Acute Efficacy of a Traditional Chinese Medicine for Treatment of Frequent Premature Ventricular Contractions in Patients with Concomitant Sinus Bradycardia: Results from a Double-Blind, Placebo-Controlled, Multicentre, Randomized Clinical Trial
Pharmacological antiarrhythmic therapy such as beta-blockers in patients with frequent premature ventricular contractions (PVCs) and concomitant bradycardia is challenging. A traditional Chinese medicine, Shensong Yangxin (SSYX), has been effective in treatment of frequent PVCs and sinus bradycardia...
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Language: | English |
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Hindawi Limited
2019-01-01
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Series: | Evidence-Based Complementary and Alternative Medicine |
Online Access: | http://dx.doi.org/10.1155/2019/3917282 |
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English |
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Article |
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DOAJ |
author |
Fengxiang Zhang Jiangang Zou Hao Yu Xiaorong Li Pipin Kojodjojo Xin Cai Shu Zhang Congxin Huang Kui Hong Bo Yu Guangping Li Suxin Luo Shenghua Zhou Yang Zheng Jie Fan Xuebin Cao Guizhou Tao Guotai Sheng Zhisheng Bai Shan Jiang Xiaolin Liu Weijuan Gu Feng Chen Kejiang Cao |
spellingShingle |
Fengxiang Zhang Jiangang Zou Hao Yu Xiaorong Li Pipin Kojodjojo Xin Cai Shu Zhang Congxin Huang Kui Hong Bo Yu Guangping Li Suxin Luo Shenghua Zhou Yang Zheng Jie Fan Xuebin Cao Guizhou Tao Guotai Sheng Zhisheng Bai Shan Jiang Xiaolin Liu Weijuan Gu Feng Chen Kejiang Cao Acute Efficacy of a Traditional Chinese Medicine for Treatment of Frequent Premature Ventricular Contractions in Patients with Concomitant Sinus Bradycardia: Results from a Double-Blind, Placebo-Controlled, Multicentre, Randomized Clinical Trial Evidence-Based Complementary and Alternative Medicine |
author_facet |
Fengxiang Zhang Jiangang Zou Hao Yu Xiaorong Li Pipin Kojodjojo Xin Cai Shu Zhang Congxin Huang Kui Hong Bo Yu Guangping Li Suxin Luo Shenghua Zhou Yang Zheng Jie Fan Xuebin Cao Guizhou Tao Guotai Sheng Zhisheng Bai Shan Jiang Xiaolin Liu Weijuan Gu Feng Chen Kejiang Cao |
author_sort |
Fengxiang Zhang |
title |
Acute Efficacy of a Traditional Chinese Medicine for Treatment of Frequent Premature Ventricular Contractions in Patients with Concomitant Sinus Bradycardia: Results from a Double-Blind, Placebo-Controlled, Multicentre, Randomized Clinical Trial |
title_short |
Acute Efficacy of a Traditional Chinese Medicine for Treatment of Frequent Premature Ventricular Contractions in Patients with Concomitant Sinus Bradycardia: Results from a Double-Blind, Placebo-Controlled, Multicentre, Randomized Clinical Trial |
title_full |
Acute Efficacy of a Traditional Chinese Medicine for Treatment of Frequent Premature Ventricular Contractions in Patients with Concomitant Sinus Bradycardia: Results from a Double-Blind, Placebo-Controlled, Multicentre, Randomized Clinical Trial |
title_fullStr |
Acute Efficacy of a Traditional Chinese Medicine for Treatment of Frequent Premature Ventricular Contractions in Patients with Concomitant Sinus Bradycardia: Results from a Double-Blind, Placebo-Controlled, Multicentre, Randomized Clinical Trial |
title_full_unstemmed |
Acute Efficacy of a Traditional Chinese Medicine for Treatment of Frequent Premature Ventricular Contractions in Patients with Concomitant Sinus Bradycardia: Results from a Double-Blind, Placebo-Controlled, Multicentre, Randomized Clinical Trial |
title_sort |
acute efficacy of a traditional chinese medicine for treatment of frequent premature ventricular contractions in patients with concomitant sinus bradycardia: results from a double-blind, placebo-controlled, multicentre, randomized clinical trial |
publisher |
Hindawi Limited |
series |
Evidence-Based Complementary and Alternative Medicine |
issn |
1741-427X 1741-4288 |
publishDate |
2019-01-01 |
description |
Pharmacological antiarrhythmic therapy such as beta-blockers in patients with frequent premature ventricular contractions (PVCs) and concomitant bradycardia is challenging. A traditional Chinese medicine, Shensong Yangxin (SSYX), has been effective in treatment of frequent PVCs and sinus bradycardia (SB) in separate patient cohorts. This double-blind, placebo-controlled, multicentre, randomized clinical trial investigates the acute efficacy of SSYX in reducing PVCs burden in patients with concomitant SB. Patients with symptomatic, frequent PVCs, and SB, defined as mean heart rate (MHR) of 45 to 59 beats per min (bpm), were recruited at 33 medical centres in mainland China and randomly assigned by computer to either SSYX or matching placebo for eight weeks. Patients, investigators, and trial personnel were masked to treatment allocation. Primary endpoints were changes in PVCs burden and MHR as assessed by 24-hour Holter monitoring relative to baseline. Secondary efficacy endpoints were subjective symptom score, ECG, and biochemical parameters. Analysis was based on intention-to-treat principles. 333 patients were randomized, of which 166 received SSYX and 167 placebo. Baseline characteristics did not differ. SSYX reduced PVCs burden by 68.2% (p < 0.001) and increased MHR by 10.9% (p < 0.001) compared to 32.2% and 4.7%, respectively, in the placebo group. SSYX group experienced greater symptomatic improvement (p < 0.001). No differences in reported adverse events were seen (20 versus 23). SSYX is an effective antiarrhythmic therapy for symptomatic, frequent PVCs uniquely suited patients with concomitant SB. Clinical trial number was NCT01750775. |
url |
http://dx.doi.org/10.1155/2019/3917282 |
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doaj-514774c1d1c64deaa7c1aea202cd9ae22020-11-24T22:02:23ZengHindawi LimitedEvidence-Based Complementary and Alternative Medicine1741-427X1741-42882019-01-01201910.1155/2019/39172823917282Acute Efficacy of a Traditional Chinese Medicine for Treatment of Frequent Premature Ventricular Contractions in Patients with Concomitant Sinus Bradycardia: Results from a Double-Blind, Placebo-Controlled, Multicentre, Randomized Clinical TrialFengxiang Zhang0Jiangang Zou1Hao Yu2Xiaorong Li3Pipin Kojodjojo4Xin Cai5Shu Zhang6Congxin Huang7Kui Hong8Bo Yu9Guangping Li10Suxin Luo11Shenghua Zhou12Yang Zheng13Jie Fan14Xuebin Cao15Guizhou Tao16Guotai Sheng17Zhisheng Bai18Shan Jiang19Xiaolin Liu20Weijuan Gu21Feng Chen22Kejiang Cao23Department of Cardiology, The First Affiliated Hospital of Nanjing Medical University, Nanjing, ChinaDepartment of Cardiology, The First Affiliated Hospital of Nanjing Medical University, Nanjing, ChinaDepartment of Statistics of Nanjing Medical University, Nanjing, ChinaDepartment of Cardiology, The First Affiliated Hospital of Nanjing Medical University, Nanjing, ChinaNational University Heart Centre, National University Hospital, SingaporeDepartment of Cardiology, The First Affiliated Hospital of Bengbu Medical College, Bengbu, ChinaDepartment of Cardiology, Chinese Academy of Medical Sciences Fuwai Cardiovascular Hospital, Beijing, ChinaDepartment of Cardiology, Renmin Hospital of Wuhan University, Wuhan, ChinaDepartment of Cardiology, The Second Affiliated Hospital of Nanchang University, Nanchang, ChinaDepartment of Cardiology, The First Affiliated Hospital of China Medical University, Shenyang, ChinaDepartment of Cardiology, The Second Hospital of Tianjin Medical University, Tianjin, ChinaDepartment of Cardiology, First Affiliated Hospital of Chongqing Medical University, Chongqing, ChinaDepartment of Cardiology, Xiangya No. 2 Hospital Central South University, Changsha, ChinaDepartment of Cardiology, No. 1 Hospital of Jilin University, Changchun, ChinaDepartment of Cardiology, First People's Hospital of Yunnan Province, Kunming, ChinaDepartment of Cardiology, The 252nd Hospital of Chinese People's Liberation Army, Beijing, ChinaDepartment of Cardiology, First Affiliated of Liaoning Medical University, Shenyang, ChinaDepartment of Cardiology, Jiangxi Provincial People's Hospital, Nanchang, ChinaDepartment of Cardiology, The Department of Cardiology, People's Hospital of Baoji City, Baoji, ChinaDepartment of Cardiology, Jinzhou Central Hospital, Jinzhou, ChinaDepartment of Cardiology, The First Affiliated Hospital of Nanjing Medical University, Nanjing, ChinaDepartment of Cardiology, The First Affiliated Hospital of Nanjing Medical University, Nanjing, ChinaDepartment of Statistics of Nanjing Medical University, Nanjing, ChinaDepartment of Cardiology, The First Affiliated Hospital of Nanjing Medical University, Nanjing, ChinaPharmacological antiarrhythmic therapy such as beta-blockers in patients with frequent premature ventricular contractions (PVCs) and concomitant bradycardia is challenging. A traditional Chinese medicine, Shensong Yangxin (SSYX), has been effective in treatment of frequent PVCs and sinus bradycardia (SB) in separate patient cohorts. This double-blind, placebo-controlled, multicentre, randomized clinical trial investigates the acute efficacy of SSYX in reducing PVCs burden in patients with concomitant SB. Patients with symptomatic, frequent PVCs, and SB, defined as mean heart rate (MHR) of 45 to 59 beats per min (bpm), were recruited at 33 medical centres in mainland China and randomly assigned by computer to either SSYX or matching placebo for eight weeks. Patients, investigators, and trial personnel were masked to treatment allocation. Primary endpoints were changes in PVCs burden and MHR as assessed by 24-hour Holter monitoring relative to baseline. Secondary efficacy endpoints were subjective symptom score, ECG, and biochemical parameters. Analysis was based on intention-to-treat principles. 333 patients were randomized, of which 166 received SSYX and 167 placebo. Baseline characteristics did not differ. SSYX reduced PVCs burden by 68.2% (p < 0.001) and increased MHR by 10.9% (p < 0.001) compared to 32.2% and 4.7%, respectively, in the placebo group. SSYX group experienced greater symptomatic improvement (p < 0.001). No differences in reported adverse events were seen (20 versus 23). SSYX is an effective antiarrhythmic therapy for symptomatic, frequent PVCs uniquely suited patients with concomitant SB. Clinical trial number was NCT01750775.http://dx.doi.org/10.1155/2019/3917282 |