Clinical Study Of Fufang Danshen Tablets On Treatment Of Vascular Dementia

Objectives1 To evaluate the validity and reliability of the Chinese version of Alzheimer's Disease Assessment Scale-cognitive subscale (ADAS-Cog) and Activity of Daily Living Scale (ADL).2 To observe Fufang Danshen Tablets on Mild-to-moderate Vascular Dementia (VaD) with obstruction of collaterals by blood stasis in patients with clinical efficacy.Methods1 According to the criteria of the NINDS-AIREN (the United States National Institute of Neurological Diseases and Stroke Neuroscience Research Institute and the International Association of Switzerland) and DSM-â…£(the United States, "Diagnostic and Statistical Manual of mental illness"), using the clock drawing test (CDT), Mini-Mental State Examination (MMSE) on patients to conduct an overall assessment.76 patients diagnosed as probable cases of Vascular Dementia, were studied. The raters were asked to score the ADAS-Cog, MMSE. Correlation analysis was applied for examining reliability and internal consistency.2 The study used randomized, parallel control method, according to the NINDS-AIREN and DSM-IV on the diagnosis of VaD Case selection criteria, using CDT, MMSE, Hamilton Depression Scale (HAMD) and HachinskiInchemic Score (HIS) on patients to conduct an overall assessment. After two weeks of eluting, a total of 48 patients were randomly assigned to recive a treatment of three tablets of Fufang Danshen Tablets three times per day (group F, n=24) or placebo three tablets of placebo three times per day (group P, n=24) for 24 weeks. Use life signs and laboratory checks, such as respiratory, blood pressure, heart rate, blood-routine, stool-routine, hepatorenal function, blood coagulation function and elctrocardiogram monitoring as safety index to make sure whether Fufang Danshen Tablets had any side-effects or toxicity. Before treatment, after 12 weeks and 24weeks of treatment efficacy in patients with TCM, ADAS-Cog, MMSE, ADL and the Purpose of Clinical Trials in Vascular Dementia Syndrome Scale (SDSVD) were assessed.Result1 For all items of ADAS-Cog and ADL, the values of Cronbach a for reliability were 0.947. The total score of the ADAS-Cog was positively correlated with that of ADL (r=0.720, P<0.01, respectively). And the total score of ADAS-Cog and ADL has the linear correlation (Y=0.696X+18.958). The scores of the items in the ADAS-Cog and ADL were correlated with each other significantly (r>0).2 The 48 patients completed clinical trials, according to the program, non-shedding and exclusion case. Fufang Danshen Tablets may improved in patients with the total score of MMSE,ADAS-Cog and ADL (P<0.01). The treatment group and the placebo group may improve the total score of SDSVD, but The treatment group was not superior to the placebo group (P>0.05). With respect to security, the treatment group and the placebo group were not found to exist on the human body side effect.Conclusion1 Both ADAS-Cog and ADL were useful as a clinical instrument to evaluate the severity of Vascular Dementia.2 Fufang Danshen Tablets may improve cognitive function and behavioral effects in patients with Mild-to-moderate VaD. Fufang Danshen Tablets had not shown that traditional Chinese medicine points significant improvement. Therefore, Fufang Danshen Tablets on the VaD with definite efficacy in improving symptoms.