Compassionate Use of Yuanjiang Decoction, a Traditional Chinese Medicinal Prescription, for Symptomatic Bradyarrhythmia

Abstract

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.

Association of Sodium-Glucose Cotransporter 2 Inhibitors (SGLT2i) with Cardiac Arrhythmias: A Systematic Review and Meta-Analysis of Cardiovascular Outcome Trials

“…Degenerative fibrosis of the sinoatrial node, atria, atrioventricular node, or other conduction tissues can lead to bradyarrhythmias [ 49 ]. Although drug therapy for bradyarrhythmia is mostly used for acute management, complementary therapies like traditional Chinese medicine, provide a new treatment method for bradyarrhythmias [ 50 , 51 , 52 ], so it is necessary to continuously expand the drug therapy for bradyarrhythmias. Unfortunately, this meta-analysis found that SGLT2i therapy did not reduce the risk of bradycardia, such as sinoatrial dysfunction, atrioventricular block, and conduction tissue disease in patients with T2DM, HF and CKD.…”

Analysis of prescription medication rules of traditional Chinese medicine for bradyarrhythmia treatment based on data mining

“…[9][10][11] Such populations are at greater risk for severe complications and other accidents, and there is an urgent need to find alternatives for them. [12] Traditional Chinese medicine (TCM) has a long history of treating bradyarrhythmias, which began in the Han dynasty in China (more than 2000 years ago). TCM has unique treatment advantages.…”

“…[9–11] Such populations are at greater risk for severe complications and other accidents, and there is an urgent need to find alternatives for them. [12]…”