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| Analysis of outcome indicators in randomized controlled trials of traditional Chinese medicine in the treatment of diabetic lower extremity vascular disease |
| Hits 291 Download times 145 Received:April 02, 2025 |
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| DOI
10.11656/j.issn.1672-1519.2025.09.10 |
| Key Words
traditional Chinese medicine;diabetic lower extremity vascular disease;randomized controlled trial;outcome indicator |
| Author Name | Affiliation | E-mail | | LI Qin | Institute of Information on Traditional Chinese Medicine, China Academy of Chinese Medical Sciences, Beijing 100700, China | | | HE Jiayi | Institute of Information on Traditional Chinese Medicine, China Academy of Chinese Medical Sciences, Beijing 100700, China | | | YANG Shuo | Institute of Information on Traditional Chinese Medicine, China Academy of Chinese Medical Sciences, Beijing 100700, China | | | LI Haiyan | Institute of Information on Traditional Chinese Medicine, China Academy of Chinese Medical Sciences, Beijing 100700, China | lihaiyan01@126.com |
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| Abstract
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| [Objective] This study aims to comprehensively evaluate the utilization patterns of efficacy measures in clinical trials investigating traditional Chinese medicine（TCM） interventions for diabetic peripheral vascular complications. The findings are expected to establish an evidence-based framework to optimize therapeutic strategies and enhance methodological rigor in future clinical investigations. [Methods] A comprehensive systematic search was conducted across multiple databases，including China National Knowledge Infrastructure（CNKI），Wanfang Database，VIP Journal Integration Platform，SinoMed，PubMed，Cochrane Library，and Web of Science Core Collection. The search aimed to identify randomized controlled trials（RCTs） focusing on the treatment of diabetic lower extremity vascular disease with traditional Chinese medicine. The methodological quality of the included studies was assessed using the Cochrane Risk of Bias tool. Descriptive statistical methods were employed to quantitatively analyze the study outcomes. [Results] Finally，73 articles were included，and the outcome indicators were extracted，which were mainly divided into 8 categories. According to the frequency of use，the outcome indicators from high to low were biochemical indicators，safety evaluation indicators，clinical efficacy rate，symptoms and signs，TCM syndrome efficacy，blood pressure indicators，other indicators and quality of life indicators. [Conclusion] The results showed that the risk of bias in outcome indicators for the treatment of diabetic lower extremity vascular ratio changes in traditional Chinese medicine was high. Some literature research had problems like designs not rigorous，the characteristic indicators of traditional Chinese medicine lacked diagnostic criteria to be standardized，the diverse selection of outcome indicators lacked standardization and consistency，the distinction between primary and secondary indicators was not clear，etc. It is suggested that the clinical research of traditional Chinese medicine in the treatment of diabetic lower extremity vascular disease in the future needs to improve the methodological quality，standardize the selection of outcome indicators，and strengthen the evaluation of long-term prognosis and safety indicators to ensure the objectivity，reliability and comprehensiveness of the research results. |
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