Effects of Chinese medicine on patients with acute exacerbations of COPD: study protocol for a randomized controlled trial

Hailong Zhang, Jiansheng Li, Xueqing Yu, Suyun Li, Haifeng Wang, Huanrong Ruan, Yimei Si, Yang Xie, Minghang Wang, Hailong Zhang, Jiansheng Li, Xueqing Yu, Suyun Li, Haifeng Wang, Huanrong Ruan, Yimei Si, Yang Xie, Minghang Wang

Abstract

Background: The incidence, mortality, and prevalence of chronic obstructive pulmonary disease (COPD) are high in China. Acute exacerbations of COPD (AECOPD) are important events in the management of COPD because they negatively impact health status, rates of hospitalization and readmission, and disease progression. AECOPD have been effectively treated with Chinese medicine for a long time. The aim of this proposed trial is to assess the therapeutic effect of Chinese medicine (CM) on AECOPD.

Methods/design: This proposed study is a multicenter, double-blind, parallel-group randomized controlled trial (RCT). We will randomly assign 378 participants with AECOPD into two groups in a 1:1 ratio. On the basis of health education and conventional treatment, the intervention group will be treated with CM, and the control group is given CM placebo according to CM syndrome. Patients are randomized to either receive CM or placebo, 10 g/packet, twice daily. The double-blind treatment lasts for 2 weeks and is followed up for 4 weeks. The main outcome is the COPD Assessment Test; secondary outcomes are treatment failure rate, treatment success rate, length of hospital stay, AECOPD readmission rate, intubation rate, mortality, dyspnea, the 36-item Short Form Health Survey, and the COPD patient-reported outcome scale. We will document these outcomes faithfully at the beginning of the study, 2 weeks after treatment, and at the 4 weeks follow-up.

Discussion: This high-quality RCT with strict methodology and few design deficits will help to prove the effectiveness of CM for AECOPD. We hope this trial will provide useful evidence for developing a therapeutic schedule with CM for patients with AECOPD.

Trial registration: ClinicalTrials.gov, NCT03428412. Registered on 4 February 2018.

Keywords: Acute exacerbations; COPD; Chinese medicine; Randomized controlled trial.

Conflict of interest statement

The authors declare that they have no competing interests.

Figures

Fig. 1
Fig. 1
Flowchart for the intervention trial

References

    1. Lozano R, Naghavi M, Foreman K, et al. Global and regional mortality from 235 causes of death for 20 age groups in 1990 and 2010: a systematic analysis for the Global Burden of Disease Study 2010. Lancet. 2012;380(9859):2095–2128. doi: 10.1016/S0140-6736(12)61728-0.
    1. Global strategy for the diagnosis, management and prevention of COPD. Global Initiative for Chronic Obstructive Lung Disease (GOLD); 2018. . Accessed on 1 Nov 2017.
    1. Yin P, Wang H, Vos T, et al. A subnational analysis of mortality and prevalence of COPD in China from 1990 to 2013: findings from the Global Burden of Disease Study 2013. Chest. 2016;150(6):1269–1280. doi: 10.1016/j.chest.2016.08.1474.
    1. Perera PN, Armstrong EP, Sherrill DL, et al. Acute exacerbations of COPD in the United States: inpatient burden and predictors of costs and mortality. COPD. 2012;9(2):131–141. doi: 10.3109/15412555.2011.650239.
    1. Chen YH, Yao WZ, Cai BQ, et al. Economic analysis in admitted patients with acute exacerbation of chronic obstructive pulmonary disease. Chin Med J. 2008;121(7):587–591. doi: 10.1097/00029330-200804010-00003.
    1. Zhang H, Wang M, F L, et al. Systematic review of therapeutic effect assessment index of randomized controlled trials on acute exacerbation of chronic obstructive pulmonary disease by Chinese medicine syndrome differentiation and treatment. China J Chin Med. 2013;28(6):797–804.
    1. Chan AW, Tetzlaff JM, Altman DG, Laupacis A, Gøtzsche PC, Krleža-Jerić K, et al. SPIRIT 2013 statement: defining standard protocol items for clinical trials. Ann Intern Med. 2013;158(3):200–207. doi: 10.7326/0003-4819-158-3-201302050-00583.
    1. Jiansheng L, Haifeng W, Suyun L, Hailong Z, Xueqing Y, Xiaoyun Z, et al. Effect of sequential treatment with TCM syndrome differentiation on acute exacerbation of chronic obstructive pulmonary disease and AECOPD risk window. Complement Ther Med. 2016;29:109–115. doi: 10.1016/j.ctim.2016.09.009.
    1. Kon SS, Canavan JL, Jones SE, Nolan CM, Clark AL, Dickson MJ, et al. Minimum clinically important difference for the COPD Assessment Test: a prospective analysis. Lancet Respir Med. 2014;2(3):195–203. doi: 10.1016/S2213-2600(14)70001-3.
    1. Jones PW, Harding G, Wiklund I. Improving the process and outcome of care in COPD: development of a standardised assessment tool. Prim Care Respir J. 2009;18:208–215. doi: 10.4104/pcrj.2009.00053.
    1. Jones PW, Harding G, Berry P, Wiklund I, Chen WH, Kline Leidy NK. Development and first validation of the COPD assessment test. Eur Respir J. 2009;34(3):648–654. doi: 10.1183/09031936.00102509.
    1. CAT development steering group: COPD assessment test-healthcare professional user guide. Issue 3: February 2012. . Accessed 16 Apr 2014.
    1. Mackay AJ, Donaldson GC, Patel AR, et al. Utility of The COPD Assessment Test (CAT) to evaluate severity of COPD exacerbations. Am J Respiratory Critical Care Med. 2012;185:A1513. doi: 10.1164/rccm.201110-1843OC.
    1. Tu YH, Zhang Y, Fei GH. Utility of the CAT in the therapy assessment of COPD exacerbations in China. BMC Pulm Med. 2014;14:42. doi: 10.1186/1471-2466-14-42.
    1. Chow AW, Hall CB, Klein JO, Kammer RB, Meyer RD, Remington JS. Evaluation of new anti-infective drugs for the treatment of respiratory tract infections. Infectious Diseases Society of America and the Food and Drug Administration. Clin Infect Dis. 1992;15(Suppl 1):S62–S88. doi: 10.1093/clind/15.Supplement_1.S62.
    1. Fletcher CM. Standardised questionnaire on respiratory symptoms: a statement prepared and approved by the MRC Committee on the Aetiology of Chronic Bronchitis (MRC breathlessness score) BMJ. 1960;2:1662.
    1. Bestall JC, Paul EA, Garrod R, Garnham R, Jones PW, Wedzicha JA. Usefulness of the Medical Research Council (MRC) dyspnoea scale as a measure of disability in patients with chronic obstructive pulmonary disease. Thorax. 1999;54(7):581–586. doi: 10.1136/thx.54.7.581.
    1. Sundh J, Janson C, Lisspers K, Stallberg B, Montgomery S. The Dyspnoea, Obstruction, Smoking, Exacerbation (DOSE) index is predictive of mortality in COPD. Prim Care Respir J. 2012;21(3):295–301. doi: 10.4104/pcrj.2012.00054.
    1. Li L, Wang HM, Shen Y. Chinese SF-36 Health Survey: translation, cultural adaptation, validation, and normalization. J Epidemiol Community Health. 2003;57(4):259–263. doi: 10.1136/jech.57.4.259.
    1. Li JS, Wang MH, Yu XQ, Li SY, Xie Y. Development and validation of a patient reported outcome instrument for chronic obstructive pulmonary diseases. Chin J Integr Med. 2015;21(9):667–675. doi: 10.1007/s11655-014-1982-4.
    1. Julia YLIN, Ying LU. Establishing a data monitoring committee for clinical trials. Shanghai Arch Psychiatry. 2014;26(01):54–56.
    1. Pitta F, Troosters T, Probst VS, Spruit MA, Decramer M, Gosselink R. Physical activity and hospitalization for exacerbation of COPD. Chest. 2006;129(3):536–544. doi: 10.1378/chest.129.3.536.
    1. Garcia-Aymerich J, Farrero E, Félez MA, Izquierdo J, Marrades RM, Antó JM. Risk factors of readmission to hospital for a COPD exacerbation: a prospective study. Thorax. 2003;58(2):100–105. doi: 10.1136/thorax.58.2.100.
    1. Liu M, Zhong X, Li Y, Zheng F, Wu R, Sun Y, Zhang J. Xuan Bai Cheng Qi formula as an adjuvant treatment of acute exacerbation of chronic obstructive pulmonary disease of the syndrome type phlegm-heat obstructing the lungs: a multicenter, randomized, double-blind, placebo-controlled clinical trial. BMC Complement Altern Med. 2014;14:239. doi: 10.1186/1472-6882-14-239.
    1. Anthonisen NR, Manfreda J, Warren CP, Hershfield ES, Harding GK, Nelson NA. Antibiotic therapy in exacerbations of chronic obstructive pulmonary disease. Ann Intern Med. 1987;106(2):196–204. doi: 10.7326/0003-4819-106-2-196.

Source: PubMed

赞助者和合作者

医疗条件

药物干预

3
订阅