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Resúmenes Epistemonikos
Medwave 2016; 16(Suppl2):e6972 doi: 10.5867/medwave.2017.6972
¿Son los cannabinoides un tratamiento efectivo para el dolor crónico no asociado a cáncer?
Are cannabinoids an effective treatment for chronic non-cancer pain?
Rubén F Allende-Salazar, Gabriel Rada
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Resumen

El uso de cannabinoides se ha propuesto como analgésico para dolores de diversa índole, en especial para pacientes con dolor crónico refractario al tratamiento habitual. Sin embargo, su real eficacia y seguridad sigue siendo motivo de controversia, por lo que buscamos determinar sus efectos en pacientes con dolor crónico no asociado a cáncer. 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. Identificamos 37 revisiones sistemáticas que en conjunto incluyen 41 estudios, de los que 32 son ensayos aleatorizados relevantes para nuestra pregunta. Extrajimos los datos desde las revisiones identificadas, reanalizamos los datos de los estudios primarios, realizamos un metaanálisis y preparamos tablas de resumen de los resultados utilizando el método GRADE. Concluimos que no está claro si los cannabinoides disminuyen el dolor en pacientes con dolor crónico no asociado a cáncer porque la certeza de la evidencia disponible es muy baja. Por otra parte, se asocian a efectos adversos importantes.


 
Problema

La cannabis ha sido utilizada desde hace siglos en forma recreativa y terapéutica para diversas condiciones, incluido el dolor. Sin embargo, desde la convención única de 1961 sobre estupefacientes de las Naciones Unidas, la cannabis ha sido objeto de una prohibición mundial y su uso ha sido limitado. Pese a esto, la investigación sobre sus usos terapéuticos llevó al descubrimiento de los receptores de endocannabinoides CB1 y CB2, los cuales mediante un mecanismo asociado a proteína G tendrían efecto en la reducción del dolor. Dado que muchos pacientes con dolor crónico de diversa índole mantienen su sintomatología a pesar de la terapia estándar, se ha propuesto que el uso de extractos de planta de cannabis sativa con los principios activos delta-9-tetrahidrocannabinol (THC) y cannabidiol (CBD), o sus análogos, podrían ser de ayuda. Diversos estudios han profundizado en esta premisa con diferentes resultados y han revelado varios efectos adversos asociados, desde síntomas gastrointestinales y neurológicos hasta síntomas psiquiátricos, por lo que la utilidad clínica de los cannabinoides aún no está clara. Dado este escenario, buscamos determinar si los cannabinoides constituyen un tratamiento eficaz y seguro para el dolor crónico no asociado a cáncer.

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 y reanalizamos los datos de los estudios primarios. Con esta información generamos un resumen estructurado, siguiendo un formato preestablecido, que incluye mensajes clave, un resumen del conjunto de evidencia (presentado como matriz de evidencia en Epistemonikos), metaanálisis del total de los estudios, 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 disminuyen el dolor en pacientes con dolor crónico no asociado a cáncer porque la certeza de la evidencia disponible es muy baja.
  • El uso de cannabinoides se asocia a una alta tasa de eventos adversos en pacientes con dolor crónico no asociado a cáncer.
  • Multiples estudios primarios en curso o revisiones sistemáticas de alta calidad reanalizando los datos existentes podrían entregar más certeza sobre estas conclusiones.
Acerca del conjunto de evidencia para esta pregunta

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

Encontramos 37 revisiones sistemáticas reportadas en 37 referencias [1],[2],[3],[4],[5],[6],[7],[8],[9],[10],[11],
[12],[13],[14],[15],[16],[17],[18],[19],[20],[21],[22],[23],
[24],[25],[26],[27],[28],[29],[30],[31],[32],[33],[34],[35],
[36],[37],
[38] que incluyen 41 estudios primarios reportados en 85 referencias [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],[91],[92],[93],[94],
[95],[96],[97],[98],[99],[100],[101],[102],[103],[104],[105],
[106],[107],[108],[109],[110],[111],[112],[113],[114],[115],
[116],[117],[118],[119],[120],[121],[122],[123] de los cuales 32 corresponden a ensayos controlados aleatorizados que compararon contra placebo, reportados en 72 referencias [39],[40],[42],[43],[44],[46],[47],[48],[49],
[50],[51],[52],[53],[54],[55],[56],[58],[59],[60],[61],[62],
[63],[64],[65],[66],[67],[68],[69],[70],[72],[75],[76],[77],
[78],[79],[80],[83],[84],[85],[86],[87],[88],[89],[90],[91],
[92],[93],[94],[96],[97],[98],[99],[100],[101],[102],[103],
[104],[105],[106],[108],[109],[110],[113],[114],[115],
[116],[117],[118],[119],[120],[121],[122],[123]. Esta tabla y el resumen en general se basan en estos últimos.

Qué tipo de pacientes incluyeron los estudios*

De los 32 ensayos que compararon cannabinoides contra placebo, nueve incluyeron pacientes con dolor neuropático de origen central [43],[58],[76],[78],[79],[87],[108],[113],[115], nueve incluyeron pacientes con esclerosis múltiple [42],[54],[77],[93],[102],[104],[106],[119],[122], cuatro incluyeron a pacientes con neuropatía diabética [61],[97],[103],[110], dos incluyeron a pacientes con neuropatía por VIH [39],[56], dos incluyeron a pacientes con dolor neuropático periférico de forma indiferenciada [99],[114], uno incluyó a pacientes con fibromialgia [100], uno incluyó a pacientes con dolor musculoesquelético [90], uno incluyó a pacientes con dolor crónico no asociado a cáncer de forma indiferenciada [85], uno incluyó  a pacientes con dolor de origen neurológico de forma indiferenciada [86], uno incluyó a pacientes con artritis reumatoide [46] y uno incluyó a pacientes con dolor asociado a espasticidad [117]

Qué tipo de intervenciones incluyeron los estudios*

Se usaron como intervención tanto cannabinoides extraídos desde Cannabis sativa (THC, CBD y combinaciones) como cannabinoides sintéticos (nabilona y ácido ajulémico) en distintas rutas de administración. Doce usaron nabiximol (Sativex®, THC y CBD) en spray oromucoso [42],[43],[46],
[61],[77],[79],[86],[87],[93],[97],[99],[106], seis nabilona oral [58],[90],[100],[103],[104],[117], cinco THC fumado [39],[54],[56],[113],[115], tres dronabinol (THC oral) [85],[102],[118], tres THC combinado con CBD oral [107],[119],[122], dos THC en spray oromucoso [43],[110], uno ácido ajulémico oral [76], uno CBD oral [78] y uno THC vaporizado [114].

Qué tipo de desenlaces midieron

El principal desenlace metanalizado fue la reducción de dolor de forma significativa (≥ 30%) evaluado en escala visual-análoga, escala numérica de 11 puntos o escala de dolor neuropático.

Otros desenlaces evaluados fueron reducción de dolor ≥ 50%, calidad de vida y presencia de efectos adversos gastrointestinales, del sistema nervioso central y psiquiátricos, entre otros.

* 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 los cannabinoides para reducción de dolor ≥ 30% está basado en 15 estudios aleatorizados que incluyen 1788 pacientes [39],[43],[56],[76],[77],[79],[86],[87],[93],[97],[99],[102],[113],[114],[115]. El resto de los estudios no reportó los desenlaces de interés, o ninguna revisión identificada logró extraer los datos de manera que pudieran ser incorporados a un metanálisis. La información sobre efectos adversos se basa en una revisión sistemática [37] que evalúa los efectos adversos de los cannabinoides en distintas poblaciones, e incluye 3489 pacientes en 29 estudios que reportan este desenlace.

El resumen de los resultados es el siguiente:

  • No está claro si los cannabinoides disminuyen el dolor en pacientes con dolor crónico no asociado a cáncer porque la certeza de la evidencia disponible es muy baja.
  • El uso de cannabinoides se asocia a una alta tasa de eventos adversos. La certeza de la evidencia es alta.

Siga el enlace para acceder a la versión interactiva de tabla iSoF

Otras consideraciones para la toma de decisión

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

  • Esta evidencia se aplica a adultos que cursan con dolor crónico no asociado a cáncer.
Sobre los desenlaces incluidos en este resumen
  • Se incluyeron los desenlaces críticos para la toma de decisión en este escenario clínico, de acuerdo a la opinión de los autores de este resumen. Estos coinciden con aquellos presentados en la mayoría de las revisiones identificadas, y las principales guías.
  • No incluímos en la tabla de resumen de resultados la reducción de dolor mayor o igual a 50% dado que no habría cambiado las conclusiones (RR 1,69 [IC 0,97 a 2,94]) y la muy baja certeza de la evidencia.
Balance riesgo/beneficio y certeza de la evidencia
  • No es posible realizar un adecuado balance riesgo/beneficio porque la certeza de la evidencia sobre la efectividad de los cannabinoides para el tratamiento del dolor crónico no asociado a cáncer es muy baja.  En vista que los efectos adversos son frecuentes, el balance riesgo/beneficio probablemente no favorece su utilización en estos pacientes.
Consideraciones de recursos
  • Los cannabinoides son en general de alto costo. En el caso de los fármacos sintéticos, el costo directo suele ser elevado. En el caso de cannabis, dada su prohibición, existen altos costos asociados a su producción, regulación y distribución.
Qué piensan los pacientes y sus tratantes
  • La evidencia existente debería llevar a la mayoría de los pacientes y tratantes a tener cautela en cuanto a la utilización de esta intervención. Sin embargo, dada la connotación que tienen las medicinas naturales y en particular la cannabis, es probable que tanto algunos tratantes como pacientes tenderán a favorecer su uso a pesar de la información entregada en este resumen.
Diferencias entre este resumen y otras fuentes
  • Las conclusiones de este resumen concuerdan con varias de las revisiones sistematicas incluídas [4],[7],[9],[10],[13],[14],[15],[17],[34]. Otras fueron más optimistas en cuanto al efecto analgésico de los cannabinoides [1],[5],[19],[22],[23],[24],[27],[30],[33],[36],[37], donde incluso tres [24],[36],[37] estiman que existe evidencia de calidad moderada para apoyar su uso. Una revision antigua desestima completamente la prescripción de cannabinoides [35], mientras que otras [2],[8],[25] desestiman su uso en base a su perfil de efectos adversos pese a admitir su efecto analgésico.
  • Existen al menos dos guías clínicas [124],[125] que concuerdan con los resultados de este artículo en cuanto a la poca certeza de la evidencia para entregar conclusiones sólidas. Por otro lado, existen guías clínicas de dolor neuropático que consideran a los cannabinoides como agentes analgésicos de segunda línea [126], de tercera línea [127], frente a fracaso de otras opciones [128], como analgésicos adyuvantes [129] o como alternativa a considerar especialmente en población con esclerosis múltiple [129]. Una guía de manejo de dolor crónico considera a los cannabinoides frente a fracaso de otras opciones [131], y una guía de manejo de fibromialgia los considera especialmente en pacientes con problemas de sueño [132].
¿Puede que cambie esta información en el futuro?
  • La probabilidad de que las conclusiones de este resumen acerca de los beneficios de los cannabinoides en pacientes con dolor crónico no asociado a cáncer cambien con futura evidencia es alta, dada la muy baja certeza de la evidencia.
  • Existen al menos tres estudios primarios [133],[134],[135], no incluídos en ninguna revisión sistemática hasta ahora, que evalúan el efecto analgésico de los cannabinoides en pacientes con dolor crónico no asociado a cáncer. Además, logramos identificar al menos ocho estudios en curso [136],[137],[138],[139],[140],[141],[142],[143] que podrían entregar información clínica relevante. 
  • Los estudios primarios en curso o revisiones sistemáticas de alta calidad reanalizando los datos existentes podrían entregar más certeza sobre estas conclusiones.
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 el dolor crónico no asociado a cáncer

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 Medwave o contactar a los autores mediante correo electrónico si creen que hay evidencia que motive una actualización más rápida.

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. El detalle de los métodos para elaborar este resumen 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).

Los resúmenes de evidencia siguen un riguroso proceso de revisión por pares interno.

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.

 

The use of cannabinoids has been proposed as an analgesic for different painful conditions, especially for chronic pain refractory to usual treatment. However, its real efficacy and safety remains controversial. We sought to determine whether cannabinoids are an effective treatment for chronic non-cancer pain. 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 identified 37 systematic reviews including 41 studies overall, of which 32 were randomized trials relevant for the question of interest. 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. We concluded it is not clear whether cannabinoids decrease pain in patients with chronic non-cancer pain because the certainty of available evidence is very low. On the other hand, they are associated with significant adverse effects.

Autores: Rubén F Allende-Salazar[1,2], Gabriel Rada[2,3,4,5,6]

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, Santiago, Chile
[4] Centro de Evidencia UC, Pontificia Universidad Católica de Chile, Santiago, Chile
[5] GRADE working group
[6] The Cochrane Collaboration

E-mail: radagabriel@epistemonikos.org

Correspondencia a:
[1] Facultad de Medicina
Pontificia Universidad Católica de Chile
Diagonal Paraguay 362
Santiago Centro
Chile.

Citación: Allende-Salazar RF, Rada G. Are cannabinoids an effective treatment for chronic non-cancer pain?. Medwave 2016; 16(Suppl2):e6972 doi: 10.5867/medwave.2017.6972

Fecha de envío: 27/5/2017

Fecha de aceptación: 6/6/2017

Fecha de publicación: 14/6/2017

Ficha PubMed

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