The dismal state of chiropractic research is no secret. But is anything being done about it? One important step would be to come up with a research strategy to fill the many embarrassing gaps in our knowledge about the validity of the concepts underlying chiropractic.
A brand-new article might be a step in the right direction. The aim of this survey was to identify chiropractors’ priorities for future research in order to best channel the available resources and facilitate advancement of the profession. The researchers recruited 60 academic and clinician chiropractors who had attended any of the annual European Chiropractors’ Union/European Academy of Chiropractic Researchers’ Day meetings since 2008. A Delphi process was used to identify a list of potential research priorities. Initially, 70 research priorities were identified, and 19 of them reached consensus as priorities for future research. The following three items were thought to be most important:
- cost-effectiveness/economic evaluations,
- identification of subgroups likely to respond to treatment,
- initiation and promotion of collaborative research activities.
The authors state that this is the first formal and systematic attempt to develop a research agenda for the chiropractic profession in Europe. Future discussion and study is necessary to determine whether the themes identified in this survey should be broadly implemented.
Am I the only one who finds these findings extraordinary?
The chiropractic profession only recently lost the libel case against Simon Singh who had disclosed that chiropractors HAPPILY PROMOTE BOGUS TREATMENTS. One would have thought that this debacle might prompt the need for rigorous research testing the many unsubstantiated claims chiropractors still make. Alas, the collective chiropractic wisdom does not consider such research as a priority!
Similarly, I would have hoped that chiropractors perceive an urgency to investigate the safety of their treatments. Serious complications after spinal manipulation are well documented, and I would have thought that any responsible health care profession would consider it essential to generate reliable evidence on the incidence of such events.
The fact that these two areas are not considered to be priorities is revealing. In my view, it suggests that chiropractic is still very far from becoming a mature and responsible profession. It seems that chiropractors have not learned the most important lessons from recent events; on the contrary, they continue to bury their heads in the sand and carry on seeing research as a tool for marketing.
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.
Last week, it was announced that Claus Fritzsche had killed himself on 14 January 2014 at the age of 49. He was an industrious blogger and evangelic promoter of alternative medicine who seemed to spend much of his time and energy to defame those who disagreed with him. In this capacity, he certainly did tirelessly direct ‘ad hominem’ attacks in my direction. When it was revealed, about two years ago, that several German homeopathic firms paid him generously for this activity, his sponsors withdrew with plenty of egg on their faces, and subsequently Fritzsche’s insults became less frequent.
I never met Fritzsche in person but, over the years, I had many email exchanges with him. Invariably, these were unpleasant, to put it mildly. One might admire his tenacity but, from my perspective, it was hard to like Fritzsche. During the last months of his life, I refused to have contact with him, even via email – not because I failed to find our correspondence interesting or amusing, but because our exchanges always ended with some sort of escalation of aggression from his side.
Why then does his death sadden me so deeply?
Any death is a sad event but, if a death is so unnecessary and wasteful, it is particularly depressing. Fritzsche clearly had many skills and a lot of talents. He was young, intelligent and probably was a pleasant person to know personally, at least that is what some people who knew him have said. Alright, we did not agree on many things, but that does not mean that he was a bad person. He just seemed extremely irrational and tragically delivered the ultimate proof for his irrationality through his suicide.
Nobody knows what motivated Fritzsche to kill himself [when Walach speculated that his financial situation following the disclosure of the nature of his sponsorship had anything to do with it, he finds himself yet again way beyond the established facts]. Presumably, he suffered from depression, and presumably he was deeply insecure, and perhaps he was also desperately lonely.
Suspecting that this was the case, I now wish I had continued writing emails to him. Having argument after argument, even at the risk of getting yet again insulted and attacked, might have just been what was required to prevent him sliding into the abyss. I feel sorry for breaking off email contact when, in a strange sense, he might have needed me and the type of irritation people like me seemed to cause him.
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.
The news that the use of Traditional Chinese Medicine (TCM) positively affects cancer survival might come as a surprise to many readers of this blog; but this is exactly what recent research has suggested. As it was published in one of the leading cancer journals, we should be able to trust the findings – or shouldn’t we?
The authors of this new study used the Taiwan National Health Insurance Research Database to conduct a retrospective population-based cohort study of patients with advanced breast cancer between 2001 and 2010. The patients were separated into TCM users and non-users, and the association between the use of TCM and patient survival was determined.
A total of 729 patients with advanced breast cancer receiving taxanes were included. Their mean age was 52.0 years; 115 patients were TCM users (15.8%) and 614 patients were TCM non-users. The mean follow-up was 2.8 years, with 277 deaths reported to occur during the 10-year period. Multivariate analysis demonstrated that, compared with non-users, the use of TCM was associated with a significantly decreased risk of all-cause mortality (adjusted hazards ratio [HR], 0.55 [95% confidence interval, 0.33-0.90] for TCM use of 30-180 days; adjusted HR, 0.46 [95% confidence interval, 0.27-0.78] for TCM use of > 180 days). Among the frequently used TCMs, those found to be most effective (lowest HRs) in reducing mortality were Bai Hua She She Cao, Ban Zhi Lian, and Huang Qi.
The authors of this paper are initially quite cautious and use adequate terminology when they write that TCM-use was associated with increased survival. But then they seem to get carried away by their enthusiasm and even name the TCM drugs which they thought were most effective in prolonging cancer survival. It is obvious that such causal extrapolations are well out of line with the evidence they produced (oh, how I wished that journal editors would finally wake up to such misleading language!) .
Of course, it is possible that some TCM drugs are effective cancer cures – but the data presented here certainly do NOT demonstrate anything like such an effect. And before such a far-reaching claim is being made, much more and much better research would be necessary.
The thing is, there are many alternative and plausible explanations for the observed phenomenon. For instance, it is conceivable that users and non-users of TCM in this study differed in many ways other than their medication, e.g. severity of cancer, adherence to conventional therapies, life-style, etc. And even if the researchers have used clever statistical methods to control for some of these variables, residual confounding can never be ruled out in such case-control studies.
Correlation is not causation, they say. Neglect of this elementary axiom makes for very poor science – in fact, it produces dangerous pseudoscience which could, like in the present case, lead a cancer patient straight up the garden path towards a premature death.
A meta-analysis compared the effectiveness of spinal manipulation therapies (SMT), medical management, physical therapies, and exercise for acute and chronic low back pain. Studies were chosen based on inclusion in prior evidence syntheses. Effect sizes were converted to standardized mean effect sizes and probabilities of recovery. Nested model comparisons isolated non-specific from treatment effects. Aggregate data were tested for evidential support as compared to shams.
The results suggest that, of 84% acute pain variance, 81% was from non-specific factors and 3% from treatment. No treatment was better than sham. Most acute results were within 95% confidence bands of that predicted by natural history alone. For chronic pain, 66% out of 98% was non-specific, but treatments influenced 32% of outcomes. Chronic pain treatments also fitted within 95% confidence bands as predicted by natural history. The evidential support for treating chronic back pain as compared to sham groups was weak, but chronic pain appeared to respond to SMT, while whole systems of chiropractic management did not.
The authors of this intriguing paper conclude: Meta-analyses can extract comparative effectiveness information from existing literature. The relatively small portion of outcomes attributable to treatment explains why past research results fail to converge on stable estimates. The probability of treatment superiority between treatment arms was equivalent to that expected by random selection. Treatments serve to motivate, reassure, and calibrate patient expectations – features that might reduce medicalization and augment self-care. Exercise with authoritative support is an effective strategy for acute and chronic low back pain.
This essentially indicates that none of these treatments for low back pain are convincingly effective. In turn this means we might as well stop using them. Alternatively, we could opt for the therapy that carries the least risks and cost. As the authors point out, this treatment is exercise.
The aim of this survey was to investigate the use of alternative medicines (AMs) by Scottish healthcare professionals involved in the care of pregnant women, and to identify predictors of usage.
135 professionals (midwives, obstetricians, anaesthetists) involved in the care of pregnant women filled a questionnaire. A response rate of 87% was achieved. A third of respondents (32.5%) had recommended (prescribed, referred, or advised) the use of AMs to pregnant women. The most frequently recommended AMs modalities were: vitamins and minerals (excluding folic acid) (55%); massage (53%); homeopathy (50%); acupuncture (32%); yoga (32%); reflexology (26%); aromatherapy (24%); and herbal medicine (21%). Univariate analysis identified that those who recommended AMs were significantly more likely to be midwives who had been in post for more than 5 years, had received training in AMs, were interested in AMs, and were themselves users of AMs. However, the only variable retained in bivariate logistic regression was ‘personal use of AM’ (odds ratio of 8.2).
The authors draw the following conclusion: Despite the lack of safety or efficacy data, a wide variety of AM therapies are recommended to pregnant women by approximately a third of healthcare professionals, with those recommending the use of AMs being eight times more likely to be personal AM users.
There are virtually thousands of websites which recommend unproven treatments to pregnant women. This one may stand for the rest:
Chamomile, lemon balm, peppermint, and raspberry leaf are also effective in treating morning sickness. Other helpful herbs for pregnancy discomforts include:
- dandelion leaf for water retention
- lavender, mint, and slippery elm for heartburn
- butcher’s broom, hawthorn, and yarrow, applied externally to varicose veins
- garlic for high blood pressure
- witch hazel, applied externally to haemorrhoids.
Our research has shown that midwives are particularly keen to recommend and often sell AMs to their patients. In fact, it would be difficult to find a midwife in the UK or elsewhere who is not involved in this sort of thing. Similarly, we have demonstrated that the advice given by herbalists is frequently not based on evidence and prone to harm the unborn child, the mother or both. Finally, we have pointed out that many of the AMs in question are by no means free of risks.
The most serious risk, I think, is that advice to use AM for health problems during pregnancy might delay adequate care for potentially serious conditions. For instance, the site quoted above advocates garlic for a pregnant women who develops high blood pressure during pregnancy and dandelion for water retention. These two abnormalities happen to be early signs that a pregnant women might be starting to develop eclampsia. Treating such serious conditions with a few unproven herbal remedies is dangerous and recommendations to do so are irresponsible.
I think the new survey discussed above suggests a worrying degree of sympathy amongst conventional healthcare professionals for unproven treatments. This is likely to render healthcare less effective and less safe and is not in the interest of patients.
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.