针刺三鼻穴加穴位贴敷治疗常年性变应性鼻炎的疗效：一项多中心、随机对照试验方案。
Efficacy of acupuncture at three nasal acupoints plus acupoint application for perennial allergic rhinitis: A multicenter, randomized controlled trial protocol.
机构信息
Department of Acupuncture and Moxibustion, Shanghai General Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, China.
Acumox and Tuina Research Section, College of Acumox and Tuina, Shanghai University of Traditional Chinese Medicine, Shanghai, China.
出版信息
Trials. 2020 Jan 28;21(1):110. doi: 10.1186/s13063-019-4039-3.
BACKGROUND
Many studies have shown the potential therapeutic effect of acupuncture on allergic rhinitis. Most of these studies were limited by low-quality evidence. Preliminary experiments showed that the use of acupuncture at three nasal acupoints plus acupoint application (AAP) achieves a more persistent effect in the treatment of perennial allergic rhinitis than acupuncture alone. In this study, a multicenter, single-blind, randomized controlled trial will be performed, in which acupuncture at nonmeridian acupoints and sham AAP will be used as the control group to evaluate the effect of AAP through long-term observation.
METHODS
The trial is designed on the basis of the Consolidated Standards of Reporting Trials 2010 guidelines and Standards for Reporting Interventions in Controlled Trials of Acupuncture. A total of 120 participants with perennial allergic rhinitis will be randomly assigned to a treatment or control group. A specially appointed investigator will be in charge of randomization. The participants in the treatment group will be treated with acupuncture at EX-HN3, LI20, and EX-HN8 thrice per week for a total of 12 sessions. In addition, they will undergo AAP at DU14, BL13, EX-BI, and RN22. The participants in the control group will be treated with sham AAP. The primary outcome will be the change in the Total Nasal Symptom Score from baseline to the completion of 4-week treatment. Secondary outcomes include changes in visual analog scale and total non-nasal symptom scores from baseline to the second and fourth weeks of treatment, as well as 1, 3, and 6 months after the completion of treatment. Peripheral blood IL-4, IL-5, IL-6, IL-8, and IL-10 levels will be measured, and any side effects related to treatment will be observed and recorded.
DISCUSSION
It is expected that this randomized clinical trial will provide evidence to determine the effects of AAP compared with acupuncture at nonmeridian acupoints and sham AAP, particularly the long-term effect. These findings will help improve the clinical application of this technique.
TRIAL REGISTRATION
Acupuncture-Moxibustion Clinical Trial Registry AMCTR-ICR-18000179. Registered on 12 April 2018.
背景
许多研究表明针刺治疗变应性鼻炎具有潜在的治疗效果。这些研究大多受到低质量证据的限制。初步实验表明，与单纯针刺相比，针刺三个鼻穴加穴位敷贴（AAP）在治疗常年性变应性鼻炎方面具有更持久的效果。本研究采用多中心、单盲、随机对照试验，以非经穴针刺加假 AAP 作为对照组，通过长期观察评估 AAP 的疗效。
方法
试验基于 2010 年 CONSORT 报告标准和针刺对照临床试验标准进行设计。共纳入 120 例常年性变应性鼻炎患者，随机分为治疗组和对照组。由指定的研究者进行随机分组。治疗组每周治疗 3 次，共治疗 12 次，穴位为 EX-HN3、LI20 和 EX-HN8。同时给予穴位敷贴 DU14、BL13、EX-BI 和 RN22。对照组给予假 AAP。主要结局为 4 周治疗结束时总鼻部症状评分的变化。次要结局包括从基线到治疗第 2 周和第 4 周时视觉模拟评分和总非鼻部症状评分的变化，以及治疗结束后 1、3 和 6 个月的变化。检测外周血白细胞介素-4、白细胞介素-5、白细胞介素-6、白细胞介素-8 和白细胞介素-10 水平，并观察和记录与治疗相关的任何不良反应。
讨论
预计这项随机临床试验将提供证据，以确定穴位敷贴与非经穴针刺和假 AAP 的疗效，特别是长期疗效。这些发现将有助于提高该技术的临床应用。
试验注册
针灸临床试验注册中心 AMCTR-ICR-18000179。注册于 2018 年 4 月 12 日。
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