Placebo Effects: Understanding the mechanisms in health and disease

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Corresponding Author Andrea W. 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 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. Placebo and nocebo research has now evolved from a methodological consideration within clinical research to a distinct and expanding interdisciplinary field in its own right. Placebo studies encompass a broad variety of disciplines from biomedicine and neuroscience to the social and behavioural sciences and the humanities [ 1 - 14 ].

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Placebo and nocebo effects refer to the beneficial or adverse effects that occur in clinical or laboratory medical contexts, respectively, after administration of an inert treatment or as part of active treatments, due to mechanisms such as expectancies of the patient. Current research incorporates both the study of placebo and nocebo responses as an outcome in clinical trials as well as the study of placebo and nocebo effects and their psychological and neurobiological mechanisms in various clinical applications, including many medical disciplines.

Current objectives in the field are to produce cross-disciplinary conceptualizations of placebo and nocebo effects; to re-evaluate the ethics of placebos in clinical trials and practice; and to initiate the ethical translation of empirical findings into clinical practice. Robust empirical evidence now demonstrates that placebo and nocebo effects are both significant and measurable for many conditions e. | Placebo Effects: Understanding the mechanisms in health and disease (ebook), Fabrizio

Importantly, placebo and nocebo effects can substantially modulate the efficacy and tolerability of active pharmacological or other medical treatments [ 15 , 16 ]. This empirical evidence from experimental and clinical studies challenges health-care professionals to translate and implement the findings of placebo and nocebo research into practice. This translation relates not only to the possible use of placebos as part of regular treatments e.

Due to the interdisciplinary nature of this emerging field with its potentially wide applications across health care, there is a need to develop and formalize guidelines on the available evidence, including the possible implications of placebo and nocebo effects for clinical practice [ 17 ]. Notwithstanding the content of ethical guidelines and codes, studies reveal that the use of both pure e.

Until now, however, there has been no study of expert opinions in placebo and nocebo studies about the implications of this research for clinical practice. The aim of this survey and meeting was to develop a consensus on clinical recommendations based on the current state of the art in placebo and nocebo research among experts in the field. Of the 31 invited speakers at the 1st official Society for Interdisciplinary Placebo Studies SIPS conference, 29 agreed to take part; the 2 who chose not to participate indicated that their research was not clinically focused.

The 29 invited experts completed the survey, of whom 4 invited speakers were unavailable to participate due to personal circumstances. A workgroup of 6 members A. The 29 participants were from 12 different countries, had an average age of In total, The participants had on average Based on a literature review of the relevant empirical evidence on possible clinical applications of placebo and nocebo effects, a survey was developed that focused on 4 themes: a prescription of placebo as regular treatment; b open-label prescription of placebo; c nocebo effects, and d patient-clinician communication.

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Subsequently, items for each theme were developed and checked by all members of the workgroup for relevance, readability and clarity. This process yielded 40 items in all, 10 for each theme. Appendix Table S1 for a complete overview of the survey; for all online suppl. Material, see www. The survey was analysed by calculating the mean score for each item. Items that resulted in more mixed levels of agreement scores between 2 and 8 were not discussed at the clinical expert meeting.

The clinical experts met in a 1-day pre-conference session in Leiden, The Netherlands, on April 2, At this meeting, the results of the survey and possible recommendations and discussion points were explored in plenary sessions. Consensus was reached based upon results of the survey and the discussion during the meeting. The meeting was audio-recorded and minutes were taken.

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In the sections below, we describe the main results of the survey and expert meeting. The initial discussion centred on defining important components of the placebo concept. We then summarize the survey statements with high agreement, as well as the related evidence, together with relevant comments discussed at the clinical expert meeting. A summary of the recommendations is listed in Table 1. The experts agreed that it is crucial to distinguish between placebo and nocebo responses versus placebo and nocebo effects.

In line with the drug terminology proposed by Fisher et al. The placebo and nocebo effect refers to the changes specifically attributable to placebo and nocebo mechanisms, including the neurobiological and psychological mechanisms of expectancies. These mechanisms are shaped, for example, by verbal instruction, or nonverbal or situational cues that affect treatment expectancies see communication by the SIPS community, July 29, [see also 24 ].

Importantly, placebos and nocebos not only have effects during the prescription of placebo pills, but they can also substantially modulate the efficacy and tolerability of active pharmacological or other medical treatments. There was strong consensus that recommendations should be based on the research evidence on placebo and nocebo effects, including the involved mechanisms e. There was a consensus regarding the importance of making optimal use of placebo effects to achieve better treatment outcomes A1 and of optimally informing patients about placebo effects A8 , for example, to explain that a patient might improve due to factors other than the treatment itself, such as expectancies regarding treatment prognosis.

However, the experts also acknowledged the current lack of knowledge about how best to provide this information to patients to ensure that patients are optimally informed. For example, there is insufficient knowledge about the ways in which patients and health-care providers can maximize placebo effects and minimize nocebo effects over time during repeated interactions and treatments [ 25 ]. The experts strongly agreed that clinicians should not prescribe or practice more invasive treatments simply to engender more potent placebo effects A7.

Although some systematic reviews have found that more intensive and invasive treatments can augment placebo effects, results are not consistent and are often moderated by factors such as the symptom or condition treated or the specific procedures used [ 26 ]. Moreover, there are clear practical and ethical restrictions on prescribing more invasive treatments for the sake of producing stronger placebo effects, since these procedures are often more expensive and entail a higher risk of undesirable side effects.

Consequently, the experts agreed that prescription of more intensive and invasive treatment e. Where open-label placebo i. Importantly, there are compelling ethical arguments for informing patients about placebo treatments in clinical contexts [ 27 ]. Related to these findings, the majority of the experts strongly agreed that deception is not necessary for placebo effects to occur B2. This viewpoint is empirically supported by recent studies in patients with irritable bowel syndrome and chronic pain, which showed beneficial effects of open-label placebo on primary symptom outcomes, such as pain or disability [ 28 - 31 ].

However, more research is needed in other conditions and patient groups before recommendations can be developed about their possible use in clinical practice. For example, non-significant findings were found in a pilot study in patients with a major depressive disorder in a small sample of 12 patients, although the medium effect size was comparable to the other trials [ 32 - 34 ]. It has to be established whether specific patient groups or subgroups of patients benefit more than others from open-label placebos, or whether biological or psychological markers are associated with the effectiveness of these open-label placebo strategies.

Promising is the case of dose-extending placebos e.

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Although prescription of placebos is not yet regulated in any part of the world and additional research is necessary on its short- and long-term effects, open-label prescription of placebos could be considered as a possible future watch and wait strategy or for use in long-term conditions when other treatment options have failed [ 33 ]. There was a consensus regarding strategies to minimize and prevent nocebo effects.

Experts agreed that nocebo effects should be explained to patients C1 and that information about side effects should be presented in such a way that nocebo effects are minimized C4. The relatively strong consensus regarding optimally informing patients to minimize nocebo effects might be due to its high clinical relevance, which is based on findings that nocebo effects have been shown to consistently worsen treatment outcomes and to be at least in part responsible for side effects [ 6 , 10 - 12 , 35 ].

Indeed, there is convincing evidence that the way in which patients are informed about risks and side effects influences the likelihood of their occurrence. Fabrizio Benedetti. The placebo effect is one of the most widely used and familiar terms within science and medicine, yet it is not always clear just what we mean by a placebo effect. Though we might describe a placebo effect as being 'all in the mind', we now know that there is a genuine neurobiological basis to this phenomenon.

In recent years our knowledge of the neural bases of the placebo effect has developed markedly, and we now have a far better understanding of how it can influence both the course of a disease and the response to therapy.

This is the first book to critically review the mechanisms of placebo and placebo-related effects across all medical conditions, diseases, and therapeutic interventions.