MD, PhD, FMedSci, FRSB, FRCP, FRCPEd

commercial interests

Lyme disease, also known as Lyme borreliosis, is an infectious disease caused by Borrelia infection transmitted by ticks. The most common early sign is an expanding area of redness beginning at the site of a bite about a week after a tick-bite. Fever, tiredness and headaches often follow. Later stages are characterised by more severe and remarkably variable illness.

Patients with medically unexplained or vague symptoms are sometimes told that they suffer from Lyme disease. These patients are commonly targeted by providers of alternative therapies who promise hope by claiming that their particular brand of quackery is effective for this chronic condition.

A recent review was designed to identify and characterize the range of unorthodox alternative therapies advertised to patients with a diagnosis of Lyme disease.

Internet searches using the Google search engine were performed to identify the websites of clinics and services that marketed non-antimicrobial therapies for Lyme disease. Subsequently the PubMed search engine was employed to identify any scientific studies evaluating such treatments for Lyme disease. Websites were included in this review, if they advertised a commercial, non-antimicrobial product or service that specifically mentioned utility for Lyme disease. Websites with patient testimonials (such as discussion groups) were excluded unless the testimonial appeared as marketing on a commercial site.

More than 30 different alternative treatments were identified. They fell into several broad categories: these included oxygen and reactive oxygen therapy; energy and radiation-based therapies; nutritional therapies; chelation and heavy metal therapies; and biological and pharmacological therapies ranging from certain medications without recognized therapeutic effects on Borrelia burgdorgeri to stem cell transplantation. The review of the medical literature did not substantiate efficacy or, in most cases, any rationale for the advertised treatments.

The authors concluded that providers of alternative therapies commonly target patients who believe they have Lyme disease. The efficacy of these unconventional treatments for Lyme disease is not supported by scientific evidence, and in many cases they are potentially harmful.

Being a bacterial infection, Lyme disease can be successfully treated with oral or intra-venous antibiotics. But, of course, patients need to have the infection in order to benefit from antibiotic treatment. Those patients who don’t are easy targets for charlatans promising help from bogus treatments. It seems that an entire, profitable industry has developed around this situation.

The task of UK Clinical Commissioning Groups (CCGs) is to ensure NHS funds are spent as effectively and responsibly as possible. This is particularly important in the current financial climate, as NHS budgets are under enormous pressure. For that reason, The Good Thinking Society (GTS, a pro-science charity) invited Liverpool CCG to reconsider whether the money (~ £ 30,000 pa) they spend on homeopathy represents good service to the public. Recently the CCG agreed to make a fresh decision on this contentious issue.

The GTS would prefer to see limited NHS resources spent on evidence-based medicine rather than on continued funding of homeopathy which, as readers of this blog will know, has repeatedly failed to demonstrate that it is doing more good than harm. It is encouraging to see Liverpool CCG take a first step in the right direction by agreeing to properly consider the best evidence and expertise on this issue.

Supporters of homeopathy frequently cite the concept of patient choice and claim that, if patients want homeopathy, they should have it free on the NHS. The principle is obviously important, but it is crucial that this choice is an informed one. The best evidence has conclusively shown that homeopathy is not an effective treatment, and to continue to offer ineffective treatments under the guise of patient choice raises troubling questions about the important concept of informed choice, and indeed of informed consent as well as medical ethics.

The GTS were represented by Salima Budhani and Jamie Potter of Bindmans LLP. Salima said: “This case underlines the necessity of transparent and accountable decision making by the controllers of health budgets, particularly in the light of the current financial climate in the NHS. CCGs have legal obligations to properly consider relevant evidence, as well as the views of experts and residents, in deciding how precious NHS resources are to be spent. It is essential that commissioning decisions are rational and evidence-based. Liverpool CCG’s decision to reconsider its position on the funding of homeopathy in these circumstances is to be welcomed.

“Our client has also called upon the Secretary of State for Health to issue guidance on the funding of homeopathy on the NHS. Public statements by the Secretary of State indicate that he does not support ongoing funding, yet he has so far declined to ask NICE to do any work on this issue. The provision of such guidance would be of significant benefit to CCGs in justifying decisions to terminate funding.”

Commenting on their decision, a Liverpool CCG spokesperson said: “Liverpool CCG currently resources a small homeopathy contract to the value of £30,000 per year that benefits a small number of patients in the city who choose to access NHS homeopathy care and treatment services. The CCG has agreed with the Good Thinking Society to carry out further engagement with patients and the general public to inform our future commissioning intentions for this service.”

Over the last two decades, prescriptions fulfilled in community pharmacies for homeopathy on the NHS in England have fallen  by over 94% and homeopathic hospitals have seen their funding reallocated. This reduction indicates that the majority of doctors and commissioning bodies have acted responsibly by terminating funding for homeopathic treatments.

The GTS are currently fundraising in order to fund further legal challenges – donate now to support our campaign at justgiving.com/Good-Thinking-Society-Appeal/.

The Paleo diet is based on the evolutionary discordance hypothesis, according to which departures from the nutrition and activity patterns of our hunter-gatherer ancestors have contributed greatly and in specifically definable ways to the endemic chronic diseases of modern civilization. The assumption is that during the Paleolithic era — a period lasting around 2.5 million years that ended about 10,000 years ago with the advent of agriculture and domestication of animals — humans evolved nutritional needs specific to the foods available at that time, and that the nutritional needs of modern humans remain best adapted to the diet of their Paleolithic ancestors. Today’s humans are said to be not well adapted to eating foods such as grain, legumes, and dairy, and in particular the high-calorie processed foods. Proponents claim that modern humans’ inability to properly metabolize these comparatively new types of food has led to modern-day problems such as obesity, heart disease, and diabetes. They furthermore claim that followers of the Paleolithic diet may enjoy a longer, healthier, more active life.

The Paleo Diet is alleged to work by two fundamental principles:

  •  Put the optimal nutrition into your body.
  •  Reduce or eliminate toxins and “interference”.

And what are the results, as claimed by those who promote (and profit from) the Paleo diet? The alleged benefits include:

  • Leaner, Stronger Muscles
  • Increased Energy
  • Significantly More Stamina
  • Clearer, Smoother Skin
  • Weight Loss Results
  • Better Performance and Recovery
  • Stronger Immune System
  • Enhanced Libido
  • Greater Mental Clarity
  • No More Hunger/Cravings
  • Thicker, Fuller Hair
  • Clear Eyes

Critics of the Paleo diet point towards abundant evidence that paleolithic humans did, in fact, eat grains and legumes. They also stress that humans are much more nutritionally flexible than previously thought, that the hypothesis that Paleolithic humans were genetically adapted to specific local diets is unproven, that the Paleolithic period was extremely long and saw a variety of forms of human settlement and subsistence in a wide variety of changing nutritional landscapes, and that currently very little is known for certain about what Paleolithic humans ate.

So, the theories behind the Paleo diet are flimsy and naïve; the most crucial question, however, is does it work?

Overall there is little solid evidence; unsurprisingly, some studies have shown that cardiovascular risk factors can be positively influenced, for instance, in patients with diabetes. But the more specific claims, like the ones above, are not supported by good clinical evidence.

It seems that, yet again, less than responsible entrepreneurs have jumped on a popular band-wagon to exploit the often hopelessly gullible public.

The Telegraph today reports that, despite relentless lobbying from the Prince of Wales, UK  herbalists will not, after all, be regulated by statute. Here are the most important statements from this article:

Prof David Walker, deputy chief medical officer, said he had taken the decision because there was insufficient evidence that the alternative therapy works, making it impossible to set standards of good practice. Three years ago ministers had pledged to bring in an official register of practitioners of herbal and Chinese medicines, which would see therapists regulated alongside other health workers, such as physiotherapists and speech therapists…But ministers blocked the proposals, instead setting up a new committee, led by the NHS deputy chief medical officer – which has now ruled against statutory regulation. The decision came despite lobbying from Prince Charles, a keen advocate of complementary medicines, and a supporter of regulation, who held a meeting with Jeremy Hunt in 2013 in which his concerns were raised…Prof Walker said that although most herbal practitioners were in favour of regulation, those opposed to it feared it would “confer an inappropriate level of legitimacy on herbal practice which was poorly supported by scientific evidence.” He said the decision to rule against regulation was “undoubtedly the most contentious area” addressed by the working party, which also looked at the safety of herbal medicine products. Instead, the report calls for a review of all ingredients sold in such medicines, to check their safety, with a “voluntary register” for practitioners who use them. It says there is too little evidence to show that herbal medicines improve health outcomes, making it “difficult to establish the boundaries of good practice” in regulating practitioners. It also says there is very little understanding of the risks posed to patients from current practices in herbal medicine…Prof Walker’s recommendation has triggered an immediate rift among the 26 members of his working party. Twelve members of the working party have written to Dr Dan Poulter, health minister, alleging that the decision will put the safety of the public at risk, because anyone will be able to promote themselves as an expert in herbal medicine, without any training. Research suggests around three million Britons a year consult herbal practitioners, operating in shops, online and in private clinics, with up to one in 12 of all adults using a herbal medicine at some stage. Michael McIntyre, chairman of the European Herbal and Traditional Medicine Practitioners Association, said the decision not to regulate practitioners could put the public at risk from rogue operators, with no training. The herbal practitioner, who was a member of the DoH working party, said: “We are deeply disappointed by this. We feared this issue was going to be kicked into the long grass, by quietly putting something out just before the election – and that is exactly what has happened.” He said the public needed the reassurance of statutory regulation, to know that any herbal doctor who is practising had received some training. The association disputed claims there was insufficient evidence to show that herbal medicines worked, saying that several trials had shown its impact for a number of conditions, but that the sector had less money than the pharmaceutical industry had to undertake mass research. The report says that although ministers promised “some form of regulation of herbal practitioners” this only committed the working party to consider the options, and that the introduction of regulation would require the sector to be “more science and evidence-based”.

Perhaps I should first state that I was not involved in any way in this process. Furthermore, I must say that I do think it is the right decision. To understand it better, I need to refer to several previous posts: yes, some herbal medicines are demonstrably effective. But the regulation in question is NOT about herbal medicines; it is about herbal practitioners, and the two are not necessarily related. UK herbal practitioners practice within a range of  traditions including traditional European herbalism, TCM, or other schools of thought. They differ vastly but have one characteristic in common: they individualise their prescriptions according to the specific characteristics of the patient. Thus they would rarely prescribe the evidence-based herbal medicines but mix up prescriptions composed of several herbal ingredients. The problems with this approach are numerous:

  • there is no good evidence that this approach of individualised herbalism is effective;
  • the safety of the herbs used by traditional herbalists is often unknown;
  • traditional herbalists tend to use obsolete diagnostic techniques, false-positive and false-negative diagnoses are thus inevitable;
  • some of the herbal mixtures have been shown to be contaminated with toxic ingredients;
  • some mixtures are adulterated with powerful prescription drugs;
  • the herbal ingredients could interact with each other in an unpredictable manner;
  • the herbal mixtures might interact with prescribed drugs.

The long and short of it is that nobody knows whether the treatments of traditional herbalists generate more good than harm. Regulating these professions by statute would merely give them a level of credibility that they do not deserve. As with the regulation of chiropractors or osteopaths in the UK, the regulation of herbalists would simply misled the public about the value of traditional herbalism, and it most likely would have prompted the herbalists to happily rest on their assumed merits claiming that their effectiveness and safety has been officially acknowledged and is therefore no longer in doubt.

In a nutshell: THE ‘PROPER’ REGULATION OF NONSENSE GENERATES PROPER NONSENSE

I have argued since many years that pharmacists should not be selling or promoting homeopathic and other remedies for which there is no proof of efficacy – the last time I published my view on this matter is even less than a week ago: Personally, I would go another step further and remind pharmacists who sell homeopathic remedies to the unsuspecting public that it is unethical to pretend they are more than placebos.

Despite my insistence and despite the fact that many agree with me (at least privately), there are precious few pharmacists who actually do something meaningful about the current situation. And there is very little visible change: in the UK, it is currently hard to find a pharmacy where homeopathic remedies are not on the shelves, and certainly all the major chains seem to put money before health care ethics.

I am, of course, speaking about the situation in the UK, France, Germany and some other European countries. Perhaps elsewhere things are different?

A NZ website seems to indicate that ‘down under’ the pharmacists are getting more active. Some strongly argue against unproven or disproven remedies in pharmacies:

Firstly, …it’s not a case that “pharmacists ‘should’ only be selling health products for which there is credible evidence of efficacy” (alterations mine, emboldened) but that they are obliged to—but choose not to. Their ethical guidelines state –

[PHARMACISTS] MUST:… Only purchase, supply or promote any medicine, complementary therapy, herbal remedy or other healthcare product where there is no reason to doubt its quality or safety and when there is credible evidence of efficacy.

…Secondly, the argument that ‘other businesses sell junk remedies therefore we shall’ is unsound. One of the key points about the ethical regulations for pharmacies is that customers should be able to walk into a store and have an expectation that the remedies within the store are basically sound. If other businesses elect to be unsound, that’s poor health practice, but no justification to do likewise. On the face of it, it would seem that the profit motive is ruling over sound and ethical practice.

Thirdly, that some GPs subscribe placebos should have no standing in this. There is some arguments for GPs to prescribe placebo remedies in some cases; others would argue that education is a better response in most cases. Either way—and just my opinion—it seems to me that GPs prescribing homeopathic remedies encourages people to think these have real remedial effects. I don’t work within the industry, but I am sure are ways of offering placebos that avoid using off-the-shelf commercial products. One might be that patients only get placebo ‘treatments’ via prescription.

…Fourthly, Pharmacy Today encourages that “pharmacies need to reconsider their stance in the light of this report”***. While this is an excellent idea, and one I thoroughly support, I suspect the underlying driver isn’t the report, but media presence on the topic. There is a long trail of evidence over many years showing that homeopathic remedies are not effective for anything.

The Australian study*** that prompted the latest round of interest drew this statement,

Based on the assessment of the evidence of effectiveness of homeopathy, NHMRC concludes that there are no health conditions for which there is reliable evidence that homeopathy is effective.

Homeopathy should not be used to treat health conditions that are chronic, serious, or could become serious. People who choose homeopathy may put their health at risk if they reject or delay treatments for which there is good evidence for safety and effectiveness. People who are considering whether to use homeopathy should first get advice from a registered health practitioner.* Those who use homeopathy should tell their health practitioner and should keep taking any prescribed treatments.

The National Health and Medical Research Council expects that the Australian public will be offered treatments and therapies based on the best available evidence.

…Why were the relevant professional bodies not onto this evidence sooner?…

GOOD QUESTION!

I might add another one: why are the European professional bodies of pharmacy doing so little about this ongoing breach of their own ethical codes?

(*** the report that the author refers to is the one by the Australian National Health and Medical Research Council we discussed on this blog a few days ago.)

My memoir ‘A SCIENTIST IN WONDERLAND’ continues to get rather splendid reviews. On 23 March, it will be published also in a German edition. Probably a good time to post another short excerpt from it.

The following episode gives just one of many examples of attempts by my Exeter peers to sabotage my scientific, moral and ethical standards. The players in this scene are:

By the year 2000, I began to experience unnecessary unpleasantness at Exeter on a more and more regular basis. This passage from my book describes the key moment when it became clear to me that something profoundly wrong was going on:

The watershed came in 2003, when I saw an announcement published in the newsletter of the Prince of Wales’ Foundation for Integrated Health:

“The Peninsula Medical School aims to become the UK’s first medical school to include integrated medicine at postgraduate level. The school also plans to extend the current range and depth of programmes offered by including healthcare ethics and legislation. Professor John Tooke, dean of the Peninsula Medical School, said: “The inclusion of integrated medicine is a patient driven development. Increasingly the public is turning to the medical profession for information about complementary medicines. This programme will play an important role in developing critical understanding of a wide range of therapies”.

When I stumbled on this announcement, I was truly puzzled. Tooke is obviously planning a new course for me, I thought, but why has he not told me about it? When I enquired, Tooke informed me that the medical school was indeed preparing to offer a postgraduate “Pathway in Integrated Health”; this exciting new innovation had been initiated by Dr Michael Dixon, a general practitioner who, after working in collabora-tion with my unit for several years, had become one of the UK’s most outspoken proponents of spiritual healing and other similarly dubious forms of alternative medicine. For this reason, Dixon was apparently very well regarded by Prince Charles.

A few days after I had received this amazing news, Dixon arrived at my office and explained, with visible embarrassment, that Prince Charles had expressed his desire to him personally to establish such a course at Exeter. His Royal Highness had already facilitated its funding which, in fact, came from “Nelsons”, one of the UK’s largest manufacturers of homeopathic remedies. The day-to-day running of the course was to be put into the hands of the ex-director of the Centre for Complementary Health Studies (CCHS), the very unit that, almost a decade earlier, I had struggled—and eventually even paid—to be separated from because of its overtly anti-scientific agenda. The whole thing had been in the planning for many months. I was, it seemed, the last to know—but now that I had learnt about it, Dixon and Tooke leaned on me with all their might to persuade me to contribute to this course by giving a few lectures.

I could no more comply with this request than fly. Apart from anything else, anyone who had read my papers would have known that I was opposed in principle to the concept of “Integrated Health”. As I saw it, “integrating” quackery with genuine, science-based medicine was nothing less than a profound betrayal of the ethical basis of medical practice. By putting its imprimatur on this course, and by offering it under the auspices of a mainstream medical school, my institution would be encouraging the dangerously erroneous idea of equivalence—i.e. the notion that alternative and mainstream medicine were merely two parallel but equally valid and effective methods of treating illness.

To add insult to injury, the course was to be run by someone who I had good reason to reject and sponsored by a major manufacturer of homeopathic remedies. In all conscience, the latter circumstance seemed to me to be the last straw. Study after study carried out by my unit had found homeopathy to be not only conceptually absurd but also therapeutically worthless. To all intents and purposes, the discussion about the value of homeopathy was closed. Even a former director of the Royal London Homeopathic Hospital had concluded in his book that “homeopathy has not been proved to work… the great majority… of the improvement that patients experience is due to non-specific causes”. If we did not take a stand on this issue, we might as well give up and go home. Consequently, I politely but firmly declined the offer of participating in this course.
By now numerous other incidents of a similar nature had poisoned the atmosphere at my own medical school and university so much that both my work and my health were suffering. How had it come to this? Why was even the most obvious and demonstrable truth being turned upside down so that it could be used against me? Why were my peers seemingly bent on constraining me and making life increasingly difficult for me?

According to Bloomberg Markets, A Nelson & Co Ltd. manufactures and markets natural healthcare products. The company offers arnica creams that provide natural first aid for bruises; plant and flower based remedies that help in managing the emotional demands of everyday life; and over-the-counter homeopathic medicines for everyday ailments, such as relief from travel sickness and relief for the symptoms of hay fever. It also provides hemorrhoid relief creams and soothing hygienic wipes; anti-blemish range products for various skin types and age groups; multi-purpose cream that helps to soothe and restore skin; iron supplements; teething granules that provide relief from the symptoms and discomfort of teething; a range of creams, ointments, and sprays for a range of common skin conditions/complaints; and a range of commonly used herbal remedies. The company offers products for ailments, including aches and pains, mild anxiety, babies and children, colds and minor infections, digestion, emotional health, energy, everyday stresses, first aid, getting older, pets, quit smoking, skin, sleep, travel, and women’s health. It also operates a clinic; and a pharmacy that offers homeopathy and complementary healthcare products. The company offers its products through its pharmacy in the United Kingdom; and distributors in Europe, Latin America, and internationally. It also serves customers online. The company was formerly known as Armbrecht, Nelson & Co. The company was founded in 1860 and is based in London, United Kingdom with subsidiary offices in Boston, Massachusetts; and Hamburg, Germany. A Nelson & Co Ltd. operates as a subsidiary of Nelson and Russell Holdings Ltd.

In the journal ‘Chemist and Druggist’ we find an article informing us that, in 1930, Nelsons Homeopathic Pharmacy was approached by Dr Edward Bach who wanted help making and selling his products. He had created 38 flower remedies to rebalance emotions and later created an emergency remedy, a combination of five flower remedies that became Rescue. The relationship between Nelsons and the Dr Edward Bach Centre, based at Dr Bach’s former home at Mount Vernon in Oxfordshire, continues to this day and both the Bach Original Flower Remedies and Rescue are key ranges for Nelsons.

Nelson’s homeopathic pharmacy has a proud history:

Ernst Louis Armbrecht, a German pharmacist and disciple of Samuel Hahnemann, came to London and founded Nelsonsin 1860. Since then, Nelsons has been supplying homeopathic medicines. “Our wish today” they state “is the same as 152 years ago: to make homeopathy accessible and to provide the highest standards of medicine and advice.”

The highest standards of medicine and advice? It seems that the Advertising Standards Authority (ASA) disagrees. A recent ASA Adjudication on A Nelson & Co Ltd deals with an advertisement by Nelsons for ‘Bach Rescue Night’ which stated “I CAN’T SWITCH OFF…The RESCUE NIGHT range helps your mind switch off, so you can enjoy a natural night’s sleep”

A freelance health writer had challenged whether the claims “I can’t switch off … Rescue Night range helps your mind switch off, so you can enjoy a natural night’s sleep” was an authorised health claim in the EU Register of Nutrition and Health Claims for Foods (the EU Register).

The ASA noted that, according to EC Regulation 1924/2006 on Nutrition and Health Claims made on Foods (the Regulation), which was reflected in the CAP Code, only health claims which appeared on the list of authorised health claims (the Register) could be made in ads promoting foods, including food supplements. Health claims were defined as those that stated, suggested or implied that a relationship existed between a food category, a food or one of its constituents and health.

The ASA furthermore stated: We acknowledged Rescue Remedy’s assertion that their ad had not made specific claims to aid sleep or that it improved sleep. However, we considered that the use of visuals such as a crescent moon and stars on a dark background, that the letter ‘O’ in the word “OFF” resembled a simple on/ off light switch image, the text “… you can enjoy a natural night’s sleep” and the name of the product “Rescue Night” was likely to give the impression to consumers that it was a product that would aid sleep or that it would help consumers fall asleep easily. We understood that ‘unwanted thoughts’ was one reason why consumers might find it difficult to get to sleep and, again, considered this added to the impression that the product would contribute positively to sleep. We therefore considered that the ad made a health claim related to sleep involving a food item.

We understood that some Bach Flower Remedies contained levels of alcohol which would preclude them from bearing health claims altogether, however, we noted that Bach Rescue Night was alcohol free. We acknowledged Rescue Remedy’s points regarding EFSA and ‘on hold’ claims for botanicals. We understood that ‘on hold’ claims for such botanicals could be used in marketing, provided such use had the same meaning as the proposed claim and they were used in compliance with applicable existing national provisions (in this case the CAP Code). However, Rescue Remedy did not provide evidence that relevant proposed claims for white chestnut, or any of the other product ingredients were ‘on hold’. Nevertheless, we understood that there were no ‘on hold’ claims entered onto the Register for white chestnut or the other product ingredients. Furthermore, ‘on hold’ claims should also be supported with adequate substantiation which we did not receive.

Because the ad made health claims relating to Bach Rescue Night as a sleep aid and we had not seen evidence that relevant claims for the botanical ingredients contained in the product were ‘on hold’, we concluded that the ad breached the Code.

The ad breached CAP Code (Edition 12) rules 15.1, 15.1.1 and 15.7 (Food, food supplements and associated health or nutritional claims).

The ASA ruled that the ad must not appear again in its current form. We told A Nelson & Co Ltd t/a rescueremedy.co.uk not to make health claims for botanical ingredients if they did not comply with the requirements of the Regulation.

I am afraid that such a ruling will have very little effect on the sale of Bach Flower Remedies. In case you have any doubt, I should mention that these inventions of Dr Bach are not supported by good evidence. Here is the abstract of my systematic review on the subject:

Bach flower remedies continue to be popular and its proponents make a range of medicinal claims for them. The aim of this systematic review was to critically evaluate the evidence for these claims. Five electronic databases were searched without restrictions on time or language. All randomised clinical trials of flower remedies were included. Seven such studies were located. All but one were placebo-controlled. All placebo-controlled trials failed to demonstrate efficacy. It is concluded that the most reliable clinical trials do not show any differences between flower remedies and placebos.

Bach Flower Remedies have no effect whatsoever!

Come to think of it, this is not entirely true: they obviously keep the ASA busy, they exploit the gullible public, and they are clearly good for the cash flow at Nelson’s.

Chiropractors like to promote themselves as primary healthcare professionals. But are they? A recent survey might go some way towards addressing this question. It was based on a cross sectional online questionnaire distributed to 4 UK chiropractic associations. The responses were collected over a period of two months from March 26th 2012 to May 25th 2012.

Of the 2,448 members in the 4 participating associations, 509 chiropractors (~21%) completed the survey. The results of the survey show that the great majority of UK chiropractors surveyed reported evaluating and monitoring patients in regards to posture (97.1%), inactivity/overactivity (90.8%) and movement patterns (88.6%). Slightly fewer provided this type of care for psychosocial stress (82.3%), nutrition (74.1%) and disturbed sleep (72.9%). Still fewer did so for smoking (60.7%) and over-consumption of alcohol (56.4%). Verbal advice given by the chiropractor was reported as the most successful resource to encourage positive lifestyle changes as reported by 68.8% of respondents. Goal-setting was utilised by 70.7% to 80.4% of respondents concerning physical fitness issues. For all other lifestyle issues, goal-setting was used by approximately two-fifths (41.7%) or less. For smoking and over-consumption of alcohol, a mere one-fifth (20.0% and 20.6% respectively) of the responding chiropractors set goals.

The authors of this survey concluded that UK chiropractors are participating in promoting positive lifestyle changes in areas common to preventative healthcare and health promotion areas; however, more can be done, particularly in the areas of smoking and over-consumption of alcohol. In addition, goal-setting to support patient-provider relationships should be more widespread, potentially increasing the utility of such valuable advice and resources.

When I saw that a new UK-wide survey of chiropractic has become available, I had great expectations. Sadly, they were harshly disappointed. I had hoped that, after going to the considerable trouble of setting up a nationwide survey of this nature, we would have some answers to the most urgent questions that currently plague chiropractic and are amenable to study by survey. In my view, some of these questions include:

  • How many chiropractors actually see themselves as primary care professionals?
  • What conditions do chiropractors treat?
  • Specifically how many of them believe they can treat non-spinal conditions effectively?
  • How many chiropractors regularly treat children?
  • For which conditions?
  • How many patients get X-rayed by chiropractors?
  • How many are in favour of vaccinations?
  • How many are aware of adverse effects of spinal manipulation?
  • How chiropractors obtain informed consent before starting treatment?
  • What percentage of chiropractors use spinal manipulation?
  • What other treatments are used how often?
  • How often do chiropractors advise their patients about medications prescribed by real doctors?
  • How often do they refer patients to other health care providers?

All of these questions are highly relevant and none of them has recently been studied. But, sadly, the new paper does not answer them. Why? As I see it, there are several possibilities:

  • Chiropractors do not find these questions as relevant as I do.
  • They do not want to know the answers.
  • They do not like to research issues that might shine a bad light on them.
  • They view research mostly as a promotional exercise.
  • They did research (some of) these questions but do not dare to publish the results.
  • They will publish the results in a separate paper.

It would be interesting to hear from the authors which possibility applies.

Chinese proprietary herbal medicines (CPHMs) are a well-established and a hugely profitable part of Traditional Chinese Medicine (TCM) with a long history in China and elsewhere; they are used for all sorts of conditions, not least for the treatment of common cold. Many CPHMs have been listed in the ‘China national essential drug list’ (CNEDL), the official reference published by the Chinese Ministry of Health. One would hope that such a document to be based on reliable evidence – but is it?

The aim of a recent review was to provide an assessment on the potential benefits and harms of CPHMs for common cold listed in the CNEDL.

The authors of this assessment were experts from the Chinese ‘Centre for Evidence-Based Medicine’ and one well-known researcher of alternative medicine from the UK. They searched CENTRAL, MEDLINE, EMBASE, SinoMed, CNKI, VIP, China Important Conference Papers Database, China Dissertation Database, and online clinical trial registry websites from their inception to 31 March 2013 for clinical studies of CPHMs listed in the CNEDL for common cold.

Of the 33 CPHMs listed in the 2012 CNEDL for the treatment of common cold, only 7 had any type of clinical trial evidence at all. A total of 6 randomised controlled trials (RCTs) and 7 case series (CSs) could be included in the assessments.

All these studies had been conducted in China and published in Chinese. All of them were burdened with poor study design and low methodological quality, and all had to be graded as being associated with a very high risk of bias.

The authors concluded that the use of CPHMs for common cold is not supported by robust evidence. Further rigorous well designed placebo-controlled, randomized trials are needed to substantiate the clinical claims made for CPHMs.

I should state that it is, in my view, most laudable that the authors draw such a relatively clear, negative conclusion. This does certainly not happen often with papers originating from China, and George Lewith, the UK collaborator in this article, is also not known for his critical attitude towards alternative medicine. But there are other, less encouraging issues here to mention.

In the discussion section of their paper, the authors mention that the CNEDL has been approved by the Chinese Ministry of Public Health and is currently regarded as the accepted reference point for the medicines used in China. They also explain that the CNEDL was officially launched and implemented in August 2009. The CNEDL is now up-dated every 3 years, and its 2012 edition contains 520 medicines, including 203 CPHMs. The CPHMs listed in CNEDL cover 137 herbal remedies for internal medicine, 11 for surgery, 20 for gynaecology, 7 for ophthalmology, 13 for otorhinolaryngology and 15 for orthopaedics and traumatology.

Moreover, the authors inform us that about 3,100 medical and clinical experts had been recruited to evaluate the safety, effectiveness and costs of CPHMs. The selection process of medicines into CNEDL was strictly in accordance with the principle that they ‘must be preventive and curative, safe and effective, affordable, easy to use, think highly of both Chinese and Western medicine’. A detailed procedure for evaluation is, however, not available because the files are confidential.

The authors finally state that their paper demonstrates that the selection of CPHMs into the CNEDL is less likely to be ‘evidence-based’ and revealed the sharp contrast between the policy and priority given to by the Chinese government to Traditional Chinese Medicine(TCM).

This surely must be a benign judgement, if there ever was one! I would say that the facts disclosed in this review show that TCM seems to exist in a strange universe where commercial interests are officially allowed to reign supreme over patients’ interests and public health.

Neck pain is a common problem which often causes significant disability. Chiropractic manipulation has become one of the most popular forms of alternative treatment for such symptoms. This seems surprising considering that neck manipulations are neither convincingly effective nor free of adverse effects.

The current Cochrane review on this subject could not be clearer: “Done alone, manipulation and/or mobilization were not beneficial; when compared to one another, neither was superior.” In the absence of compelling evidence for efficacy, any risk of neck manipulation would tilt the risk/benefit balance into the negative.

Adverse effects of neck manipulations range from mild symptoms, such as local neck tenderness or stiffness, to more severe injuries involving the spinal cord, peripheral nerve roots, and arteries within the neck. A recent paper reminds us that another serious complication has to be added to this already long list: phrenic nerve injury.

The phrenic nerve is responsible for controlling the contractions of the diaphragm, which allows the lungs to take in and release air and make us breathe properly. The phrenic nerve is formed from C3, C4, and C5 nerve fibres and descends along the anterior surface of the scalenus anterior muscle before entering the thorax to supply motor and sensory input to the diaphragm. Its anatomic location in the neck leaves it vulnerable to traumatic injury. Phrenic nerve injury can result in paralysis of the diaphragm and often leads to deteriorating function of the diaphragm, which can lead to partial or complete paralysis of the muscle and, as a result, serious breathing problems.

Patients who experience such problems may require emergency medical treatment or surgery. Sudden, severe damage to the phrenic nerve can make it impossible for the diaphragm to contract on its own. In order to make sure that the patient can breathe, a breathing tube needs to be inserted, a process called intubation. Artificial respiration would then be required.

American neurologists published a case report of a healthy man who consulted a chiropractor for his neck pain. Predictably, the chiropractor employed cervical manipulation to treat this condition. The result was bilateral diaphragmatic paralysis.

Similar cases have been reported previously, for instance, here and here and here and here. Damage to other nerves has also been documented to be a possible complication of spinal manipulation, for instance, here and here.

The authors of this new case report conclude that physicians must be aware of this complication and should be cautious when recommending spinal manipulation for the treatment of neck pain, especially in the presence of preexisting degenerative disease of the cervical spine.

I know what my chiropractic friends will respond to this post:

  • I am alarmist,
  • I cherry-pick articles that are negative for their profession,
  • these cases are extreme rarities,
  • conventional medicine is much more dangerous.

To this I reply: Imagine a conventional therapy about which the current Cochrane review says that it has no proven effect for the condition in question. Imagine further that this therapy causes mild to moderate adverse effects in about 50% of all patients in addition to very dramatic complications which are probably rare but, as no monitoring system exists, of unknown frequency. Imagine now that the professionals using this treatment more regularly than any other clinicians steadfastly deny that the risk/benefit balance is way out of kilter.

Would you call someone who repeatedly tries to warn the public of this situation ‘alarmist’?

Would you not consider the professionals who continue to practice the therapy in question to be irresponsible?

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