STUDY PROTOCOL article
Front. Cardiovasc. Med.
Sec. Cardio-Oncology
Investigation of Sheng Mai Yin in the treatment of anthracycline-induced frequent premature ventricular contractions in cancer patients: study protocol for a multicenter, randomized, double-blind, placebo-controlled clinical trial
Provisionally accepted
Qiwen Yang1
Chaofeng Niu1
Meng Li1,2Tangshun Wang1Ce Wang1Longzhen Han1Lan Wei1Yayue Zhang1
Li Dong3
Shuhua Yi4
Duolao Wang5*
Lijing Zhang1*- 1Dongzhimen Hospital, Beijing University of Chinese Medicine, Beijing, China
- 2University of Liverpool, Liverpool, United Kingdom
- 3Peking University Third Hospital, Beijing, China
- 4Institute of Hematology and Blood Disease Hospital, Chinese Academy of Medical Sciences, Tianjin, China
- 5Liverpool School of Tropical Medicine Department of Clinical Sciences, Liverpool, United Kingdom
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Introduction: Anthracycline-induced cardiotoxicity is a major concern in cancer treatment, as it can lead to various arrhythmias, with frequent premature ventricular contractions (PVCs) being one of the most common types. Sheng Mai Yin (SMY), a widely used Chinese herbal compound in China, has shown potential in treating anthracycline-induced cardiac dysfunction and arrhythmias. However, the evidence supporting its efficacy is limited due to methodological flaws in prior studies. Therefore, high-quality trials are essential to rigorously evaluate the efficacy and safety of SMY. Methods: This multicenter, randomized, double-blind, placebo-controlled trial will assess the efficacy and safety of SMY in treating frequent PVCs induced by anthracycline chemotherapy. A total of 212 patients with breast cancer or malignant lymphoma undergoing anthracycline-based chemotherapy, who have been diagnosed with new-onset frequent PVCs and Qi and Yin deficiency syndrome, will be enrolled. Participants will be randomly assigned to receive either SMY or a placebo for 8 weeks, alongside standard medications. The primary outcome is the reduction rate in PVC frequency. Secondary outcomes include PVC symptom scores, Traditional Chinese Medicine syndrome scores, cardiac dysfunction biomarkers, and major adverse cardiovascular events. Discussion: The results of this trial are expected to provide robust evidence regarding the efficacy and safety of SMY in the treatment of anthracycline-induced frequent PVCs. Trial registration: http://itmctr.ccebtcm.org.cn. Registration number: ITMCTR2024000858. Registered on 29 September 2024.
Keywords: Traditional Chinese Medicine, Sheng Mai Yin, Qi and yin deficiency syndrome, Anthracycline-induced cardiotoxicity, Frequent premature ventricular contractions, Cardio-oncology
Received: 21 Jul 2025; Accepted: 11 Nov 2025.
Copyright: © 2025 Yang, Niu, Li, Wang, Wang, Han, Wei, Zhang, Dong, Yi, Wang and Zhang. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
* Correspondence:
Duolao Wang, duolao.wang@lstmed.ac.uk
Lijing Zhang, dzmyyccu@163.com
Disclaimer: All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article or claim that may be made by its manufacturer is not guaranteed or endorsed by the publisher.