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 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)

Objectives -/- Surveys in various countries suggest 17% to 80% of doctors prescribe ‘placebos’ in routine practice, but prevalence of placebo use in UK primary care is unknown. Methods -/- We administered a web-based questionnaire to a representative sample of UK general practitioners. Following surveys conducted in other countries we divided placebos into ‘pure’ and ‘impure’. ‘Impure’ placebos are interventions with clear efficacy for certain conditions but are prescribed for ailments where their efficacy is unknown, such as antibiotics for (...) suspected viral infections. ‘Pure’ placebos are interventions such as sugar pills or saline injections without direct pharmacologically active ingredients for the condition being treated. We initiated the survey in April 2012. Two reminders were sent and electronic data collection closed after 4 weeks. Results -/- We surveyed 1715 general practitioners and 783 (46%) completed our questionnaire. Our respondents were similar to those of all registered UK doctors suggesting our results are generalizable. 12% (95% CI 10 to 15) of respondents used pure placebos while 97% (95% CI 96 to 98) used impure placebos at least once in their career. 1% of respondents used pure placebos, and 77% (95% CI 74 to 79) used impure placebos at least once per week. Most (66% for pure, 84% for impure) respondents stated placebos were ethical in some circumstances. Conclusion and implications -/- Placebo use is common in primary care but questions remain about their benefits, harms, costs, and whether they can be delivered ethically. Further research is required to investigate ethically acceptable and cost-effective placebo interventions. (shrink)

Recent debates over the use of sham surgery as a control for studies of fetal tissue transplantation for Parkinson’s disease have focused primarily on rival interpretations of the US federal regulations governing human-subjects research. Using the core ethical and methodological considerations that underwrite the equipoise requirement, we nd strong prima facie reasons against using sham surgery as a control in studies of cellular-based therapies for Parkinson’s disease and more broadly in clinical research. Additionally, we believe that these reasons can be (...) generalized to apply to the use of other placebo controls that carry signi cant risks of positive harms in and of themselves. As a result, our arguments are centrally relevant to the emerging drive to subject therapies with a surgical component to the same rigorous standards of evaluation as those governing the approval of new pharmaceuticals. (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)

Several authors have recently argued that psychotherapy, as it is commonly practiced, is deceptive and undermines patients’ ability to give informed consent to treatment. This ‘deception’ claim is based on the findings that some, and possibly most, of the ameliorative effects in psychotherapeutic interventions are mediated by therapeutic common factors shared by successful treatments, rather than because of theory-specific techniques. These findings have led to claims that psychotherapy is, at least partly, likely a placebo, and that practitioners of psychotherapy (...) have a duty to ‘go open’ to patients about the role of common factors in therapy ; to not ‘go open’ is supposed to unjustly restrict patients’ autonomy. This paper makes two related arguments against the ‘go open’ claim. While therapies ought to provide patients with sufficient information to make informed treatment decisions, informed consent does not require that practitioners ‘go open’ about therapeutic common factors in psychotherapy, and clarity about the mechanisms of change in psychotherapy shows us that the common-factors findings are consistent with, rather than undermining of, the truth of many theory-specific forms of psychotherapy; psychotherapy, as it is commonly practiced, is not deceptive and is not a placebo. The call to ‘go open’ should be resisted and may have serious detrimental effects on patients via the dissemination of a false view about how therapy works. (shrink)

In this paper, Isuggest that placebo effects, as we know them today, should be understood as experimental phenomena, low-level regularities whose causal structure is grasped through particular experimental designs with little theoretical guidance. Focusing on placebo interventions with needles for pain reduction -one of the few placebo regularities that seems to arise in meta-analytical studies- I discuss the extent to which it is possible to decompose the different factors at play through more fine-grained randomized clinical trials. My (...) sceptical argument is twofold. On the one hand, I argue that experiments alone are not enough to standardize interventions, and that it is necessary to include theories. On the other hand, I argue that the social interactions that seem to be part of placebo effects are difficult, if not impossible, to blind. Therefore, the measurement biases arising from the participants’ reactivity to the experimental setup cannot be controlled for. Further decomposition of placebo effects requires a theoretical account of the existing experimental regularities that may guide further tests. (shrink)

Despite the conceptual problems in identifying the placebo effect, an increasing number of multidisciplinary inquiries rest on the assumption that there is a distinct class of effects, placebo effects. In this chapter, I argue against this assumption. I present cases and characterizations of the placebo effect as offered in the literature, and argue that the latter are subject to insurmountable problems. Moreover, I argue that identification of placebo effects as such is not useful for the three (...) main purposes offered in the literature. I then offer suggestions for why it may remain intuitive that some effects are placebo effects and close by noting the potential benefits of ultimately explaining away these intuitions. (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)

In this short essay I intent to discuss the moral standing of autonomy in the field of Medical Ethics and the way it affects individual decision making as well as health care policies. To this purpose I will employ a real life scenario, namely administering placebo medication to a patient without letting him know, by means of which I will challenge not only the effectiveness and the feasibility of autonomy in the Kantian sense, but also its desirability. I will (...) argue that the Kantian notion of autonomy when it comes to Medical Ethics is in some cases self-defeating and, therefore, confusing and misleading. I will conclude with the view that, at least as Medical Ethics is concerned, we should rethink and, maybe, revise the meaning we usually assign to autonomy, so as to take into account the particular nature of the doctor-patient relationship. (shrink)

The achievement of optimal therapeutic results presupposes the use of appropriate treatment combined with maximal utilization of placebo effects. These aims may sometimes be difficult to satisfy in randomized clinical trials (RCTs). The question thus arises whether there is a conflict between the goals of therapy and those of experimental research; and if so, to what extent, and how is it handled in practice by clinicians and researchers. Various ethical problems have been discussed in several reports connected with RCTs. (...) But we have found no discussion concerning the conflict between obtaining informed consent and promoting optimal placebo effects. Information about RCTs can be given in various ways. Sometimes appropriate information about RCTs to patients involves non-optimal utilization of placebo effects. This gives rise to ethical and methodological problems, which are discussed in this article. (shrink)

In this paper, I provide a brief summary of the context, outline the arguments for and against the controversial use of placebo controls, and focus on particular areas that I believe merit further discussion or clarification. On balance, I argue that the researchers failed in their duties to protect the best interests of their research subjects, and to promote distributive justice. I discuss the difficulties of obtaining valid consent in this research context, and argue that it is unethical to (...) inform women of their 'HIV' status without at least offering them prophylactic treatment for their unborn children. (edited). (shrink)

What’s so bad about the placebo effect? John Worrall discusses the recent Nurofen labelling “scandal”.

Kihlbom has recently argued that a system of seeking negatively informed consent might be preferable in some cases to the ubiquitous informed consent model. Although this theory is perhaps not powerful enough to supplant informed consent in most settings, it lends strength to Evans’ and Hungin’s proposal that it can be ethical to prescribe placebos rather than "active" drugs. This paper presents an argument for using negatively informed consent for the specific purpose of authorising the use of placebos in clinical (...) contexts. (shrink)

The placebo drug reactions from controlled trials were studied for the first time systematically for efficacy and the safety in drug data pooled from randomized, placebo-controlled, multicentre studies. Results: The efficacy of placebo on clinical symptoms and outcome varied between the therapeutic indications. However, no placebo effects on laboratory values, as e.g. blood glucose or Hb1c in diabetics, were noted. The frequency and type of placebo-induced adverse reactions also varied between indication groups. The placebo (...) side effect profile was largely similar to the side effect profile of the active treatment. The mechanisms of placebo effects are manyfold and varied (e.g. endorphin release, conditioning), much lacks explanation. Conclusion: Since the prescription of non-evidence based medicines (= pseudoplacebos) may clearly also result in serious adverse effects, such practice may not only be non-beneficial but may even be harmful. In clinical research, the judicious use of placebo remains essential to establish the efficacy and safety, safeguarding that patients receiving placebo will not be subject to harm and are fully informed. (shrink)

While a significant body of bioethical literature considers how the placebo effect might introduce a conflict between autonomy and beneficence, the link between justice and the placebo effect has been neglected. Here, we bring together disparate evidence from the field of placebo studies and research on health inequalities related to race and ethnicity, and argue that, collectively, this evidence may provide the basis for an unacknowledged route by which health disparities are exacerbated. This route is constituted by (...) an uneven distribution of placebo effects, resulting from differences in expressions of physician warmth and empathy, as well as support and patient engagement, across racial and ethnic lines. In a discussion of the ethical implications of this connection, we argue that this contribution to health disparities is a source of injustice, consider ways in which these disparities might be ameliorated and suggest that this conclusion is likely to extend to other realms of inequality as well. (shrink)

Placebos are allegedly used widely in general practice. Surveys reporting high level usage, however, have combined two categories, ‘pure’ and ‘impure’ placebos. The wide use of placebos is explained by the high level usage of impure placebos. In contrast, the prevalence of the use of pure placebos has been low. Traditional pure placebos are clinically ineffective treatments, whereas impure placebos form an ambiguous group of diverse treatments that are not always ineffective. In this paper, we focus on the impure (...) class='Hi'>placebo concept and demonstrate problems related to it. We also show that the common examples of impure placebos are not meaningful from the point of view of clinical practice. We conclude that the impure placebo is a scientifically misleading concept and should not be used in scientific or medical literature. The issues behind the concept, however, deserve serious attention in future research. (shrink)

It is widely believed that medically inert treatments (“placebos”) can bring about therapeutic benefits. There is also evidence that medically active treatments may also have “placebo” effects. Since anything that has the potential to benefit patients ought to be exploited, subject to appropriate ethical standards, it has been suggested that more should be done to investigate and exploit the power of the placebo for therapeutic benefit. I explore the acute epistemic and ethical constraints that such exploitation is likely (...) to face, and conclude that effective exploitation is unlikely. (shrink)

The use of placebo controls in clinical trials remains controversial. Ethical analysis and international ethical guidance permit the use of placebo controls in randomized trials when scientifically indicated in four cases: (1) when there is no proven effective treatment for the condition under study; (2) when withholding treatment poses negligible risks to participants; (3) when there are compelling methodological reasons for using placebo, and withholding treatment does not pose a risk of serious harm to participants; and, more (...) controversially, (4) when there are compelling methodological reasons for using placebo, and the research is intended to develop interventions that can be implemented in the population from which trial participants are drawn, and the trial does not require participants to forgo treatment they would otherwise receive. The concept of methodological reasons is essential to assessing the ethics of placebo controls in these controversial last two cases. This article sets out key considerations relevant to considering whether methodological reasons for a placebo control are compelling. (shrink)

Robin Nunn has argued that we should stop using the terms ‘placebo’ and ‘placebo effect’. I argue in support of Nunn’s position by considering the logic of why we perform placebo comparisons. Like all comparisons, placebo comparison is just a case of comparing one thing with another, but it is a mistake, I argue, to think of placebo comparison as a case where something is compared to ‘a placebo’. Rather, placebo comparison should be (...) understood as a situation which sets-up the treatment and control groups in a particular way; not as a case involving objects or procedures called ‘placebos’ employed in order to control for ‘placebo effects’. (shrink)

Throughout history up until present, many cultures have traditionally experienced the effects of verifiable healings, along with hexes, curses, witchcraft, voodoo, and other mysterious phenomena. These effects-many of which were elicited by unscientific means-were brought about by the beliefs and lore of the society. Even today, pharmaceutical companies use double- and triple-blind randomized studies in an attempt to exclude of the power of the mind over the body. In You Are the Placebo, Dr. Joe Dispenza explores the history, the (...) science, and the practical applications of the so-called placebo effect. Citing many amazing individual cases studies, this compelling book will empower you to personally use "the expectation of a particular outcome" to alter your internal states-as well as external reality-solely through the action of your mind. It offers the necessary understandings to change old beliefs and perceptions into new ones. In addition, it teaches a model of personal transformation that correlates with the placebo effect-without the need for any external influences ("placebos" such as sugar pills, saline injections, and so on). You Are the Placebo combines the latest research in neuroscience, biology, psychology, hypnosis, behavioral conditioning, and quantum physics to demystify the workings of the placebo effect. and show how the seemingly impossible can become possible. (shrink)

Placebo-controlled trials are held by many, including regulators at agencies like the United States Food and Drug Administration, to be the gold standard in the assessment of new medical interventions. Yet the use of placebo controls in clinical trials has been the focus of considerable controversy. In this two-part article, we challenge a number of common beliefs concerning the value of placebo controls. Part I critiques statistical and other scientific justifications for the use of placebo controls (...) in clinical research. The continued use of placebo controls in clinical trials on diseases for which accepted treatment exists raises equally important ethical, legal, and regulatory issues for which various justifications have been given. Defense of this practice relies on normative as well as empirical myths.In their attack on the prevailing use of placebo controls, Kenneth Rothman and Karin Michels emphasize that this practice stands in violation of the World Medical Association's guidelines on the ethics of human experimentation, most commonly known as the Helsinki Declaration. (shrink)

It has been almost 20 years since the field of bioethics was galvanized by a controversial series of multinational AZT trials employing placebo controls on pregnant HIV-positive women in the developing world even though a standard of care existed in the sponsor countries. The trove of ethical investigations that followed was thoughtful and challenging, yet an important and problematic methodological assumption was left unexplored. In this article, I revisit the famous “double standard of care” case study in order to (...) offer novel consideration of the placebo orthodoxy that underlies much of the ethical debate. This majority view found in medical research is that placebo-controlled trials are methodologically superior to comparative trials that use active controls. I challenge this orthodoxy and argue that lives were unnecessarily lost in these trials as a result. Furthermore, current HIV research on vaccines and microbicides is now poised to repeat the error of subscribing to the placebo orthodoxy. (shrink)

In a recent article in this Journal, Shlomo Cohen and Haim Shapiro introduce the concept of “comparable placebo treatments” —placebo treatments with biological effects similar to the drugs they replace—and argue that doctors are not being deceptive when they prescribe or administer CPTs without revealing that they are placebos. We critique two of Cohen and Shapiro’s primary arguments. First, Cohen and Shapiro argue that offering undisclosed placebos is not lying to the patient, but rather is making a self-fulfilling (...) prophecy—telling a “lie” that, ideally, will become true. We argue that offering undisclosed placebos is not a “lie” but is a straightforward case of deceptively misleading the patient. Second, Cohen and Shapiro argue that offering undisclosed CPTs is not equivocation. We argue that it typically is equivocation or deception of another sort. If justifiable, undisclosed placebo use will have to be justified as a practice that is deceptive in most instances. (shrink)

A humorous short story about a company that tries marketing a placebo as a more expensive drug on the grounds that doing this will both maximize their profits and benefit the greatest number, since research shows the placebo to be highly effective if marketed as something else.

Randomised clinical trials involve procedures such as randomisation, blinding, and placebo use, which are not part of standard medical care. Patients asked to participate in RCTs often experience difficulties in understanding the meaning of these and their justification.

The place for the placebo in human clinical research is addressed in this paper. The World Medical Association which is comprised of some 80 National Medical Associations uses much of its resources to address medical ethics and human rights issues. It adopted the Declaration of Helsinki in June 1964 which addressed the protection of individuals in clinical trials. The use of placebos assumes an important role in this document. Five Revisions of the Declaration of Helsinki have occurred and the (...) most recent was adopted in October 2000. The provisions on placebo are now in Paragraph 29 which reads as follows:“The benefit, risks, burdens and effectiveness of a new method should be tested against those of the best current prophylactic, diagnostic and therapeutic methods. This does not exclude the use of placebo, or no treatment, in studies where no proven prophylactic, diagnostic or therapeutic methods exists.”The reactions to the newly revised version of the Declaration of Helsinki were numerous and rapid, not the least of which was the paragraph I quoted above.At the direction of the WMA Council, a small group of experts together with the WMA workgroup studied the Paragraph 29 to ensure that no ethically sound research was being restricted by the revision. The outcome was approved by the Council and later the WMA General Assembly in October 2000. This gives a note of clarification as to the appropriate use of placebos. Numerous papers and statements over the last several years have described positions very much in line with the Note of Clarification cited above. (shrink)

His words effectively assert, within a scientific context, that the mental realities that comprise a person’s stream of conscious experiences can influence the state of that person’s physically described body. That claim neither follows naturally from, nor meshes rationally with, the basic physical theory that, in 1799, had prevailed in science for more than a century---since the 1687 publication of Isaac Newton’s Principia---and that would continue to prevail for an additional century, until its replacement during the twentieth century by quantum (...) theory. It is this later theory that, according to the precepts of contemporary physics, must in principle be used to describe the dynamics of the ions and other microelements that underlies the brain processes associated with the mental realties. Unlike its predecessor, quantum mechanics was specifically designed to deal with the complex relationship between the empirical aspects of science represented in our sensory experiences and the physically described properties represented in our physical theories. This incorporation of the mental allows quantum theory to provide a rationally coherent understanding of influence mind upon body identified in the epigraph. The aim of this presentation is to describe this quantummechanical understanding to an audience of neurologists. (shrink)

Use of a placebo control in surgical trials is a divisive issue. We argue that, in principle, placebo controls for surgery are necessary in the same way as for medicine. However, there are important differences between these types of trial, which both increase justification and limit application of surgical studies. We propose that surgical randomised placebo-controlled trials are ethical if certain conditions are fulfilled: the presence of equipoise, defined as a lack of unbiased evidence for efficacy of (...) an intervention; clinically important research question; the risk to patients is minimised and reasonable; there is uncertainty about treatment allocation rather than deception; there is preliminary evidence for efficacy, which justifies a placebo-controlled design; and ideally, the placebo procedure should have some direct benefit to the patient, for example, as a diagnostic tool. Placebo-controlled trials in surgery will most often be justified when surgery is performed to improve function or relieve symptoms and when objective outcomes are not available, while the risk of mortality or significant morbidity is low. In line with medical placebo-controlled trials, the surgical trial should be sufficiently powered and standardised so that its results are valid, consent should be valid, the standard treatment or rescue medication should be provided if possible, and after the trial, the patients should be told which treatment they received and there should be provision for post-trial care if the study may result in long-term negative effects. We comment and contrast our guidelines with those of the American Medical Association. (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)

Recent research, especially with functional brain imaging, demonstrated cases where the administration of a placebo produces objective effects in tissues that are indistinguishable from those of the real therapeutic agents. This phenomenon has been shown in treatments of pain, depression, Parkinsonism, and more. The main ethical complaint against placebo treatment is that it is a kind of deception, where supposedly we substitute what works just psychologically for a real drug that actually works on the tissue level. We claim (...) that the scientific findings bring to a new level the seeming deconstruction of the distinction between “placebo” and “real” drugs, and that instances of placebo treatment which fulfill this criterion should be recognized as a unique category—we call it “comparable placebo treatment” (CPT). The paper uses an analysis of the notion of deception to argue that CPT does not amount to deception; that it can preserve patient autonomy; and that it is therefore morally legitimate. (shrink)

The UK Medical Research Council, in order to further its mission of maintaining and improving human health, supports a substantial number of clinical trials on a wide variety of medical questions; some of these trials involve the use of placebos as controls or to maintain blinding. Before providing support, proposed trials are carefully reviewed to assess scientific quality, and to determine whether a placebo is required and is ethical — in addition to ethics review by independent Research Ethics Committees. (...) Some questions such as the choice of placebos in trials in developing countries, in surgical trials and those involving alternative medicine require consideration of additional, specific issues. Involvement of consumers in MRC work has been increasing and includes the establishment of a Consumer Liaison Group; members of this group comment on patient information leaflets for clinical trials, helping to improve patient understanding of trials and ensuring topics like placebo use are explained clearly. Views differ on the value of placebos in clinical care and on their mechanism of action; continuing research is helping to clarify the issues. (shrink)

In April 1999, Dr. Curt Freed of the University of Colorado in Denver and Dr. Stanley Fahn of Columbia Presbyterian Center in New York presented the results of a four-year, $5.7 million government-financed study using tissue from aborted fetuses to treat Parkinson’s disease at a conference of the American Academy of Neurology. The results of the first government-financed, placebo-controlled clinical study using fetal tissue showed that the symptoms of some Parkinson’s patients had been relieved. This research study involved forty (...) subjects, nineteen women and twenty-one men; all suffered from Parkinson’s disease for an average of 13.5 years. In the study, each subject underwent neurosurgery: “four tiny burr holes, drilled through the wrinkle lines above the eyebrows into the skull, to clear a pathway to the brain. But only half received injections of fetal cells into the putamen, the region of the brain that controls movement; the other half received nothing. One year later, three members of the placebo group said their symptoms had improved.” In two-thirds of the transplant recipients, the fetal tissue took hold and seemed to establish a new network to produce the missing neurochemical dopamine. (shrink)

This paper gives an overview of the placebo effect in popular culture, especially as it pertains to the work of authors Patrick O’Brian and Sinclair Lewis. The beloved physician as placebo, and the clinician scientist as villain are themes that respectively inform the novels, The Hundred Days and Arrowsmith. Excerpts from the novels, and from film show how the placebo effect, and the randomized clinical trial, have emerged into popular culture, and evolved over time.

This article considers issues concerning cases where the use of placebo is lawful or is not lawful under aspects of German criminal law. It will differentiate between cases of individual therapy and cases of supervised experiments within the scope of medical tests. Thereby, it reveals that a medication of placebo with regard to an individual patient seems to be lawful if there is no alternative possibility of a better treatment using a chemically effective medicine and if the limits (...) of presumed consent are complied with. On the other hand, in the context of the supervised experiment, the assignment of a patient to a group treated with placebo is only lawful if the patient has been fully informed about the possibilities of a treatment and if the patient has given consent to it. (shrink)

Placebos are commonly defined as ineffective treatments. They are treatments that lack a known mechanism linking their properties to the properties of the condition on which treatment aims to intervene. Given this, the fact that placebos can have substantial therapeutic effects looks puzzling. The puzzle, we argue, arises from the relationship placebos present between culturally meaningful entities, our intentional relationship to the environment and bodily effects. How can a mere attitude toward a treatment result in appropriate bodily changes? We argue (...) that an ‘enactive’ conception of cognition accommodates and renders intelligible the phenomenon of placebo effects. Enactivism depicts an organism’s adaptive bodily processes, its intentional directedness, and the meaningful properties of its environment as co-emergent aspects of a single dynamic system. In doing so it provides an account of the interrelations between mind, body and world that demystifies placebo effects. (shrink)

A much-cited definition of placebo is from Shapiro and Shapiro :"any therapy that is intentionally or knowingly used for its nonspecific, psychological, or psychophysiological, therapeutic effect, or that is used for a presumed specific therapeutic effect on a patient, symptom, or illness but is without specific activity for the condition being treated". What nonspecific means and how it relates to the psyche has been written about extensively yet inconclusively. In the end, the term nonspecific doesn't say anything about the (...) crux of the matter.Talking about placebo, one first has to distinguish between " placebo effect proper" and "perceived placebo effect." The. (shrink)

A placebo is an intervention that is believed to lack specific pharmacological or physiological efficacy for a patient’s condition. While placebo-controlled trials are considered the gold standard when it comes to researching and testing new pharmacological treatments, the use of placebos in clinical practice is more controversial. The focus of this case study is an undisclosed placebo trial used as an attempt to diagnose a patient’s complex and unusual symptomology. In this case, the placebo was used (...) not just as a treatment, but as a diagnostic intervention in order to determine the best course of treatment for a patient. Could the deceptive use of a placebo be justified in clinical practice on the grounds of beneficence? (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)

American orthodox medicine consolidated its professional authority in the early 20th Century on the basis of its unbiased scientific method. The centerpiece of such a method is a strategy for identifying truly effective new therapies, i.e., the randomized clinical trial (RCT). A crucial component of the RCT in illnesses without established treatment is the placebo control. Placebo effects must be identified and distinguished from pharmacological effects because placebos produce actual but unexplained therapeutic successes. The blinding necessary for a (...) proper placebo-controlled RCT therefore introduces an epistemic bias into orthodox medicine: therapeutic successes that rely upon a direct link between knowing and healing, such as placebo effects, are discarded in favor of therapeutic successes that rely upon an indirect link between knowing and healing, such as pharmacological interventions. Where the capacity to produce therapeutic results once validated the method of clinical medical science, now method validates results. The clinical consequences of this method of testing therapies include a diminished vision of the therapeutic potential of the doctor-patient relationship and of the potential human resources available for healing. Keywords: doctor-patient relationship, epistemology, placebo effect, professionalization, randomized clinical trials CiteULike Connotea Del.icio.us What's this? (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)