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Journal of Chinese Integrative Medicine ›› 2012, Vol. 10 ›› Issue (11): 1240-1246.doi: 10.3736/jcim20121107

• Original Clinical Research • Previous Articles     Next Articles

Effects of Chinese medicine for promoting blood circulation and removing blood stasis in treating patients with mild to moderate vascular dementia: a randomized, double-blind and parallel-controlled trial

Ming-qing Wei1, Jin-zhou Tian1(), Jing Shi1, Fu-yun Ma1, Ying-chun Miao1, Yong-yan Wang2   

  1. 1. Department of Encephalopathy, Dongzhimen Hospital, Beijing University of Chinese Medicine, Beijing 100700, China
    2. Institute of Basic Research for Clinical Medicine, China Academy of Chinese Medical Sciences, Beijing 100700, China
  • Received:2012-04-25 Accepted:2012-07-02 Online:2012-11-20 Published:2018-11-15

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Background: Vascular dementia (VaD) is the second common subtype of dementia after Alzheimer’s disease. However, there is still a lack of medication that demonstrates clinically relevant symptomatic improvement. Static blood obstructing the brain is the main Chinese medicine syndrome of VaD.

Objective: To evaluate the effects of Chinese medicine for promoting blood circulation and removing blood stasis in patients with mild to moderate VaD.

Design, setting, participants and interventions: In this 12-week randomized, double-blind, parallel-controlled trial, a total of 48 patients with mild to moderate VaD were enrolled between March 2009 and December 2010. All the patients entered a two-week placebo run-in period followed by a 12-week treatment with Chinese medicine for promoting blood circulation and removing blood stasis (n=24) or placebo (n=24), respectively. The placebo tablets have the identical taste and appearance as the Chinese medicine tablets.

Main outcome measures: The primary outcome measure was the Alzheimer’s Disease Assessment Scale-cognitive subscale (ADAS-cog); the secondary outcome measures included the Activities of Daily Living (ADL) and the Mini-Mental State Examination (MMSE).


Results: The Chinese medicine group showed a slight deterioration of 0.25 points and the placebo group showed a deterioration of 2.35 points from baseline by the ADAS-cog, and there was a significant difference between the two groups (P=0.027). The ADL and the MMSE showed no significant difference from baseline in both groups. Adverse events were rare in both groups.

Conclusion: The Chinese medicine for promoting blood circulation and removing blood stasis may improve cognition and it is safe and well tolerated.

Key words: dementia,vascular, drugs,Chinese herbal, blood-activating stasis-removing agents, randomized controlled trial

Figure 1

Flow diagram of the study population"

"

Index Placebo (n=23) Chinese medicine (n=24) P value
Age (year) 62.5±8.5 66.9±7.0 0.088
Gender (male/female) 16/8 16/8 1.00
Education (year) 8.6±1.0 8.1±1.4 0.160
Race (Han/others) 22/2 23/1 0.50
Height (cm) 167.5±8.3 165.1±6.5 0.282
Weight (kg) 66.3±11.6 66.7±10.7 0.868
HIS score 11.08±2.19 11.13±1.83 0.975
MMSE score 22.96±2.71 22.92±2.24 0.766
HAMD score 4.79±4.23 4.96±4.34 0.983
ADAS-cog score 12.50±8.30 11.53±2.88 0.252
ADL score 20.67±9.26 19.40±6.87 0.502
SDSVD score 12.67±4.66 13.08±3.16 0.324

"

Group n ADAS-cog ADL MMSE
Placebo 23 2.35±4.79 0.26±2.90 0.58±0.02
Chinese medicine 24 0.25±3.80* 1.04±3.51 0.38±1.50

Figure 2

ADAS-cog score at baseline and follow-up ADAS-cog: Alzheimer’s Disease Assessment Scale-cognitive subscale."

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