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Homeopathy in the ICU?

ResearchBlogging.orgEditor’s note: It’s still a holiday weekend in the United States. I had considered simply taking the day off altogether, particularly since I’m busily working on my talk for TAM8–which (holy crap!) is in a mere three days–but then I figured today’s a good time to resurrect a “classic” (if you will) post that I wrote a few years ago, dust it off, and post it. I decided to do this mainly because I had been planning on bringing this post to SBM at some point right from the very beginning of SBM.

Regular readers of this blog are probably familiar with a certain homeopath named Dana Ullman. So persistent is he in his pseudoscientific arguments for the magic that is homeopathy that fellow SBM blogger Kimball Atwood once postulated a humorous law he dubbed the Dull-Man Law:

In any discussion involving science or medicine, being Dana Ullman loses you the argument immediately…and gets you laughed out of the room.

Kimball then pointed to a number of studies that Ullman likes to cite ad nauseam that supposedly “prove” the efficacy of homeopathy. One study Kimball didn’t mention, however, is a favorite of Ullman’s, one he likes to trot out time and time again. Specifically, it’s a study of homeopathy in the ICU that was published, in all places, in Chest, a respectable journal that, as you might expect, is dedicated to research on diseases of the chest, such as chronic obstructive pulmonary disease (COPD), cardiac disease, and basically any disease that manifests its pathology in the chest, although it primarily deals with critical care. I first learned of this study way back in 2007 from Dr. R. W., who at the time commented quite aptly that the article impressed him with just how far into the medical mainstream woo has penetrated, while retired doc also expressed his dismay.

Although I do feel a bit guilty not providing you with more original peerless prose pontificating on medical pseudoscience that you know and (hopefully) love, this article is constantly trotted out by homeopaths, even five years later, and that makes it worth updating an older post from another source. So here’s the abstract:

Influence of Potassium Dichromate on Tracheal Secretions in Critically Ill Patients.

Michael Frass, MD; Christoph Dielacher, RN; Manfred Linkesch, MD; Christian Endler, PhD; Ilse Muchitsch, PhD; Ernst Schuster, PhD and Alan Kaye, MD. Chest. 2005;127:936-941.

* From the Ludwig Boltzmann Institute for Homeopathy (Drs. Frass, Endler, and Muchitsch), Vienna, Austria; II Department of Internal Medicine (Mr. Dielacher and Dr. Linkesch); Department of Medical Computer Sciences (Dr. Schuster), University of Vienna, Vienna, Austria; and Department of Anesthesiology (Dr. Kaye), Texas Tech University Lubbock, TX.

Background: Stringy, tenacious tracheal secretions may prevent extubation in patients weaned from the respirator. This prospective, randomized, double-blind, placebo-controlled study with parallel assignment was performed to assess the influence of sublingually administered potassium dichromate C30 on the amount of tenacious, stringy tracheal secretions in critically ill patients with a history of tobacco use and COPD.

Methods: In this study, 50 patients breathing spontaneously with continuous positive airway pressure were receiving either potassium dichromate C30 globules (group 1) [Deutsche Homöopathie-Union, Pharmaceutical Company; Karlsruhe, Germany] or placebo (group 2). Five globules were administered twice daily at intervals of 12 h. The amount of tracheal secretions on day 2 after the start of the study as well as the time for successful extubation and length of stay in the ICU were recorded.

Results: The amount of tracheal secretions was reduced significantly in group 1 (p < 0.0001). Extubation could be performed significantly earlier in group 1 (p < 0.0001). Similarly, length of stay was significantly shorter in group 1 (4.20 ± 1.61 days vs 7.68 ± 3.60 days, p < 0.0001 [mean ± SD]).

Conclusion: These data suggest that potentized (diluted and vigorously shaken) potassium dichromate may help to decrease the amount of stringy tracheal secretions in COPD patients.

Holy homeopathy, Batman! Does this study mean that homeopathy actually works for critically ill patients in the ICU? Not so fast there, Robin. Let’s take a look.

First off, the title is interesting. Note how the word “homeopathy” or “homeopathic” does not appear. In fact, no derivative of the word “homeopathy” appears anywhere in the abstract. True, the Ludwig Boltzmann Institute for Homeopathy is mentioned in the institutional affiliations, but that would be easily missed by someone perusing the abstract. It’s almost as though the writers were trying to get this in under the radar. After all, most doctors don’t know much about homeopathy, which means that they don’t know much about what a “30C” dilution is or that such a dilution dilutes a substance to the point where there almost certainly isn’t a single molecule left.

First a word about the methods: Apparently in homeopathy lore, potassium dichromate is useful for treating thick respiratory secretions. On what basis, I don’t know. From where I come from, potassium dichromate is a nasty chemical; it’s a powerful oxidizing agent. Indeed, it’s sometimes used to clean laboratory glassware, although I never used it for that. It’s also used in photography and screen printing. It’s pretty toxic stuff and can cause a nasty dermatitis. Given all that, it’s a good thing that this stuff was diluted to nonexistence before being administered to patients sublingually (under the tongue)! If it weren’t, it could have caused some damage.

This all makes me wonder how this study ever got past the Institutional Review Board (IRB). After all, if there’s active ingredient left over, then the study would be proposing to give a toxic substance to patients on ventilators in an ICU. If the investigators made it very clear to the IRB that the dilution would be such that there would be no potassium dichromate left, then the IRB should have asked about the ethics of giving both experimental groups what is, in essence, a placebo. More disturbing is that the investigators stopped the administration of β-agonist bronchodilators to these patients before they were started on placebo or treatment, in order “to avoid any potential influence and/or interaction.” Again, if there is potassium dichromate in the homeopathic remedy, then why did the IRB allow the investigators to administer it in the first place with no supporting evidence, either in clinical or animal models, that it might have an effect? If there is no potassium dichromate in the homeopathic remedy, then stopping effective medications in both study groups strikes me as unethical. In fact, the investigators essentially admit that it is diluted to nothing:

In homeopathic concentrations, potassium dichromate acts primarily by its mucolytic properties. In this study, we used a preparation of C30, which is equivalent to a potentiation of 30 dilutions, in which each of the 30 dilution steps is followed by subsequent vigorous succussions. Therefore, the above-described toxic effects were eliminated. In addition, the original orange-red color disappeared during the preparation. Onset of action may vary from patient to patient but is generally observed within 24 to 48 h.

What “above described toxic effects,” you ask? None, really. The investigators didn’t describe any potential toxic effects from potassium dichromate until the discussion section. Apparently, the reviewers didn’t read this study too carefully (which is, of course, one possible explanation for such woo making it into a journal with an impact factor of 4.008). Be that as it may, let’s look at the patient characteristics, shall we?

First, there were only 25 patients in each group, which is a pretty small number for anything other than a pilot study. You have to remember that, when studies are small, spurious results are more likely to occur. At first glance, the patient characteristics in this table appear pretty well balanced. At first glance. Actually, this is a good example of when statistical nonsignificance doesn’t necessarily mean clinically nonsignificant. For one thing, the stage of COPD in the control group was higher than that of the treatment group (1.20 ± 0.5 versus 1.08 ± 0.4, p=0.178). This seems very odd, because both groups are listed as having mild COPD by this criteria, given that the COPD stages run from 0 to 3, with 0 being normal lung function and 1 being the least severe. If the average COPD stage for each group was close to 1, then why did the patients have such difficulty coming off the ventilator? Something’s odd there, since the mean FEV1 (forced expiratory volume in 1 second) was 54.0 ± 5.3% in the potassium dichromate group and 52.4 ± 5.5% in the control group, both of which are very close to the range of stage 2 COPD (FEV1 between 35% and 49%). In other words, it would seem that most of the patients were bad stage 1 patients.

A more interesting difference, however, and potentially more likely to influence the results of the study comes when you look at the number of patients who were on home oxygen before being hospitalized and developing respiratory failure. In the control group, 9/25 patients were on chronic home oxygen, whereas in the potassium dichromate group, only 5/25 were on home oxygen. Leaving aside that both numbers seem very high for two groups whose COPD scores are 1.2 or below given that it’s usually patients with stage 3 COPD who require home oxygen, it is clear that the control group had nearly twice the number of patients who were on home oxygen before admission. This seems inconsistent with a small difference in the COPD score, and the low COPD scores seem inconsistent with such severe exacerbations. After all, the definition of stage 1 COPD is:

Often minimal shortness of breath with or without cough and/or sputum. Usually goes unrecognized that lung function is abnormal.

Essentially no patients with stage 1 COPD need home oxygen. Ditto stage 2 COPD, which is defined:

Often moderate or severe shortness of breath on exertion, with or without cough, sputum or dyspnea. Often the first stage at which medical attention is sought due to chronic respiratory symptoms or an exacerbation

By the measurements listed, the average patient in both groups had at worst slightly worse than stage 1 COPD, which makes it odd indeed that 36% and 20% of the control and potassium dichromate groups, respectively, were on home oxygen. Let’s just put it this way. Needing home oxygen is a good marker for one of two things: either more severe COPD or other concurrent lung conditions. Those four extra patients on home oxygen could potentially account for the longer time to extubation and longer length of stay in the hospital in the control group. We can’t tell if they do or not because the data isn’t presented in such a way to allow us to do so. It’s possible that the differences in patients on oxygen before admission made a difference. It’s also possible that this is just a spurious result from a relatively small study. Or, it’s possible that it might be correct and there might really be an effect, but this latter scenario is unlikely given the flaws in the study and the fact that no homeopath has yet explained a mechanism by which something like homeopathic potassium dichromate might do a single thing to eliminate secretions–or anything else, for that matter.

The bottom line is that, contrary to Dana Ullman’s representation of this study as slam-dunk evidence of the efficacy of homeopathy, it’s nothing more than a very questionable study in which it is unclear whether the treatment and control groups were truly comparable. The homeopaths’ conclusion would be hilarious were it not so sad that such woo has found its way into otherwise reputable journals:

The present study suggests that potassium dichromate C30 may be able to minimize the amount of tracheal secretions and therefore to allow earlier extubation when compared to placebo. Since the potentiation (dilution and vigorously shaking) of the study drug beyond the Avogadro number imposes no interaction with the patient’s metabolism, and due to the low cost of the drug, its use in the ICU may be beneficial, minimizing morbidity and mortality. Studies give some insight into the potential way of action of homeopathically prepared drugs. Cluster-cluster aggregation phenomena in aqueous solutions of fullerene-cyclodextrin conjugates, β-cyclodextrin, sodium chloride, sodium guanosine monophosphate, and a DNA oligonucleotide revealed that there are larger aggregates existent in dilute aqueous solutions than in more concentrated solutions.20 In another study, ultra-high dilutions of lithium chloride and sodium chloride (10-30 g cm-3) have been irradiated by x-rays and gamma-rays at 77 K, then progressively rewarmed to room temperature. During that phase, their thermoluminescence has been studied and it was found that, despite their dilution beyond the Avogadro number, the emitted light was specific of the original salts dissolved initially.

This is the first scientific study of the effect of potassium dichromate on tracheal secretions. While the mechanism of potentized (diluted and vigorously shaken) drugs still remains subject to research, several articles describe its clinical usefulness. The effect may be best explained by cybernetics, which means that the information of the homeopathic drug acts consensually on the regulator. Thereby, the body regains its original property to regulate physical parameters.

First off, it’s nice to see that the investigators essentially admit that diluting above Avogadro’s number eliminates any trace of the compound. It is, however, unclear why they brought up ultrahigh dilution solutions irradiated at 77 Kelvin (or -196° C) and then rewarmed. First off, 10 to 30 molecules per cc is an incredibly concentrated solution in homeopathic terms. Second, homeopaths don’t cool their solutions down to the temperature of liquid nitrogen, irradiate them, and then slowly rewarm them, making me doubt very much the relevance of the experiment to anything that homeopaths do. But the part about cybernetics cracks me up. That one was clearly pulled out of someone’s hat (or perhaps out of their nether regions); yet it got by the reviewer.

As much fun as I have deconstructing such studies, hoping in vain for a good study but inevitably being disappointed, it is still disconcerting to see this sort of study published in Chest. More disturbing still is that an IRB allowed such a study of a useless medication on intubated ICU patients with COPD. It just goes to show that peer review is not perfect. It may remain the best bulwark against pseudoscience, but it’s only as good as the reviewers, and it’s not a foolproof guarantee against pseudoscience. As you can see from this study, it’s making its way into even the ICU, which is one place where evidence-based medicine should rule supreme and in which there should be no place for woo or quackery. What I fear is that, as more and more pseudoscience and non-evidence-based woo invades medical school, the dividing line between evidence-based medicine and woo will blur even more, and, as the older generations of physicians retire, the newer generation, who has been exposed to woo in medical school, will be less willing or able to call a duck a duck when they see it. Quack quack.

REFERENCE:

Frass, M. (2005). Influence of Potassium Dichromate on Tracheal Secretions in Critically Ill Patients Chest, 127 (3), 936-941 DOI: 10.1378/chest.127.3.936

Posted in: Clinical Trials, Homeopathy

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