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Patients in the placebo arms of randomized controlled trials (RCT) often experience positive changes from baseline. While multiple theories concerning such “placebo effects” exist, peculiarly, none has been informed by actual interviews of patients undergoing placebo treatment. Here, we report on a qualitative study (n = 27) embedded within a RCT (n = 262) in patients with irritable bowel syndrome. Besides identical placebo acupuncture treatment in the RCT, the qualitative study patients also received an additional set of interviews at the beginning, midpoint, and end of the trial. Interviews of the 12 qualitative subjects who underwent and completed placebo treatment were transcribed. We found that patients (1) were persistently concerned with whether they were receiving placebo or genuine treatment; (2) almost never endorsed “expectation” of improvement but spoke of “hope” instead and frequently reported despair; (3) almost all reported improvement ranging from dramatic psychosocial changes to unambiguous, progressive symptom improvement to tentative impressions of benefit; and (4) often worried whether their improvement was due to normal fluctuations or placebo effects. The placebo treatment was a problematic perturbation that provided an opportunity to reconstruct the experiences of the fluctuations of their illness and how it disrupted their everyday life. Immersion in this RCT was a co-mingling of enactment, embodiment and interpretation involving ritual performance and evocative symbols, shifts in bodily sensations, symptoms, mood, daily life behaviors, and social interactions, all accompanied by self-scrutiny and re-appraisal. The placebo effect involved a spectrum of factors and any single theory of placebo—e.g. expectancy, hope, conditioning, anxiety reduction, report bias, symbolic work, narrative and embodiment—provides an inadequate model to explain its salubrious benefits.
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Introduction: Acupuncture is a complex holistic intervention in which patient–practitioner relationships and healing changes occur in interactive, iterative ways. Qualitative research is one way to capture such complexity. This study sought to understand better the experiences of adolescents involved in acupuncture treatment. Materials and methods: We included a qualitative substudy as part of a pilot randomized sham-controlled study of the use of Japanese acupuncture to treat chronic pelvic pain in adolescent girls. Seven (7) interviews were attained. Themes were double-coded and analyzed using qualitative analysis software. Results: Regardless of treatment arm, all subjects reported positive study-related changes, often attributed to positive qualities of the patient–practitioner relationship. Participants in both the sham and verum acupuncture treatment arms reported in the narratives that they were unsure of their study assignment. In contrast, the study's close-ended success of blinding question suggests that some participants were sure of their treatment allocation. Conclusions: As we continue to study acupuncture using sham controls, we need a better understanding of the possible affects of sham treatments on both treatment outcomes and success of blinding. Qualitative research is one-way to explore subtle emergent changes in participants' experiences.
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