RESUMEN
INTRODUCTION: Renal denervation has been associated with substantial and sustained blood pressure reduction and is considered to serve as an alternative treatment for patients with resistant hypertension. However, the first published SHAM-controlled trial assessing RDN safety and efficacy showed no difference between groups. AIM: We aimed to perform a meta-analysis quantifying the magnitude of blood pressure decrease secondary to renal denervation in patients with resistant hypertension. METHODS: Databases were searched for RCTs that compared RDN therapy to SHAM procedure and reported the outcomes of (1) 24-hour ambulatory blood pressure; (2) Office systolic blood pressure; (3) Daytime systolic blood pressure; and (4) Night-time systolic blood pressure. Mean differences with 95% confidence intervals (CIs) were calculated using a random-effects model. Heterogeneity was examined with I² statistics. P values of < 0.05 were considered statistically significant. Statistical analyses were performed using RStudio 4.2.3. RESULTS: Nine studies and 1622 patients were included. The AMBP [MD -3.72 95%CI -5.44, -2.00 p < 0.001; I²=34%] and DSBP [MD -4.10 95%CI -5.84, -2.37 p < 0.001; I²=0%] were significantly reduced in the RDN arm. ODBP [MD -6.04 95%CI -11.31, -0.78 p = 0.024; I²=90%] and NSBP [MD -1.81 95%CI -3.90, 0.27 p = 0.08; I²=0%] did not reach a statistically significant difference between groups. CONCLUSION: Renal denervation demonstrates greater efficacy in reducing 24-hour ambulatory and daytime systolic blood pressure in patients diagnosed with resistant hypertension.
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Placebos , Terapéutica , Hipertensión , Presión Sanguínea , DesnervaciónRESUMEN
The DESIRE Study (MTN-035) explored product preference among three placebo rectal microbicide (RM) formulations, a rectal douche (RD), a suppository, and an insert, among 210 sexually active transgender people and men who have sex with men in five counties: the United States, Peru, Thailand, South Africa, and Malawi. Participants used each product prior to receptive anal sex (RAS) for 1 month, following a randomly assigned sequence, then selected their preferred product via computer assisted self-interview. In-depth interviews examined reasons for preference. We compared product preference and prior product use by country to explore whether geographic location and experience with the similar products impacted preference. A majority in the United States (56%) and Peru (58%) and nearly half in South Africa (48%) preferred the douche. Most in Malawi (59%) preferred the suppository, while half in Thailand (50%) and nearly half in South Africa (47%) preferred the insert. Participants who preferred the douche described it as quick and easy, already routinized, and serving a dual purpose of cleansing and protecting. Those who preferred the insert found it small, portable, discreet, with quick dissolution. Those who preferred the suppository found the size and shape acceptable and liked the added lubrication it provided. Experience with product use varied by country. Participants with RD experience were significantly more likely to prefer the douche (p = 0.03). Diversifying availability of multiple RM dosage forms can increase uptake and improve HIV prevention efforts globally.
RESUMEN: El estudio DESIRE (MTN-035) exploró la preferencia de producto entre tres formulaciones de microbicida rectal (MR) de placebo, una ducha rectal, un supositorio y un inserto, entre 210 personas transgénero y hombres que tienen sexo con hombres en cinco países: los Estados Unidos, Perú., Tailandia, Sudáfrica y Malawi. Los participantes utilizaron cada producto antes del sexo anal receptive (SAR) durante un mes, siguiendo una secuencia asignada al azar, luego seleccionaron su producto preferido mediante una autoentrevista asistida por computadora. Las entrevistas en profundidad examinaron los motivos de preferencia. Comparamos la preferencia de producto y el uso previo del producto por país para explorar si la ubicación geográfica y la experiencia con la forma farmacéutica impactaron la preferencia. Una mayoría en los Estados Unidos (56%) y Perú (58%) y casi la mitad en Sudáfrica (48%) prefirieron la ducha rectal. La mayoría en Malawi (59%) prefirió el supositorio, mientras que la mitad en Tailandia (50%) y casi la mitad en Sudáfrica (47%) prefirió el inserto. Los participantes que prefirieron la ducha rectal la describieron como rápida y fácil, ya parte de su rutina y que tenía el doble propósito de limpiar y proteger. Los que prefirieron el inserto lo consideraron pequeño, portátil, discreto y de rápida disolución. Los que prefirieron el supositorio encontraron que tenía un tamaño y forma aceptables y proveía lubricación adicional. La experiencia con el uso del producto varió según el país. Los participantes con experiencia con duchas rectales tenían significativamente más probabilidades de preferir la ducha rectal (p = 0,03). Diversificar la disponibilidad de múltiples formas farmacéuticas de MR puede aumentar la aceptación y mejorar los esfuerzos de prevención del VIH a nivel mundial.
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Administración Rectal , Infecciones por VIH , Homosexualidad Masculina , Minorías Sexuales y de Género , Humanos , Masculino , Tailandia , Infecciones por VIH/prevención & control , Malaui , Minorías Sexuales y de Género/psicología , Estados Unidos , Adulto , Femenino , Adulto Joven , Sudáfrica , Homosexualidad Masculina/psicología , Supositorios , Adolescente , Perú , Prioridad del Paciente , Conducta Sexual , Personas Transgénero/psicología , Antiinfecciosos/administración & dosificación , Placebos/administración & dosificación , Formas de DosificaciónRESUMEN
Importance: Matched placebo interventions are complex and resource intensive. Recent evidence suggests matched placebos may not always be necessary. Previous studies have predominantly evaluated potential bias of nonmatched placebos (ie, differing on dose, frequency of administration, or formulation) in pain and mental health, but to date no systematic examination has been conducted in infectious disease. Objective: To test for differences between nonmatched and matched placebo arms with respect to clinical outcome measures across multiple therapeutics for COVID-19. Design, Setting, and Participants: In a comparative effectiveness research study, a post hoc analysis was conducted of data on individual patients enrolled in a large, multiarm, platform randomized clinical trial in symptomatic adult outpatients with COVID-19 between January 15, 2021, to September 28, 2023, in which the outcomes of both matched and nonmatched placebo groups were reported. Bayesian and frequentist covariate-adjusted techniques were compared with 7 intervention-placebo pairs. Exposures: Seven matched and nonmatched placebo pairs (for a total of 7 comparisons) were evaluated throughout the primary platform trial. Comparisons were made between treatment and its associated matched (concurrent) placebo, as well as with nonmatched placebo (alone and in combination) assessed at a similar time point. Main Outcomes and Measures: Outcomes assessed included hospitalizations, EuroQol 5-Dimension 5-level scores, and PROMIS Global-10 scores. Results: A total of 7 intervention-control pairs (N = 2684) were assessed, including 1620 (60.4%) women, with mean (SD) age, 47 (15.2) years; the most common comorbidities were obesity (41.9%) and hypertension (37.9%). In a meta-analysis with decoupled SEs, accounting for overlapping placebo patients, the overall odds ratio (OR) of nonmatched compared with matched placebo was 1.01 (95% credible interval, 0.77-1.32), with posterior probability of equivalence, defined as 0.8 ≤ OR ≤ 1.2 (a deviation from perfect equivalence ie, OR = 1, by no more than 0.2) of 85.4%, implying no significant difference. Unadjusted analysis of the event rate difference between all nonmatched and matched placebo groups did not identify any notable differences across all 7 treatment-placebo combinations assessed. Similar analysis that was conducted for patient-reported quality of life outcomes did not yield statistically significant differences. Conclusions and Relevance: In this post hoc study of a randomized clinical platform trial, pooling matched and nonmatched placebo patient data did not lead to inconsistencies in treatment effect estimation for any of the investigational drugs. These findings may have significant implications for future platform trials, as the use of nonmatched placebo may improve statistical power, or reduce barriers to placebo implementation.
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Tratamiento Farmacológico de COVID-19 , COVID-19 , SARS-CoV-2 , Humanos , Femenino , Masculino , Persona de Mediana Edad , Placebos/uso terapéutico , Placebos/administración & dosificación , Adulto , Resultado del Tratamiento , Teorema de Bayes , Investigación sobre la Eficacia ComparativaRESUMEN
OBJECTIVE: To assess the protective effect of fluoride (F) gels supplemented with micrometric or nano-sized sodium trimetaphosphate (TMPmicro and TMPnano, respectively) against enamel erosion in vitro. METHODS: Bovine enamel blocks (n = 140) were selected according to their surface hardness, and randomly divided into seven groups (n = 20/group), according to the gels tested: Placebo (without F/TMP), 4,500 µg F/g (4500F), 9,000 µg F/g (9000F), 4500F plus 2.5 % TMPnano (2.5 % Nano), 4500F plus 5 % TMPnano (5 % Nano), 4500F plus 5 % TMPnano (Micro 5 %) and 12,300 µg F/g (Acid gel). Blocks were treated once during one minute with the gels, and submitted to erosive (ERO, n = 10/group) or erosive plus abrasive (ERO+ABR, n = 10/group) challenges 4 times/day, for 90 s for each challenge (under reciprocating agitation), during consecutive 5 days. Blocks were analyzed by profilometry, and by surface (SH) and cross-sectional hardness (∆KHN). Data were submitted to two-way ANOVA, and Fisher's LSD test (p < 0.05). RESULTS: For ERO, both TMPnano-containing gels promoted enamel wear significantly lower than Placebo and 4500F, reaching levels similar to both positive controls (9000F and acid gel); significantly lower softening was observed for enamel treated with 4500F+5 % Micro and 4500F+2.5 % Nano. Also, the lowest ∆KHN values were observed for 4500F+2.5 % TMPnano among the TMP-containing gels. For ERO+ABR, the lowest enamel wear was achieved by the use of 4500F+5 % Nano among all gels, including both positive controls; lower softening was observed for Placebo and 9000F groups. CONCLUSION: The addition of 5 % nano-sized TMP to a low-fluoride gel produced superior protective effects for enamel under both challenges conditions, when compared with micrometric TMP, reaching values similar to or superior than both positive controls, respectively for ERO and ERO+ABR. CLINICAL SIGNIFICANCE: The supplementation of low-F gels with TMP was shown to significantly improve their effects on enamel erosive wear, and the use of nano-sized TMP further enhances this protective action.
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Cariostáticos , Esmalte Dental , Geles , Dureza , Nanopartículas , Polifosfatos , Erosión de los Dientes , Animales , Bovinos , Esmalte Dental/efectos de los fármacos , Polifosfatos/farmacología , Erosión de los Dientes/prevención & control , Cariostáticos/farmacología , Cariostáticos/uso terapéutico , Distribución Aleatoria , Fluoruros/uso terapéutico , Placebos , Factores de TiempoRESUMEN
Homeopathy has been a medical practice recognized worldwide for more than two centuries, providing care, teaching, and research activities in several health institutions and medical schools. It employs a clinical approach based on non-conventional and complementary scientific principles (principle of therapeutic similitude, homeopathic pathogenetic experimentation, and use of dynamized doses and individualized medicines), with the aim of awakening a curative response from the body against its own disorders or diseases1. Homeopathy proposes to understand and treat the sick-disease binomial according to a vitalist, globalizing, and humanist anthropological approach, valuing the different aspects of the sick individuality (mental, general, and physical) and contributes to maintain health and organic homeostasis, acting as a therapeutic alternative for various health disorders2,3. However, to achieve this objective, homeopathic therapy must be well conducted and follow the epistemological premises of the homeopathic model1, among which include applying therapeutic similitude/similarity between the set of signs and symptoms of the sick individual (characteristic symptomatic totality of the sick-disease binomial) and the set of pathogenetic signs and symptoms caused by the medicine in the healthy individual (homeopathic pathogenetic experimentation), meaning individualized homeopathic treatment.
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Placebos , Terapéutica HomeopáticaRESUMEN
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.
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Humanos , Femenino , Adolescente , Adulto , Persona de Mediana Edad , Terapéutica Homeopática , Dolor Pélvico/terapia , Endometriosis/complicaciones , Estrógenos/uso terapéutico , Placebos , Método Doble CiegoRESUMEN
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.
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Humanos , Masculino , Femenino , Adulto , Persona de Mediana Edad , Adulto Joven , Composición Corporal , Dipteryx , Diabetes Mellitus Tipo 2/metabolismo , Placebos/uso terapéutico , Colesterol , Estudios Cruzados , Circunferencia Abdominal , Presión ArterialRESUMEN
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.
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Humanos , Masculino , Femenino , Pacientes/clasificación , Síndrome de Boca Ardiente/patología , Método Doble Ciego , Ensayo Clínico Controlado Aleatorio , Melatonina/efectos adversos , Placebos/efectos adversos , Encuestas y Cuestionarios/clasificaciónRESUMEN
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.
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Análisis de Sistemas , Dolor Musculoesquelético , Placebos , Modalidades de Fisioterapia , Efecto NoceboRESUMEN
INTRODUCTION: Tourette's Syndrome (TS) is a neurodevelopmental disorder characterized by motor and / or vocal tics for more than 12 months. TS affects about 0.8% of pediatric patients and is associated with great functional impairment and psychological distress. The present study aims to list and compare the effectiveness of therapies used in children and young people with TS. METHODS: PubMed / MEDLINE, Cochrane Library, ScienceDirect, SciELO and Lilacs were used from September 2020 to April 2021 to search for randomized clinical trials with pharmacological, behavioral, physical or alternative interventions for tics in children and young people with ST. RESULTS: 13 clinical trials were included, of which six pharmacological, six behavioral and one of other conformation. The global score on the Yale Global Tic Severity Scale showed evidence in favor of Habit Reversal Training (HRT) and Comprehensive Behavioral Intervention for Tics (CBIT). Evidence from two studies suggests that antipsychotic medications improve tic scores. Evidence from other interventions has shown no conclusive benefit. CONCLUSIONS: The present study identified benefits with the use of antipsychotics. The study also found that HRT and CBIT showed improvement in reducing the severity of tics, in addition to not having any adverse effects. These therapies showed significant clinical improvement, but there is no comparison between the use of these isolated approaches in relation to their use associated with medications. In view of the different forms of therapy, further studies are needed to identify the effectiveness and the profile of adverse effects of these interventions.
INTRODUÇÃO: A Síndrome de Tourette (ST) é um distúrbio do neurodesenvolvimento caracterizado por tiques motores e/ou vocais por mais de 12 meses. A ST afeta cerca de 0,8% dos pacientes pediátricos e associa-se a grande comprometimento funcional e sofrimento psíquico. O presente estudo tem como objetivo listar e comparar a eficácia das terapias utilizadas em crianças e jovens com ST. MÉTODOS: PubMed/MEDLINE, Cochrane Library, ScienceDirect, SciELO e Lilacs foram usados desde setembro de 2020 até abril de 2021 para a busca de ensaios clínicos randomizados com intervenções farmacológicas, comportamentais, físicas ou alternativas para tiques em crianças e jovens com ST. RESULTADOS: 13 ensaios clínicos foram incluídos, dos quais seis farmacológicos, seis comportamentais e um de outra conformação. A pontuação global na Yale Global Tic Severity Scale, apresentou evidências a favor do Treinamento de Reversão de Hábito (TRH) e Intervenção Comportamental Abrangente para Tiques (ICAT). As evidências de dois estudos sugerem que medicamentos antipsicóticos melhoram os escores de tiques. Evidências de outras intervenções não mostraram nenhum benefício conclusivo. CONCLUSÕES: O presente estudo identificou benefícios com o uso do antipsicóticos. O estudo também identificou que a TRH e a ICAT apresentaram melhora na redução da gravidade dos tiques, além de não apresentarem efeitos adversos. Essas terapias mostraram importante melhora clínica, mas não há comparação entre o uso dessas abordagens isoladas em relação ao seu uso associado com medicamentos. Diante das diferentes formas de terapia, mais estudos são necessários para identificar a eficácia e o perfil de efeitos adversos dessas intervenções.
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Humanos , Niño , Adolescente , Trastornos de Tic/terapia , Terapia Conductista , Síndrome de Tourette/diagnóstico , Síndrome de Tourette/tratamiento farmacológico , Placebos , Antipsicóticos/farmacología , Resultado del Tratamiento , Aripiprazol/farmacologíaRESUMEN
Neuropathic pain after brachial plexus injury (NPBPI) is a highly disabling clinical condition and is increasingly prevalent due to increased motorcycle accidents. Currently, no randomized controlled trials have evaluated the effectiveness of non-invasive brain stimulation techniques such as repetitive transcranial magnetic stimulation (rTMS) and transcranial direct-current stimulation (tDCS) in patients suffering from NPBPI. In this study, we directly compare the efficacy of 10-Hz rTMS and anodal 2 mA tDCS techniques applied over the motor cortex (5 daily consecutive sessions) in 20 patients with NPBPI, allocated into 2 parallel groups (active or sham). The order of the sessions was randomised for each of these treatment groups according to a crossover design and separated by a 30-day interval. Scores for "continuous" and "paroxysmal" pain (primary outcome) were tabulated after the last stimulation day and 30 days after. Secondary outcomes included the improvement in multidimensional aspects of pain, anxiety state and quality of life from a qualitative and quantitative approach. Active rTMS and tDCS were both superior to sham in reducing continuous (p < 0.001) and paroxysmal (p = 0.002; p = 0.02) pain as well as in multidimensional aspects of pain (p = 0.001; p = 0.002) and anxiety state (p = < 0.001; p = 0.005). Our results suggest rTMS and tDCS are able to treat NPBPI with little distinction in pain and anxiety state, which may promote the use of tDCS in brachial plexus injury pain management, as it constitutes an easier and more available technique.Clinical Trial Registration: http://www.ensaiosclinicos.gov.br/, RBR-5xnjbc - Sep 3, 2018.
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Ansiedad/terapia , Plexo Braquial/lesiones , Neuralgia/terapia , Estimulación Transcraneal de Corriente Directa/métodos , Estimulación Magnética Transcraneal/métodos , Adulto , Ansiedad/etiología , Ansiedad/psicología , Estudios Cruzados , Método Doble Ciego , Femenino , Humanos , Masculino , Neuralgia/diagnóstico , Neuralgia/etiología , Neuralgia/psicología , Manejo del Dolor/métodos , Dimensión del Dolor/estadística & datos numéricos , Proyectos Piloto , Placebos , Calidad de Vida , Resultado del Tratamiento , Adulto JovenRESUMEN
Estudos mostram que o tabagismo é responsável por afetar algumas funções cognitivas. No entanto, a nicotina é apenas um dos componentes existentes no cigarro e existem evidências de que pode servir como agente neuroprotetivo e causar melhoras em algumas funções cognitivas. O objetivo desta pesquisa foi investigar como a nicotina interage com algumas funções cognitivas. Um ensaio clínico piloto com administração de gomas de nicotina contendo 2-mg ou 4-mg, ou gomas placebo contendo a mesma textura, sabor e aparência, foi realizado. Quarenta e dois participantes participaram da pesquisa e os resultados indicaram que a relação entre nicotina e o desempenho na tarefa Go/No-Go podem ser bidirecionais. Os resultados indicaram que participantes do grupo que utilizaram 4-mg de nicotina apresentaram menor desempenho, enquanto os participantes que fizeram uso de 2-mg de nicotina tiveram melhor desempenho do que os demais. Esta pesquisa tem aplicações biopsicossociais e podem ajudar na compreensão da relação entre tabagismo e nicotina, além de contribuir para estratégias que possam ajudar no abandono do cigarro ou na melhora de condições que afetem a cognição (AU).
Past findings in the literature indicated that smoking could affect given cognitive functions. However, nicotine is only one of the components in cigarettes and there is evidence that it may act as a neuroprotective agent and improve some cognitive functions. The purpose of this research was to investigate how nicotine interacts with certain cognitive functions. We conducted a pilot clinical trial using nicotine gum containing 2-mg or 4-mg, or placebo gum with the same texture, flavor, and appearance. Forty-two healthy nonsmokers were enrolled in this research. Our findings indicated that the relationship between nicotine and performance on the Go/No-Go task might be opposite. The results showed that participants in the 4-mg group performed worse, while participants who used 2-mg of nicotine performed better than the others. This research supports biopsychosocial applications and can help interpret the relationship between smoking and nicotine, and contribute to strategies that may support smoking cessation, or improve conditions that affect cognition (AU).
Estudios demuestran que el tabaquismo es responsable de afectar a algunas funciones cognitivas. Sin embargo, la nicotina es solo uno de los componentes de los cigarrillos, y existen evidencias de que la nicotina puede actuar como un agente neuroprotector y mejorar algunas funciones cognitivas. El objetivo de este estudio fue investigar cómo la nicotina interactúa con algunas funciones cognitivas. Se realizó un ensayo clínico piloto con la administración de chicles de nicotina de 2 mg o 4 mg, o chicles de placebo con la misma textura, sabor y apariencia. Cuarenta y dos participantes participaron en la investigación y los resultados indicaron que la relación entre la nicotina y el rendimiento en la tarea Go/No-go puede ser bidireccional. Los resultados indicaron que los participantes del grupo de 4 mg obtuvieron un menor rendimiento en las variables del Go/No-Go, mientras que los participantes que utilizaron 2 mg de nicotina obtuvieron un mejor rendimiento que los demás. Esta investigación respalda las aplicaciones biopsicosociales y puede ayudar a interpretar la relación entre el tabaquismo y la nicotina, además de contribuir a las estrategias que pueden ayudar a dejar de fumar o mejorar las condiciones que afectan la cognición (AU).
Asunto(s)
Humanos , Masculino , Femenino , Adulto , Persona de Mediana Edad , Función Ejecutiva , Chicles de Nicotina , Nicotina/administración & dosificación , Placebos/administración & dosificación , Tabaquismo/psicología , Distribución de Chi-Cuadrado , Proyectos Piloto , Método Doble Ciego , Análisis de VarianzaRESUMEN
Abstract The present study aims to evaluate the effects of Ginkgo biloba (GKB) extract as "add- on" therapy with metformin on the lipid profile, inflammatory markers, leptin and the total antioxidant capacity (TAOC) of patients with type 2 diabetes mellitus (T2DM). It is a multi- center, randomized, placebo-controlled double-blinded clinical study. Sixty patients were allocated into two groups: control and treatment groups; they received orally either 120 mg starch/capsule or 120mg GKB/capsule, respectively as an adjuvant with metformin for 90 days. Blood samples were obtained at zero time and after 90 days. The blood was utilized for analysis of the lipid profile, inflammatory markers, leptin, and TAOC. The GKB extract produced a significant decrease in the levels of TG, LDL-c, and CRP, with a significant increase in HDL-c compared to baseline values. There were no significant changes reported in the placebo-treated group. It also produced a significant decrease in the concentrations of IL-6, TNF-α, and leptin compared to baseline values and placebo-treated groups with a significant increase in TAOC compared to baseline values. In conclusion, GKB extract, as an adjuvant with metformin, decreases inflammatory mediators, leptin level and improves the antioxidant status and lipid profile of T2DM patients improperly managed with metformin
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Humanos , Masculino , Femenino , Adulto , Persona de Mediana Edad , Pacientes , Placebos/análisis , Ensayos Clínicos Controlados Aleatorios como Asunto , Método Doble Ciego , Ginkgo biloba/efectos adversos , Diabetes Mellitus Tipo 2/complicaciones , Metformina/farmacología , Antioxidantes/administración & dosificaciónRESUMEN
ABSTRACT Objective: To evaluate the efficacy of mitomycin C in anatomical and functional success after modified transcanalicular diode laser dacryocystorhinostomy. Methods: A prospective, double-blinded, randomized placebo-controlled study compared the effect of topical mitomycin C on modified transcanalicular diode laser dacryocystorhinostomy. Group 1 had modified transcanalicular diode laser dacryocystorhinostomy with topical saline, while Group 2 had modified transcanalicular diode laser dacryocystorhinostomy with topical mitomycin C. Success was defined as anatomical patency and relief of symptoms at the end of 6 months. Results: Six months after surgery, Group 1 (30 patients) showed anatomical and functional success rates of 86.7% and 83.3%, respectively. Group 2 (32 patients) showed anatomical and functional success rates of 87.5% and 84.3%, respectively. There was no statistically significant difference between the groups 1 and 2 (p = 1.000). Conclusion: The use of mitomycin C did not improve the anatomical and functional success rates of modified transcanalicular diode laser dacryocystorhinostomy compared to placebo.
RESUMO Objetivo: Avaliar a eficácia da mitomicina C no sucesso anatômico e funcional após dacriocistorrinostomia transcanalicular com laser de diodo. Métodos: Estudo prospectivo, duplo-cego, randomizado e controlado por placebo. Comparou o efeito da mitomicina C tópica na dacriocistorrinostomia transcanalicular com laser de diodo. No Grupo 1, foi utilizada apenas solução salina tópica, enquanto no Grupo 2 foi utilizada mitomicina C tópica. O sucesso foi definido como permeabilidade da via lacrimal e alívio dos sintomas ao final de 6 meses. Resultados: Seis meses após a cirurgia, o Grupo 1 (30 pacientes) apresentou taxas de sucesso anatômico e funcional de 86,7% e 83,3%, respectivamente. O Grupo 2 (32 pacientes) apresentou taxas de sucesso anatômico e funcional de 87,5% e 84,3%, respectivamente. Não houve diferença estatística significante entre os Grupos 1 e 2 (p=1,000). Conclusão: O uso de mitomicina C não melhora as taxas de sucesso anatômico e funcional do dacriocistorrinostomia transcanalicular com laser de diodo em comparação ao placebo.
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Humanos , Masculino , Femenino , Persona de Mediana Edad , Dacriocistorrinostomía/métodos , Mitomicina/administración & dosificación , Mitomicina/uso terapéutico , Mitomicina/farmacología , Láseres de Semiconductores/uso terapéutico , Conducto Nasolagrimal/efectos de los fármacos , Placebos , Distribución Aleatoria , Método Doble Ciego , Estudios Prospectivos , Estudios de Seguimiento , Resultado del Tratamiento , Quimioterapia Adyuvante , Dacriocistitis/cirugía , Terapia por Láser/métodos , Obstrucción del Conducto Lagrimal/terapia , Conducto Nasolagrimal/cirugíaRESUMEN
Na presente mesa-redonda apresentamos a evolução do nosso aprendizado como diretor de experimentação. Relata-se o trabalho comparado de três experimentações: A primeira com alunos do 3º ano do curso de especialização em homeopatia da Associação Médica Homeopática do Paraná e as duas seguintes com pacientes da clínica homeopática do diretor de experimentação que acederam participar das mesmas. Estes pacientes funcionais, agora experimentadores em estado de equilíbrio estável, foram convidados a participar da experimentação pelo fato de terem sido bem estudados e conhecido o medicamento homeopático que reequilibrou cada um deles. Experimentou-se, pois, um medicamento pelo "duplo-cego" em experimentadores cujo medicamento era conhecido, proceder até então inédito na experimentação homeopática. Enveredou-se por esse tipo de pesquisa pelo fato de nunca antes haver sido feita a comparação entre os sintomas comuns ao medicamento do experimentador e o medicamento experimentado. Inicialmente tal proceder objetivava, além de efetuar a comparação supracitada, confirmar ou refutar a afirmação de que os sintomas que surgem durante a experimentação são comuns ao medicamento experimentado e o experimentador e não apenas exclusivos do medicamento. Com o desenrolar das experimentações outros fatos importantes foram sendo constatados, como o retorno, anos depois, de sintomas desencadeados durante a experimentação, a confirmação do perfil dos medicamentos, sintomas não registrados na descrição das patogenesias etc. Todos esses dados são discutidos à medida que é apresentada a técnica do experimento (material e método), visto que o objetivo desta mesa-redonda é discutir os encaminhamentos para novas experimentações. Nestes encaminhamentos propõe-se: algumas adições à Ficha Clínica modelo LUIMO para experimentações, discussão sobre o perfil do experimentador ideal, formação de centrais de experimentação ancoradas em diretores de experimentação, independentemente da instituição a que pertençam, visto que as instituições permanecem mas os homens por que elas passam nem sempre têm as mesmas intenções.
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Placebos , Arsenicum Album , Ensayo Patogenético Homeopático , Registros MédicosRESUMEN
Lisdexanfetamina e drogas disponíveis no SUS (metilfenidato, bupropiona, amitriptilina, clomipramina, nortriptilina). Indicação: Transtorno do Déficit de Atenção e Hiperatividade (TDAH) em crianças e adolescentes. Pergunta: Lisdexanfetamina é eficaz e segura para melhoria de sintomática, comparada ao placebo e medicações disponíveis no SUS, no tratamento de crianças e adolescentes com TDAH? Métodos: Revisão rápida de evidências (overview) de revisões sistemáticas, com levantamento bibliográfico realizado na base de dados PUBMED, utilizando estratégia estruturada de busca. A qualidade metodológica das revisões sistemáticas foi avaliada com AMSTAR-2 (A MeaSurement Tool to Assess systematic Reviews). Resultados: Foram selecionadas 3 revisões sistemáticas, que atenderam aos critérios de inclusão. Conclusão: Lisdexanfetamina e metilfenidato são mais eficazes que placebo, e similares entre si, para reduzir sintomas em escalas de avaliação. Lisdexanfetamina e metilfenidato têm risco similar ao placebo de abandono do tratamento devido a efeitos adversos. Bupropiona não é mais eficaz que placebo para alívio sintomático. Lisdexanfetamina tem efeitos adversos de redução do apetite e insônia/ dificuldades do sono. Não foram encontradas evidências na literatura sobre os efeitos terapêuticos de amitriptilina, clomipramina e nortriptilina no tratamento de crianças e adolescentes com TDAH
Lisdexamfetamine and drugs available in the Brazilian Public Health System (BPHS) (methylphenidate, bupropion, amitriptyline, clomipramine, nortriptyline, bupropion). Indication: Children and adolescents with Attention Deficit Hyperactivity Disorder (ADHD). Question: Lisdexamfetamine is effective and safe for symptomatic improvement, compared to placebo and drugs available in the BPHS, for treatment of children and adolescents with ADHD? Methods: Rapid response review of evidence (overview) of systematic reviews, with bibliographic search in the PUBMED database, using a structured strategy. The methodological quality of systematic reviews was assessed with AMSTAR-2 (A MeaSurement Tool to Assess systematic Reviews). Results: 3 systematic reviews met the inclusion criteria and were selected. Conclusion: Lisdexamfetamine and methylphenidate are more effective than placebo, and similar to each other, to reduce symptoms on rating scales. Lisdexamfetamine and methylphenidate are not different from placebo in the risk of treatment discontinuation due to adverse effects. Bupropion is no more effective than placebo for symptomatic relief. Lisdexamfetamine has adverse effects of decreased appetite and insomnia/sleep troubles. No evidence was found in the literature about therapeutic effects of amitriptyline, clomipramine and nortriptyline for treatment of children and adolescents with ADHD
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Humanos , Preescolar , Niño , Adolescente , Trastorno por Déficit de Atención con Hiperactividad/tratamiento farmacológico , Bupropión/uso terapéutico , Dimesilato de Lisdexanfetamina/uso terapéutico , Metilfenidato/uso terapéutico , Antidepresivos/uso terapéutico , Placebos , Clomipramina/uso terapéutico , Revisiones Sistemáticas como Asunto , Amitriptilina/uso terapéutico , Nortriptilina/uso terapéuticoAsunto(s)
Humanos , Masculino , Femenino , Adulto , Persona de Mediana Edad , Peso Corporal/efectos de los fármacos , Péptidos Similares al Glucagón/administración & dosificación , Péptidos Similares al Glucagón/agonistas , Sobrepeso/tratamiento farmacológico , Liraglutida/administración & dosificación , Hipoglucemiantes/administración & dosificación , Obesidad/tratamiento farmacológico , Pacientes Desistentes del Tratamiento/estadística & datos numéricos , Placebos/administración & dosificación , Estados Unidos , Esquema de Medicación , Pérdida de Peso , Ensayos Clínicos Controlados Aleatorios como Asunto , Estudios Multicéntricos como Asunto , Resultado del Tratamiento , Ensayos Clínicos Fase III como Asunto , Diabetes Mellitus , Péptidos Similares al Glucagón/efectos adversos , Sobrepeso/terapia , Liraglutida/efectos adversos , Hipoglucemiantes/efectos adversos , Inyecciones Subcutáneas , Obesidad/terapiaRESUMEN
Tecnologia: Riociguate e outros medicamentos de controle da hipertensão pulmonar. Indicação: Tratamento de Hipertensão Pulmonar Tomboembólica Crônica (HPTEC). Pergunta: Há superioridade em eficácia e segurança do riociguate, comparado a medicamentos disponíveis no SUS, no tratamento de HPTEC inoperável ou operada com hipertensão pulmonar residual? Métodos: Revisão rápida de evidências (overview) de revisões sistemáticas, com levantamento bibliográfico realizado na base de dados PUBMED, utilizando estratégia estruturada de busca. A qualidade metodológica das revisões sistemáticas foi avaliada com AMSTAR-2 (Assessing the Methodological Quality of Systematic Reviews). Resultados: Foram selecionadas 4 e incluídas 2 revisões sistemáticas. Conclusão: Comparado ao placebo, em tratamento de curto prazo de HPTEC, riociguate melhora a tolerância ao exercício, aumenta a chance de melhora da classificação funcional e tem similar risco de eventos adversos sérios, porém não reduz a mortalidade. Treprostinil tem efeitos similares a riociguate. Entretanto, ambrisentana, bosentana, macitentana ou sildenafila não diferem do placebo no tratamento de HPTEC
Technology: Riociguat and other drugs to control pulmonary hypertension. Indication: Treatment of chronic thromboembolic pulmonary hypertension (CTEPH). Question: Is riociguat more effective and safe than other drugs available in the Brazilian Public Health System for the treatment of inoperable or recurrent CTEPH? Methods: Rapid review of evidence (overview) from systematic reviews, with a bibliographic search in the PUBMED database, using a structured strategy. The methodological quality of systematic reviews was assessed with AMSTAR-2 (Methodological Quality Assessment of Systematic Reviews). Results: Four systematic reviews were selected and two included in this study. Conclusion: Compared to placebo, in the short-term treatment of CTEPH, riociguat improves exercise tolerance, increases the chance of improving functional classification, and has a similar risk of serious adverse events, but does not reduce mortality. Treprostinil has similar effects to riociguat. However, ambrisentan, bosentan, macitentan or sildenafil do not differ from placebo in the treatment of CTEPH