Rev. Soc. Esp. Dolor. 2020; 27(1): 16-23 / DOI: 10.20986/resed.2020.3727/2019
José Carlos Roche
ABSTRACT
Introduction: There is a growing concern among clinicians and researchers that many results published in scientific journals are false positives.
Objective: To determine the value of evidence or integrity of the body of the published literature on the efficacy of pregabalin, gabapentin and duloxetine in the treatment of neuropathic pain.
Methods: A literature search was conducted selecting randomized clinical trials that evaluated the efficacy of pregabalin, gabapentin and duloxetine in neuropathic pain. The p-curve analysis of the studies with statistically significant results was applied to study their distribution.
Results: It was demonstrated that there was a significant asymmetry to the right in the p-curve of the three drugs (continuous test p <0.0001) confirming the value of evidence from the studies.
Conclusions: Clinicians, scientists and scientific publications should be aware of the growing problem with "p-hacking" and its harmful effects. All parties share the responsibility to maintain the scientific integrity of the published literature.
RESUMEN
Introducción: Existe una preocupación creciente entre los clínicos y los investigadores de que muchos resultados publicados en revistas científicas se tratan de falsos positivos.
Objetivo: Determinar el valor de evidencia o integridad del cuerpo de la literatura publicada sobre la eficacia de pregabalina, gabapentina y duloxetina en el tratamiento del dolor neuropático.
Métodos: Se realizó una búsqueda bibliográfica seleccionando ensayos clínicos aleatorizados que evaluaban la eficacia de pregabalina, gabapentina y duloxetina en dolor neuropático. Se aplicó el análisis de curva-p de los estudios con resultados estadísticamente significativos para estudiar su distribución.
Resultados: Se demostró que existía una asimetría significativa a la derecha en la curva-p de los tres fármacos (test continuo p < 0,0001) confirmando el valor de evidencia de los estudios.
Conclusiones: Los clínicos, los científicos y las publicaciones científicas deben ser conscientes del problema creciente con el “p-hacking” y sus efectos perjudiciales. Todas las partes comparten la responsabilidad en mantener la integridad científica de la literatura publicada.
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Bibliografía
1. Baron R, Binder A, Wasner G. Neuropathic pain: diagnosis, pathophysiological mechanisms, and treatment. Lancet Neurol. 2010;9(8):807-19.
2. Attal N, Lanteri-Minet M, Laurent B, Fermanian J, Bouhassira D. The specific disease burden of neuropathic pain: Results of a French nationwide survey. Pain. 2011;152(12):2836-43.
3. Doth AH, Hansson PT, Jensen MP, Taylor RS. The burden of neuropathic pain: a systematic review and meta-analysis of health utilities. Pain. 2010;149(2):338-44.
4. Langley PC, Van LC, Cappelleri JC, Carroll D. The burden associated with neuropathic pain in Western Europe. J Med Econ. 2013;16(1):85-95.
5. Moore RA, Wiffen PJ, Derry S, Toelle T, Rice AS. Gabapentin for chronic neuropathic pain and fibromyalgia in adults. Cochrane Database Syst Rev. 2014;(4):CD007938. DOI: 10.1002/14651858.CD007938.pub3.
6. Moore RA, Straube S, Wiffen PJ, Derry S, McQuay HJ. Pregabalin for acute and chronic pain in adults. Cochrane Database Syst Rev. 2009;(3):CD007076.
7. Lunn MP, Hughes RA, Wiffen PJ. Duloxetine for treating painful neuropathy, chronic pain or fibromyalgia. Cochrane Database Syst Rev. 2014;(1):CD007115.
8. Finnerup NB, Attal N, Haroutounian S, McNicol E, Baron R, Dworkin RH, et al. Pharmacotherapy for neuropathic pain in adults: systematic review, meta-analysis and updated NeuPSIG recommendations. Lancet Neurol. 2015;14(2):162-73.
9. Torrance N, Ferguson JA, Afolabi E, Bennett MI, Serpell MG, Dunn KM, et al. Neuropathic pain in the community: more under-treated than refractory? Pain. 2013;154(5):690-9.
10. Ioannidis JPA. Why most discovered true associations are inflated. Epidemiology. 2008;19(5):640-8.
11. Fanelli D. Negative results are disappearing from most disciplines and countries. Scientometrics. 2012;90(3):891-904.
12. Simonsohn U, Nelson LD, Simmons JP. P-curve: a key to the file-drawer. J Exp Psychol Gen. 2014;143(2):534-47.
13. Simmons JP, Nelson LD, Simonsohn U. False-positive psychology: undisclosed flexibility in data collection and analysis allows presenting anything as significant. Psychol Sci. 2011;22(11):1359-66.
14. Gadbury GL, Allison DB. Inappropriate fiddling with statistical analyses to obtain a desirable p-value: tests to detect its presence in published literature. PLoS One. 2012;7(10):e46363.
15. Nuzzo R. Scientific method: statistical errors. Nature. 2014;506(7487):150-2.
16. Siddall PJ, Cousins MJ, Otte A, Griesing T, Chambers R, Murphy TK. Pregabalin in central neuropathic pain associated with spinal cord injury: a placebo-controlled trial. Neurology 2006;67(10):1792-800.
17. Cardenas DD, Nieshoff EC, Suda K, Goto S, Sanin L, Kaneko T, et al. A randomized trial of pregabalin in patients with neuropathic pain due to spinal cord injury. Neurology 2013;80(6):533-9.
18. Lesser H, Sharma U, LaMoreaux L, Poole RM. Pregabalin relieves symptoms of painful diabetic neuropathy: a randomized controlled trial. Neurology. 2004;63(11):2104-10.
19. Richter RW, Portenoy R, Sharma U, Lamoreaux L, Bockbrader H, Knapp LE. Relief of painful diabetic peripheral neuropathy with pregabalin: a randomized, placebo-controlled trial. J Pain. 2005;6(4):253-60.
20. Rosenstock J, Tuchman M, LaMoreaux L, Sharma U. Pregabalin for the treatment of painful diabetic peripheral neuropathy: a double-blind, placebo-controlled trial. Pain. 2004;110(3):628-38.
21. Freynhagen R, Strojek K, Griesing T, Whalen E, Balkenohl M. Efficacy of pregabalin in neuropathic pain evaluated in a 12-week, randomised, double-blind, multicentre, placebo-controlled trial of flexible- and fixeddose regimens. Pain. 2005;115(3):254-63.
22. Dworkin RH, Corbin AE, Young JP Jr., Sharma U, LaMoreaux L, Bockbrader H, et al. Pregabalin for the treatment of postherpetic neuralgia: a randomized, placebo-controlled trial. Neurology. 2003;60(8):1274-83.
23. Sabatowski R, Galvez R, Cherry DA, Jacquot F, Vincent E, Maisonobe P, et al. 1008-045 Study Group. Pregabalin reduces pain and improves sleep and mood disturbances in patients with post-herpetic neuralgia: results of a randomised, placebo controlled clinical trial. Pain. 2004;109(1-2):26-35. DOI: 10.1016/j.pain.2004.01.001.