The roles of expectation, comparator, administration route, and population in open-label placebo effects: A network meta-analysis.

Three meta-analyses have demonstrated the clinical potential of open-label placebos (OLPs). However, there is a need to synthesize the existing evidence through more complex analyses that would make it possible to answer questions beyond mere efficacy. Such analyses would serve to improve the understanding of why and under what circumstances OLPs work (e.g., depending on induced expectations or across different control groups). To answer these questions, we conducted the first network meta-analyses in the field of OLPs. Our analyses revealed that OLPs could be beneficial in comparison to no treatment in nonclinical (12 trials; 1015 participants) and clinical populations (25 trials; 2006 participants). Positive treatment expectations were found to be important for OLPs to work. Also, OLP effects can vary depending on the comparator used. While the kind of administration route had no substantial impact on the OLP effects, effects were found to be larger in clinical populations than in nonclinical populations. These results suggest that the expectation, comparator, administration route, and population should be considered when designing and interpreting OLP studies

Imaginary pills and open‑label placebos can reduce test anxiety by means of placebo mechanisms

Placebos 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 selfreported 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 effect

Imaginary pills and open-label placebos can reduce test anxiety by means of placebo mechanisms

Placebos 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.info:eu-repo/semantics/publishedVersio

Greater than the sum of the parts: a qualitative content analysis of what constitutes a good treatment in the inpatient setting

Background The evaluation of psychotherapy is guided by established concepts, such as efficacy and effectiveness, and acceptability. Although these concepts serve as valid proxies, little is known about corresponding criteria for those directly involved in this treatment. This study aimed to explore inpatients’ and health professionals’ definitions of a good treatment in the inpatient setting. Methods Fifteen semi-structured interviews were conducted in a private psychiatric clinic in Switzerland and structured by qualitative content analysis. Different subsamples of the inpatient setting (patients N = 5; psychiatrists N = 5; other health professionals N = 5) were interviewed. Results In total, 546 text passages were grouped in 10 superordinate categories and identified as relevant for the concept of a good treatment. Participants stressed patient-specific (i.e., new insights; basic attitudes), treatment-specific (i.e., therapy methods and expertise; treatment success; therapy setting), and relationship-based (i.e., communication and feedback; relationships within the clinical setting; overcoming challenges and hurdles) components that are indispensable for a good therapeutic process. Components that are related to the clinical inpatient setting (i.e., setting and organization of the clinic; code of conduct) were also highlighted. Conclusions Patients’ and health professionals’ definitions of what constitutes a good treatment entails a wide array of aspects. The clinical setting is seen to offer unique components that are emphasized to have a healing effect

The therapeutic oxymoron: exploring the mechanisms of open-label placebo

Placebos have emancipated themselves from earlier, often unethical or merely research- based practices, toward an open and thereby ethical administration. Despite a plethora of efficacy studies and nearly two decades of empirical research on open-label placebos (OLPs), little to nothing is known about the circumstances under which they realize their potential. While the underlying processes of deceptive placebos are fairly well understood, these findings cannot simply be transferred to the field of OLPs, given that the two areas most probably operate through distinct mechanisms. To address this research gap, this thesis aims to identify potential explanatory forces behind OLPs. To do the unexploredness justice, a multi-method approach was adopted to shed light on the topic: A network meta-analysis of OLPs (study 1) supports the notion that OLPs can be an efficacious intervention for nonclinical and clinical populations. In particular, this study highlights the importance of inducing positive treatment expectancies, for example, by providing a treatment rationale. The mere administration of a pill without embedding it in a narrative apparently is insufficient, implying that the pill itself might not be a necessary component for OLP effects. This finding was confirmed in a three-week randomized controlled trial (study 2) in which OLPs and the sheer imagination of a pill intake both led to significantly lower test anxiety in students compared to a control group. The presence of a placebo effect solely through means of imagination implies that the daily therapeutic ritual itself evoked beneficial effects. Although these two studies provide valuable insights into OLP mechanisms, they leave the question unanswered as to which participant-related factors play a role in distinct OLP effects. Therefore, a qualitative analysis (study 3) was conducted, in which a central finding was the great extent to what an individual's desire for relief determines the magnitude of the OLP effect. OLP effects can therefore be understood as a relief of symptoms that occurs within the framework of a plausible narrative and a ritual that corresponds to the individual's desire for relief when seeking treatment. Taken together, these three studies suggest, that the words and rituals, as well as the patient's desire for relief, are key determinants responsible for the effect of OLP. A better understanding of the relative weight of each of these components can inform research regarding underlying mechanisms. This, in turn, can assist clinicians in considering or utilizing these mechanisms more frequently in their clinical practice and, where appropriate, communicate the therapeutic value of each element openly

A qualitative study of imaginary pills and open-label placebos in test anxiety

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 IP

The; Healing Encounters and Attitudes Lists; (HEAL): Psychometric Properties of a German Version (HEAL-D) in Comparison With the Original HEAL

Introduction:; Over the last years, the interest in understanding health improvements that occur due to non-specific treatment effects, rather than in response to the specific active treatment ingredients, increased. Nevertheless, investigations on patients' idiosyncratic perspectives on the non-specific aspects of the healing encounter or of the treatment itself that contribute to placebo effects are still rare. The; Healing Encounters and Attitudes Lists; (HEAL) offer a unique and parsimonious set of instruments to measure patients' views on a variety of non-specific aspects of the caring encounter. The HEAL items can be administered as computerized adaptive tests or short forms that assess the; patient-provider connection; , the; healthcare environment; ,; treatment expectancy; ,; positive outlook; ,; spirituality; , as well as; attitudes towards complementary and alternative medicine; . So far, no German version of the HEAL exists.; Methods:; The original 168 HEAL items were translated into German (HEAL-D) applying a translation-back-translation procedure. We examined the psychometric properties of HEAL-D in a sample of 165 participants who reported at least one healthcare visit during the last year.; Results:; The German short forms of HEAL (HEAL-D-SF) showed good internal consistency and test-retest reliability. The factor structure observed in the English original items showed low to moderate model fit in our sample.; Discussion:; The development of a German version of HEAL in addition to the original English items offers new possibilities for investigating patients' idiosyncratic perspectives on the non-specific aspects of treatments across language borders. We will close with presenting possible clinical application as well as promising and relevant future research directions using HEAL-D-SF, including for instance large-scale, cross-national investigations

Lay perspectives of the open-label placebo rationale: a qualitative study of participants in an experimental trial

ObjectivesTo analyse participants’ concepts about the open-label placebo (OLP) effect; to explore their views about the discussion points that are applied in conventional OLP trials and to examine their experiences of taking part in an OLP trial.DesignA qualitative study using thematic analysis of semistructured interviews that were nested within a randomised controlled trial investigating experimental OLP analgesia (registered at ClinicalTrials.gov: NCT02578420).Participants30 healthy adults who took part in the randomised controlled trial.ResultsParticipants mostly conceptualised placebo as something that is inert and requires deception in order to be effective. Interviewees used a broad definition of placebos, going beyond a conventional notion of sugar pills. In contrast to the conventional OLP rationale, participants seldom emphasised classical conditioning as a mechanism of placebo effects, stressing a variety of other well-established components through which placebos might be therapeutic, whereas the conventional OLP disclosures state that ‘a positive attitude helps but is not necessary’, participants in our study applied other attitudes, such as ‘it’s worth a try’. When asked about their experiences during the trial, the majority emphasised that the concept of OLP was completely novel to them. Participants were rather sceptical about the efficacy of the intervention.ConclusionIntegrating lay perspectives into the scientific rationale of OLP treatments might enhance the plausibility and credibility of the rationale in ethical treatments.Trial registration numberNCT02578420

Putting the 'art' into the 'art of medicine': the under-explored role of artifacts in placebo studies.

Research in social psychology demonstrates that physical environmental factors - or "artifacts" such as provider clothing and office décor - can influence health outcomes. However, the role of artifacts in augmenting or diminishing health outcomes is under-explored in the burgeoning discipline of placebo studies. In this paper, we argue that a careful consideration of artifacts may carry significant potential in informing how placebo effects can be maximized, and nocebo effects minimized in clinical settings. We discuss the potential mechanisms, including classical conditioning, response expectancy, and mindsets, by which artifacts might enhance or diminish these effects. Next, we propose testable hypotheses to investigate how placebo and nocebo effects might be elicited by artifacts in care settings, and conclude by providing innovative research designs to advance this novel research agendum

Greater than the sum of the parts: a qualitative content analysis of what constitutes a good treatment in the inpatient setting

Background: The evaluation of psychotherapy is guided by established concepts, such as efficacy and effectiveness, and acceptability. Although these concepts serve as valid proxies, little is known about corresponding criteria for those directly involved in this treatment. This study aimed to explore inpatients’ and health professionals’ definitions of a good treatment in the inpatient setting. Methods: Fifteen semi-structured interviews were conducted in a private psychiatric clinic in Switzerland and structured by qualitative content analysis. Different subsamples of the inpatient setting (patients N = 5; psychiatrists N = 5; other health professionals N = 5) were interviewed. Results: In total, 546 text passages were grouped in 10 superordinate categories and identified as relevant for the concept of a good treatment. Participants stressed patient-specific (i.e., new insights; basic attitudes), treatment-specific (i.e., therapy methods and expertise; treatment success; therapy setting), and relationship-based (i.e., communication and feedback; relationships within the clinical setting; overcoming challenges and hurdles) components that are indispensable for a good therapeutic process. Components that are related to the clinical inpatient setting (i.e., setting and organization of the clinic; code of conduct) were also highlighted. Conclusions: Patients’ and health professionals’ definitions of what constitutes a good treatment entails a wide array of aspects. The clinical setting is seen to offer unique components that are emphasized to have a healing effect