Placebo ethics.
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01-01-2013, 09:04 PM
Placebo ethics.
Hey Everyone,

I should preface this topic with a little background information. Since I am new to this forum I will re-introduce myself. I am a PhD student in applied Biopsychology. My area of study upon entering the program was pain, primarily. The topic of pain, and my adviser at the time, led me interestingly to the study of placebo's, placebo effects and its evil twin nocebo's and nocebo effects.

A question I often get is why study placebo effects? Because placebo effects are real physiological responses to a wide range of conditions, such as Parkinson's disease, pain, irritable bowel syndrome, surgical interventions, depression, well you get the idea. Many, if not most, people seem to think that placebo effects are transient events largely experienced by gullible individuals with little to no actual medical value. I mean who but the gullible would be fooled by a cornstarch pill, right? Wrong. Everyone under the right circumstance, a complete discussion of which would be too lengthy for this point, will positively respond to a placebo. The effects of which can be minutes, to weeks, to years in some instances. Placebo's are not just inert corn starch pills either. A placebo can as mundane as a verbal suggestion or as active as an antibiotic. You may wonder how an antibiotic could be a placebo. The answer is when an active substance is given for a condition when said substance has no treatment efficacy. In other words, giving an antibiotic prescription for a viral infection, for example. This happens more often than one might think and is often done to pacify a difficult or insistent patient. Not everyone likes being told they have the flu and to go home and rest.

Patient pacification aside, there are real potential benefits to giving placebo's in some cases. One example might be as an adjunctive therapy to chronic pain. Tolerance to opioids develops fairly quickly on average and how best to manage chronic pain is a significant medical question, not only for the practitioner but for the patient as well. Any additional tool in the arsenal of chronic pain treatment can certainly be construed as a positive thing. That said, I want to be clear. Placebo's and their effects are not curative. Placebo's work by engaging the natural systems of the body. In the case of pain, endogenous opioids (endorphins) and other systems are engaged, in other cases the immune system can be engaged or disengaged. So placebo's will not help cure cancer, for example, but they could be employed to help manage the symptoms of cancer such as pain and nausea.

I mentioned earlier that everyone, in the right circumstance, will respond to a placebo (either active or inert). What is not understood is what circumstance will trigger a placebo effect. For example, a person may experience a placebo effect for depression but not for pain or a person may experience a placebo effect for a shot but not for a pill. These questions and the questions of exactly what biological mechanisms are being engaged is what my research tries to examine. What I am not researching at the moment are the ethics of employing placebo's in a medical setting.

Let's take a leap of imagination and assume that questions of who may respond to which type of placebo have been answered and that we more fully understand the underlying biological mechanisms. Given that assumption, I am curious to know whether you think it is ethical to give placebo's as an adjunctive therapy in a legitimate medical setting? Keeping in mind that generally speaking, though not always, placebo's involve an element of deception. I have no fixed answer in mind, just hoping to generate some conversation on the topic and naturally I haven't thoroughly covered all the complexities of this topic.
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01-01-2013, 09:43 PM
RE: Placebo ethics.
Nice post on a very interesting subject.

I, myself, have suffered from lower back pain (incurred from a car accident and subsequent spinal fusion going back 20 years ago) for most of my adult life and have taken so many painkillers over the years that I get an annual liver function test to make sure I have no adverse effects from all of them (paracetamol and codeine mainly). I have tried everything in the known world to try and lessen the pain I get now (which is mostly from the scar issue and the bone donor site in my hip).

I would be very interested in the research of placebo effects. So tell me more.... Consider Smile

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01-01-2013, 10:26 PM
RE: Placebo ethics.
I assume this is only about pain, or perhaps lessening of cold or flu symptoms - not treatment for jaundice or a broken jaw - right?

You are investigating a psychological method of controlling pain?
Okay, the placebo works for some patients. Figure out the mechanism of the suggestion, or the pathway whereby the mind persuades the brain to stop complaining about the pain, or whatever does happen in the most successful cases of placebo effect.
Then teach patients how to access these mechanisms, or practice these auto-suggestions directly, and bypass the starch pill.
No deception, no ethical dilemma, and a huge help to chronic pain sufferers - perhaps including the ones who don't get such positive results with a placebo; perhaps it's the deception they're resisting, not the psychological control.

My suggestion for a place to start would be any chronic pain support group that's working well. The participants are open to new regimens and methods, have already begun to practice meditation, Yoga, visualization, etc, and are in the habit of talking about their symptoms and their coping strategies, so they would be be both receptive to and responsive in a new study.

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01-01-2013, 10:29 PM
RE: Placebo ethics.
(01-01-2013 09:43 PM)aurora Wrote:  Nice post on a very interesting subject.

I, myself, have suffered from lower back pain (incurred from a car accident and subsequent spinal fusion going back 20 years ago) for most of my adult life and have taken so many painkillers over the years that I get an annual liver function test to make sure I have no adverse effects from all of them (paracetamol and codeine mainly). I have tried everything in the known world to try and lessen the pain I get now (which is mostly from the scar issue and the bone donor site in my hip).

I would be very interested in the research of placebo effects. So tell me more.... Consider Smile
Thanks aurora!

Sorry to hear about your chronic low back pain. Though I don't currently have chronic pain, I have been exposed to a large number of chronic pain patients and you have my deepest empathy.

There is a drug called proglumide that seems to me would be a huge benefit to chronic pain patients. It is primarily used as a research tool and is not dispensed as an active medication, at least in the US, and I don't know why. It is technically not a pain reliever, it is a non-selective CCK antagonist. CCK (Cholecystokinin) is a neuropeptide found in the gut and the brain. In the brain it is intimately involved in the anxiety response but more importantly it is an opioid antagonist. Since pain has a vital evolutionary function there are two systems typically involved. Say, for example, you are in the jungle and a large animal attacks you causing significant injury but you manage to get away. One of the systems that engaged to allow you to get away instead of succumbing to the excruciating pain is your endogenous opioid (endorphin) system. However, this system is designed to be only temporary because you need the pain that tells you to rest and recuperate. In order to do that your body has to have a way of shutting down the endorphins and that system is CCK. These systems though were not designed to handle chronic pain and that is where the problem begins.

Your endorphin system is the system that opioids target and subsequently provide pain relief by mimicking your natural pain relieving system. If you add a drug that blocks CCK then you are in effect increasing the benefit of the opioids you have been prescribed. Proglumide is synergistic with opioid administration and has even been reported to reduce opioid tolerance, which is a huge concern with chronic pain management. Let me be clear, I am not advocating that you look for proglumide, but you might talk to your physician. That said, I have spoken to a number of pain doctors about proglumide and they were not aware of it and I haven't been able to discern why that might be. Proglumide is not a new compound.

At any rate, I would also not recommend that you or anyone go to your physician and ask for a placebo. It doesn't quite work that way. There needs to be an element of expectation that what you are taking would work which is where the deception part comes in. If one was to ask for a placebo, then you are asking for an inert pill and you KNOW it is inert and the mechanisms would not be engaged. I am not suggesting this is what you were thinking, however. So, if you have a specific question on how a placebo might work in a given situation I could perhaps provide more information.
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01-01-2013, 10:52 PM
RE: Placebo ethics.
(01-01-2013 10:26 PM)Peterkin Wrote:  I assume this is only about pain, or perhaps lessening of cold or flu symptoms - not treatment for jaundice or a broken jaw - right?

Not exactly, pain is what I primarily study and is the vehicle I use to induce placebo and nocebo effects in subjects but placebo's have been demonstrated to work very well for depression. In fact, some studies have suggested that up to 75 percent of response rates in clinical trials for anti-depressants are in fact placebo responses. There has been a number of studies done on placebo responses in Parkinson's disease. In short, no its not just about pain.

Quote:You are investigating a psychological method of controlling pain?

I would say augmenting pain relief. I don't think placebo's are a replacement for anything, but something that could be used to assist current treatments.

Quote:Okay, the placebo works for some patients. Figure out the mechanism of the suggestion, or the pathway whereby the mind persuades the brain to stop complaining about the pain, or whatever does happen in the most successful cases of placebo effect.
Then teach patients how to access these mechanisms, or practice these auto-suggestions directly, and bypass the starch pill.
No deception, no ethical dilemma, and a huge help to chronic pain sufferers - perhaps including the ones who don't get such positive results with a placebo; perhaps it's the deception they're resisting, not the psychological control.

Understanding the pathways and mechanics involved are of critical importance but we really are in an infancy stage. Placebo research has only really been taken seriously for the past 15 years or so. Before that placebo's were considered sort of taboo or some sort of woo. It was all just thought to be in the "mind" and therefore not a serious medical question. We know better now, but it still meets some resistance.

Even if or when we know the mechanism does not necessarily mean that we can effective teach people to access them. Some systems are beyond access. That said, there are indeed effective cognitive management techniques, some of which you mention (relaxation, meditation, visualization) to help people better control pain but it doesn't work for everyone.
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01-01-2013, 10:59 PM
RE: Placebo ethics.
(01-01-2013 10:29 PM)BioPsychMS Wrote:  
(01-01-2013 09:43 PM)aurora Wrote:  Nice post on a very interesting subject.

I, myself, have suffered from lower back pain (incurred from a car accident and subsequent spinal fusion going back 20 years ago) for most of my adult life and have taken so many painkillers over the years that I get an annual liver function test to make sure I have no adverse effects from all of them (paracetamol and codeine mainly). I have tried everything in the known world to try and lessen the pain I get now (which is mostly from the scar issue and the bone donor site in my hip).

I would be very interested in the research of placebo effects. So tell me more.... Consider Smile
Thanks aurora!

Sorry to hear about your chronic low back pain. Though I don't currently have chronic pain, I have been exposed to a large number of chronic pain patients and you have my deepest empathy.

There is a drug called proglumide that seems to me would be a huge benefit to chronic pain patients. It is primarily used as a research tool and is not dispensed as an active medication, at least in the US, and I don't know why. It is technically not a pain reliever, it is a non-selective CCK antagonist. CCK (Cholecystokinin) is a neuropeptide found in the gut and the brain. In the brain it is intimately involved in the anxiety response but more importantly it is an opioid antagonist. Since pain has a vital evolutionary function there are two systems typically involved. Say, for example, you are in the jungle and a large animal attacks you causing significant injury but you manage to get away. One of the systems that engaged to allow you to get away instead of succumbing to the excruciating pain is your endogenous opioid (endorphin) system. However, this system is designed to be only temporary because you need the pain that tells you to rest and recuperate. In order to do that your body has to have a way of shutting down the endorphins and that system is CCK. These systems though were not designed to handle chronic pain and that is where the problem begins.

Your endorphin system is the system that opioids target and subsequently provide pain relief by mimicking your natural pain relieving system. If you add a drug that blocks CCK then you are in effect increasing the benefit of the opioids you have been prescribed. Proglumide is synergistic with opioid administration and has even been reported to reduce opioid tolerance, which is a huge concern with chronic pain management. Let me be clear, I am not advocating that you look for proglumide, but you might talk to your physician. That said, I have spoken to a number of pain doctors about proglumide and they were not aware of it and I haven't been able to discern why that might be. Proglumide is not a new compound.

At any rate, I would also not recommend that you or anyone go to your physician and ask for a placebo. It doesn't quite work that way. There needs to be an element of expectation that what you are taking would work which is where the deception part comes in. If one was to ask for a placebo, then you are asking for an inert pill and you KNOW it is inert and the mechanisms would not be engaged. I am not suggesting this is what you were thinking, however. So, if you have a specific question on how a placebo might work in a given situation I could perhaps provide more information.
Thank you for your response, BioPsychMS Smile
I will look into this further.

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01-01-2013, 11:00 PM
RE: Placebo ethics.
As someone who dealt with a tremendous amount of post-op pain partly due to nerve damage, I would have gladly accepted anything that worked. About the only thing that did help was whatever would knock me out so I could sleep through it, but I wanted something that worked and allowed me to function. At this point I deal with the residual pain (three years later) because it seems I have no options. Doctors are afraid I will become an addict so short of going on the black market for meds...I just have to suck it up. I wouldn't care if pain relief was real or placebo...I would just like something that was effective...I don't care if someone has to stick pins in a Voodoo doll to do it.

Good luck with the research and thanks...pain management is something that really needs to improve.

See here they are, the bruises, some were self-inflicted and some showed up along the way. - JF
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01-01-2013, 11:26 PM
RE: Placebo ethics.
(01-01-2013 11:00 PM)Anjele Wrote:  As someone who dealt with a tremendous amount of post-op pain partly due to nerve damage, I would have gladly accepted anything that worked. About the only thing that did help was whatever would knock me out so I could sleep through it, but I wanted something that worked and allowed me to function. At this point I deal with the residual pain (three years later) because it seems I have no options. Doctors are afraid I will become an addict so short of going on the black market for meds...I just have to suck it up. I wouldn't care if pain relief was real or placebo...I would just like something that was effective...I don't care if someone has to stick pins in a Voodoo doll to do it.

Good luck with the research and thanks...pain management is something that really needs to improve.
Thanks yourself. You bring up an interesting issue and that is the pain caused by nerve damage. It is quite distinct from other types of pain and has not only different perceptual qualities (burning sensation instead of aching, throbbing or sharp) but doesn't respond well to opioids. I haven't yet investigated if there is a differential placebo response to different types of pain. We can pretty well articulate how placebo's might work in the endogenous opioid system but the burning sensation often accompanying nerve damage is less understood. Heck, to be honest we don't really have a very good grasp on pain as a whole as any chronic pain sufferer can attest. If we did have a better understanding of how pain was perceived you would not be suffering three years post surgery.
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02-01-2013, 12:12 AM
RE: Placebo ethics.
(01-01-2013 10:59 PM)aurora Wrote:  
(01-01-2013 10:29 PM)BioPsychMS Wrote:  Thanks aurora!

Sorry to hear about your chronic low back pain. Though I don't currently have chronic pain, I have been exposed to a large number of chronic pain patients and you have my deepest empathy.

There is a drug called proglumide that seems to me would be a huge benefit to chronic pain patients. It is primarily used as a research tool and is not dispensed as an active medication, at least in the US, and I don't know why. It is technically not a pain reliever, it is a non-selective CCK antagonist. CCK (Cholecystokinin) is a neuropeptide found in the gut and the brain. In the brain it is intimately involved in the anxiety response but more importantly it is an opioid antagonist. Since pain has a vital evolutionary function there are two systems typically involved. Say, for example, you are in the jungle and a large animal attacks you causing significant injury but you manage to get away. One of the systems that engaged to allow you to get away instead of succumbing to the excruciating pain is your endogenous opioid (endorphin) system. However, this system is designed to be only temporary because you need the pain that tells you to rest and recuperate. In order to do that your body has to have a way of shutting down the endorphins and that system is CCK. These systems though were not designed to handle chronic pain and that is where the problem begins.

Your endorphin system is the system that opioids target and subsequently provide pain relief by mimicking your natural pain relieving system. If you add a drug that blocks CCK then you are in effect increasing the benefit of the opioids you have been prescribed. Proglumide is synergistic with opioid administration and has even been reported to reduce opioid tolerance, which is a huge concern with chronic pain management. Let me be clear, I am not advocating that you look for proglumide, but you might talk to your physician. That said, I have spoken to a number of pain doctors about proglumide and they were not aware of it and I haven't been able to discern why that might be. Proglumide is not a new compound.

At any rate, I would also not recommend that you or anyone go to your physician and ask for a placebo. It doesn't quite work that way. There needs to be an element of expectation that what you are taking would work which is where the deception part comes in. If one was to ask for a placebo, then you are asking for an inert pill and you KNOW it is inert and the mechanisms would not be engaged. I am not suggesting this is what you were thinking, however. So, if you have a specific question on how a placebo might work in a given situation I could perhaps provide more information.
Thank you for your response, BioPsychMS Smile
I will look into this further.
Your welcome. If you need some information about research articles referencing proglumide Dr. Fabrizio Benedetti has done quite a lot of research using the compound and is one of the world's leading experts on the neurobiology of the placebo response.
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02-01-2013, 12:19 AM
RE: Placebo ethics.
Handing out "placebo antibiotics" is one of the reasons "super-bugs" are growing out, and resistance to some of the usual ones has increased. It's wrong, and in general is bad for the world. I say total honesty is best.

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