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

naturopathy

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Homeopathy has had its fair share of declarations, and now there is another one. I find this new one important because it is from German medical students and might thus indicate where German homeopathy is heading.

The ‘Bundesvertretung der Medizinstudenten in Deutschland’ – the German Medical Students’ Association – has recently looked into the evidence for and against homeopathy and came up with this poignant declaration:

Here is my translation for those who cannot read German; I have added a few footnotes to explain the German context:

  • Homeopathy does not work beyond placebo [1].
  • The legal health insurances should not reimburse homeopathy [2].
  • The law stating that homeopathy can only be sold in pharmacies should be abolished [3].
  • Medicines should only be licenced, if there is a valid proof of efficacy [4].
  • In public debates, it must be made clear that homeopathy is not part of naturopathy [5].
  • The medical degree in homeopathy must be scrapped [6].
  • The teaching of homeopathy must be evidence-based and context-related [7].

_______________________________

  1. This seems to refer to the wording a German manufacturer of homeopathic preparations tried to suppress.
  2. At the moment most German health insurances do pay for homeopathy.
  3. In Germany, pharmacies have a monopoly on homeopathic remedies.
  4. Since many years, there has been a special regulation in Germany whereby homeopathics could get a licence without proof of efficacy.
  5. German homeopaths tend to be keen on muddying the water by claiming homeopathy is part of naturopathy.
  6. All German students are being taught (and examined on) some rudimentary knowledge of homeopathy.

The new declaration is ‘spot on’. I congratulate the students for their courage and wisdom to publish it. They are the future of German medicine, a future where homeopathy’s place is exclusively in the history books as a bizarre episode of anti-science.

Referring to possible treatments for corona-virus infections during a press-conference, Trump said the following:

“So supposing we hit the body with a tremendous—whether it’s ultraviolet or just a very powerful light—and I think you said that hasn’t been checked because of the testing…And then I said, supposing you brought the light inside the body, which you can do either through the skin or some other way.”

We already suspected that Trump has a thing about UV light.

We also knew that Trump has links to the SCAM scene. And his recent outburst sounds as though the president has come across a particular SCAM called ‘Ultraviolet Blood Irradiation’.

“Ultraviolet Blood Irradiation” (UBI), also called “ BioPhotonic Therapy”, is a treatment that was popular with German naturopaths a few decades ago. It seems to experience a revival and is bound to boom, now that Trump has claimed that UV light in the body might be effective against the corona-virus.

I have conducted in-vitro experiments with this method in the mid 1980s (sorry, I cannot find the publication and am not even sure we ever published the results). They failed to show any meaningful effects on blood rheology which was my main research interest at the time. I thus know how the method works:

  1. You draw a small (10-30 ml) venous blood sample.
  2. You anticoagulate it.
  3. You place it in a special chamber.
  4. You radiate it for a prescribed time with UV light.
  5. You inject the blood back into the patient.

There are semi-automated devices that are commercially available and render the process fairly easy. It seems that UBI has become popular in the US SCAM scene. One advocate of UBI informs us that:

This proven therapy has 70 years of history, helping those who still suffer after exploring other medicines.  Step into the world of over 140 published medical studies where BioPhotonic Therapy has shown amazing success rates.

  • No major side effects
  • Treats over 40 diseases  
  • Low cost 
  • Helps those in need

The same advocate also lists several viral infections for which UBI is, in his opinion, effective:

  • Hepatitis
  • HIV
  • Influenza
  • Herpes simplex/zoster
  • Mononucleosis
  • Mumps
  • Measles Infections
  • Viral Pneumonia
  • Polio

A more modern version of the same method has recently received CE marking to commercially sell its UVLrx 1500 multi-wavelength, intravenous light therapy system in the European Union. The UVLrx 1500 System offers the first intravenous, concurrent delivery of ultraviolet-A (UVA) and multiple visible light wavelengths. Using the company’s patent pending Dry Light Adapter™ and a standard I.V. catheter, the UVLrx 1500 eliminates the need for removal of blood from the body.

UVLrx’s CE marking covers the following indications:

  • Reduction of pain
  • Reduction of pathogens in the blood
  • Reduction of inflammation
  • Immune system modulation
  • Improved ATP synthesis
  • Improved wound healing
  • Improved blood oxygen transport
  • Improved circulation

Needless to say, I think, that there is no good evidence for any of these claims. Yes, there are quite a few papers on UBI and related methods. But most of them are in-vitro studies, while robust clinical trials are missing completely (if someone knows otherwise, I’d be pleased to correct this statement). Needless to say also that UBI is an invasive treatment where lots of things might go badly wrong.

So why is Trump promoting this UV therapy idea?

Search me!

When John Ioannidis publishes a paper, it is well worth, in my view, to pay attention. In the context of this blog, his latest article seems particularly relevant.

The researchers identified the top 100 best-selling books and assessed for both the claims they make in their summaries and the credentials of the authors. Weight loss was a common theme in the summaries of nutritional best-selling books. In addition to weight loss, 31 of the books promised to cure or prevent a host of diseases, including diabetes, heart disease, cancer, and dementia.

The nutritional advice given to achieve these outcomes varied widely in terms of which types of foods should be consumed or avoided and this information was often contradictory between books. Recommendations regarding the consumption of carbohydrates, dairy, proteins, and fat in particular differed greatly between books.

To determine the qualifications of each author in making nutritional claims, the highest earned degree and listed occupations of each author was researched and analyzed. Out of 83 unique authors, 33 had an M.D. or Ph.D degree. Twenty-eight of the authors were physicians, three were dietitians, and other authors held a wide range of jobs, including personal trainers, bloggers, and actors. Of 20 authors who had or claimed university affiliations, seven had a current university appointment that could be verified online in university directories.

The authors concluded that this study illuminates the range of the incongruous information being dispersed to the public and emphasizes the need for future efforts to improve the dissemination of sound nutritional advice.

The authors also provide a ‘sample of claims that appear disputable and/or unsubstantiated according to our expertize and opinion’:

1. “Carbs are destroying your brain”—Grain Brain

2. “Have high blood pressure? Hibiscus tea can work better than a leading hypertensive drug-and without the side effects. Fighting off liver disease? Drinking coffee can reduce liver inflammation. Battling breast cancer? Consuming soy is associated with prolonged survival.”—How Not to Die

3. “Zero Belly diet attacks fat on a genetic level, placing a bull’s-eye on the fat cells that matter most: visceral fat, the type of fat ensconced in your belly.”—Zero Belly Diet

4. “SKIP THE CRUNCHES: They just build muscle under the fat…LESS (EXERCISE) IS MORE”—This Is Why You’re Fat (And How to Get Thin Forever)

5. “Eating pasta, bread, potato, and pizza will actually make you happier, healthier, and thinner—for good”—The Carb Lovers Diet

6. “Skip breakfast, stop counting calories, eat high levels of healthy saturated fat, work out and sleep less, and add smart supplements”—The Bulletproof Diet

7. “Modern “improvements” to our food supply—including refrigeration, sanitation, and modified grains—have damaged our intestinal health. Dr. Axe offers simple ways to get these needed microbes, from incorporating local honey and bee pollen into your diet to forgoing hand sanitizers and even ingesting a little probiotic-rich soil”—Eat Dirt

8. “Overeating doesn’t make you fat; the process of getting fat makes you overeat.”—Always Hungry?

9. “Do you have an overall sense of not feeling your best, but it has been going on so long it’s actually normal to you? You may have an autoimmune disease, and this book is the “medicine” you need.”—The Immune System Recovery Plan

10. “Shows you how to grow new receptors for your seven metabolic hormones, making you lose weight and feel great fast!”—The Hormone Reset Diet

11. “The world’s foremost expert on the therapeutic use of culinary spices, takes an in-depth look at 50 different spices and their curative qualities, and offers spice “prescriptions”–categorized by health condition–to match the right spice to a specific ailment.”—Healing Spices

12. “The idea that people simply eat too much is no longer supported by science”—The Adrenal Reset Diet

13. “Most of us think God is not concerned with what we eat, but the Bible actually offers great insight and instruction about the effects of food on our bodies”—Let Food Be Your Medicine

14. “Dieters can actually lose weight by eating foods, nutrients, teas, and spices that change the chemical balance of the brain for permanent weight loss—a major factor contributing to how quickly the body ages. In fact, everyone can take years off their age by changing their brain chemistry.”—Younger (Thinner) You Diet

15. “Weight gain is not about the food, but about the body’s environment. Excess weight is a result of the body being in a toxic, inflammatory state. If your body is not prepared or ‘primed’ for weight loss, you will fight an uphill biochemical battle”—The Prime

16. “Throwing ice cubes in your water to make it more “structured”. Skipping breakfast, as it could be making you fat. Eating up to 75 percent of your calories each day in fat for optimal health, reduction of heart disease, and cancer prevention”—Effortless Healing

To call these statements ‘disputable’ must be the understatement of the year!

I have long been concerned about the dangerous rubbish published in so-called ‘self-help books’. In 1998, we assessed for the first time the quality of books on so-called alternative medicine (SCAM) [Int J Risk Safety Med 1998, 11: 209-215. [for some reason, this article is not Medline-listed]. We chose a random sample of 6 such books all published in 1997, and we assessed their contents according to pre-defined criteria. The findings were sobering: the advice given in these volumes was frequently misleading, not based on good evidence and often inaccurate. If followed, it would have caused significant harm to patients.

In 2006, we conducted a similar investigation the results of which we reported in the first and second editions of our book THE DESKTOP GUIDE TO COMPLEMENTARY AND ALTERNATIVE MEDICINE. This time, we selected 7 best-sellers in SCAM and scrutinised them in much the same way. We found that almost every treatment seemed to be recommended for almost every condition. There was no agreement between the different books which therapy might be effective for which condition. Some treatments were even named as indications for a certain condition, while, in other books, they were listed as contra-indications for the same problem. A bewildering plethora of treatments was recommended for most conditions, for instance:

  • addictions: 120 different treatments
  • arthritis: 131 different treatments
  • asthma: 119 different treatments
  • cancer: 133 different treatments

This experience, which we published as a chapter in the above-mentioned book entitled AN EPITAPH TO OPINION-BASED MEDICINE, confirmed our suspicion that books on SCAM are a major contributor to the  misinformation in this area.

The new paper by Ioannidis et al adds substantially to all this. It shows that the problem is wide-spread and has not gone away. Since such books have a huge readership, they are a danger to public health. Now that the problem has been identified and confirmed, it is high time, I think, that we do something about it … but I wish I knew what.

ANY SUGGESTIONS?

The ‘Corona-Virus Quackery Club’ (CVQC) is getting positively crowded. You may remember, its members include:

Today we are admitting the herbalists. The reason is obvious: many of them have jumped on the corona band-wagon by trying to improve their cash-flow on the back of the pandemic-related anxiety of consumers. If you go on the Internet you will find many examples, I am sure. I have chosen this website for explaining the situation.

Herbs That Can Stop Coronavirus Reproduction

CoV multiplies fast in the lungs and the stomach and intestines. The more virus, the sicker you get. The herbs are in their scientific names and common names.

    1. Cibotium barometz – golden chicken fern or woolly fern grows in China and Southeast Asia.

      Cibotium Barometz

    2. Gentiana scabra – known as Korean gentian or Japanese gentian seen in the United States and Japan.

      Japanese Gentian

    3. Dioscorea batatas or Chinese Yam grows in China and East Asia

      Chinese Yam

    4. Cassia tora or Foetid cassia, The Sickle Senna, Wild Senna – grows in India and Central America

      Cassia Tora

    5. Taxillus Chinensis – Mulberry Mistletoe

Lectin Plants that Have Anti Coronavirus Properties

Plant Lectins with Antiviral activity Against Coronavirus

From the table above, all have anti coronavirus activity except for garlic. One plant that is effective but not listed is Stinging nettle.

Yes, very nice pictures – but sadly utterly unreliable messages. My advice is that, in case you have concerns about corona (or any other health problem for that matter), please do not ask a herbalist.

WELCOME TO THE CVQC, HERBALISTS!

What Quacks Don’t Tell You is that ‘What Doctors Don’t Tell You‘ and ‘Get Well‘ magazines misinform the public in a scandalously dangerous fashion. If one ever needed evidence for this statement, it is provided by their latest action, explained on their website:

Lynne McTaggart and Bryan Hubbard, editors of What Doctors Don’t Tell You and Get Well magazines, are pleased to announce a series of four FREE weekly webinars, via Zoom, starting Thursday, April 2 designed to maximize your health and wellness in every way during these challenging times.

In these free hour-long sessions, Lynne and Bryan will interview a number of pioneering doctors and specialists, who will give you detailed advice about natural substances that kill viruses, the best supplements, foods and exercises to boost your immune system, and the best techniques to stay calm and centered during these challenging times.

Sign up to be sent the link for the live webinar where you can have the ability to ask your questions to these pioneers, get access to the recording of the webinars and receive a handout of helpful relevant tips to that webinar.

Part 1: Supercharging Yourself With Natural Virus Killers
Thursday, April 2, 2020
9 am PDST/12pm EDST/5 pm BST/6 pm CSTThis webinar will feature the best substances and supplements proven to prevent the spread of viruses. Joining Lynne and Bryan are noted pioneer Dr. Damien Downing, president of the Society for Environmental Medicine, who was part of a team of orthomolecular doctors who devised a special supplement preventative against the coronavirus; Dr. Sarah Myhill, a British integrative doctor noted expert on vitamin C and other natural virus killers; and Dr. Robert Verkerk PhD, the founder and president of the Alliance for Natural Health and an expert on food and health.
This hardly need a comment. Perhaps just this: there are no dietary supplements that have been shown to prevent the spread of the corona virus. Claiming otherwise might be commercially motivated or it might stem from a deep delusion. In any case, it risks the life of those consumers who believe in such bogus claims and, wrongly feel they are protected, and thus neglect effective measures of protection.

My ‘Corona-Virus Quackery Club’ (CVQC) is getting rather popular. The current members,

homeopaths,

colloidal silver crooks,

TCM practitioners,

orthomolecular quacks,

Unani-salesmen

and chiropractors,

are now thinking of admitting the essential oil salesmen. It seems that many of them find it impossible to resist the chance to make a fast buck on the fear many consumers currently have. Take this website for instance:

If you have a breathing aid or respiratory device, use it to reduce breathing difficulties. Alternatively, you can use a breathing ointment like Breathe and Focus Oil. Formulated with menthol, eucalyptus, rosemary and thyme essential oils, this phyto-aromatherapy ointment helps ease breathing difficulties commonly associated with cold, flu, cough, asthma and pneumonia. Gently massage a few drops of Breathe and Focus Oil to your chest and apply 1 to 2 drops to a tissue or handkerchief then inhale the aroma. Repeat as often as necessary.

Studies showed that eucalyptus essential oil contains cineole that helps reduce inflammation and infection in the lungs. Eucalyptus Radiata essential oil has antiviral effects against coronavirus SARS. Rosemary essential oil has been shown to be effective against Klebsiella pneumoniae, a bacteria which causes pneumonia in humans and animals. Thyme essential oil has been shown to have antiviral activities against Influenza A virus (H1N1), while menthol with its cooling-effect has also been shown to reduce breathing difficulties. These essential oils may help you dealing with Covid-19 disease.

Another website even has the promising title ‘What can you try to cure from coronavirus ….’ and it tells us that:

Black cumin can boost immunity, especially in patients with impaired immune systems. According to research, 1 gram Seed capsules, twice daily for four weeks can improve T-cell ratio between positive and negative up to 72%. Increased immunity plays an important role in the healing of colds, influenza, AIDS, and other diseases related to the immune system.

But there is more – so much more that I can here only present a very small selection of that is on offer.

Recommended antiviral essential oils for healthy adults:

  • Cinnamon bark
  • Clove bud
  • Eucalyptus globulus/radiata
  • Lemon
  • Lemon myrtle
  • Manuka
  • Melissa
  • Niaouli
  • Ravensara
  • Ravintsara
  • Rosemary
  • Saro
  • Tea tree
  • Thyme thymol & linalool

Yet another website includes the claim: “The most powerful anti-virus essential oils to provide defence (sic) against coronavirus include:

  • Basil
  • Bergamot
  • Cajuput
  • Cedarwood Virginian
  • Cinnamon
  • Clove Bud
  • Eucalyptus Globulus, Radiata and Smithii
  • Juniper Berry
  • Lavender Spike
  • Laurel leaf
  • Lemon
  • Manuka
  • Niaouli
  • Peppermint
  • Ravensara
  • Ravintsara
  • Rosemary
  • Sage
  • Tea Tree
  • Thyme Sweet Thyme White.”

I know, this is confusing! I do sympathise with the difficulty of choosing between all these recommendation; therefore, let me help you. Here is the full list of essential oils proven to prevent or treat a corona-virus infection:

Yes, that’s right: NO ESSENTIAL OIL HAS EVER BEEN FOUND TO BE EFFECTIVE AGAINST THIS OR ANY OTHER VIRUS INFECTION!

The FDA agree and have therefore sent out letters to seven US companies warning them to stop selling products that claim to cure or prevent COVID-19 infections, stating that such products are a threat to public health because they might prompt consumers to stop or delay appropriate medical treatment.

WELCOME TO THE CVQC, ESSENTIAL OIL SALESMEN!

A new appointment in the realm of so-called alternative medicine (SCAM) has just been announced:

Friends of Science in Medicine (FSM) President, Assoc Professor Ken Harvey MB BS (Melb), FRCPA, AM congratulates Professor Jon Wardle, nurse and naturopath, with postgraduate qualifications in public health, law and health economics, on being appointed to Southern Cross University’s (SCU) Maurice Blackmore Chair of Naturopathic Medicine in Lismore. Professor Wardle has also been appointed as Foundation Director of the National Centre for Naturopathic Medicine (NCNM) funded with $10 Million from the Blackmore Foundation set up to sponsor research into ‘complementary medicine’.

Vice Chancellor, Professor Adam Shoemaker BA (Hons), PhD (ANU), researcher in Indigenous literature and culture, said the benefits of basing the NCNM at Southern Cross were enormous, “Being in a region like the Northern Rivers of New South Wales means we have brilliant local networks in this field. We are also supported by a local community who, like the University, are really receptive to trying new things in order to create a healthier future”.

Professor Harvey comments, “Professor Wardle certainly has challenges ahead. The Northern Rivers region is the anti-vax capital of Australia and some naturopaths advise against vaccination. Degree courses in naturopathy such as the Torrens Bachelor of Health Science (Naturopathy) degree, include studies of homeopathy, iridology and flower essence therapy. None have scientific evidence of efficacy”.

FSM has long argued that health care should be based on scientifically sound research, published in peer-reviewed journals of accepted standing. FSM is equally concerned about medical practitioners offering unproven and often exploitative treatments as it is about complementary medicine practitioners. Professor Harvey said, “some naturopaths practicing in Lismore, associated with SCU, work at clinics that use unverified laboratory tests to make dubious diagnoses and recommend treatment programs that lack evidence of efficacy”.

Professor Harvey (and FSM) conclude that there is an urgent need for evidence-based science to be applied to naturopathy. They trust that Professor Wardle will emulate Professor Edzard Ernst, Foundation Professor of Complementary Medicine at Exeter University, by applying accepted scientific standards to the evaluation of naturopathic interventions.

The March 24 opening of the NCNM in Lismore will feature a panel discussion on the future of health care with guest speakers: Professor Kerryn Phelps AM, former President of the Australasian Integrative Medicine Association, Marcus Blackmore AM, naturopath and Executive Director of Blackmores Ltd, which markets vitamin and herbal products, and Professor Jon Wardle. FSM hopes that the panel will discuss some of the issues raised above.

Sounds exciting, but is Wardle up to the job?

Judging from his publication record, he is certainly a naturopath through and through. He has published lots of papers; as far as I can see most of them are surveys of some sort or another. Many leave me somewhat bewildered. Two examples must suffice:

No 1

Objectives: To explore the recommendations of naturopathic medicine for the management of endometriosis, dysmenorrhea, and menorrhagia, drawing on traditional and contemporary sources.

Design: Content analysis.

Setting: Australia, Canada, and the United States of America (USA).

Subjects: Contemporary sources were identified from reviewing naturopathic higher education institutions’ recommended texts, while traditional sources were identified from libraries which hold collections of naturopathic sources. Sources were included if they were published from 1800 to 2016, were in English, published in Australia, Canada, or the USA, and reported on the topic. Included sources were as follows: 37 traditional texts; 47 contemporary texts; and 83 articles from naturopathic periodicals.

Results: Across included sources, the most reported disciplines were herbal medicine, clinical nutrition, mineral medicines, homeopathy, hydrotherapy, and chemical-based medicines. Herbal medicines were extensively reported from all sources for the management of endometriosis, dysmenorrhea, and menorrhagia. Clinical nutrition was only recommended from contemporary sources for all three conditions. Mineral medicines were mentioned in both traditional and contemporary sources, but were only recommended for dysmenorrhea and menorrhagia. There were limited recommendations for homeopathy and hydrotherapy treatments in all conditions across all sources. Chemical-based medicines were only mentioned for dysmenorrhea and menorrhagia, and recommendations ceased after 1922. Recommendations for endometriosis were not present in any of the traditional sources, across all reported disciplines.

Conclusions: The findings of this article provide insights into the documented historical and contemporary treatments within naturopathic medicine for endometriosis, dysmenorrhea, and menorrhagia. While philosophical principles remain the core of naturopathic practice, the therapeutic armamentarium appears to have changed over time, and a number of the original naturopathic treatments appear to have been retained as key elements of treatment for these conditions. Such insights into naturopathic treatments will be of particular interest to clinicians providing care to women, educators designing and delivering naturopathic training, and researchers conducting clinical and health service naturopathic research.

No 2

Complementary and alternative medicine (CAM) is an increasingly prevalent part of contemporary health care. Whilst there have been some attempts to understand the dynamics of CAM integration in the health care system from the perspective of conventional care providers and patients, little research has examined the view of CAM practitioners. This study aims to identify the experiences of integration within a conventional healthcare system as perceived by naturopaths. Qualitative semi-structured interviews were conducted using a purposeful sample of 20 practising naturopaths in South East Queensland, Australia to discuss their experiences and perceptions of integrating with conventional medical providers. Analysis of the interviews revealed five broad challenges for the integration of CAM according to naturopaths: competing paradigms between CAM and conventional medicine; co-option of CAM by conventional medical practitioners; the preservation of separate CAM and conventional medical worlds by patients and providers due to lack of formalised relations; negative feedback and biases created through selective or limited experience or information with CAM; and indifferent, reactive and one-sided interaction between CAM and conventional medical providers. Naturopaths support the integration of health services and attempt to provide safe and appropriate care to their patients through collaborative approaches to practice. The challenges identified by naturopaths associated with integration of CAM with conventional providers may impact the quality of care of patients who choose to integrate CAM and conventional approaches to health. Given the significant role of naturopaths in contemporary health-care systems, these challenges require further research and policy attention.

So, is Jon Wardle up to the job?

The answer obviously depends on what the job is.

If it is about publishing 100 more surveys that show nothing of much value and are essentially SCAM-promotion, then he ought to be fine. If it is about rigorously testing which SCAMs generate more good than harm, then ‘Houston, we have a problem’!

It is not often that a top journal reports a trial of a (mostly) herbal remedy. For this reason alone, this Italian study (published in the Journal of the American Heart Association) is remarkable.

Sixty‐nine uncontrolled hypertension patients, aged 40 to 68 years, on antihypertensive medication were enrolled in 2 double‐blind studies. In the first study, 45 were randomized to placebo or a new nutraceutical combination named AkP05. Blood pressure (BP), endothelial function, and circulating nitric oxide were assessed before and at the end of 4 weeks of treatment. In the second study, 24 patients were randomized to diuretic or AkP05 for 4 weeks and underwent a cardiopulmonary exercise test to evaluate the effects of AkP05 on functional capacity of the cardiovascular, pulmonary, and muscular systems. Furthermore, vascular and molecular studies were undertaken on mice to characterize the action of the single compounds contained in the AkP05 nutraceutical combination.

AkP05 supplementation reduced BP, improved endothelial function, and increased nitric oxide release; cardiopulmonary exercise test revealed that AkP05 increased maximum O2 uptake, stress tolerance, and maximal power output. In mice, AkP05 reduced BP and improved endothelial function, evoking increased nitric oxide release through the PKCα/Akt/endothelial nitric oxide synthase pathway and reducing reactive oxygen species production via NADPH‐oxidase inhibition. These effects were mediated by synergism of the single compounds of AkP05.

The authors concluded that this is the first study reporting positive effects of a nutraceutical combination on the vasculature and exercise tolerance in treated hypertensive patients. Our findings suggest that AkP05 may be used as an adjunct for the improvement of cardiovascular protection and to better control BP in uncontrolled hypertension.

These are good studies, it seems. However, I am puzzled by the authors’ conclusions:

  1. I very much doubt that this is the first such study.
  2. The studies did not test AkP05 ‘as an adjunct’, so their findings cannot suggest that it should be used as such.

And now you are, of course, all dying to learn what this new wonder nutraceutical contains. It is a mixture of Bacopa monnieri, extract of Ginkgo biloba leaves, extract of green tea leaves, and phosphatidylserine and is manufactured by Damor Farmaceutici, Italy.

About 85% of German children are treated with herbal remedies. Yet, little is known about the effects of such interventions. A new study might tell us more.

This analysis accessed 2063 datasets from the paediatric population in the PhytoVIS data base, screening for information on indication, gender, treatment, co-medication and tolerability. The results suggest that the majority of patients was treated with herbal medicine for the following conditions:

  • common cold,
  • fever,
  • digestive complaints,
  • skin diseases,
  • sleep disturbances
  • anxiety.

The perceived effect of the therapy was rated in 84% of the patients as very good or good without adverse events.

The authors concluded that the results confirm the good clinical effects and safety of herbal medicinal products in this patient population and show that they are widely used in Germany.

If you are a fan of herbal medicine, you will be jubilant. If, on the other hand, you are a critical thinker or a responsible healthcare professional, you might wonder what this database is, why it was set up and how exactly these findings were produced. Here are some details:

The data were collected by means of a retrospective, anonymous, one-off survey consisting of 20 questions on the user’s experience with herbal remedies. The questions included complaints/ disease, information on drug use, concomitant factors/diseases as well as basic patient data. Trained interviewers performed the interviews in pharmacies and doctor’s offices. Data were collected in the Western Part of Germany between April 2014 and December 2016. The only inclusion criterion was the intake of herbal drugs in the last 8 weeks before the individual interview. The primary endpoint was the effect and tolerability of the products according to the user.

And who participated in this survey? If I understand it correctly, the survey is based on a convenience sample of parents using herbal remedies. This means that those parents who had a positive experience tended to volunteer, while those with a negative experience were absent or tended to refuse. (Thus the survey is not far from the scenario I often use where people in a hamburger restaurant are questioned whether they like hamburgers.)

So, there are two very obvious factors other than the effectiveness of herbal remedies determining the results:

  1. selection bias,
  2. lack of objective outcome measure.

This means that conclusions about the clinical effects of herbal remedies in paediatric patients are quite simply not possible on the basis of this survey. So, why do the authors nevertheless draw such conclusions (without a critical discussion of the limitations of their survey)?

Could it have something to do with the sponsor of the research?

The PhytoVIS study was funded by the Kooperation Phytopharmaka GbR Bonn, Germany.

Or could it have something to do with the affiliations of the paper’s authors:

1 Institute of Pharmacy, University of Leipzig, Brüderstr. 34, 04103, Leipzig, Germny. nieberkaren@gmx.de.

2 Kooperation Phytopharmaka GbR, Plittersdorfer Str. 218, 573, Bonn, Germany. nieberkaren@gmx.de.

3 Institute of Medical Statistics and Computational Biology, Faculty of Medicine, University of Cologne, Kerpener Str. 62, 50937, Cologne, Germany.

4 ClinNovis GmbH, Genter Str. 7, 50672, Cologne, Germany.

5 Bayer Consumer Health, Research & Development, Phytomedicines Supply and Development Center, Steigerwald Arzneimittelwerk GmbH, Havelstr. 5, 64295, Darmstadt, Germany.

6 Kooperation Phytopharmaka GbR, Plittersdorfer Str. 218, 53173, Bonn, Germany.

7 Institute of Pharmaceutical Biology, Goethe University Frankfurt, Max-von-Laue-Str. 9, 60438, Frankfurt, Germany.

8 Chair of Naturopathy, University Medicine Rostock, Ernst-Heydemann Str. 6, 18057, Rostock, Germany.

WHAT DO YOU THINK?

This review provides published data on so-called alternative medicine (SCAM)-related liver injuries (DILI) in Asia, with detail on incidences, lists of most frequently implicated herbal remedies, along with analysis of patient population and their clinical outcomes.

Its authors conclude that SCAM use is widely prevalent in Asia and is associated with, among other adverse effects, hepatotoxicity. Both proprietary as well as non-proprietary or traditional SCAMs have been implicated in hepatotoxicity. Acute hepatocellular pattern of liver injury is the most common type of liver injury seen, and the spectrum of liver-related adverse events range from simple elevation of liver enzymes to the very serious ALF and ACLF, which may, at times, require liver transplant.

SCAM-related liver injury is one among the major causes for hepatotoxicity, including ALF and ACLF worldwide, with high incidence among Asian countries. Patient outcomes associated with SCAM-DILI are generally poor, with very high mortality rates in those with chronic liver disease. Stringent regulations, at par with that of conventional modern medicine, are required, and may help improve safety of patients seeking SCAM for their health needs. Regional surveillance including post-marketing analysis from government agencies associated with drug regulation and control in tandem with national as well as regional level hepatology societies are important for understanding the true prevalence of DILI associated with SCAM. An integrated approach used by practitioners combining conventional and traditional medicine to identify safety and efficacy of SCAMs is an unmet need in most of the Asian countries. Endorsement of scientific methodology with good quality preclinical and clinical trials and abolishment of unhealthy publication practices is an area that needs immediate attention in SCAM practice. Such holistic standard science-based approaches could help ameliorate liver disease burden in the general and patient population.

I congratulate the authors to this excellent paper. It contains a wealth of information and is well worth reading in full. The review will serve me as a valuable source of data for many years to come.

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