Efficacy and Safety of Yangxue Qingnao Pills Combined with Amlodipine in Treatment of Hypertensive Patients with Blood Deficiency and Gan-Yang Hyperactivity: A Multicenter, Randomized Controlled Trial.

Fan WANG; Hai-Qing GAO; Zhe LYU; Xiao-Ming WANG; Hui HAN; Yong-Xia WANG; Feng LU; Bo DONG; Jun PU; Feng LIU; Xiu-Guang ZU; Hong-Bin LIU; Li YANG; Shao-Ying ZHANG; Yong-Mei YAN; Xiao-Li WANG; Jin-Han CHEN; Min LIU; Yun-Mei YANG; Xiao-Ying LI

Return

Efficacy and Safety of Yangxue Qingnao Pills Combined with Amlodipine in Treatment of Hypertensive Patients with Blood Deficiency and Gan-Yang Hyperactivity: A Multicenter, Randomized Controlled Trial.

Author: Fan WANG ¹ ; Hai-Qing GAO ² ; Zhe LYU ³ ; Xiao-Ming WANG ⁴ ; Hui HAN ⁵ ; Yong-Xia WANG ⁶ ; Feng LU ⁷ ; Bo DONG ⁸ ; Jun PU ⁹ ; Feng LIU ¹⁰ ; Xiu-Guang ZU ¹¹ ; Hong-Bin LIU ¹ ; Li YANG ¹² ; Shao-Ying ZHANG ¹³ ; Yong-Mei YAN ¹⁴ ; Xiao-Li WANG ¹⁵ ; Jin-Han CHEN ¹⁶ ; Min LIU ¹⁷ ; Yun-Mei YANG ¹⁸ ; Xiao-Ying LI ^{19
,

20}
Author Information

1. Department of the Cardiology, Chinese PLA General Hospital, Beijing, 100853, China.
2. Department of Geriatric, Qilu Hospital of Shandong University, Jinan, 250012, China.
3. Department of Encephalopathy, Zhumadian Traditional Chinese Medicine Hospital, Zhumadian, Henan Province, 463000, China.
4. Department of Geriatric, Xijing Hospital of Air Force Medical University, Xi'an, 710032, China.
5. Department of Geriatric, the First Affiliated Hospital of Harbin Medical University, Harbin, 150001, China.
6. Department of the Cardiology, the First Affiliated Hospital of Henan University of Chinese Medicine, Zhengzhou, 450000, China.
7. Department of the Cardiology, Affiliated Hospital of Shandong University of Traditional Chinese Medicine, Jinan, 250014, China.
8. Department of the Cardiology, the Second Affiliated Hospital of Liaoning University of Traditional Chinese Medicine, Shenyang, 110034, China.
9. Department of the Cardiology, Affiliated Hospital of North Sichuan Medical College, Nanchong, Sichuan Province, 637000, China.
10. Department of Geriatric, Guangzhou First People's Hospital, Guangzhou, 510180, China.
11. Department of the Cardiology, the Second Hospital of Hebei Medical University, Shijiazhuang, 050000, China.
12. Department of Geriatric, Yan'an Hospital of Kunming City, Kunming, 650051, China.
13. General Department, the Central Hospital of Wuhan, Wuhan, 430014, China.
14. Department of Encephalopathy, Affiliated Hospital of Shaanxi University of Chinese Medicine, Xianyang, Shanxi Province, 712000, China.
15. Department of Geriatric, the First Affiliated Hospital of Jinzhou Medical University, Jinzhou, Liaoning Province, 121001, China.
16. Healcare Department for Cadres, the First Affiliated Hospital of Xiamen University, Xiamen, Fujian Province, 361003, China.
17. Specialized Department of Hypertension, Henan Provincial People's Hospital, Zhengzhou, 450003, China.
18. Department of Geriatric, the First Affiliated Hospital of Zhejiang University School of Medicine, Hangzhou, 310003, China.
19. Department of the Cardiology, Chinese PLA General Hospital, Beijing, 100853, China. xyli301@
20. com.
Publication Type:Multicenter Study
Keywords: Chinese medicine syndrome score; Yangxue Qingnao Pills; blood pressure variability; hypertension with blood deficiency and Gan-yang hyperactivity
MeSH: Humans; Amlodipine/adverse effects*; Drugs, Chinese Herbal/adverse effects*; Male; Female; Hypertension/complications*; Middle Aged; Treatment Outcome; Drug Therapy, Combination; Adult; Blood Pressure/drug effects*; Double-Blind Method; Aged; Antihypertensive Agents/adverse effects*
From: Chinese journal of integrative medicine 2025;31(3):195-205
CountryChina
Language:English
Abstract: OBJECTIVE:To evaluate the clinical efficacy and safety of Yangxue Qingnao Pills (YXQNP) combined with amlodipine in treating patients with grade 1 hypertension.
METHODS:This is a multicenter, randomized, double-blind, and placebo-controlled study. Adult patients with grade 1 hypertension of blood deficiency and Gan (Liver)-yang hyperactivity syndrome were randomly divided into the treatment or the control groups at a 1:1 ratio. The treatment group received YXQNP and amlodipine besylate, while the control group received YXQNP's placebo and amlodipine besylate. The treatment duration lasted for 180 days. Outcomes assessed included changes in blood pressure, Chinese medicine (CM) syndrome scores, symptoms and target organ functions before and after treatment in both groups. Additionally, adverse events, such as nausea, vomiting, rash, itching, and diarrhea, were recorded in both groups.
RESULTS:A total of 662 subjects were enrolled, of whom 608 (91.8%) completed the trial (306 in the treatment and 302 in the control groups). After 180 days of treatment, the standard deviations and coefficients of variation of systolic and diastolic blood pressure levels were lower in the treatment group compared with the control group. The improvement rates of dizziness, headache, insomnia, and waist soreness were significantly higher in the treatment group compared with the control group (P<0.05). After 30 days of treatment, the overall therapeutic effects on CM clinical syndromes were significantly increased in the treatment group as compared with the control group (P<0.05). After 180 days of treatment, brachial-ankle pulse wave velocity, ankle brachial index and albumin-to-creatinine ratio were improved in both groups, with no statistically significant differences (P>0.05). No serious treatment-related adverse events occurred during the study period.
CONCLUSIONS:Combination therapy of YXQNP with amlodipine significantly improved symptoms such as dizziness and headache, reduced blood pressure variability, and showed a trend toward lowering urinary microalbumin in hypertensive patients. These findings suggest that this regimen has good clinical efficacy and safety. (Registration No. ChiCTR1900022470).