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| Summary and evaluation of randomized controlled trial on Chinese patent medicine in treatment of vertigo |
| Hits 61 Download times 19 Received:August 28, 2024 |
| View Full Text View/Add Comment Download reader |
| DOI
10.11656/j.issn.1672-1519.2025.01.10 |
| Key Words
Chinese patent medicine;vertigo;randomized controlled trial;evidence-based medicine;clinical evaluation |
| Author Name | Affiliation | E-mail | | LI Zhaoji | Department of Encephalopathy, The First Affiliated Hospital of Henan University of Traditional Chinese Medicine, Zhengzhou 450000, China
The First Clinical Medical College of Henan University of Traditional Chinese Medicine, Zhengzhou 450000, China | | | ZHANG Yazi | Tianjin University of Traditional Chinese Medicine, Tianjin 301617, China | | | SHI Menglong | Tianjin University of Traditional Chinese Medicine, Tianjin 301617, China | | | ZHANG Yonghui | Department of Encephalopathy, The First Affiliated Hospital of Henan University of Traditional Chinese Medicine, Zhengzhou 450000, China
The First Clinical Medical College of Henan University of Traditional Chinese Medicine, Zhengzhou 450000, China | | | DONG Juan | Department of Encephalopathy, The First Affiliated Hospital of Henan University of Traditional Chinese Medicine, Zhengzhou 450000, China
The First Clinical Medical College of Henan University of Traditional Chinese Medicine, Zhengzhou 450000, China | | | JI Zhaochen | Tianjin University of Traditional Chinese Medicine, Tianjin 301617, China | robin_johnson@foxmail.com | | ZHAO Min | Department of Encephalopathy, The First Affiliated Hospital of Henan University of Traditional Chinese Medicine, Zhengzhou 450000, China
Collaborative Innovation Center of Prevention and Treatment of Major Diseases by Chinese and Western Medicine, Zhengzhou 450000, China | byts1969@126.com |
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| Abstract
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| [Objective] This study collected and sorted out the clinical randomized controlled trials（RCTs） of Chinese patent medicine in the treatment of vertigo since the establishment of each database，systematically evaluated and analyzed，provided reference for the follow-up study，helped to improve the quality of clinical evidence，and provided the basis for the formulation of relevant guidelines. [Methods] Based on the literature included in the Chinese patent medicine clinical evidence database（AICED-CPM） under the evidence-based Chinese medicine research evidence database system（EVDS），combined with the retrieval of Chinese patent medicine treatment of vertigo RCT in Chinese and English databases such as CNKI and Wanfang data knowledge service platform（Wanfang Database），statistical analysis was conducted. RoB and CONSORT were applied to evaluate the included literature. [Results] A total of 242 RCTs that met the exclusion criteria were retrieved. Among them，7 RCTs with a sample size of 300 patients or more were included，including 8 kinds of Chinese patent medicines. It involved 97 kinds of Chinese patent medicines（65 kinds of oral Chinese patent medicines and 32 kinds of traditional Chinese medicine injections），and gastrodine injection（75 articles，30.99%） was the most published Chinese patent medicines. There were 27 intervention/control designs，of which “Chinese patent medicines+Western medicine vs. Western medicine” was the most commonly used design（66 articles，27.27%）. The main duration of treatment was 7 to 28 days（164 articles，67.77%）. Among the evaluation indexes，there were 9 counting indexes（331 times） and 46 measuring indexes（599 times）. In terms of methodological quality，allocation concealment and other biases are at medium and high risk. In terms of reporting quality，methods，random methods，and some small items in the discussion are poorly reported. [Conclusions] The methodological quality and reporting quality of RCT for treatment of vertigo with Chinese patent medicines are low，the risk of bias is too high，and the trial design is not rigorous. Follow-up research should follow the CONSORT declaration to standardize the design of research protocols，strengthen quality control during the research process，attach importance to experiment registration，provide a higher-level evidence support for the formulation of guidelines，and provide a valuable reference for future research. |
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