Shirui Cheng1,2, Xiaohui Dong1,2, Lei Lan1,2, Zhaoxuan He1,2, Siyi Yu1,2, Yi Yang2,3, Chuantao Zhang4, Mei Chen5, Jun Yang6, Haoran Chu7, Yalan Liu1,2, Menglin Wang1,2, Qingsong Huang8, Fang Zeng9,10. 1. Acupuncture and Tuina School/The 3rd Teaching Hospital, Chengdu University of Traditional Chinese Medicine, 37# Shierqiao Road, Chengdu, 610075, Sichuan, China. 2. Acupuncture & Brain Research Center, Chengdu University of Traditional Chinese Medicine, 37# Shierqiao Road, Chengdu, 610075, Sichuan, China. 3. School of Administration, Chengdu University of Traditional Chinese Medicine, Chengdu, 610075, Sichuan, China. 4. The First Affiliated Hospital of Chengdu University of Traditional Chinese Medicine, 39# Shierqiao Road, Chengdu, 610075, Sichuan, China. 5. The Fifth People's Hospital of Chengdu, Chengdu, 611130, Sichuan, China. 6. The First Affiliated Hospital of Anhui University of Traditional Chinese Medicine, Hefei, Anhui, China. 7. The Second Affiliated Hospital of Anhui University of Traditional Chinese Medicine, Hefei, 230031, Anhui, China. 8. The First Affiliated Hospital of Chengdu University of Traditional Chinese Medicine, 39# Shierqiao Road, Chengdu, 610075, Sichuan, China. hqs1261@126.com. 9. Acupuncture and Tuina School/The 3rd Teaching Hospital, Chengdu University of Traditional Chinese Medicine, 37# Shierqiao Road, Chengdu, 610075, Sichuan, China. zeng_fang@cdutcm.edu.cn. 10. Acupuncture & Brain Research Center, Chengdu University of Traditional Chinese Medicine, 37# Shierqiao Road, Chengdu, 610075, Sichuan, China. zeng_fang@cdutcm.edu.cn.
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.
RCT Entities:
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 asthmapatients 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.
Entities:
Keywords:
Acupuncture; Chronic persistent asthma; Protocol; Randomized controlled trial; Theory of Meridian-viscera Association
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