MD, PhD, FMedSci, FRSB, FRCP, FRCPEd

case report

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Few alternative fads have survived as long as the current Kombucha boom. Since decades, it is being hyped as the best thing since sliced bread. Consequently, it has become popular and is now being promoted as a veritable panacea, allegedly curing asthma, cataracts, diabetes, diarrhoea, gout, herpes, insomnia and rheumatism and purported to shrink the prostate and expand the libido, reverse grey hair, remove wrinkles, relieve haemorrhoids, lower hypertension, prevent cancer, and promote general well-being. Kambucha is believed to stimulate the immune system, and help with HIV infection. And – sure enough – it is ideal for detox!!!

One author goes even further and lists no less than 17 indications:

It’s good for your gut:

1. Kombucha contains naturally fermenting probiotics that help maintain healthy gut flora by increasing the number of beneficial organisms.
2. It preserves nutrients and breaks them down into an easily digestible form, which allows you to absorb them better.
3. It enhances the absorption of minerals, particularly calcium, iron, zinc, magnesium, phosphorous and copper.
4. Healthy gut flora improves digestion, fights candida overgrowth, improves mental clarity and stabilizes moods.
5. A healthy gut can also be attributed to reducing or eliminating depression an anxiety.
6. Kombucha contains numerous strains of yeasts and up to 20 different bacterial species (and possibly many more!).

It detoxifies the body:

7. The enzymes and bacterial acids in kombucha ease the burden on the liver by reducing pancreatic load.
8. Kombucha contains glucuronic acid, which binds to toxins and increases their excretion through the kidney or intestines.
9. In 1951, a popular Russian study found that the daily consumption of kombucha was correlated with an extremely high resistance to cancer.
10. It contains vitamin C, a potent detoxifier.

It supports the nervous system:

11. Kombucha contains vitamin B, which has been associated with reducing blood pressure and supporting the nervous system.

It’s anti-ageing and supports the joints:

12. Kombucha contains glucosamines, which are vital for the treatment and prevention of arthritis.
13. Kombucha allegedly eliminates grey hair, increases sex drive and improves eyesight.
14. Kombucha concentrates the antioxidants found in tea. Antioxidants not only fight the environmental toxins known as free radicals, which contribute to illness and disease, but help slow the aging process.
15. Theoretically, powerful antioxidant nutrients can prevent and lessen wrinkles by promoting skin elasticity.

It’s anti-microbial

16. Kombucha is anti-microbial due to it’s acetic and organic acids, proteins, enzymes and bacteriocins. It exerts anti-microbial activity against pathogenic bacteria like E coli and Salmonella. Incidentally, green tea kombucha has a high anti-microbial effect than when made with black tea.

It decreases sugar cravings

17. Emmet from Remedy told us that customers often comment that kombucha reduces their sugar cravings. “My take on this is that kombucha provides a natural energy boost and is therefore a handy antidote for when cravings kick in. It’s also a great way to break the soft drinks habit.”

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Sadly, none of these claims are based on anything that even vaguely resembles evidence. My own systematic review of 2003 aimed at locating and critically evaluating all human medical investigations of kombucha regardless of study design. However, no clinical studies were found relating to the efficacy of this remedy. Several case reports and case series raise doubts about the safety of kombucha. They include suspected liver damage, metabolic acidosis and cutaneous anthrax infections. One fatality was on record. I therefore concluded that on the basis of these data it was concluded that the largely undetermined benefits do not outweigh the documented risks of kombucha. It can therefore not be recommended for therapeutic use.

Since then no clinical trials have been published; but more information on the risks of Kombucha has emerged. A case report of a 54-year-old asthmatic woman, for instance. She presented to hospital with a 10-day history of breathlessness. On examination, she was tachypnoeic with mild wheeze. She had preserved peak flows and was saturating at 100% on room air. Investigations revealed severe metabolic lactic acidosis. On further questioning, it transpired that she drank kombucha tea, which has been linked to lactic acidosis. She made a full recovery with supportive management and cessation of the tea.

A case of hepatotoxicity has also been related to Kombucha consumption. Another case report tells the story of a 22 year old male, newly diagnosed with HIV, who became short of breath and febrile within twelve hours of Kombucha tea ingestion. He subsequently became combative and confused, requiring sedation and intubation for airway control. Laboratories revealed a lactate of 12.9 mmol/L, and serum creatinine of 2.1 mg/dL. The authors concluded that consumption of this tea should be discouraged, as it may be associated with life-threatening lactic acidosis.

But how can a simple tea like Kombucha cause such serious problems? The answer lies in the method of preparation which carries the risk of contamination: the Kombucha material is incubated at room temperature in a sugar-containing liquid for 7–12 days. It is hardly surprising that, under such conditions, human pathogens may grow. It follows that, depending on the method of preparation and standards of hygiene, some Kombucha teas may be entirely innocent whilst others carry the risk of contamination and infection. Contaminated batches may act like a ‘biological chain letter’.

Considering all this, here are my instructions for making Kombucha and enjoying it safely.

You will need:

  • 3 litres of filtered water
  • 10 green or black teabags
  • 1 SCOBY (symbiotic culture of bacteria and yeast)
  • ½ a cup of sugar

And this is what you need to do:

Boil the filtered water.

Pour over the teabags in a large container.

Add the sugar to the tea, and allow time to brew and cool (about two hours).

Pour the brewed tea into a large, jar and add the SCOBY.

Cover jar with cheesecloth, muslin or paper towel and secure with a rubber band.

Leave to brew for a week or more to taste.

Pour the kombucha into bottles

… and bin the lot.

I have often criticised papers published by chiropractors.

Not today!

This article is excellent and I therefore quote extensively from it.

The objective of this systematic review was to investigate, if there is any evidence that spinal manipulations/chiropractic care can be used in primary prevention (PP) and/or early secondary prevention in diseases other than musculoskeletal conditions. The authors conducted extensive literature searches to locate all studies in this area. Of the 13.099 titles scrutinized, 13 articles were included (8 clinical studies and 5 population studies). They dealt with various disorders of public health importance such as diastolic blood pressure, blood test immunological markers, and mortality. Only two clinical studies could be used for data synthesis. None showed any effect of spinal manipulation/chiropractic treatment.

The authors concluded that they found no evidence in the literature of an effect of chiropractic treatment in the scope of PP or early secondary prevention for disease in general. Chiropractors have to assume their role as evidence-based clinicians and the leaders of the profession must accept that it is harmful to the profession to imply a public health importance in relation to the prevention of such diseases through manipulative therapy/chiropractic treatment.

In addition to this courageous conclusion (the paper is authored by a chiropractor and published in a chiro journal), the authors make the following comments:

Beliefs that a spinal subluxation can cause a multitude of diseases and that its removal can prevent them is clearly at odds with present-day concepts, as the aetiology of most diseases today is considered to be multi-causal, rarely mono-causal. It therefore seems naïve when chiropractors attempt to control the combined effects of environmental, social, biological including genetic as well as noxious lifestyle factors through the simple treatment of the spine. In addition, there is presently no obvious emphasis on the spine and the peripheral nervous system as the governing organ in relation to most pathologies of the human body.

The ‘subluxation model’ can be summarized through several concepts, each with its obvious weakness. According to the first three, (i) disturbances in the spine (frequently called ‘subluxations’) exist and (ii) these can cause a multitude of diseases. (iii) These subluxations can be detected in a chiropractic examination, even before symptoms arise. However, to date, the subluxation has been elusive, as there is no proof for its existence. Statements that there is a causal link between subluxations and various diseases should therefore not be made. The fourth and fifth concepts deal with the treatment, namely (iv) that chiropractic adjustments can remove subluxations, (v) resulting in improved health status. However, even if there were an improvement of a condition following treatment, this does not mean that the underlying theory is correct. In other words, any improvement may or may not be caused by the treatment, and even if so, it does not automatically validate the underlying theory that subluxations cause disease…

Although at first look there appears to be a literature on this subject, it is apparent that most authors lack knowledge in research methodology. The two methodologically acceptable studies in our review were found in PubMed, whereas most of the others were identified in the non-indexed literature. We therefore conclude that it may not be worthwhile in the future to search extensively the non-indexed chiropractic literature for high quality research articles.

One misunderstanding requires some explanations; case reports are usually not considered suitable evidence for effect of treatment, even if the cases relate to patients who ‘recovered’ with treatment. The reasons for this are multiple, such as:

  • Individual cases, usually picked out on the basis of their uniqueness, do not reflect general patterns.
  • Individual successful cases, even if correctly interpreted must be validated in a ‘proper’ research design, which usually means that presumed effect must be tested in a properly powered and designed randomized controlled trial.
  • One or two successful cases may reflect a true but very unusual recovery, and such cases are more likely to be written up and published as clinicians do not take the time to marvel over and spend time on writing and publishing all the other unsuccessful treatment attempts.
  • Recovery may be co-incidental, caused by some other aspect in the patient’s life or it may simply reflect the natural course of the disease, such as natural remission or the regression towards the mean, which in human physiology means that low values tend to increase and high values decrease over time.
  • Cases are usually captured at the end because the results indicate success, meaning that the clinical file has to be reconstructed, because tests were used for clinical reasons and not for research reasons (i.e. recorded by the treating clinician during an ordinary clinical session) and therefore usually not objective and reproducible.
  • The presumed results of the treatment of the disease is communicated from the patient to the treating clinician and not to a third, neutral person and obviously this link is not blinded, so the clinician is both biased in favour of his own treatment and aware of which treatment was given, and so is the patient, which may result in overly positive reporting. The patient wants to please the sympathetic clinician and the clinician is proud of his own work and overestimates the results.
  • The long-term effects are usually not known.
  • Further, and most importantly, there is no control group, so it is impossible to compare the results to an untreated or otherwise treated person or group of persons.

Nevertheless, it is common to see case reports in some research journals and in communities with readers/practitioners without a firmly established research culture it is often considered a good thing to ‘start’ by publishing case reports.

Case reports are useful for other reasons, such as indicating the need for further clinical studies in a specific patient population, describing a clinical presentation or treatment approach, explaining particular procedures, discussing cases, and referring to the evidence behind a clinical process, but they should not be used to make people believe that there is an effect of treatment…

For groups of chiropractors, prevention of disease through chiropractic treatment makes perfect sense, yet the credible literature is void of evidence thereof. Still, the majority of chiropractors practising this way probably believe that there is plenty of evidence in the literature. Clearly, if the chiropractic profession wishes to maintain credibility, it is time seriously to face this issue. Presently, there seems to be no reason why political associations and educational institutions should recommend spinal care to prevent disease in general, unless relevant and acceptable research evidence can be produced to support such activities. In order to be allowed to continue this practice, proper and relevant research is therefore needed…

All chiropractors who want to update their knowledge or to have an evidence-based practice will search new information on the internet. If they are not trained to read the scientific literature, they might trust any article. In this situation, it is logical that the ‘believers’ will choose ‘attractive’ articles and trust the results, without checking the quality of the studies. It is therefore important to educate chiropractors to become relatively competent consumers of research, so they will not assume that every published article is a verity in itself…

END OF QUOTES

YES, YES YES!!!

I am so glad that some experts within the chiropractic community are now publishing statements like these.

This was long overdue.

How was it possible that so many chiropractors so far failed to become competent consumers of research?

Do they and their professional organisations not know that this is deeply unethical?

Actually, I fear they do and did so for a long time.

Why then did they not do anything about it ages ago?

I fear, the answer is as easy as it is disappointing:

If chiropractors systematically trained to become research-competent, the chiropractic profession would cease to exist; they would become a limited version of physiotherapists. There is simply not enough positive evidence to justify chiropractic. In other words, as chiropractic wants to survive, it has little choice other than remaining ignorant of the current best evidence.

I hear this argument so regularly that it might be worth analysing it (yet again) a bit closer.

It is used with the deepest of convictions by proponents of all sorts of quackery who point out that science does not know or explain everything – and certainly not their (very special) therapy. Science is just not sophisticated enough, they say; in fact, a few years ago, it could not even explain how Aspirin works. And just like Aspirin, their very special therapy – let’s call it energy healing (EH) for the sake of this post – does definitely and evidently work. There even is ample proof:

  • Patients get better after using EH, and surely patients don’t lie.
  • Patients pay for EH, and who would pay for something that does not work?
  • EH has survived hundreds of years, and ineffective therapies don’t.
  • EH practitioners have tons of experience and therefore know best.
  • They are respected by very important people and organisations.
  • EH is even reimbursed by some insurance companies.

You have all heard the argument, I’m sure.

How to respond?

The ‘proofs’ listed above are simply fallacies; as such they do not need more detailed discussions, I hope.

But how can we refute the notion that science is not yet sufficiently advanced to explain EH?

The simplest approach might be to explain that science has already tested EH and found it to be ineffective. There really is nothing more to say. And the often-quoted example of Aspirin does clearly not wash. True, a few decades ago, we did not know how it worked. But we always knew that it worked because we conducted clinical trials, and they generated positive results. These findings we the main reasons why scientists wanted to find out how it works, and eventually they did (and even got a Nobel Prize for it). Had the clinical trials not shown effectiveness, nobody would have been interested in alleged mechanisms of action.

With EH, things are different. Rigorous clinical trials of EH have been conducted, and the totality of this evidence fails to show that EH works. Therefore, chasing after a mechanism of action would be silly and wasteful. It’s true, science cannot explain EH, but this is not because it is not yet sophisticated enough; it is because there is nothing to explain. EH has been disproven, and waffling about ‘science is not yet able to explain it’ is either a deliberate lie or a serious delusion.

So far so good. But what if EH had not been submitted to clinical trials?

In such cases, the above line of argument would not work very well.

For instance, as far as I know, there is not a single rigorous clinical trial of crystal healing (CH). Does that mean that perhaps CH-proponents are correct when claiming that it does evidently work and science simply cannot yet understand how?

No, I don’t think so.

Like most of the untested alternative therapies, CH is not based on plausible assumptions. In fact, the implausibility of the underlying assumptions is the reason why such treatments have not and probably never will be submitted to rigorous clinical trials. Why should anyone waste his time and our money running expensive tests on something that is so extremely unlikely? Arguably doing so would even be unethical.

With highly implausible therapies we need no trials, and we do not need to fear that science is not yet sufficiently advance to explain them. In fact, science is sufficiently advanced to be certain that there can be no explanation that is in line with the known laws of nature.

Sadly, some truly deluded fans of CH might still not be satisfied and respond to our reasoning that we need a ‘paradigm shift’. They might say that science cannot explain CH because it is stuck in the straightjacket of an obsolete paradigm which does not cater for phenomena like CH.

Yet this last and desperate attempt of the fanatics is not a logical refuge. Paradigm shifts are not required because some quack thinks so, they are needed only if data have been emerging that cannot possibly be explained within the current paradigm. But this is never the case in alternative medicine. We can explain all the experience of advocates, positive results of researchers and ‘miracle’ cures of patients that are being reported. We know that the experiences are real, but are sure that their explanations of the experience are false. They are not due to the treatment per se but to other phenomena such as placebo effects, natural history, regression towards the mean, spontaneous recovery, etc.

So, whichever way we turn things, and whichever way enthusiasts of alternative therapies twist them, their argument that ‘SCIENCE IS NOT YET ABLE TO EXPLAIN’ is simply wrong.

Today, enthusiasts of homeopathy celebrate the start of the HOMEOPATHY AWARENESS WEEK. Let’s join them by re-addressing one of their favourite themes: their personal experience with homeopathy.

Most homeopathy-fans argue that the negative scientific evidence must be wrong because they have had positive experiences. Whenever I give a lecture, for instance, there will be at least one person in the audience who presents such an experience (and I too could contribute a few such stories from my own past). Such ‘case reports’ can, of course, be interesting, illuminating or leading to further research, but they can never be conclusive.

This concept is often profoundly confusing for patients and consumers. They tend to feel that I am doubting their words, but nothing could be further from the truth. Their experience is certainly true – what might be false is their interpretation of it. I think, I better explain this in more detail using a concrete, published example.

After the publication of our 2003 RCT of homeopathic Arnica which showed that two different potencies have effects that do not differ from those of placebo, I received lots of angry responses from people who told me that they had the opposite experience or observed positive outcomes on their pets. In my subsequent publication in the journal ‘Homeopathy‘ entitled ‘The benefits of Arnica: 16 case reports‘, I have tried my best to explain their experiences in the light of our finding that highly diluted homeopathic Arnica is a placebo:

Sixteen case reports of the apparent benefits of Arnica … raise several relevant points. Firstly, topical Arnica preparations are often wrongly equated with homeopathic Arnica, the subject of our trial. The former are herbal preparations (ie not homeopathically diluted), which have undisputed pharmacological activity. Taken orally they would even be toxic. Thus all Arnica for oral administration must be highly diluted and has therefore no pharmacological effects. The case reports show that many lay people seem to be unclear about the difference between herbal and homeopathic Arnica.

Secondly, if animals seem to respond to homeopathic Arnica, as claimed in several of the case reports, this is not necessarily a proof of its effectiveness. Animals are not immune to placebo effects. Think of Pavlov’s experiments and the fact that conditioning is clearly an element in the placebo response.

Thirdly, the natural history of the condition can mimic clinical improvement caused by therapy. Many of the 16 cases summarized can be explained through a placebo response or the natural history of disease or the combination of both phenomena…

Many of the letters I received were outspoken to say the least. The authors stated that they were ‘appalled’, ‘saddened and angry’ by our research. Others implied that I was paid by the pharmaceutical industry to abolish homeopathy in the UK. One person felt that ‘it is highly irresponsible to dismiss a natural healing remedy with no evidence at all’. I believe the case reports … convey an important message about the power of belief, anecdotes, placebos and expectation.

END OF QUOTE

The thing about case reports and personal experiences is quite simply this: they may seem almost overwhelmingly convincing, but they can NEVER serve as a proof that the treatment in question was effective. The reason for this fact could not be more simple. Any therapeutic response is due to a complex combination of factors: placebo effects, natural history of the condition, regression to the mean, etc.

See it this way: you wake up one morning with an enormous hangover. You try to identify the cause of it. Was it the beer you had in the pub? The wine you drank before you went out? Or the whiskey you consumed before you went to bed? Perhaps you think it was the Cognac you enjoyed at a friend’s house? Only one thing is for sure: it was not the glass of shaken water you drank during the night.

 

Dr. Dietmar Payrhuber is not famous – no, by no means. I had never heard of him until a watched this TV discussion about homeopathy (it’s in German, and well-worth watching, if you understand the language). I found the discussion totally mesmerising: Payrhuber is allowed to come out with case after case alleging he cured cancer of various types with homeopathy. Prof Frass is also there to defend the indefensible, but hardly intervenes, other than repeatedly and pompously stating that he is a professor with 200 publications who runs a homeopathy clinic at the university hospital of Vienna and therefore he is a cut above.

There are also three very bright and eloquent sceptical disputants who do their best to oppose Payrhuber’s moronic monstrosities. One of them even alerts us (and the broadcaster!) to the fact that some cancer patients might watch this and conclude that homeopathy cues cancer. Yes, TV can be dangerous!

After watching Payrhuber, I felt the urge to learn more about this man. On TV, he mentioned repeatedly his publications, so I first of all conducted a Medline search; it turns out that Medline lists not a single article in his name. However, I did find his (self-published) book: ‘HOMOEOPATHIE UND KREBS’ (HOMEOPATHY AND CANCER). It greatly impressed me – but not in a positive sense.

The preface (in English) is by Jan Scholten (who IS quite famous in the realm of homeopathy); here is a short quote from it:

[Payrhuber’s book] … is an important book for several reasons. The first reason is that it shows that homeopathy is a real healing art. Often homeopathy is seen as good for superficial, light and self-healing diseases such as colds, eczema’s, bronchitis and the like. Together with this view goes the opinion that it is not a real medicine, because it cannot treat „real diseases“. But this shows the opposite: cancer can be healed, cured with homeopathy. It shows that homeopathy can have very profound effect and can really cure deeply. Of course cancer was cured already in the past with homeopathy by famous homeopaths such as Grimmer and Resch. But Dietmar shows that it can be done in a consistent way. Homeopathy cannot be set aside as superficial anymore…

But it gets worse! Payrhuber himself is equally clear that homeopathy can cure cancer; here is a quote that I translated from his German text into English:

The book shows options to treat cancer; this is not an exclusive option of homeopathy. However, it offers an alternative for therapy-resistant and slow-responding cases treated conventionally… The question whether homeopathy is an alternative or a complementary therapy is superfluous. As the cases presented here demonstrate, homeopathy is part of medicine, a method which is more scientific than conventional medicine, because it has clear principles and laws. In certain cases or in certain phases of cancer, homeopathy is quite simply indicated! Homeopathy is holistic and puts the whole patient rather than a local symptom in the centre.

We must not keep homeopathy from cancer patients, because it offers in many cases a cure which cannot be achieved by other means.

(For those who can read German, here is the original: Das Buch zeigt Möglichkeiten auf, Krebs zu behandeln, es stellt keinen Alleinanspruch der Homöopathie dar. Es bietet allerdings alternative Möglichkeiten für therapieresistente und therapieträge Behandlungsverläufe bei konventioneller Therapie an…. 

Es erübrigt sich die Frage, ob Homöopathie eine alternative oder komplementäre Medizin ist. Wie die vorliegenden Fälle zeigen, ist sie ein Teil der Medizin, eine Methode, die „eher wissenschaftlicher ist als die Schulmedizin, weil die Homöopathie deutliche Prinzipien und Gesetze hat“. Die Homöopathie ist in bestimmten Fällen oder in bestimmten Phasen der Behandlung schlicht und einfach indiziert! Sie ist ganzheitlich, setzt den Menschen ins Zentrum und nicht das Lokalsymptom…

Die Homöopathie darf dem Patienten nicht vorenthalten werden, da sie in vielen Fällen Heilungsmöglichkeiten bietet, die auf andere Weise nicht erreicht werden können…)

END OF QUOTE

As I said, Payrhuber is not famous – he is infamous!

This sad story left me with three questions:

  1. Can someone please stop Payrhuber before he does more damage to cancer patients?
  2. And can someone please tell the medical faculty of the university of Vienna (my former employer) that running a homeopathy clinic for cancer patients is not ethical?
  3. Can someone please teach journalists that, in healthcare, giving a voice to dangerous nonsense can do serious harm?

Newsweek recently reported that a herbalist has been charged with the death of a 13-year-old diabetic boy. Allegedly, the therapist replaced the boy’s insulin with herbal remedies. Tim Morrow, 83, was charged with

  1. child abuse causing death
  2. and with practicing medicine without a license.

Morrow stated that god had guided him to use herbs rather than conventional medicine and that he successfully treated treat his own prostate cancer in this way. Marrow can be seen on multiple YouTube videos from his ‘University of Common Sense’ promoting his bizarre ideas of health and disease.

Perhaps god also guided Marrow to make lots of money? He runs regular seminars and a thriving herbal on-line business, the ‘Common Sense Herbal Products‘. There are few ailments, for which ‘Common Sense Herbal Products’ do not seem to offer a herbal cure.

One of the remedies, ‘Pancreas Reg‘, for instance, claims to “act as natural insulin”. The 270 Tablets tub of this product costs US $74.22. It is easy to see, I find, how bold claims attract gullible customers depriving them not just of their money but also of their health.

Morrow started treating the boy suffering from Type 1 diabetes after he met his mother at one of his seminars. When the boy subsequently became semi-comatose, Morrow told his parents to treat their son with his herbal remedies rather than insulin which had been prescribed by qualified medical doctors. The boy, Edgar L., died only hours later. There is little doubt that he would have survived, if he had undergone conventional treatment, the medical examiner concluded.

“The allegations in this case underscore the serious health and safety risks of taking medical advice from someone who lacks a license and the proper training that goes with it,” the medical examiner said in a statement. “No family should have to suffer the tragedy of losing a child because of irresponsible, un-credentialed medical advice.”

On this blog, during lectures etc., I often stress that by far the biggest danger of seemingly harmless alternative therapies is that they are used to replace effective treatments for serious conditions. Diabetes is such a condition, and there are numerous instances where the advice of incompetent practitioners has endangered the lives of diabetics.

Three examples will have to suffice as examples of the plethora of such unethical neglect:

  • In homeopathy, diabetes is seen as a reflection of the body’s inability to function optimally. There is an imbalance that results in the body’s incapacity to effectively utilize the insulin that it produces, or to produce sufficient insulin for its needs. While symptoms often disappear after conventional treatment, the vital force does not. Homoeopathy can be used effectively in the treatment of diabetes. Here we mainly concentrate on functioning of the pancreas in efficient insulin production. The metabolic condition of a patient suffering from diabetes requires both therapeutic and nutritional measures to correct the illness. Homeopathy can regulate sugar metabolism while helping to resolve the metabolic disturbances that lead to diabetes. Furthermore, homeopathy helps stimulate the body’s self-healing powers in order to prevent complications such as open leg sores and other dysfunctions of the blood vessel, loss of vision, kidney failure. Homeopathic treatment does not target one illness, an organ, a body part or a symptom. Remedies are prescribed based on an assembly of presenting symptoms, their stresses in life.”
  • Management of Blood sugar. The commonly used remedies are Uranium Nitricum, Phosphoric Acid, Syzygium Jambolanum, Cephalandra Indica etc. These are classical Homeopathic remedies. These are used in physiologically active doses such as Mother tincture, 3x etc. depending up on the level of the blood sugar and the requirement of the patient. Several pharmaceutical companies have also brought in propriety medicines with a combination of the few Homeopathic medicines. Biochemic remedies which is a part of Homeopathy advocates Biocombination No 7 as a specific for Diabetes. Another Biochemic medicine Natrum Phos 3x is widely used with a reasonable success in controlling the blood sugar. Scientific studies on the impact of homeopathic medicines in bringing down blood sugar are limited, but many of the above remedies have some positive effects either as a stand-alone remedy or as an adjunct along with other medications.”
  • Modern medicine has no  permanent cure for diabetes but alternative medicines like yoga ,mudra,ayurveda is very useful to control and even cure diabetes.Ayurveda is an alternative medicine to cure diabetes.”

But these are very rare instances!!!

That’s what apologists usually respond.

Yet, the truth is that NOBODY knows how often such harm occurs.

Why?

There is no monitoring system anywhere that would provide such information.

Rapidly rising in popularity, kratom is hailed by some as a readily available pain remedy that is safer than traditional opioids, an effective addiction withdrawal aid and a pleasurable recreational tonic. But kratom also is assailed as a dangerous and unregulated drug that can be purchased on the Internet, a habit-forming substance that authorities say can result in opioid-like abuse and death.

Last week, the Food and Drug Administration announced that the herbal supplement kratom possesses the properties of an opioid, thus escalating the government’s effort to slow usage of this alternative pain reliever. The FDA states that the number of deaths associated with kratom use has increased to a total of 44, up from a total of 36 since the FDA’s November 2017 report. In the majority of deaths that FDA attributes to kratom, subjects ingested multiple substances with known risks, including alcohol. The presence of multiple drugs makes it difficult to determine the role any one of them played.

So, what is kratom, and why might it be dangerous?

A recent review explains that the leaves of Mitragyna speciosa (commonly known as kratom), a tree endogenous to parts of Southeast Asia, have been used traditionally for their stimulant, mood-elevating, and analgesic effects. The plant’s active constituents, mitragynine and 7-hydroxymitragynine, have been shown to modulate opioid receptors, acting as partial agonists at mu-opioid receptors and competitive antagonists at kappa- and delta-opioid receptors. Both alkaloids are G protein-biased agonists of the mu-opioid receptor and therefore, may induce less respiratory depression than classical opioid agonists. The Mitragyna alkaloids also appear to exert diverse activities at other brain receptors (including adrenergic, serotonergic, and dopaminergic receptors), which may explain the complex pharmacological profile of raw kratom extracts. Kratom exposure alone has not been causally associated with human fatalities to date. However, further research is needed to clarify the complex mechanism of action of the Mitragyna alkaloids and unlock their full therapeutic potential.

Another review adds that, by the early 2000s, kratom was increasingly used in the US as a natural remedy to improve mood and quality of life and as substitutes for prescription and illicit opioids for managing pain and opioid withdrawal by people seeking abstinence from opioids. There has been no documented threat to public health that would appear to warrant emergency scheduling of the products and placement in Schedule I of the CSA carries risks of creating serious public health problems. Banning kratom, risks creating public health problems that do not presently exist.

A third review explains that there are no published human pharmacologic, pharmacokinetic, or drug interaction studies on kratom or mitragynine, making it virtually impossible to fully understand kratom‘s therapeutic potential and risks and the populations most likely to benefit or experience harm from its use. Kratom has been used to ameliorate opioid withdrawal symptoms but also induces withdrawal. Human pharmacologic, pharmacokinetic and clinical data are of low quality precluding any firm conclusions regarding safety and efficacy. Kratom does cause a host of adverse effects without clear guidance for how they should be treated. There are numerous assessments where people have been unable to stop using kratom therapy and withdrawal signs and symptoms are problematic. Kratom does not appear in normal drug screens and, when taken with other substances of abuse, may not be recognized.

A systematic review evaluated all studies on kratom use and mental health published between January 1960 and July 2017. Its findings indicate kratom‘s potential as a harm reduction tool, most notably as a substitute for opioids among people who are addicted. Kratom also enhances mood and relieves anxiety among many users. For many, kratom‘s negative mental health effects – primarily withdrawal symptoms – appear to be mild relative to those of opioids. For some users, however, withdrawal is highly uncomfortable and maintaining abstinence becomes difficult.

In Europe, as of 2011, kratom has become a controlled drug in Denmark, Latvia, Lithuania, Poland, Romania and Sweden. In the UK, since 2016, the sale, import, and export of kratom are prohibited.

On balance, my conclusion is that we urgently need more data and meanwhile should avoid this ‘herbal drug’.

 

You might remember: I have been badly misquoted in an article in THE DAILY TELEGRAPH. Based on a newly published scientific paper, the Telegraph article was about herbal medicines and their potential to interact with synthetic drugs. Towards its end, it cited me stating this:

Emeritus Professor Edzard Ernst, Britain’s first professor of complementary medicine at Exeter University said that doctors should make it clear to patients that they could not be taking herbal remedies alongside drugs.

Prof Ernst said there was no good evidence that they work and that doctors were ‘contributing to disinformation’ by turning a blind eye to the practice.

Not only did this not make any sense (I felt, it made me look like an idiot), but crucially I had never stated this nor had I even commented to a Telegraph journalist about this scientific paper. This was (27/1) when I wrote my blog-post about it.

Several friends persuaded me to file an official complaint – which I somewhat reluctantly did. Subsequently, I received an email from the paper’s ‘editorial compliance executive’ asking me to supply more details about my grievances. I complied with the request by pointing out that:

The following things are wrong with this passage:

1) I never said this.

2) I have not even been interviewed by your journalist and do not know where this quote is supposed to come from.

3) As far as I am aware, I also never stated anything like this anywhere else.

4) It is not and never has been my view that there is no good evidence that herbal remedies can never be combined with drugs.

5) It is not and never has been my opinion that there is no good evidence to suggest that herbal remedies work.

6) It is not and never has been my view that doctors were contributing to disinformation by turning a blind eye to the use of herbal remedies.

The response came swiftly:

The quoted words were recorded at a briefing at the SMC to launch your new book, More Harm than Good? The Moral Maze of Complementary and Alternative Medicine on 17th January 2018. 

We are aware that you have had correspondence with our Science Editor, Sarah Knapton who has since amended the online article to make this clear. 

We do however accept that one sentence was mistakenly attributed to you. We have therefore amended the online article and added a footnote to explain what has been updated.

This was most bizarre, I thought, because I did NOT  have a correspondence with Sarah Knapton, the author of the Telegraph article. On the plus-side, the Telegraph had indeed changed the passage in question; it now read (and did so until yesterday):

Emeritus Professor Edzard Ernst, Britain’s first professor of complementary medicine at Exeter University said there was a ‘potential for harm’.

“It’s a lazy way out of the problem,” he said at a briefing to launch his new book More Harm than Good? The Moral Maze of Complementary and Alternative Medicine. “In medicine you give treatment for a reason and if there is no reason for the homeopathic remedy why should you support it for the placebo treatment.

“As a good doctor you should be able to transmit a placebo effect any case. I just don’t see a reason, I see the potential for harm.” 

The research was published in the British Journal of Clinical Pharmacology.

CORRECTION: This article originally stated that Professor Edzard Ernst said there was no good evidence that herbal remedies work and that doctors were ‘contributing to disinformation’ by turning a blind eye to their usage. In fact, this was not said by Professor Ernst. The article has been amended.

I felt that this was a correction of one mistake by another mistake and pointed out that the briefing had been about homeopathy and NOT about herbal medicine or herb/drug interactions. Therefore I replied to the ‘editorial compliance executive’ insisting on further corrections and pointing out that such an utterly nonsensical comment might harm my reputation as an expert. I also posted a comment under the Telegraph article explainig that homeopathy is not herbal medicine.

Sadly, nothing happened.

So, a few days later, I sent a reminder to the ‘editorial compliance executive’.

And again nothing happened.

… until yesterday.

I had almost given up and was contemplating what to do next, when I received an email. It was not from the  ‘editorial compliance executive’, but from THE TELEGRAPH’s ‘Head of Editorial Compliance’. He wrote that he had listened to the tapes of the original briefing and realised that my comments were indeed made in a different context. Therefore, they had now erased all of the nonsensical stuff and replaced it with this text:

CORRECTION: This article originally stated​ ​that Professor Edzard Ernst​,​ professor of complementary medicine at Exeter Universit​y, ​had said there​ was​ ‘potential for harm’ ​in herbal remedies and ​that doctors were ‘contributing to disinformation’ by turning a blind eye to ​this.​ These comments did not in fact relate to ​interactions between herbal remedies​ and prescribed medication, and they have been removed. We apologise to the Professor for the error.   

I am pleased!

And I gratefully accept the apology.


This might be a long, convoluted and somewhat boring story, but I think it has at least two important elements to it:

  1. It may seem petty to complain, and complain, and send reminders when the complaint seems to be getting ignored (I certainly did not feel sure that I was doing the right thing). But occasionally, it is worth the effort – not because of the personal satisfaction (nice but not essential), but because the truth has a high value which should be respected.
  2. Wondering how all this mess came about, I am asking myself: Does the author of the Telegraph article perhaps genuinely not know the difference between herbal and homeopathic remedies? Obviously, I don’t know the answer to this question, but it would explain the mess she got herself (and me) into. And it would also suggest that it might be necessary to educate journalists about alternative medicine in general and homeopathy in particular (In case there is any interest, I offer to give a few informative lectures with opportunities to ask questions to London-based health writers and science journalists).

Traditional Chinese Medicine (TCM) is popular, not least because it is heavily marketed and thus often perceived as natural and safe. But is this assumption true?

This study analysed  liver tests before and following treatment with herbal Traditional Chinese Medicine (TCM) in order to evaluate the risk of liver injury. Patients with normal values of alanine aminotransferase (ALT) as a diagnostic marker for ruling out pre-existing liver disease were enrolled in a prospective study of a safety program carried out at the First German Hospital of TCM from 1994 to 2015. All patients received herbal products, and their ALT values were reassessed 1-3 d prior to discharge. To evaluate causality for suspected TCM herbs, the Roussel Uclaf Causality Assessment Method (RUCAM) was used.

The report presents data of 21470 patients. ALT ranged from 1 × to < 5 × upper limit normal (ULN) in 844 patients (3.93%) and suggested mild or moderate liver adaptive abnormalities. A total of 26 patients (0.12%) experienced higher ALT values of ≥ 5 × ULN (300.0 ± 172.9 U/L, mean ± SD). Causality for TCM herbs was estimated to be probable in 8/26 patients, possible in 16/26, and excluded in 2/26 cases.

Compared with the large TCM study cohort, patients in the liver injury study cohort were older and contained a higher percentage of women, whereas the duration of the hospital stay was similar in both cohorts. The TCM herbs were rarely applied mostly as mixtures consisting of several herbs adding up to 35 different drugs during the patients’ four-week stay. The daily dosage was 95 ± 30 g and thus slightly higher than in the TCM study cohort. Among the many herbal TCM used by the 26 patients in the liver injury cohort, Bupleuri radix and Scuterllariae radix were the two TCM herbs most frequently implicated in liver injury, with variable RUCAM-based causality gradings. Most of the patients received one to six TCM drugs that were associated with potential liver injury as evidenced from the scientific literature, e.g., one patient (case 8) received six potentially hepatotoxic herbal TCM drugs during their hospital stay.

The authors concluded that in 26 (0.12%) of 21470 patients treated with herbal TCM, liver injury with ALT values of ≥ 5 × ULN was found, which normalized shortly following treatment cessation, also substantiating causality.

In the discussion section of the paper, the authors comment that the use of TCM is widely considered less risky as compared with synthetic drugs, although data on direct comparisons are not available in support of this view. Populations using herbal TCM, drugs, either alone, or combined experience more drug-induced liver injury (DILI) than herb-induced liver injury (HILI), possibly due to a higher use of drugs. Valid data of incidence and prevalence of HILI caused by TCM herbs are lacking, and respective data cannot be derived from the present study.

This study is most valuable, in my view. Its strength is clearly the huge sample size. Top marks for the authors for publishing it!

Having said that, we need to take the incidence figures with a pinch of salt, I think. In reality they could be much higher because:

  • other settings will not be as tightly supervised as the unusual hospital setting;
  • in most other situations the quality of the Chinese herbs might be less controlled;
  • there could be adulteration;
  • there could be contamination.

The ‘elephant in the room’ obviously is the inevitable question about benefit. Like any other treatment, TCM cannot be judged on the basis of its risk but must be evaluated according to its risk/benefit balance. I realise that this was not the subject of the present study, but it is nevertheless crucial: do the benefits of TCM outweigh its risks?

I am not aware that this is the case (but more than willing to consider any sound evidence readers might supply). More importantly, I am not aware of good evidence to show that, for any condition, TCM would be superior in terms of risk/benefit balance than conventional options. This is not a trivial issue: clinicians have the ethical obligation to apply the best (the one with the most positive risk/benefit balance) treatment to their patients.

If I am right, then TCM should not be used in therapeutic routine in or outside hospitals.

If I am right, the ‘First German Hospital of TCM‘ should close asap; it would be violating fundamental ethical principles.

If I am right, the debate about the risks of TCM is almost irrelevant because we simply should not use it.

Or did I misunderstand something here?

What do you think?

 

How often have we heard this? YOU ARE WRONG! MY TREATMENT DOES WORK!!! ONLY THE OTHER DAY, I HAD A PATIENT WHO WAS CURED BY IT.

Take for instance this tweet I got yesterday:

F SThomas‏ @spenthomf

You go too far @EdzardErnst. In fact I was consulted about a child who hadn’t grown after an accident. She responded well to homoeopathy and grew. How much are you being paid for your attempts to deny people’s health choices?

The tweet refers to my last post where I exposed homeopathic child abuse. Having thought about Thomas’ tweet, I must say that I find it too to be abusive – even abusive on 4 different levels.

  1. First, the tweet is obviously a personal attack suggesting that I am bribed into doing what I do. I have stated it many times, and I do so again: I receive no payment from anyone for my work. How then do I survive? I have a pension and savings (not that this is anyone’s business).
  2. Second, it is abusive because it claims that children who suffer from a pathological growth retardation can benefit from homeopathy. There is no evidence for that at all, and making false claims of this nature is unethical and, in this case, even abusive.
  3. Third, if Thomas really did make the observation she suggests in her tweet and is convinced that her homeopathic treatment was the cause of the child’s improvement, she has an ethical duty to do something more about it than just shooting off a flippant tweet. She could, for instance, run a clinical trial to find out whether her observation was correct. I admit this might be beyond her means. So alternatively, she could write up the case in full detail and publish it for all of us to scrutinise her findings. This is the very minimum a responsible clinician ought to do when she comes across a novel and potentially important result. Anything else is my view unethical and hinders progress.

I do, of course, sympathise with lay people who fail to fully understand the concept of causality. But surely, healthcare professionals who pride themselves of taking charge of patients ought to have some comprehension of it. They should know that clinical improvements after a treatment is not necessarily the same as clinical improvement because of the treatment. Is it really too much to ask of them to know the criteria for causality? There is plenty of easy-reading on the subject; even Wikipedia has a good article on it:

In 1965, the English statistician Sir Austin Bradford Hill proposed a set of nine criteria to provide epidemiologic evidence of a causal relationship between a presumed cause and an observed effect. (For example, he demonstrated the connection between cigarette smoking and lung cancer.) The list of the criteria is as follows:

  1. Strength (effect size): A small association does not mean that there is not a causal effect, though the larger the association, the more likely that it is causal.
  2. Consistency (reproducibility): Consistent findings observed by different persons in different places with different samples strengthens the likelihood of an effect.
  3. Specificity: Causation is likely if there is a very specific population at a specific site and disease with no other likely explanation. The more specific an association between a factor and an effect is, the bigger the probability of a causal relationship.
  4. Temporality: The effect has to occur after the cause (and if there is an expected delay between the cause and expected effect, then the effect must occur after that delay).
  5. Biological gradient: Greater exposure should generally lead to greater incidence of the effect. However, in some cases, the mere presence of the factor can trigger the effect. In other cases, an inverse proportion is observed: greater exposure leads to lower incidence.
  6. Plausibility: A plausible mechanism between cause and effect is helpful (but Hill noted that knowledge of the mechanism is limited by current knowledge).
  7. Coherence: Coherence between epidemiological and laboratory findings increases the likelihood of an effect. However, Hill noted that “… lack of such [laboratory] evidence cannot nullify the epidemiological effect on associations”.
  8. Experiment: “Occasionally it is possible to appeal to experimental evidence”.
  9. Analogy: The effect of similar factors may be considered.

And this brings me to my 4th and last level of abuse in relation to the above tweet and most other claims of this nature: being ill-informed and stupid while insisting to make a nonsensical point is, in my view, offensive – so much so that it can reach the level of abuse.

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