Interdisciplinary Integrative Oncology Group-Based Program: Evaluation of Long-Term Effects on Resilience and Use of Complementary and Alternative Medicine in Patients With Cancer.

BACKGROUND: Cancer often causes reduced resilience, quality of life (QoL) and poorer overall well-being. To mitigate these problems, complementary and alternative medicine (CAM) is widely used among patients with cancer. This study aimed to evaluate the long-term effects of an interdisciplinary integrative oncology group-based program (IO-GP) on the resilience and use of CAM in patients with cancer. METHODS: This was a prospective, observational, single-center study. Resilience (RS-13), CAM usage (I-CAM-G), QoL (SF-12) and health-related lifestyle factor (nutrition, smoking, alcohol consumption and physical exercise) data were collected for 70 patients who participated in a 10-week IO-GP between January 2019 and June 2022 due to cancer. The IO-GP is offered at the setting of a university hospital and is open to adult patients with cancer. It contains elements from mind-body medicine and positive psychology, as well as recommendations on healthy diet, exercise and CAM approaches. Patients who completed the IO-GP at least 12 months prior (1-4.5 years ago) were included in this study. Statistical analysis included descriptive analysis and parametric and nonparametric tests to identify significant differences (P < .05). RESULTS: Resilience increased significantly ≥12 months after participation in the IO-GP (n = 44, P = .006, F = 8.274) and had a medium effect size (r = .410). The time since the IO-GP was completed ("12-24 months," "24-36 months," and ">36 months") showed no statistically significant interaction with changes in resilience (P = .226, F = 1.544). The most frequently used CAM modalities within the past 12 months were vitamins/minerals (85.7%), relaxation techniques (54.3%), herbs and plant medicine (41.1%), yoga (41.4%) and meditation (41.4%). The IO-GP was the most common source informing study participants about relaxation techniques (n = 24, 64.9%), meditation (n = 21, 72.4%) and taking vitamin D (n = 16, 40.0%). Significantly greater levels of resilience were found in those practicing meditation (P = .010, d = -.642) or visualization (P = .003, d = -.805) compared to non-practitioners. CONCLUSION: IO-GPs have the potential to empower patients with cancer to continue using CAM practices-especially from mind-body medicine-even 1 to 4.5 years after completing the program. Additionally, resilience levels increased. These findings provide notable insight into the long-term effects of integrative oncology interventions on resilience and the use of CAM, especially in patients with breast cancer.

Variability in COVID-19 symptom presentation during pregnancy and its impact on maternal and infant outcomes across the pandemic.

BACKGROUND: With the dominance of different SARS-CoV-2 variants, the severity of COVID-19 has evolved. We aimed to investigate the difference in symptom prevalence and the association between symptoms and adverse pregnancy outcomes during the dominance of Wild-type/Alpha, Delta, and Omicron. METHODS: COVID-19 related symptom prevalence, maternal and specific neonatal outcomes of 5431 pregnant women registered in this prospective study were compared considering the dominant virus variant. Logistic regression models analyzed the association between specific symptoms and intensive care unit (ICU) admission or preterm birth. RESULTS: Infection with the Delta variant led to an increase in the symptom burden compared to the Wild-type/Alpha variant and the highest risk for respiratory tract symptoms, feeling of sickness, headache, and dizziness/drowsiness. An infection with the Omicron variant was associated with the lowest risk of dyspnea and changes in smell/taste but the highest risk for nasal obstruction, expectoration, headaches, myalgia, and fatigue compared to the Wild-type/Alpha and Delta variant dominant periods. With the progression of the Wild-type/Alpha to the Delta variant neonatal outcomes worsened. Dyspnea and fever were strong predictors for maternal ICU admission and preterm birth independent of vaccination status or trimester of infection onset. CONCLUSION: The symptom burden increased during the Delta period and was associated with worse pregnancy outcomes than in the Wild-type/Alpha area. During the Omicron dominance there still was a high prevalence of less severe symptoms. Dyspnea and fever can predict a severe maternal illness.

Validation of the predictive value of BDNF -87 methylation for antidepressant treatment success in severely depressed patients-a randomized rater-blinded trial.

BACKGROUND: Brain-derived neurotrophic factor (BDNF) is essential for antidepressant treatment of major depressive disorder (MDD). Our repeated studies suggest that DNA methylation of a specific CpG site in the promoter region of exon IV of the BDNF gene (CpG -87) might be predictive of the efficacy of monoaminergic antidepressants such as selective serotonin reuptake inhibitors (SSRIs), serotonin-norepinephrine reuptake inhibitors (SNRIs), and others. This trial aims to evaluate whether knowing the biomarker is non-inferior to treatment-as-usual (TAU) regarding remission rates while exhibiting significantly fewer adverse events (AE). METHODS: The BDNF trial is a prospective, randomized, rater-blinded diagnostic study conducted at five university hospitals in Germany. The study's main hypothesis is that {1} knowing the methylation status of CpG -87 is non-inferior to not knowing it with respect to the remission rate while it significantly reduces the AE rate in patients experiencing at least one AE. The baseline assessment will occur upon hospitalization and a follow-up assessment on day 49 (± 3). A telephone follow-up will be conducted on day 70 (± 3). A total of 256 patients will be recruited, and methylation will be evaluated in all participants. They will be randomly assigned to either the marker or the TAU group. In the marker group, the methylation results will be shared with both the patient and their treating physician. In the TAU group, neither the patients nor their treating physicians will receive the marker status. The primary endpoints include the rate of patients achieving remission on day 49 (± 3), defined as a score of ≤ 10 on the Hamilton Depression Rating Scale (HDRS-24), and the occurrence of AE. ETHICS AND DISSEMINATION: The trial protocol has received approval from the Institutional Review Boards at the five participating universities. This trial holds significance in generating valuable data on a predictive biomarker for antidepressant treatment in patients with MDD. The findings will be shared with study participants, disseminated through professional society meetings, and published in peer-reviewed journals. TRIAL REGISTRATION: German Clinical Trial Register DRKS00032503. Registered on 17 August 2023.