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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.

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.

BackgroundPrevious 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/designThis 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 disseminationEthical 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 numberNCT03856190.

Background Against the background of widely inconsistent data from randomized controlled trials (RCT), the use of cannabis-based medicines (CBM) from the perspective of patients with chronic non-cancer pain (CNCP) was described. Methods Based on a purposive/convenient sampling, patients were recruited from the Pain Clinic of Hannover Medical School who had been using CBM prescribed by a doctor for at least 6 months. The patients discussed their experiences with CBM in semi-structured individual interviews. The interview transcripts were coded and analyzed using a modified grounded theory approach with the help of MAXQDA ® . In addition, the Treatment Satisfaction Questionnaire with Medication (TSQM) was used. Results Theoretical saturation was reached after 32 interviews. Open and selective coding revealed the overarching phenomenon of “subjective pain experience under CBM therapy”, with one of the main themes being the “effect of CBM”. This revealed the categories “effect on pain” and “psychological” and “somatic effect”. The most important concepts were “pain intensity”, “pain management”, “stress management”, “musculoskeletal system”, and “sleep quality.” Constructing a theoretical framework 4 groups of responses to CBM treatment were identified. The focus is either on (I) pain reduction , (II) pain coping , (III) reduced stress or (IV) multidimensional aspects . When this classification was applied to topic of quality of life (QOL), the greatest effectiveness and highest overall satisfaction were found in group (IV). Mixed methods showed a continuous increase in the perceived effectiveness of CBM on pain-centered complaints from group (I) to (IV). Conclusions In line with the biopsychosocial understanding of chronic pain, it appears that those CNCP patients who benefit most from CBM are those who show the most far-reaching effects on both a physical and psychological level. The pleiotropic effects of CBM may be responsible for this. Based on these results, interdisciplinary prospective research appears sensible and necessary to further and systematically investigate this clinically relevant topic. Trial registration This study was registered with the German Clinical Trials Register (DRKS00037434), after approval by the local ethics committee (No. 8391_B0-K_2019).

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.

Medical cannabinoids are controversial. Their use is comparatively rare, but it is rising. Since 2017, cannabinoids can be prescribed in Germany for a broader range of indications. Patient surveys on these drugs are hampered by the stigmatization of cannabinoids and their (still) low prevalence in medical contexts. Against this background, patients' willingness to provide information is limited. Moreover, it is logistically challenging to reach them with a survey. A thorough knowledge of currently ongoing therapies and their effects and side effects, however, is important for a more appropriate and effective use of cannabinoids in the future. This study is an exploratory data collection using a representative sample. The main goal is to provide a detailed picture of the current use of medical cannabinoids in Germany. It is intended to identify subgroups that may benefit particularly well or poorly. We are conducting a representative, anonymous, cross-sectional, one-time, web-based survey based on mixed methods in 3 German federal states. Health conditions under cannabinoid therapy and before are documented with validated, symptom-specific questionnaires. This allows an estimation of the effect sizes of these therapies. The selection of parameters and questionnaires was based on the results of independent qualitative interviews in advance. Representative samples of the hard-to-reach study population are obtained by cluster sampling via contracted physicians of the statutory health insurance companies. Recruitment was ongoing until the end of June 2022, with 256 enrolled participants. Validated questionnaires on pain, spasticity, anorexia or wasting, multiple sclerosis, nausea or vomiting, depression, and attention deficit hyperactivity disorder (ADHD) were selected. Symptom scores are being assessed for both current conditions under cannabinoid therapy and conditions prior to this therapy (in retrospect). Validated questionnaires are also used for treatment satisfaction and general quality of life. These are supplemented by existing diagnoses, a detailed medication history, any previous experiences with cannabis or illegal substances, experiences with the prescription process, and sociodemographic data. Based on the results of the previous qualitative interviews, questions were added regarding prior experience with relaxation methods and psychotherapy, personal opinions about cannabinoids, pre-existing or symptom-related psychological trauma, and different experiences with different cannabis-based therapies. The exploratory mixed methods approach of this project is expected to provide valid and relevant data as a basis for future clinical research. The study design may be representative for a large proportion of outpatients treated with cannabinoids in the German federal states studied. It may have less bias toward social desirability and may provide valuable information in addition to existing studies. Due to the observational and cross-sectional nature of this study, various limitations apply. Causal relations cannot be drawn. German Clinical Trials Register DRKS00023344; https://drks.de/search/en/trial/DRKS00023344. DERR1-10.2196/38814.

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. 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.  = 216 participants (48.1% female, aged 51.8 ± 14.0) completed the survey, most of which (72%,  = 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,  < 0.001); improved well-being (WHO-5: +7.8 ± 5.9,  < 0.001) and fewer problems in PROMIS subscales (all  < 0.001). Patients suffering primarily from pain (72%,  = 155) reported a reduction of daily pain (NRS: -3.2 ± 2.0,  < 0.001), while participants suffering mainly from spasticity (8%,  = 17) stated decreased muscle spasticity (MSSS: -1.5 ± 0.6,  < 0.001) and better physical mobility (-0.8 ± 0.8,  < 0.001). Data suggests clinically relevant effects for most scores. Participants' attitudes toward cannabinoids (on a 5-point scale) improved (+1.1 ± 1.1,  < 0.001). Most patients (  = 146, 69%) did not report major difficulties with the cannabinoid prescription process, while (  = 27; 19%) had their cannabinoid therapy changed due to side effects. 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.

Objectives To compare quantitative image quality parameters in abdominal dual-energy computed tomography angiography (DE-CTA) using an advanced image-based (Mono+) reconstruction algorithm for virtual monoenergetic imaging and standard DE-CTA. Methods Fifty-five patients (36 men; mean age, 64.2 ± 12.7 years) who underwent abdominal DE-CTA were retrospectively included. Mono + images were reconstructed at 40, 50, 60, 70, 80, 90 and 100 keV levels and as standard linearly blended M_0.6 images (60 % 100 kV, 40 % 140 kV). The contrast-to-noise ratio (CNR) and signal-to-noise ratio (SNR) of the common hepatic (CHA), splenic (SA), superior mesenteric (SMA) and left renal arteries (LRA) were objectively measured. Results Mono+ DE-CTA series showed a statistically superior CNR for 40, 50, 60, 70 and 80 keV ( P  < 0.031) compared to M_0.6 images for all investigated arteries except SMA at 80 keV ( P  = 0.08). CNR at 40 keV revealed a mean relative increase of 287.7 % compared to linearly blended images among all assessed arteries ( P  < 0.001). SNR of Mono+ images was consistently significantly higher at 40, 50, 60 and 70 keV compared to M_0.6 for CHA and SA ( P  < 0.009). Conclusions Compared to linearly blended images, Mono+ reconstructions at low keV levels of abdominal DE-CTA datasets significantly improve quantitative image quality. Key Points • Mono+ combines increased attenuation with reduced image noise compared to standard DE-CTA. • Mono+ shows superior contrast-to-noise ratios at low keV compared to linearly-blended images. • Contrast-to-noise ratio in monoenergetic DE-CTA peaks at 40 keV. • Mono+ reconstructions significantly improve quantitative image quality at low keV levels.

Osteoporosis is a systemic metabolic skeletal disease characterized by low bone mass and strength associated with fragility fractures. Oxidative stress, which results from elevated intracellular reactive oxygen species (ROS) and arises in the aging organism, is considered one of the critical factors contributing to osteoporosis. Mitochondrial (mt)ROS, as the superoxide anion (O2−) generated during mitochondrial respiration, are eliminated in the young organism by antioxidant defense mechanisms, including superoxide dismutase 2 (SOD2), the expression and activity of which are decreased in aging mesenchymal progenitor cells, accompanied by increased mtROS production. Using a mouse model of osteoblast lineage cells with Sod2 deficiency, we observed significant bone loss in trabecular and cortical bones accompanied by decreased osteoblast activity, increased adipocyte accumulation in the bone marrow and augmented osteoclast activity, suggestive of altered mesenchymal progenitor cell differentiation and osteoclastogenesis. Furthermore, osteoblast senescence was increased. To date, there are only a few studies suggesting a causal association between mtROS and cellular senescence in tissue in vivo. Targeting SOD2 to improve redox homeostasis could represent a potential therapeutic strategy for maintaining bone health during aging.

There is strong evidence for a genetically driven neuronal contribution in schizophrenia (SCZ). Although imaging and postmortem studies also provide evidence for white matter alterations with implications of the oligodendroglial lineage in SCZ, it is unclear whether these disturbances are a secondary consequence of neuronal deficits or also, at least in parts, genetically driven and cell-autonomous. Using human induced pluripotent stem cells (hiPSCs) in combination with gene set enrichment analysis, we investigated the cellular impact of SCZ genetics on the oligodendroglial lineage. We performed unsupervised clustering analysis of hiPSC-differentiated neural cells including oligodendrocytes (iOLs) and their precursor cells (iOPCs) with corresponding human postmortem cell types from single-cell RNA sequencing (scRNAseq) data and conducted a comparative gene set enrichment analysis. Subsequently, we stratified individuals based on white matter alteration using diffusion tensor imaging (DTI) within a translational cohort (N = 112) and then explored the cellular effects of SCZ risk with hiPSC modelling in a subset of SCZ patients (N = 8) with disturbed white matter integrity and unaffected healthy controls (N = 7). hiPSC-iOPCs/iOLs expression profiles strongly correlated with human postmortem OPCs/OLs based on scRNAseq, and their transcriptional signatures were highly enriched in the genetic associations of SCZ. The cellular assessment of patient-derived iOPCs/iOLs revealed morphological alterations, including significantly increased branch length and elevated junction number in mature iOLs from SCZ. Moreover, transcriptomic profiling revealed a dysregulation in oligodendroglial cell signaling and proliferation. In sum, hiPSC-modelling shows an impact of SCZ genetics on dedicated features of the oligodendroglial lineage.