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- Implications of placebo and nocebo effects for clinical practice: Expert consensusPublication . Evers, Andrea W. M.; Colloca, Luana; Blease, Charlotte; Annoni, Marco; Atlas, Lauren Y.; Benedetti, Fabrizio; Bingel, Ulrike; Buchel, Christian; Carvalho, Cláudia Maria Constante Ferreira de; Colagiuri, Ben; Crum, Alia J.; Enck, Paul; Gaab, Jens; Geers, Andrew L.; Howick, Jeremy; Jensen, Karin B.; Kirsch, Irving; Meissner, Karin; Napadow, Vitaly; Peerdeman, Kaya J.; Raz, Amir; Rief, Winfried; Vase, Lene; Wager, Tor D.; Wampold, Bruce E.; Weimer, Katja; Wiech, Katja; Kaptchuk, Ted J.; Klinger, Regine; Kelley, John M.Placebo and nocebo effects occur in clinical or laboratory medical contexts after administration of an inert treatment or as part of active treatments and are due to psychobiological mechanisms such as expectancies of the patient. Placebo and nocebo studies have evolved from predominantly methodological research into a far-reaching interdisciplinary field that is unravelling the neurobiological, behavioural and clinical underpinnings of these phenomena in a broad variety of medical conditions. As a consequence, there is an increasing demand from health professionals to develop expert recommendations about evidence-based and ethical use of placebo and nocebo effects for clinical practice.
- A qualitative study of imaginary pills and open-label placebos in test anxietyPublication . Buergler, Sarah; Sezer, Dilan; Busch, Alexander; Enzmann, Marlon; Bakis, Berfin; Locher, Cosima; Bagge, Niels; Kirsch, Irving; Carvalho, Claudia; Gaab, JensBackground The efficacy of open-label placebos (OLPs) has been increasingly demonstrated and their use holds promise for applications compatible with basic ethical principles. Taking this concept one step further an imaginary pill (IP) intervention without the use of a physical pill was developed and tested in a randomized controlled trial (RCT). To explore participants’ experiences and views, we conducted the first qualitative study in the field of IPs. Methods A reflexive thematic analysis (RTA) of semi-structured interviews with test anxious students (N = 20) was nested in an RCT investigating an IP and OLP intervention. In addition, openended questions from the RCT were evaluated (N = 114) to corroborate the RTA and pill characteristics were included to more accurately capture the IP experience. Results Four key themes were identified: (1) attitude towards the intervention, (2) applicability of the intervention, (3) experience of effects, and (4) characteristics of the imagination. The IP intervention was well-accepted, easily applicable, and various effects, pill characteristics and appearances were described. While many participants did not desire a physical pill, either due to the absence of the imagination component or aversion to pills, the approach was considered to be cognitively and time demanding, which in turn, however, encouraged the establishment of a therapeutic ritual that protected against the increase in test anxiety during the preparation phase. OLP findings were comparable, and especially the importance of a treatment rationale was stressed in both groups, counteracting an initial ambivalent attitude. The RTA findings were supported by the open-ended questions of the RCT.IPs appear to be a well-accepted and easily applicable intervention producing a variety of beneficial effects. Thus, the IP approach might serve as an imaginary based alternative to OLPs warranting further investigations on its application to harness placebo effects without a physical pill.
- Imaginary pills and open-label placebos can reduce test anxiety by means of placebo mechanismsPublication . Buergler, Sarah; Sezer, Dilan; Bagge, Niels; Kirsch, Irving; Locher, Cosima; Carvalho, Claudia; Gaab, JensPlacebos have been shown to be beneficial for various conditions even if administered with full transparency. Hence, so-called open-label placebos (OLPs) offer a new way to harness placebo effects ethically. To take this concept one step further, this study aimed at evaluating placebo effects without the use of a physical placebo, i.e., by imagining taking a pill. Healthy students (N = 173) with self-reported test anxiety were either randomized to an imaginary pill (IP; n = 55), an OLP (n = 59) or a control group (CG; n = 59). Both intervention groups were instructed to take two pills daily for three weeks. Primary outcome was test anxiety, secondary outcomes were sleep quality, general well-being and test performance. Groups test anxiety differed at study-endpoint, F(2,169) = 11.50, p < .001. Test anxiety was lower in the intervention groups compared to the CG, t(169) = − 4.44, p < .001, d = − 0.71. The interventions did not differ significantly, i.e., both were similarly efficacious, t(169) = 0.61, p = .540, d = 0.11. The interaction between group and time in explaining test anxiety was significant, F(5,407.93) = 6.13, p < .001. OLPs and IPs reduced test anxiety in healthy participants compared to the CG. This finding opens the door for a novel and ethical method to harness placebo effects.