Jan 02 2012
On the “individualization” of treatments in “alternative medicine,” revisited
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32 Responses to “On the “individualization” of treatments in “alternative medicine,” revisited”
It would be interesting to study the extent to which the “individualized” claim for alternative medicine is even true. It’s an advertising claim really. First you’d have to define “individualized” in some coherent way, then study what exactly these alternative practitioners are actually doing with their patients that differs – if it does – from what other physicians are ordinarily doing. Surely there are some measureable variables – do the alternative practitioners spend more time with clients? That is study-able, but it doesn’t necessarily mean the treatment is more “individualized.” As to what remedies are actually prescribed for given conditions, that too is certainly study-able.
I would strongly suspect that the claim is bogus. Despite the stories about how every patient with an ordinary flu is different, my guess is, you’d find the alt-practitioner prescribing pretty much the same thing to everyone, after all. I mean, patients don’t know what was prescribed to the person before them and the person after them, right? They’re TOLD their treatment is individualized, but how would they know the difference? I bet the claim to spend more time per patient would also go up in a puff of smoke once you measured it.
Someone should do this research. Of course, it wouldn’t convince fans of alt med of anything … but it might get closer to the question of what exactly alt med fans *want* that they actually *get* from their favorite purveyors of woo. I think it’s something other than “individualized” treatment – a sense of themselves as special, perhaps?
Dr. Gorski, I think this is one of your best posts. This is an absolutely fantastic read.
In 2010, Brien et al found that in the case of homeopathy, patients actually benefited from the lengthy and involved consultation process, where as patients who received homeopathy with no lengthy consultation process had no improvement over placebo.
So, as you said, the placebo effect in alt-med is largely due to having someone just spend a lot of time with the patient. Of course, this may only lead to subjective and not objective improvements.
(Brien, S.; Lachance, L.; Prescott, P.; McDermott, C.; Lewith, G. (2010). “Homeopathy has clinical benefits in rheumatoid arthritis patients that are attributable to the consultation process but not the homeopathic remedy: A randomized controlled clinical trial”. Rheumatology 50 (6): 1070–1082.)
Ernst wrote, regarding this finding:
“Proponents of homeopathy insist that this is a contradiction. Moreover, they claim that the clinical trial is an inadequate research tool for testing their treatment and that therefore the true picture is provided by the observational data. But the much more logical conclusion is what Brien et al. have now demonstrated experimentally: patients benefit from a long and empathic encounter with a homeopath but not from the remedy. Homeopaths might argue that these results prove that homeopathy, even though it is not efficacious, is nevertheless effective. . But I fear that this would be misleading: the effective element is not specifically homeopathy but the therapeutic relationship in general.
The recognition of the therapeutic value of an empathetic consultation is by no means a new insight, yet it is knowledge that is in danger of being forgotten. Modern mainstream medicine frequently seems to neglect the importance of medical core values such as empathy, sympathy, time, understanding and holism. This creates a situation where alternative practitioners tend to provide the non-specific and mainstream doctors the specific effects. Clearly, this is wrong and may well be one reason why patients consult alternative medicine practitioners. I would argue that any good medicine must offer both, and we should be skeptical of those clinicians who opt for providing only one or the other.”
(Ernst, E. (2010). “Homeopathy, non-specific effects and good medicine”. Rheumatology 50 (6): 1007–1008.)
Taking all this together, it’s easy to imagine that a patient who is hoodwinked into believing they are receiving a mystical personalized treatment will have placebo benefit. Of course, we all know that a medical doctor can not pay the bills if they see 8 patients a day. But as doctors, we can aim to provide the best possible doctor-patient interaction.
All that said, one of the most important challenges facing medicine right now is to get a better understanding of heterogeneity of treatment effects (HTE) and to develop experimental and analytic methods that do a better job of sorting out who is most likely to benefit from what treatment. Statistically significant differences in outcomes between two study arms typically — not sometimes or as an interesting anomaly, but typically — conceal large differences in effect within each arm. Some people in the arm that is found superior are often, in fact, harmed; while some in the less efficacious arm in fact benefit. This is not unusual at all, it’s the truth about RCTs that is often overlooked.
Quoting from the post, “Certainly, organisms such as humans can and do show considerable variability in their biology and response to treatment, but rarely so much that what “cures” one person will have no effect on the next. ” I have to differ — this is not rare at all. Much of medical practice — including oncology, as Dr. G ought well to know — is essentially empirical. Physicians may be uncertain of the diagnosis, so they try something and end up ruling out because the symptoms are unresponsive. Some people respond to anti-depressants, but most do not. (True fact, though little mentioned.) “Cancer” of course is not one disease but innumerable different genetic anomalies and the responsiveness of a cancer to a treatment is highly variable. I could go on and on but this is not the place for it.
One of the most important missions of the new Patient Centered Outcomes Research Institute is to work on sorting all this out – discovering how to provide the necessary evidence and ways of communicating it that will enable us to do a better job of determining what is right for the individual patient. The woomeisters are full of crap, but this is an actual, true, real, genuine challenge for science-based medicine.
“the placebo effect in alt-med is largely due to having someone just spend a lot of time with the patient”
So there’s one theory: the difference is “time.” But is this true? Is there any evidence alternative practitioners spend more time with patients? If there is evidence that additional time spent with patients increases or potentiates the placebo effect, how much time are we talking about?
“the much more logical conclusion is what Brien et al. have now demonstrated experimentally: patients benefit from a long and empathic encounter with a homeopath but not from the remedy.”
So there’s a second suggestion: “empathy” makes the difference. Again, is there evidence that alternative practitioners are actually more empathetic? Has someone studied this? Using what sample size, and what measures of empathy?
One possibility is that time and empathy are really the same thing, that is, the patient perceives he/she has been treated empathetically just because the doctor spent a long time on the consultation.
I have no credentials to critique those studies but seriously, I doubt the “time and empathy” hypothesis is even true. I do not think we are talking about time and empathy. I think we are talking about advertising.
[...]
Well, yes and no. In cancer, especially, what we are looking at are degrees of response. It’s usually not cure versus no cure. I have, of course, written extensively about genetic variability in cancer right on this very blog, as well as the issues of lead time bias, cancer evolution, and various things that can mean the difference between a treatment being efficacious or not. In any case, the passage I quoted was originally written five years ago and then updated for SBM a year and a half ago; so perhaps these days I’d change the word “rare” to “relatively uncommon.” Be that as it may, “personalized medicine” and “individualization” of treatments have turned out to be devilishly difficult and complicated. Although, as I said in some of my posts about Burzynski’s co-opting of the concept, I actually do believe that one day we’ll have a decent form of “personalized medicine” based on genomics and biology, I also believe that “personalized medicine” right now all too often overhyped in the absence of much evidence that it does much better than old-fashioned EBM. In any case, human biology is very complicated, and such predictors are probably decades off. Perhaps that’s why the co-opting of “personalized medicine” by woo-meisters bothers me so much. The last thing I want is for a promising area that in the long term has great potential to improve human health to become tainted with the reputation of quackery.
This analogy actually shows exactly why they are wrong and why medical trials work.
Except for insanely expensive tailoring, nobody measures a customer’s foot and then creates a custom shoe just for them. The seller measures the customer’s foot, and then gets one of only a handful of different sizes available. Far from being so personalized as to evade scientific study, each given shoe size is actually sold to millions of different people.
And what sort of scientific study might we want to do, if the concept of a shoe had just been invented? Well, we might want to do Phase I trials to find out if shoes are safe to wear, and how big of a shoe can be worn safely. Is the wearer going to experience discomfort or injury if the shoes are too big? How big can the shoe get before the wearer risks twisted ankles and tripping? Does the shoe remain on the foot all day without falling off?
Then we might want to do Phase II trials to find out how much benefit the wearer gains from wearing a shoe within the safe range of shoe size for their foot. If shoes in any size are harmless, but still beneficial, we can sell a nice big shoe which fits everyone. If having oversized shoes produces a risk which outweighs the benefit of going barefoot (and in fact, this is the case in real life), then we would have to sell shoes in multiple sizes so that a person can get a shoe within the safe size range for their foot, just as drugs with potential side effects and overdosing are available in different amounts. The foot’s tolerance for slightly imperfect shoe size will determine how many different shoe doses we have to manufacture for a Phase III trial and mass marketing.
And then we can argue about whether or not commercial shoe production has produced enough size variety for everyone, and weigh the ups and downs of possibly having the government mandate more varied shoe sizes.
You never disappoint.
Cited this on my REC blog just now.
Dammit, Carl. You did a much better job of deconstructing that analogy than I did. I might have to steal that.
Dave Gorski wrote: “The last thing I want is for a promising area that in the long term has great potential to improve human health to become tainted with the reputation of quackery.”
You said it. To quote an old advert for tyres, “This is where the rubber meets the road”. A negative perception is almost impossible to get rid of once it has taken hold of the public mind.
Imho, that’s why many people are turning to woo … because they have been fed from childhood on anti-EBM propaganda. And like people that are used to junk food, they really don’t want to change their diet.
Besides, woo tastes good so it must be good, not so? Taste = “you are unique”, “you are a rebel at heart”, “you are not taken in by Big Pharm like the rest of these sheep” and “your friends and relations will be ever so impressed”. These taste good, sure … so naturally they must be healthy and nourishing … sure?
“they make a great show of pointing out that ‘statistically significant’ doesn’t necessarily mean ‘significant.’”
But the problem is that they try to use this correct conept to essentially argue that “statistically insignificant” doesn’t necessarily mean “insignificant.” There they are on much shakier ground!
Especially in homeopathy it’s very simple. In ordinary medicine it is quite tricky tot devise a credible placebo, but a ‘placebo homeopathic remedy’ that has to be compared to some highly diluted ‘real’ homeopathic remedy is the easiest thing to make. And in fact quite a few such RCTs have been performed, mostly with results that were disastrous for homeopathy.
Medical research with sick people is usually quite expensive, but here homeopathy has another advantage. Homeopathic individualized remedies are based upon the premise of the existence of so-called drug pictures. There are roughly 1000 homeopathic remedies (not counting different degrees of high dilution), each with roughly 1000 ‘symptoms’, namely subjective phenomena experienced by people who have taken highly diluted substances. (Forget about coffee making you sleepless, so diluted coffee for sleeplessness.)These symptoms have been obtained by so-called provings. None of those remedy-symptom combinations that fill the homeopathic Materia Medica have been properly reproved.
Individual homeopaths will challenge their opponents by asking them to take (for example) a few doses of Sulphur 200C and experience unbearable itch. But whenever they are asked to help organise a decent test with proper randomizing and blinding and a fair number of participants, a deafening silence ensues, or the homeopaths will say that they don’t have to prove themselves or that they are too busy with treating patients or that they suspect statistical trickery. This is strange, because a reproducible reproving in any form would bring the homeopaths fame and earn them many ‘skeptical’ rewards, i.e. over a million dollars for starters.
Summarizing: individualized homopathy can be tested quite easily and that has been done. The roughly one million remedy-symptom combinations that form the basis of the individualized homeopathic treatment can easily be tested, but homeopaths all over the world shun doing that.
In my mind, one of the more effective demonstrations that CAM isn’t really “individualized” is the existence of OTC homeopathic remedies. Supposedly the remedy (or remedies) needs to be carefully matched to the symptoms, but then they tell everyone with a cold to use Zicam.
BUT – Remember – Zicam actually has something detectable in it!
I don’t know about the USA, but the enduring popularity of homeopathy is the result of the efforts of Big Homeo, who not only market remedies like Natrum Muriaticum 30C, but also various nostrums with suggestive names containing mixtures of highly diluted remedies (something the founder of homeopathy would have disapprobed of) and also herbal preparations like Arnica and Echinacea that contain large amounts of plant extracts (if an extract is prepared in the manner of a homeopathic mother tincture, the stuff technically counts as homeopathy). So homeopathy became in the popular perception synonymous with ‘herbal medicine’, mainly through the efforts of Big Homeo. Big Homeo not only spends a lot on advertising, but also puts a lot of effort in lobbying in parliaments organising patients to write letters or sign petitions, and so on.
Ordinarily, a homeopathic healer can do with a very small stock of remedies, because typically treatment would start with having the patient take one single 5 mg globule, and then wait a month to study the reactions. That is no big business for companies that want to sell in bulk.
So Big Homeo makes homeopathy popular, and the physicians that do the ‘real’ homeopathy give it status. Itr’s like astrology which is consumed in large amnounts in the form of newspaper horoscopes. These newspaper horoscopes have revived astrology from a moribund kind of esoteric advice to a thriving business, relying on the status of ‘real’ astrologers who take a lot of time to interpret highly individualized horoscopes in 1 one 1 consultations.
People like this are idiots…even this simple statement:
“Using this information, the government proposes to give everyone a pair of average-sized shoes. Clearly, this would be unwise-the shoes would be either too big or too small for most people.”
Even if we assume that the analogy is accurate (which of course it isn’t medicine does not have to be as fitted as a shoe) it leaves out a few rather obvious bits of math. A remedy isn’t looking at treating everyone, just everyone who is sick. So the scale is way off. On top of that the people have clearly never heard of measuring variance. If the standard deviation of the mean was 0.0001 then the mean shoe size would likely fit the vast majority of people (assuming the distribution is relatively normal).
Sorry for the double post but I also never understand how these people get around the obvious chicken-egg problem individualized medicine. How do you individualize treatment for someone you’ve never met before? Right! you would rely on some generalized knowledge of the mechanisms of the body that has some variance across it’s functions (i.e. some people respond to drug A but others to drug B) and then use other information to narrow down the possibilities.
The problem here is that this assumes that you have an accurate model of the mechanisms of the body. Yet, when we examine various kinds of CAM that’s exactly what they don’t have. We don’t have Qi running through our bodies, we don’t have subluxations, etc…
Hmm … it looks like Hickey and Roberts are missing a footnote:
*All recommendations are category 3 unless otherwise noted.
“How do you individualize treatment for someone you’ve never met before?”
__
Read “Medicine in Denial,” Lawrence and Lincoln Weed, ISBN 1456417061
e.g.,
“…Closing the gap between medical practice and patient needs would trans- form how medicine is personally experienced by practitioners and patients alike. Practitioners could find their work to be less exhausting and more rewarding, emotionally and intellectually, than what they now undergo. The physician’s role could disaggregate into multiple roles, all freed from the impossible burdens of performance that physicians are now expected to bear. The expertise of nurses and other non-physician practitioners could deepen, and their roles could be elevated. All practitioners could follow time-honored standards of care that in the past have been honored more in the breach than the observance. All practitioners and patients could jointly use electronic information tools for matching data with medical knowledge, radically expanding their capacity to cope with complexity. All could use structured medical records, whose structure would itself bring order and transparency to the complex processes of care. Inputs by practitioners could thus be defined and subjected to constant feedback and improvement. A truly evidence-based medicine could develop, where evidence would be used to individualize care rather than standardize it. And a system of checks and balances could develop, where patients and practitioners would act on incentives for quality and economy far more effectively than before.” [pp 4-5]
Not that I buy the whole thesis uncritically. It is, though, a detailed, documented read.
I found it interesting that the following article showed up at MedlinePlus on 2 Jan 12:
http://www.nlm.nih.gov/medlineplus/news/fullstory_120341.html
I like the following quote:
“We found that there are some viable treatment options for neck pain,” said Gert Bronfort, vice president of research at the Wolfe-Harris Center for Clinical Studies at Northwestern Health Sciences University in Bloomington, Minn.
“What we don’t really know yet is how to individualize these treatments for each particular patient. All are probably still viable treatment options, but what we don’t know is what each particular patient will need,” Bronfort said, adding that it’s possible a combination of treatments might be helpful, too.
Of course the Northwestern Health Sciences University appears to be a chiropractor/acupuncture/massage and “Teaches and promotes natural approaches to health and health care.”
Conspicuous Carl “Well, we might want to do Phase I trials to find out if shoes are safe to wear, and how big of a shoe can be worn safely. Is the wearer going to experience discomfort or injury if the shoes are too big? How big can the shoe get before the wearer risks twisted ankles and tripping? Does the shoe remain on the foot all day without falling off?”
Apparently, everyone else here can easily read this analogy and not once envision a hoard of people flopping around in huge shoes.
Damn EBM and this clown shoe epidemic!
@JohnW,
I found that study interesting because although patients were “more satisfied” with manipulation, its early results were no better than home exercise, and the late results favored home exercise: at one year, 37% of the exercise group and only 27% of the manipulation group had experienced 100% pain relief. The real lessons are that neck pain is likely to go away eventually on its own, and that hands-on, TLC treatment and attention are preferred by patients but are less effective in the long term. And the authors point out that neck manipulation can be dangerous.
@BobbyG. I actually don’t think I understand what you are saying. I’m saying that in order to “individualize” medicine. You need something to individualize – the only thing you can individualize is something that actually has variance of effect. For example something that never helps anyone can not be individualized any more than something that helps everyone all the time.
How do you validate if some treatment has variance of effect?…by doing large trials. The very thing CAM people say aren’t necessary.
@Werdna -
Read the book. I’m not talking about SCAM.
And now, imagine them playing tennis.
Steal away, but I think I worded the third sentence in the larger paragraph backwards. I meant to express concern that the risk of oversized shoes might outweight the RISK of going barefoot, not the benefit of going barefoot.
@BobbyG – or instead you can give me the argument assuming you understand it. If you don’t – that’s cool but perhaps stop promoting it otherwise lay it on me.
I saw the snippet or two on your site. It doesn’t say much even the quote you gave above barely makes a useful statement.
@ ConspicuousCarl, hehe, even better.
@Werdna
It’s a long book. I’ve only begun citing parts of it.
“How do you individualize treatment for someone you’ve never met before?”
I never claimed to to be simple. Nor is it instant. You have to start somewhere, though. Moreover, I don’t buy everything in the book uncritically, though I find their argument for truly “individualized” care pretty intriguing.
“First, from the outset of care, relevant patient data must be chosen, and its implications determined, based on the best available medical knowledge, independent of the limited personal knowledge of the practitioners involved. Patient data must be systematically linked to medical knowledge in a combinatorial manner, before the exercise of clinical judgment, using information tools to elicit all possibilities relevant to the problem situation, while defining and documenting the information taken into account. Practitioners’ clinical judgments may add to, but must not subtract from, high standards of accuracy, completeness and objectivity for that information.” [pg x]
“Without the necessary standards and tools, the matching process is fatally compromised. Physicians resort to a shortcut process of highly educated guesswork. They begin with guesses about diagnostic possibilities that might account for the chest pain. Sometimes very sophisticated, these initial guesses lead to further guesswork about what to check during the initial history, physical examination and laboratory tests for investigating whatever diagnostic possibilities come to mind. And then physicians make more guesses about what the data mean, which in turn shapes their judgments about what further data to collect. Varying from one physician to another, these highly educated guesses are not explicit—physicians do not carefully record their thinking or the information they take into account. Inputs to decision making are thus undefined.
We use the term “guesses” because these key initial judgments are made on the fly, during the patient encounter, based on whatever enters the physician’s mind at the time. That mind may be highly informed and intelligent, but inevitably its judgments reflect limited personal knowledge and experience, and limited time for thought. Euphemistically termed “clinical judgment,” physician thought processes cause a fatal voltage drop in transmitting complex knowledge and applying it to patient data. The outcome is that the entire health care enter- prise lacks a secure foundation.
Equally insecure are the complex processes built on that foundation: de- cision making, execution, feedback and corrective action over time. Responsibility for all these processes falls on the mind of the physician. Here again the mind lacks external tools and accounting standards for managing clinical information.” [pp 2-3]
“In maintaining health, in chronic disease, and in the events that lead to acute illness, the patients themselves know and control more of the relevant variables than anyone else. Patients live with the variables all the time. When the values of those variables change (when the situation changes), they can be the first to know.
Physicians often know only a few of the variables and usually have direct control over none. Physicians and other medical personnel see a fragment of the total during a fragment of the time.” [pg 253]
” Right! you would rely on some generalized knowledge of the mechanisms of the body that has some variance across it’s [sic] functions (i.e. some people respond to drug A but others to drug B) and then use other information to narrow down the possibilities.”
Well, yeah, precisely.
Sorry if I wasn’t clear.
“give me the argument assuming you understand it”
I’ll pass on that.
Hickey and Roberts are wrong yet again.
“Population statistics do not capture the information needed to provide a well-fitting pair of shoes, let alone to treat a complex and particular patient. As the ancient philosopher Epicurus explained, you need to consider all the data.”
Of course population statistics capture the information needed to provide a well-fitting pair of shoes. How to they think shoe manufacturers know what size increments to make shoes in, and how much of each?
@Jan Willem Nienhuys: I have suspected that the non-homeopathic homeopathic remedies are prepared as they are, with homeopathic mother tincture and then potentized to 1X or some other low dilution, to avoid the necessity for the Quack Miranda Warning and to allow the sellers to make positive health claims for their products. A manufacturer of herbal remedies cannot make any claims for efficacy or suitability if the FDA doesn’t permit it for those herbs, but call something “homeopathic” and, thanks to the loopholes written into US law specifically to accommodate homeopathy, they can claim whatever the HPUS lists for the materials they include. Unless I misunderstand the law, all that’s required is that the remedy be prepared according to homeopathic techniques.
Lytrigian wrote (http://www.sciencebasedmedicine.org/index.php/individualization-of-alt-med-treatments/#comment-80864 )
In Europe it’s a bit more complicated. EU directives regarding homeopathy (hm) distinguish two types of hm products: the highly diluted ones and the low dilutions. The high dilutions don’t need efficacy proofs, only proof of safety and guarantees that the manufacturer prepares as he claims. No indications were allowed for high dilution hm products. For the low dilutions (with indication) proofs of efficacy are required. In itself this is not a bad idea: if someone wants to buy Mercurius Solubilis 30C, then let him (or her), as long as it does no harm and as long as the packaging of the medicine only says ‘Mercurius Solubilis 30C’ without any claims about what it does.
Admittedly this is a bit silly, comparable to allowing the sale of holy water, provided that a state committee has checked that it is sterile and that the priest who did the blessing is properly ordained.
Now EU directives are not laws. They are instructions to the member states to make their own laws in accordance with the directives.
But these directives had loopholes and backdoors. In the Netherlands the ‘traditional specialties’ loophole was used to permit hm products with low dilutions (one product is for example an Arnica ointment for bruises containing 30% mother tincture). The loophole was explicitly used as a favor to the hm Big Pharma lobby. So the Dutch committee for judging medicines also approved low dilution products with indication, provided the producers printed a disclaimer on the label (saying that there was no scientific proof for the efficacy). Initially the hm producers complied but then they complained in court, saying that the law didn’t say anything about this disclaimer for low dilution products. The court accepted this. Next the state abolished the whole special treatment on basis of the loophole and gave the hm producers until January 2008 to hand in proper proofs of efficacy for all their low dilution products. Of course none of them did, and then one product was explicitly forbidden, as a test case. The producer immediately objected and started juridical proceedings which they can drag on all the way to the European courts. (These hm producers spend exactly nil on decent efficacy research, but they shell out millions for legal procedures, also against critics.) Meanwhile all their products remain in the shops, including the famous Oscilloccinum that got a permit to mention the indication ‘flu’, probably because the committee was hoodwinked by the fraudulent research by Ferely et al. and later by Papp et al.
This is roughly the Dutch situation. In other EU countries the situation is different: everywhere ‘highly individualized’ loopholes and backdoors are used. In addition there are new EU-directives regarding hm products. If there is traditional hm literature mentioning diseases and symptoms for some hm product, then it is allowed to sell them with these indications. See directive 2004/27/EC , which requires that every EU member state establishes a committee consisting of scientists and quacks to determine what exactly the traditional hm literature says.
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