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| Summary and evaluation of clinical research on the treatment of type 2 diabetes mellitus with Chinese patent medicine |
| Hits 714 Download times 847 Received:September 29, 2022 |
| View Full Text View/Add Comment Download reader |
| DOI
10.11656/j.issn.1672-1519.2023.01.12 |
| Key Words
Chinese patent medicine;type 2 diabetes mellitus;randomized controlled trial;evidence based medicine |
| Author Name | Affiliation | E-mail | | WANG Danlei | 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 | | | FENG Chaonan | 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 | | | WU Xiaolei | Evidence Based Medicine Center, Tianjin University of Traditional Chinese Medicine, Tianjin 301617, China | | | PENG Dehui | 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 | caolujia0825@163.com | | 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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| To summarize and analyze the basic situation and methodological quality of the randomized controlled trials (RCT) of Chinese patent medicine for type 2 diabetes mellitus (T2DM),the databases of EVDS,CNKI,WanFang and CBM were retrieved. The time of screening was from database inception to December 31,2020. RCTs were included in the research type. The intervention and control measures,course of treatment,outcome indicators and methodological quality were analyzed and evaluated. There were 377 RCTs studies involving Chinese patent medicine in the treatment of T2DM,of which 26 were include patients more than 200,accounting for 6.90%. 79 kinds of Chinese patent medicines were involved,including 54 kinds of oral Chinese patent medicines(68.35%) and 25 kinds of injection (31.65%);The intervention vs control setting was “Chinese patent medicine+western medicine vs western medicine”,involving 93 RCTs,accounting for 24.67% of the total included literature;The main course of treatment was 31 to 90 days (194 articles,51.46%). Among the evaluation outcomes,physical and chemical test outcomes (81.70%) and symptom/sign outcomes (10.00%) were the most used. The published Chinese patent medicine has some defects in the design and implementation of RCTs for T2DM. Most of the patients studied were saved by the allocation sequence,and the blindness of subjects was rated as high risk. The reports of key research links such as trial registration and ethical approval are insufficient. It is suggested to carry out large sample and high-quality RCT research in the follow-up,invite methodological experts to provide professional and technical support in the test design,comply with the requirements of key links such as test registration and ethical approval,and report the results in strict accordance with the consort reporting specification,so as to further improve the reliability of evidence. |
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