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.
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Acknowledgments
We would like to thank Professor Peter Lovibond, University of New South Wales for his useful advice along the way and Professor Robert Boakes, University of Sydney for his thoughtful comments on an earlier draft. This research was partially funded by a University of New South Wales Vice-Chancellor’s Postdoctoral Fellowship (2011–2012) awarded to Ben Colagiuri.
Conflict of interest
Both authors, Nadine Neukirch and Ben Colagiuri, declare that they have no conflict of interest.
Human and Animal Rights and Informed Consent
All procedures followed were in accordance with the ethical standards of the responsible committee on human experimentation (institutional and national) and with the Helsinki Declaration of 1975, as revised in 2000 (5). Informed consent was obtained from all patients for being included in the study.
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Neukirch, N., Colagiuri, B. The placebo effect, sleep difficulty, and side effects: a balanced placebo model. J Behav Med 38, 273–283 (2015). https://doi.org/10.1007/s10865-014-9590-5
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DOI: https://doi.org/10.1007/s10865-014-9590-5