The effectiveness, safety and cost-effectiveness of cytisine versus varenicline for smoking cessation in an Australian population: a study protocol for a randomized controlled non-inferiority trial

Smoking cessation medications are effective but often underutilised because of costs and side effects. Cytisine is a plant-based smoking cessation medication with over 50 years of use in Central and Eastern Europe. While cytisine has been found to be well-tolerated and more effective than nicotine replacement therapy, direct comparison with varenicline have not been conducted. This study evaluates the effectiveness, safety and cost-effectiveness of cytisine compared with varenicline.Two arm, parallel group, randomised, non-inferiority trial, with allocation concealment and blinded outcome assessment.Australian population-based study.Adult daily smokers (N=1266) interested in quitting will be recruited through advertisements and Quitline telephone-based cessation support services.Eligible participants will be randomised (1:1 ratio) to receive either cytisine capsules (25-day supply) or varenicline tablets (12-week supply), prescribed in accordance with the manufacturer's recommended dosing regimen. The medication will be mailed to each participant's nominated residential address. All participants will also be offered standard Quitline behavioural support (up to six 10-12 minute sessions).Assessments will be undertaken by telephone at baseline, 4- and 7-months post-randomisation. Participants will also be contacted twice (two and four weeks post-randomisation) to ascertain adverse events, treatment adherence and smoking status. The primary outcome will be self-reported 6-month continuous abstinence from smoking, verified by carbon monoxide at 7-month follow-up. We will also evaluate the relative safety and cost-effectiveness of cytisine compared with varenicline. Secondary outcomes will include self-reported continuous and 7-day point prevalence abstinence and cigarette consumption at each follow-up interview.If cytisine is as effective as varenicline, its lower cost and natural plant-based composition may make it an acceptable and affordable smoking cessation medication that could save millions of lives worldwide

Socioeconomic differentials in the immediate mortality effects of the national Irish smoking ban

This article has been made available through the Brunel Open Access Publishing Fund.Background: Consistent evidence has demonstrated that smoking ban policies save lives, but impacts on health inequalities are uncertain as few studies have assessed post-ban effects by socioeconomic status (SES) and findings have been inconsistent. The aim of this study was to assess the effects of the national Irish smoking ban on ischemic heart disease (IHD), stroke, and chronic obstructive pulmonary disease (COPD) mortality by discrete and composite SES indicators to determine impacts on inequalities. Methods: Census data were used to assign frequencies of structural and material SES indicators to 34 local authorities across Ireland with a 2000–2010 study period. Discrete indicators were jointly analysed through principal component analysis to generate a composite index, with sensitivity analyses conducted by varying the included indicators. Poisson regression with interrupted time-series analysis was conducted to examine monthly age and gender-standardised mortality rates in the Irish population, ages ≥35 years, stratified by tertiles of SES indicators. All models were adjusted for time trend, season, influenza, and smoking prevalence. Results: Post-ban mortality reductions by structural SES indicators were concentrated in the most deprived tertile for all causes of death, while reductions by material SES indicators were more equitable across SES tertiles. The composite indices mirrored the results of the discrete indicators, demonstrating that post-ban mortality decreases were either greater or similar in the most deprived when compared to the least deprived for all causes of death. Conclusions: Overall findings indicated that the national Irish smoking ban reduced inequalities in smoking-related mortality. Due to the higher rates of smoking-related mortality in the most deprived group, even equitable reductions across SES tertiles resulted in decreases in inequalities. The choice of SES indicator was influential in the measurement of effects, underscoring that a differentiated analytical approach aided in understanding the complexities in which structural and material factors influence mortality

Characteristics of smokers who have never tried to quit: evidence from the British Opinions and Lifestyle Survey

Background An understanding of the characteristics of smokers who have never tried to quit may be useful to help identify and target these individuals and encourage them to attempt to give up smoking. Using national survey data we investigated variables associated with smokers reporting never having tried to quit. Methods Using data from the 2007 and 2009 UK Office for National Statistics Opinions and Lifestyle Survey we identified all self-reported current smokers aged 16+. The primary outcome was response to the question ‘have you ever tried to quit smoking?’ Univariable and multivariable logistic regression quantified the association between this outcome and several potential explanatory variables, including age, sex, socioeconomic status, health status, smoking behaviour, and knowledge of the dangers of smoking. Results Desire to quit was the most significant independent predictor of whether a smoker reported never having tried to quit. Smokers who reported that their health was good or very good were more likely to report never having tried to quit than those whose health was fair, bad or very bad (OR 1.59, 95% CI 1.05-2.41). Smokers who reported that no family members, friends or colleagues had been trying to get them to quit smoking in the last year were more likely to report never having tried to quit than those who reported that someone was trying to persuade them (OR 1.57, 95% CI 1.09-2.28). Smokers who hadn’t received any cessation advice from a health professional in the last five years which they considered to be helpful were also more likely to report never having tried to quit. Conclusions Smokers who do not want to quit, who are in good health, whose friends and family are not trying to get them to quit, and who do not report receiving helpful advice to quit from a health professional, are more likely to report never having tried to quit

Factors associated with self-assessed increase in tobacco consumption among over-indebted individuals in Germany: a cross-sectional study

Background Over-indebtedness is an increasing phenomenon in industrialised nations causing individual hardship and societal problems. Nonetheless, few studies have explored smoking among over-indebted individuals. Methods A cross-sectional survey (n=949) on retrospectively assessed changes in tobacco consumption was carried out in 2006 and 2007 among clients of 84 officially approved debt and insolvency counselling centres in Germany (response rate 39.7%). Logistic regressions were performed to explore factors associated with reports of increased smoking after onset of over-indebtedness. Results 63% of all respondents stated daily or occasional tobacco consumption. Almost one fifth reported an increase in smoking after becoming over-indebted. Females were less likely to report increased smoking than men (aOR 0.66, 95% CI 0.44-0.99) whereas respondents who had been over-indebted for more than 10 years were more likely to report increased smoking than those who had been over-indebted for less than five years (aOR 1.66; 95%-CI 1.00-2.76). The odds of increased smoking were also elevated among those who reported that their families and friends had withdrawn from them as a consequence of their over-indebtedness (aOR 1.82; 95%-CI 1.06-3.14). Conclusions The study identifies over-indebted individuals and particularly over-indebted men as a high-risk group of smokers. Low levels of social embeddedness/support were associated with a further increase in smoking after becoming over-indebted. Given recent increases of over-indebtedness, the findings highlight the need to develop appropriate public health policies

The emergence of health inequalities in early adulthood: evidence on timing and mechanisms from a West of Scotland cohort

Background Evidence is inconsistent as to whether or not there are health inequalities in adolescence according to socio-economic position (SEP) and whether or when they emerge in early adulthood. Despite the large health inequalities literature, few studies have simultaneously compared the relative importance of ?health selection? versus ?social causation? at this life-stage. This study followed a cohort through the youth-adult transition to: (1) determine whether, and if so, when, health inequalities became evident according to both class of origin and current SEP; (2) compare the importance of health selection and social causation mechanisms; and (3) investigate whether these phenomena vary by gender. Methods Data are from a West-of-Scotland cohort, surveyed five times between age 15 (in 1987, N=1,515, response=85%) and 36. Self-reported physical and mental health were obtained at each survey. SEP was based on parental occupational class at 15, a combination of own education or occupational status at 18 and own occupational class (with an additional non-employment category) at older ages. In respect of when inequalities emerged, we used the relative index of inequality to examine associations between both parental and own current SEP and health at each age. In respect of mechanisms, path models, including SEP and health at each age, investigated both inter and intra-generational paths from SEP to health (?causation?) and from health to SEP (?selection?). Analyses were conducted separately for physical and mental health, and stratified by gender. Results Associations between both physical and mental health and parental SEP were non-significant at every age. Inequalities according to own SEP emerged for physical health at 24 and for mental health at 30. There was no evidence of selection based on physical health, but some evidence of associations between mental health in early adulthood and later SEP (intra-generational selection). Paths indicated intra-generational (males) and inter-generational (females) social causation of physical health inequalities, and intra-generational (males and females) and inter-generational (females) social causation of mental health inequalities. Conclusions The results suggest complex and reciprocal relationships between SEP and health and highlight adolescence and early adulthood as a sensitive period for this process, impacting on future life-chances and health

Medicine is patriarchal, but alternative medicine is not the answer

Women are over-represented within alternative medicine, both as consumers and as service providers. In this paper, I show that the appeal of alternative medicine to women relates to the neglect of women’s health needs within scientific medicine. This is concerning because alternative medicine is severely limited in its therapeutic effects; therefore, those who choose alternative therapies are liable to experience inadequate healthcare. I argue that while many patients seek greater autonomy in alternative medicine, the absence of an evidence base and plausible mechanisms of action leaves patients unable to realize meaningful autonomy. This seems morally troubling, especially given that the neglect of women’s needs within scientific medicine seems to contribute to preferences for alternative medicine. I conclude that the liberatory credentials of alternative medicine should be questioned and make recommendations to render scientific medicine better able to meet the needs of typical alternative medicine consumers

Nicotinic receptors mediate stress-nicotine detrimental interplay via dopamine cells’ activity

Epidemiological studies report strong association between mood disorders and tobacco addiction. This high comorbidity requires adequate treatment but the underlying mechanisms are unknown. We demonstrate that nicotine exposure, independent of drug withdrawal effects, increases stress sensitivity, a major risk factor in mood disorders. Nicotine and stress concur to induce long-lasting cellular adaptations within the dopamine (DA) system. This interplay is underpinned by marked remodeling of nicotinic systems, causing increased ventral tegmental area (VTA) DA neurons’ activity and stress-related behaviors, such as social aversion. Blocking β2 or α7 nicotinic acetylcholine receptors (nAChRs) prevents, respectively, the development and the expression of social stress-induced neuroadaptations; conversely, facilitating α7 nAChRs activation specifically in the VTA promotes stress-induced cellular and behavioral maladaptations. Our work unravels a complex nicotine-stress bidirectional interplay and identifies α7 nAChRs as a promising therapeutic target for stress-related psychiatric disorders

The Impact of Body Mass Index and Sociodemographic Factors on Moderate-to-Vigorous Physical Activity and Sedentary Behaviors of Women With Young Children: A Cross-Sectional Examination

OBJECTIVES: Moderate-to-vigorous physical activity provides multiple benefits to women after childbirth. To achieve these benefits, the recommendation that adults obtain, 150 min of moderate-to-vigorous physical activity per week and reduce sedentary behaviors, also applies to women in the post-partum phase of the life span. However, research examining the moderate-to-vigorous physical activity and sedentary behaviors of women with young children (0-2 years) is limited. A greater understanding of these behaviors from a nationally representative sample is needed. Therefore, the primary objective of this study was to determine the levels of moderate-to-vigorous physical activity and sedentary behaviors of a nationally representative sample of women with young children within the United States. A secondary objective was to examine the influence of body mass index and sociodemographic factors on these behaviors. METHODS: Cross-sectional data from four cycles of the National Health and Nutrition Examination Survey (2007-2008, 2009-2010, 2011-2012, and 2013-2014) were used for analysis. Descriptive statistics were calculated and a generalized linear model was used to investigate associations between mean minutes of moderate-to-vigorous physical activity, sedentary activity, body mass index, and sociodemographic variables. DISCUSSION: Women with young children (n = 477) obtained 634 min in moderate-to-vigorous physical activity per week and this was positively associated with having a higher income (p \u3c 0.001) and the number of children in the home (p \u3c 0.001). In total, 62% of women were meeting the World Health Organization guidelines for aerobic activity. Lower odds of achieving guidelines was associated with being Black (p = 0.004), Mexican American (p = 0.009), or married (p = 0.042) compared with being White or not married. Finally, women accumulated ~5 h of sedentary activity per day, with higher levels associated with race (p = 0.005), education (p = 0.022), and number of children within the home (p \u3c 0.001). Research efforts should continue to focus on strategies to help non-adhering women with young children achieve the physical activity recommendations and reduce time spent in sedentary behaviors

Technology Development Roadmap for the Advanced High Temperature Reactor Secondary Heat Exchanger

This Technology Development Roadmap (TDRM) presents the path forward for deploying large-scale molten salt secondary heat exchangers (MS-SHX) and recognizing the benefits of using molten salt as the heat transport medium for advanced high temperature reactors (AHTR). This TDRM will aid in the development and selection of the required heat exchanger for: power production (the first anticipated process heat application), hydrogen production, steam methane reforming, methanol to gasoline production, or ammonia production. This TDRM (a) establishes the current state of molten salt SHX technology readiness, (b) defines a path forward that systematically and effectively tests this technology to overcome areas of uncertainty, (c) demonstrates the achievement of an appropriate level of maturity prior to construction and plant operation, and (d) identifies issues and prioritizes future work for maturing the state of SHX technology. This study discusses the results of a preliminary design analysis of the SHX and explains the evaluation and selection methodology. An important engineering challenge will be to prevent the molten salt from freezing during normal and off-normal operations because of its high melting temperature (390°C for KF ZrF4). The efficient transfer of energy for industrial applications depends on the ability to incorporate cost-effective heat exchangers between the nuclear heat transport system and industrial process heat transport system. The need for efficiency, compactness, and safety challenge the capabilities of existing heat exchanger technology. The description of potential heat exchanger configurations or designs (such as printed circuit, spiral or helical coiled, ceramic, plate and fin, and plate type) were covered in an earlier report (Sabharwall et al. 2011). Significant future work, much of which is suggested in this report, is needed before the benefits and full potential of the AHTR can be realized. The execution of this TDRM will focuses research efforts on the near-term qualification, selection, or maturation strategy as detailed in this report. Development of the integration methodology feasibility study, along with research and development (R&D) needs, are ongoing tasks that will be covered in the future reports as work progresses. Section 2 briefly presents the integration of AHTR technology with conventional chemical industrial processes., See Idaho National Laboratory (INL) TEV-1160 (2011) for further detail