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

Zhang Wan-Tong; Zhu Bao-Chen; Liu Zhao; Wang Xu-Jie; Gao Rui; Xiao Ning; Tang Wei; Wu Yu-Fei; Phoebe Miles; Weng Wei-Liang; Lin Hao-Xiang; Li Qiu-Yan

doi:10.3389/fphar.2022.764930

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

Front Pharmacol. 2022 Apr 11:13:764930. doi: 10.3389/fphar.2022.764930. eCollection 2022.

Authors

Zhang Wan-Tong^{1

2

3}, Zhu Bao-Chen⁴, Liu Zhao⁵, Wang Xu-Jie^{1

2

3}, Gao Rui^{1

2

3}, Xiao Ning², Tang Wei³, Wu Yu-Fei³, Phoebe Miles⁶, Weng Wei-Liang^{1

2}, Lin Hao-Xiang⁷, Li Qiu-Yan^{2

3

8}

Affiliations

¹ Institute of Clinical Pharmacology, Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing, China.
² National Clinical Research Center for Chinese Medicine Cardiology, Beijing, China.
³ NMPA Key Laboratory for Clinical Research and Evaluation of Traditional Chinese Medicine, Beijing, China.
⁴ Department of Pharmacy, Dongzhimen Hospital, Beijing University of Chinese Medicine, Beijing, China.
⁵ Tobacco Medicine and Tobacco Cessation Center, China-Japan Friendship Hospital, Beijing, China.
⁶ Faculty of Humanities and Social Sciences, University of Nottingham, Ningbo, China.
⁷ Department of Social Medicine and Health Education, School of Public Health, Peking University Health Science Center, Beijing, China.
⁸ Stroke Center, Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing, China.

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.

Keywords: Yuanjiang decoction; bradyarrhythmia; compassionate use; prospective pilot trial; traditional Chinese medicinal prescription.