Consider the following patient: a 40-year-old man who has had back pain that radiates down his left leg, on and off for 2 months. He performs his normal activities and does not have any “red flag”...

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

Placebos are often used by clinicians, usually deceptively and with little rationale or evidence of benefit, making their use ethically problematic. In contrast with their typical current use, a provocative line of research suggests that placebos can be intentionally exploited to extend analgesic therapeutic effects. Is it possible to extend the effects of drug treatments by interspersing placebos? We reviewed a database of placebo studies, searching for studies that indicate that placebos given after repeated administration of active treatments acquire medication-like (...) effects. We found a total of 22studies in both animals and humans hinting of evidence that placebos may work as a sort of dose extender of active painkillers. Wherever effective in relieving clinical pain, such placebo use would offer several advantages. First, extending the effects of a painkiller through the use of placebos may reduce total drug intake and side effects. Second, dose-extending placebos may decrease patient dependence. Third, using placebos along with active medication, for part of the course of treatment, should limit dose escalation and lower costs. Importantly, provided that nondisclosure is pre-authorized in the informed consent process and that robust evidence indicates therapeutic benefit comparable to that of standard full-dose therapeutic regimens, introducing dose-extending placebos into the clinical arsenal should be considered. This novel prospect of placebo use has the potential to change our general thinking about painkiller treatments, the typical regimens of painkiller applications, and the ways in which treatments are evaluated. (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)

This paper offers a critical analysis of several accounts of the placebo effect that have been put forward. While the placebo effect is most often thought of as a control in research and as a deceptive tool in practice, a growing body of research suggests that it ought to be thought of as a powerful phenomenon in its own right. Several accounts that aim to draw boundaries around the placebo effect are evaluated in relation to current evidence and it is (...) argued that none of them adequately capture the variability and potency of the phenomenon. Two accounts, however, that point towards the underlying mechanisms of the placebo effect, are shown to offer promise in terms of developing a more comprehensive account of the placebo effect. (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)

Over the decades of experimentation on the placebo effect, it has become clear that it is driven largely by expectation, and that strong expectations of efficacy are more likely to give rise to the experience of benefit. No wonder the placebo effect has come to resemble a self-fulfilling prophecy. However, this resemblance is considerably exaggerated. The placebo effect does not work as strongly as it is advertised to do in some efforts to elicit it. Half-truths about the placebo effect are (...) now in circulation, reinforced by a number of other equivocations that it seems to attract. As the deceptive use of placebos has fallen into discredit, the use of half-truths and exaggerations—neither of which is technically a deception—becomes an ever more inviting possibility. However, there are risks and costs associated with the half-truth that the doctor possesses the power to make his or her words come true by the alchemy of the placebo effect. (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)

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)

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)

The conceptual and ethical challenges regarding clinical placebo are interwoven with each other, so that one's definition of clinical placebo influences the moral reasoning with regard to its use i...

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)

Informed consent, as Alfano (2015) recognizes, has been routinely idealized within philosophical debate: Philosophers typically present a psychologically sanitized formulation of the temporal seque...