scientific misconduct
When we talk about conflicts of interest, we usually think of financial concerns. But conflicts of interests also extend to non-financial matters, such as strong beliefs. These are important in alternative medicine – I would even go as far as to claim that they dominate this field.
My detractors have often claimed that this is where my problem lies. They are convinced that, in 1993, I came into the job as PROFESSOR OF COMPLEMENTARY MEDICINE with an axe to grind; I was determined or perhaps even paid to show that all alternative medicine is utter hocus-pocus, they say. The truth is that, if anything, I was on the side of alternative medicine – and I can prove it. Using the example of homeopathy, I have dedicated an entire article to demonstrate that the myth is untrue – I was not closed-minded or out to ditch homeopathy (or any other form of alternative medicine for that matter).
What then could constitute my ‘conflict of interest’? Surely, he was bribed, I hear them say. Just look at the funds he took from industry. Some of those people have even gone to the trouble of running freedom of information requests to obtain the precise figures for my research-funding. Subsequently they triumphantly publish them and say: Look he got £x from this company and £y from that firm. And they are, of course, correct: I did receive support from commercially interested parties on several occasions. But what my detractors forget is that these were all pro-alternative medicine institutions. More importantly, I always made very sure that no strings were attached with any funds we accepted.
Our core funds came from ‘The Laing Foundation’ which endowed Exeter University with £ 1.5 million. This was done with the understanding that Exeter would put the same amount again into the kitty (which they never did). Anyone who can do simple arithmetic can tell that, to sustain up to 20 staff for almost 20 years, £1.5 million is not nearly enough. There must have been other sources. Who exactly gave money?
Despite utterly useless fundraising by the University, we did manage to obtain additional funds. I managed to receive support in the form of multiple research fellowships, for instance. It came from various sources; for instance, manufacturers of herbal medicines, Boots, the Pilkington Family Trust (yes, the glass manufacturers).
A hugely helpful contributor to our work was the sizable number (I estimate around 30) of visitors from abroad who came on their own money simply because they wanted to learn from and with us. They stayed between 3 months and 4 years, and importantly contributed to our research, knowledge and fun.
In addition, we soon devised ways to generate our own money. For instance, we started an annual conference for researchers in our field which ran for 14 successful years. As we managed everything on a shoestring and did all the organisation ourselves, we made a tidy profit each year which, of course, went straight back into our research. We also published several books which generated some revenue for the same purpose.
And then we received research funding for specific projects, for instance, from THE PRINCE OF WALES’ FOUNDATION FOR INTEGRATED HEALTH, a Japanese organisation supporting Jorhei Healing, THE WELCOME TRUST, the NHS, and even a homeopathic company.
So, do I have a conflict of interest? Did I take money from anyone who might have wanted to ditch alternative medicine? I don’t think so! And if I tell you that, when I came to Exeter in 1993, I donated ~£120 000 of my own funds towards the research of my unit, even my detractors might, for once, be embarrassed to have thought otherwise.
Do you think that chiropractic is effective for asthma? I don’t – in fact, I know it isn’t because, in 2009, I have published a systematic review of the available RCTs which showed quite clearly that the best evidence suggested chiropractic was ineffective for that condition.
But this is clearly not true, might some enthusiasts reply. What is more, they can even refer to a 2010 systematic review which indicates that chiropractic is effective; its conclusions speak a very clear language: …the eight retrieved studies indicated that chiropractic care showed improvements in subjective measures and, to a lesser degree objective measures… How on earth can this be?
I would not be surprised, if chiropractors claimed the discrepancy is due to the fact that Prof Ernst is biased. Others might point out that the more recent review includes more studies and thus ought to be more reliable. The newer review does, in fact, have about twice the number of studies than mine.
How come? Were plenty of new RCTs published during the 12 months that lay between the two publications? The answer is NO. But why then the discrepant conclusions?
The answer is much less puzzling than you might think. The ‘alchemists of alternative medicine’ regularly succeed in smuggling non-evidence into such reviews in order to beautify the overall picture and confirm their wishful thinking. The case of chiropractic for asthma does by no means stand alone, but it is a classic example of how we are being misled by charlatans.
Anyone who reads the full text of the two reviews mentioned above will find that they do, in fact, include exactly the same amount of RCTs. The reason why they arrive at different conclusions is simple: the enthusiasts’ review added NON-EVIDENCE to the existing RCTs. To be precise, the authors included one case series, one case study, one survey, two randomized controlled trials (RCTs), one randomized patient and observer blinded cross-over trial, one single blind cross study design, and one self-reported impairment questionnaire.
Now, there is nothing wrong with case reports, case series, or surveys – except THEY TELL US NOTHING ABOUT EFFECTIVENESS. I would bet my last shirt that the authors know all of that; yet they make fairly firm and positive conclusions about effectiveness. As the RCT-results collectively happen to be negative, they even pretend that case reports etc. outweigh the findings of RCTs.
And why do they do that? Because they are interested in the truth, or because they don’t mind using alchemy in order to mislead us? Your guess is as good as mine.
Systematic reviews are widely considered to be the most reliable type of evidence for judging the effectiveness of therapeutic interventions. Such reviews should be focused on a well-defined research question and identify, critically appraise and synthesize the totality of the high quality research evidence relevant to that question. Often it is possible to pool the data from individual studies and thus create a new numerical result of the existing evidence; in this case, we speak of a meta-analysis, a sub-category of systematic reviews.
One strength of systematic review is that they minimise selection and random biases by considering at the totality of the evidence of a pre-defined nature and quality. A crucial precondition, however, is that the quality of the primary studies is critically assessed. If this is done well, the researchers will usually be able to determine how robust any given result is, and whether high quality trials generate similar findings as those of lower quality. If there is a discrepancy between findings from rigorous and flimsy studies, it is obviously advisable to trust the former and discard the latter.
And this is where systematic reviews of alternative treatments can run into difficulties. For any given research question in this area we usually have a paucity of primary studies. Equally important is the fact that many of the available trials tend to be of low quality. Consequently, there often is a lack of high quality studies, and this makes it all the more important to include a robust critical evaluation of the primary data. Not doing so would render the overall result of the review less than reliable – in fact, such a paper would not qualify as a systematic review at all; it would be a pseudo-systematic review, i.e. a review which pretends to be systematic but, in fact, is not. Such papers are a menace in that they can seriously mislead us, particularly if we are not familiar with the essential requirements for a reliable review.
This is precisely where some promoters of bogus treatments seem to see their opportunity of making their unproven therapy look as though it was evidence-based. Pseudo-systematic reviews can be manipulated to yield a desired outcome. In my last post, I have shown that this can be done by including treatments which are effective so that an ineffective therapy appears effective (“chiropractic is so much more than just spinal manipulation”). An even simpler method is to exclude some of the studies that contradict one’s belief from the review. Obviously, the review would then not comprise the totality of the available evidence. But, unless the reader bothers to do a considerable amount of research, he/she would be highly unlikely to notice. All one needs to do is to smuggle the paper past the peer-review process – hardly a difficult task, given the plethora of alternative medicine journals that bend over backwards to publish any rubbish as long as it promotes alternative medicine.
Alternatively (or in addition) one can save oneself a lot of work and omit the process of critically evaluating the primary studies. This method is increasingly popular in alternative medicine. It is a fool-proof method of generating a false-positive overall result. As poor quality trials have a tendency to deliver false-positive results, it is obvious that a predominance of flimsy studies must create a false-positive result.
A particularly notorious example of a pseudo-systematic review that used this as well as most of the other tricks for misleading the reader is the famous ‘systematic’ review by Bronfort et al. It was commissioned by the UK GENERAL CHIROPRACTIC COUNCIL after the chiropractic profession got into trouble and was keen to defend those bogus treatments disclosed by Simon Singh. Bronfort and his colleagues thus swiftly published (of course, in a chiro-journal) an all-encompassing review attempting to show that, at least for some conditions, chiropractic was effective. Its lengthy conclusions seemed encouraging: Spinal manipulation/mobilization is effective in adults for: acute, subacute, and chronic low back pain; migraine and cervicogenic headache; cervicogenic dizziness; manipulation/mobilization is effective for several extremity joint conditions; and thoracic manipulation/mobilization is effective for acute/subacute neck pain. The evidence is inconclusive for cervical manipulation/mobilization alone for neck pain of any duration, and for manipulation/mobilization for mid back pain, sciatica, tension-type headache, coccydynia, temporomandibular joint disorders, fibromyalgia, premenstrual syndrome, and pneumonia in older adults. Spinal manipulation is not effective for asthma and dysmenorrhea when compared to sham manipulation, or for Stage 1 hypertension when added to an antihypertensive diet. In children, the evidence is inconclusive regarding the effectiveness for otitis media and enuresis, and it is not effective for infantile colic and asthma when compared to sham manipulation. Massage is effective in adults for chronic low back pain and chronic neck pain. The evidence is inconclusive for knee osteoarthritis, fibromyalgia, myofascial pain syndrome, migraine headache, and premenstrual syndrome. In children, the evidence is inconclusive for asthma and infantile colic.
Chiropractors across the world cite this paper as evidence that chiropractic has at least some evidence base. What they omit to tell us (perhaps because they do not appreciate it themselves) is the fact that Bronfort et al
- failed to formulate a focussed research question,
- invented his own categories of inconclusive findings,
- included all sorts of studies which had nothing to do with chiropractic,
- and did not to make an assessment of the quality of the included primary studies they included in their review.
If, for a certain condition, three trials were included, for instance, two of which were positive but of poor quality and one was negative but of good quality, the authors would conclude that, overall, there is sound evidence.
Bronfort himself is, of course, more than likely to know all that (he has learnt his trade with an excellent Dutch research team and published several high quality reviews) – but his readers mostly don’t. And for chiropractors, this ‘systematic’ review is now considered to be the most reliable evidence in their field.
The efficacy or effectiveness of medical interventions is, of course, best tested in clinical trials. The principle of a clinical trial is fairly simple: typically, a group of patients is divided (preferably at random) into two subgroups, one (the ‘verum’ group) is treated with the experimental treatment and the other (the ‘control’ group) with another option (often a placebo), and the eventual outcomes of the two groups is compared. If done well, such studies are able to exclude biases and confounding factors such that their findings allow causal inference. In other words, they can tell us whether an outcome was caused by the intervention per se or by some other factor such as the natural history of the disease, regression towards the mean etc.
A clinical trial is a research tool for testing hypotheses; strictly speaking, it tests the ‘null-hypothesis’: “the experimental treatment generates the same outcomes as the treatment of the control group”. If the trial shows no difference between the outcomes of the two groups, the null-hypothesis is confirmed. In this case, we commonly speak of a negative result. If the experimental treatment was better than the control treatment, the null-hypothesis is rejected, and we commonly speak of a positive result. In other words, clinical trials can only generate positive or negative results, because the null-hypothesis must either be confirmed or rejected – there are no grey tones between the black of a negative and the white of a positive study.
For enthusiasts of alternative medicine, this can create a dilemma, particularly if there are lots of published studies with negative results. In this case, the totality of the available trial evidence is negative which means the treatment in question cannot be characterised as effective. It goes without saying that such an overall conclusion rubs the proponents of that therapy the wrong way. Consequently, they might look for ways to avoid this scenario.
One fairly obvious way of achieving this aim is to simply re-categorise the results. What, if we invented a new category? What, if we called some of the negative studies by a different name? What about NON-CONCLUSIVE?
That would be brilliant, wouldn’t it. We might end up with a simple statistic where the majority of the evidence is, after all, positive. And this, of course, would give the impression that the ineffective treatment in question is effective!
How exactly do we do this? We continue to call positive studies POSITIVE; we then call studies where the experimental treatment generated worst results than the control treatment (usually a placebo) NEGATIVE; and finally we call those studies where the experimental treatment created outcomes which were not different from placebo NON-CONCLUSIVE.
In the realm of alternative medicine, this ‘non-conclusive result’ method has recently become incredibly popular . Take homeopathy, for instance. The Faculty of Homeopathy proudly claim the following about clinical trials of homeopathy: Up to the end of 2011, there have been 164 peer-reviewed papers reporting randomised controlled trials (RCTs) in homeopathy. This represents research in 89 different medical conditions. Of those 164 RCT papers, 71 (43%) were positive, 9 (6%) negative and 80 (49%) non-conclusive.
This misleading nonsense was, of course, warmly received by homeopaths. The British Homeopathic Association, like many other organisations and individuals with an axe to grind lapped up the message and promptly repeated it: The body of evidence that exists shows that much more investigation is required – 43% of all the randomised controlled trials carried out have been positive, 6% negative and 49% inconclusive.
Let’s be clear what has happened here: the true percentage figures seem to show that 43% of studies (mostly of poor quality) suggest a positive result for homeopathy, while 57% of them (on average the ones of better quality) were negative. In other words, the majority of this evidence is negative. If we conducted a proper systematic review of this body of evidence, we would, of course, have to account for the quality of each study, and in this case we would have to conclude that homeopathy is not supported by sound evidence of effectiveness.
The little trick of applying the ‘NON-CONCLUSIVE’ method has thus turned this overall result upside down: black has become white! No wonder that it is so popular with proponents of all sorts of bogus treatments.
Whenever a new trial of an alternative intervention emerges which fails to confirm the wishful thinking of the proponents of that therapy, the world of alternative medicine is in turmoil. What can be done about yet another piece of unfavourable evidence? The easiest solution would be to ignore it, of course – and this is precisely what is often tried. But this tactic usually proves to be unsatisfactory; it does not neutralise the new evidence, and each time someone brings it up, one has to stick one’s head back into the sand. Rather than denying its existence, it would be preferable to have a tool which invalidates the study in question once and for all.
The ‘fatal flaw’ solution is simpler than anticipated! Alternative treatments are ‘very special’, and this notion must be emphasised, blown up beyond all proportions and used cleverly to discredit studies with unfavourable outcomes: the trick is simply to claim that studies with unfavourable results have a ‘fatal flaw’ in the way the alternative treatment was applied. As only the experts in the ‘very special’ treatment in question are able to judge the adequacy of their therapy, nobody is allowed to doubt their verdict.
Take acupuncture, for instance; it is an ancient ‘art’ which only the very best will ever master – at least that is what we are being told. So, all the proponents need to do in order to invalidate a trial, is read the methods section of the paper in full detail and state ‘ex cathedra’ that the way acupuncture was done in this particular study is completely ridiculous. The wrong points were stimulated, or the right points were stimulated but not long enough [or too long], or the needling was too deep [or too shallow], or the type of stimulus employed was not as recommended by TCM experts, or the contra-indications were not observed etc. etc.
As nobody can tell a correct acupuncture from an incorrect one, this ‘fatal flaw’ method is fairly fool-proof. It is also ever so simple: acupuncture-fans do not necessarily study hard to find the ‘fatal flaw’, they only have to look at the result of a study – if it was favourable, the treatment was obviously done perfectly by highly experienced experts; if it was unfavourable, the therapists clearly must have been morons who picked up their acupuncture skills in a single weekend course. The reasons for this judgement can always be found or, if all else fails, invented.
And the end-result of the ‘fatal flaw’ method is most satisfactory; what is more, it can be applied to all alternative therapies – homeopathy, herbal medicine, reflexology, Reiki healing, colonic irrigation…the method works for all of them! What is even more, the ‘fatal flaw’ method is adaptable to other aspects of scientific investigations such that it fits every conceivable circumstance.
An article documenting the ‘fatal flaw’ has to be published, of course – but this is no problem! There are dozens of dodgy alternative medicine journals which are only too keen to print even the most far-fetched nonsense as long as it promotes alternative medicine in some way. Once this paper is published, the proponents of the therapy in question have a comfortable default position to rely on each time someone cites the unfavourable study: “WHAT NOT THAT STUDY AGAIN! THE TREATMENT HAS BEEN SHOWN TO BE ALL WRONG. NOBODY CAN EXPECT GOOD RESULTS FROM A THERAPY THAT WAS NOT CORRECTLY ADMINISTERED. IF YOU DON’T HAVE BETTER STUDIES TO SUPPORT YOUR ARGUMENTS, YOU BETTER SHUT UP.”
There might, in fact, be better studies – but chances are that the ‘other side’ has already documented a ‘fatal flaw’ in them too.
It is usually BIG PHARMA who stands accused of being less than honest with the evidence, particularly when it runs against commercial interests; and the allegations prove to be correct with depressing regularity. In alternative medicine, commercial interests exist too, but there is usually much less money at stake. So, a common assumption is that conflicts of interest are less relevant in alternative medicine. Like so many assumptions in this area, this notion is clearly and demonstrably erroneous.
The sums of money are definitely smaller, but non-commercial conflicts of interest are potentially more important than the commercial ones. I am thinking of the quasi-religious beliefs that are so very prevalent in alternative medicine. Belief can move mountains, they say – it can surely delude people and make them do the most extraordinary things. Belief can transform advocates of alternative medicine into ‘ALCHEMISTS OF ALTERNATIVE EVIDENCE’ who turn negative/unfavourable into positive/favourable evidence.
The alchemists’ ‘tricks of the trade’ are often the same as used by BIG PHARMA; they include:
- drawing conclusions which are not supported by the data
- designing studies such that they will inevitably generate a favourable result
- cherry-picking the evidence
- hiding unfavourable findings
- publishing favourable results multiple times
- submitting data-sets to multiple statistical tests until a positive result emerges
- defaming scientists who publish unfavourable findings
- bribing experts
- prettify data
- falsifying data
As I said, these methods, albeit despicable, are well-known to pseudoscientists in all fields of inquiry. To assume that they are unknown in alternative medicine is naïve and unrealistic, as many of my previous posts confirm.
In addition to these ubiquitous ‘standard’ methods of scientific misconduct and fraud, there are a few techniques which are more or less unique to and typical for the alchemists of alternative medicine. In the following parts of this series of articles, I will try to explain these methods in more detail.
Cancer patients are bombarded with information about supplements which allegedly are effective for their condition. I estimate that 99.99% of this information is unreliable and much of it is outright dangerous. So, there is an urgent need for trustworthy, objective information. But which source can we trust?
The authors of a recent article in ‘INTEGRATIVE CANCER THARAPIES’ (the first journal to spearhead and focus on a new and growing movement in cancer treatment. The journal emphasizes scientific understanding of alternative medicine and traditional medicine therapies, and their responsible integration with conventional health care. Integrative care includes therapeutic interventions in diet, lifestyle, exercise, stress care, and nutritional supplements, as well as experimental vaccines, chrono-chemotherapy, and other advanced treatments) review the issue of dietary supplements in the treatment of cancer patients. They claim that the optimal approach is to discuss both the facts and the uncertainty with the patient, in order to reach a mutually informed decision. This sounds promising, and we might thus trust them to deliver something reliable.
In order to enable doctors and other health care professionals to have such discussion, the authors then report on the work of the ‘Clinical Practice Committee’ of ‘The Society of Integrative Oncology’. This panel undertook the challenge of providing basic information to physicians who wish to discuss these issues with their patients. A list of supplements that have the best suggestions of benefit was constructed by “leading researchers and clinicians“ who have experience in using these supplements:
- curcumin,
- glutamine,
- vitamin D,
- maitake mushrooms,
- fish oil,
- green tea,
- milk thistle,
- astragalus,
- melatonin,
- probiotics.
The authors claim that their review includes basic information on each supplement, such as evidence on effectiveness and clinical trials, adverse effects, and interactions with medications. The information was constructed to provide an up-to-date base of knowledge, so that physicians and other health care providers would be aware of the supplements and be able to discuss realistic expectations and potential benefits and risks (my emphasis).
At first glance, this task looks ambitious but laudable; however, after studying the paper in some detail, I must admit that I have considerable problems taking it seriously – and here is why.
The first question I ask myself when reading the abstract is: Who are these “leading researchers and clinicians”? Surely such a consensus exercise crucially depends on who is being consulted. The article itself does not reveal who these experts are, merely that they are all members of the ‘Society of Integrative Oncology’. A little research reveals this organisation to be devoted to integrating all sorts of alternative therapies into cancer care. If we assume that the experts are identical with the authors of the review; one should point out that most of them are proponents of alternative medicine. This lack of critical input seems more than a little disconcerting.
My next questions are: How did they identify the 10 supplements and how did they evaluate the evidence for or against them? The article informs us that a 5-step procedure was employed:
1. Each clinician in this project was requested to construct a list of supplements that they tend to use frequently in their practice.
2. An initial list of close to 25 supplements was constructed. This list included supplements that have suggestions of some possible benefit and likely to carry minimal risk in cancer care.
3. From that long list, the group agreed on the 10 leading supplements that have the best suggestions of benefit.
4. Each participant selected 1 to 2 supplements that they have interest and experience in their use and wrote a manuscript related to the selected supplement in a uniformed and agreed format. The agreed format was constructed to provide a base of knowledge, so physicians and other health care providers would be able to discuss realistic expectations and potential benefits and risks with patients and families that seek that kind of information.
5. The revised document was circulated among participants for revisions and comments.
This method might look fine to proponents of alternative medicine, but from a scientific point of view, it is seriously wanting. Essentially, they asked those experts who are in favour of a given supplement to write a report to justify his/her preference. This method is not just open bias, it formally invites bias.
Predictably then, the reviews of the 10 chosen supplements are woefully inadequate. These is no evidence of a systematic approach; the cited evidence is demonstrably cherry-picked; there is a complete lack of critical analysis; for several supplements, clinical data are virtually absent without the authors finding this embarrassing void a reason for concern; dosage recommendations are often vague and naïve, to say the least (for instance, for milk thistle: 200 to 400 mg per day – without indication of what the named weight range refers to, the fresh plant, dried powder, extract…?); safety data are incomplete and nobody seems to mind that supplements are not subject to systematic post-marketing surveillance; the text is full of naïve thinking and contradictions (e.g.”There are no reported side effects of the mushroom extracts or the Maitake D-fraction. As Maitake may lower blood sugar, it should be used with caution in patients with diabetes“); evidence suggesting that a given supplement might reduce the risk of cancer is presented as though this means it is an effective treatment for an existing cancer; cancer is usually treated as though it is one disease entity without any differentiation of different cancer types.
The authors declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article. But I do wonder, isn’t being in favour of integrating half-baked nonsense into cancer care and being selected for one’s favourable attitude towards certain supplements already a conflict of interest?
In any case, the review is in my view not of sufficient rigor to form the basis for well-informed discussions with patients. The authors of the review cite a guideline by the ‘Society of Integrative Oncology’ for the use of supplements in cancer care which states: For cancer patients who wish to use nutritional supplements, including botanicals for purported antitumor effects, it is recommended that they consult a trained professional. During the consultation, the professional should provide support, discuss realistic expectations, and explore potential benefits and risks. It is recommended that use of those agents occur only in the context of clinical trials, recognized nutritional guidelines, clinical evaluation of the risk/benefit ratio based on available evidence, and close monitoring of adverse effects. It seems to me that, with this review, the authors have not adhered to their own guideline.
Criticising the work of others is perhaps not very difficult, however, doing a better job usually is. So, can I offer anything that is better than the above criticised review? The answer is YES. Our initiative ‘CAM cancer’ provides up-to-date, concise and evidence-based systematic reviews of many supplements and other alternative treatments that cancer patients are likely to hear about. Their conclusions are not nearly as uncritically positive as those of the article in ‘INTEGRATIVE CANCER THERAPIES’.
I happen to believe that it is important for cancer patients to have access to reliable information and that it is unethical to mislead them with biased accounts about the value of any treatment.
Advocates of alternative medicine are incredibly fond of supporting their claims with anecdotes, or ‘case-reports’ as they are officially called. There is no question, case-reports can be informative and important, but we need to be aware of their limitations.
A recent case-report from the US might illustrated this nicely. It described a 65-year-old male patient who had had MS for 20 years when he decided to get treated with Chinese scalp acupuncture. The motor area, sensory area, foot motor and sensory area, balance area, hearing and dizziness area, and tremor area were stimulated once a week for 10 weeks, then once a month for 6 further sessions.
After the 16 treatments, the patient showed remarkable improvements. He was able to stand and walk without any problems. The numbness and tingling in his limbs did not bother him anymore. He had more energy and had not experienced incontinence of urine or dizziness after the first treatment. He was able to return to work full time. Now the patient has been in remission for 26 months.
The authors of this case-report conclude that Chinese scalp acupuncture can be a very effective treatment for patients with MS. Chinese scalp acupuncture holds the potential to expand treatment options for MS in both conventional and complementary or integrative therapies. It can not only relieve symptoms, increase the patient’s quality of life, and slow and reverse the progression of physical disability but also reduce the number of relapses and help patients.
There is absolutely nothing wrong with case-reports; on the contrary, they can provide extremely valuable pointers for further research. If they relate to adverse effects, they can give us crucial information about the risks associated with treatments. Nobody would ever argue that case-reports are useless, and that is why most medical journals regularly publish such papers. But they are valuable only, if one is aware of their limitations. Medicine finally started to make swift progress, ~150 years ago, when we gave up attributing undue importance to anecdotes, began to doubt established wisdom and started testing it scientifically.
Conclusions such as the ones drawn above are not just odd, they are misleading to the point of being dangerous. A reasonable conclusion might have been that this case of a MS-patient is interesting and should be followed-up through further observations. If these then seem to confirm the positive outcome, one might consider conducting a clinical trial. If this study proves to yield encouraging findings, one might eventually draw the conclusions which the present authors drew from their single case.
To jump at conclusions in the way the authors did, is neither justified nor responsible. It is unjustified because case-reports never lend themselves to such generalisations. And it is irresponsible because desperate patients, who often fail to understand the limitations of case-reports and tend to believe things that have been published in medical journals, might act on these words. This, in turn, would raise false hopes or might even lead to patients forfeiting those treatments that are evidence-based.
It is high time, I think, that proponents of alternative medicine give up their love-affair with anecdotes and join the rest of the health care professions in the 21st century.
One of the perks of researching alternative medicine and writing a blog about it is that one rarely runs out of good laughs. In perfect accordance with ERNST’S LAW, I have recently been entertained, amused, even thrilled by a flurry of ad hominem attacks most of which are true knee-slappers. I would like to take this occasion to thank my assailants for their fantasy and tenacity. Most days, these ad hominem attacks really do make my day.
I can only hope they will continue to make my days a little more joyous. My fear, however, is that they might, one day, run out of material. Even today, their claims are somewhat repetitive:
- I am not qualified
- I only speak tosh
- I do not understand science
- I never did any ‘real’ research
- Exeter Uni fired me
- I have been caught red-handed (not quite sure at what)
- I am on BIG PHARMA’s payroll
- I faked my research papers
Come on, you feeble-minded fantasists must be able to do better! Isn’t it time to bring something new?
Yes, I know, innovation is not an easy task. The best ad hominem attacks are, of course, always based on a kernel of truth. In that respect, the ones that have been repeated ad nauseam are sadly wanting. Therefore I have decided to provide all would-be attackers with some true and relevant facts from my life. These should enable them to invent further myths and use them as ammunition against me.
Sounds like fun? Here we go:
Both my grandfather and my father were both doctors
This part of my family history could be spun in all sorts of intriguing ways. For instance, one could make up a nice story about how I, even as a child, was brain-washed to defend the medical profession at all cost from the onslaught of non-medical healers.
Our family physician was a prominent homeopath
Ahhhh, did he perhaps mistreat me and start me off on my crusade against homeopathy? Surely, there must be a nice ad hominem attack in here!
I studied psychology at Munich but did not finish it
Did I give up psychology because I discovered a manic obsession or other character flaw deeply hidden in my soul?
I then studied medicine (also in Munich) and made a MD thesis in the area of blood clotting
No doubt this is pure invention. Where are the proofs of my qualifications? Are the data in my thesis real or invented?
My 1st job as a junior doctor was in a homeopathic hospital in Munich
Yes, but why did I leave? Surely they found out about me and fired me.
I had hands on training in several forms of alternative medicine, including homeopathy
Easy to say, but where are the proofs?
I moved to London where I worked in St George’s Hospital conducting research in blood rheology
Another invention? Where are the published papers to document this?
I went back to Munich university where I continued this line of research and was awarded a PhD
Another thesis? Again with dodgy data? Where can one see this document?
I became Professor Rehabilitation Medicine first at Hannover Medical School and later in Vienna
How did that happen? Did I perhaps bribe the appointment panels?
In 1993, I was appointed to the Chair in Complementary Medicine at Exeter university
Yes, we all know that; but why did I not direct my efforts towards promoting alternative medicine?
In Exeter, together with a team of ~20 colleagues, we published > 1000 papers on alternative medicine, more than anyone else in that field
Impossible! This number clearly shows that many of these articles are fakes or plagiaries.
My H-Index is currently >80
Same as above.
In 2012, I became Emeritus Professor of the University of Exeter
Isn’t ’emeritus’ the Latin word for ‘dishonourable discharge’?
I HOPE I CAN RELY ON ALL OF MY AD HOMINEM ATTACKERS TO USE THIS INFORMATION AND RENDER THE ASSAULTS MORE DIVERSE, REAL AND INTERESTING.
Irritable bowel syndrome (IBS) is common and often difficult to treat – unless, of course, you consult a homeopath. Here is just one of virtually thousands of quotes from homeopaths available on the Internet: Homeopathic medicine can reduce Irritable Bowel Syndrome (IBS) symptoms by lowering food sensitivities and allergies. Homeopathy treats the patient as a whole and does not simply focus on the disease. Careful attention is given to the minute details about the presenting complaints, including the severity of diarrhea, constipation, pain, cramps, mucus in the stools, nausea, heartburn, emotional triggers and conventional laboratory findings. In addition, the patient’s eating habits, food preferences, thermal attributes and sleep patterns are noted. The patient’s family history and diseases, along with the patient’s emotions are discussed. Then the homeopathic practitioner will select the remedy that most closely matches the symptoms.
Such optimism might be refreshing, but is there any reason for it? Is homeopathy really an effective treatment for IBS? To answer this question, we now have a brand-new Cochrane review. The aim of this review was to assess the effectiveness and safety of homeopathic treatment for treating irritable bowel syndrome (IBS). (This type of statement always makes me a little suspicious; how on earth can anyone truly assess the safety of a treatment by looking at a few studies? This is NOT how one evaluates safety!) The authors conducted extensive literature searches to identify all RCTs, cohort and case-control studies that compared homeopathic treatment with placebo, other control treatments, or usual care in adults with IBS. The primary outcome was global improvement in IBS.
Three RCTs with a total of 213 participants were included. No cohort or case-control studies were identified. Two studies compared homeopathic remedies to placebos for constipation-predominant IBS. One study compared individualised homeopathic treatment to usual care defined as high doses of dicyclomine hydrochloride, faecal bulking agents and a high fibre diet. Due to the low quality of reporting, the risk of bias in all three studies was unclear on most criteria and high for some criteria.
A meta-analysis of two studies with a total of 129 participants with constipation-predominant IBS found a statistically significant difference in global improvement between the homeopathic ‘asafoetida’ and placebo at a short-term follow-up of two weeks. Seventy-three per cent of patients in the homeopathy group improved compared to 45% of placebo patients. There was no statistically significant difference in global improvement between the homeopathic asafoetida plus nux vomica compared to placebo. Sixty-eight per cent of patients in the homeopathy group improved compared to 52% of placebo patients.
The overall quality of the evidence was very low. There was no statistically significant difference between individualised homeopathic treatment and usual care for the outcome “feeling unwell”. None of the studies reported on adverse events (which, by the way, should be seen as a breech in research ethics on the part of the authors of the three primary studies).
The authors concluded that a pooled analysis of two small studies suggests a possible benefit for clinical homeopathy, using the remedy asafoetida, over placebo for people with constipation-predominant IBS. These results should be interpreted with caution due to the low quality of reporting in these trials, high or unknown risk of bias, short-term follow-up, and sparse data. One small study found no statistically difference between individualised homeopathy and usual care (defined as high doses of dicyclomine hydrochloride, faecal bulking agents and diet sheets advising a high fibre diet). No conclusions can be drawn from this study due to the low number of participants and the high risk of bias in this trial. In addition, it is likely that usual care has changed since this trial was conducted. Further high quality, adequately powered RCTs are required to assess the efficacy and safety of clinical and individualised homeopathy compared to placebo or usual care.
THIS REVIEW REQUIRES A FEW FURTHER COMMENTS, I THINK
Asafoetida, the remedy used in two of the studies, is a plant native to Pakistan, Iran and Afghanistan. It is used in Ayurvedic herbal medicine to treat colic, intestinal parasites and irritable bowel syndrome. In the ‘homeopathic’ trials, asafoetida was used in relatively low dilutions, one that still contains molecules. It is therefore debatable whether this was really homeopathy or whether it is more akin to herbal medicine – it was certainly not homeopathy with its typical ultra-high dilutions.
Regardless of this detail, the Cochrane review does hardly provide sound evidence for homeopathy’s efficacy. On the contrary, my reading of its findings is that the ‘possible benefit’ is NOT real but a false positive result caused by the serious limitations of the original studies. The authors stress that the apparently positive result ‘should be interpreted with caution’; that is certainly correct.
So, if you are a proponent of homeopathy, as the authors of the review seem to be, you will claim that homeopathy offers ‘possible benefits’ for IBS-sufferers. But if you are not convinced of the merits of homeopathy, you might suggest that the evidence is insufficient to recommend homeopathy. I imagine that IBS-sufferers might get as frustrated with such confusion as most scientists will be. Yet there is hope; the answer could be imminent: apparently, a new trial is to report its results within this year.
IS THIS NEW TRIAL GOING TO CONTRIBUTE MEANINGFULLY TO OUR KNOWLEDGE?
It is a three-armed study (same 1st author as in the Cochrane review) which, according to its authors, seeks to explore the effectiveness of individualised homeopathic treatment plus usual care compared to both an attention control plus usual care and usual care alone, for patients with IBS. (Why “explore” and not “determine”, I ask myself.) Patients are randomly selected to be offered, 5 sessions of homeopathic treatment plus usual care, 5 sessions of supportive listening plus usual care or usual care alone. (“To be offered” looks odd to me; does that mean patients are not blinded to the interventions? Yes, indeed it does.) The primary clinical outcome is the IBS Symptom Severity at 26 weeks. Analysis will be by intention to treat and will compare homeopathic treatment with usual care at 26 weeks as the primary analysis, and homeopathic treatment with supportive listening as an additional analysis.
Hold on…the primary analysis “will compare homeopathic treatment with usual care“. Are they pulling my leg? They just told me that patients will be “offered, 5 sessions of homeopathic treatment plus usual care… or usual care alone“.
Oh, I see! We are again dealing with an A+B versus B design, on top of it without patient- or therapist-blinding. This type of analysis cannot ever produce a negative result, even if the experimental treatment is a pure placebo: placebo + usual care is always more than usual care alone. IBS-patients will certainly experience benefit from having the homeopaths’ time, empathy and compassion – never mind the remedies they get from them. And for the secondary analyses, things do not seem to be much more rigorous either.
Do we really need more trials of this nature? The Cochrane review shows that we currently have three studies which are too flimsy to be interpretable. What difference will a further flimsy trial make in this situation? When will we stop wasting time and money on such useless ‘research’? All it can possibly achieve is that apologists of homeopathy will misinterpret the results and suggest that they demonstrate efficacy.
Obviously, I have not seen the data (they have not yet been published) but I think I can nevertheless predict the conclusions of the primary analysis of this trial; they will read something like this: HOMEOPATHY PROVED TO BE SIGNIFICANTLY MORE EFFECTIVE THAN USUAL CARE. I have asked the question before and I do it again: when does this sort of ‘research’ cross the line into the realm of scientific misconduct?
