MD, PhD, FMedSci, FRSB, FRCP, FRCPEd

medical ethics

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?

This post will probably work best, if you have read the previous one describing how the parallel universe of acupuncture research insists on going in circles in order to avoid admitting that their treatment might not be as effective as they pretend. The way they achieve this is fairly simple: they conduct trials that are designed in such a way that they cannot possibly produce a negative result.

A brand-new investigation which was recently vociferously touted via press releases etc. as a major advance in proving the effectiveness of acupuncture is an excellent case in point. According to its authors, the aim of this study was to evaluate acupuncture versus usual care and counselling versus usual care for patients who continue to experience depression in primary care. This sounds alright, but wait!

755 patients with depression were randomised to one of three arms to 1)acupuncture, 2)counselling, and 3)usual care alone. The primary outcome was the difference in mean Patient Health Questionnaire (PHQ-9) scores at 3 months with secondary analyses over 12 months follow-up. Analysis was by intention-to-treat. PHQ-9 data were available for 614 patients at 3 months and 572 patients at 12 months. Patients attended a mean of 10 sessions for acupuncture and 9 sessions for counselling. Compared to usual care, there was a statistically significant reduction in mean PHQ-9 depression scores at 3 and 12 months for acupuncture and counselling.

From this, the authors conclude that both interventions were associated with significantly reduced depression at 3 months when compared to usual care alone.

Acupuncture for depression? Really? Our own systematic review with co-authors who are the most ardent apologists of acupuncture I have come across showed that the evidence is inconsistent on whether manual acupuncture is superior to sham… Therefore, I thought it might be a good idea to have a closer look at this new study.

One needs to search this article very closely indeed to find out that the authors did not actually evaluate acupuncture versus usual care and counselling versus usual care at all, and that comparisons were not made between acupuncture, counselling, and usual care (hints like the use of the word “alone” are all we get to guess that the authors’ text is outrageously misleading). Not even the methods section informs us what really happened in this trial. You find this hard to believe? Here is the unabbreviated part of the article that describes the interventions applied:

Patients allocated to the acupuncture and counselling groups were offered up to 12 sessions usually on a weekly basis. Participating acupuncturists were registered with the British Acupuncture Council with at least 3 years post-qualification experience. An acupuncture treatment protocol was developed and subsequently refined in consultation with participating acupuncturists. It allowed for customised treatments within a standardised theory-driven framework. Counselling was provided by members of the British Association for Counselling and Psychotherapy who were accredited or were eligible for accreditation having completed 400 supervised hours post-qualification. A manualised protocol, using a humanistic approach, was based on competences independently developed for Skills for Health. Practitioners recorded in logbooks the number and length of sessions, treatment provided, and adverse events. Further details of the two interventions are presented in Tables S2 and S3. Usual care, both NHS and private, was available according to need and monitored for all patients in all three groups for the purposes of comparison.

It is only in the results tables that we can determine what treatments were actually given; and these were:

1) Acupuncture PLUS usual care (i.e. medication)

2) Counselling PLUS usual care

3) Usual care

Its almost a ‘no-brainer’ that, if you compare A+B to B (or in this three-armed study A+B vs C+B vs B), you find that the former is more than the latter – unless A is a negative, of course. As acupuncture has significant placebo-effects, it never can be a negative, and thus this trial is an entirely foregone conclusion. As, in alternative medicine, one seems to need experimental proof even for ‘no-brainers’, we have some time ago demonstrated that this common sense theory is correct by conducting a systematic review of all acupuncture trials with such a design. We concluded that the ‘A + B versus B’ design is prone to false positive results…What makes this whole thing even worse is the fact that I once presented our review in a lecture where the lead author of the new trial was in the audience; so there can be no excuse of not being aware of the ‘no-brainer’.

Some might argue that this is a pragmatic trial, that it would have been unethical to not give anti-depressants to depressed patients and that therefore it was not possible to design this study differently. However, none of these arguments are convincing, if you analyse them closely (I might leave that to the comment section, if there is interest in such aspects). At the very minimum, the authors should have explained in full detail what interventions were given; and that means disclosing these essentials even in the abstract (and press release) – the part of the publication that is most widely read and quoted.

It is arguably unethical to ask patients’ co-operation, use research funds etc. for a study, the results of which were known even before the first patient had been recruited. And it is surely dishonest to hide the true nature of the design so very sneakily in the final report.

In my view, this trial begs at least 5 questions:

1) How on earth did it pass the peer review process of one of the most highly reputed medical journals?

2) How did the protocol get ethics approval?

3) How did it get funding?

4) Does the scientific community really allow itself to be fooled by such pseudo-research?

5) What do I do to not get depressed by studies of acupuncture for depression?

One cannot very well write a blog about alternative medicine without giving full credit to the biggest and probably most determined champion of quackery who ever hugged a tree. Prince Charles certainly has done more than anyone else I know to let unproven treatments infiltrate real medicine. To honour his unique achievements, I am here presenting a fictitious interview with him. It never did take place, of course, and the questions I put to him are pure imagination. However, the ‘answers’ are in a way quite real: they have been taken unaltered from various speeches he made and articles he wrote. To avoid being accused of using dodgy sources which might have quoted him inaccurately or sympathetically, I have exclusively used HRH’s very own official website as a source for his comments. It seems safe to assume that HRH identifies with them more fully than with the many other statements he made on this subject.

I have not changed a single word in his statements and I have tried to avoid quoting him out of context; I did, however, take the liberty of putting sentences side by side which do not always originate from the same speech or article, i.e. I have used quotes from different communications to appear as though they originally were in sequence. It will be clear from the text that the fictitious interview is dated before Charles’ Foundation folded because of money laundering and fraud.

It is, of course, hugely tempting to comment on the various statements by Charles. However, I have resisted this temptation; I wanted the reader to enjoy his wisdom in its pure and unadulterated beauty. Anyone who feels like it will have plenty of opportunity to post comments, if they so wish.

To make clear what is what, my questions appear in italics, while his ‘answers’ are in Roman typeface.

 

Q I believe you have no training in science or medicine; yet you have long felt yourself expert enough to champion bizarre forms of therapies which many of our readers might call quackery.

As you know by now, this is an area to which I attach the greatest importance and where I have tried to make a particular contribution. For many years, the NHS has found complementary medicine an uncomfortable bedfellow – at best regarded as ‘fringe’ and in some quarters as ‘quack’; never viewed as a substitute for conventional medicine and rarely as a genuine partner in providing therapy.

I look back to the rather “lukewarm” response I received in 1983 as President of the British Medical Association when I first spoke about integration and complementary and alternative medicine. We have clearly travelled a very long way since that time.

Q Alternative medicine is mainly used by those who can afford it; at present, little of it is available on the NHS. Why do you want to change this situation? 

The very popularity of non-conventional approaches suggests that people are either dissatisfied with the kind of orthodox treatment they are receiving, or find genuine relief in such therapies. Whatever the case, it is only reasonable to try to identify the factors that are contributing to their increased use. And if advantages are found, clearly they should not be limited only to those people who can pay, but should be made more widely available on the NHS.

Q If with a capital “I”?

I believe it is because complementary and alternative approaches to healthcare bring a different emphasis to bear which often unlocks an individual’s inner resources to aid recovery or help to manage living with a serious chronic illness. It is also because complementary and alternative therapies often offer more effective and less intrusive ways of treating illness.

Q Really? Are you sure that they are more effective that conventional treatments? What is your evidence for that?

In 1997 the Foundation for Integrated Medicine, of which I am the president and founder, identified research and development based on rigorous scientific evidence as one of the keys to the medical establishment’s acceptance of non-conventional approaches. I believed then, as I do now, that the move to a more integrated provision of healthcare would ultimately benefit patients and their families.

Q But belief is hardly a good substitute for evidence. In this context, it is interesting to note that chiropractors and osteopaths received the same status as doctors and nurses in the UK. Is this another of your achievements? Was it based on belief or on evidence?

True healing is a synergy that comes not by courtesy of a medical diploma.

Q What do you mean?

As we know, the professions of Osteopathy and Chiropractice are now regulated in the same way as doctors and dentists, with their own Acts of Parliament. I’m very proud to have played a tiny role in trying to push for that Act of Parliament over the years. It has also been reassuring to see the progress being made by the other main complementary professions and I look forward to the further development of regulatory frameworks enabling high standards of training, clinical practice and professional behaviour.

Q Some might argue that statutory regulation made them not more professional but merely improved their status and thus prevented asking question about evidence. Why did they need to be regulated in that way?

The House of Lord’s Select Committee Report on Complementary and Alternative Medicine in 2000, quite sensibly recommended that only complementary professions which were statutorily regulated, or which had well-established arrangements for voluntary self-regulation, should be made available through the NHS.

Q Integrated healthcare seems to be your new buzz-word, what does it mean? Is it more than a passing fad?

Integrated Healthcare is, I believe, here to stay. The public want it and need it. It is not a takeover of the orthodox by CAM or the other way around, but is rather the bringing together of the best from both for the ultimate benefit of the patient.

Q Your lobby-group, Foundation for Integrated Medicine, what has it ever done to justify its existence?

In 1997 the steering group of The Foundation for Integrated Medicine (FIM), of which I am proud to be president, published a discussion document ‘Integrated Healthcare – A Way Forward for the Next Five Years?’

Q Sorry to interrupt, but if so many people are already using them, why do you feel compelled to promote unproven treatments even more? Why is ‘a way forward’ in promotion actually needed? Why did we need a lobby group like FIM?

Homoeopaths, osteopaths, reflexologists, acupuncturists, T’ai chi instructors, art therapists, chiropractors, herbalists and aromatherapists: these practitioners were working alongside NHS colleagues in acute hospitals, on children’s wards, in nursing homes and in particular in primary healthcare, in GP practices and health clinics up and down the country.

Q Exactly! Why then even more promotion of unproven treatments?

All well and good, perhaps, but if there are advantages in this approach, clearly they should not be limited only to those who can pay.

Q Yes, if again with a capital “I”, presumably . Anyway, do you believe these therapies should be tested like other treatments?

One of the obstacles always raised is that it is very difficult to trial complementary therapies in the rigorous randomised way that mainstream medicine deems to be the gold standard. This is ironic as there are, of course, un-evaluated orthodox practices which continue to be funded by the NHS.

Q Are you an expert on research methodology as well?

At the same time, we should be mindful that clinically controlled trials alone are not the only pre-requisites to apply a healthcare intervention. Consumer-based surveys can explore WHY people choose complementary and alternative medicine and tease out the therapeutic powers of belief and trust

These “rationalist selves” would be enormously relieved to see the effectiveness of these treatments proven through the “double-blind randomized controlled trial” – the gold-standard of medical research. However, we know that some complementary and alternative medicine disciplines (and indeed other forms of medical or surgical intervention) do not lend themselves to this research method.

Q Are you sure? This sounds like something someone who is ignorant of research methodology has told you.

… it has been suggested that we need a research method for complementary treatment that is, to use that awful expression, “fit for purpose”. Something that is entirely practical – what has been called “applied” research – which takes into account the whole person and the whole treatment as it is actually given in the surgery or the hospital. Something that might offer us a better idea of the cost-effectiveness of any given approach. It would also help to provide the right sort of evidence that health service commissioners require when they decide which services they wish to commission for their patients.

Q Hmm – anyway, would you promote unproven treatments even for serious conditions like cancer?

Two surveys have indicated that up to eighty per cent of cancer patients try alternative or complementary treatments at some stage following diagnosis and seventy-five per cent of patients would like to see complementary medicine available on the N.H.S.

Q Yes, but why the promotion?

There is a major role for complementary medicine in bowel cancer – as a support to more conventional approaches – in helping to prevent it through lifestyle changes, helping to boost our immune systems and in helping sufferers to come to terms with, and maintain, a sense of control over their own lives and wellbeing. My own Foundation For Integrated Medicine is, for example, involved in finding ways to integrate the best of complementary and alternative medicine.

Q And what do you understand by “the best”? In medicine, this term should mean “the most effective”, shouldn’t it?

Many cancer patients have turned to an integrated approach to managing their health, finding complementary therapies such as acupuncture, aromatherapy, reflexology and massage therapy extremely therapeutic. I know of one patient who turned to Gerson Therapy having been told that she was suffering from terminal cancer, and would not survive another course of chemotherapy. Happily, seven years later she is alive and well. So it is therefore vital that, rather than dismissing such experiences, we should further investigate the beneficial nature of these treatments.

Q Gerson? Is it ethical to promote an unproven starvation diet for cancer? 

…many patients use and believe in Gerson Therapy, yet more evidence needs to be available as to who might benefit or what adverse effects there might be. But, surely, we need to take a wider view of the most appropriate types of research methodology – a wider view of what research will help patients.

Q You are a very wealthy man; will you put your own money into the research that you regularly demand?

Complementary medicine is gaining a toehold on the rockface of medical science.

Q I beg your pardon.

Complementary medicine’s toehold is literally that, and it’s an inescapable fact that clinical trials, of the calibre that medical science demands, cost money. Figures from the Department of Complementary Medicine at the University of Exeter show that less than 8p out of every £100 of NHS funds for medical research was spent on complementary medicine. In 1998-99 the Medical Research Council spent no money on it at all, and in 1999 only 0.05% of the total research budget of UK medical charities went to this area.

Q HmmNature; you are very fond of all things natural, aren’t you?

The garden is designed to remind people of our interconnectedness with Nature and of the beneficial medicinal properties She provides through countless plants, flowers and trees. Throughout the 20th century so much ancient, accumulated, traditional wisdom has been thrown away – whether in the fields of medicine, architecture, agriculture or education. The baby was thrown out with the bathwater, so this garden is designed to bring the baby back again and to remind us of that priceless, traditional knowledge before we lose that rich store of Nature’s healing gifts for the benefit of our descendants.

When you think about it, what on earth is the point of throwing away our lifeline; of abandoning the priceless knowledge and wisdom accumulated over 1,000’s of years relating to the treatment of the human condition by natural means? It is sheer folly it seems to me to forget that we are a part of Nature and to imagine we can survive on this Earth as if we were merely a mechanical process divorced from, and in opposition to, the unity of the world around us.

Q …and herbalism?

Medical herbalists talk about ‘synergy’, the result of a complex mix of active ingredients in a plant that create a more powerful therapeutic effect together than if isolated. It’s a concept that has a wider application. As the 17th century poet John Donne famously wrote, “No man is an Island, entire of itself; every man is a piece of the Continent, a part of the main.”

Q I am not sure I understand; what does that mean?

Medical herbalists, who make up their own preparations from combinations of fresh or dried plants, believe that this mix within individual herbs as well as in traditional mixtures of plant medicines creates what is called synergy, in which all the chemical components contribute to the remedy’s specific therapeutic effects.

At a time when farmers everywhere are struggling to make ends meet, the development of a natural pharmacy of organically grown herbs offers an alternative means of earning a living. Yet without protective measures, herbs are easily adulterated or their quality compromised.

Q …and homeopathy?

I went to open the new Glasgow Homeopathic Hospital for instance a couple of years ago, I met a whole lot of students who were studying homeopathy, I think, and I’ve never forgotten when they said to me ‘Are you interested in homeopathy’ and I thought – I don’t know, why do I bother?

Q And why exactly do you bother, if I may ask?

By allowing patients treatment choice, negative emotions can, in part, be alleviated. Many complementary practitioners provide time, empathy, hope and reassurance – skills that are referred to as the “human effect” – which can improve the confidence of cancer patients, alter mindsets and produce major positive changes in the immune system. As a result the “human effect” can greatly prolong life: it has been demonstrated that in a variety of cancers, such as breast cancer, that attitude of mind can not only raise the quality of life but in some cases can even prolong life. At the same time, we need specific treatments that are designed to improve the quality of patients’ lives, and to provide relief from the unpleasant symptoms of cancer – anxiety; pain; sleeplessness; skin irritation; poor appetite; nausea and depression, to name but a few.

Q At heart you seem to be a vitalist who believes in a vital force or energy that interconnects anything with everything and determines our health.

Research in the new field of psychoneuroimmunology – or mind-body medicine as it is sometimes called – is discovering that there is a constant interplay between our emotions, thoughts and actions and our body systems. It seems that the food we eat, the air we breathe, the exercise we take, our relationships with other people, all have a direct bearing on our health and natural healing processes. Complementary medicine has always known this and I believe it is one of the reasons for its enormous popularity.

Q Clarence House made several statements assuring the British public that you never overstep your constitutional role by trying to influence health politics; they were having us on, weren’t they?

A few days ago I launched an initiative to promote the provision of more complementary medicine in the NHS. For many years I have been working towards this goal.

Q Does that mean these statements were wrong?

I am convinced there is no better moment than now to create a real integration of our healthcare, particularly when there is talk of a Patient-Centred NHS. So much ill-health and disease is due to the misery, stress and alienation we see in our community.

I have said it so often that I hesitate to state it again: an uncritical researcher is a contradiction in terms. This begs the question as to how critical the researchers of alternative medicine truly are. In my experience, most tend to be uncritical in the extreme. But how would one go about providing evidence for this view? In a previous blog-post, I have suggested a fairly simple method: to calculate an index of negative conclusions drawn in the articles published by a specific researcher. This is what I wrote:

If we calculated the percentage of a researcher’s papers arriving at positive conclusions and divided this by the percentage of his papers drawing negative conclusions, we might have a useful measure. A realistic example might be the case of a clinical researcher who has published a total of 100 original articles. If 50% had positive and 50% negative conclusions about the efficacy of the therapy tested, his trustworthiness index (TI) would be 1.

Depending on what area of clinical medicine this person is working in, 1 might be a figure that is just about acceptable in terms of the trustworthiness of the author. If the TI goes beyond 1, we might get concerned; if it reaches 4 or more, we should get worried.

An example would be a researcher who has published 100 papers of which 80 are positive and 20 arrive at negative conclusions. His TI would consequently amount to 4. Most of us equipped with a healthy scepticism would consider this figure highly suspect.

So how would alternative medicine researchers do, if we applied this method for assessing their trustworthiness? Very poorly, I fear – but that is speculation! Let’s see some data. Let’s look at one prominent alternative medicine researcher and see. As an example, I have chosen Professor George Lewith (because his name is unique which avoids confusion with researchers), did a quick Medline search to identify the abstracts of his articles on alternative medicine, and extracted the crucial sentence from the conclusions of the most recent ones:

  1.  The study design of registered TCM trials has improved in estimating sample size, use of blinding and placebos
  2.  Real treatment was significantly different from sham demonstrating a moderate specific effect of PKP
  3. These findings highlight the importance of helping patients develop coherent illness representations about their LBP before trying to engage them in treatment-decisions, uptake, or adherence
  4. Existing theories of how context influences health outcomes could be expanded to better reflect the psychological components identified here, such as hope, desire, optimism and open-mindedness
  5. …mainstream science has moved on from the intellectual sterility and ad hominem attacks that characterise the sceptics’ movement
  6. Trustworthy and appropriate information about practitioners (e.g. from professional regulatory bodies) could empower patients to make confident choices when seeking individual complementary practitioners to consult
  7. Comparative effectiveness research is an emerging field and its development and impact must be reflected in future research strategies within complementary and integrative medicine
  8. The I-CAM-Q has low face validity and low acceptability, and is likely to produce biased estimates of CAM use if applied in England, Romania, Italy, The Netherlands or Spain
  9.  Our main finding was of beta power decreases in primary somatosensory cortex and SFG, which opens up a line of future investigation regarding whether this contributes toward an underlying mechanism of acupuncture.
  10. …physiotherapy was appraised more negatively in the National Health Service than the private sector but osteopathy was appraised similarly within both health-care sectors

This is a bit tedious, I agree, so I stop after just 10 articles. But even this short list does clearly indicate the absence of negative conclusions. In fact, I see none at all – arguably a few neutral ones, but nothing negative. All is positive in the realm of alternative medicine research then? In case you don’t agree with that assumption, you might prefer to postulate that this particular alternative medicine researcher somehow avoids negative conclusions. And if you believe that, you are not far from considering that we are being misinformed.

Alternative medicine is not really a field where one might reasonably expect that rigorous research generates nothing but positive results; even to expect 50 or 40% of such findings would be quite optimistic. It follows, I think, that if researchers only find positives, something must be amiss. I have recently demonstrated that the most active research homeopathic group (Professor Witt from the Charite in Berlin) has published nothing but positive findings; even if the results were not quite positive, they managed to formulate a positive conclusion. Does anyone doubt that this amounts to misinformation?

So, I do have produced at least some tentative evidence for my suspicion that some alternative medicine researchers misinform us. But how precisely do they do it? I can think of several methods for avoiding publishing a negative result or conclusion, and I fear that all of them are popular with alternative medicine researchers:

  • design the study in such a way that it cannot possibly give a negative result
  • manipulate the data
  • be inventive when it comes to statistics
  • home in on to the one positive aspect your generally negative data might show
  • do not write up your study; like this nobody will ever see your negative results

And why do they do it? My impression is that they use science not for testing their interventions but for proving them. Critical thinking is a skill that alternative medicine researchers do not seem to cultivate. Often they manage to hide this fact quite cleverly and for good reasons: no respectable funding body would give money for such an abuse of science! Nevertheless, the end-result is plain to see: no negative conclusions are being published!

There are at least two further implications of the fact that alternative medicine researchers misinform the public. The first concerns the academic centres in which these researchers are organised. If a prestigious university accommodates a research unit of alternative medicine, it gives considerable credence to alternative medicine itself. If the research that comes out of the unit is promotional pseudo-science, the result, in my view, amounts to misleading the public about the value of alternative medicine.

The second implication relates to the journals in which researchers of alternative medicine prefer to publish their articles. Today, there are several hundred journals specialised in alternative medicine. We have shown over and over again that these journals publish next to nothing in terms of negative results. In my view, this too amounts to systematic misinformation.

My conclusion from all this is depressing: the type of research that currently dominates alternative medicine is, in fact, pseudo-research aimed not at rigorously falsifying hypotheses but at promoting bogus treatments. In other words alternative medicine researchers crucially contribute to the ‘sea of misinformation’ in this area.

If my health insurance pays for this treatment, it must be scientifically tested and proven. The ‘appeal to authority’ is powerful indeed, and I imagine that many consumers fall for this argument. But it is a fallacy! Health insurances are misinforming us for commercial benefit.

In 2007, I published an analysis of German health insurance companies’ policies regarding bogus treatments (MMW 2006, 149: 55-56 [the paper is in German and unfortunately not Medline-listed]). For this purpose, I had selected three popular alternative modalities: Bach flower remedies, Schuessler salts, and kinesiology all of which are, of course, not supported by sound evidence nor by biological plausibility. What emerged from this evaluation was shocking: of the 13 companies analysed, 9 paid for Bach flower remedies, 7 for kinesiology and 9 for Schuessler salts.

If you now think ‘ah yes, those Germans are obsessed with alternative medicine’, think again. The situation in most other countries is not much better; health insurances go for alternative medicine as though there is no tomorrow. A review from the US concluded that the number of people using CAM insurance benefits was substantial; the effect on insurance expenditures was modest. Because the long-term trajectory of CAM cost under third-party payment is unknown, utilization of these services should be followed. And apparently this is by no means confined to human health; recently someone tweeted that he had a very hard time finding a pet-insurance which did not offer to cover woo.

A few years after the above-mentioned publication, I was invited to speak at an international meeting of health insurers. I told the delegates in no uncertain terms that most of what they were offering to their clients in terms of alternative medicine was either unproven or disproven. There was stunned silence during the official discussion period, and I asked myself whether I had impolitely embarrassed my hosts. Then came the tea break, and one high-level representative of an insurance company after the other came to me to chat. Essentially, they all said: “We are well aware of the facts and the evidence you reviewed in your lecture; most of these treatments are useless, of course. But we have to offer them to our customers because we need to be competitive.”

In other words, health insurers, who normally are keen to keep their costs down, do not mind to pay for treatments which they know are ineffective simply because they use it as some sort of an advertising gimmick. In doing so they say or imply that these treatments do work. I think this is not just wrong and short-sighted, it is unethical and it significantly contributes to the ‘sea of misinformation’.

It almost goes without saying that alternative practitioners contribute importantly to the ‘sea of misinformation’ about alternative medicine. Again, I could write books about this subject but have to refrain myself and therefore will merely put quick spotlights on several types of practitioners, mostly drawing from my own research on these subjects.

Acupuncturists

A survey of more than 9000 patients of U.K. non-medically trained acupuncturists showed that a considerable number had received advice from their therapists about prescribed medicines. Since these acupuncturists hold no medical qualifications, they are not qualified to issue such advice. It is therefore clear to me that the advice given is likely to be misleading. In 2000, we directly asked the U.K. acupuncturists’ advice about electro-acupuncture treatment for smoking cessation, a treatment which we previously had identified to be ineffective. The advice we received was frequently not based on current best evidence and some of it also raised serious safety concerns (Schmidt, K., & Ernst, E. Internet advice by acupuncturists—a risk factor for cardiovascular patients? Perfusion,2002, 15: 44-50. Article not Medline-listed).

Chiropractors

Many chiropractors from the UK and other countries make unsustainable therapeutic claims on their websites. In 2002, at the height of the ‘‘MMR scare’’ in Britain, we conducted a study revealing that a sizable proportion of U.K. chiropractors advised mothers against having the measles-mumps-rubella (MMR) jab for their children. A survey of the U.K. chiropractors demonstrated that an alarming percentage of the U.K. chiropractors fail to provide advice about the risks of spinal manipulation before commencing treatment. As these risks are, in fact, considerable, this behaviour amounts to misinformation and is an obvious violation of medical ethics.

Osteopaths

With osteopaths, it is a very similar story; the main difference is that there are far less investigations than for chiropractors. This may be due to the fact that, in the US, osteopaths are not alternative but conventional clinicians with much the same training and skills as proper doctors. But in Europe, they are strictly alternative and make as many bogus claims as chiropractors. Systematic investigations are rare, but I only need to remind us of my recent blog-post where I pointed out that:

Most osteopaths treat children for a wide range of conditions and claim that their interventions are helpful. They believe that children are prone to structural problems which can be corrected by their interventions. Here is an example from just one of the numerous promotional websites on this topic:

STRUCTURAL  PROBLEMS, such as those affecting the proper mobility and function of the  body’s framework, can lead to a range of problems. These may include:

  • Postural – such as scoliosis
  • Respiratory  – such as asthma
  • Manifestations of brain  injury – such as cerebral palsy and spasticity
  • Developmental  – with delayed physical or intellectual progress, perhaps triggering learning  behaviour difficulties
  • Infections – such  as ear and throat infections or urinary disturbances, which may be recurrent.

OSTEOPATHY can assist in the prevention of health problems, helping children to make a smooth  transition into normal, healthy adult life.

Herbalists

Encouraging evidence exists for some specific herbs in the treatment of some specific conditions. Yet, virtually no good evidence exists to suggest that the prescriptions of individualized herbal mixtures by traditional herbalists across the globe generate more good than harm. Despite this lack of evidence, herbalists do not seem to offer this information voluntarily to his or her patients. When we directly asked the UK herbalists for advice on a clinical case, we found that it was ‘‘misleading at best and dangerous at worst’’ . In other words, herbalists misinform their patients and the public about the value of their treatments.

Homeopaths

Many non-medically trained homeopaths advise their clients against the immunization of children. Instead, these practitioners often recommend using ‘‘homeopathic vaccinations’’ for which no good evidence exists. For instance, the vice-chair of the board of directors of ‘‘The Society of Homeopaths’’ had a site with the following statements: ‘‘Homeopathic alternatives to children’s immunisation are now available.’’ ‘‘Our clinic offers alternative immunisation programmes for the whole family.’’ Such statements amounts to misinformation which puts children’s health at risk.

Other alternative practitioners

I have chosen the above-listed professions almost at random and could have selected any other type as well. Arguably, all alternative practitioners who employ unproven treatments – and that must be the vast majority – misinform their patients to some extend. The only way to avoid this is to say: ‘look, I am going to give you a therapy for which there is no good evidence – I hope you don’t mind’. If they did that, they would be out of business in a flash. It follows, I think, that being in business is tantamount to misleading patients.

And there is, of course, another way of misinforming patients which is often forgotten yet very important: withholding essential information. In all of health care, informed consent is a ‘sine qua non’. Alternative practitioners very rarely obtain informed consent from their patients. The reason seems obvious (see above). I would argue that not informing people when they should be informed is a form of misinformation.

In this context, it is worth mentioning an investigation we did in 2009: We obtained the ethical codes of the following bodies: Association of Naturopathic Practitioners, Association of Traditional Chinese Medicine (UK), Ayurvedic Practitioners Association, British Acupuncture Council, Complementary and Natural Healthcare Council, European Herbal Practitioners Association, General Chiropractic Council, General Osteopathic Council, General Regulatory Council for Complementary Therapies, National Institute of Medical Herbalists, Register of Chinese Herbal Medicine, Society of Homeopaths, UK Healers, Unified Register of Herbal Practitioners. We then extracted the statements from these codes referring to evidence-based practice (EBP). The results showed that only the General Chiropractic Council, the General Osteopathic Council and the General Regulatory Council for Complementary Therapies oblige their members to adopt EBP.

Conclusion

It seems that misinformation is an alternative practitioner’s daily bread. Without it, alternative therapists would need to confine their practice to the few treatments/conditions for which the evidence is positive. If they ever followed this strategy, they would hardly be able to earn a living.

To include conventional health care professionals amongst those who significantly contribute to the ‘sea of misinformation’ on alternative medicine might come as a surprise. But sadly, they do deserve quite a prominent place in the list of contributors. In fact, I could write one entire book about each of the various professions’ ways to mislead patients about alternative medicine.

There are, of course, considerable national differences and other peculiarities which render each specific profession quite complex to evaluate. The material is huge – far to big to fit in a short comment. All I will therefore try to do with this post is to throw a quick spotlight on some of the mainstream professions mentioning just one or two relevant aspects in each instant.

Nurses

Particularly in North America, many nurses seem to be besotted with ‘Therapeutic Touch’, an implausible and unproven ‘energy-therapy’. For instance, the College of Nurses of Ontario includes Therapeutic Touch as a therapy permitted for its members. In other regions, other alternative treatments might be more popular with nurses but, in general, many seem to have a weakness for this sector. Researchers from Aberdeen  recently conducted a survey to establish the use of alternative medicine by registered nurses, as well as their knowledge-base and attitudes towards it. They sent a questionnaire to 621 nurses and achieved a remarkable response rate of 86%. Eighty per cent of the responders admitted to employ alternative medicine and 41% were using it currently. Only five nurses believed that alternative medicine was not effective and 74% would recommend it to others. In other words, there is a strong likelihood of patients being misinformed by nurses.

Midwives

A recent article in the UK journal THE PRACTISING MIDWIFE (Sept 2013) by Valerie Smith (not Medline-listed) claimed that the Royal College of Midwives supports the use of homeopathic remedies during childbirth. This does come to no surprise to those who know that several surveys have suggested that midwives are particularly fond of un- or dis-proven therapies and that they employ them often without the knowledge of obstetricians. We investigated this question by conducting a systematic review of all surveys of alternative medicine use by midwives. In total,19 surveys met our inclusion criteria. Most were recent and many originated from the US. Prevalence data varied but were usually high, often close to 100%. Much of this practice was not supported by sound evidence for efficacy and some of the treatments employed had the potential to put patients at risk. It seems obvious that, in order to employ unproven treatment, midwives first need to misinform their patients.

Physiotherapists

Some physiotherapists promote and practise a range of unproven treatments, e.g. craniosacral therapy. I am not aware of statistics on this, but it is not difficult to find evidence on the Internet: One website boldly states that Physiotherapy & Craniosacral Therapy available with Charetred Physiotherapist with 20 years of experience in the NHS. Another one proudly announces:  Our main methods of treatment are through Physiotherapy and Craniosacral Therapy. A third site claims that Craniosacral Therapy is attracting increasing interest for its gentle yet effective approach, working directly with the body’s natural capacity for self-repair to treat a wide range of conditions. And a final example: Catherine is a registered Cranio-Sacral Therapist, a Physiotherapist, and is a tutor at the London College of Cranio-Sacral Therapy.  She is also qualified in acupuncture for pain relief and a member of the Craniosacral Therapy Association, the Chartered Society of Physiotherapy and Acupuncture Association for Chartered Physiotherapists.

Pharmacists

If you go into any pharmacy in the UK, you do not need to search for long to find shelves full of homeopathic remedies, Bach flower remedies, aromatherapy-oils or useless herbal slimming aids, to mention just 4 of the many different bogus treatments on offer. If you do the same in Germany, France, Switzerland or other countries, the amount of bogus remedies and devices for sale might even be greater. Pharmacists, it seems to me, have long settled to be shopkeepers who have few scruples misleading their customers into believing that these useless products are worth buying. Their code of ethics invariably forbids them such promotion and trade, but most pharmacists seem to pay no or very little attention. The concern for profit has clearly won over the concern for customers or patients.

Doctors

I have left my own profession for last – not because they are the least contributors to the ‘sea of misinformation, but because, in some respects, they are the most important ones. The general attitude amongst doctors today seems to be ‘I don’t care how it works, as long as it helps my patients’. I have dedicated a previous post on explaining that this is misleading nonsense; therefore there is no reason to not repeat myself. Instead, I might just mention how many doctors practice homeopathy thus misleading patients into believing that it is an effective therapy. Alternatively, I could refer to those charlatans with a medical degree who promote bogus cancer cures. In my view, misinformation by doctors is the most serious form of misinformation of them all: physicians involved in such activities violate their ethical code and betray patients who frequently trust doctors almost blindly.

Conclusion

It would be a misunderstanding to assume that, with this post, I am accusing all conventional health care professionals of misinforming us about alternative medicine. But some clearly do; and when they do abuse their positions of trust in this way, they do a serious disservice to us all. I hope that exposing this problem will contribute to conventional health care professionals behaving more responsibly in future.

Imagine: you consult your doctor and he says:  “I am so sorry, but I have bad news: the tests have shown that you have cancer”. You go home and feel as though someone has hit you with a sledge hammer. You cry a lot and your thoughts go round in circles. A complete nightmare unfolds; you sometimes think you are dreaming but reality soon catches up with you.

A few days later, you have an appointment with the oncologist who explains the treatment plan. You feel there is no choice and you agree to it. After the first chemotherapy, you lose your hair, your well-being, your dignity, your control and your patience – time to investigate what else there is on offer. There must be an alternative!

By then lots of well-wishers will have mentioned to you that the conventional route is but one of many: there are, in fact, alternatives!!! You go on the internet and find not just a few, you find millions of website promoting hundreds of solutions – anything from diets to herbal remedies, from homeopathy to faith-healing. All are being promoted as cures for your cancer, and all are free of those nasty side-effects which make your life hell at the moment. You think “there is a choice after all”.

Who would not be tempted by these options advertised in the most glorious terms? Who would not begin to distrust the oncologists who kindly but firmly insist that ‘alternative cancer cures’ are bogus? Who would not want to get rid of the cancer and the side-effects in one genial master-stroke?

Cancer patients yearn for hope and are extremely vulnerable to such influences.  I do not know a single one who, faced with the diagnosis and all it entails, has not looked at the ‘alternatives’. This is why it would be so very important that the websites informing patients and their carers convey accurate and responsible information. But do they?

One of our research projects at Exeter had been aimed at assessing the quality of the websites advising patients on alternative treatments for cancer. For this purpose, we evaluated a total of 32 sites which cancer patients were most likely to consult according to pre-defined criteria – in other words, we assessed the most frequented websites for cancer.

Our results were shocking: many of these sites were of poor quality and most of them recommended a plethora of unproven treatments for cancer, most frequently herbal remedies, diets and mind-body therapies. In our estimation, at least three of them were outright dangerous and had the potential to harm patients.

The level of misinformation in this area is sickening. Patients are being sold false hope by the truck-load. Yet they deserve better; they deserve impartial information on their illness and the best treatment for it – cancer patients especially so. What they get instead is a total disgrace: commercially driven lies about ‘treatments’ which are not just unproven but which would, if used as instructed, hasten their death. Some alternative therapies have potential for palliative and supporting care, BUT NONE OFFER A CURE OR A REDUCTION OF THE TUMOR BURDEN OR A CHANGE IN THE NATURAL HISTORY OF THE DISEASE.

The UK ‘Society of Homeopaths’ (SoH) is the largest professional organisation of UK non-doctor, so-called lay- homeopaths. On their website, the SoH made very specific claims about homeopathy; in particular, they listed conditions for which homeopathy had allegedly been proven to be effective. These claims have now thoroughly been debunked, and the evidence the SoH produced in support of their claims has been shown to be misleading, cherry-picked or misinterpreted.

I have no idea who conducted the above-named investigation and made a youtube video of it, but I think it is essentially correct and well worth watching. My own experiences with the SoH relate mainly to two encounters.

The first was a complaint I made about one of their high-ranking officers, Ralf Jeutter. He had been promotiong homeopathic vaccinations on his website (needless to stress, I think, that there is no evidence to support the notion that homeopathic vaccinations are effective). As I felt that the SoH dragged their feet pursuing my complaint, I had to send several reminders. Eventually, they considered it and concluded that Reuter had done nothing wrong. This, presumably, is the reason why, even today, he can state on his website that Homeopathy is used to help individuals in dealing better with kinds of infections such as leptospirosis, meningitis and cholera. All is fine, it seems as long as a disclaimer is added: Any information obtained here is not to be construed as medical OR legal advice. The decision to vaccinate and how you implement that decision is yours and yours alone. The evidence for the efficacy of homeopathic immunisation is ‘anecdotal’. That means it is based on individuals’ reports past and present.

My second encounter with the SoH relates to my 2010 analysis of the SoH code of ethics and their adherence to it. The code demanded that:

 

  • ‘all speculative theories will be stated as such and clearly distinguished’
  • ‘no advertising may be used which expressly or implicitly claims to cure named diseases’
  • ‘Advertising shall not be false, fraudulent, misleading, deceptive, extravagant or sensational.’

Encouraged by these assurances, I decided to study the websites of some members of the SoH, and soon discovered numerous and very obvious violations of the above-mentioned imperatives. In an attempt to find the root of these transgressions, I scrutinised the SoH’s own website where I found a multitude violations on all levels of the SoH’s own code of ethics. Many of the violations related to claims which were not supported by evidence. In other words, the largest professional UK organisation of lay- homeopaths misled the public in several rather devious ways:

  • they pretended to adhere to a code of ethics which forbids members to mislead the public
  • SoH -members nevertheless did mislead the public in ways that public health at risk
  • and they did so not least because the SoH followed exactly the same strategy
  • thus the SoH violated its own code of ethics to the detriment of public health.

My analysis was conducted a while ago, and some might hope that the SoH has stopped systematically misleading the public. This hope, however, is harshly disappointed when you watch the brand-new video entitled TESTING HOMEOPATHY mentioned above. As the SoH is about to celebrate 35 years of wisdom, courage, knowledge and prosperity, I do wonder whether this should not be 35 years of dangerously misleading the public.

What do you think?

 

 

Quite a few people seem to be amazed about the amount of work and the enthusiasm I invest into this blog. To be honest, I am amazed too. Why do I do it? And why do I do it in the way I do it?

I am sure that my critics have a choice of answers at the ready; in one way or another, the following theories have been put forward:

  1. I was bought by the pharmaceutical industry.
  2. I have had a bad experience with one or several alternative practitioners.
  3. I want to get rich and/or famous.
  4. I feel that conventional medicine is flawless
  5. I don’t know what I am writing about.

None of these notions is remotely true, of course.

Big Pharma has never approached me, and so far nobody at all has ever tried to influence the contents of my posts. I never had a bad personal experience with alternative medicine; on the contrary, I had several quite positive ones. The blog does not earn me money; it even costs a little to run it, and nobody other than I pay for it. I do not think that fame is something one can achieve through doing a blog, and I certainly do not aim at doing so. Sadly, I know only too well about the many flaws in conventional medicine; it is often far from perfect but at least it makes progress; alternative medicine, by contrast, seems almost entirely static. As I have studied most aspects of alternative medicine for two decades and published more than any other person on this subject, I think the allegation of incompetence might be a bit far-fetched.

So, why then?

When I decided to become a doctor I, like most medical students, did so mainly to help suffering individuals. When I became a researcher, I felt more removed from this original ideal. Yet I told myself that, by conducting research, I might eventually contribute to a better health care of tomorrow. Helping suffering patients was still firmly on the agenda. But then I realised that my articles in peer-reviewed medical journals somehow missed an important target: in alternative medicine, one ought to speak not just to health care professionals but also to consumers and patients; after all, it is they who often make the therapeutic decisions in this area.

Once I had realised this, I started addressing the general public by writing for The Guardian and other newspapers, giving public lectures and publishing books for a lay audience, like TRICK OR TREATMENT…The more I did this sort of thing, the more I noticed how important this activity was. And when a friend offered to help me set up a blog, I did not hesitate for long.

So, the reason for my enthusiasm for this blog turns out to be the same as the one that enticed me to go into medicine in the first place. I do believe that it is helpful for consumers to know the truth about alternative medicine. Considering the thousands of sources of daily misinformation in this area, there is an urgent need for well-informed, critical information. By providing it, I am sure I can assist people to make better therapeutic decisions. In a way, I am back where I started all those years ago: hoping to help suffering patients in the most direct way my expertise allows.

Gravityscan Badge

Recent Comments

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


Click here for a comprehensive list of recent comments.

Categories