| Objective:Re-evaluating the effectiveness of Yi-Zhi-An-Shen(YZAS)formula on kidney deficiency,phlegm and blood stasis syndrome of amnestic mild cognitive impairment(aMCI),through the clinical trial of on its effects on global cognitive function and sleep quality of individuals with kidney deficiency,phlegm and blood stasis syndrome of aMCI.Methods:According to the principle of randomized,double-blinded,placebo-controlled trial,77 patients with kidney deficiency,phlegm and blood stasis syndrome of aMCI were included.38 subjects were randomly assigned to YZAS group,while 39 to placebo group randomly.Besides the basic treatment,the YZAS group was administered YZAS formula,1 grid each time mixed with boiled water 50ml,3 times a day for 16 weeks.While the placebo group took placebo,with the same taking method,dose,course of intervention as YZAS group.According to the protocol,the Alzheimer’s disease assessment scale-cognitive subscale(ADAS-cog)of all the subjects were assessed before the intervention and after 16 weeks of intervention for twice.The mini-mental state examination(MMSE),Montreal cognitive assessment(MoCA),clinical dementia rating-sum of boxes(CDR-SB),Pittsburgh sleep quality index(PSQI),and pattern element scale for dementia(PES-D)were assessed before the intervention,after 8 weeks and 16 weeks of intervention for three times.The efficacy of YZAS formula was evaluated by the changes of scores from baseline.Any adverse reactions were recorded in time to assess the safety of YZAS formula.Results:(1)After 16 weeks of invention,the ADAS-cog scores of the YZAS group and the placebo group were statistically different(P<0.001).The two groups before and after the control showed that the ADAS-cog score in the YZAS group was significantly lower(P<0.001),and the score in the placebo group was increased(P<0.001).(2)The P values of observation points of MMSE and MoCA in the two groups were all less than 0.001,and the MMSE and MoCA scores at each time point were significantly different.The MMSE and MoCA scores between the YZAS group and the placebo group were not statistically different at 8th week(P=0.188,P=0.054),and there were statistical differences at16th week(P<0.001).(3)The P value at the observation times of CDR-SB in the two groups was 0.02.There were no significant differences in CDR-SB scores between the YZAS and placebo subjects at8th week(P=0.266)and 16th week(P=0.051).(4)The PSQI scores of the two groups were both lower than the baseline values,and the P value at the observation times was less than 0.001.The PSQI scores between the two groups showed statistical differences at the end of the 16th week(P=0.012).(5)In the two groups of subjects,the P values of kidney deficiency,phlegm,and blood stasis syndrome were less than 0.001,indicating that the kidney group,phlegm,and blood stasis syndrome scores in the placebo group were similar over the whole trial period,while the kidney deficiency,turbidity,and blood stasis scores of the YZAS group decreased significantly at three time observation points respectively.Kidney deficiency(P=0.002),phlegm(P<0.001),and blood stasis syndrome scores(P<0.001)in the YZAS group improved more significantly at the 16th week compared with the placebo group,and phlegm(P=0.048),blood stasis(P=0.016)improved more significantly at the 8th weekend than the placebo group.(6)After 16 weeks of intervention,the scatter plots of the ADAS-cog and the PSQI of the YZAS group showed a linear relationship.Correlation analysis indicated that r_s was 0.467.(7)In this trial,2 adverse events in total occurred in 38 subjects in the YZAS group,with an incidence of 5.3%.Conclusion:Compared with placebo,YZAS formula can significantly improve the global cognitive function,sleep quality(self-evaluation)and clinical symptoms of patients with kidney deficiency,phlegm and blood stasis syndrome of aMCI with good safety.Moreover,its improvement on the global cognitive function of individuals with kidney deficiency,phlegm and blood stasis syndrome of aMCI may be correlated with the improvement of sleep quality. |
PDF Full Text Request