Acupuncture relieves menopausal discomfort in breast cancer patients: A prospective,double blinded,randomized study

BackgroundThis study evaluates the effect of acupuncture on hot flashes and disturbed night sleep in patients treated for breast cancer. The effect of acupuncture was tested against a sham-acupuncture group and a no-treatment control group. Plasma estradiol was measured to rule out this as cause of effect. Side effects of the treatment were registered.MethodsWe randomized 94 women into the study: 31 had acupuncture, 29 had sham acupuncture and 34 had no treatment.FindingsIn the acupuncture group, 16 patients (52%) experienced a significant effect on hot flashes compared with seven patients (24%) in the sham group (p < 0.05). The effect came after the second acupuncture session and lasted for at least 12 weeks after last treatment. A statistically significant positive effect was seen on sleep in the acupuncture group compared with the sham-acupuncture and no-treatment groups. The effect was not correlated with increased levels of plasma estradiol. No side effects of acupuncture were registered.InterpretationWe find that acupuncture significantly relieves hot flashes and sleep disturbances and is a good and safe treatment in women treated for breast cancer.The project is registered at Clinical Trials.gov (no: NCT00425776).     

Randomized, double-blind, placebo-controlled, crossover study of sertraline (Zoloft) for the treatment of hot flashes in women with early stage breast cancer taking tamoxifen

We observed the relief of hot flashes in breast cancer survivors taking tamoxifen and treated with sertraline for depression. Our objective was to assess the effect of sertraline on the frequency and severity of hot flashes, mood status, and health-related quality of life. We used a randomized, double-blind, placebo-controlled, crossover study using 6 weeks of sertraline (50 mg each morning) versus placebo. Study participants were 62 breast cancer survivors from an oncology clinic in a tertiary care center on adjuvant tamoxifen reporting bothersome hot flashes. Patients were asked to keep a daily hot flash diary to record hot flash frequency and severity, from which hot flash scores (frequency x severity) were calculated. The Center for Epidemiologic Studies depression scale and Functional Assessment of Cancer Therapy--Breast (FACT-B) (at baseline, 6 weeks, and 12 weeks) were used to assess mood and quality of life. Sixty-two women were accrued. Forty-seven women (median age 53.9 years, range 36.6-77.1 years; 89% postmenopausal; 85.5% Caucasian) completed the first 6 weeks and 39 completed 12 weeks. The baseline daily hot flash frequency and score were 5.8 (standard deviation 4.1) and 11.5 (14.0), respectively. At the end of the first 6 weeks, hot flash frequency decreased by 50% in 36% of those taking sertraline compared to 27% taking placebo. In the crossover analysis, sertraline was significantly more effective than placebo: women crossing from placebo to sertraline had a decrease (-0.9 and -1.7) in hot flash frequency and score, whereas those crossing from sertraline to placebo had an increase (1.5 and 3.4) in hot flash frequency and score (p = 0.03 and 0.03). Forty-eight percent preferred the sertraline period, 11% preferred the placebo period, and 41% had no preference (p = 0.006). Measures of depression and quality of life were within normal range and did not change significantly within treatment groups. Sertraline decreases hot flashes in breast cancer survivors taking tamoxifen and women prefer sertraline to placebo. Further study of sertraline for the management of hot flashes is warranted.     

Carpal tunnel syndrome treated with guided brain plasticity: a randomised,controlled study

Introduction: Guided plasticity, induced by cutaneous forearm anaesthesia, improves hand sensibility in patients with nerve injury and vibration-induced neuropathy. This study investigated whether patients with carpal tunnel syndrome (CTS) would benefit from cutaneous forearm anaesthesia.

Methods: Seventy patients with clinical and electroneurography-verified CTS were randomised to sensory training combined with either an anaesthetic cream (EMLA^®) (n?=?34) or a placebo cream (n?=?36) on the volar part of the forearm. The treatment was repeated at increasing intervals over 8 weeks. The primary outcome was the Boston carpal tunnel questionnaire (BCTQ) symptom severity scale after 8 weeks. Secondary outcomes included activity limitations, sensory function, and nerve conduction. This study compared the longitudinal changes between the two groups, and with correction for multiple comparisons it also compared the longitudinal change within the groups.

Results: There were no significant differences in primary or secondary outcomes between the groups. However, the BCTQ symptom severity scale improved significantly within the EMLA^® group over the 8-week period (p?=?0.001). Apart from this, no significant improvements in activity limitations, sensory function, or nerve conduction were seen in the two groups compared to baseline. Altogether, 47% of patients in the EMLA^® group and 61% in the placebo group had been operated on with carpal tunnel release by 12 months.

Conclusion: An 8-week treatment protocol with cutaneous forearm anaesthesia to guide brain plasticity gave no significant subjective or objective improvements in hand function compared to placebo.     

Shockwave therapy for chronic Achilles tendinopathy: A double-blind,randomized clinical trial of efficacy

Background and purpose?Chronic Achilles tendinopathy is a painful condition and there are often unsatisfactory results with conservative treatment. Extracorporal shock-wave therapy (ESWT) has been introduced for the management of various soft tissue conditions. The objective of the study was to compare the effect of supplementing conservative treatment of chronic Achilles tendinopathy with ESWT or placebo.

Patients and methods?This was a randomized, double-blind, placebo-controlled trial. Patients assigned to nonoperative treatment of chronic achilles tendinopathy were randomized to receive either active ESWT or sham ESWT over 4 weeks. There were 48 patients (28 men) with a mean age of 47 (19–80) years. American Orthopaedic Foot and Ankle Society (AOFAS) score and pain were assessed before treatment, during the 4-week treatment period, and at 4, 8, and 12 weeks of follow-up.

Results?Both groups improved during the treatment and follow-up period. The mean AOFAS score increased from 74 (SD 12) to 81 (16) in the placebo group and from 70 (6.8) to 88 (10) in the intervention group (p = 0.05). Better results were seen in the intervention group at 8 and 12 weeks of follow-up (p = 0.01 and p = 0.04, respectively).

Interpretation?Extracorporal shock-wave therapy appears to be a supplement for the treatment of chronic Achilles tendinopathy.     

Hot flashes in breast cancer survivors: Frequency,severity and impact

PurposesTo (1) determine the frequency and severity of hot flashes, (2) examine the associations between hot flash frequency and severity and quality of life, and (3) identify the predictors of hot flash activity in breast cancer survivors.MethodsThe study used a cross-sectional design and mailed survey of 253 breast cancer survivors recruited from a cancer wellness clinic. Participants provided information regarding cancer history, hot flashes, pain intensity, sleep problems, physical functioning, and psychological functioning.ResultsAbout half of the survivors reported at least one hot flash in the past 24 h (45%) or past week (52%). The average frequency of hot flashes was 1.9 in the past 24 h and 1.8 in the past week. Hot flash severity was usually mild or asymptomatic. However, participants with hot flashes reported significantly more sleep problems and higher pain severity than those reporting no hot flashes. Moreover, the severity of hot flashes was associated with more sleep problems, higher pain severity, and more psychological dysfunction. History of hormonal suppression therapy and younger age predicted hot flash activity in the study sample.ConclusionsIn breast cancer survivors, hot flashes are common and are associated with unpleasant symptoms and poor quality of life. Research is needed to determine if treatments that reduce the frequency and severity of hot flashes in breast cancer survivors also result in improvements in symptoms such as sleep problems, pain, and psychological dysfunction.     

Changes in overactive bladder symptoms after discontinuation of successful 3-month treatment with an antimuscarinic agent: a prospective trial

Purpose:We measured changes in overactive bladder (OAB) symptoms after the discontinuation of successful 3-month treatment with an antimuscarinic agent and the pretreatment factors that contributed to re-treatment.Materials and Methods:A total of 68 women who reported improvement in OAB symptoms after 4 weeks of treatment with 20 mg propiverine hydrochloride daily were prospectively enrolled in a protocol consisting of 8 more weeks of medication and a 4-week discontinuation period. Frequency-volume charts were assessed before treatment, after 12 weeks of therapy and 4 weeks after discontinuation along with a questionnaire assessing satisfaction with treatment and desire for further treatment. The Indevus Urgency Severity Score was used to quantify the degree of urgency and changes during treatment. Changes in frequency, nocturia, and urgency score at 12 and 16 weeks were evaluated. Pretreatment factors leading to re-treatment were determined, including patient characteristics, voiding symptom parameters and urodynamic indexes.Results:OAB symptoms at 16 weeks (4 weeks after the cessation of antimuscarinic medication) were improved compared with baseline but worse than after 12 weeks. At baseline, and 12 and 16 weeks mean daily frequency was 11.2, 7.3 and 8.3, mean nocturia frequency was 1.6, 0.4 and 0.8, and the urgency score was 1.7, 0.6 and 1.2, respectively. The re-treatment rate was 35.3%. Patients in the re-treatment group were significantly older (58.8 vs 47.3 years, p <0.001) and had higher initial urgency scores (1.9 vs 1.6, p = 0.034) than those requiring no further treatment. Of 23 patients who underwent a urodynamic study those without detrusor overactivity (DO) maintained significant improvement regarding frequency after cessation of medication, whereas those with DO did not, although their frequency was improved compared with baseline (p = 0.02). The re-treatment rate was higher in patients with DO but the difference was not statistically significant (60.9% vs 39.1%, p = 0.45).Conclusions:Of patients 35% sought re-treatment 1 month after the discontinuation of antimuscarinic therapy. Patients older than 55 years or those with severe urgency may more frequently receive re-treatment and patients with DO may experience more rapid symptom recurrence after medication discontinuation.     

Clinical outcomes comparison of distal radius fractures between two conservative treatment methods: Below-arm cast versus reverse sugar tong splint

BackgroundThe purpose of this prospective randomized study was to compare a new reverse sugar tong splint technique with a below-arm cast, in terms of patient radiological and clinical outcomes.MethodsOne hundred and forty patients who presented to our clinic between April 2017 and March 2019 were randomly divided into two groups: 70 received reverse sugar tong (RST group) and 70 received below arm cast (BAC group). Clinical and radiological follow-up was performed 7–10 days, three weeks, 5 or 6 weeks, 12 weeks and one year after the treatment. Clinical outcomes including wrist range of motion, complication rates, Health Assessment Questionnaire (HAQ) score at end of treatment, Disabilities of the Arm, Shoulder, and Hand (Q-DASH) questionnaire and Mayo Elbow Performance score (MEPS) score at 12 weeks and last follow-up.ResultsFinally, sixty-five patients were treated with BAC, and their average age was 58.2 years and sixty-two patients with an average age of 57.4 years were treated with RST were completed the radiological and clinical one-year follow-up. There were no significant differences in range of motion, radiological parameters, the Q-DASH and MEPS scores between the groups the 12th week and last visit; however, the HAQ score was significantly higher in the cast group during the 6th visit (p < 0.001). The BAC group had a higher complication rate (40%) than the RST group (19.3%) (p = 0.01).ConclusionPatient treated with RST had a higher functional status at end of treatment and lower complications when comparing traditional below arm cast.Level of evidenceLevel I prognostic randomized controlled trial.     

Intensive preoperative ostomy education for the radical cystectomy patient

ObjectivesPatients undergoing radical cystectomy with ileal conduit formation usually receive training on the use of their stoma during their initial hospitalization – while actively recovering from surgery – often with little follow-up or reinforcement. Many of these patients are not equipped to deal with these significant body changes, which can lead to additional clinic visits, stoma-related complications, and decreased patient satisfaction/health-related quality of life (HRQOL). In an effort to improve patient education, we sought to evaluate the feasibility of implementing a preoperative comprehensive stoma education session termed the “stoma bootcamp” for patients scheduled for a radical cystectomy and ileal conduit (RCIC). We tracked patient related outcomes to determine its impact.MethodsWe performed a longitudinal, quality-improvement feasibility study at the University of Kansas Health System. All patients who were scheduled to undergo a RCIC for bladder cancer were offered enrollment into the study at their preoperative clinic visit. The “stoma boot camp” consisted of a 3-hour group session within 2 weeks of the surgery date. Patients were given a short presentation by residents and advanced practice providers regarding the operation, recovery, and expectations for their post-operative care. Ostomy nurses then demonstrated basic urostomy care – pouching, sizing, emptying – along with trouble-shooting tips for common ostomy problems. Measurements of HRQOL questionnaires were completed at the initial visit, after “boot camp,” and at defined time points after surgery for 12 weeks. This included using an ostomy adjustment score. Length of stay, unplanned stoma-related interventions, and re-admissions within 30 days were also tracked.ResultsIn this initial pilot program, 51 patients participated in the stoma bootcamp. The patients had an average ostomy adjustment score (OAS) of 150.4 (95% CI 142.0, 158.8) at discharge from the hospital, and these high OAS levels persisted throughout the 12 weeks of follow-up data without any significant decline. Short-form 36 (SF-36) scores demonstrated numerical improvements in each individual category at the 6-week mark above baseline. These improvements persisted at the 12-week mark.ConclusionsIn this study we were able to establish the feasibility of implementing a preoperative comprehensive stoma education session for patients scheduled for a RCIC. Additionally, we were able to document favorable HRQOL data and improved ostomy adjustment scores surrounding the education session.     

Commentary on “Phase II trial of cetuximab with or without paclitaxel in patients with advanced urothelial tract carcinoma.” Wong YN,Litwin S,Vaughn D,Cohen S,Plimack ER,Lee J,Song W,Dabrow M,Brody M,Tuttle H,Hudes G,University of Pennsylvania,Philadelphia, PA: J Clin Oncol 2012;30(28):3545–51 [Epub 2012 Aug 27]

PurposeThe benefit of salvage chemotherapy is modest in metastatic urothelial cancer. We conducted a randomized, noncomparative phase II study to measure the efficacy of cetuximab with or without paclitaxel in patients with previously treated urothelial cancer.Patients and MethodsPatients with metastatic urothelial cancer who received one line of chemotherapy in the perioperative or metastatic setting were randomly assigned to 4-week cycles of cetuximab 250 mg/m(2) with or without paclitaxel 80 mg/m(2) per week. We used early progression as an indicator of futility. Either arm would close if seven of the initial 15 patients in that arm progressed at the first disease evaluation at 8 weeks.ResultsWe enrolled 39 evaluable patients. The single-agent cetuximab arm closed after nine of the first 11 patients progressed by 8 weeks. The combination arm completed the full accrual of 28 patients, of whom 22 patients (78.5%) had visceral disease. Twelve of 28 patients had progression-free survival greater than 16 weeks. The overall response rate was 25% (95% CI, 11% to 45%; three complete responses and four partial responses). The median progression-free survival was 16.4 weeks (95% CI, 12 to 25.1 weeks), and the median overall survival was 42 weeks (95% CI, 30.4 to 78 weeks). Treatment-related grade 3 and 4 adverse events that occurred in at least two patients were rash (six cases), fatigue (five cases), and low magnesium (three cases).ConclusionAlthough it had limited activity as a single agent, cetuximab appears to augment the antitumor activity of paclitaxel in previously treated urothelial cancers. The cetuximab and paclitaxel combination merits additional study to establish its role in the treatment of urothelial cancers.     

Prospective evaluation of hot flashes during treatment with parenteral estrogen or complete androgen ablation for metastatic carcinoma of the prostate.

PURPOSE: We evaluated the incidence and frequency of, and distress due to hot flashes after castration therapy with polyestradiol phosphate and complete androgen ablation. MATERIALS AND METHODS: A total of 915 men with metastatic prostate carcinoma enrolled in the Scandinavian Prostatic Cancer Group-5 trial study were randomized to intramuscular injections of 240 mg. Polyestradiol phosphate every 2 weeks for 8 weeks followed by monthly subcutaneous injections or complete androgen ablation, that is bilateral orchiectomy or 3.75 mg. of the gonadotropin-releasing hormone analog triptorelin monthly combined with 250 mg. of the antiandrogen flutamide 3 times daily. The incidence and frequency of, and distress due to hot flashes were recorded at regular intervals using a questionnaire. RESULTS: Of the 915 men 901 were evaluated at a median followup of 18.5 months. The incidence of hot flashes was 30.1% and 74.3% in the polyestradiol phosphate and complete androgen ablation groups, respectively (p <0.001). In the polyestradiol phosphate group the frequency of and distress due to hot flashes were significantly lower than in the androgen ablation group. There was complete relief from hot flashes in 50% of the men on polyestradiol phosphate during followup compared with none on androgen ablation. The incidence of hot flashes did not differ in men with and without tumor progression. CONCLUSIONS: Endocrine treatment with polyestradiol phosphate induced fewer and less distressing hot flashes than complete androgen ablation. Flashes also disappeared to a greater extent during polyestradiol phosphate than during androgen ablation. The data in this study enable us to provide thorough individual information to patients on the risk and grade of expected distress and duration of hot flashes during polyestradiol phosphate or complete androgen ablation treatment.     

Pentosan polysulfate sodium therapy for men with chronic pelvic pain syndrome: a multicenter, randomized, placebo controlled study

Purpose:We evaluated the efficacy and tolerability of pentosan polysulfate sodium (PPS) for the treatment of men with chronic pelvic pain syndrome (CPPS), National Institutes of Health (NIH) category III.Materials and Methods:In a 16-week double-blind study 100 men with a clinical diagnosis of CPPS were randomized to receive 300 mg PPS or placebo 3 times daily. Clinical Global Improvement (CGI) was the primary outcome measure. Additional outcome measures were the NIH-Chronic Prostatitis Symptom Index (CPSI), Subjective Global Assessment and Symptom Severity Index assessment tools.Results:Significantly more patients receiving PPS experienced moderate to marked improvement based on CGI assessment (18 or 37% vs 8 or 18%, p = 0.04). However, mean CGI scores were not significantly different between the PPS group (1.0) and placebo groups (1.0 vs 0.6, p = 0.107). All NIH-CPSI domains suggested a positive effect for PPS and for total NIH-CPSI the difference approached statistical significance (−5.9 or 22% vs −3.2 or 12%, p = 0.068). The PPS group showed significantly greater improvement in NIH-CPSI quality of life domain scores than the placebo group (−2.0 or 22% vs −1.0 or 12%, p = 0.031). Of patients receiving PPS 67% and 80% of those receiving placebo completed the 16-week study. Diarrhea, nausea and headache were the most common adverse events.Conclusions:Pentosan polysulfate (900 mg daily) was more likely than placebo to provide relief for CPPS symptoms.     

Ivacaftor in cystic fibrosis with residual function: Lung function results from an N-of-1 study

BackgroundIvacaftor shows benefit in patients with cystic fibrosis (CF) and CFTR mutations associated with residual CF transmembrane conductance regulator (CFTR) function. Here we further assess the effect of ivacaftor in such patients using an N-of-1 study design.MethodsPatients aged ≥12 years with CF with clinical or molecular evidence of residual CFTR function were randomized to 1 of 4 treatment sequences for two 4-week, double-blind crossover cycles (each divided into 2 weeks of ivacaftor treatment and placebo) followed by 8 weeks of open-label ivacaftor treatment. The primary endpoint was absolute change from cycle baseline of percent predicted forced expiratory volume in 1 s (ppFEV₁) after 2 weeks of treatment with ivacaftor relative to placebo.ResultsAbsolute change (SD) from study baseline in ppFEV₁ favored ivacaftor by 2.3 (1.0) percentage points (95% credible interval, 0.4–4.1) after 2 weeks of treatment. Absolute mean change (SD) from open-label baseline (defined as day 1 of the open-label ivacaftor treatment period) in ppFEV₁ after 8 weeks of treatment was 4.7 (4.2) percentage points (P<.0001). Safety of ivacaftor was consistent with that observed in prior studies.ConclusionsIvacaftor improved lung function during the double-blind and open-label treatment periods in patients with CF and CFTR mutations associated with residual CFTR function (ClinicalTrials.gov, NCT01685801).     

The effect of locally delivered recombinant human bone morphogenetic protein-2 with hydroxyapatite/tri-calcium phosphate on the biomechanical properties of bone in diabetes-related osteoporosis

BackgroundRecombinant human bone morphogenetic protein-2 (rhBMP-2) is particularly effective in improving osteogenesis in patients with diminished bone healing capabilities, such as individuals with type 1 diabetes mellitus (T1DM) who have impaired bone healing capabilities and increased risk of developing osteoporosis. This study measured the effects of rhBMP-2 treatment on osteogenesis by observing the dose-dependent effect of localized delivery of rhBMP-2 on biomechanical parameters of bone using a hydroxyapatite/tri-calcium phosphate (HA/TCP) carrier in a T1DM-related osteoporosis animal model.ResultsAt the 4-week time point, the LD and HD groups both exhibited significantly higher BMD than controls; at the 8-week time point, the HD group exhibited significantly higher BMD than controls. Biomechanical testing revealed dose-dependent, higher trends in all parameters tested at the 4- and 8-week time points, with minimal significant differences.ConclusionsGroups treated with rhBMP-2 demonstrated improved bone mineral density at both 4 and 8 weeks compared to control saline groups, in addition to strong trends towards improvement of intrinsic and extrinsic biomechanical properties when compared to control groups. Data revealed trends toward dose-dependent increases in peak torque, torsional rigidity, shear stress, and shear modulus 4 weeks after rhBMP-2 treatment.

Level of evidence

Not applicable.     

Epirubicin-loaded beads transarterial prostatic arterial chemoembolization is a promising treatment for advanced prostate cancer with lower urinary tract obstruction or hematuria—a case series report

BackgroundProstatic arterial embolization (PAE) is an effective minimally invasive treatment for lower urinary tract obstruction and hematuria in patients with benign prostatic hyperplasia (BPH). This study was aim to evaluate the safety and short-term efficacy of drug epirubicin-loaded beads transarterial prostatic arterial chemoembolization (DEB-PACE) for the treatment of advanced prostate cancer (PC) with lower urinary tract obstruction or hematuria.MethodsA total of 8 patients with advanced PC undergoing DEB-PACE from August 2020 to February 2022 were retrospectively enrolled. The patients were followed up at 1 week, 1, 3, 6 and 12 months after DEB-PACE. The origin of prostatic arteries, technical success, clinical success rate, duration of the indwelling urinary catheter, International Prostate Symptom Score (IPSS), QoL score (quality of life), prostate volume (PV), prostate-specific antigen (PSA) level and complications were recorded. The short-term efficacy (changes in IPSS, PV and QoL value from baseline to 3 months) were analysed.ResultsThere were 17 prostatic arteries in 8 patients, which mainly originated from internal pudendal artery (11/17, 64.7%), the technical success rate is 100%. After treatment, the symptoms of lower urethral obstruction in 8 patients were significantly improved that PSA, PV, IPSS and QoL level were significantly reduced. The catheter was successfully removed within 1 week on average, and 2 patients with hematuria disappeared within 5 days. The clinical success rate is 100%. At 1 month postoperatively, mean PV reduction was 30.28±6.963 cm³ (P=0.0457), mean IPSS reduction was 21.13±2.887 points (P=0.0042), mean QoL reduction was 3.75±0.366 points (P=0.006). At 3 months postoperatively, mean PV reduction was 46.14±8.906 cm³ (P=0.0112), mean IPSS reduction was 24.5±2.398 points (P=0.0003), mean QoL reduction was 4.25±0.25 points (P=0.0003). There were no serious complications occurred in all patients.ConclusionsDEB-PACE is a promising treatment for advanced PC with lower urinary tract obstruction or hematuria. However, the efficacy and safety of DEB-PACE for advanced PC is needed to validated by prospective large sample randomized controlled study.     

Does diabetes affect functional outcomes after shoulder arthroplasty?

ObjectivesThe purpose of this study was to assess whether diabetes affects functional and physical outcomes following shoulder arthroplastyMethodsA cohort of 140 patients were tested preoperatively, at an early follow-up visit (between 3-6 months) and at late follow-up visit (between 1-3 years) following shoulder arthroplasty. The American Shoulder and Elbow Surgeons (ASES) Standardized Shoulder Assessment Form measured shoulder pain and function and the Short-Form-12 (SF-12) measured physical health status. Shoulder goniometry and dynamometry were used to assess motion and strength. Diabetic status was self-reported.ResultsThere were significant improvements in function and physical health status for both diabetic and nondiabetic patients at the late follow-up visit. For patients with diabetes, shoulder function (ASES: 0-30) improved from 5 (5) to 18 (6) scores (p < 0.001) and physical health status improved from 27 (6) to 38 (8) scores (p < 0.001). For patients without diabetes, shoulder function improved from 8 (5) to 19 (8) scores (p < 0.001) and physical health status improved from 31 (8) to 40 (12) scores (p < 0.001). No significant differences between diabetic and nondiabetic patients was detected at the late follow-up.ConclusionPatients with diabetes achieve large clinical benefits from shoulder arthroplasty, with follow-up outcomes equally positive to those without diabetes. Future prospective studies with a larger sample size of patients with diabetes are needed to confirm the results of this study.Level of evidenceII     

Microenergy acoustic pulse therapy restores function and structure of pelvic floor muscles after simulated birth injury

BackgroundThe mechanisms of the microenergy acoustic pulse (MAP) therapy on restoring structure and function of pelvic floor muscles (PFM) after simulated birth injury are not well understood.MethodsA total 24 female Sprague-Dawley rats were randomly grouped into sham control (sham), vaginal balloon dilation and ovariectomy (VBDO), VBDO + β-aminopropionitrile (BAPN, an irreversible LOX inhibitor), and VBDO + BAPN and treated with MAP (n=6 in each group). The MAP therapy was administered 2 times per week for 4 weeks with 1-week washout, the functional and histological studies were conducted in all 24 rats. The viscoelastic behavior of the PFM, including iliococcygeus (IC) and pubococcygeus (PC), was examined with a biomechanical assay. The structure of the PFM was assessed by immunofluorescence and Masson’s trichrome staining.ResultsThe leak point pressure (LPP) assay demonstrated that the MAP therapy group had higher LPPs compared to that of VBDO and BAPN groups. In the sham group, the muscular stiffness (K) of IC muscle was significantly higher than that of PC muscle while the pelvic floor muscle rebound activity (MRA) of PC muscle was stronger than that of IC muscle (291.26±45.33 and 241.18±14.23 N/cm², respectively). Both VBDO and BAPN decreased the MRA and increased the K in both IC and PC. Histologic examination revealed increased fibrous tissue (collagen) and degeneration of muscle fibers in both VBDO and BAPN groups. MAP therapy significantly reduced the collagen content and improved the architecture of muscle fibers.ConclusionsMAP appears to restore the structure and function of PFM by regenerating muscular fibers and improving biomechanical properties in an animal model of simulated birth injury.     

A randomized, double-blind, placebo-controlled trial on the effect of long-acting testosterone treatment as assessed by the Aging Male Symptoms scale

Study Type – Therapy (RCT) Level of Evidence 1b What's known on the subject? and What does the study add? Testosterone deficiency syndrome can be treated with testosterone replacement in the form of injectable, transdermal, buccal and oral preparations. Long‐acting i.m. testosterone undecanoate 1000 mg, which is given at 10?14 week intervals, has been shown to be adequate for sustaining normal testosterone levels in hypogonadal men. This study confirms that long‐acting i.m. testosterone undecanoate is effective in improving the health‐related quality of life in men with testosterone deficiency syndrome as assessed by the improvement in the Aging Male Symptoms scale. Testosterone treatment can be indicated in men who have poor health‐related quality of life resulting from testosterone deficiency syndrome.

OBJECTIVE

• ? To evaluate the effect of i.m. injection of testosterone undecanoate 1000 mg over 12 months on the Aging Male Symptom (AMS) scale scores in men with testosterone deficiency syndrome (TDS).

PATIENTS AND METHODS

• ? A total of 120 men >40 years old with TDS (total testosterone < 12 nmol/L and total AMS scores ≥ 27) were randomized into i.m. injection of either placebo or testosterone undecanoate 1000 mg.
• ? In all, 56 and 58 participants from the active treatment and placebo groups, respectively completed the study.
• ? An i.m. injection of either placebo or testosterone undecanoate 1000 mg was given at weeks 0, 6, 18, 30 and 48.
• ? Self‐administered AMS questionnaires were completed at weeks 0, week 18 and week 48.

RESULTS

• ? Improvement in the total AMS score was significantly greater in the treatment group than in the placebo group (F: 4.576, P= 0.017) over the 48‐week period.
• ? The mean (sd ) total AMS score was 38.46 (11.85) at baseline and 33.59 (1.69) at 48 weeks for the placebo group, and 41.73 (12.73) at baseline and 32.61 (9.67) at 48 weeks for the treatment group.
• ? The mean change in the total AMS score was ?12.6% in the placebo group and ?21.9% in the treatment group.
• ? The mean psychological and somatovegetative domain scores decreased significantly more in the treatment group than in the placebo group (?2.8 vs ?1.2, P= 0.03; and ?3.2 vs ?1.8, P= 0.016).
• ? The difference in change between the randomized groups for the sexual domain scores followed the same trend, though the difference was not significant.

CONCLUSION

• ? Long‐acting testosterone is effective in improving health‐related quality of life as assessed by the AMS scale in men with TDS.

     

Supplementation with high-dose trans-resveratrol improves ultrafiltration in peritoneal dialysis patients: a prospective,randomized, double-blind study

Background Ultrafiltration (UF) failure mostly contributes to technical failure in peritoneal dialysis (PD) patients, and one of its responsible factors is peritoneal angiogenesis. Resveratrol has been proposed to have an angiogenesis-ameliorating effect on tumor patients. We hypothesize trans-resveratrol has beneficial effects on angiogenesis-related markers in PD patients. Methods In this prospective, randomized, and double-blind trial, 72 patients were randomly assigned to 12-week treatment of low-dose or high-dose (150 or 450?mg/d) trans-resveratrol or a placebo. Visits were scheduled at 0, 4, 8, and 12 weeks after treatment. Clinical indices including 24-hour UF volume, UF rate, 24-hour urine volume, residual renal function, and dialysis adequacy (kt/v) were measured. Angiogenesis markers including vascular endothelial growth factor (VEGF), fetal liver kinase-1 (Flk-1), angiopoietin-2 (Ang-2), tyrosine kinase 2 (Tie-2), and thrombospondin-1 (Tsp-1) in peritoneal effluent were also assessed by enzyme-linked immunosorbent assay. Results Finally, 64 out of 72 patients were analyzed, 18 in the high-dose group, 22 in the low-dose group, and 24 in the placebo group. Over the 12-week period, patients in the high-dose group [mean change from baseline (95% CI): 171.4 (141.3-201.5) (mL), p?=?0.003 (Net UF); 11.3(10.5-12.1) (mL/h), p?=?0.02 (UF rate)] or the low-dose group [mean change from baseline (95% CI: 98.1 (49.5-146.7) (mL), p?=?0.007 (Net UF); 6.5 (4.4-8.6) (mL/h), p?=?0.04 (UF rate)] versus the placebo group had a significantly greater improvement in mean net UF volume and UF rate. The appearance rates of VEGF, Flk-1, and Ang-2 were more significantly reduced (appearance rates of Tie-2 and Tsp-1 increased) in the high-dose group versus the placebo group, but not in the low-dose group. Conclusion Supplementation with trans-resveratrol is beneficial to improve ultrafiltration in PD patients, and high-dose supplementation may improve ultrafiltration by ameliorating angiogenesis induced by conventional lactate-buffered PD solutions.     

Dong Quai (angelica sinensis) in the treatment of hot flashes for men on androgen deprivation therapy: results of a randomized double-blind placebo controlled trial

Objective:

To determine whether Dong Quai, a Chinese herbal compound purported to be efficacious in treating menopausal vasomotor symptoms, has a therapeutic benefit in treating hot flashes among prostate cancer patients receiving androgen deprivation therapy.

Methods:

A randomized double-blind placebo controlled trial was conducted involving 22 men receiving luteinizing hormone-releasing hormone agonist therapy for prostate cancer with bothersome hot flashes. After recording a baseline log of the frequency, duration and severity of daily hot flashes, patients were randomly assigned in a 1:1 ratio to receive daily placebo or Dong Quai for 3 months. Vasomotor and adverse events were recorded daily. Blood work including serum prostate-specific antigen (PSA), international normalized ratio of prothrombin time and partial thromoboplastin time were recorded at baseline and at the termination of the study.

Results:

Seventeen of the 22 patients enrolled completed the trial. Baseline vasomotor duration and severity were equivalent between the groups, however the number of hot flashes were significantly more in the Dong Quai group (p = 0.02). With respect to the change in number of hot flashes per day, there was a slight decrease in the mean number among the Dong Quai group which was insignificant. The absolute change and average percentage change in perceived hot flash severity was similar in both groups. There was no significant decrease in the duration of the hot flashes between the 2 groups. Disease progression based on either PSA increase or change in digital rectal exam was not observed in any patient.

Conclusion:

In this small pilot study, there were no significant differences in the severity, frequency or duration of hot flashes among men receiving placebo or Dong Quai.