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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

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."

[1] Dubois MF, Hebert R . The incidence of vascular dementia in Canada: a comparison with Europe and East Asia. Neuroepidemiology. 2001; 20(3):179-187.
doi: 10.1159/000054785 pmid: 11490164
[2] Lobo A, Launer LJ, Fratiglioni L, Andersen K, Di Carlo A, Breteler MM, Copeland JR, Dartigues JF, Jagger C, Martinez-Lage J, Soininen H, Hofman A . Prevalence of dementia and major subtypes in Europe: A collaborative study of population-based cohorts. Neurologic Diseases in the Elderly Research Group. Neurology. 2000; 54(11 Suppl 5) : S4-S9.
[3] Dong MJ, Peng B, Lin XT, Zhao J, Zhou YR, Wang RH . The prevalence of dementia in the People’s Republic of China: a systematic analysis of 1980-2004 studies. Age Ageing. 2007; 36(6):619-624.
doi: 10.1093/ageing/afm128
[4] Broich K . Outcome measures in clinical trials on medicinal products for the treatment of dementia: a European regulatory perspective. Int Psychogeriatr. 2007 ; 19(3) : 509-524.
doi: 10.1017/S1041610207005273
[5] Tian J, Shi J, Zhang X, Wang Y . Herbal therapy: a new pathway for the treatment of Alzheimer 5 s disease . Alzheimers Res Ther. 2010; 2(5) : 30.
doi: 10.1186/alzrt54 pmid: 21067555
[6] Shi J, Wei MQ, Ma FY, Mao YC, Tian JZ. Characteristic of syndrome of Chinese medicine in vascular cognitive impairment patients. Zhong Yi Za Zhi. 2012 ; 53(6):503-506. Chinese with abstract in English.
时晶, 魏明清, 马福云, 苗迎春, 田金洲 . 血管性认知损害的中医证候特征.中医杂志. 2012; 53(6):503-506.
[7] Guo ZS. Effects of Chinese medicine for promoting blood circulation and removing blood stasis in treating patients with vascular dementia. Yi Yao Lun Tan Za Zhi. 2009; 30(22):99-100. Chinese.
郭志生 . 活血化瘀法治疗血管性痴呆疗效观察.医药论坛杂志. 2009; 30(22):99-100.
[8] He Z, Pan ZH , Lu WH. Neuroprotective effects of tanshinone II A on vascular dementia in rats. Zhongguo Zhong Yao Za Zhi. 2010; 35(14): 883-886. Chinese with abstract in English.
何治, 潘志红, 鲁文红 .丹参酮nA对血管性痴呆大鼠的神经保护作用机制 .中国中药杂志. 2010; 35(14): 883 _886 .
[9] Guo CJ, Wu JX , Li RX. Effects of Panax notoginseng saponins on the concentrations of neurotransmitters in brain of Alzheimer 5 s disease model mouse. Zhongguo Lin Chuang Yao Xue Za Zhi. 2004; 13(3): 150-152. Chinese with abstract in English.
郭长杰, 伍杰雄, 李若馨 . 三七总皂苷对痴呆模型大鼠大脑皮质内神经递质含量的影响.中国临床药学杂志. 2004; 13(3) : 150-152.
[10] American Psychiatric Association . Diagnostic and Statistical Manual of Mental Disorders. 4th ed, text revised. Washington DC: American Psychiatric Association. 2000.
doi: 10.1016/S0033-3182(88)72438-X
[11] Roman GC, Tatemichi TK, Erkinjuntti T, Cummings JL, Masdeu JC, Garcia JH, Amaducci L, Orgogozo JM, Brun A, Hofman A, Moody DM , O’Brien MD, Yamaguchi T, Graf man J, Drayer BP, Bennett DA, Fisher M, Ogata J, Kokmen E, Bermejo F, Wolf PA, Gorelick PB, Bick KL, Pajeau AK, Bell MA, DeCarli C, Culebras A, Korczyn AD, Bogousslavsky J, Hartmann A, Scheinberg P. Vascular dementia: diagnostic criteria for research studies. Report of the NINDS^ AIREN International Workshop. Neurology. 1993; 43(2):250-260.
[12] Rosen WG, Terry RD, Fuld PA, Katzman R, Peck A . Pathological verification of ischemic score in differentiation of dementias. Ann Neurol. 1980 ; 7(5):486-488.
doi: 10.1002/(ISSN)1531-8249
[13] Folstein MF, Folstein SE, McHugh PR. “Mini-mental state". A practical method for grading the cognitive state of patients for the clinician. [J] Psychiatr Res. 1975; 12(3):189-198.
doi: 10.1016/0022-3956(75)90026-6
[14] Hamilton M . A rating scale for depression.[J] Neurol Neurosurg Psychiatry. 1960; 23:56-62.
doi: 10.1136/jnnp.23.1.56
[15] Tian JZ, Han MX, Tu JW, Yang CZ, Yang HM, Zou YH, Liu H. The diagnositic criteria,syndromes differentiation and outcome measures for vascular dementia. Beijing Zhong Yi Yao Da Xue Xue Bao. 2000; 23(5): 18-23. Chinese.
doi: 10.3321/j.issn:1006-2157.2000.05.007
田金洲, 韩明向, 涂晋文, 杨承芝, 杨惠民, 邹忆怀, 刘恒 . 血管性痴呆的诊断、辨证及疗效判定标准.北京中医药大学学报. 2000; 23(5):18-23.
doi: 10.3321/j.issn:1006-2157.2000.05.007
[16] Rosen WG, Mohs RC, Davis KL . A new rating scale for Alzheimer 5 s disease. Am [J] Psychiatry. 1984 ; 141(11):1356-1364.
[17] Lawton MP, Brody EM . Assessment of older people: self-maintaining and instrumental activities of daily living. Gerontologist. 1969; 9(3):179-186.
doi: 10.1093/geront/9.3_Part_1.179 pmid: 5349366
[18] Tian JZ, Liu H. Research method of the senile dementia in Chinese medicine. Zhongguo Yi Yao Xue Bao. 2000; 15(5) : 52-54. Chinese.
田金洲, 刘姮 . 老年期痴呆的中医药研究思路.中国医药学报. 2000; 15(5) : 52-54.
[19] Jiang P, Chen M, Lii J, Chen C, Jiao BH. Effect of tanshinone II A on MMP-2 and iNOS expression and free radical release in hippocampus of rat Alzheimer 5 s disease mode. Di Er Jun Yi Da Xue Xue Bao. 2010; 31(4):380-384. Chinese with abstract in English.
蒋平, 陈鸣, 吕军, 陈卿, 焦炳华 . 丹参酮Ⅱ A对阿尔茨海默病模型大鼠海马MMP-2、iNOS表达及自由基释放的影响.第二军医大学学报. 2010; 31(4):380-384.
[20] Zhu YL, Yang WQ. Effects of Compound Tablet of Red Sage Root on the expression of VEGF in brain of rat during chronic cerebral ischemia. Zhongguo Shi Yong Shen Jing Ji Bing Za Zhi. 2007 ; 10(6):26-27. Chinese with abstract in English.
朱永林, 杨伟琴 . 复方丹参片对慢性脑缺血大鼠脑内 VEGF表达的影响.中国实用神经疾病杂志. 2007; 10(6):26-27.
[21] Ferris SH . Cognitive outcome measures. Alzheimer Dis Assoc Disord. 1999; 13(suppl 3) : S140-S142.
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