| Objective1.Through Meta analysis of paper on acupuncture and moxibustion for carotid atherosclerotic plaque in recent 15 years,explore the evidence of acupuncture and moxibustion for carotid atherosclerotic plaque was explored.2.A randomized controlled trial was conducted to evaluate the effectiveness of "treatment of heart and gallbladder" acupuncture and moxibustion in the treatment of carotid atherosclerotic plaque by comparing the acupuncture and moxibustion group,western medicine group and sham acupuncture and moxibustion group.MethodsPart 1 Literature evaluationMeta-analyze the RCT experiment of acupuncture and moxibustion in the treatment of carotid atherosclerotic plaques published from December 31,2003 to December 31,2018,and evaluate the clinical efficacy of acupuncture and moxibustion in the treatment of carotid atherosclerotic plaque.In computer research,Chinese databases were selected as CNKI,Wanfang,WeiPu and CBM,while English databases were selected as Pubmed,EMBASE and Cochrane Central Register of Controllde Trials.The reference database was established with NoteExpress3.2,and the literatures should match the inclusion criteria,the Meta-analysis was conducted with RevMan5.3 software.1.Search strategyKeywords:acupuncture,electroacupuncture,abdominal acupuncture,head acupuncture,body acupuncture,carotid atherosclerosis,carotid atherosclerosis,carotid plaque,carotid thickening,carotid plaque,etc.The keywords are connected with OR,AND,NOT.2.Quality evaluationThe "risk of bias assessment" worksheet customized by Cochrane collaboration,and the evaluators were independently and parallel by Zhou junhe and Zhao Lin.In the process of reading,if there were different opinions,they would be solved by the third evaluator Ning baile.3.Statistical analysisFor dichotomous variables,event occurrence counting method was used for statistics,and the variable data was expressed by mean difference value(MD).According to the heterogeneity test,fixed effect model or random effect model was selected for analysis.In the process of result calculation,the confidence interval was selected as 95%,and the difference was considered statistically significant when P<0.05,and its statistical value was recorded.Part 2 Clinical studyRandom Numbers were generated by SPSS20.0 software,and 90 patient were divided into 3 groups according to the ratio of 1:1:1.Finally 83 patient were selected,28 patient in the acupuncture group,27 cases in the drug group and 28 cases in the sham acupuncture group.1.Grouping Settings(1)acupuncture group①AcupointAcupuncture:Baihui,Yitang,Renying(double),Neiguan(doubule),Yanglingquan(double);Moxibustion:Zhongwan,Xiawan,Qihai,Guanyuan,Geshu,Danshu;Intradermal acupuncture:Xinshu(double),Danshu(double)Location of acupoints refer to the 2006 national standards of the People’s Republic of China(GB/t12346-2006)name and location of acupoints②OperationPatients were placed in the supine position,and first acupuncture at Neiguan(double),Yanglingquan(double)and Renying(double),followed by acupuncture at Baihui and Yitang.All of them used a thimble needle,and then a conventional needle was inserted into the lower base to break the skin,and inserted into the acupoint.The twist manipulation was performed until the patient felt local acid and analgesia.Moxibustion is performed according to the corresponding acupoints.Each acupoint is moxibussed with a conical moxa with a height of 3mm and a diameter of 2mm on the bottom surface.Removed the moxa when the moxa burns to the remaining 1/3,and each acupoint burning twice.The intradermal needle was conventionally operated,and the needle was retained for 48h.2.Drug groupAspirin 100mg po qd,Atorvastatin 10mg po qn.3.Shame acupuncture groupPatients were placed in supine position,disposable nested needles were selected,acupuncture needle sets were fixed,and the flat head needle was inserted into the set,so that the needle touched the patient ’ s skin and produced slight pain.The acupuncture points were selected in the same acupuncture group.Fine moxibustion according to the corresponding acupoint operation,each acupoint with a specification of 3mm high,the bottom diameter of 2mm conical moxibustion,the moxa with ten thousand flower oil soaked,so that it can not burn,from the moxa wick tip with incense burn moxa wick action,and scratching around its acupoints,moxibustion each point twice.Use the flat head intradermal needle,stick it on the skin,fix it with adhesive tape,and keep the needle for 48h.2.The period of treatmentTreatment course was 12 weeks,once every 3 days,a total of 24 times of treatment was completed,80%of which was the effective case,and a follow-up was conducted 12 weeks after the end of treatment.3.Evaluation of time points and indicatorsWeek 0,12 and 24 were selected as evaluation points for evaluation.IMT,plaque thickness(course integral),plaque volume,plaque gray scale(GSM),triglyceride(TG),total cholesterol(TC),low-density lipoprotein(LDL)and high-density lipoprotein(HDL)were measured at each evaluation point.The platelet aggregation(ADP),blood clotting FIB,platelet count and apolipoprotein A-IV were detected in 20 patients in the acupuncture group at week 0 and 12.4.StatisticsAppropriate statistical analysis methods were selected according to the nature of clinical trial data(measurement,classification and grading).The classified data were tested by chi-square test or precise probability method.The measurement data were first tested by normality test and homogeneity of variance test.Wilcoxon rank sum test was used to compare the unsatisfied samples and Wilcoxon rank sum test was used to compare the unsatisfied samples.Rank data were tested by Wilcoxon rank sum test(calibration)for sample comparison or kruskal-wallis test for multiple group comparison.Repeated measures anova was used for quantitative main outcome indicators at multiple observation points.Using a bilateral test,baseline comparison test level=0.05,efficacy comparison between groups test level=0.05,pairwise comparison between groups=0.0167.Results1.Literature study resultsThrough literature retrieval,a total of 142 related literatures were retrieved.58 literatures were preliminarily selected by reading titles and s,and the remaining 13 literatures were selected after reading the full text.(1)OutcomeUltrasonic aspectsCarotid medial media thickness(IMT)In terms of combined IMT(total),7 literatures were included and P=0.002,I2=71%were found after heterogeneity test.Select the random effect model,and the result is P=0.03.It can be seen that acupuncture or acupuncture combined therapy,as well as the two therapies combined with medicine respectively,is superior to the medicine alone in improving the thickness of carotid artery medial media.In terms of left carotid intima-media thickness,2 studies were included,but 1 study was divided into 2 independent studies for analysis because 3 groups were used for comparison.Heterogeneity test P<0.05,I2=91%,using the random effect model,analysis P=0.46.It can be concluded that acupuncture or acupuncture combined therapy,as well as the combination of the two therapies with western medicine respectively,has similar efficacy in improving the thickness of the left carotid artery medial media compared with the western medicine alone.In terms of the thickness of the medial media of the right carotid artery,the analysis results showed that the heterogeneity test P=0.05,I2=66%,select the random effect model and the result is P=0.77.It can be concluded that acupuncture or acupuncture combined therapy,as well as the combination of the two therapies with western medicine respectively,is equally effective in improving the thickness of the internal and middle carotid artery compared with the western medicine alone.Plaque thicknessAmong the 13 included literatures,a total of 7 literatures adopted plaque thickness as the outcome indicator,P=0.99 and I2=0%were obtained by heterogeneity test,and fixed effect model was selected,P<0.05 was obtained by analysis.It can be concluded that acupuncture or acupuncture combined therapy,as well as the combination of the two therapies with western medicine respectively,is superior to the western medicine group in improving the plaque thickness.Plaque areaIn terms of patch area,there were 4 literatures using patch area as outcome index,P=0.53 and I2=0%after heterogeneity test,fixed effect model was selected,and P=0.01 was obtained through analysis.It can be concluded that acupuncture or acupuncture combined therapy,as well as the two therapies combined with western medicine respectively,is superior to western medicine alone in the improvement of carotid artery plaque area.Blood lipidIn terms of triglycerides,7 studies were included,heterogeneity test P=0.92,I2=0%,fixed effect model was adopted,and P<0.01 was obtained.Therefore,western medicine therapy is better than acupuncture or acupuncture combined therapy in reducing triglycerides.In terms of total cholesterol(TC),7 studies were included,heterogeneity test P=0.010,I2=62%,random effect model was adopted,and P=0.56 was obtained.Thus,in terms of cholesterol reduction,acupuncture or acupuncture combined therapy,or the two therapies combined with western medicine respectively,have the same efficacy as western medicine alone.In terms of low-density lipoprotein(LDL),7 studies were included,and heterogeneity test P=0.004,I2=66%.Random effect model was adopted,and P=0.50 was obtained.Thus,in terms of lowering LDL,acupuncture or acupuncture combined therapy,or the two therapies combined with western medicine respectively,have the same efficacy as western medicine alone.In terms of high-density lipoprotein(HDL),7 studies were included,heterogeneity test P<0.01,I2=82%,random effect model was adopted,and P=0.85 was obtained.It can be concluded that acupuncture or acupuncture combined therapy,or the combination of the above two therapies with western medicine respectively,is as effective as western medicine alone in raising HDL.HemorheologyIn terms of whole blood viscosity(low-cut),the heterogeneity test P=0.97,I2=0%,and the fixed effect model was used to analyze and obtain P=0.466.The results showed that acupuncture or acupuncture combined therapy,or the above two therapies combined with western medicine respectively,had the same efficacy as the western medicine alone in changing the whole blood viscosity(low-cut).In terms of whole blood viscosity(high cut),two studies were included,heterogeneity test P=0.39,I2=0%,fixed effect model was adopted,and P=0.42 was obtained through analysis.The results showed that acupuncture or acupuncture combined therapy,or the above two therapies combined with western medicine respectively,had the same efficacy as the western medicine alone in changing the whole blood viscosity(high cut).In terms of plasma viscosity,two studies were included,heterogeneity test P<0.01,I2=92%,random effect model was adopted,and P=0.76 was obtained.The results showed that acupuncture or acupuncture combined therapy,or the combination of the above two therapies combined with western medicine respectively,was as effective as western medicine alone in changing plasma viscosity.HemodynamicallyIn terms of the maximum systolic blood flow velocity(EDV),two studies were included,with the heterogeneity test P=0.25 and I2=26%.The fixed effect model was used to analyze and obtain P<0.01.The results showed that acupuncture or acupuncture combined therapy,or combination of the above two therapies combined with western medicine,was superior to western medicine alone in changing the maximum systolic blood flow velocity(PSV).In terms of the minimum diastolic blood flow velocity(EDV),two studies were included,with the heterogeneity test P=0.25 and I2=26%.The fixed effect model was used to analyze and obtain P<0.01.The results showed that acupuncture or acupuncture combined therapy,or combination of the above two therapies combined with western medicine,was superior to western medicine alone in changing the minimum diastolic blood flow velocity(EDV).In terms of pulse index(PI),two studies were included,heterogeneity test P=0.005,I2=88%,random effect model was adopted,and P=0.82 was obtained.The results showed that in terms of the change of pulse index(PI),acupuncture or acupuncture combined therapy,or the above two therapies combined with western medicine respectively,had the same efficacy as the western medicine therapy alone.In terms of resistance index(RI),two studies were included,heterogeneity test P=0.04,I2=75%,random effect model was adopted,and P=0.004 was obtained.The results showed that in terms of changing resistance index(RI),acupuncture or acupuncture combined therapy,or combination of the above two therapies with western medicine method,was superior to the western medicine therapy alone.(2)overall efficiencyAmong the 13 included literatures,total effective rate was used as outcome index in 6 literatures,P=0.02 and I2=59%of the results of the heterogeneity test,random effect model was selected,and P=0.12 was obtained through analysis.The results showed that acupuncture or acupuncture combined therapy,and the combination of the two therapies with western medicine respectively,were comparable to western medicine in terms of effective rate.2.Clinical study results(1)BaselineUp to December 27,2018,a total of 83 effective patient were included in this study,including 28 cases in the acupuncture group,27 cases in the drug group and 28 cases in the sham acupuncture group.There were no significant differences among the three groups in terms of gender(P=0.889),age(P=0.055),BMI(P=0.490),systolic blood pressure(P=0.183),diastolic blood pressure(P=0.681),gender(P=0.889),and smoking status(P=0.064).(2)UltrasoundIMT aspectsIn terms of intra-group comparison,before and after IMT treatment of the left carotid artery in the acupuncture and moxibustion group(P=0.043),before and after IMT treatment of the right carotid artery(P=0.025).Before and after IMT treatment of the left carotid artery in the drug group(P=0.537),and before and after IMT treatment of the right carotid artery(P=0.148).Before and after IMT treatment of the left carotid artery in the sham acupuncture group(P=0.663),and before and after IMT treatment of the right carotid artery(P=0.663).In terms of inter-group comparison,there was no statistical difference in IMT between the three groups before treatment.IMT of the left carotid artery(P=0.159)and IMT of the right carotid artery(P=0.271)were comparable.In terms of variance analysis of the left repeat measurement of IMT,there were statistical differences among the three groups under different treatment methods(P=0.037).Two comparison showed that there were statistical differences between the acupuncture group with the drug group and the sham acupuncture group(P=0.026,P=0.026),and no statistical differences between the drug group and the sham acupuncture group(P=0.973).On the right side of IMT,there was no statistical difference between the three groups after the intervention of different treatment methods(P=0.142).In terms of efficacy,IMT(front)-IMT(back)=IMT difference,IMT left difference(P=0.177),and IMT right difference(P=0.110).To sum up,the acupuncture group has the effect of improving IMT,and the acupuncture group is superior to the drug group and the sham acupuncture group in overall improvement of the left IMT in the three groups of subjects,and the efficacy between the drug group and the sham acupuncture group is equal.On the right side of IMT,the three groups showed similar overall improvement.In terms of curative effect before and after treatment,IMT curative effect in left and right carotid arteries of the three groups was comparable.Carotid artery plaque thicknessIn terms of intra-group comparison,the plaque thickness score before and after acupuncture treatment in the acupuncture group(P=0.016);Plaque thickness score before and after treatment in the drug group(P=0.067);The plaque thickness integral before and after sham acupuncture treatment(P=0.474).In terms of inter-group comparison,there was no statistically significant difference in the total course score of carotid artery plaque thickness between the three groups before treatment(P=0.270).Repeated measurement anova was used for inter-group comparison,and there was no statistical difference among the three groups under different treatment methods(P=0.488).In terms of the curative effect before and after treatment,the difference in plaque thickness was calculated after the difference calculation(P=0.678),and there was no statistical difference between the two groups.To sum up,acupuncture and moxibustion has the effect of reducing the thickness of plaque,but the three groups of subjects have the same effect in the change of plaque thickness.Carotid plaque volume(PV)In terms of intra-group comparison,the plaque volume of the acupuncture group before and after treatment(P=0.001);Plaque volume before and after treatment in the drug group(P=0.094);The plaque volume of sham acupuncture group before and after treatment(P=0.813).In terms of inter-group comparison,there was no statistical difference in the total volume of carotid artery plaque(PV)between the three groups before treatment(P=0.968).Repeated measurement anova showed no statistical difference between the three groups under different treatment methods(P=0.888).In terms of curative effect before and after treatment,the difference in plaque volume was calculated after the difference calculation(P=0.016),and there was a statistical difference between the two groups,and there was a statistical difference between the acupuncture and moxibustion group and the sham acupuncture group(P=0.013).To sum up,acupuncture has the effect of reducing plaque volume.The acupuncture group has better efficacy than the sham acupuncture group,and the acupuncture group has the same efficacy as the drug group.The three groups had similar efficacy in overall improvement of plaque volume.The overall volume reduction rates of acupuncture group,western medicine group and sham acupuncture group were 18.2%,10.5%and-1.9%.Carotid plaque gray scale(GSM)In terms of intra-group comparison,before and after GSM treatment for the left carotid artery in the acupuncture group(P=0.020),and before and after GSM treatment for the right carotid artery(P=0.002).Before and after GSM treatment for the left carotid artery(P=0.474),and before and after GSM treatment for the right carotid artery(P=0.005).Before and after GSM treatment for left carotid artery in sham acupuncture group(P=0.940),and before and after GSM treatment for right carotid artery(P=0.368).In terms of inter-group comparison,there was no statistically significant difference in GSM between the three groups before treatment.GSM for the left carotid artery(P=0.114)and GSM for the right carotid artery(P=0.941)were comparable.Repeated measurement anova showed that there was a statistical difference between the left GSM of the three groups under different treatment methods(P=0.010).Two comparison showed that there was a statistical difference between the acupuncture group and the drug group with the sham acupuncture group(P=0.007,P=0.010),while there was no statistical difference between the acupuncture group and the drug group(P=0.876).There was no significant difference between the right GSM repeated measurement anova groups(P=0.207).In terms of curative effect before and after treatment,the left GSM difference value(P=0.017)and the right GSM difference value(P<0.01)were statistically different between the two groups after the difference value calculation.Two comparison showed that there was a difference between the left GSM acupuncture group and the sham acupuncture group(P=0.006),but no statistical difference between the left GSM acupuncture group and the drug group(P>0.05).GSM comparison on the right showed that there were statistical differences between the three groups(P(0.01),and there were statistical differences between the acupuncture group,the drug group and the sham acupuncture group(P<0.01,P<0.01).To sum up,acupuncture has the effect of increasing carotid artery plaque GSM.In terms of overall improvement,acupuncture group and drug group are superior to sham acupuncture group in the improvement of left carotid artery.In terms of efficacy before and after treatment,the acupuncture group was superior to the sham acupuncture group on both left and right sides,and the efficacy was comparable to that of the drug group.The gray scale values of the left side plaque in the acupuncture group,the drug group and the sham acupuncture group were increased by 19.6%,4.4%and 0.2%on average.The gray scale values of the left side plaques in the acupuncture group,the drug group and the sham acupuncture group were increased by 14.5%,22.9%and-3.2%on average.(3)Platelet aggregationIn terms of platelet aggregation rate,the average platelet aggregation rate in the acupuncture group before treatment was 56.38%,and the average platelet aggregation rate after treatment was 49.46%.There was a statistical difference between the two groups before and after treatment(P=0.011),which proved that acupuncture and moxibustion could reduce the rate of platelet aggregation.(4)FibrinogenIn terms of fibrinogen,the average fibrinogen was 3.51g/L in the acupuncture and moxibustion group before treatment,and 3.66g/L in the acupuncture and moxibustion group after treatment.There was statistically significant differences between the groups before and after treatment(P=0.100),demonstrating that acupuncture did not directly change plasma fibrinogen levels.(5)Apolipoprotein A-Ⅳ6 patients result is as follows:acupuncture group before treatment the blood of apolipoprotein A-Ⅳ 141.87ug/mL,168.96ug/mL after treatment.There was not statistically difference before and after the treatment(P=0.390),which prove that acupuncture can not change the blood level of apolipoprotein A-Ⅳ.(5)Platelet countIn terms of platelet count,the average platelet count in the acupuncture group was 237.06 before treatment and 241.69 after treatment.There was no statistically significant difference between the two groups before and after treatment(P=0.372),indicating that acupuncture did not directly change the number of platelets to play an anti-platelet aggregation role.(6)Blood lipidTriglycerides(TG)In terms of intra-group comparison,triglyceride levels before and after acupuncture treatment in the acupuncture group(P=0.886);Blood triglyceride level before and after treatment in the drug group(P=0.525);Blood triglyceride level before and after sham acupuncture treatment(P=0.132).In terms of comparison between groups,there was no statistical difference between groups before treatment(P=0.473),which was comparable.Repeated measurement anova showed no statistical difference between the three groups under different treatment methods(P=0.626).In terms of curative effect before and after treatment,the difference value of triglyceride was calculated(P=0.596).To sum up,the three groups of therapy did not improve the effect of triglyceride,and there was no significant difference in improving triglyceride.Total cholesterol(TC)In terms of intra-group comparison,total cholesterol level before and after acupuncture treatment in the acupuncture group(P=0.354);Blood total cholesterol level before and after treatment in drug group(P<0.01);Total blood cholesterol before and after sham acupuncture treatment(P=0.402).In terms of comparison between groups,there was no statistical difference between groups before treatment(P=0.586).Repeated measures anova showed no statistically significant difference in total cholesterol among the three groups under different treatments(P=0.558).In terms of efficacy before and after treatment,the difference in total cholesterol was calculated after the difference calculation(P<0.01).Pairwise comparison showed that there was a statistical difference between the drug group with the acupuncture group and the sham acupuncture group(P<0.01).To sum up,the drug group had some advantages in improving cholesterol,and there was no significant difference among the three groups in overall cholesterol change.High-density lipoprotein(HDL)In terms of intra-group comparison,high-density lipoprotein levels before and after acupuncture treatment in the acupuncture group(P=0.005);High-density lipoprotein levels before and after treatment in the drug group(P=0.580);High-density lipoprotein levels before and after sham acupuncture treatment(P=0.093).In terms of comparison between groups,there was no statistical difference between groups before treatment(P=0.956).Repeated measures anova showed that there was no statistically significant difference in HDL between the three groups under different treatment methods(P=0.103).In terms of curative effect comparison before and after treatment,there was no statistical difference in HDL between the two groups(P=0.075)after the difference calculation.To sum up,acupuncture and moxibustion has the effect of increasing HDL,and the overall efficacy is comparable among the three groups.Low density lipoprotein(LDL)In terms of intra-group comparison,low-density lipoprotein levels before and after acupuncture treatment in the acupuncture group(P=0.504);Low density lipoprotein levels before and after treatment in the drug group(P<0.01);Low density lipoprotein levels before and after sham acupuncture treatment(P=0.591).In terms of comparison between groups,there was no statistical difference in low-density lipoprotein(LDL)between groups before treatment(P=0.521).Repeated measures anova showed that there was no statistically significant difference among the three groups of LDL as a whole under different treatment methods(P=0.428).In terms of curative effect before and after treatment,low-density lipoprotein was statistically obtained after the difference calculation,and there was a statistical difference between the two groups(P=0.001).Pair comparisons showed that there was a statistical difference between the drug group with the acupuncture group and the sham acupuncture group(P<0.01,P=0.009),and there was no statistical difference between the acupuncture group and the sham acupuncture group(P=0.269).To sum up,acupuncture does not have the effect of reducing LDL,and its efficacy is not as good as that of the drug group.(7)Correlation analysisThe correlation analysis of the plaque volume changes before and after acupuncture treatment and the plaque GSM before treatment showed that the correlation coefficient r=-0.181 and P=0.251.Although there was a negative correlation trend,there was no statistical difference,proving that the plaque volume reduction did not change with the change of plaque hardness.(8)Shedding rateIn the acupuncture and moxibustion group,there were 2 cases of exfoliation,3 cases of exfoliation in the drug group,and 2 cases of exfoliation in the sham acupuncture group,with a total exfoliation rate of 7.78%.Conclusion1.Meta-analysis showed that acupuncture therapy or acupuncture combined with western medicine therapy was better than western medicine therapy in improving IMT,plaque thickness and plaque area;In TC,TG,LDL and HDL,the effect is similar.2.,Heart-Gallbladder Therapy "acupuncture can reduce the plaque volume and increase the gray scale value.The rate of plaque volume reduction is 18.2%,and the rate of gray scale increase on both sides is 19.6%and 14.5%.Acupuncture and aspirin combined with atorvastatin were equally effective,both better than sham acupuncture3."Heart-Gallbladder Therapy" acupuncture can prevent platelet aggregation,slow down the development of atherosclerotic plaques,and accelerate lipid metabolism by increasing HDL.Acupuncture has the effect of reducing and stabilizing plaques,which may be related to the elimination of lipid and nuclear components in plaques. |
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