‘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

Abstract

Objectives: To explore participants' views regarding clinical use of deceptive placebo (DP) and open-label placebo (OLP) treatments. Design: Qualitative thematic analysis. Methods: We conducted eight semi-structured interviews with healthy participants in an experimental trial comparing the efficacy of OLP and DP (Clinical trials n°NCT03934138).Interviewees' opinions were solicited following administration of placebos during the trial. Interviews were analysed using data-driven analysis. Results: We identified three themes. First, participants considered trust central in judging a placebo treatment to be acceptable. They expressed the importance of an implicit trust both in their health care professionals' (HCPs') competency as well as in the profession at large. A second theme was the perception of how placebo treatments might solve health problems. Acceptability of both types of placebo treatments was dependent on the perception patients had about the treatment solving their problem and/or doubts regarding the effectiveness of placebos The third theme encompassed perceived risks associated with placebo prescribing. Some

If only they knew! A non‐inferiority randomized controlled trial comparing deceptive and open‐label placebo in healthy individuals

“…However, looking at how OLPs should best be administered is still to be determined. For example, in our nested qualitative study (Druart et al., 2023), participants suggested the following conditions to administer OLPs in the clinical setting: a convincing rationale, time to discuss this treatment option with their healthcare provider, proven effectiveness compared to DP, appropriateness regarding the clinical situation and being included in the decision to take an OLP.…”

“…This is made apparent in the flowchart in Figure 1. At the end of the study, some participants were also invited to participate in a qualitative study regarding the acceptability of placebo treatments (Druart et al., 2023).…”

“…Furukawa et al (2014) suggest considering some no-treatment conditions such as waiting lists as nocebo effects and thus poor tools to distinguish the placebo effect from the placebo response (Furukawa et al, 2014). Finally, further research is needed to explore the acceptability of placebos, including OLPs, among patients (Blease, 2019;Druart et al, 2023).…”

“…Two recent meta-analyses showed a moderate effect size when compared to no treatment (Charlesworth et al, 2017;von Wernsdorff et al, 2021): more precisely, the most recent meta-analysis of the two, found an effect size of 0.79 with a 95% compatibility interval (95% CI) of 0.38 to 1.20 (we choose here to use the term compatibility interval instead of confidence intervals as suggested by Rafi & Greenland (2020)). However, although OLPs have a supposed ethical advantage over DPs, some patients consider effectiveness over autonomy when deciding whether a placebo treatment is acceptable or when choosing their preferred placebo administration (Bishop et al, 2014;Druart et al, 2023). As pointed out by Charlesworth et al (2017): "it is often suggested that OLP are likely to be less effective than placebos delivered deceptively".…”

Time to reflect on open-label placebos and their value for clinical practice

“…25 We are not aware of any OLP studies that have systematically engaged patients as co-producers of research in this way. Although some studies have interviewed self-selected research participants who are open-minded to OLP based on their interest in joining such a study, 11,24 the real patient perspective has yet to be properly engaged. Testimonies from individuals (such as a coauthor of this article) suggest that OLPs may not be acceptable to some patients (Fig.…”