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)

Health care providers are expected both to relieve pain and to provide anticipatory guidance regarding how much a procedure is going to hurt. Fulfilling those expectations is complicated by the cognitive modulation of pain perception. Warning people to expect pain or setting expectations for pain relief not only influences their subjective experience, but it also alters how nociceptive stimuli are processed throughout the sensory and discriminative pathways in the brain. In light of this, I reconsider the characterization of placebo analgesia (...) as pharmacologically inert and the use of it as deceptive. I show that placebo analgesia exploits the same physical mechanisms as proven analgesics and argue that it should be utilized to relieve pain. Additionally, I describe factors to help identify situations in which clinicians have the obligation to disclose the potential for pain coupled with ways of mitigating the risk of high-intensity pain by setting positive expectations. (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)

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)

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)

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)

Fortunato and colleagues' target article extends both the ethical analysis and the clinical practice of nondisclosure by focusing on nocebo effects (Fortunato, Wasserman, and Menkes 2017). Instance...

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)

Legal precedent, professional‐society statements, and even many medical ethicists agree that some situations may call for a clinician to engage in an act of lying or nonlying deception of a patient or patient's family member. Still, the moral terrain of clinical deception is largely uncharted, and when it comes to practical guidance for clinicians, many might think that ethicists offer nothing more than the rule never to deceive. This guidance is insufficient to meet the real‐world demands of clinical practice, and (...) this article endeavors to articulate a framework to help clinicians better navigate the ethics of clinical deceit. The framework articulates four morally relevant dimensions of a potential deceptive act that should be examined to better determine the moral justification that might be required: the target of the act, the nature of the information, the nature of the act, and the context of the act. (shrink)

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 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)