| ObjectiveThis study is to assess the efficacy and safety of acupuncture at Qugu acupoint(CV2)for men with BPH,and to provide objective clinical evidence using computerized tomography(CT)localization images.MethodsA single-center,subject-and assessor-blinded,randomized,controlled clinical study were conducted in the outpatient acupuncture department of the Xiyuan hospital of China Academy of Chinese Medical Sciences between January,2020,and March,2022.A total of 72 subjects with BPH who met the study criteria were randomized to the test group(acupuncture at CV2 with needle tip reaching the prostate capsule)and the control group(acupuncture at CV2 with needle tip 10mm away from the prostate capsule)in a 1:1 ratio.The study period for each subject was 16 weeks,including 4 weeks baseline observation period,4 weeks intervention period,and 8 weeks followup period.All subjects received 10 treatments during the intervention period.The trial and control group were measured the needle depth and angle by CT in their first treatment.The efficacy of the treatment was evaluated with reference to the "grading and scoring criteria for symptoms,signs and auxiliary examinations".The primary endpoint was the change in International Prostate Symptom Score(I-PSS).Secondary endpoints include quality of life(QoL),maximum urinary flow rate(Qmax),post-void residual(PVR),and prostate volume(PV).Safety indicators included needle tolerance scores,needle discomfort scores,and recording of adverse events.Two independent samples t-test or Mann-Whitney U-test was used for group comparisons of the two data sets.Paired t-test or Wilcoxon signed rank sum test was used to compare the data within groups.P<0.05 was considered statistically significant.The pre-and post-treatment data were entered into full analysis set(FAS)and safety set(SS)analyses,and the follow-up period data were entered into the protocol set(PPS)analysis.ResultsA total of 72 patients were enrolled,one case was shed in each of the groups during treatment,and one case was shed in the control group during the follow-up period,72 into FAS and SS,69 into PPS.General information such as age and disease duration,as well as I-PSS score,QoL score,Qmax,PVR,and PV at baseline were not significantly different between the trial and the control groups(P>0.05))and were comparable.The results showed that the efficacy of the test group(82.86%)was better than that of the control group(60.00%)in terms of total treatment efficiency,and the differences were statistically significant(P<0.05).There were significant differences in the endpoints of I-PSS scores,QoL scores,and Qmax between the trial and the control groups after treatment(P<0.05),and compared with the same group before treatment,there were significant differences in I-PSS scores,QoL scores,and Qmax between the two groups after treatment(P<0.05).The differences in the endpoints of PVR and PV between the two groups after treatment were not statistically significant(P>0.05),and there was no significant difference in the two groups before and after treatment treatment(P>0.05).69 patients were followed up at week 16:the test group showed better improvement in I-PSS score and QoL score than that in the control group,and the difference between the two groups was statistically significant(P<0.05).There was no significant difference in I-PSS scores and QoL scores between the two groups compared with the same group at week 8(P>0.05),indicating that the improvement in I-PSS scores and QoL scores lasted until week 16 in both groups and that the test group was better than the control group.The results of the safety analysis of 72 patients who entered the safety set(SS)were as follows:Needle tolerance scores in both the test and control groups ranged from 2 to 4(acceptable to very easy to accept),with a median score of 3(easy to accept)in both groups,and there was no significant difference in needle tolerance scores between the two groups(P>0.05).Needle discomfort in the test group ranged from 0 to 4 points,and ranged from 0 to 3 points in the control group,both groups had no strong needle discomfort,and there was no significant difference in the comparison of needle discomfort between the two groups(P>0.05).A total of 2 cases(2.78%)experienced adverse reactions during the treatment,both of which were localized pain after acupuncture,and the pain resolved on its own for about 2 days without adverse events.ConclusionCT-located acupuncture at the CV2 was safe and effective in the treatment of BPH.Acupuncture at the CV2 to the prostate capsule was superior to acupuncture at the CV210 mm away from the prostate capsule in terms of total efficiency and improvement of I-PSS score,QoL score and the maximum urinary flow rate.The long-term efficacy of both groups on the I-PSS score and QoL score lasted until 8 weeks after the end of treatment.But there was no significant improvement on PVR and PV in both groups after treatment.Local pain after acupuncture occurred in 2.78%of patients during treatment,and acupuncture at the CV2 was safe for the treatment of BPH. |
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