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Resúmenes Epistemonikos
Medwave 2017 Nov-Dic;17(9):e7119 doi: 10.5867/medwave.2017.09.7119
¿Son efectivos los cannabinoides para el manejo de náuseas y vómitos inducidos por quimioterapia?
Are cannabinoids effective for the management of chemotherapy induced nausea and vomiting?
Mariaignacia Morales, Oscar Corsi, José Peña
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Resumen

INTRODUCCIÓN
El tratamiento de las náuseas y vómitos inducidos por quimioterapia podría mejorar la calidad de vida de los pacientes oncológicos; para lograrlo se ha propuesto la adición de cannabinoides a los esquemas de antieméticos habituales.

MÉTODOS
Para responder esta pregunta utilizamos Epistemonikos, la mayor base de datos de revisiones sistemáticas en salud, la cual es mantenida mediante búsquedas en múltiples fuentes de información, incluyendo MEDLINE, EMBASE, Cochrane, entre otras. Extrajimos los datos desde las revisiones identificadas, reanalizamos los datos de los estudios primarios, realizamos un metanálisis y preparamos tablas de resumen de los resultados utilizando el método GRADE.

RESULTADOS Y CONCLUSIONES
Identificamos 16 revisiones sistemáticas que en conjunto incluyen 61 estudios primarios, de los cuales cuatro son ensayos aleatorizados que responden a la pregunta de interés. Concluimos que no hay claridad respecto a si los cannabinoides otorgan un beneficio al añadirlos a esquemas antieméticos habituales para el control de náuseas y vómitos inducidos por quimioterapia, porque la certeza de la evidencia es muy baja. Probablemente aumentan los efectos adversos de manera sustantiva.


 
Problema

Las náuseas y vómitos en relación al uso de quimioterapia corresponden a uno de los problemas más habituales y temidos por los pacientes oncológicos [1],[2]. Si bien en las últimas décadas se han incorporado nuevos fármacos para la prevención y tratamiento de la emesis, algunos pacientes no responden al manejo convencional [3]

Se ha propuesto el uso de cannabinoides (principio activo delta-9-tetrahidrocannabinol o análogos) como antiemético basándose en su efecto sobre los receptores de endocannabinoides CB1 ubicados en el sistema nervioso central y en su participación en la regulación del centro emético, por ejemplo, mediante receptores serotoninérgicos 5-HT3 [4],[5]. Sin embargo, del punto de vista clínico, aún es controvertido el rol de estas sustancias para el control de la emesis inducida por quimioterapia. 

Metodos

Para responder esta pregunta utilizamos Epistemonikos, la mayor base de datos de revisiones sistemáticas en salud, la cual es mantenida mediante búsquedas en múltiples fuentes de información, incluyendo MEDLINE, EMBASE, Cochrane, entre otras. Extrajimos los datos desde las revisiones identificadas y reanalizamos los  datos de los estudios primarios. Con esta información, generamos un resumen estructurado denominado FRISBEE (Friendly Summaries of Body of Evidence using Epistemonikos), siguiendo un formato preestablecido, que incluye mensajes clave, un resumen del conjunto de evidencia (presentado como matriz de evidencia en Epistemonikos), metanálisis del total de los estudios cuando sea posible, tablas de resumen de resultados con el método GRADE, y tabla de otras consideraciones para la toma de decisión.

Mensajes clave

  • No está claro si los cannabinoides agregan beneficio en el control de náuseas y vómitos inducidos por quimioterapia al añadirlos a esquemas de manejo habituales, porque la certeza de la evidencia es muy baja.
  • Probablemente el uso de cannabinoides se asocia a un aumento sustantivo en los efectos adversos.
Acerca del conjunto de evidencia para esta pregunta

Cuál es la evidencia
Véase matriz de evidencia en Epistemónikos más abajo.

Encontramos 16 revisiones sistemáticas [6],[7],[8],[9],[10],
[11],[12],[13],[14],[15],[16],[17],[18],[19],[20],[21] que
incluyen 61 estudios primarios reportados en 69 referencias 
[22],[23],[24],[25],[26],[27],[28],[29],[30],[31],[32],[33],[34],
[35],[36],[37],[38],[39],[40],[41],[42],[43],[44],[45],[46],[47],
[48],[49],[50],[51],[52],[53],[54],[55],[56],[57],[58],[59],[60],
[61],[62],[63],[64],[65],[66],[67],[68],[69],[70],[71],[72],[73],
[74],[75],[76],[77],[78],[79],[80],[81],[82],[83],[84],[85],[86],
[87],[88],[89],[90] de los cuales 58 referencias son ensayos aleatorizados [22],[23],[24],[25],[26],[27],[28],[29],[30],[31],
[32],[33],[34],[35],[36],[37],[38],[39],[40],[41],[42],[43],[44],
[45],[46],[47],[48],[49],[50],[51],[52],[53],[54],[55],[56],[57],
[58],[59],[60],[61],[62],[63],[64],[65],[66],[67],[68],[69],[70],
[71],[72],[73],[74],[75],[76],[77],[78],[79]. De ellos, 21 ensayos reportaron los desenlaces elegidos por los autores, y solo cuatro asociaron un tratamiento antiemético adicional a los cannabinoides. 

Este resumen analiza cuatro ensayos, reportados en ocho referencias [22],[23],[24],[25],[26],[27],[28],[29], que compararon cannabinoides versus placebo en pacientes que recibieron además un esquema antiemético asociado, reportando el control de náuseas y vómitos durante el período de intervención, que corresponde a la pregunta clínicamente relevante para los autores. 

Qué tipo de pacientes incluyeron los estudios*

Todos los ensayos seleccionados incluyeron población adulta de ambos sexos. También se incluyó población geriátrica, hasta los 81 años. 

Los pacientes incluidos en los estudios tenían tumores sólidos [22],[25], y sólidos o hematológicos [23],[24].

Respecto al riesgo de emesis, los ensayos incluyeron esquemas de quimioterapia de riesgo emético alto a moderado [22], sólo moderado [23],[25], y riesgo no clasificable [24] (éste último incluyó quimioterapias mayoritariamente de alto riesgo, pero también se incluyeron de riesgo bajo a mínimo). 

Tres de los cuatro ensayos reportaron si los pacientes habían usado previamente cannabinoides alguna vez, de ellos un ensayo contenía exclusivamente pacientes sin exposición previa [24], y dos ensayos contenían pacientes con y sin exposición previa [22],[25]

Qué tipo de intervenciones incluyeron los estudios*

Los cannabinoides estudiados fueron dronabinol (derivado sintético de tetrahidrocannabinol) en dosis máxima de 10 mg/día [22], 15 mg/día [23] o 40 mg/día [24] y nabiximol (extracto de tetrahidrocannabinol y cannabidiol) hasta 8 sprays en un periodo de 4 horas cada 24 horas [25]

Respecto al esquema antiemético asociado, dos ensayos incluyeron uso de corticoides más antagonistas 5HT-3 [22],[23]; un ensayo incluyó uso de corticoides asociados a antagonistas 5HT-3 o metoclopramida [25], y un ensayo incluyó sólo uso de proclorperazina [24].

Qué tipo de desenlaces midieron

En todos los ensayos se evaluó el control de náuseas y vómitos durante el período de estudio [22],[23],[24],[25] tanto respuesta parcial como completa. 

Tres de los cuatro ensayos incluidos [22],[24],[25] reportaron efectos adversos. 

Además, algunos  ensayos midieron desenlaces  tolerabilidad de la intervención (medido como abandono de tratamiento por efectos adversos), impacto de náuseas y vómitos en la calidad de vida, frecuencia, duración y severidad de náuseas y vómitos [22],[24],[25], porcentaje de pacientes y médicos satisfechos con la intervención [25], puntaje ECOG y calidad de vida [22]

Tres de los cuatro ensayos tuvieron un seguimiento de cinco días [22],[23],[25]y uno de seis días [24]

* La información sobre los estudios primarios es extraída desde las revisiones sistemáticas identificadas, no directamente desde los estudios, a menos que se especifique lo contrario.

Cuál es la evidencia

Véase matriz de evidencia en Epistemónikos más abajo.
Resumen de los resultados

La información sobre los efectos de cannabinoides para el control de náuseas y vómitos inducidos por quimioterapia está basada en cuatro ensayos aleatorizados que incluyeron 176 pacientes [22],[23],[24],[25]. Todos los ensayos midieron el control de náuseas y vómitos mientras que tres ensayos midieron el desarrollo de eventos adversos [22],[24],[25].

El resumen de los resultados es el siguiente:

  • No está claro si agregar cannabinoides a un esquema de manejo habitual de náuseas y vómitos inducidos por quimioterapia aumente el control de las náuseas y vómitos inducidos por quimioterapia porque la certeza de la evidencia es muy baja.
  • El uso de cannabinoides probablemente aumenta los efectos adversos de manera sustantiva en estos pacientes.

Otras consideraciones para la toma de decisión

A quién se aplica y a quién no se aplica esta evidencia

  • La evidencia presentada en este resumen aplica a pacientes adultos de ambos sexos, con tumores sólidos o hematológicos en tratamiento con quimioterapia de diverso riesgo emetogénico, mayoritariamente moderado a alto. Los pacientes incluidos recibieron distintos esquemas antieméticos a base de antagonistas 5HT-3, corticoides y/o proclorperazina, además de la intervención con cannabinoides.
Sobre los desenlaces incluidos en este resumen
  • Se incluyeron los desenlaces de respuesta completa a tratamiento - ausencia de náuseas y vómitos - y desarrollo de efectos adversos, ya que constituyen los desenlaces críticos para la toma de decisión de acuerdo a la opinión de los autores.
  • Hoy existen alternativas terapéuticas para el control de náuseas y vómitos inducidos por quimioterapia, de conocida efectividad y seguridad que son considerados el estándar de manejo. Por esto, los autores creen que el desenlace crítico debe ser medido en este escenario, comparando la adición de cannabinoides a esquemas de tratamiento habitual, y no meramente versus placebo; en concordancia con lo propuesto por Hesketh et al [91].
  • No se incluyeron desenlaces de respuesta parcial debido a la diversidad de escalas utilizadas por los distintos estudios para reportar severidad de náuseas y vómitos.
Balance riesgo/beneficio y certeza de la evidencia
  • Considerando que no está claro si añadir cannabinoides a un esquema habitual de antieméticos mejoraría el control de náuseas y vómitos por quimioterapia, y existe un aumento, probablemente sustantivo, en el riesgo de efectos adversos, el balance beneficio/riesgo no es favorable.
  • Por desgracia, muchos de los ensayos no reportan el desenlace de interés y solo reportan control parcial de los síntomas, lo cual no permite incluir una muestra de pacientes mayor, lo que repercute en la certeza de la evidencia existente.
  • De acuerdo a lo reportado en algunas de las revisiones incluidas en este trabajo [9],[12],[13],[14],[15], los efectos adversos pueden ser frecuentes y variados.
Consideraciones de recursos
  • Los cannabinoides para uso terapéutico en sus variadas presentaciones tienen, por lo general, un elevado precio en el mercado.
  • Dado que no está claro si los cannabinoides conllevan un beneficio en este escenario, no es posible realizar un adecuado balance costo/beneficio, aunque probablemente es desfavorable.
Qué piensan los pacientes y sus tratantes
  • Frente a la evidencia presentada en este resumen, la mayoría de los pacientes y tratantes deberían inclinarse en contra del uso de canabinoides para esta indicación. Sin embargo, aquellos que valoren la posibilidad de un beneficio incierto podrían decidir utilizar esta intervención en casos refractarios, por la ausencia de otras opciones terapéuticas, tal como sugieren algunas guías clínicas [92].
Diferencias entre este resumen y otras fuentes
  • Los resultados de este resumen son en general concordantes con las revisiones sistemáticas incluidas en nuestro resumen.
  • En general, las guías internacionales recomiendan distintos esquemas de antieméticos, en base a antagonistas de los receptores serotoninérgicos 5-HT3 y dexametasona según el riesgo de emesis del protocolo de quimioterapia. Otras intervenciones recomendadas son antagonistas de neurokinina-1 (NK1) y antipsicóticos (olanzapina) [92],[93], [94].
  • La guía de la National Comprehensive Cancer Network (NCNN) [92] y la guía de la European Society of Medical Oncology (ESMO) - Multinational Association of Supportive Care in Cancer (MASCC) proponen el uso de cannabinoides para el manejo de náuseas/vómitos refractarios o como terapia de rescate [93]. La guía de la American Society of Clinical Oncology (ASCO) [94] no emite una recomendación sobre el uso de cannabinoides.
¿Puede que cambie esta información en el futuro?
  • La probabilidad de que futuros estudios cambien las conclusiones de este resumen es alta, en especial en lo que respecta al posible beneficio, ya que la evidencia es de muy baja certeza.
  • En el registro de la International Controlled Trials Registry Platform se identificaron tres ensayos en curso [95],[96],[97]. En la base de datos del congreso de la American Society of Clinical Oncology (2012) se encuentra un abstract que responde esta pregunta clínica [98] y cuyos datos no están reportados dentro de las revisiones sistemáticas que encontramos. En el registro PROSPERO se identifica una revisión sistemática en curso [99].
  • Por otra parte, no encontramos estudios que incluyeran antagonistas del receptor de NK1 u olanzapina como parte del esquema antiemético basal o comparador, ambos fármacos con mayor grado de recomendación en las guías clínicas.
  • Las revisiones sistemáticas identificadas presentan limitaciones importantes respecto a los datos entregados sobre el potencial emetogénico y esquema de administración de cannabinoides. Eventualmente, una nueva revisión sistemática que incorpore nuevos datos o nuevos análisis podría aportar nuevas luces sobre esta pregunta.
Cómo realizamos este resumen

Mediante métodos automatizados y colaborativos recopilamos toda la evidencia relevante para la pregunta de interés y la presentamos en una matriz de evidencia.

Siga el enlace para acceder a la versión interactiva: Cannabinoides para las náuseas y vómitos inducidos por quimioterapia

Notas

Si con posterioridad a la publicación de este resumen se publican nuevas revisiones sistemáticas sobre este tema, en la parte superior de la matriz se mostrará un aviso de “nueva evidencia”. Si bien el proyecto contempla la actualización periódica de estos resúmenes, los usuarios están invitados a comentar en la página web de Medwave o contactar a los autores mediante correo electrónico si creen que hay evidencia que motive una actualización más precoz.

Luego de crear una cuenta en Epistemonikos, al guardar las matrices recibirá notificaciones automáticas cada vez que exista nueva evidencia que potencialmente responda a esta pregunta.

Este artículo es parte del proyecto síntesis de evidencia de Epistemonikos. Se elabora con una metodología preestablecida, siguiendo rigurosos estándares metodológicos y proceso de revisión por pares interno. Cada uno de estos artículos corresponde a un resumen, denominado FRISBEE (Friendly Summary of Body of Evidence using Epistemonikos), cuyo principal objetivo es sintetizar el conjunto de evidencia de una pregunta específica, en un formato amigable a los profesionales clínicos. Sus principales recursos se basan en la matriz de evidencia de Epistemonikos y análisis de resultados usando metodología GRADE. Mayores detalles de los métodos para elaborar este FRISBEE están descritos aquí (http://dx.doi.org/10.5867/medwave.2014.06.5997)

La Fundación Epistemonikos es una organización que busca acercar la información a quienes toman decisiones en salud, mediante el uso de tecnologías. Su principal desarrollo es la base de datos Epistemonikos (www.epistemonikos.org).

Declaración de conflictos de intereses

Los autores declaran no tener conflictos de intereses con la materia de este artículo.

Licencia Creative Commons Esta obra de Medwave está bajo una licencia Creative Commons Atribución-NoComercial 3.0 Unported. Esta licencia permite el uso, distribución y reproducción del artículo en cualquier medio, siempre y cuando se otorgue el crédito correspondiente al autor del artículo y al medio en que se publica, en este caso, Medwave.

 

INTRODUCTION
Nausea and vomiting are common side effects in cancer patients treated with chemotherapy. Proper control of these symptoms might improve quality of life in these patients. Addition of cannabinoids to standard antiemetic treatment has been proposed in order to improve control of these symptoms.

METHODS
To answer this question we used Epistemonikos, the largest database of systematic reviews in health, which is maintained by screening multiple information sources, including MEDLINE, EMBASE, Cochrane, among others. We extracted data from the systematic reviews, reanalyzed data of primary studies, conducted a meta-analysis and generated a summary of findings table using the GRADE approach.

RESULTS AND CONCLUSIONS
We identified 16 systematic reviews that include 61 primary studies. Out of these, four were randomized trials that answered our question. At present, given that the certainty of the evidence is very low, it is unclear whether the addition of cannabinoids to standard antiemetic regimes benefits patients with chemotherapy induced nausea and vomiting. Cannabinoids probably increase adverse effects substantively.

Autores: Mariaignacia Morales[1,2], Oscar Corsi[2,3], José Peña[1,2,4,5]

Filiación:
[1] Facultad de Medicina, Pontificia Universidad Católica de Chile, Santiago, Chile
[2] Proyecto Epistemonikos, Santiago, Chile
[3] Departamento de Medicina Interna, Facultad de Medicina, Pontificia Universidad Católica de Chile
[4] Departamento Hemato-Oncología, Facultad de Medicina, Pontificia Universidad Católica de Chile, Santiago, Chile
[5] Centro de Cáncer Nuestra Señora de la Esperanza, Red de Salud UC-Christus, Santiago, Chile

E-mail: jepena@uc.cl

Correspondencia a:
[1] Centro Evidencia UC
Pontificia Universidad Católica de Chile
Centro de Innovación UC Anacleto Angelini
Avda.Vicuña Mackenna 4860
Macul
Santiago
Chile

Citación: Morales M, Corsi O, Peña J. Are cannabinoids effective for the management of chemotherapy induced nausea and vomiting?. Medwave 2017 Nov-Dic;17(9):e7119 doi: 10.5867/medwave.2017.09.7119

Fecha de envío: 23/11/2017

Fecha de aceptación: 20/12/2017

Fecha de publicación: 28/12/2017

Origen: Este artículo es producto del Epistemonikos Evidence Synthesis Project de la Fundación Epistemonikos, en colaboración con Medwave para su publicación.

Tipo de revisión: Con revisión por pares sin ciego por parte del equipo metodológico del Epistemonikos Evidence Synthesis Project.

Ficha PubMed

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