Efficacy Of Phlegm-resolving Orifice-Opening Decoction For Alzheimer's Disease Patients With Phlegm-turbidity Obstructing Orifices Pattern

Objective:The study aimed to explore the addictive effect and safety of Phlegm-resolving Orifice-Opening Decoction on donepezil for Alzheimer's Disease(AD)patients with Phlegm-turbidity Obstructing Orifices Pattern.Methods:Diagnosis of AD referred to 2011 NINCDS-ADRDA's diagnostic criteria of AD.Diagnosis of Phlegm-turbidity Obstructing Orifices Pattern of Senile dementia referred to the 2002 Chinese medicine new medicine clinical research guiding principles(pilot test).65 case of Mild-to-moderate AD patients from outpatient and ward of our hosipital,in line with Western medicine diagnostic criteria and Chinese medicine diagnostic criteria,were enrolled and randomized to integrative group and western medicine group.The integrative group was treated by Phlegm-resolving Orifice-Opening Decoction combined with Donepezil.The western medicine group was treated by Donepezil alone.Both groups take medication consecutively for 6 months.MMSE,ADAS-cog,ADL and the TCM syndrome scores were assessed and compared between the two groups at baseline and after the treatment.At the same time,adverse reactions were recorded,and compared with results of routine blood,urine routines,heart,liver,kidney function and electrocardiogram(ECG)as a safety evaluation indexes,finally statistical analysis of differences in the two groups of patients.Results:1.A total of 65 cases of mild-to-moderate AD were enrolled,with 60 cases completing the study.The drop-out rate was 7.7%.2.At baseline,the score of MMSE,the ADAS-cog scale,ADL scale and TCM syndrome was similar between the two groups(P>0.05).3.After 6-month treatment,significant improvement in total score of MMSE,ADAS-cog,and ADL was observed for both groups(P<0.05),there was significant difference in MMSE,ADAS-cog,and ADL score between the two goups after 6-month treatment(P<0.05).4.Improvement in TCM syndrome integral was observed in the integrative group instead of western medicine group after 6-month treatment(P<0.05).5.There were no serious adverse events observed in the two groups.And the treatment-related adverse reactions were no statistical difference between the two goups(P>0.05).Conclusion:1.Phlegm-resolving Orifice-Opening Decoction combined with Donepezil is superior than donepezil alone in improving cognitive function and daily living function of AD.2.When it comes to,Phlegm-resolving Orifice-Opening Decoction combined with Donepezil instead of donepezil alone can improve the TCM syndrome.3.Phlegm-resolving Orifice-Opening Decoction combined with Donepezil is safe with the clinical use.