Open AccessEffects and safety of intranasal phototherapy for allergic rhinitis
Author(s) -
JeongIn Kang,
Go-Eun Lee,
Mi Ju Son,
Youngeun Kim,
Nam Hun Heo,
DongHyo Lee
Publication year - 2020
Publication title -
medicine
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.59
H-Index - 148
eISSN - 1536-5964
pISSN - 0025-7974
DOI - 10.1097/md.0000000000021183
Subject(s) - medicine , nasal administration , randomized controlled trial , clinical trial , adverse effect , acupuncture , eosinophil , quality of life (healthcare) , physical therapy , asthma , immunology , alternative medicine , pathology , nursing
Allergic rhinitis (AR) is an immunoglobulin E (Ig E)-mediated inflammatory disease. Intranasal phototherapy is a promising treatment modality because it has a profound immunosuppressive effect, but the evidence of its use for AR is insufficient. Therefore, rigorously designed randomized controlled trials (RCTs) are needed. Our objective is to describe the protocol for an RCT to assess the effects and safety of intranasal phototherapy for the treatment of AR. Methods and analysis: This is a study protocol for a single-center, randomized, parallel (acupuncture-controlled), open-label, investigator-initiated, pilot study. A total of 80 patients with AR will be randomly assigned to the intranasal phototherapy or acupuncture group at a 1:1 ratio. The participants will receive intranasal phototherapy with medical or acupuncture treatment for 20 minutes, 3 times a week for 4 weeks. The primary outcome will be the mean change in the total nasal symptom score (TNSS) from baseline to 4 weeks. The secondary outcomes will include the Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) score, Nasal Endoscopy Index, total serum immunoglobulin E (Ig E) level and eosinophil count. Discussion: The findings of this study will provide the basis for the design and implementation of RCTs investigating the effects and safety of intranasal phototherapy for AR. Additionally, it will provide preliminary evidence of intranasal phototherapy for use in AR. Trial registration: This study was registered at the Korean National Clinical Trial Registry, Clinical Research Information Service (KCT0004079).