Effectiveness and Safety of Acupoint Application of Guan Xin Su He Pill (冠心苏合丸) for Patients with Chronic Stable Angina Pectoris: A Multi-Center, Randomized Controlled Trial<sup>*</sup>

De-hua LI; Jin XIE; Yu-lan REN; Hui ZHENG; Jun-ling LYU; Jun-yan LENG; Ling-lin ZHANG; Jie ZHANG; Hai-long FAN; Fan-rong LIANG

doi:10.1007/s11655-021-2870-3

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Effectiveness and Safety of Acupoint Application of Guan Xin Su He Pill (冠心苏合丸) for Patients with Chronic Stable Angina Pectoris: A Multi-Center, Randomized Controlled Trial^*

Acupuncture Research | Updated：2021-11-05

- Effectiveness and Safety of Acupoint Application of Guan Xin Su He Pill (冠心苏合丸) for Patients with Chronic Stable Angina Pectoris: A Multi-Center, Randomized Controlled Trial^*
- Effectiveness and Safety of Acupoint Application of Guan Xin Su He Pill (冠心苏合丸) for Patients with Chronic Stable Angina Pectoris: A Multi-Center, Randomized Controlled Trial^*
- Chinese Journal of Integrative Medicine 2021年27卷第11期页码：838-845
- Affiliations：
  
  1.Department of Acupuncture and Moxibustion, Hospital of Chengdu University of Traditional Chinese Medicine, Chengdu(610075), China
  2.Acupuncture and Tuina School, Chengdu University of Traditional Chinese Medicine, Chengdu (610075), China
- Author bio：
  
  Prof. LIANG Fan-rong, E-mail:acuresearch@126.com
- Funds：
  
  the State Key Program for Basic Research of China(2012CB518501);the Research Program of the Science and Technology Ministry of the Chengdu City in China(12DXYB215JH002)
- DOI：10.1007/s11655-021-2870-3
  中图分类号：
- 纸质出版日期：2021-11-01，
  
  网络出版日期：2021-08-13，
  
  录用日期：2020-04-02
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De-hua LI, Jin XIE, Yu-lan REN, 等. Effectiveness and Safety of Acupoint Application of Guan Xin Su He Pill (冠心苏合丸) for Patients with Chronic Stable Angina Pectoris: A Multi-Center, Randomized Controlled Trial^*[J]. Chinese Journal of Integrative Medicine, 2021,27(11):838-845.

De-hua LI, Jin XIE, Yu-lan REN, et al. Effectiveness and Safety of Acupoint Application of Guan Xin Su He Pill (冠心苏合丸) for Patients with Chronic Stable Angina Pectoris: A Multi-Center, Randomized Controlled Trial^*[J]. Chinese Journal of Integrative Medicine, 2021,27(11):838-845.
De-hua LI, Jin XIE, Yu-lan REN, 等. Effectiveness and Safety of Acupoint Application of Guan Xin Su He Pill (冠心苏合丸) for Patients with Chronic Stable Angina Pectoris: A Multi-Center, Randomized Controlled Trial^*[J]. Chinese Journal of Integrative Medicine, 2021,27(11):838-845. DOI： 10.1007/s11655-021-2870-3.

De-hua LI, Jin XIE, Yu-lan REN, et al. Effectiveness and Safety of Acupoint Application of Guan Xin Su He Pill (冠心苏合丸) for Patients with Chronic Stable Angina Pectoris: A Multi-Center, Randomized Controlled Trial^*[J]. Chinese Journal of Integrative Medicine, 2021,27(11):838-845. DOI： 10.1007/s11655-021-2870-3.

摘要

目的:

评价冠心苏和丸穴位贴敷治疗慢性稳定型心绞痛患者的临床疗效.

方法:

本研究在中国成都的3家医院进行. 基线评估后

符合纳入标准的患者被随机分配到安慰剂穴位贴敷组 (PAA组) 或中药穴位贴敷组 (HAA组) . HAA组患者给予以冠心苏和丸为主的中药粉末调制的穴位贴敷治疗

PAA组患者给予以荞麦粉为主调制的安慰剂贴敷治疗. 两组均取内关穴 (PC 6) 、膻中穴 (RN 17) 、心俞穴 (BL 15) 和厥阴俞穴 (BL 14) 治疗

每次贴敷均取单侧穴位

两侧交替

每周进行3次穴位贴敷

每次间隔2天

持续4周. 主要评价指标为每周心绞痛发作的次数

次要评价指标包括疼痛视觉模拟量表 (VAS) 测量每次心绞痛疼痛程度、口服硝酸甘油的剂量、西雅图心绞痛问卷量表 (SAQ)

焦虑自评量表 (SAS) 和抑郁自评量表 (SDS) . 以上指标在入组第0、4和8周评定

同时评价冠心苏和丸穴位贴敷治疗慢性稳定型心绞痛的安全性.

结果:

共纳入121例患者

两组的基线特征具有可比性. 治疗后

HAA组的心绞痛发作次数从11.00次减少至4.81次 (

0.05)

PAA组心绞痛发作次数没有显著变化 (基线值10.55; 治疗后11.05)

HAA组的心绞痛发作明显少于PAA组 (

0.05) ; HAA组VAS测量的疼痛强度从4.06降低至3.02 (

0.05)

而PAA组VAS评分增加 (基线3.62

治疗后3.96) (

0.05) ; 口服硝酸甘油的剂量、SAS、SDS和SAQ评分方面

HAA组治疗后的改善优于PAA组 (

0.05) ; 少数患者发生皮肤过敏等轻微不良反应发生.

结论:

冠心苏和丸穴位贴敷是慢性稳定型心绞痛患者安全有效的治疗方法. (临床注册号NCT02029118)

Abstract

Objective:

To assess the clinical effectiveness of acupoint application (AP) of Guan Xin Su He Pill (冠心苏合丸

GXSHP) for patients with chronic stable angina pectoris (CSAP).

Methods:

This study was carried out in 3 local hospitals in Chengdu

China. After baseline evaluation

eligible patients were randomly assigned to the placebo application for acupoints (PAA) group or the herbal application for acupoints (HAA) group. Patients in the HAA group underwent AP with herbal powder

which was mainly GXSHP

and patients in the PAA group underwent AP with sham drugs. For each treatment session

unilateral acupoints including Neiguan (PC 6)

Danzhong (RN 17)

Xinshu (BL 15) and Jueyinshu (BL 14)

were stimulated for both groups. AP was performed 3 times a week with a 2-day interval for 4 weeks. The primary outcome was the frequency of angina pectoris attacks per week

while the secondary outcomes included angina pain intensity measured by the Visual Analogue Scale (VAS)

dose of rescue oral drugs (nitroglycerin)

scores on the Seattle Angina Questionnaire (SAQ)

Self-Rating Anxiety Scale scores (SAS) and Self-Rating Depression Scale scores (SDS). Clinical outcomes were measured at week 0

4 and 8. The safety of AP of GXSHP treatment for CSAP were assessed.

Results:

A total of 121 patients were enrolled. Baseline characteristics were comparable across the 2 groups. After treatment

the angina attack numbers in the HAA group were significantly reduced from 11.00 to 4.81 (

0.05). While

for PAA group

the angina frequency was not significantly improved (baseline 10.55; post-treatment 11.05). The HAA group had significantly fewer angina attacks than the PAA group (

0.05). Pain intensity measured by VAS in HAA group was significantly reduced from 4.06 to 3.02 (

0.05). While

for PAA group

the VAS was significantly increased (baseline 3.62; post-treatment 3.96;

0.05). Clinical outcomes showed better improvement after treatment in the HAA group than in the PAA group in terms of oral administration of rescue drugs

SAS

SDS and SAQ scores (

0.05). The adverse events were also reported.

Conclusion:

AP of GXSHP is a safe and effective treatment for CSAP patients (Registration No. NCT02029118).

关键词

Keywords

acupoint applicationchronic stable angina pectorisclinical efficacy randomized controlled trial

references

Fox K, García MA, Ardissino D, Buszman D, Camici PG, Crea F, et al. Guidelines on the management of stable angina pectoris. Executive summary. Rev Esp Cardiol 2006;59:919-970.

Benjamin EJ, Virani SS, Callaway CW, Chamberlain AM, Chang AR, Cheng S, et al. Heart disease and stroke statistics-2018 update: a report from the American Heart Association. Circulation 2018;137:e67-e492.

Chen WW, Gao RL, Liu LS, Zhu ML, Wang W, Wang YJ, et al. Summary of China cardiovascular disease report 2016.Chin Circulation J (Chin) 2017;32:521-530.

Health NIH. Morbidity and mortality: 2012 chart book on cardiovascular, lung, and blood diseases. National Insitutes Health 2012:116.

Montalescot G, Sechtem U, Achenbach S, Andreotti F, Arden C, Budaj A, et al. 2013 ESC guidelines on the management of stable coronary artery disease: the task force on the management of stable coronary artery disease of the european society of cardiology. Eur Heart J 2013;34:2949-3003.

Richard KJVH, Management R. Recent advances in the management of chronic stable angina Ⅰ: approach to the patient, diagnosis, pathophysiology, risk stratification, and gender disparities. Vasc Health Risk Manag 2010;6:635-656.

Thadani U. Nitrate tolerance, rebound, and their clinical relevance in stable angina pectoris, unstable angina, and heart failure. Cardiovascular Drugs Therapy 1997;10:735-742.

Psaty BM, Koepsell TD, Wagner EH, Logerfo JP, Inui TS. The relative risk of incident coronary heart disease associated with recently stopping the use of beta-blockers.JAMA 1990;35:1653-1657.

Jr FT, Fihn SD, Gibbons RJ, Abrams J, Chatterjee K, Daley J, et al. 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. J Am Coll Cardiol 2007;50:2264-2274.

Daly CA, De Stavola B, Sendon JL, Tavazzi L, Boersma E, Clemens F, et al. Predicting prognosis in stable angina-results from the Euro heart survey of stable angina:prospective observational study. BMJ 2006;332:262-265.

Chen J, Ren Y, Tang Y, Li Z, Liang FR. Acupuncture therapy for angina pectoris: a systematic review. J Tradit Chin Med 2012;32:494-501.

Zhang LL, Leng JY, Zhang J, Li DH, Zhao L, Liang FR.Randomized controlled trials of the point application therapy for stable angina pectoris: a systematic analysis. J Chongqing Med Univ (Chin) 2015;40:527-532.

Yin JM, Luo LY, Zhang DC, Li G. Clinical study on acupoint application by Tongxintie Plaster on patients with angina pectoris. Chin J Integr Med Cardio-/Cerebrovascul Dis(Chin) 2009;7:1138-1140.

Liu Y, Wang T, Zhang J. Treatment of angina pectoris with medicinal plaster fixed at acupoints–a report of 54 cases. J Tradit Chin Med 1998;18:12-14.

LI H, Wang SJ. Study on mechanism of acupoint application in disease prevention and control. J Pract Tradit Chin Intern Med (Chin) 2016;30:117-118.

Ren Y, Li D, Zheng H, Lv J, Leng J, Zhang L, et al.Acupoint application in patients with chronic stable angina pectoris: study protocol of a randomized, double-blind, controlled trial. Evidence-Based Complement Altern Med 2014;2014:619706.

Fihn SD, Blankenship JC, Alexander KP, Bittl JA, Byrne JG, et al. 014 ACC/AHA/AATS/PCNA/SCAI/STS focused update of the guideline for the diagnosis and management of patients with stable ischemic heart disease: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines, and the American Association for Thoracic Surgery, Preventive Cardiovascular Nurses Association, Society for Cardiovascular Angiography and Interventions, and Society of Thoracic Surgeons. J Am Coll Cardiol 2014;64:1929-1949.

The Editorial Board of Chinese Medical Association of Cardiology and the Chinese Society of Cardiology. Chronic stable angina pectoris diagnosis and treatment guidelines.Chin J Cardiol (Chin) 2007;35:195-206.

He DF, Ren YL, Tang Y, Liang FR. 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 J Tradit Chin Med (Chin) 2013;40:1209-1213.

Lim S. WHO standard acupuncture point locations. Evid Based Complement Altern Med 2010;7:167-168.

Wang M, Chen H, Lu S, Wang J, Zhu B. Impacts on neutrophil to lymphocyte ratio in patients of chronic stable angina pectoris treated with acupuncture at Neiguan (PC 6). Chin Acupunct Moxibust 2015;35:417-421.

Spertus JA, Winder JA, Dewhurst TA, Deyo RA, Prodzinski J, McDonnell M, et al. Development and evaluation of the Seattle Angina Questionnaire: a new functional status measure for coronary artery disease. J Am Coll Cardiol 1995;25:333-341.

Zung WW, Richards CB, Short MJ. Self-rating depression scale in an outpatient clinic. Further validation of the SDS.Arch Gen Psychiatry 1965;13:508-515.

Skalidis EI, Vardas PE. Guidelines on the management of stable angina pectoris. Eur Heart J 2006;27:2606-2607.

Tarkin JM, Kaski JC. Pharmacological treatment of chronic stable angina pectoris. Clin Med (Lond) 2013;13:63-70.

O'Rourke RA. Alternative strategies for the management of chronic stable angina. Curr Probl Cardiol 2010;35:384-446.

Prasad K, Sharma V, Lackore K, Jenkins SM, Prasad A, Sood A. Use of complementary therapies in cardiovascular disease. Am J Cardiol 2013;111:339-345.

Cai Y, Peng CX. Meta analysis on acupuncture treatment of diabetes. Chin Archives Tradit Chin Med (Chin)2010;28:2412-2415.

Zhao R, Fu LX, Xiong J, Sheng LI, Wang ZL. The effect of acupuncture therapy on essential hypertension:a systematic review of long-term effect. J Clin Acupunct Moxibust (Chin)2011;27:46-51.

Zhang BZ, Zhang K, Liu YZ. Meta analysis on RCTs of acupuncture and moxibustion at fenglong point for treatment of hyperlipemia. Chin J Inform Tradit Chin Med(Chin) 2014;21:11-15.

Yang XB, Liao JF, Hu XW. Clinical study on treatment of 96 cases of asthma with Xiaoqinglong decoction combined with acupoint application. Lishizhen Med Mater Med Res(Chin) 2010;21:1555-1556.

Zheng LL, Zhou Z, Liu K. Treatment of 36 cases of children's night cry with Chinese medicine Yongquan acupoint application. Med Inform (Chin) 2010;23:3631-3632.

Xiaohui YU, Wang J, Medicine W. Efficacy of acupoint plastering therapy with Wenjing Zhitong Paste for 32 cases with primary dysmenorrhea. Res Integr Tradit Chin West Med (Chin) 2010;2:175-177.

He YP, Xiao XQ, Deng GM, Ouyang LQ, Chen Z, Zhang ZG.Research review of functional mechanism of treatment by way of pasting traditional Chinese medicine on acupoints.Chin J Inform Tradit Chin Med (Chin) 2017;24:134-136.

Liu JL, Luo MF, Wang ZY. Effects of acupoint-application on cardiac performance, myocardial metabolism and structural changes in myocardial ischemia rabbits. Chin J Natur Med (Chin) 2005;7:217-221.

Liu JJ. Clinical observation of unstable angina pectoris with coronary heart disease (qi deficiency blood stagnation syndrome) by using angina pectoris pastes. Liaoning J Tradit Chin Med (Chin) 2011;38:662-663.

Münzel T, Gori T. Nitrate therapy and nitrate tolerance in patients with coronary artery disease. Current Opinion Pharmacol 2013;13:251-259.

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