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Effect and Safety of Guanxinning Tablet (冠心宁片) for Stable Angina Pectoris Patients with Xin (Heart)-Blood Stagnation Syndrome: A Randomized, Multicenter, Placebo-Controlled Trial

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Abstract

Objective

To investigate the effect and safety of Guanxinning Tablet (冠心宁片, GXN) for the treatment of stable angina pectoris patients with Xin (Heart)-blood stagnation syndrome (XBSS).

Methods

One hundred and sixty stable angina pectoris patients with XBSS were randomly assigned to receive GXN (80 cases) or placebo (80 cases, Guanxinning simulation tablets, mainly composed of lactose), 4 tablets (0.38 g/tablet), thrice daily for 12 weeks. After treatment, an exercise stress test (treadmill protocol), Chinese medicine (CM) syndrome score, electrocardiogram (ECG), and nitroglycerin withdrawal rate were evaluated and compared in the patients between the two groups. Meanwhile, adverse events (AEs) were evaluated during the whole clinical trial.

Results

Compared with the control group, the time extension of exercise duration in the GXN group increased 29.28 ±17.67 s after treatment (P>0.05); moreover, the change of exercise duration in the GXN group increased 63.10 ±96.96 s in subgroup analysis (P<0.05). The effective rates of angina pectoris, CM syndrome and ECG as well as nitroglycerin withdrawal rate were 81.33%, 90.67%, 45.76%, and 70.73%, respectively in the GXN group, which were all significantly higher than those in the control group (40.58%, 75.36%, 26.92%, 28.21%, respectively, P<0.05).

Conclusion

GXN was a safe and effective treatment for stable angina pectoris patients with XBSS at a dose of 4 tablets, thrice daily.

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References

  1. Jia Y, Leung SW. Drug efficacy in treating stable angina pectoris: a protocol for network meta-analysis of randomised controlled trials. BMJ Open 2014;4:e005453.

    Article  Google Scholar 

  2. Shang H, Zhang J, Yao C, Liu B, Gao X, Ren M, et al. Qi-shen-yi-qi Dripping Pills for the secondary prevention of myocardial infarction: a randomised clinical trial. Evid Based Complement Alternat Med 2013;2013:738391.

    PubMed  PubMed Central  Google Scholar 

  3. Lin XJ, Chai JG, Dai JM, Shi XP, Shen Y, Zhang WJ. A method and application for establishing the fingerprint of Guanxinning Tablet 2017;CN105158352B.

  4. Chen ML, Wang H, Lin L, Shou QY, Zhou WM, Wang DJ, et al. Effect of Guanxinning Tablet on hemorrheology in aged rats. Lab Anim Comparat Med (Chin) 2006;26:231–233.

    Google Scholar 

  5. Pan YM, Ying HZ, Chen ML, Xu JQ, Zhou WM, Wang H, et al. Effects of Guanxinning Tablet on myocardial oxygen consumption in dogs. Lab Anim Comparat Med (Chin) 2007;27:190–191.

    CAS  Google Scholar 

  6. Wang ML, Pan YM, Jin M, Xu XP, Wang DJ, Ma QX, et al. Establishment of a zebrafish model of thrombosis and the intervention effect of Guanxinning Tablet. Acta Lab Anim Sci Sin (Chin) 2016;24:432–438.

    Google Scholar 

  7. The Society of Cardiovascular, Chinese Medical Association. Guidelines for the diagnosis and treatment of chronic stable angina pectoris. Chin J Cardiol (Chin) 2007;35:195–205.

    Google Scholar 

  8. McGillion M, Arthur HM, Cook A, Carroll SL, Victor JC, L’Allier PL, et al. Management of patients with refractory angina: Canadian Cardiovascular Society/Canadian Pain Society joint guidelines. Canad J Cardiol 2012;28:S20–S41.

    Article  Google Scholar 

  9. Zhang Q, Peng JH, Zhang XN. A clinical study of Safflower Yellow Injection in treating coronary heart disease angina pectoris with Xin-blood stagnation syndrome. Chin J Integr Med 2005;11:222–225.

    Article  Google Scholar 

  10. Bruce RA, Hornsten TR. Exercise stress testing in evaluation of patients with ischemic heart disease. Prog Cardiovasc Dis 1969;11:371–390.

    Article  CAS  Google Scholar 

  11. Association CM. Guideline for diagnosis and treatment of patients with chronic stable angina. Chin J Cardiol (Chin) 2007;35:195–206.

    Google Scholar 

  12. Wang YZ, Wang J, Huang Q. Application of subgroup analysis in drug clinical trial. Chin J Clin Pharmacol (Chin) 2012;28:477–480.

    Google Scholar 

  13. Zheng XY, ed. Guiding principle of clinical research on new drugs of traditional Chinese medicine. Beijing: China Medic-Pharmaceutical Sciences and Technology Publishing Press;2002:77–80.

    Google Scholar 

  14. State Food and Drug Administration. Traditional Chinese medicine, natural medicine treatment of coronary heart disease angina pectoris clinical trials technical guiding principles. Available at http://www.nmpa.gov.cn/WS04/CL2196/323849.html.

  15. Chinese Association of the Integration of Traditional and Western Medicine. Diagnostic criteria of blood-stasis symptom-complex. Chin J Integr Tradit West Med (Chin) 1987;7:129.

    Google Scholar 

  16. Stone PH, Gratsiansky NA, Blokhin A, Huang Z, Meng LX. Antianginal efficacy of ranolazine when added to treatment with amlodipine: the ERICA (Efficacy of Ranolazine in Chronic Angina) trial. J Am Coll Cardiol 2006;48:566–575.

    Article  CAS  Google Scholar 

  17. Shi ZW. Introduction and explanation of the Chinese 2007 guidelines on the diagnosis and treatment of chronic stable angina. Pract J Clin Med (Chin) 2008;5:7–9.

    Google Scholar 

  18. He J, Zhu HB, Zheng JH. Meta-analysis of clinical research literature on method of promoting blood circulation and removing blood-stasis for treatment of coronary heart disease. J Pract Tradit Chin Int Med (Chin) 2014;28:1–5.

    Google Scholar 

  19. Wu JR, Liu S, Zhang XM, Zhang B. Danshen Injection as adjuvant treatment for unstable angina pectoris: a systematic review and meta-analysis. Chin J Integr Med 2017;23:306–311.

    Article  CAS  Google Scholar 

  20. Wu JR, Zhang XM, Zhang B, Zhai MD, Sheng XG. Systematic evaluation on Danshen Chuanxiongqin Injection in the treatment of angina pectoris. Chin J Inf Tradit Chin Med (Chin) 2015;22:39–43.

    Google Scholar 

  21. Wang Y, Guo G, Yang BR, Xin QQ, Liao QW, Lee SM, et al. Synergistic effects of Chuanxiong-Chishao herb-pair on promoting angiogenesis at network pharmacological and pharmacodynamic levels. Chin J Integr Med 2017;32:654–662.

    Article  Google Scholar 

  22. Jia Y, Leung SW, Lee MY, Cui G, Huang X, Pan F. The efficacy of Guanxinning Injection in treating angina pectoris: systematic review and meta-analysis of randomized controlled trials. Evid Based Complement Alternat Med 2013;2013:282707.

    PubMed  PubMed Central  Google Scholar 

  23. Cheng XL, Yan XT, Tu ZL, Xiao MS, Wang XT, Luo DQ. Protective effect of Guanxinning Injection on myocardial ischemia reperfusion injury in rats and effect on heat shock protein 70 expression. Chin J Hosp Pharm (Chin) 2009;29:1080–1082.

    Google Scholar 

  24. Chen ML, Shou QY, Pan YM, Zhang JB, Sang R, Guan MW, et al. Inhibitive and protective effects of Guanxinning Tablets on platelet aggregation and vascular endothelium in qi stagnation and blood stasis rats. Chin J Clin Pharm Therap (Chin) 2005;10:586–589.

    Google Scholar 

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Acknowledgement

The authors would like to thank the staff at the Xiyuan Hospital of China Academy of Chinese Medical Sciences, Jilin Integrated Chinese and Western Hospital, Affiliated Hospital of Changchun University of Chinese Medicine, Hubei Provincial Hospital of Traditional Chinese Medicine, Affiliated Hospital of Inner Mongolia University for the Nationalities and Shanghai Municipal Hospital of Traditional Chinese Medicine Affiliated to Shanghai University of Traditional Chinese Medicine, for their invaluable help in conducting this study.

Author information

Authors and Affiliations

  1. Good Clinical Practice Center, Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing, 100091, China

    Ming-yue Sun & Rui Gao

  2. Department of Cardiology, Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing, 100091, China

    Yang Miao

  3. Chiatai Qingchunbao Pharmaceutical Co., Ltd., Hangzhou, 310023, China

    Min Jin & Mu-lan Wang

  4. Department of Cardiology, Shanghai Municipal Hospital of Traditional Chinese Medicine Affiliated to Shanghai University of Traditional Chinese Medicine, Shanghai, 200071, China

    Yao-rong Dong

  5. Department of Cardiology, The First Clinical Hospital of Jilin Academy of Chinese Medical Sciences, Changchun, 130021, China

    Shu-rong Liu

Authors
  1. Ming-yue Sun
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  2. Yang Miao
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  3. Min Jin
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  4. Yao-rong Dong
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  5. Shu-rong Liu
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  6. Mu-lan Wang
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  7. Rui Gao
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Contributions

Gao R and Miao Y were involved in the conception or design of the study; Miao Y, Dong YR, and Liu SR were involved in clinical observation; Wang ML and Jin M collected the data; Sun MY, Gao R, and Jin M analyzed the data and drafted the article.

Corresponding author

Correspondence to Rui Gao.

Ethics declarations

This research received a research grant from Chiatai Qingchunbao Pharmaceutical Co., Ltd., China.

Additional information

Supported by the National Major Scientific and Technological Special Project for Significant New Drugs Development (No. 2012ZX09303-010-002), China

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Sun, My., Miao, Y., Jin, M. et al. Effect and Safety of Guanxinning Tablet (冠心宁片) for Stable Angina Pectoris Patients with Xin (Heart)-Blood Stagnation Syndrome: A Randomized, Multicenter, Placebo-Controlled Trial. Chin. J. Integr. Med. 25, 684–690 (2019). https://doi.org/10.1007/s11655-019-3069-8

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  • DOI: https://doi.org/10.1007/s11655-019-3069-8

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