Shexiang Tongxin Dropping Pill Improves Stable Angina Patients with Phlegm-Heat and Blood-Stasis Syndrome: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial.

Ying-Qiang ZHAO; Yong-Fa XING; Ke-Yong ZOU; Wei-Dong JIANG; Ting-Hai DU; Bo CHEN; Bao-Ping YANG; Bai-Ming QU; Li-Yue WANG; Gui-Hong GONG; Yan-Ling SUN; Li-Qi WANG; Gao-Feng ZHOU; Yu-Gang DONG; Min CHEN; Xue-Juan ZHANG; Tian-Lun YANG; Min-Zhou ZHANG; Ming-Jun ZHAO; Yue DENG; Chang-Jiang XIAO; Lin WANG; Bao-He WANG

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Shexiang Tongxin Dropping Pill Improves Stable Angina Patients with Phlegm-Heat and Blood-Stasis Syndrome: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial.

Author: Ying-Qiang ZHAO ¹ ; Yong-Fa XING ¹ ; Ke-Yong ZOU ² ; Wei-Dong JIANG ³ ; Ting-Hai DU ⁴ ; Bo CHEN ⁵ ; Bao-Ping YANG ⁶ ; Bai-Ming QU ⁷ ; Li-Yue WANG ⁸ ; Gui-Hong GONG ⁹ ; Yan-Ling SUN ¹⁰ ; Li-Qi WANG ¹¹ ; Gao-Feng ZHOU ¹² ; Yu-Gang DONG ¹³ ; Min CHEN ¹⁴ ; Xue-Juan ZHANG ¹⁵ ; Tian-Lun YANG ¹⁶ ; Min-Zhou ZHANG ¹⁷ ; Ming-Jun ZHAO ¹⁸ ; Yue DENG ¹⁹ ; Chang-Jiang XIAO ²⁰ ; Lin WANG ²¹ ; Bao-He WANG ^{22
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Author Information

1. Department of Cardiology, the Second Affiliated Hospital of Tianjin University of Chinese Medicine, Tianjin, 300143, China.
2. Department of Cardiology, Nanshi Hospital of Nanyang, Nanyang, Henan Province, 473000, China.
3. Department of Cardiology, Nantong Hospital of Traditional Chinese Medicine, Nantong, Jiangsu Province, 226001, China.
4. Department of Cardiology, the First Affiliated Hospital of Henan University of Traditional Chinese Medicine, Zhengzhou, 450000, China.
5. Department of Cardiology, the First Affiliated Hospital of Heilongjiang University of Traditional Chinese Medicine, Haerbin, 150000, China.
6. Department of Cardiology, Gansu Provincial Hospital of Traditional Chinese Medicine, Lanzhou, 730000, China.
7. Department of Cardiology, Zhejiang Provincial People's Hospital, Hangzhou, 314408, China.
8. Department of Cardiology, Wuhan University of Science and Technology Affiliated Wuchang Hospital, Wuhan, 430000, China.
9. Department of Cardiology, the First Affiliated Hospital of Henan University, Kaifeng, Henan Province, 475000, China.
10. Department of Cardiology, Luoyang Hospital of Traditional Chinese Medicine, Luoyang, Henan Province, 471000, China.
11. Department of Cardiology, Kaifeng People's Hospital, Kaifeng, Henan Province, 475000, China.
12. Department of Integrated Traditional Chinese and Western Medicine, West China Hospital of Sichuan University, Chengdu, 610000, China.
13. Department of Cardiology, the First Affiliated Hospital of Sun Yat-sen University, Guangzhou, 510000, China.
14. Department of Geratology, Affiliated Hospital of Liaoning University of Traditional Chinese Medicine, Shenyang, 110000, China.
15. Department of General Medicine, the Affiliated Hospital of Qingdao University, Qingdao, Shandong Province, 266000, China.
16. Department of Cardiology, Xiangya Hospital of Central South University, Changsha, 410008, China.
17. Department of Critical Care Medicine, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou, 510120, China.
18. Department of Cardiology, Affiliated Hospital of Shaanxi University of Chinese Medicine, Xianyang, Shaanxi Province, 712000, China.
19. Department of Cardiology, Affiliated Hospital of Changchun University of Traditional Chinese Medicine, Changchun, 130000, China.
20. Department of Cardiology, the Affiliated Hospital of Hunan Academy of Traditional Chinese Medicine, Changsha, 410000, China.
21. Department of Cardiology, Tongji Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology, Wuhan, 430000, China.
22. Department of Cardiology, the First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine, Tianjin, 300041, China. wangbaohe2024@
23. com.
Publication Type:Multicenter Study
Keywords: Chinese medicine; Shexiang Tongxin Dropping Pill; coronary artery disease; excercise tolerance; phlegm-heat and blood stasis syndrome; randomized controlled trial; stable angina
MeSH: Humans; Double-Blind Method; Drugs, Chinese Herbal/adverse effects*; Male; Female; Middle Aged; Angina, Stable/physiopathology*; Aged; Syndrome; Treatment Outcome; Placebos; Tablets
From: Chinese journal of integrative medicine 2025;31(8):685-693
CountryChina
Language:English
Abstract: OBJECTIVE:To evaluate the efficacy and safety of Shexiang Tongxin Dropping Pill (STDP) in treating stable angina patients with phlegm-heat and blood-stasis syndrome by exercise duration and metabolic equivalents.
METHODS:This multicenter, randomized, double-blind, placebo-controlled clinical trial enrolled stable angina patients with phlegm-heat and blood-stasis syndrome from 22 hospitals. They were randomized 1:1 to STDP (35 mg/pill, 6 pills per day) or placebo for 56 days. The primary outcome was the exercise duration and metabolic equivalents (METs) assessed by the standard Bruce exercise treadmill test after 56 days of treatment. The secondary outcomes included the total angina symptom score, Chinese medicine (CM) symptom scores, Seattle Angina Questionnaire (SAQ) scores, changes in ST-T on electrocardiogram and adverse events (AEs).
RESULTS:This trial enrolled 309 patients, including 155 and 154 in the STDP and placebo groups, respectively. STDP significantly prolonged exercise duration with an increase of 51.0 s, compared to a decrease of 12.0 s with placebo (change rate: -11.1% vs. 3.2%, P<0.01). The increase in METs was significantly greater in the STDP group than in the placebo group (change: -0.4 vs. 0.0, change rate: -5.0% vs. 0.0%, P<0.01). The improvement of total angina symptom scores (25.0% vs. 0.0%), CM symptom scores (38.7% vs. 11.8%), reduction of nitroglycerin consumption (100.0% vs. 11.3%), and all domains of SAQ, were significantly greater with STDP than placebo (all P<0.01). The changes in Q-T intervals at 28 and 56 days from baseline were similar between the two groups (both P>0.05). Twenty-five participants (16.3%) with STDP and 16 (10.5%) with placebo experienced AEs (P=0.131), with no serious AEs observed.
CONCLUSION:STDP could improve exercise tolerance in patients with stable angina and phlegm-heat and blood stasis syndrome, with a favorable safety profile. (Registration No. ChiCTR-IPR-15006020).