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Placebo response

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https://www.readbyqxmd.com/read/29452166/metformin-ameliorates-the-progression-of-atherosclerosis-via-suppressing-macrophage-infiltration-and-inflammatory-responses-in-rabbits
#1
Qiangbing Yang, Hongming Yuan, Mao Chen, Jiali Qu, He Wang, Biao Yu, Jiahuan Chen, Shengnan Sun, Xiaochun Tang, Wenzhi Ren
AIMS: The present study aimed to investigate the possible effects of metformin on the progression of atherosclerosis in a rabbit model. MAIN METHODS: Rabbits were randomly divided into three groups (n = 10): the control (Ctrl) group (fed with a chow diet), and two experimental groups, the AS group and the Met group (both received an atherogenic diet). After 2 weeks of acclimatization, the rabbits in the AS and Met groups were given a placebo and metformin, respectively, daily by gavage for 10 weeks...
February 13, 2018: Life Sciences
https://www.readbyqxmd.com/read/29452049/model-free-tests-of-equality-in-binary-data-under-an-incomplete-block-design
#2
Kung-Jong Lui, Lixia Zhu
Using Prescott's model-free approach, we develop an asymptotic procedure and an exact procedure for testing equality between treatments with binary responses under an incomplete block crossover design. We employ Monte Carlo simulation and note that these test procedures can not only perform well in small-sample cases but also outperform the corresponding test procedures accounting for only patients with discordant responses published elsewhere. We use the data taken as a part of the crossover trial comparing two different doses of an analgesic with placebo for the relief of primary dysmenorrhea to illustrate the use of test procedures discussed here...
February 16, 2018: Journal of Biopharmaceutical Statistics
https://www.readbyqxmd.com/read/29451991/exogenous-ketone-salts-do-not-improve-cognitive-responses-after-a-high-intensity-exercise-protocol-in-healthy-college-aged-males
#3
Hunter S Waldman, Steven A Basham, Ffi G Price, JohnEric W Smith, Harish Chander, Adam C Knight, Ben M Krings, Matthew J McAllister
This study examined the effects of a D-ß-hydroxybutyrate (ßHB) containing beverage on cognitive and performance measures during a bout of repeated Wingates. Fifteen healthy, college-aged males (mean ± SD age: 23.1 ± 2.4 years, height: 165.4 ± 2.0 cm, mass: 81.4 ± 9.2 kg) volunteered for the present study. Trial 1 consisted of baseline measures and familiarization for the protocol. During trials 2 and 3, subjects reported to the laboratory, after a 10 h fast, and ingested 11.38 grams of ßHB or a placebo (PLA) beverage 30 min before exercise...
February 16, 2018: Applied Physiology, Nutrition, and Metabolism, Physiologie Appliquée, Nutrition et Métabolisme
https://www.readbyqxmd.com/read/29451967/cognitive-behavioral-therapy-for-anxiety-and-related-disorders-a-meta-analysis-of-randomized-placebo-controlled-trials
#4
REVIEW
Joseph K Carpenter, Leigh A Andrews, Sara M Witcraft, Mark B Powers, Jasper A J Smits, Stefan G Hofmann
The purpose of this study was to examine the efficacy of cognitive behavioral therapy (CBT) for anxiety-related disorders based on randomized placebo-controlled trials. We included 41 studies that randomly assigned patients (N = 2,843) with acute stress disorder, generalized anxiety disorder (GAD), obsessive compulsive disorder (OCD), panic disorder (PD), posttraumatic stress disorder (PTSD), or social anxiety disorder (SAD) to CBT or a psychological or pill placebo condition. Findings demonstrated moderate placebo-controlled effects of CBT on target disorder symptoms (Hedges' g = 0...
February 16, 2018: Depression and Anxiety
https://www.readbyqxmd.com/read/29451082/the-short-term-placebo-response-in-children-with-attention-deficit-hyperactivity-disorder-adhd
#5
Ayala Cohen, Moran Plonsky-Toder, Emanuel Tirosh
To assess short-term placebo response in 6- to 13-year-old children with ADHD, children who were administered a double-blind placebo-methylphenidate trial, 1 week each, were included in the analysis. Conners' parents and Teacher Rating scales, the Aggregate Neurobehavioral Student Health and Educational Review inventory, and the Matching Familiar Figure Test were employed. A reduction of 30% or more in one or more of the teachers report subscales was observed in 18.8% of the participants. Attention test performance resulted in 58% of children exhibiting reduction in error rates and 36...
January 1, 2018: Journal of Child Neurology
https://www.readbyqxmd.com/read/29451040/pulmonary-delivery-of-influenza-vaccine-formulations-in-cotton-rats-site-of-deposition-plays-a-minor-role-in-the-protective-efficacy-against-clinical-isolate-of-h1n1pdm-virus
#6
Yoshita Bhide, Jasmine Tomar, Wei Dong, Jacqueline de Vries-Idema, Henderik W Frijlink, Anke Huckriede, Wouter L J Hinrichs
Administration of influenza vaccines to the lungs could be an attractive alternative to conventional parenteral administration. In this study, we investigated the deposition site of pulmonary delivered liquid and powder influenza vaccine formulations and its relation to their immunogenicity and protective efficacy. In vivo deposition studies in cotton rats revealed that, the powder formulation was mainly deposited in the trachea ( ∼ 65%) whereas the liquid was homogenously distributed throughout the lungs ( ∼ 96%)...
November 2018: Drug Delivery
https://www.readbyqxmd.com/read/29450728/winter-vitamin-d-3-supplementation-does-not-increase-muscle-strength-but-modulates-the-igf-axis-in-young-children
#7
Charlotte Mortensen, Christian Mølgaard, Hanne Hauger, Michael Kristensen, Camilla T Damsgaard
PURPOSE: To explore whether muscle strength, the insulin-like growth factor axis (IGF-axis), height, and body composition were associated with serum 25-hydroxyvitamin D [25(OH)D] and affected by winter vitamin D supplementation in healthy children, and furthermore to explore potential sex differences. METHODS: We performed a double-blind, placebo-controlled, dose-response winter trial at 55ºN. A total of 117 children aged 4-8 years were randomly assigned to either placebo, 10, or 20 µg/day of vitamin D 3 for 20 weeks...
February 15, 2018: European Journal of Nutrition
https://www.readbyqxmd.com/read/29449193/phase-i-trial-of-intrathecal-mesenchymal-stem-cell-derived-neural-progenitors-in-progressive-multiple-sclerosis
#8
Violaine K Harris, James Stark, Tamara Vyshkina, Leslie Blackshear, Gloria Joo, Valentina Stefanova, Gabriel Sara, Saud A Sadiq
BACKGROUND: Multiple sclerosis (MS) is an immune-mediated demyelinating disease of the central nervous system and is one of the leading causes of disability in young adults. Cell therapy is emerging as a therapeutic strategy to promote repair and regeneration in patients with disability associated with progressive MS. METHODS: We conducted a phase I open-label clinical trial investigating the safety and tolerability of autologous bone marrow mesenchymal stem cell-derived neural progenitor (MSC-NP) treatment in 20 patients with progressive MS...
February 3, 2018: EBioMedicine
https://www.readbyqxmd.com/read/29448238/parsing-the-heterogeneity-of-depression-an-exploratory-factor-analysis-across-commonly-used-depression-rating-scales
#9
Elizabeth D Ballard, Julia S Yarrington, Cristan A Farmer, Marc S Lener, Bashkim Kadriu, Níall Lally, Deonte Williams, Rodrigo Machado-Vieira, Mark J Niciu, Lawrence Park, Carlos A Zarate
BACKGROUND: Due to the heterogeneity of depressive symptoms-which can include depressed mood, anhedonia, negative cognitive biases, and altered activity levels-researchers often use a combination of depression rating scales to assess symptoms. This study sought to identify unidimensional constructs measured across rating scales for depression and to evaluate these constructs across clinical trials of a rapid-acting antidepressant (ketamine). METHODS: Exploratory factor analysis (EFA) was conducted on baseline ratings from the Beck Depression Inventory (BDI), the Hamilton Depression Rating Scale (HAM-D), the Montgomery-Asberg Depression Rating Scale (MADRS), and the Snaith-Hamilton Pleasure Rating Scale (SHAPS)...
February 5, 2018: Journal of Affective Disorders
https://www.readbyqxmd.com/read/29447199/short-term-repeated-hrv-16-exposure-results-in-an-attenuated-immune-response-in-vivo-in-humans
#10
Rebecca M Koch, Matthijs Kox, Corné van den Kieboom, Gerben Ferwerda, Jelle Gerretsen, Sandra Ten Bruggencate, Johannes G van der Hoeven, Marien I de Jonge, Peter Pickkers
INTRODUCTION: Naturally, development of adaptive immunity following HRV infection affects the immune response. However, it is currently unclear whether or not HRV re-exposure within a short time frame leads to an altered innate immune response. The "experimental cold model" is used to investigate the pathogenesis of HRV infection and allows us to investigate the effects of repeated exposure on both local and systemic innate immunity. METHODS: 40 healthy male and female (1:1) subjects were nasally inoculated with HRV-16 or placebo...
2018: PloS One
https://www.readbyqxmd.com/read/29446830/prior-ingestion-of-exogenous-ketone-monoester-attenuates-the-glycemic-response-to-an-oral-glucose-tolerance-test-in-healthy-young-individuals
#11
Etienne Myette-Côté, Helena Neudorf, Hossein Rafiei, Kieran Clarke, Jonathan Peter Little
The main objectives of this study were threefold: (1) To determine whether acute ingestion of K me ; (R)-3-hydroxybutyl (R)-3-hydroxybutyrate impacts plasma glucose levels during a standardized oral glucose tolerance test (OGTT). (2) To compare changes in insulin concentrations and estimates of insulin sensitivity after acute K me supplementation. Twenty healthy participants (n = 10 males/females) aged between 18-35 years took part in a randomized crossover study. After an overnight fast, participants consumed a K me supplement (ΔG®; 0...
February 15, 2018: Journal of Physiology
https://www.readbyqxmd.com/read/29446469/clinical-trials-in-allergen-immunotherapy-current-concepts-and-future-needs
#12
REVIEW
O Pfaar, M Alvaro, V Cardona, E Hamelmann, R Mösges, J Kleine-Tebbe
Allergen immunotherapy (AIT) is a safe, effective treatment for allergic rhinoconjunctivitis and allergic asthma. However, AIT's clinical effect is still contested - primarily due to heterogeneity in clinical trial designs, study populations, therapeutic formulations and efficacy criteria. After discussing current concepts and unmet needs, an international panel of experts made several recommendations: (i) explore and validate definitions for [clinical] responders in AIT-trials; (ii) use of well-documented, standardized provocation tests prior to inclusion of subjects with relevant diseases in AIT trials; (iii) monitoring neo-sensitizations and occurrence of new allergy in extended AIT trials, and exclusion of polyallergic participants; (iv) validation of allergen exposure chambers with regard to natural exposure; (v) in studies of seasonal allergies, focus on peak exposure but also consider organising two parallel, geographically distinct but otherwise identical trials; (vi) discuss adaptive trial designs with the regulatory authorities; (vii) use e-health and m-health technologies to capture more information on individual exposure to allergens; (viii) initiate research on potential psychological, biochemical, immune, neural and even genomic markers of the placebo response; (ix) identify trial designs and primary endpoints that will give children with allergies easier, faster access to AIT formulations; and (x) promote and apply standardized methods for reporting systemic and local adverse events...
February 15, 2018: Allergy
https://www.readbyqxmd.com/read/29445836/bone-loss-after-romosozumab-denosumab-effects-of-bisphosphonates
#13
Anne M Horne, Borislav Mihov, Ian R Reid
Romosozumab and denosumab are monoclonal antibodies for the treatment of osteoporosis. Both have a rapid offset of effect resulting in loss of bone density (BMD) gained on-treatment and, in some cases, multiple vertebral fractures following treatment cessation. We recently reported disappointing results from transitioning patients from denosumab to intravenous zoledronate at the time the next denosumab injection is due. The present report re-assesses the role of bisphosphonates following the use of denosumab...
February 14, 2018: Calcified Tissue International
https://www.readbyqxmd.com/read/29444414/no-individual-or-combined-effects-of-caffeine-and-beetroot-juice-supplementation-during-submaximal-or-maximal-running
#14
Johanna Oskarsson, Kerry McGawley
BACKGROUND: Dietary supplements such as caffeine and beetroot juice are used by athletes in an attempt to optimize performance and therefore gain an advantage in competition. AIM: To investigate the individual and combined effects of caffeine and beetroot-juice supplementation during submaximal and maximal treadmill running. METHODS: Seven males (VO<sub>2max</sub>: 59.0 ± 2.9 mL/kg/min) and two females (VO<sub>2max</sub>: 53...
February 14, 2018: Applied Physiology, Nutrition, and Metabolism, Physiologie Appliquée, Nutrition et Métabolisme
https://www.readbyqxmd.com/read/29443445/aspirin-withdrawal-in-patients-treated-with-ticagrelor-presenting-with-non-st-elevation-myocardial-infarction
#15
Roy Beigel, Israel Mazin, Edward Koifman, Michael Shechter, Hanna Pres, Nir Shlomo, Nurit Rosenberg, Elad Asher, Shlomi Matetzky
BACKGROUND: Recent studies have shown that the thromboxaneA 2 -dependent pathway is dependent upon the adenosine diphosphate (ADP)-P2Y 12 pathway and that strong P2Y 12 receptor blockade alone causes inhibition of platelet aggregation that is minimally enhanced by aspirin. Data from the PLATO trial suggested that among ticagrelor-treated patients, high compared with low dose (<100mg\day) aspirin is associated with increased risk for ischemic events. OBJECTIVES: In the current prospective, randomized, placebo-controlled, double-blind, cross-over study, we sought to evaluate the impact of aspirin withdrawal on platelet reactivity in acute coronary syndrome (ACS) patients treated with a potent P2Y 12 blocker...
February 14, 2018: Journal of Thrombosis and Haemostasis: JTH
https://www.readbyqxmd.com/read/29441949/effect-of-serotonin-transporter-genotype-on-self-reported-efficacy-and-activity-changes-of-brain-prefrontal-area-in-response-to-placebo
#16
M Isawa, R Tashiro, C Naruse, Y Yamaguchi, H Itoh, T Nishimura, M Tomi, H Shimada, H Saito, M Mochizuki, E Nakashima
Patients benefit from drug therapy not only through pharmacological mechanisms, but also through non-pharmacological action (placebo effect), which may be mediated in part by the prefrontal area of the brain. We consider that the difference between responders and non-responders to placebo might be related to polymorphisms in the serotonin transporter-linked polymorphic region (5-HTTLPR). To study this idea, we performed a randomized double-blind clinical trial using caffeine and lactose (placebo). Activity in the prefrontal area of the brain was measured in terms of blood flow by means of near-infrared spectroscopy (NIRS) as an objective indicator...
January 2, 2018: Die Pharmazie
https://www.readbyqxmd.com/read/29441450/photobiomodulation-improves-motor-response-in-patients-with-spinal-cord-injury-submitted-to-electromyographic-evaluation-randomized-clinical-trial
#17
Fernanda Cordeiro da Silva, Andréa Oliver Gomes, Paulo Roberto da Costa Palácio, Fabiano Politti, Daniela de Fátima Teixeira da Silva, Raquel Agnelli Mesquita-Ferrari, Kristianne Porta Santos Fernandes, Sandra Kalil Bussadori
Photobiomodulation is a treatment that has been widely used in neurotrauma and neurodegenerative diseases. In the present study, low-level laser therapy was administered to patients with spinal cord injury. Twenty-five individuals were divided into two groups: placebo photobiomodulation plus physiotherapy and active photobiomodulation plus physiotherapy. Electromyographic evaluations were performed before and after 12 sessions of phototherapy as well as 30 days after the end of treatment. In the active phototherapy group, median frequency values of the brachial biceps and femoral quadriceps muscles were higher at rest and during isotonic contraction 30 days after photobiomodulation (p = 0...
February 13, 2018: Lasers in Medical Science
https://www.readbyqxmd.com/read/29441161/canakinumab-and-cardiovascular-outcomes-results-of-the-cantos-trial
#18
Syed Raza Shah, Zainab Abbasi, Mazia Fatima, Rohan Kumar Ochani, Waqas Shahnawaz, Muhammad Asim Khan, Syed Arbab Shah
IL-1 cytokines are mainly responsible for controlling a series of pro-inflammatory reactions induced in response to pathogen mediated tissue injury. Among the IL-1 cytokine family, IL-1 β results in upregulation of genes responsible for boosting immune system reactivity and inflammatory response. With growing pathophysiological relevance of IL-1β in a myriad of disease pathogenesis, new biological drugs have been developed in recent years. One such drug, Canakinumab, targeting IL-1β has been recently approved for clinical use...
2018: Journal of Community Hospital Internal Medicine Perspectives
https://www.readbyqxmd.com/read/29440887/long-term-health-related-quality-of-life-and-symptom-response-profiles-with-arformoterol-in-copd-results-from-a-52-week-trial
#19
James F Donohue, Vamsi K Bollu, Donald E Stull, Lauren M Nelson, Valerie Sl Williams, Michael D Stensland, Nicola A Hanania
Background: Symptom severity is the largest factor in determining subjective health in COPD. Symptoms (eg, chronic cough, dyspnea) are associated with decreased health-related quality of life (HRQoL). We evaluated the impact of arformoterol on HRQoL in COPD patients, measured by St George's Respiratory Questionnaire (SGRQ). Post hoc growth mixture model (GMM) analysis examined symptom response profiles. Methods: We examined data from a randomized, double-blind, parallel-group, 12-month safety trial of twice-daily nebulized arformoterol 15 µg (n=420) versus placebo (n=421)...
2018: International Journal of Chronic Obstructive Pulmonary Disease
https://www.readbyqxmd.com/read/29438771/chronic-inducible-urticaria-a-systematic-review-of-treatment-options
#20
REVIEW
Corinna Dressler, Ricardo Niklas Werner, Lisa Eisert, Torsten Zuberbier, Alexander Nast, Marcus Maurer
BACKGROUND: Chronic inducible urticaria (CindU) is a condition characterized by the appearance of recurrent wheals, angioedema or both, as a response to specific and reproducible triggers. OBJECTIVE: To systematically assess the evidence on the efficacy and safety of treatment options for CindU. Results were used to inform the 2017 update of "The EAACI/GA 2 LEN/EDF/WAO Guideline for the definition, classification, diagnosis and management of Urticaria." METHODS: Randomised controlled trials (RCTs) and controlled studies (CCTs) were systematically searched in various databases...
February 10, 2018: Journal of Allergy and Clinical Immunology
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