pharmacists
It has been reported, at the German Medical Congress (DÄT) a year ago, that it was decided to delete the additional title of homeopathy from the model further training regulations of the German Medical Association. And Federal Health Minister Karl Lauterbach (SPD) tweeted applause: “Homeopathy has no place in modern medicine.”
Now the ‘ Bundesverband der Pharmaziestudierenden in Deutschland’ (BPhD), the German Pharmacists Organization, even goes a few steps further. The position paper distinguishes between evidence-based medicine (EBM) and unproven therapeutic methods. According to the BPhD, these include homeopathy, but also anthroposophy, traditional Chinese medicine, and traditional medicines.
Among other things, the BPhD is disturbed by the way homeopathy presents itself as an alternative, because an alternative means “a choice between two equally suitable possibilities” to achieve a goal, and this is not the case. Compared to evidence-based medicine (EBM), homeopathy is a “constructed, illusory concept” and “the principles of homeopathic teachings and principles” are to be rejected as “unscientific”. According to the BPhD, a designation as “alternative” for advertising purposes should no longer be allowed.
They would also like to see a demarcation from naturopathy; the clear distinction between homeopathy and phytopharmacy has been lacking up to now. The advertising attribute “natural” should therefore also be banned in order to prevent equalization in advertising, the position paper states.
Like doctors, pharmacy students point to the lack of proof of efficacy beyond the placebo effect. According to the BPhD, the dogma WER HEILT HAT RECHT, “he who heals is right” would “disregard all processes that work towards healing and glorify the result”. The “gold standard” of EBM – randomized, double-blind studies with placebo control – should in future also have to be fulfilled by homeopathic medicines, experience reports are not sufficient, it continues.
Homeopathic medicines are only registered as medicinal products without indication, which requires neither proof of efficacy nor clinical studies. The BPhD, therefore, demands that a warning be placed on the preparations that they have “no proven efficacy beyond the placebo effect”. Up to now, without this warning, patients have been “deceived about the efficacy”, and there is an “urgent need for detailed public information and counseling on homeopathy since its unjustified reputation poses a danger of not seeking treatment”. The BPhD also demands that the status of homeopathic medicines is withdrawn and that the pharmacy obligation for the preparations is abolished…
“In the health professions, no trivialization of unproven therapeutic procedures should be tolerated, as inadequate counseling or ignorance poses a danger to patients,” the BPhD said.
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When I first read this article – I translated and shortened it for those who cannot read German- I was truly dazzled. These are the suggestions that I have been making for around 20 years now, not specifically for Germany but for pharmacists in general. For many years, the Germans seemed the least likely to agree with me. But now they seem to be ahead of everyone else in Europe!
How come?
I suspect and hope that our recent initiative might have something to do with it.
Let’s hope that the pharmacists of other countries follow the German example.
I have featured the ‘Münster Circle‘ before. The reason why I do it again today is that we have just published a new Memorandum entitled HOMEOPATHY IN THE PHARMACY. Here is its summary which I translated into English:
Due to questionable regulations in German pharmaceutical law, homeopathic medicines can be given the status of a medicinal product without having to provide valid proof of efficacy. As medicinal products, these preparations may then only be dispensed to customers in pharmacies, which, however, creates an obligation to also supply them on request or prescription. Many pharmacies go far beyond this and advertise homeopathic medicines as a useful therapy option by advertising them prominently in the window. In addition, customers are recommended to use them, corresponding lecture events are supported, and much more. Often, homeopathic preparations are even produced according to pharmacies’ own formulations and marketed under their own name.
For pharmacists and pharmaceutical technical assistants (PTAs) to perform their important task in the proper supply of medicines to the population, they must have successfully completed a scientific study of pharmacy or state-regulated training. This is to ensure that customers are informed and properly advised about their medicines according to the current state of knowledge.
After successfully completing their training or studies, PTAs and pharmacists are undoubtedly able to recognize that homeopathic medicines cannot be effective beyond placebo. They do not have any significant content of active ingredients – if, for example, the high potencies that are considered to be particularly effective still have any active ingredients at all. Consequently, pharmacists and PTAs act against their better knowledge to the detriment of their customers if they create the impression through their actions that homeopathic medicines represent a sensible therapeutic option and customers are thereby encouraged to buy and use them.
Although homeopathics have no potential for direct harm in the absence of relevant amounts of pharmacologically active substances in the preparations, their distribution should nevertheless be viewed critically. The use of homeopathy can mean losing valuable time and delaying the start of effective therapy. It is often accompanied by criticism, even rejection of scientifically oriented medicine and public health, for example when homeopathy is presented as the antithesis to a threatening “pharmaceutical mafia”.
The Münster Circle appeals to pharmacists and PTAs to stop advertising homeopathic medicines as an effective therapeutic option, to stop producing and marketing them themselves, and to advise their customers that homeopathic preparations are not more effective than placebo. The professional organizations of pharmacists and other providers of further training are called upon to no longer offer courses on homeopathy – except for convincingly refuting the often abstruse claims of the supporters.
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I have pointed out for at least 20 years now that pharmacists have an ethical duty toward their clients. And this duty does not involve misleading them and selling them useless homeopathic remedies. On the contrary, it involves advising them on the basis of the best existing evidence.
When I started writing and talking about this, pharmacists seemed quite interested (or perhaps just amused?). They invited me to give lectures, I published an entire series of articles in the PJ, etc. Of late, they seem to be fed up with hearing this message and the invitations have well and truly stopped.
They may be frustrated with my message – but not as frustrated as I am with their inertia. In my view, it is nothing short of a scandal that homeopathic remedies and similarly bogus treatments still feature in pharmacies across the globe.
The U.S. Food and Drug Administration issued warning letters to seven companies for illegally selling dietary supplements that claim to cure, treat, mitigate or prevent cardiovascular disease or related conditions, such as atherosclerosis, stroke or heart failure, in violation of the Federal Food, Drug, and Cosmetic Act (FD&C Act). The FDA is urging consumers not to use these or similar products because they have not been evaluated by the FDA to be safe or effective for their intended use and may be harmful.
The warning letters were issued to:
- Essential Elements (Scale Media Inc.);
- Calroy Health Sciences LLC;
- Iwi;
- BergaMet North America LLC;
- Healthy Trends Worldwide LLC (Golden After 50);
- Chambers’ Apothecary;
- Anabolic Laboratories, LLC.
“Given that cardiovascular disease is the leading cause of death in the U.S., it’s important that the FDA protect the public from products and companies that make unlawful claims to treat it. Dietary supplements that claim to cure, treat, mitigate or prevent cardiovascular disease and related conditions could potentially harm consumers who use these products instead of seeking safe and effective FDA-approved treatments from qualified health care providers,” said Cara Welch, Ph.D., director of the Office of Dietary Supplement Programs in the FDA’s Center for Food Safety and Applied Nutrition. “We encourage consumers to remain vigilant when shopping online or in stores to avoid purchasing products that could put their health at risk.”
Under the FD&C Act, products intended to diagnose, cure, treat, mitigate or prevent disease are drugs and are subject to the requirements that apply to drugs, even if they are labeled as dietary supplements. Unlike drugs approved by the FDA, the agency has not evaluated whether the unapproved products subject to the warning letters announced today are effective for their intended use, what the proper dosage might be, how they could interact with FDA-approved drugs or other substances, or whether they have dangerous side effects or other safety concerns.
The FDA advises consumers to talk to their doctor, pharmacist or other health care provider before deciding to purchase or use any dietary supplement or drug. Some supplements might interact with medicines or other supplements. Health care providers will work with patients to determine which treatment is the best option for their condition.
If a consumer thinks that a product might have caused a reaction or an illness, they should immediately stop using the product and contact their health care provider. The FDA encourages health care providers and consumers to report any adverse reactions associated with FDA-regulated products to the agency using MedWatch or the Safety Reporting Portal.
The FDA has requested responses from the companies within 15 working days stating how they will address the issues described in the warning letters or provide their reasoning and supporting information as to why they think the products are not in violation of the law. Failure to correct violations promptly may result in legal action, including product seizure and/or injunction.
It has been reported that the Regional Court of Dortmund has prohibited the manufacturer of the homeopathic cold remedy Meditonsin from advertising with false health claims. The court did not see sufficient evidence for the advertising claims.
The Consumer Advice Centre (VZ) of North Rhine-Westphalia issued a warning to the Meditonsin manufacturer (MEDICE Arzneimittel Pütter GmbH & Co.) for misleading advertising statements and sued them. The complaint was:
- that the advertising gave the false impression that an improvement in health could be expected with certainty after taking the product,
- that no side effects were to be expected,
- that the product was superior to “chemical-synthetic medicines”.
The Dortmund Regional Court was not convinced by a study referred to by the manufacturer. On its website, the manufacturer of Meditonsin presents the results of a “current, large-scale user study with more than 1,000 patients” under the heading “Proven efficacy & tolerability”. According to a pie chart, 90% of the patients were satisfied or very satisfied with the effect of Meditonsin.
However, according to the VZ, the study was only a “pharmacy-based observational study” with little scientific validity. Despite the lack of evidence, the manufacturer claimed that “the good efficacy and tolerability of Meditonsin® Drops could once again be impressively confirmed”. The Dortmund Regional Court, however, followed the VZ’s statement of grounds for action. “It is not allowed to advertise with statements that give the false impression that a successful treatment can be expected with certainty, as the advertisement for Meditonsin drops suggests,” emphasized Gesa Schölgens, head of “Faktencheck Gesundheitswerbung”, a joint project of the consumer centres of North Rhine-Westphalia and Rhineland-Palatinate. According to the Therapeutic Products Advertising Act, this is prohibited.
The Dortmund Regional Court also found that consumers were misled by the advertising because it gave a false impression that no harmful side effects were to be expected when taking Meditonsin. The package leaflet of the drug listed several side effects. According to this, there could even be an initial worsening of the symptoms after taking the medicine.
According to the VZ, the alleged advantage of the “natural medicinal product” over “many chemical-synthetic medicinal products that only suppress the symptoms”, as presented by the manufacturer, is also inadmissible. This is because it is not permissible to advertise to consumers with claims that the effect is equivalent or superior to that of another medicinal product. This, too, was confirmed by the court.
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In case you like to know more about the remedy, this is from its English language site:
Meditonsin consists of Aconitum, Atropinum Sulfuricum, Mercurius Cyanatus. Active ingredient is the part of the drug or medicine which is biologically active. This portion of the drug is responsible for the main action of the drug which is intended to cure or reduce the symptom or disease.
A review conducted in 2015 reported community pharmacists are willing to adopt a professional role in counselling consumers about the appropriate and safe use of so-called alternative medicine (SCAM) but faced multiple barriers in doing so. This current review aimed to update and extend these findings, by identifying studies published since 2015 that reported on pharmacists across any setting.
Eligible studies published between January 01, 2016, and December 31, 2021, were identified across 6 databases (PubMed, Scopus, Web of Science, EMBASE, ScienceDirect and MEDLINE). A grounded theory approach was used to thematically synthesize the data extracted.
A total of 64studies representing pharmacists across 30 countries were included for review. The study designs varied and included:
- cross-sectional surveys (n = 36),
- qualitative studies (n = 14),
- pseudo-patient studies (n = 3).
Eight studies reported on practice and/or bioethical responsibilities and 19 studies documented factors that would enable pharmacists to fulfill these responsibilities, while 37 studies reported on both.
The authors concluded that these findings indicate research about pharmacists’ responsibilities associated with SCAM is evolving from gap analysis towards research that is proactive in advocating for change in multiple areas. These findings can be used to inform a consensus discussion among pharmacists and key stakeholders regarding a set of professional responsibilities that would serve in the development of: a clearly defined role and associated practice standards, and competency requirements that inform educational learning objectives for inclusion in undergraduate, post-graduate and continuing professional pharmacy education.
I am puzzled why so many researchers in this specific area seem to avoid clearer language plainly stating the essential, simple, and undeniable facts. I am equally puzzled why so few pharmacists speak out.
It is obvious that community pharmacists are firstly healthcare professionals and only secondly shopkeepers. As such, they have important professional and ethical duties. Foremost, they are obliged to inform their customers responsibly – and responsible means telling them about the evidence for or against the SCAM product they are about to purchase. This duty also entails that pharmacists must inform themselves about the best current evidence. In turn, this means they must stop tolerating the current plethora of under- or post-graduate SCAM courses that are not evidence-based.
As we have discussed ad nauseam on this blog, none of this is actually happening (except in very few laudable cases)!
By and large, pharmacists continue to go along with the double standards of a) evidence for conventional drugs and b) fairy tales for SCAM. In the interest of progress, patient safety, and public health, it is time that pharmacists wake up and remind themselves that they are not commercially orientated shopkeepers but ethical healthcare professionals.
The problems for homeopathy in Germany do not seem to stop. Recently, the German health minister announced that he will look at the issue of reimbursement of homeopathy. Now, an article in the Deutsche Apotheker Zeitung (German Journal for Pharmacists) critically discussed the question of the place of homeopathy in German pharmacies. At present, pharmacies are the only places that are allowed to sell homeopathic preparations. This undoubtedly gives them a veneer of respectability; many consumers seem to feel that, if homeopathic preparations are only available in pharmacies, they must be well-tested and effective.
But recently, more and more German pharmacists have been pointing out that homeopathy is ineffective nonsense. A journalist who had listened to the advanced training “Homeopathy Highlights” of the Westphalia-Lippe Chamber of Pharmacists, he subsequently confronted the Chamber with the controversial contents of this advanced training event. The Chamber then declared that it would “no longer offer any refresher seminars on the subject of homeopathy with immediate effect” and that the speaker would also no longer work for it.
And now, the Berlin Chamber of Pharmacists wants the pharmacy community to distance itself from homeopathy as a scientifically recognized and evidence-based drug therapy. With its motion, the Chamber wants to achieve that the title “Naturopathic Medicine and Homeopathy” of the training regulations is replaced by the title “Phytopharmacy and Naturopathy”. The justification states: “The permission to use the title ‘pharmacist for naturopathic treatment and homeopathy’ by the state chambers of pharmacists suggests that homeopathy is a scientifically recognized and evidence-based drug therapy”.
I think it is time that German pharmacists remind themselves that they are more than shopkeepers; they are healthcare professionals who have an ethical duty. I have discussed this issue often enough. If you are interested, here are a few of my posts on this subject:
- Pharmacists must advise customers that homeopathic remedies lack evidence
- “Pharmacists should not sell or dispense homeopathic products”
- German pharmacists fail their customers when advising them on homeopathy
- Pharmacists put themselves at risk by selling homeopathic remedies
- Pro and Contra: should UK community pharmacists sell homeopathic remedies?
- Pharmacists’ responsibilities vis a vis alternative medicine: the violation of healthcare ethics continues.
- It is “disappointing that some pharmacists are still stocking homeopathy products”
- Pharmacists: to sell quackery means you are quacks – or have I got that wrong?
- Pharmacists must use their professional judgement to prevent the supply of homeopathic remedies
It is high time that German pharmacists do the right thing!
About a year ago, I reported last on the situation of homeopathy in France. Now it might be time for another update. The end of the reimbursement of homeopathy was, of course, a heavy blow for the laboratories concerned, especially Boiron and Weleda.
Are these firms now going bust?
Is the French public missing homeopathy?
The cessation of reimbursement took place in two steps: in 2020, the reimbursement rate was reduced to 15 % and expired completely in 2021. The new director of Weleda France, Ludovic Rassat, explains that, in 2020, when the reimbursement was reduced to 15 %, the impact on sales was just 20 %. The decrease was limited because of the supplementary health insurance which 80 % of French people have still supplemented the reimbursement up to 100 %. In 2021, this generosity stopped and the reimbursement fell from 100 to 0 %. This led to a 60 % drop in sales and to losses of 13 million Euros for Weleda France.
According to an Ipsos survey commissioned by Boiron Laboratories in October 2018, 70 % of all French used homeopathy to relieve their first symptoms, 74 % thought homeopathic remedies were effective and 71 % thought homeopathy was a good complement to conventional treatments. One might, therefore, have assumed that French consumers would continue using their beloved remedies despite the cessation of reimbursement. However, this was not the case. The most obvious explanation for this phenomenon, I think, is that the above-mentioned survey had generated false-positive results and that people correctly judged homeopathic remedies to be superfluous.
Faced with unsustainable losses, the French manufacturers of homeopathic products are now forced to react. A press release by Weleda France from 4 July 2022 stated that “This project would result in the discontinuation of pharmaceutical production and medical information in France and the closure of the Weleda division. This would result in the cessation of production activities at the Huningue site and an adjustment of the organisation of activities at headquarters. In total, 127 jobs could be cut at Weleda France.” If this step is taken as planned, Weleda France will have to earn its money purely on its cosmetic and anthroposophical products, according to the director.
In 2019, Laboratoires Boiron owned 4 production laboratories and 28 distribution facilities in France. In March 2020, the company announced that it had decided to cut 646 jobs in France and close 13 of its 31 sites, due to the poor economic results that followed the cessation of reimbursement of its products by the social security system. Following the decision by the Minister of Health, Agnès Buzyn, to stop the reimbursement of homeopathic preparations by the social security system, Boiron announced that the Montrichard site in the Loir-et-Cher region had not managed to find a buyer. As a result, the site, which employed around 80 people, closed on 31 December 2021.
And the French consumers?
Are they missing homeopathy?
Are they suffering from homeopathy withdrawal?
Are they more frequently ill without homeopathy?
Are they switching to more expensive conventional drugs?
I currently spend much of my time in France and cannot say that I have noticed any of this. On the contrary, most people I talk to are delighted that homeopathy is no longer reimbursed. But this is no evidence, of course. I am unable to find any reliable data to answer the above questions.
When the French health minister decided against homeopathy two years ago, she said: “It’s possible to leave the doctor’s office without a prescription! Let’s take advantage of this debate on homeopathy to reflect more broadly on our use of medicine. The ultimate goal is to consume less.” She was correct, it seems.
When I first saw this, I was expecting something like If Homeopathy Beats Science (Mitchell and Webb) – YouTube : videos (reddit.com). But no, “Acute Care Homeopathy for Medical Professionals” is not a masterpiece by gifted satirists. It is much better; it is for real! In fact, it is a collaboration between the “Academy of Homeopathy
Education” (AHE) and the American Institute of Homeopathy (AIH). Together, they published the following announcement:
AHE and AIH are pleased to present a customized educational program designed for busy medical professionals interested in enhancing their practice and expanding the treatment tools available with Homeopathy. Grounded in the original theory and philosophy of Homeopathy, AHE’s quality curriculum empowers practitioners and the material’s inspirational delivery encourages further study towards the mastery of Homeopathy for chronic care.
This course is open to all licensed healthcare providers— medical, osteopathic, naturopathic, dentists, chiropractors, veterinarians, nurse practitioners, nurses, physician assistants, pharmacologists and pharmacists.
Acute-care homeopathy addresses the challenges of 21st-century medical practice.
Among many things, you’ll learn safe and effective ways to manage pain and mitigate antibiotic overuse with FDA-regulated and approved Homeopathic remedies. AHE delivers an integrated learning experience that combines online real-time classroom experiences culminating in a telehealth based clinical internship allowing participants to study from anywhere in the world.
AHE’s team of Homeopathy experts have taught thousands of students around the globe and are known for unparalleled academic rigor, comprehensive clinical training, and robust research initiatives. AHE ensures that every graduate develops the necessary critical thinking skills in homeopathy case taking, analysis, and prescribing to succeed in practice with confidence and competence.
- Smart and savvy tech support team helps to on-board and train even the most reticent digital participants
- Academic support professionals provide an educational safety-net
- Stellar faculty to inspire confidence and encourage students to achieve their best work
- “Fireside Chats,” forums, and social gatherings build community
- Tried and true administrative systems keep things running smoothly so you can focus on learning Homeopathy.
All AHE students receive Radar Opus, the leading software package used by professional homeopaths worldwide.
Upon completion of the didactic program, practitioners begin an Acute Care Internship through AHE and the Homeopathy Help Network’s Acute Care Telehealth Clinic “Homeopathy Help Now” (HHN) which sees thousands of cases each year. Upon successful completion of the internship, practitioners will be invited to participate in ongoing supervised practice through HHN.
AHE is part of a larger vision to shape the future of Homeopathy: HOHM Foundation and the Homeopathy Help NetworkAll clinical services are delivered in an education and research-driven model. HOHM’s Office of Research has multiple peer-reviewed publications focused on education, practice, and clinical outcomes. HOHM is committed to funding Homeopathy study and research at every level.
The Academy of Homeopathy Education (AHE) operates in conjunction with HOHM Foundation, a 501c3 initiative committed to education, advocacy, and access. The Homeopathy Help Network is a telehealth clinic providing fee-for-service chronic care as well as donation-based acute care through Homeopathy Help Now.
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I suspect you simply cannot wait to enroll. To learn more about “Acute Care Homeopathy for Medical Professionals” please fill out the form.
… and don’t forget to pay the fee of US$ 5 500.
No, it’s not expensive, if you think about it. After all, acute-care homeopathy addresses the challenges of 21st-century medical practice.
I was alerted to the following short article from ‘The Blackpool Gazette‘:
Criminals have been using the brand name Pfizer to sell fake homeopathic vaccines to residents, according to police. The white tablets are sold under the pretence that they are an alternative to traditional vaccines, but actually contain no active ingredient. Analysis conducted by Lancashire Police revealed the tablets were nothing more than sugar pills. “Please note Pfizer do not produce any tablets as a cure or prophylactic for COVID-19,” a spokesman for the force added.
Homeopathy is a “treatment” based on the use of highly diluted substances, which practitioners claim can help the body heal itself, according to the NHS. A 2010 House of Commons Science and Technology Committee report on homeopathy said that homeopathic remedies perform no better than placebos. In 2017, NHS England said it would no longer fund homeopathy on the NHS as the lack of any evidence for its effectiveness did not justify the cost. This was backed by a High Court judgement in 2018.
I think there might be a slight misunderstanding here. The homeopathic remedy might not be fake, as it was produced according to the concepts of homeopathy. It is homeopathy itself that is fake. To me, it looks as though we are dealing with the German product I mentioned a while ago. Let me remind you:
Many people believe that homeopathy is essentially plant-based – but they are mistaken! Homeopathic remedies can be made from anything: Berlin wall, X-ray, pus, excrement, dental plaque, mobile phone rays, poisons … anything you can possibly think of. So, why not from vaccines?
This is exactly what a pharmacist specialized in homeopathy thought.
It has been reported that the ‘Schloss-Apotheke’ in Koblenz, Germany offered for sale a homeopathic remedy made from the
Pfizer vaccine. This has since prompted not only the Chamber of Pharmacists but also the Paul Ehrlich Institute and Pfizer to issue statements. On Friday (30/4/2021) morning, the pharmacy had advertised homeopathic remedies based on the Pfizer/Biontech vaccine. The Westphalia-Lippe Chamber of Pharmacists then issued an explicit warning against it. “We are stunned by this,” said a spokesman. The offer has since disappeared from the pharmacy’s website.
On Friday afternoon, the manufacturer of the original vaccine also intervened. The Paul Ehrlich Institute released a statement making it clear that a vaccine is only safe “if it is administered in accordance with the marketing authorization.”
The Schloss-Apotheke had advertised the product in question with the following words:
“We have Pfizer/BioNTech Covid-19-Vaccine in potentized form up to D30 as globules or dilution (for discharge) in stock.”
The chamber of pharmacists countered with a warming under the heading “Facts instead of Fake News” on Facebook and Instagram:
“Whatever they might contain: These remedies are no effective protection against Covid-19.”
Pharmacy manager, Annette Eichele, of the Schloss-Apotheke claimed she had not sold homeopathic Corona vaccines and stressed that effective vaccines of this kind do not exist. According to Eichele, only an additional “mini drop” of the original Biontech vaccine had been used and “highly potentized” and prepared homeopathically. According to Eichele, Corona vaccinations that had already been administered were thus to have a “better and more correct effect with this supplementary product, possibly without causing side effects … but this is not scientifically proven”. The homeopathic product had been produced only on customer request and had been sold less than a dozen times in the past weeks. Ten grams of the remedy were sold for about 15 Euros. On Twitter, Eichele stated: „Wir haben nichts Böses getan, wir wollten nur Menschen helfen!“ (We have done nothing evil, we only wanted to help people). I am reminded yet again of Bert Brecht who observed:
“The opposite of good is not evil but good intentions”.
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If I am right, the remedy is not truly fake but a genuine product of a fake concept, namely homeopathy. In that case, the term ‘criminal’ might need to be applied to homeopathy itself – an interesting thought!
Stress is associated with a multitude of physical and psychological health impairments. To tackle these health disorders, over-the-counter (OTC) products like Neurodoron® are popular since they are considered safe and tolerable. One tablet of this anthroposophic remedy contains the following active ingredients:
- 83.3 mg Aurum metallicum praeparatum trituration (trit.) D10,
- 83.3 mg Kalium phosphoricicum trit. D6,
- 8.3 mg Ferrum-Quarz trit. D2.
Experience reports and first studies indicate that Neurodoron® is efficient in the treatment of stress-associated health symptoms. “To confirm this” (!!!), a non-interventional study (NIS) with pharmacies was conducted.
The NIS was planned to enroll female and male patients who suffered from nervous exhaustion with symptoms caused by acute and/or chronic stress. The main outcome measures were characteristic stress symptoms, stress burden, and perceived stress. Further outcome measures included perceived efficacy and tolerability of the product as assessed by the patients and collection of adverse drug reactions (ADRs). A study duration of about 21 days with a recommended daily dose of 3–4 tablets was set.
In total, 279 patients were enrolled at 74 German pharmacies. The analyzed set (AS) included 272 patients (mean age 44.8 ± 14.4 years, 73.9% female). 175 patients of the AS completed the NIS. During the study, all stress symptoms declined significantly (total score 18.1 vs. 12.1 (of max. 39 points), < 0.0001). Furthermore, a reduction of stress burden (relative difference in stress burden, VAS = −29.1%, < 0.0001) was observed. For most patients, perceived stress was reduced at the study end (PSQ total score decreased in 70.9% of the patients). 75.9% of the study population rated the product efficacy as “good” or “very good” and 96.6% rated its tolerability as “good” or “very good.” One uncritical ADR was reported.
The authors concluded that this study adds information on the beneficial effects of Neurodoron® in self-medication. The results from this NIS showed a marked reduction in stress burden and perceived stress, along with an excellent safety profile of the medicinal product (MP) Neurodoron®. Further trials are required to confirm these results.
I beg to differ!
The study had no control group and therefore one cannot possibly attribute any of the observed changes to the anthroposophic remedy. They are more likely to be due to:
- the natural history of the condition,
- regression towards the mean,
- a placebo effects,
- other treatments administered during the trial period.
Sadly, the authors discuss none of these possibilities in their paper.
In view of this, I am tempted to rephrase their conclusions as follows:
This study adds no valuable information on the effects of Neurodoron® in self-medication. The results from this NIS showed what utter nonsense the Weleda marketing team is capable of producing in an attempt to boost sales.
PS
These declarations of the 4 study authors and the sponsorship are revealing, I thought:
RH and CS are employees of Weleda AG, Germany. JH and KS work for daacro GmbH & Co. KG, a clinical research organization, Germany. The authors declare that there are no conflicts of interest.
This study was financed by the pharmaceutical company Weleda AG, Arlesheim, the employer of RH and CS. Weleda commissioned the CRO daacro for their contribution to the manuscript.
