Perceived quality of life by patients with immune-mediated inflammatory diseases treated with biological therapies. SACVINFA study.

OBJECTIVES: To evaluate health-related quality of life perceived by patients with the most prevalent immune-mediated inflammatory diseases in Spain: inflammatory bowel disease (IBD), psoriasis (Ps), psoriatic arthritis (AP), rheumatoid arthritis (RA), and spondyloarthropathies (SpAs), and to determine the factors that influence patient quality of life. METHODS: The SACVINFA study (SA=satisfaction, CV=quality of life, IN=immune-mediated, FA=pharmacy) consisted of an observational study conducted in 4 hospitals in the Community of Madrid. A cross-sectional analysis was made for adult patients diagnosed with an immune-mediated inflammatory disease who attended the Pharmacy Service. Quality of life was assessed using the EQ-5D-5L questionnaire (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) and specific questionnaires: SIBDQ-9, DLQI, PsAQoL, QoL-RA, and ASQoL. RESULTS: A total of 578 patients were analysed (inflammatory bowel disease=25.3%; psoriasis=19.7%; spondyloarthropathies=18.7%; rheumatoid arthritis=18.5%; psoriatic arthritis=17.8%). The mean age (standard deviation) was 49.8 (12.3) years and 50.7% were male. The average score (standard deviation) for the global EQ-5D-5L was 0.771 (0.2) and the mean (standard deviation) visual analogue scale score was 71.5 (20.0). Type of immune-mediated inflammatory diseases was associated with differences in quality of life showing psoriasis and inflammatory bowel disease higher values of EQ5D-5L than psoriatic arthritis, rheumatoid arthritis, and spondyloarthropathies, p<.05 in all comparisons. Patients with RA, IBD, and Ps achieved 70% of the maximum score, while patients with PsA and SpAs did not reach 50% of the maximum possible score. Female gender, a state of moderate/severe disease severity, an older age, and a higher number of previous treatments were correlated with worse quality of life. Conversely, persistence to current treatment correlated with better quality of life. CONCLUSIONS: Patients with immune-mediated inflammatory diseases have markedly affected quality of life, mainly in the pain/discomfort dimension, especially in those immune-mediated inflammatory diseases with a rheumatological component.

Efectos de Cinnamomum zeylanicum en niveles glucémicos en pacientes con diabetes tipo 2: ensayo clínico aleatorizado / Effects of Cinnamomum zeylanicum on glycemic levels in patients with type 2 diabetes: Randomized clinical trial

Objetivo: Evaluar el efecto del consumo de suplemento de Cinnamomum zeylanicum (canela) en los niveles glucémicos de adultos mexicanos con diabetes tipo 2. Métodos: Se realizó un ensayo clínico aleatorizado simple ciego con 30 pacientes >18 años con diabetes tipo 2, se aleatorizaron en los grupos: intervención y control; donde consumieron cápsulas con 2 gramos de C. zeylanicum o harina de trigo (placebo) diario por 12 semanas y se midieron variables antropométricas y bioquímicas (HbA1c, GPa, triglicéridos, colesterol total, HDL y LDL). Se utilizó el software IBM SPSS versión 23 y se aplicó la prueba T-Student y U-Mann Withney para muestras independientes (según el comportamiento de la variable) para las diferencias entre grupos, valores p<0.05 fueron considerados estadísticamente significativos. Resultados: No se observaron cambios significativos en HbA1c entre grupos (p>0.05). Sin embargo, post-tratamiento el grupo intervención disminuyó significativamente HbA1c al compararlo con su línea base (-0.41%, p=0.01) mientras que no se encontraron diferencias en el grupo control (+0.03%, p=0.64). No hubo diferencias significativas en variables antropométricas ni bioquímicas. Conclusiones: El consumo de 2 g de C. zeylanicum en mexicanos con diabetes tipo 2 no produjo cambios significativos entre grupos. Se sugieren nuevos estudios donde se evalúe el suplemento de canela con una muestra mayor. ClinicalTrials.gov; NCT04023539. (AU)

Objective: To evaluate the effect of Cinnamomum zeylanicum (cinnamon) supplement use on the glycemic levels of Mexican adults with type 2 diabetes. Methods: A single-blind randomized clinical trial was conducted with 30 patients over 18 years of age with type 2 diabetes. They were randomized into intervention and control groups where they took 2-gram capsules of Cinnamomum zeylanicum or wheat flour (placebo) daily for 12 weeks; then the anthropometric and biochemical variables HbA1c, FPG, triglycerides, total cholesterol, HDL and LDL were measured. IBM SPSS version 23 software was used and the Student's t-test and Mann-Whitney U test for independent samples (according to the behavior of the variable) were applied for differences between groups, p-values <0.05 were considered statistically significant. Results: No significant changes in HbA1c were seen between the two groups (p>0.05). However, post-treatment, the HbA1c value in the intervention group decreased significantly when compared to their baseline (-0.41%, p=0.01), while no differences were found in the control group (+0.03%, p=0.64). There were no significant differences in the anthropometric or biochemical variables. Conclusions: The consumption of 2 g of Cinnamomum zeylanicum in Mexican people with type 2 diabetes did not produce significant changes between the groups. New studies evaluating cinnamon supplementation on a larger sample size are suggested. ClinicalTrials.gov; NCT04023539. (AU)

Cognitive-behavioural conjoint therapy versus prolonged exposure for PTSD in military service members and veterans: results and lessons from a randomized controlled trial.

Military personnel and veterans are at heightened risk for exposure to traumatic events and posttraumatic stress disorder (PTSD), as well as intimate relationship problems associated with PTSD.The purpose of this study was to evaluate the relative efficacy of CBCT and PE in improving intimate relationship functioning in active duty military personnel or veterans and their intimate partners; both conditions were hypothesized to significantly improve PTSD. Method: In this study, 32 military service members or veterans with PTSD and their intimate partners were randomized to receive either Cognitive-Behavioral Conjoint Therapy for PTSD (n = 15; CBCT; [Monson, C. M., & Fredman, S. J. (2012). Cognitive-behavioral conjoint therapy for posttraumatic stress disorder: Harnessing the healing power of relationships. Guilford]), a trauma-focused couple therapy, or Prolonged Exposure (n = 17; PE; [Foa, E. B., Hembree, E. A., Dancu, C. V., Peterson, A. L., Cigrang, J. A., & Riggs, D. S. (2008). Prolonged exposure treatment for combat-related stress disorders - provider's treatment manual [unpublished]. Department of Psychiatry, University of Pennsylvania]), a front-line evidence-based individual treatment for PTSD.There were significant challenges with recruitment and a significant difference in dropout from treatment for the two therapies (65% for PE; 27% for CBCT). Treatment dropout was differentially related to pre-treatment relationship functioning; those with below average relationship functioning had higher dropout in PE compared with CBCT, whereas those with above average relationship functioning did not show differential dropout. In general, CBCT led to relational improvements, but this was not consistently found in PE. Clinician- and self-reported PTSD symptoms improved with both treatments.This study is the first to test a couple or family therapy against a well-established, front-line recommended treatment for PTSD, with expected superiority of CBCT over PE on relationship outcomes. Lessons learned in trial design, including considerations of equipoise, and the effects of differential dropout on trial analyses are discussed. This trial provides further support for the efficacy of CBCT in the treatment of PTSD and enhancement of intimate relationships.

Differential dropout from trial of couple versus individual therapy for PTSD.General pattern of improvements in relationship outcomes in couple therapy for PTSD.PTSD symptoms improved in the individual and couple therapy for PTSD.Lessons learned in trial design, including considerations of equipoise, and the effects of differential dropout by condition on trial analyses are discussed.

The impact of COVID-19 and other factors on the usage status of the biologic drug therapies for rheumatoid arthritis: A study from Vietnam.

OBJECTIVES: To describe the status of using biological Disease Modifying Anti Rheumatic Drugs (bDMARDs) to treat rheumatoid arthritis (RA) and related factors. In addition, the study determined the impact of COVID-19 on the usage of bDMARDs. METHODS: This is a cross-sectional study and included 219 RA patients over 18 years old. The Kaplan-Meier method and the log-rank test (p<0.05) were used to estimate the retention time and compare between different times. Cox regression analysis was used to determine the factors affecting the retention time of biological drugs (p<0.05). RESULTS: Out of 1967 courses of treatment, there were 149 (7.6%) drug discontinuations, 760 (38.6%) doses extensions and 64 (3.3%) drug switch. Moderate disease level and choosing tumor necrosis factor (TNF) inhibitors initially were associated with retention time of COVID-19. Drug discontinuations and dose extensions increased after COVID-19 emergence. The retention time during COVID-19 was significantly different from that of pre-COVID-19. Gender, type of first-used bDMARD, conventional synthetic DMARDs (csDMARDs) and corticoid usage status, disease activity levels were associated with retention time. CONCLUSION: The presence of COVID-19 has a significant effect on usage status of the biologic drug. Further longitudinal studies are needed to clarify the relationship between COVID-19 and drug usage as well as related factors.

[Management of chronic non-oncologic pain by multicomponent programs using non-pharmacologic therapies: A systematic review of the literature]. / Manejo del dolor crónico no oncológico con programas multicomponentes de terapias no farmacológicas: revisión sistemática de la literatura.

Chronic pain is a public health problem suffered by 20% of the world's population. Pharmacological approaches are insufficient, so a multi-therapeutic approach that also includes non-pharmacological therapies (psychological therapies, meditation, physical exercise, healthy habits, etc.) is proposed. The aim of this review was to review the existing scientific evidence on the effect of multicomponent programs with non-pharmacological therapies in people with chronic non-oncologic pain. To this end, a search for scientific articles was carried out in three databases (PubMed, Web of Science and PsycINFO) and 17 articles were selected, following the PRISMA recommendations. The patients who participated in these programs were mostly women, aged 18 to 80years, working or on sick leave due to pain, with secondary education or less and married. The most frequent pain was musculoskeletal, mainly low back pain. All the articles studied the effectiveness of two or more therapies, highlighting psychological therapies, physical exercise and education. Positive results were obtained in the reduction of different variables such as pain, pain catastrophizing, anxiety and depression, in addition to improving functionality and quality of life. It has also been shown that patients' prior expectations regarding the intervention influence its effectiveness. Although throughout the review there was great heterogeneity in the interventions, in the evaluation methods and in the results themselves, it can be concluded that multicomponent programs show positive results in the management of chronic pain, and should therefore be incorporated as a routine therapeutic treatment.

[Epidemiological and treatment characteristics of patients with chronic obstructive pulmonary disease on maintenance inhaled therapy between 2011 and 2019 in Hungary]. / A krónikus obstruktív tüdobetegség miatt fenntartó inhalációs kezelésben részesült betegek epidemiológiai és terápiás jellemzoi 2011 és 2019 között Magyarországon.

Introduction: Morbidity and mortality due to chronic obstructive pulmonary disease (COPD) are on the rise worldwide. The cornerstone of treatment is maintenance inhaled therapy and the patients' good treatment adherence. Objective: To determine epidemiological and treatment characteristics of patients treated with COPD in Hungary. Methods: Using data from the National Health Insurance Fund, we recruited patients under maintenance inhaled therapy due to COPD between 2011 and 2019 (aged >40 years, who filled in at least one prescription of a maintenance inhaled drug for ICD (International Classification of Diseases) code J44, which was followed by two further prescriptions within 1 year). Data of patients were analysed every year after inclusion. Findings on age, sex, inhaled therapies, and the use of retard oral theophylline were compared among the years (chi2 test). Results: In total, 227,251 patients were included (2011­2019: 81,308­160,241 patients/year). In 2011, most patients were >70 years of age and males, while in 2019, most patients were 60­69 years old and females. The proportion of patients filling in a prescription for mono-bronchodilators or inhaled corticosteroids decreased in the observational period, while dual bronchodilators became available, and their use gradually increased. The adherence to maintenance inhaled therapies was good (>180 days/year) only in approximately half of the population (51.6% in 2019). The number of patients filling in prescriptions for oral theophylline did not decline in the observation period (32% in 2019). Discussion: Between 2011 and 2019, the number of COPD patients on maintenance inhaled therapy did not reach that of the registered patients. Adherence to maintenance inhaled treatment is inadequate in a significant portion of patients. The rate of patients taking oral theophylline is high. Conclusion: Improvement of adherence to maintenance inhaled therapies is essential for a better prognosis of COPD in Hungary. Orv Hetil. 2024; 165(9): 338­345.

The impact of COVID-19 and other factors on the usage status of the biologic drug therapies for rheumatoid arthritis: A study from Vietnam / El impacto de COVID-19 y otros factores en el estado de uso de las terapias farmacológicas biológicas para la artritis reumatoide: un estudio de Vietnam

Objectives: To describe the status of using biological Disease Modifying Anti Rheumatic Drugs (bDMARDs) to treat rheumatoid arthritis (RA) and related factors. In addition, the study determined the impact of COVID-19 on the usage of bDMARDs. Methods: This is a cross-sectional study and included 219 RA patients over 18 years old. The Kaplan–Meier method and the log-rank test (p<0.05) were used to estimate the retention time and compare between different times. Cox regression analysis was used to determine the factors affecting the retention time of biological drugs (p<0.05). Results: Out of 1967 courses of treatment, there were 149 (7.6%) drug discontinuations, 760 (38.6%) doses extensions and 64 (3.3%) drug switch. Moderate disease level and choosing tumor necrosis factor (TNF) inhibitors initially were associated with retention time of COVID-19. Drug discontinuations and dose extensions increased after COVID-19 emergence. The retention time during COVID-19 was significantly different from that of pre-COVID-19. Gender, type of first-used bDMARD, conventional synthetic DMARDs (csDMARDs) and corticoid usage status, disease activity levels were associated with retention time. Conclusion: The presence of COVID-19 has a significant effect on usage status of the biologic drug. Further longitudinal studies are needed to clarify the relationship between COVID-19 and drug usage as well as related factors.(AU)

Objetivos: Describir el estado del uso de fármacos antirreumáticos modificadores de la enfermedad biológica (bDMARD) para tratar la artritis reumatoide (AR) y los factores relacionados. Además, el estudio determinó el impacto de COVID-19 en el uso de bDMARD. Métodos: Este es un estudio transversal que incluyó a 219 pacientes con AR mayores de 18 años. El método Kaplan-Meier y la prueba Log-rank (p<0,05) se usaron para estimar el tiempo de retención y compararlo entre diferentes tiempos. El análisis de regresión de Cox se utilizó para determinar los factores que afectan el tiempo de retención de los medicamentos biológicos (p<0,05). Resultados: De 1.967 cursos de tratamiento, hubo 149 (7,6%) interrupciones del fármaco, 760 (38,6%) extensiones de dosis y 64 (3,3%) cambios de fármaco. Nivel de enfermedad moderado y elección del factor de necrosis tumoral (TNF) inhibidores inicialmente se asociaron con el tiempo de retención de COVID-19. Las discontinuaciones de los medicamentos y las extensiones de las dosis aumentaron después de la aparición de COVID-19. El tiempo de retención durante COVID-19 fue significativamente diferente del pre-COVID-19. Género, tipo de bDMARD de primer uso, convencional DMARD sintéticos (csDMARDs) y el estado de uso de corticoides, los niveles de actividad de la enfermedad se asociaron con el tiempo de retención. Conclusión: La presencia de COVID-19 tiene un efecto significativo en el estado de uso del medicamento biológico. Se necesitan más estudios longitudinales para aclarar la relación entre COVID-19 y el uso de fármacos, así como los factores relacionados.(AU)

Evidence on the use of alternative substances and therapies in hypertension / Evidencias sobre el uso de sustancias y terapias alternativas en hipertensión

Objective: Review of some of the best-known biological and non-biological complementary/alternative therapies/medicines (CAM) and their relationship with blood pressure (BP) and hypertension (HT). Search strategy: Narrative review assessing a recent series of systematic reviews, meta-analyses, and clinical trials published in recent years, focusing on the effects of CAM on BP and HT. Selection of studies: We searched EMBASE, MEDLINE, Cochrane Library and Google Scholar, obtaining a total of 4336 articles, finally limiting the search to 181 after applying filters. Synthesis of results: Some studies on biological therapies show some usefulness in BP reduction with an adequate benefit–risk balance, although there is a scarcity of high-quality trials that support these results. Some mind-body therapies have shown hypothetical benefit; in contrast, others lack robust evidence. Conclusions: Although some therapies present a reasonable risk–benefit ratio, they should in no case replace pharmacological treatment when indicated.(AU)

Objetivo: Revisar algunas de las más conocidas terapias/medicinas biológicas y no biológicas complementarias/alternativas (MCA), y su relación con la presión arterial (PA) e hipertensión arterial (HTA). Estrategia de búsqueda: Revisión narrativa en la que se valoraron una serie reciente de revisiones sistemáticas, metaanálisis y ensayos clínicos publicados en los últimos años, centrada en los efectos de la MCA sobre la PA y HTA. Selección de estudios: Se realizaron búsquedas en EMBASE, MEDLINE, Cochrane Library y Google Scholar, obteniéndose un total de 4.336 artículos, limitándose finalmente a 181 tras aplicar filtros. Síntesis de resultados: Algunos trabajos sobre terapias biológicas parecen demostrar cierta utilidad en reducción de la PA con adecuado balance beneficio/riesgo, aunque existe escasez de ensayos de alta calidad que avalen estos resultados. Algunas terapias cuerpo/mente han mostrado un hipotético beneficio; en cambio, otras carecen de evidencia robusta. Conclusiones: Aunque algunas terapias presentan una relación riesgo/beneficio razonable, no deberían sustituir en ningún caso al tratamiento farmacológico cuando este esté indicado.(AU)

[Impact of a multicomponent program with nonpharmacological therapies for patients with chronic pain]. / Impacto de un programa multicomponente con terapias no farmacológicas para pacientes con dolor crónico.

INTRODUCTION: 25.9% of Spanish people suffer from chronic pain. An integrated, interdisciplinary approach is recommended, with pharmacological and non-pharmacological therapies, involving patients in their self-care. OBJECTIVE: To evaluate the effectiveness and impact on resources of a program with non-pharmacological therapies in the control of non-oncological chronic pain in the short and medium term. MATERIAL AND METHODS: Quasi-experimental before-after study, follow-up 3-6 months, measuring: pain, well-being, quality of life, self-esteem, resilience, anxiety/depression (validated scales); patient-reported outcomes of workshop impact on pain management, habits and mood; ED and office visits; drug consumption and employment status. RESULTS: One hundred and forty-two patients completed the program; 131 (92.3%) were women, age: 56.0. Decreased: pain (scale 0-10) (start: 6.0; end of workshop: 4.0; 3 months: 5.0); anxiety (12.9; 10.4; 8.8) and depression (12.3; 7.23; 6.47) (scales 0-21). They increased: well-being (scale 0-10) (4.0; 6.0; 4.0); quality of life (scale 0-1) (0.418; 0.580; 0.536); health status (scale 0-100) (47.5; 60.0; 60.0); self-esteem (scale 9-36) (24.1; 27.5; 26.7); resilience (scale 6-30) (14.8; 17.4; 18.6). Patient-reported outcomes were performed by 136 patients at the end of the workshop and 79 at 3 months: pain decreased (end of program: 104, 76.5%; 3 months: 66, 83.5%); medication decreased (96, 76.2%; 60, 78.9%); habits improved (112, 88.2%; 69, 90.8%). Forty patients (37.4%) reduced visits to the emergency room, 40 (37.4%) reduced scheduled visits. Overall satisfaction: 9.8 out of 10. CONCLUSIONS: Patients learn to mitigate their pain, participate in their self-care and improve their quality of life, self-esteem and emotional state. The effects remained for 3-6 months.

The role of interoception in reducing trauma-associated distress: a feasibility study.

Background: Altered interoception plays an important role in chronic stress and posttraumatic stress disorder. The aim of this study was to evaluate the feasibility of a Trauma Sensitive Yoga (TSY) intervention for improving emotional distress and psychological discomfort in women living under circumstances of social and gender vulnerability. We assessed the effect of the treatment on the interoceptive mechanisms, and whether the psychological improvements were mediated by the changes in these mechanisms.Methods: The study involved a sample of 62 women who attended public community centres dedicated to supporting women victims of gender-based violence or who were socially and economically disadvantaged because of their gender. Participants underwent a six-week TSY programme. We evaluated dropout rate, adherence, and intervention satisfaction. We measured emotional distress, psychological discomfort, interoceptive mechanisms, and two nonequivalent dependent variables to enhance internal validity. We compared pre-post differences using paired samples t-test and a structural equation model (SEM) analysis was performed to compare the changes in the outcomes with the changes in the nonequivalent dependent variables. Mediation models were adjusted to evaluate the role of changes in interoception on outcome changes.Results: Fourteen (23%) women dropped out, mainly after the first intervention session. Intervention adherence (mean attendance 5.3 over 6 sessions) and acceptability were high (mean satisfaction 3.4 over 4). We observed post-intervention improvements in anxiety, depression, psychological discomfort, body responsiveness, and interoceptive awareness. The changes in the outcomes were larger than the changes in the nonequivalent dependent variables. Additionally, we found that the changes in body responsiveness partially mediated the change in anxiety and psychological discomfort but not in depression.Conclusions: TSY could be an interesting therapeutic approach for women experiencing chronic posttraumatic stress symptomatology. Our findings underscore the role of interoceptive mechanisms in traumatic stress and emphasize the importance of addressing these aspects.

A 6-week Trauma Sensitive Yoga programme is feasible and acceptable to address chronic and trauma-related stress in vulnerable women.The intervention reduces emotional distress and psychological discomfort and increases interoceptive awareness.Interoceptive mechanisms could play a crucial role in addressing stress-related symptoms, contributing to the overall positive outcomes.

Técnicas complementarias de relajación y analgesia no farmacológicas durante el parto: revisión sistemática / Complementary techniques of relaxation and non-pharmacological analgesia during childbirth: systematic review

Introducción: Existe la necesidad de proporcionar estrategias de analgesia que alienten y promuevan la participación de la mujer en la toma de decisiones en el momento del parto y las técnicas de relajación podrían ser un método analgésico no far-macológico complementario y/o alternativo a la anestesia epidural ampliamente utilizado. en la estándar atención del trabajo de parto. Objetivo: El objetivode este estudio es analizar los efectos obstétricos de las técnicas de relajación en el manejo del dolor durante el parto. Método: Se realiza una revisión sistemática con lectura crítica de los estudios incluidos. La búsqueda de estudios se realizó en las principales bases de datos MEDLINE, Cochrane Library, Cuiden, LILACS y SciELO. Se incluyen estudios publicados en inglés o español entre 2015 y febrero de 2021. Se incluyen una vez estudios, seis de los cuales son revisados sistemáticamente y cinco son ensayos clínicos aleatorios. Las intervenciones analizadas fueron técnicas de relajación como hipnosis, inyección intradérmica de agua estéril, inmersión en agua tibia, masaje, acu-puntura, musicoterapia, aromaterapia, apoyo continuo y prácticas mente-cuerpo como respiración relajante, yoga y meditación, entre otras. Conclusión: La principal conclusión de este estudio es que las técnicas de relajación pueden disminuir el nivel de dolor durante el trabajo, aunque la evidencia científica actual es limitada y la calidad metodológica varía de baja a moderada. Se necesitan más ensayos controlados aleatorios para apoyar esta investigación (AU)

Introduction:There is a need to provide analgesia strategies that encourage and promote women's participation in decision-making at the time of delivery and relaxation techniques could be a complementary and/or alternative non-pharmacological analgesic method to the widely used epidural anaesthesia in standard labour care. Objective: Theobjective of this study is to analyze the obstetric effects of relaxation techniques on pain management during labour. Method: A systematic review is performed with critical reading of included studies. The search for studies was carried out in the main databases MEDLINE, Cochrane Library, Cuiden, LILACS and SciELO. Studies published in English or Spanish between 2015 and February 2021 were included. Eleven studies were included, six of which are systematic reviews and five are randomised clinical trials. The interventions analysed were relaxation techniques such as hypnosis, intradermal injection of sterile water, warm water immersion, massage, acupuncture, music therapy, aromatherapy, continuous support and mind-body practices like relaxing breathing, yoga and meditation, among others. Conclusion: The main conclusion of this study is that relaxation techniques may decrease the level of pain during labour, although the current scientific evidence is limited and the methodological quality varies from low to moderate. More randomised controlled trials are needed to support this research (AU)

Inmunoterapia vs. terapia diana en el paciente con melanoma avanzado y mutación BRAF V600, ¿por cuál comenzar? / Immunotherapy and Targeted Therapy in Patients With Advanced Melanoma and the V600 BRAF Mutation: Which One First?

El paciente con melanoma avanzado, metastásico o de alto riesgo, cuenta con opciones de tratamiento sistémico, inmunoterapia y terapias dirigidas, que han mejorado significativamente su supervivencia. El 50% de los pacientes con melanoma presentan mutación del gen BRAF. La toma de decisiones en cuanto a la secuencia óptima de tratamiento sistémico debe tener en cuenta factores relacionados con el medicamento, factores clínicos del paciente, así como los propios del tumor. Aunque la combinación ipilimumab-nivolumab es la que proporciona mejores resultados de supervivencia en todos los pacientes, la toxicidad asociada y el perfil de las terapias diana las puede hacer recomendables como primera línea en pacientes en determinadas situaciones clínicas. El objetivo de esta revisión es proporcionar un algoritmo de toma de decisiones en cuanto a la primera línea de tratamiento sistémico, inmunoterapia vs. terapias dirigidas, en el paciente con melanoma avanzado con mutación BRAF (AU)

Systemic treatment with immunotherapy or targeted therapy can significantly improve survival in patients with advanced (metastatic or high-risk) melanoma. Fifty percent of patients with melanoma have a BRAF mutation. Decisions on optimal sequencing of systemic treatments should take into account drug- and tumor-related factors and patient characteristics. Although the combination of ipilimumab and nivolumab is associated with the best survival outcomes, it is associated with significant toxicity. Targeted therapy may be a more favorable option in certain clinical situations. We review the literature on immunotherapy and targeted therapy in melanoma and present an algorithm for guiding decision-making on their use as first-line systemic treatments for advanced BRAF-mutated melanoma (AU)

[Translated article] Immunotherapy and Targeted Therapy in Patients With Advanced Melanoma and the V600 BRAF Mutation: Which One First? / Inmunoterapia vs. terapia diana en el paciente con melanoma avanzado y mutación BRAF V600, ¿por cuál comenzar?

Systemic treatment with immunotherapy or targeted therapy can significantly improve survival in patients with advanced (metastatic or high-risk) melanoma. Fifty percent of patients with melanoma have a BRAF mutation. Decisions on optimal sequencing of systemic treatments should take into account drug- and tumor-related factors and patient characteristics. Although the combination of ipilimumab and nivolumab is associated with the best survival outcomes, it is associated with significant toxicity. Targeted therapy may be a more favorable option in certain clinical situations. We review the literature on immunotherapy and targeted therapy in melanoma and present an algorithm for guiding decision-making on their use as first-line systemic treatments for advanced BRAF-mutated melanoma (AU)

El paciente con melanoma avanzado, metastásico o de alto riesgo, cuenta con opciones de tratamiento sistémico, inmunoterapia y terapias dirigidas, que han mejorado significativamente su supervivencia. El 50% de los pacientes con melanoma presentan mutación del gen BRAF. La toma de decisiones en cuanto a la secuencia óptima de tratamiento sistémico debe tener en cuenta factores relacionados con el medicamento, factores clínicos del paciente, así como los propios del tumor. Aunque la combinación ipilimumab-nivolumab es la que proporciona mejores resultados de supervivencia en todos los pacientes, la toxicidad asociada y el perfil de las terapias diana las puede hacer recomendables como primera línea en pacientes en determinadas situaciones clínicas. El objetivo de esta revisión es proporcionar un algoritmo de toma de decisiones en cuanto a la primera línea de tratamiento sistémico, inmunoterapia vs. terapias dirigidas, en el paciente con melanoma avanzado con mutación BRAF (AU)

Immunotherapy and Targeted Therapy in Patients With Advanced Melanoma and the V600 BRAF Mutation: Which One First? / Inmunoterapia vs. terapia diana en el paciente con melanoma avanzado y mutación BRAF V600, ¿por cuál comenzar?

Systemic treatment with immunotherapy or targeted therapy can significantly improve survival in patients with advanced (metastatic or high-risk) melanoma. Fifty percent of patients with melanoma have a BRAF mutation. Decisions on optimal sequencing of systemic treatments should take into account drug- and tumor-related factors and patient characteristics. Although the combination of ipilimumab and nivolumab is associated with the best survival outcomes, it is associated with significant toxicity. Targeted therapy may be a more favorable option in certain clinical situations. We review the literature on immunotherapy and targeted therapy in melanoma and present an algorithm for guiding decision-making on their use as first-line systemic treatments for advanced BRAF-mutated melanoma.

[Translated article] Immunotherapy and Targeted Therapy in Patients With Advanced Melanoma and the V600 BRAF Mutation: Which One First?

Systemic treatment with immunotherapy or targeted therapy can significantly improve survival in patients with advanced (metastatic or high-risk) melanoma. Fifty percent of patients with melanoma have a BRAF mutation. Decisions on optimal sequencing of systemic treatments should take into account drug- and tumor-related factors and patient characteristics. Although the combination of ipilimumab and nivolumab is associated with the best survival outcomes, it is associated with significant toxicity. Targeted therapy may be a more favorable option in certain clinical situations. We review the literature on immunotherapy and targeted therapy in melanoma and present an algorithm for guiding decision-making on their use as first-line systemic treatments for advanced BRAF-mutated melanoma.

Centros de Atenção Psicossocial e formação profissional para oferta das Práticas Integrativas e Complementares: estudo com profissionais ofertantes dos serviços / Psychosocial care centers and professional training for the provision of integrative and complementary practices: a study with professionals offering these services / Centros de Atención Psicosocial y formación profesional para oferta de las Prácticas Integradoras y Complementarias: estudio con profesionales ofertantes de los servicios

Estudos sobre a formação em Práticas Integrativas e Complementares têm se concentrado na análise curricular dos cursos da Saúde e as pesquisas abrangendo as percepções dos profissionais a respeito dos processos formativos devem ser mais elucidadas. O estudo objetiva identificar os processos de formação e capacitação dos profissionais ofertantes de Práticas Integrativas e Complementares nos Centros de Atenção Psicossocial de uma região metropolitana. Trata-se de um estudo descritivo, exploratório, de abordagem qualitativa. Realizaram-se entrevistas semiestruturadas com 45 profissionais, as quais foram posteriormente analisadas segundo a Análise de Conteúdo Temática. As pós-graduações, graduação, formações em serviço e o ensino privado foram as trajetórias adotadas pelos profissionais, revelando a existência de uma formação difusa para a oferta no cenário investigado. Esses resultados podem subsidiar o planejamento de estratégias educacionais para a ordenação dos recursos humanos em Práticas Integrativas e Complementares.

Studies of training in integrative and complementary practices have concentrated on the analysis of the curriculums of health courses and further more in-depth research into professionals' perceptions about training processes is needed. This study aimed to identify training processes and capacity building for professionals who offer integrative and complementary practices in psychosocial care centers in a metropolitan region. We conducted an exploratory descriptive study involving semi-structured interviews with 45 professionals. The interview transcripts were analyzed using content analysis. The most common routes taken by the professionals were post-graduate qualifications, degrees, in-service training and private education. The results reveal that training in this area was diffuse. Our results can inform the development of educational strategies for the organization of human resources in the area of integrative and complementary practices.

Los estudios sobre la formación en Prácticas Integradoras y Complementarias se han concentrado en el análisis curricular de los cursos de la salud y las investigaciones que incluyen las percepciones de los profesionales con relación a los procesos de formación deben elucidarse más. El objetivo del estudio es identificar los procesos de formación y capacitación de los profesionales ofertantes de Prácticas Integradoras y Complementarias en los Centros de Atención Psicosocial de una región metropolitana. Se trata de un estudio descriptivo, exploratorio, de abordaje cualitativo. Se realizaron entrevistas semiestructuradas con 45 profesionales que fueron posteriormente analizadas según el Análisis de Contenido Temático. Los postgrados, graduación, formaciones en servicio y la enseñanza privada fueron las trayectorias adoptadas por los profesionales, revelando la existencia de una formación difusa para la oferta en el escenario investigado. Esos resultados pueden subsidiar la planificación de estrategias educativas para la ordenación de los recursos humanos en las Prácticas Integradoras y Complementarias.

Caminhos possíveis da avaliação econômica para práticas integrativas e complementares nas condições crônicas / Possible paths of economic assessment for integrative and complementary practices in chronic conditions

Resumo Objetivos Analisar desenhos de avaliação econômica em Práticas Integrativas e Complementares em Saúde (PICS). Métodos O estudo é uma revisão integrativa de estudos disponíveis na Biblioteca Virtual em Saúde, de 2009 a 2021. Resultados Vinte e um estudos foram selecionados para análise final, apresentando importante conformidade com as recomendações dos especialistas. Em geral, a população foi composta por mulheres adultas com distúrbios osteomusculares, que receberam terapias manipulativas, acupuntura/acupressão e homeopatia. Para avaliar essas intervenções, foram utilizadas as perspectivas da sociedade ou do provedor, a partir de análises de custo-efetividade e de custo-consequência, concentrando-se em estimar os custos diretos de saúde, e por vezes, os custos indiretos. Quanto aos desfechos, a maioria dos estudos coletou mais de uma medida, principalmente relacionadas a manifestações sintomáticas, bem-estar global e/ou fatores psicossociais. Conclusões A avaliação econômica está evoluindo para considerar perspectivas mais amplas, com maior variedade de custos e resultados, adaptando-se a diversos cenários de intervenção, atendendo às especificidades das PICS. Conciliar o desenho metodológico ao contexto de inserção das PICS no Brasil é possível e necessário, dada a carência de avaliações nacionais, aos vieses gerados por comparações internacionais e às disputas pela sustentabilidade desse conjunto de práticas no Sistema Único de Saúde.

Abstract Objectives To analyze economic evaluation designs in Integrative and Complementary Health Practices (PICS). Methods This study is an integrative review of available studies in the Virtual Health Library, from 2009 to 2021. Results Twenty-one studies were selected for final analysis, showing significant compliance with the experts' recommendations. In general, the population consisted of adult women with musculoskeletal disorders, who received manipulative therapies, acupuncture/acupressure and homeopathy. To evaluate these interventions, society's or provider's perspectives were used, based on cost-effectiveness and cost-consequence analyses, focusing on estimating direct health costs, and sometimes indirect costs. As for outcomes, most studies collected more than one measure, mainly related to symptomatic manifestations, overall well-being and/or psychosocial factors. Conclusions The economic evaluation is evolving to consider broader perspectives, with a greater variety of costs and results, adapting to different intervention scenarios, meeting the specificities of PICS. Reconciling methodological design and PICS' context of insertion in Brazil is possible and necessary, given the lack of national assessments, the biases generated by international comparisons, and the disputes over the sustainability of this set of practices in the Brazilian Unified Healht System.

Efetividade da terapia Reiki para ansiedade pré-operatória na cirurgia cardíaca: ensaio clínico randomizado / Efectividad de la terapia de reiki para ansiedad preoperatoria en cirugía cardíaca: ensayo clínico aleatorizado / Effectiveness of Reiki therapy for preoperative anxiety in cardiac surgery: a randomized clinical trial

Resumo Objetivo Avaliar a efetividade de um protocolo de Reiki nos níveis de ansiedade no período pré-operatório de cirurgia cardíaca. Métodos Ensaio clínico controlado e randomizado realizado em um hospital universitário de referência em cardiologia entre junho e dezembro de 2021. Foi realizada randomização em bloco e alocação por sorteio com envelopes selados opacos em dois grupos: Controle (n=44; não submetido a intervenção) e Intervenção (n=44; submetido a duas sessões de Reiki três dias antes e na véspera da cirurgia). Os desfechos principais (ansiedade, bem-estar e tensão muscular) foram avaliados ao longo das sessões usando um modelo de efeitos mistos. Para avaliar o tamanho do efeito foram calculados os valores parciais de eta quadrado (η2p). Resultados Foram determinadas as diferenças nos escores de ansiedade (+2,7 pontos a mais para o controle), bem-estar (-0,78) e tensão muscular (1,27), sendo consideradas estatisticamente significativas (p<0,001). Na análise do tamanho do efeito, o experimento distinguiu melhor a variação na variável ansiedade (η2p=0,74) que nas outras duas variáveis (η2p=0,14; η2p=0,23). Conclusão O estudo oferece evidência favorável para efetividade do Reiki no controle da ansiedade pré-operatória de cirurgia cardíaca.

Resumen Objetivo Evaluar la efectividad de un protocolo de reiki en los niveles de ansiedad en el período preoperatorio de cirugías cardíacas. Métodos Ensayo clínico controlado y aleatorizado, realizado en un hospital universitario de referencia en cardiología entre junio y diciembre de 2021. La aleatorización se realizó por bloques y la asignación por sorteo con sobres cerrados opacos en dos grupos: Control (n=44, sin intervención) y Experimental (n=44, sometidos a dos sesiones de reiki, una tres días antes y otra en la víspera de la cirugía). Los criterios de valoración principales (ansiedad, bienestar y tensión muscular) fueron evaluados a lo largo de las sesiones, mediante un modelo de efectos mixtos. Para evaluar el tamaño del efecto se calcularon los valores parciales de eta cuadrado (η2p). Resultados Se observaron diferencias en la puntuación de ansiedad (+2,7 puntos más en el grupo de control), bienestar (-0,78) y tensión muscular (1,27), consideradas estadísticamente significativas (p<0,001). En el análisis del tamaño del efecto, el estudio percibió mejor la variación en la variable ansiedad (η2p=0,74) que en las otras dos variables (η2p=0,14; η2p=0,23). Cirugía El estudio ofrece evidencias favorables para la efectividad del reiki en el control de la ansiedad preoperatoria de cirugías cardíacas. Registro Brasileiro de Ensaios Clínicos: RBR-2nhgvn6

Abstract Objective To assess the effectiveness of a Reiki protocol on anxiety levels in the preoperative period of cardiac surgery. Methods This is a controlled and randomized clinical trial carried out in a university reference hospital in cardiology between June and December 2021. Chunk randomization and allocation by draw with opaque sealed envelopes were carried out in two groups: Control (n=44; not subjected to intervention); and Intervention (n=44; submitted to two Reiki sessions three days before and the day before surgery). The main outcomes (anxiety, well-being and muscle tension) were assessed across sessions using a mixed effects model. To assess the effect size, partial eta squared (η2p) values were calculated. Results Differences in anxiety scores (+2.7 points more than the control), well-being (-0.78) and muscle tension (1.27) were determined, being considered statistically significant (p<0.001). In analyzing the effect size, the experiment better distinguished the variation in the anxiety variable (η2p=0.74) than in the other two variables (η2p=0.14; η2p=0.23). Conclusion The study offers favorable evidence for the effectiveness of Reiki in controlling preoperative anxiety after cardiac surgery. Brazilian Clinical Trials Registry: RBR-2nhgvn6

Práticas integrativas e complementares em saúde entre estudantes universitários: motivos de uso e de não uso / Integrative and complementary health practices among university students: reasons for use or non-use

Resumo O objetivo deste estudo é compreender os motivos de uso e não uso das práticas integrativas e complementares entres estudantes universitários da área da saúde. Trata-se de uma pesquisa quanti-qualitativa, com dados coletados por meio de questionários (667) e entrevistas (34) e submetidos à análise de conteúdo. Os efeitos terapêuticos, a influência familiar e a oferta de alternativa à biomedicina foram as principais razões elencadas para o uso das práticas integrativas e complementares, ao tempo que a ausência de demanda, o desinteresse e a falta de oportunidade foram as motivações mais frequentes para o não uso. Nesse sentido, as motivações de uso enfatizam as vantagens obtidas através da interlocução com essas práticas e alguns contextos que determinam sua adoção. Em relação às motivações de não uso, destaca-se um cenário de baixa oferta e dominância da biomedicina na cultura ocidental contemporânea. Portanto, esses resultados corroboram a demanda de enfrentamento da monocultura da biomedicina, bem como a abordagem das práticas integrativas na educação superior. Desse modo, a universidade pode se construir a partir da tessitura entre diferentes culturas em saúde, com a facilitação do emprego das práticas não hegemônicas e a ampliação das bases epistêmicas de cuidado na formação e vida da comunidade acadêmica.

Abstract The objective of this study is to understand the reasons for use or non-use of the integrative and complementary practices among university health students. It is a quantitative and qualitative research, with data collected with questionnaires (667) and interviews (34), and investigated by content analysis. Therapeutic effects, family influence, and offer of alternatives to biomedicine were the main reasons for use of integrative and complementary practices, while the absence of demand, disinterest, and lack of opportunity were the most frequent barriers for use. Therefore, the motivations for use emphasize advantages obtained with these practices and some contexts that determine their adoption. Regarding the barriers for use, a scenario of low availability and dominance of biomedicine in contemporary western culture stands out. Therefore, these results corroborate the demand to confront the monoculture of biomedicine, as well as the inclusion of integrative practices in higher health education. Thus, university can be built on dialogues between different cultures in health, facilitating the use of non-hegemonic practices and expanding the epistemic bases of care in the formation and the life of the academic community.