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CAM: The Beer Goggles of Medicine

It is summer, the kids are off, and time to write dwindles in the face of sun and golf. Nonsense knows no season, and in my readings this week I came across the phrase “the undeniable power of the placebo.” I will do my best to deny that power at least three times before the I crow my conclusion.

One of my first entries for SBM, back in the mists of time, was the Placebo Myth [0], where I argued that the placebo has no clinical effects, has clinically irrelevant alleged physiology and at most leads to a slight change in perception on the part of the patient that they have less pain. Essentially placebo does nothing. It has no power.

Two studies this month continue that argument: demonstrating that placebo has no practical benefit and the crowing in the media mistakenly trumpets that it does. The headline on Medscape [1] reads “Placebo Effects Modest in Treating the Common Cold.” How modest?

719 patients with new-onset common cold were randomly assigned to no pills, placebo, blinded to echinacea, and open-label echinacea. Illness duration and severity were the main study endpoints, and neutrophil count and interleukin 8 levels from nasal wash at enrollment and 2 days later were secondary endpoints.

No surprise that for the hard endpoint, WBC and interleukin levels, the sciencey part of the study, there was no difference. Placebo and echinacea (as if there were a difference) had no effect on measurable reality.

There was no difference in the severity scores in any of the groups as well.

Those who thought they received echinacea thought they were better faster (2.58 days, not statistically significant) than those who did not know they were getting echinacea. As is usual with CAM studies, only when the patient believed they were getting a potentially effective treatment did the subjective aspects of their illness improve.

The authors said “Participants randomized to the no-pill group tended to have longer and more severe illnesses than those who received pills.” What was the difference between 3 placebos and no treatment over an illness that lasted a week?

The difference was 0.16 days. Two decimal points. That’s accurate. That would be 3 hours, 50 minutes, and 24 seconds faster improvement. Seriously. That is a clinically relevant number? Is there anyone who can mark both the onset and end of a cold with that kind of precision? Over a week they improved 2.2% faster. That is modest. Is such an ‘improvement’ likely to be a real effect or part of random clustering seen in all studies?

So another study that demonstrates that the only effect of placebo is to change the perceptions of illness, not the illness itself. Placebos of all kinds, and all CAM is placebo, do nothing for objective findings, only change the perception of diseases. It is a curious phenomenon. If someone’s perceptions convince them that they were abducted by aliens, or see ghosts, or witnessed a UFO, or psychic phenomena, many would say, and rightly so, that perceptions are unreliable and that they are being misled and misinterpreting what has occurred. If the same thing happens with SCAM, we fund studies by the NCCAM.

The second study was the NEJM asthma report, already discussed at length at this blog. Patients with mild asthma had no objective changes in their lung function, but were subjectively better if they had a placebo inhaler or sham acupuncture when compared to no treatment. Again, no objective change, only subjective change.

If a patient says they are subjectively better, then they are better even if they are objectively unchanged, right?

It is an interesting question, almost a Zen kōan, like the sound of one hand clapping, or if a tree falls in the forest and no one is there to hear it, does it make a sound? [2] If there was an overarching theme to TAM 9, it was that humans have an amazing ability to convince themselves that phenomena that have no basis whatsoever in reality are in fact real. It may be UFO’s, or ghosts, or psychic abilities or libertarianism [3]; people believe these phenomena are real but they are only fooling themselves. The placebo effect is not an effect, but only a change in perception.

Illness appears better through the beer goggles of placebo and CAM. But in the morning, when you wake up, the disease is unchanged.

Virtually all SCAMs have no effect beyond that of placebo. So I hereby declare a new law: Since SCAM effect = placebo and placebo effect = nothing, therefore the SCAM effect = nothing. Lets call it Crislip’s Law of the CAM Transitive Relationship ™, as I do so want something named after me, and, as homeopathy founder Samuel Hahnemann demonstrated, by declaring a random concept a Law, it imbues it with a fundamental validity. Get it on the Wikipedia this week, OK?

Both the AFP and NEJM have the same duh moment: these studies “support the general idea that beliefs and feelings about treatments may be important and perhaps should be taken into consideration when making medical decisions.”

Of course it is important to take into consideration the patient’s beliefs and feelings when treating them. The more involved the patient is with their treatment plan, the better the outcome. A huge part of the practice of medicine is just that interaction. After 25 years, most of the time my practice is not that difficult.   Most consults would take at most 15 minutes from start to finish if only my clinical needs were the issue: Me find bug, me kill bug, me go home. It is really not that hard anymore. The time in a consult is not in making the diagnosis and starting the treatment plan, it is talking with the patient and their family about all the ramifications of their diseases.

The NEJM article, however, bordered on the ludicrous. Most busy clinicians do not have the time or inclinations to read most articles critically. We rely on a hierarchy of trust, and know from prior experience that some journals are more trusted than others. The Annals of Internal Medicine lost my trust years ago, and I always read their articles with a grain of salt substitute, knowing that they can publish gullible nonsense. First the acupuncture article, now the current asthma article, and the NEJM has fallen from trusted journal to one I must read with suspicion. I long ago was taught that you judge a person by the company they keep, and the NEJM has now been frequently spotted in the company of nonsense.

Look at the abstract, which is all most people will read:

Although albuterol, but not the two placebo interventions, improved FEV1 in these patients with asthma, albuterol provided no incremental benefit with respect to the self-reported outcomes. Placebo effects can be clinically meaningful and can rival the effects of active medication in patients with asthma. However, from a clinical- management and research-design perspective, patient self-reports can be unreliable. An assessment of untreated responses in asthma may be essential in evaluating patient-reported outcomes. (Funded by the National Center for Complementary and Alternative Medicine.)

Placebo effects can be clinically meaningful. You are receiving a SCAM based/placebo based therapy. You think you are better. Your tumor, your HIV, your rheumatoid arthritis, your asthma is unchanged and the basic pathophysiology, with its physiological consequences, metastasis, immune destruction, joint damage, lung inflammation, continues unabated and unchecked. That is good?

The accompanying editorial has what has to be the most dumbass straw man in the history of the NEJM:

What is the more important outcome in medicine: the objective or the subjective, the doctor’s or the patient’s perception? This distinction is important, since it should direct us as to when patient-centered versus doctor-directed care should take place.

I am rarely insulted by the SCAM world; mostly I roll my eyes and give a snort of laughter. However, this is the NEJM, an allegedly respected journal.

The goal of medicine always has been and always will be about both. The heart of patient care is establishing a therapeutic relationship, and everything that is the placebo ‘effect’ is part of the interaction between patient and health care worker. To suggest otherwise is both disingenuous and insulting. The issue for as long as I have been in medicine is the best way, within time and financial constraints, to apply and nurture the non-objective parts of medicine. What is not needed is to wrap up the patient-physician interaction in pseudo mystical nonsense, lies or non reality based therapies that are SCAM.

Maybe it is sufficient simply to show that a treatment yields significant improvement for the patients, has reasonable cost, and has no negative effects over the short or long term. This is, after all, the first tenet of medicine: “Do no harm.”

They are advocating for a form of Fernando medicine: it is better to feel improved than to be improved.

I suppose not being effective is not considered a ‘negative effect over the short term or long term.’ And I always though the first tenet of medicine was “Heal the patient.” If you can to that without harm, so much the better.

A positive subjective response plus no objective response yields nothing.

A negative subjective response plus a positive objective response yields a suboptimal clinical outcome.

A positive subjective response plus a positive objective response yields the best of clinical outcomes. It is what we, in real medicine, strive for.

SBM at its best offers the last, SCAM at its best offers only the first. It offers nothing but beer goggles.

Footnotes

  1. Have I really been writing for this blog for over three years? Where does the time go?
  2. I am a paid Infectious Disease blogger for Medscape, and I realized during an interview with Rachael Dunlop that since Medscape is supported by pharmaceutical advertising, and I am paid by Medscape, I am, in fact, a paid Big Pharma Shill once removed.
  3. We know from the work of Elliot and Goulding that in fact it does not.
  4. The last is a joke. Please, do not send me copies of the Watchtower in an attempt to convince me of the righteousness of your cause.

Posted in: Clinical Trials, Science and Medicine

Leave a Comment (47) ↓

47 thoughts on “CAM: The Beer Goggles of Medicine

  1. windriven says:

    This, from the same paragrpah in the NEJM abstract:

    “… albuterol provided no incremental benefit with respect to the self-reported outcomes.”

    “… self-reports can be unreliable.”

    Therefore, and by their own admission, the text of the article that followed is unalloyed bullwhip.

    * * *

    “What is the more important outcome in medicine: the objective or the subjective…”

    Ummm, I think it is arguable that the avoidance of death and morbidity is the only outcome in medicine that matters.

  2. woo-fu says:

    My subjective impressions regarding albuterol is that it does make me feel better–gee wiz, it helps me breathe! And it certainly helps objective measures of lung function. For me that’s a big med win.

    However, I have heard at least one medical professional tell me if I could just reduce my stress, I probably wouldn’t need the albuterol “as a crutch.” This seemed to imply the problem was with my mindset, not my lungs, and the “crutch” comment just implied I was weak in this person’s view. When I mentioned this to my immunologist he just rolled his eyes and groaned.

    Of course, stress can make asthma worse, but lack of stress doesn’t objectively cure the condition, either. I work on my stress, but I think I’ll keep my “crutch” thank-you-very-much SCAM doc.

    @Mark Crislip HCW? I’m guessing that’s for Health Care Worker?

  3. @woo-fu

    I could not help but respond to this. I loathe the myth that the right lifestyle will magically lead the body to snap back into place and start working right. The understanding of disease pathologies is an ever evolving science. If there was a simple lifestyle modification people could do that would lead to that significant of an outcome, wouldn’t it have been noticed by now? Some people have been watching too much Patch Adams.

    Stress is everywhere in life. It is unavoidable. To tell a person that they “wouldn’t need so much of Medication X if they just chilled out more often, geez, man” is so preposterous and angeringly ridiculous I don’t even know how to respond when I hear that other than to start foaming at the mouth.

    Sometimes, I wonder if people would feel as “stressed” if they stopped worrying so much about preventing this mysterious, vague demon named “stress” and just accepted that sometimes life is just difficult and you have to work through it. Or maybe…just maybe…diseases happen anyway and sometimes there are no perfect solutions so you do the best you can with what you have?

    Of course, feel free to correct me if I am off base here. I mean that. =)

  4. pmoran says:

    Whoa! It is stating the obvious to say that placebo medicines have, in general, no effect on disease processes, but it is another thing altogether to imply that they are of no value at all to those using them. There is also a lot more scientific information on placebo/sham treatments than is ever discussed here.

    In the NEJM article that you quote, Mark, the graphs suggest that placebo responses were responsible for about 80% of the overall subjective responses to albuterol, and that the placebo groups felt substantially better than the untreated group. Is that “doing nothing”?

    Similar results, with effect sizes of up to 0.6 or better have been obtained with sham acupuncture for chronic back pain, a condition where the mainstream has no very effective treatment.

    That would be a better example for consideration, since CAM and placebo medicines are mostly resorted to where conventional medicine is weak.

    http://archinte.ama-assn.org/cgi/content/abstract/167/17/1892
    http://archinte.ama-assn.org/cgi/content/abstract/158/20/2235
    http://www.ncbi.nlm.nih.gov/pubmed/15838072

    Of course, such results may well be partly due to patient reporting bias or gung-ho approaches in the researchers ( even Ernst?). We have no way of measuring those. We can say that what patients say about their responses is consistent with what we know about human perceptions and their sensitivity to suggestion and suggest that subjective responses are not necessarily less valuable for being altered perception.

    I have no particular brief for placebo, or CAM, or for placebo medicines. I simply find the science unclear. I waver between accepting that they don’t do much in general, while also seeing them as having considerable potential in certain settings and perhaps sometimes being wiser than more risky therapeutic options.

    It depends upon which evidence and which clinical settings I am considering at the time.

    I say again that the science is not yet clear.

    1. Harriet Hall says:

      @pmoran,

      I don’t think anyone is saying placebos “are of no value at all to those using them.” Value is subjective. People who smoke perceive value in smoking. Obviously people who feel better after taking a placebo perceive a “value” to taking it. The problem is that the perceived value may not be truly in their best interests, and subjective improvement without objective improvement can harm patients in conditions like asthma. Improvements with placebo tend to be of small magnitude and short duration. Feeling better temporarily may be offset by feeling worse when the placebo stops helping and false hopes collapse. And the patient/physician relationship can be undermined.

      I was originally very sympathetic to your position. I saw you as a wise, kindly clinician whose goal was to help patients feel better by any means available, who did not condone lying to patients but who was occasionally willing to bend the rules for the patient’s benefit. Now you are going too far. Now it seems to me you are willing to break the rules and to adopt a paternalistic authority over the patient. If you take the responsibility for deciding that a placebo is “wiser than a risky therapeutic option,” you are interfering with the patient’s autonomy, and that should not be done lightly. I can accept breaking the rules, but only in special cases and only with twinges of conscience. Our primary duty is to our patient’s eventual welfare, and pursuing short-term feel-better goals may not be in the interests of long-term welfare.

  5. woo-fu says:

    @nobodyyouknow

    Not off base, by my account! ;) Actually, I wish I’d had those words to use at the time. Instead, I just went a bit slack-jawed, and when I did respond–well, I wasn’t foaming at the mouth, but I was off-kilter enough for my reaction to be taken as confirmation of the stress to the SCAM doc. ARRGH!

    @Mark Crislip

    Dr. Crislip, you note that the most time-consuming aspects of the medical practice have to do with patient education, regarding their diagnoses, medicines, etc.; I’m wondering if PAs and nurse practitioners help in this regard. I ask because I’ve met a few doctors who stay mainly focused on that 15 min diagnostic, skipping over the more time-consuming education part. It seems that if they don’t have the time to do the educating, they should have someone on staff to do it for them.

    I asked one doctor to help me make sense of info coming from various specialists and was told, “That’s not my job.” When I asked about medications, I was told, “That’s what the search engines are for.” Obviously, I dropped that doc, but there does seem to be a change in the way our local GPs handle patient education, especially in the very overworked doc-in-a-box establishments.

    I see this as a major problem. Although, I can slog my way through medical journal articles, I’m no doctor. It’s very easy to get confused without the medical background. That’s why I turn to blogs like this one.

  6. SloFox says:

    @woo-fu

    I asked one doctor to help me make sense of info coming from various specialists and was told, “That’s not my job.” When I asked about medications, I was told, “That’s what the search engines are for.” Obviously, I dropped that doc, but there does seem to be a change in the way our local GPs handle patient education, especially in the very overworked doc-in-a-box establishments.

    You did the right thing in seeking a new GP. There’s really no excuse for that. As Dr. Crislip rightfully points out the art of medicine lies in developing an appropriate therapeutic relationship with your patient. This is something that is (perhaps increasingly) lacking but paramount to being a good physician. Unfortunately, tests and procedures are disproportionately reimbursed when compared to time spent engaging the patient.

    @Dr. Crislip

    Very good article. What some might say, however, is that for conditions in which therapies are limited or have been exhausted (uncomplicated LBP, headaches, fatigue) why not try placebo? For me, it’s a question of ethics. I think any form of dishonesty, even when motivated by trying to help the patient, undermines the trust implicit in the doctor-patient relationship. Physicians must be paternalistic at times but deception in the name of paternalism is anything but patient-centered.

    I’d be curious to hear your thoughts.

  7. @woo-fu

    “I was off-kilter enough for my reaction to be taken as confirmation of the stress to the SCAM doc. ARRGH!”

    I have to admit, when I read that line, I immediately thought of this episode of South Park (one of the smartest shows on TV if you can get past the raunchy humor) where people peeing in the pool eventually destroys a water park. “Scientists” were called to investigate the effect of urine on sanity, using monkeys as a test subject. When the monkeys were sprayed with urine, they became enraged and physically antagonistic, which the scientists used as evidence that exposure to urine causes insanity.

    I thought this was a brilliant analogy to the hole these experiences with belief-based medicine gets the patient into. A cycle of confirmation bias that a bad attitude causes disease, which causes a worsened bad attitude, ultimately creating a negative feedback loop that does nothing to build a therapeutic relationship between the provider and the patient. Of course, nobody likes to be pissed on! Duh!

  8. JPZ says:

    @Mark Crislip

    Seriously? On one hand you talk about patient subjective improvement in symptoms for common cold or asthma and compare it to non-clinical but subjective improvement in perception of HIV/AIDS and cancer. Poison The Well much? If the outcomes of the cold and asthma studies have no clinical significance, stick with that. That is something I hope we can all appreciate and understand.

  9. BillyJoe says:

    “The last [libertarianism] is a joke.”

    Every joke is built on an element of truth ;)

  10. woo-fu says:

    @JPZ

    Dr. Crislip’s argument didn’t read like a “poison the well” fallacy to me. Perhaps you could explain further?

    If his argument was directed at a person, for example the individuals conducting the placebo study, and he suggested that those individuals would inevitably use placebo for more terminal conditions, that could be a straw man. But his argument didn’t come across to me that way either.

    To me it seemed he was pointing out the potential dangers of encouraging physicians to prescribe placebos in general and where unfounded faith in placebos could lead. Asthma can be deadly, so treatment with placebo is very concerning to say the least. Apparently, this fact is getting overlooked, especially by the MSM. Through a comparison with AIDS and cancer he simply further illustrates the absurdity and danger of “medicating” with placebo to a degree that it cannot be overlooked.

    I could be completely wrong about this as I cannot read Dr. Crislip’s mind, but that’s how the argument seemed to flow from my perspective. I also have yet to have my first dose of caffeine this morning, so I may not be seeing the issue the way you do.

    @nobodyyouknow

    Which season/episode was that? It sounds like I missed a good one!

  11. woo-fu says:

    @SloFox

    Unfortunately, tests and procedures are disproportionately reimbursed when compared to time spent engaging the patient.

    Good point! That’s another reason I wonder if physicians’ assistants and nurse practitioners could be of more help here.

  12. pmoran says:

    Now you are going too far. Now it seems to me you are willing to break the rules and to adopt a paternalistic authority over the patient

    Harriet, there are wider issues than what mainstream doctors might choose to do in relation to placebo-type medicines. I am inclined towards a less overbearing medical profession in that wider context.

    Also, is not your “– the perceived value may not be truly in their best interests” a paternalistic judgement? We doctors can’t help being a bit paternalistic, but in a good way, can we?

    In the meantime there are matters of scientific “truth” and “clinical value” to resolve. We cannot have some skeptics attributing certain observations to “placebo effects” while others contend, like Mark, that “the placebo has no clinical effects”.

    Medicine is a humongous patchwork quilt of clinical settings, some of which are under the direct control of doctors, some not. In some of the latter placebo influences may be very important, needing to be looked at alongside other matters such as the recent suggestion that chronic use of NSAIDs doubles mortality in the elderly.

    I guess my concerns are fueled by the failure of this group to, even after three years, outline clear objectives in relation to CAM. Anyone reading Mark’s piece with its rejection of placebo influences and reference to “sCAMs” would assume that the ultimate objective is to deprive the public of any access to anything other than FDA endorsed medicines.

    Everyone says they don’t intend that, but if they don’t, they should watch their rhetoric. I don’t want good science-based skeptical opinion to become more marginalised than it already seems to be in some respects.

  13. Harriet Hall says:

    @pmoran,

    ” is not your “– the perceived value may not be truly in their best interests” a paternalistic judgement?”

    No. If a patient perceives value in smoking, it is not paternalistic to say that smoking is not in his best interests. If a patient perceives value in subjective improvement of asthma but has no objective improvement and is in danger, it is not paternalistic to try to protect him from respiratory failure.

    “the ultimate objective is to deprive the public of any access to anything other than FDA endorsed medicines.”

    No, the ultimate objective is to provide accurate information so patients can make informed decisions.

    I support the right of patients to use any treatment they choose. I support the duty of doctors not to prescribe placebos or to misrepresent ineffective or untested treatments to patients as certain to help or scientifically proven.

  14. Harriet Hall says:

    @pmoran,

    “placebo influences may be very important, needing to be looked at alongside other matters such as the recent suggestion that chronic use of NSAIDs doubles mortality in the elderly.”

    If you can show evidence that placebos can effectively replace NSAIDS and reduce mortality, I’m listening.

  15. jre says:

    Anyone reading Mark’s piece with its rejection of placebo influences and reference to “sCAMs” would assume that the ultimate objective is to deprive the public of any access to anything other than FDA endorsed medicines.

    Everyone says they don’t intend that, but if they don’t, they should watch their rhetoric.

    There seems to be a wide gulf in perception here. I suspect I am not alone in thinking that the “ultimate objective” of this and similar pieces is to persuade as many people as possible that if a drug or a therapy works no better than a placebo, then in a real and meaningful sense, it does not work. If I’m right about that, then I’ll take the extra step and say that such persuasion is not depriving the public of anything, any more than successful anti-smoking campaigns have deprived the public of cigarettes. I get the impression that pmoran feels that if a patient fools himself into feeling better, than it is harmful and unethical to unfool him. An interesting philosophical point, to be sure, but I see no reason why those who hold otherwise should be in danger of becoming “marginalised.”.

  16. Lauratar says:

    @Harriet….

    so would there be any issues with using a placebo (assuming one had a way to administer a placebo) be ethical for a disease that is purely a disorder of perception….as an example, fibromyalgia?

    Or in using a placebo to supplement maximal EBM treatments where residual subjective symptoms are present?

    Laura

  17. Lauratar says:

    @Harriet….

    so would there be any issues with using a placebo (assuming one had a way to administer a placebo) for a disease that is purely a disorder of perception….as an example, fibromyalgia?

    Or in using a placebo to supplement maximal EBM treatments where residual subjective symptoms are present?

    Laura

  18. A solely subjective impression of improvement (placebo) can be a pyrrhic victory. At least in the context of the kinds of stubborn pain problems I know best, placebo effects tend to backfire: the patient is betrayed in the end, and the failure to achieve a lasting cure paradoxially cements the patient’s idea their pain is untreatable, “even by acupuncture” (for instance).

    Working as a Registered Massage Therapist, I routinely saw this. Pain patients in general, and low back pain patients in particular, are already strongly predisposed to anxious assumptions that their problem is “really bad.” When the placebo effect of acupuncture wears off, as it must, this anxiety is reinforced and the pain is elevated to the status of a fiercer enemy.

    A nice trap. Real harm gets done this way.

    Plug: I describe this phenomenon in more detail in my (science-based, skeptical) book about low back pain.

  19. JPZ wrote: “If the outcomes of the cold and asthma studies have no clinical significance, stick with that.”

    What a puzzling admonition. We should not think and write about the implications? We should not question and challenge the breathless portrayal of placebo as “powerful” when the evidence says otherwise? The NEJM can credulously editorialize, but we must restrict ourselves here to reporting only the experimental results?

    No deal!

  20. JPZ says:

    @Paul Ingraham

    A subjective improvement in symptoms of the common cold or mild asthma attacks can be clinically significant in that the discomfort is transitory, and the self-perceived comfort of the patient during that period has value as a treatment modality. If a placebo leaves a patient feeling great but causes them to ignore treatment of the underlying condition of HIV/AIDS or cancer, then it has no use as a treatment modality. The same physiological effect has great value in one condition and no value in another. If, in this case, the treatment has no value in transitory conditions, then you have assigned it null value as opposed to conditionally beneficial. Thus my “stick with that” comment.

    I think I understand your point a bit better thanks to your post. If Mark’s point was to challenge NEJM’s hyperbole with equally over the top comparisons, then my comparison to “poisoning the well” did not capture the intent. My bad.

  21. elmer the fake nutritionist emailer not says:

    It occurs to me that I’ve spend a fair amount of time on message boards frequented by chronic pain sufferers, and I’ve seen people say acupuncture seemed to work for them, and others say it didn’t work for them, but the one thing I have never ever seen is someone say, “even acupuncture didn’t work,” and thus they give up. I suspect this may be the equivalent of Reagan’s welfare queen or Cheney’s ticking time bomb.

  22. elmer the fake nutritionist emailer not says:

    … I was thinking “medical equivalent” as I typed, but somehow the word didn’t reach my fingers…

  23. yes pomran you are right that that is a better example for consideration, since CAM and placebo medicines are mostly resorted to where conventional medicine. please not that one of your link num 2 is not working.

  24. pmoran says:

    There seems to be a wide gulf in perception here. I suspect I am not alone in thinking that the “ultimate objective” of this and similar pieces is to persuade as many people as possible that if a drug or a therapy works no better than a placebo, then in a real and meaningful sense, it does not work.

    This is the standard skeptical mind-set, to which I also once subscribed. It seems so obvious, doesn’t it? Everyone keeps saying it. It is what we have always assumed.

    In fact, “working better than placebo” only tells us that a remedy possesses intrinsic medical activity.

    It tells us nothing whatsoever about the placebo. We can, on other kinds of evidence, deduce, or predict, that placebos don’t affect most objective disease states.

    We have to look at other kinds of evidence, too, in order to find out what the placebo, when embedded within all the other psychogenic influences of medical interactions, is capable of, under suitable conditions and with responsive complaints.

    I contend that contrary evidence is never examined here and that it is not reassuring for a bald “placebo does not work” stance.

    Don’t take my word. Go and look for yourselves.

    More later.
    .

  25. Donna B. says:

    I think it’s sort of dumb to be comparing the physiological results of smoking a cigarette to the non-physiological results of taking a placebo.

    The action of swallowing or inhaling and then expecting something to change IS the placebo effect. What the asthma study showed was that it is purely subjective. That doesn’t mean the action isn’t important. If it weren’t nicotine patches would work much better.

  26. Harriet Hall says:

    @lauratar,

    “would there be any issues with using a placebo (assuming one had a way to administer a placebo) be ethical for a disease that is purely a disorder of perception….as an example, fibromyalgia?”

    I have an issue with it. Medical ethics prohibits lying to a patient. That should be the rule. I can condone occasionally breaking the rules, but only with very good reasons and with a twinge of conscience.

    If you can figure out a way to offer a placebo without lying, that’s OK by me. You might say “Homeopathy is not scientifically plausible and has been scientifically shown not to work, but some people do believe it has helped them. If you want to try it on the basis of unsupported belief or in the hopes that you might have a placebo response to it, I have no objections.

  27. Harriet Hall says:

    @Donna B,

    “I think it’s sort of dumb to be comparing the physiological results of smoking a cigarette to the non-physiological results of taking a placebo.”

    Who did that?

  28. Calli Arcale says:

    woo-fu:

    However, I have heard at least one medical professional tell me if I could just reduce my stress, I probably wouldn’t need the albuterol “as a crutch.”

    I think if a medical professional told me that, I might ram my albuterol inhaler up his nose. Well, not really. I’d make a complaint to his employer and/or the board instead. It is true that asthma sufferers need to learn their triggers, and that avoiding these triggers is helpful. However, not all triggers can reasonably be avoided (and if stress is a trigger, then you’re going to have a “fun” life, because stress is part of life — it can sometimes be reduced, but never eliminated). And albuterol as a “crutch”? Implying you’re *weak* for needing it?

    Well, yeah, but that’s actually true of people who use *actual crutches* and he’d have to be a real jerk to say that to them. Actual crutches are used to relieve weight on an injured leg so that it can heal. Doctors prescribe them not because you’re too sissy but because you need to stay active without screwing up that leg any more. Same thing with albuterol. It keeps you going long enough to get the real problem dealt with. Is it a crutch? Yes. Is that a bad thing? Not at all. Neither are crutches. They’re *tools*.

    I only had to use crutches for a few weeks after a bad sprain, but it made me quite a bit more sensitive to the phrase “using x as a crutch”.

    JPZ:

    A subjective improvement in symptoms of the common cold or mild asthma attacks can be clinically significant in that the discomfort is transitory, and the self-perceived comfort of the patient during that period has value as a treatment modality. If a placebo leaves a patient feeling great but causes them to ignore treatment of the underlying condition of HIV/AIDS or cancer, then it has no use as a treatment modality.

    Of course, that is precisely the *problem* with relying on nothing more than a subjective improvement in symptoms of a mild asthma attack. One should not take even mild asthma lightly. The same subjective improvement can be obtained (and, going by the data obtained in the study, can be obtained better) from drugs that actually help the problem.

  29. Elmer has never ever seen someone say, ‘even acupuncture didn’t work.’ In contrast, I have worked with several dozen such patients over the years … and that’s just about acupuncture. The general pattern “I’m so messed up that even _____ didn’t work” is one of the top ten themes in my inbox today.

    I have also, for that matter, had many conversations with a few actual acupuncturists troubled by their own lack of efficacy. Naturally, they always rationalized a reason to carry on, usually something about the awesome “power” of placebo …

    It is common for pain patients to “try everything,” to go through the therapy grinder, proceeding from one therapy to the next, the fear that they are untreatable growing in proportion to their hopes and expectations. Ironically, those with lower expectations tend to have less dramatic placebo effects, and are far more likely to avoid or break out of this vicious cycle, concluding that the treatment were simply useless. But for those who go into the therapy grinder with high hopes experience both more striking placebo effects, and more severe despair when they inevitably wear off.

  30. woo-fu says:

    @Lauratar

    “would there be any issues with using a placebo (assuming one had a way to administer a placebo) be ethical for a disease that is purely a disorder of perception….as an example, fibromyalgia?”

    Funny, you’d think that if placebo would work so easily for fibromyalgia, then I’d have found a fix a long time ago. Not even prescribed narcotics helped. Oddly enough, only gabapentin or a close derivative will do any good at all. A very low dose, combined with physical therapy, including massage, stretching, and a willingness to keep trying to get up again after getting completely grounded seem to help.

    A placebo pill fix–if it were that easy I’d love to try it!

    @ Calli Arcale

    Thanks for that image! If I only had Tank Girl come with me to these appointments–sigh. ;)

    The best lines only seem to come after the appointment, when I’m talking about it with someone else. That’s when I shake off the shock and think of something pithy. At least I am getting better at confronting people like this and learning to deal with them more appropriately.

  31. jre says:

    In fact, “working better than placebo” only tells us that a remedy possesses intrinsic medical activity.

    pmoran, please let me address your specific concern first, then work outward to what I think is your more general argument.
    You said earlier that any reader of Mark’s piece “would assume that the ultimate objective is to deprive the public of any access to anything other than FDA endorsed medicines” and cautioned that Mark and others “should watch their rhetoric” so as not to become “marginalised.” I objected that the goal of this and similar posts seems to be one of persuasion, and that if this is the case, then I fail to see how such persuasion, even (or especially) if it’s successful, deprives the public of anything. If I have misunderstood you, could you set me straight? How will the public be deprived?

    More broadly, I think your difference with the SBM crowd springs from differing ideas of what it means to “prescribe” or “administer” a placebo-based drug or treatment. If you say to a patient “now, this is just self-hypnosis, so make sure you believe in this pill or it won’t work”, then I think Harriet Hall and others have made it clear in comments above that they have no objection. But, you see, nobody actually does that. When patients report feeling better from placebos, they are sincere in so reporting, but they are also sincere in believing that they had received some actual treatment. And they believe it because the practitioners involved encouraged them to believe it. And, in my view, those practitioners are derelict in their duty if they deceive patients, even when they deceive themselves as well.

    Whether a “remedy possesses intrinsic medical activity” is and ought to be the only measure of whether it works. To use any other measure is to deceive your patients, and a practice built on deception is one built on sand. The first big wave of reality to come along is going to wash it away.

  32. Lauratar says:

    @ woo-fu..

    I’m not sure what I’m supposed to glean from your n=1 trial, but the point remains that in numerous bblinded RCTs, response rates for placebos are in the range of 30-50%….pregablin had a response rate of 10-30% over placebo, which means there are a fair number of people who could make a similar statement to what you just made, but substituting “pregablin” for “placebo”….

    I agree that the power of the placebo is that patient are convinced that they have a reasonable chance of getting a biologically active compound, as opposed to sugar and binders….so needless to say one wouldn’t expect giving patients tablets marked “placebo” to be particularly effective…

    However, Kapchuk et al demostrated that patients who received a placebo without deception had significant benefit over receiving no therapy in the treatment of IBS (another disease of perception)

    PLoS One. 2010 Dec 22;5(12):e15591.
    Placebos without deception: a randomized controlled trial in irritable bowel syndrome.
    Kaptchuk TJ, Friedlander E, Kelley JM, Sanchez MN, Kokkotou E, Singer JP, Kowalczykowski M, Miller FG, Kirsch I, Lembo AJ.

    Laura

  33. BillyJoe says:

    Lauratar,

    “However, Kapchuk et al demostrated that patients who received a placebo without deception had significant benefit over receiving no therapy in the treatment of IBS”

    Nope. These patients were still deceived. There was also recruitment bias. Read the methodology and see if you can spot the errors.

  34. BillyJoe says:

    …oops, Harriet has a link.

  35. JPZ, possibly the HOV reference may have been clearer if the article had been more descriptive of the health consequences of letting even mild asthma persist without treating the airway inflammation (objective symptom). Maybe this is useful.

    “Abstract
    Persistent asthma is associated to airway remodeling, characterized by structural changes of the bronchi, poorly responsive to therapies. Remodeling may strongly contribute to the residual airway obstruction observed in asthmatic patients, both children and adults, and to the loss of reversibility of this obstruction. Remodeling has been demonstrated in paediatric asthma and is not limited to longstanding severe asthma. Numerous arguments indicate that this process begins early in the development of asthma. Some studies argue for a possible prevention – or limitation – of this process by an early treatment.”

    http://www.ncbi.nlm.nih.gov/pubmed/15301800

    So when I read the HIV reference I took this as an analogy to a the problem with treating the subjective symptoms of asthma, rather than the objective obstructive inflammation that can result in remodeling. When you settle for the placebo for asthma which offer some subjective improvement, you risk a poor long term outcome for the patient with the “loss of reversibility of the obstruction”.

    Doesn’t sound like a good bargain to me.

  36. pmoran says:

    Jre, before we even get to looking at the practical and ethical side to placebos in the many and varied settings in which they are used by just about everyone on the planet there is the little matter of scientific integrity.

    This is only a blog, so that even with “science-based” in its name, some variation in opinion and modes of expression might be expected.

    That would be fine if we didn’t also almost daily lash out at others for not bothering to consult ALL the evidence, for placing biased interpretations on it, also accusing them of misusing language for presumably entirely sinister ends — entirely sinister, since not even the placebo is permitted to explain how a lot of them might simply be being misled.

    So we should be fairly sure of our science. Where that is less sure, we should play fair.

    On the practical side, the further the mainstream retreats into a strict “working better than placebo” shell (which I regard as a reasonable but perhaps unattainable objective for now), the more important it is to understand the role of placebo on the outside. For our retreat inevitably increases the demands upon folk medicine and CAM.

    If, as is highly likely, we have a society that has evolved the ability to respond to placebo, our policies and attitudes towards lay medicine should reflect that.

    We might even seek out opportunities where that phenomenon and the associated compulsive medical consumption can be gently molded so as to not only harvest whatever benefits placebo medicines can provide, but to reduce less critical demands on health care services, reducing costs as well as regrettably common negative effects of medical interventions.

    That’s just a tentative thought for me for now, but it is clear others are thinking along similar lines. I know from personal experience the humps that the skeptic has to overcome — we have a low tolerance of paradoxical human behaviour, especially involving us as supposedly science-based doctors. But it is the very science of human medical responses that contains the paradoxes.

    Remember Steve Novella’s caution about the appeal of over-simplification.

  37. woo-fu says:

    @Lauratar

    I wasn’t implying this was anything to be taken as scientific study. I was simply using my experience to illustrate that even though I did have a reasonable expectation that my symptoms would be relieved each time we tried something new, nothing helped. If a placebo were going to give me relief, I would wager it should have occurred somewhere along the line. On the other hand, by the time we tried gabapentin, I was so doubtful one might have expected a nocebo effect, but that didn’t happen either. Instead, I finally found some relief.

    Furthermore, as gabapentin works for nerve pain, perhaps there is as yet some undiscovered neurological explanation than simply a disorder of perception for fibromyalgia. For those interested please check out the following–Neurological Signs and Symptoms in Fibromyalgia: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2769083/.

  38. woo-Fu “However, I have heard at least one medical professional tell me if I could just reduce my stress, I probably wouldn’t need the albuterol “as a crutch.” This seemed to imply the problem was with my mindset, not my lungs, and the “crutch” comment just implied I was weak in this person’s view”

    This is the perfect time to let your doctor know how much paying your medical bills is stressing you out.

    :)

  39. Lauratar says:

    @harriethall

    Thanks for the link to your analysis….

    I did not mean to suggest that the paper was definitive, only that it is intriguing…..While the effect sizes are small, similar effect sizes have been used to justify the approval of other prescription medications for IBS, like tegaserod, alosetron, and likely rifaximin, if it hadn’t been for concern about the long term use of antibiotics on CDAD and other opportunistic infections….

    And while the recruitment strategy selectively enrolled patients who were open to the “mind-body” message, this likely generalizable to the population in whom you would consider to prescribe a placebo…..as an example, I am certain that I, as a clinician and clinical epidemiologist, would be fairly immune to placebo effects if I knew I was receiving a placebo or placebo equivalent, and likely would not have had any interest in enrolling in this particular study….

    The fact remains….placebo arms in clinical trials promote subjective improvement; its a real phenomenon….whether these placebo effects, however minor, can be captured effectively outside of a clinical trial, is yet to be determined……and I think before being written off entirely, are deserving of further study

    This is not homeopathy et al, which are based entirely on theories since definitively disproven or manufactured from whole cloth….I agree that “mind-body medicine” does give off an aroma of fresh woo, but there is substantial evidence on the ability of the mind and mental state to modify perception of pain and of neurologic response, which placebos in clinical trials are somehow hooking into…..

    just saying is all :-)…

    Laura

  40. JPZ says:

    @Calli Arcale and micheleinmichigan

    There are non-life threatening conditions where subjective improvement is a valid clinical outcome. Erectile dysfunction comes to mind. We cannot dismiss subjective improvement as a clinical outcome in these conditions – including the common cold. If someone cures the common cold, then palliative measures are inappropriate. If the subjective improvement is due to a placebo or a treatment no better than placebo, then the effect has clinical validity in these conditions assuming there is no other treatment that is superior. When someone uses palliative measures instead of curative measure, then that is inappropriate as well. If the disease is life-threatening, then the palliative measures are only valid if they improve upon curative measures.

    My point all along has been that comparing a condition where palliative effects are a valid primary clinical outcome to a condition where palliative effects are secondary to the primary clinical outcomes, is not an instructive comparison beyond a demonstration of hyperbole.

  41. JPZ with my parentheses “My point all along has been that comparing a condition where palliative effects are a valid primary clinical outcome (cold) to a condition where palliative effects are secondary to the primary clinical outcomes (HIV), is not an instructive comparison beyond a demonstration of hyperbole.”

    JPZ, Am I missing the part of the article you are referring to? I thought the comparison was palliative secondary (asthma) to palliative secondary (HIV, cancer, RA).

    I read MC talking about two separate studies. The cold study and the asthma study. It is in the asthma study that he makes the comparison to HIV “Placebo effects can be clinically meaningful. You are receiving a SCAM based/placebo based therapy. You think you are better. Your tumor, your HIV, your rheumatoid arthritis, your asthma is unchanged and the basic pathophysiology, with its physiological consequences, metastasis, immune destruction, joint damage, lung inflammation, continues unabated and unchecked. That is good?”

    I would agree that a comparison of cold (palliative) to HIV (palliative secondary) would be, well ludicrous.

  42. I just wanted to add (as a patient with mild asthma) how very aggravated I felt by this quote from the editorial in NEJM. “What is the more important outcome in medicine: the objective or the subjective, the doctor’s or the patient’s perception? This distinction is important, since it should direct us as to when patient-centered versus doctor-directed care should take place.”

    I am having an asthma flare that I am unaware of and the doctor detects it. How is it sane to position that situation as patient vs doctor? How is the doctor telling me something like “you asthma appears to have worsened, let’s try increasing your inhaler use to two time a day instead of as needed and recheck in a month.” doctor-centered care? Unless, of course, the editorialist believes I don’t care about getting oxygen, that I only care about whether I feel uncomfortable when I’m not getting oxygen.

    Having a doctor ignore the objective symptoms of a disease because I can not detect them subjectively is not the kind of patient-centered care I’m interested in.

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