Lay perspectives of the open-label placebo rationale: a qualitative study of participants in an experimental trial.

ABSTRACT

OBJECTIVES: To analyse participants' concepts about the open-label placebo (OLP) effect; to explore their views about the discussion points that are applied in conventional OLP trials and to examine their experiences of taking part in an OLP trial. DESIGN: A qualitative study using thematic analysis of semistructured interviews that were nested within a randomised controlled trial investigating experimental OLP analgesia (registered at ClinicalTrials.gov NCT02578420). PARTICIPANTS: 30 healthy adults who took part in the randomised controlled trial. RESULTS: Participants mostly conceptualised placebo as something that is inert and requires deception in order to be effective. Interviewees used a broad definition of placebos, going beyond a conventional notion of sugar pills. In contrast to the conventional OLP rationale, participants seldom emphasised classical conditioning as a mechanism of placebo effects, stressing a variety of other well-established components through which placebos might be therapeutic, whereas the conventional OLP disclosures state that 'a positive attitude helps but is not necessary', participants in our study applied other attitudes, such as 'it's worth a try'. When asked about their experiences during the trial, the majority emphasised that the concept of OLP was completely novel to them. Participants were rather sceptical about the efficacy of the intervention. CONCLUSION: Integrating lay perspectives into the scientific rationale of OLP treatments might enhance the plausibility and credibility of the rationale in ethical treatments. TRIAL REGISTRATION NUMBER NCT02578420.