A randomised clinical trial comparing outcomes of a single digit volar plate injury - Buddy loops versus dorsal thermoplastic orthosis in a neutral position: study protocol.

BACKGROUND: Volar plate injuries are a common hand injury and complications associated with this injury such as a fixed flexion deformity, persistent pain and oedema can have a significant impact on a person's function. The literature reports these injuries are treated using various splinting materials such as thermoplastic, in varying degrees of proximal interphalangeal joint flexion or buddy loops. Despite volar plate injuries being reported as common, optimal non-surgical treatment of these injuries remains unclear. This study aims to investigate whether a dorsal blocking orthosis in a neutral position (00) is more effective than buddy loops for a volar plate injury to the proximal interphalangeal joint in preventing a fixed flexion deformity, reducing pain, managing oedema, and promoting function. METHODS: This study is a single-centre, prospective parallel-group, single blinded (assessor), randomised clinical trial. Patients between 18-65 years, who have sustained a volar plate injury to a single digit, have adequate cognitive functioning and give written informed consent will be invited to participate in this study. Patients will be randomised to either the control group where they will be fitted with buddy loops and commence early active motion exercises or the experimental group where they will receive a dorsal thermoplastic orthosis in a neutral position and commence early active motion exercises. The primary outcome measure is passive proximal interphalangeal joint extension and secondary outcome measures include passive range of motion, total passive motion, active range of motion, total active motion, grip strength, oedema, pain, function and adherence to treatment. Assessments will be completed until 8 weeks following commencement of treatment. The sample size calculation indicates that 23 patients is required in each group. With an expected dropout rate of 25% a total of 32 patients will be enrolled in each group. DISCUSSION: This study will assist in trying to improve treatment of volar plate injuries and assist in reducing complications associated with volar plate injuries, potentially reducing the need for prolonged hand therapy. TRIAL REGISTRATION: This trial has been registered with the Australian New Zealand Clinical Trials Registry (ACTRN12622001425785p). Ethical approval has been granted by the South Eastern Sydney Local Health District ethical committee (2022/ETH01697).

A CRISPR toolbox for generating intersectional genetic mouse models for functional, molecular, and anatomical circuit mapping.

BACKGROUND: The functional understanding of genetic interaction networks and cellular mechanisms governing health and disease requires the dissection, and multifaceted study, of discrete cell subtypes in developing and adult animal models. Recombinase-driven expression of transgenic effector alleles represents a significant and powerful approach to delineate cell populations for functional, molecular, and anatomical studies. In addition to single recombinase systems, the expression of two recombinases in distinct, but partially overlapping, populations allows for more defined target expression. Although the application of this method is becoming increasingly popular, its experimental implementation has been broadly restricted to manipulations of a limited set of common alleles that are often commercially produced at great expense, with costs and technical challenges associated with production of intersectional mouse lines hindering customized approaches to many researchers. Here, we present a simplified CRISPR toolkit for rapid, inexpensive, and facile intersectional allele production. RESULTS: Briefly, we produced 7 intersectional mouse lines using a dual recombinase system, one mouse line with a single recombinase system, and three embryonic stem (ES) cell lines that are designed to study the way functional, molecular, and anatomical features relate to each other in building circuits that underlie physiology and behavior. As a proof-of-principle, we applied three of these lines to different neuronal populations for anatomical mapping and functional in vivo investigation of respiratory control. We also generated a mouse line with a single recombinase-responsive allele that controls the expression of the calcium sensor Twitch-2B. This mouse line was applied globally to study the effects of follicle-stimulating hormone (FSH) and luteinizing hormone (LH) on calcium release in the ovarian follicle. CONCLUSIONS: The lines presented here are representative examples of outcomes possible with the successful application of our genetic toolkit for the facile development of diverse, modifiable animal models. This toolkit will allow labs to create single or dual recombinase effector lines easily for any cell population or subpopulation of interest when paired with the appropriate Cre and FLP recombinase mouse lines or viral vectors. We have made our tools and derivative intersectional mouse and ES cell lines openly available for non-commercial use through publicly curated repositories for plasmid DNA, ES cells, and transgenic mouse lines.

Effectiveness of sensory adaptive dental environments to reduce psychophysiology responses of dental anxiety and support positive behaviours in children and young adults with intellectual and developmental disabilities: a systematic review and meta-analyses.

BACKGROUND: People with Intellectual and developmental disabilities (IDDs) experience oral health inequality due to myriad of risk factors and complex needs. Sensory processing difficulties, maladaptive behaviours and dental anxiety contribute to difficulties in receiving preventive and routine dental treatments. This study aimed to systematically review the evidence on the effectiveness of sensory adaptive dental environments (SADE) for children and young adults (up to the ages 24 years) with IDD to address cooperation and dental anxiety. METHODS: This review was reported according to The Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA) guidelines. MEDLINE (Ovid), The Cochrane Library, Embase, Google Scholar, Web of Science and OT Seeker were searched using appropriate terms to identify Randomised Control Trails (RCTs) that matched inclusion criteria. Screening was conducted by two reviewers after de-duplication based on titles and abstracts followed by full text retrieval. Quality of the included studies was assessed using Cochrane Risk of Bias (ROB)-2 for crossover trials and data extracted by two reviewers. The details of the interventions and effectiveness were compared and discussed narratively, and comparable outcomes were included to meta-analyses using R software. RESULTS: A total of 622 articles were identified and five articles met eligibility for inclusion. Three studies used multi-sensory adaptations and one used single sensory adaptation of music. Narrative synthesis showed some evidence of SADE reducing magnitude and duration, although, questionable for reducing the number of maladaptive behaviours. Two studies demonstrated conflicting evidence of the effect of SADE on cooperation. Three studies demonstrated significant positive impact of SADE on psychophysiological outcomes. Despite an overall tendency to favour SADE, no statistically significant difference of maladaptive behaviours was found between SADE and regular dental environment (RDE) (Standardised mean change (SMC) = 0.51; 95% Confidence Interval (CI) -0.20 to 1.22; p = 0.161). SADE was superior to RDE (SMC -0.66; 95% CI -1.01 to -0.30; p = < 0.001) in reducing psychophysiological responses of dental anxiety. CONCLUSION: Current evidence suggests that adapting visual, tactile, and auditory aspects of the dental environment in a single or multi-sensory approach demonstrates small positive effects on psychophysiological responses and maladaptive behaviours of dental anxiety for people with IDD. TRIAL REGISTRATION: The title of this review was registered with PROSPERO (CRD42022322083).

Dietary patterns associated with obesity outcomes in adults: an umbrella review of systematic reviews.

OBJECTIVE: The aim of this umbrella review was to summarise the evidence from existing systematic reviews on the association between different dietary patterns (DP) and overweight or obesity outcomes in adults. DESIGN: We followed the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines and searched the MEDLINE, EMBASE, CINAHL, Cochrane, Scopus, and Web of Science for systematic reviews reporting on DP and weight gain or overweight/obesity outcomes. RESULT: We identified 16 systematic reviews with 143 unique studies published between 2001 and 2019. Overall quality scores ranged from 4 to 10. Six reviews in 2/11 cohort and 6/19 cross-sectional studies reported (statistically significant) decreased OR for obesity (range: 0·53 to 0·73 and 0·35 to 0·88, respectively) associated with the Mediterranean diet. Five reviews in 5/15 cohort and 10/45 cross-sectional studies reported an inverse association between diet quality and weight gain or BMI (ß range: -1·3 to -0·09). Two reviews in 1/3 cohort and 1/2 cross-sectional studies reported a decreased risk of obesity (OR = 0·76) and weight gain (OR = 0·26), respectively, with fruit and vegetable intake. Five reviews of mixed DP in 3/40 cross-sectional studies reported an increased prevalence of obesity (OR = 1·19) or abdominal obesity (OR range: 1·07 to 1·27) with the Korean diet pattern. CONCLUSIONS: Our umbrella review confirms the hypothesis that Mediterranean-type DP reduce the risk of obesity in adults. Although population-specific evidence of effective interventions is needed, characteristics of Mediterranean-type DP are important considerations for national obesity prevention strategies.

Augmenting cancer registry data with health survey data with no cases in common: the relationship between pre-diagnosis health behaviour and post-diagnosis survival in oesophageal cancer.

BACKGROUND: For epidemiological research, cancer registry datasets often need to be augmented with additional data. Data linkage is not feasible when there are no cases in common between data sets. We present a novel approach to augmenting cancer registry data by imputing pre-diagnosis health behaviour and estimating its relationship with post-diagnosis survival time. METHODS: Six measures of pre-diagnosis health behaviours (focussing on tobacco smoking, 'at risk' alcohol consumption, overweight and exercise) were imputed for 28,000 cancer registry data records of US oesophageal cancers using cold deck imputation from an unrelated health behaviour dataset. Each data point was imputed twice. This calibration allowed us to estimate the misclassification rate. We applied statistical correction for the misclassification to estimate the relative risk of dying within 1 year of diagnosis for each of the imputed behaviour variables. Subgroup analyses were conducted for adenocarcinoma and squamous cell carcinoma separately. RESULTS: Simulated survival data confirmed that accurate estimates of true relative risks could be retrieved for health behaviours with greater than 5% prevalence, although confidence intervals were wide. Applied to real datasets, the estimated relative risks were largely consistent with current knowledge. For example, tobacco smoking status 5 years prior to diagnosis was associated with an increased age-adjusted risk of all cause death within 1 year of diagnosis for oesophageal squamous cell carcinoma (RR = 1.99 95% CI 1.24,3.12) but not oesophageal adenocarcinoma RR = 1.61, 95% CI 0.79,2.57). CONCLUSIONS: We have demonstrated a novel imputation-based algorithm for augmenting cancer registry data for epidemiological research which can be used when there are no cases in common between data sets. The algorithm allows investigation of research questions which could not be addressed through direct data linkage.

Using estimated probability of pre-diagnosis behavior as a predictor of cancer survival time: an example in esophageal cancer.

BACKGROUND: Information on the associations between pre-diagnosis health behavior and post-diagnosis survival time in esophageal cancer could assist in planning health services but can be difficult to obtain using established study designs. We postulated that, with a large data set, using estimated probability for a behavior as a predictor of survival times could provide useful insight as to the impact of actual behavior. METHODS: Data from a national health survey and logistic regression were used to calculate the probability of selected health behaviors from participant's demographic characteristics for each esophageal cancer case within a large cancer registry data base. The associations between survival time and the probability of the health behaviors were investigated using Cox regression. RESULTS: Observed associations include: a 0.1 increase in the probability of smoking 1 year prior to diagnosis was detrimental to survival (Hazard Ratio (HR) 1.21, 95% CI 1.19,1.23); a 0.1 increase in the probability of hazardous alcohol consumption 10 years prior to diagnosis was associated with decreased survival in squamous cell cancer (HR 1.29, 95% CI 1.07, 1.56) but not adenocarcinoma (HR 1.08, 95% CI 0.94,1.25); a 0.1 increase in the probability of physical activity outside the workplace is protective (HR 0.83, 95% CI 0.81,0.84). CONCLUSIONS: We conclude that probability for health behavior estimated from demographic characteristics can provide an initial assessment of the association between pre-diagnosis health behavior and post-diagnosis health outcomes, allowing some sharing of information across otherwise unrelated data collections.

Validation of a food frequency questionnaire as a tool for assessing dietary intake in cardiovascular disease research and surveillance in Bangladesh.

BACKGROUND: Cardiovascular disease (CVD) has emerged as a major public health concern in Bangladesh. Diet is an established risk factor for CVD but a tool to assess dietary intake in Bangladesh is lacking. This study aimed to validate a food frequency questionnaire (FFQ) using the 24-h dietary recall method and corresponding nutritional biological markers among rural and urban populations of Bangladesh. METHOD: Participants of both genders aged 18-60 years were included in the analysis (total n = 146, rural n = 94 and urban n = 52). Two FFQs of 166 items were administered three-months apart, during which time three 24-h dietary recalls were also completed. Participants were asked to recall their frequency of consumption over the preceding 3 months. Urine and blood samples were collected for comparison between FFQ-estimates of nutrients and their corresponding biomarkers. Methods were compared using unadjusted, energy-adjusted, de-attenuated correlation coefficients, 95% limits of agreement (LOA) and quartile classification. RESULTS: Fair to moderate agreement for ranking energy, macro and micronutrients into quartiles was observed (weighted k value ranged from 0.22 to 0.58; p < 0.001 for unadjusted data) except for vitamin D (weighted k - 0.05) and zinc (weighted k 0.09). Correlation coefficients of crude energy, macronutrients and common micronutrients including vitamin E, thiamine, riboflavin, niacin, pyridoxine, folate, iron, magnesium, phosphorus, potassium, and sodium were moderately good, ranging from 0.42 to 0.78; p < 0.001 but only fair for vitamin A, ß carotene and calcium (0.31 to 0.38; p < 0.001) and poor for vitamin D and zinc (0.02 and 0.16; p = ns, respectively). Energy-adjusted correlations were generally lower except for fat and vitamin E, and in range of - 0.017 (for calcium) to 0.686 (for fat). De-attenuated correlations were higher than unadjusted and energy- adjusted, and significant for all nutrients except for vitamin D (0.017) to 0.801 (for carbohydrate). The Bland Altman tests demonstrated that most of the coefficients were positive which indicated that FFQ provided a greater overestimation at higher intakes. More than one in three participants appeared to overestimate their food consumption based on the ratio of energy intake to basal metabolic rate cut points suggested by Goldberg. Absolute intake of macronutrients was 1.5 times higher and for micronutrients it ranged from 1.07 (sodium) to 26 times (Zinc). FFQ estimates correlated well for sodium (0.32; p < 0.001), and vitamin D (0.20; p = 0.017) with their corresponding biomarkers and iron (0.25; p = 0.003) with serum ferritin for unadjusted data. Folate, iron (with haemoglobin) and total protein showed inverse association; and fat and potassium showed poor correlation with their corresponding biomarkers for unadjusted data. However, folate showed significant positive correlation (0.189; p = 0.025) with biomarker after energy adjustment. CONCLUSION: Although FFQ showed overestimation for absolute intake in comparison with 24-h recalls, the validation study demonstrated acceptable agreement for ranking dietary intakes from FFQ with 24-h recall methods and some biomarkers and therefore could be considered as a tool to measure dietary intake for research and CVD risk factors surveillance in Bangladesh. The instrument may not be appropriate for monitoring population adherence to recommended intakes because of the overestimation.

Follicle-stimulating hormone and luteinizing hormone increase Ca2+ in the granulosa cells of mouse ovarian follicles†.

In mammalian ovarian follicles, follicle stimulating hormone (FSH) and luteinizing hormone (LH) signal primarily through the G-protein Gs to elevate cAMP, but both of these hormones can also elevate Ca2+ under some conditions. Here, we investigate FSH- and LH-induced Ca2+ signaling in intact follicles of mice expressing genetically encoded Ca2+ sensors, Twitch-2B and GCaMP6s. At a physiological concentration (1 nM), FSH elevates Ca2+ within the granulosa cells of preantral and antral follicles. The Ca2+ rise begins several minutes after FSH application, peaks at ∼10 min, remains above baseline for another ∼10 min, and depends on extracellular Ca2+. However, suppression of the FSH-induced Ca2+ increase by reducing extracellular Ca2+ does not inhibit FSH-induced phosphorylation of MAP kinase, estradiol production, or the acquisition of LH responsiveness. Like FSH, LH also increases Ca2+, when applied to preovulatory follicles. At a physiological concentration (10 nM), LH elicits Ca2+ oscillations in a subset of cells in the outer mural granulosa layer. These oscillations continue for at least 6 h and depend on the activity of Gq family G-proteins. Suppression of the oscillations by Gq inhibition does not inhibit meiotic resumption, but does delay the time to 50% ovulation by about 3 h. In summary, both FSH and LH increase Ca2+ in the granulosa cells of intact follicles, but the functions of these Ca2+ rises are only starting to be identified.

The effects of acupuncture on the secondary outcomes of anxiety and quality of life for women undergoing IVF: A randomized controlled trial.

INTRODUCTION: Studies have shown in vitro fertilization (IVF) treatment to have a significant impact on women's quality of life. In addition, anxiety is experienced during IVF treatment and prior to knowing the outcome from a treatment cycle. Although support services are available at many IVF clinics, the uptake of these opportunities may not be high. Acupuncture is used by women undertaking IVF treatment in the belief that it improves their reproductive outcomes, and some studies suggest that it may reduce anxiety. The objective of this study was to examine the effects of acupuncture compared with sham acupuncture on quality of life and anxiety for women undergoing an IVF cycle. MATERIAL AND METHODS: A multicenter randomized controlled trial was conducted in Australia and New Zealand. Women were eligible if they were aged 18-42 years, undergoing a fresh IVF cycle and not using acupuncture. Recruitment occurred between June 2011 and October 2015. Women were randomized to acupuncture or a sham acupuncture control group and three treatments were administered, the first treatment between day 6 and 8 of ovarian stimulation, and two treatments were given on the day of embryo transfer. The primary outcome was livebirth. Secondary outcomes included quality of life and anxiety, and were assessed at baseline, on the day of embryo transfer and 14 weeks from trial entry. RESULTS: In all, 848 women were randomized to the trial, 608 women underwent an embryo transfer, of which 526 (86%) received all three treatments. Adjusted analysis found that women receiving acupuncture reported reduced anxiety following embryo transfer (mean difference [MD] -1.1, 95% CI -2.2 to -0.1, P = 0.03). Unadjusted analysis of quality of life did not differ between groups following embryo transfer. Adjusted analyses by per protocol found a significant positive change for the acupuncture group for the general health MOS Short Form 36 (SF36) domain (MD 2.6, 95% CI 0.5-4.7, P = 0.01) following embryo transfer. The benefit was not sustained at 14 weeks (MD 0.1, 95% CI -2.7 to 2.9). CONCLUSIONS: Acupuncture may reduce anxiety at embryo transfer. Quality of life did not differ between the groups. Women experience reduced emotional well-being 3 months following the IVF cycle, highlighting ongoing unmet psycho-social needs.

A Systematic Review and Meta-Analysis of Rehabilitative Interventions for Unilateral Spatial Neglect and Hemianopia Poststroke From 2006 Through 2016.

OBJECTIVE: To evaluate the effectiveness of activity-based, nonactivity-based, and combined activity- and nonactivity-based rehabilitative interventions for individuals presenting with unilateral spatial neglect (USN) and hemianopia. DATA SOURCES: We searched CINAHL, Cochrane Library, EMBASE, MEDLINE, and PubMed from 2006 to 2016. STUDY SELECTION: Randomized controlled trials (RCTs) with a score of 6 or more in the Physiotherapy Evidence Database Scale that examined the effects of activity-based and nonactivity-based rehabilitation interventions for people with USN or hemianopia. Two reviewers selected studies independently. DATA EXTRACTION: Extracted data from the published RCTs. Mean differences (MD) or standardized mean differences (SMD), and 95% confidence intervals (CIs) were calculated. Heterogeneity was assessed using the I2 statistic. DATA SYNTHESIS: A total of 20 RCTs for USN and 5 for hemianopia, involving 594 and 206 stroke participants respectively, were identified. Encouraging results were found in relation to activity-based interventions for visual scanning training and compensatory training for hemianopia (MD=5.11; 95% confidence intervals [95% CI], 0.83-9.4; P=.019; I2=25.16% on visual outcomes), and optokinetic stimulation and smooth pursuit training for USN (SMD=0.49; 95% CI, 0.01-0.97; P=.045; I2=49.35%) on functional performance in activities of daily living, (SMD=0.96; 95% CI, 0.09-1.82; P=.031; I2=89.57%) on neglect. CONCLUSIONS: Activity-based interventions are effective and commonly used in the treatment of USN and hemianopia. Nonactivity-based and combined approaches, for both impairments, have not been refuted, because more studies are required for substantiated conclusions to be drawn.

A predictive model for non-completion of an intensive specialist obesity service in a public hospital: a case-control study.

BACKGROUND: Despite the growing evidence base supporting intensive lifestyle and medical treatments for severe obesity, patient engagement in specialist obesity services is difficult to achieve and poorly understood. To address this knowledge gap, we aimed to develop a model for predicting non-completion of a specialist multidisciplinary service for clinically severe obesity, termed the Metabolic Rehabilitation Programme (MRP). METHOD: Using a case-control study design in a public hospital setting, we extracted data from medical records for all eligible patients with a body mass index (BMI) of ≥35 kg/m2 with either type 2 diabetes or fatty liver disease referred to the MRP from 2010 through 2015. Non-completion status (case definition) was coded for patients whom started but dropped-out of the MRP within 12 months. Using multivariable logistic regression, we tested the following baseline predictors hypothesised in previous research: age, gender, BMI, waist circumference, residential distance from the clinic, blood pressure, obstructive sleep apnoea (OSA), current continuous positive airway pressure (CPAP) therapy, current depression/anxiety, diabetes status, and medications. We used receiver operating characteristics and area under the curve to test the performance of models. RESULTS: Out of the 219 eligible patient records, 78 (35.6%) non-completion cases were identified. Significant differences between non-completers versus completers were: age (47.1 versus 54.5 years, p < 0.001); residential distance from the clinic (21.8 versus 17.1 km, p = 0.018); obstructive sleep apnoea (OSA) (42.9% versus 56.7%, p = 0.050) and CPAP therapy (11.7% versus 28.4%, p = 0.005). The probability of non-completion could be independently associated with age, residential distance, and either OSA or CPAP. There was no statistically significant difference in performance between the alternate models (69.5% versus 66.4%, p = 0.57). CONCLUSIONS: Non-completion of intensive specialist obesity management services is most common among younger patients, with fewer complex care needs, and those living further away from the clinic. Clinicians should be aware of these potential risk factors for dropping out early when managing outpatients with severe obesity, whereas policy makers might consider strategies for increasing access to specialist obesity management services.

Effect of Acupuncture vs Sham Acupuncture on Live Births Among Women Undergoing In Vitro Fertilization: A Randomized Clinical Trial.

Importance: Acupuncture is widely used by women undergoing in vitro fertilization (IVF), although the evidence for efficacy is conflicting. Objective: To determine the efficacy of acupuncture compared with a sham acupuncture control performed during IVF on live births. Design, Setting, and Participants: A single-blind, parallel-group randomized clinical trial including 848 women undergoing a fresh IVF cycle was conducted at 16 IVF centers in Australia and New Zealand between June 29, 2011, and October 23, 2015, with 10 months of pregnancy follow-up until August 2016. Interventions: Women received either acupuncture (n = 424) or a sham acupuncture control (n = 424). The first treatment was administered between days 6 to 8 of follicle stimulation, and 2 treatments were administered prior to and following embryo transfer. The sham control used a noninvasive needle placed away from the true acupuncture points. Main Outcomes and Measures: The primary outcome was live birth, defined as the delivery of 1 or more living infants at greater than 20 weeks' gestation or birth weight of at least 400 g. Results: Among 848 randomized women, 24 withdrew consent, 824 were included in the study (mean [SD] age, 35.4 [4.3] years); 371 [45.0%] had undergone more than 2 previous IVF cycles), 607 proceeded to an embryo transfer, and 809 (98.2%) had data available on live birth outcomes. Live births occurred among 74 of 405 women (18.3%) receiving acupuncture compared with 72 of 404 women (17.8%) receiving sham control (risk difference, 0.5% [95% CI, -4.9% to 5.8%]; relative risk, 1.02 [95% CI, 0.76 to 1.38]). Conclusions and Relevance: Among women undergoing IVF, administration of acupuncture vs sham acupuncture at the time of ovarian stimulation and embryo transfer resulted in no significant difference in live birth rates. These findings do not support the use of acupuncture to improve the rate of live births among women undergoing IVF. Trial Registration: anzctr.org.au Identifier: ACTRN12611000226909.

Effectiveness of interventions for co-residing family caregivers of people with dementia: Systematic review and meta-analysis.

BACKGROUND/AIM: Occupational therapists and health practitioners commonly provide interventions to family caregivers of people with dementia with the aim of relieving burden, depression, and disruptions in health and social support. To date, the effects of multicomponent interventions specifically targeting these four important outcomes has not been established. The aim of this study was to evaluate the effectiveness of multicomponent interventions on four outcomes for co-residing family caregivers of people with dementia. METHODS: A comprehensive database search of the literature was performed using CINAHL, MEDLINE, PubMed, PsycINFO, OTseeker, EMBASE and the Cochrane library. Randomised control trials (RCTs) that included multicomponent interventions for co-residing family caregivers addressing burden, depression, health and social support were selected. Relevant articles were critically reviewed and study results were synthesised. Meta-analysis was conducted separately. RESULTS: Twenty-two of 358 retrieved studies were selected, with 15 studies being included in the meta-analyses. The multicomponent interventions identified were comprised of a range of different individual strategies. Significant effective results were found for all four specified outcomes. CONCLUSIONS: Many types of multicomponent interventions appear beneficial on all of the four specified outcomes. The literature presents a trend that multicomponent interventions consisting of a combination of counselling, support groups, education, stress and mood management or telephone support are important strategies within an effective multicomponent intervention.

Effect of a 16-week Bikram yoga program on heart rate variability and associated cardiovascular disease risk factors in stressed and sedentary adults: A randomized controlled trial.

BACKGROUND: Chronic activation of the stress-response can contribute to cardiovascular disease risk, particularly in sedentary individuals. This study investigated the effect of a Bikram yoga intervention on the high frequency power component of heart rate variability (HRV) and associated cardiovascular disease (CVD) risk factors (i.e. additional domains of HRV, hemodynamic, hematologic, anthropometric and body composition outcome measures) in stressed and sedentary adults. METHODS: Eligible adults were randomized to an experimental group (n = 29) or a no treatment control group (n = 34). Experimental group participants were instructed to attend three to five supervised Bikram yoga classes per week for 16 weeks at local studios. Outcome measures were assessed at baseline (week 0) and completion (week 17). RESULTS: Sixty-three adults (37.2 ± 10.8 years, 79% women) were included in the intention-to-treat analysis. The experimental group attended 27 ± 18 classes. Analyses of covariance revealed no significant change in the high-frequency component of HRV (p = 0.912, partial η 2 = 0.000) or in any secondary outcome measure between groups over time. However, regression analyses revealed that higher attendance in the experimental group was associated with significant reductions in diastolic blood pressure (p = 0.039; partial η 2 = 0.154), body fat percentage (p = 0.001, partial η 2 = 0.379), fat mass (p = 0.003, partial η 2 = 0.294) and body mass index (p = 0.05, partial η 2 = 0.139). CONCLUSIONS: A 16-week Bikram yoga program did not increase the high frequency power component of HRV or any other CVD risk factors investigated. As revealed by post hoc analyses, low adherence likely contributed to the null effects. Future studies are required to address barriers to adherence to better elucidate the dose-response effects of Bikram yoga practice as a medium to lower stress-related CVD risk. TRIAL REGISTRATION: Retrospectively registered with Australia New Zealand Clinical Trials Registry ACTRN12616000867493 . Registered 04 July 2016.

Combined Lifestyle and Herbal Medicine in Overweight Women with Polycystic Ovary Syndrome (PCOS): A Randomized Controlled Trial.

Polycystic ovary syndrome (PCOS) is a common, complex reproductive endocrinopathy characterized by menstrual irregularities, hyperandrogenism and polycystic ovaries. Lifestyle modification is a first-line intervention; however, there are barriers to success for this form of self-care, and women often seek adjunct therapies including herbal medicines. This pragmatic, randomized controlled trial, delivered in communities of Australia in overweight women with PCOS, compared the effectiveness and safety of a lifestyle intervention plus herbal medicine against lifestyle alone. All participants were helped to construct a personalized lifestyle plan. The herbal intervention consisted of two tablets. Tablet 1 contained Cinnamomum verum, Glycyrrhiza glabra, Hypericum perforatum and Paeonia lactiflora. Tablet 2 contained Tribulus terrestris. The primary outcome was oligomenorrhoea/amenorrhoea. Secondary outcomes were hormones; anthropometry; quality of life; depression, anxiety and stress; pregnancy; birth outcomes; and safety. One hundred and twenty-two women gave their consent. At 3 months, women in the combination group recorded a reduction in oligomenorrhoea of 32.9% (95% confidence interval 23.3-42.6, p < 0.01) compared with controls, estimated as a large effect (ηp2  = 0.11). Other significant improvements were found for body mass index (p < 0.01); insulin (p = 0.02) and luteinizing hormone (p = 0.04); blood pressure (p = 0.01); quality of life (p < 0.01); depression, anxiety and stress (p < 0.01); and pregnancy rates (p = 0.01). This trial provides evidence of improved effectiveness and safety for lifestyle intervention when combined with herbal medicines in women with PCOS. © 2017 The Authors. Phytotherapy Research published by John Wiley & Sons Ltd.

INDIVIDUALIZED YOGA FOR REDUCING DEPRESSION AND ANXIETY, AND IMPROVING WELL-BEING: A RANDOMIZED CONTROLLED TRIAL.

BACKGROUND: Depression and anxiety are leading causes of disability worldwide. Current treatments are primarily pharmaceutical and psychological. Questions remain about effectiveness and suitability for different people. Previous research suggests potential benefits of yoga for reducing depression and anxiety. The aim of this study is to investigate the effects of an individualized yoga intervention. METHODS: A sample of 101 people with symptoms of depression and/or anxiety participated in a randomized controlled trial comparing a 6-week yoga intervention with waitlist control. Yoga was additional to usual treatment. The control group was offered the yoga following the waitlist period. Measures included Depression Anxiety Stress Scale (DASS-21), Kessler Psychological Distress Scale (K10), Short-Form Health Survey (SF12), Scale of Positive and Negative Experience (SPANE), Flourishing Scale (FS), and Connor-Davidson Resilience Scale (CD-RISC2). RESULTS: There were statistically significant differences between yoga and control groups on reduction of depression scores (-4.30; 95% CI: -7.70, -0.01; P = .01; ES -.44). Differences in reduced anxiety scores were not statistically significant (-1.91; 95% CI: -4.58, 0.76; P = .16). Statistically significant differences in favor of yoga were also found on total DASS (P = .03), K10, SF12 mental health, SPANE, FS, and resilience scores (P < .01 for each). Differences in stress and SF12 physical health scores were not statistically significant. Benefits were maintained at 6-week follow-up. CONCLUSION: Yoga plus regular care was effective in reducing symptoms of depression compared with regular care alone. Further investigation is warranted regarding potential benefits in anxiety. Individualized yoga may be particularly beneficial in mental health care in the broader community.

Predictive value of serum testosterone for type 2 diabetes risk assessment in men.

BACKGROUND: Effective prevention of type 2 diabetes (T2D) requires early identification of high-risk individuals who might benefit from intervention. We sought to determine whether low serum testosterone, a novel risk factor for T2D in men, adds clinically meaningful information beyond current T2D risk models. METHODS: The Men Androgen Inflammation Lifestyle Environment and Stress (MAILES) study population consists of 2563 community-dwelling men aged 35-80 years in Adelaide, Australia. Of the MAILES participants, 2038 (80.0 %) provided information at baseline (2002-2006) and follow-up (2007-2010). After excluding participants with diabetes (n = 317), underweight (n = 5), and unknown BMI status (n = 11) at baseline; and unknown diabetes status (n = 50) at follow-up; 1655 participants were followed for 5 years. T2D at baseline and follow-up was defined by self-reported diabetes, or fasting plasma glucose (FPG) ≥7.0 mmol/L (126.1 mg/dL), or glycated haemoglobin (HbA1c) ≥6.5 %, or diabetes medications. Risk models were tested using logistic regression models. Sensitivity, specificity, positive predictive values (PPV) were used to identify the optimal cut-off point for low serum testosterone for incident T2D and the area under the receiver operating characteristic (AROC) curve was used to summarise the predictive power of the model. 15.5 % of men had at least one missing predictor variable; addressed through multiple imputation. RESULTS: The incidence rate of T2D was 8.9 % (147/1655) over a median follow-up of 4.95 years (interquartile range: 4.35-5.00). Serum testosterone level predicted incident T2D (relative risk 0.96 [95 % CI: 0.92,1.00], P = 0.032) independent of current risk models including the AUSDRISK, but did not improve corresponding AROC statistics. A cut-off point of <16 nmol/L for low serum testosterone, which classified about 43 % of men, returned equal sensitivity (61.3 % [95 % CI: 52.6,69.4]) and specificity (58.3 % [95 % CI: 55.6,60.9) for predicting T2D risk, with a PPV of 12.9 % (95 % CI: 10.4,15.8). CONCLUSIONS: Low serum testosterone predicts an increased risk of developing T2D in men over 5 years independent of current T2D risk models applicable for use in routine clinical practice. Screening for low serum testosterone in addition to risk factors from current T2D risk assessment models or tools, including the AUSDRISK, would identify a large subgroup of distinct men who might benefit from targeted preventive interventions.

Efficacy of a Chinese Herbal Medicine in Providing Adequate Relief of Constipation-predominant Irritable Bowel Syndrome: A Randomized Controlled Trial.

BACKGROUND & AIMS: Irritable bowel syndrome (IBS) is the most common chronic functional bowel disorder, with few treatment options. IBS affects 10%-20% of the population; as many as 58% of patients have constipation-predominant IBS (IBS-C). We evaluated efficacy and safety of a standardized, specifically formulated Chinese herbal medicine (CHM) preparation in treatment of patients with IBS-C. METHODS: We performed a double-blind trial of 125 patients with IBS-C (according to Rome III criteria), who were recruited from 13 medical centers or clinics in Australia from July 2009 through February 2012. Patients were randomly assigned to groups given a standardized extract of 7 selected CHM ingredients (n = 61) or placebo (controls, n = 64) for 8 weeks (5 capsules, twice daily). Subjects were then followed for 16 weeks. Chemical definition, standardization, and stability testing of the formulation were completed. Subjects completed a self-administered, validated binary questionnaire of global symptom improvement at weeks 2, 4, 8, and 16 (primary outcome). Secondary outcomes included results from the self-administered IBS Symptom Severity Scale and the Bristol Stool Form Scale (BSFS), which were completed at weeks 4, 8, and 16. RESULTS: There was statistically and clinically significant (per protocol analyses) improvement among subjects who received CHM (n = 50) vs controls (n = 58) for 8 weeks. A greater proportion of subjects receiving CHM reported adequate relief (P = .010). Compared with controls, the CHM group had improved bowel habits vs controls at week 8, including lower IBS Symptom Severity Scale scores (P < .001), reduced straining during defecation (P = .002), and a significant decrease in hard lumpy stools (P = .031). The CHM group also had increased stool consistency, which was based on the Bristol Stool Form Scale (week 8, P < .001). There was no statistically significant difference between groups in abdominal pain at week 8 (P = .692). The CHM was well-tolerated. CONCLUSIONS: In a prospective, controlled study, CHM reduced symptoms of IBS-C, increased bowel satisfaction and stool consistency, and reduced straining and hard lumpy stools, compared with placebo. Clinical trial registration no: ACTRN12609000558224.

Impact of pre-diagnosis behavior on risk of death from esophageal cancer: a systematic review and meta-analysis.

PURPOSE: Most people diagnosed with esophageal cancer will die from their disease, but it is not known whether survival is influenced by pre-morbid behavior. We undertook a systematic review and meta-analysis to investigate the impact of pre-diagnosis behavior on risk of death for esophageal cancer. METHODS: We performed a systematic review of studies reporting on the relationship between pre-diagnosis smoking, alcohol consumption, overweight and obesity, physical activity and regular consumption of nonsteroidal anti-inflammatory drugs, and risk of death from esophageal squamous cell carcinoma (ESCC) and adenocarcinomas (EACs). Study characteristics are presented and aggregate results are compiled using meta-analysis. RESULTS: From an initial pool of 644 non-duplicate records, 13 articles arising from 12 studies met the inclusion criteria. Considerable variation was observed between studies in location, measurement categories, adjustment for other risks, and results. Pooled estimates suggested that for ESCC pre-diagnosis smoking was associated with a 1.19 times [95 % confidence interval (CI) 1.04-1.36] increased risk of death and pre-diagnosis alcohol consumption with a 1.36 times increased risk of death (95 % CI 1.15-1.61). No significant effects were observed for EAC. We observed a lower risk of death for both ESCC and EAC associated with high pre-diagnosis body mass index (BMI) ≥25 kg/m(2) (ESCC hazard ratio 0.80, 95 % CI 0.67-0.95; EAC 0.80, 95 % CI 0.68-0.95), although there was significant heterogeneity across studies. CONCLUSIONS: Our findings suggest that a number of modifiable pre-diagnosis risk factors have a carryover effect on the risk of death from esophageal cancer. These include smoking, drinking alcohol, and BMI.

The influence of neighbourhood green space on children's physical activity and screen time: findings from the longitudinal study of Australian children.

OBJECTIVE: It is often hypothesised that neighbourhood green space may help prevent well-known declines in physical activity and increases in sedentary behaviour that occur across childhood. As most studies in this regard are cross-sectional, the purpose of our study was to use longitudinal data to examine whether green space promotes active lifestyles as children grow older. METHODS: Data came from participants (n = 4983; age = 4-5) of the Longitudinal Study of Australian Children, a nationally representative study on health and child development. Physical activity and screen time were measured biennially (2004-2012) using questionnaires and time use diaries. Quantity of neighbourhood green space was objectively measured using Australian Bureau of Statistics mesh block data for each participant's statistical area level 2. Multilevel regression was used to test for associations between physical activity and screen time with green space quantity, adjusting for socio-economic confounders. RESULTS: Boys living in areas with 10% more neighbourhood green space had a: 7% (95% CI = 1.02, 1.13) greater odds of choosing physically active pastimes; 8% (95 % CI = 0.85, 1.00) lower odds of not enjoying physical activity; 2.3 min reduction in weekend television viewing (95% CI = -4.00, -0.69); and 7% (95% CI = 1.02; 1.12) and 9% (95% CI = 1.03; 1.15) greater odds of meeting physical activity guidelines on weekdays and weekends, respectively. No statistically (or practically) significant results were observed for girls. CONCLUSION: Current provisions of neighbourhood green space may be more amenable to promoting active lifestyles among boys than girls. Research is needed to explore what types of green space promote active lifestyles in all children.