AUTHOR=Shu Xinyang , Xu Dongfeng , Qu Yumin , Shang Xiaofeng , Qiao Kehong , Feng Cuiling , Cui Hongsheng , Zhao Xianping , Li Yuxin , Peng Yu , Li Demin , Zhang Hongchun 

TITLE=Efficacy and safety of Cordyceps sinensis (Hirsutella sinensis, Cs-C-Q80) in chronic bronchitis

JOURNAL=Frontiers in Pharmacology

VOLUME=15

YEAR=2024

URL=https://www.frontiersin.org/journals/pharmacology/articles/10.3389/fphar.2024.1428216

DOI=10.3389/fphar.2024.1428216

ISSN=1663-9812

ABSTRACT=<p><bold>Background:</bold><italic>Cordyceps sinensis</italic> is a traditional Chinese medicine that has shown promise for the management of chronic bronchitis (CB). We aim to assess the efficacy and safety of a preparation of <italic>C sinensis</italic> named Bailing capsule (<italic>Hirsutella sinensis</italic>, Cs-C-Q80) compared with a placebo in patients with CB.</p><p><bold>Methods:</bold> This randomized, double-blind, placebo-controlled, parallel-group clinical trial (Chinese Clinical Trial Registry; registration number: ChiCTR1900025707) recruited patients with CB from eight hospitals in China between May 2019 and December 2020. Patients were randomized 2:1 to receive Bailing capsule or a placebo orally for 48 weeks (2.0 g, three times a day).</p><p><bold>Results:</bold> Among 240 patients who were randomized, 238 (Bailing capsule: 159, placebo: 79) were included in the primary analysis. Bailing capsule significantly reduced the frequency of acute exacerbation of CB (AECB) compared with the placebo during treatment (0.43 ± 0.82 vs. 1.56 ± 1.34; <italic>P</italic> &lt; 0.001) and follow-up (0.21 ± 0.64 vs. 0.45 ± 0.93; <italic>P</italic> = 0.026). Bailing capsule improved the severity of expectoration (<italic>P</italic> = 0.046) and wheezing (<italic>P</italic> = 0.010) in AECB during follow-up. The severity of CB after treatment was significantly improved in the Bailing capsule group compared with the placebo group (<italic>P</italic> = 0.035), particularly in terms of expectoration (<italic>P</italic> = 0.012) and wheezing (<italic>P</italic> = 0.003). The risk of adverse events, mainly including infectious and invasive diseases and gastrointestinal symptoms, did not significantly differ between the two groups (29.6% vs. 30.4%).</p><p><bold>Conclusion:</bold> In patients with CB, Bailing capsule significantly reduces the frequency of AECB and ameliorates the severity of AECB and CB symptoms.</p><p><bold>Clinical Trail Registration:</bold><ext-link ext-link-type="uri" xlink:href="https://www.chictr.org.cn" xmlns:xlink="http://www.w3.org/1999/xlink">https://www.chictr.org.cn</ext-link>, identifer ChiCTR1900025707.</p>