Acupuncture as adjunctive therapy for patients with AECOPD: study protocol for a multicenter, randomized controlled trial.
acupoint combinations
acupuncture
acute exacerbation of chronic obstructive pulmonary disease
randomized controlled trial
study protocol
Journal
Frontiers in public health
ISSN: 2296-2565
Titre abrégé: Front Public Health
Pays: Switzerland
ID NLM: 101616579
Informations de publication
Date de publication:
2023
2023
Historique:
received:
06
06
2023
accepted:
07
09
2023
medline:
23
10
2023
pubmed:
18
10
2023
entrez:
18
10
2023
Statut:
epublish
Résumé
The acute exacerbation of chronic obstructive pulmonary disease (AECOPD) is a common respiratory disease among older adults, which imposes a significant burden on individuals and society and poses a major challenge to the global public health system due to its high morbidity and mortality. Acupuncture is effective for AECOPD, but its efficacy has been questioned due to the limited methodological quality. Thus, we aim to investigate the efficacy of acupuncture as adjunctive therapy for AECOPD and determine whether the efficacy of acupuncture differs with the type of acupoint combinations. This study proposes a prospective, multicenter randomized controlled trial that will comprise four groups, including two acupuncture treatment groups, one sham acupuncture group, and one basic treatment group. The acupuncture treatment groups will be distinguished by their focus on different patterns of acupoint combination, namely the Xi-cleft and He-sea acupoint combination and the Eight Confluence points acupoint combination, which may vary in clinical efficacy based on traditional acupuncture theories. The study aims to randomize 556 patients in a 1:1:1:1 ratio across the four groups. Each patient in acupuncture group or sham acupuncture group will receive routine drug therapy and 7 sessions of acupuncture treatment over 1 week. Participants in the basic treatment group will only receive routine drug therapy. The trial will be conducted in seven hospitals located in China. The primary outcomes in this trial will include differences in the Breathlessness, Cough, and Sputum Scale (BCSS) before randomization, 7 days after randomization, 5 and 9 weeks after randomization. Ethical approval was obtained from the Sichuan Regional Ethics Review of Committee on Traditional Chinese Medicine (Approval ID: 2022KL-068). The results of this study will be distributed through peer-reviewed journals.
Sections du résumé
Background
The acute exacerbation of chronic obstructive pulmonary disease (AECOPD) is a common respiratory disease among older adults, which imposes a significant burden on individuals and society and poses a major challenge to the global public health system due to its high morbidity and mortality. Acupuncture is effective for AECOPD, but its efficacy has been questioned due to the limited methodological quality. Thus, we aim to investigate the efficacy of acupuncture as adjunctive therapy for AECOPD and determine whether the efficacy of acupuncture differs with the type of acupoint combinations.
Methods and analysis
This study proposes a prospective, multicenter randomized controlled trial that will comprise four groups, including two acupuncture treatment groups, one sham acupuncture group, and one basic treatment group. The acupuncture treatment groups will be distinguished by their focus on different patterns of acupoint combination, namely the Xi-cleft and He-sea acupoint combination and the Eight Confluence points acupoint combination, which may vary in clinical efficacy based on traditional acupuncture theories. The study aims to randomize 556 patients in a 1:1:1:1 ratio across the four groups. Each patient in acupuncture group or sham acupuncture group will receive routine drug therapy and 7 sessions of acupuncture treatment over 1 week. Participants in the basic treatment group will only receive routine drug therapy. The trial will be conducted in seven hospitals located in China. The primary outcomes in this trial will include differences in the Breathlessness, Cough, and Sputum Scale (BCSS) before randomization, 7 days after randomization, 5 and 9 weeks after randomization.
Ethics and dissemination
Ethical approval was obtained from the Sichuan Regional Ethics Review of Committee on Traditional Chinese Medicine (Approval ID: 2022KL-068). The results of this study will be distributed through peer-reviewed journals.
Identifiants
pubmed: 37849714
doi: 10.3389/fpubh.2023.1235672
pmc: PMC10578458
doi:
Banques de données
ChiCTR
['ChiCTR2200064484']
Types de publication
Clinical Trial Protocol
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
1235672Informations de copyright
Copyright © 2023 Yang, Sun, Xu, Luo, Huang, Tian, Gong, Li, Yu, Chen, Huang, Liu, Zhou, Huang, Liu, Tang, Yang, Zeng and Liang.
Déclaration de conflit d'intérêts
The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.
Références
Curr Opin Pulm Med. 2018 Mar;24(2):138-146
pubmed: 29210750
Eur Respir Rev. 2009 Dec;18(114):213-21
pubmed: 20956146
Complement Ther Clin Pract. 2019 May;35:208-218
pubmed: 31003660
Eur Respir J. 2021 Feb 11;57(2):
pubmed: 32855228
J Altern Complement Med. 2008 Nov;14(9):1097-105
pubmed: 19055335
Am J Respir Crit Care Med. 2002 Jul 1;166(1):111-7
pubmed: 12091180
Zhen Ci Yan Jiu. 2016 Jun 25;41(3):251-4
pubmed: 29071915
Thorax. 2014 Feb;69(2):137-43
pubmed: 24005444
Respir Care. 2018 May;63(5):591-600
pubmed: 29692353
Eur Respir J. 2013 Oct;42(4):946-55
pubmed: 23349446
Int J Chron Obstruct Pulmon Dis. 2015 Feb 12;10:347-56
pubmed: 25709429
Zhongguo Zhen Jiu. 2021 Dec 12;41(12):1399-403
pubmed: 34936282
Arch Intern Med. 2012 Jun 11;172(11):878-86
pubmed: 22905352
Int J Chron Obstruct Pulmon Dis. 2021 Jul 07;16:2023-2037
pubmed: 34262271
MMWR Morb Mortal Wkly Rep. 2012 Nov 23;61(46):938-43
pubmed: 23169314
Complement Ther Med. 2019 Dec;47:102182
pubmed: 31780020
BMJ. 2014 Sep 22;349:g5237
pubmed: 25245156
Zhen Ci Yan Jiu. 2022 Jul 25;47(7):630-5
pubmed: 35880281
Eur Respir J. 2018 Oct 25;52(4):
pubmed: 30190274
JAMA. 2013 Nov 27;310(20):2191-4
pubmed: 24141714
Am J Respir Crit Care Med. 2017 Dec 1;196(11):1463-1472
pubmed: 29192835
Zhongguo Zhen Jiu. 2022 May 12;42(5):579-82
pubmed: 35543953
Thorax. 2005 Nov;60(11):925-31
pubmed: 16055622
Drugs Aging. 2008;25(5):415-43
pubmed: 18447405
BMJ. 2013 Jan 08;346:e7586
pubmed: 23303884
Front Public Health. 2022 Dec 23;10:1046773
pubmed: 36620296
Chest. 2003 Dec;124(6):2182-91
pubmed: 14665499
Eur Respir J. 2005 Jul;26(1):153-61
pubmed: 15994402
PLoS Med. 2006 Nov;3(11):e442
pubmed: 17132052
J Glob Health. 2017 Dec;7(2):020704
pubmed: 29423187
JAMA. 2005 May 4;293(17):2118-25
pubmed: 15870415
Respirology. 2016 Jan;21(1):14-23
pubmed: 26494423
Lancet Respir Med. 2017 Aug;5(8):619-626
pubmed: 28668356
Eur J Intern Med. 2020 Mar;73:1-6
pubmed: 31954592
Acupunct Med. 2010 Jun;28(2):83-93
pubmed: 20615861
BMJ. 2005 Aug 13;331(7513):376-82
pubmed: 16055451
Trials. 2008 Oct 20;9:57
pubmed: 18928574
Zhongguo Zhen Jiu. 2021 Jul 12;41(7):703-10
pubmed: 34259398
Eur Respir J. 2009 Sep;34(3):648-54
pubmed: 19720809
Eur Respir J. 2006 Feb;27(2):397-412
pubmed: 16452599
Cochrane Database Syst Rev. 2004 Oct 18;(4):CD000245
pubmed: 15494994
Zhen Ci Yan Jiu. 2020 Feb 25;45(2):169-72
pubmed: 32144930
Acupunct Med. 2022 Dec;40(6):505-515
pubmed: 35579025
Chin Med J (Engl). 2008 Apr 5;121(7):587-91
pubmed: 18466676