Acupuncture improves the symptoms, gut microbiota, metabolomics, and inflammation of patients with chronic obstructive pulmonary disease: a multicenter, randomized, sham-controlled trial protocol.

IF 3.1 3区 医学 Q1 MEDICINE, GENERAL & INTERNAL Frontiers in Medicine Pub Date : 2025-03-03 eCollection Date: 2025-01-01 DOI:10.3389/fmed.2025.1511275
Yilin Liu, Qin Luo, Junqi Li, Chunyan Yang, Fengyuan Huang, Guixing Xu, Fanrong Liang
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Abstract

Background: Chronic obstructive pulmonary disease (COPD) is a common chronic respiratory disease. The occurrence of COPD is associated with gut microbiota, meticulous metabolism and inflammation. Acupuncture may be effective as an adjunctive therapy for COPD, but the available evidence is limited. This study aims to confirm whether acupuncture therapy has an adjunctive therapeutic effect on COPD and to investigate the relationship between the efficacy and the gut microbiota, metabolomics and inflammation.

Methods: This study is a multicenter randomized controlled trial. A total of 72 patients with stable COPD eligible will be randomized in a 1:1 ratio to receive either manual acupuncture (MA) or sham acupuncture (SA) without puncturing the skin. There will be no changes to the essential medicines used for all patients. The intervention will be 12 weeks, 3 times per week and follow-up will be 52 weeks. The primary outcome will be the change in COPD Assessment Test (CAT) score before and after treatment. Secondary outcomes will include modified Medical Research Council (mMRC), St. George's Respiratory Questionnaire (SGRQ), 6-min walk test (6MWT), and the number of moderate or severe acute exacerbations during follow-up. A total of 36 healthy volunteers will also be recruited as normal control. In addition, feces and blood will be collected from each participant to characterize the gut microbiota, metabolomics, immune cells and inflammatory cytokines. Differences between COPD patients and healthy participants will be observed, as well as changes before and after treatment in MA and SA groups. Ultimately, the correlation among gut microbiota, metabolomics, immune cells, inflammatory cytokines and clinical efficacy in COPD patients will be analyzed.

Discussion: This study will evaluate the efficacy and provide preliminary possible mechanisms of acupuncture as an adjunctive therapy in treating COPD. In addition, it will identify biomarkers of the gut microbiota, metabolites, immune cells, and inflammatory cytokines associated with therapeutic efficacy. The results of this study will be published in a peer-reviewed journal.

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来源期刊
Frontiers in Medicine
Frontiers in Medicine Medicine-General Medicine
CiteScore
5.10
自引率
5.10%
发文量
3710
审稿时长
12 weeks
期刊介绍: Frontiers in Medicine publishes rigorously peer-reviewed research linking basic research to clinical practice and patient care, as well as translating scientific advances into new therapies and diagnostic tools. Led by an outstanding Editorial Board of international experts, this multidisciplinary open-access journal is at the forefront of disseminating and communicating scientific knowledge and impactful discoveries to researchers, academics, clinicians and the public worldwide. In addition to papers that provide a link between basic research and clinical practice, a particular emphasis is given to studies that are directly relevant to patient care. In this spirit, the journal publishes the latest research results and medical knowledge that facilitate the translation of scientific advances into new therapies or diagnostic tools. The full listing of the Specialty Sections represented by Frontiers in Medicine is as listed below. As well as the established medical disciplines, Frontiers in Medicine is launching new sections that together will facilitate - the use of patient-reported outcomes under real world conditions - the exploitation of big data and the use of novel information and communication tools in the assessment of new medicines - the scientific bases for guidelines and decisions from regulatory authorities - access to medicinal products and medical devices worldwide - addressing the grand health challenges around the world
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