Evidence-Based Complementary and Alternative Medicine

Research Article

Efficacy and Safety of Yangyin Shuxin Decoction—a Chinese Herbal Medicine Formula For Heart Failure with Preserved Ejection Fraction: A Randomized Controlled Trial

Table 2

Comparison of the primary and secondary endpoints in the YYSX group and control group between baseline and 2 weeks.


Variables	YYSX group (n = 31)				Control group (n = 32)
Variables	Baseline	Week 2	Δ	P^a	Baseline	Week 2	Δ	P^a	P^b

Primary
Peak VO₂ (ml/kg/min)	11.19 ± 3.35	12.04 ± 3.41	0.84 (0.15 to 1.53)	0.018	11.56 ± 3.23	11.02 ± 3.33	−0.55 (−1.39 to 0.29)	0.192	0.013
Secondary
CPET
VO₂@AT (ml/kg/min)	8.36 ± 2.23	8.75 ± 2.47	0.39 (−0.27 to 1.05)	0.232	8.85 ± 2.09	8.57 ± 2.63	0.28 (−0.87 to 0.32)	0.352	0.167
VE/VCO₂ slope	31.34 ± 4.87	30.36 ± 5.66	−0.98 (−2.51 to 0.54)	0.198	30.29 ± 5.19	29.74 ± 6.17	−0.55 (−3.02 to 1.93)	0.656	0.980
Echocardiography
LAVI (ml/m²)	25.80 (10.00)	24.11 (8.70)		0.039	23.00 (8.87)	23.95 (7.93)		0.362	0.483
LVMI (mg/m²)	107.41 (18.23)	102.68 (14.84)		0.034	103.40 (17.63)	105.79 (22.53)		0.412	0.945
IVRT (ms)	85 (26)	102 (42)		<0.001	98 (42.75)	103 (38)		0.876	0.752
E/e’	11.57 (7.34)	10.89 (4.71)		0.103	10.63 (3.20)	10.12 (3.58)		0.094	0.268
EDT (ms)	178 (53)	180 (69)		0.538	174.5 (64.5)	189.5 (66)		0.368	0.842
BNP (pg/ml)	72 (85.3)	51.4 (73.8)		<0.001	106.5 (81.68)	57.7 (94.93)		0.066	0.454
PFT
MVV (%)	52.26 ± 21.19	60.06 ± 23.71	7.81 (3.11 to 12.50)	0.002	59.50 ± 25.23	59.81 ± 26.17	0.31 (−4.25 to 4.88)	0.890	0.036
FVC (%)	70.94 ± 18.26	75.32 ± 16.88	4.39 (−1.90 to 10.67)	0.164	72.08 ± 15.48	73.95 ± 15.93	1.88 (−3.48 to 7.23)	0.481	0.578
FEV1 (%)	75.61 ± 20.67	79.90 ± 17.72	4.29 (−1.36 to 9.95)	0.132	75.47 ± 18.64	76.64 ± 18.84	1.17 (−2.53 to 4.88)	0.524	0.295
IC	1.96 ± 0.79	2.11 ± 0.66	0.15 (−0.09 to 0.38)	0.219	1.98 ± 0.53	1.88 ± 0.65	−.0.09 (−0.27 to 0.08)	0.270	0.071
EQ-5D-5 L
TTO score	0.806 ± 0.138	0.870 ± 0.141	0.06 (0.02 to 0.11)	0.004	0.837 ± 0.153	0.847 ± 0.163	0.01 (−0.03 to 0.05)	0.572	0.073
EQ-VAS score	67.03 ± 14.24	71.13 ± 13.95	4.10 (2.02 to 6.17)	<0.001	70.94 ± 13.16	70.94 ± 13.70	0.00 (−1.89 to 1.89)	1.000	0.007
TCMFDIS score	67.97 ± 26.49	49.74 ± 24.73	−18.23 (−24.16 to -12.29)	<0.001	63.94 ± 27.12	64.16 ± 27.15	0.22 (−5.38 to 5.82)	0.937	<0.001

Data are expressed by mean ± SD or median (interquartile range). a refers to the analysis of paired T-test. Comparison between baseline versus week 2. b refers to adjusted treatment differences estimates from an analysis of ANCOVA test, with intervention condition as the group factor and preintervention value as a covariate. Comparison between YYSX group versus control group in postintervention. Peak VO₂, peak oxygen consumption; CPET, cardiopulmonary exercise test; VO₂@AT, oxygen uptake at anaerobic threshold; VE/VCO₂ slope, the minute ventilation/carbon dioxide production slope; LAVI, left atrial volume index; LVMI, left ventricular mass index; IVRT, isovolumic relaxation time; E/e’, the ratio between early diastolic transmitral flow and mitral annular velocity; EDT, mitral E deceleration time; BNP, brain natriuretic peptide; PFT, pulmonary function test; MVV, maximum voluntary ventilation; FEV1, forced expiratory volume in 1 second; FVC, forced vital capacity; IC, inspiratory capacity; EQ-5D-5 L, European Quality of Life Five-Dimension Five-Level Scale; TTO, time trade-off; EA-VAS, EQ-visual analogue scale; TCMFDIS, Traditional Chinese Medicine Four-Dimensional Diagnostic Information Scale.