| ObjectiveOn the basis of three-step analgesic drugs,the clinical efficacy and safety of acupuncture in improving mild and moderate cancer pain in breast cancer patients were evaluated by compari ng acupuncture wi th sham acupuncture.MethodsThe research adopts Randomized controlled trial.All the subjects come from the Guangdong Province TCM Hospital,divided into acupuncture group(30 cases)and sham acupuncture group(30 cases)on average by the SPSS 20.0 package.(1)Intervention programs①Basic treatment:Acupuncture group and sham acupuncture group all use three steps analgesic drug therapy as basic treatment.The first step uses non-steroidal anti-inflammatory drugs Celecoxib Capsules,with the dose of 200mg.The second step uses weak opioids(Tramadol Hydrochloride Sustained Release Tablets),with the dose of 100mg.All the drugs are taken once every twelve hours.②Acupuncture treatment Acupuncture group:Acpoint:KongZui(double),LiangQiu(double),ZhongDu(double);Acupuncture destination:refer to<nomenclature and location of acupuncture points>which is the National standards of the People’ s Republic of China published in 2006(GB/T12346-2006).OperationPatients in supine position,performer disinfected the finger and skin with the 0.5%Anerdian,the needle was inserted rapidly,and the twist manipulation was performed until the patient felt local acid and numbness,and the twist manipulation was performed once each 10 minutes.Leave the needle for 30 minutes.Sham acupuncture group:Acpoint the same as the acupuncture group.Patients were placed in a supine position,and a sticky foam needle pad on the back was placed on the corresponding acupoints.The flat head needle was used to pass through the foam needle pad and keep the patient upright,without penetrating the skin,so that the patient would have a certain sense.Produce a slight sensation of irritation.No need to get air,no need to perform manipulation,leave the needle for 30min.When pulling out the needle,first remove the flat head needle and then tear off the foam pad.(2)Treatment and frequency:In this study,there were two courses of treatment,each course was 10 days,and the treatment frequency was 1 time per day for a total of 20 days.(3)Evaluation point and indicatorsBefore the treatment,after the tenth treatment,at the end of the course,using the Numerical rating scale(NRS),short form McGill pain rating scale(SF-MPQ),Tumor quality of life assessment(QLQ12)to evaluate the curative effect between the two groups.(4)StatisticalCases of the collected information,SPSS20.0 statistical software package is adopted to establish the database,makes clear the check data and statistical analysis of clinical trial data properties(classification of measurement data and information),select the appropriate statistical analysis method for classifying data by chi-square test or the exact probability method,hierarchical data comparing samples of Wilcoxon rank and inspection(calibration)or more groups of comparative Kruskal-Wallis test measurement data to normality test and f test,meet the requirement use independent sample t-test,paired t test was used for intra-group comparison;If the variance of the normal distribution is inconsistent,the rank sum test is used,and the mean rank sum quartile and median are used to represent the quantitative outcome index of multiple time points.The repeated measurement of variance is used,and the Mauchly test of sphericity is corrected by the coefficient.Results1、BaselineComparison of baseline before treatment between acupuncture group and sham acupuncture group,in the age(P=0.873),course of disease(P=0.253),degree of education(P=0.626),syndrome difference of traditional Chinese medicine(P=0.725),Numerical rating scale(NRS)(P=0.724)/short form McGill pain rating scale(SF-MPQ)(P=0.602)、Tumor quality of life assessment(QLQ12)(P=0.664)were no obvious difference.2、Numerical rating scale(NRS)scoreAt the end of treatment,the NRS score of both groups decreased compared with that before treatment.Intra-group comparison:there was a statistical difference in scores between the before of the treatment and the 10th treatment at the acupuncture group(P<0.05),and a statistical difference in scores between the before of the treatment and the 10th treatment at the sham acupuncture group(P<0.05).Comparison between groups:there was a statistical difference in scores between acupuncture group and sham acupuncture group at the 10th treatment(P<0.01),and a statistical difference between acupuncture group and sham acupuncture group at the end of treatment(P<0.01).The repeated measurement anova of acupuncture group and sham acupuncture group showed a statistical difference in time dimension(P<0.01),a statistical difference between groups(P<0.05),and a statistical difference after the interaction between time and groups(P<0.01).The results showed that the acupuncture group and sham acupuncture group had improvement in NRS evaluation.The curative effect of acupuncture group was better than that of sham acupuncture group.3、Short form McGill pain rating scale(SF-MPQ)scoreAt the end of the two groups of patients in the treatment of Short form McGill pain rating scale(SF-MPQ)score before treatment were falling.Intra-group comparison:there was a statistical difference in scores between the before of the treatment and the 10th treatment at the acupuncture group(P<0.05),and a statistical difference in scores between the before of the treatment and the 10th treatment at the sham acupuncture group(P<0.05).Comparison between groups:there was a statistical difference in scores between acupuncture group and sham acupuncture group at the 10th treatment(P<0.01),and a statistical difference between acupuncture group and sham acupuncture group at the end of treatment(P<0.01).The repeated measurement anova of acupuncture group and sham acupuncture group showed a statistical difference in time dimension(P<0.01),a statistical difference between groups(P<0.05),and a statistical difference after the interaction between time and groups(P<0.01).The results showed that the acupuncture group and sham acupuncture group had significant improvement in SF-MPQ evaluation.The curative effect of acupuncture group was better than that of sham acupuncture group.4、Tumor quality of life assessment(QLQ12)At the end of treatment,QLQ12 scores of patients in both groups increased compared with those before treatment.Intra-group comparison:there was a statistical difference in scores between the before of the treatment and the 10th treatment at the acupuncture group(P<0.05),and a statistical difference in scores between the before of the treatment and the 10th treatment at the sham acupuncture group(P<0.05).Comparison between groups:there was a statistical difference in scores between acupuncture group and sham acupuncture group at the 10th treatment(P<0.01),and a statistical difference between acupuncture group and sham acupuncture group at the end of treatment(P<0.01).The repeated measurement anova of acupuncture group and sham acupuncture group showed a statistical difference in time dimension(P<0.01),a statistical difference between groups(P<0.01),and a statistical difference after the interaction between time and groups(P<0.01).The results showed that the acupuncture group and sham acupuncture group had significant improvement in the evaluation of tumor quality of life.The curative effect of acupuncture group was better than that of sham acupuncture group.5、Treatment efficiency comparisonThe effective rate of treatment was evaluated by the NRS score,and the effective rate of reduction was calculated by the nimodinine method,which was 93.1%in the acupuncture group and 53.6%in the sham acupuncture group.The difference between the two groups was significant(P<0.01),and the efficacy of the acupuncture group was better than that of the sham acupuncture group.6、Adverse reactionsThere were 2 cases of nausea and vomiting in acupuncture group,1 case of dry mouth constipation,4 cases of nausea and vomiting and dry mouth in sham acupuncture group,2 cases of constipation and 1 case of insomnia.All of them were side effects of analgesic drugs,so they were continued after symptomatic treatment.During the treatment,no acupuncture adverse events such as delayed needle,bending needle,breaking needle,bleeding and hematoma were observed in the subjects of the two groups.No serious adverse reactions were observed in the two groups.Conclusion1.Acupuncture combined with three steps analgesic drug,sham acupuncture combined with three steps analgesic drug are effective in improving mild and moderate cancer pain of breast cancer and the life quality of patients,and acupuncture combined with three steps analgesic drug is more effective.2.Acupuncture treatment itself can improve the quality of life and pain of mild and moderate breast cancer. |
