天灸疗法治疗变应性鼻炎：一项随机对照试验的研究方案

Tian Jiu therapy for allergic rhinitis: study protocol for a randomized controlled trial.

作者信息

Kun Wai, Zhong Linda L D, Dai Liang, Cheng Chung-Wah, Lu Ai-Ping, Bian Zhao-Xiang

机构信息

School of Chinese Medicine, Hong Kong Baptist University, 7 Baptist University Road, Kowloon Tong, Hong Kong, China.

Hong Kong Chinese Medicine Clinical study Center, Hong Kong Baptist University, 205, Jockey Club School of Chinese Medicine Building, 7 Baptist University Road, Kowloon Tong, Kowloon, Hong Kong.

出版信息

Trials. 2016 May 17;17(1):248. doi: 10.1186/s13063-016-1374-5.

DOI:10.1186/s13063-016-1374-5

PMID:27189087

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC4869399/

Abstract

BACKGROUND

Allergic rhinitis (AR) is one of the most common allergic diseases. The conventional treatments of allergic rhinitis are oral anti-histamines, the use of intranasal corticosteroids, and immunotherapy. Dissatisfied with the ineffectiveness and side effects of these treatments, substantial numbers of patients are turning to alternative treatments like Chinese herbal medicine, particularly Tian Jiu (TJ). TJ is a form of moxibustion in which herbal patches are applied to specific acupoints on the skin. This study aims to investigate the efficacy and safety of TJ in the treatment of allergic rhinitis.

METHODS/DESIGN: This will be a prospective, randomized, single-blinded, controlled trial in patients with AR. After a 1-week run-in period, eligible subjects will be randomly assigned to the TJ group, placebo-control group or waitlist-control group. The TJ and placebo-control groups will undergo a 4-week treatment with one session per week and one 4-week post-treatment follow-up. Participants in the waitlist-control group will not receive any treatment during the first 4 weeks but will be required to be assessed. The primary outcome will be the change in the weekly average of the Total Nasal Symptom Score recorded from baseline to the end of treatment. The secondary outcomes will be change in symptoms and change in need for medication between baseline and the end of treatment by using the Rhinitis Quality of Life Questionnaire. Rescue medication (RM) needs will be measured using an RM score, comprising the weekly sum of daily assessments and any form of systemic steroids for allergic rhinitis.

DISCUSSION

This study will be the first study to compare TJ treatment for allergic rhinitis with a placebo-control group, and a waitlist-control group. The investigation of TJ for allergic rhinitis will also suggest recommendations for clinical practice. The results of this study are expected to provide consolidated evidence for the effectiveness and safety of TJ for the treatment of patients with allergic rhinitis.

TRIAL REGISTRATION

NCT02470845 (17 May 2015).

摘要

背景

变应性鼻炎（AR）是最常见的变应性疾病之一。变应性鼻炎的传统治疗方法包括口服抗组胺药、使用鼻内皮质类固醇和免疫疗法。由于对这些治疗方法的无效性和副作用不满意，大量患者转向替代疗法，如中药，特别是天灸（TJ）。天灸是一种艾灸形式，将草药贴剂贴于皮肤上的特定穴位。本研究旨在探讨天灸治疗变应性鼻炎的疗效和安全性。

方法/设计：这将是一项针对变应性鼻炎患者的前瞻性、随机、单盲、对照试验。经过1周的导入期后，符合条件的受试者将被随机分配到天灸组、安慰剂对照组或候补对照组。天灸组和安慰剂对照组将接受为期4周的治疗，每周一次，治疗后进行4周的随访。候补对照组的参与者在最初4周内不接受任何治疗，但需要进行评估。主要结局将是从基线到治疗结束记录的总鼻症状评分每周平均值的变化。次要结局将是使用鼻炎生活质量问卷评估基线至治疗结束期间症状的变化和药物需求的变化。急救药物（RM）需求将使用RM评分进行测量，该评分包括每日评估的每周总和以及任何形式的变应性鼻炎全身用类固醇。