On June 16th the FDA issued a warning advising consumers not to use Zicam Nasal Gel or Nasal Swabs because of reports that it can damage the sense of smell, a condition called anosmia. This event highlights some problems with current regulations of health products.
There have been 130 cases reported to the FDA of decreased sense of smell following the use of one of these Zicam products – sometimes after a single use, sometimes after repeated use. All of these cases were reported by patients or their doctors; none were reported by the company, Matrixx Initiatives. According to reports, the FDA has asked Matrixx to turn over 800 consumer complaints regarding to Zicam. There is a 2007 law that requires company to report such complaints to the FDA, although the FDA has not said whether Matrixx violated this law.
Anosmia is a serious medical condition. The senses of smell is one of those things we take for granted until it is gone. People who lack a sense of smell cannot tell if milk has gone sour or if their food is bad. They cannot smell smoke to warn of a fire, nor can they smell a gas leak. The FDA fears that some of the cases of anosmia associated with Zicam use may be permanent.
In the three prior posts of this series I tried to analyze some of the defects in the randomized clinical rials (RCTs) of homeopathic remedies for childhood diarrhea. The first entry showed that the first two RCTs’ (done in Nicaragua) methods could not produce a meaningful result because of the way the RCTs were set up (methods.) The second entry showed that the results obtained in the first two trials were meaningless clinically even if assumed to have resulted from more legitimate methods. The same applied to the third trial in Nepal, analyzed in the third entry.
This entry will suggest that the authors’ fourth paper (Jacobs J, Jonas WB, Jimenez-Perez M, Crothers D. Homeopathy for childhood diarrhea: combined results and metaanalysis from three randomized, controlled clinical trials. Pediat Inf Dis J, 2005;22:229-234.)- a meta-analysis (MA) of the data from the three RCTs resulted in conclusions equally as meaningless as those of the three trials.
The MA authors – several of the same workers from the three RCTs – begin by agreeing that the data from the RCTs, taken individually, were of borderline significance:
In our previous three studies, we evaluated the use of individualized homeopathic treatment of childhood diarrhea … The results of the two larger studies (n = 81, n = 116) were just at or near level of statistical significance. Because all three studies followed the same basic study design , […] we analyzed the combined data from these three studies to obtain greater statistical power. In addition we conducted a meta-analysis of effect-size difference […] to look for consistency of effects.
MAs and systematic reviews (SRs) are the two consensus methods for summarizing data from multiple individual studies. The inclusion and search methods of RCTs for SRs and MAs are similar, but the objectives of the two are a bit different, as are the forms of the reports. In SRs, the results are summarized in more in narrative form, whereas in MAs the data are treated mathematically and the results are defined in statistical terms. Thus authors of SRs are freer to speculate on the degree of confidence that a method is effective based on what is shown by the numbers of positive and negative RCTs collected. Authors of MAs usually limit their comments to what the mathematical formulation of the summarized data show.
It had once been suggested in the comments section of the blog that homeopathy is useful in the treatment of diseases that are not self limited. Homeopathy is effective therapy for diseases that do not get better on their own, that homeopathy has a real effect on real diseases.
One example given was for the treatment of sepsis.
“Frass M, Linkesch, M, Banjya, S, et al. Adjunctive homeopathic treatment in patients with severe sepsis: a randomized, double-blind, placebo-controlled trial in an intensive care unit. Homeopathy 2005:94;75–80. At a University of Vienna hospital, 70 patients with severe sepsis were enrolled in a randomized double-blind, placebo-controlled clinical trial, measuring survival rates at 30 days and at 180 days. Those patients given a homeopathic medicine were prescribed it in the 200C potency only (in 12 hour intervals during their hospital stay). The survival rate at day 30 was 81.8% for homeopathic patients and 67.7% for those given a placebo. At day 180, 75.8% of homeopathic patients survived and only 50.0% of the placebo patients survived (p=0.043). One patient was saved for every four who were treated.”
I am, as I have mentioned before, but I mention again for those who might be new to the blog, an Infectious Disease physician. My job is to diagnosis and treat infectious diseases and sepsis is up there at the top of the list of diseases I take of. Sepsis butters my bread, and I consider myself knowledgeable about sepsis.
The previous post of this series analyzed the results of the 1994 Pediatrics paper purporting to show a statistically significant effect of homeopathic preparations on acute childhood diarrhea in a population in Nicaragua. That clinical trial followed a pilot study that also had shown a small but statistically significant effect of homeopathic remedies.
A moment here for explanation as to why I am going through these old studies. Reports like the four or five in this series made headlines. They are also so well cloaked in manipulated data and overdrawn conclusions that press and even academicians accept their conclusions – and even overdraw more. This is still going on.
Over the past thirty years some of us informally and gradually developed semi-systematic ways of analyzing these increasingly scientific-appearing claims of sectarians (sCAMmers.) Errors, inconsistencies and falsifications we recognize now were not so obvious decades ago. SCAMmers developed imaginatively new methods as their fields progressed. We in the science-based or knowledge based medicine field have been trailing along, detecting their tricks and twists as they developed, and like street sweepers behind horses, picking up their excrement (metaphor to force attention.) Yesterday’s lucid post on the latest acupuncture study by Steve Novella exemplifies this expertise (no offense intended.)
Perhaps you have discovered for yourself that I am always the last to write a post on a ‘hot’ topic. I am definitely the slowest writer (and thinker?) on this blog, starting each post at least a week before it is up. So the faster writers weigh in first and I am left with clean up.
As I finish writing on Thursday, there have been 892 cases of H1N1 aka Swine flu and 2 deaths in the US. Looks like the world has avoided a disastrous pandemic like the 1919 flu that killed off 2 to 5% of the world. For now. Maybe. I hope.
However, the flood of nonsense about the flu far exceeds the infection rates from H1N1. This entry will be the limited by necessity. The quantity of quackery (9) far exceeds my ability to type. I thought that influenza virus replicated and spread fast. It pales next to the flu woo.
Having grown up on a dairy farm, I am one of the least likely people to object to the deification of yogurt. However, as a critical thinker, I cannot help but resist the idea (promoted by some health sites) that probiotics are a reasonable alternative to chemotherapy in the treatment of colon cancer. And there are many other equally unhelpful claims being made all the time. Fish oil for ALS anyone?
What amazes me about the “cherry yoga” camp (as my friend Bob Stern likes to call it), is that they aggressively market CAM as “harmless” and “natural.” They point to the warning labels and informed consents associated with science-based medicines as evidence that the alternative must be safer. In reality, many alternative practices are less effective, and can carry serious risks (usually undisclosed to the patient). For your interest, I’ve gathered some examples of risks associated with common alternative practices that have been described by the CDC and in the medical literature:
…but an actual pro-science post at The Huffington Post in which the blogger, Jacob Dickerman, actually correctly describes why homeopathy is quackery! For instance:
Homeopaths will tell us that water has a memory. That it vibrates in a certain way and thus knows exactly what the homeopath put into it. The thing is, if Hahnemann is somehow right about homeopathy, then it doesn’t only fly in the face of all those sciences I listed above (physiology, physics, chemistry, germ theory, hydro-dynamics), it flies in the face of public safety. Because the Florine in our water will have less of an effect than the 65-million year old dinosaur feces that have been naturally distilled for millennia. They say that it has no side effects, and they’re right. What they don’t say is that it doesn’t have any primary effects either.
I still can’t believe I’m reading HuffPo after my prolonged screed yesterday about all the psuedoscience that’s appeared in Arianna Huffington’s little project since its inception in 2005. Best to head on over there before Patricia Fitzgerald, the homeopath who’s the new “Wellness Editor” at HuffPo finds out.
I realize that our fearless leader Steve Novella has already written about this topic twice. He has, as usual, done a bang-up job of describing how Arianna Huffington’s political news blog has become a haven for quackery, even going so far as to entitle his followup post The Huffington Post’s War on Science. And he’s absolutely right. The Huffington Post has waged a war on science, at least a war on science-based medicine, ever since its inception, a mere two weeks after which it was first noticed that anti-vaccine lunacy ruled the roost there. Because I’ve had experience with this topic since 2005, I thought I’d try to put some perspective on the issue, in order to show you just how pervasive pseudoscience has been (and for how long) at the blog whose name is often abbreviated as “HuffPo.”
This is the second installment analysis of a three (and now 4) part series of articles on effects of homeopathy on childhood diarrhea. This second installment elaborates on our findings on data from the second clinical trial in Nicaragua. (1)
I should first explain the title. In order for homeopathy to operate as a base or operating system for medicine “for the 21st century,” the entire system of measurement and of course all physical laws would have to be changed. In analogous political terms, it would be similar to – but more massive a change than – changing a nation from a democracy to a completely different system such as a theocracy with completely different laws and behavior expectations. So…well, it was the best I could think up at the time.
Last time I recounted how the Jacobs ll trial setup was incoherent and unable to produce results that could prove efficacy – unless the differences between treatment and controls were quite large, greater than just barely significant. Most patients were treated differently from others, with multiple preparations (that were in reality the same: pill filler) at differing times during the illness, with each preparation selected according to symptoms that likely varied by the hour, and influenced by memory, well known to be faulty in medical studies.
In fact, given the lack of homogeneity in the trial diagnoses and treatments, outcomes should not have made sense at all. Now I must admit that the thought did not occur to us at the time we undertook the review, nor during the review. If it had, our job would have been easier and the paper shorter.
Recent comments on homeopathy again resulted in references to the 1994 Pediatrics paper by Jacobs et al on use of homeopathic remedies for childhood diarrhrea. The authors of that paper concluded from their blinded study that homeopathic remedies, tailored to the individual infants and children, were effective in reducing the number of diarrhea stools and thus in shortening the illness. The paper has been widely referenced and reported to have proved homeopathy efficacy, and the critiques have been argued by homeopaths as irrelevant, as has been done by Mr. Ullman.
In this short series I want to recount my experience with the report, its predecessor, and its two major sequellae, as well as its effect on systematic reviews of homeopathy. I will begin with a description of the first two studies, concentrating on their methods. Then I will discuss the results of the 1994 Pediatrics report and the authors’ interpretation of the results. Then (I hope last) I will discuss the third paper which the authors claimed supported findings of the first two and the meta-analysis which combined data from all three. If you are imagining why this series interests me, and imagining the worst, you are probably right. The sequence will help to reveal how some of the information in “holistic” and “alternative” systems become published, and despite critiques and disproofs through a sort of systematic deconstructions, still develop wheels of their own and enter the fund of general knowledge seemingly forever. Or, at least for several decades, until a social belief switch is finally turned off.