Clinical efficacy of Angong Jiangya pill (安宫降压丸) for grade 2 hypertension with liver-fire hyperactivity syndrome: a randomized, double-blind, placebo-controlled, multicenter trial

doi:10.19852/j.cnki.jtcm.2025.02.010

Abstract

Abstract:

OBJECTIVE: To investigate the efficacy and safety of Angong Jiangya pill (AGJY, 安宫降压丸) in the treatment of grade 2 hypertension with liver-fire hyperactivity syndrome.

METHODS: This multicenter, randomized, double-blind, placebo-controlled trial was conducted in eight medical institutions. Eligible patients with grade 2 hypertension were randomly allocated to receive AGJY or a placebo for 12 weeks. The primary outcome was the change in blood pressure (BP). The secondary outcomes were BP compliance rate, Traditional Chinese Medicine (TCM) symptoms, and Duchenne Hypertension Quality of Life Scale score.

RESULTS: Data were analyzed for 117 participants in the AGJY group and 118 participants in the placebo group. After 12 weeks of treatment, AGJY compared with placebo resulted in a higher and significant reduction in systolic/diastolic BP (－15.58 ± 10.16/－9.72 ± 7.41 vs －8.13 ± 8.28/－4.86 ± 5.68 mm Hg, P < 0.0001, < 0.0001, respectively). BP compliance rate (31.86% vs 19.13%, P= 0.027) was significantly higher in the AGJY group than in the placebo group. The AGJY group showed a significant reduction in TCM symptom score compared with the placebo group (10.82 ± 2.03 vs 7.83 ± 1.24, P< 0.0001). Single TCM syndrome clinical control rates of the primary symptoms (dizziness, headache, and irritability) were superior in the AGJY group (71.95%, 94.62%, 72.53%, respectively) compared with the placebo group (48.39%, 68.00%, 30.52%, respectively). Scores on the Duchenne Hypertension Quality of Life Scale showed a significant increase in the AGJY group compared with the placebo group (30.65 ± 21.06 vs 9.96 ± 10.72, P= 0.000). No serious adverse events occurred.

CONCLUSION: AGJY demonstrated efficacy in lowering BP, increasing the rate of BP compliance, and improving TCM symptoms and quality of life in patients with grade 2 hypertension liver-fire hyperactivity syndrome. However, further in-depth studies are required to determine the mechanism of TCM in treating hypertension.

Key words: hypertension, multicenter study, randomized controlled trial, liver-fire hyperactivity syndrome, Angong Jiangya

LAI Xiaolei, SHANG Juju, LIU Hongxu, HU Jing, LI Xiang, ZHANG Zhenmin, XING Wenlong. Clinical efficacy of Angong Jiangya pill (安宫降压丸) for grade 2 hypertension with liver-fire hyperactivity syndrome: a randomized, double-blind, placebo-controlled, multicenter trial[J]. Journal of Traditional Chinese Medicine, 2025, 45(2): 422-429.

Figures/Tables 6

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Item		AGJY group (n = 117)	Placebo group (n = 118)	P value
Age (years)		55.45±10.74	54.26±9.94	0.379^b
Women [n (%)]		58 (49.57)	72 (61.02）	0.078^c
Race [n (%)]	Han	115 (98.29)	116 (98.31)	1.000^d
	Other	2 (1.71)	2 (1.69)
Height (cm)		166.39±7.87	165.53±7.78	0.374^b
Weight (kg)		68.26±10.91	66.74±10.39^a	0.278^e
Temperature (℃)		36.44±0.24	36.41±0.26	0.449^b
Heart (times/min)		71.76±10.22	71.52±9.11	0.894^b
Respiration (times/min)		18±1.23	17.96±1.27	0.812^b
Medication regimen [n (%)]	CCB+ARB	80 (68.38)	76 (64.41)	0.520^c
	CCB+βblockers	37 (31.62)	42 (35.59)
BP (mm Hg)	Systolic	158.74±9.40	158.90±8.70	0.674^b
	Diastolic	95.28±8.84	94.52±9.50	0.995^b
TCM syndrome (scores)		12.98±4.46	13.02±4.45	0.926^b
Du’s Hypertension Life Scale (scores)		173.44±25.9	174.01±26.0	0.866^b

Item		AGJY group (n = 117)	Placebo group (n = 118)	P value
Age (years)		55.45±10.74	54.26±9.94	0.379^b
Women [n (%)]		58 (49.57)	72 (61.02）	0.078^c
Race [n (%)]	Han	115 (98.29)	116 (98.31)	1.000^d
	Other	2 (1.71)	2 (1.69)
Height (cm)		166.39±7.87	165.53±7.78	0.374^b
Weight (kg)		68.26±10.91	66.74±10.39^a	0.278^e
Temperature (℃)		36.44±0.24	36.41±0.26	0.449^b
Heart (times/min)		71.76±10.22	71.52±9.11	0.894^b
Respiration (times/min)		18±1.23	17.96±1.27	0.812^b
Medication regimen [n (%)]	CCB+ARB	80 (68.38)	76 (64.41)	0.520^c
	CCB+βblockers	37 (31.62)	42 (35.59)
BP (mm Hg)	Systolic	158.74±9.40	158.90±8.70	0.674^b
	Diastolic	95.28±8.84	94.52±9.50	0.995^b
TCM syndrome (scores)		12.98±4.46	13.02±4.45	0.926^b
Du’s Hypertension Life Scale (scores)		173.44±25.9	174.01±26.0	0.866^b

Item		CCB+ARB (n = 80)	CCB+β-blocker (n = 37)	P value
Age (years)		55.96±9.94	54.35±12.38	0.453^a
Women [n (%)]		40 (50.00)	18 (48.60）	0.892^b
Race [n (%)]	Han	79 (98.80)	116 (97.30)	0.534^c
	Other	1 (1.30)	2 (2.70)
Height (cm)		166.15±7.59	166.93±8.54	0.621^a
Weight (kg)		68.70±10.17	67.31±12.44	0.554^d
Temperature (℃)		36.44±0.25	36.43±0.23	0.896^a
Heart (times/min)		70.69±9.97	74.08±10.51	0.095^a
Respiration (times/min)		18.04±1.31	17.92±1.04	0.630^a
BP (mm Hg)	Systolic	158.98±9.36	158.30±9.61	0.719^a
	Diastolic	96.24±8.96	93.24±8.31	0.088^a
TCM syndrome (scores)		12.59±4.51	13.84±4.28	0.159^a
Du’s Hypertension Life Scale (scores)		172.40±27.56	175.70±22.24	0.524^a

Item		CCB+ARB (n = 80)	CCB+β-blocker (n = 37)	P value
Age (years)		55.96±9.94	54.35±12.38	0.453^a
Women [n (%)]		40 (50.00)	18 (48.60）	0.892^b
Race [n (%)]	Han	79 (98.80)	116 (97.30)	0.534^c
	Other	1 (1.30)	2 (2.70)
Height (cm)		166.15±7.59	166.93±8.54	0.621^a
Weight (kg)		68.70±10.17	67.31±12.44	0.554^d
Temperature (℃)		36.44±0.25	36.43±0.23	0.896^a
Heart (times/min)		70.69±9.97	74.08±10.51	0.095^a
Respiration (times/min)		18.04±1.31	17.92±1.04	0.630^a
BP (mm Hg)	Systolic	158.98±9.36	158.30±9.61	0.719^a
	Diastolic	96.24±8.96	93.24±8.31	0.088^a
TCM syndrome (scores)		12.59±4.51	13.84±4.28	0.159^a
Du’s Hypertension Life Scale (scores)		172.40±27.56	175.70±22.24	0.524^a

Variable	AGJY (n = 117)	Placebo (n = 118)	P value
After the 2-week treatment
Systolic	－5±7	－6±8	0.324
Diastolic	－4±6	－3±5	0.1613
After the 4-week treatment
Systolic	－9±9	－7±8	0.024^a
Diastolic	－6±7	－5±6	0.178
After the 8-week treatment
Systolic	－12±10	－8±8	0.0007^a
Diastolic	－7 ±7	－5 ±6	0.006^a
After the 12-week treatment
Systolic	－16±10	－8±8	<0.0001^a
Diastolic	－10±7	－5±6	<0.0001^a

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