Zhao Long, Song Qingqiao, Wu Huaqin, Wang Yanli, Wu Jiani, Fang Jiliang, Li Zhigang
School of Acupuncture, Moxibustion and Tuina, Beijing University of Chinese Medicine, Beijing 100029, China.
Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing 100053, China.
Evid Based Complement Alternat Med. 2021 Apr 28;2021:6634404. doi: 10.1155/2021/6634404. eCollection 2021.
. Stable angina pectoris with moderate coronary artery lesions is a syndrome caused by coronary artery stenosis, which endangers the quality of life. Previous acupuncture studies have shown effectiveness as a complementary therapy for ischaemic heart disease. However, more clinical evidence is needed for verification, and the mechanism should be investigated, especially involving the functional interactions between the heart and brain. Therefore, we designed a clinical trial to provide more evidence for acupuncture efficacy and its mechanism in ischaemic heart disease. . A total of 80 participants will be randomized to the electroacupuncture group and sham-electroacupuncture group at a ratio of 1 : 1. This trial will be conducted over 8 weeks, including a 2-week screening, 2-week treatment, and 4-week follow-up. All participants will continue to receive similar basic disease treatment procedures before the trial (including lifestyle changes and treatment for standard supportive medications, hypertension, and hyperlipidaemia, such as aspirin, metoprolol succinate, atorvastatin, and sodium fosinopril). Additionally, 12 sessions of acupuncture will be administered during the treatment period. The main outcome is Seattle Angina Questionnaire scores. The other observation indices are the heart rate variability and self-rating anxiety scale and self-rating depression scale scores. To explore mechanisms based on the hypothesis of a correlation between heart and brain function, fMRI scans will be used to detect functional brain changes in 15 patients from each group at baseline and at the end of treatment. Finally, the efficacy of acupuncture will be evaluated, and the HRV and imaging data will be correlated with clinical data to investigate the possible relationships between the brain and heart activity. . This trial will provide evidence for acupuncture as adjuvant therapy for the treatment of stable angina pectoris with moderate coronary artery lesions. The results will shed light on potential mechanisms of heart-brain interactions underlying acupuncture as an adjuvant therapy for treating ischaemic heart disease. Trials registration: Clinical Trial, https://clinicaltrials.gov/ct2/show/ChiCTR1900024937. Registered 4 August 2019, http://www.chictr.org.cn/.
中度冠状动脉病变的稳定型心绞痛是一种由冠状动脉狭窄引起的综合征，危及生活质量。先前的针灸研究表明，针灸作为缺血性心脏病的辅助疗法具有有效性。然而，需要更多的临床证据来验证，并且应该研究其机制，特别是涉及心脏与大脑之间的功能相互作用。因此，我们设计了一项临床试验，为针灸治疗缺血性心脏病的疗效及其机制提供更多证据。
总共80名参与者将按1∶1的比例随机分为电针组和假电针组。本试验将持续8周，包括2周的筛查期、2周的治疗期和4周的随访期。所有参与者在试验前将继续接受类似的基础疾病治疗程序（包括生活方式改变以及标准支持药物、高血压和高脂血症的治疗，如阿司匹林、琥珀酸美托洛尔、阿托伐他汀和福辛普利钠）。此外，在治疗期间将进行12次针灸治疗。主要结局指标为西雅图心绞痛问卷评分。其他观察指标为心率变异性、自评焦虑量表和自评抑郁量表评分。为了基于心脏与大脑功能相关性的假设探索机制，将使用功能磁共振成像扫描在基线和治疗结束时检测每组15名患者的大脑功能变化。最后，将评估针灸的疗效，并将心率变异性和成像数据与临床数据相关联，以研究大脑与心脏活动之间可能的关系。
本试验将为针灸作为中度冠状动脉病变稳定型心绞痛治疗的辅助疗法提供证据。研究结果将阐明针灸作为缺血性心脏病辅助疗法背后心脑相互作用的潜在机制。试验注册：临床试验，https://clinicaltrials.gov/ct2/show/ChiCTR1900024937。于2019年8月4日注册，http://www.chictr.org.cn/ 。
