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

Figure 1 Flow diagram illustrating the number of patients in each group throughout the study SGR: Shenshu Guanxin recipe granules.

Table 1 Baseline characteristics of the included patients (

\bar{x}

± s)

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

Table 1 Baseline characteristics of the included patients ( $\bar{x}$ ± s)

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

Table 2 Exercise measurements during the treadmill exercise test (

\bar{x}

± s)

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

Table 2 Exercise measurements during the treadmill exercise test ( $\bar{x}$ ± s)

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

Table 3 Results of the seattle angina questionnaire (

\bar{x}

± s)

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

Table 3 Results of the seattle angina questionnaire ( $\bar{x}$ ± s)

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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