Abstract
BackgroundThe 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/designThis 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.DiscussionThis 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 registrationClinicalTrials.gov, NCT03428412. Registered on 4 February 2018.
Highlights
The incidence, mortality, and prevalence of chronic obstructive pulmonary disease (COPD) are high in China
This high-quality randomized controlled trial (RCT) with strict methodology and few design deficits will help to prove the effectiveness of Chinese medicine (CM) for Acute exacerbations of COPD (AECOPD)
The goals of treatment for AECOPD are to minimize the negative impact of the current exacerbation and prevent the development of subsequent events
Summary
AECOPD are important events in the management of COPD because they negatively impact health status and rates of hospitalization and readmission, and potentially result in death and functional disability [22, 23]. Due to the single type of syndrome, limited sample sizes, or methodological problems apparent in some studies, the evidence for the effectiveness of CM was not robust This RCT will investigate the effectiveness of CM in the treatment of AECOPD. We examine the incidence of treatment failure and intubation, length of hospital stays, readmission due to exacerbation, number of deaths, and quality of life to obtain more evidence for AECOPD with CM. We hope this trial will provide useful evidence for developing a therapeutic schedule with CM for patients with AECOPD. A populated SPIRIT checklist is available as Additional file 1
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