Ming-Yue Sun1, Yang Miao2, Min Jin3, Yao-Rong Dong4, Shu-Rong Liu5, Mu-Lan Wang3, Rui Gao6. 1. Good Clinical Practice Center, Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing, 100091, China. 2. Department of Cardiology, Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing, 100091, China. 3. Chiatai Qingchunbao Pharmaceutical Co., Ltd., Hangzhou, 310023, China. 4. Department of Cardiology, Shanghai Municipal Hospital of Traditional Chinese Medicine Affiliated to Shanghai University of Traditional Chinese Medicine, Shanghai, 200071, China. 5. Department of Cardiology, The First Clinical Hospital of Jilin Academy of Chinese Medical Sciences, Changchun, 130021, China. 6. Good Clinical Practice Center, Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing, 100091, China. ruigao@126.com.
Abstract
OBJECTIVE: To investigate the effect and safety of Guanxinning Tablet (, GXN) for the treatment of stable angina pectoris patients with Xin (Heart)-blood stagnation syndrome (XBSS). METHODS:One hundred and sixty stable angina pectoris patients with XBSS were randomly assigned to receive GXN (80 cases) or placebo (80 cases, Guanxinning simulation tablets, mainly composed of lactose), 4 tablets (0.38 g/tablet), thrice daily for 12 weeks. After treatment, an exercise stress test (treadmill protocol), Chinese medicine (CM) syndrome score, electrocardiogram (ECG), and nitroglycerin withdrawal rate were evaluated and compared in the patients between the two groups. Meanwhile, adverse events (AEs) were evaluated during the whole clinical trial. RESULTS: Compared with the control group, the time extension of exercise duration in the GXN group increased 29.28 ±17.67 s after treatment (P>0.05); moreover, the change of exercise duration in the GXN group increased 63.10 ±96.96 s in subgroup analysis (P<0.05). The effective rates of angina pectoris, CM syndrome and ECG as well as nitroglycerin withdrawal rate were 81.33%, 90.67%, 45.76%, and 70.73%, respectively in the GXN group, which were all significantly higher than those in the control group (40.58%, 75.36%, 26.92%, 28.21%, respectively, P<0.05). CONCLUSION:GXN was a safe and effective treatment for stable angina pectoris patients with XBSS at a dose of 4 tablets, thrice daily.
RCT Entities:
OBJECTIVE: To investigate the effect and safety of Guanxinning Tablet (, GXN) for the treatment of stable angina pectorispatients with Xin (Heart)-blood stagnation syndrome (XBSS). METHODS: One hundred and sixty stable angina pectorispatients with XBSS were randomly assigned to receive GXN (80 cases) or placebo (80 cases, Guanxinning simulation tablets, mainly composed of lactose), 4 tablets (0.38 g/tablet), thrice daily for 12 weeks. After treatment, an exercise stress test (treadmill protocol), Chinese medicine (CM) syndrome score, electrocardiogram (ECG), and nitroglycerin withdrawal rate were evaluated and compared in the patients between the two groups. Meanwhile, adverse events (AEs) were evaluated during the whole clinical trial. RESULTS: Compared with the control group, the time extension of exercise duration in the GXN group increased 29.28 ±17.67 s after treatment (P>0.05); moreover, the change of exercise duration in the GXN group increased 63.10 ±96.96 s in subgroup analysis (P<0.05). The effective rates of angina pectoris, CM syndrome and ECG as well as nitroglycerin withdrawal rate were 81.33%, 90.67%, 45.76%, and 70.73%, respectively in the GXN group, which were all significantly higher than those in the control group (40.58%, 75.36%, 26.92%, 28.21%, respectively, P<0.05). CONCLUSION:GXN was a safe and effective treatment for stable angina pectorispatients with XBSS at a dose of 4 tablets, thrice daily.
Authors: Peter H Stone; Nikolay A Gratsiansky; Alexey Blokhin; I-Zu Huang; Lixin Meng Journal: J Am Coll Cardiol Date: 2006-06-15 Impact factor: 24.094
Authors: Michael McGillion; Heather M Arthur; Allison Cook; Sandra L Carroll; J Charles Victor; Philippe L L'allier; E Marc Jolicoeur; Nelson Svorkdal; Joel Niznick; Kevin Teoh; Tammy Cosman; Barry Sessle; Judy Watt-Watson; Alexander Clark; Paul Taenzer; Peter Coyte; Louise Malysh; Carol Galte; James Stone Journal: Can J Cardiol Date: 2012 Mar-Apr Impact factor: 5.223