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Implications of Placebo and Nocebo Effects for Clinical Practice: Expert Consensus.

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.

SUBMITTER: Evers AWM

PROVIDER: S-EPMC6191882 | biostudies-other | 2018

REPOSITORIES: biostudies-other

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Implications of Placebo and Nocebo Effects for Clinical Practice: Expert Consensus.

Evers Andrea W M AWM Colloca Luana L Blease Charlotte C Annoni Marco M Atlas Lauren Y LY Benedetti Fabrizio F Bingel Ulrike U Büchel Christian C Carvalho Claudia C Colagiuri Ben B Crum Alia J AJ Enck Paul P Gaab Jens J Geers Andrew L AL Howick Jeremy J Jensen Karin B KB Kirsch Irving I Meissner Karin K Napadow Vitaly V Peerdeman Kaya J KJ Raz Amir A Rief Winfried W Vase Lene L Wager Tor D TD Wampold Bruce E BE Weimer Katja K Wiech Katja K Kaptchuk Ted J TJ Klinger Regine R Kelley John M JM

Psychotherapy and psychosomatics 20180612 4

<h4>Background</h4>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 me ...[more]

PMID: 29895014

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Project description:IntroductionUnderstanding placebo and nocebo responses (context/meaning effects [CMEs]) is fundamental to physician agency. Specific instruction in CMEs is often lacking in medical education. Patient-practitioner interactions may challenge medical students' understanding of biomedical causality and the nexus between this, practical ethics and professionalism across various conceptual and applied aspects of CMEs. This study compared the corpus of knowledge and phronesis related to CMEs between Australian graduate medical students and rheumatologists to gain a sophisticated understanding of this relationship to inform curriculum development.MethodIn 2013 and 2014, the authors surveyed third-year medical students undertaking a graduate programme in an Australian medical school and Australian rheumatologists to ascertain their understanding of placebo and nocebo responses. The survey ascertained (1) the alignment of the respondents' understanding of CMEs with accepted facts and concepts; (2) opinions on the ethical status of CMEs; and (3) responses to 2 scenarios designed to explore matters of biomedical causality, practical ethics and professionalism.ResultsThere were 88 completed surveys returned, 53 rheumatologists and 35 students. Similar proportions within each group identified CMEs, with most (n = 79/88 [89.8%]) correctly recognising a placebo (rheumatologists: 50 [94.3%], students: 29 [82.9%]) and approximately three-quarters (n = 65/88 [73.9%]) correctly recognising nocebo effects (rheumatologists: 39 [73.6%], students: 26 [74.3%]). Statistically significant differences between practitioners and students were observed in relation to the following: placebo responders and placebo responsiveness; placebos as a 'diagnostic tool'; placebos usage in clinical practice and research, and nocebo effects.ConclusionsPhysicians require an awareness of CMEs and the fact that they arise from and influence the effective agency of health care professionals. Curricular emphasis is needed to permit an honest assessment of the components that influence when, how and why patient outcomes arise, and how one's agency might have neutral or negative effects but could be inclined towards positive and away from negative patient outcomes.

Project description:BackgroundGlucagon-like peptide-1 receptor agonists (GLP-1RAs) are an established treatment for patients with type 2 diabetes (T2D). Differences between GLP-1RAs in pharmacokinetics, dosing regimens and clinical effects, including cardiovascular (CV) outcomes, mean there may be benefits to switching from one to another. However, clinical guidance on switching is lacking and data from clinical trials are limited. This article provides a clinical perspective and consensus on the benefits of switching between GLP-1RAs, the triggers for switching and how best to manage this in clinical practice. Once weekly (OW) semaglutide is used as an example to illustrate how the authors might switch to a different GLP-1RA in clinical practice.MethodsLiterature was searched and perspectives from 10 healthcare professionals with experience in switching patients with T2D to OW semaglutide from another GLP-1RA were collated.ResultsMedical triggers for switching to another GLP-1RA included HbA1c targets not being met, a desire for additional weight loss, poor adherence, patients moving to increased CV risk status and adverse effects with the current GLP-1RA. Non-medical triggers for switching included patient preference, cost, formulary changes and insurance mandates. Once the decision to switch is made, an individualised approach is recommended, based on considerations that include reimbursement requirements, treatment duration with (and dose of) previous GLP-1RA, the patient's experience initiating the prior GLP-1RA, any concomitant treatment and clinical characteristics. When switching, it is important to emphasise that treatment burden will not increase and that if gastrointestinal adverse effects occur, they are typically transient. Any transient gastrointestinal adverse effects that may occur (or recur) when switching to another GLP-1RA can be reduced by slow up-titration and advising patients to reduce food portion sizes and fat intake.ConclusionSwitching from one GLP-1RA to another, such as OW semaglutide, can provide clinical benefits and may delay the need for treatment intensification.

Project description:Introduction: Placebo and nocebo effects are positive and negative health outcomes that can be elicited by the psychosocial context. They can be mediated by expectations, and may emerge in somatic symptoms even when people are aware of these effects. Interindividual differences (e.g., in personality, affective states) could impact placebo and nocebo responding, but findings are inconsistent. Methods: The current work examined expectation as a mediator of the association between verbal placebo and nocebo suggestions (VSs) and histamine-induced itch across three experimental studies. Moreover, we examined whether interindividual differences (e.g., in optimism, neuroticism, behavioral activation system (BAS), body ignorance) modulated: (1) the direct association between VSs and itch (direct moderation), and (2) the indirect, expectation-mediated association between VSs and itch (moderated mediation). Positive VSs were compared to neutral instructions (Study 1; n = 92) or negative VSs (Studies 2+3; n = 203) in an open-label (i.e., explaining placebo and nocebo effects) or closed-label (concealed) context using PROCESS. First, mediation of VSs effects on itch by expectations was tested. Next, moderation by individual traits was explored using conditional process analyses. Results: The effects of VSs on itch were significantly mediated by expectation in Study 1 and in the open-label (but not closed-label) contexts of Studies 2 and 3. Ignorance of bodily signals marginally moderated the direct effects of VSs on itch when closed-label suggestions were given: at low levels of body ignorance, effects of positive and negative VSs were stronger. Moreover, moderated mediation was observed in the open-label groups of Studies 2 and 3: The expectation-mediated effects of VSs on itch were stronger when BAS drive was lower. Conclusion: Overall, the effects of VSs on itch were mediated by expectations in the open-label, but not the closed-label context. Moreover, the current work suggests that placebo and nocebo effects may be moderated by ignorance of bodily signals and the BAS. There was limited evidence that other interindividual differences modulated placebo and nocebo responding in itch.

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Implications of Placebo and Nocebo Effects for Clinical Practice: Expert Consensus.

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Implications of Placebo and Nocebo Effects for Clinical Practice: Expert Consensus.

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