Abstract
BackgroundCommunity-acquired pneumonia, especially severe community-acquired pneumonia (SCAP), remains the leading cause of death in the world. Despite advances in antimicrobial therapy, the mortality rates due to SCAP have not decreased significantly since antibiotics became routinely available. Traditional Chinese medicine (TCM) has been used for treating pneumonia for thousands of years. It is popular and widely practiced in Asia. In recent decades, evidence from both clinicians and patients suggests that TCM has some beneficial effect on SCAP. Thus, this study aims to compare the efficacy of a combination of a conventional drug and TCM to the conventional drug alone, to provide a scientific basis for clinical decisions.Methods/designA prospective, multi-center, single-blinded, double-dummy, and randomized controlled clinical trial is being conducted to test the therapeutic effects of a combination of conventional medicine and TCM versus conventional medicine in the treatment of SCAP. A total of 198 patients will be enrolled in this study, with 99 in each treatment group (combination group or conventional medicine group). The TCM will be administered twice daily for 28 days. All patients will be followed for 3 months. The primary outcome measure is treatment failure, which is defined as clinical deterioration. Secondary outcome measures are time to clinical stability, length of hospital stay, in-hospital mortality, SOFA questionnaire, quality of life and cost of treatment.DiscussionIt is hypothesized that the combination of a conventional drug and TCM will reduce treatment failure, time to clinical stability, length hospital of stays, and in-hospital mortality, and improve the quality of life of SCAP patients.Trial registrationClinicalTrials.gov, NCT03185923. Registered on 20 June 2017.
Highlights
Community-acquired pneumonia, especially severe community-acquired pneumonia (SCAP), remains the leading cause of death in the world
It is hypothesized that the combination of a conventional drug and Traditional Chinese medicine (TCM) will reduce treatment failure, time to clinical stability, length hospital of stays, and in-hospital mortality, and improve the quality of life of SCAP patients
TCM have been used for thousands of years in China for treating pneumonia, and it is widely used in many countries
Summary
Community-acquired pneumonia, especially severe community-acquired pneumonia (SCAP), remains the leading cause of death in the world. Despite advances in antimicrobial therapy, the mortality rates due to SCAP have not decreased significantly since antibiotics became routinely available. Traditional Chinese medicine (TCM) has been used for treating pneumonia for thousands of years. It is popular and widely practiced in Asia. Despite advances in antibiotic treatment, mortality among hospitalized patients with CAP is still high, especially in those with severe pneumonia [3] and in those who experience treatment failure [4]. Many different organizations have worked to improve the care of patients with CAP Such efforts are warranted, because CAP, especially severe community-acquired pneumonia (SCAP), remains the leading cause of death globally. Despite advances in antimicrobial therapy, mortality rates due to SCAP have not decreased significantly since penicillin became routinely available
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