Beneficios de la terapia con hidroxiúrea en niños con anemia de células falciformes = Benefits of hidroxyurea therapy in children with sickle cell disease

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Donado Gómez, Jorge Hernando

2012-04-01

Full Text Available Objetivo: describir la toxicidad y los beneficios de la hidroxiúrea (HU en el tratamiento de niños con anemia de células falciformes (ACF.Materiales y métodos: estudio observacional descriptivo-retrospectivo de pacientes con ACF tratados con HU en el Hospital Pablo Tobón Uribe (HPTU de Medellín, Colombia, entre mayo de 2004 y septiembre de 2009. Se trató con este medicamento a 16 pacientes menores de 15 años, 11 de ellos (68,8% de sexo masculino. Todos los pacientes tenían anemia falciforme (Hb SS. Las variables se estudiaron antes y después del inicio de la HU. Resultados: se encontró una media de crisis dolorosas por ACF de 3,31 antes y 1,13 después de la HU (p = 0,006; la media de la necesidad de transfundir glóbulos rojos fue de 2,69 antes y 0,75 después (p = 0,112; los episodios de síndrome torácico agudo (STA tuvieron una media de 0,19 antes y 0,13 después (p = 0,705; la media de la necesidad de hospitalización por ACF fue de 1,94 antes y 1,06 después de la HU (p = 0,155. Un paciente (6,3% presentó toxicidad hematológica y dos (12,5% tuvieron toxicidad hepática, pero no hubo casos de toxicidad renal; tres pacientes (18,8% presentaron accidentes cerebrovasculares. No se encontraron neoplasias. Conclusión: la HU redujo significativamente la frecuencia de crisis dolorosas en los pacientes con ACF. La toxicidad fue en general aceptable. Se requieren estudios prospectivos, multicéntricos, doble ciego, controlados con placebo, para definir el papel de la HU en pacientes pediátricos.

Generación de experiencias visuales en ciegos mediante estimulación táctil repetitiva

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Tomás Ortiz

2012-02-01

Full Text Available Estudios recientes de nuestro laboratorio han establecido que se puede generar una activación estable del córtex visual en ciegos mediante entrenamiento táctil pasivo prolongado. Esta neuroplasticidad cortical se acompaña en un 40% de los participantes invidentes de sensaciones visuales, así como de una mayor rapidez en el reconocimiento táctil de información espacial tales como líneas, iconos o imágenes, y es crucial para su correcta interpretación. Estos hallazgos pueden ser útiles para el diseño de mecanismos sustitutivosde la visión en ciegos, pero también son útiles para entender ciertos síntomas neuropsiquiátricos como lassinestesias.

Selección de emplazamientos para vertederos controlados

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del Pozo Manrique, Marcos

1991-04-01

Full Text Available The objective of this article is to bring forward some ideas about the method for the correct election of sanitary landfill sites. Three subjects are developed: — Solid wasting problem and their technical solutions. — Territorial qualification for sanitary landfiliing. — Application to a particularly territory: the Alcalá de Henares area, in the Madrid province. The ground is the principal agent is sanitary landfiliing, so the correct design of sites is essential to obtain high levels of environmental safety.

El objetivo del presente trabajo es aportar algunas ideas sobre la estrategia básica para la correcta ubicación de vertederos controlados. Para ello se abordan tres temas: — Problemática de los residuos sólidos urbanos y soluciones técnicas aportadas por el vertido controlado, indicando su campo de aplicación así como las principales Interacciones con el medio de este tipo de instalación. — A la vista de esta información previa, definición de los principales requisitos exigibles a nuestro juicio al territorio para la ubicación de un vertedero, así como los criterios para su valoración y selección. — Por último, aplicación a la selección de emplazamientos para el vertido controlado en un territorio concreto, en este caso la comarca de Alcalá de Henares, en la provincia de Madrid. Debido a que el vertido controlado es un medio de eliminación en el que el principal agente técnico es el mismo terreno donde se asiente la instalación, pensamos que una correcta ubicación es la principal garantía para obtener unos niveles duraderos de seguridad ambiental y un comportamiento adecuado en las vertientes económica y social.

Corporativismo en el área del bienestar. El caso de la Organización Nacional de Ciegos

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ROBERTO GARVÍA SOTO

1994-01-01

Full Text Available La literatura sobre corporativismo ha señalado la escasa probabilidad de que surjan acuerdos de tipo corporativista en el ámbito del bienestar. Esta literatura ha anticipado que, en caso de emerger un acuerdo de este tipo en el ámbito del bienestar, este acuerdo será promovido por organizaciones profesionales que operan en este ámbito. En contra de esta predicción, este artículo analiza un caso desviado, que hace referencia a la organización de ciegos españoles (once, que monopoliza la representacióin de intereses de los ciegos y la provisión de servicios de bienestar a los mismos. El artículo examina brevemente la naturaleza del acuerdo corporativista que tiene lugar entre el estado y la once, y explica como este acuerdo, limitado originariamente al caso de los ciegos, se ha expandido sobre el conjunto del área de las minusvalias, de tal modo que la once ha conseguido no sólo controlar y gobernar el sistema de represenación de intereses de otros grupos de minusvalidos, sino también asumir políticas públicas que afectan a estos otros colectivos.

El lenguaje de los niños ciegos y la cuestión de los rasgos autistas

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Miguel Pérez Pereira

2000-12-01

Full Text Available Hobson et al. (Brown, Hobson. Lee y Stevenson, 1997; Hobson, Brown, Minter y Lee, 1997 han investigado la similitud entre el autismo y la ceguera congénita. En este artículo se revisa la evidencia empírica a favor de la existencia de rasgos autistas en el lenguaje de los niños ciegos de nacimiento, a la vez que se aportan nuevos datos de investigaciones del autor. Se centra el interés en (a el uso de los pronombres personales, (b el uso de imitaciones y habla formuláica, (c el uso egocéntrico del lenguaje, y (d la capacidad de iniciar conversaciones y de contingencia conversacional. El análisis pone en cuestión la supuesta similitud entre los niños ciegos y los autistas, además parece refutar la teoría de Hobson.

Simulaci??n y modelado de transistores MOS de doble puerta

OpenAIRE

Cartujo Cassinello, Pedro

2000-01-01

En este trabajo se hace un estudio del transistor MOS de doble puerta analizando las posibles ventajas de esta nueva estructura frene al transistor convencional y el transistor MOS SOI de puerta simple. Para ello se ha analizado una secci??n transversal de un transistor MOS de doble puerta de canal N, con el fin de examinar detalladamente las peculiaridades de la distribuci??n de electrones con una amplia variedad de valores de todos los par??mentros tecnol??gicos y condiciones de operaci??n,...

Caracterización socioeconómica y tecnológica de la producción ovina en Ciego de Ávila, región Central de Cuba (Parte I Socioeconomic and technological characterization of sheep production in Ciego de Ávila, central region of Cuba (Part I

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Ángela Borroto¹

2011-06-01

Full Text Available Con el objetivo de caracterizar los sistemas de producción ovina en Ciego de Ávila desde el punto de vista socioeconómico y tecnológico, se encuestaron 6, 13 y 11 fincas de productores privados asociados a cooperativas de créditos y servicios (CCS en los municipios de Baraguá, Ciego de Ávila y Ciro Redondo, respectivamente. Se logró identificar los factores socioeconómicos y tecnológicos que limitaban el incremento de sus producciones, así como las tipologías de los sistemas existentes, los aspectos socioeconómicos, la infraestructura, las capacidades tecnológicas y las características del potencial humano vinculado a su producción animal. Los resultados indicaron que la producción ovina se desarrolló como una alternativa para sustentar el autoconsumo cárnico y la economía familiar, con predominio de la raza Criolla Pelibuey comercial. La situación higiénica de esas crianzas fue aceptable, en las que predominó el sistema de manejo extensivo, con pastoreo continuo sobre pastos naturales de baja calidad y rebaños integrales de 20-40 ovinos para Baraguá y Ciro Redondo, y de hasta 20 ovinos en Ciego de Ávila. Las ventas por convenios a la Empresa de Ganado Menor resultaron inferiores a las esperadas, con un peso vivo medio próximo a los 30 kg, y se demostró que los productores encuestados recibieron poca atención por asociaciones e instituciones aptas para capacitar y/o brindar asistencia técnica.In order to characterize sheep production systems in Ciego de Ávila from the socioeconomic and technological point of view, 6, 13 and 11 farms of private farmers associated to credit and services cooperatives (CCS were surveyed in the Baraguá, Ciego de Ávila and Ciro Redondo municipalities, respectively. The socioeconomic and technological factors that limited the increase of their productions were identified, as well as the typologies of the existing systems, the socioeconomic aspects, the infrastructure, technological

Brotes de leptospirosis humana en la provincia de Ciego de Ávila, Cuba Human leptospirosis outbreak in the district of Ciego de Ávila, Cuba

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Miguel Suárez Hernández

1999-02-01

Full Text Available Se analizan los brotes de leptospirosis ocurridos en la provincia de Ciego de Ávila en el periodo de 1980 a 1995. En la etapa se notifican 40 brotes. Las actividades principales vinculadas a los mismos fueron la atención al cultivo de la caña de azúcar, al cultivo del plátano, el baño en río y las inundaciones. Se nota un incremento de brotes a partir del mes de junio. En los meses de octubre y noviembre se reportan las mayores incidencias. Los grupos de edades que más casos aportaron fueron de 10-14 años, 15-19 años y 30-34 años. El sexo más afectado fue el masculino. Los grupos más afectados fueron los estudiantes, pobladores urbanos y trabajadores agrícolas cañeros. De los 40 brotes, 21 fueron confirmados por medio de la prueba de microaglutinación y 19 por la prueba hemolitica, siendo los serogrupos más frecuentes Pomona y Australis.Forty leptospirosis outbreaks occurred in Ciego de Avila province from 1980 to 1995. The main events involved in the outbreaks were floods, bathing in rivers and activities related to sugar cane and banana cultivation. The number of cases increased after June, with higher incidences reported in October and November. The most affected age groups were 10-14 years, 15-19 years and 30-34 years. Men were more affected than women. Students, people residing in the urban zone and farmers were the most affected groups. A total of 21 outbreaks out of 40 were confirmed by the microagglutination test and the remaining 19 by the hemolytic test. Pomona and Australis were the serogroups most frequently detected by microagglutination.

Simulación y modelado de transistores MOS de doble puerta

OpenAIRE

Cartujo Cassinello, Pedro

2013-01-01

En este trabajo se hace un estudio del transistor MOS de doble puerta analizando las posibles ventajas de esta nueva estructura frene al transistor convencional y el transistor MOS SOI de puerta simple. Para ello se ha analizado una sección transversal de un transistor MOS de doble puerta de canal N, con el fin de examinar detalladamente las peculiaridades de la distribución de electrones con una amplia variedad de valores de todos los parámentros tecnológicos y condiciones de operación, y se...

Tras la huella del desconocido maestro ciego del Colegio de Sordomudos y Ciegos de Santiago: Juan Lorenzo González (finales del siglo XIX

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Rodríguez Díaz, Ana

2015-12-01

Full Text Available Dissemination of Braille as an alternative means of visual communication has been a key factor in the integration of blind people. The Braille system was introduced in Argentina by teaching Juan Lorenzo González.This article aims to contribute to the knowledge of the unknown blind master. Although he remained in Spain overshadowed by other teachers, his altruistic personality led him to settle in the city of Buenos Aires, where he developed his greatest educational work. On 1 March 1887, the official of the Sociedad de Beneficencia of Buenos Aires proposed to him, a newcomer to this city, as a teacher of the blind people in the Asilo de Huérfanos. The proposal was accepted with a quick response and a few months after his appointment, he began his task. It was then when the institutional and professional care of the blind people in Argentina began; until then had only the blind received material support and charitable shelter. This study was approached from a historical perspective, has been based on archival sources,historical and current newspapers and publications, mainly Argentina. In this research reveal meaningful data that allow some of the unknowns about the biography of this remarkable personality.La difusión del sistema Braille como un medio de comunicación alternativo al visual ha supuesto un factor determinante en la integración de las personas ciegas. El sistema Braille se introdujo en Argentina mediante la enseñanza de Juan Lorenzo González. Este artículo pretende contribuir al conocimiento de este ignorado maestro ciego. A pesar de que en España permaneció eclipsado por otros pedagogos, su personalidad altruista le llevó a instalarse en la ciudad de Buenos Aires, donde desarrolló su mayor obra pedagógica. El 1 de marzo de 1887, recién llegado a dicha ciudad, la dirigente de la Sociedad de Beneficencia de Buenos Aires propuso al pedagogo español como profesor de ciegos en el Asilo de Huérfanos. La propuesta se acept

Reactogenicity of yellow fever vaccines in a randomized, placebo-controlled trial Reatogenicidade de vacinas contra febre amarela em estudo randomizado, controlado com placebo

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Luiz Antonio Bastos Camacho

2005-06-01

Full Text Available OBJECTIVE: To compare the reactogenicity of three yellow fever (YF vaccines from WHO-17D and Brazilian 17DD substrains (different seed-lots and placebo. METHODS: The study involved 1,087 adults eligible for YF vaccine in Rio de Janeiro, Brazil. Vaccines produced by Bio-Manguinhos, Fiocruz (Rio de Janeiro, Brazil were administered ("day 0" following standardized procedures adapted to allow blinding and blocked randomization of participants to coded vaccine types. Adverse events after immunization were ascertained in an interview and in diary forms filled in by each participant. Liver enzymes were measured on days 0, 4-20 and 30 of the study. Viremia levels were measured on days 4 to 20 of follow-up. The immune response was verified through serologic tests. RESULTS: Participants were mostly young males. The seroconversion rate was above 98% among those seronegative before immunization. Compared to placebo, the excess risk of any local adverse events ranged from 0.9% to 2.5%, whereas for any systemic adverse events it ranged from 3.5% to 7.4% across vaccine groups. The excess risk of events leading to search for medical care or to interruption of work activities ranged from 2% to 4.5%. Viremia was detected in 3%-6% of vaccinees up to 10 days after vaccination. Variations in liver enzyme levels after vaccination were similar in placebo and vaccine recipients. CONCLUSIONS: The frequency of adverse events post-immunization against YF, accounting for the background occurrence of nonspecific signs and symptoms, was shown for the first time to be similar for vaccines from 17D and 17DD substrains. The data also provided evidence against viscerotropism of vaccine virus.OBJETIVO: Comparar a reatogenicidade de três vacinas contra a febre amarela (FA das sub-cepas WHO-17D e 17DD (diferentes lotes-semente, e placebo. MÉTODOS: Foram recrutados 1.087 adultos elegíveis para vacinação contra FA no Rio de Janeiro, RJ, Brasil. Vacinas produzidas por Bio

Clonixinato de lisina oral para o tratamento agudo da migrânea: estudo duplo-cego e placebo-controlado

OpenAIRE

Krymchantowski, Abouch V.; Barbosa, Jackeline S.; Cheim, Celia; Alves, Luiz A.

2001-01-01

Several oral nonsteroidal anti-inflammatory drugs (NSAIDs) are effective to treat migraine attacks. Lysine clonixinate (LC) is a NSAID derived from nicotinic acid that has proven to be effective in various pain syndromes such as renal colic and muscular pain. The aim of this double-blind, placebo-controlled study was to evaluate the efficacy of oral LC compared to placebo in the acute treatment of migraine. Sixty four patients with the diagnosis of migraine, according to the IHS criteria, wer...

Rappresentazioni e (intraducibilità del delirio: Informe sobre ciegos di Alberto Breccia

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Susanna Nanni

2015-07-01

Full Text Available The essay proposes an analysis of the relationship between text and images in Informe sobre ciegos (1991 by Alberto Breccia. In his obstinate renunciation to unnecessary words, or surplus signs, and by employing graphic devices that convey a "telluric and formless" world, Breccia interprets and illustrates – without making it comprehensible – the self-destructive delirious state of Fernando Vidal, one of the most controversial and fascinating characters in Argentinian literature. In particular, the essay focuses on the conspiracy – at the level of both form and content – and on the graphic (untranslatability of his delirium.

Preso y drogodependiente: doble estigma

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Rafael Clua García

2010-12-01

Full Text Available Fornons Fontdevila, David (2009. Prisión y drogas: doble condena. Barcelona: deParís. David Fornons Fontdevila, tras varios años de trabajo en diferentes ámbitos del Centro Penitenciario de Hombres de Barcelona, La Modelo, ha realizado esta etnografía sobre las personas drogodependientes privadas de libertad. Ha conseguido desnudar su situación, abriéndonos las puertas de una institución de la que poco se habla y mucho menos cuando se asocia a los consumidores de drogas.

Doble Vínculo: "Tejer de la Arquitectura y el Arte; en el entorno del Arte Conceptual"

OpenAIRE

Muñoz Pardo, María Jesús

2008-01-01

Desde los comienzos de mi actividad investigadora he estado interesada en la bipolaridad comunicativa _Doble vínculo entre la Arquitectura y el Arte, así como en un pensamiento dialógico en el que teoría y práctica sean indisociables. ¿Qué acciones pueden forzar las coordenadas de un Pensamiento Crítico de la Arquitectura (en estos momentos)? Dice B. Russell: >. Esta frase que he elegido para iniciar mi presentación hace referencia a la doble condición del pensamiento, a ese doble v...

Conducta de búfalos en pastoreo en humedales de Ciego de Ávila, Cuba Behavior of grazing buffaloes in wetlands of Ciego de Ávila, Cuba

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A Caraballoso¹

2011-06-01

Full Text Available Con el objetivo de caracterizar la conducta de búfalos en pastoreo en el humedal avileño se realizó el presente estudio en áreas de la Empresa Agropecuaria del municipio Bolivia, en el Humedal Norte de la provincia Ciego de Ávila, Cuba. Se emplearon búfalos de río, de pantano y bufalipso mestizo, clínicamente sanos. Para determinar la composición florística se hicieron diferentes transeptos por el procedimiento de la línea intercepto. Se evaluó el comportamiento bufalino en pastoreo durante 10 días consecutivos y en ambas épocas del año, a través del método visual adaptado para esta especie. Se identificaron en el área de pastoreo de los búfalos un total de 165 especies vegetales correspondientes a 20 familias. Los animales dedicaron la mayor parte del tiempo al pastoreo en ambos períodos (58,5 y 64,3% para los períodos I y II, respectivamente, seguido de la rumia (13,2 y 15,1%, respectivamente. Se concluye que el estudio de la conducta resulta una herramienta importante en la explotación y manejo del búfalo; se apreció que los búfalos dedicaron el mayor porcentaje del tiempo a la actividad de pastoreo, con tendencia a su incremento en las tres primeras horas del día. Se recomienda intensificar la siembra de la cobertura vegetal para evitar su deterioro, así como la migración de los animales a otros ecosistemas.With the objective of characterizing the behavior of grazing buffaloes in a Ciego de Ávila wetland, this study was conducted in areas of the Livestock Production Enterprise of the Bolivia municipality, in the Northern Wetland of the Ciego de Ávila province. Clinically healthy river, swamp and crossbred Buffalypso buffaloes were used. In order to determine the floristic composition different transepts were made through the intercept line procedure. The behavior of the grazing buffaloes was evaluated for 10 consecutive days and in both seasons, through the visual method adapted for this species. A total of 165

Niveles de dolor y tolerancia a la biopsia endometrial, con ibuprofeno

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Juan Carlos Palomino Baldeon

2003-07-01

Full Text Available Objetivo: Comparar los niveles de dolor y tolerancia a la biopsia endometrial con la cureta de Novak (Rígida, en pacientes que reciben Ibuprofeno 800mg vs placebo, 30 a 45 min. antes del procedimiento. Material y Métodos: Se realizó un estudio ensayo clínico, doble ciego, randomizado y comparativo. Se incluyerón 25 pacientes por grupo de tratamiento quienes recibieron dos cápsulas de Ibuprofeno de 400mg vo o dos cápsulas de placebo vo según corresponda. Se comparó entre ambos grupos, datos de filiación, antecedentes gineco-obstétricos, motivo de la biopsia de endometrio y finalmente valoración de su experiencia de dolor y tolerancia al procedimiento. Resultados: En poblaciones comparables al evaluar la variable dolor se encuentra que existe diferencia estadísticamente significativa entre los valores de dolor del grupo que recibió Ibuprofeno (Mediana 45mm contra el grupo que recibió placebo (Mediana 65mm con un p=0.0137. No se encuentra diferencia en cuento a la valoración de la tolerancia entre el grupo que recibió Ibuprofeno (Mediana 37mm contra el grupo que recibió placebo (53mm con un p=0.23. Conclusión: Se concluye que la utilización de 800mg de Ibuprofeno vía oral 30 a 45 minutos antes de la biopsia endometrial en pacientes mayores de 44 años disminuye su experiencia de dolor durante el procedimiento. (Rev Med Hered 2003; 14: 122-127.

Eficacia de dos métodos de intervención en fisioterapia aplicados en sujetos del ámbito socio-sanitario con dolor cervical inespecífico

OpenAIRE

Cardero Durán, María de los Ángeles

2016-01-01

Estudio experimental prospectivo, controlado y simple ciego en trabajadores del ámbito socio sanitario diagnosticados de dolor cervical inespecífico. El objetivo fue valorar la eficacia de dos tratamientos de fisioterapia (masoterapia y TENS / masoterapia y ejercicios de estiramientos) sobre las variables: grado de discapacidad, dolor percibido (Escala Visual Analógica y algometría), rango de movilidad articular y estado de salud así como determinar si existen diferencias en cuanto a los resu...

Galaxias australes con núcleo doble

Science.gov (United States)

Gimeno, G.; Díaz, R.; Carranza, G.

Se estudia una muestra de galaxias australes con núcleo doble a partir de una búsqueda extensiva en la literatura. Se analizan las características morfológicas, fotométricas y espectroscópicas de la muestra. Para algunas galaxias se han realizado observaciones con el espectrógrafo multifunción (EMF) de la Estación Astrofísica de Bosque Alegre a partir de las cuales se determinaron parámetros cinemáticos.

Effect of Lactobacillus strains and Saccharomyces boulardii on persistent diarrhea in children

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D. Gaon

2003-08-01

Full Text Available The efficacy of probiotics on persistent diarrhea remains uncertain. The purpose of this study was to evaluate the effect of Lactobacillus sp and Saccharomyces boulardii on persistent diarrhea in children. In a double-blind trial eighty-nine children, aged 6-24 months were randomly distributed to receive pasteurized cow milk containing 2 viable lyophilized strains Lactobacillus casei and Lactobacillus acidophillus strains CERELA, (1010-1012 colony-forming units per g (n =30, or lyophilized S. boulardii, (1010-1012 colony forming units per g (n =30 or pasteurized cow milk as placebo (n =29; on each diet 175 g was given twice a day for a 5 day period. Number of depositions, duration of illness and frequency of vomiting were considered. Enteric pathogens were isolated from stools in 40% of the patients, 27% had rotavirus. Lactobacillus and S.boulardii significantly reduced the number of depositions (p La eficacia de los probióticos sobre la diarrea persistente en niños aún no ha sido comprobada. Este trabajo controlado doble ciego tuvo como propósito evaluar ese efecto usando Lactobacillus sp y Saccharomyces boulardii. Ochenta y nueve niños entre 6 meses y 2 años de edad fueron distribuidos al azar para recibir leche pasteurizada conteniendo cepas liofilizadas de Lactobacillus casei y Lactobacillus acidophillus desarrolladas por CERELA (Centro de Referencia para Lactobacilos (1010-1012 CFU por g, n=30, o cepas liofilizadas de S. boulardii (1010-1012 CFU por g, n = 30, o placebo, n =29. Cada niño recibió 175 g dos veces por día durante 5 días. Se evaluó el número de deposiciones/día, la duración de la diarrea y la duración de los síntomas. Se aislaron gérmenes patógenos en las heces en el 40% de los casos: 27% eran rotavirus. Lactobacillus sp y S. boulardii redujeron significativamente el número de deposiciones (p < 0.001, la duración de la diarrea y el número de vómitos (p< 0.005 y (p< 0.002 respectivamente, comparado con

Eficácia a curto prazo do laser de baixa intensidade em pacientes com osteoartrite do joelho: ensaio clínico aleatório, placebo-controlado e duplo-cego Short-term efficacy of low-level laser therapy in patients with knee osteoarthritis: a randomized placebo-controlled, double-blind clinical trial

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Vanessa Ovanessian Fukuda

2011-10-01

Full Text Available OBJETIVO: Este estudo foi designado para avaliar a eficácia a curto prazo da laserterapia de baixa intensidade (LBI na melhora da dor e função em pacientes portadores de osteoartrite (OA do joelho. MÉTODOS: Participaram deste ensaio clínico aleatório, duplo-cego e controlado 47 pacientes (79 joelhos de ambos os sexos portadores de OA do joelho, que foram distribuídos aleatoriamente em dois grupos; grupo laser com 25 pacientes (41 joelhos e grupo placebo com 22 pacientes (38 joelhos. A LBI foi realizada três vezes por semana totalizando nove sessões, com uso do laser AsGa de 904nm, 60mW de potência média e 0,5cm² de área do feixe, sendo irradiados nove pontos no joelho com energia de 3,0J por ponto. O grupo placebo foi tratado com o mesmo aparelho de laser, porém com uma caneta selada. As avaliações Lequesne, escala visual numérica (EVN, Timed Up and Go (TUG, goniometria e dinamometria foram realizadas antes do início do tratamento e após as nove sessões da LBI. RESULTADOS: Foi encontrada melhora significante da dor e função para todas as avaliações aplicadas no grupo laser. Quando comparado o grupo laser ao grupo placebo encontrou-se diferença significante para as avaliações EVN-Repouso e Lequesne. CONCLUSÃO: O tratamento com a LBI melhora a dor e função a curto prazo de pacientes portadores de OA do joelho.OBJECTIVE: This study was designed to evaluate the short-term efficacy of low-level laser therapy (LLLT for improving pain and function in patients with knee osteoarthritis. METHODS: Forty-seven patients with knee osteoarthritis (79 knees, of both genders, participated in this randomized controlled double-blind clinical trial. They were randomly allocated to two groups: laser group with 25 patients (41 knees and placebo group with 22 patients (38 knees. LLLT was performed three times a week, totaling nine sessions, using a AsGa 904 nm laser with mean power of 60 mW and beam area of 0.5 cm². Nine points were

Inventory of land snails from Boquerones, Ciego de Avila, Cuba

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Félix Jonathan Pereira-Miller

2015-10-01

Full Text Available A census of mollusks in Boquerones, Ciego de Avila, Cuba was carried out. Biodiversity index were studied by vegetal formation, which are: Evergreen Forest, Semideciduous Forest and Mogote Vegetation Complex. The families best represented were Helicinidae, Annularidae, Urocoptidae and Subulinidae, taking the 97.6% of the species some degree of national endemism and being the 45.24% of these local endemic. The most widely distributed species was Farcimen camaguayanum Torre & Bartsch 1941 and the rarest was Euclastaria euclasta Shuttleworth 1852. The highest biodiversity values were observed in the Mogote Vegetation Complex being of 2,856 according to Shannon-Wiener (H´ index. So far species extinction events are not seen but not discarded for the future due to a decline in local rainfall during the last 15 years as well as human activities such as agriculture and local tourism.

Ensayo clínico doble ciego, controlado para evaluar la efectividad analgésica de 100 microgramos de morfina intratecal en el control del dolor postoperatorio

OpenAIRE

Herrera Gómez, Pedro; García Ulloa, Adriana; Eslava Schmalbach, Javier

2006-01-01

Antecedentes:La morfina intratecal constituye una excelente alternativa para el manejo del dolor post-operatorio, en cirugías con anestesia espinal. La efectividad analgésica post-operatoria de 100 µg de morfina, adicionados al anestésico local en anestesia espinal, ha sido estudiada en cirugías de cesárea, resección transuretral de próstata y reemplazos articulares. El propósito de este estudio es valorar la efectividad analgésica de 100 µg de morfina intratecal en adultos jóvenes, sometidos...

Species of beetles (Coleoptera; Scarabaeidae associated to banana (Musa spp. in Ceballos, Ciego de Avila, Cuba

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Maria Luisa Sisne Luis

2016-03-01

Full Text Available A white light trap was placed in bananas plantations, according to Sisne, 2009 and MINAG, 1985, in the Citric enterprise of Ciego de Ávila during the period between May and July of 2010 with the objective of determining the composition of genus and species of the order Coleoptera family Scarabaeidae associated to the agroecosystem. The species Cyclocephala cubana Chapin, Phyllophaga puberula Duval, and Phyllophaga patruelis Chev. are associated to bananas crops in these areas.

Scarabaeidae species associate to guava ( Psidium guajava L. in Ciego de Ávila, Cuba

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Maria Luisa Sisne Luis

2013-01-01

Full Text Available Se colocó una trampa de luz blanca en las plantaciones de la Guayaba (Psidium guajava L., según establece Sisne, 2009 y MINAG, 1985, en la Empresa Cítricos de Ciego de Ávila durante el período comprendido entre mayo y julio del año 2010 con el objetivo de determinar la composición de géneros y especies del orden Coleoptera familia Scarabaeidae asociadas al agroecosistema. Se determinó que las especies Cyclocephala cubana Chapin, Phyllophaga puberula Duval, y Phyllophaga patruelis Chev. están asociadas al cultivo de la Guayaba en estas áreas.

Generación de experiencias visuales en ciegos mediante estimulación táctil repetitiva

OpenAIRE

Tomás Ortiz; Juan M. Santos

2012-01-01

Estudios recientes de nuestro laboratorio han establecido que se puede generar una activación estable del córtex visual en ciegos mediante entrenamiento táctil pasivo prolongado. Esta neuroplasticidad cortical se acompaña en un 40% de los participantes invidentes de sensaciones visuales, así como de una mayor rapidez en el reconocimiento táctil de información espacial tales como líneas, iconos o imágenes, y es crucial para su correcta interpretación. Estos hallazgos pueden ser útiles para el ...

Ejercicios acuáticos y calidad de vida en pacientes con osteoartritis de cadera: propuesta de intervención.

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Coello Montesinos, Nayra

2015-01-01

Hipótesis / pregunta clínica de investigación: los ejercicios físicos en el medio acuático pueden ser eficaces para mejorar la calidad de vida en pacientes con osteoartritis de cadera. Objetivo: determinar la efectividad de los ejercicios acuáticos en pacientes con osteoartritis de cadera complementado a un tratamiento de fisioterapia convencional. Metodología: Se llevará a cabo un ensayo clínico controlado aleatorio y de ciego único en la ciudad de Lleida con 91 participantes voluntarios pro...

Eficacia de la Terapia Psicoeducativa Motivacional Breve Dual (TPMB-D) en pacientes hospitalizados con trastorno por uso de sustancias y patología dual

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Benito Delegido, Ana María

2015-01-01

El Hospital Provincial de Castellón adaptó la Terapia Psicoeducativa Motivacional Breve (efectiva en pacientes con trastorno por uso de sustancias (TUS) en Unidad de Desintoxicación Hospitalaria) para pacientes con patología dual (PD)(TPMB-D). Este estudio experimental doble ciego usó dos grupos aleatorios para evaluar la eficacia de la TPMB-D comparada con terapia ocupacional (TO) en pacientes hospitalizados con TUS y con PD. Completaron el estudio 163 pacientes, de los que el 68.7% prese...

Nanocomposites transparentes multifuncionales de hidróxido doble laminares

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Fernández Vilaber, Antonio

2017-01-01

Este trabajo trata sobre obtener una serie de materiales nanocompuestos en forma de película para usarlos como plásticos de invernadero. Para ello se sintetizarán hidróxidos dobles laminares modificados con un agente blanqueante óptico que mejorará las propiedades ópticas del material Escuela Técnica Superior de Ingeniería Industrial Universidad Politécnica de Cartagena

La Preparación de las auxiliares pedagógicas para la enseñanza de la educación doméstica en escolares ciegos

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Liliam Almaguer Fernández

2010-01-01

Full Text Available Se plantea que La educación cubana dirige todos sus esfuerzos a favor de la atención educativa de los escolares, en particular aquellos con Necesidades Educativas Especiales Sensoriales visuales. Tales propósitos solo se harán realidad si las auxiliares pedagógicas son las encargadas de la continuación del proceso docente educativo en los escolares ciegos con la preparación requerida. A partir de las insuficiencias generales y particulares de las auxiliares pedagógicas dirigidas hacia la educación doméstica se diseñan Talleres Metodológicos relacionados con los contenidos teóricos en los que se sustenta esta temática lo cual favorece la preparación del escolar ciego para su vida adulta e independiente.

Caracterización de precipitaciones diarias en el municipio de Ciego de Ávila, Cuba

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Brown Manrique, Oscar; Díaz Ruiz, Reinier; Gallardo Ballat, Yurisbel; Valero Freyre, Jorge

2017-01-01

La investigación analizó una serie de 30 años de precipitaciones diarias del municipio Ciego de Ávila en el periodo 1983-2012. Se consideraron 43 800 datos correspondientes a los pluviómetros CA-87; CA-102; CA-722 y CA-894. Los resultados demostraron que la pluviometría anual es de 1243,5 mm y los mayores valores se presentan en junio y septiembre con 228,9 mm y 221,3 mm respectivamente. El tipo de lluvia predominante es la inferior a 50 mm en 24 horas las cuales suceden en 86 días en el año....

Radiation Risk to Patients from Nuclear Medicine Procedures in Camaguey and Ciego de Avila Provinces (Cuba) during the period 2000-2005

International Nuclear Information System (INIS)

Brigido Flores, O.; Barreras Caballero, A.

2015-01-01

Population radiation dose estimation due to administration of radiopharmaceuticals in Camaguey and Ciego de Avila provinces was carried out using Medical Internal Radiation Dose scheme (MIRD). Data were gathered on the type of radiopharmaceuticals used, the administered activity, the numbers of each kind of examination, and the age and sex of the patients involved during the period 2000 - 2005. The average annual frequency of examinations was estimated to be 3.65 per 1000 population. The results show that imaging nuclear medicine techniques of thyroid and bone explorations with 13.3 and 12.9%, respectively and iodide uptake with 50% are the main techniques implicated in the relative contribution to the total annual effective collective dose which averaged 95 man-Sv for the studied period. Radiation risks for the Camaguey-Ciego de Avila population caused by nuclear medicine examinations in the period studied were calculated: the total number of fatal and non-fatal cancers was 34.2 and the number of serious hereditary disturbance was 7.4 as a result of 24139 nuclear medicine procedures, corresponding to a total detriment of 1.72 per 1000 examination. (Author)

Caudal ecológico del río Chambas en la provincia Ciego de Ávila

OpenAIRE

Brown Manrique, Oscar; Gallardo Ballat, Yurisbel; Williams Harriote, Patricio W.; Torres Martínez, Yuneisi

2016-01-01

La investigación se desarrolló en el río Chambas de la provincia Ciego de Ávila con el objetivo de determinar el caudal ecológico mediante cinco metodologías: Curva de Permanencia de Caudales, Rafael Heras, Tennant, Franquet y Perímetro Mojado. Se analizó una serie de 21 años de gastos medios mensuales en el periodo comprendido de 1976 al 1986, obtenidos de la estación hidrométrica Puente Circuito Norte. Los principales resultados demostraron que los caudales promedios del río Chambas present...

Coadjuvant hypoglycemiant effect of Annona muricata L (guanabana) leaves ethanolic extract in patients with type 2 diabetes mellitus receiving glibenclamide treatment

OpenAIRE

Arroyo, Jorge; Martínez, Jaime; Ronceros, Gerardo; Palomino, Robert; Villarreal, Aníbal; Bonilla, Pablo; Palomino, Christian; Quino, Mariano

2012-01-01

Objetivo: Determinar la eficacia y seguridad de cápsulas de extracto etanólico de hojas de Annona muricata L (guanábana) más glibenclamida para un mejor control de los niveles glicemia comparado con la administración de glibenclamida sola, en pacientes con diabetes mellitus tipo 2. Diseño: Estudio clínico, aleatorio, grupo paralelo, doble ciego. Lugar: Servicio de Medicina Interna, Hospital I EsSalud, ciudad de Tingo María, Departamento de Huánuco. Pacientes: Pacientes con diagnóstico de diab...

Eficacia y seguridad de la melatonina para el manejo de los trastornos del sueño en el autismo: meta-análisis

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Rodríguez T., María del Rosario; Méndez Álvarez, Liliana P.; Jairo M., González Díaz

2016-01-01

INTRODUCCIÓN: El 80% de los niños y adolescentes con trastornos del espectro autista (TEA) presenta algún trastorno del sueño, en cuya génesis al parecer intervienen alteraciones en la regulación de la melatonina. El objetivo de este metaanálisis fue determinar la eficacia y seguridad de la melatonina para el manejo de ciertos trastornos del sueño en niños con TEA. MÉTODOS: Tres revisores extrajeron los datos relevantes de los ensayos clínicos aleatorizados doble ciego de alta ...

Edición 2015 Volumen 17 Nro 03

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Escobar Mamani, Fortunato; Universidad Nacional del Altiplano Puno Peru; Collantes Menis, Nestor; Universidad Nacional del Altiplano

2015-01-01

Los editores de la Revista Investigaciones Altoandinas  (Journal of High Andean Research) de la Universidad Nacional del Altiplano, a través de Vice Rectorado de Investigación se complacen en presentar la presente edición en su Vol- 17 N° 03 correspondiente al tercer trimestre del año 2015 (de tres publicaciones al año).  La Revista a consideración, es resultado de propuestas llegadas a nuestra oficina, los mismos que fueron sometidos a una revisión por pares (modalidad doble ciego) de confor...

Mastalgia cíclica pré-menstrual: placebo versus outras drogas Pre-menstrual cyclic mastalgia

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Laurival A. De Luca

2006-08-01

Full Text Available Os autores definem mastalgia cíclica pré-menstrual, (MCPM, repassam os principais mecanismos do ciclo celular da mama, e com base nestes conhecimentos propõem a sua classificação em três tipos, segundo a fisiologia do ciclo mamário: tipo 1 - caracterizado pela distensão localizada de ductos e adensamento do tecido conjuntivo em volta de pequenas dilatações. tipo II - caracterizado pelo edema intersticial, e tipo III - caracterizado pela combinação dos dois processos etiopatogênicos. OBJETIVO: Por meio de estudo prospectivo, aleatório, triplo cego e controlado, comparar a ação de placebo com associação de vitaminas A-D-E e doses baixas de ácido acetilsalicílico. MÉTODOS: Foram observadas 259 portadoras de MCPM, acompanhadas durante seis meses para estudo comparativo das drogas empregadas no alívio da dor. Destas, foram selecionadas 81 pacientes por critérios rigorosos, divididas em três grupos de 27, que receberam, respectivamente, aspirina, associação de vitaminas e placebo. A dor foi classificada em grau I (sem dor, grau II (dor moderada e grau III (dor intensa. Os métodos estatísticos realizados mostraram que o número de pacientes em cada grupo era satisfatório. Foi empregado o teste de Tukey para comparação dos resultados e significância a 5%. RESULTADOS: As características clínicas, idade, peso, altura e IMC, antecedentes obstétricos e duração da amamentação foram semelhantes nos três grupos. Houve redução de intensidade da dor nos três grupos, principalmente naquele que recebeu placebo. CONCLUSÃO: O estudo realizado, segundo metodologia aceitável, porque foi prospectivo, controlado, triplo cego e aleatório, não mostrou diferenças significativas no tratamento da mastalgia cíclica pré-menstrual entre aspirina e associação de vitaminas, mas revelou superioridade do placebo.OBJECTIVES: To compare therapeutic effects of placebo with intake of low doses of acetyl-salysilic acid (aspirin and a

Tipología de las explotaciones ganaderas de bovinos doble propósito en Sinaloa, México

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Venancio Cuevas Reyes

2016-01-01

Full Text Available El objetivo del presente estudio consistió en realizar una tipología de las explotaciones ganaderas de bovinos de doble propósito en el estado de Sinaloa, usando variables sociales, económicas y tecnológicas. Se analizó información de 1,165 productores del sistema de producción de doble propósito que participaron en el programa Soporte de SAGARPA 2010-2011. A través del uso de componentes principales, análisis cluster y análisis de varianza fueron identificados y caracterizados cuatros tipos de explotaciones ganaderas; pequeñas explotaciones ganaderas (67 %, explotaciones ganaderas medianas (24 %, explotaciones ganaderas grandes (7 %, y explotaciones ganaderas grandes con potencial empresarial (2 %. La tipología obtenida puede ser útil para generar políticas públicas diferenciadas que incrementen el uso de innovaciones tecnológicas que incidan en una mayor eficiencia y productividad del sistema bovinos de doble propósito en Sinaloa.

Efectividad de la movilización neuromeníngea frente a la efectividad del ejercicio terapéutico en pacientes con lumbociática crónica.

OpenAIRE

Val Sánchez, Natalia del

2010-01-01

La lumbociática crónica es una afectación de las raíces L4-L5, L5-S1 del nervio ciático cuyas manifestaciones clínicas: dolor, alteraciones sensitivas, motoras y de reflejos, se mantienen durante tres o más meses; es una patología que afecta al 40% de la población en países desarrollados y causa frecuente de absentismo laboral. El objetivo principal del estudio piloto aleatorizado controlado a simple ciego, es comparar la efectividad de la Movilización Neuromeníngea del nervio ...

Efecto de la intervención fisioterapéutica sobre los signos de bruxismo y la postura cefálica en niños

OpenAIRE

Tamayo Montoya, Verónica

2009-01-01

Tesis de grado (Maestría en Educación y Desarrollo Humano). Centro Internacional de Educación y Desarrollo humano -Cinde-Universidad de Manizales. Facultad de Ciencias Sociales y Humanas, 2009 Diseño y Objetivo: se realizó un ensayo clínico controlado aleatorizado ciego, que tuvo como objetivo evaluar la efectividad de una intervención fisioterapéutica para mejorar la postura de la cabeza y los signos de bruxismo en niños y niñas. Materiales y Métodos: todos los sujetos debían tener entre ...

Radionuclide content in building materials in Camaguey and Ciego de Avila provinces of Cuba

International Nuclear Information System (INIS)

Brigido Flores, O.; Montalvan Estrada, A.; Barreras Caballero, A. A.; Queipo Garcia, M.; Tomas Zerquera, J.

2001-01-01

A study was initiated by the Environmental Radioactivity Laboratory, three years ago, to estimate the various natural radiation components that contribute to the annual effective dose to the population of Camaguey and Ciego de Avila. The natural radioactivity of some building materials commonly used in the above mentioned provinces of Cuba was measured by gamma spectrometry. Typical concentrations, so far encountered, are in the ranges: 47 to 2511 Bq.kg-1 for 40K; 9 to 71 Bq.kg-1 for 226Ra; and 2 to 38 Bq.kg-1 for 232Th. The relationship between the activity concentration and the corresponding annual effective dose is a function of many parameters. The external gamma ray absorbed doses in indoor air, and the corresponding effective dose equivalents in a typical dwelling are presented in this paper

Principio de proporcionalidad y principio de Doble Efecto. Una propuesta desde la Filosofía del Derecho

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Cristóbal Orrego-Sánchez

2015-01-01

Full Text Available El artículo propone, desde la perspectiva de la filosofía del derecho, un complemento del principio de proporcionalidad, acogido por una parte de la dogmática constitucional y de los tribunales constitucionales o internacionales que adjudican sobre derechos humanos, mediante el principio de doble efecto, clásico en la filosofía moral. Primero, plantea el problema de los análisis de proporcionalidad para la filosofía del derecho, en su aspecto fundamentalmente crítico y ético-político. Después, presenta el principio de doble efecto, de acuerdo con las investigaciones más recientes. Enseguida, sintetiza el principio de proporcionalidad, acudiendo también a algunas obras representativas de la dogmática constitucional. Finalmente, sugiere algunas comparaciones y formas de retener el principio, no obstante sus límites, mejorando su uso mediante la incorporación expresa del principio de doble efecto en la adjudicación constitucional sobre la protección de derechos fundamentales.

INTUSUSCEPCIÓN CECOCÓLICA E INVAGINACIÓN DEL CIEGO EN UN CANINO: REPORTE DE CASO

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J.F. Ortiz

2011-01-01

Full Text Available Se expone el caso de un perro mestizo de Fox Terrier que presentaba diarrea sanguino-lenta que no mejoró al tratamiento inicial; se detectó a la palpación una masa a nivel del colon, que se confirmó con un estudio radiográfico de tránsito intestinal; también, se diagnosticó un megacolon. Se decidió realizar una laparotomía exploratoria donde se encontró una intususcepción cecocólica y la invaginación del ciego, el procedimiento quirúrgico realizado consistió en hacer tiflectomia y enteroanastomosis término-terminal; luego de este procedimiento, el paciente se recuperó completamente del cuadro intestinal que presentaba.

Sistema de codificación y análisis de la calidad del dato en el tenis de dobles

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Javier Oscar Garay Plaza

2006-01-01

Full Text Available En el presente trabajo se desarrolla un nuevo instrumento de observación que tiene por objeto codificar la acción de juego en el tenis de dobles. Esta herramienta se genera en el marco de la Metodología Observacional. Considerando el tenis de dobles como un deporte de colaboración-oposición, se efectuó el registro de diversas clases de comportamiento estratégico en términos de interacción entre las parejas de un partido de tenis de dobles y desarrollado en un contexto espacial. La perspectiva de investigación fue fundamentalmente empírico inductiva. La utilización de distintos procedimientos tales como la concordancia consensuada y el análisis de generalizabilidad en el transcurso de todo el proceso hizo viable el control y garantía de la calidad del dato.

Clomipramina frente a fenelzina en el trastorno obsesivo-compulsivo

OpenAIRE

Vallejo Ruiloba, Julio; Olivares Gadea, Julia; Marcos, Teodor; Bulbena Vilarrasa, Antonio; Menchón Magriñá, José Manuel

1994-01-01

Un estudio clínico doble ciego con clomipramina frente a fenelzina fue llevado a cabo en 30 pacientes con trastorno obsesivo-compulsivo según el DSM-III. El período de estudio fue de 12 semanas, y las dosis máximas (a partir de la 5a semana) fueron 225 mg/día para clomipramina (14 pacientes) y 75 mg/día para fenelzina (12 pacientes); 4 pacientes abandonaron. Los síntomas obsesivos mejoraron significativamente en los dos grupos, pero no fiubo diferencia significativa entre ambos. Los síntomas ...

EVALUACIÓN DE LAS TÉCNICAS DE CEPILLADO DE BASS Y VERTICAL EN UN GRUPO DE PACIENTES EN TRATAMIENTO DE ORTODONCIA CON TÉCNICA MBT

OpenAIRE

Yelitza Ivone Baracaldo Ortíz; Fredy Alexander Cabuya Cabuya; Rubén Darío Hurtado Rozo; Edwin Emil Ricaurte Vila; Diana Constanza Gamboa Martínez; Liliana Carolina Báez Quintero

2012-01-01

Objetivo: Evaluar la efectividad de las técnicas de Cepillado de Bass y Vertical en pacientes con aparatología ortodóntica fija tratados con la técnica MBT. Materiales y métodos: se realizó un estudio experimental “In vivo” aleatorizado doble ciego; la muestra fue de 100 personas distribuidas en dos grupos, a cada uno se le asignó una Técnica de Cepillado y se dieron instrucciones de higiene oral por medio de charlas personalizadas y por escrito. Se usó el índice de Sillnes y Löe para medir e...

Efecto de la ingesta de un preparado lácteo con fibra dietética sobre el estreñimiento crónico primario idiopático The effect of a fibre enriched dietary milk product in chronic primary idiopatic constipation

OpenAIRE

J. López Román; A. B. Martínez Gonzálvez; A. Luque; J. A. Pons Miñano; A. Vargas Acosta; J. R. Iglesias; M. Hernández

2008-01-01

Objetivo: Determinar si la administración de un preparado lácteo enriquecido con un suplemento de fibra soluble (Naturfibra)®[inulina y maltodextrina resistente a la digestión (Fibersol 2®)], afecta a la sintomatología en el estreñimiento crónico primario idiopático. Ámbito: Sujetos de ambos sexos con estreñimiento según los criterios de Roma II. Sujetos: Se trata de un ensayo clínico doble ciego aleatorizado de intervención dietética realizado en 32 individuos con estreñimiento de ambos sexo...

Hidronefrosis prenatal en doble sistema excretor Prenatal hydronephrosis in double excretory system

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Sandalio Durán Álvarez

2007-12-01

Full Text Available Con la introducción del ultrasonido materno-fetal en el seguimiento sistemático del embarazo normal se detectan anomalías congénitas en el 1 % de los fetos, el 20 % de las cuales corresponden al tracto urinario. Se realizó el estudio de recién nacidos y lactantes con hidronefrosis prenatal, cuyos ultrasonidos materno-fetales demostraron la presencia de un doble sistema excretor. Para este propósito todos los recién nacidos y lactantes con hidronefrosis detectada prenatalmente, y doble sistema excretor diagnosticado antes o después del nacimiento, fueron seguidos mediante ultrasonografía renal evolutiva, uretrocistografía miccional, gammagrafía estática o dinámica y, en algunos casos, mediante urograma excretor. Hallamos doble sistema excretor en 7 de los 182 pacientes (3,8 % con anormalidades del tracto urinario diagnosticadas antes del nacimiento. El diagnóstico fue prenatal solo en uno de los fetos (31 semanas de embarazo. La dilatación hidronefrótica fue ligera en dos fetos y grave en cinco. La hidronefrosis obedeció a diferentes causas. Se realizó nefrectomía polar superior en los casos de ectopia ureteral y de uréter superior obstruido, reimplantación en un ureterocele, y en otro se comprobó la ruptura espontánea mediante endoscopia. Los restantes pacientes se trataron sintomáticamente. La hidronefrosis detectada antes del nacimiento mediante ultrasonografía materno-fetal puede estar asociada a un doble sistema excretor. La dilatación hidronefrótica asociada a un doble sistema puede deberse a diferentes causas, y es necesario estudiar cuidadosa y sistemáticamente a estos niños y tratarlos adecuadamente, porque cada uno puede necesitar una conducta diferente.With the introduction of the maternofetal ultrasound in the systematic follow-up of normal pregnancy, congenital anomalies are detected in 1 % of the fetuses, 20 % of which correspond to the urinary tract. The newborns and infants with prenatal

Revascularización miocárdica con uso de doble arteria mamaria interna y morbilidad esternal. Experiencia de un centro

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Sara Badia

2017-05-01

Conclusiones: En nuestra experiencia, la utilización de doble mamaria no se acompañó de mayor incidencia de dehiscencia esternal, pero si con problemas de infección superficial de la herida, sobre todo en el grupo de pacientes mujeres, con insuficiencia renal y transfundidos en quirófano. Para mantener el beneficio de la doble mamaria en estos pacientes, deberíamos ser especialmente cuidadosos e implementar nuevas estrategias de cierre esternal.

Tratamento da parada cardíaca experimental com adrenalina, vasopressina ou placebo

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Manoel Ângelo Gomes Palácio

2013-12-01

Full Text Available FUNDAMENTO: Na ressuscitação cardiopulmonar (RCP prolongada, o efeito dos vasoconstritores não foi plenamente esclarecido. OBJETIVOS: Avaliar o efeito pressórico da adrenalina e da vasopressina, e observar o retorno da circulação espontânea (RCE. MÉTODOS: Estudo prospectivo, randomizado, cego e placebo-controlado. Após sete minutos em fibrilação ventricular, porcos receberam ciclos de dois minutos de RCP. Tentou-se a desfibrilação (4 J/kg uma vez aos 9 minutos e após cada ciclo, conforme o ritmo verificado, reiniciando-se a RCP imediatamente. Aos 9 minutos e depois de cada cinco minutos, aplicou-se adrenalina 0,02 mg/kg (n = 12 porcos, ou vasopressina 0,4 U/kg (n = 12, ou solução salina 0,9% 0,2 mL/kg (n = 8. A RCP continuou por 30 minutos ou até o RCE. RESULTADOS: A pressão de perfusão coronária aumentou para aproximadamente 20 mmHg nos três grupos. Com os vasoconstritores, a pressão alcançou 35 mmHg versus 15 mmHg com placebo (p < 0,001. Com vasopressina, manteve-se efeito de 15-20 mmHg após três doses versus zero com adrenalina ou placebo. Observou-se o RCE com frequência diferente (p = 0,031 entre adrenalina (10/12, vasopressina (6/12 e placebo (2/8. O tempo médio até o RCE não diferiu (16 minutos, nem o número de doses recebidas até então (uma ou duas. Entre os vasoconstritores não houve diferença significante, mas, frente ao placebo, apenas a adrenalina aumentou significantemente o RCE (p = 0,019. CONCLUSÃO: O efeito pressórico inicial dos vasoconstritores foi equivalente, e a vasopressina manteve um efeito tardio na ressuscitação prolongada. Apesar disso, comparando-se ao placebo, apenas a adrenalina aumentou significantemente a frequência do retorno da circulação espontânea.

Alta precoz postparto. Evaluación de las complicaciones maternas y neonatales; repercusión en la ansiedad materna

OpenAIRE

Goyeneche Lasaga, Leire

2014-01-01

246 p. Ensayo clínico controlado aleatorizado simple ciego, sin medicamento, fase IV, unicéntrico donde se comparó el alta precoz a las 24 horas del parto y una visita hospitalaria a las 48h del alta, con el alta habitual a las 48-72 horas. Para ello se incluyeron un total de 416 mujeres sanas y mayores de edad que habían dado a luz por vía vaginal a un RN único, sano y a término entre el 1 de Octubre del 2012 y el 19 de Septiembre del 2013 en el Hospital Universitario Donostia; 208 fueron...

Qualidade de vida de pacientes com câncer colorretal em uso de suplementação dietética com fungos Agaricus sylvaticus após seis meses de segmento: ensaio clínico aleatorizado e placebo-controlado Quality of life of patients with colorectal cancer on dietary supplementation with Agaricus sylvaticus fungus: after six months of segment: randomized and placebo-controlled clinical trial

Directory of Open Access Journals (Sweden)

Renata Costa Fortes

2007-06-01

Full Text Available INTRODUÇÃO: O câncer gastrointestinal compromete a qualidade de vida devido às alterações fisiológicas, metabólicas e psicológicas. Fungos medicinais podem melhorar a qualidade de vida de pacientes com câncer. OBJETIVO: Avaliar os efeitos da suplementação dietética com fungos Agaricus sylvaticus na qualidade de vida de pacientes com câncer colorretal em fase pós-operatória. METODOLOGIA: Ensaio clínico randomizado, duplo-cego, placebo-controlado, realizado no Hospital de Base do Distrito Federal. Amostra constituída por 56 pacientes (24 homens e 32 mulheres, estádios I, II e III, separados em grupos placebo e Agaricus sylvaticus (30mg/kg/dia, e acompanhados por um período de seis meses. Para avaliar os indicadores da qualidade de vida foram utilizados um formulário-padrão e uma anamnese dirigida-padrão. Os resultados foram analisados de forma qualitativa e descritiva, utilizando os programas Microsoft Excel 2003 e Epi Info 2004. RESULTADOS: Após seis meses de tratamento, observou-se, no grupo Agaricus sylvaticus, aumento da adesão à prática de atividade física, melhora da disposição e do humor, redução das queixas de dores e das alterações do sono como insônia e noites mal dormidas comparado com o grupo placebo. CONCLUSÃO: Os resultados sugerem que a suplementação dietética com Agaricus sylvaticus pode melhorar a qualidade de vida de pacientes no pós-operatório de câncer colorretal.INTRODUCTION: Gastrointestinal cancer jeopardizes the quality of life through physiological, metabolic and psychological alterations. Medicinal fungus may boost the quality of life of patients with cancer. OBJECTIVE: To evaluate the effects of the dietary supplementation with Agaricus sylvaticus fungus in relation to the quality of life in patients with colorectal cancer during post-surgery phase. METHODOLOGY: Randomized, double-blind, placebo-controlled clinical trial carried out at the Federal District Hospital - Brazil, for

Diseño, cálculo y comprobación de unión soldada en viga de puente grúa de alma doble

OpenAIRE

Fraile Griborio, Francisco J.

2011-01-01

El trabajo se basa en el diseño y la comprobación de las uniones soldadas en una viga con alma doble que servirá como Puente Grúa. Partiendo de un ejemplo particular de una viga con alma doble (definido por la longitud, la carga máxima y las características químicas y mecánicas de las chapas metálicas) se ha realizado el pre‐dimensionado de la estructura utilizando un programa de cálculo (SAP2000). Los resultados se han comprobado mediante un modelo teórico de cálculo para vigas con alma dobl...

Curva de intensidad frecuencia y duración de inundaciones (IFD) para el municipio Venezuela, provincia Ciego de Ávila, Cuba

OpenAIRE

Oscar Brown Manrique; Yurisbel Gallardo Ballat; José E. Valdés

2013-01-01

La investigacion se desarrolló en el minicipio de Venezuela de la provincia de Ciego de Ávila, con el proposito de construir las curvas de intensidad frecuencia duracion de las inundaciones sobre la base de las precipitaciones efectivas de esa localidad y su ajuste a las funciones de Talbot y Aparicio. Se determinaron igualmente el índice de precipitación efectiva normal (IPN) de gran utilidad para la determinacion de la intensidad de este fenómeno. Los resultados demuestran que las precipita...

La ceguera como motivo en Ensayo sobre la ceguera de José Saramago e Informe sobre ciegos de Ernesto Sábato

OpenAIRE

Fonseca, Marco Antonio

2008-01-01

El trabajo de investigación, El motivo de la ceguera en el Ensayo sobre la ceguera de José Saramago e Informe sobre ciegos de Ernesto Sábato, analiza desde el área y la metodología de la literatura comparada el uso del motivo literario de la ceguera en los dos textos mencionados, resaltando las similitudes y diferencias del tratamiento del motivo dentro de las dos obras y como éste sostiene una serie de obsesiones e ideas sobre el estado actual del mundo que comparten los autores de las dos n...

Curva de intensidad frecuencia y duración de inundaciones (IFD) para el municipio Venezuela, provincia Ciego de Ávila, Cuba

OpenAIRE

Brown Manrique, Oscar; Gallardo Ballat, Yurisbel; Valdés, José E.

2013-01-01

La investigación se desarrolló en el municipio de Venezuela de la provincia de Ciego de Ávila, con el propósito de construir las curvas de intensidad frecuencia duración de las inundaciones sobre la base de las precipitaciones efectivas de esa localidad y su ajuste a las funciones de Talbot y Aparicio. Se determinaron igualmente el índice de precipitación efectiva normal (IPN) de gran utilidad para la determinación de la intensidad de este fenómeno. Los resultados demuestran que las precipita...

Acupuntura na fibromialgia: um estudo randomizado-controlado abordando a resposta imediata da dor

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Rebecca Saray Marchesini Stival

2014-12-01

Full Text Available Objetivo Avaliar a eficácia da acupuntura no tratamento da fibromialgia, considerando-se como desfecho primário a resposta imediata da escala visual analógica (VAS para avaliação da dor. Material e métodos Estudo randomizado, controlado e duplo-cego incluindo 36 pacientes portadores de fibromialgia (ACR 1990 selecionados no ambulatório de Reumatologia da Santa Casa de Misericórdia de Ponta Grossa, PR. Vinte e um pacientes foram submetidos a uma sessão de acupuntura, nos moldes da Medicina Tradicional Chinesa, e 15 pacientes foram submetidos a um procedimento placebo (acupuntura sham. Para avaliação da dor, os indivíduos preencheram uma Escala Visual Analógica (VAS antes e imediatamente após o procedimento proposto. As médias na variação da VAS foram comparadas entre os grupos. Resultados A variação entre o valor da EVA final e da EVA inicial foi de –4,36±3,23 (P=0,0001 no grupo de tratamento e de –1,70±1,55 no grupo de controle (P=0,06. A diferença na amplitude de variação da EVA (EVA inicial – final entre os grupos favoreceu o procedimento verdadeiro (P=0,005. O tamanho de efeito (effect size – ES para o grupo de tratamento foi de d=1,7, o que é considerado um efeito grande. Embora com uma amostra reduzida, seu poder estatístico para esses resultados foi bastante relevante (94,8%. Conclusão A acupuntura mostrou ser eficaz na redução imediata da dor em pacientes portadores de fibromialgia, com um tamanho de efeito (effect size bastante significativo.

Pulsioxymetry monitorization during lower third molar extraction. A comparative study of three local anesthetics with epinephrine 1:100.000

OpenAIRE

Mestre Aspa, Regina; Carrera Grañó, Imma; Berini Aytés, Leonardo; Gay Escoda, Cosme

2001-01-01

El objetivo de este estudio fue comparar la frecuencia cardíaca y la saturación de oxígeno bajo el efecto de tres anestésicos locales diferentes, con la misma concentración de epinefrina, durante la extracción de un tercer molar inferior en pacientes sanos. Los anestésicos locales utilizados fueron articaína al 4%, lidocaína al 2% y mepivacaína al 2%, los tres con una concentración de epinefrina de 1:100.000. Se diseñó un estudio de doble ciego, paralelo y no aleatorizado. Los pacientes fuero...

Characterization of the neoplastic disease in childhood in the province of Ciego de Avila

International Nuclear Information System (INIS)

Perez Calleja, Norma C

2010-01-01

We conducted a cross-sectional descriptive study to characterize from the standpoint of childhood cancer epidemiology in the province of Ciego de Avila from January to December 2008. The sample consisted of all the managers or guardians, with inclusion criteria and signed informed consent. We applied a structured interview criteria validated by experts. The data were divided into tables and comments. Acute leukemias were most prevalent. The northern area had a higher proportional mortality and crude with 10.7 x c/100 people died and 0.05 respectively x c/1000 plus higher incidence rate, with 0.8 x c/10000 inhabitants. The higher prevalence of cancer diseases in the municipality of the chamber. The specific rates were in the group of 1 to 4 years and only 16.3% underwent early diagnosis of the disease. We conclude that working in the promotion, teaching and research to reduce childhood cancer mortality in the province

Material compuesto electroconductor con coeficiente de expansión térmica controlado

OpenAIRE

Borrell, Amparo; García Moreno, Olga; Fernández, Adolfo; Torrecillas, Ramón

2009-01-01

Material compuesto electroconductor con coeficiente de expansión térmica controlado. La presente invención se refiere a un material compuesto que comprende un componente cerámico, caracterizado por tener un coeficiente de expansión térmico negativo, y nanofilamentos de carbono, a su procedimiento de obtención y a sus usos como electroconductor en microelectrónica, óptica de precisión, aeronáutica y aeroespacial.

Administración oral de preparado parenteral de vitamina K en anticoagulación excesiva por warfarina Oral administration of intravenous preparation of Vitamin K for excessive anticoagulation due to warfarin

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Yoleima Lozada

2012-04-01

Full Text Available La warfarina es frecuentemente usada en la terapia anticoagulante actual, su acción debe ser monitorizada usando el tiempo de protrombina expresado como International Normalized Ratio (INR; cuando se excede el rango de seguridad se puede administrar vitamina K (Vit-K, preferentemente por vía oral. Dicha presentación no está disponible en Venezuela. Se realizó un ensayo clínico, doble ciego, donde a 20 pacientes, edad 18-60 años, sin sangrado e INR inicial de 6 a 10 inclusive; les fue suspendida la warfarina e inmediatamente agrupados al azar a recibir dosis única de Vit-K (oral 1.25mg de Vit-K fraccionada de una presentación parenteral o placebo. El punto final primario, INR Anticoagulation therapy with warfarin, a common clinical practice, needs to be monitored using protombine time expressed as the International Normalized Ratio (INR; when safety range is exceeded, Vitamin K (Vit-K could be administered with preference orally. In Venezuela the specific oral preparation for Vit-K is not available. This is a double blinded, randomized, placebo controlled, clinical trial; 20 patients, age 18-60 year with initial INR ≥ 6, ≤10, were randomized to oral Vit-K 1.25mg (prepared from intravenous presentation or placebo plus withholding warfarin. INR < 3.5 at 24 hours of treatment (the primary end point was achieved by 70% among Vit-K, and 20% among placebo patients; given an absolute risk reduction (ARR, of 50% (CI95%: 14.4-85.6 ρ = 0.028, NNT 2 (CI95%: 1.3 - 6.9. No adverse events were recorded including INR < 2 at 24 hours of treatment administration. Our results are consistent with studies where specific oral presentation of Vit-K was used. The results indicate that oral administration of Vit-K, prepared from an intravenous Vit-K preparation, is safe and more effective to revert excessive anticoagulation than simply withholding warfarin, in places where specific preparation of oral Vit-K is not available or too expensive.

Experimentos controlados y educación en ingeniería de software

OpenAIRE

Zapata, Sergio G.; Aballay, Laura N.; Sevilla, Gustavo A.

2010-01-01

Mediante los métodos empíricos es posible evaluar nuevos aportes de la Ingeniería de Software antes de ser incorporados en los procesos de desarrollo de software de las empresas. Resulta favorable que la educación superior aplique métodos empíricos en el proceso de enseñanza y formación de los estudiantes. Este artículo presenta el resultado de un análisis, desde la perspectiva educativa, de cuatro experimentos controlados realizados por profesores de la Universidad Nacional de San Juan en as...

Experiencias de la Corporación Universitaria Adventista en la doble titulación académica

OpenAIRE

Iglesias, Enoc; Corporación Adventista

2015-01-01

En el presente articulo no derivado de investigaciones, se muestran varios aspectos de las experiencias que ha tenido la Corporación Universitaria Adventista en la doble titulación, tema de gran actualidad.

Impact of recombinant human growth hormone (rh-GH treatment on psychiatric, neuropsychological and clinical profiles of GH deficient adults: a placebo - controlled trial Impacto do tratamento com hormônio de crescimento recombinante (rh-GH sobre as características psiquiátricas, neuropsicológicas e clínicas de adultos com deficiência de GH: ensaio clínico duplo-cego controlado com placebo

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CLÁUDIO DE NOVAES SOARES

1999-06-01

Full Text Available BACKGROUND: Untreated GH-deficient adults have a diversity of dysfunctions (e.g. reduced muscle strength, emotional instability during stress, depressive symptoms that may cause deleterious effects on quality of life, and may be positively influenced by recombinant human growth hormone (rh-GH therapy. AIM: To evaluate the impact of a clinical intervention with rh-GH therapy on GH - deficient adults. METHOD: The physical, psychiatric and neuropsychological status of 9 GH-deficient adults was determined before and after the administration of rh-GH (0.250 IU/Kg/week in a double blind placebo-controlled trial for six months. Patients then received rh-GH for a further period of 6 months and their status was re-evaluated. RESULTS: Rh-GH was significant better than placebo at 6th month (pINTRODUÇÃO: Pacientes com deficiência de hormônio de crescimento (GH apresentam diversas alterações clínicas (ex: redução de massa muscular e de função cardíaca e psíquicas (ex: quadros fóbicos, sintomas depressivos, déficits cognitivos. OBJETIVO: Avaliar o impacto da terapêutica com rh-GH em adultos com deficiência de GH. MÉTODO: Nove pacientes foram diagnosticados com deficiência de GH e então submetidos a ensaio clínico, duplo-cego, controlado, recebendo rh-GH (0,250UI/Kg/semana ou placebo, por período de 6 meses. RESULTADOS: Houve melhora significativa (p<0,05 em parâmetros clínicos ( aumento de massa muscular, redução do índice de massa corpórea (BMI, aumento de gasto energético, psiquiátricos (sintomas depressivos avaliados pelas escalas de Beck e Hamilton (p= 0,043 e neuropsicológicos (testes de atenção (p= 0,035, fluência verbal (FAS: p= 0,02, além da melhora de eficiência cognitiva (testes do WAIS-R: vocabulário (p= 0,027 , Arranjo de Figuras (p= 0,017, Compreensão (p= 0,01 . CONCLUSÃO: Prejuízos clínicos, psíquicos e neuropsicológicos causados pela deficiência de GH em adultos podem ser reduzidos pela terap

[Not Available].

Science.gov (United States)

San Mauro-Martín, Ismael; Collado-Yurrita, Luis; Blumenfeld-Olivares, Javier Andrés; Cuadrado-Cenzual, María Ángeles; Calle-Purón, María Elisa; Hernández-Cabria, Marta; Garicano-Vilar, Elena; Pérez-Arruche, Eva; Arce-Delgado, Esperanza; CiudadCabañas, María José

2016-06-30

Introducción: la hipercolesterolemia es uno de los principales factores de riesgo en la enfermedad cardiovascular. Los esteroles vegetales se han postulado como agentes reguladores y beneficiosos para el control de esta.Objetivo: analizar el efecto de los esteroles vegetales añadidos en una leche en la reducción del colesterol plasmático en adultos jóvenes.Métodos: ensayo clínico, controlado, aleatorizado, doble ciego y cruzado. Los esteroles (2,24 g diarios) fueron administrados en dos tomas de 350 ml de una leche comercial desnatada, durante dos periodos de 3 semanas, separados por una "fase de lavado" de 2 semanas, en el grupo experimental. Al grupo control se le administró la misma cantidad de leche desnatada, sin esteroles. Tanto al inicio como al final de cadaperiodo de intervención se extrajeron muestras sanguíneas. Se analizaron la composición corporal, hábitos de salud y los siguientes marcadores sanguíneos: perfil lipídico, hematológico, inflamación, etc.Resultados: se incluyeron 54 personas en el estudio con una edad media de 38,8 ± 7,3 años. La diferencia porcentual entre los marcadores basales y finales para el colesterol total, colesterol-LDL, colesterol-HDL, triglicéridos y colesterol no-HDL fueron del 9,73%, 12,5%, 1,9%, 3,15% y 13,2%, respectivamente. Se obtuvieron diferencias estadísticamente significativas entre el grupo experimental y el grupo control, para todos los marcadores analizados excepto para los triglicéridos.Conclusión: los esteroles vegetales suministrados en un alimento de consumo habitual, como la leche, pueden ser una estrategia terapéutica no farmacológica para el control de la hipercolesterolemia de alto interés sanitario.

Sistema de gestión de KOS : vocabularios controlados y Light ontologies

OpenAIRE

López Gómez, Borja

2012-01-01

El objetivo del proyecto es desarrollar un módulo de gestión de un sistema de organización del conocimiento (KOS) basado en la administración de un vocabulario controlado y ontologías ligeras, con el fin de buscar la máxima calidad de los requisitos escritos a posteriori por compañías de desarrollo software. Se realiza un estudio previo de las necesidades del cliente y las posibles soluciones actuales del mercado. Además, se describe la teoría necesaria sobre sistemas de organización del cono...

Comportamiento de cinco grupos de genotipos de maíz Zea mays L. con dos tipos de grano en dos condiciones de almacenamiento

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Orozco Javier

1995-12-01

Full Text Available

The corn seed quality damage was evaluated in materials with different genetic constitution (imbreeding lines, simple double- triple hybrids and varieties, and two grain shapes (plane, round when they were storaged for 2-12 months in two environments (controled : 50% at relative humidity and Temperature at 16°C and no-controled with relative humidity between 40-98% and temperature at 16-33°C. Controled environments, the seed was more resistance at storage for four months that no-controled conditions with germination percentages upper 90% (acceptation limiter tolerable for commercial seeds in Colombia. The plane grains can be stored four months more that round seed. The order of tolerance to storage controlled condition is as follow: Inbred lines > Three ways hybrids > Single hybrids > Double hybrids > Varieties.

Informe sobre ciegos:de la narración de Ernesto Sabato a la alucinación gráfica de Alberto Breccia

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Giulia De Sarlo

2015-07-01

Full Text Available Alberto Breccia has been one of the fathers of twentieth century graphic narrative. Author of key works as El Eternauta (1969, his forays into the world of literature have been frequent since his début. At the end of his life, Breccia turned into comic the Informe sobre ciegos, central and autonomous chapter of Sobre héroes y tumbas (1961 by Ernesto Sabato. This work will analyse the dialogue that the graphic genius of Breccia establishes with the tormented Sabato’s voice, enriching the meaning of one of the most controversial passages of recent Latin American literature.

Cirugía coronaria con doble arteria mamaria: nuestra experiencia inicial y resultados a corto plazo

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Jorge Alcocer-Diéguez

2017-05-01

Conclusiones: La cirugía coronaria con doble mamaria es una técnica segura y con excelentes resultados de morbimortalidad a corto plazo. Son necesarios estudios de seguimiento clínico y angiográfico a largo plazo para determinar la mejor estrategia quirúrgica a emplear.

Impacto farmacoeconómico de la revisión diaria de la prescripción de antibióticos controlados

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Katherine Romero Viamonte

Full Text Available Objetivo: valorar la eficacia de la revisión diaria de las prescripciones de antibióticos controlados (incluida su justificación de uso en el Servicio de Observación en el aumento de la calidad asistencial y en la disminución de los costos hospitalarios. Métodos: estudio prospectivo de las solicitudes de antibióticos controlados recibidas en el Departamento de Farmacia del Hospital General Docente "Dr. Agostinho Neto" de Guantánamo, en el periodo de mayo a noviembre de 2011. El universo de estudio estuvo conformado por los 1 295 pacientes que recibieron la terapia. Resultados: predominaron las prescripciones de ceftriaxona y ciprofloxacina. Los servicios que más lo utilizaron fueron: unidades de urgencias médicas y Cirugía. El 17 % de las indicaciones resultaron inadecuadas. Se suspendió el 9 % de los tratamientos, el 6 % fue cambiado por otro antibiótico y en el 2 % se modificó la dosis. Se logró que la totalidad de los pacientes en el Servicio de Observación utilizaran este tipo de medicamento una vez demostrado su criterio de ingreso en sala. Conclusiones: el método implementado contribuyó al alcance de beneficios farmacoterapéuticos para los pacientes y una disminución considerable de los costos por concepto de utilización de antibióticos controlados.

Desarrollo de un Efecto de Sonido controlado mediante un acelerómetro

OpenAIRE

Naami, Amnay

2015-01-01

En este TFG se propone un nuevo procedimiento para accionar un efecto de sonido wah-wah basado en el uso de un acelerómetro que detecta el movimiento del pie del músico, sin necesidad de accionar directamente una plataforma. El efecto de sonido estaría formado por el acelerómetro, un circuito de detección de la señal del acelerómetro y generación de una señal de control que actúa sobre un filtro controlado por tensión (VCF) y el propio VCF, cuya frecuencia de corte depende de la señal d...

Caracterización hidroquímica del Gran Humedal del Norte, Ciego de Ávila, Cuba/ Hydrochemical characterization of the Northern Great Wetland, Ciego de Ávila, Cuba

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Homero Menéndez-Pérez

2011-10-01

Full Text Available

Se realizó una caracterización hidroquímica de las bahías interiores Los Perros y Jigüey, del Gran Humedal del Norte de Ciego de Ávila para establecer los factores que provocan modificaciones en las propiedades físico-químicas del ambiente hídrico y el estado de conservación o de deterioro actual del acuatorio. El comportamiento espacio-temporal de la temperatura, salinidad, porcentaje de saturación de oxígeno y pH se evaluó a partir de los resultados analíticos de once muestras de agua y de los mapas de distribución espacio-temporal generados en Surfer 8.0. Se encontró que en las bahías interiores Los perros y Jigüey el intercambio con el agua del océano, la profundidad de fondo del acuatorio y, en menor medida, el escurrimiento superficial de las aguas son los factores que más influyen en el comportamiento espacio-temporal de las propiedades analizadas, por lo que se recomienda conectar las lagunas interiores con las aguas del océano para favorecer la disminución de la salinidad, el aumento del pH y temperaturas más estables durante todo el año.

Materiales composites micro- y nano-estructurados basados en hidróxidos dobles laminares de tipo hidrotalcita y silicatos de la familia de las arcillas.

OpenAIRE

Aranda, Pilar; Gómez Avilés, Almudena; Ruiz-Hitzky, Eduardo

2008-01-01

Materiales composites micro- y nano-estructurados basados en hidróxidos dobles laminares de tipo hidrotalcita y silicatos de la familia de las arcillas. La presente invención se refiere a materiales composites micro- o nano-estructurados basados en hidróxidos dobles laminares de tipo hidrotalcita y silicatos de la familia de las arcillas. La invención también se refiere al procedimiento de preparación de estos materiales así como a su uso en aplicaciones diversas tales...

Análisis del lenguaje controlado en tres bases de datos internacionales = A controlled language analysis in three international databases

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Purificación Moscoso

2000-06-01

Full Text Available Se analiza el lenguaje controlado utilizado para la indización de tres bases de datos internacionales de Ciencias Sociales, utilizando los parámetros fundamentales que deben regir todo proceso de indización: la relevancia, la consistencia y la exhaustividad. Asimismo, se comparan los resultados obtenidos en el análisis de los lenguajes controlados post-coordinados y pre-coordinados de cara a la recuperación de información por materias. Estos resultados constatan la mayor idoneidad del uso de descriptores frente a encabezamientos de materia en los entornos automatizados = This paper analyses the indexing of three Social Sciencies International databases taken into consideration relevance, consistency and exhaustivity of the vocabulary used in the controlled languajes. Post-coordinated languaje and pre-coordinated languaje are compared, and results identify the coherence of the use of descriptors versus subject headings.

[The concept of placebo and the effect of placebo].

Science.gov (United States)

Göka, Erol

2002-01-01

The discussions about what placebo means and how its effect occurs go far back in the history of medicine. In general medicinal understanding, placebo means the subjective feeling of a positive effect in response to something that is used for curative intentions. In spite of difficulties in its definition and unknown content, its existence is generally accepted. What is discussed is its level of effectiveness in any disorder and medication. The placebo effect varies not only among diseases but also among regions and countries. Even the physicians' belief in a placebo increases its effect. Another interesting point about the placebo is its side effects. In many placebo controlled studies, the side effects of the placebo are found to be greater than those of real drugs. Different from other diseases, psychiatric disorders have strong connections with the placebo effect. The results of many studies support this idea. The increasing importance of placebos in psychiatry is really an interesting subject. For some people, the reason for this is hidden in the nature of psychiatric diseases. However, nonpharmacologic placebos such as "inspiration", "convincing", "confidence", and "belief" are believed to play a central role in psychiatry. In this article, placebo (the placebo effect) is defined, the implications of placebo in general medicine or psychiatry are discussed, and specific or nonspecific treatment methods are explained. The effects of a placebo on both the patient and the physician are emphasized. The significance of the placebo effect in psychiatry is also mentioned; and a new point of view, based upon the importance of symbolization and satisfaction is introduced in treatment and related action mechanisms.

Nifedipine Asma y Nifedipina: estudio comparativo del efecto profiláctivo de la Nifedipina frente al Ketotifeno y placebo en Asma Alérgica Infantil

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Fernando Montoya

1988-02-01

affinity for the respiratory tract and better blocking effects are synthesized they might become the elective therapeutic choice for these patients.

Se presentan los resultados de un estudio doble ciego, al azar, que comparó los efectos de la Nifedipina, una dihidropiridina antagonista del calcio, de amplia utilización cardiovascular, con los del Ketotifeno y los de un placebo; cada uno de ellos fue administrado por vía oral cada 12 horas, durante 4 meses, a un grupo de 20 niños mayores de 5 años con asma alérgica de una evolución mínima de 2 años; el estudio se llevó a cabo en el Servicio de Alergias del Hospital Universitario San Vicente de Paúl, de Medellín, Colombia, entre julio de 1984 y diciembre de 1986. La Nifedipina produjo disminución de la frecuencia de las crisis en 17 pacientes (85% y de su intensidad y duración en 16 (80%; en esta misma proporción (80% se disminuyó el consumo de broncodilatadores; 18 pacientes (90% informaron efectos benéficos de la Nifedipina y la mejoría, evaluada por el médico, se halló en 14 (70%. No hubo con la Nifedipina modificaciones del pulso ni de la presión arterial ni, tampoco, de 14 pruebas de función pulmonar; los efectos secundarlos fueron mínimos y autolimitados. Los resultados obtenidos con la Nifedipina fueron estadísticamente semejantes a los del Ketotifeno y, los de ambos, significativamente superiores a los logrados con el placebo (p

Rasgos epidemiológicos de ciegos y débiles visuales por retinosis pigmentaria en la provincia Las Tunas Epidemiologic traits of the blind and visually handicapped due to retinitis pigmantosa in the province of Las Tunas

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Luisa González Hess

2003-06-01

Full Text Available Se estudiaron 325 pacientes con el diagnóstico retinosis pigmentaria en la provincia Las Tunas. De ellos, se encontró que el 24,9 y el 10 % eran ciegos y débiles visuales respectivamente, donde se obtuvo una tasa de ciegos por retinosis pigmentaria de 1,45 x 10 000 habitantes y de débiles visuales de 0,6 x 10 000 habitantes. El tipo de herencia que predominó en ambos grupos fue la autosómica recesiva.325 patients with the diagnosis of retinitis pigmentosa were studied in the province of Las Tunas. Of them, it was found that 24.9 % and 10 % were blind and visually handicapped, respectively. A rate of blind patients caused by retinitis pigmentosa of 1.45 x 10 000 inhabitants and of visually handicapped of 0.6 x 10 000 inhabitants was obtained. The type of inheritance predominating in both groups was the autosomal recessive inheritance.

Cobertura vacinal de adultos deficientes visuais e as características sociodemográficas

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Lorita Marlena Freitag Pagliuca

2014-01-01

Full Text Available Se evaluaran la cobertura vacunal y las características sociodemográficas de adultos deficientes visuales. Investigación exploratoria, descriptiva y cuantitativa, con 41 adultos de asociación de ciegos de Fortaleza-CE, Brasil, de febrero a mayo/2011. Se realizó entrevista con instrumento semiestructurado con nombre, sexo, escolaridad y situación vacunal. Los resultados señalaron grupo predominante del sexo masculino (63,41%; edad entre 20-49 años (95,92% y escolaridad secundaria (79,92%. Recordaron tener recibido vacuna doble tipo adulto (82,93%, tríplice viral (51,22%, fiebre amarilla (21,95%, influenza según estaciones (29,27% e, no recibieron pneumocócica y hepatitis B. Intervalos de confianza señalaron que la mayoría de las personas con deficiencia, según recuerdo, se encontraba vacunada con doble adulto y tríplice viral. Las personas con deficiencia visual no reciben cartilla de vacunación adecuada para lectura, están parcialmente inmunizadas y susceptibles a enfermedades inmunoprevinibles. Medidas de intervención de enfermería son necesarias para planes de acciones a las principales medidas de prevención.

Administración oral de preparado parenteral de vitamina K en anticoagulación excesiva por warfarina

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Yoleima Lozada

2012-04-01

Full Text Available La warfarina es frecuentemente usada en la terapia anticoagulante actual, su acción debe ser monitorizada usando el tiempo de protrombina expresado como International Normalized Ratio (INR; cuando se excede el rango de seguridad se puede administrar vitamina K (Vit-K, preferentemente por vía oral. Dicha presentación no está disponible en Venezuela. Se realizó un ensayo clínico, doble ciego, donde a 20 pacientes, edad 18-60 años, sin sangrado e INR inicial de 6 a 10 inclusive; les fue suspendida la warfarina e inmediatamente agrupados al azar a recibir dosis única de Vit-K (oral 1.25mg de Vit-K fraccionada de una presentación parenteral o placebo. El punto final primario, INR < 3.5 a las 24 horas de administrar la dosis, se alcanzó en 70% de los pacientes en Vit-K y 20% en placebo. La reducción absoluta del riesgo y su intervalo de confianza de 95%: RAR (IC95% = 50% (14.4 a 85.6 ρ = 0.028; NNT (IC95% = 2(1.3 a 6.9; no se registraron eventos adversos, ni INR < 2 luego de 24 horas de tratamiento. Los resultados obtenidos son consistentes con estudios donde se administró Vit-K en preparación específica para vía oral. Así la Vit-K en presentación parenteral, administrada por vía oral, es más efectiva y segura que simplemente detener la administración de warfarina para revertir la excesiva anticoagulación, en donde no exista presentación específica oral de Vit-K o ésta sea muy costosa.

Investigación en especialidades quirúrgicas

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Juan Viñas Salas

Full Text Available En este artículo los autores revisan las características específicas de la investigación en las especialidades quirúrgicas, sus problemas y diferencias en relación al resto de la investigación biomédica. Hacen especial hincapié en los temas más frecuentes a investigar en cirugía, sus defectos y la metodología. Argumentan que los estudios prospectivos randomizados a doble ciego no deben ser sobredimensionados, ya que presentan problemas metodológicos y bioéticos al aplicarlos a la cirugía. Los estudios prospectivos son los más utilizados por los cirujanos para el avance de las especialidades quirúrgicas.

Relación del régimen hídrico actual con algunos impactos ambientales en el gran humedal del norte de Ciego de Ávila.

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Vidal Olivera, V.M.; González-Abreu Fernández, R.

2010-01-01

Producto a las transformaciones que ha sufrido el Gran Humedal del Norte de Ciego de Ávila (GHNCA), con la inserción de obras hidráulicas y civiles a lo largo de los años, actualmente se puede apreciar el impacto ambiental a este ecosistema, a la biodiversidad en general y a otros asociados a él como son los manglares, ocasionados principalmente por las variaciones del régimen hidrológico en esta zona, por lo que en estos momentos se encuentra en marcha un proyecto territorial de ...

Recuperación del cromo y aluminio del licor de desecho (wl en forma de sales dobles

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Pedro R. Bassas-Noa

2006-03-01

Full Text Available El licor WL es un residual de la industria del níquel agresivo al medio ambiente por su acidez que contiene elementos metálicos de gran valor. Se propone un tratamiento para la separación con  hidróxido de amonio y la recuperación de la mayor cantidad de cromo y aluminio contenidos en el mismo. Se logra precipitar una mezcla de hidróxidos de aluminio que tratada con ácido sulfúrico permite obtener, por cristalización, la sal sulfato de aluminio y amonio dodecahidratada. Posteriomente se cristaliza la sal sulfato doble de cromo y amonio dodecahidratado. Se demuestra que el sulfato doble de cromo y amonio dodecahidratado y el sólido separado presentan características químicas que hacen posible su aplicación en la industria textil y de cerámica, entre otras. El esquema aplicado permite la recuperación de valores metálicos y la disminución del alto poder contaminante del licor de desecho WL.

Inmunogenicidad, inocuidad y eficacia de una vacuna tetravalente obtenida por recombinación genética de rotavirus aislados de monos rhesus y seres humanos en Belém, Brasil Immunogenicity, safety and efficacy of tetravalent rhesus-human, reassortant rotavirus vaccine in Belém, Brazil

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A. C. Linhares

1998-05-01

Full Text Available Se evaluó la inocuidad, inmunogenicidad y eficacia de una vacuna tetravalente obtenida por recombinación genética de rotavirus aislados de monos rhesus y seres humanos (RRV-TV (4 x 10(4 unidades formadoras de placas por dosis en un ensayo prospectivo, aleatorio, a doble ciego y controlado con placebo que se efectuó con 540 lactantes brasileños. Se administraron dosis de vacuna o de placebo a la edad de 1, 3 y 5 meses. No se observaron diferencias significativas en la frecuencia de diarrea o vómito en los bebés de ninguno de los dos grupos después de administrar la dosis correspondiente. De 2 a 3% de los vacunados tuvieron fiebre baja los días tercero a quinto después de recibir la primera dosis, pero no después de las dosis segunda o tercera. Se observó una respuesta de anticuerpos del tipo IgA al rotavirus aislado de monos rhesus (RRV en 58% de los vacunados y en 33% de quienes recibieron placebo. La respuesta de anticuerpos neutralizantes a cada serotipo no pasó de 20% cuando se determinó con la prueba de reducción de focos de fluorescencia, pero fue superior a 40% al medirse con la prueba de neutralización a base de reducción de placas. Se presentaron 91 casos de diarrea causada por rotavirus entre los niños que recibieron las tres dosis (de vacuna o de placebo durante un seguimiento de 2 años, 36 de ellos en los niños vacunados. La eficacia general de la vacuna fue de 8% (P = 0,005 contra toda clase de diarrea y de 35% (P = 0,03 contra la diarrea causada por rotavirus. La protección durante el primer año de seguimiento, cuando predominó el rotavirus G del serotipo 1, fue de 57% (P = 0,008, pero se redujo a 12% en el segundo año. Se obtuvieron resultados similares al restringir el análisis a episodios en que el rotavirus fue el único agente patógeno identificado. Se observó en la vacuna una mayor tendencia a proteger contra casos de enfermedad con un promedio de seis o más deposiciones diarias. Estos resultados

Rejuvenecimiento facial en "doble sigma" "Double ogee" facial rejuvenation

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O. M. Ramírez

2007-03-01

Full Text Available Las técnicas subperiósticas descritas por Tessier revolucionaron el tratamiento del envejecimiento facial, recomendando esta vía para tratar los signos tempranos del envejecimiento en pacientes jóvenes y de mediana edad. Psillakis refinó la técnica y Ramírez describió un método más seguro y eficaz de lifting subperióstico, demostrando que la técnica subperióstica de rejuveneciento facial se puede aplicar en el amplio espectro del envejecimiento facial. La introducción del endoscopio en el tratamiento del envejecimiento facial ha abierto una nueva era en la Cirugía Estética. Hoy la disección subperióstica asistida endocópicamente del tercio superior, medio e inferior de la cara, proporciona un medio eficaz para la reposición de los tejidos blandos, con posibilidad de aumento del esqueleto óseo craneofacial, menor edema facial postoperatorio, mínima lesión de las ramas del nervio facial y mejor tratamiento de las mejillas. Este abordaje, desarrollado y refinado durante la última década, se conoce como "Ritidectomía en Doble Sigma". El Arco Veneciano en doble sigma, bien conocido en Arquitectura desde la antigüedad, se caracteriza por ser un trazo armónico de curva convexa y a continuación curva cóncava. Cuando se observa una cara joven, desde un ángulo oblicuo, presenta una distribución característica de los tejidos, previamente descrita para el tercio medio como un arco ojival arquitectónico o una curva en forma de "S". Sin embargo, en un examen más detallado de la cara joven, en la vista de tres cuartos, el perfil completo revela una "arco ojival doble" o una sigma "S" doble. Para ver este recíproco y multicurvilíneo trazo de la belleza, debemos ver la cara en posición oblicua y así poder ver ambos cantos mediales. En esta posición, la cara joven presenta una convexidad característica de la cola de la ceja que confluye en la concavidad de la pared orbitaria lateral formando así el primer arco (superior

Placebo Effect

Science.gov (United States)

... C. Spencer, MD Steven Karceski, MD The placebo effect Joseph H. Friedman, MD Richard Dubinsky, MD WHAT ... placebo: a “dummy” medication that should have no effect on the condition. Placebos are not only drugs. ...

Mapas temáticos de isolíneas de sequía Meteorológica para el municipio Florencia (Ciego de Ávila, Cuba)

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Yurisbel Gallardo Ballat; Oscar Brown Manrique; Lizander Martínez Santos

2015-01-01

Se presentan los resultados de un estudio desarrollado en el municipio Florencia de la provincia Ciego de Ávila en el período comprendido desde el año 1970 al 2010, a partir de la elaboración de mapas temáticos de isolíneas de sequías meteorológicas, con la utilización de 11 equipos pluviométricos distribuidos dentro del área de estudio y en zonas adyacentes. Se demuestra que es posible la elaboración de mapas de ocurrencia de sequías con la utilización del índice de Déficit de Precipitación ...

Vitamina D e cicatrização de pele: estudo prospectivo, duplo-cego, placebo controlado na cicatrização de úlceras de perna

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Claudine Juliana Cristina Caznoch Burkiewicz

Full Text Available OBJETIVO: Estudar a relação entre deficiência de vitamina D e cicatrização de pele em pacientes com úlceras de perna, relacionar esta deficiência com características da úlcera e avaliar se a reposição de vitamina D nos indivíduos deficientes acelera a cicatrização da úlcera. MÉTODOS: Foram escolhidos aleatoriamente 26 pacientes com úlceras venosas de perna e 26 sem úlcera pareados para sexo, idade, HAS e tabagismo. Os grupos foram comparados com relação à dosagem sérica de vitamina D. O grupo úlcera foi dividido em dois subgrupos: um que tomou placebo e outro que recebeu vitamina D 50.000UI por semana durante dois meses. Foi realizada a dosagem da 25-OH-vitamina D e avaliados o tamanho da úlcera e a gravidade da dor, antes e após o tratamento. RESULTADOS: A maioria dos pacientes apresentava níveis insuficientes de vitamina D. Não foi encontrada correlação entre o tamanho da úlcera sem tratamento e os níveis de vitamina D. Nos pacientes que receberam vitamina D, após o tratamento, o tamanho mediano da área da úlcera, diminui de 25cm², para 18cm² e no grupo placebo, de 27cm² para 24,5cm² (p=0,7051 e p=0,7877, respectivamente. Considerando-se a variabilidade da área da úlcera do grupo vitamina D versus placebo, a mediana foi igual a -0,75cm² no primeiro grupo e 4cm² no segundo grupo (p=0,0676. CONCLUSÃO: Pacientes com úlcera de perna têm mais deficiência de vitamina D que os sem. A deficiência de vitamina D não influiu nas características das lesões. A cicatrização nos pacientes com hipovitaminose D mostrou tendência para ser maior naqueles que receberam reposição vitamínica.

Compreendendo o Efeito Placebo / Understanding the Placebo Effect

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Elayne Vieira Dias

2015-12-01

Full Text Available Placebo é definido em termos farmacológicos como uma substância inerte, sem propriedades farmacológicas intrínsecas. No entanto, essa definição é superficial, visto que o placebo pode gerar efeitos terapêuticos que dependem de diversos fatores como palavras, rituais, símbolos e significados que acompanham seu uso. Assim, o efeito placebo não diz respeito apenas a uma substância, mas, envolve fatores cognitivos, genéticos e mecanismos de aprendizagem implícita e explícita. Nessa revisão nós abordamos os aspectos gerais do efeito placebo apoiados em diversos estudos com diferentes enfoques, visando uma melhor compreensão desse fenômeno que pode se somar ao tratamento ativo e otimizar os resultados na prática médica. Placebo is pharmacologically defined as an inert substance, with nointrinsic pharmacological properties. However, this is a superficial definition, since placebo may trigger therapeutic effects and its effectiveness depends on various factors such as words, rituals, symbols and meanings following its use. Thus, placebo effect does not refer just to the substance, but it also involves cognitive and genetic factors and learning mechanisms. Here, we review general aspects of the placebo effect supported by several studies with different approaches, to better understand this phenomenon which may contribute to active treatment as well as optimize the results in the clinical practice.

Sociedad de Estudios de Patología Quirúrgica de la Facultad de Medicina de Bogotá: estatutos: Estudio e Investigación. Reglamento: Tolerancia por las ideas ajenas (Acta de los días 4 y 11 de junio

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Roberto N. Ezpeleta H.

1932-11-01

Full Text Available El día 4 de junio a las 10 de la mañana se reunió la "Sociedad de Estudios de Patología Quirúrgica" en el salón de proyecciones adjunto al Laboratorio de Rayos X del Hospital. Presidió la sesión el Profesor Jorge E. Cavelier. Asistieron a ella los Profesores Corpas y Salgar, y los doctores Herrera Salgar y Jiménez. Suárez Una vez leída el acta de la sesión anterior, el doctor Herrera Salgar presentó un curioso caso sobre apéndice doble, dando una relación de él y mostrando unas placas anatomo-patológicas muy demostrativas. En seguida tomó la palabra el Profesor Corpas quien se refirió al caso presentado por el doctor Herrera Salgar, caso que, dijo, era tanto más interesante cuanto que se refería a una apendicitis crónica, pues muchas veces se presentaban falsos apéndices dobles. en las apendicitis agudas en las que el apéndice sufre a veces una especie de estrangulación cuya parte libre es injertada en el ciego semejando un apéndice doble. Dijo que el apéndice tenía por objeto suministrar una hormona cuyo papel es activar el peristaltismo intestinal, lo cual se puede comprobar por la constipación habitual de que son víctimas los apendicectomizados. Hizo referencias a las anomalías en la especie humana, como manifestaciones de evolución regresiva, y mostró cómo en el caso particular de apéndice doble éste estan frecuente en los hervíboros.

"Acreditamiento del impuesto por dividendos aplicables para evitar la doble tributación"

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Hernández Sosa, Cleopatra

2011-01-01

Este trabajo de investigación es el producto del estudio de las implicaciones dentro del Derecho Fiscal internacional de una materia que se base, sobre todas las cosas, en la necesidad que tenemos nosotros los países de América Latina, de buscar una verdadera y sólida integración económica y haciendose énfasis en un aspecto tan importante como lo es el Comercio Internacional,y aún más tratándose de un tema tan importante como la búsqueda de la eliminación de la DOBLE TRIBUTACIÓN INTERNACIONAL...

El soldado/poeta, el miedo, la derrota: una lectura de Segunda Derrota: 1940, de Los Girasoles Ciegos

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Magnólia Brasil Barbosa do Nascimento

2016-07-01

Full Text Available Se propone en este artículo una reflexión sobre los duros años de la inmediata posguerra civil española, privilegiando la “Segunda Derrota: 1940 o Manuscrito encontrado en el olvido”, uno de los cuentos de Los girasoles ciegos (2004, de Alberto Méndez (1941-2004, quien escribe para grabar la memoria del miedo vigente en aquel momento histórico. Por la importancia de la apropiación del pasado (Benjamin, se optó por acompañar las vicisitudes de un joven soldado/poeta que busca escapar hacia Francia con la novia embarazada y es sorprendido por la muerte de la joven durante el parto. En la obra, es fuerte el poder de la palabra (Agamben, 2008. El escritor tematiza la crueldad que interrumpió, de manera violenta, muchas vidas. En “Segunda Derrota”, se evidencia la importancia de la manutención de la memoria para que esas infames sombras no se pierdan en los silencios, y luego no caigan en el olvido.

Tratamento da disforia pré-menstrual com antidepressivos: revisão dos ensaios clínicos controlados Treatment of premenstrual dysphoria with antidepressants: review of controlled clinical trials

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Elie Cheniaux

2006-01-01

Full Text Available INTRODUÇÃO: A disforia pré-menstrual (DPM, que acomete entre 3% e 8% das mulheres em idade fértil, representa uma forma mais grave de síndrome pré-menstrual, na qual predominam as alterações do humor e do comportamento. Acredita-se que haja algum tipo de ligação entre a DPM e os transtornos do humor. OBJETIVO: Estudar a eficácia dos antidepressivos na DPM. MÉTODOS: Foi realizada uma revisão dos ensaios clínicos controlados com antidepressivos no tratamento da DPM, utilizando-se as seguintes bases de dados: Medline, Literatura Latino-Americana e do Caribe em Ciências da Saúde (LILACS, psycINFO e Biblioteca Cochrane. RESULTADOS: A clomipramina, a fluoxetina, a sertralina, a paroxetina e a venlafaxina se mostraram superiores ao placebo em diversos estudos. DISCUSSÃO: As mulheres que sofrem de DPM possivelmente apresentam uma disfunção serotoninérgica. CONCLUSÃO: Alguns antidepressivos, especialmente os inibidores seletivos da recaptação da serotonina (ISRS, parecem ser eficazes no tratamento da DPM.INTODUCTION: Premenstrual dysphoria (PMD, which affects between 3% and 8% of women during reproductive years, represents a more severe type of premenstrual syndrome. Mood and behavior changes are predominant in PMD. It is believed that there is some kind of link between PMS and mood disorders. OBJECTIVE: Studying the efficacy of antidepressants in PMD. METHODS: We elaborated a review of controlled clinical trials with antidepressants in the treatment of PMD, using the following databases: Medline, LILACS, psycINFO and Cochrane Library. RESULTS: Clomipramine, fluoxetine, sertraline, paroxetine and venlafaxine were superior to placebo in various studies. DISCUSSION: Women with PMD possibly present a serotonergic dysfunction. CONCLUSION: Some antidepressants, specialy SSRIs, seem to be effective in the treatment of PMD.

El conflicto interrol en parejas de doble ingreso identificación y comprensión de las relaciones trabajo-familia

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Infante Rejano, Eduardo

2000-01-01

Desde las perspectivas sistémicas, la tesis describe y explica las relaciones posibles entre el ámbito del trabajo y el ámbito de la familia. Introduce el concepto de pareja de doble ingreso/carrera y de conflicto trabajo-familia, mostrando los tipos y la

Review of the efficacy of placebo in comparative clinical trials between typical and atypical antipsychotics Revisão da eficácia do placebo nos ensaios clínicos que comparam antipsicóticos típicos e atípicos

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Irismar Reis de Oliveira

2009-03-01

esquizoafetivo, bem como avaliar a pertinência do uso do placebo nos ensaios clínicos com antipsicóticos. MÉTODO: Foram incluídos estudos nos quais os antipsicóticos atípicos foram comparados com antipsicóticos típicos e placebo simultaneamente. A pesquisa bibliográfica incluiu os termos "amisulprida", "aripiprazol", "clozapina", "olanzapina", "quetiapina", "risperidona", "sertindol", "ziprasidona" e "zotepina". Os principais parâmetros de eficácia foram a proporção de "eventos" (definidos como deterioração ou falta de melhora de pelo menos 20% na Positive and Negative Syndrome Scale ou Brief Psychiatric Rating Scale e os riscos relativos combinados (efeitos randômicos, com seus respectivos intervalos de confiança de 95%. Foram também estimados os tamanhos de amostras nos estudos em que a droga pesquisada fosse comparada com um antipsicótico típico ou com placebo. RESULTADOS: As taxas de eficácia combinada foram de 40,8%, 34,9% e 21,3%, respectivamente, para os antipsicóticos atípicos, antipsicóticos típicos e placebo. Cento e sessenta e seis pacientes teriam de ser incluídos quando a nova droga fosse comparada com placebo se os cálculos fossem baseados na diferença de 20% encontrada entre o antipsicótico atípico e placebo, ao passo que 2.054 teriam de ser incluídos se a diferença procurada fosse aquela encontrada entre o antipsicótico atípico e o antipsicótico típico, isto é, 6%. Os insucessos terapêuticos estimados seriam de 115 entre os 166 pacientes quando a droga em estudo fosse comparada com placebo, e de 1.274 entre os 2.054 pacientes quando fosse comparada com um antipsicótico típico. CONCLUSÕES: Os estudos controlados por placebo podem reduzir o número de indivíduos expostos aos efeitos prejudiciais de drogas ineficazes.

LA CONTABILIDAD Y LA PARTIDA DOBLE: REPERCUSIÓN EUROPEA DE LA OBRA MAESTRA DE LUCA PACIOLI (SIGLOS XVI-XVIII

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Miguel Gonçalves

2011-08-01

Full Text Available El artículo asume como finalidad la de analizar como se procesó la divulgación del método de la partida doble, con especial relevo para la literatura contabilística que en mucho ayudó a su difusión. De entre los diversos autores que contribuyeron para su generalización y difusión, se destaca Luca di Bartholomeu dei Pacioli. Por consiguiente, el artículo también tiene como objetivo presentar una reseña de los principales aspectos de la vida y de la obra de este tratadista de la Contabilidad, considerado por muchos el precursor de nuestra disciplina, por haber publicado en 1494 en Venecia la Summa de Arithmetica, Geometria, Proportioni et Proportionalita, obra primordial en el dominio de nuestra especialidad, más concretamente una sección suya – el Tratatus Particularis de Computis y Scripturis (De las Cuentas y las Escrituras. Palabras-clave: Historia de la Contabilidad. Partida Doble. Registros Contabilísticos. Luca Pacioli. De Computis et Scripturis.

A construção do controle por estímulos condicionais sobre o comportamento verbalmente controlado

OpenAIRE

Barrelin, Evelyn Christina Peres

2008-01-01

Insensibilidade tem sido referida como a persistência de um padrão de respostas a despeito da mudança nas contingências. Controle condicional sobre a contingência instrucional tem sido mencionado como uma das possíveis variáveis responsáveis por este desempenho, em contingências de reforçamento negativo. O presente trabalho teve como objetivo colocar o comportamento verbalmente controlado sob controle de estímulos e avaliar seu efeito sobre desempenhos posteriores, diante desses mesmos estímu...

Profilaxia antiemética em cirurgia de abdome agudo: estudo comparativo entre droperidol, metoclopramida, tropisetron, granisetron e dexametasona Profilaxis antiemética en cirugía de abdomen agudo: estudio comparativo entre droperidol, metoclopramida, tropisetrón, granisetrón y dexametasona Prophylactic antiemetic therapy for acute abdominal surgery: a comparative study of droperidol, metoclopramide, tropisetron, granisetron and dexamethasone

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Víctor Contreras-Domínguez

2008-02-01

Full Text Available JUSTIFICATIVA E OBJETIVOS: A incidência de náuseas e vômitos pós-operatórios (NVPO gira em torno de 30%. A profilaxia de NVPO foi objeto de múltiplos estudos, tanto para tentar diminuir esse problema como para comparar o índice custo-benefício do tratamento utilizado. Esse estudo comparou a eficácia de cinco fármacos antieméticos em apendicectomia. MÉTODO: Estudo clínico prospectivo controlado, duplamente encoberto de 150 pacientes ASA I e II com IMC JUSTIFICATIVA Y OBJETIVOS: La incidencia de náuseas y vómitos peri operatorios (NVPO se estima en un 30%. La profilaxis de NVPO ha sido objetivo de múltiples estudios, tanto para intentar disminuir este problema como a su vez comparar índice costo-beneficio de la terapia utilizada. Este estudio evalúa la utilización de 5 fármacos antieméticos en relación a grupo control para apendicectomía de urgencia. MÉTODO: Estudio clínico prospectivo controlado, doble ciego de 150 pacientes ASA I y II con IMC BACKGROUND AND OBJECTIVES: It is calculated that the incidence of postoperative nausea and vomiting (PONV is approximately 30%. The prophylaxis of PONV has been the subject of several studies, both to decrease this problem and to compare the cost-benefit ration of the treatment used. The objective of this study was to compare the efficacy of 5 antiemetic drugs with a control group in emergency appendectomy. METHODS: A controlled, double-blind, prospective study with 150 patients, ASA I and II, BMI < 30, undergoing appendectomy, was undertaken. Patients were divided in six groups: Group 1 (n = 25: 5 mL of normal saline; Group 2 (n = 25: 0.625 mg of droperidol; Group 3 (n = 25: 20 mg of metoclopramide; Group 4 (n = 25: 5 mg of tropisetron; Group 5 (n = 25: 1 mg of granisetron; Group 6 (n = 25: 4 mg of dexamethasone. Monitoring included ECG, non-invasive blood pressure, O2 saturation, P ET CO2, anesthetic gas analyzer and peripheral nerve stimulator. The presence of PONV, complications

INFLUENCIA DE LA BACTERIA Pseudomonas fluorescens EN LA LECHE, SOBRE LAS CARACTERÍSTICAS SENSORIALES DEL QUESO DOBLE CREMA

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SJ González

2007-01-01

Full Text Available El objetivo de este trabajo fue observar el efecto de la presencia de microorganismos psicro-tróÀcos en la leche, sobre las características sensoriales del queso doble crema. Para esto, se inoculó la leche con un cultivo de Pseudomonas Áuorescens, a un nivel de 108 unidades formadoras de colonia por mililitro (ufc/ml. La leche se refrigeró a 4 ºC por seis días, se pasteurizó y posteriormente se preparó el queso. Se elaboraron lotes de queso cada 10 días, con el Àn de obtener siete tiempos experimentales. A cada uno se le determinó la vida útil sensorial. Los resultados de las pruebas sensoriales se analizaron con el programa S-PLUS de estadísti-ca de supervivencia aplicada a la vida útil sensorial de alimentos. Se determinó que el tiempo de vida útil sensorial del queso doble crema elaborado con leche en estas condiciones, y alma-cenado a 4 °C, está alrededor de 30 días, disminuyendo en un 50% con relación al patrón.

Hypnosis, hypnotizability, and placebo.

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Frischholz, Edward J

2015-01-01

Dr. Raz's speculations about the relation between placebo responsivity and hypnotizability are critically examined. While there is no generally accepted theoretical definition of hypnosis, there is a general consensus that hypnotizability can be reliably measured. In contrast, there seems to be a general consensus about a theoretical definition of placebo (including placebo effect, placebo response, and nocebo). There is no widely accepted measure of individual differences in placebo responsivity. Various methodological considerations about how to examine the relation between placebo responsivity and hypnotizability are identified. Studies are identified which indicate that response to treatments which utilize adjunctive hypnosis are superior to placebo treatments. The only study which examined whether placebo responsivity was correlated with hypnotizability seems to indicate that they are only slightly related at best. The possibility that there may be such thing as a "good placebo responder (GPR)" is questioned, while the known clinical value of hypnotizability assessment is reaffirmed. Future directions for empirical research on the relation between placebo responsivity and hypnotizability are identified.

Hypnosis, hynotizability, and placebo.

Science.gov (United States)

Frischholz, Edward J

2007-07-01

Dr. Raz' speculations about the relation between placebo responsivity and hypnotizability are critically examined. While there is no generally accepted theoretical definition of hypnosis, there is a general consensus that hypnotizability can be reliably measured. In contrast, there seems to be a general consensus about a theoretical definition of placebo (including placebo effect, placebo response and nocebo). There is no widely accepted measure of individual differences in placebo responsivity. Various methodological considerations about how to examine the relation between placebo responsivity and hypnotizability are identified. Studies are identified which indicate that response to treatments which utilize adjunctive hypnosis are superior to placebo treatments. The only study which examined whether placebo responsivity was correlated with hypnotizability seems to indicate that they are only slightly related at best. The possibility that there may be such thing as a "good placebo responder (GPR)" is questioned, while the known clinical value of hypnotizability assessment is reaffirmed. Future directions for empirical research on the relation between placebo responsivity and hypnotizability are identified.

INFLUENCIA DEL AMAMANTAMIENTO CONTROLADO Y DEL EFECTO MACHO SOBRE EL RESTABLECIMIENTO DE LA ACTIVIDAD OVÁRICA POSPARTO EN LA OVEJA PELIBUEY

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Gladis Morales-Terán

2011-11-01

Full Text Available Se determinó el efecto del amamantamiento y del efecto macho sobre la duración del anestro posparto en ovejas Pelibuey y sobre el peso corporal de éstas y sus crías. Siete días después del parto 56 ovejas adultas y sus crías fueron asignadas al azar a los tratamientos: T1 Amamantamiento continuo (CS; n=14; T2 Amamantamiento controlado (RS; n=14; T3 Amamantamiento continuo con carnero (CSR; n=14; y T4 Amamantamiento controlado con carnero (RSR; n=14. Un carnero con mandil fue introducido con las ovejas del día 7 al 60 posparto por 30 min dos veces al día. El peso corporal de ovejas y corderos se registró semanalmente del parto al destete. El porcentaje de ovulación en los primeros 60 días posparto fue mayor en RSR (100 %; P ≤ 0.05 que en RS, CSR y CS (57.1, 64.8 y 35.7 %, respectivamente. El control del amamantamiento redujo (P ≤ 0.05 el intervalo parto-primera ovulación (ILFO en RSR (42.07±2.8 días con respecto a RS, CSR y CS (51.07±3.24, 50.50±3.26 y 56.71±1.73 días, respectivamente. No hubo diferencias (P > 0.05 en peso corporal de ovejas y corderos. La interacción amamantamiento controlado-efecto macho aumentó el porcentaje de ovulación antes del día 60 posparto y redujo el ILFO, sin afectar el peso corporal de ovejas y corderos.

FRECUENCIAS ALELICAS Y GENOTIPICAS DEL GEN KAPPA CASEINA EN BOVINOS DE DOBLE PROPOSITO

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Nohémi Gabriela Cortes López

2012-01-01

Full Text Available En este trabajo, las frecuencias alélicas (A y B del gen CAS se determinaron como criterio de selección en la calidad de la leche en el ganado bovino de doble propósito. Se tomaron muestras sanguíneas de 200 hembras bovinas y se colocaron en tubos que contenían EDTA. Se amplifico el marcador MB002 a partir de material genético extraído. Los RFLP se realizaron con la enzima de restricción Hinf I para el diagnóstico de los alelos A y B en CASκ. Las frecuencias genotípicas obtenidas correspondían a 0.34, 0.01 y 0.65 para los alelos AA, BB y AB, respectivamente. Las frecuencias alélicas fueron de 0.67 y 0.33 para los alelos A y B, respectivamente. Además, se registró una heterocigosidad promedio de 0.6481. La población es estudio no se encuentra en equilibrio Hardy Weinberg, el valor ji cuadrada fue de 2 = 14.8 con 2 grados de libertad (P < 0.005. Basado en la frecuencia alélica de CAS  B (0.34 observada en este estudio, el ganado de doble propósito puede ser una opción viable para aumentar la calidad de la leche si se utilizan sementales con el genotipo BB para el cruce. De esta manera, los alelos B asociados a la calidad de la leche pueden mejorarse en pocas generaciones.

Adjunctive micronutrient supplementation for pulmonary tuberculosis Suplementación con micronutrientes como tratamiento adjunto para tuberculosis pulmonar

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Rodrigo X Armijos

2010-06-01

Full Text Available OBJECTIVE: To assess the effect of micronutrient supplementation on tuberculosis (TB patient outcomes. MATERIAL AND METHODS: The randomized, double-blinded, placebo-controlled study was conducted in pulmonary TB patients undergoing directly observed treatment short course/ tratamiento acortado estrictamente supervisado (TAES/ DOTS at IMSS in Ciudad Juarez, Chihuahua, Mexico, who were recruited during August 2005-July 2006. Consecutive patients received zinc and vitamin A supplements or matched placebo for four months. Dietary intake, blood zinc and vitamin A, immune response (IFN-γ,TNF-α, and IL-10 mRNA, and sputum smear conversion were measured. RESULTS: The proportion of micronutrient compared to placebo group subjects with a negative sputum smear by month 3 was significantly increased (p= 0.03. This occurred subsequent to increased TNF-α and IFN-γ and decreased IL-'0 observed at month 2. Micronutrient supplementation appeared to accelerate the beneficial therapeutic effect of chemotherapy. CONCLUSIONS: The earlier elimination of bacilli from sputum was associated with improved zinc status and Th' immune response. The therapeutic effect of vitamin A was less evident.OBJETIVO: Determinar el efecto de la suplementación con zinc y vitamina A o placebo en pacientes tratados por tuberculosis (TB. MATERIAL Y MÉTODOS: Se realizó un ensayo aleatorizado en pacientes tuberculosos que iniciaron el tratamiento acortado estrictamente supervisado/ directly observed treatment short course (TAES/DOTS en las clínicas del IMSS, Ciudad Juárez, Chihuahua, México, reclutados durante agosto 2005-julio 2006. A cada paciente en forma aleatoria se le designó un código para recibir ya sea micronutrientes o placebo por cuatro meses, bajo el diseño doble ciego. Se evaluó la ingesta dietética, niveles de zinc y vitamina A en sangre, respuesta inmune (IFN-γ,TNF-α, IL-l0 mRNA en sangre y bacilo ácido alcohol resistente (BAAR en esputo. RESULTADOS: Al

Tecnologia tátil para a avaliação da dor em cegos Tecnología táctil para la evaluación del dolor en ciegos Tactile technology for pain evaluation in blind people

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Ana Cláudia de Souza Toniolli

2003-03-01

Full Text Available Trata-se de um estudo descritivo e exploratório das percepções dos cegos acerca do protótipo chamado Escala Tátil, para avaliação da intensidade da dor. Por meio de uma entrevista semi-estruturada, foram obtidos os relatos de cegos da Associação dos Cegos do Ceará, para descrever a natureza do protótipo, estabelecendo relações entre as suas experiências dolorosas e buscando significados para a sua utilização na cultura dos cegos. Dos relatos, foram identificados e analisados três temas: intensidade da dor na ponta dos dedos, percepção da escala tátil da dor, destacando-se textura, forma e tamanho, lapidando-se a Escala Tátil. A percepção sensorial tátil dos cegos gerou novos parâmetros de reflexão para o estudo da dor e direcionou a performance do protótipo para um processo de comunicação da dor mais satisfatório.Este es un estudio descriptivo de las percepciones de los ciegos acerca del prototipo llamado Escala Táctil para evaluación de la intensidad del dolor. A través de una entrevista semi-estructurada, se obtuvieron relatos de ciegos de la Asociación del Ciegos de la ciudad de Ceará-BR para describir la naturaleza del prototipo, estableciendo relaciones entre sus experiencias dolorosas y buscando significados para su utilización en la cultura de los ciegos. De los relatos fueron identificados y analizados tres temas: intensidad del dolor en la punta de los dedos, percepción de la escala táctil del dolor: textura, forma y tamaño y puliendo la Escala Táctil. La percepción sensorial de las personas ciegas generó nuevos parámetros de reflexión para el estudio del dolor y orientó la performance del prototipo hacia un proceso de comunicación del dolor más satisfactorio.This is a descriptive study of blind people perceptions about a prototype called Tactile Scale for pain intensity evaluation. By means of a half-structured interview, reports were collected from blind people from the Ceará Blind

Treinamento auditivo acusticamente controlado em um indivíduo adulto após traumatismo cranioencefálico

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Andrea Tortosa Marangoni Castan

Full Text Available RESUMO A avaliação eletrofisiológica e comportamental do processamento auditivo tem sido uma importante ferramenta para o diagnóstico e monitoramento terapêutico de indivíduos pós traumatismo cranioencefálico. No presente relato de caso o paciente foi submetido à avaliação eletrofisiológica e comportamental do processamento auditivo pré e pós treinamento auditivo acusticamente controlado (TAAC e seis meses após a intervenção. O TAAC foi organizado em oito sessões, enfocando o treinamento das habilidades auditivas de ordenação temporal, fechamento auditivo e figura-fundo. Na avaliação pós TAAC foi observada melhora quanto aos processos gnósicos de codificação, organização e não verbal. Em relação à avaliação eletrofisiológica houve melhora na morfologia e na latência das ondas do potencial evocado auditivo de tronco encefálico e na amplitude do componente potencial evocado auditivo de longa latência (P300. Na reavaliação após 6 meses do TACC foi verificada estabilidade e melhora da avaliação comportamental e eletrofisiológica. O treinamento auditivo acusticamente controlado mostrou-se eficaz ao desenvolver e refinar diferentes habilidades auditivas como demonstrado na avaliação eletrofisiológica e comportamental do processamento auditivo e os benefícios mostraram-se estáveis no longo prazo.

Las relaciones causales recíprocas del binomio Partida Doble-desarrollo de Occidente: La Teneduría de Libros de los mercaderes medievales

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Juan Lanero Fernández

2010-06-01

Full Text Available Mucho se ha escrito sobre la aportación de la Partida Doble al desarrollo económico de Occidente. El presente trabajo pretende presentar un análisis detallado del papel que desempeñó la contabilidad en la génesis del capitalismo. La contabilidad, como herramienta de gestión, fue un factor clave en la organización comercial.Después de ofrecer una visión panorámica de la organización del comercio en la época medieval y de considerar varias acepciones del concepto de partida doble, el estudio concluye que ésta fue al mismo tiempo causa y efecto de la transición de los mercaderes itinerantes a sedentarios.La expansión del comercio y del número de inversiones en las que un mercader podía estar inmerso a un mismo tiempo creó la necesidad de una integración y un ordenamiento que, en cierto modo, la Partida Doble exigía y propagaba. Un comercio más amplio demandaba un sistema gerencial mejor. Ese buen sistema gerencial –la partida doble-, fue un factor decisivo en el incremento comercial.Thousands of pages have been written about the double-entry contribution to the economic development of the Western world. The present paper tries to present a detailed analysis on the role played by Accounting in the genesis of capitalism. Accounting, as a management tool, was a key factor in the commercial organization.After having offered a general view about the organization of commerce in the Medieval era, some double-entry concepts are dealt with. The study concludes that double-entry was at the same time cause and effect of the transition from travelling merchants to resident ones.The expansion of commerce and the number of investments a merchant could be involved in at a time created the need of an integration and an order that, to certain extent, double-entry implied and spread. A bigger commerce demanded a better management system. This managerial system –the double-entry-, was a conclusive factor in the commercial growth.

Single-dose systemic methotrexate vs expectant management for treatment of tubal ectopic pregnancy: a placebo-controlled randomized trial.

Science.gov (United States)

Jurkovic, D; Memtsa, M; Sawyer, E; Donaldson, A N A; Jamil, A; Schramm, K; Sana, Y; Otify, M; Farahani, L; Nunes, N; Ambler, G; Ross, J A

2017-02-01

subgroup of women with higher β-hCG. In women with successful conservative treatment, there was no significant difference in median β-hCG resolution times between study arms (17.5 (interquartile range (IQR), 14-28.0) days (n = 30) in the methotrexate group vs 14 (IQR, 7-29.5) days (n = 25) in the placebo group; P = 0.73). The results of our study do not support the routine use of methotrexate for the treatment of clinically stable women diagnosed with tubal ectopic pregnancy presenting with low serum β-hCG (women with tubal ectopic pregnancy and β-hCG ≥ 1500 IU/L in whom methotrexate may offer a safe and cost-effective alternative to surgery. Copyright © 2016 ISUOG. Published by John Wiley & Sons Ltd. Comparación entre una sola dosis de metotrexate sistémico y la conducta expectante en el tratamiento de casos de embarazo ectópico tubárico: un ensayo aleatorio controlado con placebo RESUMEN OBJETIVO: El metotrexate se utiliza de modo rutinario en todo el mundo para el tratamiento de las mujeres clínicamente estables con un embarazo ectópico tubárico. Esto sucede a pesar de la falta de evidencia rigurosa que demuestre que su eficacia es superior a la conducta expectante. El objetivo de este ensayo controlado aleatorio multicéntrico fue comparar las tasas de éxito del metotrexate con las de un placebo para el tratamiento cauteloso del embarazo ectópico tubárico. MÉTODOS: Este estudio se llevó a cabo en dos clínicas de control de gestación temprana en el Reino Unido entre agosto de 2005 y junio de 2014. Los criterios de inclusión fueron mujeres clínicamente estables con un diagnóstico ecográfico concluyente de embarazo ectópico tubárico, las cuáles presentaban una concentración sérica baja de la β hormona coriónica gonadotrópica (β-hCG) inferior a 1500 UI/L. Las mujeres fueron asignadas aleatoriamente a una sola inyección sistémica de 50 mg/m2 de metotrexate o a placebo. El resultado primario fue un indicador binario del �

Diclofenaco intramuscular no tratamento agudo da migrânea: um estudo duplo cego placebo controlado Intramuscular diclofenac in the acute treatment of migraine: a double-blind placebo controlled study

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Marcelo E. Bigal

2002-06-01

Full Text Available O objetivo do presente estudo é avaliar, com mascaramento duplo, o efeito do diclofenaco sobre a dor e sintomas associados em pacientes com crise de migrânea. Sessenta pacientes com migrânea com aura e sessenta pacientes com migrânea sem aura foram randomizados para receber diclofenaco intramuscular, na dose de 75 mg, associado com injeção intravenosa de solução salina, 10 ml, ou para receber solução salina isoladamente. Três parâmetros de avaliação analgésica e uma escala analógica para avaliar os sintomas associados foram usados. Aferimos ainda os percentuais de recorrência e de utilização de medicação de resgate. Pacientes que receberam diclofenaco apresentaram redução na intensidade da dor estatisticamente significativa, 60 minutos após a administração, em dois dos três parâmetros utilizados (migrânea sem aura e nos três parâmetros utilizados (migrânea com aura. Não observamos diferença, comparado com o placebo, na intensidade dos sintomas associados. Houve redução da recorrência e da utilização de medicação de resgate. A despeito de ser uma opção no tratamento das migrâneas em unidades de emergência, o diclofenaco apresenta início de ação lento e nenhum efeito nos sintomas associados.The aim of this study is to assess, in a double blind fashion, the effect of diclofenac on the pain and associated symptoms in patients with acute migraine. 60 patients with migraine with aura and 60 patients with migraine without aura were assigned at random to receiving intramuscular diclofenac, 75 mg associated to intravenous physiological saline, 10 ml, or physiological saline alone. We used 3 parameters of analgesic evaluation and an analogical scale to asses associated symptoms. We also observed the recurrence and rescue medication percentiles. Patients receiving diclofenac showed a statistically significant improvement of pain 60 minutes after the administration in two of the three parameters

[Placebo effect in Parkinson's disease].

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Miwa, Hideto

2007-02-01

"Placebo" is Latin for "I shall please". The placebo effect has been widely documented by randomized placebo-controlled drug studies. One of the best examples of placebo effectiveness is that have been shown in clinical trials of anti-parkinsonian drugs. The placebo effect is observable not only in drug trials but also with deep brain stimulation. Recent advances in research on the placebo effect in Parkinson's disease (PD) have suggested that motor symptoms of PD can be essentially improved by placebo. A recent study using positron emission tomography (PET) with raclopride demonstrated that release of endogeneous dopamine in the dorsal striatum occurs in placebo-responsive patients with PD. This suggests that placebo-induced expectation of clinical improvement may activate endogenous dopamine in the striatum, and that placebo effectiveness is thus achieved by endogenous dopamine supplementation. Indeed, decreased neuronal activities in the subthalamic nucleus (STN), that were recorded during surgery to implant deep brain stimulation electrodes, correlated well with placebo-induced clinical improvement in patients with PD. Although the detailed pathophysiological mechanism underlying the placebo effects remains uncertain, theoretically, the placebo effect has generally been explained by two different mechanisms: one is conditioning theory (pavlovian conditioning), and the other is cognitive theory (expectation of clinical improvement). Although both mechanisms may contribute to placebo effects, the placebo effect in PD may be attributed more to cognitive mechanisms such as expectation of improvement, because the placebo effect can be obtained in de novo PD patients. There have been accumulating findings that suggest a functional relationship between dopamine and the expectation of clinical improvement (reward). Further basic studies are required to clarify the complex link between dopamine and the reward system, but such findings will contribute to a better

Placebo-induced somatic sensations: a multi-modal study of three different placebo interventions.

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Florian Beissner

Full Text Available Somatic sensations induced by placebos are a frequent phenomenon whose etiology and clinical relevance remains unknown. In this study, we have evaluated the quantitative, qualitative, spatial, and temporal characteristics of placebo-induced somatic sensations in response to three different placebo interventions: (1 placebo irritant solution, (2 placebo laser stimulation, and (3 imagined laser stimulation. The quality and intensity of evoked sensations were assessed using the McGill pain questionnaire and visual analogue scales (VAS, while subjects' sensation drawings processed by a geographic information system (GIS were used to measure their spatial characteristics. We found that all three interventions are capable of producing robust sensations most frequently described as "tingling" and "warm" that can reach consider-able spatial extent (≤ 205 mm² and intensity (≤ 80/100 VAS. Sensations from placebo stimulation were often referred to areas remote from the stimulation site and exhibit considerable similarity with referred pain. Interestingly, there was considerable similarity of qualitative features as well as spatial patterns across subjects and placebos. However, placebo laser stimulation elicited significantly stronger and more widespread sensations than placebo irritant solution. Finally, novelty seeking, a character trait assessed by the Temperament and Character Inventory and associated with basal dopaminergic activity, was less pronounced in subjects susceptible to report placebo-induced sensations. Our study has shown that placebo-induced sensations are frequent and can reach considerable intensity and extent. As multiple somatosensory subsystems are involved despite the lack of peripheral stimulus, we propose a central etiology for this phenomenon.

Tratamento do câncer de esôfago: ensaio clinico controlado

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Antonio Pedro Mirra

Full Text Available Realização de ensaio clínico controlado em câncer de esôfago, com uma casuística de 65 casos, no Hospital A.C. Camargo, no período de 1986 a 1990. O ensaio clínico controlado estudou três grupos terapêuticos: grupo I - cirurgia exclusiva (20 casos; grupo 2 - cirurgia + radioterapia pós-operatória (27 casos; grupo 3 - quimioterapia pré-operatória + cirurgia + radioterapia e quimioterapia pós-operatória (18 casos. O tempo cirúrgico foi único, com ressecção ampla do esôfago, utilizando-se como vias de acesso, preferentemente, a transpleural para os tumores localizados no terço médio do esôfago e a transmediastinal para o terço inferior e segmento abdominal. A retirada dos gânglios linfáticos regionais fez parte deste tempo cirúrgico, bem como a técnica de plastia padronizada com o estômago, com anastomose extratorácica cervical e posição do estômago no mediastino posterior. A radioterapia foi aplicada no leito esofágico, com dose total de 4.500 a 5.000 cGY em cinco sessões semanais. Foram utilizadas as drogas cisplatina (80 mg/m², vincristina (1,5 mg/m² e bleomicina (10mg/m² na quimioterapia pré e pós-operatórias. A sobrevida de cinco anos, segundo os grupos terapêuticos, foi de: grupo I - 61,9% , grupo 2 - 52,6 % e grupo 3 - 68,7%. Esta sobrevida, segundo o estadiamento clínico, foi de: EC I+II A - 52,0% e EC II B + III- 45,5%. Esses resultados estatisticamente não foram significativos. Os índices de sobrevida de cinco anos para os grupos terapêuticos 1 e 2 variaram de 40,4 a 60,6% quando os EC foram I + II A; para os demais EC não houve sobrevida de cinco anos. Para uma melhor avaliação, a inclusão de maior número de casos em pesquisas desse tipo poderia ser obtida pela participação de vários centros de tratamento do câncer de esôfago.

“Veo a los humanos como a árboles”: aproximación exegética al relato de curación del Ciego de Betsaida (Mc 8:22-26

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Juan Alberto Casas Ramírez

2017-01-01

Full Text Available Este artículo propone un análisis exegético del relato bíblico de la curación del ciego de Betsaida (Mc 8:22-26 a partir del desarrollo de tres aproximaciones sucesivas, interdependientes y acumulativas. En primer lugar se aborda la perícopa mediante la presentación de la versión griega, su estructura narrativa y su traducción, de corte literal. En segundo lugar se abordan los contextos narrativos del texto desde su marco literario y narrativo. Finalmente, se analiza cada una de las escenas del relato tratando de dilucidar su sentido simbólico.

The Effect of the Type and Colour of Placebo Stimuli on Placebo Effects Induced by Observational Learning

Science.gov (United States)

Świder, Karolina; Bąbel, Przemysław

2016-01-01

Research shows that placebo analgesia and nocebo hyperalgesia can be induced through observational learning. Our aim was to replicate and extend these results by studying the influence of the type and colour of stimuli used as placebos on the placebo effects induced by observational learning. Three experimental and two control groups were tested. All participants received pain stimuli of the same intensity preceded by colour lights (green and red) or geometric shapes (circles and squares). Before receiving pain stimuli, participants in the experimental groups, but not in the control groups, observed a model who rated pain stimuli that were preceded by either green lights (green placebo group), red lights (red placebo group), or circles (circle placebo group) as being less painful than those preceded by either red lights (green placebo group), green lights (red placebo group), or squares (circle placebo group). As a result participants in the experimental groups rated pain stimuli preceded by either green lights (green placebo group), red lights (red placebo group), or circles (circle placebo group) as being less painful than the participants in the control groups did, indicating that placebo effect was induced. No statistically significant differences were found in the magnitudes of the placebo effects between the three experimental groups (green placebo, red placebo, and circle placebo groups), indicating that neither the type nor the colour of placebo stimuli affected the placebo effects induced by observational learning. The placebo effects induced by observational learning were found to be unrelated to the individual differences in pain anxiety, fear of pain, and empathy. PMID:27362552

Placebo and nocebo

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Luana Colloca

2009-06-01

Full Text Available Over the past two decades the placebo and nocebo effect has shifted from being a nuisance in clinical research to a promising model of an emerging neuroscience of mind-brain-body interactions. In fact, the interest in and the success of placebo research resides in its multifaceted meaning, which involves key issues in modern science - from neurobiology to philosophy, from ethics to social psychology, and from clinical trials design to medical practice. Thus, the placebo effect, which has long been neglected by the neuroscience community, is today considered a real and detectable biological phenomenon, and the question of whether placebos work has been reframed as to how they work. The aim of this review is to introduce the reader to the nature and extent of the placebo and nocebo phenomenon and to present the interesting implications of the new evidence that arises from recent research in the field of pain.

Infusão de insulina em terapia intensiva: ensaio controlado randomizado

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Milena Penteado Ferraro Miranda

2013-06-01

Full Text Available Ensaio clínico controlado e aleatorizado que comparou o uso de protocolo de insulina intensivo e convencional na evolução clínica de pacientes em sepse grave e choque séptico, nas primeiras 72 h. Foi conduzido em um hospital universitário na cidade de São Paulo. Os pacientes (n=46 foram alocados em dois grupos: glicêmico intensivo (glicemia entre 80-110mg/dl e convencional (180-220mg/dl. Utilizaram-se testes t-Student e Qui-Quadrado na análise dos dados. Observou-se diferença estatisticamente significativa (p<0,001 na média glicêmica, mas não houve diferença para as variáveis pressão arterial média mínima (p=0,06 e máxima (p=0,11, creatinina sérica (p=0,33 e na mortalidade (p=0,11. Apesar de não haver diferença entre os grupos quanto à mortalidade, a instabilidade hemodinâmica no grupo convencional foi mais duradoura e somente nele ocorreram óbitos.

Placebo - More hatred than love

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Hong-Liang Zhang

2011-01-01

Full Text Available A placebo is a sham medical intervention that can produce a placebo effect. Laboratory evidence supports the existence of several mechanisms of placebo effects in both healthy population and patients with a variety of medical conditions. The ethics of placebos have long been debated. However, accumulating ethical concern has arisen from the worldwide use of placebo in randomized control trials (RCTs, which may render their participants without early and optimal treatment. Although the pilgrimage of placebo is still on the way, refinement of controls in RCTs is worth paying new attention to.

Placebo - More hatred than love.

Science.gov (United States)

Zhang, Hong-Liang

2011-01-01

A placebo is a sham medical intervention that can produce a placebo effect. Laboratory evidence supports the existence of several mechanisms of placebo effects in both healthy population and patients with a variety of medical conditions. The ethics of placebos have long been debated. However, accumulating ethical concern has arisen from the worldwide use of placebo in randomized control trials (RCTs), which may render their participants without early and optimal treatment. Although the pilgrimage of placebo is still on the way, refinement of controls in RCTs is worth paying new attention to.

LA RELACIÓN ENTRE TRATADOS DE INVERSIÓN Y CONVENIOS DE DOBLE TRIBUTACIÓN: el caso chileno

OpenAIRE

Lazo, Rodrigo Polanco; Villanueva, Felipe Yáñez

2016-01-01

El presente artículo examina las relaciones entre los tratados de inversión y los tratados de doble tributación, considerando que, en la actual evolución de ambos tipos de acuerdos, sus disposiciones pueden presentar superposiciones en aspectos tales como estándares de protección, transparencia, trato nacional, cláusula de la nación más favorecida, expropiación y transferencias de capital. Tomando el ejemplo de los tratados suscritos por Chile, en este trabajo se examinan las consecuencias de...

Placebo can enhance creativity.

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Liron Rozenkrantz

Full Text Available The placebo effect is usually studied in clinical settings for decreasing negative symptoms such as pain, depression and anxiety. There is interest in exploring the placebo effect also outside the clinic, for enhancing positive aspects of performance or cognition. Several studies indicate that placebo can enhance cognitive abilities including memory, implicit learning and general knowledge. Here, we ask whether placebo can enhance creativity, an important aspect of human cognition.Subjects were randomly assigned to a control group who smelled and rated an odorant (n = 45, and a placebo group who were treated identically but were also told that the odorant increases creativity and reduces inhibitions (n = 45. Subjects completed a recently developed automated test for creativity, the creative foraging game (CFG, and a randomly chosen subset (n = 57 also completed two manual standardized creativity tests, the alternate uses test (AUT and the Torrance test (TTCT. In all three tests, participants were asked to create as many original solutions and were scored for originality, flexibility and fluency.The placebo group showed higher originality than the control group both in the CFG (p<0.04, effect size = 0.5 and in the AUT (p<0.05, effect size = 0.4, but not in the Torrance test. The placebo group also found more shapes outside of the standard categories found by a set of 100 CFG players in a previous study, a feature termed out-of-the-boxness (p<0.01, effect size = 0.6.The findings indicate that placebo can enhance the originality aspect of creativity. This strengthens the view that placebo can be used not only to reduce negative clinical symptoms, but also to enhance positive aspects of cognition. Furthermore, we find that the impact of placebo on creativity can be tested by CFG, which can quantify multiple aspects of creative search without need for manual coding. This approach opens the way to explore the behavioral and neural mechanisms by which

Placebo can enhance creativity.

Science.gov (United States)

Rozenkrantz, Liron; Mayo, Avraham E; Ilan, Tomer; Hart, Yuval; Noy, Lior; Alon, Uri

2017-01-01

The placebo effect is usually studied in clinical settings for decreasing negative symptoms such as pain, depression and anxiety. There is interest in exploring the placebo effect also outside the clinic, for enhancing positive aspects of performance or cognition. Several studies indicate that placebo can enhance cognitive abilities including memory, implicit learning and general knowledge. Here, we ask whether placebo can enhance creativity, an important aspect of human cognition. Subjects were randomly assigned to a control group who smelled and rated an odorant (n = 45), and a placebo group who were treated identically but were also told that the odorant increases creativity and reduces inhibitions (n = 45). Subjects completed a recently developed automated test for creativity, the creative foraging game (CFG), and a randomly chosen subset (n = 57) also completed two manual standardized creativity tests, the alternate uses test (AUT) and the Torrance test (TTCT). In all three tests, participants were asked to create as many original solutions and were scored for originality, flexibility and fluency. The placebo group showed higher originality than the control group both in the CFG (pcreativity. This strengthens the view that placebo can be used not only to reduce negative clinical symptoms, but also to enhance positive aspects of cognition. Furthermore, we find that the impact of placebo on creativity can be tested by CFG, which can quantify multiple aspects of creative search without need for manual coding. This approach opens the way to explore the behavioral and neural mechanisms by which placebo might amplify creativity.

LOS LIBROS MANUAL Y MAYOR DE LA CAJA DE LA SACRISTÍA DE LA CATEDRAL DE VALENCIA: UNA ADAPTACIÓN DE LA PARTIDA DOBLE (1546-1555

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Inmaculada Llibrer Escrig

2016-07-01

Full Text Available Este trabajo analiza dos libros de cuentas: un manual y un mayor, empleados para registrar las transacciones del efectivo depositado en la caja fuerte de la Catedral de Valencia. Siguiendo a de Roover, la mera existencia de los libros manual y mayor no es suficiente para afirmar su pertenencia a la partida doble, por lo que fue necesario revisar todos los elementos característicos de este método y compararlos con los que se encontraban en estos libros. También, se fijó como objetivo conocer los motivos que determinaron el modo de registro empleado, pretendiendo conocer la naturaleza de la información que este sistema aportaba y por qué no se respetaron algunas reglas de la partida doble. El sistema contable aprovechó las ventajas del método contable introduciendo varias innovaciones como: los asientos de ajuste sólo en el libro mayor, un doble asiento de apertura y la incorporación, previa a la apertura, del detalle de todas las transacciones que, consecuencia de los ajustes en los libros anteriores, conducían al saldo de apertura. El estudio permite inferir la concepción económica que el cabildo tenía de su organización y el rol que el sistema contable jugó dentro de la organización dado que la información era de carácter interno y confidencial.

334. Strategies for the optimization of antithrombotic therapy and reduction events after coronary artery bypass graft surgery: stop events cabg trial

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M. Carnero Alcázar

2012-04-01

Métodos: Se ha diseñado un estudio prospectivo, aleatorizado, doble ciego y multicéntrico. Se incluirán pacientes sometidos a CRC que reciban injertos venosos. Se aleatorizarán los sujetos en dos grupos: antiagregación con ácido acetilsalicílico (AAS o AAS + prasugrel (inicio en primeras 24 h postoperatorias. Se registrarán los eventos hemorrágicos, y se medirá la permeabilidad de los injertos mediante tomografía computarizada (TC multicorte a los 3 meses. Otros eventos: muerte, accidente cerebrovascular (ACV, infarto, reintervención coronaria, fallo del injerto previo a los 3 meses. Estudio bilateral, riesgo α: 0,05, potencia (1-ß: 80%. Diferencia a detectar: 6%. Pérdidas estimadas: 15%. Número de injertos por brazo: 490. Número de pacientes por brazo: 250. Análisis intermedio con 150 sujetos en cada brazo.

Restauración de la casa doble de Le Corbusier en la Weissenhofsiedlung

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Arne Fentzloff

2014-07-01

Full Text Available La Casa Doble diseñada por Le Corbusier en 1927 para la Weissenhofsiedlung constituye un hito en el diseño y construcción de viviendas en el Movimiento Moderno. Su precario estado de conservación requería una restauración que la Fundación Wüstenrot ha acometido con la voluntad no de repristinar necesariamente a su condición originaria, sino de restaurar el conjunto y habilitarlo para la visita pública conservando al menos parcialmente las diversas reformas y adaptaciones de uso que había sufrido estas viviendas pareadas durante sus años de historia. El texto explica abundantes detalles constructivos de su proceso de diseño y construcción y revela las soluciones técnicas adoptadas durante la restauración.

Transformación de lenguaje natural a controlado en la educción de requisitos: una síntesis conceptual basada en esquemas preconceptuales

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Bell Manrique Losada

2014-01-01

Full Text Available La educción de requisitos implica la identificación, captura e integración de requisitos, bajo la intervención de un grupo de analistas e interesados, generando descripciones textuales o gráficas que plasman los conceptos más relevantes del dominio del interesado, para el desarrollo de una aplicación de software. Tradicionalmente, las etapas de identificación y obtención de requisitos (que se expresan en lenguaje natural se ejecutan a partir de técnicas que requieren alta intervención del analista y amplio conocimiento del contexto/dominio del problema. Lo anterior implica un proceso subjetivo, ambiguo, con errores, que ocasiona pérdidas en la generación de modelos iniciales del dominio (especificados en un lenguaje controlado. En este artículo se realiza una síntesis de los acercamientos conceptuales y tendencias encontrados en la literatura referentes a la transformación de lenguaje natural a lenguaje controlado en la educción de requisitos. Finalmente, se propone un esquema pre-conceptual que representa el marco conceptual del proceso de transformación.

Impactos provocados por la sequía agrícola en el cultivo de Plátano (Musa) en áreas del municipio Venezuela, Ciego de Ávila, Cuba

OpenAIRE

Yurisbel Gallardo Ballat; Oscar Brown Manrique; Patricio W. Williams Harriot; Yiliane Matamoros Martinez; Isanary Rodríguez Carbajal

2017-01-01

En la presente investigación se realiza el análisis del impacto provocado por la sequía agrícola en el cultivo del Plátano Vianda (Musa paradisiaca) en un período de 13 años en áreas de municipio de Venezuela de la provincia de Ciego de Ávila. Cuba, para el análisis de los períodos de sequía se utilizó el Índice de Sequía Agraria (ISA) el cual presenta dentro de su algoritmo matemático como variables determinantes la Evapotranspiración de Referencia, que en este caso se determinó con el métod...

Nothingness and the placebo effect phenomenon

DEFF Research Database (Denmark)

Jensen, Tine

The placebo effect is a pharmacological conundrum, since it is a medical effect that is produced by “nothing” because no pharmacologically active substance is present in placebo. Placebo has, among other things, been defined as an inert substance, often a calcium pill. Simultaneously it presents...... a posthuman angle, applying Karen Barad’s concept of agential realism to tackle the issue of nothingness. I argue that the placebo effect produces specific agencies in the placebo effect phenomenon – that is, both the subject under treatment and the placebo emerge in the placebo effect in the act of measuring it...

Mejoramiento de la eficiencia de una extrusora de doble tornillo para fabricación de tubería

OpenAIRE

Suescum, Juan A.; Rigail, Andres

2009-01-01

El rendimiento de las máquinas en una industria es de gran importancia en el momento de determinar los costos del producto elaborado. En este trabajo se enfocó la optimización en el uso de una extrusora de doble tornillo con la finalidad de disminuir los gastos generados por desechos y fallas de calidad. Para esto, se describió el proceso de extrusión, considerando la composición del compuesto, el diseño del molde y de los calibradores. Conociendo el proceso se logró identificar sus limita...

Expectativas en la cirugía de triple procedimiento versus doble procedimiento quirúrgico en afecciones corneales Expectations of triple procedure versus double procedure surgery in corneal diseases

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Emilio Kuri Cienfuegos

2007-12-01

Full Text Available Se realizó un estudio retrospectivo y descriptivo con el propósito de evaluar el comportamiento de los procedimientos quirúrgicos doble y triple, en pacientes operados de enfermedades de la córnea en el Servicio de Oftalmología del Hospital Clínicouirúrgico “Hermanos Ameijeiras” de Ciudad de La Habana, desde julio de 2003 hasta diciembre de 2005. La muestra estuvo constituida por 45 ojos operados de trasplante de córnea entre enero de 1988 y junio de 2003 en el Servicio de Oftalmología del Hospital Clínicoquirúrgico “Hermanos Ameijeiras” de Ciudad de La Habana. Las variables estudiadas fueron: edad, sexo, antecedentes personales oculares, enfermedad corneal previa, retrasplante, viabilidad del injerto corneal, complicaciones ocurridas durante la cirugía y después de esta, agudeza visual prequirúrgica y posquirúrgica, error de cálculo de la lente intraocular y de refracción. Se obtuvo como resultado: predominio del sexo masculino (51,1%, edad promedio 60,27 años, la enfermedad ocular asociada más frecuente en el doble y triple procedimiento fue el glaucoma con 22,7 % y 26,1 % respectivamente, la enfermedad corneal más común fue la distrofia epitelio-endotelial de Fuchs en ambos procederes (72,7 % y 52,2 %; no tuvieron complicaciones transquirúgicas 90,9 % y 95,5 %, respectivamente. Las complicaciones posquirúrgicas fueron de 9,1 % en el doble procedimiento y de 26,1 en el triple. La opacidad corneal posoperatoria se presentó en el doble proceder en 9,1 % y en el triple en 17,4 %. Hubo más retrasplantes en el triple procedimiento (17,4 %. El error refractivo final en el doble procedimiento presentó mayor cantidad emétropes y menos hipermétropes que el triple, mientras que en relación con los miopes se encontró, solo en el doble procedimiento, mejor agudeza visual en el doble procedimiento. El error de cálculo de lente intraocular fue mayor en el triple procedimiento.A retrospective descriptive study was

Farmacovigilancia de la sertralina en pacientes cubanos con episodio de depresión mayor

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Leslie Pérez Ruiz

2011-03-01

Full Text Available En la depresión predominan síntomas como: desinterés, fatiga, sentimientos de inutilidad, desconcentración, deseos de muerte e insomnio. Entre los medicamentos para tratarla se encuentra la sertralina. Con el objetivo de evaluar su seguridad, se revisaron 40 historias clínicas y cuadernos de recogida de datos de los pacientes incluidos en ensayo clínico fase III, aletatorizado, controlado y a doble ciegas: "Uso de sertralina en pacientes con episodio de depresión mayor", pertenecientes al Hospital "Dr. Gustavo Aldereguía Lima". Se obtuvieron datos demográficos, clínicos y eventos adversos, con los cuales se realizó un estudio descriptivo, observacional y transversal que clasifica como un estudio de utilización de medicamentos sobre consecuencias prácticas. La información fue analizada mediante SPSS, versión 13.0 para Windows. De los 40 pacientes incluidos, 24 presentaron eventos adversos para un 60 %; de ellos, 16 (67 % en el grupo tratado con sertralina y 8 (33 % en los tratados con placebo. Los eventos adversos más frecuentes fueron: disminución de peso, sequedad bucal, cefalea, diarreas y náuseas. En su mayoría resultaron de intensidad ligera, causalidad probable y sin necesidad de tratamiento. El uso del fármaco se consideró seguro en el tratamiento de estos pacientes.

Predicting placebo response in adolescents with major depressive disorder: The Adolescent Placebo Impact Composite Score (APICS).

Science.gov (United States)

Nakonezny, Paul A; Mayes, Taryn L; Byerly, Matthew J; Emslie, Graham J

2015-09-01

The aim of this study was to construct a composite scoring system to predict the probability of placebo response in adolescents with Major Depressive Disorder (MDD). Participants of the current study were 151 adolescents (aged 12-17 years) who were randomized to the placebo arm (placebo transdermal patches) of a randomized controlled trial (RCT) comparing the selegiline transdermal patch with placebo (DelBello et al., 2014). The primary outcome of response was defined as a CGI-I score of 1 or 2 (very much or much improved) at week 12 (study-end) or exit. As a first step, a multiple logistic mixed model was used to estimate the odds of placebo response from each predictor in the model, including age, CDRS-R total at baseline (depressive symptom severity), history of recurrent depression (yes vs. no), sex (female vs. male), and race (non-Caucasian vs. Caucasian). On the basis of the initial logistic mixed model analysis, we then constructed an Adolescent Placebo Impact Composite Score (APICS) that became the sole predictor in a re-specified Bayesian logistic regression model to estimate the probability of placebo response. Finally, the AUC for the APICS was tested against a nominal area of 0.50 to evaluate how well the APICS discriminated placebo response status. Among the 151 adolescents, with a mean age of 14.6 years (SD = 1.6) and a mean baseline CDRS-R total of 60.6 (SD = 12.1), 68.2% were females, 50.3% was Caucasian, and 39.7% had a history of recurrent depression. Placebo response rate was 58.3%. Based on the logistic mixed model, the re-specified equation with the highest discriminatory ability to estimate the probability of placebo response was APICS = age + (0.32 × CDRS-R Total at baseline) + (-2.85 × if female) + (-5.50 × if history of recurrent depression) + (-5.85 × if non-Caucasian). The AUC for this model was 0.59 (p = .049). Within a Bayesian decision-theoretic framework, in 95.5% of the time, the 10,000 posterior Monte Carlo samples suggested

Placebo interventions for all clinical conditions

DEFF Research Database (Denmark)

Hróbjartsson, Asbjørn; Gøtzsche, Peter C

2010-01-01

Placebo interventions are often claimed to substantially improve patient-reported and observer-reported outcomes in many clinical conditions, but most reports on effects of placebos are based on studies that have not randomised patients to placebo or no treatment. Two previous versions of this re...... of this review from 2001 and 2004 found that placebo interventions in general did not have clinically important effects, but that there were possible beneficial effects on patient-reported outcomes, especially pain. Since then several relevant trials have been published.......Placebo interventions are often claimed to substantially improve patient-reported and observer-reported outcomes in many clinical conditions, but most reports on effects of placebos are based on studies that have not randomised patients to placebo or no treatment. Two previous versions...

Estudo prospectivo, duplo cego e cruzado da Camellia sinensis (chá verde nas dislipidemias Estudio prospectivo, doble ciego y cruzado de la Camellia sinensis (té verde en las dislipidemias Prospective double-blind crossover study of Camellia sinensis (green tea in dyslipidemias

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Gesiani de Almeida Pierin Batista

2009-08-01

Full Text Available FUNDAMENTO: Estudos epidemiológicos estabeleceram uma associação entre dislipidemias e aterosclerose. A terapia nutricional é um ponto central da estratégia preventiva em indivíduos que apresentam fatores de risco para doença aterosclerótica. OBJETIVOS: Investigar os efeitos do chá verde (Camellia sinensis em pacientes portadores de dislipidemias. MÉTODOS: O estudo envolveu 33 pacientes, com idade entre 21 e 71 anos, que consumiam uma dieta com baixo teor de gorduras (25% a 35% das calorias totais e 200 mg de colesterol por dia. Foram randomizados para dois tratamentos sequenciais: cápsulas contendo 250 mg de extrato seco do chá verde ou placebo, administradas por um período total de 16 semanas, tendo cada paciente utilizado chá verde (Camellia sinensis por oito semanas e placebo em igual período. RESULTADOS: Os valores lipídicos basais (mg/dl foram os seguintes: HDL-colesterol 60,7 ± 7,3; colesterol total 255 ± 30,9; LDL-colesterol 158,8 ± 29,0; triglicerídeos 169,0 ± 61,3 e Apo-B 120,2 ± 18,9. As variações lipídicas médias, provocadas pelo uso do chá verde (Camellia sinensis, mostraram uma redução de 3,9 % (p = 0,006 nas concentrações do colesterol total e uma redução de 4,5 % (p = 0,026 do LDL-colesterol. A ingestão de chá verde não influenciou significativamente os níveis de HDL-colesterol, dos triglicerídeos e do Apo-B. Resultados não significativos foram observados na avaliação dos lipídeos sanguíneos (colesterol total e LDL-colesterol com o uso do placebo. CONCLUSÃO: Foi demonstrado o efeito benéfico do chá verde (Camellia sinensis, que reduziu significativamente, em oito semanas, os níveis de colesterol total e LDL-colesterol nesse grupo de pacientes.FUNDAMENTO: Estudios epidemiológicos establecieron una asociación entre dislipidemias y aterosclerosis. La terapia nutricional es un punto central de la estrategia preventiva en individuos que presentan factores de riesgo para enfermedad

Ensaio duplo-cego controlado multicêntrico com topiramato para jogadores patológicos

OpenAIRE

Antonio Marcelo Cabrita de Brito

2012-01-01

O jogo patológico é classificado como um transtorno do controle dos impulsos, que envolve a fissura e a impulsividade para jogar, causando prejuízos sociais. Estudos prévios sugeriram que o topiramato poderia ser mais eficaz do que o placebo no tratamento de alguns transtornos relacionados com impulsividade, tais como transtorno de compulsão alimentar periódico, alcoolismo e dependência de cocaína. O principal objetivo deste estudo foi verificar se o topiramato foi superior ao placebo em cont...

The placebo effect and nothingness

DEFF Research Database (Denmark)

Jensen, Tine

In this paper I shall discuss the placebo effect from a posthuman angle. The placebo effect is a medical conundrum, as it is a medical effect that is produced by “nothing”. Placebo literally means, ”I please”, and the placebo has, among other things, been defined as an inert substance, often...... a calcium pill. Placebos are being used in medical trials to determine how much of the medical effect is caused by other factors than medical. There is a vast amount of literature on the placebo effect and it has been studied since the late 1940’ies, mainly for the purpose of pre-elimination from medical...... trials. It has been studied as an effect of personality traits, as an expectational effect, and from a physiological point of departure. Still it remains a medical riddle how something that is “nothing” can cause a measurable effect? In this paper I shall address this issue from a posthuman angle...

Adelantamiento con vehiculos autónomos en carreteras de doble sentido

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Joshué Pérez

2010-07-01

Full Text Available Resumen: Las investigaciones llevadas a cabo para el control de vehículos autónomos en maniobras cooperativas están en la vanguardia de los Sistemas de Transporte Inteligente (ITS. Ejemplos de esta cooperación se plasman en intersecciones, control de crucero adaptativo (ACC y adelantamientos, entre otros. Los adelantamientos requieren especial atención en un entorno variable, y sobre todo si se aproxima un vehículo en sentido contrario. En el presente artículo se plantea un algoritmo de decisión, un sistema de comunicaciones entre tres vehículos y un controlador borroso para la conducción de un vehículo en una maniobra de adelantamiento. Se han considerado diferentes casos de uso, en los que conviene abortar o terminar la maniobra de adelantamiento en una carretera de doble sentido. Los resultados obtenidos demuestran que, basándonos en el conocimiento humano, se pueden ajustar controladores borrosos para la conducción autónoma de vehículos en maniobras de alto riesgo. Palabras clave: Comunicación entre vehículos, Adelantamientos, Controlador borroso, Vehículos autónomos, GPS

Desarrollo de una bomba reciprocante de doble efecto para desalinización de agua por medio de osmosis inversa

OpenAIRE

Carlos Julián Ospina; Álvaro Pinilla

2008-01-01

El presente artículo describe el trabajo realizado en el desarrollo de un sistema de bombeo para desalinización con membranas de osmosis inversa. El sistema debe cumplir con requerimientos de alta presión (4.8 MPa) y bajos caudales (3.78 L/min), para operar la membrana de osmosis inversa en su rango de mínimo consumo energético. Para cumplir este objetivo se desarrolla un sistema de desplazamiento positivo de acción simple y doble efecto, impulsado con un motoreductor cicloidal. La bomba desa...

Educación mapuche y educación escolar en la Araucanía: ¿doble racionalidad educativa?

OpenAIRE

Quilaqueo Rapimán,Daniel; Quintriqueo Millán,Segundo; Riquelme Mella,Enrique Hernán; Loncón Antileo,Elisa

2016-01-01

Resumen Este artículo aborda la construcción social de una doble racionalidad en el conocimiento educativo mapuche. El marco de referencia sostiene una base epistémica de conocimientos educativos mapuche y la noción de relación con el saber, donde la ecuación pasado incorporado más contexto de acción presente, es igual a prácticas observables. La metodología plantea una crítica epistemológica a la investigación tradicional realizada sobre los pueblos indígenas. Los resultados sintetizan las p...

Evaluación del comportamiento hidráulico en un reactor anaerobio de doble cámara (RADCA)

OpenAIRE

Nancy Rincón; Andres Galindo; Jhonny Pérez

2011-01-01

En la remoción de carga orgánica en un sistema de tratamiento de aguas residuales intervienen los procesos bioquímico y aspectos hidrodinámicos como las características de flujo, régimen de mezcla, tiempos de residencia, geometría del reactor, por otro lado las condiciones de flujo no ideal tales como cortos circuitos, zonas muertas y recirculación interna afectan su desempeño. En esta investigación se evaluó el comportamiento hidráulico de un reactor anaerobio de doble cámara (RADCA) de 5...

SIMULACIÓN ESTACIONARIA DE UN EVAPORADOR DE DOBLE EFECTO PARA JUGO DE TOMATE

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Álvaro Núñez

2012-01-01

Full Text Available En este trabajo se desarrolló un modelo estacionario para simular un sistema evaporador de doble efecto destinado a la concentración de jugo de tomate. Debido a que el licopeno muestra capacidad antioxidante, es deseable que su concentración sea máxima en la pasta de tomate. Ello se logra optimizando tanto el diseño como las condiciones de operación del equipo concentrador de jugo. Para alcanzar ese objetivo, se incorporó al modelo la cinética de degradación del licopeno, y se realizó un estudio de sensibilidad para determinar las relaciones que vinculan las variables de proceso. El estudio determinó que el contenido de licopeno en el producto es altamente sensible al tiempo de residencia; mientras que el consumo de vapor está determinado por la presión del vapor de servicio y las presiones de los efectos.

MODELO MATEMÁTICO APLICADO A LA CURVA DE LACTANCIA EN GANADO VACUNO DOBLE PROPÓSITO

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Luz Botero

2006-05-01

Full Text Available hembras vacunas. Materiales y métodos. Durante 11 meses, se estudió la producción de leche en 500novillas doble propósito Bos taurus x Bos indicus, de las sabanas del trópico bajo colombiano. Laproducción se cuantificó en kilogramos. Se incluyeron los datos de la producción de leche en época(seca-lluviosa y número de lactancias (primera; segunda y tercera y, más de tres. Los datos hacen partedel archivo de la Ganadería XB, ubicada en las sabanas de Bolívar, Colombia, recopilados desde el año1990 hasta el 2000. A estos datos se le aplicó los modelos lineal simple, cuadrático, lineal logarítmico,cuadrático logarítmico, gamma incompleto, lineal hiperbólico y polinomial inverso. Los parámetros paralos modelos gamma incompleto y polinomial inverso fueron estimados, a partir del método de “Gauss-Newton”, para la regresión no lineal; los demás modelos fueron ajustados por regresión lineal de lasproducciones, en función de los meses en lactancia, por el método de los cuadrados mínimos. Resultados.En los modelos propuestos, se observó que el modelo polinomial inverso es el que mejor caracteriza lacurva de lactancia por presentar los mayores valores para el estadístico Durbin-Watson y coeficiente dedeterminación (R2 y sobre dicho modelo existe información necesaria para obtener parámetros prácticoscalculados a partir de la ecuación de la curva de lactancia. Conclusión. El modelo matemático polinomialinverso se constituye en una excelente herramienta para aplicar en la administración y toma de decisionesen el manejo de hatos del sistema de doble propósito

Control de gestión en unidades de producción de ganadería de doble propósito

OpenAIRE

Martínez, Edmar; López, María Isolina

2012-01-01

La empresa agropecuaria, al igual que las empresas comerciales, manufactureras o de servicios, requiere ser gerenciada con criterios administrativos que le permitan mejorar su proceso productivo, el uso eficiente de los recursos e incrementar su rentabilidad. Esta investigación tuvo como objetivo analizar el control de gestión utilizado en unidades de producción de ganadería de doble propósito del municipio Colón del Estado Zulia. La población estuvo conformada por el 10% de 903 f...

Are all placebo effects equal? Placebo pills, sham acupuncture, cue conditioning and their association.

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Jian Kong

Full Text Available Placebo treatments and healing rituals have been used to treat pain throughout history. The present within-subject crossover study examines the variability in individual responses to placebo treatment with verbal suggestion and visual cue conditioning by investigating whether responses to different types of placebo treatment, as well as conditioning responses, correlate with one another. Secondarily, this study also examines whether responses to sham acupuncture correlate with responses to genuine acupuncture. Healthy subjects were recruited to participate in two sequential experiments. Experiment one is a five-session crossover study. In each session, subjects received one of four treatments: placebo pills (described as Tylenol, sham acupuncture, genuine acupuncture, or no treatment rest control condition. Before and after each treatment, paired with a verbal suggestion of positive effect, each subject's pain threshold, pain tolerance, and pain ratings to calibrated heat pain were measured. At least 14 days after completing experiment one, all subjects were invited to participate in experiment two, during which their analgesic responses to conditioned visual cues were tested. Forty-eight healthy subjects completed experiment one, and 45 completed experiment two. The results showed significantly different effects of genuine acupuncture, placebo pill and rest control on pain threshold. There was no significant association between placebo pills, sham acupuncture and cue conditioning effects, indicating that individuals may respond to unique healing rituals in different ways. This outcome suggests that placebo response may be a complex behavioral phenomenon that has properties that comprise a state, rather than a trait characteristic. This could explain the difficulty of detecting a signature for "placebo responders." However, a significant association was found between the genuine and sham acupuncture treatments, implying that the non

Modelo de un rectificador controlado para estudios de propagación de armónicos

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José A González Quintero

2011-03-01

Full Text Available Se describe un modelo matemático para simular un convertidor trifásico puente completamente controlado que sealimenta de una fuente de voltajes distorsionados. El objetivo consiste en obtener expresiones analíticas que permitanencontrar las corrientes inyectadas por este dispositivo a la red eléctrica de alimentación. Analizando solamente doscircuitos, de los doce que pueden sucederse a medida que las válvulas conmutan durante un período completo deoscilación del voltaje, el trabajo se simplifica notablemente.  This work describes a mathematical model to simulate a fully controlled AC-DC three-phase converter supplied from adistorted voltage source. The goal is obtain analytic expressions that permit to find the injected currents of this deviseto the source electric network. Analyzing only two circuits, of the twelve that can appear every time the convertervalves switches in an entire voltage oscillation period, the work is notably simplified.

Dieta elevada em carboidratos complexos minimiza necessidade de suplementação durante jogo-treino de rúgbi: foco no sistema imune

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Cândido, Rafael Frata; Barboza, Saulo Delfino; Rogerio, Alexandre de Paula; Mota, Gustavo Ribeiro da; Mendes, Edmar Lacerda

2017-01-01

Resumo O estudo analisou a imunidade oral após treino de rúgbi em atletas submetidos à dieta com alto teor de carboidratos (DATC). Em estudo randomizado, duplo-cego e placebo controlado, 20 atletas consumiram DATC por três dias antes do experimento. Os atletas receberam aleatoriamente bebida carboidratada (CHO) ou placebo (PLA) e participaram de duas sessões de treino de rúgbi, separados por sete dias. Coletas de saliva foram feitas antes (Pré-E), imediatamente após (Pós-E) e 1 h após (1 h Pó...

Eficacia de los antivirales en la parálisis de Bell

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Vázquez, María Cristina; Sánchez, Nury; Calvo, Judith; Perna, Abayubá

2008-01-01

Introducción: la parálisis de Bell es una afección frecuente que presenta en 15% de los casos una recuperación incompleta. En los últimos años se ha acumulado evidencia del posible rol del virus herpes simple tipo 1 en su etiología. Objetivos: comparar la eficacia de valaciclovir y prednisona versus prednisona placebo en la parálisis de Bell. Material y método: se realizó un ensayo prospectivo, randomizado y placebo controlado. De los 41 pacientes incluidos, 21 fueron tratados con valaciclovi...

Mood Predicts Response to Placebo CPAP

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Carl J. Stepnowsky

2012-01-01

Full Text Available Study Objectives. Continuous positive airway pressure (CPAP therapy is efficacious for treating obstructive sleep apnea (OSA, but recent studies with placebo CPAP (CPAP administered at subtherapeutic pressure have revealed nonspecific (or placebo responses to CPAP treatment. This study examined baseline psychological factors associated with beneficial effects from placebo CPAP treatment. Participants. Twenty-five participants were studied with polysomnography at baseline and after treatment with placebo CPAP. Design. Participants were randomized to either CPAP treatment or placebo CPAP. Baseline mood was assessed with the Profile of Mood States (POMS. Total mood disturbance (POMS-Total was obtained by summing the six POMS subscale scores, with Vigor weighted negatively. The dependent variable was changed in apnea-hypopnea index (ΔAHI, calculated by subtracting pre- from post-CPAP AHI. Negative values implied improvement. Hierarchical regression analysis was performed, with pre-CPAP AHI added as a covariate to control for baseline OSA severity. Results. Baseline emotional distress predicted the drop in AHI in response to placebo CPAP. Highly distressed patients showed greater placebo response, with a 34% drop (i.e., improvement in AHI. Conclusion. These findings underscore the importance of placebo-controlled studies of CPAP treatment. Whereas such trials are routinely included in drug trials, this paper argues for their importance even in mechanical-oriented sleep interventions.

Alcance jurídico fiscal del establecimiento permanente de empresas extranjeras en los convenios de doble imposición internacional

OpenAIRE

Bermeo Córdova, Carmen Lucía

2013-01-01

Los convenios de doble imposición internacional surgen ante la necesidad de regular aquellas situaciones en las que dos potestades fiscales ejercen su facultad tributaria gravando la actividad de un mismo sujeto pasivo y dentro de un mismo período. Este fenómeno, más allá de crear un conflicto entre los Estados, constituye un obstáculo para el libre intercambio de bienes y servicios, por lo que ha sido motivo de análisis y discusión de organismos internacionales y regionales, entre ellos, la ...

La doble historia de El convidado de papel

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Ceballos Viro, Álvaro

2011-12-01

Full Text Available This article sets out to question the textual history of El convidado de papel, a novel by Benjamín Jarnés. The differences between the two firsts editions of this novel, published in 1928 and 1935, are more complex than has hitherto been assumed. They also allow to reconstruct a different plot from the one that can be found in literary histories. In its original version, El convidado de papel was not only a peculiar Bildungsroman, but also a typical doppelgänger narrative. Therefore, it contained a dense web of intertextual references which Jarnés deliberately eliminated in the second edition of the novel. These intertextual references stimulate the search for new sources as well as the re-evaluation of the precise mode of influence attributed to familiar sources.La presente contribución comienza problematizando la historia textual de El convidado de papel, de Benjamín Jarnés. Las diferencias entre las dos primeras ediciones, que datan de 1928 y 1935, no sólo son más complejas de lo que hasta ahora se había creído, sino que además permiten reconstruir un argumento diferente de aquél tácitamente consensuado por la historiografía literaria. Sin dejar de ser una peculiar novela de formación, El convidado de papel era en su versión original una novela de doble en toda regla, lo que la abría a unas relaciones intertextuales que Jarnés eliminó conscientemente en la segunda edición. Tales relaciones permiten, por un lado, sugerir nuevas influencias (o modos de influencia en la narrativa jarnesiana y, por otro lado, profundizar en las deudas contraídas con autores cuyo ascendiente ya era conocido por la crítica.

Placebo effects in competitive sport: qualitative data.

Science.gov (United States)

Beedie, Christopher J

2007-01-01

The paper examines the placebo effect in sports performance. The possibility that the placebo effect is a more common phenomenon than the quantity of published research would suggest is briefly addressed. It is suggested that the placebo control design often used in sports performance research masks any placebo effects and thus presents a false picture of the mechanisms underlying performance-enhancing interventions in the real world. An electronic survey was sent to 48 competitive, international and professional athletes. Questions related to the placebo effect in competitive sport. Thirty responses were received. Data indicate that the majority (97%) of respondents believe that the placebo effect can exert an influence on sports performance, and that a significant number (73%) have experienced what they defined as a placebo effect. Inductive content analysis reveals that these experiences fall into several categories such as explicit placebo effects, inadvertent false beliefs, ritual and reverse placebo effects. Furthermore, 10 respondents (33%) offer explanations as to the nature of the placebo effect. Again, inductive content analysis reveals that these explanations fall into several categories including deliberate changes in competitive strategy, belief/expectancy, faith in a third party, and marketing. Overall, responses support previous experimental research and anecdotal reports that have found a relationship between belief and sports performance. It is suggested that further research be structured to not simply control for the placebo effect, but to elucidate it. Key pointsA survey of 30 athletes revealed that 73% have experienced a placebo effect in sport.Athletes suggest several potential explanations for these effects.Findings support the idea that placebo effects might be common in sport.Researchers and practitioners should be aware of the possible impact of these effects on research findings and competitive performance.

Placebo Effects and Informed Consent.

Science.gov (United States)

Alfano, Mark

2015-01-01

The concepts of placebos and placebo effects refer to extremely diverse phenomena. I recommend dissolving the concepts of placebos and placebo effects into loosely related groups of specific mechanisms, including (potentially among others) expectation-fulfillment, classical conditioning, and attentional-somatic feedback loops. If this approach is on the right track, it has three main implications for the ethics of informed consent. First, because of the expectation-fulfillment mechanism, the process of informing cannot be considered independently from the potential effects of treatment. Obtaining informed consent influences the effects of treatment. This provides support for the authorized concealment and authorized deception paradigms, and perhaps even for outright deceptive placebo use. Second, doctors may easily fail to consider the potential benefits of conditioning, leading them to misjudge the trade-off between beneficence and autonomy. Third, how attentional-somatic feedback loops play out depends not only on the content of the informing process but also on its framing. This suggests a role for libertarian paternalism in clinical practice.

O desempenho terminológico dos descritores em Ciência da Informação do Vocabulário Controlado do SIBi/USP nos processos de indexação manual, automática e semi-automática

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Vania Mara Alves Lima

Full Text Available Avaliou-se o desempenho terminológico, nos processos de indexação manual, automática e semi-automática, dos descritores, do Vocabulário Controlado do SIBi/USP, que representam o domínio da Ciência da Informação. Concluiu-se que os atuais descritores em Ciência da Informação do Vocabulário Controlado do SIBi/USP para representar adequadamente o conteúdo do corpus indexado devem ser ampliados e contextualizados através de definições terminológicas, de maneira a atender as necessidades de informação de seus usuários.

Placebo analgesia: understanding the mechanisms

OpenAIRE

Medoff, Zev M; Colloca, Luana

2015-01-01

Expectations of pain relief drive placebo analgesia. Understanding how expectations of improvement trigger distinct biological systems to shape therapeutic analgesic outcomes has been the focus of recent pharmacologic and neuroimaging studies in the field of pain. Recent findings indicate that placebo effects can imitate the actions of real painkillers and promote the endogenous release of opioids and nonopioids in humans. Social support and observational learning also contribute to placebo a...

PLACEBO EFFECTS IN COMPETITIVE SPORT: QUALITATIVE DATA

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Christopher J. Beedie

2007-03-01

Full Text Available The paper examines the placebo effect in sports performance. The possibility that the placebo effect is a more common phenomenon than the quantity of published research would suggest is briefly addressed. It is suggested that the placebo control design often used in sports performance research masks any placebo effects and thus presents a false picture of the mechanisms underlying performance-enhancing interventions in the real world. An electronic survey was sent to 48 competitive, international and professional athletes. Questions related to the placebo effect in competitive sport. Thirty responses were received. Data indicate that the majority (97% of respondents believe that the placebo effect can exert an influence on sports performance, and that a significant number (73% have experienced what they defined as a placebo effect. Inductive content analysis reveals that these experiences fall into several categories such as explicit placebo effects, inadvertent false beliefs, ritual and reverse placebo effects. Furthermore, 10 respondents (33% offer explanations as to the nature of the placebo effect. Again, inductive content analysis reveals that these explanations fall into several categories including deliberate changes in competitive strategy, belief/expectancy, faith in a third party, and marketing. Overall, responses support previous experimental research and anecdotal reports that have found a relationship between belief and sports performance. It is suggested that further research be structured to not simply control for the placebo effect, but to elucidate it

The early history of the placebo.

Science.gov (United States)

Jütte, Robert

2013-04-01

In the late 18th century the term "placebo" became part of medical jargon. In contrast to the prevailing opinion that it was the Scottish physician and pharmacologist William Cullen (1710-1790) who introduced this expression into medical language in 1772, the credit must be given to another English physician, Alexander Sutherland (born before 1730 - died after 1773). The main reason for administering placebos in late 18th-century medical practice was to satisfy the patient's demand and his expectations. Another reason was obstinancy of the patient: the motivation behind such prescriptions may be summarized as prescribing inert drugs for the satisfaction of the patient's mind, and not with the view of producing any direct remedial effect. In most cases these 18th century physicians did not administer "pure" placebos but resorted to any kind of medicine which they thought simple, feeble, or altogether powerless, non-perturbing medicines. Today we make the distinction between pure placebos (substances with no pharmacological effect, e.g. sugar pills) and impure placebos (substances with pharmacological effect but not on the condition being treated). In the 18th century those physicians who prescribed placebo usually thought of drugs which were considered not very effective in the particular case, e.g. a mild ointment. At the same time, only very few brilliant minds came up with the ingenious idea of using inert substances as placebo. An alternative to milk sugar used as placebo in homeopathy was breadpills. Recent research suggests that expectancy is an integral part of the placebo effect. As early as 1775 the English bishop John Douglas (1721-1807) anticipated the findings of modern research on the placebo effect. Copyright © 2012 Elsevier Ltd. All rights reserved.

How placebos change the patient's brain.

Science.gov (United States)

Benedetti, Fabrizio; Carlino, Elisa; Pollo, Antonella

2011-01-01

Although placebos have long been considered a nuisance in clinical research, today they represent an active and productive field of research and, because of the involvement of many mechanisms, the study of the placebo effect can actually be viewed as a melting pot of concepts and ideas for neuroscience. Indeed, there exists not a single but many placebo effects, with different mechanisms and in different systems, medical conditions, and therapeutic interventions. For example, brain mechanisms of expectation, anxiety, and reward are all involved, as well as a variety of learning phenomena, such as Pavlovian conditioning, cognitive, and social learning. There is also some experimental evidence of different genetic variants in placebo responsiveness. The most productive models to better understand the neurobiology of the placebo effect are pain and Parkinson's disease. In these medical conditions, the neural networks that are involved have been identified: that is, the opioidergic-cholecystokinergic-dopaminergic modulatory network in pain and part of the basal ganglia circuitry in Parkinson's disease. Important clinical implications emerge from these recent advances in placebo research. First, as the placebo effect is basically a psychosocial context effect, these data indicate that different social stimuli, such as words and rituals of the therapeutic act, may change the chemistry and circuitry of the patient's brain. Second, the mechanisms that are activated by placebos are the same as those activated by drugs, which suggests a cognitive/affective interference with drug action. Third, if prefrontal functioning is impaired, placebo responses are reduced or totally lacking, as occurs in dementia of the Alzheimer's type.

Eva en el Paraíso: La construcción y representación del cuerpo femenino en la playa como espacio turístico en Costa Rica

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Esteban Barboza Núñez

2016-10-01

Full Text Available El artículo analiza la representación del cuerpo femenino como destino turístico, en la promoción de las playas en Costa Rica. Se hace un esbozo del estatus de la figura femenina en el imaginario androcéntrico occidental, desde sus raíces judeocristianas y de pensamiento clásico, hasta el advenimiento de la modernidad. Se reseñan postulados acerca del estatus del cuerpo femenino y la forma en que se construye en las representaciones gráficas; se parte de que la manera en que el cuerpo femenino es representado en la publicidad, enfocada a atraer turistas a la playa, le genera una doble otredad. La primera como mujer, cuyo físico es controlado por un imaginario androcéntrico que lo usa cual Eva-sirena, que tienta y atrae al posible visitante. La segunda como elemento que recrea una fantasía de exploración colonial de una playa prístina y “virginal”, y que la aleja de la modernidad racional cartesiana, en la cual la mente se impone a un cuerpo que debe ser controlado y domesticado por la razón.

Semiotics and the placebo effect.

Science.gov (United States)

Miller, Franklin G; Colloca, Luana

2010-01-01

Despite substantial progress in elucidating its neurobiological mechanisms, theoretical understanding of the placebo effect is poorly developed. Application of the semiotic theory developed by the American philosopher Charles Peirce offers a promising account of placebo effects as involving the apprehension and response to signs. The semiotic approach dovetails with the various psychological mechanisms invoked to account for placebo effects, such as conditioning and expectation, and bridges the biological and cultural dimensions of this fascinating phenomenon.

Neurobiological mechanisms of placebo responses.

Science.gov (United States)

Zubieta, Jon-Kar; Stohler, Christian S

2009-03-01

Expectations, positive or negative, are modulating factors influencing behavior. They are also thought to underlie placebo effects, potentially impacting perceptions and biological processes. We used sustained pain as a model to determine the neural mechanisms underlying placebo-induced analgesia and affective changes in healthy humans. Subjects were informed that they could receive either an active agent or an inactive compound, similar to routine clinical trials. Using PET and the mu-opioid selective radiotracer [(11)C]carfentanil we demonstrate placebo-induced activation of opioid neurotransmission in a number of brain regions. These include the rostral anterior cingulate, orbitofrontal and dorsolateral prefrontal cortex, anterior and posterior insula, nucleus accumbens, amygdala, thalamus, hypothalamus, and periaqueductal grey. Some of these regions overlap with those involved in pain and affective regulation but also motivated behavior. The activation of endogenous opioid neurotransmission was further associated with reductions in pain report and negative affective state. Additional studies with the radiotracer [(11)C]raclopride, studies labeling dopamine D2/3 receptors, also demonstrate the activation of nucleus accumbens dopamine during placebo administration under expectation of analgesia. Both dopamine and opioid neurotransmission were related to expectations of analgesia and deviations from those initial expectations. When the activity of the nucleus accumbens was probed with fMRI using a monetary reward expectation paradigm, its activation was correlated with both dopamine, opioid responses to placebo in this region and the formation of placebo analgesia. These data confirm that specific neural circuits and neurotransmitter systems respond to the expectation of benefit during placebo administration, inducing measurable physiological changes.

Mapas temáticos de isolíneas de sequía Meteorológica para el municipio Florencia (Ciego de Ávila, Cuba

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Yurisbel Gallardo Ballat

2015-03-01

Full Text Available Se presentan los resultados de un estudio desarrollado en el municipio Florencia de la provincia Ciego de Ávila en el período comprendido desde el año 1970 al 2010, a partir de la elaboración de mapas temáticos de isolíneas de sequías meteorológicas, con la utilización de 11 equipos pluviométricos distribuidos dentro del área de estudio y en zonas adyacentes. Se demuestra que es posible la elaboración de mapas de ocurrencia de sequías con la utilización del índice de Déficit de Precipitación Normalizado (DPN a partir de los cuales se pueden determinar áreas proclives a soportar de forma frecuente este peligro de origen natural. Los mapas elaborados brindan a los usuarios agrícolas facilidades para la toma de decisiones con vista al desarrollo más seguro de los cultivos en sistemas agrícolas de secano.

Doble Aneuploidia (Trisomia 21 Y XXY): Reporte de caso de Sindrome Down-Klinefelter con delecion (XP)(P11.3-Pter) heredada

OpenAIRE

De La Torre-Hernandez, Carlos A; Ochoa-Sifontes, Julio C

2015-01-01

En los síndromes Down (SD) y Klinefelter (SK) independientes entre si, ambas aneuploidías cromosómicas son causadas por exceso. La ocurrencia de estas dos alteraciones en un individuo es un fenómeno relativamente raro. En casos de doble aneuploidiìa donde están involucrados autosomas y cromosomas sexuales, predominan las manifestaciones clínicas relacionadas con los autosomas y se solapan las de cromosomas sexuales. Caso clínico: se trata de un paciente de dos anÞos de edad, con signos sugere...

Acupuncture, psyche and the placebo response.

Science.gov (United States)

Enck, Paul; Klosterhalfen, Sibylle; Zipfel, Stephan

2010-10-28

With growing use of acupuncture treatment in various clinical conditions, the question has been posed whether the reported effects reflect specific mechanisms of acupuncture or whether they represent placebo responses, as they often are similar in effect size and resemble similarities to placebo analgesia and its mechanisms. We reviewed the available literature for different placebos (sham procedures) used to control the acupuncture effects, for moderators and potential biases in respective clinical trials, and for central and peripheral mechanisms involved that would allow differentiation of placebo effects from acupuncture and sham acupuncture effects. While the evidence is still limited, it seems that biological differences exist between a placebo response, e.g. in placebo analgesia, and analgesic response during acupunture that does not occur with sham acupuncture. It seems advisable that clinical trials should include potential biomarkers of acupuncture, e.g. measures of the autonomic nervous system function to verify that acupuncture and sham acupuncture are different despite similar clinical effects. Copyright © 2010 Elsevier B.V. All rights reserved.

Los Sofistas y la Antilogía. Sobre las Estructuras Argumentales en los "Discursos Dobles" y en Gorgias

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Alejandro Ramírez Figueroa

2016-06-01

Full Text Available RESUMEN: Se examina la estructura lógica de la antilogía como forma de pensamiento ejercida por los sofistas. Se sostiene que, si bien en los argumentos antilógicos se encuentran falacias de tipo no formal, al menos algunos de tales razonamientos no son falacias desde un punto de vista simbólico formal, sino que poseen estructuras que hoy se pueden reconstruir como esquemas con validez lógica. Se analizan específicamente dos lugares de argumentaciones sofistas: los denominados Discursos dobles, textos anónimos del IV AC, y la obra principal de Gorgias. Se identifican en ellos 8 argumentos con estructura lógica válida.

Differential effectiveness of placebo treatments

DEFF Research Database (Denmark)

Meissner, Karin; Fässler, Margrit; Rücker, Gerta

2013-01-01

IMPORTANCE When analyzing results of randomized clinical trials, the treatment with the greatest specific effect compared with its placebo control is considered to be the most effective one. Although systematic variations of improvements in placebo control groups would have important implications...... relevant sources through February 2012 and contacted the authors to identify randomized clinical trials on the prophylaxis of migraine with an observation period of at least 8 weeks after randomization that compared an experimental treatment with a placebo control group. We calculated pooled random-effects...... and sham surgery are associated with higher responder ratios than oral pharmacological placebos. Clinicians who treat patients with migraine should be aware that a relevant part of the overall effect they observe in practice might be due to nonspecific effects and that the size of such effects might differ...

Placebo treatment facilitates social trust and approach behavior.

Science.gov (United States)

Yan, Xinyuan; Yong, Xue; Huang, Wenhao; Ma, Yina

2018-05-29

Placebo effect refers to beneficial changes induced by the use of inert treatment, such as placebo-induced relief of physical pain and attenuation of negative affect. To date, we know little about whether placebo treatment could facilitate social functioning, a crucial aspect for well-being of a social species. In the present study, we develop and validate a paradigm to induce placebo effects on social trust and approach behavior (social placebo effect), and show robust evidence that placebo treatment promotes trust in others and increases preference for a closer interpersonal distance. We further examine placebo effects in real-life social interaction and show that placebo treatment makes single, but not pair-bonded, males keep closer to an attractive first-met female and perceive less social anxiety in the female. Finally, we show evidence that the effects of placebo treatment on social trust and approach behavior can be as strong as the effect of intranasal administration of oxytocin, a neuropeptide known for its function in facilitating social cognition and behavior. The finding of the social placebo effect extends our understanding of placebo effects on improvement of physical, mental, and social well-being and suggests clinical potentials in the treatment of social dysfunction.

Observación de la conducta homosexual en un rebaño de vacas mestizas de doble propósito

OpenAIRE

Lozada Melero, Rafael Enrique

2011-01-01

La identificación de la conducta homosexual de las hembras bovinos de la ganadería mestiza de doble propósito en la República Bolivariana de Venezuela, particularmente en el estado Trujillo; ha sido poco estudiada a pesar de ser una importante herramienta en la unidad de producción bajo programas de inseminación artificial. Para determinar la frecuencia de los principales síntomas y signo del celo, así como su relación con el diagnostico de la gestación por vía transrectal, en una finca (...

Importance of placebo effect in cough clinical trials.

Science.gov (United States)

Eccles, Ron

2010-01-01

Cough is a unique symptom because, unlike sneeze and other symptoms, it can be under voluntary control and this complicates clinical trials on cough medicines. All over-the-counter cough medicines (OTC) are very effective treatments because of their placebo effect. The placebo effect is enhanced by expectancy related to advertising, brand, packaging, and formulation. This placebo effect creates a problem for the conduct of clinical trials on OTC cough medicines that attempt to demonstrate the efficacy of a pharmacological agent above that of any placebo effect. Up to 85% of the efficacy of some cough medicines can be attributed to a placebo effect. The placebo effect apparent in clinical trials consists of several components: natural recovery, regression of cough response toward mean, demulcent effect, effect of sweetness, voluntary control, and effects related to expectancy and meaning of the treatment. The placebo effect has been studied most in the pain model, and placebo analgesia is reported to depend on the activation of endogenous opioid systems in the brain; this model may be applicable to cough. A balanced placebo design may help to control for the placebo effect, but this trial design may not be acceptable due to deception of patients. The placebo effect in clinical trials may be controlled by use of a crossover design, where feasible, and the changes in the magnitude of the placebo effect in this study design are discussed.

Colaboración Cochrane Iberoamericana-Colombia región Antioquia y viejo Caldas. Identificación y descripción de los ensayos clínicos controlados publicados durante el período 1948 -1998

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Jorge Pérez

2002-03-01

Full Text Available Objective: To locate with the highest possible exhaustiveness and then to describe the clinical trials (CT with random distribution published in the region. This information may allow a larger knowledge of this type of scientific activity, and constitute the departure base for the tasks of the Cochrane Ibero-American Collaboration. Methodology: Manual search of possible controlled clinical trials in the main titles of medical journals in the region. Results: 23 publications were reviewed, in which 53 controlled clinical trials and three randomized clinical trials were found. Conclusions: This is a pioneer work in Antioquia and old Caldas in the search for controlled clinical trials in the main publications between 1948-1998; this work is part of the study “Identification of controlled clinical studies and meta-analysis in Colombian health magazines 1948-1998”, started with the goal of creating a Latin American database specialized in clinical trials, and in this way to be able to compete with the international indexes. Entidades: Escuela de Investigaciones Médicas Aplicadas, Biblioteca Médica, Facultad de Medicina; Sistema de Bibliotecas, Universidad de Antioquia. Objetivo: localizar y describir los ensayos clínicos (EC con distribución aleatoria publicados en la región. Se pretende que esta información permita un mayor conocimiento de este tipo de actividad científica, así como que constituya la base de partida para los trabajos de la Colaboración Cochrane Iberoamericana. Metodología: búsqueda manual en los principales títulos de revistas médicas de la región de los posibles ensayos clínicos controlados. Resultados: se revisaron 23 revistas, en las cuales se encontraron 52 ensayos clínicos controlados y tres ensayos clínicos aleatorizados. Conclusiones: este trabajo es pionero en Antioquia y el viejo Caldas en la búsqueda de ensayos clínicos controlados en las principales publicaciones entre 1948-1998. Hace parte del

Placebo Trends across the Border: US versus Canada.

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Harris, Cory S; Campbell, Natasha K J; Raz, Amir

2015-01-01

Physicians around the world report to using placebos in a variety of situations and with varying degrees of frequency. Inconsistent methodologies, however, complicate interpretation and prevent direct comparisons across studies. While US- and Canada-based physicians share similar professional standards, Canada harbours a less-litigious universal healthcare model with no formal placebo-related policy-factors that may impact how physicians view and use placebos. To compare American and Canadian data, we circulated an online survey to academic physicians practicing in Canada, collected anonymous responses, and extracted those of internists and rheumatologists for comparison to US data obtained through parallel methodologies. Whereas our data show overall concordance across the border-from definitions to ethical limitations and therapeutic potential-differences between American- and Canadian-based placebo practices merit acknowledgement. For example, compared to 45%-80% among US-based respondents, only 23±7% of Canada-based respondents reported using placebos in clinical practice. However, 79±7% of Canada-respondents-a figure comparable to US data-professed to prescribing at least one form of treatment without proven or expected efficacy. Placebo interventions including unwarranted vitamins and herbal supplements (impure placebos) as well as sugar pills and saline injections (pure placebos) appear more common in Canada, where more doctors described placebos as "placebos" (rather than "medications") and used them as a "diagnostic" tool (rather than a means of placating patient demands for treatment). Cross-border variation in the use of clinical placebos appears minor despite substantial differences in health care delivery system, malpractice climate, and placebo-related policy. The prevalence of impure placebos in both Canadian and US clinics raises ethical and practical questions currently unaddressed by policy and warranting investigation.

Efecto de la suplementación con grasa protegida sobre la producción y calidad de carne de toretes mexicanos doble propósito

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German Mendoza M

2011-04-01

Full Text Available Objetivo. Evaluar la respuesta productiva y calidad de la carne de toretes doble propósito a la adición de grasa protegida (GP en su dieta. Materiales y métodos. Se utilizaron 45 toretes comerciales (B. taurus x B. indicus, divididos en tres bloques de 15 animales, de acuerdo con su peso vivo en pequeños, medianos y grandes. Cada bloque fue dividido en tres subgrupos de 5 animales, asignados aleatoriamente a los tratamientos 0, 1.5 y 3% de GP, en un diseño de bloques completamente al azar. Resultados. No hubo diferencias (p>0.05 en comportamiento productivo. La grasa dorsal fue mayor (p0.05 en área del ojo de la costilla (AC ni pH de la carne. El contenido de proteína cruda de la carne incrementó (p0.05 entre tratamientos. Conclusiones. Adicionar GP a dietas para bovinos doble propósito en finalización no modificó la respuesta productiva, pero mejoró algunas características de la canal y de la carne. Se sugiere realizar más investigación, utilizando el mismo tipo de animales, con niveles mayores de GP a los usados en este estudio, ya que la respuesta pudiera mejorar.

Hypnosis: placebo or nonplacebo?

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Van Dyck, R; Hoogduin, K

1990-07-01

According to Grünbaum's definition of placebo, a therapeutic procedure can be considered a nonplacebo if it can be demonstrated that its effects are produced according to the theory upon which the therapy is based. If the theory is adopted that hypnotic effects depend upon mobilization of the patient's hypnotizability, which is a measurable characteristic, a testable theory is provided. Experimental literature is reviewed that shows that placebo effects are not related to hypnotizability. Clinical outcome studies make it clear that results of hypnotherapy are related to hypnotizability in some disorders such as pain and anxiety, but not in the treatment of addiction or habit disorders. An example of a procedure is given in which hypnosis is nonetheless usefully applied for its placebo value as a method to generate positive expectancies.

Placebo Trends across the Border: US versus Canada

Science.gov (United States)

Harris, Cory S.; Campbell, Natasha K. J.; Raz, Amir

2015-01-01

Background Physicians around the world report to using placebos in a variety of situations and with varying degrees of frequency. Inconsistent methodologies, however, complicate interpretation and prevent direct comparisons across studies. While US- and Canada-based physicians share similar professional standards, Canada harbours a less-litigious universal healthcare model with no formal placebo-related policy—factors that may impact how physicians view and use placebos. Methods To compare American and Canadian data, we circulated an online survey to academic physicians practicing in Canada, collected anonymous responses, and extracted those of internists and rheumatologists for comparison to US data obtained through parallel methodologies. Results Whereas our data show overall concordance across the border—from definitions to ethical limitations and therapeutic potential—differences between American- and Canadian-based placebo practices merit acknowledgement. For example, compared to 45%-80% among US-based respondents, only 23±7% of Canada-based respondents reported using placebos in clinical practice. However, 79±7% of Canada-respondents—a figure comparable to US data—professed to prescribing at least one form of treatment without proven or expected efficacy. Placebo interventions including unwarranted vitamins and herbal supplements (impure placebos) as well as sugar pills and saline injections (pure placebos) appear more common in Canada, where more doctors described placebos as “placebos” (rather than “medications”) and used them as a “diagnostic” tool (rather than a means of placating patient demands for treatment). Interpretation Cross-border variation in the use of clinical placebos appears minor despite substantial differences in health care delivery system, malpractice climate, and placebo-related policy. The prevalence of impure placebos in both Canadian and US clinics raises ethical and practical questions currently unaddressed

Blind parents: their experience in care for their children Padres ciegos: experiencias sobre el cuidado de los hijos Pais cegos: experiências sobre o cuidado dos seus filhos

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Lorita Marlena Freitag Pagliuca

2009-04-01

Full Text Available This study reflects on the difficulties and strategies of blind parents to take care of their children. The situations were related to breastfeeding, bathing, feeding, domestic accidents and administering medication. They use touch, hearing, smelling and the support network, contributing to their autonomy.Reflexiones sobre las dificultades y las estrategias que los padres ciegos usan cuando cuidan a sus hijos. Las situaciones se refieren a amamantar, bañar, alimentar, accidentes domésticos y dar remedios; también sobre el uso del tacto, la audición y el olfato. La importancia de la red social que contribuye para su autonomía.Reflexões sobre dificuldades e estratégias de pais cegos, quando cuidam de seus filhos. As situações referiam-se a amamentar, banhar, alimentar, acidentes domésticos e dar remédio, e o tato, audição e olfato e a rede social contribuindo para sua autonomia.

Efeito a Iongo prazo do budesonido inalado na doença pulmonar obstrutiva crónica ligeira e moderada: ensaio controlado e randomizado

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Jørgen Yestbo

2000-07-01

Full Text Available RESUMO: Pouco se sabe acerca da eficácia dos corticoids inalados na Doença Pulmonar Obstrutiva Crónica (DPOC.Os autores investigaram a eficácia do Budesonido inalado no declfnio da função pulmonar e nos sintornas respirntórios, num estudo de doentes com DPOC, com a duraçãao de 3 anos, controlado com placebo.Relativamente ao método, foi utilizado um grupo paralelo, randomizado, em dupla ocultação, controlado com placebo, num único centro de escudo, “The Copenhagen City Heart Study”.Os criterios de inclusão foram os seguintes: Ausência de Asma; uma relação de volume expiratório máximo no 1° segundo (VEMS e capacidade vital igual ou inferior a 0.7; Ausência de resposta do VEMS (variação<15% a 1 mg de terbutalina inalada ou a 37.5 mg de prednisolona oral dada uma vez ao dia, durante 10 dias.Foram estudados 290 doentes, medicados com Budesonido, (na dose de 800 μg mais 400 μg diários durante 6 meses, seguidos de 400 μg duas vezes ao dia durante 30 meses ou placebo durante 36 meses. A idade média dos doentes era de 59 anos e o valormédio do VEMS era de 2.37 L ou 86% do valor teórico. 0 parâmetro mais importante foi o declínio do VEMS. A análise teve por objectivo determinar a eficácia terapêutica.A análise dos resultados permitiu verificar que o declínio do VEMS foi inferior ao esperado (no grupo placebo, o declínio foi de 41.8 ml por ano, no grupo tratado com budesonido foi de 45.1 ml/ano. Os autorcs não verificaram melhoria dos sintomas respiratórios no grupo tratado com budesonido. Durante o estudo ocorreram 316 exacerbações, 155 no grupo do budesonido inalado e 161 no grupo placebo. A terapêutica foi bem tolerada.Os autores conclucm que o Budesonido não teve benefício clínico nos doentes estudados com DPOC, questionando-se sobre o papel dos corticóides inalados no tratamento

Informed consent and placebo effects: a content analysis of information leaflets to identify what clinical trial participants are told about placebos.

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Felicity L Bishop

Full Text Available Placebo groups are used in randomised clinical trials (RCTs to control for placebo effects, which can be large. Participants in trials can misunderstand written information particularly regarding technical aspects of trial design such as randomisation; the adequacy of written information about placebos has not been explored. We aimed to identify what participants in major RCTs in the UK are told about placebos and their effects.We conducted a content analysis of 45 Participant Information Leaflets (PILs using quantitative and qualitative methodologies. PILs were obtained from trials on a major registry of current UK clinical trials (the UKCRN database. Eligible leaflets were received from 44 non-commercial trials but only 1 commercial trial. The main limitation is the low response rate (13.5%, but characteristics of included trials were broadly representative of all non-commercial trials on the database. 84% of PILs were for trials with 50:50 randomisation ratios yet in almost every comparison the target treatments were prioritized over the placebos. Placebos were referred to significantly less frequently than target treatments (7 vs. 27 mentions, p<001 and were significantly less likely than target treatments to be described as triggering either beneficial effects (1 vs. 45, p<001 or adverse effects (4 vs. 39, p<001. 8 PILs (18% explicitly stated that the placebo treatment was either undesirable or ineffective.PILs from recent high quality clinical trials emphasise the benefits and adverse effects of the target treatment, while largely ignoring the possible effects of the placebo. Thus they provide incomplete and at times inaccurate information about placebos. Trial participants should be more fully informed about the health changes that they might experience from a placebo. To do otherwise jeopardises informed consent and is inconsistent with not only the science of placebos but also the fundamental rationale underpinning placebo controlled

[Placebo and the relationship between doctors and patients. Overview].

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Scriba, P C

2012-09-01

In medicine, placebos are used both in scientific studies and for practical therapeutic purposes. In evidence-based medicine, the efficacy of treatment may be determined as the difference between the effects of the verum (the active study drug) and the placebo, the latter being a substance lacking specific action on the disease under consideration. However, the improvements in patients' conditions under placebo treatment may be substantial and comparable to those with verum. Genuine placebos predominate in clinical studies, while pseudoplacebos prevail in practical therapy. The term pseudoplacebo can also be applied to many procedures in complementary medicine, including homeopathic medicine (Büchel et al., Placebo in der Medizin, 2011). The comprehensive definition of placebo, as used in a report by the German Medical Association (Büchel et al., Placebo in der Medizin, 2011), states that a placebo effect may occur even when treating with verum. The placebo effect is modulated by the context of the treatment, by the expectations of the patients and the doctors, and by the success of the relationship between doctors and patients. A number of unspecific effects, e.g., spontaneous alleviation, statistical effects, variance with time, methodological errors, in addition to the placebo effect make up the total response that is called"placebo reaction." A complete list of the effectiveness of placebo for all important diseases is still lacking. Further, it is not possible to predict which patients will respond to placebo. Which characteristics of doctors are important (competence, empathy, communicative ability and partnership, trust) in order to achieve a placebo effect, particularly in addition to the verum effect measures of evidence-based medicine? Are there doctors who are better in this than others? Could the nocebo effect weaken the efficacy of treatment in evidence-based medicine? Since a placebo effect may occur in almost any standard therapy, information about

Relieving Pain using Dose-Extending Placebos: A Scoping Review

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Colloca, Luana; Enck, Paul; DeGrazia, David

2017-01-01

Placebos are often used by clinicians, usually deceptively and with little rationale or evidence of benefit, making their use ethically problematic. In contrast with their typical current use, a provocative line of research suggests that placebos can be intentionally exploited to extend analgesic therapeutic effects. Is it possible to extend the effects of drug treatments by interspersing placebos? We reviewed a database of placebo studies, searching for studies that indicate that placebos given after repeated administration of active treatments acquire medication-like effects. We found a total of 22studies in both animals and humans hinting of evidence that placebos may work as a sort of dose extender of active painkillers. Wherever effective in relieving clinical pain, such placebo use would offer several advantages. First, extending the effects of a painkiller through the use of placebos may reduce total drug intake and side effects. Second, dose-extending placebos may decrease patient dependence. Third, using placebos along with active medication, for part of the course of treatment, should limit dose escalation and lower costs. Importantly, provided that nondisclosure is pre-authorized in the informed consent process and that robust evidence indicates therapeutic benefit comparable to that of standard full-dose therapeutic regimens, introducing dose-extending placebos into the clinical arsenal should be considered. This novel prospect of placebo use has the potential to change our general thinking about painkiller treatments, the typical regimens of painkiller applications, and the ways in which treatments are evaluated. PMID:27023425

Selective REM Sleep Deprivation Improves Expectation-Related Placebo Analgesia.

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Chouchou, Florian; Chauny, Jean-Marc; Rainville, Pierre; Lavigne, Gilles J

2015-01-01

The placebo effect is a neurobiological and psychophysiological process known to influence perceived pain relief. Optimization of placebo analgesia may contribute to the clinical efficacy and effectiveness of medication for acute and chronic pain management. We know that the placebo effect operates through two main mechanisms, expectations and learning, which is also influenced by sleep. Moreover, a recent study suggested that rapid eye movement (REM) sleep is associated with modulation of expectation-mediated placebo analgesia. We examined placebo analgesia following pharmacological REM sleep deprivation and we tested the hypothesis that relief expectations and placebo analgesia would be improved by experimental REM sleep deprivation in healthy volunteers. Following an adaptive night in a sleep laboratory, 26 healthy volunteers underwent classical experimental placebo analgesic conditioning in the evening combined with pharmacological REM sleep deprivation (clonidine: 13 volunteers or inert control pill: 13 volunteers). Medication was administered in a double-blind manner at bedtime, and placebo analgesia was tested in the morning. Results revealed that 1) placebo analgesia improved with REM sleep deprivation; 2) pain relief expectations did not differ between REM sleep deprivation and control groups; and 3) REM sleep moderated the relationship between pain relief expectations and placebo analgesia. These results support the putative role of REM sleep in modulating placebo analgesia. The mechanisms involved in these improvements in placebo analgesia and pain relief following selective REM sleep deprivation should be further investigated.

New insights into the placebo and nocebo responses.

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Enck, Paul; Benedetti, Fabrizio; Schedlowski, Manfred

2008-07-31

In modern medicine, the placebo response or placebo effect has often been regarded as a nuisance in basic research and particularly in clinical research. The latest scientific evidence has demonstrated, however, that the placebo effect and the nocebo effect, the negative effects of placebo, stem from highly active processes in the brain that are mediated by psychological mechanisms such as expectation and conditioning. These processes have been described in some detail for many diseases and treatments, and we now know that they can represent both strength and vulnerability in the course of a disease as well as in the response to a therapy. However, recent research and current knowledge raise several issues that we shall address in this review. We will discuss current neurobiological models like expectation-induced activation of the brain reward circuitry, Pavlovian conditioning, and anxiety mechanisms of the nocebo response. We will further explore the nature of the placebo responses in clinical trials and address major questions for future research such as the relationship between expectations and conditioning in placebo effects, the existence of a consistent brain network for all placebo effects, the role of gender in placebo effects, and the impact of getting drug-like effects without drugs.

Observación de la conducta sexual en un rebaño bovino de doble propósito en el estado Trujillo

OpenAIRE

Linares, Eivar

2009-01-01

La identificación de la conducta sexual de los bovinos de la ganadería mestiza de doble propósito en la Republica Bolivariana de Venezuela, ha sido relativamente poco estudiada a pesar de constituir una de las tareas más importantes que se desarrollan en el control reproductivo en un sistema de explotación bajo la técnica de inseminación artificial. Para determinar los principales síntomas y signo del celo asociados a la primera monta de celo observada, en una finca de ganado mestizo de d...

Risk estimation in association with diagnostic techniques in the nuclear medicine service of the Camaguey Ciego de Avila Territory

International Nuclear Information System (INIS)

Barrerras, C.A.; Brigido, F.O.; Naranjo, L.A.; Lasserra, S.O.; Hernandez Garcia, J.

1999-01-01

The nuclear medicine service at the Maria Curie Oncological Hospital, Camaguey, has experience of over three decades in using radiofarmaceutical imaging agents for diagnosis. Although the clinical risk associated with these techniques is negligible, it is necessary to evaluate the effective dose administered to the patient due to the introduction of radioactive substances into the body. The study of the dose administered to the patient provides useful data for evaluating the detriment associated with this medical practice, its subsequently optimization and consequently, for minimizing the stochastic effects on the patient. The aim of our paper is to study the collective effective dose administered by nuclear medicine service to Camaguey and Ciego de Avila population from 1995 to 1998 and the relative contribution to the total annual effective collective dose of the different diagnostic examinations. The studies were conducted on the basis of statistics from nuclear medicine examinations given to a population of 1102353 inhabitants since 1995. The results show that the nuclear medicine techniques of neck examinations with 1168.8 Sv man (1.11 Sv/expl), thyroid explorations with 119.6 Sv man (55.5 mSv/expl) and iodide uptake with 113.7 Sv man (14.0 mSv/expl) are the main techniques implicated in the relative contribution to the total annual effective collective dose of 1419.5 Sv man. The risk estimation in association with diagnostic techniques in the nuclear medicine service studied is globally low (total detriment: 103.6 as a result of 16232 explorations), similar to other published data

Ecología política y geografía crítica de la basura en el Ecuador

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María Fernanda Solíz Torres

2015-03-01

Full Text Available En Ecuador se producen semanalmente 58.829 toneladas de residuos sólidos, de estas, únicamente el 20% se dispone en condiciones adecuadas, el porcentaje restante se distribuye entre vertederos a cielo abierto, botaderos controlados, ríos e incineradores. El  45,5% de municipios refiere la presencia de recicladores informales, y se estima que el porcentaje total de reciclaje (formal e informal es de 14%. Desde una visión de ecología política, el artículo propone un diagnóstico nacional realizado durante los años 2011-2013 mediante entrevistas estructuradas y visitas de campo en cada uno de los sistemas de disposición final cantonales y con ello, visibiliza la estructura y determinación de la crisis doble: cualitativa y cuantitativa de la basura en el Ecuador. 

The Application of Persuasion Theory to Placebo Effects.

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Geers, Andrew L; Briñol, Pablo; Vogel, Erin A; Aspiras, Olivia; Caplandies, Fawn C; Petty, Richard E

2018-01-01

Placebo effects, or positive outcomes resulting from expectations about a treatment, are powerful components of modern medical care. In this chapter, we suggest that our understanding of placebo effects may benefit from more explicitly connecting this phenomenon to the existing empirical psychological literature on persuasion. Persuasion typically involves an attempt to bring about a change in beliefs or attitudes as a result of providing information on a topic. We begin by providing a brief overview of the psychological literature on placebo effects. We then point to connections between this literature and research on persuasive communication. Although some links have been made, these initial connections have predominantly relied on classic theories of persuasion rather than on more contemporary and comprehensive models. Next, we describe a modern theory of persuasion that may facilitate the study of placebo effects and analyze two issues pertinent to the literature on placebo effects from the lens of this model. Specifically, we consider how and when characteristics of a practitioner (e.g., variables such as perceptions of a practitioner's confidence or competence) can influence the magnitude of placebo effects, and how modern persuasion theory can help in understanding the durability of placebo effects over time. We conclude that examining placebo effects as an outcome of persuasive communication would be a fruitful line of future research. © 2018 Elsevier Inc. All rights reserved.

Harnessing placebo effects by targeting expectancies

NARCIS (Netherlands)

Peerdeman, K.J.

2018-01-01

Placebo effects are health improvements, for example pain reduction, due to an inert treatment. These effects are typically ascribed to a person’s expectations about the beneficial outcomes of the placebo. The literature and experimental research in the current dissertation shows that

Nursing knowledge: hints from the placebo effect.

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Zanotti, Renzo; Chiffi, Daniele

2017-07-01

Nursing knowledge stems from a dynamic interplay between population-based scientific knowledge (the general) and specific clinical cases (the particular). We compared the 'cascade model of knowledge translation', also known as 'classical biomedical model' in clinical practice (in which knowledge gained at population level may be applied directly to a specific clinical context), with an emergentist model of knowledge translation. The structure and dynamics of nursing knowledge are outlined, adopting the distinction between epistemic and non-epistemic values. Then, a (moderately) emergentist approach to nursing knowledge is proposed, based on the assumption of a two-way flow from the general to the particular and vice versa. The case of the 'placebo effect' is analysed as an example of emergentist knowledge. The placebo effect is usually considered difficult to be explained within the classical biomedical model, and we underscore its importance in shaping nursing knowledge. In fact, nurses are primarily responsible for administering placebo in the clinical setting and have an essential role in promoting the placebo effect and reducing the nocebo effect. The beliefs responsible for the placebo effect are as follows: (1) interactive, because they depend on the relationship between patients and health care professionals; (2) situated, because they occur in a given clinical context related to certain rituals; and (3) grounded on higher order beliefs concerning what an individual thinks about the beliefs of others. It is essential to know the clinical context and to understand other people's beliefs to make sense of the placebo effect. The placebo effect only works when the (higher order) beliefs of doctors, nurses and patients interact in a given setting. Finally, we argue for a close relationship between placebo effect and nursing knowledge. © 2016 John Wiley & Sons Ltd.

Motivation and placebos: do different mechanisms occur in different contexts?

Science.gov (United States)

Hyland, Michael E

2011-06-27

This paper challenges the common assumption that the mechanisms underlying short-term placebo paradigms (where there is no motivation for health improvement) and long-term placebo paradigms (where patients value improvement in their health) are the same. Three types of motivational theory are reviewed: (i) classical placebo motivation theory that the placebo response results from the desire for therapeutic improvement; (ii) goal activation model that expectancy-driven placebo responses are enhanced when the placebo response satisfies an activated goal; and (iii) motivational concordance model that the placebo response is the consequence of concordance between the placebo ritual and significant intrinsic motives. It is suggested that current data are consistent with the following theory: response expectancy, conditioning and goal activation are responsible for short-term placebo effects but long-term therapeutic change is achieved through the effects of goal satisfaction and affect on the inflammatory response system and hypothalamic-pituitary-adrenal axis. Empirical predictions of this new theory are outlined, including ways in which placebo effects can be combined with other psychologically mediated effects on short-term and long-term psychological and physiological state.

Utilizing placebo mechanisms for dose reduction in pharmacotherapy.

Science.gov (United States)

Doering, Bettina K; Rief, Winfried

2012-03-01

The knowledge and systematic application of the placebo effect remains limited, although its importance to the treatment of various medical conditions has increasingly been recognized. A possible application of the placebo effect to pharmacotherapy is seen in conditioning processes that aim at a placebo-controlled dose reduction of drugs while maintaining the efficacy of the medical treatment. The pairing of a placebo and a pharmacological agent may achieve satisfactory treatment outcomes in combination with a lower dose of medication. This procedure includes classic and instrumental conditioning processes that involve both conscious and non-conscious information processing. Although recent studies have gathered preliminary evidence for the efficacy of placebo-controlled dose reduction (e.g. in psoriasis and attention deficit hyperactivity disorder [ADHD]), they have also illustrated the difficulties that are inherent to this approach. We critically review previous approaches and discuss designs for clinical trials that seem appropriate to the investigation of conditioned placebo effects in pharmacotherapy. Copyright © 2011 Elsevier Ltd. All rights reserved.

Enhancing Placebo Effects: Insights From Social Psychology

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SLIWINSKI, JIM; ELKINS, GARY R.

2012-01-01

Placebo effects are widely recognized as having a potent impact upon treatment outcomes in both medical and psychological interventions, including hypnosis. In research utilizing randomized clinical trials, there is usually an effort to minimize or control placebo effects. However, in clinical practice there may be significant benefits in enhancing placebo effects. Prior research from the field of social psychology has identified three factors that may enhance placebo effects, namely: priming, client perceptions, and the theory of planned behavior. These factors are reviewed and illustrated via a case example. The consideration of social-psychological factors to enhance positive expectancies and beliefs has implications for clinical practice as well as future research into hypnotic interventions. PMID:23488251

Placebo-like analgesia via response imagery

NARCIS (Netherlands)

Peerdeman, K.J.; Laarhoven, A.I.M. van; Bartels, D.J.P.; Peters, M.L.; Evers, A.W.M.

2017-01-01

BACKGROUND: Placebo effects on pain are reliably observed in the literature. A core mechanism of these effects is response expectancies. Response expectancies can be formed by instructions, prior experiences and observation of others. Whether mental imagery of a response can also induce placebo-like

Lower Placebo Responses After Long-Term Exposure to Fibromyalgia Pain.

Science.gov (United States)

Kosek, Eva; Rosen, Annelie; Carville, Serena; Choy, Ernest; Gracely, Richard H; Marcus, Hanke; Petzke, Frank; Ingvar, Martin; Jensen, Karin B

2017-07-01

Knowledge about placebo mechanisms in patients with chronic pain is scarce. Fibromyalgia syndrome (FM) is associated with dysfunctions of central pain inhibition, and because placebo analgesia entails activation of endogenous pain inhibition, we hypothesized that long-term exposure to FM pain would negatively affect placebo responses. In our study we examined the placebo group (n = 37, mean age 45 years) from a 12-week, randomized, double-blind, placebo-controlled trial investigating the effects of milnacipran or placebo. Twenty-two patients were classified as placebo nonresponders and 15 as responders, according to the Patient Global Impression of Change scale. Primary outcome was the change in pressure pain sensitivity from baseline to post-treatment. Secondary outcomes included ratings of clinical pain (visual analog scale), FM effect (Fibromyalgia Impact Questionnaire), and pain drawing. Among placebo responders, longer FM duration was associated with smaller reductions in pressure pain sensitivity (r = .689, P = .004), but not among nonresponders (r = -.348, P = .112). In our study we showed that FM duration influences endogenous pain regulation, because pain levels and placebo-induced analgesia were negatively affected. Our results point to the importance of early FM interventions, because endogenous pain regulation may still be harnessed at that early time. Also, placebo-controlled trials should take FM duration into consideration when interpreting results. This study presents a novel perspective on placebo analgesia, because placebo responses among patients with chronic pain were analyzed. Long-term exposure to fibromyalgia pain was associated with lower placebo analgesia, and the results show the importance of taking pain duration into account when interpreting the results from placebo-controlled trials. Copyright © 2017 The Authors. Published by Elsevier Inc. All rights reserved.

Homeopathic pathogenetic trials produce specific symptoms different from placebo.

Science.gov (United States)

Möllinger, Heribert; Schneider, Rainer; Walach, Harald

2009-04-01

Homeopathy uses information gathered from healthy volunteers taking homeopathic substances (pathogenetic trials) for clinical treatment. It is controversial whether such studies produce symptoms different from those produced by placebo. To test whether homeopathic preparations produce different symptoms than placebo in healthy volunteers. Three armed, double-blind, placebo controlled randomised experimental pathogenetic study in 25 healthy volunteers who took either one of two homeopathic remedies, Natrum muriaticum and Arsenicum album in 30CH or identical placebo. Main outcome parameter was the number of remedy-specific symptoms per group. On average, 6 symptoms typical for Arsenicum album were experienced by participants taking arsenicum album, 5 symptoms typical for Natrum muriaticum by those taking natrum muriaticum, and 11 non-specific symptoms by those in the placebo group. Differences were significant overall (Kruskall Wallis test, p = 0.0002,) and significantly different from placebo (Mann-Whitney test, p = 0.001). Homeopathic remedies produce different symptoms than placebo. Copyright (c) 2009 S. Karger AG, Basel.

Utilización del Boophilus microplus como remedio isopático en el control del ectoparásito en el Municipio de Aguazul (Casanare

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Francisco Javier Niño Murcia

2005-12-01

Full Text Available En este estudio se demostró la efectividad de un remedio isopático vía oral, para el control de la garrapata Boophilus microplus, inocuo para los animales, medio ambiente y el hombre, evitando residuos de plaguicidas en el producto final. La investigación se realizó en una finca ubicada en el municipio de Aguazul (Casanare; localizada a los 05°10’23’’ de latitud norte y 72°33’17’’ de longitud oeste desde Greenwich, altitud: 300 msnm, temperatura media: 27ÚC. Precipitación anual media: 2.441 mm. Se contó con 32 animales de doble propósito; con la propuesta adoptada por la Corporación Colombiana de Investigación Agropecuaria, CORPOICA, en cuanto al Manejo Integrado de Plagas (MIP; acerca del control ejercido con base en niveles críticos, se inició con un conteo de garrapatas, con un tamaño entre 4.5 mm y 8 mm, por un lado del cuerpo del animal; animales con más de 20 garrapatas, entraban en el proceso de investigación, se les administró el remedio isopático, el cual correspondía al grupo A, y el placebo el cual correspondió con el grupo B, durante cuatro días consecutivos. Se administraron dos potencias del remedio, la primera con nueve centésimal (9 C, la cual no tuvo ningún efecto sobre la garrapata, la segunda potencia treinta centesimal (30 C, con la cual se observaron los resultados propuestos sobre la garrapata, se hace un segundo conteo de garrapatas con los mismos tamaños para verificar la efectividad de la segunda potencia; veinticinco días después de la administración, se hizo un último conteo de garrapatas con los mismos tamaños con los cuales se partió. Se utilizó la técnica experimental de doble ciego para obtener datos más veraces. El estudio estadístico se realizó por la técnica de análisis operacional de varianza de dos factores con varias muestras por grupo; los recuentos de garrapatas se trasformaron a la expresión logarítmica: t = Log 10 (X+1, donde X es el recuento de

La resistencia a tracción indirecta del hormigón por doble punzonamiento. Influencia del tamaño máximo del árido y de la excentricidad

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Perepérez Ventura, Bernardo

1985-10-01

Full Text Available After reminding the interest, or the need, to know the concrete tensile strength, and having analyzed critically normal test methods, it /s briefly described the test method of indirect tension by "double punch test", proposed by W. F. Chen. The experimental results obtained on three different concretes, two among them of a common density and a third with expanded clay as coarse aggregate, are shown. It has been proved that for normal density concretes, the tensile strength by "double punch test" has little sensibility to the variation of the aggregate maximum size, opposite to which it takes place in the splitting test, and the error of the centred of the "punch" has a minimum influence on the results, till very high eccentricities are reached. In conclusion, indirect tension test by double punch test is simple, practical and reproducible, responding to the needs to the needs of a commercial routine.Tras recordar el interés o la necesidad de conocer en ocasiones ¡a resistencia a tracción del hormigón y realizar un análisis crítico de los métodos de ensayo al uso, se describe brevemente el método de ensayo de tracción indirecta por "doble punzonamiento" propuesto por W. F. Chen. Se presentan los resultados experimentales obtenidos sobre tres hormigones distintos, dos de densidad ordinaria y un tercero con arcilla expandida como árido grueso. Se ha comprobado que, para hormigones de densidad normal, la resistencia a tracción por "doble punzonamiento" es muy poco sensible a la variación del tamaño máximo del árido, contrariamente a lo que sucede con el ensayo brasileño, y que el error de centrado de los "punch" tiene una influencia mínima sobre los resultados hasta que se alcanzan excentricidades muy altas. Se concluye que el ensayo de tracción indirecta por "doble punzonamiento" es simple, práctico y reproducible, respondiendo a las necesidades de una rutina comercial.

Factores que determinan el uso de innovaciones tecnológicas en la ganadería de doble propósito en Sinaloa, Mexico

OpenAIRE

Venancio Cuevas Reyes; Julio Baca del Moral; Fernando Cervantes Escoto; José Antonio Espinosa García; Jorge Aguilar Ávila; Alfredo Loaiza Meza

2013-01-01

El objetivo del presente estudio fue analizar los factores que inciden en la adopción de innovaciones por parte de productores de bovinos de doble propósito. Mediante selección no estocástica de 121 productores que participaron en el programa Soporte de la SAGARPA en el periodo 2010-2011, se identificaron por medio de estadísticos de posición, tres tipos de productores con diferente uso de tecnología (alto, medio y bajo); por medio de un análisis de varianza y una prueba de Ji-cuadrada se det...

Mechanisms of the placebo response in pain in osteoarthritis.

Science.gov (United States)

Abhishek, A; Doherty, M

2013-09-01

Administration of a placebo associates with symptomatic improvement in many conditions--the so-called placebo response. In this review we explain the concept of placebo response, examine the data that supports existence in osteoarthritis (OA), and discuss its possible mechanisms and determinants. A Pubmed literature search was carried out. Key articles were identified, and their findings discussed in a narrative review. Pain, stiffness, self-reported function and physician-global assessment in OA clearly improve in response to placebo. However, more objective measures such as quadriceps strength and radiographic progression appear less responsive. Although not directly studied in OA, contextual effects, patient expectation and conditioning are believed to be the main mechanisms. Neurotransmitter changes that mediate placebo-induced analgesia include increased endogenous opioid levels, increased dopamine levels, and reduced levels of cholecystokinin. Almost all parts of the brain involved in pain processing are influenced during placebo-induced analgesia. Determinants of the magnitude of placebo response include the patient-practitioner interaction, treatment response expectancy, knowledge of being treated, patient personality traits and placebo specific factors such as the route and frequency of administration, branding, and treatment costs. Clearer understanding of the neurobiology of placebo response validates its existence as a real phenomenon. Although routine administration of placebo for symptomatic improvement is difficult to justify, contextual factors that enhance treatment response should be employed in the management of chronic painful conditions such as OA where available treatments have only modest efficacy. Copyright © 2013 Osteoarthritis Research Society International. Published by Elsevier Ltd. All rights reserved.

Lupus nephritis, pregnancy and rituximab

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Enrique Dorado

2017-04-01

Full Text Available La nefritis lúpica (NL proliferativa es una de las complicaciones más graves del LES. La respuesta terapéutica con los esquemas clásicos no existe en el 20 al 70% de los casos, siendo la amplitud de dicho rango explicada por variaciones étnicas, falta de consenso en la definición de remisión, diferencias en los tiempos de tratamiento, seguimiento y en la clase de NL. En presencia de NL recidivante o refractaria los tratamientos y el nivel de evidencia sobre su eficacia son más limitados. Rituximab es un anticuerpo monoclonal quimérico (ratón-humano dirigido contra el antígeno CD 20 localizado en la superficie celular de los linfocitos B. Estos participan en la patogénesis del LES a partir de su maduración en células plasmáticas, producción de anticuerpos, secreción de citoquinas proinflamatorias, presentación de autoantígenos a las células T y en la activación de células T. La administración de rituximab genera un rápido y sostenido descenso de los linfocitos B CD 20+ circulantes y una reducción de los títulos de auto-anticuerpos. Se reportó una disminución significativa en los niveles de antiDNA a partir de la semana 14 y de los niveles de IgM, sin compromiso de IgG ni de IgA. Se detectó droga activa en sangre periférica luego de la semana 24 de la última infusión. La depleción de linfocitos B se puede mantener por 6 meses, su reconstitución es heterogénea y puede tardar más de un año. Esta linfopenia selectiva tendría un valor predictivo de respuesta terapéutica, la remisión clínica prolongada tendría asociación con repoblación incompleta de células B de memoria varios años luego del tratamiento. En estudios observacionales realizados en pacientes con NL refractaria se reportó respuesta terapéutica con rituximab entre 67-77 % luego de 6 a 12 meses de seguimiento. Sin embargo los resultados del estudio Lupus Nephritis Assesment with Rituximab (LUNAR, randomizado controlado, a doble ciego

Efecto de la atorvastatina en el tratamiento de la periodontitis crónica moderada

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Miriam Rocha Navarro

2008-01-01

Full Text Available Introducción: Las estatinas son inhibidores de la hidroximetil-glutaril Coenzima A reductasa que han sido empleadas para el tratamiento de la hipercolesterolemia. Se ha reportado que tienen efectos favorables sobre el metabolismo óseo disminuyendo el riesgo de fracturas y en algunos estudios un aumento de la densidad mineral ósea. Por lo anterior, el objetivo de este estudio fue comparar el tratamiento periodontal más atorvastatina (ATV sobre los parámetros periodontales y hueso alveolar versus tratamiento periodontal más placebo en pacientes con periodontitis crónica moderada (PCM. Materiales y Métodos: Estudio controlado, doble ciego, aleatorizado, en el que participaron 38 pacientes con PCM de 35 a 65 años, a los cuales se les administró por tres meses un tratamiento con ATV (20 mg/día, n=19 o complejo B (grupo control n=19. Todos los pacientes recibieron el mismo tratamiento periodontal al inicio del estudio. Se tomaron muestras de sangre en ayuno para cuantificar glucosa, perfil de lípidos, fosfatasa alcalina, N-telopéptidos y 17-estradiol. Se evaluaron los siguientes parámetros periodontales: Profundidad de las bolsas periodontales, sangrado gingival, recesión gingival, pérdida de inserción, movilidad dental, y placa dentobacteriana, además de la distancia de la cresta ósea alveolar a la unión cemento esmalte (COA-UCE. Todas las mediciones se realizaron al inicio y al final del estudio. Para el análisis de los datos se utilizó la prueba t para muestras dependientes y su alternativa no paramétrica para observar diferencias entre los dos grupos. La corrección de Bonferroni para comparaciones múltiples fue calculada en base a los valores de P. Para observar diferencias entre los grupos por género y estado menopáusico se utilizó la prueba t para muestras independientes o su alternativa no paramétrica U de Mann-Whitney. Se consideró una p< 0.05 como significativa. Resultados: Los parámetros periodontales mejoraron

Tofacitinib or Adalimumab versus Placebo for Psoriatic Arthritis.

Science.gov (United States)

Mease, Philip; Hall, Stephen; FitzGerald, Oliver; van der Heijde, Désirée; Merola, Joseph F; Avila-Zapata, Francisco; Cieślak, Dorota; Graham, Daniela; Wang, Cunshan; Menon, Sujatha; Hendrikx, Thijs; Kanik, Keith S

2017-10-19

Tofacitinib is an oral Janus kinase inhibitor that is under investigation for the treatment of psoriatic arthritis. We evaluated tofacitinib in patients with active psoriatic arthritis who previously had an inadequate response to conventional synthetic disease-modifying antirheumatic drugs (DMARDs). In this 12-month, double-blind, active-controlled and placebo-controlled, phase 3 trial, we randomly assigned patients in a 2:2:2:1:1 ratio to receive one of the following regimens: tofacitinib at a 5-mg dose taken orally twice daily (107 patients), tofacitinib at a 10-mg dose taken orally twice daily (104), adalimumab at a 40-mg dose administered subcutaneously once every 2 weeks (106), placebo with a blinded switch to the 5-mg tofacitinib dose at 3 months (52), or placebo with a blinded switch to the 10-mg tofacitinib dose at 3 months (53). Placebo groups were pooled for analyses up to month 3. Primary end points were the proportion of patients who had an American College of Rheumatology 20 (ACR20) response (≥20% improvement from baseline in the number of tender and swollen joints and at least three of five other important domains) at month 3 and the change from baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI) score (scores range from 0 to 3, with higher scores indicating greater disability) at month 3. ACR20 response rates at month 3 were 50% in the 5-mg tofacitinib group and 61% in the 10-mg tofacitinib group, as compared with 33% in the placebo group (P=0.01 for the comparison of the 5-mg dose with placebo; Ptofacitinib group and -0.40 in the 10-mg tofacitinib group, as compared with -0.18 in the placebo group (P=0.006 for the comparison of the 5-mg dose with placebo; Ptofacitinib group, 71% in the 10-mg tofacitinib group, 72% in the adalimumab group, 69% in the placebo group that switched to the 5-mg tofacitinib dose, and 64% in the placebo group that switched to the 10-mg tofacitinib dose. There were four cases of cancer, three serious

A double-blind, randomized and placebo-controlled clinical trial with Agaricus sylvaticus fungus in anthropometric profile of women with colon cancer

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Renata Costa Fortes

2015-01-01

ção dietética com fungos Agaricus sylvaticus. Métodos: Ensaio clínico randomizado, duplo-cego, placebo-controlado realizado em um hospital público do Distrito Federal Brasil por seis meses. Amostra constituída por 32 pacientes com câncer colorretal, sexo feminino, separados em dois grupos: suplementado com Agaricus sylvaticus (30 mg/kg/dia e placebo. Realizou-se a antropometria (peso, estatura, índice de massa corporal, circunferência do braço, dobra cutânea tricipital, circunferência muscular do braço e percentual de gordura ao longo do tratamento. Os resultados foram analisados em três momentos distintos (antes do início do tratamento, com três meses e após seis meses de suplementação, utilizando os programas Microsoft Excel 2007 e SPSS 19.0, por meio dos testes T-student e F, com significância para p ≤ 0,05. Resultados: O grupo Agaricus sylvaticus apresentou aumento significativo de índice de massa corporal, circunferência do braço, percentual de gordura corporal e dobra cutânea triciptal e, aumento não significativo de circunferência muscular do braço após seis meses de suplementação. Esses resultados não foram observados no grupo placebo. Conclusão: Os resultados sugerem que a suplementação dietética com Agaricus sylvaticus é capaz de exercer benefícios nos parâmetros antropométricos de mulheres com câncer colorretal. Keywords: Anthropometry, Colorectal cancer, Agaricus sylvaticus fungi, Palavras-chave: Antropometria, Câncer colorretal, Fungos Agaricus sylvaticus

On Suggestibility and Placebo: A Follow-Up Study.

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Lifshitz, Michael; Sheiner, Eli O; Olson, Jay A; Thériault, Rémi; Raz, Amir

2017-04-01

Identifying what makes some people respond well to placebos remains a major challenge. Here, we attempt to replicate an earlier study in which we found a relationship between hypnotic suggestibility and subjective ratings of relaxation following the ingestion of a placebo sedative (Sheiner, Lifshitz, & Raz, 2016). To assess the reliability of this effect, we tested 34 participants using a similar design. Participants ingested a placebo capsule in one of two conditions: (1) relaxation, wherein we described the capsule as a herbal sedative, or (2) control, wherein we described the capsule as inert. To index placebo response, we collected measures of blood pressure and heart rate, as well as self-report ratings of relaxation and drowsiness. Despite using a similar experimental design as in our earlier study, we were unable to replicate the correlation between hypnotic suggestibility and placebo response. Furthermore, whereas in our former experiment we observed a change in subjective ratings of relaxation but no change in physiological measures, here we found that heart rate dropped in the relaxation condition while subjective ratings remained unchanged. Even within a consistent context of relaxation, therefore, our present results indicate that placebos may induce effects that are fickle, tenuous, and unreliable. Although we had low statistical power, our findings tentatively accord with the notion that placebo response likely involves a complex, multifaceted interaction between traits, expectancies, and contexts.

LA RELACIÓN ENTRE TRATADOS DE INVERSIÓN Y CONVENIOS DE DOBLE TRIBUTACIÓN: el caso chileno

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Rodrigo Polanco Lazo

Full Text Available El presente artículo examina las relaciones entre los tratados de inversión y los tratados de doble tributación, considerando que, en la actual evolución de ambos tipos de acuerdos, sus disposiciones pueden presentar superposiciones en aspectos tales como estándares de protección, transparencia, trato nacional, cláusula de la nación más favorecida, expropiación y transferencias de capital. Tomando el ejemplo de los tratados suscritos por Chile, en este trabajo se examinan las consecuencias de las trasposiciones de ambos acuerdos, desde el punto de vista de sus mecanismos de solución de controversias, como en lo referido a los conflictos de jerarquía normativa entre esos dos tipos de tratados. Asimismo, se efectúa un análisis sobre iniciativas de tipo multilateral que afectan a ambas categorías de acuerdos como el Base Erosion and Profit Shifting (BEPS.

Vacunas para la prevención de la gripe en personas de edad avanzada

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Tom Jefferson

2010-09-01

Conclusiones de los autores: Las pruebas disponibles son de calidad deficiente y no proporcionan orientación con respecto a la seguridad, la eficacia o la efectividad de las vacunas contra la gripe en las personas de 65 años de edad o más. Para resolver la incertidumbre se debe realizar un ensayo aleatorio controlado con placebo, con financiamiento público y con poder estadístico adecuado, durante varias estaciones.

Plantas medicinais no tratamento do transtorno de ansiedade generalizada: uma revisão dos estudos clínicos controlados Medicinal plants for the treatment of generalized anxiety disorder: a review of controlled clinical studies

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Thalita Thais Faustino

2010-12-01

Full Text Available OBJETIVO: Revisar os estudos clínicos controlados sobre a efetividade de plantas medicinais/fitoterápicos no transtorno de ansiedade generalizada. MÉTODO: Realizou-se uma busca (Medline, Web of Science, SciELO, Biblioteca Cochrane por artigos originais utilizando as palavras ["plant OR phytomed* OR extract OR herbal OR medicinal (OR specific name plants"] AND ("anxie* OR anxioly* OR tranquil* OR GAD", delimitada a "human OR clinical trial OR randomized controlled trial OR meta-analysis OR review" e à língua inglesa. Os critérios de inclusão foram: estudos randomizados, comparativos e duplo-cegos. RESULTADOS: Foram selecionados sete dos 267 artigos encontrados. O Piper methysticum (kava-kava foi o fitoterápico mais estudado, sendo sugerido um efeito ansiolítico. Entretanto, a maioria destes estudos incluiu outros transtornos de ansiedade e os dois estudos com transtorno de ansiedade generalizada apresentaram resultados contraditórios. Estudos isolados envolvendo Ginkgo biloba, Galphimia glauca, Matricaria recutita (camomila, Passiflora incarnata e Valeriana officinalis indicaram potencial efeito ansiolítico no transtorno de ansiedade generalizada. A Ginkgo biloba e a Matricaria recutita apresentaram um effect size ('d' de Cohen = 0,47 e 0,87 similar ou superior ao dos ansiolíticos atuais (0,17-0,38. Não foram localizados estudos com outras plantas. CONCLUSÃO: Apesar do potencial terapêutico dos fitoterápicos no transtorno de ansiedade generalizada, poucos ensaios clínicos controlados foram identificados, com a maioria apresentando limitações metodológicas.OBJECTIVE: This work aimed to identify controlled trials, which evaluated effectiveness of herbal medicines in subjects suffering generalized anxiety disorder. METHOD: Controlled studies (randomized, comparative with placebo and/or standard drug, double-blind were sought through electronic and hand-searches. The word strategy used "plant OR phytomed* OR extract OR herbal OR

Diseño de Reglas Gramaticales para Transformar Documentos Técnicos Corporativos Escritos en Lenguaje Natural en Discursos Controlados

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Carlos Mario Zapata Jaramillo

2013-04-01

Full Text Available La educción de requisitos es una de las fases más importantes en el proceso de desarrollo de software. La revisión de documentos es una de las técnicas menos usadas para educir requisitos. La literatura sugiere usarla en esta fase sobre descripciones del dominio y documentos corporativos. Aplicando esta técnica, los analistas pueden extraer conocimiento del dominio e información del negocio. En este artículo se define un marco estructural de un tipo de documento técnico corporativo, relacionado con la especificación de procedimientos. A partir de este marco, se propone un conjunto de reglas gramaticales para transformar ciertas secciones del documento técnico en un discurso en el lenguaje controlado UN-Lencep. Estas reglas se pueden aplicar posteriormente en procesos de educción de requisitos a partir de la técnica de revisión de documentos.

Soy in hypercholesterolaemia: a double-blind, placebo-controlled trial.

Science.gov (United States)

Puska, P; Korpelainen, V; Høie, L H; Skovlund, E; Lahti, T; Smerud, K T

2002-04-01

To study whether Abacor, a product based on isolated soy protein with high and standardised levels of isoflavones and cotyledon soy fibres, was more effective in lowering total and LDL cholesterol than placebo. Randomised, placebo-controlled, double-blind, parallel group, single centre study. Primary care in Joensuu, North Karelia, Finland. Subjects were screened from the patient database of the health centre; 30 were randomised to the Abacor group and 30 subjects to placebo. Eight subjects were withdrawn, six from the active group, two from the placebo group. The preparations were given as two daily liquid supplements in addition to the subjects' regular diets for 6 weeks. Abacor showed a statistically significant lipid-lowering effect as compared to placebo, although an unexpected reduction was seen in the placebo group. The estimated difference between active treatment and placebo was 0.25 mmol/l (95% CI 0.01, 0.50; P=0.049) for total cholesterol, corresponding to reductions of 8.3 and 5.1%, respectively. The difference in reduction of LDL-cholesterol was 0.27 mmol/l (95% CI 0.06, 0.49; P=0.014) and corresponded to a reduction of 13.2% in the active treatment group, and 8.0% in the placebo group. Abacor showed a rapid onset of effect, as compared with placebo. During a wash-out period of 4 weeks after treatment, the subjects returned to pre-treatment cholesterol levels. Added to a regular diet, Abacor significantly reduced LDL-cholesterol and total cholesterol. These beneficial effects occurred within 6 weeks of treatment.

Factores que determinan el uso de innovaciones tecnológicas en la ganadería de doble propósito en Sinaloa, Mexico

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Venancio Cuevas Reyes

2013-01-01

Full Text Available El objetivo del presente estudio fue analizar los factores que inciden en la adopción de innovaciones por parte de productores de bovinos de doble propósito. Mediante selección no estocástica de 121 productores que participaron en el programa Soporte de la SAGARPA en el periodo 2010-2011, se identificaron por medio de estadísticos de posición, tres tipos de productores con diferente uso de tecnología (alto, medio y bajo; por medio de un análisis de varianza y una prueba de Ji-cuadrada se determinaron las variables que inciden en la implementación de sus prácticas tecnológicas. El uso promedio de innovaciones resultó significativo (P<0.05 en la diferenciación de los grupos de productores, en tanto las variables significativas (P<0.05 para su descripción fueron el número de vacas adultas, la distancia de la unidad de producción al municipio, el método de reproducción, el tipo de ordeño y los años de recibir asistencia técnica. Se concluye que la tipología realizada permitió identificar tres tipos de productores de acuerdo al uso de innovaciones tecnológicas; por grupo los factores que influyen en la adopción de innovaciones fueron aquéllos relacionados con variables de escala, localización, tecnológicos y de innovación. Los resultados pueden servir para reorientar y planificar programas de transferencia tecnológica en sistemas de producción de doble propósito.

LOS PROCESOS DE ÚNICA INSTANCIA EN EL CÓDIGO GENERAL DEL PROCESO: LA GARANTÍA CONSTITUCIONAL DEL DEBIDO PROCESO Y LA DOBLE INSTANCIA

OpenAIRE

Jiménez Ramírez, Milton César; Yáñez Meza, Diego Armando

2017-01-01

En el presente artículo se evalúa la figura de la única instancia en la ley 1564/2012 o Código General del Proceso, con la finalidad de determinar si estos procesos son una infracción a la garantía constitucional del debido proceso y la doble instancia. Esta ley en sus artículos 17, 19 y 21, estableció la competencia de los jueces civiles municipales, civiles de circuito y de familia en procesos de única instancia, disposiciones que pueden constituirse como una infracción a la garantía proces...

Suicide risk in placebo-controlled studies of major depression

NARCIS (Netherlands)

Storosum, J. G.; van Zwieten, B. J.; van den Brink, W.; Gersons, B. P.; Broekmans, A. W.

2001-01-01

The purpose of this study was to determine if fear of an increased risk of attempted suicide in placebo groups participating in placebo-controlled studies is an argument against the performance of placebo-controlled trials in studies of major depression. All short-term and long-term,

Are Children the Better Placebo Analgesia Responders? An Experimental Approach.

Science.gov (United States)

Wrobel, Nathalie; Fadai, Tahmine; Sprenger, Christian; Hebebrand, Johannes; Wiech, Katja; Bingel, Ulrike

2015-10-01

There is little information regarding changes in placebo responsiveness with age, although first predictors of placebo responders such as psychological and physiological processes have been identified. Reviews and meta-analyses indicate that placebo response rates in randomized controlled trials (RCTs) are higher in children and adolescents compared with adults. As these studies cannot control for age-dependent differences in the natural course of the disease, biases might contribute to different placebo rates in RCTs. To avoid these biases, this study investigated age-related differences in placebo responsiveness between children and adults in a well-established experimental model of placebo analgesia combining classic conditioning and expectation. Our data confirm placebo analgesic responses in children, which did not differ in magnitude from those of adults. The influence of previous experience on subsequent treatment outcome was stronger in children than in adults, indicating an increased relevance of learning processes for treatment outcomes in children. Further studies are needed to understand the influence of treatment-related learning processes in children and adolescents, which might critically determine treatment responsiveness during adulthood. This study is the first to experimentally explore placebo analgesia and influences of previous experience on placebo responses in children compared with adults. We found comparable placebo responses in both groups and an increased relevance of learning processes for treatment outcomes in children. Copyright © 2015 American Pain Society. Published by Elsevier Inc. All rights reserved.

El Paleolítico Medio en el Cáucaso Meridional: la Cueva Doble (Valle de Tsutskhvati, República de Georgia

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Fernando DÍEZ MARTÍN

2010-08-01

Full Text Available El presente trabajo recoge los principales resultados derivados de la intervención arqueológica acometida entre los años 2002 y 2003 en el Valle de Tsutskhvati (República de Georgia, principalmente centrados en una nueva ronda de excavaciones en la Cueva Doble. Los estudios estratigráficos, tecnológicos, tafonómicos y polínicos permiten arrojar nuevos datos, complementarios a los obtenidos en la cercana cueva de Ortvale Klde, sobre las comunidades neandertales que habitaron la región del Cáucaso meridional, uno de los entornos geográficos en los que sobrevivieron los últimos representantes de esta especie. Mientras que los completos trabajos arqueológicos abordados en la cueva de Ortvale Klde han permitido contar con un amplio programa de datación para la presencia neandertal en dicha cavidad, el resto de los yacimientos del mismo periodo siguen presentando una cierta indefinición contextual. A pesar de ello, se acepta que la presencia neandertal en el valle de Tsutskhvati debió situarse en el mismo marco temporal que en Ortvale Klde. Aunque tanto la Cueva Doble, motivo de esta publicación, como la famosa Cueva del Bronce carecen hoy en día de contextos cronológicos fiables, es necesario señalar que estos yacimientos del valle de Tsutskhvati vienen siendo recurrentemente citados en el debate sobre el fin de los neandertales y la llegada de las primeras comunidades sapiens a la región caucásica. Es por ello por lo que la información novedosa aquí presentada (los últimos trabajos en Tsutskhvati se llevaron a cabo en la década de 1970 posee un indudable interés, a pesar de las limitaciones cronológicas, para ampliar nuestro conocimiento sobre este importante capítulo de la Prehistoria europea.

Placebo and antidepressant treatment for major depression

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Hougaard, Esben

2010-01-01

Antidepressant medication is generally considered the primary treatment for major depressive disorders (MDD), but antidepressant treatment has recently approached a crisis with shrinking specific effects and growing placebo responses in current trials. The aim of the paper is to review the placebo...

Are child and adolescent responses to placebo higher in major depression than in anxiety disorders? A systematic review of placebo-controlled trials.

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David Cohen

Full Text Available BACKGROUND: In a previous report, we hypothesized that responses to placebo were high in child and adolescent depression because of specific psychopathological factors associated with youth major depression. The purpose of this study was to compare the placebo response rates in pharmacological trials for major depressive disorder (MDD, obsessive compulsive disorder (OCD and other anxiety disorders (AD-non-OCD. METHODOLOGY AND PRINCIPAL FINDINGS: We reviewed the literature relevant to the use of psychotropic medication in children and adolescents with internalized disorders, restricting our review to double-blind studies including a placebo arm. Placebo response rates were pooled and compared according to diagnosis (MDD vs. OCD vs. AD-non-OCD, age (adolescent vs. child, and date of publication. From 1972 to 2007, we found 23 trials that evaluated the efficacy of psychotropic medication (mainly non-tricyclic antidepressants involving youth with MDD, 7 pertaining to youth with OCD, and 10 pertaining to youth with other anxiety disorders (N = 2533 patients in placebo arms. As hypothesized, the placebo response rate was significantly higher in studies on MDD, than in those examining OCD and AD-non-OCD (49.6% [range: 17-90%] vs. 31% [range: 4-41%] vs. 39.6% [range: 9-53], respectively, ANOVA F = 7.1, p = 0.002. Children showed a higher stable placebo response within all three diagnoses than adolescents, though this difference was not significant. Finally, no significant effects were found with respect to the year of publication. CONCLUSION: MDD in children and adolescents appears to be more responsive to placebo than other internalized conditions, which highlights differential psychopathology.

Placebo Response and Practice Effects in Schizophrenia Cognition Trials.

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Keefe, Richard S E; Davis, Vicki G; Harvey, Philip D; Atkins, Alexandra S; Haig, George M; Hagino, Owen; Marder, Stephen; Hilt, Dana C; Umbricht, Daniel

2017-08-01

Patients' previous experience with performance-based cognitive tests in clinical trials for cognitive impairment associated with schizophrenia can create practice-related improvements. Placebo-controlled trials for cognitive impairment associated with schizophrenia are at risk for these practice effects, which can be difficult to distinguish from placebo effects. To conduct a systematic evaluation of the magnitude of practice effects on the Measurement and Treatment Research to Improve Cognition in Schizophrenia Consensus Cognitive Battery (MCCB) in cognitive impairment associated with schizophrenia and to examine which demographic, clinical, and cognitive characteristics were associated with improvement in placebo conditions. A blinded review was conducted of data from 813 patients with schizophrenia who were treated with placebo in 12 randomized placebo-controlled clinical trials conducted mostly in outpatient clinics in North America, Europe, Asia, and Latin America from February 22, 2007, to March 1, 2014. A total of 779 patients provided data for the primary outcome measure at baseline and at least 1 follow-up. Seven trials had prebaseline assessments wherein the patients knew that they were not receiving treatment, allowing a comparison of practice and placebo effects in the same patients. Placebo compared with various experimental drug treatments. Composite score on the MCCB. Of the 813 patients in the study (260 women and 553 men; mean [SD] age, 41.2 [11.5] years), the mean MCCB composite score at baseline was 22.8 points below the normative mean, and the mean (SEM) total change in the MCCB during receipt of placebo was 1.8 (0.2) T-score points (95% CI, 1.40-2.18), equivalent to a change of 0.18 SD. Practice effects in the 7 studies in which there was a prebaseline assessment were essentially identical to the postbaseline placebo changes. Baseline factors associated with greater improvements in the MCCB during receipt of placebo included more depression

Effect of Blinding With a New Pragmatic Placebo Needle

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Liu, Baoyan; Xu, Huanfang; Ma, Rui; Mo, Qian; Yan, Shiyan; Liu, Zhishun

2014-01-01

Abstract Placebo control is a useful method for determining the efficacy of a therapy. In acupuncture researches, the preferred method for placebo control is acupuncture using a placebo needle that has a blunt tip and achieves no skin penetration. We performed a crossover study to validate the blinding effect of a new type of placebo needle. Sixty volunteers were randomized to receive acupuncture using 2 types of needles with different sequences: sequence AB, involving first the pragmatic placebo needle and then the real needle, and sequence BA, in a reverse order. Placebo acupuncture was performed by administering the placebo needle through an adhesive pad without skin penetration on the acupoints LI4, RN12, BL25, and BL36. Real acupuncture was performed by needling through the pad and penetrating the skin to 15 mm using a real needle on the same acupoints. The acupuncture was administered every other day with 3 sessions for 1 type of needle. The primary outcome was the perception of needle penetration. Besides degree of acupuncture pain, type, and degree of needle sensation, needle acceptability and factors influencing the subject blinding effect were assessed. Needle penetration was felt by 100%, 90% (54/60), 88.3% (53/60), and 95% (57/60) of volunteers receiving placebo acupuncture and 98.3% (59/60), 96.7% (58/60), 95% (57/60), and 95% (57/60) of volunteers receiving real acupuncture on LI4, RN12, BL25, and BL36, respectively. Differences of the volunteers’ perception of needle penetration between the placebo needle and real needle were not significant for the 4 acupoints (all P > 0.05). Volunteers experienced fewer distension sensations (P = 0.01), a lower degree of needle sensation (P = 0.007), and less pain (P = 0.006) during placebo acupuncture than during real acupuncture. The placebo needle was more easily accepted than the real needle (OR = 1.63, 95% CI, 1.01–2.64). The influences of age, sex, educational level, acupuncture

Laterality of pain: modulation by placebo and participants' paranormal belief.

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Klemenz, Caroline; Regard, Marianne; Brugger, Peter; Emch, Oliver

2009-09-01

To investigate the effects of placebo and paranormal belief on the laterality of pain perception. The right hemisphere is dominantly involved in both the mediation of pain sensation and the belief in paranormal phenomena. We set out to assess a possible influence of long-term belief systems on placebo analgesia in response to unilateral nociceptive stimuli. Forty healthy participants (20 high and 20 low believers as indexed by the Magical Ideation Scale) underwent a placebo analgesia study measuring stimulus detection, pain threshold, and pain tolerance by electrostimulation on the right and left hand. Placebo treatment consisted of the application of a sham cream on the hands. Placebo had a positive influence on pain perception in the 3 variables. Enhanced pain sensitivity for the left side was only found for the disbelievers. Placebo treatment resulted in a double dissociation: in believers, it increased tolerance exclusively on the left side, in disbelievers on the right side. Our results confirm laterality effects in pain perception. However, only disbelievers conformed to the expected higher left-sided sensitivity. Placebo effects were dissociated between believers and disbelievers suggesting that short-term reactions to a placebo are modulated by a person's long-term belief system.

Placebo prescription and empathy of the physician: A cross-sectional study.

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Braga-Simões, João; Costa, Patrício Soares; Yaphe, John

2017-12-01

Empathy in the patient-physician relationship is a major component in an effective placebo treatment, as in every medical treatment. Understanding the role of empathy of the physician in the placebo effect may help dissect some of the context variables responsible for the effectiveness of the placebo. To determine the frequency of placebo prescription, doctors' beliefs, motivation, and attitudes to placebos in general practice in northern Portugal and to test the association between placebo prescription and physician empathy. A cross-sectional study was conducted between November 2014 and January 2015 among general practice specialists and interns from 14 health centres in a northern Portuguese health region. The self-report questionnaire included the Portuguese version of the Jefferson scale of physician empathy (JSPE) and a questionnaire about placebo prescription. Associations between demographic variables, JSPE score, prescription of placebo, and the attitudes to placebo score were tested with the chi-squared statistic, student t-tests for independent samples, and Pearson correlation. The study included 93 general practitioners (GP) (response rate: 74%). Placebos were prescribed by 73% (n = 68) of the respondents. GPs who prescribe placebo are significantly younger (mean age = 38.4 years; SD = 11.1; t (90) = 2.98, P empathy scores (R = 0.310, P empathy from the prescriber, especially among younger GPs.

Biofeedback for anismus: has placebo effect been overlooked?

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Meagher; Sun; Kennedy; Smart; Lubowski

1999-03-01

Multiple uncontrolled studies have concluded that biofeedback is successful in treating anismus. This study's objective was to assess the physiological effects of placebo and biofeedback treatment on patients with anismus and to correlate changes with clinical improvement. Twelve patients with symptoms and electrophysiological findings of anismus were studied. Initial assessment included a detailed history, symptom assessment by linear analogue scales, anorectal manometric and electrophysiological studies, colon transit scintigraphy, and scintigraphic proctography. Patients underwent 5 days of placebo treatment, followed 1 week later by re-assessment of symptoms and physiological studies. Five days of biofeedback was then given followed by another complete re-assessment 1 week later. A final interview was performed 2 months later. All assessments were by an independent observer who was not responsible for the treatments. Seven patients reported an overall improvement in symptoms following placebo treatment. A total of seven patients reported improvement following biofeedback, three of whom had already reported an improvement with placebo. One patient who reported improvement following placebo had worsening of symptoms following biofeedback. The only symptoms or tests which changed more with biofeedback than placebo were anal pressure and electromyographic activity on attempted defaecation in the left lateral position. There was no demonstrable correlation between change in symptoms and change in physiological tests. The scintigraphic 'ejection fraction' of the rectum was unchanged by treatment. Clinical improvement in previous studies may in part be due to placebo effect and observer bias. Improvement with biofeedback may be due to physiological changes which are not detected with conventional anorectal physiological tests.

Implicit versus explicit associative learning and experimentally induced placebo hypoalgesia

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Andrea L Martin-Pichora

2011-03-01

Full Text Available Andrea L Martin-Pichora1,2, Tsipora D. Mankovsky-Arnold3, Joel Katz11Department of Psychology, York University, Toronto, ON, Canada; 2Centre for Student Development and Counseling, Ryerson University, Toronto, ON, Canada; 3Department of Psychology, McGill University, Montreal, QC, CanadaAbstract: The present study examined whether 1 placebo hypoalgesia can be generated through implicit associative learning (ie, conditioning in the absence of conscious awareness and 2 the magnitude of placebo hypoalgesia changes when expectations about pain are made explicit. The temperature of heat pain stimuli was surreptitiously lowered during conditioning trials for the placebo cream and the magnitude of the placebo effect was assessed during a subsequent set of trials when the temperature was the same for both placebo and control conditions. To assess whether placebo hypoalgesia could be generated from an implicit tactile stimulus, a 2 × 2 design was used with direction of cream application as one factor and verbal information about which cream was being applied as the second factor. A significant placebo effect was observed when participants received verbal information about which cream was being applied but not following implicit conditioning alone. However, 87.5% of those who showed a placebo response as the result of implicit conditioning were able to accurately guess the order of cream application during the final trial, despite a lack of awareness about the sensory manipulation and low confidence in their ratings, suggesting implicit learning in some participants. In summary, implicit associative learning was evident in some participants but it was not sufficient to produce a placebo effect suggesting some level of explicit expectation or cognitive mediation may be necessary. Notably, the placebo response was abolished when expectations were made explicit, suggesting a delicate interplay between attention and expectation.Keywords: placebo hypoalgesia

El ejercicio físico aeróbico incrementa la vasodilatación dependiente del endotelio y el consumo de oxígeno de mujeres primigestantes saludables. Ensayo clínico controlado, aleatorizado. NCT00741312

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Róbinson Ramírez-Vélez, Ft., PhD.(c

2010-11-01

Conclusión: La práctica regular de ejercicio aeróbico y controlado, mejora la función endotelial y la capacidad física en mujeres gestantes. Por esta razón, intervenciones como esta podrían ser una alternativa temprana y efectiva para fortalecer la prevención de patologías durante el embarazo asociadas con disfunción endotelial.

Motivation and expectancy influences in placebo responding: the mediating role of attention.

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Aigner, Carrie; Svanum, Soren

2014-12-01

Drawing upon research in perception and motivation, the current study proposes a motivation-attention model of placebo in which more motivated persons pay greater attention to placebo-related stimuli, directly influencing placebo response. We manipulated both motivation to respond to placebo and expectations of placebo response in a 2 × 2 design. Participants (N = 152) evaluated a series of placebo pheromones (slightly scented water) of potential romantic dates and made desirability ratings. Consistent with hypotheses, more highly motivated participants demonstrated greater placebo responses, as evidenced by higher desirability ratings of the "pheromone" and greater variability among ratings, when compared to less motivated participants. Moreover, the relation between motivation and placebo response was mediated by attention. Contrary to expectations, we found no effect for expectancy. These findings highlight the importance of motivation and the mediating factor of attention in placebo and support goal-oriented models of placebo. © 2014 International Union of Psychological Science.

Investigación en especialidades quirúrgicas Surgical Research

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Juan Viñas Salas

2004-03-01

Full Text Available En este artículo los autores revisan las características específicas de la investigación en las especialidades quirúrgicas, sus problemas y diferencias en relación al resto de la investigación biomédica. Hacen especial hincapié en los temas más frecuentes a investigar en cirugía, sus defectos y la metodología. Argumentan que los estudios prospectivos randomizados a doble ciego no deben ser sobredimensionados, ya que presentan problemas metodológicos y bioéticos al aplicarlos a la cirugía. Los estudios prospectivos son los más utilizados por los cirujanos para el avance de las especialidades quirúrgicas.In this article authors review the specific characteristics of surgical research. Its problems and differences from other biomedical research. Specially they specify the main topics for surgical investigation, its pitfalls and methodologies. They argue that randomised prospective double blind studies must not be over dimensioned, as for surgery they present many difficulties, specially ethical and practical. Prospective studies are been more used by surgeons for the advance of the different surgical specialities.

[Placebo-controlled trials in schizophrenia].

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Melamed, Yuval; Davidson, Michael; Bleich, Avi

2004-03-01

Clinical trials involving human subjects give rise to ethical and medico-legal dilemmas. Essential research of new drugs may potentially expose patients to ineffective medications or to placebo. The complexity of the problem increases when dealing with mentally ill patients, for whom, on the one hand there is no known cure for their disease, and on the other hand, it is sometimes questionable whether or not they are able to provide informed consent to participate in clinical trials. The Israel Psychiatric Association decided to develop a position paper on the subject of placebo-controlled clinical trials in schizophrenia patients. Discussion groups were established, and the available material in the professional literature was examined, with an emphasis on recent developments. The Declaration of Helsinki and its amendments were analyzed, and experts in the field were consulted. Clinical drug trials for development of new medications are essential in all fields of medicine, especially in psychiatry. The requirement for a placebo arm in pharmaceutical trials presents ethical and clinical dilemmas that are especially complicated with regard to mentally ill persons whose free choice and ability to provide informed consent may be questionable. However, we do not believe that this predicament justifies unconditional rejection of placebo use in psychiatry, when it may provide substantial benefit for some patients. Simultaneously, it is our duty to provide stringent restrictions that will enable strict supervision over the scientific, clinical and ethical aspects of the trials. We propose the following criteria for approval of pharmaceutical trials that include a placebo arm: scientific justification; clinical and ethical justification; provision of informed consent; recruitment of patients hospitalized voluntarily; prevention of harm; administration of additional potential therapeutic interventions; benefit to patients participating in the study; control and follow

Revisión de la técnica de doble torsión y del método experimental en materiales cerámicos

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de Aza, A. H.

2001-04-01

Full Text Available The double torsion test configuration has many advantages for the evaluation of subcritical crack growth parameters and fracture toughness. These advantages are: crack-length independence, four-point loading, simple specimen geometry and ease of precraking. However , a number of unresolved questions need to be answered about the double torsion specimen and experimental techniques involved in its use before this testing can be adopted as a standard. In this paper these questions are addressed, the analyses of the compliance and KI for the double torsion configuration are revised, and the load relaxation test in double torsion is examined in order to define the conditions under which de data are valid.

La técnica de doble torsión tiene numerosas ventajas a la hora de evaluar el crecimiento subcritico de grieta en un material cerámico. Estas ventajas, entre otras, son: independencia del factor de intensidad de tensiones, KI, con respecto a la longitud de grieta, configuración de carga en cuatro puntos y facilidad de prefisuracion. Sin embargo, aun hoy en día, algunas preguntas sobre esta técnica quedan sin respuesta. En el presente trabajo se hace referencia a estas cuestiones, se revisan las expresiones analíticas de la flexibilidad y el factor de intensidad de tensiones, KI, propuestas en la literatura científica para la configuración particular de la doble torsión, y se examina el método de trabajo experimental, ensayo de relajación de carga, tratando de definir las condiciones en las cuales los datos obtenidos son validos.

A publicação de dados governamentais abertos: proposta de revisão da classe sobre Previdência Social do Vocabulário Controlado do Governo Eletrônico

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Cláudio José Silva Ribeiro

Full Text Available Este trabalho analisa a classe sobre Previdência Social do Vocabulário Controlado do Governo Eletrônico, investigando a publicação de dados governamentais abertos, realizada pela Empresa de Tecnologia e Informações da Previdência Social. Trata-se de um estudo exploratório, com objetivo de propor a revisão da classe sobre Previdência Social no domínio do Governo Eletrônico brasileiro, a fim de ampliar e corrigir a representação da área. O trabalho utiliza como metodologia: (1 pesquisa bibliográfica, para fundamentação teórica; (2 seleção da classe de assunto sobre Previdência Social do Vocabulário Controlado do Governo Eletrônico, como recorte; (3 análise dos pontos relacionados à categorização, linguagem escolhida (natural ou artificial, cobertura dos termos pertencentes ao escopo da classe de assunto estudado e relações apresentadas entre os termos; (4 propostas para revisão da classe estudada. O estudo aponta, nos resultados, falhas estruturais e inconsistências conceituais localizados no vocabulário. Discute a necessidade de se utilizarem vocabulários consistentes para representação dos dados publicados, a fim de torná-los legíveis por máquina e compartilháveis entre aplicações de software. Afirma que se deve investir em vocabulários já existentes para evitar esforços com a criação de outros instrumentos de representação. Julga necessário que outros órgãos públicos, além da Empresa de Tecnologia e Informações da Previdência Social, interessem-se em analisar e propor alterações e atualizações nas classes cuja temática contemple os dados por eles geridos. Conclui que a utilização do Vocabulário Controlado do Governo Eletrônico pode ir além de um mapa para navegação em páginas eletrônicas do setor público brasileiro, constituindo instrumento dinâmico de organização do conhecimento, podendo ser utilizado para diversos fins, de acordo com os interesses de cada usuário.

Metodología del cálculo directo de la estructura principal de un petrolero de doble casco mediante la aplicación de un programa de elementos finitos

OpenAIRE

Bustos Pérez, Alfonso

2011-01-01

Analizar el procedimiento de cálculo de la estructura de un buque petrolero de doble casco realizado empleando un programa de cálculo de estructuras de acuerdo con: Las reglas de construcción de la Asociación Internacional de Sociedades de Clasificación (IACS). Los procedimientos de cálculo directo, en concreto el método de elementos finitos. Escuela Técnica Superior de Ingeniería Naval y Oceánica

Energyhealing and the placebo-effect

DEFF Research Database (Denmark)

Ostenfeld-Rosenthal, Ann

2012-01-01

and the placebo effect? From a phenomenological perspective and with a point of departure in MUS (medically unexplained symptoms) patients’ experiences of ‘bodily-lived-meaning’ in Danish healing rituals I try to develop an understanding of how bodily experienced images of body and self work to transform...... the patient during a healing ritual, of the process of a bodily founded symbolic ‘re-editing’ of body- and self-image, which I argue is a fundamental art in healing rituals. In conclusion I argue that the placebo is nothing but the effectiveness of bodily sensed symbols....

Can pill placebo augment cognitive-behavior therapy for panic disorder?

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Churchill Rachel

2007-12-01

Full Text Available Abstract Background In a number of drug and psychotherapy comparative trials, psychotherapy-placebo combination has been assumed to represent psychotherapy. Whether psychotherapy plus pill placebo is the same as psychotherapy alone is an empirical question which however has to date never been examined systematically. Methods We conducted a systematic review and meta-analysis of randomised controlled trials (RCTs that directly compared cognitive-behavior therapy (CBT alone against CBT plus pill placebo in the treatment of panic disorder. Results Extensive literature search was able to identify three relevant RCTs. At the end of the acute phase treatment, patients who received CBT plus placebo had 26% (95%CI: 2 to 55% increased chances of responding than those who received CBT alone. At follow-up the difference was no longer statistically significant (22%, 95%CI: -10% to 64%. Conclusion The act of taking a pill placebo may enhance the placebo effect already contained in the effective psychotherapeutic intervention during the acute phase treatment. Theoretically this is an argument against the recently claimed null hypothesis of placebo effect in general and clinically it may point to some further room for enhancing the psychotherapeutic approach for panic disorder.

Placebo Acupuncture Devices: Considerations for Acupuncture Research

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Dan Zhu

2013-01-01

Full Text Available Determining an appropriate control for use in acupuncture research remains one of the largest methodological challenges acupuncture researchers face. In general, acupuncture controls fall under one of two categories: (1 sham acupuncture, in which the skin is punctured with real acupuncture needles either fully at nonacupoint locations or shallowly at acupoint locations or both and (2 placebo acupuncture, which utilizes nonpenetrating acupuncture devices. In this study, we will focus on non-penetrating placebo acupuncture devices (blunted-needle and nonneedle devices that are currently available in acupuncture research. We will describe each device and discuss each device’s validation and application in previous studies. In addition, we will outline the advantages and disadvantages of these devices and highlight how the differences among placebo devices can be used to isolate distinct components of acupuncture treatment and investigate their effects. We would like to emphasize that there is no single placebo device that can serve as the best control for all acupuncture studies; the choice of an acupuncture control should be determined by the specific aim of the study.

Placebo and nocebo effects on itch: effects, mechanisms, and predictors

NARCIS (Netherlands)

Bartels, D.J.P.; Laarhoven, A.I. van; Kerkhof, P.C. van de; Evers, A.W.

2016-01-01

Placebo and nocebo effects have been extensively studied in the field of pain and more recently also on itch. In accordance with placebo research on pain, expectancy learning via verbal suggestion or conditioning has shown to induce placebo and nocebo effects on itch, in which the combination of

Osteoarthritis treatment using autologous conditioned serum after placebo

NARCIS (Netherlands)

Rutgers, Marijn; Creemers, Laura B; Auw Yang, Kiem Gie; Raijmakers, Natasja J H; Dhert, Wouter J A; Saris, Daniel B F

BACKGROUND AND PURPOSE: Autologous conditioned serum (ACS) is a disease-modifying drug for treatment of knee osteoarthritis, and modest superiority over placebo was reported in an earlier randomized controlled trial (RCT). We hypothesized that when given the opportunity, placebo-treated patients

Identificación e implementación de paquetes tecnológicos en ganadería vacuna de doble propósito: Caso Manabí-Ecuador

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Torres, Yenny; Rivas, José; De Pablos-Heredero, Carmen; Perea, José; Toro-Mujica, Paula; Angón, Elena; García, Antón

2014-01-01

El avance en los sistemas ganaderos se asocia a la implementación de tecnologías en la producción y a la mejora de sus ingresos. El objetivo del presente estudio fue la identificación e implementación de paquetes tecnológicos y su relación con los resultados productivos en vacuno de doble propósito de la provincia de Manabí, Ecuador en dos zonas climáticas: el Bosque seco tropical y el húmedo tropical. Se agrupan 25 tecnologías en seis paquetes tecnológicos (PT) seleccionadas mediante una met...

Mamoplastia de aumento en doble plano: una alternativa subfascial en la optimización de las indicaciones Breast augmentation in dual plane: a subfascial alternative towards optimizing indications

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O. D. Ventura

2008-12-01

Full Text Available Proponemos el Doble Plano en la cirugía de aumento mamario como una alternativa a las indicaciones de uso del plano subfascial. Presentamos 30 casos en los que se utilizan variantes de la técnica en doble plano y discutimos sus indicaciones y ventajas a la vez que describimos detalles de la técnica. Este método consiste en crear un bolsillo donde el implante queda cubierto por el músculo pectoral solamente en su tercio superior y por la fascia en el resto. Las proporciones de estos componentes se ajustan según las características anatómicas de cada caso. Las indicaciones de la técnica son las mamoplastias primarias, y más específicamente, las secundarias con ptosis, encapsulamiento o ripling.We propose Dual Plane tecnique in augmentative mammoplasty as an alternative for individual adjustment when using the subfascial plane. Thirty cases are presented in which a variation of the dual plane technique is used. Its indications, advantages and surgical highpoints are discussed. This method consists on a pocket where the implant is covered by the pectoral muscle only on its upper pole, and by the fascia on the rest of it. The percentages of this components are adjusted to the anatomical characteristics of each case. Indications of this technique are primary mammoplasties, and more precisely secondary ones with ptosis, contractile capsule or ripling.

A brief history of placebos and clinical trials in psychiatry.

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Shorter, Edward

2011-04-01

The history of placebos in psychiatry can be understood only in the context of randomized controlled trials (RCTs). Placebo treatments are as old as medicine itself, and are particularly effective in dealing with psychosomatic symptoms. In psychiatry, placebos have mainly been featured in clinical drug trials. The earliest controlled trial in psychiatry (not involving drugs) occurred in 1922, followed by the first crossover studies during the 1930s. Meanwhile the concept of randomization was developed during the interwar years by British statistician Ronald A Fisher, and introduced in 3 trials of tuberculosis drugs between 1947 and 1951. These classic studies established the RCT as the gold standard in pharmaceutical trials, and its status was cemented during the mid-1950s. Nevertheless, while the placebo became established as a standard measure of drug action, placebo treatments became stigmatized as unethical. This is unfortunate, as they constitute one of the most powerful therapies in psychiatry. In recent years, moreover, the dogma of the placebo-controlled trial as the only acceptable data for drug licensing is also being increasingly discredited. This backlash has had 2 sources: one is the recognition that the US Food and Drug Administration has been too lax in permitting trials controlled with placebos alone, rather than also using an active agent as a test of comparative efficacy. In addition, there is evidence that in the hands of the pharmaceutical industry, the scientific integrity of RCTs themselves has been degraded into a marketing device. The once-powerful placebo is thus threatened with extinction.

Placebo and nocebo effects in itch and pain

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Evers, A.W.M.; Bartels, D.J.P.; Laarhoven, A.I.M. van

2014-01-01

Physical complaints, such as pain, can be effectively altered by placebo and nocebo effects due to induction of positive or negative expectations. While verbal suggestion and conditioning are recognized as playing a key role in placebo and nocebo effects on pain, these mechanisms have barely been

EFECTO DE LA EPOCA DEL PARTO Y DEL SISTEMA DE AMAMANTAMIENTO SOBRE LA EFICIENCIA REPRODUCTIVA DE VACAS DEL SISTEMA DOBLE PROPÓSITO

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*Roger Salgado

2003-12-01

Full Text Available Se evaluó el efecto de la época del parto y el sistema de amamantamiento en la eficiencia reproductiva postparto devacas manejadas bajo el sistema de doble propósito en una finca ubicada en el municipio de Chinú Departamento decórdoba. Se utilizaron 60 vacas multíparas homogéneas en el número de partos, producción de leche, manejo, sanidad,ambiente y alimentación. Se distribuyeron en cuatro tratamientos utilizando un diseño completamente al azar, con unarreglo factorial 2x2 con dos épocas (sequía y lluvia y dos sistemas de amamantamiento (tradicional y restringido con 15repeticiones por grupo experimental: T1 – Sequía x tradicional – T2 – sequía x restringido - T3 – Lluvia x tradicional – T4– Lluvia x restringido. La época no tuvo efecto (P>0.05 sobre la tasa de gestación (50% para la época seca vs 40% parala época de lluvia ni los días abiertos (132.13 + 65.35 vs 138.71 + 60.21 para la época de sequía y lluvia respectivamente.Se encontró un efecto del amamantamiento sobre la tasa de gestación y los días abiertos (P<0.05, siendo mayorpara el amamantamiento restringido (70% y 109.00 + 52.93 días comparado con el tradicional (20% y 161.87 + 60.14días. Por otra parte, se determinó un efecto en la frecuencia acumulada de días abiertos, hallándose los mejoresresultados en los tratamientos T2 y T4 (P<0.016. El estudio permitió concluir que el amamantamiento reduce elanestro postparto y mejora la eficiencia reproductiva en bovinos manejados bajo el sistema de doble propósito.

Reviving the old sermon of medicine with the placebo effect

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Cho Hyong Jin

2005-01-01

Full Text Available OBJECTIVE: The message of the importance of a caring doctor-patient relationship is now like an old sermon which does not impact anyone's mind or action. Observing the healing practice of the old time physicians, who valued their attitudes and relationship with their patients more than the actual interventions, this paper reviews the literature on their main therapeutic device - the placebo effect - as a novel way of delivering this old sermon of medicine to contemporary doctors. DISCUSSION: There are countless historical and contemporary examples of the impressive placebo effect and although contested by some, it seems real and significant. The classic conditioning theory and the expectation theory explain reasonably well the mechanisms of the placebo effect, especially in conjunction with each other. The underlying biochemical pathway, according to the limited current knowledge, involves endorphins for pain and dopamine for Parkinson's disease. Finally, human factors such as the doctor's positive attitudes and a good doctor-patient relationship seem to be more essential than the placebo itself in eliciting the placebo effect. CONCLUSIONS: Given the body of evidence supporting the existence of significant placebo effect and the importance of the doctor-patient relationship in determining it, the human factors of the medical treatment should be emphasised in order to maximise the placebo effect and consequently the overall therapeutic effect of the healing acts.

Black Sigatoka (Mycosphaerella fijiensis Morelet and food security. Bio-climate Scenarios in bananas under the effect of climate change in Ciego de Avila, Cuba

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Hernández-Mansilla Alexis Augusto

2016-11-01

Full Text Available The negative evidence of climate change of high importance for the future agricultural production and the need of food sovereignty and security, impose to develop research to predict the phenology of plants and their pests, mainly those of economic importance. The aim of this work is to interpret the epidemiological behavior of the black Sigatoka disease (Mycosphaerella fijiensis Morelet in banana for the years 2020 and 2025 under the effects of climate change in Ciego de Avila. There were made bioclimatic scenarios using daily data of maximum temperature, minimum temperature and accumulated rainfall of 14 days generated by the Regional Climatic Model "PRECIS Caribbean" with boundary conditions of the global model ECHAM - 4 for future climate projections under scenarios of emission A2 and B2. The key indicators of this disease: "Sum of Speed ​​" and the "Evolution state" of 4 leaves were obtained. The results show Sums speeds above 11000 thermo-physiological units, as well as a continuous and progressive increase in the "Evolution State" with values above 500 units during the analyzed years. We infers will occur an increase in the number of treatments and the plant protection cost, which implies the need to draw integrated management measures that include agro-ecological principles, search for resistant varieties to replace those susceptible to the disease that are currently used and strengthen the climate change adaptation and the resilience in the agricultural ecosystem.

Attitudes Toward Placebo Use in Lebanon.

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Abou-Mrad, Fadi; Tarabey, Lubna

2015-05-01

Placebo use, both in clinical trials and patient care, is a problematic ethical issue surrounded by opposing arguments from those who advocate its use versus those who do not. This problematic aspect of placebo is more challenging in Lebanon where religious ideologies dominate people's beliefs, and where laws that guide medical care are vague. This paper aims to highlight the cultural ideologies that dominate medical care and the perspectives of people associated with the field. The method relied on semi-structured interviews with religious leaders, representatives of society and healthcare professionals. Panel discussions incorporating healthcare professionals, academics, scientists and medical researchers were also organized. The legal environment in Lebanon is characterized by lack of an appropriate legislative guideline that categorically clarifies the value of the human person in medical care. There is a lack of a common ethical standard within a society characterized by social and political dissent. The culturally upheld principles and actual application of the principles of ethics surrounding patient autonomy were overviewed. Medical practitioners failed to agree to a general outline that should guide the use of placebo where it became evident that each practitioner adopted a subjective framework which ultimately undermines patient autonomy. The paper proposes that until a new legislative code that clarifies ethical principles properly guiding medical care is coined, the process of placebo use will continue to be subject to the paternalistic assessments of medical professionals. Copyright © 2015 Elsevier HS Journals, Inc. All rights reserved.

Is placebo useful in the treatment of major depression in clinical practice?

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Marchesi C

2013-06-01

Full Text Available Carlo Marchesi, Chiara De Panfilis, Matteo Tonna, Paolo Ossola University of Parma, Department of Neuroscience, Psychiatric Unit, Parma, Italy Background: For many years, placebo has been defined by its inert content and use in clinical trials. In recent years, several studies have demonstrated its effect in the treatment of major depression. The aim of this paper is to present the conclusions of recent meta-analyses of the placebo effect in major depression, to explain the mechanism by which placebo exerts its effect, and to discuss whether placebo can be used in the treatment of patients with major depression in clinical practice. Recent meta-analyses have demonstrated that the placebo effect is estimated to account for 67% of the treatment effect in patients receiving antidepressants, and furthermore that placebo is as effective as antidepressants in patients with mild to moderate major depression (reporting a Hamilton Depression Rating Scale score lower than 25, whereas placebo is less effective than antidepressants in severely depressed patients. However, several limitations make the translation of these conclusions into clinical practice impracticable. Clinicians should learn from the "placebo lesson" to maximize the nonspecific effects of treatment when they prescribe an antidepressant, particularly in less severely depressed patients, who show a higher placebo response in randomized controlled trials. This strategy can increase the antidepressant effect and may reduce nonadherence with treatment. Keywords: placebo effect, major depressive disorder, subthreshold depressive disorder, antidepressants

Confusing placebo effect with natural history in epilepsy: A big data approach.

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Goldenholz, Daniel M; Moss, Robert; Scott, Jonathan; Auh, Sungyoung; Theodore, William H

2015-09-01

For unknown reasons, placebos reduce seizures in clinical trials in many patients. It is also unclear why some drugs showing statistical superiority to placebo in one trial may fail to do so in another. Using Seizuretracker.com, a patient-centered database of 684,825 seizures, we simulated "placebo" and "drug" trials. These simulations were employed to clarify the sources of placebo effects in epilepsy, and to identify methods of diminishing placebo effects. Simulation 1 included 9 trials with a 6-week baseline and 6-week test period, starting at time 0, 3, 6…24 months. Here, "placebo" reduced seizures regardless of study start time. Regression-to-the-mean persisted only for 3 to 6 months. Simulation 2 comprised a 6-week baseline and then 2 years of follow-up. Seizure frequencies continued to improve throughout follow-up. Although the group improved, individuals switched from improvement to worsening and back. Simulation 3 involved a placebo-controlled "drug" trial, to explore methods of placebo response reduction. An efficacious "drug" failed to demonstrate a significant effect compared with "placebo" (p = 0.12), although modifications either in study start time (p = 0.025) or baseline population reduction (p = 0.0028) allowed the drug to achieve a statistically significant effect compared with placebo. In epilepsy clinical trials, some seizure reduction traditionally attributed to placebo effect may reflect the natural course of the disease itself. Understanding these dynamics will allow future investigations into optimal clinical trial design and may lead to identification of more effective therapies. Ann Neurol 2015;78:329-336. © 2015 American Neurological Association.

Does different information disclosure on placebo control affect blinding and trial outcomes? A case study of participant information leaflets of randomized placebo-controlled trials of acupuncture

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Soyeon Cheon

2018-01-01

Full Text Available Abstract Background While full disclosure of information on placebo control in participant information leaflets (PILs in a clinical trial is ethically required during informed consent, there have been concerning voices such complete disclosures may increase unnecessary nocebo responses, breach double-blind designs, and/or affect direction of trial outcomes. Taking an example of acupuncture studies, we aimed to examine what participants are told about placebo controls in randomized, placebo-controlled trials, and how it may affect blinding and trial outcomes. Methods Authors of published randomized, placebo-controlled trials of acupuncture were identified from PubMed search and invited to provide PILs for their trials. The collected PILs were subjected to content analysis and categorized based on degree of information disclosure on placebo. Blinding index (BI as a chance-corrected measurement of blinding was calculated and its association with different information disclosure was examined. The impact of different information disclosure from PILs on primary outcomes was estimated using a random effects model. Results In 65 collected PILs, approximately 57% of trials fully informed the participants of placebo control, i.e. full disclosure, while the rest gave deceitful or no information on placebo, i.e. no disclosure. Placebo groups in the studies with no disclosure tended to make more opposite guesses on the type of received intervention than those with disclosure, which may reflect wishful thinking (BI −0.21 vs. −0.16; p = 0.38. In outcome analysis, studies with no disclosure significantly favored acupuncture than those with full disclosure (standardized mean difference − 0.43 vs. −0.12; p = 0.03, probably due to enhanced expectations. Conclusions How participants are told about placebos can be another potential factor that may influence participant blinding and study outcomes by possibly modulating patient expectation. As we

Experimental Cardiac Arrest Treatment with Adrenaline, Vasopressin, or Placebo

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Palácio, Manoel Ângelo Gomes; de Paiva, Edison Ferreira; de Azevedo, Luciano Cesar Pontes; Timerman, Ari

2013-01-01

Background The effect of vasoconstrictors in prolonged cardiopulmonary resuscitation (CPR) has not been fully clarified. Objectives To evaluate adrenaline and vasopressin pressure effect, and observe the return of spontaneous circulation (ROSC). Methods A prospective, randomized, blinded, and placebo-controlled study. After seven minutes of untreated ventricular fibrillation, pigs received two minutes cycles of CPR. Defibrillation was attempted (4 J/kg) once at 9 minutes, and after every cycle if a shockable rhythm was present, after what CPR was immediately resumed. At 9 minutes and every five minutes intervals, 0.02 mg/kg (n = 12 pigs) adrenaline, or 0.4 U/kg (n = 12) vasopressin, or 0.2 mL/kg (n = 8) 0.9% saline solution was administered. CPR continued for 30 minutes or until the ROSC. Results Coronary perfusion pressure increased to about 20 mmHg in the three groups. Following vasoconstrictors doses, pressure level reached 35 mmHg versus 15 mmHg with placebo (p adrenaline or placebo. ROSC rate differed (p = 0.031) among adrenaline (10/12), vasopressin (6/12), and placebo (2/8). Time-to-ROSC did not differ (16 minutes), nor the number of doses previously received (one or two). There was no difference between vasoconstrictors, but against placebo, only adrenaline significantly increased the ROSC rate (p = 0.019). Conclusion The vasoconstrictors initial pressure effect was equivalent and vasopressin maintained a late effect at prolonged resuscitation. Nevertheless, when compared with placebo, only adrenaline significantly increased the ROSC rate. PMID:24173134

Should we reconsider the routine use of placebo controls in clinical research?

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Avins Andrew L

2012-04-01

Full Text Available Abstract Background Modern clinical-research practice favors placebo controls over usual-care controls whenever a credible placebo exists. An unrecognized consequence of this preference is that clinicians are more limited in their ability to provide the benefits of the non-specific healing effects of placebos in clinical practice. Methods We examined the issues in choosing between placebo and usual-care controls. We considered why placebo controls place constraints on clinicians and the trade-offs involved in the choice of control groups. Results We find that, for certain studies, investigators should consider usual-care controls, even if an adequate placebo is available. Employing usual-care controls would be of greatest value for pragmatic trials evaluating treatments to improve clinical care and for which threats to internal validity can be adequately managed without a placebo-control condition. Conclusions Intentionally choosing usual-care controls, even when a satisfactory placebo exists, would allow clinicians to capture the value of non-specific therapeutic benefits that are common to all interventions. The result could be more effective, patient-centered care that makes the best use of both specific and non-specific benefits of medical interventions.

Should we reconsider the routine use of placebo controls in clinical research?

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Avins, Andrew L; Cherkin, Daniel C; Sherman, Karen J; Goldberg, Harley; Pressman, Alice

2012-04-27

Modern clinical-research practice favors placebo controls over usual-care controls whenever a credible placebo exists. An unrecognized consequence of this preference is that clinicians are more limited in their ability to provide the benefits of the non-specific healing effects of placebos in clinical practice. We examined the issues in choosing between placebo and usual-care controls. We considered why placebo controls place constraints on clinicians and the trade-offs involved in the choice of control groups. We find that, for certain studies, investigators should consider usual-care controls, even if an adequate placebo is available. Employing usual-care controls would be of greatest value for pragmatic trials evaluating treatments to improve clinical care and for which threats to internal validity can be adequately managed without a placebo-control condition. Intentionally choosing usual-care controls, even when a satisfactory placebo exists, would allow clinicians to capture the value of non-specific therapeutic benefits that are common to all interventions. The result could be more effective, patient-centered care that makes the best use of both specific and non-specific benefits of medical interventions.

Identificación e implementación de paquetes tecnológicos en ganadería vacuna de doble propósito. Caso Manabí-Ecuador

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Yenny Torres; José Rivas; Carmen De Pablos-Heredero; José Perea; Paula Toro-Mujica; Elena Angón; Antón García García

2014-01-01

El avance en los sistemas ganaderos se asocia a la implementación de tecnologías en la producción y a la mejora de sus ingresos. El objetivo del presente estudio fue la identificación e implementación de paquetes te cnológicos y su relación con los resultados productivos en vacuno de doble propósito de la provincia de Manabí, Ecua dor en dos zonas climáticas: el Bosque seco tropical y el húmedo tropical. Se agrupan 25 tecnologías en seis paquetes tecnológicos (PT) seleccionadas mediante una m...

Transculturación y la diferencia colonial. Doble traducción

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Freya Schiwy

2007-01-01

Full Text Available En el marco del concepto wallersteineano de sistema mundo moderno/colonial –como fue modificado por Mignolo (2000- los autores abordan el problema de la traducción/transculturación. Misioneros y antropólogos en África, Asia y Mesoamérica solían realizar traducciones unidireccionales determinadas por los intereses metropolitanos con el fin de propiciar la asimilación y la conversión. La traducción fue, ciertamente, el proceso por el cual la colonialidad del poder articuló la diferencia cultural. Pero complejos mecanismos de reciprocidad, como el “translengüeo” podrían operar con el objetivo de trasladar conocimiento, emociones o memorias desde las cosmologías amerindias o subalternas a través del español o cualquier otro idioma colonial, como los Zapatistas han llevado a cabo. Para el subcomandante Marcos, la traducción no es meramente interlingüística sino también intercosmológica. Los autores proponen varios ejemplos de traducción/transculturación entre español y Tojolabal o Aymara para mostrar ese complejo y doble movimiento.In the frame of the Wallersteinean concept of modern/colonial world system –as modified by Mignolo (2000- the authors address the topic of translation/transculturation. Missionaries and anthropologists in Africa, Asia and Mesoamerica used to make one-way translations determined by metropolitan interests for the purposes of assimilation and conversion. Translation was indeed the process wherein the coloniality of power articulated the colonial difference. But complex mechanisms of reciprocity, as translanguaging, could operate in order to convey knowledge, emotions or memories from Amerindian or subaltern cosmologies through Spanish or any other colonial languages as the Zapatistas have performed. For “subcomandante” Marcos, translation is not merely interlinguistic but also intercosmological. The authors go through several examples of translation/transculturation between Spanish and

Use of Placebo in Supplementation Studies—Vitamin D Research Illustrates an Ethical Quandary

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Leigh A. Frame

2018-03-01

Full Text Available History has shown that without explicit and enforced guidelines, even well-intentioned researchers can fail to adequately examine the ethical pros and cons of study design choices. One area in which consensus does not yet exist is the use of placebo groups in vitamin supplementation studies. As a prime example, we focus on vitamin D research. We aim to provide an overview of the ethical issues in placebo-controlled studies and guide future discussion about the ethical use of placebo groups. Research in the field of vitamin D shows variation in how placebo groups are used. We outline four types of control groups in use: active-control, placebo-control with restrictions on supplementation, placebo-control without supplementation restrictions, and placebo-control with rescue repletion therapy. The first two types highlight discrete ethical issues: active-control trials limit the ability to detect a difference; placebo-control trials that restrict supplementation potentially place subjects at risk of undue harm. The final two, placebo-control without supplementation restrictions or with rescue repletion therapy, offer potential solutions to these ethical challenges. Building on this, guidelines should be established and enforced on the use of placebo in supplementation studies. Furthermore, the field of vitamin D research has the potential to set an example worthy of emulation.

Intravenous dexketoprofen vs placebo for migraine attack in the emergency department: A randomized, placebo-controlled trial.

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Gungor, Faruk; Akyol, Kamil Can; Kesapli, Mustafa; Celik, Ahmet; Karaca, Adeviye; Bozdemir, Mehmet Nuri; Eken, Cenker

2016-02-01

Migraine is a leading headache etiology that frequently presents to the emergency department (ED). In the present study, we aimed to determine the efficacy of dexketoprofen in aborting migraine headaches in the ED. This prospective, randomized, double-blind study was conducted in an ED of a tertiary care hospital using allocation concealment. Patients were allocated into two arms to receive the study drug; 50 mg dexketoprofen in 50 ml saline and 50 ml saline as placebo. Change in pain intensity was measured by the visual analog scale at baseline, both at 30 and 45 minutes after the study medication was administered. Rescue medication requirement and pain relapse were also recorded by a telephone follow-up at 48 hours. A total of 224 patients (112 in each group) were included into the final analysis. Mean age of the study participants was 37 ± 11 (SD) and 25% (n = 56) of them were male. The median pain improvement at 45 minutes for patients receiving dexketoprofen was 55 (IQR: 49 to 60) and 30 (IQR: 25 to 35) for those receiving placebo. The mean difference between the two groups at 45 minutes was 21.4 (95% CI: 14.4. to 28.5). Rescue drugs were needed in 22.3% of patients who received dexketoprofen compared to 55.4% in patients who received placebo (dif: 33.1%; 95% CI: 20% to 45%). There were no adverse events reported in either group during the study period. Intravenous dexketoprofen is superior to placebo in relieving migraine headaches in the ED. It may be a suitable therapy with minimum side effects in patients presenting with a migraine headache to the ED. © International Headache Society 2015.

Tecnologia assistiva em saúde para cegos: enfoque na prevenção de drogas Tecnología asistiva en salud para ciegos: enfoque en la prevención de drogas Assistive health technology for the blind people: a focus on drugs prevention

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Kariane Gomes Cezario

2007-12-01

Full Text Available Diante da nocividade das drogas aos indivíduos e da vulnerabilidade dos cegos a elas, em virtude de condições favoráveis, objetivou-se desenvolver e avaliar Tecnologia Assistiva em Saúde, acessível a esta clientela. Estudo de desenvolvimento e avaliação de Tecnologia Assistiva em Saúde, sobre a prevenção ao uso de drogas entre cegos, realizado em uma associação de cegos, em Fortaleza, em abril de 2007. Participaram cinco homens, que apreciaram o recurso tecnológico constituído do texto educativo Drogas: Reflexão para prevenção, utilizado em programa de computador de síntese de voz (Dosvox. Seu conteúdo abordou os principais tipos de drogas, efeitos físicos, psicológicos e sociais, além de meios de prevenção. Fez-se avaliação por meio de depoimentos. A Tecnologia Assistiva foi considerada informativa, satisfatória e alcançou o objetivo proposto. Neste tipo de recurso, a educação em saúde foi vista como válida.Ante la nocividad de las drogas a los individuos y la vulnerabilidad de los ciegos a ellas, en virtud de condiciones favorables, la finalidad fue desarrollar y evaluar tecnología asistiva en salud, accesible a esta clientela. Estudio de desarrollo y evaluación de Tecnología Asistiva en Salud, sobre la prevención del uso de drogas entre ciegos, realizado en una asociación de ciegos, en Fortaleza, Brasil, en abril de 2007. Participaron cinco hombres, que apreciaron el recurso tecnológico, que constituyó del texto educativo Drogas: Reflexión para prevención, utilizado en programa de computadora, de síntesis de voz (Dosvox. Su contenido aborda los principales tipos de drogas; sus efectos físicos, psicológicos, e sociales; además de medios de prevención. La evaluación se efectuó mediante testimonios. La Tecnología Asistiva fue considerada informativa, satisfactoria y alcanzó el objetivo a que se propone. En este tipo de recurso, la educación en salud se consideró como válida.In view of the

Desempenho e qualidade de ovos de galinhas poedeiras criadas em gaiolas enriquecidas e ambiente controlado

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Daniele L. de Oliveira

2014-11-01

Full Text Available Objetivou-se, neste trabalho, avaliar o desempenho e a qualidade dos ovos de poedeiras criadas em gaiolas enriquecidas e ambiente controlado, alojadas em câmara climática sob três temperaturas: 20, 26 e 32 ºC e U.R, 60%. As gaiolas apresentavam bebedouros, comedouros, ninhos e uma área com areia e lixa. Foram utilizadas 36 poedeiras da linhagem Dekalb White, com 27 semanas de idade, com seis aves/gaiolas. Foram analisados o consumo de ração e água, a produção e a qualidade dos ovos. O delineamento experimental foi inteiramente casualizado, com três tratamentos e seis repetições. Nas condições ambiente de 20 e 26 ºC as aves se mostraram dentro da zona de conforto térmico sem diferença significativa e apresentando efeito positivo na qualidade dos ovos com melhores valores das médias nos parâmetros de qualidade. Na temperatura ambiente de 32 ºC, considerada fora da zona de conforto térmico, as aves apresentaram evidências de estresse térmico, propiciando aumento da ingestão de água, redução no consumo de ração, redução nos valores de percentual de produção e nos parâmetros de qualidade dos ovos. As gaiolas enriquecidas foram adequadas às galinhas apresentando produção de ovos com boa resistência da casca.

An algorithm for evaluating the ethics of a placebo-controlled trial.

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Amdur, R J; Biddle, C J

2001-10-20

The purpose of this article is to clarify the decision points that are important to consider when evaluating the ethics of a placebo-controlled trial. The ethical requirements for research involving human subjects are reviewed, and the rationale for and potential problems with concomitant placebo control are explained. A series of case discussions are used to illustrate each decision point. The critical decision points in the evaluation of the ethics of a placebo-controlled trial are as follows: (i) Is placebo being used in place of standard therapy? (ii) Is standard therapy likely to be effective? (iii) Is the toxicity of standard therapy such that patients routinely refuse this treatment? (iv) Could the use of placebo result in severe suffering or irreversible harm? (v) Is the variability in the placebo response such that it is reasonable to consider other options for the control group? (vi) Would a reasonable person with an average degree of altruism and risk aversiveness agree to participate in this study? The algorithm presented in this article gives researchers and research monitors (such as Institutional Review Board members) the tools they need to evaluate the ethics of a study that uses concomitant placebo control. Copyright 2001 Wiley-Liss, Inc.

Placebo and Nocebo Effects in Sexual Medicine: An Experimental Approach.

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Kruger, Tillmann H C; Grob, Carolin; de Boer, Claas; Peschel, Thomas; Hartmann, Uwe; Tenbergen, Gilian; Schedlowski, Manfred

2016-11-16

Few studies have investigated placebo and nocebo effects in a human sexuality context. Studying placebo and nocebo responses in this context may provide insight into their potential to modulate sexual drive and function. To examine such effects in sexual medicine, 48 healthy, male heterosexual participants were divided into four groups. Each group received instruction to expect stimulating effects, no effect, or an inhibitory effect on sexual functions. Only one group received the dopamine agonist cabergoline; all other groups received placebo or nocebo. Modulations in sexual experience were examined through an established experimental paradigm of sexual arousal and masturbation-induced orgasm during erotic film sequences with instruction to induce placebo or nocebo effects. Endocrine data, appetitive, consummatory, and refractory sexual behavior parameters were assessed using the Arizona Sexual Experience Scale (ASEX) and the Acute Sexual Experience Scale (ASES). Results showed increased levels of sexual function after administration of cabergoline with significant effects for several parameters. Placebo effects were induced only to a small degree. No negative effects on sexual parameters in the nocebo condition were noted. This paradigm could induce only small placebo and nocebo effects. This supports the view that healthy male sexual function seems relatively resistant to negative external influences.

How can placebo effects best be applied in clinical practice? A narrative review

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Bystad M

2015-01-01

Full Text Available Martin Bystad,1,2 Camilla Bystad,3 Rolf Wynn1,3 1Division of Addictions and Specialized Psychiatric Services, University Hospital of North Norway, 2Institute of Psychology, 3Institute of Clinical Medicine, Faculty of Health Sciences, Arctic University of Norway, Tromsø, Norway Abstract: Placebo effects are documented in a number of clinical and experimental studies. It is possible to benefit from placebo effects in clinical practice by using them as effects additive to those of documented and effective treatments. The purpose of this paper is to discuss how doctors and other health workers may benefit from placebo effects within an ethical framework. A narrative review of the literature relating to placebo effects in clinical practice was performed. We searched PubMed and selected textbooks on placebo effects for articles and book chapters relating to placebo effects in clinical practice. By drawing on placebo effects, doctors may access patients’ self-healing potentials. In practice, doctors may best benefit from placebo effects by influencing the patient’s expectations through communication. An important principle is to give the patient information stating that a particular treatment is effective, as long as this is based on realistic optimism. A patient-centered style involving elements such as developing trust and respect, exploring the patient’s values, speaking positively about treatments, and providing reassurance and encouragement might aid in activating placebo effects. The total effect of a documented treatment will partly depend on how well the placebo effects have been activated. Thus, placebo effects can be understood as a form of supplemental treatment. Keywords: placebo effects, doctor-patient communication, expectations, biopsychosocial model

Un análisis del escenario económico del Perú y Chile, desde la perspectiva del doble diamante de la competitividad global

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Jesús C. Peña-Vinces

2009-11-01

Full Text Available Las pequeñas economías, como la peruana y chilena, se encuentran inmersas en la arena global de las economías emergentes, por lo que evaluarlas desde un punto de vista puramente local (Porter1990 sería un enfoque bastante limitado y poco útil. Este hecho hace que el diamante nacional de Porter (1990 resulte, a todas luces, insuficiente para dicho propósito (Moon et al. 1998: 135. Este artículo analiza las economías mencionadas desde un enfoque más global, que incluye tanto el mercado local como el extranjero; es decir, evaluarlo desde la perspectiva del doble diamante de la competitividad internacional propuesta por Moon et al. (1998, y Moon y Lee (2004: 138.

Experimental cardiac arrest treatment with adrenaline, vasopressin, or placebo.

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Palácio, Manoel Ângelo Gomes; Paiva, Edison Ferreira de; Azevedo, Luciano Cesar Pontes de; Timerman, Ari

2013-12-01

The effect of vasoconstrictors in prolonged cardiopulmonary resuscitation (CPR) has not been fully clarified. To evaluate adrenaline and vasopressin pressure effect, and observe the return of spontaneous circulation (ROSC). A prospective, randomized, blinded, and placebo-controlled study. After seven minutes of untreated ventricular fibrillation, pigs received two minutes cycles of CPR. Defibrillation was attempted (4 J/kg) once at 9 minutes, and after every cycle if a shockable rhythm was present, after what CPR was immediately resumed. At 9 minutes and every five minutes intervals, 0.02 mg/kg (n = 12 pigs) adrenaline, or 0.4 U/kg (n = 12) vasopressin, or 0.2 mL/kg (n = 8) 0.9% saline solution was administered. CPR continued for 30 minutes or until the ROSC. Coronary perfusion pressure increased to about 20 mmHg in the three groups. Following vasoconstrictors doses, pressure level reached 35 mmHg versus 15 mmHg with placebo (p < 0.001). Vasopressin effect remained at 15-20 mmHg after three doses versus zero with adrenaline or placebo. ROSC rate differed (p = 0.031) among adrenaline (10/12), vasopressin (6/12), and placebo (2/8). Time-to-ROSC did not differ (16 minutes), nor the number of doses previously received (one or two). There was no difference between vasoconstrictors, but against placebo, only adrenaline significantly increased the ROSC rate (p = 0.019). The vasoconstrictors initial pressure effect was equivalent and vasopressin maintained a late effect at prolonged resuscitation. Nevertheless, when compared with placebo, only adrenaline significantly increased the ROSC rate.

Astronomía para ciegos y amblíopes. Proyecto de construcción de un planetario especial en la ciudad de Mar del Plata

Science.gov (United States)

Musso, S.

?`Qué es la Astronomía para Ciegos?. El trabajo es una adaptación en base a la escala de magnitudes de Hipparco que cambia el concepto de luz por una adaptación sonora, donde las estrellas de magnitud 6 se escuchan en 10 dB, más o menos lo que consideramos el umbral de la audición humana. Quienes no escuchan muy bien no pueden escuchar las magnitudes 6, de la misma manera que muchos de nosotros, que no poseemos una visión perfecta, no podemos observar esas mismas estrellas en el cielo (más allá de la polución). A los astros de magnitud 5 vamos a relacionarlos a un sonido en 20 dB. Y así sucesivamente. También los colores estarán representados en una convención de graves a agudos y lo mismo algunas características del cielo. Por ejemplo, la Vía Láctea se mostrará como un ``ruido", como bien nos lo hicieron ver nuestros futuros destinatarios. En Mar del Plata nos encontramos ya trabajando en un proyecto que tiene como objetivo final la construcción del Primer Planetario Acústico del Mundo, una herramienta para la enseñanza de la astronomía, un espacio para la lucha contra la discriminación del discapacitado y una posibilidad de ``ver el cielo de un modo diferente".

Controlled environment laboratory for the energy certification of refrigeration and air conditioning systems; Laboratorio de ambiente controlado para la certificacion energetica de sistemas de refrigeracion y aire acondicionado

Energy Technology Data Exchange (ETDEWEB)

Ambriz, Juan Jose; Romero Paredes, Hernando; Dorantes, Ruben [Universidad Autonoma Metropolitana, Mexico, D.F. (Mexico)

1999-07-01

In this paper the general characteristics of the Controlled Environment Laboratory (CELAB) are described and some of the possible tests that could be performed in this device to evaluate the energy efficiency in air conditioning systems, domestic refrigeration and industrial refrigeration, as well as tests to evaluate the hydrothermal comfort in national populations, are presented. [Spanish] En este trabajo se describen las caracteristicas generales del Laboratorio de Ambiente Controlado (LAB), y se presentan algunas de las posibles pruebas que podran ser desarrolladas en este dispositivo para evaluar la eficiencia energetica en sistemas de aire acondicionado, refrigeracion domestica y refrigeracion industrial, asi como para pruebas para evaluar el confort hidrotermico en poblaciones nacionales.

Placebos and painkillers: is mind as real as matter?

Science.gov (United States)

Colloca, Luana; Benedetti, Fabrizio

2005-07-01

Considerable progress has been made in our understanding of the neurobiological mechanisms of the placebo effect, and most of our knowledge originates from the field of pain and analgesia. Today, the placebo effect represents a promising model that could allow us to shed new light on mind-body interactions. The mental events induced by placebo administration can activate mechanisms that are similar to those activated by drugs, which indicates a similarity between psychosocial and pharmacodynamic effects. These new neurobiological advances are already changing our conception of how clinical trials and medical practice must be viewed and conducted.

Seguridad del paciente en Radioterapia Intraoperatoria: Impacto de los elementos controlados por el Radiofisico

Science.gov (United States)

Tarjuelo, Juan Lopez

Introduccion: En la administracion de la radioterapia intervienen profesionales y equipos de tratamiento, por lo que existe el riesgo de error y se precisa que dicho equipamiento funcione conforme a lo esperado. A los radiofisicos les corresponde participar en las actividades de garantia o aseguramiento de la calidad, incluyendo el control de calidad de los equipos, y en la evaluacion de los riesgos asociados. La radioterapia intraoperatoria (RIO) es una tecnica radioterapica de intensificacion de dosis, altamente selectiva, dirigida a volumenes anatomicos restringidos durante el tratamiento quirurgico oncologico, basada en la administracion de una dosis absorbida alta por medio de un haz de electrones tras el examen visual directo del lecho tumoral. Como incorporar los ultimos avances en el refuerzo de la seguridad en radioterapia es una tarea ambiciosa y compleja, resulta mas concreta y de inmediata aplicacion su introduccion en la RIO. El objetivo es analizar los elementos que reducen los riesgos y aumentan la seguridad en la RIO y su dosimetria, y valorar la funcion del radiofisico en esta labor. Material y metodos: Se emplearon el planificador Radiance de GMV y el acelerador lineal de los tratamientos de RIO Elekta Precise, controlado con el verificador diario de haces Daily QA Check 1090 y medido con las camaras de ionizacion PPC 40, FC65-G y FC65-P de PTW-Freiburg, a su vez verificadas con fuentes radiactivas adecuadas de estroncio-90 modelos CDP y CDC de IBA Dosimetry. Se realizo un analisis de modos de fallo y efectos (failure mode and effect analysis, FMEA) con el fin de identificar los elementos que forman la RIO y aplicar las herramientas necesarias para la minimizacion de los riesgos y la mejora de la seguridad en la tecnica. Se estudiaron las verificaciones diarias de dicho acelerador Precise con el control estadistico de procesos (statistical process control, SPC) y se simularon intervenciones para devolverlo al estado llamado en control. El SPC

A percepção de cegos e cegas diante das drogas La percepción de ciegos y ciegas frente a las drogas Blind men and women' perceptions of the use of illegal drugs

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Lorita Marlena Freitag Pagliuca

2009-01-01

Full Text Available OBJETIVO: Compreender a percepção de mulheres e homens cegos sobre as drogas, comparando semelhanças e diferenças. MÉTODOS: Estudo descritivo, qualitativo, realizado em uma associação de cegos, em Fortaleza-CE, entre outubro de 2006 e março de 2007. A coleta de dados utilizou a entrevista com questão norteadora. A amostra foi limitada por saturação com cinco mulheres e sete homens. Adotou-se o método de Análise de Conteúdo, obtendo-se três temas. RESULTADOS: Os temas - O que sei - definem o que é droga e abrangência desta problemática; O que vivi - relatam repercussão das experiências pessoais e familiares com o uso das drogas; e O que penso sobre a prevenção - opinam sobre estratégias de prevenção. CONCLUSÕES: A problemática é entendida como agravante à saúde pública, afetando a sociedade e a vida do usuário. As influências de familiares, amigos e mídia aproximam às drogas ou não, reforçando a pertinência da promoção da saúde e prevenção entre os cegos.OBJETIVO: Comprender la percepción de mujeres y hombres ciegos sobre las drogas, comparando semejanzas y diferencias. MÉTODOS: Se trata de un estudio descriptivo, cualitativo, realizado en una asociación de ciegos, en Fortaleza-CE, entre octubre del 2006 y marzo del 2007. Para la recolección de datos se utilizó la entrevista con pregunta norteadora. La muestra conformada por cinco mujeres y siete hombres fue determinada por saturación. Se adoptó el método de Análisis de Contenido, obteniéndose tres temas. RESULTADOS: Los temas - ¿qué sé? - definen lo que es la droga y la magnitud de esta problemática; ¿qué viví? - relatan la repercusión de las experiencias personales y familiares con el uso de las drogas; y ¿qué pienso sobre la prevención? - reflejan las estrategias de prevención. CONCLUSIONES: La problemática es entendida como un agravante a la salud pública, afectando a la sociedad y la vida del usuario. Las influencias de

The use of pure and impure placebo interventions in primary care - a qualitative approach

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Senn Oliver

2011-03-01

Full Text Available Abstract Background Placebos play an important role in clinical trials and several surveys have shown that they are also common in daily practice. Previous research focused primarily on the frequency of placebo use in outpatient care. Our aim was to explore physicians' views on the use of placebos in daily practice, whereby distinction was made between pure placebos (substances with no pharmacological effect, e.g. sugar pills and impure placebos (substances with pharmacological effect but not on the condition being treated, e.g. antibiotics in viral infections or vitamins. Methods We performed semi-structured interviews with a sample of twelve primary care physicians (PCPs. The interview addressed individual definitions of a placebo, attitudes towards placebos and the participants' reasons for prescribing them. The interviews were transcribed and analysed using qualitative content analysis. Results The definition of a placebo given by the majority of the PCPs in our study was one which actually only describes pure placebos. This definition, combined with the fact that most impure placebos were not regarded as placebos at all, means that most of the participating PCPs were not aware of the extent to which placebos are used in daily practice. The PCPs stated that they use placebos (both pure and impure mainly in the case of non-severe diseases for which there was often no satisfactory somatic explanation. According to the PCPs, cases like this are often treated by complementary and alternative therapies and these, too, are associated with placebo effects. However, all PCPs felt that the ethical aspects of such treatment were unclear and they were unsure as to how to communicate the use of placebos to their patients. Most of them would appreciate ethical guidelines on how to deal with this issue. Conclusions Many PCPs seem to be unaware that some of the drugs they prescribe are classified as impure placebos. Perceptions of effectiveness and doubts

A polysomnographic placebo-controlled evaluation of the efficacy and safety of eszopiclone relative to placebo and zolpidem in the treatment of primary insomnia.

Science.gov (United States)

Erman, Milton K; Zammit, Gary; Rubens, Robert; Schaefer, Kendyl; Wessel, Thomas; Amato, David; Caron, Judy; Walsh, James K

2008-06-15

To evaluate the polysomnographic efficacy and the safety of a range of doses of eszopiclone relative to placebo in patients with primary insomnia. Zolpidem 10 mg was included as an active control. This multicenter, randomized, crossover study enrolled patients aged 21-64 years meeting the DSM-IV criteria for primary insomnia (n = 65). Patients received 2 nights treatment each with placebo, eszopiclone 1 mg, 2 mg, 2.5 mg, or 3 mg, and zolpidem 10 mg after randomization to one of 6 treatment sequences. Visits were separated by a 3-7 day washout. Objective efficacy was assessed by polysomnography (PSG). The primary endpoint was latency to persistent sleep (LPS); key secondary endpoints were sleep efficiency (SE) and wake time after sleep onset (WASO); other endpoints included wake time during sleep (WTDS) and number of awakenings (NAW), as well as patient-reported variables. LPS and SE were significantly different than placebo for all active treatments (p zolpidem 10 mg or the other eszopiclone doses. The incidence of central nervous system adverse events was 23.4% for zolpidem 10 mg, 6.2% to 12.5% for the eszopiclone doses, and 7.9% for placebo. Relative to placebo, all active treatments were effective in reducing LPS and increasing SE. Eszopiclone 3 mg was significantly different from placebo on the 3 PSG measures of sleep maintenance (WASO, WTDS, and NAW). Significant differences between zolpidem 10 mg and eszopiclone (2 mg or 3 mg) were not observed for PSG-measured outcomes, although the study was not powered to detect differences between the active drug conditions.

Intervenciones Placebo Para Incrementar el Rendimiento Deportivo: un Tema Revisitado/ Placebo Interventions to Enhance Sports Performance: Revisiting an Issue/ Intervenções Placebo para Aumentar o Rendimento Esportivo: um Tema Revisitado

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Mildreth Larquin-Castillo

2015-05-01

Full Text Available Las intervenciones psicológicas para incrementar el rendimiento de los deportistas han ganado gran popularidad. En este artículo se realizó una revisión de la utilización de intervenciones placebo para potenciar el rendimiento deportivo, a partir de la cual se concluyó que el contexto de aplicación, los rasgos de personalidad del deportista y el ritual de intervención han sido propuestos como los factores más relevantes a tomar en consideración. Se estima que, a pesar de las limitaciones, las intervenciones placebo constituyen alternativas eficaces que tienen distintos modos de aplicación. La utilización de vías conscientes y no-conscientes para activar el efecto placebo se materializa en el empleo de las potencialidades que brindan tanto la sugestión verbal como el priming.

Structural Models Describing Placebo Treatment Effects in Schizophrenia and Other Neuropsychiatric Disorders

NARCIS (Netherlands)

Reddy, Venkatesh Pilla; Kozielska, Magdalena; Johnson, Martin; Vermeulen, An; de Greef, Rik; Liu, Jing; Groothuis, Geny M. M.; Danhof, Meindert; Proost, Johannes H.

2011-01-01

Large variation in placebo response within and among clinical trials can substantially affect conclusions about the efficacy of new medications in psychiatry. Developing a robust placebo model to describe the placebo response is important to facilitate quantification of drug effects, and eventually

The placebo effect in sports performance: a brief review.

Science.gov (United States)

Beedie, Christopher J; Foad, Abigail J

2009-01-01

The placebo effect, with its central role in clinical trials, is acknowledged as a factor in sports medicine, although until recently little has been known about the likely magnitude and extent of the effect in any specific research setting. Even less is known about the prevalence of the effect in competitive sport. The present paper reviews 12 intervention studies in sports performance. All examine placebo effects associated with the administration of an inert substance believed by subjects to be an ergogenic aid. Placebo effects of varying magnitudes are reported in studies addressing sports from weightlifting to endurance cycling. Findings suggest that psychological variables such as motivation, expectancy and conditioning, and the interaction of these variables with physiological variables, might be significant factors in driving both positive and negative outcomes. Programmatic research involving the triangulation of data, and investigation of contextual and personality factors in the mediation of placebo responses may help to advance knowledge in this area.

Understanding placebo, nocebo, and iatrogenic treatment effects.

Science.gov (United States)

Bootzin, Richard R; Bailey, Elaine T

2005-07-01

Placebo and nonplacebo treatments have both positive and negative effects on patient outcomes. To better understand the patterning of treatment effects, three specific interventions will be discussed that are reported to produce more harm than benefit: critical incident stress debriefing, group therapy for adolescents with conduct disorders, and psychotherapy for dissociative identity disorder. In each case, there is an interaction between mechanisms thought to underlie both placebo and specific treatment effects. Mechanisms hypothesized to underlie placebo and nocebo effects include patient expectancy, self-focused attention to symptoms, motivation to change, and sociocultural role-enactment cues. In the three treatments discussed, specific mechanisms interact with nonspecific mechanisms to produce iatrogenic effects. To advance knowledge, it is important both to specify the theory of treatment and its expected outcomes and to put the theory to test. Only with attention to the empirical findings from programmatic research of specific and nonspecific effects and their interaction is it possible to improve the outcomes of treatment beyond the status quo.

Identificación e implementación de paquetes tecnológicos en ganadería vacuna de doble propósito. Caso Manabí-Ecuador

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Yenny Torres

2014-01-01

Full Text Available El avance en los sistemas ganaderos se asocia a la implementación de tecnologías en la producción y a la mejora de sus ingresos. El objetivo del presente estudio fue la identificación e implementación de paquetes te cnológicos y su relación con los resultados productivos en vacuno de doble propósito de la provincia de Manabí, Ecua dor en dos zonas climáticas: el Bosque seco tropical y el húmedo tropical. Se agrupan 25 tecnologías en seis paquetes tecnológicos (PT seleccionadas mediante una metodología cualitativa y participativa. Se realizaron entrevistas en una muestra de 41 explotaciones para evaluar la implementación de los paquetes tecnológicos, mediante estadística desc riptiva, correlaciones de Sperman y regresiones múltiples. Se obtienen los mayores niveles de implementación en los paquetes de salud animal (76 %, uso de la tierra y alimentación (55 %. El PT de alimentación se correlacion a ( P <0.01 con el PT de instalaciones (0.711 y de reproducción (0.774. Los PT explican 30 % de la variabilidad de la producción de leche, que es debida al uso de la tierra en el Bosque seco y a la salud animal en el Bosque húmed o. Esta investigación genera resultados preliminares respecto a la idententificación e implementación de los principales paquetes tecnológicos en la ganadería vacuna de doble propósito de Manabí – Ecuador, que están en pr oceso de mejora aunque sin perder los atri butos que lo caracterizan.

Attitudes and beliefs about placebo surgery among orthopedic shoulder surgeons in the United Kingdom.

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Karolina Wartolowska

Full Text Available To survey surgeons on their beliefs and attitudes towards the use of placebo in surgery.British orthopedic shoulder surgeons, attending a national conference in the United Kingdom, were asked to complete a self-report online questionnaire about their beliefs and attitudes towards the use of placebo related to surgical intervention. The survey included questions about ethical issues, the mechanism of placebo effects, and any concerns regarding its use.100 surgeons who participated in the survey believed that placebo surgery is ethically acceptable (96%, especially as a part of a clinical trial (46%. Respondents thought that a placebo effect in surgery is real i.e. has a scientific basis (92%, that placebo can be therapeutically beneficial (77%, and that it involves psychological mechanisms (96%. Over half of the respondents (58% have used a surgical procedure with a significant placebo component at least once in their professional career. Their main concern about placebo use in surgery was that it might involve an element of deception.Surgeons generally agreed that a placebo component to surgical intervention might exist. They also supported placebo use in clinical trials and considered it ethical, providing it does not involve deception of patients. More studies are needed, particularly among other surgical specialties and with larger numbers of participants, to better understand the use of placebo in surgery.

Placebo-Controlled Study of Pimozide Augmentation of Fluoxetine in Body Dysmorphic Disorder

Science.gov (United States)

Phillips, Katharine A.

2006-01-01

Objective Although body dysmorphic disorder often responds to serotonin reuptake inhibitors (SRIs), most patients do not respond or respond only partially. However, placebo-controlled studies of augmentation of SRIs have not been done. Furthermore, although 40%–50% of patients are delusional, studies of antipsychotic medications have not been done. Method Twenty-eight patients with body dysmorphic disorder or its delusional variant participated in an 8-week, placebo-controlled, double-blind, parallel-group study of pimozide augmentation of fluoxetine. Results Pimozide was not more effective than placebo: two (18.2%) of 11 subjects responded to pimozide and three (17.6%) of 17 subjects responded to placebo. There was no significant effect of baseline delusionality on endpoint severity of body dysmorphic disorder. Delusionality did not decrease significantly more with pimozide than placebo. Conclusions Pimozide augmentation of fluoxetine treatment for body dysmorphic disorder was not more effective than placebo, even in more delusional patients. Further studies of augmentation for SRIs are needed. PMID:15677604

Efecto de colutorio-gel de clorhexidina sobre el crecimiento de placa en 24 horas = Effect of chlorhexidine mouthrinses-gel on de novo plaque formation in 24 hours

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Rivera, Tânia

2006-01-01

Full Text Available En un estudio cruzado, doble ciego y randomizado, 25 alumnos de Odontologia de buena salud oral, participaron de cuatro estudios donde ellos se abtuvieron de toda limpieza mecanica oral por 24 horas, los estudios estuvieron separados entre si por 4 semanas. Durante los estudios los alumnos en un randomizado orden, se enjuagaron por una vez con uno de los siguientes colutorios: CHX 0.12% + alcohol (Oralgene®, CHX 0.12% + alcohol (Perio.Aid®, CHX 0.1% + alcohol (Dentilim® y CHX 0.1% + HMC 2.5% (Colutoriogel®, nueva formula. Despues de un dia se midio formación de placa, se completo y registro el cuestionario de parametros clinicos. Las formulaciones de CHX 0.12% + alcohol y CHX 0.1% + HMC 2.5% se mostraron eficientes en retardar el crecimiento de placa dental de novo, esto obtenido de las observaciones clinicas, y siempre superior (p < 0.05 a la formulación del colutorio de CHX 0.1%+ alcohol (Dentilim®. Los resultados de este estudio demuestran el potencial clinico de este nuevo colutorio-gel sin alcohol de CHX 0.1% + HMC 2.5% (Colutoriogel® como un efectivo agente antiplaca y con reducidas efectos secundarios registrados

A systematic review of sex differences in the placebo and the nocebo effect

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Vambheim SM

2017-07-01

Full Text Available Sara M Vambheim,1 Magne Arve Flaten2 1Department of Psychology, UiT, The Arctic University of Norway, Tromsø, 2Department of Psychology, Norwegian University of Science and Technology (NTNU, Trondheim, Norway Objectives: The present review investigated whether there are systematic sex differences in the placebo and the nocebo effect. Methods: A literature search was conducted in multiple electronic databases. Studies were included if the study compared a group or condition where a placebo was administered to a natural history group or similar cohort. Results: Eighteen studies were identified – 12 on placebo effects and 6 on nocebo effects. Chi-square tests revealed that 1 males responded more strongly to placebo treatment, and females responded more strongly to nocebo treatment, and 2 males responded with larger placebo effects induced by verbal information, and females responded with larger nocebo effects induced by conditioning procedures. Conclusion: This review indicates that there are sex differences in the placebo and nocebo effects, probably caused by sex differences in stress, anxiety, and the endogenous opioid system. Keywords: placebo response, nocebo response, placebo analgesia, nocebo hyperalgesia, sex differences

Efectos de cruzamiento para producción de leche y características de crecimiento en bovinos de doble propósito en el trópico húmedo

OpenAIRE

Sergio Iván Román-Ponce; Felipe de Jesús Ruiz-López; Hugo H. Montaldo; Rita Rizzi; Heriberto Román-Ponce

2013-01-01

Con el objetivo de evaluar los efectos de cruzamiento en tres subpoblaciones de ganado bovino cruzados de doble propósito en el trópico húmedo se utilizaron 5,040 lactancias y pesajes corporales al nacimiento [4,429] y pesos ajustados a 205 [3.878], 365 [3,017] y 540 [2,276] días (PN, P205, P365 y P540, respectivamente) de Cebú (CE) y sus cruzas con Holstein (HS), Suizo Pardo (SP) y Simmental (SM). Los efectos aditivos directos de raza (PG), heterocigocidad (HT) y pérdidas por recombinación (...

Le cerveau sous effet placebo

OpenAIRE

Touzet , Claude

2017-01-01

International audience; Comment le fait de croire qu’on nous injecte de la morphine (alors qu’il s’agit de sérum physiologique) peut-il faire disparaître la douleur ? Investigation sur le cerveau sous placebo.

[Placebo effect: a contribution of social psychology].

Science.gov (United States)

Balez, R; Leroyer, C; Couturaud, F

2014-10-01

This article reviews the psychosocial variables, which are of interest in the relationship between the patient and the physician. According to a classical model of social psychology, such a relationship might contribute to the placebo/nocebo effects. We develop herein various relational and contextual variables, taking into account four dimensions (intra-individual, interpersonal, positional and ideological) and their potential effects on therapeutic responses. This applies both in the setting of daily clinical practice and of clinical trials. The placebo effect offers an opportunity for collaboration and dialogue between social scientists and physicians.

EEES, COMPETENCIAS Y APRENDIZAJE DEL DERECHO ROMANO MEDIANTE EL MÉTODO DEL CASO (I: EL DOBLE MATRIMONIO

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Elisa Muñoz Catalan

2013-01-01

Full Text Available Con la realización del presente trabajo pretendemos investigar sobre la importancia actual de aplicar el método del caso en la enseñanza del Derecho Romano, frente a las tradicionales clases teóricas y magistrales. Reparando, muy especialmente, en el alcance de las exigencias metodológicas surgidas con los nuevos planes del estudio Grado en Derecho en el marco del EEES; así como en el desarrollo de una serie de competencias generales y específicas en los estudiantes, que les van a ser muy útiles una vez que finalicen el Grado y se enfrenten a las dificultades del mercado actual, ya que se consideran como los verdaderos protagonistas del proceso de enseñanza-aprendizaje. Por tanto, con la puesta en práctica de este primer caso sobre doble matrimonio romano, ausencia de testamento y herederos legítimos, intentamos acercar al alumnado al casuismo jurisprudencial romano; de este modo, comprenderán que lo importante no es dar la solución al supuesto planteado, sino razonar jurídicamente consiguiendo, a través de debates en grupos, un conocimiento más profundo de las reglas e instituciones aplicables.

Projeto e desenvolvimento de um carro robô controlado por smartphone, utilizando a plataforma Amarino

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Otávio Souza Martins Gomes

2015-01-01

Full Text Available Este artigo mostra a construção de um carro robô controlado por dispositivos móveis utilizando o sistema operacional Android e uma placa de prototipagem open source (Arduino. Utilizou-se de motores para sua movimentação e sensores para interação com o ambiente. O envio de comandos foi realizado utilizando a tecnologia Bluetooth e é capaz de movimentar o carro robô em todas as direções de acordo com os comandos do usuário. Sensores instalados no carro coletam informações do ambiente que são enviadas ao dispositivo Android. A construção bem sucedida deste carro robô mostra que é possível implementar novas funcionalidades para esse produto, bem como apoiar outros projetos relacionados a esse tema.Palavras-chave: Arduino. Android. Bluetooth. Carro robô. Robótica. Project and development of a robot car controlled by smartphone, using the platform amarinoABSTRACTThis work shows the build of a robot car controlled by mobile devices employing Android operating system and an open source prototyping board (Arduino. Motors for its movements and sensors for its environment interaction were employed. The commands are transmitted using Bluetooth technology which can move the robot car in all directions according to the user commands. Sensors installed in the car collect the environment information which is sent to the Android device. The success build of this robot car shows that new features can be possible implemented as well as to support other projects related to this research area.Keywords: Arduino. Android. Bluetooth. Robot car. Robotic.

The placebo effect and homeopathy.

Science.gov (United States)

Teixeira, Marcus Z; Guedes, Cristina H F F; Barreto, Patrícia V; Martins, Mílton A

2010-04-01

Like other forms of medicine, including Complementary and Alternative Medicine (CAM), homeopathy elicits expectations in patients. The physician-patient relationship, personal and comprehensive treatment and lack of adverse effects are elements in creating positive expectations. Other elements may be associated with negative expectations. We conducted a systematic literature review on placebo and nocebo effects in acupuncture and homeopathy using Medline. Findings on the psychophysiological and neuromediating mechanisms of the placebo-nocebo phenomenon are reviewed. Studies of these effects reveal how expectations and unconscious conditioning can be measured by imaging and EEG methods. They result in significant, non-specific therapeutic effects, which may confuse the evaluation of the specific therapeutic effects treatment, hampering selection of the simillimum. Directions for future research on non-specific therapeutic effects of homeopathy to improve clinical practice and clinical research are discussed.

Ketamine for Social Anxiety Disorder: A Randomized, Placebo-Controlled Crossover Trial.

Science.gov (United States)

Taylor, Jerome H; Landeros-Weisenberger, Angeli; Coughlin, Catherine; Mulqueen, Jilian; Johnson, Jessica A; Gabriel, Daniel; Reed, Margot O; Jakubovski, Ewgeni; Bloch, Michael H

2018-01-01

Many patients with social anxiety disorder (SAD) experience inadequate symptom relief from available treatments. Ketamine is a potent N-methyl-D-aspartate receptor antagonist with a potentially novel mechanism of action for the treatment of anxiety disorders. Therefore, we conducted a double-blind, randomized, placebo-controlled crossover trial in 18 adults with DSM-5 SAD and compared the effects between intravenous ketamine (0.5 mg/kg over 40 min) and placebo (normal saline) on social phobia symptoms. Ketamine and placebo infusions were administered in a random order with a 28-day washout period between infusions. Ratings of anxiety were assessed 3-h post-infusion and followed for 14 days. We used linear mixed models to assess the impact of ketamine and placebo on anxiety symptoms. Outcomes were blinded ratings on the Liebowitz Social Anxiety Scale (LSAS) and self-reported anxiety on a visual analog scale (VAS-Anxiety). We also used the Wilcoxon signed-rank test to compare the proportion of treatment responders. Based on prior studies, we defined response as a greater than 35% LSAS reduction and 50% VAS-Anxiety reduction. We found ketamine resulted in a significantly greater reduction in anxiety relative to placebo on the LSAS (Time × Treatment: F 9,115 =2.6, p=0.01) but not the VAS-Anxiety (Time × Treatment: F 10,141 =0.4, p=0.95). Participants were significantly more likely to exhibit a treatment response after ketamine infusion relative to placebo in the first 2 weeks following infusion measured on the LSAS (33.33% response ketamine vs 0% response placebo, Wilcoxon signed-rank test z=2.24, p=0.025) and VAS (88.89% response ketamine vs 52.94% response placebo, Wilcoxon signed-rank test z=2.12, p=0.034). In conclusion, this proof-of-concept trial provides initial evidence that ketamine may be effective in reducing anxiety.

Attitudes toward Placebo-Controlled Clinical Trials of Patients with Schizophrenia in Japan.

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Norio Sugawara

Full Text Available Although the use of placebo in clinical trials of schizophrenia patients is controversial because of medical and ethical concerns, placebo-controlled clinical trials are commonly used in the licensing of new drugs.The objective of this study was to assess the attitudes toward placebo-controlled clinical trials among patients with schizophrenia in Japan.Using a cross-sectional design, we recruited patients (n = 251 aged 47.7±13.2 (mean±SD with a DSM-IV diagnosis of schizophrenia or schizoaffective disorder who were admitted to six psychiatric hospitals from December 2013 to March 2014. We employed a 14-item questionnaire specifically developed to survey patients' attitudes toward placebo-controlled clinical trials.The results indicated that 33% of the patients would be willing to participate in a placebo-controlled clinical trial. Expectations for improvement of disease, a guarantee of hospital treatment continuation, and encouragement by family or friends were associated with the willingness to participate in such trials, whereas a belief of additional time required for medical examinations was associated with non-participation.Fewer than half of the respondents stated that they would be willing to participate in placebo-controlled clinical trials. Therefore, interpreting the results from placebo-controlled clinical trials could be negatively affected by selection bias.

A double-blind, placebo-controlled study of the safety and efficacy of ipratropium bromide nasal spray versus placebo in patients with the common cold.

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Dockhorn, R; Grossman, J; Posner, M; Zinny, M; Tinkleman, D

1992-12-01

Ipratropium bromide (IB) has been found to reduce secretions in the upper respiratory tract; this is accomplished through competitive inhibition of acetylcholine at muscarinic receptors that control rhinorrhea production. This study compared the safety and efficacy of IB with placebo in the symptomatic relief of rhinorrhea in patients with the common cold. Human subjects with symptoms of a common cold, primarily rhinorrhea, were enrolled and treated with either IB (84 micrograms/nostril) or placebo; each was administered as two sprays per nostril, four times a day, for 4 days. Primary efficacy analyses were in-clinic measurements of nasal discharge weights over a 3-hour period after administration on days 1 and 2 and assessment of rhinorrhea symptoms by use of a subjective patient-completed visual analog rating scale. IB significantly reduced rhinorrhea an average of 18% over placebo for days 1 and 2 (p = 0.01). Visual analog scale scores showed an average improvement in rhinorrhea of 22% over placebo (p = 0.001). When patients with relatively minor rhinorrhea (baseline weight of nasal discharge < or = 1.0 gm) were excluded, IB produced an average reduction in nasal discharge of 23% over placebo for days 1 and 2 (p = 0.003).

Catechol-O-methyltransferase val158met polymorphism predicts placebo effect in irritable bowel syndrome.

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Kathryn T Hall

Full Text Available Identifying patients who are potential placebo responders has major implications for clinical practice and trial design. Catechol-O-methyltransferase (COMT, an important enzyme in dopamine catabolism plays a key role in processes associated with the placebo effect such as reward, pain, memory and learning. We hypothesized that the COMT functional val158met polymorphism, was a predictor of placebo effects and tested our hypothesis in a subset of 104 patients from a previously reported randomized controlled trial in irritable bowel syndrome (IBS. The three treatment arms from this study were: no-treatment ("waitlist", placebo treatment alone ("limited" and, placebo treatment "augmented" with a supportive patient-health care provider interaction. The primary outcome measure was change from baseline in IBS-Symptom Severity Scale (IBS-SSS after three weeks of treatment. In a regression model, the number of methionine alleles in COMT val158met was linearly related to placebo response as measured by changes in IBS-SSS (p = .035. The strongest placebo response occurred in met/met homozygotes treated in the augmented placebo arm. A smaller met/met associated effect was observed with limited placebo treatment and there was no effect in the waitlist control. These data support our hypothesis that the COMT val158met polymorphism is a potential biomarker of placebo response.

Is placebo analgesia mediated by endogenous opioids? A systematic review

NARCIS (Netherlands)

ter Riet, G.; de Craen, A. J.; de Boer, Anthonius; Kessels, A. G.

1998-01-01

This systematic review assesses six experimental studies into the mechanism of placebo analgesia in human subjects suffering from clinical pain or experimentally induced ischaemic arm pain. Due to their sophisticated designs, these studies probably provide the best evidence that placebo analgesia

Clinical and ethical implications of placebo effects: enhancing patients' benefits from pain treatment.

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Klinger, Regine; Flor, Herta

2014-01-01

Expectancy and learning are the core psychological mechanisms of placebo analgesia. They interact with further psychological processes such as emotions and motivations (e.g., anxiety, desire for relief), somatic focus, or cognitions (e.g., attitudes toward the treatment). The development of placebo responsiveness and the actual placebo response in a person is the result of the complex interaction between factors traced back to the individual learning history related to analgesic drugs or treatments and factors of the current context referring to the analgesic or placebo treatment. The aim of this chapter is to depict these complex interactions in a new model of analgesic placebo effects. It joins aspects of the learning history (preexisting experiences and preexisting expectations) of a patient with aspects of the current context (current expectation as a result of external and internal situation in which a pain medication/treatment/placebo is taken, e.g., current information about pain medication, current specific context/cues, desire for pain relief, certainty about upcoming pain relief, current expectation about pain reducing course, current selective attention, increased pain experience, or decreased pain experience). In order to exploit placebo efficacy for an analgesic treatment it is worthwhile to assess in which direction each of these factors exerts its influence in order to maximize placebo effects for a specific patient. By applying placebo mechanisms in this differentiated way, the efficacy of pain treatment can be deliberately boosted.

Filtro respiratório reduz efeitos cardiovasculares associados à poluição: estudo randomizado, duplo-cego, controlado e cruzado em pacientes com insuficiência cardíaca (FILTER-HF trial)

OpenAIRE

Jefferson Luís Vieira

2016-01-01

Introdução A poluição do ar é um fator de risco associado com descompensação e mortalidade em pacientes com insuficiência cardíaca (IC). Objetivo Avaliar o impacto de um filtro de polipropileno sobre desfechos cardiovasculares em pacientes com IC e voluntários saudáveis durante exposição controlada à poluição. Métodos Ensaio clínico duplocego, controlado e cruzado, incluindo 26 pacientes com IC e 15 voluntários saudáveis, expostos a três protocolos diferentes de inalação randomizados por orde...

Ulipristal acetate versus placebo for fibroid treatment before surgery.

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Donnez, Jacques; Tatarchuk, Tetyana F; Bouchard, Philippe; Puscasiu, Lucian; Zakharenko, Nataliya F; Ivanova, Tatiana; Ugocsai, Gyula; Mara, Michal; Jilla, Manju P; Bestel, Elke; Terrill, Paul; Osterloh, Ian; Loumaye, Ernest

2012-02-02

The efficacy and safety of oral ulipristal acetate for the treatment of symptomatic uterine fibroids before surgery are uncertain. We randomly assigned women with symptomatic fibroids, excessive uterine bleeding (a score of >100 on the pictorial blood-loss assessment chart [PBAC, an objective assessment of blood loss, in which monthly scores range from 0 to >500, with higher numbers indicating more bleeding]) and anemia (hemoglobin level of ≤10.2 g per deciliter) to receive treatment for up to 13 weeks with oral ulipristal acetate at a dose of 5 mg per day (96 women) or 10 mg per day (98 women) or to receive placebo (48 women). All patients received iron supplementation. The coprimary efficacy end points were control of uterine bleeding (PBAC score of <75) and reduction of fibroid volume at week 13, after which patients could undergo surgery. At 13 weeks, uterine bleeding was controlled in 91% of the women receiving 5 mg of ulipristal acetate, 92% of those receiving 10 mg of ulipristal acetate, and 19% of those receiving placebo (P<0.001 for the comparison of each dose of ulipristal acetate with placebo). The rates of amenorrhea were 73%, 82%, and 6%, respectively, with amenorrhea occurring within 10 days in the majority of patients receiving ulipristal acetate. The median changes in total fibroid volume were -21%, -12%, and +3% (P=0.002 for the comparison of 5 mg of ulipristal acetate with placebo, and P=0.006 for the comparison of 10 mg of ulipristal acetate with placebo). Ulipristal acetate induced benign histologic endometrial changes that had resolved by 6 months after the end of therapy. Serious adverse events occurred in one patient during treatment with 10 mg of ulipristal acetate (uterine hemorrhage) and in one patient during receipt of placebo (fibroid protruding through the cervix). Headache and breast tenderness were the most common adverse events associated with ulipristal acetate but did not occur significantly more frequently than with placebo

Designing a placebo device: involving service users in clinical trial design.

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Gooberman-Hill, Rachael; Jinks, Clare; Bouças, Sofia Barbosa; Hislop, Kelly; Dziedzic, Krysia S; Rhodes, Carol; Burston, Amanda; Adams, Jo

2013-12-01

Service users are increasingly involved in the design of clinical trials and in product and device development. Service user involvement in placebo development is crucial to a credible and acceptable placebo for clinical trials, but such involvement has not yet been reported. To enhance the design of a future clinical trial of hand splints for thumb-base osteoarthritis (OA), service users were involved in splint selection and design of a placebo splint. This article describes and reflects on this process. Two fora of service users were convened in 2011. Service users who had been prescribed a thumb splint for thumb-base OA were approached about involvement by Occupational Therapy (OT) practitioners. A total of eight service users took part in the fora. Service users discussed their experience of OA and their own splints and then tried a variety of alternative splints. Through this they identified the active features of splints alongside acceptable and unacceptable design features. Service users focused on wearability and support with or without immobilization. Fora discussed whether a placebo group ('arm') was an acceptable feature of a future trial, and service users developed a potential design for a placebo splint. This is the first project that to involve service users in placebo design. Service users are increasingly involved in product and device design and are ideally placed to identify features to make a placebo credible yet lacking key active ingredients. The future trial will include research into its acceptability. © 2013 John Wiley & Sons Ltd.

Treatment satisfaction with tadalafil or tamsulosin vs placebo in men with lower urinary tract symptoms (LUTS) suggestive of benign prostatic hyperplasia (BPH): results from a randomised, placebo-controlled study.

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Oelke, Matthias; Giuliano, François; Baygani, Simin K; Melby, Thomas; Sontag, Angelina

2014-10-01

To assess treatment satisfaction with tadalafil or tamsulosin vs placebo in a 12-week, randomised, double-blind study of men with lower urinary tract symptoms suggestive of benign prostatic hyperplasia (LUTS/BPH). After a 4-week placebo lead-in period, men aged ≥45 years with an International Prostate Symptom Score (IPSS) of ≥13 and a maximum urinary flow rate of ≥4 to ≤15 mL/s received placebo (172 men), tadalafil 5 mg (171), or tamsulosin 0.4 mg (168) once daily for 12 weeks. Treatment Satisfaction Scale-BPH (TSS-BPH) responses were assessed based on median treatment differences using the van Elteren test. Overall treatment satisfaction was greater for tadalafil vs placebo (P = 0.005), based on greater satisfaction with efficacy (P = 0.003); neither overall treatment satisfaction nor satisfaction with efficacy was greater for tamsulosin vs placebo (P ≥ 0.409). For individual questions, 66.5% of men rated tadalafil treatment as 'effective/very effective' (Question 1, Q1) vs placebo (P = 0.011), 72.6% would 'definitely/probably recommend their treatment' (Q3; P = 0.043), 71.8% were generally 'very satisfied/satisfied with their medication' (Q8; P BPH by baseline age (≤65/>65 years), history of erectile dysfunction (yes/no), LUTS/BPH severity (IPSSplacebo, with only borderline difference for men without prior therapy. Treatment satisfaction was greater with tadalafil vs placebo, with no significant difference between tamsulosin and placebo. © 2014 The Authors. BJU International © 2014 BJU International.

Análisis no lineal de mallas espaciales de doble capa

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Estévez Cimadevila, Francisco Javier

1991-04-01

Full Text Available This paper is related to the topic developed in my RH.D. thesis. A new model is proposed to describe the non-linear behaviour of straight pin-jointed compression members. Sucti a method Is based upon obtaining the complete constitutive equations in the case of circular hollow sections. The stability functions of imperfect bars and the analytical formulation of the post-buckiing behaviour are obtained by taking the exact expression of the curvature in the integratlon of the differential equation of the elastic. The linearization of the constitutive relationships and the application of an incremental iterative model based upon the modification of the elasticity of the bars at critical point allows us to consider the non-linear analysis of the double layer space grids. The models of analysis proposed here have been applied to a wide variety of trusses with different characteristics and typologies, some examples of which accompany this paper.

Este artículo corresponde al tema de investigación desarrollado en mi tesis doctoral. Se plantea un nuevo modelo para describir el comportamiento no lineal de piezas rectas biarticuladas sometidas a compresión, basado en la obtención de las ecuaciones constitutivas en el caso de los perfiles tubulares huecos de sección circular. Se obtienen las funciones de estabilidad de barras imperfectas y la formulación analítica del comportamiento postpandeo tomando la expresión exacta de la curvatura en la integración de la ecuación diferencial de la elástica. La linearización de las leyes constitutivas y la aplicación de un modelo incremental Iterativo basado en la modificación del módulo de elasticidad de las barras en estado crítico permite abordar el análisis no lineal de las mallas espaciales de doble capa. Los modelos de análisis propuestos se aplicaron a una amplia variedad de mallas de diversas tipologías y características de las que se acompañan algunos ejemplos en el artículo.

Entre o Rio da Prata e os Andes no século XVIII: um percurso segundo análise do “Lazarillo de Ciegos Caminantes” = Between the Andes and River Plate in the eighteenth century: an analysis of "Lazarillo de Ciegos Caminantes"

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Cortes, Suéllen de Medeiros

2014-01-01

Full Text Available Este trabalho busca apresentar uma reflexão sobre as múltiplas possibilidades de interpretação e pesquisa sobre o processo de colonização hispânica na América, tendo como objeto de análise a obra “Lazarillo de Ciegos Caminhantes” de Don Alonso Carrió de la Vandera. O livro relata uma viajem a serviço da coroa espanhola, entre Buenos Aires e Lima, nos anos de 1771 e 1773 com a finalidade de colocar em prática algumas ações decorrentes das reformas bourbônicas. Contudo, o que era para ser apenas um documento administrativo, foi concebido de forma epistolar e em tom picaresco, podendo tornar-se também um guia a futuros viajantes. Tamanha singularidade não possibilita que a obra se classificada em uma única tipologia literária. Este “diário de viagem” é fonte primária quanto às demandas administrativas das regiões em questão e, sobretudo, do cotidiano das populações locais e a construção de uma nova cultura. Outro fato que se destaca é a abdicação de Carrió de la Vandera quanto da autoria do livro em nome de Concolorcorvo, um Inca que atuou como seu guia. Este fato permitiu uma diversidade de interpretações, sendo que grande parte equivocadas. A manipulação retórica, o emprego de ironias e anedotas, além de sua riqueza de detalhes sobre a caracterização e a constituição de uma cultura local o torna distinto dos demais guias elaborados no século XVIII. O autor jogando com estereótipos, apresenta características de uma cultura local diferenciada, especialmente no que diz respeito a peculiaridades da vida dos mestiços seminômades que viviam na região do Prata. Sua pluralidade, e suas possibilidades interdisciplinares, possibilitam-nos identificar o presente trabalho como um levantamento bibliográfico passível de ser referência de futuras pesquisas voltadas ao tema

ESTUDIO INTRAPAÍSES DE LA COMPETITIVIDAD GLOBAL DESDE EL ENFOQUE DEL DOBLE DIAMANTE PARA PUERTO RICO, COSTA RICA Y SINGAPUR

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Castro-Gonzáles, Segundo

2014-09-01

Full Text Available Muchos investigadores y economistas han argumentado que los estudios de competitividad del WEF e IMD muestran limitaciones en pequeñas economías,más aún cuando estas tienen características distintas. El objetivo de esta investigación es estudiar la competitividad de 3 peque˜nas economías: Puerto Rico, Costa Rica y Singapur. El modelo del doble-diamante de competitividad resulta útil a la hora de llevar a cabo esta tarea. La información procede de organismos internacionales. Los resultados muestran que Singapur goza de un mayor nivel de competitividad global comparado con Puerto Rico y Costa Rica. Concluimos que Puerto Rico y Costa Rica lucen equilibrados en competitividad, porque internacionalmente Puerto Rico aventaja a Costa Rica en 3 determinantes: condiciones de factores, condiciones de la demanda e industrias relacionadas y de apoyo; mientras que localmente Costa Rica es más competitivo que Puerto Rico en 3 factores domésticos: condiciones de factores, condiciones de demanda y estrategia de las firmas.

Ethical Overview of Placebo Control in Psychiatric Research - Concepts and Challenges.

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Ćurković, Marko; Živković, Maja; Radić, Krešimir; Vilibić, Maja; Ćelić, Ivan; Bagarić, Dario

2015-06-01

Permissibility of placebo controls in psychiatric research is raising everlasting controversies. The main ethical issue remains: whether, when, under what conditions, and to what extent is it justifiable to disregard subject's present (best) interest for the presumably "greater" ones. In relation to this main ethical concern, two distinct arguments arose: proponents of placebo controls trials (placebo ortxodoxy) and proponents of active controls trials (active-control orthodoxy). More recently, in new ethical guidelines, Declaration of Helsinki and International Ethical Guidelines for Biomedical Research Involving Human Subjects, a "middle way" approach was formulated, acceptable to both sides of the argument, saying placebo controls can be justified under certain conditions: when and only when, they firstly present undisputed methodological reasoning, and secondly, fulfill certain ethical considerations - mainly regarding the permissibility of accompanied risks. These ethical evaluations are inevitably contextual and evoke the need for the principle of proportionality. In scope of recent findings of substantial and progressively increasing placebo response in psychiatric research, contextual factors are identified and both theoretical and practical challenges are discussed.

Placebo use in the United kingdom: results from a national survey of primary care practitioners.

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Jeremy Howick

Full Text Available OBJECTIVES: Surveys in various countries suggest 17% to 80% of doctors prescribe 'placebos' in routine practice, but prevalence of placebo use in UK primary care is unknown. METHODS: We administered a web-based questionnaire to a representative sample of UK general practitioners. Following surveys conducted in other countries we divided placebos into 'pure' and 'impure'. 'Impure' placebos are interventions with clear efficacy for certain conditions but are prescribed for ailments where their efficacy is unknown, such as antibiotics for suspected viral infections. 'Pure' placebos are interventions such as sugar pills or saline injections without direct pharmacologically active ingredients for the condition being treated. We initiated the survey in April 2012. Two reminders were sent and electronic data collection closed after 4 weeks. RESULTS: We surveyed 1715 general practitioners and 783 (46% completed our questionnaire. Our respondents were similar to those of all registered UK doctors suggesting our results are generalizable. 12% (95% CI 10 to 15 of respondents used pure placebos while 97% (95% CI 96 to 98 used impure placebos at least once in their career. 1% of respondents used pure placebos, and 77% (95% CI 74 to 79 used impure placebos at least once per week. Most (66% for pure, 84% for impure respondents stated placebos were ethical in some circumstances. CONCLUSION AND IMPLICATIONS: Placebo use is common in primary care but questions remain about their benefits, harms, costs, and whether they can be delivered ethically. Further research is required to investigate ethically acceptable and cost-effective placebo interventions.

Triiodothyronine Administration in a Model of Septic Shock: A Randomized Blinded Placebo-Controlled Trial.

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Maiden, Matthew J; Chapman, Marianne J; Torpy, David J; Kuchel, Timothy R; Clarke, Iain J; Nash, Coralie H; Fraser, Jonathan D; Ludbrook, Guy L

2016-06-01

Triiodothyronine concentration in plasma decreases during septic shock and may contribute to multiple organ dysfunction. We sought to determine the safety and efficacy of administering triiodothyronine, with and without hydrocortisone, in a model of septic shock. Randomized blinded placebo-controlled trial. Preclinical research laboratory. Thirty-two sheep rendered septic with IV Escherichia coli and receiving protocol-guided sedation, ventilation, IV fluids, and norepinephrine infusion. Two hours following induction of sepsis, 32 sheep received a 24-hour IV infusion of 1) placebo + placebo, 2) triiodothyronine + placebo, 3) hydrocortisone + placebo, or 4) triiodothyronine + hydrocortisone. Primary outcome was the total amount of norepinephrine required to maintain a target mean arterial pressure; secondary outcomes included hemodynamic and metabolic indices. Plasma triiodothyronine levels increased to supraphysiological concentrations with hormonal therapy. Following 24 hours of study drug infusion, the amount of norepinephrine required was no different between the study groups (mean ± SD μg/kg; placebo + placebo group 208 ± 392; triiodothyronine + placebo group 501 ± 370; hydrocortisone + placebo group 167 ± 286; triiodothyronine + hydrocortisone group 466 ± 495; p = 0.20). There was no significant treatment effect on any hemodynamic variable, metabolic parameter, or measure of organ function. A 24-hour infusion of triiodothyronine, with or without hydrocortisone, in an ovine model of septic shock did not markedly alter norepinephrine requirement or any other physiological parameter.

UNA APROXIMACIÓN TEÓRICA A LA VALORACIÓN DEL DOBLE AJUSTE EN EL DISEÑO DE LA ESTRATEGIA DE RECURSOS HUMANOS

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García Carbonell, Natalia

2013-05-01

Full Text Available Tradicionalmente la literatura ha considerado la necesidad del doble ajuste, vertical y horizontal, de la estrategia de recursos humanos en las organizaciones. Su importancia estratégica ha sido demostrada en buena parte de los estudios empíricos planteados. Sin embargo, la complejidad de este proceso requiere de un análisis más profundo que permita identificar los elementos que lo hacen posible. En el presente trabajo, partiendo de la revisión de la literatura de las perspectivas de investigación en dirección estratégica de recursos humanos y del concepto «fortaleza del sistema de recursos humanos» propuesto por Bowen y Ostroff (2004, discutimos los 3 factores que integran dicho concepto y su relación con el ajuste del sistema. Como consecuencia de ello, definimos 3 proposiciones teóricas que explican la vinculación entre ambas dimensiones y la fortaleza del sistema.

Placebo-mediated, Naloxone-sensitive suggestibility of short-term memory performance.

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Stern, Jair; Candia, Victor; Porchet, Roseline I; Krummenacher, Peter; Folkers, Gerd; Schedlowski, Manfred; Ettlin, Dominik A; Schönbächler, Georg

2011-03-01

Physiological studies of placebo-mediated suggestion have been recently performed beyond their traditional clinical context of pain and analgesia. Various neurotransmitter systems and immunological modulators have been used in successful placebo suggestions, including Dopamine, Cholecystokinin and, most extensively, opioids. We adhered to an established conceptual framework of placebo research and used the μ-opioid-antagonist Naloxone to test the applicability of this framework within a cognitive domain (e.g. memory) in healthy volunteers. Healthy men (n=62, age 29, SD=9) were required to perform a task-battery, including standardized and custom-designed memory tasks, to test short-term recall and delayed recognition. Tasks were performed twice, before and after intravenous injection of either NaCl (0.9%) or Naloxone (both 0.15 mg/kg), in a double-blind setting. While one group was given neutral information (S-), the other was told that it might receive a drug with suspected memory-boosting properties (S+). Objective and subjective indexes of memory performance and salivary cortisol (as a stress marker) were recorded during both runs and differences between groups were assessed. Short-term memory recall, but not delayed recognition, was objectively increased after placebo-mediated suggestion in the NaCl-group. Naloxone specifically blocked the suggestion effect without interfering with memory performance. These results were not affected when changes in salivary cortisol levels were considered. No reaction time changes, recorded to uncover unspecific attentional impairment, were seen. Placebo-mediated suggestion produced a training-independent, objective and Naloxone-sensitive increase in memory performance. These results indicate an opioid-mediated placebo effect within a circumscribed cognitive domain in healthy volunteers. Copyright © 2011 Elsevier Inc. All rights reserved.

Segregating the cerebral mechanisms of antidepressants and placebo in fibromyalgia.

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Jensen, Karin B; Petzke, Frank; Carville, Serena; Choy, Ernest; Fransson, Peter; Gracely, Richard H; Vitton, Olivier; Marcus, Hanke; Williams, Steven C R; Ingvar, Martin; Kosek, Eva

2014-12-01

Antidepressant drugs are commonly used to treat fibromyalgia, but there is little knowledge about their mechanisms of action. The aim of this study was to compare the cerebral and behavioral response to positive treatment effects of antidepressants or placebo. Ninety-two fibromyalgia patients participated in a 12-week, double-blind, placebo-controlled clinical trial with milnacipran, a serotonin-norepinephrine reuptake inhibitor. Before and after treatment, measures of cerebral pain processing were obtained using functional magnetic resonance imaging. Also, there were stimulus response assessments of pressure pain, measures of weekly pain, and fibromyalgia impact. Following treatment, milnacipran responders exhibited significantly higher activity in the posterior cingulum compared with placebo responders. The mere exposure to milnacipran did not explain our findings because milnacipran responders exhibited increased activity also in comparison to milnacipran nonresponders. Stimulus response assessments revealed specific antihyperalgesic effects in milnacipran responders, which was also correlated with reduced clinical pain and with increased activation of the posterior cingulum. A short history of pain predicted positive treatment response to milnacipran. We report segregated neural mechanisms for positive responses to treatment with milnacipran and placebo, reflected in the posterior cingulum. The increase of pain-evoked activation in the posterior cingulum may reflect a normalization of altered default mode network processing, an alteration implicated in fibromyalgia pathophysiology. This study presents neural and psychophysical correlates to positive treatment responses in patients with fibromyalgia, treated with either milnacipran or placebo. The comparison between placebo responders and milnacipran responders may shed light on the specific mechanisms involved in antidepressant treatment of chronic pain. Copyright © 2014 American Pain Society. Published by

A Machine Learning Approach to Identifying Placebo Responders in Late-Life Depression Trials.

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Zilcha-Mano, Sigal; Roose, Steven P; Brown, Patrick J; Rutherford, Bret R

2018-01-11

Despite efforts to identify characteristics associated with medication-placebo differences in antidepressant trials, few consistent findings have emerged to guide participant selection in drug development settings and differential therapeutics in clinical practice. Limitations in the methodologies used, particularly searching for a single moderator while treating all other variables as noise, may partially explain the failure to generate consistent results. The present study tested whether interactions between pretreatment patient characteristics, rather than a single-variable solution, may better predict who is most likely to benefit from placebo versus medication. Data were analyzed from 174 patients aged 75 years and older with unipolar depression who were randomly assigned to citalopram or placebo. Model-based recursive partitioning analysis was conducted to identify the most robust significant moderators of placebo versus citalopram response. The greatest signal detection between medication and placebo in favor of medication was among patients with fewer years of education (≤12) who suffered from a longer duration of depression since their first episode (>3.47 years) (B = 2.53, t(32) = 3.01, p = 0.004). Compared with medication, placebo had the greatest response for those who were more educated (>12 years), to the point where placebo almost outperformed medication (B = -0.57, t(96) = -1.90, p = 0.06). Machine learning approaches capable of evaluating the contributions of multiple predictor variables may be a promising methodology for identifying placebo versus medication responders. Duration of depression and education should be considered in the efforts to modulate placebo magnitude in drug development settings and in clinical practice. Copyright © 2018 American Association for Geriatric Psychiatry. Published by Elsevier Inc. All rights reserved.

Placebo Mechanisms of Manual Therapy: A Sheep in Wolf's Clothing?

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Bialosky, Joel E; Bishop, Mark D; Penza, Charles W

2017-05-01

When a physical therapist provides a manual therapy (MT) intervention for a patient presenting with pain and the patient experiences a positive clinical outcome, we cannot answer as to why this occurs. Would we continue to devote valuable time and financial resources to learning and improving our skills in providing MT interventions if the related clinical outcomes were placebo responses? In this Viewpoint, the authors conceptualize placebo as an active and important mechanism of MT and argue that placebo mechanisms deserve consideration as an important component of the treatment effect. J Orthop Sports Phys Ther 2017;47(5):301-304. doi:10.2519/jospt.2017.0604.

Double-Blind, Placebo-Controlled, Randomized Trial of Selenium in Graves Hyperthyroidism.

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Kahaly, George J; Riedl, Michaela; König, Jochem; Diana, Tanja; Schomburg, Lutz

2017-11-01

Supplemental selenium (Se) may affect the clinical course of Graves disease (GD). Evaluate efficacy of add-on Se on medical treatment in GD. Double-blind, placebo-controlled, randomized supplementation trial. Academic endocrine outpatient clinic. Seventy untreated hyperthyroid patients with GD. Additionally to methimazole (MMI), patients received for 24 weeks either sodium selenite 300 µg/d po or placebo. MMI was discontinued at 24 weeks in euthyroid patients. Response rate (week 24), recurrence rate (week 36), and safety. A response was registered in 25 of 31 patients (80%) and in 27 of 33 (82%) at week 24 [odds ratio (OR) 0.93; 95% confidence interval (CI), 0.26 to 3.25; P = 0.904] in the Se (+MMI) and placebo (+MMI) groups, respectively. During a 12-week follow-up, 11 of 23 (48%) and 12 of 27 (44%) relapsed (OR 1.13; 95% CI, 0.29 to 2.66; P = 0.81) in the Se and placebo groups, respectively. Serum concentrations of Se and selenoprotein P were unrelated to response or recurrence rates. At week 36, 12 of 29 (41%) and 15 of 33 (45%) were responders and still in remission in the Se and placebo groups, respectively (OR 0.85; 95% CI, 0.31 to 2.32; P = 0.80). Serum levels of free triiodothyronine/free tetraiodothyronine, thyroid-stimulating hormone receptor antibody, prevalence of moderate to severe Graves orbitopathy, thyroid volume, and MMI starting dose were significantly lower in responders than in nonresponders. A total of 56 and 63 adverse events occurred in the Se and placebo groups, respectively (P = 0.164), whereas only one drug-related side effect (2.9%) was noted in 35 patients on placebo + MMI. Supplemental Se did not affect response or recurrence rates in GD. Copyright © 2017 Endocrine Society

Physical dependence increases the relative reinforcing effects of caffeine versus placebo.

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Garrett, B E; Griffiths, R R

1998-10-01

Using a within-subject cross-over design, this study examined the role of physical dependence in caffeine reinforcement by experimentally manipulating physical dependence. Each subject was exposed to two chronic drug phases (300 mg/70 kg/day caffeine and placebo) for 9-12 days, with order of phases counterbalanced across subjects. On 2 separate days immediately following each of the chronic drug exposures, subjects received acute doses of either caffeine (300 mg/70 kg) or placebo in counterbalanced order. The reinforcing effects of these drugs were then determined by using a multiple-choice procedure in which subjects made a series of discrete choices between receiving varying amounts of money or receiving the drug again, and a choice between the two drugs. To ensure that subjects completed the form carefully, following exposure to both of the acute drug administrations, one of the subject's previous choices from the multiple-choice form was randomly selected and the consequence of that choice was implemented. When subjects were maintained on chronic caffeine, they were willing to forfeit significantly more money and showed significant increases in typical withdrawal symptoms (e.g. fatigue, mood disturbance) after receiving placebo as compared to the other three conditions. When subjects were maintained on chronic caffeine, they also chose to receive caffeine over placebo twice as often than when they were maintained on chronic placebo. These findings provide the strongest evidence to date indicating that caffeine physical dependence increases the relative reinforcing effects of caffeine versus placebo.

Declining efficacy in controlled trials of antidepressants: effects of placebo dropout

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Schalkwijk, S.J.; Undurraga, J.; Tondo, L.; Baldessarini, R.J.

2014-01-01

Drug-placebo differences (effect-sizes) in controlled trials of antidepressants for major depressive episodes have declined for several decades, in association with selectively increasing clinical improvement associated with placebo-treatment. As these trends require adequate explanation, we tested

Alterações hemodinâmicas durante o pneumoperitônio em cães ventilados com volume e pressão controlados Alteraciones hemodinámicas durante el pneumoperitoneo en canes ventilados con volumen y presión controlados Hemodynamic changes during pneumoperitoneum in volume and pressure controlled ventilated dogs

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Armando Vieira de Almeida

2003-12-01

Full Text Available JUSTIFICATIVA E OBJETIVOS: Não existem estudos que associem os efeitos determinados pelas modalidades ventilatórias às repercussões hemodinâmicas durante o pneumoperitônio. O objetivo deste estudo foi avaliar as alterações na hemodinâmica determinadas pelo pneumoperitônio em cães com ventilação por volume e pressão controlados. MÉTODO: Dezesseis cães anestesiados com tiopental sódico e fentanil foram divididos em grupo 1, volume controlado, e grupo 2, pressão controlada, e submetidos ao pneumoperitônio de 10 e 15 mmHg. Foram estudados freqüência cardíaca, pressão arterial média, pressão de átrio direito, pressão de artéria pulmonar ocluída, índice cardíaco, índice de resistência vascular sistêmica e vasopressina plasmática. Os dados foram coletados em 4 momentos. M1 - antes do pneumoperitônio, M2 - 30 minutos após pneumoperitônio com 10 mmHg, M3 - 30 minutos após pneumoperitônio com 15 mmHg, M4 - 30 minutos após a deflação do pneumoperitônio. RESULTADOS: Os resultados mostraram aumento no índice cardíaco, nas pressões de átrio direito e de artéria pulmonar ocluída em M2 e M3, em ambos os grupos. A vasopressina não variou durante o procedimento e o índice de resistência vascular sistêmica não aumentou, proporcionando estabilidade da pressão arterial média em ambos os grupos. CONCLUSÕES: As modalidades ventilatórias não determinaram diferenças na resposta hemodinâmica entre os grupos estudados. A técnica anestésica utilizada e as pressões intra-abdominais alcançadas determinaram estabilidade da pressão arterial média, provavelmente decorrente da ausência do aumento no índice da resistência vascular sistêmica.JUSTIFICATIVA Y OBJETIVOS: No existen estudios que asocien los efectos determinados por las modalidades ventilatorias a las repercusiones hemodinámicas durante el pneumoperitoneo. El objetivo de este estudio fue evaluar las alteraciones en la hemodinámica determinadas

Adherence to placebo and mortality in the Beta Blocker Evaluation of Survival Trial (BEST).

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Pressman, Alice; Avins, Andrew L; Neuhaus, John; Ackerson, Lynn; Rudd, Peter

2012-05-01

Randomized controlled trials have reported lower mortality among patients who adhere to placebo compared with those who do not. We explored this phenomenon by reanalyzing data from the placebo arm of the Beta Blocker Evaluation of Survival Trial (BEST), a randomized, double-blind, placebo-controlled trial of bucindolol and mortality. Our primary aim was to measure and explain the association between adherence to placebo and total mortality among the placebo-allocated participants in the BEST trial. Secondary aims included assessment of the association between placebo adherence and cause-specific mortality. Participants with "higher placebo adherence" were defined as having taken at least 75% of their placebo study medication over the entire course of each individual's participation in the study, while those with "lower placebo adherence" took <75%. Primary outcome was in-study all-cause mortality. To account for confounding, we adjusted for all available modifiable, non-modifiable and psychosocial variables. Adherent participants had a significantly lower total mortality compared to less-adherent participants (HR=0.61, 95% Confidence Interval: 0.46-0.82). Adjusting for available confounders did not change the magnitude or significance of the estimates. When considering cause-specific mortality, CVD and pump failure showed similar associations. Analyses of the BEST trial data support a strong association between adherence to placebo study medication and total mortality. While probably not due to publication bias or simple confounding by healthy lifestyle factors, the underlying explanation for the association remains a mystery. Prospective examination of this association is necessary to better understand the underlying mechanism of this observation. Copyright © 2012 Elsevier Inc. All rights reserved.

Mechanisms of placebo analgesia: A dual-process model informed by insights from cross-species comparisons.

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Schafer, Scott M; Geuter, Stephan; Wager, Tor D

2018-01-01

Placebo treatments are pharmacologically inert, but are known to alleviate symptoms across a variety of clinical conditions. Associative learning and cognitive expectations both play important roles in placebo responses, however we are just beginning to understand how interactions between these processes lead to powerful effects. Here, we review the psychological principles underlying placebo effects and our current understanding of their brain bases, focusing on studies demonstrating both the importance of cognitive expectations and those that demonstrate expectancy-independent associative learning. To account for both forms of placebo analgesia, we propose a dual-process model in which flexible, contextually driven cognitive schemas and attributions guide associative learning processes that produce stable, long-term placebo effects. According to this model, the placebo-induction paradigms with the most powerful effects are those that combine reinforcement (e.g., the experience of reduced pain after placebo treatment) with suggestions and context cues that disambiguate learning by attributing perceived benefit to the placebo. Using this model as a conceptual scaffold, we review and compare neurobiological systems identified in both human studies of placebo analgesia and behavioral pain modulation in rodents. We identify substantial overlap between the circuits involved in human placebo analgesia and those that mediate multiple forms of context-based modulation of pain behavior in rodents, including forebrain-brainstem pathways and opioid and cannabinoid systems in particular. This overlap suggests that placebo effects are part of a set of adaptive mechanisms for shaping nociceptive signaling based on its information value and anticipated optimal response in a given behavioral context. Copyright © 2017 Elsevier Ltd. All rights reserved.

Reconstrucción de rodilla con doble colgajo de gemelo Knee reconstruction with double gemelar muscular flap

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C. Márquez Zevallos

2011-06-01

Full Text Available Los traumatismos de miembros inferior representan un reto importante para el cirujano plástico en cuanto a su reconstrucción cuando no se dispone de técnicas microquirúrgicas. En el presente trabajo se presentan 2 casos de reconstrucción de rodilla con doble colgajo muscular de gemelo, en los que se demuestra que se pueden utilizar simultáneamente los dos gemelos sin dejar ninguna secuela estética importante ni funcional en la deambulación de los pacientes. Hasta donde podemos conocer, no existe en la literatura nacional ni internacional un reporte de casos con esta aplicación, ya que siempre se ha empelado un solo músculo precisamente por el temor a alterar la función de flexo-extensión del pie.Lower limb traumatism has always been a problem for plastic surgeon when in the moment of the surgical reconstruction we have not microsurgical techniques. In this paper, we present 2 cases of knee reconstruction using a double gemelar muscular flap, showing how is possible the simultaneous use of the two muscles without aesthetic or functional sequels. As we know, there is no national or international report of cases with this muscular reconstruction; it has been usual to use only one muscle, in order to avoid problems in the flexo-extension movements of the foot.

Ensaio clínico duplo-cego randomizado e placebocontrolado com naltrexona e intervenção breve no tratamento ambulatorial da dependência de álcool A double blind, randomized and placebo-controlled clinical trial with naltrexone and brief intervention in outpatient treatment of alcohol dependence

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Luís André Castro

2009-01-01

Full Text Available OBJETIVO: O objetivo deste estudo é avaliar a eficácia da naltrexona com intervenção breve em pacientes com dependência de álcool. MÉTODO: Este estudo é um ensaio clínico randomizado, duplo-cego, placebo-controlado de 12 semanas. A amostra de 71 pacientes foi dividida randomicamente em dois grupos (um recebendo naltrexona e outro placebo. Sujeitos dependentes de álcool foram tratados com 50 mg de naltrexona ou placebo diariamente por 12 semanas. Ambos os grupos de tratamento receberam intervenção breve. Os desfechos clínicos primários para este estudo foram taxa de recaída e mudança no padrão de consumo de álcool. RESULTADOS: Na intenção de tratar, menor porcentagem de sujeitos tratados com naltrexona recaíram (3% 21%; p = 0,054. Naltrexona com intervenção breve não foi superior ao placebo para diminuir os dias de consumo (6,2 + 10,6 3,05 + 7,3; p = 0,478, os dias de consumo moderado (0 2,2 + 6,9; p = 0,345 e os dias de consumo pesado (0,03 + 0,2 0,3 + 0,9; p = 0,887. Naltrexona foi bem tolerada. Os efeitos adversos mais frequentes na presente amostra foram: cefaleia (25,4%, sonolência (20,9%, náuseas (16,4%, hiperfagia (16,4%, anorexia (14,9%, ansiedade (10,4%, pirose (10,4% e irritabilidade (10,4%. CONCLUSÕES: Embora o grupo naltrexona tenha demonstrado tendência para reduzir taxa de recaída (> 5 doses/dia, não foi encontrada nenhuma diferença em outras variáveis de consumo de álcool entre os grupos naltrexona e placebo. Estudos futuros devem examinar a eficácia desse tipo de combinação de tratamento nos cuidados primários de saúde.OBJECTIVE: The objective of this study is to evaluate the efficacy of naltrexone with brief intervention among patients with alcohol dependence. METHOD: This study is a 12-week randomized, double blind, placebo-controlled clinical trial. The sample of 71 patients was randomly divided in two groups (one receiving naltrexone and the other placebo. Alcohol-dependent subjects were

The therapeutic effect of clinical trials: understanding placebo response rates in clinical trials – A secondary analysis

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Walach Harald

2005-08-01

Full Text Available Abstract Background and purpose Placebo response rates in clinical trials vary considerably and are observed frequently. For new drugs it can be difficult to prove effectiveness superior to placebo. It is unclear what contributes to improvement in the placebo groups. We wanted to clarify, what elements of clinical trials determine placebo variability. Methods We analysed a representative sample of 141 published long-term trials (randomized, double-blind, placebo-controlled; duration > 12 weeks to find out what study characteristics predict placebo response rates in various diseases. Correlational and regression analyses with study characteristics and placebo response rates were carried out. Results We found a high and significant correlation between placebo and treatment response rate across diseases (r = .78; p Conclusion Medication response rates and placebo response rates in clinical trials are highly correlated. Trial characteristics can explain some portion of the variance in placebo healing rates in RCTs. Placebo response in trials is only partially due to methodological artefacts and only partially dependent on the diagnoses treated.

The challenge of recruiting patients into a placebo-controlled surgical trial

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Hare, Kristoffer B; Lohmander, L Stefan; Roos, Ewa M.

2014-01-01

BACKGROUND: Randomized placebo-controlled trials represent the gold standard in evaluating healthcare interventions but are rarely performed within orthopedics. Ethical concerns or well-known challenges in recruiting patients for surgical trials in general have been expressed and adding a placebo...

Another face of placebo: The lessebo effect in Parkinson disease

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Mestre, Tiago A.; Shah, Prakesh; Marras, Connie; Tomlinson, George

2014-01-01

Objective: To study the impact of negative expectation related to receiving a placebo (the “lessebo effect”) on efficacy outcome measures of symptomatic treatments in Parkinson disease (PD). Methods: We conducted meta-analyses of double-blind randomized controlled trials (RCTs) of dopamine agonists in PD and compared the pooled mean score change of the motor section of the Unified Parkinson's Disease Rating Scale (mUPDRS) across active treatment arms according to the presence of a placebo arm or the probability of placebo assignment (0%, <50%, and 50%) of the original RCT. A mixed-effects model was used. Heterogeneity was assessed by subgroup analyses and meta-regression modeling. Results: A total of 28 study arms were extracted from active-controlled trials (3,277 patients) and 42 from placebo-controlled trials (4,554 patients). The overall difference between groups in the pooled mean score change in the mUPDRS was 1.6 units (95% confidence interval [CI] 0.2, 3.0; p = 0.023), in favor of the active-controlled group. In subgroup analyses, this difference was of higher magnitude in the early PD group without motor fluctuations (3.3 mUPDRS units, 95% CI 1.1, 5.4; p = 0.003) and for study duration ≤12 weeks (4.1 mUPDRS units, 95% CI 1.0, 7.2; p = 0.009). There was no between-group difference using probability of placebo assignment as criterion. Conclusions: This study shows that the use of a placebo can be associated with a clinically significant reduction in the magnitude of change of the mUPDRS after an active treatment in RCTs for PD. These new findings have potential implications in the development of new treatments and appraisal of current treatment options for PD and possibly for other neurologic disorders. PMID:24658930

Acute psychological benefits of exercise: reconsideration of the placebo effect.

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Szabo, Attila

2013-10-01

The psychological benefits of exercise are repeatedly and consistently reported in the literature. Various forms of exercise, varying in duration and intensity, yield comparably positive changes in affect, which sheds doubt on the significance of exercise characteristics in the acute mental health benefits resulting from physical activity. Based on research evidence, it is argued that the placebo effect may play a key role in the subjective exercise experience. This report is aimed at highlighting those aspects of the extant literature that call for the reconsideration of the placebo effect in the understanding of the acute mental benefits of physical activity. This narrative review focuses on research evidence demonstrating that the duration and intensity of physical activity are not mediatory factors in the mental health benefits of acute exercise. Current research evidence pointing to the roles of expectancy and conditioning in the affective benefits of exercise calls for the reconsideration of the placebo effect. The present evaluation concludes that new research effort ought to be invested in the placebo-driven affective beneficence of exercise.

A placebo-controlled trial of itopride in functional dyspepsia.

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Holtmann, Gerald; Talley, Nicholas J; Liebregts, Tobias; Adam, Birgit; Parow, Christopher

2006-02-23

The treatment of patients with functional dyspepsia remains unsatisfactory. We assessed the efficacy of itopride, a dopamine D2 antagonist with anti-acetylcholinesterase [corrected] effects, in patients with functional dyspepsia. Patients with functional dyspepsia were randomly assigned to receive either itopride (50, 100, or 200 mg three times daily) or placebo. After eight weeks of treatment, three primary efficacy end points were analyzed: the change from baseline in the severity of symptoms of functional dyspepsia (as assessed by the Leeds Dyspepsia Questionnaire), patients' global assessment of efficacy (the proportion of patients without symptoms or with marked improvement), and the severity of pain or fullness as rated on a five-grade scale. We randomly assigned 554 patients; 523 had outcome data and could be included in the analyses. After eight weeks, 41 percent of the patients receiving placebo were symptom-free or had marked improvement, as compared with 57 percent, 59 percent, and 64 percent receiving itopride at a dose of 50, 100, or 200 mg three times daily, respectively (Pitopride). Although the symptom score improved significantly in all four groups, an overall analysis revealed that itopride was significantly superior to placebo, with the greatest symptom-score improvement in the 100- and 200-mg groups (-6.24 and -6.27, vs. -4.50 in the placebo group; P=0.05). Analysis of the combined end point of pain and fullness showed that itopride yielded a greater rate of response than placebo (73 percent vs. 63 percent, P=0.04). Itopride significantly improves symptoms in patients with functional dyspepsia. (ClinicalTrials.gov number, NCT00272103.). Copyright 2006 Massachusetts Medical Society.

Placebo-suggestion modulates conflict resolution in the Stroop Task.

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Pedro A Magalhães De Saldanha da Gama

Full Text Available Here, we ask whether placebo-suggestion (without any form of hypnotic induction can modulate the resolution of cognitive conflict. Naïve participants performed a Stroop Task while wearing an EEG cap described as a "brain wave" machine. In Experiment 1, participants were made to believe that the EEG cap would either enhance or decrease their color perception and performance on the Stroop task. In Experiment 2, participants were explicitly asked to imagine that their color perception and performance would be enhanced or decreased (non-hypnotic imaginative suggestion. We observed effects of placebo-suggestion on Stroop interference on accuracy: interference was decreased with positive suggestion and increased with negative suggestion compared to baseline. Intra-individual variability was also increased under negative suggestion compared to baseline. Compliance with the instruction to imagine a modulation of performance, on the other hand, did not influence accuracy and only had a negative impact on response latencies and on intra-individual variability, especially in the congruent condition of the Stroop Task. Taken together, these results demonstrate that expectations induced by a placebo-suggestion can modulate our ability to resolve cognitive conflict, either facilitating or impairing response accuracy depending on the suggestion's contents. Our results also demonstrate a dissociation between placebo-suggestion and non-hypnotic imaginative suggestion.

Placebo effect studies are susceptible to response bias and to other types of biases

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Hróbjartsson, Asbjørn; Kaptchuk, Ted J; Miller, Franklin G

2011-01-01

Investigations of the effect of placebo are often challenging to conduct and interpret. The history of placebo shows that assessment of its clinical significance has a real potential to be biased. We analyze and discuss typical types of bias in studies on placebo....

Double-blind clonazepam vs placebo in panic disorder treatment

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VALENÇA ALEXANDRE MARTINS

2000-01-01

Full Text Available OBJECTIVE: To assess the effectiveness of clonazepam, in a fixed dose (2 mg/day, compared with placebo in the treatment of panic disorder patients. METHOD: 24 panic disorder patients with agoraphobia were randomly selected. The diagnosis was obtained using the structured clinical interview for DSM-IV . All twenty-four subjects were randomly assigned to either treatment with clonazepam (2 mg/day or placebo, during 6 weeks. Efficacy assessments included: change from baseline in the number of panic attacks; CGI scores for panic disorder; Hamilton rating scale for anxiety; and panic associated symptoms scale. RESULTS: At the therapeutic endpoint, only one of 9 placebo patients (11.1% were free of panic attacks, compared with 8 of 13 (61.5% clonazepam patients (Fisher exact test; p=0,031. CONCLUSION: the results provide evidence for the efficacy of clonazepam in panic disorder patients.

Ayudas externas para mejorar la independencia en personas con discapacidad visual

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Héctor Darío Escobar Gómez

Full Text Available En los últimos años se ha incrementado la investigación con respecto al desarrollo de ayudas que mejoren la independencia de los discapacitados visuales. El propósito de esta revisión es determinar la evidencia científica relacionada con ayudas externas para mejorar la independencia en personas con discapacidad visual severa o ceguera. Para efectuar el trabajo fueron consultadas las bases de datos de PubMed, Cochrane Database-Wiley Online Library, LILACS y Scielo, además de las publicaciones de la Organización Mundial de la Salud, el Instituto Nacional de Ciegos en Colombia, el Consejo Internacional de Oftalmología y los patrones preferidos de práctica en rehabilitación visual, de la Academia Americana de Oftalmología. Se incluyó un total de 43 artículos y documentos en los idiomas inglés, portugués y español para ser analizados. La mayoría de estos estudios fueron descriptivos, y no se encontraron ensayos controlados ni metanálisis. La tendencia observada es hacia ayudas tecnológicas con un diseño dirigido al usuario y cada vez más pequeñas, discretas, con múltiples funciones que comprenden sus actividades de la vida diaria.

The placebo effect and its determinants in fibromyalgia: meta-analysis of randomised controlled trials.

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Chen, Xi; Zou, Kun; Abdullah, Natasya; Whiteside, Nicola; Sarmanova, Aliya; Doherty, Michael; Zhang, Weiya

2017-07-01

The aims of this study were to determine whether placebo treatment in randomised controlled trials (RCTs) is effective for fibromyalgia and to identify possible determinants of the magnitude of any such placebo effect. A systematic literature search was undertaken for RCTs in people with fibromyalgia that included a placebo and/or a no-treatment (observation only or waiting list) control group. Placebo effect size (ES) for pain and other outcomes was measured as the improvement of each outcome from baseline divided by the standard deviation of the change from baseline. This effect was compared with changes in the no-treatment control groups. Meta-analysis was undertaken to combine data from different studies. Subgroup analysis was conducted to identify possible determinants of the placebo ES. A total of 3912 studies were identified from the literature search. After scrutiny, 229 trials met the inclusion criteria. Participants who received placebo in the RCTs experienced significantly better improvements in pain, fatigue, sleep quality, physical function, and other main outcomes than those receiving no treatment. The ES of placebo for pain relief was clinically moderate (0.53, 95%CI 0.48 to 0.57). The ES increased with increasing strength of the active treatment, increasing participant age and higher baseline pain severity, but decreased in RCTS with more women and with longer duration of fibromyalgia. In addition, placebo treatment in RCTs is effective in fibromyalgia. A number of factors (expected strength of treatment, age, gender, disease duration) appear to influence the magnitude of the placebo effect in this condition.

Randomized, Multicenter, Placebo-Controlled Clinical Trial of Duloxetine Versus Placebo for Aromatase Inhibitor-Associated Arthralgias in Early-Stage Breast Cancer: SWOG S1202.

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Henry, N Lynn; Unger, Joseph M; Schott, Anne F; Fehrenbacher, Louis; Flynn, Patrick J; Prow, Debra M; Sharer, Carl W; Burton, Gary V; Kuzma, Charles S; Moseley, Anna; Lew, Danika L; Fisch, Michael J; Moinpour, Carol M; Hershman, Dawn L; Wade, James L

2018-02-01

Purpose Adherence to aromatase inhibitor (AI) therapy for early-stage breast cancer is limited by AI-associated musculoskeletal symptoms (AIMSS). Duloxetine is US Food and Drug Administration approved for treatment of multiple chronic pain disorders. We hypothesized that treatment of AIMSS with duloxetine would improve average joint pain compared with placebo. Methods This randomized, double-blind, phase III trial included AI-treated postmenopausal women with early-stage breast cancer and who had average joint pain score of ≥ 4 out of 10 that developed or worsened since AI therapy initiation. Patients were randomly assigned 1:1 to duloxetine or placebo for 13 weeks. The primary end point was average joint pain through 12 weeks, examined using multivariable linear mixed models, adjusted for stratification factors (baseline pain score of 4 to 6 v 7 to 10 and prior taxane use). Clinically significant change in average pain was defined as a ≥ 2-point decrease from baseline. Results Of 299 enrolled patients, 127 patients treated with duloxetine and 128 who received placebo were evaluable for the primary analysis. By 12 weeks, the average joint pain score was 0.82 points lower for patients who received duloxetine compared with those who received placebo (95% CI, -1.24 to -0.40; P = .0002). Similar patterns were observed for worst joint pain, joint stiffness, pain interference, and functioning. Rates of adverse events of any grade were higher in the duloxetine-treated group (78% v 50%); rates of grade 3 adverse events were similar. Conclusion Results of treatment with duloxetine for AIMSS were superior to those of placebo among women with early-stage breast cancer, although it resulted in more frequent low-grade toxicities.

Developing a placebo-controlled trial in surgery: issues of design, acceptability and feasibility.

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Campbell, M K; Entwistle, V A; Cuthbertson, B H; Skea, Z C; Sutherland, A G; McDonald, A M; Norrie, J D; Carlson, R V; Bridgman, S

2011-02-21

Surgical placebos are controversial. This in-depth study explored the design, acceptability, and feasibility issues relevant to designing a surgical placebo-controlled trial for the evaluation of the clinical and cost effectiveness of arthroscopic lavage for the management of people with osteoarthritis of the knee in the UK. Two surgeon focus groups at a UK national meeting for orthopaedic surgeons and one regional surgeon focus group (41 surgeons); plenary discussion at a UK national meeting for orthopaedic anaesthetists (130 anaesthetists); three focus groups with anaesthetists (one national, two regional; 58 anaesthetists); two focus groups with members of the patient organisation Arthritis Care (7 participants); telephone interviews with people on consultant waiting lists from two UK regional centres (15 participants); interviews with Chairs of UK ethics committees (6 individuals); postal surveys of members of the British Association of Surgeons of the Knee (382 surgeons) and members of the British Society of Orthopaedic Anaesthetists (398 anaesthetists); two centre pilot (49 patients assessed). There was widespread acceptance that evaluation of arthroscopic lavage had to be conducted with a placebo control if scientific rigour was not to be compromised. The choice of placebo surgical procedure (three small incisions) proved easier than the method of anaesthesia (general anaesthesia). General anaesthesia, while an excellent mimic, was more intrusive and raised concerns among some stakeholders and caused extensive discussion with local decision-makers when seeking formal approval for the pilot.Patients were willing to participate in a pilot with a placebo arm; although some patients when allocated to surgery became apprehensive about the possibility of receiving placebo, and withdrew. Placebo surgery was undertaken successfully. Our study illustrated the opposing and often strongly held opinions about surgical placebos, the ethical issues underpinning this

Developing a placebo-controlled trial in surgery: Issues of design, acceptability and feasibility

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McDonald AM

2011-02-01

Full Text Available Abstract Background Surgical placebos are controversial. This in-depth study explored the design, acceptability, and feasibility issues relevant to designing a surgical placebo-controlled trial for the evaluation of the clinical and cost effectiveness of arthroscopic lavage for the management of people with osteoarthritis of the knee in the UK. Methods Two surgeon focus groups at a UK national meeting for orthopaedic surgeons and one regional surgeon focus group (41 surgeons; plenary discussion at a UK national meeting for orthopaedic anaesthetists (130 anaesthetists; three focus groups with anaesthetists (one national, two regional; 58 anaesthetists; two focus groups with members of the patient organisation Arthritis Care (7 participants; telephone interviews with people on consultant waiting lists from two UK regional centres (15 participants; interviews with Chairs of UK ethics committees (6 individuals; postal surveys of members of the British Association of Surgeons of the Knee (382 surgeons and members of the British Society of Orthopaedic Anaesthetists (398 anaesthetists; two centre pilot (49 patients assessed. Results There was widespread acceptance that evaluation of arthroscopic lavage had to be conducted with a placebo control if scientific rigour was not to be compromised. The choice of placebo surgical procedure (three small incisions proved easier than the method of anaesthesia (general anaesthesia. General anaesthesia, while an excellent mimic, was more intrusive and raised concerns among some stakeholders and caused extensive discussion with local decision-makers when seeking formal approval for the pilot. Patients were willing to participate in a pilot with a placebo arm; although some patients when allocated to surgery became apprehensive about the possibility of receiving placebo, and withdrew. Placebo surgery was undertaken successfully. Conclusions Our study illustrated the opposing and often strongly held opinions about

Is the perceived placebo effect comparable between adults and children? A meta-regression analysis.

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Janiaud, Perrine; Cornu, Catherine; Lajoinie, Audrey; Djemli, Amina; Cucherat, Michel; Kassai, Behrouz

2017-01-01

A potential larger perceived placebo effect in children compared with adults could influence the detection of the treatment effect and the extrapolation of the treatment benefit from adults to children. This study aims to explore this potential difference, using a meta-epidemiological approach. A systematic review of the literature was done to identify trials included in meta-analyses evaluating a drug intervention with separate data for adults and children. The standardized mean change and the proportion of responders (binary outcomes) were used to calculate the perceived placebo effect. A meta-regression analysis was conducted to test for the difference between adults and children of the perceived placebo effect. For binary outcomes, the perceived placebo effect was significantly more favorable in children compared with adults (β = 0.13; P = 0.001). Parallel group trials (β = -1.83; P < 0.001), subjective outcomes (β = -0.76; P < 0.001), and the disease type significantly influenced the perceived placebo effect. The perceived placebo effect is different between adults and children for binary outcomes. This difference seems to be influenced by the design, the disease, and outcomes. Calibration of new studies for children should consider cautiously the placebo effect in children.

Effects of ginger and expectations on symptoms of nausea in a balanced placebo design.

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Katja Weimer

Full Text Available OBJECTIVE: Ginger effects on (experimental nausea have been described, but also strong placebo effects and sex differences when nausea is involved. The "balanced placebo design" has been proposed to allow better separation of drug and placebo effects. METHODS: Sixty-four healthy participants (32 women were randomly assigned to receive an antiemetic ginger preparation or placebo, and half of each group was told to have received drug or placebo. They were exposed to 5×2 min body rotations to induce nausea. Subjective symptoms and behavioral (rotation tolerance, head movements and physiological measures (electrogastrogram, cortisol were recorded. Groups were balanced for sex of participants and experimenters. RESULTS: Ginger and the information given did not affect any outcome measure, and previous sex differences could not be confirmed. Adding the experimenters revealed a significant four-factorial interaction on behavioral but not on subjective or physiological measures Men who received placebo responded to placebo information when provided by the male experimenter, and to ginger information when provided by the female experimenter. This effect was not significant in women. CONCLUSION: The effects of an antiemetic drug and provided information interact with psychosocial variables of participants and experimenters in reports of nausea.

Design Dilemma: The Debate over Using Placebos in Cancer Clinical Trials

Science.gov (United States)

Many patients and researchers assert that in cancer clinical trials, placebos are inappropriate and that all participants should receive active treatment. But with the emergence of molecularly targeted anticancer agents, some cancer researchers believe placebo-controlled trials are now feasible and, in some cases, necessary.

Extracorporeal shockwave therapy versus placebo for the treatment of chronic proximal plantar fasciitis: results of a randomized, placebo-controlled, double-blinded, multicenter intervention trial.

Science.gov (United States)

Malay, D Scot; Pressman, Martin M; Assili, Amir; Kline, Jason T; York, Shane; Buren, Ben; Heyman, Eugene R; Borowsky, Pam; LeMay, Carley

2006-01-01

Extracorporeal shockwave therapy (ESWT) has demonstrated efficacy in the treatment of recalcitrant proximal plantar fasciitis. The objective of this investigation was to compare the outcomes of participants treated with a new ESWT device with those treated with placebo. A total of 172 volunteer participants were randomized in a 2:1 active-to-placebo ratio in this prospective, double-blind, multicenter trial conducted between October 2003 and December 2004. ESWT (n=115) or placebo control (n=57) was administered on a single occasion without local or systemic anesthesia or sedation, after which follow-up was undertaken. The primary outcomes were the blind assessor's objective, and the participant's subjective assessments of heel pain during the first 3 months of follow-up. Participants were also followed up to 1 year to identify any adverse outcomes that may have been related to the shockwave device. On the visual analog scale, the blind assessor's objective assessment of heel pain displayed a mean reduction of 2.51 in the shockwave group and 1.57 in the placebo group; this difference was statistically significant (P=.045). On the visual analog scale, the participant's self-assessment of heel pain displayed a mean reduction of 3.39 in the shockwave group and 1.78 in the placebo group; this difference was statistically significant (P<.001). No serious adverse events were observed at any time. It was concluded that ESWT was both efficacious and safe for participants with chronic proximal plantar fasciitis that had been unresponsive to exhaustive conservative treatment.

Placebo Sleep Affects Cognitive Functioning

Science.gov (United States)

Draganich, Christina; Erdal, Kristi

2014-01-01

The placebo effect is any outcome that is not attributed to a specific treatment but rather to an individual's mindset (Benson & Friedman, 1996). This phenomenon can extend beyond its typical use in pharmaceutical drugs to involve aspects of everyday life, such as the effect of sleep on cognitive functioning. In 2 studies examining whether…

Efecto del régimen de defoliación sobre la producción de grano en trigo doble propósito Effect of the defoliation regime on grain production in dual purpose wheat

OpenAIRE

N. Peralta; P.E. Abbate; A. Marino

2011-01-01

La utilización de cultivos de trigo con doble propósito contribuiría a realizar un uso más eficiente de los recursos ambientales. En Balcarce (Buenos Aires, Argentina) se estableció un cultivo de trigo (Triticum aestivum, cv. Baguette 20) sembrado en fecha temprana (17 de marzo de 2006) para comparar la producción de forraje obtenida con tres regímenes de defoliación: T1 (tres defoliaciones), T2 (dos defoliaciones) y TG (sin defoliaciones). En esos tres tratamientos y en otro no defoliado sem...

Placebo versus "standard" hypnosis rationale: attitudes, expectancies, hypnotic responses, and experiences.

Science.gov (United States)

Accardi, Michelle; Cleere, Colleen; Lynn, Steven Jay; Kirsch, Irving

2013-10-01

In this study participants were provided with either the standard rationale that accompanies the Harvard Group Scale of Hypnotic Susceptibility: A (Shor & Orne, 1962) or a rationale that presented hypnosis as a nondeceptive placebo, consistent with Kirsch's (1994) sociocognitive perspective of hypnosis. The effects of the placebo and standard rationales were highly comparable with respect to hypnotic attitudes; prehypnotic expectancies; objective, subjective, and involuntariness measures of hypnotic responding; as well as a variety of subjective experiences during hypnosis, as measured by the Phenomenology of Consciousness Inventory (Pekala, 1982). Differences among correlations were not evident when measures were compared across groups. However, indices of hypnotic responding were correlated with attitudes in the hypnosis but not the placebo condition, and, generally speaking, the link between subjective experiences during hypnosis and measures of hypnotic responding were more reliable in the placebo than the hypnosis group. Researcher findings are neutral with respect to providing support for altered state versus sociocognitive models of hypnosis.

Cognitive Schemas in Placebo and Nocebo Responding: Role of Autobiographical Memories and Expectations.

Science.gov (United States)

Bartels, Danielle J P; van Laarhoven, Antoinette I M; Heijmans, Naomi; Hermans, Dirk; Debeer, Elise; van de Kerkhof, Peter C M; Evers, Andrea W M

2017-03-01

Placebo effects are presumed to be based on one's expectations and previous experience with regard to a specific treatment. The purpose of this study was to investigate the role of the specificity and valence of memories and expectations with regard to itch in experimentally induced placebo and nocebo itch responses. It was expected that cognitive schemas with more general and more negative memories and expectations with regard to itch contribute to less placebo itch responding. Validated memory tasks (ie, the Autobiographical Memory Test and the Self-referential Endorsement and Recall Task) and expectation tasks (ie, Future Event Task and the Self-referential Endorsement and Recall Task) were modified for physical symptoms, including itch. Specificity and valence of memories and expectations were assessed prior to a placebo experiment in which expectations regarding electrical itch stimuli were induced in healthy participants. Participants who were more specific in their memories regarding itch and who had lesser negative itch-related expectations for the future were more likely to be placebo itch responders. There were no significant differences in effects between the nocebo responders and nonresponders. The adapted tasks for assessing cognitive (memory and expectations) schemas on itch seem promising in explaining interindividual differences in placebo itch responding. Future research should investigate whether similar mechanisms apply to patients with chronic itch. This knowledge can be used for identifying patients who will benefit most from the placebo component of a treatment. Copyright © 2017 The Authors. Published by Elsevier Inc. All rights reserved.

Double-blind, placebo-controlled food challenge with apple

DEFF Research Database (Denmark)

Skamstrup Hansen, K; Vestergaard, H; Stahl Skov, P

2001-01-01

The aim of the study was to develop and evaluate different methods of double-blind, placebo-controlled food challenge (DBPCFC) with apple. Three different DBPCFC models were evaluated: fresh apple juice, freshly grated apple, and freeze-dried apple powder. All challenges were performed outside...... frequency of reactions to placebo, probably due to the ingredients used for blinding. The sensitivity of the models with freshly grated apple and freeze-dried apple powder was 0.74/0.60. An increase in sensitivity is desirable. The freeze-dried apple powder proved to be useful for SPT, HR, and oral...

CARACTERIZACIÓN SOCIOECONÓMICA Y TECNOLÓGICA DE LOS AGROECOSISTEMAS CON BOVINOS DE DOBLE PROPÓSITO DE LA REGIÓN DEL PAPALOAPAN, VERACRUZ, MÉXICO

Directory of Open Access Journals (Sweden)

Julio Vilaboa-Arroniz

2008-12-01

Full Text Available El objetivo del presente trabajo fue caracterizar los componentes tecnológicos y socioeconómicos en los agroecosistemas con bovinos de doble propósito de la Región del Papaloapan, Veracruz, México. Se diseño y aplicó entrevistas semi-estructuradas a productores en las Asociaciones Ganaderas Locales y en ranchos ganaderos de los 21 municipios de la región objeto de estudio. Las variables incluidas fueron sociales, técnicas y de comercialización. El tamaño de muestra fue de 405 productores que representan el 4% del total de los ganaderos de la región. Se utilizó el análisis cluster, estadística descriptiva y tablas de contingencia. El análisis cluster, de acuerdo a las variables consideradas, permitió caracterizar a los productores en tres grupos: tradicional, de transición y empresarial. La edad para estos grupos de ganaderos fue 53±13, 54±15 y  56±12 años, y las cargas animal fueron 42.8±38.9, 154.1±88.3 y 123.8±93.5, respectivamente. En general, la finalidad zootécnica fue ganado doble propósito (86.9%, con pastoreo extensivo a libre pastoreo (98% como el sistema predominante y un patrón racial de la cruza Suizo x Cebú (79.8% como el más representativo.

A randomized, placebo-controlled trial of levetiracetam in central pain in multiple sclerosis

DEFF Research Database (Denmark)

Falah, M; Madsen, C; Holbech, J V

2012-01-01

sclerosis. This was a randomized, double-blind, placebo-controlled, cross-over trial with levetiracetam 3000 mg/day versus placebo (6-week treatment periods). Patients with multiple sclerosis, symptoms and signs complying with central neuropathic pain and pain symptoms for more than 6 months, as well....... Twenty-seven patients were included in the data analysis. There were no differences in the ratings of pain relief (levetiracetam 2.4 vs. placebo 2.1, p = 0.169), total pain intensity (levetiracetam 5.3 vs. placebo 5.7, p = 0.147) or any of the other outcome measures (p = 0.086-0.715) in the total sample...... of patients. However, there was significant reduction of pain, increased pain relief and/or more favourable pain relief with levetiracetam than with placebo in patients with lancinating or without touch-evoked pain (p = 0.025-0.046). This study found no effect of the anticonvulsant levetiracetam in non...

Caracterização da cultura de crack na cidade de São Paulo: padrão de uso controlado Caracterización de la cultura de crack en la ciudad de Sao Paulo: el padrón del uso controlado Characterization of the crack cocaine culture in the city of São Paulo: a controlled pattern of use

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Lúcio Garcia de Oliveira

2008-08-01

Full Text Available OBJETIVO: Caracterizar a situação do uso de crack na cidade de São Paulo, assim como o perfil sociodemográfico de seu usuário. PROCEDIMENTOS METODOLÓGICOS: Estudo qualitativo etnográfico com amostra intencional de usuários (n=45 e ex-usuários de crack (n=17. Os participantes foram recrutados pela técnica de amostragem em cadeias e responderam a uma entrevista semi-estruturada, direcionada por questionário, durante os anos de 2004 e 2005. O conjunto de cada questão e suas respectivas respostas originou relatórios específicos que foram interpretados individualmente. ANÁLISE DOS RESULTADOS: O perfil predominante do usuário de crack foi ser homem, jovem, solteiro, de baixa classe socioeconômica, baixo nível de escolaridade e sem vínculos empregatícios formais. O padrão de uso mais freqüentemente citado foi o compulsivo, caracterizado pelo uso múltiplo de drogas e desenvolvimento de atividades ilícitas em troca de crack ou dinheiro. Entretanto, identificou-se o uso controlado que consiste no uso não-diário de crack, mediado por fatores individuais, desenvolvidos intuitivamente pelo usuário e semelhantes, em natureza, às estratégias adotadas por ex-usuários para o alcance do estado de abstinência. CONCLUSÕES: A cultura do uso de crack tem sofrido mudanças quanto ao padrão de uso. Embora a maioria dos usuários o faça de forma compulsiva, observou-se a existência do uso controlado, que merece maior detalhamento, principalmente quanto às estratégias adotadas para seu alcance.OBJETIVO: Caracterizar la situación del uso de crack en la ciudad de Sao Paulo, así como el perfil sociodemográfico del usuario. PROCEDIMENTOS METODOLÓGICOS: Estudio cualitativo etnográfico con muestra intencional de usuarios (n=45 y ex-usuarios de crack (n=17. Los participantes fueron reclutados por la técnica de toma de muestra en cadenas y respondieron a una entrevista semi-estructurada, direccionada por cuestionario, durante los anos

Multinodular goiter treatment with radioiodine aided by recombinant human TSH in different doses: a randomized, double-blind, placebo-controlled study;Administracao previa do TSH humano recombinante, em diferentes doses, no tratamento do bocio multinodular com iodo radioativo: um estudo randomizado, duplo cego, controlado com placebo

Energy Technology Data Exchange (ETDEWEB)

Albino, Claudio Cordeiro

2009-07-01

Background: There is not an optimal treatment for multinodular goiter (MNG). Surgery is the main therapeutic option because it decreases thyroid volume, reduces compression symptoms and provide histological diagnosis. Radioiodine ({sup 131}I) is an efficient therapeutic option for the treatment of MNG mainly when surgery is not indicated or when the patient refused it. However, high activities of {sup 131}I are frequently required for clinically significant results. This procedure increases the body radiation exposure and the hospitalization costs. Recombinant human TSH (rh TSH) allows a reduction in the administered activity of {sup 131}I with effective thyroid volume (TV) reduction. However, this combination therapeutic can increase collateral effects. Objective: To evaluate the efficacy and safety of low and intermediate doses of rh TSH compared to placebo, associated with a fixed activity of {sup 131}I in MNG treatment. Patients and Methods: Thirty patients with MNG received 0.1 mg of rh TSH (group I, n=10), 0.01 mg of rh TSH (group II, n=10), or placebo (control group, n=10). After 24 hours, 30 mCi of {sup 131}I was given to all patients. Radioactive iodine uptake (RAIU) was determined before and 24 hours after rh TSH. Before and 2, 7, 180 and 360 days after the TV was measured by magnetic resonance image (MRI). The smallest cross-sectional area of tracheal lumen (Scat) was also measured with MRI before, 2 and 7 days after treatment. Antithyroid antibodies, TSH, T3 and free T4 were assessed regularly. Results: After 6 months, the decrease in TV was more significant in groups I (30.3 +- 16.5%) and II (22.6 +- 14.5%), than in control group (5.0 +- 14.6%; p=0.01). After 12 months, TV decreased more in group I (39.2 +- 16.9%) and group II (38.8 +- 24.4%) than in group III (23.4 +- 23.59%) but it was not statistically significant (p=0.205). During the first 30 days,total T3 and free T4 increased, without reaching thyrotoxic levels and TSH decreased. After 12 months

Systematic Review and Meta-analysis: Placebo Rates in Induction and Maintenance Trials of Ulcerative Colitis

NARCIS (Netherlands)

Jairath, Vipul; Zou, Guangyong; Parker, Claire E.; Macdonald, John K.; Mosli, Mahmoud H.; Khanna, Reena; Shackelton, Lisa M.; Vandervoort, Margaret K.; AlAmeel, Turki; Al Beshir, Mohammad; AlMadi, Majid; Al-Taweel, Talal; Atkinson, Nathan S. S.; Biswas, Sujata; Chapman, Thomas P.; Dulai, Parambir S.; Glaire, Mark A.; Hoekman, Daniel; Koutsoumpas, Andreas; Minas, Elizabeth; Samaan, Mark A.; Travis, Simon; D'Haens, Geert; Levesque, Barrett G.; Sandborn, William J.; Feagan, Brian G.

2016-01-01

Minimisation of the placebo responses in randomised controlled trials [RCTs] is essential for efficient evaluation of new interventions. Placebo rates have been high in ulcerative colitis [UC] clinical trials, and factors influencing this are poorly understood. We quantify placebo response and

Reducing placebo exposure in trials: Considerations from the Research Roundtable in Epilepsy.

Science.gov (United States)

Fureman, Brandy E; Friedman, Daniel; Baulac, Michel; Glauser, Tracy; Moreno, Jonathan; Dixon-Salazar, Tracy; Bagiella, Emilia; Connor, Jason; Ferry, Jim; Farrell, Kathleen; Fountain, Nathan B; French, Jacqueline A

2017-10-03

The randomized controlled trial is the unequivocal gold standard for demonstrating clinical efficacy and safety of investigational therapies. Recently there have been concerns raised about prolonged exposure to placebo and ineffective therapy during the course of an add-on regulatory trial for new antiepileptic drug approval (typically ∼6 months in duration), due to the potential risks of continued uncontrolled epilepsy for that period. The first meeting of the Research Roundtable in Epilepsy on May 19-20, 2016, focused on "Reducing placebo exposure in epilepsy clinical trials," with a goal of considering new designs for epilepsy regulatory trials that may be added to the overall development plan to make it, as a whole, safer for participants while still providing rigorous evidence of effect. This topic was motivated in part by data from a meta-analysis showing a 3- to 5-fold increased rate of sudden unexpected death in epilepsy in participants randomized to placebo or ineffective doses of new antiepileptic drugs. The meeting agenda included rationale and discussion of different trial designs, including active-control add-on trials, placebo add-on to background therapy with adjustment, time to event designs, adaptive designs, platform trials with pooled placebo control, a pharmacokinetic/pharmacodynamic approach to reducing placebo exposure, and shorter trials when drug tolerance has been ruled out. The merits and limitations of each design were discussed and are reviewed here. © 2017 American Academy of Neurology.

La escuela de ciegos del Campo de la Leña, A Coruña: los inicios de la enseñanza especial en Galicia

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Rodríguez Díaz, Ana

2014-12-01

Full Text Available The aim of this article is to show the relevance of the school for the blind opened in A Coruña by the Presbyterian José María Salgado, in 1895. This school was one of the few establishments in Spain that was dedicated, to the education these students, in the late 19th and early 20th century. It also constitutes a signficant contribution to the history of specialist education in Galicia. The Salgado School was the second institution for the blind of Galicia and the second in the city of A Coruña. This study approached Specialist Education from an historic, descriptive and comparative perspective, is based on concrete archived sources, along with the Galician press and other relevant current and historic publications. The literature review carried out to develop this work found very few monographic studies on these schools inaugurated at the end of the 19th century. There are large gaps in the information. Although they are often overlooked, some of these establishments represented a milestone in the beginnings of the institutionalisation of specialist education.Este artículo pretende mostrar la relevancia de la escuela de ciegos instaurada en la ciudad de A Coruña en el año 1895, por parte del presbítero José María Salgado. Esta escuela representa uno de los escasos establecimientos que, a finales del siglo XIX y principios del XX, se dedican en España a la educación de estos alumnos. Igualmente, constituye una contribución significativa en la historia de la enseñanza especial gallega. La escuela de Salgado figura como la segunda institución destinada a la instrucción de ciegos que se establece en Galicia y la primera que se establece en la ciudad de A Coruña. El presente estudio, abordado desde una perspectiva histórica, descriptiva y comparada, se ha fundamentado en fuentes archivísticas concretas, así como en la prensa histórica gallega y otras publicaciones históricas y actuales relativas a la educación especial. La

Avaliação da contaminação e poluição ambiental na área de influência do aterro controlado do Morro do Céu, Niterói, Brasil

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Cristina L. S. Sisinno

Full Text Available As áreas utilizadas como depósito final de lixo normalmente representadas pelos "lixões" e aterros controlados configuram-se como focos potenciais de poluição, influenciando negativamente a qualidade da saúde humana e ambiental nas regiões sob sua influência. Neste trabalho são avaliadas as concentrações de Cd, Cr, Cu, Fe, Mn, Ni, Pb e Zn no líquido percolado (chorume e em compartimentos ambientais (águas superficiais e subterrâneas, solos e sedimentos da área do aterro controlado do Morro do Céu (Niterói RJ. A qualidade dos corpos d'água localizados nas proximidades desse aterro foi também avaliada com base na análise de outros parâmetros físico-químicos e microbiológicos complementares (pH, DBO, DQO, colimetria etc.. Os resultados encontrados mostram que as maiores concentrações dos metais são observadas no solo do sítio limítrofe ao aterro e no sedimento da vala do aterro, indicando tendência à retenção destes elementos nesses segmentos. Da mesma forma, a qualidade das águas superficiais e subterrâneas é ruim, destacando-se a presença de coliformes nas amostras analisadas, além da evidência nas águas superficiais de grande carga de compostos orgânicos expressos pelos valores de DQO (5.200 mg/l e DBO (2.800 mg/l, e das concentrações de Fe (6,4 mg/l, Mn (2,4 mg/l, Ni (0,12 mg/l e Zn (0,23 mg/l acima dos limites permissíveis pela legislação ambiental.

Avaliação da contaminação e poluição ambiental na área de influência do aterro controlado do Morro do Céu, Niterói, Brasil

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Sisinno Cristina L. S.

1996-01-01

Full Text Available As áreas utilizadas como depósito final de lixo ­ normalmente representadas pelos "lixões" e aterros controlados ­ configuram-se como focos potenciais de poluição, influenciando negativamente a qualidade da saúde humana e ambiental nas regiões sob sua influência. Neste trabalho são avaliadas as concentrações de Cd, Cr, Cu, Fe, Mn, Ni, Pb e Zn no líquido percolado (chorume e em compartimentos ambientais (águas superficiais e subterrâneas, solos e sedimentos da área do aterro controlado do Morro do Céu (Niterói ­ RJ. A qualidade dos corpos d'água localizados nas proximidades desse aterro foi também avaliada com base na análise de outros parâmetros físico-químicos e microbiológicos complementares (pH, DBO, DQO, colimetria etc.. Os resultados encontrados mostram que as maiores concentrações dos metais são observadas no solo do sítio limítrofe ao aterro e no sedimento da vala do aterro, indicando tendência à retenção destes elementos nesses segmentos. Da mesma forma, a qualidade das águas superficiais e subterrâneas é ruim, destacando-se a presença de coliformes nas amostras analisadas, além da evidência ­ nas águas superficiais ­ de grande carga de compostos orgânicos expressos pelos valores de DQO (5.200 mg/l e DBO (2.800 mg/l, e das concentrações de Fe (6,4 mg/l, Mn (2,4 mg/l, Ni (0,12 mg/l e Zn (0,23 mg/l acima dos limites permissíveis pela legislação ambiental.

Escitalopram in the Treatment of Adolescent Depression: A Randomized, Double-Blind, Placebo-Controlled Extension Trial

Science.gov (United States)

Robb, Adelaide; Bose, Anjana

2013-01-01

Abstract Objective The purpose of this study was to evaluate the extended efficacy, safety, and tolerability of escitalopram relative to placebo in adolescents with major depressive disorder (MDD). Methods Adolescents (12–17 years) who completed an 8-week randomized, double-blind, flexible-dose, placebo-controlled, lead-in study of escitalopram 10–20 mg versus placebo could enroll in a 16–24-week, multisite extension trial; patients maintained the same lead-in randomization (escitalopram or placebo) and dosage (escitalopram 10 or 20 mg/day, or placebo) during the extension. The primary efficacy was Children's Depression Rating Scale-Revised (CDRS-R) change from the lead-in study baseline to treatment week 24 (8-week lead-in study plus 16-week extension); the secondary efficacy was Clinical Global Impressions-Improvement (CGI-I) score at week 24. All efficacy analyses used the last observation carried forward (LOCF) approach; sensitivity analyses used observed cases (OC) and mixed-effects model for repeated measures (MMRM). Safety was evaluated via adverse event (AE) reports and the clinician-rated Columbia-Suicide Severity Rating Scale (C-SSRS). Results Following lead-in, 165 patients enrolled in the double-blind extension (82 placebo; 83 escitalopram); 40 (48.8%) placebo and 37 (44.6%) escitalopram patients completed treatment. CDRS-R total score improvement was significantly greater for escitalopram than for placebo (p=0.005, LOCF; p=0.014; MMRM). Response rates (CDRS-R ≥40% reduction from baseline [adjusted and unadjusted] and CGI-I ≤2) were significantly higher for escitalopram than for placebo (LOCF); remission rates (CDRS-R ≤28) were 50.6% for escitalopram and 35.7% for placebo (p=0.002). OC analyses were not significantly different between groups. The most frequent escitalopram AEs (≥5% and more frequent than placebo) were headache, nausea, insomnia, vomiting, influenza-like symptoms, diarrhea, and urinary tract infection. Most AEs were

The use of placebo control in clinical trials: An overview of the ...

African Journals Online (AJOL)

The use of placebo control in clinical trials: An overview of the ethical issues involved for the protection of human research participants. ... A placebo looks exactly like the experimental drugs in every respect both in appearance and wrappings ...

Efecto de los micronutrientes en polvo en el estado nutricional y en los valores hemáticos de preescolares sanos, Medellín, 2013 / The effect of powdered micronutrients on the hematologic values and nutritional status of healthy preschoolers. Medellín, 2013

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Juliana Orozco C.

2015-09-01

Full Text Available RESUMEN Las carencias de micronutrientes son un problema de salud pública común en muchos países, principalmente en aquellos en vía de desarrollo; las deficiencias más prevalentes son las de vitamina A, hierro y yodo. Para reducirlas se pueden ejecutar estrategias como la fortificación de alimentos. Objetivo: evaluar el efecto de la fortificación de la dieta con micronutrientes en polvo en el estado nutricional y los valores hemáticos de preescolares sanos. Metodología: ensayo clínico triple ciego, con asignación aleatoria de grupos y controlado con placebo. Se analizaron 90 preescolares sanos a quienes se suministró 1g de mezcla de micronutrientes al día con 12,50 mg de hierro (fumarato ferroso. Antes y después de nueve semanas, se midieron los niveles de hemoglobina, ferritina sérica, transferrina, ácido fólico y los indicadores nutricionales. Resultados: la concentración de hemoglobina disminuyó en el grupo de intervención, pasando de 12,80 g/ dL a 12,10 g/dL (p = 0,000, mientras que en el grupo placebo no hubo variación (p = 0,639; así mismo la transferrina disminuyó significativamente solo en el grupo intervenido (p = 0,004; el nivel de ferritina al final del estudio no difirió intra o entre grupos de intervención. Las reacciones adversas fueron similares en ambos grupos: dos niños presentaron náusea y dos tuvieron dolor abdominal, sin diferencias estadísticas. Conclusiones: la fortificación de alimentos durante nueve semanas con los micronutrientes en polvo empleados en el estudio, no mejoró los niveles hematológicos, ni el estado nutricional de los niños sanos estudiados; los alimentos fortificados fueron bien tolerados por los preescolares./ ABSTRACT Micronutrient deficiencies are a common public health problem, particularly in developing countries. Vitamin A, iron and iodine deficiencies are the most prevalent. To reduce these, many strategies such as food fortification can be implemented. Objective: to

Olhando para trás: um novo caminho possível para a descoberta de drogas em psicofarmacologia Mirando hacia atrás: un nuevo camino posible para la descubierta de drogas en psicofarmacología Looking backwards: a possible new pathway for drug discovery in psychopharmacology

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Edward Shorter

2004-08-01

Full Text Available A história da psicofarmacologia é repleta de erros do tipo II - a rejeição de compostos efetivos baseada na crença enganosa de que eles foram ineficazes por não terem vencido o placebo em um ensaio clínico controlado. A revisão de algumas dessas drogas para estabelecer seu perfil de receptores e para determinar quais os compostos patenteáveis que atualmente estão na "prateleira" e que encaixam nesse perfil pode representar um caminho futuro possível para a descoberta de drogas. Este artigo examina as circunstâncias especiais nas quais inúmeras drogas potencialmente efetivas foram retiradas do mercado nos Estados Unidos.La historia de la psicofarmacología está llena de errores de tipo II - el rechazo de compuestos efectivos basado en la creencia equivocada de que ellos han sido ineficaces porque no han vencido el placebo en un ensayo clínico controlado. La revisión de algunas de esas drogas para establecer su perfil de receptores y para determinar cuales son los compuestos patentables que actualmente están en la "estante" y que se encajan en ese perfil puede representar un camino futuro posible para la descubierta de drogas. Este artículo analiza las circunstancias especiales en las que innumerables drogas potencialmente efectivas han sido retiradas del mercado en Estados Unidos.The history of psychopharmacology is littered with type II errors - the rejection of effective compounds in the specious belief that they were inefficacious because they had failed to beat placebo in a controlled trial. Revisiting some of these drugs to establish their receptor profile, and then determining what patentable compounds now on the shelf match that profile, might represent a possible future pathway to drug discovery. This article looks at the special circumstances in which numerous potentially effective drugs were withdrawn in the United States.

La Primera Muestra de Contabilidad por Partida Doble en la Catedral de Toledo. El Manual y Mayor del Racionero Gutierre Hurtado (1535-1536

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Susana Villaluenga de Gracia

2005-06-01

Full Text Available En la línea de las investigaciones desarrolladas sobre la contabilidad de las instituciones eclesiásticas en España, este trabajo estudia la que en el siglo XVI fue considerada la sede más rica de la Cristiandad después de Roma, la Catedral de Toledo. Su elevado estatus pudo ser una cuestión significativa para influir en el proceso de desarrollo de su sistema de gestión y en la adopción de prácticas contables novedosas. Además, dentro de la catedral existían beneficiados con aptitudes para dar solución a cualquier cuestión económica. Más concretamente, uno de ellos, el racionero Gutierre Hurtado, fue el autor de la primera muestra de contabilidad por partida doble en la catedral de Toledo y la primera muestra conocida, hoy por hoy, en el mundo para una entidad eclesiástica. En este trabajo se muestran algunos fragmentos sobre su vida y cometido; y los aspectos generales y especiales que caracterizan el método contable usado por este racionero. Para ello, examinaremos los documentos que se conservan en el Archivo de la Catedral de Toledo Palabras clave: Contabilidad eclesiástica, partida doble, catedral de Toledo.Through an approach close to the research of the studies on accounting of the religious organizations in Spain, this paper intends to study an entity that was considered the richest see of Christendom after Rome in the 16th century, the Cathedral of Toledo. Its highest level could possibly have been a significant element in the development of sophisticated management and accounting practices in this church. In addition, acting at the cathedral of Toledo, there were men who were capable to manage any economic question. More specifically, one of these prebendaries, Gutierre Hurtado, was the author of the first accounting demonstration for double entry in the cathedral of Toledo and the first one that is known, at the present time, in a religious organization on the world. This paper will show some features of all what we

Estimación de parámetros genéticos para características productivas y reproductivas en los sistemas doble propósito del trópico bajo colombiano

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A. P. Galeano

2010-01-01

Full Text Available Con el objetivo de estimar los componentes de varianza, las heredabilidades, repetibilidades y correlaciones genéticas y fenotípicas para la producción de leche por lactancia (PL, el peso al destete (PD, el intervalo entre partos (IEP y el Índice de Vaca (IV, de las hembras bovinas manejadas en los sistemas de producción de doble propósito del trópico bajo colombiano, se analizaron los registros productivos y reproductivos de 1.687 vacas registradas en la Asociación Colombiana de Criadores de Ganado en Doble Propósito (Asodoble, durante el periodo comprendido entre 1998 y 2007. Se empleó un modelo animal mixto que incluyó los efectos fijos del grupo contemporáneo (finca-sexo-época-año, la composición racial, y la duración de la lactancia como covariable; así como los efectos genéticos aleatorios del animal, el medio ambiente permanente y el residual. Las heredabilidades estimadas para IEP (0,04 y PD (0,11 fueron bajas, y moderadas para PL (0,35 e IV (0,24, respectivamente. La repetibilidad estimada para IEP fue baja (0,08, y para PL (0,41 e IV (0,31 moderada; en el caso de PD este valor fue igual a la heredabilidad (0,11. Las correlaciones genéticas y fenotípicas obtenidas entre PL y PD con respecto a IEP fueron positivas, y se determinó una asociación genética negativa entre PL y PD. Los resultados demostraron que el IV es un buen indicador, desde el punto de vista genético, de la eficiencia productiva y reproductiva de los animales manejados en estos sistemas productivos.

Estimación de parámetros genéticos para características productivas y reproductivas en los sistemas doble propósito del trópico bajo colombiano

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A. P. Galeano

2010-06-01

Full Text Available Con el objetivo de estimar los componentes de varianza, las heredabilidades, repetibilidadesy correlaciones genéticas y fenotípicas para la producción de leche por lactancia(PL, el peso al destete (PD, el intervalo entre partos (IEP y el Índice de Vaca (IV,de las hembras bovinas manejadas en los sistemas de producción de doble propósitodel trópico bajo colombiano, se analizaron los registros productivos y reproductivosde 1.687 vacas registradas en la Asociación Colombiana de Criadores de Ganado enDoble Propósito (Asodoble, durante el periodo comprendido entre 1998 y 2007. Seempleó un modelo animal mixto que incluyó los efectos fijos del grupo contemporáneo(finca-sexo-época-año, la composición racial, y la duración de la lactancia comocovariable; así como los efectos genéticos aleatorios del animal, el medio ambientepermanente y el residual. Las heredabilidades estimadas para IEP (0,04 y PD (0,11fueron bajas, y moderadas para PL (0,35 e IV (0,24, respectivamente. La repetibilidadestimada para IEP fue baja (0,08, y para PL (0,41 e IV (0,31 moderada; en el casode PD este valor fue igual a la heredabilidad (0,11. Las correlaciones genéticas y fenotípicasobtenidas entre PL y PD con respecto a IEP fueron positivas, y se determinóuna asociación genética negativa entre PL y PD. Los resultados demostraron que el IVes un buen indicador, desde el punto de vista genético, de la eficiencia productiva yreproductiva de los animales manejados en estos sistemas productivos.

El doble y el espejo en Cisne negro (Darren Aronofsky, 2010. The double and the mirror in Black Swan (Darren Aronofsky, 2010

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Ana España

2012-04-01

Full Text Available Con su último largometraje, Cisne negro (2010, Darren Aronofsky propone una nueva visión de su cine de la obsesión, a través del proceso de autodestrucción de una bailarina, sumergida en su afán por encarnar el papel principal en una obra de ballet.El presente artículo trata de abordar el tratamiento que el director realiza del fenómeno del doble, como vehículo sobre el que se sustenta la crisis obsesiva de la protagonista, atendiendo a sus diversas representaciones y objetivos en la configuración final del texto. With his latest film, Black Swan (2010, Darren Aronofsky offers a new vision of his obsession cinema, through the process of self-destruction of a dancer, immersed in her effort to embody the lead role in a ballet performance. This current article aim to attend the director treatment of the double phenomenon as a vehicle on which rests the obsessive crisis of the protagonist, according to their several representations and objectives in the final configuration of the text.

Active placebo control groups of pharmacological interventions were rarely used but merited serious consideration

DEFF Research Database (Denmark)

Jensen, Jakob Solgaard; Bielefeldt, Andreas Ørsted; Hróbjartsson, Asbjørn

2017-01-01

groups based on a random sample of 200 PubMed indexed placebo-controlled randomized drug trials published in October 2013. In a systematic review, we identified and characterized trials with active placebo control groups irrespective of publication time. In a third substudy, we reviewed publications...... with substantial methodological comments on active placebo groups (searches in PubMed, The Cochrane Library, Google Scholar, and HighWirePress). Results The prevalence of trials with active placebo groups published in 2013 was 1 out of 200 (95% confidence interval: 0–2), 0.5% (0–1%). We identified...

Impactos provocados por la sequía agrícola en el cultivo de Plátano (Musa en áreas del municipio Venezuela, Ciego de Ávila, Cuba

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Yurisbel Gallardo Ballat

2017-12-01

Full Text Available En la presente investigación se realiza el análisis del impacto provocado por la sequía agrícola en el cultivo del Plátano Vianda (Musa paradisiaca en un período de 13 años en áreas de municipio de Venezuela de la provincia de Ciego de Ávila. Cuba, para el análisis de los períodos de sequía se utilizó el Índice de Sequía Agraria (ISA el cual presenta dentro de su algoritmo matemático como variables determinantes la Evapotranspiración de Referencia, que en este caso se determinó con el método de Penman Monteith FAO-1998, el déficit de humedad, la precipitación efectiva y el rendimiento agrícola. Los resultados obtenidos demuestran que los procesos de sequías agrícolas se manifiestan en todos los ciclos del cultivo, afectando de manera general los rendimientos, la evaluación de fenómeno es de gran utilidad para el manejo sostenible de ecosistemas agrarios en aras de lograr mejores resultados productivos a mediano y corto plazo. El análisis de este fenómeno climatológico desde el punto de vista agrícola, permite trazar estrategias para la aplicación de métodos de conservación del suelo y del recurso hídrico a los agricultores.

Molecular and functional PET-fMRI measures of placebo analgesia in episodic migraine: Preliminary findings.

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Linnman, Clas; Catana, Ciprian; Petkov, Mike P; Chonde, Daniel Burje; Becerra, Lino; Hooker, Jacob; Borsook, David

2018-01-01

Pain interventions with no active ingredient, placebo, are sometimes effective in treating chronic pain conditions. Prior studies on the neurobiological underpinnings of placebo analgesia indicate endogenous opioid release and changes in brain responses and functional connectivity during pain anticipation and pain experience in healthy subjects. Here, we investigated placebo analgesia in healthy subjects and in interictal migraine patients (n = 9) and matched healthy controls (n = 9) using 11 C-diprenoprhine Positron Emission Tomography (PET) and simultaneous functional Magnetic Resonance Imaging (fMRI). Intravenous saline injections (the placebo) led to lower pain ratings, but we did not find evidence for an altered placebo response in interictal migraine subjects as compared to healthy subjects.

Molecular and functional PET-fMRI measures of placebo analgesia in episodic migraine: Preliminary findings

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Clas Linnman

2018-01-01

Full Text Available Pain interventions with no active ingredient, placebo, are sometimes effective in treating chronic pain conditions. Prior studies on the neurobiological underpinnings of placebo analgesia indicate endogenous opioid release and changes in brain responses and functional connectivity during pain anticipation and pain experience in healthy subjects. Here, we investigated placebo analgesia in healthy subjects and in interictal migraine patients (n = 9 and matched healthy controls (n = 9 using 11C-diprenoprhine Positron Emission Tomography (PET and simultaneous functional Magnetic Resonance Imaging (fMRI. Intravenous saline injections (the placebo led to lower pain ratings, but we did not find evidence for an altered placebo response in interictal migraine subjects as compared to healthy subjects.

Tratamiento del síncope neuralmente mediado con marcapasos: utilidad del sensor de asa cerrada

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Martín de la Ossa

2015-01-01

Full Text Available El síncope vasovagal es una entidad frecuente, de difícil manejo, con alta tasa de recurrencia aun con manejo médico. Se ha estudiado la estimulación cardiaca en pacientes con respuesta cardioinhibitoria en la mesa basculante con resultados contradictorios. Los estudios iniciales mostraron buenos resultados, que no lograron reproducirse cuando se introdujo el diseño doble ciego. La mayoría de estos estudios se realizaron con marcapasos con sensores convencionales. Las guías actuales de dispositivos indican la terapia de estimulación cardiaca en síncope vasovagal con respuesta cardioinhibitoria como una alternativa ante la no respuesta al tratamiento convencional. Existe evidencia reciente que indica que los marcapasos con sensores de asa cerrada (CLS, del inglés closed-loop sensor muestran mejores resultados que los sensores convencionales; estos estudios, aunque con población pequeña, reportan reducciones de la frecuencia de síncopes y presíncopes. Este tipo de dispositivos actúan en etapas más tempranas de la cascada de eventos fisiopatológicos del síncope vasovagal, detectando cambios en la impedancia ventricular antes de la caída de la frecuencia cardiaca, lo cual permite intervenir en forma precoz con estimulación para evitar el síncope.

EVALUACIÓN DE LAS TÉCNICAS DE CEPILLADO DE BASS Y VERTICAL EN UN GRUPO DE PACIENTES EN TRATAMIENTO DE ORTODONCIA CON TÉCNICA MBT

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Yelitza Ivone Baracaldo Ortíz

2012-07-01

Full Text Available Objetivo: Evaluar la efectividad de las técnicas de Cepillado de Bass y Vertical en pacientes con aparatología ortodóntica fija tratados con la técnica MBT. Materiales y métodos: se realizó un estudio experimental “In vivo” aleatorizado doble ciego; la muestra fue de 100 personas distribuidas en dos grupos, a cada uno se le asignó una Técnica de Cepillado y se dieron instrucciones de higiene oral por medio de charlas personalizadas y por escrito. Se usó el índice de Sillnes y Löe para medir el porcentaje de placa bacteriana, el cual fue realizado por una higienista oral, cada 30 ± 3 días durante 3 meses. A los dos grupos se les realizó profilaxis con el objetivo de tener un índice inicial de placa lo más aproximado a cero. A los participantes se les entregó mensualmente los aditamentos de higiene oral que debían usar. Resultados: antes de dar instrucciones de higiene oral el 73,4% tenían índice de placa moderado, el 16,46% severo y el 10,3% incipiente. El grupo de Técnica Vertical obtuvo mayor reducción de placa en comparación con el grupo de Técnica  Bass durante la primera toma (p

Evaluation of flurazepam and placebo on sleep disorders in childhood

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Reimão, Rubens; Lefévre, Antonio B.

1982-01-01

The clinically observed results in 40 patients, from 1 to 15 years old, presenting sleep disturbances, in a comparative and statistically approached study of flurazepam 15mg daily against placebo, are reported. Placebo was administered, followed by the drug, during 14 days each. The chief complaints were sleepwalking, sleep-talking, sleep terror, sleep-related bruxism, sleep-related headbanging, insomnia and excessive movements during sleep. A significant effect of flurazepam on sleepwalking,...

A double-blind comparison of fluvoxamine versus placebo in the treatment of compulsive buying disorder.

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Black, D W; Gabel, J; Hansen, J; Schlosser, S

2000-12-01

Nondepressed outpatients with a compulsive buying disorder were recruited by advertisement and word of mouth for inclusion in a controlled treatment trial. Following a 1-week single-blind placebo washout, subjects were randomly assigned to fluvoxamine (n = 12) or placebo (n = 11). Subjects received fluvoxamine (up to 300 mg daily) or placebo for 9 weeks. There were few dropouts. Outcome measures included the Yale-Brown Obsessive-Compulsive Scale--Shopping Version (YBOCS-SV), three Clinical Global Impressions (CGI) ratings, the Hamilton Rating Scale for Depression (HRSD), and the Maudsley Obsessive-compulsive Inventory (MOI). At the conclusion of the trial, 50% of fluvoxamine recipients and 63.6% of placebo recipients achieved CGI ratings of "much" or "very much" improvement, while 33% of fluvoxamine recipients were "very much" improved compared with 18% of placebo recipients (by endpoint analysis). Subjects in both treatment cells showed improvement as early as the second week of the trial, and for most, improvement continued during the 9-week study. There were no significant differences between fluvoxamine- and placebo-treated subjects on any of the outcome measures, with the exception that fluvoxamine recipients achieved greater improvement than placebo recipients on the MOI (p = .02). Adverse experiences were more frequent in the group receiving fluvoxamine, particularly nausea, insomnia, decreased motivation, and sedation. We conclude that in a short-term treatment trial of compulsive buying, subjects receiving fluvoxamine or placebo respond similarly.

Cognitive outcomes of preterm infants randomized to darbepoetin, erythropoietin, or placebo.

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Ohls, Robin K; Kamath-Rayne, Beena D; Christensen, Robert D; Wiedmeier, Susan E; Rosenberg, Adam; Fuller, Janell; Lacy, Conra Backstrom; Roohi, Mahshid; Lambert, Diane K; Burnett, Jill J; Pruckler, Barbara; Peceny, Hannah; Cannon, Daniel C; Lowe, Jean R

2014-06-01

We previously reported decreased transfusions and donor exposures in preterm infants randomized to Darbepoetin (Darbe) or erythropoietin (Epo) compared with placebo. As these erythropoiesis-stimulating agents (ESAs) have shown promise as neuroprotective agents, we hypothesized improved neurodevelopmental outcomes at 18 to 22 months among infants randomized to receive ESAs. We performed a randomized, masked, multicenter study comparing Darbe (10 μg/kg, 1×/week subcutaneously), Epo (400 U/kg, 3×/week subcutaneously), and placebo (sham dosing 3×/week) given through 35 weeks' postconceptual age, with transfusions administered according to a standardized protocol. Surviving infants were evaluated at 18 to 22 months' corrected age using the Bayley Scales of Infant Development III. The primary outcome was composite cognitive score. Assessments of object permanence, anthropometrics, cerebral palsy, vision, and hearing were performed. Of the original 102 infants (946 ± 196 g, 27.7 ± 1.8 weeks' gestation), 80 (29 Epo, 27 Darbe, 24 placebo) returned for follow-up. The 3 groups were comparable for age at testing, birth weight, and gestational age. After adjustment for gender, analysis of covariance revealed significantly higher cognitive scores among Darbe (96.2 ± 7.3; mean ± SD) and Epo recipients (97.9 ± 14.3) compared with placebo recipients (88.7 ± 13.5; P = .01 vs ESA recipients) as was object permanence (P = .05). No ESA recipients had cerebral palsy, compared with 5 in the placebo group (P < .001). No differences among groups were found in visual or hearing impairment. Infants randomized to receive ESAs had better cognitive outcomes, compared with placebo recipients, at 18 to 22 months. Darbe and Epo may prove beneficial in improving long-term cognitive outcomes of preterm infants. Copyright © 2014 by the American Academy of Pediatrics.

Oral lysine clonixinate in the acute treatment of migraine: a double-blind placebo-controlled study.

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Krymchantowski, A V; Barbosa, J S; Cheim, C; Alves, L A

2001-03-01

Several oral nonsteroidal anti-inflammatory drugs (NSAIDs) are effective to treat migraine attacks. Lysine clonixinate (LC) is a NSAID derived from nicotinic acid that has proven to be effective in various pain syndromes such as renal colic and muscular pain. The aim of this double-blind, placebo-controlled study was to evaluate the efficacy of oral LC compared to placebo in the acute treatment of migraine. Sixty four patients with the diagnosis of migraine, according to the IHS criteria, were studied prospectively. Patients received LC or placebo once the headache reached moderate or severe intensity for 6 consecutive attacks. With regard to the moderate attacks, LC was superior than placebo after 1, 2 and 4 hours. The consumption of other rescue medications after 4 hours was significantly higher in the placebo group. With regard to the severe attacks, there was no difference between the active drug group and the placebo group concerning headache intensity and consumption of other rescue medications. We conclude that the NSAID lysine clonixinate is effective in treating moderately severe migraine attacks. It is not superior than placebo in treating severe migraine attacks.

Factor de crecimiento semejante a la insulina tipo I (IGF-I y cirrosis hepática Insulin-like growth factor I (IGF-I and liver cirrhosis

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M. Conchillo

2007-03-01

Full Text Available El factor de crecimiento semejante a la insulina tipo I (IGF-I es una hormona polipeptídica segregada en múltiples tejidos por efecto de la hormona de crecimiento (GH. Es responsable de parte de las acciones de la GH y además tiene efecto hipoglucemiante y anabolizante. El 90% del IGF-I circulante es de origen hepático y ejerce efectos autocrinos, paracrinos y endocrinos, estos últimos en múltiples tejidos. En la cirrosis hepática se produce una disminución progresiva de la producción hepática de IGF-I que llega a ser indetectable en la enfermedad avanzada. Algunas de las complicaciones de la cirrosis, fundamentalmente nutricionales y metabólicas (resistencia a insulina, desnutrición, osteopenia, hipogonadismo, alteraciones intestinales podrían estar, al menos en parte, relacionadas con esta carencia de IGF-I dado que algunas acciones de IGF-I representan la imagen inversa de las complicaciones de la cirrosis. A pesar de ello, nunca se había propuesto tratamiento sustitutivo con IGF-I en la cirrosis. En una serie de estudios experimentales realizados en ratas cirróticas se demostró que el tratamiento con dosis bajas de IGF-I recombinante produce dos tipos de efectos en la cirrosis experimental: a mejoría del hígado, dado que mejora la función hepatocelular, la hipertensión portal y la fibrosis hepática; y b mejoría de las alteraciones extrahepáticas de la cirrosis dado que mejora la eficiencia del alimento ingerido, la masa muscular, la masa ósea, la función y estructura gonadales y la función y estructura intestinales con normalización de la malabsorción de azúcares y aminoácidos y la mejoría de la función intestinal de barrera manifestada por disminución de la endotoxemia y la translocación bacteriana. Posteriormente el primer ensayo clínico piloto, aleatorizado, doble ciego y controlado con placebo llevado a cabo en un número reducido de pacientes cirróticos demostró aumento de la albúmina sérica y

Intravenous lidocaine for postmastectomy pain treatment: randomized, blind, placebo controlled clinical trial

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Tania Cursino de Menezes Couceiro

2015-06-01

Full Text Available BACKGROUND AND OBJECTIVE: Postoperative pain treatment in mastectomy remains a major challenge despite the multimodal approach. The aim of this study was to investigate the analgesic effect of intravenous lidocaine in patients undergoing mastectomy, as well as the postoperative consumption of opioids. METHODS: After approval by the Human Research Ethics Committee of the Instituto de Medicina Integral Prof. Fernando Figueira in Recife, Pernambuco, a randomized, blind, controlled trial was conducted with intravenous lidocaine at a dose of 3 mg/kg infused over 1 h in 45 women undergoing mastectomy under general anesthesia. One patient from placebo group was. RESULTS: Groups were similar in age, body mass index, type of surgery, and postoperative need for opioids. Two of 22 patients in lidocaine group and three of 22 patients in placebo group requested opioid (p = 0.50. Pain on awakening was identified in 4/22 of lidocaine group and 5/22 of placebo group (p = 0.50; in the post-anesthetic recovery room in 14/22 and 12/22 (p = 0.37 of lidocaine and placebo groups, respectively. Pain evaluation 24 h after surgery showed that 2/22 and 3/22 patients (p = 0.50 of lidocaine and placebo groups, respectively, complained of pain. CONCLUSION: Intravenous lidocaine at a dose of 3 mg/kg administered over a period of an hour during mastectomy did not promote additional analgesia compared to placebo in the first 24 h, and has not decreased opioid consumption. However, a beneficial effect of intravenous lidocaine in selected and/or other therapeutic regimens patients cannot be ruled out.

Seeing is believing: Impact of social modeling on placebo and nocebo responding.

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Faasse, Kate; Grey, Andrew; Jordan, Rachel; Garland, Stacie; Petrie, Keith J

2015-08-01

This study investigated the impact of the social modeling of side effects following placebo medication ingestion on the nocebo and placebo effect. It also investigated whether medication branding (brand or generic labeling) moderated social modeling effects. Eighty-two university students took part in the study which was purportedly investigating the impact of fast-acting beta-blocker medications (actually placebos) on preexamination anxiety. After taking the medication, participants were randomized to either witness a female confederate report experiencing side effects or no side effects after taking the same medication. Differences in symptom reporting, blood pressure, heart rate, and anxiety were assessed between the social modeling of side effects and no modeling groups. Seeing a female confederate report side effects reduced the placebo effect in systolic (p = .009) and diastolic blood pressure (p = .033). Seeing a female confederate report side effects also increased both total reported symptoms (mean [SE] 7.35 [.54] vs. 5.16 [0.53] p = .005) and symptoms attributed to the medication (5.27 [0.60] vs. 3.04 [0.59] p = .01), although the effect on symptoms was only seen in female participants. Females who saw the confederate report side effects reported approximately twice the number of symptoms as those in the no modeling group. Social modeling did not affect heart rate or anxiety. Medication branding did not influence placebo or nocebo outcomes. The social modeling of symptoms can substantially reduce or eliminate the placebo effect. Viewing a female confederate display symptoms after taking the same medication increases symptom reporting in females. (c) 2015 APA, all rights reserved).

Measurement of event-related potentials and placebo

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Sovilj Platon

2014-01-01

Full Text Available ERP is common abbreviation for event-related brain potentials, which are measured and used in clinical practice as well as in research practice. Contemporary studies of placebo effect are often based on functional neuromagnetic resonance (fMRI, positron emission tomography (PET, and event related potentials (ERP. This paper considers an ERP instrumentation system used in experimental researches of placebo effect. This instrumentation system can be divided into four modules: electrodes and cables, conditioning module, digital measurement module, and PC module for stimulations, presentations, acquisition and data processing. The experimental oddball paradigm is supported by the software of the instrumentation. [Projekat Ministarstva nauke Republike Srbije, br. TR32019 and Provincial Secretariat for Science and Technological Development of Autonomous Province of Vojvodina (Republic of Serbia under research grant No. 114-451-2723

Evaluation of Isosorbide Mononitrate for Preinduction of Cervical Ripening: A Randomized Placebo-Controlled Trial.

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Ramya Krishnamurthy

2015-06-01

Full Text Available To evaluate the safety and efficacy of Isosorbide mononitrate (IMN as a cervical ripening agent prior to induction of labour in term pregnant women.A randomized placebo-controlled study was conducted on 100 term singleton pregnancies planned for induction of labour. The participants were randomly assigned to two groups. One group received 40 mg IMN and the other group received 40mg of placebo kept vaginally. The main outcome of this study was to evaluate the efficacy of IMN in cervical ripening based on the change in modified Bishop score and the effect on time duration between the drug insertion and delivery. Safety of isosorbide mononitrate was assessed by measuring variables related to maternal and neonatal outcomes.Baseline demographic characteristics were similar in both groups. The mean change in modified Bishop score after 2 doses of 40mg IMN was insignificant when compared to placebo. Though IMN shortened the time duration between the drug insertion to delivery when compared to placebo, it was statistically insignificant. The need for oxytocin and 2(nd ripening agent was less in IMN group when compared to placebo group but statistically this also proved to be insignificant. It was noted that there was an increase in caesarean deliveries in IMN than in placebo group. IMN did not cause any significant change in maternal hemodynamics and adverse side effects. Though NICU admission and stay was less in IMN than in placebo group, it was statistically insignificant.Though IMN did not cause any maternal and neonatal adverse effects, it was found to be inefficient in comparison to placebo as a cervical ripening agent.

Validation and acceptability of double-blind, placebo-controlled food challenges in children

NARCIS (Netherlands)

Venter, Carina; Maslin, Kate; Patil, Veeresh; Grundy, Jane; Glasbey, Gillian; Raza, Abid; Vlieg-Boerstra, Berber; Dean, Taraneh

2016-01-01

The Double Blind Placebo Controlled Food Challenge (DBPCFC) is considered the gold standard for food allergy diagnosis (1, 2). It is recommended that active and placebo challenge foods for DBPCFCs are sufficiently blinded in terms of smell, flavour and texture. Difficulties arise with children

Rectal microbicides: clinically relevant approach to the design of rectal specific placebo formulations

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Dezzutti Charlene

2011-03-01

Full Text Available Abstract Background The objective of this study is to identify the critical formulation parameters controlling distribution and function for the rectal administration of microbicides in humans. Four placebo formulations were designed with a wide range of hydrophilic characteristics (aqueous to lipid and rheological properties (Newtonian, shear thinning, thermal sensitive and thixotropic. Aqueous formulations using typical polymers to control viscosity were iso-osmotic and buffered to pH 7. Lipid formulations were developed from lipid solvent/lipid gelling agent binary mixtures. Testing included pharmaceutical function and stability as well as in vitro and in vivo toxicity. Results The aqueous fluid placebo, based on poloxamer, was fluid at room temperature, thickened and became shear thinning at 37°C. The aqueous gel placebo used carbopol as the gelling agent, was shear thinning at room temperature and showed a typical decrease in viscosity with an increase in temperature. The lipid fluid placebo, myristyl myristate in isopropyl myristate, was relatively thin and temperature independent. The lipid gel placebo, glyceryl stearate and PEG-75 stearate in caprylic/capric triglycerides, was also shear thinning at both room temperature and 37°C but with significant time dependency or thixotropy. All formulations showed no rectal irritation in rabbits and were non-toxic using an ex vivo rectal explant model. Conclusions Four placebo formulations ranging from fluid to gel in aqueous and lipid formats with a range of rheological properties were developed, tested, scaled-up, manufactured under cGMP conditions and enrolled in a formal stability program. Clinical testing of these formulations as placebos will serve as the basis for further microbicide formulation development with drug-containing products.

Placebo Response is Driven by UCS Revaluation: Evidence, Neurophysiological Consequences and a Quantitative Model

OpenAIRE

Luca Puviani; Sidita Rama

2016-01-01

Despite growing scientific interest in the placebo effect and increasing understanding of neurobiological mechanisms, theoretical modeling of the placebo response remains poorly developed. The most extensively accepted theories are expectation and conditioning, involving both conscious and unconscious information processing. However, it is not completely understood how these mechanisms can shape the placebo response. We focus here on neural processes which can account for key properties of th...

Randomized clinical trial comparing oral prednisone (50 mg) with placebo before laparoscopic cholecystectomy

DEFF Research Database (Denmark)

Bisgaard, Thue; Schulze, S.; Hjortso, N.C.

2008-01-01

cholecystectomy. Methods In a double-blind placebo-controlled study, 200 patients were randomized to oral administration of prednisone (50 mg) or placebo 2 h before laparoscopic cholecystectomy. Patients received a similar standardized anaesthetic, surgical, and analgesic treatment. The primary outcome was pain......-h pain, fatigue or malaise scores or any other variables were found (P > 0.05). Conclusion There is no important clinical gain of preoperative oral steroid administration compared with placebo in patients undergoing laparoscopic cholecystectomy Udgivelsesdato: 2008/2...

Identificación paramétrica en lazo cerrado de sistema de accionamiento neumático para cilindro de doble efecto

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Oscar Caldas Flautero

2013-01-01

Full Text Available Los modelos matemáticos que permiten comprender un sistema y predecir o simular su comportamiento suelen presentar inconvenientes cuando se cuenta con poca información a priori o se desconocen los parámetros físicos. Por esa razón, en este trabajo se presenta la identificación de sistemas como estrategia para abordar la construcción de modelos dinámicos complejos, proponiendo soluciones para tratar el comportamiento no-lineal de un sistema neumático, representado por un actuador de doble efecto y un par de válvulas proporcionales para el control de la presión de alimentación y el caudal. Se presenta una aproximación almodelomatemático para determinar el orden del sistema, la identificación en lazo abierto y lazo cerrado y la comparación entre modelos de procesosARX yARMAX, con diferente orden, para concluir con simulaciones comparativas entre la respuesta del sistema real y la del identificado.

Analizando la Efectividad del Uso de un EVCI para Asistir a Estudiantes Avanzados en la Identificación de Faltas en el Código: Un Experimento Controlado

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Juan P. Ucán-Pech

2016-04-01

Full Text Available El objetivo de esta investigación se centra en el estudio de la detección de faltas con y sin apoyo de un Entorno Virtual Colaborativo Inteligente (EVCI, a través de una replicación independiente de un experimento controlado. A diferencia de otros estudios realizados con el apoyo de un EVCI, este trabajo se desarrolló empleando como sujetos experimentales a estudiantes avanzados de pregrado. En este trabajo se explora la efectividad en la detección de faltas en programas instrumentados en Java con y sin apoyo de un EVCI. Con respecto a las faltas observadas por los sujetos, se obtuvo una efectividad equivalente para quienes emplearon el EVCI (53.70% como para quienes trabajaron de manera tradicional (50.00%. Se observa que en esta segunda réplica, los sujetos lograron identificar un número mayor de faltas con respecto a la primera réplica de este experimento.

Active placebo control groups of pharmacological interventions were rarely used but merited serious consideration: a methodological overview.

Science.gov (United States)

Jensen, Jakob Solgaard; Bielefeldt, Andreas Ørsted; Hróbjartsson, Asbjørn

2017-07-01

Active placebos are control interventions that mimic the side effects of the experimental interventions in randomized trials and are sometimes used to reduce the risk of unblinding. We wanted to assess how often randomized clinical drug trials use active placebo control groups; to provide a catalog, and a characterization, of such trials; and to analyze methodological arguments for and against the use of active placebo. An overview consisting of three thematically linked substudies. In an observational substudy, we assessed the prevalence of active placebo groups based on a random sample of 200 PubMed indexed placebo-controlled randomized drug trials published in October 2013. In a systematic review, we identified and characterized trials with active placebo control groups irrespective of publication time. In a third substudy, we reviewed publications with substantial methodological comments on active placebo groups (searches in PubMed, The Cochrane Library, Google Scholar, and HighWirePress). The prevalence of trials with active placebo groups published in 2013 was 1 out of 200 (95% confidence interval: 0-2), 0.5% (0-1%). We identified and characterized 89 randomized trials (published 1961-2014) using active placebos, for example, antihistamines, anticholinergic drugs, and sedatives. Such trials typically involved a crossover design, the experimental intervention had noticeable side effects, and the outcomes were patient-reported. The use of active placebos was clustered in specific research settings and did not appear to reflect consistently the side effect profile of the experimental intervention, for example, selective serotonin reuptake inhibitors were compared with active placebos in pain trials but not in depression trials. We identified and analyzed 25 methods publications with substantial comments. The main argument for active placebo was to reduce risk of unblinding; the main argument against was the risk of unintended therapeutic effect. Pharmacological

Intervenciones Placebo Para Incrementar el Rendimiento Deportivo: un Tema Revisitado

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MILDRETH LARQUIN-CASTILLO

2015-01-01

Full Text Available Las intervenciones psicológicas para incrementar el rendimiento de los deportistas han ganado gran popularidad. En este artículo se realizó una revisión de la utilización de intervenciones placebo para potenciar el rendimiento deportivo, a partir de la cual se concluyó que el contexto de aplicación, los rasgos de personalidad del deportista y el ritual de intervención han sido propuestos como los factores más relevantes a tomar en consideración. Se estima que, a pesar de las limitaciones, las intervenciones placebo constituyen alternativas eficaces que tienen distintos modos de aplicación. La utilización de vías conscientes y no-conscientes para activar el efecto placebo se materializa en el empleo de las potencialidades que brindan tanto la sugestión verbal como el priming.

Placebo effect in clinical trial design for irritable bowel syndrome.

Science.gov (United States)

Shah, Eric; Pimentel, Mark

2014-04-30

Ongoing efforts to improve clinical trial design in irritable bowel syndrome have been hindered by high placebo response rates and ineffective outcome measures. We assessed established strategies to minimize placebo effect as well as the various ap-proaches to placebo effect which can affect trial design. These include genetic markers such as catechol-O-methyltransferase, opioidergic and dopaminergic neurobiologic theory, pre-cebo effect centered on expectancy theory, and side effect unblinding grounded on conditioning theory. We reviewed endpoints used in the study of IBS over the past decade including adequate relief and subjective global relief, emphasizing their weaknesses in fully evaluating the IBS condition, specifically their motility effects based on functional net value and relative benefit-harm based on dropouts due to adverse events. The focus of this review is to highlight ongoing efforts to improve clinical trial design which can lead to better outcomes in a real-world setting.

New validated recipes for double-blind placebo-controlled low-dose food challenges.

Science.gov (United States)

Winberg, Anna; Nordström, Lisbeth; Strinnholm, Åsa; Nylander, Annica; Jonsäll, Anette; Rönmark, Eva; West, Christina E

2013-05-01

Double-blind placebo-controlled food challenges are considered the most reliable method to diagnose or rule out food allergy. Despite this, there are few validated challenge recipes available. The present study aimed to validate new recipes for low-dose double-blind placebo-controlled food challenges in school children, by investigating whether there were any sensory differences between the active materials containing cow's milk, hen's egg, soy, wheat or cod, and the placebo materials. The challenge materials contained the same hypoallergenic amino acid-based product, with or without added food allergens. The test panels consisted of 275 school children, aged 8-10 and 14-15 yr, respectively, from five Swedish schools. Each participant tested at least one recipe. Standardized blinded triangle tests were performed to investigate whether any sensory differences could be detected between the active and placebo materials. In our final recipes, no significant differences could be detected between the active and placebo materials for any challenge food (p > 0.05). These results remained after stratification for age and gender. The taste of challenge materials was acceptable, and no unfavourable side effects related to test materials were observed. In summary, these new validated recipes for low-dose double-blinded food challenges contain common allergenic foods in childhood; cow's milk, hen's egg, soy, wheat and cod. All test materials contain the same liquid vehicle, which facilitates preparation and dosing. Our validated recipes increase the range of available recipes, and as they are easily prepared and dosed, they may facilitate the use of double-blind placebo-controlled food challenges in daily clinical practice. © 2013 John Wiley & Sons A/S. Published by Blackwell Publishing Ltd.

Vortioxetine versus placebo in major depressive disorder comorbid with social anxiety disorder.

Science.gov (United States)

Liebowitz, Michael R; Careri, Jason; Blatt, Kyra; Draine, Ann; Morita, Junko; Moran, Melissa; Hanover, Rita

2017-12-01

Major Depressive Disorder (MDD) and Social Anxiety Disorder (SAD) are highly comorbid, yet the combined condition has not been subject to any placebo-controlled treatment trials. This study reports a trial of vortioxetine, an antidepressant that has also shown benefit in Generalized Anxiety Disorder (GAD), in patients meeting DSM-5 criteria for both MDD and SAD. The study was a 12-week double-blind, placebo-controlled comparison of vortioxetine 10-20 mg/day or placebo administered on a 1:1 ratio. The study was designed to include 40 male or female outpatients aged 18-70 years. The primary endpoint was the "composite" Clinical Global Impression of Improvement (CGI-I) responder rate, factoring in improvement in both MDD and SAD features. Major secondary outcome measures were changes on the Montgomery Asberg Depression Rating Scale (MADRS) and Liebowitz Social Anxiety Scale (LSAS). On the composite CGI-I, 10 of 20 (50%) vortioxetine and six of 20 (30%) placebo-treated patients were rated as responders, a non-significant difference. However, vortioxetine-treated patients did show significantly greater improvement than those on placebo on both the MADRS (effect size 0.672) and LSAS (effect size 0.714). Efficacy in depression was seen before improvement in SAD. Adverse effects were similar to those previously reported. In this preliminary trial vortioxetine appears safe and effective for patients with MDD comorbid with SAD, with robust effect sizes on dimensional measures of both depression and social anxiety, but failure to separate from placebo on the primary outcome measure of composite responder rate. More studies of patients with comorbid conditions are needed, as this mirrors what is often seen in clinical practice. © 2017 Wiley Periodicals, Inc.

Immunomodulatory effects of ResistAid™: A randomized, double-blind, placebo-controlled, multidose study.

Science.gov (United States)

Udani, Jay K

2013-01-01

To evaluate the ability of a proprietary arabinogalactan extract from the larch tree (ResistAid, Lonza Ltd., Basel, Switzerland) to change the immune response in healthy adults to a standardized antigenic challenge (tetanus and influenza vaccines) in a dose-dependent manner compared to placebo. This randomized, double-blind, placebo-controlled trial included 75 healthy adults (18-61 years old). Subjects were randomized to receive either 1.5 or 4.5 g/day of ResistAid or placebo for 60 days. At day 30, subjects were administered both tetanus and influenza vaccines. Serum antigenic response (tetanus immunoglobulin G [IgG], influenza A and B IgG and immunoglobulin M [IgM]) was measured at days 45 (15 days after vaccination) and 60 (30 days after vaccination) of the study and compared to baseline antibody levels. Frequency and intensity of adverse events were monitored throughout the study. As expected, all 3 groups demonstrated an expected rise in tetanus IgG levels 15 and 30 days following the vaccine. There was a strongly significant difference in the rise in IgG levels at day 60 in the 1.5 g/day group compared to placebo (p = 0.008). In the 4.5 g/day group, there was significant rise in tetanus IgG at days 45 and 60 compared to baseline (p < 0.01) but these values were not significant compared to placebo. Neither group demonstrated any significant elevations in IgM or IgG antibodies compared to placebo following the influenza vaccine. There were no clinically or statistically significant or serious adverse events. ResistAid at a dose of 1.5 g/day significantly increased the IgG antibody response to tetanus vaccine compared to placebo. In conjunction with earlier studies, this validates the effect of ResistAid on the augmentation of the response to bacterial antigens (in the form of vaccine).

Informing Patients About Placebo Effects: Using Evidence, Theory, and Qualitative Methods to Develop a New Website.

Science.gov (United States)

Greville-Harris, Maddy; Bostock, Jennifer; Din, Amy; Graham, Cynthia A; Lewith, George; Liossi, Christina; O'Riordan, Tim; White, Peter; Yardley, Lucy; Bishop, Felicity L

2016-06-10

According to established ethical principles and guidelines, patients in clinical trials should be fully informed about the interventions they might receive. However, information about placebo-controlled clinical trials typically focuses on the new intervention being tested and provides limited and at times misleading information about placebos. We aimed to create an informative, scientifically accurate, and engaging website that could be used to improve understanding of placebo effects among patients who might be considering taking part in a placebo-controlled clinical trial. Our approach drew on evidence-, theory-, and person-based intervention development. We used existing evidence and theory about placebo effects to develop content that was scientifically accurate. We used existing evidence and theory of health behavior to ensure our content would be communicated persuasively, to an audience who might currently be ignorant or misinformed about placebo effects. A qualitative 'think aloud' study was conducted in which 10 participants viewed prototypes of the website and spoke their thoughts out loud in the presence of a researcher. The website provides information about 10 key topics and uses text, evidence summaries, quizzes, audio clips of patients' stories, and a short film to convey key messages. Comments from participants in the think aloud study highlighted occasional misunderstandings and off-putting/confusing features. These were addressed by modifying elements of content, style, and navigation to improve participants' experiences of using the website. We have developed an evidence-based website that incorporates theory-based techniques to inform members of the public about placebos and placebo effects. Qualitative research ensured our website was engaging and convincing for our target audience who might not perceive a need to learn about placebo effects. Before using the website in clinical trials, it is necessary to test its effects on key outcomes

Patient attitudes about the clinical use of placebo: qualitative perspectives from a telephone survey.

Science.gov (United States)

Ortiz, Robin; Chandros Hull, Sara; Colloca, Luana

2016-04-04

To examine qualitative responses regarding the use of placebo treatments in medical care in a sample of US patients.Survey studies suggest a deliberate clinical use of placebos by physicians, and prior research has found that although most US patients find placebo use acceptable, the rationale for these beliefs is largely unknown. Members of the Outpatient Clinic at the Kaiser Permanente Northern California interviewed research participants who had been seen for a chronic health problem at least once in the prior 6 months. 853 women (61%) and men, white (58%) and non-white participants aged 18-75 years. Qualitative responses on perceptions of placebo use from one-time telephone surveys were analysed for common themes and associations with demographic variables. Prior results indicated that a majority of respondents felt it acceptable for doctors to recommend placebo treatments. Our study found that a lack of harm (n=291, 46.1%) and potential benefit (n=250, 39.6%) were the most common themes to justify acceptability of placebo use. Responses citing potential benefit were associated with higher education (r=0.787; pright to know and power of the mind. Older age was associated with likelihood to cite overall physician, as opposed to treatment, related themes (r=0.753; prights-and-licensing/

Comparison of Levetiracetam and sodium Valproate in migraine prophylaxis: A randomized placebo-controlled study

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Homa Sadeghian

2015-01-01

Full Text Available Background: Migraine is a chronic and disabling disorder. Treatment of migraine often comprises of symptomatic (abortive and preventive (prophylactic treatment. The current drugs used in migraine prophylaxis include antidepressant drugs (Serotonin Reuptake Inhibitors, Tricyclic antidepressants, and anti-epileptic drugs (valproate, gabapentin, etc. Objective: The objective of our study was to assess the efficacy and tolerability of levetiracetam in adult migraine prophylaxis, compared to valproate and placebo. Materials and Methods: We conducted a prospective, randomized, placebo-controlled study. A total of 85 patients were randomized to receive levetiracetam 500 mg/d (n = 27, valproate 500 mg/d (n = 32 or placebo (n = 26. The patients were evaluated for treatment efficacy after 6 months. Efficacy was assessed as a more than 50% decrease in headache frequency. Results: In levetiracetam group, 17 (63.0% patients experienced a more than 50% decrease in headache frequency, while this efficacy number was 21 (65.6% for valproate group and 4 (15.4% for placebo group. The difference was not statistically significant between levetiracetam and valproate, while it was significant when comparing either levetiracetam or valproate to placebo. Conclusion: Compared to placebo, levetiracetam offers improvement in headache frequency in patients with migraine. The efficacy of levetiracetam in migraine prophylaxis is comparable to currently used drugs such as valproate.

Oral contraceptives induce lamotrigine metabolism: evidence from a double-blind, placebo-controlled trial

DEFF Research Database (Denmark)

Christensen, Jakob; Petrenaite, Vaiva; Attermann, Jørn

2007-01-01

and taking combination-type oral contraceptives, were randomized to treatment with placebo or a standard combination-type contraceptive pill. The dose-corrected trough plasma concentration of LTG and the ratio of N-2-glucuronide/unchanged LTG on urine after 21 days of concomitant placebo treatment...... was analyzed versus those after 21 days of concomitant treatment with the oral contraceptive pill. RESULTS: The mean dose-corrected LTG concentration after placebo treatment was 84%[95% confidence interval (CI), 45-134%] higher than after oral contraceptives, signifying an almost doubling of the concentration...

"Live high-train low" using normobaric hypoxia: a double-blinded, placebo-controlled study

DEFF Research Database (Denmark)

Siebenmann, Christoph; Robach, Paul; Jacobs, Robert A

2012-01-01

The combination of living at altitude and training near sea level [live high-train low (LHTL)] may improve performance of endurance athletes. However, to date, no study can rule out a potential placebo effect as at least part of the explanation, especially for performance measures. With the use o...... of a placebo-controlled, double-blinded design, we tested the hypothesis that LHTL-related improvements in endurance performance are mediated through physiological mechanisms and not through a placebo effect. Sixteen endurance cyclists trained for 8 wk at low altitude (...

Modeling and simulation of placebo response and dropout patterns in treatment of schizophrenia

NARCIS (Netherlands)

Pilla Reddy, Venkatesh; Kozielska, Magdalena; Johnson, Martin; Vermeulen, An; de Greef, Rik; Liu, Jing; Groothuis, Genoveva; Danhof, Meindert; Proost, Johannes

2010-01-01

Objectives: Unpredictable variation in placebo response within and among clinical trials can substantially affect conclusions about the efficacy of new antipsychotic medications. Developing a robust placebo model accounting for factors like dropouts, disease progression and trial design is crucial

Is TENS purely a placebo effect? A controlled study on chronic low back pain.

Science.gov (United States)

Marchand, S; Charest, J; Li, J; Chenard, J R; Lavignolle, B; Laurencelle, L

1993-07-01

Although high-frequency low-intensity transcutaneous electric nerve stimulation (TENS) has been extensively used to relieve low back pain, experimental studies of its effectiveness have yielded contradictory findings mainly due to methodological problems in pain evaluation and placebo control. In the present study, separate visual analog scales (VAS) were used to measure the sensory-discriminative and motivational-affective components of low back pain. Forty-two subjects were randomly assigned to 1 of 3 groups: TENS, placebo-TENS, and no treatment (control). In order to measure the short-term effect of TENS, VAS pain ratings were taken before and after each treatment session. Also, to measure long-term effects, patients rated their pain at home every 2 h throughout a 3-day period before and 1 week, 3 months and 6 months after the treatment sessions. In comparing the pain evaluations made immediately before and after each treatment session, TENS and placebo-TENS significantly reduced both the intensity and unpleasantness of chronic low back pain. TENS was significantly more efficient than placebo-TENS in reducing pain intensity but not pain unpleasantness. TENS also produced a significant additive effect over repetitive treatment sessions for pain intensity and relative pain unpleasantness. This additive effect was not found for placebo-TENS. When evaluated at home, pain intensity was significantly reduced more by TENS than placebo-TENS 1 week after the end of treatment, but not 3 months and 6 months later. At home evaluation of pain unpleasantness in the TENS group was never different from the placebo-TENS group.(ABSTRACT TRUNCATED AT 250 WORDS)

Nicotine patches in pregnant smokers: randomised, placebo controlled, multicentre trial of efficacy

Science.gov (United States)

Grangé, Gilles; Jacob, Nelly; Tanguy, Marie-Laure

2014-01-01

Objective To determine the efficacy of 16 hour nicotine patches among pregnant smokers, with the dose individually adjusted according to saliva cotinine levels (potential range 10-30 mg/day). Design Randomised, double blind, placebo controlled, parallel group, multicentre trial (Study of Nicotine Patch in Pregnancy, SNIPP) between October 2007 and January 2013. Setting 23 maternity wards in France. Participants 476 pregnant smokers aged more than 18 years and between 12 and 20 weeks’ gestation, who smoked at least five cigarettes a day. After exclusions, 402 women were randomised: 203 to nicotine patches and 199 to placebo patches. Data were available on 192 live births in each group. Interventions Nicotine and identical placebo patches were administered from quit day up to the time of delivery. Doses were adjusted to saliva cotinine levels when smoking to yield a substitution rate of 100%. Participants were assessed monthly and received behavioural smoking cessation support. Main outcome measures The primary outcomes were complete abstinence (self report confirmed by carbon monoxide level in expired air ≤8 ppm) from quit date to delivery, and birth weight. The secondary outcomes were point prevalence of abstinence, time to lapse (a few puffs) or relapse, and delivery and birth characteristics. All data were analysed on an intention to treat basis. Results Complete abstinence was achieved by 5.5% (n=11) of women in the nicotine patch group and 5.1% (n=10) in the placebo patch group (odds ratio 1.08, 95% confidence interval 0.45 to 2.60). The median time to the first cigarette smoked after target quit day was 15 days in both groups (interquartile range 13-18 in the nicotine patch group, 13-20 in the placebo patch group). The point prevalence abstinence ranged from 8% to 12.5% in the nicotine patch group and 8% to 9.5% in the placebo patch group without statistically significant differences. The nicotine substitution rate did not differ from 100%, and the self

["Placebo effect", from personal convictions to collective representations: A psychosocial reading of a pharmacodynamic phenomenon].

Science.gov (United States)

Balez, R; Couturaud, F; Touffet, L

2015-11-01

After starting with a brief historical account of the placebo effect organized around the elaboration of clinical trials and around sham therapy as a method, we will offer a psychosocial point of view on the placebo phenomenon. The placebo effect is at the heart of medicine and particularly of therapeutic trials from theoretical research on a drug to its acceptance and its use in every-day clinical practice. The placebo effect intermingles biology, relationships and the context of therapeutic interactions. This type of phenomenon originates as much from biology as from human psychology. Our article puts more precisely into question the part that psychology has in the placebo phenomenon and suggests a chart to address it. This chart refers both to the pharmacodynamic effect given to drugs in a subjective way, and to the collective representations and social interactions depending on them. What can we say about the psychosociological dimensions of the placebo effect? How is it possible to organize the scope of these dimensions to base systematic studies on them in the field of clinical trials? We try to give elements of response to these questions by suggesting the study of the placebo effect as an original field of study by necessarily mobilizing both health sciences and the human and social sciences. Copyright © 2015 Académie Nationale de Pharmacie. Published by Elsevier Masson SAS. All rights reserved.

Induction of nocebo and placebo effects on itch and pain by verbal suggestions

NARCIS (Netherlands)

Laarhoven, A.I.M. van; Vogelaar, M.L.; Wilder-Smith, O.H.G.; Riel, P.L.C.M. van; Kerkhof, P.C.M. van de; Kraaimaat, F.W.; Evers, A.W.M.

2011-01-01

Physical complaints, such as pain, can be effectively reduced by placebo effects through induction of positive expectations, or increased by nocebo effects through induction of negative expectations. In the present study, verbally induced nocebo and placebo effects on itch were experimentally

El método de la caxa entera de Juan Bautista de Herrera (1628: una visión peculiar de la partida doble? = The caxa entera method of Juan Bautista de Herrera (1628: A particular overview of double-entry bookkeeping?

Directory of Open Access Journals (Sweden)

José Julián Hernández Borreguero

2012-01-01

Full Text Available Juan Bautista de Herrera fue contador del Cabildo Catedral de Sevilla a principios del siglo XVII. En uno de esos libros realiza una introducción en la que explica la utilidad del método de la partida doble, así como los argumentos de cómo debía implantarse el nuevo método. El estudio de dichos argumentos se ha realizado tomando como referencia el primer tratado de contabilidad español escrito por Bartolomé Salvador de Solórzano (1590 dado que este recoge las características y esencia de la partida doble castellana en ese período. A continuación comienza el registro de hechos contables sin recurrir a un libro diario.Juan Bautista de Herrera was an accountant of the Cathedral Council of Sevilla at the beginning of 17th century. In one of these books Herrera made an introduction explaining the usefulness of the double-entry bookkeeping method and argued how to implement it. The aim of this paper is to analyse his arguments using Bartolome Salvador de Solorzano´s approach. Solorzano wrote the first Spanish accounting treatise in 1590, where he compiled the characteristics and essence of Spanish double-entry bookkeeping in this period. Herrera recorded in this book without using a daybook.

Suplementación con balanceado comercial en crías vacunas lactantes bajo sistema doble propósito

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Esperanza Prieto M.

2010-12-01

Full Text Available Objetivo. Evaluar el efecto que ejerce la suplementación con alimento balanceado sobre la ganancia diaria de peso (GDP y el consumo de alimento (CA en terneros lactantes y su impacto económico en una empresa ganadera manejada bajo un sistema vacuno de doble propósito, en el municipio de Sincé, Sucre–Colombia. Materiales y métodos. Se suplementaron 14 crías (6 machos y 8 Hembras entre 3 y 5 meses de edad, con alimento balanceado comercial al 1.5% del peso vivo (Tratamiento 1 y se compararon con un grupo igual sin suplementar (Tratamiento Testigo, durante 113 días en época de lluvias. La GDP y CA fueron evaluados mediante prueba t de Student. Se determinó Relación beneficio: costo y rentabilidad. Resultados. La GDP de las crías lactantes fue afectada de manera altamente significa por la suplementación con alimento balanceado comercial (p0.05, encontrándose el mismo resultado para el consumo de alimento balanceado (p>0.05 explicando así la no diferencia estadística en la GDP entre sexos. El análisis económico confirmó que la estrategia alimenticia es viable al presentarse una relación B:C del 1.1. y una rentabilidad trimestral del 9.27%. Conclusiones. La suplementación de terneros lactantes es una práctica viable, que permite obtener ganancias adicionales.

Evaluation of flurazepam and placebo on sleep disorders in childhood

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Rubens Reimão

1982-03-01

Full Text Available The clinically observed results in 40 patients, from 1 to 15 years old, presenting sleep disturbances, in a comparative and statistically approached study of flurazepam 15mg daily against placebo, are reported. Placebo was administered, followed by the drug, during 14 days each. The chief complaints were sleepwalking, sleep-talking, sleep terror, sleep-related bruxism, sleep-related headbanging, insomnia and excessive movements during sleep. A significant effect of flurazepam on sleepwalking, sleep-talking, bruxism, sleep terror and excessive movement during sleep, was observed. The insomniac and headbanging patients were not enough for statistical analysis. Flurazepam side effects were excessive drowsiness during daytime in 3 cases; irritability, 3 cases; nausea and vomiting, 2 cases, and were not correlated with age. Placebo side effects were similar, except for nausea and vomiting which were not observed. It was necessary to discontinue flurazepam in 2 cases, because of excessive drowsiness during daytime, which did not improve when reducing the dose.

Caffeine counteracts impairments in task-oriented psychomotor performance induced by chlorpheniramine: a double-blind placebo-controlled crossover study.

Science.gov (United States)

Kim, Sung-Wan; Bae, Kyung-Yeol; Shin, Hee-Young; Kim, Jae-Min; Shin, Il-Seon; Kim, Jong-Keun; Kang, Gaeun; Yoon, Jin-Sang

2013-01-01

This study aimed to evaluate the effects of chlorpheniramine on psychomotor performance and the counteracting effects of caffeine on those sedative antihistamine actions. Sixteen healthy young men participated in this study. Using a double-blind placebo-controlled crossover design, each subject was administered one of the following conditions in a random order with a one-week interval: 'placebo-placebo', '4 mg of chlorpheniramine-placebo', 'placebo-200 mg of caffeine' or '4 mg of chlorpheniramine-200 mg of caffeine'. Before and after the treatments, psychomotor functions were assessed using a battery of tests. Additionally, subjective responses were assessed using a visual analogue scale (VAS). Psychomotor performance changed over time in different ways according to the combination of study medications. In the 'chlorpheniramine-placebo' condition, reaction times of the compensatory tracking task were significantly impaired compared with the other three conditions. In addition, the number of omission errors of the continuous performance test were significantly greater compared with the 'placebo-caffeine' condition. However, the response pattern of the 'chlorpheniramine-caffeine' condition was not significantly different from that of the 'placebo-placebo' condition. Changes of VAS for sleepiness were significantly greater in the 'chlorpheniramine-placebo' condition compared with the other three conditions. In conclusion, chlorpheniramine significantly increases subjective sleepiness and objectively impairs psychomotor performance. However, caffeine counteracts these sedative effects and psychomotor impairments.

Pharmacodynamic Modelling of Placebo and Buprenorphine Effects on Event-Related Potentials in Experimental Pain

DEFF Research Database (Denmark)

Juul, Rasmus V; Foster, David J R; Upton, Richard N

2014-01-01

The purpose of the study was to investigate placebo and buprenorphine effects on event-related potentials (ERPs) in experimental pain and the potential benefit of population pharmacodynamic modelling in data analysis. Nineteen healthy volunteers received transdermal placebo and buprenorphine...... in a cross-over study. Drug plasma concentrations and ERPs after electrical stimulation at the median nerve with intensity adjusted to pain detection threshold were recorded until 144 hrs after administration. Placebo and concentration-effect models were fitted to data using non-linear mixed......, pharmacodynamic modelling was successfully implemented to allow for placebo and variability correction in ERP of experimental pain. Improved outcome of ERP studies can be expected if variation between subjects and study occasions can be identified and described....

Placebo effect of an inert gel on experimentally induced leg muscle pain

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James G Hopker

2010-11-01

Full Text Available James G Hopker1, Abigail J Foad2, Christopher J Beedie2, Damian A Coleman2, Geoffrey Leach11Centre for Sports Studies, University of Kent, Chatham, Kent, UK; 2Department of Sports Science, Tourism and Leisure, Canterbury Christ Church University, Canterbury, Kent, UKPurpose: This study examined the therapeutic effects of an inert placebo gel on experimentally induced muscle pain in a sports therapy setting. It aimed to investigate the degree to which conditioned analgesia, coupled with an expectation of intervention, was a factor in subsequent analgesia.Methods: Participants were sixteen male and eight female sports therapy students at a UK University. With institutional ethics board approval and following informed consent procedures, each was exposed to pain stimulus in the lower leg in five conditions, ie, conditioning, prebaseline, experimental (two placebo gel applications, and postbaseline. In conditioning trials, participants identified a level of pain stimulus equivalent to a perceived pain rating of 6/10. An inert placebo gel was then applied to the site with the explicit instruction that it was an analgesic. Participants were re-exposed to the pain stimulus, the level of which, without their knowledge, had been decreased, creating the impression of an analgesic effect resulting from the gel. In experimental conditions, the placebo gel was applied and the level of pain stimulus required to elicit a pain rating of 6/10 recorded.Results: Following application of the placebo gel, the level of pain stimulus required to elicit a pain rating of 6/10 increased by 8.2%. Application of the placebo gel significantly decreased participant’s perceptions of muscle pain (P = 0.001.Conclusion: Subjects’ experience and expectation of pain reduction may be major factors in the therapeutic process. These factors should be considered in the sports therapeutic environment.Keywords: conditioning, expectation, perception, positive belief, sports therapy

Lycopene in the management of oral lichen planus: A placebo-controlled study

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Nisheeth Saawarn

2011-01-01

Settings and Design: This prospective, randomized, double-blind, placebo-controlled study was done in the Oral Medicine Department of a postgraduate teaching dental hospital in India. Materials and Methods: Thirty symptomatic OLP patients, randomly divided into two groups of 15 each, were administered lycopene 8 mg/day and an identical placebo, respectively, for 8 consecutive weeks. Burning sensation using visual analogue scale and overall treatment response using Tel Aviv-San Francisco scale were recorded at every visit. The data obtained were analyzed statistically using Wilcoxon Rank test, Mann-Whitney and Fischer′s Exact test. Results: A higher (84% reduction in burning sensation was seen in lycopene than in the placebo group (67%. All 15 (100% patients in the lycopene group showed 50% or more benefit and 11 (73.3% patients showed 70-100% benefit, while this number was only 10 and 4 (26.7%, respectively, in the placebo group. Conclusion: Lycopene was very effective in the management of OLP, and oxidative stress may have a role in disease pathogenesis.

Rotura del Bíceps Distal. Evaluación de resultados con técnica de doble fijación. [Distal biceps rupture: evaluation of results with double fixation technique

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Miguel Ángel Capomassi

2013-11-01

Full Text Available In­tro­duc­ción La rotura del bíceps distal es una lesión poco frecuente producida por la aplicación de una fuerza excéntrica sobre el codo flexionado. El objetivo de este trabajo es analizar los resultados obtenidos para la reinserción del bíceps distal mediante técnica de doble fijación con botón de anclaje cortical y tornillo interferencial de biotenodesis a través de una incisión anterior única. Materiales­ y­ Métodos Entre agosto de 2008 y febrero de 2013, registramos 19 casos de rotura del bíceps distal tratados quirúrgicamente por vía anterior limitada. Los 17 últimos casos consecutivos fueron tratados con doble fijación utilizando botón extracortical y tornillo de biotenodesis, y forman parte del estudio. Todos eran hombres, con una mediana de la edad de 41 años (rango 27-59. Los pacientes fueron evaluados con el Cuestionario DASH y el Puntaje Subjetivo/Objetivo de Andrews y Carson, y la fuerza de flexión y supinación se controló con la escala del British Medical Research Council modificada por Mackinnon y Dellon (M0-M5. Resultados El cuestionario DASH arrojó un valor mediano de 1,7 (0-5,83 y el de Andrews y Carson, de 195 (170-200 para el total; con 15 resultados excelentes y 2 buenos. Todos consiguieron una fuerza M5 para flexión y supinación de antebrazo. El seguimiento tuvo una mediana de 12 meses (4-32. En dos pacientes, se registraron complicaciones, ambas con recuperación ad íntegrum. Conclusión La técnica descrita ha demostrado ser confiable y eficaz, y permitió lograr resultados satisfactorios y una baja tasa de complicaciones.

Quantifying the placebo effect in psychological outcomes of exercise training: a meta-analysis of randomized trials.

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Lindheimer, Jacob B; O'Connor, Patrick J; Dishman, Rod K

2015-05-01

The placebo effect could account for some or all of the psychological benefits attributed to exercise training. The magnitude of the placebo effect in psychological outcomes of randomized controlled exercise training trials has not been quantified. The aim of this investigation was to estimate the magnitude of the population placebo effect in psychological outcomes from placebo conditions used in exercise training studies and compare it to the observed effect of exercise training. Articles published before 1 July 2013 were located using Google Scholar, MEDLINE, PsycINFO, and The Cochrane Library. To be included in the analysis, studies were required to have (1) a design that randomly assigned participants to exercise training, placebo, and control conditions and (2) an assessment of a subjective (i.e., anxiety, depression, energy, fatigue) or an objective (i.e., cognitive) psychological outcome. Meta-analytic and multi-level modeling techniques were used to analyze effects from nine studies involving 661 participants. Hedges' d effect sizes were calculated, and random effects models were used to estimate the overall magnitude of the placebo and exercise training effects. After adjusting for nesting effects, the placebo mean effect size was 0.20 (95% confidence interval [CI] -0.02, 0.41) and the observed effect of exercise training was 0.37 (95% CI 0.11, 0.63). A small body of research suggests both that (1) the placebo effect is approximately half of the observed psychological benefits of exercise training and (2) there is an urgent need for creative research specifically aimed at better understanding the role of the placebo effect in the mental health consequences of exercise training.

Double blind, placebo-controlled trial of Tranexamic acid on recent internal hemorrhoid bleeding

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Abdul A. Rani

2002-12-01

Full Text Available Double blind randomized placebo controlled trial was conducted to evaluate the efficacy of Tranexamic acid in 54 patients with recent hemorrhoid bleeding. Age, gender, body weight, height, grade of hemorrhoid, time of onset of recent bleeding were comparable between two groups. Analysis of haemostatic effect or stop bleeding as an immediate outcome of this study revealed that in the grade 2 patients, 23/23 (100% of tranexamic group and 18/23(78.26% of placebo group the bleeding stop. After 3 days of observation, there was statistically significant different for the rate of stop bleeding as well as at the end of observation. Bleeding stop earlier in the Tranexamic group with median 4 days (3-5 days, compare to placebo, median 11(9.55-12.45. Analysis of recurrent bleeding as an outcome of this study revealed that in the placebo group 9/18(50% of grade 2 patients and all grade 3 (100%patients suffered from recurrent bleeding. Since the days 4, both group have significant different time for recurrent bleeding and at the end of observation, cumulative probability of free of bleeding between two groups significantly different. Median still stop bleeding in the placebo group was 36 days, and the tranexamic group never reaches the median until the end of observation. Conclusion: tranexamic acid was an effective drug to stop recent hemorrhoid bleeding and prevent further recurrent bleeding, significantly better than placebo. (Med J Indones 2002;11: 215-21Keywords: Tranexamic acid, hemorrhoid bleeding, haemostatic effect, recurrent bleeding.

Melatonin for chronic whiplash syndrome with delayed melatonin onset randomised, placebo-controlled trial

NARCIS (Netherlands)

Wieringen, S. van; Jansen, T.; Smits, M.G.; Nagtegaal, J.E.; Coenen, A.M.L.

2001-01-01

Objective: To assess the influence of melatonin in patients with chronic whiplash syndrome and delayed melatonin onset. Design: Randomised, double-blind, placebo-controlled, parallel-group trial. One-week baseline was followed by a 4-week treatment period with either melatonin or placebo. In the

Characteristics of Placebo Responders in Pediatric Clinical Trials of Attention-Deficit/Hyperactivity Disorder

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Newcorn, Jeffrey H.; Sutton, Virginia K.; Zhang, Shuyu; Wilens, Timothy; Kratochvil, Christopher; Emslie, Graham J.; D'Souza, Deborah N.; Schuh, Leslie M.; Allen, Albert J.

2009-01-01

Objective: Understanding placebo response is a prerequisite to improving clinical trial methodology. Data from placebo-controlled trials of atomoxetine in the treatment of children and adolescents with attention-deficit/hyperactivity disorder (ADHD) were analyzed to identify demographic and clinical characteristics that might predict placebo…

Trick or treat: The effect of placebo on the power of pharmacogenetic association studies

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Singer Clara

2005-03-01

Full Text Available Abstract The genetic mapping of drug-response traits is often characterised by a poor signal-to-noise ratio that is placebo related and which distinguishes pharmacogenetic association studies from classical case-control studies for disease susceptibility. The goal of this study was to evaluate the statistical power of candidate gene association studies under different pharmacogenetic scenarios, with special emphasis on the placebo effect. Genotype/phenotype data were simulated, mimicking samples from clinical trials, and response to the drug was modelled as a binary trait. Association was evaluated by a logistic regression model. Statistical power was estimated as a function of the number of single nucleotide polymorphisms (SNPs genotyped, the frequency of the placebo 'response', the genotype relative risk (GRR of the response polymorphism, the strategy for selecting SNPs for genotyping, the number of individuals in the trial and the ratio of placebo-treated to drugtreated patients. We show that: (i the placebo 'response' strongly affects the statistical power of association studies -- even a highly penetrant drug-response allele requires at least a 500-patient trial in order to reach 80 per cent power, several-fold more than the value estimated by standard tools that are not calibrated to pharmacogenetics; (ii the power of a pharmacogenetic association study depends primarily on the penetrance of the response genotype and, when this penetrance is fixed, power decreases for larger placebo effects; (iii power is dramatically increased when adding markers; (iv an optimal study design includes a similar number of placebo- and drugtreated patients; and (v in this setting, straightforward haplotype analysis does not seem to have an advantage over single marker analysis.

Metformin versus Placebo in Obese Pregnant Women without Diabetes Mellitus.

Science.gov (United States)

Syngelaki, Argyro; Nicolaides, Kypros H; Balani, Jyoti; Hyer, Steve; Akolekar, Ranjit; Kotecha, Reena; Pastides, Alice; Shehata, Hassan

2016-02-04

Obesity is associated with an increased risk of adverse pregnancy outcomes. Lifestyle-intervention studies have not shown improved outcomes. Metformin improves insulin sensitivity and in pregnant patients with gestational diabetes it leads to less weight gain than occurs in those who do not take metformin. In this double-blind, placebo-controlled trial, we randomly assigned pregnant women without diabetes who had a body-mass index (BMI; the weight in kilograms divided by the square of the height in meters) of more than 35 to receive metformin, at a dose of 3.0 g per day, or placebo (225 women in each group) from 12 to 18 weeks of gestation until delivery. The BMI was calculated at the time of study entry (12 to 18 weeks of gestation). The primary outcome was a reduction in the median neonatal birth-weight z score by 0.3 SD (equivalent to a 50% reduction, from 20% to 10%, in the incidence of large-for-gestational-age neonates). Secondary outcomes included maternal gestational weight gain and the incidence of gestational diabetes and of preeclampsia, as well as the incidence of adverse neonatal outcomes. Randomization was performed with the use of computer-generated random numbers. The analysis was performed according to the intention-to-treat principle. A total of 50 women withdrew consent during the trial, which left 202 women in the metformin group and 198 in the placebo group. There was no significant between-group difference in the median neonatal birth-weight z score (0.05 in the metformin group [interquartile range, -0.71 to 0.92] and 0.17 in the placebo group [interquartile range, -0.62 to 0.89], P=0.66). The median maternal gestational weight gain was lower in the metformin group than in the placebo group (4.6 kg [interquartile range, 1.3 to 7.2] vs. 6.3 kg [interquartile range, 2.9 to 9.2], Pmetformin group than in the placebo group. There were no significant between-group differences in the incidence of gestational diabetes, large

Regorafenib plus best supportive care versus placebo plus best supportive care in Asian patients with previously treated metastatic colorectal cancer (CONCUR): a randomised, double-blind, placebo-controlled, phase 3 trial.

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Li, Jin; Qin, Shukui; Xu, Ruihua; Yau, Thomas C C; Ma, Brigette; Pan, Hongming; Xu, Jianming; Bai, Yuxian; Chi, Yihebali; Wang, Liwei; Yeh, Kun-Huei; Bi, Feng; Cheng, Ying; Le, Anh Tuan; Lin, Jen-Kou; Liu, Tianshu; Ma, Dong; Kappeler, Christian; Kalmus, Joachim; Kim, Tae Won

2015-06-01

In the international randomised phase 3 CORRECT trial (NCT01103323), regorafenib significantly improved overall survival versus placebo in patients with treatment-refractory metastatic colorectal cancer. Of the 760 patients in CORRECT, 111 were Asian (mostly Japanese). This phase 3 trial was done to assess regorafenib in a broader population of Asian patients with refractory metastatic colorectal cancer than was studied in CORRECT. In this randomised, double-blind, placebo-controlled, parallel-group, phase 3 trial done in 25 hospitals in mainland China, Hong Kong, South Korea, Taiwan, and Vietnam, we recruited Asian patients aged 18 years or older with progressive metastatic colorectal cancer who had received at least two previous treatment lines or were unable to tolerate standard treatments. Patients had to have an Eastern Cooperative Oncology Group performance status of 0 or 1, life expectancy of at least 3 months, and adequate bone marrow, liver, and renal function, without other uncontrolled medical disorders. We randomly allocated patients (2:1; with a computer-generated unicentric randomisation list [prepared by the study funder] and interactive voice response system; block size of six; stratified by metastatic site [single vs multiple organs] and time from diagnosis of metastatic disease [regorafenib 160 mg once daily or placebo on days 1-21 of each 28 day cycle; patients in both groups were also to receive best supportive care. Participants, investigators, and the study funder were masked to treatment assignment. The primary endpoint was overall survival, and we analysed data on an intention-to-treat basis. This trial is registered with ClinicalTrials.gov, number NCT01584830. Between April 29, 2012, and Feb 6, 2013, we screened 243 patients and randomly assigned 204 patients to receive either regorafenib (136 [67%]) or placebo (68 [33%]). After a median follow-up of 7·4 months (IQR 4·3-12·2), overall survival was significantly better with regorafenib

Greater incidence of depression with hypnotic use than with placebo

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Kripke Daniel F

2007-08-01

Full Text Available Abstract Background Although it has been claimed that insomnia causes an increased risk for depression, adequate controlled trials testing this hypothesis have not been available. This study contrasted the incidence of depression among subjects receiving hypnotics in randomized controlled trials versus those receiving placebo. Methods The incidence of depression among patients randomized to hypnotic drugs or placebo was compiled from prescribing information approved by the United States Food and Drug Administration (FDA and from FDA New Drug Application documents. Available data for zolpidem, zaleplon, eszopiclone, and ramelteon were accessed. Results Data for 5535 patients randomized to a hypnotic and for 2318 randomized to placebo were compiled. The incidence of depression was 2.0% among participants randomized to hypnotics as compared to 0.9% among those randomized in parallel to placebo (p Conclusion Modern hypnotics were associated with an increased incidence of depression in data released by the FDA. This suggests that when there is a risk of depression, hypnotics may be contra-indicated. Preventive treatments such as antidepressant drugs, cognitive-behavioral therapy, or bright light might be preferred. Limitations in the FDA data prevented a formal meta-analysis, and there was a lack of information about drop-out rates and definitions of depression. Trials specifically designed to detect incident depression when treating insomnia with hypnotic drugs and better summarization of adverse events in trials submitted to the FDA are both necessary.

Safety of Flibanserin in Women Treated With Antidepressants: A Randomized, Placebo-Controlled Study.

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Clayton, Anita H; Croft, Harry A; Yuan, James; Brown, Louise; Kissling, Robert

2018-01-01

Depression is often associated with sexual dysfunction, and pharmacologic treatment for hypoactive sexual desire disorder can be considered in women receiving treatment for depression. To evaluate the safety of flibanserin in women treated for depression with selective serotonin reuptake inhibitors or serotonin and norepinephrine reuptake inhibitors. In this double-blinded, randomized, placebo-controlled trial, women with remitted or mild depression treated with selective serotonin reuptake inhibitors or serotonin and norepinephrine reuptake inhibitors who were not postmenopausal and were experiencing symptoms of hypoactive sexual desire disorder (ie, decreased sexual desire and related distress) received flibanserin 50 mg at bedtime (qhs) for 2 weeks and up-titrated to 100 mg qhs, flibanserin 100 mg qhs for the entire treatment period, or placebo for up to 12 weeks. Safety assessment included adverse events and symptoms of depression and anxiety. 73 patients were randomly assigned to flibanserin (both dose groups combined) and 38 to placebo. The sponsor terminated the study early at discontinuation of the development of flibanserin. Treatment duration was at least 8 weeks for 84.9% and 94.7% of patients in the flibanserin and placebo groups, respectively. The most common adverse events (incidence ≥ 2% in the flibanserin group and higher than that in the placebo group) included dry mouth (5.5% for flibanserin vs 2.6% for placebo), insomnia (5.5% vs 2.6%), back pain (4.1% vs 2.6%), and dizziness (4.1% vs 0.0%). There were no serious adverse events and no instances of suicidal ideation or behavior. The proportions of patients with symptom worsening in the flibanserin and placebo groups, respectively, were 6.9% and 21.6% for depression and 1.4% and 2.7% for anxiety. Remission of depression at study end point, as measured by the Quick Inventory of Depressive Symptomatology-Self Report, was experienced by 19.4% of flibanserin-treated patients and 10.8% of patients

Melatonin for sedative withdrawal in older patients with primary insomnia: a randomized double-blind placebo-controlled trial

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Lähteenmäki, Ritva; Puustinen, Juha; Vahlberg, Tero; Lyles, Alan; Neuvonen, Pertti J; Partinen, Markku; Räihä, Ismo; Kivelä, Sirkka-Liisa

2014-01-01

Aim We compared the efficacy of melatonin and placebo as adjuvants in the withdrawal of patients from long term temazepam, zopiclone or zolpidem (here ‘BZD’) use. Methods A double-blind, placebo-controlled, randomized trial was conducted in a primary health care outpatient clinic. Ninety-two men or women (≥55 years) with primary insomnia and chronic BZD use received controlled release melatonin 2 mg (CRM) (n = 46) or placebo (n = 46) during the 1 month withdrawal from BZDs. Psychosocial support was provided. Follow-up continued for up to 6 months. Successful BZD withdrawal by the end of 1 month was confirmed by BZD plasma determinations, while reduction in BZD use and abstinence continuing for 6 months were noted. Results There were two drop-outs on CRM and one on placebo. After a 1 month withdrawal, 31 participants (67%; 95% CI 54, 81) on CRM and 39 (85%; 74, 95) on placebo had withdrawn completely (intention-to-treat analysis between groups, P = 0.051; per protocol P = 0.043). Reduction in BZD use was similar or even more rare in the CRM than in the placebo group (P = 0.052 per protocol). After 6 months, 14 participants in the CRM group and 20 in the placebo group remained non-users of BZD (NS between groups). BZD doses were higher in the CRM than in the placebo group at the end of the 6 month follow-up (P = 0.025). Withdrawal symptoms did not differ between the groups. Conclusions Gradual dose reduction of BZDs combined with CRM or placebo, and psychosocial support produced high short term and moderate long term BZD abstinence. CRM showed no withdrawal benefit compared with placebo. PMID:24286360

A survey of patient preferences for a placebo orodispersible tablet

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Wade AG

2012-03-01

Full Text Available Alan G Wade1, Gordon M Crawford1, David Young21CPS Research, Glasgow, UK; 2Department of Mathematics and Statistics, University of Strathclyde, Glasgow, Scotland, UKAim: To assess the attitudes and preferences of patients currently being treated for depression or anxiety disorders with traditional oral antidepressants relative to a placebo orodispersible (ODT formulation of escitalopram.Methods: This was an open study collecting patient-reported outcome data from patients with anxiety or depression that were treated with oral antidepressant medication on Day 0 before and after receiving a single placebo ODT, and on Day 3 or 4 after receiving two further daily doses of placebo ODT. Patients aged 18–80 years who were currently receiving treatment with oral antidepressants were recruited from general practice and by advertising. Patients with significant symptoms of anxiety or depression (scoring ≥9 on either the depression or anxiety subscales of the Hospital Anxiety and Depression Scale were included in the study.Results: A total of 150 patients were enrolled in and completed the study. About 37% of the patients had had trouble with swallowing tablets, and patients with higher depression scores reported more general swallowing problems than those with lower scores (P = 0.002. Most patients (75.3% believed that an ODT might work faster but that it would make no difference to the effectiveness of the medication (63.1% or the number of side effects (81.3%. About 96% of the patients reported experiencing a pleasant taste following the placebo ODT, although seven patients did not like its taste or aftertaste. This study found that 80.7% of patients reported that the tablets were easy or very easy to get out of the packaging.Conclusion: Based on the results of the placebo version of escitalopram ODT, the escitalopram ODT is likely to be well accepted by patients suffering from anxiety or depressive symptoms.Keywords: ODT, swallowing difficulties

Can homeopathically prepared mercury cause symptoms in healthy volunteers? A randomized, double-blind placebo-controlled trial.

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Vickers, A J; van Haselen, R; Heger, M

2001-04-01

To pilot a method for determining whether homeopathically prepared mercury causes more symptoms (a "drug proving") in healthy volunteers than placebo. One hundred and eighteen (118) healthy volunteers ages 18 to 65 were recruited by local advertising. Subjects unfamiliar with homeopathy undertook a 1-week single-blind placebo run-in, a 1-week of double-blind, randomized treatment on either homeopathically prepared mercury 12C or placebo, and a third week of placebo run-out. Each day, symptoms were recorded on a checklist that included both true mercury symptoms and symptoms not expected to be caused by mercury (false symptoms). Additional symptoms were assessed by open reporting. Outcome was assessed by calculating a score for each day as the number of true symptoms minus the number of false symptoms. The mean score during placebo was then subtracted from the mean score for weeks two and three of the trial. Fourteen (14) subjects dropped out during placebo run-in. The remaining 104 completed the trial. Baseline comparability was good. Mean difference score was -0.125 (SD 3.47) for mercury and -0.221 (SD 3.01) for placebo (p > 0.2). No significant differences between groups were found for the number of subjects meeting predefined criteria for a drug-proving reaction. This pilot study failed to find evidence that mercury 12C causes significantly more symptoms in healthy volunteers than placebo. Questionnaires with a limited number of gross symptoms do not seem to be an appropriate methodological technique in drug proving research. If drug-proving phenomena exist, they appear to be rare.

Varenicline for treatment of alcohol dependence: a randomized, placebo-controlled trial.

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de Bejczy, Andrea; Löf, Elin; Walther, Lisa; Guterstam, Joar; Hammarberg, Anders; Asanovska, Gulber; Franck, Johan; Isaksson, Anders; Söderpalm, Bo

2015-11-01

Alcohol dependence is a devastating illness affecting a large population, and new pharmacological treatments with good efficacy are greatly needed. One potential candidate is varenicline, a smoking cessation agent with partial agonist action at α4 β2 nicotinic acetylcholine receptors. A total of 160 subjects, 30 to 70 years of age, fulfilling DSM-IV criteria for alcohol dependence without any serious physical or mental disorders, were recruited through advertisement at 3 university clinics in Sweden during March 2009 to January 2011. After a 2-week placebo run-in period, subjects received 2 mg varenicline daily (titrated from 0.5 mg during first week) or placebo for 12 weeks in a double-blind manner. The primary outcome was the proportion of heavy drinking days, measured by self-reported alcohol consumption. Primary and secondary outcomes were calculated as a mean over the 10-week steady-state active treatment period. In the primary outcome analysis, no effect of varenicline over placebo was found (p = 0.73 for the intention to treat [ITT] and 0.92 for per protocol [PP]). Secondary outcome analysis found a significant reduction of specific alcohol marker phosphatidylethanol (PEth) in the blood in the varenicline group compared to placebo (p = 0.02 ITT). Craving (p = 0.048 PP) and Alcohol Use Disorders Identification Test (AUDIT) scores (p = 0.015 ITT) were also reduced in the active treatment group. PEth more strongly correlated with self-reported alcohol consumption than carbohydrate-deficient ttransferrin and γ-glutamyl transferase, and correlation coefficients were higher in the varenicline group than in the placebo group for all markers. Although the results of the main outcome of this study did not support an effect of varenicline in alcohol-dependent individuals, the secondary analyses of PEth, craving and AUDIT score support an effect of varenicline on alcohol consumption. The disclosure of a treatment effect and the lack of a clear placebo effect when

Flecainide in Amyotrophic Lateral Sclerosis as a Neuroprotective Strategy (FANS): A Randomized Placebo-Controlled Trial.

Science.gov (United States)

Park, Susanna B; Vucic, Steve; Cheah, Benjamin C; Lin, Cindy S-Y; Kirby, Adrienne; Mann, Kristy P; Zoing, Margie C; Winhammar, Jennica; Kiernan, Matthew C

2015-12-01

Abnormalities in membrane excitability and Na(+) channel function are characteristic of amyotrophic lateral sclerosis (ALS). We aimed to examine the neuroprotective potential, safety and tolerability of the Na(+) channel blocker and membrane stabiliser flecainide in ALS. A double-blind, placebo-controlled, randomised clinical trial of flecainide (200 mg/day) for 32-weeks with a 12-week lead-in phase was conducted in participants with probable or definite ALS recruited from multiple Australian centres (ANZCT Registry number ACTRN12608000338369). Patients were reviewed by a cardiologist to rule out cardiac contraindications. Participants were randomly assigned (1:1) to flecainide or placebo using stratified permuted blocks by a central pharmacy. The primary outcome measure was the slope of decline of the ALS Functional Rating Scale-revised (ALS FRS-r) during the treatment period. Between March 11, 2008 and July 1, 2010, 67 patients were screened, 54 of whom were randomly assigned to receive flecainide (26 patients) or placebo (28 patients). Four patients in the flecainide group and three patients in the placebo group withdrew from the study. One patient in the flecainide group died during the study, attributed to disease progression. Flecainide was generally well tolerated, with no serious adverse events reported in either group. There was no significant difference in the rate of decline in the primary outcome measure ALS-FRS-r between placebo and flecainide treated patients (Flecainide 0.65 [95% CI 0.49 to 0.98]; Placebo 0.81 [0.49 to 2.12] P = 0.50). However, the rate of decline of the neurophysiological index was significantly reduced in the flecainide group (Flecainide 0.06 [0.01 to 0.11]; Placebo 0.14 [0.09 to 0.19], P = 0.02). Placebo-treated patients demonstrated greater CMAP amplitude reduction during the course of the study in the subset of patients with a reduced baseline CMAP amplitude (Flecainide: - 15 ± 12%; Placebo - 59 ± 12%; P = 0.03). Flecainide

Tratamento farmacológico de acatisia induzida por antipsicóticos Pharmacological treatment of neuroleptic-induced akathisia

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Adriano Resende Lima

2001-06-01

Full Text Available INTRODUÇÃO: A acatisia induzida por antipsicóticos é um transtorno de movimento relacionado ao sistema motor e caracterizado por sensação subjetiva de inquietude interna, irritabilidade ou disforia que podem ser intensas. Associa-se à sensação física e objetiva de desassossego e a movimentos não discinéticos. Esse efeito adverso pode predispor à pobre adesão ao tratamento e, conseqüentemente, favorecer recaídas. Assim, a escolha do melhor tratamento contribui para o alívio do sofrimento dos pacientes e favorece o melhor prognóstico. OBJETIVOS: Avaliar a eficácia e a tolerabilidade dos betabloqueadores, benzodiazepínicos e anticolinérgicos, comparados ao placebo e entre si, no tratamento de acatisia induzida por antipsicóticos, independente de idade ou diagnóstico psiquiátrico. MÉTODOS: Todos os estudos controlados, obtidos a partir das estratégias de busca que compararam betabloqueadores de ação central, benzodiazepínicos ou anticolinérgicos ao placebo e entre si, independente de sexo, idade ou diagnóstico psiquiátrico, foram considerados para esta atualização. Até março de 1999, foram consultadas sete bases de dados eletrônicos, sendo também examinadas as referências bibliográficas dos artigos selecionados. RESULTADOS: São apresentados 22 estudos controlados, sendo 13 comparando betabloqueadores, benzodiazepínicos e anticolinérgicos ao placebo e nove comparando diretamente as intervenções entre si. CONCLUSÕES: As três intervenções farmacológicas demonstraram eficácia superior comparadas ao placebo. Betabloqueadores de ação central mostraram-se mais eficazes, quando comparados a betabloqueadores de ação periférica, benzodiazepínicos e anticolinérgicos.INTRODUCTION: Neuroleptic-induced akathisia is a movement disorder related to the motor system characterized by complaints of inner restlessness, mental uneasiness, or dysphoria, all of which can be intense. Restlessness and non

Placebo neural systems: nitric oxide, morphine and the dopamine brain reward and motivation circuitries.

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Fricchione, Gregory; Stefano, George B

2005-05-01

Evidence suggests that the placebo response is related to the tonic effects of constitutive nitric oxide in neural, vascular and immune tissues. Constitutive nitric oxide levels play a role in the modulation of dopamine outflow in the nigrostriatal movement and the mesolimbic and mesocortical reward and motivation circuitries. Endogenous morphine, which stimulates constitutive nitric oxide, may be an important signal molecule working at mu receptors on gamma aminobutyric acid B interneurons to disinhibit nigral and tegmental dopamine output. We surmise that placebo induced belief will activate the prefrontal cortex with downstream stimulatory effects on these dopamine systems as well as on periaqueductal grey opioid output neurons. Placebo responses in Parkinson's disease, depression and pain disorder may result. In addition, mesolimbic/mesocortical control of the stress response systems may provide a way for the placebo response to benefit other medical conditions.

Intermittent or daily montelukast versus placebo for episodic asthma in children.

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Valovirta, Erkka; Boza, Maria L; Robertson, Colin F; Verbruggen, Nadia; Smugar, Steven S; Nelsen, Linda M; Knorr, Barbara A; Reiss, Theodore F; Philip, George; Gurner, Deborah M

2011-06-01

No standard, optimal treatment exists for severe intermittent (ie, episodic) asthma in children. However, evidence suggests that both daily and episode-driven montelukast are effective for this phenotype. To assess the regimen-related efficacy of montelukast in treating pediatric episodic asthma. A multicenter, randomized, double-blind, double-dummy, parallel-group, 52-week study was performed in children 6 months to 5 years of age comparing placebo with two regimens of montelukast 4 mg: (1) daily; or (2) episode-driven for 12 days beginning with signs/symptoms consistent with imminent cold or breathing problem. The main outcome measure was the number of asthma episodes (symptoms requiring treatment) culminating in an asthma attack (symptoms requiring physician visit, emergency room visit, corticosteroids, or hospitalization). Five hundred eighty-nine patients were randomized to daily montelukast, 591 to intermittent montelukast, and 591 to placebo. Compared with placebo, no significant difference was seen between daily montelukast (P = .510) or intermittent montelukast (P = .884) in the number of asthma episodes culminating in an asthma attack over 1 year. Daily montelukast reduced symptoms over the 12-day treatment period of asthma episodes compared with placebo (P = .045). Beta-agonist use was reduced with both daily (P = .048) and intermittent montelukast (P = .028) compared with placebo. However, because of prespecified rules for multiplicity adjustments (requiring a positive primary endpoint), statistical significance for secondary endpoints cannot be concluded. All treatments were well tolerated. Montelukast did not reduce the number of asthma episodes culminating in an asthma attack over 1 year in children 6 months to 5 years of age, although numerical improvements occurred in some endpoints. Copyright © 2011 American College of Allergy, Asthma & Immunology. Published by Elsevier Inc. All rights reserved.

The application of Reiki in nurses diagnosed with Burnout Syndrome has beneficial effects on concentration of salivary IgA and blood pressure Una sesión de Reiki en enfermeras diagnosticadas con síndrome de Burnout tiene efectos beneficiosos sobre la concentración de IgA salival y la presión arterial Uma sessão de Reiki em enfermeiras diagnosticadas com síndrome de Burnout tem efeitos benéficos sobre a concentração de IgA salivar e a pressão arterial

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Lourdes Díaz-Rodríguez

2011-10-01

Full Text Available This study aimed to investigate the immediate effects of the secretory immunoglobulin A (sIgA, α-amylase activity and blood pressure levels after the application of a Reiki session in nurses with Burnout Syndrome. A randomized, double-blind, placebo-controlled, crossover design was conducted to compare the immediate effects of Reiki versus control intervention (Hand-off sham intervention in nurses with Burnout Syndrome. Sample was composed of eighteen nurses (aged 34-56 years with burnout syndrome. Participants were randomly assigned to receive either a Reiki treatment or a placebo (sham Reiki treatment, according to the established order in two different days. The ANOVA showed a significant interaction time x intervention for diastolic blood pressure (F=4.92, P=0.04 and sIgA concentration (F=4.71, P=0.04. A Reiki session can produce an immediate and statistically significant improvement in sIgA concentration and diastolic blood pressure in nurses with Burnout Syndrome.El objetivo fue investigar los efectos inmediatos en inmunoglobulina A salival (IgAs, actividad de α-amilasa y presión arterial de una aplicación de reiki en enfermeras sufriendo síndrome de Burnout. Se utilizó un ensayo preliminar placebo randomizado con cegamiento doble utilizando un diseño cruzado. Dieciocho enfermeras (edad 34-56 con síndrome de Burnout participaron en el estudio. Las participantes recibieron tratamiento con Reiki o Reiki fingido según el orden establecido por la randomización en dos días distintos. El test de ANOVA mostró un interacción significativa momento intervención para la presión arterial diastólica (F=4.92, P=0.04 a y la concentración de sIgA (F=4.71, P=0.04. Una sesión de Reiki de 30 minutos puede mejorar de manera inmediata la respuesta de IgAs y la presión arterial diastólica en enfermeras con síndrome de Burnout.O objetivo deste estudo foi investigar os efeitos imediatos na imunoglobulina A salivar (IgAs, na atividade de �

Effect of aromatherapy massage on menopausal symptoms: a randomized placebo-controlled clinical trial.

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Darsareh, Fatemeh; Taavoni, Simin; Joolaee, Soodabeh; Haghani, Hamid

2012-09-01

Menopause is a significant event in most women's lives because it marks the end of a woman's natural reproductive life. The purpose of this study was to determine the effect of aromatherapy massage on menopausal symptoms. A randomized placebo-controlled clinical trial was conducted at a menopausal clinic at a gynecology hospital in Tehran. The study population comprised 90 women who were assigned to an aromatherapy massage group, a placebo massage group, or a control group. Each participant in the aromatherapy massage group received 30-minute aromatherapy treatment sessions twice a week for 4 weeks with aroma oil, whereas participants in the placebo massage group received the same treatment with plain oil. No treatment was provided to participants in the control group. The outcome measures in this study were menopausal symptoms, as obtained through the Menopause Rating Scale. The mean baseline level of the menopausal score did not differ among all groups. However, after eight sessions of intervention, the Menopause Rating Scale score differed significantly among the three groups (P aromatherapy massage group and the placebo massage group had a lower menopausal score than the control group (P aromatherapy massage and the placebo massage groups were compared, the menopausal score for the aromatherapy massage group was found to be significantly lower (P aromatherapy massage were effective in reducing menopausal symptoms. However, aromatherapy massage was more effective than only massage.

A randomized, placebo-controlled study of zonisamide to prevent olanzapine-associated weight gain.

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McElroy, Susan L; Winstanley, Erin; Mori, Nicole; Martens, Brian; McCoy, Jessica; Moeller, Dianna; Guerdjikova, Anna I; Keck, Paul E

2012-04-01

Weight gain is commonly observed with olanzapine treatment. Zonisamide is an antiepileptic drug associated with weight loss. This study examined the effectiveness of zonisamide in preventing weight gain in 42 patients beginning olanzapine for bipolar disorder or schizophrenia. Each patient had a body mass index of 22 mg/kg or greater and was randomized to taking olanzapine with either zonisamide (n = 20) or placebo (n = 22) for 16 weeks. The primary outcome measure was change in body weight in kilograms from baseline. In the primary analysis using longitudinal regression, patients who received zonisamide had a significantly slower rate of weight gain and increase in body mass index than those who received placebo. The patients treated with zonisamide gained a mean (SD) of 0.9 (3.3) kg, whereas those treated with placebo gained a mean (SD) of 5.0 (5.5) kg; P = 0.01. None of the patients in the zonisamide group, compared with 7 patients (33%) in the placebo group, gained 7% of body weight or greater from baseline (Fisher exact test, P = 0.009). The zonisamide group, however, reported significantly more cognitive impairment as an adverse event than the placebo group (25% vs 0, respectively; P = 0.02). Zonisamide was effective for mitigating weight gain in patients with bipolar disorder or schizophrenia initiating treatment with olanzapine but was associated with cognitive impairment as an adverse event.

A virtual experimenter to increase standardization for the investigation of placebo effects

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Bjoern Horing

2016-07-01

Full Text Available Abstract Background Placebo effects are mediated by expectancy, which is highly influenced by psychosocial factors of a treatment context. These factors are difficult to standardize. Furthermore, dedicated placebo research often necessitates single-blind deceptive designs where biases are easily introduced. We propose a study protocol employing a virtual experimenter – a computer program designed to deliver treatment and instructions – for the purpose of standardization and reduction of biases when investigating placebo effects. Methods To evaluate the virtual experimenter’s efficacy in inducing placebo effects via expectancy manipulation, we suggest a partially blinded, deceptive design with a baseline/retest pain protocol (hand immersions in hot water bath. Between immersions, participants will receive an (actually inert medication. Instructions pertaining to the medication will be delivered by one of three metaphors: The virtual experimenter, a human experimenter, and an audio/text presentation (predictor “Metaphor”. The second predictor includes falsely informing participants that the medication is an effective pain killer, or correctly informing them that it is, in fact, inert (predictor “Instruction”. Analysis will be performed with hierarchical linear modelling, with a sample size of N = 50. Results from two pilot studies are presented that indicate the viability of the pain protocol (N = 33, and of the virtual experimenter software and placebo manipulation (N = 48. Discussion It will be challenging to establish full comparability between all metaphors used for instruction delivery, and to account for participant differences in acceptance of their virtual interaction partner. Once established, the presence of placebo effects would suggest that the virtual experimenter exhibits sufficient cues to be perceived as a social agent. He could consequently provide a convenient platform to investigate effects of

The antidepressant debate and the balanced placebo trial design: an ethical analysis.

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Waring, Duff R

2008-12-01

There is ongoing debate about whether randomized, placebo-controlled trials under a double-blind have reliably established the pharmacological efficacy of antidepressants. Numerous meta-analyses of antidepressant efficacy trials, e.g., Kirsch et al. [Kirsch, I., Moore, T. J., Scoboria, A., & Nicholls, S. (2002). The emperor's new drugs: An analysis of antidepressant medication data submitted to the U.S. food and drug administration. Prevention and Treatment, 5, Article 23. (Retrieved July 19, 2007 from http://journals.apa.org/prevention/volume5)], have shown a modest drug-placebo difference but methodological problems with standard trial design preclude a definitive conclusion that this difference results from specific biological effects of antidepressants or the nonspecific factors that have not been adequately excluded. Standard trial design assumes the additivity thesis of pharmacological efficacy, being the assumption that the specific or "true" magnitude of the pharmacological effect is limited to the difference between the drug and placebo responses in a standard trial. If the drug effects are as small as these meta-analyses suggest, then their clinical effectiveness is questionable. If the drug effects are actually larger but masked by placebo effects, then the additivity thesis is not valid and we risk false negative results with standard trial design. Kirsch et al. propose an alternative, four arm balanced placebo trial design (BPTD) that can accurately test the additivity thesis. The BPTD uses antidepressants, active placebos and the intentional deception of research subjects. My focal question is whether the BPTD is ethically defensible. I will explore two objections that can be raised against it: 1) lying to BPTD research subjects violates their autonomy and exploits their illness and 2) the BPTD may not enable us to test the additivity thesis with accuracy, i.e., it may contribute to the masking of drug effects that it aims to avoid. I argue that these

Prolonged-release melatonin versus placebo for benzodiazepine discontinuation in patients with schizophrenia or bipolar disorder

DEFF Research Database (Denmark)

Baandrup, Lone; Lindschou, Jane; Winkel, Per

2016-01-01

OBJECTIVES: We assessed if prolonged-release melatonin can facilitate withdrawal of long-term benzodiazepine usage in patients with schizophrenia or bipolar disorder. METHODS: Randomised, placebo-controlled, blinded, parallel superiority trial of 24 weeks duration. Participants were randomised...... to prolonged-release melatonin 2 mg daily versus matching placebo and were continuously guided to gradually reduce their usual benzodiazepine dosage. The primary outcome was mean benzodiazepine daily dosage at 24 weeks. Secondary outcomes included pattern of benzodiazepine dosage over time, benzodiazepine...... cessation proportion, and benzodiazepine withdrawal symptoms. RESULTS: In total, 86 patients (21-74 years) were enrolled: 42 were randomised to melatonin versus 44 to placebo. We found no significant effect of melatonin on mean benzodiazepine dosage at 24 weeks (melatonin group 8.01 mg versus placebo group...

Acupuncture versus paroxetine for the treatment of premature ejaculation: a randomized, placebo-controlled clinical trial.

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Sunay, Didem; Sunay, Melih; Aydoğmuş, Yasin; Bağbancı, Sahin; Arslan, Hüseyin; Karabulut, Ayhan; Emir, Levent

2011-05-01

Acupuncture therapy has been used by many researchers in both male and female sexual dysfunction studies. To determine whether acupuncture is effective as a premature ejaculation (PE) treatment compared with paroxetine and placebo. The study was conducted with methodologic rigor based on Consolidated Standards of Reporting Trials (CONSORT) criteria. Ninety patients referred to the urology clinic at a tertiary training and research hospital with PE were included in this randomized controlled trial and randomly assigned into paroxetine, acupuncture, and placebo groups. Heterosexual, sexually active men aged between 28 and 50 yr were included. Men with other sexual disorders, including erectile dysfunction; with chronic psychiatric or systemic diseases; with alcohol or substance abuse; or who used any medications were excluded. The medicated group received paroxetine 20 mg/d; the acupuncture or sham-acupuncture (placebo) groups were treated twice a week for 4 wk. Intravaginal ejaculation latency times (IELTs) and the Premature Ejaculation Diagnostic Tool (PEDT) were used to assess PE. IELTs were calculated by using a partner-held stopwatch. Data were analyzed statistically. Median PEDT scores of paroxetine, acupuncture, and placebo groups were 17.0, 16.0, and 15.5 before treatment, and 10.5, 11.0, and 16.0 after treatment, respectively (p=0.001, p=0.001, and p=0.314, respectively). Subscores after treatment were significantly lower than subscores before treatment in the paroxetine and acupuncture groups but remained the same in the placebo group. Significant differences were found between mean-rank IELTs of the paroxetine and placebo groups (p=0.001) and the acupuncture and placebo groups (p=0.001) after treatment. Increases of IELTs with paroxetine, acupuncture, and placebo acupuncture were 82.7, 65.7, and 33.1 s, respectively. Extent of ejaculation delay induced by paroxetine was significantly higher than that of acupuncture (p=0.001). The most important limitation

Fauna silvestre asociada a ganado vacuno doble propósito en sistema de silvopastoreo, Pinto, Magdalena, Colombia

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Jaime De La Ossa V.

2011-12-01

Full Text Available Objetivo. Evaluar la biodiversidad faunística asociada a ganadería vacuna de doble propósito en dos potreros estructurados con Botriochloa pertusa (colosoana como herbácea dominante, uno de ellos plantado con Crescentia cujete (Bignoniaceae como fuente de alimento adicional y otro con escaso y disperso arbolado. Materiales y métodos. El área de estudio está ubicada en el municipio de Pinto, Magdalena. Cada potrero evaluado fue de 10 ha, se mantuvo en cada uno un lote de quince vacas (½ Cebú, ¼ Pardo y ¼ Costeño con Cuernos, la separación entre las áreas muestreadas fue de 500m. Los registros de fauna se condujeron mediante punto fijo de conteo, en diez sitios de avistamiento, durante 20 días continuos, con cubrimiento visual amplio. Al ganado vacuno adulto presente en las dos áreas de trabajo se le realizó un pesaje individual al inicio del trabajo y al final del mismo, con el fin de determinar posibles diferencias entre ellos. Resultados. Estadísticamente el número de individuos y el número de especies presentaron diferencias significativas, siendo mayor la diversidad biológica para el potrero que poseía la plantación de C. cujete, mientras que el peso corporal de las vacas sometidas a pastoreo en las dos áreas no presentó diferencias significativas. Conclusiones. Se demuestra la importancia de este modelo pecuario como promotor de la conservación faunística local al convertirse enrefugio de variadas especies silvestres, al tiempo que mantiene la productividad existente sin alterar el ambiente sustancialmente.

Treatment for the premenstrual syndrome with agnus castus fruit extract: prospective, randomised, placebo controlled study.

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Schellenberg, R

2001-01-20

To compare the efficacy and tolerability of agnus castus fruit (Vitex agnus castus L extract Ze 440) with placebo for women with the premenstrual syndrome. Randomised, double blind, placebo controlled, parallel group comparison over three menstrual cycles. General medicine community clinics. 178 women were screened and 170 were evaluated (active 86; placebo 84). Mean age was 36 years, mean cycle length was 28 days, mean duration of menses was 4.5 days. Agnus castus (dry extract tablets) one tablet daily or matching placebo, given for three consecutive cycles. Main efficacy variable: change from baseline to end point (end of third cycle) in women's self assessment of irritability, mood alteration, anger, headache, breast fullness, and other menstrual symptoms including bloating. Secondary efficacy variables: changes in clinical global impression (severity of condition, global improvement, and risk or benefit) and responder rate (50% reduction in symptoms). Improvement in the main variable was greater in the active group compared with placebo group (Pagnus castus fruit is an effective and well tolerated treatment for the relief of symptoms of the premenstrual syndrome.

Comparison of rimonabant and sibutramine treatment effects on food compulsion in rats Comparação do efeito do rimonabanto e da sibutramina no tratamento da compulsão alimentar em ratos

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Honório Sampaio Menezes

2009-12-01

Full Text Available PURPOSE: To compare the therapeutic effect of rimonabant, a new drug which is a selective antagonist of CB1 receptors, with the sibutramine. METHODS: It is an experimental clinical trial, prospective, placebo controlled. Our test was performed in 38 rats, adults females with a hyper caloric diet. We collected their blood 3 times and weighted them once a week. We divided the rats in 3 groups: Rimonabant, Sibutramine and Control. Statistic analysis has been made through ANOVA test, Tukey test and t Student test. RESULTS: The Rimonabant group demonstrated a significant reduction of the weight increase in rats. The Sibutramine group showed a significant reduction on blood glycemia compared to Rimonabant group and Control group. CONCLUSIONS: Rimonabant showed to be more effective than Sibutramine by decreasing weight gain. Sibutramine has been more effective than Rimonabant and Control groups by decreasing the blood glycemia.OBJETIVO: Comparar o efeito do rimonabanto, nova droga seletivamente antagonista dos receptores CB1, com a sibutramina. MÉTODOS: Ensaio clínico experimental, prospectivo, placebo controlado. Realizado com 38 ratas, adultas, submetidas a dieta hipercalórica. Foram coletadas 3 amostras de sangue e o peso controlado semanalmente. Foram divididas em 3 grupos: Rimonabanto, Sibutramina e Controle. Analise estatística realizada com ANOVA, teste t de Student e teste de Tukey. RESULTADOS: O grupo Rimonabanto obteve redução significante do ganho de peso. O grupo Sibutramina teve redução significativa da glicemia quando comparado aos demais grupos. CONCLUSÕES: Rimonabanto foi mais efetivo que a Sibutramina na redução do ganho de peso. A Sibutramina foi mais efetiva na redução da glicemia do que os grupos controle e Rimonabanto.

[Research ethics and the use of placebo: status of the debate in Canada].

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Keating, Bernard

2004-01-01

The question of the use of the placebo is one of the most controversial in the field of the ethics of research today. The use of the placebo remains the standard practice of biomedical research in spite of the fact that various revisions of the Helsinki Declaration have sought to limit its use. In Canada, the Tri-council policy statement: Ethical conduct for research involving humans adopted a very restrictive position with respect to the use of placebos, precisely defining the situations in which its use would meet the demands of ethical research. The positions taken by the various ethical decision-making bodies are, however, hardly shared by regulatory bodies such as the Food and drug administration (FDA), the Council for international organization of medical sciences (CIOMS) or the European agency for the evaluation of medicinal products (EMEA). This divergence of opinions reveals two quite different conceptions of what constitutes the ethical. In the case of decision-making bodies in the ethical field, it is clearly medicine's Hippocratic Oath which explains their reluctance to use placebos. The first responsibility of the doctor is to "do no harm" to his or her patient. This duty is inherent to the medical profession and as such is not grounded in the view of medicine as a contract for care. In the case of regulatory bodies, it is the vision of "medicine as contract" which is in view; and it is this notion that justifies the use of placebos once free and informed consent has been obtained. It is also worth noting that these regulatory bodies make frequent use of arguments based on utilitarian ends. In an unprecedented move, the World medical association published in October 2001 a clarification note about the use of placebos. An analysis of this text raises the question about its real meaning: clarification or concession?

Randomized, double-blind, placebo-controlled trial of herbal therapy for children with asthma.

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Wong, Eliza L Y; Sung, Rita Yn Tz; Leung, Ting Fan; Wong, Yeuk Oi; Li, Albert M C; Cheung, Kam Lau; Wong, Chun Kwok; Fok, Tai Fai; Leung, Ping Chung

2009-10-01

The purpose of this trial was to evaluate whether the herbal formula of CUF2 used as complementary therapy improves the clinical symptoms and biochemical markers in children with asthma using inhaled corticosteroids. In a double-blind, placebo-controlled prospective trial, 85 children with asthma aged 7-15 years were randomly assigned to receive either a daily oral herbal formula of 0.619-g CUF2 capsule of dried aqueous extract with an equal weight of five herbs (Astragalus mongholius Bunge, Cordyceps sinensis Sacc., Radix stemonae, Bulbus fritillariae cirrhosae, and Radix scutellariae) or placebo for 6 months. The primary endpoint was the change in steroids dosage; the secondary outcomes included the disease severity score, lung function test, and biochemical markers in blood. Eighty-five (85) children (42 on active treatment and 43 on placebo) completed the 6-month clinical trial. Children randomized to the herbal formula of CUF2 and the placebo showed a similar improvement in clinical symptoms and biomedical markers. The comparison between the CUF2 group and the placebo group showed no significant difference on the dosage of steroids (-2.3 versus -3.1 mg, p = 0.915), disease severity score (-2.3 versus -3.1, p = 0.215), and lung function test of forced expiratory volume in 1 second/forced vital capacity percent (0.1 versus 0.6%, p = 0.809) and peak expiratory flow rate (-7.3 versus -0.6 l/minutes, p = 0.118). No significant difference was found between the two study groups in the biochemical outcomes measured. The intervention effect of CUF2 was smaller than the placebo effect. This study provides no evidence to support the use of the herbal formula of CUF2 in children with asthma. Parents are thus advised to discuss with health professionals before choosing an herbal formula in preference to conventional treatment modes.

Distal Ureteric Stones and Tamsulosin: A Double-Blind, Placebo-Controlled, Randomized, Multicenter Trial.

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Furyk, Jeremy S; Chu, Kevin; Banks, Colin; Greenslade, Jaimi; Keijzers, Gerben; Thom, Ogilvie; Torpie, Tom; Dux, Carl; Narula, Rajan

2016-01-01

We assess the efficacy and safety of tamsulosin compared with placebo as medical expulsive therapy in patients with distal ureteric stones less than or equal to 10 mm in diameter. This was a randomized, double-blind, placebo-controlled, multicenter trial of adult participants with calculus on computed tomography (CT). Patients were allocated to 0.4 mg of tamsulosin or placebo daily for 28 days. The primary outcomes were stone expulsion on CT at 28 days and time to stone expulsion. There were 403 patients randomized, 81.4% were men, and the median age was 46 years. The median stone size was 4.0 mm in the tamsulosin group and 3.7 mm in the placebo group. Of 316 patients who received CT at 28 days, stone passage occurred in 140 of 161 (87.0%) in the tamsulosin group and 127 of 155 (81.9%) with placebo, a difference of 5.0% (95% confidence interval -3.0% to 13.0%). In a prespecified subgroup analysis of large stones (5 to 10 mm), 30 of 36 (83.3%) tamsulosin participants had stone passage compared with 25 of 41 (61.0%) with placebo, a difference of 22.4% (95% confidence interval 3.1% to 41.6%) and number needed to treat of 4.5. There was no difference in urologic interventions, time to self-reported stone passage, pain, or analgesia requirements. Adverse events were generally mild and did not differ between groups. We found no benefit overall of 0.4 mg of tamsulosin daily for patients with distal ureteric calculi less than or equal to 10 mm in terms of spontaneous passage, time to stone passage, pain, or analgesia requirements. In the subgroup with large stones (5 to 10 mm), tamsulosin did increase passage and should be considered. Copyright © 2015 American College of Emergency Physicians. Published by Elsevier Inc. All rights reserved.

State-dependent memory effects using caffeine and placebo do not extend to metamemory.

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Kelemen, William L; Creeley, Catherine E

2003-01-01

The authors examined the impact of caffeine on human memory and predictions of memory (i.e., metamemory). On Day 1, 83 college students drank a sweetened beverage containing either caffeine (4 mg/kg body weight) or a placebo before they studied 40 pairs of words. While the participants studied, they predicted their future memory performance for each word pair. On Day 2, the participants again received caffeine or a placebo before the memory test. The participants who drank the same beverage on both days (either caffeine or a placebo) recalled more word pairs than did those who drank different beverages (caffeine on 1 day and a placebo on the other day). In contrast, memory predictions were more accurate when the beverages did not match on both days. These data provide evidence for state-dependent memory when caffeine is used, but not for state-dependent metamemory. People's memory and their predictions of memory can be influenced in different ways if they drink caffeine before they study or take a test.

Síntesis de microcápsulas de poliurea a partir de aminas renovables, mediante doble emulsificación Synthesis of polyurea microcapsules from renewable amines by double emulsification

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Paula Mazo

2011-01-01

Full Text Available En este trabajo se realizó la microencapsulación de un perfume comercial mediante una doble emulsificación, la coraza de poliurea fue sintetizada por la reacción de Lisina con dos diisocianatos comerciales, uno aromático y otro alifático. En la síntesis se evaluó el efecto que tiene la relación molar amina:diisocianato y el tipo de emulsificante. Se optimizó el tamaño de partícula utilizando un diseño factorial 32 y análisis de superficie de respuesta, las variables fueron: cantidad de alcohol polivinílico y la relación de fase dispersa a fase continua. Las microcápsulas se caracterizaron mediante: análisis de calorimetría diferencial de barrido (DSC, espectroscopía infrarroja (IR, microscopía electrónica de barrido (SEM y tamaño medio de partícula. La doble emulsificación permite un mayor rendimiento de encapsulación del perfume, las micropartículas presentan un menor tamaño de partícula cuando: se emplea diisocianato aromático, un aumento de coloide protector (PVA y una disminución de la fase dispersa.This paper reports on the microencapsulation of a commercial perfume by means of a double emulsification, where the polyurea shell was synthesized by the reaction of lysine with two commercial di-isocyanates (aromatic and aliphatic. In the synthesis the factors evaluated were the amine:di-isocyanate molar ratio and the type of emulsifier. The particle size was optimized using a 3² factorial design and response surface analysis, with the following variables: amount of polyvinyl alcohol and the relationship of the disperse phase to continuous phase. The microcapsules were characterized using differential scanning calorimetry analysis (DSC, infrared spectroscopy (IR, scanning electron microscopy (SEM and mean particle size. The double emulsification allows for a greater yield in the encapsulation of perfume. Furthermore, the microparticles have a smaller particle size when the aromatic di-isocyanate was used, also

Farmacovigilancia de la sertralina en pacientes cubanos con episodio de depresión mayor Pharmaceutical surveillance of sertraline in Cuban patients affected by major depression episode

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Leslie Pérez Ruiz

2011-03-01

Full Text Available En la depresión predominan síntomas como: desinterés, fatiga, sentimientos de inutilidad, desconcentración, deseos de muerte e insomnio. Entre los medicamentos para tratarla se encuentra la sertralina. Con el objetivo de evaluar su seguridad, se revisaron 40 historias clínicas y cuadernos de recogida de datos de los pacientes incluidos en ensayo clínico fase III, aletatorizado, controlado y a doble ciegas: "Uso de sertralina en pacientes con episodio de depresión mayor", pertenecientes al Hospital "Dr. Gustavo Aldereguía Lima". Se obtuvieron datos demográficos, clínicos y eventos adversos, con los cuales se realizó un estudio descriptivo, observacional y transversal que clasifica como un estudio de utilización de medicamentos sobre consecuencias prácticas. La información fue analizada mediante SPSS, versión 13.0 para Windows. De los 40 pacientes incluidos, 24 presentaron eventos adversos para un 60 %; de ellos, 16 (67 % en el grupo tratado con sertralina y 8 (33 % en los tratados con placebo. Los eventos adversos más frecuentes fueron: disminución de peso, sequedad bucal, cefalea, diarreas y náuseas. En su mayoría resultaron de intensidad ligera, causalidad probable y sin necesidad de tratamiento. El uso del fármaco se consideró seguro en el tratamiento de estos pacientes.Some predominant symptoms in depression are lack of interest, fatigue, feeling of uselessness, lack of concentration, desire of being dead and insomnia. One of the drugs to treat this illness is Sertraline. For the purpose of evaluating its safety, 40 medical histories and data collection logs with information on patients included in a double-blind, controlled, randomized phase III clinical trial "Use of Sertraline in patients suffering episodes of great depression" were reviewed. These patients were seen at "Gustavo Aldereguía Lima" hospital. Demographic, clinical and adverse event data were obtained to undertake a descriptive, observational and cross

Placebo response in binge eating disorder: a pooled analysis of 10 clinical trials from one research group.

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Blom, Thomas J; Mingione, Carolyn J; Guerdjikova, Anna I; Keck, Paul E; Welge, Jeffrey A; McElroy, Susan L

2014-03-01

The aim of this study was to gain further understanding of placebo response in binge eating disorder. We pooled participant-level data from 10 double-blind, placebo-controlled, randomized trials of medications for binge eating disorder. The primary outcomes were response (75% reduction in binge eating episodes), cessation of binge eating episodes, change in mean weekly binge eating episodes and binge eating episodes per week. Of 234 participants receiving placebo, 89 (38%) were responders and 59 (26%) attained cessation. Placebo-treated participants significantly reduced their binge eating. The mean (SD) binge eating episodes per week at baseline was 5.2 (3.2) and at endpoint was 2.2 (2.6). Lower baseline binge eating episode frequency and longer study participation were significantly associated with response and cessation. Less severe eating pathology at baseline was associated with higher placebo response and cessation rates. Future clinical trials may want to stipulate that participants exceed a threshold of illness severity, which may lead to better placebo and drug separation. Copyright © 2014 John Wiley & Sons, Ltd and Eating Disorders Association.

Dialysis-associated hypertension treated with Telmisartan--DiaTel: a pilot, placebo-controlled, cross-over, randomized trial.

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Matthias Huber

Full Text Available Treatment of hypertension in hemodialysis (HD patients is characterised by lack of evidence for both the blood pressure (BP target goal and the recommended drug class to use. Telmisartan, an Angiotensin receptor blocker (ARB that is metabolised in the liver and not excreted via HD extracorporeal circuit might be particularly suitable for HD patients. We designed and conducted a randomised, placebo-controlled, double-blind and cross-over trial for treatment of dialysis-associated hypertension with telmisartan 80 mg once daily or placebo on top of standard antihypertensive treatment excluding other Renin-Angiotensin-System (RAS blockers. In 29 patients after randomization we analysed BP after a treatment period of 8 weeks, while 13 started with telmisartan and 16 with placebo; after 8 weeks 11 continued with telmisartan and 12 with placebo after cross-over, respectively. Patients exhibited a significant reduction of systolic pre-HD BP from 141.9±21.8 before to 131.3±17.3 mmHg after the first treatment period with telmisartan or placebo. However, no average significant influence of telmisartan was observed compared to placebo. The latter may be due to a large inter-individual variability of BP responses reaching from a 40 mmHg decrease under placebo to 40 mmHg increase under telmisartan. Antihypertensive co-medication was changed for clinical reasons in 7 out of 21 patients with no significant difference between telmisartan and placebo groups. Our starting hypothesis, that telmisartan on top of standard therapy lowers systolic office BP in HD patients could not be confirmed. In conclusion, this small trial indicates that testing antihypertensive drug efficacy in HD patients is challenging due to complicated standardization of concomitant medication and other confounding factors, e.g. volume status, salt load and neurohormonal activation, that influence BP control in HD patients.Clinicaltrialsregister.eu 2005-005021-60.

Efficacy of antidepressants for dysthymia: a meta-analysis of placebo-controlled randomized trials.

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Levkovitz, Yeciel; Tedeschini, Enrico; Papakostas, George I

2011-04-01

The authors sought to determine the efficacy of antidepressants in dysthymic disorder and to compare antidepressant and placebo response rates between major depressive disorder (MDD) and dysthymic disorder. PubMed/MEDLINE databases were searched for double-blind, randomized, placebo-controlled trials of antidepressants used as monotherapy for treatment of MDD or dysthymic disorder. We defined antidepressants as those with a letter of approval by the US, Canadian, or European Union drug regulatory agencies for treatment of MDD or dysthymic disorder, which included the following: amitriptyline, nortriptyline, imipramine, desipramine, clomipramine, trimipramine, protriptyline, dothiepin, doxepin, lofepramine, amoxapine, maprotiline, amineptine, nomifensine, bupropion, phenelzine, tranylcypromine, isocarboxazid, moclobemide, brofaromine, fluoxetine, sertraline, paroxetine, citalopram, escitalopram, fluvoxamine, zimelidine, tianeptine, ritanserin, trazodone, nefazodone, agomelatine, venlafaxine, desvenlafaxine, duloxetine, milnacipran, reboxetine, mirtazapine, and mianserin. Eligible studies were identified by cross-referencing the search term placebo with each of the above-mentioned agents. The search was limited to articles published between January 1, 1980, and November 20, 2009 (inclusive). To expand our database, we also reviewed the reference lists of the identified studies. We selected randomized, double-blind, placebo-controlled trials of antidepressants for either MDD or dysthymic disorder according to preset criteria relating to comorbidities, patient age, drug formulation, study duration, diagnostic criteria, choice of assessment scales, and whether or not the study reported original data. Final selection of articles was determined by consensus among the authors. A total of 194 studies were found that were eligible for inclusion in our analysis. Of these, 177 focused on the treatment of MDD and 17 on the treatment of dysthymic disorder. We found that

Sodium valproate in the treatment of aggressive behavior in patients with dementia--a randomized placebo controlled clinical trial

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Sival, Rob C.; Haffmans, P. M. Judith; Jansen, Paul A. F.; Duursma, Sijmen A.; Eikelenboom, Piet

2002-01-01

OBJECTIVES: The efficacy and tolerability of sodium valproate 2 x 240 mg compared to placebo were investigated in aggressive behavior in dementia. DESIGN: A randomized, placebo controlled, double-blind cross-over design. The trial included a baseline period (one week); a placebo period (three

Predictive factors for the placebo effect in clinical trials for dry eye: a pooled analysis of three clinical trials.

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Imanaka, Takahiro; Sato, Izumi; Tanaka, Shiro; Kawakami, Koji

2017-11-01

Placebo effect is one of the methodological difficulties in dry eye clinical trials. If we could elucidate the tendencies of the placebo response and find predictors, we could reduce the placebo response in clinical trials for dry eye. In this study, we investigated the predictive factors for the placebo effect in dry eye clinical trials. A total of 205 patients with dry eye assigned to the placebo arms of three placebo-controlled randomised clinical trials were analysed by simple and multivariable regression analysis. The corneal fluorescein (FL) staining score and dry eye symptoms were studied at week 4. The variables of interest included gender, age, complications of Sjögren's syndrome, Schirmer's test I value, tear break-up time and conjunctival hyperaemia score. We also conducted a stratified analysis according to the patients' age. Among all the studied endpoints, the baseline scores were significantly related to the corresponding placebo response. In addition, for the FL score and the dryness score, age was a significant predictor of the placebo response (p=0.04 and p<0.0001, respectively). Stratified analysis by age showed that patients more than 40 years of age are more likely to have a stronger placebo response in the FL and dryness scores. The baseline scores and age were predictive factors of the placebo response in frequently used endpoints, such as FL score or dryness symptoms. These patient characteristics can be controlled by study design, and our findings enable the design of more efficient placebo-controlled studies with good statistical power. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Reiki Is Better Than Placebo and Has Broad Potential as a Complementary Health Therapy

Science.gov (United States)

2017-01-01

This study reviews the available clinical studies of Reiki to determine whether there is evidence for Reiki providing more than just a placebo effect. The available English-language literature of Reiki was reviewed, specifically for peer-reviewed clinical studies with more than 20 participants in the Reiki treatment arm, controlling for a placebo effect. Of the 13 suitable studies, 8 demonstrated Reiki being more effective than placebo, 4 found no difference but had questionable statistical resolving power, and only one provided clear evidence for not providing benefit. Viewed collectively, these studies provide reasonably strong support for Reiki being more effective than placebo. From the information currently available, Reiki is a safe and gentle “complementary” therapy that activates the parasympathetic nervous system to heal body and mind. It has potential for broader use in management of chronic health conditions, and possibly in postoperative recovery. Research is needed to optimize the delivery of Reiki. PMID:28874060

Electric field-navigated transcranial magnetic stimulation for chronic tinnitus: a randomized, placebo-controlled study.

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Sahlsten, Hanna; Virtanen, Juuso; Joutsa, Juho; Niinivirta-Joutsa, Katri; Löyttyniemi, Eliisa; Johansson, Reijo; Paavola, Janika; Taiminen, Tero; Sjösten, Noora; Salonen, Jaakko; Holm, Anu; Rauhala, Esa; Jääskeläinen, Satu K

2017-09-01

Repetitive transcranial magnetic stimulation (rTMS) may alleviate tinnitus. We evaluated effects of electric field (E-field) navigated rTMS targeted according to tinnitus pitch. No controlled studies have investigated anatomically accurate E-field-rTMS for tinnitus. Effects of E-field-rTMS were evaluated in a prospective randomised placebo-controlled 6-month follow-up study on parallel groups. Patients received 10 sessions of 1 Hz rTMS or placebo targeted to the left auditory cortex corresponding to tonotopic representation of tinnitus pitch. Effects were evaluated immediately after treatment and at 1, 3 and 6 months. Primary outcome measures were visual analogue scores (VAS 0-100) for tinnitus intensity, annoyance and distress, and the Tinnitus Handicap Inventory (THI). Thirty-nine patients (mean age 50.3 years). The mean tinnitus intensity (F 3  = 15.7, p tinnitus, differences between active and placebo groups remained non-significant, due to large placebo-effect and wide inter-individual variation.

The effect of melatonin on sleep quality after laparoscopic cholecystectomy: a randomized, placebo-controlled trial

DEFF Research Database (Denmark)

Gögenur, Ismail; Kücükakin, Bülent; Bisgaard, Thue

2009-01-01

= 60) or placebo (n = 61) for 3 nights after surgery. Subjective sleep quality, sleep duration, sleep timing, and subjective discomfort (fatigue, general well-being, and pain) were measured. RESULTS: Sleep latency was significantly reduced in the melatonin group (mean [sd] 14 min [18]) compared...... with placebo (28 min [41]) on the first postoperative night (P = 0.015). The rest of the measured outcome variables did not differ between groups. CONCLUSIONS: Melatonin did not improve subjective sleep quality or discomfort compared with placebo after laparoscopic cholecystectomy....

Exposure of eyes to perfume: a double-blind, placebo-controlled experiment.

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Elberling, J; Duus Johansen, J; Dirksen, A; Mosbech, H

2006-08-01

Environmental perfume exposure can elicit bothersome respiratory symptoms. Symptoms are induced at exposure levels which most people find tolerable, and the mechanisms are unclear. The aim of the study was to investigate patients with eye and respiratory symptoms related to environmental perfume, by exposing the eyes to perfume in a double-blind, placebo-controlled study.Twenty-one eczema patients with respiratory symptoms elicited by perfume were compared with 21 healthy volunteers in a sex- and age-matched case-control study. The participants completed a symptom questionnaire, and underwent a double-blind, placebo-controlled exposure to perfume. Of the 42 individuals tested, 10 had more eye symptoms (irritation, itching, and tears) during perfume exposure than during placebo exposures, and eight of these individuals (P = 0.07, Fisher's exact test) belonged to the patient group. A true positive eye reaction to perfume was significantly associated with identification of perfume as an active exposure (P perfume elicited irritation in the eyes independently of olfaction, but the relative importance of ocular chemoperception in relation to elicitation of respiratory symptoms from common environmental exposures to perfume remains unclear. We investigated the hypothesis of an association between respiratory symptoms related to perfume and ocular perfume sensitivity by exposing the eyes to perfume in a double blind, placebo-controlled experiment. Vapors of perfume provoked symptoms in the relevant eye in some patients and healthy control persons, but under our exposure conditions, ocular chemesthesis failed to elicit respiratory symptoms.

Pregabalin and placebo responders show different effects on central pain processing in chronic pancreatitis patients

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Bouwense SA

2015-07-01

Full Text Available Stefan AW Bouwense,1 Søren S Olesen,2 Asbjørn M Drewes,2 Harry van Goor,1 Oliver HG Wilder-Smith31Pain and Nociception Neuroscience Research Group, Department of Surgery, Radboud university medical center, Nijmegen, The Netherlands; 2Mech-Sense, Department of Gastroenterology and Hepatology, Aalborg University Hospital, Aalborg, Denmark; 3Pain and Nociception Neuroscience Research Group, Department of Anaesthesiology, Pain and Palliative Medicine, Radboud university medical center, Nijmegen, The NetherlandsBackground: Pain control in chronic pancreatitis is a major challenge; the mechanisms behind analgesic treatment are poorly understood. This study aims to investigate the differences in pain sensitivity and modulation in chronic pancreatitis patients, based on their clinical response (responders vs nonresponders to placebo or pregabalin treatment. Methods: This study was part of a randomized, double-blind, placebo-controlled trial evaluating the analgesic effects of pregabalin and placebo in chronic pancreatitis. Post hoc, patients were assigned to one of four groups, ie, responders and nonresponders to pregabalin (n=16; n=15 or placebo (n=12; n=17 treatment. Responders were defined as patients with >30% pain reduction after 3 weeks of treatment. We measured change in pain sensitivity before and after the treatment using electric pain detection thresholds (ePDT in dermatomes C5 (generalized effects and Ventral T10 (segmental effects. Descending endogenous pain modulation was quantified via conditioned pain modulation (CPM paradigm. Results: Sixty patients were analyzed in a per-protocol analysis. ePDT change in C5 was significant vs baseline and greater in pregabalin (1.3 mA vs placebo responders (−0.1 mA; P=0.015. This was not so for ePDT in Ventral T10. CPM increased more in pregabalin (9% vs placebo responders (−17%; P<0.001. CPM changed significantly vs baseline only for pregabalin responders (P=0.006. Conclusion: This hypothesis

Hypnotizability and Placebo Analgesia in Waking and Hypnosis as Modulators of Auditory Startle Responses in Healthy Women: An ERP Study.

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De Pascalis, Vilfredo; Scacchia, Paolo

2016-01-01

We evaluated the influence of hypnotizability, pain expectation, placebo analgesia in waking and hypnosis on tonic pain relief. We also investigated how placebo analgesia affects somatic responses (eye blink) and N100 and P200 waves of event-related potentials (ERPs) elicited by auditory startle probes. Although expectation plays an important role in placebo and hypnotic analgesia, the neural mechanisms underlying these treatments are still poorly understood. We used the cold cup test (CCT) to induce tonic pain in 53 healthy women. Placebo analgesia was initially produced by manipulation, in which the intensity of pain induced by the CCT was surreptitiously reduced after the administration of a sham analgesic cream. Participants were then tested in waking and hypnosis under three treatments: (1) resting (Baseline); (2) CCT-alone (Pain); and (3) CCT plus placebo cream for pain relief (Placebo). For each painful treatment, we assessed pain and distress ratings, eye blink responses, N100 and P200 amplitudes. We used LORETA analysis of N100 and P200 waves, as elicited by auditory startle, to identify cortical regions sensitive to pain reduction through placebo and hypnotic analgesia. Higher pain expectation was associated with higher pain reductions. In highly hypnotizable participants placebo treatment produced significant reductions of pain and distress perception in both waking and hypnosis condition. P200 wave, during placebo analgesia, was larger in the frontal left hemisphere while placebo analgesia, during hypnosis, involved the activity of the left hemisphere including the occipital region. These findings demonstrate that hypnosis and placebo analgesia are different processes of top-down regulation. Pain reduction was associated with larger EMG startle amplitudes, N100 and P200 responses, and enhanced activity within the frontal, parietal, and anterior and posterior cingulate gyres. LORETA results showed that placebo analgesia modulated pain-responsive areas

Buprenorphine Implants for Treatment of Opioid Dependence: Randomized Comparison to Placebo and Sublingual Buprenorphine/Naloxone

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Rosenthal, Richard N.; Ling, Walter; Casadonte, Paul; Vocci, Frank; Bailey, Genie L.; Kampman, Kyle; Patkar, Ashwin; Chavoustie, Steven; Blasey, Christine; Sigmon, Stacey; Beebe, Katherine L.

2015-01-01

Aims To evaluate safety and efficacy of buprenorphine implants (BI) versus placebo implants (PI) for the treatment of opioid dependence. A secondary aim compared BI to open-label sublingual buprenorphine/naloxone tablets (BNX). Design Randomized, double-blind, placebo-controlled trial. Subjects received either 4 buprenorphine implants (80 mg/implant) (n=114), 4 placebo implants (n=54), or open-label BNX (12–16 mg/d) (n=119). Setting 20 addiction treatment centers. Participants Adult outpatients (ages 18 to 65) with DSM-IV-TR opioid dependence. Measurements The primary efficacy endpoint was the percent of urine samples negative for opioids collected from weeks 1 to 24, examined as a cumulative distribution function (CDF). Findings The BI CDF was significantly different from placebo (P<.0001). Mean (95% CI) proportions of urines negative for opioids were: BI: 31.2% (25.3, 37.1) and PI: 13.4% (8.3, 18.6). BI subjects had a higher study completion rate relative to placebo (64% vs. 26%, P<.0001), lower clinician-rated (P<.0001) and patient-rated (P<.0001) withdrawal, lower patient-ratings of craving (P<.0001), and better subjects’ (P=.031) and clinicians’ (P=.022) global ratings of improvement. BI also resulted in significantly lower cocaine use (P=.0016). Minor implant-site reactions were comparable in the buprenorphine (27.2% [31/114]) and placebo groups (25.9% [14/54]). BI were non-inferior to BNX on percent urines negative for opioids [mean (95% CI): 33.5 (27.3, 39.6); CI for the difference of proportions, (−10.7, 6.2)]. Conclusions Compared with placebo, buprenorphine implants result in significantly less frequent opioid use, and are non-inferior to sublingual buprenorphine/naloxone tablets. PMID:23919595

A randomized placebo-controlled phase III trial of oral laquinimod for multiple sclerosis

DEFF Research Database (Denmark)

Vollmer, T L; Sorensen, P S; Selmaj, K

2014-01-01

The phase III placebo-controlled BRAVO study assessed laquinimod effects in patients with relapsing-remitting MS (RRMS), and descriptively compared laquinimod with interferon beta (IFNβ)-1a (Avonex(®) reference arm). RRMS patients age 18-55 years with Expanded Disability Status Scale (EDSS) scores...... months. The primary endpoint was annualized relapse rate (ARR); secondary endpoints included percent brain volume change (PBVC) and 3-month confirmed disability worsening. In all, 1,331 patients were randomized: laquinimod (n = 434), placebo (n = 450), and IFNβ-1a (n = 447). ARR was not significantly...... reduced with laquinimod [-18 %, risk ratio (RR) = 0.82, 95 % CI 0.66-1.02; p = 0.075] vs. placebo. Laquinimod significantly reduced PBVC (28 %, p change in confirmed disability worsening with laquinimod measured...

Efficacy of atomoxetine in adult attention-Deficit/Hyperactivity Disorder: a drug-placebo response curve analysis

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Reimherr Fred

2005-10-01

Full Text Available Abstract Background The objective of this study was to evaluate the efficacy of atomoxetine, a new and highly selective inhibitor of the norepinephrine transporter, in reducing symptoms of attention-deficit/hyperactivity disorder (ADHD among adults by using drug-placebo response curve methods. Methods We analyzed data from two double-blind, placebo-controlled, parallel design studies of adult patients (Study I, N = 280; Study II, N = 256 with DSM-IV-defined ADHD who were recruited by referral and advertising. Subjects were randomized to 10 weeks of treatment with atomoxetine or placebo, and were assessed with the Conners Adult ADHD Rating Scales and the Clinical Global Impression of ADHD Severity scale before and after treatment. Results Those treated with atomoxetine were more likely to show a reduction in ADHD symptoms than those receiving placebo. Across all measures, the likelihood that an atomoxetine-treated subject improved to a greater extent than a placebo-treated subject was approximately 0.60. Furthermore, atomoxetine prevented worsening of most symptom classes. Conclusion From these findings, we conclude that atomoxetine is an effective treatment for ADHD among adults when evaluated using several criteria.

Double-blind, placebo-controlled study of dialectical behavior therapy plus olanzapine for borderline personality disorder.

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Soler, Joaquim; Pascual, Juan Carlos; Campins, Josefa; Barrachina, Judith; Puigdemont, Dolors; Alvarez, Enrique; Pérez, Victor

2005-06-01

The aim of this study was to determine the efficacy and safety of dialectical behavior therapy plus olanzapine compared with dialectical behavior therapy plus placebo in patients with borderline personality disorder. Sixty patients with borderline personality disorder were included in a 12-week, double-blind, placebo-controlled study. All patients received dialectical behavior therapy and were randomly assigned to receive either olanzapine or placebo following a 1-month baseline period. Seventy percent of the patients completed the 4-month trial. Combined treatment showed an overall improvement in most symptoms studied in both groups. Olanzapine was associated with a statistically significant improvement over placebo in depression, anxiety, and impulsivity/aggressive behavior. The mean dose of olanzapine was 8.83 mg/day. A combined psychotherapeutic plus pharmacological approach appears to lower dropout rates and constitutes an effective treatment for borderline personality disorder.

Placebo response and remission rates in randomised trials of induction andmaintenance therapy for ulcerative colitis

NARCIS (Netherlands)

Jairath, Vipul; Zou, G. Y.; Parker, Claire E.; Macdonald, John K.; AlAmeel, Turki; Al Beshir, Mohammad; Almadi, Majid A.; Al-Taweel, Talal; Atkinson, Nathan S. S.; Biswas, Sujata; Chapman, Thomas; Dulai, Parambir S.; Glaire, Mark A.; Hoekman, Daniel R.; Koutsoumpas, Andreas; Minas, Elizabeth; Mosli, Mahmoud H.; Samaan, Mark; Khanna, Reena; Travis, Simon; D'Haens, Geert; Sandborn, William J.; Feagan, Brian G.

2017-01-01

Background It is important to minimize placebo rates in randomised controlled trials (RCTs) to efficiently detect treatment differences between interventions. Historically, high placebo rates have been observed in clinical trials of ulcerative colitis (UC). A better understanding of factors

The treatment of severe premenstrual syndrome with goserelin with and without 'add-back' estrogen therapy: a placebo-controlled study.

Science.gov (United States)

Leather, A T; Studd, J W; Watson, N R; Holland, E F

1999-02-01

The study aimed to determine if the addition of daily low-dose oral estrogen with a cyclical progestogen given to young women using a depot gonadotropin-releasing hormone (GnRH) analog implant for the treatment of their premenstrual syndrome (PMS) would affect the clinical outcome. In a double-blind placebo-controlled study in a specialist premenstrual syndrome clinic setting, 60 women aged between 20 and 45 years were randomized to one of three treatment groups: Group A (placebo implant four weekly + placebo tablets daily), Group B (goserelin 3.6 mg implant four weekly + estradiol valerate 2 mg daily with norethisterone 5 mg from days 21-28 of a 28-day cycle) or Group C (goserelin 3.6 mg implant four weekly + placebo tablets daily). Differences between PMS scores at 2, 4 and 6 months were compared with pretreatment values. There was a significant improvement in PMS scores in Group C (Zoladex + placebo) after 2, 4 and 6 months of treatment when compared to pretreatment values and Group A (placebo + placebo). The addition of a low-dose oral estrogen with a cyclical progestogen to GnRH analog treatment (Group B) resulted in a less dramatic response when compared to pretreatment values and no significant improvement when compared to Group A (placebo + placebo) at 2, 4 and 6 months of treatment. The addition of a low-dose oral estrogen with a cyclical progestogen to depot GnRH analog therapy in the treatment of PMS reduces the clinical response.

Differential Effectiveness of Electromyograph Feedback, Verbal Relaxation Instructions, and Medication Placebo with Tension Headaches

Science.gov (United States)

Cox, Daniel J.; And Others

1975-01-01

Adults with chronic tension headaches were assigned to auditory electromyograph (EMG) feedback (N=9), to progressive relaxation (N=9), and to placebo treatment (N=9). Data indicated that biofeedback and verbal relaxation instructions were equally superior to the medicine placebo on all measured variables in the direction of clinical improvement,…

Topical sucralfate treatment of anal fistulotomy wounds: a randomized placebo-controlled trial.

Science.gov (United States)

Gupta, Pravin J; Heda, Purushottam S; Shrirao, Subhash A; Kalaskar, Surekha S

2011-06-01

Sucralfate is a cytoprotective agent which adheres to mucoproteins and forms a protective barrier at wound sites. In oral form it is a common ulcer medication, and as a topical preparation it has been used to treat a wide variety of wounds. The present study was designed to evaluate the effectiveness and safety of topical sucralfate in wound healing after anal fistulotomy. Double-blind, randomized controlled study comparing topical application of sucralfate or placebo. Private outpatient clinic specializing in anorectal disease in Nagpur, India. Patients with a wound length of at least 5 cm after low anal fistulotomy were eligible for the study. Patients were randomly assigned to receive ointment containing 7% sucralfate or a placebo ointment consisting of petroleum jelly. Patients were instructed to apply approximately 3 g of ointment to the wound twice daily after a sitz bath for 6 weeks or until the wound had healed. The wounds were examined by a blinded independent observer at 2, 4, and 6 weeks after the operation. The primary end point was the proportion of patients with wounds that had completely healed. Secondary end points included amount of mucosal covering (scored by the observer), adverse events, and postoperative pain (self-rated on a visual analog scale). Of 80 participants (29 women, 51 men; median age, 23 (range, 17-49) years), 76 participants completed the trial (sucralfate, 39; placebo, 37). At 6-week follow-up, complete wound healing was achieved in 37 patients (95%) in the sucralfate group and 27 patients (73%) in the placebo group (P = .009). Mucosal coverage of the wound was significantly greater with sucralfate than with placebo at each measurement point (P = .01). No adverse events were observed. Postoperative pain scores were significantly lower for sucralfate than for placebo at 2 and 4 weeks after the start of treatment. Wound tissue specimens were not available for morphological and ultrastructural analysis. The results of this study add

Primaquina y recurrencias de malaria por Plasmodium vivax. Metanálisis de estudios clínicos controlados

Directory of Open Access Journals (Sweden)

Jaime Carmona Fonseca

2015-03-01

Full Text Available ANTECEDENTES: La primaquina (PQ se usa contra recurrencias del paludismo vivax (RPV, pero se desconocen varios aspectos posológicos, como la dosis total (DT eficaz en determinado número de días. OBJETIVO: Comparar regímenes de PQ contra RPV en estudios clínicos controlados (ECC aleatorios o no aleatorios. METODOLOGÍA: Metanálisis. Se buscó información hasta el 31 de diciembre de 2012 en Lilacs, SciELO, PubMed (Medline, Cochrane Library, Cochrane Infectious Diseases Group, Embase. Se usaron estudios experimentales o ECC, siempre con grupo control concurrente. Se incluyeron estudios con o sin asignación aleatoria, "close label" o "open label", con tratamiento supervisado o no supervisado No se exigió que el estudio estableciera diferencia entre recaída y reinfección mediante pruebas moleculares. Se aplicaron criterios de inclusión y exclusión a los artículos y satisfacer los de inclusión constituyó calidad adecuada para dejarlos en el metanálisis. RESULTADOS: Se completaron 23 ECC, que reunieron los criterios de selección. Evaluamos 4 esquemas de dosis total (DT dada en determinados días (DT mg número de días: 210 14 = 210 mg en 14 días; 210 7 = 210 mg en 7 días; 45 a 150 mg en 3 a 10 días; 0 (no PQ. La ausencia de PQ llevó a la recurrencia de 34,48% frente a 19,66% con PQ 210 14 (diferencia significativa; 210 14 mostró eficacia igual a la de 210 7. Cada esquema 210 7 y 210 14 es mejor estadísticamente que 45 a 150. CONCLUSIONES: El uso de PQ es necesario para reducir las recurrencias y la DT 210 mg dada en 7 ó en 14 días es la que mejor eficacia tiene pero se requieren más estudios con el esquema 210 7.

Placebo cessation in binge eating disorder: effect on anthropometric, cardiovascular, and metabolic variables.

Science.gov (United States)

Blom, Thomas J; Guerdjikova, Anna I; Mori, Nicole; Casuto, Leah S; McElroy, Susan L

2015-01-01

The aim of this study was to evaluate the effects of cessation of binge eating in response to placebo treatment in binge eating disorder (BED) on anthropometric, cardiovascular, and metabolic variables. We pooled participant-level data from 10 randomized, double-blind, placebo-controlled trials of medication for BED. We then compared patients who stopped binge eating with those who did not on changes in weight, body mass index (BMI), systolic and diastolic blood pressure, pulse, and fasting lipids and glucose. Of 234 participants receiving placebo, 60 (26%) attained cessation from binge eating. Patients attaining cessation showed modestly decreased diastolic blood pressure compared with patients who continued to binge eat. Weight and BMI remained stable in patients who stopped binge eating, but increased somewhat in those who continued to binge eat. Patients who stopped binge eating with placebo had greater reductions in diastolic blood pressure and gained less weight than patients who continued to binge eat. Self-report of eating pathology in BED may predict physiologic variables. Copyright © 2014 John Wiley & Sons, Ltd and Eating Disorders Association. Copyright © 2014 John Wiley & Sons, Ltd and Eating Disorders Association.

Le placebo a-t-il sa place dans la relation soignant–soigné à l’hôpital ?

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Tacheau , M.; Reny , J.; Crépin , E.; Akhdari , M.; Héron , Anne

2017-01-01

International audience; Some complaints and some diseases lead caregivers to use placebos. What is the caregiver’s intention in this case? Is placebo compatible with the confidence inherent to the relationship between medical team and patient? Could it be considered as a “benevolent lie”? Would it be confusion between placebo and placebo effect? Social and medical representations of care are impregnated with the culture of action. Pharmacological treatment is currently the preponderant respon...

You Can't Always Get What You Want: The Influence of Choice on Nocebo and Placebo Responding.

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Bartley, Hannah; Faasse, Kate; Horne, Rob; Petrie, Keith J

2016-06-01

Choice may be an important influence on the effectiveness and side effects of medical treatments. We investigated the impact of having a choice of medication compared to no choice on both nocebo and placebo responding. Sixty-one participants were randomly assigned to either choose between or be assigned to one of the two equivalent beta-blocker medications (actually placebos) for pre-examination anxiety. There was a greater nocebo response in the no choice group and an increased placebo response in the choice group. Participants in the no choice group attributed significantly more side effects to the tablet than the choice group (p = 0.045), particularly at the 24-h follow-up (p = 0.002). The choice group showed a stronger placebo response in heart rate than the non-choice group. Not being given a choice of medication increased the nocebo effect and reduced the placebo response to the treatment.

Inorganic Nitrate in Angina Study: A Randomized Double-Blind Placebo-Controlled Trial.

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Schwarz, Konstantin; Singh, Satnam; Parasuraman, Satish K; Rudd, Amelia; Shepstone, Lee; Feelisch, Martin; Minnion, Magdalena; Ahmad, Shakil; Madhani, Melanie; Horowitz, John; Dawson, Dana K; Frenneaux, Michael P

2017-09-08

In this double-blind randomized placebo-controlled crossover trial, we investigated whether oral sodium nitrate, when added to existing background medication, reduces exertional ischemia in patients with angina. Seventy patients with stable angina, positive electrocardiogram treadmill test, and either angiographic or functional test evidence of significant ischemic heart disease were randomized to receive oral treatment with either placebo or sodium nitrate (600 mg; 7 mmol) for 7 to 10 days, followed by a 2-week washout period before crossing over to the other treatment (n=34 placebo-nitrate, n=36 nitrate-placebo). At baseline and at the end of each treatment, patients underwent modified Bruce electrocardiogram treadmill test, modified Seattle Questionnaire, and subgroups were investigated with dobutamine stress, echocardiogram, and blood tests. The primary outcome was time to 1 mm ST depression on electrocardiogram treadmill test. Compared with placebo, inorganic nitrate treatment tended to increase the primary outcome exercise time to 1 mm ST segment depression (645.6 [603.1, 688.0] seconds versus 661.2 [6183, 704.0] seconds, P =0.10) and significantly increased total exercise time (744.4 [702.4, 786.4] seconds versus 760.9 [719.5, 802.2] seconds, P =0.04; mean [95% confidence interval]). Nitrate treatment robustly increased plasma nitrate (18.3 [15.2, 21.5] versus 297.6 [218.4, 376.8] μmol/L, P nitrate treatment). Other secondary outcomes were not significantly altered by the intervention. Patients on antacid medication appeared to benefit less from nitrate supplementation. Sodium nitrate treatment may confer a modest exercise capacity benefit in patients with chronic angina who are taking other background medication. URL: https://www.clinicaltrials.gov/. Unique identifier: NCT02078921. EudraCT number: 2012-000196-17. © 2017 The Authors. Published on behalf of the American Heart Association, Inc., by Wiley.

General lack of use of placebo in prophylactic, randomised, controlled trials in adult migraine. A systematic review

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Hougaard, Anders; Tfelt-Hansen, Peer

2016-01-01

of placebo control in such trials has not been systematically assessed. METHODS: We performed a systematic review of all comparative RCTs of prophylactic drug treatment of migraine published in English from 2002 to 2014. PubMed was searched using the Cochrane Highly Sensitive Search Strategy for identifying...... reports of RCTs. RESULTS: A placebo arm was used in requiring more than 75,000 patient days, no difference...... was identified across treatment arms and conclusions regarding drug superiority could not be drawn. CONCLUSIONS: The majority of comparative, prophylactic migraine RCTs do not include a placebo arm. Failure to include a placebo arm may result in failure to demonstrate efficacy of potentially effective migraine...

Opioid abusers’ ability to differentiate an opioid from placebo in laboratory challenge testing*

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Antoine, Denis G.; Strain, Eric C.; Tompkins, D. Andrew; Bigelow, George E.

2013-01-01

Background Abuse liability assessments influence drug development, federal regulation, and clinical care. One suggested procedure to reduce variability of assessments is a qualification phase, which assesses whether study applicants adequately distinguish active drug from placebo; applicants failing to make this distinction are disqualified. The present analyses assessed differences between qualification phase qualifiers and non-qualifiers. Methods Data were collected from 23 completers of the qualification phase of an abuse liability study. Opioid abusing participants received 30 mg oxycodone and placebo orally on separate days, and were characterized as qualifiers (vs. non-qualifiers) if their peak visual analog scale liking rating for oxycodone was at least 20 points higher than placebo’s peak rating. Groups were compared on demographic characteristics, drug history, and physiologic, subject and observer ratings. Results 61% of participants were qualifiers and 39% were non-qualifiers. Groups had similar demographic characteristics, drug use histories, and pupillary constriction responses. However, unlike qualifiers, non-qualifiers had an exaggerated placebo response for the liking score (p=0.03) and an attenuated oxycodone response for the liking score (p<.0001). Non-qualifiers’ failure to differentiate oxycodone versus placebo was evident for subject and observer ratings. Conclusion Different subjective responses to identical stimuli support the use of a qualification phase in abuse liability assessments. Further research should explore objective measures that may better account for these differences, determine optimal qualification criteria, and explore the developmental course of drug use. This study also documents certain opioid abusers fail to differentiate 30 mg of oxycodone from placebo, a phenomenon deserving further study. PMID:23369645

Placebo HAART Regimen as a Method for Teaching Medication Adherence Issues to Students

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Sutton, Eliza L; Transue, Emily R; Comes E, Susan; Paauw, Douglas S

2005-01-01

Placebo medication regimens may help educate students about adherence issues. In this randomized trial, 23 third-year medical students took a 2-week placebo regimen mimicking highly active antiretroviral therapy (HAART) during their medicine clerkship; 15 students served as controls. Although no effect was demonstrated from this intervention on an evaluation instrument examining attitudes and beliefs about medication nonadherence, all 23 student-subjects agreed in postintervention interviews ...

Prevalence of lactose intolerance in Chile: a double-blind placebo study.

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Latorre, Gonzalo; Besa, Pablo; Parodi, Carmen G; Ferrer, Verónica; Azocar, Lorena; Quirola, Marife; Villarroel, Luis; Miquel, Juan F; Agosin, Eduardo; Chianale, José

2014-01-01

Lactase non-persistence (LNP), or primary hypolactasia, is a genetic condition that mediates lactose malabsorption and can cause lactose intolerance. Here we report the prevalence of lactose intolerance in a double-blind placebo study. The LCT C>T-13910 variant was genotyped by RT-PCR in 121 volunteers and lactose malabsorption was assessed using the hydrogen breath test (HBT) after consuming 25 g of lactose. Lactose intolerance was assessed by scoring symptoms (SS) using a standardized questionnaire following challenge with a lactose solution or saccharose placebo. The LNP genotype was observed in 57% of the volunteers, among whom 87% were HBT⁺. In the HBT⁺ group the median SS was 9 and in the HBT⁻ group the median SS was 3 (p lactose intolerance was defined as the presence of an SS ≥ 6 points after subtracting the placebo effect and 34% of the study population met this definition. The LNP genotype was present in more than half of subjects evaluated and the observed prevalence of lactose intolerance was 34%. © 2014 S. Karger AG, Basel.

Placebo response of non-pharmacological and pharmacological trials in major depression: a systematic review and meta-analysis.

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André Russowsky Brunoni

Full Text Available BACKGROUND: Although meta-analyses have shown that placebo responses are large in Major Depressive Disorder (MDD trials; the placebo response of devices such as repetitive transcranial magnetic stimulation (rTMS has not been systematically assessed. We proposed to assess placebo responses in two categories of MDD trials: pharmacological (antidepressant drugs and non-pharmacological (device- rTMS trials. METHODOLOGY/PRINCIPAL FINDINGS: We performed a systematic review and meta-analysis of the literature from April 2002 to April 2008, searching MEDLINE, Cochrane, Scielo and CRISP electronic databases and reference lists from retrieved studies and conference abstracts. We used the keywords placebo and depression and escitalopram for pharmacological studies; and transcranial magnetic stimulation and depression and sham for non-pharmacological studies. All randomized, double-blinded, placebo-controlled, parallel articles on major depressive disorder were included. Forty-one studies met our inclusion criteria - 29 in the rTMS arm and 12 in the escitalopram arm. We extracted the mean and standard values of depression scores in the placebo group of each study. Then, we calculated the pooled effect size for escitalopram and rTMS arm separately, using Cohen's d as the measure of effect size. We found that placebo response are large for both escitalopram (Cohen's d - random-effects model - 1.48; 95%C.I. 1.26 to 1.6 and rTMS studies (0.82; 95%C.I. 0.63 to 1. Exploratory analyses show that sham response is associated with refractoriness and with the use of rTMS as an add-on therapy, but not with age, gender and sham method utilized. CONCLUSIONS/SIGNIFICANCE: We confirmed that placebo response in MDD is large regardless of the intervention and is associated with depression refractoriness and treatment combination (add-on rTMS studies. The magnitude of the placebo response seems to be related with study population and study design rather than the intervention

Safety of polyethylene glycol 3350 solution in chronic constipation: randomized, placebo-controlled trial.

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McGraw, Thomas

2016-01-01

To evaluate the safety and tolerability of aqueous solution concentrate (ASC) of polyethylene glycol (PEG) 3350 in patients with functional constipation. The patients who met Rome III diagnostic criteria for functional constipation were randomized in this multicenter, randomized, placebo-controlled, single-blind study to receive once daily dose of PEG 3350 (17 g) ASC or placebo solution for 14 days. The study comprised a screening period (visit 1), endoscopy procedure (visits 2 and 3), and followup telephone calls 30 days post-treatment. Safety end points included adverse events (AEs), clinical laboratory evaluations, vital signs, and others. The primary end points were the proportion of patients with abnormalities of the oral and esophageal mucosa, detected by visual and endoscopic examination of the oral cavity and esophagus, respectively, compared with placebo. A secondary objective was to compare the safety and tolerability of ASC by evaluating AEs or adverse drug reactions. A total of 65 patients were enrolled in this study, 31 were randomized to PEG 3350 ASC and 34 were randomized to placebo, of which 62 patients completed the study. No patients in either group showed abnormalities in inflammation of the oral mucosa during visit 2 (before treatment) or visit 3 (after treatment). Fewer abnormalities of the esophageal mucosa were observed in the PEG 3350 ASC group than in the placebo group on visit 3, with no significant difference in the proportion of abnormalities between the treatment groups. Overall, 40 treatment-emergent AEs were observed in 48.4% of patients treated with PEG 3350 ASC, and 41 treatment-emergent AEs were observed in 55.9% of patients treated with placebo - nonsignificant difference of -7.5% (95% CI: -21.3, 6.3) between treatment groups. No serious AEs or deaths were reported, and no patient discontinued because of an AE. PEG 3350 ASC is safe and well tolerated in patients with functional constipation (NCT01885104).

Randomized, double-blind, placebo-controlled trial of saw palmetto in men with lower urinary tract symptoms.

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Gerber, G S; Kuznetsov, D; Johnson, B C; Burstein, J D

2001-12-01

To assess the effects of saw palmetto on urinary symptoms, sexual function, and urinary flow rate in men with lower urinary tract symptoms using a double-blind, randomized, placebo-controlled trial. The eligible patients were 45 years of age or older and had an International Prostate Symptom Score of 8 or greater. After a 1-month placebo run-in period, 85 men were randomized to receive saw palmetto or placebo for 6 months. Patients were evaluated using the International Prostate Symptom Score, a sexual function questionnaire, and by measurement of the urinary flow rate. The mean symptom score decreased from 16.7 to 12.3 in the saw palmetto group compared with 15.8 to 13.6 in the placebo group (P = 0.038). The quality-of-life score improved to a greater degree in the saw palmetto group, but this difference was not statistically significant. No change occurred in the sexual function questionnaire results in either group. The peak flow rate increased by 1.0 mL/s and 1.4 mL/s in the saw palmetto and placebo groups, respectively (P = 0.73). Saw palmetto led to a statistically significant improvement in urinary symptoms in men with lower urinary tract symptoms compared with placebo. Saw palmetto had no measurable effect on the urinary flow rates. The mechanism by which saw palmetto improves urinary symptoms remains unknown.

The effect of Neuragen PN® on Neuropathic pain: A randomized, double blind, placebo controlled clinical trial

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Li Li

2010-05-01

Full Text Available Abstract Background A double blind, randomized, placebo controlled study to evaluate the safety and efficacy of the naturally derived topical oil, "Neuragen PN®" for the treatment of neuropathic pain. Methods Sixty participants with plantar cutaneous (foot sole pain due to all cause peripheral neuropathy were recruited from the community. Each subject was randomly assigned to receive one of two treatments (Neuragen PN® or placebo per week in a crossover design. The primary outcome measure was acute spontaneous pain level as reported on a visual analog scale. Results There was an overall pain reduction for both treatments from pre to post application. As compared to the placebo, Neuragen PN® led to significantly (p ® reported pain reduction within 30 minutes. This reduction within 30 minutes occurred in only twenty one of sixty (35.0% subjects receiving the placebo. In a break out analysis of the diabetic only subgroup, 94% of subjects in the Neuragen PN® group achieved pain reduction within 30 minutes vs 11.0% of the placebo group. No adverse events were observed. Conclusions This randomized, placebo controlled, clinical trial with crossover design revealed that the naturally derived oil, Neuragen PN®, provided significant relief from neuropathic pain in an all cause neuropathy group. Participants with diabetes within this group experienced similar pain relief. Trial registration ISRCTN registered: ISRCTN13226601

COMPARACIÓN MEDIANTE UN ESTUDIO PROSPECTIVO Y ALEATORIZADO DE DOS MÉTODOS DE REPOSICIÓN EN UNIDADES DE ENFERMERÍA EN HOSPITALIZACIÓN POLIVALENTE DE AGUDOS CON ALMACENAMIENTO MEDIANTE DOBLE CAJETÍN

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José Luis Bernal

2017-01-01

Full Text Available Fundamentos: Los sistemas de almacenamiento mediante doble ca - jetín aumentan la satisfacción del personal de enfermería y disminuyen los inventarios, pero no se conocen las implicaciones de que sea el personal de logística quién determine la necesidad de reposición. El objetivo de este estudio fue evaluar si encomendar dicha responsabilidad a este personal en unidades de hospitalización polivalente de agudos entraña un mayor riesgo de pedidos extraordinarios. Métodos: Se realizó un estudio experimental, prospectivo aleatorizado con enmascaramiento. Los pedidos extraordinarios se consideraron variable de respuesta; los correspondientes a valoraciones del personal de logística se incluyeron en el grupo de intervención y los del personal de enfermería, en el de control. La concordancia entre observadores se analizó con el método de Bland- Altman; la diferencia entre grupos, con la U de Mann-Whitney y se calculó la incidencia acumulada de pedidos extraordinarios y su riesgo relativo. Resultados: La cantidad media solicitada por el personal de logística y el de enfermería fue 29,9 (DE:167,4 y 36 (DE:190 unidades respectiva - mente, la diferencia media entre observadores fue 6,11 (DE:128,95 uni - dades y no se encontraron diferencias significativas entre los grupos (p = 0,430. La incidencia de pedidos extraordinarios fue 0,64% en el grupo de intervención y 0,15% en el de control; el riesgo relativo, 2,31 (0,83 – 6,48 y el número de casos necesarios para un pedido extraordinario, 516. Conclusión: El riesgo de pedidos extraordinarios en unidades de hos - pitalización con almacenamiento mediante doble cajetín no está asociado con la categoría profesional del personal que identifica las necesidades de reposición.

A double-masked, placebo-controlled study of fluoxetine for hypochondriasis.

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Fallon, Brian A; Petkova, Eva; Skritskaya, Natalia; Sanchez-Lacay, Arturo; Schneier, Franklin; Vermes, Donna; Cheng, Jianfeng; Liebowitz, Michael R

2008-12-01

This study assessed the efficacy, durability, and tolerability of fluoxetine for hypochondriasis, a disorder for which controlled pharmacological trials are scarce. Fifty-seven patients with hypochondriasis were enrolled: 12 discontinued during the placebo run-in, and 45 were randomized to either fluoxetine or placebo for 12 weeks (acute treatment). Responder status was defined as a Clinical Global Impression rating for hypochondriasis of much or very much improved. Secondary outcome measures included severity of hypochondriasis, somatization, anxiety, and depression. Responders to acute treatment entered a 12-week maintenance phase to week 24. Sustained responders at week 24 entered a 12-week double-masked discontinuation phase. Primary analysis used the intent-to-treat sample. More patients responded with improvement in hypochondriasis when given fluoxetine compared with placebo, starting at week 8 (50.0% vs 19.0%, P = 0.03) and continuing to week 12 (62.5% vs 33.3%, P = 0.05). Mean dose at week 12 dose was 51.4 mg (SD, +/-23 mg). The acute treatment response was maintained to week 24 with more responders in the fluoxetine compared with the placebo group (54.2% vs 23.8%, P = 0.04). Significant improvement was not noted on the continuous secondary outcomes measures of hypochondriasis, with the exception of the Clinical Global Impression hypochondriasis severity scale at week 24. Likelihood of response was not associated with severity of psychiatric comorbidity. Durability of response after controlled drug discontinuation could not be reasonably assessed, given the small sample size of patients who entered the discontinuation phase (n = 10). Fluoxetine was well tolerated, with no significant differences in discontinuation due to side effects between treatment groups. Fluoxetine is a moderately effective and well-tolerated treatment for hypochondriasis.

Terlipressin versus placebo or no intervention for people with cirrhosis and hepatorenal syndrome

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Allegretti, Andrew S.; Israelsen, Mads; Krag, Aleksander

2017-01-01

) and abdominal pain (RR 1.54, 95% CI 0.97 to 2.43; 294 participants; low-quality evidence). We identified one ongoing trial on terlipressin versus placebo in participants with cirrhosis, ascites, and hepatorenal syndrome type 1. Three RCTs reported funding from a pharmaceutical company. The remaining trials did...... version of this systematic review found a potential beneficial effect of terlipressin on mortality and renal function in people with cirrhosis and hepatorenal syndrome. Objectives To assess the beneficial and harmful effects of terlipressin versus placebo/no intervention for people with cirrhosis...... until 21 November 2016. Selection criteria Randomised clinical trials (RCTs) involving participantswith cirrhosis and type 1 or type 2 hepatorenal syndrome allocated to terlipressin versus placebo or no intervention. We allowed co-administration with albumin administered to both comparison groups. Data...

Itopride in functional dyspepsia: results of two phase III multicentre, randomised, double-blind, placebo-controlled trials.

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Talley, N J; Tack, J; Ptak, T; Gupta, R; Giguère, M

2008-06-01

Functional dyspepsia (FD) is a common disorder but there is currently little efficacious drug therapy. Itopride, a prokinetic approved in several countries, showed promising efficacy in FD in a phase IIb trial. The aim of this study was to test the efficacy and safety of this drug in FD. Two similar placebo-controlled clinical trials were conducted (International and North America). Males and females, 18-65 years old, with a diagnosis of FD (Rome II) and the absence (by upper endoscopy) of any relevant structural disease were recruited. All were negative for Helicobacter pylori and, if present, heartburn could not exceed one episode per week. Following screening, patients were randomised to itopride 100 mg three times daily or identical placebo. The co-primary end points were: (1) global patient assessment (GPA) of efficacy; and (2) Leeds Dyspepsia Questionnaire (LDQ). Symptoms were evaluated at weeks 2, 4 and 8. Secondary measures of efficacy included Nepean Dyspepsia Index (NDI) quality of life. The GPA responder rates at week 8 on itopride versus placebo were similar in both trials (45.2% vs 45.6% and 37.8 vs 35.4%, respectively; p = NS). A significant benefit of itopride over placebo was observed for the LDQ responders in the International (62% vs 52.7%, p = 0.04) but not the North American trial (46.9% vs 44.8%). The safety and tolerability profile were comparable with placebo, with the exception of prolactin elevations, which occurred more frequently on itopride (18/579) than placebo (1/591). In this population with FD, itopride did not show a difference in symptom response from placebo.

Acute and long-term treatment of late-life major depressive disorder: duloxetine versus placebo.

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Robinson, Michael; Oakes, Tina Myers; Raskin, Joel; Liu, Peng; Shoemaker, Scarlett; Nelson, J Craig

2014-01-01

To compare the efficacy of duloxetine with placebo on depression in elderly patients with major depressive disorder. Multicenter, 24-week (12-week short-term and 12-week continuation), randomized, placebo-controlled, double-blind trial. United States, France, Mexico, Puerto Rico. Age 65 years or more with major depressive disorder diagnosis (one or more previous episode); Mini-Mental State Examination score ≥20; Montgomery-Asberg Depression Rating Scale total score ≥20. Duloxetine 60 or 120 mg/day or placebo; placebo rescue possible. Primary-Maier subscale of the 17-item Hamilton Depression Rating Scale (HAMD-17) at week 12. Secondary-Geriatric Depression Scale, HAMD-17 total score, cognitive measures, Brief Pain Inventory (BPI), Numeric Rating Scales (NRS) for pain, Clinical Global Impression-Severity scale, Patient Global Impression of Improvement in acute phase and acute plus continuation phase of treatment. Compared with placebo, duloxetine did not show significantly greater improvement from baseline on Maier subscale at 12 weeks, but did show significantly greater improvement at weeks 4, 8, 16, and 20. Similar patterns for Geriatric Depression Scale and Clinical Global Impression-Severity scale emerged, with significance also seen at week 24. There was a significant treatment effect for all BPI items and 4 of 6 NRS pain measures in the acute phase, most BPI items and half of the NRS measures in the continuation phase. More duloxetine-treated patients completed the study (63% versus 55%). A significantly higher percentage of duloxetine-treated patients versus placebo discontinued due to adverse event (15.3% versus 5.8%). Although the antidepressant efficacy of duloxetine was not confirmed by the primary outcome, several secondary measures at multiple time points suggested efficacy. Duloxetine had significant and meaningful beneficial effects on pain. Copyright © 2014 American Association for Geriatric Psychiatry. Published by Elsevier Inc. All rights

LA MECÁNICA DEL DOBLE SALTO MORTAL ATRÁS EN LA SALIDA DE PARALELAS ASIMÉTRICAS

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E. Laterza

2010-07-01

Full Text Available

Este artículo muestra un estudio biomecánico cinematográfico de la salida de doble mortal atrás agrupado en paralelas asimétricas por cuatro gimnastas durante el campeonato mundial celebrado en Sttugart en 1989. Los resultados muestran el instante del despegue, para todos los gimnastas; los instantes posteriores (unos 62 milisegundos de media y el instante en el que el centro de masas (CM alcanza su máxima velocidad de componente vertical (max. Vy. En los últimos 62 ms previos al despegue, mientras el CM recorría los últimos 14º de rotación sobre la banda superior, se observó una reducción de un 5% en la velocidad vertical del CM. A pesar de ello, durante ese corto período de tiempo el gimnasta obtenía, gracias al impulso de reacción vertical de la banda, un gran incremento de 0.15men la máxima altura obtenida por elCMdurante la fase de vuelo. Esto incrementa el importante rol que desempeñan las acciones ejecutadas en los instantes inmediatamente previos al despegue. Si el despegue hubiese ocurrido 62 ms antes, en el instante en que se obtiene la máxima Vy, el momento angular de los gimnastas podría haber sido superior, permitiendo una velocidad de rotación más elevada. Sin embargo, el ángulo de barrido en la fase aérea podría haber sido mayor y el tiempo de vuelo levemente menor (-1%.

La presencia de Max Weber en el pensamiento español. Historia de una doble recepción

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Ruano de la Fuente, María Yolanda

2007-08-01

Full Text Available This paper examines two diverse and confronted receptions of Max Weber’s thought in the Hispanic world which we have described as “conservative” and “liberal” lines of interpretation. This analytical scheme allows us to group and highlight some of the most distinguished Spanish intellectuals whose work was influenced by Max Weber’s thought. We will review the context and the particular mode in which these intellectuals assimilated the German author’s work, the meaning of their interpretations and their labour of translation. In short, we will focus on the works of some renowned Hispanic philosophers, jurists and sociologists belonging to the “first interpretative generation” at work from the 1920’s to the 1940’s.Este artículo examina una doble y contrapuesta línea de recepción del pensamiento de Max Weber en el mundo hispanoparlante, que hemos denominado línea “conservadora” y línea “liberal”. Este esquema interpretativo permite agrupar y reseñar a algunos de los más destacados intelectuales españoles, cuyas obras estuvieron marcadas por la influencia del pensamiento de Max Weber. Revisamos el contexto, el sentido de la recepción, la labor de traducción y el modo peculiar en que asimilaron el trabajo del autor alemán. Nos centramos, en suma, en la obra de algunos renombrados filósofos, juristas y sociólogos de habla hispana, si bien limitamos nuestro análisis a la “primera generación receptora”, que fechamos en las décadas de los años 20 a los 40 del siglo XX.

Evaluación del comportamiento hidráulico en un reactor anaerobio de doble cámara (RADCA

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Nancy Rincón

2011-01-01

tales como cortos circuitos, zonas muertas y recirculación interna afectan su desempeño. En esta investigación se evaluó el comportamiento hidráulico de un reactor anaerobio de doble cámara (RADCA de 534,5 L (cámara 1=305 L y cámara 2= 229,5 L como innovación tecnológica de los reactores UASB. El RADCA fue alimentado con agua residual municipal (ARM de la ciudad de Maracaibo, Venezuela; cada una de las cámaras fueron inoculadas con lodo granular (20% v/v proveniente de una cervecería local. La evaluación hidráulica se realizó en la fase líquida y en operación utilizando Li+ (LiCl como trazador aplicado de forma instantánea en el afluente a tiempo de retención hidráulico teórico (TRHt de 6 horas; 3,4 h en la cámara 1 y 2,6 para la cámara 2. El RADCA describió un flujo pistón en ambas cámaras y una eficiencia hidráulica cercana a la unidad (1 indicando una presencia casi nula de zonas muertas. La eficiencia de remoción de la DQO total (DQOT del RADCA se mantuvo en el rango de 59,77% a 74,64% con un promedio de 68,26%. Para las cámaras 1 y 2 la eficiencia promedio fue 60,4 y 20,94% con una producción de biogás (L/h de 2,768 y 0,541 respectivamente.

The power and value of placebo and nocebo in painful osteoarthritis.

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Dieppe, P; Goldingay, S; Greville-Harris, M

2016-11-01

This paper reviews some recent advances in our understanding of the effects of sham or dummy interventions on pain and other symptoms in osteoarthritis (OA), and outlines two new approaches to the investigation of placebo and nocebo effects. We argue that the placebo effect provides us with a valuable way of investigating the nature of conditions like OA. For example, by examining which symptoms, biochemical markers or imaging features do or do not respond to placebo, we might learn more about the relationships between pathology and symptoms in OA. Placebo and nocebo effects are positive or negative outcomes resulting from the human interactions and contexts in which healthcare consultations take place. Subtle changes in behaviours and the environments in which consultations take place can have major effects on pain and other symptoms being experienced by people with OA. Nocebo effects are particularly powerful, leading to many health-care professionals (HCPs) causing unintended harm to their clients. Based on our own research, we conclude that beneficial outcomes are most likely to occur when both the (HCP) and the client feel safe and relaxed, and when the experiences of the client are validated by the (HCP). These findings have important implications for clinical practice. We believe that research in this field needs to be 'trans-disciplinary', escaping from the constraints of the purely biomedical, deterministic, positivist paradigm of most medical research. We provide the example of our own work which combines performance studies and scholarship, with psychology and medicine. Copyright © 2016 Osteoarthritis Research Society International. Published by Elsevier Ltd. All rights reserved.

Disability and pain after cortisone versus placebo injection for trapeziometacarpal arthrosis and de Quervain syndrome

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Makarawung, Dennis J. S.; Becker, Stéphanie J. E.; Bekkers, Stijn; Ring, David

2013-01-01

This study tested the null hypothesis that type of injection (corticosteroid vs. placebo) is not a predictor of arm-specific disability as measured with the Disabilities of Arm, Shoulder and Hand questionnaire 1 to 3 months after injection of dexamethasone or placebo for treatment of

The Effect of Korean Red Ginseng on Sexual Function in Premenopausal Women: Placebo-Controlled, Double-Blind, Crossover Clinical Trial

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Ho Seok Chung

2015-01-01

Full Text Available This study investigated whether Korean red ginseng (KRG extracts could improve sexual function in premenopausal women. Forty-one premenopausal women participated in this placebo-controlled, double-blind, and crossover clinical study with administration of either three ginseng capsules (1 g per capsule or placebo daily. After 8 weeks of medication of KRG or placebo, medication was changed for the subjects to placebo or KRG after 2 weeks of washout period. The efficacy of KRG extracts was measured by using Female Sexual Function Index (FSFI. Results. Twenty-three women completed the study. Total FSFI scores increased after KRG treatment (from 20.13±2.87 to 23.98±4.10, p=0.015 and placebo treatment (from 20.06±2.64 to 23.78±3.28, p=0.003. However, this change was not significantly different between the two groups (p=0.702. KRG treatment significantly improved sexual desire, arousal, orgasm, and satisfaction domains; however, there was no treatment effect compared with placebo. There was a case of gastric discomfort after taking KRG extracts. Oral administration of KRG extracts improved sexual function in premenopausal women; however, there were no statistical significant changes compared to placebo. It implies that KRG extracts have a substantial placebo effect in premenopausal women with sexual dysfunction.

Dual renin-angiotensin system blockade plus oral methylprednisone for the treatment of proteinuria in IgA nephropathy Doble bloqueo del sistema renina-angiotensina más metilprednisona oral para el tratamiento de la proteinuria en la nefropatía por IgA

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Hernán Trimarchi

2007-10-01

Full Text Available Renin-angiotensin system inhibition is a widely accepted approach to initially deal with proteinuria in IgA nephropathy, while the role of immunosuppressants remains controversial in many instances. A prospective, uncontrolled, open-label trial was undertaken in patients with biopsy-proven IgA nephropathy with proteinuria > 0.5 g/day and normal renal function to assess the efficacy of a combination treatment of angiotensin converting enzyme inhibitors plus angiotensin receptor blockers enalapril valsartan coupled with methylprednisone to decrease proteinuria to levels below 0.5 g/day. Twenty patients were included: Age 37.45 ± 13.26 years (50% male; 7 patients (35% were hypertensive; proteinuria 2.2 ± 1.86 g/day; serum creatinine 1.07 ± 0.29 mg/dl; mean follow-up 60.10 ± 31.47 months. IgA nephropathy was subclassified according to Haas criteria. Twelve patients (60% were class II; seven (35% were class III and one (5% class V. All patients received dual reninangiotensin system blockade as tolerated. Oral methylprednisone was started at 0.5 mg/kg/day for the initial 8 weeks and subsequently tapered bi-weekly until the maintenance dose of 4 mg was reached. Oral steroids were discontinued after 24 weeks (6 months of therapy but renin-angiotensin inhibition remained unchanged. At 10 weeks of therapy proteinuria decreased to 0.15 ± 0.07 g/day (P El doble bloqueo del sistema renina-angiotensina con inhibidores de la enzima convertidora de angiotensina junto a bloqueadores del receptor tipo I de angiotensina II es aceptado como tratamiento en la proteinuria de la nefropatía por IgA, ya que el rol de los inmunosupresores continúa siendo controvertido. Estudio prospectivo, no controlado, abierto para pacientes con nefropatía por IgA con proteinurias >0.5 g/día y creatininas séricas <1.4 mg/dl, para evaluar la eficacia de tratamiento de enalapril más valsartán asociado a metilprednisona vía oral para disminuir las proteinurias a <0.5 g

Effect of lactic acid suppositories compared with oral metronidazole and placebo in bacterial vaginosis: a randomised clinical trial.

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Boeke, A J; Dekker, J H; van Eijk, J T; Kostense, P J; Bezemer, P D

1993-01-01

OBJECTIVE--To compare the effect of lactic acid locally, metronidazole orally and placebo in women with bacterial vaginosis. DESIGN--Randomised clinical trial. SETTING--30 general practices in the Netherlands. PATIENTS--125 women consulting the general practitioner for symptomatic bacterial vaginosis. MAIN OUTCOME MEASURES--Duration of subjective symptoms, recurrence of symptoms, clinically diagnosed cure, adverse events. RESULTS--Survival analysis showed a significantly faster disappearance of symptoms in the metronidazole category compared with both lactic acid and placebo (p = 0.0005 metronidazole v placebo, p = 0.0002 metronidazole v lactic acid p = 0.6521 lactic acid v placebo [The stratified Mantel Cox test]). The median duration until absence of symptoms was 21 days for metronidazole and 80 days for placebo. Disappearance of symptoms did not occur in 50% of the lactic acid group in 90 days. Recurrence rates of symptoms were similar over the treatment categories (p = 0.13 metronidazole v placebo and p = 0.12 lactic acid v placebo). After 2 weeks cure rates (cure defined as less than three of four clinical criteria present) were 83%, 49% and 47% for metronidazole, lactic acid and placebo category respectively. At that time cure rates (cure defined as none of three clinical criteria present) were 10%, 0% and 3%. After four weeks and three months these figures were: 55%, 20%, 20% and 64%, 28%, 28%. No differences in adverse events were found between the three interventions. CONCLUSIONS--Lactic acid suppositories are ineffective, metronidazole capsules are effective on signs and symptoms in bacterial vaginosis. A considerable proportion of the patients recover without active medication. PMID:8244360

Randomised, Double Blind, Placebo-Controlled Trial of Echinacea Supplementation in Air Travellers

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E. Tiralongo

2012-01-01

Full Text Available Objective. To identify whether a standardised Echinacea formulation is effective in the prevention of respiratory and other symptoms associated with long-haul flights. Methods. 175 adults participated in a randomised, double-blind placebo-controlled trial travelling back from Australia to America, Europe, or Africa for a period of 1–5 weeks on commercial flights via economy class. Participants took Echinacea (root extract, standardised to 4.4 mg alkylamides or placebo tablets. Participants were surveyed before, immediately after travel, and at 4 weeks after travel regarding upper respiratory symptoms and travel-related quality of life. Results. Respiratory symptoms for both groups increased significantly during travel (P<0.0005. However, the Echinacea group had borderline significantly lower respiratory symptom scores compared to placebo (P=0.05 during travel. Conclusions. Supplementation with standardised Echinacea tablets, if taken before and during travel, may have preventive effects against the development of respiratory symptoms during travel involving long-haul flights.

A 6 week randomized double-blind placebo-controlled trial of ziprasidone for the acute depressive mixed state.

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Ashwin Patkar

Full Text Available OBJECTIVE: To examine the efficacy of ziprasidone vs. placebo for the depressive mixed state in patients with bipolar disorder type II or major depressive disorder (MDD. METHODS: 73 patients were randomized in a double-blinded, placebo-controlled study to ziprasidone (40-160 mg/d or placebo for 6 weeks. They met DSM-IV criteria for a major depressive episode (MDE, while also meeting 2 or 3 (but not more nor less DSM-IV manic criteria. They did not meet DSM-IV criteria for a mixed or manic episode. Baseline psychotropic drugs were continued unchanged. The primary endpoint measured was Montgomery-Åsberg Depression Rating Scale (MADRS scores over time. The mean dose of ziprasidone was 129.7±45.3 mg/day and 126.1±47.1 mg/day for placebo. RESULTS: The primary outcome analysis indicated efficacy of ziprasidone versus placebo (p = 0.0038. Efficacy was more pronounced in type II bipolar disorder than in MDD (p = 0.036. Overall ziprasidone was well tolerated, without notable worsening of weight or extrapyramidal symptoms. CONCLUSIONS: There was a statistically significant benefit with ziprasidone versus placebo in this first RCT of any medication for the provisional diagnostic concept of the depressive mixed state. TRIAL REGISTRATION: Clinicaltrials.gov NCT00490542.