MD, PhD, FMedSci, FRSB, FRCP, FRCPEd.

Endocrine therapy (ET) is often used to reduce the risk of recurrence in hormone receptor-expressing disease. It is associated with worsening of climacteric symptoms can therefore have a negative impact on the quality of life (QoL) of those affected. Homeopathy is sometimes recommended for management of hot flushes (HF), and a new study aimed to test whether it is effective.

In this multi-centre, double-blind, placebo-controlled RCT, women were included suffering from histologically proven non-metastatic localized breast cancer, with Eastern Cooperative Oncology Group-Performance Status (ECOG-PS) ≤ 1, treated for at least 1 month with adjuvant ET, and complaining about moderate to severe HF. Patients scheduled for chemotherapy, or radiotherapy, or those with associated pathology known to induce HF were excluded. After a 2- to 4-week placebo administration, patients were randomly assigned to receiving the homeopathic medicine complex Actheane® (arm A) or placebo (arm P). Randomization was stratified by adjuvant ET (taxoxifen/aromatase inhibitor) and recruiting site. HF scores (HFS) were calculated as the mean of HF frequencies before randomization, at 4, and at 8 weeks post-randomization (pre-, 4w,- and 8w-) weighted by a 4-level intensity scale. The primary endpoint was the variation between pre- and 4week-HFS. Secondary endpoints included HFS variation between pre- and 8week-HFS. Compliance and tolerance were assessed 8 weeks after randomization, and QoL and satisfaction were assessed at 4- and 8-week post-randomization.

In total, 138 patients were randomized (A, 65; P, 73). Median 4week-HFS absolute variation (A, - 2.9; P, - 2.5 points, p = 0.756) and relative decrease (A, - 17%; P, - 15%, p = 0.629) were not statistically different between the two arms. However, 4week-HFS decreased for 46 (75%) in A vs 48 (68%) patients in P arm. 4week-QoL was stable or improved for respectively 43 (72%) vs 51 (74%) patients (p = 0.470).

The authors concluded that the efficacy endpoint was not reached, and BRN-01 administration was not demonstrated as an efficient treatment to alleviate HF symptoms due to adjuvant ET in breast cancer patients. However, the study drug administration led to decreased HFS with a positive impact on QoL. Without any recommended treatment to treat or alleviate the HF-related disabling symptoms, Actheane® could be a promising option, providing an interesting support for better adherence to ET, thereby reducing the risk of recurrence with a good tolerance profile.

At the start of their abstract, the authors state that homeopathy might allow a better management of hot flushes (HF). Frankly, I fail to see the evidence for this statement. The only study I know of (by a known advocate of homeopathy) showed no effect of homeopathy.

Acthéane is a mixture marketed by Boiron of 5 ingredients:
– Actaea racemosa 4 CH : 0,5 mg
– Arnica montana 4 CH : 0,5 mg
– Glonoinum 4 CH : 0,5 mg
– Lachesis mutus 5 CH : 0,5 mg
– Sanguinaria canadensis 4 CH : 0,5 mg

I am not aware of evidence that this remedy might work.

If there is no plausible rationale for conducting a study, does that not mean it is ethically questionable to do it?

Apart from that, the study seems well-designed. It is not very well presented, but the paper is clear enough. Its results are as one would expect from a rigorous trial of homeopathy. The fact that the authors try to squeeze out some positive messages from this squarely negative study is, of course, pathetic. To mention in the abstract that 4week-HFS decreased for 46 (75%) in A vs 48 (68%) patients (not the primary outcome measure) in P arm is little more than an embarrassing tribute to the sponsor, in my view.

Boiron Canada state on their website that Acteane® is a homeopathic medicine used for the relief of perimenopause and menopause symptoms such as hot flashes, night sweats, sleep disorders, headache, irritability and mood swings.

The benefits of Acteane, a new solution for women:

• Hormone-free
• Soy-free
• Can be associated with other treatments used during perimenopause
• Non-drowsy
• Chewable tablets
• Does not require water

WILL THEY NOW ADD ‘EFFECT-FREE’ TO THEIR LIST?

10 Responses to Another homeopathic product by Boiron has just been shown to be ‘effect-free’

  • A more useful question to be asked is whether or not chewing this overpriced candy promotes tooth decay in people with high levels of oral bacteria. I am surprised that GMO free and gluten free are not on the label.

  • Does not require water

    All the benefits of the magic memory of water without, erm, the water…

  • The benefits …

    This reminds me of the way that sweets are sometimes marketed, with “0% FAT, 0% SALT, 0% ARTIFICIAL COLORING” in huge letters all over the package – and only some very small print on the back reveals that you’re buying 99% sugar and 1% artificial flavoring…

    And oh, slightly off-topic, but still another interesting tidbit about Boiron is their annual financial report. Page 92 and onward reveals that on the income side, there is $614 million in sales, and that their biggest expense is marketing (i.e. lying to the gullible audience that their useless sugar crumbs actually do something), totaling $150 million (~25% of revenues), followed by ‘preparation and distribution costs’ (i.e. getting their useless sugar crumbs to the gullible audience), totaling $ 134 million (~22% of revenues).
    Industrial production expenses comes in third with $125 million, suggesting that at least they actually spend time and effort on the whole dilute-‘n-shake ritual instead of simply selling blank sugar crumbs (as nobody would be able to tell the difference anyway).
    And oh, then there’s ‘Research costs’ of $4 million – a mere 0.65% of their revenue… These laughably tiny ‘research’ expenses don’t exactly jibe with Boiron’s mission statement, mentioning “fundamental and applied research” as one of their corporate purposes. (Also compare this to the ~25% of revenue that Big Pharma spends on R&D…).
    Page 13 explains their ‘research’ in some depth:

    In 2016, BOIRON continued its investigations in the following areas:
    • the highlighting of specific properties of homeopathic medicines and the understanding of their pharmacological actions at different dilution levels and in various living organisms, in areas such as inflammation, the central nervous system or oncology;
    • the comprehension of the physicochemical properties of infinitesimal dilutions;
    • the development of cellular and animal models to evaluate the impact of production and storage processes on the effectiveness of our medicines;
    • the confirmation of the therapeutic value of homeopathy and homeopathic medicines, through the implementation of the most modern investigation methods. Such is the case for the EPI3 study which we conducted with one of the top scientific teams in the field of pharmacoepidemiology. The study lasted for over six years and produced some very satisfactory results concerning the usefulness of our medicines and the ability of doctors to prescribe homeopathic medicines for three groups of the most commonplace pathologies in general medicine: sleep disorders and anxio-depressive symptoms, infections of the upper respiratory tracts and musculo-skeletal pains.

    Now all this sounds hugely interesting, but AFAICS, only the EPI3 study resulted in some peer-reviewed papers – and this study was not carried out or paid for by Boiron itself. So where (and what) are the results of their ‘research’ efforts? Could it be that there aren’t any results, at least none that they would like to see published?

    And oh, about this EPI3 study: it would appear that here too, Boiron was, erm, ‘slightly’ more positive than the researchers themselves, who noted only marginal, non-significant effects that could also be explained through regression to the mean. The same goes for other conditions that were part of this study.
    In fact, the only significant effect consistently found when patients visited homeopaths instead of real doctors was a decreased use of regular pharmaceuticals. Now I wonder … could that be because homeopaths tend to NOT prescribe regular pharmaceuticals? Duh….

  • I wish these unctuous money-launderers would just put six blank-slots under “recommended for…”.
    That way the fool buying the stuff isn’t given any “power of suggestion” on which to base the efficacy they will soon experience. IF any symptoms improve you can fill in the blank!
    If I was to start a homeopathic company (I am considering this as part of my retirement income, along with a scheme to embezzle from the food local pantry….both morally equivalent incomes I’d say) I’d make ONE remedy and put “treats all known and unknown human ailments”. Simple and concise.
    That could be very appealing to Chiropractors since they also think ONE treatment works for all things.
    As I think about it, it sounds suspiciously like every religion. So perhaps I’ll just start a religion and bypass any manufacturing issues.

  • This is one of those ‘low potency’ homeopathic products that contains measurable quantities of ingredients per pill — another example of homeopathy meets herbalism. Presumably if one grinds up a few pills, triturates in ethanol then dilutes to 30C with succussion at each 1:100 step it will lose its ‘effect-free’ status. I wonder why Boiron haven’t already done this.

    • ” Actaea racemosa 4 CH : 0,5 mg”

      Does this mean 1/10^8 of .5 mg of Black Cohosh, .5 mg of Black Cohosh, or maybe 1/10^8 mg of Black Cohosh tincture? That’s, uh, 5 ng.

      Either way it doesn’t seem like a lot of drug. And then there’s the fact that homeopathic doses of Black Cohosh should theoretically make hot flashes worse. This seems to be a best of both worlds; invoking the name of a quack remedy without actually paying for any.

      • @Christine Rose

        You are spot on. Obfuscation is a potent stock-in-trade of homeopathy. Take a look here for a ‘coherent’ account of how to prepare a mother tincture!

        In practice, it seems that nowadays most mother tinctures prepared from plant materials have a concentration of 10 g/100 mL of solvent (usually 95% v:v ethanol) . Like you say, a 10^8 (4CH) dilution of this means there is 5 ng of each ingredient added to a 250 mg pill. This should still amount to a detectable level of at least some of the component molecules with modern, highly sensitive instruments.

  • Endocrine therapy or Hormone therapy drugs such as Femara Use can cause Hot flushes, nausea, Vomiting, Dyspepsia, Dizziness, Headache, and many more side effects.

  • It is merely necessary for them to create walls of obfuscation, and superficially.

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