evidence
Homeopathy has a long history in Canada. In 1842, James Lilli was probably the first Canadian homeopath to begin practicing in Toronto. Joseph J. Lancaster, who had studied in New York, began practicing sometime in the 1840s in Ontario. The ‘Homeopathic Medical Society of Canada’ was established in 1854 in Hamilton, Ontario.
Since these early days much has changed. At present, all health care professions in Ontario are governed by the ‘Regulated Health Professions Act’ which allows all health-care professions the same right to practice. This law upholds the belief that the public has the right to choose what health care it wishes, and that the government should only intervene to regulate where a profession poses a significant risk of harm to the public. Only allopathic professions are currently regulated, and, in Ontario, doctors are censured if they practice homeopathy.
All schools of homeopathy in Canada offer ‘diplomate status’ and all offer three-year, part-time courses (one or two weekends per month plus perhaps one or two evenings per week). There are no legal doctorate or university degree programs for homeopathy in Canada. A doctorate in any field other than allopathic medicine cannot legally be used while practicing homeopathy.
I have been reliably informed that the regulation of homeopathy in Ontario is about to change. A transitional council of the ‘College of Homeopaths of Ontario’ had already been appointed in September 2009. The next step in the regulatory process is now imminent. On April 1 this year, Ontario will proclaim the ‘Homeopathy Act’. The bill will further empower the ‘College of Homeopaths of Ontario’. This regulatory body will hence forth have control over who gets to call themselves a homeopath. In addition, it will also have a complaint tracking system.
This moves comes only days after the ‘Australian National Health and Medical Research Council’ has published the most thorough and independent assessment of homeopathy in the history of this form of alternative therapy. It concluded that homeopathy should not be used to treat health conditions that are chronic, serious, or could become serious. People who choose homeopathy may put their health at risk if they reject or delay treatments for which there is good evidence for safety and effectiveness.
In view of the fact that homeopathy has been disproven as a treatment that fails to have a positive risk/benefit balance, the move of the regulators in Ontario seems pure madness to me. It sends the wrong signal to consumers and gives credibility to a form of quackery.
In a nutshell: EVEN THE BEST REGULATION OF NONSENSE WILL RESULT IN NONSENSE!
Here is another short passage from my new book A SCIENTIST IN WONDERLAND. It describes the event where I was first publicly exposed to the weird and wonderful world of alternative medicine in the UK. It is also the scene which, in my original draft, was the very beginning of the book.
I hope that the excerpt inspires some readers to read the entire book – it currently is BOOK OF THE WEEK in the TIMES HIGHER EDUCATION!!!
… [an] aggressive and curious public challenge occurred a few weeks later during a conference hosted by the Research Council for Complementary Medicine in London. This organization had been established a few years earlier with the aim of conducting and facilitating research in all areas of alternative medicine. My impression of this institution, and indeed of the various other groups operating in this area, was that they were far too uncritical, and often proved to be hopelessly biased in favour of alternative medicine. This, I thought, was an extraordinary phenomenon: should research councils and similar bodies not have a duty to be critical and be primarily concerned about the quality of the research rather than the overall tenor of the results? Should research not be critical by nature? In this regard, alternative medicine appeared to be starkly different from any other type of health care I had encountered previously.
On short notice, I had accepted an invitation to address this meeting packed with about 100 proponents of alternative medicine. I felt that their enthusiasm and passion were charming but, no matter whom I talked to, there seemed to be little or no understanding of the role of science in all this. A strange naïvety pervaded this audience: alternative practitioners and their supporters seemed a bit like children playing “doctor and patient”. The language, the rituals and the façade were all more or less in place, but somehow they seemed strangely detached from reality. It felt a bit as though I had landed on a different planet. The delegates passionately wanted to promote alternative medicine, while I, with equal passion and conviction, wanted to conduct good science. The two aims were profoundly different. Nevertheless, I managed to convince myself that they were not irreconcilable, and that we would manage to combine our passions and create something worthwhile, perhaps even groundbreaking.
Everyone was excited about the new chair in Exeter; high hopes and expectations filled the room. The British alternative medicine scene had long felt discriminated against because they had no academic representation to speak of. I certainly did sympathize with this particular aspect and felt assured that, essentially, I was amongst friends who realized that my expertise and their enthusiasm could add up to bring about progress for the benefit of many patients.
During my short speech, I summarized my own history as a physician and a scientist and outlined what I intended to do in my new post—nothing concrete yet, merely the general gist. I stressed that my plan was to apply science to this field in order to find out what works and what doesn’t; what is safe and what isn’t. Science, I pointed out, generates progress through asking critical questions and through testing hypotheses. Alternative medicine would either be shown by good science to be of value, or it would turn out to be little more than a passing fad. The endowment of the Laing chair represented an important mile-stone on the way towards the impartial evaluation of alternative medicine, and surely this would be in the best interest of all parties concerned.
To me, all this seemed an entirely reasonable approach, particularly as it merely reiterated what I had just published in an editorial for The Lancet entitled “Scrutinizing the Alternatives”.
My audience, however, was not impressed. When I had finished, there was a stunned, embarrassed silence. Finally someone shouted angrily from the back row: “How did they dare to appoint a doctor to this chair?” I was startled by this question and did not quite understand. What had prompted this reaction? What did this audience expect? Did they think my qualifications were not good enough? Why were they upset by the appointment of a doctor? Who else, in their view, might be better equipped to conduct medical research?
It wasn’t until weeks later that it dawned on me: they had been waiting for someone with a strong commitment to the promotion of alternative medicine. Such a commitment could only come from an alternative practitioner. A doctor personified the establishment, and “alternative” foremost symbolized “anti-establishment”. My little speech had upset them because it confirmed their worst fears of being annexed by “the establishment”. These enthusiasts had hoped for a believer from their own ranks and certainly not for a doctor-scientist to be appointed to the world’s first chair of complementary medicine. They had expected that Exeter University would lend its support to their commercial and ideological interests; they had little understanding of the concept that universities should not be in the business of promoting anything other than high standards.
Even today, after having given well over 600 lectures on the topic of alternative medicine, and after coming on the receiving end of ever more hostile attacks, aggressive questions and personal insults, this particular episode is still etched deeply into my memory. In a very real way, it set the scene for the two decades to come: the endless conflicts between my agenda of testing alternative medicine scientifically and the fervent aspirations of enthusiasts to promote alternative medicine uncritically. That our positions would prove mutually incompatible had been predictable from the very start. The writing had been on the wall—but it took me a while to be able to fully understand the message.
Guest post by Louise Lubetkin
(A SCIENTIST IN WONDERLAND: A MEMOIRE OF SEARCHING FOR TRUTH AND FINDING TROUBLE has now been published. An apt opportunity perhaps to post a letter and comment from the person who helped me GREATLY in finishing it.)
People write memoirs for a variety of reasons but perhaps one of the strongest impelling forces is the need to make sense of one’s own experiences. It is not surprising that you, who spent your entire professional career searching for explanations, identifying associations and parsing correlations, found yourself looking at your own life with the same analytical curiosity. Memoir is in many respects a natural choice in this regard.
That you chose to undertake a profoundly personal inventory at this juncture is also understandable in human terms. Retirement, whether anticipated and planned for, or (as in your case) thrust rudely upon you, reorders one’s sense of identity in ways that cannot fail to prompt reflection. It would have been surprising had you not felt an urge to look back and take stock, to trace the narrative arc of your life from its beginnings in post-war Germany all the way to the quiet house in rural Suffolk where you now sit, surrounded by the comfort of books and the accumulated paraphernalia of a life spent digging and delving in search of the building blocks of truth.
Given the contentious circumstances surrounding your departure from academic life, it is quite likely that you will be asked whether your decision to write a memoir was driven, at least in part, by a desire to settle scores. I think you can dismiss such a question unhesitatingly. You have no scores to settle: you came to England after a steady and unbroken ascent to the apex of your professional career, voluntarily leaving behind a position that most people would regard with envy and deference. You were never a supplicant at Exeter’s door; far from it. The fact that things went inexorably downhill over the course of your 20 years’ tenure there, and ended so deplorably, is not a reflection on you, your department, or the quality or quantity of work you turned out. Rather, it is a reflection on the very nature of the work you went there to do – and if there is any message in your memoir, it is this:
Alternative medicine is not, at its heart, a logical enterprise, and its adherents are not committed to – nor even interested in – a rational evaluation of their methods. Rather, alternative medicine is primarily an ideological position, a political credo, a reaction against mainstream medicine. To many of its adherents and impassioned advocates, its appeal lies not in any demonstrable therapeutic efficacy but in its perceived outsider status as the countercultural medicine, the medicine for Everyman, the David to the bullying medical-pharmaceutical Goliath. That your research work would elicit howls of protest was perhaps inevitable, given the threat it posed to the profitable and powerful alternative medicine industry. But it didn’t stop there: astonishingly, your work drew the ire of none less than the meddlesome heir apparent to the British throne. Prince Charles’ attempts to stymie your work call to mind the twelfth century martyr Thomas à Becket, of whom Henry II reputedly cried: “Oh, who will rid me of this turbulent priest?” (Henry’s sycophantic henchmen were quick to oblige, dispatching the hapless cleric on the steps of Canterbury cathedral.)
It’s clear that you were acutely aware, as a young man growing up in Germany, that science was not immune to the corrupting influence of political ideology, and that the German medical profession had entered – enthusiastically – into a Faustian compact with the Nazi regime. You have exhibited a courageous insistence on confronting and examining a national past that has at times felt like an intensely personal burden to you. It is ironic that in going to sleepy Exeter in an earnest, conscious attempt to shake off the constricting, intrigue-ridden atmosphere of academic Vienna, you ultimately found yourself once again mired in a struggle against the influence of ideology and the manipulation of science for political ends.
You went to Exeter strictly as a scientist, a skilled inquirer, a methodical investigator, expecting to be able to bring the rigors of logic and the scientific method to bear on an area of medical practice that had until then not been subjected to any kind of systematic evaluation. Instead, you were caught in a maelstrom of intrigue far worse than that which you had gratefully left behind in Vienna, buffeted and bruised by forces against which a lesser man would surely not have had the fortitude to push back so long and so hard.
Hard to believe but, in the last 35 years, I have written or edited a total of 49 books; about half of them on alternative medicine and the rest on various subjects related to clinical medicine and research. Each time a new one comes out, I am excited, of course, but this one is special:
- I have not written a book for several years.
- I have worked on it much longer than on any book before.
- Never before have I written a book with is so much about myself.
- None of my previous book covered material that is as ‘sensitive’ as this one.
I started on this book shortly after TRICK OR TREATMENT had been published. Its initial working title was ALTERNATIVE MEDICINE: THE INSIDE STORY. My aim was to focus on the extraordinary things which had happened during my time in Exeter, to shed some light on the often not so quaint life in academia, and to show how bizarre the world of alternative medicine truly is. But several people who know about these things and who had glanced at the first draft chapters strongly advised me to radically change this concept. They told me that such a book could only work as a personal memoire.
Yet I was most reluctant to write about myself; I wanted to write about science, research as well as the obstacles which some people manage to put in their way. So, after much discussion and contemplation, I compromised and added the initial chapters which told the reader about my background and my work prior to the Exeter appointment. This brought in subjects like my research on ‘Nazi-medicine’ (which, I believe, is more important than that on alternative medicine) that seemed almost entirely unrelated to alternative medicine, and the whole thing began to look a bit disjointed, in my view. However, my advisers felt this was a step in the right direction and argued that my compromise was not enough; they wanted more about me as a person, my motivations, my background etc. Eventually I (partly) gave in and provided a bit more of what they seemed to want.
But I am clearly not a novelist, most of what I have ever written is medical stuff; my style is too much that of a scientist – dry and boring. In other words, my book seemed to be going nowhere. Just when, after years of hard work, I was about to throw it all in the bin, help came from a totally unexpected corner.
Louise Lubetkin (even today, I have never met her in person) had contributed several posts as ‘guest editor’ to this blog, and I very much liked her way with words. When she offered to have a look at my book, I was thrilled. It is largely thanks to her that my ‘memoire’ ever saw the light of day. She helped enormously with making it readable and with joining up the seemingly separate episodes describes in my book.
Finding a fitting title was far from easy. Nothing seemed to encapsulate its contents, and ‘A SCIENTIST IN WONDERLAND’, the title I eventually chose, is a bit of a compromise; the subtitle does describe it much better, I think: A MEMOIR OF SEARCHING FOR TRUTH AND FINDING TROUBLE.
Now that the book is about to be published, I am anxious as never before on similar occasions. I do, of course, not think for a minute that it will be anything near to a best-seller, but I want people with an interest in alternative medicine, academia or science to read it (get it from a library to save money) and foremost I want them to understand why I wrote it. For me, this is neither about settling scores nor about self-promotion, it is about telling a story which is important in more than one way.
Guest post by Nick Ross
If you’re a fan of Edzard Ernst – and who with a rational mind would not be – then you will be a fan of HealthWatch.
Edzard is a distinguished supporter. Do join us. I can’t promise much in return except that you will be part of a small and noble organisation that campaigns for treatments that work – in other words for evidence based medicine. Oh, and you get a regular Newsletter, which is actually rather good.
HealthWatch was inspired 25 years ago by Professor Michael Baum, the breast cancer surgeon who was incandescent that so many women presented to his clinic late, doomed and with suppurating sores, because they had been persuaded to try ‘alternative treatment’ rather than the real thing.
But like Edzard (and indeed like Michael Baum), HealthWatch keeps an open mind. If there are reliable data to show that an apparently weirdo treatment works, hallelujah. If there is evidence that an orthodox one doesn’t then it deserves a raspberry. HealthWatch has worked to expose quacks and swindlers and to get the Advertising Standards Authority to do its job regulating against false claims and flimflam. It has fought the NHS to have women given fair and balanced advice about the perils of mass screening. It has campaigned with Sense About Science, English Pen and Index to protect whistleblowing scientists from vexatious libel laws, and it has joined the AllTrials battle for transparency in drug trials. It has an annual competition for medical and nursing students to encourage critical analysis of clinical research protocols, and it stages the annual HealthWatch Award and Lecture which has featured Edzard (in 2005) and a galaxy of other champions of scepticism and good evidence including Sir Iain Chalmers, Richard Smith, David Colquhoun, Tim Harford, John Diamond, Richard Doll, Peter Wilmshurst, Ray Tallis, Ben Goldacre, Fiona Godlee and, last year, Simon Singh. We are shortly to sponsor a national debate on Lord Saatchi’s controversial Medical innovation Bill.
But we need new blood. Do please check us out. Be careful, because since we first registered our name a host of brazen copycats have emerged, not least Her Majesty’s Government with ‘Healthwatch England’ which is part of the Care Quality Commission. We have had to put ‘uk’ at the end of our web address to retain our identity. So take the link to http://www.healthwatch-uk.org/, or better still take out a (very modestly priced) subscription.
As Edmund Burke might well have said, all it takes for quackery to flourish is that good men and women do nothing.
Moxibustion is an ancient variation of acupuncture using moxa made from dried mugwort (Artemisia argyi). It has long played an important role in the traditional heath care systems of China and other Asian countries. More recently, it has become popular also in the West. Practitioners use moxa sticks indirectly to warm acupuncture needles, or burn it close to the patient’s skin. Essentially, moxibustion is a treatment where acupuncture points are stimulated mainly or exclusively by the heat of burning moxa.
Because of moxibustion’s long history of usage and the fact that it is employed in many countries for a very wide range of conditions, some might argue that it has stood the ‘test of time’ and should be considered to be a well-established therapy. More critical thinkers would, however, point out that this is not an argument but a classical fallacy.
My team at Exeter regularly had research fellows from Korea and other Asian countries, and we managed to develop a truly productive cooperation. It enabled us to conduct systematic reviews including the Asian literature – and this is how we got involved in an unusual amount of research into moxibustion which, after all, is a fairly exotic alternative therapy. In 2010, we began a series of systematic reviews of moxibustion.
One of the first such articles included 9 RCTs testing the effectiveness of this treatment for stroke rehabilitation. Three RCTs reported favorable effects of moxibustion plus standard care on motor function versus standard care alone Three randomized clinical trials compared the effects of moxibustion on activities of daily living alone but failed to show favorable effects of moxibustion.
Also in 2010, our systematic review of RCTs of moxibustion as a treatment of ulcerative colitis (UC) concluded that current evidence is insufficient to show that moxibustion is an effective treatment of UC. Most of included trials had high risk of bias. More rigorous studies seem warranted.
Our (2010) systematic review od RCTs of moxibustion as a therapy in cancer care found that the evidence was limited to suggest moxibustion is an effective supportive cancer care in nausea and vomiting. However, all studies had a high risk of bias so effectively there was not enough evidence to draw any conclusion.
Our (2010) systematic review of RCTs of moxibustion for treating hypertension concluded that there was insufficient evidence to suggest that moxibustion is an effective treatment for hypertension.
Our (2010) systematic review of RCTs of moxibustion for constipation concluded as follows: Given that the methodological quality of all RCTs was poor, the results from the present review are insufficient to suggest that moxibustion is an effective treatment for constipation. More rigorous studies are warranted.
Our (2010) systematic review found few RCTs were available that test the effectiveness of moxibustion in the management of pain, and most of the existing trials had a high risk of bias. Therefore, more rigorous studies are required before the effectiveness of moxibustion for the treatment of pain can be determined.
Our (2011) systematic review of 14 RCTs of moxibustion for rheumatic conditions failed to provide conclusive evidence for the effectiveness of moxibustion compared with drug therapy in rheumatic conditions.
The, so far, last article in this series has only just been published. The purpose of this systematic review was to assess the efficacy of moxibustion as a treatment of chemotherapy-induced leukopenia. Twelve databases were searched from their inception through June 2014, without a language restriction. Randomized clinical trials (RCTs) were included, if moxibustion was used as the sole treatment or as a part of a combination therapy with conventional drugs for leukopenia induced by chemotherapy. Cochrane criteria were used to assess the risk of bias.
Six RCTs with a total of 681 patients met our inclusion criteria. All of the included RCTs were associated with a high risk of bias. The trials included patients with various types of cancer receiving ongoing chemotherapy or after chemotherapy. The results of two RCTs suggested the effectiveness of moxibustion combined with chemotherapy vs. chemotherapy alone. In four RCTs, moxibustion was more effective than conventional drug therapy. Six RCTs showed that moxibustion was more effective than various types of control interventions in increasing white blood cell counts.
Our conclusion: there is low level of evidence based on these six trials that demonstrates the superiority of moxibustion over drug therapies in the treatment of chemotherapy-induced leukopenia. However, the number of trials, the total sample size, and the methodological quality are too low to draw firm conclusions. Future RCTs appear to be warranted.
Was all this research for nothing?
I know many people who would think so. However, I disagree. If nothing else, these articles demonstrated several facts quite clearly:
- There is quite a bit of research even on the most exotic alternative therapy; sometimes one needs to look hard and include languages other than English.
- Studies from China and other Asian counties very rarely report negative results; this fact casts a dark shadow on the credibility of such data.
- The poor quality of trials in most areas of alternative medicine is lamentable and must be stimulus for researchers in this field to improve their act.
- Authors of systematic reviews must resist the temptation to draw positive conclusions based on flawed primary data.
- Moxibustion is a perfect example for demonstrating that the ‘test of time’ is no substitute for evidence.
- As for moxibustion, it cannot currently be considered an evidence-based treatment for any condition.
I know, it’s not really original to come up with the 10000th article on “10 things…” – but you will have to forgive me, I read so many of these articles over the holiday period that I can’t help but jump on the already over-crowded bandwagon and compose yet another one.
So, here are 10 things which could, if implemented, bring considerable improvement in 2015 to my field of inquiry, alternative medicine.
- Consumers need to get better at acting as bull shit (BS) detectors. Let’s face it, much of what we read or hear about this subject is utter BS. Yet consumers frequently lap up even the worst drivel like it were some source of deep wisdom. They could save themselves so much money, if they learnt to be just a little bit more critical.
- Dr Oz should focus on being a heart surgeon. His TV show has been demonstrated far too often to be promoting dangerous quackery. Yet as a heart surgeon, he actually might do some good.
- Journalists ought to remember that they have a job that extends well beyond their ambition to sell copy. They have a responsibility to inform the public truthfully and responsibly.
- Book publishers should abstain from churning out book after book that does little else but mislead the public about alternative medicine in a way that all to often is dangerous to the readers’ health. The world does not need the 1000th book repeating nonsense on detox, wellness etc.!
- Alternative practitioners must realise that claiming that therapy x cures condition y is not just slightly over-optimistic (or based on ‘years of experience’); if the claim is not based on sound evidence, it is what most people would call an outright lie.
- Proponents of alternative medicine should learn that it is neither fair nor productive to fiercely attack everyone personally who disagrees with their enthusiasm for this or that form of alternative medicine. In fact, it merely highlights the acute lack of rational arguments.
- Researchers of alternative medicine have to remember how important it is to think critically – an uncritical scientist is at best a contradiction in terms and at worst a pseudo-scientist who is likely to cause harm.
- Authorities should amass the courage, the political power and the financial means of going after those charlatans who ruthlessly exploit the public by making a fast and easy buck on the gullibility of consumers. Only if there is the likelihood of hefty fines will we see a meaningful decrease in the current epidemic of alternative health fraud.
- Politicians should realise that alternative medicine is not just a trivial subject with which one might win votes, if one issues platitudes to please the majority; alternative medicine is used by so many people that it has become an important public health issue.
- Prince Charles need to learn how to control himself and abstain from meddling in health politics by using every conceivable occasion to promote what he thinks is ‘integrated medicine’ but which, in fact, can easily be disclosed to be quackery.
As you see, my list almost instantly turned into a wish-list, and the big questions that follow from it are:
- How could we increase the likelihood of these wishes to come true?
- And would there be anything left of alternative medicine, if all of these wishes miraculously became true in 2015?
I do not pretend to have the answers, but I do feel strongly that a healthy dose of critical thinking in all levels of education – from kindergartens to schools, from colleges to universities etc. – would be a good and necessary starting point.
I know, my list is not just a wish list, it also is a wishful thinking list. It would be hopelessly naïve to assume that major advances will be made in 2015. I am realistic, sometimes even quite pessimistic, about progress in alternative medicine. But this does not mean that I or anyone else should just give up. 2015 will be a year where at least one thing is certain: you will see me continuing me my fight for reason, critical analysis, rational debate and good evidence – and that’s a promise!
Well, not everywhere actually; if you go on Medline, for instance, and search for ‘detox’, you hardly find anything at all on detox as used in alternative medicine. This is because there is no science behind it (for the purpose of this post, ‘detox’ means the alternative detox that is supposed to rid us from environmental poisons and, more relevant to the Christmas season, of the effects of over-indulgence). Notwithstanding this lack of science and evidence, detox is currently being heavily promoted in magazines, newspapers and, of course, via the Internet.
Take the heir to our thrown, Prince Charles, for instance; he famously marketed his Duchy Originals ‘DETOX TINCTURE’. And he has competition from thousands who also exploit the gullible with similar placebos. One website even claimed that “2014 was the year of the cleanse diet. Celebrities swear by them and more and more people have been getting in on the action, whether it’s to detox diet, brighten skin, lose weight, or get a fresh start. And nowhere is that more evident than in Yahoo’s Year in Review, where different health cleanses consistently topped the site’s most popular stories lists. Here, the year’s top 10 most popular cleanses.”
The author then continues by promoting 10 different forms of detox:
1. A Colon Cleanse.
2. A Liver Cleanse.
3. The Master Cleanse.
4. The 10-Day Green Smoothie Cleanse.
5. A Juice Cleanse.
6. Detox Cleanse.
7. Slendera Garcinia and Natural Cleanse.
8. Dherbs Full Body Cleanse.
9. Blueprint Cleanse.
10. Isagenix Cleanse for Life.
These treatments seem diverse but they all have one thing in common: they do not work; they do not eliminate poisons from the body, they merely eliminate cash from your wallet.
But being so very negative is not the way forward, some might argue. Why does he not tell us which forms of detox do actually work?
Because it is Christmas, I will do just that and provide my readers with a full list of detox treatments that are effective. If you are looking for a specific type of detox and it is not on the list, it means you should spend your money on something else, stop over-indulging yourself and adopt a sensibly health lifestyle.
HERE WE GO – THIS IS MY COMPLETE LIST OF EFFECTIVE FORMS OF DETOX:
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MERRY CHRISTMAS EVERYONE
As I have said on several occasions before: I am constantly on the lookout for new rigorous science that supports the claims of alternative medicine. Thus I was delighted to find a recent and potentially important article with some positive evidence.
Fish oil has been studied extensively in terms of its effects on health. We know that it has powerful anti-inflammatory properties and might thus benefit a wide range of conditions. However, the effects of FO in rheumatoid arthritis (RA) have not been examined in the context of contemporary treatment of early RA.
A new study has tried to fill this gap by examining the effects of high versus low dose FO in early RA employing a ‘treat-to-target’ protocol of combination disease-modifying anti-rheumatic drugs (DMARDs).
Patients with RA <12 months’ duration and who were DMARD-naïve were enrolled and randomised 2:1 to FO at a high dose or low dose (for masking). These groups, designated FO and control, were given 5.5 or 0.4 g/day, respectively, of the omega-3 fats, eicosapentaenoic acid + docosahexaenoic acid. All patients received methotrexate (MTX), sulphasalazine and hydroxychloroquine, and DMARD doses were adjusted according to an algorithm taking disease activity and toxicity into account. DAS28-erythrocyte sedimentation rate, modified Health Assessment Questionnaire (mHAQ) and remission were assessed three monthly. The primary outcome measure was failure of triple DMARD therapy.
In the FO group, failure of triple DMARD therapy was lower (HR=0.28 (95% CI 0.12 to 0.63; p=0.002) unadjusted and 0.24 (95% CI 0.10 to 0.54; p=0.0006) following adjustment for smoking history, shared epitope and baseline anti–cyclic citrullinated peptide. The rate of first American College of Rheumatology (ACR) remission was significantly greater in the FO compared with the control group (HRs=2.17 (95% CI 1.07 to 4.42; p=0.03) unadjusted and 2.09 (95% CI 1.02 to 4.30; p=0.04) adjusted). There were no differences between groups in MTX dose, DAS28 or mHAQ scores, or adverse events.
The authors concluded that FO was associated with benefits additional to those achieved by combination ‘treat-to-target’ DMARDs with similar MTX use. These included reduced triple DMARD failure and a higher rate of ACR remission.
So here we have a dietary supplement that actually might generate more good than harm! There is a mountain of data of good research on the subject. We understand the mechanism of action and we have encouraging clinical evidence. Some people might still say that we do not need to take supplements in order to benefit from the health effects of FO, consuming fatty fish regularly might have the same effects. This is true, of course, but the amount of fish that one would need to eat every day would probably be too large for most people’s taste.
The drawback (from the perspective of alternative medicine) in all this is, of course, that some experts might deny that FO has much to do with alternative medicine. Again: what do we call alternative medicine that works? We call it MEDICINE! And perhaps FO is an excellent example of exactly that.
Guest post by Pete Attkins
Commentator “jm” asked a profound and pertinent question: “What DOES it take for people to get real in this world, practice some common sense, and pay attention to what’s going on with themselves?” This question was asked in the context of asserting that personal experience always trumps the results of large-scale scientific experiments; and asserting that alt-med experts are better able to provide individulized healthcare than 21st Century orthodox medicine.
What does common sense and paying attention lead us to conclude about the following? We test a six-sided die for bias by rolling it 100 times. The number 1 occurs only once and the number 6 occurs many times, never on its own, but in several groups of consecutive sixes.
I think it is reasonable to say that common sense would, and should, lead everyone to conclude that the die is biased and not fit for its purpose as a source of random numbers.
In other words, we have a gut feeling that the die is untrustworthy. Gut instincts and common sense are geared towards maximizing our chances of survival in our complex and unpredictable world — these are innate and learnt behaviours that have enabled humans to survive despite the harshness of our ever changing habitat.
Only very recently in the long history of our species have we developed specialized tools that enable us to better understand our harsh and complex world: science and critical thinking. These tools are difficult to master because they still haven’t been incorporated into our primary and secondary formal education systems.
The vast majority of people do not have these skills therefore, when a scientific finding flies in the face of our gut instincts and/or common sense, it creates an overwhelming desire to reject the finding and classify the scientist(s) as being irrational and lacking basic common sense. It does not create an intense desire to accept the finding then painstakingly learn all of the science that went into producing the finding.
With that in mind, let’s rethink our common sense conclusion that the six-sided die is biased and untrustworthy. What we really mean is that the results have given all of us good reason to be highly suspicious of this die. We aren’t 100% certain that this die is biased, but our gut feeling and common sense are more than adequate to form a reasonable mistrust of it and to avoid using it for anything important to us. Reasons to keep this die rather than discard it might be to provide a source of mild entertainment or to use its bias for the purposes of cheating.
Some readers might be surprised to discover at this point that the results I presented from this apparently heavily-biased die are not only perfectly valid results obtained from a truly random unbiased die, they are to be fully expected. Even if the die had produced 100 sixes in that test, it would not confirm that the die is biased in any way whatsoever. Rolling a truly unbiased die once will produce one of six possible outcomes. Rolling the same die 100 times will produce one unique sequence out of the 6^100 (6.5 x 10^77) possible sequences: all of which are equally valid!
Gut feeling plus common sense rightfully informs us that the probability of a random die producing one hundred consecutive sixes is so incredibly remote that nobody will ever see it occur in reality. This conclusion is also mathematically sound: if there were 6.5 x 10^77 people on Earth, each performing the same test on truly random dice, there is no guarantee that anyone would observe a sequence of one hundred consecutive sixes.
When we observe a sequence such as 2 5 1 4 6 3 1 4 3 6 5 2… common sense informs us that the die is very likely random. If we calculate the arithmetic mean to be very close to 3.5 then common sense will lead us to conclude that the die is both random and unbiased enough to use it as a reliable source of random numbers.
Unfortunately, this is a perfect example of our gut feelings and common sense failing us abysmally. They totally failed to warn us that the 2 5 1 4 6 3 1 4 3 6 5 2… sequence we observed had exactly the same (im)probability of occurring as a sequence of one hundred 6s or any other sequence that one can think of that doesn’t look random to a human observer.
The 100-roll die test is nowhere near powerful enough to properly test a six-sided die, but this test is more than adequately powered to reveal some of our cognitive biases and some of the deficits in our personal mastery of science and critical thinking.
To properly test the die we need to provide solid evidence that it is both truly random and that its measured bias tends towards zero as the number of rolls tends towards infinity. We could use the services of one testing lab to conduct billions of test rolls, but this would not exclude errors caused by such things as miscalibrated equipment and experimenter bias. It is better to subdivide the testing across multiple labs then carefully analyse and appropriately aggregate the results: this dramatically reduces errors caused by equipment and humans.
In medicine, this testing process is performed via systematic reviews of multiple, independent, double-blind, placebo-controlled trials — every trial that is insufficiently powered to add meaningfully to the result is rightfully excluded from the aggregation.
Alt-med relies on a diametrically opposed testing process. It performs a plethora of only underpowered tests; presents those that just happen to show a positive result (just as a random die could’ve produced); and sweeps under the carpet the overwhelming number of tests that produced a negative result. It publishes only the ‘successes’, not its failures. By sweeping its failures under the carpet it feels justified in making the very bold claim: Our plethora of collected evidence shows clearly that it mostly ‘works’ and, when it doesn’t, it causes no harm.
One of the most acidic tests for a hypothesis and its supporting data (which is a mandatory test in a few branches of critical engineering) is to substitute the collected data for random data that has been carefully crafted to emulate the probability mass functions of the collected datasets. This test has to be run multiple times for reasons that I’ve attempted to explain in my random die example. If the proposer of the hypothesis is unable to explain the multiple failures resulting from this acid test then it is highly likely that the proposer either does not fully understand their hypothesis or that their hypothesis is indistinguishable from the null hypothesis.
