| Background:Overactive bladder is a common clinical condition,with a prevalence rate of approximately 20.8%in China,that seriously affects patients’ quality of life and is closely associated with anxiety and depression.The significant impact of overactive bladder on daily life and emotions highlights the urgent need for effective interventions and suggests potential benefits of such interventions.Modern medicine faces challenges in treating OAB,as the conventional three-line treatment approach may not adequately meet clinical needs due to poor efficacy,high incidence of adverse reactions,and high costs.Therefore,it is crucial to identify effective,compliant,safe,and cost-effective therapies for OAB.Acupuncture,as one of the traditional Chinese medicine therapies,has been studied and explored for several years in treating OAB.Most clinical studies have shown potential efficacy and broad application prospects of acupuncture,but the majority of these studies are clinical observations and empirical summaries.The efficacy evaluation indicators are not consistent,and the research quality is low,which makes it difficult to gain international recognition.High-quality clinical trials with well-designed protocols are needed to confirm the efficacy of acupuncture in treating OAB.Thus,this study conducts in a randomized controlled clinical design,using sham acupuncture as a control,to obtain high-level evidence.The potential therapeutic mechanisms of acupuncture for OAB will be explored through the detection of relevant biomarkers in patients’ urine samples before and after treatment.Objective:To objectively evaluate the therapeutic efficacy of acupuncture for overactive bladder,with the aim of providing high-level evidence-based medicine for Traditional Chinese medicine treatments for this condition.The study also aims to explore the potential mechanisms of acupuncture treatment for OAB by examining the effects of acupuncture on relevant biomarkers in urine.Methods:This study conducts in a prospective,randomized,sham-acupuncture-controlled design,with blinding implemented for the participants,outcome assessors,and statisticians.Participants were recruited from December 2021 to December 2022 at the Department of Urology of Guang’anmen Hospital,China Academy of Chinese Medical Sciences,or through public recruitment of patients with overactive bladder who met the criteria.Eligible participants were randomized into an acupuncture treatment group or a sham acupuncture group.The acupuncture treatment group received needling at bilateral Zhongliao(BL32),Huiyang(BL35),Zusanli(ST36),and Sanyinjiao(SP6)with electrical stimulation applied to Zhongliao(BL32)and Huiyang(BL35)during needling.The sham acupuncture group received superficial needling(2 mm depth)at non-acupoint sites adjacent to the acupuncture sites selected for the treatment group without electrical stimulation.Both groups received a 30-minute treatment session three times a week for eight weeks.The primary outcome was the change in 24-hour micturition frequency from baseline to week 8,and secondary outcomes included changes in daytime and nighttime micturition frequency,urgency episodes,average voided volume,OABSS score,OAB-q SF score,and the concentrations of NGF and BDNF in urine.Safety was assessed by recording any adverse events during the study and evaluating their relationship with the intervention received by the participants.The incidence and severity of adverse events were compared between the two groups to evaluate the safety of the intervention after the study.Results:A total of 60 participants were ultimately included in this study,with 30 participants in both the acupuncture treatment group and the sham acupuncture group.①The primary outcome:After 8 weeks of intervention,there was a statistically significant difference in the change in 24-hour micturition frequency between the two groups(-1.97,P<0.01).Both groups showed a reduction in 24-hour micturition frequency compared to baseline at week 8.The acupuncture group had a statistically significant decrease of-2.78 times(P<0.01),while the sham acupuncture group had a non-statistically significant decrease of-0.81 times(P=0.36).The difference in the change of 24-hour micturition frequency between the two groups increased gradually before the 8th week of treatment,slightly decreased at week 20,but still remained statistically significant.②Secondary outcomes:There was a statistical difference in the distribution of changes in the frequency of 24-hour urgency episodes between the two groups at the end of the 8-week intervention.The acupuncture group had a higher median change in urgency episodes compared to the control group(median difference of-2.00,P<0.01).At all observation time points for the outcome measures,the acupuncture group had higher changes in 24-hour urgency episodes compared to the control group.A statistically significant difference was observed at the 4-week follow-up,and the difference of change between the two groups increased during the first 8 weeks of the intervention.At the week 20,the difference between the two groups was slightly reduced,but still statistically significant.At each observation time point,the change of the number of daytime and nighttime micturition in the acupuncture treatment group was higher than that in the sham-acupuncture group.The difference in the change in the number of 24-hour daytime and nighttime micturition between the two groups was statistically significant as early as the 4-week follow-up and was maximal at 8 weeks of treatment.There were no statistically significant differences in the changes in 24hour average urine volume between the acupuncture treatment group and the control group at each observation time point,and no statistically significant differences were found between the two groups.The change in OABSS scores from baseline in the acupuncture group was higher than that in the sham-acupuncture group at all follow-up time points.At the end of the 8-week intervention,both groups had significantly reduced OABSS scores compared to baseline,and there was a statistically significant difference between the two groups(-2.2,P<0.01).The mean change in OABSS scores from baseline in the acupuncture group was higher than the MCID of 3 points.At the 20-week follow-up,the difference in OABSS score change from baseline remained statistically significant in the acupuncture group(difference of-2.95 points,P<0.01),while there was no statistically significant difference in the sham-acupuncture group.The difference in OABSS score change between the two groups remained statistically significant(difference of-1.75 points,P<0.01).At the end of the 8-week intervention,there were statistically significant differences in the change from baseline in the OAB-q SF symptom bother scores between all groups,and the difference between the two groups was statistically significant(difference-13.44,P=0.04).The change from baseline in the OAB-q SF symptom bother scores in the acupuncture group was higher than the MCID of 11 points at both week 8 and week 20.At the 4-week follow-up,there was a statistically significant difference in the difference in score changes between the two groups,and this difference continued to increase at each subsequent follow-up.The largest difference between the groups was observed at the 20-week follow-up(10.99,P=0.02),but there was no time point at which the difference in change between the two groups reached the MCID of the scale.At baseline,urinary levels of NGF/Cr,BDNF/Cr,and MCP-1/Cr were higher in both groups of subjects.After an 8-week intervention period,the acupuncture group showed a significant decrease in urinary levels of NGF/Cr and BDNF/Cr compared to baseline,and the difference was statistically significant when compared to the sham acupuncture group.There was no statistically significant difference in urinary levels of MCP-1/Cr before and after treatment in either group.③Safety assessment:During the study,no serious adverse events were observed in either group of subjects.The incidence of mild adverse events in the acupuncture treatment group was 13.33%,while the incidence of mild adverse events in the sham acupuncture group was 6.67%.There was no statistically significant difference in the incidence of adverse events between the two groups(P=0.67).Conclusion:Through a prospective,randomized,sham-acupuncture-controlled study design,this study concludes that acupuncture can significantly improve the 24-hour micturition frequency and urgency episodes,enhance the quality of life,and sustain therapeutic effects for at least 12 weeks after acupuncture treatment.Acupuncture can reduce the levels of urinary NGF and BDNF in individuals with overactive bladder.Sham acupuncture may have some therapeutic effect on overactive bladder. |
PDF Full Text Request