MD, PhD, FMedSci, FSB, FRCP, FRCPEd

bogus claims

1 2 3 30

Homeopathy must be effective! It is used extensively throughout the world, not least India! If it were ineffective, as all these nasty sceptics insist, Indians would not use it in such large numbers.

How often have we heard this argument?

Take, for instance, statements from the ‘peer-reviewed’ literature such as this one: “At present, in India, homeopathy is the third most popular method of medical treatment after allopathy and Ayurveda. There are over 200,000 registered homeopathic doctors currently, with approximately 12,000 more being added every year.” Or take statements from UK homeopaths like this one: “It seems clear that homeopathy is there to stay in India. So next time you see or read some condescending and patronising rubbish about homeopathy in the media, know that in India, a country with a population of 1.2 billion people (that’s more than 20x the population of the UK) homeopathy is an integral part of the healthcare system and deeply respected by the people of that country.”

Yes, homeopaths have always loved to mislead the public with fallacies!

The appeal to popularity is, of course, a classic fallacy – but, in the case of homeopathy’s popularity in India, it is not just that; here is an intriguing aspect to the use of homeopathy in that country that shines a different light on the whole story.

Epidemiologists from Canada conducted semi-structured interviews of 175 Mumbai slum-based practitioners holding degrees in Ayurveda, homeopathy and Unani. Most providers gave multiple interviews. The researchers also observed 10 providers in clinical interactions, documenting clinical examinations, symptoms, history taking, prescriptions and diagnostic tests.

No practitioners exclusively used his or her system of training. The practice of biomedicine was frequent, with practitioners often using biomedical disease categories and diagnostics. The use of homeopathy was rare; only 4% of consultations with homeopaths resulted in the prescription of homeopathic remedies.

The authors concluded that important sources of health care in Mumbai’s slums, AYUSH physicians frequently use biomedical therapies and most refer patients with TB to chest physicians or the public sector. They are integral to TB care and control.

These data seem to suggest that the use of homeopathic remedies in India is far, far less than often claimed by apologists. Indian homeopaths seem to have much more sense than to use homeopathy for serious conditions. This is good news for Indian public health, in my view.

The story also shows how the ‘appeal to popularity’ is being misused for the promotion of homeopathy: not only is it based on poor logic but often also on false information.

I am sure that most of us have had enough of the endless discussions, information and foremost disinformation about Brexit; we truly had to endure them ad nauseam. And here I come with a post about the very subject.

Have I lost my senses?

Bear with me and find out for yourself.

There has been little mention of alternative medicine in the debates about last week’s referendum. For the Remain campaigners, there was perhaps no reason to go into this divisive topic because, in their view, all would stay as it is. And the ‘Brexiters’ obviously had other things on their minds. It seemed almost as though they were too busy inventing new lies on a daily basis. To me, it seems fairly obvious though that, in the realm of alternative medicine, quite a lot could change after disastrous vote to leave the EU .

My main fears are twofold;

  1. Politicians who are short-sighted enough to campaign for Brexit might also be sufficiently stupid to go for unproven medicine. This fear seems to be confirmed by Nigel Farage who once claimed that BIG HARMA was lobbying in Brussels to put alternative medicine producers out of business. But we should take that with a pinch of salt, of course; anything this man says is hardly worth taking any notice of, in my view.
  2. Consumers who are gullible enough to believe the false arguments of the Brexiters might also be sufficiently naïve to believe the fallacies and falsehoods of alternative medicine promoters.

So, are there reasonable predictions as to how Brexit might impact on the alternative medicine scene in Britain? I searched for some evidence on this question and was surprised how little there was to be found.

Dr Jan Knight from Knight Scientific, a medical research company, was quoted saying: “A lot of the complementary/alternative medicine lobby are rubbing their hands because they think they’ll be able to do anything, but I don’t think the regulations will change.”

The excellent QUACKOMETER published an entire article on the subject which is well worth reading and essentially agrees with this view. Here are its conclusions: “EU laws about alternative medicine are not that great in number. The UK is free to choose who it licenses as a medical practitioner. It can allow chiropractors and osteopaths to have statutory regulation and does so. It can fund any such treatment publicly if it so wished without EU interference. It can police the sale of products on the High Street by funding Trading Standards and training them (but it chooses not to.) The UK government can come up with its own schemes to register herbalists and homeopaths and in doing so misleads the public about them. In short, it is possible to suggest that the UK governments do indeed exercise sovereignty over how alternative medicine manifests itself, how well the public is protected and how much public money is spent on it. Leaving the EU is not going to make much difference that way. Although I do suspect that staying might indeed over the years steadily increase the level of regulation around the matter. Successive UK governments have not done a lot. The EU just a little more.”

Perhaps the regulatory framework might not change a lot. But what about the prevalence of alternative medicine usage? It seems difficult to predict in which direction it will go. The reason is that I see influences in both directions.

FACTORS THAT COULD INCREASE THE USE OF ALTERNATIVE MEDICINE

The Brexiters managed to style themselves as the anti-establishment. It is obvious that much of alternative medicine understands itself as an anti-establishment movement within healthcare. This means there could be a natural affinity between the two. On second thought, however, I think we can reject this possibility. The reason is that the Brexiters’ anti-establishment stance was nothing but a campaign ploy; in truth it is as genuine as a 4£ note.

What is much more real, in my view, is the well-documented inability of the Brexiters to correctly interpret the evidence (one could put this more simply by pointing out their ability to twist and turn the truth such that it suits their aims). These are qualities which I have often observed in promoters of alternative medicine, and it is this type of affinity that eventually might stimulate a general upwards trend of alternative medicine in the UK.

In a similar vein, we have to account for the influence of our future king. Prince Charles clearly has an alternative bee under his bonnet. Once we are outside the EU, it is likely that his influence on health politicians and other decision makers will be felt more powerfully. The Prince of Wales might even revive the ‘Smallwood Report’ which he commissioned to convince politicians that money could be saved by using more alternative therapies in the NHS. Charles and his views usually generate bewilderment on the EU-level, while here in the UK we still have many who take him seriously. His influence in a post-Brexit Britain is likely to be strengthened and will therefore be a factor that has the potential to boost alternative medicine in the UK.

FACTORS THAT COULD DECREASE THE USE OF ALTERNATIVE MEDICINE

It has been reported that our suicidal move out of the EU has led to a contraction of wealth in Britain which is bigger than anything seen since 1921. Apparently, £ 120 billion have been wiped off the value of the stock market within just a few hours. To assume that this will hit only those who are rich enough to own shares, is more than naïve. It will hit all Brits and might even drive us into another recession.

Such developments are, of course, most unwelcome but nevertheless important in relation to alternative medicine usage. Those who employ alternative treatments usually pay for them out of their own pocket. Alternative medicine has always been a bit of a luxury item for those who had more money than sense. The consequence is that financially hard times are almost automatically associated with a reduction of alternative medicine use.

CONCLUSION

All of this is, of course, akin to an exercise in reading tea leafs. But if I am correct, we will now see a significant decrease in the demand for alternative medicine in the ‘Disunited Kingdom’. Once the financial misery is over – and that could take many years – Prince Charles and other ‘irrationalists’ might succeed in bringing about a moderate increase in the use of unproven treatments.

Turmeric (Curcuma longa) is a truly fascinating plant with plenty of therapeutic potential. It belongs to the ginger family, Zingiberaceae and is native to southern Asia. Its main active ingredients are curcumin (diferuloylmethane) and the related compounds, demethoxycurcumin and bis-demethoxycurcumin (curcuminoids) which are secondary metabolites. Turmeric  has been used extensively in Ayurvedic medicine and has a variety of pharmacologic properties including antioxidant, analgesic, anti-inflammatory, and antiseptic activities.

In the often weird world of alternative medicine, turmeric is currently being heavily hyped as the new panacea. Take this website, for instance; it promotes turmeric for just about any ailment known to mankind. Here is a short excerpt to give you a flavour (pun intended, turmeric is, of course, a main ingredient in many curries):

It comes at a surprise to a lot of people that herbs can be highly effective, if not more effective, than conventional medications …

To date, turmeric is one of the top researched plants. It was involved in more than 5,600 peer-reviewed and published biomedical studies. In one research project that extended over a five year period, it was found that turmeric could potentially be used in preventive and therapeutic applications. It was also noted that it has 175 beneficial effects for psychological health…

The 14 Medications it Mimics

Or should we say the 14 medications that mimic turmeric, since turmeric has been around much longer than any chemical prescription drug. Here’s a quick look at some of them:

  • Lipitor: This is a cholesterol drug that is used to reduce inflammation and oxidative stress inside of patients suffering from type 2 diabetes. When the curcuminoid component inside of turmeric is properly prepared, it can offer the same effects (according to a study published in 2008).
  • Prozac: This is an antidepressant that has been overused throughout the past decade. In a study published back in 2011, turmeric was shown to offer beneficial effects that helped to reduce depressive behaviors (using animal models).
  • Aspirin: This is a blood thinner and pain relief drug. In a study done in 1986, it was found that turmeric has similar affects, which makes it a candidate for patients that are susceptible to vascular thrombosis and arthritis.
  • Metformin: This is a drug that treats diabetes. It is used to activate AMPK (to increase uptake of glucose) and helps to suppress the liver’s production of glucose. In a study published in 2009, it was found that curcumin was 500 to 100,000 times more effective at activating AMPK ad ACC.
  • Anti-Inflammatory Drugs: This includes medications like ibuprofen, aspirin and dexamethasone, which are designed to reduce inflammation. Again, in 2004, it was proven that curcumin was an effective alternative option to these chemical drugs.
  • Oxaliplatin: This is a chemotherapy drug. A study done in 2007 showed that curcumin is very similar to the drug, acting as an antiproliferative agent in colorectal cell lines.
  • Corticosteroids: This is a steroid medication, which is used to treat inflammatory eye diseases. In 1999, it was found that curcumin was effective at managing this chronic condition. Then in 2008, curcumin was used in an animal model that proved it could also aid in therapy used to protect patients from lung transplantation-associated injuries by “deactivating” inflammatory genes.

Turmeric Fights Drug-Resistant Cancers… it’s been shown that curcumin can battle against cancers that are resistant to chemotherapy and radiation…

END OF QUOTE

As I said, turmeric is fascinating and promising, but such hype is clearly counter-productive and dangerous. As so often, the reality is much more sobering than the fantasy of uncritical quacks. Research is currently very active and has produced a host of interesting findings. Here are the conclusions (+links) of a few, recent reviews:

Overall, there is early evidence that turmeric/curcumin products and supplements, both oral and topical, may provide therapeutic benefits for skin health. However, currently published studies are limited and further studies will be essential to better evaluate efficacy and the mechanisms involved.

This meta-analysis of RCTs suggested a significant effect of curcumin in lowering circulating TNF-α concentration.

While statistical significant differences in outcomes were reported in a majority of studies, the small magnitude of effect and presence of major study limitations hinder application of these results.

Overall, scientific literature shows that curcumin possesses anti-diabetic effects and mitigates diabetes complications.

The highlighted studies in the review provide evidence of the ability of curcumin to reduce the body’s natural response to cutaneous wounds such as inflammation and oxidation. The recent literature on the wound healing properties of curcumin also provides evidence for its ability to enhance granulation tissue formation, collagen deposition, tissue remodeling and wound contraction. It has become evident that optimizing the topical application of curcumin through altering its formulation is essential to ensure the maximum therapeutical effects of curcumin on skin wounds.

What emerges from a critical reading of the evidence is that turmeric has potential in several different areas. Generally speaking, clinical trials are still thin on the ground, not of sufficient rigor and therefore not conclusive. In other words, it is far too early to state or imply that we all should rush to the next health food store and buy the supplements.

On the contrary, at this stage, I would even warn people not to be seduced by the unprofessional hype and wait until we know more – much more. There might be risks associated with ingesting turmeric at high doses over long periods of time. And there are fundamental open questions about oral intake. One recent review cautioned: …its extremely low oral bioavailability hampers its application as therapeutic agent.

WATCH THIS SPACE!

Homeopaths assume lots of things; one of their main claims is, for instance, that the process of repeatedly diluting a remedy and vigorously shaking it at each step – they call this potentisation – renders it more potent. This is the famous MEMORY OF WATER’ theory of homeopathy. In Hahnemann’s own words: ‘…the power of a medicine in solution is much increased by intimate mixture with a large volume of fluid…’ And elsewhere he stated that ‘as the smallest quantity of medicine naturally disturbs the organism least, we should choose the very smallest doses, provided always that they are a match for the disease… hardly any dose of the homeopathically selected remedy can be so small as not to be stronger than the natural disease…’

Hahnemann’s explanation for this extraordinary assumption (which he claimed to have observed empirically) was that his remedies do not work through any material effects but via spirit-like energies. As this sounds a little silly in the light of modern science, homeopaths have been keen to find more rational support for their theories. Thus they have developed several ‘sciency’ concepts to explain the mode of action of their highly diluted homeopathic remedies. For instance that postulated that water can form secondary structures that hold some information of the original substance (stock), even if it has long been diluted out of the remedy. Alternatively, they claimed that the shaking of the remedy generates nano-particles or silicone-particles which, in turn, are the cause of the clinical effects.

Today, I want to assume for a minute, that one of these theories is correct – they cannot all be right, of course. Homeopaths regularly show us investigations that seem to support them, even though it only needs a real expert in the particular field of science to cast serious doubt on them. I will nevertheless assume that, after potentisation, the diluent retains information via nano-particles or some other phenomenon. For the purpose of this mind-experiment, I grant homeopaths that, in this respect, they are correct. In other words, let’s for a moment assume that the ‘memory of water’ theory is correct.

As I have been more than generous, I want homeopaths to return the favour and consider what this would really mean: information has been transferred from the stock to the diluent. Does that prove anything? Does it show that homeopathy is valid?

Could the homeopaths who make this assumption be equally generous and answer the following questions, please?

  1. How does a nano-particle of coffee, for instance, affect the sleep centre in the brain to make the patient sleep? Or how does a nano-particle of the Berlin Wall or a duck liver affect anything at all in the human body? The claim that information has been retained by the diluent is no where near to an explanation of a rational mode of action, isn’t it?
  2. Most homeopathic remedies are consumed not as liquids but as ‘globuli’, i. e.  tiny little pills made of lactose. They are prepared by dropping the liquid remedy on to them. The liquid subsequently evaporates. How is it that the information retained in the liquid does not evaporate with the diluent?
  3. The diluent usually is a water-alcohol mixture which inevitably contains impurities. In fact, a liquid C12 remedy most certainly contains dimensions more impurities than stock. These impurities have, of course, also been vigorously shaken, i. e. potentised. How can we explain that their ‘potency’ has not been beefed up at each dilution step? Would this not necessitate a process where only some molecules in the diluent are agitated, while all the rest remain absolutely still? How can we explain this fantastic concept?
  4. Some stock used in homeopathy is insoluble (for instance Berlin Wall). Such stock is not diluted but its concentration in the remedy is initially lowered by a process called ‘trituration’, a process which consists in grinding the source material in another solid material, usually lactose. I have granted you that potentisation works in the way you think. But how is information transferred from one solid material to another?
  5. Everything we drink is based on water containing molecules that have been inadvertently potentised in nature a million times and therefore should have hugely powerful effects on our bodies. How is it that we experience none of these effects each time we drink?

Now, homeopaths, let me propose a deal.

If you can answer these questions satisfactorily, I will no longer doubt your memory of water theory. If you cannot do this, I think you ought to admit that all your ‘sciency’ theories about the mode of action of highly diluted homeopathic remedies are really quite silly – more silly even than Hahnemann’s idea of a ‘spirit-like’ effect.

 

The ACUPUNCTURE NOW FOUNDATION (ANF) have recently published a document that is worth drawing your attention to. But first I should perhaps explain who the ANF are. They state that “The Acupuncture Now Foundation (ANF) was founded in 2014 by a diverse group of people from around the world who were concerned about common misunderstandings regarding acupuncture and wanted to help acupuncture reach its full potential. Our goal is to become recognized as a leader in the collection and dissemination of unbiased and authoritative information about all aspects of the practice of acupuncture.”

This, I have to admit, sounds like music to my ears! So, I studied the document in some detail – and the music quickly turned into musac.

The document which they call a ‘white paper’ promises ‘a review of the research’. Reading even just the very first sentence, my initial enthusiasm turned into bewilderment: “It is now widely accepted across health care disciplines throughout the world that acupuncture can be effective in treating such painful conditions as migraine headaches, and low back, neck and knee pain, as well as a range of painful musculoskeletal conditions.” Any review of research that starts with such a deeply uncritical and overtly promotional statement, must be peculiar (quite apart from the fact that the ANF do not seem to appreciate that back and neck pain are musculoskeletal by nature).

As I read on, my amazement grew into bewilderment. Allow me to present a few further statements from this review (together with a link to the article provided by the ANF in support and a very brief comment by myself) which I found more than a little over-optimistic, far-fetched or plainly wrong:

Male fertility, especially sperm production and motility, has also been shown to improve with acupuncture. In a recent animal study, electro-acupuncture was found to enhance germ cell proliferation. This action is believed to facilitate the recovery of sperm production (spermatogenesis) and may restore normal semen parameters in subfertile patients.

The article supplied as evidence for this statement refers to an animal experiment using a model where sperm are exposed to heat. This has almost no bearing on the clinical situation in humans and does not lend itself to any clinical conclusions regarding the treatment of sub-fertile men.

In a recent meta-analysis, researchers concluded that the efficacy of acupuncture as a stand-alone therapy was comparable to antidepressants in improving clinical response and alleviating symptom severity of major depressive disorder (MDD). Also, acupuncture was superior to antidepressants and waitlist controls in improving both response and symptom severity of post-traumatic stress disorder (PTSD). The incidence of adverse events with acupuncture was significantly lower than antidepressants.

The review provided as evidence is wide open to bias; it was criticised thus: “the authors’ findings did not reflect the evidence presented and limitations in study numbers, sample sizes and study pooling, particularly in some subgroup analyses, suggested that the conclusions are not reliable”. Moreover, we need to know that by no means all reviews of the subject confirm this positive conclusion, for instance, thisthis, or this one; all of the latter reviews are more up-to-date than the one provided by ANF. Crucially, a Cochrane review concluded that “the evidence is inconclusive to allow us to make any recommendations for depression-specific acupuncture”.

“A randomized controlled trial of acupuncture and counseling for patients presenting with depression, after having consulted their general practitioner in primary care, showed that both interventions were associated with significantly reduced depression at three months when compared to usual care alone.”

We have discussed the trial in question on this blog. It follows the infamous ‘A+B versus B’ design which cannot possibly produce a negative result.

Now, please re-read the first paragraph of this post; but be careful not to fall off your chair laughing.

There would be more (much more) to criticise in the ANF report but, I think, these examples are ENOUGH!

Let me finish by quoting from the ANF’s view on the future as cited in their new ‘white paper’: “Looking ahead, it is clear that acupuncture is poised to make significant inroads into conventional medicine. It has the potential to become a part of every hospital’s standard of care and, in fact, this is already starting to take place not only in the U.S., but internationally. The treatment is a cost-effective and safe method of relieving pain in emergency rooms, during in-patient stays and after surgery. It can lessen post-operative nausea, constipation and urinary difficulties, and have a positive impact on conditions like hypertension, anxiety and insomnia…

Driven by popular demand and a growing body of scientific evidence, acupuncture is beginning to be taken seriously by mainstream conventional medicine, which is incorporating it into holistic health programs for the good of patients and the future of health care. In order for this transition to take place most effectively, misunderstandings about acupuncture need to be addressed. We hope this white paper has helped to clarify some of those misunderstandings and encourage anyone with questions to contact the Acupuncture Now Foundation.”

My question is short and simple: IGNORANCE OR FRAUD?

 

Yes, yes, yes, I know: we have too few women in our ‘ALT MED HALL OF FAME’. This is not because I have anything against them (quite the contrary) but, in alternative medicine research, the boys by far outnumber the girls, I am afraid.

You do remember, of course, you has previously been admitted to this austere club of excellence; only two women so far. Here is the current list of members to remind you:

David Peters (osteopathy, homeopathy, UK)

Nicola Robinson (TCM, UK)

Peter Fisher (homeopathy, UK)

Simon Mills (herbal medicine, UK)

Gustav Dobos (various, Germany)

Claudia Witt (homeopathy, Germany and Switzerland)

George Lewith (acupuncture, UK)

John Licciardone (osteopathy, US)

If you study the list carefully, you will also notice that, until now, I have totally ignored the chiropractic profession. This is a truly embarrassing omission! When it comes to excellence in research, who could possibly bypass our friends, the chiropractors?

Today we are going to correct these mistakes. Specifically, we are going to increase the number of women by 50% (adding one more to the previous two) and, at the same time, admit a deserving chiropractor to the ALT MED HALL OF FAME.

Cheryl Hawk is currently the Executive Director of Northwest Center for Lifestyle and Functional Medicine, University of Western States, Portland, USA. Previously she worked as Director of Clinical Research at the Logan University College of Chiropractic, Chesterfield, USA, and prior to that she was employed at various other institutions. Since many years she has been a shining light of chiropractic research. She is certainly not ‘small fry’ when it comes to the promotion of chiropractic.

Cheryl seems to prefer surveys as a research tool over clinical trials, and it was therefore not always easy to identify those of her 67 Medline-listed articles that reported some kind of evaluation of the value of chiropractic. Here are, as always, the 10 most recent papers where I could extract something like a data-based conclusion (in bold) from the abstract.

Best Practices for Chiropractic Care of Children: A Consensus Update.

Hawk C, Schneider MJ, Vallone S, Hewitt EG.

J Manipulative Physiol Ther. 2016 Mar-Apr;39(3):158-68

All of the seed statements in this best practices document achieved a high level of consensus and thus represent a general framework for what constitutes an evidence-based and reasonable approach to the chiropractic management of infants, children, and adolescents.

Clinical Practice Guideline: Chiropractic Care for Low Back Pain.

Globe G, Farabaugh RJ, Hawk C, Morris CE, Baker G, Whalen WM, Walters S, Kaeser M, Dehen M, Augat T.

J Manipulative Physiol Ther. 2016 Jan;39(1):1-22

The evidence supports that doctors of chiropractic are well suited to diagnose, treat, co-manage, and manage the treatment of patients with low back pain disorders.

The Role of Chiropractic Care in the Treatment of Dizziness or Balance Disorders: Analysis of National Health Interview Survey Data.

Ndetan H, Hawk C, Sekhon VK, Chiusano M.

J Evid Based Complementary Altern Med. 2016 Apr;21(2):138-42.

The odds ratio for perceiving being helped by a chiropractor was 4.36 (95% CI, 1.17-16.31) for respondents aged 65 years or older; 9.5 (95% CI, 7.92-11.40) for respondents reporting head or neck trauma; and 13.78 (95% CI, 5.59-33.99) for those reporting neurological or muscular conditions as the cause of their balance or dizziness.

US chiropractors’ attitudes, skills and use of evidence-based practice: A cross-sectional national survey.

Schneider MJ, Evans R, Haas M, Leach M, Hawk C, Long C, Cramer GD, Walters O, Vihstadt C, Terhorst L.

Chiropr Man Therap. 2015 May 4;23:16.

American chiropractors appear similar to chiropractors in other countries, and other health professionals regarding their favorable attitudes towards EBP, while expressing barriers related to EBP skills such as research relevance and lack of time. This suggests that the design of future EBP educational interventions should capitalize on the growing body of EBP implementation research developing in other health disciplines. This will likely include broadening the approach beyond a sole focus on EBP education, and taking a multilevel approach that also targets professional, organizational and health policy domains.

Chiropractic identity, role and future: a survey of North American chiropractic students.

Gliedt JA, Hawk C, Anderson M, Ahmad K, Bunn D, Cambron J, Gleberzon B, Hart J, Kizhakkeveettil A, Perle SM, Ramcharan M, Sullivan S, Zhang L.

Chiropr Man Therap. 2015 Feb 2;23(1):4

The chiropractic students in this study showed a preference for participating in mainstream health care, report an exposure to evidence-based practice, and desire to hold to traditional chiropractic theories and practices. The majority of students would like to see an emphasis on correction of vertebral subluxation, while a larger percent found it is important to learn about evidence-based practice. These two key points may seem contradictory, suggesting cognitive dissonance. Or perhaps some students want to hold on to traditional theory (e.g., subluxation-centered practice) while recognizing the need for further research to fully explore these theories. Further research on this topic is needed.

Do informed consent documents for chiropractic clinical research studies meet readability level recommendations and contain required elements: a descriptive study.

Twist E, Lawrence DJ, Salsbury SA, Hawk C.

Chiropr Man Therap. 2014 Dec 10;22(1):40

These results strongly suggest that chiropractic clinical researchers are not developing ICDs at a readability level congruent with the national average acceptable level. The low number of elements in some of the informed consent documents raises concern that not all research participants were fully informed when given the informed consent, and it may suggest that some documents may not be in compliance with federal requirements. Risk varies among institutions and even within institutions for the same intervention.

Feasibility of using a standardized patient encounter for training chiropractic students in tobacco cessation counseling.

Hawk C, Kaeser MA, Beavers DV.

J Chiropr Educ. 2013 Fall;27(2):135-40.

This active learning exercise appeared to be a feasible way to introduce tobacco counseling into the curriculum.

Consensus process to develop a best-practice document on the role of chiropractic care in health promotion, disease prevention, and wellness.

Hawk C, Schneider M, Evans MW Jr, Redwood D.

J Manipulative Physiol Ther. 2012 Sep;35(7):556-67

This living document provides a general framework for an evidence-based approach to chiropractic wellness care.

Chiropractic or osteopathic manipulation for children in the United States: an analysis of data from the 2007 National Health Interview Survey.

Ndetan H, Evans MW Jr, Hawk C, Walker C.

J Altern Complement Med. 2012 Apr;18(4):347-53.

C/OM is primarily used for back and neck pain, which is increasing in prevalence in children. Teens are more likely to use it than are younger children.

The role of chiropractic care in older adults.

Dougherty PE, Hawk C, Weiner DK, Gleberzon B, Andrew K, Killinger L.

Chiropr Man Therap. 2012 Feb 21;20(1):3.

Given the utilization of chiropractic services by the older adult, it is imperative that providers be familiar with the evidence for and the prudent use of different management strategies for older adults.

I am pleased to say that Prof Hawk gave me no problems at all; her case is clear: she is a champion of using research as a means for promoting chiropractic, has published many papers in this vein, clearly prefers the journals of chiropractic that nobody other than chiropractors ever access, and has an impeccable track record when it comes to avoiding negative conclusions which could harm chiropractic in any way.

Very well done indeed!

WELCOME, PROF HAWK, TO THE ‘ALT MED HALL OF FAME’.

 

We tend to trust charities; many of us donate to charities; we think highly of the work they do and the advice they issue. And why shouldn’t we? After all, a ‘charity’ is ‘an institution or organization set up to provide help, money, etc, to those in need’. Not a hint at anything remotely sinister here – charities are good!

Except, of course, those that are not so good!

By ‘not so good’ I mean charities that misinform the public to a point where they might even endanger our health, well-being and savings. Yes, I am speaking of those charities that promote unproven or disproven alternative therapies – and unfortunately, there are many of those around today.

Our recent letter in the SUNDAY TIMES, tried to alert the public to this problem and to the fact that the UK regulator seems to be failing to do much about it. A Charity Commission spokesman, in turn, replied that his organisation had received the letter and would respond formally to it:

“The Commission is required to register organisations as charities which are established for exclusively charitable purposes for the public benefit,” he said. “Charitable purposes for the advancement of health include conventional methods as well as complementary, alternative or holistic methods which are concerned with healing mind, body and spirit in the alleviation of symptoms and the cure of illness. Those organisations dealing with complementary and alternative medicines must be able to demonstrate that they are capable of promoting health otherwise they will not be for the public benefit.

“The Commission is the registrar and regulator of charities however it is not the authority in the efficacy of any and every non-traditional medical treatment. These are issues of substantial debate with a variety of opinions. Each case is considered on its merits based on the evidence available. To be charitable there needs to be sufficient evidence of the efficacy of the method to be used. The Commission must further be assured that any potential harm that might be said to arise does not outweigh the benefit identified by the method.

“The Commission expects charities to provide information that is factually accurate with legitimate evidence.” 

But is the information provided by all charities factually accurate?

Take, for instance, YES TO LIFE! Have a good look and then decide for yourself.

On their website they state: “We provide support, information and financial assistance to those with cancer seeking to pursue approaches that are currently unavailable on the NHS. We also run a series of educational seminars and workshops which are aimed at the general public who want to know more and practitioners working with people who have cancer.”

The website informs us about many alternative therapies and directly or indirectly promote them for the curative or supportive treatment of cancer. I have chosen 5 of them and copied the respective summaries as published by YES TO LIFE. My main selection criterion was having done some research myself on the modality in question. Here are the 5 cancer treatments which I selected; the text from YES TO LIFE is in bold, and that of my published research is in normal print with a link to the published paper:

CARCTOL

Carctol is a relatively inexpensive product, specifically formulated to assist cells with damaged respiration, it is also a powerful antioxidant that targets free radicals, the cause of much cellular damage. It also acts to detoxify the system.

The claim that Carctol is of any benefit to cancer patients is not supported by scientific evidence.

LAETRILE

Often given intravenously as part of a programme of Metabolic Therapy, Laetrile is a non-toxic extract of apricot kernels. The claimed mechanism of action that is broken down by enzymes found in cancer cells. Hydrogen cyanide, one of the products of this reaction then has a local toxic effect on the cells.

The claims that laetrile or amygdalin have beneficial effects for cancer patients are not currently supported by sound clinical data. There is a considerable risk of serious adverse effects from cyanide poisoning after laetrile or amygdalin, especially after oral ingestion. The risk-benefit balance of laetrile or amygdalin as a treatment for cancer is therefore unambiguously negative.

MISTLETOE

Mistletoe therapy was developed as an adjunct to cancer treatment in Switzerland in 1917-20, in the collaboration between Dr I Wegman MD and Dr Rudolf Steiner PhD (1861-1925). Mistletoe extracts are typically administered by subcutaneous injection, often over many years. Mistletoe treatment improves quality of life, supports patients during recommended conventional cancer treatments and some studies show survival benefit. It is safe and has no adverse interactions with conventional cancer treatments.

None of the methodologically stronger trials exhibited efficacy in terms of quality of life, survival or other outcome measures. Rigorous trials of mistletoe extracts fail to demonstrate efficacy of this therapy.

UKRAIN

A type of low toxicity chemotherapy derived from a combination of two known cytotoxic drugs that are of little use individually, as the doses required for effective anticancer action are too high to be tolerated. However the combination is effective at far lower doses, with few side effects.

The data from randomised clinical trials suggest Ukrain to have potential as an anticancer drug. However, numerous caveats prevent a positive conclusion, and independent rigorous studies are urgently needed. [To judge the validity of this last treatment, I also recommend reading a previous post of mine.]

Finally, it might be informative to see who the individuals behind YES TO LIFE are. I invite you to have a look at their list of medical advisors which, I think, speaks for itself. It includes, for instance, Dr Michael Dixon of whom we have heard before on this blog, for instance, here, here and here.

Say no more!

This post is dedicated to Mel Koppelman.

Those who followed the recent discussions about acupuncture on this blog will probably know her; she is an acupuncturist who (thinks she) knows a lot about research because she has several higher qualifications (but was unable to show us any research published by herself). Mel seems very quick in lecturing others about research methodology. Yesterday, she posted this comment in relation to my previous post on a study of aromatherapy and reflexology:

Professor Ernst, This post affirms yet again a rather poor understanding of clinical trial methodology. A pragmatic trial such as this one with a wait-list control makes no attempt to look for specific effects. You say “it is quite simply wrong to assume that this outcome is specifically related to the two treatments.” Where have specific effects been tested or assumed in this study? Your statement in no way, shape or form negates the author’s conclusions that “aromatherapy massage and reflexology are simple and effective non-pharmacologic nursing interventions.” Effectiveness is not a measure of specific effects.

I am most grateful for this comment because it highlights an issue that I had wanted to address for some time: The meanings of the two terms ‘efficacy and effectiveness’ and their differences as seen by scientists and by alternative practitioners/researchers.

Let’s start with the definitions.

I often use the excellent book of Alan Earl-Slater entitled THE HANDBOOK OF CLINICAL TRIALS AND OTHER RESEARCH. In it, EFFICACY is defined as ‘the degree to which an intervention does what it is intended to do under ideal conditions. EFFECTIVENESS is the degree to which a treatment works under real life conditions. An EFFECTIVENESS TRIAL is a trial that ‘is said to approximate reality (i. e. clinical practice). It is sometimes called a pragmatic trial’. An EFFICACY TRIAL ‘is a clinical trial that is said to take place under ideal conditions.’

In other words, an efficacy trial investigates the question, ‘can the therapy work?’, and an effectiveness trial asks, ‘does this therapy work?’ In both cases, the question relate to the therapy per se and not to the plethora of phenomena which are not directly related to it. It seems logical that, where possible, the first question would need to be addressed before the second – it does make little sense to test for effectiveness, if efficacy has not been ascertained, and effectiveness without efficacy does not seem to be possible.

In my 2007 book entitled UNDERSTANDING RESEARCH IN COMPLEMENTARY AND ALTERNATIVE MEDICINE (written especially for alternative therapists like Mel), I adopted these definitions and added: “It is conceivable that a given therapy works only under optimal conditions but not in everyday practice. For instance, in clinical practice patients may not comply with a therapy because it causes adverse effects.” I should have added perhaps that adverse effects are by no means the only reason for non-compliance, and that non-compliance is not the only reason why an efficacious treatment might not be effective.

Most scientists would agree with the above definitions. In fact, I am not aware of a debate about them in scientific circles. But they are not something alternative practitioners tend to like. Why? Because, using these strict definitions, many alternative therapies are neither of proven efficacy nor effectiveness.

What can be done about this unfortunate situation?

Simple! Let’s re-formulate the definitions of efficacy and effectiveness!

Efficacy, according to some alternative medicine proponents, refers to the therapeutic effects of the therapy per se, in other words, its specific effects. (That coincides almost with the scientific definition of this term – except, of course, it fails to tell us anything about the boundary conditions [optimal or real-life conditions].)

Effectiveness, according to the advocates of alternative therapies, refers to its specific effects plus its non-specific effects. Some researchers have even introduced the term ‘real-life effectiveness’ for this.

This is why, the authors of the study discussed in my previous post, could conclude that “aromatherapy massage and reflexology are simple… effective… interventions… to help manage pain and fatigue in patients with rheumatoid arthritis.” Based on their data, neither aromatherapy nor reflexology has been shown to be effective. They might appear to be effective because patients expected to get better, or patients in the no-treatment control group felt worse for not getting the extra care. Based on studies of this nature, giving patients £10 or a box of chocolate might also turn out to be “simple… effective… interventions… to help manage pain and fatigue in patients with rheumatoid arthritis.” Based on these definitions of efficacy and effectiveness, there are hardly any limits to bogus claims for any old quackery.

Such obfuscation suits proponents of alternative therapies fine because, using such definitions, virtually every treatment anyone might ever think of can be shown to be effective! Wishful thinking, it seems, can fulfil almost any dream, it can even turn the truth upside down.

Or can anyone name an alternative treatment that cannot even generate a placebo response when administered with empathy, sympathy and care? Compared to doing nothing, virtually every ineffective therapy might generate outcomes that make the treatment look effective. Even the anticipation of an effect alone might do the trick. How often have you had a tooth-ache, went to the dentist, and discovered sitting in the waiting room that the pain had gone? Does that mean that sitting in a waiting room is an effective treatment for dental pain?

In fact, some enthusiasts of alternative medicine could soon begin to argue that, with their new definition of ‘effectiveness’, we no longer need controlled clinical trials at all, if we want to demonstrate how effective alternative therapies truly are. We can just do observational studies without a control group, note that lots of patients get better, and ‘Bob is your uncle’!!! This is much faster, saves money, time and effort, and has the undeniable advantage of never generating a negative result.

To most outsiders, all this might seem a bit like splitting hair. However, I fear that it is far from that. In fact, it turns out to be a fairly fundamental issue in almost any discussion about the value or otherwise of alternative medicine. And, I think, it is also a matter of principle that reaches far beyond alternative medicine: if we allow various interest groups, lobbyists, sects, cults etc. to use their own definitions of fundamentally important terms, any dialogue, understanding or progress becomes almost impossible.

Alternative medicine has no shortage of research that suggests it to be effective. Almost invariably, however, one finds – when looking a bit more carefully at such investigations – that the positive conclusions are not warranted by the data. Here is an excellent, recent example:

This new study, authored by two Turkish nurses, was an RCT where the patients were randomly assigned to either an aromatherapy massage (n = 17), reflexology (n = 17) or the control group (n = 17). Aromatherapy massage was applied to both knees of subjects in group 1 for 30 minutes. Reflexology was administered to both feet of subjects in group 2 for 40 minutes during weekly home visits. The subjects of group 3, the control group, received no intervention.

Fifty-one subjects with rheumatoid arthritis were recruited from a university hospital rheumatology clinic in Turkey between July 2014 and January 2015 for this trial. Data were collected by personal information form, DAS28 index, Visual Analog Scale and Fatigue Severity Scale. Pain and fatigue scores were measured at baseline and within an hour after each intervention for 6 weeks.

Pain and fatigue scores significantly decreased in the aromatherapy massage and reflexology groups compared with the control group (p < .05). The reflexology intervention started to decrease pain and fatigue scores earlier than aromatherapy massage (week 1 vs week 2 for pain, week 1 vs week 4 for fatigue) (p < .05).

The authors concluded that aromatherapy massage and reflexology are simple and effective non-pharmacologic nursing interventions that can be used to help manage pain and fatigue in patients with rheumatoid arthritis.

I am sure that most readers have spotted the snag: the two interventions generated better outcomes than no therapy. It is quite simply wrong to assume that this outcome is specifically related to the two treatments. Both of these treatments are fairly agreeable and generate expectations, involve touch, attention and care. In my view, it is these latter factors which together have caused the better outcomes. And this is, of course, entirely unrelated to any specific effects of the two therapies.

This might well be trivial, but if such sloppy conclusions pollute the literature to the extend that they currently do in the realm of alternative medicine, it becomes important.

WHAT IS THE WORST THAT COULD HAPPEN TO HOMEOPATHS?

This might seem like a strange question, but I think it is quite interesting… bear with me.

The worse, you might think, is that the we all agree that highly diluted homeopathic remedies are pure placebos. Apart from the fact that this already is a broad consensus shared by virtually everyone in healthcare (except the homeopaths, of course), I think this is not the worst that could happen to homeopaths. They simply ignore the consensus, continue much as before and carry on earning a living by fooling the public (and often themselves as well).

No, the worse is the opposite of the above. The worse is that we all accept the homeopaths’ view. The worse is to say: Very well, we agree for the moment that your remedies are highly effective. And therefore we need to regulate them just as any other medicine.

In our yesterday’s response to the German homeopaths’ statement affirming the effectiveness of homeopathy, we tried to express exactly that. Here is the passage I am referring to:

Wenn dies für Homöopathen also so eindeutig ist, dann können die zuständigen Institutionen in den Arzneimittel-Gesellschaften (BfArM, AMG) Homöopathika genau so bewerten wie normale Medikamente…  die Politik sollte die Homöopathen bei ihrem eigenen Wort nehmen und sie denselben Prüfverfahren unterwerfen wie alle anderen Behandlungsverfahren auch.

And this is my (somewhat liberal) translation:

If homeopathy’s effectiveness is so crystal clear, the regulators should assess homeopathic remedies just like normal drugs…  politicians and regulators should take homeopaths by their own word and should apply the same standards as for all other medicines.

In the past, homeopaths have always wanted the cake and eat it; they pleaded that their remedies are so special and therefore they need special regulations and extra considerations. Because of these, they were sheltered and escaped any legal or ethical obligations to demonstrate effectiveness. This introduced an unjustified and regressive double standard with was detrimental to good healthcare, medical ethics and scientific progress.

Now that homeopaths (the Germans are merely an example, other countries’ homeopaths are much the same) have agreed on what they think is solid scientific proof, it is right and necessary to remove the special protection which homeopathy used to enjoy. Let’s for the moment accept the homeopaths’ argument (‘homeopathy is effective just like other medicines) and then force them to deliver the proof of their opinion according to the standards all medicines must be judged by!

That would surely be the end of all this nonsense, and homeopaths would find themselves hoisted by their own petard.

1 2 3 30
Recent Comments

Note that comments can now be edited for up to five minutes after they are first submitted.


Click here for a comprehensive list of recent comments.

Categories