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

risk

Prof Harald Walach has had a few rough weeks. First, he published his paper suggesting that Covid vaccinations do more harm than good which was subsequently retracted as flawed, if not fraudulent. Next, he published a paper showing that children are put in danger when wearing face masks suggesting that “decision-makers weigh the hard evidence produced by these experimental measurements accordingly, which suggest that children should not be forced to wear face masks.” Now, the journal put out the following announcement about it:

The Research Letter, “Experimental Assessment of Carbon Dioxide Content in Inhaled Air With or Without Face Masks in Healthy Children: A Randomized Clinical Trial,” by Harald Walach, PhD, and colleagues published online in JAMA Pediatrics on June 30, 2021,1 is hereby retracted.

Following publication, numerous scientific issues were raised regarding the study methodology, including concerns about the applicability of the device used for assessment of carbon dioxide levels in this study setting, and whether the measurements obtained accurately represented carbon dioxide content in inhaled air, as well as issues related to the validity of the study conclusions. In their invited responses to these and other concerns, the authors did not provide sufficiently convincing evidence to resolve these issues, as determined by editorial evaluation and additional scientific review. Given fundamental concerns about the study methodology, uncertainty regarding the validity of the findings and conclusions, and the potential public health implications, the editors have retracted this Research Letter.

To make things even worse, Walach’s University fired him because of his fraudulent anti-vax research. Poznan University of Medical Sciences tweeted on 6 July:

We wish to emphasize that the claims included in dr Harald Walach’s recent article in @Vaccines_MDPI do not represent the position of @PUMS_tweets . We find that the article lacked scientific diligence and proper methodology. Dr. Walach’s affiliation with PUMS was now terminated. Throughout the pandemic PUMS has actively promoted vaccination programs, offering scientific expertise in the media, broadcasting seminars, and reported on progress of the vaccination program. We consider vaccinations as the paramount tool in the global fight against the pandemic. We consider vaccinations as the paramount tool in the global fight against the #pandemic. Over 85% of our own academic community has already been vaccinated with support and encouragement from the University.

As I said, this is truly unlucky …

.. or perhaps not?

Come to think of it, it is lucky when pseudo-science and fraud are called out. It means that the self-cleaning mechanisms of science are working and we are protected from the harm done by charlatans.

Recently, I received this comment from a reader:

Edzard-‘I see you do not understand much of trial design’ is true BUT I wager that you are in the same boat when it comes to a design of a trial for LBP treatment: not only you but many other therapists. There are too many variables in the treatment relationship that would allow genuine , valid criticism of any design. If I have to pick one book of the several listed elsewhere I choose Gregory Grieve’s ‘Common Vertebral Joint Problems’. Get it, read it, think about it and with sufficient luck you may come to realize that your warranted prejudices against many unconventional ‘medical’ treatments should not be of the same strength when it comes to judging the physical therapy of some spinal problems as described in the book.

And a chiro added:

EE: I see that you do not understand much of trial design

Perhaps it’s Ernst who doesnt understand how to research back pain.

“The identification of patient subgroups that respond best to specific interventions has been set as a key priority in LBP research for the past 2 decades.2,7 In parallel, surveys of clinicians managing LBP show that there are strong views against generic treatment and an expectation that treatment should be individualized to the patient.6,22.”

Journal of Orthopaedic & Sports Physical Therapy
Published Online:January 31, 2017Volume47Issue2Pages44-48

Do I need to explain why the Grieve book (yes, I have it and yes, I read it) is not a substitute for evidence that an intervention or technique is effective? No, I didn’t think so. This needs to come from a decent clinical trial.

And how would one design a trial of LBP (low back pain) that would be a meaningful first step and account for the “many variables in the treatment relationship”?

How about proceeding as follows (the steps are not necessarily in that order):

  • Study the previously published literature.
  • Talk to other experts.
  • Recruit a research team that covers all the expertise you need (and don’t have yourself).
  • Formulate your research question. Mine would be IS THERAPY XY MORE EFFECTIVE THAN USUAL CARE FOR CHRONIC LBP? I know LBP is but a vague symptom. This does, however, not necessarily matter (see below).
  • Define primary and secondary outcome measures, e.g. pain, QoL, function, as well as the validated methods with which they will be quantified.
  • Clarify the method you employ for monitoring adverse effects.
  • Do a small pilot study.
  • Involve a statistician.
  • Calculate the required sample size of your study.
  • Consider going multi-center with your trial if you are short of patients.
  • Define chronic LBP as closely as you can. If there is evidence that a certain type of patient responds better to the therapy xy than others, that might be considered in the definition of the type of LBP.
  • List all inclusion and exclusion criteria.
  • Make sure you include randomization in the design.
  • Randomization should be to groups A and B. Group A receives treatment xy, while group B receives usual care.
  • Write down what A and B should and should not entail.
  • Make sure you include blinding of the outcome assessors and data evaluators.
  • Define how frequently the treatments should be administered and for how long.
  • Make sure all therapists employed in the study are of a high standard and define the criteria of this standard.
  • Train all therapists of both groups such that they provide treatments that are as uniform as possible.
  • Work out a reasonable statistical plan for evaluating the results.
  • Write all this down in a protocol.

Such a trial design does not need patient or therapist blinding nor does it require a placebo. The information it would provide is, of course, limited in several ways. Yet it would be a rigorous test of the research question.

If the results of the study are positive, one might consider thinking of an adequate sham treatment to match therapy xy and of other ways of firming up the evidence.

As LBP is not a disease but a symptom, the study does not aim to include patients that all are equal in all aspects of their condition. If some patients turn out to respond better than others, one can later check whether they have identifiable characteristics. Subsequently, one would need to do a trial to test whether the assumption is true.

Therapy xy is complex and needs to be tailored to the characteristics of each patient? That is not necessarily an unsolvable problem. Within limits, it is possible to allow each therapist the freedom to chose the approach he/she thinks is optimal. If the freedom needed is considerable, this might change the research question to something like ‘IS THAT TYPE OF THERAPIST MORE EFFECTIVE THAN THOSE EMPLOYING USUAL CARE FOR CHRONIC LBP?’

My trial would obviously not answer all the open questions. Yet it would be a reasonable start for evaluating a therapy that has not yet been submitted to clinical trials. Subsequent trials could build on its results.

I am sure that I have forgotten lots of details. If they come up in discussion, I can try to incorporate them into the study design.

 

 

Acupuncture is a veritable panacea; it cures everything! At least this is what many of its advocates want us to believe. Does it also have a role in supportive cancer care?

Let’s find out.

This systematic review evaluated the effects of acupuncture in women with breast cancer (BC), focusing on patient-reported outcomes (PROs).

A comprehensive literature search was carried out for randomized controlled trials (RCTs) reporting PROs in BC patients with treatment-related symptoms after undergoing acupuncture for at least four weeks. Literature screening, data extraction, and risk bias assessment were independently carried out by two researchers. The authors stated that they followed the ‘Preferred Reporting Items for Systematic Review and Meta-Analyses’ (PRISMA) guidelines.

Out of the 2, 524 identified studies, 29 studies representing 33 articles were included in this meta-analysis. The RCTs employed various acupuncture techniques with a needle, such as hand-acupuncture and electroacupuncture. Sham/placebo acupuncture, pharmacotherapy, no intervention, or usual care were the control interventions. About half of the studies lacked adequate blinding.

At the end of treatment (EOT), the acupuncture patients’ quality of life (QoL) was measured by the QLQ-C30 QoL subscale, the Functional Assessment of Cancer Therapy-Endocrine Symptoms (FACT-ES), the Functional Assessment of Cancer Therapy–General/Breast (FACT-G/B), and the Menopause-Specific Quality of Life Questionnaire (MENQOL), which depicted a significant improvement. The use of acupuncture in BC patients lead to a considerable reduction in the scores of all subscales of the Brief Pain Inventory-Short Form (BPI-SF) and Visual Analog Scale (VAS) measuring pain. Moreover, patients treated with acupuncture were more likely to experience improvements in hot flashes scores, fatigue, sleep disturbance, and anxiety compared to those in the control group, while the improvements in depression were comparable across both groups. Long-term follow-up results were similar to the EOT results. Eleven RCTs did not report any information on adverse effects.

The authors concluded that current evidence suggests that acupuncture might improve BC treatment-related symptoms measured with PROs including QoL, pain, fatigue, hot flashes, sleep disturbance and anxiety. However, a number of included studies report limited amounts of certain subgroup settings, thus more rigorous, well-designed and larger RCTs are needed to confirm our results.

This review looks rigorous on the surface but has many weaknesses if one digs only a little deeper. To start with, it has no precise research question: is any type of acupuncture better than any type of control? This is not a research question that anyone can answer with just a few studies of mostly poor quality. The authors claim to follow the PRISMA guidelines, yet (as a co-author of these guidelines) I can assure you that this is not true. Many of the included studies are small and lacked blinding. The results are confusing, contradictory and not clearly reported. Many trials fail to mention adverse effects and thus violate research ethics, etc., etc.

The conclusion that acupuncture might improve BC treatment-related symptoms could be true. But does this paper convince me that acupuncture DOES improve these symptoms?

No!

Two chiropractors conducted a retrospective review of publicly available data from the California Board of Chiropractic Examiners. Their aim was to determine categories of offense, experience, and gender of disciplined doctors of chiropractic (DC) in California and compare them with disciplined medical physicians in California.

Retrospective reviews of publicly available data from the California Board of Chiropractic Examiners.

The DC disciplinary categories, in descending order, were

  • fraud (44%),
  • sexual boundary issues (22%),
  • other offences (13%),
  • abuse of alcohol or drugs (10%),
  • negligence or incompetence (6%),
  • poor supervision (2%),
  • mental impairment (.3%).

The authors concluded that the professions differ in the major reasons for disciplinary actions. Two thirds (67%) of the doctors of chiropractic were disciplined for fraud and sexual boundary issues, compared with 59% for negligence and substance misuse for medical physicians. Additional study in each profession may reveal methods to identify causes and possible intervention for those who are at high risk.

The two authors of this paper should be congratulated for their courage to publish such a review. These figures seem shocking. But I think that in reality some of them might be far higher. Take the important matter of competence, for instance. If you consider it competent that chiropractors treat conditions other than back pain, you might arrive at the above-mentioned figure of 6%. If you consider this as incompetent, as I do, the figure might be one order of magnitude higher (for more on unprofessional conduct by chiropractors see here).

The abstract of the paper does not provide comparisons to the data related to the medical profession. Here they are; relative to doctors, chiropractors are:

  • 2x more likely to be involved in malpractice,
  • 9x more likely to be practising fraud,
  • 2x more likely to transgress sexual boundaries.

The frequency of fraud is particularly striking. Come to think of it, however, it is not all that amazing. I have said it before: chiropractic is in my view mostly about money.

It has been reported that B.C.’s chiropractors are deeply divided about the future of their profession, disagreeing on everything from false advertising to the use of routine X-rays.

Chiropractors attending an extraordinary general meeting of the College of Chiropractors of B.C. were split nearly down the middle on a series of non-binding resolutions addressing actions the College has taken in recent years. By the narrowest of margins, with at most 54% support, the members voted in favor of the college’s moves to limit the use of diagnostic X-rays and ban claims that aren’t supported by scientific evidence. The question that remains is who represents the bulk of the profession in B.C. — chiropractors advocating for what they describe as evidence-based practice targeting the musculoskeletal system, or “vitalists” who argue that chiropractic treatment can help with everything from immunity to brain function.

The modernizers see it as “a deliberate attempt to take over the college by a small group of chiropractors with no respect or knowledge of regulation … funded by organizations out of the province and out of the country,” Victoria chiropractor Clark Konczak told the virtual meeting.

At issue was a series of policies the college introduced in the wake of what Konczak called “the smoothie episode.” He was referring to a video posted on Facebook in 2017 by the then-vice chair of the college’s board, Avtar Jassal, in which he falsely suggested fruit smoothies are better than vaccines at preventing the flu.

Earlier this year, the college introduced amendments that bar chiropractors from performing routine and repeat X-rays, saying radiography is only scientifically supported when there are red flags that something is seriously wrong. The policy change on X-rays was the flashpoint in the long-simmering tension within the profession. A group of chiropractors has filed a petition in B.C. Supreme Court, alleging the college is preventing them from providing “safe, ethical, and effective care to their patients.” Their legal action has backing from national and international vitalistic organizations. During the recent meeting, a group of chiropractors argued unsuccessfully for the new X-ray policy to be tossed. Some suggested that chiropractors who don’t perform X-rays as a matter of routine are actually harming their patients. Another extraordinary general meeting has been called for July 20 to vote on resolutions calling for the removal of four college board members.

As I have often pointed out, chiropractic is all about money. The ‘chiro-wars’ have been going on for quite a while now, and they are by no means confined to B. C. or Canada. In a nutshell, they suggest to me that a significant proportion of chiropractors prefer money to progress.

Bernie Garrett is a professor of nursing at the University of British Columbia. He is being mentioned here because he has written a book entitled THE NEW ALCHEMISTS which deals (mostly) with so-called alternative medicine (SCAM). It is a well-written, informative, critical, and evidence-based text that I can recommend wholeheartedly. It will be available in the UK on 29 July but you can pre-order it already.

On Amazon, It is being advertised with the following words:

How to identify and see through deceptive and unethical health marketing practices Health scams come in all shapes and sizes-from the suppression of side-effects from prescription drugs to the unproven benefits of ‘traditional’ health practices-taking advantage of the human tendency to assume good intentions in others. So how do we avoid being deceived? Professor of Nursing, Bernie Garrett explores real-world examples of medical malpractice, pseudo and deceptive health science, dietary and celebrity health fads, deception in alternative medicine and problems with current healthcare regulation, ending with a simple health-scam detection kit. And he looks at how these practices and ineffective regulations affect our lives.

The book is written for the interested layperson. But I am sure that healthcare professionals will like it too, not least because it is fully referenced. Its aim is to inform and prevent consumers from being deceived and exploited by charlatans, an aim shared with this blog – while reading the book, I often got the impression that Bernie Garrett might be a regular reader of my blog.

This does not mean that I did not learn a lot from reading Bernie’s book. On the contrary, there was a lot that I did not know before and that is worth knowing. For instance, were you aware that you can earn a ‘Doctor of Naturopathic Medicine, Advanced Diploma’ or Reiki master qualification for $ 12.99 in a 6-hour online course (if you want to know where you’ll have to get Bernie’s book)?  Well, I didn’t.

Yes, I did enjoy reading this book, and I share Bernie’s views on SCAM. In his overall conclusions, he writes: “The sad truth is, many health fraudsters are highly skilled manipulators, and do not always end up being held to account for their crimes, and many continue to profit from them.” Because this is so, it is good to have another splendid book that will help us in our struggle to inform the public responsibly.

I recently discussed the incredible paper by Walach et al. To remind you, here is its abstract again:

COVID-19 vaccines have had expedited reviews without sufficient safety data. We wanted to compare risks and benefits.

Method: We calculated the number needed to vaccinate (NNTV) from a large Israeli field study to prevent one death. We accessed the Adverse Drug Reactions (ADR) database of the European Medicines Agency and of the Dutch National Register (lareb.nl) to extract the number of cases reporting severe side effects and the number of cases
with fatal side effects.

Result: The NNTV is between 200–700 to prevent one case of COVID-19 for the mRNA vaccine marketed by Pfizer, while the NNTV to prevent one death is between 9000 and 50,000 (95% confidence interval), with 16,000 as a point estimate. The number of cases experiencing adverse reactions has been reported to be 700 per 100,000 vaccinations. Currently, we see 16 serious side effects per 100,000 vaccinations, and the number of fatal side effects is at 4.11/100,000 vaccinations. For three deaths prevented by vaccination we have to accept two inflicted by vaccination.

Conclusions: This lack of clear benefit should cause governments to rethink their vaccination policy.

In my post, I pointed out that the analysis was deeply flawed and its conclusion ridiculous. Many other observers agreed, and several editorial board members of the journal, Vaccines, that unbelievably had published this junk resigned. Yesterday, the journal reacted by retracting the paper. Here is their statement:

The journal retracts the article, The Safety of COVID-19 Vaccinations—We Should Rethink the Policy.

Serious concerns were brought to the attention of the publisher regarding misinterpretation of data, leading to incorrect and distorted conclusions.

The article was evaluated by the Editor-in-Chief with the support of several Editorial Board Members. They found that the article contained several errors that fundamentally affect the interpretation of the findings.

These include, but are not limited to:

The data from the Lareb report (https://www.lareb.nl/coronameldingen) in The Netherlands were used to calculate the number of severe and fatal side effects per 100,000 vaccinations. Unfortunately, in the manuscript by Harald Walach et al. these data were incorrectly interpreted which led to erroneous conclusions. The data was presented as being causally related to adverse events by the authors. This is inaccurate. In The Netherlands, healthcare professionals and patients are invited to report suspicions of adverse events that may be associated with vaccination. For this type of reporting a causal relation between the event and the vaccine is not needed, therefore a reported event that occurred after vaccination is not necessarily attributable to vaccination. Thus, reporting of a death following vaccination does not imply that this is a vaccine-related event. There are several other inaccuracies in the paper by Harald Walach et al. one of which is that fatal cases were certified by medical specialists. It should be known that even this false claim does not imply causation, which the authors imply. Further, the authors have called the events ‘effects’ and ‘reactions’ when this is not established, and until causality is established they are ‘events’ that may or may not be caused by exposure to a vaccine. It does not matter what statistics one may apply, this is incorrect and misleading.

The authors were asked to respond to the claims, but were not able to do so satisfactorily. The authors were notified of the retraction and did not agree.

In my blog post about the paper, I wrote: Let’s hope the journal editor in chief (who failed miserably when publishing this idiocy) has the wisdom to retract it swiftly. I am glad that the retraction has been done quickly. This shows that the important self-cleansing process of science is working.

Two questions still remain to be answered:

  1. Were Walach et al just incompetent or did they wilfully try to mislead us?
  2. How much nonsense is Walach allowed to publish before he is finally stopped?

Boris Johnson has recently bent over backward in order to please the Indian PM, Narendra Mondi. Some even say that a trade agreement between the two countries was achieved at the cost of letting the Delta variant into the UK. Now it seems that political considerations are at the heart of the decision to lend official support to Indian traditional medicine in the UK. The ‘2030 Roadmap for India-UK future relations‘ is a policy document of the UK government. In it, we find that the UK government intends to:

  • Explore cooperation on research into Ayurveda and promote yoga in the UK.
  • Increase opportunities for generic medicine supply from India to the UK by seeking access for Indian pharma products to the NHS and recognition of Indian generic and Ayurvedic medicines that meet UK regulatory standards.

This clearly begs the question, are these plans good or bad for UK public health?

Ayurveda is a system of healthcare developed in India around the mid-first millennium BCE. Ayurvedic medicine involves a range of techniques, including meditation, physical exercises, nutrition, relaxation, massage, and medication. Ayurvedic medicine thrives for balance and claims that the suppression of natural urges leads to illness. Emphasis is placed on moderation. Ayurvedic medicines are extremely varied. They usually are mixtures of multiple ingredients and can consist of plants, animal products, and minerals. They often also contain toxic substances, such as heavy metals which are deliberately added in the ancient belief that they can have positive health effects. The truth, however, is that they can cause serious adverse effects.

Relatively few studies of Ayurvedic remedies exist and most are methodologically weak. A Cochrane review, for instance, concluded that” although there were significant glucose-lowering effects with the use of some herbal mixtures, due to methodological deficiencies and small sample sizes we are unable to draw any definite conclusions regarding their efficacy. Though no significant adverse events were reported, there is insufficient evidence at present to recommend the use of these interventions in routine clinical practice and further studies are needed.”

The efficacy of Ayurvedic remedies obviously depends on the exact nature of the ingredients. Generalizations are therefore problematic. Promising findings exist for a relatively small number of ingredients, including Boswellia, Frankincense, Andrographis paniculata.

Yoga has been defined in several different ways in the various Indian philosophical and religious traditions. From the perspective of alternative medicine, it is a practice of gentle stretching exercises, breathing control, meditation, and lifestyles. The aim is to strengthen prana, the vital force as understood in traditional Indian medicine. Thus, it is claimed to be helpful for most conditions affecting mankind. Most people who practice yoga in the West practise ‘Hatha yoga’, which includes postural exercises (asanas), breath control (pranayama), and meditation (dhyana). It is claimed that these techniques bring an individual to a state of perfect health, stillness, and heightened awareness. Other alleged benefits of regular yoga practice include suppleness, muscular strength, feelings of well-being, reduction of sympathetic drive, pain control, and longevity. Yogic breathing exercises are said to reduce muscular spasms, expand available lung capacity and thus alleviate the symptoms of asthma and other respiratory conditions.

There have been numerous clinical trials of various yoga techniques. They tend to suffer from poor study design and incomplete reporting. Their results are therefore not always reliable. Several systematic reviews have summarised the findings of these studies. An overview included 21 systematic reviews relating to a wide range of conditions. Nine systematic reviews arrived at positive conclusions, but many were associated with a high risk of bias. Unanimously positive evidence emerged only for depression and cardiovascular risk reduction (Ernst E, Lee MS: Focus on Alternative and Complementary Therapies Volume 15(4) December 2010 274–27).

Yoga is generally considered to be safe. However, the only large-scale survey specifically addressing the question of adverse effects found that approximately 30% of yoga class attendees had experienced some type of adverse event. Although the majority had mild symptoms, the survey results indicated that attendees with chronic diseases were more likely to experience adverse events associated with their disease. Therefore, special attention is necessary when yoga is introduced to patients with stress-related, chronic diseases. 

So, should we be pleased about the UK government’s plan to promote Ayurveda and yoga? In view of the mixed and inconclusive evidence, I feel that a cautious approach would be wise. Research into these subjects could be a good idea, particularly if it were aimed at finding out what the exact risks are. Whole-sale integration does, however, not seem prudent at this stage. In other words, let’s find out what generates more good than harm for which conditions and subsequently consider adopting those elements that fulfill this vital criterium.

Prof Harald Walach is well-known to regular readers of this blog (see, for instance, here, here, and here). Those who are aware of his work will know that he is not an expert in infectious diseases, epidemiology, virology, or vaccinations. This did not stop him to publish an analysis that questions the safety and rationale of the current COVID-19 vaccination programs. Here is the abstract:

COVID-19 vaccines have had expedited reviews without sufficient safety data. We wanted to compare risks and benefits.

Method: We calculated the number needed to vaccinate (NNTV) from a large Israeli field study to prevent one death. We accessed the Adverse Drug Reactions (ADR) database of the European Medicines Agency and of the Dutch National Register (lareb.nl) to extract the number of cases reporting severe side effects and the number of cases
with fatal side effects.

Result: The NNTV is between 200–700 to prevent one case of COVID-19 for the mRNA vaccine marketed by Pfizer, while the NNTV to prevent one death is between 9000 and 50,000 (95% confidence interval), with 16,000 as a point estimate. The number of cases experiencing adverse reactions has been reported to be 700 per 100,000 vaccinations. Currently, we see 16 serious side effects per 100,000 vaccinations, and the number of fatal side effects is at 4.11/100,000 vaccinations. For three deaths prevented by vaccination we have to accept two inflicted by vaccination.

Conclusions: This lack of clear benefit should cause governments to rethink their vaccination policy.

I hesitate to comment because some could think that I have a personal grudge, as Walach propagated lies about me. And crucially, like he, I am not a vaccination expert. Yet, I feel I ought to point out that the data that form the basis of Walach’s calculations should not be used in this way for at least two reasons.

  1. Death after vaccination does not mean that this event was caused by the vaccine. For example, if someone had a fatal accident after vaccination, it would count as a vaccine incident according to Walach’s calculation.
  2. Vaccine effectiveness cannot be measured by calculating how many people must receive a vaccine to prevent one case of COVID-19 vaccination. Since vaccines have a protective effect on the community, this would be an outright miscalculation. The more people who receive a vaccine, the fewer people need to receive it to prevent a single case. This situation is the exact opposite of what Walach assumes in his paper.

Conclusion: amongst all his previous nonsense, Walach’s new publication stands out, I feel, as the most stupid and the most dangerous. The mistakes seem too obvious to not be deliberate. Let’s hope the journal editor in chief (who failed miserably when publishing this idiocy) has the wisdom to retract it swiftly. One of its editors already tweeted:

I have resigned from the Editorial Board of

following the publication of this article. It is grossly negligent and I can’t believe it passed peer-review. I hope it will be retracted.

And another ed-board member had this to say:

Some time ago, we published a systematic review of adverse effects of homeopathic remedies. It prompted a spade of angry letters to the editor essentially claiming that homeopathic are so dilute that they cannot possibly cause problems. But they can! And here is another case in point.

It has been reported that, in Germany, several patients suffered from adverse effects such as visual disturbances and dry mouth after taking a homeopathic atropine remedy purchased from a pharmacy.

A 56-year-old man experienced taste and visual disturbances and drowsiness about 15 minutes after taking 30 drops of a homeopathic solution prepared at the pharmacy. Two further patients also experienced increased symptoms of malaise, slurred speech, dry mouth, hypertension, and dizziness after taking the homeopathic product. In each case, the symptoms improved one to two days after discontinuation of intake. In one case, the effects were observed again after repeated intake.

The pharmacy prepared the homeopathic prescriptions on the prescription of a Heilpraktiker. For this purpose, the pharmacy first diluted an Atropinum sulfuricum D4 dilution in a ratio of 1:10. The diluted solution was then added to three other OTC homeopathics. The proportion of the diluted solution was 50 percent (M/M) in each case.

Laboratory analyses found an increased atropine content of up to a factor of 800 in all the solutions tested. It was determined that the pharmacy’s manufacturing process was not the cause of the problem. The steps taken to produce the homeopathic remedy were demonstrably correct.

Eventually, the company that supplied the atropine solution discovered a mix-up: what was declared to be a D4 dilution was in fact the mother tincture of atropine, i.e. undiluted substance. The pharmacist had therefore used the mother tincture instead of the D4 dilution to prepare the formulations.

The story shows that, unsurprisingly, the quality control of homeopathic remedies can be deficient. When this happens, remedies that should contain nothing suddenly contain something. It is, I think, indisputable that this has the potential to harm patients. And this leads me to the conclusions that:

  1. homeopathic remedies are dangerous when they contain nothing because they leave illness untreated;
  2. homeopathic remedies are dangerous when they contain something because they may poison patients.

 

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