The Efficacy Of Electroacupuncture In Relieving The Symptoms Of Mild To Moderate Pelvic Organ Prolapse In Wome

Objective:To explore the efficacy of electroacupuncture in relieving the symptoms of mild to moderate(degrees-Ⅱ,-Ⅲ)pelvic organ prolapse(Pelvic Organ Prolapse,POP)in women,and to evaluate the safety of electroacupuncture scheme.Methods:In this study,a double-arm,prospective,block random design was adopted,and the random numbers and random groups were hidden by opaque sealed envelopes.Group A was assigned as electroacupuncture group and group B as sham Electroacupuncture group.The patients of the two groups were randomly assigned to group A and group B according to the proportion of 1:1.The 60 patients in the trial were numbered according to the order of enrollment,and the corresponding sealed envelopes were opened to get the random distribution groups corresponding to the inclusion order.In the electroacupuncture group,patients took acupoints of Zhongliao(BL33),Huiyang(BL35)and Sanyinjiao(SP6)on both sides.Zhongliao(BL33)were obliquely needled inward and downward about 45°60°into the third posterior sacral foramen.After the doctors had a breakthrough and a sense of tightness,the acupuncture depth was about 60 mm-70 mm.Huiyang(BL35)was inserted into the lateral edge of the coccyx,slightly outward and upward oblique needling 60 mm-70 mm,and Sanyinjiao(SP6)was punctured directly into 25 mm-30 mm.After the acupuncture was inserted into the three acupoints,all the needles were lifted and twisted uniformly for 3 times,taking the feeling of de qi caused by local sore numbness and distension of the patient as the degree.After acupuncture,two electrodes of the electroacupuncture instrument were connected in both sides of Zhongliao(BL33),Huiyang(BL35)and Sanyinjiao(SP6),respectively.The electroacupuncture instrument was set to continuous wave,frequency 20Hz,the current intensity of Zhongliao(BL33)and Huiyang(BL35)was 2 mA-6.5 mA,and Sanyinjiao(SP6)was 1 mA-3.5 mA.During the operation,the current intensity was gradually increased from 0 to the degree of patient tolerance.In the sham Electroacupuncture group,Zhongliao(BL33)and Huiyang(BL35)were 1 cun outward horizontally,and Sanyinjiao(SP6)was the midpoint of the horizontal line between bilateral and Achilles tendon with 1.5cun needle inserted into 2 mm-3 mm until the needle was straight,no manipulation and without de qi.After the completion of acupuncture,the electrode connection method was the same as that of electroacupuncture group.Electroacupuncture instrument is set to continuous wave,frequency 20 Hz,short output weak current until the patient perceives a slight electrical stimulation(usually 0.1 mA-0.3 mA),about 30 seconds,turn off the power.Patients in both groups retained needles for 30 minutes each time,3 times a week in the first 4 weeks,2 times a week in the middle 4 weeks,and once a week in the last 4 weeks.There were a total of 12 weeks(3 months)of treatment,that is,24 treatments.The study continued 9 months,of which the baseline period was 1 week(week 0),the treatment period was 3 months,and the follow-up period was 6 months after treatment.The main outcome index of this study was the changes of the Pelvic Floor Distress Inventory-20(PFDI-20)between the baseline and the end of 3 months of treatment.The secondary outcome indicators was the changes of the Pelvic Floor Distress Inventory-20(PFDI-20)between the baseline and 6 and 9 months after randomization;and the Pelvic Floor Impact Questionnaire Short Form-7(PFIQ-7)compared with the baseline changes after treatment and follow-up.The changes of the International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form(ICIQ-SF)and pelvic organ prolapse and the pelvic organ prolapse/urinary incontinence sexual questionnaire(PISQ-12)after treatment and follow-up were compared with the baseline.At the same time,the Patient Global Impression of Improvement(PGI-I),acupuncture expectation evaluation,blind evaluation and compliance evaluation were performed.Results:Due to the influence of COVID-19 epidemic situation on the recruitment and treatment time of this study,by the end of this paper,there were 46 voluntary subjects who met the diagnosis and inclusion exclusion criteria and completed the research,of which 5 cases fell off(1 case in electroacupuncture group and 4 cases in sham electroacupuncture group).The baseline of electroacupuncture group was consistent with that of sham electroacupuncture group,and the main curative effect indexes were collected in 43 subjects,including electroacupuncture group(n=20)and sham electroacupuncture group(n=23).The main outcome index was the change of the PFDI-20 baseline score compared with the score of the end of 3 months of treatment.The mean of the electroacupuncture group was-24.99,95%CI was(-35.93 to-14.04),the mean of the sham acupuncture group was-30.50,95%CI was(-43.94 to-17.08).After statistical analysis,the difference between the two groups compared with the baseline,there was no statistical significance(P=0.524).There were significant significance between the baseline and the end of 3 months of treatment in the electroacupuncture group and the sham electroacupuncture group(P<0.05).Secondary outcome indicators:(1)6 and 9 months after randomization,the changes of the PFDI-20 score compared with the baseline scores.Respectively,the median of electroacupuncture group was-25.00,Interquartile range(IQR)was 52.61,the mean was-31.50,the 95%CI was-49.3 to 13.66.Respectively,in the sham electroacupuncture group,the mean was-33.01,the 95%CI was-50.09 to-15.43,the median was-20.83,IQR was 71.36.There was no statistical significance between the two groups 6 and 9 months after randomization compared with the baseline(P6=0.965,P9=0.860).There were significant differences in the electroacupuncture group between the baseline and 6 and 9 months after randomization(P<0.05),and there were also significant differences in the sham electroacupuncture group between the baseline and 6 and 9 months after randomization(P<0.05).(2)The changes of the score of the PFIQ-7 between the baseline and the end of 3 months of treatment and 6 and 9 months after randomization.At the end of 3 months of treatment and 6 and 9 months after randomization,respectively,in the electroacupuncture group,the mean was-10.68,95%CI was-20.94 to-0.42,the mean was-17.11,95%CI was-25.98 to 8.24,the mean was-16.40,95%CI was27.03 to-5.77.In the sham electroacupuncture group,the change values of PFIQ-7 scale compared with the baseline,respectively,the median was-9.52,IQR was 30.95,The median was-14.29,IQR was 38.10,the median was-9.52,IQR was 40.48.At the end of 3 months of treatment and 6 and 9 months after randomization,the PFIQ-7 score of the two groups was compared with the baseline,and there was no significant difference between the two groups(P3=0.650,P6=0.938:P9=0.860).6 and 9 months after randomization,the scores of PFIQ-7 scale in the electroacupuncture group were significantly different between the baseline(P<0.05),and the score of PFIQ-7 scale at 6 months after random in the sham acupuncture group was significantly higher than that in the baseline group(P<0.05).(3)the changes of the scores of the ICIQ-SF between the baseline and the end of 3 months of treatment and 6 and 9 months after randomization.At the end of 3 months of treatment and 6 and 9 months after randomization,In the electroacupuncture group,respectively,the median was 0.00,IQR was 1.23,the median was 0.00,IQR 3.00,the median was-0.70,IQR was 3.50.In the sham electroacupuncture group,respectively,the median was-2.00,IQR was 3.50,the mean was-2.77,95%CI was-4.02 to-1.52,the mean was-3.24,95%CI was-4.52 to-1.96.At the end of 3 months of treatment and 9 months after randomization,the changes of ICIQ-SF scale scores of the two groups compared with the baseline were statistically analyzed(P3=0.025,P9=0.021).6 months after randomization,there was no significant difference between the two groups(P6=0.056).In the intra-group comparison,only the sham electroacupuncture group was significant difference(P<0.05)at 6、9 months after randomization.(4)the changes of the scores of the PISQ-12 between the baseline and the end of 3 months of treatment and 6、9 months after randomization.At the end of 3 months of treatment and 6 and 9 months after randomization,respectively,in the electroacupunture group,the median was 0.00,IQR was 2.00,the median was 0.00,IQR was 2.08,the median was 0.00,IQR was 1.90.And those in the sham electroacupuncture group,respectively,the median was 1.00,IQR was 5.11,the median was 0.00,IQR was 3.91,the median was 0.00,IQR was 5.57.At the end of 3 months of treatment and 6 months after randomization,there was no statistical difference in the changes of PISQ-12 scores compared with the baseline(P3=0.262,P6=0.452)between the two groups.At 9 months after randomization,the change of PISQ-12 score compared with the baseline was statistically analyzed(P9=0.040).At the end of 3 months of treatment and 6、9 months after randomization,there was no significant difference in the scores of PISQ-12 scale in the intra-group comparison(P>0.05).(5)the changes of PGI-I at the end of 3 months of treatment and 9 months after randomization.At the end of 3 months of treatment and 9 months after randomization,there was no significant difference in PGI-I between the two groups(P3=0.686,P9=0.889),and there was no significant difference the intra-group comparison at the end of 3 months of treatment and 9 months after randomization(P>0.05).(6)the changes of acupuncture expectation evaluation in baseline and the end of 3 months of treatment.After the baseline of the patients and the end of 3 months of treatment,there was no statistical significance in the evaluation between the two groups(P baseline=0.288,P3=0.127).Conclusions:Both electroacupuncture and sham electroacupuncture may alleviate the symptoms of mild to moderate pelvic organ prolapse and improve the quality of life of patients,but the effect size is small.There was no significant difference in most outcome indexes between electroacupuncture group and sham electroacupuncture group,and the effect of electroacupuncture was not better than that of sham electroacupuncture.Both electroacupuncture and sham electroacupuncture are safe.