Nov 15 2010
Over the weekend, my wife and I happened to be in the pharmacy section of our local Target store. We happened to be looking for one of our favorite cold remedies, because both of us have been suffering from rather annoying colds, which have plagued both of us for the last week or two. As we perused the Cold and Flu section of the pharmacy, we were struck at how much shelf space was taken up by Airborne (which was “invented by a schoolteacher“). Nearly three years ago Airborne had to settle a case brought against it alleging false advertising to the tune of $23 million. Despite that, Airborne is still being sold, and there are even a whole bunch of knock-off products copying it. Then, as we continued to look for our favored cold remedy, we noted that, sitting right next to the extensive shelf space devoted to the various flavors and types of Airborne supplements, I saw Boiron’s homeopathic remedy for colds containing oscillococcinum, which is derived from duck liver and heart and diluted to 200C (a 10400-fold dilution).
Yes, I was a bit depressed after that. Now I know what my skeptical friends in the U.K. go through every time they walk into a Boots pharmacy.
Still, even though homeopathy is not as popular in the U.S. as it is in the U.K. and the rest of Europe, it’s obviously making some inroads if it’s being sold in Target. Steve Novella made a point at a panel at TAM8 in July to point out that it’s also being sold in Walmart, but since I rarely, if ever, shop at Walmart, I hadn’t noticed, although I had noticed various dubious concoctions being sold at Walgreens and CVS, two large pharmacy chains here in the U.S. Its relative popularity in different parts of the world aside, ever since I learned what homeopathy is and what its precepts are, I’ve always been fascinated how it can possibly be taken seriously. After all, a 200C homeopathic dilution is approximately 10377-fold more of a dilution than Avagadro’s number, meaning that it’s incredibly unlikely that such a remedy has even a single molecule of active ingredient in it. Homeopathy is water, nothing more, but that makes it the perfect form of quackery to examine when looking for reasons why people still believe it works. I’ve pointed this out, and Kimball Atwood has repeatedly pointed this out, arguing that homeopathy is the best “complementary and alternative medicine” modality to show the deficiencies in randomized clinical trials (RCTs) because, except in the case of adulterated remedies (which are all too common) or low dilution remedies less than approximately 12C (where there might actually be an incredibly tiny amount of active ingredient left), homeopathy is nothing more than water and sugar.
With these thoughts running through my head, not long after I got home, I noted an e-mail from a reader, who had forwarded me a link about homeopathy. My first thought was: Homeopathy? Not again. However, every so often I find it of value to examine the very best arguments that homeopathy apologists can put forth for their magic water and (hopefully) thereby understand a bit more how people can be persuaded that a system of “medicine” so unbelievably implausible from a basic science point of view that it is as close to being impossible as we can imagine in science can be so attractive to so many people. Also, it’s always fun to take on Dana Ullman particularly after having kept it rather serious over my last few turns here on SBM. I realize that some will criticize me for “slumming” here, but throw me a bone every once in a while. I have to have some fun every now and then. In any case, on Friday, everybody’s favorite clueless homeopathic apologist posted an article on–where else?–that wretched hive of scum and quackery, The Huffington Post, entitling it Exploring the Research on Homeopathic Treatment for Fibromyalgia. It is, as we like to say, a “target-rich” environment.
FIBROMYALGIA: A WOO MAGNET
Ullman likes to try to impress his readers with a boatload of “science-y” talk before he delves into the woo that is homeopathy, and in this case he starts out with a relatively straightforward description of what fibromyalgia is; that is, after he asserts that “the three to six million Americans who suffer with fibromyalgia will be pleased know that several studies published in leading medical journals have found outstanding results from homeopathic treatment.” Not so fast there, Dana, as we will soon see.
Basically, fibromyalgia is a somewhat amorphous syndrome, labeled a syndrome rather than a disease because we don’t have a good handle yet on the mechanisms resulting in the condition and there are no characteristic diagnostic tests that nail down the diagnosis. In brief, fibromyalgia is a condition of chronic pain and allodynia, which is a heightened painful response to a stimulus that doesn’t normally cause pain. In the case of fibromyalgia, that stimulus is pressure. Other symptoms can include tingling of the skin, muscle spasms, limb weakness, nerve pain, muscle twitching, palpitations, bowel disturbances, and sleep disturbances. Because of the plethora of symptoms that can fall under the mantle of a fibromyalgia diagnosis and the lack of scientific consensus on its cause or specific physical findings or lab abnormalities that define the disease, there are some physicians who do not accept fibromyalgia as a defined syndrome. In my own anecdotal experience, this number seems to be decreasing. Most physicians appear to accept fibromyalgia as a syndrome, even though most don’t know how to treat it.
As you might be able to guess, because fibromyalgia is a syndrome of unclear etiology with a wide variety of physical complaints, widely varying severity, and a clinical course that waxes and wanes, it is a woo magnet. Indeed, many conditions that scientists do not yet understand well and/or for which we do not yet have particularly good treatments are woo magnets. As I pointed out back in August when I described a deceptively framed study of tai chi in fibromyalgia:
These sorts of conditions are the most frustrating of conditions to deal with, particularly for patients but also for doctors. After all, no one goes into medicine to tell patients that there’s not much he can do for them; yet that’s what doctors all too often end up having no choice but to tell fibromyalgia patients. Not surprisingly, patients are neither happy nor satisfied with this, nor should they be. They’re suffering, and they want relief. Also not surprisingly they’re willing to try almost anything, including the rankest forms of quackery peddled by unscrupulous quacks.
“CONVENTIONAL MEDICINE DOESN’T WORK WELL, SO USE HOMEOPATHY”
Before delving into the “evidence” (such as it is) for homeopathy in fibromyalgia, Ullman catalogs the lack of efficacy of many of the pharmacological and other treatments currently used for fibromyalgia. It’s hard to disagree that the current treatments we have for fibromyalgia basically, to put it bluntly, suck, nor is it my intention to try to argue that they are better than they are. On the other hand, Dana misrepresents an editorial as a review article, and that’s not cool:
In 2010, a systematic review of the most recently used conventional drugs for fibromyalgia was published in a leading scientific journal (Clauw, 2010). Although some drugs had beneficial effects, the author acknowledged the significant limitations of these benefits and the need to utilize other treatment options. He wrote, “Because of the modest overall analgesic efficacy seen with any class of analgesic drug in any chronic pain state, we should be particularly aggressive about using more non-pharmacological therapies in treating patients with chronic pain.”
The article cited by Ullman was indeed published in Nature Reviews Rheumatology. However, the article by Daniel Clauw was in actuality describing a study published in a less prestigious journal, The Journal of Pain. What Dana cited was the commentary, not the original study. Dana also cherry-picked some quotes from Dr. Clauw’s commentary, leaving out, conveniently enough, passages like this:
The authors concluded that the three drugs were superior to placebo for all outcomes noted above, with the exceptions of duloxetine for fatigue, milnacipran for sleep disturbance, and pregabalin for depressed mood.
An important lesson from these studies is that these first three approved drugs are likely to be working at the root pathogenic cause of symptom expression in fibromyalgia, rather than just ‘covering up’ a particular symptom such as pain. When individuals have a favorable response to any of these drugs, they typically improve across many symptom domains.
D’oh! How’s that for SBM “only treating the symptoms?
This is, of course, just Dana being Dana. It is also undeniably true that, advances over the last decade or so notwithstanding, we still have a long way to go in developing effective and safe treatments with few side effects for fibromyalgia patients. But does our current lack of highly effective treatments imply that we should be open to using homeopathy to treat fibromyalgia?
Not so fast, there pardner.
HOMEOPATHY AND FIBROMYALGIA
Before I move on to the discussion of the best evidence that Dana can produce for the use of homeopathy in fibromyalgia, I always find it instructive to see how a homeopath defines homeopathy, as Dana does here:
Homeopathic medicine is a 200+-year-old system of medicine that utilizes specially prepared doses of medicines made from various substances of the plant, mineral or animal kingdom. Each medicine is prescribed for its capacity to cause, if given in overdose to healthy people, symptoms similar to those that the sick person is experiencing. Because basic physiology recognizes that symptoms represent defenses of the body (and mind) in its efforts to fight infection and/or adapt to stress, a homeopathic medicine is selected for its capacity to mimic a person’s own symptoms, thereby augmenting their own defensive response.
Just as vaccines and allergy treatments are in part based on this same premise — whatever a substance causes in overdose, it will elicit an immune response when taken in small doses — homeopathic medicines are a system of helping the “wisdom of the body” defend and heal itself.
In other words, it’s the same nonsense that homeopaths have been saying for 200 years, with the added nonsense of comparing homeopathy to vaccination. Fortunately, Dr. Crislip just covered that very topic so that I don’t have to again. Perhaps most gratifying of all, Ullman admits:
In homeopathy, ALL ailments are considered “syndromes,” that is, all disease is a constellation of physical and psychological symptoms, and each patient has his or her own subtly different syndrome of a disease. The fact that people with fibromyalgia tend to have sometimes slightly or overtly differing symptoms from each other is no significant problem for homeopathic treatment. In fact, homeopathic treatment tends to be easier when patients have idiosyncratic or unusual symptoms.
Actually, I’ll buy that last sentence, but not for the reasons Ullman gives. The real reason that homeopathic treatment appears to “work” better for patients with idiosyncratic or unusual symptoms is not because homeopathy “works” for anything beyond placebo effects. Rather, it’s because such patients tend to have syndromes, conditions, or diseases that SBM currently can’t treat very well.
Conditions like fibromyalgia.
So let’s look at the evidence. Before we do, one should note that, as Kimball Atwood has pointed out time and time again, RCTs can be wrong. Indeed, in an ideal world, even a perfectly conducted RCT has a 5% chance of producing a false positive result by random chance alone. Add the factors described by John Ioannidis and the observation that, the more implausible the hypothesis being tested, the more likely there are to be false positive results in RCTs, it’s quite possible to find a clinical trial that appears to show efficacy for homeopathy. The key word is appears.
The first study (PDF here) cited by Ullman is actually somewhat interesting. It tested a 6C dilution, which is only a 1012-fold dilution, of Rhus toxicodendron. That means that, unlike most homeopathic remedies, there is actually some active substance left, which makes it possible, albeit unlikely, that whatever extract was in the homeopathic remedy might actually have a pharmacological effect. It was also a very small study (30 patients), which are exactly the sorts of studies that are most likely to have a false positive result. Moreover, it was done more than 20 years ago, which was an era when the diagnostic criteria for fibromyalgia hadn’t been firmed up. More importantly, Dana left out a huge bit of information, namely that David Colquhoun reanalyzed the data of Fisher et al and found that “this re-analysis shows that the trial of Fisher et al provides no firm evidence for the efficacy of homeopathic treatment for fibrositis.” In other words, Fisher’s trial is not compelling evidence–or even good evidence at all–for a specific effect due to homeopathy on fibromyalgia.
Next, Ullman cites four papers by Bell et al at the University of Arizona. Two of the studies were published in real journals (here and here), two in the woo journal Journal of Alternative and Complementary Medicine, whose history of publishing dubious CAM research makes it an unreliable source, at best. These studies are also fairly underwhelming, as is the trial by Relton et al published last year. For one thing, all the studies by Bell et al suffer from low numbers of patients, as usual. For another thing, Bell hasn’t published anything on fibromyalgia since 2004. Whenever someone like Dr. Bell publishes a flurry of papers in a single year and then nothing for six years after, it always raises red flags. Specifically, it makes me wonder whether Dr. Bell couldn’t replicate her own results in order to move on. Also, in the Rheumatology paper, I notice several flaws in the randomization in characteristics that are important disease endpoints, which means that the two groups aren’t the same when it comes to severity. Moreover, the treatment group and placebo group differed in the number on antihistamines; the authors claim this didn’t make a difference but present no evidence to show that this is so. Finally, in Table 2, one notes that there are no differences in any of the endpoints for the study groups until the results are “adjusted,” which always sends up red flags for me.
In the end, all Ullman has are a handful of studies, all of them relatively small, all of them with not particularly convincing results. As Edzard Ernst put it in his recent systematic review of homeopathy for the treatment of fibromyalgia, which includes a discussion of each of the RCTs cited by Ullman:
Even though our searches were thorough, we cannot be sure that all relevant RCTs were located. Negative studies tend to remain unpublished . This bias could therefore have distorted the overall picture. All the four RCTs tested different homoeopathic treatments or approaches; this means that no independent replication of any of the tested approaches exists. The paucity and, at times, disappointing quality of the available RCTs render firm conclusions problematic.
In summary, the findings of the four existing RCTs all favour homoeopathy over controls. Yet none of the studies is sufficiently rigorous to provide a definitive answer. Future studies should minimise bias more effectively than did the trials available so far.
Another point is that, with the exception of the last study in which homeopaths could choose whatever remedies they wish, all of these studies used rather “weak” dilutions of the homeopathic remedy, usually on the order 6C. At such a dilution, it is quite possible that there remains a significant amount of remedy left in the homeopathic concoction, although it’s unlikely to be a pharmacologically relevant amount because it’s diluted 1012 times.
More to the point, Ernst writes:
When evaluating the evidence for or against homoeopathy one should briefly comment on the plausibility of this treatment. Homoeopathy is based on two main principles. The Law of Similars claims that, if a substance causes symptoms in healthy volunteers, it can be used to treat these symptoms effectively when they occur in patients. The law of the infinitesimal dose holds that, if a substance is serially diluted in the homoeopathic way, it becomes not weaker but stronger, even if the dilution is beyond Avogadro’s number. Currently, there is little scientific evidence to support these theoretical principles. It is therefore difficult to accept that homoeopathy is biologically plausible.
Actually, Ernst is actually understating the point. Perhaps the reviewers forced him to tone it down. As I’ve said before, homeopathy is beyond just “biologically implausible.” It’s so implausible from a basic science standpoint alone that, for homeopathy to work, huge swaths of our current understanding of physics, chemistry, and biology would have to be not just wrong, but spectacularly wrong. Huge sections of science textbooks would have to be rewritten. Of course, as a skeptic, I have to concede that it is possible that this is so. However, given the mountains of evidence that show that homeopathy can’t work, it would take mountains of evidence of similar size and rigor to make scientists start to think that homeopathy can work.
Believe it or not, I’d be perfectly willing to reconsider my skepticism of homeopathy if homepaths could produce in support of their woo 1% of the evidence that currently exists to show that homeopathy doesn’t work. Small clinical trials don’t count, particularly given their flaws and the very real possibility of publication bias, in which positive trials are far more likely to be published than negative trials. Couple that with the very nature of the condition upon which homeopathy was tested, and the results of these handful of trials are even less convincing. After all, fibromyalgia is very prone to placebo effects, regression to the mean, and confirmation bias when assessing therapies. Personally, I find the study testing tai chi on fibromyalgia to be far more convincing than any of the trials of homeopathy here. Of course, in that case, I also didn’t see any compelling evidence why tai chi would be any more effective than any other similar gentle exercise.
Apparently burned by past criticism, Ullman concludes his post with a hilarious “note to and about skeptics of homeopathy.” Dana being Dana, it’s an amusing bit of woo-ful weasel words. I find it particularly appropriate that, in light of recent posts by both Kimball and myself, Dana decides to pull out this hoary alt-med argument for homeopathy:
These fundamentalists also love to assert that “there is no plausible mechanism” for how homeopathic medicines work. Such statements display a serious ignorance of medical history because people who say this ignore the fact that it was only relatively recently did physicians understood how aspirin worked, and yet, no doctor (or patient) chose to not use this drug simply because the mechanism of action was not adequately understood.
Can you say “straw man” argument? Sure, I knew you could. Just read Kimball‘s and my posts if you don’t believe me. As Kimball so eloquently put it, “Plausibility ≠ Knowing the Mechanism.” The point is not that we have to know in detail the biological and chemical mechanisms by which any given treatment to be tested is thought to work. The point is that any proposed mechanism or mechanism that would have to be in force if a treatment worked, whether that mechanism is proposed or not, should not violate known physical laws whose foundation rests on, as Kimball put it, “far more solid ground than any number of equivocal, bias-and-error-prone clinical trials could hope to overturn.” Or, as I put it earlier in this post, implausibility is the key. If, based on well-established science, a therapy’s mechanism is so implausible that multiple well-established laws science would have to be totally wrong, then that particular therapy will require an equivalent amount of evidence in its favor to make us begin to doubt those physical laws. As Carl Sagan put it, extraordinary claims require extraordinary evidence, and homeopathy makes some doozies of extraordinary claims.
Dana pulls out some true howlers in his criticism of “skeptics” as well. For instance:
Some “deniers” are audacious enough to suggest that the “weight of evidence” evaluating homeopathy shows that these medicines do not have any benefit beyond that of a placebo. Was Thomas Edison’s discovery of electricity false because 999 experiments failed to produce electricity and only one that was successful? Is the weight of evidence that he failed?
Deniers will inevitably assert that Edison’s discovery is proven every day, and yet, homeopaths likewise will say that homeopathy is proven every day by the hundreds of millions of its users worldwide, including many of the most respected scientists, physicians, corporate leaders, political leaders, clergy and spiritual leaders, literary greats, sports superstars, and every day average people.
Thomas Edison’s work didn’t violate known physical laws, and, more importantly, the proof was undeniably in the pudding. His lights worked. Of course, to Dana homeopathy works, but I’d point out that it’s undeniable that lightbulbs work. It’s quote deniable that homeopathy does, even under the best circumstances. (Show me homeopathy curing a case or two of a deadly disease rather than conditions with waxing and waning symptoms prone to placebo effects–pancreatic cancer, for example–and I might reconsider.) It’s also amusing to see Dana, after having criticized skeptics for not knowing history, falsely attribute the discovery of electricity to Thomas Edison. Edison did some fantastic work with electricity and did invent the a practical electrical lightbulb that came to be the standard bulb used for over a century, but he didn’t discover electricity.
Ullman also can’t resist a couple of his favorite gambits. First, there’s special pleading, in essence, the claim that “you can’t study my woo in RCTs.” Then, of course, there’s the infamous pharma shill gambit, which Ullman applies with gusto:
Sadly, many people who claim to be skeptics are simply representatives of Big Pharma. In England, the leading anti-homeopathy organization, Sense about Science, is led by a former public relations expert who has a long history of representing Big Pharma companies (SourceWatch.org – see link in References).
Even if that were true, it would not change the fact that homeopathy is nothing more than sympathetic magic, combining the law of similars and the law of contagion. It’s magical prescientific thinking.
There’s a reason why homeopathy endured for nearly a hundred years as a “respectable” bit of medicine, even despite the knowledge among scientists that it was bunk dating back to the early 1800s. It’s because the “allopathic” medicine of the time frequently used remedies that were worse than useless; some were actively harmful, such as bleeding and purging with toxic metals like mercury and cadmium. In comparison, homeopathy could easily appear to do better, because, well, it’s water and therefore at least didn’t do any active harm. Many diseases would resolve spontanously for a significant fraction of patients anyway. However, as medicine became more science-based, it started to be able to offer actual treatments that did some good, and homeopathy had nothing to offer but magic.
Still, there are a lot of people who still believe in magic. Because RCTs are complicated and there are many conditions and diseases that are difficult to diagnose and treat, it will always be possible for people like Dana Ullman to use science-y-sounding language and cherry-picked studies to make it sound as though homeopathy is anything more than witchcraft (choice of words intentional).
And it will be possible for wretched hives of scum and quackery like HuffPo to give people like Ullman a platform.
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