Urban environment and health: a cross-sectional multiregional project based on population health surveys in Spain (DAS-EP project) - study protocol.

INTRODUCTION: The European Environment Agency estimates that 75% of the European population lives in cities. Despite the many advantages of city life, the risks and challenges to health arising from urbanisation need to be addressed in order to tackle the growing burden of disease and health inequalities in cities. This study, Urban environment and health: a cross-sectional multiregional project based on population health surveys in Spain (DAS-EP project), aims to investigate the complex association between the urban environmental exposures (UrbEEs) and health. METHODS AND ANALYSIS: DAS-EP is a Spanish multiregional cross-sectional project that combines population health surveys (PHS) and geographical information systems (GIS) allowing to collect rich individual-level data from 17 000 adult citizens participating in the PHS conducted in the autonomous regions of the Basque Country, Andalusia, and the Valencian Community, and the city of Barcelona in the years 2021-2023. This study focuses on the population living in cities or metropolitan areas with more than 100 000 inhabitants. UrbEEs are described by objective estimates at participants' home addresses by GIS, and subjective indicators present in PHS. The health outcomes included in the PHS and selected for this study are self-perceived health (general and mental), prevalence of chronic mental disorders, health-related quality of life, consumption of medication for common mental disorders and sleep quality. We aim to further understand the direct and indirect effects between UrbEEs and health, as well as to estimate the impact at the population level, taking respondents' sociodemographic and socioeconomic characteristics, and lifestyle into consideration. ETHICS AND DISSEMINATION: The study was approved by the regional Research Ethics Committee of the Basque Country (Ethics Committee for Research Involving Medicinal Products in the Basque Country; PI2022138), Andalusia (Biomedical Research Ethics Committee of the Province of Granada; 2078-N-22), Barcelona (CEIC-PSMar; 2022/10667) and the Valencian Community (Ethics Committee for Clinical Research of the Directorate General of Public Health and Center for Advanced Research in Public Health; 20221125/04). The results will be communicated to the general population, health professionals, and institutions through conferences, reports and scientific articles.

Health literacy: association with socioeconomic determinants and the use of health services in Spain.

Background: Health literacy (HL) is the set of social and cognitive skills that determine person's level of motivation and the ability to access, understand and use information to promote and maintain good health. The aim of this study is to assess the level of health literacy, and to analyze its relationship with sociodemographic variables, state of health, and use of health services in the population aged 15 and over in the Valencian Community (Spain). Methods: Cross-sectional study based on a sample of 5,485 subjects participating in the Health Survey of the Valencia Community. The HLS-EU-Q16 was used. As outcome variables we considered HL categorized into 2 levels: Inadequate or Problematic HL and Sufficient HL and the standardized literacy index. Prevalence rates and HL means were estimated and OR were calculated to analyze the association between variables. Results: A total of 12.8% of the subjects surveyed presented an inadequate or problematic degree of HL. This percentage was higher in people >85 years (63.1%), with a low level of education (46.5%), in retired people (27.4%) or in other work situations (25.0%), in foreigners (18.1%), in low-income people (16.2%), with a perception of poor health status (26.9%), chronic disease (18.5%) or with activity limitations (56.4% severe, 19.7% not severe). Significant differences were found. With the exception of chronic disease, all the variables analyzed were associated with HL. Low HL was associated with a lower consumption of medicines, a greater use of health services, general medical consultations, poorer knowledge of new health technologies and fewer preventive health visits. Conclusion: The percentage of inadequate or problematic HL was globally not very high, but certain population subgroups notably presented a high degree of inadequate or problematic HL. Raising the HL level of such groups should be regarded as a priority. HL was shown to be associated with the service use and new health technology use. Enhancing the population's HL should lead to the following: a greater probability of adopting preventive practices; improving the use of the health system; and boosting people's abilities to manage and to improve their own health.

May Measurement Month 2019: an analysis of blood pressure screening results from Spain.

The aim of the May Measurement Month (MMM) is devoted to better understanding the awareness, treatment, and control rates of hypertension in Spain. Presented here are the data corresponding to 2019 campaign. In 2019, a total of 4433 patients (61.5% males) with a mean age of 54.8 years were included. Of all, 96.0% were Caucasian, and 3294 were recruited in pharmacies. The mean values of systolic blood pressure (BP) were 125.6 and of diastolic 76.7 mmHg in the whole population. The most recent previous BP measurement took place more than 1 year before in 27.6% of participants. A total of 1883 were hypertensive (systolic BP ≥140 mmHg or diastolic BP ≥90 mmHg or taking antihypertensive medication), of whom 77.2%/were aware and 71.1% were on medication. Of all, 64.9% of those on medication and 46.1% of all hypertensive participants had a BP controlled to <140/90 mmHg. These data from MMM 2019 continue to indicate the need for an improvement in the awareness, treatment, and control of hypertension in Spain.

Alfabetización en salud: propiedades psicométricas del cuestionario HLS-EU-Q16 / Health literacy: psychometric behaviour of the HLS-EU-Q16 questionnaire

OBJETIVO: Describir las propiedades psicométricas y el nivel de comprensión del cuestionario de alfabetización en salud HLS-EU-Q16 en español, implementado en la Encuesta de Salud de la Comunitat Valenciana de 2016. MÉTODO: Estudio descriptivo transversal para describir la comprensión, la fiabilidad, la estructura y la consistencia interna del cuestionario sobre la muestra de 5485 sujetos, de 15 o más años de edad, participantes en la encuesta. RESULTADOS: Los porcentajes de comprensión sin mucha dificultad fueron elevados. La fiabilidad fue alta (coeficiente de correlación intraclase: 0,923; kappa: 0,814). El análisis factorial sugirió una estructura unifactorial (79,1% de variabilidad explicada por el factor común), con altas cargas factoriales. La consistencia fue alta (alfa de Cronbach: 0,982). CONCLUSIONES: El HLS-EU-Q16 en español es un instrumento breve, adecuado y válido para medir el nivel de alfabetización en salud de la población

OBJECTIVE: To describe the psychometric properties and the level of understanding of the health literacy questionnaire HLS-EU-Q16 in Spanish, implemented in the Health Survey of the Valencian Region (Spain) of 2016. METHOD: Descriptive cross-sectional study to describe understanding, reliability, structure and internal consistency of the questionnaire on a sample of 5485 subjects, aged 15 or over, who participated in the survey. RESULTS: The percentages of understanding without much difficulty were high. Reliability was high (intraclass correlation coefficient:.923; kappa:.814). The factorial analysis suggested a unifactorial structure (79.1% of variability explained by the common factor), with high factorial loads. The consistency was high (Cronbach's alpha: 0.982). CONCLUSIONS: The HLS-EU-Q16 in Spanish is a short, adequate and valid instrument to measure the level of health literacy in the population

[Health literacy: psychometric behaviour of the HLS-EU-Q16 questionnaire]. / Alfabetización en salud: propiedades psicométricas del cuestionario HLS-EU-Q16.

OBJECTIVE: To describe the psychometric properties and the level of understanding of the health literacy questionnaire HLS-EU-Q16 in Spanish, implemented in the Health Survey of the Valencian Region (Spain) of 2016. METHOD: Descriptive cross-sectional study to describe understanding, reliability, structure and internal consistency of the questionnaire on a sample of 5485 subjects, aged 15 or over, who participated in the survey. RESULTS: The percentages of understanding without much difficulty were high. Reliability was high (intraclass correlation coefficient:.923; kappa:.814). The factorial analysis suggested a unifactorial structure (79.1% of variability explained by the common factor), with high factorial loads. The consistency was high (Cronbach's alpha: 0.982). CONCLUSIONS: The HLS-EU-Q16 in Spanish is a short, adequate and valid instrument to measure the level of health literacy in the population.

La información al paciente sobre los servicios profesionales farmacéuticos asistenciales de farmacia comunitaria / Information to patients on professional pharmaceutical care services of Community Pharmacy

La prestación de servicios profesionales farmacéuticos asistenciales (SPFA) al paciente des-de la farmacia comunitaria ha de realizarse observando una serie de garantías sanitarias y legales previas que aseguren los derechos del paciente. Toda actuación en el ámbito de la salud de un paciente necesita su consentimiento libre y voluntario una vez que haya recibido la in-formación adecuada. Esta información que, como regla general, se proporcionará verbalmente (salvo en los casos de procedimientos invasivos, que son los que entrañan riesgos más graves), ha de ser veraz e incluir como mínimo la finalidad y la naturaleza de cada intervención, sus riesgos y sus consecuencias, y se debe comunicar al paciente de forma comprensible y adaptada a sus necesidades, de forma que le ayude a tomar decisiones de acuerdo con su propia y libre voluntad. De este modo, para que el paciente consienta que se le preste un SPFA ha de recibir previamente una información específica sobre dicho servicio. Aunque esta información se po-dría proporcionar solo verbalmente, al ser los SPFA servicios novedosos con los que el paciente no está familiarizado, es recomendable proporcionarla también por escrito ya que esta vía per-mite garantizar que se comunica de forma uniforme, comprensible, evitando equivocaciones y olvidos, y además el paciente tendrá más tiempo para estudiarla en su casa. Este artículo analiza la información mínima que se debe proporcionar a los pacientes y usuarios en la prestación de los SPFA. Además, muestra como ejemplo tanto la información que se proporciona al paciente en cinco de los SPFA que gestiona la aplicación SEFAC e_XPERT®, como un modelo de consen-timiento informado válido para dichos servicios y que incluye el resto de información necesaria que también se debe comunicar previamente al paciente

The provision of professional pharmaceutical care services (SPFA) to the patient from the community pharmacy must be carried out by observing a series of previous health and legal guarantees that ensure the rights of the patient. Any action in the area of a patient’s health requires his or her free and voluntary consent once he or she had received the appropriate information. This information will, as a general rule, be provided orally (except in the case of invasive procedures, which are the ones with the most serious risks), must be truthful and include at least the purpose and nature of each intervention, its risks and its consequences, and must be communicated to the patient in a way that is understandable and adapted to his or her needs, in a way that helps you make decisions according to your own free will. Thus, in order for the patient to consent to the provision of an SPFA, he must first receive specific information about that service. Although this information could be provided only verbally, as SPFAs are novel services with which the patient is not familiar, it’s advisable to provide it also in writing, as this way ensures that it communicates uniformly, comprehensively, avoiding mistakes and forgetfulness, and also that the patient will have more time to study it at home. This article discusses the minimum information to be provided to patients and users in the provision of SPFA. In addition, it shows, as an example, the information provided to the patient in five of the SPFA that manage the SEFAC e_XPERT®application, as well as an informed consent model which includes all other necessary information which must also be communicated to patient

Contribution of the Economic Crisis to the Risk Increase of Poor Mental Health in a Region of Spain.

Previous research suggests that the economic crisis can affect mental health. The purpose of this study was to analyse the association of risk of poor mental health with various socioeconomic, demographic, health, quality of life, and social support variables; and to evaluate the contribution of socioeconomic variables most affected by the beginning of the economic crisis (employment situation and income) on the changes in the prevalence of the risk of poor mental health between 2005 and 2010. A study of prevalence evolution in adult population residents of the Valencian Community in the Spanish Mediterranean was conducted. We studied 5781 subjects in 2005 and 3479 in 2010. Logistic regression models have been adjusted to analyse the association between variables. A standardisation procedure was carried out to evaluate which part of the changes in overall prevalence could be attributed to variations in the population structure by age, sex, employment status, and income between the years under study. The prevalence of GHQ+ increased from 2005 to 2010, in both men and women. Several variables were closely associated with the risk of poor mental health (sex, age, country of birth, number of nonmental chronic diseases, social support, disability, cohabitation in couple, employment status, and income). The changes produced as a result of the onset of the economic crisis in income and unemployment (increase in low income and in unemployment rates) contributed to the increase of poor mental health risk. This could confirm the sensitivity of mental health to the economic deterioration caused by the crisis.

Comparison of the efficacy and tolerability of chondroitin plus glucosamine and D-002 (beeswax alcohols) in subjects with osteoarthritis symptoms.

BACKGROUND/AIMS: Osteoarthritis (OA), the commonest joint disorder, is a leading cause of disability. Symptomatic slow-acting drugs for OA (SYSADOA), particularly glucosamine plus chondroitin sulphate (GS/CS), are effective for symptom relief, protect joint cartilage and delay OA progression, with a good safety profile. D-002, a mixture of beeswax alcohols that inhibits both cyclooxygenase and 5-lipoxygenase activities, has been effective in experimental and clinical OA studies, showing also a chondroprotective effect. OBJECTIVES: To compare the effects of D-002 and GS/SC administered for 12 weeks on OA symptoms. METHODS: Participants were randomized to GS/CS (375/300 mg) or 50 mg D-002 once daily for 12 weeks. Symptoms were assessed by the Western Ontario and McMaster Individual Osteoarthritis Index (WOMAC) and the Visual Analogy Scale (VAS) scores. The primary outcome was the reduction of the total WOMAC score. Secondary outcomes included WOMAC pain, stiffness and function scores, VAS score and rescue medication consumption. RESULTS: Of 60 randomized patients, 59 completed the study. D-002 and GS/SC reduced significantly total WOMAC score (72.1% and 78.5%, respectively), and pain, joint stiffness and physical function scores versus baseline. VAS scores decreased significantly with D-002 (76.6%) and GS/SC (76.8%). The reductions, significant from the second week, were enhanced over the trial. Rescue medications were consumed by 3/30 D-002 and 4/30 GS/SC patients. No differences between groups were found. Treatments were well tolerated. CONCLUSIONS: D-002 (50 mg/day) administered for 12 weeks was safe and comparable to GS/SC for alleviating OA symptoms (pain, stiffness, and functional limitation) (RPCEC00000180).

Inhibition of cyclooxygenase (COX) and 5-lipoxygenase (5-LOX) by D-005 (A lipid extract of Acrocomia crispa fruits) / [Inhibición de la ciclooxigenasa (COX) y la 5-lipooxigenasa (5-LOX) por el D-005 (extracto lipidico del fruto de la Acrocomia crispa)

This study was aimed to investigate whether the a lipid extract from Acrocomia crispa fruits (D-005) inhibits COX and 5-LOX enzyme activities in vitro. This study demonstrates that D-005 inhibits markedly and in a dose dependent manner COX-2 and 5-LOX activities. The dual inhibition of COX-2 and 5-LOX supports further research on the potential anti-inflammatory effect of D-005.

El objetivo de este estudio fue investigar si el extracto lipídico de los frutos de Acrocomia crispa (D-005) inhibe in vitro las actividades de las enzimas COX y 5-LOX. Este estudio demuestra que el D-005 inhibe marcadamente y de manera dosis dependiente las actividades de la COX-2 y 5-LOX. La inhibición dual de la COX-2 y 5-LOX soportan futuras investigaciones sobre el potencial efecto anti-inflamatorio del D-005.

Efecto a largo plazo del policosanol en la recuperación funcional de pacientes con ictus isquémico no cardioembólico: estudio de un año / Long-term eff ect of policosanol on the functional recovery of non-cardioembolic ischemic stroke patients: a one year study

Introducción. El ictus es una causa principal de mortalidad y discapacidad. El policosanol ha sido efi caz en modelos de isquemia cerebral. Este estudio investiga si el tratamiento a largo plazo con policosanol, añadido a la terapia con ácido acetilsalicílico (AAS), dentro de los 30 días posteriores a un ictus, es mejor que el placebo + AAS en la recuperación de los pacientes. Pacientes y métodos. Estudio aleatorizado, doble ciego, controlado con placebo. Se incluyeron 80 pacientes (edad media: 69 años) que sufrieron un ictus en los 30 días previos y con una puntuación de 2-4 en la escala de Rankin modifi cada(mRS). Se distribuyeron aleatoriamente en dos grupos y recibieron policosanol + AAS o placebo + AAS durante 12 meses. Resultados. El tratamiento con policosanol + AAS disminuyó signifi cativamente la puntuación en la mRS desde el primer control intermedio (1,5 meses). El efecto del tratamiento incluso mejoró con la terapia a largo plazo. El número de pacientes que alcanzaron valores de mRS menores o iguales a 1 fue superior en el grupo de policosanol + AAS (87,5%) que en el de placebo + AAS (0%). El tratamiento con policosanol + AAS aumentó signifi cativamente el índice de Barthel, disminuyó el colesterol LDL y aumentó el colesterol HDL frente a placebo + AAS. Conclusiones. El tratamiento a largo plazo (12 meses) con policosanol + AAS fue más efectivo que el tratamiento con placebo + AAS en la recuperación funcional de los pacientes después de sufrir un ictus isquémico no cardioembólico de moderada gravedad (AU)

Introduction. Stroke is a leading cause of mortality and disability. Policosanol has been eff ective in brain ischemia models. The aim of this study is to investigate whether policosanol, added to aspirin therapy within 30 days of stroke onset, is better than placebo + aspirine for the long-term recovery of non-cardioembolic ischemic stroke subjects. Patients and methods. Randomized, double-blind, placebo-controlled study. Eighty patients (mean age: 69 years) within 30 days of onset, with a modifi ed Rankin Scale score (mRS) 2 to 4, were included. They were randomized in two groups (policosanol + aspirine or placebo + aspirine) for 12 months. Results. Policosanol + aspirine decreased signifi cantly mean mRS from the fi rst interim check-up (1.5 months). The treatment even improved after long-term therapy. More policosanol + aspirin (87.5%) than placebo + aspirine (0%) patients achieved mRSs ≤ 1. Policosanol + aspirine increased signifi cantly Barthel Index, lowered LDL-cholesterol and increased HDL-cholesterol versus placebo + aspirin. Conclusions. Long-term (12 months) administration of policosanol + aspirin given after suff ering non-cardioembolic ischemic stroke was shown to be better than placebo + aspirin in improving functional outcomes when used among patients with non-cardioembolic ischemic stroke of moderate severity (AU)

Effects of a Combined Therapy With D-002 (Beeswax Alcohols) Plus D-003 (Sugarcane Wax Acids) on Osteoarthritis Symptoms.

Context • Nonsteroidal, anti-inflammatory drugs effectively relieve osteoarthritis (OA) symptoms but also induce adverse effects (AEs) that limit their long-term use, which drives a search for safer treatments. D-002, a mixture of beeswax alcohols, and D-003, a mixture of sugarcane wax acids, have been effective in experimental and clinical studies for patients with OA. Objective • The study intended to investigate the effects on OA symptoms of a combined therapy using D-002 and D-003 (D-002/D-003), which were administered for 6 wk. Design • The study was a randomized, double-blind, placebo-controlled trial. Setting • The study was conducted at the Surgical Medical Research Center in Havana, Cuba. Participants • Participants were patients with mild-to-moderate OA. Intervention • Participants were randomly assigned to 1 of 4 groups-(1) a control group, which received a placebo; (2) the D-002 group (intervention group), which received 50 mg/d of D-002; (3) the D-003 group (intervention group), which received 10 mg/d of D-003; or (4) the D-002/D-003 group (intervention group), which received a combined therapy of 50 mg/d of D-002 plus 10 mg/d of D-003. The control group received tablets that were indistinguishable in appearance from the D-002 and D-003 tablets and had a similar composition, except that the active ingredients were replaced by lactose. The groups took the medications once per day for 6 wk. Outcome Measures • Symptoms were assessed using the Western Ontario and McMaster Individual Osteoarthritis Index (WOMAC) and a visual analogue scale (VAS). The primary outcome was the reduction in the total WOMAC score. The subscale scores on the WOMAC for pain, stiffness, and physical function, the VAS scores, and the use of rescue medications were secondary outcomes. Results • Of the 120 enrolled participants, 116 completed the study. The treatments with D-002, D-003, and D-002/D-003 reduced the mean total WOMAC scores significantly from baseline to postintervention, by 75.1%, 72.8%, and 91.2%, respectively. Compared with the placebo, the treatments decreased the mean WOMAC scores for pain, joint stiffness, and physical function significantly. The VAS scores significantly decreased, showing a 71.4%, a 66.9%, and an 84.7% reduction for the D-002, D-003, and D-002/D-003 groups, respectively. All the reductions were significant from the first week and were enhanced during the trial. The D-002/D-003 treatment was more effective in improving all of the scores than either monotherapy. With respect to rescue medications, 3/30, 2/30, and 2/30 used the medications in the D-002, D-003, and D-002/D-003 groups, respectively, vs 17/30 in the control group. The treatments were well tolerated. Conclusions • Administered for 6 wk, 50 mg/d of D-002 and 10 mg/d of D-003 ameliorated OA symptoms, but the combined therapy, D-002/D-003, was more effective than either monotherapy. All treatments were well tolerated.

D-004 ameliorates phenylephrine-induced urodynamic changes and increased prostate and bladder oxidative stress in rats.

BACKGROUND: Lower urinary tract symptoms (LUTS) in patients with benign prostatic hyperplasia (BPH) mainly depend on alpha1-adrenoreceptors (α1-ADR) stimulation, but a link with oxidative stress (OS) is also involved. D-004, a lipid extract of Roystonea regia fruits, antagonizes ADR-induced responses and produces antioxidant effects. The objective of this study was to investigate whether D-004 produce antioxidant effects in rats with phenylephrine (PHE)-induced urodynamic changes. METHODS: Rats were randomized into eight groups (ten rats/group): a negative vehicle control and seven groups injected with PHE: a positive control, three treated with D-004 (200, 400 and 800 mg/kg) and three others with tamsulosin (0.4 mg/kg), grape seed extract (GSE) (250 mg/kg) and vitamin E (VE) (250 mg/kg), respectively. RESULTS: Effects on urinary total volume (UTV), volume voided per micturition (VM), malondialdehyde (MDA) and carbonyl groups (CG) concentrations in prostate and bladder homogenates were study outcomes. While VM and UTV lowered significantly in the positive control as compared to the negative control group, the opposite occurred with prostate and bladder MDA and CG values. D-004 (200-800 mg/kg) increased significantly both VM and UTV, lowered significantly MDA in prostate and bladder homogenates, and reduced GC levels only in the prostate. Tamsulosin increased significantly VM and UTV, but unchanged oxidative variables. GSE and VE unchanged the UTV, whereas VE, not GSE, modestly but significantly attenuated the PHE-induced decrease of VM. CONCLUSIONS: Single oral administration of D-004 (200-800 mg/kg) was the only treatment that ameliorated the urodynamic changes and reduced increased oxidative variables in the prostate of rats with PHE-induced prostate hyperplasia.

Protective effects of D-002 on experimentally induced gastroesophageal reflux in rats.

AIM: To investigate the effects of beeswax alcohols (D-002) on the esophageal damage induced by gastroesophageal reflux (GER) in rats. METHODS: Sixty male rats were randomized into six groups (10 rats/group): a negative control and five groups with experimentally induced GER: a positive vehicle control, three treated with D-002 (25, 100 and 200 mg/kg, respectively), and one with omeprazole 10 mg/kg. All treatments were given by gastric gavage. One hour after dosing, GER was produced by simultaneous ligation of the pyloric end and the forestomach. Esophageal lesions index (ELI), gastric secretion volume and acidity, and esophageal malondialdehyde (MDA) and sulfhydryl (SH) group concentrations were measured. Statistical significance was considered at P < 0.05. RESULTS: As compared to the negative control, the positive control group exhibited increased ELI (5.2 ± 0.33 vs 0 ± 0, P = 0.0003), gastric secretion volume (2.69 ± 0.09 vs 0.1 ± 0.0, P = 0.0003) and acidity (238 ± 19.37 vs 120.0 ± 5.77, P = 0.001), and esophageal concentrations of MDA (2.56 ± 0.1 vs 1.76 ± 0.28, P = 0.001) and SH groups (1.02 ± 0.05 vs 0.56 ± 0.08, P = 0.0003). D-002 (25, 100 and 200 mg/kg) reduced ELI (3.36 ± 0.31, 2.90 ± 0.46 and 2.8 ± 0.23, respectively) vs the positive control (5.2 ± 0.33) (P = 0.004; P = 0.002; P = 0.001, respectively). There were no significant changes in acidity with D-002 treatment, and only the highest dose reduced the volume of the gastric secretion (1.92 ± 0.25) vs the positive control (2.69 ± 0.09, P = 0.013). D-002 (25, 100 and 200 mg/kg) lowered the esophageal MDA (2.05 ± 0.16, 1.98 ± 0.22 and 1.93 ± 0.22, respectively) (P = 0.01; P = 0.03; P = 0.03, respectively) and SH group concentration (0.87 ± 0.06, 0.79 ± 0.08 and 0.77 ± 0.06, respectively) (P = 0.04; P = 0.04; P = 0.02) vs the positive control (2.56 ± 0.10 and 1.02 ± 0.05, respectively). Omeprazole decreased ELI (2.54 ± 0.47), gastric secretion volume (1.97 ± 0.14) and acidity (158.5 ± 22.79), esophageal MDA (1.87 ± 0.13) and SH group (0.72 ± 0.05) concentrations vs the positive control (P = 0.002; P = 0.001; P = 0.02; P = 0.003; P = 0.002, respectively). CONCLUSION: Acute oral administration of D-002 decreased macroscopic esophageal lesions and oxidative stress in rats with experimentally induced GER, without modifying gastric secretion acidity.

Evaluation of the effect of D-002, a mixture of beeswax alcohols, on osteoarthritis symptoms.

BACKGROUND/AIMS: Nonsteroidal anti-inflammatory drugs relieve osteoarthritis (OA) symptoms but cause adverse effects. D-002, a mixture of beeswax alcohols, is effective against experimental OA. A pilot study found that D-002 (50 mg/day) for 8 weeks improves OA symptoms. The aim of this study was to investigate the effects of D-002 (50 to 100 mg/day) administered for 6 weeks on OA symptoms. METHODS: Patients with OA symptoms were double-blindly randomized to D-002 (50 mg) or placebo for 6 weeks. Symptoms were assessed by the Western Ontario and McMaster Individual Osteoarthritis Index (WOMAC) and the visual analog scale (VAS) scores. Patients without symptom improvement at week 3 were titrated to two daily tablets. The primary outcome was the total WOMAC score. WOMAC pain, joint stiffness and physical function scores, VAS score, and use of rescue medications were secondary outcomes. RESULTS: All randomized patients (n = 60) completed the study, and 23 experienced dose titration (two in the D-002 and 21 in the placebo groups). At study completion, D-002 reduced total WOMAC (65.4%), pain (54.9%), joint stiffness (76.8%), and physical function (66.9%) WOMAC scores, and the VAS score (46.8%) versus placebo. These reductions were significant beginning in the second week, and became enhanced during the trial. The use of rescue medication by the D-002 (6/30) group was lower than that in the placebo (17/30) group. The treatment was well tolerated. Seven patients (two in the D-002 and five in the placebo group) reported adverse events. CONCLUSIONS: These results indicate that D-002 (50 to 100 mg/day) for 6 weeks ameliorated arthritic symptoms and was well tolerated.

Effects of D-002, a mixture of high molecular weight beeswax alcohols, on patients with nonalcoholic fatty liver disease.

BACKGROUND/AIMS: Nonalcoholic fatty liver disease (NAFLD) is intimately related to insulin resistance and ranges from a benign course to liver fibrosis and cirrhosis. NAFLD management mainly involves dietary modification and weight loss. Although no fully successful pharmacological intervention is available, alternative therapies to treat NAFLD have shown promising results. Experimental studies have shown that D-002, a mixture of beeswax alcohols with antioxidant effects, is hepatoprotective. The aim of this study was to investigate the efficacy and safety of D-002 in patients with NALFD. METHODS: Fifty patients with NAFLD were randomized to receive a placebo or D-002 (100 mg/day) for 24 weeks. The primary endpoint was a significant ultrasonography-detected reduction of liver fat infiltration versus a placebo. Secondary endpoints were decreases in the homeostatic model assessment (HOMA) index, insulin levels, serum liver enzymes, increases in plasma total antioxidant status (TAS) and improved clinical symptoms versus the placebo recipients. RESULTS: At randomization, all indicators were comparable in both groups. At study completion, seven (28.0%) D-002-patients, but none of the placebo recipients, exhibited a normal liver echo pattern on ultrasonography (p < 0.01). Also, D-002 significantly reduced (p < 0.01 vs. baseline and placebo) the HOMA index and insulin levels and increased the TAS, but did not affect other parameters. The proportion of D-002-patients (12/25, 48.0%) showing symptom improvement was higher (p < 0.001) than that of the placebo group (1/25, 4.0%). The treatment was safe and well tolerated. Three patients in each group withdrew from the study. CONCLUSIONS: D-002 (100 mg/day) improved ultrasonographic findings, indicators of insulin resistance, plasma TAS and clinical evolution on NAFLD patients. Further studies, however, are needed to confirm these results.

Protective effect of D-002, a mixture of beeswax alcohols, against indomethacin-induced gastric ulcers and mechanism of action.

D-002, a mixture of higher aliphatic beeswax alcohols, produces gastroprotective and antioxidant effects. To investigate the gastroprotective effect of D-002 against indomethacin-induced ulcers, oxidative variables and myeloperoxidase (MPO) activity in the rat gastric mucosa were examined. Rats were randomized into six groups: a negative vehicle control and five indomethacin (50 mg/kg) treated groups, comprising a positive control, three groups treated orally with D-002 (5, 25 and 100 mg/kg) and one group with omeprazole 20 mg/kg intraperitoneally (ip). The contents of malondialdehyde (MDA), protein carbonyl groups (PCG), hydroxyl radical generation and catalase (CAT), glutathione peroxidase (GSH-PX), superoxide dismutase (SOD) and MPO enzyme activities in the rat gastric mucosa were assessed. Indomethacin increased the content of MDA and PCG, the generation of *OH radical and MPO enzyme activity, while it decreased the CAT, GSH-PX and SOD activities as compared to the negative controls. D-002 (5-100 mg/kg) significantly and dose-dependently reduced indomethacin-induced ulceration to 75 %. Also, D-002 decreased the content of MDA and PCG, the generation of hydroxyl radicals and MPO activity as compared to the positive controls. The highest dose of D-002 (100 mg/kg) increased significantly GSH-PX and SOD activities, while all doses used increased CAT activities. Omeprazole 20 mg/kg, the reference drug, reduced significantly the ulcers (93 %), MDA and PCG, the generation of hydroxyl radicals and MPO activity, and increased the CAT, GSH-PX and SOD activities. D-002 treatment produced gastroprotective effects against indomethacin-induced gastric ulceration, which can be related to the reduction of hydroxyl radical generation, lipid peroxidation, protein oxidation and MPO activity, and to the increase of the antioxidant enzymes activities in the rat gastric mucosa.

Effectiveness of Dader Method for pharmaceutical care on control of blood pressure and total cholesterol in outpatients with cardiovascular disease or cardiovascular risk: EMDADER-CV randomized controlled trial.

BACKGROUND: Although some studies have demonstrated that pharmacist intervention can improve drug therapy among patients with cardiovascular disease (CVD), more evidence derived from randomized controlled trials (RCTs) is needed, including assessment of the effect of community pharmacist interventions in patients with CVD. OBJECTIVE: To assess the effectiveness of the Dader Method for pharmaceutical care on achieving therapeutic goals for blood pressure (BP), total cholesterol (TC), and both BP and TC (BP/TC) in patients with CVD and/or high or intermediate cardiovascular (CV) risk attending community pharmacies in Spain. METHODS: Patients aged 25 to 74 years attending community pharmacies with a prescription for at least 1 drug indicated for CVD or CV risk factors were randomized to 2 groups: an intervention group that received pharmaceutical care, which was provided by specially trained pharmacists working in collaboration with physicians, and a control group that received usual care (routine dispensing counseling) and verbal and written counseling regarding CVD prevention. Patients were recruited from December 2005 to September 2006, and both groups were followed for 8 months. Study outcomes were assessed at baseline and at 16 and 32 weeks after randomization. The primary outcome measures were the proportions of patients achieving BP, TC, and BP/TC therapeutic goals (BP lower than 140/90 mm Hg for patients with uncomplicated hypertension and lower than 130/80 mm Hg for patients with diabetes, chronic kidney disease, or history of myocardial infarction or stroke; TC lower than 200 mg per dL for patients without CVD and lower than 175 mg per dL for patients with CVD). Secondary outcomes were mean BP and TC values. BP was assessed manually by the pharmacist after a 10-minute rest in the supine position. This measurement was performed twice for every participant, and the average of the 2 measurements was calculated. TC was measured by the pharmacist during the study visit using the enzymatic dry method. Statistical analyses were performed using 2-tailed McNemar tests, Pearson chi-square tests, and Student's t-tests; P < 0.05 was considered statistically significant. RESULTS: 714 patients were included in the study (356 intervention, 358 control), and the mean [SD] age was 62.8 [8.1] years. The 2 groups were similar at baseline in clinical and demographic characteristics, including the proportion of patients at therapeutic goals for BP, TC, and BP/TC. After 8 months of follow-up, there were statistically significant differences in favor of pharmaceutical care in the proportions of patients who achieved therapeutic goals for BP (52.5% vs. 43.0%, P=0.017), TC (56.5% vs. 44.1%, P=0.001), and BP/TC (37.1% vs. 21.8%, P < 0.001). CONCLUSION: Compared with usual care plus written education, pharmaceutical care focused on patient evaluation and follow-up in collaboration with physicians improved the achievement of BP, TC, and BP/TC treatment goals in patients with CVD and/or high or intermediate CV risk attending community pharmacies in Spain.

Effect of D-003, a Mixture of High Molecular Weight Aliphatic Acids, on Glucocorticoid- and Lipopolysaccharides (LPS)-Induced Osteonecrosis.

Osteonecrosis (ON) is characterized through the impairment of osseous blood flow that leads to the collapse of femur head. Corticoid-induced ON in rats and lipopolysaccharide (LPS)-induced in rabbits are useful models to assess the efficacy of potential treatments on this disease. D-003 inhibits the mevalonate pathway, lipid peroxidation and prevents osteoporosis in rats through increasing the osteoclast apoptosis. This study investigated the effects of D-003 on corticoid- and LPS-induced ON in rats and rabbits. Corticoid-induced ON: Rats were randomized into five groups. A negative control and four groups treated with prednisolone 6 mg/Kg: a positive control and three treated with D-003 (5, 25 and 200 mg/Kg) for 80 days. All positive controls presented ON areas. D-003 significantly reduced the numbers and proportions of ON lesions, as compared to the positive control group. LPS-induced ON in rabbits: Rabbits were randomized into five groups: a negative control and four injected with a single intra-venous injection of LPS (10 µg/Kg) including a positive control and three with D-003 (5, 25 and 200 mg/Kg) for 30 days. ON was seen in all positive controls. The incidence of ON and the number of ON lesions in the groups treated with D-003 (25 and 200 mg/Kg) was significantly lower compared to the positive controls. LPS injection significantly increased the size of bone marrow fat cells in positive controls and such increase was significantly decreased by D-003. In conclusion, D-003 reduced ON lesions in corticoid-and LPS-induced ON and also the size of bone marrow fat cells in rabbits with LPS.

Mapping the awareness of inequalities in health programs in Spanish communities: moving forward together.

The aim of this study is to map the awareness of gender, socioeconomic, immigrant and ethnic health inequalities in health at schools, maternal health and traffic injury health prevention programs. The study was conducted in the 19 health descentralized areas in Spain, 17 autonomous community (ACs) and the 2 autonomous cities (ACities). The data were collected from May 2008 to January 2009. The unit of analysis was the collection of policy documents setting out the programs mentioned above and the related support material in each AC. A reading guide was used to analyze the awareness of inequalities. With regard to health at schools, 2 of 10 programs show a high awareness of inequalities and include many specific proposals to be implemented at the local level. Regarding maternal health, 13 ACs have prepared support material with high awareness of inequalities to be implemented. A traffic injury program has been created in two ACs. We map the whole situation in Spain regarding the health programs that we have used as examples and their awareness of inequalities. We can conclude that there are differences between the regions studied in Spain and in general, the awareness of inequalities is low.