Randomized Double-blind Placebo-controlled Study on Clinical Efficacy and Mechanism of Shexiang Baoxinwan in Treating Stable Angina Pectoris Complicated with Anxiety and Depression in Coronary Artery Disease
10.13422/j.cnki.syfjx.20251093
- VernacularTitle:麝香保心丸治疗冠心病稳定型心绞痛合并焦虑抑郁状态的随机双盲安慰剂对照的临床疗效及作用机制
- Author:
Jie WANG
1
;
Linzi LONG
1
;
Zhiru ZHAO
1
;
Feifei LIAO
2
;
Jieming LU
2
;
Tianjiao LIU
1
;
Yuxuan PENG
1
;
Hua QU
1
;
Changgeng FU
1
Author Information
1. Xiyuan Hospital，China Academy of Chinese Medical Sciences，Beijing 100091，China
2. Graduate School，Beijing University of Chinese Medicine，Beijing 100029，China
- Publication Type:Journal Article
- Keywords:
Shexiang Baoxinwan;
stable angina pectoris;
anxiety and depression;
inflammatory marker;
Qi stagnation and blood stasis syndrome
- From:
Chinese Journal of Experimental Traditional Medical Formulae
2025;31(13):159-169
- CountryChina
- Language:Chinese
-
Abstract:
ObjectiveTo evaluate the efficacy of Shexiang Baoxinwan in treating stable angina pectoris with Qi stagnation and blood stasis syndrome in patients with coronary artery disease （CAD） complicated with anxiety and depression and explore its underlying mechanisms. MethodsThis study employed a randomized， double-blind， and placebo-controlled clinical trial design. Patients admitted to the hospital were randomly assigned to the observation group and the control group， with 52 patients in each group. Patients in the observation and control groups received Shexiang Baoxinwan and placebo， respectively， both in combination with conventional Western medication. The dose was 45.0 mg， three times daily， for a total duration of eight weeks. The primary outcome was the Seattle Angina Questionnaire （SAQ） scores before and after treatment. Secondary outcomes included changes in traditional Chinese medicine （TCM） syndrome score， the patient health questionnaire-9 （PHQ-9）， generalized anxiety disorder-7 （GAD-7）， inflammatory markers ［interleukin-18 （IL-18）， interleukin-10 （IL-10）， tumor necrosis factor-alpha （TNF-α）， CD40， etc.］， monoamine neurotransmitters ［e.g.， dopamine （DA）］， vascular endothelial function markers ［e.g.， endothelin-1（ET-1）］， adipokines， and ischemia-modified albumin （IMA）. Adverse reactions were also recorded. ResultsA total of 92 patients completed the study， with 44 in the observation group and 48 in the control group. Compared with baseline， both groups showed significant decreases in PHQ-9， GAD-7， and TCM syndrome scores following treatment （P<0.05）， along with a significant increase in SAQ scores （P<0.05）. In the observation group， DA levels were significantly increased （P<0.05）， while levels of IL-18， TNF-α， CD40， ET-1， and IMA were decreased （P<0.05）. In contrast， the control group exhibited significantly increased CD40 levels （P<0.05）. Compared with the control group after treatment， the observation group showed significant improvements in the SAQ dimensions of physical limitation， angina stability， treatment satisfaction， and disease perception， as well as in TCM syndrome score， PHQ-9 score， IL-18， CD40， ET-1， and IMA （P<0.05）. No adverse reactions were observed in either group during treatment. ConclusionShexiang Baoxinwan can improve anxiety and depression， alleviate angina symptoms， and reduce TCM symptoms of Qi stagnation and blood stasis in CAD patients. The mechanism may involve anti-inflammation， improvement of vascular endothelial function， reduction of IMA， and increase of monoamine neurotransmitter levels.
