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Gepubliceerd in:

01-04-2015

The placebo effect, sleep difficulty, and side effects: a balanced placebo model

Auteurs: Nadine Neukirch, Ben Colagiuri

Gepubliceerd in: Journal of Behavioral Medicine | Uitgave 2/2015

Abstract

Medical treatment is usually accompanied by a warning about potential side effects. While constituting an important component of informed consent, these warnings may themselves contribute to side effects via the placebo effect. We tested this possibility using a 2 × 2 between-subjects design. Under the guise of a trial of a new hypnotic, 91 undergraduates experiencing difficulty sleeping were allocated to receive a warning about a target side effect (either increase or decrease in appetite, counterbalanced) or no warning and then to receive placebo treatment or no treatment for one week. Placebo treatment led to significantly better sleep on almost all self-reported outcomes, suggesting a placebo effect for reported sleep difficulty. Actigraphy recordings were unaffected by treatment. There was a clear effect of the warning in that placebo treated participants who were warned about side effects were much more likely to report the target side effect than those not warned about side effects. Implications for clinical practice are discussed.

vorige artikel The effect of a supplementary (‘gist-based’) information leaflet on colorectal cancer knowledge and screening intention: a randomized controlled trial

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Amanzio, M., & Benedetti, F. (1999). Neuropharmacological dissection of placebo analgesia: Expectation-activated opioid systems versus conditioning-activated specific subsystems. Journal of Neuroscience, 19, 484–494.PubMed

Amanzio, M., Benedetti, F., & Vase, L. (2012). A systematic review of adverse events in the placebo arm of donepezil trials: The role of cognitive impairment. International Psychogeriatrics, 24, 698–707.CrossRefPubMed

Amanzio, M., Corazzini, L. L., Vase, L., & Benedetti, F. (2009). A systematic review of adverse events in placebo groups of anti-migraine clinical trials. Pain, 146, 261–269.CrossRefPubMed

Barsky, A. J., Saintfort, R., Rogers, M. P., & Borus, J. F. (2002). Nonspecific medication side effects and the nocebo phenomenon. Journal of the American Medical Association, 287, 622–627.CrossRefPubMed

Bastien, C. H., Vallieres, A., & Morin, C. M. (2001). Validation of the Insomnia Severity Index as an outcome measure for insomnia research. Sleep Medicine, 2, 297–307.CrossRefPubMed

Benedetti, F., Amanzio, M., Vighetti, S., & Asteggiano, G. (2006). The biochemical and neuroendocrine bases of the hyperalgesic nocebo effect. Journal of Neuroscience, 26, 12014–12022.CrossRefPubMed

Buysse, D. J., Reynolds, C. F., Monk, T. H., Berman, S. R., & Kupfer, D. J. (1989). The Pittsburgh Sleep Quality Index: A new instrument for psychiatric practice and research. Psychiatry Research, 28, 193–213.CrossRefPubMed

Carpenter, J. S., & Andrykowski, M. A. (1998). Psychometric evaluation of the Pittsburgh Sleep Quality Index. Journal of Psychosomatic Research, 45, 5–13.CrossRefPubMed

Colagiuri, B., Dhillon, H., Butow, P., Jansen, J., Cox, K., & Jacquet, J. (2013). Does assessing patients’ expectancies about chemotherapy side effects influence their occurrence? Journal of Pain and Symptom Management, 46, 275–281.

Colagiuri, B., McGuinness, K., Boakes, R. A., & Butow, P. N. (2012). Warning about side effects can increase their occurrence: An experimental model using placebo treatment for sleep difficulty. Journal of Psychopharmacology, 26, 1547.CrossRef

Colagiuri, B., Roscoe, J. A., Morrow, G. R., Atkins, J. N., Giguere, J. K., & Colman, L. K. (2008). How do patient expectancies, quality of life, and postchemotherapy nausea interrelate? Cancer, 113, 654–661.CrossRefPubMedCentralPubMed

Colagiuri, B., & Zachariae, R. (2010). Patient expectancy and post-chemotherapy nausea: A meta-anlaysis. Annals of Behavioral Medicine, 40, 14.CrossRef

Draganich, C., & Erdal, K. (2014). Placebo sleep affects cognitive functioning. Journal of Experimental Psychology. Learning, Memory, and Cognition, 40, 857–864. doi:10.1037/a0035546 CrossRefPubMed

Finniss, D. G., Kaptchuk, T. J., Miller, F., & Benedetti, F. (2010). Biological, clinical, and ethical advances of placebo effects. Lancet, 375, 686–695.CrossRefPubMedCentralPubMed

Flaten, M. A., Simonsen, T., & Olsen, H. (1999). Drug-related information generates placebo and nocebo responses that modify the drug response. Psychosomatic Medicine, 61, 250–255.CrossRefPubMed

Fratello, F., Curcio, G., Ferrara, M., Marzano, C., Couyoumdjian, A., Petrillo, G., et al. (2005). Can an inert sleeping pill affect sleep? Effects on polysomnographic, behavioral and subjective measures. Psychopharmacology (Berl), 181, 761–770.CrossRef

Gibbs, S., Waters, W. E., & George, C. F. (1989). The benefits of prescription information leaflets (2). British Journal of Clinical Pharmacology, 28, 345–351.CrossRefPubMedCentralPubMed

Howland, J. S., Baker, M. G., & Poe, T. (1990). Does patient education cause side effects? A controlled trial. Journal of Family Practice, 31, 62–64.PubMed

Hyland, M. E. (2011a). Motivation and placebos: Do different mechanisms occur in different contexts? Philosophical Transactions of the Royal Society B: Biological Sciences, 366, 1828–1837. doi:10.1098/rstb.2010.0391 CrossRef

Hyland, M. E. (2011b). The origins of health and disease. Cambridge: Cambridge University Press.CrossRef

Jewett, D. L., Fein, G., & Greenberg, M. H. (1990). A double-blind study of symptom provocation to determine food sensitivity. New England Journal of Medicine, 323, 429–433.CrossRefPubMed

Kaptchuk, T. J., Stason, W. B., Davis, R. B., Legedza, A. R., Schnyer, R. N., Kerr, C. E., et al. (2006). Sham device v inert pill: Randomised controlled trial of two placebo treatments. British Medical Journal, 332, 391–397.CrossRefPubMedCentralPubMed

Kirsch, I. (1997). Response expectancy theory and application: A decennial review. Applied and Preventive Psychology, 6, 69–79.CrossRef

Kong, J., Gollub, R. L., Polich, G., Kirsch, I., Laviolette, P., Vangel, M., et al. (2008). A functional magnetic resonance imaging study on the neural mechanisms of hyperalgesic nocebo effect. Journal of Neuroscience, 28, 13354–13362.CrossRefPubMedCentralPubMed

Link, J., Haggard, R., Kelly, K., & Forrer, D. (2006). Placebo/nocebo symptom reporting in a sham herbal supplement trial. Evaluation and the Health Professions, 29, 394–406.CrossRefPubMed

Littner, M., Kushida, C. A., Anderson, W. M., Bailey, D., Berry, R. B., Davila, D. G., et al. (2003). Practice parameters for the role of actigraphy in the study of sleep and circadian rhythms: An update for 2002. Sleep, 26, 337–341.PubMed

McFadden, E. R, Jr, Luparello, T., Lyons, H. A., & Bleecker, E. (1969). The mechanism of action of suggestion in the induction of acute asthma attacks. Psychosomatic Medicine, 31, 134–143.CrossRefPubMed

Mondaini, N., Gontero, P., Giubilei, G., Lombardi, G., Cai, T., Gavazzi, A., et al. (2007). Finasteride 5 mg and sexual side effects: How many of these are related to a Nocebo phenomenon? Journal of Sexual Medicine, 4, 1708–1712.CrossRefPubMed

Morin, C. M. (1993). Insomnia: Psychological assessment and management. New York: Guilford Press.

Myers, M. G., Cairns, J. A., & Singer, J. (1987). The consent form as a possible cause of side effects. Clinical Pharmacology and Therapeutics, 42, 250–253.CrossRefPubMed

Nestoriuc, Y., Orav, E. J., Liang, M. H., Horne, R., & Barsky, A. J. (2010). Prediction of nonspecific side effects in rheumatoid arthritis patients by beliefs about medicines. Arthritis Care & Research, 62, 791–799.CrossRef

Rief, W., Barsky, A. J., Glombiewski, J. A., Nestoriuc, Y., Glaesmer, H., & Braehler, E. (2011). Assessing general side effects in clinical trials: Reference data from the general population. Pharmacoepidemiology and Drug Safety, 20, 405–415.CrossRefPubMed

Roscoe, J. A., Morrow, G. R., Colagiuri, B., Heckler, C. E., Pudlo, B. D., Colman, L., et al. (2010). Insight in the prediction of chemotherapy-induced nausea. Supportive Care in Cancer, 18, 869–876.CrossRefPubMedCentralPubMed

Sadeh, A. (2011). The role and validity of actigraphy in sleep medicine: An update. Sleep Medicine Reviews, 15, 259–267. doi:10.1016/j.smrv.2010.10.001 CrossRefPubMed

Schweiger, A., & Parducci, A. (1981). Nocebo: The psychologic induction of pain. Pavlovian Journal of Biological Science, 16, 140–143.PubMed

Shelke, A. R., Roscoe, J. A., Morrow, G. R., Colman, L. K., Banerjee, T. K., & Kirshner, J. J. (2008). Effect of a nausea expectancy manipulation on chemotherapy-induced nausea: A University of Rochester Cancer Center Community Clinical Oncology Program study. Journal of Pain and Symptom Management, 35, 381–387.CrossRefPubMedCentralPubMed

Silvestri, A., Galetta, P., Cerquetani, E., Marazzi, G., Patrizi, R., Fini, M., et al. (2003). Report of erectile dysfunction after therapy with beta-blockers is related to patient knowledge of side effects and is reversed by placebo. European Heart Journal, 24, 1928–1932.CrossRefPubMed

Sohl, S. J., Schnur, J. B., & Montgomery, G. H. (2009). A meta-analysis of the relationship between response expectancies and cancer treatment-related side effects. Journal of Pain and Symptom Management, 38, 775–784.CrossRefPubMedCentralPubMed

Stewart-Williams, S. (2004). The placebo puzzle: Putting together the pieces. Health Psychology, 23, 198–206.CrossRefPubMed

Suetsugi, M., Mizuki, Y., Yamamoto, K., Uchida, S., & Watanabe, Y. (2007). The effect of placebo administration on the first-night effect in healthy young volunteers. Progress in Neuro-Psychopharmacology and Biological Psychiatry, 31, 839–847.CrossRefPubMed

Vallières, A., & Morin, C. M. (2003). Actigraphy in the assessment of insomnia. Sleep, 26, 902–906.PubMed

Varelmann, D., Pancaro, C., Cappiello, E. C., & Camann, W. R. (2010). Nocebo-induced hyperalgesia during local anesthetic injection. Anesthesia and Analgesia, 110, 868–870.CrossRefPubMed

Walsh, J. K., Roth, T., Randazzo, A., Erman, M., Jamieson, A., Scharf, M., et al. (2000). Eight weeks of non-nightly use of zolpidem for primary insomnia. Sleep, 23, 1087–1096.PubMed

Weihrauch, T. R., & Gauler, T. C. (1999). Placebo-efficacy and adverse effects in controlled clinical trials. Arzneimittel-Forschung, 49, 385–393.PubMed

Titel: The placebo effect, sleep difficulty, and side effects: a balanced placebo model
Auteurs: Nadine Neukirch
Ben Colagiuri
Publicatiedatum: 01-04-2015
Uitgeverij: Springer US
Gepubliceerd in: Journal of Behavioral Medicine / Uitgave 2/2015
Print ISSN: 0160-7715
Elektronisch ISSN: 1573-3521
DOI: https://doi.org/10.1007/s10865-014-9590-5

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