Debriefing to placebo allocation: A phenomenological study of participants’ experiences in a randomized clinical trial. Conference paper presented at ECIM 2010.

Question: Concealment is integral to placebo-controlled clinical trials and insures that participants remain blind to whether they are receiving real (verum) or dummy (placebo) treatment. While participants are routinely informed about and consent to be randomised to verum or placebo, they are typically never told which treatment they actually received: they are not debriefed to treatment allocation. Participants’ experiences of this aspect of trials have not been well-described.Methods: We therefore conducted an idiographic phenomenological study of four participants’ experiences of being blinded to and then debriefed to placebo allocation in a placebo-controlled clinical trial (conducted in the USA). Four participants in a trial of acupuncture for IBS were interviewed before, during, and after receiving a course of placebo treatments over 6 weeks. During the final interview they were debriefed to placebo allocation.Results: Each participant's experiences of being blinded to and then debriefed to placebo allocation are described in depth using a phenomenological approach based on the Sheffield School. All four thought they had received real acupuncture, and based their belief on a combination of embodied experiences during and after treatments, and their perceptions of their acupuncturists. They were all surprised to be told they had placebo, and did not unquestionably accept this news. Instead, they developed revised explanations that reconciled their lived experiences (of real acupuncture) with the conflicting news (of placebo acupuncture) from the interviewer.Conclusions: Our participants’ experiences of blinding and debriefing were embodied, related to their goals in undertaking the study, and social – embedded in trusting and valued relationships with acupuncturists, told to others outside the study, and described to an interviewer. This work suggests that debriefing to placebo allocation can and should be managed sensitively to facilitate positive outcomes for participants: further research should focus on developing best practice in this area.