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| Summary and evaluation of randomized controlled trial on Chinese patent medicine treatment of diabetic kidney disease |
| Hits 82 Download times 31 Received:March 16, 2024 |
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| DOI
10.11656/j.issn.1672-1519.2024.09.11 |
| Key Words
diabetic kidney disease;Chinese patent medicine;randomized controlled trial;evidence transformation;evidence-based medicine |
| Author Name | Affiliation | E-mail | | WANG Yuetong | Center of Evidence-Based Medicine, Tianjin University of Traditional Chinese Medicine, Tianjin 301617, China | | | JI Zhaochen | Center of Evidence-Based Medicine, Tianjin University of Traditional Chinese Medicine, Tianjin 301617, China | | | ZHANG Yazi | Center of Evidence-Based Medicine, Tianjin University of Traditional Chinese Medicine, Tianjin 301617, China | | | SONG Wenting | Center of Evidence-Based Medicine, Tianjin University of Traditional Chinese Medicine, Tianjin 301617, China | | | JIN Xinyao | Center of Evidence-Based Medicine, Tianjin University of Traditional Chinese Medicine, Tianjin 301617, China | | | PANG Wentai | Center of Evidence-Based Medicine, Tianjin University of Traditional Chinese Medicine, Tianjin 301617, China | | | YANG Fengwen | Center of Evidence-Based Medicine, Tianjin University of Traditional Chinese Medicine, Tianjin 301617, China | 13682027022@163.com |
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| Abstract
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| [Objective] To systematically collect，analyze and evaluate the clinical randomized controlled trial （RCT） of proprietary Chinese patent medicine in the treatment of diabetic kidney disease （DKD），summarizing the whole picture of evidence and providing reference for subsequent clinical studies and related studies. [Methods] Literature resources were based on the evidence-based research of traditional Chinese medicine evidence database system （EVDS） under the intelligent proprietary Chinese medicine clinical evidence database（AICED-CPM），we supplementary searched six common databases，including CNKI，VIP and so on，with the search period from the establishment of the database to December 31，2022. The type of disease，time to publication，sample size，intervention/controlsettings， evaluation methods and methodological quality were analyzed and evaluated. [Results] The 2 086 RCTs were included，of which 529 RCTs with>100 patients were included；a total of 160 kinds of proprietary Chinese medicines were involved；a total of 20 counting indicators and 381 measures were applied；in terms of methodology，97.75% of articles had researcher and subject blinding omissions； 86.05% of articles had other bias risks；and only 6 RCTs（0.29%） reported trial registration and 4（0.19%） reported sample size estimation. [Conclusion] The overall methodological quality of proprietary Chinese medicines for DKD was low，and the main problems included missing trial registration and ethical approvals；there were significant deficiencies in the reporting especially of 2 aspects：allocation concealment，other biases and so on. Subsequent relevant clinical studies should pay attention to and solve the above problems， standardize the design and implementation of relevant clinical studies，highlight the clinical value，and improve the quality of evidence. |
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