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| Selection and evaluation of outcome measures in randomized controlled trials of traditional Chinese medicine for the treatment of pulmonary hypertension |
| Hits 47 Download times 15 Received:January 12, 2026 |
| View Full Text View/Add Comment Download reader |
| DOI
10.11656/j.issn.1672-1519.2026.05.07 |
| Key Words
pulmonary hypertension;traditional Chinese medicine;randomized controlled trial;outcome measures |
| Author Name | Affiliation | E-mail | | LI Mingwei | First Teaching Hospital of Tianjin University of Traditional Chinese Medicine, Tianjin 300381, China
National Clinical Research Center for Chinese Medicine, Tianjin 300381, China
Graduate School, Tianjin University of Traditional Chinese Medicine, Tianjin 301617, China | | | WANG Shuai | First Teaching Hospital of Tianjin University of Traditional Chinese Medicine, Tianjin 300381, China
National Clinical Research Center for Chinese Medicine, Tianjin 300381, China | | | WANG Lin | Department of Cardiology, Shenzhen Hospital of Integrated Traditional Chinese and Western Medicine, Shenzhen 518104, China | | | ZHOU Zhou | First Teaching Hospital of Tianjin University of Traditional Chinese Medicine, Tianjin 300381, China
National Clinical Research Center for Chinese Medicine, Tianjin 300381, China
Graduate School, Tianjin University of Traditional Chinese Medicine, Tianjin 301617, China | | | ZHOU Mengxue | Second Affiliated Hospital of Yunnan University of Chinese Medicine, Kunming 650041, China | | | WANG Xianliang | First Teaching Hospital of Tianjin University of Traditional Chinese Medicine, Tianjin 300381, China
National Clinical Research Center for Chinese Medicine, Tianjin 300381, China | | | MAO Jingyuan | First Teaching Hospital of Tianjin University of Traditional Chinese Medicine, Tianjin 300381, China
National Clinical Research Center for Chinese Medicine, Tianjin 300381, China | jymao@126.com |
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| Abstract
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| [Objective] To evaluate the selection and reporting of outcome measures used in randomized controlled trials（RCTs） of traditional Chinese medicine（TCM） for pulmonary hypertension（PH）. [Methods] Seven databases（China National Knowledge Infrastructure，Wanfang Data，VIP Database，SinoMed，PubMed，Cochrane Library，and Web of Science） were systematically searched from inception to December 31，2024. RCTs investigating TCM interventions for PH were included. Two reviewers independently screened studies and extracted data. The risk of bias and the characteristics of outcome measures were analyzed and evaluated. [Results] A total of 107 RCTs involving 9 454 participants were included. Overall，730 reporting instances of outcome measures were extracted and categorized into five domains：endpoint events（3 times，0.41%），symptoms/signs（clinical symptom efficacy 90 times，TCM symptoms/syndromes 69 times，total 21.78%），exercise capacity and quality of life（exercise capacity 50 times，quality of life 26 times，total 10.41%），laboratory/instrumental assessments（440 times，60.28%），and safety outcomes（52 times，7.12%）. Only one trial explicitly distinguished primary and secondary outcomes. The three most frequently reported outcomes were clinical symptom effective rate，echocardiography-estimated pulmonary artery systolic pressure，and TCM syndrome score. Most trials assessed outcomes at 4 weeks after treatment initiation. The evaluation of TCM symptoms/syndromes was mainly based on the Guiding Principles for Clinical Research of New Chinese Herbal Medicine（Trial Implementation）. [Conclusion] In recent years，the number of RCTs on TCM for PH has increased；however，the selection and application of outcome measures remain heterogeneous and insufficiently standardized. Developing a core outcome set（COS） that reflects the characteristics and advantages of TCM is warranted to improve the quality and standardization of future clinical research. |
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