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| Review of reports of clinical evidence of Chinese patent medicines in 2019—2020 |
| Hits 609 Download times 638 Received:December 06, 2021 |
| View Full Text View/Add Comment Download reader |
| DOI
10.11656/j.issn.1672-1519.2022.05.15 |
| Key Words
Chinese patent medicine;randomized controlled trial;evidence-based medicine |
| Author Name | Affiliation | E-mail | | OU Yi | Evidence-based Medicine Center, Tianjin University of Traditional Chinese Medicine, Tianjin 301617, China | | | JI Zhaochen | Evidence-based Medicine Center, Tianjin University of Traditional Chinese Medicine, Tianjin 301617, China | | | HU Haiyin | Evidence-based Medicine Center, Tianjin University of Traditional Chinese Medicine, Tianjin 301617, China | | | QIANG Xiaoyu | Evidence-based Medicine Center, Tianjin University of Traditional Chinese Medicine, Tianjin 301617, China | | | CAO Lujia | Evidence-based Medicine Center, Tianjin University of Traditional Chinese Medicine, Tianjin 301617, China | | | ZHANG Junhua | Evidence-based Medicine Center, Tianjin University of Traditional Chinese Medicine, Tianjin 301617, China | zjhtcm@foxmail.com |
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| Abstract
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| [Objective] The application and popularization of evidence-based medicine have led to the explosion of clinical trials of traditional Chinese medicine. This study summarized and evaluated the relevant studies in 2019-2020 and made reasonable suggestions,aiming to promote the transformation and application of research evidence.[Methods] Based on the Evidence-Based Evaluation of Chinese Medicine Evidence Database System(EVDS),supplemented by the supplementary search of the literature database,the literatures of randomized controlled trials of Chinese patent medicines published in 2019-2020 were obtained and statistically analyzed.[Results] A total of 2 463 articles (2 439 in Chinese and 24 in English) were included for analysis. Among them,149 (6.11%) articles were published in Chinese core journals,and 91 (3.73%) articles in thejournals listed in CSCD. A total of 547 Chinese patent medicines were involved,including 77 injections and 470 oral/topical medicines. The research hotspots involved circulatory system diseases,nervous system diseases,and respiratory disorders. Among the randomized controlled trials (RCTs),single-center studies accounted for 98.29%,and multi-center studies accounted for only 1.71%. In terms of sample size,56.23% RCTs involved fewer than 100 cases. About methodology evaluation,44.18% RCTs had unclear descriptions of randomization methods or incorrect applications,and the low-risk rates of the items such as allocation concealment,blinding,and other biases were all less than 5%. In addition,the issues in ethical review and program registration still existed.[Conclusion] Although a large number of RCTs have been published,there are common methodological problems and insufficient papers published in high-impact journals. In the future,methodological training should be enhanced for researchers to improve the output of high-quality research data and promote the transformation and application of research data,so as to provide a basis for reasonable decision-making. |
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