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| Current status analysis of outcomes in randomized controlled trials of traditional Chinese medicine in treatment of diabetic retinopathy |
| Hits 64 Download times 29 Received:April 15, 2026 |
| View Full Text View/Add Comment Download reader |
| DOI
10.11656/j.issn.1672-1519.2026.07.08 |
| Key Words
traditional Chinese medicine;diabetic retinopathy;randomized controlled trial;outcomes indicator;core outcome set |
| Author Name | Affiliation | E-mail | | YIN Zihao | Beijing University of Chinese Medicine, Beijing 100029, China
Dongfang Hospital, Beijing University of Chinese Medicine, Beijing 100078, China | | | WANG Xiaolei | Dongfang Hospital, Beijing University of Chinese Medicine, Beijing 100078, China | | | ZHOU Hui | Dongfang Hospital, Beijing University of Chinese Medicine, Beijing 100078, China | | | YANG Zepei | Dongfang Hospital, Beijing University of Chinese Medicine, Beijing 100078, China | | | XIE Wenying | Beijing University of Chinese Medicine, Beijing 100029, China
Dongfang Hospital, Beijing University of Chinese Medicine, Beijing 100078, China | | | LI Wenhui | Beijing University of Chinese Medicine, Beijing 100029, China
Dongfang Hospital, Beijing University of Chinese Medicine, Beijing 100078, China | | | WU Changjiang | Beijing University of Chinese Medicine, Beijing 100029, China
Dongfang Hospital, Beijing University of Chinese Medicine, Beijing 100078, China | | | HAO Liwei | Beijing University of Chinese Medicine, Beijing 100029, China
Dongfang Hospital, Beijing University of Chinese Medicine, Beijing 100078, China | | | ZHANG Kejing | Dongzhimen Hospital, Beijing University of Chinese Medicine, Beijing 100700, China | | | ZHANG Xinjie | Shanxi University of Traditional Chinese Medicine, Jinzhong 030619, China | | | ZHANG Taojing | Dongfang Hospital, Beijing University of Chinese Medicine, Beijing 100078, China | tjzhang81@163.com |
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| Abstract
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| [Objective] To systematically sort out the current application status of outcome indicators in randomized controlled trials （RCTs）of traditional Chinese medicine in the treatment of diabetic retinopathy（DR），and to provide reference for the construction of a core outcome set（COS）for traditional Chinese medicine treatment of DR. [Methods] A computer-based search was conducted in 7 major databases，including CNKI，Wanfang Database，VIP，SinoMed，PubMed，Cochrane Library，and Web of Science，for literatures published from the establishment of the databases to February 27，2025. The Cochrane Risk of Bias Assessment Tool was used to evaluate the risk of bias in the literatures，and the literature information was extracted into Excel spreadsheets for description. [Results] A total of 423 RCTs were finally included，with 385 types of outcome indicators summarized，used a total of 2 830 times. The distribution of outcome indicators in the 7 major indicator domains was as follows：traditional Chinese medicine syndromes（4 types， 129 times），clinical symptoms/signs（158 types，1 205 times），physical and chemical tests（197 types，1 326 times），quality of life （13 types，22 times），long-term prognosis（8 types，31 times），safety events（5 types，117 times），and economic evaluation（0 type， 0 time）. The included literatures had the following problems：insufficient control of bias risk，with the methods of random sequence generation，allocation concealment，and blinding not clearly stated in most literatures；complicated terminology for traditional Chinese medicine syndrome differentiation and classification，with inconsistent names of syndromes；unclear reference and non-standard use of indicator names；lack of economic indicators，leading to unclear economic burden；misuse of composite outcome indicators and lack of objectivity in judgment criteria；unclear primary and secondary outcome indicators，resulting in the need to improve the overall credibility. [Conclusion] At present，there are still deficiencies in RCTs of traditional Chinese medicine research on DR. It is suggested to construct a COS for traditional Chinese medicine treatment of DR to improve the quality of future research and promote the international development of traditional Chinese medicine. |
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