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CA extern 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.

Periods of fasting and refeeding may reduce cardiometabolic risk elevated by Western diet. Here we show in the substudy of NCT02099968, investigating the clinical parameters, the immunome and gut microbiome exploratory endpoints, that in hypertensive metabolic syndrome patients, a 5-day fast followed by a modified Dietary Approach to Stop Hypertension diet reduces systolic blood pressure, need for antihypertensive medications, body-mass index at three months post intervention compared to a modified Dietary Approach to Stop Hypertension diet alone. Fasting alters the gut microbiome, impacting bacterial taxa and gene modules associated with short-chain fatty acid production. Cross-system analyses reveal a positive correlation of circulating mucosa-associated invariant T cells, non-classical monocytes and CD4+ effector T cells with systolic blood pressure. Furthermore, regulatory T cells positively correlate with body-mass index and weight. Machine learning analysis of baseline immunome or microbiome data predicts sustained systolic blood pressure response within the fasting group, identifying CD8+ effector T cells, Th17 cells and regulatory T cells or Desulfovibrionaceae, Hydrogenoanaerobacterium, Akkermansia, and Ruminococcaceae as important contributors to the model. Here we report that the high-resolution multi-omics data highlight fasting as a promising non-pharmacological intervention for the treatment of high blood pressure in metabolic syndrome patients., Nutritional modification including fasting has been shown to reduce cardiometabolic risk linked to western diet. Here the authors show implementation of fasting resulted in alterations to the intestinal microbiota, and circulating immune cells, improving blood pressure and body weight in patients with metabolic syndrome.

There is a lack of data on associations between modern vegetarian and vegan diets and health among children and adolescents. The aim of the Vechi Youth Study was to cross-sectionally examine anthropometry, dietary intakes and nutritional status in a sample of 149 vegetarian, 115 vegan and 137 omnivore children and adolescents (6–18 years old, mean age: 12.7 ± 3.9 years). Group differences of dietary intake (calculated from three-day dietary records), nutrient biomarker and blood lipid concentrations were assessed using an analysis of covariance, adjusted for sex, age and other covariates. The total energy intake did not differ significantly between groups, but intake of carbohydrates was higher among vegetarians and vegans than among omnivores (p = 0.0002, respectively). The median protein intake exceeded 0.9 g/kg body weight/day in all diet groups and was lowest among vegetarians (p &lt, 0.02). There was no significant difference of haemoglobin, vitamin B2, 25-OH vitamin D3, HDL-C and triglycerides blood concentrations between diet groups. Vegan participants had higher folate concentrations than vegetarian participants (p = 0.0053). Ferritin concentration was significantly higher in omnivores than in vegetarians (p = 0.0134) and vegans (p = 0.0404). Vegetarians had lower concentrations of holotranscobalamin (p = 0.0042) and higher concentrations of methylmalonic acid (p = 0.0253) than omnivores. Vegans had the lowest non-HDL-C and LDL-C concentrations in comparison to vegetarians (p = 0.0053 and p = 0.0041) and omnivores (p = 0.0010 and p = 0.0010). A high prevalence (&gt, 30%) of 25-OH vitamin D3 and vitamin B2 concentrations below reference values were found irrespective of the diet group. In conclusion, the Vechi Youth Study did not indicate specific nutritional risks among vegetarian and vegan children and adolescents compared to omnivores.

AIM To determine the potential anti-inflammatory effect of a multimodal periodic fasting programme on surrogate parameters of periodontal inflammation in hospitalized patients diagnosed for metabolic syndrome (MetS). MATERIAL AND METHODS A total of 47 patients were recruited and hospitalized in an integrative ward for an intensified two-week multimodal fasting, diet and lifestyle programme. Patients were periodontally examined at baseline (t1), after the 2-week fasting protocol (t2) and, subsequently, 4 months after fasting (t3). The following parameters were determined: periodontal screening index (PSI), bleeding on probing (BOP), gingival crevicular fluid volume (GCF), plaque index (PI), C-reactive protein (CRP), blood pressure (BP), waist circumference (WC), fasting glucose (FGLU), triglycerides (TRG), high-density lipoprotein (HDL) and HbA1c. RESULTS A total of 28 female and 8 male patients fulfilled the defined criteria for MetS and were analysed separately by gender. At t2, BOP and GCF were reduced when compared to t1 (median: t2 = 39; t1 = 33.1%; p

Objectives: The present study examined the effects of a yoga and mindfulness-based programme on the autonomic nervous system of primary school children by using heart rate variability parameters. Design: A two-arm non-randomised controlled trial compared an integrated yoga and mindfulness-based programme (16 weeks) to conventional primary school lessons. Setting: Primary school classrooms and conference rooms. Interventions: Participants were allocated to a 16-week integrated yoga-based programme or conventional school lessons. A subgroup was randomised to receive 24h electrocardiogram-recordings. Main outcome measures: Heart rate variability indices were measured, both linear (time and frequency domain) and non-linear (symbolic dynamics, compression entropy), calculated from 30-minute extracts of Holter-electrocardiogram-recordings. Assessments were conducted at baseline and at the end of intervention. Results: 40 participants (42.5% female) were included into the analysis of HRV. No significant changes in heart rate variability parameters were observed between the groups after 16 weeks. In the intervention group, a trend towards increased parasympathetic activity could be seen over time, although not significantly enhanced compared to the control group. Conclusion: Results obtained here do not clearly show that children in German primary school settings benefit from an integrated yoga-based intervention. However, exploratory post-hoc analyses point interestingly to an increased nocturnal parasympathetic activity in the intervention group. Further studies are required with high-quality study designs, larger sample sizes and longer-term follow-ups.

Background The mortality of metabolic-obesity phenotypes has been thoroughly studied, but it is not known if or how the association between mortality and body mass index (BMI), waist circumference or a body shape index (ABSI) differ in strata of cardiometabolic health status. Methods We linked data on 12,815 men and women aged 36–79 years from the SAMINOR 1 Survey with mortality data from the Norwegian Cause of Death Registry. We defined metabolically healthy and unhealthy as having zero and ≥ 1, respectively, of the following: MetS, pre-existing diabetes or cardiovascular disease (CVD), or prescribed drugs for high blood pressure, hyperglycaemia or dyslipidaemia. We defined general and abdominal obesity as BMI ≥ 30 kg/m2 and waist circumference ≥ 88 cm (women) or 102 cm (men), respectively, and cross-classified these categories with metabolic status to create metabolically healthy non-obese and obese (MHNO and MHO) and metabolically unhealthy non-obese and obese (MUNO and MUO) phenotypes. We used Cox regression to estimate the hazard ratio (HR) for all-cause and CVD mortality for 1) the four phenotypes and 2) BMI, waist circumference and ABSI fitted with restricted cubic splines. We adjusted for age and lifestyle, and tested for interactions with sex and metabolic status (only continuous measures). Results The MHO phenotype was present in 7.8% of women and 5.8% of men. During a median follow-up of 15.3/15.2 years, 596/938 women/men had died, respectively. The MUNO and MUO groups had higher mortality than the MHNO group. Sex and phenotypes interacted with respect to CVD mortality: relative to the MHNO group, the MHO group had an adjusted HR (95% confidence interval) for CVD mortality of 1.05 (0.38–2.88) in women and 2.92 (1.71–5.01) in men. We found curvilinear associations between BMI/waist circumference and all-cause mortality irrespective of metabolic status. Corresponding relationships with CVD mortality were linear and the slope differed by sex and metabolic status. ABSI was linearly and positively associated with all-cause and CVD mortality in men. Conclusion The relationships between BMI, waist circumference or ABSI and mortality differed by sex, metabolic status and cause of death. Poor metabolic health substantially increases mortality regardless of obesity status.

Background We investigated daily blood pressure (BP) changes during fasting periods ranging from 4 to 41 (10.0±3.8) days in a cohort of 1610 subjects, including 920 normotensive, 313 hypertensive nonmedicated, and 377 hypertensive medicated individuals. Methods and Results Subjects underwent a multidisciplinary fasting program with a daily intake of ≈250 kcal. Weight and stress scores decreased during fasting, and the well‐being index increased, documenting a good tolerability. BP mean values decreased from 126.2±18.6/81.4±11.0 to 119.7±15.9/77.6±9.8 mm Hg (mean change, −6.5/3.8 mm Hg). BP changes were larger for hypertensive nonmedicated subjects (>140/90 mm Hg) and reduced by 16.7/8.8 mm Hg. This reduction reached 24.7/13.1 mm Hg for hypertensive nonmedicated subjects (n=76) with the highest BP (>160/100 mm Hg). In the normotensive group, BP decreased moderately by 3.0/1.9 mm Hg. Interestingly, we documented an increase of 6.3/2.2 mm Hg in a subgroup of 69 female subjects with BP Conclusions Long‐term fasting tends to decrease BP in subjects with elevated BP values. This effect persisted during the 4 days of stepwise food reintroduction, even when subjects stopped their antihypertensive medication. Registration URL: https://www.drks.de/drks_web/ ; Unique identifier: DRKS00010111.

Background/objectives A few preliminary studies have documented the safety and feasibility of repeated short-term fasting in patients undergoing chemotherapy. However, there is a lack of data from larger randomized trials on the effects of short-term fasting on quality of life, reduction of side effects during chemotherapy, and a possible reduction of tumor progression. Moreover, no data is available on the effectiveness of fasting approaches compared to so-called healthy diets. We aim to investigate whether the potentially beneficial effects of short-term fasting can be confirmed in a larger randomized trial and can compare favorably to a plant-based wholefood diet. Methods This is a multicenter, randomized, controlled, two-armed interventional study with a parallel group assignment. One hundred fifty patients, including 120 breast cancer patients and 30 patients with ovarian cancer, are to be randomized to one of two nutritional interventions accompanying chemotherapy: (1) repeated short-term fasting with a maximum energy supply of 350–400 kcal on fasting days or (2) repeated short-term normocaloric plant-based diet with restriction of refined carbohydrates. The primary outcome is disease-related quality of life, as assessed by the functional assessment of the chronic illness therapy measurement system. Secondary outcomes include changes in the Hospital Anxiety and Depression Score and as well as frequency and severity of chemotherapy-induced side effects based on the Common Terminology Criteria of Adverse Events. Explorative analysis in a subpopulation will compare histological complete remissions in patients with neoadjuvant treatments. Discussion/planned outcomes Preclinical data and a small number of clinical studies suggest that repeated short-term fasting may reduce the side effects of chemotherapy, enhance quality of life, and eventually slow down tumor progression. Experimental research suggests that the effects of fasting may partly be caused by the restriction of animal protein and refined carbohydrates. This study is the first confirmatory, randomized controlled, clinical study, comparing the effects of short-term fasting to a short-term, plant-based, low-sugar diet during chemotherapy on quality of life and histological tumor remission. Trial registration ClinicalTrials.gov NCT03162289 . Registered on 22 May 2017

The obesity epidemic is dynamic with varying secular trends and differences between countries and ethnic groups. The objective of this study was to describe the age- and sex-specific longitudinal changes in weight and waist circumference in a rural Norwegian population with a high proportion of the indigenous Sami population. Based on two population-based surveys, SAMINOR 1 (2003–2004) and SAMINOR 2 (2012–2014), we present longitudinal changes in weight and waist circumference according to age at baseline in the SAMINOR 1 Survey and sex during the 10-year period. The analyses included 1538 men and 1958 women aged 36 to 69 at baseline (birth year 1934 to 1967). Forty-one percent of the population were Sami. Both weight and waist circumference were measured. The mean weight increased 0.8 kg (95% confidence interval: 0.5, 1.1) in men and 0.3 kg (95% confidence interval: 0, 0.5) in women. In both men and women, younger individuals gained significantly more weight during the 10-year follow-up than older participants (p < 0.001). The mean weight showed a statistically significant increase in men aged 36–54 and women aged 36–49 at baseline and was statistically significantly reduced in men and women aged 60–69. The mean waist circumference increased by 6.3 cm (95% confidence interval: 6.0, 6.6) in men and 8.4 cm (95% confidence interval 8.1, 8.8) in women. The mean waist circumference increased statistically significantly from SAMINOR 1 to SAMINOR 2 in all age groups, and there was an inverse relationship between age at baseline and change in waist circumference (p < 0.001). Waist circumference increased more than can be explained by changes in weight and age during the 10-year period. The inverse relationships between age at baseline in SAMINOR 1 and the 10-year change in weight and waist circumference were found in both Sami and non-Sami participants. The findings underline the need for prevention of obesity, particularly in younger people, as it is difficult to achieve permanent weight loss. Copyright: © 2020 Jacobsen et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

BackgroundPrevious studies have suggested that Sami have a similar risk of myocardial infarction and a higher risk of stroke compared with non-Sami living in the same geographical area.DesignParticipants in the SAMINOR 1 Survey (2003–2004) aged 30 and 36–79 years were followed to the 31 December 2016 for observation of fatal or non-fatal events of acute myocardial infarction (AMI), coronary heart disease (CHD), ischaemic stroke (IS), stroke and a composite endpoint (fatal or non-fatal AMI or stroke).AimCompare the risk of AMI, CHD, IS, stroke and the composite endpoint in Sami and non-Sami populations, and identify intermediate factors if ethnic differences in risks are observed.MethodsCox regression models.ResultsThe sex-adjusted and age-adjusted risks of AMI (HR for Sami versus non-Sami 0.99, 95% CI: 0.83 to 1.17), CHD (HR 1.03, 95% CI: 0.93 to 1.15) and of the composite endpoint (HR 1.09, 95% CI: 0.95 to 1.24) were similar in Sami and non-Sami populations. Sami ethnicity was, however, associated with increased risk of IS (HR 1.36, 95% CI: 1.10 to 1.68) and stroke (HR 1.31, 95% CI: 1.08 to 1.58). Height explained more of the excess risk observed in Sami than conventional risk factors.ConclusionsThe risk of IS and stroke were higher in Sami and height was identified as an important intermediate factor as it explained a considerable proportion of the ethnic differences in IS and stroke. The risk of AMI, CHD and the composite endpoint was similar in Sami and non-Sami populations.

Background People with intellectual disabilities (ID) have lower levels of physical activity than the general population. The aim of this study was to understand the motivational factors of participation in physical activity for people with ID from the perspectives of the family members and staff. Method An abductive qualitative design was used. Social Cognitive Theory constituted the theoretical frame of reference of the study. Two focus group interviews with health care workers and family members and two individual interviews with health care workers were conducted at their workplace. A thematic analysis was performed. Results Three main themes were identified. According to support persons, motivation could be promoted at the individual level by fun, mastery, social setting, technology and knowledge about health behaviours. At a contextual level, physical activity was mediated by engagement with support individuals and available resources. At an interactional level, individuals were more motivated if the interaction was featured by joint activities, predictability and the use of rewards. Conclusions Motivation for participation in physical activity might be promoted at the individual, contextual and interactional levels. The interactions between individuals with ID and their support persons should work in a supportive way and strengthen mastery experiences. Support and engagement in the context could serve as a prerequisite for motivation and participation in physical activity and should be considered when developing interventions for physical activity for individuals with ID. © 2020 The Authors. Journal of Intellectual Disability Research published by MENCAP and International Association of the Scientific Study of Intellectual and Developmental Disibilities and John Wiley & Sons Ltd This is an open access article under the terms of the Creative Commons Attribution License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited.

Background: Multiple sclerosis (MS) is the most common inflammatory disease of the central nervous system in young adults that may lead to progressive disability. Since pharmacological treatments may have substantial side effects, there is a need for complementary treatment options such as specific dietary approaches. Ketone bodies that are produced during fasting (FD) and ketogenic diets (KD) are an alternative and presumably more efficient energy source for the brain. Studies on mice with experimental autoimmune encephalomyelitis showed beneficial effects of KD and FD on disease progression, disability, cognition and inflammatory markers. However, clinical evidence on these diets is scarce. In the clinical study protocol presented here, we investigate if a KD and a FD are superior to a standard diet (SD) in terms of therapeutic effects and disease progression. Methods: This study is a single-center, randomized, controlled, parallel-group study. One hundred and eleven patients with relapsing-remitting MS with current disease activity and stable immunomodulatory therapy or no disease-modifying therapy will be randomized to one of three 18-month dietary interventions. The dietary interventions are 1) a KD with a restricted carbohydrate intake of 20-40 g/day, 2) a FD with a 7 day fast every 6 months and 14 hours daily intermittent fasting in between, and 3) a fat-modified SD as recommended by the German Nutrition Society. The primary outcome measure is the number of new T2-weighted MRI lesions after 18 months. Secondary endpoints are safety, changes in relapse rate, disability progression, fatigue, depression, cognition, quality of life, changes of gut microbiome as well as markers of inflammation, oxidative stress and autophagy. Safety and feasibility will also be assessed. Discussion: Preclinical data suggest that KD and FD may modulate immunity, reduce disease severity and promote remyelination in the mouse model of MS. However, clinical evidence is lacking. This study is the first clinical study investigating the effects of a KD and FD on disease progression of MS. Trial Registration: ClinicalTrials.gov; NCT03508414; Registered 25 April 2018, retrospectively registered; https://clinicaltrials.gov/ct2/show/NCT03508414

Background Yoga in school is a beneficial tool to promote the good health and well-being of students by changing the way they react to stress. The positive effects of yoga—taught in schools—on children, youth and young adults have been demonstrated in former studies using mostly subjective psychometric data. Aim The present trial aims to evaluate the potential effects of yoga on autonomic regulation in young adults by analyzing heart rate variability (HRV). Methods This study is a non-randomized, explorative, two-arm-pilot study with an active control group. Fourteen healthy young adults took part in a 10-week yoga program (90 min once a week) in school and were compared to a control group of 11 students who participated in conventional school sports (90 min once a week over 10 weeks). 24-hour electrocardiograms (ECGs) were recorded at baseline and following the 10-week intervention. From 20-minute of nocturnal sleep phases, HRV parameters were calculated from linear (time and frequency domain) and nonlinear dynamics (such as symbolic dynamics and Poincaré plot analysis). Analyses of variance (ANOVA) followed by t-tests as post-hoc tests estimating both statistical significance and effect size were used to compare pre-post-intervention for the two groups. Results The statistical analysis of the interaction effects did not reveal a significant group and time interaction for the individual nocturnal HRV indices. Almost all indices revealed medium and large effects regarding the time main effects. The changes in the HRV indices following the intervention were more dramatic for the yoga group than for the control group which is reflected in predominantly higher significances and stronger effect sizes in the yoga group. Conclusion In this explorative pilot trial, an increase of HRV (more parasympathetic dominance and overall higher HRV) after ten weeks of yoga in school in comparison to regular school sports was demonstrated, showing an improved self-regulation of the autonomic nervous system.

Objective Ayurveda is commonly used in South Asia to treat knee osteoarthritis (OA). We aimed to evaluate the effectiveness of Ayurvedic treatment compared to conventional conservative care in patients with knee OA. Method According to American College of Rheumatology (ACR) criteria knee OA patients were included in a multicenter randomized, controlled, open-label trial and treated in 2 hospital clinics and 2 private outpatient clinics in Germany. Participants received either a multi-modal Ayurvedic treatment or multi-modal conventional care with 15 treatments over 12 weeks respectively. Primary outcome was the change on the Western Ontario and McMaster University Osteoarthritis (WOMAC) Index after 12 weeks. Secondary outcomes included WOMAC subscales; the pain disability index and a pain experience scale, numeric rating scales for pain and sleep quality, quality-of-life and mood, rescue medication use, and safety issues. Results One hundred fifty-one participants (Ayurveda n = 77, conventional care n = 74) were included. Changes of the WOMAC Index from baseline to 12 weeks were more pronounced in the Ayurveda group (mean difference 61.0 [95%CI: 52.4;69.6]) than in the conventional group (32.0 [95%CI: 21.4;42.6]) resulting in a significant between-group difference (p < 0.001) and a clinically relevant effect size (Cohen's d 0.68 [95% CI:0.35;1.01]). Similar trends were observed for all secondary outcomes at week 12. Effects were sustained at follow-ups after 6 and 12 months. Conclusion Results suggest that Ayurvedic treatment is beneficial in reducing knee OA symptoms. Further studies should be conducted to confirm the magnitude of the effect and to clarify the role of different treatment components and non-specific effects. Registration at clinicaltrials.gov (NCT01225133; initial release 10/06/2010).

Objectives Ayurveda claims to be effective in the treatment of psychosomatic disorders by means of lifestyle and nutritional counseling. Design In a randomized controlled study mothers with burnout were randomized into two groups: Ayurvedic nutritional counseling (according to tradition), and conventional nutritional counseling (following the recommendations of a family doctor). Patients received five counseling sessions over twelve weeks. Main outcome measures Outcomes included levels of burnout, quality of life, sleep, stress, depression/anxiety, and spirituality at three and six months. It also included a qualitative evaluation of the communication processes. Results We randomized thirty four patients; twenty three participants were included in the per protocol analysis. No significant differences were observed between the groups. However, significant and clinically relevant intra-group mean changes for the primary outcome burnout, and secondary outcomes sleep, stress, depression and mental health were only found in the Ayurveda group. The qualitative part of the study identified different conversational styles and counseling techniques between the two study groups. In conventional consultations questions tended to be category bound, while counseling-advice was predominantly admonitory. The Ayurvedic practitioner used open-ended interrogative forms, devices for displaying understanding, and positive re-evaluation more frequently, leading to an overall less asymmetrical interaction. Conclusions We found positive effects for both groups, which however were more pronounced in the Ayurvedic group. The conversational and counseling techniques in the Ayurvedic group offered more opportunities for problem description by patients as well as patient-centered practice and resource-oriented recommendations by the physician. Trial Registration: NCT01797887.

Background: We aim to compare the effectiveness of 3 active interventions, i.e., yoga, eurythmy therapy, and physiotherapeutic exercise, on chronic lower back pain. Methods: In this randomized controlled trial over 16 weeks (8 weeks of intervention, 8 weeks of follow-up), data of individuals with chronic lower back pain will be analyzed. Interventions are implemented as group sessions (75 min) once per week. Participants receive a manual for home-based practice and are assessed before and at the end of the 8-week intervention period, and at the end of an 8-week follow-up period. Standardized questionnaires are: the Roland-Morris Disability Score, visual analog scales measuring intensity of pain, the Brief Multidimensional Life Satisfaction Scale, the Perceived Stress Scale, the Inner Correspondence with the Practices questionnaire, the Freiburg Mindfulness Questionnaire, the General Self-Efficacy Scale, a self-regulation questionnaire, the Internal Coherence Scale, a pain diary (registering the need of analgesic medication), and a questionnaire on the patients' expectation that the interventions will be effective in reducing pain and how strong this reduction might be (2 single items), etc. Discussion: This large multicenter study will provide evidence on the effectiveness of 3 contrasting movement-orientated treatments that share some similarities but differ in essential details: yoga, eurythmy therapy, and physiotherapeutic exercises. It will provide important data on non-pharmacological options to treat lower back pain in a large group of affected individuals.

Objective We developed an integrative day care clinic program for cancer patients focusing on mind-body techniques and health-promoting lifestyle modification (7-hour once-per-week group sessions over 12 weeks). Methods A cohort study design with a waiting group was implemented. Outcome parameters were assessed at the beginning, at the end of the active program, and at a 6-month follow-up. Patients waiting >4 and

There is increasing experimental evidence for beneficial effects of calorie restriction and intermittent fasting in type 2 diabetes mellitus (T2DM). In humans, prolonged fasting is established as a health-promoting complementary treatment in Europe and claimed to improve metabolism by a complex hormetic response. We aimed to investigate effects of a one-week fasting period compared to usual care in T2DM by means of a pilot trial. Patients with manifest T2DM medically treated with oral hypoglycemic agents and/or insulin were randomly assigned to a 7-day fasting program followed by dietary advice or to usual care and dietary advice only. Fasting was performed according to the method of Buchinger with a nutritional energy intake of 300kcal/day by liquids only and stepwise re-introduction of solid food thereafter. Outcomes were assessed baseline and after 4 months. Of 46 enrolled participants, 32 (n=16 each group) completed the trial and were included for final analyses. Fasting was well accepted, there were no serious adverse events. After 4 months mean weight decreased by 3.5 kg and 2.0 kg in the fasting vs. control group (p=0.03) paralleled by greater reduction of abdominal circumference (p=0.001). Fasting led to a significant decrease of systolic/diastolic blood pressure (p=0.01; p=0.003) and increased quality-of-life (p=0.04), while for HbA1c, insulin and HOMA-index only non-significant improvements were observed. Results of this study suggest that prolonged fasting is feasible and might have beneficial clinical effects. The effectiveness of fasting should be proved in larger confirmatory trials that include intermittent fasting in follow-ups to enable more pronounced and long-term effects.

Hintergrund: In der vorliegenden Studie wurden die Wirksamkeit und Verträglichkeit des homöopathischen Arzneimittels Sinusitis Hevert SL an Patienten mit akuter Rhinosinusitis untersucht. Methoden: In einer randomisierten, placebokontrollierten klinischen Studie wurden 314 Patienten mit bis zu 3 Tagen bestehenden Symptomen, leichtem bis moderatem Gesichtsschmerz und einem Major Rhinosinusitis Symptom Score (MRSS) ≥ 8 und ≤ 14 für 15 Tage (Tag 0 erster Arztbesuch plus 14 Tage Behandlung) eingeschlossen und mit Sinusitis Hevert SL oder Placebo behandelt. Den primären Endpunkt bildeten die Responderrate im MRSS (Reduktion ≥ 50%) bei der Abschlussvisite sowie die Rate der Remissionen (komplettes Abklingen aller 5 Hauptsymptome). Sekundäre Zielkriterien bildeten die Einschätzung der Wirksamkeit durch den Prüfer (auf einer 4-Punkte-Skala) und der Sino-Nasal Outcome Test 20 German Adapted Version (SNOT-20 GAV; Selbsterhebung durch die Patienten). Ergebnisse: 314 Patienten wurden in die Studie eingeschlossen. Davon wurden 308 mit der Studienmedikation behandelt: 153 mit Sinusitis Hevert SL und 155 mit Placebo. 265 Patienten schlossen die Studie vollständig und valide ab (Valid Completers). Die MRSSpat-Responderrate aller Patienten war für Sinusitis Hevert SL nicht signifikant besser (85,6% vs. 80,6%; p = 0,243), die Rate der Remissionen war mit 31,4% für Sinusitis Hevert SL und 37,4% für Placebo in beiden Gruppen nicht signifikant unterschiedlich (p = 0,2641). In der sekundären Completer-Analyse zeigte sich eine signifikante Differenz der Responderraten von 92,1% versus 83,5% zugunsten von Sinusitis Hevert SL (p = 0,032). Weiter war die Zeit bis zur Verbesserung der Rhinorrhoe signifikant kürzer (4,0 vs. 6,0 Tage; p = 0,040). Vor allem relevante nasale Symptome des SNOT-20 und die Lebensqualität verbesserten sich unter Behandlung mit Sinusitis Hevert SL signifikant deutlicher. Schlussfolgerungen: Es zeigte sich in dieser Studie bei akuter Rhinosinusitis und hoher Placebo-Ansprechrate keine Überlegenheit für Sinusitis Hevert SL in der Gesamtresponder- und Remissionsrate. Es fand sich ein Nutzen von Sinusitis Hevert SL in der Auswertung der Valid Completers für die Response sowie für spezifische Verbesserungen klinisch relevanter Symptome und die Abheilungsgeschwindigkeit der akuten Rhinosinusitis bei guter Verträglichkeit.

This prospective observational trial investigated effects and safety of periodic fasting in subjects with and without type 2 diabetes mellitus (T2DM). The primary end point was set as the change of fatty liver index (FLI) as a surrogate parameter of non-alcoholic fatty liver disease (NAFLD). Six-hundred and ninety-seven subjects (38 with T2DM) were enrolled. A baseline FLI &ge, 60 (the threshold for fatty liver) was found in 264 subjects (37.9%). The mean duration of fasting was 8.5 &plusmn, 4.0 days (range 6&ndash, 38). FLI decreased significantly (&minus, 14.02 &plusmn, 11.67, p &lt, 0.0001), with a larger effect in individuals with T2DM (&minus, 19.15 &plusmn, 11.0, 0.0001, p = 0.002 compared to non-diabetic subjects). Body mass index (BMI) decreased by &minus, 1.51 &plusmn, 0.82 kg/m2, and 49.9% of the subjects lost &ge, 5% body weight. After fasting, nearly half of the 264 subjects with FLI &ge, 60 (highest risk category) shifted to a lower category. The improvement of FLI correlated with the number of fasting days (r = &minus, 0.20, p &lt, 0.0001) and with the magnitude of BMI reduction (r = 0.14, p = 0.0001). Periodic fasting with concomitant weight reduction leads to significant rapid improvement of FLI in subjects with and without T2DM.

Purpose: Apart from organizational issues, quality of inter-professional collaboration during ethical decision-making may affect the intention to leave one’s job. To determine whether ethical climate is associated with the intention to leave after adjustment for country, ICU and clinicians characteristics. Methods: Perceptions of the ethical climate among clinicians working in 68 adult ICUs in 12 European countries and the US were measured using a self-assessment questionnaire, together with job characteristics and intent to leave as a sub-analysis of the Dispropricus study. The validated ethical decision-making climate questionnaire included seven factors: not avoiding decision-making at end-of-life (EOL), mutual respect within the interdisciplinary team, open interdisciplinary reflection, ethical awareness, self-reflective physician leadership, active decision-making at end-of-life by physicians, and involvement of nurses in EOL. Hierarchical mixed effect models were used to assess associations between these factors, and the intent to leave in clinicians within ICUs, within the different countries. Results: Of 3610 nurses and 1137 physicians providing ICU bedside care, 63.1% and 62.9% participated, respectively. Of 2992 participating clinicians, 782 (26.1%) had intent to leave, of which 27% nurses, 24% junior and 22.7% senior physicians. After adjustment for country, ICU and clinicians characteristics, mutual respect OR 0.77 (95% CI 0.66- 0.90), open interdisciplinary reflection (OR 0.73 [95% CI 0.62–0.86]) and not avoiding EOL decisions (OR 0.87 [95% CI 0.77–0.98]) were all associated with a lower intent to leave. Conclusion: This is the first large multicenter study showing an independent association between clinicians’ intent to leave and the quality of the ethical climate in the ICU. Interventions to reduce intent to leave may be most effective when they focus on improving mutual respect, interdisciplinary reflection and active decision-making at EOL., SCOPUS: ar.j, info:eu-repo/semantics/published

ObjectiveTo examine the change in both the prevalence and severity of metabolic syndrome (MetS) in the Sami and non-Sami in Northern Norway due to a lack of knowledge regarding the development of MetS in this population.DesignRepeated cross-sectional study.SettingThe study is based on data from the SAMINOR 1 Survey (2003–2004, n=6550) and the SAMINOR 2 Clinical Survey (2012–2014, n=6004), conducted in 10 municipalities in Northern Norway.ParticipantsMen and women aged 40–79 years were invited. We excluded participants not handing in the questionnaire and with missing information concerning ethnicity questions or MetS risk factors resulting in a final sample of 6308 (36.0% Sami) subjects in SAMINOR 1 and 5866 (40.9% Sami) subjects in SAMINOR 2.Outcome measuresMetS prevalence was determined using the harmonised Adult Treatment Panel III (ATP-III) criteria, and severity was assessed with the MetS severity Z-score. Generalised estimating equations with an interaction term (survey × ethnicity) were used to compare prevalence and severity between the two surveys while accounting for partly repeated measurements.ResultsThe overall, age-standardised ATP-III-MetS prevalence was 31.2% (95% CI: 29.8 to 32.6) in SAMINOR 1 and 35.6% (95% CI: 34.0 to 37.3) in SAMINOR 2. Both the ATP-III-MetS prevalence and the mean MetS severity Z-score increased between the surveys in all subgroups, except the ATP-III-MetS prevalence in non-Sami women, which remained stable. Over time, Sami men showed a slightly larger increase in MetS severity than non-Sami men (pConclusionThe prevalence and severity of MetS increased over time in rural Northern Norway. Abdominal obesity appeared to drive the increase in ATP-III-MetS prevalence. Sami men had a slightly larger increase in severity than non-Sami.

ObjectiveTo describe changes in cardiovascular risk factors and in the estimated 10-year risk of acute myocardial infarction (AMI) or cerebral stroke (CS) between SAMINOR 1 (2003–2004) and SAMINOR 2 (2012–2014), and explore if these changes differed between Sami and non-Sami.DesignTwo cross-sectional surveys.SettingInhabitants of rural Northern Norway.ParticipantsParticipants were aged 40–79 years and participated in SAMINOR 1 (n=6417) and/or SAMINOR 2 (n=5956).Primary outcome measuresGeneralised estimating equation regressions with an interaction term were used to estimate and compare changes in cardiovascular risk factors and 10-year risk of AMI or CS between the two surveys and by ethnicity.ResultsMean cholesterol declined by 0.50, 0.43 and 0.60 mmol/L in women, Sami men and non-Sami men, respectively (all pConclusionsIndependent of ethnicity, there was a decline in mean cholesterol, blood pressure, smoking, hypertension (women only) and 10-year risk of AMI or CS, but waist circumference increased. Relatively minor ethnic differences were found in changes of cardiovascular risk factors.

Objectives To develop an enhanced understanding of factors that influence providers' views about end-of-life care, we examined the contributions of provider, hospital, and country to variability in agreement with consensus statements about end-of-life care. Design and setting Data were drawn from a survey of providers' views on principles of end-of-life care obtained during the consensus process for the Worldwide End-of-Life Practice for Patients in ICUs study. Subjects Participants in Worldwide End-of-Life Practice for Patients in ICUs included physicians, nurses, and other providers. Our sample included 1,068 providers from 178 hospitals and 31 countries. Interventions None. Measurements and main results We examined views on cardiopulmonary resuscitation and withholding/withdrawing life-sustaining treatments, using a three-level linear mixed model of responses from providers within hospitals within countries. Of 1,068 providers from 178 hospitals and 31 countries, 1% strongly disagreed, 7% disagreed, 11% were neutral, 44% agreed, and 36% strongly agreed with declining to offer cardiopulmonary resuscitation when not indicated. Of the total variability in those responses, 98%, 0%, and 2% were explained by differences among providers, hospitals, and countries, respectively. After accounting for provider characteristics and hospital size, the variance partition was similar. Results were similar for withholding/withdrawing life-sustaining treatments. Conclusions Variability in agreement with consensus statements about end-of-life care is related primarily to differences among providers. Acknowledging the primary source of variability may facilitate efforts to achieve consensus and improve decision-making for critically ill patients and their family members at the end of life.

Only few studies document longer periods of fasting in large cohorts including non-obese participants. The aim of this study was to document prospectively the safety and any changes in basic health and well-being indicators during Buchinger periodic fasting within a specialised clinic. In a one-year observational study 1422 subjects participated in a fasting program consisting of fasting periods of between 4 and 21 days. Subjects were grouped in fasting period lengths of 5, 10, 15 and 20±2 days. The participants fasted according to the Buchinger guidelines with a daily caloric intake of 200–250 kcal accompanied by a moderate-intensity lifestyle program. Clinical parameters as well as adverse effects and well-being were documented daily. Blood examinations before and at the end of the fasting period complemented the pre-post analysis using mixed-effects linear models. Significant reductions in weight, abdominal circumference and blood pressure were observed in the whole group (each p

Background Integrative mental health care can be applied to treat depression with a person-centered, lifestyle-modifying, and more salutogenic approach to mental health and human flourishing. In this article, we report on the feasibility and acceptability of a new mind-body program, Meditation Based Lifestyle Modification (MBLM), in outpatients with mild or moderate depression. Methods This is a single-arm mixed-methods feasibility study of n = 25 outpatients in psychiatric care. Depressive symptoms, scores for mindfulness, aspects of spirituality, and eudaemonic well-being based on yoga philosophy were assessed at baseline and at the end of the intervention. Adherence was monitored and face-to-face interviews were held after the program to explore the acceptability and feasibility of MBLM. Results Twenty patients (75 %) completed at least six sessions of the course. Adherence was 87.5 % of allocated sessions. In qualitative analysis, more than half of the participants experienced novelty and inspiration through practicing the ethical aspects of yoga (e.g., nonviolence, truthfulness, etc.). Almost all participants experienced a decrease in emotional distress. Virtually all participants reported more self-confidence and self-acceptance. In quantitative analysis, participants reported a clinically important decrease in depressive symptoms of 39.23 % (p = .002), eudaemonic well-being increased significantly in a range of related scales and scores for mindfulness increased (p Conclusion MBLM is a highly acceptable and feasible program for outpatients with mild to moderate depression. This comprehensive, lifestyle-modifying approach is highly relevant to preventing and treating mental illness, and treating psychic comorbidities in patients with chronic somatic illness.

Research has shown the importance of turning points in desistance from criminal behavior. Using qualitative data from a sample of 100 formerly incarcerated mothers interviewed about their criminal behavior, this article explores their descriptions of transition moments and whether and how those moments affected their criminal behavior. The findings indicate that whereas parenting emerges as a turning point, the practical difficulties of reentry may reduce the impact of mothering on women’s desistance. More self-focused turning points, such as those due to incarceration, arrest, and sobriety appeared to be particularly important to the women’s desistance. This article emphasizes the need for research into the subjective and environmental factors that affect women’s desistance behaviors.

Summary Dietary interventions have not been effective in the treatment of multiple sclerosis (MS). Here, we show that periodic 3-day cycles of a fasting mimicking diet (FMD) are effective in ameliorating demyelination and symptoms in a murine experimental autoimmune encephalomyelitis (EAE) model. The FMD reduced clinical severity in all mice and completely reversed symptoms in 20% of animals. These improvements were associated with increased corticosterone levels and regulatory T (Treg) cell numbers and reduced levels of pro- inflammatory cytokines, TH1 and TH17 cells, and antigen-presenting cells (APCs). Moreover, the FMD promoted oligodendrocyte precursor cell regeneration and remyelination in axons in both EAE and cuprizone MS models, supporting its effects on both suppression of autoimmunity and remyelination. We also report preliminary data suggesting that an FMD or a chronic ketogenic diet are safe, feasible, and potentially effective in the treatment of relapsing-remitting multiple sclerosis (RRMS) patients (NCT01538355).

Objectives We aimed to evaluate the effectiveness of an 8-week meditation program (focused meditation) in patients with chronic low-back pain. Design A randomized clinical trial was conducted on 68 patients (55 years;75% female) with chronic low-back pain who scored >40 mm on a 100 mm Visual-Analogue-Scale. Subjects were allocated to an 8-week meditation program (focused meditation) with weekly 75 min classes or to a self-care exercise program with a wait-list offer for meditation. Both groups were instructed to practice at home. Outcomes were assessed baseline and after 4 and 8 weeks. The primary outcome measure was the change in mean back pain at rest after 8 weeks. Secondary outcomes included function, pain-related bothersomeness, perceived stress, quality-of-life (QOL), and psychological outcomes. Results Twelve (meditation) and 4 (exercise) patients were lost to follow-up. The primary outcome, pain at rest after 8 weeks, was reduced from 59.3 ± 13.9 mm to 40.8 ± 21.8 mm with meditation vs. 52.9 ± 11.8 mm to 37.3 ± 18.2 mm with exercise (adjusted group difference: −1.4 (95%CI:11.6;8.8;p = n.s.) Perceived stress was significantly more reduced with meditation (p = 0.011). No significant treatment effects were found for other secondary outcomes as pain-related bothersomeness, function, quality-of-life and psychological scores, although the meditation group consistently showed non-significant better improvements compared to the exercise group. Conclusions Focused meditation and self-care exercise lead to comparable, symptomatic improvements in patients with chronic low back pain. Future studies should include longer-term follow-ups and develop guided meditation programs to support compliance.

Objectives Distress and stress-related diseases are an increasing public health problem at schools. This qualitative study was nested in a non-randomized, controlled trial studying the effects of a 10-week yoga course as an alternative for regular school sports in two secondary schools in Germany. Methods We conducted a qualitative evaluation in 3 focus groups with 6 participants each. The focus groups were audio-recorded, transcribed verbatim, pseudonymised and analysed using qualitative content analysis. Furthermore open questions were asked in questionnaires. Results The analysis of the participants’ interviews (mean age 19.6 ± 2.9 years, n = 10 female, n = 8 male) resulted in 4 key topics: 1. encountering yoga, 2. yoga practice, 3. effects and benefits of yoga, and 4. yoga in the school context. Yoga was very well accepted by most participants. They reported a variety of physical and psychological benefits as well as overall restorative effects. The relief of pain or other physical ailments, higher mobility and flexibility, improved posture and improved sleep were mentioned by the participants. Some participants used the new exercises and experiences (e.g. working with the breath) in their everyday life. The possibility for self-responsible action was a welcome change from the perceived pressure and heteronomy in normal (school) life. Controversial was the question of whether yoga - if it is part of school sport - should be assessed or graded, and whether it should be compulsory or voluntary. Conclusion Yoga can offer both physical and psychological benefits in young adults as well as offer general regenerative effects. Yoga by sensitizing the participants to negative patterns of behaviour can encourage healthy behaviour.

Objectives Distress is an increasing public health problem for adolescents and young adults. We aimed to evaluate potential effects of a 10-week 90-minute once-a-week yoga course. Methods A non-randomized controlled study with a school sport control group was implemented in two German secondary schools. Primary outcome was stress on the Perceived Stress Scale from baseline to week 10. Secondary outcomes included depression/anxiety, attention, quality of life, mood, visual analogue scales (for pain, headache, neck tension, exhaustion, sleep), and yoga-efficacy. Parameters were assessed at pre-baseline (before holidays), baseline (after 3-week holidays, before interventions started), week 10, and at a 6-months follow-up. An intention-to-treat analysis using ANCOVA was performed. Results 92 participants (67 % female; 19.6 ± 2.2 years) were included into the study. No significant differences were observed between the groups with regard to PSS, at either 10 weeks (Δ=-1.4; 95 % CI: -3.6;0.8; p = 0.22) or 6 months (Δ = 2; 95 % CI: -0.2;4.2, p = 0.08). Only VAS headache in favour of yoga and HADS-D in favour of school sport showed significant group differences at the 6-months follow-up. Significant intra-group mean changes for the primary outcome and several secondary outcomes were found in the yoga group. Conclusions Young adults in German secondary school settings might benefit from yoga, as the found effects were more prominent in the yoga group. However, the effects might be attributed to non-specific effects due to the chosen study design. Further studies are needed, which include high-quality study designs including randomization, longer-term follow-ups and larger sample sizes.

End-of-life care (EOLC) in the intensive care unit (ICU) is becoming increasingly more common but ethical standards are compromised by growing economic pressure. It was previously found that perception of non-beneficial treatment (NBT) was independently associated with the core burnout dimension of emotional exhaustion. It is unknown whether factors of the work environment also play a role in the context of EOLC.Is the working environment associated with perception of NBT or clinician burnout?Physicians and nursing personnel from 11 German ICUs who took part in an international, longitudinal prospective observational study on EOLC in 2015-2016 were surveyed using validated instruments. Risk factors were obtained by multivariate multilevel analysis.The participation rate was 49.8% of personnel working in the ICU at the time of the survey. Overall, 325 nursing personnel, 91 residents and 26 consulting physicians participated. Nurses perceived NBT more frequently than physicians. Predictors for the perception of NBT were profession, collaboration in the EOLC context, excessively high workload (each p ≤ 0.001) and the numbers of weekend working days per month (p = 0.012). Protective factors against burnout included intensive care specialization (p = 0.001) and emotional support within the team (p ≤ 0.001), while emotional exhaustion through contact with relatives at the end of life and a high workload were both increased (each p ≤ 0.001).Using the example of EOLC, deficits in the work environment and stress factors were uncovered. Factors of the work environment are associated with perceived NBT. To reduce NBT and burnout, the quality of the work environment should be improved and intensive care specialization and emotional support within the team enhanced. Interprofessional decision-making among the ICU team and interprofessional collaboration should be improved by regular joint rounds and interprofessional case discussions. Mitigating stressful factors such as communication with relatives and high workload require allocation of respective resources.

Background This pilot trial aimed to study the feasibility and effects on quality of life (QOL) and well-being of short-term fasting (STF) during chemotherapy in patients with gynecological cancer. Methods In an individually-randomized cross-over trial patients with gynecological cancer, 4 to 6 planned chemotherapy cycles were included. Thirty-four patients were randomized to STF in the first half of chemotherapies followed by normocaloric diet (group A;n = 18) or vice versa (group B;n = 16). Fasting started 36 h before and ended 24 h after chemotherapy (60 h-fasting period). QOL was assessed by the FACIT-measurement system. Results The chemotherapy-induced reduction of QOL was less than the Minimally Important Difference (MID; FACT-G = 5) with STF but greater than the MID for non-fasted periods. The mean chemotherapy-induced deterioration of total FACIT-F was 10.4 ± 5.3 for fasted and 27.0 ± 6.3 for non-fasted cycles in group A and 14.1 ± 5.6 for non-fasted and 11.0 ± 5.6 for fasted cycles in group B. There were no serious adverse effects. Conclusion STF during chemotherapy is well tolerated and appears to improve QOL and fatigue during chemotherapy. Larger studies should prove the effect of STF as an adjunct to chemotherapy. Trial registration This trial was registered at clinicaltrials.gov: NCT01954836.

Background A randomised, placebo-controlled clinical trial in children suffering from acute dry cough was performed to assess the efficacy and tolerability of a complex homeopathic drug (Drosera, Coccus cacti, Cuprum Sulfuricum, Ipecacuanha=Monapax syrup, short: verum). Methods 89 children received verum and 91 received placebo daily for 7 days (age groups 0.5–3, 4–7 and 8–12 years). The primary efficacy variable was the improvement of the Cough Assessment Score. Tolerability and compliance were also assessed. A confirmatory statistical analysis was performed for the primary efficacy variable and a descriptive analysis for the secondary parameters. Results The Cough Assessment Score showed an improvement of 5.2±2.6 points for children treated with verum and 3.2±2.6 points in the placebo group (p Conclusions Administering verum resulted in a statistically significantly greater improvement of the Cough Assessment Score than the placebo. The tolerability was good and not inferior to that of the placebo.

Background: Treatment of female infertility has been growing globally in recent years. In spite of improvements in medical strategies and the improved outcomes for infertile couples, treatment attempts remain largely unsuccessful. A growing number of patients pursue complementary and alternative medicine treatment options like Ayurveda that offers a variety of inpatient and outpatient treatments for infertility. Case Report: A case of a 38 year-old woman with infertility of unknown origin is presented. She received 18 conventional fertility treatments in 5 different fertility centers and 3 different countries. After several complications, the patient quitted conventional treatment and admitted to an Ayurvedic outpatient clinic where she received a complex Ayurvedic treatment, which included botanicals, dietary and lifestyle advice, manual therapy, yoga, and spiritual elements. The patient then became pregnant and gave birth to a healthy boy in 2012. Conclusions: Ayurveda may be a useful complementary option in the case of futile conventional treatment attempts in female infertility. Nevertheless, the evidence base for Ayurvedic interventions remains weak and requires well-designed clinical trials. This case raises some questions, such as whether the exposure to a large number of assisted reproduction procedures can lead to more health problems than health benefits. The Ayurvedic approach to fertility strives first to improve the health of the patient leading to a higher likelihood of pregnancy. As this is a case report, we are not able to exclude temporal factors stimulating the pregnancy. However, the chronology suggests that this approach might have been an important factor in the eventual pregnancy.

Background/aim Exposure of the skin to sunshine is the major natural source of vitamin D. In order to imitate this natural production of vitamin D for patients with chronic kidney disease, hemodialysis patients were exposed three times a week to radiation of the front part of both legs to normalize the vitamin D status. Patients and methods Partial body UVB irradiation was performed during the routine dialysis session. Twenty-two patients took part, with a mean age of 61.7 (range=35-81) years. Results Serum levels of 25(OH)D3 and 1,25(OH)2D3 increased into the mid normal range. Intact parathyroid hormone decreased by 25% and osteocalcin by 45%. 24-Hour blood-pressure monitoring demonstrated decreases in systolic and diastolic blood pressure. Conclusion Partial body exposure to UVB radiation normalized not only the serum level of 25(OH)D3, but also that of 1,25(OH)2D3, which resulted in a significant decrease in parathyroid hormone, osteocalcin levels, and also in blood pressure. Sunshine imitating UVB exposure utilizes the capacity of the skin to convert extrarenally vitamin D3 to 25(OH)D3 and 1,25(OH)2D3.

Objective The aim of the study was to evaluate whether intermittent fasting (IF) is an effective preventive measure, and whether it is feasible for healthy volunteers under every day conditions. Methods A nonrandomized controlled clinical trial on IF was performed with healthy volunteers over a period of 8 wk, and a subsequent 4-mo follow-up. Outcomes were assessed at baseline, after 8 wk, and after 6 mo. Volunteers who were not interested in fasting served as a control group. Participants in the fasting group were asked to continue their regular nutritional habits on the nonfasting days, whereas the control group maintained their habitual nutrition throughout the whole period. Outcomes included changes of metabolic parameters (insulin, glucose, insulin resistance, insulin-like growth factor-1, brain-derived neurotropic factor, lipids, liver enzymes, hemoglobin A1c) and coagulation markers; bioelectrical impedance analysis; body mass index; abdominal girth; blood pressure; general quality of life (five-item World Health Organization Well-Being Index [WHO-5] questionnaire), as well as mood and anxiety (Hospital Anxiety and Depression Scale [HADS], Profile of Mood States, Flourishing-Scale, visual analog scale, Likert scales). The intervention consisted of a fasting day, which was repeated every week for 8 wk, with abstinence from solid food between 00:00 and 23:59 at minimum and a maximum caloric intake of 300 kcal on each fasting day. A per-protocol analysis was performed. P Results Thirty-six volunteers were included; 22 allocated themselves to the fasting group, and 14 to the control group. Thirty-three data sets were included in the final analysis. Although significant in-group changes were observed in both groups for a number of outcomes after 8 wk and 6 mo, no significant between-group differences were observed for any outcome other than overall body fat mass after 8 wk as well as for the HADS total score and the WHO-5 total score after 6 mo, all in favor of the fasting group. However, none of the between-group differences were clinically relevant. Conclusions We did not find any clinically relevant differences between groups in this controlled clinical pilot trial of 8 wk of IF in healthy volunteers. Further clinical research in this field is warranted to further analyze mechanisms and effects of IF.

Calorie restriction or changes in dietary composition can enhance healthy aging, but the inability of most subjects to adhere to chronic and extreme diets, as well as potentially adverse effects, limits their application. We randomized 100 generally healthy participants from the United States into two study arms and tested the effects of a fasting-mimicking diet (FMD)—low in calories, sugars, and protein but high in unsaturated fats—on markers/risk factors associated with aging and age-related diseases. We compared subjects who followed 3 months of an unrestricted diet to subjects who consumed the FMD for 5 consecutive days per month for 3 months. Three FMD cycles reduced body weight, trunk, and total body fat; lowered blood pressure; and decreased insulin-like growth factor 1 (IGF-1). No serious adverse effects were reported. After 3 months, control diet subjects were crossed over to the FMD program, resulting in a total of 71 subjects completing three FMD cycles. A post hoc analysis of subjects from both FMD arms showed that body mass index, blood pressure, fasting glucose, IGF-1, triglycerides, total and low-density lipoprotein cholesterol, and C-reactive protein were more beneficially affected in participants at risk for disease than in subjects who were not at risk. Thus, cycles of a 5-day FMD are safe, feasible, and effective in reducing markers/risk factors for aging and age-related diseases. Larger studies in patients with diagnosed diseases or selected on the basis of risk factors are warranted to confirm the effect of the FMD on disease prevention and treatment.

© 2014 American Academy of Pain Medicine 15 11 November 2014 10.1111/pme.12534 SPINE SECTION Original Research Articles Original Research Article Wiley Periodicals, Inc. Objective: This analysis aimed to determine reliability, validity, and responsiveness of the pain on movement (POM) questionnaire, an instrument developed to determine pain intensity induced by head movement. Design: Data from nine randomized controlled trials for the treatment of chronic nonspecific neck pain were reanalyzed to determine reliability and validity of the POM questionnaire. Methods: POM was assessed as ratings of pain intensity induced by head movement in six different directions. The instrument's structure was assessed using a factor analysis. Reliability (internal consistency) was determined using Cronbach's alpha, and validity (convergent validity) was determined by correlating the POM with pain at rest on a visual analog scale (VAS), the neck disability index (NDI), quality of life (short-form 36 health survey questionnaire [SF-36]) and range of motion. Responsiveness was indicated by sensitivity to changes over time in a subsample of 49 patients. Results: Overall, 482 patients (mean age 50.3±12.4 years, 72.3% female) were included in the analysis, and 458 of them provided complete data set for the POM. Average POM was 43.9±20.8mm on the VAS. The POM showed very good reliability as indicated by high internal consistency and moderate validity as indicated by significant correlations with the pain at rest, the NDI, and the SF-36. No correlations were found for POM with range of motion. The POM further proved to be responsive as it was sensitive to changes over time, and those changes were correlated to changes in pain intensity and NDI. Conclusions: The POM seems to be a reliable and valid instrument to assess POM in patients with chronic nonspecific neck pain.

We intended to analyze whether patients with chronic diseases believe in guardian angels (GdA) as a coping resource. In a cross-sectional survey, we analyzed data from 576 German patients with chronic diseases (mean age 51.3 ± 15.4 years). We found that 56 % of the patients often or even regularly believed in GdA, with significantly more women than men believing. Particularly interesting was the fact that 38 % of patients who were identified as neither religious nor spiritual (R-S-) believed in GdAs. This belief may indicate that patients are interested in bridging the gap between the concrete struggle to manage illness and non-rational/transcendent realms.

OBJECTIVES: Chronic neck pain is a significant public health problem with only very few evidence-based treatment options. There is growing evidence for the effectiveness of yoga for relieving musculoskeletal disorders. The aim of this study was to evaluate the effect of Iyengar yoga compared with exercise on chronic nonspecific neck pain. METHODS: Patients were randomly assigned to either yoga or exercise. The yoga group attended a 9-week yoga course and the exercise group received a self-care manual on home-based exercises for neck pain relief. The main outcome measure was the present neck pain intensity (100 mm visual analog scale). Secondary outcome measures included functional disability (Neck Disability Index), pain at motion (visual analog scale), health-related quality of life (Short Form-36 questionnaire), cervical range of motion, proprioceptive acuity, and pressure pain threshold. RESULTS: Fifty-one patients (mean age 47.8 y; 82.4% female) were randomized to yoga (n=25) and exercise (n=26) intervention. After the study period, patients in the yoga group reported significantly less neck pain intensity compared with the exercise group [mean difference:-13.9 mm (95% CI,-26.4 to-1.4), P=0.03]. The yoga group reported less disability and better mental quality of life. Range of motion and proprioceptive acuity were improved and the pressure pain threshold was elevated in the yoga group. DISCUSSION: Yoga was more effective in relieving chronic nonspecific neck pain than a home-based exercise program. Yoga reduced neck pain intensity and disability and improved health-related quality of life. Moreover, yoga seems to influence the functional status of neck muscles, as indicated by improvement of physiological measures of neck pain. Copyright © 2012 by Lippincott Williams &Wilkins.

Ayurveda is one of the oldest comprehensive healthcare systems worldwide. Ayurvedic massage and physical therapy are frequently used to treat patients with chronic pain syndromes and disorders of the musculoskeletal system. This study aimed to evaluate the effectiveness of Ayurvedic massage in nonspecific chronic low back pain by means of a randomized clinical trial.Sixty-four patients (mean age, 54.8 years; 49 women and 15 men) with chronic low back pain who scored40 mm on a 100-mm visual analogue scale (VAS) were randomly assigned to a 2-week massage group with 6 hours of Ayurvedic massage and external treatment (n = 32) or to a 2-week local thermal therapy group (n = 32). The study observation period was 4 weeks, consisting of a 2-week intervention phase followed by a 2-week follow-up phase.Primary outcome measure was the change of mean pain (VAS) from baseline to week 4. Secondary outcomes included pain-related bothersomeness, the Roland Disability Questionnaire, quality of life (Medical Outcomes Study 36-Item Short Form), the Hanover Functional Ability Questionnaire for measuring back pain-related disability, and psychological outcomes. Outcomes were assessed at baseline and after 2 and 4 weeks.Mean back pain (primary outcome) at week 2 was significantly reduced from 53.4 ± 18.5 to 21.6 ± 18.2 in the massage group and from 55.3 ± 12.9 to 41.8 ± 19.8 in the standard thermal therapy group (mean group difference, -18.7; 95% confidence interval, -28.7 to -8.7; p 0.001). While beneficial effects on pain-related bothersomeness and psychological well-being were also apparent, the Ayurvedic intervention did not improve function or disability in the short-term observation period. Both programs were safe and well tolerated.Ayurvedic external treatment is effective for pain-relief in chronic low back pain in the short term. Further studies with longer observation periods are needed to evaluate the long-term effects of the Ayurvedic external treatment approach on function and disability.

Background: Vegetarian nutrition is gaining increasing public attention worldwide. While some studies have examined differences in motivations and personality traits between vegetarians and omnivores, only few studies have considered differences in motivations and personality traits between the 2 largest vegetarian subgroups: lacto-ovo-vegetarians and vegans. Objectives: To examine differences between lacto-ovo-vegetarians and vegans in the distribution patterns of motives, values, empathy, and personality profiles. Methods: An anonymous online survey was performed in January 2014. Group differences between vegetarians and vegans in their initial motives for the choice of nutritional approaches, health-related quality of life (World Health Organization Quality of Life-BREF (WHOQOL-BREF)), personality traits (Big Five Inventory-SOEP (BFI-S)), values (Portraits Value Questionnaire (PVQ)), and empathy (Empathizing Scale) were analyzed by univariate analyses of covariance; P values were adjusted for multiple testing. Results: 10,184 individuals completed the survey; 4,427 (43.5%) were vegetarians and 4,822 (47.3%) were vegans. Regarding the initial motives for the choice of nutritional approaches, vegans rated food taste, love of animals, and global/humanitarian reasons as more important, and the influence of their social environment as less important than did vegetarians. Compared to vegetarians, vegans had higher values on physical, psychological, and social quality of life on the WHOQOL-BREF, and scored lower on neuroticism and higher on openness on the BFI-S. In the PVQ, vegans scored lower than vegetarians on power/might, achievement, safety, conformity, and tradition and higher on self-determination and universalism. Vegans had higher empathy than vegetarians (all p < 0.001). Discussion: This survey suggests that vegans have more open and compatible personality traits, are more universalistic, empathic, and ethically oriented, and have a slightly higher quality of life when compared to vegetarians. Given the small absolute size of these differences, further research is needed to evaluate whether these group differences are relevant in everyday life and can be confirmed in other populations.

Objective: To test the efficacy of the Alexander Technique, local heat and guided imagery on pain and quality of life in patients with chronic non-specific neck pain. Design: A randomized controlled trial with 3 parallel groups was conducted. Setting: Outpatient clinic, Department of Internal and Integrative Medicine. Subjects: A total of 72 patients (65 females, 40.7±7.9 years) with chronic non-specific neck pain. Interventions: Patients received 5 sessions of the Alexander Technique - an educational method which aims to modify dysfunctional posture, movement and thinking patterns associated with musculoskeletal disorders. Control groups were treated with local heat application or guided imagery. All interventions were conducted once a week for 45 minutes each. Main measures: The primary outcome measure at week 5 was neck pain intensity on a 100-mm visual analogue scale; secondary outcomes included neck disability, quality of life, satisfaction and safety. Statistics: Analyses of covariance were applied; testing ordered hypotheses. Results: No group difference was found for pain intensity for the Alexander Technique compared to local heat (difference 4.5mm; 95%CI:-8.1;17.1;p=0.48), but exploratory analysis revealed the superiority of the Alexander Technique over guided imagery (difference -12.9mm; 95%CI:-22.6;-3.1,p=0.01). Significant group differences in favor of the Alexander Technique were also found for physical quality of life ( PConclusion: The Alexander Technique was not superior to local heat application in treating chronic non-specific neck pain. It cannot be recommended as routine intervention at this time. Further trials are warranted for conclusive judgment.

Acupuncture has been shown to exhibit distinct effects on the autonomic nervous system. We tested whether the autonomic and psychological response to acupuncture depends on the stimulation dose and the personality of the treated subjects. 52 healthy subjects were randomized to receive either low dose (one needle at point Hegu bilaterally) or high dose (additional 4 needles at non-acupoints bilaterally) acupuncture stimulation after stratification according to their personality to "reduce" or "augment" incoming stimuli. Outcomes were changes of electrodermal activity (EDA), high frequency component of heart rate variability, heart rate, mean arterial blood pressure, respiration rate and subjective parameters for psychological well being and perceived intensity of needling. Electrodermal activity increased during needle insertion and decreased under baseline when subjects were resting with the needles in the body for 20 min. The initial EDA increase was significantly (GEE ANCOVA p0.001) more pronounced during high dose stimulation and independent of personality. All other physiological parameters did not show any significant group effect. Strong stimulated augmenters perceived acupuncture most painful and increased with their psychological activation after the acupuncture session in contrast to the other groups, which showed a decrease of activation in the pre-post comparison (overall group effect p=0.032). The data indicate that during needle insertion high dose acupuncture stimulation leads to a higher increase of sympathetic nerve activity than low dose stimulation independent of personality. After needle insertion subjects who tend to augment incoming stimuli might show a lack of psychological relaxation when receiving high dose stimulation.

o-Quinone forming estrogens and selective estrogen receptor modulators (SERMs) have been associated with carcinogenesis. LY2066948, a novel SERM in development by Eli Lilly for the treatment of uterine fibroids and myomas, has structural similarity to the equine estrogen equilenin present in hormone replacement formulations; both contain a naphthol group susceptible to oxidative metabolism to o-quinones. LY2066948 was synthesized and assayed for antiestrogenic activity, and in cell culture was confirmed to be a more potent antiestrogen than the prototypical SERM, 4-hydroxytamoxifen. Oxidation of LY2066948 with 2-iodoxybenzoic acid gave an o-quinone (t1/2 = 3.9 ± 0.1 h) which like 4-hydroxyequilenin-o-quinone (t1/2 = 2.5 ± 0.2 h) was observed to be exceptionally long-lived with the potential to cause cytotoxicity and/or genotoxicity. In model reactions with tyrosinase, the catechol metabolites of LY2066948 and equilenin were products; interestingly, in the presence of ascorbate to inhibit autoxidation, these catechols were formed quantitatively. Tyrosinase incubations in the presence of GSH gave the expected GSH conjugates resulting from trapping of the o-quinones, which were characterized by LC-MS/MS. Incubations of LY2066948 or equilenin with rat liver microsomes also gave detectable o-quinone trapped GSH conjugates; however, as observed with other SERMs, oxidative metabolism of LY2066948 mainly occurred on the amino side chain to yield the N-dealkylated metabolite. CYP1B1 is believed to be responsible for extra-hepatic generation of genotoxic estrogen quinones and o-quinone GSH conjugates were detected in equilenin incubations. However, in corresponding incubations with CYP1B1 supersomes, noo-quinone GSH conjugates of LY2066948 were detected. These studies suggest that although the naphthol group is susceptible to oxidative metabolism to long-lived o-quinones, the formation of these quinones by cytochrome P450 can be attenuated by the chemistry of the remainder of the molecule as in the case of LY2066948.

External application of clay facial masks is a cosmetic procedure generally used to reduce skin lesions and to improve overall skin condition.Collecting pilot data about self-treatment with clay jojoba oil masks on participants with acne-prone, lesioned skin and acne.Open, prospective, observational pilot study: Participants received written information, instructions, and questionnaires without direct contact with the study physician. For 6 weeks, they applied the masks 2-3 times per week. The primary outcome is the difference of skin lesions: baseline vs. after 6 weeks.194 participants (192 female, 2 male, mean age (± SE) (32.3 ± 0.7 years) returned questionnaires and diaries. 133 of these participants returned complete and precise lesion counts (per-protocol (PP) collective). A 54% mean reduction in total lesion count was observed after 6 weeks of treatment with clay facial mask. Both inflammatory and non-inflammatory skin lesions were reduced significantly after treatment compared to baseline: Median counts (MC) of pustules per affected participant were reduced from 7.0 ± 0.9 to 3.0 ± 0.5 (mean individual reduction (MIR) = 49.4%), the MC of the papules from 3.5 ± 2.2 to 1.0 ± 0.4 (MIR = 57.3%), the MC of cysts from 2.0 ± 0.8 to 0.5 ± 0.4 (MIR = 68.6%) and the MC of comedones from 26.5 ± 6.3 to 16.0 ± 4.0 (MIR = 39.1%). DLQI-average score decreased from 5.0 ± 4.5 (mean ± SE) before to 2.1 ± 2.8 after treatment.The present study gives preliminary evidence that healing clay jojoba oil facial masks can be effective treatment for lesioned skin and mild acne vulgaris.

ObjectiveTo evaluate the effects of the modified Linggui Zhugan Decoction () combined with short-term very low calorie diets (VLCDs) on glycemic control in newly diagnosed type 2 diabetes mellitus (T2DM) patients.MethodsA total of 20 subjects with newly diagnosed T2DM were treated with the modified Linggui Zhugan Decoction (one-month administration) combined with short-term VLCDs (5 days), and 3-months follow-up. A standard 75-g oral-glucose-tolerance test (OGTT) indexes fasting plasma glucose (FPG), post-prandial 0.5 h and 2 h plasma glucose (P0.5hPG, P2hPG), glycated hemoglobin A1C (GHbA1C), body weight, body mass index (BMI), insulin function, insulin resistance index, incidence of hypoglycemia, and the liver and renal functions were evaluated before and after treatment. Correlations of BMI with insulin function and insulin resistance were also assessed.ResultsAfter the treatment, the patients' plasma glucose decreased steadily, FPG decreased from 5.8±0.9 mmol/L at pre-treatment to 5.0±0.6 mmol/L at 3-months follow-up (P < 0.05), and P2hPG decreased from 11.7±3.8 mmol/L at pre-treatment to 6.9±0.9 mmol/L at 3-months follow-up (P < 0.01). The level of GHbA1C declined from (6.47±1.24)% at pre-treatment to (6.14±0.99)% at 3-months follow-up (P < 0.01). Body weight and BMI also declined significantly. Insulin resistance index was improved obviously and no event of hypoglycemia occurred. Part of the patients companied with fatty liver had a transient increase in hepatic transaminase during the treatment, but it turned to normal after the treatment.ConclusionsThe modified Linggui Zhugan Decoction combined with short-term VLCDs can be safely implemented for steady glycemic control in newly diagnosed T2DM patients.

Objective. Gua sha is a traditional East Asian healing technique where the body surface is press-stroked with a smooth-edged instrument to intentionally raise therapeutic petechiae. A traditional indication of Gua sha is neck pain; no data from controlled trials exist to support this claim. The researchers aimed to investigate the effectiveness of Gua sha in the symptomatic treatment of chronic neck pain. Design. The study was designed as an open randomized controlled clinical trial. Setting. The study was set in Kliniken Essen-Mitte, Academic Teaching Hospital of the University Duisburg-Essen, Germany. Subjects. Forty-eight outpatients (58.5 ± 8.0 years; 41 female) with chronic mechanical neck pain were the subjects of the study. Intervention. Patients were randomized into Gua sha (N = 24) or control groups (N = 24) and followed up for 7 days. Gua sha patients were treated once with Gua sha, while control patients were treated with a local thermal heat pad. Outcome Measures. Primary outcome was change of neck pain severity after 1 week as assessed by visual analog scale. Secondary outcomes included pain at motion, the neck disability index (NDI) and quality-of-life (Short-Form [36] Health Survey). Results. Neck pain severity after 1 week improved significantly better in the Gua sha group compared with the control group (group difference −29.9 mm, 95% confidence interval: −43.3; −16.6 mm; P < 0.001). Significant treatment effects were also found for pain at motion, scores on the NDI, and dimensions of quality-of-life. The treatment was safe and well tolerated. Conclusion. Gua sha has beneficial short-term effects on pain and functional status in patients with chronic neck pain. The value of Gua sha in the long-term management of neck pain and related mechanisms remains to be clarified.