One of the strengths of modern medical education is its emphasis on basic science.  Conversely, the basic weakness of so-called alternative medicine is its profound ignorance of science and its reliance on magical thinking.  Nowhere is this more apparent than in the attempts of altmed cults to conduct and publish research.  From “quantum water memory” to “almost as good as placebo”, the altmed literature is filled with basic failures in the proper formulation and testing of hypotheses.

One of the finest examples of these failures was just published in the journal Homeopathy.  Leaving aside for the moment the absurdity of a journal devoted to magic, let’s see what they did here.

Leptospirosis, a systemic disease caused by bacteria of the genus Leptospira, is probably the most common zoonotic (spread by non-human animals) disease on the planet.  It can cause anything from a mild flu-like illness to liver failure and death.  It is spread in water contaminated by urine from infected animals.  An outbreak occurred during my internship year among triathletes swimming in a lake in Illinois, but occupational exposures are more common.  There are no widely-available vaccines for disease prevention.

Given the common and sometimes serious nature of the disease, especially in developing countries, there is a need for effective prevention of leptospirosis.  One proposed solution, published this month in Homeopathy, is “Large-scale application of highly-diluted bacteria for Leptospirosis epidemic control.”

Methods

The authors conducted what they called an “epidemiologic cohort study”.  For the study, the designated a large area of eastern Cuba the “test” population (”intervention region (IR)”), and the rest of Cuba the “control” population.  These were assumed to be distinct geographic regions.

In the intervention region, local outbreaks were treated with vaccination and antibiotic prophylaxis which, according to the study, reached about 3% of the population, but they do not indicate whether this is 3% if the total population or a targeted, at-risk population.  The entire population of the intervention region was also targeted to receive a homeopathic  (i.e., inert*) preparation especially designed and “potentised” (i.e., shaken up) to prevent leptospirosis, as per homeopathic beliefs.

The authors state that the study complied with ethics requirements of the authoritarian regime who runs the country and presumably profits from the manufacture of the product being tested.

Data

The authors report that the control region had fewer natural disasters (and presumably were at lower risk for lepto) than the intervention region.  During one such emergency in the IR, the potion was widely used.  A drop in reports of the disease were noted afterward.

The statistical analysis section of the paper is quite long, but fails to address fundamental problems.  There was, in effect, no control group.  There was an opportunity to apply this alleged therapy on one group and placebo (chuckle) on another and compare rates of disease in each group.  This wasn’t done.  The entire population in question was treated, and rates of disease recorded.  The authors note that leptospirosis is occurs in cycles, and there is no reason to think that the drop in disease seen after the application of homeoprophylaxis is due to the intervention rather than to the natural course of the endemic.  Given that the intervention is supposed to be prophylactic rather than therapeutic, the authors’ conclusions are even more suspect.  Finally, the did end up comparing rates in the intervention region and the rest of the country, but these regions were defined as being geographically distinct, with different geography and differing rates of natural disaster.

This study has nothing to do with natural disasters.  Blame for the disaster here rests completely with the authors.  They conducted a study of questionable ethics and questionable methodology, and came up with questionable conclusions.  Most important, however, was the lack of a plausible hypothesis from the start.  There is no reason to think that ultra-diluted potions containing nary a molecule of “medicine” should affect anything.  Given this lack of plausibility, statistically significant findings should be examined with suspicion, and other explanations for any such findings should be sought aggressively.  The authors do not discuss possible alternative explanations, exacerbating the travesty that is their work.

References

Bracho, G., Varela, E., Fernández, R., Ordaz, B., Marzoa, N., Menéndez, J., García, L., Gilling, E., Leyva, R., & Rufín, R. (2010). Large-scale application of highly-diluted bacteria for Leptospirosis epidemic control Homeopathy, 99 (3), 156-166 DOI: 10.1016/j.homp.2010.05.009
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*From the paper:

From the mother tinctures, 1/100 serial dilutions wereprepared using homeopathic pharmaco-technical methods(Korvsakovian dilutions). Between each dilution step, thesolution was succussed 100 times using an automatic dynamizerup to 200C (200 1:100 dilutions) and 10 MC(104 1:100 dilutions).