Acupoint application in patients with chronic stable angina pectoris: study protocol of a randomized, double-blind, controlled trial

Yulan Ren, Dehua Li, Hui Zheng, Junling Lv, Junyan Leng, Linglin Zhang, Jie Zhang, Hailong Fan, Fanrong Liang, Yulan Ren, Dehua Li, Hui Zheng, Junling Lv, Junyan Leng, Linglin Zhang, Jie Zhang, Hailong Fan, Fanrong Liang

Abstract

Background. Chronic stable angina pectoris (CSAP) is a major syndrome of ischemic heart disease (IHD). CSAP manifests as chest pain or discomfort and affects patients' quality of life. Acupoint application (AP) has been reported to be effective for managing the symptoms of CSAP, but the evidence is not convincing. Therefore, we designed a randomized, double-blind, placebo-controlled clinical trial to evaluate the efficacy of AP in the treatment of CSAP. Methods and Analysis. Two hundred participants with CSAP will be randomly assigned in a 1 : 1 : 1 : 1 ratio into 4 groups. All participants will receive 12 sessions of treatment in 4 weeks and the same basic treatment procedure. The participants will be visited and assessed for 12 weeks, including a 4-week screening, a 4-week treatment phase, and a 4-week follow-up phase. The primary outcome is the change in the total frequency of self-reported angina attack at 4th week compared with the baseline. The secondary outcomes include the intensity of angina pain, consumption of nitroglycerin or Suxiao Jiuxin pills, CCS angina classification, SAQ, SAS and SDS score. Ethics. The study protocol has been reviewed and approved by the Sichuan Regional Ethics Review Committee on TCM (number 2013kl-001). This trial is registered with clinicaltrials.gov NCT02029118.

Figures

Figure 1
Figure 1
Study design.
Figure 2
Figure 2
Diagram of acupoints location.

References

    1. Lopez AD, Mathers CD, Ezzati M, Jamison DT, Murray CJ. Global and regional burden of disease and risk factors, 2001: systematic analysis of population health data. The Lancet. 2006;367(9524):1747–1757.
    1. Daly CA, de Stavola B, Fox KM. Predicting prognosis in stable angina-results from the Euro heart survey of stable angina: prospective observational study. The British Medical Journal. 2006;332(7536):262–267.
    1. Fox K, Alonso Garcia MA, Ardissino D, et al. Guidelines on the management of stable angina pectoris: Executive summary: The Task Force on the Management of Stable Angina Pectoris of the European Society of Cardiology. European Heart Journal. 2006;27(11):1341–1381.
    1. Tarkin JM, Kaski JC. Pharmacological treatment of chronic stable angina pectoris. Clinical Medicine. 2013;13(1):63–70.
    1. Fraker TD, Fihn SD. 2007 chronic angina focused update of the ACC/AHA 2002 guidelines for the management of patients with chronic stable angina: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines Writing Group to develop the focused update of the 2002 guidelines for the management of patients with chronic stable angina. Journal of the American College of Cardiology. 2007;50(23):2264–2274.
    1. Münzel T, Gori T. Nitrate therapy and nitrate tolerance in patients with coronary artery disease. Current Opinion in Pharmacology. 2013;13(2):251–259.
    1. Prasad K, Sharma V, Lackore K, Jenkins SM, Prasad A, Sood A. Use of complementary therapies in cardiovascular disease. American Journal of Cardiology. 2013;111(3):339–345.
    1. Chu FY, Yan X, Zhang Z, et al. Features of complementary and alternative medicine use by patients with coronary artery disease in Beijing: a cross-sectional study. BMC Complementary and Alternative Medicine. 2013;13(1, article 287)
    1. Prausnitz MR, Langer R. Transdermal drug delivery. Nature Biotechnology. 2008;26(11):1261–1268.
    1. Fan ZC, Li MY, Xi ZL, et al. Observation on therapeutic effects of angina pectoris treated with acupoint-application. Chinese Acupuncture & Moxibustion. 1997;(9):527–577.
    1. Yin JM, Luo LY, Zhang DC, et al. Clinical study on acupoint application by tongxintie plaster on patients with angina pectoris. Chinese Journal of Integrative Medicine on Cardio/Cerebrovascular Disease. 2009;7(10):1138–1140.
    1. Liu Y, Wang T, Zhang J. Treatment of angina pectoris with medicinal plaster fixed at acupoints—a report of 54 cases. Journal of Traditional Chinese Medicine. 1998;18(1):12–14.
    1. Liu JL, Luo MF, Wang ZY, et al. Effects of acupoint-application on cardiac performance, myocardial metabolism and structural changes in myocardial ischemia rabbits. Chinese Journal of Natural Medicine. 2005;(3):41–45.
    1. China Society of Cardiology. Chronic stable angina pectoris diagnosis and treatment guidelines. Chinese Journal of Cardiology. 2007:195–206.
    1. Li CX, Ding F, Wang L, et al. Research of protection of new GuanxinSuhe dripping pill on experiment myocardial ischemia. Liaoning Journal of Traditional Chinese Medicine. 2012;39(5):771–773.
    1. Xu C, Suo DQ, Cao YL. The effects of Guanxinsuhe soft capsules on acute myocardial ischemia in dogs. Journal of Shenyang Pharmaceutical University. 2001;18(5):373–375.
    1. Zhang JY, Li YK, Ma K, et al. Effects of series of Muskone on cardiomyocytes suffering from hypoxia- reoxygenation injury. Chinese Journal of New Drug. 2007;16:1481–1484.
    1. Zhang X, Song JQ, Wang Y, et al. Mechanism of GuanxinSuhe-containing serum against apoptosis of cardiomyocytes induced by hydrogen peroxide. Chinese Traditional Patent Medicine. 2013;35(2):232–236.
    1. Zhang JR. Treatment of angina pectoris guanxin suhexiang capsules—a report of 40 cases. Modern Journal of Integrated Traditional Chinese and Western Medicine. 2003;12(17, 1859)
    1. He DF, Ren YL, Tang Y, et al. Application of data-mining to analyze characteristics of meridians and acupoints selected for acu-moxibustion treatment of chest blockage in ancient literatures of different periods of ancient days. Liaoning Journal of Traditional Chinese Medicine. 2013;40(6):1209–1213.
    1. Lim S. WHO standard acupuncture point locations. Evidence-Based Complementary and Alternative Medicine. 2010;7(2):167–168.
    1. Lin Y, Ji F, Huang GR, Li P. Our considerations about non-acupoint selection for experimental studies in rats. Zhen Ci Yan Jiu. 2013;38(4):334–338.
    1. Duan X, Zhou L, Wu T, et al. Chinese herbal medicine suxiao jiuxin wan for angina pectoris. Cochrane Database of Systematic Reviews. 2008;23(1)CD004473
    1. Fu XG. Acupoint application in treating angina pectoris combined with Yiqihuoxue decoction—a report of 42 cases. Guiding Journal of Traditional Chinese Medicine and Pharmacology. 2012;18(10):67–68.
    1. Wu YH, Dong B. Discussion on prevention and treatment of acupoint application in treating angina pectoris. Liaoning Journal of Traditional Chinese Medicine. 2013;40(9):1891–1892.
    1. Yu CY, Yu B. Acupoint application with herbal medicine in treating coronary heart disease—a report of 420 cases. Chinese Acupuncture & Moxibustion. 1990;(5):5–6.
    1. Li DY, Gao CX. The effect of Guanxi plaster on blood viscosity in patients with angina pectoris. LiShiZhen Medicine and Materia Medica Research. 2006;17(11):p. 2272.
    1. Liu JJ. Clinical observation of unstable angina pectoris with coronary heart disease (Qi Deficiency blood stagnation syndrome) by using Angina pectoris pastes. Liaoning Journal of Traditional Chinese Medicine. 2011;38(4):662–663.
    1. Jiang AP, Xie RY, Li X, et al. Clinical study on acupoint application with herbal medicine for angina pectoris. Chinese Journal of Information on TCM. 2003;10(1):41–42.
    1. Jin HG, Qi F, Zhao M. Clinical study on acupoint application in treating stable angina pectoris compared with acupuncture. Journal of Changchun University of Traditional Chinese Medicine. 2013;29:523–524.
    1. Dai JY, Wang ZF, Li D. Clinical study of acupoint application with Danqiyixin plaster in treating angina pectoris. Chinese Acupuncture & Moxibustion. 1997;(10):588–590.
    1. Feng L, Han T, Zhou YL. The conclusion of the clinic effect for Suxiao Jiuxin Wan for CHD and angina pectoris. Journal of Emergency Syndromes in Chinese Medicine. 2000;9(1):4–6.
    1. Zhuang ZQ, Wan Y, Zhang Q, Yao GY, Feng GQ. Curative effect observing of Suxiao jiuxin wan for no symptom myocardial infractiono of coronary heart disease 48 cases. Modern Journal of Integrated Chinese Traditional and Western Medicine. 1999;8(11):1781–1782.
    1. Yuan G. Curative effect observions on Suxiao jiuxin wan compared to Xiao xin tong for Angina pectoris. Medical Journal of Healing of Heart and Vessel. 2002;9(9):71–72.
    1. Wei J, Tang Y. Comparing research on the clinical effect of Suxiao Jiuxin Wan for ischemic heart disease. Journal of Emergency Syndromes in Chinese Medicine. 1995;164(4):159–160.

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