Effects of an integrative multimodal inpatient program on fatigue and work ability in patients with Post-COVID Syndrome-a prospective observational study.

Post-COVID syndrome (PCS) is characterized by a variety of non-specific symptoms. One of the leading symptoms is fatigue. So far, there is no evidence-based causal therapy established and treatment of PCS is primarily symptom-oriented. The Clinic for Internal and Integrative Medicine in Bamberg, Germany, offers a comprehensive multimodal integrative inpatient therapy for PCS patients. Within a prospective uncontrolled observational study, the results of N = 79 patients were analysed. Post-COVID fatigue patients were hospitalized for up to 14 days. The treatment consists of individual modules depending on the patient's needs. It includes a wide range of integrative non-pharmacological treatment modalities. Outcomes were assessed before and after the inpatient treatment as well as 6 months after discharge from the hospital. Results show that fatigue of post-COVID patients in this study (M = 76.30, SD = 10.18, N = 64) was initially significantly higher than in the subsample "women aged 60-92 years" of the general German population (M = 51.5, Schwarz et al. [Schwarz et al. in Onkologie 26:140-144, 2003]; T(63) = 19.50, p < .001). Fatigue was significantly and clinically relevant reduced directly after discharge (MT1 = 76.21, SD = 11.38, N = 42; MT2 = 66.57, SD = 15.55, N = 42), F(1, 41) = 19.80, p < .001, partial eta squared = .326, as well as six months after discharge (MT3 = 65.31, SD = 17.20, N = 42), F(1, 41), p < .001, partial eta squared = .371. Additionally, self-reported ability to work (NRS, 0-10) improved significantly from admission (MT1 = 2.54, SD = 2.23, N = 39) to discharge (MT2 = 4.26, SD = 2.60, N = 39), F(1, 38) = 26.37, p < .001, partial eta squared = .410), as well as to six months later (MT3 = 4.41, SD = 3.23, N = 39), F(1, 38) = 15.00, p < .001, partial eta squared = .283. The study showed that patients suffering from chronic post-COVID syndrome for several months can achieve a significant improvement in their leading fatigue symptoms and a significant improvement in the subjective assessment of their ability to work through a comprehensive two-week multimodal integrative inpatient program.

[Phytotherapeutic recommendations in medical guidelines for the treatment of gastroenterological diseases - a systematic review]. / Phytotherapeutische Empfehlungen in medizinischen Leitlinien zur Behandlung gastroenterologischer Erkrankungen ­ ein systematischer Überblick.

Phytotherapeutics are gaining influence in the treatment of gastroenterological diseases. Their popularity and growing evidence of efficacy contribute to their integration into medical guidelines. A systematic screening identified recommended phytotherapeutic approaches. Based on current scientific data, some recommendations for the use of phytotherapeutic agents are given. For irritable bowel syndrome the use of peppermint oil is "strongly recommended", especially for pain and flatulence. Other phytotherapeutics such as STW-5, Tibetan Padma Lax or warm caraway oil pads have proven effective in alleviating symptoms. It is "recommended" to integrate them into the treatment concept. For chronic constipation, 30g of fiber per day is recommended. Best data exists for plantago psyllium with moderate evidence and chicory inulin. In case of ulcerative colitis, plantago psyllium as well as the combination of myrrh, chamomile flower extract, and coffee charcoal can be used as a complementary treatment in maintaining remission. There is also an "open recommendation" for curcumin for both, remission induction and maintenance. Some phytotherapeutic treatments (e.g., Artemisia absintium, Boswellia serata) show evidence of effectiveness for the treatment of Crohn's disease, but data are not yet sufficient for recommendations. Cannabis-based medicines can be considered for abdominal pain and clinically relevant appetite loss if standard therapy is ineffective or contraindicated, but they should not be used for acute inflammation in active Crohn's disease. Further recommendations for other gastroenterological diseases are discussed. The safety and tolerability of the phytotherapeutics were rated as predominantly "very good" to "acceptable". Some clear recommendations for the use of phytotherapeutics to treat gastroenterological diseases show their great potential. Due to their wide range of effects, phytotherapeutics can be used very well as a complement to conventional medicines in case of complex regulatory disorders. However, further methodologically well-conducted impact studies would be helpful in order to be able to make further recommendations.

How effective is drinking natural mineral water against heartburn from functional dyspepsia, gastroesophageal reflux disease or other causes? A systematic review of clinical intervention studies.

Background For centuries, spring and other natural waters have been recommended as external or internal remedies for numerous diseases. For studies that examined the effects of drinking mineral waters against heartburn, gastroesophageal reflux disease (GERD), or functional dyspepsia a systematic review is lacking. Objectives The main aim of this systematic review was to examine the effects of drinking natural mineral waters on heartburn from various causes by identifying all published intervention studies and critically appraising their methods as well as summarizing their results. Methods We systematically searched the largest medical literature database MEDLINE, further relevant web sources and gray literature for randomized and non-randomized trials, with or without control groups, up to September 2021 and no language restrictions. Further inclusion criteria were adult patients with heartburn, drinking cure with natural mineral water as intervention, compared to no or other interventions (care-as-usual, waiting list). We defined the reduction of heartburn symptoms and duration of disease episodes as primary and quality of life as secondary outcomes. Two reviewers independently carried out the study quality assessments (risk of bias) using the National Institutes of Health-Study Quality Assessment Tools. Results Nine trials comprising 393 patients from Italy, Russia, Ukraine, and Germany fulfilled all inclusion criteria. We identified three randomized controlled trials (all with poor methodological quality), plus six before-after (pre/post) intervention studies without a control group. The intervention groups of the three comparative trials seemed to show a stronger reduction of self-reported heartburn symptoms, and duration of heartburn episodes than the respective control groups, however they all had a poor methodological quality. Conclusion Based on the best available evidence of clinical studies, we cannot recommend or advise against drinking natural mineral waters as a treatment for heartburn. The potential benefits of natural mineral waters that were reported in some studies with a lower evidence level (e.g., lacking a control group) should be verified by good quality randomized clinical trials with adequate comparison groups and longer follow-up periods. .

Evaluation of a multimodal stress management and comprehensive lifestyle modification program on quality-of-life and gastrointestinal symptoms in patients with Crohn's Disease - A randomized controlled pilot trial with nine-month follow-up.

BACKGROUND: Stress and lifestyle factors impact the course of Crohn's Disease (CD). Our primary objective was to assess whether patients with CD benefit from a mind-body-medicine stress management and lifestyle modification (MBM) program. METHODS: This 9-month two-arm pilot trial was conducted in Bamberg, Germany (2020-2021). Patients (18-75 years) with mild to moderate activity of CD and stable medication were enrolled and randomly assigned to either a 10-week MBM program (intervention group, IG) or a single 90-minutes education session (waiting list control group, CG). Primary endpoints were quality of life (IBDQ) and disease activity (HBI). Secondary endpoints were emotional distress, core self-evaluation, and inflammatory biomarkers 3 and 9 months after baseline assessment. RESULTS: We analysed data from thirty-seven patients (IG: n=19, mean±SD age 49.6±13.1 years, 68% female; CG: 18, 46.8±11.4, 67% female). Immediately after the intervention, 79% (IG) and 44% (CG) experienced a clinically relevant improvement (IBDQ score ≥16 points). This was similar after 9 months (63% vs 44%). There was no difference in disease activity (3 months: p=.082, 95%CI -1.3-2.6; 9 months: p=.251, 95%CI -1.2-2.5). Secondary outcomes indicated improvements in emotional distress, core self-evaluation, erythrocyte sedimentation rate after three and in emotional distress, T-cell-profiling in the blood, and fecal lactoferrin and calprotectin group after 9 months in the intervention group. CONCLUSION: Our study suggested benefits of a multimodal stress management and lifestyle modification program for patients with CD. Larger trials are needed to determine if the program can supplement or at least partially replace pharmacological treatment approaches. CLINICALTRIALS: gov ID: NCT05182645.

Pre-treatment expectations and their influence on subjective symptom change in Crohn's disease.

BACKGROUND: Treatment expectations reportedly shape treatment outcomes, but have not been studied in the context of multimodal therapy in Crohn's disease (CD). Therefore, the current study investigated the role of treatment expectations for subjective symptom changes in CD patients who have undergone an integrative multimodal therapy program. METHODS: Validated questionnaires were completed at the start of the treatment program and post intervention. Pre-treatment expectations and experienced symptom change were assessed with the Generic Rating Scale for Previous Treatment Experiences, Treatment Expectations, and Treatment Effects (GEEE); stress levels were quantified with the Perceived Stress Scale (PSS-10) and disease specific quality of life was quantified with the disease-specific Inflammatory Bowel Disease Questionnaire (IBDQ). We performed multiple linear and Bayesian regression to determine how expectations related to symptom change. RESULTS: N = 71 CD patients (66.2% female) were included. Stronger expectations regarding symptom improvement (b = 0.422, t = 3.70, p < .001) were associated with higher experienced symptom improvement. Additionally, Bayesian analysis provided strong evidence for including improvement expectations as a predictor of improvement experience (BFinclusion = 13.78). CONCLUSIONS: In line with research in other disorders, we found that positive treatment expectations were associated with experienced symptom improvement. In contrast, we found no indication that an experience of symptom worsening was associated with positive or negative baseline treatment expectations. Induction of positive expectations might be a potential avenue for improving treatment outcomes in CD therapy.

Investigating the Influential Factors of Mild Water-Filtered Infrared-A Whole-Body Hyperthermia for Pain Relief in Fibromyalgia: A Mixed-Methods Approach Focusing on Predictors and Patient Perspectives.

Fibromyalgia syndrome (FMS) is a chronic condition characterized by chronic widespread pain, persistent fatigue, and disrupted sleep, significantly impacting well-being. Mild water-filtered infrared-A (wIRA) whole-body hyperthermia (WBH) is emerging as a promising pain management approach to FMS. Within the present randomized controlled trial (ClinicalTrials ID: NCT05135936), FMS patients underwent six sessions of mild wIRA-WBH over 3 weeks. Their pain levels were assessed at baseline and at week 12, while body core temperature and plateau phase duration were monitored during WBH. Qualitative interviews were conducted at week 12. Results from this mixed-methods study revealed that baseline pain intensity and plateau phase duration significantly predicted pain intensity at week 12. Thematic analysis of the interviews revealed diverse patient experiences with the treatment, with all patients reporting improvements in perceived pain and overall well-being. The onset and duration of pain relief varied among individuals. Overall, the findings suggest that the duration of the plateau phase may serve as an indicator for long-term pain reduction, although individual factors may influence treatment outcomes. Despite varying experiences, a prevailing trend of positive patient evaluations emerged. This study sheds light on the potential of wIRA-WBH as a therapeutic option for alleviating pain for and enhancing the well-being of FMS patients.

Modified-Release Phosphatidylcholine (LT-02) for Ulcerative Colitis: Two Double-Blind, Randomized, Placebo-Controlled Trials.

BACKGROUND & AIMS: The aim of this study was to evaluate the efficacy of LT-02, a novel modified-release phosphatidylcholine (PC) formulation, for induction and maintenance of remission in patients with mild to moderate ulcerative colitis (UC) and inadequate response to mesalamine. METHODS: LT-02 was evaluated in a multicenter double-blind, randomized, placebo-controlled study comprising a 12-week induction trial (PCG-2), followed by a 48-week maintenance trial (PCG-4). In PCG-2, patients were randomized 1:1:1 to treatment with 0.8 g LT-02 4 times daily (QID), 1.6 g LT-02 twice daily (BID), or placebo, respectively. All patients continued to take a standard dose of oral mesalamine (≥2.4 g/day). The primary end point in PCG-2 was deep remission. Patients achieving remission at week 12 were randomly assigned 2:1:1 to 1.6 g LT-02 BID, placebo, or 500 mg mesalamine (3 times daily), respectively, in PCG-4; the primary end point was remission at 48 weeks. RESULTS: PCG-2 was terminated early for futility after a prespecified interim analysis; 466 patients (of 762 planned) were randomized. There was no statistically significant difference in deep remission at week 12 (placebo, 13.5%; LT-02 BID, 14.2%; LT-02 QID, 9.7%). In PCG-4, 150 patients (of approximately 400 planned) were randomized. There was no statistically significant difference in remission rates at week 48 (LT-02 BID, 49.3%; mesalamine, 50.0%; placebo, 43.2%). LT-02 was safe. CONCLUSIONS: Despite prior evidence of beneficial effects of PC in phase 2 trials, our induction study with LT-02 in patients with mild to moderate UC was terminated prematurely for futility. Signals of efficacy in maintenance therapy require confirmation in an adequately powered maintenance trial. LT-02 was safe and well-tolerated. CLINICALTRIALS: gov: NCT02280629, NCT02142725.

Complementary Medicine in Acute Care Hospitals: Questionnaire Survey with Heads of Bavarian Hospitals.

INTRODUCTION: The demand for complementary medicine (CM) is well studied in the outpatient sector, but representative data on type and extent of inpatient care using CM are missing. Therefore, our aim was to examine the range of CM treatments offered and the types of indications for using CM in acute care hospitals in the German state of Bavaria. METHODS: We conducted a cross-sectional questionnaire survey by contacting the medical heads of all 388 Bavarian acute care hospitals between November 2020 and April 2021. The questionnaire included a wide range of CM to assessed availability of CM supply, most frequent indications, and medical specialities. Furthermore, we assessed basic information about the hospital and the participating medical staff. RESULTS: A total of 101 (26%) hospitals participated in the survey. At least one CM treatment was offered by 92% of the responding hospitals and 75% offered at least 5 therapy modalities (mean of 10 treatments, range: 0-25). These were most commonly massage therapies (68%), relaxation techniques (63%), phytotherapy (60%), mindfulness-based treatments (53%), art, diet, and exercise therapies (each 48%), aromatherapy (46%), acupuncture, and compresses/poultices (both 42%). The most reported medical conditions for CM treatments (in descending order) were chronic pain, mental disorders, degenerative affections, sleep disorders, fatigue syndrome, functional gastrointestinal disorders, and acute pain. CONCLUSION: According to the Bavarian acute care hospitals that participated in our postal survey, a considerable part offered CM. Further research should include personal interviews and more detailed assessments of indications and attitudes for the use of CM in acute care hospital settings.Die Nachfrage nach Komplementärmedizinischen Verfahren (CM) ist für den ambulanten Sektor gut untersucht, aber es fehlen Daten über Art und Umfang der komplementärmedizinischen Versorgung im stationären Bereich. Unser Ziel war es daher, das CM-Angebot und die medizinischen Indikationen in Akutkrankenhäusern im Bundesland Bayern zu untersuchen.Wir führten eine Querschnittsbefragung durch, bei der die klinischen Leitungen aller 388 bayerischen Akutkrankenhäuser zwischen November 2020 und April 2021 angeschrieben wurden. Der Fragebogen inkludierte ein breites Spektrum an CM-Verfahren und erfasste deren Verfügbarkeit, die häufigsten Indikationen und Anwendungsgebiete. Ergänzend wurden grundlegende Informationen des Krankenhauses und des medizinischen Personals erfragt.Insgesamt nahmen 101 (26%) Krankenhäuser an der Befragung teil. Die meisten Ausfüllenden hatten mindestens zwei Jahrzehnte klinische Berufserfahrung. Mindestens eine CM Behandlung wurde von 92% der teilnehmenden Krankenhäuser angeboten und 75% boten mindestens 5 Therapiemodalitäten an (Mittelwert: 10 Behandlungen; Spanne: 0­25). Dabei handelte es sich am häufigsten um Massagen (68%), Entspannungstechniken (63%), Phytotherapie (60%), achtsamkeitsbasierte Behandlungen (53%), Kunst-, Ernährungs-und Bewegungstherapie (jeweils 48%), Aromatherapie (46%), Akupunktur und Kompressen/Umschläge (jeweils 42%). Die häufigsten genannten Indikationen für CM-Behandlungen waren (in absteigender Reihenfolge) chronische Schmerzen, psychische Störungen, degenerative Erkrankungen, Schlafstörungen, Erschöpfungssyndrom, funktionelle Magen-Darm-Beschwerden und akute Schmerzen.Nach Angaben der bayerischen Akutkrankenhäuser, die an unserer postalischen Umfrage teilgenommen haben, bietet ein erheblicher Teil CM an. Weitere Untersuchungen sollten persönliche Interviews und detailliertere Bewertungen der Indikationen und Einstellungen für den Einsatz von CM in Akutkrankenhäusern umfassen.

Distinct Alterations in Central Pain Processing of Visceral and Somatic Pain in Quiescent Ulcerative Colitis Compared to Irritable Bowel Syndrome and Health.

BACKGROUND AND AIMS: Despite relevance to pain chronicity, disease burden, and treatment, mechanisms of pain perception for different types of acute pain remain incompletely understood in patients with inflammatory bowel disease [IBD]. Building on experimental research across pain modalities, we herein addressed behavioural and neural correlates of visceral versus somatic pain processing in women with quiescent ulcerative colitis [UC] compared to irritable bowel syndrome [IBS] as a patient control group and healthy women [HC]. METHODS: Thresholds for visceral and somatic pain were assessed with rectal distensions and cutaneous thermal pain, respectively. Using functional magnetic resonance imaging, neural and behavioural responses to individually calibrated and intensity-matched painful stimuli from both modalities were compared. RESULTS: Pain thresholds were comparable across groups, but visceral thresholds correlated with gastrointestinal symptom severity and chronic stress burden exclusively within UC. Upon experience of visceral and somatic pain, both control groups demonstrated enhanced visceral pain-induced neural activation and greater perceived pain intensity, whereas UC patients failed to differentiate between pain modalities at both behavioural and neural levels. CONCLUSIONS: When confronted with acute pain from multiple bodily sites, UC patients' responses are distinctly altered. Their failure to prioritise pain arising from the viscera may reflect a lack of adaptive behavioural flexibility, possibly resulting from long-lasting central effects of repeated intestinal inflammatory insults persisting during remission. The role of psychological factors, particularly chronic stress, in visceral sensitivity and disease-specific alterations in the response to acute pain call for dedicated mechanistic research as a basis for tailoring interventions for intestinal and extraintestinal pain symptoms in IBD.

[Integrative medicine, naturopathic and complementary medicine in the treatment of fibromyalgia syndrome : An overview against the background of clinical experiences from routine treatment]. / Integrative Medizin, Naturheilkunde und Komplementärmedizin in der Therapie des Fibromyalgiesyndroms : Eine Übersicht vor dem Hintergrund klinischer Erfahrungen aus dem Versorgungsalltag.

Fibromyalgia syndrome is classified as a functional somatic syndrome. There are typical but not clearly defined symptom clusters, such as chronic widespread pain, non-restorative sleep, and a tendency to physical and/or mental exhaustion. The core principle of treatment in the S3 guidelines is a multimodal treatment, especially for severe forms of the disease. Complementary, naturopathic and integrative forms of treatment have an established place in the guidelines. Strong treatment recommendations with a high consensus exist for endurance, weight and functional training. Meditative forms of movement, such as yoga or qigong should also be used. In addition to a lack of physical activity, obesity is also accepted as an associated lifestyle factor and addressed in nutritional therapy and regulation therapy. The central aim is the activation and rediscovery of self-efficacy. Heat applications, such as warm baths/showers, saunas, infrared cabins or exercise in warm thermal water are in accordance with the guidelines. A current field of research is whole-body hyperthermia with water-filtered infrared A radiation. Other self-help strategies are dry brushing according to Kneipp or massaging with rosemary oil, mallow oil or the Aconite pain oil. Taking into account the patients preference, phytotherapeutic agents can also be used as herbal pain treatment (ash bark/trembling poplar bark/goldenrod herb), for sleep disorders in the form of sleep-inducing wraps (lavender heart compress) and internally (valerian, lavender oil capsules, lemon balm). Acupuncture treatment (either ear or body acupuncture) are accepted as part of a multimodal concept. The Clinic for Integrative Medicine and Naturopathy at the Hospital in Bamberg offers the three different formats of inpatient, day clinic and outpatient service covered by the health insurance.

Mild Water-Filtered Infrared-A Whole-Body Hyperthermia Reduces Pain in Patients with Fibromyalgia Syndrome-A Randomized Sham-Controlled Trial.

The challenging treatment situation of patients with fibromyalgia syndrome (FMS) requires additional therapy options. The effects of water-filtered infrared-A whole-body hyperthermia (WBH) versus sham hyperthermia on pain intensity were investigated in an outpatient setting within a two-armed randomized sham-controlled trial. n = 41 participants aged between 18 and 70 years with a medically confirmed diagnosis of FMS were randomized to WBH (intervention; n = 21) or sham hyperthermia (control; n = 20). Six treatments with mild water-filtered infrared-A WBH over a period of three weeks with at least one day in between treatments were applied. On average, the maximum temperature was 38.7 °C for a duration of approximately 15 min. The control group received exactly the same treatment except that an insulating foil between the patient and the hyperthermia device blocked most of the radiation. Primary outcome was pain intensity measured by the Brief Pain Inventory at week 4. Secondary outcomes included blood cytokine levels and FMS-related core symptoms and quality of life. Pain intensity at week 4 was significantly different between the groups in favor of WBH (p = 0.015). A statistically significant pain reduction in favor of WBH was also found at week 30 (p = 0.002). Mild water-filtered infrared-A WBH effectively reduced pain intensity at the end of treatment and follow-up.

Systematic review with meta-analysis: Stress-management interventions for patients with irritable bowel syndrome.

Irritable bowel syndrome (IBS) is a common chronic gastrointestinal disorder of unknown pathological origin that is associated with psychological distress and reduced health-related quality of life (HRQoL). We investigated the effects of stress-management for adults with IBS on typical symptoms, HRQoL and mental health. With predefined criteria (patients: adults with IBS; intervention: stress-management; control: care as usual or waitlist; outcome: patient-relevant; study-type: controlled trials), we registered the study with PROSPERO (168030) and searched the main medical databases. Two researchers independently reviewed the publications and assessed the risk of bias using the Scottish Intercollegiate Guidelines Network checklist. We performed meta-analysis with homogeneous trials of acceptable quality. After screening 6656 publications, ten suitable randomized trials of acceptable (n = 5) or low methodological quality (n = 5) involving 587 patients were identified. Our meta-analysis showed no effect of stress-management on IBS severity 1-2 months after the intervention (Hedges' g = -0.23, 95%-CI = -0.84 to -0.38, I2  = 86.1%), and after 3-12 months (Hedges' g = -0.77, 95%-CI = -1.77 to -0.23, I2  = 93.3%). One trial found a short-term reduction of symptoms, and one trial found symptom relief in the long-term (at 6 months). One of two studies that examined HRQoL found an improvement (after 2 months). One of two studies that examined depression and anxiety found a reduction of these symptoms (after 3 weeks). Stress-management may be beneficial for patients with IBS regarding the short-term reduction of bowel and mental health symptoms, whereas long-term benefits are unclear. Good quality RCTs with more than 6 months follow-up are needed.

[How Common are Complementary Medicine Procedures in Bavarian Acute Care Hospitals? Results of A Bavarian-wide Website Screening]. / Wie verbreitet sind komplementärmedizinische Verfahren in bayerischen Krankenhäusern? Eine Vollerhebung für Bayern mittels Website-Screening.

BACKGROUND: In Germany, complementary medicine is used by up to 62% of patients, but type and extent of in-patient complementary care are not known. The objective of this study was, therefore, to conduct a survey on complementary medicine procedures in Bavarian acute care hospitals by screening the websites of all respective facilities in order to cover a broad range of complementary procedures. METHODS: In 2020, an independent and comprehensive website screening of all 389 Bavarian acute hospitals, including all departments, was conducted by two independent raters. Complementary medicine procedures offered were analysed in total as well as separately by specialty. RESULTS: Among all 389 Bavarian acute care hospitals, 82% offered at least one and 66% at least three different complementary procedures on their website. Relaxation techniques (52%), acupuncture (44%), massage (41%), movement-, art-, and music therapy (33%, 30%, and 28%), meditative movement therapies like yoga (30%), and aromatherapy (29%) were offered most frequently. Separated by specialty, complementary procedures were most common in psychiatry/psychosomatics (relaxation techniques 69%, movement and art therapy 60% each) at 87%, and in gynaecology/obstetrics (most common acupuncture 64%, homeopathy 60%, and aromatherapy 41%) at 72%. CONCLUSION: The vast majority of Bavarian acute care hospitals also seem to conduct complementary medicine procedures in therapy, especially for psychological indications and in obstetrics and gynaecology, according to the hospital websites. How often these procedures are used in inpatient or outpatient settings as well as evidence on effectiveness of the applied procedures should be investigated in further studies.

Mind-body-medicine and comprehensive lifestyle-modification in patients with Crohn's disease-Feasibility of a randomized controlled trial under pandemic circumstances.

Introduction: Mind-body medicine (MBM) focuses on stress reduction and lifestyle changes. The primary objective of this pilot trial was to test study feasibility of a complex integrative MBM program for patients with Crohn's disease (CD), especially in rural regions, and under pandemic conditions. Methods: Patients were stratified and randomized to the intervention group (IG) or the control group (CG). The intervention included a weekly 6-h session for 10 weeks. The CG (waiting list) received an initial 90-min workshop and started the intervention 9 months later. The primary outcome for study feasibility was recruitment and retention rates, as well as reasons for drop-out. The trial took place in Bamberg, Germany (September 2020 to December 2021). Results: Totally 700 members of the German Crohn's and Colitis Organization-DCCV-were contacted. A total of 15% (102/700; 95% CI 12-17%) expressed interest to participate. Following screening, 41% (95% CI 32-50) were randomized to IG (n = 22) and CG (n = 20). The patients were on average (±standard deviation) 48 ± 13 years old, 67% were female, and have been suffering from CD for 20 ± 12 years. Patients traveled 71.5 ± 48.7 km (range: 9-227 km) to the intervention with no differences between IG and CG. At the 6-month follow-up, 36/42 (86%, 95% CI 74-95%) participants completed final assessment and 19/22 (86%, 95% CI 70-100%) the intervention. The most important reasons for non-responding were work-related (12/60; 20%) and for or drop-out pandemic-related anxiety (3/6). No patient and staff member became infected with SARS-CoV-2 during the study. Conclusion: The feasibility of the MBM study was confirmed in terms of predefined recruitment and retention criteria, both despite difficult conditions (including the rural setting) and patients' fears associated with the pandemic. It was crucial to develop appropriate hygiene and safety concepts that enable chronically ill patients to participate in helpful group-based interventions even under pandemic conditions. Clinical trial registration: ClinicalTrials.gov, identifier: NCT05182645.

[Position paper on reporting of intestinal ultrasound findings in patients with inflammatory bowel disease]. / Positionspapier zur Befunderhebung von Darmultraschallbefunden bei chronisch entzündlichen Darmerkrankungen.

BACKGROUND: Intestinal ultrasound is increasingly used for primary diagnosis, detection of complications and monitoring of patients with Crohn's disease and ulcerative colitis. Standardization of reporting is relevant to ensure quality of the methodology and to improve communication between different specialties. The current manuscript describes the features required for optimized reporting of intestinal ultrasound findings in inflammatory bowel disease (IBD). METHODS: An expert consensus panel of gastroenterologists, radiologists, pathologists, paediatric gastroenterologists and surgeons conducted a systematic literature search. In a Delphi- process members of the Kompetenznetz Darmerkrankungen in collaboration with members of the German Society for Radiology (DRG) voted on relevant criteria for reporting of findings in intestinal ultrasound. Based on the voting results statements were agreed by expert consensus. RESULTS: Clinically relevant aspects of intestinal ultrasound (IUS) findings have been defined to optimize reporting and to standardize terminology. Minimal requirements for standardized reporting are suggested. The statements focus on description of disease activity as well as on complications of IBD. Attributes of intestinal inflammation are described and illustrated by exemplary images. CONCLUSION: The current manuscript provides practical recommendations on how to standardize documentation and reporting from intestinal ultrasound findings in patients with IBD.

Use of complementary and alternative medicine (CAM) in patients with inflammatory bowel disease (IBD): results from a German nationwide survey of 2019 compared to a previous survey of 2002.

INTRODUCTION: In 2002, 50% of patients with Inflammatory Bowel Disease (IBD) had used complementary and alternative medicine (CAM) in Germany. This survey aimed to examine changes from 2002 to 2019 and predictors of CAM use in 2019. MATERIALS AND METHODS: In 2019, a questionnaire was sent randomly to 1000 members of the German Crohn's Colitis Association, the same sampling strategy was chosen 2002. Items assessed included, demographic characteristics, IBD diagnosis and disease history, medication use, patients' symptoms/quality of life, anxiety/depression and use of complementary therapies. RESULTS: The 2019 sample only differed slightly in case of gender (55% women) and disease (43% Ulcerative Colitis) from the 2002 sample. In 2019, 54% (227/417) reported having ever used CAM and 75% (396/417) planned to use CAM for their IBD in the future, whereby there was an evidence of a decrease in exclusive CAM use from 2002 (28%; 96/344) to 2019 (16%, 37/277; BF<.01). In logistic regression analyses, ulcerative colitis compared to Crohn's Disease (OR 0.59, p=.005), side effects of standard therapy (OR 1.94, p=.012), the use of corticosteroids (OR 0.54, p=.038) or biologics (OR 1.90, p = .020) and lower quality of life (OR 0.96, p=.002) were associated with CAM use in 2019. CONCLUSIONS: Every other patient with IBD used CAM and has thus indicated a need for a safe and evidence-based combination of conventional and complementary approaches. This would further support the desired decrease in exclusive -alternative- CAM use.

Multimodal stress reduction and lifestyle modification program for patients with ulcerative colitis: a qualitative study.

BACKGROUND: Over 2 million people in Europe are affected by ulcerative colitis, which often severely impacts the quality of life of those concerned. Among other factors, lifestyle and psychosocial factors seem to play an important role in pathogenesis and course of the disease and can be addressed as a complement to pharmacotherapy in comprehensive lifestyle modification programs. METHODS: This qualitative study as part of a mixed methods approach was carried out in the framework of a randomized controlled trial that examined the effect of a comprehensive lifestyle-modification-program (10-week-day clinic program) on quality of life in patients with ulcerative colitis. Qualitative interviews were conducted with 20 out of 47 patients of the intervention group after the program. The aim was to deepen, supplement, and expand the quantitative results of the trial, i.e. to examine individual perceptions of the intervention, including subjective changes and the extent to which elements of the program were integrated into everyday life. Qualitative content analysis techniques utilizing the software MAXQDA were used. RESULTS: Patients with ulcerative colitis in our sample often experienced multiple negative effects on different levels (physical, psychological, and social) and impaired quality of life because of their disease. They reported generally positively about the program itself, and emphasized perceived positive changes regarding their psychological and physical well-being. The interviews indicated a good implementation of elements learned during the intervention in everyday life. CONCLUSIONS: Through participation in a comprehensive lifestyle modification program in the structure of a day clinic complementary to pharmacotherapy, patients with ulcerative colitis can reduce psychosocial stress and physical symptoms and thereby actively improve their well-being and general quality of life. This patient-centered, holistic approach was rated as useful in countering the complex disease manifestation as well as meeting the individual needs of the patients regarding their disease. TRIAL REGISTRATION: clinicaltrials.gov NCT02721823.