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This is important history for all pain specialists to know and never forget.... Entire academic careers were built and advanced on this misrepresentation and confusion of placebo versus active comparators in meta-analysis of pain treatment. It is the genesis of GIGO science and Mu-Shu Medicine in our field.
"The initial travesty of misinterpretation of interventional
pain management trials originated with Chou
and Huffman (121). These guidelines were basically prepared
by Huffman, a non-physician, with assistance and
supervision from Chou. Since then, multiple budding
evidence-based medicine specialists (122,126,147-149)
have expanded the philosophy, accepted by many others
with political aspirations and confluence of interest,
of converting active control trials into placebo control
trials. Fundamentally, they have developed an alternate
universe of misinterpretation without understanding
the effect of placebo and nocebo, active placebo, inappropriateness
of conversion of active trials to placebo
trials, and the specific effects of healing rituals, doctor/
patient relationship, and meaning response instead of
response to placebo."
Abstract
Researchers have been aware of placebo and nocebo effects for decades, even though misunderstandings and misgivings continue to be seen in scientific studies. In simplistic terms, placebo and nocebo had been understood to indicate improving or worsening of symptoms that occur during treatment with placebo/nocebo drugs or modalities. However, research has demonstrated that such terminology does not necessarily reflect “true” placebo effect or nocebo response. These effects are based on numerous factors, including natural course of a disease, spontaneous remission, regression to the mean, and a multitude of other conceptual, explanatory, and moral challenges. In modern clinical research, a neutral substance called placebo has been mainly used as a comparison factor rather than being studied itself, while the nocebo response has only been minimally studied.
A major misconception involves active placebo, a concept that has been extended beyond the administration of inert substances. The definition of active placebo of an active agent given to a patient, even though the pharmacologic action of the active agent is not known to be beneficial, has been converted to conveniently change many of the treatments which are effective on their own to be defined as placebos, often leading to conclusions that none of the interventions are effective.
This review focuses on a multitude of controversies surrounding placebo and nocebo phenomena in research and clinical applications. The discussion includes a focus on unsolved, forgotten, and ignored features of placebo responses in medicine, and provides an appropriate understanding of placebo and nocebo phenomena in interventional pain management. To that effect, this review also describes therapeutic placebos, research with open placebos, and improvements in understanding clinical applications of present interventional pain management research.
Keywords: Placebo effect, nocebo response, placebo analgesia, interventional techniques, active control trials, active placebos
See also:
Psuedo-medicine approved for use in Oregon
http://www.painphysicianjournal.com/current/pdf?article=NDUwMw==
"The initial travesty of misinterpretation of interventional
pain management trials originated with Chou
and Huffman (121). These guidelines were basically prepared
by Huffman, a non-physician, with assistance and
supervision from Chou. Since then, multiple budding
evidence-based medicine specialists (122,126,147-149)
have expanded the philosophy, accepted by many others
with political aspirations and confluence of interest,
of converting active control trials into placebo control
trials. Fundamentally, they have developed an alternate
universe of misinterpretation without understanding
the effect of placebo and nocebo, active placebo, inappropriateness
of conversion of active trials to placebo
trials, and the specific effects of healing rituals, doctor/
patient relationship, and meaning response instead of
response to placebo."
Abstract
- 2017;20;363-386Therapeutic Role of Placebo: Evolution of a New Paradigm in Understanding Research and Clinical Practice
Comprehensive Review
Laxmaiah Manchikanti, MD, Mark V. Boswell, MD, PhD, Alan D. Kaye, MD, PhD, Standiford Helm II, MD, and Joshua A. Hirsch, MD.
Researchers have been aware of placebo and nocebo effects for decades, even though misunderstandings and misgivings continue to be seen in scientific studies. In simplistic terms, placebo and nocebo had been understood to indicate improving or worsening of symptoms that occur during treatment with placebo/nocebo drugs or modalities. However, research has demonstrated that such terminology does not necessarily reflect “true” placebo effect or nocebo response. These effects are based on numerous factors, including natural course of a disease, spontaneous remission, regression to the mean, and a multitude of other conceptual, explanatory, and moral challenges. In modern clinical research, a neutral substance called placebo has been mainly used as a comparison factor rather than being studied itself, while the nocebo response has only been minimally studied.
A major misconception involves active placebo, a concept that has been extended beyond the administration of inert substances. The definition of active placebo of an active agent given to a patient, even though the pharmacologic action of the active agent is not known to be beneficial, has been converted to conveniently change many of the treatments which are effective on their own to be defined as placebos, often leading to conclusions that none of the interventions are effective.
This review focuses on a multitude of controversies surrounding placebo and nocebo phenomena in research and clinical applications. The discussion includes a focus on unsolved, forgotten, and ignored features of placebo responses in medicine, and provides an appropriate understanding of placebo and nocebo phenomena in interventional pain management. To that effect, this review also describes therapeutic placebos, research with open placebos, and improvements in understanding clinical applications of present interventional pain management research.
Keywords: Placebo effect, nocebo response, placebo analgesia, interventional techniques, active control trials, active placebos
See also:
Psuedo-medicine approved for use in Oregon
http://www.painphysicianjournal.com/current/pdf?article=NDUwMw==
