Deptartment of Ophthalmology, Otolaryngology, and Dermatology, College of Korean Medicine, Woo-Suk University, 54987, 46 Eoeun-ro, Wansan-gu, Jeonju-si, Jeollabuk-do, Republic of Korea.
Clinical Medicine Division, Korea Institute of Oriental Medicine, 34054, 1672, Yuseongdae-ro, Yuseong-gu, Daejeon, Republic of Korea.
Explore (NY). 2022 Nov-Dec;18(6):676-682. doi: 10.1016/j.explore.2022.02.006. Epub 2022 Feb 15.
Intranasal low-level laser therapy (LLLT) has already proven its immunosuppressive effects on allergic rhinitis (AR) in experimental studies; however, there is a dearth of clinical evidence supporting its effects in treating AR. The aim of this study was to assess the safety and effectiveness of intranasal LLLT in the treatment of AR compared with acupuncture.
A total of 80 patients with AR participated and were randomly assigned to the intranasal LLLT or acupuncture treatment (AT) group. They were given each treatment for 20 min 3 times a week for 4 weeks.
Both groups improved the total nasal symptom score (TNSS), rhinoconjunctivitis quality of life questionnaire (RQLQ) score, and nasal endoscopy index in patients with AR after 4 weeks of treatment, and these effects extended 4 weeks after the end of treatment. Intranasal LLLT was noninferior to AT in regard to the TNSS. The estimated outcome difference between baseline and the 5th week was -0.38 points (upper 97.5% confidence limit 1.06 points), which was within the noninferiority margin of 2 points. The effect size of the TNSS at the 5th week was 0.19, which was close to Cohen's small effect size. There were no significant differences between two groups regarding the RQLQ, nasal endoscopy index, total serum immunoglobulin E level or absolute eosinophil count.
This study showed that intranasal LLLT is noninferior compared to AT in terms of the TNSS; thus, it may be used as an alternative or adjunctive treatment option for relieving symptoms of AR.
This study was registered at the Korean National Clinical Trial Registry, Clinical Research Information Service (KCT0004079).
鼻内低水平激光疗法（LLLT）已在实验研究中证明对过敏性鼻炎（AR）具有免疫抑制作用；然而，临床证据支持其治疗 AR 的效果却很少。本研究旨在评估与针灸相比，鼻内 LLLT 治疗 AR 的安全性和有效性。
共有 80 名 AR 患者参与并随机分为鼻内 LLLT 或针灸治疗（AT）组。他们每周接受 3 次，每次 20 分钟，共 4 周。
两组患者的总鼻症状评分（TNSS）、鼻结膜炎生活质量问卷（RQLQ）评分和鼻内镜指数在治疗 4 周后均得到改善，并且这些效果在治疗结束后 4 周仍持续存在。在 TNSS 方面，鼻内 LLLT 与 AT 无差异。从基线到第 5 周的估计结局差异为-0.38 分（上限 97.5%置信限为 1.06 分），在 2 分的非劣效性边界内。第 5 周 TNSS 的效应量为 0.19，接近 Cohen 的小效应量。两组患者的 RQLQ、鼻内镜指数、总血清免疫球蛋白 E 水平或绝对嗜酸性粒细胞计数无显著差异。
本研究表明，在 TNSS 方面，鼻内 LLLT 与 AT 相比非劣效，因此，它可能作为缓解 AR 症状的替代或辅助治疗选择。
本研究在韩国国家临床试验注册处（KCT0004079）进行注册。
