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Archivos Argentinos de Pediatria Dec 2020
Topics: Ethics, Medical; Humans; Placebo Effect
PubMed: 33231040
DOI: 10.5546/aap.2020.eng.370 -
Annual Review of Pharmacology and... Jan 2019Pharmacological strategies for pain management have primarily focused on dampening ascending neurotransmission and on opioid receptor-mediated therapies. Little is known... (Review)
Review
Pharmacological strategies for pain management have primarily focused on dampening ascending neurotransmission and on opioid receptor-mediated therapies. Little is known about the contribution of endogenous descending modulatory systems to clinical pain outcomes and why some patients are mildly affected while others suffer debilitating pain-induced dysfunctions. Placebo effects that arise from patients' positive expectancies and the underlying endogenous modulatory mechanisms may in part account for the variability in pain experience and severity, adherence to treatment, distinct coping strategies, and chronicity. Expectancy-induced analgesia and placebo effects in general have emerged as useful models to assess individual endogenous pain modulatory systems. Different systems and mechanisms trigger placebo effects that highly impact pain processing, clinical outcomes, and sense of well-being. This review illustrates critical elements of placebo mechanisms that inform the methodology of clinical trials, the discovery of new therapeutic targets, and the advancement of personalized pain management.
Topics: Animals; Clinical Trials as Topic; Humans; Pain; Pain Management; Placebo Effect; Receptors, Opioid
PubMed: 30216744
DOI: 10.1146/annurev-pharmtox-010818-021542 -
Trials Jul 2021Contextual effects (i.e., placebo response) refer to all health changes resulting from administering an apparently inactive treatment. In a randomized clinical trial... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Contextual effects (i.e., placebo response) refer to all health changes resulting from administering an apparently inactive treatment. In a randomized clinical trial (RCT), the overall treatment effect (i.e., the post-treatment effect in the intervention group) can be regarded as the true effect of the intervention plus the impact of contextual effects. This meta-research was conducted to examine the average proportion of the overall treatment effect attributable to contextual effects in RCTs across clinical conditions and treatments and explore whether it varies with trial contextual factors.
METHODS
Data was extracted from trials included in the main meta-analysis from the latest update of the Cochrane review on "Placebo interventions for all clinical conditions" (searched from 1966 to March 2008). Only RCTs reported in English having an experimental intervention group, a placebo comparator group, and a no-treatment control group were eligible.
RESULTS
In total, 186 trials (16,655 patients) were included. On average, 54% (0.54, 95%CI 0.46 to 0.64) of the overall treatment effect was attributable to contextual effects. The contextual effects were higher for trials with blinded outcome assessor and concealed allocation. The contextual effects appeared to increase proportional to the placebo effect, lower mean age, and proportion of females.
CONCLUSION
Approximately half of the overall treatment effect in RCTs seems attributable to contextual effects rather than to the specific effect of treatments. As the study did not include all important contextual factors (e.g., patient-provider interaction), the true proportion of contextual effects could differ from the study's results. However, contextual effects should be considered when assessing treatment effects in clinical practice.
TRIAL REGISTRATION
PROSPERO CRD42019130257 . Registered on April 19, 2019.
Topics: Female; Humans; Placebo Effect; Randomized Controlled Trials as Topic
PubMed: 34311793
DOI: 10.1186/s13063-021-05454-8 -
International Review of Neurobiology 2018Placebo and nocebo effects form part of all therapeutic environments and play a significant role in the effectiveness of treatment outcomes. Patient expectancies drive... (Review)
Review
INTRODUCTION
Placebo and nocebo effects form part of all therapeutic environments and play a significant role in the effectiveness of treatment outcomes. Patient expectancies drive these phenomena, which can be shaped through contextual factors including verbal suggestions, conditioning, and social observation.
OBJECTIVES
This review seeks to identify the biopsychosocial factors of the patient-practitioner interaction that play a role in the development of placebo and nocebo effects, as well as the anthropological elements of the biodynamic process of relating that are meaningful in the development of expectancies.
METHODS
We conducted a narrative review of frameworks of the placebo and nocebo effect, including the impact of expectancies and interpersonal relationships in the context of healing and the clinical setting.
RESULTS
Expectancies leading to placebo and nocebo effects can be modified by macro and micro factors, such as culture and society, as well as individual psychobiological traits, respectively. The developmental sociobiological adaptations that form and consolidate mindsets and meaningful contexts play an important role in shaping patient expectancies, as well as patients' conscious and subconscious reactions to signs and actions taking place within the clinical environment. Practitioner characteristics, like empathy, friendliness, and competence, favor the formation of positive expectancies. Caring and warm patient-practitioner interactions can enhance the therapeutic value of clinical encounters when patients' positive expectancies are actively encouraged and engaged.
CONCLUSION
A patient-centered approach rooted in demonstrating care and empathy can positively enhance a patient's experience within the clinical environment and activate psychosociobiological adaptations associated with the placebo phenomenon. Pain patients could particularly benefit from non-invasive approaches for improving treatment effectiveness and quality-of-life.
Topics: Anthropology; Emotions; Humans; Nocebo Effect; Physician-Patient Relations; Placebos; Psychology; Treatment Outcome
PubMed: 30146048
DOI: 10.1016/bs.irn.2018.07.033 -
Musculoskeletal Science & Practice Dec 2022While the placebo effect is increasingly recognised as a contributor to treatment effects in clinical practice, the nocebo and other undesirable effects are less well... (Review)
Review
INTRODUCTION
While the placebo effect is increasingly recognised as a contributor to treatment effects in clinical practice, the nocebo and other undesirable effects are less well explored and likely underestimated. In the chiropractic, osteopathy and physiotherapy professions, some aspects of historical models of care may arguably increase the risk of nocebo effects.
PURPOSE
In this masterclass article, clinicians, researchers, and educators are invited to reflect on such possibilities, in an attempt to stimulate research and raise awareness for the mitigation of such undesirable effects.
IMPLICATIONS
This masterclass briefly introduces the nocebo effect and its underlying mechanisms. It then traces the historical development of chiropractic, osteopathy, and physiotherapy, arguing that there was and continues to be an excessive focus on the patient's body. Next, aspects of clinical practice, including communication, the therapeutic relationship, clinical rituals, and the wider social and economic context of practice are examined for their potential to generate nocebo and other undesirable effects. To aid reflection, a model to reflect on clinical practice and individual professions through the 'prism' of nocebo and other undesirable effects is introduced and illustrated. Finally, steps are proposed for how researchers, educators, and practitioners can maximise positive and minimise negative clinical context.
Topics: Humans; Nocebo Effect; Placebo Effect; Physical Therapy Modalities; Communication
PubMed: 36368170
DOI: 10.1016/j.msksp.2022.102677 -
Complementary Therapies in Clinical... Aug 2022Reflexology is a complementary therapy focusing mainly on the application of pressure on the feet, hands and ears. A small but growing evidence base suggests that...
Reflexology is a complementary therapy focusing mainly on the application of pressure on the feet, hands and ears. A small but growing evidence base suggests that positive outcomes can be gained in the management and improvement of symptoms across a range of conditions. Biological plausibility is a key concept in the determination of the usefulness of therapies. Research which tests for safety and efficacy alongside the underpinning mechanism of action are therefore important. This paper explores the potential mechanism of action for the outcomes associated with reflexology treatment as reflected in the current evidence. The influences of therapeutic touch, relaxation, placebo effects and the similarities with other therapeutic methods of structural manipulation are considered. The lack of clarity around the precise definition of reflexology and the challenges of researching the therapy as a treatment tailored to individual need are discussed. A deeper understanding of the mechanism of action for reflexology may help to further develop research into safety and efficacy. Such an understanding may lead to the integration of knowledge which may provide both symptomatic support and longer term preventative health benefits.
Topics: Complementary Therapies; Ear; Foot; Hand; Humans; Massage; Musculoskeletal Manipulations; Placebo Effect; Relaxation Therapy; Therapeutic Touch
PubMed: 35613519
DOI: 10.1016/j.ctcp.2022.101606 -
Psychotherapy and Psychosomatics 2018Placebo and nocebo effects occur in clinical or laboratory medical contexts after administration of an inert treatment or as part of active treatments and are due to...
BACKGROUND
Placebo and nocebo effects occur in clinical or laboratory medical contexts after administration of an inert treatment or as part of active treatments and are due to psychobiological mechanisms such as expectancies of the patient. Placebo and nocebo studies have evolved from predominantly methodological research into a far-reaching interdisciplinary field that is unravelling the neurobiological, behavioural and clinical underpinnings of these phenomena in a broad variety of medical conditions. As a consequence, there is an increasing demand from health professionals to develop expert recommendations about evidence-based and ethical use of placebo and nocebo effects for clinical practice.
METHODS
A survey and interdisciplinary expert meeting by invitation was organized as part of the 1st Society for Interdisciplinary Placebo Studies (SIPS) conference in 2017. Twenty-nine internationally recognized placebo researchers participated.
RESULTS
There was consensus that maximizing placebo effects and minimizing nocebo effects should lead to better treatment outcomes with fewer side effects. Experts particularly agreed on the importance of informing patients about placebo and nocebo effects and training health professionals in patient-clinician communication to maximize placebo and minimize nocebo effects.
CONCLUSIONS
The current paper forms a first step towards developing evidence-based and ethical recommendations about the implications of placebo and nocebo research for medical practice, based on the current state of evidence and the consensus of experts. Future research might focus on how to implement these recommendations, including how to optimize conditions for educating patients about placebo and nocebo effects and providing training for the implementation in clinical practice.
Topics: Consensus; Drug-Related Side Effects and Adverse Reactions; Evidence-Based Practice; Humans; Nocebo Effect; Physician-Patient Relations; Placebo Effect
PubMed: 29895014
DOI: 10.1159/000490354 -
BMC Musculoskeletal Disorders Jan 2018Placebo and nocebo effects are embodied psycho-neurobiological responses capable of modulating pain and producing changes at different neurobiological, body at... (Review)
Review
Placebo and nocebo effects are embodied psycho-neurobiological responses capable of modulating pain and producing changes at different neurobiological, body at perceptual and cognitive levels. These modifications are triggered by different contextual factors (CFs) presented in the therapeutic encounter between patient and healthcare providers, such as healing rituals and signs. The CFs directly impact on the quality of the therapeutic outcome: a positive context, that is a context characterized by the presence of positive CFs, can reduce pain by producing placebo effects, while a negative context, characterized by the presence of negative CFs, can aggravate pain by creating nocebo effects. Despite the increasing interest about this topic; the detailed study of CFs as triggers of placebo and nocebo effects is still lacked in the management of musculoskeletal pain.Increasing evidence suggest a relevant role of CFs in musculoskeletal pain management. CFs are a complex sets of internal, external or relational elements encompassing: patient's expectation, history, baseline characteristics; clinician's behavior, belief, verbal suggestions and therapeutic touch; positive therapeutic encounter, patient-centered approach and social learning; overt therapy, posology of intervention, modality of treatment administration; marketing features of treatment and health care setting. Different explanatory models such as classical conditioning and expectancy can explain how CFs trigger placebo and nocebo effects. CFs act through specific neural networks and neurotransmitters that were described as mediators of placebo and nocebo effects.Available findings suggest a relevant clinical role and impact of CFs. They should be integrated in the clinical reasoning to increase the number of treatment solutions, boosts their efficacy and improve the quality of the decision-making. From a clinical perspective, the mindful manipulation of CFs represents a useful opportunity to enrich a well-established therapy in therapeutic setting within the ethical border. From a translational perspective, there is a strong need of research studies on CFs close to routine and real-world clinical practice in order to underline the uncertainty of therapy action and help clinicians to implement knowledge in daily practice.
Topics: Clinical Decision-Making; Humans; Musculoskeletal Pain; Nocebo Effect; Pain Management; Physician-Patient Relations; Placebo Effect
PubMed: 29357856
DOI: 10.1186/s12891-018-1943-8 -
Annual Review of Pharmacology and... Jan 2024Adverse nocebo responses can cause harm to patients and interfere with treatment adherence and effects in both clinic practice and clinical trials. Nocebo responses... (Review)
Review
Adverse nocebo responses can cause harm to patients and interfere with treatment adherence and effects in both clinic practice and clinical trials. Nocebo responses refer to negative outcomes to active medical treatments in clinical trials or practice that cannot be explained by the treatment's pharmacologic effects. Negative expectancies and nocebo effects are less known than placebo responses. Nocebo effects can be triggered by verbal suggestions, prior negative experiences, observation of others experiencing negative outcomes, and other contextual and environmental factors. As research advances over the years, mechanistic knowledge is accumulating on the neurobiological mechanisms of nocebo effects. This review summarizes studies on different facets of nocebo effects and responses and discusses clinical implications, ethical considerations, and future directions.
Topics: Humans; Nocebo Effect; Placebo Effect
PubMed: 37585661
DOI: 10.1146/annurev-pharmtox-022723-112425 -
International Review of Neurobiology 2018
Topics: Animals; Biomedical Research; Humans; Placebo Effect; Placebos
PubMed: 29681338
DOI: 10.1016/S0074-7742(18)30027-8