Randomized Placebo-Controlled Clinical Trial of Dutasteride for Reducing Heavy Drinking in Men.

BACKGROUND: Prior studies indicate that neuroactive steroids mediate some of alcohol's effects. Dutasteride, widely used to treat benign prostatic hypertrophy, is an inhibitor of 5-alpha reductase enzymes, which play a central role in the production of 5α-reduced neuroactive steroids. The purpose of this study was to test dutasteride's tolerability and efficacy for reducing drinking. METHODS: Men (n = 142) with heavy drinking (>24 drinks per week) and a goal to either stop or reduce drinking to nonhazardous levels were randomized to placebo or 1 mg dutasteride daily for 12 weeks. We hypothesized that dutasteride-treated patients would be more successful in reducing drinking. RESULTS: Generalized linear mixed models that included baseline drinking, treatment, time and their 2-way interaction identified significant interactions of treatment-time, such that dutasteride treatment reduced drinking more than placebo. During the last month of treatment, 25% of dutasteride-treated participants had no hazardous drinking (no heavy drinking days and not more than 14 drinks per week) compared with 6% of placebo-treated participants (P = 0.006; NNT = 6). Sensitivity analysis identified baseline drinking to cope as a factor associated with larger reductions in drinking for dutasteride compared with placebo-treated participants. Dutasteride was well tolerated. Adverse events more common in the dutasteride group were stomach discomfort and reduced libido. CONCLUSION: Dutasteride 1 mg daily was efficacious in reducing the number of heavy drinking days and drinks per week in treatment-seeking men. The benefit of dutasteride compared with placebo was greatest for participants with elevated baseline drinking to cope motives.

Joint bleeds in mild hemophilia: Prevalence and clinical characteristics.

INTRODUCTION: Joint bleeds are a common and frequent complication associated with hemophilia, increasing the risk of hemophilic arthropathy. It is important to define and characterize the presence of joint complications in mild hemophilia to develop strategies to mitigate disease burden. AIMS: To characterize the prevalence, clinical characteristics of joint bleeds, and risk factors that may lead to hemarthrosis in people with mild hemophilia. METHODS: Following Institutional Review Board approval, a retrospective chart review was conducted for patients with mild hemophilia seen at the Yale Hemophilia Treatment Center or Classical Hematology Program. RESULTS: The medical records of 70 patients were reviewed. Eighty one percent were male and 19 percent were female. Twenty individuals with mild hemophilia had a history of joint bleeding, 13 were traumatic bleeds, 7 were spontaneous. The age of first joint bleed ranged from 4 to 58 years old, with an average age of 20.8-years old. Ten patients developed joint bleeds between the ages of 10 and 20 years old. The most common locations of joint bleeding were the knee (n = 11) and ankle (n = 7). Eight of 70 patients had hepatitis C (HCV), 6 experienced joint bleeding. CONCLUSIONS: In this study, almost one third of patients with mild hemophilia experienced joint bleeding, often without history of trauma. Joint range of motion was abnormal in more than a third of the patients with mild hemophilia regardless. These data highlight the need for ongoing evaluation and characterization of joint health in individuals with mild hemophilia. HIGHLIGHTS: Twenty-nine percent of individuals with mild hemophilia had history of joint bleed. PwH and mild diseases with previous or current hepatitis C had higher likelihood of joint bleeding. Approximately 15% of PwH and mild diseases had abnormal joint examinations without a confirmed history of joint bleeding.

Daily Stress, Drinking Motives and Alcohol Co-Use with Other Drugs.

Background: Recent evidence indicates that alcohol and other substance co-use, compared to alcohol-only use, might be more closely associated with negative reinforcement processes, and thus more likely during periods of increased stress. The present study examined this possibility by using data from an intensive longitudinal (daily) study of college student drinkers (N = 1461, 54% women). We also examined individual differences in coping and enhancement drinking motives as predictors of alcohol and other substance co-use. Results: We used multilevel multinomial logistic regression to predict, relative to alcohol-only days, the likelihood of alcohol co-use with either cigarettes or marijuana, along with alcohol use with multiple substances and other substance-only use from daily interpersonal and academic stress, day-of-the-week, sex, and individual differences in coping and enhancement drinking motives. We found that, relative to alcohol-only, alcohol and marijuana co-use was more likely, and non-alcohol related substance use was less likely, on weekends. Alcohol and marijuana co-use was less likely, and other substance-only use was more likely, on days characterized by greater academic stress, whereas alcohol and cigarette co-use was more likely on days characterized by greater interpersonal stress. Individuals with higher levels of drinking to cope motivation were more likely to engage in alcohol and cigarette co-use, other substance-only use, and alcohol plus multiple substances, relative to alcohol-only. Individuals with higher levels of enhancement motives were more likely to engage in all types of alcohol and other substance co-use and other substance-only use relative to alcohol-only. Conclusions: Findings are discussed in terms of the complex nature of different patterns of co-use patterns when evaluating indicators of positive- and negative-reinforcement processes.

Who Persists and Who Desists? A Prospective Study of Prescription Stimulant Misuse in College Graduates.

Prescription stimulant misuse (PSM) has been studied extensively in college populations, but few studies have examined how PSM changes after graduation. We used a longitudinal design to follow individuals at risk for PSM two years after college graduation to document PSM prevalence, motives, and predictors of PSM persistence. Participants from two small, private colleges completed online surveys focused on intrapersonal, interpersonal, and sociocultural predictors of PSM. Overall, PSM declined over time. Lack of premeditation, perceived peer norms, positive expectancies, media exposure, and other substance use were associated with continued PSM; however, only lack of premeditation, descriptive norms, and other substance use predicted PSM in a multivariate model. This preliminary study suggests dispositional and behavioral risk factors may help to explain why PSM persists after college. Interventions that enhance decision-making skills, correct misperceptions about peers' PSM, and reduce polysubstance use may be effective in curbing PSM in college graduates.

Secondary analysis of a randomized trial testing community health educator interventions for diabetes prevention among refugees with depression: effects on nutrition, physical activity and sleep.

BACKGROUND: Refugees have high levels of psychological distress that hamper lifestyle change efforts. We previously reported that community health educator (CHE) diabetes prevention interventions decreased HbA1c and depressive symptoms among Cambodian-American refugees with depression; this paper reports health behavior outcomes of those interventions. METHODS: Participants were aged 35-75, Khmer speaking, at risk for diabetes, and met study criteria for likely depression by either a) antidepressant medication and/or b) prolonged elevated depressive symptoms. Participants were randomized to one of three CHE interventions: 1) lifestyle intervention called Eat, Walk, Sleep (EWS), 2) EWS plus medication therapy management with a pharmacist/CHE team (EWS + MTM), or, 3) social services (SS; control). Physical activity and sleep were measured with 7 days of actigraphy. Nutrition was measured as carbohydrates as reported in a culturally tailored food frequency questionnaire. Assessments were at baseline, end point (12 months), and follow-up (15 months). RESULTS: The n = 188 participants were 78% female, average age of 55 years, half had a household income < $20,000, and modal education was 7.0 years. Individuals in the two treatment groups that received the EWS intervention significantly increased their brown rice consumption (p < .001, Cohen's d = 0.76) and their moderate-to-vigorous activity (p = .039, d = 0.32). No intervention changed sleep duration, timing, efficiency or wake after sleep onset. Across groups, individuals who increased brown rice consumption, increased vigorous activity and decreased total sleep time variability showed decreased HbA1c, with small effect sizes. CONCLUSIONS: CHEs may improve nutrition and physical activity in refugees with depression but more intensive interventions may be required to impact sleep. Improvements in all three behaviors appear to be associated with HbA1c lowering TRIAL REGISTRATION: ClinicalTrials.gov identifier NCT02502929.

Exposure to Starvation: Associations with HbA1c, Anthropometrics, and Trauma Symptoms Four Decades Later Among Cambodians Resettled in the USA.

BACKGROUND: Epidemiological data suggest that populations exposed to starvation show increased incidence of type 2 diabetes but these studies are limited by lack of person-level data. Cambodians resettled in the USA survived severe malnutrition during distinct historical eras. We examined the relationship of individual exposure to starvation with current HbA1c, anthropometrics, and trauma symptoms among Cambodian Americans. METHODS: Participants were excluded for extant diabetes but all had elevated risk factors for type 2 diabetes and depression. Participants identified images on a 5-point scale that best depicted their body size during four distinct periods: before 1970 (peacetime), 1970-1975 (USA bombing campaign, widespread hunger), 1975-1979 (Pol Pot regime, mass starvation), and "now" (2016-2019, resettled in the USA). They reported trauma symptoms and provided anthropometrics and a blood sample. RESULTS: The n = 189 participants were mean = 55 years old and had glycosylated hemoglobin (HbA1c) mean = 5.5%. Self-reported body size showed excellent validity by strong correlations between body thinness "now" and objectively measured waist circumference (r = -0.35), weight (r = -0.50), and body mass index (r = -0.50). Whereas there was some variability, modal self-reported body size started as normal during peacetime, became thinner during the USA bombing campaign, became emaciated during the Pol Pot regime, and rebounded to normal/slightly heavy "now." Body size during Pol Pot showed the strongest associations with long-term outcomes; thinner body size (greater starvation) was associated with higher trauma symptoms and higher HbA1c even after controlling for age, current waist circumference, and current body mass index. CONCLUSION: Greater degree of starvation was associated with higher HbA1c and trauma symptoms four decades later.

Individual Differences in Affect Dynamics and Alcohol-Related Outcomes.

Background: To examine whether individual differences in intensive longitudinal data-derived affective dynamics (i.e. positive and negative affect variability and inertia and positive affect-negative affect bipolarity) - posited to be indicative of emotion dysregulation - are uniquely related to drinking level and affect-regulation drinking motives after controlling for mean levels of affective states. Method: We used a large sample of college student drinkers (N = 1640, 54% women) who reported on their affective states, drinking levels and drinking motives daily for 30 days using a web-based daily diary. We then calculated from the daily data positive and negative affect variability, inertia, affect bipolarity and mean levels of affect and used these as predictors of average drinking level and affect-regulation drinking motives (assessed using both retrospective and daily reporting methods). Results: Findings from dynamic structural equation models indicated that mean levels of affect were uniquely related to drinking motives, but not drinking level. Few dynamic affect predictors were uniquely related to outcomes in the predicted direction after controlling for mean affect levels. Conclusion: Our results add to the inconsistent literature regarding the associations between affective dynamics and alcohol-related outcomes, suggesting that any effects of these indicators, after controlling for mean affect levels, might be more complex than can be detected with simple linear models.

Search and Rescue in California: The Need for a Centralized Reporting System.

INTRODUCTION: There is no published information on the epidemiology of wilderness rescues in California outside of national parks. The objective of this study was to investigate the epidemiology of wilderness search and rescue (SAR) missions in California and identify risk factors for individuals requiring rescue due to accidental injury, illness, or navigation errors in the California wilderness. METHODS: A retrospective review of SAR missions in California from 2018 to 2020 was conducted. This was done from a database of information collected by the California Office of Emergency Services and the Mountain Rescue Association from SAR teams, who submitted voluntarily. The subject demographics, activity, location, and outcomes of each mission were analyzed. RESULTS: Eighty percent of the initial data were excluded because of incomplete or inaccurate data. Seven hundred forty-eight SAR missions involving 952 subjects were included in the study. The demographics, activities, and injuries of our population were consistent with those reported from other epidemiological SAR studies, and there were significant differences in outcomes based on the subject's activity. For example, water activities were highly correlated with a fatal outcome. CONCLUSIONS: The final data show interesting trends, but it is difficult to draw firm conclusions because so much of the initial data had to be excluded. A uniform system for reporting SAR missions in California may be helpful for further research, which may aid both SAR teams and the recreational public in understanding risk factors. A proposed SAR form for easy entry is included in the discussion section.

Alcohol withdrawal in past-year drinkers with unhealthy alcohol use: Prevalence, characteristics, and correlates in a national epidemiologic survey.

BACKGROUND: Despite its potential to produce serious adverse outcomes, DSM-5 alcohol withdrawal syndrome (AWS) has not been widely studied in the general population. METHODS: We used cross-sectional data from 36,309 U.S. adults from the 2012-2013 National Epidemiologic Survey on Alcohol and Related Conditions-III to examine the past-year prevalence of AWS and its correlates. We focused on an important clinical population-past-year drinkers with unhealthy alcohol use-i.e., those with a positive score on the Alcohol Use Disorders Identification Test-Consumption (AUDIT-C) questionnaire. We also examined the association of AWS with sociodemographic measures, psychiatric disorders, alcohol-related measures, and healthcare utilization. RESULTS: Approximately one-third (n = 12,634) of respondents reported unhealthy alcohol use (AUDIT-C+). Of these, 14.3% met criteria for a DSM-5 AWS diagnosis. The mean (SE) number of withdrawal symptoms among individuals with AWS was 2.83 (1.88), with the most common being nausea/vomiting and insomnia (19.8% and 11.6%, respectively). Among AUDIT-C+ respondents, the odds of AWS were significantly higher among males (adjusted odds ratio [aOR] = 1.17 [95% CI, 1.02-1.33]), unmarried participants (aOR = 1.55 [95% CI, 1.25-1.92]), and those at the lowest (vs. highest) income levels (aOR = 1.62 [95% CI, 1.37-1.92]). Among AUDIT-C+ respondents, AWS was also associated with psychiatric disorders (with aORs that ranged from 2.08 [95% CI, 1.79-2.41]) for major depressive disorder to 3.14 (95% CI, 1.79-2.41) for borderline personality disorder. AUDIT-C+ respondents with AWS also had higher odds of past-year alcohol use disorder (aOR = 11.2 [95% CI, 9.66-13.07]), other alcohol-related features (e.g., binge drinking), and healthcare utilization. CONCLUSIONS: Among individuals with unhealthy alcohol use, AWS is prevalent, highly comorbid, and disabling. Given the risk of AWS among unhealthy drinkers, a comparatively large segment of the general population, clinicians should seek to identify individuals with AWS and intervene with them to prevent serious adverse outcomes.

Post-treatment effects of topiramate on alcohol-related outcomes: A combined analysis of two placebo-controlled trials.

Topiramate reduces drinking and alcohol-related problems and is increasingly being used to treat alcohol use disorder (AUD). In a randomized controlled trial (RCT) of topiramate, rs2832407, a single nucleotide polymorphism (SNP) in the GRIK1 gene moderated topiramate's effects (Study 1). However, a second RCT (Study 2) did not replicate the SNP's moderating effect during treatment. The current analysis combines data from these two studies to examine topiramate's effects on alcohol-related outcomes and on its pharmacogenetic moderation during a 6-month post-treatment period. This analysis includes 308 individuals with problematic alcohol use (67% male; mean age = 51.1; topiramate: 49%, placebo: 51%). It uses generalized linear mixed models to examine changes in self-reported alcohol consumption and alcohol-related problems and concentrations of the liver enzyme γ-glutamyltransferase. The report combines published 3- and 6-month follow-up data from Study 1 with similar, unpublished data from Study 2. Despite robust effects of topiramate on drinking during treatment, the overall multivariate medication effects on outcomes during 3- and 6-month follow-up were not significant (p = 0.08 and p = 0.26, respectively). The moderating effect of the SNP on primary treatment outcomes was also not significant during either follow-up period (p = 0.13 and p = 0.16, respectively). However, during the 3-month post-treatment period, drinks per day was significantly lower in the topiramate group than the placebo group in the rs2832407*CC-genotype group. The robust effects of topiramate on alcohol-related outcomes during treatment diminish substantially once the medication is discontinued. Research is needed both to determine the optimal treatment duration and to identify clinically useful pharmacogenetic moderators of topiramate for treating AUD.

SNAP participation moderates the association between household food insecurity and HbA1c among Cambodian Americans with depression.

OBJECTIVES: We tested whether participation in the Supplemental Nutrition Assistance Program (SNAP) moderated the relation between household food insecurity and HbA1c among Cambodian Americans with depression enrolled in a diabetes prevention trial. METHODS: Community health workers assessed household food insecurity and SNAP participation. HbA1c was ascertained using direct enzymatic assay. RESULTS: Among the n = 189 respondents, 19% were food insecure, 41% received SNAP benefits, and mean HbA1c = 5.5%. There was a significant interaction between SNAP and food insecurity. HbA1c was highest among participants without SNAP who were food insecure. Simple effects analysis revealed a significant difference within the no SNAP group [Mean (SD): Secure = 5.38 (0.38), Insecure = 5.78 (0.36)] and no difference within the SNAP group [Secure = 5.61(0.44), Insecure = 5.61(0.55)]. Differences remained significant after controlling for demographic, socioeconomic, and clinical indicators. CONCLUSIONS: SNAP may protect against the deleterious association between household food insecurity and HbA1c.

Disinfection of Virtual Reality Devices in Health Care Settings: In Vitro Assessment and Survey Study.

BACKGROUND: Virtual reality (VR) devices are increasingly used in health care settings. The use among patients has the potential to unintentionally transmit pathogens between patients and hospital staff. No standard operating procedure for disinfection exists to ensure safe use between patients. OBJECTIVE: This study aims to determine the efficacy of disinfectants on VR devices in order to ensure safe use in health care settings. METHODS: Three types of bacteria were inoculated onto porous and nonporous surfaces of 2 VR devices: the Meta Oculus Quest and Meta Oculus Quest 2. Disinfection was performed using either isopropyl alcohol or alcohol-free quaternary ammonium wipes. A quantitative culture was used to assess the adequacy of disinfection. A survey was separately sent out to VR device technicians at other pediatric health care institutes to compare the methods of disinfection and how they were established. RESULTS: Both products achieved adequate disinfection of the treated surfaces; however, a greater log-kill was achieved on nonporous surfaces than on the porous surfaces. Alcohol performed better than quaternary ammonium on porous surfaces. The survey respondents reported a wide variability in disinfection processes with only 1 person reporting an established standard operating procedure. CONCLUSIONS: Disinfection can be achieved through the use of either isopropyl alcohol or quaternary ammonium products. Porous surfaces showed lesser log-kill rates than the nonporous surfaces, indicating that the use of an added barrier may be of benefit and should be a point of future research. Given the variability in the disinfection process across health care systems, a standard operating procedure is proposed.

Frequency of QTc Interval Prolongation in Children and Adults with Williams Syndrome.

QTc prolongation (≥ 460 ms), according to Bazett formula (QTcB), has been identified to be increased in Williams syndrome (WS) and suggested as a potential cause of increased risk of sudden cardiac death. The Bazett formula tends to overestimate QTc in higher heart rates. We performed a retrospective chart review of WS patients with ≥ 1 electrocardiogram (EKG) with sinus rhythm, no evidence of bundle branch blocks, and measurable intervals. A total of 280 EKGs from 147 patients with WS were analyzed and 123 EKGs from 123 controls. The QTc was calculated using Bazett formula. The average QTcB for individuals with WS and controls was 444 ± 24 ms and 417 ± 26 ms, respectively (p < 0.001). In our WS cohort 34.4% had at least 1 EKG with a QTcB ≥ 460 ms. The mean heart rate (HR) from patients with WS was significantly higher than controls (96 bpm vs 76 bpm, p < 0.001). Linear regression showed that HR contributed 27% to QTcB prolongation in the patients with WS. Patients with WS have a mean QTcB in the normal range but higher than controls, and a higher than expected frequency of QTc ≥ 460 ms compared to the general population. HR is also higher in WS and contributes modestly to the WS QTcB prolongation. Future studies are needed to assess if these findings contribute risk to sudden cardiac death but in the interim we recommend routine EKG testing, especially when starting QTc prolonging medications.

Predictors and outcomes of cyberbullying among college students: A two wave study.

Existing research on cyberbullying has primarily focused on adolescents in cross-sectional survey studies, with less research focusing on college students or employed adults over longer periods of time. To extend this literature, the current study examined new predictors and outcomes of cyberbullying perpetration (CP) and victimization (CV) among college students from two different universities that were followed across two time points. Risk factors were measured in line with previous theoretical models, including biological or personality-related variables (e.g., low self-control, dark-side personality traits, empathy) and environmental variables (e.g., perceived social support, lack of rule clarity, and internet use). Additionally, we examined several possible outcomes of CV and CP. Results from path analyses revealed that involvement with traditional bullying (either as a perpetrator or a victim) as well as Machiavellianism significantly predicted CV and CP. With regard to the cross-lagged associations between CV and CP, we found that Time 1 CV predicted time 2 CP, but Time 1 CP did not predict Time 2 CV. That is, being a victim of cyberbullying during the Fall semester predicted involvement as a perpetrator in the Spring semester. However, being a perpetrator during the Fall semester did not predict being a victim during the Spring semester. Regarding outcomes, we found that CV significantly predicted anxiety, depression, and helping behavior, and CP significantly predicted deviant behavior, but not GPA nor alcohol consumption. These findings have practical implications for college students as well as university student support services.

Pharmacists and community health workers improve medication-related process outcomes among Cambodian Americans with depression and risk for diabetes.

BACKGROUND: Cambodian Americans have high rates of cardiometabolic and psychiatric disorders and disadvantaged social determinants of health (SDOH). These factors can make it challenging to resolve drug therapy problems (DTPs) and improve medication-related outcomes. This manuscript reports planned analyses from a randomized controlled trial in which participants were randomized to one of 3 treatment arms: (1) community health worker (CHW)-delivered lifestyle intervention called Eat, Walk, sleep (EWS), (2) EWS plus pharmacist/CHW-delivered medication therapy management (EWS + MTM), or (3) social services (SS: control). OBJECTIVES: We compared the 3 arms on changes in self-reported medication adherence, barriers, and beliefs. Within the EWS + MTM arm only, we assessed the impact of EWS + MTM on DTP resolution and examined predictors of DTP resolution. METHODS: Cambodian Americans at the age of 35-75 years at high risk of developing diabetes and meeting the criteria for likely depression (N = 188) were randomized (EWS, n = 67; EWS + MTM, n = 63; SS, n = 50; control). For all participants, self-reported surveys were collected at baseline, 12 months, and 15 months. DTPs were assessed on the same schedule but only for participants in the EWS + MTM. RESULTS: All 3 groups reported a significant decrease in barriers to taking medications. Compared with the other arms, the EWS + MTM arm reported a decrease in forgetting to take medications at 15 months. In the EWS + MTM arm, mean DTPs per patient was 6.57 and 84% of DTPs were resolved. SDOH predictors of DTP resolution included years of education (odds ratio [OR] 0.94, P = 0.016), ability to write English (OR 0.73, P = 0.015), difficulty communicating with provider (OR 1.39, P < 0.001), private insurance (OR 1.99, P = 0.030), disability (OR 0.51, P = 0.008), and years living under Pol Pot (OR 0.66, P = 0.045). Medication barriers at baseline predicted DTP resolution (OR 0.79, P = 0.019) such that each additional barrier was associated with a 21% reduction (1-0.79) in the odds of having a resolution. CONCLUSION: CHWs can reduce medications barriers and help pharmacists reduce DTPs in disadvantaged populations.

Observations by health care professionals about wound healing in Ghanaian patients who skin-bleach.

Skin-bleaching is a common practice globally and is associated with many cutaneous and systemic health risks. Anecdotally, skin-bleaching is linked to impairments in wound healing, but there are little data to support the claim. This cross-sectional survey of health care professionals serving the Greater Accra Region, Ghana region investigates their observations of wound healing in patients who skin-bleach and their methods for screening skin-bleach use in patients. A 25-item self-administered questionnaire using 5-point Likert scale was distributed with convenient sampling to physicians and nurses employed at Ghanaian hospitals. Fifty-seven electronic and 78 paper responses were collected (total = 135). Most respondents agreed that wounds in skin-bleaching patients heal more slowly (4.22), are more prone to infection (4.11), haemorrhage (3.89), wound dehiscence (3.9), and are more difficult to manage (4.13). No respondent reported universal screening of all patients for skin-bleaching, but most ask about skin-bleaching if there is suspicion of it (42.2%). Our findings support the anecdotes about observable wound healing impairments in patients who skin-bleach. There is also wide variation in skin-bleaching screening practices, suggesting a need for guidelines to properly identify these patients and facilitate early risk prevention.

Hair cortisol concentrations among urban and rural-dwelling mother-child dyads, La Romana, Dominican Republic.

Hair cortisol concentrations (HCC) were studied in mother-child dyads of La Romana, Dominican Republic (DR), a low-income city, and of the surrounding bateyes, sugarcane plantation villages with inhabitants frequently of Haitian descent. Populations of low socioeconomic status (SES) experience hypothalamic-pituitary-adrenal (HPA) axis dysregulation. Urban communities may be increasingly exposed to stressors such as crime and concentrated poverty whereas rural communities may be devoid of important community resources. As a result, the experience of stress in poverty may differ by place of residence. The goal of this study was to examine differences in HCC among urban and rural-dwelling mother-child dyads in socioeconomically disadvantaged communities surrounding La Romana, DR. Forty-five mother/child dyads were enrolled in La Romana and 45 at several bateyes surrounding La Romana. Mothers were ≥18 years and children were between 7 and 14 years. Mothers self-reported perceived stress and demographic factors. Hair samples were collected from mothers and children, and HCC was assessed using enzyme-linked immunosorbent assays. General linear models examined associations between socioeconomic factors and HCC, and between maternal and child HCC. HCC were measured in 88 maternal and 87 child samples (N = 175). Mothers living in a batey had higher HCC than those living in La Romana (p = 0.001). HCC was positively associated among maternal-child dyads (p = 0.001). Further, Haitian-born mothers as a population who frequently live in a rural batey experienced higher HCC (p = 0.025) that may partially be explained by discriminatory practices in the DR. This research helps to elucidate the impact of urban and rural environmental settings on HCC.Lay summaryThis study focuses on chronic stress, measured by hair cortisol levels, among a low-income population of Dominican and Haitian mother-child pairs who live in urban and rural settings. We found that Haitian-born mothers, who frequently live in a rural batey, had higher hair cortisol levels than Dominican born mothers. Hair cortisol levels between mothers and their children were positively associated. This study addresses the impact of urban and rural environments on the stress response among socioeconomically disadvantaged persons living in an upper middle income country who bear an excessive burden of psychosocial stress.

World Health Organization risk drinking levels as a treatment outcome measure in topiramate trials.

BACKGROUND: Although abstinence has traditionally been considered the only suitable outcome for alcohol treatment, reduced drinking is also associated with improved functioning and medical and psychiatric outcomes. The World Health Organization (WHO) risk drinking levels (RDLs) have been shown to be valid outcome measures in treatment trials for alcohol use disorder (AUD). METHODS: We conducted a secondary analysis of two 12-week, randomized controlled trials (RCTs), in which a total of 308 individuals with problematic alcohol use received topiramate or placebo treatment. We compared the utility of the WHO RDLs with other treatment outcomes, including self-reported measures of alcohol consumption, alcohol-related problems, and quality of life, and the biomarker gamma-glutamyltransferase. RESULTS: Topiramate treatment was associated with small effect sizes for both a 1-level (d = 0.26) and a 2-level (d = 0.19) reduction in WHO RDL, effects that were not significant after correction for multiple comparisons. No heavy drinking days, one of the outcome measures recommended by the US Food and Drug Administration for alcohol medication registration trials, also exhibited a small effect (0.21), while an effect size for abstinence could not be calculated. There were medium effects of topiramate on continuous measures of percent heavy drinking days (d = 0.49) and alcohol-related problems (d = 0.41). CONCLUSIONS: Topiramate is an efficacious pharmacotherapy for AUD. Although continuous measures of drinking and alcohol-related problems yielded larger effect sizes than the WHO RDLs, the latter nonetheless provide a categorical alternative for use in both clinical care and pharmacotherapy trials.

Efficacy and safety of Dentoxol® in the prevention of radiation-induced oral mucositis in head and neck cancer patients (ESDOM): a randomized, multicenter, double-blind, placebo-controlled, phase II trial.

PURPOSE: The aim of this study was to assess the efficacy and safety of Dentoxol mouthrinse in reducing the severity of oral mucositis (OM) secondary to radiation therapy (RT) for head and neck cancer. METHODS: A randomized, double-blind, placebo-controlled, multicenter phase II clinical trial was conducted. Subjects were asked to use Dentoxol (n = 55) or control (n = 53) mouthrinse 5 times/day during RT. Twice a week, OM was assessed clinically using the WHO scale and the Oral Mucositis Daily Questionnaire (OMDQ) was completed. RESULTS: The incidence of severe OM was 40.7% in the Dentoxol group and 51% in the control group (p = 0.265). Comparing all recorded clinical assessments, severe OM was seen in 13.3% of all assessments in the Dentoxol group vs. 21.8% in the control group (p = 0.000). There was a statistically significant lower proportion of assessments showing severe OM in the Dentoxol group at weeks 4, 5, and 6 of RT. The mean duration of severe OM was 11.95 days in the Dentoxol group vs. 14.59 days in the control group (p = 0.502). There was no difference between groups in mouth pain and its impact on function. The use of Dentoxol was safe and was not linked to any serious adverse events. CONCLUSION: The use of Dentoxol 5 times/day is safe and resulted in significantly fewer time-points with severe OM and a delay in the onset of severe OM, compared with a control rinse. A phase III clinical trial is warranted to confirm efficacy and address the limitations of this study.

Inflammation and Stress Biomarkers Mediate the Association between Household Food Insecurity and Insulin Resistance among Latinos with Type 2 Diabetes.

BACKGROUND: Household food insecurity (HFI) is a stressor that is associated with type 2 diabetes (T2D). However, little is known about HFI and the insulin resistance (IR) underlying T2D, and the mechanisms involved. OBJECTIVE: We examined the cross-sectional association between HFI and IR among low-income Latinos with T2D and tested whether inflammation and stress hormones mediated this association. METHODS: HFI was measured with the 6-item US Household Food Security Survey module. IR was calculated from fasting plasma blood glucose and serum insulin. Inflammation was indicated by high-sensitivity C-reactive protein (hsCRP), and stress hormones included urinary cortisol, metanephrine, and normetanephrine. To test for an indirect effect of HFI on homeostasis model assessment of IR, a parallel multiple mediation model was run with biological markers that significantly differed between food security status-entered as mediators in the model. We used 95% bias-corrected bootstrap CIs, with 10,000 bootstrap samples, to assess the significance of the indirect effects. RESULTS: The 121 participants with T2D were primarily Puerto Rican (85.8%), aged mean = 60.7 y, and 74% were female. Eighty-two (68%) were classified as food insecure. Compared with food-secure individuals, food-insecure individuals had a significantly higher IR [mean difference (Δ) = 7.21, P = 0.001], insulin (Δ = 9.7, P = 0.019), glucose (Δ = 41, P < 0.001), hsCRP (Δ = 0.8, P = 0.008), cortisol (Δ = 21, P = 0.045), and total cholesterol (Δ = 29, P = 0.004). Groups did not differ on other lipids, metanephrine, normetanephrine, or A1c. The mediation model showed a significant direct effect of HFI on hsCRP (P = 0.020) and on cortisol (P = 0.011). There was a direct effect of cortisol (P = 0.013), hsCRP (P = 0.044), and HFI on IR (P = 0.015). The total combined indirect effect of HFI through cortisol and hsCRP indicated partial mediation. CONCLUSIONS: Among Latinos with T2D, HFI is associated with IR partially through inflammation and stress hormones. Interventions to ameliorate HFI and mitigate its effects on inflammation, stress, and IR are warranted. This trial was registered at clinicaltrials.gov as NCT01578096.