Effectiveness of Xin Jia Xuan Bai Cheng Qi Decoction in treating acute exacerbation of chronic obstructive pulmonary disease: study protocol for a multicentre, randomised, controlled trial

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Abstract

Introduction

Acute exacerbation of chronic obstructive pulmonary disease (AECOPD) brings a serious impact on patients’ quality of life, and has extremely high morbidity and mortality worldwide. Although there are many therapies being developed to alleviate symptoms and reduce mortality, a few studies have supported which treatment method is the best. Traditional Chinese medicine (TCM) has shown good potential in the prevention and treatment of AECOPD, especially in terms of supplementation and reduction of dosage and adverse effect of Western medicine. The purpose of this study is to compare the effectiveness of combination of TCM and Western medicine with conventional therapy alone for AECOPD, and to ensure whether the combined therapy may reduce the use of systemic glucocorticoid in AECOPD without influencing efficacy.

Methods and analysis

A multicentre, randomised, double-blind, placebo-controlled study was conducted to enrol a total of 360 eligible patients who will be randomised into integrated Chinese and Western medicine group A, B and Western standard Medicine group C. After 5 days of intervention and 1 month of follow-up, the efficacy and safety of Xin Jia Xuan Bai Cheng Qi Decoction in patients with AECOPD will be observed. The results of evaluation indicators include: clinical symptoms, biochemical indicators such as blood gas analysis, inflammatory markers, hospitalisation time, TCM syndrome evaluation, biological indicators such as airway, intestinal flora sequencing.

Ethics and dissemination

This trail has been approved by the Ethics Committee of China-Japan Friendship Hospital. The results will be disseminated in international peer-reviewed journals and be presented in academic conferences. The results will also be disseminated to patients by telephone, inquiring on patient’s poststudy health status during the follow-up.

Trial registration number

ChiCTR1800016915

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Most cited references 17

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Exacerbations of COPD

Ian Pavord, Paul W Jones, Pierre-Régis Burgel … (2016)

Exacerbations of chronic obstructive pulmonary disease (COPD) are defined as sustained worsening of a patient’s condition beyond normal day-to-day variations that is acute in onset, and that may also require a change in medication and/or hospitalization. Exacerbations have a significant and prolonged impact on health status and outcomes, and negative effects on pulmonary function. A significant proportion of exacerbations are unreported and therefore left untreated, leading to a poorer prognosis than those treated. COPD exacerbations are heterogeneous, and various phenotypes have been proposed which differ in biologic basis, prognosis, and response to therapy. Identification of biomarkers could enable phenotype-driven approaches for the management and prevention of exacerbations. For example, several biomarkers of inflammation can help to identify exacerbations most likely to respond to oral corticosteroids and antibiotics, and patients with a frequent exacerbator phenotype, for whom preventative treatment is appropriate. Reducing the frequency of exacerbations would have a beneficial impact on patient outcomes and prognosis. Preventative strategies include modification of risk factors, treatment of comorbid conditions, the use of bronchodilator therapy with long-acting β2-agonists or long-acting muscarinic antagonists, and inhaled corticosteroids. A better understanding of the mechanisms underlying COPD exacerbations will help to optimize use of the currently available and new interventions for preventing and treating exacerbations.

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Biomarkers and clinical outcomes in COPD: a systematic review and meta-analysis

Jilles M Fermont, Katya L Masconi, Magnus T Jensen … (2019)

Background Conventional measures to evaluate COPD may fail to capture systemic problems, particularly musculoskeletal weakness and cardiovascular disease. Identifying these manifestations and assessing their association with clinical outcomes (ie, mortality, exacerbation and COPD hospital admission) is of increasing clinical importance. Objective To assess associations between 6 min walk distance (6MWD), heart rate, fibrinogen, C reactive protein (CRP), white cell count (WCC), interleukins 6 and 8 (IL-6 and IL-8), tumour necrosis factor-alpha, quadriceps maximum voluntary contraction, sniff nasal inspiratory pressure, short physical performance battery, pulse wave velocity, carotid intima-media thickness and augmentation index and clinical outcomes in patients with stable COPD. Methods We systematically searched electronic databases (August 2018) and identified 61 studies, which were synthesised, including meta-analyses to estimate pooled HRs, following Meta-analysis of Observational Studies in Epidemiology (MOOSE) and Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. Results Shorter 6MWD and elevated heart rate, fibrinogen, CRP and WCC were associated with higher risk of mortality. Pooled HRs were 0.80 (95% CI 0.73 to 0.89) per 50 m longer 6MWD, 1.10 (95% CI 1.02 to 1.18) per 10 bpm higher heart rate, 3.13 (95% CI 2.14 to 4.57) per twofold increase in fibrinogen, 1.17 (95% CI 1.06 to 1.28) per twofold increase in CRP and 2.07 (95% CI 1.29 to 3.31) per twofold increase in WCC. Shorter 6MWD and elevated fibrinogen and CRP were associated with exacerbation, and shorter 6MWD, higher heart rate, CRP and IL-6 were associated with hospitalisation. Few studies examined associations with musculoskeletal measures. Conclusion Findings suggest 6MWD, heart rate, CRP, fibrinogen and WCC are associated with clinical outcomes in patients with stable COPD. Use of musculoskeletal measures to assess outcomes in patients with COPD requires further investigation. Trial registration number CRD42016052075.

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Bronchoscopic validation of the significance of sputum purulence in severe exacerbations of chronic obstructive pulmonary disease.

Nestor Soler, Joaquim Angrill, Antoni Torres … (2006)

Antibiotics are commonly prescribed in exacerbations of chronic obstructive pulmonary disease (COPD). However, the role of bacteria in these exacerbations is controversial. To identify clinical predictors of bacterial infection as a cause of exacerbation, considering the protected specimen brush (PSB) as the gold standard. Clinical data, sputum and PSB samples were collected from 40 patients with COPD requiring hospitalisation due to severe exacerbations who had not received previous antibiotic treatment. Quantitative cultures of PSB samples (n = 40) yielded 23 potential pathogenic microorganisms (PPMs) at concentrations of > or =10(2) colony-forming units/ml in 18 (45%) patients. Sputum samples were obtained from all 40 patients. Culture of good-quality sputum samples (n = 18) yielded 16 PPMs corresponding to 14 (35%) patients. The concordance between the PSB and sputum rate was high (kappa = 0.85, p 4 exacerbations in the past year (OR 6.9 (95% CI 0.08 to 1.08), p = 0.028) and previous hospitalisations due to COPD (OR 4.13 (95% CI 1.02 to 16.07), p = 0.041) were associated with the presence of PPMs in the distal airways. The operative characteristics for predicting distal airway infection when patients presented with purulent exacerbation were as follows: sensitivity 89.5%, specificity 76.2%, positive predicted value 77.3% and negative predicted value 88.9%. The self-reporting presence of purulence in the sputum, as well as common previous exacerbations and hospitalisations due to COPD in patients with severe airflow obstruction (FEV1% <50) predict the presence of bacterial infection in the distal airways. The use of these clinical variables may help in selecting candidates to receive antibiotic treatment.

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Author and article information

Journal

Journal ID (nlm-ta): BMJ Open

Journal ID (iso-abbrev): BMJ Open

Journal ID (hwp): bmjopen

Journal ID (publisher-id): bmjopen

Title: BMJ Open

Publisher: BMJ Publishing Group (BMA House, Tavistock Square, London, WC1H 9JR )

ISSN (Electronic): 2044-6055

Publication date Collection: 2019

Publication date (Electronic): 28 November 2019

Volume: 9

Issue: 11

Electronic Location Identifier: e030249

Affiliations

[1 ] departmentDepartment of Graduate School , Beijing University of Chinese Medicine , Beijing, China

[2 ] departmentDepartment of TCM Pulmonary Diseases, Center of Respiratory Medicine , China-Japan Friendship Hospital; National Clinical Research Center for Respiratory Diseases , Beijing, China

[3 ] departmentDepartment of TCM Pulmonary Diseases , China-Japan Friendship Hospital , Beijing, China

[4 ] departmentDepartment of Pulmonary disease , Wangjing Hospital of China Academy of Chinese Medical Sciences , Beijing, China

[5 ] departmentHospital Management Office , Tianjin University of Traditional Chinese Medicine , Tianjin, China

[6 ] departmentDepartment of Pulmonary disease , Affiliated Hospital of Tianjin University of TCM , Tianjin, China

[7 ] departmentDepartment of Innovation and Transformation , National Center for Traditional Chinese Medicine, State Administration of Traditional Chinese Medicine of the People’s Republic of China , Beijing, China

[8 ] departmentDepartment of Medical Science Services , Beijing Qihuang Medicine Clinical Research Center , Beijing, China

[9 ] departmentDepartment of Pulmonary Medicine , Zhongshan Hospital Fudan University , Shanghai, China

[10 ] departmentDepartment of Pulmonary disease , Shanghai Jiao Tong University Medical School Affiliated Ruijin Hospital , Shanghai, China

[11 ] departmentDepartment of Respiratory and Critical Care Medicine , China Medical University First Hospital , Shenyang, China

Author notes

[Correspondence to ] Professor Hongchun Zhang; 13701226664@ 123456139.com

Article

Publisher ID: bmjopen-2019-030249

DOI: 10.1136/bmjopen-2019-030249

PMC ID: 6924718

PubMed ID: 31784433

SO-VID: 757a53fa-adb9-43dd-a907-fc62bfd75c02

License:

This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.

History

Date received : 11 March 2019

Date revision received : 17 September 2019

Date accepted : 23 September 2019

Funding

Funded by: National Key Research and Development Program of China;

Award ID: 2017YFC1309305

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ScienceOpen disciplines: Medicine

Keywords: acute exacerbation of chronic obstructive pulmonary disease,comparative effectiveness research,traditional chinese medicine

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ScienceOpen disciplines: Medicine

Keywords: acute exacerbation of chronic obstructive pulmonary disease, comparative effectiveness research, traditional chinese medicine

Effectiveness of Xin Jia Xuan Bai Cheng Qi Decoction in treating acute exacerbation of chronic obstructive pulmonary disease: study protocol for a multicentre, randomised, controlled trial

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Abstract

Introduction

Methods and analysis

Ethics and dissemination

Trial registration number

Related collections

Network Medicine

Most cited references 17

Exacerbations of COPD

Biomarkers and clinical outcomes in COPD: a systematic review and meta-analysis

Bronchoscopic validation of the significance of sputum purulence in severe exacerbations of chronic obstructive pulmonary disease.

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