基于经络脏腑相关理论的慢性持续性哮喘针刺治疗研究：中国多中心随机对照临床试验方案。

Acupuncture for chronic persistent asthma based on the theory of Meridian-viscera Association: study protocol for a multi-center randomized controlled trial in China.

机构信息

Acupuncture and Tuina School/The 3rd Teaching Hospital, Chengdu University of Traditional Chinese Medicine, 37# Shierqiao Road, Chengdu, 610075, Sichuan, China.

Acupuncture & Brain Research Center, Chengdu University of Traditional Chinese Medicine, 37# Shierqiao Road, Chengdu, 610075, Sichuan, China.

出版信息

Trials. 2021 Jan 6;22(1):17. doi: 10.1186/s13063-020-04844-8.

DOI:10.1186/s13063-020-04844-8

PMID:33407788

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC7789474/

Abstract

BACKGROUND

Acupuncture is effective in symptom and quality of life improvement of chronic asthma, but the efficacy differences between different acupoints are uncertain. In terms of the theory of Meridian-viscera Association, the study aims to investigate the different effectiveness between acupoints in Lung meridian and the acupoints in Heart meridian, so as to provide the evidence to develop a better prescription of the acupuncture treatment of chronic persistent asthma.

METHODS

This study is a multicentral randomized controlled trial. A total of 68 chronic persistent asthma patients will be randomly allocated into two groups: the Lung meridian group and the Heart meridian group. This trial will include a 2-week baseline period, a 4-week treatment period with 12 sessions' acupuncture, and an 8-week follow-up period. The primary outcome is the Asthma Quality of Life Questionnaire (AQLQ). Secondary outcomes are the Asthma Control Test (ACT), Peak Expiratory Flow (PEF), and Forced Expiratory Volume in 1 s (FEV1). The AQLQ and ACT will be collected at baseline, week 4, week 8, and week 12 after randomization. PEF, FEV1, the Self-rating Anxiety Scale (SAS), and the Self-rating Depression Scale (SDS) will be assessed at baseline and week 4.

DISCUSSION

The results will provide evidence for acupuncture prescription selection and the clinical efficacy improvement. The results of this trial will also be used to determine whether or not a full definitive trial will go ahead, which will further confirm the theory of Meridian-viscera Association.

TRIAL REGISTRATION

Chinese Clinical Trial Registry ( http://www.chictr.org.cn/showproj.aspx?proj=43803 ) ChiCTR1900027284. Registered on 7 November 2019.

摘要

背景

针刺在改善慢性哮喘的症状和生活质量方面是有效的，但不同穴位的疗效差异尚不确定。从经络脏腑相关理论的角度来看，本研究旨在探讨肺经穴位与心经穴位之间的疗效差异，为开发更好的慢性持续性哮喘针灸治疗方案提供依据。

方法

本研究为多中心随机对照试验。共纳入 68 例慢性持续性哮喘患者，随机分为肺经组和心经组。试验包括 2 周的基线期、12 次针刺治疗的 4 周治疗期和 8 周随访期。主要结局指标为哮喘生活质量问卷（AQLQ）。次要结局指标为哮喘控制测试（ACT）、呼气峰流速（PEF）和 1 秒用力呼气量（FEV1）。AQLQ 和 ACT 将在随机分组后第 4 周、第 8 周和第 12 周进行收集。PEF、FEV1、焦虑自评量表（SAS）和抑郁自评量表（SDS）将在基线和第 4 周进行评估。