Efficacy and safety of Yi’anning pills (益安宁丸) for stable angina pectoris in coronary heart disease with Qi-blood and liver-kidney deficiency syndrome: a multicenter, randomized, double-blind, superiority clinical trial

doi:10.19852/j.cnki.jtcm.2026.02.012

Abstract

Abstract:

OBJECTIVE: To evaluate the efficacy and safety of Yi’anning pills (益安宁丸) for the treatment of stable angina pectoris in coronary heart disease with Qi-blood deficiency syndrome and liver-kidney deficiency syndrome.

METHODS: This study was a multicenter, randomized, double-blind, double-dummy, positive-controlled clinical trial. Participants were randomly divided into the experimental group and the control group (3∶1) using the randomized block method. All participants received guideline-standardized treatment for stable angina pectoris associated with coronary heart disease, among whom the first 64 participants underwent the treadmill exercise test. The experimental group was also treated with Yi’anning pills and Xinyuan capsules (心元胶囊) simulant, while the control group received Yi’anning pills simulant and Xinyuan capsules, both for 8 weeks. The primary clinical outcome was the total Seattle Angina Questionnaire (SAQ) score, and the secondary clinical outcomes were the individual SAQ scores, treadmill exercise test results, rate of nitroglycerin cessation or reduction, classification of angina pectoris severity, and therapeutic effect against Traditional Chinese Medicine syndrome.

RESULTS: Overall, 158 participants were included from nine sub-centers, including 119 in the experimental group and 39 in the control group. After 8 weeks of treatment, the experimental intervention was superior to the control intervention in terms of the increase in total SAQ score (P <0.05). For the individual SAQ scores, the experimental intervention had an advantage over the control intervention in the reduction in physical activity limitation (P <0.05), the improvement in angina pectoris stability (P <0.05), and the frequency of angina pectoris attacks (P <0.05). Regarding the treadmill exercise test, the experimental intervention was superior to the control intervention for augmenting the maximum exercise heart rate (P > 0.05) and improving the angina-free rate after treatment (P > 0.05), but the differences were not statistically significant. The rate of nitroglycerin cessation or reduction was higher in the experimental group than in the control group (P <0.05). Regarding angina pectoris severity classification, the efficacy rate in the experimental group was higher than in the control group (P <0.05). Regarding the therapeutic effect against Traditional Chinese Medicine syndromes, the efficacy rates against Qi-blood deficiency syndrome and liver-kidney deficiency syndrome in the experimental group were both greater than those in the control group (both P <0.05). There was no statistically significant difference in adverse events between the two groups (P > 0.05).

CONCLUSION: Based on the standardized treatment of stable angina pectoris in coronary heart disease, Yi’anning pills outperformed Xinyuan capsules in terms of the total SAQ score, demonstrating a good clinical effect and safe application.

Key words: liver-kidney deficiency syndrome, Qi-blood deficiency syndrome, randomized controlled trial, stable angina pectoris of coronary heart disease, Yi’anning pills

LI Shuning, LIU Hongxu, LAI Xiaolei, SHANG Juju, XING Wenlong, ZHANG Heyi. Efficacy and safety of Yi’anning pills (益安宁丸) for stable angina pectoris in coronary heart disease with Qi-blood and liver-kidney deficiency syndrome: a multicenter, randomized, double-blind, superiority clinical trial[J]. Journal of Traditional Chinese Medicine, 2026, 46(2): 401-410.

Figures/Tables 4

References 24.

1.	Wang J, Chen G. Expert consensus on diagnosis and treatment of stable angina pectoris in coronary heart disease with Traditional Chinese Medicine. Zhong Yi Za Zhi 2018; 59: 447-50.
2.	Chinese Medical Association, Chinese Medical Association Press, General Practice Branch of Chinese Medical Association, etc. Guidelines for primary care diagnosis and treatment of stable coronary heart disease (2020). Zhong Hua Quan Ke Yi Shi Za Zhi 2021; 20: 265-73.
3.	Summary of Chinese cardiovascular health and disease report 2024. Zhong Guo Xun Huan Za Zhi 2025; 40: 521-59.
4.	de Koning IA, Heutinck JM, Vromen T, et al. Cardiac rehabilitation vs percutaneous coronary intervention for stable angina pectoris: a retrospective study of effects on major adverse cardiovascular events and associated healthcare costs. Eur J Prev Cardiol 2024; 31: 1987-90. DOI PMID
5.	Xiao J, Wu BX, Lin MY, Zhong BY, Lin LQ, Xu DP. Clinical efficacy and gene chip expression analysis of Shenzhu Guanxin recipe granules in patients with intermediate coronary lesions. J Tradit Chin Med 2024; 44: 545-53. DOI
6.	Wang ZB, Li Y, Wang DP, et al. Proteomics analysis of coronary atherosclerotic heart disease with different Traditional Chinese Medicine syndrome types before and after percutaneous coronary intervention. J Tradit Chin Med 2024; 44: 554-63. DOI
7.	Wu HL, Li XM, Luo WJ, et al. Randomized controlled clinical study of Deng's Guanxin capsules in the treatment of stable angina pectoris of coronary heart disease. Zhong Yi Za Zhi 2006; 1: 24-7.
8.	Bi YF, Mao JY, Wang XL, et al. Thoughts on the clinical advantages of Traditional Chinese Medicine in the prevention and treatment of coronary heart disease and related efficacy evaluation. Zhong Yi Za Zhi 2015; 56: 437-40.
9.	Liu J, Li DD, Dong W, et al. Detection of an anti-angina therapeutic module in the effective population treated by a multi-target drug Danhong injection: a randomized trial. Signal Transduct Target Ther 2021; 6: 329.
10.	Zhang QH, Li HX. Clinical observation of 60 cases of angina pectoris in coronary heart disease treated with Yi’anning. Yi Nan Bing Za Zhi 2006; 6: 411-4.
11.	Jin X, Wu BX, Wu HL, Xu DP. Effectiveness of Shenshu Guanxin recipe granules for improving exercise tolerance in patients with stable angina pectoris: a randomized, double-blind, placebo-controlled trial. J Tradit Chin Med 2023; 43: 1227-33.
12.	Interventional Cardiology Group, Cardiovascular Branch of Chinese Medical Association; Atherosclerosis and Coronary Heart Disease Group, Cardiovascular Branch of Chinese Medical Association; Thrombosis Prevention and Treatment Professional Committee, Cardiovascular Internal Medicine Physicians Branch of Chinese Medical Doctor Association, etc. Guidelines for the diagnosis and treatment of stable coronary heart disease. Zhong Hua Xin Xue Guan Bing Za Zhi 2018; 46: 680-94.
13.	National Medical Products Administration.Technical guidelines for clinical research of new symptomatic Traditional Chinese Medicines. 2018-11-01, cited 2025-07-20; 1 screen. Available from URL: https://www.nmpa.gov.cn/xxgk/ggtg/ypggtg/ypqtggtg/20181106155701473.html.
14.	Campeau L. Letter: Grading of angina pectoris. Circulation 1976; 54: 522-3. PMID
15.	National Medical Products Administration.Guiding principles for the protection of Traditional Chinese Medicine varieties (2009). 2009-02-03, cited 2025-07-20; 4 screens. Available from URL: https://www.nmpa.gov.cn/xxgk/fgwj/gzwj/gzwjyp/20090203120001961_3.html.
16.	Zhang YP. Jin Gui Yao Lue. Fuzhou: Fujian Science and Technology Publishing House, 2011: 35.
17.	Zhang JY (Ming dynasty). Jing Yue Quan Shu. Beijing: People's Medical Publishing House, 1991: 1242.
18.	Chen Y, Xiao X, Xu X, Zhang Z, Deng Y. Traditional Chinese Medicine in the prevention and treatment of stable angina pectoris in patients with coronary heart disease based on the theory of "phlegm and blood stasis" under guidance of evidence-based medicine: a prospective cohort study. J Tradit Chin Med 2021; 41: 150-6.
19.	Luan F, Zou J, Zhang X, et al. The extraction, purification, structural features, bioactivities, and applications of Schisandra chinensis polysaccharides: a review. Int J Biol Macromol 2024; 262: 130030. DOI URL
20.	Wu Y, Ding C, Liu C, et al. Schisandrol A, the major active constitute in schisandra chinensis: a review of its preparation, biological activities, and pharmacokinetics analysis. Am J Chin Med 2024; 52: 717-52. DOI URL
21.	Wang D, Zhang X, Bian Z, et al. Multiple fingerprinting and cardioprotective activity of salvia miltiorrhiza polysaccharides. Int J Biol Macromol 2025; 306: 141468. DOI URL
22.	Yan J, Cai QQ, Li Y, Zhang HM, Zhang FB. Network pharmacology and molecular docking explore mechanism of Croci Stigma in treating immune checkpoint inhibitor-associated myocarditis. Zhong Guo Zhong Yao Za Zhi 2025; 50: 2515-25.
23.	Xia W, Sun C, Zhao Y, Wu L. Hypolipidemic and antioxidant activities of Sanchi (Radix Notoginseng) in rats fed with a high fat diet. Phytomedicine 2011; 18: 516-20. DOI PMID
24.	Lei W, Yan Y, Ma Y, et al. Notoginsenoside R1 regulates ischemic myocardial lipid metabolism by activating the AKT/mTOR signaling pathway. Front Pharmacol 2022; 13: 905092. DOI URL

Item			Experimental group	Control group	P value
Men [n (%)]^a			83 (69.70)	35 (89.70)	0.0115^f
Age (years)^a			58.20±8.38	57.10±7.49	0.3366^g
Height (cm)^a			166.99±8.24	169.49±7.57	0.2074^g
Weight (kg)^a			70.92±9.67	71.18±10.23	0.8852^h
Had a clear history of old myocardial infarction, or PCI history, or bypass surgery history [n (%)]^a			51 (42.90)	18 (46.20)	0.7187ⁱ
Coronary angiography (results indicating at least one coronary artery stenosis with lumen stenosis ≥50%) or coronary CTA indicating lumen stenosis ≥50% [n (%)]^a			48 (40.30)	19 (48.70)	0.3580ⁱ
Results of exercise electrocardiogram examination support the diagnosis of coronary heart disease (male only) [n (%)]^a			22 (18.50)	7 (17.90)	0.9399ⁱ
Dynamic changes in electrocardiogram support angina pectoris attacks [n (%)]^a			6 (5.00)	1 (2.60)	1.0000^f
Combined medication [n (%)]^a			99 (83.20)	30 (76.90)	0.3800ⁱ
Had pre-study medications and other treatments [n (%)]^a			115 (96.60)	36 (92.30)	0.3650^f
Total score of SAQ (point)			50.89±8.01	52.02±6.93	0.4323^h
Individual score of SAQ (point)^a	Degree of physical activity limitation		49.49±12.18	49.00±10.95	0.9339^g
	Stable state of angina pectoris		50.21±6.09	51.28±8.01	0.4366^g
	Frequency of angina pectoris attacks		62.27±13.56	64.62±12.74	0.2868^g
	Degree of treatment satisfaction		55.51±15.04	55.66±13.69	1.0000^g
	Degree of disease awareness		36.97±18.90	39.53±18.21	0.6362^g
Treadmill exercise test	Termination time of exercise (s)^b		477.93±170.09	485.31±128.30	0.8854^h
	MET^b		6.89±2.38	7.16±2.27	0.6724^g
	Duration of ST segment depression ≥0.1mv (horizontal or downward-sloping type) (s)^c		323.41±158.79	288.13±99.55	0.5544^h
	Duration of restrictive angina pectoris attack (s)^d		299.37±126.59	493.33±128.77	0.0230^h
	Amplitude of maximum ST segment depression on electrocardiogram (mv)^e		0.16±0.09	0.11±0.07	0.1586^g
	RPP^b		207.88±47.82	199.19±37.74	0.4814^g
	Level of Duke treadmill score [n (%)]^b		46	13	0.4992^f
		low-risk	10 (21.70)	3 (23.10)
		medium-risk	29 (63.00)	10 (76.90)
		high-risk	7 (15.20)	0 (0.00)
	Maximum exercise heart rate (bpm)^b		139.43±27.81	132.15±26.50	0.5400^g
	Maximum exercise blood pressure (mm Hg)^b		152.70±18.87	154.15±19.86	0.8087^h
Number of nitroglycerin taken (tablets/one week)^a			0.85±1.38	0.67±1.30	0.4484^g

Item			Experimental group	Control group	P value
Men [n (%)]^a			83 (69.70)	35 (89.70)	0.0115^f
Age (years)^a			58.20±8.38	57.10±7.49	0.3366^g
Height (cm)^a			166.99±8.24	169.49±7.57	0.2074^g
Weight (kg)^a			70.92±9.67	71.18±10.23	0.8852^h
Had a clear history of old myocardial infarction, or PCI history, or bypass surgery history [n (%)]^a			51 (42.90)	18 (46.20)	0.7187ⁱ
Coronary angiography (results indicating at least one coronary artery stenosis with lumen stenosis ≥50%) or coronary CTA indicating lumen stenosis ≥50% [n (%)]^a			48 (40.30)	19 (48.70)	0.3580ⁱ
Results of exercise electrocardiogram examination support the diagnosis of coronary heart disease (male only) [n (%)]^a			22 (18.50)	7 (17.90)	0.9399ⁱ
Dynamic changes in electrocardiogram support angina pectoris attacks [n (%)]^a			6 (5.00)	1 (2.60)	1.0000^f
Combined medication [n (%)]^a			99 (83.20)	30 (76.90)	0.3800ⁱ
Had pre-study medications and other treatments [n (%)]^a			115 (96.60)	36 (92.30)	0.3650^f
Total score of SAQ (point)			50.89±8.01	52.02±6.93	0.4323^h
Individual score of SAQ (point)^a	Degree of physical activity limitation		49.49±12.18	49.00±10.95	0.9339^g
	Stable state of angina pectoris		50.21±6.09	51.28±8.01	0.4366^g
	Frequency of angina pectoris attacks		62.27±13.56	64.62±12.74	0.2868^g
	Degree of treatment satisfaction		55.51±15.04	55.66±13.69	1.0000^g
	Degree of disease awareness		36.97±18.90	39.53±18.21	0.6362^g
Treadmill exercise test	Termination time of exercise (s)^b		477.93±170.09	485.31±128.30	0.8854^h
	MET^b		6.89±2.38	7.16±2.27	0.6724^g
	Duration of ST segment depression ≥0.1mv (horizontal or downward-sloping type) (s)^c		323.41±158.79	288.13±99.55	0.5544^h
	Duration of restrictive angina pectoris attack (s)^d		299.37±126.59	493.33±128.77	0.0230^h
	Amplitude of maximum ST segment depression on electrocardiogram (mv)^e		0.16±0.09	0.11±0.07	0.1586^g
	RPP^b		207.88±47.82	199.19±37.74	0.4814^g
	Level of Duke treadmill score [n (%)]^b		46	13	0.4992^f
		low-risk	10 (21.70)	3 (23.10)
		medium-risk	29 (63.00)	10 (76.90)
		high-risk	7 (15.20)	0 (0.00)
	Maximum exercise heart rate (bpm)^b		139.43±27.81	132.15±26.50	0.5400^g
	Maximum exercise blood pressure (mm Hg)^b		152.70±18.87	154.15±19.86	0.8087^h
Number of nitroglycerin taken (tablets/one week)^a			0.85±1.38	0.67±1.30	0.4484^g

Item	Experimental group	Control group	P value
Degree of physical activity limitation^a	12±11	8±8	0.0422^b
Stable state of angina pectoris^a	47±11	38±23	0.0002^b
Frequency of angina pectoris attacks^a	28±17	18±12	0.0019^b
Degree of treatment satisfaction^a	21±20	17±18	0.1480^b
Degree of disease awareness^a	29±21	21±23	0.0581^b

Item	Experimental group	Control group	P value
Degree of physical activity limitation^a	12±11	8±8	0.0422^b
Stable state of angina pectoris^a	47±11	38±23	0.0002^b
Frequency of angina pectoris attacks^a	28±17	18±12	0.0019^b
Degree of treatment satisfaction^a	21±20	17±18	0.1480^b
Degree of disease awareness^a	29±21	21±23	0.0581^b

Item		Experimental group	Control group	P value
Termination time of exercise (s)^a		-14.23±136.42	52.43±153.57	0.5892^g
MET^b		0.49±2.07	0.63±1.80	0.8924^g
Duration of ST segment depression ≥ 0.1 mv (horizontal or downward-sloping type)^c		-78.00±103.32	-46.00±214.00	0.9114^g
Amplitude of maximum ST segment depression on electrocardiogram (mv)^d		0.01±0.09	-0.02±0.06	0.3936^h
RPP^b		3.21±69.95	-10.65±66.35	0.4625^g
Maximum exercise heart rate (bpm)^b		6.29±23.41	-16.00±39.99	0.0592^g
Maximum exercise blood pressure (mm Hg)^b		-3.31±28.38	10.18±13.50	0.1193^g
Duration of restrictive angina pectoris attack (s)^e		-35.83±163.09	250.67±96.44	0.0284^h
Level of Duke treadmill score Duke [n (%)]^b				1.0000ⁱ
	Low-risk	16 (38.10)	4 (36.40)
	Medium-risk	23 (54.80)	7 (63.60)
	High-risk	3 (7.10)	0 (0.00)
Conversion rate to a negative treadmill exercise test result after treatment [n (%)]^b		7 (16.70)	4 (36.40)	0.2104ⁱ
Angina-free rate after treatmentt [n (%)]^f		11 (64.70)	0 (0.00)	0.0737ⁱ

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