MD, PhD, FMedSci, FRSB, FRCP, FRCPEd

bogus claims

Whenever we consider alternative medicine, we think of therapeutic interventions and tend to forget that alternative practitioners frequently employ diagnostic methods which are alien to mainstream health care. Acupuncturists, iridologists, spiritual healers, massage therapists, reflexologists, applied kinesiologists, homeopaths, chiropractors, osteopaths and many other types of alternative practitioners all have their very own ways of diagnosing what might be wrong  with their patients.

The purpose of a diagnostic test or technique is, of course, to establish the presence or absence of an abnormality, condition or disease. Conventional doctors use all sorts of validated diagnostic methods, from physical examination to laboratory tests, from blood pressure measurements to X-rays. Alternative practitioners use mostly alternative methods for arriving at a diagnosis, and we should ask: how reliable are these techniques?

Anyone trying to answer this question, will be surprised to find how very little reliable information on this topic exists. Scientific tests of the validity of alternative diagnostic tests are a bit like gold dust. And this is why a recently published article is, in my view, of particular importance and value.

The aim of this study was to evaluate the inter-rater reliability of pulse-diagnosis as performed by Traditional Korean Medicine (TKM) clinicians. A total 658 patients with stroke who were admitted into Korean oriental medical university hospitals were included. Each patient was seen by two TKM-experts for an examination of the pulse signs – pulse diagnosis is regularly used by practitioners of TKM and Traditional Chinese Medicine (TCM), and is entirely different from what conventional doctors do when they feel the pulse of a patient. Inter-observer reliability was assessed using three methods: simple percentage agreement, the kappa value, and the AC(1) statistic. The kappa value indicated that the inter-observer reliability in evaluating the pulse signs ranged from poor to moderate, whereas the AC(1) analysis suggested that agreement between the two experts was generally high (with the exception of ‘slippery pulse’). The kappa value indicated that the inter-observer reliability was generally moderate to good (with the exceptions of ‘rough pulse’ and ‘sunken pulse’) and that the AC(1) measure of agreement between the two experts was generally high.

Based on these findings, the authors drew the following conclusion: “Pulse diagnosis is regarded as one of the most important procedures in TKM… This study reveals that the inter-observer reliability in making a pulse diagnosis in stroke patients is not particularly high when objectively quantified. Additional research is needed to help reduce this lack of reliability for various portions of the pulse diagnosis.”

This indicates, I think, that the researchers (who are themselves practitioners of TCM!) are not impressed with the inter-rater reliability of the most commonly used diagnostic tool in TCM/TKM. Imagine this to be true for a commonly used test in conventional medicine; imagine, for instance, that one doctor measuring your blood pressure produces entirely different readings than the next one. Hardly acceptable, don’t you think?

And, of course, inter-rater reliability would be only one of several preconditions for their diagnostic methods to be valid. Other essential preconditions for diagnostic tests to be of value are their specificity and their sensitivity; do they discriminate between healthy and unhealthy, and are they capable of differentiating between severely abnormal findings and those that are just a little out of the normal range?

Until we have answers to all the open questions about each specific alternative diagnostic method, it would be unwise to pretend these tests are valid. Imagine a doctor prescribing a life-long anti-hypertensive therapy on the basis of a blood pressure reading that is little more than guess-work!

Since non-validated diagnostic tests can generate both false positive and false negative results, the danger of using them should not be under-estimated. In a way, invalid diagnostic tests are akin to bogus bomb-detectors (which made headlines recently): both are techniques to identify a problem. If the method generates a false positive result, an alert will be issued in vain, people will get anxious for nothing, time and money will be lost, etc. If the method generates a false negative result, we will assume to be safe while, in fact, we are not. In extreme cases, such an error will cost lives.

It is difficult to call those ‘experts’ who advocate using such tests anything else than irresponsible, I’d say. And it is even more difficult to have any confidence in the treatments that might be administered on the basis of such diagnostic methods, wouldn’t you agree?

Some national and international guidelines advise physicians to use spinal manipulation for patients suffering from acute (and chronic) low back pain. Many experts have been concerned about the validity of this advice. Now an up-date of the Cochrane review on this subject seems to provide clarity on this rather important matter.

Its aim was to assess the effectiveness of spinal manipulative therapy (SMT) as a treatment of acute low back pain. Randomized controlled trials (RCTs) testing manipulation/mobilization in adults with  low back pain of less than 6-weeks duration were included. The primary outcome measures were pain, functional status and perceived recovery. Secondary endpoints were return-to-work and quality of life. Two authors independently conducted the study selection, risk of bias assessment and data extraction. The effects were examined for SMT versus  inert interventions, sham SMT,  other interventions, and for SMT as an adjunct to other forms of treatment.

The researchers identified 20 RCTs with a total number of 2674 participants, 12 (60%) RCTs had not been included in the previous version of this review. Only 6 of the 20 studies had a low risk of bias. For pain and functional status, there was low- to very low-quality evidence suggesting no difference in effectiveness of SMT compared with inert interventions, sham SMT or as adjunct therapy. There was varying quality of evidence suggesting no difference in effectiveness of SMT compared with other interventions. Data were sparse for recovery, return-to-work, quality of life, and costs of care.

The authors draw the following conclusion: “SMT is no more effective for acute low back pain than inert interventions, sham SMT or as adjunct therapy. SMT also seems to be no better than other recommended therapies. Our evaluation is limited by the few numbers of studies; therefore, future research is likely to have an important impact on these estimates. Future RCTs should examine specific subgroups and include an economic evaluation.”

In other words, guidelines that recommend SMT for acute low back pain are not based on the current best evidence. But perhaps the situation is different for chronic low back pain? The current Cochrane review of 26 RCTs is equally negative: “High quality evidence suggests that there is no clinically relevant difference between SMT and other interventions for reducing pain and improving function in patients with chronic low-back pain. Determining cost-effectiveness of care has high priority. Further research is likely to have an important impact on our confidence in the estimate of effect in relation to inert interventions and sham SMT, and data related to recovery.”

This clearly begs the question why many of the current guidelines seem to mislead us. I am not sure I know the answer to this one; however I suspect that the panels writing the guidelines might have been dominated by chiropractors and osteopaths or their supporters who have not exactly made a name for themselves for being impartial. Whatever the reason, I think it is time for a re-think and for up-dating guidelines which are out of date and misleading.

Similarly, it might be time to question for what conditions chiropractors and osteopaths, the two professions who use spinal manipulation/mobilisation most, do actually offer anything of real value at all. Back pain and SMT are clearly their domains; if it turns out that SMT is not evidence-based for back pain, what is left? There is no good evidence for anything else, as far as I can see. To make matters worse, there are quite undeniable risks associated with SMT. The conclusion of such considerations is, I fear, obvious: the value of and need for these two professions should be re-assessed.

Evidence-based medicine (EBM) is a tool which enables health care professionals to optimize the chances for patients to be treated according to ethically, legally and medically accepted standards. Many proponents of alternative medicine used to reject the principles of EBM, not least because there is precious little good evidence from reliable clinical trials to support their treatments. In recent years, however, some alternative practitioners have stopped trying to swim against the tide.

They have discreetly changed their tune claiming that they do, in fact, practice EBM. Their argument usually holds that EBM represents much more than just data from clinical trials and that they actually do abide by the rules of EBM when treating their patients. The former claim is correct but the latter is not.

In order to explain why, we ought to first define our terminology. During recent years, several descriptions of EBM have become available. According to David Sackett,  who was part of the McMaster group that coined the term, EBM is “the conscientious, explicit and judicious use of current best evidence in making decisions about the care of individual patients. The practice of evidence-based medicine means integrating individual clinical experience with the best available external clinical evidence from systematic research”. As proposed by Sackett, the practice of  EBM rests on the following three pillars:

  • External Evidence– clinically relevant and reliable research mostly from clinical investigations into the efficacy and safety of therapeutic interventions – in other words clinical trials and systematic reviews. In a previous blog-post, I have elaborated on the question what evidence means.
  • Clinical Expertise– the ability to use clinical skills to identify each patient’s unique health state, diagnosis and risks as well as his/her chances to benefit from the available therapeutic options.
  • Patient Values– the individual preferences, concerns and expectations of the patient which are important in order to meet the patient’s needs.

So, how can a homeopath treating a patient with migraine, a chiropractor manipulating a child with asthma, or an acupuncturist needling a consumer for smoking cessation claim to practice EBM? The best available external evidence shows that neither of these therapies is effective. In fact, it even suggests that these options are ineffective for the above-named indications.

Using the first example of the homeopath, the scenario goes something like this: a homeopath believes in the ability of homeopathy and has the clinical expertise in it (he probably has clinical expertise in nothing else but homeopathy). His patient’s preference is very clearly with homeopathy (otherwise, she would not have consulted him). It follows that the homeopath does embrace two pillars of EBM. As to the third pillar – external evidence – he is adamant that clinical trials cannot do justice to something as holistic, subtle, individualized etc. Therefore he refuses to recognize the trial data as conclusive and rather trusts his experience which might be substantial.

I am sure that this line of arguing can convince some people; it certainly seems to appear compelling to those alternative practitioners who claim to practice EBM. However, I cannot agree with them.

The reason is simple: the practice of EBM must rest on three pillars, and each one of those three pillars is essential; we cannot just pick the ones we happen to like and drop the ones which we find award, we need them all.

We might be generous and grant that the homeopath’s pseudo-EBM argument outlined above suggests that his practice rests on two of the three pillars. However, the third one is absent and has been replaced by a bizarre imitation. To pretend that external evidence can be substituted by something else is erroneous and introduces double standards which are not acceptable – not because this would be against some bloodless principles of nit-picking academics, but because it would not be in the best interest of the patient. And, after all, the primary concern of EBM has to be the patient.

Chiropractors have become (in)famous for making claims which  contradict the known facts. One claim that we find with unfailing regularity is that “regular chiropractic treatments will improve your quality of life“. There are uncounted websites advertising this notion, and most books on the subject promote it as well, some are even entirely dedicated to the theme. Here is a quote from a typical quote from one site chosen at random: “Quality of life chiropractic care is the pinnacle of chiropractic care within the chiropractic paradigm.  It does not solely rely on pain or postural findings, but rather on how a persons life can be positively influenced through regular adjustments… A series of regular adjustments is programmed and continual advice on life improvement is given.  It is designed as a long term approach and gains its strength from the regularity of its delivery.”

Given the ubiquitous nature of such claims, and given the fact that many chiropractic clients have back problems which reduce their quality of life, and given that back pain is just about the only condition for which chiropractors might have something to offer, it seems relevant to ask the following question: what is the evidence that chiropractic interventions affect the quality of life of back pain sufferers?

Some time ago, an Italian randomised clinical trial compared chiropractic spinal manipulations with sham-manipulations in patients affected by back pain and sciatica. Its results were disappointing and showed “no significant differences in quality of life and psychosocial scores.” But this is just one (potentially cherry-picked) study, I hear my chiropractic friends object. What we quite clearly need, is someone who takes the trouble to evaluate the totality of the available evidence.

Recently, Australian researchers published a review which did just that. Its authors conducted thorough literature searches to find all relevant studies on the subject. Of the 1,165 articles they located, 12 investigations of varying quality were retained, representing 6 studies, 4 randomised clinical trial and two observational studies. There was a high degree of inconsistency and lack of standardisation in measurement instruments and outcome measures. Three studies reported reduced use of additional treatments as a positive outcome; two studies reported a positive effect of chiropractic interventions on pain, and two studies reported a positive effect on disability. The 6 studies reviewed concentrated on the impact of chiropractic care on physical health and disability, rather than the wider holistic view which was the focus of the review. On the basis of this evidence, the authors conclude that “it is difficult… to defend any conclusion about the impact of chiropractic intervention on the quality of life, lifestyle, health and economic impact on chiropractic patients presenting with back pain.”

So….

What should we make of all this? I don’t know about you, but I fear the notion that chiropractic improves the quality of life of back pain patients is just another of these many bogus assumptions which chiropractors across the globe seem to promote, advertise and make a living from.

Reiki is a form of  healing which rests on the assumption that some form “energy” determines our health. In this context, I tend to put energy in inverted commas because it is not the energy a physicist might have in mind. It is a much more mystical entity, a form of vitality that is supposed to be essential for life and keep us going. Nobody has been able to define or quantify this “energy”, it defies scientific measurement and is biologically implausible. These circumstances render Reiki one of the least plausible therapies in the tool kit of alternative medicine.

Reiki-healers (they prefer to be called “masters”) would channel “energy” into his or her patient which, in turn, is thought to stimulate the healing process of whatever condition is being treated. In the eyes of those who believe in this sort of thing, Reiki is therefore a true panacea: it can heal everything.

The clinical evidence for or against Reiki is fairly clear – as one would expect after realising how ‘far out’ its underlying concepts are. Numerous studies are available, but most are of very poor quality. Their results tend to suggest that patients experience benefit after having Reiki but they rarely exclude the possibility that this is due to placebo or other non-specific effects. Those that are rigorous show quite clearly that Reiki is a placebo. Our own review therefore concluded that “the evidence is insufficient to suggest that Reiki is an effective treatment for any condition… the value of Reiki remains unproven.”

Since the publication of our article, a number of new investigations have become available. In a brand-new study, for instance, the researchers wanted to explore a Reiki therapy-training program for the care-givers of paediatric patients. A series of Reiki training classes were offered by a Reiki-master. At the completion of the program, interviews were conducted to elicit participant’s feedback regarding its effectiveness.

Seventeen families agreed to participate and 65% of them attended three Reiki training sessions. They reported that Reiki had benefited their child by improving their comfort (76%), providing relaxation (88%) and pain relief (41%). All caregivers thought that becoming an active participant in their child’s care was a major gain. The authors of this investigation conclude that “a hospital-based Reiki training program for caregivers of hospitalized pediatric patients is feasible and can positively impact patients and their families. More rigorous research regarding the benefits of Reiki in the pediatric population is needed.

Trials like this one abound in the parallel world of “energy” medicine. In my view, such investigations do untold damage: they convince uncritical thinkers that “energy” healing is a rational and effective approach – so much so that even the military is beginning to use it.

The flaws in trials as the one above are too obvious to mention. Like most studies in this area, this new investigation proves nothing except the fact that poor quality research will mislead those who believe in its findings.

Some might say, so what? If a patient experiences benefit from a bogus yet harmless therapy, why not? I would strongly disagree with this increasingly popular view. Reiki and similarly bizarre forms of “energy” healing are well capable of causing harm.

Some fanatics might use these placebo-treatments as a true alternative to effective therapies. This would mean that the condition at hand remains untreated which, in a worst case scenario, might even lead to the death of patients. More important, in my view, is an entirely different risk: making people believe in mystic “energies” undermines rationality in a much more general sense. If this happens, the harm to society would be incalculable and extends far beyond health care.

Five years ago to the day, Simon Singh and I published an article in The Daily Mail to promote our book TRICK OR TREATMENT… which was then about to be launched. We recently learnt that our short article prompted a “confidential” message by the BRITISH CHIROPRACTIC ASSOCIATION to all its members. “Confidential” needs to be put in inverted commas because it is readily available on the Internet. I find it fascinating and of sufficient public interest to reproduce it here in full. I have not altered a thing in the following text, except putting it in italics and putting the section where the BCA quote our text in bold for clarity.

CONFIDENTIAL FOR BCA MEMBERS ONLY

Information for BCA members regarding an article in the Daily Mail – April 8th 2008

A double page spread appeared in the edition of the Daily Mail April 8th 2008 on page 46 and 47 and titled ‘Alternative Medicine The Verdict’.

The article was written by Simon Singh and Edzard Ernst and is a publicity prelude to a book they have written called ‘Trick or Treatment? Alternative Medicine on Trial’, which will be published later this month.

The article covers Alexander Technique, Aromatherapy, Flower Remedy, Chiropractic, Hypnotherapy, Magnet Therapy and Osteopathy.

The coverage of Chiropractic follows a familiar pattern for E Ernst. The treatment is oversimplified in explanation, with a heavy emphasis on words like thrust, strong and aggressive. There is tacit acknowledgement that chiropractic works for back pain, but then there is a long section about caution regarding neck manipulation. The article concludes by advising people not to have their neck manipulated and not to allow children to be treated.

CHIROPRACTIC THERAPY

WHAT IS IT? Chiropractors use spinal manipulation to realign the spine to restore mobility. Initial examination often includes X-ray images or MRI scans.

Spinal manipulation can be a fairly aggressive technique, which pushes the spinal joint slightly beyond what it is ordinarily capable of achieving, using a technique called high-velocity, low-amplitude thrust – exerting a relatively strong force in order to move the joint at speed, but the extent of the motion needs to be limited to prevent damage to the joint and its surrounding structures.

Although spinal manipulation is often associated with a cracking sound, this is not a result of the bones crunching or a sign that bones are being put back; the noise is caused by the release and popping of gas bubbles, generated when the fluid in the joint space is put under severe stress.

Some chiropractors claim to treat everything from digestive disorders to ear infections, others will treat only back problems.

DOES IT WORK? There is no evidence to suggest that spinal manipulation is effective for anything but back pain and even then conventional approaches (such as regular exercise and ibuprofen) are just as likely to be effective and are cheaper.

Neck manipulation has been linked to neurological complications such as strokes – in 1998, a 20-year-old Canadian woman died after neck manipulation caused a blood clot which led to stroke. We would strongly recommend physiotherapy exercises and osteopathy ahead of chiropractic therapy because they are at least effective and much safer.

If you do decide to visit a chiropractor despite our concerns and warnings, we very strongly recommend you confirm your chiropractor won’t manipulate your neck. The dangers of chiropractic therapy to children are particularly worrying because a chiropractor would be manipulating an immature spine.

Daily Mail 2008 April 8th.

As we are aware that patients or potential patients of our members will be confronted with questions regarding this article, we have put together some comment and Q&As to assist you.

• Please consider this information as strictly confidential and for your use only.

• Only use this if a patient asks about these specific issues; there is nothing to be gained from releasing any information not asked for.

• Do not duplicate these patient notes and hand out direct to the patient or the media; these are designed for you to use when in direct conversation with a patient.

The BCA will be very carefully considering any questions or approaches we may receive from the press and will respond to them using specially briefed spokespeople. We would strongly advise our members not to speak directly to the press on any of the issues raised as a result of this coverage.

Please note that In the event of you receiving queries from the media, please refer these direct to BCA (0118 950 5950 – Anne Barlow or Sue Wakefield) or Publicasity (0207 632 2400 – Julie Doyle or Sara Bailey).

The following points should assist you in answering questions that patients may ask with regard to the safety and effectiveness of chiropractic care. Potential questions are detailed along with the desired ‘BCA response’:

“The Daily Mail article seems to suggest chiropractic treatment is not that effective”

Nothing could be further from the truth. The authors have had to concede that chiropractic treatment works for back pain as there is overwhelming evidence to support this. The authors also contest that pain killers and exercises can do the job just as well. What they fail to mention is that research has shown that this might be the case for some patients, but the amount of time it may take to recover is a lot longer and the chance of re-occurrence of the problem is higher. This means that chiropractic treatment works, gets results more quickly and helps prevent re-occurrence of the problem. Chiropractic is the third largest healthcare profession in the world and in the UK is recognised and regulated by the UK Government.

“The treatment is described as aggressive, can you explain?”

It is important to say that the authors of the article clearly have no direct experience of chiropractic treatment, nor have they bothered to properly research the training and techniques. Chiropractic treatment can take many forms, depending on the nature of the problem, the particular patient’s age and medical history and other factors. The training chiropractors receive is overseen by the government appointed regulator and the content of training is absolutely designed to ensure that an individual chiropractor understands exactly which treatment types are required in each individual patient scenario. Gentle technique, massage and exercise are just some of the techniques available in the chiropractor’s ‘toolkit’. It is a gross generalisation and a demonstration of lack of knowledge of chiropractic to characterise it the way it appeared in the article.

“The article talked about ‘claims’ of success with other problems”

There is a large and undeniable body of evidence regarding the effectiveness of chiropractic treatment for musculoskeletal problems such as back pain. There is also growing evidence that chiropractic treatment can help many patients with other problems; persistent headaches for example. There is also anecdotal evidence and positive patient experience to show that other kinds of problems have been helped by chiropractic treatment. For many of these kinds of problems, the formal research is just beginning and a chiropractor would never propose their treatment as a substitute for other, ongoing treatments.

“Am I at risk of having a stroke if I have a chiropractic treatment?”

What is important to understand is that any association between neck manipulation and stroke is extremely rare. Chiropractic is a very safe form of treatment.

Another important point to understand is that the treatments employed by chiropractors are statistically safer than many other conservative treatment options (such as ibuprofen and other pain killers with side effects such as gastric bleeding) for mechanical low back or neck pain conditions.

A research study in the UK, published just last year studied the neck manipulations received by nearly 20,000 chiropractic patients. NO SERIOUS ADVERSE SIDE EFFECTS WERE IDENTIFIED AT ALL. In another piece of research, published in February this year, stroke was found to be a very rare event and the risk associated with a visit to a chiropractor appeared to be no different from the risk of a stroke following a visit to a GP.

Other recent research shows that such an association with stroke may occur once in every 5.85 million adjustments.

To put this in context, a ‘significant risk’ for any therapeutic intervention (such as pain medication) is defined as 1 in 10,000.

Additional info: Stroke is a natural occurring phenomenon, and evidence dictates that a number of key risk factors increase the likelihood of an individual suffering a stroke. Smoking, high blood pressure, high cholesterol and family medical histories can all contribute; rarely does a stroke occur in isolation from these factors. Also, stroke symptoms can be similar to that of upper neck pains, stiffness or headaches, conditions for which patients may seek chiropractic treatment. BCA chiropractors are trained to recognise and diagnose these symptoms and advise appropriate mainstream medical care.

“Can you tell if I am at risk from stroke?”

As a BCA chiropractor I am trained to identify risk factors and would not proceed with treatment if there was any doubt as to the patient’s suitability. Potential risks may come to light during the taking of a case history, which may include: smoking, high cholesterol, contraceptive pill, Blood clotting problems/blood thinning meds, heart problems, trauma to the head etc and on physical examination e.g. high blood pressure, severe osteoarthritis of the neck, history of rheumatoid arthritis

“Do you ever tell patients if they are at risk?”

Yes, I would always discuss risks with patients and treatment will not proceed without informed consent.

“Is it safe for my child to be treated by a chiropractor”

It is a shame that the article so generalises the treatment provided by a chiropractor, that it makes such outrageous claims. My training in anatomy, physiology and diagnosis means that I absolutely understand the demands and needs of spines from the newborn baby to the very elderly patient. The techniques and treatments I might use on a 25 year old are not the same as those I would employ on a 5 year old. I see a lot of children as patients at this clinic and am able to offer help with a variety of problems with the back, joints and muscles. I examine every patient very thoroughly, understand their medical history and discuss my findings with them and their parents before undertaking any treatment.

– Chiropractic is a mature profession and numerous studies clearly demonstrate that chiropractic treatment, including manipulative and spinal adjustment, is both safe and effective.

– Thousands of patients are treated by me and my fellow chiropractors every day in the UK. Chiropractic is a healthcare profession that is growing purely because our patients see the results and GPs refer patients to us because they know we get results!

This article is to promote a book and a controversial one at that. Certainly, in the case of the comments about chiropractic, there is much evidence and research that has formed part of guidelines developed by the Royal Society of General Practitioners, NICE and other NHS/Government agencies, has been conveniently ignored. The statements about chiropractic treatment and technique demonstrate that there has clearly been no research into the actual education that chiropractors in the UK receive – in my case a four year full-time degree course that meets stringent educational standards set down by the government appointed regulator.

Shortly after the article in The Daily Mail, our book was published and turned out to be much appreciated by critical thinkers across the globe — not, however, by chiropractors.

At the time, I did, of course, not know about the above “strictly confidential” message to BCA members, yet I strongly suspected that chiropractors would do everything in their power to dispute our central argument, namely that most of the therapeutic claims by chiropractors were not supported by sufficient evidence. I also knew that our evidence for it was rock solid; after all, I had researched the evidence for or against chiropractic in full depth and minute detail and published dozens of articles on the subject in the medical literature.

When, one and a half weeks after our piece in the Mail, Simon published his now famous Guardian comment stating that the BCA “happily promote bogus treatments”, he was sued for libel by the BCA. I think the above “strictly confidential” message already reveals the BCA’s determination and their conviction to be on firm ground. As it turned out, they were wrong. Not only did they lose their libel suit, but they also dragged chiropractic into a deep crisis.

The “strictly confidential” message is intriguing in several more ways – I will leave it to my readers to pick out some of the many gems hidden in this text. Personally, I find the most remarkable aspect that the BCA seems to attempt to silence its own members regarding the controversy about the value of their treatments. Instead they proscribe answers (should I say doctrines?) of highly debatable accuracy for them, almost as though chiropractors were unable to speak for themselves. To me, this smells of cult-like behaviour, and is by no means indicative of a mature profession – despite their affirmations to the contrary.

Reflexology is one of the most popular of all alternative therapies. Anyone who has ever had a session knows why: it is a strangely pleasant and oddly agreeable experience. Reflexologists massage your feet which can be mildly painful but usually is quite relaxing. They look for and subsequently focus on areas of tenderness believing they correspond to specific organs or whole organ systems. Even though few reflexologists would admit to it, they tend to make vague and unreliable diagnoses: if they feel something unusual at a certain point of the sole of your foot, they assume that a certain inner organ is in trouble. Reflexologists even have maps where the sole of a foot is depicted showing which area corresponds to which organ.

The treatment might be enjoyable but the assumptions that underpin it are nonsensical for at least two reasons: firstly, there are no nerve or other connections between a specific area on the sole of a foot and a certain organ. Secondly, the maps which reflexologists employ differ and fail to agree which area corresponds to which organ. Thus there are inconsistencies within the realm of reflexology and there are inconsistencies in relation to the known facts regarding physiology, anatomy etc.

Proponents of reflexology are quite undisturbed by these problems and seem to believe that not their assumptions but science must be wrong. After all, reflexology does work! That is to say that patients perceive benefit from it, pay out of their own pocket for the experience and tend to come back for more.

Several years ago, we asked 8 UK professional organisations of reflexology which conditions they thought could be treated effectively with reflexology. We gave them a list of 25 conditions to chose from, many of which were serious, e.g. cancer and AIDS. Collectively, the organisations felt that 22 of these illnesses would respond to reflexology.

But this is opinion, not evidence! What do the trial data tell us? Is reflexology more than a placebo?

As with many other areas of alternative medicine, controlled clinical trials are scarce; but this is not to say that none at all are available. Our own trial of reflexology for menopausal symptoms failed to show that this therapy has any effects beyond placebo. More recently, we published a systematic review to evaluate all of the 23 studies that had been published at that stage. They related to a wide range of medical conditions and their methodological quality was often poor. Nine high quality randomised clinical trials (RCTs) generated negative findings. Eight RCTs suggested that reflexology is effective for the following conditions: diabetes, premenstrual syndrome, cancer patients, multiple sclerosis, symptomatic idiopathic detrusor over-activity and dementia. These studies, however, were wide open to bias. Therefore, our conclusions had to be cautious: the best clinical evidence does not demonstrate convincingly reflexology to be an effective treatment for any medical condition.

For you and me, this simply means that there is currently no good evidence to suggest that reflexology works. But the story does not end here. There will be more studies and enthusiasts are most likely to concede that our conclusions were incorrect. In fact, a further trial has just become available.

This new single-blind, randomized and placebo controlled study included 20 moderately to severely affected multiple sclerosis patients. Each participant received for 8 weeks, 1 hour per week of either reflexology or sham reflexology. The primary outcome measure was the Multiple Sclerosis Impact Scale at baseline, 8 weeks and 16 weeks. The results revealed improvements in both groups but no statistically significant differences between the two groups at either 8 or 16 weeks. The conclusions of the investigators were clear: The results do not support the use of reflexology for symptom relief in a more disabled multiple sclerosis population and are strongly suggestive of a placebo response.

There is, of course, nothing wrong with a relaxing foot-massage; it is agreeable, no doubt, and if someone wants to pay for the luxury, why not? By contrast, there is a lot wrong with reflexology, I think. A foot-massage is not administered under the pretence of generating any specific therapeutic effects. Reflexologists, however, claim they can exert highly specific effects on inner organs, influence the natural history of a wide range of diseases, and provide reliable diagnoses. They thus mislead their clients. This is not just wrong, it also has the potential to do serious harm. I believe it is time to end this nonsense.

Believe it or not, but my decision – all those years ago – to study medicine was to a significant degree influenced by a somewhat naive desire to, one day, be able to save lives. In my experience, most medical students are motivated by this wish – “to save lives” in this context stands not just for the dramatic act of administering a life-saving treatment to a moribund patient but it is meant as a synonym for helping patients in a much more general sense.

I am not sure whether, as a young clinician, I ever did manage to save many lives. Later, I had a career-change and became a researcher. The general view about researchers seems to be that they are detached from real life, sit in ivory towers and write clever papers which hardly anyone understands and few people will ever read. Researchers therefore cannot save lives, can they?

So, what happened to those laudable ambitions of the young Dr Ernst? Why did I decide to go into research, and why alternative medicine; why did I not conduct research in more the promotional way of so many of my colleagues (my life would have been so much more hassle-free, and I even might have a knighthood by now); why did I feel the need to insist on rigorous assessments and critical thinking, often at high cost? For my many detractors, the answers to these questions seem to be more than obvious: I was corrupted by BIG PHARMA, I have an axe to grind against all things alternative, I have an insatiable desire to be in the lime-light, I defend my profession against the concurrence from alternative practitioners etc. However, for me, the issues are a little less obvious (today, I will, for the first time, disclose the bribe I received from BIG PHARMA for criticising alternative medicine: the precise sum was zero £ and the same amount again in $).

As I am retiring from academic life and doing less original research, I do have the time and the inclination to brood over such questions. What precisely motivated my research agenda in alternative medicine, and why did I remain unimpressed by the number of powerful enemies I made pursuing it?

If I am honest – and I know this will sound strange to many, particularly to those who are convinced that I merely rejoice in being alarmist – I am still inspired by this hope to save lives. Sure, the youthful naivety of the early days has all but disappeared, yet the core motivation has remained unchanged.

But how can research into alternative medicine ever save a single life?

Since about 20 years, I am regularly pointing out that the most important research questions in my field relate to the risks of alternative medicine. I have continually published articles about these issues in the medical literature and, more recently, I have also made a conscious effort to step out of the ivory towers of academia and started writing for a much wider lay-audience (hence also this blog). Important landmarks on this journey include:

– pointing out that some forms of alternative medicine can cause serious complications, including deaths,

– disclosing that alternative diagnostic methods are unreliable and can cause serious problems,

– demonstrating that much of the advice given by alternative practitioners can cause serious harm to the patients who follow it,

– that the advice provided in books or on the Internet can be equally dangerous,

– and that even the most innocent yet ineffective therapy becomes life-threatening, once it is used to replace effective treatments for serious conditions.

Alternative medicine is cleverly, heavily and incessantly promoted as being natural and hence harmless. Several of my previous posts and the ensuing discussions on this blog strongly suggest that some chiropractors deny that their neck manipulations can cause a stroke. Similarly, some homeopaths are convinced that they can do no harm; some acupuncturists insist that their needles are entirely safe; some herbalists think that their medicines are risk-free, etc. All of them tend to agree that the risks are non-existent or so small that they are dwarfed by those of conventional medicine, thus ignoring that the potential risks of any treatment must be seen in relation to their proven benefit.

For 20 years, I have tried my best to dispel these dangerous myths and fallacies. In doing so, I had to fight many tough battles  (sometimes even with the people who should have protected me, e.g. my peers at Exeter university), and I have the scars to prove it. If, however, I did save just one life by conducting my research into the risks of alternative medicine and by writing about it, the effort was well worth it.

Fairly early on during my time at Exeter, I had felt that it would be relevant, interesting and important to familiarise general practitioners with alternative medicine. At the time, we decided that we would start to run regular courses specifically for these health care professionals. Back in the mid 1990s, this was a remarkable thing to do, so much so that we even published our experience after the first such event. Recently I came across the article that resulted from this endeavour; here is an except from the abstract:

The delegates started with a positive but questioning attitude toward complementary medicine (CM) and acknowledged that they gained useful information, leading to increased confidence in discussing CM with patients. The course to a large extent met their needs and expectations. Benefits and draw-backs of integrating CM within general practice were explored. The main advantage of CM, apart from the potential intrinsic value of the techniques themselves, was identified as the time to establish a good therapeutic relationship with the patient. The particular concerns about CM that were expressed by the doctors included poor dialogue with CM practitioners, doubts about competence, and lack of readily identifiable and recognized qualifications. The risk of holding out unrealistic hope of cure was their greatest concern, however, especially if patients were thereby denied an effective orthodox treatment.

What strikes me as particularly remarkable is the fact that, even then, so many doubts were voiced by our GPs about alternative practitioners, their therapeutic claims and their doubtful medical competence. It was then that it occured to me for the first time that these therapists might systematically misinform their patients. This suspicion was strengthened on numerous occasions in the years to come; but it was not until much later that we decided to look into this subject (which is rather difficult to research) more systematically. What we found shocked us. Here are the conclusions of some of our investigations:

The most popular websites on complementary and alternative medicine for cancer offer information of extremely variable quality. Many endorse unproven therapies and some are outright dangerous. The link to the article is here.

Some complementary and alternative medicine (CAM) providers have a negative attitude towards immunisation and means of changing this should be considered. The link is here.

Advice about herbal medicine is readily available over the Internet. The advice offered is misleading at best and dangerous at worst. Potential Internet users should be made aware of these problems and ways of minimizing the risk should be found. The link is here.

The majority of chiropractors and their associations in the English-speaking world seem to make therapeutic claims that are not supported by sound evidence, whilst only 28% of chiropractor websites promote lower back pain, which is supported by some evidence. We suggest the ubiquity of the unsubstantiated claims constitutes an ethical and public health issue. The link is here.

In another study, we found that advice given by alternative practitioners to diabetic patients had the potential to kill them. A similarly scary conclusion emerged when we evaluated the advice chiropractors provide to asthma patients. Other research found that anthroposophic doctors often advise against measles vaccinations and are thus causing measles outbreaks.

The totality of this evidence, I believe, begs the question: DO ALTERNATIVE PRACTITIONERS SYSTEMATICALLY MISINFORM THEIR PATIENTS? I look forward to a lively discussion of it.

The developed world is in the middle of a major obesity epidemic. It is predicted to cause millions of premature deaths and billions of dollars, money that would be badly needed elsewhere. The well-known method of eating less and moving more is most efficacious but sadly not very effective, that is to say people do not easily adopt and adhere to it. This is why many experts are searching for a treatment that works and is acceptable to all or at least most patients.

Entrepreneurs of alternative medicine have long jumped on this band waggon. They have learnt that the regulations are lax or non-existent, that consumers are keen to believe anything they tell them and that the opportunities to make a fast buck are thus enormous. Today, they are offering an endless array of treatments which are cleverly marketed, for instance via the Internet.

Since many years, my research team are involved in a programme of assessing the alternative slimming aids mostly through systematic reviews and occasionally also through conducting our own clinical trials. Our published analyses include the following treatments:

Phaseolus vulgaris

Supplements containing conjugated linoleic acid

Green tea

Garcinia extracts

Calcium supplements

Chromium picolinate

Guar gum

Chitosan

Acupuncture

There are, of course, many more but, for most, no evidence exist at all. The treatments listed above have all been submitted to clinical trials. The results show invariably that the outcomes were not convincingly positive: either there were too few data, or there were too many flaws in the studies, or the weight reduction achieved was too small to be clinically relevant.

Our latest systematic review is a good example; its aim was to evaluate the evidence from randomized controlled trials (RCTs) involving the use of the African Bush Mango, Irvingia gabonensis, for body weight reduction in obese and overweight individuals. Three RCTs were identified, and all had major methodological flaws. All RCTs reported statistically significant reductions in body weight and waist circumference favoring I. gabonensis over placebo. They also suggested positive effects of I. gabonensis on blood lipids. Adverse events included headache and insomnia. Despite these apparently positive findings, our conclusions had to be cautious: “Due to the paucity and poor reporting quality of the RCTs, the effect of I. gabonensis on body weight and related parameters are unproven. Therefore, I. gabonensis cannot be recommended as a weight loss aid. Future research in this area should be more rigorous and better reported.”

People who want to loose weight are often extremely desperate and ready to try anything. They are thus easy victims of the irresponsible promises that are being made on the Internet and elsewhere. Despite the overwhelmingly evidence to the contrary, consumers are led to believe that alternative slimming aids are effective. What is more, they are also misled to assume they are risks-free. This latter assumption is false too: apart from the harm done to the patient’s bank account, many alternative slimming aids are associated with side-effects which, in some cases, are  serious and can even include death.

The conclusion from all this is short and simple: alternative slimming aids are bogus.

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