Williams argues that humans have evolved special purpose adaptations for eliciting medical attention from others, such as a specific facial expression of pain. She also recognises that such adaptations would almost certainly have coevolved with adaptations for providing and responding to medical care. The placebo response may be one such adaptation, and any evolutionary account of pain must also address this important phenomenon.

Is there a response, which is not accounted for by regression to the mean, natural history, the Hawthorne effect?The term placebo comes to us from the Latin for "I shall please," indicating that the phenomenon known as the "placebo effect" or "placebo response" has been familiar to medical practitioners for a number of centuries, at least. As we reached the mid-20th century and randomized controlled trials became a central feature of medical research, the use of (...) controls and blinding in those trials allowed for the isolation of the placebo effect in ways that made it much clearer that there... (shrink)

The concepts of placebos and placebo effects refer to extremely diverse phenomena. I recommend dissolving the concepts of placebos and placebo effects into loosely related groups of specific mechanisms, including (potentially among others) expectation-fulfillment, classical conditioning, and attentional-somatic feedback loops. If this approach is on the right track, it has three main implications for the ethics of informed consent. First, because of the expectation-fulfillment mechanism, the process of informing cannot be considered independently from the potential effects of treatment. (...) Obtaining informed consent influences the effects of treatment. This provides support for the authorized concealment and authorized deception paradigms, and perhaps even for outright deceptive placebo use. Second, doctors may easily fail to consider the potential benefits of conditioning, leading them to misjudge the trade-off between beneficence and autonomy. Third, how attentional-somatic feedback loops play out depends not only on the content of the informing process but also on its framing. This suggests a role for libertarian paternalism in clinical practice. (shrink)

It has been presumed within bioethics that the benefits and risks of treatments can be assessed independently of information disclosure to patients as part of the informed consent process. Research on placebo and nocebo effects indicates that this is not true for symptomatic treatments. The benefits and risks that patients experience from symptomatic treatments can be shaped powerfully by information about these treatments provided by clinicians. In this paper we discuss the implications of placebo and nocebo research for (...) risk–benefit assessment and informed consent. (shrink)

Often regarded simply as a nuisance in clinical drug trials in which the aim is to separate drug response from placebo response in a statistically significant manner, the placebo response has important implications. These implications relate to the nature of illness, the study of non-specific factors in the treatment setting that are related to clinical improvement, methods of enhancing these non-specific sources of benefit, and the neurobiology that is associated with the placebo response. (...) Specific sources of clinical improvement in medical and psychological treatment generally consist of drugs or clear interventions that appear to directly contribute to the desired treatment. Non-specific factors, on the other hand, include the clinician–patient relationship, installation of hope, relationship with authority, and other such factors that are more implicit to treatment and may contribute to the placebo response. Our understanding of how these non-specific aspects of treatment relate to clinical improvement and ways of enhancing these non-pharmacological elements of therapy may form important aspects of treatment. Furthermore, an important, albeit potentially overlooked element of the placebo response are clinical-trial designs and methodologies, themselves. Specific neurobiological changes also appear to be associated with the placebo response in at least some cases. Finally, it is suggested that the placebo response may in some instances represent a type of brain plasticity in which expectation and desire — agency — can result in specific changes in brain function that either may mirror or differ from the effects of certain drugs. (shrink)

The placebo effect is a common phenomenon in therapy and research but has received very little attention as such in nursing research. This article reviews some of the literature which shows the placebo effect, which can be positive or negative, is a significant force. Then it is argued that, while all health professionals have a general obligation to benefit their patients, nursing has a special, specific obligation to enhance the placebo effect, to maximize a positive effect and (...) minimize a negative effect. Nursing education, current policy statements, and circumstances of clinical practice explain this obligation. Nursing research is needed to clarify the multiple ways in which the social and physical environment can trigger a placebo effect. As nursing expands its knowledge of this effect, it can begin to educate patients to the self-care implications of this pervasive but misunderstood phenomenon. Keywords: ethics, placebo, placebo effect, self care CiteULike Connotea Del.icio.us What's this? (shrink)

POHLMAN S, CIBULKA NJ, PALMER JL, LORENZ RA and SMITHBATTLE L. Nursing Inquiry 2013; 20: 71–81 The placebo puzzle: examining the discordant space between biomedical science and illness/healingThe placebo response presents an enigma to biomedical science: how can ‘inert’ or ‘sham’ procedures reduce symptoms and produce physiological changes that are comparable to prescribed treatments? In this study, we examine this puzzle by explicating the discordant space between the prevailing biomedical paradigm, which focuses on a technical understanding of (...) diagnosis and treatment, and a broader understanding of illness and healing as relational and embodied. Although biomedical achievements are impressive, the knowledge resulting from this paradigm is limited by its ontological and epistemological assumptions. When the body and world are objectified, illness meanings, therapeutic relationships, and healing practices are dismissed or distorted. In spite of a robust critique of the tenets of biomedicine for guiding practice, the biomedical paradigm retains a tenacious hold on evidence-based medicine and nursing, downplaying our clinical understanding of the sentient body, patients’ life-worlds, and illness and healing. In reality, skilled nurses rely on multiple forms of knowledge in providing high-quality care to particular patients. Clinically wise nurses integrate their experience and knowledge of patients’ priorities, fears, and illness trajectories along with biomedical findings to make astute judgments and promote health and healing. (shrink)

Grunbaum claims that the remedial failure of atreatment's characteristic factors is thegeneric, objective property of a placebo. Hestipulates that a treatment is placebic if thisremedial failure exacerbates the targetdisorder. This stipulation can subsume asplacebic effects that might be solelypharmacological, e.g., paradoxical reactions tocertain psychiatric drugs. If that exacerbationcan be explained pharmacologically, then wemight question whether Grunbaum's definitionalscheme captures the core identity of what weusually intend by the placebo concept. Ipropose that this core identity is bestcaptured by a symbolic (...) meaning hypothesis inwhich psychological factors exert thedeterminative influence. (shrink)

Abstract. The placebo effect these days is no longer merely the insubstantial, subjective response that some patients have to a sham treatment, like a sugar pill. It has been reconceived as a powerful mind-body phenomenon. Because of this, it has also emerged as a complex reference point in a number of high-stakes conversations about the metaphysical significance of experiences of religious healing, the possible health benefits of being religious, and the feasibility of using double-blind placebo-controlled trials to (...) investigate the efficacy of prayer. In each of these conversations, the placebo effect is always pointing toward some larger issue, serving some larger agenda. The agendas, though, tend to pull in different directions, leading to a situation that feels at once fractured and stalemated. This essay reviews the main areas of interest, and proposes some specific issues where humanistic scholars of religion in particular might be able to introduce constructive and creative new perspectives. (shrink)

ABSTRACT:The objective of this essay is to develop the argument that placebos are a species of metaphor and to demonstrate that an analysis of the figurative trope can help us elucidate the power of the placebo response. The cognitive and embodied responses to both metaphors and placebos stem from the transfer of meaning between two domains, each with rich allusive properties that in turn depend on highly ramified and interconnected neural webs. Metaphors and placebos require an appropriate cultural (...) backdrop for their linguistic and cognitive work and are dependent on shared social forms of life. More specifically, metaphors rely on an intersubjective connection and imply that a relational entanglement between doctor and patient is necessary to the effect of placebos in the clinical setting. (shrink)

Evidence that placebo acupuncture is an effective treatment for chronic pain presents a puzzle: how do placebo needles appearing to patients to penetrate the body, but instead sitting on the skin’s surface in the manner of a tactile stimulus, evoke a healing response? Previous accounts of ritual touch healing in which patients often described enhanced touch sensations suggest an embodied healing mechanism. In this qualitative study, we asked a subset of patients in a singleblind randomized trial in (...) irritable bowel syndrome to describe their treatment experiences while undergoing placebo treament. Analysis focused on patients’ unprompted descriptions of any enhanced touch sensations and any significance patients assigned to the sensations. We found in 5/6 cases, patients associated sensations including “warmth” and “tingling” with treatment efficacy. The conclusion offers a “neurophenomenological” account of the placebo effect by considering dynamic effects of attentional filtering on early sensory cortices, possibly underlying the phenomenology of placebo acupuncture. (shrink)

A great variety of medical conditions are subject to the placebo effect. Although there is mounting evidence to suggest that the placebo effect is related to the expectation of clinical benefit, little is still known about the biochemical bases underlying placebo responses. Positron emission tomography studies have recently shown that the placebo effect in Parkinson’s disease, pain, and depression is related to the activation of the limbic circuitry. The observation that placebo administration induces the release (...) of dopamine in the ventral striatum of patients with Parkinson’s disease suggests a link between the placebo effect and reward mechanisms. In addition to Parkinson’s disease, the placebo-reward model may also apply to other disorders. However, the relative contribution of the different neurotransmitters and neuropeptides that are known to be involved in modulating the activity of the limbic system may be disease-specific. Thus, while the placebo-induced clinical benefit observed in Parkinson’s disease would mostly reflect the release of dopamine in the dorsal striatum, the activation of opioid and serotonin pathways could be particularly implicated in mediating placebo responses encountered in pain and depression, respectively. (shrink)

Physicians commonly recommend ?placebo treatments?, which are not believed to have specific efficacy for the patient's condition. Motivations for placebo treatments include complying with patient expectations and promoting a placebo effect. In this article, we focus on two key empirical questions that must be addressed in order to assess the ethical legitimacy of placebo treatments in clinical practice: 1) do placebo treatments have the potential to produce clinically significant benefit? and 2) can placebo treatments (...) be effective in promoting a therapeutic placebo response without the use of deception? We examine evidence from clinical trials and laboratory experiments bearing on these two questions. The conclusion is reached that based on currently available evidence, it is premature to judge whether placebo treatments are ethically justifiable, with the possible exception of acupuncture for pain relief. (shrink)

The use of statistics in medical research has been compared to a religion: it has its high priests, supplicants, and orthodoxy. Although the comparison may be more unfair to religion than to research, a useful lesson can nonetheless be drawn: the practice of clinical research may benefit—as does the spirit—from critical self-examination. Arguably, no aspect of the conduct of clinical trials is currently more controversial—and thus in as dire need of critical examination—than the use of placebo controls. The ethical (...) and scientific controversies associated with placebo-controlled trials, never far below the surface, have once again seized public attention. Clearly, concern about these issues within the professional community runs deep and wide, as evidenced by the volume of response generated by Kenneth Rothman and Karin Michels's recent Critique. Criticisms of the use of placebo controls in clinical research are scattered through the literatureo; our objective is to present the case against placebos in a compendious form that takes account of scientific and statistical as well as normative issues. (shrink)

The use of statistics in medical research has been compared to a religion: it has its high priests, supplicants, and orthodoxy. Although the comparison may be more unfair to religion than to research, a useful lesson can nonetheless be drawn: the practice of clinical research may benefit—as does the spirit—from critical self-examination. Arguably, no aspect of the conduct of clinical trials is currently more controversial—and thus in as dire need of critical examination—than the use of placebo controls. The ethical (...) and scientific controversies associated with placebo-controlled trials, never far below the surface, have once again seized public attention. Clearly, concern about these issues within the professional community runs deep and wide, as evidenced by the volume of response generated by Kenneth Rothman and Karin Michels's recent Critique. Criticisms of the use of placebo controls in clinical research are scattered through the literatureo; our objective is to present the case against placebos in a compendious form that takes account of scientific and statistical as well as normative issues. (shrink)

The material presented at this conference pointed to a new dimension in the prosecution of activities that seek to relieve people of disease. While the simple instrument of the placebo may show those interested in the efficacy of physiologically active chemicals the extent to which the chemical of interest is actually active, the surprising outcome of such studies is that the placebo per se is worthy of more general study. This, when taken further, points to the ways in (...) which mind can influence the matter of the body. Of course, mind itself is an activity of matter, so we may retain the experimental approach that has told us about the world outside ourselves to examine the world that is inside our brains. New techniques and approaches to these once intractable problems are now in train. Where they will lead us we cannot predict, but as with the emergence of all new tools, we have to adopt those ethics that will carry us forward with the expectation that we will maximise benefits and minimise harms. (shrink)

One of the most successful physicians I have ever known, has assured me, that he used more bread pills, drops of colored water, and powders of hickory ashes, than of all other medicines put together. It was certainly a pious fraud.Clinicians and other health-care practitioners have known for hundreds of years that different procedures with unclear mechanisms of action or efficaciousness can still result in subjective improvement of clinical symptoms. Many scholars have attempted to define the placebo effect. This (...) has resulted in the development of multiple frameworks and models that help explain and further explore placebo effects and responses. After providing some definitions and clarifications of terminology... (shrink)

Riassunto : L’ effetto nocebo è l’effetto psicobiologico dovuto al contesto psicosociale negativo che accompagna una terapia. Dal momento che lo studio dell’ anticipazione dolorifica prende in considerazione la fase temporale della “attesa dell’iperalgesia”, e considerando che – proprio come il nocebo – è possibile elicitarla con il solo uso di verbalizzazioni negative, questo modello può permettere di studiare la risposta nocebo. Ad oggi infatti non si dispone di dati univoci circa le aree coinvolte in questi processi e circa il (...) ruolo cognitivo da queste ricoperto. Abbiamo condotto una meta-analisi su studi fMRI di anticipazione dolorifica su cui applicare un modello di connettività meta-analitica su due regioni di interesse: la corteccia cingolata e l’insula anteriori, le cui attivazioni sembrerebbero correlano ai domini comportamentali dell’azione, dell’emozione e della percezione. I risultati avvalorano l’ipotesi dell’esistenza di un sistema supramodale altamente distribuito, attivato dall’anticipazione del dolore, e, infine, volto all’elaborazione delle informazioni e all’auto-regolazione delle risposte adattive all’ambiente. Parole chiave : Placebo; Nocebo; Dolore; Correlati neurali; Comportamento umano Placebo Analgesia, Pain Anticipation, and the Possible Neural Correlates of Nocebo Effect: The nocebo effect is a psychobiological effect that occurs when a negative psychosocial context that accompanies a therapy. Since the study of pain anticipation takes into account the temporal phase of the “expectation of hyperalgesia”, and considering that it is possible to stimulate such anticipatory processes merely through the use of negative verbalizations, this model is appropriate for studying the nocebo response. To date, there are no univocal data about the brain areas involved in these processes or their cognitive roles. We conducted a meta-analysis on pain anticipation fMRI studies. We then applied a meta-analytic connectivity model to activations in the anterior cingulate cortex and the anterior insula, which correlate with the behavioral domains of action, emotion and perception. Our results support the hypothesis that there is a highly-distributed supramodal system, activated by pain anticipation, for processing information that enhances the self-regulation of adaptive responses to the environment. Keywords : Placebo; Nocebo; Pain; Neural Correlates; Human Behaviour. (shrink)

We review three possible theoretical mechanisms for the placebo effect: conditioning, expectancy and endogenous opiates and consider the implications of the first two for clinical research and practice in the area of pain management. Methodological issues in the use of placebos as controls are discussed and include subtractive versus additive expectancy effects, no treatment controls, active placebo controls, the balanced placebo design, between- versus within-group designs, triple blind methodology and the double expectancy design. Therapeutically, the possibility of (...) shaping negative placebo responses through placebo sag, overservicing and the use of placebos on their own are explored. Suggestions for using conditioned placebos strategically in conjunction with nonplacebos are made and ways of maximizing the placebo component of nonplacebo treatments are examined. Finally, the importance of investigating the placebo effect in its own right is advocated in order to better understand the long-neglected psychological aspects of the therapeutic transaction. (shrink)

Most mainstream attempts to understand the “placebo effect” invoke expectancy theory, arguing that expecting certain outcomes from a treatment or intervention can manifest those outcomes. Expectancy theory is incompatible with the phenomena of placebo responses, more appropriately named “meaning responses.” The expectancy account utilizes reflexive consciousness to connect a world of conceptual representations to mechanical physiology. An alternative account based upon Merleau-Ponty's motor intentionality argues that the body understands and is capable of responding to meanings without the need (...) for any conceptual or linguistic content. A motor intentional framework of meaning poses dramatic implications for the interpretation of clinical trials and in the clinical practice of medicine. Most strongly, it argues that the empathic physician can facilitate the physiologic effects of treatments through skillful participation and manipulation of the meaning response. (shrink)

A great variety of medical conditions are subject to the placebo effect. Although there is mounting evidence to suggest that the placebo effect is related to the expectation of clinical benefit, little is still known about the biochemical bases underlying placebo responses. Positron emission tomography studies have recently shown that the placebo effect in Parkinson’s disease, pain, and depression is related to the activation of the limbic circuitry. The observation that placebo administration induces the release (...) of dopamine in the ventral striatum of patients with Parkinson’s disease suggests a link between the placebo effect and reward mechanisms. In addition to Parkinson’s disease, the placebo-reward model may also apply to other disorders. However, the relative contribution of the different neurotransmitters and neuropeptides that are known to be involved in modulating the activity of the limbic system may be disease-specific. Thus, while the placebo-induced clinical benefit observed in Parkinson’s disease would mostly reflect the release of dopamine in the dorsal striatum, the activation of opioid and serotonin pathways could be particularly implicated in mediating placebo responses encountered in pain and depression, respectively. (shrink)

National and international research cultures for the innovation of new medicines involve various value claims about the ethics of the placebo entity as differentiating comparator. Yet, in turn, the instantiation of the placebo comparator as cultural artefact for the creation and identification of the ‘control group’ depends also upon prior social understandings of ‘comparability’. Reading back the ethics controversies surrounding the Risperidone psychiatry trials in India, the paper illustrates why drug efficacies need to be studied not only through (...) comparative techniques such as randomised controlled trials, but also through analytical modes of inquiry that can begin to place the problem of efficacy within particular social and cultural contexts, as well as across disciplines. It is suggested that future bioethics debates could benefit from a revised conception of the interdisciplinary placebo — one that is rooted in ‘placebo politics’ and that listens responsively to the voices of the global South. (shrink)

Among medical researchers and clinicians the dominant view is that it is unethical to deceive patients by prescribing a placebo. This opinion is formalized in a recent policy issued by the American Medical Association (AMA [Chicago, IL]). Although placebos can be shown to be always safe, often effective, and sometimes necessary, doctors are now effectively prohibited from using them in clinical practice. I argue that the deceptive administration of placebos is not subject to the same moral objections that face (...) other forms of deception in clinical practice and medical research. Although deception is normally objectionable on the grounds that it limits autonomy and breaches trust, these grounds do not apply to placebos when they are prescribed within appropriate ethical limits. Patients have reason to prefer that doctors can prescribe placebos in ethically responsible ways. Hence, the AMA has an obligation to endorse and to promote the responsible use of deceptive placebos in clinical practice. (shrink)

The placebo effect is now generally defined widely as an individual’s response to the psychosocial context of a clinical treatment, as distinct from the treatment’s characteristic physiological effects. Some researchers, however, argue that such a wide definition leads to confusion and misleading implications. In response, they propose a narrow definition restricted to the therapeutic effects of deliberate placebo treatments. Within the framework of modern medicine, such a scope currently leaves one viable placebo treatment paradigm: the (...) non-deceptive and non-concealed administration of “placebo pills” or open-label placebo (OLP) treatment. In this paper, I consider how the placebo effect occurs in OLP. I argue that a traditional, belief-based account of OLP is paradoxical. Instead, I propose an account based on the non-doxastic attitude of pretence, understood within a fictionalist framework. (shrink)

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. Then, a (moderately) emergentist approach (...) to nursing knowledge is proposed, based on the assumption of a two‐way flow from the general to the particular and vice versa. The case of the ‘placebo effect’ is analysed as an example of emergentist knowledge. The placebo effect is usually considered difficult to be explained within the classical biomedical model, and we underscore its importance in shaping nursing knowledge. In fact, nurses are primarily responsible for administering placebo in the clinical setting and have an essential role in promoting the placebo effect and reducing the nocebo effect. The beliefs responsible for the placebo effect are as follows: (1) interactive, because they depend on the relationship between patients and health care professionals; (2) situated, because they occur in a given clinical context related to certain rituals; and (3) grounded on higher order beliefs concerning what an individual thinks about the beliefs of others. It is essential to know the clinical context and to understand other people's beliefs to make sense of the placebo effect. The placebo effect only works when the (higher order) beliefs of doctors, nurses and patients interact in a given setting. Finally, we argue for a close relationship between placebo effect and nursing knowledge. (shrink)

Over 200 years ago, doctors' most effective tools were typically not found in their medical bags. Indeed, most treatments in the history of medicine have, until relatively recently, caused more harm than good. Prior to the biomedical revolution in the late 19th century, doctors' most reliable and effective instruments of healing were their skills of communication with patients and an aptitude for a positive and supportive bedside manner. Bearing out this portrait of medicine, Thomas Jefferson, writing in 1807, noted that (...) "one of the most successful physicians I have ever known has assured me that he used more bread pills, drops of colored water, and powers of hickory ashes, than of all other medicines put together"... (shrink)

Randomised placebo-controlled trials (RPCTs) are the gold standard for evaluating novel treatments. However, this design is rarely used in the context of orthopaedic interventions where participants are assigned to a real or placebo surgery. The present study examines attitudes towards RPCTs for orthopaedic surgery among 687 orthopaedic surgeons across the USA. When presented with a vignette describing an RPCT for orthopaedic surgery, 52.3% of participants viewed it as ‘completely’ or ‘mostly’ unethical. Participants were also asked to rank-order the (...) value of five different types of evidence supporting the efficacy of a surgery, ranging from RPCT to an anecdotal report. Responses regarding RPCTs were polarised with 26.4% viewing it as the least valuable (even less valuable than an anecdote) and 35.7.% viewing it as the most valuable. Where equipoise exists, if we want to subject orthopaedic surgeries to the highest standard of evidence (RPCTs) before they are implemented in clinical practice, it will be necessary to educate physicians on the value and ethics of placebo surgery control conditions. Otherwise, invasive procedures may be performed without any benefits beyond possible placebo effects. (shrink)

Physical environmental factors – or ‘artifacts’ – are linked to healthcare outcomes in the field of social psychology. However, the role of artifacts remains rarely examined in the burgeoning discipline of placebo studies. In this paper, we argue that a careful consideration of artifacts – such as provider clothing and office décor – may carry significant potential in eliciting placebo effects in clinical settings. We discuss three potential mechanisms by which artifacts may enhance or diminish placebo (or (...) nocebo) effects: classical conditioning, response expectancy, and mindsets. We propose testable hypotheses and conclude by providing innovative research designs that might help to better advance this novel research agendum. (shrink)

In the field of placebo studies residual disagreement about the terminology ‘placebo’ and ‘placebo effect’ still persists. We differentiate between the conceptualization of placebos in clinical trials; and placebo effects understood as a psychobiological phenomenon. With respect to the latter, we argue that a scientific ‘placebo paradigm’ has emerged, indicating that—at least among placebo scientists—there exists relatively stable consensus about how to conceive of placebo effects. We claim that existence of a placebo (...) paradigm does not protect concepts from revision; nonetheless, we argue that scientific progress is dependent on, and guided by relative conceptual stability. Therefore, to mount persuasive arguments for conceptual revision in respect of ‘placebo effects’ we argue, critics either need to defend the claim that a placebo paradigm is not underway, or that there are major scientific failings in respect of it. With these considerations in mind we examine three alternative proposals for conceptual reform: Grünbaum/Howick’s relativity models of placebo concepts; Moerman/Brody’s meaning response; and Nunn/Turner’s proposal for conceptual eliminativism. We derive two conclusions from this evaluation. First, we conclude that no convincing arguments have so far been presented for conceptual overhaul of ‘placebo effects.’ Notwithstanding this analysis, we conclude that refinement of this concept is likely. Second, we agree with Turner and Nunn that the term ‘placebo’ in the context of randomized controlled trials remains a source of confusion for many researchers, risking the design and scientific integrity of clinical findings. Therefore, in these contexts, replacing the term ‘placebo’ with ‘control’ is justified. (shrink)

Even though there are several studies showing a clear connection between religious coping and distress, only few of them illustrate models of mediation between religious coping and its psychological effects. In this paper we investigate the mediation effect that response expectancies have in the relation between religious coping and non-volitional responses . The study was made on 38 females diagnosed with breast cancer and which were following a treatment with radiotherapy sessions. The results confirmed the presence of a mediation (...) effect in the case of negative religious coping. When the mediator was present we registered significant indirect effects ranging from 37% to 47% of the Total effect that negative religious coping had on its outcomes. Our results suggested that religious coping could act like a placebo, the appearance of its effects being mediated by response expectancies. Due to its significant prediction effect upon non-volitional responses, we propose the introduction of the concept of religious response expectancies. (shrink)

Since its introduction in 1964, the World Medical Association’s Declaration of Helsinki—Ethical Principles for Medical Research Involving Human Subjects has enshrined the importance of safeguarding the well-being of human subjects in clinical research. The Declaration has undergone seven revisions, often in response to requests for clarification. I want to argue that the Declaration is in need of another revision in light of recent discoveries in placebo research.

Symbolic healing, that is, responding to meaningful experiences in positive ways, can facilitate human healing. This process partly engages consciousness and partly evades consciousness completely (sometimes it partakes of both simultaneously). This paper, presented as the Society for the Anthropology of Consciousness Distinguished Lecture at the 2011 AAA meeting in Montreal, reviews recent research on what is ordinarily (and unfortunately) called the “placebo effect.” The author makes the argument that language use should change, and the relevant portions of what (...) is often called the placebo effect should be referred to as the “meaning response.”. (shrink)

Assessment of risk is one of the key issues in the field of responsible conduct of research which covers discourses of research ethics and research integrity. The principle of minimizing risks and balancing of risks and benefits is one of the main requirements of research ethics. In addition, the content of informed consent that is another fundamental principle of research ethics derives from the assessment of risks and benefits related to a particular research project. Risk assessment also plays a crucial (...) role in methodological design of the research project. This is an important point where research ethics and research integrity discourses overlap. Firstly, because the choice of a control group (e.g., placebo control) is a key ethical issue related to the protection of the research subjects’ interests. Secondly, because the quality of the research data, that is one of the key elements of research integrity, is closely connected to the choice of research methodology as well. The problem of biased interpretation or manipulation of risk related features of biomedical research should also be taken into account. Despite the importance of the concept of risk to the field of biomedical research, its relevance has not yet attracted a sufficient attention in the responsible conduct of research debate. (shrink)

I thank Julie Hersh for her thoughtful and valuable comments on the use of electroconvulsive therapy .1 Discussions with those who have experience of treatments is of the utmost importance when debating issues such as informed consent. I am therefore very pleased to be given this opportunity to respond. Hersh offers three main criticisms of my paper but I hope to show that the tenets of the paper are not undermined by her commentary.Hersh's first criticism stems from her personal experience: (...) she claims that, ‘The results of ECT for me were miraculous’. She argues that ECT ‘works’ and we have ‘70 years of remarkably positive experience’ to support this fact. In response, I agree that there are certainly patients who believe that ECT has been a highly effective intervention: but equally, there are others who have experienced intolerable side effects as a result.2 ECT is a controversial treatment precisely because of the serious long-term risk of memory loss.3 ,4 If we are to strive for the best healthcare possible, we cannot base our conclusions merely on positive cases: we need to consider all cases . Thus, I reject her conclusion that ECT is ‘remarkably positive’ for all patients: studies do not unequivocally support Hersh's fortunate experiences. In addition, I must also challenge the assumption that ECT ‘works’. Counterintuitive as …. (shrink)

Pediatric psychopharmacology is a relatively new science. Although the use of psychotropic medications in children has risen in the past decade, there are few standard treatments for serious psychiatric or developmental disorders of childhood. The relative absence of standard treatments is further complicated by the fact that many of the agents used in pediatric psychopharmacology have been adapted from other fields. Therefore, investigators have a responsibility to make incremental progress from concept through pilot studies and large-scale, multisite efficacy and safety (...) trials. Thus, although there is a pressing need to conduct medication trials that can guide clinical practice, there are scientific and ethical considerations to bear in mind when designing clinical trials in pediatric psychopharmacology. This article reviews essential ethical and scientific issues that are relevant to designing clinical trials in children with psychiatric and developmental disorders. Using examples from recently published literature, the article describes the challenges and pitfalls of various clinical trial study designs. The application of sound ethical and scientific principles is necessary to ensure that clinical trials are properly conducted and to guard against ambiguous results that can not guide practice. (shrink)

Social acceptance is assumed to have widespread positive effects on the recipient; however, ethnic/racial minorities often react negatively to social acceptance by White individuals. One possibility for such reactions might be their lack of trust in the genuineness of White individuals’ positive evaluations. Here, we examined the role that oxytocin—a neuropeptide putatively linked to social processes—plays in modulating reactions to acceptance or rejection during interracial interactions. Black participants received intranasal oxytocin or placebo and interacted with a White, same-sex stranger (...) who provided positive or negative social feedback. After positive feedback, participants given oxytocin tended to display approach-oriented cardiovascular responses of challenge, exhibited more cooperative behavior, and perceived the partner to have more favorable attitudes toward them after the interaction. Following negative feedback, oxytocin reduced anger suppression. Oxytocin did not modulate testosterone reactivity directly, but our exploratory analysis showed that the less participants suppressed anger during the interaction with their partner, the greater testosterone reactivity they displayed after the interaction. These results survived the correction for multiple testing with a false discovery rate of 20%, but not with a rate of 10 or 5%. Discussion centers on the interplay between oxytocin and social context in shaping interracial interactions. (shrink)

Compared with mainstream medicine and complementary and alternative therapies, the practice of psychotherapy has enjoyed a relative pass when it comes to ethical evaluation. Therefore, contributions to the, although slowly growing, body of literature on psychotherapy ethics are to be welcomed. In his paper ‘Psychotherapy, placebos, and informed consent’, Garson Leder takes issue with what he calls the ‘go open’ project in psychotherapy ethics—the idea that the so-called ‘common factors’ in therapy should be disclosed to prospective patients. Although Leder does (...) not give a detailed list, the common factors include therapist characteristics, patient characteristics, and the working alliance. He argues that the project advocating disclosure of these factors is flawed on two grounds: that information about common factors is not necessary for informed consent; and clarity about specific mechanisms of change in therapy is consistent with ‘many theory-specific forms of psychotherapy’. There are multiple serious problems with Leder’s critique of the recent literature, including how he represents the contours of the debate, which I list, and address in this response. (shrink)

Advertisements for pharmaceuticals may promote placebo responses by generating an expectation of therapeutic success. Some cite this as reason to favour Direct to Consumer Advertising of Prescription Pharmaceuticals (DTCA). Against this, I show placebo responses to emanate from beliefs rendered unjustified by the influence of a conditioning process. I argue that drug safety and efficacy are material properties and that unjustified beliefs in these domains entail costs to autonomy that outweigh any prudential gains attending a placebo (...) class='Hi'>response. I conclude that its placebogenic potential ought not to count as reason to favour DTCA. (shrink)