Author Correction: Effects of open-label placebos in clinical trials: a systematic review and meta-analysis

Wernsdorff, Melina von; Loef, Martin; Tuschen‐Caffier, Brunna; Schmidt, Stefan

doi:10.1038/s41598-021-96604-0

Cited by 4 publications

(6 citation statements)

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“…If the aim is to create similar levels of patient expectations of benefit, then studies need to explore whether this can be achieved with very dissimilar controls 68 , 127 , 169 or even unblinded designs. 164 If the aim is to control for context effects or study treatment mechanisms, then a careful matching is likely beneficial. 125 Blinding to sham allocation alone may also be achieved with very dissimilar but equally credible interventions, as illustrated by 2 reviewed trials that assessed blinding success.…”

Section: Discussionmentioning

confidence: 99%

Blinding and sham control methods in trials of physical, psychological, and self-management interventions for pain (article I): a systematic review and description of methods

Hohenschurz-Schmidt

Draper-Rodi

Vase

et al. 2022

Pain

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Section: Discussionmentioning

confidence: 99%

Blinding and sham control methods in trials of physical, psychological, and self-management interventions for pain (article I): a systematic review and description of methods

Hohenschurz-Schmidt

Draper-Rodi

Vase

et al. 2022

Pain

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“…This is of special interest in the area of pain where placebo effects and placebo responses have been long recognized and are well investigated. OLPs have been shown to be effective in some clinical populations [see (11,12) for an overview], e.g., in chronic low back pain (13,(15)(16)(17). In addition, there are promising results by several experimental OLP analgesia studies (7,8,(32)(33)(34).…”

Section: Discussionmentioning

confidence: 99%

“…Reported effects sizes for OLP effects in clinical and subclinical trials are generally medium to large (11,12) with overall Standardized Mean Differences (SMD) of 0.72-0.88. The confidence intervals reported in the larger meta-analysis by von Wernsdorff, Loef et al (12) suggests that there is substantial variability in the observed effect sizes among the different studies, ranging from SMD 0.39 to 1.05. Therefore, using the statistical software G * Power we conducted a conservative power calculation on the basis of an F-test for an ANCOVA for two groups.…”

Section: Sample Sizementioning

confidence: 99%

“…Placebo effects have been shown to have a clinically significant impact on subjective and objective health outcomes for a variety of somatic and mental disorders (1,2). However, since the administration of deceptive placebo violates patients' right to autonomy [e.g., (3,4)], alternative means of harnessing the placebo effect in an ethical manner-so-called Open-Label Placebos (OLP)-have been proposed and found to be effective in both healthy (5)(6)(7)(8)(9)(10) as well as clinical populations [see (11,12) for an overview].…”

Section: Introductionmentioning

confidence: 99%

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Open-Label Placebo Treatment for Acute Postoperative Pain (OLP-POP Study): Study Protocol of a Randomized Controlled Trial

et al. 2021

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Introduction: Open-label placebos have been proposed as way of using long recognized analgesic placebo effects in an ethical manner. Recent evidence shows efficacy of open-label placebos for clinical conditions, but there is need for more research on open-label placebos in acute pain. In the treatment of acute postoperative pain, minimization of opioid related side effects remains one of the key challenges. Therefore, this study aims at investigating the potential of adding unconditioned open-label placebos to treatment as usual as a means of reducing opioid consumption and its related side effects in patients with acute postoperative pain.Methods and Analysis: This is the protocol of an ongoing single site randomized controlled trial. The first patient was enrolled in May 2020. In total, 70 patients suffering from acute postoperative pain following dorsal lumbar interbody fusion are randomized to either a treatment as usual group or an experimental intervention group. The treatment as usual group consists of participants receiving a patient-controlled morphine pump. On day 1 and 2 post-surgery, patients in the intervention group receive, in addition to treatment as usual, two open-label placebo injections per day along with an evidence-based treatment rationale explaining the mechanisms of placebos. The primary outcome is measured by means of self-administered morphine during day 1 and 2 post-surgery. Several other outcome measures including pain intensity and adverse events as well as potential predictors of placebo response are assessed. Analysis of covariance will be used to answer the primary research question and additional statistical techniques such as generalized linear mixed models will be applied to model the temporal course of morphine consumption.Discussion: This study will provide valuable insights into the efficacy of open-label placebos in acute pain and will potentially constitute an important step toward the implementation of open-label placebos in the clinical management of acute postoperative pain. In addition, it will shed light on a cost-efficient and patient-centered strategy to reduce opioid consumption and its related side effects, without any loss in pain management efficacy.Ethics and Dissemination: The “Ethikkommission Nordwest- und Zentralschweiz” (BASEC2020-00099) approved the study protocol. Results of the analysis will be submitted for publication in a peer-reviewed journal.Clinical Trial Registration: The study is registered at ClinicalTrials.gov (NCT04339023) and is listed in the Swiss national registry at kofam.ch (SNCTP000003720).

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“…Some placebo researchers have suggested that the physical action of taking a pill is a key active component of an OLP condition ( [7,8]; for a discussion see [9]). Therefore, an instruction that has been used in numerous OLP studies includes the following points: '(1) the placebo effect is powerful, (2) the body can automatically respond to taking placebo pills, like Pavlov's dogs who salivated when they heard a bell, (3) a positive attitude helps but is not necessary, and (4) taking the pills faithfully is critical.' ( [10], p. 2).…”

Section: Introductionmentioning

confidence: 99%

Reducing Emotional Distress with Open-Label Placebos: Assessing the Role of Motor Engagement in Pill Consumption

Schienle,

Kogler

2024

Behavioral Sciences

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It has been posited that ingesting a pill constitutes a pivotal action that facilitates the effects of open-label placebos (OLPs: placebos honestly prescribed). In the present OLP experiment, the motor components of a placebo treatment were systematically varied. The participants (n = 183) were randomly allocated to one of four groups that all viewed aversive pictures. The ‘active OLP’ group took a placebo pill with specific instructions concerning the sequence of motor actions for the intake. The ‘usual OLP’ group swallowed the pill (without specific motor instructions), while the third group received an ‘imaginary OLP’ (no pill intake). The fourth group applied cognitive reappraisal (CR; active control group) to reduce emotional distress. The participants rated their affective state as well as the efficacy and plausibility of the treatment approach. Moreover, blood pressure and pulse were recorded as indicators of bodily arousal. The four groups did not differ in their valence ratings and physiological measures. The ‘imaginary OLP’ received higher ratings for both effectiveness and plausibility than the ‘usual OLP’. CR was rated as superior relative to all OLP conditions. In conclusion, reducing emotional distress with OLPs does not necessitate the consumption of a placebo pill. In terms of acceptability and ease of implementation, CR stands as a well-established alternative.

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Author Correction: Effects of open-label placebos in clinical trials: a systematic review and meta-analysis

Cited by 4 publications

References 0 publications

Blinding and sham control methods in trials of physical, psychological, and self-management interventions for pain (article I): a systematic review and description of methods

Blinding and sham control methods in trials of physical, psychological, and self-management interventions for pain (article I): a systematic review and description of methods

Open-Label Placebo Treatment for Acute Postoperative Pain (OLP-POP Study): Study Protocol of a Randomized Controlled Trial

Reducing Emotional Distress with Open-Label Placebos: Assessing the Role of Motor Engagement in Pill Consumption

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