Edzard Ernst

MD, PhD, FMedSci, FSB, FRCP, FRCPEd

According to our friend Dana Ullman, “homeopathy has had a long tradition within Russia. Even though it was not officially recognized during the Communist regime, it was tolerated. And perhaps in part because it did not receive governmental sanction, the Russian people developed a trust in homeopathy. Due to the fact that homeopathic physicians worked outside of governmental medicine, homeopathy was a part of Russia’s “new economy”. People had to pay for homeopathic care, rather than receive it for free.

Homeopathy is still the minority practice. I was told that there are approximately one million medical doctors in Russia and its surrounding republics, with 15,000 medical doctors who use homeopathic medicines regularly, and about 3,000 medical doctors who specialize in classical homeopathy.”

But the ‘free ride’ of homeopathy seems to come to an end. We have seen this happening, for instance in the US, UK, Australia, and Germany. And now it is happening also in Russia:

It has just been reported that the Russian Academy of Sciences (RAS) has labelled homeopathic medicine a health hazard. The organization is now petitioning Russia’s Ministry of Health to abandon the use of homeopathic medicine in the country’s state hospitals, the RBC news outlet reported Monday.

A RAS committee warns that some patients were rejecting standard medicine for serious conditions in favour of homeopathic remedies, a move that almost inevitably puts their lives in danger. The committee also noted that, because of sloppy quality control during the manufacturing processes, some unlicensed homeopathic remedies contain toxic substances which harm patients in a direct fashion.

“The principles of homeopathy contradict known chemical, physical and biological laws and persuasive scientific trials proving its effectiveness are not available,” the committee stated in its report.

The move forms part of a growing backlash against homeopathy in Russia. Last month, students at the First Moscow State Medical University filed a petition to ban homeopathic principles from being taught in medical schools. Russia’s Federal Customs Service also introduced new rules in November 2016, forcing manufacturers to prove the effectiveness of any homeopathic products that they wish to sell.

To this, I have little to add; perhaps just this: ABOUT TIME TOO!

Yes, homeopaths are incredibly fond of the notion that homeopathy has been proven to work in numerous population studies of outbreaks of infectious diseases. The argument is bound to come up in any discussion with a ‘well-informed’ homeopathy fan. Therefore, it might be worth addressing it once and for all.

This website offers a fairly good summary of what homeopaths consider to be convincing evidence. It also provides links to the original articles which is valuable for all who want to study them in full detail. I will therefore present the crucial passage here unchanged.

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By the end of year 2014, there have been 19 papers published on Epidemiological studies on 7 epidemic diseases (scarlet fever, typhus fever, Cholera, Dengue, meningococcal, influenza and Leptospirosis) in 11 peer-reviewed (beyond year 1893) journals in evidence of Homeopathy including 2 Randomised Controlled Trials.

1. Samuel Hahnemann, “The Cure and prevention of scarlet fever”, Zeitschrift für Praktischen Medizin (Journal of Practical Medicine), 1801, Republished in Lesser Writings. B.Jain Publishing, New Delhi

Preventive use of homeopathy was first applied in 1799 during an epidemic of scarlet fever in Königslütter, Germany, when Dr. Hahnemann prescribed a single dose of Belladonna, as the remedy of the genus epidemicus to susceptible children in the town with more than 95% success rate. In this paper, he also specified how the Belladonna has to be potentised to 1/24,000,000 dilution. His recommended dose of Belladonna was 0.0416 nanograms to be repeated every 72 hrs. This is the first recorded nano dose of medicine used in treatment of any disease [6]. It was another 125 years before Gladys Henry and George Frederick developed a vaccine for scarlet fever in 1924.

2. Samuel Hahnemann, “Scarlet fever and Purpura miliaris, two different diseases”, Zeitschrift für Praktischen Medizin, vol. 24, part. 1, 1806

3. Samuel Hahnemann, “Observations on scarlet fever”, Allgemeine Reichanzeiger (General Reich Gazette), No. 160, Germany, 1808

4. Samuel Hahnemann, “Reply to a question about the prophylactic for scarlet fever”, Zeitschrift für Praktischen Medizin, vol. 27, part. 4, p. 152-156, 1808

5. Samuel Hahnemann, “Treatment of typhus & fever at present prevailing”, Allgemeine Reichanzeiger, No. 6, Jan. 1814.

6. Hufeland, Prophylactic powers of Belladonna against Scarlet Fever , The Lancet, 1829
The proper use of belladonna has, in most cases, prevented infection. Numerous observations have shown that, by the general use of belladonna, epidemics of scarlet fever have actually been arrested. In those few instances where the use of belladonna was insufficient to prevent infection, the disease has been invariably slight. The Prussian (German Empire) Government ordered the use of the prophylactic during all scarlet fever epidemics

7. Samuel Hahnemann, “Cure and prevention of Asiatic cholera”, Archiv für die homöopathische Heilkunst (Archives for the Homoeopathic Healing Art), Vol. 11, part 1, 1831.
Cuprum 30c once every week as preventive medicine

8. Samuel Hahnemann, “On the contagiousness of cholera”. British Homoeopathic Journal, Vol. 7, 1849

9. Samuel Hahnemann, “Appeal to Thinking Philanthropists Respecting the Mode of Propagation of the Asiatic Cholera”, 20 pages, 1831. Republished in British Homoeopathic Journal, Oct 1849.

He said, “On board ships – in those confined spaces, filled with mouldy watery vapours, the cholera-miasm finds a favourable element for its multiplication, and grows into an enormously increased brood of those excessively minute, invisible, living creatures, so inimical to human life, of which the contagious matter of the cholera most probably consists millions of those miasmatic animated beings, which, at first developed on the broad marshy banks or the tepid Ganges– on board these ships, I say, this concentrated aggravated miasm kills several of the crew …” [7].
It was another 59 years (1890) before Koch saw these organisms, and later on orthodox medicine gave them the name ‘germs’

10. Charles Woodhull Eaton, The Facts about Variolinum, Transactions of the American Institute of Homoeopathy, 1907
2806 patients were treated prophylactically with Variolinum 30 (a nosode) for prevention of smallpox in Iowa. Of the 547 patients definitely exposed, only 14 developed the disease. Efficacy rate of 97.5%

11. Taylor Smith A, Poliomyelitis and prophylaxis British Homoeopathic Journal, 1950
In 1950 during an epidemic of poliomyelitis, Dr Taylor Smith of Johannesburg, South Africa protected 82 people with homoeopathic Lathyrus sativus. Of the 82 so immunised, 12 came into direct contact with disease. None were infected.

12. Oscillococcinum 200c in the treatment of influenza during epidemic in France from 1984-1987, British Journal of Clinical Pharmacology (1989)
A DBRPCT, Oscillococcinum 200c taken twice daily for 5 days significantly increased the rate of cure within two days (n=487, 237 treated and 241 on placebo), absence of symptoms at 48 hours, relative risk estimate significantly favour homeopathy (p=0.048), no pain and no fever (p=0.048), recovery rate (headache, stiffness, articular pain, shivering reduction) at 48 hours better in homeopathy group (p=0.032)

13. Bernard Leary, Cholera 1854 Update, British Homoeopathic Journal, 1994
Sir William Wilde, the well-known allopathic doctor of Dublin, which in his work entitled “Austria and its Institutions”, wrote: “Upon comparing the report of the treatment of Cholera in the Homeopathic hospital testified to by two allopathic medical inspectors appointed by Government with that of the treatment of the same disease in the other hospitals of Vienna during the same period the epidemic of 1836, it appeared that while two-thirds of the cases treated by Dr. Fleischmann the physician of the Homeopathic hospital, recovered, two-thirds of those treated by the ordinary methods in the other hospitals died.”

14. Meningococcinum – its protective effect against meningococcal disease, Homeopathy Links, 2001 (2001)
A total of 65,826 people between the ages of 0–20 were immunised homeopathically to protect against meningococcal disease while 23,532 were not. Over a year period, 4 out of 65,826 protected homeopathically developed meningococcal infection. 20 out of 23,532 not protected developed meningococcal infection. Based on the infection rate in the unprotected group, 58 cases of infection could have been expected in the homeopathically protected group. Instead, there were only four cases of meningococcal infection. Statistical analysis showed that homeopathic immunisation offered 95% protection in the first six months and 91% protection over the year against meningococcal disease. [8]

15. Contribution of homeopathy to the control of an outbreak of dengue epidemic in Macaé, Rio de Janeiro, Brazil in 2007-8 , International Journal of High Dilution Research, 2008
In a campaign ‘Homeopathy campaign against dengue’ by Brazilian Govt, “156,000 doses of homeopathic remedy were freely distributed in April and May 2007 to asymptomatic patients and 129 doses to symptomatic patients treated in outpatient clinics, according to the notion of genus epidemicus . The remedy used was a homeopathic complex against dengue containing Phosphorus 30c, Crotalus horridus 30c and Eupatorium perfoliatum 30c. The incidence of the disease in the first three months of 2008 fell 93% by comparison to the corresponding period in 2007, whereas in the rest of the State of Rio de Janeiro there was an increase of 128%.”

16. Marino R. Eupatorium perfoliatum 30c for the Dengue Epidemics in Brazil in 2007. International Journal of High Dilution Research, 2008
In May 2001, prophylactic use of Eupatorium perfoliatum 30c single dose was given during a dengue outbreak to 40% of residents in the most highly affected neighbourhood which resulted in significant decrease in dengue incidence by 81.5% (p<0.0001) when compared with those neighbourhoods that did not receive homeopathic prophylaxis.

17. Bracho et. al. Application of 200C potency of bacteria for Leptospirosis epidemic control in Cuba 2007-8 (2010)
Conducted by the Finlay Institute, a vaccines producer in Cuba gave 2.308562 million (70% of the target population above the age of 1 year) people in Cuba given two doses (1 dose=5 drops) of 200C potency of a nosode prepared from Leptospirosis bacteria, each (7-9 days apart), for protection against Leptospirosis (fever+jaundice+ inflammation in kidney+enlargement of spleen) with 84% decrease in disease incidence and only 10 reported cases. Dramatic decrease in morbidity within two weeks and zero morbidity of hospitalised patients, non-treated (8.8 millions) area saw an increase in number of cases from 309 cases in 2007 to 376 in 2008 representing a 21% increase. The cost of homeopathic immunization =1/15th of conventional vaccine.

18. Effect of individualized homoeopathic treatment in influenza like illness, Indian Journal of Research in Homeopathy (2013)
A multicenter, single blind, randomized, placebo controlled study to evaluate the effect of homoeopathic medicines in the treatment of Influenza like illness and to compare the efficacy of LM (50 millisimal) potency vis-à-vis centesimal (C) potency. In LM group (n=152), C group (n=147) or placebo (n=148) group. The study revealed the significant effect of individualized homoeopathic treatment in the patients suffering from ILI with no marked difference between LM and Centesimal groups. The medicines which were commonly prescribed were: Arsenic album, Bryonia alba, Rhus tox., Belladonna, Nux vomica, Sepia, Phosphorus, Gelsemium, Sulphur, Natrum mur. and Aconitum napellus. [9]

19. Reevaluation of the Effectiveness of Homoeoprophylaxis Against Leptospirosis in Cuba in 2007-8, Journal of Evidence-based Complementary & Alternative Medicine (2014)
The results support the previous conclusions that homoeoprophylaxis can be used to effectively immunize people against targeted infectious diseases such as leptospirosis.

References
[1] Iman Navab, Lives saved by Homeopathy in Epidemics and Pandemics, https://drnancymalik.wordpress.com/2013/01/23/epidemics-and-pandemics/

[2] Reshu Agarwal, Natural History of Disease and Homeopathy at different levels of Intervention, http://www.homeorizon.com/homeopathic-articles/homeopathic-philosophy/disease-history

[3] Homoeopathy- Science of Gentle Healing, Deptt. of AYUSH, Ministry of Health & Family Welfare, Govt, of India, 2013, http://www.ccrhindia.org/Dossier/content/page22.html

[4] Conversation with David Little, http://hpathy.com/homeopathy-papers/conversations-with-david-little/

[5] Nancy Malik, Principles of Homeopathy Explained, 2015, https://drnancymalik.wordpress.com/article/homeopathy-explained/

[6] Nancy Malik, Recent Advances in Nanoparticle Research in Homeopathy, Homeopathy 4 Everyone, Vol.12, Issue 6, 18 June 2015, http://hpathy.com/scientific-research/recent-advances-in-nanoparticle-research-in-homeopathy/

[7] Samuel Hahnemann, “Appeal to Thinking Philanthropists Respecting the Mode of Propagation of the Asiatic Cholera”, 20 pages, 1831, Translated by R E Dudgeon, M.D. in The Lesser Writings of Samuel Hahnemann, 1851, B Jain Publishers, reproduced edition, 2002, p. 758

[8] Fran Sheffield, Homeoprophylaxis: Human Records, Studies and Trials, 2014, http://homeopathyplus.com/Homeoprophylaxis-Human-Records-Studies-Trials.pdf

[9] Homoeopathy in Flu-like Illness- Factsheet, Central Council for Research in Homoeopathy, Deptt. of AYUSH, Ministry of Health & Family Welfare, Govt, of India, 2015, http://ccrhindia.org/pdf/swineflu.pdf

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Whenever I read articles of this nature, I get a little embarrassed. It seems obvious to me that the authors of such reviews have done some ‘research’ and believe strongly in the correctness in what they write. It embarrasses me to see how such people, full of good will, can be so naïve, ignorant and wrong. They clearly fail to understand several crucial issues. To me. this seems like someone such as me lecturing others about car mechanics, quantum physics or kite flying. I have no idea about these subjects, and therefore it would be idiotic to lecture others about them. But homeopaths tend to be different! And this is when my embarrassment quickly turns into anger: articles like the above spread nonsense and misguide people about important issues. THEY ARE DANGEROUS! There is little room for embarrassment and plenty of room for criticism. So, let’s criticise the notions advanced above.

In my recent book, I briefly touched upon epidemics in relation to homeopathy:

Epidemics are outbreaks of disease occurring at the same time in one geographical area and affecting large number of people. In homeopathy, epidemics are important because, in its early days, they seemed to provide evidence for the notion that homeopathy is effective. The results of homeopathic treatment seemed often better than those obtained by conventional means. Today we know that this was not necessarily due to the effects of homeopathy per se, but might have been a false impression caused by bias and confounding.

This tells us the main reason why the much-treasured epidemiological evidence of homeopaths is far from compelling. The review above does not mention these caveats at all. But it is lousy also for a whole host of other reasons, for instance:

  • The text contains several errors (which I find too petty to correct here).
  • The list of studies is the result of cherry-picking the evidence.
  • It confuses what epidemiological studies are; RCTs are certainly not epidemiological studies, for instance.
  • It also omits some of the most important epidemiological studies suggesting homeopathy works.
  • It cites texts that are clearly not epidemiological studies.
  • Several studies are on prevention of illness rather than on treatment.
  • Some studies do not even employ homeopathy at all.

In the typical epidemiological case/control study, one large group of patients [A] is retrospectively compared to another group [B]. By large, I mean with a sample size of thousands of patients. In our case, group A has been treated homeopathically, while group B received the treatments available at the time. It is true that several of such reports seemed to suggest that homeopathy works. But this does by no means prove anything; the result might have been due to a range of circumstances, for instance:

  • group A might have been less ill than group B,
  • group A might have been richer and therefore better nourished,
  • group A might have benefitted from better hygiene in the homeopathic hospital,
  • group A might have received better care, e. g. hydration,
  • group B might have received treatments that made the situation not better but worse.

Because these are RETROSPECTIVE studies, there is no way to account for these and many other factors that might have influenced the outcome. This means that epidemiological studies of this nature can generate interesting results which, in turn, need testing in properly controlled studies where these confounding factors are adequately controlled for. Without such tests, they are next to worthless for recommendations regarding clinical practice.

As it happens, the above author also included two RCT in the review (these are NOT epidemiological studies, as I already mentioned). Let’s have a quick look at them.

The first RCT is flawed for a range of reasons and has been criticised many times before. Even its authors state that “the result cannot be explained given our present state of knowledge, but it calls for further rigorously designed clinical studies.” More importantly, the current Cochrane review of Oscillococcinum, the remedy used in this study, concluded: “There is insufficient good evidence to enable robust conclusions to be made about Oscillococcinum® in the prevention or treatment of influenza and influenza-like illness.”

The second RCT is equally flawed; for instance, its results could be due to the concomitant use of paracetamol, and it seems as though the study was not double blind. The findings of this RCT have so far not been confirmed by an independent replication.

What puzzles me most with these regularly voiced notions about the ‘epidemiological evidence’ for homeopathy is not the deplorable ineptitude of those who promote them, but it is this: do homeopaths really believe that conventional medics and scientists would ignore such evidence, if it were sound or even just encouraging? This assumes that all healthcare professionals (except homeopaths) are corrupt and cynical enough not to follow up leads with the potential to change medicine for ever. It assumes that we would supress knowledge that could save the lives of millions for the sole reason that we are against homeopathy or bribed by ‘BIG PHARMA’.

Surely, this shows more clearly than anything else how deluded homeopaths really are!!!

 

Today is WORLD CANCER DAY.

Yesterday I prepared you for this event by alerting you to a disgusting cancer scam, and today I want to contrast this with more encouraging news from the strange world of alternative medicine. So I searched Medline for a fitting, recent publication showing at least some value of an alternative therapy. Believe me, such papers are few and far between.

But here is one:

The aim of this Cochrane review was to assess effects of yoga on health-related quality of life, mental health and cancer-related symptoms among women with a diagnosis of breast cancer who are receiving active treatment or have completed treatment. The authors conducted extensive literature searches and applied no language restrictions. RCTs were eligible, if they (1) compared yoga interventions to no therapy or to any other active therapy in women with a diagnosis of breast cancer, and (2) assessed at least one of the primary outcomes on patient-reported instruments, including health-related quality of life, depression, anxiety, fatigue or sleep disturbances.

Two review authors independently collected data on methods and results. The risk of publication bias was assessed through visual analysis of funnel plot symmetry and heterogeneity between studies. Subgroup analyses were conducted for current treatment status, time since diagnosis, stage of cancer and type of yoga intervention.

Twenty-four studies with a total of 2166 participants were included, 23 of which provided data for meta-analysis. Thirteen studies had low risk of selection bias, five studies reported adequate blinding of outcome assessment and 15 studies had low risk of attrition bias. Seventeen studies that compared yoga versus no therapy provided moderate-quality evidence showing that yoga improved health-related quality of life, reduced fatigue and reduced sleep disturbances in the short term. There was an overall low risk of publication bias.

Yoga did not appear to reduce depression or anxiety in the short term and had no medium-term effects on health-related quality of life or fatigue. Four studies that compared yoga versus psychosocial/educational interventions provided moderate-quality evidence indicating that yoga can reduce depression, anxiety and fatigue in the short term. Very low-quality evidence showed no short-term effects on health-related quality of life or sleep disturbances. Three studies that compared yoga to exercise presented very low-quality evidence showing no short-term effects on health-related quality of life or fatigue. No trial provided safety-related data.

The authors concluded that moderate-quality evidence supports the recommendation of yoga as a supportive intervention for improving health-related quality of life and reducing fatigue and sleep disturbances when compared with no therapy, as well as for reducing depression, anxiety and fatigue, when compared with psychosocial/educational interventions. Very low-quality evidence suggests that yoga might be as effective as other exercise interventions and might be used as an alternative to other exercise programmes.

As I said, this is most encouraging. Many women are attracted by yoga, and the news that it can improve their symptoms is clearly positive. I have said it often, but I say it again: in supportive and palliative cancer care there might be an important role for several forms of CAM. One has to make sure though that they do not interfere with conventional treatments, and – this is very important – cancer patients must not be misled to believe that they can be used to treat or cure cancer. Finally, patients should not pitch their hopes too high: the effect sizes of alternative treatments in cancer care are invariably small or modest which means that they can help to reduce symptoms but are unlikely to get rid of them completely.

On an even more sober note, I have to reiterate that none of the trials included in the above review reported safety data (yoga is not totally devoid of adverse-effects!). This is an almost stereotypical finding when assessing clinical trials of alternative therapies. It discloses a clear and unacceptable breach of publication ethics. How can we ever get a realistic impression of the risks of alternative medicine, if adverse effects remain unreported? It is high time that researchers, authors, journal editors and reviewers get this message and behave accordingly.

Tomorrow is WORLD CANCER DAY. To mark this important occasion, I intend to publish not just one but two posts. Today’s post discloses one of the more sickening alternative cancer scams I have seen for a long time (tomorrow’s post will be a lot more encouraging): baking soda as a cancer cure. Here is what some charlatans tell the most vulnerable of our patients.

START OF QUOTE

Even the most aggressive cancers which have metastasized have been reversed with baking soda cancer treatments… Doctors and pharmaceutical companies make money from it. That’s the only reason chemotherapy is still used. Not because it’s effective, decreases morbidity, mortality or diminishes any specific cancer rates. In fact, it does the opposite. Chemotherapy boosts cancer growth and long-term mortality rates and oncologists know it…

Studies have shown that dietary measures to boost bicarbonate levels can increase the pH of acidic tumors without upsetting the pH of the blood and healthy tissues. Animal models of human breast cancer show that oral sodium bicarbonate does indeed make tumors more alkaline and inhibit metastasis. Based on these studies, plus the fact that baking soda is safe and well tolerated, world renowned doctors such as Dr. Julian Whitaker have adopted successful cancer treatment protocols as part of an overall nutritional and immune support program for patients who are dealing with the disease…

When taken orally with water, especially water with high magnesium content, and when used transdermally in medicinal baths, sodium bicarbonate becomes a first-line medicinal for the treatment of cancer, and also kidney disease, diabetes, influenza and even the common cold. It is also a powerful buffer against radiation exposure, so everyone should be up to speed on its use. Everybody’s physiology is under heavy nuclear attack from strong radioactive winds that are circling the northern hemisphere…

The pH of our tissues and body fluids is crucial and central because it affects and mirrors the state of our health or our inner cleanliness. The closer the pH is to 7.35-7.45, the higher our level of health and wellbeing. Staying within this range dramatically increases our ability to resist acute illnesses like colds and flues as well as the onset of cancer and other diseases. Keeping our pH within a healthy range also involves necessary lifestyle and dietary changes that will protect us over the long term while the use of sodium bicarbonate gives us a jump-start toward increased alkalinity…

Basically, malignant tumors represent masses of rapidly growing cells. The rapid rate of growth experienced by these cells means that cellular metabolism also proceeds at very high rates. Therefore, cancer cells are using a lot more carbohydrates and sugars to generate energy in the form of ATP (adenosine triphosphate). However, some of the compounds formed from the energy production include lactic acid and pyruvic acid. Under normal circumstances, these compounds are cleared and utilized as soon as they are produced. But cancer cells are experiencing metabolism at a much faster rate. Therefore, these organic acid accumulate in the immediate environment of the tumor. The high level of extracellular acidity around the tumor is one of the chief driving force behind the metastasis of cancer tumors. Basically, cancer cells need an acidic environment to grow and spread rapidly…

One does not have to be a doctor to practice pH medicine. Every practitioner of the healing arts and every mother and father needs to understand how to use sodium bicarbonate. Bicarbonate deficiency is a real problem that deepens with age so it really does pay to understand and appreciate what baking soda is all about.

END OF QUOTE

I am sure you agree: this is not just unethical and irresponsible; it is vile!

There are far too many falsehoods in this text (and most of them are too obvious) for me to even begin to correct them.

Why do I post this just before WORLD CANCER DAY?

Because I believe that cancer patients need to be protected from people and institutions who tout dangerous nonsense. Sadly, in the realm of alternative medicine, there are many of such charlatans.

A new joint position statement of the Italian Society of Diabetology (SID) and of the Italian Society for the Study of Arteriosclerosis (SISA) has recently been published. In the context of this blog, it seems relevant enough for its summary to be reproduced here:

Evidence showed that LDL-cholesterol lowering is associated with a significant cardiovascular risk reduction. The initial therapeutic approach to hypercholesterolaemia includes dietary modifications but the compliance to recommendations is often inadequate. Some dietary components with potential cholesterol-lowering activity are present in small amounts in food. Therefore, in recent years the use of “nutraceuticals” (i.e., nutrients and/or bioactive compounds with potential beneficial effects on human health) has become widespread. Such substances may be added to foods and beverages, or taken as dietary supplements (liquid preparations, tablets, capsules). In the present manuscript, the cholesterol-lowering activity of some nutraceuticals (i.e. fiber, phytosterols, soy, policosanol, red yeast rice and berberine) will be discussed along with: 1) the level of evidence on the cholesterol-lowering efficacy emerging from clinical trial; 2) the possible side effects associated with their use; 3) the categories of patients who could benefit from their use.

DATA SYNTHESIS:

Based on the current literature, the cholesterol-lowering effect of fiber, phytosterols and red yeast rice is consistent and supported by a good level of evidence. Over berberine, there is sufficient evidence showing significant cholesterol-lowering effects, although the results come from studies carried out almost exclusively in Asian populations. Data on the effects of soy are conflicting and, therefore, the strength of recommendation is quite low. The evidence on policosanol is inconclusive.

CONCLUSION:

Although health benefits may arise from the use of nutraceuticals with cholesterol-lowering activity, their use might be also associated with possible risks and pitfalls, some of which are common to all nutraceuticals whereas others are related to specific nutraceuticals.

END OF QUOTE

Many advocates of alternative medicine are highly sceptical of the value of statins. Yet, it seems clear that statins exert considerably larger effects on our lipid profile than nutraceuticals. So, why not use the treatment that is best documented and most efficacious? One answer could lie in the well-known adverse effects of statins. However, can we be sure that nutraceuticals are devoid of serious side-effects? I am not sure that we can: statins have been fully investigated, and we therefore are well-informed about their risks. Nutraceuticals, by contrast, have not been monitored in such detail, and their safety profile is therefore not as well-understood.

Other advocates of alternative medicine argue that cholesterol (I use the term simplistically without differentiating between the ‘good and bad’ cholesterol) has been hyped by the pharmaceutical industry and is, in truth, not nearly as important a risk factor as we have been led to believe. This line of thought would consequently deny the need to lower elevated cholesterol levels and therefore negate the need for cholesterol-lowering treatments. This stance may be popular, particularly in the realm of alternative medicine, but, to the best of my knowledge, it is erroneous.

Obviously, the first line treatment for people with pathological lipid profiles is the adoption of different life-styles, particularly in terms of nutrition. This may well incorporate some of the nutraceuticals mentioned above. If that strategy is unsuccessful in normalizing our blood lipids – and it often is – we should consider the more effective conventional medications; and that unquestionably includes statins.

I do not expect that everyone reading these lines will agree with me, yet, after studying the evidence, this is my honest conclusion – and NO, I am not paid or otherwise rewarded by the pharmaceutical industry or anyone else!

 

Wellness?

Yes, it’s a new buzz-word in the realm of alternative medicine – actually, not so new; it’s been around for years and seems to attract charlatans of all imaginable types.

But what precisely is it?

The authors of this paper explain: “While the concept of wellness is still evolving, it is generally recognized that wellness is a holistic concept best represented as a continuum, with sickness, premature death, disability, and reactive approaches to health on one side and high-level wellness, enhanced health, and proactive approaches to health and well-being on the other. It is further acknowledged that wellness is multidimensional and includes physiologic, psychological, social, ecologic, and economic dimensions. These multiple dimensions make wellness difficult to accurately assess as multiple subjective and objective measures are required to account for the different dimensions. Thus, the assessment of wellness in individuals may include a variety of factors, including assessment of physiologic functioning, anthropometry, happiness, depression, anxiety, mood, sleep, health symptoms, toxic load, neurocognitive function, socioeconomic status, social connectivity, and perceived self-efficacy.”

Sounds a bit woolly?

I agree! It sounds like a gimmick for getting at the cash of the gullible public.

Is there money to be made with ‘wellness’?

Sure! Lots!

For instance, with so-called ‘wellness retreats’.

Wellness retreats are all the rage. They use all sorts of bogus therapies within luxurious holiday settings for the ‘well to do’ end of our societies.

But is there any science behind this approach?

Few studies have evaluated the effect of retreat experiences, and no published studies have reported health outcomes. The objective of this new study therefore was to assess the effect of a week-long wellness-retreat experience in wellness tourists. The study was designed as a longitudinal observational study without a control group. Outcomes were assessed upon arrival and departure and 6 weeks after the retreat. The intervention was a ‘holistic, 1-week, residential, retreat experience that included many educational, therapeutic, and leisure activities and an organic, mostly plant-based diet’.

The outcome measures included anthropometric measures, urinary pesticide metabolites, a food and health symptom questionnaire, the Five Factor Wellness Inventory, the General Self Efficacy questionnaire, the Pittsburgh Insomnia Rating Scale, the Depression Anxiety Stress Scale, the Profile of Mood States, and the Cogstate cognitive function test battery.

Statistically significant improvements were seen in almost all measures after 1 week. Many of these improvements were also sustained at 6 weeks. There were statistically significant improvements in all anthropometric measures after 1 week, with reductions in abdominal girth, weight, and average systolic and diastolic pressure. Statistically significant improvements were also noted in psychological and health symptom measures. Urinary pesticide metabolites were detected in pooled urine samples before the retreat and were undetectable after the retreat.

The authors concluded that “the retreat experiences can lead to substantial improvements in multiple dimensions of health and well-being that are maintained for 6 weeks. Further research that includes objective biomarkers and economic measures in different populations is required to determine the mechanisms of these effects and assess the value and relevance of retreat experiences to clinicians and health insurers.”

IS THIS GOOD OR BAD RESEARCH?

Let’s apply my checklist from the previous post:

  • published in one of the many dodgy CAM journals? YES
  • single author? NO
  • authors are known to be proponents of the treatment tested? YES
  • author has previously published only positive studies of the therapy in question? YES
  • lack of plausible rationale for the study? YES
  • lack of plausible rationale for the therapy that is being tested? YES
  • stated aim of the study is ‘to demonstrate the effectiveness of…’ ? NO
  • stated aim ‘to establish the effectiveness AND SAFETY of…’? NO
  • text full of mistakes, e. g. spelling, grammar, etc.? NO
  • sample size is tiny? YES
  • pilot study reporting anything other than the feasibility of a definitive trial? NO
  • methods not described in sufficient detail? YES
  • mismatch between aim, method, and conclusions of the study? YES
  • results presented only as a graph? NO
  • statistical approach inadequate or not sufficiently detailed? NO
  • discussion without critical input? NO
  • lack of disclosures of ethics, funding or conflicts of interest? NO
  • conclusions which are not based on the results? YES

To me, this rough and ready assessment indicates that there are too many warning signals for characterising this as a rigorous study. It looks a lot like pseudo-science, I fear.

But these are at best formal markers. More important is the fact that the whole idea of measuring the effects of a ‘wellness retreat’ makes little sense, particularly in the absence of a control group. If we take a few people out of their usual, stressful work-environment and put them into a nice and luxurious holiday atmosphere where they get papered, eat better food, exercise more, sleep better and relax a lot – what would we expect after one week?

Yes, precisely! We would expect that almost anything measurable has changed for the better!

In fact, this result is so predictable that it is hardly worth documenting. Crucially, the outcome has very little to do with wellness, holism, or alternative medicine.

My conclusion: wellness not only attracts charlatans, entrepreneurs and windbags, it also is firmly steeped in pseudoscience.

 

 

 

One of the questions I hear frequently is ‘HOW CAN I BE SURE THIS STUDY IS SOUND’? Even though I have spent much of my professional life on this issue, I am invariably struggling to provide an answer. Firstly, because a comprehensive reply must inevitably have the size of a book, perhaps even several books. And secondly, to most lay people, the reply would be intensely boring, I am afraid.

Yet many readers of this blog evidently search for some guidance – so, let me try to provide a few indicators – indicators, not more!!! – as to what might signify a good and a poor clinical trial (other types of research would need different criteria).

INDICATORS SUGGESTIVE OF A GOOD CLINICAL TRIAL

  • Author from a respected institution.
  • Article published in a respected journal.
  • A clear research question.
  • Full description of the methods used such that an independent researcher could repeat the study.
  • Randomisation of study participants into experimental and control groups.
  • Use of a placebo in the control group where possible.
  • Blinding of patients.
  • Blinding of investigators, including clinicians administering the treatments.
  • Clear definition of a primary outcome measure.
  • Sufficiently large sample size demonstrated with a power calculation.
  • Adequate statistical analyses.
  • Clear presentation of the data such that an independent assessor can check them.
  • Understandable write-up of the entire study.
  • A discussion that puts the study into the context of all the important previous work in this area.
  • Self-critical analysis of the study design, conduct and interpretation of the results.
  • Cautious conclusion which are strictly based on the data presented.
  • Full disclosure of ethics approval and informed consent,
  • Full disclosure of funding sources.
  • Full disclosure of conflicts of interest.
  • List of references is up-to-date and includes also studies that contradict the authors’ findings.

I told you this would be boring! Not only that, but each bullet point is far too short to make real sense, and any full explanation would be even more boring to a lay person, I am sure.

What might be a little more fun is to list features of a clinical trial that might signify a poor study. So, let’s try that.

WARNIG SIGNALS INDICATING A POOR CLINICAL TRIAL

  • published in one of the many dodgy CAM journals (or in a book, blog or similar),
  • single author,
  • authors are known to be proponents of the treatment tested,
  • author has previously published only positive studies of the therapy in question (or member of my ‘ALT MED HALL OF FAME’),
  • lack of plausible rationale for the study,
  • lack of plausible rationale for the therapy that is being tested,
  • stated aim of the study is ‘to demonstrate the effectiveness of…’ (clinical trials are for testing, not demonstrating effectiveness or efficacy),
  • stated aim ‘to establish the effectiveness AND SAFETY of…’ (even large trials are usually far too small for establishing the safety of an intervention),
  • text full of mistakes, e. g. spelling, grammar, etc.
  • sample size is tiny,
  • pilot study reporting anything other than the feasibility of a definitive trial,
  • methods not described in sufficient detail,
  • mismatch between aim, method, and conclusions of the study,
  • results presented only as a graph (rather than figures which others can re-calculate),
  • statistical approach inadequate or not sufficiently detailed,
  • discussion without critical input,
  • lack of disclosures of ethics, funding or conflicts of interest,
  • conclusions which are not based on the results.

The problem here (as above) is that one would need to write at least an entire chapter on each point to render it comprehensible. Without further detailed explanations, the issues raised remain rather abstract or nebulous. Another problem is that both of the above lists are, of course, far from complete; they are merely an expression of my own experience in assessing clinical trials.

Despite these caveats, I hope that those readers who are not complete novices to the critical evaluation of clinical trials might be able to use my ‘warning signals’ as a form of check list that helps them to tell the chaff from the wheat.

Nobody really likes to be criticised; it can be painful. Painful but often necessary! Criticism produces progress. Criticism is therefore important. So, let’s think about criticism for a moment.

Obviously I am not talking of criticism such as ‘YOU ARE AN IDIOT’. In fact, that’s not criticism at all; it’s an insult. I am also not thinking about criticism like ‘YOUR ARGUMENT IS IDIOTIC’. I prefer to focus on criticism that is constructive, well-argued and based on evidence.

In healthcare, there is plenty of that type of criticism – luckily, I hasten to add. Its aim is to improve healthcare of the future. We need criticism to make progress. Without it, things come to a standstill or regress. This is why all the major medical journals are full of it, and many medical conferences are entirely or partly focussed on such aspects . For instance, frequently-cited papers in the BMJ, Lancet, NEJM, etc. point out that:

  • much of the current medical research is unreliable,
  • many therapies in current use have severe adverse effects,
  • patients frequently do not get the optimal treatment in a timely fashion,
  • modern medicine is too often inhumane.

The hope is that by disclosing these and many other deficits, appropriate actions can be found and taken to improve the situation and make progress. This process is hardly ever straight forward. All too often it is slow, inadequate and impeded by logistic and other obstacles. Therefore, it is crucial that constructive criticism continues to be voiced. Many clinicians, researchers and other experts have dedicated their lives to this very task.

Now, let’s look at the realm of alternative medicine.

There is certainly not less to criticise here than in conventional medicine. So, are all the journals of alternative medicine full of criticism of alternative medicine? Are there regular conferences focussed on criticism? Are alternative practitioners keen to hear about the weaknesses of their beliefs, practice, etc.?

The short answer is, no!

Yet, advocates of alternative medicine are, of course, not adverse to voicing criticism. In fact, they criticise almost non stop – at least this is the impression I get from reading their comments on this blog and from continually discussing with them since 1993.

But there is a fundamental difference: they criticise (often rightly) conventional medicine, and they criticise those (sometimes rightly) who criticise alternative medicine. When it comes to criticising their own practices, however, there is an almost deafening silence.

In my view, these differences between alternative and conventional medicine are far from trivial. In conventional medicine:

  • There is a long tradition of criticism.
  • Criticism is published and discussed prominently.
  • Criticism is usually well-accepted.
  • Criticism is often taken on board and appropriate action follows.
  • Criticism thus can and often does lead to progress.

By contrast, in alternative medicine almost nothing of the above ever happens. Criticism is directed almost exclusively towards those who are outside the realm. Criticism from the inside is as good as non-existent.

The consequences of this situation are easy to see for everyone, and they can be dramatic:

  • The journals of alternative medicine publish nothing that could be perceived to be negative for the practice of alternative medicine.
  • Self-critical thinking has no tradition and has remained an almost alien concept.
  • The very few people from the ‘inside’ who dare to criticise alternative practices are ousted and/or declared to be incompetent or worse.
  • No action is taken to initiate change.
  • The assumptions of alternative medicine remain unaltered for centuries.
  • Progress is all but absent.

It is time that the world of alternative medicine finally understands that constructive criticism is a necessary step towards progress!

Hyperthyroidism is, so I am told, a frequent veterinary problem, particularly in elderly cats. Homeopathic treatment is sometimes used to treat this condition. One article even provided encouraging details based on 4 case-reports. All 4 cats showed resolution of clinical signs; three attained normal thyroid hormone levels.  The authors concluded that homeopathic and complementary therapies avoid the potential side effects of methimazole and surgical thyroidectomy, they are less costly than radioactive iodine treatment, and they provide an option for clients who decline conventional therapies.

Yes, you guessed correctly: such a paper can only be published in the journal ‘HOMEOPATHY‘, respectable journals would not allow such conclusions based on 4 case-reports. They don’t permit inferences as to cause and effect. We have no idea what would have happened to these animals without homeopathy – perhaps they would have fared even better!

What we need is a proper controlled trial. The good news is that such a study has just been published. This double-blinded, placebo-controlled randomised trial was aimed at testing the efficacy of individualised homeopathy in the treatment of feline hyperthyroidism. Cats were randomised into two treatment arms. Either a placebo or a homeopathic treatment was given to each cat blindly.

After 21 days, the T4 levels, weight (Wt) and heart rate (HR) were compared with pre-treatment values. There were no statistically significant differences in the changes seen between the two treatment arms following placebo or homeopathic treatment, or between the means of each parameter for either treatment arm before and after placebo or homeopathic treatment. In a second phase of the study, patients in both treatment arms were given methimazole treatment for 21 days and T4, Wt and HR determined again. Subsequently, statistically significant reductions were noted in T4 (P<0.0001) and HR (P=0.02), and a statistically significant increase was observed in Wt (P=0.004).

The authors concluded that the results of this study failed to provide any evidence of the efficacy of homeopathic treatment of feline hyperthyroidism.

So, homeopathy does not work – not in humans nor in animals. This statement, backed by solid facts, proves all those wrong who cannot resist uttering the notion that HOMEOPATHY CANNOT BE A PLACEBO BECAUSE IT WORKS IN ANIMALS.

It doesn’t!

And we have seen the evidence for the correctness of this fact so often (for instance here, here, here and here) that I feel embarrassed to say it again: highly diluted homeopathic remedies are placebos. As soon as we adequately control for placebo and other non-specific effects in properly controlled studies, the alleged effects, reported in anecdotes and other uncontrolled studies, simply disappear.

 

I am sure this  FDA press-release will interest many readers (we reported about this case before):

The U.S. Food and Drug Administration announced today that its laboratory analysis found inconsistent amounts of belladonna, a toxic substance, in certain homeopathic teething tablets, sometimes far exceeding the amount claimed on the label. The agency is warning consumers that homeopathic teething tablets containing belladonna pose an unnecessary risk to infants and children and urges consumers not to use these products.

In light of these findings, the FDA contacted Standard Homeopathic Company in Los Angeles, the manufacturer of Hyland’s homeopathic teething products, regarding a recall of its homeopathic teething tablet products labeled as containing belladonna, in order to protect consumers from inconsistent levels of belladonna. At this time, the company has not agreed to conduct a recall. The FDA recommends that consumers stop using these products marketed by Hyland’s immediately and dispose of any in their possession. In November 2016, Raritan Pharmaceuticals (East Brunswick, New Jersey) recalled three belladonna-containing homeopathic products, two of which were marketed by CVS.

“The body’s response to belladonna in children under two years of age is unpredictable and puts them at unnecessary risk,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research. ”We recommend that parents and caregivers not give these homeopathic teething tablets to children and seek advice from their health care professional for safe alternatives.”

Homeopathic teething products have not been evaluated or approved by the FDA for safety or effectiveness. The agency is unaware of any proven health benefit of the products, which are labeled to relieve teething symptoms in children. In September 2016, the FDA warned against the use of these products after receiving adverse event reports.

Consumers should seek medical care immediately if their child experiences seizures, difficulty breathing, lethargy, excessive sleepiness, muscle weakness, skin flushing, constipation, difficulty urinating, or agitation after using homeopathic teething products.

The FDA encourages health care professionals and consumers to report adverse events or quality problems experienced with the use of homeopathic teething products to the FDA’s MedWatch Adverse Event Reporting program:

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The Agency is also responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

END OF PRESS RELEASE

Well, this will be irritating to many homeopathy-fans, not least to our friend Dana Ullman. He likes to publish articles alleging that the US authorities have recently taken to being ever so unfair to the homeopathic industry. I commented recently on his paper entitled “Extreme Bias in FTC’s Ruling on Homeopathic Medicine” where he displays the well-known biases and ignorance of his trade in exemplary fashion, including the often firm anti-vaccination stance of homeopaths. Dana can also not resist claiming that ‘the Swiss government’s “Health Technology Assessment” on homeopathic medicine is much more comprehensive than any previous governmental report written on this subject to date’ and – how could it be otherwise? – is sufficient proof that homeopathy works.

In case you believe in what Ullman says, you ought to read the intriguing evidence about Ullman after being called as an expert witness in an US class action. On this occasion, the judge stated:

The Defendant presented the testimony of Gregory Dana Ullman who is a homeopathic practitioner. He outlined the theory of homeopathic treatment and presented his opinion as to the value and effectiveness of homeopathic remedies. The Court found Mr. Ullman’s testimony to be not credible. Mr. Ullman’s bias in favor of homeopathy and against conventional medicine was readily apparent from his testimony. He admitted that he was not an impartial expert but rather is a passionate advocate of homeopathy. He posted on Twitter that he views conventional medicine as witchcraft. He opined that conventional medical science cannot be trusted.
[…]
Mr. Ullman’s testimony was unhelpful in understanding the purported efficacy of the ingredients of SnoreStop to reduce the symptoms of snoring. Although he is familiar with the theory of homeopathic treatment, his opinions regarding its effectiveness was unsupported and biased. The Court gave no weight to his testimony.(Rosendez v. Green Pharmaceuticals)

Say no more!

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