| OBJECTIVETo observe and evaluate the efficacy and safety of acupuncture in relieving moderate to severe cyclical breast pain.METHODSProspective,randomized,two-group parallel control methods were used.Patients who met the inclusion criteria were randomly assigned to the experimental group(acupuncture group)and the control group(placebo group).The selected acupuncture points in the acupuncture group were,danzhong(CV 17),rugen(ST 18),wuyi(ST 15),qimen(LR 14),zusanli(ST 36)and sanyinjiao(SP 6).There were 10 menstrual cycles in the study,including1 menstrual self-collection in the baseline period,3 menstrual cycles in the treatment period,and 6 menstrual cycles in the follow-up period.Both groups received treatment 3 times a week for 30 minutes each in the two weeks prior to menstruation,and received treatment for 3 consecutive menstrual cycles for a total of 18 times.The primary outcome index of this study was the effective rate of breast pain relief in the third menstrual cycle,that is,the percentage of the subjects whose total breast pain VAS score was reduced by 50%or more compared with the baselineSecondary outcome indicators included changes in overall breast pain VAS score from baseline,average daily breast pain VAS score in luteal phase,breast pain symptoms and health-related quality of life questionnaire(bp-qol)score,overall recovery self-assessment of Likert patients and adverse reactionsRESULTIn this study,a total of 50 patients with recurrent breast pain were included,including 3 patients who withdrew informed consent at the baseline observation period,6 patients who lost their consent,22 patients in the acupuncture group and 19 patients in the control group.Primary outcome measures:percentage of subjects treated for 3rd menstrual cycle with a 50%or greater reduction in total breast pain visual analogue score from baseline.Results:the response rate of the experimental group was 72.72%(16/22),and that of the control group was 42.1 1%(8/19).The difference between the two groups was statistically significant(P=0.047<0.05).Secondary outcome indicators:(1)the number of remission cases and remission efficiency of total breast pain in the 2nd menstrual cycle,the 6th menstrual cycle and the 9th menstrual cycle,respectively,in the experimental group,8(8/22,36.36%),13(13/20,65%and.8(8/16,50%).The control group was 7 cases(7/22,36.84%),6 cases(6/20,35.29%)and 4 cases(4/12,33.33%),respectively.There was no statistical difference between the two groups(P>0.05).(2)after the treatment of the second menstrual cycle,the total breast pain VAS score of the subjects in the 6th and 9th menstrual cycles during the follow-up period was-24.05±15.04,-28.20±24.55,-25.18±21.63 in the experimental group,and-19.32±15.58,-23.06110.58,-24.22±17.63 in the control group.The differences between the two groups were-3.43(-12.02,5.17),-3.91(-16.41,8.58),and-2.35(-17.42,12.72),respectively.There were statistical differences in the comparison between the two groups(P<0.05),and no statistical differences in the comparison between the two groups(P>0.05).In the third menstrual cycle,the difference between the two groups was-8.74(-17.47,-0.28),with statistically significant differences(P<0.05).(3)the proportion of subjects whose average daily mammary pain VAS score in the second and third menstrual cycle of treatment period decreased>50%from the baseline was 11(50%)and 15(68.18%)in the experimental group,and 6(3 1.58%)and 7(36.84%)in the control group,respectively.After the treatment of 2 menstrual cycles,the comparison between the two groups was not statistically significant(P>0.05).After 3 menstrual cycles,the ratio of the two groups was statistically significant(P=0.045<0.05).(4)the average daily mammary pain VAS score in luteal stage of subjects in the second menstrual cycle showed statistical difference between the two groups(P<0.05),but no statistical difference between the two groups(P>0.05).In the treatment of the 3rd menstrual cycle,there were statistically significant differences between the two groups(P<0.05).(5)the BP QOL scale score of the menstrual cycle in the second and third days of treatment and the follow-up period in the sixth and 9th days of the menstrual cycle was 66.80±16.63,69.32+16.33,68.59±15.97,67.19±16.39 in the experimental group,and 65.96±11.92,67.62+1 1.63,67.84±10.89,65.22115.10 in the control group.The difference between the two groups was 0.84(-8.44,10.12),1.70(-7.40,10.79),and 0.75(-8.54,10.04),1.97(-10.48,14.42),treatment of the second menstrual cycle,the first two groups after 3 menstrual cycle BP-QOL scores were statistically compared with baseline(P<0.05),followed up for the first 6 menstrual cycle,follow-up 9 menstrual cycle,two groups were no statistical difference compared to the baseline(>0.05),all had no statistical difference between the two way to visit viewpoint;(6)for the treatment of the second and third menstrual cycles,there was no statistical difference between the two groups for the treatment of the second menstrual cycle(P>0.05),and there was a statistical difference between the two groups for the treatment of the third menstrual cycle(P=0.021).(7)in terms of safety evaluation,serious adverse events occurred in both groups.The incidence of adverse events in the test group was 12.50%,and that in the control group was 4.35%.Upon examination,there was no statistical difference in the incidence of adverse events between the two groups(P>0.05).CONCLUSIONCompared with simulated acupuncture,acupuncture can alleviate the pain of patients with moderate and cyclical severe breast pain during treatment,especially the breast pain in the late luteal period,with higher safety.However,after discontinuation of treatment,the long-term effect of acupuncture group was not better than that of the simulated acupuncture group,and the pain relief effect may not be maintained for 3 months or longer.The sample size of this trial is small,so there may be some bias.Interpretation should be cautious,and the efficacy of acupuncture in alleviating cyclical breast pain still needs to be studied with a larger sample size. |
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