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

Authors

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

Keywords:

Placebo, Crossover randomised controlled trials, Spinal cord stimulation, Systematic review, Meta-analysis

Abstract

The aims of this reviewwere to systematically identify the current evidence base of placebo (or “sham”) randomised controlled trials (RCTs) of spinal cord stimulation (SCS) for neuropathic pain and to undertake a meta-analysis to investigate the effectiveness of SCS when compared with a placebo comparator arm. Electronic databases were searched frominception until January 2019 for RCTs of SCS using a placebo/sham control. Searches identified 8 eligible placebo-controlled randomised trials of SCS for neuropathic pain. Meta-analysis shows a statistically significant reduction in pain intensity during the active stimulation treatment periods compared with the control treatment periods, pooledmean difference 21.15 (95% confidence interval 21.75 to 20.55, P50.001) on a 10-point scale. Exploratory study–level subgroup analysis suggests a larger treatment effect in RCTs using a placebo control (defined as studies where the device was inactive and at least one of the study procedures was different between the arms) than a sham control (defined as all study procedures being equal between arms including SCS device behaviour). Our findings demonstrate limited evidence that SCS is effective in reducing pain intensitywhen comparedwith a placebo intervention. Our analyses suggest that themagnitude of treatment effect varies across trials and, in part, depends on the quality of patient blinding and minimisation of carryover effects. Improved reporting and further methodological research is needed into placebo and blinding approaches in SCS trials. Furthermore, we introduce a differentiation between placebo and sham concepts that may be generalisable to trials evaluating surgical or medical procedures.

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