Clinical efficacy on acupuncture for perennial allergic rhinitis: a study protocol for a randomized clinical trial.

IF 3.3 Q2 ALLERGY
Frontiers in allergy Pub Date : 2025-06-16 eCollection Date: 2025-01-01 DOI:10.3389/falgy.2025.1600032
Jia-Xin Yang, Shu-Ren Ming, Hui Chen, Yue-Lai Chen
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引用次数: 0

Abstract

Background: 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.

Methods: 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, n = 42) or control group (accepting sham acupuncture, n = 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.

Conclusion: 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.

Trial registration: Chinese Clinical Trial Registry (ChiCTR2400086227).

针刺治疗常年性变应性鼻炎的临床疗效:一项随机临床试验研究方案。
背景:变应性鼻炎(Allergic rhinitis, 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,许多研究调查了其对AR的治疗效果。然而,由于建立适当的安慰剂对照的挑战,很少有研究直接比较针灸和假针灸治疗AR。本试验探讨针灸与安慰剂针刺治疗变应性鼻炎患者的疗效和耐受性的比较。方法:本临床试验采用分层随机方案,1:1分配,单盲评估,总样本量为84例。筛选入组后,将符合条件的常年性变应性鼻炎患者随机分为治疗组(接受针灸治疗,n = 42)和对照组(接受假针灸治疗,n = 42)。干预将持续4周以上。主要疗效指标为治疗一周后用视觉模拟评分法(VAS)评定主要症状严重程度的变化情况。次要结局包括每次治疗后鼻部症状总评分(TNSS)、疗效指数(%)、起效时间、每周治疗后鼻炎生活质量问卷(RQLQ)评分、抗过敏药物的额外使用率。结论:本研究旨在综合评价针刺治疗常年性变应性鼻炎的疗效和安全性,包括症状缓解、时效关系、生活质量改善、抗过敏药物使用减少等。试验注册:中国临床试验注册中心(ChiCTR2400086227)。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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来源期刊
CiteScore
2.80
自引率
0.00%
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审稿时长
12 weeks
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