The placebo response in medicine: minimize, maximize or personalize?
TL;DR: Three strategies that could be used to modulate the placebo response, depending on which stage of the drug development process they are applied are discussed.
Abstract: The therapeutic outcome of a drug or procedure is influenced by the placebo response in both drug development and clinical practice. Enck and colleagues examine how the placebo response can be utilized in these settings to ensure that the most desirable outcome is attained. Our understanding of the mechanisms mediating or moderating the placebo response to medicines has grown substantially over the past decade and offers the opportunity to capitalize on its benefits in future drug development as well as in clinical practice. In this article, we discuss three strategies that could be used to modulate the placebo response, depending on which stage of the drug development process they are applied. In clinical trials the placebo effect should be minimized to optimize drug–placebo differences, thus ensuring that the efficacy of the investigational drug can be truly evaluated. Once the drug is approved and in clinical use, placebo effects should be maximized by harnessing patients' expectations and learning mechanisms to improve treatment outcomes. Finally, personalizing placebo responses — which involves considering an individual's genetic predisposition, personality, past medical history and treatment experience — could also maximize therapeutic outcomes.
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TL;DR: This dissertation aims to provide a history of the use of psychosomatic medicine and psychotherapy in the clinic and its applications in the field of medicine and therapy.
Abstract: a Department of Psychosomatic Medicine and Psychotherapy, University Medical Hospital Tübingen, Tübingen , b Department of General Internal Medicine and Psychosomatics, Heidelberg University Hospital, Heidelberg , c Department of Psychosomatic Medicine and Psychotherapy, University Hospital Giessen and Marburg, Giessen and Marburg , and d Department of Psychosomatic Medicine and Psychotherapy, Klinikum rechts der Isar, Technical University of Munich, Munich , Germany
537 citations
TL;DR: It is proposed that future anti-epileptic drug development may be improved through a new joint endeavour between academia and the industry, through the identification and application of tools for new target-driven approaches, and through comparative preclinical proof-of-concept studies and innovative clinical trials designs.
Abstract: Despite the introduction of over 15 third-generation anti-epileptic drugs, current medications fail to control seizures in 20-30% of patients. However, our understanding of the mechanisms mediating the development of epilepsy and the causes of drug resistance has grown substantially over the past decade, providing opportunities for the discovery and development of more efficacious anti-epileptic and anti-epileptogenic drugs. In this Review we discuss how previous preclinical models and clinical trial designs may have hampered the discovery of better treatments. We propose that future anti-epileptic drug development may be improved through a new joint endeavour between academia and the industry, through the identification and application of tools for new target-driven approaches, and through comparative preclinical proof-of-concept studies and innovative clinical trials designs.
511 citations
TL;DR: The idea that the ascending and the descending pain system resembles a recurrent system that allows for the implementation of predictive coding-meaning that the brain is not passively waiting for nociceptive stimuli to impinge on it but is actively making inferences based on prior experience and expectations.
317 citations
Cites background from "The placebo response in medicine: m..."
...Such a finding could potentially explain the large interindividual differences that have been observed in this domain (Enck et al., 2013)....
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...Introduction Placebo effects are a powerful illustration of the strong influence that expectations can have on treatment outcome and have therefore received enormous attention over the last decade, resulting in many comprehensive reviews on placebo effects in general (Benedetti, 2013; Colloca and Benedetti, 2005; Enck et al., 2013; Oken, 2008; Price et al., 2008), placebo hypoalgesia in particular (Carlino et al....
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...…attention over the last decade, resulting in many comprehensive reviews on placebo effects in general (Benedetti, 2013; Colloca and Benedetti, 2005; Enck et al., 2013; Oken, 2008; Price et al., 2008), placebo hypoalgesia in particular (Carlino et al., 2011; Colloca and Benedetti, 2005; Kong et…...
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TL;DR: The prevailing theoretical approach to this problem is described and a new and more comprehensive model of the body‐symptom relationship that integrates existing concepts within a unifying framework that addresses many of the shortcomings of current theory is proposed.
289 citations
Leiden University1, University of Maryland, Baltimore2, Beth Israel Deaconess Medical Center3, National Research Council4, University of Turin5, University of Duisburg-Essen6, University of Hamburg7, University of New South Wales8, Stanford University9, University of Basel10, University of Toledo11, University of Oxford12, Karolinska Institutet13, McGill University14, University of Marburg15, Aarhus University16, University of Colorado Boulder17, University of Wisconsin-Madison18
TL;DR: This paper forms a first step towards developing evidence-based and ethical recommendations about the implications of placebo and nocebo research for medical practice, based on the current state of evidence and the consensus of experts.
Abstract: Background: Placebo and nocebo effects occur in clinical or laboratory medical contexts after administration of an inert treatment or as part of active treatments and are due to psychobiological mechanisms such as expectancies of the patient. Placebo and nocebo studies have evolved from predominantly methodological research into a far-reaching interdisciplinary field that is unravelling the neurobiological, behavioural and clinical underpinnings of these phenomena in a broad variety of medical conditions. As a consequence, there is an increasing demand from health professionals to develop expert recommendations about evidence-based and ethical use of placebo and nocebo effects for clinical practice. Methods: A survey and interdisciplinary expert meeting by invitation was organized as part of the 1st Society for Interdisciplinary Placebo Studies (SIPS) conference in 2017. Twenty-nine internationally recognized placebo researchers participated. Results: There was consensus that maximizing placebo effects and minimizing nocebo effects should lead to better treatment outcomes with fewer side effects. Experts particularly agreed on the importance of informing patients about placebo and nocebo effects and training health professionals in patient-clinician communication to maximize placebo and minimize nocebo effects. Conclusions: The current paper forms a first step towards developing evidence-based and ethical recommendations about the implications of placebo and nocebo research for medical practice, based on the current state of evidence and the consensus of experts. Future research might focus on how to implement these recommendations, including how to optimize conditions for educating patients about placebo and nocebo effects and providing training for the implementation in clinical practice.
281 citations
References
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TL;DR: This study’s findings can provide practical guidelines to steer partnership programs within the academic and clinical bodies, with the aim of providing a collaborative partnership approach to clinical education.
Abstract: The aim of our systematic review was to retrieve and integrate relevant evidence related to the process of formation and implementation of the academic–service partnership, with the aim of reformin...
41,134 citations
TL;DR: The four articles in this special section onMeta-analysis illustrate some of the complexities entailed in meta-analysis methods and contributes both to advancing this methodology and to the increasing complexities that can befuddle researchers.
Abstract: During the past 30 years, meta-analysis has been an indispensable tool for revealing the hidden meaning of our research literatures. The four articles in this special section on meta-analysis illus...
20,272 citations
12,729 citations
01 Jul 2009-Epidemiologia E Psichiatria Sociale-an International Journal for Epidemiology and Psychiatric Sciences
TL;DR: The Consolidated Statement of Reporting Trials (CONSORT) provides readers of RCTs with a list of criteria useful to assess trial validity (for full details visit www.consortstatement.org).
Abstract: Method Fifty-seven parents randomised to I0 weeks ofex~erimental Habilitation programmes for intellectual disability are primitive in developing countries (Heron & Myers, 1983). Resources to develop specialist care are scarce in these nations. One compensatory option for this deficit is to facilitate the primary care-giver to take on the role of therapist (McLoughlin, 1992), because parents are the focus of intervention (Myreddi, 1992). Parental attitude influences the development and training of the developmentally disabled child (Beckett-Edwards, 1994) and is a dynamic adaptational process subject to change (Gallimore et al, 1993). Changes in and control therapy were assessed using parental attitude occur with intervention the Parental Attitude Scale towards the (Bruiner & Beck, 1984; Sameroff & Managementof Intellectual DisabilityThe 1990). Interventions with parents are varpreand post-intervention measurements ied (Girimaii, 19931, including a model were done by a single-blinded rater and with an O ~ ~ O r m n i t y raise questions and discuss problems over a period of time (Stecompared. phens & Wyatt, 1969; Cunningham et al, Results The intervention group had a 1993). This randomised-controlled ma1 evalustatistically significant increase in the ates the efficacy of Interactive Group outcome scores and clinical improvement psychoeducation (IGP) in changing attiin the total parental attitude score, tudes towards children with intellectual orientation towards child-rearing, disability.
4,388 citations
Book•
01 Jan 2001
TL;DR: Without a way of critically appraising the information they receive, clinicians are relatively helpless in deciding what new information to learn and decide how to modify their practice.
Abstract: Medical practice is constantly changing. The rate of change is accelerating, and physicians can be forgiven if they often find it dizzying. How can physicians learn about new information and innovations, and decide how (if at all) they should modify their practice? Possible sources include summaries from the medical literature (review articles, practice guidelines, consensus statements, editorials, and summary articles in "throwaway" journals); consultation with colleagues who have special expertise; lectures; seminars; advertisements in medical journals; conversations with representatives from pharmaceutical companies; and original articles in journals and journal supplements. Each of these sources of information might be valuable, though each is subject to its own particular biases. 1,2 Problems arise when, as is often the case, these sources of information provide different suggestions about patient care. See also p 2093. Without a way of critically appraising the information they receive, clinicians are relatively helpless in deciding what new information
3,305 citations