| ObjectivesTo compare the efficacy between manual acupuncture(MA)and transcutaneous electrical nerve stimulation(TENS)in relieving the pain of primary dysmenorrhea(PD).MethodsThis study was conducted by prospective,randomized,two-group parallel contro1.49 participants with primary dysmenorrhea were enrolled and randomly allocated to MA group or TENS group.MA group chose Shiqizhui(EX-B7),Ciliao(BL32),Diji(SP8),Sanyinjiao(SP6).TENS group applied transcutaneous electrical nerve stimulation with high frequency.The location of electrodes was over the lower back and along the lower borders of the ribs and the upper borders of the hip crests on both sides.The duration of this study was 7 menstrual cycles,including a 1-menstrual cycle baseline assessment,3-menstrual cycle treatment period and 3-menstrual cycle follow-up period.Participants in both groups were treated on the first day of menstrual pain,once a day for three continuous days.The treatment was required for 3 menstrual cycles.The primary outcome was the percentage of participants with reduction of mean pain by at least 50%at the third menstrual cycle.The secondary outcomes included the changes in mean pain intensity,worst pain intensity,duration of pain,the Cox Menstrual Symptom Scale,the days between two menstruation cycles,the days during the menstruation at the first,second,third,and sixth menstruation cycles.ResultsA total of 49 patients with primary dysmenorrhea were included in this study.17 patients in the MA group and 20 patients in the TENS group completed the treatment.The primary outcome was the percentage of participants with reduction of mean pain by at least 50%at the third menstrual cycle.The MA group were 35%(6 patients)and the TENS group were 45%(9 patients).There was no statistical difference between the two groups(P=0.549).The secondary outcomes:1.The percentage of participants with reduction of mean pain by at least 50%at the first,second and sixth menstruation cycles.The number and percentage in the MA group were 1(15.26%),3(17.65%),5(50%)respectively,and in the TENS group were 2(9.52%),5(25%),9(69.23%)respectively.There was no statistical difference between the two groups(P=0.609;P=0.588;P=0.349).2.The changes in mean pain intensity(NRS)compared with baseline.The NRS reduced 1.05±1.61,1.76±1.75,2(3.5),3.4±2.01 respectively in MA group and decreased 1(2),2.25±1.8,2.85±1.9,3.15±1.63 respectively in TENS group at the first,second,third and sixth menstruation cycles.There was statistical difference in both groups(MA group:P=0.012;P=0.002;P<0.001;P=0.005.TENS group:P=0.006;P<0.001;P<0.001;P=0.002)while no statistical difference between the two groups(P=0.901;P=0.414;P=0.988;P=0.748).3.The changes in worst pain intensity(NRS)compared with baseline.The NRS reduced 0(2),1(4),2(3),3.5±2.27 respectively in MA group and decreased 1(2),2.25±2.05,3.05±2.31,3.08±2.72 respectively in TENS group at the first,second,third,sixth menstruation cycles.There was statistical difference in both groups(MA group:P=0.046;P=0.003;P<0.001;P=0.001.TENS group:P=0.005;P=0.001;P<0.001;P=0.007)while no statistical difference between the two groups(P=0.501;P=0.734;P=0.815;P=0.696).4.The changes in duration of pain compared with baseline.The number of days with pain reduced-0.13±1.03,0.68±1.04,0.62±1.11,1(0.38)respectively in MA group and decreased 0(1.5),0.26±1.02,0.48±1.06,0.5(1)respectively in TENS group at the first,second,third,sixth menstruation cycles.There was statistical difference in MA group at the second,third and sixth menstruation cycles(P=0.023;P=0.046;P=0.021).There was no statistical difference between the two groups(P=0.500;P=0.246;P=0.692;P=0.059).5.The changes in severity of menstrual symptoms(CMSS)compared with baseline.The score reduced 3.42 ± 8.49,6.41 ± 10.34,9.41 ± 6.98,5.9 ± 7.56 respectively in MA group and decreased 4.62±3.63,5.75±7.59,6.1 ±9.38,7.46±7.13 respectively in TENS group at the first,second,third,sixth menstruation cycles.There was statistical difference in MA group at the second,third,sixth menstruation cycles and in TENS group at the first,second,third,sixth menstruation cycles(MA group:P=0.021;P<0.001;P=0.036;TENS group:P<0.001;P=0.005;P=0.008;P=0.008).There was no statistical difference between the two groups(P=0.574;P=0.824;P=0.238;P=0.617).6.The changes in duration of menstrual symptoms(CMSS)compared with baseline.The score reduced 3.05 ± 8.3,6.65±7.94,11.35±9.01,8.4±10.74 respectively in MA group and decreased 7.67±5.53,9.6±8.95,10.25±9.11,7(14)respectively in TENS group at the first,second,third,sixth menstruation cycles.There was statistical difference in MA group at the second,third,sixth menstruation cycles and in TENS group at the first,second,third,sixth menstruation cycles(MA group:P=0.003;P<0.001;P=0.035;TENS group:P<0.001;P<0.001;P<0.001;P=0.002).There was no statistical difference between the two groups at the second,third and sixth menstruation cycles(P=0.271;P=0.715;P=0.877).7.The changes in the days between two menstruation cycles compared with baseline.There was no statistical difference in both groups(MA group:P=0.074;P=0.811;P=0.244;P=0.207;TENS group:P=0.252;P=0.157;P=0.548;P=0.291)and no statistical difference between the two groups(P=0.783;P=0.269;P=0.734;P=0.724).The changes in the days during the menstruation compared with baseline.There was no statistical difference in MA group at the first,second,third,sixth menstruation cycles and in TENS group at the first,second,third menstruation cycles(MA group:P=0.655;P=0.414;P=0.414;P=1;TENS group:P=0.366;P=0.582;P=0.327).There was no statistical difference between the two groups(P=0.556;P=0.850;P=0.769;P=0.056).The incidence of adverse events was 4%in MA group and 0%in TENS group.There was no statistical difference between the two groups(P=0302).ConclusionsBoth MA and TENS can reduce the pain of primary dysmenorrhea effectively and safely.The efficacy of MA in the relief of primary dysmenorrhea is not better than TENS.There was no significant difference in the efficacy of the two therapies in the short term and long term. |
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