Jul 19 2011

The Rise and Fall of Placebo Medicine

I am just getting back from The Amazing Meeting (TAM9 from Outer Space) – it was awesome but I had no time to blog while there. One of the events I participated in at TAM was a panel discussion on placebo medicine. We decided to focus on placebos for our science-based medicine panel because it increasingly looks like this will be the front lines for the next phase of the battle against pseudoscience in medicine.

I began the panel discussion by declaring victory, of a sorts. Over the last two decades the public and the scientific community have be told by CAM (complementary and alternative medicine) proponents that we were missing out on many potentially very useful and effective medical treatments simply because they are from other cultures or do not fit into the current scientific paradigm. “Give us the resources to research these diamonds in the rough,” they argued, “and we will give you new tools to promote health.”

Well – a couple a decades and a few billions of dollars worth of research later, and the CAM community has essentially nothing to show for it. The research is in: none of the major CAM modalities actually work. The evidence shows that homeopathy is just water, that acupuncture is no more effective than the kind attention of the practitioner, and that mystical life energies in fact do not exist.

A review of the research funded by the NCCAM, to the tune of over 2 billion dollars, found that all that research has not added one proven modality to the tools of health care. In defending this research the best the NCCAM can do is say that they have demonstrated that some popular herbs do not work, which reduced their market share a bit.

I agree that negative studies of existing treatments are valuable. But the point remains – the research has not gone exactly as the CAM proponents had predicted. Skeptics and more realistic scientists were not surprised that research into highly improbable therapies turned out to have a low probability of finding any of them effective.

What we are seeing now is a transition to the next strategy. Some CAM proponents (while they have generally not given up on their claims to efficacy) are shifting to the claim that while CAM modalities may not work any better than placebo, the placebo is a powerful treatment in itself. In essence they are advocating for placebo medicine via CAM modalities.

Further they are claiming that we should perhaps stop wasting our time doing efficacy trials (researching whether or not their treatments work – because they know how that turns out) and shift to asking how the placebo works and how it can be integrated into care.

I would argue that we already have a pretty good idea of how effective placebo medicine is. That’s what we had in the pre-scientific medicine era, when the average life expectancy was around 40.

To our delight, right before our panel discussion on placebos a major article on placebo effects was published in the New England Journal of Medicine. David Gorski has written an excellent review at Science-Based Medicine, and so I won’t repeat it here. I will just give you the punch line. Take a look at the following two tables.

In this study a real treatment for asthma was compared to two placebos, a placebo inhaler and sham acupuncture, and also to a no treatment group. The two charts above give the whole picture. The top figure shows the results for subjective outcomes – how the patient feels. The two placebo groups had an improvement over no treatment, and the real treatment (albuterol) had further improvement.

The table below shows the same comparison but for objective outcomes – measuring lung function. Here we see no change from no treatment to either placebo. And again we see an improvement in objective function with the real treatment.

Despite the spin of the authors – these results put placebo medicine into crystal clear perspective, and I think they are generalizable and consistent with other placebo studies. For objective physiological outcomes, there is no significant placebo effect. Placebos are no better than no treatment at all.

It is worth noting that there was still an improvement over baseline, just as there was in the no treatment group. This likely reflects non-specific effects and statistical effects, like regression to the mean. There are many potential effects lumped into the “the” placebo effect that gets measured in the placebo arm of a clinical trial. By comparing to the no treatment group what this study shows is that, for objective outcomes, the placebo effect is entirely made of these non-specific and statistical effects.

This further means that there is no expectation effect or mind-over-matter effect that has a measuring objective physiological effect.

For subjective outcomes (the patient reporting that they feel better) there is a large additional effect. This is likely comprised of reporter bias, expectation, and other psychological effects (which add to the non-specific and statistical effects mentioned above).

What this study strongly suggests is that placebo effects, however, are not real physiological effects worthy of pursuit. They are largely, if not entirely, non-specific therapeutic effect and statistical illusions.

Conclusion

CAM modalities are largely treatments looking for an indication with claims looking for a justification, and now negative research results looking for a rationalization.

The next rhetorical battleground seems to be placebo medicine. Once again CAM-friendly researchers are trying to bolster their position with research, and once again to the extent that technically good research is being done, the results are not supporting their position. And so the spin and marketing begins.

In the end, placebo effects do not appear to be a sufficient justification for any particular treatment ritual. The other conclusion we can draw from the data in this study is that the magnitude of placebo effects for objective outcomes was no greater with a ritual of treatment than with no treatment at all. Further, the magnitude of placebo effects for subjective outcomes was no greater for the elaborate ritual of acupuncture than it was for a simple placebo inhaler.

These results puncture the claim that CAM modalities give a better placebo effect that real medicine.

In other words – any component of the placebo effect worth having you can get from science-based medicine. Pseudoscientific rituals are not necessary – and they come with added risk of promoting pseudoscientific beliefs in health care. As James Randi, who founded TAM, famously said – “It is a very dangerous thing to believe in nonsense.” This is perhaps most true in the field of medicine.

 

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64 responses so far

64 Responses to “The Rise and Fall of Placebo Medicine”

  1. Enzoon 19 Jul 2011 at 11:39 am

    Great write up! Dr. Gorski’s was amazing as well. I love the graphs. I am definitely going to download them to my phone to have on hand when I get into arguments about this stuff.

    You have to tip your hat to CAM proponents, though. Somehow big pharma questionable marketing equals scandal. CAM questionable marketing somehow becomes fighting the evil suppression of science.

    I’m at a loss in understanding this “use it as placebo” approach, though. I’m even more surprised that a lot of people think it’s reasonable. I almost think we should start replacing the use of the word placebo with “fake” or “sham” to stress the true nature.

  2. TimonTon 19 Jul 2011 at 12:26 pm

    Thanks for the helpful analysis. The study certainly adds useful information to our understanding of the so-called “placebo effect”.

    My concern is that the NEJM editors and reviewers let the study authors get away with apparently completely unwarranted conclusions and, even worse, included a questionable editorial by a “medical anthropologist” (see Dr. Gorsky’s discussion for details).

    Do you or Dr. Gorsky ever consider writing your analyses in suitable form for submission as a letter to (in this case) NEJM? If not, why not?

    Thanks.

  3. PiperTimon 19 Jul 2011 at 1:44 pm

    “I would argue that we already have a pretty good idea of how effective placebo medicine is. That’s what we had in the pre-scientific medicine era, when the average life expectancy was around 40.”

    Excellent point. And great panel at TAM, by the way. It was one of my favorites.

  4. Karl Withakayon 19 Jul 2011 at 5:20 pm

    Although they attempt to cloak their ideas in other sciency sounding terminology, it seems clear that some advocates of placebo treatment are essentially invoking mind body vitalism for placebos in that they seem to believe a placebo evokes the power of “mind over matter” to harness the mind’s supposed ability to heal the body through willpower and positive thinking, The Secret, or whatever.

    To claim that the supposed mind over matter effect of self healing produces objective changes in health outcomes ignores the research, prior plausibility, and reality.

    Integrating practices with different and lower standards of effectiveness lessens medicine as a whole instead of improving, complementing, or augmenting it. Integrating unscientific and prescientific understandings of those practices drags all medicine down the the level of witchcraft and voodoo.

    It’s clear that there are numerous conditions for which subjective measures should not be the primary means of assessing effectiveness of treatment/management. Asthma, high blood pressure, diabetes, various forms of cancer, etc are all diseases for which you don’t want to rely on a subjective assessment of how well the patient feels.

  5. Karl Withakayon 19 Jul 2011 at 5:23 pm

    I’m curious, has anyone ever done a longer term study of placebo for subjective improvement of something like chronic pain? There’s at least two things I’m curious about.

    The first is whether the subjective effectiveness tapers off over the long term of receiving inert treatment.

    The other question is whether it is possible to do a more objective analysis (or find additional subjective measures) of effectiveness via, say, secondary symptoms.

    For instance, there are times where I am short tempered, cranky, or impatient because I do not realize I have a headache or am not feeling well, a person who thinks their leg pain is improved may still unconsciously favor the other leg due to continued pain, or someone may report lessened nausea, but may vomit just as often, etc.

  6. Karl Withakayon 19 Jul 2011 at 5:36 pm

    “The other question is whether it is possible to do a more objective analysis (or find additional subjective measures) of effectiveness via, say, secondary symptoms. ”

    Just to be clear, I am speaking in regards to conditions that are mostly/highly subjective in nature, like chronic pain.

    Frankly I’m not even sure why someone would test placebos for things like asthma unless they’re testing mind over matter. “Well, he died, but he didn’t seem to mind that much, let’s use acupuncture for asthma from now on.”

  7. Karl Withakayon 19 Jul 2011 at 5:39 pm

    One last self-pedantic correction,

    “Asthma, high blood pressure, diabetes, various forms of cancer, etc are all diseases for which you don’t want to rely on a subjective assessment of how well the patient feels”

    That should be how well that patient IS.

  8. fencer_guyon 19 Jul 2011 at 7:48 pm

    Something I was wondering about concerning Placebo, since there does seem to be some sort of effect does this work with medical problem with real physical systems. Like can you make an impact on cancer with a placebo? How would a placebo work with something like a broken arm or having a heart attack?

    Though I do wonder if you gave someone a Placebo and called it a smart drug would they do better on a smart type test.

    K

  9. Rikki-Tikki-Tavion 19 Jul 2011 at 8:21 pm

    I feel this will be a much tougher battleground than the “Homeopathy works because we say so”-one we had before.

    First of all, it’s tough to define an “objective effect”. I, for one, have a slight essential tremor. I’m quite sure if someone pitched me a placebo treatment the right way, it would measurably help my tremor temporarily.

    Second of all, we can only show that it doesn’t work for all ills, which is kind of a straw man. As in the previous debate, we can’t prove that it works for no indication whatsoever (as this is not a falsifiable claim). The problem now is, that, as mentioned above, placebo works for a lot of indications, not all of which can be easily thrown out as subjective. It will be even harder for Joe Average to see the point we are trying to make.

  10. SARAon 19 Jul 2011 at 8:37 pm

    I wish someone would do that study with anti-depressants. Its my suspicion that you will find that there is little or no effectiveness for all of them. That all reported improvement is placebo.
    I don’t suppose there is a way for anyone to do it, since I’m unaware of an objective criteria for the test.

  11. nybgruson 19 Jul 2011 at 9:52 pm

    @SARA:

    Funny you should mention that. The exact topic was broached over at SBM by Harriet Hall.

  12. Marshallon 19 Jul 2011 at 11:56 pm

    Hi Steve–great writeup as always. I often here proponents of CAM call to attention instances in which the placebo effect has, for example, apparently caused cancer remission. Are these myths? I assume they are. Spontaneous remission occurs, and it stands that sometimes, due to chance, a case of spontaneous remission will be accompanied by some form of CAM. But statistics should detect that.

  13. Marshallon 19 Jul 2011 at 11:56 pm

    I wish I could edit my posts–I obviously meant “hear” and not “here”…what a miserable mistake.

  14. SARAon 20 Jul 2011 at 1:15 am

    # nybgrus Unless I read it incorrectly, no one has done an objective, (non-self reported) study.
    And I think its because there are no objective and consistent physiological criteria to compare?

  15. nybgruson 20 Jul 2011 at 1:44 am

    @SARA:

    I would say that is correct, since depression is a subjective symptom. There is criteria for defining it, but each aspect of it is subjective reporting of specific symptoms. There is some rigor to it, since we find correlations between those subjective reports and outcomes, and we have some physiological data to demonstrate a strong link between neurotransmitters and depression (further reinforced by the fact that drugs working on said NTs are found to alleviate symptoms of depression compared to controls). However, we do not have a way of directly measuring some sort of objective physiological parameter to determine if your depression is worsening or getting better. Indeed, even measuring NT levels at synapses would be ineffective (if we could do that) since the drugs act very quickly (on the order of a day or two) but clinical relief takes weeks. Thus, it is not a direct effect of simply increasing NT levels that is in effect.

    To me, this means that there is some sort of re-modeling of neural pathways that is involved in the pathogenesis of depression. This would explain the familial inheritance patterns, the concordance between twins, as well as the time delay for pharmacotherapy to work. It would also explain why psycotherapy can also elicit similar responses and why combined pharma therapy + psychotherapy do better on the whole. The NT disbalance reinforces the negatively skewed neural restructuring and the drugs help alleviate that and allow for beneficial remodeling. Until we can measure, identify, and quantify this neural remodeling I don’t think we can have objective measure of depressive states (and other such subjective diseases/disorders).

    That’s just my opinion though in synthesizing my knowledge and experience. It could easily be a “just so” story, so take it with a grain of salt, but it seems reasonable to me.

  16. Mlemaon 20 Jul 2011 at 2:05 am

    Why would it be important to have an objective measure of depression for the individual who says he’s not feeling as depressed?

  17. Mlemaon 20 Jul 2011 at 2:09 am

    What would interest me is how things might go in the case of someone who’s obviously suffering from depression but is not cognizant of that (doesn’t recognize it). But how would you ethically test in that situation? Can’t think of a reasonable way to do that. I guess any ethical practitioner would mostly just want to work with the person to help them see they could be happier and get more out of life. That is, recognize their depression. Then treatment might be pursued.

  18. nybgruson 20 Jul 2011 at 3:04 am

    @Mlema:

    That actually happens a lot right now. People can be depressed and not recognize it, deny it, or not want to treat it. We can’t do anything about it unless we can establish that they are incompetent and/or a danger to self or others in which case a medical hold can be placed and treatment against will ensue. Of course, that is a last resort, and doesn’t help anyone but the most extreme cases. But that wouldn’t change whether we had an objective assessment or not.

  19. wjlroeon 20 Jul 2011 at 4:53 am

    Correction (paragraph 2) should read: “Over the last two decades the public and the scientific community have been told by CAM”… (rather than ‘have be told’)

  20. davidsmithon 20 Jul 2011 at 8:20 am

    Steven said,

    For objective physiological outcomes, there is no significant placebo effect. Placebos are no better than no treatment at all.

    This further means that there is no expectation effect or mind-over-matter effect that has a measuring objective physiological effect.

    Have there been any other studies of this kind involving a comparison between placebo and non-intervention groups with an objective physiological measure other than FEV?

    If something like a “mind over matter” expectation effect is possible, perhaps it works better in certain healing situations than others?

    I’m reminded of the situation of limb regeneration in developmental biology. We know that certain chemicals involved in biological regeneration are more effective on certain tissues and at certain stages of developement. A baby might have a chance at growing back the tip of a finger, but an adult would have no chance at growing back an arm.

    So, I’m wondering if the authors chose the right kind of system to study?

  21. Laurataron 20 Jul 2011 at 9:47 am

    ok…

    it seems we’ve established

    1) placebos can promote measurable and often clinically significant improvements in self-reported subjective outcomes in a variety of diseases and syndromes…..

    2) the effects on placebos on objectively measured outcomes appear to be marginal at best (and likely non-existent for parameters which are not manipulable by the subjects or investigators)

    3) the use of placebos as primary therapy for any disease associated with significant increased morbidity and mortality can not be ethically justified….

    so….this still leaves numerous clinical scenarios in which a placebo effect may be of benefit, and where there may be value is having the ability to harness the placebo effect….these conditions can be typified as

    1) having no direct effect on mortality and physical morbidity
    2) having a lack of abnormal findings that are either demonstrable on physical examination or by detectable through clinical investigations
    3) leading to a decrease in health related quality of life and/or consumption of health care resources

    specifically, I referring to diseases and syndromes like irritable bowel syndrome, fibromyalgia, chronic fatigue syndrome, migraines, major depression…this list is not exhaustive, though these are probably the most common conditions which fit this criterion (and as a slight modifier, I know depression can lead to an increased mortality through suicide, but this mortality is not related to the direct physiologic effects of the disease process….)

    perhaps not totally coincidentally, there are few effective proven medical therapies for many of these conditions….even when some medical therapies are available, the response rates over placebo are fairly marginal…therefore, many patients with these conditions have used all available proven therapies, and still are left with a significant burden of symptoms…

    these are the patients in whom the placebo effect may be potentially useful….and in my practice, i think it is reasonable to looks for ways of allowing my patients to benefit from this placebo effect…..which is why I often find myself in the position of not advocating against (though not quite vigorously endorsing) the use of CAM…..

    As a gastroenterologist at a tertiary care centre, roughly 75% of my referrals are for function bowel diseases like irritable bowel syndrome, and roughly one-quarter to half of these patients have exhausted medical options and are still symptomatic…..when a patient in this situation asks about probiotics, or acupuncture, or similar….my line is that although I cannot explain why this would or should work, some patients have used them and felt better, and who am I to argue with how a persons says they feel…..

    So, I’m curious as to what the collected wisdom of the commentariat believes about the use of placebos (or placebo-like interventions) in these clinical settings……

    Laura

    specifically, I’m referring to diseases like fibromyalgia

  22. ccbowerson 20 Jul 2011 at 10:16 am

    “What would interest me is how things might go in the case of someone who’s obviously suffering from depression but is not cognizant of that (doesn’t recognize it). But how would you ethically test in that situation?”

    Thats where family and friends are important. These are difficult situations, but often the person really knows that something is wrong, but they are in denial or attribute their symptoms to other conditions. Sometimes depression is a reasonable response to difficult circumstances, and addressing those circumstances should be a major focus. Also there is nothing wrong with a clinician bringing up the subject and gauging a person’s response to the question.

    There still is an issue of stigma when evaluating treatment options, since the perception of taking medications such as SSRIs or NSRIs versus talk therapy such as CBT. This leads to the underuse of CBT, which in my opionion should be used as least as often as medication in an ideal world

  23. mufion 20 Jul 2011 at 10:46 am

    Mlema said: What would interest me is how things might go in the case of someone who’s obviously suffering from depression but is not cognizant of that (doesn’t recognize it).

    There’s a word for that – anosognosia – and it can really complicate treatment and recovery.

    I say that, not as a medical professional, but as a parent of a child (my first daughter) with anorexia nervosa, of which anosognosia is a common symptom (along with egosyntonic and denial).

    We’re at a point now where she has long since been re-fed (with no relapse, as of yet), such that our pediatrician sees no “objective” signs of starvation. But her thoughts (when expressed verbally) and behaviors (e.g. around meals) are still very much influenced by the disorder, as is clear to the rest of her treatment “team” (namely, her family, psychotherapist, and nutritionist).

    I’ve read that anosognosia may characterize schizophrenic and bipolar disorder cases, as well, and I imagine that the diagnostic criteria overlap in the general sense that nybgrus described (“they are incompetent and/or a danger to self or others”).

  24. Steven Novellaon 20 Jul 2011 at 10:51 am

    Imagine if there was no objective physiological measure with asthma, and we only had subjective symptoms to go by. Albuterol did only slightly better than placebo for subjective symptoms.

    But – we know it works as it has a significant improvement in lung function.

    So, for treatments that only involve subjective symptoms, we have a hard time demonstrating improvement over placebo because much of the response is obscured by the strong placebo response. This is probably the case with depression.

    If anything, the small improvement over placebo may be more significant than it may appear.

    That is why a physiological measure of depression would be so helpful.

  25. Steven Novellaon 20 Jul 2011 at 10:56 am

    Even for subjective symptoms – placebo effect may be mostly statistical effects and reporting bias – not a real (if subjective) improvement in symptoms.

    Those studies that have tried to separate out the various placebo effects indicate that a real subjective improvement is a small component of the placebo effect and is generally short-lived.

    In any case – whatever component of the placebo effect for subjective symptoms is useful can be gotten with science-based treatments. You don’t need to lie to patients or pretend magic is real.

  26. ccbowerson 20 Jul 2011 at 11:34 am

    “That is why a physiological measure of depression would be so helpful.”

    I’m not sure what you mean here since depression is by definition a subjective experience. Any physiological measure would have to be correlated with some measurement of depression, and this physiological measure would then be a surrogate marker for the condition of depression. Such a marker would have utility, but I’m not sure that measuring efficacy of an intervention is the best use of such a marker (but perhaps would be a screening tool?). We are still primarily interested in specific patients actually feeling better and their lives improving.

  27. Steven Novellaon 20 Jul 2011 at 11:42 am

    I agree – but we want patients to actually feel better, not just report that they feel better. And we want them to do better long term, not just give the illusion of doing better because of short term effects or regression to the mean. And we don’t want to waste time with therapies that are adding nothing to the non-specific effects of the therapeutic ritual (especially if they represent a waste of time and resources or convey risks or side effects).

    And – by knowing what actually works that helps our knowledge of depression which will help design the next generation of treatments.

    If we can develop a reliable marker of depression (say with fMRI or EEG) – a marker that also correlates with successful treatments, this will help us put the messy information we get from clinical trials into perspective and better judge when we have a truly effective treatment vs a placebo illusion.

  28. Laurataron 20 Jul 2011 at 12:23 pm

    “Even for subjective symptoms – placebo effect may be mostly statistical effects and reporting bias – not a real (if subjective) improvement in symptoms.”

    It may be….but it may also be inducing changes in perception that allow people to feel better (even without alteration of the underlying pathophysiology)

    “Those studies that have tried to separate out the various placebo effects indicate that a real subjective improvement is a small component of the placebo effect and is generally short-lived.”

    I agree…..placebo effects tend not to be enduring, but perhaps even a short-term perceived benefit may be preferable to none at all, and there may be a small number of people, who for a variety of reasons, may perceive a more sustained improvement….whether this represents self-delusion, a failure of long-term memory, or real changes in perception, who knows…and keep in mind, I’, talking about using these placebos only situations where there are no proven science-based therapies, or where these therpies have been exhausted

    “In any case – whatever component of the placebo effect for subjective symptoms is useful can be gotten with science-based treatments. You don’t need to lie to patients or pretend magic is real….”

    it’s not a matter of lying to patients, but working with their psychology to maximize the chances of improvement (and lower consumption of health care resources, and improved functionality….

    .i agree that in an RCT, when both active medication and the placebo have an equivalent response rate of let’s say 40%, that the “benefit” seen with the active drug is really a placebo effect……but if I am given the choice of prescribing a medication (which by the time it gets to Phase III testing, has been demonstrated to have some physiologic effect in most cases, and thus potential side effects and adverse effects), and letting people prick themselves with needles (physiologically useless, but minimal side effects, I’m more inclined to let them needle themselves……

    I am very much less supportive of sending agreeing with CAM when that CAM may have adverse physiologic effects (chelation, naturopathy as examples…..)

  29. ccbowerson 20 Jul 2011 at 1:35 pm

    “If we can develop a reliable marker of depression (say with fMRI or EEG) – a marker that also correlates with successful treatments, this will help us put the messy information we get from clinical trials into perspective and better judge when we have a truly effective treatment vs a placebo illusion.”

    I see. I was thinking about it in a clinical sense for specific patients, and you were largely describing it as a tool to evaluation treatments in a trial. I can see that if the marker was sensitive and specific enough this could be very helpful. Perhaps one day such a marker will be possible, but it seems pretty far off.

  30. nybgruson 20 Jul 2011 at 5:50 pm

    I agree…..placebo effects tend not to be enduring, but perhaps even a short-term perceived benefit may be preferable to none at all, and there may be a small number of people, who for a variety of reasons, may perceive a more sustained improvement….whether this represents self-delusion, a failure of long-term memory, or real changes in perception, who knows…and keep in mind, I’, talking about using these placebos only situations where there are no proven science-based therapies, or where these therpies have been exhausted

    Let me preface by saying this is not an attack, just my opinion and I am open to critique.

    To me, that sounds like passing the buck. When I read this I read:

    “Well, I am out of things to help this patient. Maybe I can tacitly encourage [insert CAM mumbo jumbo] or find some other way to induce a placebo response. Even if it is short lived and not real, the patient will feel and think I am actually doing something, saving me face in having to tell him/her I am out of options. And I can justify this by rationalizing that just maybe this one patient may be in that small subset where the placebo effect will be more pronounced and lead to something better.”

    I can appreciate how the desire to help the patient at all costs comes into play. I am still only in medical school but I do have clinical experience under my belt and know why I got into this. But, IMO, it is always unethical to give a placebo as treatment. If you honestly don’t know the effects are pure placebo (say, for example, if anti-depressives turned out to be pure placebo) then I can understand reaching for it. But when it is demonstrated to be so, as in acupuncture, or you have very good reason to assume it is so, like homeopathy (and thus need no RCTs), then I feel an ethical obligation to tell the patient so. Offer to continue working on symptoms as best you can, research the hell out of it, use your knowledge to come up with some ideas, reach out to colleagues, whatever. Yeah, it takes more work – but that is the best patient care and most ethical thing to do. Offering, especially knowingly, some kind of placebo treatment (whether through tacit endorsement or explicit recommendation) is just passing the buck so you can convince the patient you did something and save yourself some time, effort, and face.

    I would also have to respectfully disagree with the statement:

    and as a slight modifier, I know depression can lead to an increased mortality through suicide, but this mortality is not related to the direct physiologic effects of the disease process….

    My understanding of the pathophys and pathogenesis of depression is that it is an actual remodeling of neural pathways either triggered by, in response to, or reinforced by decreased serotonin and/or noradrenalin levels (not in all cases, but in many). Thus, since suicidality is a concsious decision it would be influenced strongly by such remodeling, and a person who would not have committed suicide prior to the onset of their depression would do so now (as evidence by the studies demonstrated a significant decrease in suicide rates when depression is treated via anti-depressants and/or CBT). Thus, I would say that the mortality of depression is a direct extension and result of the disease physiology itself.

  31. Mlemaon 20 Jul 2011 at 7:49 pm

    Sometimes i think I don’t express myself very well. I was questioning the purpose of looking for objective improvement in symptoms of depression when a patient says “I feel better”. Do you want the improved status to be put in doubt?
    But there are symptoms of depression that others can see. It may still be a subjective observation, but it’s not the patient’s own, so wouldn’t be influenced by placebo (unless the observer participated in the administration somehow, and reported that they saw improvement because they felt like they should) But one problem with depression is that the sufferer often doesn’t realize they are feeling bad compared to “normal”. Perhaps they’ve been depressed since youth. It’s not until they’re treated that they realize they were, indeed, depressed. Would a person like this benefit from placebo? We couldn’t really find out without first ensuring that they were aware they were being treated for depression. It would be unethical to perform any intervention on someone without their understanding – even if you’re just giving them a sugar pill. As it would be in any such situation. So you can’t really test placebo in someone who doesn’t even know what you’re treating them for. So, although it would be interesting to know if a placebo would help someone who, regardless of whether they knew they were receiving a placebo or not, didn’t even know why they were being given anything, since they don’t realize they’re depressed. As others have said, it’s more common that a person does know something’s wrong, so the situation would be unusual, I think. I was just conjecturing on the impossibility of testing a placebo for a condition that the patient was unaware of. We know placebo has an affect for people who believe that it’s going to help with some particular thing. Perhaps the question isn’t entertained by researchers because they already know that if you give someone a placebo for no apparent purpose (the patient doesn’t think there’s anything wrong) then there’s no reason it should do anything at all, since it’s physiologically inert.
    So, only my first question is really not a pointless one. And that is:
    Why would it be important to have an objective measure of depression for the individual who says he’s not feeling as depressed?
    And I guess the answer is: if the person is a danger to themselves or others. And of course, in that case, you wouldn’t want to fool around with a placebo anyway. You’d want something that the doctor believed in too.
    Also, to the health practitioners here: I’m glad you do broach the subject with patients you suspect are depressed. It’s a bad one.

  32. Mlemaon 20 Jul 2011 at 10:30 pm

    mufi, although our interactions here have been brief and we don’t really know each other too well, I know that you are a sincere and compassionate person. Now I know that you are courageous as well. Even though we speak anonymously here, I am loathe to share much detail about myself. When you shared the story of your daughter, I was filled with compassion for you. My heart goes out to you. I have intimate knowledge of the kind of struggles you may be going through in your family. What I want to share with you, because of the love I feel for anyone like you is: I have “studied” this sort of disease for many years (three individual cases), and have seen that family dynamics are fundamental to the situation. The relationships between parents and children, siblings, and even extended family in many cases, all play into the development and course of the disease. There is chemical imbalance. But it’s hard to know what is cause and effect here. While doing everything you can via medication and counseling for her, I highly recommend family counseling with someone very experienced in eating disorders in the context of family. The perceptions and attitudes of the child have a lot to do with the disease, and those perceptions and attitudes cannot change in isolation from the intimate environment of the family. Family counseling gives you all the chance to examine how you relate to each other. Your daughter is fortunate to have a parent who is extremely intelligent, and, as such, able to play the dual role of scientist (able to objectively help the situation) and self-evaluating parent, willing to be a part of the situation he objectively helps. I send you my best and beseech whatever powers may be to send you and your family strength and love.

  33. Laurataron 21 Jul 2011 at 12:05 am

    nybgrus….

    I think you’re mischaracterizing what I’m getting at somewhat…..my goal as a physician is to improve health, all the while minimizing the risk of harm, whether we’re talking grievous harm or nuisance side effects…..many (although not all) placebo therapies have the ability to provide subjective, though limited benefit at minimal levels of harm. Using unproven pharmacologically active therapies may not necessarily be any better than placebo, and may potentially cause harm…

    now remember, I’m not talking about cancer, cardiovascular disease, hypertension, diabetes, etc….I’m talking about purely functional syndromes…..

    So let me lead you back to my example or irritable bowel syndrome, or IBS….this is a condition where people report any of a number of gastrointestinal complaints (abdominal pain, bloating, alteration in bowel frequency and/or consistency), for which no organic cause can be found.

    First, IBS does not lead to increased mortality, it does not induce other organic disease (i.e, it does not turn into inflammatory bowel disease like colitis, it does not increase the risk of cancer).

    Second, there are no definitive diagnostic tests; a diagnosis is based on the presence of consistent symptoms and the absence of demonstrable organic disease, and its stability over time.

    Lastly, there is no permanent cure, few pharmacologic therapies have been approved for its treatment, and those which have been approved have only limited incremental efficacy over placebo in RCTs, and many have side effects which limit their overall effectiveness in practice. It is also worth mentioning that two IBS medications, alosetron and tegaserod, have been pulled off the market or subject to restriction because of the rare, but serious adverse effect of ischemic colitis. There are other oharmacologic therapies which have been advocated for IBS (tricyclic antidepressants, neuroleptics, promotility agents), for which there is either no RCT level evidence, or RCTs have been performed that showed no significant incremental benefit, but where proposed mechanisms of drug action could support their use….

    So lets bring the patient back in the room……she’s been suffering with symptoms of IBS for years….and you’re a top-notch physician, you’re knowledgeable, you stay up-to-date with the medical literature, and you’re aware which therapies are supported by the science, and which are not…..

    She’s tried all the “proven” pharmacologic options, and may have had some improvement, but still has a high symptom burden, and maybe you’ve even tried all the not-totally proven therapies, which either haven’t worked, or have been limited by side effects…..so now what do you do?

    There are many instances in clinical medicine where effective options are few, and even when they are not few, they are definitily finite….there will always be the patients in whom you reach the figurative end of the road…and while I am hopeful that further research will eventually provide new insights which will lead to better therapies, this does little to help the person in front of you in the exam room…..

    It is in these situations where I 1) acknowledge the limitations of conventional medicine, 2) elaborate that I cannot think of a scientific reason why alternative therapies work, 3) acknowledge that many people still report subjective improvement with these therapies, 4) caution against CAM modalities that may be harmful (ingestion of mystery herbs, radical dietary alterations chelation), and 5) respect a patient’s decision to seek out these therapies, given that you have run out of therapeutic options.

    I’m sorry if this comes across to you as “passing the buck”, but this is the reality of clinical medicine…..I was much more strident earlier in my career, but experience and clinical reality has softened my stance somewhat…..perhaps if you’re looking for an interesting clinical rotation as part of your medical education, feel free to spend some time in my clinic, and gain some perspective, and if I’m fortunate, maybe teach me a thing or two…..

  34. nybgruson 21 Jul 2011 at 3:56 am

    lauratar:

    Thank you for taking my comments as they were intended and offering such a thoughtful reply. I fully realize that I have barely begun my career in medicine and (as Harriet Hall has pointed out) there are many times a nuanced approach must be taken in an exam room. I’m sure my stance will change, adjust, and vary slightly from patient to patient and time to time. Such is the nature of our profession. I also tend to think of my current stance not as stridency, but as idealism and youthful zeal – shooting for the stars and knowing I will fall short, but hopefully still land on the moon.

    I also recognize that there is a distinct difference between a professional stance on CAM and how you actually deal with a patient in front of you suffering.

    I think your example of IBS is a very valid one, but that such situations are indeed rare (i.e. a condition with no mortality associated with it, no reliable objective test for it, and such limited science based treatments available). The problem I have, is that once you have admonished your patient that you can’t imagine how (or at least or uncertain how and dubious of) CAM treatments would work, and warned them against modalities with distinctly possible serious adverse effects, what are you left with? Homeopathy is about the only one I can think of.

    I can understand the need to bend the rules sometimes. For example, after a couple of years working in the ER I became comfortable being able to “read” patients. I would frequently get the college kid, who’d often just had some beers and smoked a joint, come in with a minor fracture or something of that ilk. I’d splint him/her up and give them discharge instruction, which included a script for vicodin. I mention how you shouldn’t mix it with alcohol and see the look in his/her eyes. So I break the rules and tell them it is OK to mix in a beer – it won’t kill them. I explain it will give them a high and add to the effects of the drug and I explain that it really isn’t very healthy and I wouldn’t recommend doing it. But, I say, if you are going to do it anyways, know that one beer with one or two pills won’t kill you, but if you have more than that it could really mess you up. In other words, I told them the truth, knowing that most likely they would do it anyways, and without knowing the limits were more likely to hurt themselves.

    I just have some trouble finding a way to do the same thing with CAM. In the above example I was proactive in educating a patient that I had good reason to suspect would likely do something harmful to themselves anyways in a way to try and minimize that harm. For CAM, I feel that me making the suggestion to use CAM could not be ethically justified. But what if the patient asked me specifically? I suppose I would give them some sort of similar spiel about it, tempering my words carefully and being clear on what I understood about the relevant science and then simply respect their autonomy and ask that they keep me in the loop so I can be better able to manage their health.

    However, on a professional levels, with colleagues, and publicly I think a firm (even strident) stance is necessary. The issue, I think, is not so much that the IBS patient who is well informed but out of options tries acupuncture or homeopathy – they are a minority and will likely not continue wasting money on it if they don’t feel improvement. It is for the mass of people that buy into the false dichotomy of CAM vs Western Medicine, that have the wool pulled over their eyes by the sCAMsters, in other words the ones who use CAM instead of proven modalities when life and limb are at stake. If, as a profession, we are anything but staunch in that stance, then CAM finds a foothold – we’ve seen that aplenty. And of course, the professional stance starts with the individual professional. That is why I make it a point to write on the internet about this, discuss it with my classmates, and challenge my professors on the topic. And I think that is what the point of this blog and SBM (among many others) is – to raise that professional awareness while offering a science based bastion of information for the average healthcare consumer who is, quite reasonably, not savvy to this sort of thing. Because when UCSF and the Mayo Clinic start touting CAM (which they have) what else is the average Joe supposed to believe? That, IMO, is our professional failing of letting these sCAMsters “integrate” into medical curriculum and care.

  35. surfiemicon 21 Jul 2011 at 5:03 am

    Hmm, interesting blog and interesting comments. Just to establish something straight up, I am not pro CAM and i’m not Pro medicine – I’m pro well being and preventative medicine (an exercise scientist and motor behaviour researcher), something both sides of this story fail at addressing.

    Medicine is also pseudoscience at best, just more efficient than any alternatives. Now this idea of placebo medicine being purported IS insidious, I whole-heartedly agree. But slightly hard to take change of tack needs to be pointed out – the whole idea of “science based medicine”. With this re branding of “evidence based medicine”, it appears that establishment just had to add this to make themselves even less able to be attacked, hiding behind the truth seeking edifice of science. Science is at best flawed and medicine is at a whole other level of muddiness. In all skeptic blogs I have come across, it is very difficult to put a critique in, without being accused of being a CAM proponent or sympathizer. If medicine wants to borrow the science tag, then this debate should be more encouraged.

    This whole “us vs them” dualism is just so outdated; my question is, why cant there be a non reductionistic medicine? Science is actually streams ahead here (than medicine), although regrettably this is the sort of stuff CAM people like to take and run with (and completely misunderstand). As long as medicine continues to run with the “broken machines which need fixing” mentality and ignoring the fact we are human beings, of course people will look to alternatives – it is sad to see that people must waste so much time and effort to find this recognition. Science recognizes the many dimensions of health i.e. any body who seriously thinks that emotions don’t have any influence here is clearly crazy. “Mind over matter”, impacting on objective measures, is not an uncommon finding in scientific literature.

    A couple of what I see to be flaws in the logic of this blog article are as follows… Now in said example of asthma drug, improving function as well as subjective measures – this is fine; give me the drug any day. But this is a very simplified case. As many comments have pointed out, there is often a dissociation between objective function measures, and subjective ratings. To discredit subjective feelings in the hunt for the all elusive objective-measure-of-everything, we ignore the very thing to be human is – a subjective experience. Why should we not look for things to make us feel better, while we get better? Medicine can fix, but its attitude means that it cant heal, it can’t bring us back into health in all cases.

    Also the whole life expectancy statistic provides another example of the blind desire for objective measures and the problems therein. Medicine claims the improvement in life expectancy – in fact this is not true; mostly due to improved hygiene and reduced infant mortality (yes medicine comes in there, but the whole idea of prolonging life is misleading if you understand how the statistic is calculated). So we may be living longer yes, and medicine has something to do with that… But have you visited an aged care facility recently? We are staying alive longer yes, but are we living better? no. Quality of life measures tell another story. If we cant work out the true cause of our illnesses, and we cant look forward to a better quality of living, where is the worth in that?

    All, even hardcore neurocentric medicine skeptics need to continually question assumptions, rather than just oh so proudly demolishing other forms of pseudoscience. To not so is dangerous for all our well being. A critical mind is required, however it is critical that it is open also…

  36. nybgruson 21 Jul 2011 at 9:12 am

    oh dear

  37. PhysiPhileon 21 Jul 2011 at 9:32 am

    @surfiemic

    “But slightly hard to take change of tack needs to be pointed out – the whole idea of “science based medicine”. With this re branding of “evidence based medicine”, it appears that establishment just had to add this to make themselves even less able to be attacked, hiding behind the truth seeking edifice of science.”

    I believe the term science-based medicine was coined my Dr. Novella in order to prevent superfluous spending on highly implausible and exhaustively studied medical practices like homeopathy.

  38. ccbowerson 21 Jul 2011 at 9:42 am

    “Just to establish something straight up, I am not pro CAM and i’m not Pro medicine”

    A preface before the crazy starts. Actually the post was slightly less crazy than I expected, but still misguided.

    “Medicine is also pseudoscience at best”

    Umm no. A pseudoscience is a practice that claims to be a science but uses unscientific, untestable, and implausible methods (this is not intended to be an all encompassing definition). Medicine is a practice that uses science whenever possible for the treatment and prevention of disease or illness. The individual interventions are testable, and utilize science to guide the practice. The fact that the process is not perfect is not evidence for your absurd pseudoscientific claim.

    “Medicine can fix, but its attitude means that it cant heal, it can’t bring us back into health in all cases.”

    I’m not sure what you are talking about here, the middle of this sentence is pure nonsense and the latter part is a non sequitur.

  39. 2_wordson 21 Jul 2011 at 10:15 am

    @surfiemic

    I didn’t know that there was anyone out there that was anti-preventive medicine and anti-well-being.

    It is interesting how one can be “not Pro medicine” but still be “pro preventative medicine. “

  40. mufion 21 Jul 2011 at 10:52 am

    Mlema: Thank you for your kind words. I really do appreciate them.

    We were lucky in at least two ways: we caught her anorexia early on (when she was 13); and we quickly discovered the Maudsley method of family-based therapy (FBT) as the most evidence-based option to date.

    Unfortunately, we live in a region where therapists with Maudsley training & experience are locally unavailable. (Harriet Brown described a similar situation to ours in her recent autobiography, Brave Girl Eating.) However, our therapist was already doing another type of FBT (albeit, with a focus on addictions, rather than eating disorders), so integrating Maudsley principles into her practice was not a huge stretch for her, and she’s been very receptive to it so far.

    Thanks, again.

  41. icewingson 21 Jul 2011 at 1:00 pm

    @SARA –
    Why would you assume that anti-depressants would show little or no objective effect than placebo? What are you basing this on?

    It seems to me that if the subjective responses generally indicate improvement, and objective responses have not yet been measured due to lack of an appropriate technology to do so, then the logical assumption would be to assume anti-depressants are more effective than placebo in general, although perhaps not quite as effective as subjective measures would indicate.

  42. Mlemaon 21 Jul 2011 at 2:28 pm

    mufi, I’m so happy to hear that. I should have known you would find the very best way to help her. But for myself I had to say what I was thinking. There is so much emotional suffering for the victim of anorexia, and I am glad to know a young woman who’s affected has a strong parent to help her. Thanks for replying.

  43. Laurataron 21 Jul 2011 at 3:27 pm

    @nygbrus

    Unfortunately, diseases like IBS are quite prevalent…..If you have a general clinic, you will likely see a difficult to treat patient with IBS, fibromyalgia, chronic fatigue syndrome….and this does not even count the diseases for which there are numerous effective therapies, but where patients are still left with frequent debilitating symptoms despite optimal medical management (migraines, rheumatoid arthritis, inflammatory bowel disease, the list goes on and on)…..never mind if you’re a specialist, where much of your practice may be comprised on these patients

    many studies have shown a high prevalence of CAM use among persons with all sorts of treatable diseases, and most are using as a complement (as opposed to an alternative) to conventional medicine……I don’t take this as evidence of effectiveness for CAM, but a function of our limitations as physicians to alleviate all symptoms (despite best efforts)

    And I agree, it is possible that my lack of a overwheming endorsement may decrease the potency of any placebo benefit, but i have to draw the line somewhere….and as for side-effect free CAM, in addition to homeopathy, I would add in healing touch (Reiki), low-impact chiropractic, massage, acupuncture, and don’t forget prayer……once again, I don’t think any of these work (aside from massage and low-intensity chiro for mechanical lower back pain, and even there, the data is weak), but the negative effects (outside of financial) are minimal…..

    laura

  44. mufion 21 Jul 2011 at 4:26 pm

    Laura, thanks for sharing. You raise some valid points.

    But I will say this: As a consumer on a low budget, I take quite seriously the cumulative negative financial effects of purchasing medically harmless, but otherwise unhelpful, treatments. (For example, if I spent the way my CAM-enthusiast friends do, I would surely be bankrupt by now.)

    Also, long-term, I worry about a “gateway” relationship between the ‘C’ and ‘A’ in “CAM” – say, if a patient falsely attributes a positive outcome to an inert treatment in a complementary scenario and then next time decides to skip the “Western/allopathic” treatment altogether and go with a strictly alternative approach (possibly even in a scenario involving “cancer, cardiovascular disease, hypertension, diabetes, etc”, although I expect that most folks will try to hedge their bets under such circumstances).

    While a harshly politicized lecture would seem ill-advised, a polite, dissuasive comment by a trusted physician can potentially save someone a lot of money, if not more than that.

  45. mufion 21 Jul 2011 at 4:48 pm

    PS: While I realize that meditation and yoga are also considered by some skeptics to be “gateway drugs” to nonsense, they also seem to be more widely recognized as having medical benefits (i.e. above mere placebo effects). If I have not been deceived in this regard (I am not a medical expert, after all), then perhaps recommending these practices instead of a typically inert CAM modality (homeopathy, acupuncture, healing touch etc.) are an ideal compromise with patients who harbor CAM sympathies.

  46. nybgruson 21 Jul 2011 at 4:49 pm

    @laura:

    I can see your point about the prevalence of such chronic conditions. Honestly, I think it is just one of those things I’ll have to wait to really figure out once I get there – I’m not cold hearted to stand my ground relentlessly no matter what. Once the clinical becomes my daily life, I am sure I will have to modify my stance (to the individual patient) in some way.

    I would take issue with a bit of word choice, not so much to be pedantic, but because the sCAMsters win by word choice. “…most [patients] are using as a complement (as opposed to an alternative) to conventional medicine” – I would say that they are using as an “addition” because magic joo joo does not “compliment” actual medicine.

    You also agree that your word choice could attenuate possible placebo effect, agree that CAM should be strongly discouraged from use in cases with significant mortality and morbidity, and say you must draw a line somewhere. So with the patient who has, say, stage IV prostate cancer or pancreatic cancer – what would you advocate? Their condition is terminal, likely on the order of 6-12 months (even less perhaps). There is no science based treatment left to help them. What if one of these patients, while on palliation, decided to take up some sort of CAM treatment in addition? It likely won’t do anything either good or bad – but it will be a waste of their money. It might make them feel a bit better in the few months before they die, but their loved ones might well be out thousands of dollars they could have otherwise used. So what would you tell such a patient and how would you advise them?

    Or what about the Stage III breast cancer that was resected, the patient is undergoing proper chemo, etc and they want to add on some sort of CAM to help “make sure” it kicks the cancer? Once again, the CAM won’t really affect the course of their disease, but will affect their pocket book.

    I think I would be reasonably firm with them as well on the topic – financial waste is also a bad thing and something we should be able and willing to help prevent. In fact, by DSM criteria, excessive financial liability and spending is a diagnostic criterion for mania and (when the rest of the necessary criteria are met) reason enough to treat against their will. So if it seems reasonable that in the above cases (this is what I am thinking, so please give me your thoughts on those scenarios) to try and save your patient from literally throwing money in the fire, why is that any different for the IBS or CFS patient? I suppose the only difference is that science based medicine is doing something (palliation) so that is good enough to take the extra step and try and save your patient some money.

    But then, that goes right back to where I was in my first post – advising on CAM is “passing the buck” since the physician can’t bear to tell the patient that there really is absolutely nothing left to do. Then, when one’s back is against the wall, it becomes OK to advise a patient to spend their money on magic joo joo because we have nothing (not even palliation) left to offer.

    Those are just my thoughts anyways.

    I’ll finish by saying that I agree – reiki and TT and such “energy” healings do indeed have no side effects save the lighter wallet. However, acupuncture most certainly does and I cannot see it ethical to advice on it knowing that. And the problem with chiropractic is finding one that is actually “low-impact” and won’t be going hog wild with sublaxations and adjustments. These are practical considerations in terms of advice you will give your patients. Even in the best case with properly trained acupuncturists there is still risk of infection, pneumo, etc so what if your patient finds a crappy one? Can you reasonably vet one beforehand? If you recommend a specific one that is tantamount to endorsing the practice and gets into a fuzzy area I’d rather not be in. And then your patient goes there and the enthusiastic acupuncturist tells them how amazing some TCM herbal concoction is or how great cupping is or something else. And the same for chiropractic – even if the patient goes there on your own admonishment to be very limited, the chiropractor truly believe his subluxation garbage and keeps touting it and advising the patient to do X, Y, or Z. And those are the ones that I can see directly causing harm. You think a Reiki practitioner wouldn’t perhaps advise to acupuncture or TCM or some sort of herbal BS? What about the numerous sCAMsters out there who, through either their own zealous and genuine belief or because they are truly shysters, will hear that your patient is there because you ran out of options and pounce on that? I can just hear it now, “See, conventional medicine doesn’t work. If you have a broken leg, sure. But for real health issues you should come to me and my buddies here at CAM.” And the patient gets a sympathetic earful of woo.

    I’m not saying this happens all the time, but it certainly does happen a lot. For me, the consideration of endorsing any CAM modality is just not as simple as the “we are out of SBM treatments, the patient is suffering, so I will give a reasoned, mild endorsement of some CAM that is unlikely to harm but may give placebo” – there is much more to the metric on the other side since I have seen, first hand, through my undergrad degree (I have a whole fancy schmancy degree in medical anthroplogy), and from here and SBM what can and does regularly go on over at the sCAMsters shop.

  47. nybgruson 21 Jul 2011 at 4:57 pm

    mufi:

    Thank you for inadvertently reinforcing the points I just made (we were apparently typing and thinking the same thing at the same time).

    I also agree that yoga and meditation are actually fine science based modalities, as long as you eschew the mysticism of it. I personally do yoga as part of a very intense fitness regime and often self reflect quietly (meditation, basically) to relieve stress.

    Also, I didn’t chime in earlier since I am wary of doing so on the intertubes because tone and non-verbal cues are obviously impossible to read in a comment. But I will second what mlema had the courage to say and am quite glad you are finding good ways to help your daughter and that you are all making progress. I know that sort of thing is extremely difficult and I laud you for taking the time and making the effort to do the best science and evidenced based things for her. It is not my particular field of expertise, but if you ever come across something you would like an additional eye on, I’d be happy to give my assessment of it (and obviously do the necessary background on it), for whatever that may be worth to you.

  48. mufion 21 Jul 2011 at 5:04 pm

    Thanks, nybgrus. I feel even better now about sharing. (Gotta love that placebo effect! :-) )

  49. mufion 21 Jul 2011 at 5:56 pm

    Also, nybgrus, I just read your reply to Laura and feel obliged to add:

    I stand corrected on acupuncture (i.e. “there is still risk of infection, pneumo, etc”).

    And, regarding your shared concern regarding (what I called) a gateway effect or (what you called) a “fuzzy area” (reiterated in your later caveat re: yoga: “as long as you eschew the mysticism of it”), I’ve thought a lot about this topic – partly because of my milieu (I inhabit a locality that is awash with woo), and also partly because I know that my wife and I both have hippie/anti-establishment tendencies, which CAM ideology plays into nicely.

    That said, this blog (as well as the book Trick or Treatment) has been very helpful to me in navigating these fuzzy areas, while also avoiding expensive medical scams.

    Thanks, again, for your contributions to that cause.

  50. Laurataron 21 Jul 2011 at 10:49 pm

    If I am certain about one thing when it comes to clinical practice, it is that I can’t be certain of anything…..maybe I’m helping patients feel better by leaving the CAM window open, maybe I’m not, but who knows…..though I strive to be evidence-based as much as I can in my practice, the vast majority of the decisions that one has to make in a given day of practice are generally at most partially informed by the evidence…….

    perhaps one day someone will perform a well designed trial where patients who have exhausted reasonable evidence/science based options for their specific condition will be randomized to exploring a harmless CAM option vs being told that all options are exhausted, and the prospectively followed for changes in reported satisfaction, general HRQoL and disease-specific HRQoL, and we’ll be a little closer to knowing the truth….until then, we’re dealing with best guesses…..

    i am cognizant of the potential expense of CAM as well, yet many physicians don’t think twice about prescribing medications for off-label indications where evidence is scant, of poor-quality, or non-existent…i’m quick to caution patients when it comes to CAM that if they don’t feel they’re getting their money’s worth (in terms of a sense of subjective improvement) than not to throw good money after bad…..the same as if I prescribe a proton pump inhibitor at $80/month for non-ulcer dyspepsia (ulcer pain without an actual ulcer, absolute benefit over placebo in RCTs: approx 10%) , and it’s not helping their heartburn or stomach pain, I don’t insist they keep taking it…..

    in any case, I recognize we’re of differing opinions here, and it’s not my goal to convince you or anyone by night’s end as to the absolute merits of my position……part of the benefit of being a skeptic, is that you(pl) and I are free to change our minds at any time, as the evidence and experience best dictates, and having a reasoned and reasonable discussion makes the effort all the more worthwhile……

  51. nybgruson 21 Jul 2011 at 11:20 pm

    I agree Laura, as I hope was evident by my responses. I appreciate your thoughtful and conscientiously voiced point of view. There are indeed many ways to skin a cat (as they say).

  52. Mlemaon 22 Jul 2011 at 7:11 pm

    nygbrus:
    there are many ways to cook a potato
    (nouveau saying) :-)

  53. carykohon 23 Jul 2011 at 3:55 am

    So here’s the rub with CAM, say I have patient with low back pain. That’s difficult to treat. I’ve tried conventional, and it hasn’t helped them. They ask about acupuncture. I tell them that there’s no evidence that it helps, but some patients report a subjective benefit to it. We decide that a subjective improvement is better than no improvement. Patient goes to acupuncturist. Acupuncturist does their thing, patient feels better. Acupuncturist then suggest that they can treat their asthma, or hypertension, or whatever. Is that acceptable?

    Next , I’ll say that what this study shows is that yes, placebo can give you the subjective feeling of improvement, but without the objective findings of improvement. So, in the context of this article, I prescribe a placebo to a patient, they feel better, so no longer feel they need their rescue inhaler, yet, objectively, they most certainly do need it. Is that safe? The whole thing seems outrageous to me, allowing someone to feel better without objectively changing their illness? Recipe for disaster.

  54. ccbowerson 23 Jul 2011 at 9:47 am

    “i am cognizant of the potential expense of CAM as well, yet many physicians don’t think twice about prescribing medications for off-label indications where evidence is scant, of poor-quality, or non-existent”

    I’m not sure what type of “argument” this is but it is fallacious and red herring at best. The fact that some physicians have prescribed medication with little/no evidence is not an argument for CAM as an equally bad alternative. You don’t counter one “wrong” with another… there is a third option: choose neither. They are separate “problems” that need to be addressed individually.

    The rest of your post seems to be a softened appeal to ignorance.

  55. SteveAon 23 Jul 2011 at 3:17 pm

    Lauratar: “i’m quick to caution patients when it comes to CAM that if they don’t feel they’re getting their money’s worth (in terms of a sense of subjective improvement) than not to throw good money after bad.”

    I’d suggest they throw their money at some legitimate research charity.

  56. Mlemaon 23 Jul 2011 at 5:35 pm

    carykoh
    your fears are unfounded. You’re afraid that someone receiving an acupuncture treatment (a reasonable fear would be fear of infection) would be tempted to use various CAM treatments for other more serious conditions, to the exclusion of SBM. People want SBM. They trust it. People can tell the difference between subjective relief and real treatment of a condition. All the doctor has to say is: I need you to follow up with all your regular medications even if you feel better because the real problems of your illness are not treatable with acupuncture, and the patient will do so. Perhaps you don’t realize how much stock most people put in their MD’s. Perhaps too much in my opinion, based on my own personal experiences. But that’s irrelevant. Doctors have a huge responsibility to their patients, not the least part of which is taking the time to explain everything. And, again my opinion, they need to allow for the patient’s desire to try anything they think they might want to try for relief. If the doctor can’t take the time to try to accommodate the patient’s desires by making sure they’re going about it in a safe way, then what is the doctor’s real priority? Patient’s want to feel like they can DO something, and that someone can DO something for them. i believe this is part of the placebo effect. If a doctor cannot ethically give placebo, he can make sure his patient is safe as the patient eases his own desire to DO something by searching out his own placebo. Being able to make the choice to do something which to us is simply a useless and desperate thing, may be vital for the patient’s sense of self-direction and activation of the placebo response. This places a new burden on doctors: to counsel patients who choose to pursue alternative treatment. If the patient knows the doctor thoroughly disapproves and will not support him in his search for relief, he will simply not tell the doctor what he’s doing. Doctors need to make it clear they don’t support any treatment they don’t see as offering real healing, but need to respect the patient’s beliefs instead of judging them as ignorant. I think the most ethical path is to make sure the patient is comfortable discussing everything they’re doing to treat themselves, and stress the importance of always utilizing real medical care before and ongoing with anything else they’re doing. People are going to try stuff regardless. And while it places an additional burden on MDs to “protect” their patients in this way, i don’t see how you can get around it. Except continue to try to abolish alternative treatments all together. You’ve still gotta “deal” in the meantime.

  57. Laurataron 23 Jul 2011 at 5:52 pm

    carykoh wrote…

    “So here’s the rub with CAM, say I have patient with low back pain. That’s difficult to treat. I’ve tried conventional, and it hasn’t helped them. They ask about acupuncture. I tell them that there’s no evidence that it helps, but some patients report a subjective benefit to it. We decide that a subjective improvement is better than no improvement. Patient goes to acupuncturist. Acupuncturist does their thing, patient feels better. Acupuncturist then suggest that they can treat their asthma, or hypertension, or whatever. Is that acceptable?”

    Not in the slightest….what is necessary in your communication to the patient is CAM is not a replacement for proven conventional medicine for condition where failure to control the underlying pathologic process may lead to dire consequences….so no, I would no recommend CAM for the treatment of hypertension, where failure tocontrol the underlying process increases the risk of cardiovascular and renal disease, or of asthma, where failure to control airway inflammation can lead to sudden respiratory failure…..conversely, if a patient with asthma, who was being managed appropriately for their asthma, expressed a desire to see a practioner of Reiki, of have their congregation prayer on his or her behalf, while I would explain that I cannot think of a sciewntific reason why that would be of benefit, that I am not going to be obstructive…..

    Keep in mind, that as a physician, I am not a “gatekeeper” to CAM…if someone is set on using CAM, and I have nothing further to offer, I think my job is to minimize harm by advising them of the scientific non-validity of CAM, and steering them away from potentially hazardous CAM…in the end, its better to remain part of the patient’s care than to alienate them, which may make them more susceptible to suggestions by unethical CAM providers…..

    as for “recipe for disaster”….I’m referring more to disease processes that are purely disorders of perception and of pain….where there underlying cause of disease is either known, or so poorly characterized that effective therpaies directed at the root underlying pathophysiology are yet to be developed…of course, I am 100% in favour of further research to better delineate these processes, and for the development of pharmacologic and non-pharmacologic therapies directed at these mechanisms….but until that day, subjective improvement for these conditions are the goals of therapy. and when we reach the limits of effectiveness for the therapies that we do have, I have little issue with trying to capture any further improvement the placebo effect may offer….

    Lastly, perhaps we can refocus the discussion a bit….. I understand the resistance to using CAM, even to harness a placebo effect….so can anyone propose a way that this effect can be tapped without resorting to CAM…..I know for certain patients, I can provide anodyne advice about changing diet or exercising more, that of course have numerous health benefits, even if not for IBS or fibromyalgia, and this may provide placebo benefits for those who believe (or can be suggested to believe) the healing power of diet and exercise….any other ideas?

  58. Mlemaon 23 Jul 2011 at 5:53 pm

    Dr, Novella says:
    “If your belief system cannot survive close or open scrutiny, if it cannot compete in the rough and tumble world of free information, perhaps it is lacking in some fundamental way.”

    What does this mean Dr. Novella? Belief in spaceships and aliens? Belief in God? Belief in the supernatural?
    Or are you talking about supposed scientific beliefs, like whether or not vaccines cause autism? Or that magnets help arthritis?
    Or is it all the same to you?

    I don’t really see “competing in the rough and tumble world of free information” as being equivalent to “surviving close or open scrutiny”. People gravitate to the information that appeals to them. Only the people who are already critically-minded will take advantage of skeptical web sites to analyze all the info they find about any given topic. But I don’t really see too many Skeptic sites analyzing scientific info in such a systematic way. (there are exceptions :-)

    I find everyone’s comments here most insightful and agree with them all. If a skeptic hopes to overcome ignorance and fraud through online information, the information needs to be packaged in a “non-denominational” kind of way (for lack of a better description). if you want to criticize religion – do it over here. And if you want to expose a fraudulent product, do it over here. Otherwise, the mish-mosh of beliefs that most people tend to be made up of will prevent them from getting at the salient info you’re trying to provide.

  59. Mlemaon 23 Jul 2011 at 5:58 pm

    Damn, posted on the wrong page! Please disregard comment immediately above! SORRY!

  60. Laurataron 23 Jul 2011 at 6:03 pm

    at SteveA….

    Sure….I wish everyone would give more money to charity…..i’m sure everyone has at somepoint is wasteful spending or unnecessary consumerism that could have been more charitally directed….

    and if someone had a value system through which healing could be achieved through charitable donation, that I would have no problem with a patient following this course (of course though, only as in addition to proven evidence-based therapies)….

    So then, where are we at for the people who don’t believe that a charitable donation will improve their fibromyagia symptoms?

    Laura

  61. SteveAon 24 Jul 2011 at 3:08 pm

    Lauratar: “So then, where are we at for the people who don’t believe that a charitable donation will improve their fibromyagia symptoms?”

    We could…tell them the truth?

    That there’s nothing that science-based medicine can do for them at present, but more funding might help find better treatments in the future.

    The alternative seems to be to pour money into the pockets of quacks and charlatans who are in the business of selling false hope to desperate people. False hope is no hope at all.

    I might be selling a false dichotomy here, but I can’t see a middle way. Either a treatment is supported by science or it’s not.

  62. Nikolaon 24 Jul 2011 at 6:11 pm

    @ carykoh on 23 Jul 2011 at 3:55 am

    The whole thing seems outrageous to me, allowing someone to feel better without objectively changing their illness? Recipe for disaster.

    +1

  63. Laurataron 24 Jul 2011 at 8:46 pm

    SteveA wrote….

    “That there’s nothing that science-based medicine can do for them at present, but more funding might help find better treatments in the future….”

    I agree….I’ve told many a patient this, or something similar….I think it is important to tell patients when all evidence based options have been tried and exhausted…..

    I think the crux of the issue is:

    1) Is the “placebo effect”, through which inert therapies can promote positive changes in subjective perception of symptoms, a true phenomenon, or merely a function of trial participation, and

    2) If so, is there a feasible way we can assist our patients in accessing this effect to their benefit…

    I agree with you wholeheartedly that most CAM is not science-based, or at most, is based so loosely on science as to become easily untethered, and I do wish that there was a way that money could be kept out of the hands of its practitioners…..yet, as a believe that there the placebo effect is a real phenomenon, and patients do appreciate any subjective improvement that leads to improvement in function and QoL, how do you propose how we can assist patients in accessing it…

    Of course, if you believe that the placebo effect is not real, than its a moot point……

    Laura

  64. Nikolaon 24 Jul 2011 at 9:42 pm

    @Lauratar on 24 Jul 2011 at 8:46 pm

    I think it is important to tell patients when all evidence based options have been tried and exhausted…..

    The problem isn’t merely the fact of recommending an option that isn’t evidence based – e.g. an experimental therapy with insufficient data behind it. The crux of the problem is recommending options that have been studied scientifically and not only lack evidence of efficacy, but there’s heaps of evidence against their efficacy (for example homeopathy).

    Instead of referring your patients to CAM practitioners, why not recommend some type of exercise, swimming or jogging, or relaxation activity, while *truthfully* implying that it will help with their general health and, possibly, with the specific symptoms that are bothering them currently. The placebo effect (however you envision it) will be there, the activity will be beneficial instead of useless (or worse than), and belief in woo will not be promoted.
    How would such a recommendation fail to harness your idea of a placebo effect?

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