Acupuncture for chronic, stable angina pectoris and an investigation of the characteristics of acupoint specificity: study protocol for a multicenter randomized controlled trial

Dehua Li, Mingxiao Yang, Ling Zhao, Hui Zheng, Ying Li, Xiaorong Chang, Jin Cui, Ruihui Wang, Jing Shi, Junling Lv, Junyan Leng, Juan Li, Fanrong Liang, Dehua Li, Mingxiao Yang, Ling Zhao, Hui Zheng, Ying Li, Xiaorong Chang, Jin Cui, Ruihui Wang, Jing Shi, Junling Lv, Junyan Leng, Juan Li, Fanrong Liang

Abstract

Background: Chronic stable angina pectoris (CSAP) is a common cardiovascular condition that endangers a patient's life quality and longevity. As demonstrated in several clinical trials, acupuncture is attested to be effective for CSAP. Current trials are not adequate enough to provide high-quality evidence for clinical decision making, as a result of inadequate methodology design and small sample size. Notably, stark controversy toward acupoint specificity also exists in the clinical acupuncture trials for CSAP. Therefore, we designed the present study as a randomized controlled trial primarily to investigate the effectiveness of acupuncture in addition to routine care among patients with CSAP. Meanwhile, we examined whether acupoint on the disease-affected meridian (DAM) is superior to either acupoint on the non-affected meridian (NAM) or non-acupoint (NA), to further investigate the meridian-based characteristics of acupoint specificity.

Methods/design: This study was a multicenter, assessor and statistician blinded, randomized controlled trial in China. In this study, 404 participants in sum will be randomly assigned to four groups through central randomization in a 1:1:1:1 ratio. The whole study period is 20 weeks including a 4-week baseline period, a 4-week treatment period and a 12-week follow-up. Participants in the DAM group receive acupuncture stimulation at acupoints on the disease-affected meridian, and three different control groups will undergo acupuncture stimulation at the NAM, the non-acupoint and no intervention respectively, in addition to basic treatment. Participants in the acupuncture groups will receive 12 sessions of acupuncture treatment over 4 weeks, while the wait-listed (WL) group would receive free acupuncture treatment after the completion of the study. The outcome measures in this trial include the frequency of angina attack during 4 weeks as the primary outcome and eight other secondary outcomes.

Discussion: This trial will provide new and relatively high-quality evidence in acupuncture treatment for CSAP. Moreover, this trial may further validate the meridian-based characteristics of acupoint specificity by comparing the strength of acupoints on the disease-affected meridian versus that of the non-affected meridian, to further inspire optimization of acupuncture therapy for CSAP.

Trial registration: Clinical Trials.gov NCT01686230.

Figures

Figure 1
Figure 1
Trial flow chart.

References

    1. Abrams J. Chronic stable angina. N Engl J Med. 2005;352:2524–2533. doi: 10.1056/NEJMcp042317.
    1. Go AS, Mozaffarian D, Roger VL, Benjamin EJ, Berry JD, Borden WB, Bravata DM, Dai S, Ford ES, Fox CS. Executive Summary: Heart Disease and Stroke Statistics—2013 Update: A Report From the American Heart Association. Circulation. 2013;127:143–152. doi: 10.1161/CIR.0b013e318282ab8f.
    1. Hemingway H, McCallum A, Shipley M, Manderbacka K, Martikainen P, Keskimäki I. Incidence and prognostic implications of stable angina pectoris among women and men. JAMA. 2006;295:1404–1411. doi: 10.1001/jama.295.12.1404.
    1. Lam T, Liu L, Janus E, Lau C, Hedley A. Fibrinogen, angina and coronary heart disease in a Chinese population. Atherosclerosis. 2000;149:443–449. doi: 10.1016/S0021-9150(99)00347-0.
    1. Xu L, Xu H, Gao W, Wang W, Zhang H, Lu DP. Treating angina pectoris by acupuncture therapy. Acupunct Electrother Res. 2013;38:17–35. doi: 10.3727/036012913X13831831849457.
    1. Kang X, Xia Y. Acupuncture Therapy for Neurological Diseases. Berlin Heidelberg: Springer; 2010. Effects of Acupuncture on Arrhythmia and Other Cardiac Diseases; pp. 263–288.
    1. Health NIo. NIH consensus conference: acupuncture. JAMA. 1998;280:1518–1524. doi: 10.1001/jama.280.17.1518.
    1. Richter A, Herlitz J, Hjalmarson A. Effect of acupuncture in patients with angina pectoris. Eur Heart J. 1991;12:175–178. doi: 10.1093/eurheartj/12.suppl_D.175.
    1. Ballegaard S, Meyer C, Trojaborg W. Acupuncture in angina pectoris: does acupuncture have a specific effect? J Intern Med. 1991;229:357–362. doi: 10.1111/j.1365-2796.1991.tb00359.x.
    1. Ballegaard S, Pedersen F, Pietersen A, Nissen V, Olsen N. Effects of acupuncture in moderate, stable angina pectoris: a controlled study. J Intern Med. 1990;227:25–30. doi: 10.1111/j.1365-2796.1990.tb00114.x.
    1. Ballegaard S, Jensen G, Pedersen F, Nissen VH. Acupuncture in severe, stable angina pectoris: a randomized trial. Acta Medica Scandinavica. 1986;220:307–313.
    1. Zhou X, Liu J. [Metrological analysis for efficacy of acupuncture on angina pectoris] Zhongguo Zhong Xi Yi Jie He Za Zhi. 1993;13:212–214. 196.
    1. Y-h TONG, L-m TONG, G-d XU, Wang S, Li Q. Electrical acupuncture in combination with Western Medicine to treat Angina pectoris. Chinese J Rehabi. 2005;5:008.
    1. Li Y, Guo L. Thirty-five cases of stable and exertional angina pectoris treated with acupuncture of supplementing and activating Zongqi. Zhongguo Zhen Jiu. 2013;33:173–174.
    1. Xu F, Wang J. Clinical observation on acupuncture combined with medication for intractable angina pectoris. Zhongguo Zhen Jiu. 2005;25:89.
    1. Meng J. The effects of acupuncture in treatment of coronary heart diseases. J Tradit Chin Med. 2004;24:16–19.
    1. Lihong D, Jie Y, Shouxiang Y. Clinical study on tcm different therapies for treatment of stable angina pectoris. J Tradit Chin Med. 2006;6:028.
    1. Pei-fen C. My Experience about Acupuncture Treatment of 30 Cases of Stable Angina Pectoris. Zhen Ci Yan Jiu. 2005;1:012.
    1. Zhang H, Liu L, Huang G, Zhou L, Wu W, Zhang T, Huang H. Protective effect of electroacupuncture at the Neiguan point in a rabbit model of myocardial ischemia-reperfusion injury. Can J Cardiol. 2009;25:359–363. doi: 10.1016/S0828-282X(09)70095-9.
    1. Yang L, Yang J, Wang Q, Chen M, Lu Z, Chen S, Xiong L. Cardioprotective effects of electroacupuncture pretreatment on patients undergoing heart valve replacement surgery: a randomized controlled trial. The Annals of thoracic surgery. 2010;89:781–786. doi: 10.1016/j.athoracsur.2009.12.003.
    1. Gao J, Fu W, Jin Z, Yu X. Acupuncture pretreatment protects heart from injury in rats with myocardial ischemia and reperfusion via inhibition of the β1 - adrenoceptor signaling pathway. Life Sci. 2007;80:1484–1489. doi: 10.1016/j.lfs.2007.01.019.
    1. Zhou W, Ko Y, Benharash P, Yamakawa K, Patel S, Ajijola OA, Mahajan A. Cardioprotection of electroacupuncture against myocardial ischemia-reperfusion injury by modulation of cardiac norepinephrine release. Am J Physiol Heart Circ Physiol. 2012;302:H1818–H1825. doi: 10.1152/ajpheart.00030.2012.
    1. Huang R, Han S, Qin L, Sun Z. Effect of electroacupuncture pre-treatment on myocardial enzyme levels in recurrent myocardial ischemia rabbits. Zhen Ci Yan Jiu. 2012;37:224.
    1. Shen J. Research on the neurophysiological mechanisms of acupuncture: review of selected studies and methodological issues. J Altern Complement Med. 2001;7:121–127.
    1. Chen J, Ren Y, Tang Y, Li Z, Liang F. Acupuncture therapy for angina pectoris: a systematic review. J Tradit Chin Med. 2012;32:494–501. doi: 10.1016/S0254-6272(13)60061-8.
    1. Shi G-X, Yang X-M, Liu C-Z, Wang L-P. Factors contributing to therapeutic effects evaluated in acupuncture clinical trials. Trials. 2012;13:1–5. doi: 10.1186/1745-6215-13-1.
    1. Zhao L, Chen J, Liu C-Z, Li Y, Cai D-J, Tang Y, Yang J, Liang F-R. A review of acupoint specificity research in China: status quo and prospects. Evid Based Complement Alternat Med. 2012;2012:543943. doi:10.1155/2012/543943.
    1. Langevin HM, Wayne PM, MacPherson H, Schnyer R, Milley RM, Napadow V, Lao L, Park J, Harris RE, Cohen M. Paradoxes in acupuncture research: strategies for moving forward. Evid Based Complement Alternat Med. 2011;2011:180805. doi:10.1155/2011/180805.
    1. Li Y, Zheng H, Witt CM, Roll S, Yu S-g, Yan J, Sun G-j, Zhao L, Huang W-j, Chang X-r. Acupuncture for migraine prophylaxis: a randomized controlled trial. Can Med Assoc J. 2012;184:401–410. doi: 10.1503/cmaj.110551.
    1. Brinkhaus B, Witt CM, Jena S, Linde K, Streng A, Wagenpfeil S, Irnich D, Walther H-U, Melchart D, Willich SN. Acupuncture in patients with chronic low back pain: a randomized controlled trial. Arch Intern Med. 2006;166:450.
    1. Melchart D, Streng A, Hoppe A, Brinkhaus B, Witt C, Wagenpfeil S, Pfaffenrath V, Hammes M, Hummelsberger J, Irnich D. Acupuncture in patients with tension-type headache: randomised controlled trial. BMJ. 2005;331:376–382. doi: 10.1136/bmj.38512.405440.8F.
    1. Berman BM, Lao L, Langenberg P, Lee WL, Gilpin AM, Hochberg MC. Effectiveness of acupuncture as adjunctive therapy in osteoarthritis of the knee: a randomized, controlled trial. Ann Intern Med. 2004;141:901–910. doi: 10.7326/0003-4819-141-12-200412210-00006.
    1. Madsen MV, Gøtzsche PC, Hróbjartsson A. Acupuncture treatment for pain: systematic review of randomised clinical trials with acupuncture, placebo acupuncture, and no acupuncture groups. BMJl. 2009;38:a3115.
    1. Hróbjartsson A, Gøtzsche PC. Is the placebo powerless? An analysis of clinical trials comparing placebo with no treatment. N Engl J Med. 2001;344:1594–1602. doi: 10.1056/NEJM200105243442106.
    1. Hróbjartsson A, Gøtzsche PC. Is the placebo powerless? Update of a systematic review with 52 new randomized trials comparing placebo with no treatment. J Intern Med. 2004;256:91–100. doi: 10.1111/j.1365-2796.2004.01355.x.
    1. Moffet HH. Sham acupuncture may be as efficacious as true acupuncture: a systematic review of clinical trials. J Altern Complement Med. 2009;15:213–216. doi: 10.1089/acm.2008.0356.
    1. King SB, Smith SC, Hirshfeld JW, Jacobs AK, Morrison DA, Williams DO, Feldman TE, Kern MJ, O’Neill WW, Schaff HV. Focused Update of the ACC/AHA/SCAI 2005 Guideline Update for Percutaneous Coronary Intervention A Report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines: 2007 Writing Group to Review New Evidence and Update the ACC/AHA/SCAI 2005 Guideline Update for Percutaneous Coronary Intervention, Writing on Behalf of the 2005 Writing Committee. Circulation. 2008;117:261–295. doi: 10.1161/CIRCULATIONAHA.107.188208.
    1. China Society of Cardiology. Chinese Journal of Cardiology: Chronic stable angina pectoris diagnosis and treatment guidelines. Chin J Cardiol. 2007;35:195–206.
    1. Duan X, Zhou L, Wu T, Liu G, Qiao J, Wei J, Ni J, Zheng J, Chen X, Wang Q. Chinese herbal medicine suxiao jiuxin wan for angina pectoris. Cochrane Database Syst Rev. 2008;23:CD004560.
    1. Lim S. WHO Standard Acupuncture Point Locations. Evid Based Complement Alternat Med. 2010;7:167–168. doi: 10.1093/ecam/nep006.
    1. Hongli C. Neiguan relieye chest pain acute myocardial infarction for 38 cases. Chinese Acupuncture. 2005;25:160.
    1. Du YZ. SHI Xue-min's idea of acupuncture treatment on acute syndromes and intractable diseases. Zhongguo Zhen Jiu. 2010;30:1025–1028.
    1. Deadman P, Baker K, Al-Khafaji M. A Manual of Acupuncture: Point Cards. J Chinese Med Publ. pp. 207–225.
    1. Li Y, Liang F, Yu S, Liu X, Tang Y, Yang X, Tian X, Yan J, Sun G, Chang X, Zheng H, Zhang H, Ma T. Randomized controlled trial to treat migraine with acupuncture: design and protocol. Trials. 2008;9:57. doi: 10.1186/1745-6215-9-57.
    1. Tarkin JM, Kaski JC. Pharmacological treatment of chronic stable angina pectoris. Clin Med. 2013;13:63–70. doi: 10.7861/clinmedicine.13-1-63.
    1. Cummings M. Modellvorhaben Akupunktur–a summary of the ART, ARC and GERAC trials. Acupunct Med. 2009;27:26–30. doi: 10.1136/aim.2008.000281.
    1. Kong J, Kaptchuk TJ, Polich G, Kirsch I, Vangel M, Zyloney C, Rosen B, Gollub R. Expectancy and treatment interactions: A dissociation between acupuncture analgesia and expectancy evoked placebo analgesia. Neuroimage. 2009;45:940–949. doi: 10.1016/j.neuroimage.2008.12.025.
    1. Mao JJ, Armstrong K, Farrar JT, Bowman MA. Acupuncture expectancy scale: development and preliminary validation in China. Explore (NY) 2007;3:372–377. doi: 10.1016/j.explore.2006.12.003.

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