Summertime and the living is busy.  Finally we have sun in the Northwest.  While the rest of the country has been melting in heat, this year we have rarely cracked 85.  Global heating has avoided Oregon this year, and I will need some green tomato recipes.  Good weather, work is busy, and it is the last two weeks with my eldest before he is off to Syracuse, so there is little time for writing, so a brief entry this week.

I always wince at the way anything can be called ‘therapy.’ We have music therapy and garden therapy and pet therapy and art therapy.  I do not deny that it is beneficial for people to participate in those activities while in the hospital, although I am never happy to see disease vectors, er, animals in a hospital.   Dinner should be food therapy, reading should be book therapy, and using the internet should be computer therapy.  I guess it is like calling something ‘medical’ grade, and you can bill more for it.

Some ‘therapies’ are a wee bit more odd.  Indonesians are using railroad therapy.  People lie down on electric railroad tracks because “the electricity current from the track could cure various diseases.”  To date no one has been either electrocuted or squashed, but I suppose it is only a matter of time.

Why train tracks?  Why not a tongue in a light socket or other source of electricity?  Evidently rumor has it that “an ethnic Chinese man who was partially paralyzed by a stroke went to the tracks to kill himself, but instead found himself cured.”  Sounds good to me.  It seems as likely as Palmer cracking a neck leading to a cure in deafness as the basis for a therapeutic intervention.

And so others are using train therapy for their hypertension, diabetes, strokes and other medical problems.  Train therapy is evidently a panacea for a variety of diseases and used by those with no other medical options.  Like all alternative therapies, it is effective against numerous diseases, regardless of the underlying pathophysiology. If only antibiotics could cure hypertension, diabetes and stroke in addition to bacteria.

Does train therapy work?  The patients say it does, despite those know it all skeptical MDs who point to a lack of evidence.  And who would gainsay a patient’s response to the therapy?  If a patient says they are better, are they not better?

Medical experts say there is no evidence lying on the rails does any good.
But Mulyati insists it provides more relief for her symptoms — high-blood pressure, sleeplessness and high cholesterol — than any doctor has since she was first diagnosed with diabetes 13 years ago.

I was worried they would forget to tell both sides of the story.  And just who is expert on the medical effects of lying on electric train lines?  They go on to note that

Pseudo-medical treatments are wildly popular in many parts of Asia — where rumors about those miraculously cured after touching a magic stone or eating dung from sacred cows can attract hundreds, sometimes thousands.

It would be easy to be snotty and superior about the Indonesians and their use of train therapy, but really, is it any different than the West?  They eat dung from sacred cows, we have the bullshit from the NCCAM.  We have reiki and homeopathy and Tong Ren healing, and all the other therapies that are subject of this blog,  all equally nonsensical.  I see little difference between the use of train healing and much of the published literature in the SCAM world.  A series of uncontrolled interventions with soft endpoints.

Indonesians have the same rationale for the use of train therapy: anecdotes. Every homeopathy apologist mentions  that the millions who have used homeopathy with good effect can’t be wrong, and neither can the hundreds who are using train therapy.  I suppose we could say the Indonesians are doing a pragmatic, real world trial.  Who needs the old randomized, placebo controlled nonsense?  Lie on an electric train track and you feel better. ’nuff said.

Are the patients who believe they are getting better experiencing a placebo effect?  Is this an example where patient centered outcomes are more important that doctor centered outcomes?  Maybe we should use train therapy for the treatment of asthma.  Conductors and engineers, like doctors, “often dress up in special uniforms that convey power and authority… (and) They have very expensive machines”  Probably less expensive than sham acupuncture and sham albuterol.

Train therapy fits the criteria noted in the recent NEJM editorial;  it should be sufficient to “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.”  The train track users say they are improved, it is free, and as long as they get up in time, should have no negative effects.  I would avoid TGV tracks, just to be safe.  I expect train therapy to be come incorporated in Integrative Medicine programs everywhere, or at those near light rail.

There was a time when I was inclined to think that the people who participated in SCAMs were either stupid or ignorant.  I have long ago abandoned that idea.  Some people, as evidenced by occasional comments in this blog, are apparently deranged, but not most.  I have realized that while most SCAMs are stupid, the people who use them are not.  It seems to be a universal human characteristic to participate in nonsense of one kind or another, but the nonsense varies by culture and opportunity. ‘We’ detox our colons and avoid vaccines, ‘they’ eat dung and lie on train tracks.  All are human. Or are they?

Most biologic characteristics have variability. Height, strength, intelligence all vary about the infamous bell shaped curve.  I have also wondered about more intangible characteristics: the ability to think rationally or empathy or a sense of humor.  Like jumping or math, some people seem to be better at these tasks than others.  It does not, I hasten to add, make them better people, except for the task at hand.  I wonder if the uber-rational, the skeptics, are mutants, given what appears to be the relative rarity of rational/scientific thought.  And to judge from the vitriolic response towards the scientific/rationally inclined, the rational must be mutants as they are feared and hated by those they were sworn to protect.

I don’t know.  Idle speculation caused by vitamin D deficiency.  I am going to lie in the sun, not on the Max line. I know this will make me feel better, although I doubt it will cure any illness.

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I have as much of a sense of nostalgia as anyone.  I love history.  I think that there is lots to be said about the “good old days,” whenever the heck they were.  I do not, however, think that the “good old days” generally include medicine.

The fact is that it’s only been about 100 or so years since medical practitioners really got their acts together and started to be able to figure out if they were actually doing anything good.  Prior to that, medicine was a world of humo(u)rs and miasms, treated by bleeding, burning, and purging, plants and animal matter of all sorts (the 6th century Chinese apparently liked otter feces) and all sorts of other awfulness.  In light of some of the things that were done, it’s kind of amazing that anyone survived their treatments.  Mostly, people (and horses) survived in spite of the crazy things that were done to them.

Nevertheless, in those wild and wooly days of yesteryear, enterprising medical entrepreneurs turned out an endless stream of products, with some pretty fantastic claims.  They designed some absolutely artistic advertising cards to go along with those claims, too.  These trade cards surged onto the scene in the 1870′s, coinciding with the advent of color printing.

Look as hard as you’d like – you won’t find any of those products today.  But the claims?  Well, the claims are still around, and they’re pretty much the same as they were 100+ years ago!  Seriously, today, you will find people making the same ridiculous claims for their particular nostrums as they did over a century ago.  Here are some examples -

1.  Are you worried about your horse’s blood being impure?  According to an archaic and somewhat ridiculous line of thinking, “impurities” of the blood are one serious problem.  Of course, no one ever says what those impurities might be, but, no worries, you can get the blood purified anyway!  And, according to a modern text on veterinary herbal medicine, the herbs turmeric and sweet Basil are “Blood purifiers”  – Wynn, S and Fougère, B.  Veterinary Herbal Medicine, 2007, p. 69.

You could have purchased this “blood purifier” over 100 years ago!

2.  Worried about pain?  Why not try some “essential oils?”  According to the website, “The Holistic Horse,” essential oils of peppermint and eucalyptus are a must!  It’s hard to say what the oils are essential for – certainly not for the relief of pain!  There’s certainly nothing wrong with the pungent smells of eucalyptus or peppermint, and, of course, peppermint is a popular flavoring agent.

Of course, oils as pain relievers are nothing new.  If you wanted to buy some pain oil in 1897, you could!  Who knew that people would still be buying this stuff 127 years later?

3.  Concerned that your horse’s kidneys need rejuvenating?  Don’t worry if you didn’t know that they weren’t juvenile enough – inventing problems is one of the great ways to come up with a cure.  If you’re concerned, just go to the website for WolfCreek Ranch and pick up some “Kidney Rejuvenator.” In case other members of your menagerie have problems, it also works on elephants and giraffes.

Or, if you were around 127 years ago, you could have picked up some Hunt’s Remedy.  Not only was it “Never Known to Fail,” you could take care of a lot of other stuff, a sort of one stop medical shop.  I’ve never seen a medicine that never failed – I wonder why you can’t buy any today?  After all, it was good for your cattle, hogs, and poultry, too!

4.  Worried about your horse’s condition?  Who wouldn’t be?  If so, why not try “Pink Powder?” As advertised by Wessex Animal Health in the UK, “For everyday equine life, Pink Powder maintains perfect condition.”

Or, perhaps you might be persuaded by this ad, from 1905?

Look, medical conditions occur for specific reasons.  Horses don’t have unnamed “toxins” circulating around in their body, their blood doesn’t need to be “purified,” their kidneys don’t need “rejuvenating,” and as long as you feed them properly, their “condition” will generally be just fine.  If you look at most any of the claims made for supplements, you’ll find that, at the bottom of it all, they’re pretty much nonsense.

Don’t expect that some untested over-the-counter product that you can buy in a bucket in the feed store is going to somehow bring health and longevity to your horse (or any other animal that you want to take care of.  The best way to do that is REALLY old-fashioned – it was known even prior to glitzy advertising and vague promises – through good feed, regular exercise, and attention to a few routine health details (such as deworming, and vaccination).

Remember, if it sounds too good to be true, it probably is!

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In 1994 Congress (pushed by Senators Harkin and Hatch) passed DSHEA (the Dietary Supplement Health and Education Act). As regular readers of SBM know, we are not generally happy about this law, which essentially deregulated the supplement industry. Under DSHEA supplements, a category which specifically was defined to include herbals, are regulated more like food than like medicinals.

Since then the flood-gates opened, and there has been open competition in the marketplace for supplement products. This has not resulted, I would argue, in better products – only in slicker and more deceptive claims. What research we have into popular herbals and supplements shows that they are generally worthless (except for targeted vitamin supplementation, which was already part of science-based medicine, and remains so).

A company can essentially put a random combination of plants and vitamins into a pill or liquid and then make whatever health claims they wish for their product, as long as they stay within the “structure-function” guidelines. This means they cannot claim to cure or treat a specific disease, but this has proven to be an insignificant limitation on marketing supplements.

It has been fascinating to watch the evolution of supplement marketing claims and strategies. One new twist caught my eye – what I am calling the “scam scam.” Some companies realize that the internet is the primary battle ground for the marketing of their product. Many companies also probably know that their claims are largely scientifically baseless – if you’re in the meeting where the claims are crafted and the marketing strategy developed, it would be hard to be delusional about their scientific validity. I suspect most companies just don’t care about the science or understand it, and you can find some justification to cherry pick for most any supplement claim you wish with just a little Googleing.

It also appears that many companies are starting to realize that “those meddling skeptics” are starting to cramp their style, at least a little bit. If you search on the name of a supplement product, you are likely to get a link for a consumer protection or skeptical site revealing the claims to be a scam, or at least scientifically dubious. Invariably when I write about a specific product in a blog post a company marketing rep will show up in the comments to claim that I was unfair and that they do have evidence for their claims. Of course, when asked for the evidence it rapidly becomes clear that they don’t have any, outside a worthless in-house study or two.

Companies cannot silence the scientific analysis of their claims. Some have tried using the libel laws, but that has generally not worked out well for them. That approach instantly raises the visibility of the criticism by orders of magnitude, and the companies or individuals generally lose in the end.

So now some companies have hit upon a different strategy – if you cannot silence the skeptics, then bury them with fake skeptics of your own. That way at least their websites won’t appear on the first page of Google searches (at least that’s the hope). One product, Shakeology, seems to be marketed entirely as “Shakeology Scam” (trek2befit (dot) com/shakeology-scam). The website starts out saying – “Do Not buy Shakeology” with “Skakeology Scam” in big letters. Of course, when you read down even a little bit you find:

Ok, I couldn’t let this question linger any longer. I’ve got to tell you right now, that it’s not a scam. Why, and how do I know? Because I’ve had first hand experience with this product.

Then you get a standard sales pitch – but it’s more believable, because the person making the pitch started out as a skeptic – right? What do these magic shakes do? The claims are typical – lose weight without food cravings, have more energy, and they throw in that they will lower your cholesterol. What are in these shakes:

- Antioxidants: Will help to boost your immune system to prevent you from getting sick. Antioxidants will also help to lower free radical damage which can lead to stroke, heart attacks, high blood pressure, and heart disease.
- Prebiotics AND Probiotics: Will help to support your immune and digestive health.
- Phytonutrients: Will help to support healthy immune function. They also have anti-inflammatory properties, and antioxidant properties.
- Vitamins and Minerals: Will help you to maintain optimal health.
- Whey Protein: Will help you to lose weight, build muscle, supports brain functions, as well as keeps your bones and skin healthy.
- Digestive Enzymes, Fiber and More…

Antioxidants are of no proven benefit, and may actually be associated with a higher death rate. Prebiotics and probiotics are of no benefit when taken routinely, and of dubious benefit (and only if taken very early and in sufficient amounts) for antibiotic-associated GI syndromes. Phytonutrients and routine vitamin supplementation – again, no proven benefit. Whey protein is protein, and you can get this a lot cheaper by drinking Yoohoo. And again, digestive enzymes are of no proven benefit for routine use. Fiber is good, but you don’t need to buy expensive shakes to get it.

The claims are typical and you can find them on thousands of websites selling all sorts of supplements. But the “scam scam” marketing is a nice twist. I especially like the glowing comments at the bottom that read like ad copy.

I have encountered this strategy before also – with some of the “superfood” products. Specifically, there has been an acai scam marketing campaign going on. If you search on “acai scam” you will find sites with headlines like, “Acai Berry Scam – the Untold Truth about Acai Berry Scams.” Once again, when you read the copy you find that an “independent reporter” investigated the alleged scam and found that that a particular acai berry product was not a scam and really worked. Some are formatted as if they are news sites, complete with stock photos of fake reporters.

So don’t be scammed by the scam scam. It’s all just another marketing ploy in the wild west of the supplement marketplace.

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A correspondent asked me to review the book What to Expect When You’re Expecting by Heidi Murkoff and Sharon Mazel. She wrote “I’m very worried about this book.”

She had just seen an NPR article about the book and was alarmed because it provided an excerpt from the book recommending that patients with morning sickness “Try Sea-Bands” and “Go CAM Crazy.” She knew from reading SBM and other science blogs that “going CAM crazy” is not a good idea. She was savvy enough to search Google Books with the title and “CAM” and found more alarming advice. 

The book is billed as the #1 bestselling pregnancy book and is now in its 4^th edition. It has been widely praised by the media and by doctors. In Amazon’s sales rankings it’s number 1 in its category and number 57 overall. It even has its own article on Wikipedia that tells us

Originally published in 1984, the book consistently tops the New York Times bestseller list in the paperback advice category, is one of USA Today’s “25 Most Influential Books” of the past 25 years and has been described as “the bible of American pregnancy.” As of 2008, over 14.5 million copies were in print. According to USA Today, 93 percent of all expectant mothers who read a pregnancy guide read What to Expect When You’re Expecting.

So it’s certainly worthwhile to look at this book to get an idea of what American women are learning about pregnancy.

It’s an impressive tome (616 pages) that does a good job of explaining everything an expectant mother might want to know as well as some things she mightn’t (critics have called it too alarmist because it covers scary complications).  It covers fetal development, diet and lifestyle recommendations for a healthy pregnancy, common symptoms, labor and delivery, the postpartum period, and much more. It is well-organized and easy to read. It has question and answer sections to cover pretty much every question a pregnant woman has ever asked, even rather silly ones (“All my pregnant friends seem to have problems with constipation. I don’t — in fact, I’ve remained very regular. Is my system working right?”) and it has separate chapters on every month of pregnancy.

Most of the book is so good I wish I could recommend it. But it has a disturbing flaw: misinformation about CAM. Here are some examples from its section on CAM:

The Place of CAM

CAM is more and more likely to find a place in your life…[Its practitioners examine and integrate] the nutritional, emotional, and spiritual influences, as well as the physical ones. CAM also emphasizes the body’s ability to heal itself, with a little help from some natural friends, including herbs, physical manipulation, the spirit, and the mind.

Acupuncture

The Chinese have known for thousands of years that acupuncture can be used to relieve a number of pregnancy symptoms… Scientific studies now back up the ancient wisdom. [No they don’t, and it’s not ancient wisdom.]

It recommends acupuncture for pain, nausea, speeding progress in labor, and treating infertility. It warns against stimulating certain acupressure points in the ankle before term because it can cause uterine contractions. If only! Wouldn’t overdue women and frustrated obstetricians love it if they could bring on labor that easily!

Chiropractic

This therapy uses physical manipulation of the spine and other joints to enable nerve impulses to move freely through an aligned body, encouraging the body’s natural ability to heal. Chiropractic medicine can help pregnant women battle nausea; back, neck, or joint pain; and sciatica (plus other types of pain), as well as help relieve postpartum pain.

Reflexology

Similar to acupressure, reflexology is a therapy in which pressure is applied to specific areas of the feet, hands, and ears to relieve a variety of aches and pains, as well as to stimulate labor and reduce the pain of contractions.

As with acupressure, the book warns against stimulating contractions before term.

Moxibustion

…combines acupuncture with heat (in the form of smoldering mugwort, an herb) to gradually help turn a breech baby.

Aromatherapy

Scented oils are used to heal body, mind, and spirit and are utilized by some practitioners during pregnancy; however, most experts advise caution, since certain aromas …may pose a risk to pregnant women.

Herbal Remedies

At last, a voice of reason: it points out that “natural” is not synonymous with “safe.”

Most experts do not recommend herbal remedies for pregnant women because adequate studies on safety have not yet been done.

But even here it quickly degenerates as it continues,

Even the most traditional ob-gyns are realizing that [CAM] is a force to be reckoned with, and one to begin incorporating into ob-business as usual.

Homeopathy

Homeopathy is inappropriately included under herbal remedies and there is no explanation of what it is or whether it is effective. They only say the safety of the remedies has not been established by any regulatory system so they recommend that it be avoided unless it has been specifically prescribed by a traditional practitioner who is knowledgeable in CAM and who knows you’re pregnant.

The section concludes

CAM can still be strong medicine. Depending on how it’s used, this potency can be therapeutic or it can be hazardous.

Advice for Specific Problems

CAM misinformation pops up in several other sections of the book.

• For labor pain: acupuncture, hypnosis, hydrotherapy, and reflexology.
• For symphysis pubis pain: acupuncture or chiropractic.
• For carpal tunnel syndrome: acupuncture.
• For indigestion: meditation, visualization, biofeedback, or hypnosis.
• And for morning sickness:
  • Try Sea-Bands to put pressure on acupressure points or use a battery-operated ReliefBand that uses electrical stimulation.
  • “Go CAM crazy. There are a wide variety of complementary medical approaches, such as acupuncture, acupressure, biofeedback, or hypnosis, that can help minimize the symptoms of morning sickness — and they’re all worth a try.”

Conclusion

There is no credible scientific evidence to support any of these recommendations. It could be argued that this is all feel-good, “keep-the-patient entertained” advice with little chance of direct harm. But it is deceptive and dishonest to represent these modalities as effective treatments based on science, especially in a book that is otherwise scientifically reliable. It would be interesting to find out whether the coverage of CAM has changed from earlier editions. It could be much worse: at least there is no hint of anti-vaccine propaganda.

It’s an “almost very good” book that I can’t recommend. There is no way for the average reader to separate the accurate science-based information from the misinformation about CAM.  It’s unfortunate that so many women are reading and presumably trusting everything it says.

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About three weeks ago, ironically enough, right around the time of TAM 9, the New England Journal of Medicine (NEJM) inadvertently provided us in the form of a new study on asthma and placebo effects not only material for our discussion panel on placebo effects but material for multiple posts, including one by me, one by Kimball Atwood, and one by Peter Lipson, the latter two of whom tried to point out that the sorts of uses of these results could result in patients dying. Meanwhile, Mark Crislip, in his ever-inimitable fashion, discussed the study as well, using it to liken complementary and alternative medicine (CAM) as the “beer goggles of medicine,” a line I totally plan on stealing. The study itself, we all agreed, was actually pretty well done. What it showed is that in asthma a patient’s subjective assessment of how well he’s doing is a poor guide to how well his lungs are actually doing from an objective, functional standpoint. For the most part, the authors came to this conclusion as well, although their hedging and hawing over their results made almost palpable their disappointment that their chosen placebos utterly failed to produce anything resembling an objective response improving lung function as measured by changes (or lack thereof) in FEV1.

In actuality, where most of our criticism landed, and landed hard—deservedly, in my opinion—was on the accompanying editorial, written by Dr. Daniel Moerman, an emeritus professor of anthropology at the University of Michigan-Dearborn. There was a time when I thought that anthropologists might have a lot to tell us about how we practice medicine, and maybe they actually do. Unfortunately, my opinion in this matter has been considerably soured by much of what I’ve read when anthropologists try to dabble in medicine. Recently, I became aware that Moerman appeared on the Clinical Conversations podcast around the time his editorial was published, and, even though the podcast is less than 18 minutes long, Moerman’s appearance in the podcast provides a rich vein of material to mine regarding what, exactly, placebo effects are or are not, not to mention evidence that Dr. Moerman appears to like to make like Humpty-Dumpty in this passage:

‘When I use a word,’ Humpty Dumpty said, in rather a scornful tone, ‘it means just what I choose it to mean — neither more nor less.’

‘The question is,’ said Alice, ‘whether you can make words mean so many different things.’

‘The question is,’ said Humpty Dumpty, ‘which is to be master — that’s all.’

Let’s dig in, shall we?

The interviewer, Joe Elia, begins by framing the question of the significance of the NEJM placebo/asthma study as asking what matters more, subjective responses of patients or objective responses? Right off the bat, this is a problem for several reasons, the most glaring of which is that it’s a false dichotomy. Both matter, but for different diseases and conditions one can matter more than the other. For example, in the asthma study, as all the SBM bloggers who wrote about it pointed out, objective measures matter a lot. If, for example, a patient with asthma has a very low FEV1, he might still feel OK or have only mild shortness of breath and yet still be just a tiny push away from total respiratory collapse. Another example that comes to mind is diabetes, particularly type I diabetes. Before we had an effective treatment in the form of injected insulin to restore blood glucose levels to something resembling normal, many diabetics, other than symptoms such as thirst and frequent urination, felt more or less fine. Yet they could easily be just a piece a cake away from diabetic ketoacidosis. In such conditions, objective improvement matters, and it matters a lot—far more than subjective symptoms. That doesn’t mean that subjective symptoms aren’t important, but concentrating on the subjective and dismissing the objective can be dangerous. Moerman, not being a physician, seems not to recognize this and doesn’t even address the issue. Indeed, he seems blithely unaware that relying on placebo responses in diseases that produce a real, life-threatening physiological derangement is the way to kill at least a few patients. But they’ll feel great—until right before they crump.

Elia asks Moerman right off the bat what he sees in medical studies such as the NEJM placebo study that’s common to other human situations. Moerman responds:

…I see actors and responders. I see uniforms. I see symbols of power. I see authoritarian and all sorts of other kinds of interactions between people. I see lots of interactions between people. I see lots and lots and lots of meaning.

And I see dead people. (Sorry, couldn’t resist.)

Time and time again, Moerman returns to this word, “meaning.” But what does he—if you’ll excuse the awkward sentence construction—mean when he uses the word “meaning”? Elia asks him just that question, pointing out that the word featured prominently in the title of his book Medicine, Meaning and the “Placebo Effect”. Moerman responds with a bit of a waffle dance before he tries to actually answer the question:

…given that we’re talking to a bunch of physicians, let me start by saying why it is I put “placebo effect” in quotation marks. What we mean ordinarily by “placebo effect” is unproblematic. It’s an inert substance designed to mimic a medical procedure. The key thing is that it’s inert. If it’s inert, what that means is, it can’t do anything. That’s what “inert” means. But there simply can’t be such a thing as a placebo effect. It’s a contradiction in terms, sort of like “king of America.” So, I think that “placebo effect” is like “king of America.” It doesn’t exist. Now, at the same time we all know that if you give people inert medications they often respond dramatically, and they get a lot better. So, the only thing that we know for sure is that it’s not the placebo that did it. So what did do it? And what I argue is that what did it is all of the other meaningful stuff that’s associated with medicine, starting with the behavior of the parking lot attendant, going through the receptionist, to what’s hanging on the walls to the art in hospital. I said in the article, our hospital has two helipads.

When you walk into a place like that you know you’re in a place of great overweaning power. It’s incredibly meaningful. And I would argue that that meaning, that and all sorts of other kinds of meaning—the stethoscope around the neck, the uniforms, the funny white shoes, you know, on and on and on—all of that stuff goes together to create a generic system of meaning which is then sort of instantiated by the specific red or orange or blue pills that the doctor gives you and tells you when to take it this way and that way and to drink lots of water, which is a healing substance all of its own. And the meaning that’s attached to all of that stuff can be at least as powerful as whatever is in the pill, whether it’s inert or not.

Alright, I’ll give Moerman credit for a bit of a sense of humor. That line about his hospital having two helipads wasn’t half-bad. Of course, back when I was doing residency in Cleveland, our county hospital had three helipads. So there. (Actually, the reason it had three helipads is because it was the main base for Metro LifeFlight, where I actually moonlighted as a flight physician for nearly three years while I was in graduate school.) In any event, Moerman seems to miss a huge point. He seems to be arguing that placebo effects come from the atmosphere of medicine; i.e., the lab coats, the halls of “power,” the helipads, the medical jargon, the mysterious language that only medical personnel (the high priests or shamans of whom are, presumably, the doctors) can understand. Here’s the problem. In the NEJM article, the patients in the no-treatment, “watchful waiting” group in the asthma/placebo study experienced all of that medical awesomeness, yet they didn’t feel better. They only felt better after they got either active treatment or placebo treatment. In fact, all that medical awesomeness didn’t affect them very much at all. True, even some of those who received no treatment at all reported feeling better, but that’s not uncommon in a clinical trial, and it was a far fewer number who spontaneously felt better than those who were treated with an albuterol inhaler or placebo treatments. In this study at least, the aura of medicine didn’t do much compared to the actual placebo intervention. Moerman completely missed the point here.

He does a bit better, although not a lot, in one of his articles from 2002 to which he refers in his interview entitled Deconstructing the Placebo Effect and Finding the Meaning Response. After listing studies in which, for example, medical students reported feeling a stimulant response after taking a red placebo and a sedative response after taking a blue placebo; people with headache reported more pain relief after taking a branded aspirin as compared to aspirin in a plain bottle and after placebo aspirin in the same branded bottle compared to placebo in a plain bottle; and it was found that people who were told that exercise would improve their psychological—surprise! surprise!—reported that exercise improved their psychological well-being. In the article, he also tries to have it both ways. While arguing time and time again that placebos, because they are inert, can’t do anything, he takes pains to point out that placebo responses leading to pain relief can be blocked by an opiate antagonist, naloxone, concluding, rather disingenuously in my opinion, “To say that a treatment such as acupuncture ‘isn’t better than placebo’ does not mean that it does nothing.” This is, of course, a massive straw man. If, as Mark Crislip jokes, placebo effects due to CAM are the “beer goggles of medicine,” altering perceived pain and symptoms without actually affecting the underlying physiology, it is not surprising that the brain function might—oh, you know—actually change in response to placebo.

In the podcast, Moerman chooses two more recent studies to try to make his point—and misinterprets them both. First, he cites a famous article from 2009 in which patients were randomized to individualized acupuncture, standardized acupuncture, simulated acupuncture (twirling a toothpick against the skin), and usual care and makes exactly the same mistake interpreting it that CAM practitioners made in trying to promote the study. In essence, he concluded that because sham acupuncture (the toothpicks) did as well as “real acupuncture” and that both did better than usual care that acupuncture “works.” Wrong, wrong, wrong. Moerman then cites a famous German acupuncture study (the GERAC study, published in 2007) as evidence that acupuncture “works” as a “meaningful” intervention. Wrong, wrong, wrong, wrong, wrong as well. This latter study preselected patients with a long history of back pain whose pain didn’t respond well to standard treatment but who were naive to acupuncture. In other words, these studies do not show that “acupuncture works very well for low back pain, much better than standard care” (Moerman’s exact words). In actuality, they showed the exact opposite.

He then mentions a study on depression in which St. John’s wort, sertraline, and placebo all had similar results in depression and asks:

What do you conclude from that study? That nothing has any effect against depression because a placebo was involved. That doesn’t follow.

Actually, yes it does. It does indeed follow. Well, it doesn’t follow that nothing has any effect against depression; rather, it follows that in this study apparently neither sertraline nor St. John’s wort had any effect. This, by the way, appears to be the study to which Moerman referred. If this is the study, then it’s not entirely true that sertraline had no effect different from placebo; it only affected one of three measures of depression, but it demonstrated “much improvement” in that measure. Disappointing, but not “no effect,” and there were a number of potential explanations. The authors note that “Failure of established antidepressants to show such superiority occurs in up to 35% of trials, which illustrates the difficulties plaguing randomized placebo-controlled trials in this population.” They also noted that only 36% of the sertraline group had their dose maximized, pointing out that “if any protocol bias existed at all, it would favor hypericum [St. John's wort], which could be dosed to the maximum of its permissible range, whereas the maximum permitted dose of sertraline was only 50% of its highest recommended amount.” So, in this study, it is reasonable to conclude that neither sertraline nor St. John’s wort “worked” in this population at this time at the doses used, but when the totality of evidence and the shortcomings of this trial are taken into account, sertraline does have an effect.

Another issue that Moerman completely ignores is that placebo responses might very well also be largely influenced by artifacts inherent in the structure of clinical trials. It’s not as though these issues haven’t been heavily studied, including expectancy effects (people are suggestible), observer effects (people often report improvement just from the process of being observed, also known as the Hawthorne effect), observer bias, training effects from repeated testing, and cheerleader effects from being encouraged. One wonders what Moerman would say about recent research, including an (in)famous NEJM meta-analysis and a recently updated Cochrane review, that suggest strongly that, when all these nonspecific effects and experimental biases are controlled for adequately, the placebo effect disappears. I think it’s worth quoting each briefly.

First, the NEJM:

…we found little evidence that placebos in general have powerful clinical effects. Placebos had no significant pooled effect on subjective or objective binary or continuous objective outcomes. We found significant effects of placebo on continuous subjective outcomes and for the treatment of pain but also bias related to larger effects in small trials. The use of placebo outside the aegis of a controlled, properly designed clinical trial cannot be recommended.

Then the Cochrane review:

We did not find that placebo interventions have important clinical effects in general. However, in certain settings placebo interventions can influence patient-reported outcomes, especially pain and nausea, though it is difficult to distinguish patient-reported effects of placebo from biased reporting. The effect on pain varied, even among trials with low risk of bias, from negligible to clinically important. Variations in the effect of placebo were partly explained by variations in how trials were conducted and how patients were informed.

Be that as it may, in a way Moerman (sort of) agrees with Crislip, just not in a way that supports his argument that the “meaning” behind placebos is this wonderful, powerful thing. Crislip makes a strong argument dismissing placebo effects as a myth. Moerman is dismissing placebo effects in a different manner, but in a way infused with his background as an anthropologist. He’s denying placebo effects by renaming them. In a way, they are (again, sort of) arguing the same thing. Crislip argues that placebo effects are an example of mild cognitive therapy in which the pain stays the same but it’s the perception of pain that changes. Moerman argues something similar, ascribing changes in pain perception to all trappings of “power” and interactions with health care providers in medical settings and the “meaning” that patients find in them. None of this is inconsistent with placebo responses being in actuality altered perceptions of symptoms. It’s just that Moerman seems to think that the “meaning” that alters these perceptions is far more powerful than it is. Unfortunately, while Crislip is rooted in hard-nosed “materialistic” science, Moerman seems more rooted in postmodern, relativistic thinking:

Practitioners can benefit clinically by conceptualizing this issue in terms of the meaning response rather than the placebo effect. Placebos are inert. You can’t do anything about them. For human beings, meaning is everything that placebos are not, richly alive and powerful. However, we know little of this power, although all clinicians have experienced it. One reason we are so ignorant is that, by focusing on placebos, we constantly have to address the moral and ethical issues of prescribing inert treatments (73, 74), of lying (75), and the like. It seems possible to evade the entire issue by simply avoiding placebos. One cannot, however, avoid meaning while engaging human beings. Even the most distant objects—the planet Venus, the stars in the constellation Orion—are meaningful to us, as well as to others (76).

One notes that reference #76 is a book by Timothy P. McCleary entitled, The Stars We Know: Crow Indian Astronomy and Lifeways. Perusing the information about the book, I see that the author states very early on that the purpose of his book was to “provide insight into a little known aspect of Crow culture—Crow ethnoastronomy. Ethnoastronomy, a fairly recent development in human sciences, attempts to elicit how non-Western peoples’ perceptions of cosmic phenomena are utilized in structuring behaviors, values, and mores.” All of this might be fascinating reading as far as learning about the history and culture of various peoples, but it would appear to stretch the bounds of what is a science and what it has to do with medicine I’m having a hard time grasping. It must be that reductionistic “Western” scientist in me. Is Moerman trying to say that because humans find “meaning” (whatever that means) in stars and constellations that placebos work? How would understanding “meaning” improve medicine above and beyond what we currently do to understand the effect of patient-provider interactions on health care delivery. Moerman either can’t or doesn’t specify, nor does he provide concrete examples of how his ideas would improve medicine. Maybe he does so in his book, but given that his article to which he referred is billed as the “abstract” or a “synopsis” of his book, somehow I doubt it. Worse, Moerman adds nothing new to the conversation, nor does he provide any testable hypotheses that would allow us to use his concept of “meaning” to better medical care by maximizing nonspecific effects as we use effective medicines.

The lack of specific examples aside, the problem remains for diseases for which there is a real derangement in physiology, such as asthma, diabetes, and the like. If placebo responses make the patient perceive his symptoms as being less severe, that doesn’t help the underlying pathophysiology or work to prevent the very real, very dangerous complications that can result from that pathophysiology. Again, nowhere in Moerman’s editorial or podcast do I see a recognition of that. What I do see is Moerman trying to make like Humpty-Dumpty and make the word “meaning” mean just what he chooses it to mean—neither more nor less, except that, now having read his NEJM editorial and his earlier paper and listened to his podcast interview, I’m still not sure he even knows what it’s supposed to mean.

The bottom line is that we as physicians are indeed called upon to relieve patients’ symptoms, but our obligation goes far beyond that. As physicians, we understand the pathophysiology of disease; we know the consequences of leaving a disease untreated. It is not enough for us to make the patient feel better. If that were the case, then there would be no reason not to give patients sedatives or stimulants for almost everything. Those certainly “make patients feel better”! But there are a lot of conditions where physiology trumps subjective complaints, or at least threatens to. Asthma, the topic of the NEJM placebo study from last month, is, of course, a classic example. A patient can be feeling fine (or at least not too bad) but be perilously close to a respiratory arrest. The same is true of diabetes, where a more or less asymptomatic patient can be on the verge of diabetic ketoacidosis. In these cases, our obligation as physicians is not just to make the patient feel better, but to make the patient better.

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