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Purpose: Postmicturition dribbling (PMD) is a stressful symptom in middle-aged men characterized by urinary leakage after the completion of normal voiding. Appropriate treatments have not yet been introduced. This study assessed the efficacy of treatment of PMD with 75 mg udenafil daily.Materials and Methods: The study included 138 men with regular sexual lifestyles. The Hallym PMD questionnaire (HPMDQ) was used to assess PMD symptoms. After all basic examinations, patients were randomly assigned to either udenafil or placebo. Patients completed the surveys, uroflowmetry (UFM), a bladder scan, and the paper test during the follow-up visit.Results: The mean age of the patients was 57.6 years. PMD with one of every three urinations was experienced by 59 patients (42.8%), whereas 45 patients (32.6%) experienced PMD with two of every three urinations. PMD with every urination was experienced by 34 patients (24.6%). More than half of the patients (89 patients, 65.4%) indicated that persistent PMD symptoms would likely result in moderate to severe discomfort in their daily activities. As time passed, the udenafil group showed significant improvement in PMD symptoms (p = 0.001).Conclusion: Udenafil 75 mg once daily can be an effective treatment for patients with PMD symptoms. [ABSTRACT FROM AUTHOR]

The genitourinary syndrome of menopause (GSM) and stress urinary incontinence (SUI) are common clinical challenges for women’s health and quality of life. The laser treatment and particularly the vaginal erbium laser (VEL) may provide a new non-invasive treatment for both GSM and SUI. However, the estimation of the ultimate results of different laser treatments may be altered by different issues, such as patient selection, concomitant treatments, and long-term effect of vaginal laser thermotherapy. In the present paper, we present the protocol for a large multicenter study on the evaluation of the efficacy and safety of VEL for the treatment of GSM and SUI, the Vaginal Erbium Laser Academy Study (VELAS). This study will evaluate the effects of three laser applications in 1500 postmenopausal women. Subjective and objective symptoms will be evaluated prior to the first laser treatment with follow-up visits after 4 weeks from the last laser application, and subsequently after every 3 months for 1 year. Findings from the VELAS have the potential to affect clinical care practice and health decisions for millions of women world-wide for a non-hormonal treatment for GSM and a non-invasive treatment of SUI. [ABSTRACT FROM PUBLISHER]

Objective: To investigate the effect of high-intensity exercise on emotional distress, fatigue, and ability to do a full day’s activities in patients with axial spondyloarthritis (axSpA). Method: A total of 28 physically inactive axSpA patients were randomized to either an exercise group (EG), which performed 12 weeks of cardiorespiratory and strength exercises, or a control group (CG), which received treatment as usual. The outcomes reported in this paper are secondary outcomes in the trial and included emotional distress (General Health Questionnaire-12, 0–36, 36 = worst), fatigue [numeric rating scale (NRS), 0–10, 10 = worst], and ability to do a full day’s activities (NRS, 0–10, 10 = worst). Post-intervention differences were assessed by analysis of covariance with baseline values as covariates. Results: Twenty-four patients were included in the analyses. All patients in the EG followed the exercise protocol. The EG had a statistically significant beneficial effect [mean group differences (95% confidence interval)] on emotional distress [−5.8, (−9.7, −1.9), p < 0.01], fatigue [−2.4, (−4.3, −0.4), p = 0.02], and ability to do a full day’s work [−2.2, (−3.9, −0.4), p = 0.02] compared to the CG. Conclusion: This pilot study showed promising effects of cardiorespiratory and strength exercises on emotional distress, fatigue, and ability to do a full day’s activities in patients with axSpA. The findings need to be confirmed in a larger trial. [ABSTRACT FROM PUBLISHER]

Clinical relevance: Home-based videogame treatments are increasingly popular for amblyopia treatment. However, at-home treatments tend to be done in short sessions and with frequent disruptions, which may reduce the effectiveness of binocular visual stimulation. These treatment adherence patterns need to be accounted for when considering dose-response relationships and treatment effectiveness.Background: Home-based videogame treatments are increasingly being used for various sensory conditions, including amblyopia ('lazy eye'), but treatment adherence continues to limit success. To examine detailed behavioural patterns associated with home-based videogame treatment, we analysed in detail the videogame adherence data from the Binocular tReatment of Amblyopia with VideOgames (BRAVO) clinical trial (ACTRN12613001004752).Methods: Children (7-12 years), teenagers (13-17 years) and adults (≥ 18 years) with unilateral amblyopia were loaned iPod Touch devices with either an active treatment or placebo videogame and instructed to play for a total of 1-2 hours/day for six weeks at home. Objectively-recorded adherence data from device software were used to analyse adherence patterns such as session length, daily distribution of gameplay, use of the pause function, and differences between age groups. Objectively-recorded adherence was also compared to subjectively-reported adherence from paper-based diaries.Results: One hundred and five of the 115 randomised participants completed six weeks of videogame training. Average adherence was 65% (SD 37%) of the minimum hours prescribed. Game training was generally performed in short sessions (mean 21.5, SD 11.2 minutes), mostly in the evening, with frequent pauses (median every 4.1 minutes, IQR 6.1). Children played in significantly shorter sessions and paused more frequently than older age groups (p < 0.0001). Participants tended to over-report adherence in subjective diaries compared to objectively-recorded gameplay time.Conclusion: Adherence to home-based videogame treatment was characterised by short sessions interspersed with frequent pauses, suggesting regular disengagement. This complicates dose-response calculations and may interfere with the effectiveness of treatments like binocular treatments for amblyopia, which require sustained visual stimulation. [ABSTRACT FROM AUTHOR]

Objective: To evaluate the effectiveness of viscosupplementation with single-injection hylan G-F20 (Synvisc-One) in knee osteoarthritis (OA), during routine clinical care, in a 52 week observational study.Research Design and Methods: The LOBRAS study involved a 1 year long, multi-center, quasi-experimental, repeated measures, observational study. Consenting patients in Australia fulfilling inclusion/exclusion criteria under the care of a medical specialist in routine clinical practice were enrolled. Prior to, and for 52 weeks following, intra-articular single-injection hylan G-F20, patients were repeatedly evaluated using the WOMAC NRS4.1 Index and the SF-36 questionnaire. The WOMAC NRS4.1 was administered by mobile phone (with paper back-up), and the SF-36 was administered on paper. Patients were monitored for adverse events.Main Outcome Measures: Western Ontario and McMaster (WOMAC) OA Index, and the Short Form 36 questionnaire (SF-36 v2).Results: A total of 131 patients with knee OA were enrolled, of whom 119 provided both pre- and post-intervention WOMAC data. Statistically significant improvements (with a maximum of p ≤ .025) from baseline to Week 12, Month 6 and Week 52 were detected, by intention-to-treat (ITT) and per-protocol (PP) analyses, in WOMAC Pain, Stiffness, Function, PGA, and Total Score, SF-36 PCS, and WOMAC-derived HUI3. Adverse event (AE) monitoring detected treatment-related AEs in 5.3% of patients.Conclusions: The effectiveness of single-injection hylan G-F20 in routine clinical care is supported by the detection of statistically significant, clinically important improvements in WOMAC Pain, Stiffness, Function, Total, and PGA outcomes, and statistically significant improvements in SF-36 PCS and WOMAC-derived HUI3 outcomes at multiple time points. Limitations of this study include lack of a control group or blinding. No predictive indicators of the response to treatment were identified. In general single-injection hylan G-F20 was well tolerated with very few patients experiencing any treatment-related adverse events. Collectively, these observations attest to the effectiveness of single-injection hylan G-F20 and complement previous observations in routine clinical care. [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]

This paper presents evidence regarding the possibility of a cumulative effect of drug-abuse treatment on reducing risky sexual behavior among individuals entering drug-abuse treatment in the United States from 1991-1993 and participating in the Drug Abuse Treatment Outcome Study (DATOS). Analyses were done of the relationship between lifetime treatment exposure and risky sex by drug users during the year before intake into DATOS. Analyses controlled for age, drug-use severity, criminal history, antisocial conduct disorder, and other factors that might have confounded the relationship between treatment exposure and risky sex. Results indicated that users with more lifetime treatment exposure had lower scores for risky sex. This finding is consistent with the hypothesis that successive episodes of treatment may have long-term cumulative effects on drug users' HIV-risk behavior. [ABSTRACT FROM AUTHOR]

Objective: To evaluate long-term use of Hysingla®ER (HYD), a single-entity, extended-release, once-daily hydrocodone bitartrate tablet with abuse-deterrent properties in patients with moderate-to-severe chronic noncancer and nonneuropathic pain. Methods: This open-label study consisted of a dose-titration period (up to 45 days), a 52-week maintenance period and a 24-week extension period. Opioid-naïve or opioid-experienced patients with controlled or uncontrolled chronic pain conditions were treated with HYD 20–120 mg daily. Supplemental nonopioid and short-acting opioid analgesics were permitted. This paper presents the results of 106 patients who continued HYD treatment for up to 76 weeks. Primary safety measures included the incidence of adverse events, as well as audiologic, clinical laboratory and electrocardiogram measurements. Effectiveness was measured by the change between baseline and the overall 76-week treatment period in “average pain over the last 24 h” (0 = no pain, 10 = pain as bad as you can imagine), Brief Pain Inventory-Short Form survey, Medical Outcomes Study 36-Item Short Form Health Survey, Medical Outcomes Study Sleep Scale-Revised and concomitant nonstudy opioid analgesic use. Results: Among 410 patients who completed the maintenance period, 106 continued into the extension. Of these, 83 (78%) completed the entire 76-week treatment period. Treatment-emergent adverse events were typical of those observed with μ-opioid agonists. No study drug abuse or diversion was reported. Clinically important analgesia and functional improvement were achieved during the dose-titration period and were maintained in most patients throughout 76 weeks without the need for continued HYD dose increases or changes in concomitant nonstudy opioid analgesics. The mean pain score was 6.1 at baseline, 3.8 at the end of the dose titration period and 3.8 through 76 weeks. Conclusions: HYD was generally well tolerated. No unexpected safety concerns emerged. Pain control was sustained throughout 76 weeks of treatment. [ABSTRACT FROM PUBLISHER]

The notion that sex offender treatment does not work fuels public outrage and demands for protective legislation. This paper will respond to a recent meta-analysis reporting major weaknesses in research designs that preclude drawing conclusions about the effectiveness of sex offender treatment. Methodological and ethical challenges exist in the investigation of counselling interventions in general and sex offender treatment specifically, and we argue that the medicalization of psychotherapy research may have inherent flaws. Alternatives to dichotomous recidivism outcomes are proposed, including harm reduction measures and reduction of maladaptive behaviours. Future clinical directions for sex offender treatment are explored, including application of risk-needs-responsivity models, a focus on process as well as content and incorporation of principles of trauma-informed care. [ABSTRACT FROM PUBLISHER]

Compares the results of primary angioplasty with thrombolytic therapy for acute myocardial infarction. Decrease in mortality with primary angioplasty; Reduction of reocclusion with the use of thrombolytic therapy; Time as determinant of the outcome in patients.

Background: Problematic cocaine use remains a significant public health issue, particularly among women. However, no concerted efforts have been made to target a pharmacological treatment option for women with cocaine use disorder (CUD) despite preclinical, human laboratory, and a limited number of clinical studies demonstrating that progesterone can attenuate the effects of cocaine to a greater extent in women than men.Objectives: To evaluate the safety, tolerability, and preliminary efficacy of progesterone for treating women with CUD.Methods: A 10-week double-blind randomized treatment trial was conducted. Prior to randomization, participants were required to achieve cocaine abstinence (1 week) before assignment to progesterone (up to 400 mg/day) or placebo. The primary efficacy outcomes were days to relapse and cocaine abstinence during the last 3 weeks of the trial. The frequency of side effects was also assessed.Results: 227 women were assessed for eligibility. Twenty-five women entered treatment and 21 were randomized to progesterone (n = 11) or placebo (n = 10). The majority of women relapsed in less than 4 days with no differences between the two groups. Further, there were no significant differences between the progesterone and placebo groups in terms of cocaine abstinence during the last 3 weeks of the trial (27% and 10% respectively). The most commonly reported side effects were headache and fatigue, but no group differences were noted.Conclusions: Progesterone was well tolerated and safe and supports further study is in a larger sample to determine if exogenous progesterone is an effective treatment option for women with CUD.(ClinicalTrials.gov Identifier: NCT00632099). [ABSTRACT FROM AUTHOR]

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Introduction: Traditional and current perception for benefit of percutaneous coronary intervention (PCI) is that patients with stable angina will obtain symptom relief as well as improved exercise capacity after percutaneous revascularization. This common clinical perception is put to test in the ORBITA trial, the first blinded, randomized placebo-controlled clinical study ever conducted.Areas covered: Coronary artery disease, percutaneous coronary intervention, medical therapy.Expert Commentary: The authors found no significant improvement in exercise time, functional status, angina relief and quality of life in the PCI group compared with placebo. A possible explanation for this neutral outcome is that PCI is overvalued in symptom relief and to some extent explained by placebo effects or transient non-cardiac causes of chest pain. However, the chosen exercise tolerance improvement may have been too optimistic in a population with good functional capacity. Also PCI was anatomic and not functional driven, and follow-up duration may have been to short to wear off the placebo effect. While the evidence is not sufficient to alter revascularization guidelines, the message of this 200-patient, high-quality study is potent and will reverberate throughout the cardiology community and warrants further study. [ABSTRACT FROM AUTHOR]

Lung cancer still remains associated with a high mortality rate and more efficacious therapies are needed in order to improve the disease outcome. Nivolumab is a monoclonal antibody which blocks the programmed death-1 receptor which is currently evaluated in phase III clinical trials in advanced lung cancer. Here, we evaluate the results of a phase III study in which nivolumab efficacy and safety were compared to those of docetaxel. Nivolumab was able to improve survival and progression-free survival and exhibited a very good safety profile. Further clinical data are needed in order to better position this therapy among the existing methods. The promising results support the use of this therapy as a stand-alone approach. [ABSTRACT FROM AUTHOR]

Kidney cancer accounts for approximately 2% of new cancers and conventional treatment with nephrectomy followed by IL-2 or IFN-alpha treatment does not provide long-term survival benefit in many patients. Increased understanding of the pathophysiology of renal cell carcinoma has prompted the development of targeted therapies for patients with this disease, including sunitinib. This paper reviews the most recent efficacy and safety data for sunitinib, as well as currently ongoing and planned studies for this receptor tyrosine kinase inhibitor. Results from a large-scale, long-term, Phase III trial have established sunitinib as the standard of care for first-line treatment of patients with advanced renal cell carcinoma, and it is now the reference standard against which other therapies for this cancer should be evaluated. [ABSTRACT FROM AUTHOR]

Purpose: The aim of this study was to evaluate and compare incidence and outcomes of management of acute endophthalmitis after microincision vitrectomy surgery (MIVS) and intravitreal injections (IVIs).Methods: Medical records were retrospectively reviewed from January 2012 to December 2017, and the incidence, clinical and microbiological profiles of acute endophthalmitis were documented.Results: Of 26,332 MIVS and 24,143 IVI performed, incidence of acute endophthalmitis in MIVS group was 0.027% (1 in 3761 cases) against 0.054% (1 in 1857 cases) in IVI. Gram-positive organisms were causative in post IVI group as against gram-negative organisms in MIVS group.Conclusion: Incidence of endophthalmitis after IVI is almost twice that after MIVS. A trend toward poorer outcomes in MIVS eyes was observed. Both MIVS and IVI being pars plana procedures warrant similar kind of aseptic precautions. [ABSTRACT FROM AUTHOR]

Psychological distress is common in persons with traumatic brain injury (TBI) but treatments remain underdeveloped. This randomized controlled trial of Acceptance and Commitment Therapy (ACT) was designed to address this gap. Ninety-three persons with medically-documented complicated mild to severe TBI, normal-to-mildly impaired memory, and clinically significant psychological distress in the chronic phase of recovery were randomized to receive eight weeks of ACT (manualized with adaptations to address TBI-related cognitive impairments) or a single session of needs assessment, brief counseling/education, and referral. The ACT group showed significantly greater reduction of psychological distress (Brief Symptom Inventory 18) and demonstrated improvements in psychological flexibility and commitment to action (Acceptance and Action Questionnaire-II (AAQ-II) scores). The number of treatment responders (post-treatment BSI 18 GSI T scores <63) was larger in the ACT group than in the control group. Entry of AAQ-II scores into the model of between-group differences in BSI 18 GSI T scores indicated that core ACT processes explained the variance in treatment group outcomes. Provision of ACT reduces psychological distress in persons with TBI in the chronic phase of recovery when adaptations are made to accommodate TBI-related cognitive impairments. Additional clinical trials with a structurally equivalent control group are needed. [ABSTRACT FROM AUTHOR]

Introduction: Traumatic bone infection represents a clinical challenge for orthopedic surgeons. Traditional treatments include surgical debridement and antibiotic, but prolonged use of antibiotic may lead to colonization of resistant bacteria and other adverse reactions.Areas covered: Platelet-rich plasma (PRP), a biological product extracted from the peripheral blood of patients, has been widely used in the field of tissue repair in recent years. Because if its structural and antibacterial properties, PRP is an innovative option for the prevention and treatment of infections. This review assesses the recent scientific literature on PRP, specifically its in the treatment of infections. To this end, a literature review was conducted using the PubMed and Web of Science databases with the following keywords 'platelet-rich plasma (PRP)'; 'PRP AND traumatic bone infections'; 'PRP AND bone defect'; 'PRP AND antibiotics'; and 'PRP AND wound healing'.Expert opinion: This review focuses on the mechanism of action, preparation methods, clinical applications and other aspects related to PRP to provide a reference for its use in the treatment of traumatic bone infections, thereby enhancing the therapeutic effectiveness and improving the prognosis of patients. [ABSTRACT FROM AUTHOR]

Background: Data regarding ischemic postconditioning during percutaneous coronary intervention (PCI) as compared conventional PCI alone has yielded conflicting results.Methods: Online databases comparing use of ischemic postconditioning percutaneous coronary intervention (ICP-PPCI) in STEMI patients with conventional PPCI were selected. Mortality, heart failure (HF), myocardial infarction (MI), and major adverse cardiac events (MACE) were evaluated. The primary outcome was composite of HF, MI, and mortality. Pooled risk ratio (RR) with 95% confidence interval (CI) were computed using random-effects model.Results: Eight studies consisting of 2,566 patients (ICP-PPCI n = 1,228; PPCI n = 1,278) were included. The mean age for PPCI group was 61.38 ± 7.86 years (51% men) and for PCI 59.83 ± 8.94 years (47% men). There were no differences in outcome between ICP-PPCI and PPCI in terms of HF (RR 0.87 95% CI0.51-1.48; p = 0.29), MI (RR 1.28, 95%CI0.74-2.20; p = 0.20), mortality (RR 0.93, 95%CI0.64-1.34; p = 0.58), and MACE (RR 0.89, 95%CI0.74-1.07; p = 0.22). The results for composite event for the ICP-PPCI and PPIC procedures, at ≥1 year follow-up duration, were comparable (RR 1.00 95%CI0.82-1.22; p = 1).Conclusion: Ischemic postconditioning post percutaneous coronary intervention in STEMI patients has no long-term benefits over conventional PCI. [ABSTRACT FROM AUTHOR]

The aim of this study was to assess the effect of acupressure with or without ice on reducing pain and anxiety during labour. The anxiety level of mothers was measured before and after study using Spielberger Inventory along with the labour pain. To improve the strength of this study, a meta-analysis was conducted on the effect of acupressure in point LI-4 on anxiety during labour. Ninety women in labour were randomly divided into three groups: acupressure with ice, acupressure without ice and the control group. The result suggested that women receiving both acupressure with ice (p = .005) or without ice (p < .001) experienced less labour pain in comparison with the control group. Also, the labour pain severity in acupressure without ice was lower than the group with ice (p < .001). Acupressure with (p = 1) or without (p = .09) ice was not significantly different from the control group in terms of the anxiety level. However, women in the group of acupressure without ice experienced less anxiety in comparison with acupressure with ice (p = .04). The difference in pain severity before and after treatment with acupressure with (RCI = 2.86) or without ice (RCI = 5.54) was clinically significant. The intervention was not clinically meaningful in terms of anxiety.Impact statementWhat is already known on this subject? Previous trials have exhibited that acupressure with/without ice reduced pain and anxiety during labour.What do the results of this subject add? The results of this research was consistent with previous studies, suggesting that acupressure, with or without ice, is more effective than the control group regarding labour pain. However, the group of acupressure with ice was not different from the control group with respect to the anxiety level.What are the implications of these findings for clinical practice and/or further research? In light of advantages, such as growing preference of women, researcher and health care providers for physiological delivery coupled with its safety and simplicity, it can be used as an effective technique to manage labour pain. Further studies are required to assess the effect of acupressure at L4 on the anxiety level. [ABSTRACT FROM AUTHOR]

Introduction: In the current era of relatively scarce antibiotic production and significant levels of antimicrobial resistance, optimization of pharmacokinetics and pharmacodynamics of antibiotic therapy is mandatory. Prolonged infusion of beta-lactam antibiotics in comparison to the intermittent infusion has the theoretical advantage of better patient outcomes. Apparently, conflicting data in the literature possibly underestimate the benefits of prolonged infusion of antibiotic treatment.Areas Covered: We provide our perspective on the subject based on our experience and by critically evaluating literature data.Expert Opinion Commentary: In our opinion, the available data are suggestive of the beneficial role of prolonged infusion of beta-lactams in regard to piperacillin/tazobactam and carbapenems after administering a loading dose. While more data from randomized controlled trials are necessary to solidify or negate the evident benefits of prolonged infusion of the aforementioned antibiotics, clinicians should strongly consider this mode of administration of relevant antibiotics, especially in patients with severe infections. [ABSTRACT FROM AUTHOR]

The aim of this multicentric, prospective study was to evaluate the effects of vaginal erbium laser (VEL-SMOOTH®) on sexual function in postmenopausal women suffering from the genitourinary syndrome of menopause (GSM). This study was performed on an outpatient basis without anesthesia or drug use before or after the intervention, using an erbium laser (XS Fotona Smooth®, Fotona, Ljubljana, Slovenia) in 1081 postmenopausal women (age 54.3 ± 3.9 years) treated with up to three laser applications every 30 days. Patients were assessed using the Female Sexual Function Index (FSFI) and the Female Sexual Distress Scale-Revised (FSDS-R). No adverse events were recorded during the study. The FSDS-R scores (n = 554), from basal values of 25.5 ± 3.5, were 11.5 ± 3.0, 10.5 ± 3.5 and 11.5 ± 3.5 at the 4-, 12- and 24-week follow-ups, respectively (p < 0.01 vs. corresponding basal values). Individual FSFI domain scores (n = 569) significantly (p < 0.001) increased after VEL-SMOOTH® treatment and remained significantly higher up to the 24th week after the end of treatment. The total scores, from basal values of 15.5 ± 1.5, were 27.5 ± 2.5, 27.6 ± 2.7and 27.0 ± 3.5 at the 4-, 12- and 24-week follow-ups, respectively (p < 0.01 vs. corresponding basal values). Albeit not randomized, this large, prospective study shows that VEL-SMOOTH® treatment may improve sexual function in postmenopausal women suffering from GSM. [ABSTRACT FROM AUTHOR]

Introduction: It was aimed to evaluate the efficacy of two tea tree oil (TTO)-based cleansing gels in chronic blepharitis patients.Methods: Group-1 (basic gel containing 3%(w/w)-TTO) included 50 eyes of 25 patients and group-2 (advanced gel containing 3%(w/w)-TTO plus essential oils and vitamins) included 48 eyes of 24 patients. Ocular Surface Disease Index (OSDI), tear breakup time (TBUT), ocular surface staining pattern, Schirmer's test, impression cytology, Demodex presence and TNF-α, IL-6, IL-1β levels were evaluated at the first visit and 1 month after treatment.Results: In both groups, the mean OSDI score decreased (p1:0.001, p2:0.001), TBUT increased (p1:0.002, p2:0.004). In group-1, Demodex presence decreased from 42% to 27.8%; in group-2 from 54.2% to 20.6% (p1:0.302, p2:0.004). IL-1β and IL-6 decreased in group-2 (p1:0.002, p2:0.050). TNF-α decreased in both groups (p1:0.001, p2:0.001).Conclusion: Both formulations improved ocular surface parameters. Group 2 showed more reduction in tear cytokines and Demodex count. [ABSTRACT FROM AUTHOR]

Objective: We conducted a long-term follow-up study to investigate the time course of residual hearing in our first 21 consecutively operated cochlear implant (CI) patients using the round window (RW) approach . The study may provide additional information about the influence of a flexible lateral wall electrode array on cochlear function. Methods: Data were available for long-term follow-up (>5 years) in 15 patients. Pure tone audiometry (PTA) was assessed at 0.125-8 kHz preoperatively, and at one, three and >5 years postoperatively. Insertion angle, number of electrodes inside the cochlea, user-time of the processor and stimulation strategy were documented. Results: Twelve out of 15 patients had residual hearing after a follow-up period of five years (mean 86 months, range: 61-103 months). Four out of 15 patients had >75% complete hearing preservation (HP), 8 out of 15 had 25-75% partial HP and 3 out of 15 patients had complete loss of hearing. There was a high correlation between insertion angle and HP. Conclusion: Long-term HP was possible in 12 out of 15 cases. Even patients with complete hearing loss at long-term follow-up showed high performance in speech understanding and were full-time users. [ABSTRACT FROM AUTHOR]

Purpose: We performed a meta-analysis to evaluate the effect of uveitis treatment on glaucoma drainage implant surgical outcomes.Methods: We included 16 articles in the meta-analysis. Two groups were defined based on medical therapy of uveitis: Group 1: poorly controlled uveitis, and Group 2: well-controlled uveitis including use of immunomodulatory medications.Results: The two groups were similar in comparisons of follow-up time, age, gender, and etiology of uveitis. Meta-analysis demonstrated significantly greater success in Group 2 (95.1%) compared to Group 1 (81.6%) at 1 year after glaucoma drainage implant surgery (P = .001). The final success was significantly greater (P 0.014) in group 2 compared with group 1 (86.1% and 74.3%, respectively).Conclusion: Surgical success was significantly higher in uveitic glaucoma patients treated with more intensive immunosuppressive therapy before and after glaucoma drainage implant surgery. The level of control of uveitis perioperatively appears to influence glaucoma drainage implant surgery outcomes. [ABSTRACT FROM AUTHOR]

Prolonged pregnancies are associated with foetal and neonatal complications. This study was performed to evaluate the efficacy of intravaginal isosorbide mononitrate (IMN) for cervical ripening in prolonged pregnancies. 122 pregnant women were recruited. Women were assigned to 25 µg sublingual misoprostol plus 40 mg isosorbide mononitrate or placebo. Statistical analysis was done using SPSS software (version 23) and T-test, Mann-Whitney and Chi-square test. p ≤ .05 was considered significant. The mean time between beginning of cervical ripening to Bishop score >6 was significantly shorter in IMN plus misoprostol group when compared to misoprostol plus placebo group (p = .02). The mean time from beginning of cervical ripening to the beginning of active phase of Labour was comparable between two groups (p = .274). The misoprostol plus IMN group had significantly shorter interval from the beginning of cervical ripening to the time of delivery. Isosorbide mononitrate in combination with misoprostol has a promising effect on cervical ripening and progress in labour.IMPACT STATEMENTWhat is already known on this subject? Prolonged pregnancy is associated with foetal, neonatal, and maternal complications. Because of these complications, many obstetricians tend toward the induction of prolonged pregnancies to reduce perinatal morbidity and mortality. Isosorbide mononitrate is a nitric oxide donor agent which is used vaginally for cervical ripening in term pregnancies resulting in various outcomes.What do the results of this study add? Isosorbide mononitrate in combination with misoprostol had a greater effect on cervical ripening and progress in labour than misoprostol alone in prolonged pregnancies.What are the implications of these findings for clinical practice and/or further research? According to results of the current study; using isosorbide mononitrate in combination with misoprostol could enhance successful vaginal delivery in prolonged pregnancy. Evaluation of maternal satisfaction by using this protocol is recommended in future studies. [ABSTRACT FROM AUTHOR]

The aim of the study was to explore whether abstinent patients on recent opioid detoxification or on opioid maintenance treatment suffer from sleeping problems. 199 patients on opioid maintenance treatment (methadone, diacetylmorphine and buprenorphine) or recent opioid detoxification were included in this exploratory cross-sectional study. We used the Pittsburgh Sleep Quality Index (PSQI) and the Regensburger Insomnia Scale (RIS) in order to assess potential sleeping problems. There was a significant effect of the condition "opioid maintenance" or "recent opioid detoxification" on the total score of PSQI and RIS. All opioid maintenance drugs used by the study population were associated with more sleeping problems compared to the detoxification group when calculated with RIS values. Recently abstinent patients (opioid detoxification) displayed significantly fewer sleep disturbances than opioid-maintained patients. Since sleeping problems can seriously impair treatment success and quality of life, screening for sleep disturbances and their subsequent treatment is of pronounced relevance. [ABSTRACT FROM AUTHOR]

Purpose: To study morphology and treatment outcomes in serpiginous-like choroiditis (SLC).Methods: A retrospective chart review of SLC cases with ≥1-year follow-up. SLC lesions with elongated borders, thin body named dendritic (D-SLC), large lesions still with elongated borders named advanced dendritic (AD-SLC), and lesions with rounded borders, thick body called placoid (P-SLC). History, investigations, treatment response, and relapses were studied.Results: Thirty-three eyes [D-SLC (n = 14), AD-SLC (n = 13), P-SLC (n = 6)] of 24 patients were studied. Resolution on Fundus autofluorescence achieved at 8.6 months (Range: 4-12 months). 0/16 eyes treated with anti-tubercular therapy (ATT) and 4/11 eyes treated without ATT had at least one recurrence in (D-SLC + AD-SLC) group (p = .019). Mean best corrected visual acuity at final follow-up was 20/20, 20/25, and 20/60 in D-SLC, AD-SLC, and in P-SLC, respectively.Conclusion: P-SLC has poor visual prognosis compared to AD-SLC and D-SLC. ATT may prevent recurrences in D-SLC and AD-SLC. [ABSTRACT FROM AUTHOR]

Purpose: To evaluate the efficacy and safety of a novel topical cyclosporin A 0.05% nanoemulsion in comparison with a conventional emulsion in primary Sjögren's syndrome dry eyes.Methods: Prospective, randomized, double-blinded study was conducted.Results: Corneal and conjunctival staining score was improved in both groups, with a faster change noted in the nanoemulsion group at 12 weeks (p < 0.05). Tear film break-up time was significantly improved in the nanoemulsion group at 12 weeks (p < 0.05), while ocular surface disease index score was improved in both groups without a difference at 12 weeks. Schirmer I value and goblet cell grade did not change in both groups. IL-6 and MMP-9 were significantly decreased in both groups at 12 weeks.Conclusions: Both nanoemulsion and conventional cyclosporin A improved ocular signs, symptoms, and conjunctival inflammation. However, the novel cyclosporin A nanoemulsion showed faster improvement of ocular surface staining scores than the conventional emulsion. [ABSTRACT FROM AUTHOR]

Objectives: The incidence of Mycobacterium avium complex (MAC) pulmonary disease is increasing worldwide. We conducted a systematic review and meta-analysis to determine the treatment success rate of antibiotic therapy in MAC pulmonary disease and evaluate the effectiveness of aminoglycoside-containing regimens.Methods: We searched literature between 1 January 1980 to 19 June 2019. Studies with diagnosis criteria based on the current guidelines that reported treatment outcomes were included. We defined treatment success as the achievement of culture conversion and completion of the planned treatment without relapse while on treatment.Results: We retrieved 45 studies including 3862 patients. The estimated pooled treatment success rate was 68.1% [95% confidence interval (CI) 64.7-71.4%]. Based on the Cochrane tool, the included studies had a low risk of bias. Forty-two studies reported macrolide-containing regimens, while 6 studies included aminoglycoside-containing regimens. Macrolide-containing regimens led to better treatment success rates comparing to non-macrolide-containing regimens; 69% vs 58.5%, respectively. Treatment duration of 12 months or more showed better results.Conclusion: Poor treatment success rate of MAC pulmonary disease calls for more randomized clinical trials designed based on consensus definitions of the disease diagnosis and treatment. New drugs with a better adherence rate need to be developed.Systematic Review Registration: PROSPERO (pending registration ID: 151674). [ABSTRACT FROM AUTHOR]

Objective: Our institution implemented six multimodal, sliding scale protocols for managing pain in non-surgical inpatients. The purpose of this study was to compare the use of these acute pain protocols with traditional prescribing in regard to pain management efficacy and safety measures.Methods: This retrospective cohort study evaluated hospital in-patients who were prescribed one of the protocols during the first 6 months following implementation, admitted to the hospitalist service, and had received at least two doses of PRN analgesic medication within a 24-hour period. Data collected included baseline demographics, verbal pain rating scores to determine time to achieve analgesia, total opioid use in oral morphine equivalent doses (MEDs), and safety measures. A sample of patients admitted during the same time frame, meeting inclusion/exclusion criteria, but who received traditional analgesic prescribing served as controls.Results: Forty-six adult, non-surgical patients were included in the analysis, and 46 served as controls. The average baseline pain scores were similar between groups (7.26 in protocol, 7.43 in control, p = 0.684). Protocol patients required significantly less time to achieve meaningful analgesia (average 507.52 min) compared to the control group (894.33 min, p = 0.045). Patients in the protocol group used an average of 35.81 MEDs per day compared to 65.77 MEDs in controls (p = 0.019). Patients in the protocol group used significantly fewer PRN analgesic doses (12.70 vs. 24.02, p < 0.0001).Conclusion: Analysis of the implementation of acute pain management protocols indicates that using standardized pain management protocols of opioids, non-opioids, and medications to prevent opioid-related adverse events is more effective than traditional analgesic prescribing for our patient population. [ABSTRACT FROM AUTHOR]

Introduction: Health anxiety, also known as 'hypochondriasis', is a common, distressing and costly condition that responds to cognitive behavior therapy (CBT) but evidence pertaining to response and remission rates, treatment in routine care, therapist-guided Internet-delivered CBT (ICBT) and health economics has not been systematically reviewed.Areas covered: In this systematic review and meta-analysis we searched PubMed, PsycINFO, and OATD (17/06/2019) for randomized controlled trials (RCTs) comparing CBT to non-CBT controls for health anxiety. Based on 19 RCTs, the pooled between-group effect on health anxiety was moderate to large (g = 0.79; 95% CI: 0.57-1.01; adjusted for publication bias: g = 0.62), with small to moderate effects on secondary symptoms and effects largely sustained 12-18 months after treatment. Moderators were control condition and recruitment path, but not treatment setting. The pooled CBT response rate was 66%, and the remission rate 48%. ICBT had effects comparable to face-to-face CBT. CBT for health anxiety is probably cost-effective, but with limited effect on the quality of life.Expert opinion: CBT is a highly efficacious and probably cost-effective treatment for health anxiety. We recommend that ICBT is implemented more widely, and that health economic outcomes and ways of increasing response and remission rates are explored further. [ABSTRACT FROM AUTHOR]

Objetives. Carotid endarterectomy (CEA) is an established treatment for carotid stenosis (CS). However, this procedure is not risk-free and it is insufficient to control disseminated atherosclerosis. Our aim was to determine long-term cardiovascular morbidity and mortality after CEA and identify associated risk predictors. Design. Consecutive cohorts of CEAs performed between 2010 and 2018 in two Portuguese hospitals were retrospectively analysed. The major end-points were acute myocardial infarction (AMI), stroke, all-cause death and major adverse cardiovascular events (MACE). Results. 248 patients (mean age 69 years; 79% male) were enrolled in the study. 24% had postoperative complications. At 52 months median follow-up, 9 ± 2.0% (mean ± standard error) of patients experienced an acute myocardial infarction (AMI), 12 ± 2.4% a stroke and 26 ± 3.2% a MACE. All-cause mortality rate was 21 ± 3.0%. Multivariate analysis identified coronary artery disease (CAD) as significant predictor of AMI (p < .001; Hazard Ratio (HR):9.628; 95% Confidence Interval (95%CI):2.805-33.046), whereas no statistically significant risk factor of stroke was found. Predictors of death included left sided CS (p = .042; HR:1.886; 95%CI:1.024-3.475), chronic kidney disease (CKD) (p = .007; HR:2.352; 95%CI:1.266-4.372) and anticoagulant medication (p = .015; HR:2.107; 95%CI:1.216-6.026), while statin use was significantly protective (p = .049; HR:0.482; 95%CI:0.233-0.998). Concerning MACE, male gender (p = .040; HR:1.709; 95%CI:1.025-2.849), tobacco use (p = .004; HR:2.181; 95%CI:1.277-3.726), CAD (p = .002; HR:2.235; 95%CI:1.340-3.727) and CKD (p < .001; HR:3.029; 95%CI:1.745-5.258) were risk predictors. Conclusions. Patients continue to have high rates of AMI, MACE and death after CEA. Prior CAD is a risk factor for future AMI, whereas CKD is a significant predictor of MACE and death. Aggressive best medical treatment and risk factors modification should be advised in all patients with systemic atherosclerosis. [ABSTRACT FROM AUTHOR]

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Purpose: To conduct a systematic review of effectiveness of pharmacological therapies for treatment of Uveitic Macular Edema (UMO). Method/Design: Comparative studies of pharmacological therapies in patients with UMO were identified in Cochrane CENTRAL/MEDLINE/EMBASE/CINAHL/trials registers (February 2017). PROSPERO registration: CRD42015019170. Results: Thirty-one studies were included. Corticosteroids were the most frequently studied (n = 20). Corticosteroids (all forms) were consistently of greater/equal efficacy to active comparators; for anti-VEGF (n = 4) improvement, best-corrected visual acuity (BCVA) and central macular thickness (CMT) were mostly less than local corticosteroid injection; for interferon (n = 1) improvement BCVA and CMT were greater than the comparator of methotrexate; for topical indomethacin (n = 1) improvement, BCVA and CMT were greater than placebo. Non-steroidal anti-inflammatory drugs, carbonic anhydrase inhibitors, and vitamin E (n = 5) were not effective for these outcomes. Conclusion: The review highlights areas where the evidence base is still lacking, and appropriately focused trials are needed to inform best treatment to tackle this sight-threatening condition. [ABSTRACT FROM AUTHOR]

Purpose: To compare the subclinical inflammatory response (as measured by anterior chamber flare) induced after standard (3 mW/cm2, 30 min) and accelerated (18 mW/cm2, 5 min) corneal cross-linking (CXL). Methods: In this comparative, non-randomized study, patients with progressive keratoconus who underwent standard or accelerated CXL were studied. Laser flare photometery (FM-600; Kowa, Tokyo, Japan) was used to measure anterior chamber flare preoperatively and at 1 week, 1 month, 3 months, and 6 months after the procedure. Results: Sixty eyes of 60 patients were studied; 30 eyes in each group. Mean baseline flare values were 4.15 ± 1.19 and 4.57 ± 2.17 ph/ms in standard and accelerated groups, respectively (p = 0.228).and after surgery increased in all follow-up measurements in the both groups similarly (P > 0.05). Conclusion: Both standard and accelerated CXL results in induction of a subclinical inflammatory response that persists up to 6 month. The response was similar between the two groups. [ABSTRACT FROM AUTHOR]

Background: Discrepancies are seen between arguments in favor of and against prescribing generic versus brand-name drugs.Objective: To provide real-world evidence on treatment persistence, economic and clinical outcomes of pregabalin, generic versus brand-name (Lyrica®, Pfizer), routinely used to treat neuropathic pain (NP) or generalized anxiety disorder (GAD).Methods: Electronic medical records from subjects' first starting treatment with pregabalin between January-2015 and June-2016 were analyzed. Persistence, resources utilization, and costs were assessed, along with remitter and responder rates.Results: A total of 4860 records were analyzed. Discontinuation was lower with brand-name than with generic in NP (adjusted hazard ratio [HR]: 0.70 [95% CI: 0.58-0.85], p < 0.001) and GAD patients (HR: 0.63 [0.45-0.84], p < 0.001). Adjusted mean total costs were lower with brand-name: €1500 [1428-1573] vs. €2003 [1864-2143] in NP and €1528 [1322-1734] vs. €2150 [1845-2454] in GAD (both p < 0.001). More patients were remitters/ responders with brand-name in NP (55.0% vs. 46.7% and 59.2% vs. 48.4%, respectively; p < 0.001) and GAD (58.6% vs. 48.7% and 64.6% vs. 47.2%, respectively; p < 0.001).Conclusions: As a consequence of higher persistence in routine practice, patients who first started therapy with pregabalin brand-name versus generic showed better pain or anxiety outcomes at a lower cost to payers in Spain. [ABSTRACT FROM AUTHOR]

Background: Drug-resistant tuberculosis (DR-TB) continues to be a major public health challenge with suboptimal treatment outcomes including well-documented treatment-related toxicities. We compared the cost-effectiveness of bedaquiline (BDQ) containing regimens with injectable containing regimens (short-course regimen [SCR] and long-course regiman [LCR]) in India, Russia, and South Africa.Methods: The analysis evaluated the direct costs of DR-TB treatment which included drugs, hospitalization, injectable-related adverse event costs, and other costs. Scenarios altered regimen costs, SCR/LCR ratio, and substitution rate between regimens (whether BDQ or injectable containing).Results: BDQ containing regimens are more cost effective based on cost per treatment success compared with injectable containing regimens, reducing these in SCR by 18-20% and in LCR by 49-54%. Average cost effectiveness ratios (ACERs) of BDQ containing regimens are lower. The incremental cost effectiveness ratio (ICER) is negative. Exclusive use of BDQ containing regimens results in approximately 61,000 more patients treated successfully over 5 years.Conclusions: Across all countries, BDQ containing regimens are dominant compared to injectable containing regimens, entailing lower treatment costs to achieve better clinical outcomes. This analysis can provide insight and support to local and global decision-makers and public health organizations to allocate efficiently resources improving patient and public health outcomes. [ABSTRACT FROM AUTHOR]

Introduction: A systematic review was performed to explore the health-related quality of life (HRQoL) outcomes among cancer patients receiving PD-(L)1 inhibitors compared to those receiving traditional cytotoxic therapy. Areas covered: Citations from PubMed and the American Society of Clinical Oncology meeting library were examined. Cross-references from original studies and review articles were also reviewed. Eligible trials included randomized controlled trials of cancer patients treated with one of the PD-(L)1 inhibitors and reporting HRQoL outcomes. A total of 11 studies were included in the current review. PD-(L)1 inhibitors were associated with a consistent prolongation of the time to symptomatic deterioration. This was shown with the three agents (nivolumab, pembrolizumab, and atezolizumab) as well as across a variety of solid tumors (lung cancer, melanoma, head and neck cancer and urothelial cancer). Moreover, PD-(L)1 inhibitor therapy was associated with better symptomatic control at different follow-up points. This was observed regardless of the agent used of the solid tumor treated. Expert commentary: Across a variety of solid tumor indications as well as a variety of PD-(L)1 inhibitors, the use of PD-(L)1 inhibitors is associated with an improvement in the quality of life. The utility of patient-reported outcomes in predicting clinical benefit from these agents needs to be explored further. [ABSTRACT FROM AUTHOR]

Purpose: The purpose of this article is to demonstrate the superiority of gevokizumab as compared to placebo, on top of current standard of care, in reducing the risk of Behçet's disease uveitis (BDU) exacerbations.Methods: Randomized, double-masked, placebo-controlled, parallel group, event-driven trial in BDU patients having recently experienced an ocular exacerbation, subsequently undergoing a tapering procedure from high-dose corticosteroids and receiving 60 mg gevokizumab or placebo every 4 weeks subcutaneously (EYEGUARD B-ClinicalTrials.gov NCT 01965145).Results: A total of 83 patients (40 gevokizumab, 43 placebo) were included. Gevokizumab did not significantly affect the risk of occurrence of ocular exacerbations. However, data suggested that gevokizumab could preserve visual acuity, reduce the uveitis severity, decrease the emergence of macular edema, and have a corticosteroid sparing effect. Gevokizumab was well tolerated.Conclusions: While the primary efficacy endpoint was not met with gevokizumab, the control of IL-1β pathway in patients with BDU may still be a relevant target. [ABSTRACT FROM AUTHOR]

Purpose: TNF alpha inhibitors have revolutionized the care of vision-threatening uveitis. This study evaluated the efficacy of adalimumab (ADA) for the treatment of refractory noninfectious uveitis.Design: Randomized, prospective, controlled, two-center clinical trial Methods: Patients with active uveitis despite combined oral low-dose prednisolone and immunosuppression were randomized for additional ADA with corticosteroids in a fixed tapering regime, or corticosteroids only. Primary outcome measure at three months was improved best-corrected visual acuity (BCVA; >2 lines). In case of treatment failure, switch to the other arm was possible.Results: Twenty-five patients (10 ADA, 15 controls) were included. BCVA increased with ADA by > 2 lines in 6/10 patients (60%; mean increase of 0.23 logMAR), but in only 2/15 from controls (13%, mean increase of 0.04 logMAR, Fisher´s exact test p = 0.00221).Conclusions: The results show superiority of ADA over controls in severe ocular inflammation including anterior uveitis. [ABSTRACT FROM AUTHOR]

Tubo-ovarian abscess (TOA) coexists in 15% of cases with pelvic inflammatory disease. Medical treatment is the first line of approach in women with TOA, however, 25% of cases fail to respond to antibiotics, therefore, these cases need to undergo surgical intervention. We aimed to determine factors leading to failure of medical treatment in women diagnosed with TOA. According to our results among 144 women, 27 cases required surgical intervention for full recovery. None of the demographic, sonographic or laboratory findings, including procalcitonin level, had significant predictive value for the failure of medical treatment in women with TOA. Impact statement What is already known on this subject? Tubo-ovarian abscess (TOA) coexists in 15% of cases with pelvic inflammatory disease. Medical treatment is the first line approach in women with TOA, however, 25% of cases fail to respond to antibiotics, therefore, these cases need to undergo surgical intervention. Several risk factors have been evaluated in order to predict the failure of medical treatment. What do the results of this study add? None of the variables, including age, parity, mass diameter, serum CRP, procalcitonin levels and sedimentation rate had significant value for predicting TOA cases that required surgical intervention for full recovery. What are the implications of these findings for clinical practice and/or further research? In clinical practice, identification of risk factors leading to the failure of medical treatment helps clinicians to inform patients and help surgeons predict those who need surgical intervention. [ABSTRACT FROM AUTHOR]

Introduction: A significant number of patients undergo upgrade to cardiac resynchronization therapy (CRT). These patients tend to differ from individuals undergoing de novo CRT implantations both in terms of their baseline demographics and the etiology underlying their heart failure. Areas covered: There are several factors that need to be considered when upgrading patients to CRT, such as, venous patency. Potentially, these conditions can cause issues which may result in procedures being more difficult than de novo implantations. This article discusses these issues and compares the rates of procedural-related complications for CRT upgrades and de novo implantations. It discusses the proportion of patients that are likely to respond to CRT with each intervention. Expert commentary: Understanding the relative risks of CRT upgrades versus de novo implantations is important to help operators select the correct initial device and counsel patients accordingly. Growing experience with image-guided implantations and endocardial pacing may prove to be particularly relevant to patients undergoing CRT upgrades. [ABSTRACT FROM AUTHOR]

Introduction: Trastuzumab is a key drug in the neoadjuvant treatment of breast cancers that overexpress the human epidermal growth factor receptor 2 (HER2). Pathological complete response (pCR) is commonly used as an endpoint in neoadjuvant clinical trials of trastuzumab as evidence suggests it may be a surrogate for long-term survival. Several biosimilar candidates of originator or 'reference' trastuzumab are in development and have used pCR as a primary endpoint to assess therapeutic equivalence between treatments. The exact definition of pCR has varied across studies. Areas covered: Here we look at the clinical relevance of pCR and compare rates of total pCR (defined as ypT0/is ypN0) and breast pCR (defined as ypT0/is) in clinical trials of reference and biosimilar trastuzumab. Expert commentary: In order to evaluate the efficacy of neoadjuvant systemic therapies in a uniform way, standardization of trial endpoints is necessary. Future studies in HER2-positive breast cancer should include full assessment of the breast and lymph node basin before and after neoadjuvant systemic therapy, and the use of total pCR as the primary outcome. [ABSTRACT FROM AUTHOR]

Objectives: To investigate whether, apart from effects of patient- and disease-related factors, psychosocial factors have additional effects on disease activity; and which factors are most influential during the first year of treatment in early rheumatoid arthritis (RA).Method: The study assessed 15 month follow-up data from patients in tREACH, a randomized clinical trial comparing initial triple disease-modifying anti-rheumatic drug therapy to methotrexate monotherapy, with glucocorticoid bridging in both groups. Patients were evaluated every 3 months and treated to target. Associations between Disease Activity Score (DAS) at 3, 9, and 15 months and psychosocial factors (anxiety, depression, fatigue, and coping with pain) at the previous visit were assessed by multivariable linear regression correcting for demographic, clinical, and treatment-related factors.Results: At 3, 9, and 15 months of follow-up, 265, 251, and 162 patients, respectively, were available for analysis. Baseline anxiety and coping with pain were associated with DAS at 3 months; coping with pain at 6 months was associated with DAS at 9 months, and fatigue at 12 months with DAS at 15 months. Psychosocial factors were moderately correlated. Effects on DAS were mainly due to tender joint count and global health.Conclusion: Psychosocial factors have additional effects on DAS throughout the first year of treatment in early RA. A change was observed from anxiety and coping with pain at baseline being associated with subsequent DAS towards fatigue being associated with subsequent DAS at 12 months. Owing to the explorative nature of this study, more research is needed to confirm this pattern. [ABSTRACT FROM AUTHOR]

Purpose: To investigate the feasibility of a study based on treatment with topiramate (TPM) added to moderate hypothermia in newborns with hypoxic ischemic encephalopathy (HIE).Materials and Methods: Multicenter randomized controlled trial. Term newborns with precocious metabolic, clinical and electroencephalographic (EEG) signs of HIE were selected according to their amplified integrated EEG pattern and randomized to receive either TPM (10 mg/kg once a day for the first three days of life) plus moderate hypothermia or hypothermia alone. Safety was assessed by monitoring cardiorespiratory parameters and blood samples collected to check renal, liver, metabolic balance and TPM pharmacokinetics. Efficacy was evaluated by the combined frequency of mortality and severe neurological disability as primary outcome. Incidence of magnetic resonance injury, epilepsy, blindness, hearing loss, neurodevelopment at 18-24 months of life was assessed as secondary outcomes.Results: Forty-four asphyxiated newborns were enrolled in the study. Twenty one newborns (10 with moderate and 11 with severe HIE) were allocated to hypothermia plus TPM and 23 (12 moderate and 11 severe HIE) to hypothermia. No statistically or clinically significant differences were observed for safety, primary or secondary outcomes. However, a reduction in the prevalence of epilepsy was observed in newborns co-treated with TPM.Conclusions: Results of this pilot trial suggest that administration of TPM in newborns with HIE is safe but does not reduce the combined frequency of mortality and severe neurological disability. The role of TPM co-treatment in preventing subsequent epilepsy deserves further studies. [ABSTRACT FROM AUTHOR]

We analyzed outcome of women screened for preeclampsia with two different multifactorial risk algorithms (Predictor®Software by PerkinElmer, PerkinElmer, Waltham, MA; PERK-group:n = 214 and Viewpoint®by GE Healthcare, Dornstadt, Germany; VIEW-group:n = 209) in first trimester. Women at high risk for developing preeclampsia were advised to take low-dose acetylsalicylic acid (LDA). Screening positive rates for early onset preeclampsia differed significantly between the two groups (7.9% versus 26.3%;p = 0.000). According the clinical use of screening test criteria, LDA was prescribed in 63 (29.4%) women in the PE-group and 55 (26.3%) in the VP-group (p = 0.516). There were no differences in onset of preeclampsia [4 (1.9%) versus 6 (2.9%);p = 0.540]. No early or severe preeclampsia occurred in the whole population. [ABSTRACT FROM PUBLISHER]

Objective: To determine whether radical prostatetomy (RP) is suitable for prostate cancer patients with age ≥75 years in comparison to primary androgen deprivation therapy (PADT).Patients and Methods: A cohort study was conducted in clinically localized prostate cancer patients with ≥75 years of age who underwent RP or PADT at six institutions from 2005 to 2013. Patients who had less than 12 months of follow-up, or received neoadjuvant or adjuvant therapy were excluded. We compared clinical characteristics, cancer-specific and overall survivals, and post-treatment complication rates between two groups.Results: We included 92 and 99 patients in the RP and PADT groups, respectively. In survival analyses, there were no significant differences in cancer-specific and overall survivals (p = .302 and .995, respectively). The incidence of serious adverse events (cardio- or cerebrovascular event, or bone fracture) was higher in the PADT group (p = .001). Multivariable analysis showed that PADT had a worse effect on the serious adverse events (OR 10.12, p = .038).Conclusions: In selected elderly patients, RP was safe and effective for treatment of localized prostate cancer, as compared to PADT. Surgical treatment options should be considered in elderly patients with respect to life expectancy, rather than chronological age. [ABSTRACT FROM AUTHOR]

Background: Neuraminidase inhibitors (NAIs) reduce influenza symptoms but clear evidence of relationships between viral titer reduction and symptom alleviation is lacking. This open-label, randomized study evaluated differences in viral dynamics between NAIs, and relationships between viral dynamics and influenza symptoms (trial registration number: UMIN000012670).Methods: Patients (n = 123) aged 4-12 years with influenza A virus infection were randomized to intravenous peramivir, oral oseltamivir, inhaled zanamivir, or inhaled laninamivir. Patients received regular viral assessments of nasal discharge, at least until rapid antigen tests were negative. Time to virus clearance, based on influenza virus titer, was the primary endpoint.Results: Peramivir recipients had a significantly shorter time to virus clearance than oseltamivir recipients (adjusted p = 0.035). Comparisons between the peramivir group and other NAI groups were not significant. There were no significant inter-group differences in other clinical efficacy endpoints (time to resolution of fever, time to alleviation of symptoms). However, the peramivir group showed a smaller numerical proportion of relapses with fever or positive virus than the other groups.Conclusions: The time to virus clearance was significantly shorter with peramivir than with oseltamivir. Although no clear relationship between virus dynamics and symptoms was observed, ongoing studies should clarify the situation. [ABSTRACT FROM AUTHOR]

Introduction: The proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor is a new treatment option for patients with hypercholesterolemia. The objective of this study was to systematically review the cost-effectiveness of lipid-lowering agents.Areas Covered: Based on Pubmed, Embase, and Cochrane Database of Systematic Reviews, we identified 29 relevant articles. Studies found statins were cost-effective compared with placebo or no treatment in general. Atorvastatin was reported to be cost-effective against simvastatin. In most cases, rosuvastatin was more cost-effective than atorvastatin or simvastatin. Additionally, ezetimibe was considered to be cost-effective compared with no treatment for statin intolerant patients. For patients not meeting treatment goals with their statins, switching to ezetimibe plus simvastatin was consistently reported cost-effective. The cost-effectiveness of ezetimibe plus a hybrid of a statin varied by the source of clinical data and cost of ezetimibe. Finally, the cost-effectiveness of PCSK9 inhibitor plus a statin against statin monotherapy was uncertain. The PCSK9 inhibitor plus a stain was cost-ineffective compared with ezetimibe plus a statin.Expert Commentary: Drug costs and treatment efficacy were the key drivers of the cost-effectiveness results in prior analyses. Future evaluations are warranted to reflect the decreasing drug prices and the long-term treatment effects of PCSK9 inhibitors. [ABSTRACT FROM AUTHOR]