Combination of Chinese Herbal Medicines and Conventional Treatment versus Conventional Treatment Alone on Acute Coronary Syndrome after Percutaneous Coronary Intervention:An Open-label Randomized Controlled Study
Background:Previous studies of Chinese herbal medicines plus conventional treatment showed some beneficial effects in the treatment of coronary artery disease.Howver,it remains unclear if this treatment method improved clincial outcome as evaluated with cardiovascular events in acuete coronary syndrome after percutaneous coronary intervention. Objective:To evaluate efficacy and safety of Chinese herbal medicines plus conventional treatment on acute coronary syndrome after percutaneous coronary intervention.Design:Prospective,open-label,randomized,controlled trial (chictr.org number:ChiCTR-TRC-00000021).Setting:13 hospitals from 5 provinces in mainland China.Patients:808 adults with acute coronary syndrome after percutaneous coronary intervention.Intervention:Chinese herbal medicines plus conventional treatment (treatment group) or conventional treatment alone (control group).All participants received conventional treatment,but participants in treatment group additionally received Chinese herbal medicines (Xinyue Capsule and Fufang Chuanxiong Capsule),2 capsules orally,3 times daily for 6 months.Measurements:The primary end point was the composite of cardiac death,nonfatal recurrent myocardial infarction or repeat revascularization.The secondary end point was the composite of readmission for acute coronary syndrome,stroke,or congestive heart failure.The safety end point was major bleeding events.Results:The incidence of the primary end point was 2.7% in the treatment group versus 6.2% in the control group (HR,0.43;95%CI,0.21 to 0.87;P=0.015).The incidence of secondary end point was 3.5% in the treatment group versus 8.7% in the control group (HR,0.39;95%CI,0.21 to 0.72;P=0.002).No major bleeding events were found in any participant.Limitations:A double-blind procedure was not used.Conclusions:Treatment with Chinese herbal medicines in combination with conventional treatment further reduced the cardiovascular events in patients with acute coronary syndrome after percutaneous coronary intervention without increased risk of major bleeding.
Da-Zhuo Shi Chang-geng Fu Shu-Zheng Lü Shi-Jie You Jun-Bo Ge Tian-Chang Li Xian Wang Guan-Lin Yang Hong-Xu Liu Jing-Yuan Mao Rui-Jie Li Cheng-Long Wang Li-Dian Chen Chu Lu Shao-Li Wang Ke-Ji Pei-Li Wang Hao Xu Hong-Ying Liu Jian-Peng Du Da-Wu Zhang Zhu-Ye Gao Lei Zhang
the Second People”s Hospital of Fujian Province,Fuzhou350003 Xiyuan Hospital,China Academy of Chinese Medical Sciences,Beijing 100091 Beijing Anzhen Hospital,Beijing Institute of Respiratory Medicine,Capital Medical University,Beijing Cardiovascular Institute & Fuwai Hospital,Chinese Academy of Medical Sciences & Peking Union Medical Zhongshan Hospital,Fudan University,Shanghai 200032 Beijing Tongren Hospital,Capital Medical University,Beijing 100730 Dongzhimen Hospital Affiliated to Beijing University of Chinese Medicine,Beijing 100700 The Affiliated Hospital of Liaoning Traditional Chinese Medicine University,Shenyang 110032 Beijing Chinese Medicine Hospital,Capital Medical University,Beijing 100010 First Teaching Hospital of Tianjin University of Traditional Chinese Medicine,Tianjin 300193 Beijing Chuiyangliu Hospital,Beijing 100022 Wuxi Traditional Chinese Medicine Hospital,Nanjing University of Traditional Chinese Medicine,Wuxi 2