Can the Open Label Placebo Rationale Be Optimized?

Heiss, Uwe; Rosenfield, Maayan; Bernstein, Michael H.

doi:10.3389/fpain.2021.734882

Cited by 3 publications

(6 citation statements)

References 29 publications

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“…Our study identified the importance to patients of establishing clinical effectiveness of placebo interventions. This also suggested the importance of studying how best to communicate OLP rationale (Heiss et al, 2021; Locher et al, 2017). The preference of DP or OLP seemed to be an individual choice and further studies into what motivates one or the other intervention, for what condition and for whom, are recommended.…”

Section: Discussionmentioning

confidence: 99%

“…Perhaps most importantly, it is necessary to probe whether patients themselves consider deceptive placebos to be unethical (Bishop et al, 2014). However, aside from the transparency in its administration, there is little information today about the information given or not to the patient during the administration of an OLP (Heiss et al, 2021; von Wernsdorff et al, 2021), or whether patients find these treatments acceptable (Blease, 2019).…”

Section: Introductionmentioning

confidence: 99%

“…This study looked at lay people's attitudes towards OLP treatments after use focused on the rationale rather than the acceptability of the treatment (Locher et al, 2021) without informing participants of the existence of OLP treatments in the non‐OLP groups. Again, however, there are documented discrepancies in how the information is communicated to participants during the administration of OLPs in clinical trials (Heiss et al, 2021; von Wernsdorff et al, 2021). These differences could influence the acceptability of the intervention.…”

Section: Introductionmentioning

confidence: 99%

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‘It's not my greengrocer, it's someone from the medical profession’: A qualitative study regarding acceptability of deceptive and open‐label placebo prescribing in France

Druart

Vauthrin

Pinsault

et al. 2022

British J Health Psychol

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Objectives: To explore participants' views regarding clinical use of deceptive placebo (DP) and open-label placebo (OLP) treatments. Design: Qualitative thematic analysis. Methods: We conducted eight semi-structured interviews with healthy participants in an experimental trial comparing the efficacy of OLP and DP (Clinical trials n°NCT03934138).Interviewees' opinions were solicited following administration of placebos during the trial. Interviews were analysed using data-driven analysis. Results: We identified three themes. First, participants considered trust central in judging a placebo treatment to be acceptable. They expressed the importance of an implicit trust both in their health care professionals' (HCPs') competency as well as in the profession at large. A second theme was the perception of how placebo treatments might solve health problems. Acceptability of both types of placebo treatments was dependent on the perception patients had about the treatment solving their problem and/or doubts regarding the effectiveness of placebos The third theme encompassed perceived risks associated with placebo prescribing. Some

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Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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‘It's not my greengrocer, it's someone from the medical profession’: A qualitative study regarding acceptability of deceptive and open‐label placebo prescribing in France

Druart

Vauthrin

Pinsault

et al. 2022

British J Health Psychol

View full text Add to dashboard Cite

show abstract

“…OLPs in clinical trials have been administered with highly variable rationales (von Wernsdorff et al, 2021). In contrast, some authors have suggested key information to include in the OLP rationale (Heiss et al, 2021). In our study, we chose a video format with mostly informative content.…”

Section: Findings and Interpretationsmentioning

confidence: 99%

“…Similarly, when administering DPs, information about treatment mechanisms boosts the placebo response (Tang & Colagiuri, 2013). However, in published trials on OLPs, there are important variations in the rationale given to patients before treatment administration (Heiss et al., 2021; von Wernsdorff et al., 2021). These variations mean clinical applications might depend on the rationale given by the therapist.…”

Section: Introductionmentioning

confidence: 99%

If only they knew! A non‐inferiority randomized controlled trial comparing deceptive and open‐label placebo in healthy individuals

Druart,

Graham Longsworth,

Terrisse

et al. 2023

European Journal of Pain

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BackgroundPlacebo use is widespread in clinical practice. However, they are most often administered deceptively rather than openly. It is often suggested that open‐label placebos (OLP) are less effective than deceptive placebos (DP). This study aimed to compare the use of DP and OLP treatments to reduce pain in healthy volunteers.MethodsWe conducted a non‐inferiority, parallel, randomized, controlled trial, which also included a nested cross‐over no‐treatment condition. This study was conducted at a university clinic in France.ResultsWe included 60 subjects and the main result shows that the OLP was not inferior to the DP by a margin of 10 mm. The mean difference between both groups regarding intensity of pain was 0.7 mm with a 95% compatibility interval (95% CI) of ]−∞; 5.4], and 97.5% CI of ]−∞; 6.3]. Secondary outcomes require cautious interpretation of the effect of placebo versus no treatment due to a time–treatment interaction.ConclusionThe study indicates that OLP may perform just as well as DP and could provide support for the use of OLP as an ethical alternative to DP when they are to be used in a clinical setting. If only patients knew about the placebo nature of some treatments they are receiving, unnecessary lies could be avoided while maintaining similar placebo effects.SignificanceThis study is the first to show non‐inferiority of placebos administered honestly, also called OLP, compared to DP in reducing pain. This suggests that OLP could be as effective as their deceptive counterparts while having the ethical advantage of not being required to lie. If deception is not a necessary condition for efficacy, OLP should be preferred over DP.

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Preoperative Anxiolysis and Treatment Expectation (PATE Trial): open-label placebo treatment to reduce preoperative anxiety in female patients undergoing gynecological laparoscopic surgery – study protocol for a bicentric, prospective, randomized-controlled trial

Wessels,

Klinger,

Benson

et al. 2024

Front. Psychiatry

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One of the most common concerns of patients undergoing surgery is preoperative anxiety, with a prevalence of up to 48%. The effects of preoperative anxiety continue beyond the preoperative period and are associated with more severe postoperative pain and poorer treatment outcomes. Treatment options for preoperative anxiety are often limited as sedatives cause side effects and their efficacy remains controversial. Placebo research has shown that optimization of positive treatment expectations, as can be achieved through placebo administration and education, has clinically relevant effects on preoperative anxiety, pain and treatment outcomes. As the administration of masked placebos raises ethical questions, clinical studies have increasingly focused on the use of open, non-deceptive placebo administration (open-label placebo, OLP). The use of OLPs to reduce preoperative anxiety and modify clinically relevant postoperative outcomes has not yet been investigated. This bicentric, prospective, randomized-controlled clinical trial (PATE Trial; German Registry for Clinical Studies DRKS00033221), an associated project of the Collaborative Research Center (CRC) 289 “Treatment Expectation”, aims to alleviate preoperative anxiety by optimizing positive treatment expectations facilitated by OLP. Furthermore, this study examines a potential enhancement of these effects through aspects of observational learning, operationalized by a positive expectation-enhancing video. In addition, patient’s perspective on the self-efficacy and appropriateness of OLPs prior to surgery will be assessed. To achieve these objectives, female patients will be randomized into three groups before undergoing gynecological laparoscopic surgery. One group receives the OLP with a positive rationale conveyed by a study physician. A second group receives the same intervention, OLP administration and rationale provided by a physician, and additionally watches a video on OLP presenting a satisfied patient. A third group receives standard treatment as usual (TAU). Outcome measures will be effects on preoperative anxiety and postoperative experience, particularly visceral and somatic postoperative pain. As the non-deceptive administration of placebos; when indicated; may yield positive outcomes without side effects, and as current treatment of preoperative anxiety is limited, evidence from clinical placebo research has the potential to improve outcomes and patient experience in the surgical setting.

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Can the Open Label Placebo Rationale Be Optimized?

Cited by 3 publications

References 29 publications

‘It's not my greengrocer, it's someone from the medical profession’: A qualitative study regarding acceptability of deceptive and open‐label placebo prescribing in France

‘It's not my greengrocer, it's someone from the medical profession’: A qualitative study regarding acceptability of deceptive and open‐label placebo prescribing in France

If only they knew! A non‐inferiority randomized controlled trial comparing deceptive and open‐label placebo in healthy individuals

Preoperative Anxiolysis and Treatment Expectation (PATE Trial): open-label placebo treatment to reduce preoperative anxiety in female patients undergoing gynecological laparoscopic surgery – study protocol for a bicentric, prospective, randomized-controlled trial

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