Warning about side effects can increase their occurrence: an experimental model using placebo treatment for sleep difficulty.

Patients in clinical practice and participants in clinical trials are warned about side effects that may result from their treatment. Such warnings could lead to placebo-induced side effects if they create an expectation of these effects. We used an experimental model to test this possibility. Undergraduates reporting sleep difficulty received placebo treatment disguised as a hypnotic for one week and were warned about either one or four bogus side effects. Placebo treatment significantly improved sleep difficulty relative to a no treatment control group, as indicated by self-report and by objective outcomes. At the end of the treatment week participants who had been warned about a single side effect showed better recall of this effect than those warned about four side effects. Most importantly, participants tended to report experiencing a side effect they had been warned about, with a trend towards a larger effect in participants warned about one side effect. This evidence for placebo-induced side effects may need to be considered when interpreting data on side effects from clinical trials.

RCT Entities:   Population Interventions Outcomes