Weight of evidence needed to substantiate a health effect for probiotics and prebiotics: regulatory considerations in Canada, EU, and US

Successful and responsible introduction of probiotic and prebiotic products into the worldwide marketplace requires labelling for health benefits that meets consumer needs, adheres to regulatory standards and does not overextend scientific evidence. Regulations differ among countries, but underlying all is an emphasis on scientific credibility of any statements of health benefits. This paper considers the value of different types of evidence offered in substantiation of efficacy and reviews different regulatory approaches to labelling for health claims. Limitations of in vitro, animal and different types of human studies used for efficacy substantiation for probiotics and prebiotics are discussed.

Probiotics: their potential to impact human health

Probiotics—live microorganisms that when administered in adequate amounts confer a health benefit on the host—have been studied for both human and animal applications, and worldwide research on this topic has accelerated in recent years. This paper reviews the literature on probiotics, describes how probiotics work in human ecosystems, and outlines the impact of probiotics on human health and disease. The paper also addresses safety issues of probiotic use, suggests future developments in the field of probiotics, and provides research and policy recommendations. Product considerations and potential future developments regarding probiotics also are discussed. The authors conclude that controlled human studies have revealed a diverse range of health benefits from consumption of probiotics, due largely to their impact on immune function or on microbes colonizing the body. Additional, well-designed and properly controlled human and mechanistic studies with probiotics will advance the essential understanding of active principles, mechanisms of action, and degree of effects that can be realized by specific consumer groups. Recommendations include establishment of a standard of identity for the term “probiotic,” adoption of third-party verification of label claims, use of probiotics selectively in clinical conditions, and use of science-based assessment of the benefits and risks of genetically engineered probiotic microbes.

Critical review of health effects of soyabean phyto-oestrogens in post-menopausal women

A consensus view of soyabean phyto-oestrogens in clinical interventions in post-menopausal women is presented that is based on data from the EU-funded project Phytohealth. The phyto-oestrogens, primarily genistein and daidzein, were given as soyabean-protein isolates, whole-soyabean foods or extracts, supplements or pure compounds. A comprehensive literature search was conducted with well-defined inclusion or exclusion criteria. For areas for which substantial research exists only placebo-controlled double-blind randomised controlled trials (RCT) conducted on healthy post-menopausal women were included. For emerging areas all available human studies in post-menopausal women were reviewed. In order to make cross comparisons between studies the doses of isoflavones were calculated as aglycone equivalents. There is a suggestion, but no conclusive evidence, that isoflavones from the sources studied so far have a beneficial effect on bone health. The consumption of whole-soyabean foods and soyabean-protein isolates has some beneficial effects on lipid markers of cardiovascular risk. The consumption of isolated isoflavones does not affect blood lipid levels or blood pressure, although it may improve endothelial function. For menopausal symptoms there is currently limited evidence that soyabean-protein isolates, soyabean foods or red-clover (Trifolium pratense L.) extract are effective but soyabean isoflavone extracts may be effective in reducing hot flushes. There are too few RCT studies to reach conclusions on the effects of isoflavones on breast cancer, colon cancer, diabetes or cognitive function. The health benefits of soyabean phyto-oestrogens in healthy post-menopausal women are subtle and even some well-designed studies do not show protective effects. Future studies should focus on high-risk post-menopausal women, especially in the areas of diabetes, CVD, breast cancer and bone health.

Recommending flavanols and procyanidins for cardiovascular health: current knowledge and future needs

Data on the potential health benefits of dietary flavanols and procyanidins, especially in the context of cardiovascular health, are considerable and continue to accumulate. Significant progress has been made in flavanol analytics and the creation of phytonutrient-content food databases, and novel data emanated from epidemiological investigations as well as dietary intervention studies. However, a comprehensive understanding of the pharmacological properties of flavanols and procyanidins, including their precise mechanisms of action in vivo, and a conclusive, consensus-based accreditation of a causal relationship between intake and health benefits in the context of primary and secondary cardiovascular disease prevention is still outstanding. Thus, the objective of this review is to identify and discuss key questions and gaps that will need to be addressed in order to conclusively demonstrate whether or not dietary flavanols and procyanidins have a role in preventing, delaying the onset of, or treating cardiovascular diseases, and thus improving human life expectancy and quality of life.

The design of probiotic studies to substantiate health claims

The EC Regulation No. 1924/2006 on Nutrition and Health claims made on foods has generated considerable debate and concern among scientists and industry. At the time of writing, the European Food Safety Authority (EFSA) has not approved any probiotic claims despite numerous human trials and meta-analyses showing evidence of beneficial effects. On 29th and 30th September 2010, ten independent, academic scientists with a documented record in probiotic research, met to discuss designs for future probiotic studies to demonstrate health benefits for gut and immune function. The expert panel recommended the following: (i) always formulate a precise and concrete hypothesis, and appropriate goals and parameters before starting a trial; (ii) ensure trials have sufficient sample size, such that they are adequately powered to reach statistically significant conclusions, either supporting or rejecting the a priori hypothesis, taking into account adjustment for multiple testing (this might necessitate more than one recruitment site); (iii) ensure trials are of appropriate duration; (iv) focus on a single, primary objective and only evaluate multiple parameters when they are hypothesis-driven. The panel agreed that there was an urgent need to better define which biomarkers are considered valuable for substantiation of a health claim. As a first step, the panel welcomed the publication on the day of the meeting of EFSA's draft guidance document on immune and gut health, although it came too late for study designs and dossiers to be adjusted accordingly. New validated biomarkers need to be identified in order to properly determine the range of physiological functions influenced by probiotics. In addition, validated biomarkers reflecting risk factors for disease, are required for article 14 claims (EC Regulation No. 1924/2006). Finally, the panel concluded that consensus among scientists is needed to decide appropriate clinical endpoints for trials.

Memory for allergies and health foods: how younger and older adults strategically remember critical health information

Objectives. While older adults often display memory deficits, with practice they can sometimes selectively remember valuable information at the expense of less value information. We examined age-related differences and similarities in memory for health-related information under conditions where some information was critical to remember. Method. In Experiment 1, participants studied three lists of allergens, ranging in severity from 0 (not a health risk) to 10 (potentially fatal), with the instruction that it was particularly important to remember items to which a fictional relative was most severely allergic. After each list, participants received feedback regarding their recall of the high-value allergens. Experiment 2 examined memory for health benefits, presenting foods that were potentially beneficial to the relative’s immune system. Results. While younger adults exhibited better overall memory for the allergens, both age groups in Experiment 1 developed improved selectivity across the lists, with no evident age differences in severe allergen recall by List 2. Selectivity also developed in Experiment 2, although age differences for items of high health benefit were present. Discussion. The results have implications for models of selective memory in older age, and for how aging influences the ability to strategically remember important information within health-related contexts.

Assisted Living: The Politics of Medicaid and Medicare

In this paper I examine the structure of the current assisted living industry in order to explain how and why it is appealing and effective, as well as look at its limitations. I discuss the politics of Medicaid and Medicare, and how through these programs the federal and state governments are failing to provide adequate care for the nation’s senior population. Like the rest of our health care system, these two public health insurance systems are fragmented, and consequently, financing long-term care is complicated and insufficient. Ultimately, this paper will function as a policy report and I will propose: standardized requirements for assisted living facilities; a stricter and new way to regulate assisted living on the state level; restructured models for the public insurance programs, including Medicaid, Medicare, and the State Children’s Health Insurance Program.

Efeito sacietogênico de um novo inibidor de tripsina da paçoca do amendoim com aumento plasmático de colecistocinina (cck)

Obesity is increasing, reaching epidemic levels in many regions of the world. Studies have shown that consumption of peanuts influences on weight control and this influence may be due to the action of trypsin inhibitors sacietogênica that condition increased plasma colescistocinina (CCK). Moreover, the peanut has other health benefits, and these assignments are guaranteed to increase their production and consumption of several of its products, including the paçoca peanut. The aim of this study was to identify the presence of a trypsin inhibitor in paçoca peanut and evaluate its effect on food intake, weight gain and histomorphological changes in swiss mice (n = 8) and Wistar rats (n = 6). Experimental diets were prepared based on the AIN-93G and supplemented with tack or peanut trypsin inhibitor partially purified paçoca peanut (AHTI). After each treatment, the animals were anesthetized and euthanized, their bloods were collected by cardiac puncture for the determination of CCK and other biochemical parameters (glucose, triglycerides, total cholesterol, high density lipoprotein, low density lipoprotein, glutamic-pyruvic transaminase, glutamic oxaloacetic transaminase and albumin) and their pancreas removed for histologic and morphometric analysis. The supplementation with paçoca peanut and the AHTI showed a decrease of body weight gain and food intake in both mice and rats, due to the satiety, since the animals showed no evidence of impairment of nutritional status conditioned by consumption the AHTI. There were also observed biochemical or morphological important when compared with controls. However, AHTI led to increased secretion of CCK, a peptide sacietogênico. Thus, these results indicate that AHTI present in paçoca peanut, is able to enhance the secretion of plasma CCK and thereby reduce the weight gain associated with lower food intake of experimenta animals

Novo sistema de aplicação de drogas em cirurgias oftalmológicas

The topical corneal application of antimitotic mitomycin-C (MMC) during refractive surgery is still characterized by a lack of standardization and considerable empirism. For this reason the creation of a system capable of reliable drug delivery represents a beneficial innovation for patients submitted to these procedures. Objective: Elaborate a new MMC delivery system during the transoperatory period of photorefractive keratectomy (PRK) followed by patent application. Methods: The project consists of an in vitro experimental study to create an MMC (0.02%) release system. The drug was impregnated in sterile Whatman® 41 paper filter discs with a diameter of 8 mm. After drying, the discs were applied to antibiogram plates seeded with Staphylococcus epidermidis (American Type Culture Collection ATCC 12228), followed by the addition of a drop of sterile water. At the end of 1 minute, the discs were removed and the plates incubated for 48 hours at 35oC. Mean drop volume in the collyrium flasks was measured using analytical balance weighing. The inhibition halo (mm) was correlated with the MMC impregnated into the disc. After completion of the invention design a patent application was lodged at the National Institute of Industrial Property. Results: The correspondence between MMC-produced inhibition halos indicated that a dose of 16μg was ideal for impregnating into the discs. The mean drop volume obtained from the collyrium flasks was 37.7 μL. A minute after the application of one drop of balanced saline solution, the system released an adequate concentration for PRK surgery. Conclusion: A new MMC delivery system was created for transoperatory application in photorefractive keratectomy (PRK). Publication of the patent application (number PI 0704739-8) gives the authors exclusive intellectual property rights. The study was sponsored by Ophthalmos Indústria e Comércio de Produtos Farmacêuticos S.A. (São Paulo-SP, Brazil) and received the indispensable scientific contribution of researchers from the fields of Pharmacy, Medicine, Biology, Statistics and Law, characterizing the work as multidisciplinary, in accordance with norms established by the Postgraduate Health Sciences Program of the Federal University of Rio Grande do Norte (UFRN)

Práticas clientelistas e dádivas como estratégias de hegemonia política: uma análise sobre o campo da saúde em Mossoró-RN

The reality experienced by many families and individuals who seek and require the services of the Unified Health System - SUS, the relationships between users, health professionals, and political representatives, establishes the core of the issue that guides the choice and interest of this study concerning the prominence of clientelist practices and gifts that permeate the health field. The research is based on the analysis and reflection of the intrinsic relationship between the health and political fields. It analyses the health field and its relationship with the dynamics and developments of the local political scenario relating it to the implementation of the Family Health Program and Community Health Agents Program (PACS/PSF health programs) in the city of Mossoró, State of Rio Grande do Norte which refers to the period 1991-2010; and falls into a methodological perspective of qualitative approach. The methodological tools and techniques used were based on semi-structured interviews, direct observation of the field, journalistic texts and documentary sources. The construction and questioning of the object of the research were based on theoretical contributions from authors discussing the social field and symbolic power: Bourdieu (2005); clientelist relationships and gifts from asymmetric exchanges: Rouland (1997), Lanna (1995), Martins (1999), Carvalho (1999), Diniz (1982); exercise of hegemony and political strategy from authors who analyse this subject: Gramsci (1995), Coutinho (1981), and Gruppi (1978). Furthermore, the research has established dialogues with authors who address the dynamics of Brazilian politics such as Baquero (2001) and Weffort (1993). The collected data were subjected to qualitative content analysis. The results showed that with the implementation of the PACS/PSF programs in the aforementioned city, the health field has established itself as a key scenario for the exercise of political hegemony of the factions that dominate this socio-political context, resizing clientelist practices, however, without modifying the power structures within this social scenario

O concreto e o simbólico no cotidiano da educação em saúde: práticas, representações e processo identitário dos agentes comunitários de saúde de João Pessoa PB

The present study is about an etnographic research based on the Theory of Social Representation and its complementary approach, the Theory of Central Core based on the bourdiesianos concepts of field and habitus , concerning that these concepts, articulated to the constructed social representation, may contribute to the study of social identities. Its aim is to acknowledge which identity references community health agents (CHA), agents from Community Health Agent Program (CHAP) and Family Health Program (FHP) from João Pessoa PB and which social representation is constructed by them towards health education. The study had the participation of 119 CHAs, from which 90,3 % were female and 9,7% were male. Since the identity is also built by the representation of others towards the group, 63 professionals of the FHP group (16 nurses, 16 nursing assistents, 12 doctors, 9 dentists, 6 dentistry office assistents, 4 coordinators, 1 psicologist and 1 receptionist) and 1 nurse from CHAP took part of the study, oficial documents from the Health Ministry were analyzed, verbal information from its representatives were also taken into consideration, as well as reports from the many benefitiaries of the CHA, CHAP and FHP. For data collecting, we used the combination of (a) Direct Observation and Participant Observation of the functioning micro-areas of the CHA at the Family Health Units, and the Union of the Agents; (b) Free-Association of words and expressions to stimulate the CHA , Health Education and Health ; (c) Questionnaire; (d) Interviews. The interviews were submitted to a thematic analysis of its topic. The free-association was analyzed taking in consideration the vèrgesiana proposal (a combination of the frequency and average order of evocation) which treatment enabled the identification of the central and peripheral systems of social representation towards health education and the community health agent. A test of central refutation, associated to the analysis of the indicated evocations as the most important, provided empirical evidence of social representation towards health education as orientation , prevention and hygiene , as well as the identity of CHA as supervisor , friend , help , important , and the link between the community and the Family Health Staff. Other professionals from CHAP, FHP and the Health Ministry share all of these representational contents, especially the concepts of friend and link , also shared by the community. A habitus towards the community health agents was identified, as a representation based on trust and friendship, which gives the professional a great importance towards the daily inconsistencies faced by the community

Validação do questionário Internacional de Atividade Física (IPAQ) através da acelerometria em idosas

Physical activity is one of the main components of a healthy lifestyle, responsible for many health benefits. Despite being considered important for both disease prevention and health promotion there is high prevalence of sedentary behavior in the elderly population. Questionnaires are practical and feasible instruments for assessing levels of physical activity. However, they may have limitations in older age ranges. Accelerometers, movement sensors that make physical activity data more objective, emerge as reliable measuring devices. Aim: Determine the validity of the International Physical Activity Questionnaire (IPAQ) adapted for elderly with accelerometry in elderly women. Methods: 57 elderly women, with mean age of 66.05 ± 5.98 years who took part in hypertension control and physical activity incentive programs were assessed in relation to objective and subjective measures of physical activity. The accelerometer was used for 07 consecutive days, 24 hours per day before the IPAQ was applied. Data were analyzed using measures of central tendency and dispersion to characterize the sample according to variables collected. To check the validity of the data we used the Spearman correlation test, considering a significance level of p <0.05. Results: With respect to the categories of physical activity obtained by IPAQ, 46.4% developed moderate physical activity, followed by a high (30.3%) and low level (23.2%). There was a negative correlation only between self-reported time spent sitting and time spent on light activities as measured by accelerometry (r = - 0.408; p = 0.003) and mean activity level (counts/min) with physical activity levels evaluated by IPAQ (r = 0.297; p = 0.036). Conclusion: The IPAQ used in elderly women shows moderate to low validity levels according to accelerometry measures. Assessment of sedentary activities exhibited acceptable levels compared to accelerometry; however, moderate (r = 0.096; p > 0.05) to vigorous (r = 0.098; p > 0.05) activities were not correlated, demonstrating the inability of IPAQ to evaluate this type of activity in elderly women

A incorporação da saúde bucal no programa saúde da família do Rio Grande do Norte: investigando a possibilidade de conversão do modelo assistencial

The Health Family Program (HFP) was founded in the 1990s with the objective of changing the health care model through a restructuring of primary care. Oral health was officially incorporated into HFP mainly through the efforts of dental professionals, and was seen as a way to break from oral health care models based on curative, technical biological and inequity methods. Despite the fast expansion of HFP oral health teams, it is essential to ask if changes are really occurring in the oral health model of municipalities. Therefore, the purpose of this study is to evaluate the incorporation of oral health teams into the Health Family Program by analyzing the factors that may interfere positively or negatively in the implementation of this strategy and consequently in the process of changing oral health care models in the National Health System in the state of Rio Grande do Norte, Brazil. This evaluation involves three dimensions: access, work organization and strategies of planning. For this purpose,19 municipalities, geographically distributed according to Regional Public Health Units (RPHU), were randomly selected. The data collection instruments used were: structured interview of supervisors and dentists, structured observation, documental research and data from national health data banks. It was possible to identify critical points that may be impeding the implementation of oral health into HFP, such as, low incomes, no legal employment contract, difficulty in referring patients for high-complexity procedures, in developing intersectoral actions and program strategies such as epidemiologic diagnosis and evaluation of the new actions. The majority of municipalities showed little or no improvement in oral health care after incorporating the new model into HFP. All of them had failures in most of the aspects mentioned above. Furthermore, these municipalities are similar in other areas, such as low educational levels in children from 7 to 14 years of age, high child mortality rates and wide social inequalities. On the other hand, the five municipalities that had improved oral health, according to the categories analyzed, offered better living conditions to the population, with higher life expectancy, low infant mortality rates, per capita income among the highest in the state as well as high Human Development Index (HDI) means. Therefore, it is possible to conclude that public policies that include aspects beyond the health sector are decisive for a real change in health care models

Avaliação da saúde bucal na atenção básica: a perspectiva do usuário

Nowadays, the basic attention in health works according to the Health Family Program (HFP), which is responsible for the organization of the health services with view to provide an appropriate attendance to the needs of the population. Its expansion is expressive in whole country and, the oral health, included in this process, has been seen as a possibility of change the health practices centered in the disease. In face of this perspective, the proposal of study is to discover possible changes in the health care model of oral health in a district, made possible through the perception, evaluation and degree of satisfaction of the user s health service. To reach such objectives, the district of Macaíba in the State of Rio Grande do Norte, was chosen for operational subjects, such as time of implantation of HFP and great covering of this program. The current research used interviews structured with objectives and subjectives questions and questionnaires of socioeconomic characterization addressed to two hundred and seventy (270) individuals (ninety users of an Urban PSF, ninety of a Rural PSF and ninety of an unit non PSF). The analysis of the data was accomplished through the software SPSS/99, that made possible a statistical and analytic appreciation. The HFP units and non HFP units has shown to sort the common odontology problems of the community, and this didn't establish a direct relationship with the general satisfaction. On the other hands, the programmed consultation is related with lager satisfaction of the users. The access form to the odontology treatment of the Units, the satisfaction with the attendance rendered by the dentist and the equip, enough dentists for the community and the social class of the user were decisive for the general satisfaction with the service of oral health. On the other hand, variables as age and education, resolution of the problem and physical conditions of the unit didn't influence the general satisfaction. In spite of the progresses in the implantation of the oral health in ESF, preventive activities, visits at home, access and social participation still reproduce the traditional model of attendance, showing a primary change process

PET-saúde na percepção de estudantes: contribuições para a formação na área de saúde

This dissertation aimed to analyze the perception of students about (EPW Health) Education Program at Work for Health Training in the area of Health. It discusses the proposed theme from the perception of students graduating from the EPW- Health courses participants (dentistry, medicine, physiotherapy, nursing, nutrition, physical education) who have developed their school activities in family health units in the city of João Pessoa between 2009/2011.The program aims policies curricular changes as a potential route of contributions to training in healthcare. Attention is drawn to the new possibilities of working health training contextualized, ethically grounded, socially endorsed. It is pointed out in this process the need to adapt to the demands of professional profiles of SUS (Sistema Único de Saúde). This is an exploratory, descriptive study within a qualitative approach, conducted in the city of João Pessoa in the context of health care courses at the Federal University of Paraiba. The empirical material of this study was treated by the use of technical analysis "Categorical Content Theme" by Bardin. The results indicate prospects for promoting new practices and curricular changes, which highlights the EPW- Health, which has been presenting important experiences in teaching -community -service- with the inclusion of students in the municipal health network. We conclude that the path from collection to data analysis, corroborated with the literature to reaffirm the importance and urgency of change in educational processes with a view to greater proximity to the health needs and the SUS. The EPW- Health project is incipient and requires further investigation in terms of effective interdisciplinary and multidisciplinary character of its proposal