| ObjectiveThree groups were divided by using a simple randomized controlled method,where three acupoints of breast(Rusanzhen)treatment combined with Nara moxibustion was used as the treatment group,three acupoints of breast treatment combined with massage and three acupoints of breast treatment combined with traditional Chinese medicine were used as the control group to compare the therapeutic effects of different methods for treating hyperplasia of mammary glands with liver stagnation and phlegm coagulation.In directly,this provide a basis for exploring a safer and more efficient clini.cal treatment plan for this disease.MethodsThe cases were collected from October 2017 to November ’2018 in the first affiliated hospital of Guangzhou University of Traditional Chinese Medicine,the acupuncture clinic and the breast department of outpatient clinic.There were 120 cases that met the criteria for inclusion of mammary glands hyperplasia.According to the ratio of 1:1:1,they were randomly divided into treatment group,control group 1 and control group 2,with 40 cases in each group.The treatment group was treated with three acupoints of’ breast teartment combined with Nara moxibustion.They were treated with acupuncture at first,with Danzhong,Rugen and Jianjing as the main acupoints,Shaoze,Hegu,Taichong and Fenglong as the matching acupoints.Those acupoints listed above were taken at both sides,after the acupoints get the qi,the manipulation of reinforcing and purging with the twisting methods were used.The manipulation will be taken once every 10 minutes,and the needle will be kept for 30 minutes.During the needle retention,Nara moxibustion treatment will be carried out,acupoints included Tianshu,Qihai and Zusanli will be selected about 45 minutes.Each acupoint in the first course and the second course treatment took 42℃(light yellow,soft type)and 45℃(yellow,mild type)Nara moxibustion respectively,to the degree with no burning skin sensation.The control group 1 was treated with acupuncture at first,and then manipulated with one-thumb massage,kneading,rubbing,pressing,grasping and other manipulations;the group 2 was treated with the oral administration of dredging meridians tablets will be given after the acupuncture was taken(Ingrediants:Centipede,Rhizoma cyperi,Rhizoma trigone,Zedoary turmeric,Rhizoma corydalis,etc).The acupuncture treatment for both control groups were same as the treatment group.The treatment time and course of these three groups:the Chinese medicine treatment is 4 tablets each time,3 times daily,taking after meals,1 month for 1 course of treatment,the next course of treatment will be continued after the stopping of the prescription for 7 days,a total of 2 courses for the treatment;the rest group of treatments should be avoided the menstrual period and ovulation period of the patients,manipulations were taken at the first to fifth days after the end of menstruation and the first to fifth days after the ovulation period of the patients,once a day,a total of 10 times per 1 menstrual cycle,1 menstrual cycle for a course of treatment,a total of 2 courses for the treatment.At the end of each treatment course,the efficacy statistics were conducted separately.Breast pain and breast lump are two main symptoms of mammary glands hyperplasia,hence,breast pain score and lump size score were the main efficacy evaluation indicators,while the changes of breast pain,hardness of lump,range of lump and size of lump were observed.The comprehensive efficacy of TCM systemic symptoms was used as the secondary efficacy evaluation indicators.The changes of serum estradiol(E2),progesterone(P)and prolactin(PRL)levels in the luteal phase of these three groups were measured as the objective evaluation indicators.Finally,according to the incidence of adverse reactions and recurrence rate of follow-up,the safety and long-term effects of each group were compared.All data of treatment results were analyzed by SPSS 22.0 software package.The measurement data were expressed as mean±standard deviation(x±s),and the enumeration data was expressed by composition ratio(%).If the normal di.stribution is not satisfied,it is described by M(P25,P75).According to α=0.05,P<0.05 is used as the significant level.Resuts1.Baseline levels were compared between these three groups before treatment.①age:After Kruskal-Wallis rank sum test,x2=1.930,.P=0.381>0.05,the difference was not statistically significant,and the three groups were considered to be equal in age and comparable in age.②course of disease:after one-way analysis of variance,F=0.481,P=0.619>0.05,the difference was not statistically significant,it can be considered that the three groups of patients have equal mean duration and comparable in disease duration.③main symptom scores:After Kruskal-Wallis rank sum test,comparison of three main symptom scores,P>0.05(x2＝1.343,p1＝0.511;x2=0.233,P2=0.890;x2=1.151,P3=0.562;x2=0.302,Pt=0.860),the difference was not statistically significant.It can be considered that the four main symptom scores of the three groups are equal,and the main symptoms are comparable.④ Hormone levels in the luteal phase:After one-way analysis of variance,the prolactin hormone levels were compared between the three groups,F=0.538,P=0.585>0.05,the difference was not statistically significant,and the prolactin hormone levels in the three groups were considered to be The numbers are equal and the three hormone levels are comparable.2.The comparison of main efficacy.① Before and after treatment in the treatment group:there were 38 patients in the treatment group,the main four symptoms(breast pain,hardness of the lump,range of the lump,size of the lump)were compared before and after the treatment.After the Wilcoxon signed rank sum test,T1=-4.307,T2=-4.896,T3=-5.196,T4=-5.466,P1、P2、P3、P4=0.000,Pare less than 0.01,the difference was statistically significant.It can be considered that the scores of the four main symptoms in the treatment group were significantly reduced after the treatment.②Before and after treatment in the control group 1:there were 36 patients in the control group 1,the four main symptom scores after the treatment were compared before and after the treatment.After the Wilcoxon signed rank sum test,Tl=-3,491,T2=-4。347,T3=-A.523,T4=-4.838,P1、P2、P3、P4=0.000,P are less than 0.01,the difference was statistically significant.It can be considered that the scores of the four main symptoms in the control group 1 were significantly reduced after the treatment.③Before and after treatment in the control group 2:there were 37 cases in the control group 2,the four main symptom scores after treatment were compared before and after the treatment.After the Wilcoxon signed rank sum test,T1=-3.309,T2=-4.873,T3=-5.296,T4=-5.260,P1＝0.001,P2、P3、P4=0.000,P are less than 0.01,the difference was statistically significant.It can be considered that the scores of the four main symptoms in the control group 2 were significantly reduced after the treatment.④The comparison of the scores between these three groups after treatment:the difference of breast pain symptom scores before and after treatment in the three groups,Kruskal-wallis rank sum test,x2=9.063,P=0.011<0.05,the difference was statistically significant,and the difference between the three groups was considered Breast pain symptom scores vary.According to the rank sum test of the pairwise comparison,the treatment group was compared with the control group 1 and the control group 2,P<0.05(H＝2.227,P=0.026;H＝2.857,P=0.004).The difference was statistically significant.It can be considered that the difference of the treatment group was larger than the control group 1 and the control group 2;the control group 1 was compared with the control group 2,H=0.606,P=0.545>0.05,the difference was not statistically significant.This shown that the difference between the control group 1 and the control group 2 was not yet considered to be differentThe differences in the scores of the stiffness scores of the three groups before and after treatment were compared by Kruskal-Wallis rank sum test,x2＝11.435,P=0.003<0.05.The difference was statistically significant.It can be considered that the scores of the stiffness scores of the masses in the three groups were different.According to the rank sum test of the pairwise comparison,the treatment group was compared with the control group 1 and the control group 2,P<0.05(H＝3.234,P=0.004;H=2.446,P=0.043).The difference was statistically significant It can be considered that the difference of treatment group was larger than the control group 1 and the control group 2;the control group 1 was compared with the control group 2,P>0.05(H=-0.800,P=1.000),the difference was not statistically significant.The difference between the control group 1 and the control group 2 could not be considered as different.The difference in symptom scores between the three groups before and after treatment was compared by Kruskal-wallis rank sum test,x2=6.567,P=0.038<0.05.The difference was statistically significant.It can be considered that the differences in symptom scores of the three groups were different.3.According to the rank sum test of the pairwise comparison,the treatmentthe group was compared with the control group 1,H=2.335,P=0.020<0.05,the difference was statistically significant.It can be considered that the difference of the treatment group was larger that the control group 1,the treatment group was compared with the control group 2 and the control group 1 was compared with the control group 2,P>0.05(H＝0.223,P=0.824;H=-2.100,P=0.107),the difference was not statistically significant.The difference between the treatment group with the control group 2 and the difference between the control group 1 with the control group 2 could not be considered in unequal.The scores of the tumor size scores before and after treatment in the three groups were compared by the Kruskal-Wallis rank sum test,x2=5.964,P=0.051>0.05.The difference was not statistically significant.It is not considered that the differences in the scores of the masses in the three groups were not equal.⑤The comparison of main efficacy of these three groups:the total effective rate of the treatment group was 63.16%;the total effective rate of the control group 1 was 38.89%;the total effective rate of the control group 2 was 32.43%.According to the Kruskal-Wallis rank sum test,x2＝9.137,P=0.010<0.05,the difference was statistically significant.According to the rank sum test of the pairwise comparisons,the treatment group was considered to be more effective than the control group 2(P<0.05),and the curative effect was better.There was no difference in efficacy between the compari son of treatment group with the control group 1,and the comparison between the control group 1 with the control group 2.3.Comparison of secondary effects.The total effective rate of the treatment group was 97.37%;the total effective rate of the control group 1 was 75.00%;the total effective rate of the control group 2 was 75.68%.After the Kruskal-Wallis rank sum test,x2=8.686,P=0.013<0.05,the difference was statistically significant.According to the rank sum test of the pairwise comparison,it can be considered that the treatment group was more effective than the control group 1(P<0.05),and the curative effect was better.There was no difference in efficacy between the treatment group with the control group 2 and the control group 1 with the control group 2.4.Comparison of objective indicators.① Comparison of estradiol level before and after treatment:The estradiol level before and after treatment in the treatment group was compared using the Wilcoxon signed rank sum test,T1=-4.764,P=0.000<0.01,the difference was statistically significant.It can be considered that the estradiol level after treatment was significantly lower than that before treatment;the estradiol level before and after treatment in the control group 1 was compared using the Wilcoxon signed rank sum test,T1=-4.545,P=0.000<0.01,the difference was statistically significant.It can be considered that the estradiol level after treatment is lower than before treatment;the estradiol level before and after treatment in the control group 2 was compared using the Wilcoxon signed rank sum test,T1=-5.273,P=0.000<0.01,the difference was statistically significant.It can be considered that the level of estradiol after treatment was considered to be significantly lower than that before treatment.The difference in estradiol level between these three groups before and after treatment was analyzed by analysis of the Kruskal-Wallis rank sum test,x2＝2.980,P=0.225>0.05.The difference was not statistically significant.The difference of estradiol level between these three groups before and after treatment could not be considered in unequal.②Comparison of progesterone level before and after treatment:the progesterone levels before and after treatment in the treatment group was compared using the Wilcoxon signed rank sum test,T1=-5.221,P=0.000<0.01,the difference was statistically significant.It can be considered that the progesterone level after treatment was considered to be higher than that before treatment;the progesterone level before and after treatment in the control group 1 was compared using the Wilcoxon signed rank sum test,T1＝-5.069,P=0.000<0.01,the difference was statistically significant.It can be considered that the progesterone level after treatment was higher than before treatment;the progesterone level before and after treatment in the control group 2 was compared using the Wilcoxon signed rank sum test,T1=-5.303,P=0.000<0.01,the difference was statistically significant.It can be considered that the progesterone level after treatment was considered to be higher than before treatment.The difference of progesterone level before and after treatment b.etween these three groups was analysed by analysis of the Kruskal-Wallis rank sum test,xZ=9.209,P=0.010<0.05,the difference was statistically significant.It can be considered that the difference in progesterone level between these three groups was different.4.According to the rank sum test of the pairwise comparison,the treatment group had larger difference in comparison with the control group 1(H=-2.942,P=0.010<0.05).There was no difference between the treatment group with the control group 2 and between the control group 1 with the control group 2(H=-2.082,P=0.112;11=0.848,P=1.000).③Comparison of prolactin level before and after treatment:the prolactin levels before and after treatment in the treatment group was compared using the paired t-test,t=6.032,P=0.00<0.01,the difference was statistically significant.It can be considered that the prolactin level after treatment was significantly lower than that before treatment;the prolactin level before and after treatment in the control group 1 was compared using the paired t-test,t=3.785,P=0.000<0.01,the difference was statistically significant.It can be considered that the prolactin level after treatment was lower than that before treatment;the prolactin level before and after treatment in the control group 2 was compared using the paired t-test,t=4.367,P=0.000<0.01,the difference was statistically significant.It can be considered that the prolactin level after treatment was lower than before treatment.After treatment,the prolactin levels were compared between these three groups.According to the one-way analysis of variance,F=1.888,P=0.156>0.05,the difference was not statistically significant.The difference of prolactin level between these three groups before and after treatment could not be considered in unequal.5.Safety evaluation.During the treatment,one case of needle fainting and one case of hematoma occurred in the treatment group;one case of hematoma and one case of needle retaining were observed in the control group 1,and two cases of hematoma and one case of needle retaining were observed in the control group 2.According to chi-square test,the incidence of adverse reactions in these three groups were compared,X2=0.308,P=0.896>0.05,the difference was not statistically significant.6.Comparison of Long-term efficacy.These three groups were followed up for one month after treatment.The recurrence rate of the treatment group was 20.83%;the recurrence rate of the control group 1 was 57.14%;the recurrence rate of the control group 2 was 58.33%.According to the chi-square test,the recurrence rate of these three groups was compared,x＝=7.068,P=0.033<0.05.According to the pairwise comparison,the recurrence rate of the treatment group was considered to be lower than that of the control group(P<0.05),and its long-term effect was better.There was no difference(P>0.05)between both control groups.Conclusion1.For the hyperplasia of mammary glands with liver stagnation and phlegm coagulation,the combination of three acupoints of breast treatment combined with Nara moxibustion,massage and traditional Chinese medicine can achieve the purpose of relieving breast pain and breast lumps.2.In comparison between these three groups of treatments,three acupoints of breast treatment combined with Nara moxibustion has better curative effect in relieving breast pain,lump size and its systemic symptoms.It acts better in regulating hormone levels in luteal phase and reducing recurrence rate.There is no significant difference between three acupoints of breast treatment combined with massage group and the three acupoints of breast treatment combined with traditional Chinese medicine group. |
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