Efficacy Of Electroacupuncture Relative To Transcutaneous Electrical Acupoint Stimulation For The Treatment Of Severe Chronic Constipation

ObjectivesTo observe the efficacy and safety of electroacupuncture(EA)relative to transcutaneous electrical acupoint stimulation(TEAS)for the treatment of severe chronic constipation.MethodsThis is a randomized parallel-group controlled trial.70 participants with severe chronic constipation were enrolled and randomly allocated to EA group or TEAS group.The acupoints in both groups are bilateral Tianshu(ST[stomach]25),Fujie (SP[spleen]14),and Shangjuxu(ST37).They were treated with EA or TEAS respectively.The study period was 33 weeks,including a 1-week baseline assessment,8-week treatment period and 24-week follow-up period.Participants in both groups were treated for 30 minutes each time and 3 times per week for 8 weeks.The primary outcome is the percentage of participants with an average increase from baseline of one or more complete spontaneous bowel movements(CSBMs)at week 8.The secondary outcome measures included number and changes in the number of CSBMs,and spontaneous bowel movements(SBMs),stool character,difficulty in defecation,patient assessment of constipation quality of life(PAC-QOL),use of auxiliary defecation methods,and adverse reactions.ResultsA total of 70 eligible participants were included.34 participants in the EA group and 31 participants in the TEAS group completed the treatment.The primary outcome is the percentage of participants with an average increase from baseline of one or more CSBMs at week 8.There were 31 cases in the EA group,accouting for 88.57%,and 25 cases in the TEAS group,accouting for 71.43%.There was no significant difference between the two groups(P=0.133).The secondary outcomes:1.At weeks 4,20,and 32,the percentage of participants with an average increase from baseline of one or more CSBMs.The number and percentage in the EA group were 21(60.00%),23(82.14%)and 14(63.64%)respectively,and in the TEAS group were 23(65.71%),10(35.71%)and 8(34.78%)respectively.There was statistical significance between the two groups at week 20(P=0.001)while no statistical difference at week 4(P=0.805)and 32(P=0.076).2.At weeks 4,8,20,and 32,the percentage of participants with 3 or more CSBMs.The number and percentage in the EA group were 18(48.57%),24(68.57%),19(37.86%)and 12(54.55%)respectively,and in the TEAS group were 10(28.57%),14(40.00%),6(21.43%)and 5(21.74%)respectively There was statistical significance between the two groups at week 8(P=0.030),week 20(P=O.001)and week 32(P=0.033)while no statistical difference at week 4(P=0.087).3.Change in the number of CSBMs at weeks 4,8,20,and 32.Compared with the baseline,the number of CSBMs were increased by 1(3),3(3),2.50(3),2(4)in the EA group and 1(2),1.84(3),0(2),0(2)in the TEAS group.There was significant statistical significance in both groups(P<0.01).There was statistical significance at weeks 8(P=0.038),20(P=0.001),and 32(P=0.038)between the two groups,but no significant difference in the 4th week(P=0.746).4.Change in the number of SBMs at weeks 4,8,20,and 32.Compared with the baseline,the number of SBMs were increased by 1.82 ± 1.89,2(2),2(3),1.41 ± 1.97in the EA group and 1(2),1(3),0.88(2),0.76± 1.68 in the TEAS group.There was statistical significance in both groups(P<0.05).There was statistical significance at week 20(P=0.030)between the two groups,but no significant difference at weeks 4(P=0.097),8(P=0.266),and 32(P=0.262).5.At week 8,the stool traits of spontaneous defecation were increased by 0.37±1.03 in the EA group and 0.60(0.93)in the TEAS group.There was statistical significance in both groups(P=0.048,P=0.001)while no statistical difference between the groups(P=0.073).6.The percentage of cases with type 3 to 4 stool traits in the EA group were 25.71%,25.71%,42.86%,27.27%respectively,and in the TEAS group were 28.57%,28.57%,28.57%,17.39%respectively.There was no statistical significance between the groups at week4(P=1.000),week8(P=1.000),week20(P=0.403)and week 32(P=0.491).7.There was statistical significance in the degree of defecation difficulty in both groups compared with the baseline,but no statistical difference between the two groups at week4(P=0.614),week8(P=0.076),week20 (P=0.054)and week 32(P=0.116).8.After 8 weeks treatment,the score of PAC-QOL scale in the EA group was 66.79±19.62,which was 19.06±14.19 lower than the baseline,and 72.26±15.30 in the TEAS group,decreased by 12.48±8.58.There was significant statistical difference in both groups(P<0.01)and between the two groups (P=0.009).9.There was no statistical difference in the number of applications and cases of assisted defecation methods in both groups and between the two groups at the time of visit(P>0.05).10.Safety evaluation of two groups during the course of treatment.There were no serious adverse events in the two groups.The incidence of adverse events was 5.71%in the EA group and 2.86%in the TEAS group.There was no significant difference in the incidence of adverse events between the two groups by Chi-square test(P=1.000).ConclusionsThe efficacy of EA in the treatment of severe chronic constipation is not superior to TEAS,but both of them can increase the number of CSBMs and SBMs,improve stool traits,reduce the degree of defecation difficulty.The curative effect can last for 24 weeks without serious adverse events.At the same time,both therapies can improve patients' quality of life.Although EA is superior to TEAS in improving the quality of life,TEAS can be a better choice for patients with severe chronic constipation fearing of acupuncture because it is non-invasive.But the comparison of efficacy between EA and TEAS for the treatment of severe chronic constipation still needs to be further studied in large samples.