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Objectives: The management of chronic pelvic pain syndrome (CPPS) is controversial because of the unclear pathogenesis of this disease. In one theory, prostatitis has been proposed to be associated with pelvic venous diseases such as varicocele and hemorrhoids, dilatation of the Santorini plexus. In this study, we investigated the effect of micronized flavonoid fraction (an agent used in venous insufficiency) in the treatment of type III CPPS.Methods: Patients diagnosed with type III chronic prostatitis were randomized and divided into 3 groups. Group 1 consisted of patients using antibiotics + anti-inflammatory + alpha-blocker (n = 47), Group 2 consisted of patients using antibiotics + anti-inflammatory + purified micronized flavonoid fraction (n = 45), and Group 3 consisted of patients using only purified micronized flavonoid fraction (n = 35).Results: The mean age of the patients was 32.93 ± 4.70 (range; 23-44) years. There was a statistically significant difference between the groups in terms of the 6th month NIH-CPSI (National Institute of Health Chronic Prostatitis Symptom Index) total scores (p = .000). Also, it was found that NIH-CPSI total scores at month 12 in Group 3 were significantly higher than those in Group 1 and 2 (p1 = .000, p2 = .002). NIH-CPSI total scores at month 12 in Group 2 were significantly higher than those in Group 1 (p = .000).Conclusion: The use of purified micronized flavonoid will decrease prostatic inflammation occurring due to increased perineal venous return.it can also be preferred as part of multimodal therapy because of its profile with relatively less side effects and being more affordable compared with alpha-blockers. [ABSTRACT FROM AUTHOR]

Objectives: The negative impact of lower urinary tract symptoms (LUTS) on affected males is substantial. This study aims to assess whether a combined auriculotherapy (AT) using laser AT (LAT) and magneto-AT (MAT) is more effective than using MAT alone or placebo for managing LUTS of aging males.Methods: A randomized controlled, double-blinded trial was conducted. Sixty-two aging males with moderate or severe LUTS symptoms were randomly allocated into groups: Group 1, placebo LAT plus placebo MAT (n = 20); Group 2, combined AT approach using LAT plus MAT (n = 20); and Group 3, placebo LAT followed by MAT (n = 22). Six ear acupoints assumed to be suitable for alleviating LUTS were used. The total treatment period was 4 weeks, with follow-up visits till 3 months. Generalized estimating equations model was used for the examination of the interactions among the groups over time.Results: A combined AT approach exhibited a stronger treatment effect in relieving voiding problems, improving the peak urinary flow rate, and reducing the post-void residual urine than the placebo group or MAT alone.Conclusions: This study demonstrates that the AT protocol used in this study for aging males with LUTS is feasible and can be adopted in future study of increased scale. [ABSTRACT FROM AUTHOR]

Rationale: Atrial fibrillation is associated with increased mortality as well as morbidity. There is strong evidence for an association between atrial fibrillation and sleep apnea. It is not known whether treatment of sleep apnea with continuous positive airway pressure (CPAP) will reduce the burden of atrial fibrillation.Objective: The Treatment of Sleep Apnea in Patients with Paroxysmal Atrial Fibrillation study will investigate the effects of CPAP in patients with paroxysmal atrial fibrillation and sleep apnea.Design: The trial has a dual center, randomized, controlled, open-label, parallel design.Methods: Two centers will enroll a total of 100 patients with both paroxysmal atrial fibrillation and sleep apnea (apnea-hypopnea index [AHI] ≥ 15 events/h) who are scheduled for catheter ablation. Patients will be randomized in a 1:1 ratio to CPAP or control group (50 patients in each arm). The effects of CPAP treatment on atrial fibrillation will be determined using an implanted loop recorder (Reveal LINQ™, Medtronic) that detects all arrhythmia episodes. The primary endpoint is a reduction of the total burden of atrial fibrillation in the intervention group, after 5 months' follow-up (preablation). Reduction in the arrhythmia recurrence rate after ablation is the main secondary endpoint. All patients will be followed up for 12 months after ablation.Conclusion: This study is the first randomized controlled trial that will provide data on the effects of CPAP therapy in patients with paroxysmal atrial fibrillation and sleep apnea. The results are expected to improve our understanding of the interaction between paroxysmal atrial fibrillation and sleep apnea. ClinicalTrials.gov Identifier. NCT02727192. [ABSTRACT FROM AUTHOR]

Objectives: The aim of this 2-group, parallel, double blind single-centre RCT was to evaluate the acute and chronic impacts of high flavanol high theobromine (HFHT) chocolate consumption on endothelial function, arterial stiffness and blood pressure (BP) in women at risk of preeclampsia.Methods: 131 pregnant women considered at risk of preeclampsia based on uterine artery Doppler ultrasound were divided into two groups (HFHT or low flavanol and theobromine chocolate (LFLT). Acute changes in plasma flavanol and theobromine, peripheral arterial tonometry and BP were evaluated at randomization (0, 60 and 120 min after a single 40-g dose of chocolate) and again 6 and 12 weeks after daily 30-g chocolate intake. The EndoPAT 2000 provided reactive hyperemia index (RHI) and adjusted augmentation index (AIx) as markers for endothelial function and arterial stiffness, respectively.Results: Compared with LFLT, acute HFHT intake significantly increased plasma epicatechin and theobromine (p < 0.0001), decreased AIx (p < 0.0001) and increased diastolic BP (3.49 ± 3.40 mmHg increase in HFHT group vs 1.55 ± 2.59 mmHg increase in LFLT group, p = 0.0008). Chronic HFHT compared with LFLT intake significantly increased plasma theobromine (p < 0.0001). No other significant within group or between group changes were observed.Conclusions: Acute consumption of HFHT, compared to LFLT, increased plasma epicatechin and theobromine concentrations and decreased arterial stiffness, with no effect on endothelial function and a marginal increase in diastolic BP. Chronic HFHT intake increased plasma theobromine, though it did not have positive impacts on endothelial function, arterial stiffness or BP when compared to LFLT in pregnant women at risk of PE. [ABSTRACT FROM AUTHOR]

Background and Objectives: Internet-based interventions are a viable treatment option for various mental problems. However, their effects on the burnout syndrome yielded mixed results. In this paper, we examine the efficacy of a structured and therapist-guided internet intervention, based on solution-focused and cognitive-behavioral therapy, for individuals with symptoms of burnout.Design: Two-arm, Internet-based, randomized, wait-list controlled trial (RCT).Methods: Participants were recruited through in-house events and online advertising. They were randomly assigned to the intervention or a wait-list. Group comparison was conducted three months after randomization. Outcomes were the burnout level according to the Maslach Burnout Inventory (MBI-GS) and the levels of depression, anxiety and stress according to the DASS-21.Results: Thirty-nine participants were included in the trial; 36 (92.3%) took part at the 3-months-follow-up. Intention-to-treat analyses revealed significant group differences in favor of the intervention group in depression (d = 0.66), cynicism (d = 0.87) and personal accomplishment (d = 0.75).Conclusions: The intervention helped ameliorate symptoms of work-related stress and burnout. Although limited by a small sample size, the study suggests that the program provides effective support for affected individuals. However, further studies with bigger sample sizes should be conducted to examine the effects of such programs more precisely. [ABSTRACT FROM AUTHOR]

Objective: To determine whether oral labetalol is associated with a shorter time to blood pressure control compared to oral extended release nifedipine for management of persistent postpartum hypertension.Study Design: This randomized controlled trial conducted between June 2014 and June 2015 included women who delivered at ≥32 weeks' gestation with persistent postpartum hypertension (sustained blood pressure ≥150/100 mmHg) requiring an oral antihypertensive agent. We included women with gestational hypertension, preeclampsia, or chronic hypertension not previously on medication. Women were randomized to labetalol or nifedipine, and the allocated study drug was incrementally increased to achieve blood pressure control. The primary outcome was time to sustained blood pressure control defined as the absence of severe hypertension for at least 12 hours. Secondary outcomes included postpartum length of stay, need for increased dosing, need for additional oral antihypertensive agents, and patient reported side effects. Twenty women were needed in each group as determined by the sample size calculation.Results: We randomized 25 women to oral labetalol and 25 women to oral extended release nifedipine. The time to achieve BP control was similar between labetalol and nifedipine groups (37.6 hours versus 38.2 hours, p = 0.51). Secondary outcomes including postpartum length of stay, need for increased dosing, and need for additional oral antihypertensive agents were similar between groups. For women discharged on a single agent, significantly more subjects in the labetalol group (16/21) compared to the nifedipine group (10/22) achieved BP control with the initial starting dose (76% versus 46%, p = 0.04). No major side effects were observed. Minor side effects were significantly more common in women taking nifedipine compared to labetalol (48% versus 20%, p = 0.04).Conclusions: Both labetalol and nifedipine were effective for control of persistent postpartum hypertension. However, labetalol achieved control significantly more often with the starting dose and had fewer side effects.Clinical Trial Registration: Oral nifedipine versus oral labetalol, NCT02168309. https://clinicaltrials.gov/ct2/show/NCT02168309?term=labetalol+versus+nifedipine&rank=2. [ABSTRACT FROM AUTHOR]

Objective: Threatened preterm labor (tPTL) is a complication of pregnancy. Identification of women and clinical definition differs between countries. This study investigated differences in tPTL and effectiveness of vaginal progesterone to prevent preterm birth (PTB) between two countries.Methods: Secondary analysis of a randomized controlled trial (RCT) from Argentina and Switzerland comparing vaginal progesterone to placebo in women with tPTL (n = 379). Cox proportional hazards analysis was performed to compare placebo groups of both countries and to compare progesterone to placebo within each country. We adjusted for baseline differences. Iatrogenic onset of labor or pregnancy beyond gestational age of interest was censored.Results: Swiss and Argentinian women were different on baseline. Risks for delivery <14 days and PTB < 34 and < 37 weeks were increased in Argentina compared to Switzerland, HR 3.3 (95% CI 0.62-18), 54 (95% CI 5.1-569) and 3.1 (95% CI 1.1-8.4). In Switzerland, progesterone increased the risk for delivery <14 days [HR 4.4 (95% CI 1.3-15.7)] and PTB <37 weeks [HR 2.5 (95% CI 1.4-4.8)], in Argentina there was no such effect.Conclusion: In women with tPTL, the effect of progesterone may vary due to population differences. Differences in populations should be considered in multicenter RCTs. [ABSTRACT FROM AUTHOR]

Background and Objectives: The present study evaluated the effectiveness of a single clinician delivered brief intervention (BI) to reduce problem alcohol use and illicit substance use in an opiate-dependent methadone maintained cohort of patients attending for treatment. Methods: Four addiction treatment centers were randomly assigned to either treatment as usual (TAU; control group) or BI (intervention group). Clinicians screened patients using the alcohol, smoking, and substance involvement screening test (ASSIST) screening tool at baseline and again at three-month follow up. Fidelity checks were performed to ensure that training was delivered effectively and uniformly across all study sites. Feasibility of administering a BI within daily practice was assessed through intervention fidelity checks, patient satisfaction questionnaires and process evaluation. Results: A total of 465 patients were screened (66% of the overall eligible population) with a total of 433 (93%) ASSIST positive cases. Randomization was effective, with no differences in the control versus the intervention arms at baseline for key demographic or clinical indicators including substance us. There was a statistically significant difference between global risk score for the intervention (x = 39.36, sd = 25.91) group and the control group (x = 45.27, SD = 27.52) at 3-month follow-up (t(341) = −2.07, p <.05). Conclusions: This trial provides the first evidence that a single clinician delivered BI can result in a reduction in substance use within a methadone maintained opiate-dependent cohort, and this effect is sustained at three month follow up. [ABSTRACT FROM AUTHOR]

Objective: This study aimed to estimate the effectiveness of L-arginine for preventing preeclampsia in high-risk pregnancy.Methods: We performed a randomized, double-blind, placebo-controlled, clinical trial in patients with high-risk factors for preeclampsia. Fifty subjects received L-arginine, beginning from the 20th week of gestation. An additional 50 patients received homologated placebo.Results: The placebo group had a higher number of cases of preeclampsia (11/47) compared with the L-arginine group (3/49, P = 0.01). Birth weight was higher in the L-arginine group and there was a smaller number of preterm births (P = 0.03).Conclusion: L-arginine is effective for preventing preeclampsia. [ABSTRACT FROM AUTHOR]

In order to increase patient active engagement during patient–provider interactions, we developed and implemented patient training sessions in four antiretroviral therapy (ART) clinics in Namibia using a “Patient Empowerment” training curriculum. We examined the impact of these trainings on patient–provider interactions after the intervention. We tested the effectiveness of the intervention using a randomized parallel group design, with half of the 589 enrolled patients randomly assigned to receive the training immediately and the remaining randomized to receive the training 6 months later. The effects of the training on patient engagement during medical consultations were measured at each clinic visit for at least 8 months of follow-up. Each consultation was audiotaped and then coded using the Roter Interaction Analysis System (RIAS). RIAS outcomes were compared between study groups at 6 months. Using intention-to-treat analysis, consultations in the intervention group had significantly higher RIAS scores in doctor facilitation and patient activation (adjusted difference in score 1.19,p = .004), doctor information gathering (adjusted difference in score 2.96,p = .000), patient question asking (adjusted difference in score .48,p = .012), and patient positive affect (adjusted difference in score 2.08,p = .002). Other measures were higher in the intervention group but did not reach statistical significance. We have evidence that increased engagement of patients in clinical consultation can be achieved via a targeted training program, although outcome data were not available on all patients. The patient training program was successfully integrated into ART clinics so that the trainings complemented other services being provided. [ABSTRACT FROM PUBLISHER]

Background: Levels of stress and burnout increase during nursing education. This development has consequences for nursing students' health, learning, competence, and interest in quality issues in health care.Design: In a randomized controlled pilot trial with a sample of 113 nursing students the effect of an intervention using techniques from acceptance and commitment training (ACT) to prevent the development of stress and burnout was evaluated.Method: The 6 × 2-hour program was compared to standard treatment (reflection seminars) post-intervention and at a three-month follow-up using longitudinal analysis of mean response profiles. Mechanisms of change were investigated using a baseline-post intervention two-mediator model.Results: The intervention resulted in increased mindful awareness and decreased experiential avoidance, as well as decreased perceived stress and burnout. Levels of mindful awareness and perceived stress were sustained at follow-up. The proposed mechanisms of change were partly supported by the data.Conclusion: This study shows that techniques from ACT might have the potential to contribute to preventing the development of stress and burnout during nursing education. However, additional studies are needed to validate these results. [ABSTRACT FROM AUTHOR]

Objective: To evaluate the efficacy of a novel formulation of extended-release/immediate-release (ER) naproxen sodium over 24 h in a dental pain model.Research Design and Methods: Two randomized, double-blind, placebo-controlled trials in moderate to severe pain after extraction of one or two impacted third molars (at least one partial mandibular bony impaction). Treatment comprised oral ER naproxen sodium 660 mg (single dose), placebo (both studies) or immediate-release (IR) naproxen sodium 220 mg tid (study 2).Main Outcome Measures: Primary efficacy endpoint: 24-h summed pain intensity difference (SPID). Secondary variables included total pain relief (TOTPAR), use of rescue medication. All treatment-emergent adverse events were recorded.Clinical Trial Registration: NCT00720057 (study 1), NCT01389284 (study 2).Results: Primary efficacy analyses: pain intensity was significantly lower over 24 h with ER naproxen sodium vs. placebo (p < 0.001), with significant relief from 15 min (study 2). In study 2, ER naproxen sodium was non-inferior to IR naproxen sodium, reducing pain intensity to a comparable extent over 24 h. TOTPAR was significantly greater with ER and IR naproxen sodium vs. placebo at all time points, with generally comparable differences between active treatments. Significantly more placebo patients required rescue medication vs. ER and IR naproxen sodium from 2-24 h post-dose. Once daily ER naproxen sodium was generally safe and well tolerated, with a similar safety profile to IR naproxen sodium tid.Limitations: The studies were single dose, with limited ability to assess efficacy or safety of multiple doses over time. As the imputed pain score meant that estimated treatment differences may have been biased in favor of ER naproxen sodium, a post hoc analysis evaluated the robustness of the results for pain relief.Conclusions: A single dose of ER naproxen sodium 660 mg significantly reduced moderate to severe dental pain vs. placebo and was comparable to IR naproxen sodium 220 mg tid. Significant pain relief was experienced from 15 min and sustained over 24 h, resulting in a reduced need for rescue medication. ER naproxen sodium 660 mg once daily is a convenient and effective therapy providing 24 h relief of pain. [ABSTRACT FROM AUTHOR]

Background: Because of their ability to reach a much wider audience than face-to-face counseling or psychoeducation, computer-delivered interventions for risky or potentially problematic use have been increasing on college campuses. However, there are very few studies that examine who benefits most from such interventions.Objectives: The purpose of this study was to determine if participation in Alcohol-Wise, a computerized intervention, is associated with changes in alcohol drinking behavior and its consequences, perceptions of college drinking norms, and expectancies. It was hypothesized that class level (i.e. freshman/sophomore versus junior/senior) would moderate the effectiveness of Alcohol-Wise.Method: College students (n = 58) were randomly assigned to one of two conditions: (i) the computer-delivered intervention or (ii) wait-list control. Measures were completed at baseline and approximately 30-days later.Results: At follow-up, freshman and sophomore students in the intervention group showed significant reduction in peak number of standard drinks and blood alcohol concentration, but the effect was not observed for juniors and seniors. The intervention group reported more accurate estimates of drinking norms at follow-up relative to controls. There were no significant changes over time in alcohol expectancies in either group.Conclusion: This study provides support for the potential usefulness of Alcohol-Wise intervention at reducing short-term drinking among underclassmen but not upperclassmen in a 4-year college setting. These findings suggest that computerized interventions may be more effective when provided early, but not later, in a student's college career. [ABSTRACT FROM AUTHOR]

Objective: Clopidogrel napadisilate has better chemical stability than clopidogrel bisulfate. Our trial's objective was to compare the efficacy and safety of clopidogrel napadisilate with clopidogrel bisulfate in participants with ischemic stroke.Research Design and Methods: The study was a phase 4, 4 week, randomized, parallel-group, non-inferiority trial. Patients with ischemic stroke were randomized to receive either clopidogrel napadisilate 75 mg or clopidogrel bisulfate 75 mg. The primary study endpoint was change from baseline in P2Y12 percentage inhibition at week 4. The primary analysis was conducted in the per-protocol population. Non-inferiority was confirmed if the lower limit of the 95% confidence interval (CI) of the treatment difference was greater than or equal to -9.0% points.Results: Sixty-one participants were randomly assigned clopidogrel napadisilate and 60 were randomly assigned clopidogrel bisulfate. Thirty-nine participants in the clopidogrel napadisilate group and 39 in the clopidogrel bisulfate group were analyzed for the primary endpoint. At 4 weeks, mean P2Y12 percentage inhibition had increased in both treatment groups. The estimated mean change from baseline was 22.3% with clopidogrel napadisilate and 21.4% with clopidogrel bisulfate; the estimated treatment difference of 0.9% (95% CI, -8.6 to 10.4) confirmed the non-inferiority of clopidogrel napadisilate to clopidogrel bisulfate.Conclusions: Clopidogrel napadisilate was non-inferior to clopidogrel bisulfate as assessed by change in P2Y12 percentage inhibition. Rates of adverse events were similar between the two groups. Therefore, clopidogrel napadisilate is a useful alternative option for the dosing of ischemic stroke patient populations. [ABSTRACT FROM AUTHOR]