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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
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 depre...
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| Published in: | Chinese journal of integrative medicine 2023-03, Vol.29 (3), p.195-204 |
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| creator | Wang, Cheng-long Huan, Na Wang, Pei-li Geng, Qing-shan Ma, Wen-lin Ma, Li-hong Jiang, Hong-yan Meng, Xiao-ping Zhang, Da-wu Gou, Xiao-jiang Hu, Da-yi Chen, Ke-ji |
| description | 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 |
| doi_str_mv | 10.1007/s11655-022-3688-3 |
| format | article |
| fullrecord | <record><control><sourceid>proquest_cross</sourceid><recordid>TN_cdi_proquest_miscellaneous_2729514495</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><sourcerecordid>2729514495</sourcerecordid><originalsourceid>FETCH-LOGICAL-c2593-2bf94cf398d0663fd2547389d8fc23b9bfb4f4ad6ace60d7d17bad433fc5eafd3</originalsourceid><addsrcrecordid>eNp9UcmO1DAQjRCIWeADuCAfh0PAS5yFW5NAT0st0Wxny4nLPR45drCTgZ4_5K9w0wNHTlXS21T1suwFwa8JxtWbSEjJeY4pzVlZ1zl7lJ2TpmE5LjB9nPayomkn_Cy7iPEWY16VmD_NzljJMCl4eZ79Wi_S_TQOddLFG0gzmGkybo92xtqINuMU_B2gT4u0Zj4gr9HWaEDSKdTKoIy_k3FYrAxoF_ze-QjxSGqvO7STswE3RyT1DAlvN-iHmW_QKgXC0SugDqYAMRrv0NV6u-rQl3lRh1dv0Qp9ThF-NPegUOeX3kL-zpqUurNygN7nrXdz8NYm_I_oWfZESxvh-cO8zL59eP-1vc63H9ebdrXNB8rTa2ivm2LQrKkVLkumFeVFxepG1XqgrG963Re6kKpMKSVWlSJVL1XBmB44SK3YZXZ18k2P-b5AnMVo4gDWSgd-iYJWtOGkKBqeqOREHYKPMYAWUzCjDAdBsDg2KE4NitSgODYoWNK8fLBf-hHUP8XfyhKBnggxQW4PQdz6Jbh08n9cfwNnD6lu</addsrcrecordid><sourcetype>Aggregation Database</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>2729514495</pqid></control><display><type>article</type><title>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</title><source>Springer Nature</source><creator>Wang, Cheng-long ; Huan, Na ; Wang, Pei-li ; Geng, Qing-shan ; Ma, Wen-lin ; Ma, Li-hong ; Jiang, Hong-yan ; Meng, Xiao-ping ; Zhang, Da-wu ; Gou, Xiao-jiang ; Hu, Da-yi ; Chen, Ke-ji</creator><creatorcontrib>Wang, Cheng-long ; Huan, Na ; Wang, Pei-li ; Geng, Qing-shan ; Ma, Wen-lin ; Ma, Li-hong ; Jiang, Hong-yan ; Meng, Xiao-ping ; Zhang, Da-wu ; Gou, Xiao-jiang ; Hu, Da-yi ; Chen, Ke-ji</creatorcontrib><description>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)</description><identifier>ISSN: 1672-0415</identifier><identifier>EISSN: 1993-0402</identifier><identifier>DOI: 10.1007/s11655-022-3688-3</identifier><identifier>PMID: 36301456</identifier><language>eng</language><publisher>Singapore: Springer Nature Singapore</publisher><subject>Angina Pectoris - drug therapy ; Anxiety ; Coronary Disease - drug therapy ; Depression ; Double-Blind Method ; Drugs, Chinese Herbal - therapeutic use ; Humans ; Medicine ; Medicine & Public Health ; Original Article ; Percutaneous Coronary Intervention - adverse effects ; Prognosis ; Quality of Life ; Treatment Outcome</subject><ispartof>Chinese journal of integrative medicine, 2023-03, Vol.29 (3), p.195-204</ispartof><rights>The Chinese Journal of Integrated Traditional and Western Medicine Press and Springer-Verlag GmbH Germany, part of Springer Nature 2022</rights><rights>2022. The Chinese Journal of Integrated Traditional and Western Medicine Press and Springer-Verlag GmbH Germany, part of Springer Nature.</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c2593-2bf94cf398d0663fd2547389d8fc23b9bfb4f4ad6ace60d7d17bad433fc5eafd3</citedby><cites>FETCH-LOGICAL-c2593-2bf94cf398d0663fd2547389d8fc23b9bfb4f4ad6ace60d7d17bad433fc5eafd3</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,780,784,27924,27925</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/36301456$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Wang, Cheng-long</creatorcontrib><creatorcontrib>Huan, Na</creatorcontrib><creatorcontrib>Wang, Pei-li</creatorcontrib><creatorcontrib>Geng, Qing-shan</creatorcontrib><creatorcontrib>Ma, Wen-lin</creatorcontrib><creatorcontrib>Ma, Li-hong</creatorcontrib><creatorcontrib>Jiang, Hong-yan</creatorcontrib><creatorcontrib>Meng, Xiao-ping</creatorcontrib><creatorcontrib>Zhang, Da-wu</creatorcontrib><creatorcontrib>Gou, Xiao-jiang</creatorcontrib><creatorcontrib>Hu, Da-yi</creatorcontrib><creatorcontrib>Chen, Ke-ji</creatorcontrib><title>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</title><title>Chinese journal of integrative medicine</title><addtitle>Chin. J. Integr. Med</addtitle><addtitle>Chin J Integr Med</addtitle><description>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)</description><subject>Angina Pectoris - drug therapy</subject><subject>Anxiety</subject><subject>Coronary Disease - drug therapy</subject><subject>Depression</subject><subject>Double-Blind Method</subject><subject>Drugs, Chinese Herbal - therapeutic use</subject><subject>Humans</subject><subject>Medicine</subject><subject>Medicine & Public Health</subject><subject>Original Article</subject><subject>Percutaneous Coronary Intervention - adverse effects</subject><subject>Prognosis</subject><subject>Quality of Life</subject><subject>Treatment Outcome</subject><issn>1672-0415</issn><issn>1993-0402</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2023</creationdate><recordtype>article</recordtype><recordid>eNp9UcmO1DAQjRCIWeADuCAfh0PAS5yFW5NAT0st0Wxny4nLPR45drCTgZ4_5K9w0wNHTlXS21T1suwFwa8JxtWbSEjJeY4pzVlZ1zl7lJ2TpmE5LjB9nPayomkn_Cy7iPEWY16VmD_NzljJMCl4eZ79Wi_S_TQOddLFG0gzmGkybo92xtqINuMU_B2gT4u0Zj4gr9HWaEDSKdTKoIy_k3FYrAxoF_ze-QjxSGqvO7STswE3RyT1DAlvN-iHmW_QKgXC0SugDqYAMRrv0NV6u-rQl3lRh1dv0Qp9ThF-NPegUOeX3kL-zpqUurNygN7nrXdz8NYm_I_oWfZESxvh-cO8zL59eP-1vc63H9ebdrXNB8rTa2ivm2LQrKkVLkumFeVFxepG1XqgrG963Re6kKpMKSVWlSJVL1XBmB44SK3YZXZ18k2P-b5AnMVo4gDWSgd-iYJWtOGkKBqeqOREHYKPMYAWUzCjDAdBsDg2KE4NitSgODYoWNK8fLBf-hHUP8XfyhKBnggxQW4PQdz6Jbh08n9cfwNnD6lu</recordid><startdate>20230301</startdate><enddate>20230301</enddate><creator>Wang, Cheng-long</creator><creator>Huan, Na</creator><creator>Wang, Pei-li</creator><creator>Geng, Qing-shan</creator><creator>Ma, Wen-lin</creator><creator>Ma, Li-hong</creator><creator>Jiang, Hong-yan</creator><creator>Meng, Xiao-ping</creator><creator>Zhang, Da-wu</creator><creator>Gou, Xiao-jiang</creator><creator>Hu, Da-yi</creator><creator>Chen, Ke-ji</creator><general>Springer Nature Singapore</general><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7X8</scope></search><sort><creationdate>20230301</creationdate><title>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</title><author>Wang, Cheng-long ; Huan, Na ; Wang, Pei-li ; Geng, Qing-shan ; Ma, Wen-lin ; Ma, Li-hong ; Jiang, Hong-yan ; Meng, Xiao-ping ; Zhang, Da-wu ; Gou, Xiao-jiang ; Hu, Da-yi ; Chen, Ke-ji</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c2593-2bf94cf398d0663fd2547389d8fc23b9bfb4f4ad6ace60d7d17bad433fc5eafd3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2023</creationdate><topic>Angina Pectoris - drug therapy</topic><topic>Anxiety</topic><topic>Coronary Disease - drug therapy</topic><topic>Depression</topic><topic>Double-Blind Method</topic><topic>Drugs, Chinese Herbal - therapeutic use</topic><topic>Humans</topic><topic>Medicine</topic><topic>Medicine & Public Health</topic><topic>Original Article</topic><topic>Percutaneous Coronary Intervention - adverse effects</topic><topic>Prognosis</topic><topic>Quality of Life</topic><topic>Treatment Outcome</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Wang, Cheng-long</creatorcontrib><creatorcontrib>Huan, Na</creatorcontrib><creatorcontrib>Wang, Pei-li</creatorcontrib><creatorcontrib>Geng, Qing-shan</creatorcontrib><creatorcontrib>Ma, Wen-lin</creatorcontrib><creatorcontrib>Ma, Li-hong</creatorcontrib><creatorcontrib>Jiang, Hong-yan</creatorcontrib><creatorcontrib>Meng, Xiao-ping</creatorcontrib><creatorcontrib>Zhang, Da-wu</creatorcontrib><creatorcontrib>Gou, Xiao-jiang</creatorcontrib><creatorcontrib>Hu, Da-yi</creatorcontrib><creatorcontrib>Chen, Ke-ji</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><jtitle>Chinese journal of integrative medicine</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Wang, Cheng-long</au><au>Huan, Na</au><au>Wang, Pei-li</au><au>Geng, Qing-shan</au><au>Ma, Wen-lin</au><au>Ma, Li-hong</au><au>Jiang, Hong-yan</au><au>Meng, Xiao-ping</au><au>Zhang, Da-wu</au><au>Gou, Xiao-jiang</au><au>Hu, Da-yi</au><au>Chen, Ke-ji</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>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</atitle><jtitle>Chinese journal of integrative medicine</jtitle><stitle>Chin. J. Integr. Med</stitle><addtitle>Chin J Integr Med</addtitle><date>2023-03-01</date><risdate>2023</risdate><volume>29</volume><issue>3</issue><spage>195</spage><epage>204</epage><pages>195-204</pages><issn>1672-0415</issn><eissn>1993-0402</eissn><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)</abstract><cop>Singapore</cop><pub>Springer Nature Singapore</pub><pmid>36301456</pmid><doi>10.1007/s11655-022-3688-3</doi><tpages>10</tpages></addata></record> |
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| identifier | ISSN: 1672-0415 |
| ispartof | Chinese journal of integrative medicine, 2023-03, Vol.29 (3), p.195-204 |
| issn | 1672-0415 1993-0402 |
| language | eng |
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| source | Springer Nature |
| subjects | Angina Pectoris - drug therapy Anxiety Coronary Disease - drug therapy Depression Double-Blind Method Drugs, Chinese Herbal - therapeutic use Humans Medicine Medicine & Public Health Original Article Percutaneous Coronary Intervention - adverse effects Prognosis Quality of Life Treatment Outcome |
| title | 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 |
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