Traditional Chinese medicine, Danlou tablets alleviate adverse left ventricular remodeling after myocardial infarction: results of a double-blind, randomized, placebo-controlled, pilot study.
BACKGROUND
Danlou tablets, a patented Chinese Medicine, have been long approved for the treatment of ischemic heart disease in China. While numerous empirical observations suggested Danlou tablets could decrease frequency and duration of angina pectoris attacks, evidence supporting its efficacy on cardiac remodeling remains inadequate. Therefore, this pilot trial was designed to determine whether Danlou tablets would reduce adverse left ventricular (LV) remodeling in patients with myocardial infarction (MI).


RESULTS
Eligible patients with acute MI were enrolled and randomly assigned to Danlou tablets or placebo groups, superimposed on standard treatment for MI. Then, in addition to assessment of the clinical outcome, the changes in LV volumes were evaluated by a serial echocardiography. In total, 83 patients (Danlou tablets 42 and placebo 41) completed 90 days of treatment and had complete baseline and outcome data. Standard echocardiographic evaluations revealed significant differences in the change of LV end-diastolic volume index (LVEDVi) between group of patients treated with Danlou tablets and the placebo group (-4.49 ± 7.29 vs. -0.34 ± 9.01 mL/m2, P < 0.001). The reduction in LVEDVi was independent of beta-blocker, ACE inhibitors/ARBs use. Furthermore, treatment with Danlou tablets significantly reduced LV end-systolic volume index (-4.09 ± 5.85 vs. -0.54 ± 5.72 mL/m2, P < 0.001) and improved the LV ejection fraction (4.83 ± 9.23 vs. 0.23 ± 8.15 %, P < 0.001), as compared to placebo. Meaningfully, the incidence of the major adverse cardiovascular events was also lower in patients receiving Danlou tablets (P < 0.05).


CONCLUSIONS
Superimposed on the standard pharmacologic treatment, Danlou tablets significantly reversed post-MI adverse LV remodeling, thereby contributed to the overall positive clinical outcome.


BACKGROUND
clinicaltrials.gov identifier NCT02675322 (February 1, 2016).
Second Clinical Medical College, Key Discipline of Integrated Traditional Chinese and Western Medicine, Guangzhou University of Chinese Medicine, Guangzhou, 510405, China.|Department of Critical Care Medicine, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou, 510120, China.|Physiology & Experimental Medicine Program, Hospital for Sick Children, Toronto, M5G1X8, Canada.
Shuai
S
Mao
Second Clinical Medical College, Key Discipline of Integrated Traditional Chinese and Western Medicine, Guangzhou University of Chinese Medicine, Guangzhou, 510405, China.|Department of Critical Care Medicine, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou, 510120, China.
Lei
L
Wang
Second Clinical Medical College, Key Discipline of Integrated Traditional Chinese and Western Medicine, Guangzhou University of Chinese Medicine, Guangzhou, 510405, China.|Department of Public Health Sciences, Health Systems and Policy, Karolinska Institutet, Stockholm, 17177, Sweden.
Wenwei
W
Ouyang
Department of Critical Care Medicine, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou, 510120, China.
Yuanshen
Y
Zhou
Department of Critical Care Medicine, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou, 510120, China.
Jianyong
J
Qi
Department of Critical Care Medicine, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou, 510120, China.
Liheng
L
Guo
Second Clinical Medical College, Key Discipline of Integrated Traditional Chinese and Western Medicine, Guangzhou University of Chinese Medicine, Guangzhou, 510405, China. minzhouzhang@yeah.net.|Department of Critical Care Medicine, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou, 510120, China. minzhouzhang@yeah.net.
Minzhou
M
Zhang
Physiology & Experimental Medicine Program, Hospital for Sick Children, Toronto, M5G1X8, Canada.
Aleksander
A
Hinek
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D002681:China; D004311:Double-Blind Method; D004365:Drugs, Chinese Herbal / Q000008:administration & dosage*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000150:complications*; D010865:Pilot Projects; D011446:Prospective Studies; D018487:Ventricular Dysfunction, Left / Q000188:drug therapy* / Q000209:etiology / Q000503:physiopathology; D020257:Ventricular Remodeling / Q000187:drug effects; D055815:Young Adult
D004365:Drugs, Chinese Herbal
Danlou tablets; Left ventricular end-diastolic volume index; Myocardial infarction; Ventricular remodeling