Ying Lin1, Xian Wang2, Xue-Bin Li3, Bang-Qi Wu4, Zhao-Hui Zhang5, Wei-Hua Guo6, Cun-Cao Wu3, Xin Chen7, Ming-Long Chen8, Zhong Dai9, Fu-Yan Chen4, Rui Zhu5, Chu-Xi Liang9, Yun-Peng Tian7, Gang Yang8, Chao-Qun Yan10, Jing Lu5, Hai-Ying Wang6, Jin-Ling Li1, Jian-Feng Tu11, He-Wen Li1, Dan-Dan Yang3, Fang-Ting Yu1, Yu Wang1, Jing-Wen Yang1, Guang-Xia Shi1, Shi-Yan Yan1, Li-Qiong Wang12, Cun-Zhi Liu1. 1. Acupuncture Research Center, School of Acupuncture-Moxibustion and Tuina, Beijing University of Chinese Medicine, No. 11, Bei San Huan Dong Lu, Chaoyang District, Beijing, 100029, China. 2. Dongzhimen Hospital Affiliated to Beijing University of Chinese Medicine, Beijing University Cardiology Research Institute of Traditional Chinese Medicine, Beijing, 100700, China. 3. Department of Cardiology, Peking University People's Hospital, Beijing, 100044, China. 4. National Clinical Research Center for Chinese Medicine Acupuncture and Moxibustion, First Teaching Hospital, Tianjin University of Traditional Chinese Medicine, Tianjin, 300193, China. 5. Department of Acupuncture and Moxibustion, The First Affiliated Hospital of Nanjing Medical University, Nanjing, 210029, China. 6. Department of Cardiology, Dongzhimen Hospital Affiliated to Beijing University of Chinese Medicine, Beijing, 100700, China. 7. Department of Cardiology, Tianjin First Center Hospital, Tianjin, 300192, China. 8. Department of Cardiology, The First Affiliated Hospital of Nanjing Medical University, Nanjing, 210029, China. 9. Department of Traditional Chinese Medicine, Peking University People's Hospital, Beijing, 100044, China. 10. Department of Acupuncture and Moxibustion, Dongzhimen Hospital Affiliated to Beijing University of Chinese Medicine, Beijing, 100700, China. 11. Department of Acupuncture and Moxibustion, Beijing Hospital of Traditional Chinese Medicine Affiliated to Capital Medical University, Beijing, 100010, China. 12. Acupuncture Research Center, School of Acupuncture-Moxibustion and Tuina, Beijing University of Chinese Medicine, No. 11, Bei San Huan Dong Lu, Chaoyang District, Beijing, 100029, China. wangliqiongwork@163.com.
Abstract
BACKGROUND: Atrial fibrillation (AF) is a common arrhythmia, which is closely related to cardiovascular morbidity and mortality. Although acupuncture is used in the treatment of AF, the evidence is insufficient. The objective of this pilot trial is to evaluate the feasibility, preliminary efficacy, and safety of acupuncture in reducing AF burden for persistent AF after catheter ablation (CA). METHODS AND DESIGN: This will be a multi-center, 3-arm, pilot randomized controlled trial in China. Sixty patients in total will be randomly assigned to the specific acupoints group, the non-specific acupoints group, or the non-acupoints group in a 1:1:1 ratio. The whole study period is 6 months, including a 3-month treatment period and a 3-month follow-up period. All patients will receive 18 sessions of acupuncture over 12 weeks after CA and appropriate post-ablation routine treatment. The primary outcome is AF burden at 6 months after CA measured by electrocardiography patch that can carry out a 7-day continuous ambulatory electrocardiographic monitoring. The secondary outcomes include AF burden at 3 months after CA, recurrence of AF, quality of life, etc. The adverse events will also be recorded. DISCUSSION: This pilot study will contribute to evaluating the feasibility, preliminary efficacy, and safety of acupuncture in reducing AF burden for persistent AF after CA. The results will be used for the sample size calculation of a subsequent large-scale trial. TRIAL REGISTRATION: Chinese Clinical Trial Registry ChiCTR2000030576 . Registered on 7 March 2020.
RCT Entities:
BACKGROUND:Atrial fibrillation (AF) is a common arrhythmia, which is closely related to cardiovascular morbidity and mortality. Although acupuncture is used in the treatment of AF, the evidence is insufficient. The objective of this pilot trial is to evaluate the feasibility, preliminary efficacy, and safety of acupuncture in reducing AF burden for persistent AF after catheter ablation (CA). METHODS AND DESIGN: This will be a multi-center, 3-arm, pilot randomized controlled trial in China. Sixty patients in total will be randomly assigned to the specific acupoints group, the non-specific acupoints group, or the non-acupoints group in a 1:1:1 ratio. The whole study period is 6 months, including a 3-month treatment period and a 3-month follow-up period. All patients will receive 18 sessions of acupuncture over 12 weeks after CA and appropriate post-ablation routine treatment. The primary outcome is AF burden at 6 months after CA measured by electrocardiography patch that can carry out a 7-day continuous ambulatory electrocardiographic monitoring. The secondary outcomes include AF burden at 3 months after CA, recurrence of AF, quality of life, etc. The adverse events will also be recorded. DISCUSSION: This pilot study will contribute to evaluating the feasibility, preliminary efficacy, and safety of acupuncture in reducing AF burden for persistent AF after CA. The results will be used for the sample size calculation of a subsequent large-scale trial. TRIAL REGISTRATION: Chinese Clinical Trial Registry ChiCTR2000030576 . Registered on 7 March 2020.
Authors: An-Wen Chan; Jennifer M Tetzlaff; Peter C Gøtzsche; Douglas G Altman; Howard Mann; Jesse A Berlin; Kay Dickersin; Asbjørn Hróbjartsson; Kenneth F Schulz; Wendy R Parulekar; Karmela Krleza-Jeric; Andreas Laupacis; David Moher Journal: BMJ Date: 2013-01-08
Authors: John Spertus; Paul Dorian; Rosemary Bubien; Steve Lewis; Donna Godejohn; Matthew R Reynolds; Dhanunjaya R Lakkireddy; Alan P Wimmer; Anil Bhandari; Caroline Burk Journal: Circ Arrhythm Electrophysiol Date: 2010-12-15
Authors: Puja K Mehta; Donna M Polk; Xiao Zhang; Ning Li; Jeannette Painovich; Kamlesh Kothawade; Joan Kirschner; Yi Qiao; Xiuling Ma; Yii-Der Ida Chen; Anna Brantman; Chrisandra Shufelt; Margo Minissian; C Noel Bairey Merz Journal: Int J Cardiol Date: 2014-07-11 Impact factor: 4.164