Efficacy and safety of a lipid-containing artificial tear compared with a non-lipid containing tear: a randomized clinical trial.

BACKGROUND: Dry eye disease (DED) is a prevalent condition affecting over 16 million patients in the USA. DED and the symptoms of ocular discomfort are debilitating and a significant burden on patients. If left untreated, DED can progress to cause severe pathology. Treatment is often initiated by patients without consulting a healthcare professional. This study investigated the safety and efficacy of a novel lipid-containing eye drop (BTC), which might better mimic the components of natural tears. METHODS: This was a multicenter, randomized, double-masked, active control, two arm, parallel group study of eye drops in adult subjects with self-reported DED. Subjects were randomly assigned to BTC or control (commercially available non-lipid eye drops; NLED) arm and were followed for 30 days. Assessments using visual analog scale and patient-reported outcomes (PRO) questionnaires, non-invasive tear break up time, slit-lamp examination, and subject-reported ocular symptoms were conducted at baseline and at days 7 and 30. The primary endpoint was change in overall ocular comfort score from baseline to day 30. RESULTS: 158 subjects were randomized, of whom 130 completed the study per protocol (PP). Mean (SD) age was 47.8 (14.14) years. The mean (95% CI) change in overall comfort scores at the 30-day follow-up in the PP population was 21.4 (15.1, 27.7) for the test drop and 10.0 (3.9, 16.1) for the comparator. The mean (95% CI) treatment difference was 11.3 (2.6, 20.1); this met the pre-defined requirements for non-inferiority. There was no significant difference in the proportion of eyes with reported ocular symptoms between the groups. At day 7, the OR (95% CI) was 0.967 (0.528, 1.770) and at day 30 was 1.160 (0.610, 2.203). There were no Grade 3 or higher corneal edema, corneal neovascularization, corneal staining, conjunctival injection, tarsal abnormalities or any other biomicroscopy findings, and no corneal infiltrates observed during the study. CONCLUSIONS: The investigational lipid eye drop BTC was noninferior to the commercially available non-lipid comparator in all parameters measured and has the potential to provide an effective therapy for subjects with symptoms of dry eye who would benefit from a lipid-based artificial tear. TRIAL REGISTRATION: NCT03995355 ( http://www. CLINICALTRIALS: gov ), registered June 24, 2019.

A novel multi-ingredient supplement significantly improves ocular symptom severity and tear production in patients with dry eye disease: results from a randomized, placebo-controlled clinical trial.

Introduction: Dry eye disease (DED) is multifactorial and characterized by a loss of tear film homeostasis that causes a cycle of tear film instability, tear hyperosmolarity, and inflammation. While artificial tears are the traditional mainstay of treatment, addressing the underlying pathophysiology could relieve symptoms and prevent progression. Increasing evidence indicates a role for oral nutritional supplementation in multiple ophthalmic diseases, including DED. Lutein, zeaxanthin, curcumin, and vitamin D3 have demonstrated protective and anti-inflammatory properties in ocular models. This prospective, randomized, double-blind, parallel, placebo-controlled study evaluated the efficacy and safety of a proprietary blend of lutein, zeaxanthin isomers, curcumin, and vitamin D3 (LCD) as a daily supplement in adult participants with DED. Methods: Participants were randomized to receive one LCD supplement capsule (lutein 20 mg, zeaxanthin isomers 4 mg, curcumin 200 mg curcuminoids, and vitamin D3 600 IU) or placebo per day for 8 weeks (LCD, n=77; placebo, n=78). Primary outcomes were changes in tear volume (Schirmer's test) and ocular symptoms (Ocular Surface Disease Index [OSDI]). Results: The study met its primary endpoints: the LCD group demonstrated significantly better Schirmer's test scores and improvement in overall OSDI score, versus placebo, at Day 56 (p<0.001 for both). Scores for total OSDI, and symptoms and vision domains, significantly improved by Day 14 for LCD versus placebo, (p<0.05 for all) and were maintained to Day 56 (p<0.001). In addition, the LCD group demonstrated significantly improved tear film break-up time (TBUT) and tear film osmolarity, versus placebo, by Day 56 (p<0.001), along with significant improvements in corneal and conjunctival staining (p<0.001 for both), and inflammation (matrix metalloproteinase-9; p<0.001 for each eye). Total Standard Patient Evaluation of Eye Dryness (SPEED) score, and scores for the frequency and severity domains, were significantly improved by Day 14 for LCD versus placebo (p<0.05 for all) and maintained to Day 56 (p<0.001). There was no difference between groups for artificial tear usage. The supplement was well-tolerated. Discussion: Once-daily LCD supplementation significantly improved tear production, stability and quality, reduced ocular surface damage and inflammation, and improved participants' symptoms. LCD supplementation could offer a useful adjunct to artificial tears for patients with DED (NCT05481450).

Physical activity and obesity in African Americans: the Jackson Heart Study.

OBJECTIVES: To better understand how obesity and low levels of physical activity (PA) contribute to racial health disparities, we examined the association of PA domains (work, home life, and leisure) with indicators of socioeconomic status and markers of obesity in African Americans. METHODS: These cross sectional analyses of interview and clinical measures from the baseline visit of the Jackson Heart Study of cardiovascular disease (CVD) in African Americans of the Jackson, Mississippi metropolitan statistical area included 3,174 women and 1,830 men aged 21-95 years. The main measures were active living, sport, work, home life, and total PA scores; participation in regular moderate or vigorous intensity leisure physical activity (MVLPA); demographics, body mass index (BMI), waist circumference (WC) and CVD risk factors. RESULTS: The sample was 63% female, 81% high school or college graduates, with 51% aged 45-64 years, and mostly overweight (32%) or obese (53%). Women were less active than men in all domains except home life. Total PA was inversely associated with WC in women and men. The overweight (BMI 25-29.9) group was most active in all domains except work; active living and sport PA and prevalence of MVLPA then declined in a dose response association with increasing BMI. Work PA was associated with the lowest BMI but otherwise with indicators of less favorable socioeconomic status and health. CONCLUSIONS: Observed differences in PA in African Americans by domain and association with obesity biomarkers suggest areas for future study and intervention to reduce health disparities.

Smoking behavior postmyocardial infarction among ENRICHD trial participants: cognitive behavior therapy intervention for depression and low perceived social support compared with care as usual.

INTRODUCTION: Patients with cardiovascular disease who stop smoking lower their risk of subsequent morbidity and mortality. However, patients who have suffered a myocardial infarction (MI) are more likely to be depressed than the general population, which may make smoking cessation more difficult. Poor social support may also make smoking cessation more difficult for some patients. This study examines the effect of cognitive behavior therapy (CBT) for depression, low perceived social support or both on smoking behavior in post-MI patients. METHODS: Participants were 1233 patients with a history of smoking enrolled in the Enhancing Recovery in Coronary Heart Disease Patients (ENRICHD) trial who provided 7-day point-prevalence smoking behavior information at baseline and at two or more follow-up assessments. The ENRICHD trial enrolled post-MI patients with depression, low perceived social support or both. Participants were randomly assigned to either CBT intervention or usual care. We used mixed effects models to accommodate data from multiple smoking point-prevalence measures for each individual participant. RESULTS: CBT did not significantly reduce post-MI smoking across all intervention patients with a history of smoking. However, CBT did reduce post-MI smoking among the subgroup of depressed patients with adequate perceived social support (OR, 0.68; 95% CI, 0.47-0.98). CONCLUSION: CBT for depression without more specific attention to smoking cessation may have little overall value as a strategy for helping post-MI patients refrain from smoking. However, use of CBT to treat depression may have the gratuitous benefit of reducing smoking among some post-MI patients.

Coping and quality of life in patients awaiting lung transplantation.

OBJECTIVE: Patients with end-stage lung disease (ESLD) experience significant decrements in quality of life (QOL). Although coping strategies are related to QOL in patients with ESLD, the extent to which specific native lung disease moderates this relationship is unknown. METHODS: We investigated the relationship between coping, native lung disease, and QOL among 187 patients awaiting lung transplantation, including 139 patients with chronic obstructive pulmonary disease (COPD) and 48 with cystic fibrosis (CF). Participants completed a psychosocial battery assessing psychological QOL, physical QOL, and coping strategies. RESULTS: For both COPD and CF patients, higher levels of Active Coping (P< .0001) and lower levels of Disengagement (P< .0001) were associated with better psychological QOL. For physical QOL, we observed a Native Disease x Coping interaction (P=.01) such that Active Coping was associated with better physical QOL in patients with COPD but not in patients with CF. CONCLUSIONS: The relationship between coping and QOL may vary as a function of native lung disease. Patients' native disease may need to be considered in order to develop effective interventions to help patients cope successfully with ESLD.

Exercise and pharmacotherapy in the treatment of major depressive disorder.

OBJECTIVE: To assess whether patients receiving aerobic exercise training performed either at home or in a supervised group setting achieve reductions in depression comparable to standard antidepressant medication (sertraline) and greater reductions in depression compared to placebo controls. METHODS: Between October 2000 and November 2005, we performed a prospective, randomized controlled trial (SMILE study) with allocation concealment and blinded outcome assessment in a tertiary care teaching hospital. A total of 202 adults (153 women; 49 men) diagnosed with major depression were assigned randomly to one of four conditions: supervised exercise in a group setting; home-based exercise; antidepressant medication (sertraline, 50-200 mg daily); or placebo pill for 16 weeks. Patients underwent the structured clinical interview for depression and completed the Hamilton Depression Rating Scale (HAM-D). RESULTS: After 4 months of treatment, 41% of the participants achieved remission, defined as no longer meeting the criteria for major depressive disorder (MDD) and a HAM-D score of <8. Patients receiving active treatments tended to have higher remission rates than the placebo controls: supervised exercise = 45%; home-based exercise = 40%; medication = 47%; placebo = 31% (p = .057). All treatment groups had lower HAM-D scores after treatment; scores for the active treatment groups were not significantly different from the placebo group (p = .23). CONCLUSIONS: The efficacy of exercise in patients seems generally comparable with patients receiving antidepressant medication and both tend to be better than the placebo in patients with MDD. Placebo response rates were high, suggesting that a considerable portion of the therapeutic response is determined by patient expectations, ongoing symptom monitoring, attention, and other nonspecific factors.

Effect of Flibanserin Treatment on Body Weight in Premenopausal and Postmenopausal Women with Hypoactive Sexual Desire Disorder: A Post Hoc Analysis.

BACKGROUND: Flibanserin, a 5-HT1A agonist and 5-HT2A antagonist, is indicated for the treatment of acquired, generalized hypoactive sexual desire disorder (HSDD) in premenopausal women. This post hoc analysis evaluated the effect of flibanserin treatment on body weight in premenopausal and postmenopausal women with HSDD. MATERIALS AND METHODS: This analysis included three 24-week, double-blind, placebo-controlled studies of flibanserin 100 mg each bedtime (qhs) in premenopausal women, a similarly designed study in postmenopausal women, and a 52-week, open-label extension study in premenopausal women. RESULTS: In a pooled analysis of premenopausal women, mean baseline body mass index (BMI) was 27.0 kg/m2 in the flibanserin group (n = 1227) and 26.8 kg/m2 in the placebo group (n = 1238). Among patients who completed 24 weeks of treatment, least squares (LS) mean weight change was -1.4 kg in the flibanserin group (n = 1010) and -0.1 kg in the placebo group (n = 1066; p < 0.0001). Weight loss ≥5% from baseline was reported in 21.0% of patients who received flibanserin and 7.8% of patients who received placebo; weight loss ≥10% was reported in 3.8% and 2.0% of patients, respectively. In postmenopausal women, mean baseline BMI was 27.7 kg/m2 in the flibanserin group (n = 467) and 27.3 kg/m2 in the placebo group (n = 480). LS mean weight change at week 24 was -1.8 kg in the flibanserin group (n = 385) and -0.1 kg in the placebo group (n = 425; p < 0.0001), with weight loss ≥5% reported in 24.7% and 7.3% of patients, respectively, and weight loss ≥10% reported in 5.2% and 1.7%, respectively. In HSDD patients with >12 months (n = 880) and >18 months (n = 637) of exposure to flibanserin, mean weight change was -1.0 and -1.2 kg, respectively; 25.4% and 26.9% of patients, respectively, experienced weight loss ≥5% from baseline, and 7.8% and 8.4%, respectively, experienced weight loss ≥10%. CONCLUSIONS: Women treated with flibanserin for HSDD may experience weight loss.

Psychosocial issues in the assessment and management of patients undergoing lung transplantation.

This review examines psychosocial issues among lung transplant patients from the time of assessment through the posttransplant period. Although psychological factors are recognized as being important in the transplant evaluation, no standard approach to psychological assessment currently exists. Lung transplant candidates often experience high levels of psychological distress while awaiting transplant, and both pretransplant and posttransplant psychological functioning have been found to predict posttransplant quality of life, adherence to treatment, and, in some cases, medical outcomes. Given the limited long-term survival following transplantation, improving psychosocial functioning is essential for enhancing outcomes among lung transplant recipients. This review summarizes the extant literature on the psychosocial factors in lung transplantation and highlights several innovative efforts to improve psychological outcomes in this challenging patient population.

Exercise training and depression in older adults.

This article provides a review of the evidence supporting exercise as an effective treatment of depression in older adults. Depression is prevalent among older adults and is associated with significant morbidity, increased risk of mortality, and economic burden. Although effective treatments for depression exist (e.g., antidepressant medication, cognitive-behavioral therapy), the disorder remains inadequately treated for many older individuals. Recently, the use of exercise as a treatment for depression has received increased attention. Results of these studies suggest that exercise leads to a reduction in depressive symptoms when compared to wait list, social contact controls, and antidepressant medication. However, many studies have significant methodological limitations. In the present article, we include discussion of these limitations and provide suggestions for future research.

Obesity, physical inactivity, and risk for cardiovascular disease.

Despite considerable progress in understanding disease mechanisms and risk factors, improved treatments, and public education efforts, cardiovascular disease (CVD) remains the leading cause of death in the United States. Obesity and physical inactivity, 2 important lifestyle-related risk factors for CVD, are prevalent in the southeastern United States and are becoming more prevalent in all racial groups and areas of the country. In reviewing these risk factors, we explored topics including prevalence and trends in population data; associated psychosocial and environmental factors; and some of the mechanisms through which these risk factors are thought to contribute to CVD. We identified significant, but as yet poorly understood, racial disparities in prevalence of obesity, low levels of physical activity, and correlates of these risk factors and examined important differences in the complex relationship between obesity, diabetes, and cardiovascular disease risk between African American and European American women. The Jackson Heart Study will provide important and unique information relevant to many unanswered questions about obesity, physical inactivity, and obesity in African Americans.

Adherence to exercise training in heart failure: a review.

Exercise training is increasingly recognized as a viable treatment option for patients with heart failure (HF). For exercise to be a maximally effective treatment, it is important that patients adhere to the exercise prescription. In this review, the current state of adherence monitoring and intervention in randomized HF trials will be summarized, along with recommendations for advancing understanding of adherence in this population. Barriers to exercise participation and strategies to enhance adherence to exercise-training programs will be explored. Finally, directions for future research on exercise adherence in HF patients will be provided.

Exercise as a treatment for depression and other psychiatric disorders: a review.

This article reviews evidence supporting exercise as a treatment for psychiatric disorders. Although data from randomized trials are limited, results of studies included in this review generally support use of exercise as an alternative or adjunctive treatment. Discussion of practical issues regarding exercise, potential mechanisms for the beneficial effects of exercise, and recommendations for future research are provided.