Experimental Assessment of Nocebo Effects and Nocebo Side Effects: Definitions, Study Design, and Implications for Psychiatry and Beyond

Faasse, Kate; Helfer, Suzanne G.; Barnes, Kirsten; Colagiuri, Ben; Geers, Andrew L.

doi:10.3389/fpsyt.2019.00396

Cited by 19 publications

(21 citation statements)

References 16 publications

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“…The prototypical example involves a sugar pill administered under the guise of a painkiller that relieves pain despite containing no active ingredients. Nocebo effects are the “dark side” of the placebo effect, whereby harmful outcomes are similarly triggered by aspects of the treatment context (Faasse, Helfer, Barnes, Colagiuri, & Geers, 2019). For example, warnings about side effects can induce side effects from inert treatments (Neukirch & Colagiuri, 2015).…”

Section: Introductionmentioning

confidence: 99%

Affect and emotions in placebo and nocebo effects: What do we know so far?

Geers

Faasse

Guevarra

et al. 2020

Social & Personality Psych

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Once considered nuisance variance in clinical trials, placebo effects and nocebo effects are now widely recognized as important and mutable psychobiological contributors to mental and physical health. Psychological theory explaining these effects emphasizes associative learning and conscious expectations. It has long been suggested, however, that affective states such as moods, emotions, and distress could play a significant role. In this paper, we draw together and review the empirical data linking affective states to placebo and nocebo effects. To organize this disparate literature, three questions are addressed: (1) Does pre‐existing state and trait affect modulate placebo and nocebo effects? (2) Does administering placebo and nocebo treatments change affective states, and if so, does the resulting affect causally influence placebo and nocebo effects? Finally, (3) Can placebo treatments be successfully employed as a regulation strategy to modulate different affective states? In reviewing the evidence in relation to these three questions, it is clear that affect does play a key role in placebo and nocebo effects in many circumstances, and further, there may be a reciprocal dynamic at play between a treatment event, affect, and placebo/nocebo effects. The paper concludes by discussing implications for theory and intervention and recommends future research priorities.

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Section: Introductionmentioning

confidence: 99%

Affect and emotions in placebo and nocebo effects: What do we know so far?

Geers

Faasse

Guevarra

et al. 2020

Social & Personality Psych

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“…A somewhat similar effect has been reported by Colloca et al (2008) who showed that non-painful tactile stimulation could be turned into a pain sensation via verbal nocebo suggestions in healthy participants. Moreover, Faasse et al (2019) concluded in their overview article that nocebo side effects are weaker compared to the effects of primary nocebos.…”

Section: Discussionmentioning

confidence: 99%

“…While placebos improve a person’s condition (e.g., reduction of negative symptoms), nocebo treatment is associated with the occurrence of negative symptoms, the worsening of a condition, or the prevention of improvement ( Moerman and Jonas, 2002 ; Häuser et al, 2012 ). This definition has been specified by Faasse et al (2019) who differentiate between primary placebo/nocebo effects and placebo/nocebo side effects. For example, when using a primary nocebo the potential adverse outcome is framed as the focal effect of the inert treatment, whereas a nocebo side effect refers to an adverse outcome that is ancillary to the typically beneficial outcome of the inert treatment.…”

Section: Introductionmentioning

confidence: 99%

Information About the Optimism of a Placebo/Nocebo Provider and Placebo/Nocebo Side Effects

Schlintl

Schienle

2021

Front. Psychol.

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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 (mean age = 26 years) who participated in a “clinical study on a new massage oil with stone clover extract.” The oil (sunflower oil) was introduced as either eliciting a negative side effect (unpleasant itching; “nocebo oil”) or a positive side effect (pleasant tingling; “placebo oil”). 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 (only the company name). 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 (adverse and beneficial).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.

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“…Due to high liability risks for treatment errors, informed consent for surgery and related consent forms often focus on risk-centered information [3,4,7]. The way of presenting treatment risks can affect patients' anxiety and the nocebo effect, which can be defined as 'unpleasant or adverse outcomes triggered by the treatment context, beyond any inherent […] effects of the treatment itself' [8][9][10][11]. Previous research shows that supporting documents (e.g., informed consent forms) used in practice are heterogeneous [12,13] and that they are often deficient regarding the communication of risks [13].…”

Section: Background and Rationalementioning

confidence: 99%

Development, piloting, and evaluation of an evidence-based informed consent form for total knee arthroplasty (EvAb-Pilot): a protocol for a mixed methods study

Weise

Lühnen

Bühn

et al. 2021

Pilot Feasibility Stud

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Background Practitioners frequently use informed consent forms to support the physician-patient communication and the informed consent process. Informed consent for surgery often focuses on risk centered information due to high liability risks for treatment errors. This may affect patients’ anxiety of adverse events and the nocebo effect. This study focuses on the optimization of pre-surgical information on risks and complications, and at the same time reconciles these information with legal requirements. Methods The development, piloting, and evaluation of evidence-based informed consent forms for total knee arthroplasty (TKA) and related anesthesia procedures will follow the UK MRC Framework for developing and evaluating complex interventions. Conducting different sub-studies, we will (I) qualitatively explore the information acquisition and decision-making processes, (II) develop and pilot test evidence-based informed consent forms on the example of TKA and related anesthesia procedures, (III) conduct a monocentric interrupted time series (ITS) pilot study to evaluate the effects of evidence-based informed consent forms in comparison with standard consent forms, and (IV) perform a process evaluation to identify barriers and facilitators to the implementation of the intervention and to analyze mechanisms of impact. Discussion The evidence-based and understandable presentation of risks in informed consent forms aims at avoiding distorted risk depiction and strengthening the patients’ competencies to correctly assess the risks of undergoing surgery. This might reduce negative expectations and anxiety of adverse events, which in turn might reduce the nocebo effect. At the same time, the practitioners’ acceptance of evidence-based informed consent forms meeting legal requirements could be increased. Trial registration ClinicalTrials.gov, NCT04669483. Registered 15 December 2020. German Clinical Trials Registry, DRKS00022571. Registered 15 December 2020

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Experimental Assessment of Nocebo Effects and Nocebo Side Effects: Definitions, Study Design, and Implications for Psychiatry and Beyond

Cited by 19 publications

References 16 publications

Affect and emotions in placebo and nocebo effects: What do we know so far?

Affect and emotions in placebo and nocebo effects: What do we know so far?

Information About the Optimism of a Placebo/Nocebo Provider and Placebo/Nocebo Side Effects

Development, piloting, and evaluation of an evidence-based informed consent form for total knee arthroplasty (EvAb-Pilot): a protocol for a mixed methods study

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