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评估针灸对常年性变应性鼻炎的影响:一项随机安慰剂对照针灸试验方案。

Evaluating the impact of acupuncture on perennial allergic rhinitis: A randomized placebo acupuncture control trial protocol.

作者信息

Meng Chunxue, Na Qianxi, Zhang Jing, Cai Zijie, Wang Fei, Zhang Qian, Zhang Shengfu, Zhao Hailong, Tang Xuhong, Chen Ziye, Zhang Qian, Guo Bin

机构信息

The Medical College of Traditional Chinese Medicine, Ningxia Medical University; Ningxia Regional Key Laboratory of Integrated Traditional Chinese and Western Medicine for Prevention and Treatment of High Incidence; Traditional Chinese Medicine University of Guangzhou, China.

出版信息

MethodsX. 2025 May 1;15:103350. doi: 10.1016/j.mex.2025.103350. eCollection 2025 Dec.

Abstract

INTRODUCTION

Allergic rhinitis (AR) poses a significant global health and medical challenge. Acupuncture might serve as a therapeutic modality for allergic rhinitis, however, the empirical support for its clinical effectiveness is currently restricted.The objective of this research is to examine the therapeutic outcomes and tolerability of acupuncture treatment in the context of standard care for allergic rhinitis.

METHODS AND ANALYSIS

A sum of 264 individuals with AR will be assigned at random to either the acupuncture (A) cohort or the placebo acupuncture (PA) cohort in an equal split of 1:1. A regimen of 12 therapeutic sessions will be conducted across a 4-week interval.The primary outcome was the 3-month post-treatment recurrence rate, assessed using the Rhinitis Control Assessment Test (RCAT) score. Additional outcomes encompass, the RQLQ, TNSS,TOSS and RMS.Participant monitoring will be conducted up to the 16th week.All participants who have been randomized will be incorporated in the analysis, with the quantitative evaluation conducted to assess the data.

ETHICS/DISSEMINATION: This protocol has been approved by the Research Ethical Committee of Ningxia Medical University(Permission number:Ning Medical University Ethics No.2024-3766) ChiCTR2500095634.

摘要

引言

过敏性鼻炎(AR)给全球健康和医学带来了重大挑战。针灸可能是治疗过敏性鼻炎的一种方法,然而,目前其临床疗效的实证支持有限。本研究的目的是在过敏性鼻炎的标准护理背景下,检验针灸治疗的疗效和耐受性。

方法与分析

264名AR患者将被随机分为针灸(A)组和假针灸(PA)组,比例为1:1。在4周的时间内进行12次治疗疗程。主要结局是治疗3个月后的复发率,使用鼻炎控制评估测试(RCAT)评分进行评估。其他结局包括RQLQ、TNSS、TOSS和RMS。对参与者的监测将持续到第16周。所有随机分组的参与者都将纳入分析,并进行定量评估以分析数据。

伦理/传播:本方案已获得宁夏医科大学研究伦理委员会批准(批准号:宁医科大学伦理第2024 - 3766号),ChiCTR2500095634。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7ad2/12312109/e8bfcd4ec3a0/gr1.jpg

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