scholarly journals Application of an Inter-Species Extrapolation Method for the Prediction of Drug Interactions between Propolis and Duloxetine in Humans

2020 ◽  
Vol 21 (5) ◽  
pp. 1862
Author(s):  
Thi Lien Ngo ◽  
Chung-Hee Lee ◽  
Nayoung Han ◽  
Hyun-Moon Back ◽  
Su-Jin Rhee ◽  
...  
Keyword(s):  
Functional Foods ◽  
Allometric Scaling ◽  
Liver Blood Flow ◽  
Potent Effect ◽  
Safety Issues ◽  
Treatment Of Depression ◽  
Species Extrapolation ◽  
Potent Drug ◽  
High Doses ◽  
P450 Isozymes

Duloxetine (DLX) is a potent drug investigated for the treatment of depression and urinary incontinence. DLX is extensively metabolized in the liver by two P450 isozymes, CYP2D6 and CYP1A2. Propolis (PPL) is one of the popular functional foods known to have effects on activities of CYPs, including CYP1A2. Due to the high probability of using DLX and PPL simultaneously, the present study was designed to investigate the potent effect of PPL on pharmacokinetics (PKs) of DLX after co-administration in humans. A PK study was first conducted in 18 rats (n = 6/group), in which the plasma concentration of DLX and its major metabolite 4-hydroxy duloxetine (4-HD) with or without administration of PPL was recorded. Population PKs and potential effects of PPL were then analyzed using NONMEM software. Lastly, these results were extrapolated from rats to humans using the allometric scaling and the liver blood flow method. PPL (15,000 mg/day) exerts a statistically significant increase in DLX exposures at steady state, with a 20.2% and 24.6% increase in DLX C m a x , s s and the same 28.0% increase in DLX A U C s s when DLX (40 or 60 mg) was administered once or twice daily, respectively. In conclusion, safety issues are required to be attended to when individuals simultaneously use DLX and PPL at high doses, and the possibility of interactions between DLX and PPL might be noted.

Tools for risk assessment in radiation therapy

2012 ◽  
Vol 41 (3-4) ◽  
pp. 197-207 ◽  
Author(s):  
P. Ortiz López
Keyword(s):  
Radiation Therapy ◽  
Radiological Protection ◽  
Quality And Safety ◽  
Energy Agency ◽  
Safety Issues ◽  
Safety Programme ◽  
Specific Safety ◽  
High Doses ◽  
Very High ◽  
Icrp Publication

Radiotherapy has unquestionable benefits, but it is also associated with unique and specific safety issues. It is the only application of radiation in which humans are intentionally delivered very high doses. Safety in radiotherapy remains heavily dependent on human actions. A step-by-step approach is suggested for the prevention of accidental exposures in radiation therapy: (1) allocation of responsibilities to qualified professionals, and design of a quality and safety programme - no radiotherapy practice should be operated without these key elements; (2) use of the lessons from accidental exposures to test whether the quality and safety programme is sufficiently robust against these types of events –publications by the International Commission on Radiological Protection (ICRP) and the International Atomic Energy Agency provide a collection of lessons to facilitate this step; and (3) find other latent risks by posing the questions ‘What else could go wrong?’ or ‘What other potential hazards might be present?’ in a systematic, anticipative manner - methods to do so are described briefly in ICRP Publication 112.

scholarly journals Evaluation of Treatment Descriptions and Alignment With Clinical Guidance of Apps for Depression on App Stores: Systematic Search and Content Analysis (Preprint)

2019 ◽  
Author(s):  
Dionne Bowie-DaBreo ◽  
Sandra I Sünram-Lea ◽  
Corina Sas ◽  
Heather Iles-Smith
Keyword(s):  
Content Analysis ◽  
Treatment Strategies ◽  
Treatment Fidelity ◽  
Evidence Base ◽  
Great Promise ◽  
Nice Guidelines ◽  
Safety Issues ◽  
Clinical Guidance ◽  
App Store ◽  
Treatment Of Depression

BACKGROUND The use of apps for the treatment of depression shows great promise. However, there is uncertainty regarding the alignment of publicly available apps for depression with clinical guidance, their treatment fidelity and evidence base, and their overall safety. OBJECTIVE Built on previous analyses and reviews, this study aims to explore the treatment and safety issues of publicly available apps for depression. METHODS We conducted a content analysis of apps for depression in the 2 main UK app stores (Google Play and Apple App Store). App store listings were analyzed for intervention content, treatment fidelity, and fit with the National Institute for Health and Care Excellence (NICE) guidelines for the treatment of depression in adults. RESULTS A total of 353 apps for depression were included in the review. App descriptions reported the use of 20 treatment approaches and 37 treatment strategies. Many apps used transdiagnostic (155/353, 43.9%) and multitheoretical interventions to treat multiple disorders including depression. Although many interventions appeared to be evidence-informed, there were issues with treatment fidelity, research evidence, and fit with clinical guidelines. None of the apps fully aligned with the NICE guidelines for depression. CONCLUSIONS App developers have adopted many evidence-informed treatments in their interventions; however, more work is needed to improve clinical validity, treatment fidelity, and the safety of apps. We urge developers to consult relevant guidelines and standards, and to engage in reflective questioning on treatment and safety to address these issues and to improve treatment content and intervention design.

Safety issues of botanicals and botanical preparations in functional foods

Toxicology ◽  
2004 ◽  
Vol 198 (1-3) ◽  
pp. 213-220 ◽  
Author(s):  
R Kroes ◽  
R Walker
Keyword(s):  
Functional Foods ◽  
Safety Issues

Cardiovascular Safety of Plant Sterol and Stanol Consumption

2015 ◽  
Vol 98 (3) ◽  
pp. 739-741 ◽  
Author(s):  
Guenther Silbernagel ◽  
Iris Baumgartner ◽  
Winfried März
Keyword(s):  
Plant Sterol ◽  
Functional Foods ◽  
Cardiovascular Health ◽  
Low Density Lipoprotein ◽  
Density Lipoprotein ◽  
Plant Sterols ◽  
Lipoprotein Cholesterol ◽  
Low Density ◽  
Low Density Lipoprotein Cholesterol ◽  
Safety Issues

Abstract Plant sterols and stanols as components of functional foods are widely used for cholesterol lowering. The regular intake of these functional foods is associated with a decrease in low density lipoprotein cholesterol of about 10 % and an increase in plasma plant sterol or stanol concentrations by about a factor of 2. There is no doubt that a decrease in low density lipoprotein cholesterol is beneficial to cardiovascular health. However, due to the concomitant increase in circulating plant sterols safety issues associated with the intake of plant sterol containing functional foods have been raised. Herein, we will review and evaluate those arguments raised against the use of plant sterols and stanols.

scholarly journals Evaluation of Treatment Descriptions and Alignment With Clinical Guidance of Apps for Depression on App Stores: Systematic Search and Content Analysis

10.2196/14988 ◽  
2020 ◽  
Vol 4 (11) ◽  
pp. e14988 ◽  
Author(s):  
Dionne Bowie-DaBreo ◽  
Sandra I Sünram-Lea ◽  
Corina Sas ◽  
Heather Iles-Smith
Keyword(s):  
Content Analysis ◽  
Treatment Strategies ◽  
Treatment Fidelity ◽  
Evidence Base ◽  
Great Promise ◽  
Nice Guidelines ◽  
Safety Issues ◽  
Clinical Guidance ◽  
App Store ◽  
Treatment Of Depression

Background The use of apps for the treatment of depression shows great promise. However, there is uncertainty regarding the alignment of publicly available apps for depression with clinical guidance, their treatment fidelity and evidence base, and their overall safety. Objective Built on previous analyses and reviews, this study aims to explore the treatment and safety issues of publicly available apps for depression. Methods We conducted a content analysis of apps for depression in the 2 main UK app stores (Google Play and Apple App Store). App store listings were analyzed for intervention content, treatment fidelity, and fit with the National Institute for Health and Care Excellence (NICE) guidelines for the treatment of depression in adults. Results A total of 353 apps for depression were included in the review. App descriptions reported the use of 20 treatment approaches and 37 treatment strategies. Many apps used transdiagnostic (155/353, 43.9%) and multitheoretical interventions to treat multiple disorders including depression. Although many interventions appeared to be evidence-informed, there were issues with treatment fidelity, research evidence, and fit with clinical guidelines. None of the apps fully aligned with the NICE guidelines for depression. Conclusions App developers have adopted many evidence-informed treatments in their interventions; however, more work is needed to improve clinical validity, treatment fidelity, and the safety of apps. We urge developers to consult relevant guidelines and standards, and to engage in reflective questioning on treatment and safety to address these issues and to improve treatment content and intervention design.

Pharmacokinetics of β-Receptor-Blocking Agents in Relation to Their Anti-Hypertensive Effect

1976 ◽  
Vol 51 (s3) ◽  
pp. 473s-475s
Author(s):  
R. Gugler ◽  
G. Bodem ◽  
H. J. Dengler
Keyword(s):  
Liver Blood Flow ◽  
Systemic Availability ◽  
Receptor Blockade ◽  
Hypertensive Patients ◽  
Receptor Blocking ◽  
First Pass ◽  
High Doses ◽  
Β Receptor ◽  
Plasma Half Life ◽  
Propranolol Therapy

1. β-Receptor-blocking drugs are rapidly and completely absorbed after oral administration. Systemic availability is nevertheless incomplete for propranolol, alprenolol and oxprenolol, owing to ‘first-pass’ extraction by the liver. 2. Plasma half-life is between 2 and 4 h, except for sotalol (10–12 h). Plasma elimination of propranolol is reduced with decreased liver blood flow, observed in congestive heart failure or during chronic propranolol therapy itself. 3. β-Receptor blockade is usually achieved in these concentration ranges: propranolol and alprenolol, 50–100 ng/ml; oxprenolol, 500–1000 ng/ml; pindolol, 10–30 ng/ml; sotalol, 2–6 μg/ml. Higher concentrations are often found with high doses administered to hypertensive patients.

scholarly journals Cannabis infused foods and drinks: Food safety and the endocannabinoid system

2018 ◽  
Vol 4 ◽  
Author(s):  
Larry Holbrook ◽  
Michael Kani
Keyword(s):  
Health Care ◽  
Health Care Professionals ◽  
Functional Foods ◽  
Training Programs ◽  
Endocannabinoid System ◽  
Consumer Perception ◽  
Safety Issues ◽  
The Public ◽  
Physiological Regulator ◽  
Product And Process

Until recently, consumer perception of cannabis was largely framed by its stigma surrounding drug use. Today, in an era of medical and recreational cannabis legalization, an increasing commercialization of cannabis-based products are being purported as functional foods. It is important for a wider audience of researchers, health care professionals, regulators and industry stakeholders to enhance their awareness of the human endocannabinoid system as a physiological regulator, the safety issues of product and process methods and adherence to qualitycontrolled training programs for assuring the public of safe practices.

Stress in the brain: implications for treatment of depression

2002 ◽  
Vol 14 (4) ◽  
pp. 155-166 ◽  
Author(s):  
Er de Kloet
Keyword(s):  
Cognitive Performance ◽  
Brain Regions ◽  
Stress System ◽  
Stress Hormone ◽  
Negative Consequences ◽  
Early Life Programming ◽  
Treatment Of Depression ◽  
High Doses ◽  
New Generation ◽  
The Brain

A fundamental question in stress research is when the glucocorticoid stress hormone (cortisol in man) stops being neuroprotective and becomes harmful to the brain with negative consequences for cognition and mood. To address this question Section 1 focuses on the action mechanism of glucocorticoids. These hormones act via high and low affinity nuclear receptors, which regulate gene transcription in a coordinate manner. The receptors are expressed abundantly in hippocampus, amygdala and frontal cortex involved in cognitive processes. In Section 2 hypercortisolism is considered a potential disease factor for about 50% of the patients suffering from major depression. Recent data show that these patients recover within a few days when excess cortisol action is blocked with high doses of an antiglucocorticoid. Section 3 concerns animal models with ‘depression-like’ features of hypercorticism generated by manipulation of gene X environment inputs. Using gene expression profiling technology in the hippocampal transcriptome of these animals we identified about 700 potential targets for antidepressants out of 30 000 detectable gene products. One of our models is based on early life programming of the stress system. Rats exposed as pups to maternal deprivation display at senescence an enhanced individual difference in cognitive performance. The maternally deprived senescent animals age either successfully or become senile, at the expense of the average performance of non-deprived controls. The essay is concluded with the notion that the new generation of antidepressants ameliorates specific psychic dysfunctions (e.g. cognitive performance) linked to aberrant stress hormone action in discrete brain regions.

scholarly journals Blood levels of patients with profound refractory OCD who are on supra-normal dosages of sertraline

2017 ◽  
Vol 41 (S1) ◽  
pp. S409-S409 ◽  
Author(s):  
L. Drummond ◽  
V. Robert
Keyword(s):  
Therapeutic Range ◽  
Blood Levels ◽  
Inpatient Service ◽  
Exposure And Response Prevention ◽  
Obsessive Compulsive ◽  
Treatment Of Depression ◽  
Treatment Refractory ◽  
Competing Interest ◽  
High Doses ◽  
Higher Doses

IntroductionPatients with OCD usually require higher dosages of serotonin reuptake inhibiting (SRI) drugs than is used for the treatment of depression. This observation resulted in treatment-refractory patients being occasional prescribed selective SRI drugs above the normal upper limit of prescribing. Previous studies have shown that these high doses are well tolerated.ObjectivesWe decided to investigate the blood levels of patients on dosages of sertraline that were above the normal therapeutic range.MethodSuccessive patients treated by the National Inpatient Service for OCD/BDD who were treatment refractory and prescribed > 200 mg sertraline per day were included. All had previously received 2+ trials of different SRIs for > 3months each as well as been offered augmentation with dopamine blockers and at 2+ trials of exposure and response-prevention. All patients scored in the profoundly ill range of the Yale Brown Obsessive Compulsive Scale.Sertraline was titrated in 50 mg increases every 2–4 weeks up to a maximum of 400 mg. Blood samples were taken after their morning dose. This was after the patients had stabilised for at least 2 weeks on the higher doses.ResultsSeventeen patients were included in the study and received sertraline dosages ranging from 225 mg to 400 mg per day. Blood levels were within therapeutic range or below for all patients. Following treatment within the service, these patients generally showed an improvement of an average of improvement of 43% on the YBOCS.ConclusionsA subgroup of patients with profound refractory OCD seem to either malabsorb or rapidly metabolise sertraline resulting in lower than therapeutic blood levels.Disclosure of interestThe authors have not supplied their declaration of competing interest.

scholarly journals Effects of the Aphanizomenon flos-aquae Extract (Klamin®) on a Neurodegeneration Cellular Model

2018 ◽  
Vol 2018 ◽  
pp. 1-14 ◽  
Author(s):  
D. Nuzzo ◽  
G. Presti ◽  
P. Picone ◽  
G. Galizzi ◽  
E. Gulotta ◽  
...  
Keyword(s):  
Oxidative Stress ◽  
Nuclear Localization ◽  
Functional Foods ◽  
Protective Role ◽  
Bioactive Molecules ◽  
Ros Generation ◽  
Aggregation Kinetics ◽  
Cellular Model ◽  
Amyloid A ◽  
High Doses

Cyanobacteria have been recognized as a source of bioactive molecules to be employed in nutraceuticals, pharmaceuticals, and functional foods. An extract of Aphanizomenon flos-aquae (AFA), commercialized as Klamin®, was subjected to chemical analysis to determine its compounds. The AFA extract Klamin® resulted to be nontoxic, also at high doses, when administered onto LAN5 neuronal cells. Its scavenging properties against ROS generation were evaluated by using DCFH-DA assay, and its mitochondrial protective role was determined by JC-1 and MitoSOX assays. Klamin® exerts a protective role against beta amyloid- (Aβ-) induced toxicity and against oxidative stress. Anti-inflammatory properties were demonstrated by NFβB nuclear localization and activation of IL-6 and IL-1β inflammatory cytokines through ELISA. Finally, by using thioflavin T (ThT) and fluorimetric measures, we found that Klamin® interferes with Aβ aggregation kinetics, supporting the formation of smaller and nontoxic structures compared to toxic Aβ aggregates alone. Altogether, these data indicate that the AFA extract may play a protective role against mechanisms leading to neurodegeneration.

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