Objective: To explore the clinical effect and possible mechanism of modified Shuyuwan in treatment of mild and moderate Alzheimer's disease(AD). Method: Totally 96 patients with mild and moderate AD were randomly divided into treatment group and control group

with 48 patients in each group. Patients in the treatment group took modified Shuyuwan

15 mL each time

twice a day

while those in control group took Donepezil tablet

5 mg/time before bedtime. The treatment course was 12 weeks in both groups. The Mini-mental State Examination (MMSE) scale

Activity of Daily Living (ADL) scale as well as Pattern and Element of Syndrome of Alzheimer's disease (AD-PES-11) Scale were evaluated before and after treatment. Another 48 cases with normal cognitive function were collected as normal group. The serum microRNA-132 (miR-132)

miR-34a

miR-9

and let-7i levels of the 3 groups were measured by Real-time PCR both before and after treatment. Spearman correlation coefficient analysis was used to analyze the correlation between the score of neuropsychological test scales

AD-PES-11 scale and miRNAs levels. Result: As compared with those before treatment

the scores of MMSE were increased significantly after treatment

while the scores of ADL were decreased significantly in both groups (P<0.01). As compared with those before treatment

the scores of AD-PES-11 scale

kidney deficiency

spleen deficiency

medullary decrease

phlegm turbidity and blood stasis were significantly decreased after treatment in treatment group (P<0.05

P<0.01)

while in control group

the score of spleen deficiency was increased significantly (P<0.05). As compared with control group

the scores of AD-PES-11 scale

kidney deficiency

spleen deficiency

phlegm and blood stasis were decreased significantly in treatment group after treatment (P<0.01). As compared with normal group

the expression levels of serum miR-132

miR-34a

and let-7i were significantly increased in treatment and control groups before treatment

and the expression of miR-9 was significantly decreased (P<0.01). As compared with those before treatment

the expression levels of serum miR-132

miR-34a

and let-7i were significantly decreased after treatment in the 2 groups

and the expression of miR-9 was significantly increased (P<0.05

P<0.01). Correlation analysis showed that miR-34a expression level was positively correlated with kidney deficiency

phlegm turbidity and total scores (P<0.01); miR-9 expression level was negatively correlated with phlegm turbidity and total scores (P<0.05

P<0.01). Conclusion: Modified Shuyuwan can effectively improve the cognitive function and daily life ability of AD patients

improve the status of kidney deficiency

spleen deficiency

medullary decrease

phlegm turbidity and blood stasis

and its mechanism may be related to regulating the levels of serum miR-132

miR-34a

miR-9 and let-7i.