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.

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.