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

gullible consumer

We have discussed the subject of urine therapy before. And, as I did then, I again apologise for the vulgar title of my post – but it describes urine therapy just perfectly. My new post is based on what I recently found on a website that is entirely devoted to this strange form of treatment:

Around 4 am, workers at the Keeshav Shrusti Go Shaala at Bhayander, in India, head to the tabelas (cow sheds) to collect the first urine of their 230 cows. They collect 200 litres of gomutra (cow urine), which is then sent to a production unit where it is filtered, bottled and then shipped across the country to be sold at high prices.

The popularity of alternative medicine and a back-to-nature rush has meant that those seeking gomutra as the cure for all ailments — it is touted as a cure for cancer, diabetes, high blood pressure, psoriasis among others — has spurred a rise of gomutra products in the Indian market.

A year ago the Indian ‘Council for Scientific and Industrial Research’ even initiated projects to study the anti-cancer and anti-infection properties of various cow products including cow urine and dung. Last September, Maa Gou Products (MGP) approached BigBasket to distribute its range of cow-urine based products, ranging from floor cleaner, tooth powder, balm and face pack.

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Today there are several sites that have been set up specifically to sell cow products. For instance, the one-year-old vendor portal www.gaukranti.org. The site, which retails a range of products, gets 40 per cent of its revenue from cow urine.

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But, not all cow urine bottles are the same or tout the same solutions. Some are used as cleansers; Mumbaikars will recall the Kandivli ccorporator who suggested that KEM Hospital be cleansed daily with cow urine. Some others are meant specifically for weight loss.

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GoArk, for instance, is a weight loss product made by boiling cow urine in an iron pot to which a vapour condensing device is attached. The main difference lies in the source of the cows. Goseva GoArk is prepared from the GIR cow’s urine and GouGanga is from mixed Indian breeds. Bos Indicus, the breed indigenous to the subcontinent, is to be preferred. One expert explains: “foreign breeds such as the Jersey cow have been subjected to genetic modification.” He says that once the gomutra is collected it is filtered around eight times through a piece of cotton cloth. The distillation process, he says, helps ensure that there is no ammonia so that the shelf life is increased. Typically, it’s good to be used up to two years after bottling. The demand for gomutra — whether as a medicine, a face pack or a floor cleanser — is now rising beyond India. There even have been inquiries from the UK, US, Australia and even Arabic countries.

So, watch this space!

 

Guest post by Frank Van der Kooy

Something happened in 2008. Something, or a number of things, triggered an exponential rise in the number of rhinos being killed in South Africa. Poaching numbers remained quite low and was stable for a decade with only 13 being killed in 2007. But then suddenly it jumped to 83 in 2008 and it reached a total of 1 175 in 2015. To explain this will be difficult and it will be due to a number of factors or events coinciding in 2008. One possible contributing factor, which I will discuss here, is the growing acceptance of TCM in western countries! For example: Phynova recently advertised a new product as being the first traditional Chinese medicine (TCM) being registered in the UK. By directing customers to a separate site for more information regarding their product they ‘accidently’ linked to a site which ‘advertised’ rhino horn (this link has since been removed). Another example is a University in Australia who published a thesis in 2008, in which they described the current use of Rhino horn as a highly effective medicine, just like you would describe any other real medicine. Surely this will have an impact!

But first a bit of background, so please bear with me. There are two ‘opposing’ aspects regarding TCM that most members of the public do not seem to understand well. Not their fault, because the TCM lobby groups are spending a huge amount of effort to keep the lines between these two aspects as blurred as possible. The first aspect is the underlying pseudoscientific TCM principles; the yin and yang and the vitalistic “energy” flow through “meridians” and much more. Science has relegated this to the pseudosciences, just like bloodletting, which was seen as a cure-all hundreds of years ago. Unfortunately, the pseudoscientific TCM principles are still with us and based on these principles almost every single TCM modality works! From acupuncture to herbs to animal matter (including rhino horn) – everything is efficacious, safe and cost effective. Evidence for this is that close to a 100% of clinical trials done on TCM in China give positive results. Strange isn’t it! People in China should thus no die of any disease – they have ‘effective’ medicine for everything! This is the world of TCM in a nutshell.

The second aspect of TCM is the application of the modern scientific method to test which of the thousands of TCM modalities are really active, which ones are useless and which ones are dangerous. Decades of investigation have come up empty-handed with one or two exceptions. One notable exception is Artemisia annua which contain a single compound that is highly effective for the treatment of malaria, and once identified and intensely studied, it was taken up into conventional medicine – not the herb, but the compound. If you investigate all the plants in the world you are bound to find some compounds that can be used as medicine – it has nothing to do with TCM principles and it can most definitely not be used as evidence that the TCM principles are correct or that it based on science.

These two aspects are therefore quite different.

In the TCM world just about everything works, but it is not backed up by science. It is huge market ($170 billion) and it creates employment for many – something that make politicians smile. In the modern scientific world, almost nothing in TCM works, but it is based on science. It is however not profitable at all – you have to investigate thousands of plants in order to find one useful compound.

Many TCM practitioners and researchers are avidly trying to combine the positives of these two worlds. They focus mainly on the money and employment aspect of the TCM world and try and combine this with the modern scientific approach. They tend to focus on the one example where modern science discovered a useful compound (artemisinin) in the medicinal plant Artemisia annua, which was also coincidently used as an herb in TCM – as evidence that TCM works! Here are some examples:

“To stigmatise all traditional medicine would be unfair. After all, a Chinese medicine practitioner last year won a Nobel prize.” No, a Chinese scientist using the modern scientific method identified artemisinin after testing hundreds or even thousands of different plants.

This year, Chinese medicine practitioners will be registered in Australia. ….. Chinese herbal medicine is administered routinely in hospitals for many chronic diseases. …… This has led to recognising herbs such as Artemisia as a proven anti-malarial ……” No, the compound artemisinin is a proven anti-malarial!

There has been enormous progress in the last 20 years or so. I am sure you are familiar with the use of one of the Chinese herbs in managing resistant malaria.” No, very little progress and no, the compound artemisinin!

So this is a game that is being played with the simple intention to blur the lines between these two aspects regarding TCM – but the real reason might simply be “A new research-led Chinese medicine clinic in Sydney, better patient outcomes and the potential for Australia to tap into the $170 billion global traditional Chinese medicine market”

Prof Alan Bensoussan the director of the National Institute of Complementary Medicine (NICM) and registered in Australia as a TCM and acupuncture practitioner is a champion in blurring this line. Alan has been instrumental in lobbying the Australian regulatory agency that a long tradition of use is all you need to be able to register new products. He was also influential in establishing the Chinese medicine practitioner registry in Australia, in 2012, and thereby legitimising TCM in Australia. He has been actively chipping away at the resistance that the Australian public have against these pseudoscientific healthcare systems such as TCM – one can argue that he has done so quite successfully because they are expanding their operations into the Westmead precinct of Sydney with a new TCM clinic/hospital.

Enough background; so what does all of this have to do with Rhino horn? (and for that matter other endangered species). We have to remember that in the TCM world just about everything works and that includes rhino horn! Searching Western Sydney University’s theses portal for Xijiao (Chinese for Rhino horn) I found a thesis published in 2008 from the NICM and co-supervised by Alan; “Development of an evidence-based Chinese herbal medicine for the management of vascular dementia”

On page 45-46: “Recently, with fast developing science and technologies being applied in the pharmaceutical manufacturing area, more and more herbs or herbal mixtures have been extracted or made into medicinal injections. These have not only largely facilitated improved application to patients, but also increased the therapeutic effectiveness and accordingly reduced the therapeutic courses …… lists the most common Chinese herbal medicine injections used for the treatment of VaD. “

“Xing Nao Jing Injection (for clearing heat toxin and opening brain, removing phlegm) contains ….. Rhinoceros unicornis (Xijiao), …… Moschus berezovskii (Shexiang), …..”

“…. Xing Nao Jing injection has been widely applied in China for stroke and vascular dementia. …. After 1-month treatment intervention, they found the scores in the treatment group increased remarkably, as compared with the control group …… “

They list two endangered species; the Rhino and the Chinese forest musk deer (Moschus berezovskii). But what is truly worrying is that they don’t even mention the endangered status or at least recommend that the non-endangered substitutes, which do exist in the TCM world, should be used instead – or maybe use fingernails as a substitute? It is not discussed at all. Clearly they are stating that using these endangered animals are way more effective than western medicine (the control group) for the treatment of vascular dementia! This is deplorable to say the least. Statements like this fuels the decimation of this species. But this shows that they truly believe and support the underlying pseudoscientific principles of TCM – they have to, their ability to tap into the TCM market depends on it!

As a scientist you are entitled to discuss historic healthcare treatments such as bloodletting. But make sure to also state that this practice has been shown to be ineffective, and quite dangerous, and that modern science has since come up with many other effective treatments. If it is stated that bloodletting is currently being used and it is effective – then you will simply be promoting bloodletting! The same goes for Rhino horn and this is exactly what they have done here. But then again they live in a world where all TCM modalities are active!

How to solve this problem of growing acceptance of TCM in western countries? A simple step could be that people like Alan publicly denounce the underlying pseudoscientific TCM principles and make the ‘difficult’ switch to real science! Admittedly, he will have to part with lots of money from the CM industry and his Chinese partners, and maybe not built his new TCM hospital! But for some reason I strongly doubt that this will happen. The NICM have successfully applied a very thin, but beautiful, veneer of political correctness and modernity over the surface of complementary medicine. Anyone who cares to look underneath this veneer will find a rotten ancient pseudoscientific TCM world – in this case the promotion and the use of endangered animals.

After reading chapter two of this thesis one cannot believe that this is from an Australian University and paid for by the Australian taxpayer! The main question though: Can I directly link this thesis with the increase in rhino poaching? This will be very difficult if not impossible to do. But that is not the problem. Promoting the pseudoscientific principles of TCM in Australia expands the export market for TCM, and hence will lead to an increased need for raw materials, including the banned Rhino horn. That Rhino horn has been a banned substance since the 1980’s clearly does not seem to have any impact looking at the poaching statistics. In an unrelated paper published in 2010 the ingredients in the Xingnaojing injection is listed as “…. consisting of Chinese herbs such as Moschus, Borneol, Radix Curcumae, Fructus Gardeniae, ….” No full list is given in the paper – dare I say because it contains Rhino horn as well? The drug Ice is also banned, but if you are going to promote it at a ‘trusted’ university, then you shouldn’t be surprised that Ice production increases and more of it flows into Australia – even if it is illegal. The same goes for Rhino horn!

In part one, we have dealt with three common tricks used by quacks to convince the public to consult them and to keep coming back for more. It has been pointed out to me that some of these tricks are used not just by alternative practitioners but also by real physicians. This is, of course, absolutely true. A quack can be defined as “a person who dishonestly claims to have special knowledge and skill in some field, typically medicine.” Therefore real doctors can be real quacks, of course. I happen to have an interest mainly in alternative medicine; that’s why I write about these type of quacks (if it helps keeping you blood pressure within the limits of normal, I can tell you that I occasionally also published about quackery in mainstream medicine, for instance here).

Anyway, now it is time to continue this series of posts by discussing three further common deceptions used by quacks.

A CURE TAKES A LONG TIME

Imagine a scenario where, even after, several therapy sessions, a patient’s condition has not improved. Let’s assume the problem is back pain, and that it has not improved a  bit despite the treatments and the money spent on it. Surely, many patients in such a situation are sooner or later going to give up. They will have had enough! And this is, of course, a serious threat to the practitioner’s cash flow.

Luckily, there is a popular ploy to minimize the risk: the practitioner merely has to explain that the patient’s condition has been going on for a very long time (if, in the above scenario, this were not the case, the practitioner would explain that the pain might be relatively recent but the underlying condition is chronic). This means that a cure will also have to take a very long time – after all, Rome was not built in one day!

This plea to carry on with the ineffective treatments despite any improvement of symptoms is usually not justifiable on medical grounds. It is, however, entirely justifiable on the basis of financial considerations of the practitioners. They rely on their patients’ regular payments and will therefore think of all sorts of means to achieve this aim.

Take my advice and see a clinician who can help you within a reasonable and predictable amount of time.

IT’S DUE TO THE POISONS YOUR DOCTOR GAVE YOU

In the pursuit of a healthy cash-flow, almost all means seem to be allowed – even the fabrication of the bogus notion that the reasons for the patient’s problem were the poisonous drugs prescribed by her doctor who, of course, is in cahoots with BIG PHARMA. Alternative medicine thrives on conspiracy theories, and the one of the evil ‘medical mafia’ is one of the all-time favourites. It enables scrupulous practitioners to instil a good dose of fear into the minds of their patients, a fear that minimises the risk of them returning to real medicine.

My advice is that alternative practitioners who habitually use this or any other conspiracy theory should be avoided at all costs.

THINK HOLISTICALLY

The notion that alternative medicine takes care of the whole person is a most attractive and powerful ploy. Never mind that nothing could be further from being holistic than, for instance, diagnosing conditions by looking at a patient’s iris (iridology), or focussing on her spine (chiropractic, osteopathy), or massaging the soles of her feet (reflexology). And never mind that any type of good conventional medicine is by definition holistic. What counts is the label, and ‘holistic’ is a most desirable one, indeed. Nothing sells quackery better than holism.

Most alternative practitioners call themselves holistic and they rub the holism into the minds of their patients whenever and however they can. This insistence on holism has the added advantage that they have seemingly plausible excuses for their therapeutic failures.

Imagine a patient consulting a practitioner with depression and, even after prolonged treatment, her condition is unchanged. Even in such a situation, the holistic practitioner does not need to despair: he will point out that he never treats diagnostic labels but always the whole person. Therefore, the patient’s depression might not have changed, but surely other issues have improved… and, if the patient introspects a little, she might find that her appetite has improved, that her indigestion is better, or that her tennis elbow is less painful (some things always change given enough time). The holism of quacks may be a false pretence, but its benefits for the practitioner are obvious.

My advice: take holism from quacks with a pinch of salt.

The authors of a recent paper inform us that Reiki is a Japanese system of energy healing that has been used for over 2 500 years. It involves the transfer of energy from the practitioner to the receiver, which promotes healing, and can be done by either contact or non-contact methods. Both the receiver and the practitioner may feel the energy in various forms (warmth, cold, tingling, vibration, pulsations and/or floating sensations). Reiki can also be self-administered if one is a Reiki practitioner. Reiki is mainly used to address stress, anxiety, and pain reduction while also promoting a sense of well-being and improving quality of life.

Such statements should make us weary: what is presented here as fact is nothing more than conjecture – and very, very implausible conjecture too. Anyone who writes stuff like this in the introduction of a scientific paper is, in my view, unlikely to be objective and could be well on the way to present some nasty piece of pseudo-science.

But I am, of course, pre-judging the issue; let’s have a quick look at the article itself.

The purpose of this study was to determine the effects of a 20-week structured self-Reiki program on stress reduction and relaxation in college students. Students were recruited from Stockton University and sessions were conducted in the privacy of their residence. Twenty students completed the entire study consisting of 20 weeks of self-Reiki done twice weekly. Each participant completed a Reiki Baseline Credibility Scale, a Reiki Expectancy Scale, and a Perceived Stress Scale (PSS) after acceptance into the study. The PSS was completed every four weeks once the interventions were initiated. A global assessment questionnaire was completed at the end of the study. Logs summarizing the outcome of each session were submitted at the end of the study.

With the exception of three participants, participants believed that Reiki is a credible technique for reducing stress levels. Except for two participants, participants agreed that Reiki would be effective in reducing stress levels. All participants experienced stress within the month prior to completing the initial PSS. There was a significant reduction in stress levels from pre-study to post-study. There was a correlation between self-rating of improvement and final PSS scores. With one exception, stress levels at 20 weeks did not return to pre-study stress levels.

The authors concluded that this study supports the hypothesis that the calming effect of Reiki may be achieved through the use of self-Reiki.

QED – my suspicions were fully confirmed. This study shows precisely nothing, and it certainly does not support any hypothesis regarding Reiki.

If we recruited 20 volunteers who were sufficiently gullible to believe that watching an ice-cube slowly melting in the kitchen sink, or anything else that we can think of, has profound effects on their vital energy, or chi, or karma, or anything else, we would almost certaily generate similar results.

My conclusion is therefore very different from those of the original authors: THIS STUDY SUPPORTS THE HYPOTHESIS THAT GULLIBLE PEOPLE CAN BE EASILY MISLEAD ABOUT BOGUS THERAPIES WITH PSEUDO-SCIENTIFIC STUDIES BY IRRESPONSIBLE WOULD-BE SCIENTISTS.

Having just finished reading an ‘satirical esothriller’ entitled ‘VIER FRAUEN UND EIN SCHARLATAN’ (it’s a good book but it’s in German, I’m afraid), I have been thinking more than usual about charlatans. A charlatan is defined as a person who falsely pretends to know or be something in order to deceive people. In the book, the charlatan character is deliberately exaggerated as a dishonest, immoral crook. I have met such people; in fact, I have met plenty of such people in alternative medicine. But I have to admit that, in my experience, there are other charlatans too; in particular, I am talking of ‘honest’ quacks who pretend to know while also being utterly convinced to know.

Come to think of the categories of charlatans, I think the matter is really quite simple: as far as I can see, in alternative medicine, there are essentially just two types.

THE CROOK

This type of charlatan is the one we think of first when we mention the term. He (usually it’s a male) has a range of remarkable features:

  • he is dishonest;
  • he is entirely rational;
  • he knows about evidence and has prepared all the necessary pseudo-arguments to belittle science vis a vis his followers;
  • he is only interested in himself;
  • he is immoral;
  • he wants to make money;
  • he employs all the means available to achieve his aims, including PR, advertising, branding, merchandising etc.
  • he does not believe in his ‘message’;
  • he systematically studies and exploits his target group;
  • he does not live by his own rules;
  • when he is implicated in harming a patient, he consults his lawyers;
  • he is cynical;
  • his ‘charisma’, if he has any, is well-studied and extensively rehearsed;
  • when challenged, he sues.

THE FANATCIST

This type is very different from the crook and would be deeply shocked by the crook’s behaviour and attitude. She (often it is a female) can be described as follows:

  • she is convinced to be profoundly honest;
  • she is deluded, often to the point of madness;
  • she ignores the evidence totally and argues that science is just one of several ways of knowing;
  • she feels altruistic;
  • she thinks she is on the moral high ground;
  • she is not primarily out to make money and might even offer her services for free;
  • she does not seek fame;
  • she is religiously convinced of the correctness of her message and wants to save mankind through it;
  • her message is for everyone;
  • she strictly adheres to her own gospel and thinks that those who don’t are traitors;
  • when she is implicated in causing harm, she consults her ueber-guru;
  • she abhors cynicism;
  • her charisma, if she has any, is real and a powerful tool for convincing followers;
  • when challenged, she feels hurt and misunderstood.

As I indicated already, this is a SIMPLE classification. Between the two extremes, there are all shades of grey. In fact, it is a continuous spectrum.

Why should any of this be important?

Charlatans of both types cause immeasurable harm, and it is impossible to decide which type is more dangerous. Our aim must be to prevent or minimise the harm they do. I think, this aim can best be pursued, if we know who we are dealing with. Identifying where precisely on the above scale a particular charlatan or quack is situated, might help in the prevention of harm.

The question why patients turn to homeopathy – or indeed any other disproven treatment – has puzzled many people. There has been a flurry of research into these issues. Here is the abstract of a paper that I find very remarkable and truly fascinating:

Interviews with 100 homeopathic patients in the San Francisco Bay Area show that for the most part the patients are young, white and well-educated, and have white-collar jobs; most had previously tried mainstream medical care and found it unsatisfactory. Among the reasons for their dissatisfaction were instances of negative side effects from medication, lack of nutritional or preventive medical counseling, and lack of health education. Experiences with conventional physicians were almost evenly divided: nearly half of the subjects reported poor experiences, slightly fewer reported good experiences. Three quarters of the patients suffered from chronic illness and about half considered their progress to be good under homeopathic care. The majority were simultaneously involved in other nontraditional health care activities.

If you read the full article, you will see that the authors make further important points:

  • Patients who use alternative treatments are by no means ignorant or unsophisticated.
  • Most of these patients use other treatments in parallel – but they seem to attribute any improvements in their condition to homeopathy.
  • Dissatisfaction with conventional medicine seems the prime motivation to turn to homeopathy. In particular, patients need more time with their clinician and want to share the responsibility for their own health – and these needs are met by homeopaths better than by conventional doctors.
  • Most homeopaths (63%) adhere to Hahnemann’s dictum that homeopathic remedies must never be combined with other treatments. This renders then potentially dangerous in many situations.

At this point you might say BUT WE KNEW ALL THIS BEFORE! True! Why then do I find this paper so remarkable?

It is remarkable mostly because of its publication date: 1978! In fact, it may well be the very first of hundreds of similar surveys that followed in the years since.

The questions I ask myself are these:

  • IF WE KNEW ALL THIS SINCE ALMOST 40 YEARS, WHY HAVE WE NOT DONE MORE ABOUT IT?
  • WHY ARE WE SO UNSUCCESSFUL IN GETTING THE FACTS THROUGH TO OUR PATIENTS?
  • WHY HAVE WE NOT MANAGED TO IMPROVE CONVENTIONAL MEDICINE SUCH THAT PATIENTS STOP CONSULTING QUACKS?
  • WHY ARE WE STILL CONDUCTING SURVEY AFTER SURVEY WHEN THE EMBARRASSING FACTS ARE PLAIN TO SEE?

Conventional cough syrups do not have the best of reputations – but the repute of homeopathic cough syrups is certainly not encouraging. So what should one do with such a preparation? Forget about it? No, one conducts a clinical trial, of course! Not just any old trial but one where science, ethics and common sense are absent. Here are the essentials of a truly innovative study that, I think, has all of these remarkable qualities:

The present prospective observational study investigated children affected by wet acute cough caused by non-complicated URTIs, comparing those who received the homeopathic syrup versus those treated with the homeopathic syrup plus antibiotic. The aims were: 1) to assess whether the addition of antibiotics to a symptomatic treatment had a role in reducing the severity and duration of acute cough in a pediatric population, as well as in improving cough resolution; 2) to verify the safety of the two treatments. Eighty-five children were enrolled in an open study: 46 children received homeopathic syrup alone for 10 days and 39 children received homeopathic syrup for 10 days plus oral antibiotic treatment (amoxicillin/clavulanate, clarithromycin, and erythromycin) for 7 days. To assess cough severity we used a subjective verbal category-descriptive (VCD) scale. Cough VCD score was significantly (P < 0.001) reduced in both groups starting from the second day of treatment (−0.52 ± 0.66 in the homeopathic syrup group and −0.56 ± 0.55 in children receiving homeopathic syrup plus oral antibiotic treatment). No significant differences in cough severity or resolution were found between the two groups of children in any of the 28 days of the study. After the first week (day 8) cough was completely resolved in more than one-half of patients in both groups. Two children (4.3 %) reported adverse effects in the group treated with the homeopathic syrup alone, versus 9 children (23.1 %) in the group treated with the homeopathic syrup plus antibiotics (P = 0.020).

Conclusions

Our data confirm that the homeopathic treatment in question has potential benefits for cough in children as well, and highlight the strong safety profile of this treatment. Additional antibiotic prescription was not associated with a greater cough reduction, and presented more adverse events than the homeopathic syrup alone.

Let us be clear about what has happened here. I think, the events can be summarised as follows:

  • the researchers come across a homeopathic syrup (anyone who understands respiratory problems and/or therapeutics would be more than a little suspicious of this product, but this team is exceptional),
  • they decide to do a trial with it (a decision which would make some ethicists already quite nervous, but the ethics committee is exceptional too),
  • the question raises, what should the researchers give to the control group?
  • someone has the idea, why not compare our dodgy syrup against something that is equally dodgy, perhaps even a bit unsafe?
  • the researchers are impressed and ask: but what precisely could we use?
  • let’s take antibiotics; they are often used for acute coughs, but the best evidence fails to show that they are helpful and they have, of course, risks,
  • another member of the team adds: let’s use children, they and their mothers are unlikely to understand what we are up to,
  • the team is in agreement,
  • Boiron, the world’s largest producer of homeopathic products, accepts to finance the study,
  • a protocol is written,
  • ethics approval is obtained,
  • the trial is conducted and even published by a journal with the help of peer-reviewers who are less than critical.

And the results of the trial? Contrary to the authors’ conclusion copied above, they show that two bogus treatments are worse that one.

BOB’S YOUR UNCLE!

EVERYONE SEEMS HAPPY: THE RESEARCHERS CAN ADD AN ARTICLE TO THEIR PUBLICATION LIST, BOIRON HAS MORE ‘EVIDENCE’ IN FAVOUR OF HOMEOPATHY, AND THE ETHICS COMMITTEE SLEEP JUST AS SOUNDLY AS THE PEER-REVIEWERS.

Would you believe it? This is the 500th post on this blog!

When I started this blog less than three years ago, I would have never thought that I would have fun doing this; and I would not have expected to get hooked on it. In fact, it needed even a bit of arm twisting to try it, and I have to thank Alan for doing it and everything else. Without him, this blog would surely not exist.

With my very first post, I promised that my blog is not going to provide just another critique of alternative medicine; it is going to be different, I hope. The reasons for this are fairly obvious: I have researched alternative medicine for two decades. My team and I have conducted about 40 clinical trials and published more than 100 systematic reviews of alternative medicine. We were by far the most productive research unit in this area. For 14 years, we hosted an annual international conference for researchers in this field. I know many of the leading investigators personally, and I understand their way of thinking. I have rehearsed every possible argument for or against alternative medicine dozens of times.

In a nutshell, I am not someone who judges alternative medicine from the outside; I come from within the field. Arguably, I am the only researcher in this area who is willing [or capable?] to state publicly what is wrong with alternative medicine. This is perhaps one of the advantages of being an emeritus professor!

I am not sure whether I lived up to this promise – but I did try. And one thing is for sure, it was an eventful exercise. The blog now has ~ 20 000 readers every week; we had something like 15 000 comments; and some posts were re-tweeted several hundred times.

This seems to indicate that there is a need for a forum of this nature. Alternative medicine continues to be popular but critical thinking is not something that this field is blessed with. On the contrary, the misinformation on this subject is simply monstrous and seems to be growing every day. Factual and reliable information is very hard to come by, and therefore I feel that I am doing an important educational job here.

It’s a job which I certainly could not do alone. I therefore like to take this occasion to thank everyone who made my blog what it is today. Alan has already been mentioned but the many commentators deserve a big THANKS too – regardless of whether I agree or disagree with you, your comments make it all worth my while.

Lyme disease, also known as Lyme borreliosis, is an infectious disease caused by Borrelia infection transmitted by ticks. The most common early sign is an expanding area of redness beginning at the site of a bite about a week after a tick-bite. Fever, tiredness and headaches often follow. Later stages are characterised by more severe and remarkably variable illness.

Patients with medically unexplained or vague symptoms are sometimes told that they suffer from Lyme disease. These patients are commonly targeted by providers of alternative therapies who promise hope by claiming that their particular brand of quackery is effective for this chronic condition.

A recent review was designed to identify and characterize the range of unorthodox alternative therapies advertised to patients with a diagnosis of Lyme disease.

Internet searches using the Google search engine were performed to identify the websites of clinics and services that marketed non-antimicrobial therapies for Lyme disease. Subsequently the PubMed search engine was employed to identify any scientific studies evaluating such treatments for Lyme disease. Websites were included in this review, if they advertised a commercial, non-antimicrobial product or service that specifically mentioned utility for Lyme disease. Websites with patient testimonials (such as discussion groups) were excluded unless the testimonial appeared as marketing on a commercial site.

More than 30 different alternative treatments were identified. They fell into several broad categories: these included oxygen and reactive oxygen therapy; energy and radiation-based therapies; nutritional therapies; chelation and heavy metal therapies; and biological and pharmacological therapies ranging from certain medications without recognized therapeutic effects on Borrelia burgdorgeri to stem cell transplantation. The review of the medical literature did not substantiate efficacy or, in most cases, any rationale for the advertised treatments.

The authors concluded that providers of alternative therapies commonly target patients who believe they have Lyme disease. The efficacy of these unconventional treatments for Lyme disease is not supported by scientific evidence, and in many cases they are potentially harmful.

Being a bacterial infection, Lyme disease can be successfully treated with oral or intra-venous antibiotics. But, of course, patients need to have the infection in order to benefit from antibiotic treatment. Those patients who don’t are easy targets for charlatans promising help from bogus treatments. It seems that an entire, profitable industry has developed around this situation.

According to Bloomberg Markets, A Nelson & Co Ltd. manufactures and markets natural healthcare products. The company offers arnica creams that provide natural first aid for bruises; plant and flower based remedies that help in managing the emotional demands of everyday life; and over-the-counter homeopathic medicines for everyday ailments, such as relief from travel sickness and relief for the symptoms of hay fever. It also provides hemorrhoid relief creams and soothing hygienic wipes; anti-blemish range products for various skin types and age groups; multi-purpose cream that helps to soothe and restore skin; iron supplements; teething granules that provide relief from the symptoms and discomfort of teething; a range of creams, ointments, and sprays for a range of common skin conditions/complaints; and a range of commonly used herbal remedies. The company offers products for ailments, including aches and pains, mild anxiety, babies and children, colds and minor infections, digestion, emotional health, energy, everyday stresses, first aid, getting older, pets, quit smoking, skin, sleep, travel, and women’s health. It also operates a clinic; and a pharmacy that offers homeopathy and complementary healthcare products. The company offers its products through its pharmacy in the United Kingdom; and distributors in Europe, Latin America, and internationally. It also serves customers online. The company was formerly known as Armbrecht, Nelson & Co. The company was founded in 1860 and is based in London, United Kingdom with subsidiary offices in Boston, Massachusetts; and Hamburg, Germany. A Nelson & Co Ltd. operates as a subsidiary of Nelson and Russell Holdings Ltd.

In the journal ‘Chemist and Druggist’ we find an article informing us that, in 1930, Nelsons Homeopathic Pharmacy was approached by Dr Edward Bach who wanted help making and selling his products. He had created 38 flower remedies to rebalance emotions and later created an emergency remedy, a combination of five flower remedies that became Rescue. The relationship between Nelsons and the Dr Edward Bach Centre, based at Dr Bach’s former home at Mount Vernon in Oxfordshire, continues to this day and both the Bach Original Flower Remedies and Rescue are key ranges for Nelsons.

Nelson’s homeopathic pharmacy has a proud history:

Ernst Louis Armbrecht, a German pharmacist and disciple of Samuel Hahnemann, came to London and founded Nelsonsin 1860. Since then, Nelsons has been supplying homeopathic medicines. “Our wish today” they state “is the same as 152 years ago: to make homeopathy accessible and to provide the highest standards of medicine and advice.”

The highest standards of medicine and advice? It seems that the Advertising Standards Authority (ASA) disagrees. A recent ASA Adjudication on A Nelson & Co Ltd deals with an advertisement by Nelsons for ‘Bach Rescue Night’ which stated “I CAN’T SWITCH OFF…The RESCUE NIGHT range helps your mind switch off, so you can enjoy a natural night’s sleep”

A freelance health writer had challenged whether the claims “I can’t switch off … Rescue Night range helps your mind switch off, so you can enjoy a natural night’s sleep” was an authorised health claim in the EU Register of Nutrition and Health Claims for Foods (the EU Register).

The ASA noted that, according to EC Regulation 1924/2006 on Nutrition and Health Claims made on Foods (the Regulation), which was reflected in the CAP Code, only health claims which appeared on the list of authorised health claims (the Register) could be made in ads promoting foods, including food supplements. Health claims were defined as those that stated, suggested or implied that a relationship existed between a food category, a food or one of its constituents and health.

The ASA furthermore stated: We acknowledged Rescue Remedy’s assertion that their ad had not made specific claims to aid sleep or that it improved sleep. However, we considered that the use of visuals such as a crescent moon and stars on a dark background, that the letter ‘O’ in the word “OFF” resembled a simple on/ off light switch image, the text “… you can enjoy a natural night’s sleep” and the name of the product “Rescue Night” was likely to give the impression to consumers that it was a product that would aid sleep or that it would help consumers fall asleep easily. We understood that ‘unwanted thoughts’ was one reason why consumers might find it difficult to get to sleep and, again, considered this added to the impression that the product would contribute positively to sleep. We therefore considered that the ad made a health claim related to sleep involving a food item.

We understood that some Bach Flower Remedies contained levels of alcohol which would preclude them from bearing health claims altogether, however, we noted that Bach Rescue Night was alcohol free. We acknowledged Rescue Remedy’s points regarding EFSA and ‘on hold’ claims for botanicals. We understood that ‘on hold’ claims for such botanicals could be used in marketing, provided such use had the same meaning as the proposed claim and they were used in compliance with applicable existing national provisions (in this case the CAP Code). However, Rescue Remedy did not provide evidence that relevant proposed claims for white chestnut, or any of the other product ingredients were ‘on hold’. Nevertheless, we understood that there were no ‘on hold’ claims entered onto the Register for white chestnut or the other product ingredients. Furthermore, ‘on hold’ claims should also be supported with adequate substantiation which we did not receive.

Because the ad made health claims relating to Bach Rescue Night as a sleep aid and we had not seen evidence that relevant claims for the botanical ingredients contained in the product were ‘on hold’, we concluded that the ad breached the Code.

The ad breached CAP Code (Edition 12) rules 15.1, 15.1.1 and 15.7 (Food, food supplements and associated health or nutritional claims).

The ASA ruled that the ad must not appear again in its current form. We told A Nelson & Co Ltd t/a rescueremedy.co.uk not to make health claims for botanical ingredients if they did not comply with the requirements of the Regulation.

I am afraid that such a ruling will have very little effect on the sale of Bach Flower Remedies. In case you have any doubt, I should mention that these inventions of Dr Bach are not supported by good evidence. Here is the abstract of my systematic review on the subject:

Bach flower remedies continue to be popular and its proponents make a range of medicinal claims for them. The aim of this systematic review was to critically evaluate the evidence for these claims. Five electronic databases were searched without restrictions on time or language. All randomised clinical trials of flower remedies were included. Seven such studies were located. All but one were placebo-controlled. All placebo-controlled trials failed to demonstrate efficacy. It is concluded that the most reliable clinical trials do not show any differences between flower remedies and placebos.

Bach Flower Remedies have no effect whatsoever!

Come to think of it, this is not entirely true: they obviously keep the ASA busy, they exploit the gullible public, and they are clearly good for the cash flow at Nelson’s.

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