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1.
Revista Digital de Postgrado ; 10(1): 262, abr. 2021. tab
Article in Spanish | LILACS, LIVECS | ID: biblio-1147578

ABSTRACT

El bloqueo del nervio peri prostático con lidocaína, proporciona un buen alivio del dolor en la realización de la biopsia prostática guiada por ultrasonido, pero el dolor post-procedimiento, puede llegar a ser significativo, la adición del supositorio de diclofenac, podría proporcionar alivio adicional. Se asignaron al azar pacientes en 2 grupos el grupo 1 bloqueo con lidocaína del plexo peri prostático + supositorio de diclofenac sódico y el grupo 2 bloqueo con lidocaína del plexo peri prostático + supositorio de placebo, realizando biopsia doble sextante, el dolor a varios intervalos después del procedimiento se registró en una escala visual análoga (EVA) de 0 a 10. Los 2 grupos fueron similares en cuanto a edad, volumen de próstata, antígeno prostático específico, diagnóstico histopatológico. Los pacientes que recibieron diclofenac tuvieron puntajes de dolor significativamente más bajos que los que recibieron placebo (2 frente a 3,35) p 0,02. La administración rectal de diclofenac antes de la realización de la biopsia de próstata es un procedimiento simple que alivia significativamente el dolor experimentado sin aumento en la morbilidad(AU)


The peri-prostatic nerve block with lidocaine, provides good pain relief in performing ultrasoundguided prostate biopsy, but the postprocedure pain can be significant, the addition of diclofenac suppository, could provide additional relief. Patients were randomly assigned in 2 groups to group 1 blockade with lidocaine of the prostatic peri plexus + suppository of diclofenac sodium and group 2 blockade with lidocaine of the prostatic peri plexus + placebo suppository, performing double sextant biopsy, pain at several intervals after the procedure was recorded on a visual analog scale (EVA) from 0 to 10. Thee 2 groups were similar in terms of age, prostate volume, prostate-specific antigen, histopathological diagnosis. Patients who received diclofenac had pain scores significantly lower than those who received placebo (2 vs. 3.35) p 0.02. Rectal administration of diclofenac before performing a prostate biopsy is a simple procedure that relieves significantly pain experienced without increased morbidity(AU)


Subject(s)
Humans , Male , Middle Aged , Aged , Aged, 80 and over , Prostate/pathology , Anti-Inflammatory Agents, Non-Steroidal/therapeutic use , Diclofenac/therapeutic use , Anesthetics, Local/therapeutic use , Lidocaine/therapeutic use , Nerve Block/methods , Placebos/therapeutic use , Prostate/diagnostic imaging , Administration, Rectal , Prospective Studies , Pain Management/methods , Image-Guided Biopsy , Anesthesia, Local
4.
Int. arch. otorhinolaryngol. (Impr.) ; 24(1): 62-67, Jan.-Mar. 2020. tab, graf
Article in English | LILACS | ID: biblio-1090549

ABSTRACT

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.


Subject(s)
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
5.
Rev. Hosp. Ital. B. Aires (2004) ; 40(1): 34-38, mar. 2020. tab
Article in Spanish | LILACS | ID: biblio-1102292

ABSTRACT

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)


Subject(s)
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
6.
REME rev. min. enferm ; 24: e1318, fev.2020. tab, graf
Article in Portuguese | LILACS, BDENF | ID: biblio-1125471

ABSTRACT

RESUMO Objetivo: avaliar a efetividade das essências florais de Bach na redução dos níveis de estresse docente. Método: ensaio clínico controlado, randomizado, duplo-cego, com delineamento prospectivo. Foram utilizados na coleta de dados um formulário validado à luz da teoria de Betty Neuman e três instrumentos, um na perspectiva perceptiva (PSS-14), o outro na prevalência dos sinais e sintomas (LSS) e um de avaliação dos aspectos bioeletrográfico (FAAB). A amostra foi constituída de 27 professores da rede básica de ensino com estresse médio e alto, distribuídos em dois grupos: intervenção (GI) e que recebeu floral e placebo (GP). Resultados: o GI mostrou-se efetivo na redução do estresse, sendo estatisticamente significante intragrupo com a diminuição das médias dos escores do PSS-14 (p=0,004, LSS - p = 0,000) e da bioeletrografia (p=0,011); bem como entre grupos com p-valor de 0,035 para LSS e FAAB com p= 0,001. Conclusão: as essências florais do sistema Bach mostraram-se efetivos no cuidado do estresse docente com a reestruturação da linha flexível de defesa, refletindo melhor relacionamento do professor com os estressores intra, inter e extrapessoais. Este estudo está registrado no ReBEC com o nº. UTN: U1111-1208-4987.


RESUMEN Objetivo: evaluar la efectividad de las esencias florales de Bach para reducir los niveles de estrés del personal docente. Método: ensayo clínico controlado, aleatorizado, doble ciego con diseño prospectivo. En la recogida de datos se utilizó un formulario validado a la luz de la teoría de Betty Neuman y tres instrumentos: uno en la perspectiva perceptiva (PSS-14), otro en la prevalencia de signos y síntomas (LSS) y otro para la evaluación de aspectos bioelectrográficos (FAAB) La muestra consistió en 27 profesores de educación básica con estrés medio y alto, divididos en dos grupos: intervención (GI), que recibió esencias florales, y placebo (GP). Resultados: el GI demostró ser efectivo para la reducción del estrés, siendo estadísticamente significativo dentro del grupo con disminución en las puntuaciones medias del PSS-14 (p = 0.004, LSS - p = 0.000) y bioelectrografía (p = 0.011); así como entre grupos con un valor de p de 0.035 para LSS y FAAB con p = 0.001. Conclusión: las Flores de Bach demostraron ser efectivas en el manejo del estrés de los docentes con la reestructuración de la línea flexible de defensa, reflejando una mejor relación entre el profesor y los estresores intra, inter y extrapersonales. El presente estudio está registrado en ReBEC bajo el nº. UTN: U1111-1208-4987.


ABSTRACT Objective: to evaluate the effectiveness of Bach flower essences in reducing teachers' stress levels. Method: a controlled, randomized, and double-blind clinical trial with a prospective design. In data collection, a form validated in the light of Betty Neuman's theory and another three instruments were used, one in the perceptive perspective (PSS-14), the second in the prevalence of the signs and symptoms (LSS), and the third for the evaluation of the bio-electrographic aspects (FAAB). The sample consisted of 27 teachers from the basic education network, with medium and high levels of stress and divided into two groups: intervention group (IG), the one that received Bach flower essences, and placebo group (PG). Results: the IG proved to be effective in reducing stress, being statistically significant intra-group with the decrease in the mean scores of PSS-14 (p=0.004), LSS (p=0.000), and bioelectrography (p=0.011); as well as between groups with a p-value of 0.035 for LSS, and FAAB with p=0.001. Conclusion: the Bach flower essences proved to be effective in the care of teachers' stress with the re-structuring of the flexible line of defense, reflecting in a better relationship between the teacher and intra-, inter-, and extra-personal stressors. This study is registered in the ReBEC under UTN Nº U1111-1208-4987.


Subject(s)
Humans , Placebos/therapeutic use , Psychiatric Nursing , Stress, Psychological , Therapeutics , Flower Essences , Faculty/psychology , Educational Personnel/statistics & numerical data
7.
Arq. gastroenterol ; 57(1): 87-90, Jan.-Feb. 2020.
Article in English | LILACS | ID: biblio-1098055

ABSTRACT

ABSTRACT Inflammatory bowel disease comprises two distinct conditions - Crohn's disease and ulcerative colitis - which can be treated with immunomodulators. A non-neglectable proportion of these patients will need biologic therapy, and many patients under biologic treatment will experience either primary or secondary failure. As a consequence, clinical trials evaluating new therapeutic alternatives are being developed. These trials share common features, such as being controlled with placebo. Placebo use in clinical trials is a matter of intense debate. Those who support placebo use highlight the methodologic advantages placebo-controlled trials have. Those against placebo use argue that it would be against ethical principles in clinical research to expose a patient to placebo when a valid therapeutic alternative exists. In this review, we summarize the existing arguments for and against the use of placebo in the context of inflammatory bowel disease research. We finally suggest that it is very likely that in the near future inflammatory bowel disease trials will no longer be controlled with a placebo arm, but instead they will be non-inferiority trials with an active comparator.


RESUMO A doença inflamatória intestinal compreende duas condições distintas: a doença de Crohn e a retocolite ulcerativa, que podem ser tratadas com imunomoduladores. Uma proporção não negligenciável desses pacientes necessitará de terapia biológica e, muitos destes em tratamento biológico, experimentarão falha primária ou secundária. Como consequência, ensaios clínicos avaliando novas alternativas terapêuticas estão sendo desenvolvidos. Estes ensaios partilham características comuns, tais como ser controlado com placebo. O uso de placebo em ensaios clínicos é uma questão de intenso debate. Aqueles que apoiam o uso do placebo destacam as vantagens metodológicas que os ensaios controlados com placebo têm. Aqueles contra o uso de placebo argumentam que seria contra os princípios éticos na investigação clínica expor um paciente ao placebo quando uma alternativa terapêutica válida existe. Nesta revisão, resumimos os argumentos existentes a favor e contra o uso de placebo no contexto da pesquisa de doença inflamatória intestinal. Finalmente, sugerimos que é muito provável que em um futuro próximo os ensaios de doença inflamatória intestinal não serão mais controlados com um braço placebo; em vez disso, serão feitos ensaios de não-inferioridade com um comparador ativo.


Subject(s)
Humans , Colitis, Ulcerative/drug therapy , Crohn Disease/drug therapy , Placebos , Clinical Trials as Topic
8.
Rev. latinoam. enferm. (Online) ; 28: e3369, 2020. tab, graf
Article in English | LILACS, BDENF | ID: biblio-1139217

ABSTRACT

Objective: to evaluate the effectiveness of ginge (Zingiber officinale) in reducing blood sugar and lipid levels in people with type 2 diabetes. Method: a randomized and double-blind clinical trial conducted with people with type 2 diabetes in primary care facilities. The study included individuals aged between 20 and 80 years old, using oral antidiabetic drugs and with HbA1c levels between 6.0% and 10%. The participants were paired 1:1, allocated in two distinct groups, and randomized in blocks, based on their HbA1c levels. In the experimental group, the participants used 1.2g of ginger and, in the control group, 1.2g of placebo, daily for 90 days. The primary outcome was a reduction in fasting blood sugar and HbA1c, and the secondary outcome was a reduction in lipids and HOMA-IR. 103 individuals completed the study, 47 in the experimental group and 56 in the control group. Results: the participants in the experimental group showed a greater reduction in the blood glucose and total cholesterol values compared to the control group. Conclusion: the use of ginger can help in the treatment of people with diabetes, and data support the inclusion of this herbal drug in the clinical practice of nurses. RBR-2rt2wy


Objetivo: avaliar a efetividade do gengibre (Zingiber officinale) na redução de níveis glicêmicos e lipídicos de pessoas com diabetes tipo 2. Método: ensaio clínico randomizado, duplo cego, conduzido com pessoas com diabetes tipo 2, em unidades de atenção primária à saúde. Foram incluídos no estudo indivíduos com idade entre 20 e 80 anos, em uso de antidiabéticos orais e com valores de HbA1c entre 6,0% e 10%. Os participantes foram pareados de 1:1, alocados em dois grupos distintos e randomizados em blocos, com base nos valores de HbA1c. No grupo experimental os participantes usaram 1,2g de gengibre, e no grupo controle 1,2g de placebo, diariamente, durante 90 dias. Os desfechos primários foram a redução da glicemia venosa de jejum e HbA1c, e os secundários a redução dos lipídicos e HOMA-IR. 103 pessoas concluíram o estudo, encontrando-se 47 no grupo experimental e 56 no grupo controle. Resultados: os participantes do grupo experimental apresentaram melhor redução dos valores de glicemia e colesterol total, em comparação com o grupo controle. Conclusão: o uso do gengibre pode auxiliar o tratamento das pessoas com a diabetes, e os dados dão suporte para a inserção desse fitoterápico na prática clínica dos enfermeiros. RBR-2rt2wy


Objetivo: evaluar la eficacia del jengibre (Zingiber officinale) en la reducción de los niveles glucémicos y de lípidos en personas con diabetes tipo 2. Método: ensayo clínico aleatorizado y doble ciego, realizado con personas con diabetes tipo 2 en unidades de atención primaria de salud. Se incluyeron en el estudio individuos con edades comprendidas entre 20 y 80 años, que utilizaban antidiabéticos orales y con valores de HbA1c entre 6,0% y 10%. Los participantes fueron comparados de forma equitativa (1:1), asignados a dos grupos distintos y aleatorizados en bloques, basados en sus valores de HbA1c. En el grupo experimental, los participantes utilizaron 1,2 g de jengibre, y en el grupo de control 1,2 g de placebo, diariamente durante 90 días. Los resultados primarios fueron la reducción de glucemia venosa en ayunas y de HbA1c, y los resultados secundarios fueron la reducción de lípidos y del índice HOMA-IR. El estudio contó con la participación de 103 personas, 47 en el grupo experimental y 56 en el grupo de control. Resultados: los participantes del grupo experimental presentaron una mayor reducción en los valores de glucosa y colesterol total, en comparación con el grupo de control Conclusión: el uso del jengibre puede ayudar en el tratamiento de personas con diabetes, y los datos respaldan la introducción de este fitoterapéutico en la práctica clínica de los enfermeros. RBR-2rt2wy


Subject(s)
Humans , Adult , Middle Aged , Aged , Aged, 80 and over , Placebos , Therapeutics , Effectiveness , Blood Glucose , Double-Blind Method , Control Groups , Ginger , Diabetes Mellitus, Type 2 , Glucose , Hypoglycemic Agents , Lipids
9.
J. appl. oral sci ; 28: e20190025, 2020. tab, graf
Article in English | LILACS, BBO | ID: biblio-1056588

ABSTRACT

Abstract Periodontal therapy usually requires local anesthesia. If effective, a non-invasive, liposomal anesthetic gel could increase the levels of acceptance of patients in relation to periodontal therapy. Objective: This study investigated the efficacy of liposomal anesthetic gel for pain control during periodontal therapy. Methodology: Forty volunteers with moderate to severe chronic periodontitis were recruited, of which at least three sextants required periodontal therapy. At least one of the selected teeth had one site with a probing depth of ≥4 mm. The volunteers received the following three gels: a placebo, lidocaine/prilocaine (Oraqix®), or a liposomal lidocaine/prilocaine, which were applied to different sextants. Pain frequency was registered during treatment and the volunteers received a digital counter to register any painful or uncomfortable experiences. At the end of each session, the volunteers indicated their pain intensity using rating scales (NRS-101 and VRS-4). The volunteers had their hemodynamic parameters measured by a non-invasive digital monitor. Results: Pain frequency/intensity did not show statistical difference between intervention groups. The tested gels did not interfere with the hemodynamic indices. Dental anxiety, suppuration and probing depth could influence pain during periodontal therapy. Conclusion: Our results suggest limited indications for the use of non-invasive anesthesia when used for scaling and root planing. Intra-pocket anesthetic gel could be a good option for anxious patients, or those who have a fear of needles.


Subject(s)
Humans , Male , Female , Adult , Middle Aged , Aged , Pain/prevention & control , Dental Scaling/adverse effects , Root Planing/adverse effects , Gels/administration & dosage , Anesthesia, Dental/methods , Anesthetics, Local/administration & dosage , Periodontal Pocket , Placebos , Prilocaine/administration & dosage , Pain Measurement/methods , Double-Blind Method , Chronic Periodontitis/complications , Chronic Periodontitis/therapy , Lidocaine, Prilocaine Drug Combination , Lidocaine/administration & dosage
11.
Braz. oral res. (Online) ; 34: e031, 2020. tab, graf
Article in English | LILACS | ID: biblio-1089386

ABSTRACT

Abstract: Probiotic therapy is a viable alternative to chlorhexidine, a widely used antiseptic in dentistry that produces significant adverse effects. This systematic review aimed to analyze the effects of probiotics on experimental gingivitis in humans. Two independent reviewers conducted a comprehensive literature search until March 2019. Randomized clinical trials and controlled clinical trials were selected. Outcome data were extracted and critically analyzed. A total of five articles were included in the qualitative synthesis. No meta-analysis could be conducted due to the heterogeneity of the selected studies. The use of probiotics showed a slight improvement in clinical parameters. Changes in gingival crevicular fluid volume were lower in the presence of the probiotic than in the placebo group. All the studies showed that the immediate, positive effects of probiotics during the period of discontinued mechanical oral hygiene were due to the modulation of the host response, not the anti-plaque effect. Investigators should conduct randomized clinical trials to elucidate the mechanisms of probiotic action and develop improved delivery systems.


Subject(s)
Humans , Male , Female , Probiotics/therapeutic use , Immunomodulation , Gingivitis/prevention & control , Placebos , Gingival Crevicular Fluid , Microbiota , Gingivitis/physiopathology
12.
Odovtos (En línea) ; 21(3): 10-15, Sep.-Dec. 2019. graf
Article in English | LILACS, BBO | ID: biblio-1091488

ABSTRACT

ABSTRACT Understanding the possible effects that a patient's psycho-neurobiological processes (such as the nocebo effect) may have on the every-day dental treatments, could assist the clinicians in preventing the onset of adverse events not related directly with the clinical procedure. At the same time, employing pathways to trigger plausible placebo effects could aid the clinician to enhance the outcome of ordinary clinical procedures and the patient's perspective. Identified factors, which could lead both to positive or negative effects, may be present in different ways. Prior personal experiences, second-hand information, alternative medicine, catastrophizing or patient motivation; all could have an indirect effect in the treatment outcome. A well-informed clinician should use such factors to individualize each patient treatment.


RESUMEN Comprender los posibles efectos que los procesos psico-neurobiológicos de un paciente (como el efecto nocebo) pueden tener en los tratamientos dentales diarios, podría ayudar a los clínicos a prevenir la aparición de eventos adversos que no estén relacionados directamente con el procedimiento clínico. Al mismo tiempo, el uso de vías para favorecer posibles efectos placebo podría ayudar al clínico a mejorar el resultado de sus procedimientos rutinarios y la perspectiva del paciente. Los factores identificados, ya sean positivos o negativos, pueden estar presentes de diferentes maneras. Experiencias personales anteriores, información de segunda mano, medicina alternativa, actitud catastrófica o motivación del paciente; todos podrían tener un efecto indirecto en el resultado del tratamiento. Un médico bien informado debe usar dichos factores para individualizar el tratamiento de cada paciente.


Subject(s)
Placebos/therapeutic use , Dental Anxiety/psychology , Nocebo Effect , Comprehensive Dental Care
13.
J. bras. nefrol ; 41(4): 492-500, Out.-Dec. 2019. tab, graf
Article in English | LILACS | ID: biblio-1056600

ABSTRACT

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.


Subject(s)
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
14.
Arch. Clin. Psychiatry (Impr.) ; 46(6): 165-168, Nov.-Dec. 2019. tab, graf
Article in English | LILACS | ID: biblio-1054913

ABSTRACT

Abstract Objective Schizophrenia is a complex and chronic psychiatric disorder. In recent years, studies have found glutamatergic system participation in its etiopathogenesis, especially through aberrant NMDA receptors functioning. Thus, drugs that modulate this activity, as amantadine and memantine, could theoretically be used in its treatment. To perform a systematic literature review about memantine and amantadine use as adjunct in schizophrenia treatment. Methods A systematic review of papers published in English indexed in the electronic database PubMed ® using the terms "memantine", "amantadine" and "schizophrenia" published until October 2016. Results We found 144 studies, 8 selected for analysis due to meet the objectives of this review. Some of these have shown benefits from such drug use, especially in symptoms measured by PANSS and its subdivisions, while others do not. Discussion: The data in the literature about these drugs use for schizophrenia treatment is still limited and have great heterogeneity. Thus, assay with greater robustness are needed to assess real benefits of these drugs as adjuvant therapy.


Subject(s)
Humans , Schizophrenia/drug therapy , Amantadine/therapeutic use , Memantine/therapeutic use , Receptors, N-Methyl-D-Aspartate/antagonists & inhibitors , Placebos , Psychiatric Status Rating Scales , Antipsychotic Agents/therapeutic use , Amantadine/adverse effects , Memantine/adverse effects , Double-Blind Method , Treatment Outcome , PubMed , Adjuvants, Anesthesia/therapeutic use
15.
Rev. Soc. Cardiol. Estado de Säo Paulo ; 29(3): 246-248, jul.-set. 2019. tab
Article in English, Portuguese | LILACS | ID: biblio-1022942

ABSTRACT

Já é bem conhecida a importância da terapêutica para os pacientes com diabetes mellitus (DM) no que diz respeito à redução dos eventos cardiovasculares e, por isso, existe interesse em comprovar a segurança cardiovascular das diferentes terapias anti-hiperglicêmicas disponíveis no mercado. O objetivo desta revisão consiste em discutir três grandes estudos publicados recentemente, LEADER, CANVAS e DECLARE ­ TIME 58, que avaliaram o efeito sobre morbidade e mortalidade cardiovascular das medicações em questão em comparação com placebo


The importance of therapy for patients with diabetes mellitus (DM) in reducing cardiovascular events is well-known and, therefore, there is interest in confirming the cardiovascular safety of the different antihyperglycemic therapies available on the market. The objective of this review is to discuss three large recently-published studies, LEADER, CANVAS and DECLARE ­ TIME 58, which evaluated the effect of the medications in question on morbidity and cardiovascular mortality as compared to a placebo


Subject(s)
Humans , Male , Female , Cardiovascular Diseases , Diabetes Mellitus/therapy , Evidence-Based Practice , Placebos , Risk Factors , Treatment Outcome , Peripheral Arterial Disease , Canagliflozin/therapeutic use , Metformin/therapeutic use
16.
Braz. J. Psychiatry (São Paulo, 1999, Impr.) ; 41(3): 245-253, May-June 2019. tab
Article in English | LILACS | ID: biblio-1011490

ABSTRACT

Objective: Bipolar depression is characterized by neurobiological features including perturbed oxidative biology, reduction in antioxidant levels, and a concomitant rise in oxidative stress markers. Bipolar depression manifests systemic inflammation, mitochondrial dysfunction, and changes in brain growth factors. The depressive phase of the disorder is the most common and responds the least to conventional treatments. Garcinia mangostana Linn, commonly known as mangosteen, is a tropical fruit. The pericarp's properties may reduce oxidative stress and inflammation and improve neurogenesis, making mangosteen pericarp a promising add-on therapy for bipolar depression. Methods: Participants will receive 24 weeks of either 1,000 mg mangosteen pericarp or placebo per day, in addition to their usual treatment. The primary outcome is change in severity of mood symptoms, measured using the Montgomery-Åsberg Depression Rating Scale (MADRS), over the treatment phase. Secondary outcomes include global psychopathology, quality of life, functioning, substance use, cognition, safety, biological data, and cost-effectiveness. A follow-up interview will be conducted 4 weeks post-treatment. Conclusion: The findings of this study may have implications for improving treatment outcomes for those with bipolar disorder and may contribute to our understanding of the pathophysiology of bipolar depression. Clinical trial registration: Australian and New Zealand Clinical Trial Registry, ACTRN12616000028404.


Subject(s)
Humans , Bipolar Disorder/drug therapy , Garcinia mangostana/chemistry , Depressive Disorder/drug therapy , Fruit/chemistry , Antioxidants/therapeutic use , Placebos/therapeutic use , Quality of Life , Australia
17.
Clinics ; 74: e800, 2019. tab, graf
Article in English | LILACS | ID: biblio-1001837

ABSTRACT

The very large economic and social burdens of fracture-related complications make rapid fracture healing a major public health goal. The role of parathyroid hormone (PTH) in treating osteoporosis is generally accepted, but the effect of PTH on fracture healing is controversial. This meta-analysis was designed to investigate the efficacy and safety of PTH in fracture healing. The EMBASE, PubMed, and Cochrane Library databases were systematically searched from the inception dates to April 26, 2018. The primary randomized clinical trials comparing PTH treatment for fracture healing with placebo or no treatment were identified. We did not gain additional information by contacting the authors of the primary studies. Two reviewers independently extracted the data and evaluated study quality. This meta-analysis was executed to determine the odds ratio, mean difference, standardized mean difference, and 95% confidence intervals with random-effects models. In total, 8 randomized trials including 524 patients met the inclusion criteria. There were significant differences in fracture healing time, pain relief and function improvement. There were no significant differences in the fracture healing rate or adverse events, including light-headedness, hypercalcemia, nausea, sweating and headache, except for slight bruising at the injection site. We determined that the effectiveness and safety of PTH in fracture healing is reasonably well established and credible.


Subject(s)
Humans , Parathyroid Hormone/therapeutic use , Fracture Healing/drug effects , Calcium-Regulating Hormones and Agents/therapeutic use , Placebos , Time Factors , Pain Measurement , Randomized Controlled Trials as Topic , Reproducibility of Results , Treatment Outcome , Publication Bias
18.
Rev. homeopatia (Säo Paulo) ; 82(3/4): 34-37, 2019.
Article in Portuguese | LILACS, HomeoIndex | ID: biblio-1049891

ABSTRACT

Os autores realizaram um estudo piloto, na Associação Paulista de Homeopatia, para averiguar os efeitos de placebo e medicação homeopática sobe os níveis pressóricos de pacientes portadores de hipertensão arterial sistêmica idiopática. Foram estudados 19 pacientes em uso concomitante ou não de drogas hipotensoras, sendo 14 do sexo feminino, com idade média de 53 anos, e 5 do sexo masculino, com idade média de 44 anos. Fez-se uso do medicamento homeopático único, escolhido por totalidade sintomática característica, nas dinamizações 6C, 12C, 30C, 200C, em doses repetidas, 2 vezes ao dia, por 4 semanas cada. Todos os pacientes receberam previamente placebo por um período de 4 semanas (fase "washout"). Constatou-se efeito significativo da terapêutica homeopática, porém, dentro de uma dinamização individualizada para cada paciente, além da individualização do medicamento. Os autores finalmente fazem considerações para estudos futuros. (AU)


The authors performed a pilot study at the São Paulo Medical Homeopathic Association to investigate the effects of placebo and homeopathic treatment on the blood pressure of patients with idiopathic hypertension. We analyzed 19 patients concomitantly using or not antihypertensive agents, 14 females, with average age 53 years old, and 5 males, with average age 44 years old. One single homeopathic drug was selected as per the total set of characteristic symptoms, and prescribed in dilutions 6C, 12C, 30C and 200C, in repeated doses, twice per day, over 4 weeks each. All the patients previously received placebo over 4 weeks (washout). We found significant effect of homeopathic treatment, however, only for the best individual dilution, in addition to the individualization of the prescribed drugs. The authors finally make some considerations relative to future studies. (au)


Subject(s)
Humans , Male , Female , Middle Aged , Hypertension/therapy , Antihypertensive Agents/therapeutic use , Placebos/therapeutic use , Homeopathic Therapeutics
19.
Rev. homeopatia (Säo Paulo) ; 82(3/4): 38-41, 2019.
Article in Portuguese | LILACS, HomeoIndex | ID: biblio-1049903

ABSTRACT

Os autores realizaram um estudo piloto de investigação clínica, no ambulatório da Associação Paulista de Homeopatia, para verificar os efeitos de placebo e de medicamentos homeopáticos, escolhidos por totalidade sintomática característica individual, com um grupo de pacientes portadores de hipertensão arterial. Foi enfocada a capacidade de atuação do placebo e de dinamizações sucessivas de medicamento único, 6C, 12C, 30C e 200C, em doses repetidas, 2 vezes ao dia, na referida totalidade sintomatológica, considerando-se seu desaparecimento ou melhoria. Placebo e homeopatia foram fornecidos em frascos idênticos, a cada 4 semanas, começando pelo placebo, até atingir a 200C. Consultas de controle a cada 2 semanas. Concluise pela significância do medicamento homeopático, que não produziu praticamente agravações ou patogenesias, em doses repetidas. A partir da experiência, os autores sugeres condições melhores para feitura de trabalhos semelhantes, para uma melhor avaliação estatística. (AU)


Nineteen patients with idiopathic high blood pressure were subjected to treatment with placebo and homeopathic medicines. Their effects on the characteristic symptoms used to select the individual medication of each patients were analyzed. Statistically significant effect was found for the homeopathic drugs. No aggravation of pathogenetic symptoms practically occurred with doses taken twice daily. Based on their experience, the authors suggest how to improve studies in this field. (AU)


Subject(s)
Humans , Male , Female , Adult , Middle Aged , Clinical Evolution , Homeopathic Remedy , Hypertension/drug therapy , Placebos/therapeutic use , Dynamization , Treatment Outcome
20.
Einstein (Säo Paulo) ; 17(2): eGS4414, 2019. tab, graf
Article in English | LILACS | ID: biblio-989781

ABSTRACT

ABSTRACT Objective To evaluate the cost-effectiveness of the addition of chemotherapy or abiraterone to androgen deprivation. Methods We developed an analytical model to determine the cost-effectiveness of the addition of docetaxel or abiraterone versus androgen deprivation therapy alone. Direct and indirect costs were included in the model. The effects were expressed in Quality-Adjusted Life Years adjusted for side effects. Results Compared to androgen deprivation therapy alone, the addition of chemotherapy and of abiraterone generated 0.492 and 0.999, respectively, in Quality-Adjusted Life Years. Abiraterone led to a Quality-Adjusted Life Years gain of 0.506 compared to docetaxel. The incremental costs per Quality-Adjusted Life Years were R$ 133.649,22 for docetaxel, R$ 330.828,70 for abiraterone and R$ 571.379,42 for abiraterone compared to docetaxel, respectively. Conclusion The addition of chemotherapy to androgen deprivation therapy is more cost-effective than the addition of abiraterone to androgen deprivation therapy. However, discounts on abiraterone cost might improve cost-effectiveness.


RESUMO Objetivo Avaliar a relação custo-efetividade da adição de quimioterapia ou abiraterona à terapia de privação hormonal. Métodos Um modelo analítico foi desenvolvido para determinar a relação custo-efetividade da adição de docetaxel ou abiraterona comparada à terapia de privação hormonal isolada. Custos diretos e indiretos foram incluídos no modelo. Os efeitos foram expressos em Anos de Vida Ajustados para Qualidade corrigidos pelos efeitos colaterais de cada terapia. Resultados A adição de quimioterapia e de abiraterona à terapia de privação hormonal aumentou os Anos de Vida Ajustados para Qualidade em 0,492 e 0,999, respectivamente, em comparação à terapia de privação hormonal isolada. A abiraterona promoveu ganho de Anos de Vida Ajustados para Qualidade de 0,506 em relação ao docetaxel. O custo incremental por Anos de Vida Ajustados para Qualidade foi R$ 133.649,22 para o docetaxel, R$ 330.828,70 para a abiraterona e R$ 571.379,42 para a abiraterona comparada ao docetaxel. Conclusão A adição de quimioterapia à terapia de privação hormonal é mais custo-efetiva que a adição de abiraterona à terapia de privação hormonal. Contudo, descontos no custo da abiraterona poderiam tornar esse tratamento mais custo-efetivo.


Subject(s)
Humans , Male , Prostatic Neoplasms/economics , Prostatic Neoplasms/drug therapy , Cost-Benefit Analysis/methods , Antineoplastic Agents, Hormonal/economics , Docetaxel/economics , Androgen Antagonists/economics , Androstenes/economics , Placebos/economics , Placebos/therapeutic use , Prostatic Neoplasms/mortality , Reference Values , Time Factors , Brazil , Antineoplastic Combined Chemotherapy Protocols/economics , Antineoplastic Combined Chemotherapy Protocols/therapeutic use , Reproducibility of Results , Treatment Outcome , Quality-Adjusted Life Years , Antineoplastic Agents, Hormonal/therapeutic use , Docetaxel/therapeutic use , Progression-Free Survival , Androgen Antagonists/therapeutic use , Androstenes/therapeutic use
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