Efecto placebo en la enfermedad inflamatoria intestinal

Article information

Resumen

Desde tiempo inmemorial se han empleado placebos para el tratamiento de pacientes con muy distintas enfermedades. Recientemente, se ha renovado el interés en dichas sustancias, dado que la utilización del ensayo clínico controlado con placebo se ha convertido en la herramienta más útil para comprobar la eficacia de un fármaco en pacientes con una enfermedad determinada. En el caso de la enfermedad inflamatoria intestinal (EII), tanto en la enfermedad de Crohn como en la colitis ulcerosa, se ha observado cómo los pacientes del brazo placebo de los ensayos clínicos obtienen unos resultados muy significativos, superando incluso a los que se consiguen con agentes farmacológicos en otros estudios. Los pacientes con EII tienen algunas características que les hacen especialmente proclives a la aparición del efecto placebo: son enfermedades crónicas que cursan en brotes, y el dolor es uno de los síntomas cardinales. En el futuro será fundamental cuantificar adecuadamente el efecto placebo en los diferentes escenarios clínicos de la EII, para poder diseñar ensayos clínicos que puedan demostrar la verdadera eficacia de los tratamientos investigados.

Palabras clave:

Enfermedad inflamatoria intestinal

Placebo

Colitis ulcerosa

Enfermedad de Crohn

Abstract

Since time immemorial, placebos have been used in the treatment of patients with very different diseases. Interest in these substances has recently been renewed, since the use of placebo-controlled clinical trials has become the most useful tool to demonstrate the efficacy of a particular drug in patients with specific diseases. In inflammatory bowel disease (IBD), both in Crohn's disease and in ulcerative colitis, highly significant results have been obtained in patients in the placebo arm of clinical trials, surpassing even those achieved with drugs in other studies. Patients with IBD show certain characteristics that make them especially susceptible to the placebo effect: IBD are chronic diseases occurring in flares and pain is one of the main symptoms. In future, the placebo effect should be adequately quantified in the distinct clinical scenarios of IBD in order to design clinical trials that could demonstrate the true efficacy of the treatments investigated.

Key words:

Inflammatory bowel disease

Placebo

Ulcerative colitis

Crohn's disease

Full text is only aviable in PDF

Bibliografía

[1.]

Platón.

Diálogos.

1.ª ed., Gredos, (2008),

[2.]

Diccionario de la Lengua Española.

Real Academia Española.

22.ª ed., Espasa-Calpe, (2001),

[3.]

P.C. Gøtzsche.

Is there a logic in the placebo?.

The Lancet, 344 (1994), pp. 925-926

[4.]

G.A. Hoffman, A. Harrington, H.L. Fields.

Pain and the placebo.

Perspect Biol Med, 48 (2005), pp. 248-265

http://dx.doi.org/10.1353/pbm.2005.0054 | Medline

[5.]

W.P. Kennedy.

The nocebo reaction.

Med World, 95 (1961), pp. 203-205

Medline

[6.]

E. Ernst, K.L. Resch.

Concept of true and perceived placebo effects.

BMJ, 311 (1995), pp. 551-553

Medline

[7.]

A. Aratari, C. Papi, B. Galletti, E. Angelucci, A. Viscido, V. D’Ovidio, et al.

Seasonal variations in onset of symptoms in Crohn's disease.

Dig Liver Dis, 38 (2006), pp. 319-323

http://dx.doi.org/10.1016/j.dld.2005.10.002 | Medline

[8.]

J.D. Lewis, F.N. Aberra, G.R. Lichtenstein, W.B. Bilker, C. Bresinger, B.L. Strom.

Seasonal variations in flares of inflammatory bowel disease.

Gastroenterology, 126 (2004), pp. 665-673

Medline

[9.]

T.J. Kaptchuk.

The placebo effect in alternative medicine: can the performance of a healing ritual have clinical significance?.

Ann Intern Med, 136 (2002), pp. 817-825

Medline

[10.]

P. Petrovic, E. Kalso, K.M. Petersson, M. Ingvar.

Placebo and opioid analgesia: Imaging a shared neuronal network.

Science, 295 (2002), pp. 1737-1740

http://dx.doi.org/10.1126/science.1067176 | Medline

[11.]

C.N. Bernstein.

The placebo effect for gastroenterology: tool or torment.

Clin Gastroenterol Hepatol, 4 (2006), pp. 1302-1308

[12.]

R.A. Sternbach.

The effects of instructional sets on autonomic responsivity.

Psychophysiology, 62 (1962), pp. 67-72

[13.]

The Coronary Drug Project Research Group.

Influence of adherence to treatment and response of cholesterol on mortality in the coronary drug project.

N Engl J Med, 303 (1980), pp. 1038-1041

[14.]

M.T. Kluger, H. Owen.

Patient controlled analgesia: can it be made safer?.

Anesthesia Intensive Care, 19 (1991), pp. 412-420

[15.]

Z. Di Blasi, E. Harkness, E. Ernst, A. Georgiou, J. Kleijnen.

Influence of context effects on health outcomes: a systematic review.

Lancet, 357 (2001), pp. 757-762

Medline

[16.]

R. Crow, H. Gage, S. Hampson, J. Hart, A. Kimber, H. Thomas.

The role of expectancies in the placebo effect and their use in the delivery of health care: a systematic review.

Health Technol Asses, 3 (1999), pp. 1-96

[17.]

T.J. Kaptchuk, J.M. Kelley, L.A. Conboy, R.B. Davis, C.E. Kerr, E.E. Jacobson, et al.

Components of placebo effect: randomized controlled trial in patients with irritable bowel syndrome.

BMJ, 336 (2008), pp. 999-1003

http://dx.doi.org/10.1136/bmj.39524.439618.25 | Medline

[18.]

H.C. Sox, I. Margulies, C.H. Sox.

Psychologically mediated effects of diagnostic tests.

Ann Intern Med, 95 (1981), pp. 680-685

Medline

[19.]

A. Ilnyckyi, F. Shanahan, P.A. Anton.

Quantification of the placebo response in ulcerative colitis.

Gastroenterology, 112 (1997), pp. 1854-1858

Medline

[20.]

C. Su, J.D. Lewis, B. Goldberg, C. Brensinger, G.R. Lichtenstein.

A meta-analysis of the placebo rates of remission and response in clinical trials of active ulcerative colitis.

Gastroenterology, 132 (2007), pp. 516-526

http://dx.doi.org/10.1053/j.gastro.2006.12.037 | Medline

[21.]

C. Su, G.R. Lichtenstein, K. Krok, C. Brensinger, J.D. Lewis.

A metaanalysis of the placebo rates of remission and response in clinical trials of active Crohn's disease.

Gastroenterology, 126 (2004), pp. 1257-1269

Medline

[22.]

R.H. Franke, J.D. Kaul.

The Hawthorne experiments: first statistical interpretation.

Am Sociol Rev, 43 (1978), pp. 623-643

[23.]

F.G. Miller, T.J. Kaptchuk.

The power of context: reconceptualizing the placebo effect.

J R Soc Med, 101 (2008), pp. 222-225

http://dx.doi.org/10.1258/jrsm.2008.070466 | Medline

[24.]

A. Hróbjartsson.

What are the main methodological problems in the estimation of placebo effects?.

J Clin Epidemiol, 55 (2002), pp. 430-435

Medline

[25.]

M. Pitz, M. Cheang, C.N. Bernstein.

Defining the predictors of the placebo response in irritable bowel syndrome.

Clin Gastroenterol Hepatol, 3 (2005), pp. 237-247

Medline

[26.]

A.JM. De Craen, D.E. Moerman, S.H. Heisterkamp, G.N. Tytgat, J.G. Tijssen, J. Kleijnen.

Placebo effect in the treatment of duodenal ulcer.

Br J Clin Pharmacol, 48 (1999), pp. 853-860

Medline

[27.]

B. Blackwell, S. Bloomfield, C.R. Buncher.

Demonstration to medical students of placebo responses and non-drug factors.

Lancet, I (1972), pp. 1279-1282

[28.]

R.L. Waber, B. Shiv, Z. Carmon, D. Ariely.

Comercial features of placebo and therapeutic efficacy.

JAMA, 299 (2008), pp. 1016-1017

[29.]

P. Nos.

¿Cómo integrar en la evidencia los resultados con placebo?.

EII al día, 5 (2006), pp. 55-57

[30.]

S. Renna, C. Cammà, I. Modesto, G. Cabibbo, D. Scimeca, G. Civitavecchia, et al.

Meta-analysis of the placebo rates of clinical relapse and severe endoscopic recurrence in postoperative Crohn's disease.

Gastroenterology, 135 (2008), pp. 1500-1509

http://dx.doi.org/10.1053/j.gastro.2008.07.066 | Medline

[31.]

Loftus EV Jr, Wu EQ, Johnson S, Chao J, Mulani P. Remission in biologic-eligible patients with Crohn's disease treated with placebo (P0776). United European Gastroenterology Week. Viena, octubre, 2008,

[32.]

S. Garud, A. Brown, A. Cheifetz, E.B. Levitan, C.P. Kelly.

Meta-analysis of the placebo response in ulcerative colitis.

Dig Dis Sci, 53 (2008), pp. 875-891

http://dx.doi.org/10.1007/s10620-007-9954-6 | Medline

[33.]

P. Lichtenberg, U. Heresco-Levy, U. Nitzan.

The ethics of the placebo in clinical practice.

J Med Ethics, 30 (2004), pp. 551-554

[34.]

R. Pittrof, I. Rubinstein.

The thinkings doctor's guide to placebos.