MD, PhD, FMedSci, FRSB, FRCP, FRCPEd

bogus claims

According to the UK General Osteopathic Council, osteopathy is a system of diagnosis and treatment for a wide range of medical conditions.  It works with the structure and function of the body, and is based on the principle that the well-being of an individual depends on the skeleton, muscles, ligaments and connective tissues functioning smoothly together.

To an osteopath, for your body to work well, its structure must also work well.  So osteopaths work to restore your body to a state of balance, where possible without the use of drugs or surgery.  Osteopaths use touch, physical manipulation, stretching and massage to increase the mobility of joints, to relieve muscle tension, to enhance the blood and nerve supply to tissues, and to help your body’s own healing mechanisms.  They may also provide advice on posture and exercise to aid recovery, promote health and prevent symptoms recurring.

In case this sounds a bit vague to you, and in case you wonder what this “wide range of conditions” might be, rest assured, you are not alone. So let’s try to be a little more concrete and clear up some of the confusion around this profession. There are two very different types of osteopaths: US osteopaths are virtually identical with conventionally trained physicians; their qualification is equivalent to those of medical practitioners and they can, for instance, specialise to become GPs or neurologists or surgeons etc. Elsewhere, osteopaths are non-medically qualified alternative practitioners. In the UK, they are regulated by statute, in other counties not. And as to the “wide range of conditions”, I am not aware of any disease or symptom for which the evidence is convincing.

Osteopaths most commonly treat patients suffering from Chronic Non-Specific Low Back Pain (CNSLBP) using a set of non-drug interventions, particularly manual therapies such as spinal mobilisation and manipulation. The question is how well are these techniques supported by reliable evidence. To answer it, we must not cherry-pick our evidence but we need to consider the totality of the reliable studies; in other words, we need an up-to-date systematic review. Such an assessment of clinical research into osteopathic intervention for CNSLBP was recently published by Australian experts.

A thorough search of the literature in multiple electronic databases was undertaken,  and all articles were included that reported clinical trials; had adult participants; tested the effectiveness and/or efficacy of osteopathic manual therapies applied by osteopaths, and had a study condition of CNSLBP. The quality of the trials was assessed using the Cochrane criteria. Initial searches located 809 papers, 772 of which were excluded on the basis of abstract alone. The remaining 37 papers were subjected to a detailed analysis of the full text, which resulted in 35 further articles being excluded. There were thus only two studies assessing the effectiveness of manual therapies applied by osteopaths in adult patients with CNSLBP. The results of one trial suggested  that the osteopathic intervention was similar in effect to a sham intervention, and the other implies equivalence of effect between osteopathic intervention, exercise and physiotherapy.

I guess, this comes as a bit of a surprise to many consumers who have been told over and over again by osteopaths and their supporters that the evidence is sound. Personally, I am not at all surprised because, two years ago, we published a similar review, albeit with a wider spectrum of conditions, namely any type of musculoskeletal pain. We managed to include a total of 16 RCTs. Five of them suggested that osteopathy leads to a significantly stronger reduction of musculoskeletal pain than a range of control interventions. However, 11 RCTs indicated that osteopathy, compared to controls, generates no change in musculoskeletal pain. At the time, we felt that these data fail to produce compelling evidence for the effectiveness of osteopathy as a treatment of musculoskeletal pain.

This lack of convincing evidence is in sharp contrast to the image of osteopaths as back pain specialists. The UK General Osteopathic council, for instance, sates that Osteopaths’ patients include the young, older people, manual workers, office professionals, pregnant women, children and sports people. Patients seek treatment for a wide variety of conditions, including back pain…In addition, thousands of websites try to convince the consumer that osteopathy is a well-proven therapy for chronic low back pain – not to mention the many other conditions for which the evidence is even less sound.

As so often in alternative medicine, these claims seem to be based more on wishful thinking than on reliable evidence. And as so often, the victims of bogus claims are the consumers who are being misled into making wrong therapeutic decisions, wasting money, and delaying recovery from illness.

Ignaz von Peczely (1826-1911), a Hungarian physician, got the idea for iridology (or iris-diagnosis) more than a century ago, after seeing streaks in the iris of a man he was treating for a broken leg, and similar phenomena the iris of an owl whose leg von Peczely had broken many years before. He subsequently became convinced that his method was able to distinguish between healthy organs and those that are overactive, inflamed, or distressed. Iridology became internationally known when US chiropractors began adopting this method in their clinical practice. In the United States, most insurance programs do not cover iridology but, in some European countries, they often do. In Germany, for instance, 80% of the Heilpraktiker (non-medically qualified health practitioners) practice iridology.

Iridologists claim to be able to diagnose the health status of an individual, medical conditions or predispositions to disease through abnormalities of pigmentation in the iris. The popularity of iridology renders it necessary to ask whether this method is valid.

The aim of my systematically review from 1999 was to critically evaluate all available, reliable tests of iridology as a diagnostic tool. Four case control studies were included; these are investigations where iridologists are asked to tell by looking at the iris of individuals whether that person does or does not have a certain condition. The majority of these studies suggested that iridology is not a valid diagnostic method. Back then, I concluded that “the validity of iridology as a diagnostic tool is not supported by scientific evaluations. Patients and therapists should be discouraged from using this method.”

Since the publication of my article, several further studies have emerged:

One German team conducted a study investigating the applicability of iridology as a screening method for colorectal cancer. Digital color slides were obtained from both eyes of 29 patients with histologically diagnosed colorectal cancer and from 29 age- and gender-matched healthy control subjects. The slides were presented in random order to acknowledged iridologists without knowledge of the number of patients in the two categories. The iridologists correctly detected 51.7% and 53.4%, respectively, of the patients’ slides; therefore, the likelihood was statistically no better than chance. Sensitivity was, respectively, 58.6% and 55.2%, and specificity was 44.8% and 51.7%. The authors’ conclusion was blunt: “Iridology had no validity as a diagnostic tool for detecting colorectal cancer in this study.”

A study from South Africa aimed to determine the efficacy of iridology in the identification of moderate to profound sensorineural hearing loss in adolescents. A controlled trial was conducted with an iridologist, blind to the actual hearing status of participants, analysing the irises of participants with and without hearing loss. Fifty hearing impaired and fifty normal hearing subjects, between the ages of 15 and 19 years, controlled for gender, participated in the study. An experienced iridologist analysed the randomised set of participants’ irises. A 70% correct identification of hearing status was obtained with a false negative rate of 41% compared to a 19% false positive rate. The respective sensitivity and specificity rates therefore were 59% and 81%. The authors of this investigation concluded that “iridological analysis of hearing status indicated a statistically significant relationship to actual hearing status (P < 0.05). Although statistically significant sensitivity and specificity rates for identifying hearing loss by iridology were not comparable to those of traditional audiological screening procedures.”

A further German study investigated the value of iridology as a diagnostic tool in detecting some common cancers. One hundred ten subjects were enrolled; 68 subjects had histologically proven cancers of the breast, ovary, uterus, prostate, or colorectum, and 42 were cancer-free controls. All subjects were examined by an experienced practitioner of iridology, who was unaware of their medical details. He was allowed to suggest up to five diagnoses for each subject and his results were then compared with each subject’s medical diagnosis to determine the accuracy of iridology in detecting malignancy. Iridology identified the correct diagnosis in only 3 cases (sensitivity, 0.04). The authors concluded that “iridology was of no value in diagnosing the cancers investigated in this study.”

Based on these results it is impossible, I think, to claim that iridology is a valid or useful diagnostic tool. As there is no anatomical or physiological basis for its assumptions, iridology is not biologically plausible. Furthermore, the available clinical evidence does not support its validity as a diagnostic tool. In other words, iridology is bogus. This statement is in sharp contract to the information consumers receive about the method on uncounted websites, books, articles, etc. One website picked at random provides the following information:

The iris reveals changing conditions of every part and organ of the body. Every organ and part of the body is represented in the iris in a well defined area. In addition, through various marks, signs, and discoloration in the iris, nature reveals inherited weaknesses and strengths.

By means of this art / science, an iridologist (one who studies the coloration and fiber structure of the eye) can tell an individual his/her inherited and acquired tendencies towards health and disease, his current condition in general, and the state of every organ in particular.

Iridology cannot detect a specific disease, but, can tell an individual if they have over or under activity in specific areas of the body. For example, an under-active pancreas might indicate a diabetic condition.

Another source claims:

The underlying platform of iridology is that that eyes act as a ‘window’ to a person’s health & well being. This ‘window’ enables the practitioner to see whether areas or organs within the body are healthy, inflamed or ‘over active’. It also enables them to assess a person’s past/ possible future health problems & consider if the patient has a susceptibility to certain diseases. It is important to understand that iridology is simply a method of diagnosis & analysis.

You may well think that none of this really matters. Who cares whether iridology is bogus or not! I would argue that it does matter. Bogus methods cost money that could be better spent elsewhere. More importantly, false positive and false negative diagnoses generated by bogus diagnostic methods can put lives at risk.

But there is a more general and perhaps more crucial point here: alternative medicine is an area where people far too easily get away with ignoring the published evidence and scientific consensus. In the last two decades, I have seen many alternative modalities getting scientifically dis-proven; not in a single such instance can I remember that the corresponding alternative practitioners and their professional organisations took any notice of this fact, and not once did I notice that their practice had changed.

If research is  systematically ignored, it becomes a useless appendix. More importantly, progress is then stifled to the detriment of all our best interests.

A stroke is a condition where brain cells get irreversibly damaged either by a haemorrhage in the brain or by a blood clot cutting off oxygen supply. This process leaves most patients with neurological deficits such as difficulties in moving, speaking, concentrating etc. As other parts of the brain learn to take over, these problems can partly or completely resolve themselves over time, but many patients are left with permanent handicaps. Stroke-rehabilitation can minimise these problems, and there is a long-standing debate as to which measures are most effective. Acupuncture has been discussed as a method to improve the results of stroke-rehabilitation, but the evidence is hotly disputed. This is why a new study in this area is an important contribution to our existing knowledge.

The aim of this randomised trial was to test the effectiveness of acupuncture in promoting the recovery of patients with ischaemic stroke and to determine whether the outcomes of combined physiotherapy and acupuncture are superior to those with physiotherapy alone. The Chinese investigators recruited 120 patients who received one of three daily treatments: 1) acupuncture, 2) physiotherapy, 3) physiotherapy combined with acupuncture. Motor function in the limbs was measured with the Fugl-Meyer assessment (FMA); the modified Barthel index (MBI) was used to rate activities of daily living; both of these measures are validated and well-established. All evaluations were performed by assessors blinded to treatment allocation.

At baseline, FMA and MBI scores did not significantly differ among the treatment groups. Compared with baseline, on day 28 of therapy, the mean FMA scores of the physiotherapy, acupuncture, and combined treatment groups had increased by 65.6%, 57.7%, and 67.2%, respectively; on day 56, FMA scores had increased by 88.1%, 64.5%, and 88.6%, respectively. The respective MBI scores in the three groups had increased by 85.2%, 60.4%, and 63.4% at day 28 and by 108.0%, 71.2%, and 86.2% at day 56, respectively. However, FMA scores did not significantly differ between the three treatment groups on the 28th day. By the day 56, the FMA and MBI scores of the physiotherapy group were 46.1% and 33.2% greater, respectively, than those in the acupuncture group. No significant differences were seen between the combined treatment group and the other groups. The FMA subscores for the upper extremities did not show significant improvements in any group on day 56.

The authors draw the following conclusion: “Acupuncture is less effective for the outcome measures studied than is physiotherapy. Moreover, the therapeutic effect of combining acupuncture with physiotherapy was not superior to that of physiotherapy alone. A larger-scale clinical trial is necessary to confirm these finding.”

Our own study arrived at similarly disappointing conclusions: “Acupuncture is not superior to sham treatment for recovery in activities of daily living and health-related quality of life after stroke, although there may be a limited effect on leg function in more severely affected patients“. Our review of all 10 sham-controlled RCTs in this area is also in line with the results of this new study: “Our meta-analyses of data from rigorous randomized sham-controlled trials did not show a positive effect of acupuncture as a treatment for functional recovery after stroke”

I am quite sure that some acupuncture-enthusiasts will dispute this evidence. They might argue that I am too critical, the trials were not done optimally, that acupuncturists have seen plenty of good results in their clinical practice, that acupuncture is a complex intervention that does not fit into the straight jacket of an RCT, that this or that “prestigious” organisation recommends acupuncture for stroke patients, that it would be wrong not to give acupuncture a try etc. etc. I would counter that the reliable evidence available to date is sufficiently conclusive to stop claiming that acupuncture is effective and thus give false hope to severely suffering, vulnerable patients. Moreover, I would advocate using the sparse available resources to help stroke victims with treatments that demonstrably work.

One of the best-selling supplements in the UK as well as several other countries is evening primrose oil (EPO). It is available via all sorts of outlets (even respectable pharmacies – or is that supposedly respectable?), and is being promoted for a wide range of conditions, including eczema. The NIH website is optimistic about its efficacy: “Evening primrose oil may have modest benefits for eczema.” Our brand-new Cochrane review was aimed at critically assessing the effects of oral EPO or borage oil (BO) on the symptoms of atopic eczema, and it casts considerable doubt on this somewhat uncritical view.

Here is what we did: We searched six databases as well as online trials registers and checked the bibliographies of included studies for further references to relevant trials. We corresponded with trial investigators and pharmaceutical companies to identify unpublished and ongoing trials. We also performed a separate search for adverse effects. All RCTs investigating oral intake of EPO or BO for eczema were included.

Two experts independently applied eligibility criteria, assessed risk of bias, and extracted data. We pooled dichotomous outcomes using risk ratios (RR), and continuous outcomes using the mean difference (MD). Where possible, we pooled study results using random-effects meta-analysis and tested statistical heterogeneity.

And here is what we found: 27 studies with a total of 1596 participants met our inclusion criteria: 19 studies tested EPO, and 8 studies assessed BO. A meta-analysis of results from 7 studies showed that EPO failed to improve global eczema symptoms as reported by participants and doctors. Treatment with BO also failed to improve global eczema symptoms. 67% of the studies had a low risk of bias for random sequence generation; 44%, for allocation concealment; 59%, for blinding; and 37%, for other biases.

Our conclusions were clear: Oral borage oil and evening primrose oil lack effect on eczema; improvement was similar to respective placebos used in trials. Oral BO and EPO are not effective treatments for eczema.

The very wide-spread notion that EPO is effective for eczema and a range of other conditions was originally promoted by the researcher turned entrepreneur, D F Horrobin, who claimed that several human diseases, including eczema, were due to a lack of fatty acid precursors and could thus be effectively treated with EPO. In the 1980s, Horrobin began to sell EPO supplements without having conclusively demonstrated their safety and efficacy; this led to confiscations and felony indictments in the US. As chief executive of Scotia Pharmaceuticals, Horrobin obtained licences for several EPO-preparations which later were withdrawn for lack of efficacy. Charges of mismanagement and fraud led to Horrobin being ousted as CEO by the board of the company. Later, Horrobin published a positive meta-analysis of EPO for eczema where he excluded the negative results of the largest published trial, but included results of 7 of his own unpublished studies. When scientists asked to examine the data, Horrobin’s legal team convinced the journal to refuse the request.

The evidence for EPO is negative not just for eczema. To the best of my knowledge, there is not a single disease or symptom for which it demonstrably works. Our own review of the data concluded ” EPO has not been established as an effective treatment for any condition”

Our new Cochrane review might help to put this long saga to rest. In my view, it is a fascinating tale of a scientist being blinded by creed and ambition. The results of such errors can be dramatic. Horrobin misled all of us: patients, health care professionals, scientists, regulators, decision makers, businessmen. This caused unnecessary expense and set back research efforts in a multitude of areas. I find the tale also fascinating from other perspectives; for instance, it begs the question why so many ‘respectable’ manufacturers and retailers are still allowed to make money on EPO. Is it not time to debunk the EPO-myth and say it as clearly as possible: EPO helps only those who financially profit from misleading the public?

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.

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