scholarly journals WHAT EVERY PSYCHOLOGIST AND PSYCHOTHERAPIST SHOULD KNOW ABOUT THE PLACEBO AND NOCEBO EFFECT

2021 ◽  
pp. 68-82
Author(s):  
Salvatore Giacomuzzi ◽  
Markus Ertl ◽  
Natalia Barinova ◽  
Klaus Garber ◽  
Alexander Kocharian
Keyword(s):  
Clinical Trials ◽  
Adverse Effects ◽  
Healthcare Professionals ◽  
Scientific Literature ◽  
Nocebo Effect ◽  
Positive Interaction ◽  
Ongoing Debate ◽  
Scientific Terminology ◽  
Medical Terms ◽  
Nocebo Effects

Purpose. Only a few medical terms are used as often, even in a metaphorically way, as the words placebo and nocebo. Almost any psychologist and psychotherapist think he/she knows well what by a placebo or nocebo is understood, but usually without really being able to explain it exactly and how it works. In addition, most psychologists and psychotherapists immediately think of clinical trials. However, many things are attributed to the placebo or nocebo effect that does not really fall under this concept in terms of a strict scientific terminology. Therefore, the following article summarizes the ongoing debate on placebo/nocebo effects by citing the current scientific literature. Methods. To realize the purpose of the study, we used the methods of theoretical scientific research. Results. In summary patients are more prone to develop nocebo effects are those with alternative or negative healthcare beliefs or experiences or unrealistic perceptions about treatment; managing these factors is a core strategy to counteract the nocebo effect. Conclusions. Healthcare professionals can help to minimise the influence of the nocebo effect by considering how information about treatments, including benefits and adverse effects, is framed and communicated. Establishing a positive interaction from the start and involving patients in decisions about their treatment and ensuring they understand the cause of their illness and what they can do to manage their symptoms is likely to lead to better treatment outcomes.

scholarly journals Unethical informed consent caused by overlooking poorly measured nocebo effects

2020 ◽  
pp. medethics-2019-105903
Author(s):  
Jeremy Howick
Keyword(s):  
Clinical Trials ◽  
Clinical Practice ◽  
Informed Consent ◽  
Natural History ◽  
Adverse Events ◽  
Placebo Effect ◽  
Nocebo Effect ◽  
Control Groups ◽  
Nocebo Effects ◽  
Negative Outcome

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.

scholarly journals Placebo and nocebo effects in the neurological practice

2015 ◽  
Vol 73 (1) ◽  
pp. 58-63 ◽  
Author(s):  
Caroline Bittar ◽  
Osvaldo J.M. Nascimento
Keyword(s):  
Clinical Trials ◽  
Clinical Practice ◽  
Gold Standard ◽  
Neurological Diseases ◽  
Nocebo Effect ◽  
Double Blind ◽  
Positive Effects ◽  
Specific Effects ◽  
Randomized Clinical Study ◽  
Nocebo Effects

Knowledge of placebo and nocebo effects is essential to identify their influence on the results in clinical practice and clinical trials, and thereby properly interpret their results. It is known that the gold standard of clinical trials research is the double-blind, placebo-controlled, randomized clinical study. The objective of this review is to distinguish specific from non-specific effects, so that the presence of positive effects in the group that received placebo (placebo effect) and the presence of adverse effects in the group receiving placebo (nocebo effect) lead to confounding in interpreting the results. Placebo and nocebo effects have been considered in neurological diseases such as depression, pain, headache, multiple sclerosis, epilepsy. As placebo and nocebo effects are also present in clinical practice, the purpose of this review is to draw attention to their influence on neurological practice, calling attention to the development of measures that can minimize them.

scholarly journals Nocebo effects and participant information leaflets: evaluating information provided on adverse effects in UK clinical trials

Trials ◽  
2020 ◽  
Vol 21 (1) ◽  
Author(s):  
Nigel Kirby ◽  
Victoria Shepherd ◽  
Jeremey Howick ◽  
Sophie Betteridge ◽  
Kerenza Hood
Keyword(s):  
Clinical Trials ◽  
Adverse Effects ◽  
Information Leaflets ◽  
Nocebo Effects ◽  
Participant Information

scholarly journals European Headache Federation recommendations for placebo and nocebo terminology

2020 ◽  
Vol 21 (1) ◽  
Author(s):  
Dimos D. Mitsikostas ◽  
◽  
Charlotte Blease ◽  
Elisa Carlino ◽  
Luana Colloca ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Working Group ◽  
Medical Condition ◽  
Placebo Response ◽  
Placebo Administration ◽  
Nocebo Effect ◽  
Nocebo Effects ◽  
Final Agreement ◽  
European Headache Federation ◽  
Term Response

Abstract Background and aim Despite recent publications, practitioners remain unfamiliar with the current terminology related to the placebo and nocebo phenomena observed in clinical trials and practice, nor with the factors that modulate them. To cover the gap, the European Headache Federation appointed a panel of experts to clarify the terms associated with the use of placebo in clinical trials. Methods The working group identified relevant questions and agreed upon recommendations. Because no data were required to answer the questions, the GRADE approach was not applicable, and thus only expert opinion was provided according to an amended Delphi method. The initial 12 topics for discussion were revised in the opinion of the majority of the panelists, and after a total of 6 rounds of negotiations, the final agreement is presented. Results/recommendations Two primary and mechanism-based recommendations are provided for the results of clinical trials: [1] to distinguish the placebo or nocebo response from the placebo or nocebo effect; and [2] for any favorable outcome observed after placebo administration, the term “placebo response” should be used, and for any unfavorable outcome recorded after placebo administration, the term “nocebo response” should be used (12 out of 17 panelists agreed, 70.6% agreement). The placebo or nocebo responses are attributed to a set of factors including those that are related to the medical condition (e.g. natural history, random comorbidities, etc.), along with idiosyncratic ones, in which the placebo or nocebo effects are attributed to idiosyncratic, or nonspecific mechanisms, exclusively (e.g. expectation, conditioning, observational learning etc.). To help investigators and practitioners, the panel summarized a list of environmental factors and idiosyncratic dynamics modulating placebo and nocebo effects. Some of them are modifiable, and investigators or physicians need to know about them in order to modify these factors appropriately to improve treatment. One secondary recommendation addresses the use of the terms “placebo” and “nocebo” (“placebos” and “nocebos” in plural), which refer to the triggers of the placebo/nocebo effects or responses, respectively, and which are inert agents or interventions that should not be confused with the placebo/nocebo responses or effects themselves (all panelists agreed, 100% agreement). Conclusion The working group recommends distinguishing the term response from effect to describe health changes from before to after placebo application and to distinguish the terms placebo(s) or nocebo(s) from the health consequences that they cause (placebo/nocebo responses or effects).

Potential of Mirabegron and its Extended-release Formulations for the Treatment of Overactive Bladder Syndrome

2020 ◽  
Vol 21 (2) ◽  
pp. 79-88 ◽  
Author(s):  
Pankaj Mandpe ◽  
Bala Prabhakar ◽  
Pravin Shende
Keyword(s):  
Clinical Trials ◽  
Overactive Bladder ◽  
Adverse Effects ◽  
Symptomatic Relief ◽  
Phase Iii ◽  
Overactive Bladder Syndrome ◽  
Modified Release ◽  
Blurred Vision ◽  
Antimuscarinic Drugs ◽  
Tablet Dosage

Background: Overactive bladder syndrome is a broadly occurring urological disorder with a distressing impact on the quality of life. The commonly used antimuscarinic drugs show poor patient compliance because of unsatisfactory potency, tolerability and high occurrence of adverse effects such as dry mouth, blurred vision, constipation, dizziness etc. Mirabegron is the first approved β3-adrenoreceptor agonist, used as mono or in combination therapies for overactive bladder syndrome. Objective: The present review provides an insight into the mechanism, pharmacokinetics, toxicokinetics, clinical trials and the development of various conventional and modified-release dosage forms of mirabegron for the treatment of overactive bladder syndrome. Results: The clinical trials of phase II and phase III of mirabegron demonstrated symptomatic relief from the overactive bladder without disturbing the micturition cycle. To date, mirabegron showed promising results for safety, tolerability and efficacy in patients with overactive bladder syndrome. The modified-release tablet dosage form of mirabegron appear to be a proficient and suitable replacement for antimuscarinics and revealed the tremendous potential to overcome the adverse effects of conventional antimuscarinic drugs like Oxybutyline chloride ER, Detrol LA, VESIcare, etc. Conclusion: Mirabegron shows a distinct mode of action, i.e., targeting β3-adrenoreceptors and improving bladder storage without altering void contractions. The limited side effects, high safety, efficacy and tolerability of mirabegron present an adequate substitute to antimuscarinics. However, long-term analysis and clinical studies are prerequisites for assessing the safety, tolerability and efficacy profile of mirabegron.

Prebiotics and Probiotics in Inflammatory Bowel Disease: Where are we now and where are we going?

2020 ◽  
Vol 15 (3) ◽  
pp. 216-233 ◽  
Author(s):  
Maliha Naseer ◽  
Shiva Poola ◽  
Syed Ali ◽  
Sami Samiullah ◽  
Veysel Tahan
Keyword(s):  
Ulcerative Colitis ◽  
Inflammatory Bowel Disease ◽  
Clinical Trials ◽  
Crohn’S Disease ◽  
Crohn's Disease ◽  
Adverse Effects ◽  
Bowel Disease ◽  
Relapse Prevention ◽  
Remission Induction ◽  
Inflammatory Bowel

The incidence, prevalence, and cost of care associated with diagnosis and management of inflammatory bowel disease are on the rise. The role of gut microbiota in the causation of Crohn's disease and ulcerative colitis has not been established yet. Nevertheless, several animal models and human studies point towards the association. Targeting intestinal dysbiosis for remission induction, maintenance, and relapse prevention is an attractive treatment approach with minimal adverse effects. However, the data is still conflicting. The purpose of this article is to provide the most comprehensive and updated review on the utility of prebiotics and probiotics in the management of active Crohn’s disease and ulcerative colitis/pouchitis and their role in the remission induction, maintenance, and relapse prevention. A thorough literature review was performed on PubMed, Ovid Medline, and EMBASE using the terms “prebiotics AND ulcerative colitis”, “probiotics AND ulcerative colitis”, “prebiotics AND Crohn's disease”, “probiotics AND Crohn's disease”, “probiotics AND acute pouchitis”, “probiotics AND chronic pouchitis” and “prebiotics AND pouchitis”. Observational studies and clinical trials conducted on humans and published in the English language were included. A total of 71 clinical trials evaluating the utility of prebiotics and probiotics in the management of inflammatory bowel disease were reviewed and the findings were summarized. Most of these studies on probiotics evaluated lactobacillus, De Simone Formulation or Escherichia coli Nissle 1917 and there is some evidence supporting these agents for induction and maintenance of remission in ulcerative colitis and prevention of pouchitis relapse with minimal adverse effects. The efficacy of prebiotics such as fructooligosaccharides and Plantago ovata seeds in ulcerative colitis are inconclusive and the data regarding the utility of prebiotics in pouchitis is limited. The results of the clinical trials for remission induction and maintenance in active Crohn's disease or post-operative relapse with probiotics and prebiotics are inadequate and not very convincing. Prebiotics and probiotics are safe, effective and have great therapeutic potential. However, better designed clinical trials in the multicenter setting with a large sample and long duration of intervention are needed to identify the specific strain or combination of probiotics and prebiotics which will be more beneficial and effective in patients with inflammatory bowel disease.

The Use of Methotrexate in Rheumatoid Arthritis

1985 ◽  
Vol 19 (5) ◽  
pp. 349-358 ◽  
Author(s):  
Peter W. Letendre ◽  
Douglas J. DeJong ◽  
Donald R. Miller
Keyword(s):  
Rheumatoid Arthritis ◽  
Clinical Trials ◽  
Folic Acid ◽  
Side Effects ◽  
Adverse Effects ◽  
Systemic Administration ◽  
Refractory Disease ◽  
Controlled Clinical Trials ◽  
Folic Acid Antagonist ◽  
Acid Antagonist

The use of methotrexate in rheumatoid arthritis is reviewed. Methotrexate, a folic acid antagonist, is sometimes employed in an attempt to symptomatically control patients whose disease does not respond adequately to conventional therapies. Systemic administration of 7.5–15 mg/wk in a “pulse” fashion appears to be effective without precipitating severe adverse effects. However, concern over potentially serious side effects and a lack of well-controlled clinical trials have limited its use to severe, refractory disease. Further studies are needed before its role in rheumatoid arthritis can justifiably be expanded.

scholarly journals ANCA Status or Clinical Phenotype — What Counts More?

2021 ◽  
Vol 23 (6) ◽  
Author(s):  
Martin Windpessl ◽  
Erica L. Bettac ◽  
Philipp Gauckler ◽  
Jae Il Shin ◽  
Duvuru Geetha ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Granulomatosis With Polyangiitis ◽  
Clinical Phenotype ◽  
Antineutrophil Cytoplasmic Antibody ◽  
Cardiovascular Death ◽  
Genetic Associations ◽  
Ongoing Debate ◽  
The Past ◽  
Anca Associated Vasculitis

Abstract Purpose of Review There is ongoing debate concerning the classification of antineutrophil cytoplasmic antibody (ANCA)-associated vasculitis. That is, whether classification should be based on the serotype (proteinase 3 (PR3)- or myeloperoxidase (MPO)-ANCA) or on the clinical phenotype (granulomatosis with polyangiitis (GPA) or microscopic polyangiitis (MPA)). To add clarity, this review focused on integration of the most recent literature. Recent Findings Large clinical trials have provided evidence that a serology-based risk assessment for relapses is more predictive than distinction based on the phenotype. Research conducted in the past decade indicated that a serology-based approach more closely resembles the genetic associations, the clinical presentation (i.e., lung involvement), biomarker biology, treatment response, and is also predicting comorbidities (such as cardiovascular death). Summary Our review highlights that a serology-based approach could replace a phenotype-based approach to classify ANCA-associated vasculitides. In future, clinical trials and observational studies will presumably focus on this distinction and, as such, translate into a “personalized medicine.”

scholarly journals Understanding the Links between Inferring Mental States, Empathy, and Burnout in Medical Contexts

Healthcare ◽  
2021 ◽  
Vol 9 (2) ◽  
pp. 158
Author(s):  
Naira Delgado ◽  
Helena Bonache ◽  
Moisés Betancort ◽  
Yurena Morera ◽  
Lasana T. Harris
Keyword(s):  
Adverse Effects ◽  
Patient Care ◽  
Emotional Exhaustion ◽  
Mental State ◽  
Perspective Taking ◽  
Healthcare Professionals ◽  
Mental States ◽  
Empathic Concern ◽  
Personal Accomplishment ◽  
Personal Distress

It is generally accepted that empathy should be the basis of patient care. However, this ideal may be unrealistic if healthcare professionals suffer adverse effects when engaging in empathy. The aim of this study is to explore the effect of inferring mental states and different components of empathy (perspective-taking; empathic concern; personal distress) in burnout dimensions (emotional exhaustion; depersonalization; personal accomplishment). A total of 184 healthcare professionals participated in the study (23% male, Mage = 44.60; SD = 10.46). We measured participants’ empathy, the inference of mental states of patients, and burnout. Correlation analyses showed that inferring mental states was positively associated with perspective-taking and with empathic concern, but uncorrelated with personal distress. Furthermore, emotional exhaustion was related to greater levels of personal distress and greater levels of inferences of mental states. Depersonalization was associated with greater levels of personal distress and lower levels of empathic concern. Personal accomplishment was associated with the inference of mental states in patients, lower levels of personal distress, and perspective-taking. These results provide a better understanding of how different components of empathy and mental state inferences may preserve or promote healthcare professionals’ burnout.

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