The Nocebo Effect and Informed Consent—Taking Autonomy Seriously

2020 ◽  
Vol 29 (2) ◽  
pp. 223-235
Author(s):  
SCOTT GELFAND
Keyword(s):  
Informed Consent ◽  
Side Effects ◽  
Medical Treatment ◽  
Side Effect ◽  
Patient Autonomy ◽  
The Other ◽  
Nocebo Effect ◽  
Other Hand ◽  
Patient Will ◽  
Practical Tool

AbstractThe 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.

scholarly journals Using Positive Attribute Framing to Attenuate Nocebo Side Effects: A Cybersickness Study

2021 ◽  
Author(s):  
Alanna Mao ◽  
Kirsten Barnes ◽  
Louise Sharpe ◽  
Andrew L Geers ◽  
Suzanne G Helfer ◽  
...  
Keyword(s):  
Virtual Reality ◽  
Informed Consent ◽  
Side Effects ◽  
Healthy Volunteers ◽  
Empirical Data ◽  
Side Effect ◽  
Spatial Awareness ◽  
Nocebo Effect ◽  
Positive Attribute ◽  
To Receive

Abstract Background Side effect warnings can contribute directly to their occurrence via the nocebo effect. This creates a challenge for clinicians and researchers, because warnings are necessary for informed consent, but can cause harm. Positive framing has been proposed as a method for reducing nocebo side effects whilst maintaining the principles of informed consent, but the limited available empirical data are mixed. Purpose To test whether positive attribute framing reduces nocebo side effects relative to negative framing, general warning, and no warning. Methods Ninety-nine healthy volunteers were recruited under the guise of a study on virtual reality (VR) and spatial awareness. Participants were randomized to receive positively framed (“7 out of 10 people will not experience nausea”), negatively framed (“3 out of 10 people will experience nausea”), general (“a proportion of people will experience nausea”), or no side effect warnings prior to VR exposure. Results Receiving a side effect warning increased VR cybersickness relative to no warning overall, confirming that warnings can induce nocebo side effects. Importantly, however, positive framing reduced cybersickness relative to both negative framing and the general warning, with no difference between the latter two. Further, there was no difference in side effects between positive framing and no warning. Conclusions These findings suggest that positive framing not only reduces nocebo side effects relative to negative framing and general warnings, but actually prevents nocebo side effects from occurring at all. As such, positive attribute framing may be a cheap and ethical way to reduce nocebo side effects.

Management of Side Effects of Antidepressant Medications

Depression ◽  
2019 ◽  
pp. 241-256
Author(s):  
Rajnish Mago
Keyword(s):  
Side Effects ◽  
High Risk ◽  
Side Effect ◽  
Substantial Effect ◽  
The Other ◽  
Antidepressant Medications ◽  
Other Hand ◽  
Considerable Impact

Side effects of antidepressants are common, distressing, and impairing. They have a substantial effect on nonadherence to antidepressants, which is very common. Greater attention to learning about various strategies for preventing, reducing, and managing side effects may have a significant effect in improving the outcomes of treatment with antidepressants. Attention needs to be paid to both common, “nuisance” side effects and the uncommon or rare “medically serious” side effects. This chapter provides examples of both categories. While nuisance side effects may seem unimportant, in fact, they have a considerable impact on nonadherence. On the other hand, while medically serious side effects may be seen as uncommon or even rare, they can lead to serious consequences. In particular, clinicians who often treat patients who are at high risk of such medically serious side effects need to be thoroughly familiar with them. Clinicians who prescribe antidepressant medications are urged to have a menu of options for the management of side effects, ranging from simple, benign interventions to more active interventions that may carry risks of their own. The latter are often needed in situations where continuing that particular antidepressant, or type of antidepressant, is essential and stopping or changing it is not a reasonable option. In such situations, risk/benefit considerations require that the side effect be actively treated to allow the patient to stay on the medication. This chapter provides many examples of both simple and more active interventions for a variety of potential side effects of antidepressants.

SAT0119 PARADOXICAL NEUTROPHIL ACTIVATION BY ANTI-IL6 THERAPY: TRANSCRIPTOME ANALYSIS SHOWS A RATIONALE FOR DERMATOLOGICAL ADVERSE REACTIONS AND DECREASED NEUTROPHIL COUNTS AFTER TOCILIZUMAB TREATMENT

2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 993.1-994
Author(s):  
M. Sakamoto ◽  
A. Senoh ◽  
Y. Sato ◽  
H. Iijima ◽  
M. Yamaguchi ◽  
...  
Keyword(s):  
Side Effects ◽  
Peripheral Blood ◽  
Side Effect ◽  
Neutrophil Migration ◽  
Neutrophil Activation ◽  
The Other ◽  
Leukocyte Migration ◽  
Other Hand ◽  
Serious Infections ◽  
Go Terms

Background:Skin rashes as a side effect of Tocilizumab therapy (TCZ- Tx) has not been paid much attention, because the incidence was only 1~2% in the drug information sheets. However, we experienced several RA cases with development of various skin rashes associated with neutrophil activation after TCZ-Tx. On the other hand, it is well known that the neutrophil counts in peripheral blood decreases after TCZ-Tx, whereas it does not affect the rate of serious infections. The detailed mechanism is still unclear.Objectives:To detect the characteristics of the changes in gene expressions of peripheral blood associated with TCZ-Tx and the development of skin rashes as its side effect.Methods:Total of 14 RA patients with TCZ-Tx were included. Among them, 4 patients developed TCZ-related rashes (group S) and 10 patients did not show any side effects (group C). Peripheral whole blood at just before (pre) and 3 months after (post) TCZ-Tx from each patient were subjected to the analysis. Total RNAs were extracted with PAXgene miRNA kit and analyzed with next-generation sequencing. First, group C was investigated for the normal response to TCZ-Tx. Differentially expressed genes (DEGs) were selected by paired comparison (post vs. pre). And then, enrichment analysis using gene ontology (GO) terms were performed. Second, to explore the characteristics of group S, all expressed genes in 14 cases at just before TCZ-Tx were subjected to a hierarchical clustering analysis. The DEGs (group S vs. C and post vs. pre) were also investigated with weighted gene co-expression network analysis (WGCNA) and GO analysis. Meanwhile, the total eigengene expressions of the important modules identified by WGCNA in each cases were also calculated.Results:Surprisingly, 8 out of the top 10 enriched GO terms in the up-regulated genes were relevant to leukocyte activation such as ‘neutrophil migration” by the analysis of DEGs (post vs. pre) in group C. The cluster analysis of ‘pre’ genes confirmed that the patterns of gene expression between group S and C was different. WGCNA analysis of DEGs (group S vs. C) revealed that genes related to acute inflammation such as ‘leukocyte mediated immunity’ were activated in group S. Interestingly, it was not correlated with disease activity score (DAS) of RA. By the analysis of DEGs (post vs. pre) of upregulated genes, we found that the total eigengene expressions of the module enriched with genes related to ‘cell adhesion’ or ‘leukocyte migration’ were significantly increased in all cases of group S.Conclusion:This is the first evidence that the genes associated with neutrophil migration is significantly activated after TCZ-Tx. It is noteworthy that the gene activation was observed in cases without any side effects. The decreased neutrophil counts in peripheral blood have been known after initiation of TCZ-Tx, which did not affect the rate of serious infections. Recently, It was reported that TCZ affects neutrophil trafficking to the bone marrow1). Our findings will provide a rationale for its cause. On the other hand, we experienced several RA cases with development of various skin rashes associated with neutrophil activation after TCZ-Tx. However, majority of patients do not develop the side effect, even though genes related to ‘neutrophil migration’ are activated. In group S, our findings indicate that the genes related to ‘leukocyte mediated immunity’ was already activated at the initiation of treatment without correlating to DAS of RA, furthermore, the gene upregulation related to ‘leukocyte migration’ was more prominent after TCZ-Tx. Although it is difficult to predict the patients developing skin rashes before TCZ-Tx, we do not recommend to use TCZ for the patients with neutrophilic dermatosis which is often associated with RA.References: :[1]Lok LSCet al.,Eur J Clin Invest. 47(10):736-745 (2017).Disclosure of Interests: :Moe Sakamoto: None declared, Akemi Senoh: None declared, Yoshiharu Sato: None declared, Hiroshi Iijima: None declared, Mari Yamaguchi: None declared, Toshie Higuchi: None declared, Yoshinobu Koyama Grant/research support from: Eli-Lilly and Mochida., Speakers bureau: BMS, Ayumi, Chugai, Ono, Mitsubishi Tanabe, Abbvie and Eisai.

scholarly journals The Legal Consequences of Informed Consent for Doctors and Patients in Theurapeutic Agreements

2020 ◽  
Vol 3 (6) ◽  
Author(s):  
Iip Verra Selvia ◽  
Arief Suryono ◽  
Sapto Hermawan
Keyword(s):  
Informed Consent ◽  
Medical Treatment ◽  
Professional Association ◽  
Professional Standards ◽  
The Other ◽  
Medical Procedures ◽  
Object A ◽  
Other Hand ◽  
The Law ◽  
Legal Consequences

Informed consent is a requirement for the occurrence of therapeutic agreements between doctors and patients. Therapeutic agreements are agreements where healing effort (inspanningverbittenes) is constituted as legal object. A patient who has given a consent is considered to understand the benefits and risks of medical treatment he would receive. However, the existence of informed consent does not make any doctor immune to the law. If a doctor works outside the professional standards and operational standards that apply and is proven by the professional association, then a doctor could be sanctioned according to applicable regulations. On the other hand, the patient is required to be cooperative in providing information and complying with the medical procedures. The existence of a therapeutic agreement results in both doctor and patient being bound to each other's rights and obligations. Keywords: informed consent; therapeutic agreement; doctor; patient

scholarly journals Informing About the Nocebo Effect Affects Patients’ Need for Information About Antidepressants—An Experimental Online Study

2021 ◽  
Vol 12 ◽  
Author(s):  
Yvonne Nestoriuc ◽  
Yiqi Pan ◽  
Timm Kinitz ◽  
Ella Weik ◽  
Meike C. Shedden-Mora
Keyword(s):  
Informed Consent ◽  
Side Effects ◽  
Information Seeking ◽  
Side Effect ◽  
Experimental Manipulation ◽  
Informational Needs ◽  
Nocebo Effect ◽  
Chi Square ◽  
Beneficial Effects ◽  
Need For Information

Relevance: Understanding patients’ informational needs and adapting drug-related information are the prerequisites for a contextualized informed consent. Current information practices might rather harm by inducing nocebo effects.Objective: To investigate whether informing about the nocebo effect using a short information sheet affects patients’ need for information about antidepressants.Methods: A total of 97 patients taking recently prescribed antidepressants (≤4 months intake) were recruited over the internet and randomized to receiving either a one-page written information about the nocebo effect or a control text about the history of antidepressants. After experimental manipulation, informational needs about the side effects and mechanisms of antidepressants were assessed with 3 and 7 items on categorical and 5-point Likert scales. Group differences in informational needs were calculated with Chi-square tests and ANOVAs.Results: Patients received antidepressants for depression (84.5%) and/or anxiety disorders (42.3%). Three participants (6.0%) of the nocebo group reported previous knowledge of the nocebo effect. After the experimental manipulation, participants in the nocebo group reported a reduced desire for receiving full side effect information [X(4,97)2 = 12.714, Cramer’s V = 0.362, p = 0.013] and agreed more frequently to the usefulness of withholding information about possible side effects [X(4,97)2 = 14.878, Cramer’s V = 0.392, p = 0.005]. Furthermore, they desired more information about the mechanisms of antidepressants (F = 6.373, p = 0.013, partial η2 = 0.063) and, specifically, non-pharmacological mechanisms, such as the role of positive expectations (F = 16.857, p < 0.001, partial η2 = 0.151).Conclusions: Learning about the nocebo effect can alter patients’ informational needs toward desiring less information about the potential side effects of antidepressants and more information about general mechanisms, such as expectations. The beneficial effects of including nocebo information into contextualized informed consent should be studied clinically concerning more functional information-seeking behavior, which may ultimately lead to improved treatment outcomes, such as better adherence and reduced side effect burden.

scholarly journals AKTUALISASI REVOLUSI MENTAL DALAM PENGELOLAAN DANA DESA (ANALISIS TAFSIR EKONOMI Q.S.YUSUF [12]: 55)

2020 ◽  
Vol 5 (2) ◽  
pp. 226-246
Author(s):  
Muhammad Amin ◽  
Azima Azima
Keyword(s):  
Side Effects ◽  
The Other ◽  
Other Hand ◽  
The Village

Dana Desa are one of the most effective policies in village development with the completion of various kinds of infrastructure in the village. On the other hand, this policy caused side effects in the form of criminal acts of corruption against these funds. Through the interpretation of Q.S. Yusuf verse 55, the author offers the actualization of the spirit of mental revolution in the management of village funds through measures to strengthen integrity, increase professionalism, innovation, responsibility, and broaden horizons. Through these steps, the village fund policy can be implemented completely and right on target.

scholarly journals On the issue of asepsis during laparotomy

1892 ◽  
Vol 6 (9) ◽  
pp. 825-845
Author(s):  
M. Mirenov
Keyword(s):  
Side Effects ◽  
The Other ◽  
Clinical Observations ◽  
Other Hand ◽  
The One

Clinical observations of recent years, showing, on the one hand, that the use of the antiseptic method in surgery often has undesirable side effects both on the patient's body and on the operating person himself; on the other hand, the excellent results obtained by surgeons who do not use the antiseptic method and observe only cleanliness have compelled operators with well-established clinics to replace antiseptics with asepsis more and more.

Rest and Exercise in the Treatment of Nervous and Mental Diseases

1896 ◽  
Vol 42 (177) ◽  
pp. 261-267
Author(s):  
L. Meyer
Keyword(s):  
Great Britain ◽  
Medical Treatment ◽  
Theory And Practice ◽  
The Other ◽  
Other Hand ◽  
Mental Diseases ◽  
Rest And Exercise

More than a generation ago (in 1860), in Hamburg, I made my first experiment in treating patients suffering from recent insanity, especially the excited, in bed. This treatment, continued in the Göttingen Asylum, forms a prominent part of my system. It may therefore be inferred that the first experiments were confirmed by many excellent results; while, on the other hand, there have not been wanting occasional failures, which, indeed, attend on every method of medical treatment. I am glad to have an opportunity of laying my experience in this matter before the Medico-Psychological Association. My contribution may be taken as a small tribute in recognition of all I have learned from Great Britain throughout my psychiatric career, both in theory and practice.

Is gabapentin effective for preventing delayed nausea and vomiting (NV) after moderately and highly emetogenic chemotherapy (CT)?

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 18575-18575
Author(s):  
A. Menendez-Leal ◽  
C. Quijano ◽  
A. G. Menendez-Rivera
Keyword(s):  
Side Effects ◽  
Primary Endpoint ◽  
Emetogenic Chemotherapy ◽  
The Other ◽  
Nausea And Vomiting ◽  
Highly Emetogenic Chemotherapy ◽  
Good Tolerability ◽  
Other Hand ◽  
Delayed Nausea ◽  
Financial Relationships

18575 Background: Following previous institutional observations,this protocol was designed to evaluate the efficacy of Gabapentin in the prophylaxis of delayed CT induced NV. Methods: The main elegibility criteria was moderate and severe NV on previous CT cycles.Gabapentin 300 mg caps. was given as follows: One capsule day -2, two capsules day -1 and one capsule tid from days 1 to 5. 24 pats. were evaluated; 22 (92%) female, 2 (8%) male.CT included Doxorubicin/Ciclofosfamide 15 (62.5%), Cis-Platin 5 (21%), Other regimens 4 (17%). Previous prophylaxis for all pats. included a 5-HT3 Antagonist plus Dexametasone. Pats. were instructed to complete a two-page Questionaire: On page 1 pats. indicated the intensity of nausea according a scale shown there. On page two they indicated the number of vomits they had.This was made three times daily for five days. The primary endpoint was reduction of NV aftyer CT. Results: The reduction observed in the number of vomits was as follows: Number of pats. that experienced 0 Vomits: day 1 (CT): 14 (58.3%); day 2: 18 (75%); day 3: 20 (83.3%); day 4: 18 (75%); day 5: 22 (91.7%). On the other hand, pats. that did not respond and had three or more vomits daily: day 1: 5 (20.8%); day 2: 2 (8.3%); day 3: 1 (4.2%); day 4: 3 (12.5%); day 5: 2 (8.3%).Most pats. experienced a decrease in the intensity of nausea as well. No significant side effects were seen. Conclusions: Gabapentin seems to have some efficacy preventing delayed NV after moderately and highly emetogenic CT. These results together with it’s possible effect on acute NV and good tolerability warrant further studies. No significant financial relationships to disclose.

The Initiation of Long-Term Pharmacotherapy in Schizophrenia: Dosage and Side Effect Comparisons Between Oral and Depot Fluphenazine*

1976 ◽  
Vol 09 (04) ◽  
pp. 159-169 ◽  
Author(s):  
Nina R. Schooler ◽  
J. Levine ◽  
Keyword(s):  
Side Effects ◽  
Side Effect ◽  
Dosage Forms ◽  
The Other ◽  
Oral Drug ◽  
Double Blind ◽  
Moderate Severity ◽  
Treatment Groups ◽  
The Relationship

SummaryThis report focuses on two comparisons between oral and depot fluphenazine specifically FPZ decanoate: 1) can equivalent dosages for the two drugs be established and do these equivalencies change over six months of treatment; 2) what are the side effects seen with the two drugs during the early weeks of administration.Patients in the study receive either oral or depot FPZ as the active treatment but in order to preserve double blind conditions, they are also given the other treatment in placebo form. No dosage equivalence is established by the protocol, however, if dosage is adjusted, both forms must be changed and in the same direction. During the first weeks of treatment there is a linear relationship between the two dosage forms but a range of relatively low dosages of the oral compound (5-20 mg) is associated with a single dose (25 mg/q 3 weeks) of FPZ decanoate. At higher dosages of the oral drug the relationship is linear. Side effects of some kind are noted in over 60 percent of patients in both treatment groups after four weeks of treatment, while symptoms of at least moderate severity occur in almost 40 percent. Only symptoms involving the extrapyramidal system and sleep disturbance are observed in more than 20 percent of the patients. Benztropine was prescribed only if needed and was administered to 65 percent of patients. In general, those receiving benztropine had more side effects than those who did not. These differences reached significance for extrapyramidal symptoms and depression.Based on these data, we conclude that at the dosages used in this study there are no side effect differences between these two forms of fluphenazine in the early weeks of administration. Dosage equivalence between the two drugs can be set within the range of 5- 60 mg/day oral and 12.5-100 mg/three weeks depot.

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