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Int. arch. otorhinolaryngol. (Impr.) ; 24(1): 62-67, Jan.-Mar. 2020. tab, graf
Article in English | LILACS | ID: biblio-1090549


Abstract Introduction Posttonsillectomy pain results in significant morbidity to the patients. There is a disagreement in the literature regarding the use of local anesthetics during tonsillectomy. The aim of this placebo-controlled, double-blind study is to evaluate the effect of peritonsillar administration of local anesthetics. Objective To evaluate the role of intraoperative use of analgesics in tonsillar fossa and postoperative evaluation with visual analogue scale (VAS) scores in achieving pain relief after tonsillectomy procedure Methods In this study, 180 patients were randomized to 1 of the 6 groups: bupivacaine infiltration, lidocaine infiltration, normal saline infiltration, bupivacaine packing, lidocaine packing, and normal saline packing. Pain caused by speaking, swallowing, and on rest was assessed using VAS at 4, 8, 12, 16 hours, and at discharge. Results Significant analgesia was obtained in patients who received bupivacaine infiltration and packing compared with placebo (p < 0.05). The majority of the study subjects had no postoperative complications, and patients receiving bupivacaine infiltration required less additional analgesics in the first 24 hours after surgery. Conclusion We advocate the use of bupivacaine infiltration or packing immediately following the procedure to achieve adequate postoperative analgesia.

Humans , Male , Female , Child , Adolescent , Pain, Postoperative/drug therapy , Tonsillectomy , Analgesia , Analgesics/administration & dosage , Analgesics/therapeutic use , Intraoperative Care , Pain, Postoperative/diagnosis , Pain, Postoperative/prevention & control , Pakistan , Placebos/administration & dosage , Postoperative Complications , Pain Measurement/methods , Bupivacaine/administration & dosage , Bupivacaine/therapeutic use , Double-Blind Method , Prospective Studies , Injections, Intravenous , Lidocaine/administration & dosage , Lidocaine/therapeutic use
Rev. Hosp. Ital. B. Aires (2004) ; 40(1): 34-38, mar. 2020. tab
Article in Spanish | LILACS | ID: biblio-1102292


Las mujeres han sido tratadas por décadas con testosterona intentando aliviar una gran variedad de síntomas con riesgos y beneficios inciertos. En la mayoría de los países, la testosterona se prescribe "off-label", de modo que las mujeres están utilizando compuestos y dosis ideadas para tratamientos en hombres. En este sentido, varias sociedades médicas de distintos continentes adoptaron recientemente por consenso una toma de posición sobre los beneficios y potenciales riesgos de la terapia con testosterona en la mujer, explorar las áreas de incertidumbre e identificar prácticas de prescripción con potencial de causar daño. Las recomendaciones con respecto a los beneficios y riesgos de la terapia con testosterona se basan en los resultados de ensayos clínicos controlados con placebo de al menos 12 semanas de duración. A continuación se comentan las recomendaciones. (AU)

There are currently no clear established indications for testosterone replacement therapy for women. Nonetheless, clinicians have been treating women with testosterone to alleviate a variety of symptoms for decades with uncertainty regarding its benefits and risks. In most countries, testosterone therapy is prescribed off-label, which means that women are using testosterone formulations or compounds approved for men with a modified dose for women. Due to these issues, there was a need for a global Consensus Position Statement on testosterone therapy for women based on the available evidence from placebo randomized controlled trials (RCTs). This Position Statement was developed to inform health care professionals about the benefits and potential risks of testosterone therapy intended for women. The aim of the Consensus was to provide clear guidance as to which women might benefit from testosterone therapy; to identify symptoms, signs, and certain conditions for which the evidence does not support the prescription of testosterone; to explore areas of uncertainty, and to identify any prescribing practices that have the potential to cause harm. (AU)

Humans , Female , Aged , Testosterone/therapeutic use , Postmenopause/drug effects , Appetite Depressants/adverse effects , Phenytoin/adverse effects , Placebos/administration & dosage , Psychotropic Drugs/adverse effects , Tamoxifen/adverse effects , Testosterone/administration & dosage , Testosterone/analysis , Testosterone/adverse effects , Testosterone/pharmacology , Cardiovascular Agents/adverse effects , Indomethacin/adverse effects , Gonadotropin-Releasing Hormone/adverse effects , Postmenopause/physiology , Controlled Clinical Trials as Topic , Cholinergic Antagonists/adverse effects , Contraceptives, Oral/adverse effects , Sexual Dysfunctions, Psychological/etiology , Sexual Dysfunctions, Psychological/therapy , Danazol/adverse effects , Consensus , Aromatase Inhibitors/adverse effects , Off-Label Use , Factor Xa Inhibitors/adverse effects , Amphetamines/adverse effects , Histamine Antagonists/adverse effects , Androgen Antagonists/adverse effects , Androgens/physiology , Ketoconazole/adverse effects , Narcotics/adverse effects
J. bras. nefrol ; 41(4): 492-500, Out.-Dec. 2019. tab, graf
Article in English | LILACS | ID: biblio-1056600


Abstract Introduction: Intradialytic hypotension (IDH) is a major complication of hemodialysis, with a prevalence of about 25% during hemodialysis sessions, causing increased morbidity and mortality. Objective: To study the effects of sertraline to prevent IDH in hemodialysis patients. Methods: This was a double-blind, crossover clinical trial comparing the use of sertraline versus placebo to reduce intradialytic hypotension. Results: Sixteen patients completed the two phases of the study during a 12-week period. The IDH prevalence was 32%. A comparison between intradialytic interventions, intradialytic symptoms, and IDH episodes revealed no statistical difference in the reduction of IDH episodes (p = 0.207) between the two intervention groups. However, the risk of IDH interventions was 60% higher in the placebo group compared to the sertraline group, and the risk of IDH symptoms was 40% higher in the placebo group compared to the sertraline group. Survival analysis using Kaplan-Meier estimator supported the results of this study. Sertraline presented a number needed to treat (NNT) of 16.3 patients to prevent an episode from IDH intervention and 14.2 patients to prevent an episode from intradialytic symptoms. Conclusion: This study suggests that the use of sertraline may be beneficial to reduce the number of symptoms and ID interventions, although there was no statistically significant difference in the blood pressure levels.

Resumo Introdução: A hipotensão intradialítica (HID) é uma das principais complicações da hemodiálise, com uma prevalência de cerca de 25% durante as sessões de hemodiálise, causando aumento da morbimortalidade. Objetivo: Estudar os efeitos da sertralina na prevenção da HID em pacientes em hemodiálise. Métodos: Este foi um ensaio clínico duplo-cego, cruzado, comparando o uso de sertralina versus placebo para reduzir a hipotensão intradialítica. Resultados: Dezesseis pacientes completaram as duas fases do estudo durante um período de 12 semanas. A prevalência de HID foi de 32%. Uma comparação entre intervenções intradialíticas, sintomas intradialíticos (ID) e episódios de HID não revelou diferença estatística na redução dos episódios de HID (p = 0,207) entre os dois grupos de intervenção. No entanto, o risco de intervenções para HID foi 60% maior no grupo placebo em comparação com o grupo Sertralina, e o risco de sintomas ID foi 40% maior no grupo placebo em comparação com o grupo Sertralina. A análise de sobrevida utilizando o estimador de Kaplan-Meier corroborou os resultados deste estudo. A sertralina apresentou um número necessário para tratar (NNT) de 16,3 pacientes para prevenir um episódio de intervenção de HID e 14,2 pacientes para prevenir um episódio de sintomas intradialíticos. Conclusão: Este estudo sugere que o uso de sertralina pode ser benéfico para reduzir o número de sintomas e intervenções de HID, embora não tenha havido diferença estatisticamente significante nos níveis pressóricos.

Humans , Male , Female , Middle Aged , Aged , Renal Dialysis/adverse effects , Serotonin Uptake Inhibitors/therapeutic use , Sertraline/therapeutic use , Renal Insufficiency/therapy , Hypotension/physiopathology , Placebos/administration & dosage , Blood Pressure/drug effects , Blood Pressure/physiology , Double-Blind Method , Prevalence , Renal Dialysis/mortality , Cross-Over Studies , Renal Insufficiency/complications , Hypotension/prevention & control , Hypotension/epidemiology
Braz. j. microbiol ; 46(2): 493-500, Apr-Jun/2015. tab, graf
Article in English | LILACS | ID: lil-749740


This study evaluates the antimicrobial susceptibility and composition of subgingival biofilms in generalized aggressive periodontitis (GAP) patients treated using mechanical/antimicrobial therapies, including chlorhexidine (CHX), amoxicillin (AMX) and metronidazole (MET). GAP patients allocated to the placebo (C, n = 15) or test group (T, n = 16) received full-mouth disinfection with CHX, scaling and root planning, and systemic AMX (500 mg)/MET (250 mg) or placebos. Subgingival plaque samples were obtained at baseline, 3, 6, 9 and 12 months post-therapy from 3–4 periodontal pockets, and the samples were pooled and cultivated under anaerobic conditions. The minimum inhibitory concentrations (MICs) of AMX, MET and CHX were assessed using the microdilution method. Bacterial species present in the cultivated biofilm were identified by checkerboard DNA-DNA hybridization. At baseline, no differences in the MICs between groups were observed for the 3 antimicrobials. In the T group, significant increases in the MICs of CHX (p < 0.05) and AMX (p < 0.01) were detected during the first 3 months; however, the MIC of MET decreased at 12 months (p < 0.05). For several species, the MICs significantly changed over time in both groups, i.e., Streptococci MICs tended to increase, while for several periodontal pathogens, the MICs diminished. A transitory increase in the MIC of the subgingival biofilm to AMX and CHX was observed in GAP patients treated using enhanced mechanical therapy with topical CHX and systemic AMX/MET. Both protocols presented limited effects on the cultivable subgingival microbiota.

Adolescent , Adult , Female , Humans , Male , Young Adult , Aggressive Periodontitis/drug therapy , Amoxicillin/pharmacology , Anti-Infective Agents/pharmacology , Bacteria/drug effects , Biofilms/drug effects , Chlorhexidine/pharmacology , Metronidazole/pharmacology , Aggressive Periodontitis/microbiology , Amoxicillin/therapeutic use , Anti-Infective Agents/therapeutic use , Bacteria/classification , Bacteria/isolation & purification , Biofilms/growth & development , Chlorhexidine/therapeutic use , Longitudinal Studies , Microbial Sensitivity Tests , Metronidazole/therapeutic use , Placebos/administration & dosage , Treatment Outcome
Article in English | WPRIM | ID: wpr-184037


We investigated the effects of indacaterol on cough and phlegm in patients with stable chronic obstructive pulmonary disease (COPD). We performed a meta-analysis with five randomized controlled trials (RCTs) of indacaterol in stable COPD patients. The symptom severity was defined using the St. George's Respiratory Questionnaire (SGRQ). We analyzed patients treated with 150 microg (n = 945) and 300 microg (n = 832) out of 3,325 patients who completed the SGRQ from five RCTs. After a 12-week treatment of 150 microg indacaterol, cough improvement was reported in 36.5% (316/866) of patients treated with indacaterol vs. 32.2% (259/804) patients treated with placebo (Relative Ratio [RR], 1.13; 95% confidence interval [CI], 0.99-1.29). Phlegm improvement was reported in 31.0% (247/798) of patients treated with indacaterol vs. 30.6% (225/736) of patients treated with placebo (RR, 1.01; 95% CI, 0.87-1.18). Dyspnea improvement was reported in 39.5% (324/820) of patients treated with indacaterol vs. 31.5% (237/753) patients treated with placebo (RR, 1.33; 95% CI, 1.03-1.71; P = 0.001, I2 = 55.1%). Only dyspnea improvement was significant compared to placebo even at the 300 microg indacaterol dose. Compared to placebo, a 12-week treatment of the long-acting beta-agonist, indacaterol might not have a significant effect on cough or phlegm in stable COPD.

Administration, Inhalation , Anti-Bacterial Agents/therapeutic use , Bronchodilator Agents/therapeutic use , Cough/drug therapy , Dyspnea/drug therapy , Forced Expiratory Volume/drug effects , Humans , Indans/therapeutic use , Placebos/administration & dosage , Pulmonary Disease, Chronic Obstructive/drug therapy , Quinolones/therapeutic use , Sputum/drug effects , Surveys and Questionnaires , Treatment Outcome
Bogotá; IETS; dic. 2014. ilus.
Monography in Spanish | LILACS, BRISA | ID: biblio-847127


Introducción: Los trastornos del espectro autista (TEA) son un grupo de discapacidades del desarrollo, de características crónicas y que afectan de manera distinta a cada paciente. Los TEA se definen como una disfunción neurológica crónica con fuerte base genética que desde edades tempranas se manifiesta en una serie de síntomas basados en la tríada de Wing que incluye: la comunicación, flexibilidad e imaginación e interacción social. No existe tratamiento curativo para el TEA, las terapias están dirigidas al control de los síntomas. Debido a la heterogeneidad de los síntomas, las terapias deben adaptarse al caso individual del paciente. Las intervenciones para los pacientes con diagnóstico de TEA pueden incluir educación, terapia conductual, o manejo farmacológico. Objetivo: realizar una revisión, apreciación crítica y síntesis de la evidencia disponible sobre la efectividad y seguridad de la risperidona para el tratamiento de personas con diagnóstico de trastorno del espectro autista. Metodología: la evaluación fue realizada de acuerdo con un protocolo definido a priori por el grupo desarrollador. Se realizó una búsqueda sistemática en MEDLINE, EMBASE, Cochrane Database of Systematic Reviews, Database of Abstracts of Reviews of Effects, LILACS y Google, sin restricciones de idioma, fecha de publicación y tipo de estudio. Las búsquedas electrónicas fueron hechas en octubre de 2014 y se complementaron mediante búsqueda manual en bola de nieve y una consulta con expertos temáticos. La tamización de referencias se realizó por dos revisores de forma independiente y los desacuerdos fueron resueltos por consenso. La selección de estudios fue realizada mediante la revisión en texto completo de las referencias preseleccionadas, verificando los criterios de elegibilidad predefinidos. Las características y hallazgos de los estudios fueron extraídos a partir de las publicaciones originales. Resultados: Se identificó evidencia proveniente de 4 revisiones sistemáticas de moderada y alta calidad, que compraban risperidona con placebo, se encontró que risperidona fue superior a placebo en los desenlaces de impresión global de salud, irritabilidad, hiperactividad, estereotipias. Conclusiones: La risperidona comparada con placebo sugiere efectividad en relación a mejoría de síntomas como irritabilidad, hiperactividad y estereotipias, así como, de la impresión clínica global. No se puede establecer con la evidencia actual el perfil de seguridad de la risperidona, solo se evidenció que los pacientes que reciben risperidona tienen mayor riesgo de aumento de peso y de presentar síndrome de extrapiramidalismo.

Humans , Autism Spectrum Disorder/diagnosis , Autism Spectrum Disorder/drug therapy , Aripiprazole/administration & dosage , Benzodiazepines/administration & dosage , Biomedical Technology , Clonidine/administration & dosage , Clozapine/administration & dosage , Colombia , Haloperidol/administration & dosage , Placebos/administration & dosage , Quetiapine Fumarate/administration & dosage , Reproducibility of Results , Risperidone/administration & dosage , Treatment Outcome
Rev. cuba. invest. bioméd ; 32(3): 366-378, jul.-sep. 2013.
Article in Spanish | LILACS | ID: lil-705689


Introducción: quizás ningún otro término haya sido tan indebidamente utilizado y causado tanta confusión como ®placebo». Sus efectos han potenciado los tratamientos médicos en la historia sin el debido reconocimiento. Entendido como eventos atribuibles al significado que adquiere una intervención dentro de un contexto terapéutico dado, se redimensiona y aleja de las definiciones tautológicas dominantes. Objetivo: analizar los retos que esta postura teórica plantea, así como sus potencialidades para la investigación y la práctica clínica. Métodos: Se analizan las limitaciones de su uso en Ensayos Clínicos Aleatorizados, entre las que se destaca la paradoja de la eficacia. Se contrasta la evidencia sobre su efectividad, generada en distintos contextos. Se describen los placebos disponibles en la práctica clínica y situaciones de uso; así como las opiniones de médicos y pacientes. Se introduce su efecto desde la dimensión biopsicosocial, dentro de la Medicina del Estilo de Vida. Se esbozan razones que impiden a las medicinas alternativas ®ser mejor que un placebo». Por último, se identifica y ejemplifica su espacio dentro la práctica clínica. Conclusiones: el efecto del placebo debe ser comprendido como un efecto del contexto, estructurado sobre la base del significado individual asignado a la intervención dentro de una cultura e historia específicas, que resulta significativo sobre numerosas enfermedades, mediante la activación y modificación variables psicológicas y fisiológicas. Concebido como Ambiente Curativo Óptimo, adquiere el ®principio activo» necesario para actuar por sí mismo (cuando la alternativa es no hacer nada), o potenciando el efecto de los tratamientos convencionales

Introduction: no term has probably been as misused and has caused so much confusion as the term `placebo'. Its effects have strengthened medical treatments throughout history without receiving due recognition. Understood as events attributable to the significance acquired by an intervention in a given therapeutic context, it takes on a new dimension, detaching from the prevailing tautological definitions. Objective: analyze the challenges posed by this theoretical stand, as well as its potential for research and clinical practice. Method: an analysis is conducted of the limitations of its use in randomized clinical trials, among them the efficacyparadox. A contrast is made of evidence of its effectiveness generated in various contexts. A description is provided of placebos available in clinical practice and situations of use, as well as doctors' and patients' opinions. Its effect is presented from a biopsychosocial perspective, within the framework of Lifestyle Medicine. An outline is provided of the factors preventing alternative medicines from being ®better than a placebo». Finally, its place in clinical practice is identified and exemplified. Conclusions: the placebo effect should be understood as an effect from the context, structured on the basis of the individual significance assigned to the intervention by a specific culture and historical development, which is significant for a large number of diseases, through the activation and modification of psychological and physiological variables. Conceived of as an Optimal Healing Environment, it acquires the ®active principle» required to act by itself (when the alternative is doing nothing), or strengthen the effect of conventional treatments

Placebos/administration & dosage , Placebos/history , Placebos/therapeutic use , Placebo Effect
J. bras. pneumol ; 39(1): 56-62, jan.-fev. 2013. tab
Article in Portuguese | LILACS | ID: lil-668057


OBJETIVO: Estabelecer os limites superiores para mudanças em VEF1, capacidade vital lenta (CVL), CVF e capacidade inspiratória (CI) após o uso de placebo em pacientes com obstrução ao fluxo aéreo. MÉTODOS: Cento e dois adultos com obstrução ao fluxo aéreo (VEF1 = 62 ± 19% do previsto) foram incluídos neste estudo. Todos os participantes realizaram manobras de CVL e CVF antes e depois do uso de spray de placebo. As mudanças em VEF1, CVL, CVF e CI foram expressas em valores absolutos, porcentagem de variação em relação aos valores basais e porcentagem dos valores previstos, e foram calculados os IC95% e os percentis 95. A análise fatorial foi realizada a fim de determinar como essas alterações se agrupavam. RESULTADOS: Considerando os IC95% e percentis 95 e após o arredondamento dos valores, obtivemos os seguintes limites superiores para resposta significante: VEF1 = 0,20 L, CVF = 0,20 L, CVL = 0,25 L e CI = 0,30 L (em valores absolutos); VEF1 = 12%, CVF = 7%, CVL = 10% e CI = 15% (em porcentagem de variação em relação aos valores basais) e VEF1 = 7%, CVF = 6%, CVL = 7% e CI = 12% (em porcentagem dos valores previstos). CONCLUSÕES: Em pacientes com obstrução ao fluxo aéreo, a CI apresenta maior variabilidade do que a CVF e a CVL. Para a CI, valores maiores que 0,30 L e 15% de variação em relação ao valor basal devem ser considerados significantes. Para CVF, valores maiores que 0,20L e 7% de variação em relação ao valor basal são significantes. Alternativamente, alterações de mais de 0,20 L e 7% do previsto no VEF1 e na CVF devem ser consideradas significantes. Na análise fatorial, os parâmetros espirométricos se agruparam em três dimensões, expressando mudanças no fluxo, volume e hiperinsuflação dinâmica.

OBJECTIVE: To establish the upper limits for changes in FEV1, slow vital capacity (SVC), FVC, and inspiratory capacity (IC) after placebo administration in patients with airflow obstruction. METHODS: One hundred and two adults with airflow obstruction (FEV1 = 62 ± 19% of predicted) were included in the study. All of the participants performed SVC and FVC maneuvers before and after the administration of placebo spray. The changes in FEV1, SVC, FVC, and IC were expressed as absolute values, percentage of change from baseline values, and percentage of predicted values, 95% CIs and 95th percentiles being calculated. Factor analysis was performed in order to determine how those changes clustered. RESULTS: Considering the 95% CIs and 95th percentiles and after rounding the values, we found that the upper limits for a significant response were as follows: FEV1 = 0.20 L, FVC = 0.20 L, SVC = 0.25 L, and IC = 0.30 L (expressed as absolute values); FEV1 = 12%, FVC = 7%, SVC = 10%, and IC = 15% (expressed as percentage of change from baseline values); and FEV1 = 7%, FVC = 6%, SVC = 7%, and IC = 12% (expressed as percentage of predicted values). CONCLUSIONS: In patients with airflow obstruction, IC varies more widely than do FVC and SVC. For IC, values greater than 0.30 L and 15% of change from the baseline value can be considered significant. For FVC, values greater than 0.20 L and 7% of change from the baseline value are significant. Alternatively, changes exceeding 0.20 L and 7% of the predicted value can be considered significant for FEV1 and FVC. On factor analysis, spirometric parameters clustered into three dimensions, expressing changes in flows, volumes, and dynamic hyperinflation.

Adult , Aged , Aged, 80 and over , Female , Humans , Male , Middle Aged , Bronchodilator Agents/administration & dosage , Lung Diseases, Obstructive/drug therapy , Placebos/pharmacology , Vital Capacity/drug effects , Bronchodilator Agents/therapeutic use , Factor Analysis, Statistical , Forced Expiratory Volume/drug effects , Inspiratory Capacity/drug effects , Lung Diseases, Obstructive/physiopathology , Nasal Sprays , Placebos/administration & dosage , Spirometry , Statistics, Nonparametric
Rio de Janeiro; s.n; 2013. 116 p. tab.
Thesis in Portuguese | LILACS | ID: lil-712808


A dor neuropática é uma síndrome dolorosa crônica, que ocorre muito frequentemente em pacientes com hanseníase, de difícil tratamento. Objetivou-se avaliar o efeito terapêutico da S(+)-cetamina na dor neuropática e qualidade de vida em portadores de hanseníase atendidos em ambulatórios em São Luís - MA. Estudo experimental tipo ensaio clínico, prospectivo, aleatório, duplamente cego, controlado por placebo, com 34 pacientes distribuídos aleatoriamente em um dois grupos, cetamina e placebo por três meses e randomizados por numeração sequenciada. A dor foi avaliada por meio de escala analógica visual (EAV) nas seis visitas quinzenais (1, 2, 3, 4, 5 e 6), e pelo inventário DN4, na visita 1 e 6, com distribuição da S(+)-cetamina e o analgésico de resgate e avaliado os efeitos adversos em cada visita. Realizou-se a coleta de 15mL de sangue para exames de segurança na visita 1 e 6 e para quantificação de citocinas plasmáticas IL-1, IL-6 e TNFα, nas visitas 1, 2, 4 e 6. Foi também, avaliada a qualidade de vida por meio do questionário WHOQOL-Bref nas visitas 1 e 6. Os resultados demostraram predominância do sexo feminino, idade de 18 a 29 anos, pardos, solteiros, renda de 2 a 4 salários mínimos; e média de 7,78±2,21 anos de estudo. Na avaliação da dor pela EAV os dois grupos apresentaram uma redução dos escores médios de dor ao longo do tempo, e mostrou significância estatística p < 0,05. Entretanto não foi observada diferença estatística para os escores de dor entre os grupos e também, em relação ao uso do medicamento analgésico (codeína) de resgate. Houve redução significante nos escore de DN4 no grupo placebo em relação às avaliações iniciais e finais comparadas à cetamina, ainda os escores iniciais do DN4 foram significativamente menores no grupo placebo, nas avaliações de antes e depois do uso da S(+)-cetamina. Na avaliação da qualidade de vida nos domínios físico, psicológico, relações sociais e meio ambiente, não se observou diferença estatisticamente ...

Neuropathic pain is a chronic pain syndrome of difficult treatment, occurring frequently in patients with leprosy. The objective of this study was to evaluate the therapeutic effect of S(+)-ketamine on neuropathic pain and quality of life in patients with leprosy seen at an outpatient clinic in São Luís - Ma. Experimental study clinical trial, prospective, randomized, double-blind, placebo-controlled trial with 34 patients in a randomized two groups, ketamine and placebo for three months and randomized by sequential numbering. Pain was evaluated using a visual analogue scale (VAS) on six bimonthly visits (1, 2, 3, 4, 5 and 6), and using the DN4 questionnaire on visits 1 and 6, with distribution of S (+)-ketamine and rescue analgesic and adverse effects assessed at each visit. Blood (15ml) was drawn from patients for safety tests on visits 1 and 6, and on visits 1, 2, 4 and 6, to cytokines IL-1, IL-6 and TNFα. Quality of life was also evaluated using WHOQOL-Bref on visits 1 and 6. Results showed most subjects female, age 18 and 29 years of age, pardo ethnicity, single, income between 2 and 4 minimum salaries, and a mean 7.78±2.21 years of education. In the assessment of pain by VAS both groups showed a reduction in mean pain scores over time, and showed statistical significance p <0.05. However there was no statistical difference in pain scores between groups and also in relation to the use of analgesic medication (codeine). There was significant reduction in DN4 score in the placebo group compared to the initial and final evaluations compared to ketamine, although the initial DN4 scores were significantly lower in the placebo group, the assessments before and after the use of S (+)-ketamine. In evaluating the quality of life in the physical, psychological, social relationships and environment, there was no statistically significant difference between groups. The amounts of IL-1, IL-6 and TNF-α in serum of four collections of ketamine and placebo ...

Humans , Male , Female , Chronic Pain/diagnosis , Chronic Pain/drug therapy , Leprosy/therapy , Ketamine/administration & dosage , Ketamine/pharmacology , Administration, Oral , Double-Blind Method , Ketamine/therapeutic use , Pain Measurement/methods , Neuralgia/drug therapy , Placebos/administration & dosage , Quality of Life
Arq. bras. cardiol ; 99(2): 688-696, ago. 2012. graf
Article in Portuguese | LILACS | ID: lil-647719


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 and 8, TNF-α, complements C3 and C5, and highly sensitive C-reactive protein (HS-CRP) levels in the pre- and post-operative periods. METHODS: This study assessed 30 patients undergoing CABG-ECC with intermittent hypothermic cardioplegia, and having, at most, mild ventricular dysfunction. The patients were divided into two groups (placebo and Tmz), stratified by echocardiography, and received drug/placebo at the dose of 60 mg/day. Measurements were taken as follows: in the pre-operative period with no drug; on the day of surgery, corresponding to 12 to 15 days on drug/placebo; five minutes after aortic unclamping; 12 and 24 hours after surgery, for interleukins and complements; and 48 hours after surgery, for HS-CRP. RESULTS: No significant difference between the levels of interleukin 8, TNF-α, C3 and C5, and HS-CRP was observed. However, the interleukin 6 levels were significantly lower in the group treated as compared with those in the control group at all time points assessed. CONCLUSION: Trimetazidine proved to be effective only for reducing interleukin 6 in patients undergoing CABG.

Aged , Female , Humans , Male , Coronary Artery Bypass/methods , Trimetazidine/administration & dosage , Vasodilator Agents/administration & dosage , Biomarkers/blood , Cytokines/blood , Double-Blind Method , Inflammation Mediators/metabolism , Inflammation/metabolism , Postoperative Period , Prospective Studies , Placebos/administration & dosage , Time Factors , Treatment Outcome
Indian J Ophthalmol ; 2012 Jul-Aug; 60(4): 277-281
Article in English | IMSEAR | ID: sea-144853


Purpose: To compare the effects of preoperative use of topical anti-inflammatory prednisolone acetate, ketorolac tromethamine, nepafenac and placebo, on the maintenance of intraoperative mydriasis during cataract surgery. Design: Randomized clinical trial. Materials and Methods: This single-center, masked, randomized clinical study comprised 140 patients scheduled for cataract surgery. Patients (35 in each group) were randomized to receive placebo, prednisolone acetate, ketorolac tromethamine 0.4% or nepafenac. These eye drops were administered three times daily for the two days prior to surgery. The pupillary diameters were measured by the surgeon using a compass prior to the corneal section and at the end of surgery. The primary outcome was the number of patients with pupil ≥ 6mm at the end of the surgery; the secondary outcome was the number of patients with pupil ≥ 6mm at the beginning of the surgery. Results: All the patients achieved pupil ≥ 6mm at the beginning of the surgery. The number of patients in the prednisolone (29/35), nepafenac (31/35) and ketorolac (30/35) groups with pupil ≥ 6mm was greater than in the placebo group in the maintenance of intraoperative mydriasis (19/35 – P =0.003). There was no statistical difference among the prednisolone, nepafenac and ketorolac groups in the maintenance of intraoperative mydriasis (P =.791). There were no complications during surgery or related to the preoperative use of the eye drops. Conclusion: Preoperative use of ketorolac, prednisolone and nepafenac was effective in maintaining intraoperative mydriasis when compared with placebo.

Benzeneacetamides/administration & dosage , Benzeneacetamides/therapeutic use , Cataract Extraction/complications , Humans , Ketorolac Tromethamine/administration & dosage , Ketorolac Tromethamine/therapeutic use , Mydriasis/drug therapy , Mydriasis/etiology , Mydriasis/prevention & control , Patients , Phenylacetates/administration & dosage , Phenylacetates/therapeutic use , Placebos/administration & dosage , Placebos/therapeutic use , Prednisolone/administration & dosage , Prednisolone/analogs & derivatives , Prednisolone/therapeutic use , Preoperative Period , Randomized Controlled Trials as Topic
Article in English | WPRIM | ID: wpr-146176


To evaluate the efficacy of ronidazole for treatment of Tritrichomonas foetus infection, 6 Tritrichomonas-free kittens were experimentally infected with a Korean isolate of T. foetus. The experimental infection was confirmed by direct microscopy, culture, and single-tube nested PCR, and all cats demonstrated trophozoites of T. foetus by day 20 post-infection in the feces. From day 30 after the experimentally induced infection, 3 cats were treated with ronidazole (50 mg/kg twice a day for 14 days) and 3 other cats received placebo. Feces from each cat were tested for the presence of T. foetus by direct smear and culture of rectal swab samples using modified Diamond's medium once a week for 4 weeks. To confirm the culture results, the presence of T. foetus rRNA gene was determined by single-tube nested PCR assay. All 3 cats in the treatment group receiving ronidazole showed negative results for T. foetus infection during 2 weeks of treatment and 4 weeks follow-up by all detection methods used in this study. In contrast, rectal swab samples from cats in the control group were positive for T. foetus continuously throughout the study. The present study indicates that ronidazole is also effective to treat cats infected experimentally with a Korean isolate of T. foetus at a dose of 50 mg/kg twice a day for 14 days.

Animals , Antiprotozoal Agents/administration & dosage , Cat Diseases/drug therapy , Cats , Disease Models, Animal , Feces/parasitology , Male , Parasitology/methods , Placebos/administration & dosage , Polymerase Chain Reaction/methods , Protozoan Infections/drug therapy , Ronidazole/administration & dosage , Treatment Outcome , Tritrichomonas foetus/genetics
Femina ; 38(10)out. 2010.
Article in Portuguese | LILACS | ID: lil-574504


Com o objetivo de revelar o valor do efeito placebo no tratamento dos sintomas climatéricos, foi realizada uma busca, na literatura médica, por trabalhos que pudessem mostrar a dimensão desse efeito. O método usado foi tentar fazer o inverso do que é feito em trabalhos controlados por placebo, em que o placebo é o modelo de comparação, ou seja, procurou-se usar o efeito dos hormônios como modelo para avaliar o efeito do placebo. Também foi feita uma revisão da farmacologia concernente ao mecanismo de ação das drogas e dos placebos. Os resultados não são animadores, tendo em vista uma divergência grande nos valores obtidos, o que em parte é explicado pelas diferenças pessoais nas respostas e nos achados científicos; entretanto, o efeito placebo está presente em todo o tratamento com drogas ativas ou não.

In order to show the placebo effect on the treatment of the climacteric symptoms, a search in the literature on this subject was carried out intending to do the opposite that is usually done, that is, to take the active drug as a comparative model for the placebo, and to look for the differences between them in regard to the relief of menopausal transition symptoms. A review of the pharmacology regarding drugs mechanism and placebo effects was also conducted. The results are not encouraging because of the data differences, mainly in respect to the personal variability in the responses to active and inactive drugs that was observed in scientific presentations. However, the placebo effect is present in any kind of treatment, either with active or inactive drugs.

Humans , Female , Adult , Clinical Trials as Topic , Climacteric , Hormones/pharmacology , Placebo Effect , Placebos/administration & dosage , Pharmaceutical Preparations/administration & dosage , Hormone Replacement Therapy
Av. cardiol ; 29(1): 76-81, mar. 2009. graf, tab
Article in Spanish | LILACS | ID: lil-607919


Los estudios controlados con placebo son el método ideal para evaluar la eficacia del tratamiento médico. Debido al gran número de tratamientos de comprobada eficacia en ciertas aplicaciones, los estudios controlados con placebo son a menudo poco éticos. Los estudios de no-inferioridad y de equivalencia son apropiados para evaluar la eficacia de un tratamiento experimental versus un control activo cuando se plantea la hipótesis que el tratamiento experimental puede no ser superior a un tratamiento de comprobada eficacia, pero es clínica y estadísticamente no inferior. El diseño y el reporte de estos estudios deben de seguir las recomendaciones del grupo CONSORT. Para tal fin, es indispensable seleccionar un óptimo control activo. La eficacia del control activo debería ser documentada a través de buenos estudios históricos controlados con placebo; a partir de estos datos es indispensable determinar el margen de no-inferioridad. Los resultados del nuevo tratamiento deben ser comparados con el control activo por análisis múltiples, incluyendo el placebo putativo. El término de no-inferioridad es usado cuando se refiere a un estudio de una sola cola (diferencia en respuesta menor que delta); equivalencia cuando se refiere a estudio de dos colas (diferencia en respuesta entre -Δ y +Δ). Para documentar los planteamientos teóricos se recurre a datos de estudios publicados recientemente, relacionados con moléculas eficaces en el control de la presión arterial y en la reducción de los índices de mortalidad en enfermedades cardiovasculares.

Placebo-controlled trials are the ideal for evaluating medical treatment efficacy. Given the large number of proven effective treatment in several areas, placebo-controlled trials are often unethical. The non-inferiority and equivalence trials are appropriate for evaluation of the efficacy of an experimental treatment versus an active control when it is hypothesized that the experimental treatment may not be superior to a proven effective treatment, but is clinically and statistically not inferior in effectiveness. The design and reporting of these studies must follow the CONSORT statements. An active control must be selected. Good historical placebo-controlled trials documenting the efficacy of the active control must exist. From these historical trials, a margin of non-inferiority must be determined. The results of the new treatment must be compared with active control through multiple analysis, including a putative placebo comparison. The term non-inferority is used when referring to a 1-sided trial (difference in response lower than Δ); equivalence, when referring to 2-sided trials (difference in response between-Δ and +Δ). In order to give practical data, results of published trials related to active molecules effective in the control of blood pressure and in reducing mortality in cardiovascular diseases are used.

Humans , Clinical Trials, Phase I as Topic/statistics & numerical data , Clinical Trials, Phase I as Topic/methods , Placebos/administration & dosage , Placebos/analysis , Placebos/pharmacology , Therapeutic Equivalency , Venezuela
Av. cardiol ; 27(4): 184-195, dic. 2007. ilus, graf
Article in Spanish | LILACS | ID: lil-607899


Este documento es publicación de la Canadian Medical Association y revisado por el Dr. Andreas Wieldosz del Hospita de Ottawa. Su contenido tiene propósitos educativos e informativos, sobre las investigaciones más recientes, Está dirigido primordialmente a médicos en atención primaria y se le sugiere al lector consultar las respectivas publicaciones originales e información relacinada, antes de tomar las acciones mencionadas en este reporte.

Humans , Male , Angiotensins/antagonists & inhibitors , Coronary Disease/pathology , Heart Failure/pathology , Lipoproteins/therapeutic use , Placebos/administration & dosage , Pharmaceutical Preparations/metabolism , Blood Pressure , Placebos/pharmacology , Venezuela
Rev. chil. cienc. méd. biol ; 14(2): 67-71, 2004. tab
Article in Spanish | LILACS | ID: lil-418369


Placebo es una intervención diseñada para simular una terapia médica, que no tiene un efecto biológico sobre una determinada enfermedad. En ensayos clínicos, se utilizan con el objetivo de lograr el desconocimiento de los pacientes clínicos sobre las intervenciones asignadas, (ciego) junto con crear un grupo control, de modo de determinar la verdadera magnitud de la intervención en estudio. El efecto placebo, corresponde a la mejoría clínica como resultado de la percepción del paciente de estar recibiendo una intervención terapéutica efectiva. En el presente artículo se discute el concepto de placebo en ensayos clínicos, junto con una revisión del efecto placebo.

Humans , Placebo Effect , Placebos/therapeutic use , Controlled Clinical Trials as Topic , Pain/therapy , Single-Blind Method , Placebos/administration & dosage , Mental Disorders/therapy