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Clinical trials and evaluation of Chinese patent medicine for arrhythmia
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DOI   10.11656/j.issn.1672-1519.2022.09.15
Key Words   Chinese patent medicine;arrhythmia;randomized controlled trial;evidence-based medicine
Author NameAffiliationE-mail
HU Haiyin 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  
FENG Chaonan 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  
SHENG Xiaodi Evidence-based Medicine Center, Tianjin University of Traditional Chinese Medicine, Tianjin 301617, China  
WANG Hui Evidence-based Medicine Center, Tianjin University of Traditional Chinese Medicine, Tianjin 301617, China wangh@tice.com.cn 
Abstract
    [Objective] This study reviewed the clinical randomized controlled trials (RCTs) of Chinese patent medicine for arrhythmia to provide references for clinical research,guideline development,and policy formulation.[Methods] EVDS,PubMeb,Web of Science were searched for RCTs of Chinese patent medicine for arrhythmia from database inception to December 31,2020.[Results] A total of 1 934 RCTs were included,involving 100 Chinese patent medicines,including 82 oral medicines and 18 injections.Treatment course of 64.89% RCTs were 15 to 30 d;38.00% of RCTs had a sample size of more than 100 cases;65 types of interventions/controls were involved in the RCTs,with Chinese patent medicine+Western medicine vs.western medicine as the top one used (27.25%).In outcomes,symptoms/signs (3 106) and physicochemical detection (2 616) were the most frequently applied.High difference were in the methodological quality between Chinese RCTs and English RCTs.RCTs'methodological quality were not improve in near 4 years.[Conclusion] Many deficiencies in the RCTs of Chinese patent medicine for arrhythmia,such as small study size,not clear clinical value proposition,study design that fails to reflect the value of Chinese patent medicine,unscientific outcomes,unreasonable measured methods.Future studies should give priority to above problem and solve them,improving the quality and value of studies and enhancing the reliability and extrapolation of evidence.

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