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Copyright of Developmental Medicine & Child Neurology is the property of Wiley-Blackwell and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

The present paper reports on a 5-year follow-up of a randomized reading intervention in grade 3 in Sweden. An intervention group (n = 57) received daily training for 12 weeks in phoneme/grapheme mapping, reading comprehension and reading speed, whereas a control group (n = 55) participated in ordinary classroom activities. The main aim was to investigate if there were remaining effects of the intervention on reading-related skills. Previous analyses showed that the intervention group performed significantly better than the control group on spelling, reading speed, reading comprehension and phoneme awareness at the immediate post-test with sustained effects 1 year later. Results from the 5-year follow-up show that the only significant difference between the intervention (n = 47) and the control group (n = 37) was on word decoding. There was also a significant interaction effect of group assignment and initial word decoding, in the way that the lowest-performing students benefitted the most from the intervention. Another aim was to examine if the children identified in a screening (n = 2212) as poor readers in grade 2 still performed worse than typical readers. The analyses showed that the typically developing students (n = 66) outperformed the students identified as poor readers in grade 2 on working memory, spelling, reading comprehension and word decoding. Copyright © 2016 John Wiley & Sons, Ltd. [ABSTRACT FROM AUTHOR]

It is common for longitudinal clinical trials to face problems of item non-response, unit non-response, and drop-out. In this paper, we compare two alternative methods of handling multivariate incomplete data across a baseline assessment and three follow-up time points in a multi-centre randomized controlled trial of a disease management programme for late-life depression. One approach combines hot-deck (HD) multiple imputation using a predictive mean matching method for item non-response and the approximate Bayesian bootstrap for unit non-response. A second method is based on a multivariate normal (MVN) model using PROC MI in SAS software V8.2. These two methods are contrasted with a last observation carried forward (LOCF) technique and available-case (AC) analysis in a simulation study where replicate analyses are performed on subsets of the originally complete cases. Missing-data patterns were simulated to be consistent with missing-data patterns found in the originally incomplete cases, and observed complete data means were taken to be the targets of estimation. Not surprisingly, the LOCF and AC methods had poor coverage properties for many of the variables evaluated. Multiple imputation under the MVN model performed well for most variables but produced less than nominal coverage for variables with highly skewed distributions. The HD method consistently produced close to nominal coverage, with interval widths that were roughly 7 per cent larger on average than those produced from the MVN model. [ABSTRACT FROM AUTHOR]

Background: Droperidol and 5-HT3-receptor antagonists are among the most potent antiemetics to prevent postoperative nausea and vomiting (PONV). Combinations of these drugs have been used to increase the efficacy of antiemetic treatment. However, so far the quantitative effect of this combination has not been evaluated systematically. Methods: Results from randomised controlled trials investigating the efficacy of 5-HT3-receptor antagonists or droperidol alone versus the combination of both drugs to prevent PONV were included in a meta-analysis. Studies were systematically searched using Medline, EMBASE, the Cochrane-Library, and by manually screening the reference lists of matching review articles and current issues of locally available peer-reviewed anaesthesia journals. Seven papers with data on granisetron published by Fujii and co-workers were not considered. The main end point in each study was defined as occurrence of nausea, retching, or vomiting within 6 h (“early PONV”) and within 48 h (“late PONV”) after surgery. The relative risks (RR) and the numbers needed to treat (NNT) of the pooled data with their corresponding 95% confidence intervals (given in parentheses) were calculated using a random effects model. Results: Eight studies with 881 patients (adults: n=801; children (mean age: 8 yr): n=80) were included in the analysis. Droperidol was applied to 340 patients, 5-HT3-receptor antagonists to 198, and 343 were treated with a combination of both drugs. Seven out of these eight studies reported increased antiemetic efficacy of the combination group compared with the single drugs (droperidol and 5-HT3-receptor antagonists respectively). However, in none of the trials did this difference reach statistical significance. When a meta-analytic analysis based on these results was performed the combination of droperidol with a 5-HT3-recpetor antagonist was not associated with a significantly increased antiemetic efficacy. In 12 to 13 patients a 5-HT3-receptor antagonist has to be added to droperidol prophylaxis to prevent one additional patient from PONV who would have had suffered from PONV when treated with droperidol alone (RR “early PONV”: 1.52 (0.95–2.44); RR “late PONV”: 1.24 (0.89–1.74)). Similar results were obtained when the antiemetic effect of adding droperidol to a prophylaxis with 5-HT3-receptor antagonists was analysed. In this case 10 to 12 patients have to be treated with the 5-HT3-droperidol combination instead of with a 5-HT3-receptor antagonist alone to prevent one additional patient from PONV (RR “early PONV”: 1.55 (0.68–3.52); RR “late PONV”: 1.29 (0.77–2.17)). There were no reports of an increased incidence of adverse effects. Conclusion: The data on the combination of droperidol with 5-HT3-receptor antagonists suggest that there is a trend towards increased efficacy of the combination therapy compared to the single drugs. However, so far there are insufficient data to recommend this combination treatment for prophylaxis. [ABSTRACT FROM AUTHOR]

Background: Haemodialysis plastic cannulae have been limited to incident arterio‐venous fistulae cannulation or in those who require a more flexible in situ access device. The feasibility of plastic cannulae in prevalent patients on haemodialysis has not been reported. Objective: To determine the feasibility of plastic cannulae in prevalent haemodialysis patients. Design: Prospective feasibility crossover randomised control trial. Participants: Adults diagnosed with chronic kidney disease G5 requiring haemodialysis three or more times per week via a native arteriovenous fistula previously cannulated for at least 6 weeks. Measurements: Cannulation success rate, cannulation manipulation type, arterial and venous needle pressure. Patient needle‐related anxiety as measured by the 4‐item Patient Health Questionnaire and Meditation in Dialysis Questionnaire and nurse satisfaction. Results: Eight patients completed 12 weeks plastic canulae and metal needles. Plastic cannulae were less likely to be successful in cannulation compared to metal needles (odds ratio = 0.15; 95% confidence interval [CI]: 0.05–0.48; p = 0.001). There was no effect of type of needle on the change in arterial needle pressure or change in venous needle pressure and no effect of plastic needle on repositioning (relative risk [RR] = 1.09; 95% CI: 0.385, 3.089; p =.871) or gauze pillow application (RR = 0.936; 95% CI: 0.467, 1.874; p =.851) than metal needles, relative to no manipulation. There were low rates of psychological distress or needle‐related anxiety towards plastic or metal needles. Conclusions: Plastic cannulae are feasible in prevalent haemodialysis patients, however, metal needles are still preferred in a haemodialysis center that has historically used metal needles. [ABSTRACT FROM AUTHOR]

Background and Objectives: We examined youth recovery outcomes at 6- and 9-months post-participation in an aftercare pilot study called Educating and Supporting inQuisitive Youth in Recovery (ESQYIR) that aimed to investigate the utility of a 12-week mobile texting recovery support intervention.Methods: A total of 80 youth [Mage 20.4 (SD = 3.5)] were randomized to a mobile texting aftercare intervention or an aftercare-as-usual control group. Both groups received identical data collection protocols with psychosocial and behavioral assessments occurring at baseline, during the trial (months 1 and 2), at discharge from the trial (month 3), and 3-, 6-, and 9-month post-intervention follow-ups.Results: Mixed modeling showed that youth who participated in the mobile texting aftercare intervention were less likely to test positive for their primary drug compared to youth in the aftercare-as-usual condition during 6- and 9-months follow-ups (p < .01). Additionally, youth in the aftercare intervention reported significantly higher self-efficacy/confidence to abstain during recovery (p < .05) and were more likely to participate in recovery-related behaviors (self-help and goal-directed extracurricular activities; p < .05) than those in aftercare-as-usual at the 6- and 9-month follow-ups.Conclusions: Results suggest that delivering a structured, behavioral-based wellness aftercare intervention using mobile texting can be an effective for sustaining recovery outcomes in youth over time compared to youth who receive aftercare-as-usual.Scientific Significance: This study shows that a mobile-texting aftercare intervention sustained effects at 6- and 9-months post-intervention for young people in substance use recovery. [ABSTRACT FROM AUTHOR]

Background: Metacognitive training for depression (D‐MCT) is a novel low‐intensity group training for economic treatment of depression. Previous studies demonstrate its efficacy in moderately depressed outpatients. The present study evaluated efficacy and patients' perspective of the D‐MCT in severely depressed psychiatric inpatients. Methods: In a randomized‐controlled trial, 75 individuals with a major depressive disorder (MDD) were allocated to D‐MCT versus euthymic therapy as add‐on (twice a week) to cognitive‐behavioural‐based (CBT) inpatient‐care. Depressive symptoms (HDRS, BDI), dysfunctional (meta)cognition (DAS, MCQ‐30) and subjective appraisal were assessed at baseline, 4 weeks (post) and 3 months (follow‐up). Results: Participants in both conditions showed a large decline in depression at post and follow‐up‐assessment. No superior add‐effect of D‐MCT versus active control emerged for depression severity on top of the inpatient care. However, among patients with a diagnosis of MDD with no (vs. at least one) comorbidity, D‐MCT participants showed a larger decline in depressive (meta‐)cognition at follow‐up with medium‐to‐large effect sizes. D‐MCT was evaluated as superior in overall appraisal, treatment preference, motivation and satisfaction. Limitations: The follow‐up time interval of 3 months may have been too short to detect long‐term effects. There is emerging evidence that modification of (meta)cognition unfolds its full effects only with time. Effects of CBT inpatient‐care on outcome parameters cannot be differentiated. Conclusions: Although D‐MCT as an add‐on was not superior in complete case analyses, results suggest greater benefit for patients with MDD and no comorbidity. D‐MCT proved feasible in acute‐psychiatric inpatient‐care and was highly accepted by patients. Future studies should investigate the role of modified (meta)cognition on long‐term treatment outcome, including dropout and relapse rates. [ABSTRACT FROM AUTHOR]

Background and Purpose: The major drug-metabolizing enzymes for the oxidation of oxycodone are CYP2D6 and CYP3A. A high interindividual variability in the activity of these enzymes because of genetic polymorphisms and/or drug-drug interactions is well established. The possible role of an active metabolite in the pharmacodynamics of oxycodone has been questioned and the importance of CYP3A-mediated effects on the pharmacokinetics and pharmacodynamics of oxycodone has been poorly explored.Experimental Approach: We conducted a randomized crossover (five arms) double-blind placebo-controlled study in 10 healthy volunteers genotyped for CYP2D6. Oral oxycodone (0.2 mg x kg(-1)) was given alone or after inhibition of CYP2D6 (with quinidine) and/or of CYP3A (with ketoconazole). Experimental pain (cold pressor test, electrical stimulation, thermode), pupil size, psychomotor effects and toxicity were assessed.Key Results: CYP2D6 activity was correlated with oxycodone experimental pain assessment. CYP2D6 ultra-rapid metabolizers experienced increased pharmacodynamic effects, whereas cold pressor test and pupil size were unchanged in CYP2D6 poor metabolizers, relative to extensive metabolizers. CYP2D6 blockade reduced subjective pain threshold (SPT) for oxycodone by 30% and the response was similar to placebo. CYP3A4 blockade had a major effect on all pharmacodynamic assessments and SPT increased by 15%. Oxymorphone C(max) was correlated with SPT assessment (rho(S)= 0.7) and the only independent positive predictor of SPT. Side-effects were observed after CYP3A4 blockade and/or in CYP2D6 ultra-rapid metabolizers.Conclusions and Implications: The modulation of CYP2D6 and CYP3A activities had clear effects on oxycodone pharmacodynamics and these effects were dependent on CYP2D6 genetic polymorphism. [ABSTRACT FROM AUTHOR]

Buprenorphine was registered in Australia as a maintenance and detoxification agent for the management of opioid dependence in November, 2000, and became widely available in August, 2001. This paper provides an overview of key developments in the introduction of buprenorphine treatment in Australia, with an emphasis upon the delivery of services in community-based (primary care) settings. A central study in this work was the Buprenorphine Implementation Trial (BIT), a randomized, controlled trial comparing buprenorphine and methadone maintenance treatment delivered under naturalistic conditions by specialist and community-based service providers (general practitioners and community pharmacists) in 139 subjects across nineteen treatment sites. In addition to conventional patient outcome measures (treatment retention, drug use, psychosocial functioning, and cost effectiveness), the BIT study also involved the development and evaluation of clinical guidelines, training programs for clinicians, and client literature, which are described here. Integration of treatment systems (methadone with buprenorphine, specialist and primary-care programs) and factors thought to be important in the uptake of buprenorphine treatment in Australia since registration are discussed. [ABSTRACT FROM AUTHOR]

Explosive strength and balance training are commonly applied to enhance explosive strength and balance performance. Even though both training methods are frequently implemented, ordering effects have largely been neglected. Therefore, the present study aimed to investigate ordering effects of balance and explosive strength training on explosive strength and balance performance as well as changes in short‐interval intracortical inhibition (SICI). Two groups of subjects either participated in 4 weeks of balance training followed by 4 weeks of explosive strength training (BT‐ET) or vice versa (ET‐BT). Before, after 4 and 8 weeks, balance performance, as well as explosive strength, was tested. Additionally, SICI was tested during rest as well as during balance perturbations and explosive contractions. The results show a training specific increase in performance with an increase in balance control followed by an increase in explosive strength in the BT‐ET, while the ET‐BT increased its balance and explosive strength in the opposite order. There were no significant ordering effects. Both groups showed a significant decrease in SICI during the explosive contractions after the eight weeks of training. When SICI was tested during the balance perturbations, SICI initially increased after the first 4 weeks of training but returned to baseline until the end of the eight weeks. It is suggested that the decrease in SICI with prolonged training might show a disengagement of the motor cortex during the balance task. During the explosive contractions, the low SICI levels are beneficial to provide the necessary level of excitatory cortical drive. [ABSTRACT FROM AUTHOR]

This randomized controlled trial examined the effectiveness of Emotionally Focused Therapy (EFT) for depression and relationship satisfaction versus usual care (i.e., couple therapy other than EFT), and explored mechanisms of change. Mixed model trajectory analyses of 16 couples indicated EFT was associated with greater improvement in relationship satisfaction among men and women. Men receiving EFT reported greater improvements in depressive symptoms compared to usual care. Unified structural equation modeling revealed changes in relationship satisfaction preceded changes in depressive symptoms in one cluster of partners, while changes in depression preceded changes in relationship satisfaction in a second cluster. Two other clusters reported simultaneous changes in satisfaction and depression. This study provides encouraging results on the effectiveness of EFT for depression, and insight into mechanisms of change. [ABSTRACT FROM AUTHOR]

Introduction: The role of the radioprotector amifostine in ameliorating radiotherapy side effects in head and neck squamous cell carcinoma (HNSCC) is controversial. This trial aimed to determine whether pretreatment with amifostine reduced the incidence of Radiation Therapy Oncology Group grade ≥2 acute and late xerostomia in patients receiving definitive or adjuvant radiotherapy for HNSCC, without reducing tumour control or survival.Methods: Between 14 September 2001 and 8 November 2004, 44 Royal Adelaide Hospital patients were randomized double-blind to receive amifostine (200 mg/m2 IV) or placebo (normal saline IV) 5 days/week, prior to standard radiotherapy (60-70 Gy), each having ≥75% of the parotids treated to ≥40 Gy. Side effects were assessed weekly during treatment, at 3 and 5 months after radiotherapy, then every 6 months until disease progression or death.Results: The accrual target was 200 patients over 4-5 years, but the trial closed prematurely when only 44 patients had been randomized after 3 years. Of 41 evaluable patients, 80% (16/20) in the amifostine arm had grade ≥2 acute radiation salivary toxicity versus 76% (16/21) in the placebo arm (P = 1.00). The rate of grade ≥2 late radiation salivary toxicity at 12 months was 66% in the amifostine arm and 82% in the placebo arm (estimated hazard ratio 1.61, 95% confidence interval 0.74-3.49, P = 0.22). Other toxicities tended to be worse in the amifostine arm: acute grade 3-4 skin 35% vs 5% and mucous membrane 40% vs 5%; grade ≥2 vomiting 35% vs 5%, hypocalcaemia 25% vs 5% and fatigue 85% vs 33%, with only the latter retaining statistical significance after adjusting for multiple comparisons. There were no significant differences in failure-free (P = 0.70) or overall survival (P = 0.86), with estimated 4-year rates of 48% vs 54% and 49% vs 59% for the amifostine vs placebo arms respectively.Conclusion: There was no clear evidence that pretreatment with amifostine made any difference to the incidence of grade ≥2 acute or late xerostomia. Other toxicity tended to be more severe with amifostine. There was no effect on failure-free or overall survival. Acknowledging the low statistical power, these results do not support the use of IV amifostine pre-radiotherapy in HNSCC. [ABSTRACT FROM AUTHOR]

Objective: To determine whether oral clindamycin reduces the risk of preterm birth (PTB) in women with abnormal vaginal microflora as evidenced by a vaginal pH ≥5.0.Design: Randomised double-blind placebo-controlled trial.Setting: Rural southern India.Population: Pregnant women with a singleton fetus between 13+0/7 weeks and 20+6/7 weeks.Methods: Pregnant women were recruited during prenatal visits in Karnataka, India, from October 2013 to July 2015. Women were required to have a singleton fetus between 13+0/7 weeks and 20+6/7 weeks and an elevated vaginal pH (≥5.0) by colorimetric assessment. Participants were randomised to either oral clindamycin 300 mg twice daily for 5 days or an identical-appearing placebo.Main Outcome Measures: The primary outcome was the incidence of PTB, defined as delivery before 37+0/7 weeks.Results: Of the 6476 screened women, 1727 women were randomised (block randomised in groups of six; clindamycin n = 866, placebo n = 861). The demographic, reproductive, and anthropomorphometric characteristics of the study groups were similar. Compliance was high, with over 94% of capsules being taken. The rate of PTB before 37 weeks was comparable between the two groups [clindamycin 115/826 (13.9%) versus placebo 111/806 (13.8%), between-group difference 0.2% (95% CI -3.2 to 3.5%, P = 0.93)], as was PTB at less than 34 weeks [clindamycin 40/826 (4.8%) versus placebo group 37/806 (4.6%), between-group difference 0.3% (95% CI -1.8 to 2.3%, P = 0.81)]. No differences were detected in the incidence of birthweight of<2500 g, <1500 g, miscarriage, stillbirth or neonatal death.Conclusion: In this setting, oral clindamycin did not decrease PTB among women with vaginal pH ≥5.0.Tweetable Abstract: Oral clindamycin between 13+0/7 and 20+6/7 weeks does not prevent preterm birth in women with a vaginal pH ≥5.0. [ABSTRACT FROM AUTHOR]

Abstract: Small‐quantity lipid‐based nutrient supplements (SQ‐LNS) have been studied in efficacy and effectiveness trials, but little is known about how parents perceive the products and their effects. In a randomised trial in Ghana, efficacy of SQ‐LNS provided to women during pregnancy and the first 6 months postpartum and to their children from 6 to 18 months of age was assessed by comparison with iron‐folic acid (IFA) capsules and multiple micronutrient (MMN) capsules provided to women. In a follow‐up study conducted when the index children from the original trial were between 4 and 6 years of age, we used survey‐based methods to assess retrospective and current parental perceptions of nutrient supplements generally and of SQ‐LNS and their effects compared with perceptions IFA and MMN capsules. Most parents perceived that the assigned supplements (SQ‐LNS, IFA, or MMN) positively impacted the mother during pregnancy (approximately 89% of both mothers and fathers) and during lactation (84% of mothers and 86% of fathers). Almost all (≥90%) of mothers and fathers perceived that the assigned supplement positively impacted the index child and expected continued positive impacts on the child's health and human capital into the future. A smaller percentage of parents perceived negative impacts of the supplements (7%–17% of mothers and 4%–12% of fathers). Perceptions of positive impacts and of negative impacts did not differ by intervention group. The results suggest that similar populations would likely be receptive to programs to deliver SQ‐LNS or micronutrient capsules. [ABSTRACT FROM AUTHOR]

Aims: A network meta-analysis (NMA) of all recommended drug groups for the treatment of heart failure with reduced ejection fraction (HFrEF), including their combinations, was performed to assess the relative efficacy and incremental benefit.Methods and Results: A search was made in biomedical databases for randomized controlled trials published between 1987 and 2017 on angiotensin-converting enzyme inhibitors (ACEIs), beta-blockers (BBs), angiotensin receptor blockers (ARBs), mineralocorticoid receptor antagonists (MRAs), ivabradine (IVA), or angiotensin receptor-neprilysin inhibitors (ARNI). A total of 58 relevant trials were identified. The relative efficacy of each treatment group (or combination) in terms of all-cause mortality, cardiovascular mortality, all-cause hospitalizations and hospitalizations for heart failure, per patient-year of follow-up, were combined in a random-effects Bayesian NMA. The pairwise comparison between each regimen and for each outcome was estimated. The NMA was dominated by 15 large-scale trials with between 1984 and 18 898 patient-years of follow-up. Combinations of drug groups showed incremental benefits on outcomes over single groups. The most effective combinations were ARNI+BB + MRA and ACEI+BB + MRA + IVA, showing reductions in all-cause mortality (vs. placebo) of 62% and 59%, respectively; hazard ratios were 0.38 [credible interval (CrI) 0.20-0.65] and 0.41 (CrI 0.21-0.70); and in all-cause hospitalizations with reductions of 42% for both. These two combinations were also the most effective for the other outcomes studied.Conclusion: Our analysis shows that the incremental use of combinations of disease-modifying therapies has resulted in the progressive improvement in mortality and hospitalization outcomes in HFrEF. Our findings support the current guideline recommendations. [ABSTRACT FROM AUTHOR]

We report the rationale and design of a community PHARMacy-based prospective randomized controlled interdisciplinary study for ambulatory patients with Chronic Heart Failure (PHARM-CHF) and results of its pilot study. The pilot study randomized 50 patients to a pharmacy-based intervention or usual care for 12 months. It demonstrated the feasibility of the design and showed reduced systolic blood pressure in the intervention group as indicator for improved medication adherence. The main study will randomize patients ≥60 years on stable pharmacotherapy including at least one diuretic and a history of heart failure hospitalization within 12 months. The intervention group will receive a medication review at baseline followed by regular dose dispensing of the medication, counselling regarding medication use and symptoms of heart failure. The control patients are unknown to the pharmacy and receive usual care. The primary efficacy endpoint is medication adherence, pre-specified as a significant difference of the proportion of days covered between the intervention and control group within 365 days following randomization using pharmacy claims data for three CHF medications (angiotensin-converting enzyme inhibitors or angiotensin receptor blockers, beta-blockers, and mineralocorticoid receptor antagonists). The primary composite safety endpoint is days lost due to blindly adjudicated unplanned cardiovascular hospitalizations or death. Overall, 248 patients shall be randomized. The minimum follow-up is 12 months with an expected mean of 24 months. Based on the feasibility demonstrated in the pilot study, the randomized PHARM-CHF trial will test whether an interdisciplinary pharmacy-based intervention can safely improve medication adherence and will estimate the potential impact on clinical endpoints. ClinicalTrials.gov Identifier: NCT01692119. [ABSTRACT FROM AUTHOR]

Abstract: Objective: To study the effect of guava and synthetic vitamin C on the development of gingival inflammation during experimental gingivitis. Material and methods: Participants were randomly assigned to three groups supplemented daily with either 200 g guava, 200 mg synthetic vitamin C or water. The study included a 14 days pre‐experimental period with oral hygiene instructions, scaling, prophylaxis and supplementation. Thereafter, experiment gingivitis was initiated, while continuing supplementation. At baseline, Day 7 and Day 14 of experimental gingivitis, Plaque Index (PlI) and Gingival Index (GI) were assessed. During the entire study, dietary fruit/vegetables intake was minimal. Results: PlI increased in guava, vitamin C and control group (ΔPlI: 1.30, 1.61 and 1.79, respectively). However, the guava group developed significantly less plaque compared to the control group. The GI increase in both guava and vitamin C group was significantly less than the increase in the control group (ΔGI: 0.10, 0.24 and 0.87, respectively). Conclusion: In a population of young nonsmoking adults, consumption of either 200 g guava/day or 200 mg synthetic vitamin C/day, prior to and during the oral hygiene abstention period, has a preventive effect on the development of experimental gingivitis as compared to the control group that developed the usual amount of experimental gingivitis. [ABSTRACT FROM AUTHOR]

Aim: This pilot study investigated the use of acupuncture in the treatment of paediatric anxiety.Methods: Children with anxiety, aged 8-16, were randomised to either the acupuncture or waitlist control groups. Anxiety was measured using the Hamilton Anxiety Rating Scale (HAM-A) for children and adolescents with generalised anxiety disorder and Multidimensional Anxiety Scale for Children 2nd Edition (MASC-2) self-rated and parent-rated forms.Results: Twenty participants were enrolled in the study and 19 completed all the questionnaires to be included in the analysis. There were no differences in socio-demographic characteristics at baseline between the two groups. At the second assessment, the mean MASC-parent score for the acupuncture group was significantly lower than the waitlist group (65.6 (SD 15.0) compared to 81.0 (SD 11.9), P = 0.025) with an effect size = 1.13. The pre- and post-treatment comparisons were also significantly lower for both groups in the anxiety measures. In the acupuncture group, MASC-parent (P = 0.008, effect size 0.75) and the HAM-A (P < 0.001, effect size 1.4). In the waitlist group, MASC-self (P = 0.022; effect size 0.4), MASC-parent (P = 0.048; effect size 0.75) and HAM-A (P = 0.007; effect size 1.21).Conclusions: This study provided promising results on the potential use of acupuncture to treat children and adolescents with general anxiety. Future research using a randomised control trial with a sufficient sample size to control for confounders and sham (placebo) comparators is warranted. [ABSTRACT FROM AUTHOR]

Elevated levels of reactive oxygen species under diabetic condition lead to vascular complications and inflammation. This study aimed to examine the effects of hesperidin supplement on blood pressure and inflammatory markers in type 2 diabetes. In this research, 64 patients were randomly allocated to receive 500 mg/day hesperidin or placebo capsules for 6 weeks. Data on systolic blood pressure (SBP), diastolic blood pressure, serum total antioxidant capacity (TAC), tumor necrosis factor alpha, interleukin 6 (IL-6), and high-sensitivity C-reactive protein (hs-CRP) were collected at the baseline and at the end of the study. In the hesperidin group, SBP (122.7 ± 8.5 vs. 119.0 ± 7.4; p = .005), mean arterial blood pressure (94.2 ± 5.5 vs. 91.8 ± 5.5; p = .009), IL-6 (8.3 ± 2.1 vs. 7.4 ± 1.8; p = .001), and hs-CRP (1.9 ± 1.2 vs. 1.1 ± 0.9; p < .000) decreased whereas TAC increased (0.74 ± 0.1 vs. 0.82 ± 0.1; p < .000) in comparison to the baseline values. There was a significant difference in mean percent change of SBP, diastolic blood pressure, mean arterial blood pressure, serum TAC, and inflammatory markers (tumor necrosis factor alpha, IL-6, and hs-CRP) between hesperidin and control groups following intervention in adjusted models (p < .05). These results suggest that hesperidin may have antihypertensive and anti-inflammatory effects in type 2 diabetes. [ABSTRACT FROM AUTHOR]

At least 50% of infertile couple's problems are related to male factor infertility. This Randomized, Double-Blind, Placebo-Controlled Clinical Trial conducted in Urology unit of Infertility Clinic on 60 infertile men. Patients were randomly assigned to one of intervention and placebo (n = 30) groups. Finally, 28 subjects in each group completed the study. Participants in the intervention group took daily 80 mg curcumin nanomicelle and those in the placebo group took daily placebo for 10 weeks. Semen analysis, anthropometric, physical activity assessments, total antioxidant capacity, malondialdehyde, inflammatory factors, and reproductive hormones were measured at the baseline and at the end of the study. At the end of study, statistically significant differences were seen in the total sperm count, sperm concentration, and motility in the intervention group to the control group. In treatment group, the total sperm count, sperm concentration, and motility levels were also statistically increased at the end of study compared to the baseline values. Curcumin nanomicelle supplementation also resulted in a statistically significant improvement in plasma levels of total antioxidant capacity, malondialdehyde, C-reactive protein, and tumor necrosis factor a in comparison to the placebo. Medical therapy of asthenoteratospermia with curcumin nanomicelle supplement could improve quality of semen parameters. However, further investigation is suggested in this regard. [ABSTRACT FROM AUTHOR]

Background: Cachexia, described as weight loss (mainly in lean body mass [LBM]) and anorexia, is common in patients with advanced cancer. This study examined the efficacy and safety of anamorelin (ONO-7643), a novel selective ghrelin receptor agonist, in Japanese cancer patients with cachexia.Methods: This double-blind clinical trial (ONO-7643-04) enrolled 174 patients with unresectable stage III/IV non-small cell lung cancer (NSCLC) and cachexia in Japan. Patients were randomized to daily oral anamorelin (100 mg) or a placebo for 12 weeks. The primary endpoint was the change from the baseline LBM (measured with dual-energy x-ray absorptiometry) over 12 weeks. The secondary endpoints were changes in appetite, body weight, quality of life, handgrip strength (HGS), and 6-minute walk test (6MWT) results.Results: The least squares mean change (plus or minus the standard error) in LBM from the baseline over 12 weeks was 1.38 ± 0.18 and -0.17 ± 0.17 kg in the anamorelin and placebo groups, respectively (P < .0001). Changes from the baseline in LBM, body weight, and anorexia symptoms showed significant differences between the 2 treatment groups at all time points. Anamorelin increased prealbumin at weeks 3 and 9. No changes in HGS or 6MWT were detected between the groups. Twelve weeks' treatment with anamorelin was safe and well tolerated in NSCLC patients.Conclusions: Anamorelin significantly increased LBM and improved anorexia symptoms and the nutritional state, but not motor function, in Japanese patients with advanced NSCLC. Because no effective treatment for cancer cachexia is currently available, anamorelin can be a beneficial treatment option. Cancer 2018;124:606-16. © 2017 The Authors. Cancer published by Wiley Periodicals, Inc. on behalf of American Cancer Society. This is an open access article under the terms of the Creative Commons Attribution-NonCommercial-NoDerivs License, which permits use and distribution in any medium, provided the original work is properly cited, the use is non-commercial and no modifications or adaptations are made. [ABSTRACT FROM AUTHOR]

Objective: The ketones d-β-hydroxybutyrate (BHB) and acetoacetate are elevated during prolonged fasting or during a "ketogenic" diet. Although weight loss on a ketogenic diet may be associated with decreased appetite and altered gut hormone levels, it is unknown whether such changes are caused by elevated blood ketones. This study investigated the effects of an exogenous ketone ester (KE) on appetite.Methods: Following an overnight fast, subjects with normal weight (n = 15) consumed 1.9 kcal/kg of KE, or isocaloric dextrose (DEXT), in drinks matched for volume, taste, tonicity, and color. Blood samples were analyzed for BHB, glucose, insulin, ghrelin, glucagon-like peptide 1 (GLP-1), and peptide tyrosine tyrosine (PYY), and a three-measure visual analogue scale was used to measure hunger, fullness, and desire to eat.Results: KE consumption increased blood BHB levels from 0.2 to 3.3 mM after 60 minutes. DEXT consumption increased plasma glucose levels between 30 and 60 minutes. Postprandial plasma insulin, ghrelin, GLP-1, and PYY levels were significantly lower 2 to 4 hours after KE consumption, compared with DEXT consumption. Temporally related to the observed suppression of ghrelin, reported hunger and desire to eat were also significantly suppressed 1.5 hours after consumption of KE, compared with consumption of DEXT.Conclusions: Increased blood ketone levels may directly suppress appetite, as KE drinks lowered plasma ghrelin levels, perceived hunger, and desire to eat. [ABSTRACT FROM AUTHOR]

The relaxant effects of carvacrol, a phenolic monoterpene, on tracheal smooth muscle and its preventive effect on asthmatic animals were reported. The effect of carvacrol in asthmatic patients was examined in the placebo group (Group P, n = 11) receiving placebo and treatment group (Group C, n = 12), which received carvacrol capsule (1.2 mg/kg/day) for 2 months in a double-blind manner. Pulmonary function tests, respiratory symptoms, hematological indices, and high-sensitivity C-reactive protein (hs-CRP) were measured before, 1 and 2 months after starting treatment. At the end of treatment period, Pulmonary function tests values in Group C were significantly increased (p < .05 to p < .001). Most respiratory symptoms were also significantly reduced in Group C at the end of 2-month treatment (p < .05 to p < .001). Total and differential white blood cell (p < .05 to p < .001), as well as serum levels of hs-CRP in Group C were also significantly reduced after 2-month treatment with carvacrol (p < .001). Mean corpuscular hemoglobin concentration and hematocrit were changed in Group C (p < .05 and p < .01, respectively). However, in Group P, there was no significant changes in the evaluated parameters. Pulmonary function tests were increased but respiratory symptoms, inflammatory cells, and hs-CRP were reduced in asthmatic patients who received carvacrol that indicates its therapeutic effect on asthma. [ABSTRACT FROM AUTHOR]

While continuing care for substance use treatment has been associated with reduced involvement in the criminal justice system, much of this research lacks random assignment to continuing care and so is limited by self-selection bias. This study sought to determine the impact of adding telephone-based continuing care to intensive outpatient programs on criminal justice outcomes for people with cocaine dependence. In three continuing care studies, spanning 1998-2008, participants were randomly assigned to an intensive outpatient program or an intensive outpatient program plus a telephone-based continuing care intervention. Cocaine-dependent participants from these three studies were included in the analyses, with outcomes derived from a dataset of jurisdiction-wide criminal sentences from a state sentencing agency. Multiple logistic regression was employed to examine the odds of a criminal conviction occurring in the 4 years after enrollment in a continuing care study. The results showed that, controlling for a criminal sentence in the previous year, gender, age, and continuing care study, people with cocaine dependence randomized to an intensive outpatient program plus a telephone-based continuing care intervention had 54% lower odds (p = 0.05, odds ratio = 0.46, 95% CI: 0.20-1.02) of a criminal sentence in the 4 years after enrollment in the continuing care study, compared with those randomized to an intensive outpatient program alone. We can conclude that adding telephone monitoring and counseling to intensive outpatient programs is associated with fewer criminal convictions over a 4-year follow-up period compared with intensive outpatient programs alone. [ABSTRACT FROM AUTHOR]

Objective: The objective of this study was to test whether behavioral weight loss (BWL) intervention decreases headaches in women with comorbid migraine and overweight or obesity.Methods: This randomized, single-blind trial allocated women 18 to 50 years old with 4 to 20 migraine days per month and a BMI = 25.0-49.9 kg/m2 to 16 weeks of BWL (n = 54), which targeted exercise and eating behaviors for weight loss, or to migraine education control (ME, n = 56), which delivered didactic instruction on migraine and treatments. Participants completed a 4-week smartphone headache diary at baseline, posttreatment (16-20 wk), and follow-up (32-36 wk). The primary outcome was posttreatment change in migraine days per month, analyzed via linear mixed effects models.Results: Of 110 participants randomly assigned, 85 (78%) and 80 (73%) completed posttreatment and follow-up. Although the BWL group achieved greater weight loss (mean [95% CI] in kilograms) than the ME group at posttreatment (-3.8 [-2.5 to -5.0] vs. + 0.9 [-0.4 to 2.2], P < 0.001) and follow-up (-3.2 [-2.0 to -4.5] vs. + 1.1 [-0.2 to 2.4], P < 0.001), there were no significant group (BWL vs. ME) differences (mean [95% CI]) in migraine days per month at posttreatment (-3.0 [-2.0 to -4.0] vs. -4.0 [-2.9 to -5.0], P = 0.185) or follow-up (-3.8 [-2.7 to -4.8] vs. -4.4 [-3.4 to -5.5], P = 0.378).Conclusions: Contrary to hypotheses, BWL and ME yielded similar, sustained reductions in migraine headaches. Future research should evaluate whether adding BWL to standard pharmacological and/or nonpharmacological migraine treatment approaches yields greater benefits. [ABSTRACT FROM AUTHOR]

Objective: The present investigation was intended to test the hypothesis that the elderly provided with the frequent consumption of fishes marinated in essential oil of Perilla frutescens (EOPF) or not would experience fewer depressive symptoms after 6 months.Methods: A total of 180 participants were recruited from Sina Hospital, Mashhad, Iran, who were diagnosed with depression based on Diagnostic and Statistical Manual of Mental Disorders, 4th edition, Text Revision and Beck Depression Inventory. Participants (n = 180) were randomly assigned in a 1:1:1 ratio to Groups A, B, and C. The last two were provided with an instruction to consume Caspian white fish marinated in the presence or absence of EOPF (434 g each week or four meals per week). Group A served as the control with the common diet. The outcome measures were performed using the Beck Depression Inventory and the General Health Questionnaire.Results: There were no statistically significant differences in depressive symptom scores between groups with frequent fish consumption as compared with the control (p > 0.05). Yet adjustment for covariates showed that there was a significant reduction in depression among them (p < 0.05). Moreover, consumption of fish and EOPF was associated with more considerable improvements than Groups A and B (p < 0.05).Conclusions: It could be concluded that high intakes of unsaturated fatty acids can afford to diminish likelihood of late-life depression. Copyright © 2017 John Wiley & Sons, Ltd. [ABSTRACT FROM AUTHOR]

Objective: Most investigations of pharmacotherapy for treating Alzheimer's disease focus on patients with mild-to-moderate symptoms, with little evidence to guide clinical decisions when symptoms become severe. We examined whether continuing donepezil, or commencing memantine, is cost-effective for community-dwelling, moderate-to-severe Alzheimer's disease patients.Methods: Cost-effectiveness analysis was based on a 52-week, multicentre, double-blind, placebo-controlled, factorial clinical trial. A total of 295 community-dwelling patients with moderate/severe Alzheimer's disease, already treated with donepezil, were randomised to: (i) continue donepezil; (ii) discontinue donepezil; (iii) discontinue donepezil and start memantine; or (iv) continue donepezil and start memantine.Results: Continuing donepezil for 52 weeks was more cost-effective than discontinuation, considering cognition, activities of daily living and health-related quality of life. Starting memantine was more cost-effective than donepezil discontinuation. Donepezil-memantine combined is not more cost-effective than donepezil alone.Conclusions: Robust evidence is now available to inform clinical decisions and commissioning strategies so as to improve patients' lives whilst making efficient use of available resources. Clinical guidelines for treating moderate/severe Alzheimer's disease, such as those issued by NICE in England and Wales, should be revisited. © 2016 The Authors. International Journal of Geriatric Psychiatry published by John Wiley & Sons Ltd. [ABSTRACT FROM AUTHOR]

Background: Local anesthesia for lipoma excision can be feasible with anesthetic injection in the fascial plane between the lipoma and the surrounding soft tissues under real-time ultrasonography [ultrasound- guided lipoma plane (ULP) block]. The advantage of targeting a single anesthetic injection plane under ultrasound guidance may allow for technically easier block placement and long-term analgesic effects.Methods: Forty-eight patients were randomly assigned to receive ULP block, group A (n = 24) or traditional block, group B (n = 24). Primary outcome measure was the number of needle passes required to perform the blockade. The level of procedure pain and the time to first request of analgesia were assessed.Results: Median (interquartile range) needle passes required to complete the blockade was significantly less in the group A 1(1, 1) in comparison with the group B 3 (2.5, 3); P = 0.0001. Group A required fewer needle redirections 1.5 (1, 2) than group B 2 (2, 2.5); P = 0.001. Group A showed significantly less procedure-related pain 2 (2, 3) when compared with group B 4 (3, 4); P = 0.0001. The time to first rescue analgesic was significantly longer in group A (21.3 ± 4.7 h) in comparison with group B (4.4 ± 1.2 h); P = 0.001.Conclusion: Ultrasound-guided lipoma plane blockade reduces the number of needle passes required to complete the block and provides less procedure pain and longer pain relief compared with the traditional block in patients undergoing lipoma excision. [ABSTRACT FROM AUTHOR]

Two studies showed an improvement in clinical outcomes after alcohol approach bias retraining, a form of Cognitive Bias Modification (CBM). We investigated whether transcranial direct current stimulation (tDCS) could enhance effects of CBM. TDCS is a neuromodulation technique that can increase neuroplasticity and has previously been found to reduce craving. One hundred alcohol-dependent inpatients (91 used for analysis) were randomized into three experimental groups in a double-blind parallel design. The experimental group received four sessions of CBM while receiving 2 mA of anodal tDCS over the dorsolateral prefrontal cortex (DLPFC). There were two control groups: One received sham stimulation during training and one received active stimulation at a different moment. Treatment outcomes were abstinence duration (primary) and relapse after 3 and 12 months, craving and approach bias (secondary). Craving and approach bias scores decreased over time; there were no significant interactions with experimental condition. There was no effect on abstinence duration after three months (χ2(2) = 3.53, p = 0.77). However, a logistic regression on relapse rates after one year (standard outcome in the clinic, but not-preregistered) showed a trend when relevant predictors were included; relapse was lower in the condition receiving active stimulation during CBM only when comparing to sham stimulation (B = 1.52, S.E. = .836, p = .07, without predictors: p = .19). No strong evidence for a specific enhancement effect of tDCS on CBM was found. However, in a post-hoc analysis, tDCS combined with CBM showed a promising trend on treatment outcome. Important limitations are discussed, and replication is necessary to find more reliable effects. [ABSTRACT FROM AUTHOR]

This study aimed to examine the effects of hesperidin supplement on the glycemic parameters, oxidative DNA damage, and lipid peroxidation in patients with type 2 diabetes. Sixty-four patients were randomly allocated to receive 500 mg/day hesperidin or placebo capsules for 6 weeks. Data on glycemic parameters, total antioxidant capacity (TAC), 8-hydroxydeoxyguanosine (8-OHDG), and malondialdehyde (MDA) were collected at the baseline and at the end of the study. In hesperidin group, TAC increased (0.74 ± 0.16 vs. 0.82 ± 0.18), while serum froctoseamin (5.79 ± 5.86 vs. 5.01 ± 4.95; p = 0.001), 8-OHDG (14.32 ± 6.4 vs. 11.00 ± 7.0; p = 0.000), and MDA (5.78 ± 1.76 vs. 4.60 ± 0.75; p = 0.000) decreased in comparison with the baseline values. There was a significant difference in percent change of TAC (13.35 ± 19.21 vs. 3.13 ± 10.02; p = 0.043), froctoseamin (-10.10 ± 16.84 vs. 4.27 ± 34.646), 8-OHDG (-25.11 ± 28.23 vs. 8.69 ± 35.41; p = 0.000), and MDA (-16.46 ± 18.04 vs. -1.82 ± 22.63; p = 0.007) between hesperidin and control groups following intervention in adjusted models. These results suggest that hesperidin may improve TAC and alleviate serum froctoseamin, 8-OHDG, and MDA levels in type 2 diabetes. Copyright © 2017 John Wiley & Sons, Ltd. [ABSTRACT FROM AUTHOR]

Objectives: The main objectives of this pragmatic randomized controlled trial were to investigate the impact of cognitive behaviour therapy (CBT) and an active social control (befriending) on depression and anxiety symptoms in people with chronic obstructive pulmonary disease (COPD).Methods: Eligible participants were randomly allocated to receive eight weekly telephone interventions of CBT (n = 54) or befriending (n = 56). Repeated-measures ANOVA was used to assess changes in scores and Cohen's d was used to assess effect sizes.Results: Significant improvement was observed in anxiety symptoms for the befriending group from baseline (T1) to post-intervention assessment (T2) and to 8-week follow-up assessment (T3), with a small to medium effect size (Cohen's d = 0.3). Significant improvement was noted in depression symptoms from T1 to T2 for both groups, but only the CBT group had a significant difference at T3, with a small to medium effect size (Cohen's d = 0.4). For secondary outcomes, there was a significant change in COPD symptoms from T1 to T2 for the befriending group; however, at T3 this change was no longer significant. Finally, there was a significant change in general self-efficacy for both groups between T1 and T2, and T1 and T3.Conclusion: Cognitive behaviour therapy reduced depression symptoms but not anxiety. Befriending reduced depression symptoms in the short term and anxiety symptoms in both the short term and long term. Further research is needed to demonstrate non-inferiority of telephone delivery compared with other formats, and to understand the impact of befriending which has the potential to be a cost-effective support for people with COPD. Statement of contribution What is already known on this subject? Depression and anxiety are common comorbidities in people with chronic obstructive pulmonary disease. Mood disorders are not commonly routinely treated in people with chronic obstructive pulmonary disease. Telephone-administered CBT has been shown to be as effective as face-to-face CBT in reducing depression and anxiety. What does this study add? Telephone-administered CBT can reduce depression symptoms in people with COPD. Telephone-administered befriending can reduce anxiety and depression symptoms in people with COPD. People with COPD who have mood disorders would prefer to have CBT than befriending. [ABSTRACT FROM AUTHOR]

Background and Purpose: Our initial aim was to generate cannabinoid agents that control spasticity, occurring as a consequence of multiple sclerosis (MS), whilst avoiding the sedative side effects associated with cannabis. VSN16R was synthesized as an anandamide (endocannabinoid) analogue in an anti-metabolite approach to identify drugs that target spasticity.Experimental Approach: Following the initial chemistry, a variety of biochemical, pharmacological and electrophysiological approaches, using isolated cells, tissue-based assays and in vivo animal models, were used to demonstrate the activity, efficacy, pharmacokinetics and mechanism of action of VSN16R. Toxicological and safety studies were performed in animals and humans.Key Results: VSN16R had nanomolar activity in tissue-based, functional assays and dose-dependently inhibited spasticity in a mouse experimental encephalomyelitis model of MS. This effect occurred with over 1000-fold therapeutic window, without affecting normal muscle tone. Efficacy was achieved at plasma levels that are feasible and safe in humans. VSN16R did not bind to known CB1 /CB2 /GPPR55 cannabinoid-related receptors in receptor-based assays but acted on a vascular cannabinoid target. This was identified as the major neuronal form of the big conductance, calcium-activated potassium (BKCa ) channel. Drug-induced opening of neuronal BKCa channels induced membrane hyperpolarization, limiting excessive neural-excitability and controlling spasticity.Conclusions and Implications: We identified the neuronal form of the BKCa channel as the target for VSN16R and demonstrated that its activation alleviates neuronal excitability and spasticity in an experimental model of MS, revealing a novel mechanism to control spasticity. VSN16R is a potential, safe and selective ligand for controlling neural hyper-excitability in spasticity. [ABSTRACT FROM AUTHOR]

The purpose of this study was to measure alterations in sensorimotor skills and balance resulting from slackline training and conventional balance training. Forty-three physically fit subjects were randomized into three groups. Two groups practiced three times a week for 15 minutes, including at least once supervised session, on the slackline or perform conventional balance training for 6 weeks. The control group was not allowed to perform any balance training. Before and after the intervention, the subjects underwent sensorimotor and strength tests. The results of our intra-class correlation analysis showed that the stability parameters from the multifunctional training device (MFT, 0.7), the height during the countermovement jump (CMJ, 0.95) and the maximum force (0.88) during leg press showed excellent reliability. A post hoc comparison indicated a larger effect of conventional training (almost 11% reduction in MFT stability) compared with slackline training in group-wide comparisons of the pre- to the post-training measurements. The factor analysis showed that stability and sensorimotor assessment using MFT were correlated, as were height during CMJ and maximal force during leg press, which represented dynamic strength. Because CMJ had the highest intra-class correlation value, it was chosen over maximum force from leg press. For these reasons, only two out of nine measured parameters, namely MFT stability and CMJ, were analysed across groups. The only observed difference between the two groups was MFT stability (slackline - 1.5%, conventional - 13%), whereas the improvement of CMJ was the same (slackline + 3%, conventional + 3%). It can be concluded that slacklining is partly complementary to conventional sensorimotor training. [ABSTRACT FROM AUTHOR]

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Background: The ICON6 trial showed that cediranib, an oral inhibitor of vascular endothelial growth factor receptors 1, 2, and 3, improved clinical outcomes for patients with platinum-sensitive relapsed ovarian cancer when it was used with chemotherapy and was continued as maintenance therapy. This study describes health-related quality of life (QOL) during the first year of treatment.Methods: Four hundred fifty-six women were randomly allocated to receive standard chemotherapy only, chemotherapy with concurrent cediranib, or chemotherapy with cediranib administered concurrently and continued as maintenance. Patients completed QOL questionnaires until disease progression every 3 weeks during chemotherapy and then every 6 weeks to 1 year. Patients alive with disease progression completed a QOL form 1 year after randomization. The primary QOL endpoint was the global score from the Quality of Life Questionnaire Core 30 (of the European Organization for Research and Treatment of Cancer) at 1 year, with the standard chemotherapy group compared with the concurrent-maintenance cediranib group.Results: The rate of questionnaire compliance was 90% at the baseline and 76% at 1 year and was similar across the 3 groups. The mean global QOL score at 1 year was 62.6 points for the standard chemotherapy group and 68.7 points for the concurrent-maintenance group (+4.5; 95% confidence interval, -2.0 to 11.0; P = .18). Sensitivity analyses suggested that this finding was robust to the effect of missing data, and the improvement became statistically significant after adjustments for self-reported diarrhea.Conclusions: The 6th study by the International Collaboration in Ovarian Neoplasm (ICON6) showed a significant improvement in progression-free survival with cediranib as concurrent and maintenance therapy. No QOL detriment with cediranib was found 1 year after treatment was commenced. The maintenance of QOL along with prolonged cancer control suggests that cediranib has a valuable role in the treatment of relapsed ovarian cancer. Cancer 2017;123:2752-61. © 2017 The Authors. Cancer published by Wiley Periodicals, Inc. on behalf of American Cancer Society. This is an open access article under the terms of the Creative Commons Attribution License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited. [ABSTRACT FROM AUTHOR]

Background: To examine whether SMOFlipid prevents progression of intestinal failure-associated liver disease (IFALD) in parenteral nutrition (PN)-dependent infants with early IFALD (conjugated bilirubin 17-50 µmol/L, 1-3 mg/dL).Study Design: Pilot multicenter blinded randomized controlled trial comparing SMOFlipid with Intralipid. Patients received the trial lipid for up to 12 weeks, unless they achieved full enteral tolerance sooner. The primary clinical outcome was the serum conjugated bilirubin.Results: Twenty-four infants (mean age, 6 weeks) participated in the trial (13 Intralipid and 11 SMOFlipid). At the time of trial enrollment, patients in both groups were receiving 90% of their calories by PN. Mean duration on trial was 8 weeks and did not differ according to treatment ( P = .99). At trial conclusion, patients who received SMOFlipid had a lower conjugated bilirubin than those who received Intralipid (mean difference, -59 µmol/L; P = .03). Patients receiving SMOFlipid were also more likely to have a decrease in serum conjugated bilirubin to 0 µmol/L than those in the Intralipid group over the entire observation period (hazard ratio, 10.6; 95%; P = .03). The time to achievement of full enteral tolerance did not differ statistically (hazard ratio, 1.3; P = .59) between the groups. There was no significant difference in safety outcomes between the groups.Conclusions: Compared with Intralipid, SMOFlipid reduces the risk of progressive IFALD in children with intestinal failure. This trial was registered at clinicaltrials.gov as NCT00793195. [ABSTRACT FROM AUTHOR]

Aim: Optimal duration of parenteral antibiotics for treating neonatal sepsis ranges from 7-14 days. We compared the efficacy of 7 versus 10 days duration of intravenous antibiotics for neonatal septicaemia.Methods: We randomised blood culture-proven septic neonates (≥32 weeks and birth weight ≥1.5 kg) to receive either 7 or 10 days duration of intravenous antibiotics. We followed up neonates upto 28 days after stopping antibiotics for treatment failure defined by reappearance of clinical sepsis with a blood culture growing the same organism as cultured earlier, or in the absence of a positive culture, the presence of C-reactive protein and as adjudicated by an expert committee.Results: A total of 132 neonates were randomised to receive either 7 (n = 66) or 10 (n = 66) days duration of antibiotic therapy. Out of 128 neonates (64 per group) followed up, two (one per group) were regarded as 'treatment failure', and two were labelled as fresh episodes of sepsis (both in 10-day group). The risk (95% confidence interval) for treatment failure in the 7-day group was (1.0 (0.064-15.644) was not significantly higher. Neonates in both groups had comparable need for oxygen, inotropic support and blood products, duration of oxygen therapy and time to attainment of full feeds. The duration of hospitalisation was significantly longer in the 10-day group.Conclusion: A 7-day course of intravenous antibiotics may be sufficient to treat neonatal sepsis with the advantage of shorter hospital stay, but a larger meta-analysis would be required to state this with a degree of certainty. [ABSTRACT FROM AUTHOR]

Objective: To assess the short-term tolerability of lorcaserin alone or with two dose regimens of phentermine.Methods: This was a 12-week, randomized, double-blind, pilot safety study of N = 238 nondiabetic patients with obesity or overweight with ≥1 comorbidity randomized to lorcaserin 10 mg twice daily (BID; LOR BID) alone or with phentermine 15 mg once daily (QD; LOR BID+PHEN QD) or 15 mg twice daily (LOR BID+PHEN BID). Patients reporting ≥ 1 of 9 potentially serotonergic adverse events (AEs), mean weight loss (WL), and ≥5% WL are reported.Results: N = 238 were randomized, and N = 235 were treated. N = 94 reported potentially serotonergic AEs: 37.2% LOR BID, 42.3% LOR BID+PHEN QD, and 40.5% LOR BID+PHEN BID. AEs leading to discontinuation were reported approximately twice as often in the LOR BID+PHEN BID group versus the LOR BID group. Mean WL was 3.5 kg/3.3%, 7.0 kg/6.7%, and 7.6 kg/7.2% for LOR BID, LOR BID+PHEN QD, and LOR BID+PHEN BID, respectively. At least 5% WL was achieved by 28.2% LOR BID, 59.0% LOR BID+PHEN QD (P = 0.0002 vs. LOR BID), and 70.9% LOR BID+PHEN BID (P < 0.0001 vs. LOR BID) patients.Conclusions: Phentermine added to lorcaserin enhanced short-term weight loss but did not increase incidence of potentially serotonergic AEs; however, phentermine twice daily increased discontinuation compared to both lorcaserin alone and lorcaserin plus phentermine once daily. [ABSTRACT FROM AUTHOR]

Background: Despite the prophylactic use of platelet transfusion, hemorrhagic complications still represent an important cause of morbidity and mortality in patients with hematologic malignancies. Patient-related factors and characteristics of the transfused product can affect transfusion efficacy.Study Design and Methods: The aim of this study was to develop and validate the Platelet Efficacy Score (PEscore), based on patient and product characteristics, to predict the likelihood of a satisfactory platelet transfusion (absolute increment ≥10.5 × 109 /L). This study utilized data relative to 16,265 platelet transfusions performed in 1592 oncohematologic patients. The whole sample was divided into two random samples: a training set, in which different patient-related and transfusion-related characteristics were included in a predictive model to develop the PEscore; and a validation set, in which the predictive properties of the PEscore were confirmed. In the training set, multilevel logistic regression analysis was performed in which the likelihood of attaining a satisfactory transfusion was modeled.Results: The predictive score ranged between 0 and 30. Predictive properties of the PEscore were confirmed by the observed rates of satisfactory transfusions in the validation sample; the probability of a satisfactory transfusion was less than 10% for a score less than 12 and exceeded 50% if the score was 22 or higher. The likelihood of a satisfactory transfusion increased by 29% for a 1-unit increase in the PEscore (odds ratio, 1.29; 95% confidence interval, 1.27-1.31).Conclusion: The availability of a prediction score can increase transfusion efficacy, help the transfusion medicine specialist in the choice of the best product for the individual patient, and avoid waste of resources. [ABSTRACT FROM AUTHOR]

Objective: In-person lifestyle interventions for obesity treatment yield significant improvements in depression. These improvements may be attributed to the excellent weight losses produced by in-person interventions. In contrast, Internet programs yield more modest weight losses, and their effect on depression is unknown. This study is the first to examine whether Internet-delivered obesity treatment impacts depressive symptoms.Methods: Participants (N = 136) were randomized to either a community campaign plus Internet behavioral weight loss (IBWL) or community campaign alone (Control). IBWL did not include online social support components. A measure of depressive symptoms was administered, and weight was objectively assessed.Results: Of the total sample, 24% met the clinical cutoff for elevated depression risk at baseline. IBWL participants lost more weight during treatment (P = 0.005) and experienced significantly greater improvements in depressive symptoms (P = 0.02). Among participants who met the clinical cutoff for elevated risk for depression at baseline, those assigned to IBWL had greater improvements in depressive symptoms during treatment compared to Control (P = 0.033). Consequently, at post-treatment, a smaller percentage of IBWL participants were at elevated risk for depression.Conclusions: This study is the first to show that Internet-delivered obesity treatment improves depression risk and depressive symptoms in individuals with overweight or obesity. [ABSTRACT FROM AUTHOR]

Objective: To determine the effect of prebiotic supplementation on metabolic endotoxemia and systemic inflammation in adults with overweight and obesity.Methods: Samples from a previously conducted randomized, double-blind, placebo-controlled trial were used for analysis. Participants were randomized to 21 g of oligofructose (n = 20; BMI 30.4 kg/m2 ) or a maltodextrin placebo (n = 17; BMI 29.5 kg/m2 ) for 12 weeks. A total of 37 participants had samples available for the current analysis. Resistin, adiponectin, plasminogen activator inhibitor-1 (PAI-1), interleukin-6 (IL-6), tumor necrosis factor-α (TNF-α), and macrophage chemoattractant protein-1 (MCP-1) were quantified using MILLIPLEX® assays. Lipopolysaccharide (LPS) was measured using PyroGene™ Recombinant Factor C Assay.Results: Plasma LPS concentrations were reduced by 40% in the oligofructose group over 12 weeks compared to a 48% increase in the placebo group (P = 0.04). PAI-1, a risk factor for thrombosis, was reduced to a greater extent in the oligofructose group (-17.3 ± 2.6 ng/ml) compared to the placebo group (-9.7 ± 1.8 ng/ml; P = 0.03). Oligofructose did not affect IL-6, TNF-α, MCP-1, adiponectin, or resistin.Conclusions: Oligofructose reduces metabolic endotoxemia and PAI-1. Incorporating prebiotics into the diet through supplements or functional foods may help mitigate some markers of obesity-associated inflammation. [ABSTRACT FROM AUTHOR]

Objective: The aim of the study was to assess whether in geriatric patients, the shear bond strength (SBS) of glass-ceramics differed when compared to young controls.Background: In the need of aesthetic restorations for geriatric patients, reliable bonding of glass-ceramics should be accomplished; however, glass-ceramics bonding on aged tooth structures is still unclear.Materials and Methods: Sixty extracted molars from young and geriatric patients [18-25 (Y), and 65-80 (O)] were cut buccolingually to prepare enamel (E) and dentin (D) surfaces. Both surfaces were randomly divided into three groups according to the resin cements: Variolink II (V); Superbond (S); and Clearfil Esthetic Cement (C) (n = 10). Disc-shaped glass-ceramics (IPS E-max Press) (n = 120) were prepared. Specimens were bonded and subjected to thermocycling. SBS test was performed using a universal testing machine (0.5 mm/min). After debonding, the surfaces were examined using stereomicroscope and scanning electron microscope. Data were statistically analysed with Kolmogorov-Smirnov, Levene, anova and Bonferroni tests (p = 0.05).Results: There were no significant differences between the old and young teeth surfaces. V showed the highest SBS [MPa(SD)] on both enamel and dentin [36.7 (6.5) (YE), 23.2 (13.2) (YD), 32.1 (16.2) (OE), 25.5 (8.6) (OD), respectively]. Significant differences were observed between resin cements (p < 0.05). The failure types were 43% adhesive between tooth and cement, 48% mix, 9% adhesive between cement and ceramic, regardless of cement type.Conclusion: In geriatric patients, the shear bond strength of glass-ceramics did not differ when compared to that of young controls. On the dentin surface, etch-rinse resin cements appear to be more appropriate for glass-ceramics bonding. [ABSTRACT FROM AUTHOR]

Objective: To evaluate maternal and perinatal outcomes after induction of labour versus expectant management in pregnant women with gestational diabetes at term.Design: Multicentre open-label randomised controlled trial.Setting: Eight teaching hospitals in Italy, Slovenia, and Israel.Sample: Singleton pregnancy, diagnosed with gestational diabetes by the International Association of Diabetes and Pregnancy Study Groups criteria (IADPSGC), between 38+0 and 39+0 weeks of gestation, without other maternal or fetal conditions.Methods: Patients were randomly assigned to induction of labour or expectant management and intensive follow-up. Data were analysed by 'intention to treat'.Main Outcome Measures: The primary outcome was incidence of caesarean section. Secondary outcomes were maternal and perinatal mortality and morbidity.Results: A total of 425 women were randomised to the study groups. The incidence of caesarean section was 12.6% in the induction group versus 11.7% in the expectant group. No difference was found between the two groups (relative risk, RR 1.06; 95% confidence interval, 95% CI 0.64-1.77; P = 0.81). The incidence of non-spontaneous delivery, either by caesarean section or by operative vaginal delivery, was 21.0 and 22.3%, respectively (RR 0.94; 95% CI 0.66-1.36; P = 0.76). Neither maternal nor fetal deaths occurred. The few cases of shoulder dystocia were solved without any significant birth trauma.Conclusions: In women with gestational diabetes, without other maternal or fetal conditions, no difference was detected in birth outcomes regardless of the approach used (i.e. active versus expectant management). Although the study was underpowered, the magnitude of the between-group difference was very small and without clinical relevance.Tweetable Abstract: Immediate delivery or expectant management in gestational diabetes at term? [ABSTRACT FROM AUTHOR]

Objective: To evaluate the effect of pelvic floor muscle exercises (PFME) for postpartum anal incontinence (AI).Design: A parallel two-armed randomised controlled trial stratified on obstetrical anal sphincter injury with primary sphincter repair and hospital affinity.Setting: Ano-rectal specialist out-patient clinics at two hospitals in Norway.Population: One hundred and nine postpartum women with AI at baseline.Methods: The intervention group received 6 months of individual physiotherapy-led PFME and the control group written information on PFME. Changes in St. Mark's scores and predictors of post-intervention AI were assessed by independent samples t-tests and multiple linear regression analyses, respectively. The study was not blind.Main Outcome Measures: The primary outcome measure was change in AI symptoms on the St. Mark's score from baseline to post-intervention. Secondary outcome measures were manometry measures of anal sphincter length and strength, endoanal ultrasound (EAUS) defect score and voluntary pelvic floor muscle contraction.Results: There was a significant difference in the reduction of St. Mark's scores from baseline to post-intervention in favour of the PFME group (-2.1 versus -0.8 points, P = 0.040). No differences in secondary outcome measures were found between groups. Baseline St. Mark's, PFME group affinity and EAUS defect score predicted post-intervention St. Mark's score in the imputed intention-to-treat analyses. The analysis on un-imputed data showed that women performing weekly PFME improved their AI scores more than women in the control group did.Conclusions: Our results indicate that individually adapted PFME reduces postpartum AI symptoms.Tweetable Abstract: Performing regular pelvic floor muscle exercises may be an effective treatment for postpartum anal incontinence. [ABSTRACT FROM AUTHOR]

The aim of this study was to investigate the impact of resveratrol supplementation along with non-surgical periodontal treatment on blood glucose, insulin, insulin resistance, triglyceride (TG), and periodontal markers in patients with type 2 diabetes with periodontal disease. In this double-blind clinical trial study, 43 patients with diabetes with chronic periodontitis were participated. Subjects were randomly allocated to intervention and control groups. The intervention and control groups received either 480 mg/day of resveratrol or placebo capsules (two pills) for 4 weeks. Fasting blood glucose, insulin, insulin resistance (homeostasis model assessment of insulin resistance), TGs, and pocket depth were measured in all subjects' pre-intervention and post-intervention. The mean serum levels of fasting insulin and insulin resistance (homeostasis model assessment of insulin resistance) were significantly lower in the intervention group compared with control group (10.42 ± 0.28 and 10.92 ± 0.9; 3.66 ± 0.97 and 4.49 ± 1.56, respectively). There was a significant difference in the mean pocket depth between intervention and control groups (2.35 ± 0.6 and 3.38 ± 0.5, respectively) following intervention. No significant differences were observed in the mean levels of fasting blood glucose and TGs between two groups' post-intervention. It is recommended that resveratrol supplementation may be beneficial as adjuvant therapy along with non-surgical periodontal treatment in insulin resistance and improving periodontal status among patients with diabetes with periodontal disease. Copyright © 2016 John Wiley & Sons, Ltd. [ABSTRACT FROM AUTHOR]

Aim: Adolescents with intellectual disability experience poorer heath than their peers in the general population, partially due to communication barriers and knowledge gaps in their health history. This study aimed to test a health intervention package against usual care for a range of health promotion and disease detection outcomes.Method: A parallel-group cluster randomized controlled trial was conducted with Australian adolescents with intellectual disability living in the community. Randomization occurred at school level. The intervention package consisted of classroom-based health education, a hand-held personalized health record, and a health check. Evidence of health promotion, disease prevention, and case-finding activities were extracted from general practitioners' records for 12 months post-intervention.Results: Clinical data was available for 435 of 592 (73.5%) participants from 85 schools. Adolescents allocated to receive the health intervention were more likely to have their vision (odds ratio [OR] 3.3; 95% confidence interval [CI] 1.8-6.1) and hearing (OR 2.7; 95% CI 1.0-7.3) tested, their blood pressure checked (OR 2.4; 95% CI 1.6-3.7), and weight recorded (OR 4.8; 95% CI 3.1-7.6). There was no difference between health intervention and usual care for identification of new diseases.Interpretation: The school-based intervention package increased healthcare activity in adolescents with intellectual disability living in the community. [ABSTRACT FROM AUTHOR]

Objectives: The prevalence of neuropsychiatric symptoms in cognitively impaired nursing home residents is known to be very high, with depression and agitation being the most common symptoms. The possible effects of a 12-week intervention with animal-assisted activities (AAA) in nursing homes were studied. The primary outcomes related to depression, agitation and quality of life (QoL).Method: A prospective, cluster randomized multicentre trial with a follow-up measurement 3 months after end of intervention was used. Inclusion criteria were men and women aged 65 years or older, with a diagnosis of dementia or having a cognitive deficit. Ten nursing homes were randomized to either AAA with a dog or a control group with treatment as usual. In total, 58 participants were recruited: 28 in the intervention group and 30 in the control group. The intervention consisted of a 30-min session with AAA twice weekly for 12 weeks in groups of three to six participants, led by a qualified dog handler. Norwegian versions of the Cornell Scale for Depression, the Brief Agitation Rating Scale and the Quality of Life in Late-stage Dementia scale were used.Results: A significant effect on depression and QoL was found for participants with severe dementia at follow-up. For QoL, a significant effect of AAA was also found immediately after the intervention. No effects on agitation were found.Conclusions: Animal-assisted activities may have a positive effect on symptoms of depression and QoL in older people with dementia, especially those in a late stage. Copyright © 2016 John Wiley & Sons, Ltd. [ABSTRACT FROM AUTHOR]

Background: An antiplaque agent with minimal side effects that can be used as an effective adjunct to mechanical plaque control is needed. The current study is designed to evaluate efficacy of triphala (TRP) mouthwash in reduction of plaque and gingivitis.Methods: Ninety individuals with chronic generalized gingivitis were randomly assigned to three groups: 1) group I, placebo mouthwash; 2) group II, TRP mouthwash; and 3) group III, chlorhexidine (CHX) mouthwash. All individuals were instructed to rinse with their respective mouthwash twice daily. 1) Plaque index (PI); 2) gingival index (GI); 3) oral hygiene index-simplified (OHI-S); and 4) microbiologic colony counts were recorded at baseline and at 7, 30, and 60 days.Results: All three groups showed gradual reduction in PI, GI, and OHI-S levels from baseline to 7, 30, and 60 days. There was also significant reduction in microbial counts in all groups at all time intervals except in group I. A significant difference was noticed with respect to reduction in PI, GI, OHI-S, and microbiologic counts in group I compared with groups II and III. However, no significant differences were found between groups II and III for any parameters at any time intervals.Conclusions: TRP mouthwash was found to decrease inflammatory parameters from baseline to follow-up intervals. Because improvement in gingivitis was comparable with that of CHX mouthwash, TRP mouthwash can be considered a potential therapeutic agent in the treatment of gingivitis. [ABSTRACT FROM AUTHOR]

Background: Minocycline microspheres (MMs) are being used to treat residual inflamed periodontal pockets during periodontal maintenance therapy (PMT), but evidence for efficacy from randomized clinical trials is lacking. The purpose of this study is to evaluate the effect of MMs plus scaling and root planing (SRP) on these sites.Methods: Sixty patients with chronic periodontitis on 6-month PMT intervals to be followed for 1 year were randomized (51 completed the study) into two statistically similar groups, SRP + MM (aged 66.8 years) and SRP alone (aged 67 years), to treat a ≥5 mm posterior interproximal pocket during PMT with a history of bleeding on probing (BOP). Group treatments were applied to the site at baseline and 6 months. Clinical attachment levels (CALs; primary outcome), probing depths (PDs), plaque, and BOP also were recorded at baseline and 6 and 12 months. In addition, gingival crevicular fluid was analyzed for an inflammation index ratio of interleukin (IL)-1β/IL-1 receptor antagonist (ra) using enzyme-linked immunosorbent assays.Results: All clinical parameters improved significantly (P <0.005) from baseline in both groups with no differences between groups at any time point. CAL decreased 17% (0.9 ± 0.8 mm) and 13% (0.7 ± 0.9 mm) in SRP + MM and 11% (0.7 ± 1.1 mm) and 21% (1.2 ± 0.9 mm) in SRP at 6 and 12 months, respectively. The odds of having BOP decreased 90% (down to 38% of patients) and 95% (26%) in SRP + MM and 82% (42%) and 82% (41%) in SRP at 6 and 12 months, respectively. IL-1β/IL-1ra decreased a significant 61% (P = 0.009) only in SRP + MM at 6 months.Conclusions: SRP of inflamed moderate pockets during 6-month PMT, with or without MMs, improves CALs, along with PDs and BOP over a 1-year period. The use of MMs did not result in an additional benefit over SRP alone. [ABSTRACT FROM AUTHOR]