Background: Multiple studies have revealed that Traditional Chinese Medicine (TCM) prescriptions can provide protective effect on the cardiovascular system, increase the heart rate and relieve the symptoms of patients with bradyarrhythmia. In China, the TCM treatment of bradyarrhythmia is very common, which is also an effective complementary therapy. In order to further understand the application of Chinese medicines in bradyarrhythmia, we analyzed the medication rules of TCM prescriptions for bradyarrhythmia by data mining methods based on previous clinical studies.Methods: We searched studies reporting the clinical effect of TCM on bradyarrhythmia in the PubMed and Chinese databases China National Knowledge Infrastructure database, and estimated publication bias by risk of bias tools ROB 2. Descriptive analysis, hierarchical clustering analysis and association rule analysis based on Apriori algorithm were carried out by Microsoft Excel, SPSS Modeler, SPSS Statistics and Rstidio, respectively. Association rules, co-occurrence and clustering among Chinese medicines were found.Results: A total of 48 studies were included in our study. Among the total 99 kinds of Chinese medicines, 22 high-frequency herbs were included. Four new prescriptions were obtained by hierarchical cluster analysis. 81 association rules were found based on association rule analysis, and a core prescription was intuitively based on the grouping matrix of the top 15 association rules (based on confidence level), of which Guizhi, Zhigancao, Wuweizi, Chuanxiong, Danshen, Danggui, Huangqi, Maidong, Dangshen, Rougui were the most strongly correlated herbs and in the core position. Conclusion:In this study, data mining strategy was applied to explore the TCM prescription for the treatment of bradyarrhythmia, and high-frequency herbs and core prescription were found. The core prescription was in line with the treatment ideas of TCM for bradyarrhythmia, which could intervene the disease from different aspects and adjust the patient's Qi, blood, Yin and Yang, so as to achieve the purpose of treatment.
Background: No effective medication is available for symptomatic bradyarrhythmia, particularly in low socioeconomic status (SES) population.Objective: To explore the safety and efficacy of Yuanjiang decoction, a traditional Chinese medicinal prescription, for symptomatic bradyarrhythmia on a compassionate-use basis.Methods: This compassionate-use study was conducted in Beijing, China between January 2019 and January 2020. Eligible participants were recruited and treated with Yuanjiang decoction (composed of 6 Chinese herbal medicines), 200 ml twice daily for 16 weeks. Analyses were done with the intention-to-treat (ITT) approach. The primary outcome measure was the proportion of participants who achieved a favorable treatment outcome at 16 weeks.Results: As of January 2020, 184 patients were included. After 16-weeks treatment, 12 participants were lost to contact while 21 participants were terminated from this study, with a drop-out rate of 17.93%. The most common treatment-related adverse events were xerostomia (6.52%), constipation (6.45%) and sleepiness (3.26%). The proportion of participants with favorable treatment outcome was 65.22% at 4 weeks, 59.78% at 8 weeks (OR: 1.11, 95% CI: 0.71–1.73), 61.41% at 12 weeks (OR: 1.16, 95% CI: 0.92–1.45) and 60.87% at 16 weeks (OR: 1.15, 95% CI: 0.98–1.35). In the multifactor regression analysis, the favorable treatment outcome at 16 weeks was significantly associated with completing at least 8 weeks treatment (OR: 2.053, 95% CI: 1.064–3.560), while unfavorable treatment outcome was significantly associated with an atrioventricular block (OR: 0.255, 95% CI: 0.083–0.784), current smoking (OR: 0.343, 95% CI: 0.027–0.487), and syncope in the month before treatment (OR: 0.321, 95%CI: 0.114–0.904).Conclusion: This compassionate-use study showed encouraging outcomes of treatment with Yuanjiang decoction, without serious adverse events. This study identified several key factors that may affect outcomes. These findings helped inform the design and assess the feasibility of a large-scale randomized clinical trial.
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