Evaluation of the Integrated Intervention for Dual Problems and Early Action Among Latino Immigrants With Co-occurring Mental Health and Substance Misuse Symptoms: A Randomized Clinical Trial.

Importance: Immigrants are at an increased risk for co-occurring mental health and substance misuse symptoms; however, effective treatments are lacking. Objective: To evaluate the effectiveness of the Integrated Intervention for Dual Problems and Early Action (IIDEA) program compared with enhanced usual care. Design, Setting, and Participants: This effectiveness randomized clinical trial was conducted from September 2, 2014, to February 2, 2017, in 17 clinics or emergency departments and 24 community sites in Boston, Massachusetts, as well as in Madrid and Barcelona, Spain. Equal randomization (1:1) in 2-person blocks was used, assigning participants to either the IIDEA treatment group (n = 172) or the enhanced usual care control group (n = 169). Intent-to-treat analyses assessed effectiveness, and post hoc analyses examined whether results varied by symptom severity or treatment dose. Eligible participants were between 18 and 70 years of age, self-identified as Latino, screened positive for co-occurring symptoms, and were not receiving specialty behavioral health services. Interventions: Participants were randomized to a 10-session IIDEA treatment or to enhanced usual care. Main Outcomes and Measures: Primary outcomes were changes in alcohol and drug misuse and results of a urine test for drug metabolites but not for alcohol misuse. Secondary outcomes were symptoms of depression, generalized anxiety, posttraumatic stress disorder, and overall mental health. Results: In total, 341 participants were randomized to either the IIDEA treatment group (n = 172; 94 [54.7%] female, mean [SD] age, 33.5 [11.6] years) or the enhanced usual care control group (n = 169; 80 [47.3%] female, mean [SD] age, 34.3 [11.8] years). No statistically significant effects of IIDEA were found for primary drug and alcohol outcomes (ASI Lite-drug score: ß = -0.02 [SE, 0.69; P = .88; Cohen d, 0.00; 95% CI, -0.17 to 0.17]; ASI Lite-alcohol score: ß = -0.01 [SE, 1.19; P = .66; Cohen d, 0.00; 95% CI, -0.12 to 0.12]; urine drug test result: ß = -0.36 [SE, 0.43; P = .50; OR, 0.70; 95% CI, 0.30-1.61]), but statistically significant effects were observed for secondary mental health outcomes. The IIDEA treatment was effective in reducing depressive symptoms per the Public Health Questionnaire-9 score (ß = -1.14; SE, 0.47; P = .02; Cohen d, 0.20 [95% CI, 0.04-0.36]), posttraumatic stress disorder symptoms per the Posttraumatic Stress Disorder Checklist-5 score (ß = -3.23; SE, 1.59; P = .04; Cohen d, 0.25 [95% CI, 0.01-0.37]), and overall mental health symptoms per the Hopkins Symptom Checklist-20 (ß = -0.20; SE, 0.07; P = .01; Cohen d, 0.25 [95% CI, 0.08-0.42]) and composite mental health (ß = -3.70; SE, 1.75; P = .04; Cohen d, 0.19 [95% CI, 0.01-0.36]) scores at the 6-month follow-up. Exploratory analyses suggested that 6-month treatment effects occurred for patients whose drug misuse was moderate to severe at the baseline assessment. Among patients with moderate to severe substance misuse, IIDEA substantially reduced substance use per the urine test results (odds ratio, 0.25 [95% CI, 0.09-0.67]; P = .01). Treatment dose showed small to large effect sizes by outcome. Conclusions and Relevance: The IIDEA treatment did not change drug misuse but did improve secondary mental health and substance misuse outcomes for a heterogeneous population with moderate to severe symptoms; this finding provides a path for treating Latino immigrants with co-occurring mental health and substance misuse symptoms. Trial Registration: ClinicalTrials.gov Identifier: NCT02038855.

Use of homeopathy in organic dairy farming in Spain.

Organic farming principles promote the use of unconventional therapies as an alternative to chemical substances (which are limited by organic regulations), with homeopathy being the most extensive. Traditionally, Spain has had little faith in homeopathy but its use in organic farming is growing. Fifty-six Spanish organic dairy farmers were interviewed to obtain what we believe to be the first data on the use of homeopathy in organic dairy cattle in Spain. Only 32% of farms use some sort of alternative therapy (16.1% homeopathy, 10.7% phytotherapy and 5.3% using both therapies) and interestingly, a clear geographical pattern showing a higher use towards the East (similar to that in the human population) was observed. The main motivation to use homeopathy was the need to reduce chemical substances promoted by organic regulations, and the treatment of clinical mastitis being the principle reason. The number of total treatments was lower in farms using homeopathy compared with those applying allopathic therapies (0.13 and 0.54 treatments/cow/year respectively) and although the bulk SCC was significantly higher (p < 0.001) in these farms (161,826 and 111,218 cel/ml, respectively) it did not have any negative economical penalty for the farmer and milk quality was not affected complying with the required standards; on the contrary homeopathic therapies seems to be an alternative for reducing antibiotic treatments, allowing farmers to meet the organic farming principles.

Design and optimization of self-nanoemulsifying drug delivery systems (SNEDDS) for enhanced dissolution of gemfibrozil.

Self-nanoemulsifying drug delivery systems of gemfibrozil were developed under Quality by Design approach for improvement of dissolution and oral absorption. Preliminary screening was performed to select proper components combination. Box-Behnken experimental design was employed as statistical tool to optimize the formulation variables, X(1) (Cremophor(®) EL), X(2) (Capmul(®) MCM-C8), and X(3) (lemon essential oil). Systems were assessed for visual characteristics (emulsification efficacy), turbidity, droplet size, polydispersity index and drug release. Different pH media were also assayed for optimization. Following optimization, the values of formulation components (X(1), X(2), and X(3)) were 32.43%, 29.73% and 21.62%, respectively (16.22% of gemfibrozil). Transmission electron microscopy demonstrated spherical droplet morphology. SNEEDS release study was compared to commercial tablets. Optimized SNEDDS formulation of gemfibrozil showed a significant increase in dissolution rate compared to conventional tablets. Both formulations followed Weibull mathematical model release with a significant difference in t(d) parameter in favor of the SNEDDS. Equally amodelistic parameters were calculated being the dissolution efficiency significantly higher for SNEDDS, confirming that the developed SNEDDS formulation was superior to commercial formulation with respect to in vitro dissolution profile. This paper provides an overview of the SNEDDS of the gemfibrozil as a promising alternative to improve oral absorption.