中药穴位贴敷辅助治疗乳腺增生多中心随机双盲安慰剂对照研究OA北大核心CSTPCD

Objective To observe the clinical efficacy of acupoint application of Chinese herbs(CHs)on mammary hyperplasia(MH)in improving breast pain and Chinese medical syndrome scores(CMSS),elevating patients'quality of life(QOL),and its effect on inflammatory factors.Methods A total of 148 patients in line with the inclusion criteria were placed into an opaque sealed envelope in a numerically generated sequence,and then assigned to the experimental group(Xiaozhong Zhitong Plaster+CHs powder)and the control group(Xiaozhong Zhitong Plaster placebo+CHs powder placebo)according to random digit ratio of 1∶1,74 cases in each group.Ashi point(bilateral),Yongquan point(KI1,bilateral),and Shenque point(RN8)were applied every other day for 6～8 h each time.CHs acupoints were applied at armpit 10 points(bilateral)for 30 min each time.The treatment lasted for 8 weeks.Changes of breast pain Visual Analogue Score(VAS),CMSS,Self-rated Anxiety Scale(SAS)score,Hamilton Depression(HAMD)score,QOL score(SF-36),and serum levels of 5-hydroxy tryptamine(5-HT),brain-derived neurotrophic factor(BDNF),IL-6,and tumor necrosis factor-α(TNF-α)were compared between the two groups before and after treatment.Results After 8 weeks of treatment,the scores of breast pain and breast tenderness(VAS)were significantly lower in the experimental group than in the control group(t1=-7.262,t2=-6.914,P＜0.01),and the average onset time was shorter in the experimental group than in control group[(8.81±4.06)days vs.(12.59±6.90)days;t=-4.029,P＜0.01).CMSS,SAS score,and HAMD score were lower,and SF-36 score was higher in the experimental group than those in the control group(t1=-6.882,t2=-2.537,t3=-2.864,t4=3.241,P＜0.01).IL-6 and TNF-α were lower,and 5-HT and BDNF were higher in the experimental group than in the control group(t1=-3.155,t2=-2.963,t3=2.051,t4=6.631,P＜0.05,P＜0.01).Conclusion Xiaozhong Zhitong Plaster combined with CHs powder acupoint application alleviated breast pain,improved immune environment,anxiety and depression,and elevated QOL.(Chinese Clinical Trial Registry No.Chi CTR 2200056568)