Background

This post concerns the recent article in the New England Journal of Medicine (NEJM) titled “Active Albuterol or Placebo, Sham Acupuncture, or No Intervention in Asthma.” It was ably reviewed by Dr. Gorski on Monday, so I will merely summarize its findings: of the three interventions used—inhaled albuterol (a bronchodilator), a placebo inhaler designed to mimic albuterol, or ‘sham acupuncture’—only albuterol resulted in a clinically important improvement of bronchial airflow; for that outcome the two sham treatments were equivalent to “no intervention.” For all three interventions, however, self-reported improvements were substantial and were much greater than self-reported improvements after “no intervention.” In other words, dummy treatments made the subjects feel better, whereas real medicine not only made them feel better but actually made them better.

Before proceeding, let me offer a couple of caveats. First, the word ”doctors” in the flippant title of this post refers mainly to two individuals: Daniel Moerman, PhD, the anthropologist who wrote the accompanying editorial, and Ted Kaptchuk, the Senior Author of the trial report itself. It does not refer to any of the other authors of the report. Second, I have no quarrel with the trial itself, which was quite good, or with the NEJM having published it, or even with most of the language in the article, save for the “spin” that Dr. Gorski has already discussed.

My quarrels are the same as those expressed by Drs. Gorski and Novella, and by all of us on the Placebo Panel at TAM. This post and the next will develop some of those points by considering the roles and opinions of Moerman and Kaptchuk, respectively.

A True Story

Late one night during the 1960s a friend and I, already in a cannabis-induced fog, wandered into a house that had been rented by one of his friends. There were about 8-10 ‘freaks’ there (the term was laudatory at the time); I didn’t know any of them. The air was thick with smoke of at least two varieties. After an uncertain interval I became aware of a guy who was having trouble breathing. He was sitting bolt upright in a chair, his hands on his knees, his mouth open, making wheezing sounds. He took short noisy breaths in, followed by what seemed to be very long breaths out, as though he was breathing through a straw. You could hear the wheezing in both directions. Others had also noticed that he was in distress; they tried to be helpful (“hey, man, ya want some water or somethin’?”), but he just shook his head. He couldn’t talk. My friend, who had asthma himself, announced that this guy was having an asthma attack and asked if he or anyone else had any asthma medicine. No one did.

No one had a car, either, and for obvious reasons no one, not even the wheezing guy himself, was about to call 911. The nearest hospital was about 5 miles away. My friend said that the thing to do when someone has an asthma attack is leave him alone so he won’t get too excited, and he’ll get through it. Yeah, that must be right, we all figured; he has asthma too so he knows. We were all blowing smoke into the wheezing guy’s face as we expressed our concern.

At some point my friend and I left. The next day I heard that the guy with the asthma attack was eventually taken to the ER after another freak had come along who happened to have a car. The guy did alright, I guess. I don’t really know, but if he’d died I probably would’ve heard about it.

Several years later I went to medical school and began to learn about asthma, and as an internal medicine resident I saw enough patients with acute asthma attacks to realize, in a way that still makes me cringe, just how sick that guy had been and how totally clueless and selfish were we, his supposedly concerned companions. If the freak with the car hadn’t shown up…

Cultural Anthropology and Cultural Relativism

All of which has something to do with the surprise I felt a few days ago upon reading the following in the aforementioned editorial in the NEJM, the world’s most prestigious medical journal:

For subjective and functional conditions — for example, migraine, schizophrenia, back pain, depression, asthma, post-traumatic stress disorder, neurologic disorders such as Parkinson’s disease, inflammatory bowel disease and many other autoimmune disorders, any condition defined by symptoms, and anything idiopathic — a patient-centered approach requires that patient-preferred outcomes trump the judgment of the physician. Under these conditions, inert pills can be as useful as “real” ones…

Let’s see: asthma is a “subjective and functional condition”? In the bad old days of paternalistic medicine, the term “functional” meant “without demonstrable pathology.” It was usually synonymous with ”in your head”—whether the physician openly expressed that opinion or not. Doesn’t sound very “patient-centered” to me. I’m happy to report that you hardly ever hear ”functional” anymore, which reflects at least some measure of social progress for the profession. Since the term’s other possible meanings are nearly limitless and therefore vague beyond utility—every complaint or medical condition is in some way “functional,” after all—it seems reasonable to assume that the editorial’s author intended the old meaning, even if it and “subjective” are redundant.

Yet asthma is based in demonstrable pathology, as are most of the other named conditions, and in most of those (migraines, Parkinson’s disease, inflammatory bowel disease, and “many other autoimmune disorders”) there are specific treatments based on pathophysiology that, like albuterol for asthma, effect substantial, objective and subjective improvements. ”Idiopathic” refers to any condition whose cause is unknown, which includes most of those already mentioned and many other diseases for which medicines are effective for both objective and subjective outcomes (diabetes, Grave’s disease), and even some that are, for practical purposes, curable: Hodgkin’s disease, acute lymphocytic leukemia in children, some testicular cancers (remember Lance?), temporal arteritis, pernicious anemia, and many more. How could the author of a NEJM editorial be unaware of such commonplace medical facts?

The answer is that the author, Daniel Moerman, is not a doctor or even a biomedical scientist. He’s an anthropologist who seems to have confused sentimental and poetic aspects of his major academic interests—native American culture, medicinal plants, and healing rituals—with modern science and medicine. I urge you to consider his CV and the excerpts from his book Medicine, Meaning and the “Placebo Effect,” discussed by Dr. Gorski a few days ago. In the very first chapter he betrays more ignorance of medicine when he expresses surprise that a gastroenterologist didn’t find it odd that in a cohort of experimental subjects given only placebos for peptic ulcer disease, nearly half demonstrated healed ulcers after 4 weeks—about the percentage, I’d wager, whose ulcers would have healed with no trial intervention.

Regarding Prof. Moerman’s view of the sort of science that physicians need to know, along with Dr. Gorski I detect shades of Deepak Chopra, although I also detect a bit of down-home, folksy, isn’t-he-wise midwestern ambiguity, possibly delivered in a Mr. Ed voice, such as to give the good professor a way to deny it all. Consider this excerpt from the NEJM editorial, also noted by Dr. Gorski:

What do we learn from this study? The authors conclude that the patient reports were “unreliable,” since they reported improvement when there was none — that is, the subjective experiences were simply wrong because they ignored the objective facts as measured by FEV₁. But is this the right interpretation? It is the subjective symptoms that brought these patients to medical care in the first place. They came because they were wheezing and felt suffocated, not because they had a reduced FEV₁. The fact that they felt improved even when their FEV₁ had not increased begs the question, What is the more important outcome in medicine: the objective or the subjective, the doctor’s or the patient’s perception? This distinction is important, since it should direct us as to when patient-centered versus doctor-directed care should take place.

Does he really believe that the subjective is the more important outcome? It certainly seems so; next he writes:

In a number of other trials in which both sham and actual treatments were evaluated, results were very similar. In one study of major depressive disorder, placebo, hypericum (St. John’s wort), and sertraline all resulted in about the same level of improvement on the Hamilton Rating Scale for Depression. Similarly, in studies of low back pain in both the United States and Germany, true acupuncture and sham acupuncture had about the same effectiveness yet were substantially better than usual medical care in relieving the pain. A number of surgical procedures — such as arthroscopic knee surgery and spinal vertebroplasty — have led to similar results with actual and sham treatments. In these studies and many more, inert treatments have had effects similar to their “active” analogues.

Woah! Sure, the subjective results of those trials “were very similar” to those of the albuterol trial, but so what? What distinguishes those trials from the albuterol trial is that there were no objective outcomes to measure! Moerman has missed the point of the distinction. He seems to prefer that medicine be about “a profound meaning response,” as he explained in an article written jointly with homeopath Wayne Jonas a few years ago, which comes awfully close to asserting that all “healing” is culturally determined:

Anthropologists understand cultures as complex webs of meaning, rich skeins of connected understandings, metaphors, and signs. Insofar as 1) meaning has biological consequence and 2) meanings vary across cultures, we can anticipate that biology will differ in different places, not because of genetics but because of these entangled ideas…

In the NEJM editorial Prof. Moerman doesn’t seem bothered by an inconvenient truth about objective outcomes. That is, maybe he doesn’t:

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

Prof. Moerman, what about the harm that comes from the NEJM seeming to judge treatments that offer favorable subjective outcomes as being equivalent to those that offer favorable objective outcomes? This kind of harm, for example. Asthma isn’t just a “subjective and functional condition,” whatever that is. It’s a real and potentially lethal disease. Oh, but you wrote “maybe.” Silly me.

Dr. Drazen, Where art Thou?

It is especially puzzling, considering the identity of its Editor-in-Chief, that the New England Journal of Medicine asked Daniel Moerman to write the editorial to accompany the report of the albuterol study. Jeffrey Drazen is not only a pulmonologist, but an expert in the pathophysiology of asthma. He has been instrumental in developing new drugs for asthma, drugs whose effects—I’m willing to bet, but I’ve no time to research right now—have been demonstrated objectively. If memory serves, Dr. Drazen trained at the old Peter Bent Brigham Hospital under ‘Reggie’ McFadden, whose chapter on asthma in my 2001 edition of Harrison’s Principles of Internal Medicine includes this passage:

The most effective treatment for acute episodes of asthma requires a systematic approach based on the aggressive use of sympathomimetic agents and serial monitoring of key indices of improvement. Reliance on empiricism and subjective assessment is no longer acceptable.

I’d be surprised if Dr. Drazen had ever heard of Moerman before the albuterol report was accepted for publication, and I wonder who recommended him. Kaptchuk, perhaps? Heh.

Unfortunately, someone isn’t minding the NEJM store when it comes to certain dubious topics, as Dr. Gorski mentioned and as I’ve written about previously.

Good News, Bad News

Perhaps Dr. Drazen imagines that the editorial won’t do any real damage, because real doctors will immediately identify it for what it is: Bullshit. That is probably true, except for the small but possibly growing number of “integrative” aficianados out there. I worry more about other Dummy Docs, such as naturopaths (ND=Not a Doctor, according to one apostate), who already believe wholeheartedly what Prof. Moerman “maybe” believes, and a lot more:

For an acute asthma attack try a steam inhalation (draping a towel over your head and a bowl of hot water) with a few drops of eucalyptus oil in the water. Be careful that the water is not so hot that the steam burns your face.  Some doctors recommend taking baths with a cup or so of 3% hydrogen peroxide in the water to bring extra oxygen to the entire surface of the skin, thus making the lungs somewhat less oxygen hungry. This method  can be performed preventively. Another technique for an acute attack is to drink some hot water with the juice of one clove of garlic. [etc.]

And:

How Can Homeopathy Help Asthma?
Like with Traditional Chinese Medicine, each individual is analyzed for their specific symptoms and an appropriate  therapy is chosen, not for the disease, but for the person displaying signs of health out of balance.  This is a very  important distinction, and, very generally speaking, one of the main differences between conventional and  “complementary” approaches to health care.

After the homeopath, naturopath or medical doctor trained in homeopathy (they should have the title “Diplomat  of Homeopathy” after their other credentials) listen carefully to your story, one of the following remedies are likely to  be prescribed. [etc.]

What Kind of Subtle Energy Techniques Are Useful for Asthma?
Some folks like to work with flower essences.  Some of the more popular ones to help with asthma are:

• oak
• mimulus
• larch
• wild rose
• hornbeam
• crab apple
• impatiens
• gentian
• Shasta daisy
• blackberry
• chamomile
• agrimony
• clematis

Other people find it useful to work with color, either by using thin plastic filters over light sources in their home or office environment, or by wearing clothes of specific colors.  The following serves as a guide to experiment with color therapy to help asthma.

During an asthma attack try:

• purple (raises the threshold of pain and is soporific; is a vasodilator; slows heart rate) on face, throat and chest
• scarlet (acts as a stimulant to the kidney and adrenals) on kidneys
• orange (an antispasmodic) on throat and chest
• indigo or violet on throat, chest and upper back for 15 minutes

Etc., ad nauseam. Boy, do Dummy Docs love it when their pet treatments seem to be endorsed by real medicine, especially the highest bastions of real medicine. Science, even! Is it any surprise when something like this happens? Josephine Briggs, are you reading this? If so, please look here for more discussion of that case. You also won’t want to miss the sequel to this post.

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