Introduction Chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS) affects around 35%–50% of men during their lifetime. The efficacy of current oral medication for CP/CPPS remains limited. Recent studies demonstrated that vagus nerve stimulation may improve chronic pelvic and abdominal pain. Accordingly, transcutaneous auricular vagus nerve stimulation (taVNS) might represent a promising, non-invasive therapeutic approach for the clinical management of CP/CPPS.Methods and analysis The trial of Transcutaneous Auricular vagus nerve Stimulation for moderate to severe Chronic Prostatitis/CPPS is a prospective, randomised, sham-controlled trial with a 1:1 allocation ratio. Participants will be assigned randomly to either the taVNS group or the sham-taVNS group. The intervention period will consist of a 4-week treatment (a total of 40 sessions), followed by an 8-week follow-up period. The primary outcome is the change from baseline in the National Institutes of Health Chronic Prostatitis Symptom Score Index total score at week 4. Secondary outcomes include the International Prostate Symptom Score Scale, European Quality of Life 5-Dimensions-5-Levels questionnaire, Self-Rating Anxiety Scale and Self-Rating Depression Scale. Safety assessments will be conducted throughout the entire study period.Ethics and dissemination This study protocol and informed consent documents were reviewed and approved by the Institutional Review Board of Guang’anmen Hospital, China Academy of Chinese Medical Sciences (approval number: 2023-250 KY). Written informed consent will be obtained from all participants and/or their legal guardians prior to trial participation. The findings will be disseminated through publication in a peer-reviewed journal and presentations at scientific conferences. The research data will be made available on reasonable request.Trial registration number NCT06287970.
Lower urinary tract dysfunction (LUTD) is an umbrella diagnosis covering a group of urological disorders, and its symptoms not only distress patients but also dramatically diminish their quality of life. Despite the range of conventional treatments on offer, managing lower urinary tract symptoms continues to pose a significant challenge. Complementary and alternative medicine, as an alternative treatment beyond mainstream treatments, has been employed to manage these symptoms. In this chapter, we try to establish the evidence regarding the efficacy and possible mechanism of complementary and alternative medicine in treating lower urinary tract symptoms. Although existing evidence is limited, complementary and alternative medicine is relative non-invasive, and each therapeutic approach could likely offer substantial benefits to a considerable number of patients.
Pelvic floor disorders (PFDs) refer to a group of conditions comprising pelvic organ prolapse (POP), urinary incontinence, and urination or defecation abnormalities caused by weakened or damaged pelvic floor muscles, nerves, and connective tissues. The pelvic muscles, fascia, or ligaments around the pelvic organs, present an anatomical hammock across the pelvic floor. They play a vital role in supporting the normal function of pelvic organs. Once these muscles or connective tissues are damaged due to some reasons, the PFDs will consequently occur. Up to now, the diagnosis and treatment of PFDs are still filled with challenges due to the various etiology and symptoms of PFDs. In this chapter, we focus on urinary incontinence and POP, the two common conditions of PFDs, besides general introduction to PFDs. Not only is the latest evidence reviewed but also our viewpoint is presented. In general, PFDs involve urology, gynecology, anorectal department, and other fields, and the disciplines are usually associated with each other. Therefore, a multidisciplinary approach is usually necessary. With a developed understanding of the anatomy and function of the pelvic floor, pelvic floor reconstruction has received much attention and more new technologies are also constantly emerging, developed to improve the traditional methods.
Background: Overactive bladder (OAB) is a prevalent condition that substantially degrades patient quality of life. Acupuncture is recognized as an effective therapeutic approach for various urological diseases. However, there is limited evidence validating the effectiveness and safety of acupuncture for OABs. Objective: To assess the therapeutic efficacy of acupuncture for OAB and to investigate the potential mechanisms by analyzing its effects on relevant urinary biomarkers. Methods: This is a randomized, participants and outcome assessors blinded, sham acupuncture controlled trial. A total of 110 patients with OABs will be randomly divided in a 1:1 ratio between the acupuncture and sham acupuncture groups. Participants in the acupuncture group will undergo 30-min authentic acupuncture, while their counterparts in the sham acupuncture group will undergo sham acupuncture needling non-acupoints superficially three times weekly for a duration of 8 weeks. The two co-primary outcomes will be the change in the mean number of micturitions per 24 h from baseline to the end of the 8-week treatment and 20-week follow-up. The secondary outcomes will encompass the change in Overactive Bladder Symptom Score, Overactive Bladder Questionnaire Short Form, and average 24 h values of urgency, daytime micturition, nocturia, and mean volume voided per micturition from baseline to weeks 8 and 20. Urinary nerve growth factor, brain-derived neurotrophic factor, and monocyte chemoattractant protein-1 levels will be measured at baseline and week 8. Adverse events will also be documented. Discussion: The results of this trial will provide evidence for the effectiveness and safety of acupuncture in the management of OAB.
BackgroundChronic prostatitis/chronic pelvic pain syndrome (CP/CPPS) has posed a significant burden on affected individuals and healthcare systems. While pharmacological treatments are commonly used, non-pharmacological management strategies have gained attention for their potential benefits in improving CP/CPPS symptoms. However, the comparative efficacy of these non-pharmacological interventions remains unclear. The aim of this study is to assess the comparative effectiveness of non-pharmacological interventions for CP/CPPS regarding prostatic symptoms.MethodThis systematic review and network meta-analysis will follow the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. A comprehensive search will be conducted in electronic databases, including PubMed, Embase, Cochrane Library and Web of Science, to identify relevant studies. Eligible studies will include randomised controlled trials investigating non-pharmacological management strategies for CP/CPPS. Two independent reviewers will screen the retrieved citations, extract data and assess the risk of bias. Data synthesis will involve performing a network meta-analysis to compare the efficacy of different non-pharmacological interventions while considering both direct and indirect evidence.Ethics and disseminationThe review does not require ethical approval. The findings of the review will be disseminated through publication in an academic journal, presentations at conferences and various media outlets.PROSPERO registration numberCRD42024506143.
OBJECTIVE:To evaluate the efficacy and safety of a wearable, smartphone-controlled, rechargeable transcutaneous tibial nerve stimulation (TTNS) device in patients with overactive bladder (OAB). PATIENTS AND METHODS:This multicentre, prospective, single-blind, randomised clinical trial included eligible patients with OAB symptoms who were randomly assigned to the stimulation group or sham group. The primary efficacy outcome was change from baseline in voiding frequency/24 h after 4 weeks of treatment. The secondary efficacy outcomes included changes in bladder diary outcomes (urgency score/void, nocturia episodes/day, micturition volume/void, and incontinence episodes/day), questionnaires on Overactive Bladder Symptom Score (OABSS), Patient Perception of Bladder Condition (PPBC), and American Urological Association Symptom Index Quality of Life Score (AUA-SI-QoL) at baseline and after 4 weeks of treatment. Device-related adverse events (AEs) were also evaluated. RESULTS:In the full analysis set (FAS), the mean (sd) change of voiding frequency/24 h in the stimulation group and sham group at 4 weeks were -3.5 (2.9) and -0.6 (2.4), respectively (P < 0.01). Similar results were obtained in the per-protocol set (PPS): -3.5 (2.9) vs -0.4 (2.3) (P < 0.01). In the FAS and PPS, micturition volume/void significantly improved at 4 weeks (P = 0.01 and P = 0.02). PPBC improvement almost reached significance in the FAS (P = 0.05), while it was significant in the PPS (P = 0.02). In the FAS and PPS, AUA-SI-QoL significantly improved at 4 weeks in the two groups (P < 0.01 and P < 0.01), whereas there were no significant differences in urgency score/void, nocturia episodes/day or OABSS between the groups. Also, no device-related serious AEs were reported. CONCLUSIONS:The non-invasive neuromodulation technique using the novel ambulatory TTNS device is effective and safe for treating OAB. Its convenience and easy maintenance make it a new potential home-based treatment modality. Future studies are warranted to confirm its longer-term efficacy.
目的 基于数据挖掘技术分析和总结高荣林教授治疗失眠的用药规律.方法 选取 2020年 10月至 2022年10月中国中医科学院广安门医院高荣林教授门诊失眠患者的病案,采用Microsoft Excel 2016 和Rstudio 4.2.1 统计软件对药物的频次、四气、五味、归经、功效进行统计,对高频药物进行关联规则及聚类分析,并使用VOSviewer软件进行复杂网络可视化.结果 358 首处方中共涉及中药 146 味,累计使用频次 4 947,使用频次>90 次的有酸枣仁、白芍、远志等20味中药;药物四气以平、温、寒居多,五味以甘、苦、辛为主,归经以肝、心、脾经为主;使用频率最高的药物是补虚药和安神药;聚类分析结果显示,支持度和频次均最高的药物组合为远志-酸枣仁,其次为牡丹皮-酸枣仁、黄连-酸枣仁,置信度最高的药物组合分别有肉桂-酸枣仁、黄连、肉桂-酸枣仁;聚类分析可分为 4类.结论 高荣林教授治疗失眠多从肝、心、脾入手,注重治心调神、调理脾胃,常用黄连、肉桂及酸枣仁药对配伍以交通心神、补肾温阳.
目的:基于数据挖掘方法探讨高荣林对失眠的诊治规律.方法:从中国中医科学院广安门医院门诊病历系统中导出高荣林2020年10月1日至2022年10月1日诊治的失眠患者病案,建立数据库,采用Excel对患者性别、年龄、病位证素、病性证素及证型分布进行频次统计,并运用中医传承辅助平台分析主要证型的处方用药规律.结果:男女患者的比例为9:11,涉及青少年、青壮年、老年人3个年龄段,其中以41~60岁人群为主,占总人数的61.8%(194/314);病位证素包括五脏和胆胃,以肝、肾、脾为主;病性以血虚、肝郁、内热、阴阳失调为主;证型分布达67种,包括39种独立证型和28种复合证型,其中血虚肝旺证出现频次最高,白芍、当归、酸枣仁、郁金、远志、熟地黄、川芎、柴胡为治疗血虚肝旺型失眠的常用核心药物,常用药对有当归-酸枣仁、白芍-当归、白芍+当归-酸枣仁.结论:高荣林治疗失眠重视脏腑辨证,对于血虚肝旺型失眠擅用白芍、当归、酸枣仁、郁金、远志、熟地黄、川芎、柴胡等养血柔肝、疏肝安神,常当归与白芍,白芍、当归与酸枣仁,酸枣仁与当归配伍应用,从整体上调阴阳、补虚、畅情志,从而改善失眠.
Hot flashes are the common and debilitating symptom among prostate cancer (PCa) patients undergoing androgen deprivation therapy (ADT). Strong evidence from multiple rigorously designed studies indicated that pharmacological option such as venlafaxine provides partial relief, but the tolerability is poor when dose is not tapered. Hence, alternative therapy is needed. Previous studies reported that acupuncture may be helpful in the management of hot flashes. However, the insufficient randomized controlled trial limited the quality of evidence. Five hospitals will recruit 120 acupuncture naïve patients with moderate-to-severe hot flashes after prostate cancer received ADT in China from February 2023 to December 2024. Participants will be randomly 2:1:1 allocated to the 18 sessions of verum acupuncture at true acupuncture points plus usual care, 18 sessions of non-penetrating sham acupuncture at non-acupuncture points plus usual care, or usual care alone over 6 weeks. The primary outcome measure is the change of mean weekly hot flashes symptom severity score (HFSSS) at the end of treatment compared with baseline. We will be able to measure the effectiveness of acupuncture for patients with PCa suffering from ADT-induced hot flashes and whether acupuncture is superior to sham acupuncture and usual care. The proposed acupuncture treatment might provide an alternative option for those patients. Clinicaltrials.gov (NCT05069467).
目的 基于数据挖掘技术分析针灸治疗夜尿症的选穴思路与特点.方法 通过检索中国知网、PubMed等数据库中关于针灸治疗夜尿症的临床文献,建立数据库,采用Excel统计腧穴频次、归经、特定穴及分布部位,并运用中医传承辅助平台 3.0 版对腧穴进行关联规则和聚类分析.结果 共纳入 63 篇文献,87 个选穴处方,涉及 82 个腧穴,腧穴总使用频次为 506 次.关元的使用频次居首位,其次为气海、肾俞;所选腧穴使用频次较高的经脉分别为任脉、足太阳膀胱经、足少阴肾经;使用频次居前 3 位的特定穴为交会穴、募穴和背俞穴;所选腧穴多分布于腹部、背部和下肢.关联规则中,气海-关元、气海-肾俞-关元与肾俞-中极-关元为核心腧穴组合,聚类分析中,关元、肾俞、气海、三阴交、中极为主要核心聚类群.结论 针灸治疗夜尿症多常用关元、气海、三阴交、中极、肾俞和足三里穴,以任脉、足太阳膀胱经腧穴为主,多集中于腹部与背部,交会穴、募穴和背俞穴为常用特定穴,多采用经络与脏腑病位辨证相结合、局部选穴与远端选穴相结合的方法.
良性前列腺增生是中老年男性常见排尿障碍性疾病,严重影响患者生活质量.对比现代医学治疗,中医治疗具有明显优势.文章基于东垣学说理论和临床实践经验,认为良性前列腺增生从属"脾胃虚则九窍不通"范畴,而"脾胃气虚、升降失调、湿浊下流、肾失开阖"为本病发生发展的病机关键,与李东垣提出"阴火"理论类似,治疗可遵"补中、升阳、泻阴火"之法,随证加减,临床取得一定疗效,可为临床提供一定参考.
Background Pharmacological treatments for chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS) are empirically used. However, the quantitative comparative effectiveness and safety of multiple pharmacological treatments is lacking. Methods PubMed, Embase, Cochrane Central Register of Controlled Trials, and Web of Science were searched from inception to March 22, 2022. Randomised controlled trials comparing two or more oral pharmacological treatments for patients with CP/CPPS were included. Title, abstract, and full-text screening were independently screened by four reviewers. Primary outcomes were efficacy (the National Institutes of Health Chronic Prostatitis Symptom Index [NIH-CPSI] total score, pain score, urinary score, and quality of life score [QoL]) and safety (adverse events). This study was registered with PROSPERO, CRD42020184106. Findings 25 studies (3514 patients) assessed 26 treatments. Low to very low quality evidence indicated that doxazosin (Mean difference [MD], -11.4, 95% Credible interval [CrI], -17.5 to -5.1) and the doxazosin, ibuprofen, and thiocolchicoside combination (MD, -11.6, CrI, -18.1 to -5.3) were significantly more effective than placebo in the NIH-CPSI total score. Other NIH-CPSI relative outcomes (pain, urinary, and QoL scores) showed a similar pattern. Low and very low quality evidence suggested that combination treatment including doxazosin, ibuprofen, and thiocolchicoside (odds ratios [OR], 3.2, CrI, 0.5 to 19.3) and the tamsulosin and dapoxetine combination (OR, 6.0, CrI, 0.7 to 67.3) caused more adverse events. In half of all comparisons regarding NIH-CPSI pain scores and quality of life scores, heterogeneity was minimal or low. Heterogeneity was high in both NIH-CPSI total symptom scores (I-2 = 78.0%) and pain scores (I-2 = 87. 0%) for tamsulosin versus placebo. There was also high heterogeneity in NIH-CPSI urine scores for the combination of tamsulosin and ciprofloxacin versus tamsulosin (I-2 = 66.8%), tamsulosin and levofloxacin versus tamsulosin (I-2 = 93.3%), and tamsulosin versus placebo (I-2 = 83%). Interpretation Pharmacological treatments have little evidence supporting efficacy in CP/CPPS. Future studies could personalise therapy for individuals according to specific symptoms and identify non-pharmacological targets for CP/CPPS. Copyright (C) 2022 The Authors. Published by Elsevier Ltd.
INTRODUCTION:The terminology for sexual health in men with lower urinary tract (LUT) and pelvic floor (PF) dysfunction has not been defined and organized into a clinically based consensus terminology report. The aim of this terminology report is to provide a definitional document within this context that will assist clinical practice and research.METHODS:This report combines the input of the members of sexual health in men with LUT and PF Dysfunction working group of the International Continence Society (ICS), assisted at intervals by external referees. Appropriate core clinical categories and a sub-classification were developed to give coding to definitions. An extensive process of 18 rounds of internal and external review was involved to exhaustively examine each definition, with decision-making by collective opinion (consensus). The Committee retained evidence-based definitions, identified gaps, and updated or discarded outdated definitions. Expert opinions were used when evidence was insufficient or absent.RESULTS:A terminology report for sexual health in men with LUT and PF dysfunction, encompassing 198 (178 NEW) separate definitions, has been developed. It is clinically based with the most common diagnoses defined. Clarity and user-friendliness have been key aims to make it interpretable by practitioners and trainees in all the different speciality groups involved. Conservative and surgical managements are major additions and appropriate figures have been included to supplement and clarify the text. Emerging concepts and measurements, in use in the literature and offering further research potential, but requiring further validation, have been included as an appendix. Interval (5-10 years) review is anticipated to keep the document updated.CONCLUSION:A consensus-based terminology report for sexual health in men with LUT and PF dysfunction has been produced to aid clinical practice and research. The definitions that have been adopted are those that are most strongly supported by the literature at this time or are considered clinical principles or consensus of experts' opinions.
Background: Polycystic ovary syndrome (PCOS) is one of the most common disorders of reproductive endocrinology affecting women of reproductive age. Our study aims to explore the feasibility of a full-scale trial to evaluate the efficacy and safety of acupuncture for PCOS. Methods: This study is a two-armed, parallel, multi-country, multi-center, pilot randomized controlled trial (RCT) for PCOS with oligomenorrhea. We will recruit 60 women aged 20 to 40 years with oligomenorrhea due to PCOS. The participants will be randomly assigned to acupuncture and control groups. The acupuncture group will undergo a total of 40 sessions for 16 weeks with usual care. The control group will be managed with usual care (regular meals, sufficient sleep, and appropriate exercise) only. The primary clinical outcome is mean change in menstrual frequency from baseline to 16 weeks and 32 weeks (follow-up) after the start of the trial. The secondary outcomes are menstrual period, levels of estradiol, luteinizing hormone (LH), follicle-stimulating hormone (FSH), and total testosterone, LH/FSH ratio, antral follicle count and ovarian volume, body mass index, waist hip ratio, acne severity, and health-related quality of life questionnaire scores at 16 and 32 weeks after the start of the trial. Discussion: This is the first protocol for multi-country, multi-center RCTs for PCOS in Korea and China. The control group in this study will be subjected to usual care (regular meals, enough sleep, and appropriate exercise). The results of this study will provide evidence for future clinical decisions and guidelines. This trial has been registered at ClinicalTrials.gov (Identifier: NCT04509817).
BACKGROUND:Lower urinary tract symptoms (LUTS) due to benign prostatic obstruction (BPO) represent one of the most common clinical complaints in men. Alpha-blockers are widely used as first-line therapy for men with LUTS secondary to BPO, but up to one third of men report no improvement in their LUTS after taking alpha-blockers. Anticholinergics used in addition to alpha-blockers may help improve symptoms but it is uncertain how effective they are. OBJECTIVES: To assess the effects of combination therapy with anticholinergics and alpha-blockers in men with LUTS related to BPO. SEARCH METHODS:We performed a comprehensive search of medical literature, including the Cochrane Library, MEDLINE, Embase, and trials registries, with no restrictions on the language of publication or publication status. The date of the latest search was 7 August 2020. SELECTION CRITERIA:We included randomized controlled trials. Inclusion criteria were men with LUTS secondary to BPO, ages 40 years or older, and a total International Prostate Symptom Score of 8 or greater. We excluded trials of men with a known neurogenic bladder due to spinal cord injury, multiple sclerosis, or central nervous system disease, and those examining medical therapy for men who were treated with surgery for BPO. We performed three comparisons: combination therapy versus placebo, combination therapy versus alpha-blockers monotherapy, and combination therapy versus anticholinergics monotherapy. DATA COLLECTION AND ANALYSIS:Two review authors independently screened the literature, extracted data, and assessed risk of bias. We performed statistical analyses using a random-effects model and interpreted data according to the Cochrane Handbook for Systematic Reviews of Interventions. We used the GRADE approach to rate the certainty of evidence. MAIN RESULTS:We included 23 studies with 6285 randomized men across three comparisons. The mean age of participants ranged from 54.4 years to 73.9 years (overall mean age 65.7 years). Of the included studies, 12 were conducted with a single-center setting, while 11 used a multi-center setting. We only found short-term effect (12 weeks to 12 months) of combination therapy based on available evidence. Combination therapy versus placebo: based on five studies with 2369 randomized participants, combination therapy may result in little or no difference in urologic symptom scores (mean difference (MD) -2.73, 95% confidence interval (CI) -5.55 to 0.08; low-certainty evidence). We are very uncertain about the effect of combination therapy on quality of life (QoL) (MD -0.97, 95% CI -2.11 to 0.16; very low-certainty evidence). Combination therapy likely increases adverse events (risk ratio (RR) 1.24, 95% CI 1.04 to 1.47; moderate-certainty evidence); based on 252 adverse events per 1000 participants in the placebo group, this corresponds to 61 more adverse events (95% CI 10 more to 119 more) per 1000 participants treated with combination therapy. Combination therapy versus alpha-blockers alone: based on 22 studies with 4904 randomized participants, we are very uncertain about the effect of combination therapy on urologic symptom scores (MD -2.04, 95% CI -3.56 to -0.52; very low-certainty evidence) and QoL (MD -0.71, 95% CI -1.03 to -0.38; very low-certainty evidence). Combination therapy may result in little or no difference in adverse events rate (RR 1.10, 95% CI 0.90 to 1.34; low-certainty evidence); based on 228 adverse events per 1000 participants in the alpha-blocker group, this corresponds to 23 more adverse events (95% CI 23 fewer to 78 more) per 1000 participants treated with combination therapy. Combination therapy compared to anticholinergics alone: based on three studies with 1218 randomized participants, we are very uncertain about the effect of combination therapy on urologic symptom scores (MD -3.71, 95% CI -9.41 to 1.98; very low-certainty evidence). Combination therapy may result in an improvement in QoL (MD -1.49, 95% CI -1.88 to -1.11; low-certainty evidence). Combination therapy likely results in little to no difference in adverse events (RR 1.26, 95% CI 0.81 to 1.95; moderate-certainty evidence); based on 115 adverse events per 1000 participants in the anticholinergic alone group, this corresponds to 4 fewer adverse events (95% CI 7 fewer to 13 more) per 1000 participants treated with combination therapy. AUTHORS' CONCLUSIONS:Based on the findings of the review, combination therapy with anticholinergics and alpha-blockers are associated with little or uncertain effects on urologic symptom scores compared to placebo, alpha-blockers, or anticholinergics monotherapy. However, combination therapy may result in an improvement in quality of life compared to anticholinergics monotherapy, but an uncertain effect compared to placebo, or alpha-blockers. Combination therapy likely increases adverse events compared to placebo, but not compared to alpha-blockers or anticholinergics monotherapy. The findings of this review were limited by study limitations, inconsistency, and imprecision. We were unable to conduct any of the predefined subgroup analyses.
Background Chronic prostatitis/chronic pelvic pain syndromes (CP/CPPS) is a common heterogeneous disease that seriously impacts patients' quality of life (QoL). Acupuncture therapy has been widely used in China for various urinary diseases and symptoms, including chronic prostatitis. The results of several randomized controlled studies from different countries support that acupuncture can relieve the symptoms of CP/CPPS. Still, most randomized controlled trial (RCT) trials focus on symptom relief in patients, and the evidence on improving the QoL is insufficient. This study aims to assess the near-term and long-term efficacy of acupuncture in improving QoL in patients with CP/CPPS.