If placebos have been squeezed out of medicine to the point where their official place is in clinical trials designed to identify their own confounding effect, the placebo effect nevertheless thrives in psychotherapy. Not only does psychotherapy dispose of placebo effects that are less available to medicine as it becomes increasingly technological and preoccupied with body parts, but factors of the sort inhibiting the use of placebos in medicine have no equivalent in psychology. Medicine (...) today is disturbed by the placebo effect in a way psychotherapy is not. Psychotherapy does not have to grapple with such a disconcerting paradox as successful sham surgery, and unlike those physicians who once pretended to treat the patient’s body while actually attempting to treat the mind, the psychotherapist can treat the mind in all frankness. Perhaps it is because psychotherapy is less burdened by doubts about the placebo effect that it was able to come to its aid when it was orphaned by medicine. It is vain to expect something with so long a history as the placebo effect to disappear from the practices of healing. (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)

Placebos are much discussed in both the medical and philosophy of medicine literatures. Once narrowly defined as inert “sugar pills,”, they now are now most often taken to be “treatments that appear similar to experimental treatments, but that lack their characteristic components”. In addition to their use in the control groups of many clinical trials, placebos are also now widely recognized by medical practitioners to be powerful therapies in themselves, often outperforming conventional drug therapies in these studies.Given (...) this, I find Haller’s book, which is divided into six chapters, “Evidence Based Medicine,” “Postmodernist Medicine,” “The Powerful Placebo,” “Politics of... (shrink)

Pekka Louhiala crosses disciplines and decades to present a remarkably detailed review of the existing literature on placebos, placebo effects, and related concepts. The problem at hand—and Louhiala does aptly frame it as a problem—is a striking lack of consensus among researchers, scholars, and clinicians regarding virtually all aspects of the placebo topic. In capturing the complexity of this problem, Louhiala expertly compiles an extensive catalog of placebo literature that effectively gives the reader both a map of the territory (...) and a legend to decipher it. He does not, however, give us clear directions to find our way out of the conceptual maze. The focus is often more on the problems than their solutions, which is simultaneously the most notable weakness and the greatest strength of the book. (shrink)

Can there be scientific theories in psychology, medicine or psychiatry? I approach this question through an in-depth analysis of a typical experiment for clinical depression involving the monoamine hypothesis, drug action, and placebos. I begin my discussion with a reconstruction of Adolph Grünbaum's conceptual analysis of 'placebo,' and then use his notion of "intentional placebo" to discuss a typical experiment using the monoamine hypothesis, two drugs and a placebo. I focus on the theoretical aspects of the experiment, especially (...) on the notion of causal explanation. I then raise five conceptual and methodological problems for theory construction. These problems focus on questions of the causal efficacy of placebos and drugs; ad hoc versus ceteris paribus explanations in biomedicine and psychology; and the falsifiability of the monoamine hypothesis. I conclude by pointing out the need for further, rigorous philosophical analysis concerning the possibility of theory construction in psychology, medicine, or psychiatry. (shrink)

Does it work? This question lies at the very heart of the kinds of controversies that have surrounded complementary and alternative medicines (such as herbal medicine) in recent decades. In this article, I argue that medical anthropology has played a pivotal and largely overlooked role in taking the sham out of the placebo effect with important implications for what it means to say a therapy or drug `works'. If pharmacologists and clinicians have corporeally located the concept of efficacy in (...) terms of bio-availability, pharmacodynamics and pharmacokinetics, and herbalists in terms of a herbal revitalizing of the body's own vis medicatrix naturae, from the early 20th century onwards medical anthropologists (especially those who became interested in the `savage mind') have built up an equally rigorous theory of symbolic efficacy in terms of narratives, symbols and a kind of cognitive homeostasis. It was precisely as a mediating link between the somatic and the symbolic that I suggest a decriminalized placebo effect (as opposed to suggestion) could emerge in the middle of the 20th century. Taking the example of St John's Wort, I go on to show how notions of symbolic efficacy, spillover placebo efficacy and bio-efficacy co-circulate in recent attempts by herbalists, clinicians and pharmacologists to address the question of whether or not this herbal remedy `works' in the treatment of depression. (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)

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)

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)

This chapter begins by debunking some of the myths and misconceptions surrounding placebo effects, through a survey of some of the discoveries that have been made in the last fifty years about the range, frequency, and potency of placebo effects in medicine and psychiatry. It then looks at how placebo effects make an appearance in psychiatry and psychotherapy, particularly in the case of treatments of depression that involve psychoactive medication and/or talk therapy. Following this is a survey of some (...) of the leading definitions of the placebo effect, as well as a survey of some of the leading explanatory theories. The chapter concludes with a discussion of some new directions in placebo research: namely, open-label placebos and the evolutionary origins of placebo effects. (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)

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 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)

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)

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)

Placebo effects raise some fundamental questions concerning the nature of clinical and medical research. This Element begins with an overview of the different roles placebos play, followed by a survey of significant studies and dominant views about placebo mechanisms. It then critically examines the concept of placebo and offers a new definition that avoids the pitfalls of other attempts. The main philosophical lesson is that background medical theories provide the ontology for clinical and medical research. Because these theories often (...) contain incoherent and arbitrary classifications, the concept of placebo inherits the same messiness. The Element concludes by highlighting some impending challenges for placebo studies. (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 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)

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)

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)

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)

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)

The doctor-patient relationship is built on an implicit covenant of trust, yet it was not until the post-World War Two era that respect for patient autonomy emerged as an article of mainstream medical ethics. Unlike their medical forebears, physicians today are expected to furnish patients with adequate information about diagnoses, prognoses and treatments. Against these dicta there has been ongoing debate over whether placebos pose a threat to patient autonomy. A key premise underlying medical ethics discussion is the notion (...) that the placebo effect necessitates patient deception. Indeed, the American Medical Association guidelines imply that placebo treatment necessary entails a form of deception. As a consequence of this assumption, the fulcrum of debate on the use of placebo treatment has hinged on whether that deception is ever justified. Recently performed experiments with open-label transparently prescribed placebos have begun to challenge the notion that deception is necessary in eliciting the placebo effect and such effects necessarily involve a binary distinction between autonomy and beneficence. In this article we focus on the content of disclosures in distinctive open-label, transparently disclosed placebo studies and inquire whether they might be said to invoke deception in clinical contexts, and if so, whether the deception is unethical. We find that open placebos may be said to involve equivocation over how placebos work. However, drawing on surveys of patient attitudes we suggest that this equivocation appears to be acceptable to patients. We conclude that open placebos fulfil current American Medical Association guidelines for placebo use, and propose future research directions for harnessing the placebo effect ethically. (shrink)

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)

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)

Doctor–patient communication is a crucial component in any therapeutic encounter. Physicians use words to formulate diagnoses and prognoses, to disclose the risks and benefits of medical interventions, and to explain why, how, and when a therapy will be administered to a patient. Likewise, patients communicate to describe their symptoms, to make sense of their conditions, to report side effects, to explore other therapeutic options, and to share their feelings. Throughout the history of medicine, the ethics of the doctor–patient communication (...) has been traditionally grounded on considerations of paternalistic beneficence and nonmaleficence. In this respect, it was no different from the ethics regulating.. (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)

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 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)

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)

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)

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)

Debates about the ethics and effects of placebos and whether ‘placebos’ in clinical trials of complex treatments such as acupuncture are adequate rage. Yet there is currently no widely accepted definition of the ‘placebo’. A definition of the placebo is likely to inform these controversies. Grünbaum’s characterization of placebos and placebo effects has been touted by some authors as the best attempt thus far, but has not won widespread acceptance largely because Grünbaum failed to specify what he (...) means by a therapeutic theory and because he does not stipulate a special role for expectation effects. Grünbaum claims that placebos are treatments whose ‘characteristic features’ do not have therapeutic effects on the target disorder. I show that with four modifications, Grünbaum’s definition provides a defensible account of placebos for the purpose of constructing placebo controls within clinical trials. The modifications I introduce are: adding a special role for expectations, insisting that placebo controls control for all and only the effects of the incidental treatment features, relativizing the definition of placebos to patients, and introducing harmful interventions and nocebos to the definitional scheme. I also provide guidance for classifying treatment features as characteristic or incidental. (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)

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)

The leading ethical position on placebo-controlled clinical trials is that whenever proven effective treatment exists for a given condition, it is unethical to test a new treatment for that condition against placebo. Invoking the principle of clinical equipoise, opponents of placebo-controlled trials in the face of proven effective treatment argue that they (1) violate the therapeutic obligation of physicians to offer optimal medical care and (2) lack both scientific and clinical merit. We contend that both of these arguments are mistaken. (...) Clinical equipoise provides erroneous ethical guidance in the case of placebo-controlled trials, because it ignores the ethically relevant distinction between clinical trials and treatment in the context of clinical medicine and the methodological limitations of active-controlled trials. Placebo controls are ethically justifiable when they are supported by sound methodological considerations and their use does not expose research participants to excessive risks of harm. (shrink)

Die ethischen Aspekte der Verwendung von Placebos in klinischen Versuchsreihen wurden im letzten Jahrzehnt ausführlich und kontrovers diskutiert. Es fehlt dennoch eine gründliche vergleichende Analyse der verschiedenen internationalen Richtlinien, ihrer Terminologien und ihrer auf Placebo bezogenen Prinzipien. Das zentrale Problem ist die Rechtfertigung von Placebo bei einer nachgewiesen wirksamen Therapie. Alle aktuellen Versionen der untersuchten Richtlinien schlagen solche Rechtfertigungen vor, unterscheiden sich hierbei jedoch beträchtlich. Zunächst werden wir ein formales allgemeines Prinzip herausarbeiten. Dann werden wir drei verschiedene Kategorien von (...) Kriterien darstellen: das Schadensrisiko oder die Belastung, zwingende wissenschaftliche Gründe und die Erhältlichkeit einer nachgewiesen wirksamen Therapie. Die Analyse zeigt bedeutende normative Abweichungen und Widersprüche innerhalb und zwischen den einzelnen Richtlinien. Besonders frappierend ist es, dassmancheRichtlinien es erlauben, Versuchsteilnehmer dem Risiko eines schweren Schadens auszusetzen, während andere gerade dies untersagen. Abschließend versuchen wir zu zeigen, wie sich die normativen Unterschiede bei der Entscheidungsfindung von Forschern und Ethikkommissionen auswirken können. (shrink)

Many extant theories of placebo focus on their causal structure wherein placebo effects are those that originate from select features of the therapy (e.g., client expectations or “incidental” features like size and shape). Although such accounts can distinguish placebos from standard medical treatments, they cannot distinguish placebos from everyday occurrences, for example, when positive feedback improves our performance on a task. Providing a social-epistemological account of a treatment context can rule out such occurrences, and furthermore reveal a new (...) way to distinguish clinical placebos from standard medical treatments. (shrink)

The use of placebo in clinical practice has been the topic of extensive debate in the bioethics literature, with much scholarship focusing on concerns regarding deception. While considerations of placebo without deception have largely centred on open-label placebo, this paper considers a different kind of ethical quandary regarding placebo without an intent to deceive—one where the provider believes a treatment is effective due to a direct physiological mechanism, even though that belief may not be supported by rigorous scientific evidence. This (...) is often the case with complementary and alternative medicine (CAM) techniques and also with some mainstream therapies that have not proven to be better than sham. Using one such CAM technique as a case study—electroencephalography (EEG) neurofeedback for attention-deficit/hyperactivity disorder (ADHD)—this paper explores the ethics of providing therapies that may have some beneficial effect, although one that is likely due to placebo effect. First, we provide background on EEG neurofeedback for ADHD and its evidence base, showing how it has proven to be equivalent to—but not better than—sham neurofeedback. Subsequently, we explore whether offering therapies that are claimed to work via specific physical pathways, but may actually work due to the placebo effect, constitute deception. We suggest that this practice may constitute unintentional deception regarding mechanism of action. Ultimately, we argue that providers have increased information provision obligations when offering treatments that diverge from standard of care and we make recommendations for mitigating unintentional deception. (shrink)