Guanxin Danshen Dripping Pills Improve Quality of Life and Cardiovascular Prognoses of CHD Patients after PCI with Anxiety or Depression (GLAD Study): A Randomized Double-Blind Placebo-Controlled Study.
10.1007/s11655-022-3688-3
- Author:
Cheng-Long WANG
1
;
Na HUAN
1
;
Pei-Li WANG
1
;
Qing-Shan GENG
2
;
Wen-Lin MA
3
;
Li-Hong MA
4
;
Hong-Yan JIANG
5
;
Xiao-Ping MENG
6
;
Da-Wu ZHANG
1
;
Xiao-Jiang GOU
1
;
Da-Yi HU
7
;
Ke-Ji CHEN
8
Author Information
1. Department of Cardiovascular Disease, Xiyuan Hospital, Chinese Academy of Chinese Medical Sciences, Beijing, 100091, China.
2. Department of Cardiovascular Disease, Guangdong Provincial People's Hospital, Guangzhou, 510055, China.
3. Department of Cardiovascular Disease, Shanghai Tongji Hospital, Shanghai, 200065, China.
4. Department of Cardiovascular Disease, Fuwai Hospital, Chinese Academy of Medical Sciences, Beijing, 100037, China.
5. Department of Cardiovascular Disease, Beijing First Hospital of Integrated Chinese and Western Medicine, Beijing, 100020, China.
6. Department of Cardiovascular Disease, Affiliated Hospital of Changchun University of Chinese Medicine, Changchun, 130021, China.
7. Department of Cardiovascular Disease, People's Hospital of Peking University, Beijing, 100044, China.
8. Department of Cardiovascular Disease, Xiyuan Hospital, Chinese Academy of Chinese Medical Sciences, Beijing, 100091, China. kjchenvip@163.com.
- Publication Type:Journal Article
- Keywords:
Chinese medicine;
clinical efficacy;
coronary heart disease;
depression and anxiety state;
percutaneous coronary intervention
- MeSH:
Humans;
Percutaneous Coronary Intervention/adverse effects*;
Quality of Life;
Depression;
Coronary Disease/drug therapy*;
Drugs, Chinese Herbal/therapeutic use*;
Angina Pectoris/drug therapy*;
Prognosis;
Anxiety;
Treatment Outcome;
Double-Blind Method
- From:
Chinese journal of integrative medicine
2023;29(3):195-204
- CountryChina
- Language:English
-
Abstract:
OBJECTIVE:To assess the efficacy and safety of Guanxin Danshen Dripping Pills (GXDS) in the treatment of depression or anxiety in patients with coronary heart disease (CHD) after percutaneous coronary intervention (PCI).
METHODS:From September 2017 to June 2019, 200 CHD patients after PCI with depression and anxiety were included and randomly divided into GXDS (100 cases) and placebo control groups (100 cases) by block randomization and a random number table. Patients in the GXDS and control groups were given GXDS and placebo, respectively, 0.4 g each time, 3 times daily for 12 weeks. The primary outcomes were scores of Patient Health Questionnaire-9 (PHQ-9), Generalized Anxiety Scale (GAD-7) and the Seattle Angina Pectoris Scale (SAQ). The secondary outcomes included 12 Health Survey Summary Form (SF-12) scores and the first onset time and incidence of major adverse cardiovascular events (MACEs). Other indices including blood pressure, blood lipids, microcirculation and inflammatory-related indices, etc. were monitored at baseline, week 4, and week 12.
RESULTS:In the full analysis set (200 cases), after treatment, the PHQ-9 and GAD-7 scores in the GXDS group were considerably lower than those in the control group (P<0.05). Compared with the baseline, the total PHQ-9 scores of the experimental and control groups decreased by 3.97 and 1.18, respectively. The corrected mean difference between the two groups was -2.78 (95% CI: -3.47, -2.10; P<0.001). The total GAD-7 score in the GXDS group decreased by 3.48% compared with the baseline level, while that of the placebo group decreased by 1.13%. The corrected mean difference between the two groups was -2.35 (95% CI: -2.95, -1.76; P<0.001). The degree of improvement in SAQ score, SF-12 score, endothelin and high-sensitive C-reactive protein levels in the GXDS group were substantially superior than those in the placebo group, and the differences between the two groups were statistically significant (P<0.05). Similar results were obtained in the per protocol population analysis of 177 patients. Three cases of MACES were reported in this study (1 in the GXDS group and 2 in the placebo group), and no serious adverse events occurred.
CONCLUSIONS:GXDS can significantly alleviate depression and anxiety, relieve symptoms of angina, and improve quality of life in patients with CHD after PCI. (Registration No. ChiCTR1800014291).
