| Objective:To objectively evaluate the clinical efficacy and safety of "heart and gallbladder of TCM aspect" acupuncture theory in treatment of phlegm-damp carotid atherosclerosis,we randomly divided the patients with phlegm-damp carotid atherosclerosis into "heart and gallbladder of TCM aspect" acupuncture group and western medicine group by using carotid ultrasound and blood lipids as the evaluation.Method:A randomized controlled trial of 39 patients enrolled from the Traditional Chinese Medicine Hospital of Guangdong Province between May 2016 and February 2018 was used as research object.The patients were randomly divided into two groups according to the ratio of 2: 1 using PEMS3.2 software package "heart and gallbladder of TCM aspect" acupuncture group(acupuncture group)and western medicine group.Acupuncture group:Acupoints: Bilateral PC 6,GB 34,ST 9,BL 15,BL 17,BL 19 and unilateral GV 20,GV 28,CV 4,CV 6,CV 10,CV 12.Acupoint positioning with reference to the national general higher education "Eleventh Five-Year Plan" textbook "acupuncture."Operation:Select the acupoints such as GV 20,GV 28,PC 6,GB 34,ST 9,CV 4,CV 6,CV 10,CV 12,BL 17,BL 19 for acupuncture therapy.Tell patients flat lay and disinfect partial skin.Then use 0.30x25 mm particle type needle pierces into the skin and Slightly pull and twist it to get qi.Specially pay attention to operation of ST 9,must complete acupuncture in one step and don't try to extra pull and twist.Because of carotid artery under ST 9,need to avoid it.If succeed,the needle will swing with pulse.The whole process always lasts 30 minutes.After take of needles,needs to press both sides ST 9 in 2 minute individually.Select the acupoints such as CV 4,CV 6,CV 10,CV 12,BL 17,BL 19 for Jing-moxibustion(small-shape moxibustion)therapy.Tell patient take a seat,use a cotton swab dipped in a little scald oil gently applied to the skin,and then put 2x3mm(bottom diameter and high)cylindrical moxa on the skin.Then light top of moxa with incense sticks.When moxa left 1/2 or patient feel pain,remove moxibustion with tweezers.Do this operation 2 times in each treatment.Select the acupoints such as CV 6,CV 12 for Intradermal needle therapy.Intradermal needles can be left for 3 days.And tell patient take of them after 3 days.Western medicine group:Oral atorvastatin calcium 10 mg qn and aspirin enteric-coated tablets 100 mg qd.Treatment:The two groups were treated for 12 weeks.Acupuncture treatment 2 times a week,2 treatments interval of more than 72 hours,requiring at least 80% of the number of treatments completed.Evaluation time and indicators:The evaluation period of the curative effect was 12 weeks.The evaluation time points were 2 times before treatment and after treatment(12 weeks).Carotid ultrasound was the main evaluation index,and lipids were secondary evaluation indicators.Related indicators included: Intimamedia thickness(IMT),Crouse plaque integral,plaque volume,median gray value(GSM),total cholesterol(TC),Triglyceride(TG),High Density Lipoprotein(HDL-C),Low Density Lipoprotein(LDL-C),Lipoprotein a(Lp(a)).In addition,the properties of plaques before and after treatment were analyzed to compare the nature,length and thickness of the two groups before and after treatment.Statistics:Use spss 23.0 software for analysis.According to the different data types choose the appropriate statistical methods.The classification data using the chi-square test or accurate probability method,measurement data first normality test and homogeneity of variance test found that does not meet the normal distribution,so the comparison between groups were used Mann-Whitney rank sum test,the group were compared Wilcoxon rank sum test was used.Significant difference a = 0.05.Sample number:In this study,39 cases were enrolled,of which 26 were acupuncture group and 13 were western medicine group.Result:1.Baseline situation:Pre-treatment gender,occupation,education level,smoking,IMT type(normal or thickening)were compared with chi-square test or exactprobability comparison between the two groups,age,height,weight,BMI,systolic blood pressure at admission,and Measurements of diastolic blood pressure,IMT,Crouse plaque scores,plaque volume,GSM,TG,TC,LDL-C,HDL-C,Lp(a)and other measures were performed to compare the Mann-Whitney rank sum test.Excluding HDL-C,there was no significant difference between the two groups before treatment(P>0.05).The two groups can be considered comparable.2.IMT and IMT types(normal or abnormal)Intra-group comparison: There was a statistically significant difference in IMT between the acupunctur and moxibustion groups(bilateral IMT in the acupuncture group,left IMT,right IMT were P=0.000,P=0.007,P=0.014);acupuncture group IMT type,western medicine There was no significant difference in the IMT types between the western medicine group and the western medicine group(P>0.05).There was no significant difference in the left IMT difference and the right IMT difference before and after treatment between the acupuncture group and the western medicine group(P>0.05).Comparison between groups: There was a significant difference in the left IMT difference between the two groups before and after treatment(P=0.044).The acupuncture group was better than the western medicine group;the right IMT difference,the mean IMT difference was not statistically significant(P>0.05).>0.05).There was no significant difference in the number of normal IMT type,right IMT type,and IMT abnormal group after treatment in both groups(P>0.05).3.Crouse plaque scoreIntra-group comparison: The total Crouse plaque score before and after treatment in the acupuncture group,the left Crouse plaque score,the right Crouse plaque score,and the right Crouse plaque score before and after treatment in the Western medicine group were statistically significant(P = 0.000,respectively).P=0.000,P=0.022,P=0.042).There was no significant difference in total Crouse plaque score and left Crouse plaque score before and after treatment in Western medicine group(P>0.05).There was no significant difference between the left Crouse plaque scores and the right Crouse plaque scores before the treatment in the acupuncture group and the western medicine group(P>0.05),and the left Crouse plaque integration difference and the right Crouse plaque before and after the acupuncture group treatment.The differences of block integral difference were statistically significant(P=0.029).Left side improvement was better than right side.Western drug group had no difference between left Crouse plaque integral difference and right Crouse plaque integral difference before and after treatment.Significance(P>0.05).Between groups: There was no significant difference in the total Crouse plaque integral difference,the left Crouse plaque integral difference,and the right Crouse plaque integral difference between the two groups before and after treatment(P>0.05).4.Plaque volumeIntra-group comparison: There was a statistically significant difference in total plaque volume and left plaque volume before and after treatment in the acupuncture group,and there was a statistically significant difference in right plaque volume before and after treatment in the western medicine group(P = 0.017,P = 0.011,P,respectively).=0.031);There was no significant difference in the right plaque volume between the acupuncture group,the total plaque volume of the western medicine group,and the right plaque volume of the drug group(P>0.05).There was no significant difference in left and right plaque volume before and after treatment between the acupuncture group and western medicine group(P>0.05).Between-group comparisons: There was a statistically significant difference in left-sided plaque volume difference between the two groups before and after treatment(P=0.018).The acupuncture-moxibustion group was better than the western medicine group.There was no statistical difference in total plaque volume difference and right-side plaque volume difference.Significance(P>0.05).5.GSMWithin-group comparison: The average GSM(bilateral average),left GSM,and right GSM differences between the acupuncture group and the western medicine group before and after treatment were statistically significant(acupuncture group bilateral GSM,left GSM,right GSM were P= 0.009,P=0.016,P=0.018;Western medicine group bilateral GSM,left GSM,right GSM were P=0.001,P=0.003,P=0.005).There was no significant difference in left and right plaque volume before and after treatment between the acupuncture group and western medicine group(P>0.05).Between-group comparisons: There was no significant difference between the two groups in terms of bilateral GSM difference,left GSM difference,and right GSM difference(P>0.05).6.Blood lipids(TG,TC,HDL-C,LDL-C,Lp(a))The difference of TG,TC and LDL-C in the western medicine group was statistically significant before and after treatment(P=0.031,P=0.253,P=0.109,respectively);there was no significant difference in HDL-C and Lp(a)between the western medicine group and the treatment group(P>0.05),there was no significant difference in TG,TC,HDL-C,LDL-C and Lp(a)before and after acupuncture treatment(P>0.05).Comparison between groups: There was a significant difference in TC difference and LDL-C difference between the two groups before and after treatment(P=0.000,P=0.003,respectively).There was no significant difference in TG difference and Lp(a)difference.P>0.05).The difference in HDL-C between the two groups before treatment was statistically significant(P=0.032),so no difference in HDL-C difference was observed.7.Plaque condition(nature,length,thickness)Plasters were collected before treatment in the two groups,totaling 78 plaques.The nature,length,and thickness of each plaque were recorded and compared.Among them,21 were soft plaques in the acupuncture group,24 mixed plaques and 4 hard plaques;soft spots in the drug group.5,13 mixed plaques and 11 hard plaques.Intra-group comparison: There was no significant difference in plaque quality between the acupuncture group and the drug group before and after treatment(P>0.05).There was no significant difference in plaque quality between the two groups before treatment(P>0.05).Between groups: There was a statistically significant difference in plaque properties between the two groups(P=0.003).Therefore,the plaques were divided into three groups: soft plaque group,mixed plaque group and hard plaque group.Plaque length and plaque thickness before and after treatment in the two groups were different.Between and within groups.7.1 Soft spot groupIntragroup comparisons: There was a statistically significant difference in length and thickness of soft plaques before and after treatment in acupuncture groups(length and thickness were(P=0.000,P=0.000);there was no significant difference in length and thickness of soft plaques before and after treatment in Western medicine group(P).>0.05).Between groups: There was no significant difference in length and thickness of soft plaque between the two groups before and after treatment(P>0.05).7.2 Mixed groupIntra-group comparison: The length and thickness of the mixed plaques before and after treatment in the acupuncture group were statistically significant(P = 0.010,P = 0.006);the difference in mixed plaque thickness between the western medicine group and the treated group was statistically significant(P = 0.029).),The difference in length was not statistically significant(P>0.05).Comparison between groups: There was no significant difference in the length of mixed plaque between the two groups before and after treatment(P>0.05).The difference in plaque thickness between the two groups before treatment was statistically significant(P=0.029),so no difference was found in the difference in the mixed plaque thickness.7.3 Hard spot groupIntra-group comparison: There was no significant difference in the length and thickness of hard plaque before and after treatment in the acupuncture and moxibustion group(P>0.05).There was no significant difference in the length and thickness of hard plaque before and after treatment in the western medicine group(P>0.05).Between groups: There was no significant difference in the length and thickness of plaque between the two groups before and after treatment(P>0.05).8.Security Evaluation:The acupuncture-related adverse events in the acupuncture group mainly included local hematoma and local blisters,which could be relieved within 1 week.They were explained to the subjects and did not affect the trials.Western medicine group did not appear any adverse reactions.Conclusion:1.Acupuncture based on The “heart and gallbladder of TCM aspect” can effectively improve IMT,Crouse plaque integral,plaque volume,GSM,Western medicine plan of patients with phlegm and carotid atherosclerosis can effectively improve Crouse plaque in patients with phlegm and carotid atherosclerosis.Block integral,plaque size,GSM and blood lipid indexes including TC,LDL-C,acupuncture and moxibustion are better than Western medicine in improving the evaluation index of color Doppler ultrasound.Western medicine is better than acupuncture and moxibustion in improving blood lipids.2.Acupuncture based on The “heart and gallbladder of TCM aspect”on the left side carotid artery atherosclerosis is better than the right side,and the degree of atherosclerosis on the left side of the carotid artery is better than the Western medicine.3.Acupuncture based on The “heart and gallbladder of TCM aspect” and medicine both can effectively treat plaques containing lipid cores. |
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