The nocebo effect, a phenomenon whereby learning about the possible side effects of a medical treatment increases the likelihood that one will suffer these side effects, continues to challenge physicians and ethicists. If a physician fully informs her patient as to the potential side effects of a medicine that may produce nocebogenic effects, which is usually conceived of as being a requirement associated with the duty to respect autonomy, she risks increasing the likelihood that her (...) patient will experience these side effects and therefore suffer (unnecessary) harm, a violation of the duty of nonmaleficence. If, on the other hand, she intentionally withholds side effect information in an effort to protect her patient from suffering unnecessary harm from side effects, which is consistent with the duty of nonmaleficence, she violates the duty to respect patient autonomy. In this paper, the author discusses several previous attempts to deal with the nocebo effect and explains their weaknesses. He then proposes a means of managing the nocebo effect and argues that it does not share the weaknesses found in previous approaches. He concludes with a discussion of a simple, yet practical tool that might help clinicians manage the tension resulting from the nocebo effect. (shrink)

The nocebo effect, the mirror-phenomenon to the placebo effect, is when the expectation of a negative outcome precipitates the corresponding symptom or leads to its exacerbation. One of the basic ethical duties in health care is to obtain informed consent from patients before treatment; however, the disclosure of information regarding potential complications or side effects that this involves may precipitate a nocebo effect. While dilemmas between the principles of respect for patient autonomy and of nonmaleficence are recognized (...) in medical ethics, there has not yet been an ethical discussion focused on the potential dilemma raised by the nocebo effect of informed consent. This dilemma is especially pernicious, since it involves a direct causality of harm by the caregiver that is unparalleled by other potential harmful effects of information disclosure. This paper articulates the dilemma of the NEIC and offers a seminal ethical analysis. (shrink)

In her paper, ‘Sharing online clinical notes with patients: implications for nocebo effects and health equity’, Blease bridges findings from two research fields to describe possible unintended consequences of providing patients access to clinical notes. 1 She explains how nocebo effects, genuine psychological and physiological reactions following negative expectations, may arise after patients read such notes. Blease emphasises that the likelihood of nocebo may be greater for those patient groups who experience stigmatisation in healthcare. We (...) argue that this is the case for patients with so-called medically unexplained symptoms (MUSs) and that clinicians who work with them should consider nocebo but not for the reasons they may think. MUS is a term used to refer to persistent physical symptoms which cannot be fully or reliably attributed to a structural pathology. They include common symptoms such as chronic or recurrent pain in joints and muscles, fatigue, paresthesia or digestive... (shrink)

Warning research participants and patients about potential risks associated with participation/treatment is a fundamental part of consent. However, such risk warnings might cause negative expectations and subsequent nocebo effects (i.e., negative expectations cause negative outcomes) in participants. Because no existing review documents how past research has quantitatively examined nocebo effects – and negative expectations – arising from consent risk warnings, we conducted a pre-registered scoping review (N = 9). We identified several methodological issues across these studies, (...) which in addition to mixed findings, limit conclusions about whether risk warnings cause nocebo effects. (shrink)

Background Thorough information of the patient is an integral part of the process of shared decision making. We aimed to investigate if detailed information about medication may induce nocebo effects. Methods We conducted a randomized, single-blind, pilot-study including n = 51 psychiatric in-patients aged between 18 and 80 years with a depressive disorder and accompanying sleeping disorders. In the intervention group we provided thorough information about adverse effects, while the control group received only a simple consent procedure. (...) In both groups, patients received an open-label placebo pill instead of their sleeping medication. Results No statistically significant differences between the intervention group and the control group were found regarding the main outcome parameter. Conclusion In this study, we were not able detect an effect of informed consent vs. simple consent on the emergence of placebo or nocebo effects. This finding is contrary to most assumptions and publications about this topic. Trial registration Trial registration number: DRKS00017653, registered August 30th 2018. Retrosprectively registered. (shrink)

Introduction:The effects of specific suggestions are usually studied by measuring parameters that are directly addressed by these suggestions. We recently proposed the use of a uniform, unrelated, and objective measure like maximal muscle strength that allows comparison of suggestions to avoid nocebo effects and thus to improve communication. Since reduced breathing strength might impair respiration and increase the risk of post-operative pulmonary complications, the aim of the present study was to evaluate the effects of the suggestions (...) on respiratory muscle power. Both the identification and neutralization of negative suggestions in the clinical context and stimulating suggestions could improve breathing force, a predictor of physical fitness and convalescence.MethodsIn 50 healthy, adult volunteers, respiratory muscle strength was measured by maximal inspiratory and expiratory pressures, as well as by maximal inspiratory and expiratory flows. Baseline was compared to values after application of eleven suggestions, five out of clinical context, including memory of negative or positive past, risk information for informed consent, and a non-verbal suggestion. Six stimulating suggestions included self-affirmation, empowering words, a heroic mirror image, and an imagination.ResultsAll suggestions showed an impact on respiratory muscle strength, indicating placebo and nocebo effects. No single parameter could represent the breathing force in its complexity, however, trends and different specific aspects of it were measured. The strongest reaction was observed with the recall of a previous negative situation resulting in a reduction in expiratory flow to 96.1% of baseline. After risk information, a decrease was observed in three of the parameters, with the highest extend in expiratory pressure by 4.4%. This nocebo effect was neutralized by adding positive aspects to the risk information. Every intended strengthening suggestion resulted in statistically significant increases of at least one parameter, with changes of up to 10%, indicating placebo effects. Here, expiration was more affected than inspiration. Sex was the only influencing factor reaching statistical significance, with stronger reactions in women.ConclusionRespiratory muscle strength proved to be sensitive to suggestions with clinical context, as well as suggestions intended for stimulation. With this objective measurement, evaluation, and comparison of different suggestions is possible to help avoid nocebo effects. The demonstrated effect of supporting suggestions can be followed up and used in clinical practice. (shrink)

This article on the potential for patient online records access (ORA) to increase the likelihood of nocebo effects is timely, 1 given the recent introduction of full prospective records access for primary care patients in England. 2 Blease provides a convincing overview of the evidence for the nocebo effect and examines the complex interplay with health inequities. The article proposes two mechanisms for ORA augmenting nocebo effects through: (A) patients reading about possible negative outcomes of (...) treatments and (B) a negative clinician tone or less supportive content in the notes diminishing patient trust and setting up negative expectations. Blease notes a small percentage of those who had used ORA at least once during the previous year in one study reported feeling more worried about their medications, 3 and that those with mental health diagnoses were significantly more prone to this than those without such diagnoses.shrink)

Nocebo effects occur when an individual experiences undesirable physiological reactions caused by doxastic states that are not a treatment’s core or characteristic features.1 As Scott Gelfand2 points out, there are numerous studies that have shown that the disclosure of a treatment’s side effects to a patient increases the risk of the side effects. From an ethical point of view, nocebo effects caused by the disclosures of side effects present a challenging problem. On the (...) one hand, clinicians’ duty to inform patients of the consequences (including possible side effects) of their treatments is critical in ensuring that patients’ autonomy is respected. Patients cannot act autonomously if relevant information is withheld from them (without their consent, perhaps). On the other hand, clinicians also ought to minimize harm to patients. (shrink)

The American Journal of Bioethics, Volume 12, Issue 3, Page 37-39, March 2012.

IntroductionIn the context of giving risk information for obtaining informed consent, it is not easy to comply with the ethical principle of “primum nihil nocere.” Carelessness, ignorance of nocebo effects and a misunderstood striving for legal certainty can lead doctors to comprehensive and brutal risk information. It is known that talking about risks and side effects can even trigger those and result in distress and nonadherence to medication or therapy.MethodsRecently, we have reported on significant clinically relevant (...) class='Hi'>effects of verbal and non-verbal suggestions on maximal muscular arm strength in healthy volunteers and in patients at two time points before surgery. Maximal strength during arm abduction was measured by dynamometry of the deltoid muscle group. Suggestions from clinical everyday life were formulated as presumed negative and neutral versions.ResultsHere, we report on the effects of two versions of risk information in 45 patients. After sole mentioning risks of a puncture for the placement of a pain catheter, the maximal arm muscle strength was significantly reduced to 83% of baseline several days, and to 84% the evening before surgery. Strength was not significantly decreased and close to baseline at T1 and T2 when risks and benefits of a pain catheter were combined in one sentence. The difference between both versions was significant. With persistent normal distribution of values, the effect was due to uniform reactions of many patients, not to strong reactions of a few. High suggestibility and increase of anxiety with approaching surgery were identified as influencing factors for the neutralizing effect of modified wording.ConclusionWe not only suggest an alternative formulation for risk information to avoid nocebo effects but present an objective method to quantify and compare effects of different wordings. Thereby, we provide evidence that concurrently given positive aspects can neutralize negative effects during medical interview. (shrink)

Nocebo effects occur when an adverse effect on the patient arises from the patient's own negative expectations. In accordance with informed consent, providers often disclose information that results in unintended adverse outcomes for the patient. While this may adhere to the principle of autonomy, it violates the doctrine of “primum non nocere,” given that side-effect disclosure may cause those side effects. In this article we build off previous work, particularly by Wells and Kaptchuk and by Cohen :3–11.[Taylor (...) & Francis Online], [Web of Science ®] [Google Scholar]), to suggest ethical guidelines that permit nondisclosure in the case when a nocebo effect is likely to occur on of the basis of nonmaleficence. We accept that that autonomy vis-à-vis informed consent must be forestalled, but salvage much of its role by elaborating a practical clinical approach to postencounter follow-up. In doing so, we reconcile a clinically practicable process of determining conditions of disclosure with long-standing ethical commitments to patients. (shrink)

In “Two Minds, One Patient: Clearing Up Confusion About ‘Ambivalence,’” Moore and colleagues provide a sophisticated and subtle taxonomy of ambivalence. As they explain, clinical ethicists a...

Patients in around 20 countries worldwide are now offered online access to at least some of their medical records. Access includes test results, medication lists, referral information, and/or the very words written by clinicians (so-called ‘open notes’). In this paper, I discuss the possibility of one unintended negative consequence of patient access to their clinical notes—the potential to increase ‘nocebo effects’. A growing body of research shows that nocebo effects arise by engaging perceptual and cognitive processes (...) that influence negative expectancies, and as a consequence, adverse health effects. Studies show that increased awareness about the side effects of medications, the framing of information and the socioemotional context of care can increase the risk of nocebo effects. Connecting research into the nocebo effect with open notes provides preliminary support for the hypothesis that patient access to clinical notes might be a forum for facilitating unwanted nocebo effects. Furthermore, current findings indicate that we might expect to see systematic differences in how nocebo effects are experienced among different patient populations. The ethical implications of the tension between transparency and the potential for harm are discussed, with an emphasis on what open notes might mean for justice and equity in clinical care for a range of already marginalised patient populations. I argue that to resolve these challenges does not thereby justify ‘closed notes’, and conclude with suggestions for how health systems and clinicians might adapt to this innovation to reduce the risk of potential nocebo effects arising via this novel route. (shrink)

The principle of informed consent obligates physicians to explain possible side effects when prescribing medications. This disclosure may itself induce adverse effects through expectancy mechanisms known as nocebo effects, contradicting the principle of nonmaleficence. Rigorous research suggests that providing patients with a detailed enumeration of every possible adverse event—especially subjective self-appraised symptoms—can actually increase side effects. Describing one version of what might happen (clinical “facts”) may actually create outcomes that are different from what would have (...) happened without this information (another version of “facts”). This essay argues that the perceived tension between balancing informed consent with nonmaleficence might be resolved by recognizing that adverse effects have no clear black or white “truth.” This essay suggests a pragmatic approach for providers to minimize nocebo responses while still maintaining patient autonomy through “contextualized informed consent,” which takes into account possible side effects, the patient being treated, and the particular diagnosis involved. (shrink)

Nocebo effects occur when an individual experiences undesirable physiological reactions caused by doxastic states that are not a treatment’s core or characteristic features.1 As Scott Gelfand2 points out, there are numerous studies that have shown that the disclosure of a treatment’s side effects to a patient increases the risk of the side effects. From an ethical point of view, nocebo effects caused by the disclosures of side effects present a challenging problem. On the (...) one hand, clinicians’ duty to inform patients of the consequences (including possible side effects) of their treatments is critical in ensuring that patients’ autonomy is respected. Patients cannot act autonomously if relevant information is withheld from them (without their consent, perhaps). On the other hand, clinicians also ought to minimize harm to patients. (shrink)

The American Journal of Bioethics, Volume 12, Issue 3, Page 30-31, March 2012.

Unlike its friendly cousin the placebo effect, the nocebo effect (the effect of expecting a negative outcome) has been almost ignored. Epistemic and ethical confusions related to its existence have gone all but unnoticed. Contrary to what is often asserted, adverse events following from taking placebo interventions are not necessarily nocebo effects; they could have arisen due to natural history. Meanwhile, ethical informed consent (in clinical trials and clinical practice) has centred almost exclusively on the need to (...) inform patients about intervention risks with patients to preserve their autonomy. Researchers have failed to consider the harm caused by the way in which the information is conveyed. In this paper, I argue that the magnitude of nocebo effects must be measured using control groups consisting of untreated patients. And, because the nocebo effect can produce harm, the principle of non-maleficence must be taken into account alongside autonomy when obtaining (ethical) informed consent and communicating intervention risks with patients. (shrink)

Individuals with idiopathic environmental illness with attribution to electromagnetic fields (IEI-EMF) claim they experience adverse symptoms when exposed to electromagnetic fields (EMFs) from mobile telecommunication devices. However, research has consistently reported no relationship between exposure to EMFs and symptoms in IEI-EMF individuals. The current study investigated whether presence of symptoms in IEI-EMF individuals were associated with a nocebo effect. Data from two previous double-blind provocation studies were re-analyzed based on participants’ judgments as to whether or not they believed a (...) telecommunication base station was “on” or “off.” Experiment 1 examined data in which participants were exposed to EMFs from Global System for Mobile Communication, Universal Mobile Telecommunications System, and sham base station signals. In Experiment 2, participants were exposed to EMFs from Terrestrial Trunked Radio Telecommunications System and sham base station signals. Our measures of subjective well-being indicated IEI-EMF participants consistently reported significantly lower levels of well-being, when they believed the base station was “on” compared to “off.” Interestingly, control participants also reported experiencing more symptoms and greater symptom severity when they too believed the base station was “on” compared to “off.” Thus, a nocebo effect provides a reasonable explanation for the presence of symptoms in IEI-EMF and control participants. (shrink)

I am grateful for the variety of feedback. Three themes struck me: first, commentators recognised the value of open notes but underlined the importance of exploring unintended consequences of the innovation particularly for already disadvantaged populations; second, they suggested nocebo effects might arise via additional routes not identified in my paper; third, they signalled the need for further empirical and ethical exploration of nocebo effects. Exploring all three issues and offering a commentary that was equal parts (...) intriguing and perturbing, Chang and Torous proposed nocebo effects and other harms might be ubiquitous in the digital health space. 1 For example, they hypothesised that the preoccupation with checking health tracking data including adverse readings or outcomes available via downloadable apps and wearable devices might induce nocebo effects. This supposition is worthy of further scrutiny. Chang and Torous also highlighted the lack of research into potentially disparate effects of digital... (shrink)

Unlike its friendly cousin the placebo effect, the nocebo effect has been almost ignored. Epistemic and ethical confusions related to its existence have gone all but unnoticed. Contrary to what is often asserted, adverse events following from taking placebo interventions are not necessarily nocebo effects; they could have arisen due to natural history. Meanwhile, ethical informed consent has centred almost exclusively on the need to inform patients about intervention risks with patients to preserve their autonomy. Researchers have (...) failed to consider the harm caused by the way in which the information is conveyed. In this paper, I argue that the magnitude of nocebo effects must be measured using control groups consisting of untreated patients. And, because the nocebo effect can produce harm, the principle of non-maleficence must be taken into account alongside autonomy when obtaining informed consent and communicating intervention risks with patients. There are no data in this work. (shrink)

A growing body of evidence suggests that the informed consent process, in which patients are warned about potential side effects of a treatment, can trigger a nocebo effect where expectations about side effects increase side effect occurrence. This has sparked an ethical debate about how much information patients ought to receive before a treatment while trying to balance the moral principles of patient autonomy and nonmaleficence. In keeping with the principle of patient autonomy, the opinion of patients (...) themselves in relation to how much information they want about side effects is of utmost relevance in this debate. The literature was searched to identify surveys assessing patient attitudes towards side effect information. Across a broad variety of patient populations, treatment types, and countries, the majority of patients wished to be fully informed of potential side effects, particularly in relation to frequent and severe side effects, while only a small minority wanted minimal or no information at all. Results from this review suggest that nocebo research should focus on methods of avoiding nocebo effects of informed consent while ensuring that patients are well-informed about potential side effects. (shrink)

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

The American Journal of Bioethics, Volume 12, Issue 3, Page 33-34, March 2012.

Direct-to-consumer advertising is banned in Australia, and instead pharmaceutical companies use disease awareness campaigns as a strategy to raise public awareness of conditions for which the company produces a treatment. This practice has been justified by promoting individual autonomy and public health, but it has attracted criticism regarding medicalisation of normal health and ageing, and exaggeration of the severity of the condition in question, imbalanced reporting of risks and benefits, and damaging the patient–clinician relationship. While there are benefits of disease (...) awareness promotion, there is another possible adverse consequence that has not yet been rigorously considered: the possibility of inducing a nocebo response via the campaign. We will discuss the creation of a nocebo response in this context. (shrink)

This Perspective adapts the ViolEx Model, a framework validated in several clinical conditions, to better understand the role of expectations in the recovery and/or maintenance of musculoskeletal pain. Here, particular attention is given to the condition in which dysfunctional expectations are maintained despite no longer being supported by confirmatory evidence. While the ViolEx Model suggests that cognitive immunization strategies are responsible for the maintenance of dysfunctional expectations, we suggest that such phenomenon can also be understood from a Bayesian Brain perspective, (...) according to which the level of precision of the priors is the determinant factor accounting for the extent of priors’ updating. Importantly, this Perspective translates the theory behind these two frameworks into clinical suggestions. Precisely, it is argued that different strategies should be implemented when treating MSK pain patients, depending on the nature of their expectations. (shrink)

BackgroundResearch has demonstrated that personality characteristics, such as optimism are associated with placebo/nocebo responding. The present study investigated whether written information about the optimism of a placebo/nocebo provider can influence the occurrence of reported placebo/nocebo side effects.MethodWe analyzed data from 201 females who participated in a “clinical study on a new massage oil with stone clover extract.” The oil was introduced as either eliciting a negative side effect or a positive side effect. The administration of the (...) oil was combined with written information about the maker of the product. The oil maker was either portrayed as a very optimistic person or no personal information was provided. The participants had no personal contact with the experimenter and received all materials and instructions per post.ResultsThe participants reported more frequent and intense itching when they received a nocebo suggestion compared to a placebo suggestion. Positive tingling sensations were reported more frequently than itching but did not differ between the placebo/nocebo conditions. Information about the optimism of the oil maker was associated with a lower frequency of reported side effects.ConclusionThis study demonstrated that it is sufficient to provide participants with written information about an inert substance to elicit the suggested side effect. Information about the provider’s optimistic personality did not specifically influence reported side effects. Future studies should focus on how to adapt written information about a drug/product to minimize adverse side effects and to maximize positive side effects. (shrink)

“Nocebo,” a term coined in the mid-twentieth century, refers to the onset of negative side effects in individuals who anticipate harm from biomedical treatment. Sylvia Wynter invokes nocebo effects as racializing phenomena that demonstrate the injurious impact of colonial practices. By soliciting insights from Nocebo Studies, as well as Wynter and Achille Mbembe, this article explores decolonial philosophies of selfhood, especially in terms of the meaning-making expressivity of selves. This conversation between Nocebo Studies and (...) Wynter proffers ways to engage with nocebo effects as mani-festations of the structures of colonial violence, while undercutting biomedical accounts of nocebos that presuppose an overly generic human body. (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)

In this article, Charlotte Blease argues that patient access to online shared clinical notes (also called ‘open notes’) may cause or exacerbate nocebo effects in two ways. 1 First, open notes may enhance patient understanding about the adverse effects of medications and treatments. However, reading information about adverse effects may lead patients to form negative expectations that, in turn, may cause or worsen symptoms via nocebo mechanisms. Second, open notes may paradoxically lower the quality of (...) the therapeutic relationship by allowing patients to detect signs of discrimination and stigma in clinical notes. By accessing their shared notes, patients may identify (or think that they are identifying) signs of stigmatisation and discrimination in clinicians’ words. This may diminish their trust while increasing their anxieties and fears, all factors that have been associated with enhanced nocebo effects. The article then suggests different strategies to mitigate nocebo effects while using open... (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)

Introduction Patients require an accurate knowledge about placebos and their possible effects to ensure consent for placebo-controlled clinical trials is adequately informed. However, few previous studies have explored patients’ baseline levels of understanding and knowledge about placebos. The present online survey aimed to assess knowledge about placebos among patients with a history of back pain. Design A 15-item questionnaire was constructed to measure knowledge about placebos. Additional questions assessed sociodemographic characteristics, duration and severity of back pain, and previous experience (...) of receiving placebos. Setting Participants recruited from community settings completed the study online. Results 210 participants completed the questionnaire. 86.7% had back pain in the past 6 months, 44.3% currently had back pain. 4.3% had received a placebo intervention as part of a clinical trial and 68.1% had previously read or heard information about placebos. Overall knowledge of placebos was high, with participants on average answering 12.07 of 15 questions about placebos correctly. However, few participants correctly answered questions about the nocebo effect and the impact of the colour of a placebo pill. Conclusions The findings identified key gaps in knowledge about placebos. The lack of understanding of the nocebo effect in particular has implications for the informed consent of trial participants. Research ethics committees and investigators should prioritise amending informed consent procedures to incorporate the fact that participants in the placebo arm might experience adverse side 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 underreporting of suspected adverse drug reactions hinders pharmacovigilance. Solutions to underreporting are oftentimes directed at clinicians and health care professionals. However, given the recent rise of public inclusion in medical science, solutions may soon begin more actively involving patients. I aim to offer an evaluative framework for future possible proposals that would engage patients with the aim of mitigating underreporting. The framework may also have value in evaluating current reporting practices. The offered framework is composed of three criteria that (...) are bioethical, social-epistemic, and pragmatic: (i) patients should not be exposed to undue harms, e.g., nocebo effects; (ii) data should be collected, analyzed, and communicated prioritizing pharmacovigilance’s aims, i.e., free from industry bias; and (iii) proposals should account for existing and foreseeable pragmatic constraints like clinician ‘buy in’ and existing reporting infrastructure. Proposals to engage patients in pharmacovigilance that fulfil or address these criteria are preferable to those that do not. (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)

The importance of preserving trust in physicians and in medical institutions has received widespread attention in recent years. Primarily, this is due to the threats to trust posed by managed care, but there is a general and growing recognition that trust deserves more attention than it traditionally has received in all aspects of medical ethics, law, and public policy. Trust has both intrinsic and instrumental value. Trust is intrinsically important because it is a core characteristic that affects the emotional and (...) interpersonal aspects of the physician/patient relationship. As an instrumental value, trust is widely believed to be essential for effective therapeutic encounters. It has been hypothesized or shown to affect a host of important behaviors and attitudes relating to care, including seeking care, disclosing private information, complying with treatment, and being satisfied with care. Moreover, trust may be a mediator of measurable clinical outcomes and a key factor in the mind–body interactions that underlie placebo/nocebo effects and the effectiveness of alternative medicine. It is no surprise, then, that preserving, justifying, and enhancing trust is the fundamental goal of much of medical ethics, and is a prominent objective in healthcare law and public policy. Discussions of trust and related concepts were commonplace in professionally based medical ethics prior to the 1970s. a 1 2. (shrink)

With more countries implementing Open Notes, the practice of providing patients with unhindered access to their clinical visit notes, research on this practice is finally increasing. Many studies report positive findings, especially around self-reported outcomes, such as feeling more in control of one’s care, increased medication adherence and a strengthened patient–doctor relationship. 1 However, comparatively less research has been done on the potential ramifications that may also arise from Open Notes. Blease’s recent article underscores this and demonstrates why Open Notes (...) must also be considered in terms of nocebo effects, negative side effects that arise from negative expectations. 2 The article presents a compelling and well-thought-out argument for how nocebo effects may vary across different populations by linking patient–clinician communication inequalities with and by presenting preliminary evidence of nocebo effects. Blease’s argument does not detract from Open Notes, but rather takes a balanced approach by imploring us... (shrink)

Increasing numbers of health organisations are offering some or all of their patients access to the visit notes housed in their electronic health records. In some countries, including Sweden and the USA, this innovation is advanced with patients using online portals to access their clinical records including the visit summaries written by clinicians. In many countries, patients can legally request copies of their records; however, open notes are different because this innovation offers patients rapid, real-time access via electronic devices. In (...) this brief report, we explore what open notes might mean for placebo use in clinical care. Survey research into patient access to their clinical notes shows that increased transparency enhances patients’ understanding about their medications and augments engagement with their care. We reflect on the consequences of access for placebo prescribing, particularly for the common practice of deceptive placebo use, in which patients are not aware they are being offered a placebo. In addition, we explore how open notes might facilitate placebo and nocebo effects among patients. Bridging placebo studies with medical ethics, we identify a range of empirical research gaps that now warrant further study. (shrink)

When someone steps on your toe on purpose, it seems to hurt more than when the person does the same thing unintentionally. The physical parameters of the harm may not differ—your toe is flattened in both cases—but the psychological experience of pain is changed nonetheless. Intentional harms are premeditated by another person and have the specific purpose of causing pain. In a sense, intended harms are events initiated by one mind to communicate meaning (malice) to another, and this could shape (...) the recipient’s experience. This study examined whether self-reported pain is indeed higher when the events producing the pain are understood as intentionally (as opposed to unintentionally) caused by another person. Although pain was traditionally conceived to be solely physical in nature (Aydede, 2005), its experience varies substantially with psychological context. The placebo analgesia effect, for example, is the reduction of pain without a change in physical stimulation when context, expectations, or sugar pills challenge the interpretation of a sensation as painful (e.g., Fields, 2008). The nocebo effect, in turn, is the experience of pain without any physical stimulation—as when participants report headaches when told that a (nonexistent) electric current is passing through their heads (Schweiger & Parducci, 1981). These variations in pain experience seem to depend on the meaning of the stimulus: A sugar pill is meant to decrease pain, whereas electric current is meant to increase pain. In an interpersonal context, the meaning of an action is derived from the would complete. perceiver’s perceptions of the actor’s intention (Clark, 1996). (shrink)