Clinical Study On Treatment Of Mild Cognitive Impairment With Kidney - Spleen - Spleen And Phlegm

Objective:To evaluate the efficacy and safety of treating aMCI under the guidance of principle of tonifying kidney, spleen and resolving phlegm.Methods:The study consists of three parts:(1)Systematically reviewing the published MCI clinical medicine research by means of searching literatures about clinical randomized controlled studies of treating MCI with Chinese material medica from CNKI,CBM, PubMed and Embase, time limited between 2000 and 2015.Then extracting data and carrying out meta analysis with the help of RevMan5.3.0.(2)Adoptingcross-section design. To begin with, recruiting subjects and all subjects accept neuropsychological assessment, MRI, biochemical examination and syndrome differentiation of traditional Chinese medicine, as well as the evaluation of vascular conditions. Next, observing whether aMCI patients with vascular risk factors would severe cognitive damage and analyzing the correlationsbetweencognitive function and vascular factors, TCM syndromes and demographic features. (3)Carrying out blank control experiment. According to the method of tonifying kidney, spleen and resolving phlegm, subjects in experimental groups accept drug intervention for 12 weeks andcognitive function and TCM syndromes are collected asefficacy indications. Meanwhile, pharmacovigilance is assessed..Results:(1)The first part of evidence-based medical research collected 36 clinical studies treating MCI with Chinese material medica. Meta analysis showed that TCM group was superior to placebo group in improving MMSE scores[MD=1.76,.P<0.05]and reducing the conversion rate of dementia[MD=0.21,P<0.05]; Results of TCM group were also superior to basic treatment group in improving MMSE scores[MD=0.90,P<0.05], MQ[MD=6.62,P<0.05]and CDT scores[MD=0.26,P<0.05];Results of TCM group were significantly better than Zetham drugs group in improving MMSE scores[MD=0.78,P<0.05]and reducing TCM symptoms [MD=-6.85,P<0.05].TCM group was also better than ergot medicine group in improving MMSE[MD=4.12,P<0.05] and reducing TCM symptoms [MD=-4.14,P<0.05];TCM treatment has the same effects with donepezil treatment in improving MMSE [MD=-0.27,P>0.05],ADAS-cog scores[MD=0.38, P>0.05],IADL[MD=-0.58,P>0.05],and reducing TCM symptoms [MD=-1.16,P>0.05]. However, specific records of pharmacovigilance of 35 clinical trials was ignored so that meta analysis of safety of treating MCI with Chinese material medica didn’t be carried out.(2)The second part of cross-sectional clinical observational studies found that aMCI+VF group and aMCI-VF group had statistic difference in yang hyperactivity syndromes of TCM (P=0.024),but no statisticdifference in ADAS-cog and MMSE(P>0.05). Word recognition in ADAS-cog had a positiverelationto HR(r=0.304,P=0.002); Following commands in ADAS-cog had a positiverelationto BMI(r=0.290,.P=0.003).(3)The third part of this study is the blank control research ofexperimental group which was under the guidance of treatment principle of tonifying kidney, spleen and resolving phlegm.There were 78 cases in treatment group and 15 cases in control group. Treatment lasted for 12 weeks. Average change of ADAS-cog of treatment group was-0.82, comparing with which in control group 0.33, it demonstrated a statistic difference (P=0.027);Average change of MMSE of treatment group was 1.14, which was-0.67 in control group.Treatment group was better than control group(P=0.000);The average changeof kidney deficiency, spleen deficiency and phlegm were also different in two group (P=0.001, P=0.026, P=0.000), TCM group is better than blank control group. In the whole process of the trial, there were 5 cases (6.4%) of adverse events (AEs) in total, one cases was sure to connected with medication (Chinese medicine allergy), and no serious adverse events(SAEs) happened.Conclusion:Cross-section observational studies revealed that although vascular factors may be one of causes of cognitive impairment, they don’t severe the impairment of overall cognitive function of aMCI patients. Treatment principle of tonifying kidney, spleen and resolving phlegm could be a new way to cure aMCI, and long course and large sample of clinical studies are needed in the further confirming.