Teoría de la complejidad en la atención del paciente con dolor musculoesquelético / Complexity theory in the management of patients with musculoskeletal pain

Los sistemas no lineales no son susceptibles de ser investigados con métodos reduccionistas. En este sentido, la teoría de la complejidad ofrece un enfoque alternativo para cuantificar la importancia de los factores contextuales en el paciente con dolor musculoesquelético. El resultado del uso positivo (placebo) o negativo (nocebo) de factores contextuales en el entorno terapéutico, podría ser responsable de gran parte de un componente inespecífico en la eficacia del tratamiento, afectando directamente la calidad de los resultados relacionados con la salud del paciente (por ejemplo, dolor, funcionalidad o satisfacción). En los últimos años, se ha incrementado la comprensión del valor de estos efectos. A pesar del creciente interés, el conocimiento y el reconocimiento de los efectos terapéuticos, continúan siendo limitados y heterogéneos entre los fisioterapeutas, lo cual reduce su valor traslacional en el campo de la fisioterapia. El propósito de este estudio es presentar el abordaje el paciente con dolor musculoesquelético desde la perspectiva la teoría de la complejidad.

Nonlinear systems are not susceptible to research with a reductionist approach. In this sense, the complexity theory provides an alternative approach to quantify the importance of contextual factors in patients with musculoskeletal pain. The use of positive (placebo) or negative (nocebo) contextual factors in the therapeutic setting could largely account for the non-specific component of treatment efficacy, directly affecting the quality of patients' health-related outcomes (e.g., pain, disability, or satisfaction). In recent years, there has been a better understanding of the effects of contextual factors. However, the knowledge and awareness of them is limited and heterogeneous among physical therapists, reducing their translational value in the field of physiotherapy. The purpose of this essay is to describe the management of patients with musculoskeletal pain from the complexity theory perspective.

Complexity theory in the management of patients with pain

Nonlinear systems are not susceptible to being investigated with reductionist methods. In this sense, complexity theory offers an alternative approach to quantify the importance of contextual factors (CFs) in the patient with pain. The result of the positive (placebo) or negative (nocebo) use of CFs in the therapeutic setting could be responsible for a large part of a non-specific component of the efficacy of the treatment, directly affecting the quality of the results related to the patient's health (for example, pain, disability, or satisfaction). In recent years, understanding of the value of these effects has increased. Despite growing interest, knowledge, and awareness of them is currently limited and heterogeneous among health professionals, reducing their translational value in the field of health.Keywords: complexity, contextual factors, pain, health professionals, placebo, nocebo.

Los sistemas no lineales no son susceptibles de ser investigados con métodos reduccionistas. En este sentido, la teoría de la complejidad ofrece un enfoque alternativo para cuantificar la importancia de los factores contextuales (FCs) en el paciente con dolor. El resultado del uso positivo (placebo) o negativo (nocebo) de FCs en el tratamiento podría ser responsable de gran parte de un componente no específico de la eficacia del tratamiento, afectando directamente la calidad de los resultados relacionados con la salud del paciente (por ejemplo, dolor, funcionalidad o satisfacción).En los últimos años se ha incrementado la comprensión del valor de estos efectos. A pesar del creciente interés, el conocimiento y la conciencia de ellos es actualmente limitado y heterogéneo entre profesionales de la salud, lo que reduce su valor traslacional en el campo de la salud.Palabras clave: complejidad; factores contextuales; profesionales de la salud; dolor; placebo; nocebo.

Nocebo effect in health communication: how to minimize it? / Efeito nocebo na comunicação em saúde: como minimizá-lo?

ABSTRACT Purpose: to describe the strategies used to minimize the nocebo effect in health communication. Methods: an integrative review of the literature. The keywords "nocebo effect" and "health communication" and their combinations were used in English, Portuguese, and Spanish to search publications from 2011 to 2021 in MEDLINE, Latin American and Caribbean Health Sciences Literature (LILACS), Cochrane Library, EMBASE, and Web of Science/ISI. The following research question was used: "Which strategies have been used to minimize the nocebo effect in health communication?". Literature Review: altogether, 77 articles were found, although only six met the inclusion criteria and comprised the review sample. Their year of publication ranged from 2015 to 2021. Positive framing, assertive communication, and contextual factors were the strategies used to minimize the nocebo effect. Conclusion: the strategies used to minimize the nocebo effect were contextual factors, motivational talk, positive framing, assertive communication, and empathetic communication. These communication techniques are seemingly effective, though still little known by health professionals. This knowledge is important as it helps develop communicative skills aiming at humanized patient care.

RESUMO Objetivo: descrever as estratégias para minimizar o efeito nocebo na comunicação em saúde. Métodos: trata-se de uma revisão integrativa da literatura. Os descritores utilizados foram: "Efeito nocebo" e "comunicação em saúde", em inglês, português e espanhol e suas combinações, no período de 2011 a 2021, nas bases de dados da Medline, Literatura Latino-Americana e do Caribe em Ciências da Saúde (LILACS), Cochrane Library, Embase e Web of Science/ISI. A pergunta de investigação para esse estudo foi: Quais as estratégias utilizadas para minimizar o efeito nocebo na comunicação em saúde? Revisão da Literatura: foram encontrados 77 artigos. Apenas seis preencheram os critérios de inclusão e compuseram a amostra da revisão. Os anos de publicação dos artigos variaram entre 2015 e 2021. As estratégias definidas para minimizar o efeito nocebo foram: enquadramento positivo, comunicação assertiva e utilização de fatores contextuais. Conclusão: as estratégias encontradas para minimizar o efeito nocebo foram fatores contextuais, conversa motivacional, enquadramento positivo, comunicação assertiva e comunicação empática. Essas técnicas de comunicação parecem ser efetivas, mas ainda são pouco conhecidas pelos profissionais em saúde. Esse conhecimento se faz importante, pois auxilia no desenvolvimento de habilidades comunicativas que visam à humanização do cuidado ao paciente.

Nocebo/Placebo Effects in Dental Practice: Two Key Protagonists / Efectos Nocebo/Placebo en la práctica dental: Dos protagonistas clave

ABSTRACT Understanding the possible effects that a patient's psycho-neurobiological processes (such as the nocebo effect) may have on the every-day dental treatments, could assist the clinicians in preventing the onset of adverse events not related directly with the clinical procedure. At the same time, employing pathways to trigger plausible placebo effects could aid the clinician to enhance the outcome of ordinary clinical procedures and the patient's perspective. Identified factors, which could lead both to positive or negative effects, may be present in different ways. Prior personal experiences, second-hand information, alternative medicine, catastrophizing or patient motivation; all could have an indirect effect in the treatment outcome. A well-informed clinician should use such factors to individualize each patient treatment.

RESUMEN Comprender los posibles efectos que los procesos psico-neurobiológicos de un paciente (como el efecto nocebo) pueden tener en los tratamientos dentales diarios, podría ayudar a los clínicos a prevenir la aparición de eventos adversos que no estén relacionados directamente con el procedimiento clínico. Al mismo tiempo, el uso de vías para favorecer posibles efectos placebo podría ayudar al clínico a mejorar el resultado de sus procedimientos rutinarios y la perspectiva del paciente. Los factores identificados, ya sean positivos o negativos, pueden estar presentes de diferentes maneras. Experiencias personales anteriores, información de segunda mano, medicina alternativa, actitud catastrófica o motivación del paciente; todos podrían tener un efecto indirecto en el resultado del tratamiento. Un médico bien informado debe usar dichos factores para individualizar el tratamiento de cada paciente.

Análisis ético de la entrega parcial de información al paciente para prevenir efectos nocebo / Partial disclosure of information in the presence of presumable nocebo effects: an ethical analysis

When prescribing a treatment, the physician should give truthful information about the likely benefits and the potential adverse effects, allowing the patient to make an autonomous decision about whether to take the treatment. However, the mere expectation of adverse effects may precipitate the corresponding symptoms. This is called "nocebo effect", which in contrast to the placebo effect, can lead to harm to the patient due to psychological factors. Nocebo effects are common and clinically significant, although often unnoticed. This situation generates conflicts in medical ethics guiding principles, namely the moral obligation to disclose all possible effects of the prescribed drug as opposed to the duty of avoiding the harm of side effects that are likely to occur in a case. In other words, the physician faces a dilemma between the due respect for autonomy and the duty of non-maleficence. This article reflects about this conflict, by exploring the limits of the principle of autonomy and how to balance it with the principle of non-maleficence. We suggest an interpretation of the principle of autonomy from a patient-centered perspective, suggesting that it is ethically sound to give a prudential, partial disclosure of information to the patient, for the sake of avoiding potential nocebo effects. The article concludes with some cautionary considerations to be considered about this decision.

Vigencia del efecto placebo: su biología desde la genética a la conducta / Biological and genetic mechanisms underlying the placebo effect

The placebo effect has been seldom studied in the history of medicine. However, during the last decades, the great impact of this phenomenon in clinical practice, ranging from surgical to psychiatric field, has been revealed. Research elucidated both the psychological mechanisms and genetic polymorphisms that affect the susceptibility of individuals to express this phenomenon. We herein review the psychological mechanisms, brain structures (anterior cingulate cortex, nucleus accumbens, dorsolateral prefrontal cortex, insular cortex, thalamus) and neurotransmission systems involved (opioid, dopaminergic, cannabinoid, serotoninergic, cholecystokinin). These are the clue to recognize the polymorphisms that have been identified so far. The biological basis of both the placebo effect and its alter ego, the nocebo effect, are well recognized, and related to corresponding psychological processes. Finally, the implications of the findings in clinical practice and medical training are discussed.

Uso de placebos em pesquisas com fins comerciais: limitações jurídicas à luz do ordenamento brasileiro / Placebo use in research with commercial purposes: legal restrictions in the light of the Brazilian legal system

Muito se discutem as pesquisas em seres humanos com uso de placebos sob o ponto de vista bioético, em especial à luz dos princípios bioéticos da autonomia, justiça e equidade. No entanto, não desconsiderando a importância dessas discussões, o assunto deve ser pensado também sob seu aspecto jurídico, particularmente no que se refere às pesquisas com fins comerciais. O presente artigo, a partir de pesquisa bibliográfica interdisciplinar, tem por objetivo discutir, à luz do ordenamento jurídico brasileiro, como devem ser tratadas as relações jurídicas decorrentes das pesquisas com uso de placebos financiadas por laboratórios e farmacêuticas e como devem ser aferidas as responsabilidades em caso de danos provocados ao pesquisado.

There are many ethical discussions about the use of placebo in research with humans. These discussions often occur from a bioethical standpoint, particularly in the light of the bioethical principles of autonomy, justice and equity. However, and without disregarding the importance of these discussions, the legal aspect should also be considered, particularly concerning medical research with commercial purposes. This article, from a literature interdisciplinary review, aims to discuss, in the light of the Brazilian legal system, how research using placebo and financed by laboratories and pharmaceutical companies should be tackled and how to assess the liability arising from this research in case of damage caused to the participants.

Nocebo effect in dermatology.

Nocebo effect, originally denoting the negative counterpart of the placebo phenomenon, is now better defined as the occurrence of adverse effects to a therapeutic intervention because the patient expects them to develop. More commonly encountered in patients with a past negative experience, this effect stems from highly active processes in the central nervous system, mediated by specifi c neurotransmitters and modulated by psychological mechanisms such as expectation and conditioning. The magnitude of nocebo effect in clinical medicine is being increasingly appreciated and its relevance encompasses clinical trials as well as clinical practice. Although there is hardly any reference to the term nocebo in dermatology articles, the phenomenon is encountered routinely by dermatologists. Dermatology patients are more susceptible to nocebo responses owing to the psychological concern from visibility of skin lesions and the chronicity, unpredictable course, lack of ‘permanent cure’ and frequent relapses of skin disorders. While fi nasteride remains the prototypical drug that displays a prominent nocebo effect in dermatologic therapeutics, other drugs such as isotretinoin are also likely inducers. This peculiar phenomenon has recently been appreciated in the modulation of itch perception and in controlled drug provocation tests in patients with a history of adverse drug reactions. Considering the confl ict between patients’ right to information about treatment related adverse effects and the likelihood of nocebo effect stemming from information disclosure, the prospect of ethically minimizing nocebo effect remains daunting. In this article, we review the concept of nocebo effect, its postulated mechanism, relevance in clinical dermatology and techniques to prevent it from becoming a barrier to effective patient management.

Placebo and nocebo effects in the neurological practice / Efeitos placebo e nocebo na prática neurológica

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.

O conhecimento dos efeitos placebo e nocebo é essencial para identificar a sua influência sobre os resultados na prática clínica e ensaios clínicos, e, assim, interpretar corretamente seus resultados. Sabe-se que o padrão-ouro dos estudos clínicos de pesquisa é o ensaio clínico randomizado, placebo-controlado, duplo-cego. O objetivo da revisão é distinguir os efeitos específicos e não específicos, de modo que a presença de efeitos positivos no grupo que recebeu placebo (efeito placebo) e a presença de efeitos adversos no grupo que recebeu placebo (efeito nocebo) levam à confusão na interpretação dos resultados. Placebo e nocebo são descritos em doenças neurológicas como a depressão, dor, cefaleia, esclerose múltipla, epilepsia. Como os efeitos placebo e nocebo também se projetam na prática clínica, o objetivo desta revisão é o de destacar sua influência na prática neurológica, chamando a atenção para o desenvolvimento de medidas que possam minimizá-los.

Efeito nocebo e consentimento informado contextualizado: reflexões sobre aplicação em oftalmologia / Effect nocebo, and the contextualized informed consent: some thoughts on its application in ophthalmology

O respeito ao princípio da autonomia e consentimento informado obriga o médico a explicar ao paciente os efeitos secundários das terapêuticas que prescreve. Entre eles, há o chamado efeito nocebo, cujas especificidades, detalhadas neste artigo a partir da oftalmologia, implica que o fornecimento da informação possa vir a contrariar o princípio da não maleficência a pacientes vulneráveis. O consentimento informado em oftalmologia para drogas off-label traz nova questão ético-jurídica, que este artigo aborda a partir dos riscos do efeito nocebo. O médico tem o dever de esclarecer e o paciente, o direito de ser esclarecido sobre as vantagens, desvantagens, riscos, benefícios de qualquer medicação. O "consentimento informado contextualizado" pretende atenuar a resposta nocebo de modo a preservar tanto a autonomia do paciente quanto a ação não maleficente do médico...

The respect to the principle of autonomy and informed consent obligates physicians to explain patients the possible side effects when prescribing medications. This disclosure may itself induce adverse effects or negative placebo. This fact contradicts the principle of non-maleficence in vulnerable patients as in ophthalmological disease. There is some tension between information to the patient that takes into account possible side effects. The Informed consent to patient for off label drugs used for example in ophthalmology is a new contextualized legal ethical question. This article has for objective to alert to the doctor for the effect risk nocebo. The doctor has the duty to explain and the patient the right to be explained about the advantages, disadvantages, risks and benefits of any medication. The contextualized informed consent suggests a pragmatic approach for providers to minimize nocebo responses while still maintaining patient autonomy through, by means of the form as it informs...

El respeto al principio de la autonomía y consentimiento informado obliga al médico explicar al paciente los efectos secundarios de las terapéuticas prescritas. Entre ellos, existe el llamado efecto nocebo, cuyas especificidades, detalladas en este artículo desde la oftalmología, supone que el suministro de la información pueda contradecirse al principio de la no maleficencia a pacientes vulnerables. El consentimiento informado en oftalmología para drogas off-label trae una nueva cuestión ético-jurídico que plantea este artículo a partir de los riesgos del efecto nocebo. El médico tiene el deber de aclarar y el paciente el derecho de ser aclarado acerca de las ventajas, las desventajas, los riesgos, beneficios de cualquier medicamento. El "consentimiento informado contextualizado" pretende mitigar la respuesta nocebo para preservar tanto la autonomía del paciente cuanto a la acción no maleficente del médico...

El Homo sapiens, la fe y el efecto placebo / Homo sapiens, faith and the placebo effect

Los llamados efecto placebo y nocebo son efectos reales que resultan de la interacción entre la actividad mental y el estado funcional del organismo. Esta interacción se puede describir hoy en términos precisos a través de la influencia que las estructuras del sistema límbico ejercen sobre el hipotálamo y las regiones del tallo cerebral que controlan las funciones endocrina, motora y vegetativa. El conocimiento de estos mecanismos pone de relieve la importancia de factores sugestivos, como la confianza en el terapeuta o en el tratamiento indicado, en la curación de enfermedades o de sus secuelas. Existen evidencias de que algunas terapias sin una base científica sólida como la acupuntura, la homeopatía o la terapia floral, logran sus resultados a través de estos mecanismos. Incorporar los principios psicobiológicos que origina el efecto placebo a la relación médico paciente, puede resultar una contribución positiva para una medicina más efectiva y humana, pero siempre dentro de los límites que imponen la ética de no mentir y el respeto a la integridad e inteligencia de los pacientes

The so called placebo and nocebo effects are real, and result from the interaction between the mental activity and the functioning of the body. This interaction is presently described in precise terms as the influence exerted by limbic structures on the hypothalamus and on the brain stem's nuclei that control the endocrine, motor and vegetative functions. Understanding of these mechanisms discloses the important role played by suggestion, like trusting your therapist or trusting the treatment, in the cure of diseases and their sequels. There is also evidence that therapies without a strong scientific foundation, like acupuncture, homeopathy or flower therapy, can achieve some results based on these mechanisms. The introduction of the psychobiological principles governing the effect of placebo into the medical practice could contribute to a more effective and human medicine, provided that the ethical limits imposed by the truth and the respect to the patient´s integrity and intelligence are observed

De placebos y nocebos: la sanación por las palabras / About placebos and nocebos: healing through words

El concepto de efecto placebo, aplicado principalmente al manejo terapéutico del dolor, ha sido extensamente estudiado y se refiere a la posibilidad de obtener efectos analgésicos mediante la administración de sustancias inertes. La evidencia opuesta, es decir la inducción del dolor mediante sugestión verbal, ha dado lugar al concepto de nocebo, que implica que la expectativa de un hecho negativo puede llevar, de por si, al empeoramiento de un síntoma. La propuesta neuroquímica del fenómeno placebo-nocebo implica la presencia de sistemas neuronales opuestos, activados por las expectativas con respecto al dolor. Los opioides mediarían la analgesia placebo mientras que la colecistokinina sería la responsable del aumento del dolor. La sanación por la palabra, a la luz de los conocimientos actuales, implicaría que hay un nexo entre los efectos psicosociales y farmacológicos, importante desde el punto de vista del manejo terapéutico del dolor.

The concept of "the placebo effect", mainly applied to the therapeutic management of pain, has been extensively studied and refers to the possibility to obtain analgesic effects through the administration of inert substances. The opposite evidence, i.e. the induction of pain through verbal suggestions, has validated the concept of nocebo effect, that implies that the expectative of a negative event could cause, per se, the worsening of a symptom. The neurochemical approach of the placebo-nocebo phenomenon involves the existence of opposite neuronal systems, activated for expectations regarding pain. Opioids would mediate placebo analgesia whereas cholecystokinin would account for the increase in pain. Healing through words, under the light of the present knowledge, would imply that a link exists between psychosocial and pharmacologic effects, important from the point of view of the therapeutic management of pain.