| ObjectiveTo evaluate the efficacy and safety of "Deeply Acupuncture at CV 2" with C T localization in the treatment of Benign Prostatic Hyperplasia,and to provide scie ntific reference for clinical treatment of Benign Prostatic Hyperplasia.MethodA single-center,single-blind,randomized,"sham acupuncture" placebo-controlle d clinical trial design was used in this study.According to the sample size estimat ion formula which applies to the "excellent efficiency of clinical trials",and under the condition of the inclusion and exclusion criteria formulated in this study,78 patients were eventually included.On the basis of the random numbers table with SPSS 22.0 generating,78 patients with Benign Prostatic Hyperplasia were randoml y divided into treatment group and control group by the sealed envelope,and each group has 39 cases.The treatment group was treated with "Deeply Acupuncture a t CV 2" with CT localization.The depth and angle of "Deeply Acupuncture at C V 2" were measured through CT positioning,and the measurement were recorded.According to the measurement,the needle tip was touched the prostatic capsule thr ough the gap between the pubis and the bladder.Mild reinforcing-attenuating was treated to make the needling sensation conduct to the perineum or have a feeling of urination,and the needle was left for 25 minutes.The control group was treate d with "sham acupuncture",and the needle was also left for 25 minutes.The freq uency and course of treatment were the same in both groups.The treatment was o nce every other day in the first 2 weeks,3 times a week,and the treatment was once every two days in the second 2 weeks,2 times a week,which was a total o f 10 times for 4 weeks.After treatment,SPSS 22.0 was used for analysis of Inter national Prostate Symptom Score,Maximum Urine Flow Rate,Prostate Volume,Qu ality of Life,Residual Urine Volume before and after treatment,and discomfort sc ore of acupuncture,tolerance score of acupuncture,safety evaluation of acupunctur e,International Prostate Symptom Score and Quality of Life during in the 8-week follow-up period in two groups.To evaluate the differences of efficacy between th e treatment group and control group,and to evaluate the safety of the treatment o f Benign Prostatic Hyperplasia by "Deeply Acupuncture at CV 2" with CT localiza tion.ResultA total of 72 cases were included in this study.38 patients were eventually i ncluded in the treatment group,and 34 patients were eventually included in the co ntrol group because of 1 patient of self-shedding in the treatment group,2 patients of self-shedding and 3 patients of loss to follow-up in the control group.All six of them were ultimately determined as shedding cases.In the study,There were n o statistical differences in age,course of Benign Prostatic Hyperplasia,International Prostate Symptom Score,Prostate Volume,Residual Urine Volume,Quality of Lif e score and Maximum Urine Flow Rate between the two groups before treatment(P>0.05),and the two groups of treatment and control were comparable.After trea tment,the treatment group’s total effective rate was 81.6%,which was better and superior than that of the control group by 17.6%(P<0.05).Compared with before treatment,the treatment group could obtain improvement which was reflected in e nhancing the Maximum Urine Flow Rate and reducing the Quality of Life score a nd International Prostate Symptom Score(P<0.05),but reducing Prostate Volume a nd Residual Urine Volume had not significant improvement(P>0.05).At the same time,the control group had not significant and obvious improvement,which was r eflected in enhancing Maximum Urine Flow Rate,reducing Quality of Life score,International Prostate Symptom Score,Prostate Volume,and decreasing Residual Ur ine Volume(P>0.05).In the group comparison,the treatment group was better tha n the control group in marking down Quality of Life score,International Prostate Symptom Score and enhancing the Maximum Urine Flow Rate(P<0.05),and there was no statistical differences between the two groups,which was reflected in dec reasing Residual Urine Volume and reducing Prostate Volume(P>0.05).Compared with the same group which was after treatment,there were also no statistical diffe rences in International Prostate Symptom Score and Quality of Life between two g roups during in the 8-week follow-up period(P>0.05).ConclusionAfter 4-week and a total of 10-time of the treatment,"Deeply Acupuncture at CV 2" with CT Localization can reduce International Prostate Symptom Score,Q uality of Life score and increase Maximum Urine Flow Rate,and can improve cli nical symptoms which include the feeling of endless urination,narrowing of urinar y line,lower abdominal fullness,and urinary waiting.Furthermore,it also can red uce nocturia and improve life’s quality.At the same time,the curative effect was stable after 8-week of follow-up.The technology of "Deeply Acupuncture at CV 2" with CT Localization,no obvious discomfort,is easy to be accepted.Therefore,"Deeply Acupuncture at CV 2" with CT Localization,in the treatment of Benign Prostatic Hyperplasia,is effective and safe. |
