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| Literature analysis of randomized controlled trials of proprietary Chinese medicines in the treatment of diabetic eye disease |
| Hits 69 Download times 32 Received:May 15, 2024 |
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| DOI
10.11656/j.issn.1672-1519.2024.10.11 |
| Key Words
diabetic eye disease;evidence-based medicine;traditional Chinese medicine;clinical evaluation;RCT;literature analysis |
| Author Name | Affiliation | E-mail | | ZHANG Yazi | 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
School of Traditional Chinese Medicine, Tianjin University of Traditional Chinese Medicine, Tianjin 301617, China | | | SONG Wenting | Evidence-Based Medicine Center, Tianjin University of Traditional Chinese Medicine, Tianjin 301617, China | | | WANG Yuetong | Evidence-Based Medicine Center, Tianjin University of Traditional Chinese Medicine, Tianjin 301617, China | | | HU Haiyin | Hai-he Laboratory of Modern Chinese Medicine, Tianjin 301617, China | | | PENG Dehui | Evidence-Based Medicine Center, Tianjin University of Traditional Chinese Medicine, Tianjin 301617, China | | | WANG Danlei | Evidence-Based Medicine Center, Tianjin University of Traditional Chinese Medicine, Tianjin 301617, China | | | WU Xiaolei | Evidence-Based Medicine Center, Tianjin University of Traditional Chinese Medicine, Tianjin 301617, China | | | SHI Menglong | Evidence-Based Medicine Center, Tianjin University of Traditional Chinese Medicine, Tianjin 301617, China | | | JIN Xinyao | Evidence-Based Medicine Center, Tianjin University of Traditional Chinese Medicine, Tianjin 301617, China | | | YANG Fengwen | Evidence-Based Medicine Center, Tianjin University of Traditional Chinese Medicine, Tianjin 301617, China | 13682027022@163.com |
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| Abstract
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| [Objective] Through systematically collecting,analyzing,and evaluating the relevant randomized controlled trial(RCT) literature on the treatment of diabetic eye disease with traditional Chinese medicine(TCM),this study summarizes its clinical application value and provides a basis for future RCT research,guidelines,and insurance policy formulation. [Methods] Based on the Traditional Chinese Medicine Evidence-based Research Evidence Database System(EVDS) under the AICED-CPM database of the Chinese Medicine Clinical Evidence Database(AICED),literature was collected from eight other databases,from the establishment of the database to December 2022,and relevant literature was selected according to the inclusion and exclusion criteria. The publication year,region of issuance and disease profile were integrated and evaluated. [Results] A total of 417 RCTs on the treatment of diabetic eye disease with TCM were included,with the earliest publication in 1998 and the highest number of publications in 2017(51,12.23%). The region with the highest number of publications was Henan. The RCT,in most cases,was diabetic retinopathy. The intervention/control measures with the most cases were TCM combined with Western medicine vs. Western medicine(122,29.26%). The 90.17% of the literature reported the duration of treatment,with the majority being 61 to 90 days. The outcome indicator used most frequently was symptoms and signs(1 011 times,44.42%)；the least commonly used was economic evaluation indicators(6 times,0.26%). In terms of methodological quality,only 1.92% reported allocation concealment；96.40% of the study subjects were at high risk of being blinded. In the CONSORT statement analysis of randomized controlled trials(RCTs) on the treatment of diabetic eye disease with Chinese herbal medicine,out of 417 RCTs,only 2 had complete reporting,and 7 had no reporting. [Conclusion] Chinese herbal medicine for the treatment of diabetic eye disease is widely used,driving new progress in the treatment of eye diseases with TCM. The selection of outcome indicators is not standardized,the names of indicators are numerous and inconsistent,and it is difficult to provide clinical value. There are also problems of non-standardization in research design and small scale. It is urgent to accelerate the establishment of core indicators with distinctive features of TCM to provide more scientific and rigorous trial data for clinical research. The sample size,trial registration,and informed consent methods all have obvious shortcomings,and the authenticity,scientificity,standardization,and generalizability of the literature need to be improved. |
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