Effectiveness of Shenshu Guanxin recipe granules (参术冠心方颗粒) for improving exercise tolerance in patients with stable angina pectoris: a randomized, double-blind, placebo-controlled trial

doi:10.19852/j.cnki.jtcm.20231008.001

Abstract

Abstract:

OBJECTIVE: To assess the effectivess of Shenshu Guanxin recipe granules (参术冠心方颗粒, SGR) in improving exercise tolerance and the quality of life in patients with Stable Angina Pectoris (SAP).
METHODS: A total of 189 patients were consecutively enrolled between December 2012 and December 2014. The included patients were randomly assigned to SGR and placebo groups. The primary endpoints included mainly the results of treadmill exercise test and Seattle Angina Questionnaire (SAQ) during 12 weeks of treatment.
RESULTS: After 12 weeks of treatment, SGR extended the time of exercise-induced ST-segment depression of 0.1 MV, lowered the maximum ST-segment depression, and shortened the duration of ST-segment depression in patients with SAP in southern China. Besides, the study also proved that SGR could improve the quality of life and functional status of patients with SAP.
CONCLUSIONS: SGR showed a positive effect on exercise tolerance compared with the placebo besides optimal medical therapy. Also, the study proved that SGR could improve the SAQ score of the patients.

Key words: exercise tolerance, angina, stable, Seattle Angina Questionnaire, Shenshu Guanxin recipe granules

JIN Xiao, WU Bingxin, WU Huanlin, XU Danping. Effectiveness of Shenshu Guanxin recipe granules (参术冠心方颗粒) for improving exercise tolerance in patients with stable angina pectoris: a randomized, double-blind, placebo-controlled trial[J]. Journal of Traditional Chinese Medicine, 2023, 43(6): 1227-1233.

Figures/Tables 4

References 29.

1.	Collaborators GCoD. Global, regional, and national age-sex specific mortality for 264 causes of death, 1980-2016: a systematic analysis for the Global Burden of Disease Study 2016. Lancet 2017;390: 1151-210.
2.	Zhu KF, Wang YM, Zhu JZ, Zhou QY, Wang NF. National prevalence of coronary heart disease and its relationship with human development index: a systematic review. Eur J Prev Cardiol 2016; 23: 530-43. DOI URL
3.	Chen M, Li M, Ou L, et al. Effectiveness and safety of Chinese herbal medicine formula Gualou Xiebai Banxia (GLXBBX) decoction for the treatment of stable angina pectoris: Protocol for a systematic review. Medicine (Baltimore) 2018; 97: e11680. DOI URL
4.	Manolis AJ, Ambrosio G, Collins P, et al. Impact of stable angina on health status and quality of life perception of currently treated patients. The BRIDGE 2 survey. Eur J Intern Med 2019; 70: 60-7.
5.	Levine GN, Bates ER, Bittl JA, et al. 2016 ACC/AHA guideline focused update on duration of dual antiplatelet therapy in patients with coronary artery disease: a report of the American college of Cardiology/American heart association task force on clinical practice guidelines:an update of the 2011 ACCF/AHA/SCAI guideline for percutaneous coronary intervention, 2011 ACCF/AHA guideline for coronary artery bypass graft surgery, 2012 ACC/AHA/ACP/AATS/PCNA/SCAI/STS guideline for the diagnosis and management of patients wth stable ischemic heart disease, 2013 ACCF/AHA guideline for the management of ST-elevation myocardial infarction, 2014 AHA/ACC guideline for the management of patients with non-ST-elevation acute coronary syndromes, and 2014 ACC/AHA guideline on perioperative cardiovascular evaluation and management of patients undergoing noncardiac surgery. Circulation 2016; 134: e123-55.
6.	Montalescot G, Sechtem U, Achenbach S, 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. DOI PMID
7.	Timmis A, Roobottom CA. National institute for health and care excellence updates the stable chest pain guideline with radical changes to the diagnostic paradigm. Heart 2017; 103: 982-86. DOI PMID
8.	Lam TH, Liu LJ, Janus ED, Lau CP, Hedley AJ. Fibrinogen, angina and coronary heart disease in a Chinese population. Atherosclerosis 2000; 149: 443-9. DOI PMID
9.	Luo J, Shang Q, Han M, Chen K, Xu H. Traditional Chinese Medicine injection for angina pectoris: an overview of systematic reviews. Am J Chin Med 2014; 4: 37-59.
10.	Tang Y, Cai H, Zhan Z, et al. Herbal medicine (Zhishi Xiebai Guizhi decoction) for unstable angina: Protocol for a systematic review and Meta-analysis. Medicine (Baltimore) 2018; 97: e13965. DOI URL
11.	Zhang Z, Zhang F, Wang Y, et al. Traditional Chinese Medicine for stable angina pectoris via TCM pattern differentiation and TCM mechanism: study protocol of a randomized controlled trial. Trials 2014; 15: 422-28. DOI PMID
12.	Jo J, Leem J, Lee JM, Park KS. Herbal medicine (Hyeolbuchukeo-Tang or Xuefu Zhuyu decoction) for treating primary dysmenorrhoea: protocol for a systematic review of randomised controlled trials. BMJ Open 2017; 7: e015056. DOI URL
13.	Wang PQ, Li DD, Dong W, et al. Danhong injection in the treatment of chronic stable angina: study protocol for a randomized controlled trial. Trials 2015; 16: 474-9. DOI PMID
14.	Huang J, Tang X, Ye F, He J, Kong X. Clinical therapeutic effects of aspirin in combination with Fufang Danshen Diwan, a Traditional Chinese Medicine formula, on coronary heart disease: a systematic review and Meta-analysis. Cell Physiol Biochem 2016; 39: 1955-63. PMID
15.	Zhang Y, Xie Y, Liao X, Jia Q, Chai Y. A Chinese patent medicine salvia miltiorrhiza depside salts for infusion combined with conventional treatment for patients with angina pectoris: a systematic review and Meta-analysis of randomized controlled trials. Phytomedicine 2017; 25: 100-17. DOI PMID
16.	Mao S, Xu DP, Dang XJ, Li W, Wu HL. Shenzhu Guanxin recipe granules for improving exercise tolerance in patients with stable angina (SERIES Trial): a protocol of multicenter, randomized, double-blind, placebo parallel controlled clinical trial. Chin J Integr Med 2019; 25: 96-102. DOI
17.	Xu DP, Wu HL, Lan TH, et al. Effect of Shenzhu Guanxin recipe on patients with angina pectoris after percutaneous coronary intervention: a prospective, randomized controlled trial. Chin J Integr Med 2015; 21: 408-16. DOI URL
18.	Xu DP, Zou DZ, Qiu HL, Wu HL. Traditional Chinese Medicine Shenzhu Guanxin granules mitigate cardiac dysfunction and promote myocardium angiogenesis in myocardial infarction rats by upregulating PECAM-1/CD31 and VEGF Expression. Evid Based Complement Alternat Med 2017;2017: 5261729.
19.	Moher D, Hopewell S, Schulz KF, et al. CONSORT 2010 explanation and elaboration: updated guidelines for reporting parallel group randomised trials. Int J Surg 2012; 10: 28-55.
20.	Shkolnik E, Burneikaite G, Celutkiene J, et al. Efficacy of cardiac shock wave therapy in patients with stable angina: the design of randomized, triple blind, sham-procedure controlled study. Anatol J Cardiol 2018; 19: 100-9. DOI PMID
21.	Shkolnik E, Burneikaite G, Jakutis G, et al. A randomized, triple-blind trial of cardiac shock-wave therapy on exercise tolerance and symptoms in patients with stable angina pectoris. Coron Artery Dis 2018; 29: 579-86. DOI PMID
22.	Kaul P, Naylor CD, Armstrong PW, Mark DB, Theroux P, Dagenais GR. Assessment of activity status and survival according to the Canadian Cardiovascular Society angina classification. Can J Cardiol 2009; 25: e225-31.
23.	Virani SS, Newby LK, Arnold SV, et al. 2023 AHA/ACC/ACCP/ASPC/NLA/PCNA guideline for the management of patients with chronic coronary disease: a report of the American Heart Association/American college of cardiology joint committee on clinical practice guidelines. Circulation 2023; 148: e9-119.
24.	Zhao S, Tang Y, Cai H, et al. Treatment of Danhong injection combined with Naoxintong capsule in acute coronary syndrome patients undergoing PCI operation: study for a randomized controlled and double-blind trial. Evid Based Complement Alternat Med 2018; 2018: 8485472.
25.	Salazar CA, Basilio Flores JE, Veramendi Espinoza LE, Mejia Dolores JW, Rey Rodriguez DE, Loza Munárriz C. Ranolazine for stable angina pectoris. Cochrane Database Syst Rev 2017; 2: Cd011747.
26.	Liao W, Ma X, Li J, et al. A review of the mechanism of action of Dantonic(®) for the treatment of chronic stable angina. Biomed Pharmacother 2019; 109: 690-700. DOI URL
27.	Ren Y, Zhang M, Chen K, et al. Clinical and epidemiological investigation of TCM syndromes of patients with coronary heart disease in China. Evid Based Complement Alternat Med 2012; 2012: 714517.
28.	Huang M, Wu H, Wu J, Chen Q, Zou D, Xu D. Prevention of platelet aggregation and arterial thrombosis using a modified Shenzhu Guanxin formula. J Int Med Res 2020; 48: 300-26.
29.	Scott RC, Rosano JM, Ivanov Z, et al. Targeting VEGF-encapsulated immunoliposomes to MI heart improves vascularity and cardiac function. Faseb j 2009; 23: 3361-7. DOI PMID

Characteristic		SGR+OMT (n = 94)	Placebo+OMT (n = 95)	All ( n = 189)	P value
Age (years)		57±8	57±9	57±9	>0.05
Female [n (%)]		34 (37)	42 (45)	76 (40.2)	>0.05
Course of disease (months)		20±28	17±25	26±19	>0.05
Family history of cardiovascular diseases (%)		16.0	11.8	13.7	>0.05
Smoking history (%)		41.3	37.6	38.6	>0.05
Measurements	Systolic BP (mm Hg)	127.69±14.13	125.35±16.45	126.52±15.29	>0.05
	Diastolic BP (mm Hg)	73.56±9.83	71.82±9.37	72.69±9.60	>0.05
	Heart rate (beats/min)	72.32±9.08	68.83±12.65	70.57±10.86	>0.05
Medical history [n (%)]	Hypertension	35 (38.0)	38 (40.1)	73 (38.6)	>0.05
	Diabetes	24 (26.1)	23 (24.7)	47 (24.8)	>0.05
	Dyslipidemia	45 (48.9)	43 (47.7)	88 (46.5)	>0.05
	Gastrointestinal diseases	21 (22.8)	22 (23.6)	43 (22.7)	>0.05
Medication [n (%)]	β-Blockers	43 (46.7)	40 (43.0)	83 (43.9)	>0.05
	Serum lipid adjustment drugs	57 (61.9)	53 (56.9)	110 (58.2)	>0.05
	Calcium channel blockers	30 (32.6)	33 (35.4)	63 (33.3)	>0.05
	Antiplatelet drugs	88 (95.6)	87 (93.5)	175 (92.6)	>0.05
	long-acting nitrate	21 (11.1)	24 (12.7)	45 (23.8)	0.62
Angina pectoris class (%)	Ⅰ	0	0	0	/
	Ⅱ	84 (91.3)	80 (86.02)	164 (84.6)	>0.05
	Ⅲ	8 (8.7)	13 (13.9)	21 (11.1)	>0.05
Number of culprit coronary arteries [n (%)]	3-vessel disease	14 (14.9)	15 (15.8)	29 (15.3)	0.864
	2-vessel disease	38 (40.4)	39 (41.0)	77 (81.1)	0.930
	1-vessel disease	42 (44.7)	41 (43.1)	83 (43.9)	0.833
degree of coronary artery stenosis [n (%)]	50%-60%	36 (38.3)	38 (40.0)	74 (39.2)	0.811
	60%-70%	41 (43.6)	42 (44.2)	83 (43.9)	0.934
	70%-80%	16 (17.0)	13 (13.7)	29 (15.3)	0.524
	80%-90%	1 (1.1)	2 (2.1)	3 (1.6)	0.567

Characteristic		SGR+OMT (n = 94)	Placebo+OMT (n = 95)	All ( n = 189)	P value
Age (years)		57±8	57±9	57±9	>0.05
Female [n (%)]		34 (37)	42 (45)	76 (40.2)	>0.05
Course of disease (months)		20±28	17±25	26±19	>0.05
Family history of cardiovascular diseases (%)		16.0	11.8	13.7	>0.05
Smoking history (%)		41.3	37.6	38.6	>0.05
Measurements	Systolic BP (mm Hg)	127.69±14.13	125.35±16.45	126.52±15.29	>0.05
	Diastolic BP (mm Hg)	73.56±9.83	71.82±9.37	72.69±9.60	>0.05
	Heart rate (beats/min)	72.32±9.08	68.83±12.65	70.57±10.86	>0.05
Medical history [n (%)]	Hypertension	35 (38.0)	38 (40.1)	73 (38.6)	>0.05
	Diabetes	24 (26.1)	23 (24.7)	47 (24.8)	>0.05
	Dyslipidemia	45 (48.9)	43 (47.7)	88 (46.5)	>0.05
	Gastrointestinal diseases	21 (22.8)	22 (23.6)	43 (22.7)	>0.05
Medication [n (%)]	β-Blockers	43 (46.7)	40 (43.0)	83 (43.9)	>0.05
	Serum lipid adjustment drugs	57 (61.9)	53 (56.9)	110 (58.2)	>0.05
	Calcium channel blockers	30 (32.6)	33 (35.4)	63 (33.3)	>0.05
	Antiplatelet drugs	88 (95.6)	87 (93.5)	175 (92.6)	>0.05
	long-acting nitrate	21 (11.1)	24 (12.7)	45 (23.8)	0.62
Angina pectoris class (%)	Ⅰ	0	0	0	/
	Ⅱ	84 (91.3)	80 (86.02)	164 (84.6)	>0.05
	Ⅲ	8 (8.7)	13 (13.9)	21 (11.1)	>0.05
Number of culprit coronary arteries [n (%)]	3-vessel disease	14 (14.9)	15 (15.8)	29 (15.3)	0.864
	2-vessel disease	38 (40.4)	39 (41.0)	77 (81.1)	0.930
	1-vessel disease	42 (44.7)	41 (43.1)	83 (43.9)	0.833
degree of coronary artery stenosis [n (%)]	50%-60%	36 (38.3)	38 (40.0)	74 (39.2)	0.811
	60%-70%	41 (43.6)	42 (44.2)	83 (43.9)	0.934
	70%-80%	16 (17.0)	13 (13.7)	29 (15.3)	0.524
	80%-90%	1 (1.1)	2 (2.1)	3 (1.6)	0.567

Item	SGR+OMT group (n = 88)			Placebo+OMT group (n = 87)
Item	Baseline	12 weeks	P value		Baseline	12 weeks	P value	P value
Total exercise time	655.9±244.9	674.3±255.5	0.313	648.8±225.0		682.9±178.0	0.134	0.398
Maximum load (METs)	11.3±2.3	11.6±2.2	0.15	11.4±2.9		11.8±2.7	0.173	0.689
Time of exercise-induced ST-segment depression of 0.1 MV	366.7±177.5	420.0±174.7	0.023^a	371.6±170.5		383.6±156.3	0.315	0.286
Maximum ST-segment depression	1.6±0.9	1.2±1.2	0.006^a	1.9±1.2		1.2±1.0	0.001^a	0.520
Duration of ST-segment depression	159.6±138.4	122.5±139.9	0.039^a	173.5±146.2		146.3±129.3	0.09	0.009^b

Item	SGR+OMT group (n = 88)			Placebo+OMT group (n = 87)
Item	Baseline	12 weeks	P value		Baseline	12 weeks	P value	P value
Total exercise time	655.9±244.9	674.3±255.5	0.313	648.8±225.0		682.9±178.0	0.134	0.398
Maximum load (METs)	11.3±2.3	11.6±2.2	0.15	11.4±2.9		11.8±2.7	0.173	0.689
Time of exercise-induced ST-segment depression of 0.1 MV	366.7±177.5	420.0±174.7	0.023^a	371.6±170.5		383.6±156.3	0.315	0.286
Maximum ST-segment depression	1.6±0.9	1.2±1.2	0.006^a	1.9±1.2		1.2±1.0	0.001^a	0.520
Duration of ST-segment depression	159.6±138.4	122.5±139.9	0.039^a	173.5±146.2		146.3±129.3	0.09	0.009^b

Item	SGR+OMT (n = 88)
Item	Baseline	12 weeks	P value		Baseline	12 weeks	P value	P value
Physical limitation	55±6	62±4	< 0.001^a	56±5		61±4	< 0.001^a	< 0.001^b
Angina stability	41±11	85±14	< 0.001^a	42±12		73±13	< 0.001^a	< 0.001^b
Angina frequency	43±8	78±10	< 0.001^a	45±11		76±12	< 0.001^a	0.880
Treatment satisfaction	36±10	85±6	< 0.001^a	38±12		85±12	< 0.001^a	0.408
Disease perception	38±10	61±10	< 0.001^a	39±11		61±11	< 0.001^a	0.632

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