Acupuncture Relieves The Efficacy Of Periodic Breast Pain - A Randomized Controlled Trial

Objective:To evaluate the effectiveness of acupuncture in relieving periodic mastodynia.Methods:46 patients were recruited and randomly assigned to acupuncture treatment group or sham acupuncture control group at a 1:1 ratio.In Acupuncture group,the following acupoints will be used:Rugen(ST 18),Wuyi(ST 15),Qimen(LR 14),Zusanli(ST 36),and Danzhong(CV 17).Among these acupoints,Rugen(ST 18),Wuyi(ST 15),Qimen(LR 14)was inserted at a depth of 12.5-20 mm horizontally or obliquely using 0.2*25mm Huatuo Brand needle twirling evenly until the Deqi and Keep needle for thirty minutes;Danzhong(CV 17)was inserted at a depth of 7.5-12.5mm horizontally using 0.2*25mm Huatuo Brand needle twirling evenly until the Deqi and Keep needle for thirty minutes;Zusanli(ST 36)was inserted at a depth of 25-40mm horizontally using 0.2*40mm Huatuo Brand needle twirling evenly until the Deqi and Keep needle for thirty minutes.In the sham acupuncture group,Outside the same acupuncture point 25mm was inserted 2.5mm without twirling using 0.2*25mm Huatuo Brand needle twirling shallowly and Keep needle for thirty minutes.The primary outcome was average change from baseline in breast pain(VAS-BP)during the treatment period:month1-3.The secondary outcome measures included:(1)average change from baseline in breast pain(VAS-BP)during the follow-up period:month4,month7;(2)The Short-Form McGrill Pain Questionnaire(SF-MPQ)score was evaluated with the change value of baseline in the treatment periodResults:46 female patients were included in this study.7 patients withdrew informed consent and 39 patients completed the trial.Sociodemographic characteristics and the clinical characteristics was consistent at baseline.The main outcome measures were VAS-BP compared with baseline changes during the treatment period:The acupuncture group was 31.66mm(95%CI 23.32,37.33).The sham acupuncture group was 30.33 mm(95%CI 23.32,37.33).The VAS scores of the average breast pain during the treatment period were statistically significant compared with baseline changes(P<0.05).The difference between the acupuncture group and the sham acupuncture group was 1.96 mm(95%CI 8.83,12.76).The difference was not statistically significant after treatment between the two groups(P>0.05).Changes in baseline SF-MPQ scores during treatment:The difference between the SF-MPQ score and the baseline change during the treatment period was 0.01,(95%CI-2.21,2.52).Compared with baseline,the acupuncture group was in the treatment period SF.-The MPQ score was reduced by 5.52 compared with baseline(95%CI 3.99,7.05);the sham acupuncture group had a 7.40 reduction in SF-MPQ score compared with baseline(95%CI 1.50,10.21).The SF-MPQ scores in the acupuncture group and the sham acupuncture group were significantly different from the baseline values(P<0.05).Compared between the acupuncture group and the sham acupuncture group,the average SF-MPQ scores at month1,month2,and month3 were not significantly different between the two groups(P>0.05).The difference in VAS scores from baseline in mean breast pain during follow-up was 37.58 mm(95%CI 33.71,41.45)in the acupuncture group and 37.3 mm(95%CI 32.1,42.50)in the sham acupuncture group.Statistically significant(P<0.05).The difference between groups was 1.41mm(95%CI 5.35,8.16);there was no significant difference between groups(P>0.05).The statistical results showed that there was a statistically significant difference in the mean VAS of breast pain between the two groups compared with baseline(P<0.05).There was no statistically significant difference between the two groups(P>0.05).Safety evaluation:There was no statistical difference between the acupuncture group and the sham acupuncture group in this study.Hemorrhage of a pinhole fter pulling out the needles in 1 participants of acupuncture group.The incidence of adverse events in acupuncture group was 4.5%and 0%in sham acupuncture group.No serious adverse events occurred in both groups.Conclusion:Acupuncture may alleviate cyclical breast pain.But it is not superior to sham acupuncture,which may be the reason of the small sample size.A randomized controlled trial with a larger sample size is needed to confirm the exact effect.