Effect of acupuncture on quality of life in atrial fibrillation: study protocol for a randomised controlled trial
Yu Wang,
Li He,
Lin Wang,
Xian Wang,
Ying Lin,
Guang-Xia Shi,
Cun-Zhi Liu,
Wei-Hua Guo,
Jian-Feng Tu,
Shi-Yan Yan,
Li-Qiong Wang,
He-Wen Li,
Meng-Tong Li,
Bang-Qi Wu,
Zhao-Hui Zhang,
Qing-Yan Zhao,
Xue-Bin Li,
Hao-Lin Zhang,
Xue-Wen Wang,
Hai-Ying Wang
Affiliations
Yu Wang
1 International Acupuncture and Moxibustion Innovation Institute, School of Acupuncture-Moxibustion and Tuina, Beijing University of Chinese Medicine, Beijing, China
Li He
7 The First Affiliated Hospital of Hebei University of Chinese Medicine, Hebei, China
Lin Wang
3 Jiangsu Provincial People`s Hospital, Nanjing, China
Xian Wang
5 Dongzhimen Hospital Affiliated to Beijing University of Chinese Medicine, Beijing, China
Ying Lin
1 International Acupuncture and Moxibustion Innovation Institute, School of Acupuncture-Moxibustion and Tuina, Beijing University of Chinese Medicine, Beijing, China
Guang-Xia Shi
1 International Acupuncture and Moxibustion Innovation Institute, School of Acupuncture-Moxibustion and Tuina, Beijing University of Chinese Medicine, Beijing, China
Cun-Zhi Liu
1 International Acupuncture and Moxibustion Innovation Institute, School of Acupuncture-Moxibustion and Tuina, Beijing University of Chinese Medicine, Beijing, China
Wei-Hua Guo
5 Dongzhimen Hospital Affiliated to Beijing University of Chinese Medicine, Beijing, China
Jian-Feng Tu
1 International Acupuncture and Moxibustion Innovation Institute, School of Acupuncture-Moxibustion and Tuina, Beijing University of Chinese Medicine, Beijing, China
Shi-Yan Yan
1 International Acupuncture and Moxibustion Innovation Institute, School of Acupuncture-Moxibustion and Tuina, Beijing University of Chinese Medicine, Beijing, China
Li-Qiong Wang
1 International Acupuncture and Moxibustion Innovation Institute, School of Acupuncture-Moxibustion and Tuina, Beijing University of Chinese Medicine, Beijing, China
He-Wen Li
1 International Acupuncture and Moxibustion Innovation Institute, School of Acupuncture-Moxibustion and Tuina, Beijing University of Chinese Medicine, Beijing, China
Meng-Tong Li
1 International Acupuncture and Moxibustion Innovation Institute, School of Acupuncture-Moxibustion and Tuina, Beijing University of Chinese Medicine, Beijing, China
Bang-Qi Wu
2 The First Teaching Hospital of Tianjin University of Traditional Chinese Medicine, Tianjin, China
Zhao-Hui Zhang
3 Jiangsu Provincial People`s Hospital, Nanjing, China
Qing-Yan Zhao
4 Renmin Hospital of Wuhan University, Wuhan, China
Xue-Bin Li
6 Peking University People’s Hospital, Beijing, China
Hao-Lin Zhang
8 Peking University Third Hospital, Haidian District, Beijing, China
Xue-Wen Wang
4 Renmin Hospital of Wuhan University, Wuhan, China
Hai-Ying Wang
5 Dongzhimen Hospital Affiliated to Beijing University of Chinese Medicine, Beijing, China
Introduction Atrial fibrillation (AF) is the prevalent cardiac arrhythmia and can significantly impair the quality of life (QoL). Although catheter ablation (CA) is an established treatment for AF,post-procedural complications or perceived inadequate control of AF may diminish the QoL for some patients, potentially even to levels lower than pre-procedure. Preliminary findings from our previous pilot trial indicate that acupuncture may positively influence QoL in AF patients post-CA. This study aims to increase the sample size to evaluate the efficacy of acupuncture as an adjunctive treatment to conventional medical therapy in improving QoL of patients with AF after CA.Methods and design This multicentre randomised clinical trial will be conducted in China. A total of 146 eligible patients will be randomly assigned in a 1:1 ratio to either the acupuncture group or the sham acupuncture group. All patients will receive standard postablation care and undergo 18 sessions of acupuncture/sham acupuncture within 12 weeks following CA, followed by a 9-month follow-up period. The primary outcome is the change in the Atrial Fibrillation Effect on Quality-of-Life (AFEQT) summary score from baseline to months 6 after CA. Secondary outcomes include the changes in the AFEQT subscale scores at months 6, the AFEQT summary and subscale score at months 3 and 12, AF burden, AF recurrence, heart rate variability, number of cardioversions, repeat CA procedures, European Heart Rhythm Association score, number of arrhythmia-related hospitalisations, average heart rate, use of Six-Dimensional Health State Short Form to assess health status, costs incurred by disease treatment, Credibility/Expectancy Questionnaire and blinded assessments. Adverse events will also be meticulously recorded throughout the trial.Ethics and dissemination Ethics approval has been granted by the Ethics Committee of Beijing University of Traditional Chinese Medicine (approval no: 2020BZYLL0802) and seven other subcentres. The findings of the study results will be disseminated through presentations at scientific conferences or publications in peer-reviewed journals.Trial registration number ChiCTR2100049323.