Efficacy and safety of traditional Chinese medicine treatment for idiopathic pulmonary fibrosis: An exploratory, randomized, double-blinded and placebo controlled trial
Background and objective: Idiopathic pulmonary fibrosis (IPF) is a critical disease, with limited treatments available. Clinical practices show that traditional Chinese medicine (TCM) has certain efficacy. This study was preliminarily to evaluate the efficacy and safety of TCM treatment based on syn...
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Frontiers Media S.A.
2022-10-01
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| Series: | Frontiers in Pharmacology |
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| Online Access: | https://www.frontiersin.org/articles/10.3389/fphar.2022.1053356/full |
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| author | Jiansheng Li Jiansheng Li Jiansheng Li Xue-qing Yu Xue-qing Yu Xue-qing Yu Yang Xie Yang Xie Yang Xie Shu-guang Yang Shu-guang Yang Shu-guang Yang Limin Zhao Miao Zhou Yong Meng |
| author_facet | Jiansheng Li Jiansheng Li Jiansheng Li Xue-qing Yu Xue-qing Yu Xue-qing Yu Yang Xie Yang Xie Yang Xie Shu-guang Yang Shu-guang Yang Shu-guang Yang Limin Zhao Miao Zhou Yong Meng |
| author_sort | Jiansheng Li |
| collection | DOAJ |
| description | Background and objective: Idiopathic pulmonary fibrosis (IPF) is a critical disease, with limited treatments available. Clinical practices show that traditional Chinese medicine (TCM) has certain efficacy. This study was preliminarily to evaluate the efficacy and safety of TCM treatment based on syndrome differentiation in IPF.Methods: A study design of exploratory, multi-centers, randomized, double-blinded, placebo controlled trial has been adopted. A total of 80 IPF patients from four sub-centers were enrolled. All the patients were randomly assigned into TCM group (TCMG) or control group (CG) in 1:1. Patients in TCMG were given CM granules, as patients in CG given with the placebo of CM granule. All the patients received a 26-week treatment. The efficacy was assessed by acute exacerbations (AEs) of IPF, pulmonary function, clinical symptoms, dyspnea scores (mMRC), health-related quality of life (HRQoL), 6-min walk test (6MWT) and all-cause mortality. Safety has also been assessed.Results: A total of 67 patients completed the trial with 35 in TCM group and 32 in control group. Meaningful differences have been observed in mean changes in AEs (−1.56 times; 95% CI, −2.69 to −0.43, p = 0.01), DLco% (5.29; 95% CI, 0.76 to 9.81, p = 0.02), cough scores (−0.38 points; 95% CI, −0.73 to −0.04, p = 0.03), and 6MWT (30.43 m; 95% CI, 2.85 to 58.00, p = 0.03), with no statistical differences in FEV1, FVC, expectoration, chest tightness, Shortness of breath, Fatigue, Cyanosis, mMRC, CAT, SF-36, and SGRQ total scores in 26 weeks after treatment than before treatment. At of the end of follow-up, a total of 10 patients died, including three and seven in the TCM and control group respectively. And the HR (Hazard ratio) for CM granules in all-cause mortality was 0.39 (95% CI, 0.10–1.52). The drug-related adverse events were not observed.Conclusion: CM granules, as compared with placebo, could reduce frequencies of AEs, improve pulmonary function, HRQoL, exercise capacity and symptoms and signs for IPF to some extent with acceptable side-effect. |
| first_indexed | 2024-04-12T17:59:06Z |
| format | Article |
| id | doaj.art-285ec43ecf7945c199f3b5a7b6c61eb7 |
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| issn | 1663-9812 |
| language | English |
| last_indexed | 2024-04-12T17:59:06Z |
| publishDate | 2022-10-01 |
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| series | Frontiers in Pharmacology |
| spelling | doaj.art-285ec43ecf7945c199f3b5a7b6c61eb72022-12-22T03:22:14ZengFrontiers Media S.A.Frontiers in Pharmacology1663-98122022-10-011310.3389/fphar.2022.10533561053356Efficacy and safety of traditional Chinese medicine treatment for idiopathic pulmonary fibrosis: An exploratory, randomized, double-blinded and placebo controlled trialJiansheng Li0Jiansheng Li1Jiansheng Li2Xue-qing Yu3Xue-qing Yu4Xue-qing Yu5Yang Xie6Yang Xie7Yang Xie8Shu-guang Yang9Shu-guang Yang10Shu-guang Yang11Limin Zhao12Miao Zhou13Yong Meng14Collaborative Innovation Center for Chinese Medicine and Respiratory Diseases Co-constructed by Henan Province and Education Ministry of China, Henan University of Chinese Medicine, Zhengzhou, Henan, ChinaHenan Key Laboratory of Chinese Medicine for Respiratory Disease, Henan University of Chinese Medicine, Zhengzhou, Henan, ChinaDepartment of Respiratory Diseases, The First Affiliated Hospital of Henan University of Chinese Medicine, Zhengzhou, Henan, ChinaCollaborative Innovation Center for Chinese Medicine and Respiratory Diseases Co-constructed by Henan Province and Education Ministry of China, Henan University of Chinese Medicine, Zhengzhou, Henan, ChinaHenan Key Laboratory of Chinese Medicine for Respiratory Disease, Henan University of Chinese Medicine, Zhengzhou, Henan, ChinaDepartment of Respiratory Diseases, The First Affiliated Hospital of Henan University of Chinese Medicine, Zhengzhou, Henan, ChinaCollaborative Innovation Center for Chinese Medicine and Respiratory Diseases Co-constructed by Henan Province and Education Ministry of China, Henan University of Chinese Medicine, Zhengzhou, Henan, ChinaHenan Key Laboratory of Chinese Medicine for Respiratory Disease, Henan University of Chinese Medicine, Zhengzhou, Henan, ChinaDepartment of Respiratory Diseases, The First Affiliated Hospital of Henan University of Chinese Medicine, Zhengzhou, Henan, ChinaCollaborative Innovation Center for Chinese Medicine and Respiratory Diseases Co-constructed by Henan Province and Education Ministry of China, Henan University of Chinese Medicine, Zhengzhou, Henan, ChinaHenan Key Laboratory of Chinese Medicine for Respiratory Disease, Henan University of Chinese Medicine, Zhengzhou, Henan, ChinaDepartment of Respiratory Diseases, The First Affiliated Hospital of Henan University of Chinese Medicine, Zhengzhou, Henan, ChinaDepartment of Respiratory Diseases, Henan Provincial People’s Hospital, Zhengzhou, Henan, ChinaDepartment of Respiratory Diseases, The Third Affiliated Hospital of Henan University of Chinese Medicine, Zhengzhou, Henan, ChinaDepartment of Respiratory Diseases, Henan Province Hospital of Traditional Chinese Medicine, Zhengzhou, Henan, ChinaBackground and objective: Idiopathic pulmonary fibrosis (IPF) is a critical disease, with limited treatments available. Clinical practices show that traditional Chinese medicine (TCM) has certain efficacy. This study was preliminarily to evaluate the efficacy and safety of TCM treatment based on syndrome differentiation in IPF.Methods: A study design of exploratory, multi-centers, randomized, double-blinded, placebo controlled trial has been adopted. A total of 80 IPF patients from four sub-centers were enrolled. All the patients were randomly assigned into TCM group (TCMG) or control group (CG) in 1:1. Patients in TCMG were given CM granules, as patients in CG given with the placebo of CM granule. All the patients received a 26-week treatment. The efficacy was assessed by acute exacerbations (AEs) of IPF, pulmonary function, clinical symptoms, dyspnea scores (mMRC), health-related quality of life (HRQoL), 6-min walk test (6MWT) and all-cause mortality. Safety has also been assessed.Results: A total of 67 patients completed the trial with 35 in TCM group and 32 in control group. Meaningful differences have been observed in mean changes in AEs (−1.56 times; 95% CI, −2.69 to −0.43, p = 0.01), DLco% (5.29; 95% CI, 0.76 to 9.81, p = 0.02), cough scores (−0.38 points; 95% CI, −0.73 to −0.04, p = 0.03), and 6MWT (30.43 m; 95% CI, 2.85 to 58.00, p = 0.03), with no statistical differences in FEV1, FVC, expectoration, chest tightness, Shortness of breath, Fatigue, Cyanosis, mMRC, CAT, SF-36, and SGRQ total scores in 26 weeks after treatment than before treatment. At of the end of follow-up, a total of 10 patients died, including three and seven in the TCM and control group respectively. And the HR (Hazard ratio) for CM granules in all-cause mortality was 0.39 (95% CI, 0.10–1.52). The drug-related adverse events were not observed.Conclusion: CM granules, as compared with placebo, could reduce frequencies of AEs, improve pulmonary function, HRQoL, exercise capacity and symptoms and signs for IPF to some extent with acceptable side-effect.https://www.frontiersin.org/articles/10.3389/fphar.2022.1053356/fullidiopathic pulmonary fibrosisChinese medicinesyndrome differentiationefficacyrandomized controlled trial |
| spellingShingle | Jiansheng Li Jiansheng Li Jiansheng Li Xue-qing Yu Xue-qing Yu Xue-qing Yu Yang Xie Yang Xie Yang Xie Shu-guang Yang Shu-guang Yang Shu-guang Yang Limin Zhao Miao Zhou Yong Meng Efficacy and safety of traditional Chinese medicine treatment for idiopathic pulmonary fibrosis: An exploratory, randomized, double-blinded and placebo controlled trial Frontiers in Pharmacology idiopathic pulmonary fibrosis Chinese medicine syndrome differentiation efficacy randomized controlled trial |
| title | Efficacy and safety of traditional Chinese medicine treatment for idiopathic pulmonary fibrosis: An exploratory, randomized, double-blinded and placebo controlled trial |
| title_full | Efficacy and safety of traditional Chinese medicine treatment for idiopathic pulmonary fibrosis: An exploratory, randomized, double-blinded and placebo controlled trial |
| title_fullStr | Efficacy and safety of traditional Chinese medicine treatment for idiopathic pulmonary fibrosis: An exploratory, randomized, double-blinded and placebo controlled trial |
| title_full_unstemmed | Efficacy and safety of traditional Chinese medicine treatment for idiopathic pulmonary fibrosis: An exploratory, randomized, double-blinded and placebo controlled trial |
| title_short | Efficacy and safety of traditional Chinese medicine treatment for idiopathic pulmonary fibrosis: An exploratory, randomized, double-blinded and placebo controlled trial |
| title_sort | efficacy and safety of traditional chinese medicine treatment for idiopathic pulmonary fibrosis an exploratory randomized double blinded and placebo controlled trial |
| topic | idiopathic pulmonary fibrosis Chinese medicine syndrome differentiation efficacy randomized controlled trial |
| url | https://www.frontiersin.org/articles/10.3389/fphar.2022.1053356/full |
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