All four participants thought they had received real acupuncture and were surprised to be told they had placebo. Being debriefed to placebo allocation directly contradicted participants’ embodied and social experiences in the trial and thus meant that someone was mistaken: either the interviewer was mistaken and the participant had indeed received real acupuncture or the participant had misinterpreted their own experiences in the trial and had actually received placebo acupuncture. Frances refused to believe that she had received placebo acupuncture because she was sure the needles had pierced her skin. Alan interpreted his placebo responding as indicating that psychological features such as stress and emotions are very important contributors to IBS. David linked his placebo responding to the emotional support he valued during treatment. Ben integrated his placebo responding into a positive self-identity capable of healing, but was concerned that he might have thrown the trial by benefiting from placebo. These four participants’ experiences each have unique features and the particular setting (an acupuncture trial) must be remembered. However, our analysis has produced some insights which bring to mind existing literature and suggest avenues for future research and research practice.
We found little direct evidence in these interviews of unresolved psychological distress on debriefing to placebo. However, our participants had all thought they were receiving real acupuncture and so being debriefed to placebo had the potential to be distressing and participants did develop revised explanations that reconciled their lived experience (of real acupuncture) with the conflicting news (of placebo acupuncture) from the interviewer. This reconciliation was linked to participants’ reasons for being in the trial (their projects). Alan, David, and Ben all focused on their IBS rather than on acupuncture. They also believed, to varying degrees, that they could benefit from a placebo treatment. Their primary goals could thus be achieved regardless of treatment allocation. Ben and David also looked to the future and decided to have the real acupuncture treatments provided by the study, thus maintaining their additional goal to try acupuncture. Frances resisted revising her embodied experiences in the trial and instead denied the contradicting “fact” that she had consistently received placebo. In this way, her primary project was maintained; by taking part in the trial she had tried acupuncture. Future studies should explore the relationship between project and reaction to placebo debriefing. Perhaps the tensions inherent in placebo debriefing could be eased by encouraging trial participants to have goals that relate to their illness or to the production of knowledge instead of the specific treatment being tested.
The embodied experience of our participants was that they had received real acupuncture. They felt the needles pierce their skin and experienced benefit from their treatments. The act of treatment was particularly salient to our participants and their proprioception that the needles entered their bodies was absolutely contradicted by the abstract fact imparted by the interviewer that placebo needles do not pierce the skin. Some participants maintained that the needles had pierced their skin, and such claims were not directly challenged by the interviewer. This is consistent with the observation from discursive psychology that descriptions of invisible subjective phenomena are generally resistant to challenge (Potter, 1996
). Similarly, at debriefing participants rarely reconsidered whether or not they had received benefits from the trial. Instead, they reattributed these benefits to aspects of treatment that were not seen as exclusive to real acupuncture (e.g., emotional support, relaxation). This reattribution appeared to be facilitated by participants’ understandings of IBS: Alan, Ben, and David understood IBS as involving the mind and/or emotions in some way and were able to make sense of their placebo-responding by interpreting their symptomatic improvements as occurring through psychological means.
Patients commonly attribute IBS to psychological factors, such as anxiety and stress, but also attribute it to physical illness (Lacy et al., 2007
; Riedl et al., 2009
). Attributing IBS to psychological factors has been associated with diminished mental but enhanced physical quality of life (Riedl et al., 2009
) and with increased anxiety and depression (in cross-sectional but not longitudinal analyses, Rutter & Rutter, 2007
; Rutter & Rutter, 2002
). The common sense model of illness representations suggests that patients seek treatments that they believe to be consistent with their understandings of their illness (Leventhal, Brissette, & Leventhal, 2003
). Our findings show that both attributing one’s condition at least partly to psychological factors and also understanding placebo as a psychological treatment can allow trial participants to make sense of benefitting from placebos. Researchers could consider how to help participants to develop positive interpretations of placebo responding in other contexts. Our participants valued positive explanations of placebo-responding in terms of self-healing. Different explanations might better suit participants in studies of conventional interventions or those who attribute their symptoms to physical factors. One option would be to inform participants at the start of the trial about the possible effects and mechanisms of action of the placebo. However, the consequences of such a strategy should be investigated because increasing the credibility of the placebo condition might also increase its effects, thus making it harder for researchers to detect small treatment effects.
Our participants’ experiences of blinding and debriefing were social, in that they were embedded in trusting and valued relationships with acupuncturists, told to others outside the study, and described to an interviewer. Participants worked to maintain positive evaluations of their acupuncturists despite having been given placebo by them. This seemed easier when participants understood that the acupuncturists themselves did not allocate treatments. Seeing the acupuncturists as caring therapists working within constraints imposed by the researchers might have allowed participants to maintain a relationship with an acupuncturist who delivered placebo treatments. This need to retain a view of acupuncturists as supportive health care practitioners might be particularly strong in people with IBS (Håkanson, Sahlberg-Blom, & Ternestedt, 2010
), but is unlikely to be unique to this population. Having a clear separation of duties within a trial team and communicating this to participants might enable participants to attribute therapeutic motivations to therapists and still understand the primary purpose of the study to be the production of generalizable knowledge (Appelbaum, Roth, Lidz, Benson, & Winslade, 1987
By the time they were debriefed to placebo, participants had described to the same interviewer at least once before their experiences of treatment and their beliefs about allocation. This appears to have been partly supportive, offering an opportunity to work through concerns and consider the meanings of debriefing with a trusted member of the research team. However, it also appears to have presented additional challenges around maintaining claim to a positive social image (face - Goffman, 1967
) that might have been less problematic if the debriefing had been carried out by someone else. Directly contradicting an interviewee’s account was potentially face-threatening for both parties, because it suggested that one account was in some way wrong and the other was correct. It suggested that the participants had been deceived by the investigators (as intended) into believing that they had received real acupuncture. Tactful, supportive, facework was undertaken by the interviewer and participants to avoid conflict by reinterpreting “facts” and renegotiating accounts. This was vividly apparent in Frances’s debriefing interview when an alternative account was worked up which allowed both parties to be (partially) correct and thus maintain face. Facework has been examined in clinical interviews (e.g., Bylund et al., 2007
; Pollock, 2007
); future studies should identify strategies to manage the face-threatening aspects of debriefing interviews. It could be that debriefing participants by letter helps to attenuate the face-threatening nature of this process. However, such methods probably have their own drawbacks (e.g., no opportunity to discuss the implications of treatment allocation with a member of the research team) and so should be studied in their own right.
We would like to acknowledge some limitations of this study. We were unable to interview our participants again some time after their debriefing. Future studies should do this, to explore the nature and extent of any long term sense-making. It is unfortunate that we were unable to select our participants from a wider pool of people who had experienced debriefing to placebo. However, our aim was the description of the particular rather than the production of general “knowledge” and we have systematically engaged with our participants’ accounts to produce detailed phenomenological descriptions. To our knowledge, no such descriptions have been reported previously. The parent trial was single blind and the reactions of participants to debriefing might have been partially dependent on active collusion by the researcher to conceal allocation (Miller & Kaptchuk, 2004
). Patients made bonds with our practitioners and could have easily felt a sense of additional betrayal that might not happen in double blind research where treatment allocation is concealed from both researcher and participant. Given our participants’ emphasis on the sensations felt during treatment, it would be interesting to explore how (or even if) participants derive guesses of treatment allocation in studies of other treatments, where the treatment itself is less salient (e.g., pharmaceutical pills).
We have presented a rich description of four participants’ immediate experiences of being blinded and debriefed to placebo in an acupuncture clinical trial, which suggests some implications for the practice of research. When recruiting volunteers to a placebo-controlled trial, researchers could consider exploring participants’ reasons for taking part given that they might be allocated to a placebo treatment. When informing participants about trial treatments, researchers could consider communicating the possible effects and mechanisms of action of the placebo in a way that makes sense to the individual participant and links with their illness beliefs. When telling a participant they have responded to a placebo, researchers should be sensitive to the face-threatening nature of this conversation. Our work suggests that debriefing to placebo allocation can be managed sensitively to facilitate positive outcomes for participants and that this requires thought not only at the debriefing stage but also when recruiting participants and obtaining informed consent. We acknowledge that routinely debriefing participants to treatment allocation will inevitably place extra demands on the limited resources of those running clinical trials. Additional work is needed to explore the long term costs and benefits of different methods to debrief participants and to develop best practice in this area.