The Efficacy of Paroxetine and Placebo in Treating Anxiety and Depression: A Meta-Analysis of Change on the Hamilton Rating Scales

Background: Previous meta-analyses of published and unpublished trials indicate that antidepressants provide modest benefits compared to placebo in the treatment of depression; some have argued that these benefits are not clinically significant. However, these meta-analyses were based only on trials submitted for the initial FDA approval of the medication and were limited to those aimed at treating depression. Here, for the first time, we assess the efficacy of a selective serotonin reuptake inhibitor (SSRI) in the treatment of both anxiety and depression, using a complete data set of all published and unpublished trials sponsored by the manufacturer. Methods and Findings: GlaxoSmithKline has been required to post the results for all sponsored clinical trials online, providing an opportunity to assess the efficacy of an SSRI (paroxetine) with a complete data set of all trials conducted. We examined the data from all placebo-controlled, double-blind trials of paroxetine that included change scores on the Hamilton Rating Scale for Anxiety (HRSA) and/or the Hamilton Rating Scale for Depression (HRSD). For the treatment of anxiety (k = 12), the efficacy difference between paroxetine and placebo was modest (d = 0.27), and independent of baseline severity of anxiety. Overall change in placebo-treated individuals replicated 79% of the magnitude of paroxetine response. Efficacy was superior for the treatment of panic disorder (d = 0.36) than for generalized anxiety disorder (d = 0.20). Published trials showed significantly larger drug-placebo differences than unpublished trials (d’s = 0.32 and 0.17, respectively). In depression trials (k = 27), the benefit of paroxetine over placebo was consistent with previous meta-analyses of antidepressant efficacy (d = 0.32). Conclusions: The available empirical evidence indicates that paroxetine provides only a modest advantage over placebo in treatment of anxiety and depression. Treatment implications are discussed

Disordered eating and eating disorders among women seeking fertility treatment: A systematic review

The purpose of this systematic review is to evaluate the prevalence of disordered eating and eating disorders among women seeking fertility treatment. Observational studies were searched in Ovid MEDLINE, Web of Science, Embase, and PsycInfo. Studies published prior to September 2020 when the search was conducted were considered. Inclusion criteria included (1) original and empirical research, (2) published in a peer-reviewed journal, and (3) reported on disordered eating among women seeking fertility treatment in the sample or reported on prevalence of eating disorders among women seeking fertility treatment in the sample. Independent screening of abstracts was conducted by two authors (LH and AH). Ten studies met the inclusion criteria. Sample size, study location, measures, and results for each study in this review were reported. Among women pursuing fertility treatment, rates of current eating disorders ranged from 0.5 to 16.7%, while past eating disorder prevalence rates ranged from 1.4 to 27.5%. Current anorexia nervosa or bulimia nervosa was reported by up to 2% and 10.3% of women, respectively, while history of anorexia nervosa or bulimia nervosa was reported by up to 8.5% and 3.3% of women, respectively. Binge eating disorder or other eating disorders were reported by up to 18.5% and 9.1% of women, respectively. Disordered eating pathology was endorsed by 1.6 to 48% of women seeking fertility treatment. Endorsement of pathological eating attitudes was generally higher among women seeking fertility treatment with current or past eating disorders as compared to community samples, with the exception of dietary restraint. Rates of current and past eating disorders are higher among women seeking fertility treatment than in the general population. Providers treating women with infertility should be cognizant of these prevalence rates and consider screening for eating pathology in their patients as this may contribute to their likelihood of successful conception and/or subsequent pregnancy outcomes

Alcohol And Cannabis Use Among Women With Infertility: Associations With Psychological Distress, Attempts To Conceive, And Engagement In Fertility Treatment

Objective: An infertility diagnosis can lead to distress. Although substance use is common and can also lead to distress, little is known about use among those with an infertility diagnosis. This is important since substance use can have implications for fertility. The purpose of this study was to estimate the rate of alcohol and cannabis use among women with infertility and examine whether substance use had associations with psychiatric symptoms, attempts to conceive, and engagement in fertility treatments. Materials and Methods: Patients from one healthcare system were eligible if they received a female infertility diagnosis within the past 2 years. Participants (N=188) completed an online questionnaire on their alcohol use, cannabis use, and psychiatric symptoms. Results: The rates of hazardous alcohol use, any cannabis use, and hazardous cannabis use were 30.3%, 30.9%, and 8.5%, respectively. Hazardous alcohol use was not associated with depression or anxiety (p’s\u3e .05). Those with any cannabis use were more likely to have higher depression scores than those without (p= .02). Those with hazardous cannabis use were also more likely to have higher depression scores (p= .001) and higher anxiety scores (p= .03). Substance use was not associated with actively trying to conceive. However, participants pursuing fertility treatments were less likely to engage in hazardous alcohol use (p= .02). Conclusion: Cannabis use was associated with depression and anxiety scores, suggesting that cannabis may be used for coping. Though many women engage in hazardous alcohol or cannabis use, pursuing fertility treatments may serve as a protective factor

Online randomised factorial trial of electronic Screening and Brief Intervention for alcohol use in pregnancy: a study protocol

INTRODUCTION: Approximately 1 in 7 pregnant women in the USA report past-month alcohol use. Strong evidence connects prenatal alcohol exposure with a range of adverse perinatal outcomes, including the spectrum of conditions known as fetal alcohol spectrum disorders. Screening and Brief Intervention (SBI) has been recommended for pregnant women but has proven difficult to implement. This study will test the efficacy of single-session technology-delivered SBI (electronic SBI) for alcohol use in pregnancy, while simultaneously evaluating the possible additional benefit of tailored text messages and/or booster sessions in a 3×2 factorial trial. METHOD AND ANALYSIS: This full factorial trial will use online advertising and clinic-based flyers to recruit pregnant women meeting criteria for unhealthy alcohol use, and randomly assign them to one of six conditions crossing three levels of brief intervention (none, single 120-minute session and single session plus two 5-minute boosters) with two levels of tailored text messaging (none vs twice weekly messages). The primary analysis will test for dose-response effects of the brief intervention on alcohol abstinence, defined as no self-report of alcohol use in the 90 days prior to 34 weeks\u27 gestation, and negative results for ethyl glucuronide analysis of fingernail samples. Secondary analyses will examine main and interaction effects of tailored text messaging as well as intervention effects on birth outcomes. ETHICS AND DISSEMINATION: Ethical approval was provided by the Michigan State University Biomedical and Health Institutional Review Board (STUDY00005298). Results will be presented at conferences and community forums, in addition to being published in a peer-reviewed journal. Intervention content demonstrating sufficient efficacy and safety will be made publicly available. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov Registry (NCT04332172)

An epidemiological, developmental and clinical overview of cannabis use during pregnancy

The objective of the current narrative literature review is to provide an epidemiological, developmental and clinical overview on cannabis use during pregnancy. Cannabis use in pregnancy poses major health concerns for pregnant mothers and their developing children. Although studies on the short- and long-term consequences of prenatal cannabis exposure are increasing, findings have been inconsistent or difficult to interpret due to methodological issues. Thus, consolidating these findings into clinical recommendations based on the mixed studies in the literature remains a challenge. Synthesizing the available observational studies is also difficult, because some of the published studies have substantial methodological weaknesses. Improving observational studies will be an important step toward understanding the extent to which prenatal exposure to cannabis influences neurodevelopment in the offspring. Therefore, further research on prenatal cannabis exposure and the long-term consequences to offspring health in representative samples are needed to guide and improve clinical care for pregnant women and their children. Future research should also investigate the role of policies on prenatal cannabis use

The moderating effects of contextual factors on the association between violence exposure and substance use among high-risk mothers receiving home visitation services

Violence, substance use, and other parental risk factors associated with adverse child outcomes continue to be primarily conceptualized as individual difficulties, which overlooks the role of context in the development of these risk factors. In contrast, developmental researchers and theorists such as have emphasized the importance of viewing individuals within an ecological-transactional model, whereby the individual and the family are levels within a larger system that includes the neighborhood and larger social contexts. At a practical level, understanding more about the relationships between these factors may help direct efforts to improve family outcomes. This study aims to examine associations between home and neighborhood environments and two particularly relevant parental risk factors--violence exposure and substance use--among high-risk families participating in early home visitation. Results indicated that many of the constructs were associated, and that home environment moderated the association between violence and alcohol use

Human Platelet Gel Supernatant Inactivates Opportunistic Wound Pathogens on Skin

Activation of human platelets produces a gel-like substance referred to as platelet rich plasma or platelet gel. Platelet gel is used clinically to promote wound healing; it also exhibits antimicrobial properties that may aid in the healing of infected wounds. The purpose of this study was to quantify the efficacy of human platelet gel against the opportunistic bacterial wound pathogens Acinetobacter baumannii, Pseudomonas aeruginosa, and Staphylococcus aureus on skin. These opportunistic pathogens may exhibit extensive antibiotic resistance, necessitating the development of alternative treatment options. The antimicrobial efficacy of platelet gel supernatants was quantified using an in vitro broth dilution assay, an ex vivo inoculated skin assay, and in an in vivo skin decontamination assay. Human platelet gel supernatants were highly bactericidal against A. baumannii and moderately but significantly bactericidal against S. aureus in vitro and in the ex vivo skin model. P. aeruginosa was not inactivated in vitro; a low but significant inactivation level was observed ex vivo. These supernatants were quite effective at inactivating a model organism on skin in vivo. These results suggest application of platelet gel has potential clinical applicability, not only in the acceleration of wound healing, but also against relevant bacteria causing wound infections

Comparing Satisfaction, Alliance and Intervention Components in Electronically Delivered and In-person Brief Interventions for Substance Use Among Childbearing-Aged Women

Electronic delivery of Screening, Brief Intervention, and Referral to Treatment (e-SBIRT) may be a low-cost and high-reach method for screening and brief intervention in health care settings. However, its relative acceptability, ability to build a therapeutic alliance, and delivery of key intervention components compared to in-person SBIRT (SBIRT) is unclear. The association of these factors with intervention outcomes is also not known. We compared SBIRT and e-SBIRT on satisfaction, alliance, and receipt of intervention components, and evaluated the extent to which these intervention dimensions were related to later substance use. Data were collected as part of a randomized clinical trial (N = 439) examining SBIRT, e-SBIRT, and enhanced usual care for childbearing-aged women in two reproductive healthcare clinics (see Martino et al. (2018) for main trial findings). Participants receiving SBIRT or e-SBIRT (N = 270) rated satisfaction and alliance following a single-session, brief intervention, based on motivational interviewing that targeted hazardous substance use (tobacco, alcohol, illicit drugs and prescribed medications). Trained raters coded audio-recorded SBIRT sessions for the presence of six major intervention components, and evaluated the occurrence of these components in the e-SBIRT software. Overall, participants in both groups reported strong satisfaction (on average, “considerably” to “extremely” satisfied) and perceived working alliance (on average, “very often” to “always” allied). SBIRT participants provided higher overall alliance ratings, felt more encouraged to make their own decisions, and rated the intervention\u27s likely helpfulness to other women higher. Fewer e-SBIRT participants received intervention components focusing on personalized feedback, developing importance of and confidence in making changes to substance use, and developing a plan to change, compared to SBIRT participants. However, e-SBIRT participants were equally or more likely to receive components seeking to help them understand their use, discussing reasons for use, and summarizing and supporting what the patients elected to do. Notably, satisfaction, alliance, and number of intervention components received were not associated with total days of substance use. Although we found no evidence that the intervention characteristics evaluated in this study were associated with outcomes, acceptability and alliance may have other important implications. Findings suggest areas for improvement with respect to e-SBIRT satisfaction and alliance formation. ClinicalTrials.gov registration number: NCT0153952

Adequacy of prenatal care utilisation and gestational weight gain among women with depression

BACKGROUND: Depression is common during pregnancy, can elevate risk for excessive or inadequate gestational weight gain (GWG), and is associated with both underutilisation and overutilisation of prenatal care. Whether GWG is associated with adequacy of prenatal care among women with and without depression in the United States is unknown. This study evaluated whether adequacy of prenatal care differed by depression status and GWG. METHODS: Data from the Pregnancy Risk Assessment Monitoring System from 1,379,870 women who were pregnant with a singleton and delivered at 37-42 weeks gestation during 2016 to 2018 were included. Depression was self-reported. The Kotelchuck index was used to evaluate adequacy of prenatal care. Maternal weight gain was compared to GWG guidelines. RESULTS: Approximately 13.1% of the sample experienced depression during pregnancy. Although those with depression had increased odds of both inadequate and above adequate levels of prenatal care, this association was no longer significant after accounting for demographics, medical comorbidities, and socioeconomic factors. Individuals with inadequate levels of prenatal care with a normal pre-pregnancy body mass index gained less weight during pregnancy. CONCLUSIONS: The association between depression and prenatal care utilisation seems driven by demographic, medical comorbidity, and socioeconomic variables. Weight outcomes were associated with inadequate prenatal care utilisation