Viscum Album Lipophilic Extract in Actinic Keratosis, Cutaneous Squamous Cell Carcinoma, and Basal Cell Carcinoma: A Retrospective Case Series.

INTRODUCTION: Cutaneous squamous cell carcinoma (cSCC) and basal cell carcinoma (BCC) belong to the group of keratinocyte carcinomas (KC). Actinic keratosis (AK) is a precursor lesion of cSCC. The incidences of cSCC, BCC, and AK are currently strongly increasing. Different standard therapies exist for these conditions but are not always applicable or successful. Hydrophilic Viscum album extracts have been used in anthroposophic cancer therapy since 1917. Viscum album lipophilic extract (VALE) is prepared by means of supercritical CO2 extraction. This retrospective case series assessed the safety and clinical effects of a topical application of 10% VALE in individual cases of cSCC, BCC, and AK. METHODS: For this retrospective case series, a positive vote was obtained from the Ethics Committee of the University of Witten/Herdecke (No. 146/2020). Eligible patients signed a declaration of consent prior to inclusion in the study. The main outcome parameters were the clinical response to treatment with VALE and adverse drug reactions. Risk factors, concomitant therapies and diseases, further diagnostic and therapeutic information were documented where available. Data analysis was performed on the level of patients and of individual lesions. RESULTS: The study population consisted of 55 patients with 74 skin lesions. Individual case analysis accompanied by photographic documentation revealed typical and promising treatment courses. Clinical response rates (complete + partial remissions) for individual lesions were 78% for cSCC, 70% for BCC, and 71% for AK. Complete remission rates for individual lesions were 56% for cSCC, 35% for BCC, and 15% for AK. In cSCC and BCC, shorter times to best clinical response were observed. Adverse drug reactions were reported in 5 patients including erythema and inflammatory reactions of mostly moderate severity that resolved completely. In one case, therapy was temporarily paused, in four cases it was continued without interruption. DISCUSSION/CONCLUSION: The results of this study suggest that VALE is a safe and tolerable extract under whose application complete and partial remissions of KC could be observed. To improve and assess the efficacy of VALE, prospective investigations are necessary.Das kutane Plattenepithelkarzinom (cSCC) und das Basalzellkarzinom (BCC) gehören zur Gruppe der Keratinozytenkarzinome (KC). Die aktinische Keratose (AK) ist eine Vorstufe des cSCC. Die Häufigkeit von cSCC, BCC und AK ist derzeit stark im Steigen begriffen. Es gibt verschiedene Standardtherapien für diese Erkrankungen, die jedoch nicht immer anwendbar oder erfolgreich sind. Hydrophile Viscum album-Extrakte werden seit 1917 in der anthroposophischen Krebstherapie eingesetzt. Viscum album Lipophilic Extract (VALE) wird mittels überkritischer CO2-Extraktion hergestellt. In dieser retrospektiven Fallserie wurden die Sicherheit und die klinischen Auswirkungen einer topischen Anwendung von 10% VALE bei einzelnen Fällen von cSCC, BCC und AK untersucht.Für diese retrospektive Fallserie wurde ein positives Votum der Ethikkommission der Universität Witten/Herdecke eingeholt (Nr. 146/2020). Die in Frage kommenden Patienten unterzeichneten vor der Aufnahme in die Studie eine Einverständniserklärung. Die wichtigsten Ergebnisparameter waren das klinische Ansprechen auf die Behandlung mit VALE und unerwünschte Arzneimittelwirkungen. Risikofaktoren, Begleittherapien und -erkrankungen sowie weitere diagnostische und therapeutische Informationen wurden, soweit vorhanden, dokumentiert. Die Datenanalyse wurde für jeden einzelnen Patienten und jeder einzelnen Läsion durchgeführt.Die Studienpopulation bestand aus 55 Patienten mit 74 Hautläsionen. Die Einzelfallanalyse mit Fotodokumentation ergab typische und vielversprechende Behandlungsverläufe. Die klinischen Ansprechraten (vollständige + partielle Remissionen) für einzelne Läsionen lagen bei 78% für cSCC, 70% für BCC und 71% für AK. Die Komplettremissionsraten für einzelne Läsionen lagen bei 56% für cSCC, 35% für BCC und 15% für AK. Bei cSCC und BCC wurden kürzere Zeiten bis zum besten klinischen Ansprechen beobachtet. Bei fünf Patienten wurden unerwünschte Arzneimittelwirkungen gemeldet, darunter Erytheme und Entzündungsreaktionen von meist mäßigem Schweregrad, die vollständig abklangen. In einem Fall wurde die Therapie vorübergehend pausiert, in vier Fällen wurde sie ohne Unterbrechung fortgesetzt.Die Ergebnisse dieser Studie deuten darauf hin, dass VALE ein sicherer und verträglicher Extrakt ist, bei dessen Anwendung vollständige und partielle Remissionen von KC beobachtet werden konnten. Um die Wirksamkeit der Therapie mit VALE weiterzuentwickeln und eingehender zu beurteilen, sind prospektive Untersuchungen erforderlich.

Leaf surface features of maize cultivars and response to foliar phosphorus application: effect of leaf stage and plant phosphorus status.

Soil phosphorus (P) application is the most common fertilisation technique but may involve constraints due to chemical fixation and microbial immobilisation. Furthermore, excessive P fertilisation leads to P runoff into water bodies, threatening ecosystems, so targeted foliar P fertilisation is an interesting alternative. This study aimed to determine the importance of leaf surface characteristics for foliar P uptake in P-deficient maize (Zea mays L.). The leaf surface of four maize cultivars was characterised by electron microscopy, Fourier transform infrared spectroscopy and contact angle measurements. Uptake of foliar-applied P by maize cultivars was estimated, measuring also leaf photosynthetic rates after foliar P spraying. Plants of cultivar P7948 were found to be wettable from the 4th leaf in acropetal direction, whereas other cultivars were unwettable until the 6th leaf had developed. Minor variations in stomatal number and cuticle composition were recorded, but no differences in foliar P absorption were observed between cultivars. Nevertheless, cultivars showed variation in the improvement of photosynthetic capacity following foliar P application. Phosphorus deficiency resulted in ultrastructural disorganisation of mesophyll cells and chloroplasts, which impaired photosynthetic performance, yet there was no effect on stomatal frequency and leaf wettability. This study provides new insights into the influence of P deficiency and cultivar on leaf surface characteristics, foliar P uptake and its effect on physiological processes. Understanding the relationships between leaf characteristics and P uptake allows a more targeted evaluation of foliar P fertilisation as an application technique and contributes to the understanding of foliar uptake mechanisms.

Information technology and changing role models in German libraries: The example of OPEN-CAM.

Germany has a long tradition of health libraries. From their origin in monasteries, they became centres of knowledge and education. In modern times, this tradition has been continued by the Central Library of Medicine. In addition, as a specialty in Germany, special collection areas and special libraries that focus on one topic were established. Those services were transformed to specialized information services and portals as part of the digital transformation process. One of such projects is OPEN-CAM, which provides literature on integrative medicine in a specialist library and hosts the literature database CAMbase. Based on this example, we show how digital transformation has influenced the library landscape and its structures in Germany.

The Introspective Patient Experience of Mistletoe Therapy in Cancer: A Qualitative Study.

INTRODUCTION: The introspective experience of cancer patients using mistletoe therapy has received little scientific interest, although it is crucial for a holistic understanding of this therapy. This study contributes to patient-centered research and treatment by documenting the subjective experiences of individuals undergoing mistletoe therapy. METHODS: In this qualitative, explorative study, 20 outpatients with a history of various cancer types were recruited from Arlesheim Hospital (Arlesheim, Switzerland). All patients received subcutaneous mistletoe therapy for at least 2 years (median 7.5 years). Data was collected through 2 semi-structured, in-depth interviews per patient. Qualitative content analysis was applied to examine the data. The individual experience of mistletoe therapy was analyzed in relation to 6 predefined levels of human experience: physical, vital, emotional, mental, spiritual and social. In addition, 3 further aspects, considered as cross-dimensional perspectives, emerged out of the material: warmth, immune strengthening, and general wellbeing. RESULTS: Data analysis revealed considerable heterogeneity among patients' experiences with mistletoe therapy. The importance of specific aspects became apparent, such as increased vitality to manage daily life, greater emotional and mental stability, warmth as a multidimensional phenomenon, feelings of safety and protection through mistletoe therapy, heightened self-awareness and improved self-care, as well as sensations of spiritual connectedness. CONCLUSIONS: Prior to this study it had not been shown that cancer patients using mistletoe therapy do have observations on different levels of experience. These results may lead to a deeper understanding of patients receiving mistletoe therapy, enabling them to be supported in a more holistic way both during mistletoe treatment and on their life path. Further investigations into the effects of mistletoe therapy on the emotional, mental, and spiritual level are warranted.

Infigratinib, a selective FGFR1-3 tyrosine kinase inhibitor, alters dentoalveolar development at high doses.

BACKGROUND: Fibroblast growth factor receptor-3 (FGFR3) gain-of-function mutations are linked to achondroplasia. Infigratinib, a FGFR1-3 tyrosine kinase inhibitor, improves skeletal growth in an achondroplasia mouse model. FGFs and their receptors have critical roles in developing teeth, yet effects of infigratinib on tooth development have not been assessed. Dentoalveolar and craniofacial phenotype of Wistar rats dosed with low (0.1 mg/kg) and high (1.0 mg/kg) dose infigratinib were evaluated using micro-computed tomography, histology, and immunohistochemistry. RESULTS: Mandibular third molars were reduced in size and exhibited aberrant crown and root morphology in 100% of female rats and 80% of male rats at high doses. FGFR3 and FGF18 immunolocalization and extracellular matrix protein expression were unaffected, but cathepsin K (CTSK) was altered by infigratinib. Cranial vault bones exhibited alterations in dimension, volume, and density that were more pronounced in females. In both sexes, interfrontal sutures were significantly more patent with high dose vs vehicle. CONCLUSIONS: High dose infigratinib administered to rats during early stages affects dental and craniofacial development. Changes in CTSK from infigratinib in female rats suggest FGFR roles in bone homeostasis. While dental and craniofacial disruptions are not expected at therapeutic doses, our findings confirm the importance of dental monitoring in clinical studies.

The Effects of Anthroposophic Medicine in Chronic Pain Conditions: A Systematic Review.

Background: The currently available evidence is unclear in regard to pain-related outcomes of patients with chronic pain conditions who undergo treatment with anthroposophic medicine (AM). Aim: To identify and synthesize the evidence in patients with chronic pain before and after AM therapy. Methods: The following databases and search interfaces were searched on October 21, 2021: Embase (via Embase.com), Medline (via PubMed), and the Cochrane Library. Additional references were identified via bibliographies of included studies. In at least one experimental arm that used anthroposophic therapy to treat chronic pain, AM treatments were required to be documented. Included studies reported on pain severity and physical and emotional functioning. Two authors independently assessed the studies for inclusion criteria, extracted the data, and conducted the quality evaluation of the included studies based on the critical appraisal tools provided by the Joanna Briggs Institute. Results: Seven studies (eight publications) were included in the review, of which were three randomized controlled trials (RCTs), two non-RCTs, and two pretest-post-test studies. A total number of 600 patients participated in the identified experimental studies, of whom all were adults. Three studies included patients with low back pain, one study each assessed patients with fibromyalgia, migraine, dysmenorrhea, and postpolio syndrome, respectively. The identified clinical studies reported considerable reductions in symptoms and effect sizes of pain outcomes after AM therapies being predominantly large, with no notable adverse effects. Conclusion: The findings of this systematic review of studies assessing AM therapies in patients with chronic pain problems revealed that there is a scarcity of evidence currently available, with unclear effects of AM treatments in reducing pain intensity and improving quality of life in the evaluated health conditions. Although most of the studies revealed a favorable benefit on one or more pain-related outcomes, the variability of the research did not allow for generalization across different studies, health conditions, and populations.

Update of the consensus document on the aetiology, diagnosis and treatment of acute otitis media and sinusitis.

Update of the consensus on acute otitis media (AOM) (2012) and sinusitis (2013) following the introduction of pneumococcal vaccines in the immunization schedule, and related changes, such as epidemiological variation, colonization by of nonvaccine serotypes and emerging antimicrobial resistances. A majority of studies show that the introduction of the pneumococcal 13-valent conjugate vaccine has been followed by a reduction in the nasopharyngeal carriage of pneumococcus, with an increase in the proportion of drug-resistant nonvaccine serotypes. The diagnosis of AOM is still clinical, although more stringent criteria are proposed, which are based on the visualization of abnormalities in the tympanic membrane and the findings of pneumatic otoscopy performed by trained clinicians. The routine diagnosis of sinusitis is also clinical, and the use of imaging is restricted to the assessment of complications. Analgesia with acetaminophen or ibuprofen is the cornerstone of AOM management; watchful waiting or delayed antibiotic prescription may be suitable strategies in select patients. The first-line antibiotic drug in children with AOM and sinusitis and moderate to severe disease is still high-dose amoxicillin, or amoxicillin-clavulanic acid in select cases. Short-course regimens lasting 5-7 days are recommended for patients with uncomplicated disease, no risk factors and a mild presentation. In allergic patients, the selection of the antibiotic agent must be individualized based on severity and whether or not the allergy is IgE-mediated. In recurrent AOM, the choice between watchful waiting, antibiotic prophylaxis or surgery must be individualized based on the clinical characteristics of the patient.

Bending Enamine Patterns of Stabilized Pentalenes into "Polymethine Ylides".

We report the synthesis and structural study of 2-substituted 1,3-bis(dimethylamino)pentalenes. The two electrons donating substituents shift the formally anti-aromatic pattern toward more suitable polarized structures. A subtle steric trade-off can result either in planar cyclopentadienyl vinamidiniums or in distorted structures featuring a pyramidalized ylidic carbon adjacent to a stabilized π-conjugated iminium (polymethine). This latter pattern mimics a postulated activated distorted geometry for key Breslow intermediates in the active site of thiamine-dependent enzymes. It highlights how the energetic drive to avoid anti-aromaticity can be used to access models for unconventional distorted conformations of organic molecules.

Hydrotherapeutic Heat Application as Support in Febrile Patients: A Scoping Review.

Background: Most often, fever is still treated by lowering body temperature with medication. In complementary and integrative health care, patients are supported during illness to use the positive effects of fever. Accompanying applications from the field of hydrotherapy are often used for gentle cooling, but there are references that warming in fever can also be used as a support. The aim of this scoping review was to identify available evidence on how, when, and why patients with fever are treated with heat application. Methods: The MEDLINE, CINAHL, EMBASE, COCHRANE, Google, and Google Scholar databases as well as references of identified literature were searched. As sources of evidence, publications studying patients who received heat application or were kept warm in febrile condition, regardless of medical situation, type of health care setting, and geographical background, were taken into consideration. Results: The literature search identified 1698 publications, of which only 7 were included. Methods of applying heat were the use of electric warming blankets, hot packs, hot-water bottles, or hot water footbaths. Most of the studies on heat application used temperatures of about 40°C and reported significantly lower body temperature after heat application. Conclusions: The literature suggests that hydrotherapeutic heat application is a common and well-appreciated method in Middle Eastern and Asian regions to support febrile patients. Using heat to support the energy-intensive and uncomfortable phase of rising fever may improve comfort, prevent unnecessarily high fever, and save biological energy. Therefore, high-quality studies on the role of heat application in fever are expected to be of high relevance for future fever management guidelines and integrative health care in general.

Integrative medicine during the intensive phase of chemotherapy in pediatric oncology in Germany: a randomized controlled trial with 5-year follow up.

BACKGROUND: Integrative medicine is used frequently alongside chemotherapy treatment in pediatric oncology, but little is known about the influence on toxicity. This German, multi-center, open-label, randomized controlled trial assessed the effects of complementary treatments on toxicity related to intensive-phase chemotherapy treatment in children aged 1-18 with the primary outcome of the toxicity sum score. Secondary outcomes were chemotherapy-related toxicity, overall and event-free survival after 5 years in study patients. METHODS: Intervention and control were given standard chemotherapy according to malignancy & tumor type. The intervention arm was provided with anthroposophic supportive treatment (AST); given as anthroposophic base medication (AMP), as a base medication for all patients and additional on-demand treatment tailored to the intervention malignancy groups. The control was given no AMP. The toxicity sum score (TSS) was assessed using NCI-CTC scales. RESULTS: Data of 288 patients could be analyzed. Analysis did not reveal any statistically significant differences between the AST and the control group for the primary endpoint or the toxicity measures (secondary endpoints). Furthermore, groups did not differ significantly in the five-year overall and event-free survival follow up. DISCUSSION: In this trial findings showed that AST was able to be safely administered in a clinical setting, although no beneficial effects of AST between group toxicity scores, overall or event-free survival were shown.

Cancer-related fatigue in patients treated with mistletoe extracts: a systematic review and meta-analysis.

PURPOSE: Cancer-related fatigue remains one of the most prevalent and distressing symptoms experienced by cancer patients. Effective treatments for cancer-related fatigue are needed. The objective of this meta-analysis is to determine the impact of mistletoe extracts as a pharmacological treatment for the management of cancer-related fatigue. METHODS: We included randomized clinical trials (RCTs) and non-randomized studies of interventions (NRSIs) in cancer patients. Inclusion criteria were cancer-related fatigue severity or prevalence as an outcome and testing of mistletoe extracts compared to control groups. We searched Medline (EuropePMC), Embase, the Cochrane Central Register of Controlled Trials, Clinicaltrials.gov, and opengrey.org through October 2020. We assessed the risk of bias using the Cochrane risk of bias tools for RCTs and NRSIs and conducted a meta-analysis. RESULTS: We performed one meta-analysis with 12 RCTs, including 1494 participants, and one meta-analysis with seven retrospective NRSIs, including 2668 participants. Heterogeneity between the studies was high in both meta-analyses. Most studies had a high risk of bias. A random-effects model showed for RCTs a standardized mean difference of -0.48 (95% confidence interval -0.82 to -0.14; p = 0.006) and for NRSIs an odds ratio of 0.36 (95% confidence interval 0.20 to 0.66; p = 0.0008). CONCLUSION: Treatment with mistletoe extracts shows a moderate effect on cancer-related fatigue of similar size to physical activity. These results need to be confirmed by more placebo-controlled trials. Future trials should investigate different treatment durations and their effect on cancer-related fatigue in post-treatment cancer survivors. TRIAL REGISTRATION: This meta-analysis has been registered under the PROSPERO registration number CRD42020191967 on October 7, 2020.

Critical Evaluation of Specific Efficacy of Preparations Produced According to European Pharmacopeia Monograph 2371.

European Pharmacopoeia monograph 2371 describes the production of homeopathic preparations. A specific efficacy of these preparations in high dilution levels is questionable in view of basic scientific principles. There is empirical evidence for such effects, for example in a Lemna-intoxication bioassay published 2010. To test the replicability and robustness of this bioassay, we conducted two experimental series (five independent blinded and randomised experiments each). The specimen of Lemna gibba L., clone-number 9352, were stressed in arsenic solution for 48 h (158 mg/L AsNa2HO4 (250 mg/L in series 2)), then grew in either As2O3 preparations produced according to Eu. Pharm. Monogr. 2371 or control solution. Comparing the area-related relative growth rate of day 3−9 (rgr 3−9) between treatment and control groups for each series showed differences that were not significant in series 1 (p = 0.10), significant in series 2 (p = 0.04) and significant in the pooled data of both series (p < 0.01). The effect direction (rgr 3−9 increase) was comparable to experiments of 2010, but the effect size was smaller, likely due to a changed light cycle. These results are not compatible with the hypothesis that the application of European Pharmacopoeia monograph 2371 results in pharmaceutical preparations without specific effects. Further studies are needed to investigate a potential mode of action explaining these effects.

Hypericum perforatum to Improve Postoperative Pain Outcome After Monosegmental Spinal Sequestrectomy (HYPOS): Results of a Randomized, Double-Blind, Placebo-Controlled Trial.

Introduction: Patients undergoing lumbar spine surgery often suffer from severe radicular postoperative pain leading to the prescription of high-dose opioids. In Integrative Medicine, Hypericum perforatum is known as a remedy to relieve pain caused by nerve damage. Objectives: This trial investigated whether homeopathic Hypericum leads to a reduction in postoperative pain and a decrease in pain medication compared with placebo. Design: Randomized double blind, monocentric, placebo controlled clinical trial. Settings/Location: Department of Neurosurgery, Community Hospital Herdecke. Subjects: Inpatients undergoing lumbar sequestrectomy surgery. Interventions: Homeopathic treatment versus placebo in addition to usual pain management. Outcomes Measures: Primary endpoint was pain relief measured with a visual analog scale. Secondary endpoints were the reduction of inpatient postoperative analgesic medication and change in sensory and affective pain perception. Results: Baseline characteristics were comparable between the groups. Pain perception between baseline and day 3 did not significantly differ between the study arms. With respect to pain medication, total morphine equivalent doses did not differ significantly. However, a statistical trend and a moderate effect (d = 0.432) in the decrease of pain medication consumption in favor of the Hypericum group was observed. Conclusion: This is the first trial of homeopathy that evaluated the efficacy of Hypericum C200 after lumbar monosegmental spinal sequestrectomy. Although no significant differences between the groups could be shown, we found that patients who took potentiated Hypericum in addition to usual pain management showed lower consumption of analgesics. Further investigations, especially with regard to pain medication, should follow to better classify the described analgesic reduction. Clinical Trial Registration Number: German Clinical Trials Register No: DRKS00007913.

Oxidative and glycolytic skeletal muscles deploy protective mechanisms to avoid atrophy under pathophysiological iron overload.

BACKGROUND: Iron excess has been proposed as an essential factor in skeletal muscle wasting. Studies have reported correlations between muscle iron accumulation and atrophy, either through ageing or by using experimental models of secondary iron overload. However, iron treatments performed in most of these studies induced an extra-pathophysiological iron overload, more representative of intoxication or poisoning. The main objective of this study was to determine the impact of iron excess closer to pathophysiological conditions on structural and metabolic adaptations (i) in differentiated myotubes and (ii) in skeletal muscle exhibiting oxidative (i.e. the soleus) or glycolytic (i.e. the gastrocnemius) metabolic phenotypes. METHODS: The impact of iron excess was assessed in both in vitro and in vivo models. Murine differentiated myotubes were exposed to ferric ammonium citrate (FAC) (i.e. 10 and 50 µM) for the in vitro component. The in vivo model was achieved by a single iron dextran subcutaneous injection (1 g/kg) in mice. Four months after the injection, soleus and gastrocnemius muscles were harvested for analysis. RESULTS: In vitro, iron exposure caused dose-dependent increases of iron storage protein ferritin (P < 0.01) and dose-dependent decreases of mRNA TfR1 levels (P < 0.001), which support cellular adaptations to iron excess. Extra-physiological iron treatment (50 µM FAC) promoted myotube atrophy (P = 0.018), whereas myotube size remained unchanged under pathophysiological treatment (10 µM FAC). FAC treatments, whatever the doses tested, did not affect the expression of proteolytic markers (i.e. NF-κB, MurF1, and ubiquitinated proteins). In vivo, basal iron content and mRNA TfR1 levels were significantly higher in the soleus compared with the gastrocnemius (+130% and +127%; P < 0.001, respectively), supporting higher iron needs in oxidative skeletal muscle. Iron supplementation induced muscle iron accumulation in the soleus and gastrocnemius muscles (+79%, P < 0.001 and +34%, P = 0.002, respectively), but ferritin protein expression only increased in the gastrocnemius (+36%, P = 0.06). Despite iron accumulation, muscle weight, fibre diameter, and myosin heavy chain distribution remained unchanged in either skeletal muscle. CONCLUSIONS: Together, these data support that under pathophysiological conditions, skeletal muscle can protect itself from the related deleterious effects of excess iron.

Use of a mobile app to capture supplemental health information during pregnancy: Implications for clinical research.

PURPOSE: Mobile applications ("apps") may be efficient tools for improving the quality of clinical research among pregnant women, but evidence is sparse. We assess the feasibility and generalizability of a mobile app for capturing supplemental data during pregnancy. METHODS: In 2017, we conducted a pilot study of the FDA MyStudies mobile app within a pregnant population identified through Kaiser Permanente Washington (KPWA), an integrated healthcare delivery system. We ascertained health conditions, medications, and substance use through app-based questionnaires. In a post-hoc analysis, we utilized electronic health records (EHR) to summarize sociodemographic and health characteristics of pilot participants and, for comparison, a pregnant population identified using similar methods. RESULTS: Six percent (64/1070) of contacted women enrolled in the pilot study. Nearly half (23/53) reported taking medication for headaches and one-fourth for constipation (13/53) and nausea (12/53) each. Few instances (2/92) of over-the-counter medication use were identified in electronic dispensing records. One-quarter to one-third of participants with depression and anxiety/panic, respectively, reported recently discontinuing medications for these conditions. Eighty-eight percent of pilot participants reported White race (95%CI: 81-95%), versus 67% of the comparison population (N = 2065). More pilot participants filled ≥1 prescription for antianxiety medication (22% [95%CI: 13-35%]) and antidepressants (19% [95%CI 10-31%]) pre-pregnancy than the comparison population (10 and 9%, respectively). CONCLUSIONS: Mobile apps may be a feasible tool for capturing health data not routinely available in EHR. Pregnant women willing to use a mobile app for research may differ from the general pregnant population, but confirmation is needed.

In vitro evaluation of the anti-pathogenic activity of Okoubaka aubrevillei on the human gastrointestinal tract.

BACKGROUND: Okoubaka aubrevillei is used in traditional West African medicine and in homeopathy for treatment and prevention of several gastrointestinal problems. The aim of this in vitro study was to evaluate the effect of repeated doses of two Okoubaka products (10 % ethanolic tincture, mother tincture (MT); 3rd decimal potency, 3X) on the microbial activity of physiological human colon microbiota using a Simulator of the Human Intestinal Microbial Ecosystem (SHIME®) and to investigate any preventive effect against infections with diarrhea-causing pathogens. METHODS: Upon inoculation with fecal microbiota from a healthy donor, 4 parallel proximal colon compartments of the SHIME were treated either with Okoubaka MT, Okoubaka 3X, ethanol control or blank control for 7 days. Using the Okoubaka-adapted microbial community from SHIME, 48 h challenge tests were performed with enterotoxigenic Escherichia coli (ETEC) and Salmonella enteritidis in 4 different doses (103-108 colony forming units as typical in vivo infectious doses). Pathogen concentrations, short-chain fatty acids (SCFAs) and branched SCFA production were measured in triplicate at 0, 24 and 48 h. RESULTS: In the challenge tests, both Okoubaka products were able to restrict the colonization of ETEC and Salmonella at 3 of the 4 pathogen doses (except the highest doses), with a stronger anti-pathogenic effect for MT, which included a reduction of 2.0 log-units of ETEC (p < 0.0001) and 1.1 log-units of Salmonella (p < 0.0001). Total SCFA levels remained unaffected, but butyrate increased during the first 24 h (p < 0.0001 for ETEC), accompanied by decreased acetate production. CONCLUSION: We observed in vitro a systemic activating effect of Okoubaka on intestinal microbiome resistance, which resulted in an anti-pathogenic effect, especially against ETEC. We hypothesize that the mode of action in vivo is also based on systemic regulative effects.

Alterations in atrial electrogram amplitude as steady sinus rhythm transitions to paroxysmal atrial fibrillation during continuous monitoring in patients with implantable cardiac devices: Insights from the IMPACT study.

OBJECTIVES: We aimed to evaluate whether device measured amplitudes of atrial electrogram (AEGM) would change when measured in sinus rhythm (SR) transitioning to paroxysmal atrial fibrillation (AF) from previous steady SR, and significance of such change. METHODS: From the IMPACT trial's database we selected two groups; (A) those who developed AF (n = 164), and (B) propensity-matched control (n = 459) who stayed in SR during continuous Home Monitoring (HM) to compare AEGMs amplitudes at baseline SR and transition phase. RESULTS: During 420.0 ± 349.2 days (mean ± SD) from first postenrollment HM transmission to AF event transmission in Group A, and corresponding 515.3 ± 407.0 days in Group B, baseline and transition AEGM amplitude were 2.88 ± 1.146 and 2.74 ± 1.186 mV, respectively, for Group A (p = .1), and 2.88 ± 1.155 and 2.79 ± 1.145, respectively, for Group B (p < .005). Comparison of differences of AEGM amplitude, 0.14 ± 1.072 mV in Group A and 0.09 ± 0.893 mV in Group B were insignificant (p = .3). Age, sex, and hypertension identified as confounders had no association to AEGM changes (p = NS). CONCLUSIONS: Independent of age, sex, and hypertension, AEGMs amplitudes decline over a long period of time in patients with defibrillators and substrate for AF. The significance of such change remains unclear as it occurs whether patients develop AF or not, but raises a possibility of progressive atrial myopathy that patients with substrate for AF may be predisposed to.

[A real-world study to evaluate a peptidic oral supplement in adults with altered intestinal function after parenteral nutrition]. / Un estudio en la vida real para evaluar un suplemento oral peptídico en adultos con alteración de la función intestinal tras la nutrición parenteral.

INTRODUCTION: Objectives: in routine clinical practice many disorders are found that can disrupt the sequence of reactions in digestion and absorption, leading to malnutrition and requiring the use of oral nutritional supplements (ONS). The objective of our study was to evaluate in a real world setting the use of and compliance with a peptide-based ONS in malnourished adult patients with intestinal compromise after more than 14 days of parenteral nutrition. Material and methods: the study was carried out in 44 malnourished patients who required total parenteral nutrition for at least 14 days without using the oral route during their hospital stay. All patients were administered, on an outpatient basis, 1 brick per day of Vital 1.5® for 12 weeks. At the beginning of treatment and after the intervention period evaluated, the following variables were collected: weight, height, body mass index (BMI), global subjective assessment test, nutritional biochemistry, 3-day nutritional survey, adverse effects generated by the formula, and completion rate. Results: 44 patients were enrolled. Mean age was 70.4 ± 10.4 years (20 women & 24 men). After the intervention the following parameters had increased: BMI (0.51 ± 0.1 kg/m2; p = 0.02), weight (1.4 ± 0.3 kg; p = 0.03), prealbumin (3.5 ± 4.1 mg/dl; p = 0.01), albumin (1.3 ± 0.1 mg/dl; p = 0.03), and transferrin (71.5 ± 24.1 mg/dl; p = 0.02). Dietary intake of the ONS represented 14.4 % of the diet's total caloric intake at 3 months, 17.5 % of carbohydrates, 12.9 % of proteins, and 12.3 % of fats. Mean compliance was 87.7 ± 7.2 % of the prescribed intakes. In relation to the nutritional situation, at the beginning of the study, 52.3 % (n = 23) of patients were in the global subjective assessment test in category B (moderate malnutrition or nutritional risk), and 47.7 % (n = 21) in category C (severe malnutrition). After the intervention, 75 % of patients were in category A (n = 33), 13.6 % (n = 6) in category B, and 11.4 % (n = 5) in category C. Conclusions: the use of a peptide-based ONS with short-chain triglycerides in outpatients showed a beneficial effect on biochemical and anthropometric parameters, and improved the nutritional status of patients with high compliance and good tolerance rates.

INTRODUCCIÓN: Objetivos: en la práctica clínica habitual existen multitud de situaciones y patologías que pueden interrumpir la digestión y la absorción intestinal, cursando con desnutrición y requiriendo el uso de suplementos orales nutricionales (SON). El objetivo de nuestro estudio fue evaluar, en el contexto de la vida real, el uso de un SON basado en péptidos, y el cumplimiento con el mismo, en pacientes adultos desnutridos con compromiso intestinal tras más de 14 días de nutrición parenteral. Material y métodos: el estudio se realizó en 44 pacientes desnutridos que requirieron nutrición parenteral total al menos 14 días, sin utilización de la vía oral durante el ingreso hospitalario. Se les administró de manera ambulatoria 1 brik al día de Vital 1.5® para su consumo durante 12 semanas. Al inicio del tratamiento y tras el periodo de intervención se les recogieron las variables siguientes: peso, talla, IMC, test de valoración subjetiva global, bioquímica nutricional, encuesta nutricional, efectos adversos generados por la fórmula y cumplimentación. Resultados: se incluyeron 44 pacientes con una edad media de 70,4 ± 10,4 años (20 mujeres/24 hombres). Tras la intervención aumentaron el IMC (0,51 ± 0,1 kg/m2; p = 0,02), el peso (1,4 ± 0,3 kg; p = 0,03), la prealbúmina (3,5 ± 4,1 mg/dl; p = 0,01), la albúmina (1,3 ± 0,1 mg/dl; p = 0,03) y la transferrina (71,5 ± 24,1 mg/dl; p = 0,02). La toma del SON represento a los 3 meses un 14,4 % del aporte calórico total de la dieta, un 17,5 % de los hidratos de carbono, un 12,9 % de las proteínas y un 12,3 % de las grasas. La cumplimentación media del grupo fue del 87,7 ± 7,2 % de las tomas prescritas. En relacion a la situacion nutricional, a la entrada del estudio un 52,3 % (n = 23) de los pacientes presentaban en el test de valoración subjetiva global la categoría B (malnutrición moderada o riesgo nutricional) y un 47,7 % (n = 21) la categoría C (desnutrición severa). Tras la intervención, un 75 % de los pacientes presentaban la categoría A (buena situación nutricional (n = 33), un 13,6 % (n = 6) de los pacientes presentaban la categoría B y un 11,4 % (n = 5) la categoría C. Conclusiones: la utilización de un suplemento peptídico con triglicéridos de cadena corta en pacientes ambulatorios tras haber recibido una nutrición parenteral total muestra un efecto beneficioso sobre los parametros bioquímicos y antropométricos, y la situación nutricional, con una alta cumplimentación y buena tolerancia.

Multi-criteria assessment of the viability of valorising vegetable by-products from the distribution as secondary raw material for animal feed.

Approximately 33% of food produced around the world is wasted. In the distribution sector, erroneous orders or demand predictions result in products that cannot be sold before the expiration date. Despite its enormous potential, a low percentage of this food wastage is valorised causing negative social, economic and environmental impacts. Vegetable food waste has potential as raw material for animal feed. However, the profitability of its valorisation depends on several key factors and there is a risk of underestimating any of them making this valorisation technically, economically or environmentally unfeasible. Moreover, the geographical dispersion requires selecting the appropriate location for the processing plant and optimising the logistics routes to collect and transport them from the origin points to the processing plant. GISWASTE tool, which combines Analytic Hierarchy Process (AHP) method with ArcGIS, has been used to simulate the viability of this valorisation alternative from a holistic point of view. In addition, a sensitivity analysis in the economic modelling has been carried out to determine the economic viability factors with more influence in the global profitability. The valorisation of vegetable food waste from distribution and retailing sector for animal feed has been considered feasible in the case study region: Basque Country (Spain). However, there are some economic uncertainties for the return of the investment. The variable with more influence over the profitability is by far the incomes from waste management (81.4%).