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The Prostrate Placebo

I seem to be writing a lot about the urinary tract this month. Just coincidence, I assure you. As I slide into old age, medical issues that were once only of cursory interest for a young whippersnapper have increasing potential to be directly applicable to grumpy old geezers. Like benign prostatic hypertrophy (BPH). I am heading into an age where I may have to start paying attention to my prostate (not prostrate, as it is so often pronounced, although an infection of the former certainly can make you the latter), so articles that in former days I would have ignored, I read. JAMA this month has what should be the nail in the coffin of saw palmetto, demonstrating that the herb has no efficacy in the treatment of symptoms of BPH: Effect of increasing doses of saw palmetto extract on lower urinary tract symptoms: a randomized trial.

It demonstrated that compared to placebo, saw palmetto did nothing. There have been multiple studies in the past with the more or less the usual arc of clinical studies of CAM products: better designed trials showing decreasing efficacy, until excellent studies show no effect. There is the usual meta analysis or two, where all the suboptimal studies are lumped together, the authors bemoan the quality of the data, and proceed to draw conclusions from the garbage anyway. GIGO.

The NEJM study from 2006 demonstrated that saw palmetto was no better than placebo but it was suggested that perhaps the dose of saw palmetto was not high enough or that the patients were not treated long enough to demonstrate an effect, and the JAMA study hoped to remedy that defect.There is, as is often the case, no good reason to suspect that saw palmetto would benefit or harm the prostate. Like many herbal preparations, it had widespread uses back in the day, when I had an onion tied to my belt, which was the style at the time. You couldn’t get white onions, because of the war. The only thing you could get was those big yellow ones.., but I digress:

“It is also an expectorant, and controls irritation of mucous tissues. It has proved useful in irritative cough, chronic bronchial coughs, whooping-cough, laryngitis, acute and chronic, acute catarrh, asthma, tubercular laryngitis, and in the cough of phthisis pulmonalis. Upon the digestive organs it acts kindly, improving the appetite, digestion, and assimilation. However, its most pronounced effects appear to be those exerted upon the urino-genital tracts of both male and female, and upon all the organs concerned in reproduction. It is said to enlarge wasted organs, as the breasts, ovaries, and testicles, while the paradoxical claim is also made that it reduces hypertrophy of the prostate. Possibly this may be explained by claiming that it tends toward the production of a normal condition, reducing parts when unhealthily enlarged, and increasing them when atrophied.”

At the turn of century Edwin M Hale, MD and homeopath, wrote a treatise on the topic, extolling its benefits on the prostate and other organs. You will be happy to know that if you have testicular atrophy from being an old masturbator, saw palmetto will help. For no good reason I can find, it became popular only for BPH. As best I can determine from the internet, there was a natural medicine fad in the early 1900’s, and saw palmetto became part of the fad. No clinical trials were responsible for the use. And, like acupuncture and homeopathy, there are many explanations for an efficacy that does not exist.

The JAMA study followed 369 men for 72 weeks. They received placebo or saw palmetto twice a day, and at weeks 24 and 48 the dose of each was increased.

They were followed for subjective complaints with the AUASI score, which is a 7 question self administered questionnaire:

Well validated as a tool for BPH symptoms, it relies overmuch on memory and is subject to wishful thinking on the part of the test taker. I doubt I could ever accurately remember my urinary patterns over the prior month without writing it down.

There were also objective endpoints like peak urine flow, PSA levels, and post void residual. Makes me wonder again what they want done when the radio advertisement says ‘Void were prohibited by law.’ Would saw palmetto make that easier? When it came to the subjective measurements, there was a slight, and similar, improvements in both groups. Objective, anatomic and physiologic endpoints were not affected. No surprise. So much for the powerful placebo.

Adverse effects were the same in both groups, with the only significant difference that the saw palmetto group had more physical injury and trauma. Was this the dreaded nocebo effect, or the random badness that occurs as a result of life? Probably the latter.

Based on the JAMA and NEJM trials, it is reasonable to conclude that saw palmetto has no efficacy in the treatment of symptoms due to BPH.

More interesting is what this article says about the so called placebo effect. This is yet another article that demonstrates that for hard endpoints, altering abnormal physiology or anatomy, placebo does nothing. I bet if we did brain scans of these patients they would show changes when the patient took the medications, and to that I would yawn. Do anything to anyone, give a placebo, tickle their feet, there will be changes in the brain. And while in some studies, increasing placebo amounts and frequency leads to increasing effects, in this study an increase in placebo dose led to no improvement in subjective outcomes.

More real world data to suggest that there are no real placebo effects.

Of course, I have bias. I have spent 30 years in acute care hospitals. My patients have derangements of anatomy and physiology that, if not corrected or at least ameliorated, lead to death or permanent morbidity. Placebo isn’t going to cure endocarditis, stop a gastric ulcer bleed, or reverse a stroke. And even if the patient feels better from the therapeutic relationship, if the anatomic/pathophysiologic abnormalities continue unabated, the patient is toast.

I am not even certain it can be said that placebos cure gastric ulcers. There is little on the natural history of ulcers in the flexible endoscopy age. The only reference I could find suggests that patients who have ulcers found with x-ray screening (not a reliable way to diagnose ulcers and probably under-represented the incidence) and who are not treated had a 24% cure rate at 6 months and a 29% relapse rate at 24 months. Most of the placebo trials followed patients around 4 weeks and had a higher cure rate in the placebo wing than seen in the natural history report, but the two are not directly comparable. Given the propensity of untreated ulcers to come and go and the unreliability of symptoms for diagnosis, unless there was a study that had a treatment, a placebo, and a no intervention arm, I do not think it is reasonable to conclude that placebos ‘cure’ ulcers. Especially given the NEJM review that suggested that placebo is usually no more effective than a no treatment/waiting arm.

Perhaps it is me. I do have some intellectual blind spots, like the anthropic principal. Every time I come across it in a cosmology book, I think that it is inane. I lack the imagination, or perhaps I am not stoned enough, to recognize its significance. So too with the placebo effect.

Placebo effects are probably more like quantum mechanics. The single slit experiment gives key insights into the fundamental nature of reality, but in the macroscopic world of day to day life my electrons move about just fine to heat my house and run my computer. No need to worry about probability functions, I can throw potatoes at a slit all day and never see a interference pattern. So too with the placebo effect. Most of the practical effect is lost in the noise of the complexity of illness, especially in the acute care hospital where I spend most of my time.

As Harriet quotes Dr. Benedetti

the take-home message for clinicians, for physicians, for all health professionals is that their words, behaviors, attitudes are very important, and move a lot of molecules in the patient’s brain. So, what they say, what they do in routine clinical practice is very, very important, because the brain of the patient changes sometimes… there is a reduction in anxiety; but we know that there is a real change…in the patient’s brain which is due to… the ‘ritual of the therapeutic act.’

I do not disagree with that. I consciously try to accentuate just those interactions with every patient, because I know my job as a physician is more than ‘Me find bug, Me kill bug. Me go home’. But I do not think it is important for modifying any disease process I am involved with. Grooming each other has salubrious effects in monkeys, and as best I can tell, the placebo is no more than evolutionarily advanced nit picking.

Large swaths of the world rely on native healers and the only tool in their armamentarium is the “ritual of the therapeutic act.” And across the world and throughout time, people have suffered and died in droves. You may argue that is not a fair comparison, people suffered from poor hygiene, no vaccines, malnutrition and no health infrastructure. But the US has a group whose health care is only placebo, relying entirely on the ritual of the therapeutic act, and despite being surrounded by the benefits of western societal infrastructure, they die faster and younger: Christian Scientists.

At the end of the day, the practice of medicine is practical endeavor. I am a builder, not an architect. I have to try to make my patients better objectively and subjectively, and the placebo is a tool that has little utility in my toolbox. When my prostate grows to the size of a tennis ball, I am going to go looking for a therapy that will shrink it, not fool me into thinking I can write my name in the snow a little better.

Posted in: Clinical Trials, Herbs & Supplements, Science and Medicine

Leave a Comment (34) ↓

34 thoughts on “The Prostrate Placebo

  1. phayes says:

    The discussion in the panel part of the Anthropic Reasoning video here: http://www.phys.cwru.edu/events/cerca_video_archive.php is very entertaining.

  2. colli037 says:

    [quote]I can throw potatoes at a slit all day and never see a interference pattern. [/quote]

    but do you get decent french fries (or chips)

    t

  3. This has gotta be the best thing about the placebo that I’ve ever read. The “go to” piece on SBM.

    KA

  4. cervantes says:

    Right, but don’t throw the baby out with the bathwater. The therapeutic relationship and interaction is very important in influencing whether people take their meds and otherwise follow medical advice; making decisions that are best for the patient where there are alternatives; and getting complete and accurate information. And yes, it does make people feel better, not to mention come back next time, when it’s done right. Done wrong, and it drives people to the quacks.

    Let’s make sure we give that a prominent place among the concerns of SBM.

  5. Great post. but it will be dismissed. How? The ol’ move-the-goalposts strategy.

    “The study found no benefit from [fill in the blank]. However, the study did not use a sufficient dose. In my practice, I usually prescribe doses [multiply study dose by at least two, maybe ten].”

    This is tried ant true, and tired-out an true.

    But here is a limit of current JAMA-oriented science: this JAMA article is set up to invite the move-the-goalposts criticism. The authors have NO discussion of what the purported therapeutic dose should be. In the intro, page 1344 provdes info on the use of saw palmetto, but nothing about typical dose, or true-believer-recommended dose. At Methods>Intervention, the doses are described, but NEVER justified. Just because there are 3 levels (a great design strategy for these herbal supplment studies), does not mean that a “therapeutic dose” was used; all three could be sub-optimal.

    The other move-the-goalposts trick is: it wasn’t prepared correctly. Long ago, I read a critique of St John’s Wort-for-depression research where a true believer described how the flower needs to be harvested in spring, on the leeward side of the hill, just before full moon, etc. etc.

    In my opinion, researchers in this situation should go to the true-beliver community, and ask them to put up or shut up: tell us the dose, etc., and so if negative results emerge, you cannot then pull out the move-the-goalposts strategy. What dose? How prepared? What phase of the moon?

    Frankly, if I had reviewed this saw palmetto article, I certainly would have requested the authors to justify the dose, per true-beliver criteria, in the intro, and then reflect that in the methods section.

    Sussman and colleauges (2007 J Affective Disorders) tested the benefit of augmenting lithium or valproic acid with quetiapine for mania. But they under-powered the lithium, and the depakote:
    “In this study, mean serum concentrations of Li (0.76 mEq/L) and DVP (68.6 μg/mL) were in the lower end of therapeutic ranges. Arguably, higher levels could have yielded even more robust clinical effects than were observed in this study. However, these doses should be considered in the light of the potential for increased adverse effects interfering with assessment of the relative efficacy of quetiapine plus Li/DVP compared with mood stabilizer monotherapy.”

    No psychiatrist would feel like a MEAN Li value of .76 indicated a sufficient dose. This means only HALF of participants had entered the lower range of the therapeutic window, which will translate to clinical benefit for SOME but not ALL.

    with Li under-dosed, the quetiapine has lots of opportunity to look like it can ‘augment’ lithium. Cuz the lithium was doing nothing.

    Likewise, these herbal remedy studies need to incorporate the issue of the therapeutic dose, according to whomever it is that is advocating for the saw palmetto.

  6. qetzal says:

    The real reason this trial failed is that they stupidly increased the dose. They should have been decreasing the dose, homeopathically, to increase the potency!

    CAM is passé. All the action is in Integrative Medicine. It should have been obvious to the researchers that they needed to integrate at least two woos together – e. g. herbal folklore and homeopathy. If they were really on the ball, they’d also have administered it using acupuncture needles!

    /sarcasm

  7. CarolM says:

    Geez, I could answer 5′s to all the checklist questions, and I’m a female!

    Is there some sort of similar condition for women?

  8. LovleAnjel says:

    The questionnaire must be a test for men. I’ve never met a woman who goes two hours without needing to pee, unless she’s dehydrated.

  9. windriven says:

    @ LovleAnjel

    “I’ve never met a woman who goes two hours without needing to pee,”

    Fascinating; and yet benign prostate hypertrophy is unknown in the female population.

    ;-)

  10. aeauooo says:

    “Void were prohibited by law.”

    There was a time when you could get away with that, but now you get labeled as a sex offender – probably as the result of the efforts of lobbyists from the pay toilet industry.

    “You will be happy to know that if you have testicular atrophy from being an old masturbator, saw palmetto will help.”

    I thought it was the other way around – if you don’t use it you lose it.

  11. Daniel M says:

    Dr. Crislip,

    You might want to listen to Dr. Benedetti on the Brain Science podcast or reread Dr. Hall’s synopsis of that conversation. I’m very certain that he would disagree with your statements that this is “More real world data to suggest that there are no real placebo effects” or that “the placebo is no more than evolutionarily advanced nit picking.” Dr. Benedetti’s research is all about there being real objective placebo effects, with more specific neuronal effects than tickling someone.

    Just to be clear I am not supporting sCAM claims about placebos being wonderful healing modalities, but I believe you have either really oversimplified placebo effects by completely dismissing ANY real effect or else you have a fundamental disagreement with Dr. Benedetti’s interpretation of the research. If it is the latter I’d really enjoy reading your take, hopefully in a future full length post, on why you think the evidence does not support Dr. Benedetti’s conclusions.

  12. Mark Crislip says:

    Dr B is talks mostly about pain, a touch on Parkensons, and a little on GH. And I do not have any doubt that everything he says is true.

    In the world of acute care medicine, where I spend my time, with severe diseases, with all the deranged anatomy and physiology, there is nothing for placebo to do or can do.
    Placebo doesnt increase the FEV1 or make the prostate smaller.

    So in my world, with the exception of pain, what does placebo offer? Nothing. And he does not address those issues.

    My last consult of the day was MRSA endocarditis with multiple emboli. Just how is any placebo effect going to aid me getting the patient better? How is it going to kill the staph, stop the emboli, reverse the valve damage? It does nothing.

    He has fascinating insights of no clinical relevance. The practice of medicine is an applied science and an art of sorts. Tell me how I can use placebo tomorrow on rounds.

  13. pmoran says:

    More real world data to suggest that there are no real placebo effects.

    It is obvious that as a psychogenic influence the placebo aspect of medicinal attentions will be limited by the capabilities of the human mind.

    So there may be altered sensitivity to symptoms and ability to cope with illness, perhaps also beneficial effects upon stress levels and upon predominantly psychosomatic illnesses. We specifically expect little or no influence on most objectively measurable body functions and those many aspects of illness that cannot plausibly be expected to be under mental control..

    So finding that yet another use of placebo has no effect upon objective aspects of illness is not news. It becomes a huge straw man if it is also held to counter the main body of current placebo research and opinion.. It would have relevance mainly to some of the imaginings of “mind-body” CAM extremists.

    You have made it clear that this is a personal opinion piece, not intended to be a serious review of ALL the evidence in relation to placebo influences. So I won’t ask you to define what you mean by “real”.

  14. Daniel M says:

    Well, saying the placebo effect has no practical application in a specific setting is different than claiming it probably has no real effect. To me just you accepting Dr. Benedetti’s finding that giving a placebo that a patient thinks will stimulate growth hormone production will cause them to produce GH (as long as the patient was exposed to the real drug before) contradicts your point, which seemed to be that placebo effects were nonspecific (perhaps I read too much into your post) or your explicit claim that the placebo effect probably isn’t real. As for your point about acute care, I’m surprised you think his (and Dr. Cambell’s) extensive conversation about pain drug administration, the placebo effect, and patient expectation has no effect on critical care treatment, no clinical relevance, and isn’t something you can use on rounds.

    I’m not saying you are wrong; you obviously know a lot more than I do on the issue. It’s just that what you have presented about placebo effects not being real, not useful on the ward, and being no more an evolutionarily ‘advanced’ response than monkey nit picking contradicts most of the fundamental points Dr. Benedetti’s made in that interview. So I am hoping you’ll go into more detail on why he is wrong.

  15. Mark Crislip says:

    The specific setting where placebo is of no use is is that of trying to reverse a patients illness, not ameliorate the secondary symptoms of their underlying disease, ie treat pain. Decreasing pain is important, but like tylenol for fever, does nothing to treat the underlying process.

    99% of the time in the hospital we are primarily trying to reverse a physiologic/anatomic problem, not treat a symptom. Thats a pretty big specific setting where there is no placebo effect.

    So again, outside of pain, how am I going to use any placebo effect on rounds to make my patients better.

  16. Daniel M says:

    Dr. Crislip, My point was never that placebos are effective in every specific instance. What I was asking for clarification on was your statements that the placebo effect isn’t real and isn’t clinically relevant. To say that the placebo effect isn’t real seems to me to imply that Dr. Benedetti’s research is wrong (or at least his interpretation of it.) His research has shown that the placebo effects include responses that are specific and may or may not have some clinical relevance (the GH and Dopamine studies) and nonspecific responses that are clinically relevant (the pain studies). You say that you accept his research that has shown specific and nonspecific placebo effects, some of which are clinically relevant, yet you also say the placebo effect probably isn’t real. If that doesn’t count as a real effect than what does?

    I thought that decreasing a patient’s dose of pain killers by maximizing the placebo effect in a scientific way is not just alleviating secondary symptoms, but was also of a direct benefit to the patient by decreasing some of the side effects and complications associated with increasing opioid administration. Is my impression that decreasing pain levels while simultaneously reducing painkiller administration actually correlates with better outcomes due to a reduction in complications from the drugs? If so that would seem to indicate to me that the placebo effect is real and clinically relevant, even in critical care.

  17. pmoran says:

    So again, outside of pain, how am I going to use any placebo effect on rounds to make my patients better.

    Who in their right mind would expect an infectious disease consultant to have ANY use for placebo, even for pain? His patient’s pain would be usually be managed by other members of the medical team.

    For that matter, no doctor is under any intra-professional pressure to use placebos.

    Very many do so (mostly “impure” ones) in response to common exigencies of daily medical practice, ones that Mark would rarely experience. These can serve additional functions other than mere symptom reilef.

    Placebo influences may have to be looked upon differently again in other settings e.g. within folk medicine, CAM and in policies regarding over-the-counter medicines.

    Even pure science demands that we understand this field better, not make snap judgements from narrow perspectives.

  18. Mark Crislip says:

    What is the meaning of is?

    As to real, as I think about it, may not be the best choice of words.
    As my metaphor went, quantum mechanics is real, it just has no applicability in the macroscopic world of day to day existence.

    Similarly, while placebo effects can be shown in experimental and controlled settings, in the real world, not so much.

    When I say placebo effects are not real, except for pain, they do not have demonstrable effects on any anatomic or physiologic component of any disease that helps improve the patients health.

    I have not read the parkinsons stuff in the original, so can’t comment.

    as pmoran says “We specifically expect little or no influence on most objectively measurable body functions and those many aspects of illness that cannot plausibly be expected to be under mental control.”

    I do not know who ‘we’ is, but that is precisely what huge swaths of people think the placebo effect is. My sons 9th grade humanities teacher was telling the class that placebos are just as effective as medications for the treatment of diseases, at least as my son related it. At least it wasn’t the science teacher.

    I keep qualifying my sentences with the ‘except for pain’ clause, maybe should put it in all caps.

    At my hospitals we have had a quality initiative for post op pain control. The goal is to improve pain and decrease narc use, since narcs are dangerous. The interventions are multifactorial: polypharmacy and behavioral and educational, pre op, intra op and post op for both staff and patients. We are trying to maximize both the drugs and the interactions around giving them. Patient expectations, etc. I can’t give you the exact details, I listen to reports at the quality councils but am not directly involved with the initiative.

    Patient rate their pain control as always, sometimes and never. As a result of the intervention, we moved about a third of the sometimes into the always. The nevers? No change at about 25% of patients. These are ballpark figures from my memory.

    Despite trying to maximize the conditioning and expectations, the psychological/placebo effects on top of maximizing the best multimodal pharamacologic approach, 25% of patients never had their pain controlled and only a minority went from sometimes to always.

    It makes me wonder, in the real world, how much real effect you can expect from a placebo even for pain.

    BTW. My name is Mark. No one calls me Dr. outside the hospital, and there even rarely. I remember 30 years ago we were waiting at a restaurant and the host asked the elderly couple in front of us for their name, and loudly and with emphasis on the title, said they were DOCTOR and Mrs so and so. My wife and I giggle to this day. I only use my title on the phone as it routes me faster.

  19. Daniel M says:

    Ok, I understand what you mean better. I’ve actually seen a few people in forums use the ‘not real’ language, and usually what they seem to be saying is that placebo effects are of no benefit to the patient and aren’t physical. (Sometimes the ‘not real’ argument seems to be based in dualist and libertarian free-will assumptions that anything that is ‘just in the mind’ somehow isn’t physical or medically relevant.) “Real but not as clinically useful as most people think” does seem like a much better representation of what Dr. B said in the interview.

    I wasn’t trying to belabor the pain stuff, I was interpreting you to say that the placebo pain response was just a mask of a particular symptoms and wasn’t of much clinical importance because it didn’t fix any underlying problem, when my understanding was that decreasing pain medication during hospitalization did lead to objectively better outcomes and was important. Sorry, it looks like I wasn’t reading you right.

    Your restaurant story reminds me of a couple servers I knew who said they usually gave worse tables and service to people who identified themselves as doctor when making a reservation, because they almost invariable were the worst tippers.

  20. Mark Crislip says:

    If you are reading me wrong, I assume I am writing it wrong.

  21. Daniel M says:

    Not necessarily, I had a couple medical school tests this week and haven’t slept much at all, so I’m sure my reading comprehension isn’t what it usually is. You must be doing something right if my choice to unwind is spending time here!

  22. Mark P says:

    # pmoranon 07 Oct 2011 at 6:10 pm

    So there may be altered sensitivity to symptoms and ability to cope with illness, perhaps also beneficial effects upon … predominantly psychosomatic illnesses.

    Are you suggesting using a medicine that doesn’t work on a disease that isn’t there?

    Is there any solid reason to believe placebo medicine will help a psychosomatic illness? I’m sure it will temporarily “relieve” the illness. Without treating the real cause, won’t the patient just invent some other symptoms?

    The only thing a placebo might do is inform a doctor that the disease is, indeed, psychosomatic. Cure it, not so much.

  23. So again, outside of pain, how am I going to use any placebo effect on rounds to make my patients better.

    Prescribe antidepressants.

  24. pmoran says:

    Sorry for being slow to reply, Mark P. Your questions look simple but the subject is complex. Words can have subtly different meanings and both placebo responsiveness and its value to presponders is absolutely dependent upon context.

    So I will reply in bits. Firstly, the “wanting it both ways” thing, as exemplified here by your “it doesn’t work” — yet — “I’m sure it will temporarily “relieve” the illness”.

    I know what you mean in the context you have implied, but it was a similar kind of inconsistency that first got me to thinking critically about prevailing sceptical opinion on a few matters, placebos being one of them.

    Up until a couple of decades ago medical sceptics including myself were very happy to accept the reality and power of “placebo effects” (to use common but loose parlance). We thought they nicely helped explain and undermine many of the claims made by pseudoscientific forms of medicine, as indeed they still would.

    But then people started asking “well, so what, if these placebo medicines are helping some people — who cares how they work?”

    Well, we couldn’t have that! It just didn’t seem right to the scientific mind that ridiculous pseudoscientific nonsense could possibly be of use to anyone (and, of course, it isn’t, in one sense, any “activity” lies within the everything else to do with the therapeutic interaction).

    So, we promptly came up with reasons for believing that the placebo didn’t do that much anyway (which, again, they don’t, depending on the specific setting, and the individual, and what you consider “much”, and whose perspective you choose to adopt on the matter).

    Equally miraculously we discovered previously unconsidered ethical objections to the use of placebo which absolved us of the need for further thought on the issue.

    This is where we” are at”, as the Americans say.

    I love the fact that we in my profession can sometimes stand back from the daily turmoil of medical practice and examine ourselves with utter ruthlessness. I am not saying that all sceptics followed the above path, but I certainly did and I believe I have seen the same evolution in others and in the evolution of general sceptical rhetoric.

    Evidence recently discussed here is also suggesting that we should be revisiting the matter. Everybody seems prepared to allow that placebo effects exist, but not certain implications of that.

  25. Harriet Hall says:

    @pmoran,

    Placebos make people feel better. Fooling people works. Fooling wine customers with high priced labels makes them enjoy the wine more. It is seductive and paternalistic to think you are smart enough to know when fooling people is really in their best interests. Most of us don’t think we have the right to make those decisions.

  26. nybgrus says:

    So, we promptly came up with reasons for believing that the placebo didn’t do that much anyway

    We did? I think I am finally understanding your basis of all your arguments – you are choosing to either reject the scientific evidence and bias effects we find in studies or to reframe their magnitude to your liking (or some combination thereof). Every time you comment about CAM and placebo usage you cling with wet fingers to that continually shrinking gray area of the effect size of placebo on actual disease. And now I can understand why. You want to.

    Equally miraculously we discovered previously unconsidered ethical objections to the use of placebo which absolved us of the need for further thought on the issue.

    Do you believe in some sort of writ in stone moral code? Are you someone for whom ethics cannot change with a growing society? If so, I can recommend a few fundamentalist religions to peruse.

    Otherwise the notion that it was “miraculously” decided that placebos are unethical to use is complete [expletive.] In fact I wrote a paper last year on the shift away from paternalism in medical care starting with the civil rights movement of the 60′s, women’s liberation in the 70′s, and then medical fiascos in the 80′s where it was noted that extreme heterogeneity existed in what was considered standard of care – even between geographically close regions and when a clear science based standard of care was established.

    It wasn’t that these ethical principles “miraculously” appeared – they came about because of changes in the social norm that demanded patients be treated with autonomy and completely eschewed strong paternalism, reserving weak paternalism for cases of minor or otherwise incompetent patients. And giving a pure placebo – lying to your patient – is about as paternalistic as you can get.

    And when (at least 4 of) the mechanisms of psychogenic placebo effects are elucidated, and demonstrated to be useful only in integration with actual medical care and not by themselves, you still go back to point #1 – we only “choose to believe” that placebo has a small, transient, and provincial effect.

    You seem to be staring at a glass that continually gets drained of water and claiming it is always half full, never mind that fact that it would be poison to drink anyways.

  27. pmoran says:

    Harriet: Placebos make people feel better. Fooling people works. Fooling wine customers with high priced labels makes them enjoy the wine more. It is seductive and paternalistic to think you are smart enough to know when fooling people is really in their best interests. Most of us don’t think we have the right to make those decisions.

    Then don’t. No one is asking that of you. I am mainly urging that we get the science of placebo sorted out.

    If a placebo suggestion can reduce post-operative opiate requirements by 33% within otherwise routine clinical care there is plenty of justification for revisiting that field.

    Pollo A, Amanzio M, Arslanian A, Casadio C, Maggi G,
    Benedetti F. Response expectancies in placebo analgesia and their
    clinical relevance. Pain 2001; 93: 77–84.

    I do happen to think that if some of the explanation for the CAM phenomenon lies in the placebo responsiveness of many conditions then that must slant how we react to it, and how we respond to other socio-medical matters. We have to allow that there is still substantial unmet medical need and that there are shortcomings to present-day science-based care, despite its brilliance in many arenas.

    So we should be careful where we use unqualified “it doesn’t work” statements. We could perhaps be LESS paternalistic and authoritarian in some areas without there being an unfavourable risk/benefit impact on the public.

  28. Harriet Hall says:

    @pmoran,
    “We have to allow that there is still substantial unmet medical need and that there are shortcomings to present-day science-based care”

    And we do allow that. But what we don’t have to allow is that CAM placebos are the solution or that they have any place in medical practice. You keep suggesting “maybe” but without any evidence.

    I agree that we should be careful about saying “it doesn’t work.” We could say “acupuncture sometimes works to make patients feel better but the effect has nothing to do with the needles or acupoints.” We could say that homeopathy works, but that its results have nothing to do with the homeopathic remedies themselves.

    “I am mainly urging that we get the science of placebo sorted out.”
    Yes, of course! That’s what Benedetti is doing, and that’s why I thought it was important to write about his work. It seems you are urging something more than that, that we should be “soft” on CAM and placebos because it is kind to give patients relief.

  29. pmoran says:

    It wasn’t that these ethical principles “miraculously” appeared – they came about because of changes in the social norm that demanded patients be treated with autonomy and completely eschewed strong paternalism, reserving weak paternalism for cases of minor or otherwise incompetent patients. And giving a pure placebo – lying to your patient – is about as paternalistic as you can get.

    You say “changes in social norms”. I suggest that it was equally or more so due to the upsurge in CAM. Why is that not on your list?

    But you do seem to agree that doctors had to change because of outside pressures, not through any inclination within the profession to give up a perceived entitlement to hegemony over medicine in general — one that continues today along with different styles of paternalism and authoritarianism.

    We cannot get away from that completely because we DO have superior knowledge. The question is whether we are exerting what influence we have in entirely good and effective ways.

    One area where I have repeatedly suggested that we need to be careful is where we lack entirely effective and safe treatments — there is still a lot of that and herein CAM mainly thrives, partly because of placebo and other quirks of the human species.

    The ethical concerns are sound, but when the ethical card is overplayed by characterizing ANY use placebo medicine use as “lying to the patient” that only reinforces my cynicism regarding the role of moral scruples in some present stances. You have been given examples of how placebo medicines could be employed without lying.

  30. nybgrus says:

    I suggest that it was equally or more so due to the upsurge in CAM. Why is that not on your list?

    Because there was no upsurgence in CAM. In fact, since the Flexner report there has been a massive decrease in CAM. As the authors here have taken pains to point out, and as I learned in my degree on the subject (I’ll mention again that I have an entire 4 year degree on this topic), it was a re-branding and public relations change. Not a material change in the existence of CAM. They just managed to use PC times to get people to stop calling them quacks. I suggest you read Orac’s “Evolution of CAM” to edify yourself on the topic.

    We cannot get away from that completely because we DO have superior knowledge. The question is whether we are exerting what influence we have in entirely good and effective ways.

    Refreshing to hear you say something sensible for a change. However, part of that is understanding our role inside the greater social context. Yes, we changed what we considered ethical (strong paternalism) because society would no longer tolerate that from us. But your argument seems to be that by not allowing placebo treatments we are being just as strongly paternalistic. That is nonsense. We also have an ethical duty to society to provide them safe and efficacious treatments – not to allow whatever they damn well please whenever they damn well want it. We cannot force treatment on a patient or treat them without consent. But we also cannot provide treatments with no efficacy. That takes out the vast majority of placebo, and, as is being shown time and again pretty much any placebo only treatment (such as acupuncture).

    But we also have a duty to our doctor-patient relationship – one that is predicated on complete honesty. Without that, we also have the strong paternalism that is unacceptable. Administering placebo is lying to your patient, even if it ultimately provides some sort of relief – objective or otherwise.

    Oh, and did I mention, we as a profession and as individuals are also part of society. Don’t treat this like we are some sort of physician aliens standing outside the space-time continuum.

    As Dr. Hall has pointed out, the error of strong paternalism – the reason why it is unacceptable – is because despite the fact that we do have superior knowledge, it is not superior enough to allow us to determine when it is acceptable to lie to our patients.

    It seems to me that a soon-to-be 3rd year medical student shouldn’t have to be telling you these basics.

    One area where I have repeatedly suggested that we need to be careful is where we lack entirely effective and safe treatments

    Indeed. And we must not be careful to just prescribe anything we want, nor experiment on our patients at our whim simply because we don’t have an evidence based answer. You seem to focus on the small and transient benefits without ever accepting the gravity of the negatives that much be taken into the calculus. For you placebo in the form of acupuncture (and others perhaps, but that seems to be your hobby horse) is all positive with essentially no negative (save the admittedly unlikely and usually minor ones of needles penetrating the skin). Intentionally or not, you are putting on blinders and trying to find justification to help your patients, in any way possible, regardless of the overarching ramifications. Which is admirable and certainly something every phsyician here (and myself) can commiserate with. But you end up doing contortions and backflips to justify those bits that keep crossing your unblinkered vision.

    but when the ethical card is overplayed by characterizing ANY use placebo medicine use as “lying to the patient” that only reinforces my cynicism regarding the role of moral scruples in some present stances.

    Ethics cannot be “overplayed.” It is vital and important. Your cynicism nothwithstanding, your argument is invalid because it seemlessly blends from individual patient to profession as a whole. This has been pointed out to you numerous times before.

    For an individual patient who is suffering and I cannot help, I might find myself willing to offer acupuncture as an alternative – provided I can recommend one I can trust to use proper aseptic technique and that I can phrase it very, very carefully. But I would do so incredibly grudgingly and only in the the rare exception… and I would know I am owning an ethical violation to help alleviate some poor soul’s suffering.

    Dr. Hall has said almost the same thing. And both of us have said we would not “slap the acupuncture needle out of grannies hand.”

    The problem is you take that and scale it up to a population and profession level without consideration for the fact that these are fundamentally different questions. You advocate for being soft on CAM so as to preserve your ability to make such ethically dubious recommendations. That is something I cannot abide.

    You have been given examples of how placebo medicines could be employed without lying

    Yes. And I have given you examples of how I have employed them in my own care of patients – alongside actual medical care. There is no way to employ a placebo only treatment without lying to a patient. But you will undoubtedly continue to try and twist evidence to the most favourable light and content yourself with a lesser degree of lying in order for the two to meet in a manner acceptable for your blessing. That may be fine for you to sleep easy at night and in a vacuum I’m sure may prove overall slightly beneficial to your patients. But it is not acceptable as a whole and it is not the way to progress medical science.

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