Zhao Ling, Li Dehua, Zheng Hui, Chang Xiaorong, Cui Jin, Wang Ruihui, Shi Jing, Fan Hailong, Li Ying, Sun Xin, Zhang Fuwen, Wu Xi, Liang Fanrong
Acupuncture and Tuina School, Chengdu University of Traditional Chinese Medicine, Chengdu, Sichuan, China.
Department of Acupuncture, the Hospital of Chengdu University of Traditional Chinese Medicine, Chengdu, Sichuan, China.
JAMA Intern Med. 2019 Oct 1;179(10):1388-1397. doi: 10.1001/jamainternmed.2019.2407.
The effects of acupuncture as adjunctive treatment to antianginal therapies for patients with chronic stable angina are uncertain.
To investigate the efficacy and safety of acupuncture as adjunctive therapy to antianginal therapies in reducing frequency of angina attacks in patients with chronic stable angina.
DESIGN, SETTING, AND PARTICIPANTS: In this 20-week randomized clinical trial conducted in outpatient and inpatient settings at 5 clinical centers in China from October 10, 2012, to September 19, 2015, 404 participants were randomly assigned to receive acupuncture on the acupoints on the disease-affected meridian (DAM), receive acupuncture on the acupoints on the nonaffected meridian (NAM), receive sham acupuncture (SA), and receive no acupuncture (wait list [WL] group). Participants were 35 to 80 years of age with chronic stable angina based on the criteria of the American College of Cardiology and the American Heart Association, with angina occurring at least twice weekly. Statistical analysis was conducted from December 1, 2015, to July 30, 2016.
All participants in the 4 groups received antianginal therapies as recommended by the guidelines. Participants in the DAM, NAM, and SA groups received acupuncture treatment 3 times weekly for 4 weeks for a total of 12 sessions. Participants in the WL group did not receive acupuncture during the 16-week study period.
Participants used diaries to record angina attacks. The primary outcome was the change in frequency of angina attacks every 4 weeks from baseline to week 16.
A total of 398 participants (253 women and 145 men; mean [SD] age, 62.6 [9.7] years) were included in the intention-to-treat analyses. Baseline characteristics were comparable across the 4 groups. Mean changes in frequency of angina attacks differed significantly among the 4 groups at 16 weeks: a greater reduction of angina attacks was observed in the DAM group vs the NAM group (difference, 4.07; 95% CI, 2.43-5.71; P < .001), in the DAM group vs the SA group (difference, 5.18; 95% CI, 3.54-6.81; P < .001), and in the DAM group vs the WL group (difference, 5.63 attacks; 95% CI, 3.99-7.27; P < .001).
Compared with acupuncture on the NAM, SA, or no acupuncture (WL), acupuncture on the DAM as adjunctive treatment to antianginal therapy showed superior benefits in alleviating angina.
ClinicalTrials.gov identifier: NCT01686230.
针刺作为慢性稳定型心绞痛患者抗心绞痛治疗辅助手段的效果尚不确定。
探讨针刺作为抗心绞痛治疗辅助疗法在降低慢性稳定型心绞痛患者心绞痛发作频率方面的疗效和安全性。
设计、地点和参与者：本为期20周的随机临床试验于2012年10月10日至2015年9月19日在中国5个临床中心的门诊和住院部进行，404名参与者被随机分配接受病侧经络穴位针刺（DAM组）、非病侧经络穴位针刺（NAM组）、假针刺（SA组）以及不接受针刺（等待列表[WL]组）。参与者年龄在35至80岁之间，符合美国心脏病学会和美国心脏协会标准的慢性稳定型心绞痛患者，心绞痛每周至少发作两次。统计分析于2015年12月1日至2016年7月30日进行。
4组所有参与者均按照指南推荐接受抗心绞痛治疗。DAM组、NAM组和SA组参与者每周接受3次针刺治疗，共4周，总计12次。WL组参与者在16周的研究期间不接受针刺治疗。
参与者使用日记记录心绞痛发作情况。主要结局是从基线到第16周每4周心绞痛发作频率的变化。
意向性分析纳入了总共398名参与者（253名女性和145名男性；平均[标准差]年龄，62.6[9.7]岁）。4组基线特征具有可比性。在第16周时，4组心绞痛发作频率的平均变化存在显著差异：与NAM组相比，DAM组心绞痛发作减少更明显（差异为4.07；95%置信区间，2.43 - 5.71；P < .001），与SA组相比（差异为5.18；95%置信区间，3.54 - 6.81；P < .001），与WL组相比（差异为5.63次发作；95%置信区间，3.99 - 7.27；P < .001）。
与NAM组针刺、SA组针刺或不针刺（WL组）相比，病侧经络穴位针刺作为抗心绞痛治疗的辅助手段在缓解心绞痛方面显示出更优的效果。
ClinicalTriTriTri.gov标识符：NCT01686230。
