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Universidad Peruana De Ciencias Aplicadas Facultad Eficacia y seguridad de los estilbenos en el manejo de la sintomatología climatérica en mujeres de edad mediana: Una revisión sistemática Item Type info:eu-repo/semantics/bachelorThesis Authors Villanueva Alvarado, Aryana Leonor; Trabucco Puicón, Claudia Estefany Publisher Universidad Peruana de Ciencias Aplicadas (UPC) Rights info:eu-repo/semantics/openAccess; Attribution- NonCommercial-ShareAlike 4.0 International Download date 24/09/2021 23:04:51 Item License http://creativecommons.org/licenses/by-nc-sa/4.0/ Link to Item http://hdl.handle.net/10757/655345 UNIVERSIDAD PERUANA DE CIENCIAS APLICADAS FACULTAD DE CIENCIAS DE LA SALUD PROGRAMA ACADÉMICO DE MEDICINA Eficacia y seguridad de los estilbenos en el manejo de la sintomatología climatérica en mujeres de edad mediana: Una revisión sistemática. TESIS Para optar el título profesional de Médico Cirujano AUTOR(ES) Villanueva Alvarado, Aryana Leonor (0000-0003-4013-7223) Trabucco Puicón, Claudia Estefany (0000-0001-8963-7187) ASESOR(ES) Mezones Holguín, Edward (0000-0001-7168-8613) Lima, 13 de febrero del 2021 DEDICATORIA A nuestros padres, por su apoyo incondicional a lo largo de esta carrera. A ellos les debemos este mérito, así como cualquier éxito pasado y futuro. I AGRADECIMIENTOS Agradecemos a Josmel Pacheco, experto en gestión del conocimiento, por el tiempo y la paciencia dedicados a la validación de las estrategias de búsqueda, y a nuestro asesor Edward Mezones-Holguín, por su apoyo, tiempo, paciencia y dedicación en la elaboración de este proyecto. II RESUMEN Objetivo: Sintetizar la evidencia primaria con respecto a la eficacia y seguridad de los estilbenos en el tratamiento de la sintomatología climatérica en las mujeres de edad mediana. Métodos: Llevamos a cabo una revisión sistemática de la literatura según las recomendaciones del Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA). Realizamos la búsqueda primaria en Pubmed-Medline, Embase, Scopus, Web of Science, WOS-Medline, LILACS, CINAHL, PsycINFO, SciELO, CENTRAL y en registros internacionales de ensayos clínicos, sobre la eficacia y seguridad de los estilbenos en sintomatología climatérica. Consultamos fuentes de literatura gris, hasta diciembre del 2018, sin restricción de idioma. Usamos la herramienta de la Colaboración Cochrane para la evaluación de riesgo de sesgo de los estudios incluidos. Resultados: Obtuvimos 2752 registros en la búsqueda primaria, a partir de los cuales seleccionamos cuatro ensayos clínicos controlados aleatorizados (ECAs) que reportaron desenlaces de eficacia y seguridad. Existe alta heterogeneidad entre los estudios en cuanto a la dosis, combinaciones con otros fitoestrógenos, duración de la suplementación, escalas de medición y reporte de desenlaces. En cuanto a la eficacia, un estudio reportó disminución significativa en todos los síntomas somáticos, en el grupo con resveratrol, con mayor reducción en el ítem de molestias musculares y articulares, donde solo el 16.7% de la población reportó estas molestias al final de la intervención, comparado a un 73.3% del brazo placebo (p<0.001). Por otro lado, un segundo estudio demostró mejoría significativa en el número (p=0.0077) e intensidad (p=0.018) de los episodios vasomotores en el grupo de la intervención. En contraparte, un tercer estudio mostró diferencias no significativas en el puntaje total de la subescala somática (7.7 ± 2.2; p ITT= 0.760) para el grupo de la intervención y (8.6 ± 2.2; p ITT= 0.760) para el grupo control. En relación a la eficacia de los estilbenos en sintomatología urogenital y psicológica, los resultados fueron contradictorios. En términos de seguridad, dos de los cuatro ECAs reportaron la ausencia de eventos adversos con la suplementación de resveratrol. Conclusión: La evidencia proveniente de los ECAs incluidos no es concluyente con respecto a la eficacia en la suplementación con estilbenos, particularmente con resveratrol, en el manejo de la sintomatología climatérica. Los ensayos clínicos reportaron la ausencia de eventos adversos con la suplementación de resveratrol, aunque este desenlace fue evaluado III solo en la mitad de los estudios. Por ello, se requiere llevar a cabo futuros ensayos clínicos aleatorizados con un mejor diseño y mayor muestra, con el fin de alcanzar una conclusión definitiva sobre el uso de estilbenos. Palabras clave: menopausia; estilbenos; resveratrol; sintomatología climatérica; revisión sistemática (Fuente: DECS) IV Efficacy and safety of stilbenes for the management of climacteric symptoms in middle- aged women: a systematic review ABSTRACT Objective: To synthesize the evidence regarding the efficacy and safety of stilbenes to treat climacteric symptoms in middle-aged women. Methods: We conducted a systematic literature review according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. We searched in Pubmed-Medline, Embase, Scopus, Web of Science, WOS-Medline, LILACS, CINAHL, PsycINFO, SciELO, CENTRAL and international registries of clinical trials, about the efficacy and safety of stilbenes in climacteric symptomatology. We consulted grey literature sources, until December 2018, without language restriction. We used the Cochrane Collaboration tool for risk of bias assessment of the included studies. Results: We obtained 2752 records in the primary search, from which we selected four randomized controlled trials (RCTs) that reported efficacy and safety outcomes. We found that the included clinical trials were highly heterogeneous in terms of dose, combinations with other phytoestrogens, duration of supplementation, measurement scales, and outcome reporting. Regarding efficacy, one trial reported a significant decrease in all somatic symptoms in the resveratrol group, with the most significant reduction in muscular and joint discomfort, where only 16.7% of the population reported these symptoms at the end of the intervention, compared to 73.3% for the placebo arm (p<0.001). On the other hand, a second RCT showed significant improvement in the number (p=0.0077) and intensity (p=0.018) of vasomotor episodes in the intervention group. In contrast, a third trial showed non- significant differences in the somatic subscale total score, (7.7 ± 2.2; p ITT= 0.760) for the intervention group and (8.6 ± 2.2; p ITT= 0.760) for the control group. In terms of safety, two of four RCTs reported the absence of adverse events with resveratrol supplementation. Conclusion: Evidence from included RCTs is inconclusive regarding the efficacy of stilbene supplementation, particularly resveratrol, to manage climacteric symptomatology. Clinical trials reported the absence of adverse events with resveratrol supplementation, although this outcome was assessed in only half of the studies. Thus, future randomized clinical trials with V a better design and larger sample are required to reach a definitive conclusion on stilbenes's use. Keywords: Menopause; stilbenes; resveratrol; climacteric symptoms; systematic review (Source: MeSH-NLM) VI TABLA DE CONTENIDO 1. INTRODUCCIÓN ....................................................................................................... 1 2. MÉTODOS ................................................................................................................... 3 2.1 TIPO DE ESTUDIO .................................................................................................... 3 2.2 ELEGIBILIDAD DE LOS ESTUDIOS ............................................................................. 3 2.3 MEDICIÓN DE LOS DESENLACES .............................................................................. 3 2.3.1 Desenlaces Primarios ..................................................................................... 3 2.3.2 Desenlaces Secundarios ................................................................................. 3 2.4 ESTRATEGIA DE BÚSQUEDA .................................................................................... 3 2.5 SELECCIÓN DE ARTÍCULOS Y EXTRACCIÓN DE DATOS ............................................. 4 2.6 EVALUACIÓN DE RIESGO DE SESGO ......................................................................... 4 2.7 ANÁLISIS ESTADÍSTICO ........................................................................................... 5 2.8 MANEJO DE DATOS AUSENTES ................................................................................ 5 3. RESULTADOS ............................................................................................................ 6 3.1 CARACTERÍSTICAS GENERALES DE LOS ESTUDIOS ................................................... 6 3.2 DESENLACES PRIMARIOS ........................................................................................ 6 3.2.1 Eficacia en síntomas climatéricos medida por MRS ..................................... 6 3.2.2 Eficacia en síntomas somáticos ..................................................................... 6 3.2.3 Eficacia en síntomas urogenitales.................................................................. 7 3.2.4 Eficacia en síntomas psicológicos ................................................................. 7 3.2.5 Seguridad ....................................................................................................... 7 3.3 DESENLACES SECUNDARIOS ................................................................................... 7 3.3.1 Calidad de vida .............................................................................................. 7 3.3.2 Sintomatología depresiva
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