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Effect evaluation in randomized controlled trials for vascular cognitive impairment taking Duxil as known effective medicine
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DOI   10.11656/j.issn.1672-1519.2013.12.04
Key Words   Duxil;vascular cognitive impairment;effect value of vascular dementia
Author NameAffiliationE-mail
LI Zhen-yu The Second Clinical College of Guangzhou University of TCM, Guangzhou 510120, China  
LIU Shao-nan The Academy of TCM of Guangdong Province, Guangzhou 510120, China  
YANG Li-hong The Academy of TCM of Guangdong Province, Guangzhou 510120, China  
LI Xiao-yan The Academy of TCM of Guangdong Province, Guangzhou 510120, China  
NI Xiao-jia The Academy of TCM of Guangdong Province, Guangzhou 510120, China  
GUO Xin-feng The Academy of TCM of Guangdong Province, Guangzhou 510120, China guoxinfeng@139.com 
WEN Ze-huai The Academy of TCM of Guangdong Province, Guangzhou 510120, China
National DME Training Centre, Guangzhou University of TCM, Guangzhou 510405, China 
 
Abstract
    [Objective] New evidence has showed that Duxil is not effective for treating vascular cognitive impairment (VCI), so it is necessary to re-evaluate the clinical effectiveness of clinical trials using Duxil as the positive control. This study aims to re-evaluate the efficacy of therapies for VCI in randomized Duxil controlled trials. [Methods] Chinese and English electronic databases were searched for randomized Duxil controlled trials for VCI till August, 2012. The evaluating tool of risk in bias assessment of Cochrane Handbook 5.0 was used for quality assessment. Two investigators extracted the data and assessed its quality independently. EpiCalc 2000 and SPSS18.0 were used for calculating the effect size (Cohen's d). The cutpoint between superiority and equivalence trial was set as less than 0.2, and 0.2~0.3 was taken as the margin interval. [Results] In total, 19 trials for vascular dementia were enrolled (two 3-armed trials, including 21 interventions). Among them, six interventions had a effect size (Cohen'D) not less than 0.3 or equal to 0.3. The 7 effect values lied in the margin interval between 0.2 to 0.3, 5 effect values less than 0.2, and the efficacy of the other 3 control groups were superior than treatment group. [Conclusion] In 21 experiments performance comparisons of 19 trials, 6 interventions are superior than Duxil control group, while 8 experiments performance are in need for further discussed. High quality placebo-controlled clinical studies on treatments of VCI are needed. For the 7 effect values lied in the margin interval between 0.2~0.3, their clinical effectiveness also needs further discussing.

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