Double-blind randomized controlled trial of rolls fortified with microencapsulated iron Estudo duplo-cego randomizado controlado com pães fortificados com ferro microencapsulado

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Teresa Negreira Navarro Barbosa

2012-02-01

Full Text Available OBJECTIVE: To evaluate the impact of the fortification of rolls with microencapsulated iron sulfate with sodium alginate on the hemoglobin levels in preschoolers as compared to controls. METHODS: Double-blind randomized controlled trial comprised of children aged 2 to 6 years with initial hemoglobin exceeding 9 g/dL from four not-for-profit daycares randomly selected in the city of São Paulo - Brazil. Children of 2 daycares (n = 88 received rolls with fortified wheat flour as the exposed group (EC and children of 2 daycares (n = 85 received rolls without fortification as the control group (CG over a 24-week period. Rolls with 4 mg iron each were offered once a day, five days a week. Hemoglobin concentrations were determined in capillary blood by HemoCue® at three moments of trial: baseline (Ml, after 12 and 24 weeks of intervention (M2, M3. RESULTS: Hemoglobin concentration presented significant increase up to M3 in EG (11.7-12.5-12.6 g/dL and in CG (11.1-12.4-12.3 g/dL with higher elevations in children initially with anemia. There was significant reduction in the occurrence of anemia from 22% to 9% in EG and from 47% to 8.2% in CG at M3. CONCLUSION: Rolls fortified with microencapsulated iron sulfate were well tolerated, increased hemoglobin levels and reduced the occurrence of anemia, but with no difference compared to the control group.OBJETIVO: A deficiência de ferro é a carência nutricional mais frequente no Brasil, tendo como principal etiologia a baixa ingestão do mineral. A fortificação alimentar é medida sustentável e de melhor custo-benefício para a prevenção e controle. O objetivo foi avaliar o impacto da fortificação de pães com sulfato ferroso microencapsulado com alginato de sódio sobre os níveis de hemoglobina em pré-escolares, comparados com controles. MÉTODOS: Estudo duplo-cego randomizado controlado incluindo crianças de 2 a 6 anos com hemoglobina inicial maior que 9 g/dL procedentes de 4 creches filantr

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

¿Hay un rol para los agentes biológicos en el tratamiento de la patología pulmonar intersticial asociada a enfermedades del tejido conectivo?

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Quadrelli, Silvia; Dubinsky, Diana; Alvarez, Sabrina

2016-01-01

Excepto en la esclerodermia, no hay ensayos clínicos controlados válidos para guiar la decisión de tratamiento en enfermedad pulmonar intersticial asociada a enfermedades del tejido conectivo (EPID-ETC). Los únicos dos estudios randomizados, controlados, publicados en pacientes con esclerodermia, mostraron un beneficio modesto pero significativo del uso de ciclofosfamida, y la transformaron en el esquema más convencional de tratamiento de toda la EPID-ETC. Los tratamientos iniciales aceptados...

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.

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

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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...

Avaliação da utilização do placebo nas crises agudas de migrânea sem aura, migrânea com aura e cefaléia do tipo tensional episódica Evaluation of placebo use in migraine without aura, migraine with aura and episodic tension-type headache acute attacks

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Marcelo Eduardo Bigal

2001-09-01

Full Text Available O presente estudo apresenta a avaliação do efeito placebo no tratamento agudo da migrânea sem aura, migrânea com aura e cefaléia do tipo tensional episódica. Foram estudados pacientes que deram entrada entre 1 de março de 1997 a 31 de novembro de 1999 em dois pronto-socorros. Definiram-se três grupos, cada um com 30 pacientes: 1 - migrânea sem aura (MSA; 2 -- migrânea com aura (MCO; 3 -- cefaléia do tipo tensional episódica (CTTE. Os pacientes participavam de estudo randomizado para avaliar a eficácia de 4 drogas; aqueles randomizados para o placebo foram incluídos também. Os parâmetros avaliados foram: 1 -- dor; 2 - sintomas associados. Avaliados uma hora após a administração do placebo, 50% dos pacientes do grupo MSA, 23,3% dos pacientes do grupo MCA e 26,7% dos pacientes do grupo CTTE apresentavam melhora da dor. A melhora, avaliada pela escala numérica da dor foi, em média, de 41,6%, 23,1% e 36%, respectivamente. Houve também redução significativa de todos os sintomas associados. A utilização do placebo é, portanto, essencial na avaliação de drogas utilizadas no tratamento de cefaléias agudas.This study presents an evaluation of placebo response in the acute treatment of migraine with or without aura and episodic tension type headache. We studied patients admitted between March 1st,1997 and November 31st,1999 in two Emergency Room Units. Three groups had been defined, each one with 30 participants: migraine without aura (MWOA, migraine with aura (MWA and episodic tension-type headache (ETTH. Patients were participating of a randomized study to evaluate efficacy of 4 different drugs; those randomized to receive placebo were included. We evaluated pain and associated symptoms. After one hour of placebo administration, 50% of MWOA patients, 23.3% of MWA and 26.7% of ETTH had presented pain relief. The mean of this relief, evaluated by the numerical pain scale, was 41.6%, 23.1% and 36%, respectively. Use of placebo

CPAP em selo d'água versus CPAP com fluxo variável em recém-nascidos com desconforto respiratório: um ensaio controlado randomizado

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Ana Cristina Zanon Yagui

2011-12-01

Full Text Available OBJETIVO: Avaliar a eficácia e segurança da pressão positiva contínua na via aérea (CPAP utilizando aparelhos de fluxo variável e fluxo contínuo em selo d'água, quanto a falha do CPAP, ocorrência de escape de ar, tempo de uso de CPAP e de oxigênio e tempo de internação em unidade de terapia intensiva e hospitalar em neonatos com desconforto respiratório (DR moderado e peso de nascimento (PN > 1.500 g. MÉTODOS: Quarenta recém-nascidos que necessitavam de CPAP foram randomizados em dois grupos: um grupo tratado com fluxo variável (FV e outro com fluxo contínuo (FC. O estudo foi realizado entre outubro de 2008 e abril de 2010. Foram registrados dados demográficos, falha do CPAP, ocorrência de escape de ar, tempo de uso de CPAP e de oxigênio, entre outros. Os desfechos categóricos foram analisados com o teste do qui-quadrado ou exato de Fisher e as variáveis contínuas com o teste de Mann-Whitney, com significância de p 1.500 g e DR moderado, o CPAP nasal com fluxo contínuo apresentou os mesmos benefícios do CPAP nasal com fluxo variável.

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

Reducao do uso de acucar em escolas publicas: ensaio randomizado por conglomerados

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Rita Adriana Gomes de Souza

2013-08-01

Full Text Available OBJETIVO Analisar a eficácia de ações de educação nutricional com merendeiras na redução da adição de açúcar na alimentação escolar e no próprio consumo. MÉTODOS Ensaio randomizado por conglomerado, controlado, conduzido em 20 escolas municipais na cidade metropolitana de Niterói, RJ, de março a dezembro de 2007. Programa de educação nutricional foi implementado nas escolas de intervenção, junto a merendeiras, usando mensagens, atividades e material educativo que encorajassem a redução da adição de açúcar na alimentação escolar e no consumo. A redução da disponibilidade de açúcar pelas escolas foi analisada por planilhas com dados da utilização dos itens do estoque. O consumo individual das merendeiras foi avaliado pelo uso de questionário de frequência de consumo alimentar. As medidas antropométricas foram realizadas de acordo com técnicas padronizadas e a variação na mudança do peso foi medida ao longo do estudo. RESULTADOS A redução da disponibilidade de açúcar ocorreu mais acentuadamente nas escolas de intervenção quando comparadas às escolas controle (-6,0 kg versus 3,4 kg, sem diferença estatisticamente significante (p = 0,21, embora o poder do estudo tenha sido baixo. Houve redução do consumo de doces e bebidas açucaradas nos dois grupos, mas o consumo de açúcar não apresentou diferenças estatisticamente significativas entre eles. Houve redução do peso e do consumo de energia total nos dois grupos, mas sem diferença estatisticamente significante entre eles e sem modificação dos percentuais de adequação dos macronutrientes em relação ao consumo de energia. CONCLUSÕES Não foi possível provar que a estratégia de redução da disponibilidade e do consumo de açúcar por merendeiras de escolas públicas se mostrou eficaz.

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

Efficacy and safety of dynamic stabilization for patients with degenerative disc, spinal stenosis and low back pain: a systematic review of randomized controlled clinical trials Eficacia y seguridad de los sistemas de estabilización dinámica en pacientes con enfermedad discal degenerativa, estenosis de canal y lumbalgia: revisión sistemática de estudios clínicos randomizados Eficácia e segurança dos sistemas de estabilização dinâmica em pacientes com doença discal degenerativa, estenose de canal e lombalgia: revisão sistemática de estudos clínicos randomizados

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Gustavo Carriço de Oliveira

2010-09-01

para cada tipo de estudio. REVISIÓN DE LITERATURA: publicaciones recientes han aumentado el debate acerca del papel de los sistemas de estabilización dinámica en el tratamiento del dolor lumbar crónico asociado a la degeneración discal lumbar y estenosis de canal lumbar. Fue conducida una revisión sistemática de ensayos randomizados a través de la estrategia de búsqueda apurada y selección con criterios aplicados para cada tipo de estudio. MÉTODOS: una revisión de la literatura a través de las siguientes fuentes fue realizada: Cochrane Central Register of Controlled Trials, MEDLINE, Excerpta Medica database (EMBASE y Literatura latino-Americana y del Caribe en Ciencias de la Salud (LILACS. La revisión pudo identificar los estudios clínicos randomizados o no. No hubo restricción de idioma y la fecha límite de búsqueda fue 31 de noviembre de 2008. RESULTADOS: un ensayo controlado randomizado, que llenó los criterios de inclusión descritos encima, fue incluido en esto estudio. CONCLUSIÓN: los datos incluidos en esta revisión muestran que el uso de los sistemas de estabilización sin fusión son una alternativa aceptable para el tratamiento de pacientes con estenosis de canal lumbar y enfermedad degenerativa discal en pacientes bien seleccionados. Esta revisión destaca la necesidad de investigación continuada sobre el uso de los sistemas de estabilización dinámica para tratamiento de las patologías de la columna vertebral. Existe una necesidad urgente para la conducción de ensayos clínicos randomizados. La eficacia a largo plazo debe de ser evaluada.DESENHO DE ESTUDO: Revisão sistemática da literatura. OBJETIVO: Realizar revisão sistemática da literatura para organizar, avaliar e selecionar evidências a respeito do uso dos sistemas de estabilização dinâmica, sua eficácia e segurança no tratamento da doença degenerativa discal, estenose do canal lombar e dor lombar. REVISÃO DE LITERATURA: Publicações recentes têm aumentado o

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

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

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

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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

A randomized, controlled, crossover trial of oral midazolam and hydroxyzine for pediatric dental sedation Sedação com midazolam e hidroxizina por via oral em Odontopediatria: ensaio clínico randomizado, controlado e cruzado

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Alessandra Rodrigues de Almeida Lima

2003-09-01

Full Text Available The effectiveness of oral midazolam in pediatric dentistry is controversial. This randomized, controlled, crossover, double blind clinical trial was conducted in order to study the effect of midazolam, used either alone or in association with hydroxyzine, during child dental treatment. Thirty seven dental sedation sessions were carried out on 11 ASA I uncooperative children less than five years-old. In each appointment children were randomly assigned to groups: P - placebo, M - midazolam (1.0 mg/kg, or MH - midazolam (0.75 mg/kg plus hydroxyzine (2.0 mg/kg. Vital signs (blood pressure, breathing rate, pulse and oxygen saturation and behavior parameters (consciousness, crying, movement, overall behavior were evaluated every 15 minutes. Friedman and Wilcoxon statistical tests were used to compare groups and different moments in the same group. Normal values of vital signs were usually registered. Heart rate increased in groups P and M as the session went on. Group M presented less crying and movement at the first 15 minutes of treatment. Group MH caused more drowsiness at the beginning of the session. Overall behavior was better in group M than in groups P or MH. Group M produced effective sedation in 77% of the cases, and group MH did so in 30.8%. It was concluded that midazolam was effective and safe, and its association with hydroxyzine did not lead to additional advantages in pediatric dental sedation.Há controvérsias quanto aos benefícios do midazolam na sedação de crianças durante a atenção odontológica. Conduziu-se um ensaio clínico controlado, cruzado e duplo-cego para comparar o efeito sedativo em Odontopediatria da administração oral do midazolam, associado ou não à hidroxizina. Trinta e sete sessões foram realizadas em 11 crianças menores de cinco anos, ASA I. Em cada atendimento, os pacientes receberam aleatoriamente o medicamento conforme os grupos: P - placebo, M - midazolam (1,0 mg/kg; MH - midazolam (0,75 mg

Efeito da catuama® na sintomatologia da síndrome da ardência bucal: ensaio clínico, randomizado, duplo-cego, placebo-controlado

OpenAIRE

Spanemberg, Juliana Cassol

2011-01-01

A síndrome da ardência bucal (SAB) é uma doença de etiopatogenia desconhecida, caracterizada pela sensação de queimação e ardência na mucosa bucal, que se apresenta clinicamente normal. Fármacos antidepressivos, benzodiazepínicos e antipsicóticos são as opções terapêuticas mais utilizadas no tratamento da SAB. Estudos têm demonstrado que o fitoterápico Catuama® , composto por quatro extratos de plantas medicinais (Paullinia cupana, Trichilia catigua, Zingiber officinalis e Ptychopetalum olaco...

Cineantropometría: composición corporal y somatotipo de futbolistas que desarrollan su actividad física en equipos de la Comunidad Autónoma de Madrid

OpenAIRE

Herrero de Lucas, Ángel

2004-01-01

Definimos Cineantropometría como el estudio del tamaño, forma, proporcionalidad, composición, maduración biológica y función corporal; con objeto de entender el proceso del crecimiento, el ejercicio, el rendimiento deportivo y la nutrición. OBJETIVOS: Estudio controlado, transversal, no randomizado, de tipo observacional y analítico cineantropométrico. MATERIAL Y METODO: Utilizamos el protocolo de medidas establecido por la Sociedad Internacional para el Avance de la Cineantropometría (I.S.A....

Falla cardiaca, tratamiento: diuréticos, inhibidores de la ECA y nitratos

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Guillermo Trout Guardiola

2013-01-01

En los pasados 15 años grandes ensayos clínicos randomizados, controlados, han revolucionado el manejo de pacientes con falla cardiaca. Aunque es claro que algunas drogas mejoran los síntomas, otras presentan beneficios pronósticos y sintomáticos, el manejo de falla cardiaca se debe centralizar en mejorar la calidad de vida y la sobrevida. Los diuréticos y los inhibidores de la enzima convertidora de la angiotensina, combinados con medidas no farmacologicas, permanecen como el tratamiento con...

O efeito da hidroterapia na dor, qualidade de vida e funcionalidade em pacientes com fibromialgia

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Rocha, Virgílio

2016-01-01

Projeto de Graduação apresentado à Universidade Fernando Pessoa como parte dos requisitos para obtenção do grau de Licenciado em Fisioterapia Objetivo: Sistematizar a evidência científica existente sobre o papel do efeito da Hidroterapia na Dor, Qualidade de Vida e Funcionalidade em pacientes com Fibromialgia Métodos: Estudo de revisão incluindo estudos randomizados controlados, pesquisados nas bases de dados PubMed, EBSCO, PEDro e Web of Science, com doentes com fibromialgia, cujo tipo de...

Trimetazidina e resposta inflamatória em cirurgia de revascularização do miocárdio

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Gerez Fernandes Martins

2012-08-01

Full Text Available FUNDAMENTO: A resposta inflamatória orgânica constitui um mecanismo fisiopatológico presente em todas as cirurgias de revascularização do miocárdio com circulação extracorpórea (CRVM-CEC, e a liberação de mediadores inflamatórios constitui um de seus mecanismos de defesa. OBJETIVO: Avaliar, em estudo prospectivo duplo-cego randomizado e controlado com placebo, os efeitos da trimetazidina (Tmz sobre a resposta inflamatória, por meio da variação nas interleucinas 6 e 8; TNF-α; complementos C3 e C5, e na proteína C reativa ultrassensível (PCR-us, em dois momentos, pré e pós-operatório. MÉTODOS: Foram estudados 30 pacientes submetidos a CRVM-CEC utilizando cardioplegia hipotérmica intermitente, e com no máximo disfunção ventricular leve, divididos em dois grupos (placebo e Tmz, estratificados por ecocardiografia e recebendo medicação/placebo na dose de 60mg/dia. As amostras foram dosadas no pré-operatório sem medicação, no dia da cirurgia com 12 a 15 dias de medicação/placebo e, seguidamente, 5 min após o desclampeamento aórtico, 12 e 24h, para interleucinas e complementos, e 48h para PCR. RESULTADOS: Não ocorreram diferenças significativas entre os níveis de interleucina 8, Tnf-α, complementos C3 e C5, e PCR-us. No entanto, no grupo tratado, os níveis de interleucina 6 foram significativamente inferiores aos do grupo controle, em todos os momentos analisados. CONCLUSÃO: A trimetazidina mostrou-se eficaz apenas na redução da interleucina 6 nos pacientes submetidos à CRVM.

Musicoterapia Baseada em Evidências: Contribuições de Ensaios Controlados Randomizados (ECR's)

DEFF Research Database (Denmark)

Gattino, Gustavo

2016-01-01

This lecture deals with the relevance of Randomized Controlled Trials (RCTs) in music therapy and their importance for the clinical practice. Considerations of the last RCTs in music therapy are presented. Moreover, it is highlighted that RCTs are not the most important design and they don't subs...

RECONSTRUCCIÓN DEL MAXILAR SUPERIOR POSTERIOR ATRÓFICO CON CÉLULAS MADRE MESENQUIMALES

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Martí Pagès, Carles

2009-01-01

Se realiza un estudio clínico en el lnstituto de Cirugía Maxilofacial e Implantologia tras pasar el comité ético del Centro Medica Teknon. Es un estudio randomizado, controlado utilizando un diseño tipo "split mouth" en el cual cada paciente sirve de propio control. SE realiza a 5 pacientes, con atrofia posterior del maxilar superior sin posibilidad de instalar implantes fueron tratados con reconstrucción mediante la técnica de elevación sinusal bilateral, rellenando un sena con Bio-as...

APORTES DE LAS DOULAS A LA OBSTETRICIA MODERNA

OpenAIRE

Valdés L.,Verónica; Morlans H.,Ximena

2005-01-01

Este artículo tiene como objetivo realizar una revisión de la evidencia disponible en relación con la presencia de una "doula" durante el parto. Llamamos "doula" a una mujer que acompaña a otra durante el trabajo de parto y parto, brindando apoyo emocional continuo durante este periodo. Desde hace 25 años se han realizado múltiples estudios randomizados controlados para evaluar el efecto del acompañamiento de una "doula" en el parto. Los resultados son sorprendentes, significativos y consiste...

Effect of enamel matrix proteins on the treatment of intrabony defects: a split-mouth randomized controlled trial study O efeito da proteína da matriz do esmalte no tratamento de defeitos infra-ósseos: um estudo clínico controlado randomizado boca-dividida

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Daniela Chambrone

2007-09-01

Full Text Available The objective of this split-mouth, double-blind, randomized controlled trial was to compare the clinical effect of treatment of 2- or 3-wall intrabony defects with open flap debridement (OFD combined or not with enamel matrix proteins (EMP. Thirteen volunteers were selected with one pair of or more intrabony defects and probing pocket depth (PPD > 5 mm. All individuals received instructions regarding oral hygiene and were submitted to scaling and root planing. Each participant received the two treatment modalities: test sites were treated with OFD and EMP, and control sites received only OFD. After 6 months, a significant reduction was observed in PPD for the EMP group (from 6.42 ± 1.08 mm to 2.67 ± 1.15 mm and for the OFD group (from 6.08 ± 1.00 mm to 2.00 ± 0.95 mm (p O objetivo deste estudo clínico controlado, randomizado, duplo-cego, tipo boca-dividida foi comparar o efeito clínico do tratamento de defeitos infra-ósseos de 2 ou 3 paredes com retalho de espessura total (RET associado ou não com a proteína da matriz do esmalte (PME. Treze voluntários com 1 par ou mais de defeitos infra-ósseos foram selecionados com profundidade clínica de sondagem (PCS > 5 mm. Todos receberam instruções de higiene bucal, raspagem e alisamento radicular. Cada participante recebeu os dois tipos de tratamento: o lado teste foi tratado com RET e PME, e o lado controle recebeu somente RET. Após 6 meses, foi observada uma redução significante na PCS para o grupo PME (de 6,42 ± 1,08 mm para 2,67 ± 1,15 mm e para o grupo RET (de 6,08 ± 1,00 mm para 2,00 ± 0,95 mm (p < 0,0001, mas não houve diferença significante entre os grupos (p = 0,13. Um ganho significante de nível clínico de inserção relativo (NCIR foi observado em ambos os grupos (PME: de 13,42 ± 1,88 mm para 10,75 ± 2,26 mm, p < 0,001; RET: de 12,42 ± 1,98 mm para 10,58 ± 2,23 mm, p = 0,013, mas não houve diferença significante entre os grupos (p = 0,85. A retração gengival

Hábitos Alimentares, Atividade Física e Escore de Risco Global de Framingham na Síndrome Metabólica

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Thays Soliman Soares

2014-04-01

Full Text Available Fundamento: A síndrome metabólica é um transtorno complexo representado por um conjunto de fatores de risco cardiovascular. A adoção de um estilo de vida saudável está fortemente relacionada à melhora da Qualidade de Vida e interfere de forma positiva no controle dos fatores de risco presentes nessa condição clínica. Objetivo: Avaliar o efeito de um programa de modificação do estilo de vida sobre o Escore de Risco Cardiovascular Global de Framingham em indivíduos com síndrome metabólica. Método: Trata-se de uma subanálise de um ensaio clínico randomizado, controlado, cegado, com duração de três meses. Os participantes foram randomizados em quatro grupos: intervenção nutricional + placebo (INP, intervenção nutricional + suplementação de ácidos graxos ômega 3 (3 g/dia de óleo de peixe (INS3, intervenção nutricional + atividade física + placebo (INEP e intervenção nutricional + atividade física + suplementação de ácidos graxos ômega 3 (INES3. O Escore de Risco Cardiovascular Global de Framingham de cada indivíduo foi calculado antes e após a intervenção. Resultados: Participaram do estudo 70 indivíduos. Observou-se uma redução da média do escore após a intervenção de forma geral (p < 0,001. Obteve-se uma redução para risco intermediário em 25,7% dos indivíduos. Após a intervenção, observou-se redução significativa (p < 0,01 da "idade vascular", sendo esta mais expressiva nos grupos INP (5,2% e INEP (5,3%. Conclusão: Todas as intervenções propostas produziram efeito benéfico para a redução do escore de risco cardiovascular. O presente estudo reforça a importância da modificação do estilo de vida na prevenção e no tratamento das doenças cardiovasculares.

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.

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...

Efeito do método Pilates em fatores de risco para doenças cardiometabólicas: uma revisão sistemática = Effect of Pilates exercises in risk factors for cardiometabolic diseases: a systematic review

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Junges, Silvana

2015-01-01

Conclusões: O Pilates está se conso lidando como um exercício eficaz na redução de porcentagem de gordura corporal, massa gorda, relação cintura/quadril e da pressão arterial em indivíduos de diferentes faixas etárias. Esses benefícios, principalmente da redução da relação cintura/quadril e pressão arterial têm um impacto clinicamente relevante na morbimortalidade por doenças cardio vasculares e cerebrovasculares. Contudo, mais estudos randomizados e controlados necessitam ser conduzidos nessa área

Prática mental após fisioterapia mantém mobilidade funcional de pessoas com doença de Parkinson

OpenAIRE

Monteiro, Douglas; Silva, Liliane Pereira da; Sá, Priscila Oliveira de; Oliveira, Alisson Luiz Ribeiro de; Coriolano, Maria das Graças Wanderley de Sales; Lins, Otávio Gomes

2018-01-01

RESUMO O objetivo deste estudo foi avaliar a prática mental após a fisioterapia motora para manutenção dos efeitos obtidos na mobilidade funcional de pessoas com doença de Parkinson (DP). Este ensaio clínico randomizado controlado, com cegamento simples, incluiu 14 sujeitos com DP nos estágios de 1 a 3 (escala de Hoehn & Yahr), com idade entre 45 e 72 anos. Após a avaliação inicial com o Timed Up & Go (TUG), Dynamic Gait Index (DGI) e Falls Efficacy Scale - International Brazil (FES-I Brasil)...

Efeito do uso profilático do anti-inflamatório não-esteroide ibuprofeno sobre o desempenho em uma sessão de treino de força

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Cleiton Silva Correa

2013-04-01

Full Text Available INTRODUÇÃO: Medicamentos anti-inflamatórios não esteroides, como o ibuprofeno, têm sido utilizados por atletas de várias modalidades com o intuito de aumentar desempenho esportivo. OBJETIVO: Verificar o efeito do uso profilático de ibuprofeno sobre desempenho em uma sessão de treino de força. MÉTODOS: Um ensaio clínico, cruzado, randomizado, duplo-cego e placebo-controlado foi desenvolvido com 12 praticantes regulares de treino de força do sexo masculino, os quais realizaram uma sessão de treino após a ingestão de ibuprofeno (1,2 g e uma outra após a ingestão de placebo. Seis séries dos exercícios supino e agachamento foram realizadas em cada sessão de treino com uma carga constante correspondente a 65% da 1RM de cada exercício. O desempenho no treinamento foi mensurado através do número de repetições que os voluntários conseguiram realizar em cada série de exercício a cada sessão de treino de força. RESULTADOS: Não foram verificadas diferenças significativas de desempenho no treino de força com a administração prévia de placebo ou ibuprofeno (p > 0,05. CONCLUSÃO: A ingestão de ibuprofeno nos parâmetros de administração adotados pelo presente estudo não promove qualquer tipo de alteração na tolerância ao exercício em uma sessão isolada de treino de força, o que contraria a indicação dessa substância para fins ergogênicos no treino de força.

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

Alterações lipídicas em pacientes com câncer colorretal em fase pós-operatória: ensaio clínico randomizado e duplo-cego com fungos Agaricus sylvaticus Lipidic alterations in patients with colorectal cancer in post-surgery phase: a randomized and double-blind clinical trial with Agaricus sylvaticus fungus

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Renata Costa Fortes

2008-09-01

Full Text Available INTRODUÇÃO: Alterações no metabolismo lipídico são comuns em pacientes com câncer. Fungos medicinais podem exibir atividade hipolipidêmica. OBJETIVO: Avaliar os efeitos da suplementação dietética com fungos Agaricus sylvaticus no perfil lipídico de pacientes com câncer colorretal em fase pós-operatória. MÉTODOS: Ensaio clínico randomizado, duplo-cego, placebo-controlado, realizado no Hospital de Base do Distrito Federal por seis meses. Amostra constituída por 56 pacientes, estádios I, II e III, separados em dois grupos: placebo e suplementado com Agaricus sylvaticus (30mg/kg/dia. Resultados analisados pelos programas Microsoft Excel 2003 e SPSS 14.0 com p = 0.05. RESULTADOS: O grupo Agaricus sylvaticus apresentou níveis séricos iniciais de colesterol total de 207.36±52.67mg/dL, lipoproteína de baixa densidade de 120.79±44.02mg/dL e triglicérides de 181.64±187.52mg/dL. Após seis meses de suplementação, observou-se redução para 191.11±39.72mg/dL (p = 0.01, 103.08±39.20mg/dL (p = 0.0001 e 168.04±146.91mg/dL (p = 0.18, respectivamente. No grupo placebo, observou-se aumento não-significativo de colesterol total (p = 0.08 e aumento significativo de lipoproteína de baixa densidade (p = 0.01 e triglicérides (p = 0.0001. Não foram observadas, em ambos os grupos, alterações significantes nos níveis de lipoproteína de alta densidade e lipoproteína de muito baixa densidade. CONCLUSÃO: Os resultados sugerem que a suplementação dietética com Agaricus sylvaticus pode melhorar significativamente o perfil lipídico de pacientes com câncer colorretal em fase pós-operatória.INTRODUCTION: Alterations in the lipidic metabolism are common in patients with cancer. Medicinal fungus may show hypolipidemic activity. OBJECTIVE: To evaluate the effects of dietary supplementation with Agaricus sylvaticus fungus in lipidic profile of patients with colorectal cancer in post-surgery phase. MEHTODS: Randomized, double

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...

Ácidos graxos ômega 3 e tratamento da esquizofrenia Omega 3 fatty acid and schizophrenia treatment

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Juliane Costa Silva Zemdegs

2010-01-01

Full Text Available CONTEXTO: A esquizofrenia é uma desordem psiquiátrica complexa e debilitante cujo tratamento de base é realizado com medicamentos antipsicóticos. No entanto, evidências sugerem que a suplementação dietética com ácidos graxos ômega 3 (n-3 pode ser benéfica em diversas desordens psiquiátricas. OBJETIVO: Revisar a eficácia do n-3 como coadjuvante no tratamento farmacológico da esquizofrenia. MÉTODOS: Realizou-se uma pesquisa nas bases de dados eletrônicas Medline, Lilacs e SciELO. A estratégia de busca também incluiu a busca em árvore. Todos os estudos randomizados e controlados relevantes foram incluídos nesta revisão, independentemente do ano de publicação. RESULTADOS: Até o momento, foram divulgados seis estudos randomizados, duplo-cegos placebo controlados; cinco deles apresentaram resultados positivos na melhora dos sintomas da esquizofrenia, assinalando, ainda, superioridade do ácido graxo eicosapentaenoico (EPA em relação ao ácido graxo docosaexaenoico. Em geral, o consumo de 2 g/dia de EPA conjuntamente com a medicação antipsicótica usual parece reduzir a sintomatologia da esquizofrenia, particularmente os sintomas positivos. CONCLUSÃO: A terapia nutricional com EPA mostrou-se útil como coadjuvante no tratamento da esquizofrenia. Por conseguinte, sugere-se que os pacientes esquizofrênicos sejam encorajados a consumir refeições balanceadas e saudáveis ricas em EPA e, caso a quantidade ideal não seja atingida pela dieta, a suplementação pode ser benéfica.BACKGROUND: Schizophrenia is a complex and debilitating psychiatric disorder, whose primary pharmacological intervention is the use of antipsychotics. There is, however, growing evidence that dietary supplementation with omega 3 fatty acids (n-3 may be beneficial in several psychiatric conditions. OBJECTIVE: To review the efficacy of n-3 as a treatment for schizophrenia. METHODS: Electronic searches of the following databases were performed: Medline

O tratamento farmacológico do transtorno bipolar: uma revisão sistemática e crítica dos aspectos metodológicos dos estudos clínicos modernos The pharmacological treatment of bipolar disorder: a systematic and critical review of the methodological aspects of modern clinical trials

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Elie Cheniaux

2011-03-01

Full Text Available OBJETIVO: Revisar sistematicamente os principais estudos clínicos sobre o tratamento farmacológico do transtorno bipolar e fazer uma análise crítica de seus aspectos metodológicos. MÉTODO: Realizou-se uma busca nas bases de dados Medline, ISI e PsycINFO, utilizando-se os seguintes termos de busca: "bipolar", "randomized", "placebo" e "controlled". Foram selecionados estudos clínicos randomizados, duplo-cegos e controlados por placebo sobre o tratamento farmacológico do transtorno bipolar. Além disso, de acordo com os nossos critérios, as amostras deveriam ser de no mínimo 100 pacientes e a substância testada deveria ser usada como monoterapia. RESULTADOS: 34 artigos se adequaram aos critérios de seleção. Todas as substâncias atualmente indicadas para mania, depressão bipolar e para o tratamento de manutenção foram mais eficazes que o placebo em pelo menos um estudo. Todavia, esses estudos tiveram amostras altamente selecionadas, altas taxas de abandono e baixas taxas de resposta clínica. CONCLUSÃO: Os modernos estudos clínicos sobre o tratamento farmacológico do transtorno bipolar apresentam algumas importantes limitações metodológicas. Assim, seus resultados devem ser considerados com cautela.OBJECTIVE: To review systematically the main clinical trials on the pharmacological treatment of bipolar disorder and to make a critical analysis of their methodological aspects. METHOD: A search in Medline, ISI and PsycINFO databases was conducted, using the following search terms: "bipolar", "randomized", "placebo" e "controlled". Randomized, double-blind, placebo-controlled clinical trials on the pharmacological treatment of bipolar disorder were selected. Besides, according to our criteria, samples had to consist of at least 100 patients and experimental drug had to be used as monotherapy. RESULTS: 34 articles met our selection criteria. All drugs currently indicated for mania, bipolar depression and maintenance treatment of

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...

Toxicology and safety of the tincture of Operculina alata in patients with functional constipation

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Luciana Kelly Ximenes dos Santos

2012-09-01

Full Text Available The tincture of Operculina alata, popularly known as "tincture of jalapa", is used in Northeast Brazil to treat constipation and encephalic vascular accident, but it has not yet been adequately tested for safety and efficacy. The aim of this study was to evaluate the toxicology and safety of the tincture of O. alata in patients with functional constipation. This was a double-blind, randomized, placebo-controlled clinical trial. The study consisted of three phases: pre-treatment, treatment and post-treatment, each phase with duration of seven days. Arterial pressure, heart rate, body weight, adverse events, hematological, metabolic, liver and kidney functions were monitored. Forty patients were randomized to receive tincture of O. alata and 43 patients to receive placebo. There were statistical differences in the clinical aspects between groups, but these changes were not considered clinically significant. Adverse events were considered not serious and of mild intensity, especially dizziness, headache, abdominal pain and nausea. This clinical trial confirmed the safety of the tincture of O. alata in the pharmaceutical form and dosage tested, allowing the product to be safely used in a larger population for the assessment of its clinical efficacy.A tintura de Operculina alata, popularmente conhecida como "tintura de jalapa", é usada no Nordeste do Brasil para tratar constipação intestinal e acidente vascular encefálico, mas sua eficácia e segurança ainda não foram confirmadas. O objetivo deste estudo foi avaliar a toxicologia e segurança da tintura de O. alata em pacientes com constipação intestinal funcional. Este foi um ensaio clínico duplo-cego, randomizado e controlado por placebo. O estudo consistiu de três fases: pré-tratamento, tratamento e pós-tratamento, cada fase com duração de sete dias. Foram monitorizados a pressão arterial, frequência cardíaca, peso corporal, eventos adversos e funções hematológica, metab

Effect of pelvic floor muscle training on labour and newborn outcomes: a randomized controlled trial Efeitos do treinamento da musculatura do assoalho pélvico sobre o parto e recém-nascido: estudo controlado randomizado

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Letícia A. R. Dias

2011-12-01

Full Text Available BACKGROUND: The use of the pelvic floor muscle training for urinary incontinence treatment is well established but little is known about its effects in labor and newborn outcomes. OBJECTIVES: To evaluate the effects of antenatal pelvic floor muscle training and strength in labor and newborn outcomes in low-income pregnant women. METHODS: This is a randomized controlled trial that recruited forty-two nulliparous healthy pregnant women aged between 18-36 years old and able to contract the pelvic floor muscles. The participants were included in the study with 20 weeks of gestational age and had their pelvic floor muscles measured by vaginal squeeze pressure. They were randomly allocated into two groups: training group and a non-intervention control group. Then, all participants had their labor and newborn outcomes evaluated through consultation of medical records by a blinded researcher. RESULTS: There were no statistically significant differences between the groups regarding gestational age at birth, type of labor, duration of the second stage of labor, total time of labor, prevalence of laceration, weight and size of the baby, and Apgar score. No correlation was observed between pelvic floor muscle strength and the second stage or the total length of labor. CONCLUSIONS: This randomized controlled trial did not find any effect of pelvic floor muscle training or pelvic floor muscle strength on labor and newborn outcomes.CONTEXTUALIZAÇÃO: O treinamento da musculatura do assoalho pélvico para tratamento da incontinência urinária é bem estabelecida, mas pouco se sabe sobre seus efeitos sobre o parto e o recém-nascido. OBJETIVOS: Avaliar se os desfechos do parto e os resultados dos recém-nascidos são influenciados pelo treinamento e força da musculatura do assoalho pélvico realizados por gestantes de baixa renda. MÉTODOS: Trata-se de um ensaio clínico randomizado que incluiu 42 gestantes nulíparas de baixo risco, com idade entre 18 e 36

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].

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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.

A critical analysis of studies assessing L-ornithine-L-aspartate (LOLA in hepatic encephalopathy treatment Uma análise crítica dos estudos de avaliação do L-ornitina-L-aspartato (LOLA no tratamento da encefalopatia hepática

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Patrícia Coelho de Soárez

2009-09-01

Full Text Available CONTEXT: Experimental and clinical studies suggest that LOLA may have a favorable influence on hepatic encephalopathy due to the effect on the reduction of ammonia, and improvement of the symptoms and laboratory findings. OBJECTIVES: To evaluate and to critically analyze the efficacy and/or effectiveness results of the use of LOLA when compared to placebo in the treatment of hepatic encephalopathy. DATA SOURCES: LILACS, SciELO, MEDLINE, PubMed database and Cochrane Collaboration Register of Controlled Trials were searched from 1966 to September of 2006. The review has included all the randomized controlled double-blind clinical trials performed in humans in English language. RESULTS: Four studies published between 1993 and 2000 were selected and reviewed. LOLA was showed as being able to reduce hyperammonemia in patients with hepatic encephalopathy, when compared to patients in the placebo group. CONCLUSIONS: Although the trials have shown efficacy of LOLA in reducing hyperammonemia of hepatic encephalopathy, sufficient evidence of a significant beneficial effect of LOLA on patients with hepatic encephalopathy was not found. The studies performed in this area were small, with short follow-up periods and half of them showed low methodological quality.CONTEXTO: Estudos experimentais e clínicos sugerem que a L-ornitina-L-aspartato pode ter uma influência favorável na encefalopatia hepática em virtude do seu efeito na redução da amônia, e melhora dos sintomas e achados laboratoriais. OBJETIVOS: Avaliar e analisar criticamente os estudos de eficácia e/ou efetividade do uso de L-ornitina-L-aspartato quando comparado com placebo no tratamento da encefalopatia hepática. FONTES DE INFORMAÇÃO: Foram pesquisadas as bases de dados LILACS, SciELO, MEDLINE, PubMed e o Registro de Ensaios Controlados da Colaboração Cochrane no período de 1966 até setembro de 2006. A revisão incluiu todos os ensaios clínicos controlados randomizados, duplo

Perioperative effects of oral midazolam premedication in children undergoing skin laser treatment: a double-blinded randomized placebo-controlled trial Efeitos peroperatórios da premedicação oral de midazolam em crianças submetidas a tratamento de pele por laser: estudo duplo-cego randomizado e controlado

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Mehrdad Shoroghi

2011-08-01

Full Text Available PURPOSE: To investigate and compare the efficacy of oral midazolam with two different dosages in orange juice on perioperative hemodynamics and behavioral changes in children who underwent skin laser treatment in an academic educational Hospital. METHODS: Ninety children, candidates for skin laser treatment were randomly assigned to 1 of 3 groups of 30 each: the placebo group received 0.1 ml/kg orange flavored juice, group 2 and 3 receiving 0.5 and 1 mg/kg of injectable midazolam mixed with an equal volume of orange juice, respectively. The main outcome measures included the mask acceptance, patients' behavioral scales and postoperative events. RESULTS: There were no significant differences in heart rate, respiratory rate, and systolic blood pressure among the three groups. However, arterial oxygen saturation was significantly reduced in those given 1 mg.kg-1 midazolam. The median scores of anxiety, separation from parent, preparing an intravenous line, acceptance of the oxygen mask, good sedation, crying reduction and consciousness level were better in midazolam group. Postoperative agitation and re-crying were also more frequent in placebo receivers. Those given 1 mg.kg-1 midazolam were significantly more optimal for sedation, crying, consciousness, preparing an intravenous line, and postoperative re-crying compared with 0.5 mg.kg-1 midazolam receivers. CONCLUSION: As a preanaesthetic medication, the 1 mg.kg-1 dose of orally given midazolam especially in a volume of orange juice and can optimize the children's behavior during skin laser treatment with no serious adverse effects, enhancing their parents' satisfactions about the sedative protocol.OBJETIVO:Investigar e comparar a eficácia do uso oral de midazolam com duas diferentes doses de suco de laranja na hemodinâmica peropeatória e mudanças de desempenho em crianças submetidas tratamento de pele por laser em Hospital educacional e acadêmico. MÉTODOS:Noventa crianças candidatas a

Medicina basada en la evidencia.

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José Félix Patiño Restrepo

1999-08-01

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El concepto de Medicina Basada en la Evidencia fue descrito en la Universidad de McMaster en el Canadá, como una nueva manera de enseñar y de practicar medicina. Pero fue en la Universidad de Oxford donde se hicieron los primeros planteamientos por el epidemiólogo Archie Cochrane, quien afirmó la necesidad de disponer de revisiones sistemáticas de los estudios prospectivos y randomizados en el campo de la atención medica. La Cochrane Collaboration, la Cochrane Network y la Cochrane Library constituyen una formidable organización internacional sin ánimo de lucro destinada a proveer información sistematizada sobre resultados de estudios prospectivos y controlados como fundamento para una atención de la salud de alta calidad.

La medicina basada en la evidencia integra la mejor evidencia científica disponible con la experiencia y la habilidad clínica, con el conocimiento de la fisiopatología y con las preferencias de los pacientes, para una toma de decisiones fundamentada en datos e información cuya veracidad y exactitud estén rigurosamente comprobados, o sea una práctica médica basada en los resultados de investigación científica de la mejor calidad. La mejor evidencia científica surge de ensayos prospectivos y rigurosamente controlados, los estudios clínicos randomizados* (ECR, que también se conocen como estudios clínicos controlados (ECC.

El concepto de medicina basada en la evidencia ha llevado al desarrollo de guías de práctica clínica, cuyo objetivo es objetivo es la estandarización de conductas a fin de minimizar variaciones en los patrones de la práctica médica, reducir la mala calidad de la atención, controlar diferencias geográficas en los patrones del ejercicio profesional y racionalizar costos. La Asociación Médica Americana prefiere la denominación “parámetros de práctica clínica”.

El concepto de medicina basada en la evidencia fue descrito en forma clásica en la

A reminiscence program intervention to improve the quality of life of long-term care residents with Alzheimer's disease: a randomized controlled trial Intervenção com um programa de reminiscência para melhorar qualidade de vida de residentes com Alzheimer com cuidados prolongados: ensaio controlado randomizado

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Daniel Jorge Luis Serrani Azcurra

2012-12-01

Full Text Available OBJECTIVE: A single-blinded, parallel-groups (intervention, active and passive control groups randomized controlled trial (RCT was chosen to investigate whether a specific reminiscence program is associated with higher levels of quality of life in nursing home residents with dementia. METHODS: The intervention used a life-story approach, while the control groups participated in casual discussions. The Social Engagement Scale (SES and Self Reported Quality of Life Scale (SRQoL were used as the outcome measures, which were examined at baseline (T0, 12 weeks (T1, and six months (T2 after the intervention. The final sample had 135 subjects (active control group = 45; passive control group = 45; intervention group = 45. RESULTS: The Wilcoxon test showed significant differences in the intervention group between T2 and T0, and between T1 and T0 in the SES, and there were significant differences between T0 and T1 (intervention effect size = 0.267 and T1 and T2 (intervention effect size = 0.450 in the SRQoL. The univariate logistic regression scores showed that predictors of change in the SRQoL were associated with fewer baseline anxiety symptoms and lower depression scores. CONCLUSIONS: The intervention led to significant differences between the three groups over time, showing a significant improvement in the quality of life and engagement of the residents in the intervention group.OBJETIVO: Elegeu-se um ensaio randomizado controlado simples cego, com grupos paralelos (intervenção, comparação e controle para pesquisar se um programa específico de reminiscência associa-se com maiores níveis de qualidade de vida em residentes com demência com cuidados prolongados. MÉTODO: No grupo de intervenção usou-se o enfoque da história de vida, enquanto o grupo controle recebeu conversas amistosas. A Escala de Compromisso Social (SES e a escala auto-referida de qualidade de vida (SRQoL foram as medidas de resultados, examinados na linha de base, doze

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. ...

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.

Tratamento farmacológico do transtorno bipolar: as evidências de ensaios clínicos randomizados Pharmacological treatment of bipolar disorder: evidence from randomized clinical trials

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Flávio Kapczinski

2005-01-01

Full Text Available O presente artigo é uma síntese das evidências provenientes de ensaios clínicos randomizados sobre o tratamento do transtorno bipolar. A metodologia para a busca do material disponível é descrita, e os resultados são apresentados. Com o melhor nível de evidência disponível, ou seja, revisões sistemáticas de mais de um ensaio clínico randomizado ou pelo menos um ensaio clínico randomizado, temos as seguintes recomendações: 1 a mania aguda pode ser tratada com Lítio, Valproato, Carbamazepina, e antipsicóticos; 2 a depressão bipolar pode ser tratada com antidepressivos (com risco aumentado de virada para mania, com lamotrigina e a associação fluoxetina/olanzapina e 3 a manutenção do transtorno bipolar pode ser realizada com o lítio, valproato, carbamazepina, olanzapina e lamotrigina (quando o objetivo for a profilaxia da depressão bipolar. A não existência de ensaios clínicos publicados não significa que determinadas intervenções não sejam úteis.The present article is a synthesis of the published clinical trials about the treatment of Bipolar disorder (BD. The methodology used to search the literature is described and results are presented. Using the best available evidence (systematic reviews of clinical trials or at lest one randomized clinical trial the following is recommended: 1 acute mania can be treated with lithium, carbamazepine, valrpoate and antipsychotics; 2 acute depression can be treated with lamotrigine, olanzapine/fluoxetine combination and with antidepressants (with an increased risk of switch into mania; 3 maintenance can be performed using lithium, valproate, olanzapine and lamotrigine (when the aim is prophylaxis of bipolar depression. The absence of published results about certain interventions does not mean that such interventions are not useful.

Efeito da suplementação de creatina, associada ou não ao treinamento de força, sobre a peroxidação lipídica em mulheres idosas

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Christiano Robles Rodrigues ALVES

2014-03-01

Full Text Available O objetivo desse trabalho foi avaliar o efeito da suplementação de creatina associada ou não ao treinamento de força sobre a peroxidação lipídica em mulheres idosas. Foi conduzido um estudo clínico, randomizado, duplo-cego e controlado por placebo, no qual mulheres idosas foram randomizadas para compor quatro grupos: 1 suplementação com placebo (PL; n = 10; 2 suplementação com creatina (CR; n = 10; 3 suplementação com placebo associado ao treinamento de força (PL+TR; n = 6; e 4 suplementação com creatina associado ao treinamento de força (CR+TR; n = 8. Antes (PRE e após 24 semanas (POS de intervenção, foram coletadas amostras de sangue para posterior análise das concentrações plasmáticas de hidroperóxidos lipídicos por espectrofotometria. Nenhuma diferença estatística foi observada na concentração de hidroperóxidos lipídicos entre os grupos (PL: PRE = 48,7 ± 36,9; POS = 29,3 ± 18,8; delta = -13,0 ± 26,8; CR: PRE = 51,0 ± 46,0; POS = 54,2 ± 51,6; delta = -8,6 ± 30,2; PL+TR: PRE = 33,0 ± 11,2; POS = 47,3 ± 31,6; Δ = 14,3 ± 39,2; CR+TR: PRE = 18,5 ± 10,1; POS = 28,1 ± 17,9; delta = 9,7 ± 16,4 pmol.mg-1 de proteína total; p = 0,17. A suplementação de creatina associada ou não ao treinamento de força não afetou a peroxidação lipídica, um importante marcador de estresse oxidativo no plasma, em mulheres idosas.

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.

Intervenções de enfermagem para o cuidado de pacientes com artrite: revisão integrativa da literatura

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Daniella Soares dos Santos

2012-12-01

Full Text Available Esta revisão integrativa buscou analisar a produção científica relacionada aos cuidados de enfermagem para pacientes com artrite. Foram incluídos 12 estudos experimentais, randomizados e controlados, publicados nas bases de dados CINAHL, MEDLINE, SciELO e LILACS, utilizando os descritores controlados "arthritis" e "nursing". Os resultados apontaram a efetividade de musicoterapia, estimulação elétrica neuromuscular, toque terapêutico e imagem guiada associada a relaxamento, para o tratamento da dor. Ser atendido por enfermeira especialista aumentou a satisfação com o atendimento, melhorou o impacto da doença e aumento a procura por serviços de saúde. Programas educativos específicos para portadores de artrite estimularam a prática de exercícios físicos e aqueles direcionados a pessoas com problemas crônicos em geral mostraram-se efetivos para controlar a dor e a incapacidade funcional. Concluímos que existe um conjunto de intervenções que podem subsidiar a prática de enfermagem baseada em evidências junto aos idosos com artrite.

Intervenções de enfermagem para o cuidado de pacientes com artrite: revisão integrativa da literatura

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Daniella Soares dos Santos

Full Text Available Esta revisão integrativa buscou analisar a produção científica relacionada aos cuidados de enfermagem para pacientes com artrite. Foram incluídos 12 estudos experimentais, randomizados e controlados, publicados nas bases de dados CINAHL, MEDLINE, SciELO e LILACS, utilizando os descritores controlados "arthritis" e "nursing". Os resultados apontaram a efetividade de musicoterapia, estimulação elétrica neuromuscular, toque terapêutico e imagem guiada associada a relaxamento, para o tratamento da dor. Ser atendido por enfermeira especialista aumentou a satisfação com o atendimento, melhorou o impacto da doença e aumento a procura por serviços de saúde. Programas educativos específicos para portadores de artrite estimularam a prática de exercícios físicos e aqueles direcionados a pessoas com problemas crônicos em geral mostraram-se efetivos para controlar a dor e a incapacidade funcional. Concluímos que existe um conjunto de intervenções que podem subsidiar a prática de enfermagem baseada em evidências junto aos idosos com artrite.

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.

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...

Hypnosis, hypnotizability, and placebo.

Science.gov (United States)

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.

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.

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

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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 �

[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.

Lung volume reduction surgery: an overview Cirurgia redutora de volume pulmonar: uma revisão

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Rodrigo Afonso da Silva Sardenberg

2010-01-01

úrgica. Os estudos analisados consistiram de randomizados controlados, estudos clínicos controlados, (randomizados e não randomizados, revisões e séries de casos. As questões acerca da validade através dos relatos iniciais, seguimentos incompletos, critérios de seleção indefinidos e análises de sobrevida confundiram a interpretação dos dados clínicos provenientes da CRVP. Pacientes com enfisema de predomínio em lobos superiores, inferiores e difuso, foram incluídos; também analisamos pontos chave, tais como morbidade e mortalidade peri-operatórias, assim como a medida da função pulmonar através do VEF 1. Enfisema do tipo bolhoso foi excluído desta revisão. Foram incluídas para análise também vias de acesso cirúrgico como esternotomia mediana, toracotomias unilateral ou bilateral e videotoracoscopia unilateral ou bilateral com grampeamento ou ablação por laser. Os resultados dos estudos prospectivos randomizados entre o tratamento clínico e a CRVP são essenciais para que alguma conclusão possa ser definitiva.

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

�-amilase e na pressão arterial, após uma aplicação de Reiki em enfermeiras que sofrem da síndrome de Burnout. Foi realizado ensaio clínico randomizado duplo-cego e placebo controlado, com desenho cruzado. Dezoito enfermeiras (idade entre 34 e 56 anos, com síndrome de Burnout, participaram do estudo. As participantes receberam tratamento com Reiki ou Reiki falso, de acordo com a ordem estabelecida, através da randomização em dois dias distintos. O teste de Anova mostrou interação significativa entre o momento da intervenção e a pressão arterial diastólica (F=4,92, p=0,04 e os níveis de sIgA (F=4,71, p=0,04. Conclui-se que uma sessão de Reiki de 30 minutos pode melhorar de forma imediata a resposta de IgAs e da pressão arterial diastólica em enfermeiras com síndrome de Burnout.

Falla cardiaca, tratamiento: diuréticos, inhibidores de la ECA y nitratos

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Guillermo Trout Guardiola

2013-10-01

Full Text Available En los pasados 15 años grandes ensayos clínicos randomizados, controlados, han revolucionado el manejo de pacientes con falla cardiaca. Aunque es claro que algunas drogas mejoran los síntomas, otras presentan beneficios pronósticos y sintomáticos, el manejo de falla cardiaca se debe centralizar en mejorar la calidad de vida y la sobrevida. Los diuréticos y los inhibidores de la enzima convertidora de la angiotensina, combinados con medidas no farmacologicas, permanecen como el tratamiento convencional para pacientes con falla cardiaca congestiva. La digoxina tiene una posible función en algunos de estos pacientes, sin embargo, el potencial beneficio de los betabloquedores y la espironolactona en falla cardiaca crónica han aumentado su reconocimiento.

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

Effects of auriculotherapy on labour pain: a randomized clinical trial.

Science.gov (United States)

Mafetoni, Reginaldo Roque; Shimo, Antonieta Keiko Kakuda

2016-01-01

Assessing the effects of auriculotherapy in pain control and its outcomes on the duration of labour. This is a randomized, controlled, double-blind trial with preliminary data. Thirty pregnant women with gestational age ≥ 37 weeks, cervical dilatation ≥ 4 cm and two or more contractions in 10 minutes were selected and randomly divided into three groups: auriculotherapy, placebo and control. Auriculotherapy was applied using crystal beads on four strategic points. No statistical significance was found between the groups with regard to pain; however, the women from the auriculotherapy group had lower intensity and less perception of pain at 30, 60 and 120 minutes of treatment. The average duration of labour was shorter in the auriculotherapy group (248.7 versus placebo 414.8 versus control 296.3 minutes); caesarean section rates were higher in the placebo group (50%) and the same in the other groups (10%). Mothers who received auriculotherapy presented a tendency for greater pain control and shorter labour duration; however, caesarean section rates in this group were similar to the control group. This trial precedes a larger study in progress. Registration of Brazilian Clinical Trials: RBR-47hhbj. Avaliar os efeitos da auriculoterapia no controle da dor e seus desfechos na duração do trabalho de parto. Trata-se de um ensaio controlado, randomizado e duplo-cego, com dados preliminares. Foram selecionadas 30 parturientes com idade gestacional ≥ 37 semanas, dilatação cervical ≥ 4 cm e duas ou mais contrações em 10 minutos, divididas aleatoriamente em três grupos: auriculoterapia, placebo ou controle. A auriculoterapia foi aplicada com microesferas de cristais em quatro pontos estratégicos. Não houve significância estatística entre os grupos com relação à dor; no entanto, as mulheres do grupo de auriculoterapia, apresentaram menor intensidade e menor percepção da dor aos 30, 60 e 120 minutos do tratamento. A média de duração do trabalho de

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.

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.

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.

Efficacy of auriculotherapy for the reduction of stress in nursing students: a randomized clinical trial Eficacia de la auriculoterapia para la disminución del estrés en estudiantes de enfermería: ensayo clínico aleatorio Eficácia da auriculoterapia para diminuição de estresse em estudantes de enfermagem: ensaio clínico randomizado

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Juliana Miyuki do Prado

2012-08-01

Full Text Available This study is a randomized single-blind trial, which aimed to evaluate the efficacy of true auriculotherapy and placebo auriculotherapy in reducing the stress levels of mid-level Nursing students of the School of Nursing of the Beneficência Portuguesa Hospital. Seventy-one students with average, high and very high scores, according to Vasconcellos' List of Stress Symptoms, were divided into three groups: Control (25, Auriculotherapy (24, and Placebo/Sham (22. They were evaluated at the baseline, 8th and 12th sessions and at the follow-up (15 days and received Shen Men and Brainstem points (Auriculotherapy Group and Wrist and Outer Ear points (Placebo/Sham Group. The analysis of variance (ANOVA showed statistically significant differences between the Control/Auriculotherapy groups from the 8th session, which was maintained in the third and fourth evaluations (p=0.000 and between the Control/Placebo groups (pEste ensayo clínico aleatorio simple-ciego tuvo el objetivo de evaluar la eficacia de la auriculoterapia verdadera y auriculoterapia placebo en la disminución del estrés de los estudiantes de la Escuela de Enfermería del Hospital Beneficência Portuguesa. Setenta y un alumnos com puntuaciones medias, altas y altísimas por la Lista de Síntomas de Estrés de Vasconcellos se dividieron en 3 grupos: Control (25, Auriculoterapia (24, Placebo/Sham (22. Se evaluaron al inicio, con 8, 12 sesiones y seguimiento (15 días. En la ANOVA se encontraron diferencias estadísticamente significativas entre os grupos de Control/Auriculoterapia en las 3 evaluaciones (P=0,000 y entre Control/Placebo (PTrata-se de estudo clínico randomizado, simples cego, com o objetivo de avaliar a eficácia da auriculoterapia verdadeira e placebo na diminuição dos níveis de estresse em alunos de nível médio, da Escola de Enfermagem do Hospital Beneficência Portuguesa. Setenta e um estudantes com escores médio, alto e altíssimo, pela Lista de Sintomas de Estresse

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.

Suplementação oral com picolinato de cromo em pacientes com diabetes tipo 2: um ensaio clínico randomizado

OpenAIRE

Paiva, Ana Nunes

2015-01-01

Diante da importância do papel do cromo no mecanismo da sensibilidade à insulina tem sido estudada a suplementação com este mineral em pacientes diabéticos. Assim, o objetivo deste estudo foi avaliar o efeito da suplementação oral com picolinato de cromo (PicCr) nas concentrações glicêmicas, lipidêmicas, perfil antioxidante e parâmetros antropométricos em pacientes com diabetes mellitus tipo 2 (DM2) mal controlados(hemoglobina glicada A1c (HbA1c) ≥ 7%). Para tanto, foi conduzido um ensaio clí...

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...

Effects of zinc supplementation on fatigue and quality of life in patients with colorectal cancer.

Science.gov (United States)

Ribeiro, Sofia Miranda de Figueiredo; Braga, Camila Bitu Moreno; Peria, Fernanda Maris; Martinez, Edson Zangiacomi; Rocha, José Joaquim Ribeiro da; Cunha, Selma Freire Carvalho

2017-01-01

To investigate the effects of oral zinc supplementation on fatigue intensity and quality of life of patients during chemotherapy for colorectal cancer. A prospective, randomized, double-blinded, placebo-controlled study was conducted with 24 patients on chemotherapy for colorectal adenocarcinoma in a tertiary care public hospital. The study patients received zinc capsules 35mg (Zinc Group, n=10) or placebo (Placebo Group, n=14) orally, twice daily (70mg/day), for 16 weeks, from the immediate postoperative period to the fourth chemotherapy cycle. Approximately 45 days after surgical resection of the tumor, all patients received a chemotherapeutic regimen. Before each of the four cycles of chemotherapy, the Functional Assessment of Chronic Illness Therapy-Fatigue scale was completed. We used a linear mixed model for longitudinal data for statistical analysis. The scores of quality of life and fatigue questionnaires were similar between the groups during the chemotherapy cycles. The Placebo Group presented worsening of quality of life and increased fatigue between the first and fourth cycles of chemotherapy, but there were no changes in the scores of quality of life or fatigue in the Zinc Group. Zinc supplementation prevented fatigue and maintained quality of life of patients with colorectal cancer on chemotherapy. Investigar os efeitos da suplementação oral de zinco sobre a intensidade da fadiga e a qualidade de vida de pacientes durante a quimioterapia para neoplasia colorretal. Estudo prospectivo, randomizado, controlado e duplo-cego conduzido em um hospital universitário público terciário, com 24 pacientes em regime quimioterápico para adenocarcinoma colorretal. Os pacientes receberam cápsulas de zinco 35mg (Grupo Zinco, n=10) ou placebo (Grupo Placebo, n=14) por via oral, duas vezes ao dia (70mg/dia), durante 16 semanas, desde o período pós-operatório imediato até o quarto ciclo de quimioterapia. Todos os pacientes receberam quimioterapia por

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

Consumption of red-hot chili pepper increases symptoms in patients with acute anal fissures. A prospective, randomized, placebo-controlled, double blind, crossover trial Efeito da pimenta vermelha nos sintomas de pacientes com fissuras anais agudas

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Pravin J. Gupta

2008-06-01

Full Text Available BACKGROUND: Red-hot chili pepper and other spices have been blamed for causing or exacerbating symptoms of anal pathologies like anal fissure and hemorrhoids. AIM: To determine if consumption of chilies increases symptoms of acute anal fissures. METHODS: Individual patients were randomized to receive capsules containing chili or placebo for one week in addition to analgesics and fiber supplement. Patients were asked to note score for symptoms like pain, anal burning, and pruritus during the study period. After 1 week, cross over treatment was administered to the same group of patients with the same methodology and results were noted at the end of 2 weeks. RESULTS: Fifty subjects were recruited for this study. Forty three of them completed the trial (22 in the chili group and 21 in the placebo group. The daily mean pain score was significantly lower in the placebo group in the study period. Score 2.05 in chili group and 0.97 in placebo group. There was a significant burning sensation experienced by the patients in the chili group (score 1.85 for the chili group vs 0.71 for the placebo group. Patient’s mean recorded improvement score was significantly higher after taking placebo. Eighty one point three percent patients preferred placebo while 13.9% preferred chilies. Two patients had no preference. CONCLUSION: Consumption of chili does increase the symptoms of acute anal fissure and reduces patient compliance.RACIONAL: A pimenta vermelha e outras especiarias têm sido responsabilizadas por agravar a sintomatologia das doenças anais, tais como fissuras e hemorróidas. OBJETIVO: Determinar se o consumo de pimentas vermelhas aumentaria os sintomas em fissuras anais agudas. MÉTODOS: Pacientes foram recrutados e randomizados para receber cápsulas contendo pimenta ou placebos por 1 semana, somadas a analgésicos e suplementos de fibras. Foi solicitado que anotassem um escore de sintomas, tais como dor, queimação anal, prurido durante o per

Eficácia da suplementação de ferro associado ou não à vitamina A no controle da anemia em escolares Efficacy of iron supplementation with or without vitamin A for anemia control

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Rute Cândida Pereira

2007-06-01

Full Text Available Com o objetivo de avaliar a eficácia da suplementação de ferro, associado ou não à vitamina A, na anemia ferropriva, administrado semanalmente, realizou-se ensaio clínico comunitário, randomizado, não controlado por placebo, em 1999. Uma amostra probabilística de 267 escolares de ambos os sexos com 6 a 14 anos de idade foram casualizados em bloco segundo dois tipos de intervenção: um grupo (144 recebeu 200mg de sulfato ferroso com (40mg de ferro elementar e o outro (123 recebeu dose similar de sulfato ferroso associado a 10.000 UI de vitamina A, durante 30 semanas. A prevalência de anemia ao final foi reduzida de 48,4%, para 17,7% (p This study aimed to evaluate the efficacy of weekly iron supplementation with or without vitamin A in the treatment of iron deficiency anemia, using an experimental, randomized, non-placebo-controlled design in 1999. 267 schoolchildren 6 to 14 years of age were randomized to two treatment groups: one group (144 received 200mg iron sulfate alone, with 40mg of elemental iron, while the other (123 received the same iron supplementation dose plus 10,000 IU of vitamin A (both groups for 30 weeks. Final anemia prevalence was reduced from 48.4% to 17.7% (p < 0.001 in the group receiving iron supplementation alone and 58.1% to 14.3% (p < 0.001 in the group receiving iron plus vitamin A. There was no significant difference between the groups at the end of the study according to mean Hb (p = 0.355 and anemia (p = 0.479. There was a significant correction for iron deficiency anemia with weekly iron-alone supplementation, but with no additional advantage of vitamin A. New studies on the synergism between these two micronutrients are recommended.

Radiation therapy for Graves' ophthalmopathy: a systematic review and meta-analysis of randomized controlled trials Radioterapia para oftalmopatia de Graves: uma revisão sistemática e meta-análise de ensaios clínicos randomizados e controlados

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Gustavo Arruda Viani

2012-10-01

ão sistemática e meta-análise de ensaios clínicos randomizados foram realizadas comparando RT 20 Gy, com ou sem glicocorticoides a tratamentos clinicos para a oftalmopatia de Graves. O MEDLINE, EMBASE, bases de dados da Biblioteca Cochrane e recentes de revistas relevantes foram pesquisados. Relatórios relevantes foram revisados por dois revisores. A resposta à radioterapia foi definida através do sucesso clinico de acordo a cada ensaio clínico. Nós também avaliamos a qualidade de vida e se a radioterapia produzia menos efeitos colaterais comparados a outras intervenções. RESULTADOS: Um total de 8 ensaios clínicos randomizados (439 pacientes foram identificados. Na análise de subgrupo, a resposta global para as taxas de tratamento foi melhor para: RT 20 Gy além de glicocorticoides vs glicocorticoides sozinhos, OR=17,5 (IC95% 1,85-250, p=0,04, RT 20 Gy vs sham RT, OR=3,15 (IC95% 1,59-6,23, p=0,003 e RT 20 Gy além de glicocorticoides por via intravenosa RT 20 Gy além de glicocorticoides orais, OR=4,15 (IC95% 1,34-12,87, p=0,01. Não houve diferenças entre RT 20 Gy contra outros fracionamentos e 20 Gy RT contra glicocorticoides sozinhos. RT 20 Gy, com ou sem glicocorticoides mostraram uma melhoria no grau de diplopia, acuidade visual, neuropatia óptica, abertura palpebral, proptose e da motilidade ocular. Não foi observada diferença para os custos, a pressão intraocular e a qualidade de vida. CONCLUSÃO: Nossos dados mostraram que 20 Gy RT deve ser oferecida como uma opção terapêutica válida para pacientes com moderada a severa oftalmopatia de Graves. A eficácia da radioterapia orbital pode ser aumentada pela interação sinérgica com os glicocorticoides. Além disso, RT 20 Gy é útil para melhorar vários sintomas oculares, excluindo a pressão intraocular, sem qualquer diferença de qualidade de vida.

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...

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...

Amigdalitis aguda recurrente bacteriana: Estudio prospectivo, comparativo y controlado de sus características clínicas y microbiológicas

OpenAIRE

Der M,Carolina; Iñiguez C,Rodrigo; Guzman D,Ana Maria; Jofré P,David; Iñiguez C,Armando; Labarca L,Jaime

2007-01-01

Introducción: La amigdalitis aguda recurrente es una patología de frecuente consulta, es una de las indicaciones de amigdalectomía. No se sabe con exactitud el origen de esta patología. Objetivo: Identificar la microbiología y patrones de susceptibilidad de las bacterias en la amigdalitis aguda recurrente bacteriana (AARB) a los antimicrobianos más comúnmente en el medio nacional, usados en su tratamiento. Material y método: Se planificó un estudio prospectivo, controlado y ciego. Se evaluaro...

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...

Magnitude da hipotensão pós-exercício aeróbio agudo: Uma revisão sistemática dos estudos randomizados

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Ana Cristina Oliveira Marques-Silvestre

2014-09-01

Full Text Available Objetivou-se revisar sistematicamente estudos randomizados sobre a magnitude da hipotensão pós-exercício (HPE em adultos. Consultaram-se as bases Pubmed, Scielo e Lilacs, combinando os indexadores “exercise” e “hypotension”, sendo encontrados 1336 estudos. Destes, excluíram-se 1268 por títulos, 37 por resumos, 10 não randomizados, 1 por repetição de dados, restando 20. Estes foram avaliados segundo os itens de randomização, mascaramento, sigilo de alocação, análise por intenção de tratar e quantitativamente pela Escala de Jadad. As reduções das pressões sistólica (PAS e diastólica (PAD em normotensos foram inferiores à dos hipertensos (−9±3 vs −11±6 mmHg e −5±2 vs −8±6 mmHg, respetivamente. Em ambos os grupos, os indivíduos ativos apresentaram HPE maior que os sedentários (normotensos: PAS −10±4 vs −8±1 mmHg; PAD −5±1 vs −4±1 mmHg; hipertensos: PAS −16±4 vs −9±2 mmHg; PAD −7±4 vs −5±3 mmHg, respetivamente. Nestes estudos, a magnitude da HPE variou entre −4 a −19 mmHg para PAS e −2 a −9 mmHg para PAD, valores que dependem tanto das características da amostra, seus estágios pressóricos iniciais, sexo e nível de atividade física, como também do protocolo de exercício utilizado, não havendo consenso sobre a influência da sua duração ou da intensidade do exercício.

Comparison of nail lacquer clobetasol efficacy at 0,05%, 1% and 8% in nail psoriasis treatment: prospective, controlled and randomized pilot study Comparação da eficácia do clobetasol em esmalte 0,05%, 1% e 8% no tratamento da psoríase ungueal: estudo piloto, prospectivo, controlado e randomizado

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Robertha Carvalho Nakamura

2012-04-01

com resultados insatisfatórios causados pela ineficiência da penetração da substância ativa através da placa ungueal e dobra proximal. Recentemente tem sido proposto o uso do clobetasol em veículo esmalte, demonstrando resultados satisfatórios e ausência de efeitos colaterais. OBJETIVO: Determinar a eficácia e segurança do clobetasol em veículo esmalte em três concentrações (0,05%, 1% e 8% nos pacientes com psoríase ungueal. MÉTODOS: Estudo piloto, prospectivo, controlado e randomizado com quinze pacientes portadores de psoríase ungueal em ambas as mãos. Os pacientes foram subdivididos em três grupos: A (esmalte clobetasol 0,05%, B (esmalte de clobetasol 1% e C (esmalte de clobetasol 8%. Os pacientes usaram esmalte de clobetasol na mão esquerda e esmalte base (sem medicação - controle na direita, aplicandoos duas vezes por semana, por 16 semanas. Fez-se a avaliação clínica por registros fotográficos e pelos MÉTODOS: NAPSI da mão tratada e controle e NAPSI modificado da unha mais acometida da mão tratada. RESULTADOS: O grupo C apresentou de forma estatisticamente significativa a resposta clínica mais relevante, refletida na melhora dos parâmetros clínicos, do NAPSI da mão tratada comparado ao da mão controle e do NAPSI modificado da unha mais acometida da mão tratada. CONCLUSÕES: Neste estudo piloto, o esmalte de clobetasol a 8% foi eficaz e seguro, mostrando-se uma boa opção de terapêutica tópica no tratamento da psoríase ungueal.

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.

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.

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.

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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.

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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.

Semiotics and the placebo effect.

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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.

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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.

Acupuncture, psyche and the placebo response.

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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.

Differential effectiveness of placebo treatments

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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.

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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.

Importance of placebo effect in cough clinical trials.

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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.

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.

N-acetylcysteine for major depressive episodes in bipolar disorder N-acetilcisteína para o tratamento de episódios de depressão maior no transtorno bipolar

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Pedro V Magalhães

2011-12-01

Full Text Available OBJECTIVE: In this report, we aimed to evaluate the effect of add-on N-acetylcysteine (NAC on depressive symptoms and functional outcomes in bipolar disorder. To that end, we conducted a secondary analysis of all patients meeting full criteria for a depressive episode in a placebo controlled trial of adjunctive NAC for bipolar disorder. METHOD: Twenty-four week randomised clinical trial comparing adjunctive NAC and placebo in individuals with bipolar disorder experiencing major depressive episodes. Symptomatic and functional outcome data were collected over the study period. RESULTS: Seventeen participants were available for this report. Very large effect sizes in favor of NAC were found for depressive symptoms and functional outcomes at endpoint. Eight of the ten participants on NAC had a treatment response at endpoint; the same was true for only one of the seven participants allocated to placebo. DISCUSSION: These results indicate that adjunctive NAC may be useful for major depressive episodes in bipolar disorder. Further studies designed to confirm this hypothesis are necessary.OBJETIVO: Neste relato, avaliamos o efeito da N-acetilcisteína (NAC adjuvante em sintomas depressivos e desfechos funcionais no transtorno bipolar. Para isso, conduzimos uma análise secundária de todos os pacientes com critérios diagnósticos para um episódio depressivo em um ensaio clínico randomizado comparando NAC adjuvante com placebo no transtorno bipolar. MÉTODO: Ensaio clínico randomizado comparando NAC adjuvante com placebo para episódios depressivos no transtorno bipolar durante 24 semanas. Desfechos funcionais e sintomáticos foram coletados no período. RESULTADOS: Dezessete participantes estavam disponíveis para esta análise. Tamanhos de efeito grandes foram encontrados para sintomas depressivos e desfechos funcionais. Oito dos dez participantes no grupo da NAC tiveram resposta clínica ao fim do tratamento. O mesmo ocorreu em apenas um dos sete

Placebo Trends across the Border: US versus Canada

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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

Brief motivational interview and educational brochure in emergency room settings for adolescents and young adults with alcohol-related problems: a randomized single-blind clinical trial Intervenção motivacional breve e brochura educacional em pronto-socorro para adolescentes e adultos jovens com problemas relacionados ao álcool: um ensaio clínico simples-cego randomizado

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Maria Luiza Segatto

2011-09-01

foi utilizado para analisar a diferença entre os grupos de intervenção, com nível de significância estatística α = 5% e intervalo de confiança (IC de 95%. RESULTADOS: 186 indivíduos formaram a amostra inicial, sendo n = 175 incluídos e randomizados para brochura educativa (n = 88 ou grupo entrevista motivacional breve (n = 87. O seguimento de avaliação foi realizado em 85,2% da amostra. Não foi observada diferença significativa entre os grupos. No entanto, uma redução significativa (p < 0,01 em problemas relacionados eo abuso de álcool foram encontrados em ambos os grupos. CONCLUSÃO: Nesta amostra, a redução do abuso de álcool e problemas relacionados foi observada. Dados preliminares indicam que os ensaios clínicos controlados com entrevista motivacional breve, brochura educativa e não-intervenção deveriam ser de futuro interesse entre a população adolescente brasileira.

Brief motivational interview and educational brochure in emergency room settings for adolescents and young adults with alcohol related problems: a randomized single blind clinical trial Intervenção motivacional breve e brochura educacional em pronto-socorro para adolescentes e adultos jovens com problemas relacionados ao álcool: um ensaio clínico simples cego randomizado

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Maria Luiza Segatto

2011-01-01

para analisar a diferença entre os grupos de intervenção, com nível de significância estatística α = 5% e intervalo de confiança (IC 95%. RESULTADOS: 186 indivíduos formaram a amostra inicial, sendo n =175 incluídos e randomizados para brochura educativa (n = 88 ou grupo entrevista motivacional breve (n = 87. O seguimento de avaliação foi realizado em 85,2% da amostra. Não foi observada diferença significativa entre os grupos. No entanto, uma redução significativa (p < 0,01 em problemas relacionados eo abuso de álcool foram encontrados em ambos os grupos. CONCLUSÃO: Nesta amostra, a redução do abuso de álcool e problemas relacionados foi observada. Dados preliminares indicam que os ensaios clínicos controlados com entrevista motivacional breve, brochura educativa e não-intervenção deveriam ser de futuro interesse entre a população adolescente brasileira.

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

Antibioticoprofilaxia com ampicilina na rotura prematura das membranas: estudo randomizado e duplo cego Ampicillin prophylaxis in premature rupture of membranes: randomized and double-blind study

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José Elias Soares da Rocha

1999-06-01

Full Text Available Objetivos: avaliar se o uso profilático da ampicilina pode evitar ou reduzir a morbidade infecciosa materna e perinatal decorrente da ruptura prematura das membranas (RPM e prolongar a gestação em pacientes portadoras dessa complicação. Métodos: estudo prospectivo, randomizado e duplo-cego, avaliando 121 gestantes portadoras de RPM, divididas em dois grupos. O grupo tratado (61 gestantes recebeu ampicilina e o grupo controle (60 gestantes recebeu placebo, nas mesmas condições de horário, tempo de uso, embalagem e cor das cápsulas. Como parâmetros de infecção materna considerou-se a morbidade febril materna (índice térmico, presença de corioamnionite e/ou endometrite. Os parâmetros neonatais avaliados foram o índice de Apgar (1° e 5° minutos, colonização bacteriana do conduto auditivo e hemocultura. Para a análise estatística foram utilizados os testes: exato de Fisher, Wilcoxon e o chi². Resultados: o uso da ampicilina não prolongou a gestação, não reduziu a morbidade febril puerperal e nem as taxas de corioamnionite e/ou endometrite. Quanto à morbidade infecciosa perinatal também não foi possível demonstrar nenhuma redução decorrente do uso da ampicilina nem influência sobre as condições de nascimento. Estes dados foram consistentes em casos de RPM com até 72 horas de evolução, pois o limitado número de casos com tempo maior de evolução não permitiu uma análise estatística isenta de erro tipo II. Conclusões: com base nos resultados desse trabalho foi possível concluir que o uso profilático de ampicilina em gestantes com RPM com até 72 horas de evolução não reduz a morbidade infecciosa materna nem perinatal. No entanto, a presença de Streptococcus agalactiae do grupo B em hemocultura de recém-nascido do grupo controle indicou a necessidade imperiosa de antibioticoterapia para as gestantes colonizadas por esse microrganismo.Purpose: to evaluate whether prophylactic use of ampicillin could

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.

Efeito do uso profilático do anti-inflamatório não-esteroide ibuprofeno sobre o desempenho em uma sessão de treino de força Effects of prophylactic anti-inflammatory non-steroidal ibuprofen on performance in a session of strength training

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Cleiton Silva Correa

2013-04-01

Full Text Available INTRODUÇÃO: Medicamentos anti-inflamatórios não esteroides, como o ibuprofeno, têm sido utilizados por atletas de várias modalidades com o intuito de aumentar desempenho esportivo. OBJETIVO: Verificar o efeito do uso profilático de ibuprofeno sobre desempenho em uma sessão de treino de força. MÉTODOS: Um ensaio clínico, cruzado, randomizado, duplo-cego e placebo-controlado foi desenvolvido com 12 praticantes regulares de treino de força do sexo masculino, os quais realizaram uma sessão de treino após a ingestão de ibuprofeno (1,2 g e uma outra após a ingestão de placebo. Seis séries dos exercícios supino e agachamento foram realizadas em cada sessão de treino com uma carga constante correspondente a 65% da 1RM de cada exercício. O desempenho no treinamento foi mensurado através do número de repetições que os voluntários conseguiram realizar em cada série de exercício a cada sessão de treino de força. RESULTADOS: Não foram verificadas diferenças significativas de desempenho no treino de força com a administração prévia de placebo ou ibuprofeno (p > 0,05. CONCLUSÃO: A ingestão de ibuprofeno nos parâmetros de administração adotados pelo presente estudo não promove qualquer tipo de alteração na tolerância ao exercício em uma sessão isolada de treino de força, o que contraria a indicação dessa substância para fins ergogênicos no treino de força.INTRODUCTION: Non-steroidal anti-inflammatory drugs, such as ibuprofen, have been used by athletes of several sports modalities in order to increase athletic performance. OBJECTIVE: To verify the effect of the prophylactic use of ibuprofen on performance in a strength training session. METHODS: A crossover, randomized, double-blind and placebo-controlled clinical assay was developed with twelve male regular practitioners of strength training who performed one strength training session after ibuprofen (1.2 g ingestion and another session after placebo

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.

Otimização hemodinâmica em trauma grave: uma revisão sistemática e metanálise

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Carlos Corredor

2014-12-01

Full Text Available Objetivo: O trauma grave pode associar-se a ocorrência de importante choque hemorrágico e ao comprometimento da perfusão dos órgãos. Formulamos a hipótese de que o tratamento direcionado por objetivo conferiria benefícios em termos de morbidade e mortalidade, em casos graves de trauma. Métodos: Realizamos uma busca sistemática nas bases de dados MedLine, Embase e Cochrane Controlled Clinical Trials Register com relação a pacientes vítimas de trauma grave. A mortalidade foi o desfecho primário dessa revisão. Os desfechos secundários incluíram taxas de complicações, duração da permanência no hospital e na unidade de terapia intensiva, e o volume de fluidos administrados. A metanálise foi realizada utilizando o programa de computador RevMan, e os dados apresentados são as odds ratios (OR para desfechos dicotomizados e as diferenças médias e diferenças médias padrão para desfechos contínuos. Resultados: Foram analisados quatro estudos clínicos randomizados e controlados, que incluíram 419 pacientes. O risco de mortalidade foi significantemente reduzido nos pacientes com tratamento direcionado por objetivo, em comparação ao grupo controle (OR=0,56; IC95%: 0,34-0,92. A duração da permanência na unidade de terapia intensiva (DM: 3,7 dias; IC95%: 1,06-6,5 e no hospital (DM: 3,5 dias; IC95%: 2,75-4,25 foi significantemente mais curta no grupo de pacientes do grupo tratado conforme o protocolo. Não houve diferenças nos relatos relativos a volume total de fluidos infundidos e a transfusões sanguíneas. A heterogeneidade nos relatos entre os estudos impediu uma análise quantitativa das complicações. Conclusão: Após a ocorrência de trauma grave, o uso precoce de tratamento direcionado por objetivo se associou com mortalidade mais baixa e com menos dias de permanência na unidade de terapia intensiva e no hospital. Os achados desta análise devem ser interpretados com cautela, em razão da importante

Effect of intervention programs in schools to reduce screen time: a meta‐analysis

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Roberta Roggia Friedrich

2014-05-01

Full Text Available Objective: to evaluate the effects of intervention program strategies on the time spent on activities such as watching television, playing videogames, and using the computer among schoolchildren. Sources: a search for randomized controlled trials available in the literature was performed in the following electronic databases: PubMed, Lilacs, Embase, Scopus, Web of Science, and Cochrane Library using the following Keywords randomized controlled trial, intervention studies, sedentary lifestyle, screen time, and school. A summary measure based on the standardized mean difference was used with a 95% confidence interval. Data synthesis: a total of 1,552 studies were identified, of which 16 were included in the meta‐analysis. The interventions in the randomized controlled trials (n = 8,785 showed a significant effect in reducing screen time, with a standardized mean difference (random effect of: −0.25 (−0.37, −0.13, p < 0.01. Conclusion: interventions have demonstrated the positive effects of the decrease of screen time among schoolchildren. Resumo: Objetivo: avaliar os efeitos das estratégias dos programas de intervenção sobre o tempo dedicado a atividades como assistir à televisão, jogar videogame e usar computador em escolares. Fonte dos dados: foi realizada busca de estudos controlados randomizados, disponíveis nas bases de dados eletrônicas PubMed, Lilacs, Embase, Scopus, Web of Science e Cochrane Library, com os descritores: randomized controlled trial, intervention studies, sedentary lifestyle, screen time e school. Medida de sumário baseada na diferença das médias padronizadas foi usada com intervalo de confiança de 95%. Síntese dos dados: foram identificados 1.552 estudos, dos quais 16 foram incluídos na meta‐análise. As intervenções nos estudos controlados randomizados (n = 8.785 apresentaram efeito significativo na redução do tempo em frente à tela, com diferença das médias padronizadas (efeito rand

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

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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?

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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.

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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

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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.

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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.

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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.

Mechanisms of the placebo response in pain in osteoarthritis.

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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.

Tofacitinib or Adalimumab versus Placebo for Psoriatic Arthritis.

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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

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.

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.

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.

Trimetazidina e resposta inflamatória em cirurgia de revascularização do miocárdio Trimetazidine and inflammatory response in coronary artery bypass grafting

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Gerez Fernandes Martins

2012-08-01

Full Text Available FUNDAMENTO: A resposta inflamatória orgânica constitui um mecanismo fisiopatológico presente em todas as cirurgias de revascularização do miocárdio com circulação extracorpórea (CRVM-CEC, e a liberação de mediadores inflamatórios constitui um de seus mecanismos de defesa. OBJETIVO: Avaliar, em estudo prospectivo duplo-cego randomizado e controlado com placebo, os efeitos da trimetazidina (Tmz sobre a resposta inflamatória, por meio da variação nas interleucinas 6 e 8; TNF-α; complementos C3 e C5, e na proteína C reativa ultrassensível (PCR-us, em dois momentos, pré e pós-operatório. MÉTODOS: Foram estudados 30 pacientes submetidos a CRVM-CEC utilizando cardioplegia hipotérmica intermitente, e com no máximo disfunção ventricular leve, divididos em dois grupos (placebo e Tmz, estratificados por ecocardiografia e recebendo medicação/placebo na dose de 60mg/dia. As amostras foram dosadas no pré-operatório sem medicação, no dia da cirurgia com 12 a 15 dias de medicação/placebo e, seguidamente, 5 min após o desclampeamento aórtico, 12 e 24h, para interleucinas e complementos, e 48h para PCR. RESULTADOS: Não ocorreram diferenças significativas entre os níveis de interleucina 8, Tnf-α, complementos C3 e C5, e PCR-us. No entanto, no grupo tratado, os níveis de interleucina 6 foram significativamente inferiores aos do grupo controle, em todos os momentos analisados. CONCLUSÃO: A trimetazidina mostrou-se eficaz apenas na redução da interleucina 6 nos pacientes submetidos à CRVM.BACKGROUND: Organic inflammatory response is a pathophysiological mechanism present at every coronary artery bypass grafting with extracorporeal circulation (CABG-ECC, the release of inflammatory mediators being one of its defense mechanisms. OBJECTIVE: To assess, in a prospective double-blind randomized and placebo-controlled study, the effects of trimetazidine (Tmz on the inflammatory response, by using the variation in interleukins 6

Uso de clorexidina 2% gel e escovação mecânica na higiene bucal de pacientes sob ventilação mecânica: efeitos na pneumonia associada a ventilador The use of 2% chlorhexidine gel and toothbrushing for oral hygiene of patients receiving mechanical ventilation: effects on ventilator-associated pneumonia

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Maria Cristina de Avila Meinberg

2012-12-01

Full Text Available OBJETIVO: Avaliar os efeitos da higiene bucal com clorexidina 2% e escovação mecânica sobre a taxa de pneumonia associada a ventilador em uma população mista de pacientes sob ventilação mecânica prolongada. MÉTODOS: Estudo piloto prospectivo, aleatório e placebo-controlado. Foram incluídos pacientes sob ventilação mecânica, com menos de 24 horas de internação e cuja perspectiva de duração da ventilação mecânica era a de um período >72 horas. Os pacientes foram randomizados para o grupo clorexidina (gel com clorexidina a 2% e escovação mecânica ou grupo placebo (gel da mesma coloração e consistência e escovação mecânica na higiene bucal. RESULTADOS: A análise interina planejada foi realizada quando 52 pacientes foram incluídos, e o estudo foi interrompido precocemente. Um total de 28 pacientes foi incluído no grupo clorexidina/escovação mecânica e 24 no grupo placebo. As taxas de pneumonia associada a ventilador foram de 45,8% no grupo placebo e de 64,3% no grupo clorexidine/escovação mecânica (RR=1,4; IC95%=0,83-2,34;p=0,29. CONCLUSÃO: Devido a interrupção precoce por futilidade, não foi possível avaliar o impacto do uso de clorexidina a 2% e escovação mecânica na higiene bucal na incidência de pneumonia associada a ventilador nessa população heterogênea de pacientes críticos sob ventilação mecânica prolongada, não tendo sido evidenciado nenhum efeito benéfico dessa intervenção.OBJECTIVE: To evaluate the effects of oral chlorhexidine hygiene with toothbrushing on the rate of ventilator-associated pneumonia in a mixed population of critically ill patients under prolonged mechanical ventilation. METHODS: Prospective, randomized, and placebo-controlled pilot study. Patients who were receiving mechanical ventilation, had been admitted less than 24 hours prior, and were anticipated to require mechanical ventilation for more than 72 hours were included in the study. The patients were randomly

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

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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.

Suicide risk in placebo-controlled studies of major depression

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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.

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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.

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.

Analgesia preemptiva com dipirona versus ibuprofeno na fotocoagulação a laser da retina

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Artur Macaferri Del Santo

2016-02-01

Full Text Available RESUMO Objetivo: Comparar a efetividade da dipirona versus o ibuprofeno para a redução da dor na fotocoagulação da retina (FR. Método: Foi realizado um estudo controlado, duplo cego e randomizado englobando trinta e quatro pacientes com retinopatia diabética separados em dois grupos. Grupo A recebeu 1000mg de dipirona e o grupo B recebeu 600mg de ibuprofeno. A dor foi avaliada pela escala visual analógica. Resultado: A média do escore da dor nos grupos A e B foi de 5,2 ± 2.6 e 4,5 ± 1,4, respectivamente. Não houve diferença estatística entre os grupos (p=0,34. O mesmo foi observado quanto à analise entre dor leve, moderada e grave (p=0,09. Os grupos foram semelhantes quanto à idade e sexo. Conclusão: Os medicamentos foram equivalentes ou equipotentes em reduzir a dor ocular durante a fotocoagulação a laser da retina.

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.

Alterações gastrointestinais em pacientes com câncer colorretal em ensaio clínico com fungos Agaricus sylvaticus Gastrointestinal alterations in patients with colorectal cancer on clinical trial supplemented with Agaricus sylvaticus fungus

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Renata Costa Fortes

2010-03-01

Full Text Available INTRODUÇÃO: Fungos medicinais podem normalizar a função intestinal, aumentar o apetite e reduzir os efeitos adversos do tratamento convencional do câncer. OBJETIVO: Avaliar as alterações gastrointestinais de pacientes com câncer colorretal em fase pós-operatória após suplementação dietética com fungos Agaricus sylvaticus. METODOLOGIA: Ensaio clínico randomizado, duplo-cego, placebo-controlado, realizado no Hospital de Base do Distrito Federal. Amostra constituída de 56 pacientes (24 homens e 32 mulheres, estádios I, II e III, seguindo determinados critérios de inclusão e exclusão, separados em grupos placebo e Agaricus sylvaticus (30mg/kg/dia e acompanhados por um período de seis meses. Para avaliar as alterações gastrointestinais foram utilizados um formulário-padrão e uma anamnese dirigida-padrão. O método de análise dos resultados foi qualitativo e descritivo, utilizando os programas Microsoft Excel 2003 e Epi Info 2004 para Windows, versão 3.3.2. RESULTADOS: Após seis meses de tratamento, observou-se, no grupo Agaricus sylvaticus, aumento do apetite e redução da constipação, diarréia, diarréia alternada com constipação, flatulência, retenção de flatos, pirose, plenitude pós-prandial, náuseas, distensão e dor abdominais, fatos não observados no grupo placebo. CONCLUSÃO: Os resultados sugerem que a suplementação dietética com fungos Agaricus sylvaticus é capaz de melhorar as alterações gastrointestinais de pacientes no pós-operatório de câncer colorretal, promovendo melhoria na qualidade de vida desses pacientes.INTRODUCTION: Medicinal fungus may normalize intestinal function, increase appetite and reduce adverse effects caused by conventional cancer treatment. OBJECTIVE: To evaluate the gastrointestinal alterations of patients with colorectal cancer in post-operative phase after dietary supplementation with Agaricus sylvaticus fungus. METHODOLOGY: Randomized, double-blind, placebo

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.

[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

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.

Energyhealing and the placebo-effect

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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.

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Samuel Oliveira de Afonseca

2013-03-01

incidência dessa neuropatia em 50%. Este estudo teve como objetivo avaliar a efetividade da vitamina E na prevenção da NP induzida pela oxaliplatina.TIPO DE ESTUDO E LOCALEstudo piloto prospectivo e randomizado de fase II desenvolvido em hospital universitário do Grande ABC.MÉTODOSOs pacientes foram randomizados para receber vitamina E ou placebo por cinco dias antes do início do tratamento com oxaliplatina e até o término do regime quimioterápico. O desfecho foi avaliado através dos Critérios Comuns de Toxicidade do Câncer versão 3 (CTCAE e escalas específicas de gradação da NP induzida por oxaliplatina. Foram incluídos pacientes com câncer colorretal e gástrico programado para receber quimioterapia baseada em oxaliplatina. Ambos os grupos receberam suplementação de cálcio e magnésio antes e depois das infusões de oxaliplatina.RESULTADOSDezoito pacientes foram randomizados para grupo da vitamina E e 16 para o grupo placebo. Observou-se incidência cumulativa de 83% das classes I/II de neuropatia periférica no grupo da vitamina E, contra 68% no grupo placebo (P = 0,45. Observou-se maior tendência à diarreia em pacientes que receberam vitamina E (55,6% versus 18,8%, P = 0,06. Não houve outras diferenças significativas quanto às toxicidades entre os grupos.CONCLUSÃONão foi demonstrada diminuição significativa na incidência de NP aguda induzida por oxaliplatina com o uso de vitamina E.REGISTRO DE ENSAIO CLÍNICONCT01523574.

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

Effects of Abexol® (beeswax alcohols) in patients with gastric symptoms

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Julio César Fernández-Travieso; Iván Rodríguez-Cortina; José Illnait-Ferrer; Lilia Fernández-Dorta; Rosa Mas-Ferreiro; Yohaní Pérez-Guerra; Rafael Gámez-Menéndez; Meilis Mesa-Angarica; Sonia Jiménez-Despaigne; Sarahí Mendoza-Castaño; Dalmer Ruiz-Mas

2012-01-01

Estudios experimentales y clínicos han demostrado que el tratamiento oral con Abexol® (previamente D-002), mezcla de seis alcoholes alifáticos superiores purificada de la cera de abejas, produce efectos gastroprotectores y antioxidantes. Bajos niveles plasmáticos de vitamina C han sido reportados en sujetos que sufren de gastritis crónica con respecto a voluntarios sanos. El presente estudio aleatorizado, a doble ciegas, controlado con placebo tuvo como objetivo investigar los efectos del Abe...

Reactogenicidad de la vacuna cubana trivalente contra la leptospirosis humana en un ensayo clínico de fase II

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Raydel Martínez,; Alberto Pérez; Alberto Baly; Morelia Baró; Reynaldo Menéndez; Aroldo Ruíz; Amelia Urbino López; Manuel Díaz; Marlene Armesto

2001-01-01

Con el objetivo de evaluar la reactogenicidad de la vacuna cubana trivalente contra la leptospirosis humana (vax- SPIRAL) en grupos de voluntarios sanos utilizando diferentes dosis, se realizó un ensayo clínico controlado, aleatorio y a doble ciego. Los voluntarios fueron distribuidos en dos grupos (vacunados y placebos) para evaluar las reacciones adversas en diferentes concentraciones de dosis (0,25 y 0,5 mL). Los síntomas y signos locales evaluados fueron: dolor, rubor, infiltración local,...

Uso do Verapamil em Gestantes Hipertensas Crônicas: análise do Fluxo das Artérias Uterinas e Umbilical Use of Verapamil in Chronic Hypertensive Pregnant Women: flow Analysis of Uterine Arteries and Umbilical Artery

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Marcus Jose do Amaral Vasconcellos

2000-06-01

Full Text Available Objetivo: este trabalho, utilizando verapamil, um bloqueador dos canais lentos de cálcio, constituiu ensaio clínico randomizado, duplo-cego e placebo controlado, e objetivou procurar variação do fluxo uteroplacentário e fetoplacentário durante uso oral crônico do fármaco em gestantes com hipertensão crônica leve para moderada. Métodos: 123 pacientes divididas em dois grupos: grupo estudo (n = 61, submetidas a 240 mg/dia de verapamil, e grupo controle (n = 62, submetidas ao placebo. As pacientes randomizadas em grupos de quatro utilizaram a medicação ou placebo durante trinta dias. Um exame do fluxo das artérias uterinas e da artéria umbilical pela dopplervelocimetria foi registrado. Pelo cálculo da média e desvio padrão, foram comparados os valores dos índices de resistência (IR e pulsatilidade (IP e da relação sístole/diástole (A/B das artérias em estudo após administração dos comprimidos. Resultados: o grupo verapamil apresentou os seguintes valores médios para as artérias uterinas: IR = 0,82 (0,28, IP de 1,06 (0,12 e A/B de 2,42 (0,51. O grupo placebo mostrou: IR de 0,75 (0,35, IP de 1,00 (0,18 e A/B de 2,30 (0,38. Quando analisada a artéria umbilical, os valores foram para o grupo verapamil: IR = 0,73 (0,12, IP = 1,04 (0,13 e A/B = 2,94 (0,32. No grupo placebo, IR = 0,70 (0,14, IP = 1,03 (0,07 e A/B = 3,02 (0,78. A análise estatística das diferenças das médias por meio da razão F mostrou não haver diferença entre os dois grupos avaliados. Conclusão: este trabalho referenda o uso do verapamil entre gestantes com hipertensão crônica (leve para moderada, pois não oferece prejuízos no fluxo uteroplacentário e fetoplacentário.Purpose: this study, using verapamil, a slow calcium channel blocker, was a randomized, clinical, double blind and placebo controlled trial, whose objective was to observe if there was a uteroplacental and fetoplacental flow variation during its chronic oral use. Methods: 123

A brief history of placebos and clinical trials in psychiatry.

Science.gov (United States)

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

NARCIS (Netherlands)

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

Effectiveness of an educational program in nursing in the self-care of patients with heart failure: randomized controlled trial Efectividad de un programa educativo en enfermería en el autocuidado de los pacientes con insuficiencia cardíaca: ensayo clínico controlado Efetividade de um programa educativo em enfermagem no autocuidado em pacientes com insuficiência cardíaca: ensaio clínico randomizado

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María de los Ángeles Rodríguez-Gázquez

2012-04-01

Full Text Available Unblinded randomized controlled clinical trial to evaluate the effectiveness of an educational program in nursing (educational meetings, home visits, telenursing and a printed book in the improvement of self-care behaviors in patients with heart failure was evaluated. Thirty-three people participated in the intervention group and thirty in the control group. At the beginning and at the end of the study (ninth month, Nancy Artinian's Heart Failure Self-care Behaviors Scale was applied to assess the level of self-care. 66.0% of the intervention group versus 26.6% of the control group improved the self-care score by at least 20% (pEnsayo clínico controlado aleatorizado sin cegamiento, con el que se evaluó la efectividad de un programa educativo de enfermería (encuentros educativos, visitas domiciliarias, tele enfermería y cartilla impresa en el mejoramiento de los comportamientos de autocuidado en pacientes con insuficiencia cardíaca. Participaron 33 personas en el grupo de estudio y 30 en el grupo control. Al inicio y al finalizar el estudio (noveno mes se aplicó la Escala de Comportamientos de Autocuidado de Pacientes con Insuficiencia cardiaca de Nancy Artinian para evaluar el nivel de autocuidado. Resultados: 66,0% del grupo de intervención versus 26,6% del grupo control mejoraron en al menos un 20% el puntaje de autocuidado (pTrata-se de ensaio clínico controlado, aleatorizado, sem cegamento, no qual se avaliou a efetividade de um programa educativo de enfermagem (encontros educativos, visitas domiciliárias, tele-enfermagem e cartilha impressa, no melhoramento dos comportamentos de autocuidado em pacientes com insuficiência cardíaca. Participaram 33 pessoas no grupo de estudo e 30 no grupo controle. No início e no final do estudo (nono mês, aplicou-se a Escala de Comportamentos de Autocuidado de Pacientes com insuficiência cardíaca, de Nancy Artinian, para avaliar o nível de autocuidado. Resultados: 66,0% do grupo de interven

Eficácia da avaliação audiométrica no tratamento medicamentoso da otospongiose The effectiveness of audiometric evaluation in drug treatment for otospongiosis

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Andy de Oliveira Vicente

2012-04-01

Full Text Available A otospongiose é uma osteodistrofia focal primária da cápsula ótica que acomete indivíduos geneticamente predispostos e promove perda auditiva progressiva. OBJETIVO: Verificar a aplicabilidade da avaliação audiométrica no tratamento medicamentoso da otospongiose. MATERIAL E MÉTODO: Estudo prospectivo, randomizado, controlado, duplo-cego, envolvendo 26 pacientes com diagnóstico clínico, audiométrico e tomográfico de otospongiose. Os pacientes elegíveis para o estudo foram alocados em três grupos (A, B e C e receberam o tratamento com alendronato de sódio (B, fluoreto de sódio (C e placebo (A por 6 meses. Após este período, os mesmos realizaram nova avaliação audiométrica. RESULTADOS: Na análise das diferenças entre as vias aérea e óssea (gap, não houve diferença estatisticamente significante. Também não foram encontradas diferenças em relação ao limiar de reconhecimento da fala (SRT e a discriminação vocal (IRF entre os períodos pré e pós-tratamento. CONCLUSÃO: Após seis meses de tratamento medicamentoso, a avaliação audiométrica evidenciou manutenção dos limiares auditivos, sugerindo estabilização da atividade da lesão otospongiótica.Otospongiosis is a primary osteodystrophy of the otic capsule that affects genetically predisposed individuals and leads to a progressive hearing loss. AIM: To evaluate the applicability of audiometric evaluation during drug treatment for otospongiosis. MATERIALS AND METHODS: A prospective, randomized, controlled, double-blind study involving 26 patients with clinical, audiometric and CT scan image of otosclerosis. Patients eligible for the study were divided into three groups (A, B and C and received treatment with alendronate sodium (B, sodium fluoride (C and placebo (A for 6 months. After this period they were submitted to new tests. RESULTS: There were not statistically significant differences between air and bone conduction (gap. We also found no differences in

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.

Attitudes Toward Placebo Use in Lebanon.

Science.gov (United States)

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.

Science.gov (United States)

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

Science.gov (United States)

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

Efectividad de la profilaxis analgésica con clonixinato de lisina en exodoncias: ensayo clínico aleatorio.

OpenAIRE

Pedro Aravena; Bruna Benso; Alejandra Bertín; Rocío Aravena-Torres

2013-01-01

RESUMEN Objetivo: Evaluar la efectividad de la profilaxis analgésica con dosis únicas de clonixinato de lisina (CL 125mg) en pacientes sometidos a extracciones dentales. Metodología: Ensayo clínico aleatorio, doble enmascaramiento placebo-controlado. Participaron pacientes ASA I y II con indicación de exodoncia dental de servicios públicos en la ciudad de Valdivia-Chile en el mes de octubre del 2012. Se asignó de manera aleatoria dos grupos: un grupo tratamiento quienes recibieron una dosis ...

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?

Science.gov (United States)

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.

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.

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.

Science.gov (United States)

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.

Science.gov (United States)

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

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

Science.gov (United States)

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.

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.

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.

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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

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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.

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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.

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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.

Sellado de lesiones de caries dental no cavitadas: ensayo clínico aleatorio controlado

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Jesús Alberto-Luengo-Fereira

2013-07-01

Full Text Available Objetivo: Evaluar la efectividad del sellado de lesiones de caries dental no cavitadas. Materiales y Métodos: Se realizó un ensayo clínico, aleatorio, doble ciego, controlado y diseño de boca dividida. Fueron seleccionados 262 primeros molares permanentes, en 74 niños con edad media de 7,47±0.8 años. Cada paciente tenía mínimo un par de primeros molares permanentes con lesiones bilaterales de caries dental códigos 1, 2 o 3 del Sistema Internacional de Detección y Valoración de Caries Dental. Se asignaron aleatoriamente a tres tipos de tratamiento, 1: vidrio ionomérico (3M ESPE Ketac Molar Easymix®, 2: Sellante resinoso (3M ESPE Climpro®, 3: vidrio ionomérico modificado con resina (3M ESPE Ketac® N100. La retención y progresión de caries dental fueron evaluadas. Los datos se procesaron con el programa SPSS V15. Se utilizaron las pruebas Chi Cuadrado y Test de Fisher. Resultados: La tasa retención total de los tratamientos 1, 2 y 3 fue respectivamente: 51,7%, 43,4% y 26,4%; no obstante estas diferencias no fueron significativas. La incidencia de caries en los molares no sellados fue 31,8% y en los molares sellados con perdida completa del material 28,5%. No se encontraron diferencias significativas en la progresión de las lesiones entre molares que reciben y los que no reciben tratamiento. Conclusiones: En este estudio, no se encontraron evidencias de diferencias en la retención y en la progresión de las lesiones selladas y no selladas, entre el vidrio ionomérico convencional de alta densidad, el sellante a base de resina y un vidrio ionomérico modificado con resina.

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

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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

Efeito Agudo da Pressao Positiva Continua sobre a Pressao de Pulso na Insuficiencia Cardiaca Cronica

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Monica Quintao

2014-03-01

Full Text Available Fundamento: Pacientes com insuficiência cardíaca (IC apresentam disfunção ventricular esquerda e redução da pressão arterial média (PAM. O aumento do estímulo adrenérgico causa vasoconstrição e resistência dos vasos, mantendo a PAM, enquanto aumenta a resistência vascular periférica e a rigidez dos vasos condutores. O aumento da pressão de pulso (PP reflete a complexa interação do coração com os sistemas arteriais e venosos. O aumento da PP é um importante marcador de risco em pacientes com insuficiência cardíaca crônica (ICC. A ventilação não invasiva (VNI tem sido utilizada para IC aguda descompensada para melhorar a congestão e a ventilação pelos efeitos respiratórios e hemodinâmicos. No entanto, nenhum desses estudos relatou o efeito da VNI na PP. Objetivo: O objetivo deste estudo foi determinar os efeitos agudos da VNI com CPAP (pressão positiva contínua nas vias aéreas sobre a PP em pacientes ambulatoriais com ICC. Métodos: Seguindo um protocolo randomizado, duplo-cego, cruzado e controlado com placebo, 23 pacientes com ICC (17 homens, 60 ± 11 anos, IMC 29 ± 5 kg/cm2, classes II e III da NYHA foram submetidos à CPAP via máscara nasal durante 30 minutos na posição reclinada. A pressão da máscara foi de 6 cmH2O, enquanto o placebo foi fixado em 0-1 cmH2O. PP e outras variáveis hemodinâmicas não invasivas foram avaliadas antes, durante e depois do placebo e do modo CPAP. Resultados: A CPAP diminuiu a frequência cardíaca de repouso (pré: 72 ± 9; pós 5 min: 67 ± 10 bpm , p < 0,01 e PAM (CPAP: 87 ± 11; controle 96 ± 11 mmHg , p < 0,05 pós 5 min. A CPAP diminuiu a PP (CPAP: 47 ± 20 pré para 38 ± 19 mmHg pós; controle: 42 ± 12 mmHg, pré para 41 ± 18 pós p < 0,05 pós 5 min. Conclusão: A VNI com CPAP diminuiu a pressão de pulso em pacientes com ICC estável. Ensaios clínicos futuros devem investigar se esse efeito está associado com melhora no desfecho clínico.

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

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.

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.

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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.

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.

Science.gov (United States)

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.

Treinamento de atenção e memória em pacientes com esquizofrenia estáveis: um estudo randomizado, controlado, duplo-cego

OpenAIRE

Livia Maria Martins Pontes

2011-01-01

INTRODUÇÃO: Portadores de esquizofrenia podem apresentar déficits cognitivos proeminentes, especialmente nos campos da atenção, memória e funções executivas. Este trabalho teve a finalidade de propor e investigar um programa de treino cognitivo da atenção e memória de baixo custo, realizado em grupos, para pacientes brasileiros com esquizofrenia. MÉTODOS: Cinqüenta e sete pacientes ambulatoriais de duas instituições de saúde mental, de ambos os sexos, com idades entre 18 e 50 anos, que preenc...

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.

Implante de Stent guiado por ultrassom intracoronariano melhora desfechos: meta-análise de ensaios randomizados

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Graciele Sbruzzi

2012-01-01

Full Text Available FUNDAMENTO: Ultrassom Intracoronariano (USIC tem sido usado como um método auxiliar a fim de otimizar o implante de stents. No entanto, o impacto desse método em alguns resultados é controverso. OBJETIVO: Analisar sistematicamente o impacto dos stents coronarianos guiados por USIC, em comparação com os stents guiados angiograficamente, sobre os resultados clínicos e angiográficos. MÉTODOS: Foi realizada uma busca em bases de dados (MEDLINE, Cochrane CENTRAL, EMBASE e referências de estudos publicados entre 1982 e 2010. Foram incluídos Ensaios Clínicos Randomizados (ECR que compararam o implante de stents coronarianos guiados por angiografia e USIC versus implante de stents coronarianos guiados apenas por angiografia (ANGIO. O seguimento mínimo foi de seis meses e os resultados avaliados foram eventos cardíacos adversos importantes (MACE, Revascularização da Lesão-alvo (RLA e reestenose angiográfica. Dois revisores extraíram os dados de forma independente. Razão de risco sumário e intervalos de confiança de 95% (CI foram calculados com modelos com efeitos aleatórios. A abordagem GRADE foi utilizada para determinar a qualidade geral de evidências para cada resultado. RESULTADOS: Dos 3.631 artigos identificados, oito ECR avaliando um total de 2.341 pacientes foram incluídos. Houve uma redução de 27% na reestenose angiográfica (95% IC: 3% -46% e uma redução de 38% em RLA (95% IC: 17% -53% em favor de USIC versus ANGIO. No entanto, os MACE não foram reduzidos por USIC (RR: 0,79; 95%CI: 0,61-1,03. Os dados MACE representam apenas 47% do tamanho ótimo de informações necessárias para detectar com segurança um efeito de tratamento plausível. CONCLUSÕES: Observamos que o implante de stent coronariano guiado por USIC oferece reduções significativas em RLA e reestenose angiográfica em comparação com implante de stent guiado por angiografia, porém não reduz casos de MACE.

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.

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.

Study of repeated transcranial magnetic stimulation on the treatment of cocaine addiction

OpenAIRE

Philip Leite Ribeiro

2012-01-01

INTRODUÇÃO: dependência de cocaína é um problema grave de saúde no Brasil e no mundo. Até hoje não existe um tratamento específico eficaz para este sindrome. A Estimulação Magnética Transcraniana de repetição(EMTr) é um método capaz de neuromodular o cérebro. MÉTODOS: Em um estudo randomizado duplo cego 25 pacientes dependentes de cocaína com diagnóstico feito pelo DSM IV-TR foram tratados em condição de EMTr de alta freqüência ativa (1250 pulsos/dia) ou EMTr placebo.O tratamento consiste em ...

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

Science.gov (United States)

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.

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

DEFF Research Database (Denmark)

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

Science.gov (United States)

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.

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

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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.

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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

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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…

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

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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.

Estetoscópio digital como ferramenta inovadora no ensino da ausculta cardíaca

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Claudio Tinoco Mesquita

2013-02-01

Full Text Available O exame físico cardiovascular, em particular a ausculta cardíaca, é uma das habilidades clínicas mais difíceis para os alunos durante seu treinamento médico. Estudos sugerem que o uso de tecnologias, como o estetoscópio digital, aumente a acurácia do exame clínico, entretanto, seu impacto no ensino da propedêutica da ausculta cardíaca em alunos de graduação de Medicina não é conhecido. O objetivo é demonstrar a utilidade do estetoscópio digital, em comparação com métodos tradicionais, como instrumento de ensino da ausculta cardíaca. Estudo de intervenção, longitudinal, controlado, unicêntrico e randomizado. Foram inscritos 38 alunos de medicina para um curso de semiologia cardiovascular com duração de oito semanas. Definiu-se um programa com aulas expositivas e à beira do leito nas enfermarias de Cardiologia. Nas aulas práticas, os alunos foram randomizados em dois grupos: 1 (n = 21 estetoscópio digital (Littmann® modelo 3200, 3M; e 2 (n = 17 estetoscópios convencionais. Foi realizada uma avaliação pré-treinamento, através de um teste utilizando o software Heart Sounds®, que foi repetida ao final do curso. As médias das avaliações foram comparadas pelo teste T pareado e não pareado. Observa-se que, ao final do curso, houve uma melhora significativamente maior no grupo que utilizou o estetoscópio digital (51,9% quando comparado ao grupo que utilizou o estetoscópio convencional (29,5%. Intervenções de curta duração para o ensino de semiologia cardíaca são capazes de contribuir de modo significativo para melhora da proficiência da identificação dos sons cardíacos. O uso do estetoscópio digital demonstrou ser um fator positivo no ensino dessas habilidades.

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

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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...

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

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

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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.

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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.

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 ...

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.

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...

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

Science.gov (United States)

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.

Evaluation of flurazepam and placebo on sleep disorders in childhood

OpenAIRE

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.

Science.gov (United States)

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.

Science.gov (United States)

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.

Science.gov (United States)

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.

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.

Science.gov (United States)

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...

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

Emprego da nimodipina (oxigen como protetor cerebral na cirurgia de revascularização do miocárdio com circulação extracorpórea em pacientes idosos Use of nimodipine for cerebral injury prophylaxis in surgical myocardial revascularization with extracorporeal circulation in elderly patients

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Ricardo Manrique

1996-12-01

Full Text Available Aproximadamente 5% dos pacientes submetidos a cirurgia cardíaca com auxílio da circulação extracorpórea apresentaram problemas neurológicos. Avaliando funções neuropsíquicas, as alterações atingem de 50% a 70% dos casos. Os idosos são mais vulneráveis; nestes, a freqüência de acidente vascular cerebral (AVC aproxima-se dos 9%. Considerando que a população envelhece a um ritmo acelerado e que 0 coronariopata freqüentemente passa dos 65 anos de idade, é fundamental pesquisar meios profiláticos para diminuir esta incidência. Este é um estudo piloto, duplo cego, randomizado e controlado com 64 pacientes, 30 no Grupo nimodipina e 34 no Grupo placebo. As variáveis demográficas e diagnosticas pré-operatórias foram homogêneas, com exceção da incidência de isquemia cerebral transitória. O Grupo nimodipina, mesmo com programação cirúrgica e evolução intra e pós-operatória mais complicadas, apresentou menor número de casos neurológicos. No Grupo nimodipina foram constatados 3 casos de confusão mental e, no Grupo placebo, além de 3 casos de confusão mental, foram diagnosticados mais 2 casos de sonolência e 1 AVC isquêmico com seqüela. No total, foram 3 (10% casos em 30 pacientes no Grupo nimodipina, e 6 (17,64% em 34 pacientes no Grupo placebo, caracterizando uma redução de 76,4%. LEGAULT et al. (15 relatam uma elevada mortalidade de pacientes em uso de nimodipina, quando operados para troca valvar, causada, principalmente, por hemorragia. Nós não encontramos esta correlação. A mortalidade hospitalar é similar em ambos os grupos (1 paciente em cada e o sangramento não é estatisticamente diferente (1 caso de hemorragia importante no Grupo nimodipina. No seguimento até 41 meses, a mortalidade no Grupo placebo foi maior (4 pacientes que no Grupo nimodipina (1 paciente.Around 5 percent of the patients submitted to heart surgery with extracorporeal circulation present neurological problems. In relation to

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.

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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.

Efectividad de la premedicación con N-acetil cisteína más dimetilpolisiloxano versus un placebo para mejorar la visibilidad en la endoscopia digestiva: estudio prospectivo, ciego, controlado aleatorizado

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Martín Alonso Gómez-Zuleta

2017-06-01

Full Text Available Introducción: el cáncer gástrico es el tumor maligno que genera mayor mortalidad en Colombia. Para su tratamiento es fundamental detectarlo en un estadio temprano de desarrollo. Infortunadamente en Colombia, más del 90 % de los casos se diagnostican en estado avanzado a diferencia de Japón donde menos del 50 % tienen esta característica. Esto se debe a que, en ese país, se practican endoscopias (EVDA de tamización y porque todas se preparan con una solución que permite limpiar el moco y la saliva. Objetivo: evaluar si la preparación con una solución antes de la EVDA permite mejorar la visibilidad del estómago. Diseño: se trata de un estudio prospectivo, ciego controlado y aleatorio, que se realizó entre enero y junio de 2016. Métodos: los pacientes provenientes de consulta externa y a quienes se les realizó endoscopia EVDA fueron asignados al azar en dos grupos. Al Grupo A, se le administraron 100 ml de agua mezclada con 400 mg de N-acetil cisteína (NAC y 200 mg (3 cm3, solución a 66 mg/cm3 de dimetilpolisiloxano (DMPS media hora antes del examen; mientras que al Grupo B, solo se le administraron 100 ml de agua media hora antes. Todas las soluciones se prepararon en frascos tapados para que ni el paciente, ni el médico vieran el contenido. Después de la endoscopia, se evaluó la preparación en una escala visual previamente validada y se compararon los resultados obtenidos en los dos grupos. Resultados: En total, se incluyeron 203 pacientes con un promedio de edad de 57 años de los cuales el 62,2 % eran mujeres. El Grupo A estaba integrado por 98 pacientes y el Grupo B, por 105. No se presentaron diferencias significativas en cuanto a edad o sexo en ninguno de los dos grupos. Al evaluar la visibilidad de la mucosa se detecta que el Índice de visibilidad total (IVT fue de 4,8 ± 2,2 en el Grupo A versus 7,4 ± 2,9 en el Grupo B, con una p<0,00. En cuanto a los hallazgos endoscópicos, se encontró que: en tres pacientes del

Incontinência urinária no puerpério de parto vaginal e cesárea: revisão de literatura = Urinary incontinence in postpartum of vaginal delivery and cesarean: literature review

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Borba, Alice Rios

2014-01-01

Full Text Available Objetivo: O estudo objetivou revisar a literatura quanto à presença de incontinência urinária (IU no puerpério de parto normal e cesárea. Materiais e Métodos: Foi realizada uma pesquisa nos bancos de dados PubMed/MedLine, COCHRANE e EMBASE. Foram selecionados os seguintes tipos de estudo: prospectivo multicêntrico, caso-controle, prospectivo, coorte, multicêntrico prospectivo observacional, randomizado controlado, prospectivo observacional, coorte controlado, transversal, base populacional, publicados no período de 2002 a 2012, nos idiomas inglês e português, em que as palavras-chave estivessem no título ou resumo. As palavras-chave utilizadas foram: “parto vaginal”, “cesárea” e “incontinência urinária”. Resultados: Os 14 estudos analisados, avaliaram a presença de IU no puerpério de parto vaginal e cesárea. Observamos que a cesárea para ter seu papel protetor no aparecimento da IU no puerpério deve ser realizada de maneira eletiva. Os distúrbios do assoalho pélvico estão fortemente ligados com idade materna, fumo, obesidade, parto de fórceps, multiparidade, episiotomia, duração da segunda fase do trabalho de parto, gravidez e constipação crônica. Conclusão: Conclui-se que a segunda fase prolongada do trabalho de parto tem papel significativo na presença da IU no puerpério em ambos modos de parto, e que a cesárea teria o seu valor protetor no desenvolvimento da IU no puerpério apenas se fosse realizada de maneira eletiva. Dos 14 artigos, apenas um estudo foi realizado na população brasileira, mostrando a importância de serem realizados mais estudos sobre IU no puerpério no Brasil

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

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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.

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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.

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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

Utilizando as abordagens quantitativa e qualitativa na produção do conhecimento Utilizando los abordajes cuantitativo y cualitativo en la producción del conocimiento Using quantitative and qualitative approaches in knowledge production

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Odaléa Maria Brüggemann

2008-09-01

Full Text Available O debate sobre as diferenças entre os métodos quantitativo e qualitativo é freqüente, havendo posições favoráveis e contrárias acerca da sua integração. Delinear uma pesquisa que contemple as duas abordagens gera dúvidas e inquietações sobre como utilizá-las sem ferir o rigor dos métodos, a especificidade, a sofisticação metodológica e reflexiva de cada uma delas. O objetivo é relatar e discutir a utilização da abordagem quantitativa (ensaio clínico controlado randomizado e qualitativa para avaliar e compreender a inserção do acompanhante de escolha da mulher durante o trabalho de parto/parto, desempenhando o papel de provedor de apoio. A utilização das duas abordagens possibilitou aproximar as múltiplas facetas envolvidas nessa prática e avaliá-la tanto na dimensão explicativa quanto na compreensiva, uma vez que pôde ser realizada com olhares complementares.El debate sobre las diferencias entre los métodos cuantitativo y cualitativo es frecuente, existiendo posiciones favorables y contrarias respecto a su integración. Delinear una investigación que contemple los dos abordajes genera dudas e inquietudes en relación a cómo utilizarlos sin herir el rigor de los métodos, la especificidad, la sofisticación metodológica y reflexiva de cada uno de ellos. El objetivo es relatar y discutir la utilización del abordaje cuantitativo (ensayo clínico controlado randomizado y cualitativo, para evaluar y comprender la inserción del acompañante elegido por la mujer durante el trabajo de parto y el parto, desempeñando el papel de proveedor de apoyo. La utilización de los dos abordajes hizo posible la aproximación de las múltiples facetas involucradas en esta práctica, así como evaluarlas tanto en la dimensión explicativa como en la comprensiva, debido a que puede ser realizada con visiones complementarias.The debate over the differences between quantitative and qualitative methods is frequent, holding favorable

Reprocessamento e reutilização de material odonto-médico-hospitalar de uso único: busca de evidências pela revisão sistemática de literatura científica Reprocesamiento y reutilización de material odontológico- médico y hospitalario de uso único. Búsqueda de evidencias por la revisión sistemática de literatura científica Re-sterilization and re-utilization of single use of dental and medical devices: a systematic review of the literature

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Carla Patrícia Amaral Carvalho Denser

2006-09-01

Full Text Available OBJETIVOS: busca de evidências científicas que suportem ou não a prática de re-processamento e reutilização de artigos odonto-médico-hospitalares originalmente de uso único. MÉTODOS: estudo de revisão sistemática realizado em 2004, por meio da análise de vinte publicações de pesquisas básicas e uma revisão sobre esta temática, a qual considerou seus escopos, tipos de investigação, testes realizados e resultados. RESULTADOS: apesar da maioria delas constituiu-se estudos experimentais controlados, apenas três eram randomizados. Constatou-se grande variedade de artigos investigados, escopos, métodos de re-processamento empregados e testes realizados, o que contribuiu para resultados divergentes. CONCLUSÃO: conclui-se que tal prática não pode ser realizada indiscriminadamente, com base no conhecimento atual, sendo imperioso considerar cada caso, validando protocolos de re-processamento e reuso baseados em conhecimento científico com níveis de evidência bem estabelecidos.OBJETIVOS: búsqueda de evidencias científicas que soporten o no la práctica de reprocesamiento y reutilización de artículos odontológicos-médicos y hospitalarios originalmente de uso único. MÉTODOS: estudio de revisión sistemática realizado en el 2004, por medio del análisis de veinte publicaciones de investigaciones básicas y una revisión sobre esta temática, la cual consideró sus esquemas, tipos de investigación, tests realizados y resultados. RESULTADO: a pesar de que la mayoría de ellas constituyan estudios experimentales controlados, apenas tres eran randomizados. Se constató gran variedad de artículos investigados, esquemas, métodos de reprocesamiento empleados y tests realizados, lo que contribuyó a que existan resultados divergentes. CONCLUSIÓN: se concluye que tal práctica no puede ser realizada indiscriminadamente, con base en el conocimiento actual, siendo imperioso considerar cada caso, validando protocolos de

Preservação da veia safena magna na cirurgia de varizes dos membros inferiores Varicose vein surgery in lower limbs with preservation of the great saphenous vein

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Hamilton Almeida Rollo

2009-06-01

Full Text Available A veia safena magna autóloga é o melhor substituto arterial nas revascularizações dos membros inferiores, importante na revascularização do miocárdio e pode ser utilizada nas cirurgias do sistema venoso e nos traumas das extremidades. A fleboextração aumenta os riscos de lesões linfáticas e neurológicas. Assim, no tratamento das varizes primárias dos membros inferiores por meio da cirurgia ou de outras técnicas, a preservação da safena é recomendável se ela for normal ou apresentar alterações que ainda permitam sua preservação pela correção da causa desencadeante. Tal correção pode ser feita por técnicas cirúrgicas. Entre elas, a cura hemodinâmica da insuficiência venosa em ambulatório (CHIVA tem mostrado bons resultados. Recentemente, um ensaio clínico randomizado e controlado foi publicado comprovando sua eficácia. Outra técnica bastante utilizada é a da ligadura rasante da junção safenofemoral + crossectomia + ligadura das tributárias de crossa, com a qual se tem obtido resultados contraditórios. Finalmente, as técnicas que corrigem a insuficiência da safena reparando as valvas ostial e pré-ostial (valvoplastia externa são mais fisiológicas. Um ensaio clínico internacional multicêntrico, randomizado e controlado, testando um novo dispositivo, está sendo realizado, com resultados iniciais favoráveis. Este estudo pretende fazer uma revisão sobre as técnicas utilizadas na preservação da safena magna.The autologous great saphenous vein is the most effective bypass choice for lower limb revascularization, playing an important role in myocardial revascularization, and can be used in venous system surgeries and extremity traumas. Stripping increases the risk of lymphatic lesions and nerve damage. Therefore, when surgery or other techniques are used to treat primary varicose veins in the lower limbs, preservation of the saphenous vein is a desirable objective whenever the vein remains healthy or

Sinais vitais e expressão facial de pacientes em estado de coma Signos vitales y expresión facial de pacientes en estado de coma Vital signs and facial expression of patients in coma

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Ana Cláudia Giesbrecht Puggina

2009-06-01

Full Text Available O objetivo foi verificar a influência da música e mensagem oral sobre os Sinais Vitais e Expressão Facial dos pacientes em coma fisiológico ou induzido. Realizou-se um Ensaio Clínico Controlado e Randomizado. A amostra consistiu-se de 30 pacientes de Unidade de Terapia Intensiva, que foram divididos em 2 grupos: Grupo Controle (sem estímulos auditivos e Grupo Experimental (com estímulos auditivos. Os pacientes foram submetidos a 3 sessões, em dias consecutivos. Encontraram-se alterações estatisticamente significativas nos sinais vitais (saturação de O2 - sessão 1; saturação de O2 - sessão 3; freqüência respiratória - sessão 3 durante a mensagem e na expressão facial, sessão 1, durante a música e a mensagem. Aparentemente a mensagem foi um estímulo mais forte do que a música em relação à capacidade de produzir respostas fisiológicas sugestivas de audição.El objetivo era verificar la influencia de la música y del mensaje verbal en los Señales Vitales y la Expresión Facial de los pacientes en coma fisiológico o inducido. Un Ensayo Clínico Controlado y Randomizado fue echo. La muestra fue consistida en 30 pacientes de Unidad de terapia Intensiva, que fueran divididos en 2 grupos: Grupo Control (sin estímulos auditivos y Grupo Experimental (con los estímulos auditivos. Los pacientes fueran sometidos a las 3 sesiones, en días consecutivos. Los cambios estadísticamente significativos en las Señales Vitales fueran encuentrados (saturación del oxigeno - sesión 1; saturación del oxigeno - sesión 3; frecuencia respiratoria - sesión 3 durante el mensaje y en la Expresión Facial, sesión 1, durante música y el mensaje. Aparentemente el mensaje era uno estimulo más fuerte de qué la música en lo que refiere a la capacidad de producir respuestas fisiológicas de audición.The objective was to check music and voice message influence on the Vital Signals and Facial Expressions of patients in physiological or

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.

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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.

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.

Suplementação de ácidos graxos ômega 3 em atletas de competição: impacto nos mediadores bioquímicos relacionados com o metabolismo lipídico Adición de ácidos grasos omega 3 en atletas de competición: impacto en los mediadores bioquímicos relacionados con el metabolismo lipídico Omega 3 fatty acids-supplementation to competition athletes: impact on the biochemical indicators related to the lipid metabolism

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Priscila de Mattos Machado Andrade

2006-12-01

Full Text Available OBJETIVO: Avaliar o efeito da suplementação dos ácidos graxos ômega 3 em atletas de natação sobre indicadores bioquímicos. MÉTODOS: Nadadores de elite (n = 14 do sexo masculino foram avaliados em estudo randomizado, controlado por placebo pelo período de seis semanas (45 dias. O grupo placebo (GP recebeu óleo mineral (n = 6 e o grupo suplementado (n = 8, óleo de peixe (GOP contendo, no total, 950mg de ácido eicosapentaenóico e 500mg de ácido docosapentaenóico. Amostras de sangue foram coletadas imediatamente antes (T0, aos 15 (T15, aos 30 (T30 e aos 45 (T45 dias de suplementação para análise da composição dos ácidos graxos por cromatografia gasosa e para quantificação das lipoproteínas plasmáticas através de kits comerciais específicos. RESULTADOS: Os resultados revelaram um desajuste na dieta dos atletas considerando a ingestão g/kg de massa corporal dos macronutrientes. A análise do questionário de freqüência de consumo mostrou que os atletas não ingeriram regularmente fontes alimentares de ômega 3 e que o consumo de peixes, em 85% da amostra, era inferior ou igual a uma vez na semana. O perfil de ácidos graxos plasmáticos evidenciou aumento dos ácidos graxos poliinsaturados ômega 3 (P 0,05. CONCLUSÃO: A suplementação de ácidos graxos N-3 em atletas nadadores altera os indicadores bioquímicos do metabolismo lipídico, influenciando na redução das lipoproteínas plasmáticas, ricas em colesterol e na prevenção de doenças cardiovasculares.OBJETIVO: Evaluar el efecto suplementar de los ácidos grasos omega 3 en atletas de natación sobre indicadores bioquímicos. MÉTODOS: Nadadores de elite (n = 14 del sexo masculino fueron evaluados en estudio aleatorio, controlado por placebo por un período de 6 semanas (45 días. El grupo placebo (GP recibió aceite mineral (n = 6 y el grupo suplementado (n = 8 recibió aceite de pescado (GOP conteniendo en total 950 mg de ácido eicosapentaenóico y 500 mg de

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.

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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.

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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.

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.

Segurança, imunogenicidade e eficácia protetora de duas doses da vacina RIX4414 contendo rotavírus atenuado de origem humana Safety, immunogenicity, and protective efficacy of two doses of RIX4414 live attenuated human rotavirus vaccine in healthy Brazilian infants

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Eliete C. Araujo

2007-06-01

Full Text Available OBJETIVO: Determinar a segurança, imunogenicidade e eficácia de duas doses da vacina contra o rotavírus em lactentes brasileiros saudáveis. MÉTODOS: Foi realizado um estudo randomizado, multicêntrico, duplo-cego e controlado por placebo no Brasil, México e Venezuela. Os lactentes receberam duas doses orais de vacina ou placebo aos 2 e 4 meses de idade, juntamente com as imunizações de rotina, exceto a vacina oral contra poliomielite (VOP. O presente estudo relata apenas os resultados obtidos em Belém, Brasil, onde o número de indivíduos por grupo e os títulos da vacina viral foram os seguintes: 194 (104,7 unidades formadoras de focos - UFF, 196 (10(5,2 UFF, 194 (10(5,8 UFF e 194 (placebo. A resposta de anticorpos anti-rotavírus (anti-RV foi avaliada em 307 indivíduos. A gravidade clínica dos episódios de gastroenterite (GE foi determinada através de um escore com 20 pontos, onde um valor > 11 foi considerado como GE grave. RESULTADOS: As taxas de sintomas gerais solicitados foram semelhantes tanto nos indivíduos que receberam a vacina como naqueles a quem se administrou placebo. Aos 2 meses após a segunda dose, ocorreu resposta em termos de IgA sérica para RV em 54,7 a 74,4% dos vacinados. Não houve interferência na imunogenicidade das vacinas de rotina. A eficácia da vacina contra qualquer gastroenterite por rotavírus (GERV foi de 63,5% (IC95% 20,8-84,4 para a maior concentração (10(5,8 UFF. A eficácia foi de 81,5% (IC95% 44,5-95,4 contra GERV grave. Em sua maior concentração (10(5,8 UFF, a RIX4414 conferiu uma proteção de 79,8% (IC95% 26,4-96,3 contra GERV grave causada pela amostra G9. CONCLUSÕES: A RIX4414 foi altamente imunogênica com baixa reatogenicidade, e não interferiu na resposta sérica à difteria, tétano, coqueluche, hepatite B e antígenos Hib. Duas doses da RIX4414 conferiram proteção significativa contra a GE grave causada pelo RV.OBJECTIVE: To determine the safety, immunogenicity and

Análise dos efeitos da cinesioterapia e da hidrocinesioterapia sobre a qualidade de vida de pacientes com fibromialgia: um ensaio clínico randomizado

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Celina Dani Hecker

Full Text Available OBJETIVO: Verificar e comparar os efeitos da hidrocinesioterapia e da cinesioterapia na qualidade de vida de pacientes portadoras de fibromialgia. MATERIAIS E MÉTODOS: Foi realizado um ensaio clínico randomizado, cego, para os avaliadores. Para avaliar a qualidade de vida, utilizou-se o questionário genérico SF-36 a fim de analisar os aspectos físicos e psicológicos em 24 pacientes do sexo feminino, portadoras de fibromialgia, com idade de 30 a 55 anos, alocadas aleatoriamente em dois grupos: hidrocinesioterapia e cinesioterapia. Durante um período de 23 semanas, as pacientes foram submetidas a alongamentos e exercícios aeróbios de baixa intensidade com duração de uma hora cada sessão (em ambos os grupos. RESULTADOS: Observou-se melhora estatisticamente significante (p < 0,05 na maior parte dos aspectos abordados pelo SF-36 em ambos os grupos. CONCLUSÃO: A hidrocinesioterapia promoveu um relaxamento muscular favorável para a melhora da qualidade de vida, porém, não foi o fator principal para amenizar os efeitos da patologia, uma vez que a cinesioterapia também proporcionou efeitos benéficos para a promoção do bem-estar dessas pacientes. Portanto, os alongamentos e os exercícios aeróbios de baixa intensidade empregados em ambos os protocolos são os prováveis responsáveis pelos efeitos benéficos observados nas duas modalidades terapêuticas analisadas.

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

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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

Estimulação magnética transcraniana de repetição associada a antidepressivo: início e intensidade da resposta antidepressiva Repetitive transcranial magnetic stimulation associated with antidepressant: start and intensive of the antidrepressant answer

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Demetrio Ortega Rumi

2004-01-01

Full Text Available OBJETIVOS: Avaliar diferentes estudos que analisam o grau de eficácia da resposta antidepressiva entre a associação de estimulação magnética transcraniana de repetição (EMTr com antidepressivos em pacientes deprimidos graves. MÉTODOS: Os autores revisaram vários estudos em que a EMTr foi usada concomitantemente a antidepressivos em pacientes deprimidos graves. Adicionalmente, relatou-se um estudo feito no Instituto de Psiquiatria do Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo. Estudo duplo-cego, randomizado, unicêntrico, placebo-controlado com 46 pacientes atendendo aos critérios diagnósticos da DSM-IV para episódio depressivo severo. Os pacientes estavam em uso de amitriptilina. RESULTADOS: De forma geral, a maioria dos estudos mostra que a EMTr apresenta boa eficácia antidepressiva quando associada a antidepressivos. Há grande diversidade de parâmetros técnicos utilizados, tipos de bobina, diferentes técnicas de placebo e uso de diferentes antidepressivos. O estudo realizado no Instituto de Psiquiatria mostrou que o emprego da EMTr de alta freqüência aumentou a resposta antidepressiva à amitriptilina e diminuiu o tempo para o início da resposta antidepressiva em relação ao grupo placebo. CONCLUSÕES: EMTr é um método novo, promissor e com grande potencial para o tratamento da depressão. Apesar disso, observa-se que não há ainda uniformidade no emprego dos parâmetros técnicos, nem tampouco das técnicas de placebo. O estudo realizado no Instituto de Psiquiatria do HC- FMUSP mostrou grandes taxas de resposta e remissão em relação ao grupo com estimulação sham e amitriptilna.OBJECTIVE: Transcranial magnetic stimulation has been developed as a noninvasive method to stimulate the cortex, and the treatment of depression is one of its potential therapeutic applications. This report makes a review about add-on trials (hf-rTMS plus antidepressants discuss whether rTMS does

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.

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.

Science.gov (United States)

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.

Movimento do ombro após cirurgia por carcinoma invasor da mama: estudo randomizado prospectivo controlado de exercícios livres versus limitados a 90º no pós-operatório Shoulder movement after surgery for invasive breast carcinoma: randomized controlled study of postoperative exercises

Directory of Open Access Journals (Sweden)

Marcela Ponzio Pinto e Silva

2004-03-01

Full Text Available OBJETIVO: avaliar a eficácia de um protocolo de exercícios físicos na recuperação do movimento do ombro em mulheres submetidas a esvaziamento linfonodal axilar por câncer de mama, comparando exercícios com amplitude livre e restrita do movimento. MÉTODOS: 59 mulheres submetidas a linfadenectomia axilar associada a mastectomia modificada (46 ou quadrantectomia (13 foram incluídas neste estudo clínico, prospectivo e randomizado. No primeiro dia após a cirurgia, 30 mulheres foram randomizadas para realizar os exercícios do ombro com amplitude livre do movimento e 29 mulheres tiveram a amplitude restrita a 90º nos primeiros 15 dias de pós-operatório. Eram realizados 19 exercícios, com três sessões semanais, por seis semanas. Foram comparadas as médias com desvio-padrão (DP de déficit de flexão e abdução do ombro, assim como as taxas de incidência bruta e ajustadas de seroma e deiscência. RESULTADOS: após 42 dias as médias de flexão e abdução do ombro foram semelhantes nos dois grupos. Houve déficit de flexão de 17,2º e 21,6º, e de abdução de 19,7º e 26,6º, nos grupos com exercício livre e limitado a 90º, respectivamente. As incidência de seroma e deiscência não estiveram relacionadas com o exercício nem com o tipo de cirurgia, tempo de permanência do dreno, número de linfonodos dissecados ou comprometidos, idade ou obesidade. CONCLUSÃO: a fisioterapia precoce com movimentação livre do ombro da mulher não esteve associada com o aumento ou diminuição da capacidade funcional e nem com maiores complicações cirúrgicas.PURPOSE: to evaluate the efficacy of a physical exercise protocol in the recovery of shoulder movement in women who underwent complete axillary lymph node dissection due to breast carcinoma, comparing free and restricted amplitude movements. METHODS: 59 women who underwent complete axillary lymph node dissection associated with modified mastectomy (46 or quadrantectomy (13 were

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

NARCIS (Netherlands)

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

Science.gov (United States)

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

Directory of Open Access Journals (Sweden)

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.

Science.gov (United States)

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

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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

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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.

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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 ?

OpenAIRE

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

DEFF Research Database (Denmark)

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

OpenAIRE

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.

Terapéuticas intervencionistas para el accidente cerebrovascular isquémico Update on interventional treatment of acute ischemic stroke

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Alejandra T. Rabadán

2010-10-01

Full Text Available En los últimos 20 años se han desarrollado nuevas opciones para el tratamiento y para la prevención del accidente cerebrovascular (ACV isquémico, muchas de ellas de carácter intervencionista, tales como la endarterectomía carotídea y la trombolisis intravenosa con activador tisular del plasminógeno. La evidencia científica ha llevado a su difusión y utilización en países desarrollados mientras que en naciones emergentes se observa un retraso en su adopción. Otras modalidades terapéuticas que parecen ser muy promisorias, aunque sin tanta evidencia científica que las avale, requieren la realización y conclusión de estudios randomizados. Dentro de la evolución del ACV isquémico existe una situación particular como es el infarto cerebral "maligno". Constituye un evento devastador, que se presenta en aproximadamente el 10 al 15% de los ACV carotídeos o silvianos, y está asociado con elevada morbimortalidad. Con la información disponible actualmente, es posible recomendar la craniectomía descompresiva (CD como un método efectivo y seguro para disminuir rápidamente la presión intracraneal y lograr un pronóstico favorable sobre una base racional. Aunque no hay estudios randomizados y controlados en la literatura, existe suficiente evidencia para recomendar la CD en casos especiales.New options have been developed for the prevention and treatment of acute ischemic stroke in the last 20 years, such as carotid endarterectomy and intravenous thrombolysis with tissue plasminogen activator. Scientific evidence has supported their use in developed countries, while there is an evident delay in their use among emerging countries. Other promising modalities require the conclusion of ongoing randomized, controlled trials. Malignant middle or carotid cerebral artery infarction accounts for 10 to 15% ischemic strokes and constitutes a devastating event associated with high morbidity and mortality. Decompressive craniectomy seems to be an

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

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

DEFF Research Database (Denmark)

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.

Science.gov (United States)

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.

Science.gov (United States)

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

The power and value of placebo and nocebo in painful osteoarthritis.

Science.gov (United States)

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.

Antibioticoterapia oral versus endovenosa em crianças neutropênicas febris recebendo quimioterapia Oral vs. intravenous empirical antimicrobial therapy in febrile neutropenic patients receiving childhood cancer chemotherapy

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Ângela Rech Cagol

2009-12-01

Full Text Available OBJETIVO: Comparar o uso de antibioticoterapia endovenosa versus oral. MÉTODOS: Foram selecionadas todas as crianças e adolescentes neutropênicos com idade inferior a 18 anos classificados como baixo risco para complicações e recebendo quimioterapia. O estudo ocorreu entre 2002 e 2005 na Unidade de Oncologia Pediátrica, Hospital de Clínicas de Porto Alegre, Porto Alegre (RS. Os pacientes, divididos em grupo A e grupo B, eram randomizados para receber terapia oral ou endovenosa. O tratamento utilizado para o grupo A foi ciprofloxacina e amoxicilina/clavulanato via oral e placebo endovenoso e, para o grupo B, cefepime e placebo oral. RESULTADOS: Foram selecionados 91 episódios consecutivos de neutropenia febril em 58 crianças. Para os pacientes do grupo A, a taxa de falência foi de 51,2% e a média de tempo de hospitalização foi de 8 dias (variação de 2-10. Para os pacientes tratados com antibioticoterapia endovenosa, a taxa de falência foi de 45,8% e a média de tempo de hospitalização foi de 7 dias (variação de 3-10. CONCLUSÃO: Neste estudo não houve diferenças entre a antibioticoterapia oral versus a terapia endovenosa. Estudos randomizados com maior número de pacientes são necessários antes de padronizar a terapêutica oral como tratamento para esta população de pacientes.OBJECTIVE: To compare the use of intravenous vs. oral antibiotic therapy. METHODS: All febrile neutropenic patients younger than 18 years old with low risk of complications and receiving chemotherapy were selected. The study was conducted from 2002 to 2005 at the Pediatric Oncology Unit of Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil. Patients were divided into group A and group B and were randomly assigned to receive oral or intravenous therapy. The empirical antimicrobial treatment used for group A consisted in oral ciprofloxacin plus amoxicillin-clavulanate and intravenous placebo, and group B received cefepime and oral placebo

Disability and pain after cortisone versus placebo injection for trapeziometacarpal arthrosis and de Quervain syndrome

NARCIS (Netherlands)

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.

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.

A systematic review found no consistent difference in effect between more and less intensive placebo interventions

DEFF Research Database (Denmark)

Fässler, Margrit; Meissner, Karin; Kleijnen, Jos

2015-01-01

this hypothesis. STUDY DESIGN AND SETTING: Eligible trials were identified through electronic database searches and citation tracking up to February 2013. Placebo interventions in a trial were categorized into a more intense and a less intense intervention based on complexity, invasiveness, or route...... intense and the less intense placebo intervention, four studies found differences for single outcomes, and one study consistently reported significantly larger effects of the more intense placebo. An explorative meta-analysis yielded a standardized mean difference -0.22 (95% confidence interval: -0.46, 0...

Choto-san in the treatment of vascular dementia: a double-blind, placebo-controlled study.

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Terasawa, K; Shimada, Y; Kita, T; Yamamoto, T; Tosa, H; Tanaka, N; Saito, Y; Kanaki, E; Goto, S; Mizushima, N; Fujioka, M; Takase, S; Seki, H; Kimura, I; Ogawa, T; Nakamura, S; Araki, G; Maruyama, I; Maruyama, Y; Takaori, S

1997-03-01

In an earlier placebo-controlled study, we demonstrated that a kampo (Japanese herbal) medicine called Choto-san (Diao-Teng-San in Chinese) was effective in treating vascular dementia. To evaluate its efficacy using more objective criteria, we carried out a multi-center, double-blind study of Choto-san extract (7.5 g/day) and a placebo, each given three times a day for 12 weeks to patients suffering from this condition. The study enrolled and analyzed 139 patients, 50 males and 89 females, with a mean age of 76.6 years. Choto-san was statistically superior to the placebo in global improvement rating, utility rating, global improvement rating of subjective symptoms, global improvement rating of psychiatric symptoms and global improvement rating of disturbance in daily living activities. Such items as spontaneity of conversation, lack of facial expression, decline in simple mathematical ability, global intellectual ability, nocturnal delirium, sleep disturbance, hallucination or delusion, and putting on and taking off clothes were significantly improved at one or more evaluation points in those taking Choto-san compared to those taking the placebo. Furthermore, the change in revised version of Hasegawa's dementia scale from the beginning point in Choto-san group was tended to be higher than that in placebo group with no statistical significance. These results suggest that Choto-san is effective in the treatment of vascular dementia. Copyright © 1997 Gustav Fischer Verlag. Published by Elsevier GmbH.. All rights reserved.

Exploring the Effect of Lactium™ and Zizyphus Complex on Sleep Quality: A Double-Blind, Randomized Placebo-Controlled Trial

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Andrew Scholey

2017-02-01

Full Text Available Acute, non-clinical insomnia is not uncommon. Sufferers commonly turn to short-term use of herbal supplements to alleviate the symptoms. This placebo-controlled, double-blind study investigated the efficacy of LZComplex3 (lactium™, Zizyphus, Humulus lupulus, magnesium and vitamin B6, in otherwise healthy adults with mild insomnia. After a 7-day single-blind placebo run-in, eligible volunteers (n = 171 were randomized (1:1 to receive daily treatment for 2 weeks with LZComplex3 or placebo. Results revealed that sleep quality measured by change in Pittsburgh Sleep Quality Index (PSQI score improved in both the LZComplex3 and placebo groups. There were no significant between group differences between baseline and endpoint on the primary outcome. The majority of secondary outcomes, which included daytime functioning and physical fatigue, mood and anxiety, cognitive performance, and stress reactivity, showed similar improvements in the LZComplex3 and placebo groups. A similar proportion of participants reported adverse events (AEs in both groups, with two of four treatment-related AEs in the LZComplex3 group resulting in permanent discontinuation. It currently cannot be concluded that administration of LZComplex3 for 2 weeks improves sleep quality, however, a marked placebo response (despite placebo run-in and/or short duration of treatment may have masked a potential beneficial effect on sleep quality.

Treatment for premenstrual syndrome with Vitex agnus castus: A prospective, randomized, multi-center placebo controlled study in China.

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He, Zhong; Chen, Rong; Zhou, Yingfang; Geng, Li; Zhang, Zhenyu; Chen, Shuling; Yao, Yanjun; Lu, Junli; Lin, Shouqing

2009-05-20

To investigate the efficacy and safety of VAC BNO 1095 extract in Chinese women suffering from moderate to severe premenstrual syndrome (PMS). Prospective, double-blind, placebo controlled, parallel-group, multi-center clinical trial design was employed. After screening and preparation phase lasting three cycles, Eligible patients were randomly assigned into treatment or placebo groups and had treatment with VAC extract or placebo for up to three cycles. Efficacy was assessed using the Chinese version PMS-diary (PMSD) and PMTS. Two hundred and seventeen women were eligible to enter the treatment phase (TP) and were randomly assigned into the treatment group (108) or the placebo group (109), 208 provided the efficacy data (treatment 104, placebo 104), and 202 completed the treatment phase (treatment 101, placebo 101). The mean total PMSD score decreased from 29.23 at baseline (0 cycle) to 6.41 at the termination (3rd cycle) for the treatment group and from 28.14 at baseline (0 cycle) to 12.64 at the termination (3rd cycle) for the placebo group. The total PMSD score of 3rd cycle was significantly lower than the baseline in both groups (pVitex agnus castus (VAC BNO 1095 corresponding to 40mg herbal drug) is a safe, well tolerated and effective drug of the treatment for Chinese women with the moderate to severe PMS.

Do placebo expectations influence perceived exertion during physical exercise?

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Hendrik Mothes

Full Text Available This study investigates the role of placebo expectations in individuals' perception of exertion during acute physical exercise. Building upon findings from placebo and marketing research, we examined how perceived exertion is affected by expectations regarding a the effects of exercise and b the effects of the exercise product worn during the exercise. We also investigated whether these effects are moderated by physical self-concept. Seventy-eight participants conducted a moderate 30 min cycling exercise on an ergometer, with perceived exertion (RPE measured every 5 minutes. Beforehand, each participant was randomly assigned to 1 of 4 conditions and watched a corresponding film clip presenting "scientific evidence" that the exercise would or would not result in health benefits and that the exercise product they were wearing (compression garment would additionally enhance exercise benefits or would only be worn for control purposes. Participants' physical self-concept was assessed via questionnaire. Results partially demonstrated that participants with more positive expectations experienced reduced perceived exertion during the exercise. Furthermore, our results indicate a moderator effect of physical self-concept: Individuals with a high physical self-concept benefited (in terms of reduced perceived exertion levels in particular from an induction of generally positive expectations. In contrast, individuals with a low physical self-concept benefited when positive expectations were related to the exercise product they were wearing. In sum, these results suggest that placebo expectations may be a further, previously neglected class of psychological factors that influence the perception of exertion.

Mindfulness Meditation-Based Pain Relief Employs Different Neural Mechanisms Than Placebo and Sham Mindfulness Meditation-Induced Analgesia

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Emerson, Nichole M.; Farris, Suzan R.; Ray, Jenna N.; Jung, Youngkyoo; McHaffie, John G.; Coghill, Robert C.

2015-01-01

Mindfulness meditation reduces pain in experimental and clinical settings. However, it remains unknown whether mindfulness meditation engages pain-relieving mechanisms other than those associated with the placebo effect (e.g., conditioning, psychosocial context, beliefs). To determine whether the analgesic mechanisms of mindfulness meditation are different from placebo, we randomly assigned 75 healthy, human volunteers to 4 d of the following: (1) mindfulness meditation, (2) placebo conditioning, (3) sham mindfulness meditation, or (4) book-listening control intervention. We assessed intervention efficacy using psychophysical evaluation of experimental pain and functional neuroimaging. Importantly, all cognitive manipulations (i.e., mindfulness meditation, placebo conditioning, sham mindfulness meditation) significantly attenuated pain intensity and unpleasantness ratings when compared to rest and the control condition (p Mindfulness meditation reduced pain intensity (p = 0.032) and pain unpleasantness (p Mindfulness meditation also reduced pain intensity (p = 0.030) and pain unpleasantness (p = 0.043) ratings more than sham mindfulness meditation. Mindfulness-meditation-related pain relief was associated with greater activation in brain regions associated with the cognitive modulation of pain, including the orbitofrontal, subgenual anterior cingulate, and anterior insular cortex. In contrast, placebo analgesia was associated with activation of the dorsolateral prefrontal cortex and deactivation of sensory processing regions (secondary somatosensory cortex). Sham mindfulness meditation-induced analgesia was not correlated with significant neural activity, but rather by greater reductions in respiration rate. This study is the first to demonstrate that mindfulness-related pain relief is mechanistically distinct from placebo analgesia. The elucidation of this distinction confirms the existence of multiple, cognitively driven, supraspinal mechanisms for pain

Mindfulness Meditation-Based Pain Relief Employs Different Neural Mechanisms Than Placebo and Sham Mindfulness Meditation-Induced Analgesia.

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Zeidan, Fadel; Emerson, Nichole M; Farris, Suzan R; Ray, Jenna N; Jung, Youngkyoo; McHaffie, John G; Coghill, Robert C

2015-11-18

Mindfulness meditation reduces pain in experimental and clinical settings. However, it remains unknown whether mindfulness meditation engages pain-relieving mechanisms other than those associated with the placebo effect (e.g., conditioning, psychosocial context, beliefs). To determine whether the analgesic mechanisms of mindfulness meditation are different from placebo, we randomly assigned 75 healthy, human volunteers to 4 d of the following: (1) mindfulness meditation, (2) placebo conditioning, (3) sham mindfulness meditation, or (4) book-listening control intervention. We assessed intervention efficacy using psychophysical evaluation of experimental pain and functional neuroimaging. Importantly, all cognitive manipulations (i.e., mindfulness meditation, placebo conditioning, sham mindfulness meditation) significantly attenuated pain intensity and unpleasantness ratings when compared to rest and the control condition (p pain intensity (p = 0.032) and pain unpleasantness (p pain intensity (p = 0.030) and pain unpleasantness (p = 0.043) ratings more than sham mindfulness meditation. Mindfulness-meditation-related pain relief was associated with greater activation in brain regions associated with the cognitive modulation of pain, including the orbitofrontal, subgenual anterior cingulate, and anterior insular cortex. In contrast, placebo analgesia was associated with activation of the dorsolateral prefrontal cortex and deactivation of sensory processing regions (secondary somatosensory cortex). Sham mindfulness meditation-induced analgesia was not correlated with significant neural activity, but rather by greater reductions in respiration rate. This study is the first to demonstrate that mindfulness-related pain relief is mechanistically distinct from placebo analgesia. The elucidation of this distinction confirms the existence of multiple, cognitively driven, supraspinal mechanisms for pain modulation. Recent findings have demonstrated that mindfulness meditation

Erythropoietin in amyotrophic lateral sclerosis: a multicentre, randomised, double blind, placebo controlled, phase III study.

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Lauria, Giuseppe; Dalla Bella, Eleonora; Antonini, Giovanni; Borghero, Giuseppe; Capasso, Margherita; Caponnetto, Claudia; Chiò, Adriano; Corbo, Massimo; Eleopra, Roberto; Fazio, Raffaella; Filosto, Massimiliano; Giannini, Fabio; Granieri, Enrico; La Bella, Vincenzo; Logroscino, Giancarlo; Mandrioli, Jessica; Mazzini, Letizia; Monsurrò, Maria Rosaria; Mora, Gabriele; Pietrini, Vladimiro; Quatrale, Rocco; Rizzi, Romana; Salvi, Fabrizio; Siciliano, Gabriele; Sorarù, Gianni; Volanti, Paolo; Tramacere, Irene; Filippini, Graziella

2015-08-01

To assess the efficacy of recombinant human erythropoietin (rhEPO) in amyotrophic lateral sclerosis (ALS). Patients with probable laboratory-supported, probable or definite ALS were enrolled by 25 Italian centres and randomly assigned (1:1) to receive intravenous rhEPO 40,000 IU or placebo fortnightly as add-on treatment to riluzole 100 mg daily for 12 months. The primary composite outcome was survival, tracheotomy or >23 h non-invasive ventilation (NIV). Secondary outcomes were ALSFRS-R, slow vital capacity (sVC) and quality of life (ALSAQ-40) decline. Tolerability was evaluated analysing adverse events (AEs) causing withdrawal. The randomisation sequence was computer-generated by blocks, stratified by centre, disease severity (ALSFRS-R cut-off score of 33) and onset (spinal or bulbar). The main outcome analysis was performed in all randomised patients and by intention-to-treat for the entire population and patients stratified by severity and onset. The study is registered, EudraCT 2009-016066-91. We randomly assigned 208 patients, of whom 5 (1 rhEPO and 4 placebo) withdrew consent and 3 (placebo) became ineligible (retinal thrombosis, respiratory insufficiency, SOD1 mutation) before receiving treatment; 103 receiving rhEPO and 97 placebo were eligible for analysis. At 12 months, the annualised rate of death (rhEPO 0.11, 95% CI 0.06 to 0.20; placebo: 0.08, CI 0.04 to 0.17), tracheotomy or >23 h NIV (rhEPO 0.16, CI 0.10 to 0.27; placebo 0.18, CI 0.11 to 0.30) did not differ between groups, also after stratification by onset and ALSFRS-R at baseline. Withdrawal due to AE was 16.5% in rhEPO and 8.3% in placebo. No differences were found for secondary outcomes. RhEPO 40,000 IU fortnightly did not change the course of ALS. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

A double-blind randomized placebo-controlled pilot study of neuropsychiatric adverse events in abstinent smokers treated with varenicline or placebo.

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Garza, Dahlia; Murphy, Michael; Tseng, Li-Jung; Riordan, Henry J; Chatterjee, Anjan

2011-06-01

Varenicline is an α4β2 partial nicotinic agonist approved for smoking cessation. There have been spontaneous postmarketing reports of neuropsychiatric adverse events (NPAEs) in smokers without a history of psychiatric illness quitting with varenicline. One hundred ten smokers without history of psychiatric illness (screened by Structured Clinical Interview for DSM-IV) were randomized to 12 weeks of varenicline 1 mg twice daily (n = 55) or placebo. Adverse events were solicited systematically. Depressive symptoms, anxiety, aggression, and irritability were measured at baseline and weekly using the Montgomery-Åsberg Depression Rating Scale (MADRS), the Hamilton Anxiety Scale (HAM-A), and the Overt Aggression Scale-Modified (OAS-M). The Profile of Mood States (POMS) was administered daily. Mixed-model analysis of repeated measures was conducted to compare mean changes in scores between groups across study periods. Participants' mean baseline characteristics were 33 years of age, 22 cigarettes/day and Fagerström Test for Nicotine Dependence score > 7. Reported NPAEs were similar between groups. No suicidal events were reported. There were no significant differences between groups for the MADRS (treatment difference vs. placebo = .03, 95% confidence interval [CI] -.68-.73; NS), HAM-A (treatment difference [TD] = .14, 95% CI -.62-.90; NS), OAS-M Aggression subscale (TD = .5, 95% CI -1.18-2.18; NS), OAS-M Irritability subscale (TD = .08, 95% CI -.17-.34; NS), and the POMS total scores (TD = .5, 95% CI -.52-1.53; NS). There were no significant differences between groups on measures of depressive symptoms, anxiety, or aggression/hostility. Systematically solicited NPAEs were similar between the varenicline and placebo groups. Copyright © 2011 Society of Biological Psychiatry. Published by Elsevier Inc. All rights reserved.

A randomized, double-blind, placebo-controlled study of escitalopram in patients with social anxiety disorder in Japan.

Science.gov (United States)

Asakura, Satoshi; Hayano, Taiji; Hagino, Atsushi; Koyama, Tsukasa

2016-01-01

This randomized, double-blind placebo-controlled study compared the efficacy and tolerability of escitalopram (10 and 20 mg/day) in Japanese patients with social anxiety disorder (SAD). Patients aged 18-64 years with a primary diagnosis of DSM-IV-TR defined SAD, a Liebowitz Social Anxiety Scale Japanese version (LSAS-J) total score ≥60 and a Clinical Global Impression-Severity (CGI-S) score ≥4 at baseline were randomly assigned (1:1:1) to placebo, escitalopram 10 mg or escitalopram 20 mg. The primary endpoint was change from baseline to Week 12 in the LSAS-J total score for both escitalopram 10 mg and 20 mg versus placebo (ANCOVA, FAS, LOCF), using a hierarchical testing procedure. Pre-specified secondary endpoints included LSAS-J sensitivity analyses. This study has the www.japic.or.jp identifier: JapicCTI-121842. For the primary efficacy endpoint, the difference from placebo in the LSAS-J was -3.9 (p = 0.089) for escitalopram 10 mg. Since the superiority of escitalopram 10 mg over placebo was not confirmed, an analysis without multiplicity adjustment was made, which showed a difference for escitalopram 20 mg versus placebo of -9.8 (p escitalopram 10 mg) and -10.1 (p escitalopram 20 mg). Common adverse events (incidence ≥5% and significantly different from placebo) were somnolence, nausea and ejaculation disorder. Escitalopram was efficacious, safe and well tolerated by patients with SAD in Japan. Study limitations are discussed including patient characteristics.

Urtica dioica for treatment of benign prostatic hyperplasia: a prospective, randomized, double-blind, placebo-controlled, crossover study.

Science.gov (United States)

Safarinejad, Mohammad Reza

2005-01-01

To determine the effects of therapy with Urtica dioica for symptomatic relief of lower urinary tract symptoms (LUTS) secondary to benign prostatic hyperplasia (BPH). A 6-month, double-blind, placebo-controlled, randomized, partial crossover, comparative trial of Urtica dioica with placebo in 620 patients was conducted. Patients were evaluated using the International Prostate Symptom Score (IPSS), the maximum urinary flow rate (Qmax), postvoid residual urine volume (PVR), Serum Prostatic- Specific Antigen (PSA), testosterone levels, and prostate size. At the end of 6-month trial, unblinding revealed that patients who initially received the placebo were switched to Urtica dioica. Both groups continued the medication up to 18 months. 558 patients (90%) completed the study (287/305, 91% in the Urtica dioica group, and 271/315, 86% in the placebo group). By intention- to-treat analysis, at the end of 6-month trial, 232 (81%) of 287 patients in the Urtica dioica group reported improved LUTS compared with 43 (16%) of 271 patients in the placebo group (P Urtica dioica and from 19.2 to 17.7 with placebo (P = 0.002). Peak flow rates improved by 3.4 mL/s for placebo recipients and by 8.2 mL/s for treated patients (P Urtica dioica group, PVR decreased from an initial value of 73 to 36 mL (P Urtica dioica group (from 40.1 cc initially to 36.3 cc; P Urtica dioica have beneficial effects in the treatment of symptomatic BPH. Further clinical trials should be conducted to confirm these results before concluding that Urtica dioica is effective.

Randomised controlled trial of homoeopathy versus placebo in perennial allergic rhinitis with overview of four trial series.

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Taylor, M A; Reilly, D; Llewellyn-Jones, R H; McSharry, C; Aitchison, T C

To test the hypothesis that homoeopathy is a placebo by examining its effect in patients with allergic rhinitis and so contest the evidence from three previous trials in this series. Randomised, double blind, placebo controlled, parallel group, multicentre study. Four general practices and a hospital ear, nose, and throat outpatient department. 51 patients with perennial allergic rhinitis. Random assignment to an oral 30c homoeopathic preparation of principal inhalant allergen or to placebo. Changes from baseline in nasal inspiratory peak flow and symptom visual analogue scale score over third and fourth weeks after randomisation. Fifty patients completed the study. The homoeopathy group had a significant objective improvement in nasal airflow compared with the placebo group (mean difference 19.8 l/min, 95% confidence interval 10.4 to 29.1, P=0.0001). Both groups reported improvement in symptoms, with patients taking homoeopathy reporting more improvement in all but one of the centres, which had more patients with aggravations. On average no significant difference between the groups was seen on visual analogue scale scores. Initial aggravations of rhinitis symptoms were more common with homoeopathy than placebo (7 (30%) v 2 (7%), P=0.04). Addition of these results to those of three previous trials (n=253) showed a mean symptom reduction on visual analogue scores of 28% (10.9 mm) for homoeopathy compared with 3% (1.1 mm) for placebo (95% confidence interval 4.2 to 15.4, P=0.0007). The objective results reinforce earlier evidence that homoeopathic dilutions differ from placebo.

Massage and Reiki used to reduce stress and anxiety: Randomized Clinical Trial.

Science.gov (United States)

Kurebayashi, Leonice Fumiko Sato; Turrini, Ruth Natalia Teresa; Souza, Talita Pavarini Borges de; Takiguchi, Raymond Sehiji; Kuba, Gisele; Nagumo, Marisa Toshi

2016-11-28

to evaluate the effectiveness of massage and reiki in the reduction of stress and anxiety in clients at the Institute for Integrated and Oriental Therapy in Sao Paulo (Brazil). clinical tests randomly done in parallel with an initial sample of 122 people divided into three groups: Massage + Rest (G1), Massage + Reiki (G2) and a Control group without intervention (G3). The Stress Systems list and the Trace State Anxiety Inventory were used to evaluate the groups at the start and after 8 sessions (1 month), during 2015. there were statistical differences (p = 0.000) according to the ANOVA (Analysis of Variance) for the stress amongst the groups 2 and 3 (p = 0.014) with a 33% reductions and a Cohen of 0.78. In relation to anxiety-state, there was a reduction in the intervention groups compared with the control group (p de estresse e ansiedade em clientes do Instituto de Terapia Integrada e Oriental, em São Paulo (Brasil). ensaio clínico controlado randomizado paralelo com amostra inicial de 122 pessoas divididas em 3 grupos Massagem+Repouso (G1), Massagem+Reiki (G2) e Controle sem intervenção (G3). Foram avaliados pela Lista de Sintomas de Stress e pelo Inventário de Ansiedade Traço-Estado, no início e após 8 sessões (1 mês), durante o ano de 2015. houve diferença estatística (p = 0,000) segundo ANOVA para o estresse entre os grupos 2 e 3 (33% de redução e Cohen de 0,98) e entre os grupos 1 e 3 (p = 0,014), 24% de redução e Cohen de 0,78. Para a ansiedade-estado, houve redução nos grupos de intervenção comparados ao grupo Controle (p de redução para o Grupo 2 (Cohen de 1,18) e 16% de redução para o grupo 1 (Cohen de 1,14). a Massagem+Reiki conseguiu melhores resultados entre os grupos e se sugere outro estudo com uso de placebo para o Reiki, para avaliar o alcance da técnica em separado. RBR-42c8wp. evaluar la efectividad de Masaje y Reiki para reducción del estrés y ansiedad en clientes del Instituto de Terapia Integrada y Oriental, en Sao

The efficacy of agomelatine in elderly patients with recurrent major depressive disorder: a placebo-controlled study.

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Heun, Reinhard; Ahokas, Antti; Boyer, Patrice; Giménez-Montesinos, Natalia; Pontes-Soares, Fernando; Olivier, Valérie

2013-06-01

The present placebo-controlled study evaluated the efficacy, tolerability, and safety of 8-week treatment with agomelatine (25-50 mg/d by mouth) in elderly patients with major depressive disorder (MDD). Elderly outpatients aged ≥ 65 years with a primary diagnosis of moderate to severe episode of recurrent MDD (DSM-IV-TR) were recruited in 27 clinical centers in Argentina, Finland, Mexico, Portugal, and Romania from November 2009 to October 2011. The primary outcome measure was the 17-item Hamilton Depression Rating Scale (HDRS17) total score. A total of 222 elderly patients entered the study (151 in the agomelatine group, 71 in the placebo group), including 69 patients aged 75 years and older. Agomelatine improved depressive symptoms in the elderly population, as evaluated by the HDRS17 total score, in terms of last postbaseline value (agomelatine-placebo difference: mean estimate [standard error] = 2.67 [1.06] points; P = .013) and response to treatment (agomelatine, 59.5%; placebo, 38.6%; P = .004). The agomelatine-placebo difference according to the Clinical Global Impressions-Severity of Illness scale (CGI-S) score was 0.48 (0.19). The agomelatine-placebo difference (estimate [standard error]) for remission on the HDRS17 was 6.9% (4.7%) and did not achieve statistical significance (P = .179, post hoc analysis). Clinically relevant effects of agomelatine were confirmed on all end points in the subset of severely depressed patients (HDRS17 total score ≥ 25 and CGI-S score ≥ 5 at baseline). Agomelatine was well tolerated by patients, with only minimal distinctions from placebo. The present study provides the first evidence that an 8-week treatment with agomelatine 25-50 mg/d efficiently relieves depressive symptoms and is well tolerated in elderly depressed patients older than 65 years. Controlled-Trials.com identifier: ISRCTN57507360. © Copyright 2011 Physicians Postgraduate Press, Inc.

Evaluation of a multi-herb supplement for erectile dysfunction: a randomized double-blind, placebo-controlled study.

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Shah, Gaurang R; Chaudhari, Manojkumar V; Patankar, Suresh B; Pensalwar, Shrikant V; Sabale, Vilas P; Sonawane, Navneet A

2012-09-15

Evidence is lacking for multi-ingredient herbal supplements claiming therapeutic effect in sexual dysfunction in men. We examined the safety and efficacy of VigRX Plus (VXP) - a proprietary polyherbal preparation for improving male sexual function, in a double blind, randomized placebo-controlled, parallel groups, multi-centre study. 78 men aged 25-50 years of age; suffering from mild to moderate erectile dysfunction (ED), participated in this study. Subjects were randomized to receive VXP or placebo at a dose of two capsules twice daily for 12 weeks. The international index of erectile function (IIEF) was the primary outcome measure of efficacy. Other efficacy measures were: Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS), Serum testosterone, Semen analysis, Investigator's Global assessment and Subjects' opinion. In subjects receiving VXP, the IIEF-Erectile Function (EF) scores improved significantly as compared to placebo. After 12 weeks of treatment, the mean (sd) IIEF-EF score at baseline increased from 16.08 (2.87) to 25.08 (4.56) in the VXP group versus 15.86 (3.24) to 16.47 (4.25) in the placebo group (P sexual desire, intercourse satisfaction, and overall satisfaction).There was a significant difference for VXP versus placebo comparison of mean (sd) EDITS scores of patients: 82.31(20.23) vs 36.78(22.53) and partners :(82.75(9.8) vs 18.50(9.44);P global assessment rated VXP therapy as very good to excellent in more than 50% patients and placebo therapy as fair to good in about 25% of patients. Incidence of side effects and subject's rating for tolerability of treatment was similar in both groups. VigRX Plus was well tolerated and more effective than placebo in improving sexual function in men. Clinical Trial Registry India, CTRI/2009/091/000099, 31-03-2009.

Theobromine for the treatment of persistent cough: a randomised, multicentre, double-blind, placebo-controlled clinical trial.

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Morice, Alyn H; McGarvey, Lorcan; Pavord, Ian D; Higgins, Bernard; Chung, Kian Fan; Birring, Surinder S

2017-07-01

To investigate the effect of BC1036 on health-related quality of life (QOL) in subjects with persistent cough. The secondary objective was to investigate the effect of BC1036 on subjective cough severity. This was a randomised, multicentre, double-blind, placebo-controlled, parallel-group study in 289 subjects with persistent cough. Subjects received BC1036 or placebo twice daily for 14 days. The primary endpoint comprised cough-related QOL assessed using the validated Leicester Cough Questionnaire (LCQ) at Day 14. Secondary endpoints comprised the LCQ scores at Day 7 and Day 28, cough severity VAS scores at each visit and pulmonary function tests. At baseline, mean total LCQ score in the BC1036 group was lower (i.e., worse QOL) than placebo (P<0.001), indicating significant between-group heterogeneity. Mean baseline-adjusted change in LCQ score at Day 14 was greater for BC1036 [mean (SD) 2.4±3.5] compared to placebo [mean (SD) score 2.2±3.0], but did not reach statistical significance (P=0.60). Mean cough severity VAS score decreased to a greater extent in the BC1036 group compared to placebo, but again the results were not statistically significant (-12.2±23.28 in BC1036 group and -11.0±21.34 in placebo group at Day 14, P=0.688). There was no significant change in pulmonary function measurements. The adverse event (AE) profile was similar in both groups. This study showed that BC1036 was well tolerated and, although the primary endpoint did not achieve statistical significance, the magnitude of improvement was greater with BC1036 compared to placebo with respect to improving QOL and reducing cough severity. ClinicalTrials.gov: NCT01656668.

A double-blind, placebo-controlled trial of sibutramine for clozapine-associated weight gain.

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Henderson, D C; Fan, X; Copeland, P M; Borba, C P; Daley, T B; Nguyen, D D; Zhang, H; Hayden, D; Freudenreich, O; Cather, C; Evins, A E; Goff, D C

2007-02-01

This study sought to examine the effectiveness of sibutramine, a weight loss agent, on clozapine-associated weight gain. This was a 12-week double-blind, placebo controlled, randomized trial of sibutramine for weight loss in obese clozapine-treated schizophrenia or schizoaffective disorder subjects. Ten patients were enrolled into the placebo group and 11 patients into the sibutramine group. There were no significant baseline differences between the two groups on age, gender, education, ethnicity, diagnosis, weight, body mass index (BMI), and blood pressure. At week 12, there were no significant differences in changes in weight, BMI, abdominal and waist circumferences, Hba1c, fasting glucose, or cholesterol levels. Sibutramine treatment did not show significant weight loss compared with placebo in clozapine-treated patients with schizophrenia or schizoaffective disorder. Further research with a larger sample size and longer follow-up duration is warranted.

EFFICACY OF CITALOPRAM IN TREATMENT OF PATHOLOGICAL SKIN PICKING, A RANDOMIZED DOUBLE BLIND PLACEBO CONTROLLED TRIAL

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M Arbabi

2008-11-01

Full Text Available "nVarious studies suggest that selective serotonin reuptake inhibitors (SSRIs may be useful in treating pathological skin picking (PSP. This study sought to assess effectiveness of citalopram in comparison with placebo in treating PSP. Forty five individuals with PSP were recruited in a four-week, randomized clinical trial of citalopram (20 mg/day in comparison with placebo. Study measures assessing skin picking severity, mental health status, obsessive compulsive disorder and quality of life were given at baseline, weeks 2 and 4. PSP severity, general health status, obsession-compulsion severity and quality of life level were similar between two groups at baseline (P > 0.05. Treatment analyses revealed significant improvements in quality of life, general health status and obsession-compulsion severity in citalopram group compared to placebo group (P < 0.05. Mean PSP severity reduction in citalopram group was more than placebo group but this difference was not significant. Citalopram can improve general health status and quality of life in individuals with PSP but its effect on skin picking behavior doesn't differ significantly with placebo. Other trials with longer time are needed to determine the exact efficacy of citalopram on PSP

Uso de morfina intratecal en artrodesis lumbar Uso da morfina intratecal na artrodese lombar Intrathecal morphine in lumbar spine fusion

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Ronald Schulz Ibaceta

2009-12-01

Full Text Available OBJETIVO: determinar la eficacia y la seguridad del uso de morfina intratecal, en bajas dosis, en pacientes sometidos a cirugía de instrumentación y artrodesis lumbar. MÉTODOS: estudio prospectivo, randomizado, ciego y controlado. Fueron utilizados dos grupos de pacientes: Grupo Estudio, que recibió morfina intratecal al final de su cirugía, y Grupo Control que sólo recibió el protocolo de analgesia estándar. RESULTADOS: se encontraron diferencias significativas en la escala visual análoga (EVA entre los dos grupos a las 12 horas postoperatorias. La EVA en reposo promedio del Grupo Estudio fue de 2,15 cm y el del Grupo Control, 5 cm (p=0,013. En actividad, el Grupo Estudio presentó una EVA promedio de 4,36 cm, y el Grupo Control 6,9 cm (p=0,029. No se encontraron diferencias en relación a las complicaciones entre los dos grupos. CONCLUSIÓN: el uso de morfina intratecal, en bajas dosis, es seguro y efectivo en el control del dolor en las primeras 12 horas postoperatorias en cirugía de artrodesis lumbar.OBJETIVO: determinar a eficácia e a seguridade do uso da morfina intratecal, em baixas doses, em pacientes submetidos à cirurgia de instrumentação e artrodese lombar. MÉTODOS: estudo prospectivo, randomizado, cego e controlado. Foram utilizados dois grupos de pacientes: Grupo Estudo, que recebeu morfina intratecal no final da cirurgia e o Grupo Controle, que recebeu somente o protocolo de analgesia padrão. RESULTADOS: foram encontradas diferenças significativas na escala visual analógica (EVA entre os dois grupos às 12 horas pós-operatórias. A EVA em repouso, em média, do Grupo Estudo foi de 2,15 cm e do Grupo Controle, 5 cm (p=0,013. Durante atividade, o Grupo Estudo apresentou uma EVA de aproximadamente 4,36 cm e no Grupo Controle, 6,9 cm (p=0,029. Não foram encontradas diferenças com relação às complicações entre os dois grupos. CONCLUSÃO: o uso de morfina intratecal, em baixas doses, foi seguro e efetivo no

Are we drawing the right conclusions from randomised placebo-controlled trials? A post-hoc analysis of data from a randomised controlled trial

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Bone Kerry M

2009-06-01

Full Text Available Abstract Background Assumptions underlying placebo controlled trials include that the placebo effect impacts on all study arms equally, and that treatment effects are additional to the placebo effect. However, these assumptions have recently been challenged, and different mechanisms may potentially be operating in the placebo and treatment arms. The objective of the current study was to explore the nature of placebo versus pharmacological effects by comparing predictors of the placebo response with predictors of the treatment response in a randomised, placebo-controlled trial of a phytotherapeutic combination for the treatment of menopausal symptoms. A substantial placebo response was observed but no significant difference in efficacy between the two arms. Methods A post hoc analysis was conducted on data from 93 participants who completed this previously published study. Variables at baseline were investigated as potential predictors of the response on any of the endpoints of flushing, overall menopausal symptoms and depression. Focused tests were conducted using hierarchical linear regression analyses. Based on these findings, analyses were conducted for both groups separately. These findings are discussed in relation to existing literature on placebo effects. Results Distinct differences in predictors were observed between the placebo and active groups. A significant difference was found for study entry anxiety, and Greene Climacteric Scale (GCS scores, on all three endpoints. Attitude to menopause was found to differ significantly between the two groups for GCS scores. Examination of the individual arms found anxiety at study entry to predict placebo response on all three outcome measures individually. In contrast, low anxiety was significantly associated with improvement in the active treatment group. None of the variables found to predict the placebo response was relevant to the treatment arm. Conclusion This study was a post hoc analysis

Placebo analgesia and reward processing: integrating genetics, personality, and intrinsic brain activity.

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Yu, Rongjun; Gollub, Randy L; Vangel, Mark; Kaptchuk, Ted; Smoller, Jordan W; Kong, Jian

2014-09-01

Our expectations about an event can strongly shape our subjective evaluation and actual experience of events. This ability, applied to the modulation of pain, has the potential to affect therapeutic analgesia substantially and constitutes a foundation for non-pharmacological pain relief. A typical example of such modulation is the placebo effect. Studies indicate that placebo may be regarded as a reward, and brain activity in the reward system is involved in this modulation process. In the present study, we combined resting-state functional magnetic resonance imaging (rs-fMRI) measures, genotype at a functional COMT polymorphism (Val158Met), and personality measures in a model to predict the magnitude of placebo conditioning effect indicated by subjective pain rating reduction to calibrated noxious stimuli. We found that the regional homogeneity (ReHo), an index of local neural coherence, in the ventral striatum, was significantly associated with conditioning effects on pain rating changes. We also found that the number of Met alleles at the COMT polymorphism was linearly correlated to the suppression of pain. In a fitted regression model, we found the ReHo in the ventral striatum, COMT genotype, and Openness scores accounted for 59% of the variance in the change in pain ratings. The model was further tested using a separate data set from the same study. Our findings demonstrate the potential of combining resting-state connectivity, genetic information, and personality to predict placebo effect. Copyright © 2014 Wiley Periodicals, Inc.

Male hormonal contraception: a double-blind, placebo-controlled study.

NARCIS (Netherlands)

Mommers, E.; Kersemaekers, W.M.; Elliesen, J.; Kepers, M.; Apter, D.; Behre, H.M.; Beynon, J.; Bouloux, P.M.; Costantino, A.; Gerbershagen, H.P.; Gronlund, L.; Heger-Mahn, D.; Huhtaniemi, I.; Koldewijn, E.L.; Lange, C.; Lindenberg, S.; Meriggiola, M.C.; Meuleman, E.J.H.; Mulders, P.F.A.; Nieschlag, E.; Perheentupa, A.; Solomon, A.; Vaisala, L.; Wu, F.C.; Zitzmann, M.

2008-01-01

BACKGROUND: This study was performed to assess spermatogenesis suppression and safety of a new combination of an etonogestrel (ENG) implant combined with testosterone undecanoate (TU) injections for male contraception. This is the first large placebo-controlled study for male hormonal contraception.

Effect of Low Concentrations of Apomorphine on Parkinsonism in a Randomized, Placebo-Controlled, Crossover Study

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Gunzler, Steven A.; Koudelka, Caroline; Carlson, Nichole E.; Pavel, Misha; Nutt, John G.

2011-01-01

Objective To determine whether low concentrations of a dopamine agonist worsen parkinsonism, which would suggest that activation of presynaptic dopamine autoreceptors causes a super-off state. Design Randomized, double-blind, placebo-controlled, crossover clinical trial. Setting Academic movement disorders center. Patients Patients with Parkinson disease and motor fluctuations. Intervention Fourteen patients with Parkinson disease and motor fluctuations were randomized to receive 1 of 6 possible sequences of placebo, low-dose (sub-threshold) apomorphine hydrochloride, and high-dose (threshold to suprathreshold) apomorphine hydrochloride infusions. Subthreshold doses of apomorphine hydrochloride (12.5 μg/kg/h every 2 hours and 25 μg/kg/h every 2 hours), threshold to suprathreshold doses of apomorphine hydrochloride (50 μg/kg/h every 2 hours and 100 μg/kg/h every 2 hours), and placebo were infused for 4 hours daily for 3 consecutive days. Main Outcome Measures Finger and foot tapping rates. Results There was no decline in finger or foot tapping rates during the low-dose apomorphine hydrochloride infusions relative to placebo. The high-dose infusions increased foot tapping (P<.001) and trended toward increasing finger tapping compared with placebo infusions. Conclusions Subthreshold concentrations of apomorphine did not worsen parkinsonism, suggesting that pre-synaptic dopamine autoreceptors are not important to the motor response in moderate to advanced Parkinson disease. PMID:18268187

Assessment of proprioceptive exercises in the treatment of rotator cuff disorders in nursing professionals: a randomized controlled clinical trial Avaliação dos exercícios proprioceptivos no tratamento dos distúrbios do manguito rotador em profissionais de enfermagem: um estudo clínico controlado e randomizado

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Lisandra V Martins

2012-01-01

efeito da aplicação de dois programas fisioterapêuticos diferenciados pelos exercícios de propriocepção em trabalhadores de enfermagem com desordem do manguito rotador, segundo indicadores de qualidade de vida, satisfação no trabalho e intensidade da dor. MÉTODO: Trata-se de um estudo experimental, randomizado, prospectivo, comparativo, com análise quantitativa dos dados. A coleta de dados foi realizada no período de junho de 2010 a julho de 2011, por meio de um questionário sociodemográfico e profissional, questionário Western Ontario Rotador Cuff Index (WORC, Escala de Satisfação no Trabalho (Occupational Stress Indicator e Escala Visual Numérica (EVN para intensidade da dor. Após randomização, os sujeitos foram alocados em dois grupos. No Grupo 1 (controle, foram aplicados exercícios de alongamento, fortalecimento e crioterapia. No Grupo 2 (experimental, foram realizados os mesmos exercícios que no Grupo 1 acrescidos de exercícios proprioceptivos. Os dados foram analisados por meio do Statistical Package for the Social Science, versão 16.0 para Windows. RESULTADOS: Após os tratamentos fisioterapêuticos, houve melhora significativa da dor nos sujeitos dos dois grupos e da qualidade de vida nos trabalhadores do Grupo 2. Não houve alteração dos indicadores de satisfação no trabalho nos dois grupos. CONCLUSÕES: Os exercícios proprioceptivos foram importantes no tratamento dos distúrbios osteomusculares. No entanto, os resultados não permitiram inferir a melhor efetividade deles em relação ao outro tratamento, pois não houve diferença significativa entre os grupos. Ensaio clínico registrado no ClinicalTrials.gov NCT01465932.

Assessment of proprioceptive exercises in the treatment of rotator cuff disorders in nursing professionals: a randomized controlled clinical trial Avaliação dos exercícios proprioceptivos no tratamento dos distúrbios do manguito rotador em profissionais de enfermagem: um estudo clínico controlado e randomizado

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Lisandra V Martins

2012-12-01

êuticos diferenciados pelos exercícios de propriocepção em trabalhadores de enfermagem com desordem do manguito rotador, segundo indicadores de qualidade de vida, satisfação no trabalho e intensidade da dor. MÉTODO: Trata-se de um estudo experimental, randomizado, prospectivo, comparativo, com análise quantitativa dos dados. A coleta de dados foi realizada no período de junho de 2010 a julho de 2011, por meio de um questionário sociodemográfico e profissional, questionário Western Ontario Rotador Cuff Index (WORC, Escala de Satisfação no Trabalho (Occupational Stress Indicator e Escala Visual Numérica (EVN para intensidade da dor. Após randomização, os sujeitos foram alocados em dois grupos. No Grupo 1 (controle, foram aplicados exercícios de alongamento, fortalecimento e crioterapia. No Grupo 2 (experimental, foram realizados os mesmos exercícios que no Grupo 1 acrescidos de exercícios proprioceptivos. Os dados foram analisados por meio do Statistical Package for the Social Science, versão 16.0 para Windows. RESULTADOS: Após os tratamentos fisioterapêuticos, houve melhora significativa da dor nos sujeitos dos dois grupos e da qualidade de vida nos trabalhadores do Grupo 2. Não houve alteração dos indicadores de satisfação no trabalho nos dois grupos. CONCLUSÕES: Os exercícios proprioceptivos foram importantes no tratamento dos distúrbios osteomusculares. No entanto, os resultados não permitiram inferir a melhor efetividade deles em relação ao outro tratamento, pois não houve diferença significativa entre os grupos. Ensaio clínico registrado no ClinicalTrials.gov NCT01465932.

Influência da suplementação de creatina na capacidade funcional de pacientes com Insuficiência Cardíaca

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Ana Paula Perillo Ferreira Carvalho

2012-07-01

Full Text Available FUNDAMENTO: A Insuficiência Cardíaca (IC é uma síndrome complexa, marcada pela intolerância ao esforço e perda da capacidade funcional. OBJETIVO: Avaliar a capacidade funcional dos pacientes com IC suplementados com creatina. MÉTODOS: Estudo prospectivo, randomizado, duplo cego. Foram randomizados em dois grupos 33 pacientes com IC, com idade > 18 anos, sexo masculino, classes funcionais II a IV. O grupo experimental (G CRE, n = 17 foi suplementado com creatina com dose de 5 g por dia durante seis meses. E o grupo placebo (G PLA, n = 16 recebeu 5 g de maltodextrina por dia durante o mesmo período de tempo. Ambos os grupos foram submetidos a avaliação da capacidade funcional por meio da ergoespirometria e teste de caminhada de seis minutos (TC6 pré e pós-intervenção. O modelo estatístico Ancova e a correlação de Pearson foram utilizados na análise dos grupos e nas formas de tratamento. RESULTADOS: Das variáveis avaliadas na ergoespirometria, o volume de oxigênio pico (VO2 pico, limiar anaeróbio (LA e o pulso de oxigênio (pulso de O2 não apresentaram diferenças significativas entre os grupos (P>0,05. No TC6 não houve diferença significativa na distância percorrida. CONCLUSÃO: A suplementação de creatina em pacientes com IC não promoveu melhora significativa na capacidade funcional.

Efficient assessment of efficacy in post-traumatic peripheral neuropathic pain patients: pregabalin in a randomized, placebo-controlled, crossover study

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Jenkins TM

2012-07-01

Full Text Available Tim M Jenkins, Trevor S Smart, Frances Hackman, Carol Cooke, Keith KC TanClinical Research, Pfizer Worldwide Research and Development, Sandwich, Kent, UKBackground: Detecting the efficacy of novel analgesic agents in neuropathic pain is challenging. There is a critical need for study designs with the desirable characteristics of assay sensitivity, low placebo response, reliable pain recordings, low cost, short duration of exposure to test drug and placebo, and relevant and recruitable population.Methods: We designed a proof-of-concept, double-blind, randomized, placebo-controlled, crossover study in patients with post-traumatic peripheral neuropathic pain (PTNP to evaluate whether such a study design had the potential to detect efficacious agents. Pregabalin, known to be efficacious in neuropathic pain, was used as the active analgesic. We also assessed physical activity throughout the study.Results: Twenty-five adults (20–70 years of age with PTNP for ≥3 months entered a screening week and were then randomized to one of the two following treatment sequences: (1 pregabalin followed by placebo or (2 placebo followed by pregabalin. These 2-week treatment periods were separated by a 2-week washout period. Patients on pregabalin treatment received escalating doses to a final dosage of 300 mg/day (days 5–15. In an attempt to minimize placebo response, patients received placebo treatment during the screening week and the 2-week washout period. Average daily pain scores (primary endpoint were significantly reduced for pregabalin versus placebo, with a mean treatment difference of -0.81 (95% confidence interval: -1.45 to -0.17; P = 0.015.Conclusion: The efficacy of pregabalin was similar to that identified in a large, parallel group trial in PTNP. Therefore, this efficient crossover study design has potential utility for future proof-of-concept studies in neuropathic pain.Keywords: pregabalin, post-traumatic peripheral neuropathic pain, randomized

Safety of polyethylene glycol 3350 solution in chronic constipation: randomized, placebo-controlled trial

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McGraw T

2016-07-01

Full Text Available Thomas McGraw Global Medical Affairs, Merck & Co., Inc., Kenilworth, NJ, USA Purpose: To evaluate the safety and tolerability of aqueous solution concentrate (ASC of polyethylene glycol (PEG 3350 in patients with functional constipation.Patients and methods: 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 follow-up 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.Results: 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

Eplerenone for early cardiomyopathy in Duchenne muscular dystrophy: a randomised, double-blind, placebo-controlled trial.

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Raman, Subha V; Hor, Kan N; Mazur, Wojciech; Halnon, Nancy J; Kissel, John T; He, Xin; Tran, Tam; Smart, Suzanne; McCarthy, Beth; Taylor, Michael D; Jefferies, John L; Rafael-Fortney, Jill A; Lowe, Jeovanna; Roble, Sharon L; Cripe, Linda H

2015-02-01

Cardiomyopathy is a leading cause of death in patients with Duchenne muscular dystrophy and myocardial damage precedes decline in left ventricular systolic function. We tested the efficacy of eplerenone on top of background therapy in patients with Duchenne muscular dystrophy with early myocardial disease. In this randomised, double-blind, placebo-controlled trial, boys from three centres in the USA aged 7 years or older with Duchenne muscular dystrophy, myocardial damage by late gadolinium enhancement cardiac MRI and preserved ejection fraction received either eplerenone 25 mg or placebo orally, every other day for the first month and once daily thereafter, in addition to background clinician-directed therapy with either angiotensin-converting enzyme inhibitors (ACEI) or angiotensin receptor blockers (ARB). Computer-generated randomisation was done centrally using block sizes of four and six, and only the study statistician and the investigational pharmacy had the preset randomisation assignments. The primary outcome was change in left ventricular circumferential strain (Ecc) at 12 months, a measure of contractile dysfunction. Safety was established through serial serum potassium levels and measurement of cystatin C, a non-creatinine measure of kidney function. This trial is registered with ClinicalTrials.gov, number NCT01521546. Between Jan 26, 2012, and July 3, 2013, 188 boys were screened and 42 were enrolled. 20 were randomly assigned to receive eplerenone and 22 to receive placebo, of whom 20 in the eplerenone group and 20 in the placebo group completed baseline, 6-month, and 12-month visits. After 12 months, decline in left ventricular circumferential strain was less in those who received eplerenone than in those who received placebo (median ΔEcc 1·0 [IQR 0·3-2·2] vs 2·2 [1·3-3·1]; p=0·020). Cystatin C concentrations remained normal in both groups, and all non-haemolysed blood samples showed normal potassium concentrations. One 23-year-old patient in

Los efectos placebo de la relación médico-paciente The placebo effects of the physician-patient relationship

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Ricardo González Menéndez

2004-12-01

Full Text Available Luego de breves comentarios históricos que abordan la influencia del primer modelo psicoterapéutico en la ya superada tendencia a considerar la psicoterapia como fuera del alcance del médico generalista, se comentan los aportes de Carl Rogers al enfatizar la trascendencia de las actitudes del facultativo en la relación interpersonal y su mayor trascendencia sobre los métodos y recursos psicoterapéuticos elegidos. Se destaca igualmente los resultados similares obtenidos en estudios orientados a comparar diferentes modalidades psicoterapéuticas, hallazgos que ratifican la importancia de los vínculos afectivos establecidos entre el profesional de la salud y sus pacientes cuando la relación médico-paciente es exitosa. Se describen los 6 efectos placebo de esta relación descritos por Shapiro y Frank desde 1971 y se agregan otros 4 surgidos de las reflexiones del equipo de trabajo del autor. Se insiste en que las limitaciones iniciales establecidas al médico generalista sobre sus responsabilidades psicoterapéuticas, resultan actualmente insostenibles para los facultativos capaces de sensibilizarse ante el drama humano de un paciente. Se concluye que las pontecialidades terapéuticas implícitas en los efectos placebos descritos justifican cada vez más la incursión del médico generalista en la relación de ayuda psicológica.After some brief historical comments dealing with the influence of the first psychotherapeutic model on the already overcome trend to consider psychotherapy as out of the reach of the general physcian, the contributions of Carl Rogers are exposed on emphasizing the transcendency of the physcian's attitudes in the interpersonal relation and its greater transcendence in relation to the selected psychotherapeutic methods and resources. The similar results attained in the studies oriented to compare different psychotherapeutic modalities are also stressed. These findings ratify the importance of the affective links

A randomized, double-blind, placebo-controlled multicenter trial evaluating topical zinc oxide for acute open wounds following pilonidal disease excision

DEFF Research Database (Denmark)

Ågren, Magnus S.; Ostenfeld, Ulla; Kallehave, Finn Lasse

2006-01-01

The purpose of this randomized, double-blind, placebo-controlled multicenter trial was to compare topical zinc oxide with placebo mesh on secondary healing pilonidal wounds. Sixty-four (53 men) consecutive patients, aged 17-60 years, were centrally randomized to either treatment with 3% zinc oxide...... (n = 33) or placebo (n = 31) by concealed allocation. Patients were followed with strict recording of beneficial and harmful effects including masked assessment of time to complete wound closure. Analysis was carried out on an intention-to-treat basis. Median healing times were 54 days (interquartile...... range 42-71 days) for the zinc and 62 days (55-82 days) for the placebo group (p = 0.32). Topical zinc oxide increased (p placebo...

Minoxidil 2% lotion for eyebrow enhancement: a randomized, double-blind, placebo-controlled, spilt-face comparative study.

Science.gov (United States)

Lee, Saridpong; Tanglertsampan, Chuchai; Tanchotikul, Mingkwan; Worapunpong, Nigun

2014-02-01

Topical minoxidil has been successfully used to treat androgenetic alopecia. It can also be applied to enhance eyebrows. However, there is no study comparing minoxidil lotion with placebo for eyebrow enhancement. In this trial, we determined the efficacy and safety of minoxidil 2% lotion for eyebrow enhancement compared with placebo. Forty patients were randomized for minoxidil on the eyebrow on one side of the face and placebo on the other. Efficacy was evaluated by global photographic assessment, eyebrow diameter, eyebrow count and subject's satisfaction. Side-effects were also evaluated. Thirty-nine patients (97.5%) completed the study. After 16 weeks, the minoxidil group achieved significantly better results in all measured outcomes compared to the placebo group. Side-effects were minor and did not preclude patients from continuing the study. Our study suggests that minoxidil 2% lotion is a safe and effective treatment for eyebrow hypotrichosis. © 2014 Japanese Dermatological Association.

A phase 3 randomized placebo-controlled trial of tadalafil for Duchenne muscular dystrophy.

Science.gov (United States)

Victor, Ronald G; Sweeney, H Lee; Finkel, Richard; McDonald, Craig M; Byrne, Barry; Eagle, Michelle; Goemans, Nathalie; Vandenborne, Krista; Dubrovsky, Alberto L; Topaloglu, Haluk; Miceli, M Carrie; Furlong, Pat; Landry, John; Elashoff, Robert; Cox, David

2017-10-24

To conduct a randomized trial to test the primary hypothesis that once-daily tadalafil, administered orally for 48 weeks, lessens the decline in ambulatory ability in boys with Duchenne muscular dystrophy (DMD). Three hundred thirty-one participants with DMD 7 to 14 years of age taking glucocorticoids were randomized to tadalafil 0.3 mg·kg -1 ·d -1 , tadalafil 0.6 mg·kg -1 ·d -1 , or placebo. The primary efficacy measure was 6-minute walk distance (6MWD) after 48 weeks. Secondary efficacy measures included North Star Ambulatory Assessment and timed function tests. Performance of Upper Limb (PUL) was a prespecified exploratory outcome. Tadalafil had no effect on the primary outcome: 48-week declines in 6MWD were 51.0 ± 9.3 m with placebo, 64.7 ± 9.8 m with low-dose tadalafil ( p = 0.307 vs placebo), and 59.1 ± 9.4 m with high-dose tadalafil ( p = 0.538 vs placebo). Tadalafil also had no effect on secondary outcomes. In boys >10 years of age, total PUL score and shoulder subscore declined less with low-dose tadalafil than placebo. Adverse events were consistent with the known safety profile of tadalafil and the DMD disease state. Tadalafil did not lessen the decline in ambulatory ability in boys with DMD. Further studies should be considered to confirm the hypothesis-generating upper limb data and to determine whether ambulatory decline can be slowed by initiation of tadalafil before 7 years of age. NCT01865084. This study provides Class I evidence that tadalafil does not slow ambulatory decline in 7- to 14-year-old boys with Duchenne muscular dystrophy. Copyright © 2017 The Author(s). Published by Wolters Kluwer Health, Inc. on behalf of the American Academy of Neurology.

Dietary nitrate improves vascular function in patients with hypercholesterolemia: a randomized, double-blind, placebo-controlled study123

Science.gov (United States)

Velmurugan, Shanti; Gan, Jasmine Ming; Rathod, Krishnaraj S; Khambata, Rayomand S; Ghosh, Suborno M; Hartley, Amy; Van Eijl, Sven; Sagi-Kiss, Virag; Chowdhury, Tahseen A; Curtis, Mike; Kuhnle, Gunter GC; Wade, William G; Ahluwalia, Amrita

2016-01-01

Background: The beneficial cardiovascular effects of vegetables may be underpinned by their high inorganic nitrate content. Objective: We sought to examine the effects of a 6-wk once-daily intake of dietary nitrate (nitrate-rich beetroot juice) compared with placebo intake (nitrate-depleted beetroot juice) on vascular and platelet function in untreated hypercholesterolemics. Design: A total of 69 subjects were recruited in this randomized, double-blind, placebo-controlled parallel study. The primary endpoint was the change in vascular function determined with the use of ultrasound flow-mediated dilatation (FMD). Results: Baseline characteristics were similar between the groups, with primary outcome data available for 67 patients. Dietary nitrate resulted in an absolute increase in the FMD response of 1.1% (an ∼24% improvement from baseline) with a worsening of 0.3% in the placebo group (P nitrate group, showing a trend (P = 0.06) to improvement in comparison with the placebo group. Dietary nitrate also caused a small but significant reduction (7.6%) in platelet-monocyte aggregates compared with an increase of 10.1% in the placebo group (P = 0.004), with statistically significant reductions in stimulated (ex vivo) P-selectin expression compared with the placebo group (P nitrate were detected. The composition of the salivary microbiome was altered after the nitrate treatment but not after the placebo treatment (P nitrate treatment; of those taxa present, 2 taxa were responsible for >1% of this change, with the proportions of Rothia mucilaginosa trending to increase and Neisseria flavescens (P nitrate treatment relative to after placebo treatment. Conclusions: Sustained dietary nitrate ingestion improves vascular function in hypercholesterolemic patients. These changes are associated with alterations in the oral microbiome and, in particular, nitrate-reducing genera. Our findings provide additional support for the assessment of the potential of dietary nitrate as a

Dopaminergic tone does not influence pain levels during placebo interventions in patients with chronic neuropathic pain.

Science.gov (United States)

Skyt, Ina; Moslemi, Kurosh; Baastrup, Cathrine; Grosen, Kasper; Benedetti, Fabrizio; Petersen, Gitte L; Price, Donald D; Hall, Kathryn T; Kaptchuk, Ted J; Svensson, Peter; Jensen, Troels S; Vase, Lene

2017-10-23

Placebo effects have been reported in patients with chronic neuropathic pain. Expected pain levels and positive emotions are involved in the observed pain relief, but the underlying neurobiology is largely unknown. Patients with neuropathic pain are highly motivated for pain relief, and as motivational factors such as expectations of reward, as well as pain processing in itself, are related to the dopaminergic system, it can be speculated that dopamine release contributes to placebo effects in neuropathic pain. Nineteen patients with neuropathic pain after thoracic surgery were tested during a placebo intervention consisting of open and hidden applications of the pain-relieving agent lidocaine (2 mL) and no treatment. The dopamine antagonist haloperidol (2 mg) and the agonist levodopa/carbidopa (100/25 mg) were administered to test the involvement of dopamine. Expected pain levels, desire for pain relief, and ongoing and evoked pain were assessed on mechanical visual analog scales (0-10). Significant placebo effects on ongoing (P ≤ 0.003) and evoked (P ≤ 0.002) pain were observed. Expectancy and desire accounted for up to 41.2% and 71.5% of the variance in ongoing and evoked pain, respectively, after the open application of lidocaine. We found no evidence for an effect of haloperidol and levodopa/carbidopa on neuropathic pain levels (P = 0.071-0.963). Dopamine seemed to influence the levels of expectancy and desire, yet there was no evidence for indirect or interaction effects on the placebo effect. This is the first study to suggest that dopamine does not contribute to placebo effects in chronic neuropathic pain.

A placebo-controlled investigation of synaesthesia-like experiences under LSD.

Science.gov (United States)

Terhune, Devin B; Luke, David P; Kaelen, Mendel; Bolstridge, Mark; Feilding, Amanda; Nutt, David; Carhart-Harris, Robin; Ward, Jamie

2016-07-29

The induction of synaesthesia in non-synaesthetes has the potential to illuminate the mechanisms that contribute to the development of this condition and the shaping of its phenomenology. Previous research suggests that lysergic acid diethylamide (LSD) reliably induces synaesthesia-like experiences in non-synaesthetes. However, these studies suffer from a number of methodological limitations including lack of a placebo control and the absence of rigorous measures used to test established criteria for genuine synaesthesia. Here we report a pilot study that aimed to circumvent these limitations. We conducted a within-groups placebo-controlled investigation of the impact of LSD on colour experiences in response to standardized graphemes and sounds and the consistency and specificity of grapheme- and sound-colour associations. Participants reported more spontaneous synaesthesia-like experiences under LSD, relative to placebo, but did not differ across conditions in colour experiences in response to inducers, consistency of stimulus-colour associations, or in inducer specificity. Further analyses suggest that individual differences in a number of these effects were associated with the propensity to experience states of absorption in one's daily life. Although preliminary, the present study suggests that LSD-induced synaesthesia-like experiences do not exhibit consistency or inducer-specificity and thus do not meet two widely established criteria for genuine synaesthesia. Copyright © 2016 Elsevier Ltd. All rights reserved.

Tofacitinib for induction and maintenance therapy of Crohn's disease: results of two phase IIb randomised placebo-controlled trials.

Science.gov (United States)

Panés, Julian; Sandborn, William J; Schreiber, Stefan; Sands, Bruce E; Vermeire, Séverine; D'Haens, Geert; Panaccione, Remo; Higgins, Peter D R; Colombel, Jean-Frederic; Feagan, Brian G; Chan, Gary; Moscariello, Michele; Wang, Wenjin; Niezychowski, Wojciech; Marren, Amy; Healey, Paul; Maller, Eric

2017-06-01

Tofacitinib is an oral, small-molecule Janus kinase inhibitor that is being investigated for IBD. We evaluated the efficacy and safety of tofacitinib for induction and maintenance treatment in patients with moderate-to-severe Crohn's disease (CD). We conducted two randomised, double-blind, placebo-controlled, multicentre phase IIb studies. Adult patients with moderate-to-severe CD were randomised to receive induction treatment with placebo, tofacitinib 5 or 10 mg twice daily for 8 weeks. Those achieving clinical response-100 or remission were re-randomised to maintenance treatment with placebo, tofacitinib 5 or 10 mg twice daily for 26 weeks. Primary endpoints were clinical remission at the end of the induction study, and clinical response-100 or remission at the end of the maintenance study. 180/280 patients randomised in the induction study were enrolled in the maintenance study. At week 8 of induction, the proportion of patients with clinical remission was 43.5% and 43.0% with 5 and 10 mg twice daily, respectively, compared with 36.7% in the placebo group (p=0.325 and 0.392 for 5 and 10 mg twice daily vs placebo). At week 26 of maintenance, the proportion of patients with clinical response-100 or remission was 55.8% with tofacitinib 10 mg twice daily compared with 39.5% with tofacitinib 5 mg twice daily and 38.1% with placebo (p=0.130 for 10 mg twice daily vs placebo). Compared with placebo, the change in C-reactive protein from baseline was statistically significant (ptofacitinib. NCT01393626 and NCT01393899. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.

Effects of nicotine versus placebo e-cigarette use on symptom relief during initial tobacco abstinence.

Science.gov (United States)

Perkins, Kenneth A; Karelitz, Joshua L; Michael, Valerie C

2017-08-01

Because electronic cigarettes (e-cigs) containing nicotine may relieve smoking abstinence symptoms similar to nicotine replacement therapy medication, we used within-subjects designs to test these effects with a first-generation e-cig in nonquitting and quitting smokers. In Study 1, 28 nontreatment-seeking smokers abstained overnight prior to each of 3 sessions. Minnesota Nicotine Withdrawal Scale (MNWS) withdrawal (and craving item) relief was assessed following 4 exposures (each 10 puffs) over 2 hr to e-cigs that either did (36 mg/ml) or did not (i.e., placebo, 0 mg/ml) contain nicotine or after no e-cig. Relief was greater after nicotine versus placebo e-cig (p < .05) but not after placebo versus no e-cig, showing relief was due to nicotine per se and not simple e-cig use behavior. Using a crossover design in Study 2, smokers preparing to quit soon engaged in 2 experimental 4-day quit periods on separate weeks. In weeks 1 and 3, all received a nicotine or placebo e-cig on Monday to use ad libitum while trying to abstain from smoking on Tuesday through Friday. (Week 2 involved resumption of ad libitum smoking.) MNWS and Questionnaire of Smoking Urges (QSU) craving were assessed at daily visits following 24-hr abstinence. Of 17 enrolled, 12 quit for ≥24 hr at least once, allowing test of relief because of e-cig use on quit days. Withdrawal and craving were reduced because of nicotine versus placebo e-cig use (both p < .05). In sum, compared with placebo e-cigs, nicotine e-cigs can relieve smoking abstinence symptoms, perhaps in a manner similar to Food and Drug Administration-approved nicotine replacement therapy products, although much more research with larger samples is needed. (PsycINFO Database Record (c) 2017 APA, all rights reserved).

Ozenoxacin 1% cream in the treatment of impetigo: a multicenter, randomized, placebo- and retapamulin-controlled clinical trial.

Science.gov (United States)

Gropper, Savion; Albareda, Nuria; Chelius, Klaus; Kruger, Dawie; Mitha, Ismail; Vahed, Yacoob; Gani, Mashra; García-Alonso, Fernando

2014-01-01

We compared the efficacy and safety of ozenoxacin (a new nonfluorinated quinolone) 1% cream with placebo in the treatment of impetigo. In a randomized, double-blind, multicenter study, patients received ozenoxacin cream or placebo cream twice daily for 5 days (a third group received retapamulin 1% ointment as a control). Clinical, microbiological and laboratory evaluations were performed during follow-up (over 2 weeks). Ozenoxacin was superior to placebo (success rate 34.8 vs 19.2%; p = 0.003). Microbiological success was 70.8% for ozenoxacin and 38.2% for placebo after 3-4 days and 79.2% versus 56.6% after 6-7 days. Ozenoxacin produced more rapid microbiological clearance than retapamulin. All treatments were well tolerated. Ozenoxacin 1% cream was effective and safe in the treatment of impetigo.

Educação e monitorização por telefone de pacientes com insuficiência cardíaca: ensaio clínico randomizado Educación y monitoreo por teléfono de pacientes con insuficiencia cardíaca: ensayo clínico randomizado Education and telephone monitoring by nurses of patients with heart failure: randomized clinical trial

Directory of Open Access Journals (Sweden)

Fernanda B Domingues

2011-03-01

Full Text Available FUNDAMENTO: Diferentes abordagens de enfermagem no manejo de pacientes com insuficiência cardíaca (IC tem demonstrado benefícios na redução da morbidade e mortalidade. Entretanto, a combinação de educação intra-hospitalar com contato telefônico após a alta hospitalar tem sido pouco explorada. OBJETIVO: Comparar dois grupos de intervenção de enfermagem entre pacientes hospitalizados devido à IC descompensada: o grupo intervenção (GI recebeu intervenção educativa de enfermagem durante a hospitalização, seguida de monitorização por telefone após a alta hospitalar e o grupo controle (GC recebeu apenas a intervenção hospitalar. Os desfechos foram conhecimento da IC e autocuidado, número de visitas à emergência, re-hospitalizações e morte em um período de três meses. MÉTODOS: Ensaio clínico randomizado. Pacientes adultos com IC e fração de ejeção do ventrículo esquerdo (FEVE FUNDAMENTO: Diferentes abordajes de enfermería en el manejo de pacientes con insuficiencia cardíaca (IC han demostrado beneficios en la reducción de la morbilidad y mortalidad. Entre tanto, la combinación de educación intrahospitalaria con contacto telefónico después del alta hospitalaria ha sido poco explorada. OBJETIVO: Comparar dos grupos de intervención de enfermería entre pacientes hospitalizados debido a IC descompensada: el grupo intervención (GI recibió intervención educativa de enfermería durante la hospitalización, seguida de monitoreo por teléfono después del alta hospitalaria y el grupo control (GC recibió apenas la intervención hospitalaria. Los desenlaces fueron conocimiento de IC y autocuidado, número de visitas a la emergencia, rehospitalizaciones y muerte en un período de tres meses. MÉTODOS: Ensayo clínico randomizado. Pacientes adultos con IC y fracción de eyección del ventrículo izquierdo (FEVI BACKGROUND: Nursing approaches to manage patients with heart failure (HF showed benefits in reducing the

A placebo-controlled comparison of ketamine with pethidine for the ...

African Journals Online (AJOL)

Southern African Journal of Anaesthesia and Analgesia ... of ketamine when compared with pethidine and placebo for the prevention of postanaesthetic shivering. ... Pain was assessed and recorded by means of a visual analogue scale.

A double-blind placebo-controlled randomized trial of adalimumab in the treatment of hidradenitis suppurativa

DEFF Research Database (Denmark)

Miller, I; Lynggaard, C D; Lophaven, S

2011-01-01

BACKGROUND: Hidradenitis suppurativa (HS) has an impact on patients' quality of life. Treatment of HS is generally unsatisfactory, thus new treatments are needed. OBJECTIVES: To test the efficacy of adalimumab in HS. METHODS: This was a prospective, randomized, double-blinded, placebo-controlled,......BACKGROUND: Hidradenitis suppurativa (HS) has an impact on patients' quality of life. Treatment of HS is generally unsatisfactory, thus new treatments are needed. OBJECTIVES: To test the efficacy of adalimumab in HS. METHODS: This was a prospective, randomized, double-blinded, placebo......-controlled, two-centre clinical trial conducted in Denmark. Inclusion criteria were age above 18 years and a clinical diagnosis of moderate to severe HS defined as Hurley stage II or III for at least 6 months. The patients were randomized 1:2 (placebo/active). Actively treated patients received adalimumab 80 mg...... subcutaneously (s.c.) at baseline followed by 40 mg s.c. every other week for 12 weeks. Placebo-treated patients received identical-looking injections with no active ingredient. The medicine was dispensed in sequentially numbered computer-randomized containers. Participants, care givers and those assessing...

Duloxetine in the treatment of binge eating disorder with depressive disorders: a placebo-controlled trial.

Science.gov (United States)

Guerdjikova, Anna I; McElroy, Susan L; Winstanley, Erin L; Nelson, Eric B; Mori, Nicole; McCoy, Jessica; Keck, Paul E; Hudson, James I

2012-03-01

This study evaluated duloxetine in the treatment of binge eating disorder (BED) with comorbid current depressive disorders. In this 12-week, double-blind, placebo-controlled trial, 40 patients with Diagnostic and Statistical Manual of Mental Disorders-IV-TR BED and a comorbid current depressive disorder received duloxetine (N = 20) or placebo (N = 20). The primary outcome measure was weekly binge eating day frequency. In the primary analysis, duloxetine (mean 78.7 mg/day) was superior to placebo in reducing weekly frequency of binge eating days (p = .04), binge eating episodes (p = .02), weight (p = .04), and Clinical Global Impression-Severity of Illness ratings for binge eating (p = .02) and depressive disorders (p = .01). Changes in body mass index and measures of eating pathology, depression, and anxiety did not differ between the two groups. Duloxetine may be effective for reducing binge eating, weight, and global severity of illness in BED with a comorbid current depressive disorder, but this finding needs confirmation in larger, placebo-controlled trials. Copyright © 2011 Wiley Periodicals, Inc.

Prophylaxis of irradiation-induced Diarrhea with smectite. Results of a placebo-controlled investigation

International Nuclear Information System (INIS)

Hombrink, J.; Froehlich, D.; Glatzel, M.; Krauss, A.; Thiel, H.J.; Meier, J.; Hamann, D.; Muecke, R.; Glaser, F.H.; Koest, S.

2000-01-01

Between April 1994 and May 1995, a total of 176 patients obtaining radiotherapy of the pelvis or the abdomen were evaluated in a double-blind, randomized placebo-controlled investigation regarding the prophylactic effect of smectite (=Colina trademark ) against radiotherapy-induced diarrhea. During the whole period of radiotherapy 85 patients obtained 2x6 g smectite daily and 91 patients received 2x6 g placebo. The primary end point of the analysis was the time to the first appearance of diarrhea (≥3 pappy stools). Results: All 176 patients were evaluated according to an intent-to-treat analysis. There was no significant difference between the prophylactic effects of smectite and placebo. For an explorative post-hoc analysis the total study group was split up into 2 subgroups, one with an irradiated small bowel volume ≤837.5 ml, the other with a small bowel volume >837.5 ml (median); the analysis indicated that the first subgroup showed a benefit for the smectite-treated patients in contrast to the placebo treatment (32 vs. 18 calendar days to the first appearance of diarrhea). This benefit was statistically not significant. Conclusion: Prophylactic application of smectite during irradiation of the pelvis and the abdomen can delay the development of radiotherapy-induced diarrhea, a statistical significance could not be verified neither in the total study group nor in the post-hoc subgroup analysis. (orig.) [de

The psychological behaviorism theory of pain and the placebo: its principles and results of research application.

Science.gov (United States)

Staats, Peter S; Hekmat, Hamid; Staats, Arthur W

2004-01-01

The psychological behaviorism theory of pain unifies biological, behavioral, and cognitive-behavioral theories of pain and facilitates development of a common vocabulary for pain research across disciplines. Pain investigation proceeds in seven interacting realms: basic biology, conditioned learning, language cognition, personality differences, pain behavior, the social environment, and emotions. Because pain is an emotional response, examining the bidirectional impact of emotion is pivotal to understanding pain. Emotion influences each of the other areas of interest and causes the impact of each factor to amplify or diminish in an additive fashion. Research based on this theory of pain has revealed the ameliorating impact on pain of (1) improving mood by engaging in pleasant sexual fantasies, (2) reducing anxiety, and (3) reducing anger through various techniques. Application of the theory to therapy improved the results of treatment of osteoarthritic pain. The psychological behaviorism theory of the placebo considers the placebo a stimulus conditioned to elicit a positive emotional response. This response is most powerful if it is elicited by conditioned language. Research based on this theory of the placebo that pain is ameliorated by a placebo suggestion and augmented by a nocebo suggestion and that pain sensitivity and pain anxiety increase susceptibility to a placebo.

Antioxidative Activity of Onion Peel Extract in Obese Women: A Randomized, Double-blind, Placebo Controlled Study.

Science.gov (United States)

Kim, Kyung-Ah; Yim, Jung-Eun

2015-09-01

Quercetin, found abundantly in onion peel, has been known to have anticholesterol, antithrombotic and insulin-sensitizing properties. Here, we investigated the effect of quercetin-rich onion peel extract (OPE) on reactive oxygen species (ROS) production and antioxidative defense in obese woman. This study was randomized, double-blind, placebo controlled study. Thirty-seven healthy obese participants were randomly assigned that eighteen subjects received red soft capsuled OPE (100 mg/d, 50 mg bis in die), while the other nineteen subjects received same capsuled placebo for 12 weeks. ROS production and superoxide dismutase (SOD) activity in plasma were determined by using ROS and SOD assay kits, respectively. Baseline characteristics of anthropometric indicators and blood metabolic profiles were not significantly different between the two groups. Compared with baseline values, OPE consumption significantly reduced waist and hip circumference. Plasma ROS level and SOD activity were decreased in both placebo and OPE groups compared with baseline values. However, plasma ROS level in OPE group was significantly lower than in placebo group while plasma SOD activity in OPE group was significantly higher than in placebo group after 12 weeks of consumption. These findings indicate that OPE consumption may exert antioxidative effect by preventing the decrease of SOD activity as well as the production of ROS in obese women.

Placebo substitution for tnethyldopa in geriatric hypertensive patients

African Journals Online (AJOL)

and the benefit of treatment is still disputed.6 The aim of this study was to substitute a matching placebo for methyldopa in order to evaluate the effect of removal of a drug from the antihypertensive regimen of elderly patients without concomitantly inducing a sense of in- security. Sex (female/male) 16/2. Mean age (yrs). 75,7.

A double-blind, placebo controlled trial of high-dose lecithin in Alzheimer's disease.

OpenAIRE

Little, A; Levy, R; Chuaqui-Kidd, P; Hand, D

1985-01-01

The first long-term double-blind placebo controlled trial of high dose lecithin in senile dementia of the Alzheimer type is reported. Fifty one subjects were given 20-25 g/day of purified soya lecithin (containing 90% phosphatidyl plus lysophosphatidyl choline) for six months and followed up for at least a further six months. Plasma choline levels were monitored throughout the treatment period. There were no differences between the placebo group and the lecithin group but there was an improve...

A double-blind placebo-controlled study of controlled release fluvoxamine for the treatment of generalized social anxiety disorder.

Science.gov (United States)

Westenberg, Herman G M; Stein, Dan J; Yang, Haichen; Li, David; Barbato, Luigi M

2004-02-01

This was a randomized double-blind placebo-controlled multicenter study to assess the efficacy, safety, and tolerability of fluvoxamine in a controlled release (CR) formulation for treatment of generalized social anxiety disorder (GSAD). A total of 300 subjects with GSAD were randomly assigned to receive either fluvoxamine CR (N = 149) or placebo (N = 151) for 12 weeks. Mean changes from baseline to end point in Liebowitz Social Anxiety Scale (LSAS), Clinical Global Impression Severity of Illness Scale (CGI-S), Sheehan Disability Scale (SDS), as well as the mean end point scores in Clinical Global Impression Improvement Scale (CGI-I) and Patient Global Impression of Improvement Scale (PGI) were compared between the fluvoxamine CR and placebo treatment groups. Arizona Sexual Experience Scale (ASEX), adverse event, and other safety parameters were also assessed. The results demonstrated that fluvoxamine CR was significantly superior to placebo in decreasing LSAS total score (primary measure) starting at week 4. At end point, there was a mean change from baseline of -36.1 +/- 2.7 (37% reduction) in the LSAS total score in the fluvoxamine CR group compared with -27.3 +/- 2.4 (28% reduction) in the placebo group (P = 0.020 for mean change). Fluvoxamine CR was also significantly superior to placebo in SDS, CGI-S, CGI-I at end point (secondary measures). When compared with placebo, fluvoxamine CR did not cause any significant weight gain or clinically significant sexual dysfunction as measured by ASEX. In summary, fluvoxamine CR is an efficacious, safe, and well-tolerated treatment of generalized social anxiety disorder.

Randomized, double-blind, placebo-controlled trial of fluoxetine treatment for elderly patients with dysthymic disorder.

Science.gov (United States)

Devanand, D P; Nobler, Mitchell S; Cheng, Jocelyn; Turret, Nancy; Pelton, Gregory H; Roose, Steven P; Sackeim, Harold A

2005-01-01

The authors compared the efficacy and side effects of fluoxetine and placebo in elderly outpatients with dysthymic disorder. Patients were randomly assigned to fluoxetine (20 mg-60 mg/day) or placebo for 12 weeks in a double-blind trial. Of 90 randomized patients, 71 completed the trial. In the intent-to-treat sample, random regression analyses of the Hamilton Rating Scale for Depression (Ham-D; 24-item) and Cornell Dysthymia Rating Scale (CDRS) scores at each visit produced significant time x treatment group interactions favoring the fluoxetine group. Analysis of percentage change in Ham-D scores yielded no effect for treatment group, but a similar analysis of percentage change in CDRS scores yielded a main effect for treatment group, favoring fluoxetine over placebo. In the intent-to-treat sample, response rates were 27.3% for fluoxetine and 19.6% for placebo. In the completer sample, response rates were 37.5% for fluoxetine and 23.1% for placebo. Fluoxetine had limited efficacy in elderly dysthymic patients. The clinical features of elderly dysthymic patients are typically distinct from those of dysthymic disorder in young adults, and the findings suggest that treatments effective for young adult dysthymic patients may not be as useful in elderly dysthymic patients. Further research is needed to identify efficacious treatments for elderly patients with dysthymic disorder, and investigative tools such as electronic/computerized brain scans and neuropsychological testing may help identify the factors that moderate antidepressant treatment response and resistance.

A Randomized Double-blind Placebo-controlled Trial to Assess the Effect of Tamarind seed in Premature Ejaculation

Directory of Open Access Journals (Sweden)

Abdulla Homayuonfar

2018-01-01

Full Text Available Background: This randomized clinical trial was aimed to evaluate the effect of oral use of tamarind seed powder as an herbal product in patients affected by premature ejaculation (PE. Materials and Methods: In this study, 75 patients randomized in tamarind group (25 patients received daily 130 mg tamarind seed powder, paroxetine group (25 patients received daily 20 mg paroxetine, and placebo group (25 patients. Patients received the treatment regimen for 4 weeks. The primary outcome was intravaginal ejaculatory latency time (IELT. The secondary outcomes were PE diagnostic tool score, sexual function using International Index of Erectile Function (IIEF, and complications. Studied sexual functions include erectile function, orgasmic function, sexual desire, intercourse satisfaction, and overall satisfaction. Results: The mean of IELT in tamarind, paroxetine, and placebo groups at baseline was 35.2 ± 26.5, 38 ± 27.6, and 44 ± 34.9 s and at the end of study was 49.5 ± 48.2, 147.4 ± 209.6, and 46.9 ± 37.6 s, respectively, which in paroxetine group significantly increased compared to other groups. IIEF scores for orgasmic function and intercourse satisfaction for paroxetine after treatment significantly increased than that of other groups. The differences between tamarind and placebo groups for studied variables were not statistically significant. The mean of increases in IELT for tamarind, paroxetine, and placebo groups was 14.35 ± 34.3, 109.4 ± 213.4, and 2.9 ± 9.3 s, respectively, which in paroxetine group was significantly higher than other groups and in tamarind group was significantly higher than placebo. Conclusions: Paroxetine was significantly better than tamarind seed powder and placebo although side effect in paroxetine was more frequent. IELT significantly more increased in tamarind group compared to placebo.

Effect of Zingiber officinale R. rhizomes (ginger on pain relief in primary dysmenorrhea: a placebo randomized trial

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Rahnama Parvin

2012-07-01

Full Text Available Abstract Background Zingiber officinale R. rhizome (ginger is a popular spice that has traditionally been used to combat the effects of various inflammatory diseases. The aim of this study was to evaluate the effects of ginger on pain relief in primary dysmenorrhea. Method This was a randomized, controlled trial. The study was based on a sample of one hundred and twenty students with moderate or severe primary dysmenorrhea. The students were all residents of the dormitories of Shahed University. They were randomly assigned into two equal groups, one for ginger and the other for placebo in two different treatment protocols with monthly intervals. The ginger and placebo groups in both protocols received 500 mg capsules of ginger root powder or placebo three times a day. In the first protocol ginger and placebo were given two days before the onset of the menstrual period and continued through the first three days of the menstrual period. In the second protocol ginger and placebo were given only for the first three days of the menstrual period. Severity of pain was determined by a verbal multidimensional scoring system and a visual analogue scale. Results There was no difference in the baseline characteristics of the two groups (placebo n = 46, ginger n = 56. The results of this study showed that there were significant differences in the severity of pain between ginger and placebo groups for protocol one (P = 0.015 and protocol two (P = 0.029. There was also significant difference in duration of pain between the two groups for protocol one (P = 0.017 but not for protocol two (P = 0.210. Conclusion Treatment of primary dysmenorrhea in students with ginger for 5 days had a statistically significant effect on relieving intensity and duration of pain. Trial registration IRCT201105266206N3

A Randomized, Double-Blind, Placebo-Controlled Trial of Pleconaril for the Treatment of Neonates With Enterovirus Sepsis.

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Abzug, Mark J; Michaels, Marian G; Wald, Ellen; Jacobs, Richard F; Romero, José R; Sánchez, Pablo J; Wilson, Gregory; Krogstad, Paul; Storch, Gregory A; Lawrence, Robert; Shelton, Mark; Palmer, April; Robinson, Joan; Dennehy, Penelope; Sood, Sunil K; Cloud, Gretchen; Jester, Penelope; Acosta, Edward P; Whitley, Richard; Kimberlin, David

2016-03-01

Neonatal enterovirus sepsis has high mortality. Antiviral therapy is not available. Neonates with suspected enterovirus sepsis (hepatitis, coagulopathy, and/or myocarditis) with onset at ≤15 days of life were randomized 2:1 to receive oral pleconaril or placebo for 7 days. Serial virologic (oropharynx, rectum, urine, serum), clinical, pharmacokinetic, and safety evaluations were performed. Sixty-one subjects were enrolled (43 treatment, 18 placebo), of whom 43 were confirmed enterovirus infected (31 treatment, 12 placebo). There was no difference in day 5 oropharyngeal culture positivity (primary endpoint; 0% in both groups). However, enterovirus-infected subjects in the treatment group became culture negative from all anatomic sites combined faster than placebo group subjects (median 4.0 versus 7.0 days, P = .08), and fewer subjects in the treatment group remained polymerase chain reaction (PCR)-positive from the oropharynx when last sampled (23% versus 58%, P = .02; median, 14.0 days). By intent to treat, 10/43 (23%) subjects in the treatment group and 8/18 (44%) in the placebo group died (P = .02 for 2-month survival difference); among enterovirus-confirmed subjects, 7/31 (23%) in the treatment group died versus 5/12 (42%) in the placebo group (P = .26). All pleconaril recipients attained concentrations greater than the IC90 after the first study day, but 38% were less than the IC90 during the first day of treatment. One subject in the treatment group and three in the placebo group had treatment-related adverse events. Shorter times to culture and PCR negativity and greater survival among pleconaril recipients support potential efficacy and warrant further evaluation. © The Author 2015. Published by Oxford University Press on behalf of the Pediatric Infectious Diseases Society. All rights reserved. For Permissions, please e-mail: journals.permissions@oup.com.

Tofacitinib in patients with ankylosing spondylitis: a phase II, 16-week, randomised, placebo-controlled, dose-ranging study.

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van der Heijde, Désirée; Deodhar, Atul; Wei, James C; Drescher, Edit; Fleishaker, Dona; Hendrikx, Thijs; Li, David; Menon, Sujatha; Kanik, Keith S

2017-08-01

To compare efficacy and safety of various doses of tofacitinib, an oral Janus kinase inhibitor, with placebo in patients with active ankylosing spondylitis (AS, radiographic axial spondyloarthritis). In this 16-week (12-week treatment, 4-week washout), phase II, multicentre, dose-ranging trial, adult patients with active AS were randomised (N=51, 52, 52, 52, respectively) to placebo or tofacitinib 2, 5 or 10 mg twice daily. The primary efficacy endpoint was Assessment of SpondyloArthritis International Society 20% improvement (ASAS20) response rate at week 12. Secondary endpoints included objective measures of disease activity, patient-reported outcomes and MRI of sacroiliac joints and spine. Safety was monitored. Emax model analysis of the primary endpoint predicted a tofacitinib 10 mg twice daily ASAS20 response rate of 67.4%, 27.3% higher than placebo. Supportive normal approximation analysis demonstrated tofacitinib 5 mg twice daily ASAS20 response rate significantly higher than placebo (80.8% vs 41.2%; ptofacitinib 2 and 10 mg twice daily demonstrated greater response rate than placebo (51.9% and 55.8%, respectively; not significant). Secondary endpoints generally demonstrated greater improvements with tofacitinib 5 and 10 mg twice daily than placebo. Objective (including MRI) endpoints demonstrated clear dose response. Adverse events were similar across treatment groups with no unexpected safety findings. Dose-dependent laboratory outcome changes returned close to baseline by week 16. Tofacitinib 5 and 10 mg twice daily demonstrated greater clinical efficacy versus placebo in reducing signs, symptoms and objective endpoints of active AS in adult patients with a similar 12-week safety profile as reported in other indications. NCT01786668. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.

Efficacy and Safety of Drotaverine Hydrochloride in Children with Recurrent Abdominal Pain: A Randomized Placebo Controlled Trial.

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Narang, Manish; Shah, Dheeraj; Akhtar, Hina

2015-10-01

To evaluate the efficacy and safety of Drotaverine hydrochroride in children with recurrent abdominal pain. Double blind, randomized placebo-controlled trial. Pediatric Gastroenterology clinic of a teaching hospital. 132 children (age 4-12 y) with recurrent abdominal pain (Apley Criteria) randomized to receivedrotaverine (n=66) or placebo (n=66) orally. Children between 4-6 years of age received 10 mL syrup orally (20 mg drotaverine hydrochloride or placebo) thrice daily for 4 weeks while children >6 years of age received one tablet orally (40 mg drotaverine hydrochloride or placebo) thrice daily for 4 weeks. Primary: Number of episodes of pain during 4 weeks of use of drug/placebo and number of pain-free days. Secondary: Number of school days missed during the study period, parental satisfaction (on a Likert scale), and occurrence of solicited adverse effects. Reduction in number of episodes of abdominal pain [mean (SD) number of episodes 10.3 (14) vs 21.6 (32.4); P=0.01] and lesser school absence [mean (SD) number of school days missed 0.25 (0.85) vs 0.71 (1.59); P=0.05] was noticed in children receiving drotaverine in comparison to those who received placebo. The number of pain-free days, were comparable in two groups [17.4 (8.2) vs 15.6 (8.7); P=0.23]. Significant improvement in parental satisfaction score was noticed on Likert scale by estimation of mood, activity, alertness, comfort and fluid intake. Frequency of adverse events during follow-up period was comparable between children receiving drotaverine or placebo (46.9% vs 46.7%; P=0.98). Drotaverine hydrochloride is an effective and safe pharmaceutical agent in the management of recurrent abdominal pain in children.

The Placebo Response in Pediatric Abdominal Pain-Related Functional Gastrointestinal Disorders: A Systematic Review and Meta-Analysis.

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Hoekman, Daniël R; Zeevenhooven, Judith; van Etten-Jamaludin, Faridi S; Douwes Dekker, Iuke; Benninga, Marc A; Tabbers, Merit M; Vlieger, Arine M

2017-03-01

To investigate the magnitude and determinants of the placebo response in studies with pediatric abdominal pain-related functional gastrointestinal disorders. The Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE, and CINAHL were searched for systematic reviews and randomized placebo-controlled trials concerning children 4-18 years of age with an abdominal pain-related functional gastrointestinal disorder. The primary outcome was the pooled proportion of subjects assigned to placebo with improvement as defined by the authors. The effect of trial characteristics on the magnitude of the placebo response was investigated using univariate meta-regression analysis. Twenty-one trials were identified. The pooled proportion of subjects with improvement was 41% (95% CI, 34%-49%; 17 studies) and with no pain was 17% (95% CI, 8%-32%; 7 studies). The pooled standardized mean difference on the Faces Pain Scales compared with baseline was -0.73 (95% CI, -1.04 to -0.42; 8 studies). There was significant heterogeneity across studies with respect to both outcomes. Lower dosing frequency (P = .04), positive study (P = .03), longer duration of treatment (P pain. Response on Faces Pain Scales was greater in studies conducted in the Middle East (P = .002), in studies that did not report the randomization schedule (P = .02), and in studies with a higher percentage of females (P = .04). Approximately 41% of children with abdominal pain-related functional gastrointestinal disorders improve on placebo. Several trial characteristics are correlated significantly with the proportion of patients with no pain on placebo and with the magnitude of the placebo response on Faces Pain Scales. These data could be valuable for the design of future studies. Copyright © 2016 Elsevier Inc. All rights reserved.

Moderation of Nicotine Effects on Covert Orienting of Attention Tasks by Poor Placebo Performance and Cue Validity

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Gilbert, David G.; Rzetelny, Adam; Rabinovich, Norka E.

2016-01-01

Introduction and Rationale Given baseline-dependent effects of nicotine on other forms of attention, there is reason to believe that inconsistent findings for the effects of nicotine on attentional orienting may be partly due to individual differences in baseline (abstinence state) functioning. Individuals with low baseline attention may benefit more from nicotine replacement. Method The effects of nicotine as a function of baseline performance (bottom, middle, and top third of mean reaction times during placebo) were assessed in 52 habitual abstinent smokers (26 females/26 males) utilizing an arrow-cued covert orienting of attention task. Results Compared to a placebo patch, a 14 mg nicotine patch produced faster overall reaction times (RTs). In addition, individuals with slower RTs during the placebo condition benefitted more from nicotine on cued trials than did those who had shorter (faster) RTs during placebo. Nicotine also enhanced the validity effect (shorter RTs to validly vs. invalidly cued targets), but this nicotine benefit did not differ as a function of overall placebo-baseline performance. Conclusions These findings support the view that nicotine enhances cued spatial attentional orienting in individuals who have slower RTs during placebo (nicotine-free) conditions; however, baseline-dependent effects may not generalize to all aspects of spatial attention. These findings are consistent with findings indicating that nicotine’s effects vary as a function of task parameters rather than simple RT speeding or cognitive enhancement. PMID:27461547

Exposure–response model for sibutramine and placebo: suggestion for application to long-term weight-control drug development

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Han, Seunghoon; Jeon, Sangil; Hong, Taegon; Lee, Jongtae; Bae, Soo Hyeon; Park, Wan-su; Park, Gab-jin; Youn, Sunil; Jang, Doo Yeon; Kim, Kyung-Soo; Yim, Dong-Seok

2015-01-01

No wholly successful weight-control drugs have been developed to date, despite the tremendous demand. We present an exposure–response model of sibutramine mesylate that can be applied during clinical development of other weight-control drugs. Additionally, we provide a model-based evaluation of sibutramine efficacy. Data from a double-blind, randomized, placebo-controlled, multicenter study were used (N=120). Subjects in the treatment arm were initially given 8.37 mg sibutramine base daily, and those who lost sibutramine, including the placebo effect, were modeled using NONMEM 7.2. An asymptotic model approaching the final body weight was chosen to describe the time course of weight loss. Extent of weight loss was described successfully using a sigmoidal exposure–response relationship of the drug with a constant placebo effect in each individual. The placebo effect was influenced by subjects’ sex and baseline body mass index. Maximal weight loss was predicted to occur around 1 year after treatment initiation. The difference in mean weight loss between the sibutramine (daily 12.55 mg) and placebo groups was predicted to be 4.5% in a simulation of 1 year of treatment, with considerable overlap of prediction intervals. Our exposure–response model, which included the placebo effect, is the first example of a quantitative model that can be used to predict the efficacy of weight-control drugs. Similar approaches can help decision-making during clinical development of novel weight-loss drugs. PMID:26392753

Exposure-response model for sibutramine and placebo: suggestion for application to long-term weight-control drug development.

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Han, Seunghoon; Jeon, Sangil; Hong, Taegon; Lee, Jongtae; Bae, Soo Hyeon; Park, Wan-su; Park, Gab-jin; Youn, Sunil; Jang, Doo Yeon; Kim, Kyung-Soo; Yim, Dong-Seok

2015-01-01

No wholly successful weight-control drugs have been developed to date, despite the tremendous demand. We present an exposure-response model of sibutramine mesylate that can be applied during clinical development of other weight-control drugs. Additionally, we provide a model-based evaluation of sibutramine efficacy. Data from a double-blind, randomized, placebo-controlled, multicenter study were used (N=120). Subjects in the treatment arm were initially given 8.37 mg sibutramine base daily, and those who lost sibutramine, including the placebo effect, were modeled using NONMEM 7.2. An asymptotic model approaching the final body weight was chosen to describe the time course of weight loss. Extent of weight loss was described successfully using a sigmoidal exposure-response relationship of the drug with a constant placebo effect in each individual. The placebo effect was influenced by subjects' sex and baseline body mass index. Maximal weight loss was predicted to occur around 1 year after treatment initiation. The difference in mean weight loss between the sibutramine (daily 12.55 mg) and placebo groups was predicted to be 4.5% in a simulation of 1 year of treatment, with considerable overlap of prediction intervals. Our exposure-response model, which included the placebo effect, is the first example of a quantitative model that can be used to predict the efficacy of weight-control drugs. Similar approaches can help decision-making during clinical development of novel weight-loss drugs.

Effectiveness of tamsulosin in prevention of post-operative urinary retention: a randomized double-blind placebo-controlled study.

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Madani, Ali Hamidi; Aval, Hamidreza Baghani; Mokhtari, Gholamreza; Nasseh, Hamidreza; Esmaeili, Samaneh; Shakiba, Maryam; Shakiba, Reza Shahrokhi; Seyed Damavand, Seyed Mohamad

2014-01-01

Urinary retention is one of the most common complications contributing to surgical procedures. Recent studies have shown the benefits of alpha-adrenergic blockers in preventing post-operative urinary retention (POUR). The aim of this prospective study was to compare the prophylactic effect of tamsulosin with placebo on postoperative urinary retention. In this randomized placebo controlled, clinical trial, 232 male patients aged 18 to 50 years old admitted to Razi University Hospital for varicocelectomy, inguinal herniorrhaphy, and scrotal surgery were randomly assigned to receive either three doses of 0.4mg tamsulosin (n = 118) or placebo (n = 114), 14 and 2 hours before, and 10 hours after surgery. Patients were closely monitored for the development of urinary retention 24 hours after surgical intervention. The primary endpoint was to investigate the effect of tamsulosin in prevention of post-operative urinary retention during the first 24 hours after surgical intervention. Collected data were analyzed using SPSS software version 18 and the P tamsulosin arm and 114 in placebo arm. POUR in patients who received tamsulosin was significantly lower than placebo, as 5.9% of the patients treated with tamsulosin and 21.1% placebo group, reported urinary retention following surgery (P = 0.001). No serious adverse effects were seen in both groups. This study suggests that short perioperative treatment with tamsulosin can reduce the incidence of urinary retention and the need for catheterization after varicocelectomy, inguinal herniorrhaphy, and scrotal surgery.

Improving depression and enhancing resilience in family dementia caregivers: a pilot randomized placebo-controlled trial of escitalopram.

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Lavretsky, Helen; Siddarth, Prabha; Irwin, Michael R

2010-02-01

This study examined the potential of an antidepressant drug, escitalopram, to improve depression, resilience to stress, and quality of life in family dementia caregivers in a randomized placebo-controlled double-blinded trial. Forty family caregivers (43-91 years of age, 25 children and 15 spouses; 26 women) who were taking care of their relatives with Alzheimer disease were randomized to receive either escitalopram 10 mg/day or placebo for 12 weeks. Severity of depression, resilience, burden, distress, quality of life, and severity of care-recipient's cognitive and behavioral disturbances were assessed at baseline and over the course of the study. The Hamilton Depression Rating Scale scores at baseline ranged between 10 and 28. The groups were stratified by the diagnosis of major and minor depression. Most outcomes favored escitalopram over placebo. The severity of depression improved, and the remission rate was greater with the drug compared with placebo. Measures of anxiety, resilience, burden, and distress improved on escitalopram compared with placebo. Among caregivers, this small randomized controlled trial found that escitalopram use resulted in improvement in depression, resilience, burden and distress, and quality of life. Our results need to be confirmed in a larger sample.

[Effect of Xinling Wan in treatment of stable angina pectoris: a randomized, double-blinded, placebo parallel-controlled, multicenter trial].

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Gao, Jian-Wei; Gao, Xue-Min; Zou, Ting; Zhao, Tian-Meng; Wang, Dong-Hua; Wu, Zong-Gui; Ren, Chang-Jie; Wang, Xing; Geng, Nai-Zhi; Zhao, Ming-Jun; Liang, Qiu-Ming; Feng, Xing; Yang, Bai-Song; Shi, Jun-Ling; Hua, Qi

2018-03-01

To evaluate the effectiveness and safety of Xinling Wan on patients with stable angina pectoris, a randomized, double-blinded, placebo parallel-controlled, multicenter clinical trial was conducted. A total of 232 subjects were enrolled and randomly divided into experiment group and placebo group. The experiment group was treated with Xinling Wan (two pills each time, three times daily) for 4 weeks, and the placebo group was treated with placebo. The effectiveness evaluation showed that Xinling Wan could significantly increase the total duration of treadmill exercise among patients with stable angina pectoris. FAS analysis showed that the difference value of the total exercise duration was between experiment group (72.11±139.32) s and placebo group (31.25±108.32) s. Xinling Wan could remarkably increase the total effective rate of angina pectoris symptom score, and the analysis showed that the total effective rate was 78.95% in experiment group and 42.61% in placebo group. The reduction of nitroglycerin dose was (2.45±2.41) tablets in experiment group and (0.50±2.24) tablets in placebo group on the basis of FAS analysis. The decrease of symptom integral was (4.68±3.49) in experiment group and (3.19±3.31) in placebo group based on FAS analysis. Besides, Xinling Wan could decrease the weekly attack time and the duration of angina pectoris. PPS analysis results were similar to those of FAS analysis. In conclusion, Xinling Wan has an obvious therapeutic effect in treating stable angina pectoris, with a good safety and a low incidence of adverse event and adverse reaction in experiment group. Copyright© by the Chinese Pharmaceutical Association.

Methylphenidate and Memory and Attention Adaptation Training for Persistent Cognitive Symptoms after Traumatic Brain Injury: A Randomized, Placebo-Controlled Trial.

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McDonald, Brenna C; Flashman, Laura A; Arciniegas, David B; Ferguson, Robert J; Xing, Li; Harezlak, Jaroslaw; Sprehn, Gwen C; Hammond, Flora M; Maerlender, Arthur C; Kruck, Carrie L; Gillock, Karen L; Frey, Kim; Wall, Rachel N; Saykin, Andrew J; McAllister, Thomas W

2017-08-01

The purpose of this multicenter, prospective, randomized, placebo-controlled study was to evaluate and compare the efficacy of two cognitive rehabilitation interventions (Memory and Attention Adaptation Training (MAAT) and Attention Builders Training (ABT)), with and without pharmacological enhancement (ie, with methylphenidate (MPH) or placebo), for treating persistent cognitive problems after traumatic brain injury (TBI). Adults with a history of TBI at least 4 months before study enrollment with either objective cognitive deficits or subjective cognitive complaints were randomized to receive MPH or placebo and MAAT or ABT, yielding four treatment combinations: MAAT/MPH (N=17), ABT/MPH (N=19), MAAT/placebo (N=17), and ABT/placebo (N=18). Assessments were conducted pre-treatment (baseline) and after 6 weeks of treatment (post treatment). Outcome measures included scores on neuropsychological measures and subjective rating scales. Statistical analyses used linear regression models to predict post-treatment scores for each outcome variable by treatment type, adjusting for relevant covariates. Statistically significant (PABT/placebo), nonverbal learning (MAAT/MPH>MAAT/placebo and MAAT/MPH>ABT/MPH), and auditory working memory and divided attention (MAAT/MPH>ABT/MPH). These results suggest that combined treatment with metacognitive rehabilitation (MAAT) and pharmacotherapy (MPH) can improve aspects of attention, episodic and working memory, and executive functioning after TBI.

Response Expectancy and the Placebo Effect.

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Kirsch, Irving

2018-01-01

In this chapter, I review basic tenets of response expectancy theory (Kirsch, 1985), beginning with the important distinction between response expectancies and stimulus expectancies. Although both can affect experience, the effects of response expectancies are stronger and more resistant to extinction than those of stimulus expectancies. Further, response expectancies are especially important to understanding placebo effects. The response expectancy framework is consistent with and has been amplified by the Bayesian model of predictive coding. Clinical implications of these phenomena are exemplified. © 2018 Elsevier Inc. All rights reserved.

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

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Puviani, Luca; Rama, Sidita

2016-07-20

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 the response to substance intake. It is shown that placebo response can be conceptualized as a reaction of a distributed neural system within the central nervous system. Such a reaction represents an integrated component of the response to open substance administration (or to substance intake) and is updated through "unconditioned stimulus (UCS) revaluation learning". The analysis leads to a theorem, which proves the existence of two distinct quantities coded within the brain, these are the expected or prediction outcome and the reactive response. We show that the reactive response is updated automatically by implicit revaluation learning, while the expected outcome can also be modulated through conscious information processing. Conceptualizing the response to substance intake in terms of UCS revaluation learning leads to the theoretical formulation of a potential neuropharmacological treatment for increasing unlimitedly the effectiveness of a given drug.

The subtle central effect of nutraceuticals: Is it placebo or nocebo?

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Ali I. Al-Gareeb

2015-09-01

Subjects and methods: This is a randomized, double-blind, controlled, and prospective study conducted in the Department of Pharmacology, College of Medicine, Al-Mustansiriya University, Baghdad, Iraq during February 2013. One hundred sixty medical students participated in the study were randomly assigned equally to one of the following groups: Group A: received single dose of nigella sativa oil (500 ml capsule;Group B: received single dose of garlic (500 mg capsule; Group C: received single dose of Coq10 (120 mg capsule and; Group D: received single dose of matching oral placebo (300mg starchc capsule. For all participants, reaction time and flicker fusion threshold were measured by the Leeds psychomotor performance test battery before and after 3 hours of taking the drugs Results: Neither placebo nor nutraceuticals exerted significant effect on total reaction time. Although the recognition reaction time is insignificantly reduced by 2.77% (placebo, 5.83% (Nigella savita, 7.21% (Garlic and 12.64% (CoQ10 from the pretreatment values, they are adversely affect the motor reaction time to reach the significant level in subjects pretreated with Garlic (p=0.02. Conclusion: Nutraceuticals are not free from nocebo effect on psychomotor performance. [J Intercult Ethnopharmacol 2015; 4(3.000: 221-223

A Bayesian perspective on sensory and cognitive integration in pain perception and placebo analgesia.

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Davide Anchisi

Full Text Available The placebo effect is a component of any response to a treatment (effective or inert, but we still ignore why it exists. We propose that placebo analgesia is a facet of pain perception, others being the modulating effects of emotions, cognition and past experience, and we suggest that a computational understanding of pain may provide a unifying explanation of these phenomena. Here we show how Bayesian decision theory can account for such features and we describe a model of pain that we tested against experimental data. Our model not only agrees with placebo analgesia, but also predicts that learning can affect pain perception in other unexpected ways, which experimental evidence supports. Finally, the model can also reflect the strategies used by pain perception, showing that modulation by disparate factors is intrinsic to the pain process.

Umeclidinium bromide versus placebo for people with chronic obstructive pulmonary disease (COPD).