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      Effects of Chinese Herbal Medicine on Acute Exacerbations of COPD: A Randomized, Placebo-Controlled Study

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          Abstract

          Purpose

          Acute exacerbation of chronic obstructive pulmonary disease (AECOPD) is an essential occurrence in COPD management and is the leading cause of morbidity and mortality. Chinese herbal medicine is widely used in the treatment of AECOPD, but high quality randomized controlled trials are limited. This study aimed to evaluate the efficacy and safety of Chinese herbal medicine as adjuvant therapy for patients with AECOPD.

          Methods

          This was a randomized, double-blind, placebo-controlled study of 378 participants from eight centers in China. Participants were randomly assigned to receive 10 g of Chinese herbal medicine (according to the type of Traditional Chinese medicine syndrome: Sanhanhuayin, Qingrehuatan, or Zaoshihuatan granules) or placebo, two times per day, for 14 days, in addition to conventional medicine. Participants were followed up for 84 days after the treatment. The primary end point was the COPD assessment test (CAT) score. Secondary end points included the Modified British Medical Research Council (mMRC) questionnaire and the COPD patient-reported outcome scale (COPD-PRO). We also assessed treatment failure and treatment success rate, length of hospitalization, number of patients with acute exacerbations, number of patients readmitted due to AECOPD, and number of deaths and intubation.

          Results

          The between-group difference in the change from baseline for CAT on day 14 (end of treatment) was −2.11 (95% confidence interval [CI], −3.198 to −1.050; P<0.001), exceeding the minimal clinically important difference. The mMRC and COPD-PRO scores were lower in the intervention group compared to the control group (between-group difference in the change from baseline, −0.28; 95% CI, −0.48 to −0.08; P=0.007 and −2.51; 95% CI, −4.087 to −0.929; P=0.002, respectively) on day 14. The intervention group had a significantly shorter duration of hospital stay than the control group (mean difference, −1.21days; 95% CI, −2.041 to −0.419; P=0.003), significantly lower of number of exacerbations (risk ratio [RR], 0.60; 95% CI, 0.409 to 0.892; P=0.010), and significantly lower number of readmissions due to AECOPD (RR, 0.41; 95% CI, 0.193 to 0.865; P=0.015). Significant differences in the number of treatment failures or successes, deaths, and intubation were not observed. The difference in safety variables and adverse events between the two groups was not observed.

          Conclusion

          Chinese herbal medicine appears to be safe and beneficial for AECOPD and can be considered a complementary treatment for patients with AECOPD.

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          Most cited references 25

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          Global, regional, and national age–sex specific all-cause and cause-specific mortality for 240 causes of death, 1990–2013: a systematic analysis for the Global Burden of Disease Study 2013

          Up-to-date evidence on levels and trends for age-sex-specific all-cause and cause-specific mortality is essential for the formation of global, regional, and national health policies. In the Global Burden of Disease Study 2013 (GBD 2013) we estimated yearly deaths for 188 countries between 1990, and 2013. We used the results to assess whether there is epidemiological convergence across countries. We estimated age-sex-specific all-cause mortality using the GBD 2010 methods with some refinements to improve accuracy applied to an updated database of vital registration, survey, and census data. We generally estimated cause of death as in the GBD 2010. Key improvements included the addition of more recent vital registration data for 72 countries, an updated verbal autopsy literature review, two new and detailed data systems for China, and more detail for Mexico, UK, Turkey, and Russia. We improved statistical models for garbage code redistribution. We used six different modelling strategies across the 240 causes; cause of death ensemble modelling (CODEm) was the dominant strategy for causes with sufficient information. Trends for Alzheimer's disease and other dementias were informed by meta-regression of prevalence studies. For pathogen-specific causes of diarrhoea and lower respiratory infections we used a counterfactual approach. We computed two measures of convergence (inequality) across countries: the average relative difference across all pairs of countries (Gini coefficient) and the average absolute difference across countries. To summarise broad findings, we used multiple decrement life-tables to decompose probabilities of death from birth to exact age 15 years, from exact age 15 years to exact age 50 years, and from exact age 50 years to exact age 75 years, and life expectancy at birth into major causes. For all quantities reported, we computed 95% uncertainty intervals (UIs). We constrained cause-specific fractions within each age-sex-country-year group to sum to all-cause mortality based on draws from the uncertainty distributions. Global life expectancy for both sexes increased from 65.3 years (UI 65.0-65.6) in 1990, to 71.5 years (UI 71.0-71.9) in 2013, while the number of deaths increased from 47.5 million (UI 46.8-48.2) to 54.9 million (UI 53.6-56.3) over the same interval. Global progress masked variation by age and sex: for children, average absolute differences between countries decreased but relative differences increased. For women aged 25-39 years and older than 75 years and for men aged 20-49 years and 65 years and older, both absolute and relative differences increased. Decomposition of global and regional life expectancy showed the prominent role of reductions in age-standardised death rates for cardiovascular diseases and cancers in high-income regions, and reductions in child deaths from diarrhoea, lower respiratory infections, and neonatal causes in low-income regions. HIV/AIDS reduced life expectancy in southern sub-Saharan Africa. For most communicable causes of death both numbers of deaths and age-standardised death rates fell whereas for most non-communicable causes, demographic shifts have increased numbers of deaths but decreased age-standardised death rates. Global deaths from injury increased by 10.7%, from 4.3 million deaths in 1990 to 4.8 million in 2013; but age-standardised rates declined over the same period by 21%. For some causes of more than 100,000 deaths per year in 2013, age-standardised death rates increased between 1990 and 2013, including HIV/AIDS, pancreatic cancer, atrial fibrillation and flutter, drug use disorders, diabetes, chronic kidney disease, and sickle-cell anaemias. Diarrhoeal diseases, lower respiratory infections, neonatal causes, and malaria are still in the top five causes of death in children younger than 5 years. The most important pathogens are rotavirus for diarrhoea and pneumococcus for lower respiratory infections. Country-specific probabilities of death over three phases of life were substantially varied between and within regions. For most countries, the general pattern of reductions in age-sex specific mortality has been associated with a progressive shift towards a larger share of the remaining deaths caused by non-communicable disease and injuries. Assessing epidemiological convergence across countries depends on whether an absolute or relative measure of inequality is used. Nevertheless, age-standardised death rates for seven substantial causes are increasing, suggesting the potential for reversals in some countries. Important gaps exist in the empirical data for cause of death estimates for some countries; for example, no national data for India are available for the past decade. Bill & Melinda Gates Foundation. Copyright © 2015 Elsevier Ltd. All rights reserved.
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            Economic Burden of COPD in the Presence of Comorbidities

            BACKGROUND: The morbidity and mortality associated with COPD exacts a considerable economic burden. Comorbidities in COPD are associated with poor health outcomes and increased costs. Our objective was to assess the impact of comorbidities on COPD-associated costs in a large administrative claims dataset. METHODS: This was a retrospective observational study of data from the Truven Health MarketScan Commercial Claims and Encounters and the MarketScan Medicare Supplemental Databases from January 1, 2009, to September 30, 2012. Resource consumption was measured from the index date (date of first occurrence of non-rule-out COPD diagnosis) to 360 days after the index date. Resource use (all-cause and disease-specific [ie, COPD- or asthma-related] ED visits, hospitalizations, office visits, other outpatient visits, and total length of hospital stay) and health-care costs (all-cause and disease-specific costs for ED visits, hospitalizations, office visits, and other outpatient visits and medical, prescription, and total health-care costs) were assessed. Generalized linear models were used to evaluate the impact of comorbidities on total health-care costs, adjusting for age, sex, geographic location, baseline health-care use, employment status, and index COPD medication. RESULTS: Among 183,681 patients with COPD, the most common comorbidities were cardiovascular disease (34.8%), diabetes (22.8%), asthma (14.7%), and anemia (14.2%). Most patients (52.8%) had one or two comorbidities of interest. The average all-cause total health-care costs from the index date to 360 days after the index date were highest for patients with chronic kidney disease ($41,288) and anemia ($38,870). The impact on total health-care costs was greatest for anemia ($10,762 more, on average, than a patient with COPD without anemia). CONCLUSIONS: Our analysis demonstrated that high resource use and costs were associated with COPD and multiple comorbidities.
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              Health status assessment in routine clinical practice: the chronic obstructive pulmonary disease assessment test score in outpatients.

              The chronic obstructive pulmonary disease (COPD) assessment test (CAT) is a simple, self-completion questionnaire developed to measure health status in patients with COPD, which is potentially suitable for routine clinical use. The purpose of this study was to establish the determinants of the CAT score in routine clinical practice. Patients attending the clinic completed the CAT score before being seen. Clinical data, including, where available, plethysmographic lung volumes, transfer factor and arterial blood gas analysis, were recorded on a pro forma in the clinic. In 224 patients (36% female), mean forced expiratory volume in 1 s (FEV₁) was 40.1% (17.9) of predicted (%pred); CAT score was associated with exacerbation frequency [0-1/year 20.1 (7.6); 2-4/year 23.5 (7.8); >4/year 28.5 (7.3), p < 0.0001; 41/40/19% in each category] and with Medical Research Council (MRC) dyspnoea score (r² = 0.26, p < 0.0001) rising approximately 4 points with each grade. FEV(1) %pred had only a weak influence. Using stepwise regression, CAT score = 2.48 + 4.12 [MRC (1-5) dyspnoea score] + 0.08 (FEV(1) %pred) + 1.06 (exacerbation rate/year)] (r² = 0.36, p < 0.0001). The CAT score was higher in patients (n = 54) with daily sputum production [25.9 (7.5) vs. 22.2 (8.2); p = 0.004]. Detailed lung function (plethysmography and gas transfer) was available in 151 patients but had little influence on the CAT score. The CAT score is associated with clinically important variables in patients with COPD and enables health status measurement to be performed in routine clinical practice. Copyright © 2012 S. Karger AG, Basel.
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                Author and article information

                Journal
                Int J Chron Obstruct Pulmon Dis
                Int J Chron Obstruct Pulmon Dis
                copd
                copd
                International Journal of Chronic Obstructive Pulmonary Disease
                Dove
                1176-9106
                1178-2005
                12 November 2020
                2020
                : 15
                : 2901-2912
                Affiliations
                [1 ]Co-Construction Collaborative Innovation Center for Chinese Medicine and Respiratory Diseases by Henan & Education Ministry of P.R. China, Henan University of Chinese Medicine , Zhengzhou, People’s Republic of China
                [2 ]Henan Key Laboratory of Chinese Medicine for Respiratory Disease, Henan University of Chinese Medicine , Zhengzhou, People’s Republic of China
                [3 ]The First Affiliated Hospital of Henan University of Chinese Medicine , Zhengzhou, People’s Republic of China
                [4 ]Jiangsu Province Hospital of Traditional Chinese Medicine , Nanjing, People’s Republic of China
                [5 ]The First Affiliated Hospital of Zhengzhou University , Zhengzhou, People’s Republic of China
                [6 ]The Second Affiliated Hospital of Tianjin University of Traditional Chinese Medicine , Tianjin, People’s Republic of China
                [7 ]Haici Hospital of Qingdao , Qingdao, People’s Republic of China
                [8 ]Zhengzhou People’s Hospital , Zhengzhou, People’s Republic of China
                [9 ]Shanxi Hospital of Integrated Traditional and Western Medicine , Taiyuan, People’s Republic of China
                [10 ]Nanyang City Center Hospital , Nanyang, People’s Republic of China
                Author notes
                Correspondence: Jiansheng Li No. 156 Jinshui East Road, Zhengdong New District, Zhengzhou, Henan450046, People’s Republic of ChinaTel +86 371 65676568Fax +86 371 65944307 Email li_js8@163.com
                [*]

                These authors contributed equally to this work

                Article
                276082
                10.2147/COPD.S276082
                7670171
                33209019
                © 2020 Li et al.

                This work is published and licensed by Dove Medical Press Limited. The full terms of this license are available at https://www.dovepress.com/terms.php and incorporate the Creative Commons Attribution – Non Commercial (unported, v3.0) License ( http://creativecommons.org/licenses/by-nc/3.0/). By accessing the work you hereby accept the Terms. Non-commercial uses of the work are permitted without any further permission from Dove Medical Press Limited, provided the work is properly attributed. For permission for commercial use of this work, please see paragraphs 4.2 and 5 of our Terms ( https://www.dovepress.com/terms.php).

                Page count
                Figures: 1, Tables: 7, References: 27, Pages: 12
                Funding
                Funded by: National Natural Science Foundation of China, open-funder-registry 10.13039/501100001809;
                This study was supported by the National Natural Science Foundation of China (Grant No. 81973781, 81603556) and the construction project of the characteristic discipline of Chinese medicine in Henan province, China (Grant No. STS-ZYX- 2017006).
                Categories
                Clinical Trial Report

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