Effects of Prolonged Medical Fasting during an Inpatient, Multimodal, Nature-Based Treatment on Pain, Physical Function, and Psychometric Parameters in Patients with Fibromyalgia: An Observational Study.

Fibromyalgia syndrome (FMS) is a common chronic pain disorder and often occurs as a concomitant disease in rheumatological diseases. Managing FMS takes a complex approach and often involves various non-pharmacological therapies. Fasting interventions have not been in the focus of research until recently, but preliminary data have shown effects on short- and medium-term pain as well as on physical and psychosomatic outcomes in different chronic pain disorders. This single-arm observational study investigated the effects of prolonged fasting (3-12 days, <600 kcal/d) embedded in a multimodal treatment setting on inpatients with FMS. Patients who were treated at the Department of Internal Medicine and Nature-Based Therapies of the Immanuel Hospital Berlin, Germany, between 02/2018 and 12/2020 answered questionnaires at hospital admission (V0) and discharge (V1), and then again three (V2), six (V3), and 12 (V4) months later. Selected routine blood and anthropometric parameters were also assessed during the inpatient stay. A total of 176 patients with FMS were included in the study. The Fibromyalgia Impact Questionnaire (FIQ) total score dropped by 13.7 ± 13.9 (p < 0.001) by V1, suggesting an improvement in subjective disease impact. Pain (NRS: reduction by 1.1 ± 2.5 in V1, p < 0.001) and quality of life (WHO-5: +4.9 ± 12.3 in V1, p < 0.001) improved, with a sustainable effect across follow-up visits. In contrast, mindfulness (MAAS: +0.3 ± 0.7 in V1, p < 0.001), anxiety (HADS-A: reduction by 2.9 ± 3.5 in V1, p < 0.0001), and depression (HADS-D: reduction by 2.7 ± 3.0 in V1, p < 0.0001) improved during inpatient treatment, without longer-lasting effects thereafter. During the study period, no serious adverse events were reported. The results suggest that patients with FMS can profit from a prolonged therapeutic fasting intervention integrated into a complex multimodal inpatient treatment in terms of quality of life, pain, and disease-specific functional parameters. ClinicalTrials.gov Identifier: NCT03785197.

Effects of Prolonged Fasting during Inpatient Multimodal Treatment on Pain and Functional Parameters in Knee and Hip Osteoarthritis: A Prospective Exploratory Observational Study.

Preliminary clinical data suggest that pain reduction through fasting may be effective for different diagnoses. This uncontrolled observational clinical study examined the effects of prolonged modified fasting on pain and functional parameters in hip and knee osteoarthritis. Patients admitted to the inpatient department of Internal Medicine and Nature-based Therapies of the Immanuel Hospital Berlin between February 2018 and December 2020 answered questionnaires at the beginning and end of inpatient treatment, as well as at 3, 6, and 12 months after discharge. Additionally, selected blood and anthropometric parameters, as well as subjective pain ratings, were routinely assessed during the inpatient stay. Fasting was the only common intervention for all patients, being performed as part of a multimodal integrative treatment program, with a daily caloric intake of <600 kcal for 7.7 ± 1.7 days. N = 125 consecutive patients were included. The results revealed an amelioration of overall symptomatology (WOMAC Index score: -14.8 ± 13.31; p < 0.001; d = 0.78) and pain alleviation (NRS Pain: -2.7 ± 1.98, p < 0.001, d = 1.48). Pain medication was reduced, stopped, or replaced by herbal remedies in 36% of patients. Improvements were also observed in secondary outcome parameters, including increased quality of life (WHO-5: +4.5 ± 4.94, p < 0.001, d = 0.94), reduced anxiety (HADS-A: -2.1 ± 2.91, p < 0001, d = 0.55) and depression (HADS-D: -2.3 ± 3.01, p < 0.001, d = 0.65), and decreases in body weight (-3.6 kg ± 1.65, p < 0.001, d = 0.21) and blood pressure (systolic: -6.2 ± 15.93, p < 0.001, d = 0.43; diastolic: -3.7 ± 10.55, p < 0.001, d = 0.43). The results suggest that patients with osteoarthritis of the lower extremities may benefit from prolonged fasting as part of a multimodal integrative treatment to improve quality of life, pain, and disease-specific functional parameters. Confirmatory randomized controlled trials are warranted to further investigate these hypotheses.

Knowledge, Attitudes and Application of Critical Nutrient Supplementation in Vegan Diets among Healthcare Professionals-Survey Results from a Medical Congress on Plant-Based Nutrition.

Plant-based diets are associated with numerous health benefits but also bear risks of micronutrient deficiencies if inadequately planned. The risk of nutrient deficiencies can be reliably reduced by supplementation but requires risk-awareness. We distributed a paper-and-pencil questionnaire to n = 902 healthcare professionals attending a congress on plant-based nutrition (VegMed 2018, Berlin). On the day of the survey (21 April 2018), n = 475 questionnaires were returned and analyzed descriptively. Of the n = 213 strict vegan participants, 2% (n = 5) took no supplements at all. All supplementing vegans reported taking vitamin B12. Almost three-quarters of vegans (73%, n = 152) took vitamin D, and 22% (n = 45) reported taking omega-3 fatty acids. Iron was supplemented by 13% (n = 28), iodine by 12% (n = 25), calcium by 11% (n = 22), zinc by 7% (n = 14), magnesium by 5% (n = 11), and selenium by 4% (n = 9). For 11%, a supplement other than vitamin B12 was subjectively most important. Nearly 50% had their vitamin B12 levels laboratory tested at least once a year; nearly one-quarter reported testing every two years, and another one-quarter rarely or never. Participants following a vegan diet were better informed about institutional recommendations of the German Nutrition Society and the Academy of Nutrition and Dietetics for vegan diets than participants following vegetarian or omnivorous diets. Vegan nutrition in pregnancy/lactation period and childhood was considered most appropriate by vegans. Despite a high awareness of potential health risks associated with vitamin B12 deficiency on a strict vegan diet and a comprehensive understanding of the official dietary recommendations of nutrition societies, use of supplements and performance of regular laboratory tests were only moderate among vegan healthcare professionals. Considering the paramount importance of adequate supplementation of critical nutrients to avoid nutrient deficiencies, scientific and public discourse should be further facilitated. Further investigation of the supplementation behavior of vegan health professionals could be of particular interest, as a possible correlation with the quality of their own nutrition counseling is not inconceivable.

Stress Reduction by Yoga versus Mindfulness Training in Adults Suffering from Distress: A Three-Armed Randomized Controlled Trial including Qualitative Interviews (RELAX Study).

Distress is a growing public health concern. In this three-armed randomized controlled trial, n = 102 adults with elevated stress levels and stress-related symptoms were randomly assigned to (1) "integrative" yoga classes which combined physical exercises, mindfulness training, and ethical/philosophical aspects of traditional yoga; to (2) Iyengar yoga classes which entailed primarily physical exercises; or to (3) mindfulness training without physical training. We hypothesized the synergistic effects of physical yoga exercises, mindfulness, and ethical/philosophical aspects. The primary outcome was the group difference on Cohen's Perceived Stress Scale (PSS) after 12 weeks. Secondary outcomes included burnout, quality of life, physical complaints, depression, anxiety, mindfulness, interoceptive awareness, self-regulation, spirituality, mysticism, and posttraumatic stress. All outcomes were evaluated at baseline (V0), after 12 weeks (V1), and after 24 weeks (V2). A subset of participants took part in qualitative interviews. A lasting and clinically relevant stress reduction was observed within all groups (PSS ΔV0−V1Integrative Yoga = −6.69 ± 6.19; ΔV0−V1Iyengar Yoga = −6.00 ± 7.37; ΔV0−V1Mindfulness = −9.74 ± 7.80; all p < 0.00). Effect sizes were also statistically large at the end of the follow-up period (Cohen's d Integrative Yoga = 1.41; d Iyengar Yoga = 1.37; d Mindfulness = 1.23). There were no significant group differences or evidence of relevant synergistic effects from combining mindfulness and physical yoga exercises. All three interventions were found to be equally effective methods of stress reduction. Their use in practice should be based on availability and patient preference.

A Randomized Controlled Trial of Fasting and Lifestyle Modification in Patients with Metabolic Syndrome: Effects on Patient-Reported Outcomes.

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.

Effects of Fasting and Lifestyle Modification in Patients with Metabolic Syndrome: A Randomized Controlled Trial.

BACKGROUND: Lifestyle interventions, such as fasting, diet, and exercise, are increasingly used as a treatment option for patients with metabolic syndrome (MS). This study assesses the efficacy and safety of fasting followed by lifestyle modification in patients with MS compared to lifestyle modification only. METHODS: Single-blind, multicenter, parallel, randomized controlled trial in two German tertiary referral hospitals in metropolitan areas. INTERVENTIONS: (a) 5-day fasting followed by 10 weeks of lifestyle modification (modified DASH diet, exercise, mindfulness; n = 73); (b) 10 weeks of lifestyle modification only (n = 72). MAIN OUTCOMES AND MEASURES: Co-primary outcomes were ambulatory systolic blood pressure and the homeostasis model assessment (HOMA) index at week 12. Further outcomes included anthropometric, laboratory parameters, and the PROCAM score at weeks 1, 12, and 24. RESULTS: A total of 145 patients with metabolic syndrome (62.8% women; 59.7 ± 9.3 years) were included. No significant group differences occurred for the co-primary outcomes at week 12. However, compared to lifestyle modification only, fasting significantly reduced HOMA index (Δ = -0.8; 95% confidence interval [CI] = -1.7, -0.1), diastolic blood pressure (Δ = -4.8; 95% CI = -5.5, -4.1), BMI (Δ = -1.7; 95% CI = -2.0, -1.4), weight (Δ = -1.7; 95% CI = -2.0, -1.4), waist circumference (Δ = -2.6; 95% CI = -5.0, -0.2), glucose (Δ = -10.3; 95% CI = -19.0, -1.6), insulin (Δ = -2.9; 95% CI = -5.3, -0.4), HbA1c (Δ = -0.2; 95% CI = -0.4, -0.05;), triglycerides (Δ = -48.9; 95% CI = -81.0, -16.9), IL-6 (Δ = -1.2; 95% CI = -2.5, -0.005), and the 10-year risk of acute coronary events (Δ = -4.9; 95% CI = -9.5, -0.4) after week 1. Fasting increased uric acid levels (Δ = 1.0; 95% CI = 0.1, 1.9) and slightly reduced eGRF (Δ = -11.9; 95% CI = -21.8, -2.0). Group differences at week 24 were found for weight (Δ = -2, 7; 95% CI = -4.8, -0.5), BMI (Δ = -1.0; 95% CI = -1.8, -0.3), glucose (Δ = -7.7; 95% CI = -13.5, -1.8), HDL (Δ = 5.1; 95% CI = 1.5, 8.8), and CRP (Δ = 0.2; 95% CI = 0.03, 0.4). No serious adverse events occurred. CONCLUSIONS: A beneficial effect at week 24 was found on weight; fasting also induced various positive short-term effects in patients with MS. Fasting can thus be considered a treatment for initializing lifestyle modification for this patient group; however, it remains to be investigated whether and how the multilayered effects of fasting can be maintained in the medium and longer term.

Therapeutic Phlebotomy in Patients with Grade 1 Hypertension: A Randomized-Controlled Trial.

Aim: Study aim was to investigate the effects of therapeutic phlebotomy on ambulatory blood pressure in patients with grade 1 hypertension. Methods: In this randomized-controlled intervention study, patients with unmedicated hypertension grade 1 were randomized into an intervention group (phlebotomy group; 500 mL bloodletting at baseline and after 6 weeks) and a control group (waiting list) and followed up for 8 weeks. Primary endpoint was the 24-h ambulatory mean arterial pressure between the intervention and control groups after 8 weeks. Secondary outcome parameters included ambulatory/resting systolic/diastolic blood pressure, heart rate, and selected laboratory parameters (e.g., hemoglobin, hematocrit, erythrocytes, and ferritin). Resting systolic/diastolic blood pressure/heart rate and blood count were also assessed at 6 weeks before the second phlebotomy to ensure safety. A per-protocol analysis was performed. Results: Fifty-three hypertension participants (56.7 ± 10.5 years) were included in the analysis (n = 25 intervention group, n = 28 control group). The ambulatory measured mean arterial pressure decreased by -1.12 ± 5.16 mmHg in the intervention group and increased by 0.43 ± 3.82 mmHg in the control group (between-group difference: -1.55 ± 4.46, p = 0.22). Hemoglobin, hematocrit, erythrocytes, and ferritin showed more pronounced reductions in the intervention group in comparison with the control group, with significant between-group differences. Subgroup analysis showed trends regarding the effects on different groups classified by serum ferritin concentration, body mass index, age, and sex. Two adverse events (AEs) (anemia and dizziness) occurred in association with the phlebotomy, but no serious AEs. Conclusions: Study results showed that therapeutic phlebotomy resulted in only minimal reductions of 24-h ambulatory blood pressure measurement values in patients with unmedicated grade 1 hypertension. Further high-quality clinical studies are warranted, as this finding contradicts the results of other studies.

Mental and Behavioural Responses to Bahá'í Fasting: Looking behind the Scenes of a Religiously Motivated Intermittent Fast Using a Mixed Methods Approach.

BACKGROUND/OBJECTIVE: Historically, fasting has been practiced not only for medical but also for religious reasons. Bahá'ís follow an annual religious intermittent dry fast of 19 days. We inquired into motivation behind and subjective health impacts of Bahá'í fasting. METHODS: A convergent parallel mixed methods design was embedded in a clinical single arm observational study. Semi-structured individual interviews were conducted before (n = 7), during (n = 8), and after fasting (n = 8). Three months after the fasting period, two focus group interviews were conducted (n = 5/n = 3). A total of 146 Bahá'í volunteers answered an online survey at five time points before, during, and after fasting. RESULTS: Fasting was found to play a central role for the religiosity of interviewees, implying changes in daily structures, spending time alone, engaging in religious practices, and experiencing social belonging. Results show an increase in mindfulness and well-being, which were accompanied by behavioural changes and experiences of self-efficacy and inner freedom. Survey scores point to an increase in mindfulness and well-being during fasting, while stress, anxiety, and fatigue decreased. Mindfulness remained elevated even three months after the fast. CONCLUSION: Bahá'í fasting seems to enhance participants' mindfulness and well-being, lowering stress levels and reducing fatigue. Some of these effects lasted more than three months after fasting.

Effects of a Supplement Containing a Cranberry Extract on Recurrent Urinary Tract Infections and Intestinal Microbiota: A Prospective, Uncontrolled Exploratory Study.

Aim: Cranberries (Vaccinium macrocarpon) are traditionally used in prevention of urinary tract infections (UTIs). The authors' aim was to evaluate effects of a supplement containing cranberry extract, pumpkin seed extract, vitamin C, and vitamin B2 on recurrent uncomplicated UTIs in women and their intestinal microbiota. Methods: A prospective, uncontrolled exploratory study was conducted in women with recurrent uncomplicated UTIs. The primary exploratory outcome was the number of UTIs in a 6-month prospective observation period compared with a 6-month retrospective period. Further outcomes included number of antibiotics, quality of life (SF-36), intestinal microbiota (assessed by 16S rRNA amplicon sequencing), and evaluation questions. Parameters were assessed at baseline and after 1, 2, and 7 months (start of intake of cranberry supplement after 1 month for 6 months). p-Values were calculated with the pairwise Wilcoxon signed-rank test for α diversity and permutational multivariate analysis of variance. Results: Twenty-three women (aged 52.7 ± 12.4 years) were included in the study. Participants reported 2.2 ± 0.8 UTIs (at baseline) in the previous 6 months. After 6 months of cranberry intake, participants reported a significant decrease to 0.5 ± 0.9 UTIs (p < 0.001). Number of antibiotic therapies was also significantly (p < 0.001) reduced by 68% during 6 months of cranberry intake (0.14 ± 0.35) when compared with 6 months retrospectively (1.14 ± 0.71). The SF-36 physical component score increased from 44.9 ± 5.5 at baseline to 45.7 ± 4.6 at 7 months (p = 0.16). The SF-36 mental component score decreased slightly from the baseline value of 46.5 ± 6.5 to 46.2 ± 6.4 at 7 months (p = 0.74). No significant intragroup mean changes at genus, family, or species level for α and ß diversity within the intestinal microbiota were found. In the evaluation questions, participants rated the cranberry extract positively and considered it beneficial. The supplement intake was safe. Conclusions: This study shows that women with recurrent uncomplicated UTIs benefit from cranberry intake. Future larger clinical studies with further investigation of the mechanisms of action are required to determine the effects of cranberries on participants with uncomplicated UTIs.

Ayurvedic vs. Conventional Nutritional Therapy Including Low-FODMAP Diet for Patients With Irritable Bowel Syndrome-A Randomized Controlled Trial.

Aims: To compare the effects of Ayurvedic and conventional nutritional therapy in patients with irritable bowel syndrome (IBS). Methods: Sixty-nine patients with IBS were randomized to Ayurvedic (n = 35) or conventional nutritional therapy according to the recommendations of the German Nutrition Society including the low-FODMAP diet (n = 34). Study visits took place at baseline and after 1, 3, and 6 months. The primary outcome was IBS symptom severity (IBS-SSS) after 3 months; secondary outcomes included stress (CPSS), anxiety and depression (HADS), well-being (WHO-5) and IBS-specific quality of life (IBS-QOL). A repeated measures general linear model (GLM) for intent-to-treat-analyses was applied in this explorative study. Results: After 3 months, estimated marginal means for IBS-SSS reductions were 123.8 [95% confidence interval (95% CI) = 92.8-154.9; p < 0.001] in the Ayurvedic and 72.7 (95% CI = 38.8-106.7; p < 0.001) in the conventional group. The IBS-SSS reduction was significantly higher in the Ayurveda group compared to the conventional therapy group (estimated marginal mean = 51.1; 95% CI = 3.8-98.5; p = 0.035) and clinically meaningful. Sixty-eight percentage of the variance in IBS-SSS reduction after 3 months can be explained by treatment, 6.5% by patients' expectations for their therapies and 23.4% by IBS-SSS at pre-intervention. Both therapies are equivalent in their contribution to the outcome variance. The higher the IBS-SSS score at pre-intervention and the larger the patients' expectations, the greater the IBS-SSS reduction. There were no significant group differences in any secondary outcome measures. No serious adverse events occurred in either group. Conclusion: Patients with IBS seem to benefit significantly from Ayurvedic or conventional nutritional therapy. The results warrant further studies with longer-term follow-ups and larger sample sizes. Clinical Trial Registration:https://clinicaltrials.gov/ct2/show/NCT03019861, identifier: NCT03019861.

Efficacy of therapeutic fasting and plant-based diet in patients with rheumatoid arthritis (NutriFast): study protocol for a randomised controlled clinical trial.

BACKGROUND: Previous studies have shown beneficial effects of therapeutic fasting and plant-based dietary interventions on disease activity in patients with rheumatoid arthritis (RA) for a duration of up to 1 year. To date, the effects of such interventions on the gut microbiome and on modern diagnostic markers in patients with RA have not been studied. This trial aims to investigate the clinical effects of therapeutic fasting and a plant-based diet in patients with RA, additionally considering current immunological diagnostic tools and microbiome analyses. METHODS/DESIGN: This trial is an open-label, single-centre, randomised, controlled, parallel-group clinical trial. We will randomly assign 84 patients with RA under a stable standard therapy to either (1) therapeutic fasting followed by a plant-based dietary intervention or (2) to a conventional nutritional counselling focusing on an anti-inflammatory dietary pattern according to the recommendations of the Deutsche Gesellschaft für Ernährung (German society for nutrition). Primary outcome parameter is the group difference from baseline to 12 weeks on the Health Assessment Questionnaire (HAQ). Other secondary outcomes include established clinical criteria for disease activity and treatment response in RA (Disease Activity Score 28, Simple Disease Activity Index, ACR-Response Criteria), changes in self-reported health and physical functional ability, mood, stress, quality of life, dietary behaviour via 3-day food records and a modified Food Frequency Questionnaire, body composition, changes in the gut microbiome, metabolomics and cytometric parameters. Outcomes will be assessed at baseline and day 7, after 6 weeks, 12 weeks and after 6 months. ETHICS AND DISSEMINATION: Ethical approval to process and analyse data, and to publish the results was obtained through the institutional review board of Charité-Universitätsmedizin Berlin. Results of this trial will be disseminated through peer-reviewed publications and scientific presentations. TRIAL REGISTRATION NUMBER: NCT03856190.

Yoga, Eurythmy Therapy and Standard Physiotherapy (YES-Trial) for Patients With Chronic Non-specific Low Back Pain: A Three-Armed Randomized Controlled Trial.

We aimed to evaluate the effects of yoga and eurythmy therapy compared to conventional physiotherapy exercises in patients with chronic low back pain. In a three-armed, multicentre, randomized controlled trial, patients with chronic low back pain were treated for 8 weeks in group sessions (75 minutes once per week). Primary outcome was patients' physical disability (measured by RMDQ) from baseline to week 8. Secondary outcome variables were pain intensity and pain-related bothersomeness (VAS), health-related quality of life (SF-12) and life satisfaction (BMLSS). Outcomes were assessed at baseline, after the intervention at 8 weeks and at a 16-week follow up. Data of 274 participants were used for statistical analyses. There were no significant differences between the three groups for the primary and all secondary outcomes. In all groups, RMDQ decreased comparably at 8 weeks, but did not reach clinical meaningfulness. Pain intensity and pain-related bothersomeness decreased, while quality of life increased in all 3 groups. In explorative general linear models for the SF-12's mental health component participants in the eurythmy arm benefitted significantly more compared to physiotherapy and yoga. Furthermore, within-group analyses showed improvements of SF-12 mental score for yoga and eurythmy therapy only. All interventions were safe. Clinical Trials Register: DRKS-ID: DRKS00004651 Perspective: This article presents the results of a multicentre three-armed randomized controlled trial on the clinical effects of three 8-week programs in patients with chronic low back pain. Compared to the 'gold standard' of conventional physiotherapeutic exercises, eurythmy therapy and yoga therapy lead to comparable symptomatic improvements in patients with chronic low back pain. However, the within-group effect sizes were small to moderate and did not reach clinical meaningfulness on patients' physical disability (RMDQ).

More than just warmth-The perception of warmth and relaxation through warming compresses.

OBJECTIVES: To differentiate the effect of ginger and mustard as warming ingredients from the effect of calmness & attentiveness and thermal warmth in chest compress application. DESIGN & SETTING: In an exploratory, controlled, single-blinded study, we compared the effect of ginger and mustard in healthy adults. INTERVENTIONS: Participants received four different chest compress types over four weeks: simple dry, hot water, with ginger powder and with mustard flour. OUTCOME MEASURES: The somatic and psychological experience of the participants was collected through psychometric measurements (list of somatic complaints (B-L), questionnaire on mental state (MDBF), 5-point-rating scale (RS) containing eight questions on the experience of relaxation and warmth) and was further complemented through qualitative interview data. RESULTS: Participants (15 female and 15 male) ranged between 21-36 years (M = 27). No significant changes in the B-L could be found. The MDBF found significant change towards calmness after every application (P < 0.05). Significant improvement in mood was found after the ginger compress (P = 0.00). The RS found significant changes towards relaxation (P = 0.00), emotional balance (P = 0.03), deep (P = 0.03) and slow (P = 0.00) breathing as well as warm hands (P = 0.03) and feet (P = 0.00) with the ginger compress. No significant changes on the RS could be found after the mustard compress. Qualitative-phenomenological data underlined the difference between ginger and mustard in quality of warmth. No adverse effects were reported. CONCLUSIONS: Ginger and mustard induced a strong and lasting response on perceived distribution of warmth and relaxation. Compound effect quality could be differentiated: mustard triggered a strong relaxing effect after the intervention and ginger a warmth quality that spread throughout the body.

Yoga in school sports improves functioning of autonomic nervous system in young adults: A non-randomized controlled pilot study.

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.

Yoga in school sport - A non-randomized controlled pilot study in Germany.

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 ±â€¯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.

Ketogenic diet and fasting diet as Nutritional Approaches in Multiple Sclerosis (NAMS): protocol of a randomized controlled study.

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 diets (FDs) and ketogenic diets (KDs) are an alternative and presumably more efficient energy source for the brain. Studies on mice with experimental autoimmune encephalomyelitis showed beneficial effects of KDs and FDs 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 whether 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: a KD with a restricted carbohydrate intake of 20-40 g/day; a FD with a 7-day fast every 6 months and 14-h daily intermittent fasting in between; and 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 a KD and a 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 a FD on disease progression of MS. TRIAL REGISTRATION: ClinicalTrials.gov, NCT03508414. Retrospectively registered on 25 April 2018.

A nonrandomized controlled clinical pilot trial on 8 wk of intermittent fasting (24 h/wk).

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 < 0.05 was considered significant. 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.

The Effectiveness of Leech Therapy in Chronic Low Back Pain.

BACKGROUND: Leech therapy has been found to be effective in the treatment of a number of chronic musculoskeletal pain syndromes. Leeches are also often used empirically to treat chronic low back pain, but data from clinical trials have been lacking to date. We therefore conducted the first randomized trial of leech therapy for chronic low back pain. METHODS: Patients with chronic low back pain were randomized to receive either a single session of local treatment with 4-7 leeches or four weekly sessions of exercise therapy (1 hour each) led by a physical therapist. The primary endpoint was a change in average back pain intensity, as measured using a 100-mm visual analog scale (VAS), after 28 days. Secondary end- points included functional impairment (Roland-Morris Disability Questionnaire, Hannover Functional Ability Questionnaire), quality of life (Short-Form Health Questionnaire [SF 36]), pain perception (pain perception scale = Schmerzempfindungsskala [SES]), depressivity (Center for Epidemiological Studies Depression Scale [CES-D]), and analgesic consumption (questionnaire/ diary). Trial visits took place before treatment and on days 28 ± 3 and 56 ± 5 after the start of treatment; the overall duration of the trial was 56 ± 5 days. RESULTS: The mean low back pain score improved from 61.2 ± 15.6 before treatment to 33.1 ± 22.4 on day 28 in the leech ther- apy group (n = 25) and from 61.6 ± 14.8 to 59.8 ± 16.7 in the exercise therapy group (n = 19) (group difference -25.2; 95% con- fidence interval [-41.0; -9.45]; p = 0.0018). Significant benefits of leech therapy were also found at both time points with respect to physical impairment and function as well as physical quality of life. The patients' expectations from treatment were higher in the leech therapy group but did not significantly affect the findings. CONCLUSION: A single session of leech therapy is more effective over the short term in lowering the intensity of pain over the short term and in improving physical function and quality of life over the intermediate term (4 weeks and 8 weeks, respectively). The limitations of this trial are the lack of blinding and the small number of patients. Leech therapy appears to be an effective treat- ment for chronic low back pain.

Ayurvedic versus conventional dietary and lifestyle counseling for mothers with burnout-syndrome: A randomized controlled pilot study including a qualitative evaluation.

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.