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Peter Sever, Ajay Gupta, David Thompson, Andrew Whitehouse, Tim Collier, Bjorn Dahlof, Neil Poulter
OBJECTIVE: To test the hypothesis that adverse effects of statins are only reported in excess in observational studies and not in blinded randomized trials. DESIGN AND METHOD: We collated all reported AEs in hypertensive patients in the Lipid-Lowering arm of the Anglo-Scandinavian Cardiac Outcomes Trial (ASCOT-LLA) during the randomised, double-blind phase (when atorvastatin was compared with placebo) and the subsequent non-randomised un-blinded LLA-extension phase (when patients were offered open-label statin)...
September 2016: Journal of Hypertension
E Carlino, A Piedimonte, F Benedetti
Placebos have long been considered a nuisance in clinical research, for they have always been used as comparators for the validation of new treatments. By contrast, today they represent an active field of research, and, due to the involvement of many mechanisms, the study of the placebo effect can actually be viewed as a melting pot of concepts and ideas for neuroscience. There is not a single placebo effect, but many, with different mechanisms across different medical conditions and therapeutic interventions...
2017: Handbook of Clinical Neurology
Laurent Misery, Jean-Luc Carré
In a viewpoint, Andrea Evers underlines how expectations and learned immune function can o ptimize dermatological treatments through the placebo effect, or induce opposite effects through nocebo effects. Going back to the first theories trying to explain the mechanisms of drugs addiction, she mentions patient expectations as well as conditioning processes. Placebo and nocebo effects are commonly studied indirectly in controlled double-blind trials. Their effects on objective symptoms are limited but are higher on subjective symptoms...
October 5, 2016: Experimental Dermatology
Xiulu Ruan, Lien Tran, Alan David Kaye
No abstract text is available yet for this article.
October 2016: Pain
Peter Sever, Ajay Gupta, David Thompson, Andrew Whitehouse, Tim Collier, Bjorn Dahlof, Neil Poulter
OBJECTIVE: To test the hypothesis that adverse effects of statins are only reported in excess in observational studies and not in blinded randomized trials. DESIGN AND METHOD: We collated all reported AEs in hypertensive patients in the Lipid-Lowering arm of the Anglo-Scandinavian Cardiac Outcomes Trial (ASCOT-LLA) during the randomised, double-blind phase (when atorvastatin was compared with placebo) and the subsequent non-randomised un-blinded LLA-extension phase (when patients were offered open-label statin)...
September 2016: Journal of Hypertension
Chris J Beedie, Philip Hurst, Damian Coleman, Abby Foad
No abstract text is available yet for this article.
May 2016: Medicine and Science in Sports and Exercise
Martina Amanzio, Sara Palermo, Ina Skyt, Lene Vase
It has been demonstrated that patients in the placebo arm of a clinical trial may experience adverse events (AEs), which may lead to nonadherence and dropout. However, so far, it is unknown to which extent this phenomenon is observed consistently across different diseases such as pain and neurodegenerative disorders.The current review shows for the first time that different diseases share a common risk for patients in terms of a negative outcome: a large percentage of placebo-treated patients experience AEs in pain conditions (up to 59%) and neurodegenerative disorders (up to 66%)...
October 2016: Journal of Clinical Psychopharmacology
Jeann L C Sabino-Carvalho, Thiago R Lopes, Tiago O Freitas, Thiago H N Ferreira, José E Succi, Antônio C Silva, Bruno M Silva
PURPOSE: Recent studies have reported ischemic preconditioning (IPC) can acutely improve endurance exercise performance in athletes. However, placebo and nocebo effects have not been sufficiently controlled, and the effect on aerobic metabolism parameters that determine endurance performance [e.g., oxygen cost of running, lactate threshold, and maximal oxygen uptake (V[Combining Dot Above]O2max)] has been equivocal. Thus, we circumvented limitations from previous studies to test the effect of IPC on aerobic metabolism parameters and endurance performance in well-trained runners...
August 30, 2016: Medicine and Science in Sports and Exercise
Jonathan A Tobert, Connie B Newman
The nocebo effect, the inverse of the placebo effect, is a well-established phenomenon that is under-appreciated in cardiovascular medicine. It refers to adverse events, usually purely subjective, that result from expectations of harm from a drug, placebo, other therapeutic intervention or a nonmedical situation. These expectations can be driven by many factors including the informed consent form in a clinical trial, warnings about adverse effects communicated by clinicians when prescribing a drug, and information in the media about the dangers of certain treatments...
July 2016: Journal of Clinical Lipidology
C Sinke, K Schmidt, K Forkmann, U Bingel
BACKGROUND: Expectations can dramatically influence the perception of pain, as has been shown in placebo analgesia or nocebo hyperalgesia. Here, we investigated the role of expectation on the interruptive function of pain - the negative consequences of pain on cognitive task performance - in 42 healthy human subjects. METHODS: Verbal and written instructions were used to manipulate the subjects' expectation of how pain would influence their task performance in an established visual categorization task which was performed with or without concomitant painful thermal stimulation during 3T fMRI scanning...
August 26, 2016: European Journal of Pain: EJP
Sergiu Albu, Mary W Meagher
Changes in EEG activity have been related to clinical and experimental pain. Expectation of a negative outcome can lead to pain enhancement (nocebo hyperalgesia) and can alter the response to therapeutic interventions. The present study characterizes EEG alteration related to pain facilitation by nocebo. Thirty healthy subjects were randomly assigned to the nocebo or control group. Five-minute EEG was recorded under: resting state, tonic innocuous heat and tonic noxious heat before and after the application of a sham inert cream to the non-dominant volar forearm combined with cognitive manipulation...
August 22, 2016: International Journal of Psychophysiology
Y Nestoriuc, P von Blanckenburg, F Schuricht, A J Barsky, P Hadji, U-S Albert, W Rief
BACKGROUND: This study aims to determine the role of patient expectations as potentially modifiable factor of side-effects, quality of life, and adherence to endocrine treatment of breast cancer. PATIENTS AND METHODS: A 2-year prospective clinical cohort study was conducted in routine primary care with postoperative patients with hormone-receptor-positive breast cancer, scheduled to start adjuvant endocrine treatment. Structured patient-reported assessments of side-effects, side-effect expectations, quality of life, and adherence took place during the first week post-surgery and after 3 and 24 months of endocrine treatment...
October 2016: Annals of Oncology: Official Journal of the European Society for Medical Oncology
Javier Molina-Infante, Antonio Carroccio
A double-blind, placebo-controlled, gluten challenge has been proposed to confirm a diagnosis of non-celiac gluten sensitivity (NCGS) in patients without celiac disease who respond to a gluten-free diet. To determine the accuracy of this approach, we analyzed data from 10 double-blind, placebo-controlled, gluten challenge trials, comprising 1312 adults. The studies varied in the duration of the challenge (ranging from 1 day to 6 weeks), daily doses for the gluten challenge (ranging from 2 g to 52 g; 3 studies administered less than 8 g/day), and composition of the placebo (gluten-free products, xylose, whey protein, rice, or corn starch containing fermentable carbohydrates)...
August 11, 2016: Clinical Gastroenterology and Hepatology
Andrea W M Evers
The role of placebo and nocebo effects - i.e. positive or negative treatment effects that are entirely a consequence of the patient's expectations and beliefs about a treatment outcome in terms of efficacy, safety, usability, or side effects - has been shown for almost all types of diseases and physiological response systems. Evidence for the relevance of placebo and nocebo effects in dermatology is also increasing, particularly for symptoms of itch and learned (conditioned) immune function. In addition, increasing knowledge is available about the neurobiological mechanisms of action, such as the role of the dopaminergic system...
August 4, 2016: Experimental Dermatology
P van Eijsden, Y Smulders
There is ample evidence to support the notion that the context of a treatment influences the efficacy of that treatment. Most doctors feel uncomfortable with the intentional introduction of contextual elements that have no plausible biological effect, because it is not in line with their biomechanical world view and training. Withholding certain information to prevent nocebo effects may even go against our duty to inform patients. We argue that our primary duty is to serve the interest of our patients and that to withhold positive contextual elements or to introduce negative contextual elements conflicts with this duty...
2016: Nederlands Tijdschrift Voor Geneeskunde
Nicole Corsi, Mehran Emadi Andani, Michele Tinazzi, Mirta Fiorio
The nocebo effect in motor performance consists in a reduction of force and increase of fatigue following the application of an inert treatment that the recipient believes to be effective. This effect is variable across individuals and it is usually stronger if conditioning -exposure to the active effect of the treatment- precedes a test session, in which the treatment is inert. In the current explorative study we used a conditioning procedure to investigate whether subjective perception of treatment effectiveness changes between the conditioning and the test session and whether this change is related to dispositional traits and to the nocebo-induced reduction of force...
2016: Scientific Reports
Costanza Pazzaglia, Elisa Testani, Rocco Giordano, Luca Padua, Massimiliano Valeriani
Increased pain perception due to the expectation to feel more pain is called nocebo effect. The present study aimed at investigating whether: (1) the mere expectation to feel more pain after the administration of an inert drug can affect the laser-pain rating and the laser-evoked potential (LEP) amplitude, and (2) the learning potentiates the nocebo effect. Eighteen healthy volunteers were told that an inert cream, applied on the right hand, would increase the laser pain and LEP amplitude to right hand stimulation...
October 1, 2016: Neuroscience
D J David, D Gourion
Antidepressant therapy aims to reach remission of depressive symptoms while reducing the complications and risks of relapse. Even though they have proven their efficacy, it takes several weeks for antidepressants to demonstrate full effectiveness, and adverse effects occur more quickly or (quicker) which can be a source of poor compliance. This latest aspect often leads to dose reduction and/or change of molecule that have the effect of delaying remission. This review attempts to present, from the pharmacological properties of the major classes of antidepressants (monoamine oxidase inhibitor [MAOI], tricyclic antidepressants [TCA], selective serotonin reuptake inhibitor [SSRI] and serotonin and noradrenaline reuptake inhibitor [SNRI]), to the pharmacological mechanisms involved in adverse effects by focusing on sexual dysfunction, nausea/vomiting, and weight changes...
July 13, 2016: L'Encéphale
A Sölle, M Worm, H Flor, R Klinger
Research on placebo responses has made major progress in recent years. Placebo responses are psychobiological events, which are created by the entire therapeutic context. They can appear at any time, not only in experimental and clinical settings. Several studies on analgesia-related placebo research showed that patients have higher placebo responses in comparison to healthy participants, which may also last longer. Expectations play a key role in placebo analgesia. They can be induced via three central psychological mechanisms: 1) expectation induced via instructions, 2) expectation induced via classical conditioning and 3) expectation induced via social learning...
July 11, 2016: Der Schmerz
Renzo Zanotti, Daniele Chiffi
Nursing knowledge stems from a dynamic interplay between population-based scientific knowledge (the general) and specific clinical cases (the particular). We compared the 'cascade model of knowledge translation', also known as 'classical biomedical model' in clinical practice (in which knowledge gained at population level may be applied directly to a specific clinical context), with an emergentist model of knowledge translation. The structure and dynamics of nursing knowledge are outlined, adopting the distinction between epistemic and non-epistemic values...
July 4, 2016: Nursing Philosophy: An International Journal for Healthcare Professionals
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