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.

Use and acceptance of traditional, complementary and integrative medicine in Germany-an online representative cross-sectional study.

Background: Older representative surveys show that Traditional, Complementary and Integrative Medicine (TCIM) is used by about 60% of the German population. However, no data exists for the current nationwide situation. The main aim of this cross-sectional study is to investigate the current use and acceptance of TCIM in Germany. Methods: This study is based on a representative sample of the German population aged 18-75 years. Participants were asked about the use and acceptance of TCIM. The survey was conducted online using Computer Assisted Web Interview (CAWI) in 2022 by three renowned German market research institutes on behalf of and in close coordination with the working group. The data set was analyzed descriptively and inferentially. Results: In total, 4,065 participants (52% female, 48% male, 0.4% diverse) responded completely (response rate: 21.5%). Among participants, 70% stated that they had used TCIM at some point in their lives, with 32% doing so in the last 12 months and 18% currently. The most common reason given (17%) was musculoskeletal pain. For their own health, 39% stated that TCIM is important. Traditional European Medicine was rated as very/mainly effective by 27% of participants and as partly effective by 44% (conventional medicine: 69% very/mainly effective, 19% partly effective). As a complementary treatment strategy to conventional medicine, 35% considered TCIM to be optimal ("Complementary Medicine"), 33% in combination with conventional medicine ("Integrative Medicine") and 5% without conventional medicine ("Alternative Medicine"). The majority of the participants were in favor of more research on TCIM and stated that the costs of TCIM services should be covered by health insurance companies (71% and 69%, respectively). Conclusion: These results from a representative online-population suggest that the use of TCIM in Germany remains at a high level. The nationwide relevance of TCIM should be given greater consideration in German health care policy making. TCIM should be systematically investigated using appropriate study designs and methods including high quality randomized clinical trials to investigate their effectiveness, efficacy, therapeutic safety and costs in the future.

Patients' perspectives on prescription cannabinoid therapies: a cross-sectional, exploratory, anonymous, one-time web-based survey among German patients.

Introduction: Since cannabinoids were partially legalized as prescription medicines in Germany in 2017, they are mostly used when conventional therapies do not suffice. Ambiguities remain regarding use, benefits and risks. This web-based survey explored the perspectives of patients whose experiences are not well enough known to date. Methods: In an anonymous, exploratory, cross-sectional, one-time web-based observational study, participants receiving cannabinoid therapy on prescription documented aspects of their medical history, diagnoses, attitudes toward cannabinoids, physical symptoms, and emotional states. Participants completed the questionnaires twice here: first regarding the time of the survey and then, retrospectively, for the time before their cannabinoid therapy. Participants were recruited in a stratified manner in three German federal states. Results: N = 216 participants (48.1% female, aged 51.8 ± 14.0) completed the survey, most of which (72%, n = 155) reported pain as their main reason for cannabinoid therapy. When comparing the current state with the retrospectively assessed state, participants reported greater satisfaction with their overall medical therapy (TSQM II: +47.9 ± 36.5, p < 0.001); improved well-being (WHO-5: +7.8 ± 5.9, p < 0.001) and fewer problems in PROMIS subscales (all p < 0.001). Patients suffering primarily from pain (72%, n = 155) reported a reduction of daily pain (NRS: -3.2 ± 2.0, p < 0.001), while participants suffering mainly from spasticity (8%, n = 17) stated decreased muscle spasticity (MSSS: -1.5 ± 0.6, p < 0.001) and better physical mobility (-0.8 ± 0.8, p < 0.001). Data suggests clinically relevant effects for most scores. Participants' attitudes toward cannabinoids (on a 5-point scale) improved (+1.1 ± 1.1, p < 0.001). Most patients (n = 146, 69%) did not report major difficulties with the cannabinoid prescription process, while (n = 27; 19%) had their cannabinoid therapy changed due to side effects. Discussion: Most participants experienced their therapy with cannabinoids as more effective than their previous therapy. There are extensive limitations to this cross-sectional study: the originally intended representativeness of the dataset was not reached, partly due to the SARS-CoV-2 pandemic; the sample has a larger proportion of privately insured and self-paying patients. Results does not suggest that cannabinoid patients belong to a particular clientele. Effect sizes observed for pain reduction, quality of life, social participation, and other outcomes suggest a therapeutic potential, particularly in the treatment of chronic pain.

Effects of an Online Meditation Course on Quality of Life and Positive Emotions: A Prospective Observational Study (EXPANSION Study).

Background: Several meditation interventions showed positive effects on physical and mental health. The aim of this study is a first evaluation of the (within-group) effects of a 21-day online meditation course of the "expansion method." Methods: For this exploratory observational study, parameters were assessed at baseline, at 1 month, and at a 3-month follow-up. Exploratory endpoints were health-related quality of life (PROMIS Preference Score), global health (PROMIS) with the subscales physical and mental health, stress perception (Perceived Stress Scale), positive and negative affect regulation (Positive and Negative Affect Schedule), flourishing (Flourishing Scale), self-efficacy (Short Scale for Measuring General Self-Efficacy Beliefs), gratitude and awe (Gratitude and Awe Questionnaire), resilience (Connor-Davidson Resilience Scale), spirituality (Aspects of Spirituality), and mysticism (Mysticism Scale) on validated inventories. In addition, self-constructed questions (NRS) assessed health status, lifestyle, and concept evaluation. Results: Data from 359 participants were included in this study (response rate: 68% at 1 month, 46% at 3 months). The main analysis was based on the complete cases at 1 month (n = 244 participants; 84% female; 51 ± 11 years; 89% German). Medium effect sizes were found for mental health (p < 0.0001; d = 0.6), flourishing (p < 0.0001; d = 0.63), and negative affect (p < 0.0001; d = 0.68) at 1 month. Small effect sizes were obtained for physical health, stress, positive affect, self-efficacy, spirituality, and mysticism at 3 months. In a sensitivity analysis, the strongest effects at 1 month were found in the subgroup that completed per-protocol (n = 140), followed by those with complete data at all time points (n = 159). Effects were lowest in the intention-to-treat analysis (n = 359). The content of the course was positively evaluated by the participants. Conclusions: The online meditation course based on the expansion method had potentially beneficial effects, especially on mental health parameters. Based on the feasibility results, further research using randomized controlled designs is warranted. Clinical Trial Registration: NCT04950543.

Effects of an Integrative Day Care Clinic Program with a Focus on Nature Therapy in a Hospital Park Setting on Quality of Life in Oncological Patients-A Non-Randomized Controlled Study.

Cancer often causes long-term physical and psychological impairments. Lifestyle modification and nature-based interventions (NBIs) can have a positive impact on patients' quality of life (QOL). This participants-blinded, non-randomized controlled study assessed parameters at weeks 0, 12, and 24, including, as a primary endpoint, QOL in cancer patients on the Functional Assessment of Cancer Therapy-General (FACT-G) at week 12. QOL in breast cancer patients, fatigue, well-being, stress, anxiety/depression, socio-psychological well-being, benefits of nature interaction, insomnia, self-efficacy, mindfulness, and self-compassion were assessed as secondary endpoints. N = 107 cancer patients (96.3% women; 52.5 ± 9.3 years, 80.4% breast cancer) were assigned to either a 12-week nature-based (NDC; n = 56) or conventional (DC; n = 51) oncology day care clinic program, whereby the assignment group was not known to the participants. There was no significant group difference for the primary endpoint. At week 24, QOL, fatigue, mindfulness and self-compassion scores were significantly higher, and at weeks 12 and 24, the insomnia score was significantly lower in NDC compared to DC. In conclusion, this study indicates positive and clinically relevant effects of the program on QOL, fatigue, and psychological parameters. NBIs seem to have a more pronounced effect.

Are Protective Activities and Limitations in Practical Skills of Daily Living Associated with the Cognitive Performance of People with Mild Cognitive Impairment? Baseline Results from the BrainFit-Nutrition Study.

Limitations in daily living have not yet been described adequately for mild cognitive impairment (MCI). In this study, we investigated first, time spent on protective activities (social, mental, and physical) and second, limitations in practical skills of daily living, both for people with MCI. We used baseline data from 270 individuals who participated in the randomized controlled trial BrainFit-Nutrition. The Montreal Cognitive Assessment (MoCA) was used to identify people with MCI. Participants were asked how much time they spent engaged in social, mental, and physical activities each week. Furthermore, the Bayer-ADL scale was used to quantify deficits in activities of daily living (ADLs). Regarding protection, the number of hours spent engaged in the three activity areas was significantly correlated with the cognitive performance in people with MCI. Social activities were positively associated with current cognitive performance. Concerning the limitations in practical skills of daily living, older and more cognitively impaired individuals were affected. Memory and orientation appear to be among the first practical skills of daily living that become impaired in people with MCI. Treatment recommendations for people with MCI include an increase in social, mental, and physical activities as well as the promotion of a healthy lifestyle.

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.

A Case Report of Acute Hepatitis Involving the Medicinal Herb Tinospora cordifolia Along with Other Variables.

This is a 54-year-old woman from Germany of central European origin who developed an acute hepatitis while orally taking Ayurvedic herbal remedies, among those was the medicinal herb Tinospora cordifolia. She took the plant powders from July 1, 2021, to October 1, 2021, with the intention of relieving the symptoms of her subjectively irritated gastrointestinal tract. The patient's main symptoms of acute hepatitis were progressively increasing general fatigue, nausea, and exhaustion. During an inpatient hospital admission from November 4, 2021, to November 9, 2021, she was under clinical observation, but no specific therapeutic measures were deemed necessary; however, blood chemistry showed an acute toxic hepatitis. There was no clinical or laboratory evidence of acute liver failure. Aminotransferase values decreased to normal values on December 14, 2021, by themselves. This case report contributes to the ongoing discussion about the potential risks of triggering an acute hepatitis due to the intake of herbal remedies from the Tinospora genus in rare cases, differentiating other involved risk factors. The case also shows that causality assignments are not trivial in the context of multivariate clinical scenarios. In the case of known hepatic metabolism-associated risk factors, T. cordifolia should be used with more caution based on available case reports. At the same time, no hasty and exaggerated prejudgments should be made about this medicinal herb, which has been very successfully used in traditional South Asian systems of medicine for many centuries.

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.

Ayurveda in Knee Osteoarthritis-Secondary Analyses of a Randomized Controlled Trial.

Background: Ayurveda is widely practiced in South Asia in the treatment of osteoarthritis (OA). The aim of these secondary data analyses were to identify the most relevant variables for treatment response and group differences between Ayurvedic therapy compared to conventional therapy in knee OA patients. Methods: A total of 151 patients (Ayurveda n = 77, conventional care n = 74) were analyzed according to the intention-to-treat principle in a randomized controlled trial. Different statistical approaches including generalized linear models, a radial basis function (RBF) network, exhausted CHAID, classification and regression trees (CART), and C5.0 with adaptive boosting were applied. Results: The RBF network implicated that the therapy arm and the baseline values of the WOMAC Index subscales might be the most important variables for the significant between-group differences of the WOMAC Index from baseline to 12 weeks in favor of Ayurveda. The intake of nutritional supplements in the Ayurveda group did not seem to be a significant factor in changes in the WOMAC Index. Ayurveda patients with functional limitations > 60 points and pain > 25 points at baseline showed the greatest improvements in the WOMAC Index from baseline to 12 weeks (mean value 107.8 ± 27.4). A C5.0 model with nine predictors had a predictive accuracy of 89.4% for a change in the WOMAC Index after 12 weeks > 10. With adaptive boosting, the accuracy rose to 98%. Conclusions: These secondary analyses suggested that therapeutic effects cannot be explained by the therapies themselves alone, although they were the most important factors in the applied models.

Meditation-based lifestyle modification in mild to moderate depression-A randomized controlled trial.

OBJECTIVE: Depression is a global key challenge in mental health care. The implementation of effective, low-risk and cost-effective interventions to reduce its disease burden is a necessity. The aim of this study was to investigate the efficacy of the new Meditation-Based Lifestyle Modification (MBLM) program, a "second-generation" mindfulness-based intervention, in depressive outpatients. METHODS: Eighty-one patients with mild to moderate depression were randomized into three groups: intervention group (MBLM), control group (CONTROL), and treatment as usual group (TAU). The primary outcome was the change of depressive symptoms as administered by the Beck Depression Inventory-II (BDI-II) after 4 and 8 weeks. Secondary outcome variables included the Brief Symptom Checklist-18 and the Perceived Stress Scale-10. A 6-month follow-up was conducted. RESULTS: A greater reduction of depressive symptoms was found in MBLM participants compared to CONTROL (p < .001, ηp2 = 0.11, d = 0.70) and TAU ( p<.001,ηp2=0.10,d=0.67$p\lt .001,{\eta }_{{\rm{p}}}^{2}=0.10,d=0.67$ ) with a 13.15 points reduction of BDI-II score versus 1.71 points (CONTROL) and 3.34 points (TAU) after 8 weeks. Between-group post hoc tests for all secondary outcomes and at follow-up also yielded significant between-group differences with medium to large effect sizes in favor of MBLM. CONCLUSIONS: Study results showed beneficial effects of MBLM in depressed outpatients. Further high-quality controlled clinical studies including qualitative research are needed to investigate the specific and unspecific effects of the MBLM program in depression and other medical conditions.

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.

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.

Self-care and lifestyle interventions of complementary and integrative medicine during the COVID-19 pandemic-A cross-sectional study.

Background: Complementary and Integrative Medicine (CIM), including self-care healthy life-style promotion strategies, is widely used in Germany. Aim of this study was to assess the use of self-care and lifestyle interventions as well as mental/emotional state experienced during the COVID-19 pandemic. Methods: An exploratory cross-sectional online study was conducted with adults in Germany through an online survey. Custom-developed questions in respiratory disease-status (including COVID-19), CIM-based self-care/lifestyle interventions and dietary patterns, and mental/emotional state as well as parameters for wellbeing (World Health Organization Well-Being Index, WHO-5) and self-efficacy (General Self-Efficacy Short Scale, GSE-3) were assessed. Data was analyzed using frequency and parametric measures. Results: The online survey was performed from January to March 2021 and included 1,138 participants (81.5% female; mean age: 49.2 ± 13.7 years; 54.9% holding a university degree) living in Germany, of which 62 had had a positive SARS-CoV-2 test, 4 an influenza infection and 375 participants other respiratory infections. The following individual health promotion strategies were reported: spending time in nature (90%; n = 1,024), physical activity (69.3%; n = 789), naturopathic remedies (63.1%; n = 718), plant-based diet (56.3%; n = 640), and Mind-Body interventions (54.7%; n = 623). No differences in strategies between individuals with respiratory diseases or the sample overall were found. Well-being had a mean value of 15.2 ± 5 (WHO-5) and self-efficacy 4.1 ± 0.6 (GSE-3). Nearly 8% reported a low mental/emotional state regarding the COVID-19 pandemic. Conclusion: Self-care and lifestyle interventions during the COVID-19 pandemic were reported by participants who were predominantly female, middle-aged, and well-educated. Most participants showed an overall balanced mental/emotional state. Further studies should include a representative control group from the general population. Clinical trial registration: clinicaltrials.gov, identifier NCT04653727.

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.

Effects of yoga and mindfulness practices on the autonomous nervous system in primary school children: A non-randomised controlled study.

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.