Electroacupuncture versus solifenacin succinate for female overactive bladder: study protocol for a multicentre, randomised, controlled, double-dummy, non-inferiority trial.

INTRODUCTION: Overactive bladder (OAB) affects approximately 500 million people worldwide, with a higher prevalence in women than in men, significantly impacting the quality of life of female patients. Treatment options for OAB are currently limited. Previous research has proposed that electroacupuncture could be a viable treatment for OAB in women, but there is a lack of high-quality clinical evidence. This study aims to evaluate the effectiveness of electroacupuncture as a safe and efficient non-pharmacological treatment for female OAB by comparing it with solifenacin succinate. METHODS AND ANALYSIS: This study is a multicentre, single-blind, double-dummy randomised controlled non-inferiority clinical trial involving 204 eligible female participants with OAB. Participants will be randomly assigned in a 1:1 ratio to either the electroacupuncture group (receiving electroacupuncture and placebo) or the solifenacin succinate group (receiving sham electroacupuncture and solifenacin succinate). Each participant will undergo 12 sessions of electroacupuncture (or sham electroacupuncture) treatment and solifenacin succinate (or placebo) treatment over a 4-week period. The primary outcome measure will be the percentage change in the number of micturition episodes every 24 hours at week 4 compared with baseline. Secondary outcomes will include a percentage reduction in the number of micturition episodes every 24 hours at 2th, 8th and 16th weeks of the trial, Overactive Bladder Symptom Score, number of urinary incontinence and urgency episodes every 24 hours based on a 3-day voiding diary, OAB Questionnaire, Generalised Anxiety Disorder Scale-7, King's Health Questionnaire and Participant Self-evaluation of Therapeutic Effects. Adverse events will be monitored throughout the study. Efficacy analyses will be conducted on both the intention-to-treat population and the per-protocol set population. ETHICS AND DISSEMINATION: Ethical approval has been obtained from the Medical Ethics Committee of Longhua Hospital Shanghai University of Traditional Chinese Medicine (approval number: 2022LCSY097). Each participant will sign a written informed consent before randomisation. The results of this study will be published in a peer-reviewed journal. TRIAL REGISTRATION NUMBER : NCT05798403.

Optimized electroacupuncture treatment for female stress urinary incontinence: study protocol for a multi-center randomized controlled trial.

Background: Stress urinary incontinence (SUI) is a common condition that can severely affect women's life quality. Electroacupuncture (EA) has been proved to be an optional treatment for SUI, but the tolerance of EA becomes a factor affecting efficiency, which should not be ignored and needs to be solved urgently. The purpose of this study is to find out whether the use of alternating acupoints combination can solve this problem or not and provide an optimization of EA treatment for female SUI. Methods: This multi-center randomized controlled trial will enroll 360 patients with SUI. They will be randomly assigned to one of the three groups-sacral acupoints group (sacral group), abdominal acupoints group (abdominal group), or alternating acupoints group (alternating group)-at a 1:1:1 ratio. The patients will receive 18 sessions of EA treatment and will be followed up for 48 weeks after the treatment. The primary outcome measure of the study is the change of urine leakage at week 6. The secondary outcomes include the incontinence episode frequency (IEF), International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF), severity of SUI, patient self-evaluation of therapeutic effects, weekly usage of urine pads, ultrasonography of pelvic floor, specialty therapies for SUI, evaluation of discomfort during EA treatment, patient acceptability evaluation and adverse events related to intervention. Discussion: This trial is specifically designed to offer an optimized EA treatment for female SUI, aiming to enhance their quality of life.Clinical trial registration: ClinicalTrials.gov, identifier ID:NCT05635669.

Identifying immune cell infiltration and effective diagnostic biomarkers in Crohn's disease by bioinformatics analysis.

Background: Crohn's disease (CD) has an increasing incidence and prevalence worldwide. It is currently believed that both the onset and progression of the disease are closely related to immune system imbalance and the infiltration of immune cells. The aim of this study was to investigate the molecular immune mechanisms associated with CD and its fibrosis through bioinformatics analysis. Methods: Three datasets from the Gene Expression Omnibus data base (GEO) were downloaded for data analysis and validation. Single sample gene enrichment analysis (ssGSEA) was used to evaluate the infiltration of immune cells in CD samples. Immune cell types with significant differences were identified by Wilcoxon test and Least Absolute Shrinkage and Selection Operator (LASSO) regression analysis. Differentially expressed genes (DEGs) were screened and then subjected to Gene Ontology (GO) and Kyoto Encyclopedia of Genes and Genomes (KEGG) functional correlation analysis, as well as protein-protein interaction (PPI) network analysis. The cytoHubba program and the GSE75214 dataset were used to screen for hub genes and plot Receiver operating characteristic (ROC)curves to screen for possible biomarkers of CD based on diagnostic efficacy. The hub genes of CD were correlated with five significantly different immune cells. In addition, validation was performed by real time quantitative PCR (RT-qPCR) experiments in colonic tissue of CD intestinal fibrosis rats to further identify hub genes that are more related to CD intestinal fibrosis. Results: The DEGs were analyzed separately by 10 algorithms and narrowed down to 9 DEGs after taking the intersection. 4 hub genes were further screened by the GSE75214 validation set, namely COL1A1, CXCL10, MMP2 and FGF2. COL1A1 has the highest specificity and sensitivity for the diagnosis of CD and is considered to have the potential to diagnose CD. Five immune cells with significant differences were screened between CD and health controls (HC). Through the correlation analysis between five kinds of immune cells and four biomarkers, it was found that CXCL10 was positively correlated with activated dendritic cells, effector memory CD8+ T cells. MMP2 was positively correlated with activated dendritic cells, gamma delta T cells (γδ T) and mast cells. MMP2 and COL1A1 were significantly increased in colon tissue of CD fibrosis rats. Conclusion: MMP2, COL1A1, CXCL10 and FGF2 can be used as hub genes for CD. Among them, COL1A1 can be used as a biomarker for the diagnosis of CD. MMP2 and CXCL10 may be involved in the development and progression of CD by regulating activated dendritic cell, effector memory CD8+ T cell, γδ T cell and mast cell. In addition, MMP2 and COL1A1 may be more closely related to CD intestinal fibrosis.

Comparative study of two different rat models of stress urinary incontinence.

INTRODUCTION AND HYPOTHESIS: The purpose of this study was to compare the success rate and urodynamic characteristics of the rat model of stress Urinary incontinence established by ovariectomy at different times after vaginal dilation. METHODS: Eighty female rats were randomly divided into three groups: the control group (n = 20), model group A (n = 30), i.e., the animals received colpectasis and bilateral oophorectomy within 1 day; model group B (n = 30), i.e., the animals received bilateral oophorectomy 1 week after colpectasis. The sneeze test and urodynamics were tested. RESULTS: There was no significant difference between the model group A and the model group B (p > 0.05) in the sneeze test. The leak point pressure (LPP) of model groups A and B was lower than that of the control group (p < 0.05). The LPP value of model group A was lower than that of model group B (p < 0.05). There was no significant difference in maximum bladder capacity (MBC) between model group A and the control group (p > 0.05); the MBC value of model group B was lower than that of the control group and model group A (p < 0.05). CONCLUSIONS: Models of stress urinary incontinence in rats can be successfully established by both modeling methods. In terms of LPP, model groups A and B had lower values than the control group, and model group A had lower values than model group B. In terms of MBC, there was no difference between model group A and the control group, and model group B had lower values than the control group and model group A.

Effect of electroacupuncture on the intestinal microflora in rats with stress urinary incontinence.

Objective: To examine the effect of electroacupuncture on the urodynamics and gut microbiota of rats with stress urinary incontinence (SUI). Materials and methods: Thirty 2-month-old female Sprague-Dawley (SD) rats were randomly assigned to 4 groups: normal (N), model (M), nonacupoint electric acupuncture control (NAAC), and electroacupuncture (EA). An SUI rat model was established through vaginal balloon dilatation and bilateral oophorectomy. After various treatments, urodynamic tests were performed, and feces were collected. 16S rRNA sequencing analysis was used to investigate SUI-related changes in the intestinal flora. Results: After treatment, compared with those of the M group, the leak point pressure and maximum bladder capacity of the electroacupuncture groups increased (P<0.05). The species community compositions of the N and M groups differed at the genus level, and there were 15 differentially abundant bacterial genera (P<0.05). The Blautia proportion was increased by electroacupuncture treatment (P<0.05) and was significantly positively correlated with the electroacupuncture treatment of SUI (according to Spearman correlation analysis). Conclusion: Electroacupuncture treatment can improve signs of urine leakage in rats with SUI rats by increasing the leak point pressure and maximum bladder capacity. The enrichment of Blautia by electroacupuncture treatment enrichment may be related to SUI sign improvement.

Effect of electroacupuncture on the degradation of collagen in pelvic floor supporting tissue of stress urinary incontinence rats.

INTRODUCTION AND HYPOTHESIS: To examine the changes induced by electroacupuncture in stress urinary incontinence (SUI) rats, including the urodynamics and collagen degradation-related cytokine molecular biological expression changes, and to explore the effect and mechanism of EA treatment in SUI. METHODS: Female SPF Sprague-Dawley rats were randomly assigned to five groups (n = 10): sham, model, electroacupuncture control, electroacupuncture, and blocker. The leak point pressure (LPP) and maximum bladder capacity (MBC) were measured for each group of rats, and collagen I, collagen III, matrix metalloproteinases (MMPs), and tissue inhibitor of metalloproteinase (TIMPs) in the anterior vaginal wall of rats in each group were determined by reverse transcription-polymerase chain reaction and western blotting. The data were analyzed by one-way analysis of variance or Kruskal-Wallis test. RESULTS: Electroacupuncture Shenshu (BL23) and Huiyang (BL35) increased the LPP and MBC in SUI rats (P < 0.05). Electroacupuncture treatment significantly increased the protein expression of collagen I and collagen III in the anterior vaginal wall of SUI rats (P < 0.05) and significantly reduced the protein expression of MMP1, MMP2, and MMP9 (P < 0.05). CONCLUSIONS: Electroacupuncture stimulation can alleviate the signs of SUI, and its mechanism is related to the degradation of collagen in the anterior vaginal wall.

[Acupuncture at xing-spring point, shu-stream point and lower he-sea point for type-2 diabetic peripheral neuropathy].

OBJECTIVE: To observe the effect of acupuncture at xing-spring point, shu-stream point and lower he-sea point on neurological function and clinical symptoms in patients with type-2 diabetic peripheral neuropathy. METHODS: Sixty patients with type-2 diabetic peripheral neuropathy were randomly divided into an observation group and a control group, 30 cases in each one. Both groups were treated with basic treatment, and the observation group was additionally treated with acupuncture at Neiting (ST 44), Xiangu (ST 43), Dadu (SP 2), Taibai (SP 3), Zusanli (ST 36), etc. once every other day, 3 times a week for 4 weeks. The changes of TCM symptom score, Toronto clinical assessment (TCSS) score, visual analogue scale (VAS) score of pain and serum tumor necrosis factor α(TNF-α) level were observed before and after treatment in the two groups, and the clinical effects of the two groups were evaluated. RESULTS: Compared before treatment, the TCM syndrome score and the TCSS score in the two groups were reduced after treatment (P<0.05), and the TCM syndrome score after treatment in the observation group was lower than that in the control group (P<0.05). After treatment, the VAS in the observation group was reduced (P<0.05), and the VAS score of pain in the observation group was lower than that in the control group (P<0.05). There was no significant difference in the level of serum TNF-α within and between the two groups (P>0.05). The total effective rate was 76.7% (23/30) in the observation group, which was superior to 33.3% (10/30) in the control group (P<0.05). CONCLUSION: Acupuncture at xing-spring point, shu-stream point and lower he-sea point could effectively improve the neurological function and clinical symptoms in patients with type-2 diabetic peripheral neuropathy.

Immediate effects of Zhongji point acupuncture on pelvic floor structure in female patients with stress urinary incontinence: a randomized, single-blind, and sham-controlled clinical trial protocol.

BACKGROUND: Stress urinary incontinence (SUI) is defined as involuntary leakage of urine from the external urethra due to increased abdominal pressure, for example, upon sneezing, coughing, or exercise. Acupuncture is an effective therapy for patients with SUI, although objective evidence of its benefits or mechanism of action is limited. Patients with SUI often harbor structural changes of pelvic floor, the parameters of which are measurable from various perspectives and in multiple dimensions, dynamically and comprehensively, through transperineal ultrasound (TPUS). The status of such changes may then be assessed following acupuncture procedures. In the present investigation, TPUS serves to gauge the immediate effects of acupuncture on pelvic floor structures in female patients with SUI. METHODS: This protocol calls for a prospective, randomized, controlled, and single-blinded study of 72 female patients with SUI, each randomly assigned as test or control group members. The test group is subjected to one-time acupuncture at the Zhongji (RN3) acupoint for a period of 10 min, whereas the control group undergoes sham acupuncture in the same manner. In both groups, TPUS imaging of pelvic floor is performed before, during, and immediately after acupuncture procedures. Bladder neck mobility (BND), urethral rotation angle (URA), retrovesical angle (RVA), lowest point of bladder (BN-S), and presence/absence of urethral funneling or bladder bulging are then recorded as outcome measures. DISCUSSION: Above efforts are intended to assess real-time pelvic floor structural changes in women undergoing acupuncture for SUI. The subsequent findings may help objectively document the efficacy of acupuncture in this setting and clarify its mechanism of action. TRIAL REGISTRATION: Registration with the Chinese Clinical Trial Registry (ChiCTR200041559) (http://www.chictr.org.cn/edit.aspx?pid=64591&htm=4), was effective December 29, 2020. DATES OF STUDY: 12/19/2020 to 06/30/2022.

[The experimental study of culture in vitro of fibroblasts seeded onto human amnion extracellular matrix (HA-ECM)].

OBJECTIVE: The aim of this experiment is to find proper cell carrier for skin tissue engineering. METHODS: Various concentration of fibroblasts were seeded onto HA-ECM and cultured in vitro. The performance of cells' growth, array, adhesion and collagen secretion on HA-ECM was observed with light microscope and transmission electron microscope. RESULTS: The fusiform fibroblasts oriented radiantly or longitudinally and closely packed onto the HA-ECM, they attached firmly and proliferated to confluence on the stromal surface of HA-ECM. CONCLUSION: The optimal cell concentration is 3.5 x 10(6)/ml, HA-ECM is ideal carrier for fibroblasts because of its excellent scaffold and diffusion characteristics. Futhermore, it has the bioactive molecules such as fibronectin and laminin which play an important role in fibroblasts attachment and proliferation on HA-ECM.

Repair of flexor tendon defects of rabbit with tissue engineering method.

OBJECTIVE: To repair rabbit tendon defects with tissue engineering method. METHODS: The third passage of fetal skin fibroblast cells was labeled with 5-bromo-2' deoxyuridine (Brdu) and then seeded on human amnion extracellular matrix (HA-ECM). Using 1 cm-long-Achilles tendon defects as repairing models in the experimental group, tendon defects were core bridged with polydioxanone (PDS) and then capsulated with the complex of fibroblasts-HA-ECM. In the control group I, defective tendons were sutured with PDS following the former procedure and capsulated with HA-ECM (without fibroblasts). In the control group II, only PDS was applied to connect the defective tendons. Gross examination, light microscopy, scanning electronmicroscopy and biomechanical measurement of the repaired tendons were respectively performed at postoperative 1, 2, 3 month as well as immunohistochemical examination. RESULTS: The optimal cell concentration for seeding fibroblasts was 3.5 x 10(6) cells/ml. Cells grew well and radiated or paralleled on HA-ECM. Immunohistochemistry showed that the labeled seed fibroblasts played an important role in tendonization. The results of light microscopy, electron microscopy, and biomechanical assessment suggested that the rate and quality of tendonization in the experimental group was superior to those of the control group I and II. The tensile strength in the experimental group was the greatest, the next was in the control group I, and the worst in the control group II (P<0.05). CONCLUSIONS: HA-ECM is the excellent carrier for fibroblasts. Fibroblasts-HA-ECM complex has the capability to repair tendon defect and to tendonize with rapid rate and good performance three months after operation. Its tensile strength is 81.8% of that of normal tendon.