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1.
Homeopatia Méx ; (n.esp): 112-122, feb. 2023. tab
Article in Spanish | LILACS, HomeoIndex | ID: biblio-1416736

ABSTRACT

Evaluar la eficacia y seguridad del estrógeno potenciado en comparación con el placebo en el tratamiento homeopático del dolor pélvico asociado a endometriosis (EAPP, por sus siglas en inglés). Diseño del estudio: El presente fue un estudio clínico aleatorizado, doble ciego, controlado con placebo, de 24 semanas, el cual incluyó a 50 mujeres de entre 18 y 45 años de edad con diagnóstico de endometriosis infiltrante profunda con base en ultrasonido transvaginal o imágenes de resonancia magnética después de preparación intestinal, así como puntaje ≥ 5 en una escala visual analógica (VAS: rango de 0 a 10 puntos) para el dolor pélvico asociado con la endometriosis. Se administró estrógeno potenciado (12cH, 18cH y 24cH) o placebo dos veces al día por vía oral. La medida principal de resultado fue el cambio en la severidad de los puntajes parcial y global de EAPP (VAS) de la línea basal a la semana 24, determinada como la diferencia en el puntaje medio de cinco modalidades de dolor pélvico crónico (dismenorrea, dispareunia profunda, dolor pélvico no cíclico, dolor intestinal cíclico y/o dolor urinario cíclico). Las medidas secundarias de resultado fueron la diferencia media de puntaje para la calidad de vida evaluada con el Cuestionario de Salud SF-36, los síntomas de depresión en el Inventario de la Depresión de Beck (BDI) y los síntomas de ansiedad en el Inventario de Ansiedad de Beck (BAI). Resultados: El puntaje global de EAPP (VAS: rango de 0 a 50 puntos) se redujo en 12.82 (p < 0.001) en el grupo tratado con estrógeno potenciado de la línea basal a la semana 24. El grupo que utilizó estrógeno potenciado también presentó una reducción en el puntaje parcial (VAS: rango de 0 a 10 puntos) en tres modalidades de EAPP: dismenorrea (3.28; p < 0.001), dolor pélvico no cíclico (2.71; p = 0.009) y dolor intestinal cíclico (3.40; p < 0.001). El grupo de placebo no mostró cambio significativo alguno en los puntajes global o parcial de EAPP. Además, el grupo de estrógeno potenciado mostró un mejoramiento significativo en tres de ocho ámbitos de SF-36 (dolor de cuerpo, vitalidad y salud mental) y síntomas de depresión (BDI). El grupo de placebo no mostró un mejoramiento significativo a este respecto. Estos resultados demuestran la superioridad del estrógeno potenciado sobre el placebo. Se asociaron pocos eventos adversos con el estrógeno potenciado. Conclusiones: El estrógeno potenciado (12cH, 18cH y 24cH) en dosis de 3 gotas dos veces al día durante 24 semanas fue significativamente más efectivo que el placebo para reducir el dolor pélvico asociado con la endometriosis. Registro del estudio clínico: ClinicalTrials.gov Identificador: https://clinicaltrials.gov/show/NCT02427386.


To evaluate the efficacy and safety of potentized estrogen compared to placebo in homeopathic treatment of endometriosis-associated pelvic pain (EAPP). Study design: The present was a 24-week, randomized, doubleblind, placebocontrolled trial that included 50 women aged 18-45 years old with diagnosis of deeply infiltrating endometriosis based on magnetic resonance imaging or transvaginal ultrasound after bowel preparation, and score ≥ 5 on a visual analogue scale (VAS: range 0 to 10 points) for endometriosis-associated pelvic pain. Potentized estrogen (12cH, 18cH and 24cH) or placebo was administered twice daily per oral route. The primary outcome measure was change in the severity of EAPP global and partial scores (VAS) from baseline to week 24, determined as the difference in the mean score of five modalities of chronic pelvic pain (dysmenorrhea, deep dyspareunia, non-cyclic pelvic pain, cyclic bowel pain and/or cyclic urinary pain). The secondary outcome measures were mean score difference for quality of life assessed with SF-36 Health Survey Questionnaire, depression symptoms on Beck Depression Inventory (BDI), and anxiety symptoms on Beck Anxiety Inventory (BAI). Results: The EAPP global score (VAS: range 0 to 50 points) decreased by 12.82 (p < 0.001) in the group treated with potentized estrogen from baseline to week 24. Group that used potentized estrogen also exhibited partial score (VAS: range 0 to 10 points) reduction in three EAPP modalities: dysmenorrhea (3.28; p < 0.001), non-cyclic pelvic pain (2.71; p = 0.009), and cyclic bowel pain (3.40; p < 0.001). Placebo group did not show any significant changes in EAPP global or partial scores. In addition, the potentized estrogen group showed significant improvement in three of eight SF-36 domains (bodily pain, vitality and mental health) and depression symptoms (BDI). Placebo group showed no significant improvement in this regard. These results demonstrate superiority of potentized estrogen over placebo. Few adverse events were associated with potentized estrogen. Conclusions: Potentized estrogen (12cH, 18cH and 24cH) at a dose of 3 drops twice daily for 24 weeks was significantly more effective than placebo for reducing endometriosis-associated pelvic pain.


Subject(s)
Humans , Female , Adolescent , Adult , Middle Aged , Homeopathic Therapeutics , Pelvic Pain/therapy , Endometriosis/complications , Estrogens/therapeutic use , Placebos , Double-Blind Method
2.
Braz. J. Pharm. Sci. (Online) ; 59: e21748, 2023. tab, graf
Article in English | LILACS | ID: biblio-1439490

ABSTRACT

Abstract The present study was carried out to evaluate the effect of Melatonin and Placebo in the patient with the Burning mouth (BMs). This double-blind, placebo-controlled randomized clinical trial study was carried out on 30 patients who were suffering from BMS. During this period patients were divided into 2 study and control groups. The study group used four 3 mg Melatonin daily and the control group received a placebo. Then the severity of the burning sensation was measured by the physician Sleep quality was measured using the VAS scale using the Petersburg questionnaire. Data in the application Enter SPSS 20 and then using T test or equivalent Nonparametric was analyzed, mean sleep score and mean severity of oral irritation before and after treatment in two the group was evaluated using T-test Independent. Level significance was considered 0.05. The results of the present study show that the use of melatonin and a placebo in patients with BMS reduces sensation and improves their sleep quality, although it may not reduce it completely. In this study severity of burning was 4.93±2.56 after treatment in the study group and 6.93±2.12 in the control group, which was statistically significant (P =0.036). No significant difference was observed between the two groups in the sleep quality score (P-value = 0.43). Using Melatonin can be a reliable way to treat pain for which there is no standard treatment to date. Although evidence suggests an association between sleep disorders and BMS, melatonin was not superior to a placebo in reducing BMS-induced burning in the present study. Identification of stressors and the ways to struggle with them, further studies with larger samples and higher oral doses, extended follow-up periods and control of psychological factors, and measurement of body mass index that may affect pharmacokinetics are recommended.


Subject(s)
Humans , Male , Female , Patients/classification , Burning Mouth Syndrome/pathology , Double-Blind Method , Randomized Controlled Trial , Melatonin/adverse effects , Placebos/adverse effects , Surveys and Questionnaires/classification
3.
Rev. Nutr. (Online) ; 36: e220103, 2023. tab, graf
Article in English | LILACS | ID: biblio-1521589

ABSTRACT

ABSTRACT Objective: This study aimed to evaluate the effect of baru nuts supplementation on body composition and metabolic profile in adults with type 2 diabetes. Methods: This is a randomized, placebo-controlled, crossover trial with 30 adults with type 2 diabetes. The assay had two periods of 12 weeks each, with a washout period of 12 weeks between treatments. The subjects were randomized and received the two treatments in alternate periods: supplementation of 30g baru nuts or placebo. Anthropometry, body composition, blood pressure, blood sampling, food intake, and physical activity data were analyzed. Results: Baru nut intake reduced waist circumference (p=0.032), compared to placebo group. In the intra-group analysis, baru nut intake reduced total cholesterol (p=0.012) and LDL-c (p=0.017). Conclusion: The daily intake of baru nuts improved abdominal adiposity. Therefore, these nuts should be included in the diet to improve the health status of adults with type 2 diabetes.


RESUMO: Objetivo: Avaliar o efeito da suplementação com amêndoa de baru sobre a composição corporal e perfil metabólico de adultos com diabetes Mellitus tipo 2. Métodos: Este é um estudo randomizado, placebo-controlado, crossover com 30 adultos com diabetes Mellitus tipo 2. O ensaio clínico foi dividido em dois períodos de 12 semanas cada, com um washout de 12 semanas entre os tratamentos. Os sujeitos foram randomizados e receberam dois tratamentos em períodos alternativos: suplementação com 30 g de amêndoa de baru ou placebo. Foram coletados dados referentes à antropometria, composição corporal, pressão arterial, amostras de sangue, ingestão de alimentos e práticas de atividade física. Resultados: A ingestão de amêndoa de baru reduziu a circunferência da cintura (p=0,032), em comparação com o grupo placebo. Na análise intragrupo, a ingestão de amêndoa de baru também reduziu o colesterol total (p=0,012) e LDL-c (p=0,017). Conclusão: A ingestão diária de amêndoa de baru melhorou a adiposidade abdominal, portanto, deve ser incluída na dieta para a melhora do estado de saúde de adultos com diabetes Mellitus tipo 2.


Subject(s)
Humans , Male , Female , Adult , Middle Aged , Young Adult , Body Composition , Dipteryx , Diabetes Mellitus, Type 2/metabolism , Placebos/therapeutic use , Cholesterol , Cross-Over Studies , Abdominal Circumference , Arterial Pressure
4.
Biomédica (Bogotá) ; 42(4): 562-573, oct.-dic. 2022. tab, graf
Article in Spanish | LILACS | ID: biblio-1420306

ABSTRACT

Los sistemas no lineales no son susceptibles de ser investigados con métodos reduccionistas. En este sentido, la teoría de la complejidad ofrece un enfoque alternativo para cuantificar la importancia de los factores contextuales en el paciente con dolor musculoesquelético. El resultado del uso positivo (placebo) o negativo (nocebo) de factores contextuales en el entorno terapéutico, podría ser responsable de gran parte de un componente inespecífico en la eficacia del tratamiento, afectando directamente la calidad de los resultados relacionados con la salud del paciente (por ejemplo, dolor, funcionalidad o satisfacción). En los últimos años, se ha incrementado la comprensión del valor de estos efectos. A pesar del creciente interés, el conocimiento y el reconocimiento de los efectos terapéuticos, continúan siendo limitados y heterogéneos entre los fisioterapeutas, lo cual reduce su valor traslacional en el campo de la fisioterapia. El propósito de este estudio es presentar el abordaje el paciente con dolor musculoesquelético desde la perspectiva la teoría de la complejidad.


Nonlinear systems are not susceptible to research with a reductionist approach. In this sense, the complexity theory provides an alternative approach to quantify the importance of contextual factors in patients with musculoskeletal pain. The use of positive (placebo) or negative (nocebo) contextual factors in the therapeutic setting could largely account for the non-specific component of treatment efficacy, directly affecting the quality of patients' health-related outcomes (e.g., pain, disability, or satisfaction). In recent years, there has been a better understanding of the effects of contextual factors. However, the knowledge and awareness of them is limited and heterogeneous among physical therapists, reducing their translational value in the field of physiotherapy. The purpose of this essay is to describe the management of patients with musculoskeletal pain from the complexity theory perspective.


Subject(s)
Systems Analysis , Musculoskeletal Pain , Placebos , Physical Therapy Modalities , Nocebo Effect
5.
Rev. Bras. Neurol. (Online) ; 58(2): 17-24, abr.-jun. 2022. graf
Article in English | LILACS | ID: biblio-1395441

ABSTRACT

INTRODUCTION: Tourette's Syndrome (TS) is a neurodevelopmental disorder characterized by motor and / or vocal tics for more than 12 months. TS affects about 0.8% of pediatric patients and is associated with great functional impairment and psychological distress. The present study aims to list and compare the effectiveness of therapies used in children and young people with TS. METHODS: PubMed / MEDLINE, Cochrane Library, ScienceDirect, SciELO and Lilacs were used from September 2020 to April 2021 to search for randomized clinical trials with pharmacological, behavioral, physical or alternative interventions for tics in children and young people with ST. RESULTS: 13 clinical trials were included, of which six pharmacological, six behavioral and one of other conformation. The global score on the Yale Global Tic Severity Scale showed evidence in favor of Habit Reversal Training (HRT) and Comprehensive Behavioral Intervention for Tics (CBIT). Evidence from two studies suggests that antipsychotic medications improve tic scores. Evidence from other interventions has shown no conclusive benefit. CONCLUSIONS: The present study identified benefits with the use of antipsychotics. The study also found that HRT and CBIT showed improvement in reducing the severity of tics, in addition to not having any adverse effects. These therapies showed significant clinical improvement, but there is no comparison between the use of these isolated approaches in relation to their use associated with medications. In view of the different forms of therapy, further studies are needed to identify the effectiveness and the profile of adverse effects of these interventions.


INTRODUÇÃO: A Síndrome de Tourette (ST) é um distúrbio do neurodesenvolvimento caracterizado por tiques motores e/ou vocais por mais de 12 meses. A ST afeta cerca de 0,8% dos pacientes pediátricos e associa-se a grande comprometimento funcional e sofrimento psíquico. O presente estudo tem como objetivo listar e comparar a eficácia das terapias utilizadas em crianças e jovens com ST. MÉTODOS: PubMed/MEDLINE, Cochrane Library, ScienceDirect, SciELO e Lilacs foram usados desde setembro de 2020 até abril de 2021 para a busca de ensaios clínicos randomizados com intervenções farmacológicas, comportamentais, físicas ou alternativas para tiques em crianças e jovens com ST. RESULTADOS: 13 ensaios clínicos foram incluídos, dos quais seis farmacológicos, seis comportamentais e um de outra conformação. A pontuação global na Yale Global Tic Severity Scale, apresentou evidências a favor do Treinamento de Reversão de Hábito (TRH) e Intervenção Comportamental Abrangente para Tiques (ICAT). As evidências de dois estudos sugerem que medicamentos antipsicóticos melhoram os escores de tiques. Evidências de outras intervenções não mostraram nenhum benefício conclusivo. CONCLUSÕES: O presente estudo identificou benefícios com o uso do antipsicóticos. O estudo também identificou que a TRH e a ICAT apresentaram melhora na redução da gravidade dos tiques, além de não apresentarem efeitos adversos. Essas terapias mostraram importante melhora clínica, mas não há comparação entre o uso dessas abordagens isoladas em relação ao seu uso associado com medicamentos. Diante das diferentes formas de terapia, mais estudos são necessários para identificar a eficácia e o perfil de efeitos adversos dessas intervenções.


Subject(s)
Humans , Child , Adolescent , Tic Disorders/therapy , Behavior Therapy , Tourette Syndrome/diagnosis , Tourette Syndrome/drug therapy , Placebos , Antipsychotic Agents/pharmacology , Treatment Outcome , Aripiprazole/pharmacology
6.
Psico USF ; 27(1): 157-167, jan.-mar. 2022. tab, graf
Article in Portuguese | LILACS, INDEXPSI | ID: biblio-1376039

ABSTRACT

Estudos mostram que o tabagismo é responsável por afetar algumas funções cognitivas. No entanto, a nicotina é apenas um dos componentes existentes no cigarro e existem evidências de que pode servir como agente neuroprotetivo e causar melhoras em algumas funções cognitivas. O objetivo desta pesquisa foi investigar como a nicotina interage com algumas funções cognitivas. Um ensaio clínico piloto com administração de gomas de nicotina contendo 2-mg ou 4-mg, ou gomas placebo contendo a mesma textura, sabor e aparência, foi realizado. Quarenta e dois participantes participaram da pesquisa e os resultados indicaram que a relação entre nicotina e o desempenho na tarefa Go/No-Go podem ser bidirecionais. Os resultados indicaram que participantes do grupo que utilizaram 4-mg de nicotina apresentaram menor desempenho, enquanto os participantes que fizeram uso de 2-mg de nicotina tiveram melhor desempenho do que os demais. Esta pesquisa tem aplicações biopsicossociais e podem ajudar na compreensão da relação entre tabagismo e nicotina, além de contribuir para estratégias que possam ajudar no abandono do cigarro ou na melhora de condições que afetem a cognição (AU).


Past findings in the literature indicated that smoking could affect given cognitive functions. However, nicotine is only one of the components in cigarettes and there is evidence that it may act as a neuroprotective agent and improve some cognitive functions. The purpose of this research was to investigate how nicotine interacts with certain cognitive functions. We conducted a pilot clinical trial using nicotine gum containing 2-mg or 4-mg, or placebo gum with the same texture, flavor, and appearance. Forty-two healthy nonsmokers were enrolled in this research. Our findings indicated that the relationship between nicotine and performance on the Go/No-Go task might be opposite. The results showed that participants in the 4-mg group performed worse, while participants who used 2-mg of nicotine performed better than the others. This research supports biopsychosocial applications and can help interpret the relationship between smoking and nicotine, and contribute to strategies that may support smoking cessation, or improve conditions that affect cognition (AU).


Estudios demuestran que el tabaquismo es responsable de afectar a algunas funciones cognitivas. Sin embargo, la nicotina es solo uno de los componentes de los cigarrillos, y existen evidencias de que la nicotina puede actuar como un agente neuroprotector y mejorar algunas funciones cognitivas. El objetivo de este estudio fue investigar cómo la nicotina interactúa con algunas funciones cognitivas. Se realizó un ensayo clínico piloto con la administración de chicles de nicotina de 2 mg o 4 mg, o chicles de placebo con la misma textura, sabor y apariencia. Cuarenta y dos participantes participaron en la investigación y los resultados indicaron que la relación entre la nicotina y el rendimiento en la tarea Go/No-go puede ser bidireccional. Los resultados indicaron que los participantes del grupo de 4 mg obtuvieron un menor rendimiento en las variables del Go/No-Go, mientras que los participantes que utilizaron 2 mg de nicotina obtuvieron un mejor rendimiento que los demás. Esta investigación respalda las aplicaciones biopsicosociales y puede ayudar a interpretar la relación entre el tabaquismo y la nicotina, además de contribuir a las estrategias que pueden ayudar a dejar de fumar o mejorar las condiciones que afectan la cognición (AU).


Subject(s)
Humans , Male , Female , Adult , Middle Aged , Executive Function , Nicotine Chewing Gum , Nicotine/administration & dosage , Placebos/administration & dosage , Tobacco Use Disorder/psychology , Chi-Square Distribution , Pilot Projects , Double-Blind Method , Analysis of Variance
8.
Article in Portuguese | LILACS, CONASS, ColecionaSUS, SES-GO | ID: biblio-1363165

ABSTRACT

Tecnologia: Riociguate e outros medicamentos de controle da hipertensão pulmonar. Indicação: Tratamento de Hipertensão Pulmonar Tomboembólica Crônica (HPTEC). Pergunta: Há superioridade em eficácia e segurança do riociguate, comparado a medicamentos disponíveis no SUS, no tratamento de HPTEC inoperável ou operada com hipertensão pulmonar residual? Métodos: Revisão rápida de evidências (overview) de revisões sistemáticas, com levantamento bibliográfico realizado na base de dados PUBMED, utilizando estratégia estruturada de busca. A qualidade metodológica das revisões sistemáticas foi avaliada com AMSTAR-2 (Assessing the Methodological Quality of Systematic Reviews). Resultados: Foram selecionadas 4 e incluídas 2 revisões sistemáticas. Conclusão: Comparado ao placebo, em tratamento de curto prazo de HPTEC, riociguate melhora a tolerância ao exercício, aumenta a chance de melhora da classificação funcional e tem similar risco de eventos adversos sérios, porém não reduz a mortalidade. Treprostinil tem efeitos similares a riociguate. Entretanto, ambrisentana, bosentana, macitentana ou sildenafila não diferem do placebo no tratamento de HPTEC


Technology: Riociguat and other drugs to control pulmonary hypertension. Indication: Treatment of chronic thromboembolic pulmonary hypertension (CTEPH). Question: Is riociguat more effective and safe than other drugs available in the Brazilian Public Health System for the treatment of inoperable or recurrent CTEPH? Methods: Rapid review of evidence (overview) from systematic reviews, with a bibliographic search in the PUBMED database, using a structured strategy. The methodological quality of systematic reviews was assessed with AMSTAR-2 (Methodological Quality Assessment of Systematic Reviews). Results: Four systematic reviews were selected and two included in this study. Conclusion: Compared to placebo, in the short-term treatment of CTEPH, riociguat improves exercise tolerance, increases the chance of improving functional classification, and has a similar risk of serious adverse events, but does not reduce mortality. Treprostinil has similar effects to riociguat. However, ambrisentan, bosentan, macitentan or sildenafil do not differ from placebo in the treatment of CTEPH


Subject(s)
Humans , Adult , Middle Aged , Aged , Aged, 80 and over , Young Adult , Pulmonary Embolism/drug therapy , Guanylate Cyclase/therapeutic use , Hypertension, Pulmonary/drug therapy , Placebos , Evidence-Informed Policy
9.
Article in Portuguese | LILACS, CONASS, ColecionaSUS, SES-GO | ID: biblio-1367185

ABSTRACT

Lisdexanfetamina e drogas disponíveis no SUS (metilfenidato, bupropiona, amitriptilina, clomipramina, nortriptilina). Indicação: Transtorno do Déficit de Atenção e Hiperatividade (TDAH) em crianças e adolescentes. Pergunta: Lisdexanfetamina é eficaz e segura para melhoria de sintomática, comparada ao placebo e medicações disponíveis no SUS, no tratamento de crianças e adolescentes com TDAH? Métodos: Revisão rápida de evidências (overview) de revisões sistemáticas, com levantamento bibliográfico realizado na base de dados PUBMED, utilizando estratégia estruturada de busca. A qualidade metodológica das revisões sistemáticas foi avaliada com AMSTAR-2 (A MeaSurement Tool to Assess systematic Reviews). Resultados: Foram selecionadas 3 revisões sistemáticas, que atenderam aos critérios de inclusão. Conclusão: Lisdexanfetamina e metilfenidato são mais eficazes que placebo, e similares entre si, para reduzir sintomas em escalas de avaliação. Lisdexanfetamina e metilfenidato têm risco similar ao placebo de abandono do tratamento devido a efeitos adversos. Bupropiona não é mais eficaz que placebo para alívio sintomático. Lisdexanfetamina tem efeitos adversos de redução do apetite e insônia/ dificuldades do sono. Não foram encontradas evidências na literatura sobre os efeitos terapêuticos de amitriptilina, clomipramina e nortriptilina no tratamento de crianças e adolescentes com TDAH


Lisdexamfetamine and drugs available in the Brazilian Public Health System (BPHS) (methylphenidate, bupropion, amitriptyline, clomipramine, nortriptyline, bupropion). Indication: Children and adolescents with Attention Deficit Hyperactivity Disorder (ADHD). Question: Lisdexamfetamine is effective and safe for symptomatic improvement, compared to placebo and drugs available in the BPHS, for treatment of children and adolescents with ADHD? Methods: Rapid response review of evidence (overview) of systematic reviews, with bibliographic search in the PUBMED database, using a structured strategy. The methodological quality of systematic reviews was assessed with AMSTAR-2 (A MeaSurement Tool to Assess systematic Reviews). Results: 3 systematic reviews met the inclusion criteria and were selected. Conclusion: Lisdexamfetamine and methylphenidate are more effective than placebo, and similar to each other, to reduce symptoms on rating scales. Lisdexamfetamine and methylphenidate are not different from placebo in the risk of treatment discontinuation due to adverse effects. Bupropion is no more effective than placebo for symptomatic relief. Lisdexamfetamine has adverse effects of decreased appetite and insomnia/sleep troubles. No evidence was found in the literature about therapeutic effects of amitriptyline, clomipramine and nortriptyline for treatment of children and adolescents with ADHD


Subject(s)
Humans , Child, Preschool , Child , Adolescent , Attention Deficit Disorder with Hyperactivity/drug therapy , Bupropion/therapeutic use , Lisdexamfetamine Dimesylate/therapeutic use , Methylphenidate/therapeutic use , Antidepressive Agents/therapeutic use , Placebos , Clomipramine/therapeutic use , Systematic Reviews as Topic , Amitriptyline/therapeutic use , Nortriptyline/therapeutic use
10.
Braz. J. Pharm. Sci. (Online) ; 58: e19516, 2022. tab, graf
Article in English | LILACS | ID: biblio-1383980

ABSTRACT

Abstract The present study aims to evaluate the effects of Ginkgo biloba (GKB) extract as "add- on" therapy with metformin on the lipid profile, inflammatory markers, leptin and the total antioxidant capacity (TAOC) of patients with type 2 diabetes mellitus (T2DM). It is a multi- center, randomized, placebo-controlled double-blinded clinical study. Sixty patients were allocated into two groups: control and treatment groups; they received orally either 120 mg starch/capsule or 120mg GKB/capsule, respectively as an adjuvant with metformin for 90 days. Blood samples were obtained at zero time and after 90 days. The blood was utilized for analysis of the lipid profile, inflammatory markers, leptin, and TAOC. The GKB extract produced a significant decrease in the levels of TG, LDL-c, and CRP, with a significant increase in HDL-c compared to baseline values. There were no significant changes reported in the placebo-treated group. It also produced a significant decrease in the concentrations of IL-6, TNF-α, and leptin compared to baseline values and placebo-treated groups with a significant increase in TAOC compared to baseline values. In conclusion, GKB extract, as an adjuvant with metformin, decreases inflammatory mediators, leptin level and improves the antioxidant status and lipid profile of T2DM patients improperly managed with metformin


Subject(s)
Humans , Male , Female , Adult , Middle Aged , Patients , Placebos/analysis , Randomized Controlled Trials as Topic , Double-Blind Method , Ginkgo biloba/adverse effects , Diabetes Mellitus, Type 2/complications , Metformin/pharmacology , Antioxidants/administration & dosage
11.
Rev. bras. oftalmol ; 81: e0035, 2022. tab
Article in English | LILACS | ID: biblio-1376791

ABSTRACT

ABSTRACT Objective: To evaluate the efficacy of mitomycin C in anatomical and functional success after modified transcanalicular diode laser dacryocystorhinostomy. Methods: A prospective, double-blinded, randomized placebo-controlled study compared the effect of topical mitomycin C on modified transcanalicular diode laser dacryocystorhinostomy. Group 1 had modified transcanalicular diode laser dacryocystorhinostomy with topical saline, while Group 2 had modified transcanalicular diode laser dacryocystorhinostomy with topical mitomycin C. Success was defined as anatomical patency and relief of symptoms at the end of 6 months. Results: Six months after surgery, Group 1 (30 patients) showed anatomical and functional success rates of 86.7% and 83.3%, respectively. Group 2 (32 patients) showed anatomical and functional success rates of 87.5% and 84.3%, respectively. There was no statistically significant difference between the groups 1 and 2 (p = 1.000). Conclusion: The use of mitomycin C did not improve the anatomical and functional success rates of modified transcanalicular diode laser dacryocystorhinostomy compared to placebo.


RESUMO Objetivo: Avaliar a eficácia da mitomicina C no sucesso anatômico e funcional após dacriocistorrinostomia transcanalicular com laser de diodo. Métodos: Estudo prospectivo, duplo-cego, randomizado e controlado por placebo. Comparou o efeito da mitomicina C tópica na dacriocistorrinostomia transcanalicular com laser de diodo. No Grupo 1, foi utilizada apenas solução salina tópica, enquanto no Grupo 2 foi utilizada mitomicina C tópica. O sucesso foi definido como permeabilidade da via lacrimal e alívio dos sintomas ao final de 6 meses. Resultados: Seis meses após a cirurgia, o Grupo 1 (30 pacientes) apresentou taxas de sucesso anatômico e funcional de 86,7% e 83,3%, respectivamente. O Grupo 2 (32 pacientes) apresentou taxas de sucesso anatômico e funcional de 87,5% e 84,3%, respectivamente. Não houve diferença estatística significante entre os Grupos 1 e 2 (p=1,000). Conclusão: O uso de mitomicina C não melhora as taxas de sucesso anatômico e funcional do dacriocistorrinostomia transcanalicular com laser de diodo em comparação ao placebo.


Subject(s)
Humans , Male , Female , Middle Aged , Dacryocystorhinostomy/methods , Mitomycin/administration & dosage , Mitomycin/therapeutic use , Mitomycin/pharmacology , Lasers, Semiconductor/therapeutic use , Nasolacrimal Duct/drug effects , Placebos , Random Allocation , Double-Blind Method , Prospective Studies , Follow-Up Studies , Treatment Outcome , Chemotherapy, Adjuvant , Dacryocystitis/surgery , Laser Therapy/methods , Lacrimal Duct Obstruction/therapy , Nasolacrimal Duct/surgery
12.
Rev. homeopatia (São Paulo) ; 83(1): 12-18, 2022.
Article in Portuguese | LILACS, HomeoIndex | ID: biblio-1359192

ABSTRACT

Na presente mesa-redonda apresentamos a evolução do nosso aprendizado como diretor de experimentação. Relata-se o trabalho comparado de três experimentações: A primeira com alunos do 3º ano do curso de especialização em homeopatia da Associação Médica Homeopática do Paraná e as duas seguintes com pacientes da clínica homeopática do diretor de experimentação que acederam participar das mesmas. Estes pacientes funcionais, agora experimentadores em estado de equilíbrio estável, foram convidados a participar da experimentação pelo fato de terem sido bem estudados e conhecido o medicamento homeopático que reequilibrou cada um deles. Experimentou-se, pois, um medicamento pelo "duplo-cego" em experimentadores cujo medicamento era conhecido, proceder até então inédito na experimentação homeopática. Enveredou-se por esse tipo de pesquisa pelo fato de nunca antes haver sido feita a comparação entre os sintomas comuns ao medicamento do experimentador e o medicamento experimentado. Inicialmente tal proceder objetivava, além de efetuar a comparação supracitada, confirmar ou refutar a afirmação de que os sintomas que surgem durante a experimentação são comuns ao medicamento experimentado e o experimentador e não apenas exclusivos do medicamento. Com o desenrolar das experimentações outros fatos importantes foram sendo constatados, como o retorno, anos depois, de sintomas desencadeados durante a experimentação, a confirmação do perfil dos medicamentos, sintomas não registrados na descrição das patogenesias etc. Todos esses dados são discutidos à medida que é apresentada a técnica do experimento (material e método), visto que o objetivo desta mesa-redonda é discutir os encaminhamentos para novas experimentações. Nestes encaminhamentos propõe-se: algumas adições à Ficha Clínica modelo LUIMO para experimentações, discussão sobre o perfil do experimentador ideal, formação de centrais de experimentação ancoradas em diretores de experimentação, independentemente da instituição a que pertençam, visto que as instituições permanecem mas os homens por que elas passam nem sempre têm as mesmas intenções.


Subject(s)
Placebos , Arsenicum Album , Experiment of Substances , Medical Records
14.
African Health Sciences ; 22(3): 108-116, 2022-10-26. Figures, Tables
Article in English | AIM | ID: biblio-1401066

ABSTRACT

Background: Drotaverine, a spasmolytic, has been found to have potential to achieve a reduction in the duration of labor and prevent prolonged labor. Objective: To compare the effects of intravenous drotaverine hydrochloride with placebo for shortening the duration of active phase of labor in primigravida's. Methods: A double-blind, placebo-controlled randomized trial of 246 primigravida's in active phase of labor at term was conducted. They were randomly (1:1 ratio) administered intravenous 2 ml (40mg) of drotaverine hydrochloride or 2 ml of Vitamin B complex as placebo. The primary outcome measure was the duration of active phase of labor. The secondary outcome measures were cervical dilatation rate, oxytocin augmentation rate, incidence of prolonged labor, labor pain scores, mode of delivery, maternal and neonatal outcomes. Results: The mean duration of active phase of labor (hour) was significantly lower in the drotaverine group compared to the control (drotaverine; 6.22 ± 2.41 vs placebo; 8.33 ± 3.56; p <0.001). Also, the cervical dilatation rate (cm/hr) was significantly faster in the drotaverine arm (drotaverine; 1.68 ± 1.02 versus placebo; 1.06 ± 0.53, p <0.001). There was a significantly higher probability of faster delivery among women who were given drotaverine (log-rank test, p < 0.001). The oxytocin augmentation rate, incidence of prolonged labor, labor pain scores, mode of delivery, maternal and neonatal outcomes were not significantly different among the groups. Conclusions: Drotaverine hydrochloride is effective in shortening the duration of active phase of labor without adverse maternal and neonatal outcomes. However, more evidence is needed to explore its role in active phase of labor among primigravid women. Trial registration number: PACTR201810902005232


Subject(s)
Parasympatholytics , Placebos , Clinical Laboratory Techniques , Duration of Therapy , Telomere Shortening , Nigeria
15.
Revista Digital de Postgrado ; 10(1): 262, abr. 2021. tab
Article in Spanish | LIVECS, LILACS | 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
17.
Rev. odontol. UNESP (Online) ; 50: e20210045, 2021. tab, ilus
Article in English | LILACS, BBO | ID: biblio-1352135

ABSTRACT

Introduction Gingivitis is a gingival inflammation which can often be treated with oral hygiene such as brushing, flossing, and an antiseptic mouthwash. Objective The aim of this randomized clinical trial was to clinically evaluate the effectiveness of 0.12% chlorhexidine (CHX) solution as an anti-inflammatory agent and for reducing the presence of plaque and inflammation in young adults. Material and method Thirty patients with gingivitis aged 18 to 30 years with a probing depth ≤ 3 mm and a minimum of 20 teeth in the whole mouth were selected and evaluated at baseline and 30 days after treatment. Periodontal clinical parameters were verified: plaque index (PI), gingival index (GI), Simplified Oral Hygiene Index (OHI-S), Simplified Debris Index (DI-S), and Simplified Calculus Index (CI-S) Patients were then randomly allocated into two groups: CHX Group, received chlorhexidine 0.12% labeled as solution 1, and Placebo Group, received saline solution labeled as solution 2. Both groups were included in a hygiene program and received mouthwash. Result Statistically significant differences between CHX and Placebo groups were observed for the variables PI, GI, DI-S, CI-S, and OHI-S (p<0.05 - Paired T Test) after 30 days. The CHX group presented improved GI compared to Placebo at 30 days. Chlorhexidine 0.12% was efficient in the control of periodontium inflammation. Conclusion It can be concluded that chlorhexidine as a mouthwash is efficient in improving periodontal indices in young adults, but it is still controversial whether age can influence GI and OHI-S.


Introdução A gengivite é uma inflamação gengival que geralmente pode ser tratada com higiene oral, como escovação, uso do fio dental e um anti-séptico bucal. Objetivo O objetivo deste ensaio clínico randomizado foi avaliar clinicamente a eficácia da solução de clorexidina 0,12% (CHX) como um agente antiinflamatório e na redução da presença de placa e inflamação em adultos jovens. Material e método Trinta pacientes com gengivite com idade entre 18 e 30 anos com profundidade de sondagem ≤ 3 mm com mínimo de 20 dentes em toda a boca foram selecionados e avaliados no início do estudo e 30 dias após o tratamento. Foram verificados os parâmetros clínicos periodontais: índice de placa (IP), índice gengival (GI), Índice de Higiene Oral Simplificado (IHO-S), Índice de Debris Simplificado (DI-S) e Índice de Cálculo Simplificado (IC-S). A seguir, os pacientes foram alocados aleatoriamente em dois grupos: Grupo CHX, recebeu clorexidina 0,12% previamente identificada como solução 1 e grupo placebo, recebeu solução salina identificada como solução 2. Ambos os grupos foram incluídos em programa de higiene e receberam enxaguatório bucal. Resultado Diferença estatisticamente significante entre os grupos CHX e Placebo foi observada para as variáveis ​​PI, GI, DI-S, CI-S e OHI-S (p <0,05 - Teste T Pareado) após 30 dias. O grupo CHX melhorou a resposta ao GI em comparação ao placebo em 30 dias. Clorexidina 0,12% foi eficiente no controle da inflamação do periodonto. Conclusão Pode-se concluir que a eficácia da clorexidina como enxaguatório bucal na melhora dos índices periodontais foi confirmada em adultos jovens, mas ainda é controverso que a idade pode influenciar o IG e IHO-S.


Subject(s)
Humans , Adolescent , Adult , Oral Hygiene , Periodontitis , Placebos , Chlorhexidine , Oral Hygiene Index , Periodontal Index , Gingivitis , Mouthwashes , Adolescent , Adult
18.
J. Phys. Educ. (Maringá) ; 32: e3274, 2021. tab, graf
Article in Portuguese | LILACS | ID: biblio-1360518

ABSTRACT

RESUMO O objetivo deste estudo foi verificar o efeito da massagem ou pseudomassagem no desempenho do salto vertical. Quinze participantes foram submetidos aleatoriamente a três condições experimentais: massagem, pseudomassagem e repouso. A condição de massagem exigiu três saltos verticais unipodais seguidos de dois minutos de massagem manual nos músculos flexores plantares e, antes de executar outros três saltos, foi aplicada a Escala de Recuperação de Qualidade Total (TQR). As duas condições a seguir foram estruturadas com os mesmos procedimentos, no entanto, os participantes foram submetidos à pseudomassagem (simples-cego) ou a dois minutos de descanso. Os resultados não mostraram diferenças estatísticas na altura do salto entre as análises pré e pós, nem entre as condições experimentais (massagem 18,7 ± 4,1 vs. 18,2 ± 4,1; pseudomassagem 19,1 ± 4,0 vs. 18,3 ± 3,8; descanso 19,0 ± 4,0 vs. 18,7 ± 3,9 cm). Também não houve diferenças estatísticas no TQR entre as condições experimentais (massagem 16,2 ± 4,3; pseudomassagem 16,4 ± 3,9; descanso 15,9 ± 2,6 ua). Tanto a massagem quanto a pseudomassagem não afetaram o desempenho no salto vertical e na TQR.


ABSTRACT The aim of this study was to verify the effect of massage or pseudo massage on vertical jump performance. Fifteen participants were randomly subjected to three experimental conditions: massage, pseudo massage and rest. The massage condition required three unipodal vertical jumps followed by two minutes of manual massage on plantar flexor muscles and, before performing another three jumps, the Total Quality Recover Scale (TQR) was applied. The two following conditions were structured with the same procedures, although participants were submitted either at pseudo massage (single-blinded) or two minutes of rest. Results showed no statistical differences on jump height between pre and post analysis nor between experimental conditions (massage 18.7 ± 4.1 vs 18.2 ± 4.1; pseudo massage 19.1 ± 4.0 vs 8.3 ± 3.8; rest 19.0 ± 4.0 vs 18.7 ± 3.9 cm). There were also no statistical differences in the TQR results between experimental conditions (massage 16.2 ± 4.3; pseudo massage 16.4 ± 3.9; rest 15.9 ± 2.6 ua). Both massage and pseudo massage did not affect performance on vertical jump and TQR.


Subject(s)
Humans , Male , Adult , Placebos , Massage/instrumentation , Relaxation , Men , Muscles
20.
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
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