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Abstract Background Paediatric oncology/haematology patients and their families are confronted with a life-threatening situation for which music therapy can be a cross-linguistic field of action. The creative act of making music together offers the possibility to strengthen competences and make conflicts tangible. Besides its complementing of evidence-based biomedical care, there is little research on the feasibility and efficacy of interactive music therapy including the diagnosed child and their significant others. Methods We conducted an assessor blind, prospective, multicentric feasibility randomized controlled trial (RCT) with subsequent intervention. Including overall 52 child-significant other dyads, INMUT investigates interaction-focused music therapy with cancer-affected children and their significant others (INMUT-KB; n = 21) compared to music therapy only with the child (MUT-K; n = 21) and a wait-list group (WLG; n = 10). The measurement points include the screening for a cancer diagnosis, psychometric baseline (pre-T1), initial assessment (T1/T2), music therapy sessions (T3–T9), final assessment (T10), final psychometric evaluation (post-T10), and 3-month follow-up (cat-T11). Feasibility and acceptability of the (1) research methodology, (2) intervention and (3) estimation of effect sizes will be assessed using qualitative and quantitative data. The proposed primary outcome includes the parent–child interaction (APCI), and the proposed secondary outcomes refer to subjective goal achievement (GAS), quality of life (KINDL), system-related functional level (EXIS), psychosocial stress (BAS), psychosomatic complaints (SCL-9k), and resources (WIRF). We plan to investigate the efficacy of INMUT-KB and MUT-K post-intervention (post-T10) within the RCT design and at 3-month follow-up (cat-T11). Discussion This study will provide insights into the feasibility of INMUT and the final sample needed for a confirmatory RCT. We will reflect on successfully implemented study procedures and, if necessary, provide recommendations for changes considering the design, procedures, measures, and statistical analyses. The discussion will conclude with an evaluation whether a confirmatory RCT is worth the investment of future resources, including the calculated number of child-significant other dyads needed based on the efficacy trends derived from this feasibility study. Trial registration ClinicalTrials.gov: NCT05534282; date of registration: June 23, 2022.

Abstract Associations between depressive symptoms and breastfeeding are well documented. However, evidence is lacking for subdivisions of feeding styles, namely exclusive breastfeeding, exclusive formula feeding and a mixed feeding style (breastfeeding and formula feeding). In addition, studies examining associations between mother-child-bonding and breastfeeding have yielded mixed results. The aim of this study is to provide a more profound understanding of the different feeding styles and their associations with maternal mental health and mother-child-bonding. Data from 307 women were collected longitudinally in person (prenatally) and by telephone (3 months postnatally) using validated self-report measures, and analyzed using correlational analyses, unpaired group comparisons and regression analyses. Our results from a multinomial regression analysis revealed that impaired mother-child-bonding was positively associated with mixed feeding style (p = .003) and depressive symptoms prenatal were positively associated with exclusive formula feeding (p = .013). Further studies could investigate whether information about the underlying reasons we found for mixed feeding, such as insufficient weight gain of the child or the feeling that the child is unsatiated, could help prevent impaired mother-child-bonding. Overall, the results of this study have promising new implications for research and practice, regarding at-risk populations and implications for preventive measures regarding postpartum depression and an impaired mother-child-bonding.

Objective: Even though several German children’s hospitals offer integrative, anthroposophic medical therapies in addition to the standard medical care, guidelines for these anthroposophic therapies are still rare. Therefore, we investigated the feasibility of implementing a published, consensus-based guideline for the treatment of children with acute gastroenteritis (aGE) with anthroposophic therapies in the community hospital Herdecke. Design: A prospective case series of paediatric patients (≤18 years) with an aGE admitted to the department of integrative paediatrics of the community hospital Herdecke was conducted. Demographic, clinical and therapeutic data was recorded at initial presentation and at follow-up visits. Physicians were surveyed with a questionnaire to evaluate feasibility of implementing the guideline. Results: Sixty-two patients (0–15 years; 22 male, 40 female) were included in the case series. All patients received some form of anthroposophic therapy. The most frequently used remedies were Geum urbanum, Nux vomica and Bolus alba comp. Treating physicians showed a high adherence to the expert-based consensus guideline in their prescribed therapies. All physicians stated that they were familiar with the guideline and used the recommendation to inform their therapy decision. Suitability for daily use and effectiveness in treating the main symptoms of aGE were highly scored by the physicians. Conclusion: The consensus-based guideline of anthroposophic therapies for aGE in children was successfully implemented and found to be useful for physicians in clinical practice.

Background: Medical guidelines are an important basis for qualitative and cost-effective patient care. However, there is a lack of clinical recommendations in anthroposophic medicine (AM), an integrative medicine approach frequently practised in Europe. Acute tonsillitis, which includes tonsillopharyngitis, is a common childhood disease. that is mostly caused by a viral infection. Symptomatic treatment is therefore of high importance, and AM can offer several therapy options. Methods: 53 physicians from Germany, Spain, Netherlands, Switzerland, Austria, and Hungary with at least one year of experience in anthroposophic paediatric medicine were invited to participate in an online Delphi process. The process comprises five survey rounds starting with open-ended questions and ending with final statements, which need 75% agreement of experts to reach consensus. Expert answers were evaluated by two independent reviewers using MAXQDA and Excel. Results: Response rate was between 28% and 45%. The developed recommendation included 15 subtopics. These covered clinical, diagnostic, therapeutic and psychosocial aspects of acute tonsillitis. Six subtopics achieved a high consensus (>90%) and nine subtopics achieved consensus (75–90%). Conclusion: The clinical recommendation for acute tonsillitis in children aims to simplify everyday patient care and provide decision-making support when considering and prescribing anthroposophic therapies. Moreover, the recommendation makes AM more transparent for physicians, parents, and maybe political stakeholders as well.

Background: With increased life expectancy, the coexistence of functional impairment and multimorbidity can negatively impact life quality and coherence in geriatric individuals. The self-report 10-item Internal Coherence (ICS) measures how individuals cope with and make sense of disease-specific life challenges. The aim of this study was to validate the ICS in a sample of geriatric individuals. Methods and Procedure: In a cross-sectional study, geriatric individuals with and without chronic diseases were recruited. A factor analysis with principal component extraction (PCA) and a structural equation model (SEM) was conducted to assess the ICS factor structure in a geriatric sample. To measure convergent validity, the following scales were used: Short Health Survey (SF-12), Karnofsky Performance Index (KPI), Trait autonomic regulation (Trait aR), Sense of Coherence Scale (SOC), and Geriatric Depression Scale (GDS). Results: A sample of n = 104 (70–96 years of age) patients with Diabetes Mellitus Type 2 (n = 22), cancer diseases (n = 31) and healthy controls (n = 51) completed the ICS. PCA and SEM yielded the original two-factor solution: 1. Inner resilience and coherence and 2. Thermo coherence. Overall internal consistency for this cohort was satisfying (Cronbach’s α with rα = 0.72), and test-retest reliability was moderate (rrt = 0.53). ICS scores were significantly correlated to all convergent criteria ranging between r = 0.22 * and 0.49 ** (p < 0.05 *; p < 0.01 **). Conclusion: Study results suggest that the ICS appears to be a reliable and valid tool to measure internal coherence in a geriatric cohort (70–96 years). However, moderate test-retest reliability prompts the consideration of potential age-effects that may bias the reliability for this specific cohort.

Measurement(s) COVID-19 Protocols, Restrictions • Health Behaviors • Personality and Behavioral Change, CTCAE • Emotion • Message Framing • Self-Determination Technology Type(s) Survey • Experiment Design Type Factor Type(s) COVID-19 Protocols, Restrictions • Health Behaviors • Loss-Gain Framing • Cognitive Reappraisal • Self-Determination Messaging Sample Characteristic - Organism Homo Sample Characteristic - Environment Daily Life Sample Characteristic - Location North America • South America • Africa • Australia • Europe • United Kingdom • Asia

The regenerative capacity of well-preserved blood clots may be enhanced by biologics like enamel matrix derivative (EMD). This retrospective analysis compares outcomes reported by three centers using different heterografts. Center 1 (C1) treated intrabony defects combining cross-linked high-molecular-weight hyaluronic acid (xHyA) with a xenograft; center 2 (C2) used EMD with an allograft combination to graft a residual pocket. Center 3 (C3) combined xHyA with the placement of a resorbable polymer membrane for defect cover. Clinical parameters, BoP reduction, and radiographically observed defect fill at 12-month examination are reported. The 12-month evaluation yielded significant improvements in PPD and CAL at each center (p < 0.001, respectively). Analyses of Covariance revealed significant improvements in all parameters, and a significantly greater CAL gain was revealed for C2 vs. C1 (p = 0.006). Radiographic defect fill presented significantly higher scores for C2 and C3 vs. C1 (p = 0.003 and = 0.014; C2 vs. C3 p = 1.00). Gingival recession increased in C1 and C3 (p = 1.00), while C2 reported no GR after 12 months (C2:C1 p = 0.002; C2:C3 p = 0.005). BoP tendency and pocket closure rate shared similar rates. Within the limitations of the study, a data comparison indicated that xHyA showed a similar capacity to enhance the regenerative response, as known for EMD. Radiographic follow-up underlined xHyA’s unique role in new attachment formation.

The idea of artificially created social robots has a long tradition. Today, attitudes towards robots play a central role in the field of healthcare. Our research aimed to develop a scale to measure attitudes towards robots. The survey consisted of nine questions on attitudes towards robots, sociodemographic questions, the SWOP-K9, measuring self-efficacy, optimism, and pessimism, and the BFI-10, measuring personality dimensions. Structural relations between the items were detected using principal components analysis (PCA) with Varimax rotation. Correlations and Analysis of Variance were used for external validation. In total, 214 participants (56.1% female, mean age: 30.8 ± 14.4 years) completed the survey. The PCA found two main components, “Robot as a helper and assistant” (RoHeA) and “Robot as an equal partner” (RoEqP), with four items each explaining 53.2% and 17.5% of the variance with a Cronbach’s α of 0.915 and 0.768. In the personality traits, “Conscientiousness” correlated weakly with both subscales and “Extraversion” correlated with RoHeA, while none the subscales of the SWOP-K9 significantly correlated with RoEqP or RoHeA. Male participants scored significantly higher than female participants. Our survey yielded a stable and convergent two-factor instrument that exhibited convincing validity and complements other findings in the field. The ASRS can easily be used to describe attitudes towards social robots in human society. Further research, however, should be carried out to investigate the discriminant and convergent validity of the ASRS.

BackgroundMental disorders are most common causes of illness worldwide. Studies on art and drawing tasks, such as the tree-drawing test have already proven their prognostic quality for the diagnosis of Alzheimer’s disease, depression or trauma. In the depiction of art in public space, gardens and landscapes are one of the oldest human forms of artistic expression. This study thus aims at exploring the impact of a landscape design task as a prognostic tool to detect mental burden.Materials and methodsA total of 15 individuals (eight female) aged between 19 and 60 years completed the Brief Symptom Inventory BSI-18 and the State Trait Anxiety Inventory (STAI-S) before being asked to design a landscape in a 3 × 3 m squared area. Material to be used included plants, flowers, branches, and stones. The complete process of landscape design was videotaped and the tapes were analyzed in a two-step focus group analysis from a group of gardening trainees, psychology students and students of arts therapies. Results were condensed in a second step into major categories.ResultsScores of the BSI-18 showed a range of 2–21 points and STAI-S scores ranged between 29 and 54 points indicating a light to moderate mental burden. Focus group participants identified three mutually perpendicular major components associated with mental health: “Movement and Activity,” “Material Selection and Design,” and “Connectedness to the task.” In a subsample of the three least and three most mentally stressed subjects (based on their GSI and STAI-S scorings), clear differences were found in body posture, action planning and the choice of material and aspects of design.DiscussionIn addition to the well-known therapeutic potential of gardening, this study for the first time showed that gardening and landscape design contains diagnostic elements. Our preliminary findings are in coherence with similar research indicating a high association of movement and design patterns with mental burden. However, due to the pilot nature of the study, the results should be interpreted cautiously. Based on the findings further studies are currently planned.

Background: Acute tonsillitis (including tonsillopharyngitis) in childhood is a common disease with a peak of illness in school-age. Most of these cases have a viral origin and antibiotic therapy is not indicated, therefore, effective symptomatic therapy is required. For this reason, complementary, alternative and integrative medicine therapies might be a solution. Objective: The aim of this review is to demonstrate study status of such therapies. Methods: The databases PubMed, Cochrane Library, OVID, CAMbase, CAM-QUEST® and Anthromedics were systematically screened for studies investigating complementary, alternative and integrative therapy approaches in paediatric cohorts. Studies were analyzed by therapy approach, study design, cohort and outcome, using the PRISMA 2020 checklist. Results: The systematic literature search resulted in 321 articles. Five publications corresponded to the search criteria and were assigned to the following specific therapeutic categories: herbal medicine (3), homeopathy (1) and ayurvedic medicine (1). Clinical trials were found for the herbal compounds BNO 1030 (Impupret®) and EPs® 7630 (Umckaloabo), the homeopathic complex Tonzolyt® and the ayurvedic medicine Kanchnara-Guggulu and Pratisarana of Tankana‑Madhu. Antimicrobial effects of essential oils and carvacrol as single agents as well as in combination with erythromycin were analysed in an in vitro study. Conclusion: Clinical studies indicate an improvement of symptoms and a good tolerability of all investigated remedies of complementary, alternative and integrative medicine in the treatment of tonsillitis in childhood. Nevertheless, quality and quantity of the studies were insufficient to make a reliable conclusion regarding effectiveness. Therefore, more clinical trials are urgently needed to achieve a meaningful result.

Abstract Introduction The identification of typologies of health care users and their specific characteristics can be performed using cluster analysis. This statistical approach aggregates similar users based on their common health-related behavior. This study aims to examine health care utilization patterns using cluster analysis; and the associations of health care user types with sociodemographic, health-related and health-system related factors. Methods Cross-sectional data from the 2012 National Health Interview Survey were used. Health care utilization was measured by consultations with a variety of medical, allied and complementary health practitioners or the use of several interventions (exercise, diet, supplementation etc.) within the past 12 months (used vs. not used). A model-based clustering approach based on finite normal mixture modelling, and several indices of cluster fit were determined. Health care utilization within the cluster was analyzed descriptively, and independent predictors of belonging to the respective clusters were analyzed using logistic regression models including sociodemographic, health- and health insurance-related factors. Results Nine distinct health care user types were identified, ranging from nearly non-use of health care modalities to over-utilization of medical, allied and complementary health care. Several sociodemographic and health-related characteristics were predictive of belonging to the respective health care user types, including age, gender, health status, education, income, ethnicity, and health care coverage. Conclusions Cluster analysis can be used to identify typical health care utilization patterns based on empirical data; and those typologies are related to a variety of sociodemographic and health-related characteristics. These findings on individual differences regarding health care access and utilization can inform future health care research and policy regarding how to improve accessibility of different medical approaches.

Abstract Purpose Antibiotics are one possible treatment for patients with recurrent acute throat infections (ATI), but effectiveness can be modest. In view of worries over antibiotic resistance, treatment pathways that reduce recurrence of ATI are essential from a public health perspective. Integrative treatment strategies can be an option but there is still a high demand to provide evidence of their cost effectiveness. Methods We constructed a 4-state Markov model to compare the cost-effectiveness of SilAtro-5-90 as adjuvant homeopathic therapy to care as usual with care as usual alone in reducing the recurrence of ATI for children and adults with suspected moderate recurrent tonsillitis. The analysis was performed from a societal perspective in Germany over a 2-year period. Results are reported separately for children < 12 and for individuals aged 12 and over. The model draws on evidence from a multi-centre randomised clinical trial that found this strategy effective in reducing recurrence of ATI. Costs in 2019 € and outcomes after 1 year are discounted at a rate of 3% per annum. Results For adults and adolescents aged 12 years and over, incremental cost per ATI averted in the adjuvant therapy group was €156.64. If individuals enter the model on average with a history of 3.33 previous ATIs, adjuvant therapy has both lower costs and better outcomes than care as usual. For children (< 12 years) adjuvant therapy had both lower costs and ATI than care as usual. The economic case is stronger if adjuvant treatment reduces surgical referral. At a hypothetical cost per ATI averted threshold of €1000 probabilistic sensitivity analysis suggests Silatro-5-90 has a 65% (adults) and 71% (children) chance of being cost-effective. Conclusion Our results indicate the importance of considering homeopathy as adjuvant therapy in the treatment of ATIs in individuals with recurrent tonsillitis from a socio-economic perspective. Further evaluation should assess how differences in uptake and sustained use of homeopathic adjuvant therapy, as well as changing patterns of antibiotic prescribing, impact on cost effectiveness.

Abstract Background Cancer registries usually assess data of conventional treatments and/or patient survival. Beyond that, little is known about the influence of other predictors of treatment response related to the use of complementary therapies (CM) and lifestyle factors affecting patients’ quality and quantity of life. Methods INTREST is a prospective cohort study collecting register data at multiple German certified cancer centers, which provide individualized, integrative, in- and outpatient breast cancer care. Patient-reported outcomes and clinical cancer data of anticipated N = 715 women with pTNM stage I-III breast cancer are collected using standardized case report forms at the time of diagnosis, after completing neo−/adjuvant chemotherapy, after completing adjuvant therapy (with the exception of endocrine therapy) as well as 1, 2, 5, and 10 years after baseline. Endpoints for multivariable prediction models are quality of life, fatigue, treatment adherence, and progression-based outcomes/survival. Predictors include the study center, sociodemographic characteristics, histologic cancer and comorbidity data, performance status, stress perception, depression, anxiety, sleep quality, spirituality, social support, physical activity, diet behavior, type of conventional treatments, use of and belief in CM treatments, and participation in a clinical trial. Safety is recorded following the Common Terminology Criteria for Adverse Events. Discussion This trial is currently recruiting participants. Future analyses will allow to identify predictors of short- and long-term response to integrative breast cancer treatment in women, which, in turn, may improve cancer care as well as quality and quantity of life with cancer. Trial registration German Clinical Trial Register DRKS00014852 . Retrospectively registered at July 4th, 2018.

Objective: Mindfulness-based interventions are increasingly used in health, economic and educational systems. There are numerous studies demonstrating the effectiveness of mindfulness-based interventions in the educational sectors (primary, secondary, and tertiary). This systematic review and meta-analysis assessed the current state of research on the effectiveness of mindfulness-based interventions on the academic performance of students as measured by their grade point average (GPA).Methods: Literature search was conducted in Psychology and Behavioral Sciences Collection, PsycARTICLES, PubMed, and Google Scholar through March 2022. The inclusion criteria were: (1) the use of GPA as a measure of students’ academic performance, (2) a sample that was subjected to a mindfulness-based intervention without medical indication, (3) the student status of the subjects. Meta-analysis was conducted using a random effects model with the generic inverse variance method.Results: The search included a total of 759 studies, of which six randomized controlled trials met the inclusion criteria. In these trials, significant group differences for GPA were found with effect sizes ranging from d = 0.16–1.62 yielding a significant overall effect of d = 0.42 (95% CI: 0.15–0.69) and a low magnitude of heterogeneity of I2 = 37%.Discussion: In conclusion, the first results of this emerging research field seem promising. However, the exact mechanisms of action are still unclear.

Abstract Background Integrative Medicine (IM) combines conventional and complementary therapies. It aims to address biological, psychological, social, spiritual and environmental aspects of patients’ health. During the past 20 years, the use and request of IM in children and adults has grown. Anthroposophic Medicine (AM) is an IM approach frequently used in children in Germany. From both public health and health economic perspectives, it is relevant to investigate whether there are differences in the resource utilization between integrative pediatric departments (IPD) and the entirety of all pediatric departments. Methods Standard ward documentation data from all German integrative anthroposophic pediatric departments (2005–2016; N = 29,956) is investigated and systematically compared to data of the entirety of all pediatric departments in Germany derived from the Institute for the Hospital Reimbursement System (2005–2016, N = 8,645,173). The analyses focus on: length of stay, Diagnosis Related Groups (DRG), Major Diagnosis Categories (MDC), and effective Case Mix Index (CMI). Results The length of stay in the IPD (M = 5.38 ± 7.31) was significantly shorter than the DRG defined length of stay (M = 5.8 ± 4.71; p

Non-dispersive infrared (NDIR) absorption spectroscopy is a widespread approach to gas sensing due to its selectivity and conceptual simplicity. One of the main challenges towards the development of fully integrated NDIR sensors is the design and fabrication of microstructures, typically waveguides, that can combine high sensitivity with the ease of integrability of other sensor elements (sources, filters, detectors). Here, we investigate theoretically and experimentally a class of coupled strip-array (CSA) waveguides realized on a SiO2/Si3N4 platform with mass semiconductor fabrication processes. We demonstrate that this class of waveguides shows comparable sensitivity for a wide range of presented geometries, making it a very promising platform for satisfying multiple sensor and fabrication requirements without loss of performance.

In drug studies, patients are often included when the disease activity is high. This will make any treatment appear to lessen disease activity, although the improvement is biased by selection. This effect is known as regression towards the mean (RTM). We aimed at investigating drug trials in Pulmonary Arterial Hypertension (PAH) using the 6-minute walking distance test (6MWD) as a primary outcome for the phenomenon of RTM. An existing registry of 43 open label studies and 23 randomized controlled trials conducted between 1990 and 2009 was used as the data source. Data analysis was carried out for 18 randomized controlled trials (RCTs) and 24 open label studies out of this registry. Data were analyzed for verum and placebo arms of the RCTs separately, as well as for the open label arms. In the verum arms, the overall effect given as 33.2 m (95% CI: 25.7; 40.6]); 6MWD was slightly lower than the effect in the observational studies, with 44.6 m (95% CI: [25.4; 63.8]). After studying and interpreting the data, we found that regression towards the mean plays only a minor role in PAH studies. In particular, placebo effects in the RCTs were negligibly small, with a mean 6MWD of −2.5 m (95% CI: [−9.8; 4.7]) in the placebo arm. Therefore, our analysis indicates that results of non-randomized observational studies can be regarded as valid tools for gaining valid clinical effects in patients with PAH.

Abstract Background Integrative medicine (IM) is a patient-centered, evidence-based, therapeutic paradigm which combines conventional and complementary approaches. The use of IM in pediatrics has increased in the past two decades and parents’ demand for it is growing. An IM whole systems approach is anthroposophic medicine. Considering the growing demand for integrative approaches in children, it is relevant from a public health perspective to find out which kind of children use IM in Germany and whether they differ from the entirety of pediatric inpatients in Germany. Moreover, it would be interesting to known, whether these patients are willing to travel a longer distance to gain integrative treatment. Methods The present study investigates the standard ward documentation datasets of 29,956 patients of all German integrative anthroposophic pediatric inpatient wards from 2005 to 2016 and compares them systematically to collect data of the entirety of all pediatric inpatient wards in Germany. Apart from patients’ age and gender, and the ICD-10 admission diagnoses, the geographical catchment area of the hospitals were analyzed. Results Sociodemographic characteristics of pediatric inpatients in the integrative anthroposophic departments (IAH) did not differ from the entirety of all pediatric inpatients. Regarding clinical characteristics, higher frequencies were found for endocrine, nutritional and metabolic diseases (IAH: 7.24% vs. 2.98%); mental, behavioral, and neurodevelopmental disorders (IAH: 9.83% vs. 3.78%) and nervous diseases (IAH: 8.82% vs. 5.16%) and lower frequencies for general pediatric diseases such as respiratory diseases (IAH: 17.06% vs. 19.83%), digestive diseases (IAH: 3.90% vs. 6.25%), and infectious and parasitic diseases (IAH: 12.88% vs. 14.82%) in comparison to the entirety of all pediatric inpatients in Germany. The IAH showed a broad catchment area, with most patients being from former, Western federal republic of Germany. Large catchment areas (> 100 km) for the IAH are merely covered by severe and chronic diseases. Conclusion Pediatric inpatients of IAH do not differ from the entirety of pediatric inpatients in Germany regarding sociodemographic characteristics but show differences regarding clinical characteristics. Parents are willing to travel further distance to get specialized integrative anthroposophic medical care for children with severe and chronic diseases.

The aim of this study was to investigate the impact of cross-linked hyaluronic acid on osteoblast-like cells seeded on top of two collagen substrates, native porcine pericardium membrane (substrate A) and ribose cross-linked collagen membranes (substrate B), in an air-lift model. Substrates A or B, saturated with three hyaluronic acid concentrations, served as membranes for SAOS-2 cells seeded on top. Cultivation followed for 7 and 14 days in the air-lift model. Controls used the same substrates without hyaluronic pre-treatment. Cells were harvested, and four (Runx2, BGLAP, IBSP, Cx43) different osteogenic differentiation markers were assessed by qPCR. Triplicated experiment outcomes were statistically analyzed (ANOVA, t-test; SPSS). Supplementary histologic analysis confirmed the cells’ vitality. After seven days, only few markers were overexpressed on both substrates. After 14 days, targeted genes were highly expressed on substrate A. The same substrate treated with 1:100 diluted xHyA disclosed statistically significant different expression level vs. substrate B (p = 0.032). Time (p = 0.0001), experimental condition as a function of time (p = 0.022), and substrate (p = 0.028) were statistically significant factors. Histological imaging demonstrated vitality and visualized nuclei. We conclude that the impact of hyaluronic acid resulted in a higher expression profile of SAOS-2 cells on substrate A compared to substrate B in an air-lift culture after two weeks.

Background: Acute bronchitis is one of the most common pediatric diseases. In addition to conventional therapies, a frequent use of complementary and alternative medicine (CAM) has been stated. Anthroposophic medicine (AM) is one of the most practiced complementary and integrative medicine (CIM) approaches in Central Europe but hitherto no consensus-based clinical recommendations or guidelines are available.Therefore, a consensus-based recommendation leading to an informed and reasonable use of AM in the treatment of acute bronchitis in pediatrics was developed. Methods: A total of 61 physicians in Germany with expertise in the field of anthroposophic pediatrics was invited to complete an online multistep Delphi process. Two independent reviewers quantitatively and qualitatively evaluated the results. The survey was completed when >75 % consensus was achieved. Results: The clinical recommendation comprises 15 subitems related to treatment as well as clinical and psychosocial aspects. All items reached strong consensus (>90 %; N = 9) or consensus (75–90 %; N = 6). Conclusion: The comprehensive clinical recommendation creates a scientific base for the anthroposophic integrative treatment of acute bronchitis in children in Germany. It will make the anthroposophic approach more applicable, understandable and comparable to a wider public of physicians and other health professionals in Germany.

Lifestyle interventions can have a positive impact on quality of life and psychological parameters in patients with metabolic syndrome (MetS). In this randomized controlled trial, 145 participants with MetS (62.8% women; 59.7 ± 9.3 years) were randomized to (1) 5-day fasting followed by 10 weeks of lifestyle modification (F + LM; modified DASH diet, exercise, mindfulness; n = 73) or (2) 10 weeks of lifestyle modification only (LM; n = 72). Outcomes were assessed at weeks 0, 1, 12, and 24, and included quality of life (Short-Form 36 Health Survey Questionnaire, SF-36), anxiety/depression (Hospital Anxiety and Depression Scale, HADS), stress (Cohen Perceived Stress Scale, CPSS), mood (Profile of Mood States, POMS), self-efficacy (General Self-Efficacy Scale, GSE), mindfulness (Mindfulness Attention Awareness Scale, MAAS), and self-compassion (Self-Compassion Scale, SCS). At week 1, POMS depression and fatigue scores were significantly lower in F + LM compared to LM. At week 12, most self-report outcomes improved in both groups—only POMS vigor was significantly higher in F + LM than in LM. Most of the beneficial effects within the groups persisted at week 24. Fasting can induce mood-modulating effects in the short term. LM induced several positive effects on quality of life and psychological parameters in patients with MetS.

Abstract Throughout the history of medicine, many functions have been attributed to the spleen and numerous researchers have focused on a postulated digestive function. Beginning in 1825, systematic animal studies showed evidence for a postprandial increase in splenic volume (SV) with a peak 30 min to five hours after food intake. Since the introduction of imaging techniques, two studies have been conducted on humans, revealing a decrease in SV 30 to 45 min postprandially. The aim of this study was to examine possible postprandial changes in SV over a period of seven hours. The ethics‐approved, randomized crossover study included 10 healthy volunteers, who received a standardized meal (3,600 kJ) on one study day and fasted on the other. Sonographic measurements were obtained at six measurement points on each day. Thirty minutes after the meal, SV increased significantly by 38.2 ± 51.2 cm3 (17.3%; p = .04) compared to the baseline measurement and decreased gradually afterward. In males, SV 30 min after the meal was 70.2 ± 21.6 cm3 higher (p = .002) compared to the fasting condition and 60 min later it was still significantly increased. The apparent SV increase after food intake is discussed in relation to hemodynamic changes in the splanchnic region. It seems plausible that the spleen has a rhythmic and regulative function within the portal system, something which warrants further research and should be taken more into account in nutritional physiology.

Abstract Background The implementation of standardised, valid and reliable measurements in palliative care is subject to practical and methodological challenges. One aspect of ongoing discussion is the value of systematic proxy-based assessment of symptom burden in palliative care. In 2011, an expert-developed proxy-based instrument for the assessment of symptom burden in palliative patients, the Palliative Symptom Burden Score (PSBS), was implemented at the Specialised Palliative Care Unit of the University Medical Centre in Dusseldorf, Germany. The present study investigated its feasibility, acceptance and psychometric properties. Methods The PSBS was rated by nursing staff three times a day over 5 years (N = 820 patients). Feasibility and nurses’ acceptance of PSBS were analysed. Structural validity was investigated by principal component analysis. Construct validity was examined via cross-validation with the Hospice and Palliative Care Evaluation checklist. Discriminative validity of the PSBS was analysed by means of Kruskal-Wallis test of patients’ performance score. Reliability of the PSBS was evaluated by internal consistency analysis, test-retest and split-half-reliability. Inter-rater reliability was investigated by observer agreement of nurses’ ratings of symptom burden within a day. Sensitivity to change was analysed by Wilcoxon test with repeated measures of the PSBS before and after palliative complex treatment. Results A high degree of acceptance and the feasibility of a high-frequency proxy-based symptom burden assessment approach were demonstrated. There were low rates of missing values and no indications of the adoption of prior ratings. PSBS in its present form demonstrates good structural and construct validity (r s = .27–.79, p’s

Abstract Stress is an important co-factor for the genesis and maintenance of many diseases and is known to have an effect on gene expression via epigenetic regulation. MicroRNAs (miRNAs) appear to function as one of the key factors of this regulation. This is the first study to investigate the response of 11 stress-associated miRNAs in human saliva - as a non-invasive source - in an experimental condition of acute psychological stress, and also their correlation with established psychological (subjective stress perception), physiological (heart rate and heart rate variability) and biochemical stress parameters (salivary cortisol and alpha-amylase). 24 healthy participants between 20 and 35 years of age were investigated, using the Trier Social Stress Test (TSST) to induce acute psychological stress. Stress-associated changes were significant for miR-20b, -21 and 26b, and changes in miR-16 and -134 were close to significance, recommending further research on these miRNAs in the context of stress reactions. Significant correlations with alpha-amylase suggest their integration in sympathetic stress regulation processes. Additionally, our results demonstrate the TSST as a reliable tool for studying salivary miRNAs as non-invasive indicators of epigenetic processes in acute psychological stress reactions.

Abstract Background Spinal disc herniation is a frequently occurring degenerative disease of the spine. Many patients undergoing surgery suffer from radicular pain, known as memory pain, beginning from the third post-operative day. This results in the prescription of high-dose opioid medications. In homeopathy, Hypericum perforatum is known as a remedy for unbearable, shooting or jabbing pain especially when neural damage is involved. Reduction of pain after application of H. perforatum has been observed in previous studies. This study is aimed to investigate whether homeopathic H. perforatum in a potentisation of C200 leads to the reduction of post-operative pain and a decrease of pain medication compared to placebo. Methods/design This is a monocentric, double-blind, randomised placebo-controlled trial conducted at the Department of Neurosurgery at the Community Hospital Herdecke, Germany. One hundred study participants are being recruited from inpatients undergoing elective, monosegmental, lumbar microdiscectomy surgery. Patients are randomly allocated to receive homeopathic treatment or placebo in addition to usual pain management after surgery. The primary clinical outcome is pain reduction after 3 days of inpatient care as measured by pain reduction of subjective pain on a 100-mm Visual Analogue Scale (VAS) at the third post-operative day. Statistical analysis will be carried out by means of a covariance model with adjustment for baseline values and patient expectation for all randomised patients. Discussion This study is the first trial of classical homeopathy that will evaluate the efficacy of homeopathic H. perforatum after monosegmental spinal microdiscectomy. We intend to clarify the potential of homoeopathic H. perforatum to reduce surgery-associated pain. Trial registration German Clinical Trials Register, ID: DRKS00007913. Registered on 17 October 2014. EudraCT – Nr: 2013–001383-31. Data sets from the German Clinical Trials Register (DRKS, Deutsches Register Klinischer Studien) are updated every 4 weeks automatically to the International Clinical Trials Registry Platform of World Health Organisation: http://apps.who.int/trialsearch/. Responsibilities Sponsor: Witten/Herdecke University Alfred-Herrhausen-Straße 50 58,448 Witten Deputy of the sponsor: Dr. Wolfgang Eglmeier (Head of Centre for Clinical Trials Witten/Herdecke) Alfred-Herrhausen-Straße 50 58,448 Witten E-mail: wolfgang.eglmeier@uni-wh.de Principal investigator: Prof. Dr. med. Wolfram Scharbrodt Community Hospital Herdecke Department for Neurosurgery Gerhard-Kienle-Weg 4 58,313 Herdecke w.scharbrodt@gemeinschaftskrankenhaus.de Project coordination: Christa Raak Faculty for Health (Department for Integrative and Anthroposophic Medicine) University Witten/Herdecke gGmbh Gerhard-Kienle-Weg 4 58,313 Herdecke christa.raak@uni-wh.de Project manager/data analysis/biometry: Prof. Dr. Thomas Ostermann Faculty for Health (Department for Psychology and Psychotherapy) University Witten/Herdecke gGmbh Alfred-Herrhausen-Straße 50 58,448 Witten thomas.ostermann@uni-wh.de

This study aims to contribute to the knowledge about lacking or contradictory effects of benzodiazepine on hyperaroused or aggressive behaviour in persons with intellectual disability (ID). We conducted a retrospective and natural case study in a person with mild ID and multiple adverse childhood experiences (ACE), using routine diary data consisting of 275 days including 113 consecutive days under benzodiazepine medication. The medication effects were documented as "calm/relaxed", "fretful/distressed" and "sleep/doze". Transitions between these were modelled using Markov chains. Differences in transitions were analysed using Chi-Square test for homogeneity. The results show a significantly reduced stability of mood and increased distressed behaviour under benzodiazepine. This is in line with reports about the effects of psychotropic medication in patients with ID and challenging behaviour. Besides other influences on unexpected medication effects, a possible dissociative identity disorder is discussed as an additional explanation.

The use of molecular biology tools in the field of bioadhesion is still in its infancy. For new research groups who are considering taking a molecular approach, the techniques presented here are essential to unravelling the sequence of a gene, its expression and its biological function. Here we provide an outline for addressing adhesion-related genes in diverse organisms. We show how to gradually narrow down the number of candidate transcripts that are involved in adhesion by (1) generating a transcriptome and a differentially expressed cDNA list enriched for adhesion-related transcripts, (2) setting up a BLAST search facility, (3) perform an in situ hybridization screen, and (4) functional analyses of selected genes by using RNA interference knock-down. Furthermore, latest developments in genome-editing are presented as new tools to study gene function. By using this iterative multi-technologies approach, the identification, isolation, expression and function of adhesion-related genes can be studied in most organisms. These tools will improve our understanding of the diversity of molecules used for adhesion in different organisms and these findings will help to develop innovative bio-inspired adhesives.

Aim. Testing the effectiveness of peer support additionally to a disease management programme (DMP) for type 2 diabetes patients. Methods. Unblinded cluster-randomised controlled trial (RCT) involving 49 general practices, province of Salzburg, Austria. All patients enrolled in the DMP were eligible, n=337 participated (intervention: 148 in 19 clusters; control: 189 in 20 clusters). The peer support intervention ran over 24 months and consisted of peer supporter recruitment and training, and group meetings weekly for physical exercise and monthly for discussion of diabetes related topics. Results. At two-year follow-up, adjusted analysis revealed a nonsignificant difference in HbA1c change of 0.14% (21.97 mmol/mol) in favour of the intervention (95% CI −0.08 to 0.36%, p=0.22). Baseline values were 7.02 ± 1.25% in the intervention and 7.08 ± 1.25 in the control group. None of the secondary outcome measures showed significant differences except for improved quality of life (EQ-5D-VAS) in controls (4.3 points on a scale of 100; 95% CI 0.08 to 8.53, p=0.046) compared to the intervention group. Conclusion. Our peer support intervention as an additional DMP component showed no significant effect on HbA1c and secondary outcome measures. Further RTCs with a longer follow-up are needed to reveal whether peer support will have clinically relevant effects. Trial Registration. This trial has been registered with Current Controlled Trials Ltd. (ISRCTN10291077).

Complementary and alternative therapies and medicines (CAM) such as acupuncture or mistletoe treatment are much asked for by cancer patients. With a growing interest in such therapies, physicians need a simple tool with which to get an overview of the scientific publications on CAM, particularly those that are not listed in common bibliographic databases like MEDLINE. CAMbase is an XML-based bibliographical database on CAM which serves to address this need. A custom front end search engine performs semantic analysis of textual input enabling users to quickly find information relevant to the search queries. This article describes the technical background and the architecture behind CAMbase, a free online database on CAM (www.cambase.de). We give examples on its use, describe the underlying algorithms and present recent statistics for search terms related to complementary therapies in oncology.