring, or inability to tolerate acupuncture.
Parallel
Sphenopalatine Ganglion Acupuncture
Procedure/SurgerySphenopalatine ganglion acupuncture will be performed twice weekly for 4 consecutive weeks, for a total of 8 treatment sessions. Acupuncture will be performed alternately on the left and right sides without needle retention.
Mometasone furoate nasal spray
DrugMometasone furoate nasal spray will be administered as two sprays into each nostril once daily for 4 consecutive weeks.
Change From Baseline in Total Nasal Symptom Score
Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire Score
Total Non-Nasal Symptom Score
Change From Baseline in Nasal Examination Score
Number of Days of Rescue Medication Use
The total number of calendar days on which each participant uses at least one dose of protocol-permitted rescue medication during the 4-week treatment period will be recorded.
Change From Baseline in Peripheral Blood Eosinophil Count
Peripheral blood eosinophil count will be measured at baseline and Week 4. Change from baseline will be calculated as the Week 4 value minus the baseline value.
Incidence of Treatment-Emergent Adverse Events
The number and proportion of participants experiencing adverse events during the study will be recorded. Acupuncture-related adverse events may include local pain, subcutaneous bleeding or hematoma, dizziness or fainting during acupuncture, needle-related complications, discomfort during mouth opening or chewing, gingival or maxillary discomfort, epistaxis, and local infection. Drug-related adverse events may include nasal dryness, epistaxis, throat discomfort, dry mouth, dizziness, rash, and other allergic reactions. The severity, management, outcome, and relationship of each adverse event to the study intervention will be assessed.
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