Sunday, April 5, 2015

Placebo_Effect_Max_Strength_packageThe Placebo Effect by Jeffrey Dach MD

link to article
 
Forty three years ago, I was in medical school at the University of Illinois in Chicago.  The Chief of Medicine offered some useful advice about dispensing medication.  He suggested we provide the patient with a few encouraging words while writing the prescription. 

This is called the Placebo Effect or the power of suggestion on the mind. By merely suggesting that something will work, it does.  Doctors use the placebo effect in many ways, some intentional, and some unintentional.

Placebo Effect Thought Effective and is Commonly Used in Medicine

Studies show that the placebo effect is important in various disease treatments.  Dr. Benson says in Annual Review of Medicine 1996: "The placebo effect yields beneficial clinical results in 60-90% of diseases that include angina pectoris, bronchial asthma, herpes simplex, and duodenal ulcer." (9)  Dr. Eccles says in Current Allergy and Asthma 2007:  "The placebo response is the largest component of any allergy treatment." (16)

Header Image: “Placebo Pills” product design courtesy of Darren Cullen.


Prozac_Pills_Placebo_EffectSSRI Drugs No Better Than Placebo

An interesting example can be found with the SSRI  antidepressant drugs.  Dr. Khan reviewed clinical trial data submitted to the FDA for nine SSRI antidepressant drugs approved by the FDA between 1985 and 2000. This included 10,030 depressed patients in 52 clinical trials.  The Placebo (inert dummy pill) worked better than the SSRI antidepressant pill in more than half the studies.  This is astounding information showing the power of the Placebo, or the lack of effectiveness of the SSRI antidepressant drugs.(1)(2)  See my previous article on this: Antidepressants No Better Than Placebo.

Left Image Prozac courtesy of Just Health
MRI_Knee_Arthroscopy_PlaceboKnee Arthroscopy 

No Better than Placebo for Osteoarthritis

Another placebo effect was brought to public attention in the New England Journal of Medicine showing that arthroscopic knee surgery for osteoarthritis is no better than a placebo.  In its time, half million procedures a year were being done with no more effectiveness than placebo, until new  studies halted the practice.

When studied properly with  placebo controlled methods,  arthroscopic surgery for osteoarthritis is found to be no better than a sham operation.(3)  This result isn't surprising.  Arthroscopic surgery simply cannot  compete with total knee replacement, since lost cartilage cannot be repaired or "healed" with an arthroscope.   Left Image Knee MRI courtesy of American Radiology Services.

Regeneration of cartilage requires a healing process over time with stem cell injections, hormone treatments, and nutrients to assist  regeneration of the cartilage layer at the joint space.  In some cases, avoiding Nightshade Foods seems to help. Local application of low level Lasers and electro-magnet stimulation stimulate joint healing.  As a last resort, operation with total knee  replacement is offered.

optiray.gif_IV_Contrast_ImagingReverse Placebo Effect

The Power of the "Nocebo"

The Reverse Placebo effect, called the  Nocebo Phenomena in Medicine has also been studied.  What is the Nocebo effect? The doctor explains to the patient the adverse side effects of treatment, and then the adverse effect happens. The mental suggestion of an adverse outcome increases its chance of happening.  Left Image IV contrast courtesy of CT Scan Info.

Adverse Outcome from IV Contrast Infusion

In the olden days, 42 years ago, I was in training to be a radiologist.  Part of my job was to inject Intravenous contrast material which occasionally caused allergic reactions, hives, wheezing etc.  and rarely resulted in death from respiratory failure from anaphylacric shock and laryngeal spasm.  We had a crash cart handy stocked with ampules of epinephrine in case of this event.
Before injecting the IV contrast, my colleagues and I were obligated to have the patient sign a consent form.  We were supposed to inform the patient of the possible adverse side effects of IV contrast.   In actual practice we avoided mentioning the possiblility of a  horrendous outcome, because the mere suggestion might increase the chance of it happening.  We were worried about the "Nocebo Effect".  Fortunately, the problematic older contrast agents were soon replaced with safer agents associated with fewer side effects. (4)

The Power of Belief

My conclusion is that efficacy of a pill or procedure is influenced by belief and the power of suggestion.  But then again, this is true only if you believe it.

Jeffrey Dach MD

References and Links:
Read about: Placebo_the_forgotten_drug_Boström_ 1997
Read a Comprehensive Review: Comprehensive_Review_Placebo_Effect_Donald_Price_2008

Read more on the placebo effect at this link.
Read about the Nocebo Effect here:
Nocebo Phenomena in Medicine Winfried Häuser 2012
More on the placebo effect by Stephen Goldberg and MedMAster

Link to this article: http://wp.me/p3gFbV-2dP

Jeffrey Dach MD
7450 Griffin Road Suite 190
Davie, Fl 33314
954-792-4663

References:
(1) http://query.nytimes.com/gst/fullpage.html?sec=health&res=9B0CE2DF1F3FF936A15755C0A9649C8B63
Can the Placebo Treat Depression? That Depends By RICHARD A. FRIEDMAN New York Times June 25, 2002
(2) http://www.ncbi.nlm.nih.gov/pubmed/11799341
Severity of depression and response to antidepressants and placebo: an analysis of the Food and Drug Administration database. Khan A, Leventhal RM, Khan SR, Brown WA., Journal of Clinical Psychopharmacology, 22, 40-45. Northwest Clinical Research Center, Bellevue,
(3) http://content.nejm.org/cgi/content/abstract/347/2/81
A Controlled Trial of Arthroscopic Surgery for Osteoarthritis of the Knee J. Bruce Moseley, M.D., Kimberly O’Malley, Ph.D., Nancy J. Petersen, Ph.D., Terri J. Menke, Ph.D., Baruch A. Brody, Ph.D., David H. Kuykendall, Ph.D., John C. Hollingsworth, Dr.P.H., Carol M. Ashton, M.D., M.P.H., and Nelda P. Wray, M.D., M.P.H. NEJM V347:81-88 July 11, 2002 No.2
(4) http://www.ncbi.nlm.nih.gov/pubmed/16454540
Current understanding of contrast media reactions and implications for clinical management. Drug Saf 2006;29(2):133-41.
5)http://www.ncbi.nlm.nih.gov/pubmed/20100289
Geriatr Gerontol Int. 2010 Apr;10(2):131-7.
Would the elderly be better off if they were given more placebos?
Cherniack EP.     TheGeriatrics Institute, University of Miami Miller School of Medicine, Division ofGeriatrics andGerontology, and theGeriatrics and Extended Care Service and Geriatric Research Education, and Clinical Center of Miami Veterans Affairs Medical Center, Miami, Florida 33125, USA.Placebos are useful in the medical care of the elderly, although the exact definition of a “placebo” or “placebo effect” is difficult to define precisely. They have an important role as control treatments in research trials, but a non-specific “placebo effect” may also be beneficial part of many physician-patient interactions. Physicians also give them deliberately according to several studies worldwide to satisfy patient demands or because they believe in a “placebo effect” among other reasons. A significant placebo effect has been observed among older patients in clinical trials of antidepressants (12-15%), and in treatments of Parkinson’s disease (16%). Placebos activate serotonergic pathways in the brain used by antidepressants. In Parkinson’s disease, the administration of a placebo stimulates dopamine release in the dorsal (resulting in motor effects) and ventral striatum (which influences expectation of reward). Much of our understanding of the placebo effect comes from studies of placebo analgesia which is influenced by conditioning, expectation, meaning and context of the treatment for the patient, and patient-physician interaction. It is anatomically medicated by brain opioid pathways. Response to “sham” acupuncture in osteoarthritis may be an example of its use in the elderly. Placebos have often been considered a deception and thus unethical. On the other hand, some physicians and ethicists have suggested conditions for appropriate uses for placebos. A placebo might offer the theoretical advantage of an inexpensive treatment that would not cause adverse drug reactions or interactions with other medications, potentially avoiding complications of polypharmacy.
6) http://www.ncbi.nlm.nih.gov/pubmed/20638817
PatientEducCouns. 2010 Sep;80(3):293-9.The silent healer: the role of communication in placebo effects.
Bensing JM1, Verheul W.     1Faculty of Social and Behavioural Science, Netherlands Institute for Health Services Research, Utrecht University, The Netherlands.
Placebo effects have an ambiguous reputation, as they are associated with sham treatment and deceit on the one hand and as interesting phenomena, which might be clinically relevant on the other. The goal of this paper is to demonstrate that placebo effects are relevant and can be used as an effective part of many treatments by using communication targeting placebo effect mechanisms. We examined the history of placebos and the placebo effect, addressing common misconceptions and disentangling ambiguities. We then reviewed whether the placebo effect can be robustly shown in the current literature, and zoomed in on the plausible mechanisms (conditioning, expectancies and affect manipulation) through which the placebo effect might be produced. Observing the link with the doctor-patient communication literature, and pleading for a better integration of the two research traditions we conclude by setting out a research agenda for testing the role of communication in placebo effects.
7) Placebo_the_forgotten_drug_Boström_ 1997
Scand J Work Environ Health. 1997;23 Suppl 3:53-7.
Placebo–the forgotten drug.Boström H.The placebo effect is seen in patients who have been the target of intervention believed to lack specific action. This effect seems to be an important, and possibly the only, contribution to the positive effect of alternative medicine sometimes reported. The risks involved in the uncritical utilization of the placebo effect are, however, great and must be carefully considered. Most of the information available on this effect has been obtained from double-blind studies in connection with the introduction of new drugs. Depending on the kind of effect that is expected, improvements of up to 30% or more can be noted. Many attempts have been made to explain the nature of the placebo effect. Thus it has been suggested that a placebo acts by decreasing anxiety. Another explanation is that a placebo acts by meeting the expectations of the patient. It has also been proposed that the human placebo response has characteristics of a conditioned response.
8) http://www.ncbi.nlm.nih.gov/pubmed/17550344
Annu Rev Psychol. 2008;59:565-90.
A comprehensive review of the placebo effect: recent advances and current thought. Price DD1, Finniss DG, Benedetti F.
Our understanding and conceptualization of the placebo effect has shifted in emphasis from a focus on the inert content of a physical placebo agent to the overall simulation of a therapeutic intervention. Research has identified many types of placebo responses driven by different mechanisms depending on the particular context wherein the placebo is given. Some placebo responses, such as analgesia, are initiated and maintained by expectations of symptom change and changes in motivation/emotions. Placebo factors have neurobiological underpinnings and actual effects on the brain and body. They are not just response biases. Other placebo responses result from less conscious processes, such as classical conditioning in the case of immune, hormonal, and respiratory functions. The demonstration of the involvement of placebo mechanisms in clinical trials and routine clinical practice has highlighted interesting considerations for clinical trial design and opened up opportunities for ethical enhancement of these mechanisms in clinical practice.
9) http://www.ncbi.nlm.nih.gov/pubmed/8712773
Annu Rev Med. 1996;47:193-9.
Harnessing the power of the placebo effect and renaming it “remembered wellness”.  Benson H1, Friedman R.The placebo effect yields beneficial clinical results in 60-90% of diseases that include angina pectoris, bronchial asthma, herpes simplex, and duodenal ulcer. Three components bring forth the placebo effect: (a) positive beliefs and expectations on the part of the patient; (b) positive beliefs and expectations on the part of the physician or health care professional; and (c) a good relationship between the two parties. Because of the heavily negative connotations of the very words “placebo effect, ” the term should be replaced by “remembered wellness.” Remembered wellness has been one of medicine’s most potent assets and it should not be belittled or ridiculed. Unlike most other treatments, it is safe and inexpensive and has withstood the test of time.
10) http://www.ncbi.nlm.nih.gov/pubmed/17437679
Curr Allergy Asthma Rep. 2007 May;7(2):100-4.
11) http://www.ncbi.nlm.nih.gov/pubmed/20100289
GeriatrGerontol Int. 2010 Apr;10(2):131-7.Would the elderly be better off if they were given more placebos?
Cherniack EP.  The Geriatrics Institute, University of Miami Miller School of Medicine, Division of Geriatrics and Gerontology, and the Geriatrics and Extended Care Service and Geriatric Research Education, and Clinical Center of Miami Veterans Affairs Medical Center, Miami, Florida 33125, USA.
Placebos are useful in the medical care of the elderly, although the exact definition of a “placebo” or “placebo effect” is difficult to define precisely. They have an important role as control treatments in research trials, but a non-specific “placebo effect” may also be beneficial part of many physician-patient interactions. Physicians also give them deliberately according to several studies worldwide to satisfy patient demands or because they believe in a “placebo effect” among other reasons. A significant placebo effect has been observed among older patients in clinical trials of antidepressants (12-15%), and in treatments of Parkinson’s disease (16%). Placebos activate serotonergic pathways in the brain used by antidepressants. In Parkinson’s disease, the administration of a placebo stimulates dopamine release in the dorsal (resulting in motor effects) and ventral striatum (which influences expectation of reward). Much of our understanding of the placebo effect comes from studies of placebo analgesia which is influenced by conditioning, expectation, meaning and context of the treatment for the patient, and patient-physician interaction. It is anatomically medicated by brain opioid pathways. Response to “sham” acupuncture in osteoarthritis may be an example of its use in the elderly. Placebos have often been considered a deception and thus unethical. On the other hand, some physicians and ethicists have suggested conditions for appropriate uses for placebos. A placebo might offer the theoretical advantage of an inexpensive treatment that would not cause adverse drug reactions or interactions with other medications, potentially avoiding complications of polypharmacy.
12) http://www.ncbi.nlm.nih.gov/pubmed/20638817
Patient Educ Couns. 2010 Sep;80(3):293-9.
The silent healer: the role of communication in placebo effects.
Bensing JM1, Verheul W. 1Faculty of Social and Behavioural Science, Netherlands Institute for Health Services Research, Utrecht University, The Netherlands.
Placebo effects have an ambiguous reputation, as they are associated with sham treatment and deceit on the one hand and as interesting phenomena, which might be clinically relevant on the other. The goal of this paper is to demonstrate that placebo effects are relevant and can be used as an effective part of many treatments by using communication targeting placebo effect mechanisms. We examined the history of placebos and the placebo effect, addressing common misconceptions and disentangling ambiguities. We then reviewed whether the placebo effect can be robustly shown in the current literature, and zoomed in on the plausible mechanisms (conditioning, expectancies and affect manipulation) through which the placebo effect might be produced. Observing the link with the doctor-patient communication literature, and pleading for a better integration of the two research traditions we conclude by setting out a research agenda for testing the role of communication in placebo effects.
13) Placebo_the_forgotten_drug_Boström_ 1997
Scand J Work Environ Health. 1997;23 Suppl 3:53-7.
Placebo–the forgotten drug.Boström H.
The placebo effect is seen in patients who have been the target of intervention believed to lack specific action. This effect seems to be an important, and possibly the only, contribution to the positive effect of alternative medicine sometimes reported. The risks involved in the uncritical utilization of the placebo effect are, however, great and must be carefully considered. Most of the information available on this effect has been obtained from double-blind studies in connection with the introduction of new drugs. Depending on the kind of effect that is expected, improvements of up to 30% or more can be noted. Many attempts have been made to explain the nature of the placebo effect. Thus it has been suggested that a placebo acts by decreasing anxiety. Another explanation is that a placebo acts by meeting the expectations of the patient. It has also been proposed that the human placebo response has characteristics of a conditioned response.
14) Comprehensive_Review_Placebo_Effect_Donald_Price_2008
http://www.ncbi.nlm.nih.gov/pubmed/17550344
Annu Rev Psychol. 2008;59:565-90.
A comprehensive review of the placebo effect: recent advances and current thought. Price DD1, Finniss DG, Benedetti F.
Our understanding and conceptualization of the placebo effect has shifted in emphasis from a focus on the inert content of a physical placebo agent to the overall simulation of a therapeutic intervention. Research has identified many types of placebo responses driven by different mechanisms depending on the particular context wherein the placebo is given. Some placebo responses, such as analgesia, are initiated and maintained by expectations of symptom change and changes in motivation/emotions. Placebo factors have neurobiological underpinnings and actual effects on the brain and body. They are not just response biases. Other placebo responses result from less conscious processes, such as classical conditioning in the case of immune, hormonal, and respiratory functions. The demonstration of the involvement of placebo mechanisms in clinical trials and routine clinical practice has highlighted interesting considerations for clinical trial design and opened up opportunities for ethical enhancement of these mechanisms in clinical practice.
15) http://www.ncbi.nlm.nih.gov/pubmed/8712773
Annu Rev Med. 1996;47:193-9.
Harnessing the power of the placebo effect and renaming it “remembered wellness”. Benson H1, Friedman R.
Abstract The placebo effect yields beneficial clinical results in 60-90% of diseases that include angina pectoris, bronchial asthma, herpes simplex, and duodenal ulcer. Three components bring forth the placebo effect: (a) positive beliefs and expectations on the part of the patient; (b) positive beliefs and expectations on the part of the physician or health care professional; and (c) a good relationship between the two parties. Because of the heavily negative connotations of the very words “placebo effect, ” the term should be replaced by “remembered wellness.” Remembered wellness has been one of medicine’s most potent assets and it should not be belittled or ridiculed. Unlike most other treatments, it is safe and inexpensive and has withstood the test of time.
16) http://www.ncbi.nlm.nih.gov/pubmed/17437679
Curr Allergy Asthma Rep. 2007 May;7(2):100-4.
The power of the placebo.Eccles R.
The placebo is much more than a control medicine in a clinical trial. The placebo response is the largest component of any allergy treatment and consists of two components: nonspecific effects (eg, natural recovery) and a “true placebo effect” that is the psychological therapeutic effect of the treatment. Belief in the beneficial nature of the treatment is a key component of the true placebo effect, and can be enhanced by factors such as interaction with the physician and the sensory impact of the treatment. Negative beliefs can generate a nocebo effect that may explain some psychogenic illnesses; this is the basis of much research in psychoneuroimmunology. An understanding of the placebo and nocebo effects is important for general allergy practice, and harnessing the power of the true placebo effect is a major challenge to modern medicine.
Reverse Placebo
17) http://www.ncbi.nlm.nih.gov/pubmed/14979775
http://stm.sciencemag.org/content/3/70/70ra14
http://www.sciencedaily.com/releases/2011/02/110226212356.htm
U. Bingel, V. Wanigasekera, K. Wiech, R. Ni Mhuircheartaigh, M. C. Lee, M. Ploner, I. Tracey. The Effect of Treatment Expectation on Drug Efficacy: Imaging the Analgesic Benefit of the Opioid Remifentanil. Science Translational Medicine, 2011; 3 (70)
18) http://www.ncbi.nlm.nih.gov/pubmed/14979775  Psychol Bull. 2004 Mar;130(2):324-40. The placebo effect: dissolving the expectancy versus conditioning debate.Stewart-Williams S1, Podd J.
The authors review the literature on the 2 main models of the placebo effect: expectancy theory and classical conditioning. A path is suggested to dissolving the theoretical impasse that has long plagued this issue. The key is to make a clear distinction between 2 questions: What factors shape placebo effects? and What learning mediates the placebo effect? The reviewed literature suggests that classical conditioning procedures are one shaping factor but that verbal information can also shape placebo effects. The literature also suggests that conditioning procedures and other sources of information sometimes shape conscious expectancies and that these expectancies mediate some placebo effects; however, in other cases conditioning procedures appear to shape placebo effects that are not mediated by conscious cognition.
19) Nocebo Phenomena in Medicine Winfried Häuser 2012
Häuser, Winfried, Ernil Hansen, and Paul Enck. "Nocebo phenomena in medicine: their relevance in everyday clinical practice." Deutsches Ärzteblatt International 109.26 (2012): 459.
Jeffrey Dach MD
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