Impact of perioperative low-molecular-weight heparin therapy on clinical events of elderly patients with prior coronary stents implanted > 12 months undergoing non-cardiac surgery: a randomized, placebo-controlled trial.

BACKGROUND: Little is known about the safety and efficacy of discontinuing antiplatelet therapy via LMWH bridging therapy in elderly patients with coronary stents implanted for > 12 months undergoing non-cardiac surgery. This randomized trial was designed to compare the clinical benefits and risks of antiplatelet drug discontinuation via LMWH bridging therapy. METHODS: Patients were randomized 1:1 to receive subcutaneous injections of either dalteparin sodium or placebo. The primary efficacy endpoint was cardiac or cerebrovascular events. The primary safety endpoint was major bleeding. RESULTS: Among 2476 randomized patients, the variables (sex, age, body mass index, comorbidities, medications, and procedural characteristics) and percutaneous coronary intervention information were not significantly different between the bridging and non-bridging groups. During the follow-up period, the rate of the combined endpoint in the bridging group was significantly lower than in the non-bridging group (5.79% vs. 8.42%, p = 0.012). The incidence of myocardial injury in the bridging group was significantly lower than in the non-bridging group (3.14% vs. 5.19%, p = 0.011). Deep vein thrombosis occurred more frequently in the non-bridging group (1.21% vs. 0.4%, p = 0.024), and there was a trend toward a higher rate of pulmonary embolism (0.32% vs. 0.08%, p = 0.177). There was no significant difference between the groups in the rates of acute myocardial infarction (0.81% vs. 1.38%), cardiac death (0.24% vs. 0.41%), stroke (0.16% vs. 0.24%), or major bleeding (1.22% vs. 1.45%). Multivariable analysis showed that LMWH bridging, creatinine clearance < 30 mL/min, preoperative hemoglobin < 10 g/dL, and diabetes mellitus were independent predictors of ischemic events. LMWH bridging and a preoperative platelet count of < 70 × 109/L were independent predictors of minor bleeding events. CONCLUSIONS: This study showed the safety and efficacy of perioperative LMWH bridging therapy in elderly patients with coronary stents implanted > 12 months undergoing non-cardiac surgery. An alternative approach might be the use of bridging therapy with half-dose LMWH. TRIAL REGISTRATION: ISRCTN65203415.

Sodium-glucose cotransporter-2 inhibitors use and the risk of gout: a systematic review and meta-analysis.

Objective: To assess the relationship between use of sodium-glucose cotransporter-2 inhibitors (SGLT2i) and the risk of gout among patients with type 2 diabetes mellitus (T2DM). Methods: A systemic review and meta-analysis were designed by reviewing articles published between 2000 January 1 and 2022 December 31 using PubMed system and Web of Science system based on the PRISMA 2020 guidelines. The end point of interest was gout (including gout flares, gout events, starting uric-acid lowering therapy and starting anti-gout drugs use) among patients with T2DM using SGLT2i versus not using SGLT2i. A random-effects model was utilized to measure the pooled hazard ratio (HR) with 95% confidence interval (CI) for the risk of gout associated with SGLT2i use. Results: Two prospective post-hoc analyses of randomized controlled trials and 5 retrospective electronic medical record-linkage cohort studies met the inclusion criteria. The meta-analysis demonstrated that there was a decreased risk of developing gout for SGLT2i use as comparing with non-use of SGLT2i among patients with T2DM (pooled HR=0.66 and 95%CI=0.57-0.76). Conclusions: This meta-analysis demonstrates that SGLT2i use is associated with a 34% decreased risk of developing gout among patients with T2DM. SGLT2i may be the treatment options for patients with T2DM who are at high risk of gout. More randomized controlled trials and real-world data are needed to confirm whether there is a class effect of SGLT2i for the risk reduction of gout among patients with T2DM.

Efficacy of thiamine supplementation in improving depressive symptoms-evidence-based review / Eficacia de la suplementación con tiamina para mejorar los síntomas depresivos-revisión basada en la evidencia

Objetivos: Revisar la evidencia existente con respecto a la efectividad de la suplementación con tiamina en pacientes consíntomas depresivos en cuanto a su mejoría, en comparación con la toma de fármacos psicotrópicos aislados o placebos. Diseño: Revisión sistemática; Emplazamiento: Atención primaria. Método: Pregunta de investigación: Población – Adultos con síntomas depresivos; Intervención – Suplementación contiamina aislada o asociada a psicofármacos; Comparación: uso de placebo o fármacos psicotrópicos; Resultado – Mejoría delos síntomas depresivos (según DSM-V). La búsqueda se realizó utilizando los términos MeSH (("Depression" OR"Depression Disorder") AND "Thiamine"”) en las fuentes seleccionadas. Se excluyeron todos los artículos de opinión,artículos de revisión clásicos y estudios ya incluidos en metanálisis o revisiones sistemáticas seleccionadas. Se utilizó laescala Strength of Recommendation Taxonomy (SORT) para asignar niveles de evidencia y fuerzas de recomendación.Resultados: La investigación resultó en 3 artículos que cumplieron con los criterios de inclusión y de los cuales se extrajeronlas conclusiones.Conclusiones: Se demostraron beneficios estadísticamente significativos de la suplementación con tiamina en algunos delos parámetros evaluados. Sin embargo, a la suplementación con tiamina se le asignó una Fuerza de Recomendación B porla Escala SORT, ya que los estudios existentes de calidad moderada son pocos, aunque orientados al paciente, y no handemostrado ser suficientes o consistentes para recomendar la generalización del uso de tiamina. Se necesitan más ensayosclínicos controlados de buena calidad científica para responder adecuadamente a esta pregunta de investigación.(AU)

Objective: to review the existing evidence regarding the effectiveness of thiamine supplementation in improving depressivesymptoms in adult patients, compared to taking psychoactive drugs alone or placebo. Design: Systematic ReviewSite: Primary Care. Methods: Research question: Population – Adults with depressive symptoms; Intervention – Thiamine supplementationalone or associated with psychotropic drugs; Comparison: use of placebo or psychotropic drugs; Outcome – Improvementof depressive symptoms (according to DSM-V). The search was performed using the MeSH terms (("Depression" OR"Depression Disorder") AND "Thiamine"") in the selected sources. All opinion articles, classic review articles, and studiesalready included in meta-analyses or previously selected reviews were excluded. The strength of recommendationtaxonomy scale (SORT) was used to assign levels of evidence and strength of recommendation.Results: The search resulted in 3 articles that met the inclusion criteria, from which conclusions were drawn. Conclusions: Statistically significant benefits of thiamine supplementation were demonstrated in some of the evaluatedparameters. However, thiamine supplementation was assigned a Strength of Recommendation B by the SORT Scale, asexisting studies of moderate quality are few, albeit patient oriented, not proving to be sufficient or consistent torecommend the generalization of the use of thiamine. More controlled clinical trials of good scientific quality are needed toadequately answer this research question.(AU)

Prednisone vs Placebo and Live Birth in Patients With Recurrent Implantation Failure Undergoing In Vitro Fertilization: A Randomized Clinical Trial.

Importance: Implantation failure remains a critical barrier to in vitro fertilization. Prednisone, as an immune-regulatory agent, is widely used to improve the probability of implantation and pregnancy, although the evidence for efficacy is inadequate. Objective: To determine the efficacy of 10 mg of prednisone compared with placebo on live birth among women with recurrent implantation failure. Design, Setting, and Participants: A double-blind, placebo-controlled, randomized clinical trial conducted at 8 fertility centers in China. Eligible women who had a history of 2 or more unsuccessful embryo transfer cycles, were younger than 38 years when oocytes were retrieved, and were planning to undergo frozen-thawed embryo transfer with the availability of good-quality embryos were enrolled from November 2018 to August 2020 (final follow-up August 2021). Interventions: Participants were randomized (1:1) to receive oral pills containing either 10 mg of prednisone (n = 357) or matching placebo (n = 358) once daily, from the day at which they started endometrial preparation for frozen-thawed embryo transfer through early pregnancy. Main Outcomes and Measures: The primary outcome was live birth, defined as the delivery of any number of neonates born at 28 or more weeks' gestation with signs of life. Results: Among 715 women randomized (mean age, 32 years), 714 (99.9%) had data available on live birth outcomes and were included in the primary analysis. Live birth occurred among 37.8% of women (135 of 357) in the prednisone group vs 38.8% of women (139 of 358) in the placebo group (absolute difference, -1.0% [95% CI, -8.1% to 6.1%]; relative ratio [RR], 0.97 [95% CI, 0.81 to 1.17]; P = .78). The rates of biochemical pregnancy loss were 17.3% in the prednisone group and 9.9% in the placebo group (absolute difference, 7.5% [95% CI, 0.6% to 14.3%]; RR, 1.75 [95% CI, 1.03 to 2.99]; P = .04). Of those in the prednisone group, preterm delivery occurred among 11.8% and of those in the placebo group, 5.5% of pregnancies (absolute difference, 6.3% [95% CI, 0.2% to 12.4%]; RR, 2.14 [95% CI, 1.00 to 4.58]; P = .04). There were no statistically significant between-group differences in the rates of biochemical pregnancy, clinical pregnancy, implantation, neonatal complications, congenital anomalies, other adverse events, or mean birthweights. Conclusions and Relevance: Among patients with recurrent implantation failure, treatment with prednisone did not improve live birth rate compared with placebo. Data suggested that the use of prednisone may increase the risk of preterm delivery and biochemical pregnancy loss. Our results challenge the value of prednisone use in clinical practice for the treatment of recurrent implantation failure. Trial Registration: Chinese Clinical Trial Registry Identifier: ChiCTR1800018783.

Efficacy and safety of adding fluoxetine to the treatment regimen of hospitalized patients with non-critical COVID-19 pneumonia: A double-blind randomized, placebo-controlled clinical trial.

INTRODUCTION: Selective serotonin reuptake inhibitors are considered the drugs, whose effectiveness in viral pandemics has been studied. The aim of this study was to evaluate of adding fluoxetine to the treatment regimen of patients with COVID-19 pneumonia. METHODS: This study was a double-blind randomized placebo controlled clinical trial .36 patients in the fluoxetine and 36 patients in the placebo group were enrolled. Patients in the intervention group were first treated with fluoxetine 10 mg for 4 days and then the dose of 20 mg was continued for 4 weeks. Data analysis was conducted using SPSS V. 22.0. RESULTS: There was no statistically significant difference between the two groups in terms of clinical symptoms at the beginning of the study and also the score of anxiety and depression, oxygen saturation at the time of hospitalization, mid-hospitalization and discharge periods. The need for mechanical ventilator support (p = 1.00), the need for admission in the intensive care unit (ICU) (p = 1.00), rate for mortality (p = 1.00), and discharge with relative recovery (p = 1.00) were not significantly different between the two groups. The distribution of CRP within the study groups showed a significant decrease during different time periods (p = 0.001), and although there was no statistically significant difference between the two groups on the first day (p = 1.00) and at discharge (p = 0.585), mid-hospital CRP showed a significant decrease in the fluoxetine group (p = 0.032). CONCLUSION: Fluoxetine resulted in a faster reduction of patients' inflammation without association with depression and anxiety.

Adjuvant Osimertinib vs. Placebo in Completely Resected Stage IA2-IA3 EGFR-Mutated NSCLC: ADAURA2.

INTRODUCTION: Osimertinib is a third-generation, irreversible, oral epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) that potently and selectively inhibits both EGFR-TKI sensitizing and EGFR T790M resistance mutations, with demonstrated efficacy in EGFR mutation-positive (EGFRm) non-small cell lung cancer (NSCLC), including central nervous system (CNS) metastases. Here we present the rationale and study design for ADAURA2 (NCT05120349), which will evaluate adjuvant osimertinib vs. placebo in patients with stage IA2-IA3 EGFRm NSCLC, following complete tumor resection. PATIENTS AND METHODS: ADAURA2 is a phase III, global, randomized, double-blind, placebo-controlled study. Patients will be adults aged ≥18 years with resected primary nonsquamous NSCLC stage IA2 or IA3 and central confirmation of an EGFR exon 19 deletion or L858R mutation. Patients will be stratified by pathologic risk of disease recurrence (high vs. low), EGFR mutation type (exon 19 deletion vs. L858R) and race (Chinese Asian vs. non-Chinese Asian vs. non-Asian), and randomized 1:1 to receive osimertinib 80 mg once daily (QD) or placebo QD until disease recurrence, treatment discontinuation, or a maximum treatment duration of 3 years. The primary endpoint of this study is disease-free survival (DFS) in the high-risk stratum. Secondary endpoints include DFS in the overall population, overall survival, CNS DFS, and safety. Health-related quality of life and pharmacokinetics will also be evaluated. RESULTS: Study enrolment began in February 2022 and interim results of the primary endpoint are expected in August 2027.

Estrógeno potenciado en el tratamiento homeopático del dolor pélvico asociado a endometriosis: un estudio aleatorizado, doble ciego, controlado con placebo, de 24 semanas / Potentiated estrogen in the homeopathic treatment of pelvic pain associated with endometriosis: a 24-week randomized, double-blind, placebo-controlled study

Evaluar la eficacia y seguridad del estrógeno potenciado en comparación con el placebo en el tratamiento homeopático del dolor pélvico asociado a endometriosis (EAPP, por sus siglas en inglés). Diseño del estudio: El presente fue un estudio clínico aleatorizado, doble ciego, controlado con placebo, de 24 semanas, el cual incluyó a 50 mujeres de entre 18 y 45 años de edad con diagnóstico de endometriosis infiltrante profunda con base en ultrasonido transvaginal o imágenes de resonancia magnética después de preparación intestinal, así como puntaje ≥ 5 en una escala visual analógica (VAS: rango de 0 a 10 puntos) para el dolor pélvico asociado con la endometriosis. Se administró estrógeno potenciado (12cH, 18cH y 24cH) o placebo dos veces al día por vía oral. La medida principal de resultado fue el cambio en la severidad de los puntajes parcial y global de EAPP (VAS) de la línea basal a la semana 24, determinada como la diferencia en el puntaje medio de cinco modalidades de dolor pélvico crónico (dismenorrea, dispareunia profunda, dolor pélvico no cíclico, dolor intestinal cíclico y/o dolor urinario cíclico). Las medidas secundarias de resultado fueron la diferencia media de puntaje para la calidad de vida evaluada con el Cuestionario de Salud SF-36, los síntomas de depresión en el Inventario de la Depresión de Beck (BDI) y los síntomas de ansiedad en el Inventario de Ansiedad de Beck (BAI). Resultados: El puntaje global de EAPP (VAS: rango de 0 a 50 puntos) se redujo en 12.82 (p < 0.001) en el grupo tratado con estrógeno potenciado de la línea basal a la semana 24. El grupo que utilizó estrógeno potenciado también presentó una reducción en el puntaje parcial (VAS: rango de 0 a 10 puntos) en tres modalidades de EAPP: dismenorrea (3.28; p < 0.001), dolor pélvico no cíclico (2.71; p = 0.009) y dolor intestinal cíclico (3.40; p < 0.001). El grupo de placebo no mostró cambio significativo alguno en los puntajes global o parcial de EAPP. Además, el grupo de estrógeno potenciado mostró un mejoramiento significativo en tres de ocho ámbitos de SF-36 (dolor de cuerpo, vitalidad y salud mental) y síntomas de depresión (BDI). El grupo de placebo no mostró un mejoramiento significativo a este respecto. Estos resultados demuestran la superioridad del estrógeno potenciado sobre el placebo. Se asociaron pocos eventos adversos con el estrógeno potenciado. Conclusiones: El estrógeno potenciado (12cH, 18cH y 24cH) en dosis de 3 gotas dos veces al día durante 24 semanas fue significativamente más efectivo que el placebo para reducir el dolor pélvico asociado con la endometriosis. Registro del estudio clínico: ClinicalTrials.gov Identificador: https://clinicaltrials.gov/show/NCT02427386.

To evaluate the efficacy and safety of potentized estrogen compared to placebo in homeopathic treatment of endometriosis-associated pelvic pain (EAPP). Study design: The present was a 24-week, randomized, doubleblind, placebocontrolled trial that included 50 women aged 18-45 years old with diagnosis of deeply infiltrating endometriosis based on magnetic resonance imaging or transvaginal ultrasound after bowel preparation, and score ≥ 5 on a visual analogue scale (VAS: range 0 to 10 points) for endometriosis-associated pelvic pain. Potentized estrogen (12cH, 18cH and 24cH) or placebo was administered twice daily per oral route. The primary outcome measure was change in the severity of EAPP global and partial scores (VAS) from baseline to week 24, determined as the difference in the mean score of five modalities of chronic pelvic pain (dysmenorrhea, deep dyspareunia, non-cyclic pelvic pain, cyclic bowel pain and/or cyclic urinary pain). The secondary outcome measures were mean score difference for quality of life assessed with SF-36 Health Survey Questionnaire, depression symptoms on Beck Depression Inventory (BDI), and anxiety symptoms on Beck Anxiety Inventory (BAI). Results: The EAPP global score (VAS: range 0 to 50 points) decreased by 12.82 (p < 0.001) in the group treated with potentized estrogen from baseline to week 24. Group that used potentized estrogen also exhibited partial score (VAS: range 0 to 10 points) reduction in three EAPP modalities: dysmenorrhea (3.28; p < 0.001), non-cyclic pelvic pain (2.71; p = 0.009), and cyclic bowel pain (3.40; p < 0.001). Placebo group did not show any significant changes in EAPP global or partial scores. In addition, the potentized estrogen group showed significant improvement in three of eight SF-36 domains (bodily pain, vitality and mental health) and depression symptoms (BDI). Placebo group showed no significant improvement in this regard. These results demonstrate superiority of potentized estrogen over placebo. Few adverse events were associated with potentized estrogen. Conclusions: Potentized estrogen (12cH, 18cH and 24cH) at a dose of 3 drops twice daily for 24 weeks was significantly more effective than placebo for reducing endometriosis-associated pelvic pain.

Expensive seems better: The price of a non-effective drug modulates its perceived efficacy.

Previous studies have shown that the price of a given product impacts the perceived quality of such product. This finding was also observed in medical contexts, showing that expensive drugs increase the placebo effect compared to inexpensive ones. However, addressing a drug's efficacy requires making causal inferences between the drug and the healing. These inferences rely on the contingency between these two events, a factor that is difficult to control in the placebo research. The present study aimed to test whether the price of a given drug modulates its perceived efficacy using a proper (though fictitious) non-effective drug, so that not only the objective contingency, but also the probability of the cause and the probability of the effect could be adequately controlled for. We expected higher efficacy judgements for the expensive non-effective drug than for the inexpensive one. To test this hypothesis, 60 volunteers participated in a contingency learning task that was programmed so that 72% of the patients healed regardless of whether they took the drug. Approximately one-half of the participants were told that the drug was expensive, whereas the other half were told that it was inexpensive. As expected, the efficacy judgements of participants who saw the expensive drug were significantly higher than those who saw the inexpensive one. Overall, our results showed that the price of a non-effective drug modulates its perceived efficacy, an effect that seems to be mediated by the estimated number of doses administered. This result parallels findings in the placebo literature but using a laboratory methodology that allows stronger control of the variables, suggesting that the illusory overestimation produced by the more expensive treatments might be on the basis of the greater efficacy of the more expensive placebos.

Analysis of serum microRNA-122 in a randomized controlled trial of N-acetylcysteine for treatment of antituberculosis drug-induced liver injury.

AIM: Serum microRNA-122 (miR-122) is a novel biomarker for drug-induced liver injury, with good sensitivity in the early diagnosis of paracetamol-induced liver injury. We describe miR-122 concentrations in participants with antituberculosis drug-induced liver injury (AT-DILI). We explored the relationship between miR-122 and alanine aminotransferase (ALT) concentrations and the effect of N-acetylcysteine (NAC) on miR-122 concentrations. METHODS: We included participants from a randomized placebo-controlled trial of intravenous NAC in AT-DILI. ALT and miR-122 concentrations were quantified before and after infusion of NAC/placebo. We assessed correlations between ALT and miR-122 concentrations and described changes in ALT and miR-122 concentrations between sampling occasions. RESULTS: We included 45 participants; mean age (± standard deviation) 38 (±10) years, 58% female and 91% HIV positive. The median (interquartile range) time between pre- and post-infusion biomarker specimens was 68 h (47-77 h). The median pre-infusion ALT and miR-122 concentrations were 420 U/L (238-580) and 0.58 pM (0.18-1.47), respectively. Pre-infusion ALT and miR-122 concentrations were correlated (Spearman's ρ = .54, P = .0001). Median fold-changes in ALT and miR-122 concentrations between sampling were 0.56 (0.43-0.69) and 0.75 (0.23-1.53), respectively, and were similar in the NAC and placebo groups (P = .40 and P = .68 respectively). CONCLUSIONS: miR-122 concentrations in our participants with AT-DILI were considerably higher than previously reported in healthy volunteers and in patients on antituberculosis therapy without liver injury. We did not detect an effect of NAC on miR-122 concentrations. Further research is needed to determine the utility of miR-122 in the diagnosis and management of AT-DILI.

Usefulness of the placebo lead-in design for clinical trials with binary outcomes.

BACKGROUND: In placebo-controlled clinical trials to develop new drugs for the treatment of psychiatric or neurological disorders, a high and sometimes greater-than-expected placebo response makes it difficult to show the superiority of an investigational drug over a corresponding placebo. To avoid such difficulty, a placebo lead-in design has been presented, but its usefulness has been open to discussion. Although the statistical properties of the placebo lead-in design are investigated in the context of continuous outcomes, whether these properties can be generalized for binary or ordinal cases remains unclear. METHODS: We investigate whether the placebo lead-in design is useful in clinical trials with binary outcomes through mathematical formulae and a numerical investigation. Specifically, we compare the proportion of placebo responders, the drug-placebo difference, and the effect size between two populations: one enriched for placebo nonresponders and the other comprising the all-comers. RESULTS: Under positive correlation of the data between the lead-in stage and the randomized stage for both treatment groups, we mathematically show that the proportion of responders in the population enriched for placebo nonresponders is less than that in the all-comers population, and whether the placebo lead-in design increases the drug-placebo difference depends on the variances of outcomes in both treatment groups as well as the correlations of the outcomes between two stages. Further, through a numerical investigation, we show that whether the placebo lead-in design increases the effect size strongly depends on the magnitude of the correlations and their difference. CONCLUSION: If the correlation of the placebo-placebo group is much higher than that of the placebo-drug group, the placebo lead-in design is advantageous in most cases but has an impact on an estimand in placebo nonresponders. Therefore, we do not recommend using the placebo lead-in design for clinical trials with binary outcomes.

Undisclosed Placebo Trials in Clinical Practice: Undercover Beneficence or Unwarranted Deception?

A placebo is an intervention that is believed to lack specific pharmacological or physiological efficacy for a patient's condition. While placebo-controlled trials are considered the gold standard when it comes to researching and testing new pharmacological treatments, the use of placebos in clinical practice is more controversial. The focus of this case study is an undisclosed placebo trial used as an attempt to diagnose a patient's complex and unusual symptomology. In this case, the placebo was used not just as a treatment, but as a diagnostic intervention in order to determine the best course of treatment for a patient. Could the deceptive use of a placebo be justified in clinical practice on the grounds of beneficence?

Placebos and Metaphors.

The objective of this essay is to develop the argument that placebos are a species of metaphor and to demonstrate that an analysis of the figurative trope can help us elucidate the power of the placebo response. The cognitive and embodied responses to both metaphors and placebos stem from the transfer of meaning between two domains, each with rich allusive properties that in turn depend on highly ramified and interconnected neural webs. Metaphors and placebos require an appropriate cultural backdrop for their linguistic and cognitive work and are dependent on shared social forms of life. More specifically, metaphors rely on an intersubjective connection and imply that a relational entanglement between doctor and patient is necessary to the effect of placebos in the clinical setting.

Baru nuts reduce abdominal adiposity in type 2 diabetic adults: a randomized, placebo-controlled, crossover trial / Amêndoa de baru reduz a adiposidade abdominal de adultos com diabetes Mellitus tipo 2: um estudo randomizado, placebo-controlado, crossover

ABSTRACT Objective: This study aimed to evaluate the effect of baru nuts supplementation on body composition and metabolic profile in adults with type 2 diabetes. Methods: This is a randomized, placebo-controlled, crossover trial with 30 adults with type 2 diabetes. The assay had two periods of 12 weeks each, with a washout period of 12 weeks between treatments. The subjects were randomized and received the two treatments in alternate periods: supplementation of 30g baru nuts or placebo. Anthropometry, body composition, blood pressure, blood sampling, food intake, and physical activity data were analyzed. Results: Baru nut intake reduced waist circumference (p=0.032), compared to placebo group. In the intra-group analysis, baru nut intake reduced total cholesterol (p=0.012) and LDL-c (p=0.017). Conclusion: The daily intake of baru nuts improved abdominal adiposity. Therefore, these nuts should be included in the diet to improve the health status of adults with type 2 diabetes.

RESUMO: Objetivo: Avaliar o efeito da suplementação com amêndoa de baru sobre a composição corporal e perfil metabólico de adultos com diabetes Mellitus tipo 2. Métodos: Este é um estudo randomizado, placebo-controlado, crossover com 30 adultos com diabetes Mellitus tipo 2. O ensaio clínico foi dividido em dois períodos de 12 semanas cada, com um washout de 12 semanas entre os tratamentos. Os sujeitos foram randomizados e receberam dois tratamentos em períodos alternativos: suplementação com 30 g de amêndoa de baru ou placebo. Foram coletados dados referentes à antropometria, composição corporal, pressão arterial, amostras de sangue, ingestão de alimentos e práticas de atividade física. Resultados: A ingestão de amêndoa de baru reduziu a circunferência da cintura (p=0,032), em comparação com o grupo placebo. Na análise intragrupo, a ingestão de amêndoa de baru também reduziu o colesterol total (p=0,012) e LDL-c (p=0,017). Conclusão: A ingestão diária de amêndoa de baru melhorou a adiposidade abdominal, portanto, deve ser incluída na dieta para a melhora do estado de saúde de adultos com diabetes Mellitus tipo 2.

Evaluation of the effect of melatonin in patients with Burning mouth syndrome: a double-blind, placebo-controlled randomized clinical trial

Abstract The present study was carried out to evaluate the effect of Melatonin and Placebo in the patient with the Burning mouth (BMs). This double-blind, placebo-controlled randomized clinical trial study was carried out on 30 patients who were suffering from BMS. During this period patients were divided into 2 study and control groups. The study group used four 3 mg Melatonin daily and the control group received a placebo. Then the severity of the burning sensation was measured by the physician Sleep quality was measured using the VAS scale using the Petersburg questionnaire. Data in the application Enter SPSS 20 and then using T test or equivalent Nonparametric was analyzed, mean sleep score and mean severity of oral irritation before and after treatment in two the group was evaluated using T-test Independent. Level significance was considered 0.05. The results of the present study show that the use of melatonin and a placebo in patients with BMS reduces sensation and improves their sleep quality, although it may not reduce it completely. In this study severity of burning was 4.93±2.56 after treatment in the study group and 6.93±2.12 in the control group, which was statistically significant (P =0.036). No significant difference was observed between the two groups in the sleep quality score (P-value = 0.43). Using Melatonin can be a reliable way to treat pain for which there is no standard treatment to date. Although evidence suggests an association between sleep disorders and BMS, melatonin was not superior to a placebo in reducing BMS-induced burning in the present study. Identification of stressors and the ways to struggle with them, further studies with larger samples and higher oral doses, extended follow-up periods and control of psychological factors, and measurement of body mass index that may affect pharmacokinetics are recommended.

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.