Through the looking glass: understanding non-inferiority

Non-inferiority trials test whether a new product is not unacceptably worse than a product already in use. This paper introduces concepts related to non-inferiority, and discusses the regulatory views of both the European Medicines Agency and the United States Food and Drug Administration

Female reproductive tract infections: understandings and care seeking behaviour among women of reproductive age in Lagos, Nigeria

<p>Abstract</p> <p>Background</p> <p>Reproductive tract infections (RTI's) are endemic in developing countries and entail a heavy toll on women. If untreated, RTI's can lead to adverse health outcomes such as infertility, ectopic pregnancy and increased vulnerability to transmission of the human immunodeficiency virus. It is also associated with adverse pregnancy outcomes. While RTI's and its sequelae abound in Nigeria, there is paucity of publications on the subject in the country. This study assessed the understandings and care seeking behavior with regards to RTI's among women of reproductive age in Lagos, Nigeria with the aim of improving awareness on the subject.</p> <p>Methods</p> <p>A descriptive cross sectional survey of women attending the gynaecological outpatient and family planning clinics of the Lagos State University Teaching Hospital was carried out between 1^stJune 2008 and 31^stAugust 2008 using a pre-tested questionnaire. Data was analysed using the Epi-Info 3.5 statistical software of the Centre for Disease Control and Prevention, Atlanta U.S.A.</p> <p>Results</p> <p>Most of the respondents (77.2%) had heard of RTI's. Toilet was the most perceived mode of contracting RTI's (44.6%), followed by sexual intercourse and poor hygiene. Vaginal discharge was the commonest symptom of RTI's named while inability to get pregnant was the commonest named complication. Majority of the respondent's demonstrated poor overall knowledge of symptoms and complications of RTI"s. 37.4% of the respondents had experienced symptoms of RTI's in the preceding six months. Vaginal discharge was the commonest symptom reported (21.8%) and the majority of those who reported symptoms sought medical treatment. Government health centres were the most visited health facilities for treatment.</p> <p>Conclusion</p> <p>Even though most of the respondents have heard of RTI's and sought treatment when symptomatic, they demonstrated poor overall understanding of the subject. There is need to educate women on preventive strategies, as RTI's are often assymptomatic.</p

Goldstone Boson Scattering with a Light Composite Scalar

The appearance of a light composite $0^+$ scalar resonance in nearly conformal gauge-fermion theories motivates further study of the low energy structure of these theories. To this end, we present a nonperturbative lattice calculation of s-wave scattering of Goldstone bosons in the maximal-isospin channel in SU(3) gauge theory with $N_f=8$ light, degenerate flavors. The scattering phase shift is measured both for different values of the underlying fermion mass and for different values of the scattering momentum. We examine the effect of a light flavor-singlet scalar (reported in earlier studies) on Goldstone boson scattering, employing a dilaton effective field theory (EFT) at the tree level. The EFT gives a good description of the scattering data, insofar as the magnitude of deviations between EFT and lattice data are no larger than the expected size of next-to-leading order corrections in the EFT

Measuring Adiposity in Patients: The Utility of Body Mass Index (BMI), Percent Body Fat, and Leptin

Background: Obesity is a serious disease that is associated with an increased risk of diabetes, hypertension, heart disease, stroke, and cancer, among other diseases. The United States Centers for Disease Control and Prevention (CDC) estimates a 20 % obesity rate in the 50 states, with 12 states having rates of over 30%. Currently, the body mass index (BMI) is most commonly used to determine adiposity. However, BMI presents as an inaccurate obesity classification method that underestimates the epidemic and contributes to failed treatment. In this study, we examine the effectiveness of precise biomarkers and duel-energy x-ray absorptiometry (DXA) to help diagnose and treat obesity. Methodology/Principal Findings: A cross-sectional study of adults with BMI, DXA, fasting leptin and insulin results wer

Neuroprotective Effect of Combination Therapy of Glatiramer Acetate and Epigallocatechin-3-Gallate in Neuroinflammation

Multiple sclerosis (MS) is an inflammatory autoimmune disease of the central nervous system. However, studies of MS and the animal model, experimental autoimmune encephalomyelitis (EAE), indicate that neuronal pathology is the principle cause of clinical disability. Thus, there is need to develop new therapeutic strategies that not only address immunomodulation but also neuroprotection. Here we show that the combination therapy of Glatiramer acetate (GA), an immunomodulatory MS therapeutic, and the neuroprotectant epigallocatechin-3-gallate (EGCG), the main phenol in green tea, have synergistic protective effects in vitro and in the EAE model. EGCG and GA together led to increased protection from glutamate- and TRAIL-induced neuronal cell death in vitro. EGCG combined with GA induced regeneration of hippocampal axons in an outgrowth assay. The combined application of EGCG and GA did not result in unexpected adverse events in vivo. Neuroprotective and neuroregenerative effects could be translated in the in vivo model, where combination treatment with EGCG and GA significantly delayed disease onset, strongly reduced clinical severity, even after onset of symptoms and reduced inflammatory infiltrates. These results illustrate the promise of combining neuroprotective and anti-inflammatory treatments and strengthen the prospects of EGCG as an adjunct therapy for neuroinflammatory and neurodegenerative diseases

A Comparative Exploration of Community Pharmacists' Views on the Nature and Management of Over-the-Counter (OTC) and Prescription Codeine Misuse in Three Regulatory Regimes: Ireland, South Africa and the United Kingdom

Misuse of codeine containing preparations is a public health concern given the potential for associated harms and dependence. This study explores the perspectives of community pharmacists in three regulatory regimes on issues of customer misuse of over-the-counter (OTC) and prescribed codeine. A qualitative design comprising six focus groups (n = 45) was conducted in Ireland, United Kingdom, South Africa. Transcripts were analysed using the constant comparative method of content analysis. Pharmacists described popular codeine-containing products and the need for improved medicine information and warning labels. Issues around legitimate availability of codeine and regulatory status; presence of therapeutic need; difficulties in customer–pharmacist communication; business environments and retail focus were raised. Participants also discussed how they identified customers potentially misusing codeine and difficulties in relationships between pharmacists and prescribers. A number of recommendations were put forward as ways to manage the issues. The study highlights the difficulties encountered by community pharmacists operating under various regulatory regimes when supplying codeine containing preparations in negotiating patient awareness and compliance and potential ways to deal with misuse and dependence

Pre-Admission Statin Use and In-Hospital Severity of 2009 Pandemic Influenza A(H1N1) Disease

In this group of patients hospitalized with pandemic influenza, a significant beneficial effect of pre-admission statin use on the in-hospital course of illness was not identified. Although the database from which these observations are derived represents the largest available suitable UK hospital cohort, a larger study would be needed to confirm whether there is any benefit in this setting

Light Scalar Meson and Decay Constant in SU(3) Gauge Theory with Eight Dynamical Flavors

The SU(3) gauge theory with $N_f=8$ nearly massless Dirac fermions has long been of theoretical and phenomenological interest due to the near-conformality arising from its proximity to the conformal window. One particularly interesting feature is the emergence of a relatively light, stable flavor-singlet scalar meson $\sigma$ $(J^{PC}=0^{++})$ in contrast to the $N_f=2$ theory QCD. In this work, we study the finite-volume dependence of the $\sigma$ meson correlation function computed in lattice gauge theory and determine the $\sigma$ meson mass and decay constant extrapolated to the infinite-volume limit. We also determine the infinite volume mass and decay constant of the flavor-nonsinglet scalar meson $a_0$

Maternal bonding styles in smokers and non-smokers: a comparative study

BACKGROUND: Parental bonding has been implicated in smoking behavior, and the quality of maternal bonding (MB) has been associated with poor mental health and substance use. However, little is known about the association of MB and the smoking of the offspring. METHODS: In our study, 129 smokers and 610 non-smoker medical students completed the parental bonding instrument, which measures MB along two dimensions: care and overprotection. Four categories can be created by high and low scores on care and overprotection: optimal parenting (OP; high care/low overprotection); affectionless control (ALC; low care/high overprotection); affectionate constraint (AC; high care/high overprotection), and neglectful parenting (NP; low care/low overprotection). Nicotine dependence was assessed by the Fagerstrom Nicotine Dependence Test, exhaled CO level, and daily cigarette consumption (CPD). RESULTS: Higher CPD was significantly associated with lower overprotection (p = 0.016) and higher care (p = 0.023) scores. The odds for being a smoker were significantly higher in the neglectful maternal bonding style compared to the other rearing styles (p = 0.022). Besides, smokers showed significantly higher care and lower overprotection scores with the Mann-Whitney U-test than non-smokers, although these associations did not remain significant in multiple regression models. CONCLUSION: Our results indicate that focusing on early life relationship between patient and mother can be important in psychotherapeutic interventions for smoking. Registration trials retrospectively registered