scholarly journals Harnessing the placebo effect: the need for translational research

2011 ◽  
Vol 366 (1572) ◽  
pp. 1922-1930 ◽  
Author(s):  
Luana Colloca ◽  
Franklin G. Miller
Keyword(s):  
Clinical Practice ◽  
Translational Research ◽  
Placebo Effect ◽  
Clinical Setting ◽  
Routine Clinical Practice ◽  
Laboratory Research ◽  
Placebo Effects ◽  
Brain Areas ◽  
Nocebo Effects ◽  
Made In

Laboratory research recently has greatly enhanced the understanding of placebo and nocebo effects by identifying specific neuromodulators and brain areas associated with them. However, little progress has been made in translating this knowledge into improved patient care. Here, we discuss the limitations in our knowledge about placebo (and nocebo) effects and the need for translational research with the aim of guiding physicians in maximizing placebo effects and minimizing nocebo effects in their routine clinical practice. We suggest some strategies for how, when and why interventions to promote beneficial placebo responses might be administered in the clinical setting.

scholarly journals Placebo Analgesia—Understanding the Mechanisms and Implications for Clinical Practice

2009 ◽  
Vol 3 (2) ◽  
pp. 15-19 ◽  
Author(s):  
Damien G Finniss ◽  
Michael K Nicholas ◽  
Fabrizio Benedetti
Keyword(s):  
Clinical Practice ◽  
Placebo Effect ◽  
Clinical Care ◽  
Routine Clinical Practice ◽  
Routine Practice ◽  
Placebo Effects ◽  
Placebo Analgesia

• There are neurobiological, cognitive and conditioning processes involved in placebo mechanisms • Mechanisms research has demonstrated that there is not one placebo effect, but many • Placebo effects are an inherent element in routine clinical practice • Modulation of placebo mechanisms in routine practice could provide an opportunity for improving clinical care.

Diagnosis and Management of Cardiomyopathies – A Focus on Genetics, Cardiac Magnetic Resonance and Clinical Features

2011 ◽  
Vol 7 (3) ◽  
pp. 225
Author(s):  
Gianfranco Sinagra ◽  
Michele Moretti ◽  
Giancarlo Vitrella ◽  
Marco Merlo ◽  
Rossana Bussani ◽  
...  
Keyword(s):  
Clinical Practice ◽  
Cardiac Magnetic Resonance ◽  
Magnetic Resonance ◽  
Imaging Techniques ◽  
Molecular Genetic ◽  
Molecular Genetic Analysis ◽  
Routine Clinical Practice ◽  
Clinical Approach ◽  
Diagnosis And Management ◽  
Made In

In recent years, outstanding progress has been made in the diagnosis and treatment of cardiomyopathies. Genetics is emerging as a primary point in the diagnosis and management of these diseases. However, molecular genetic analyses are not yet included in routine clinical practice, mainly because of their elevated costs and execution time. A patient-based and patient-oriented clinical approach, coupled with new imaging techniques such as cardiac magnetic resonance, can be of great help in selecting patients for molecular genetic analysis and is crucial for a better characterisation of these diseases. This article will specifically address clinical, magnetic resonance and genetic aspects of the diagnosis and management of cardiomyopathies.

scholarly journals Influence of placebo analgesia in pharmacological treatment of pain

2020 ◽  
Vol 2 (2) ◽  
pp. FDD34
Author(s):  
Duncan Sanders ◽  
Luana Colloca ◽  
Damien G Finniss
Keyword(s):  
Clinical Practice ◽  
Drug Response ◽  
Clinical Effectiveness ◽  
Routine Clinical Practice ◽  
Placebo Effects ◽  
Placebo Analgesia ◽  
Drug Dosing ◽  
Belief Structures ◽  
Therapeutic Context ◽  
Potential Integration

Placebo effects are relevant to routine clinical practice, even if no traditional placebo is given. The healthcare encounter is often rich in factors that may affect both placebo and nocebo components of care, therefore, an opportunity exists to target elements of this encounter to enhance clinical effectiveness. This review will outline the contemporary conceptualizations of placebo and the mechanisms of placebo effects. Specifically, how to harness these placebo effects in clinical practice. Currently, these include optimizing the therapeutic context, shaping of expectations, assessing belief structures and framing information delivery, utilization of conditioning regimes to augment drug response or reduce overall drug dosing and the potential integration of traditional placebos with scientifically proven treatments to augment care.

scholarly journals Unethical informed consent caused by overlooking poorly measured nocebo effects

2020 ◽  
pp. medethics-2019-105903
Author(s):  
Jeremy Howick
Keyword(s):  
Clinical Trials ◽  
Clinical Practice ◽  
Informed Consent ◽  
Natural History ◽  
Adverse Events ◽  
Placebo Effect ◽  
Nocebo Effect ◽  
Control Groups ◽  
Nocebo Effects ◽  
Negative Outcome

Unlike its friendly cousin the placebo effect, the nocebo effect (the effect of expecting a negative outcome) has been almost ignored. Epistemic and ethical confusions related to its existence have gone all but unnoticed. Contrary to what is often asserted, adverse events following from taking placebo interventions are not necessarily nocebo effects; they could have arisen due to natural history. Meanwhile, ethical informed consent (in clinical trials and clinical practice) has centred almost exclusively on the need to inform patients about intervention risks with patients to preserve their autonomy. Researchers have failed to consider the harm caused by the way in which the information is conveyed. In this paper, I argue that the magnitude of nocebo effects must be measured using control groups consisting of untreated patients. And, because the nocebo effect can produce harm, the principle of non-maleficence must be taken into account alongside autonomy when obtaining (ethical) informed consent and communicating intervention risks with patients.

Cost-Effectiveness Analysis: Discount the Placebo at Your Peril

2010 ◽  
Vol 30 (5) ◽  
pp. 536-543 ◽  
Author(s):  
Neil Hawkins ◽  
David A. Scott
Keyword(s):  
Clinical Practice ◽  
Cost Effectiveness ◽  
Placebo Effect ◽  
Severe Disease ◽  
Quality Adjusted Life Year ◽  
Routine Clinical Practice ◽  
Regression To The Mean ◽  
Expectancy Effect ◽  
The Cost ◽  
Selection Of

Introduction: The authors consider alternative mechanisms that might explain placebo responses and their implications for cost-effectiveness modeling. Three alternative placebo mechanisms are examined: a ‘‘regression to the mean’’ effect arising from natural variation and the preferential selection of patients with acutely severe disease into clinical trials, a patient expectancy effect specific to the clinical trial setting (Hawthorne effect), and a patient expectancy effect generalizable to routine clinical practice (true placebo effect). Methods: To estimate cost-effectiveness, the authors needed to generalize from trial data to estimate responses to treatment that they would see in routine clinical practice. They use an example analysis of the cost-effectiveness of adjunct epilepsy treatments to illustrate the potential effects of these different placebo mechanisms on this generalization and subsequent cost-effectiveness estimates and adoption decisions. Results: If an acceptable willingness-to-pay threshold of 30,000 per quality-adjusted life year (QALY) is assumed, then each of the placebo effect scenarios identifies a different treatment alternative as being optimum. Discussion: Estimated cost-effectiveness ratios and associated policy decisions may be sensitive to assumptions regarding the mechanism underlying placebo responses. These assumptions should, if possible, be investigated through analysis of trial or observational data and, in the absence of other evidence, sensitivity analysis.

scholarly journals What Do Placebo and Nocebo Effects Have to Do With Health Equity? The Hidden Toll of Nocebo Effects on Racial and Ethnic Minority Patients in Clinical Care

2021 ◽  
Vol 12 ◽  
Author(s):  
Hailey E. Yetman ◽  
Nevada Cox ◽  
Shelley R. Adler ◽  
Kathryn T. Hall ◽  
Valerie E. Stone
Keyword(s):  
Clinical Setting ◽  
Clinical Care ◽  
Quality Care ◽  
Clinical Encounter ◽  
Medical Mistrust ◽  
Placebo Effects ◽  
Beneficial Effects ◽  
Unequal Treatment ◽  
Black Patients ◽  
Nocebo Effects

A placebo effect is a positive clinical response to non-specific elements of treatment with a sham or inert replica of a drug, device, or surgical intervention. There is considerable evidence that placebo effects are driven by expectation of benefit from the intervention. Expectation is shaped by a patient’s past experience, observations of the experience of others, and written, verbal, or non-verbal information communicated during treatment. Not surprisingly, expectation in the clinical setting is strongly influenced by the attitude, affect, and communication style of the healthcare provider. While positive expectations can produce beneficial effects, negative information and experiences can lead to negative expectations, and consequently negative or nocebo effects. Key components identified and studied in the placebo and nocebo literature intersect with factors identified as barriers to quality care in the clinical setting for Black patients and other patients of color, including poor patient-clinician communication, medical mistrust, and perceived discrimination. Thus, in the context of discrimination and bias, the absence of placebo and presence of nocebo-generating influences in clinical settings could potentially reinforce racial and ethnic inequities in clinical outcomes and care. Healthcare inequities have consequences that ripple through the medical system, strengthening adverse short- and long-term outcomes. Here, we examine the potential for the presence of nocebo effects and absence of placebo effects to play a role in contributing to negative outcomes related to unequal treatment in the clinical encounter.

Placebo Effects in Psychiatry and Psychotherapy

2013 ◽  
Author(s):  
David A. Jopling
Keyword(s):  
Placebo Effect ◽  
Placebo Effects ◽  
Open Label ◽  
Evolutionary Origins ◽  
Talk Therapy ◽  
Psychoactive Medication ◽  
New Directions ◽  
Made In

This chapter begins by debunking some of the myths and misconceptions surrounding placebo effects, through a survey of some of the discoveries that have been made in the last fifty years about the range, frequency, and potency of placebo effects in medicine and psychiatry. It then looks at how placebo effects make an appearance in psychiatry and psychotherapy, particularly in the case of treatments of depression that involve psychoactive medication and/or talk therapy. Following this is a survey of some of the leading definitions of the placebo effect, as well as a survey of some of the leading explanatory theories. The chapter concludes with a discussion of some new directions in placebo research: namely, open-label placebos and the evolutionary origins of placebo effects.

scholarly journals Placebo effects in chronic pain conditions. Can placebo components enhance the efficacy of active treatments?

2016 ◽  
Vol 12 (23) ◽  
Author(s):  
Ina Skyt ◽  
Lene Vase
Keyword(s):  
Chronic Pain ◽  
Clinical Practice ◽  
Healthy Volunteers ◽  
Placebo Effect ◽  
Brain Activation ◽  
Review Literature ◽  
Endogenous Opioids ◽  
Placebo Effects ◽  
Placebo Analgesia ◽  
Chronic Pain Conditions

The conceptualization of the placebo phenomenon has changed. Previously placebo was seen as an inactive agent, but today placebo effects are viewed as related to patients’ perception of a treatment. During the last decades, the mechanisms underlying placebo analgesia effects have been specified and it has been shown that patients’ perception of a treatment is influenced by previous experiences, the patient-practitioner relationship as well as expectations and emotions. These factors are, in turn, associated with altered brain activation and release of endogenous opioids, thereby demonstrating that placebo analgesia has a psycho-neurobiological basis. The placebo effect has primarily been investigated in relation to healthy volunteers, but here we review literature on placebo mechanisms in relation to chronic pain states as this is important for an understanding of how placebo factors can be optimized in clinical practice. We outline some of the ethical discussions concerning the use of placebo in clinical practice and we illustrate how patients perception of a treatment contribute to the efficacy of active treatments, thereby showing how focus on patients perception of a treatment may help optimize the outcome of standard active pain treatments in ethically appropriate ways.

scholarly journals Diagnostic Performance of Automated MRI Volumetry by icobrain dm for Alzheimer’s Disease in a Clinical Setting: A REMEMBER Study

2021 ◽  
pp. 1-17
Author(s):  
Mandy Melissa Jane Wittens ◽  
Diana Maria Sima ◽  
Ruben Houbrechts ◽  
Annemie Ribbens ◽  
Ellis Niemantsverdriet ◽  
...  
Keyword(s):  
Alzheimer’S Disease ◽  
Alzheimer's Disease ◽  
Clinical Practice ◽  
Diagnostic Accuracy ◽  
Clinical Setting ◽  
Diagnostic Performance ◽  
Brain Mri ◽  
Diagnostic Value ◽  
Routine Clinical Practice ◽  
Brain Volumes

Background: Magnetic resonance imaging (MRI) has become important in the diagnostic work-up of neurodegenerative diseases. icobrain dm, a CE-labeled and FDA-cleared automated brain volumetry software, has shown potential in differentiating cognitively healthy controls (HC) from Alzheimer’s disease (AD) dementia (ADD) patients in selected research cohorts. Objective: This study examines the diagnostic value of icobrain dm for AD in routine clinical practice, including a comparison to the widely used FreeSurfer software, and investigates if combined brain volumes contribute to establish an AD diagnosis. Methods: The study population included HC (n = 90), subjective cognitive decline (SCD, n = 93), mild cognitive impairment (MCI, n = 357), and ADD (n = 280) patients. Through automated volumetric analyses of global, cortical, and subcortical brain structures on clinical brain MRI T1w (n = 820) images from a retrospective, multi-center study (REMEMBER), icobrain dm’s (v.4.4.0) ability to differentiate disease stages via ROC analysis was compared to FreeSurfer (v.6.0). Stepwise backward regression models were constructed to investigate if combined brain volumes can differentiate between AD stages. Results: icobrain dm outperformed FreeSurfer in processing time (15–30 min versus 9–32 h), robustness (0 versus 67 failures), and diagnostic performance for whole brain, hippocampal volumes, and lateral ventricles between HC and ADD patients. Stepwise backward regression showed improved diagnostic accuracy for pairwise group differentiations, with highest performance obtained for distinguishing HC from ADD (AUC = 0.914; Specificity 83.0%; Sensitivity 86.3%). Conclusion: Automated volumetry has a diagnostic value for ADD diagnosis in routine clinical practice. Our findings indicate that combined brain volumes improve diagnostic accuracy, using real-world imaging data from a clinical setting.

How to run a placebo study

2020 ◽  
pp. 478-496
Author(s):  
Fabrizio Benedetti
Keyword(s):  
Clinical Trial ◽  
Placebo Effect ◽  
Clinical Setting ◽  
Experimental Designs ◽  
Placebo Effects ◽  
Clinical Trial Setting ◽  
Agonist And Antagonist ◽  
Underlying Mechanisms ◽  
Trial Setting

This chapter is addressed to those who want to run a study aimed at identifying the underlying mechanisms of placebo effects. To study a placebo effect requires specific designs that cannot be performed in the classic clinical trial setting. Complex experimental designs are particularly necessary when one wants to investigate the neurobiological mechanisms, for example by means of agonist and antagonist drugs. Complex pharmacological designs have used up to twelve experimental arms (groups) in order to answer specific questions. To study the role of learning in placebo effects, for example conditioning, one needs to control the associations between conditioned and unconditioned stimuli both in the experimental and in the clinical setting. In addition, several approaches are possible for hiding a therapy from the subject’s view, so that he is totally unaware that a treatment is being performed, thus allowing the investigation of placebo effects without the administration of placebos.

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