Yang Jia-Xin, Ming Shu-Ren, Chen Hui, Chen Yue-Lai
Longhua Hospital, Shanghai University of Traditional Chinese Medicine, Shanghai, China.
Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai, China.
Front Allergy. 2025 Jun 16;6:1600032. doi: 10.3389/falgy.2025.1600032. eCollection 2025.
Allergic rhinitis (AR) is a prevalent allergic disorder. Acupuncture has been widely utilized to alleviate allergic symptoms, and numerous studies have investigated its therapeutic effects on AR. However, due to the challenges associated with establishing appropriate placebo controls, few studies have directly compared acupuncture with sham acupuncture for AR treatment. This trial investigates the comparative effectiveness and tolerability of acupuncture vs. placebo needling for allergic rhinitis patients.
This clinical trial features a stratified randomization scheme with 1:1 allocation, single-blind assessment, and a total sample size of 84 participants. After screening for inclusion, qualified subjects with perennial allergic rhinitis will be randomly allocated to treatment group(accepting acupuncture, = 42) or control group (accepting sham acupuncture, = 42). The intervention will last over a 4-week period. The main efficacy outcome is the change in main symptom severity assessed by the Visual Analogue Scale (VAS) after each week of treatment. Secondary outcomes include the Total Nasal Symptom Score (TNSS), Efficacy Index (%) after each treatment session, time to onset of effect, Rhinitis Quality of Life Questionnaire (RQLQ) scores after each week of treatment, and the additional use rate of anti-allergic medications.
The findings of this study aims to evaluate the effectiveness and safety of acupuncture in treating perennial allergic rhinitis through comprehensive assessment of symptom relief, time-effect relationships, quality of life improvements, and reduction in anti-allergic medication use.
Chinese Clinical Trial Registry (ChiCTR2400086227).
过敏性鼻炎（AR）是一种常见的过敏性疾病。针灸已被广泛用于缓解过敏症状，并且众多研究已经调查了其对AR的治疗效果。然而，由于建立适当的安慰剂对照存在挑战，很少有研究直接比较针灸与假针灸治疗AR的效果。本试验调查针灸与安慰剂针刺对过敏性鼻炎患者的相对疗效和耐受性。
本临床试验采用分层随机化方案，分配比例为1:1，单盲评估，总样本量为84名参与者。在筛选纳入后，符合条件的常年性过敏性鼻炎受试者将被随机分配到治疗组（接受针灸，n = 42）或对照组（接受假针灸，n = 42）。干预将持续4周。主要疗效指标是治疗每周后通过视觉模拟量表（VAS）评估的主要症状严重程度的变化。次要指标包括总鼻症状评分（TNSS）、每次治疗后的疗效指数（%）、起效时间、治疗每周后的鼻炎生活质量问卷（RQLQ）评分以及抗过敏药物的额外使用率。
本研究结果旨在通过综合评估症状缓解、时效关系、生活质量改善以及抗过敏药物使用减少情况，评估针灸治疗常年性过敏性鼻炎的有效性和安全性。
中国临床试验注册中心（ChiCTR2400086227）。
