Revisión Sistemática y Metaanálisis de Ensayos Randomizados Controlados con Placebos/Procedimiento Simulado, sobre La Estimulación de La Médula Espinal para El Dolor Neuropático.: Publicado originalmente en la Revista Pain 2020; 161: 24-35. Traducción: Dr. Pablo Graff.

Rui V. Duarte; Sarah Nevitt; Ewan McNicol; Rod S. Taylor; Eric Buchser; Richard B. North; Sam Eldabe

doi:10.47924/neurotarget202178

Autores/as

Rui V. Duarte Liverpool Reviews and Implementation Group, University of Liverpool, Liverpool, United Kingdom.
Sarah Nevitt Liverpool Reviews and Implementation Group, University of Liverpool, Liverpool, United Kingdom.
Ewan McNicol Department of Pharmacy Practice, MCPHS University, Boston, MA, United States.
Rod S. Taylor Institute of Health and Well Being, University of Glasgow, Glasgow, United Kingdom.
Eric Buchser Anaesthesia and Pain Management Department, EHC-Hopital De Morges, Morges, Switzerland.
Richard B.North Neurosurgery, Anesthesiology and Critical Care Medicine (ret.), Johns Hopkins University School of Medicine, Baltimore, MD, United States.
Sam Eldabe Department of Pain Medicine, The James Cook University Hospital,Middlesbrough, United Kingdom.

DOI:

https://doi.org/10.47924/neurotarget202178

Palabras clave:

Placebo, Ensayos controlados aleatorios cruzados, Estimulación de la médula espinal, Análisis sistemático, Metaanálisis

Resumen

Los objetivos de esta revisión han sido identificar, sistemáticamente, la evidencia actual de ensayos con placebo aleatorios controlados (RCTs-Randomised Controlled Trials) de la estimulación de la médula espinal (SCS- Spinal Cord Stimulation por sus siglas en inglés) para el dolor neuropático y emprender un metaanálisis con el objeto de investigar la efectividad de SCS comparada con un grupo de estudio controlado. Se realizaron búsquedas en bases de datos electrónicas desde el inicio hasta enero de 2019 para RCTs y SCS, utilizando un control con placebo. Las búsquedas identificaron 8 ensayos con placebo aleatorios controlados de estimulación de la médula espinal aptos para el dolor neuropático. El metaanálisis muestra una reducción estadísticamente significativa en la intensidad del dolor durante los períodos de tratamiento de estimulación activa, en contraste con los períodos de tratamiento controlado, con una diferencia media agrupada de 21.15 (intervalo de confianza de 95% 21.75 a 20.55, P 50.001) sobre una escala de 10 puntos. Un análisis basado en un estudio a nivel de un subgrupo sugiere mayor efecto del tratamiento en RCTs utilizando un control con placebo (definido como estudios en los que el dispositivo estaba inactivo y al menos uno de los procedimientos del estudio fue diferente entre los grupos) en comparación con una simulación controlada (definido como que todos los procedimientos del estudio son iguales entre los grupos, incluido el comportamiento del dispositivo SCS). Nuestros hallazgos demuestran evidencia limitada de que la SCS es efectiva en la reducción de la intensidad de dolor en contraste con una intervención con placebo. Nuestros análisis sugieren que la magnitud del efecto del tratamiento varía a lo largo de los ensayos y, en parte, depende de la calidad del enmascaramiento al paciente y la minimización de los efectos remanentes. En los ensayos basados en SCS se requieren informes mejorados y mayor investigación metodológica sobre los enfoques de placebo y enmascaramiento. Adicionalmente, introducimos una diferenciación entre los conceptos de placebo y simulación que podrían ser generalizables a ensayos que evalúen tratamientos quirúrgicos o médicos.

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