Efecto placebo en la medicina contemporánea

Lázaro Gómez Fernández

Texto completo:

PDF

Resumen

Objetivo: Explicar el concepto de placebo y efecto placebo, así como otros procesos vinculados con la respuesta terapéutica.

Adquisición de la evidencia: Se realizó una búsqueda bibliográfica en las bases de datos PubMed, Scopus y EMBASE hasta mayo 2020. Se utilizaron las palabras clave: “placebo”, “placebo effect”, “placebo response”, “placebo intervention”. Se seleccionaron 107 artículos en idioma inglés y español: revisión (35), ensayos clínicos (26), metaanálisis y revisiones sistemáticas (10), que abordaban aspectos metodológicos sobre el uso y el efecto del placebo. Se excluyeron 36 artículos por presentar diversos errores metodológicos.

Resultados: El efecto placebo está presente en intervenciones farmacológicas y no farmacológicas. En él influyen la expectativa del paciente, mecanismos de condicionamiento pavloviano, el aprendizaje y las características del tratamiento. El uso de placebos puede ser responsable de una mejoría de hasta un 60% de los síntomas en los enfermos. Existen también otros procesos que modulan la respuesta al tratamiento, como la observación (Hawthorne), la regresión a la media, la evolución natural de la enfermedad y el efecto Pygmalion. El desarrollo de ensayos clínicos bien diseñados es la clave para avalar la introducción exitosa de nuevos tratamientos.

Conclusiones: El placebo es cualquier sustancia o intervención inerte, utilizada con intención curativa. El efecto placebo consiste en la mejoría de los síntomas que resulta del uso de un placebo. La observación experimental, la regresión a la media y la evolución natural de la enfermedad, son factores que influyen en la apreciación de la respuesta terapéutica.

Palabras clave

placebo; efecto placebo; respuesta placebo; intervención placebo

Referencias

Walach H. Placebo controls: historical, methodological and general aspects. Philos Trans R Soc Lond B Biol Sci. 2011;366:1879-88.

Schott H. On the history of the placebo effect: a brief outline. J Clin Med Sci. 2018;2(1):1-3.

Kirsch I. Placebo Effect in the Treatment of Depression and Anxiety. Clin Drug Investig. 2019;39(10):917-26.

de Craen AJ, Kaptchuk TJ, Tijssen JP, Kleijnen J. Placebos and placebo effects in medicine: historical overview. J Roy Soc Med. 1999;92(10):511-5.

Piñero JM. Paracelsus and his work in 16th and 17th century. Spain Clio Med. 1973;8:113-41.

Nutton V. The fatal embrace: Galen and the history of ancient medicine. Sci Context. 2005;18(1):111-21.

Bhatt A. Evolution of clinical research: a history before and beyond James Lind. Perspect Clin Res. 2010;1(1):6-10.

Motherby G. A new medical dictionary, 2d ed. ed. London: Lonfon, J. Jhonson; 1785.

Dolan JP, Holmes GR. Some important epochs in medicine. South Med J. 1984;77:1022-6.

Benson H, Friedman RS. Harnessing the power of the placebo effect and renaming it “remembered wellnes. Annu Rev Med. 1996;47:193-9.

Amberson JBM, Pinner M. A clinical trial of Sanocrysin in pulmonary tuberculosis. Am Rev Tuberc. 1931;24:401-35.

WMA. Declaración de Helsinski de la Asociación Médica Mundial. Principios éticos para las investigaciones médicas en seres humanos. 64 Asamblea General, Brasil. mayo 2015 [citado: 20/05/2020]. Disponible en: http://www.wma.net/es/que-hacemos/etica-medica/declaracion-de-helsinki/.

Real Academia Española. Diccionario de la Lengua Española. 23.ª ed. Madrid: RAE. [citado: 20/05/2020]. Disponible en: https://dle.rae.es/placebo.

Colloca L, Barsky AJ. Placebo and Nocebo Effects. N Engl J Med. 2020;382(6):554-61.

Zion SR, Crum AJ. Mindsets Matter: A New Framework for Harnessing the Placebo Effect in Modern Medicine. International Review of Neurobiology. 2018;138:137-60.

Goldenholz DM, Moss R, Scott J, Auh S, Theodore WH. Confusing placebo effect with natural history in epilepsy: A big data approach. Ann Neurol. 2015;78(3):329-36.

Weimer KE. Traditional and Innovative Experimental and Clinical Trial Designs and Their Advantages and Pitfalls. In: Bennedetti FE, Erick P, Frisaldi E, Schedlowski M, eds. Handbook of experimental pharmacology Placebo. London: Springer, 2004:238-56.

Salanti G, Chaimani A, Furukawa TA. Impact of placebo arms on outcomes in antidepressant trials: systematic review and meta-regression analysis. Schizophr Bull. 2019;45(2):680-8.

Razza LB, Moffa AH, Moreno ML. A systematic review and meta-analysis on placebo response to repetitive transcranial magnetic stimulation for depression trials. J Am Coll Nutr. 2018;81(3):105-13.

Parsons HM. What happened at Hawthorne?: New evidence suggest the Hawthorne effect resulted fron operant reinforcement contingencies. Science (New York, NY). 1974;183:922-32.

McCarney R, Warner J, Iliffe S, van Haselen R, Griffin M, Fisher P. The Hawthorne Effect: a randomised, controlled trial. Chin J Integr Med. 2007;13(2):103-8.

Andres EB, Song W, Johnston JM. Can hospital accreditation enhance patient experience? Longitudinal evidence from a Honk Kong hospital patient experience survey. BMC Health Serv Res. 2019;19(623). Disponible en: http://doi.org/10.1186/s12913-019-4452-z.

Barnett M, Olenski A, Jena AB. Patient Mortality During Unannounced Accreditation Surveys at US Hospitals. JAMA Intern Med. 2017;177(5):693-700.

Donatella De Amici D, Klersy K, Ramajoli F, Politi P. Impact of the Hawthorne Effect in a Longitudinal Clinical Study: The Case of Anesthesia. Controlled Clinical Trials. 2000;21(2):103-14.

Ardestani MM1, Hornby TG2. Effect of investigator observation on gait parameters in individuals with stroke. Biomech. 2020 Feb 13;100:109602. Doi: 10.1016/j.jbiomech.2020.109602.

Rosenthal RL, Jacobson L. Pygmalion in the classroom: teacher expectation and pupils´ intellectual development. Enl. Ed. New York: rvington Publishers 1992.

Czerniak E, Oberlander TF, Weimer K, Kossowsky J, Enck P. Placebo by Proxy and Nocebo by Proxy in Children: A Review of Parents' Role in Treatment Outcomes. Front Psychiatry. 2020;11:169. Doi: 10.3389/fpsyt.2020.00169.

Zilcha-Mano S, Wang Z, Peterson BS. Neural mechanisms of expectancy-based placebo effects in antidepressant clinical trials. J Psych Res. 2019;116(7):802-9.

Vase L, Baad-Hansen L, Pigg M. How May Placebo Mechanisms Influence Orofacial Neuropathic Pain? Am J Geriatr Psychiatry. 2019;27(2):920-31.

Tu Y, Park J, Ahlfors SP. A neural mechanism of direct and observational conditioning for placebo and nocebo responses. Neuroimage. 2019;184:954-63.

Carlino E, Vase L. Can knowledge of Placebo and Nocebo Mechanisms Help Improve Randomized Clinical Trials? Int Rev Neurobiol. 2018;138:329-57.

Holmes RD, Tiwari AK, Kennedy JL. Mechanisms of the placebo effect in pain and psychiatric disorders. The Pharmacogenomics Journals. 2016;16(6):491-500.

Macias-Cortes EC, Llanes-Gonzalez L, Aguilar-Faisal L, Asbun-Bojalil J. Individualized homeopathic treatment and fluoxetine for moderate to severe depression in peri- and postmenopausal women: a randomized, double-dummy, double-blind, placebo-controlled trial. J Foot Ankle Surg. 2015;54(2):768-72.

Jensen KB, Kaptchuk TJ, Chen X. A Neural Mechanism for Nonconscious Activation of Conditioned Placebo and Nocebo Responses. Cereb Cortex. 2015;25(10):3903-10.

Quattrone A, Barbagallo G, Cerasa A, Stoessl AJ. Neurobiology of placebo effect in Parkinson's disease: What we have learned and where we are going. Mov Disord. 2018 Aug;33(8):1213-27. Doi: 10.1002/mds.27438.

Benedetti F, Arduino C, Costa S. Loss of expectation-related mechanisms in Alzheimer's disease makes analgesic therapies less effective. Pain. 2006;121(1-2):133-44.

Ningyuan Z. Quantifying placebo responses in clinical evaluation of neuropsychiatric symptoms in alzheimer´s disease. Eur J Clin Pharmacol. 2019;75(4):497-509.

Ong WY, Stohler CS, Herr DR. Role of the Prefrontal Cortex in Pain Processing. Molecular neurobiology. 2019;56(2):1137-66.

Koban L, Kross E, Woo CW, Ruzic L, Wager TD. Frontal-Brainstem Pathways Mediating Placebo Effects on Social Rejection. Stroke. 2017;48:1412-5.

Upadhyaya HP, Arnold LM, Alaka K, Qiao M, Williams D, Mehta R. Efficacy and safety of duloxetine versus placebo in adolescents with juvenile fibromyalgia: results from a randomized controlled trial. Cancer Prev Res (Phila). 2019;12(7):481-90.

Arakawa A, Kaneko M, Narukawa M. An investigation of factors contributing to higher levels of placebo response in clinical trials in neuropathic pain: a systematic review and meta-analysis. J Clin Oncol. 2015;33(5):433-41.

Winner P, Linder S, Hershey AD. Consistency of response to sumatriptan/naproxen sodium in a randomized placebo-controlled, cross-over study for the acute treatment of migraine in adolescence. Am J Psychiatry. 2015;172(9):870-80.

Testa M, Rossettini G. Enhance placebo, avoid nocebo: How contextual factors affect physiotherapy outcomes. Man Ther. 2016;24:65-74.

Rossettini G, Carlino E, Testa M. Clinical relevance of contextual factors as triggers of placebo and nocebo effects in musculoskeletal pain. BMC Musculoskelet Disord. 2018;19:27. Disponible en: https://doi.org/10.1186/s12891-018-1943-8.

Grenfell RF, Briggs AH, Holland WC. A double-blind study of the treatment of hypertension. JAMA. 1961;176:124-8.

Shiv BC, Ariely D. Placebo Effects of Marketing Actions: Consumers May Get What They Pay For. Journal of Marketing Research. 2005;XLII:383-93.

Espay AJ, Norris MM, Eliassen JC. Placebo effect of medication cost in Parkinson disease: a randomized double-blind study. Neurology. 2015;84(8): 794-802.

Kaptchuk T, Stason WB, Davis RB, Legedza AT, Schnyer RN, Kerr KE, et al. Sham device v inert pill: randomised controlled trial of two placebo treatments. BMJ. 2006 (1 February). Doi: 10.1136/bmj.38726.603310.55

Chae Y, Lee YS, Enck P. How Placebo Needles Differ From Placebo Pills? Frontiers in Psychiatry. 2018;9(243). Doi: 10.3389/fpsyt.2018.00243

Cobb LAT, Dillard DH, Merendino KA, Bruce RA. An evaluation of internal mammary artery ligation by a double-blind technic. NEJM. 1959;260:1115-8.

Dimond EG, Crockett JE. Comparison of internal mammary artery ligation and sham operation for angina pectoris. J Cardiol. 1960;5:483-9.

Al-Lamee RT, Dehbi HM, Sen S, Tang K, Davies J. Percutaneous coronary intervention in stable angina (ORBITA): a doubleblind, randomised controlled trial. Lancet. 2018;391(10115):31-40.

Moseley JB, O^Malley K, Petersen NJ, Menke TJ. A controlled trial of arthroscopic surgery for osteoarthritis of the knee. NJEM. 2002;347:81-8.

Goetz CGW, McDermott MP, Adler CH, Fahn S, Freed CR, Hauser RA, et al. Placebo response in Parkinson's disease: Comparisons among 11 trials covering medical and surgical interventions. Mov Disord. 2008;23(5):690-9.

Asif AH, Iswat S, Choudry UK, Siddiqa IA. Recent Advances in Stem Cell Therapy for Parkinson’s Disease. AJBSR. 2020;7(3):279-91.

Burke MJ, Kaptchuk TJ, Pascual-Leone A. Challenges of differential placebo effects in contemporary medicine: The example of brain stimulation. Cancer. 2019;125(7):1081-90.

Mercado RM, Kumar A, Schulzer M, Stoessl AJ, Honey CR. Expectation and the placebo effect in Parkinson`s disease patients with subthalamic nucleus deep brain stimulation. Mov Disord. 2006;21(9):1457-61.

Conforto AB, Amaro E, Gonçalves AL, Prieto J, Zukerman V, Ferreira J. Randomized, proof of-principle clinical trial of active transcranial magnetic stimulation in chronic migraine. Cephalagia. 2014;34(6):464-72.

Granato A, Fantini J, Monti F, Furlanis G, Musho S, Semenic M, et al. Dramatic placebo effect of high frequency repetitive TMS in treatment of chronic migraine and medication overuse headache. J Clin Neurosci. 2019;60:96-100.

Irwin SL, Qubty W, Allen IE, Patniyot I, Goadsby PJ, Gelfand AA. Transcranial Magnetic Stimulation for Migraine Prevention in Adolescents: A Pilot Open-Label Study. Headache. 2018;58(5):724-31.

Skierka AS, Michels KB. Ethical principles and placebo-controlled trials - interpretation and implementation of the Declaration of Helsinki's placebo paragraph in medical research. Prog Neuropsychopharmacol Biol Psychiatry. 2018;84(A):267-71.

Greene BMT, Cupp EW. Comparison of ivermectin and diethylcarbamazine in the treatment of onchocerciasis. NEJM. 1985;313:133-8.

Gandara DRH, Monaghan GG. The delayed-emesis syndrome from cisplatin: phase III evaluation of ondansetron versus placebo. Semin Oncol. 1992;19(Suppl 1):67-71.

Khanna S, Vieta E, Lyons B, Grossman F, Eerdekens M, Kramer M. Risperidone in the treatment of acute mania Double-blind, placebo-controlled study. British Journal Of Psychiatry. 2005;187:229-34.

Srinivasan S, Pai S, Bhan A, Jesani A, Thomas G. Trial of risperidone in India – concerns. British Journal of Psychiatry. 2006;188(5):489. Doi: 10.1192/bjp.188.5.489

Lam RMH. El placebo y el efecto placebo. Rev Cubana Hematol Inmunol Hemoter. 2014;30:214-22.

Rothman KJM. The Continuing Unethical Use of Placebo Controls. NEJM. 1994;331(6):394-8.





Licencia de Creative Commons
Esta obra está bajo una licencia de Creative Commons Reconocimiento-NoComercial 4.0 Internacional.