Placebo

Basic and Clinical Research Exploring Acupuncture Therapy for Pain

Acupuncture in an ancient medical technique originated in China. By inserting thin needles into body at specific anatomical locations, improvements in a range of symptoms, especially painful conditions, have been reported empirically and by many meta-analyses of clinical trials. However, the therapeutic values of acupuncture for pain management are fraught with controversy, largely due to difficulty to dissociate specific effects of acupuncture needling techniques from non-specific therapeutic effects such as placebo effects and social interaction as well as ambiguity in acupuncture’s effects on clinical outcomes and physiological mechanisms. As the United States is combating an opioid crisis and the underlying challenges of pain management, acupuncture has emerged as a prominent complementary solution. Better understanding of how and whether acupuncture works for pain relief is now critical as we consider the possibility of its broader usage for pain management. This session will bring four speakers, Dr. Wen G. Chen from NCCIH/NIH, Dr. Vitaly Napadow from Harvard Medical School, Dr. Karen Sherman from the Kaiser Permanente Washington Health Research Institute, and Dr. Claudia Witt from the University of Zurich, to present and discuss the current scientific research and implementation challenges for acupuncture and pain.

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Effectiveness and Cost-Effectiveness of Acupuncture

For decision makers in healthcare the effectiveness of acupuncture is one relevant aspect. In an NIH-funded patient-level data meta-analyses it was found that acupuncture for back and neck pain, shoulder pain, osteoarthritis, and headache and migraine had a statistically significant and clinically relevant effect when compared to non-acupuncture controls. Result as well as confounding and effect moderating factors will be critically discussed. In times of limited resources for health care, economic analyses are a useful tool to provide information that can support economically reasonable decisions. Over the last 15 years several cost-effectiveness on acupuncture for chronic pain were published and summarized the systematic reviews, showing that the provision of acupuncture could be cost effective.

Key insights: The workshop participants will get insights into the critical reflected interpretation of the available effectiveness and cost-effectiveness data on acupuncture for chronic pain. They will gain knowledge about factors contributing to the size of the acupuncture effect. Furthermore, they will learn about basic methodological aspects of pragmatic trials and cost-effectiveness analyses and their advantages and limitations.

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Basic, Mechanistic, and Clinical Research Exploring Acupuncture Therapy for Pain: an NIH perspective

Dr. Chen will introduce the panel and speakers, provide an overview and international scope of acupuncture research, highlight some recent advances in basic, mechanistic, and clinical acupuncture and pain research, and moderate the session. Acupuncture in an ancient medical technique originated in China. By inserting thin needles into body at specific anatomical locations, improvements in a range of symptoms, especially painful conditions, have been reported empirically and by many meta-analyses of clinical trials.  However, the therapeutic values of acupuncture for pain management are fraught with controversy, largely due to difficulty to dissociate specific effects of acupuncture needling techniques from non-specific therapeutic effects such as placebo effects and social interaction as well as ambiguity in acupuncture’s effects on clinical outcomes and physiological mechanisms.  As the United States is combating an opioid crisis and the underlying challenges of pain management, acupuncture has emerged as a prominent complementary solution.  Better understanding of how and whether acupuncture works for pain relief is now critical as we consider the possibility of its broader usage for pain management. Recent advances on basic mechanisms by which acupuncture may exert its therapeutic effects, including work by Dr. Qiufu Ma funded by NCCIH, will be highlighted.

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Acupuncture for Chronic Pain: Evaluating the Evidence on Efficacy, Effectiveness and the Question of Benefits

Even though acupuncture is recommended in guidelines for some pain conditions, there remains uncertainty about the evidence regarding its efficacy, primarily due to the question of how well  acupuncture outperforms placebo. In this presentation,  high quality evidence will be shared from the NIH-funded Acupuncture Triallists Collaboration on the following chronic pain conditions: back and neck pain, shoulder pain, osteoarthritis, and headache and migraine. Reporting on the analysis of individual patient data from 39 international trials with over 20,000 patients, the findings show that acupuncture has a small yet statistically significant beneficial effect when compared to sham acupuncture controls. However, acupuncture had a statistically significant and clinically relevant effect when compared to non-acupuncture controls. In this presentation, a thorough discussion of this paradox, including a review of the purpose and assumptions of both efficacy and pragmatic trials as well as conceptual and practical ways of resolving this paradox will be undertaken. Finally, because of the urgent need to move forward evaluating potentially viable alternatives to medications in some types of pain patients, the design of a new large NIH funded pragmatic trial of acupuncture in older adults will be presented as a promising approach at this stage of our knowledge. 

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Demystifying Mechanisms of Placebo Effects Across the Lifespan

The placebo effect is one of the most striking and well-known demonstrations of the mind’s influence on the experience of pain. While for decades clinical trials have aimed to reduce the placebo effect, there is growing interest in leveraging the placebo effect to improve pain treatments and to relieve suffering. This includes moving beyond a narrow understanding of the placebo effect as expectations for a placebo pill, and instead moving towards an understanding that the brain’s ‘inner pharmacy’ can be leveraged in a variety of ways through clinical care. To effectively leverage these placebo effects in clinical care, it is essential to understand their psychological and neurobiological mechanisms. In this Panel Workshop, our three speakers will share cutting-edge findings that demonstrate how placebo effects operate through a variety of mechanisms including conditioning effects, social learning, and via ‘mindsets’ about the body and its capacity to heal. Our speakers will also highlight how placebo effects may change with age, sharing novel data from child and adult samples. Finally, our speakers will discuss why demystifying placebo mechanisms is critical to effectively and ethically leveraging placebo effects in clinical care across the lifespan.

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Leveraging Mindsets to Ethically Harness the Placebo Effect in Adults and Youth

Dr. Lauren Heathcote will argue that the power of the placebo does not reside in the sham treatment itself; rather, it comes from the psychosocial forces that surround the patient and the treatment. To that end, she will share new data suggesting that ‘mindsets’ are key mechanisms involved in the placebo effect in both adults and in youth. In a series of new cross-sectional studies, she will show that mindsets about the body and its capacity to heal are uniquely associated with pain outcomes in over 200 children and adults with chronic pain as well as childhood cancer survivors. She will also share the findings of a new experimental study with 800 adults receiving the covid vaccine, in which a brief body mindset intervention changed the report and experience of aches and pains and other flu-like symptoms; this mindset intervention is now being applied to youth undergoing painful surgical procedures.  

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Age, Sex and Race Effects on Placebo Analgesia: Results from a Large Cohort Study in Chronic Pain and Healthy Participants

This talk will present recent results with sex, race, and age being explored in a large cross-sectional study enrolling over 800 chronic pain patients and matched controls. Colloca and her team were the first to demonstrate influences of race/ethnicity on placebo hypoalgesia. Racial effects on placebo hypoalgesia are small and negligible. AfroAmerican/Black participants have lower placebo effects which are mediated by conditioning strength. Concordance between the experimenter and participant race induced greater placebo hypoalgesia in chronic pain patients hinting to the fact that disparities and racial biases may play a role. Independently of gonadal hormone levels, women show stronger placebo effects than men. There were also statistically significant sex differences for the conditioning strength and reinforced expectations whereby reinforced expectations mediated the sex-related larger placebo effects in women. Finally, distinct adulthood ages contribute to larger placebo effects in chronic pain patients with placebo effects (unpublished data). Overall, these findings are new, informative for clinical practice and trials and new age-related research approaches.

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Pain, Placebo, and Positive Feedback Loops

Dr. Tor Wager will share how social influence and conditioned cue effects act as key mechanisms driving placebo effects in adults, and how these could be ethically leveraged to enhance placebo effects in clinical care.  He will argue that these mechanisms can create the conditions for positive feedback loops between beliefs and the experience of pain and other symptoms. Targeting these feedback loops can result in effective psychological treatments for chronic pain.  

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How Can We Mitigate the Negative Effects of Information about Side-effects?

Information about side effects can create negative expectations in patients that cause a nocebo effect. This negatively impacts on treatment adherence, well-being and health care utilization.  Research has begun to examine how to reduce this nocebo response. One method is by framing information to balance the presentation of adverse effects with the expected benefits from the treatment. Another approach we have tested is to give patients information about the nocebo effect itself and how it works. This involves an explanation about how discussing side effects can by itself cause people to experience symptoms. We have found that this method can reduce the nocebo effect following expectations of symptoms from an environmental stimulus and in participants taking a medicine, compared to standard information control groups. Another important factor is media reporting of side effects. Research has shown television and newspaper reports can increase side effect reporting and intensify somatic experiences. These cases have highlighted the need for media guidelines to reduce the social transmission of nocebo effects.      

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Nocebo Effects in the Covid-19 Area: How does Information about Side-effects Influence Actual Side-effects and How can we Mitigate these Effects? Finding Across Three Continents

It is well-know that information about side-effects may lead to side-effects. Yet, less is known about the general public’s knowledge of this phenomenon and how that may decrease or increase the negative effects. The pandemic has allowed for a detailed and world-wide comparisons of how expectations of side effects influence actual side effects following COVID-19 and Influenza vaccines, highlighting cultural differences and psycho-neuro-biological interactions. Various strategies to mitigate the negative effects of side-effect information have started to emerge, which has important implications for patients, clinicians, and health authorities.
In this panel workshop, Lene Vase will present a recent survey across US and Europe specifying the general public’s understanding of how communication with health care professionals may influence side-effects – illustrating important cultural differences in people’s preference for how information concerning side-effects should be presented. Luana Colloca will show that expectations of side-effects towards COVID-19 and Influenza vaccines may influence actual side-effects across US, Europe and New Zealand and illustrate how this phenomenon relates to the psycho-neuro-biological findings on nocebo effects in general. Keith Petrie will provide an overview of the multiple factors that may influence side-effect development and discuss novel ways of mitigating these effects in ethical appropriate ways.

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