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 9-Month Follow-Up.

INTRODUCTION: 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-min 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 analyzed data from 37 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 = 0.082, 95% CI -1.3 to 2.6; 9 months: p = 0.251, 95% CI -1.2 to 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 IG. 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.

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.

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.