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Oscillococcinum

(This entry is about a scientific study of the effectiveness of one of the most popular homeopathic flu remedies, Oscillococcinum. It was taken from an exchange with an M.D. who practices homeopathy and thinks this is a first-tier study.)

In the study, 237 received Oscillococcinum homeopathic pills (oscillo), a homeopathic product from Boiron Laboratories in France. (Yes, this is the same company that supported Jacques Benveniste.) The product is made from a combination of wild duck heart and duck liver. It sells for about the price of a flu shot and is a $15 million-a-year business in the U.S., but is much more popular in Europe.* The active ingredients listed on the packaging of oscillo are written in Latin and mean extract of the liver and heart of a Barbary duck: Anas Barbariae Hepatis et Cordis Extractum. It is diluted one part in a hundred 200 times, which means there are no duck molecules left in the final product. Bob Park calculates that the last duck molecule is vanquished after about 12 dilutions. If  the entire universe consisted of nothing but oscillo, there would be no molecules of the stuff left after about 40C.* Or something like that. You get the picture. One duck could produce enough oscillo to supply everyone on earth and all their offspring for millions of years with a lifetime supply. Please, no quack jokes, but now you understand why I put "active drug" in scare quotes.

I know that most skeptics stop right here and say that homeopathic potions can't work because there's nothing in them. (Bob Park, for example, simply asserts that no homeopathic remedy has ever passed the test of a randomized, placebo-controlled, double-blind trial. Park doesn't examine any studies, though he did try for five years to get Jacques Benveniste to collaborate with him on a simple test.*) I'm not going to stop here, however. I'm going to look at the study and examine the methods, protocols, size of samples, use of controls, randomization, clear and specific starting points and ending points, justification of conclusions, and the like. I'm not going to worry about the fact that there's no active ingredient in the homeopathic potion we are testing.

But first, a little history.

The word Oscillococcinum was coined in 1925 by the French physician Joseph Roy (1891-1978) who said he had observed an oscillating bacterium in the blood of flu victims. He searched for the bacterium in several animals until he found it on the liver of a duckling.*  (Dr. Mirman supplies more information below as to why the innards of ducks might be a good place to develop an anti-flu potion: migrating ducks are natural reservoirs of influenza viruses.) Okay. That's enough history.

Bob Park has a chapter in Superstition: Belief in the Age of Science called "The Barbary Duck," in which he discusses this very popular potion sold worldwide as something that will relieve influenza-like symptoms. (For those who are into diluted details, consider the following: "In some regions the name Barbary Duck is used for domesticated and "Muscovy Duck" for wild birds; in other places "Barbary Duck" refers specifically to the dressed carcass, while "Muscovy Duck" applies to living C. moschata, regardless of whether they are wild or domesticated. In general, "Barbary Duck" is the usual term for C. moschata in a culinary context.) You can buy this product  in America off the shelf. It is not regulated by the FDA. In fact, no homeopathic remedy is regulated by the FDA because the 1938 Food, Drug, and Cosmetics Act specifically excludes most homeopathic potions from FDA oversight. note

In the Ferley study, there were 478 participants, this study is certainly large enough. Nine participants were excluded because they did not meet the eligibility criteria: 5 from the homeopathic group and 4 from the placebo group. Why they were admitted in the first place isn't discussed.

As noted above, the study used a rectal temperature of 39 °C (101 °F) to be eligible and 37.5 °C (99.5 °F) as an objective measurement of recovery. According to Wikipedia:

Although the value 37.0 °C (98.6 °F) is the commonly accepted average core body temperature, the value of 36.8 °C ±0.7 °C, or 98.2 °F ±1.3 °F is an average oral (mouth under the tongue) measurement. Rectal measurements ... are typically slightly higher....

Body temperature normally fluctuates over the day, with the lowest levels around 4 a.m. and the highest in the late afternoon, between 4:00 and 6:00 p.m. (assuming the person sleeps at night and stays awake during the day). Therefore, an oral temperature of 37.2 °C (99.0 °F) would, strictly speaking, be normal in the afternoon but not in the morning. An individual's body temperature typically changes by about 0.5 °C (0.9 °F) between its highest and lowest points each day.

Thus, some might quibble about the use of temperature to determine eligibility and recovery. The participants would have visited the clinic for the first time at various times during the day, but ideally they should all have had their readings at the same time of day. Likewise for the readings they did at home in the morning and evening. Depending on what time of the morning or evening, temperatures could fluctuate and skew the outcome. It seems that if temperature typically changes by about 0.5 °C between its high and low points each day, some participants might be designated as recovered and some as not recovered because of the time of day they took their temperatures. It might be more appropriate to use a range of temperatures as indicating recovered: for example, say, 37.25 °C to 37.75 °C (99.05 °F to 99.95 °F). In my view, however, I think that with the size of these samples, it is likely that any bias in the groups due to variations in temperatures during the day would cancel each other out.

So, what did the research show?

The data show that the vast majority of participants (86.4%) did not recover in 48 hours. In the oscillo group, there were 39 (17.1%) recoveries and in the placebo group there were 24 (10.3%).

Not surprisingly, the researchers found that younger people and those with less severe symptoms recovered more quickly than older people or those with severe symptoms. Two unusual stats stand out, however. The number of recoveries among those under 30 was three times higher in the oscillo group (21 to 6) and the number of recoveries in the mild-to-moderate severity group was twice as high in the oscillo group (31 to 16). Such differences are not likely due to chance. There was no significant difference in the two over-30 groups.

There was almost no difference in the numbers in each of the 12-29 age groups that had not recovered within 48 hours. Sixty-three of the oscillo group were still sick after 48 hours, while 68 of the placebo group hadn't recovered yet. For some reason, the numbers don't add up in the chart provided by the authors for recovery according to age and treatment group. The number in the oscillo group has dropped to 207 and the number in the placebo group has dropped to 205. The authors note that there was a mild flu that season and don't indicate that anyone in the study died, but the data for 21 in the oscillo group and 29 in the placebo group are missing.

The researchers established to their satisfaction that even though the participants weren't supervised during the study, neither group was taking more antibiotics or cold medicines. They did find that the control group took more drugs for pain and fever (50.2% to 40.7%).

Finally, 61.1% of the oscillo group thought the treatment worked, while 49.3% of those taking a placebo thought it was effective. It is not specified by the authors, but it seems reasonable to assume that the participants gave this assessment after the study had concluded. The patients were asked to keep records for one week. Most flu symptoms during a mild flu will last about a week, so the felt recovery may have had nothing to do with actual effectiveness. Anyway, finding out that more than 60% of a group felt a medicine was effective sounds impressive until you find out that 50% who are given a placebo agree with them. Subjective measurements are interesting, of course, but they don't tell us anything about the effectiveness of the medicine. At least in my book, patient satisfaction is not equivalent to drug efficacy.

A statistical formula shows that the odds of the 6.8% difference in recovery being due to chance are 3 in 100. However, if about 1.7 percent of those given oscillo went the other way and didn't recover, and about 1.7 percent more of those given the placebo had recovered, we wouldn't be evaluating this study. All it would take would be a different outcome for 3 or 4 in each group to make it obvious that nothing unusual is going on here. For example, if the number of recoveries in the oscillo group had been 35 instead of 39, and the number of recoveries in the placebo group had been 28 instead of 24, the percentage difference between the two groups would drop to 3.4% (15.4% and 12%, respectively), a difference you might expect between any two groups of several hundred people with flu symptoms, both of which were given placebos.

The authors conclude their summary of the study by commenting: "The result cannot be explained given our present state of knowledge, but it calls for further rigorously designed clinical studies." I'm surprised that a peer-reviewed journal would allow such a statement to preface a published study. (The statement is repeated near the end of the paper.) Since this is a study on a homeopathic potion, it is likely that this claim will be understood to mean that we found the potion works significantly better than a placebo, but we have no way of explaining how any homeopathic remedy works. The claim is ambiguous enough, however, to mean (if one is generous in interpretation) that the study found that the homeopathic potion got better results than a placebo and the authors can't come up with an explanation for the data in terms of our present state of knowledge regarding causal mechanisms and studies. But they don't have to. All they have to say is that this difference could be a statistical fluke and more studies should resolve the issue.

Making sure everybody takes their rectal readings at the same times each day and night might yield slightly different results. Controlling for age before final analysis of the data might yield slightly different results.

So, the next question is: have all the studies done in the twenty years since this one was published helped to resolve the issue?

Not really.

Why?

Because there haven't been any follow-up studies. Twenty years have gone by and not a single attempt at replication of this study has been published. The authors admit that the difference they found between the two groups was "modest." They certainly did not find evidence of a robust effect from the homeopathic brew. What they found, they said, was "interesting." Maybe so, but why has nobody done a follow-up? One would think that at least one study would have been done on young people with mild flu symptoms, since the differences in those groups were the greatest of those measured in the study.

The authors recognize that the differences measured, while statistically significant, are not sufficient to establish a causal relationship between oscillo and recovering from the flu. They note that "it would be unwise to claim that the study has demonstrated a cause and effect relationship between the drug and the recoveries." Yet, in the very next sentence they write: "The positive effect of the homeopathic preparation cannot be explained in our present state of knowledge...." As they themselves note, they didn't establish a causal relationship between oscillo and recovery from the flu. They didn't prove effectiveness. They found a statistically significant difference between two groups. More studies might provide strong scientific evidence that oscillo causes some reduction of some flu-like symptoms in some people.  Even so, if more studies replicate this one, the effect of the oscillo is so small as to be of little medical value. Would you buy a remedy that brags about being 10% more effective than a placebo or helps some people some of the time or helps with flu symptoms in 2 out of 10 cases?

It has been over 20 years since this study was published and nobody replicated it.

Why?
____________

Note: This claim needs some clarification. As Dr. Steven Novella writes: "Homeopathic remedies are classified as “drugs” by the FDA, which means they fall under FDA oversight, but at the same time they are granted automatic approval as long as they appear in the Homeopathic Pharmacopeia. What this means is that the Homeopathic Pharmacopoeia Convention of the United States, the non-governmental agency that writes the homeopathic pharmacopoeia, only has to add an agent to their list and it is granted automatic FDA approval....But because homeopathic remedies do fall under FDA regulation the FDA has the power to decide that a product poses a safety risk to the public and therefore can demand evidence for safety."

If you followed the link from the picture of the oscillo box above, you will find that the ad on Amazon states that the product is  "Regulated as a drug by the FDA." This is very misleading because the only way a homeopathic drug can be banned by the FDA is if it shown to be harmful in itself, which is impossible since there are no active ingredients in the products. (This is also misleading and confusing because of complex homeopathy and the fact that there are products on the market with active ingredients that are labeled homeopathic.)

If you gave five unlabeled homeopathic drugs in look-alike vials of liquid to a team of homeopaths and asked them to identify what each vial contains, they couldn't do it because they have nothing to look for to distinguish one drug from another. I venture that you could mislabel every drug in a homeopath's pharmacy and get the same level of satisfaction from both homeopath and patient.

One of the most hilarious press releases I've ever read came from the French equivalent of the FDA announcing a recall of two homeopathic drugs because they had been mislabeled. The agency said: "...this mix-up does not pose any particular risk . . .” No kidding.

further reading

new Class Action Lawsuit Filed against Homeopathy Manufacturer Boiron and Shoppers Drug Mart A $30 million class action lawsuit has been filed by leading Canadian class-action law firm Roy, Elliott, O’Connor (REO), in partnership with Centre for Inquiry Canada. It follows an open letter sent by CFI’s Committee for the Advancement of Scientific Skepticism (CASS) to Shoppers Drug Mart, demanding that it cease selling worthless homeopathic products such as Oscillococcinum, Boiron Inc.’s popular homeopathic flu remedy. In the new lawsuit against both Shoppers and Boiron, REO alleges that the two companies have, through their marketing of Oscillococcinum, committed no fewer than twelve separate violations of consumer protection acts. [/new]

Leading Scientists and Physicians Rebuke Walmart for Selling Ineffective Flu Remedies The Committee for Skeptical Inquiry (CSI) and the Center for Inquiry (CFI) have issued a joint statement criticizing retail giant Walmart Stores, Inc.’s misleading promotion on its website of a homeopathic medicine as a treatment for the flu. Prominent scientists and medical specialists have joined CSI and CFI in publicly calling for Walmart to end its promotion of Boiron Oscillococcinum, a purported remedy for flu symptoms.

The rebuke should extend to other stores as well. In my area (Davis/Woodland/Sacramento, CA) Costco, Target, CVC, and RiteAide all carry and promote Oscillococcinum and other junk remedies such as Airborne.

Last updated 14-Apr-2012

This page was designed by Cristian Popa.