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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...
Autores principales: | , , , , , , , , , , , , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Hindawi
2019
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6425419/ https://www.ncbi.nlm.nih.gov/pubmed/30949218 http://dx.doi.org/10.1155/2019/3917282 |
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author | Zhang, Fengxiang Zou, Jiangang Yu, Hao Li, Xiaorong Kojodjojo, Pipin Cai, Xin Zhang, Shu Huang, Congxin Hong, Kui Yu, Bo Li, Guangping Luo, Suxin Zhou, Shenghua Zheng, Yang Fan, Jie Cao, Xuebin Tao, Guizhou Sheng, Guotai Bai, Zhisheng Jiang, Shan Liu, Xiaolin Gu, Weijuan Chen, Feng Cao, Kejiang |
author_facet | Zhang, Fengxiang Zou, Jiangang Yu, Hao Li, Xiaorong Kojodjojo, Pipin Cai, Xin Zhang, Shu Huang, Congxin Hong, Kui Yu, Bo Li, Guangping Luo, Suxin Zhou, Shenghua Zheng, Yang Fan, Jie Cao, Xuebin Tao, Guizhou Sheng, Guotai Bai, Zhisheng Jiang, Shan Liu, Xiaolin Gu, Weijuan Chen, Feng Cao, Kejiang |
author_sort | Zhang, Fengxiang |
collection | PubMed |
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. |
format | Online Article Text |
id | pubmed-6425419 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2019 |
publisher | Hindawi |
record_format | MEDLINE/PubMed |
spelling | pubmed-64254192019-04-04 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 Zhang, Fengxiang Zou, Jiangang Yu, Hao Li, Xiaorong Kojodjojo, Pipin Cai, Xin Zhang, Shu Huang, Congxin Hong, Kui Yu, Bo Li, Guangping Luo, Suxin Zhou, Shenghua Zheng, Yang Fan, Jie Cao, Xuebin Tao, Guizhou Sheng, Guotai Bai, Zhisheng Jiang, Shan Liu, Xiaolin Gu, Weijuan Chen, Feng Cao, Kejiang Evid Based Complement Alternat Med Research Article 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. Hindawi 2019-03-04 /pmc/articles/PMC6425419/ /pubmed/30949218 http://dx.doi.org/10.1155/2019/3917282 Text en Copyright © 2019 Fengxiang Zhang et al. https://creativecommons.org/licenses/by/4.0/ This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. |
spellingShingle | Research Article Zhang, Fengxiang Zou, Jiangang Yu, Hao Li, Xiaorong Kojodjojo, Pipin Cai, Xin Zhang, Shu Huang, Congxin Hong, Kui Yu, Bo Li, Guangping Luo, Suxin Zhou, Shenghua Zheng, Yang Fan, Jie Cao, Xuebin Tao, Guizhou Sheng, Guotai Bai, Zhisheng Jiang, Shan Liu, Xiaolin Gu, Weijuan Chen, Feng Cao, Kejiang 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 | 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_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_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 |
topic | Research Article |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6425419/ https://www.ncbi.nlm.nih.gov/pubmed/30949218 http://dx.doi.org/10.1155/2019/3917282 |
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