As most readers of the blog know, I am mostly an Infectious Disease doc. I spend my day diagnosing and treating infections and infectious complications. It is, as I have said before, a simple job. Me find bug, me kill bug, me go home. Kill bug. It is the key part of what I do everyday, and if there is karmic payback for the billions of microbial lives I have erased from the earth these past 25 years, my next life is not going to be so pleasant. I will probably come back as a rabbit in a syphilis lab.

It is always fun when my hobby, writing for SBM, crosses paths with my job. This month the Annals of Internal Medicine published “Oseltamivir Compared With the Chinese Traditional Therapy Maxingshigan–Yinqiaosan in the Treatment of H1N1 Influenza. A Randomized Trial.”

I though big pharma was good at coming up with names I do not know how to pronounce. If someone could provide a pronunciation guide in the comments, it would be ever so helpful, so I will not have to embarrass myself when this entry becomes a Quackcast. Dr. Hall wrote about this article on Tuesday, and I have avoided reading her post until this one is up, so there may be overlap in what is discussed.

What is Maxingshigan–Yinqiaosan (MY)? Twelve herbs, one better than the Colonel (and speaking of pronunciation, why is it pronounced “kernel”?) but lacking the spices. It contains

zhimahuang (honey-fried Herba Ephedrae), 6 g; zhimu (Rhizoma Anemarrhenae), 10 g; qinghao (Herba Artemisiae Annuae), 15 g; shigao (Gypsum Fibrosum), 30 g; yin- hua (Flos Lonicerae Japonicae), 15 g; huangqin (Radix Scutellariae), 15 g; chaoxingren (stir-baked Semen Armeniacae Amarum), 15 g; lianqiao (Fructus Forsythiae), 15 g; bohe (Fructus Forsythiae), 6 g; zhebeimu (Bulbus Fritillariae Thunbergii), 10 g; niubangzi (Fructus Arctii Tosum), 15 g; and gancao (Radix Et Rhizoma Glycyrrhizae), 10 g.

Quite the melange of products. Could there be antiviral or immunomodulating molecules in such a hodgepodge? Certainly. There is no a priori reason that Maxingshigan–Yinqiaosan would, or would not, have efficacy against influenza or its complications.

The reasons to test MY are partly appeals to antiquity, “Traditional Chinese medicine has been used to treat seasonal influenza for thousands of years,” plus a reference that, upon searching, does not contain the word influenza. Or pneumonia. Or respiratory tract infection.

You have to wonder, when you are in the second paragraph of the introduction and looking up the primary sources and they do not match the text, just how careful the researchers and the editors of the journal are. It’s the Annals. Not very. Which is why my subscription lapsed. And, to demonstrate just how infantile I can truly be, when I discuss the journal with residents, I pronounce it as if it had one ‘n’. But do not accidentally type in the url at work with Annals spelled with one ‘n’; I discovered our firewall filter has an Anals.org weakness.

In Europe, pandemic influenza has been recognized for perhaps 500 years: “Then suddenly, in July and August 1510, a ‘gasping oppression’ with cough, fever, and a sensation of constriction of the heart and lungs began to rage, seemingly everywhere at once.” And local flu has been known for maybe 650 years. Given those numbers, “thousands of years” seems a wee bit of hyperbole, especially when the reference doesn’t support the assertion. And as best I can tell from the Googles, no influenza was reported in China until the 1800s, and given traditional diagnostic testing modalities, I doubt they were looking at patterns of disease that would be identified today as influenza.

Then they say

In a recent meta-analysis of 31 randomized clinical trials including 5514 cases of influenza, the authors concluded that TCM had significantly increased clinical efficacy compared with placebo or no intervention.

And that analysis was? A systematic review of chuanhuning for acute respiratory tract infections. Chinese Archives of Traditional Chinese Medicine. 2007;25:2200-3.

The abstract said “There were 31 RCTs with 5514 cases were involved.” 5514 cases of acute respiratory tract infections, not 5514 cases of influenza.  Although I may be slapped down for this, as the original is in Chinese and there is nothing on the Pubmeds relating to chuanhuning.

Looking for the primary references of the systematic review as best as I could given the language issues, the Googles find “etiological diagnosis by clinical experiments and tissue civilization experiments show namely the product of inactivated influenza virus A type ?, ? type A, pneumonia, adenovirus (Adv) ? type, ? type, intestinal syncytial virus and respiratory syncytial virus (Rsv) have inactivation” and the few trials I could locate were for a hodgepodge of viral and other upper and lower respiratory infections.

Chuanhuning is not in the current regimen to be tested, and the authors of the systemic review mention “the evidence is not strong due to the general poor methodological quality.”

The argument, not supported by the references, for testing MY is: product A may work for influenza, so let’s try an entirely different product for influenza. Could the editors of the Annals be doing a worse job at reading the papers in their journals?

They then mention “Modern pharmacologic studies demonstrated that some TCM formulas had antiviral and immunomodulating effects (13, 14).” Reference 13 is Chen N, Ren L. [Modern pharmacology research and clinical use of max- ingshigan]. Academic Journal of Guang Dong College of Pharmacy. 2004;545-6. and reference 14 is Huang JM, Chen DP, Yang LP. [The immunomodulating effects of maxingshigan on asthma mice models]. Journal of Fujian Traditional Chinese Med- icine. 2003;34:38-9. At least both references have maxingshigan in the title, but whether the content matches the assertions, well, let’s say their credibility has not been demonstrated.

Of course, no study of “Eastern” medicine would be complete without the appeal to popularity:

During the early days of the 2009 H1N1 influenza A pandemic, the popular herbal formula maxingshigan–yinqiaosan was used widely by TCM practitioners to reduce symptoms.

Years ago, at conference, one of my attendings was being detailed about a new antibiotic, and the rep finished up with “and it is popular in Europe.” To which my attending replied “So was Hitler for a while.” A pre-Interweb version of Godwin’s Law.

Searching for Maxingshigan–Yinqiaosan in the Pubmeds yields little but the intriguing, yet unavailable, Two hundred and thirty-five cases of high fever caused by exopathogen treated with yinqiao maxing shigan tang.

I went through the tedium of searching each component of MY in the Pubmeds and its relationship to influenza and found nothing of note.

So the reason for the study, really, is that people were using it. Let’s see if it really works.

They randomized people with mild PCR proven influenza to

Oseltamivir, 75 mg twice daily; maxingshigan– yinqiaosan decoction (composed of 12 Chinese herbal medicines, including honey-fried Herba Ephedrae), 200 mL 4 times daily; oseltamivir plus maxingshigan–yinqiaosan; or no intervention (control). Interventions and control were given for 5 days.

Primary outcome was time to fever resolution. Secondary outcomes included symptom scores and viral shedding determined by using real-time reverse transcriptase polymerase chain reaction.

It was not blinded, only a small flaw given the endpoint, and most patients did not receive an intervention until relatively late in the disease, when the impact would be lessened

In our study, the median time from onset of illness to randomization was 34.5 hours; 23.2% of patients presented 48 to 72 hours after the onset of symptoms.

Sooner is better with the treatment of all acute infections, and given the delay in therapy, they are approaching a natural history of disease study more than a therapeutic intervention study.

They found

Significant reductions in the estimated median time to fever resolution compared with the control group (26.0 hours [95% CI, 24.0 to 33.0 hours]) were seen with oseltamivir (34% [95% CI, 20% to 46%]; P < 0.001), maxingshigan–yinqiaosan (37% [CI, 23% to 49%]; P < 0.001), and oseltamivir plus maxingshigan– yinqiaosan (47% [CI, 35% to 56%]; P < 0.001). Time to fever resolution was reduced by 19% (CI, 0.3% to 34%; P < 0.05) with oseltamivir plus maxingshigan–yinqiaosan compared with oseltamivir. The interventions and control did not differ in terms of decrease in symptom scores (P < 0.38).

The actual numbers: control had fever for 26 hours, oseltamivir for 20, the MY 16 and the oseltamivir plus MY was 15, in real numbers the results are almost clinically irrelevant. And the treatment groups were randomized later than the no treatment group, and temperatures measurement started at randomization. So if the treatment groups have a head start in temperature measurement, that wipes out at mostly of the therapeutic advantage doesn’t it? Most of the difference due to when they started counting.

If you measure from symptom onset to resolution of fevers, you get

Control: 56 hours
MY: 51 hours
Oseltamivir: 55 hours
MY plus oseltamivir: 47 hours

It is the duration of illness that is clinically the important feature, so even if the effects are statistically significant, the difference is not clinically significant.  And besides fever, there was no improvement in other symptoms: “No difference in any individual symptom, including cough, sore throat, headache, or fatigue, was observed after treatment.” Fever often remits before other symptoms of influenza, and given the duration of illness, from a clinical perspective, none of the interventions did much of anything.

As to viral shedding

the median viral titer in throat swabs at enrollment was similar, and a rapid decrease in virus shedding was observed in all 4 groups (P < 0.001) Changes in virus shedding from baseline to day 5 did not differ by treatment group (P < 0.69 for time-by-treatment interaction).
Both baseline swab specimens and specimens collected on days 1 to 5 for evaluation of virus shedding were available for 148 participants. Compared with the 262 patients without viral shedding measurements, these 148 patients had lower symptom scores; a lower proportion of cough, headache, and fatigue; lower leukocyte counts; and longer time from onset of illness to randomization. Therefore, the virus shedding results from these 148 patients were not representative of the entire study population

But when you look at the actual curves,

there is separation between the oseltamivir containing regimens and those without, with the MY closer to the control. It suggests that the effect of MY is anti pyretic/immunomodulatory rather than antiviral. And given that the control group started the PCR measurements earlier as well, yo would expect slighly higher viral levels. If there is an effect from MY, it is a small one, and it appears to be less antiviral and more antipyretic, although the authors state

The study could not determine whether the observed effects of maxingshigan–yinqiaosan were due to anti- pyretic or antiviral effects.

I bet the former.

Given that the patients were all healthy, had mild illness and were treated relatively late in the disease, I would expect to any intervention to have a modest effect, and theirs was modest indeed.

Non sequitur central continues in the discussion where they discuss potential mechanisms of action and note

During the outbreak of the severe acute respiratory syndrome in Hong Kong, Poon and associates (24) showed that 2 herbal formulas had immunomodulating effects. In their study of healthy volunteers, they found that the CD4 –CD8 ratio of T lymphocytes was significantly increased after participants received Chinese herbal medicine for 14 days (24).

The reference, Immunomodulatory Effects of a Traditional Chinese Medicine with Potential Antiviral Activity: A Self-Control Study, states

We investigated the immunomodulating effects of an innovative TCM regimen derived from two herbal formulas (Sang Ju Yin and Yu Ping Feng San) for treating febrile diseases.

I am limited by language, variability in TCM medications and lousy editors at the Annals, but apparently Sang Ju Yin is Mulberry & Chrysanthemum Pills and Yu Ping Feng San, or Jade Screen Teapills, and neither have any ingredients in common with MY.

Sang Ju Yin and Yu Ping Feng San has to do with the mechanism of MY how? That is the kind of discussion the Annals has for its readers: randomness. Linear, logical thought appears passé these days. The authors seem to think all TCM are the same, and there is no reason to differentiate one TCM over another for mechanism of action: “More studies are needed to clarify the mechanisms of TCM.”

Me and my reductionist Western approach, thinking that different products, with different constituents, are actually different, with perhaps different, unrelated mechanisms of action, if they have a mechanism of action at all.

There were articles, again not available in English, that demonstrate in vitro effects of shigan on influenza A. That the references indeed demonstrate what the authors purport, well, I will have to trust the researchers and the editors of the Annals. They have done a fine job to date.

It would appear from one abstract, that 31.25 mg/ml of maxing shigan had multiple effects on viral replication in the test tube and that 31.25 mg/ml was the optimal concentration of the product.

In the study patients received 200 mL of MY orally 4 times daily. So for fun, assume 100% bioavailabilty. Lets assume 31.25 mg/ml in the preparation the patients received. Who knows. 200 x 31.25 is 6250 mg. A human volume is about 70,000 mls.  Assuming a uniform volume of distribution, that gives the concentration of MY at 0.089 mg/ml. Seems a wee bit below the needed MIC. Of course, a lot of assumptions in the calculation, mostly around the concentration of the medication, its absorption and the volume of distribution. The first and third were guesses, the second was probably a large overestimation (medications are rarely 100% absorbed). The real concentrations of MY are probably much less that 0.089 mg /ml.

50% alcohol will also inactivate influenza in vitro. Outside of a frat party, those levels are not achievable in vivo. Always the issue of going from in vitro to in vivo studies

The authors finish up with

In conclusion, in previously healthy young adults and adolescents who presented with uncomplicated 2009 H1N1 influenza A virus infection, therapy with oseltamivir and maxingshigan–yinqiaosan (alone and in combination) was associated with faster resolution of fever. Maxingshigan– yinqiaosan can be used as an alternative treatment of H1N1 influenza A virus infection when oseltamivir is not available.

and the abstract, which is all most people will read, ends with

These data suggest that maxingshigan– yinqiaosan may be used as an alternative treatment of H1N1 influenza virus infection

So here is where I am going to get picky.

My take, looking at the PCR data, is that MY does not treat influenza. There is no real change in the PCR viral concentrations. When you treat an infection, you kill it, or at least prevent it from reproducing. They did not treat influenza, they treated an epiphenomena of influenza, the fever. Treating fever is not the same as treating infection. And of course, it looks like the effect is an artifact of when they started counting, and given the lack of response of other symptoms, this is a mostly a natural history of influenza study.

And should you treat fever? Well, no. There is an interesting literature, with many a methodological issue, that suggests treating a fever is not a good idea.

In animal models and human studies, treating a fever is associated with prolonged illness and, depending on the study, increased mortality. There is no definitive study, but an hour of perusing the literature will show an interesting pattern. Fevers are usually good. Treating fevers is usually bad.

Fevers are an important and ancient response to infection. Most parts of the immune system function better at higher temperatures. Sometimes the patient lacks the physiologic reserve to cope with the metabolic demands of fever (poor cardiac or lung function) and strokes and heart attacks may be larger if the patient has a fever. So sometimes you need to treat fevers. But for most acute infectious diseases that have been evaluated, patients  and animals that have their fever suppressed are have a more prolonged illness, more complications, or increased mortality.

I never treat my kids fevers. They make less noise when they are 102 and will probably resolve their infection faster if I let the fever go, and that will get them to school and me to work that much sooner. Of course, when my wife takes over, she gives them Tylenol. No man is a hero to his valet. Not that my wife is my valet. It is a saying.

I could find no specific data regarding outcomes in treating influenza associated fevers, but I expect like most other infections, it would be a bad idea. And there is always that point in the inflammatory response where the beneficial effects are overwhelmed by the adverse effects of too brisk a response: SIRS, sepsis, TSS and the ever popular cytokine storm, although the fever per se is not issue in those processes.

What annoys, and concerns me at the end, is the confusion between treating influenza and treating the symptoms of influenza. The first was not demonstrated, the second perhaps was and is usually a bad idea.

Conclusion

The effects of MY on fever are probably not real, and if real are mostly clinically irrelevant and probably counterproductive for the treatment of influenza.

As to the mechanics of the paper (proper use of references, critical thinking), if it were from a college student, I would give it a ‘C’.  If it were from a resident on service? Flunk.

And the Annals? In my professional lifetime they have gone from a first tier journal to second tier to now? Now, I shed a tear. Almost as funny as Fail Blog.

<!--<!--

There is quite a bit of art to the practice of medicine: knowing how to get and to give information to a patient, how to create a sense of worry without creating a feeling of panic, how to use the best available science to help them maintain or return to health.  Underlying all of the art is the science: what blood pressure is likely to be harmful in a particular patient?  What can I offer to mitigate this harm?  This science is developed over years by observation and systematic study.  We have a very good idea of what blood pressure levels are optimal to prevent heart attacks in various populations.  These data are hard-won.  It has taken decades and it continues.

If a researcher were to discover a promising, new blood pressure intervention, they would have a long way to go from bench to bedside.  They would have to prove as well as possible that it is safe and effective—and from a science-based medicine perspective, that it is even plausible.  If the discovery is a drug that relaxes blood vessels, or a type of exercise, we have good reason to believe it might work and can go on to figuring out if it does work.  If the intervention is wearing plaid every day, we have little reason to think this would be effective, and it probably isn’t worth the time and cost of looking into it.

The well-respected journal Cancer has just wasted space in the study of wearing plaid.  Well, not really; it’s worse than that.  The article is called, “Complementary medicine for fatigue and cortisol variability in breast cancer survivors: A Randomized Controlled Trial.”  There is nothing that isn’t wrong with this study, and if it weren’t published in a major journal, it might even be light comedy.

Tragedy wins the day, however, because cancer is a big deal, and I don’t like it when people mess around with cancer.

People with cancer suffer from a number of vague and specific discomforts related to the disease and its treatment.  Everything from life-threatening blood clots, to intractable pain and nausea, to depression threaten to kill or disable people with cancer.  One symptom common to many illnesses is fatigue, and during chemotherapy, fatigue can be debilitating.  This new “study” allegedly investigates an intervention to alleviate fatigue.

Fatigue is one of those symptoms whose study can be difficult and deceptive.  It rarely has a single cause, is subjective, and waxes and wanes naturally.  Because of this natural variability, it is easy to attribute changes in fatigue to an intervention when if fact we may be observing the natural course of the symptom.  My patients with colds often want antibiotics.  Without antibiotics, their cold will likely last a week or two; with them, 7-14 days.  If I give them antibiotics, they will certainly credit me with curing their cold, but were I to take credit I would be riding nature’s coattails.

In the current study, the authors have chosen to ride the coattails of nature but rather than cling to them with medicine, they have chosen “biofield therapy”.  My spell checker doesn’t recognize “biofield” and neither should you.  The authors at least acknowledge this in passing:

Biofield therapies are complementary and integrative medicine modalities often used by breast cancer patients,
and have been described as therapies that are intended to affect energy fields that purportedly surround and penetrate the human body for the purposes of healing. (Emphasis mine, PalMD)

I have a big problem with studies built around something that only purportedly exists. What’s next, a study of cancer rates in Sasquatch?

This paragraph effectively nullifies everything that follows, but what follows is so horrid and humorous that we can’t just stop here.

The “biofield healing” technique chosen for the study?  ”Energy Chelation”.  It’s almost as if they looked for a term that took all of quackery and combined it into two simple words.  Nowhere does it tell us what sort of “energy” is being “chelated”; so I looked it up.

According to the study, the technique was chosen by one of the authors, Reverend Rosalyn L. Bruyere.  Is she an oncologist?  A physicist?

Rosalyn L. Bruyere is an internationally acclaimed healer, clairvoyant and medicine woman.

You don’t need to be a capital-S Skeptic to translate that as “con-artist”, although that would simply be an opinion.  The real question isn’t whether or not she is a con-artist (she may in fact be very sincere despite a website that makes her look like a cult leader) but why in the world any real physician or scientist would take such a person seriously?

Still, I want to know what the hell “energy chelation” is. It’s not an easy question to answer, but various searches describe it as a hands-on energy healing technique that, analogous to chelation therapy, “chelate” and remove negative energies from the body.  In other words, it’s a fantasy spun out of happy thoughts and a juvenile imagination.

The “science-y” bit of the study isn’t any better, relying of famously inaccurate “saliva cortisol” measurements, and something called “cortisol variability”, which does not appear to be a validated marker of the symptom in question (fatigue).  From my reading, I’m unclear that it’s ever been validated to measure anything.

For all I know, the editors of Cancer are detoxifying themselves in a sweat lodge to rid themselves of the embarrassment of publishing such dreck.  I just hope they remember to drink lots of water—faith healers do not have a great track record for patient safety.
References

Jain S, Pavlik D, Distefan J, Bruyere RR, Acer J, Garcia R, Coulter I, Ives J, Roesch SC, Jonas W, & Mills PJ (2011). Complementary medicine for fatigue and cortisol variability in breast cancer survivors: A Randomized Controlled Trial. Cancer PMID: 21823103

<!--<!--

Via the magic of “legislative alchemy,” state legislatures transform implausible and unproven diagnostic methods and treatments into perfectly legal health care practices.[1] Without the benefit of legislative alchemy, chiropractors, naturopaths, homeopaths, acupuncturists and other assorted putative healers would be vulnerable to charges of practicing medicine without a license and consumer fraud. Thus, they must seek either their own licensing system or exemption from licensing altogether.

Licensing bestows an undeserved air of legitimacy on “alternative” practitioners. Because a state’s authority to regulate health care lies in its inherent power to protect the public health, safety and welfare, the public understandably assumes licensing actually accomplishes this purpose. In fact, the opposite occurs. Any attempt to impose a science-based standard of health care becomes impossible when vitalism and similarly debunked notions of human functioning are enshrined into law.

Initial licensing is just a beginning. Once the beach head is established other benefits can follow, such as expansion of the scope of practice. If not granted in the initial legislation, “alternative” practitioners can return, seeking more goodies like self-regulation and mandatory insurance coverage.

Each year brings a fresh round of eager petitioners to the state house doors hoping to transform their base ideas into licensing gold through legislative alchemy. In this post, we look at how the naturopaths are faring. We’ll leave chiropractors, acupuncturists and the rest to a later post.

Naturopathy 101

Three years ago, Dr. Kimball Atwood wrote an excellent series of SBM posts on naturopathy, including efforts to license naturopaths in several states (In four parts: 1, 2, 3, 4)[2] Since then, naturopathy has fairly regularly appeared on SBM, its pseudoscientific practices and threats to public health offering plenty of grist (gluten-free or not) for the scientific mill in posts by Drs. Gorski (also this one), Lipson, and Kroll.

All posts are highly recommended, but if you’re pressed for time, here’s Dr. Gorski’s description of naturopathy:

…a hodge-podge of mostly unscientific treatment modalities based on vitalism and other prescientific notions of disease. As a result, typical naturopaths are more than happy in essence to ‘pick one from column A and one from column B’ when it comes to pseudoscience, mixing and matching treatments including traditional Chinese medicine, homeopathy, herbalism, Ayurvedic medicine, applied kinesiology, anthroposophical medicine, reflexology, craniosacral therapy, Bowen Technique, and pretty much any other form of unscientific or prescientific medicine that you can imagine.

As well, according to a recent article in Maternal and Child Health Journal “published reports suggest that only a minority of naturopathic physicians actively support full vaccination.”[3] This should surprise no one, as it fully accords with naturopathy’s long standing opposition to vaccination (see also QuackWatch).

A review of Washington state insurance records reported in the article showed that children were significantly less likely to receive each of four recommended vaccinations (measles/mumps/rubella, chickenpox, diphtheria/tetanus/pertussis, and H. influenzae type B) if they saw a naturopathic physician. It would naturally follow then that pediatric use of naturopathy was associated with significantly more diagnoses of vaccine-preventable disease.

The Scorecard

In the first half of 2011 alone, bills to license naturopaths were pending before ten state legislatures. To date, only one has been successful, in North Dakota. Licensing bills failed in four states because they never made it out of committee. They remain pending in committee in five states.

Of the 15 states already licensing naturopaths, bills to expand the scope of practice (including expansion via self-regulation) were introduced in seven. These bills remain pending in two states, passed in two states, and failed in three states, again because they never made it out of committee. (A bill to expand naturopathic scope of practice is also pending in Washington, D.C.) Legislation mandating public and/or private health insurance coverage for naturopathic services is pending in one state, and failed to make it out of committee in two.

Licensing happens

In July, 2008, Dr. Atwood began the first of his four-part series, “Another State Promotes the Pseudoscientific Cult that is ‘Naturopathic Medicine,’” with the observation that Minnesota had just become the 15th state to license naturopaths. In July, 2011, North Dakota became the 16th state.[4]

North Dakota departs from those states giving naturopaths their own governing authority by establishing a State Board of Integrative Health Care. “Integrative health care,” that ever shape-shifting term, is not defined in the statute, but the Board appears to be a place to park things the state otherwise doesn’t know exactly what to do with. For starters, the Board will license and regulate both naturopaths and music therapists, but the barn door is left open for other “integrative” health care practitioners to apply for regulation.

The new Board must have at least five members, including one member of each profession (such as they are) regulated. One member must be an M.D. or D.O., although if no medical or osteopathic doctor is willing to serve the governor can appoint an advanced practice registered nurse (APRN) instead. Perhaps this indicates the level of enthusiasm for board service the legislature anticipates. The governor must also appoint a pharmacist, an APRN and a layperson, although no provision is made if none of them want to do this either.

The new law contains the typical boilerplate found in other naturopath licensing bills (discussed further below) although this one is unusually short on details and leaves it to the State Board of Integrative Health Care to sort out the specifics. The law does say that NDs cannot prescribe or administer drugs or ionizing radioactive substances or perform surgery. And even though the statute describes naturopathy as “a system of primary health care … for the prevention, diagnosis, and treatment of human health conditions, injury, and disease” a licensed naturopath “may not hold out to the public that the naturopath is a primary care provider.”

The law has two laudable provisions. First, naturopaths are prohibited from “the making of false or misleading statements about the licensee’s skill or the efficacy of any medicine, treatment, or remedy.” (Emphasis mine.) That last phrase is going to make it pretty quiet around the N.D. office. After all, if you can’t misrepresent the efficacy of, for example, homeopathic preparations or herbal supplements it’s going to be hard to come up with an explanation of exactly why you’re prescribing (or selling) them.

Second, another provision prohibits “the representation to a patient that a manifestly incurable condition, sickness, disease, or injury can be cured.” Too late for Hulda Clark, but at least the legislature had the good sense to take care that end on the bell curve of charlatanism.

Pending licensing legislation

Naturopathic licensing bills are now before the legislatures of Massachusetts (House Bill 2367, Senate Bill 1158), North Carolina (House Bill 847, Senate Bill 467) Illinois (House Bill 3350), Pennsylvania (House Bill 1717), and New York (Assembly Bills 1937 and 3057, Senate Bill 1803).

As with all naturopathic licensing legislation, these bills are based on three unproven notions: that the general public wants access to naturopaths, that naturopathic licensing protects the public from substandard health care practices, and that “educated” naturopaths are the answer to quality of care issues.

And as is true of other bills pending in 2011, both successful and not, these proposals to license naturopaths buy into the same false premise set forth in Massachusetts House Bill No. 02367:

Naturopathic health care [is] a system of health care practices for the prevention, diagnosis, evaluation and treatment of illnesses, injuries and conditions of the human body through the use of education, nutrition, natural medicines and therapies and other modalities which are designed to support, stimulate or supplement the human body’s own natural self-healing processes.

Yes, it’s those famous “self-healing processes,” which, if we can only hit them with the right plant, or animal part, or mineral, or electric current, or needle, or pressure, or thrust, or energy field, they will spring forth and do their job. They’re just being stubborn, you see, lurking there in the body, refusing to heal. Like little gods, they must be appeased with food and other amusements. And they like theirs natural.

Pennsylvania in particular wants to go after the body’s self-healing processes full bore. Its proposed licensing act would allow naturopaths to practice “behavioral medicine,” including cognitive therapy. As well, they could employ “naturopathic musculokeletal therapy” on, among other things, scar tissue and visceral organs, and “reposition … displaced body tissues and organs.” Then there’s electromagnetic energy, colon hydrotherapy, electrotherapy, magnetic therapy, low-level laser light, neural therapy, diathermy, dietary supplements and “bio-identical” hormones.

And what naturopathy licensing act would be complete without homeopathy, now with a new, improved statutory definition in Pennsylvania: “a system of employing substances of animal, vegetable or mineral origin which are given in microdosage in the prevention and treatment of disease.” “Microdosage”? How about “nonexistentdosage”?

One means of poking the body’s “self-healing processes” not available under any state’s proposed legislation is acupuncture. It is specifically prohibited except under one version of New York’s licensing bill, where it is not mentioned either as part of the permissible scope of practice or as a prohibition.

A Learner’s Permit to Practice Medicine?

One version of a New York Assembly licensing bill (A01937) and a Senate bill would prohibit the practice of naturopathy except under the supervision of a physician. (Assembly bill A03057 does not include this prohibition, and further allows “naturopathic childbirth.”)

Neither North Carolina’s Senate or House bill require actual physician supervision, but applicants for licensure must provide the North Carolina Naturopathic Doctors Licensing Board with a list of physicians from at least four specialty areas who have “agreed to work with … and accept referrals from the applicant.” The Senate bill would create an “Advisory Council” to “foster coordination and collaboration” between N.D.s, M.D.s and other health professionals “for the purpose of providing appropriate care for patients.” Naturopaths could not prescribe drugs in N.C.

In Pennsylvania, naturopaths would be regulated by the Board of Medicine. A “Naturopathic Formulary Committee” must include two physicians, a pharmacist, and someone with an advanced degree in pharmacology or pharmacognosy. Massachusetts establishes a naturopathic board which includes physicians and a pharmacologist. It does not give naturopaths prescribing privileges.

On the other hand, in Illinois, naturopaths would have their own board, which has no M.D. or D.O. physician members. However, both physicians and pharmacists must be on the “Naturopathic Formulary Council,” which would establish a formulary that can include prescription drugs.

The Illinois House licensing bill establishes a “Naturopathic Childbirth Attendance Advisory Committee” (which must include an M.D. obstetrician and a certified nurse midwife) to look into naturopathic education and training, then make recommendations regarding naturopathic childbirth attendance, which the Department of Financial and Professional Regulation must adopt as rules. The N.D. must pass the North American Registry of Midwives examination to practice “naturopathic childbirth attendance.”

All of these proposals indicate to me that the state legislatures don’t quite trust naturopaths. Naturopathy, as defined by naturopaths, is a free-standing health care philosophy (if you will) perfectly capable of operating without supervision from “mainstream” medicine. But the states aren’t buying it. While they are willing to consider licensing, it’s clear the state legislatures are not willing to unleash naturopaths on the public without some version of physician oversight. This is especially obvious regarding childbirth and prescription drugs. After all, for example, if one believes naturopaths are “real doctors” then why do they need to pass a midwifery exam to deliver babies?

This is an unfortunate half-baked approach. If the states don’t believe the education and training of naturopaths is up to par, then they shouldn’t license them at all. Instead naturopaths are given learner’s permits to practice medicine – they can be doctors, but only with adult supervision.

And now, for the good news

Naturopathic licensing bills failed in four states in 2011: Maryland, Virginia, Colorado, and Iowa. In Colorado it failed for the eighth time, largely due to the indefatigable Linda Rosa, RN, Larry Sarner and Mark Johnson, MD. In the past, the Colorado Medical Society has failed science-based medicine by supporting naturopathic licensing. This time around, according to Ms. Rosa, the Colorado Medical Society leadership stuck to their deal with the naturopaths to allow registration in exchange for naturopaths not using the term “physician” and limiting some of their scope of practice.

You can’t always get what you want…

But you can always go back and ask again, which is what’s happening in states already licensing naturopaths.

New laws in Washington and Arizona expand the scope of naturopathic practice. Arizona now allows IV administration of “nutrients.” The Arizona Naturopathic Medical Association requested “parenteral” administration authority but that word was changed to “intravenous” in committee.

In Washington, naturopaths will now be governed by their very own Board of Naturopathy, free of the meddling influence of M.D.s, D.O.s or pharmacists – the Board is composed of five N.D.s and two public members. In addition, naturopaths may now give orders to respiratory therapists and prescribe contraceptive drugs. A limitation on the use of “physical modalities” to those that are “non-invasive” was lifted.

Other bills failed to make it out of committee before the legislatures adjourned:

Alaska: would create a Naturopathic Medical Board for purpose of expanding allowed practices and procedures, including limited prescriptive authority.

Idaho: attempt to establish something called a “registered naturopathic practitioner,” which required no formal education if one had “practiced as a doctor of naturopathy” for 20 years.

Kansas: would expand the scope of naturopathic prescribing authority to include intramuscular, subcutaneous or intravenous administration of vitamins, minerals and homeopathic preparations, as well as prescription and administration of, among other things, whole gland thyroid. (If I may be permitted a comment: EEWWWW!)

Hawaii: would allow naturopaths to prescribe controlled substances.

New Hampshire and Oregon: would mandate insurance coverage of naturopathic services.

Still pending are bills in California to expand drug prescribing authority and in Hawaii to mandate insurance coverage for naturopathic services.

Hawaii law, very sensibly, requires the state auditor to submit a report assessing “both the social and financial effects of proposed mandated coverage.” In what I personally consider a new low in legislative drafting sleaziness, the Hawaii Senate’s concurrent resolution requesting the auditor’s study states:

WHEREAS, according to the American Cancer Society, naturopathy is ‘a complete alternative care system that uses a wide range of approaches such as nutrition, herbs, manipulation of the body, exercise, stress, and acupuncture … .’

Here’s a more, um, holistic view of the American Cancer Society’s statements on naturopathy for the state auditor’s consideration:

Available scientific evidence does not support claims that naturopathic medicine can cure cancer or any other disease, since virtually no studies on naturopathy as a whole have been published.

Available scientific evidence does not support claims that naturopathic medicine is effective for most health problems. Most of the claims of effectiveness are based on individual cases, medical records, and summaries of practitioners’ clinical experiences.

Excessive fasting, dietary restrictions, or use of enemas, which are sometimes components of naturopathic treatment, may be dangerous. Naturopathic treatment may involve taking unregulated herbs, some of which may have harmful effects.

As if that weren’t enough, the Hawaii Senate’s resolution adds:

WHEREAS, naturopathic medicine has become recognized as a therapy that is comparable in its effectiveness to more traditional medical and surgical practices for many types of illnesses…

Gosh, I looked and looked on PubMed and couldn’t find a single thing to support that statement. Maybe the state auditor’s research will turn up something.

By the way…

It would cost a whole lot of money – I don’t know how much, but a whole lot for sure – to draft and introduce licensing legislation and shepherd it through the legislative process in any one state. To do this in ten states in one year must cost an astronomical amount, especially in states the size of New York, Pennsylvania and Illinois. Who’s paying for this?

Conclusion

No person should be subjected to scientifically implausible diagnostic methods and treatments. States should be working to eliminate such practices, not giving out licenses to perpetuate them.

Passage of naturopathic licensing bills in the five states where legislation is pending would substantially increase the population subject to this conglomeration of pseudoscientific practices. But even one more licensing law in one state is one too many. Supporters of science-based medicine should actively oppose the “legislative alchemy” that is naturopathic licensing and, where licensing is already entrenched, oppose expansion of scope of practice and insurance mandates.

In fact, it is possible to eliminate existing licensing of naturopaths altogether, as Florida has done.

Notes

1. See, Bellamy J., Legislative Alchemy: the US state chiropractic practice acts, Focus on Complementary and Alternative Therapies (2010)15(3): 214–222.
2. For an excellent primer on naturopathy, see also, Atwood K., Naturopathy: A Critical Appraisal, Medscape, General Medicine. (2003);5(4). http://www.medscape.com/viewarticle/465994
3. Downey L, et al, Pediatric Vaccination and Vaccine-Preventable Disease Acquisition: Associations with Care by Complementary and Alternative Medicine Providers, Matern Child Health J (2010) 14: 922-930.
4. N.D. Cent. Code Ch. 43-58 (2011).

<!--<!--

The fundamental concept of science-based medicine (SBM) is that medical practice should be based upon the best available science. This may seem obvious, but there are many important details to its application, such as the relationship between clinical and basic science. Clinical claims require clinical evidence, but clinical evidence can be tricky and is often preliminary. It is therefore helpful (I would say essential) to view the clinical evidence in light of all of the rest of science.

A thorough basic and clinical science analysis of a medical claim can be summarized by the term “plausibility,” or “prior probability” if you want to put it into statistical terms. When we say a certain belief is plausible we mean it is consistent with what we know from the rest of science. In other words, because of the many weaknesses of clinical evidence, in order for a therapy to be generally accepted as part of SBM it should have a certain minimal supporting clinical evidence and overall scientific plausibility.

These can exist in different proportions – for example one therapy may be highly plausible (it would be shocking if it were not true) and have modest supporting clinical evidence, while another may have unknown plausibility but with solid clinical evidence of efficacy. But no therapy should have clinical evidence that suggests lack of efficacy, nor extreme implausibility (not just an unknown mechanism, but no possible mechanism).

The poster child for extreme scientific implausibility within medicine is, arguable, homeopathy. Its “law of similars” is little more than sympathetic magic, and its “law of infinitessimals” leads to concoctions diluted to the point that they have zero active ingredient and only the magical memory left behind. It is this reality which inspired a recent review to characterize homeopathy as “witchcraft.”

What about the clinical evidence? The clinical evidence, when taken as a whole, and even if we set aside the question of plausibility, shows that homeopathy does not work. Decades of research have failed to provide supporting evidence for any application of homeopathy. It has failed to reject the null hypothesis, to show efficacy, to allow for the recommendation of homeopathy for any indication, to differentiate homeopathy from a placebo – in other words, homeopathy does not work.

If we consider the SBM criteria above, we can summarize homeopathy by saying it has extreme implausibility and the clinical evidence shows lack of efficacy. It should not work, and it does not work. There is no legitimate controversy about this. The only think keeping homeopathy alive are delusional proponents and a public (including many regulators) who do not know what homeopathy truly is.

Proponents, however, are desperately trying to keep their pseudoscience alive by misrepresenting the evidence and the arguments of homeopathy critics. A recent example of this is a paper by Peter Fisher, the Clinical Director Royal London Hospital for Integrated Medicine, and a prominent homeopath. He is trying to coin the phrase “negative plausibility bias.” His argument, essentially, is that the evidence shows homeopathy works (at least as well as medical treatments that do not work, which is an odd argument), but there is a negative plausibility bias against homeopathy which motivates scientists to reject this evidence. Fisher is both wrong and irrelevant in this position.

Fisher is wrong in arguing that the clinical evidence supports the efficacy of homeopathy. He does this by cherry picking positive studies (which are part of the noise of any clinical research), a common strategy. Meanwhile, systematic reviews do not show supporting evidence for homeopathy. Worse for homeopathy, there is a clear pattern in the research. The better designed and controlled the study, the more negative the results – a clear pattern of lack of efficacy. Even reviews that desperately try to spin the results in a positive way in the end show there is no evidence to support the efficacy of homeopathy.

The main point of the article, however, is to dismiss the scientific assessment of homeopathy as a “bias.” It seems like it is news to Fisher that plausibility is not a bias – it’s science.

Interestingly, Fisher claims that the law of similars part of homeopathy is not even controversial – and then he makes the same, tired analogies to hormesis and paradoxical drug effects, which actually have no relevance to homeopathy. Homeopathy “ingredients” are chosen for magical reasons that have no relationship to actual biology or chemistry. Further, the high dilutions of homeopathic preparations render such analogies invalid. Fisher and other homeopaths are just fishing for any possible hand-waving justification for homeopathy, but they lend nothing to its plausibility because they fail to make a scientifically coherent argument.

Fisher then essentially argues that the clinical evidence shows homeopathy works (wrong) but is rejected because of the “negative plausibility bias.” There is a kernel of truth to his view in that, in the face of extreme scientific implausibility, even modestly positive clinical evidence is looked upon as insufficient and not definitive. We can look at it this way – what are the odds that a mountain of solid basic science is wrong vs some sloppy and tricky clinical research is wrong? It would take overwhelmingly rigorous and positive clinical evidence to call into question long established principles of basic science. Homeopathy does not come anywhere close – even if we take the distorted and incorrect view of the clinical evidence Fisher is pushing.

The article is essentially Fisher whining that the scientific community is not ignoring the extreme scientific implausibility of homeopathy.

Fisher also tries to make a tu quoque argument – recycling yet another old ploy of medical pseudoscientists. He says that the evidence for antibiotic use in upper respiratory tract infections (URTI) is no different than homeopathy but practitioners use antibiotics and not homeopathy. The evidence base for any other practice is irrelevant to homeopathy, but even that aside his argument is a curious one. I agree that systematic reviews fail to show efficacy for routine antibiotic use in URTI. Therefore – they should not be used. In fact there are efforts within mainstream medicine to reduce the use of antibiotics in URTI, and to eliminate their routine use.

The story with URTI is more complex, however, because some people do get bacterial interference with URTI and there may be a role for antibiotics in selected cases – the trick is in knowing how to select those cases. More research is legitimately needed to explore these issues.

The only consistent position, therefore, is to favor the elimination of routine antibiotic use in URTI, based upon current evidence, and also to favor the complete elimination of homeopathy as a practice. Meanwhile, it is reasonable to do more research into a possible limited role of antibiotics in selected cases (based partly on plausibility). It is also reasonable to favor the abandonment of any further research into homeopathy, based on its extreme scientific implausibility.

You can call it a “negative plausibility bias” or you can call it science, based upon your perspective.

<!--<!--

During the early days of the 2009 H1N1 influenza A pandemic, the popular herbal formula maxingshigan–yinqiaosan was used widely by TCM practitioners to reduce symptoms. (It’s hard to pronounce and spell, so I’ll refer to it as M-Y.) A new study was done to test whether M-Y worked and to compare it to the prescription drug oseltamivir. It showed that M-Y did not work for the purpose it was being used for: it did not reduce symptoms, although it did reduce the duration of one sign, fever, allowing researchers to claim they had proved that it works as well as oseltamivir.

“Oseltamivir Compared With the Chinese Traditional Therapy: Maxingshigan–Yinqiaosan in the Treatment of H1N1 Influenza” by Wang et al. was published in the Annals of Internal Medicine earlier this month. The study was done in China, which is notorious for only publishing positive studies. Even if it were an impeccable study, we would have to wonder if other studies with unfavorable results had been “file-drawered.” It’s not impeccable; it’s seriously peccable.

It was randomized, prospective, and controlled; but not placebo controlled, because they couldn’t figure out how to prepare an adequate placebo control. They considered that including a no treatment group compensated for not using a placebo control, and that objective temperature measurement could be expected to get around any bias. It might not: the nurses who took the temperatures were blinded to the study, but the patients were not. It’s possible that those who knew they were getting M-Y might have believed in it and their bias might have somehow subtly influenced data gathering so that M-Y appeared more equivalent to oseltamivir than it actually was.

There are other problems besides the lack of blinding.

Background

It’s always fun to read the introduction section of a CAM paper. It gives insight into the researchers’ beliefs and frequently includes footnote references to studies that don’t say what they seem to think they say. In their introduction, Wang et al. say

Traditional Chinese medicine has been used to treat seasonal influenza for thousands of years.

The article they reference to support that claim doesn’t support it. It is an opinion piece about “Chinese medicinal materials and their interface with Western medical concepts.” It’s not a historical study, and it doesn’t directly address influenza . Anyway, thousands of years ago TCM did not recognize influenza as a unique disease entity or have any way of diagnosing it accurately.  And TCM does not equate to M-Y.

Next they cite a meta-analysis that they say showed the effectiveness and safety of TCM, but it was not about flu or about M-Y. It was about studies of common cold patients with wind-cold syndrome. It concluded

TCM new drugs developed in recent years for preventing and treating common cold have better therapeutic effects than the old ones. They can accelerate the onset time of lowering body temperature and improve the symptoms of common cold without any significant adverse reactions. Because of lacking of placebo-controlled and blank-controlled studies, further high-quality trials are still needed.

The abstract is too garbled to understand, but it indicates that if there was any significant effect of “TCM” it was very small in magnitude. Saying that a study of TCM for colds shows that M-Y works for influenza is like saying that a study of Western medicine for pneumonia proves that penicillin works for bronchitis.

Design

the decision about whether to initiate antiviral therapy is individualized on the basis of the clinician’s judgment and on what is known about the benefits of therapy. Therefore, it was ethically possible for us to include a control group that received no intervention.

If individual decisions are ethically acceptable, how can it be ethical to decide that a whole random group of patients will be consigned to treatment or no-treatment groups?

The new study had over 400 subjects and few dropouts. Patients were admitted to the hospital and followed closely. Viral studies confirmed H1N1 influenza. There were 4 arms: M-Y, oseltamivir, M-Y plus oseltamivir, and a no treatment group. Endpoints were both objective (temperature and viral shedding) and subjective (reported symptoms).

Results

Time to resolution of fever was significantly shorter in all treatment groups than in no-treatment control group, and was comparable in the different treatment groups. There were no differences between groups on symptoms or viral shedding.  There was no difference in acetaminophen use between groups. Patients in the control group were more likely to be prescribed antibiotics, even though they acknowledge that physicians often respond inappropriately to persistent temperature elevations by administering antibiotics that are not called for in that situation.  If they knew that, why did they allow it to happen?

Complications like pneumonia were rare and not significantly different between groups.

Side effects were incomprehensibly rare: Two patients reported nausea and vomiting while taking M-Y and there were no side effects in the other groups. This is puzzling, since studies of oseltamivir have shown a 9-10% incidence of nausea and vomiting with the drug and 3-6% with placebo.

They interpreted their findings as showing that maxingshigan–yinqiaosan does not act as an antiviral, whereas the benefit of oseltamivir derives entirely from its antiviral activity. Their data do not justify that interpretation.

The Mixture

When herbs are mixed, I always wonder how they decided which ones to use. In this case, maxingshigan studies have shown immunomodulatory effects, but what about the other 11 ingredients?

M-Y is a mixture of 12 herbs. In this study the herbs were tested to rule out contamination with heavy metals, insecticides, and microbes. The need for such testing brings up a concern: when patients buy M-Y on the market, what are they getting?

The 12 ingredients, as far as I could determine from the information in the paper, correspond to ephedra, anemarrhena rhizome, artemisia (wormwood), gypsum, honeysuckle, skullcap, bitter apricot kernel, forsythia fruit, peppermint, fritillaria bulb, burdock, and licorice. Only about half of these are listed in the Natural Medicines Comprehensive Database. For most of these, flu is not listed as an indication (although allergies and respiratory infections are sometimes mentioned), and most say there is insufficient evidence to rate safety or to rate effectiveness for any indication. Some include warnings: ephedra is unsafe and is illegal in the US; apricot kernels are a source of cyanide. It is hard to imagine a rationale for combining these particular 12 ingredients for any purpose, much less for flu. Maybe I lack imagination.

An appendix that lists Chinese and English names for the ingredients includes this helpful explanation:

Chinese herbs are usually prescribed in formulas that contain “king” medicines, which provide the strongest therapeutic action; “minister” medicines, which assist the “king” medicine in its therapeutic actions; “assistant” medicines, which aid the “minister” medicine in treating a lesser aspect of the disease; and “ambassador” medicines that are intended to reduce the toxicity of the other medicines in the formula or guide the formula to the targeted organ or region of the body.

They offer no justification for which ingredient has which of these purposes or how they knew whether they actually work for those purposes. These terms are not scientifically meaningful and are unexpected in a journal like the Annals of Internal Medicine.

Conclusion

Most patients with influenza recover with no specific treatment; but oseltamivir is often used with the goals of faster recovery, reduced symptoms and fewer complications. It is also used to prevent influenza. But it is far from perfect. Studies have shown that it reduced the risk of pneumonia and of pneumonia, fever, and viral shedding. Its symptom-reducing effects are not very robust, and it can have some side effects. It would be nice if we had a safer, more effective remedy.

They concluded:

Maxingshigan–yinqiaosan can be used as an alternative treatment of H1N1 influenza A virus infection when oseltamivir is not available.

I can’t really argue with that, but why not try to make oseltamivir available? Why not try to insure the purity and safety of available preparations of M-Y? More importantly, why not try to figure out what each of those 12 herbs does, whether all 12 are essential for its effectiveness, and whether worrisome ingredients like ephedra and cyanide could be eliminated?

It is admirable that TCM practitioners are trying to study their remedies scientifically; but this study doesn’t convince me that M-Y offers any advantage over oseltamivir, or even that it is a reasonable substitute.

<!--<!--

Detroit is my hometown, and three and a half years ago, after nearly twenty years away wandering between residency, graduate school, fellowship, and my first academic job, I found myself back in Detroit minted as surgical faculty at Wayne State University and practicing and doing research at the Barbara Ann Karmanos Cancer Institute. One thing that I had forgotten about while I was away for so many years is just how intimately southeast Michigan interacts with Canada. This closeness is not surprising, given that Detroit and Windsor are separated by only about a half mile of Detroit River. Indeed, a there are a lot of Canadians who cross the border on a daily basis to work in the Detroit area, many of them in the medical center within which my cancer center is located. The reason I point this out is not to wax nostalgic for trips to Windsor or for the occasional trip to Stratford to see plays but to point out that Ontario is right next to us. What happens there is of concern to me because I know quite a few people who live there and because it can on occasion influence what goes on over here on the U.S. side of the border.

I recently learned that the College of Physicians and Surgeons of Ontario (CPSO) has been working on updating its policy on the use of nonconventional medical therapies. The wag in me can’t help but wonder why such a policy would need to say anything other than that, if it isn’t science- and evidence-based, the CPSO doesn’t support using it, but in a less sarcastic moment I realized that such a policy is probably not that bad an idea, as long as it doesn’t legitimize pseudoscience, which is, of course, the biggest pitfall to be avoided when writing such a policy. Not too long ago, the CPSO released its draft policy and has asked for public comments, with the deadline being September 1. I was happy to learn that I had not missed the deadline, because there is much to comment about regarding this policy, but it’s definitely true that time’s short. Unfortunately, I wasn’t so happy when I read the title of the draft policy, namely Non-Allopathic (Non-Conventional) Therapies in Medical Practice, with a subtitle of “Formerly named Complementary Medicine.” The full policy in PDF form can be found at this link.

“Allopathy” versus everything else?

Regular readers of SBM will probably notice one thing right away, even before clicking on either of the links and reading the draft policy. The problem is right there in the title and, in fact, I was floored when I first read the title. My jaw dropped, and dropped hard. Basically, I couldn’t believe that the CPSO had decided to use the term “allopathic” to describe science- and evidence-based medicine. True, that wasn’t the only problem, but it gave me a sinking feeling to see such a term right there in the title. So what’s the problem?

“Allopathic medicine” was a derogatory term originally coined by Samuel Hahnemann, the inventor of homeopathy to contrast homeopathy with the medicine of the time, namely that of 200 years ago. Hahnemann, as you may recall, believed in what he called the Law of Similars, which states that “like cures like,” or, to be more clear, that medicines that cause the same symptoms as a disease should be used to treat the disease. Doing this would stimulate the “vital force” and lead to resolution of the symptoms. Of course, this is nothing more than the principles of sympathetic magic transmuted (if you’ll excuse the term) into a different element, namely that of medicine; there has never been any convincing evidence—or even much in the way of evidence at all—that “like cures like” (or, using the Latin that Hahnemann favored, similia similibus curentur) is a general principle in biology or medicine. According to Hahnemann, “allopathy,” as opposed to homeopathy, is medicine that violated the law of similia similibus curentur and treats disease using remedies whose effects differ from those produced by that disease, the term meaning “other than the disease.” From its very origin, in fact, “allopathy” has been a derogatory term for medicine that is not homeopathy. Indeed, you can even find quotes to that effect documented in—of all places—the Wikipedia entry on allopathy. For instance, James Whorton points out in his book Nature Cures: The History of Alternative Medicine in America:

One form of verbal warfare used in retaliation by irregulars was the word “allopathy.” Coined two hundred years ago by Samuel Hahnemann, founder of homeopathy, it was taken from Greek roots meaning “other than the disease” and was intended, among other things, to indicate that regular doctors used methods that were unrelated to the disharmony produced by disease and thus were harmful to their patients. “Allopathy” and “allopathic” were liberally employed as pejoratives by all irregular physicians of the nineteenth century, and the terms were considered highly offensive by those at whom they were directed. The generally uncomplaining acceptance of [the term] “allopathic medicine” by today’s physicians is an indication of both a lack of awareness of the term’s historical use and the recent thawing of relations between irregulars and allopaths.

The other aspect of the term “allopathy” is that it was consciously used by practitioners of “unconventional” medicine to relegate “conventional” medicine to nothing more than another “competing” school of medicine. The term thus serves the simultaneous purpose of bringing “allopathic medicine” down to homeopathy’s level and elevating homeopathy to the level of conventional medicine. Far better, albeit still imperfect, characterizations could be:

Science-based medicine versus nonscientific medicine
Conventional medicine versus unconventional medicine
Medicine versus unproven medicine

Other possibilities come to mind. Of course, my preferred one (reality-based medicine versus magic) is probably a bit too stark. Be that as it may, I would contend that accepting the language of practitioners of unscientific medicine and using it in an official policy statement is not a good idea. Language has power and meaning. No one knows that better than promoters of “complementary and alternative medicine” (CAM) or “integrative medicine” (IM) or whatever it is that quacks decide to call it next. While the use of language in the CPSO draft is disturbing enough in and of itself, there are more substantive problems with the draft that need to be discussed.

Beyond “allopathic medicine”

The opening of the CPSO statement does not begin any more auspiciously than the title, after which the statement quickly devolves into meaningless platitudes that accept many of the false equivalencies promoted by CAM practitioners when arguing for pseudoscience. For example, check out how the draft opens:

In increasing numbers, patients are looking beyond allopathic medicine to nonallopathic therapies for answers to complex medical problems, strategies for improved wellness, or relief from acute medical symptoms. Patients may seek advice or treatment from a range of health care providers, including Ontario physicians.

The College supports patient choice in setting treatment goals and in making health care decisions, and has no intention or interest in depriving patients of non-allopathic therapies that are safe and effective. As a medical regulator, the College does, however, have a duty to protect the public from harm. Thus, the object of this policy is to prevent unsafe or ineffective non-allopathic therapies from being provided by physicians, and to prohibit unprofessional or unethical physician conduct in relation to these therapies.

Right from the beginning, all the buzzwords and false equivalencies are right there. There’s the appeal to popularity in the form of the unreferenced, unsupported statement that more patients are embracing non-science-based medicine. That’s rapidly followed by the platitude assuring us that the CPSO supports patient “choice,” which implies by contrast that those who might not be as open to “non-allopathic” medicine are somehow against “patient choice.” particularly given the line of how the CPSO has “no intention or interest” in “depriving” (note the word choice) of their woo. Of course, one wonders what these “non-allopathic” treatments are that are both safe and effective might be. After all, if they were both safe and effective they wouldn’t be “alternative.” I’m tempted to repeat that old trope that alternative medicine that is proven to be safe and effective ceases to be “alternative” and becomes simply “medicine.” Never mind. I just did. So did the CPSO:

The categorization of specific therapies as non-allopathic is fluid: as clinical evidence regarding efficacy is accumulated, certain non-allopathic therapies may gain broad acceptance and thus be accepted in allopathic medicine.

I’ve tried to think of an example of any such therapies that have made the leap from “non-allopathic” to “allopathic” medicine and am hard-pressed to do so. Be that as it may, just because this is an old trope doesn’t mean it isn’t true. Substituting the term “non-allopathic” medicine for term “alternative” medicine or CAM in this draft statement not-so-subtly equates what was once called CAM or “alternative medicine” with “allopathic medicine.” Again, language matters, and the CPSO knows it. Its choice of the the term “non-allopathic” was deliberate:

Different operative terms have been adopted that were deemed to be value-neutral: ‘Allopathic medicine’ refers to traditional or conventional medicine (as taught in medical schools) and ‘non-allopathic therapies’ refer to complementary or alternative medicine.

Notice also how the CPSO chooses to characterize patients looking for CAM as “looking beyond” allopathic medicine, which implies that CAM modalities are somehow ahead of or superior to “allopathy.” A more appropriate way to phrase this concept would be to say that patients are looking “outside of” science-based medicine or “elsewhere than” science-based medicine. But, no. Patients are “looking beyond” that tired, old, hidebound scientific medicine.

Imagine my relief that the College is committed to preventing unsafe or ineffective “non-allopathic” therapies from being provided by physicians. You know, ineffective like homeopathy.

Platitudes mixed with disturbing statements

If there’s one thing about this draft that impresses me about the CPSO draft policy is the sheer number of meaningless platitudes the CPSO packed into it. Mixed in with these platitudes are statements that range from disturbing to just plain puzzling. For instance, one puzzling aspect of the draft occurs where the CPSO points out that physicians should “refrain from exploitation” and abusing his power over patients and avoid conflicts of interest. No one, least of all I, would argue that physicians should exploit their patients or engage in activities that represent a blatant conflict of interest, but nowhere in the draft is this principle related to the use of “non-allopathic” medicine by patients or physicians. At least for the other principles the draft at least takes a stab at trying to relate them to patient autonomy, which, of course, the CPSO supports. The CPSO also expects physicians to:

1. Act in patients’ best interests, in accordance with fiduciary duties;
2. Respect patient autonomy with respect to health care goals, and treatment decisions;
3. Communicate effectively and openly with patients and others involved in the provision of health care;
4. Maintain patient trust through a commitment to altruism, compassion and service.

As opposed to, I suppose, advocating not acting in patients’ best interests, not respecting patient autonomy, not communicating effectively and openly, and not being committed to altruism, compassion, and service. I know, I know, I’m being a bit curmudgeonly, and I realize that these sorts of principles have to be repeated and emphasized, but it’s about the specifics of how physicians will adhere to such principles “where the rubber hits the road,” so to speak that such a policy should provide guidance. I would argue that it is a physician’s responsibility always to be honest with his patients and to pull no punches when it comes to giving his professional opinion. That is the very essence of acting in the patient’s best interest and communicating effectively and openly. What, then, am I to make of some of the statements in this draft that sound suspiciously like advocating pulling punches? For instance:

The College expects physicians to respect patients’ treatment goals and decisions, even those which physicians deem to be unfounded or unwise. In doing so, physicians should state their best professional opinion about the goal or decision, but must refrain from expressing non-clinical judgements.

I can’t help but wonder whether calling, for example, homeopathy “quackery” would be viewed as a “non-clinical” judgment by the CPSO. The language used smacks of the CAM-enabling sort of language that demands that we physicians above all remain “nonjudgmental.” Personally, I would counter that it is our professional responsibility to be judgmental when it comes to evaluating the evidence for a treatment. It is our duty to judge what treatments are safe and effective and which are not; that’s what our patients come to us for.

Here’s another problematic passage:

When providing non-allopathic therapies, physicians are expected to demonstrate the same commitment to clinical excellence and ethical practice, as they would when providing allopathic care.

The problem here is that providing “non-allopathic” care that is not evidence- and science-based (in other words, virtually all of it) is inherently unethical and represents anything but “clinical excellence.” This is a rather amusing conundrum to me. Consider this example. If a physician (and, make no mistake, there are a fair number of physicians who do this) offers homeopathy, which is nothing more than magical water supposedly imbued with mystical healing caused by the “memory of water” remembering whatever remedy that was in it before and forgetting, as Tim Minchin puts it, all the poo that’s been in it. How can any physician ethically offer homeopathy, for example, to a patient? Similar arguments construct themselves for other “non-allopathic” therapies, such as reiki (which is faith healing that substitutes Eastern mysticism for Christianity as its basis) or acupuncture, which postulates that sticking needles into “meridians” that have no detectable anatomic counterpart somehow “unblocks” the flow of vitalistic mystical life energy to healing effect. Yet, the CPSO goes on to state:

Physicians must always act within the limits of their knowledge, skill and judgement9 and never provide care that is beyond the scope of their clinical competence.

This expectation applies equally to treatments or therapies that the physician proposes and those that may be requested directly by patients. Where patients seek care that is beyond the physician’s clinical competence, physicians must clearly indicate that they are unable to provide the care. Physicians should consider whether a referral can be made to another physician or health care provider for care the physician is unable to provide directly.

While this is simply a restating of basic physician ethics when it comes to science-based medicine, I can’t help but wonder: Does this policy in the context of emphasizing patient autonomy and choice somehow obligate or imply an obligation for an Ontario physician to refer to a “non-allopathic” practitioner if that is what the patient wants? Shouldn’t there be a clear statement that a physician is not obligated to support the use of “non-allopathic” medicine if he believes it—and correctly so—to be quackery? The whole thing is a muddle, particularly given the statements elsewhere in the policy about how diagnosis and treatment should be based on the principles of “allopathic” medicine?

A brief policy statement

It’s obvious from the wishy-washy approach to the scientific basis of medicine, the waffle words when it comes to whether an “allopathic” physician should support “non-allopathic” therapies, and the apparently inadvertent use of language favored by quacks that there were far too many “alternative” practitioners involved in drafting this policy. Similarly, the comments are dominated by believers, although I must admit that one of them does point out the conflict inherent in this policy, as the CPSO tries to have it both ways:

“To act in accordance with the standards of allopathic medicine, physicians providing non-allopathic care must reach an allopathic diagnosis”

This doesn’t make sense! If I want non-allopathic care, then that includes a non-allopathic diagnosis. Allopathic labelling is only useful for determining which prescription to write and has no business in non-allopathic medicine!

This would be a bit of a problem in traditional Chinese medicine, where the diagnoses are based on “imbalances” in heat, moisture, etc., and some diagnoses come about by mapping organs to locations on the tongue. Similarly, in homeopathy, diagnoses are not necessarily based on physiology and treatments are based on homeopathic “provings.” Yes, this believer nailed the conundrum that the CPSO is trying to dance around.

To that end, let me propose a much briefer policy statement for the CPSO to consider in a few bullet points:

• Medicine should be science- and evidence-based. “Alternative” and “evidence-based,” “allopathic” and “non-allopathic,” “conventional” and “unconventional” are all false dichotomies. If a treatment is not evidence- and science-based, it is not medicine. Such a treatment becomes “medicine” only when it is demonstrated to work by science.
• Competent adults have every right to seek out non-science-based medicine if that is what they desire. However, informed consent mandates that physicians who encounter such patients provide an honest professional assessment of such treatments based on science.
• Physicians should always inquire about the use of non-science-based medicine when evaluating their patients, so that they can take into account possible interactions with medical treatments.
• Physicians are in no way obligated to refer patients to “alternative medical” practitioners. For many forms of “alternative medicine” doing so is unethical because such modalities are not science- or evidence-based.

I’m sure readers can come up with their own versions or suggest modifications and/or additions to the bullet points above.

In the meantime, there is still more than a week left before the September 1 deadline for supporters of science-based medicine to let the CPSO know the problems in its draft policy by e-mailing ComplementaryMedicine@cpso.on.ca or filling out CPSO’s online survey. It’s clear from the comments that are there now that more input from supporters of science-based medicine is needed.

Michael Kruse at Skeptic North has more.

<!--<!--