# Homeopathy for breast cancer surgery? Isn’t it bad enough that the patient has cancer and needs a mastectomy?

I like to refer to homeopathy as The One Quackery To Rule Them All, so much so that I almost always call it that within the first two paragraphs of any post I write about some tasty bit of homeopathy pseudoscience. It’s also a wonderful tool for teaching critical thinking because it’s easy to explain and people grasp intuitively why homeopathy is pseudoscience when it’s explained properly to them. Basically, it’s because of homeopathy’s two laws. The first is the Law Similars, which states that, relieve a symptom, you must use something that causes the symptom. It’s nonsense. There’s no science behind a general rule like that. Then, there’s the second law, the law of infinitesimals, which states that a remedy gets stronger with dilution. That’s why homeopaths serially dilute their remedies—with intense shaking between each step of dilution (homeopaths claim that the shaking, or succussion, is absolutely essential)—to the point where it is unlikely that there is a single molecule of the remedy left. For instance, a 30C homeopathic remedy is a remedy that’s been diluted 100-fold thirty times, which results in a total dilution of 10-60. Given that Avogadro’s number (the number of molecules in a mole of a chemical) is roughly 6 x 1023, that means a 30C dilution is over 1036 more than Avogadro’s number. Most people think that homeopathy is nothing more than herbal medicine and have a hard time believing it when I tell them what homeopathy really is.

All of this why skeptics frequently say that homeopathy is water, using that observation as the basis for jokes. Now, it’s true that some “weaker” (i.e., less dilute) homeopathic remedies haven’t been diluted enough times to dilute the original remedy to nothing (i.e., there’s still something left), but most homeopathic remedies are, in fact, water or ethanol or whatever homeopaths used to dilute the remedy, usually pressed into sugar pills. A purer placebo, it is hard to imagine.

That’s why it never ceases to amaze me when actual surgeons—even worse, breast cancer surgeons, my peeps!—forget everything they were taught in undergraduate and medical school about chemistry and physics and think that it’s worthwhile to test a homeopathic remedy in a randomized clinical trial for breast surgery. After all, in such a trial, no matter what you choose as the placebo control, you’re testing placebo versus placebo. In this case, it’s surgeons in Italy, along with what appear to be basic scientists, testing the effect of a homeopathic remedy on healing in breast surgery. The remedy being tested is even more clearly water than even a 30C remedy. This time, the remedy being tested is Arnica montana, which is also known as wolf’s bane, a flowering plant that is a member of the sunflower family. It’s a common homeopathic remedy, and in this case it’s really, really, really dilute:

A. montana 1000 K was in the form of drops in 30% hydro alcoholic solution, with sublingual absorption. The 1000 K dilution is a very high homeopathic dilution produced according to the French Pharmacopoeia, starting from a mother tincture (complete plant extract) which undergoes 1000 steps of successive dilution and shaking in a 30% water–alcohol solution. The mother tincture of the product used in this study contained a minimum content of 0.04% of sesquiterpenes (expressed as dihydrohelenanin tiglate). According to the Korsakovian dilution method, the same flask was used for the entire preparation: At each step, the flask was emptied of most of the liquid but not dried, and then immediately filled again with the solvent. Because the residual volume after emptying the flask certainly cannot be >10% of the total used in each dilution, the 1000th K dilution is sufficiently high that it certainly does not contain toxic amounts of the plant. The placebo drops were identical in appearance to the active drops, but included only 30% hydro alcoholic solution without any homeopathic dilution. The studied homeopathic treatment and the placebo were manufactured and supplied in strictly identical packaging by Laboratoires Boiron S.r.l. (Segrate, Milan, Italy).

So what we’re talking about is one thousand 100-fold serial dilutions, resulting in a final 10-2000 dilution. This is madness, as it’s estimated that there are only around 1080 particles in the known universe. Seriously, all that is left there is 30% alcohol. So basically the study I’m examining is testing the effect of 30% alcohol on wound healing in breast surgery. You’ll see what I mean. Here’s the rationale:

Surgery is not free from significant complications, despite advancement in surgical techniques and in perioperative care. One of the major complications, particularly for breast and soft tissues surgery, is post-operative bleeding which represents a critical and, in some cases, lethal risk factor [1,2]. Moreover, post-operative bleeding after breast surgery causes a severe discomfort to the patient, entailing the need for surgical re-intervention and sometimes blood transfusions. Another frequent complication of breast surgery is seroma, which often requires numerous accesses for outpatient drainage, finally resulting in a delay of adjuvant therapy administration and a significant psychological burden [3].

All of which is true, but doesn’t justify this:

The risk of blood loss or seroma could be limited by identifying and then correcting potential triggers, but although this topic has been extensively studied, both hemorrhage and seroma are still largely reported [4,5]. Homeopathy could provide remedies based on compounds with anti-hemorrhagic and anti-inflammatory properties, but their use in diluted homeopathic solutions has been poorly investigated [6-9]. Indeed, some homeopathic remedies have been already evaluated in various surgical settings, however showing controversial effects [10-17]. Arnica montana is a plant belonging to the Compositae family and it grows in East and Central Europe [18]. In particular, its anti-inflammatory action is linked to the lactone helenalin that seems to be involved in the inhibition of the pro-inflammatory transcription factor nuclear factor kappa B (NF-κβ) [19-27]. A. montana has been recently evaluated in several surgical settings such as esthetic and orthopedic surgeries, but currently, no single study is available in literature on the effects of this homeopathic remedy in breast cancer surgery. In the present study, a homeopathic preparation of A. montana 1000 Korsakovian dilution (1000 K) was administered preoperatively and postoperatively in a placebo-controlled, double-blind clinical trial to patients undergoing unilateral total mastectomy, with or without reconstruction, to evaluate any favorable or adverse effect on post-operative blood and seroma collection from surgical drains.

OK, let me back up and do a bit of explaining here. After a mastectomy, we generally place a drain under the skin flap in order to collect the drainage, which starts out bloody but clears up until it’s serum, usually pink with a little bit of blood mixed in. When the drainage decreases to below a certain volume per day, the drains are removed. Patients don’t like drains because they’re inconvenient, messy, and can clog, but without drains, it’s almost inevitable that there will accumulate something that’s called a seroma, which is a collection of that serous fluid under the skin flap left after the mastectomy. Sometimes two drains are placed, usually when the patient has her axillary lymph nodes (the lymph nodes under the arm) removed, because the cut lymph vessels also leak lymph and can result in a seroma.

In this study, the investigators studied the effect of 1000K A. montana compared to placebo on the following endpoints:

• Duration of drainage, which was calculated from day 1 to the day of drainage removal
• Time to reach a collected volume below 10 ml
• Self-evaluation of pain, measured by VAS after surgery
• The average time of hospitalization after surgery, which was measured in days following surgery
• The presence of bruising and hematomas or breast swelling, measured both in terms of presence versus absence and of description or size
• The differences between the volume collected on day 1 and the volume collected in each of the following days
• Possible adverse reactions to treatment.

The patients were randomized to one of two grsoups:

The patients, according to the randomization list, received sublingually a dose of five drops of A. montana 1000 K 3 times a day, or placebo with identical times of administration, from 1st day before the surgery until the 4th day after the surgery (in total 6 days).

The results were analyzed using three models:

• Model 1: Includes the treatment;
• Model 2: Includes the treatment and the volume collected on the day of the intervention;
• Model 3: Includes the treatment, the volume collected on the day of surgery, and patient weight.

Overall, 53 women were enrolled and randomized (26 in the A. montana group and 27 in the placebo group). One defect in this paper is that it didn’t show a proper CONSORT flow diagram, which is generally mandatory for any halfway decent clinical trial. Be that as it may, what did the investigators find?

Nothing that spectacular:

The per-protocol analysis revealed a lower mean volume of blood and serum collected in drainages with A. montana (−94.40 ml; 95% confidence interval [CI]: 22.48-211.28; P = 0.11). A regression model including treatment, volume collected in the drainage on the day of surgery, and patient weight showed a statistically significant difference in favor of A. montana (−106.28 ml; 95% CI: 9.45-203.11; P = 0.03). Volumes collected on the day of surgery and the following days were significantly lower with A. montana at days 2 (P = 0.033) and 3 (P = 0.0223). Secondary end points have not revealed significant differences.

The first thing to notice is that there really wasn’t a lower mean volume in blood and serum collected in the patients treated with the homeopathic remedy. the p-value was only 0.11. Now, apparently the criterion used by these surgeons for removing the drains was 10 ml/24 hours, because that was the endpoint the investigators looked at. My criterion is a bit more liberal. Be that as it may, the results are not impressive. For instance, take a look at this graph, which shows the change in drainage after day 1:

Yes, there does appear to be a slightly higher amount of drainage in the placebo group. It doesn’t matter though. When it comes to breast surgery, what matters is not so much how much drainage is collected through the drains, but how many days before the drains can be removed. That number is the same for the placebo and homepathic A. montana groups.

To drive home the point, look at this graph, which shows the time for each group to reach a <10 ml of drainage/24 hours:

Basically, there was no difference, as I would expect. Certainly there is no clinically significant difference. Even the authors seem to know that:

In this study, which to our knowledge is the first to test the effect of A. montana in breast cancer surgery, we have measured the efficacy of the homeopathic treatment versus placebo in reducing the post-operative bleeding and seroma production in patients subjected to total mastectomy. The difference in the volume of blood and serum collected by drainages between the group of women treated with A. montana and those treated with placebo was statistically significant in the PP dataset, but only in the model which included, in addition to the type of treatment, the volume collected on the day of surgery, and the weight of the patient. Thus, we determine that these two additional variables have a considerable effect on the efficacy of the treatment, and further studies are needed to investigate their specific contributions.

Um, no. Basically you had to keep trying different models until you found one that produced a (barely) statistically significant result. I do have to give the authors props for this unintentionally hilarious observation:

The main limitations of the study were the relatively small sample, the analysis of post-operative recovery, which was limited only to 5 days, and the use of a high Korsakovian dilution which could have negatively impacted on the statistical significance of our findings. Observational studies with different Korsakovian dilutions could be useful to highlight any significant effect of A. montana and further validate these findings.

No. They. Could. Not. Be.

And this statement sums up every homeopathy study ever:

The scientific community often claims that homeopathy effects are not supported by rigorous clinical trials. This study, although reporting statistical significance only for some specific data settings, suggests a reduction in post-operative blood loss and seroma production in a group of women who underwent breast cancer surgery and treated with A. montana 1000 K.

Seriously, this is about as negative a study as can be imagined, just like every other study of homeopathy that’s anywhere near competently designed and carried out. That’s because homeopathy is water, or, in this case, 30% ethanol in water. At the dosage given, it there’s not even enough alcohol there to give you a little buzz. It’s like taking a teaspoon of cough syrup, many of which also have alcohol in them.

Once more, here we have a pseudoscientific and unethical clinical trial that shows…nothing. That’s appropriate, though, because homeopathy is basically nothing.

## By Orac

Orac is the nom de blog of a humble surgeon/scientist who has an ego just big enough to delude himself that someone, somewhere might actually give a rodent's posterior about his copious verbal meanderings, but just barely small enough to admit to himself that few probably will. That surgeon is otherwise known as David Gorski.

That this particular surgeon has chosen his nom de blog based on a rather cranky and arrogant computer shaped like a clear box of blinking lights that he originally encountered when he became a fan of a 35 year old British SF television show whose special effects were renowned for their BBC/Doctor Who-style low budget look, but whose stories nonetheless resulted in some of the best, most innovative science fiction ever televised, should tell you nearly all that you need to know about Orac. (That, and the length of the preceding sentence.)

DISCLAIMER:: The various written meanderings here are the opinions of Orac and Orac alone, written on his own time. They should never be construed as representing the opinions of any other person or entity, especially Orac's cancer center, department of surgery, medical school, or university. Also note that Orac is nonpartisan; he is more than willing to criticize the statements of anyone, regardless of of political leanings, if that anyone advocates pseudoscience or quackery. Finally, medical commentary is not to be construed in any way as medical advice.

To contact Orac: [email protected]

## 34 replies on “Homeopathy for breast cancer surgery? Isn’t it bad enough that the patient has cancer and needs a mastectomy?”

Anonymous Pseudonymsays:

Would this drainage be affected by the person being dehydrated? If so, up the alcohol amount and proportion and soon enough, the person will be too blitzed to care about the drainage, and the lack of fluids will reduce it to the required level in no time. 🙂 See.. Doubting Thomas. Homeopathy can work. 🙂

For the humour impaired. This is called a joke. A poor attempt maybe, but a joke none the less.

Chris Hickiesays:

This “study” comes from “The Journal of Intercultural Ethnopharmacology”, whose home page states:

The Journal of Intercultural Ethnopharmacology is aimed to serve an intercultural contemporary approach to the knowledge about world-wide usage of complementary medicine and their empirical and evidence-based effects.

So this “study”, showing no evidence-based effects, should not have been published based on their results.

Homeopathy could provide remedies based on compounds with anti-hemorrhagic and anti-inflammatory properties, but their use in diluted homeopathic solutions has been poorly investigated [6-9].

Yes, because homeopathic protamine sulfate and homeopathic levofloxacin have worked so well (s/o)

Recently I’ve gotten myself involved in a typical fight over the internet regarding alternative “medicine” and homeopathy. That’s how I got to know that France is a country that wholly embraces MAC and all that stuff! They even have a statement regarding that subject on an official website:

http://www.hopital.fr/Vos-dossiers-sante/Prises-en-charge/Medecines-alternatives-et-complementaires

Now that is crazy. Well, the country I live in is crazy enough, but at least we don’t get to offer sugar balls as a legit treatment. Honestly, if MAC ever spreads to my national standard healthcare, I will gladly surrender my license.

Danial Corcossays:

“breast cancer surgeons, my peeps!—forget everything they were taught in undergraduate and medical school ”
Maybe this reflects strange reasoning from breast cancer surgeons. I know some who believe that when a breast cancer is larger than 2 cm, it will kill the patient if left untreated, but if it is between 1 and 2 cm it may regress spontaneously. This is nonsense, since the lifetime of a cancer between 1 and 2 cm is much shorter than from initiation to 1 cm.

Eric Lundsays:

So not only did a bunch of alleged scientists think a 1000K homeopathic remedy (not sure if that is C dilutions or M dilutions, but with that many dilutions the distinction is irrelevant) was worth a clinical trial, but one or more IRBs or equivalent bodies agreed.

<voice=”Lloyd Bridges”>Looks like I picked the wrong week to quit Coca-Cola.</voice>

Christine Rosesays:

“Surgery is not free from significant complications, despite advancement in surgical techniques and in perioperative care…. resulting in a delay of adjuvant therapy administration and a significant psychological burden [3]. ”

Seriously, this is my sister. My sister RIGHT NOW. She was sent home on Tuesday because her incision is too messed up for chemotherapy. And the first round of (neoadjuvent) chemo resulted in sepsis, 12 days in the hospital, another two weeks of intravenous antibiotics, at which time she skipped directly to mastectomy, which was followed by clogged drains and yet another infection.

Anybody who gets close to her with A. montana is likely to suffer serious injury. Sheesh.

This “study” comes from “The Journal of Intercultural Ethnopharmacology”

Part of the Ejmanager LLC stable, which predictably was on Beall’s list.

The risk of blood loss or seroma could be limited by identifying and then correcting potential triggers, but although this topic has been extensively studied, both hemorrhage and seroma are still largely reported [4,5]. Homeopathy could provide remedies based on compounds with anti-hemorrhagic and anti-inflammatory properties . . . .

If you want to cause hemorrhage and inflammation, sure. The authors don’t seem to have glommed onto the Law of Similars properly.

I note that in Table 3, the mean volumes don’t add up to the values listed under “total,” and the placebo values for days 1–4 are not reported to the same number of significant digits as the other entries. I haven’t bothered to subtract off the baseline values to see how they jibe with Fig.&nbsp.1b.

“So this “study”, showing no evidence-based effects, should not have been published based on their results.”

Null results are not published often enough. The problem is rather the pointlessness of the study and the erroneous conclusion, as Orac said. If they’d been honest about it the paper would have at least a tiny bit of redeeming value.

lkrsays:

1000k? — Shirley, you can’t be serious!

And doesn’t this fail the Law of Similars? My impression was that honest-to-god Arnica herbal resins do help with inflammation, not cause it…

So what we’re talking about is one thousand 100-fold serial dilutions, resulting in a final [$10^{-2000}$] dilution.

In addition to the whole Law of Similars problem, they’re quite vague about this. Again, “the residual volume after emptying the flask certainly cannot be >10% of the total used in each dilution.” So it’s Korsakovian, which is usually centesimal, but then throw in the canonical “X” scale decimal-dilution value for good measure.

Hell, they don’t even seem to have succussed the stuff.

dougsays:

Exclusion of participants was about 2.2 times higher in the placebo group.
Would someone who knows about these things comment on whether or not that says anything about randomness of assignment to groups?

@Doug:

I’m someone who knows about these things, and a big difference like that is certainly evidence against randomness of group assignment.

DANIEL GAUTREAUsays:

The latest craze among doctors : ALTERNATIVE Homeopathy : “We found that medicines work much better when we put some active ingredients in them.”…..( from TheSciencePost )

Christine Rosesays:

I don’t think so–the values in question were 3 and 7, so if the expected value is 5 then the Chi-square is a measly 1.6, which is not indicative of funny business.

Eric Lundsays:

The difference in the volume of blood and serum collected by drainages between the group of women treated with A. montana and those treated with placebo was statistically significant in the PP dataset, but only in the model which included, in addition to the type of treatment, the volume collected on the day of surgery, and the weight of the patient. Thus, we determine that these two additional variables have a considerable effect on the efficacy of the treatment, and further studies are needed to investigate their specific contributions.

As long as we are torturing the data until it confesses, may I ask whether the other two variables, independent of which placebo was given, are sufficient to explain the results? Presumably they do not see a significant difference if they only include the variable they are formally testing. That does not in any way imply that, if they add two additional variables, that the variable they are formally testing is the most important of the three, as they are implicitly assuming.

OK, it may not be possible to do this with this kind of data set (unlike with the sorts of data sets I work with). But shouldn’t the referees have flagged this? OK, given the details upthread about the alleged journal that published this study, that’s a rhetorical question.

herr doktor bimlersays:

Thus, we determine that these two additional variables have a considerable effect on the efficacy of the treatment, and further studies are needed to investigate their specific contributions.

That’s some classic statistical-malpractice magical thinking right there. No, “Absence of results when we include confounding factors” does not mean “There is an effect, and the confounding factors are mediating it”. It means, “there is no effect“.

The studied homeopathic treatment and the placebo were manufactured and supplied in strictly identical packaging by Laboratoires Boiron S.r.l.

Truth in labeling?
_______

Alternative explanation: Boiron is selling fake A. montana 1000 K.

After the expected effects failed to appear, the lead researcher sent samples of the placebo and the A. montana, remedy, properly blinded, to Antonietta Gatti and Stefano Montanari, who examined them with their electron miocroscope. Gatti and Montanari found no A. montana nanoparticles in either sample, however they reported a statistically significant higher quotient of nanotoxins in the supposed homeopathic remedy!

How then did the ‘results’ get spun and published? My sources are not at liberty to say, but a franchise agreement with the Genco Olive Oil company appears to have been involved…

Eric Lundsays:

Alternative explanation: Boiron is selling fake A. montana 1000 K.

How would we know the difference? Maybe they’re only doing 500 dilutions, or 200, or whatever. It still would be hundreds of orders of magnitude beyond getting one atom out of the entire observable universe. For that matter, how do we know that Boiron is manufacturing any authentic homeopathic remedies? It’s much cheaper and easier to not bother with the alleged active ingredient in the first place.

BTW, you are testing the edges of Poe’s law here. I had to read your comment twice to realize you were snarking. Had this comment been attached to an unfamiliar ‘nym, or a known troll, I would have assumed that it was trolling.

Alternative explanation: Boiron is selling fake A. montana 1000 K.

I presume that it was not an off-the-shelf product.

For that matter, how do we know that Boiron is manufacturing any authentic homeopathic remedies?

They generate hazardous waste, for one thing. The two annual reports that I have are on the disk I’m trying to rescue, though.

Chris Hickiesays:

Sometimes I see quacks selling “heavy water” (water where a lot of the hydrogen in H20 has been replaced by deuterium) as a medical therapy (unproven, but still marketed as therapeutic–though heavy water does have uses in real scientific research). Unscrupulous homeopaths (this is redundant, I know) should sell homeopathic heavy water. Then the rest of us could sit back with our popcorn and watch the fireworks.

Chris Hickiesays:

@ Dangerous Bacon #26–Dang. Sometimes I almost regret having a sense of right and wrong when I see crooks stealing from other crooks who are both stealing from marks. Gotta love the name for this homeopathic heavy water–Deuterium oxydatum, however, I can’t find what symptoms it’s supposed to treat unless I’m willing to pay 20 bucks for a 6 month membership on openhomeoinfo.org.

Next up on my list: selling homeopathic outer space oxygen to NASA.

@ Eric;

i didn’t want the Godfather reference to be as obvious as “make them an offer they don’t refuse”, but still I’d think olive oil would tip the lack of seriousness, if “fake” homeopathy hadn’t.

Of course, maybe it’s just too hard to imagine anyone in such a pure, safe, natural business as homeopathy coercing (or paying off) fake research to help them make real money on fake bottles of snake-oil fakery. The only people who would sink that low are the toxin-touts of Big Pharma, after all. Not Boiron. Not at all. Never…

Lighthorsesays:

@Narad #23: “They generate hazardous waste, for one thing. The two annual reports that I have are on the disk I’m trying to rescue, though.”

By that I assume you are referring to the waste material from toxic plants they process.

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darkamberdragonsays:

There is of course one possibility for the results of the study.: One or more of the participants were Werewolves and were having and adverse reaction to the Wolfsbane which is a traditional method of killing them. I feel this is a far more plausible reason for the results than any other positive reaction..

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Julian Frostsays: