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Journal of Psychosomatic Research Sep 2023Placebo responses are significantly higher in children than in adults, suggesting a potential underused treatment option in pediatric care. To facilitate the clinical...
OBJECTIVE
Placebo responses are significantly higher in children than in adults, suggesting a potential underused treatment option in pediatric care. To facilitate the clinical translation of these beneficial effects, we explored physicians' current practice, opinions, knowledge, and likelihood of recommending placebos in the future.
METHODS
A cross-sectional web-based survey administered by REDCap was conducted at Boston Children's Hospital between October 2021 and March 2022. Physicians (n = 1157) were invited to participate through an email containing a link to a 23-item survey designed to assess physicians' attitudes and perceptions towards the clinical use of placebo in pediatrics.
RESULTS
From 207 (18%) returned surveys, 109 (9%) were fully completed. Most respondents (79%) believed that enhancing the therapeutic components that contribute to the placebo response may be a way of improving pediatric care. However, whereas most (62%) found placebo treatments permissible, only one-third reported recommending them. In pediatrics, placebos are typically introduced as a medicine that "might help" (43%). The most common treatments recommended to enhance placebo effects are physical therapy, vitamins, and over-the-counter analgesics. Physicians most frequently recommend placebos for occasional pain, headaches, and anxiety disorders. Finally, the great majority of physicians (87%) stated they would be more likely to recommend placebo treatments if there were safety and ethical guidelines for open-label placebos.
CONCLUSIONS
Placebo treatments seem permissible to physicians in pediatric care, but the development of safety and ethical guidelines may be necessary before physicians systematically incorporate the benefits of the placebo effect in pediatrics.
Topics: Child; Humans; Attitude of Health Personnel; Cross-Sectional Studies; Pediatrics; Physicians; Practice Patterns, Physicians'; Surveys and Questionnaires
PubMed: 37354748
DOI: 10.1016/j.jpsychores.2023.111421 -
Pain Nov 2023Observing someone experience pain relief or exacerbation after an intervention may induce placebo hypoalgesia or nocebo hyperalgesia. Understanding the factors that... (Meta-Analysis)
Meta-Analysis
Observing someone experience pain relief or exacerbation after an intervention may induce placebo hypoalgesia or nocebo hyperalgesia. Understanding the factors that contribute to these effects could help in the development of strategies for optimizing treatment of chronic pain conditions. We systematically reviewed and meta-analyzed the literature on placebo hypoalgesia and nocebo hyperalgesia induced by observational learning (OL). A systematic literature search was conducted in the databases PubMed, PsycINFO, Web of Science, ScienceDirect, PsycARTICLES, Scopus, and Academic Search Ultimate. Twenty-one studies were included in the systematic review, 17 of which were suitable for meta-analysis (18 experiments; n = 764 healthy individuals). The primary end point was the standardized mean difference (SMD) for pain following placebo cues associated during OL with low vs high pain. Observational learning had a small-to-medium effect on pain ratings (SMD 0.44; 95% confidence interval [CI] 0.21-0.68; P < 0.01) and a large effect on pain expectancy (SMD 1.11; 95% CI 0.49-2.04; P < 0.01). The type of observation (in-person vs videotaped) modulated the magnitude of placebo hypoalgesia/nocebo hyperalgesia ( P < 0.01), whereas placebo type did not ( P = 0.23). Finally, OL was more effective when observers' empathic concern (but no other empathy-related factors) was higher ( r = 0.14; 95% CI 0.01-0.27; P = 0.03). Overall, the meta-analysis demonstrates that OL can shape placebo hypoalgesia and nocebo hyperalgesia. More research is needed to identify predictors of these effects and to study them in clinical populations. In the future, OL could be an important tool to help maximize placebo hypoalgesia in clinical settings.
Topics: Humans; Hyperalgesia; Nocebo Effect; Pain; Learning; Pain Perception; Placebo Effect
PubMed: 37326688
DOI: 10.1097/j.pain.0000000000002943 -
BMC Medical Education Jul 2024The effects of many treatments in healthcare are determined by factors other than the treatment itself. Patients' expectations and the relationship with their healthcare...
BACKGROUND
The effects of many treatments in healthcare are determined by factors other than the treatment itself. Patients' expectations and the relationship with their healthcare provider can significantly affect treatment outcomes and thereby play a major role in eliciting placebo and nocebo effects. We aim to develop and evaluate an innovative communication training, consisting of an e-learning and virtual reality (VR) training, for healthcare providers across all disciplines, to optimize placebo and minimize nocebo effects through healthcare provider-patient communication. The current paper describes the development, mid-term evaluation, optimization, and final evaluation of the communication training, conducted in The Netherlands.
METHODS
The development of both the e-learning and the VR training consisted of four phases: 1) content and technical development, 2) mid-term evaluation by healthcare providers and placebo/communication researchers, 3) optimization of the training, and 4) final evaluation by healthcare providers. To ensure the success, applicability, authenticity, and user-friendliness of the communication training, there was ongoing structural collaboration with healthcare providers as future end users, experts in the field of placebo/communication research, and educational experts in all phases.
RESULTS
Placebo/communication researchers and healthcare providers evaluated the e-learning positively (overall 7.9 on 0-10 scale) and the content was perceived as useful, accessible, and interesting. The VR training was assessed with an overall 6.9 (0-10 scale) and was evaluated as user-friendly and a safe method for practicing communication skills. Although there were some concerns regarding the authenticity of the VR training (i.e. to what extent the virtual patient reacts like a real patient), placebo and communication researchers, as well as healthcare providers, recognized the significant potential of the VR training for the future.
CONCLUSIONS
We have developed an innovative and user-friendly communication training, consisting of an e-learning and VR training (2D and 3D), that can be used to teach healthcare providers how to optimize placebo effects and minimize nocebo effects through healthcare provider-patient communication. Future studies can work on improved authenticity, translate the training into other languages and cultures, expand with additional VR cases, and measure the expected effects on providers communication skills and subsequently patient outcomes.
Topics: Humans; Virtual Reality; Placebo Effect; Nocebo Effect; Communication; Netherlands; Health Personnel; Physician-Patient Relations; Computer-Assisted Instruction; Female
PubMed: 38951784
DOI: 10.1186/s12909-024-05671-0 -
Scandinavian Journal of Psychology Aug 2023This study examined the placebo and nocebo effects of conditioning and induced expectations on executive function after acute aerobic exercise. The results showed that...
This study examined the placebo and nocebo effects of conditioning and induced expectations on executive function after acute aerobic exercise. The results showed that the benefits of exercise on executive function were influenced by both conditioning and induced expectations. Further, positive conditioning or expectations enhanced cognitive benefits, negative conditioning or expectations reduced cognitive benefits, but induced expectations on executive function were not moderated by conditioning. This study revealed and quantitively estimated the placebo and nocebo effects in improving executive function after acute aerobic exercise, providing evidence to advance the understanding of the cognitive benefits of exercise.
Topics: Humans; Nocebo Effect; Placebo Effect; Executive Function
PubMed: 36659821
DOI: 10.1111/sjop.12900 -
European Journal of Pediatrics Sep 2023To analyze the efficacy of using honey to treat acute cough in children. Systematic review, synthesis without meta-analysis. We searched PubMed, Scopus, CENTRAL,...
UNLABELLED
To analyze the efficacy of using honey to treat acute cough in children. Systematic review, synthesis without meta-analysis. We searched PubMed, Scopus, CENTRAL, CINAHL, and Web of Science databases on August 15, 2022, for words honey and cough. Randomized controlled trials conducted in children were included. Risk-of-bias and evidence quality were assessed. Studies were not pooled due to lack of key information. Instead, we provided the range of observed effects for the main outcomes. Three hundred ninety-six papers were screened, and 10 studies were included. Two studies had high risk-of-bias and six had some concerns. Honey seemed to decrease cough frequency more than placebo/no treatment (range of observed effect 0.0-1.1 points) and cough medication (0.2-0.9 points). Sleep improved more often in the honey group (range of effect was 0.0-1.1) compared to placebo/no treatment and (- 0.2-1.1 points) compared to cough medication. Quality of the evidence was low to very low.
CONCLUSION
We found low quality evidence that honey may be more effective than cough medication or placebo/no treatment in relieving symptoms and improving sleep in children with acute cough. Better quality randomized, placebo-controlled blinded trials are needed to confirm the effectiveness of honey in treating acute cough in children.
TRIAL REGISTRATION
CRD42022369577.
WHAT IS KNOWN
• Honey has been suggested to be effective as a symptomatic treatment in acute cough. • Prior randomized trials have had conflicting results and thus an overview of the literature was warranted.
WHAT IS NEW
• Based on low quality evidence honey may be more effective than placebo or over-the-counter medications for acute symptom reliwef in cough. • Future studies with better reporting are needed to confirm the results.
PubMed: 37355498
DOI: 10.1007/s00431-023-05066-1 -
European Journal of Pain (London,... Apr 2024The magnitude of placebo effects from physical and psychological 'sham' is unknown but could impact efficacy trials and treatment understanding. To quantify placebo... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
The magnitude of placebo effects from physical and psychological 'sham' is unknown but could impact efficacy trials and treatment understanding. To quantify placebo effects, this systematic review of three-armed randomised controlled trials (RCTs) of physical and psychological interventions for pain compared outcomes in 'sham' control intervention and non-exposure arms.
METHODS
RCTs with treatment, 'sham' control intervention, and non-exposure groups were included, enrolling adults with any pain. A protocol was pre-registered (PROSPERO: CRD42023413324), and twelve databases searched from 2008 to July 2023. Trial methods and blinding were analysed descriptively and risk of bias assessed. Meta-analysis of pain measures at short-, medium- and long-term was performed with random-effects models of standardised mean differences (SMD).Studies were sub-grouped according to control intervention type.
RESULTS
Seventeen RCTs were included. The average short-term placebo effect was small (0.21 SMD, 0.1-0.33 95% CI, p = 0.0002, 1440 participants). It showed no heterogeneity (Tau = 0.1, I = 11%, p = 0.3), preventing meta-regression analyses of effect modifiers. However, sub-group analyses revealed larger placebo effects in manual control interventions compared to disabled devices and miscellaneous control interventions. Overall, placebo analgesia accounted for 39% of treatments' short-term effectiveness. No placebo effects were found at medium-term (7 RCTs, 381 participants) or long-term follow-up (3 RCTs, 173 participants).
CONCLUSIONS
The observed placebo analgesia has mechanistic and methodological implications, though its clinical importance may be limited. Control intervention design affects placebo effects, highlighting the importance of considering methodology in RCT interpretation. Review limitations include a small number of long-term studies and sample heterogeneity.
SIGNIFICANCE
This systematic review directly quantifies placebo effects from physical and psychological 'sham' control interventions and compares them to treatments' overall effectiveness. By doing so, the review enhances our understanding of placebo effects, their relative contribution in clinical trials, and their susceptibly to trial design. It poses further questions regarding the influence of blinding, participant expectations, and features of the therapeutic context. Overall, the insights provided by this review carry methodological significance and are important for the interpretation and synthesis of efficacy trials in this field.
Topics: Adult; Humans; Analgesia; Pain
PubMed: 37985188
DOI: 10.1002/ejp.2205 -
BMC Medical Research Methodology Feb 2024The importance of contextual effects and their roles in clinical care controversial. A Cochrane review published in 2010 concluded that placebo interventions lack... (Review)
Review
The importance of contextual effects and their roles in clinical care controversial. A Cochrane review published in 2010 concluded that placebo interventions lack important clinical effects overall, but that placebo interventions can influence patient-reported outcomes such as pain and nausea. However, systematic reviews published after 2010 estimated greater contextual effects than the Cochrane review, which stems from the inappropriate methods employed to quantify contextual effects. The effects of medical interventions (i.e., the total treatment effect) can be divided into three components: specific, contextual, and non-specific. We propose that the most effective method for quantifying the magnitude of contextual effects is to calculate the difference in outcome measures between a group treated with placebo and a non-treated control group. Here, we show that other methods, such as solely using the placebo control arm or calculation of a 'proportional contextual effect,' are limited and should not be applied. The aim of this study is to provide clear guidance on best practices for estimating contextual effects in clinical research.
PubMed: 38350852
DOI: 10.1186/s12874-024-02152-2 -
Applied Psychology. Health and... May 2024Augmented patient-practitioner interactions that enhance therapeutic alliance can increase the placebo effect to sham treatment. Little is known, however, about the... (Randomized Controlled Trial)
Randomized Controlled Trial
Augmented patient-practitioner interactions that enhance therapeutic alliance can increase the placebo effect to sham treatment. Little is known, however, about the effect of these interactions on maladaptive health outcomes (i.e., the nocebo effect). Healthy participants (N = 84) were randomised to a 3-day course of Oxytocin nasal drops (actually, sham treatment) in conjunction with a high-warmth interaction (Oxy-HW: N = 28), a low-warmth interaction (Oxy-LW: N = 28) or to a no treatment control group (NT: N = 28). All participants were informed that the Oxytocin treatment could increase psychological well-being but was associated with several potential side effects. Treatment-related side effects, unwarned symptoms, and psychological well-being were measured at baseline and all post-treatment days. Side effect reporting was increased in the Oxy-LW condition compared to the other groups across all days. Conversely, increased psychological well-being was observed in the Oxy-HW condition, relative to the other conditions, but only on Day 1. Among those receiving treatment, positive and negative expectations, and treatment-related worry, did not vary by interaction-style, while psychological well-being and side effect reporting were inversely associated at the level of the individual. Results have important implications for practice, suggesting poorer quality interactions may not only reduce beneficial health outcomes but also exacerbate those that are maladaptive.
Topics: Humans; Nocebo Effect; Female; Male; Adult; Placebo Effect; Empathy; Young Adult; Oxytocin; Administration, Intranasal; Professional-Patient Relations
PubMed: 37793644
DOI: 10.1111/aphw.12497 -
British Journal of Pain Aug 2023Pain is an unpleasant sensory and emotional experience that affects people's physical, mental, and social health. Patients at times present with postoperative pain with...
BACKGROUND AND OBJECTIVES
Pain is an unpleasant sensory and emotional experience that affects people's physical, mental, and social health. Patients at times present with postoperative pain with no clinical signs after the surgical dental procedures and adequate pharmacological management. This can be due to the amplified emotional component of the individual in their postoperative period. Hence, this study aimed to estimate the association between placebo, nocebo effects, and postoperative pain associated with tooth extraction procedures.
METHODS
A cross-sectional study was conducted among 301 patients attending the Department of Oral and Maxillofacial Surgery for tooth extraction. Preoperatively, the expected postoperative pain score was recorded using the "Numerical Rating Scale" (NRS), Anxiety and Depression were assessed using the "Hospital Anxiety and Depression Scale" (HADS), and Patients' expectancy regarding the treatment outcome was assessed using the "Credibility Expectancy Questionnaire" (CEQ). Observed postoperative pain scores at the 6th hour, 24th hour, and peak pain score of the day were recorded using the NRS.
RESULTS
There were statistically significant associations ( < 0.05) found between expected and observed postoperative pain, preoperative anxiety and observed postoperative pain, preoperative depression and observed postoperative pain, placebo, nocebo effects, and observed postoperative pain.
INTERPRETATION AND CONCLUSION
Our study showed a strong association between these variables suggesting that post-extraction pain is a multifaceted condition wherein pain expectation, preoperative anxiety, depression, and expectancy regarding the treatment outcome should be scrutinized before the extraction procedure.
PubMed: 37538946
DOI: 10.1177/20494637231161915 -
Perspectives on Psychological Science :... Sep 2023The Bayesian-brain framework applied to placebo responses and other mind-body interactions suggests that the effects on the body result from the interaction between...
The Bayesian-brain framework applied to placebo responses and other mind-body interactions suggests that the effects on the body result from the interaction between priors, such as expectations and learning, and likelihood, such as somatosensorial information. Significant research in this area focuses on the role of the priors, but the relevance of the likelihood has been surprisingly overlooked. One way of manipulating the relevance of the likelihood is by paying attention to sensorial information. We suggest that attention can influence both precision and position (i.e., the relative distance from the priors) of the likelihood by focusing on specific components of the somatosensorial information. Two forms of attention seem particularly relevant in this framework: mindful attention and selective attention. Attention has the potential to be considered a "major player" in placebo/nocebo research, together with expectations and learning. In terms of application, relying on attentional strategies as "amplifiers" or "silencers" of sensorial information could lead to an active involvement of individuals in shaping their care process and health. In this contribution, we discuss the theoretical implications of these intuitions with the aim to provide a comprehensive framework that includes Bayesian brain, placebo/nocebo effects, and the role of attention in mind-body interactions.
Topics: Humans; Nocebo Effect; Bayes Theorem; Placebo Effect; Brain; Learning
PubMed: 36656800
DOI: 10.1177/17456916221141383