| Objective:1.Looking for evidence of acupuncture treatment for PSCI through systematic review of previous literature.2.To explore the effect of heart-gallbladder-kidney acupuncture integration scheme in the treatment of PSCI,and the role of improving patients’ quality of life and activities of daily living,through clinical randomized controlled study.Methods:1.Systematic review of literatureTo evaluate the clinical effect of acupuncture on PSCI,we search the domestic and international RCT literature between January 1989 to June 2016 about acupuncture treatment for PSCI,and to assess research problems and improvement direction objectively.And,Chinese search words included"Acupuncture and Moxibustion" or "Acupuncture" and ’"Post-stroke cognitive cognitive impairment" or "Cognitive Impairment" or "Stroke" or "Brain Infarctions",while English search words included "Acupuncture" or"Moxibustion" and "Post-stroke cognitive impairment" or "Stroke" or"Cognitive impairment",searched the relevant literature on the treatment of PSCI published in the official academic journals in the Chinese Biomedical Medical Database(CBM),Chinese biomedical database(VIP),China National Knowledge Infrastructure(CNKI),China science literature network publish general storeroom(CAJD)and wanfang database(WF);English databases are Pubmed database,Embase medicine database,Cochrane Collaboration center registration database,JSTOR,LISTA with Full Text Library information and scientific and technological database,Ovid Platform for medical electronic journals.Each database was searched in order to avoid omission and manual retrieval was used as supplement.By reading the title,abstract and full text,randomized controlled literature consistent with inclusion criteria were screened out,then systematic evaluation and Meta analysis on its quality were carried out.2.Clinical research105 patients met the inclusion criteria were selected as subjects,setting up heart-gallbladder-kidney acupuncture treatment group,sham acupuncture group and western medicine control group,patients were randomly distributed in the three groups according to 1:1:1,35 patients in each group.The heart-gallbladder-kidney acupuncture treatment group:when in treatment,first,acupuncture at Baihui and Yintang acupoint,or flat acupuncture at 4-5mm depth,then acupuncture at Neiguan,Yanglingquan,Taixi,zulinqi acupoint at 10-12mm,using uniform lifting and twirling manipulation,leaving the acupuncture at these acupoint for 30 min.Then,using moxibustion at bilateral Danshu,Geshu,Yongquan acupoint,the moxa cone as Conic,about 1 cm high,the bottom cone diameter was 0.8cm,0.1g in weight,when moxa burning close to 2/3,and the patient had warm or mild pain,using cotton bud to remove the unburned moxa cone,a total of 5 times of moxibustion should be carried out at each point.Finally,horizontal insertion at bilateral Xinshu,Shenshu acupoint from outside to the spine along subcutaneous,5mm intradermal needling body should be penetrated in,and the needle handle left on the skin,then,using medical tape to fix,after 2 days,tore the tape,and removed the intradermal needle.Sham acupuncture group:including sham acupuncture,sham moxibustion,and sham intradermal needling,acuacupoint selection and specifications of moxa cone were same as the heart-gallbladder-kidney acupuncture treatment group,only tools and operating methods were different.When in treatment,the adhesive ring of nested blunt needle should be fixed on the acuacupoint,then using 1 inch blunt needle to puncture into skin surface,then,bottom adhesive support ring was fixed at the acupuncture point,remaining for 30min.Then,using moxibustion,when moxa burning close to 1/3,and the patient had no warm feeling,removing the moxa cone.Finally,blunt intradermal needling should be used,not required puncturing into the skin,indwelling for 2 days.Western medicine control group:orally taking Donepezil Hydrochoride Tablets 5mg qn,if there as no adverse reaction,then taking a continuous time of 12 weeks.2 times a week in heart-gallbladder-kidney acupuncture treatment group and sham acupuncture group,each treatment interval>48h,a total of 12 weeks,follow-up for 3 months.In 6 different points of before treatment,after 4 weeks of treatment,after 8 weeks of treatment,at the end of treatment(after 12 weeks of treatment),after the end of treatment for 1 months,and after the end of treatment for 3 months,MMSE,MoCA,SS-QOL and ADL scale were respectively used to measure to make evaluation on the recent and mid-term efficacy of does heart-gallbladder-kidney acupuncture comprehensive scheme in treating cognitive impairment post stroke,meanwhile,compared with sham acupuncture group and medicine group to investigate the effect of different groups on cognitive impairment post stroke,and safety assessment should be made on the untoward effects recorded in the whole process.The statistical analysis methods including Descriptive statistics,Chi-square test,Kruskal-Wallis test,Analysis of variance,Pearson’ s correlation and Cluster analysis were analyzed by SPSS 18.0 software.Results:1.Literature systematic evaluationAccording to the established search strategy,a total of 982 articles were retrieved,and 301 articles were excluded and the remaining 681articles.According to the research purpose,inclusion criteria and exclusion criteria,a total of 666 unqualified articles were excluded,and finally,15 articles were included,all were Chinese articles,the remaining were excluded because of the error of the random method,inaccurate data,intervention and evaluation indexes not in conformity with the inclusion criteria.These 15 studies included 555 patients in the treatment group,530 in the control group,a total of 1085 patients.Among the 5 studies,the total effective rate was evaluated.The fixed effect model was used,the combined effect of OR was 3.11,combined effect test statistic was Z=3.90,and there was significant difference between the treatment group and the control group(P<0.0001),it could be considered that the effect of the treatment group was better than that of the control group.The included 7 studies used MMSE scale for efficacy evaluation.After heterogeneity test,there was a large heterogeneity(P<0.01,I2>50%),indicating two groups were not homogeneous,and random effects model was used,WMD=2.76,95%CI(2.23,3.29),the results showed that there was significant difference between the treatment group and the control group(P<0.01),and the effect of the treatment group was better than that of the control group.At the same time,the fixed effect model was used to analyze the results,the results showed that the stability was relatively high.The included 5 studies used MoCA scale for efficacy evaluation,after heterogeneity test,there was a large heterogeneity(P<0.01,I2>50%),and random effect model was used,WMD=2.33,95%CI(1.15,3.51),the results showed there was significant difference between the treatment group and the control group(P<0.01),and the therapeutic effect of the treatment group was better than that of the control group.Meanwhile,the fixed effect model was used to analyze the results,the results showed that the stability was relatively high.The included 4 studies used ADL scale for efficacy evaluation,random effect model was used,WMD=9.60,95%CI(6.73,12.48),results showed that there was significant difference between the treatment group and the control group(P<0.01),and the therapeutic effect of the treatment group was better than that of the control group.Meanwhile,the fixed effect model was used to analyze the results,the results showed that the stability was relatively high.The included 4 studies compared the curative effect of acupuncture combined therapy group and drug group,after heterogeneity test,the results showed that there was homogeneity of each study,and fixed effect model was used,OR=3.28,95%CI(1.77,6.08),by pooled effect test:Z=3.37(P=0.0002),there was a significant difference between the two groups,it can be concluded that acupuncture combined therapy was better than western medicine in the treatment of post-stroke cognitive impairment.In the random effects model,OR=3.27,95%CI(1.76,6.07),and the pooled effect value test:Z=3.77(P=0.0002),it also suggested that acupuncture combined therapy was better than western medicine in the treatment of post-stroke cognitive impairment,and the stability of the result was high.The included 3 studies used MMSE scoring to compare the efficacy of acupuncture combined therapy group and cognitive training control group,there was homogeneity of research,and fixed effect model was used,WMD=2.98,95%CI(2.40,3.18),the results showed that there was significant difference between the treatment group and the control group(P<0.01),and the therapeutic effect of acupuncture combined therapy group was better than that of the cognitive training control group.2.Clinical research(1)Shedding casesIn this study,105 cases were included in the final study,the actual completion of 98 cases,shedding in 7 cases,shedding rate was 6.7%.No shedding case in the heart-gallbladder-kidney acupuncture treatment group,2 shedding cases in medicine group(2 cases stopped of severe adverse drug reactions),5 in sham acupuncture group(2 cases could not be treated because of other diseases,3 cases of perceived poor efficacy).(2)Baseline dataChi-square test or analysis of variance was carried out on the situations of age,gender,occupation,education level,course of disease,whether or not having the treatment of post-stroke cognitive impairment,whether there was a family history in three groups of patients before treatment,there was:no significant difference between the three groups(P>0.05),considering the baseline level of the patients in the three groups was consistent and comparable.(3)MMSE,MoCA,SS-QOL,ADL scale scoreMMSE scales score:There was no statistical significance for the MMSE scales score of three groups patients(P=0.637)and the baseline was balanced..Comparison in groups after treatment:the score of groups including heart-gallbladder-kidney acupuncture treatment,medicine control and sham acupuncture was increased respectively at each time compared with that before treatment,the increased range had statistical significance,and P<0.05,which indicated that the situation of three groups was improved after treatment.Comparison between groups:In the 4th,8th,12th week in treatment and the first,third month after treatment,heart-gallbladder-kidney acupuncture treatment group and medicine control group was compared with sham acupuncture group respectively,and the difference was statistically significant among groups(P<0.05)but the comparison result between heart-gallbladder-kidney acupuncture treatment group and medicine control group was no statistically significance(P<0.05).MoCA scales score:There was no statistical significance for the MoCA scales score of three groups patients(P=0.357)and the baseline was balanced.Comparison in groups after treatment:In the 4th,8th,12th week in treatment and in the first month after treatment,the score of groups including heart-gallbladder-kidney acupuncture treatment,medicine control and sham acupuncture was increased respectively in same time compared with that before treatment,and increased range had statistical significance(P<0.05),indicated that the situation of three groups was improved after treatment.After 3 month of treatment,the heart-gallbladder-kidney acupuncture treatment group and and medicine control group was compared with that before treatment respectively,and there was statistical significance for the difference among groups(P=0.002,P=0.048),but there was no statistical significance when the sham acupuncture group was compared with that before treatment(P=0.295).Comparison between groups:in the time for 4th,8th,12th week in treatment and one month,three month after treatment,the heart-gallbladder-kidney acupuncture treatment group and medicine control group was compared with sham acupuncture group respectively,and the difference was statistically significant among groups(P<0.05),but the comparison result between heart-gallbladder-kidney acupuncture treatment group and medicine control group doesn’ t have statistical significance(P>0.05).SS-QOL scales score:There was no statistical significance for the SS-QOL scales score of three groups patients(P=0.081)and the baseline was balanced.Comparison in groups after treatment:the SS-QOL score of groups including heart-gallbladder-kidney acupuncture treatment,medicine control and sham acupuncture was increased respectively at each time compared with that before treatment,the increased range had statistical significance,and P<0.05 indicated that the situation of three groups was improved after treatment.Comparison between groups:in the 4th,8th,12trh week in treatment and the first,third month after treatment,heart-gallbladder-kidney acupuncture treatment group was compared with medicine control group and sham acupuncture group respectively,and the difference was statistically significant among groups(P<0.05),but the medicine control group was compared with sham acupuncture group in the 4th week in treatment,the difference was not statistically significant(P=0.476),and the comparison result between medicine control group and sham acupuncture group did have statistically significance in the 8th,12th week in treatment and the first,third month after treatment(-P=0.029,P=0.000,P=0.033,P=0.000).ADL scales score:There was no statistical significance for the ADL scales score of three groups patients(P=0.055)and the baseline was balanced.Comparison in groups after treatment:the score of heart-gallbladder-kidney acupuncture treatment group at each time was increased respectively compared with that before treatment and the increased range had statistical significance,the P<0.05 indicated that the score of heart-gallbladder-kidney acupuncture treatment group was improved after treatment.In the 4th week in treatment,medicine control group and sham acupuncture group were compared with that before treatment respectively,and the difference was not statistically significant among groups(P=0.062,P=0 105)but in the 8th,12th week and one month,three month after treatment,the heart-gallbladder-kidney acupuncture treatment group was compared with the medicine control group and sham acupuncture group respectively and the difference did have statistical significance(P<0.05).Comparison between groups:in the 4th,8th,12th week treatment and the first and the third month after treatment,heart-gallbladder-kidney acupuncture treatment group was compared with medicine control group and sham acupuncture group respectively and the difference did have statistical significance(P<0.05),in the 4th week,the medicine control group was compared with sham acupuncture group and there was no statistical significance for difference(P=0.197).In the 8th,12th week and the first and third month after treatment,the medicine control group was compared with sham acupuncture group and there was statistically significance for difference(P=0.000,P=0.000,P=0.014,P=0.000).After repeated measurement,the result of multivariate analysis of variance prompts that the influence of different time factors on the score value of each MMSE,MoCA,SS-QOL,ADL scale all have statistical significance.The difference of treatment effects between different groups has also statistical significance.Each observation point is regarded as an individual difference factor,and the score difference at different time points all have statistical significance(P<0.05),the different intervention methods as the difference between individuals has also statistical significance(P<0.05).In the evaluation that MMSE and MoCA as main outcome index,the outcome of heart-gallbladder-kidney acupuncture treatment group and medicine control group at each time was better than that sham acupuncture group,and in the evaluation that SS-QOL and ADL as main outcome index,the outcome after treatment of heart-gallbladder-kidney acupuncture treatment group at each time was better than that medicine control group and sham acupuncture group,except the 4th week and in the rest of time the medicine control group outcome was better than sham acupuncture group.The time that outcome reached to the best was in 12 weeks after treatment and in the follow-up visit the score was decreased in different degrees and with the time extension of follow-up visit,the decrease degree was increased then before.(4)Total effective rateFor the total effective rate at different time points after treatment,the heart-gallbladder-kidney acupuncture treatment group,western medicine control group were compared to the sham acupuncture group,the difference was statistically significant(P<0.05).4th weeks after treatment,the heart-gallbladder-kidney acupuncture treatment group(82.86%),the western medicine control group(81.82%)were compared to sham acupuncture group(36.67%),the difference was statistically significant(P<0.05);8th week after treatment,the heart-gallbladder-kidney acupuncture treatment group(88.57%),the western medicine control group(84.85%)were compared to sham acupuncture group(46.67%),the difference was statistically significant(P<0.05);and 12th week after treatment,the heart-gallbladder-kidney acupuncture treatment group(91.43%),the western medicine control group(90.91%)were compared to sham acupuncture group(56.67%),the difference was statistically significant(P<0.05);1 months after treatment,the heart-gallbaldder-kidney acupuncture treatment group(88.57%),the western medicine control group(84.85%)were compared to sham acupuncture group(53.33%),the difference was statistically significant(P<0.05);and 3 months after treatment,the heart-gallbladder-kidney acupuncture treatment group(85.72%),the western medicine control group(75.76%)were compared to sham acupuncture group(46.67%),the difference was statistically significant(P<0.05);and the heart-gallbladder-kidney acupuncture treatment group(85.72%)was compared to medicine control group(75.76%),the difference was statistically significant(P<0.05).In the evaluation of the total effective rate as the main therapeutic index,efficacy of each point after treatment in heart-gallbladder-kidney acupuncture treatment group and medicine control group was better than that of sham acupuncture group,of which,the best efficiency in heart-gallbladder-kidney acupuncture treatment group,followed by medicine control group.(5)The near-to mid-term effect of each group after treatment1 month after treatment,the heart-gallbladder-kidney acupuncture treatment group and sham acupuncture group were compared in 4 scales of MMSE,MoCA,SS-QOL,ADL,the difference was statistically significant(P<0.05),its short-term effect was better than that in sham acupuncture group;compared with medicine group,only in the SS-QOL scale that is,the quality of life,the difference was statistically significant(P<0.05),while in MMSE,MoCA,ADL,the difference was not statistically significant(P>0.05),indicating these two maintained a considerable effect in MMSE,MoCA,ADL;compared medicine group with sham acupuncture group,the differences were not significant(P>0.05),which showed that the medicine group had no obvious advantage in maintaining the short-term effect.3 months after treatment,the heart-gallbladder-kidney acupuncture treatment group and sham acupuncture group were compared in 3 scales of MMSE,SS-QOL,ADL,the difference was statistically significant(P<0.05),in MoCA,the differences were not significant(P>0.05);with the extension of the follow-up period,in addition to MoCA evaluation,the mid-term maintenance effect of heart-gallbladder-kidney acupuncture treatment group should have advantage;compared with medicine control group,in SS-QOL score,the difference was statistically significant(P<0.05),indicating’ that the efficacy maintenance of heart-gallbladder-kidney acupuncture group was better than that in medicine group in terms of quality of life,while in MMSE,MoCA,ADL,the difference was not statistically significant(P<0.05),indicating that these two maintained a.considerable degree of effect in MMSE,MoCA,ADL;compared medicine group with sham acupuncture group,the differences were not significant(P<0.05),which showed that the medicine group had no obvious advantage in maintaining the mid-term effect.(6)Relationship between post-stroke cognitive impairment and quality of life and activities of daily livingMMSE and MoCA were combined into two cognitive impairment variables,Correlation analysis between quality of life and activities of daily living in patients after stroke was made,it could be seen that there was a positive correlation between the two,and the correlation coefficients were 0.808 and 0.888,respectively,indicating there was correlation between cognitive function and quality of life and activity of patients with post-stroke cognitive impairment.(7)The maintained therapeutic effect of sham acupuncture group on patients’ psychological suggestionClustering was made according to the efficiency of sham acupuncture group,found in the treatment stage 2,3,4(Eighth week,Twelfth week was most close to 1 months after the end of treatment,and the efficiency was highest.Time limit to maintain efficacy of psychological suggestion of patients in sham acupuncture group was from the end of 8 weeks after treatment to 1 month after treatment.(8)Safety evaluationThere were 2 cases of adverse reactions in the medicine group,including nausea and diarrhea in 1 case,and dizzy symptom in other case,thus,subject test was ceased in time,adverse reaction report was recorded.While,no adverse reaction appeared in heart-gallbladder-kidney acupuncture treatment group and sham acupuncture group.Conclusion:1.Evaluation of the literature in this paper believes that the effect of acupuncture on improving post-stroke cognitive impairment is better than drugs and other interventions.However,as the quality of the literature included in the study is low,there is a lack of uniform criteria for efficacy evaluation,therefore,large sample and high quality clinical researches with strengthened unified standard of curative effect are required.2.This clinical study shows heart-gallbladder-kidney acupuncture integration scheme and Donepezil Hydrochloride Tablets can effectively improve the cognitive function in patients with post-stroke cognitive impairment,and they are both better than those in sham acupuncture group.In terms of improving the quality of life and daily activities,heart-gallbladder-kidney acupuncture integration scheme,which shows no adverse reaction and demonstrates good application prospects and promotion value,has been proved to have a better effect than Donepezil Hydrochloride Tablets and sham acupuncture. |
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