Current analysis of outcomes in randomized controlled trials of traditional Chinese medicine for bradyarrhythmia
[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.
bradyarrhythmiatraditional Chinese medicinerandomized controlled trialoutcome indicatorcore set of outcome measure
万方数据
维普
