| ObjectiveThis study is divided into two parts,to elucidate the current status of the treatment of behavioral and psychological symptoms of dementia(BPSD)through literature research,and to explore the clinical efficacy and safety of traditional Chinese medicine for BPSD through systematic evaluation.MethodsThe first part is the literature research aimed to consult the relevant literature of BPSD,and summarize the current medical understanding of BPSD from two aspects of traditional Chinese medicine and western medicine.The second part,we performed a systematic literature review using the CNKI,Wanfang,VIP,Sinomed,PubMed,the Cochrane Library and Embase database from the establishment of these databases through February 2020 to identify randomized controlled trials(RCTs)of traditional Chinese Medicine evaluating the clinical efficacy and safety of the treatment of BPSD.Two evaluators independently conduct literatureretrieval according to the established retrieval strategy,select the literature and extract the data according to the inclusion and exclusion criteria,and evaluate the quality of the literature.If there is a difference between the two parties,the two sides will resolve them through consultation,if not decided by the third evaluator.Review Manager 5.3 was used to perform the meta-analysis.ResultsTwenty studies,with a total of 2124 patients,met inclusion criteria eventually,including 1069 patients in the trial group and1055 patients in the control group.The results of Meta analysis show that:1.8 RCTs involving 702 patients were included in the TCM group VS western medicine group,including 351 patients in the TCM group and 351 patients in the western medicine group.The reduction of NPI score and BEHAVE-AD score and ADL score in the TCM group was better than that in the western medicine group.The incidences of adverse reactions,drowsiness,dizziness/headache and extrapyramidal signs in the TCM group were significantly lower than those in the western medicine group.There was no significant difference in the increase of MMSE score between the TCM group and the western medicine group.There was no significant difference in the total effective rate,the incidence of constipation and the incidence of insomnia between the TCM group and the western medicine group.2.10 RCTs involving 877 patients were included in the integrated traditional Chinese and western medicine group VS western medicine group,including 443 patients in the integratedtraditional Chinese and western medicine group and 434 patients in the western medicine group.The total effective rate of integrated traditional Chinese and western medicine group was significantly higher than that of western medicine group.The improvement of ADL score and HDS score in the integrated traditional Chinese and western medicine group was better than that in the western medicine group.The incidence of adverse reactions in the integrated traditional Chinese and western medicine group was lower than that in the western medicine group.There was no significant difference in the incidence of constipation,nausea,fatigue,diarrhea,dry mouth,insomnia,drowsiness and dizziness between the integrated traditional Chinese and western medicine group and the western medicine group.3.5 RCTs involving 412 patients were included in TCM group VS antipsychotic group,including 206 patients in the TCM group and206 patients in the antipsychotic group.There was no significant difference in the total effective rate and insomnia incidence between the TCM group and the antipsychotic group.The reduction of BEHAVE-AD score in the TCM group was better than that in the antipsychotic group.The incidences of adverse reactions,drowsiness,dizziness / headache and extrapyramidal signs in the TCM group were lower than those in the antipsychotic group.4.4 RCTs involving 342 patients were included in TCM combined with antipsychotic group VS antipsychotic group,including 171 patients in the TCM combined with antipsychotic group and 171 patients in the antipsychotic group.The total effective rate of the TCM combined with the antipsychotic group was higher than that of the antipsychotic group.The TCM combined with antipsychoticgroup was superior to the antipsychotic group in reducing the BEHAVE-AD score and increasing the MMSE score.The incidence of adverse reactions in the TCM combined with the antipsychotic group was lower than that in the antipsychotics group.There was no significant difference in the incidence of drowsiness,dry mouth,insomnia,constipation,nausea and dizziness between the TCM combined antipsychotic group and the antipsychotic group.5.4 RCTs involving 344 patients were included in TCM combined with Donepezil group VS Donepezi group,including 178 patients in the TCM combined with Donepezil group and 166 patients in the Donepezi group.There was no significant difference in the improvement of MMSE score between the TCM combined with Donepezil group and the Donepezil group.There was no significant difference in the incidence of diarrhea,insomnia,nausea and dizziness between the TCM combined with Donepezil group and the Donepezil group.Conclusion1.The efficacy and safety of traditional Chinese medicine in the treatment of BPSD are better than that of western medicine,and the effect of improving cognitive function is similar to that of western medicine.2.The efficacy and safety of integrated traditional Chinese and western medicine in the treatment of BPSD are better than that of western medicine,and the effect of improving cognitive function is better than that of western medicine alone.3.The efficacy of traditional Chinese medicine in the treatment of BPSD is not inferior to that of antipsychotics,and its safety is better than that of antipsychotics.4.The efficacy and safety of TCM combined with antipsychotics in the treatment of BPSD were better than that of antipsychotics alone,and the effect of improving cognitive function was better than that of antipsychotics alone.5.TCM combined with Donepezil is similar to Donepezil alone in improving cognitive function and safety in patients with BPSD.At present,the evidence does not support the combination of TCM combined with Donepezil.Due to the small sample size and the generally low quality of included studies,this conclusion still needs support from large sample,multi-center,high-quality randomized controlled research. |
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