The effects of Deng Zhan Sheng Mai capsule on secondary and tertiary prevention of ischemic stroke

Objective To evaluate the effects of Deng Zhan Sheng Mai (DZSM) capsule, a compound made of Chinese herbs, on secondary and tertiary prevention of ischemic stroke. Methods A hospital-based randomized open-blinded clinical trial was conducted among people with a prior history of ischemic stroke. Hospitals were assigned to treatment group, in which all of the participants took DZSM capsules for 3 months, or control group, in which no DZSM capsules was administrated. The primary endpoint was the reduction of levels of blood lipids, fasting blood glucose (FBG) and fibrinogen in the 3rd month. The secondary endpoints were recurrence of stroke, incidence of cardiovascular event (CVD) and all-cause mortality in the 18th month. Results 495 people were enrolled in the treatment group and 504 in the control group, respectively. In the 3rd month, the levels of total cholesterol(TC),FBG and fibrinogen were significantly reduced by 1.7%,4.3 and 8.2%(t values were 4.13,6.65 and 8.50 respectively),and the levels of HDL-C and HDL-C/TC were increased by 7.6%and 1 1.6%(t values were 2.15 and 3.67)in the treatment group, respectively(all P＜0.05＝.The levels of TC,HDL-C and HDL-C/TC decreased significantly in the eontrol group(all P＜0.05＝.The incidence of recurrent stroke and CVD events were lower in the treatment group than those in the control group, but the differences did not reach the significant levels. The prevalence of post-stroke depression (PSD) was also decreased in the 3rd mouth while it remained stable in the controls (P for trend equals to 0.0027). The mortality was significantly lower in the treatment group (P=0.008). Conclusion The levels of TC,FBG and fibrinogen as well as the prevalence of PSD and all-cause mortality have decreased significantly in treatment group treated with DZSM capsule for 3 months as compared with the control group. Key words: Brain ischemia;  Cerebrovascular accident;  Erigeron breviscapua;  Randomized controlled trials