MD, PhD, FMedSci, FRSB, FRCP, FRCPEd.

ethics

One thing that unites all (well, almost all, in my experience) proponents of alternative medicine is their intense dislike for BIG PHARMA. Essentially, they see this sector as:

  1. Driven by profit
  2. Employing unethical means to maximise profit
  3. Not caring for the needs of patients
  4. Attacking alternative medicine for fear of losing profit

And, of course, they claim that alternative medicine, LITTLE ALT MED, is fundamentally different from the cynically capitalist, malign BIG PHARMA.

I have no intention to defend the ways of the pharmaceutical industry – neither on this blog nor anywhere else. This industry is usually responsible to their share-holders and that constellation can lead to excesses which are counter-productive to our needs, to put it mildly. However, what I will question is the notion that LITTLE ALT MED is fundamentally different from BIG PHARMA.

Ad 1

We all have to make a living; to some extend at least we are therefore all driven by our desire to earn money. In alternative medicine, there are certainly not as many mega-enterprises as in the pharmaceutical industry but nobody can deny that many sizable firms exist which make a profit selling alternative remedies of one type or another.

And those parts of alternative medicine which are not into the sale of remedies, you may well ask – think of acupuncture, for instance. Well, those therapists are not exempt either from the need to make a living. Sure, this is on a different scale from BIG PHARMA, but it constitutes still a need for profit. If we multiply the relatively small sums involved by the vast number of therapists, the grand total of LITTLE ALT MED might approach similar orders of magnitude as that of BIG PHARMA.

Ad 2

Ok, but the alternative sector would not employ unethical means for securing or maximising profits! Wrong again, I am afraid.

My 20 years of experience of LITTLE ALT MED have let me witness several incidents which I would not hesitate to call unethical. One of the most recent and least pleasant, from my point of view, was the discovery that several German homeopathic manufacturers had given money to a ‘journalist’ who used these funds to systematically defame me.

Ad 3

What about the charge that BIG PHARMA does not care for the suffering patient? LITTLE ALT MED would never do that!!! Sadly this is a myth too.

Alternative practitioners and their organisations make a plethora of therapeutic claims which are not substantiated. Who would deny that misleading patients into making wrong health care decisions is not the opposite from ‘caring’? What seems even worse, in my view, is the behaviour that might follow the exposure of such behaviour. If someone is courageous enough to disclose the irresponsibility of bogus claims, he might be attacked or even taken to court by those who, in reality should be in the dock or, at least, do their utmost to get their house in order.

Ad 4

Finally, we have the notion of BIG PHARMA trying to suppress LITTLE ALT MED. I call this a myth too because I see absolutely no evidence for this rumour. Even those who circulate it can, when challenged, not produce any.

And, anyway, we all know how many of the big pharmaceutical firms buy into the alternative medicine market as soon as they see a commercially viable opportunity. Does that look like suppression?

So, what is the conclusion? BIG PHARMA can behave badly, no doubt, and when they do, I am as disgusted as the next man. However, LITTLE ALT MED also can behave badly – in fact, wherever there is money to be made, some people will behave badly some of the time.

Perhaps we should not judge an entire sector just by the bad actions of some of its members, but perhaps we should also consider whether or not it has done any good. Who would doubt that BIG PHARMA has helped to save lives – millions of lives?!

And now ask yourself: can we honestly say the same about LITTLE ALT MED?

Chiropractors across the world tend to make false claims. This has been shown with such embarrassing regularity that there is no longer any question about it. Should someone have the courage to disclose and criticises this habit, chiropractors tend to attack their critic, rather than putting their house in order. One of their more devious strategies, in my view, is their insistence on claiming to effectively treat all sorts of childhood conditions.

What could be more evil than treating sick children with ineffective and harmful spinal manipulations? The answer is surprisingly simple: PREVENTING CHILDREN FROM PROFITTING FROM ONE OF THE MOST BENEFICIAL INTERVENTIONS EVER DISCOVERED!

The National Vaccine Information Center (NVIC) is an organisation which seems to support anti-vaxers of various kinds. Officially they try hard to give the image of being neutral about vaccinations and state that they are dedicated to the prevention of vaccine injuries and deaths through public education and to defending the informed consent ethic in medicine. As an independent clearinghouse for information on diseases and vaccines, NVIC does not advocate for or against the use of vaccines. We support the availability of all preventive health care options, including vaccines, and the right of consumers to make educated, voluntary health care choices.

In my view, this is thinly disguised promotion of an anti-vaccination stance. The NVIC recently made the following announcement:

The International Chiropractic Pediatric Association (ICPA), which was founded by Dr. Larry Webster and represents doctors of chiropractic caring for children, has supported NVIC’s mission to prevent vaccine injuries and deaths through public education and to protect informed consent rights for more than two decades. ICPA’s 2013 issue of Pathways to Family Wellness magazine features an article written by Barbara Loe Fisher on “The Moral Right to Religious and Conscientious Belief Exemptions to Vaccination.”

Pathways to Family Wellness is a full-color, quarterly publication that offers parents timely, relevant information about health and wellness options that will help them make conscious health choices for their families. ICPA offers NVIC donor supporters and NVIC Newsletter subscribers a complimentary digital version or print version of Pathways to Family Wellness magazine at a significant discount. Visit the Pathways subscription page and, when checking out in the shopping cart, add the exclusive code: NVIC. 

ICPA also has initiated parenting support groups that meet monthly to discuss health and parenting topics. Meetings are hosted by local doctors of chiropractic and the Pathways website features a directory of local groups. ICPA Executive Director Dr. Jeanne Ohm said “We look forward to many more years of collaborating with NVIC to forward our shared goal of enhancing and protecting the ability of parents to make fully informed health and wellness choices for their children.”

Why, we may well ask, are so many chiropractors against immunisations? The answer might be found in the history of chiropractic. Their founding fathers believed and taught that “subluxations” are the cause of all human diseases. To uphold this ridiculous creed, it was necessary to deny that infections play an important role in many illnesses. In other words, early chiropractors negated the germ theory of disease. Today, of course, they claim that all of this is ancient history – but the stance of many chiropractors against immunisations discloses fairly clearly, I think, that this is not true. Many chiropractic institutions still teach obsolete pseudo-knowledge and many chiropractors seem unable to totally free themselves from such obvious nonsense.

But back to the ICPA: they profess to be a non-profit organization whose mission is to engage and serve family chiropractors worldwide through education, training, and research, establishing evidenced informed practice, excellence in professional skills and unity in a global community which cooperatively and enthusiastically participates in advancing chiropractic for both the profession and the public.

What does “evidence informed practice” mean? This bizarre creation is alarmingly popular with quacks of all kinds and seems to aim at misleading the unsuspecting public. It clearly has little to do with EVIDENCE-BASED PRACTICE as globally adopted by responsible clinicians. If not, the ICPA would inform its members and the public at large that immunisations are amongst the most successful preventive measures in the history of medicine. It is hard to think of another medical intervention where the benefits so clearly and hugely outweigh the risks. Immunisations have saved more lives than most other medical treatments. To not make this crystal clear to concerned parents is, in my view, wholly irresponsible.

Hot flushes are a big problem; they are not life-threatening, of course, but they do make life a misery for countless menopausal women. Hormone therapy is effective, but many women have gone off the idea since we know that hormone therapy might increase their risk of getting cancer and cardiovascular disease. So, what does work and is also risk-free? Acupuncture?

Together with researchers from Quebec, we wanted to determine whether acupuncture is effective for reducing hot flushes and for improving the quality of life of menopausal women. We decided to do this in form of a Cochrane review which was just published.

We searched 16 electronic databases in order to identify all relevant studies and included all RCTs comparing any type of acupuncture to no treatment/control or other treatments. Sixteen studies, with a total of 1155 women, were eligible for inclusion. Three review authors independently assessed trial eligibility and quality, and extracted data. We pooled data where appropriate.

Eight studies compared acupuncture versus sham acupuncture. No significant difference was found between the groups for hot flush frequency, but flushes were significantly less severe in the acupuncture group, with a small effect size. There was substantial heterogeneity for both these outcomes. In a post hoc sensitivity analysis excluding studies of women with breast cancer, heterogeneity was reduced to 0% for hot flush frequency and 34% for hot flush severity and there was no significant difference between the groups for either outcome. Three studies compared acupuncture with hormone therapy, and acupuncture turned out to be associated with significantly more frequent hot flushes. There was no significant difference between the groups for hot flush severity. One study compared electro-acupuncture with relaxation, and there was no significant difference between the groups for either hot flush frequency or hot flush severity. Four studies compared acupuncture with waiting list or no intervention. Traditional acupuncture was significantly more effective in reducing hot flush frequency, and was also significantly more effective in reducing hot flush severity. The effect size was moderate in both cases.

For quality of life measures, acupuncture was significantly less effective than HT, but traditional acupuncture was significantly more effective than no intervention. There was no significant difference between acupuncture and other comparators for quality of life. Data on adverse effects were lacking.

Our conclusion: We found insufficient evidence to determine whether acupuncture is effective for controlling menopausal vasomotor symptoms. When we compared acupuncture with sham acupuncture, there was no evidence of a significant difference in their effect on menopausal vasomotor symptoms. When we compared acupuncture with no treatment there appeared to be a benefit from acupuncture, but acupuncture appeared to be less effective than HT. These findings should be treated with great caution as the evidence was low or very low quality and the studies comparing acupuncture versus no treatment or HT were not controlled with sham acupuncture or placebo HT. Data on adverse effects were lacking.

I still have to meet an acupuncturist who is not convinced that acupuncture is not an effective treatment for hot flushes. You only need to go on the Internet to see the claims that are being made along those lines. Yet this review shows quite clearly that it is not better than placebo. It also demonstrates that studies which do suggest an effect do so because they fail to adequately control for a placebo response. This means that the benefit patients and therapists observe in routine clinical practice is not due to the acupuncture per se, but to the placebo-effect.

And what could be wrong with that? Quite a bit, is my answer; here are just 4 things that immediately spring into my mind:

1) Arguably, it is dishonest and unethical to use a placebo on ill patients in routine clinical practice and charge for it pretending it is a specific and effective treatment.

2) Placebo-effects are unreliable, small and usually of short duration.

3) In order to generate a placebo-effect, I don’t need a placebo-therapy; an effective one administered with compassion does that too (and generates specific effects on top of that).

4) Not all placebos are risk-free. Acupuncture, for instance, has been associated with serious complications.

The last point is interesting also in the context of our finding that the RCTs analysed failed to mention adverse-effects. This is a phenomenon we observe regularly in studies of alternative medicine: trialists tend to violate the most fundamental rules of research ethics by simply ignoring the need to report adverse-effects. In plain English, this is called ‘scientific misconduct’. Consequently, we find very little published evidence on this issue, and enthusiasts claim their treatment is risk-free, simply because no risks are being reported. Yet one wonders to what extend systematic under-reporting is the cause of that impression!

So, what about the legion of acupuncturists who earn a good part of their living by recommending to their patients acupuncture for hot flushes?

They may, of course, not know about the evidence which shows that it is not more than a placebo. Would this be ok then? No, emphatically no! All clinicians have a duty to be up to date regarding the scientific evidence in relation to the treatments they use. A therapist who does not abide by this fundamental rule of medical ethics is, in my view, a fraud. On the other hand, some acupuncturists might be well aware of the evidence and employ acupuncture nevertheless; after all, it brings good money! Well, I would say that such a therapist is a fraud too.

A recent post of mine seems to have stimulated a lively discussion about the question IS THERE ANY GOOD EVIDENCE AT ALL FOR OSTEOPATHIC TREATMENTS? By and large, osteopaths commented that they are well aware that their signature interventions for their most frequently treated condition (back pain) lack evidential support and that more research is needed. At the same time, many osteopaths seemed to see little wrong in making unsubstantiated therapeutic claims. I thought this was remarkable and feel encouraged to write another post about a similar topic.

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

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

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

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

As children cannot give informed consent, this is even more tricky than treating adults with therapies of questionable value. It is therefore important, I think, to ask whether osteopathic treatments of children is based on evidence or just on wishful thinking or the need to maximise income. As it happens, my team just published an article about these issues in one of the highest-ranking paediatrics journal.

The objective of our systematic review was to critically evaluate the effectiveness of osteopathic manipulative treatment (OMT) as a treatment of paediatric conditions. Eleven databases were searched from their respective inceptions to November 2012. Only randomized clinical trials (RCTs) were included, if they tested OMT against any type of control intervention in paediatric patients. The quality of all included RCTs was assessed using the Cochrane criteria.

Seventeen trials met our inclusion criteria. Only 5 RCTs were of high methodological quality. Of those, 1 favoured OMT, whereas 4 revealed no effect compared with various control interventions. Replications by independent researchers were available for two conditions only, and both failed to confirm the findings of the previous studies. Seven RCTs suggested that OMT leads to a significantly greater reduction in the symptoms of asthma, congenital nasolacrimal duct obstruction, daily weight gain and length of hospital stay, dysfunctional voiding, infantile colic, otitis media, or postural asymmetry compared with various control interventions. Seven RCTs indicated that OMT had no effect on the symptoms of asthma, cerebral palsy, idiopathic scoliosis, obstructive apnoea, otitis media, or temporo-mandibular disorders compared with various control interventions. Three RCTs did not report between-group comparisons. The majority of the included RCTs did not report the incidence rates of adverse-effects.

Our conclusion is likely to again dissatisfy many osteopaths: The evidence of the effectiveness of OMT for paediatric conditions remains unproven due to the paucity and low methodological quality of the primary studies.

So, what does this tell us? I am sure osteopaths will disagree, but I think it shows that for no paediatric condition do we have sufficient evidence to show that OMT is effective. The existing RCTs are mostly of low quality. There is a lack of independent replication of the few studies that suggested a positive outcome. And to make matters even worse, osteopaths seem to be violating the most basic rule of medical research by not reporting adverse-effects in their clinical trials.

I rest my case – at least for the moment.

Alternative medicine has the image of being gentle and risk-free; it is therefore frequently used for children. German experts have just published an important article on this rather controversial topic.

They performed a systematic synthesis of all Cochrane reviews in paediatrics assessing the efficacy, clinical implications and limitations of alternative medicine use in children. The main outcome variables were: percentage of reviews concluding that a certain intervention provides a benefit, percentage of reviews concluding that a certain intervention should not be performed, and percentage of studies concluding that the current level of evidence is inconclusive. A total of 135 reviews were included – most from the United Kingdom (29), Australia (24) and China (24). Only 5 (3.7%) reviews gave a recommendation in favour of a certain intervention; 26 (19.4%) issued a conditional positive recommendation. The 5 positive recommendations were:

1) Calcium supplements during pregnancy for prevention of hypertension and related conditions

2) Creatinine supplements for treating muscular disorders

3) Zinc supplements for prevention of pneumonia

4) Probiotics for prevention of upper respiratory infections

5) Acupuncture for prevention of post-operative nausea and vomiting

Nine (6.6%) reviews concluded that certain interventions should not be performed. Ninety-five reviews (70.3%) were inconclusive. The proportion of inconclusive reviews increased over time. The three most common criticisms of the quality of the primary studies included were: more research needed (82), low methodological quality (57) and small number of study participants (48).

The authors concluded: Given the disproportionate number of inconclusive reviews, there is an ongoing need for high quality research to assess the potential role of CAM in children. Unless the study of CAM is performed to the same science-based standards as conventional therapies, CAM therapies risk being perpetually marginalised by mainstream medicine.

As it happens, we published a very similar review two years ago. At the time (and using slightly different inclusion criteria), we identified a total of 17 systematic reviews. They related to acupuncture, chiropractic, herbal medicine, homeopathy, hypnotherapy, massage and yoga. Results were unconvincing for most conditions, but there was some evidence to suggest that acupuncture may be effective for postoperative nausea and vomiting, and that hypnotherapy may be effective in reducing procedure-related pain. Most of the reviews failed to mention the incidence of adverse effects of the alternative treatments in question. Our conclusions were as follows: “Although there is some encouraging evidence for hypnosis, herbal medicine and acupuncture, there is insufficient evidence to suggest that other CAMs are effective for the treatment of childhood conditions. Many of the systematic reviews included in this overview were of low quality, as were the randomised clinical trials within those reviews, further reducing the weight of that evidence. Future research in CAM for children should conform to the reporting standards outlined in the CONSORT and PRISMA guidelines.”

Treating children with unproven or dis-proven therapies is even more problematic than treating adults in this way. The main reason is that children cannot give informed consent. Thus alternative medicine for children can open difficult ethical questions, and sometimes I wonder where the line is between the application of bogus treatments and child-abuse. Examples are parents who opt for homeopathic vaccinations instead of conventional ones, or paediatric cancer patients who are being treated with bogus alternatives such as laetrile.

Why would parents not want the most effective therapy for their children? Why would anyone opt for dubious alternatives? The main reason, I think, must be misinformation. Parents who use alternative medicine are convinced they are effective and safe because they have been misinformed. We only need to google ALTERNATIVE MEDICINE to see for ourselves what utter nonsense and dangerous rubbish is being promoted under this umbrella.

Misinformation is the foremost reason why well-meaning parents (mis-) treat their children with alternative medicine. The results can be disastrous. Misinformation can kill!

A team of Swiss and UK chiropractors just published a survey to determine which management options their colleagues would choose in response to several clinical case scenarios. In order to avoid the accusations of citing out of context, or misreporting the findings in other ways, the wording of the following post is close to the original text of the article.

PART ONE

The clinical scenarios refer to treatments which appear not to be successful, not indicated, possibly harmful or where a patient might be suffering from a treatment-induced complication:

Scenario 1. A patient with non-specific low back pain has not improved at all after 4–6 treatments.

Scenario 2. A patient, who has a simple neck problem with no previous long-term problems, has now improved at least 80% and stayed at this level for a couple of weeks.

Scenario 3. A patient returns from the last treatment with a new distal pain (e.g. sciatica when treated only for localized LBP, or brachialgia when treated only for local neck pain).

Scenario 4. An elderly woman complains about immediate chest pain on inspiration after manual treatment directed to her thoracic spine.

It is worth noting that scenario 4 is the most dramatic but it is by far not the worst case scenario; this would have been the case of a patient who develops signs of a stroke after neck manipulation. It is telling, I think, that this possibility has been excluded in the survey.

The following 9 management options were provided:

• I would re-evaluate the patient with a view to establishing a better diagnosis

• I would send the patient for diagnostic imaging

• I would change my treatment approach and use another technique

• I would send the patient for a second opinion to another healthcare professional but keep on monitoring their condition

• I would try a few times more

• I would encourage the patient to continue the treatment until their spine is subluxation-free

• I would stop treatment and monitor the patient regularly

• I would stop the treatment, apologise and report the event to the chiropractic reporting and learning system

• I would stop the treatment, but tell the patient that s/he is welcome to return if they feel the need

To each of these options, the chiropractors could answer by ticking: ‘never’, ‘unlikely’, ‘likely’ and ‘most likely’.

PART TWO

In a second part of the questionnaire the researchers assessed the chiropractors’ general attitude towards safety issues by seeking the level of agreement on a five-point scale, with the responses ‘strongly disagree’, ‘disagree’, ‘neither agree nor disagree’, ‘agree’ and ‘strongly agree’, with 23 statements relating to six different safety dimensions, as follows:

• Teamwork – helping out, relationships, respect, teamwork-emphasis

• Work pressure – rushing, overwork, staff contingent, patient numbers

• Staff training – in response to new processes, on-the-job, appropriateness of tasks

• Process and standardisation – organisation, procedures, workflow, processes

• Communication openness – ideas for improvement, alternative views, asking questions, voicing disagreement

• Patient tracking/follow-up – reminders, documentation, reports, monitoring

260 Swiss and 1258 UK chiropractors were invited to complete the questionnaire. Responses were received from 76% of the Swiss and from 31% of the UK chiropractors. The dismal response rate for UK chiropractors seems to speak volumes.

The results of this survey indicate that both Swiss and UK chiropractors tend to manage clinical scenarios where treatment appears not to be successful, not indicated, possibly harmful or where a serious complication might have occurred, by re-evaluating their care. Stopping treatment and/or incident reporting to a safety incident reporting and learning system were generally found to be unlikely courses of action. The authors believe that this unlikeliness of safety incident reporting is due to a range of recognised barriers, although Swiss and UK chiropractors are positive about local communication and openness which are important tenets for safety incident reporting. The observed positivity towards key aspects of clinic safety indicates a developing safety culture within the Swiss and UK chiropractic professions.

In this context, scenario 4 is the most dramatic and therefore the most relevant scenario -but, as noted above, not a worst case scenario. It suggested a rib fracture as a result of chiropractic manipulation, with osteoporosis as a possible risk factor. The authors state that there is a strong argument for such an incident to be reported because patient injury occurred and because reflection on the detailed circumstances of the case, shared with colleagues, might serve to minimise the risk of such an occurrence happening elsewhere. However, incident reporting was found to be an unlikely option and comments revealed that this may be due to a perceived connection of reporting with guilt and error, as has been identified with other healthcare reporting initiatives, or only warranted in extreme cases.

The survey also showed that 33% of UK and 48% of Swiss chiropractors seem to work alone. In the eyes of the authors, this is limiting opportunities for fostering a safety culture through activities such as teamwork.

The authors draw the following conclusions:

• This study prompted chiropractors to reflect on aspects of clinical risk.

• Swiss and UK chiropractors tend to manage potentially risky clinical scenarios by reevaluating their care and changing their approach

• Safety incident reporting to an online system is currently an unlikely course of action, probably due to previously recognised barriers, although Swiss and UK chiropractors are positive about local communication and openness which are important tenets for safety incident reporting.

• Barriers to the use of safety incident reporting systems need to be addressed in order to encourage wider use of the existing systems.

• A significant proportion of Swiss and UK chiropractors practice in a single-handed environment. We suggest that single-handed practitioners have most to gain from participation in a national safety incident reporting and learning system.

• Female chiropractors appear to be more risk-averse than male chiropractors.

• Positivity towards key aspects of clinic safety indicate a developing safety culture within the Swiss and UK chiropractic professions.

In my view, the findings of this survey are deeply worrying and the interpretation of the authors is not far from an attempt to ‘white-wash’ the results. Like with most investigations of this nature, the results are wide open to selection bias; particularly the dismal UK response rate begs many questions. In all likelihood, reality is much worse than implied by the results of this investigation. And these results clearly show that, even with a fairly dramatic safety incident, chiropractors fail to respond adequately. There is no doubt in my mind: chiropractors put patients at risk.

Indian homeopaths recently published a clinical trial aimed at evaluating homeopathic treatment in the management of diabetic polyneuropathy. The condition affects many diabetic patients; its symptoms include tingling, numbness, burning sensation in the feet and pain, particularly at night. The best treatment consists of adequate metabolic control of the underlying diabetes. The pain can be severe often does not respond adequately to conventional pain-killers. It is therefore obvious that any new, effective treatment would be more than welcome.

The new trial  is a prospective observational study which was carried out from October 2005 to September 2009 by the Indian Central Council for Research in Homeopathy at its five Institutes. Patients suffering diabetic polyneuropathy (DPN) were screened and enrolled in the study, if they fulfilled the inclusion and exclusion criteria. The Diabetic Distal Symmetric Polyneuropathy Symptom Score (DDSPSS), developed by the Council, served as the primary outcome measure.

A total of 15 homeopathic medicines were identified after repertorizing the nosological symptoms and signs of the disease. The appropriate constitutional medicine was selected and prescribed in the 30, 200 and 1 M potencies on an individualized basis. Patients were followed up for 12 months.

Of 336 diabetics enrolled in the study, 247 patients who attended at least three follow-up appointments and baseline nerve conduction studies were included in the analysis. A statistically significant improvement in DDSPSS total score was found at 12 months. Most objective measures did not show significant improvements. Lycopodium clavatum (n = 132), Phosphorus (n = 27) and Sulphur (n = 26) were the most frequently prescribed homeopathic remedies.

From these results, the authors concluded that: “homeopathic medicines may be effective in managing the symptoms of DPN patients.”

Does this study tell us anything worth knowing? The short answer to this question, I am afraid, is NO.

Its weaknesses are all too obvious:

1) There was no control group.

2) Patients who did not come back to the follow-up appointments – presumably because they were not satisfied – were excluded from the analyses. The average benefit reported is thus likely to be a cherry-picked false positive result.

3) The primary outcome measure was not validated.

4) The observed positive effect on subjective symptoms could be due to several factors which are entirely unrelated to the homeopathic treatments’ e.g. better metabolic control, regression towards the mean, or social desirability.

Anyone who had seen the protocol of this study would have predicted the result; I see no way that such a study does not generate an apparently positive outcome. In other words, conducting the investigation was superfluous, which means that the patients’ participation was in vain; and this, in turn, means that the trial was arguably unethical.

This might sound a bit harsh, but I am entirely serious: deeply flawed research should not happen. It is a waste of scarce resources and patients’ tolerance; crucially, it has a powerful potential to mislead us and to set back our efforts to improve health care. All of this is unethical.

The problem of research which is so poor that it crosses the line into being unethical is, of course, not confined to homeopathy. In my view, it is an important issue in much of alternative medicine and quite possibly in conventional medicine as well. Over the years, several mechanisms have been put in place to prevent or at least minimize the problem, for instance, ethic committees and peer-review. The present study shows, I think, that these mechanisms are fragile and that, sometimes, they fail altogether.

In their article, the authors of the new homeopathic study suggest that more investigations of homeopathy for diabetic polyneuropathy should be done. However, I suggest almost precisely the opposite: unethical research of this nature should be prevented, and the existing mechanisms to achieve this aim must be strengthened.

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.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

The most common pronouncement regarding alternative medicine that I have heard over the years from consumers, health care professionals or decision makers with a liking of alternative medicine goes as follows: “I don’t care how it works, as long as it helps.”

At first glance, this argument seems reasonable, logic and correct; it would be foolish, perhaps even unethical, to reject an effective treatment simply because we fail to understand how its effectiveness comes about – this would not be pragmatic and it is not what we do in medicine: aspirin, for instance, was used and helped many patients long before we understood how it worked. However, once we consider the way this notion is regularly used to defend the use of unproven therapies, we see that, in this context, it is fallacious – in fact, if we dissect it carefully, we find that it  crams three large fallacies in one tiny sentence.

The first thing we notice is that the argument combines two fundamentally different issues which really should be separate  1) the mechanism of action of a therapy and 2) its clinical effectiveness. The matter gets clearer, if we discuss it not in the abstract, but in relation to a concrete example: BACH FLOWER REMEDIES (BFRs). I could have selected many other alternative therapies but BFRs seem fine, particularly as they have so far received no mention on this blog.

Similar to homeopathic preparations, BFRs are so dilute that they do not contain any active ingredients to speak of (they differ from homeopathic preparations, however, in that they do not follow the ‘like cures like’ principle). Several clinical trials of BFRs have been published; collectively, their results show very clearly that the clinical effects of BFRs do not differ from those of placebo. (This does not stop manufacturers selling and consumers buying them; in fact, BFRs are a thriving business.)

The principles backing up BFRs are scientifically implausible, and even BFR-practitioners would probably admit that they have no scientifically defensible idea how their remedies work. Scientists might add that a mechanism of action of such highly dilute remedies is not just unknown but unknowable; there is no way to explain how they work without re-writing several laws of nature.

The overall situation is thus quite clear: BFRs are not effective and there is no plausible mechanism of action.Yet it is hard to deny that many patients feel better after having consulted a BFR-practitioner (or after self-medicating BFRs), and those satisfied customers often insist: “I don’t care how BFRs work, as long as they help me.”

As previously discussed, symptoms can improve for a range of reasons which are related to any specific therapeutic effect: the natural history of the condition, regression towards the mean, placebo-effects etc. Only rigorously controlled trials can tell us whether the therapy or other factors caused the clinical outcome; our perception alone cannot identify cause and effect.

The fact that thousands of patients swear by BFRs, does therefore not constitute proof for their efficacy. The explanation of the apparently different impressions from experience and the results of clinical trials is therefore simple: the empathetic encounter with a therapist and/or a placebo-effect and/or the natural history of the condition are perceived as helpful, while the BFRs are pure placebos.

Back to the notion “I don’t care how this therapy works, as long as it helps” – it turns out to be based on at least three misunderstandings all tightly woven together.

Firstly, it was not the treatment itself that helped, but something else (see above). To imply that the treatment worked is therefore a fallacy.

Secondly, the reference to an unknown mechanism of action is aimed at misleading the opponent: it distracts  from the first fallacy (“the treatment is effective”) by super-imposing a second fallacy (that there might be a mechanism of action). Crucially it attempts to wrong-foot the opponent by implying: “you reject something useful simply because you cannot explain it; this is poor logic and even worse ethics – shame on you!”.

BFR-enthusiasts are bound to see all this quite differently. They will probably claim that a placebo-effect is also a plausible mechanism. “Surely” they might say “this means that BFRs are useful and should be widely employed”.

In proclaiming this, they turn the double-fallacy into a triple fallacy. What they forget is that we do not need a placebo to generate placebo-effects. An effective treatment administered with time, compassion and empathy will, of course, also generate a placebo-effect – what is more, it would generate a specific therapeutic effect on top of it. Thus the BFR are quite useless in comparison. There is rarely a good justification for using placebos in clinical routine.

In conclusion, the often-used and seemingly reasonable sentence “I don’t care how it works, as long as it is helpful  turns out to be a package of fallacies when used to support the use of unproven treatments.

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