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BACKGROUND: GLP-1 receptor agonists (GLP-1 RAs) have emerged as an effective therapeutic class for weight loss. However, the efficacy of these agents in reducing cardiovascular endpoints among patients living with obesity or overweight is unclear. METHODS: We conducted a systematic review and meta-analysis of randomized controlled trials (RCTs) comparing GLP-1 RAs versus placebo in patients with obesity or overweight. We searched PubMed, Cochrane, and Embase databases. A random-effects model was used to calculate risk ratios (RRs) and mean differences (MDs), with 95% confidence intervals (CIs). RESULTS: A total of 13 RCTs were included, with 30,512 patients. Compared with placebo, GLP-1 RAs reduced systolic blood pressure (MD - 4.76 mmHg; 95% CI - 6.03, - 3.50; p < 0.001; I2 = 100%) and diastolic blood pressure (MD - 1.41 mmHg; 95% CI - 2.64, - 0.17; p = 0.03; I2 = 100%). GLP-1 RA significantly reduced the occurrence of myocardial infarction (RR 0.72; 95% CI 0.61, 0.85; p < 0.001; I2 = 0%). There were no significant differences between groups in unstable angina (UA; RR 0.84; 95% CI 0.65, 1.07; p = 0.16; I2 = 0%), stroke (RR 0.91; 95% CI 0.74, 1.12; p = 0.38; I2 = 0%), atrial fibrillation (AF; RR 0.49; 95% CI 0.17, 1.43; p = 0.19; I2 = 22%), and deep vein thrombosis (RR 0.30; 95% CI 0.06, 1.40; p = 0.13; I2 = 0%). CONCLUSIONS: In patients living with obesity or overweight, GLP-1 RA reduced systolic and diastolic blood pressure and the occurrence of myocardial infarction, with a neutral effect on the occurrence of UA, stroke, AF, and deep vein thrombosis.
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Agonistas Receptor de Péptidos Similares al Glucagón , Obesidad , Ensayos Clínicos Controlados como Asunto , SobrepesoRESUMEN
INTRODUCTION: Molar incisor hypomineralisation (MIH) is a qualitative defect of enamel development that occurs in the mineralisation phase. MIH affects one or more permanent molars and, occasionally, permanent incisors. The aim of the proposed study is to evaluate the clinical effect of antimicrobial photodynamic therapy (aPDT) on permanent teeth with MIH through decontamination and sensitivity control. METHODS AND ANALYSIS: Patients from 8 to 12 years of age with permanent molars will be randomly allocated to three groups. Group 1: selective chemical-mechanical removal of carious dentinal tissue around the walls of the cavity with Papacárie Duo and a curette followed by the application of aPDT and deproteinisation with Papacárie Duo; group 2: selective removal of carious dentinal tissue around the walls of the cavity with a curette, followed by the application of aPDT and deproteinisation with a 5% sodium hypochlorite solution; group 3: selective removal of carious dentinal tissue using a curette. The selected teeth must have a carious lesion in the dentin and posteruptive enamel breakdown on one or more surfaces with an indication for clinical restorative treatment. The teeth will subsequently be restored using a mixed technique with resin-modified glass ionomer cement and bulk-fill composite resin. The data will be submitted to descriptive statistical analysis. Associations with age and sex will be tested using either the χ2 test or Fisher's exact test. Pearson's correlation coefficients will be calculated to determine the strength of correlations between variables. Comparisons of the microbiological results (colony-forming units) will be performed using analysis of variance and the Kruskal-Wallis test. Kaplan-Meier survival analysis will be performed to assess the performance of the restorations. ETHICS AND DISSEMINATION: This protocol has been approved by the Human Research Ethics Committee of Nove de Julho University (certificate number: 61027522.0.0000.5511/approval date: 23 August 2022). The findings will be published in a peer-reviewed journal. TRIAL REGISTRATION NUMBER: NCT05443035.
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Antiinfecciosos , Caries Dental , Hipomineralización Molar , Fotoquimioterapia , Humanos , Antiinfecciosos/uso terapéutico , Ensayos Clínicos Controlados como Asunto , Caries Dental/tratamiento farmacológico , Diente Molar/patología , Proyectos de Investigación , NiñoRESUMEN
BACKGROUND AND OBJECTIVES: Some patients have insufficient treatment response to conventional disease-modifying antirheumatic drugs (cDMARD); although biologics have proven to be an effective treatment for RA, the effects that bDMARDs have on integumentary, cardiac, and immune systems and the high costs associated with these treatments, make that mesenchymal stem cell-based therapies (MSCs) for RA are being considered potential treatment methods. This work analyses the performance in safety and efficacy terms of MSCs techniques. METHODS AND FINDING: A literature search was performed in PubMed, EMBASE, Cochrane Library, Web of Science, and Open Grey databases from inception to October 28, 2022. Three randomized controlled trials (RCTs) and one non-randomized controlled trial (non-RCTs), including 358 patients met our inclusion criteria and were included in qualitative synthesis; only RCTs were eligible for quantitative synthesis (meta-analysis). Meta-analysis of adverse events (AE) in RCTs showed no significant differences in the incidence of AE in the MSCs group compared to the control group (Risk ratio: 2.35; 95% CI, 0.58 to 9.58; I2 = 58.80%). The pooled Risk ratio for non-serious and serious adverse events showed no statistical difference between intervention and control groups concerning the incidence of non-serious and serious adverse events (Risk ratio: 2.35; 95% CI, 0.58 to 9.51; I2 = 58.62%) and (Risk ratio: 1.10; 95% CI, 0.15 to 7.97; I2 = 0.0%) respectively. The Health Assessment Questionnaire (HAQ) and Disease Activity Score (DAS28) decreased in agreement with the decreasing values of C-reactive protein (CRP) and Erythrocyte sedimentation rate (ESR). Additionally, a trend toward clinical efficacy was observed; however, this improvement was not shown in the studies after 12 months of follow-up without continuous treatment administration. CONCLUSION: This Systematic review and meta-analysis showed a favorable safety profile, without life-threatening events in subjects with RA, and a trend toward clinical efficacy that must be confirmed through high-quality RCTs, considerable sample size, and extended follow-up in subjects with RA.
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Antirreumáticos , Artritis Reumatoide , Humanos , Antirreumáticos/efectos adversos , Artritis Reumatoide/tratamiento farmacológico , Metotrexato/uso terapéutico , Resultado del Tratamiento , Ensayos Clínicos Controlados como AsuntoRESUMEN
Objetivos : Comparar la eficacia y toxicidad del antimoniato de meglumina (AM) y estibogluconato sódico (EGS) en el tratamiento de leishmaniasis cutánea (LC) en un hospital general. Material y métodos : Serie de casos comparativa de 193 pacientes con LC tratados en tres ensayos clínicos con AM (n=69) y EGS (n=124) durante 2001-2010. La administración de ambas drogas fue vía endovenosa lenta de 20 mg Sb5+/kg/día por 20 días consecutivos siguiendo las normativas de la OPS y OMS. La información clínica, toxicidad y eficacia fue obtenida de las historias clínicas almacenadas en el centro de investigación según la normativa local e internacional. Resultados : Las características demográficas fueron similares entre grupos, pero el tamaño y número de lesiones fueron mayores en el grupo AM. La eficacia del tratamiento con AM fue 76,0% versus 68,4% con EGS (p=0,340) y 55,1% versus 50,8% (p=0,570) en el análisis por protocolo y de intención de tratar, respectivamente. No se observaron efectos adversos inmediatos. Los síntomas más frecuentemente reportados fueron disgeusia (37,0%), mareos (32,0%), cefalea (36,0%), artralgias (31,0%) y linfangitis (21,0%). Los tres primeros síntomas, así como elevación de transaminasas, leucopenia, trombocitopenia y QTc prolongado fueron frecuentes en el grupo EGS, pero clínica y estadísticamente no significativos. El tratamiento fue suspendido definitivamente por toxicidad severa únicamente con EGS por emesis refractaria (2 participantes) y QTc prolongado con extrasístoles (1 participante). Conclusiones : La eficacia del tratamiento con AM y EGS fue comparable. La administración endovenosa de ambos no produjo efectos adversos inmediatos, aunque sí alteraciones clínicas y laboratoriales usuales.
SUMMARY Objectives : To compare the efficacy and safety of sodium stibogluconate (SS) and meglumine antimoniate (MA) in the treatment of cutaneous leishmaniasis (CL) in a general hospital. Methods: Case-series of 193 patients with CL treated in three clinical trials with MA (n=69) and SS (n=124) during 2001-2010. Both study drugs were administered intravenously at a slow speed at 20 mg Sb5+/kg/day for 20 consecutive days following WHO-PAHO recommendations. Clinical and safety data were gathered from clinical files. Results: Demographic characteristics were similar between the study groups, but the size and number of lesions were higher in the MA group. Efficacy was 76.0% in the MA vs. 68.4% in the SS group (p=0.340) and 55.1% vs. 50.8% (p=0.570) in the per protocol and intention to treat analysis. respectively. Side effects more frequently reported were dysgeusia (37.0%). dizziness (32.0%). headache (36.0%). arthralgia (31.0%) and lymphangitis (21.0%). These first three symptoms as well as elevation of transaminases, leukopenia, thrombocytopenia and prolonged QTc were numerically more frequent in the SS group but without reaching statistical significance. Treatment was stopped definitively for severe toxicity in the SS group due to refractory emesis (two patients) and prolonged QTc (one patient). Conclusions: The efficacy of MA and SS is comparable. The intravenous administration of these compounds did not produce immediate reactions, but it was associated with unusual clinical and laboratory abnormalities.
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Humanos , Leishmaniasis Cutánea , Gluconato de Sodio Antimonio , Ensayos Clínicos Controlados como Asunto , Antimoniato de MegluminaRESUMEN
El objetivo de este artículo es comparar las propiedades químicas y farmacológicas del telmisartán y el losartán, y su metabolito activo EXP3174, con el fin de entender por qué el telmisartán es efectivo en pacientes hospitalizados con Covid-19 mientras que el losartán no lo es. Se llevó a cabo una revisión bibliográfica exhaustiva de las propiedades químicas, farmacocinéticas y farmacodinámicas de ambos fármacos y se destacaron las diferencias más importantes que podrían estar relacionadas con su efectividad en pacientes con Covid-19. Se concluyó que las propiedades farmacológicas del telmisartán, como su mayor afinidad por el receptor AT1, su duración de acción prolongada y su capacidad para modular la inflamación podrían explicar su efectividad en pacientes con Covid-19. Por otro lado, las propiedades farmacológicas del losartán, como su menor afinidad por el receptor AT1 y su rápido metabolismo, pueden limitar su efectividad en pacientes con Covid-19. Estos resultados resaltan la importancia de comprender las propiedades químicas y farmacológicas de los medicamentos para identificar posibles candidatos terapéuticos efectivos en el tratamiento de Covid-19. (AU)
The objective of this article is to compare the chemical and pharmacological properties of telmisartan and losartan and their active metabolite EXP3174 to understand why telmisartan is effective in hospitalized patients with COVID-19 while losartan is not. A comprehensive literature review of the chemical, pharmacokinetic and pharmacodynamic properties of both drugs was done to highlight the most important differences that may be related to their efficacy in patients with COVID-19. It was concluded that the pharmacological properties of telmisartan, such as its higher affinity for the AT1 receptor, its long duration of action and its ability to modulate inflammation, could explain its efficacy in patients with COVID-19. On the other hand, the pharmacological properties of losartan, such as its lower affinity for the AT1 receptor and its rapid metabolism, may limit its efficacy in patients with COVID-19. These results highlight the importance of understanding the chemical and pharmacological properties of drugs to identify potential effective therapeutic candidates for the treatment of COVID-19. (AU)
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Losartán/farmacología , Telmisartán/farmacología , Tratamiento Farmacológico de COVID-19 , Ensayos Clínicos Controlados como Asunto , Losartán/química , Bloqueadores del Receptor Tipo 1 de Angiotensina II/farmacología , Telmisartán/química , HospitalizaciónRESUMEN
OBJECTIVES: This review aimed to assess the impact of mouthwashes on the composition of the human oral microbiome. METHOD: An electronic search algorithm was adapted to MEDLINE-PubMed, Scopus, Embase and ISI Web of Science, and reference lists of relevant sources were manually searched. Inclusion criteria were controlled clinical trials published in English whose population were adult individuals who rinse with antimicrobial mouthwashes and that analysed changes in the oral microbiome by metataxonomy, metagenomics or phylogenetic microarray. Identified studies were screened and assessed following the PRISMA guidelines, and results were compiled into qualitative synthesis of the evidence. RESULTS: Five controlled clinical studies were included. These studies found associations between the daily use of mouthwashes and changes in the oral microbiome, but the nature of the effect varied according to the mouthwash. Chlorhexidine (CHX) rinses lowered microbial diversity. While 7-day use of CHX led to increases in the abundance of Neisseria, Streptococcus and Granulicatella and a decrease in the abundance of Actinomyces, its prolonged use led to widespread reductions in several genera and species. Cetylpyridinium chloride-containing mouthwashes specifically lowered the abundance of gingivitis-associated genera. In contrast, N-acetyl cysteine-based mouthwashes did not promote changes in the oral microbiome. CONCLUSIONS: Despite substantial heterogeneity, we found evidence to support the hypothesis that CHX and CPC mouthwashes promote changes in oral microbial structure and/or reductions in community diversity that favour the resolution of dysbiosis. However, future large population-based studies of adequate duration are needed to fully understand the extent to which antimicrobial mouthwashes modulate the microbiome.
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Antiinfecciosos Locales , Antiinfecciosos , Placa Dental , Microbiota , Adulto , Humanos , Antiinfecciosos/farmacología , Antiinfecciosos/uso terapéutico , Antiinfecciosos Locales/uso terapéutico , Clorhexidina/uso terapéutico , Placa Dental/tratamiento farmacológico , Antisépticos Bucales/uso terapéutico , Filogenia , Ensayos Clínicos Controlados como AsuntoRESUMEN
ensaio clínico de pacientes únicos (ECPU/ensaio n-de-1) consiste na observação sistemática de condutas terapêuticas adotadas para otimizar o restabelecimento da saúde em um único paciente, com múltiplos cruzamentos ao longo do tratamento, podendo ter adicionalmente propósito de pesquisa clínica. Foi proposto há décadas e tem sido mais utilizado nas áreas de psicologia clínica, recebendo maior atenção em estudos médicos nos últimos anos. Embora seja considerado como o tipo de estudo com maior força para tomada de decisões terapêuticas, ainda são escassas as publicações sobre o seu emprego em medicina. Este artigo aborda as possibilidades dos ECPUs na avaliação dos resultados clínicos da homeopatia, explorando seus aspectos metodológicos, éticos e educacionais característicos em comparação aos ensaios clínicos randomizados tradicionais. Em pesquisa clínica, diferentemente dos ensaios convencionais, os ECPUs permitem a participação mais direta do paciente na escolha dos procedimentos e acompanhamento dos resultados, com possibilidade de alterações imediatas e sem que seja necessária sua exclusão do estudo, além de implicações de ordem econômica, política e ética. Podem ser utilizados no teste de medicamentos usados de modo off label, sem as restrições impostas à inclusão de pacientes vulneráveis nos estudos clínicos habituais, com excessiva artificialização no delineamento experimental. Poderiam ser ainda adotados nas diversas fases de teste clínico dos medicamentos, reduzindo a exposição de grande número de participantes aos riscos da pesquisa e baixa margem de extrapolação clínica dos resultados ao conjunto da população. Em homeopatia, podem ajudar a aprimorar o conhecimento dos medicamentos já em uso ou a melhor detectar os efeitos de novas substâncias testadas em ensaios patogenéticos homeopáticos. Em função do seu propósito principal de otimização do tratamento individual e do alinhamento com os princípios éticos da autonomia e beneficência associados à prática da medicina centrada-no-paciente ou de precisão - podem ser desenvolvidos em conjunto com o paciente e familiares, sem a obrigatoriedade de aprovação prévia por Comissões de Ética Médica ou Comitês de Ética em Pesquisa.
The single-patient clinical trial (n-of-1 trial) is primarily designed to systematically observe outcomes from different therapeutic options to optimize the restoration of health in a single patient, with multiple crossovers throughout the treatment. They may additionally have a clinical research purpose. They have been proposed for decades and were mostly used in clinical psychology, receiving greater attention in medical studies in recent years. Although it is considered the type of study with the greatest strength for therapeutic decision-making, there are still few publications with its application in medicine. This article discusses the possibilities of single-patient clinical trials in assessing homeopathy outcomes, exploring their characteristic methodological, educational and ethical aspects compared to traditional randomized clinical trials. In clinical research, unlike conventional trials, single-patient clinical trials allow for more direct patient participation in choosing procedures and monitoring results, with the possibility of immediate changes without the need for their exclusion from the study, in addition to economic, political and ethical implications. They can be used in testing off-label drugs without the restrictions imposed on the inclusion of vulnerable patients in usual clinical studies, with excessive artificiality in the experimental design. They could also be adopted in the various clinical trial phases of drugs, reducing the exposure of many participants to the risks of research and low margin of clinical extrapolation of the results to the entire population. In homeopathy, they can help refine the knowledge of medications already in use or better detect the effects of new substances tested in homeopathic pathogenetic trials. Due to their purpose of optimizing individual treatment and alignment with the principles of patient-centered or precision medicine they can be developed jointly with the patient and her family without the mandatory prior approval by Medical Ethics Committees or Research Ethics Committees.
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Humanos , Clínica Homeopática , Conductas Terapéuticas Homeopáticas/normas , Ensayos Clínicos Controlados como Asunto/ética , Ética Médica , Medicina de PrecisiónRESUMEN
Antecedentes A partir del 2014 en Colombia se incorporó la Tamización primaria con prueba de Virus del Papiloma Humano (VPH) desde los 30 hasta los 65 años, cuando la prueba es positiva se hace triage con citología para remisión a colposcopia. Actualmente se discute la conveniencia de iniciar la tamización con prueba de ADN de VPH a partir de los 25 años. De esta manera, el objetivo de esta evaluación de tecnologías sanitarias es analizar la evidencia disponible en torno a la seguridad, efectividad, costoefectividad, valores y preferencias, dilemas éticos y aspectos relacionados con la implementación para el contexto colombiano de la prueba ADN-VPH como estrategia de tamización cervical en mujeres menores de 30 años. Dominios a evaluar Eficacia clínica y seguridad 1. Tasa acumulada de neoplasia intraepitelial cervical (NIC) grado 2 o más avanzado luego de 2 rondas de tamización. 2. Tasas acumuladas de cáncer invasor de cérvix luego de 2 rondas de tamización. 3. Seguridad: remisión a colposcopia. Costo-efectividad Costo efectividad para Colombia. Otros dominios considerados Aspectos éticos asociados a la tamización cervical en mujeres menores de 30 años. Aspectos organizacionales y del individuo. Barreras y facilitadores relacionados con la implementación en el contexto colombiano de la tamización cervical en mujeres menores de 30 años. Métodos Evaluación de efectividad y seguridad clínicas Se realizó una búsqueda sistemática de la literatura en MEDLINE, Embase y CENTRAL de revisiones sistemáticas y ensayos clínicos. Se calificó el cuerpo de la evidencia con la aproximación GRADE. Posteriormente, se convocó a un grupo interdisciplinario a una mesa de trabajo en donde se presentó la evidencia recuperada, dando paso a la discusión y a la construcción de las conclusiones, siguiendo los lineamientos de un consenso formal acorde a la metodología RAND/UCLA. Estudio económico Se hizo una búsqueda sistemática de la literatura de estudios que hubieran evaluado el costo-efectividad para Colombia. Resultados De 7.659 referencias recuperadas se incluyeron 8 estudios. Resultados clínicos Se realizó un análisis integrativo de 5 ensayos clínicos aleatorizados que cumplieron con los citerios de inclusión. Cuando se compara frente a la citología, la tamización primaria con ADN-VPH en mujeres menores de 30 años, podría asociarse con una mayor frecuencia de detección de lesiones NIC2+ durante la primera ronda de cribado (RR: 1.57; IC: 1,20 a 2,04; certeza en la evidencia baja), con una menor incidencia de NIC2+ (RR:0,67; IC: 0,48 a 0,92; certeza en la evidencia baja) y se asocia con una menor frecuencia de carcinoma invasor al término del seguimiento (RR: 0,19; IC: 0,07 a 0,53; certeza en la evidencia alta). Resultados económicos Desde el punto de vista económico, la alternativa de ADN-VPH y triage con citología desde los 25 años quizás representa la alternativa más costo-efectiva para Colombia (razón costo-efectividad incremental $8.820.980 COP año 2013). Otras implicaciones Dos estudios sugieren que las barreras de implementación, atribuibles a circunstancias de intermediación, de orden público y de carácter geográfico, podrían ser solventadas por nuevas tecnologías o estrategias de cribado. Es importante considerar alternativas de forma de administración y de prestación de servicios para solventar algunas barreras de aceptabilidad y acceso. Todo programa de tamización cervical debe contemplar los principios éticos de no maleficencia, beneficencia, autonomía y equidad. Futuros estudios deben enfocarse en analizar nuevas tecnologías de cribado con énfasis en población menor de 30 años. Conclusiones El uso de la prueba ADN-VPH como estrategia de tamización en mujeres menores de 30 años es una intervención probablemente efectiva y costoefectiva para Colombia. Futuros estudios deben enfocarse en analizar nuevas tecnologías de cribado con énfasis en población menor de 30 años.
Background Primary screening with Human Papilloma Virus (HPV) testing was introduced in Colombia in 2014 for individuals between 30 and 65 years of age. When the result is positive, cytology triage is performed for colposcopy referral. The convenience of initiating HPV-DNA testing for screening at 25 years of age is currently a subject of discussion. Therefore, the objective of this health technology assessment (HTA) is to analyze the available evidence regarding safety, efficacy, cost-effectiveness, values and preferences, ethical dilemmas and considerations pertaining to the implementation of the HPV-DNA test as a cervical screening strategy in women under 30 years of age in the Colombian context. Domains to be assessed Clinical efficacy and safety 1. Cumulative rate of cervical intraepithelial neoplasia (CIN) grade 2 or high-er after 2 screening rounds. 2. Cumulative rates of invasive cancer of the uterine cervix after 2 screening rounds. 3. Safety: referral to colposcopy Cost-effectiveness Cost-effectiveness for Colombia. Other domains considered Ethical considerations associated with cervical screening in women under 30 years of age. Organizational and individual considerations. Barriers and facilitators pertaining to the implementation of cervical screening in women under 30 years of age in the Colombian context. Methods Clinical efficacy and safety assessment A systematic literature search of systematic reviews and clinical trials was conducted in MEDLINE, Embase and CENTRAL. The body of evidence was rated using the GRADE approach. An interdisciplinary team was then convened to create a working group to review the retrieved evidence. This led to the discussion and construction of the conclusions following the guidelines of a formal consensus in accordance with the RAND/UCLA methodology. Economic study Systematic literature research of studies that had assessed cost-effectiveness for Colombia. Results Out of the 7,659 references retrieved, 8 studies were included. Clinical outcomes An integrative analysis of 5 randomized clinical trials that met the inclusion critera was performed. Compared with cytology, primary HPV-DNA testing in women under 30 years of age could be associated with a lower frequency of CIN+2 lesions during the first screening round (RR: 1.57; CI: 1.20 to 2.04; low evidence certainty), and a lower incidence of CIN+2 (RR: 0.67; CI: 0.48 to 0.92; low evidence certainty). Moreover, it is associated with a lower frequency of invasive carcinoma at the end of follow-up (RR: 0.19; CI: 0.07 to 0.53; high evidence certainty). Economic results From the financial point of view, the use of HPVDNA testing plus cytology-based triage starting at 25 years of age is perhaps the most cost-effective option for Colombia (incremental cost-effectiveness ratio, COP 8,820,980 in 2013). Other implications Two studies suggest that barriers to implementation attributable to intermediation, public unrest and geographic considerations could be overcome with the use of new screening technologies or strategies. It is important to consider administration and service provision alternatives in order to overcome some acceptability and access barriers. Any cervical screening program must take into consideration ethical principles of nonmaleficence, beneficence, autonomy and equity. Future studies should focus on analyzing new screening techniques with emphasis on the population under 30 years of age. Conclusions The use of HPV-DNA testing as a screening strategy in women under 30 years of age is a potentially efficacious and cost-effective intervention for Colombia. Future studies should focus on analyzing new screening technologies, with emphasis on the population under 30 years of age.
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Humanos , Femenino , Adulto , Evaluación de la Tecnología Biomédica , Displasia del Cuello del Útero/diagnóstico , Tamizaje Masivo , Infecciones por Papillomavirus/diagnóstico , Pruebas de ADN del Papillomavirus Humano , Análisis Costo-Beneficio , Colombia , Colposcopía , Ensayos Clínicos Controlados como Asunto , Costos y Análisis de Costo , Detección Precoz del Cáncer , Revisiones Sistemáticas como AsuntoRESUMEN
INTRODUCTION: The complications from Parkinson's disease (PD) are directly related to decreased muscle function, balance deficits, and independence loss. Practicing aquatic exercises can minimize these symptoms and slow disease progress. OBJECTIVE: To develop a Multicomponent Aquatic Training (MAT) protocol for people with PD between stages 1 and 4 of the Hoehn and Yahr scale. METHODS: The protocol is for a single blind controlled clinical trial. The sample will comprise of people with PD between stages 1 and 4 in Hoehn and Yahr scale, divided into a control group and MAT group (who will participate in the MAT). Musculoskeletal function, functional mobility, and balance will be the primary outcomes of interest, assessed with an isokinetic dynamometer, the Five-Times-Sit-to-Stand test (FTSST), the Timed "Up and Go" test (TUG), the 6-m gait speed test, the Berg Balance Scale (BBS), and a force platform. Quality of life (QOL), activities of daily living (ADL), and motor aspects will be the secondary outcome measures, assessed with the Parkinson's Disease Questionnaire (PDQ-39) and Unified Parkinson's Disease Rating Scale (UPDRS), sections II and III. The MAT will be 12 weeks long, with two 50-min sessions per week. The outcome measures will be assessed before and after the interventions. DISCUSSION: This study is expected to establish parameters to prescribe and monitor a MAT program for people with PD in stages 1 to 4 in the Hoehn and Yahr scale, respecting individual progress and assisting the professionals in their procedure with these people.
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Enfermedad de Parkinson , Calidad de Vida , Actividades Cotidianas , Ensayos Clínicos Controlados como Asunto , Terapia por Ejercicio , Humanos , Enfermedad de Parkinson/complicaciones , Equilibrio Postural/fisiología , Método Simple CiegoRESUMEN
Objetivo: descrever a produção nacional da Enfermagem brasileira de estudos experimentais publicados nos últimos cinco anos. Método: revisão integrativa realizada nas bases de dados MEDLINE, Embase, CINAHL e Scopus e na Biblioteca Virtual em Saúde. Para a estratégia de busca, utilizaram-se os descritores: "Ensaio Clínico Controlado", "Ensaio Clínico", "Ensaio Clínico Controlado Aleatório" e "Pesquisa em Enfermagem". Incluíram-se: artigos originais publicados entre os anos de 2015 e 2020, em português, inglês e/ou espanhol, tendo enfermeiros como primeiro autor e com pontuação cinco no escore de Jadad. Resultados: foram analisados 16 artigos, com escore cinco na escala de Jadad, que contemplam três premissas: randomização, cegamento e descrição de perdas adequadamente. Identificaram-se quatro grandes áreas de conhecimento: práticas integrativas, saúde do adulto-idoso, saúde maternoinfantil e estomaterapia. Na temática de práticas integrativas, os estudos demonstraram a eficácia dessas práticas, enquanto, na área de saúde adulto-idoso e maternoinfantil, prevaleceram estudos de intervenções educativas; estudos de estomaterapia abordaram terapias tópicas que auxiliam no processo de cicatrização tecidual/prevenção de lesões de pele. Conclusão: identificou-se que o principal enfoque dos estudos com o método experimental por enfermeiros brasileiros pertencia a quatro grandes áreas de conhecimento da saúde e abordaram questões educativas e intervenções clínicas da prática da Enfermagem.(AU)
Objective: to describe the national production of Brazilian Nursing experimental studies published in the last five years. Method: integrative review conducted in the MEDLINE, Embase, CINAHL and Scopus databases and in the Virtual Health Library. For the search strategy, the following descriptors were used: "Controlled Clinical Trial", "Clinical Trial", "Randomized Controlled Clinical Trial" and "Nursing Research". Included were: original articles published between the years 2015 and 2020, in Portuguese, English and/or Spanish, with nurses as first author and with a score of five in the Jadad. Results: a total of 16 articles were analyzed, with a score of five on the Jadad scale, which contemplate three premises: randomization, blinding, and adequate description of losses. Four major areas of knowledge were identified: integrative practices, adult and elderly health, maternal and child health, and stoma therapy. In the theme of integrative practices, the studies demonstrated the effectiveness of these practices, while in the area of adult-elderly and maternal-infant health, studies of educational interventions prevailed; stoma therapy studies addressed topical therapies that assist in the process of tissue healing/prevention of skin lesions. Conclusion: it was identified that the main focus of studies with the experimental method by Brazilian nurses belonged to four major areas of health knowledge and addressed educational issues and clinical interventions in Nursing practice.(AU)
Objetivo: describir la producción nacional de Enfermería brasileña de estudios experimentales publicados en los últimos cinco años. Método: revisión integradora realizada en las bases de datos MEDLINE, Embase, CINAHL y Scopus y en la Biblioteca Virtual en Salud. Para la estrategia de búsqueda se utilizaron los siguientes descriptores: "Ensayo Clínico Controlado", "Ensayo Clínico", "Ensayo Clínico Controlado Aleatorio" e "Investigación en Enfermería". Se incluyeron: artículos originales publicados entre 2015 y 2020, en portugués, inglés y/o español, con enfermeros como primer autor y con puntuación de cinco en la escala de Jadad. Resultados: se analizaron 16 artículos, con puntaje de cinco en la escala de Jadad, que incluyen tres premisas: aleatorización, cegamiento y descripción de las pérdidas adecuadamente. Se identificaron cuatro grandes áreas de conocimiento: prácticas integradoras, salud adulto-anciano, salud materno-infantil y estomaterapia. En el área de prácticas integradoras, los estudios demostraron la efectividad de estas prácticas, mientras que, en el área de salud adultoanciano y materno-infantil, prevalecieron los estudios de intervenciones educativas; Los estudios de estomaterapia han abordado terapias tópicas que ayudan en el proceso de curación de tejidos/prevención de lesiones en la piel. Conclusión: se identificó que el foco principal de los estudios con el método experimental de los enfermeros brasileños pertenecía a cuatro grandes áreas del conocimiento en salud y abordaron cuestiones educativas e intervenciones clínicas en la práctica de Enfermería.(AU)
Asunto(s)
Humanos , Masculino , Femenino , Brasil , Ensayos Clínicos como Asunto , Enfermería , Ensayos Clínicos Controlados como Asunto , Comunicación y Divulgación Científica , Investigación en Enfermería , MEDLINERESUMEN
OBJETIVO: avaliar a compreensão das informações do Termo de Consentimento Livre e Esclarecido pelos participantes de uma pesquisa clínica de vacina contra o Zika vírus. MÉTODO: estudo transversal com amostra por conveniência e participação de 101 voluntários de uma pesquisa clínica em Belo Horizonte, Minas Gerais. Utilizou-se um questionário estruturado. A análise dos dados foi realizada no programa R, segundo a estatística descritiva e inferencial. RESULTADOS: a média de acertos dos participantes sobre as informações do documento de consentimento foi de 66,9%. A maioria dos participantes assinou o documento sem o conhecimento suficiente das informações da pesquisa. O Índice de compreensão foi maior entre os participantes que tinham se voluntariado em pesquisas prévias (p=0,039). CONCLUSÃO: verificaram-se limitações importantes na compreensão dos participantes sobre informações do termo de consentimento, o que comprometeu a decisão autônoma. São necessárias adaptações e melhorias nos processos de consentimento informado em prol da sua validade.
OBJECTIVE: to assess the understanding of the information contained in the Informed Consent Form by the participants of a clinical trial of a vaccine against the Zika virus. METHOD: cross-sectional study using intentional sampling, including a total of 101 volunteers in clinical research in Belo Horizonte, Minas Gerais. A structured questionnaire was used. Data analysis was performed using R software, according to descriptive and inferential statistics. RESULTS: the mean of correct answers of the participants regarding the information in the consent form was 66.9%. Most participants signed the document without sufficient knowledge of the research information. The comprehension index was higher among participants who had volunteered in previous research (p=0.039). CONCLUSION: there were important limitations in the participants' understanding of information in the consent form, which compromised the autonomous decision. Adaptations and improvements are necessary in the processes of informed consent for its validity.
OBJETIVO: evaluar la comprensión de las informaciones contenidas en el Término de Consentimiento Libre e Informado por los participantes de un ensayo clínico de una vacuna contra el virus del Zika. MÉTODO: estudio transversal con muestra de conveniencia y participación de 101 voluntarios en una investigación clínica en Belo Horizonte, Minas Gerais. Se utilizó un cuestionario estructurado. El análisis de datos se realizó mediante el programa R, según estadística descriptiva e inferencial. RESULTADOS: el promedio de aciertos de los participantes con respecto a las informaciones del documento de consentimiento fue de 66,9%. La mayoría de los participantes firmó el documento sin conocimiento suficiente de las informaciones de la investigación. El índice de comprensión fue mayor entre los participantes que se habían ofrecido como voluntarios en investigaciones anteriores (p=0,039). CONCLUSIÓN: hubo limitaciones importantes en la comprensión de las informaciones del formulario de consentimiento por parte de los participantes, lo que comprometió la decisión autónoma. Son necesarias adecuaciones y mejoras en los procesos de consentimiento informado para su validez.
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Humanos , Masculino , Femenino , Adulto , Adulto Joven , Vacunas Virales , Comprensión , Virus Zika , Consentimiento Informado , Estudios Transversales , Ensayos Clínicos Controlados como Asunto , Ética en InvestigaciónRESUMEN
The aim of this study was to carry out a systematic review of controlled clinical trials in order to identify both specific populations and social issues which may benefit from the effective use of psychodrama psychotherapy. A search was conducted in the WoS, SCOPUS, PsychINFO, Medline, Academic Search Ultimate, ProQuest, and PubPsych databases, complemented by a manual search on relevant websites and in the reference lists of the selected studies. Randomized controlled trials (RCTs) and quasi-RCTs of group-based psychodrama psychotherapy were included. The Effective Public Health Practice Project (EPHPP) tool was adopted to assess the methodological quality of the included studies. The search identified 14 RCTs and one quasi-RCT evaluating the effects of group-based psychodrama psychotherapy. The total number of participants in the studies was 642 people. Seven studies were conducted in Turkey, two in the USA, two in Finland, one in Canada, one in Brazil, one in Italy, and one in Iran. The heterogeneity of the issues analyzed indicates that psychodrama improves the symptoms associated with a wide range of problems. Despite psychodrama's long history, most clinical trials in this field have been published this century, which suggests not only that this psychotherapeutic practice remains relevant today but also that it continues to attract substantial interest among the scientific community. Nevertheless, further research efforts are required to understand its potential benefits for psychosocial well-being.
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Psicodrama , Psicoterapia de Grupo , Brasil , Canadá , Ensayos Clínicos Controlados como Asunto , Finlandia , Humanos , Irán , Italia , TurquíaRESUMEN
A acupuntura representa uma prática complementar de intervenção em saúde que aborda de modo integral e dinâmico o processo saúde-doença no ser humano, podendo ser usada isoladamente ou de forma integrada com outros recursos terapêuticos. Esta investigação consiste em uma revisão integrativa da literatura, realizada com o objetivo de analisar as evidências científicas acerca do uso de técnicas de acupuntura para o tratamento da lombalgia crônica não específica no Brasil. Para a elaboração da presente revisão integrativa, foram seguidas seis etapas: elaboração da questão norteadora; amostragem; extração dos dados dos estudos primários; avaliação dos estudos primários incluídos na revisão; análise e síntese dos resultados; apresentação da revisão integrativa. A busca nas bases de dados resultou, inicialmente, em 3552 estudos; desse total, nove (0,25%) estudos foram incluídos nesta revisão, atendendo aos critérios de inclusão. Um artigo foi publicado em 2006; um artigo foi publicado em 2015; um artigo foi publicado em 2016; dois artigos foram publicados em 2018 e quatro artigos foram publicados em 2020. Quanto ao tipo de população, um estudo foi realizado com idosos; um, com gestantes; um, com funcionários de uma cadeia pública feminina e seis estudos foram realizados com adultos entre 18 e 80 anos, todos portadores de lombalgia crônica não específica, no Brasil. Quanto ao nível de evidência, cinco estudos (56%) foram classificados no nível de evidências II por representarem estudos clínicos randomizados controlados e quatro estudos (44%) foram provenientes de ensaios clínicos não-randomizados, sendo classificados no nível de evidências III. Observou-se que a maioria dos estudos foram realizados utilizando a técnica de acupuntura sistêmica, seguida pela técnica de eletroacupuntura, acupuntura auricular e ventosaterapia. Os resultados de todos os estudos demonstraram a efetividade das técnicas de acupuntura para o tratamento da lombalgia crônica não específica, indicando melhora da intensidade da dor, da amplitude dos movimentos da região lombar e do quadro emocional geral do paciente, como diminuição de estresse e sintomas de ansiedade e depressão. Apesar da identificação da efetividade da acupuntura para o tratamento da lombalgia crônica não específica, considera-se fundamental a realização de um maior número de estudos clínicos baseados na utilização de protocolos rigorosos e internacionalmente reconhecidos para o uso destas práticas complementares, no intuito de comprovar a eficácia destes métodos de tratamento principalmente para o alívio da dor, na perspectiva da integralidade da saúde
Acupuncture represents a complementary practice of health intervention that comprehensively and dynamically addresses the health-disease process in humans, and can be used alone or in an integrated way with other therapeutic methods. This investigation consists of an integrative literature review, carried out with the aim of analyzing the scientific evidence about the use of acupuncture techniques for the treatment of chronic non-specific low back pain in Brazil. For the elaboration of this integrative review, six steps were followed: elaboration of the guiding question; sampling; extraction of data from primary studies; evaluation of the primary studies included in the review; analysis and synthesis of the results; presentation of the integrative review. The search in the databases resulted, initially, in 3552 studies; of this total, nine (0.25%) studies were included in this review, considering the inclusion criteria. One article was published in 2006; one article was published in 2015; one article was published in 2016; two articles were published in 2018 and four articles were published in 2020. As for the type of population, a study was carried out with the elderly; one, with pregnant women; one, with employees of a female public chain and six studies were carried out with adults between 18 and 80 years old, all with chronic non-specific low back pain, in Brazil. Related the level of evidence, five studies (56%) were classified at level of evidence II because they represented randomized controlled clinical trials and four studies (44%) came from non-randomized controlled clinical trials and were classified at level III of evidence. It was observed that most studies were carried out using the systemic acupuncture technique, followed by the electroacupuncture, auricular acupuncture technique and suction therapy. The results of all studies demonstrated the effectiveness of acupuncture techniques for the treatment of chronic non-specific low back pain, indicating improvement in pain intensity, range of motion in the lower back and the patient's general emotional condition, such as reduced stress and symptoms of anxiety and depression. Despite the identification of the effectiveness of acupuncture for the treatment of chronic non-specific low back pain, it is considered essential to carry out a greater number of clinical studies based on the use of rigorous and internationally recognized protocols for the use of these complementary practices, in order to prove the effectiveness of these treatment methods mainly for pain relief, from the perspective of comprehensive health
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Humanos , Terapia por Acupuntura , Dolor de la Región Lumbar/terapia , Dolor Crónico/terapia , Brasil , Salud Laboral , Ensayos Clínicos Controlados como AsuntoRESUMEN
ABSTRACT Objective: To evaluate the effect of virtual reality (VR) on dental anxiety, pain, and behaviour at different time points among children undergoing dental treatment under local anaesthesia. Material and Methods: This randomised, two‐armed, within-subject, cross-over, placebo-controlled trial included 76 children. Eligible participants were treated in two dental visits using the following methods: with protective glasses only, without distraction (attention placebo-controlled - APC); and with the treatment condition (i.e., VR). Primary outcomes were dental anxiety and pain; secondary outcome was dental visit behaviour. Heart rate scores were recorded as an objective measure to evaluate dental anxiety and pain. Subjective measurements for each variable were also performed. Results: Significant reduction in dental pain and anxiety was observed in the VR group, according to the heart rate scores; however, no statistical differences were observed according to the self-reported measures. Decreased dental anxiety and pain were associated with the first visit sequence with VR. Dental pain and anxiety scores were lower during local anaesthesia in the VR group than in the APC group. Conclusion: Virtual reality significantly reduced pain and anxiety during local anaesthesia in children undergoing dental treatment; therefore, it may be recommended during dental treatment in school-age children.
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Humanos , Masculino , Femenino , Niño , Odontalgia/diagnóstico , Niño , Ansiedad al Tratamiento Odontológico , Técnicas de Observación Conductual , Realidad Virtual , Turquía/epidemiología , Distribución de Chi-Cuadrado , Análisis de Varianza , Ensayos Clínicos Controlados como Asunto/métodos , Anestesia LocalRESUMEN
Objetivo Proporcionar una revisión de la literatura sobre la presencia de SARS-CoV-2 en los fluidos sexuales de pacientes con COVID-19 y su posible transmisión sexual de manera oportuna, rigurosa y continuamente actualizada. Fuentes de datos Realizaremos búsquedas en PubMed / Medline, Embase, Registro Cochrane Central de Ensayos Controlados (CENTRAL), literatura gris y en un repositorio centralizado en L · OVE (Living OVerview of Evidence). L · OVE es una plataforma que mapea las preguntas PICO a la evidencia de la base de datos Epistemonikos. En respuesta a la emergencia de COVID-19, L · OVE se adaptó para ampliar el rango de evidencia que cubre y se personalizó para agrupar todas las pruebas de COVID-19 en un solo lugar. La búsqueda cubrirá el período hasta el día anterior al envío a una revista. Criterios de elegibilidad para la selección de estudios y métodos Adaptamos un protocolo común ya publicado para múltiples revisiones sistemáticas paralelas a las especificidades de esta pregunta. Incluiremos ensayos aleatorios que evalúen la transmisión sexual del virus SARS-CoV-2. Se buscarán ensayos aleatorizados que evalúen la transmisión sexual de otros coronavirus, como MERS-CoV y SARS-CoV, y estudios no aleatorizados en COVID-19 en caso de que no se encuentre evidencia directa de ensayos aleatorizados, o si la evidencia directa proporciona una - o certeza muy baja para resultados críticos. Dos revisores evaluarán de forma independiente la elegibilidad de cada estudio, extraerán datos y evaluarán el riesgo de sesgo. Realizaremos metanálisis de efectos aleatorios y utilizaremos GRADE para evaluar la certeza de la evidencia para cada resultado. Una versión viva basada en la web de esta revisión estará disponible abiertamente durante la pandemia de COVID-19. Lo volveremos a enviar si las conclusiones cambian o hay actualizaciones sustanciales Registro PROSPERO (CRD42020189368).
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Humanos , Neumonía Viral/transmisión , Enfermedades Virales de Transmisión Sexual/transmisión , Infecciones por Coronavirus/transmisión , Betacoronavirus/aislamiento & purificación , Neumonía Viral/epidemiología , Proyectos de Investigación , Infecciones por Coronavirus/epidemiología , Ensayos Clínicos Controlados como Asunto , Revisiones Sistemáticas como AsuntoRESUMEN
Busulfan is given in the conditioning regimens preceding hematopoietic stem cell transplantation (HSCT), and plasma levels can be monitored. A targeted, individualized systemic exposure (SE) dose can be achieved by calculating the area under the plasma concentration versus time curve (AUC). The objective of this study was to determine a cutoff value for safety for the AUC for busulfan plasma levels in patients undergoing HSCT. A total of 149 consecutive HSCT patients were studied. After an oral test dose of busulfan, we set target doses of 4000, 5000, or 6000 µMol⸱min/day, and analyzed the AUC of oral or intravenous Bu. These patients were compared with 53 historical control subjects who had received myeloablative conditioning regimen without busulfan pharmacokinetic monitoring. Using a test dose and the administration route had no impact on the sinusoidal obstructive syndrome (SOS) incidence, transplant-related mortality or 1-year overall survival. However, patients receiving busulfan at doses set up at AUC > 5000 had an increased risk to develop SOS after HSCT (hazard ratio 3.39, p = 0.034, 95% CI 1.09-10.52). Adjusting the busulfan dose according to SE levels target dose during conditioning is associated with lower rates of oral severe mucositis and SOS. A cutoff of 5000 µMol⸱min is safe and does not impair survival.
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Busulfano/administración & dosificación , Busulfano/efectos adversos , Enfermedad Veno-Oclusiva Hepática/etiología , Acondicionamiento Pretrasplante/efectos adversos , Administración Intravenosa , Administración Oral , Adolescente , Área Bajo la Curva , Busulfano/farmacocinética , Niño , Preescolar , Ensayos Clínicos Controlados como Asunto , Susceptibilidad a Enfermedades , Femenino , Enfermedades Hematológicas/diagnóstico , Enfermedades Hematológicas/terapia , Trasplante de Células Madre Hematopoyéticas/efectos adversos , Enfermedad Veno-Oclusiva Hepática/diagnóstico , Enfermedad Veno-Oclusiva Hepática/epidemiología , Enfermedad Veno-Oclusiva Hepática/mortalidad , Humanos , Incidencia , Lactante , Recién Nacido , Masculino , Pronóstico , Acondicionamiento Pretrasplante/métodos , Adulto JovenRESUMEN
BACKGROUND: Achalasia is a neurodegenerative motility esophageal disorder characterized by failure of lower esophageal sphincter relaxation. The conventional treatment option for achalasia has been laparoscopic Heller myotomy (LHM). However, in 2010, Inoue et al. described peroral endoscopic myotomy (POEM), a minimally invasive procedure, as an alternative therapy. To date, some studies with small sample sizes have aimed to compare outcomes of LHM vs POEM. OBJECTIVE: Thus, the aim of this study is to perform a systematic review and meta-analysis to better evaluate the efficacy and safety of these two techniques. METHODS: Individualized search strategies were developed from inception through April 2019 in accordance with PRISMA guidelines. Variables analyzed included operative time, overall adverse events rate, post-procedure gastroesophageal reflux disease (GERD), hospitalization length, post-procedure pain score, and Eckardt Score reduction. RESULTS: Twelve cohort trials were selected, consisting of 893 patients (359 in POEM group and 534 in LHM.) No randomized clinical trials were available. There was no difference in operative time (MD= -10,26, 95% CI (-5,6 to 8,2), P<0.001) or Post-Operative Gastroesophageal Reflux (RD: -0.00, 95%CI: (-0.09, 0.09), I2: 0%). There was decreased length of hospital stay for POEM (MD: -0.6, 95% CI (-1.11, -0.09), P=0.02), and an increased mean reduction in Eckardt score in POEM patients (MD = -0.257, 95% CI: (-0.512 to -0.002), P=0.048), with similar rates of adverse events. CONCLUSION: POEM demonstrated similar results compared to laparoscopic Heller myotomy with regards to improvement of dysphagia, post-procedure reflux, and surgical time, with the benefit of shorter length of hospital stay. Therefore, POEM can be considered an option for patients with achalasia.
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Acalasia del Esófago/cirugía , Esofagoscopía/métodos , Miotomía/métodos , Ensayos Clínicos Controlados como Asunto , Humanos , Tiempo de Internación , Tempo Operativo , Resultado del TratamientoRESUMEN
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)
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Humanos , Femenino , Anciano , Testosterona/uso terapéutico , Posmenopausia/efectos de los fármacos , Depresores del Apetito/efectos adversos , Fenitoína/efectos adversos , Placebos/administración & dosificación , Psicotrópicos/efectos adversos , Tamoxifeno/efectos adversos , Testosterona/administración & dosificación , Testosterona/análisis , Testosterona/efectos adversos , Testosterona/farmacología , Fármacos Cardiovasculares/efectos adversos , Indometacina/efectos adversos , Hormona Liberadora de Gonadotropina/efectos adversos , Posmenopausia/fisiología , Ensayos Clínicos Controlados como Asunto , Antagonistas Colinérgicos/efectos adversos , Anticonceptivos Orales/efectos adversos , Disfunciones Sexuales Psicológicas/etiología , Disfunciones Sexuales Psicológicas/terapia , Danazol/efectos adversos , Consenso , Inhibidores de la Aromatasa/efectos adversos , Uso Fuera de lo Indicado , Inhibidores del Factor Xa/efectos adversos , Anfetaminas/efectos adversos , Antagonistas de los Receptores Histamínicos/efectos adversos , Antagonistas de Andrógenos/efectos adversos , Andrógenos/fisiología , Cetoconazol/efectos adversos , Narcóticos/efectos adversosRESUMEN
La dispepsia es una entidad patológica que designa cualquier alteración funcional asociada al aparato digestivo. Por lo general, la dispepsia es benigna y curablejunto a la necesidad de una atención integral y continuada. Se realizó este trabajo con el objetivo de evaluar la eficacia del masaje tuina en pacientes que padecen dispepsiafuncional. Se realizó un estudio de intervención de tipo ensayo clínico controlado, monocéntrico, aleatorizado, durante el período comprendido entre Enero 2018 -Febrero 2019. El universo estuvoconstituido por los pacientes con dispepsia funcional que acudieron alConsultorio Médico de la Familia 24, Policlínico Bayamo-Oeste quecumplieron los criterios de inclusión y exclusión. La muestra estuvo compuesta por 100 pacientes asignándose por el método aleatorio simple a través del Software Asarconformándose dos grupos de tratamientos. El grupo estudio recibió la técnica de masaje tuina en la consulta de Medicina Natural y Tradicional, el grupo control recibió práctica del sobador en su hogar. Para la validación estadística se utilizó la prueba de diferencias de proporciones para muestras independientes, tomando como regla la probabilidad calculada inferior e igual 0.05 (p ≤ 0.05). La respuesta terapéutica de ambos grupos a los 15 días de aplicada la técnica la respuesta terapéutica en ambos grupos fue similar para el grupo estudio 46 (92.2 por ciento) y el grupo control 43 (86.0 por ciento). La técnica de masaje tuina es tan eficaz como el sobado para el tratamiento de la dispepsia funcional(AU)
Dyspepsia is a pathological entity that designates any functional alteration associated with the digestive system. In general, dyspepsia is benign and curable along with the need for comprehensive and ongoing care. This work was carried out with the objective of evaluating the efficacy of tuina massage in patients suffering from functional dyspepsia. A randomized controlled, monocentric, clinical trial type intervention study was conducted during the period from January 2018 - February 2019. The universe consisted of patients with functional dyspepsia who attended the Family Medical Office 24, Bayamo Polyclinic. West that met the inclusion and exclusion criteria. The sample consisted of 100 patients assigned by the simple random method through the Asar Software, forming two groups of treatments. The study group received the technique of tuina massage in the consultation of Natural and Traditional Medicine, the control group received practice of the tiler in their home. For the statistical validation the test of differences of proportions for independent samples was used, taking as a rule the calculated probability lower and equal 0.05 (p ≤ 0.05). The therapeutic response of both groups 15 days after the technique was applied, the therapeutic response in both groups was similar for study group 46 (92.2 percent) and control group 43 (86.0 percent). The tuina massage technique is as effective as sobado for the treatment of functional dyspepsia(EU)