Mind Your Heart-II: Protocol for a behavioral randomized controlled trial of mindfulness training to promote self-care in patients with comorbid heart failure and cognitive impairment.

BACKGROUND: Heart failure (HF) self-care is a robust predictor of prognosis in HF patients. Cognitive impairment is a common comorbidity in HF patients and constitutes a major challenge to HF self-care. Mindfulness training (MT) has been shown to improve cognitive function and interoception, two components essential to promoting effective HF self-care. OBJECTIVES: The aims of the Mind Your Heart-II (MYH-II) study are to investigate the effects of MT on HF self-care via changes in cognitive function and interoception in patients with comorbid HF and cognitive impairment, and to study the process by which MT can improve cognitive function via vagal control. We hypothesize that MT will improve cognitive function, interoception, and vagal control, resulting in enhanced HF self-care, compared to control participants. METHODS: MYH-II is a mechanistic parallel phase II behavioral randomized controlled trial. We will enroll 176 English or Spanish-speaking patients with comorbid chronic HF and mild cognitive impairment. Participants will be randomized to either: (1) 8-week phone-delivered MT + Enhanced Usual Care (EUC), or (2) EUC alone. Participants will complete baseline, end-of-treatment (3 months), and follow-up (9 months) assessments. The primary outcome is cognitive function (NIH Toolbox Fluid Cognition Composite Score). Additional key outcomes include: interoception (heartbeat tracking task, Multidimensional Assessment of Interoceptive Awareness), HF self-care (Self-Care of Heart Failure Index v7.2), and vagal control (high-frequency heart rate variability). IMPLICATIONS: If study hypotheses are confirmed, phone-based MT may be a key tool for improving HF self-care, and possibly clinical outcomes, in HF patients with comorbid cognitive impairment.

Novel cannabidiol aspartame combination treatment (JW-100) significantly reduces ISGA score in atopic dermatitis: Results from a randomized double-blinded placebo-controlled interventional study.

BACKGROUND: Atopic dermatitis (AD) is a common and chronic inflammatory skin disease that erupts periodically. Although the negative impact of the disorder on overall quality of life has been well established, new treatments for AD are still needed. Various studies have reported on cannabidiol's effectiveness in relieving pain and easing inflammation while not presenting major health risks. AIMS: In this communication, we aim to demonstrate the effectiveness of a novel cannabidiol (CBD) and aspartame formulation, JW-100, in relieving signs and symptoms of AD. PATIENTS/METHODS: We conducted a double-blinded placebo-controlled interventional study randomizing patients to one of three treatment groups: JW-100 (CBD plus aspartame), CBD only, or placebo topical formulations. The Investigator's Static Global Assessment (ISGA) score was used to document any changes in AD resulting from the applied interventions at 14 days. RESULTS: Fifty-seven patients completed the trial and were included in the final analysis. The ISGA score of the patients at baseline was 2.56, 2.24, and 2.24, for the JW-100, CBD, and placebo groups, respectively. After two weeks of treatment, the ISGA score reduced by 1.28, 0.81, and 0.71, for the JW-100, CBD, and placebo groups, respectively. The JW-100 cohorts demonstrated statistically significant ISGA score reduction (p = 0.042). 50% of patients in the JW-100 group achieved ISGA score of clear or almost clear (0 or 1) with at least a 2-grade improvement from baseline after treatment (p = 0.028). Only 20% and 15% of patients in the CBD only and placebo groups reported ISGA score of clear or almost clear (0 or 1). CONCLUSIONS: JW-100, a novel topical formulation containing CBD and aspartame, was demonstrated to produce statistically significant improvements in AD following 14 days of topical application.