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| Literature characteristics and outcome lndicators of randomized controlled trials of oral traditional Chinese medicine in treatment of bronchiectasis |
| Hits 301 Download times 105 Received:July 03, 2025 |
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| DOI
10.11656/j.issn.1672-1519.2025.11.10 |
| Key Words
oral Chinese medicine;bronchiectasis;randomized controlled trial;study design;outcome indicator |
| Author Name | Affiliation | E-mail | | WANG Xiaoyu | Department of Respiratory Diseases, The First Affiliated Hospital of Henan University of Chinese Medicine, Zhengzhou 450003, China
The First Clinical Medical School, Henan University of Chinese Medicine, Zhengzhou 450003, China | | | FENG Zhenzhen | Department of Respiratory Diseases, The First Affiliated Hospital of Henan University of Chinese Medicine, Zhengzhou 450003, China
The First Clinical Medical School, Henan University of Chinese Medicine, Zhengzhou 450003, China
Collaborative Innovation Center for Chinese Medicine and Respiratory Diseases Co-constructed by Henan Province & Education Ministry of P. R. China/Henan Key Laboratory of Chinese Medicine for Respiratory Diseases, Henan University of Chinese Medicine, Zhengzhou 450046, China | huxifzz@163.com | | WANG Lu | Department of Respiratory Diseases, The First Affiliated Hospital of Henan University of Chinese Medicine, Zhengzhou 450003, China
The First Clinical Medical School, Henan University of Chinese Medicine, Zhengzhou 450003, China | | | ZHAO Guixiang | Department of Respiratory Diseases, The First Affiliated Hospital of Henan University of Chinese Medicine, Zhengzhou 450003, China
The First Clinical Medical School, Henan University of Chinese Medicine, Zhengzhou 450003, China | | | WEI Mengyu | Department of Respiratory Diseases, The First Affiliated Hospital of Henan University of Chinese Medicine, Zhengzhou 450003, China
The First Clinical Medical School, Henan University of Chinese Medicine, Zhengzhou 450003, China | | | LI Jiansheng | Department of Respiratory Diseases, The First Affiliated Hospital of Henan University of Chinese Medicine, Zhengzhou 450003, China
The First Clinical Medical School, Henan University of Chinese Medicine, Zhengzhou 450003, China
Collaborative Innovation Center for Chinese Medicine and Respiratory Diseases Co-constructed by Henan Province & Education Ministry of P. R. China/Henan Key Laboratory of Chinese Medicine for Respiratory Diseases, Henan University of Chinese Medicine, Zhengzhou 450046, China | |
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| Abstract
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| [Objective] To systematically review the literature characteristics and outcome indicators of randomized controlled trial（RCT） of oral traditional Chinese medicine（TCM） in the treatment of bronchiectasis，so as to provide a reference for improving the quality of clinical research and constructing the core index set. [Methods] PubMed，Embase，Cochrane Library，Web of Science，CNKI，Wanfang Database，VIP and SinoMed were searched for RCTs of TCM in the treatment of bronchiectasis，and the retrieval time between January 1st 2019 and July 31st 2024，then extract the basic information，literature characteristics，outcome indicators and so on to analyse. [Results] A total of 117 studies involving 9 733 patients were included. 1 study is multicenter，potion is the most commonly dosage form，course of treatment focused on eight days to two weeks，15 studies refer to follow-up，94 studies report patients’ TCM syndrome. In the risk of bias assessment，randomized sequence generation，outcome data integrity，and selective reporting were mostly rated as “low risk”，and the rest were “unclear”. A total of 106 outcome indicators were obtained，which could be classified into 9 indicator domains. The total frequency of reporting was 889 times，and the top 10 indicators were：effective rate，adverse reactions，forced expiratory volume in the first second（FEV1），TCM syndrome score，C-reactive protein（CRP），white blood cell count，forced vital capacity（FVC），FEV1/FVC，procalcitonin（PCT），TCM symptom score. [Conclusion] Nearly five years of RCTs of oral TCM in the treatment of bronchiectasis have mang problems such as cases of typical difference，short course of treatment and low follow-up rate，different reference standards，nonstandard application outcome indicators in study design and outcome indicators report. The future still needs more high-quality RCTs，at the same time to build the core indicators set，in order to improve the quality of evidence-based evidence of TCM. |
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