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

Abstract

ObjectivesTo 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.DesignA 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).Participants30 healthy adults who took part in the randomised controlled trial.ResultsParticipants 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.ConclusionIntegrating lay perspectives into the scientific rationale of OLP treatments might enhance the plausibility and credibility of the rationale in ethical treatments.Trial registration numberNCT02578420.

“Let’s see what happens:”—Women’s experiences of open-label placebo treatment for menopausal hot flushes in a randomized controlled trial

“…The seeming paradox of an inert pill creating measurable benefits made some women more curious about whether it would work and fascinated when it did. Nonetheless, the participants were aware that the idea of effective placebos was technically absurd, especially from an outside perspective, which corroborated the findings of two other qualitative OLP studies [29,34].…”

“…Like our study, IBS patients spoke of hope, were reluctant to attribute improvement to placebo, engaged in self-reflection, and felt empowered [29]. Another qualitative study followed an experimental OLP pain trial comparing two different OLP rationales [34]. This high-quality study assessed how participants conceptualize the placebo effect, their thoughts on OLP, and underlying mechanisms concerning the rationale and their experiences.…”

“…It appears that our participants were more pragmatic than other OLP patients. Secondly, unlike the common notion of placebos being better than nothing [34,38], some women noted that placebos were perfect for hot flushes and, in that way, superior to hormone therapy. As menopause is not a disease, one should not use strong medications to "treat" the symptoms.…”

‘It's not my greengrocer, it's someone from the medical profession’: A qualitative study regarding acceptability of deceptive and open‐label placebo prescribing in France

“…Even fewer studies have compared the acceptability of DP and OLP. To the extent of our knowledge only one other study had these similar strengths (Locher et al, 2021). Few studies discussed the variety of administration of placebo interventions ranging from an inert pill to manual therapy, surgery or other nonpharmacological interventions.…”

“…Similarly, physicians sometimes consider OLP to be disrespectful to patients and at risk of offending them (Bernstein, Locher, Stewart‐Ferrer, et al, 2020). One qualitative study interviewed healthy participants to explore OLP usability but with an aim less focused on acceptability rather than on the plausibility of the treatment rationale (Locher et al, 2021). This study looked at lay people's attitudes towards OLP treatments after use focused on the rationale rather than the acceptability of the treatment (Locher et al, 2021) without informing participants of the existence of OLP treatments in the non‐OLP groups.…”