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| Current analysis of outcomes in randomized controlled trials of traditional Chinese medicine for bradyarrhythmia |
| Hits 8 Download times 1 Received:September 09, 2024 |
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| DOI
10.11656/j.issn.1672-1519.2024.12.13 |
| Key Words
bradyarrhythmia;traditional Chinese medicine;randomized controlled trial;outcome indicator;core set of outcome measure |
| Author Name | Affiliation | E-mail | | ZHANG Xuexue | Xiyuan Hospital of China Academy of Chinese Medical Sciences, Beijing 100091, China | | | ZHANG Wantong | Xiyuan Hospital of China Academy of Chinese Medical Sciences, Beijing 100091, China | | | WANG Xujie | Xiyuan Hospital of China Academy of Chinese Medical Sciences, Beijing 100091, China | | | LI Mengxuan | Xiyuan Hospital of China Academy of Chinese Medical Sciences, Beijing 100091, China | | | WENG Weiliang | Xiyuan Hospital of China Academy of Chinese Medical Sciences, Beijing 100091, China | | | LI Qiuyan | Xiyuan Hospital of China Academy of Chinese Medical Sciences, Beijing 100091, China | liqiuyan0928@163.com |
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| Abstract
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| [Objective] This study aims to assess the current status of outcome indicators in randomized controlled trials（RCTs） investigating the effectiveness of traditional Chinese medicine（TCM） in treating bradyarrhythmia，laying the foundation for the construction of a core set of indicators for TCM treatment of bradyarrhythmia. [Methods] A comprehensive search was conducted across eight databases，including China National Knowledge Infrastructure（CNKI），Wanfang Data，VIP Database，SinoMed，PubMed，Web of Science， Cochrane Library，and Embase，covering studies from inception to December 2023. The included studies were assessed for risk of bias，and the outcome indicators were analyzed and summarized. [Results] In total，322 articles were included，involving 30 854 participants and reporting 93 outcome indicators. The top ten most frequently utilized indicators were clinical efficacy（78.6%），24-hour average heart rate（60.0%），heart rate（57.5%），adverse reactions（45.7%），24-hour slowest heart rate（31.1%），laboratory safety indicators（24.8%），TCM syndrome score（21.7%），24-hour total heartbeats（16.1%），electrocardiogram efficacy（15.8%），and 24-hour fastest heart rate（13.7%）. The included articles encompassed 23 measurement time points，with 63.0% of the studies having a treatment duration of 4 weeks. [Conclusion] The outcome indicators in RCTs evaluating TCM treatment for bradyarrhythmia exhibit several challenges，including substantial heterogeneity in selected indicators，unclear indicator definitions，insufficient differentiation between subjective and objective measures，and a lack of attention to long-term and economic indicators. Urgent efforts are needed to construct a standardized core set of outcome indicators for evaluating the efficacy of TCM interventions in bradyarrhythmia treatment，fostering the high-quality development of TCM research. |
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