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Open Access 01-12-2021 | Coronary Heart Disease | Study protocol

Efficacy and safety of Chinese herbal medicine Wen Xin granules for the treatment of unstable angina pectoris with Yang deficiency and blood stasis syndrome: study protocol for a randomized controlled trial

Authors: Pan-pan Tian, Qing-juan Wu, Jun Li, Heng-wen Chen, Ji Wu, Ya-wen Deng, Zi-cong Xie, Wei Zhao, Yu-qing Tan

Published in: Trials | Issue 1/2021

Abstract

Introduction

Unstable angina pectoris (UAP) is the common type of coronary heart disease with the risk of developing into acute myocardial infarction (AMI). Currently, there are still numerous patients suffering from recurrent angina after revascularization or conventional medication due to the microvascular lesions, endothelial dysfunction, chronic inflammation, in-stent restenosis, and other factors. As an important part of China’s medical and health care system, traditional Chinese medicine (TCM) has rich clinical experience in the treatment of UAP. According to the theory of TCM, Yang deficiency and blood stasis syndrome is a common type of UAP. Wen Xin decoction, as a type of Chinese herbal medicine, has been used in the clinic for years and shown great efficacy in the treatment of UAP with Yang deficiency and blood stasis syndrome. This study aims to evaluate the efficacy and safety of Wen Xin granular in patients with UAP.

Methods and analysis

This is a double-blinded, randomized, placebo-controlled clinical trial. A total of 502 participants will be randomly allocated to the intervention group and the placebo group. Based on conventional medication, the intervention group will be treated with Wen Xin granular and the placebo group will be treated with Wen Xin granular placebo. The primary outcomes are major adverse cardiovascular events (MACE). Assessments will be performed 1 year after the treatment. The secondary outcomes include TCM symptom scale score, Seattle angina questionnaire, and thromboelastography. Assessments will be performed at baseline (before randomization) and 4 and 8 weeks after randomization.

Discussion

This trial will provide high-quality data on the benefits and risks of Wen Xin granular in patients with UAP.

Trial registration

ClinicalTrials.govNCT04661709. Registered on 30 November 2020

Global Health Estimates 2016: Deaths by cause, age, sex, by country and by region. Geneva. World Health Organization. 2000-2016;2018.

Mair J, Puschendorf B, Michel G. Clinical significance of cardiac contractile proteins for the diagnosis of myocardial injury. Advances in Clinical Chemistry. 1994;31:63. https://doi.org/10.1016/S0065-2423(08)60333-9.CrossRefPubMed

Reynolds P. Clinical development and progression of coronary heart disease. A Comprehensive Guide to Geriatric Rehabilitation (Third Edition), 2014:275-280.doi: https://doi.org/10.1016/B978-0-7020-4588-2.00040-1

Aznaouridis K, Masoura K, Tousoulis D. Regulation of oxygen transport and coronary blood flow. Coronary Artery Disease. 2018:137–56. https://doi.org/10.1016/B978-0-12-811908-2.00010-6.

Kloner RA, Chaitman B. Angina and its management. J Cardiovasc Pharmacol Ther. 2017;22(3):199–209. https://doi.org/10.1177/1074248416679733 Epub 2016 Dec 14. PMID: 28196437.CrossRefPubMed

Smith JN, Negrelli JM, Manek MB, Hawes EM, Viera AJ. Diagnosis and management of acute coronary syndrome: an evidence-based update. J Am Board Fam Med. 2015;28(2):283–93. 25748771. https://doi.org/10.3122/jabfm.2015.02.140189.CrossRefPubMed

Ambrose JA, Dangas G. Unstable angina: current concepts of pathogenesis and treatment. Arch Intern Med. 2000;160(1):25–37. 10632302. https://doi.org/10.1001/archinte.160.1.25.CrossRefPubMed

Park KE, Conti CR. Non-PCI/CABG therapies for refractory angina. Trends Cardiovasc Med. 2018;28(3):223–8. https://doi.org/10.1016/j.tcm.2017.10.002 Epub 2017 Oct 20. PMID: 29157949.CrossRefPubMed

Niccoli G, Montone RA, Lanza GA, Crea F. Angina after percutaneous coronary intervention: the need for precision medicine. International Journal of Cardiology. 2017;S0167527317333600:14–9. https://doi.org/10.1016/j.ijcard.2017.07.105.CrossRef

10.

Jiang YR, Wang PL, Fu CG, et al. Guidelines for diagnosis and treatment of angina pectoris after coronary artery revascularization with integrative medicine. Chinese Journal of Integrated Traditional and Western Medicine. 2020;40(11):1298–307.

11.

Jiang M, Zhang C, Zheng G, Guo H, Li L, Yang J, et al. Traditional Chinese medicine Zheng in the era of evidence-based medicine: a literature analysis. Evid Based Complement Alternat Med. 2012;2012:409568–9. https://doi.org/10.1155/2012/409568.CrossRefPubMedPubMedCentral

12.

Zhang HJ, Wang ZX. Yin-yang and Zheng: exported from Chinese medicine. Chin J Integr Med. 2014;20(4):250–5. https://doi.org/10.1007/s11655-014-1777-z Epub 2014 Apr 3. PMID: 26972437.CrossRefPubMed

13.

Song XH, Li J, Li CS. Effect of Wenxin decoction on high-sensitivity C reactive protein and D-two polymer in patients with unstable angina pectoris. Chin J Integr Med Cardio-Cerebrovasc Dis. 2008;6:635–7.

14.

LI J, Cheng GQ, LI CS. Effects of Wenxin decoction on plasma Fib, IL-6, IL-8 ofpatients with unstable angina pectoris. Shandong J Tradit Chin Med. 2005;11:650–2. https://doi.org/10.3969/j.issn.0257-358X.2005.11.003.CrossRef

15.

LI J, LI CS, Cheng GQ, et al. Clinical study on unstable angina pectoris treated by Wenxintang. Chin J Inform Tradit Chin Med. 2006;3:17–9. https://doi.org/10.3969/j.issn.1005-5304.2006.03.006.CrossRef

16.

Li J, Zhang ZP, XIONG XJ, et al. Randomized controlled trial of Wenxin decoction for unstable angina. Chin J Exp Tradit Med Formulae. 2016;4:154–8.

17.

Amsterdam EA, Wenger NK, Brindis RG, et al. 2014 AHA/ACC guideline for the management of patients with non-ST-elevation acute coronary syndromes: executive summary: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. Circulation. 2014;25:e431–2.

18.

Zheng XY. Guideline of clinical research of new drugs of traditional Chinese medicine: chest obstruction. Chin Med Sci & Tech Press. 2002:68–73.

19.

Jensen MT, Sogaard P, Gustafsson I, Bech J, Hansen TF, Almdal T, et al. Echocardiography improves prediction of major adverse cardiovascular events in a population with type 1 diabetes and without known heart disease: the Thousand & 1 Study. Diabetologia. 2019;62(12):2354–64. https://doi.org/10.1007/s00125-019-05009-2.CrossRefPubMed

20.

Liu JP. Calculation of sample size in clinical trials. Chinese Journal of Integrated Traditional and Western Medicine. 2003;07:536–8.

21.

Luo WY, Zheng X. Application of medical statistics in clinical scientific research. Medical Innovation of China. 2013;10(16):146–7.

22.

Xie Q, Cheng XM, Hu FD, et al. Research advance on chemical constituents, pharmacological action and quality control of Radix Codonopsis. Shanghai Journal of Traditional Chinese Medicine. 2020;54(08):94–104.

23.

Wan HX, Wang YL, Zhou CZ, et al. Research progress on chemical constituents and pharmacological effects of Salvia miltiorrhiza. Chinese Traditional and Herbal Drugs. 2020;51(03):788–98.

24.

Zhang XJ, Zhang YL, Zuo DD. Research progress on chemical constituents and pharmacological effects of Ligusticum chuanxiong Hort. Information on Traditional Chinese Medicine. 2020;37(06):128–33.

25.

Huang Y, Wang Q, Zhu XW, et al. Pharmacological effect and research progress of Trichosanthes kirilowii in the treatment of coronary heart disease. Cardiovascular Disease Electronic Journal of Integrated Traditional Chinese and Western Medicine. 2019;7(23):18.

26.

Chan AW, Tetzlaff JM, Altman DG, Laupacis A, Gøtzsche PC, Krleža-Jerić K, et al. SPIRIT 2013 statement: defining standard protocol items for clinical trials. Ann Intern Med. 2013;158(3):200–7. https://doi.org/10.7326/0003-4819-158-3-201302050-00583.CrossRefPubMedPubMedCentral

Title: Efficacy and safety of Chinese herbal medicine Wen Xin granules for the treatment of unstable angina pectoris with Yang deficiency and blood stasis syndrome: study protocol for a randomized controlled trial
Authors: Pan-pan Tian
Qing-juan Wu
Jun Li
Heng-wen Chen
Ji Wu
Ya-wen Deng
Zi-cong Xie
Wei Zhao
Yu-qing Tan
Publication date: 01-12-2021
Publisher: BioMed Central
Keywords: Coronary Heart Disease
Unstable Angina
Published in: Trials / Issue 1/2021
Electronic ISSN: 1745-6215
DOI: https://doi.org/10.1186/s13063-021-05771-y

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Efficacy and safety of Chinese herbal medicine Wen Xin granules for the treatment of unstable angina pectoris with Yang deficiency and blood stasis syndrome: study protocol for a randomized controlled trial

Abstract

Introduction

Methods and analysis

Discussion

Trial registration

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Abstract

Introduction

Methods and analysis

Discussion

Trial registration

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