conflict of interest
A recent meta-analysis evaluated the efficacy of acupuncture for treatment of irritable bowel syndrome (IBS) and arrived at bizarrely positive conclusions.
The authors state that they searched 4 electronic databases for double-blind, placebo-controlled trials investigating the efficacy of acupuncture in the management of IBS. Studies were screened for inclusion based on randomization, controls, and measurable outcomes reported.
Six RCTs were included in the meta-analysis, and 5 articles were of high quality. The pooled relative risk for clinical improvement with acupuncture was 1.75 (95%CI: 1.24-2.46, P = 0.001). Using two different statistical approaches, the authors confirmed the efficacy of acupuncture for treating IBS and concluded that acupuncture exhibits clinically and statistically significant control of IBS symptoms.
As IBS is a common and often difficult to treat condition, this would be great news! But is it true? We do not need to look far to find the embarrassing mistakes and – dare I say it? – lies on which this result was constructed.
The largest RCT included in this meta-analysis was neither placebo-controlled nor double blind; it was a pragmatic trial with the infamous ‘A+B versus B’ design. Here is the key part of its methods section: 116 patients were offered 10 weekly individualised acupuncture sessions plus usual care, 117 patients continued with usual care alone. Intriguingly, this was the ONLY one of the 6 RCTs with a significantly positive result!
The second largest study (as well as all the other trials) showed that acupuncture was no better than sham treatments. Here is the key quote from this trial: there was no statistically significant difference between acupuncture and sham acupuncture.
So, let me re-write the conclusions of this meta-analysis without spin, lies or hype: These results of this meta-analysis seem to indicate that:
- currently there are several RCTs testing whether acupuncture is an effective therapy for IBS,
- all the RCTs that adequately control for placebo-effects show no effectiveness of acupuncture,
- the only RCT that yields a positive result does not make any attempt to control for placebo-effects,
- this suggests that acupuncture is a placebo,
- it also demonstrates how misleading studies with the infamous ‘A+B versus B’ design can be,
- finally, this meta-analysis seems to be a prime example of scientific misconduct with the aim of creating a positive result out of data which are, in fact, negative.
Recently, I have been invited by the final year pharmacy students of the ‘SWISS FEDERAL INSTITUTE OF TECHNOLOGY ZURICH‘ to discuss alternative medicine with them. The aspect I was keen to debate was the issue of retail-pharmacists selling medicines which are unproven or even disproven. Using the example of homeopathic remedies, I asked them how many might, when working as retail-pharmacists, sell such products. About half of them admitted that they would do this. In real life, this figure is probably closer to 100%, and this discrepancy may well be a reflection of the idealism of the students, still largely untouched by the realities of retail-pharmacy.
In our discussions, we also explored the reasons why retail-pharmacists might offer unproven or disproven medicines like homeopathic remedies to their customers. The ethical codes of pharmacists across the world quite clearly prohibit this – but, during the discussions, we all realised that the moral high ground is not easily defended against the necessity of making a living. So, what are the possible motivations for pharmacists to sell bogus medicines?
One reason would be that they are convinced of their efficacy. Whenever I talk to pharmacists, I do not get the impression that many of them believe in homeopathy. During their training, they are taught the facts about homeopathy which clearly do not support the notion of efficacy. If some pharmacists nevertheless were convinced of the efficacy of homeopathy, they would obviously not be well informed and thus find themselves in conflict with their duty to practice according to the current best evidence. On reflection therefore, strong positive belief can probably be discarded as a prominent reason for pharmacists selling bogus medicines like homeopathic remedies.
Another common argument is the notion that, because patients want such products, pharmacists must offer them. When considering it, the tension between the ethical duties as a health care professional and the commercial pressures of a shop-keeper becomes painfully obvious. For a shop-keeper, it may be perfectly fine to offer all products which might customers want. For a heath care professional, however, this is not necessarily true. The ethical codes of pharmacists make it perfectly clear that the sale of unproven or disproven medicines is not ethical. Therefore, this often cited notion may well be what pharmacists feel, but it does not seem to be a valid excuse for selling bogus medicines.
A variation of this theme is the argument that, if patients were unable to buy homeopathic remedies for self-limiting conditions which do not really require treatment at all, they would only obtain more harmful drugs. The notion here is that it might be better to sell harmless homeopathic placebos in order to avoid the side-effects of real but non-indicated medicines. In my view, this argument does not hold water: if no (drug) treatment is indicated, professionals have a duty to explain this to their patients. In this sector of health care, a smaller evil cannot easily be justified by avoiding a bigger one; on the contrary, we should always thrive for the optimal course of action, and if this means reassurance that no medical treatment is needed, so be it.
An all too obvious reason for selling bogus medicines is the undeniable fact that pharmacists earn money by doing so. There clearly is a conflict of interest here, whether pharmacists want to admit it or not – and mostly they fail to do so or play down this motivation in their decision to sell bogus medicines.
Often I hear from pharmacists working in large chain pharmacies like Boots that they have no influence whatsoever over the range of products on sale. This perception mat well be true. But equally true is the fact that no health care professional can be forced to do things which violate their code of ethics. If Boots insists on selling bogus medicines, it is up to individual pharmacists and their professional organisations to change this situation by protesting against such unethical malpractice. In my view, the argument is therefore not convincing and certainly does not provide an excuse in the long-term.
While discussing with the Swiss pharmacy students, I was made aware of yet another reason for selling bogus medicines in pharmacies. Some pharmacists might feel that stocking such products provides an opportunity for talking to patients and informing them about the evidence related to the remedy they were about to buy. This might dissuade them from purchasing it and could persuade them to get something that is effective instead. In this case, the pharmacist would merely offer the bogus medicine in order to advise customers against employing it. This strategy might well be an ethical way out of the dilemma; however, I doubt that this strategy is common practice with many pharmacists today.
With all this, we should keep in mind that there are many shades of grey between the black and white of the two extreme attitudes towards bogus medicines. There is clearly a difference whether pharmacists actively encourage their customers to buy bogus treatments (in the way it often happens in France, for instance), or whether they merely stock such products and, where possible, offer responsible, evidence-based advise to people who are tempted to buy them.
At the end of the lively but fruitful discussion with the Swiss students I felt optimistic: perhaps the days when pharmacists were the snake-oil salesmen of the modern era are counted?
There is much debate about the usefulness of chiropractic. Specifically, many people doubt that their chiropractic spinal manipulations generate more good than harm, particularly for conditions which are not related to the spine. But do chiropractors treat such conditions frequently and, if yes, what techniques do they employ?
This investigation was aimed at describing the clinical practices of chiropractors in Victoria, Australia. It was a cross-sectional survey of 180 chiropractors in active clinical practice in Victoria who had been randomly selected from the list of 1298 chiropractors registered on Chiropractors Registration Board of Victoria. Twenty-four chiropractors were ineligible, 72 agreed to participate, and 52 completed the study.
Each participating chiropractor documented encounters with up to 100 consecutive patients. For each chiropractor-patient encounter, information collected included patient health profile, patient reasons for encounter, problems and diagnoses, and chiropractic care.
Data were collected on 4464 chiropractor-patient encounters between 11 December 2010 and 28 September 2012. In most (71%) cases, patients were aged 25-64 years; 1% of encounters were with infants. Musculoskeletal reasons for the consultation were described by patients at a rate of 60 per 100 encounters, while maintenance and wellness or check-up reasons were described at a rate of 39 per 100 encounters. Back problems were managed at a rate of 62 per 100 encounters.
The most frequent care provided by the chiropractors was spinal manipulative therapy and massage. The table shows the precise conditions treated
|Problem group||No. (%) of recorded diagnoses* (n = 5985)||Rate per 100 encounters (n = 4417)||95% CI||ICC|
|Back problem||2757 (46.07%)||62.42||(55.24–70.53)||0.312|
|Neck problem||683 (11.41%)||15.46||(11.23–21.30)||0.233|
|Muscle problem||434 (7.25%)||9.83||(6.64–14.55)||0.207|
|Health maintenance or preventive care||254 (4.24%)||5.75||(3.24–10.22)||0.251|
|Back syndrome with radiating pain||215 (3.59%)||4.87||(2.91–8.14)||0.165|
|Musculoskeletal symptom or complaint, or other||219 (3.66%)||4.96||(2.39–10.28)||0.350|
|Sprain or strain of joint||167 (2.79%)||3.78||(2.30–6.22)||0.115|
|Shoulder problem||87 (1.45%)||1.97||(1.37–2.83)||0.022|
|Nerve-related problem||62 (1.04%)||1.40||(0.72–2.75)||0.072|
|General symptom or complaint, other||51 (0.85%)||1.15||(0.22–6.06)||0.407|
|Bursitis, tendinitis or synovitis||47 (0.79%)||1.06||(0.71–1.60)||0.011|
|Kyphosis and scoliosis||47 (0.79%)||1.06||(0.65–1.75)||0.023|
|Foot or toe symptom or complaint||48 (0.80%)||1.09||(0.41–2.87)||0.123|
|Ankle problem||46 (0.77%)||1.04||(0.40–2.69)||0.112|
|Osteoarthrosis, other (not spine)||39 (0.65%)||0.88||(0.51–1.53)||0.023|
|Hip symptom or complaint||35 (0.58%)||0.79||(0.53–1.19)||0.006|
|Leg or thigh symptom or complaint||35 (0.58%)||0.79||(0.49–1.28)||0.012|
|Musculoskeletal injury||33 (0.55%)||0.75||(0.45–1.24)||0.013|
These findings are impressive in that they suggest that most Australian chiropractors treat non-spinal conditions for which there is no evidence that the most frequently used interventions are effective. The treatments employed are depicted in this graph:
Distribution of techniques and care provided by chiropractors, with 95% CI
[Activator = hand-held spring-loaded device that delivers an impulse to the spine. Drop piece = chiropractic treatment table with a segmented drop system which quickly lowers the section of the patient’s body corresponding with the spinal region being treated. Blocks = wedge-shaped blocks placed under the pelvis.
Chiro system = chiropractic system of care, eg, Applied Kinesiology, Sacro-Occipital Technique, Neuroemotional Technique. Flexion distraction = chiropractic treatment table that flexes in the middle to provide traction and mobilisation to the lumbar spine.]
There is no good evidence I know of demonstrating these techniques to be effective for the majority of the conditions listed in the above table.
A similar bone of contention is the frequent use of ‘maintenance’ and ‘wellness’ care. The authors of the article comment: The common use of maintenance and wellness-related terms reflects current debate in the chiropractic profession. “Chiropractic wellness care” is considered by an indeterminate proportion of the profession as an integral part of chiropractic practice, with the belief that regular chiropractic care may have value in maintaining and promoting health, as well as preventing disease. The definition of wellness chiropractic care is controversial, with some chiropractors promoting only spine care as a form of wellness, and others promoting evidence-based health promotion, eg, smoking cessation and weight reduction, alongside spine care. A 2011 consensus process in the chiropractic profession in the United States emphasised that wellness practice must include health promotion and education, and active strategies to foster positive changes in health behaviours. My own systematic review of regular chiropractic care, however, shows that the claimed effects are totally unproven.
One does not need to be overly critical to conclude from all this that the chiropractors surveyed in this investigation earn their daily bread mostly by being economical with the truth regarding the lack of evidence for their actions.
As promised in the last post, I will try to briefly address the issues which make me uncomfortable about the quotes by Anthony Campbell. Readers will recall that Campbell, an ex-director of what was arguably the most influential homeopathic hospital in the world and a long-time editor of the journal HOMEOPATHY, freely admitted that homeopathy was unproven and its effects were most likely not due to any specific properties of the homeopathic remedies [which are, in fact, pure placebos] but largely rely on non-specific effects.
I agree with much that Campbell wrote but I disagree with one particular implication of his conclusions: “Homeopathy has not been proved to work but neither has it been conclusively disproven….” and “…it is impossible to say categorically that all the remedies are without objective effect…”
This is an argument, we hear from proponents of alternative medicine with unfailing regularity: “MY TREATMENT MAY NOT BE SUPPORTED BY GOOD SCIENCE [BECAUSE GOOD SCIENCE IS EXPENSIVE, AND WE CANNOT AFFORD IT] BUT IT HAS NOT BEEN DISPROVEN EITHER – AND, AS LONG AS IT IS NOT DISPROVEN, NOBODY SHOULD STOP US USING IT”
Campbell does not explicitly draw this latter conclusion but he certainly implies it. In his book, he explains that, even though homeopathic remedies probably are placebos, homeopathy does a lot of good through the placebo effect and through its spiritual aspects. And that is, in his view, sufficient reason to employ it for healing the sick. The very last sentence of his book reads: “Love it or loathe it, homeopathy is here to stay”
So the implication is there: alternative therapies can be as bizarre, nonsensical, implausible, unscientific or idiotic as they like, if we scientists cannot disprove them, they must be legitimate for general use. But there are, of course, two obvious errors in this line of reasoning:
- Why on earth should scientists waste their time and resources on testing notions which are clearly bonkers? It is hard to imagine research that is less fruitful than such an endeavour.
- Disproving homeopathy [or similarly ridiculous treatments] is a near impossibility. Proving a negative is rarely feasible in science.
In the best interest of patients, responsible health care has to follow an entirely different logic: we must consider any treatment to be unproven, while it is not supported with reasonably sound evidence for effectiveness; and in clinical routine, we employ mostly such treatments which are backed by sound evidence, and we avoid those that are unproven. In other words, whether homeopathy or any other medicine is unproven or disproven is of little practical consequence: we try not to use either category.
While I applaud Campbell’s candid judgement regarding the lack of effectiveness of homeopathic remedies, I feel the need to finish his conclusion for him giving it a dramatically different meaning: Homeopathy has not been proved to work but neither has it been conclusively disproven; this means that, until new evidence unambiguously demonstrates otherwise, we should classify homeopathy as ineffective – and this, of course, applies not just to homeopathy but to ALL unproven interventions.
These days, there is so much hype about alternative cancer treatments that it is hard to find a cancer patient who is not tempted to try this or that alternative medicine. Often it is employed without the knowledge of the oncology team, solely on the advice of non-medically qualified practitioners (NMPs). But is that wise? The aim of this survey was to find out.
Members of several German NMP-associations were invited to complete an online questionnaire. The questionnaire explored areas such as the diagnosis and treatment, goals for using complementary/alternative medicine (CAM), communication with the oncologist, and sources of information.
Of a total of 1,500 members of the NMP associations, 299 took part in this survey. The results show that the treatments employed by NMPs were heterogeneous. Homeopathy was used by 45% of the NMPs, and 10% believed it to be a treatment directly against cancer. Herbal therapy, vitamins, orthomolecular medicine, ordinal therapy, mistletoe preparations, acupuncture, and cancer diets were used by more than 10% of the NMPs. None of the treatments were discussed with the respective physician on a regular basis.
The authors concluded from these findings that many therapies provided by NMPs are biologically based and therefore may interfere with conventional cancer therapy. Thus, patients are at risk of interactions, especially as most NMPs do not adjust their therapies to those of the oncologist. Moreover, risks may arise from these CAM methods as NMPs partly believe them to be useful anticancer treatments. This may lead to the delay or even omission of effective therapies.
Anyone faced with a diagnosis of CANCER is understandably keen to leave no stone unturned to bring about a cure of the disease. Many patients thus go on to the Internet and look what alternative options are on offer. There they find virtually millions of sites advertising thousands of bogus cancer ‘cures’. Others consult their alternative practitioners and seek help. This new survey shows yet again that the advice they receive is dangerous. In fact, it might well be even more dangerous than the results imply: the response rate of the survey was dismal, and I fear that the less responsible NMPs tended not to reply.
None of the treatments listed above can cure cancer. For instance, homeopathy, the most popular alternative cancer treatment in Germany, will have no effect whatsoever on the natural history of the disease. To claim otherwise is criminally irresponsible.
But far too many patients are unaware of the evidence and of the dangers of being misled by bogus claims. What we need, I think, is a major campaign to get the word out. It would be a campaign that saves lives!
Informed consent is generally considered to be an essential precondition for any health care practice. It requires the clinician giving the patient full information about the condition and the possible treatments. Amongst other things, the following information may be needed:
- the nature and prognosis of the condition,
- the evidence regarding the efficacy and risks of the proposed treatment,
- the evidence regarding alternative options.
Depending on the precise circumstances of the clinical situation, patient’s consent can be given either in writing or orally. Not obtaining any form of informed consent is a violation of the most fundamental ethics of health care.
In alternative medicine, informed consent seems often to be woefully neglected. This may have more than one reason:
- practitioners have frequently no adequate training in medical ethics,
- there is no adequate regulation and control of alternative practitioners,
- practitioners have conflicts of interest and might view informed consent as commercially counter-productive
In order to render this discussion less theoretical, I will outline several scenarios from the realm of chiropractic. Specifically, I will discuss the virtual case of an asthma patient consulting a chiropractor for alleviation of his symptoms. I should stress that I have chosen chiropractic merely as an example – the issues outlines below apply to chiropractic as much as they apply to most other forms of alternative medicine.
Our patient has experienced breathing problems and has heard that chiropractors are able to help this kind of condition. He consults a ‘straight’ chiropractor who adheres to Palmer’s gospel of ‘subluxation’. She explains to the patient that chiropractors use a holistic approach. By adjusting subluxations in the spine, she is confident to stimulate healing which will naturally ease the patient’s breathing problems. No conventional diagnosis is discussed, nor is there any mention of the prognosis, likelihood of benefit, risks of treatment and alternative therapeutic options.
Our patient consults a chiropractor who does not fully believe in the ‘subluxation’ theory of chiropractic. She conducts a thorough examination of our patient’s spine and diagnoses several spinal segments that are blocked. She tells our patient that he might be suffering from asthma and that spinal manipulation might remove the blockages and thus increase the mobility of the spine which, in turn, would alleviate his breathing problems. She does not mention risks of the proposed interventions nor other therapeutic options.
Our patient visits a chiropractor who considers herself a back pain specialist. She takes a medical history and conducts a physical examination. Subsequently she informs the patient that her breathing problems could be due to asthma and that she is neither qualified nor equipped to ascertain this diagnosis. She tells out patient that chiropractic is not an effective treatment for asthma but that his GP would be able to firstly make a proper diagnosis and secondly prescribe the optimal treatment for her condition. She writes a short note summarizing her thoughts and hands it to our patient to give it to his GP.
One could think of many more scenarios but the three above seem to cover a realistic spectrum of what a patient might encounter in real life. It seems clear, that the chiropractor in scenario 1 and 2 failed dismally regarding informed consent. In other words, only scenario 3 describes a behaviour that is ethically acceptable.
But how likely is scenario 3? I fear that it is an extremely rare turn of events. Even if well-versed in both medical ethics and scientific evidence, a chiropractor might think twice about providing all the information required for informed consent – because, as scenario 3 demonstrates, full informed consent in chiropractic essentially discourages a patient from agreeing to be treated. In other words, chiropractors have a powerful conflict of interest which prevents them to adhere to the rules of informed consent.
AND, AS POINTED OUT ALREADY, THAT DOES NOT JUST APPLY TO CHIROPRACTIC, IT APPLIES TO MOST OF ALTERNATIVE MEDICINE! IT SEEMS TO FOLLOW, I FEAR, THAT MUCH OF ALTERNATIVE MEDICINE IS UNETHICAL.
Dutch neurologists recently described the case of a 63-year-old female patient presented at their outpatient clinic with a five-week history of severe postural headache, tinnitus and nausea. The onset of these symptoms was concurrent with chiropractic manipulation of the cervical spine which she had tried because of cervical pain.
Cranial MRI showed findings characteristic for intracranial hypotension syndrome. Cervical MRI revealed a large posterior dural tear at the level of C1-2. Following unsuccessful conservative therapy, the patient underwent a lumbar epidural blood patch after which she recovered rapidly.
The authors conclude that manipulation of the cervical spine can cause a dural tear and subsequently an intracranial hypotension syndrome. Postural headaches directly after spinal manipulation should therefore be a reason to suspect this complication. If conservative management fails, an epidural blood patch may be performed.
Quite obviously, this is sound advice that can save lives. The trouble, however, is that the chiropractic profession is, by and large, still in denial. A recent systematic review by a chiropractor included eight cases of intracranial hypotension (IH) and concluded that case reports on IH and spinal manipulative therapy (SMT) have very limited clinical details and therefore cannot exclude other theories or plausible alternatives to explain the IH. To date, the evidence that cervical SMT is not a cause of IH is inconclusive. Further research is required before making any conclusions that cervical SMT is a cause of IH. Chiropractors and other health practitioners should be vigilant in recording established risk factors for IH in all cases. It is possible that the published cases of cervical SMT and IH may have missed important confounding risk factors (e.g. a new headache, or minor neck trauma in young or middle-aged adults).
Instead of distracting us from the fact that chiropractic can lead to serious adverse events, chiropractors would be well-advised to face the music, admit that their treatments are not risk-free and conduct rigorous research with a view of minimizing the harm.
The purpose of this paper by Canadian chiropractors was to expand practitioners’ knowledge on areas of liability when treating low back pain patients. Six cases where chiropractors in Canada were sued for allegedly causing or aggravating lumbar disc herniation after spinal manipulative therapy were retrieved using the CANLII database.
The patients were 4 men and 2 women with an average age of 37 years. Trial courts’ decisions were rendered between 2000 and 2011. The following conclusions from Canadian courts were noted:
- informed consent is an on-going process that cannot be entirely delegated to office personnel;
- when the patient’s history reveals risk factors for lumbar disc herniation the chiropractor has the duty to rule out disc pathology as an aetiology for the symptoms presented by the patients before beginning anything but conservative palliative treatment;
- lumbar disc herniation may be triggered by spinal manipulative therapy on vertebral segments distant from the involved herniated disc such as the thoracic spine.
The fact that this article was published by chiropractors seems like a step into the right direction. Disc herniations after chiropractic have been reported regularly and since many years. It is not often that I hear chiropractors admit that their spinal manipulations carry serious risks.
And it is not often that chiropractors consider the issue of informed consent. One the one hand, one hardly can blame them for it: if they ever did take informed consent seriously and informed their patients fully about the evidence and risks of their treatments as well as those of other therapeutic options, they would probably be out of business for ever. One the other hand, chiropractors should not be allowed to continue excluding themselves from the generally accepted ethical standards of modern health care.
When we talk about conflicts of interest, we usually think of financial concerns. But conflicts of interests also extend to non-financial matters, such as strong beliefs. These are important in alternative medicine – I would even go as far as to claim that they dominate this field.
My detractors have often claimed that this is where my problem lies. They are convinced that, in 1993, I came into the job as PROFESSOR OF COMPLEMENTARY MEDICINE with an axe to grind; I was determined or perhaps even paid to show that all alternative medicine is utter hocus-pocus, they say. The truth is that, if anything, I was on the side of alternative medicine – and I can prove it. Using the example of homeopathy, I have dedicated an entire article to demonstrate that the myth is untrue – I was not closed-minded or out to ditch homeopathy (or any other form of alternative medicine for that matter).
What then could constitute my ‘conflict of interest’? Surely, he was bribed, I hear them say. Just look at the funds he took from industry. Some of those people have even gone to the trouble of running freedom of information requests to obtain the precise figures for my research-funding. Subsequently they triumphantly publish them and say: Look he got £x from this company and £y from that firm. And they are, of course, correct: I did receive support from commercially interested parties on several occasions. But what my detractors forget is that these were all pro-alternative medicine institutions. More importantly, I always made very sure that no strings were attached with any funds we accepted.
Our core funds came from ‘The Laing Foundation’ which endowed Exeter University with £ 1.5 million. This was done with the understanding that Exeter would put the same amount again into the kitty (which they never did). Anyone who can do simple arithmetic can tell that, to sustain up to 20 staff for almost 20 years, £1.5 million is not nearly enough. There must have been other sources. Who exactly gave money?
Despite utterly useless fundraising by the University, we did manage to obtain additional funds. I managed to receive support in the form of multiple research fellowships, for instance. It came from various sources; for instance, manufacturers of herbal medicines, Boots, the Pilkington Family Trust (yes, the glass manufacturers).
A hugely helpful contributor to our work was the sizable number (I estimate around 30) of visitors from abroad who came on their own money simply because they wanted to learn from and with us. They stayed between 3 months and 4 years, and importantly contributed to our research, knowledge and fun.
In addition, we soon devised ways to generate our own money. For instance, we started an annual conference for researchers in our field which ran for 14 successful years. As we managed everything on a shoestring and did all the organisation ourselves, we made a tidy profit each year which, of course, went straight back into our research. We also published several books which generated some revenue for the same purpose.
And then we received research funding for specific projects, for instance, from THE PRINCE OF WALES’ FOUNDATION FOR INTEGRATED HEALTH, a Japanese organisation supporting Jorhei Healing, THE WELCOME TRUST, the NHS, and even a homeopathic company.
So, do I have a conflict of interest? Did I take money from anyone who might have wanted to ditch alternative medicine? I don’t think so! And if I tell you that, when I came to Exeter in 1993, I donated ~£120 000 of my own funds towards the research of my unit, even my detractors might, for once, be embarrassed to have thought otherwise.
The most widely used definition of EVIDENCE-BASED MEDICINE (EBM) is probably this one: The judicious use of the best current available scientific research in making decisions about the care of patients. Evidence-based medicine (EBM) is intended to integrate clinical expertise with the research evidence and patient values.
David Sackett’s own definition is a little different: Evidence based medicine 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 expertise with the best available external clinical evidence from systematic research.
Even though the principles of EBM are now widely accepted, there are those who point out that EBM has its limitations. The major criticisms of EBM relate to five themes: reliance on empiricism, narrow definition of evidence, lack of evidence of efficacy, limited usefulness for individual patients, and threats to the autonomy of the doctor/patient relationship.
Advocates of alternative medicine have been particularly vocal in pointing out that EBM is not really applicable to their area. However, as their arguments were less than convincing, a new strategy for dealing with EBM seemed necessary. Some proponents of alternative medicine therefore are now trying to hoist EBM-advocates by their own petard.
In doing so they refer directly to the definitions of EBM and argue that EBM has to fulfil at least three criteria: 1) external best evidence, 2) clinical expertise and 3) patient values or preferences.
Using this argument, they thrive to demonstrate that almost everything in alternative medicine is evidence-based. Let me explain this with two deliberately extreme examples.
CRYSTAL THERAPY FOR CURING CANCER
There is, of course, not a jot of evidence for this. But there may well be the opinion held by crystal therapist that some cancer patients respond to their treatment. Thus the ‘best’ available evidence is clearly positive, they argue. Certainly the clinical expertise of these crystal therapists is positive. So, if a cancer patient wants crystal therapy, all three preconditions are fulfilled and CRYSTAL THERAPY IS ENTIRELY EVIDENCE-BASED.
CHIROPRACTIC FOR ASTHMA
Even the most optimistic chiropractor would find it hard to deny that the best evidence does not demonstrate the effectiveness of chiropractic for asthma. But never mind, the clinical expertise of the chiropractor may well be positive. If the patient has a preference for chiropractic, at least two of the three conditions are fulfilled. Therefore – on balance – chiropractic for asthma is [fairly] evidence-based.
The ‘HOISTING ON THE PETARD OF EBM’-method is thus a perfect technique for turning the principles of EBM upside down. Its application leads us straight back into the dark ages of medicine when anything was legitimate as long as some charlatan could convince his patients to endure his quackery and pay for it – if necessary with his life.