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

education

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One of the favourite arguments of proponents of so-called alternative medicine (SCAM) is that conventional medicine is amongst the world’s biggest killers. The argument is used cleverly to discredit conventional medicine and promote SCAM. It has been shown to be wrong many times, but it nevertheless is much-loved by SCAM enthusiasts and thus refuses to disappear. Perhaps this new and important review might help instilling some realism into this endless discussion? Here is its abstract:

Objective To systematically quantify the prevalence, severity, and nature of preventable patient harm across a range of medical settings globally.

Design Systematic review and meta-analysis.

Data sources Medline, PubMed, PsycINFO, Cinahl and Embase, WHOLIS, Google Scholar, and SIGLE from January 2000 to January 2019. The reference lists of eligible studies and other relevant systematic reviews were also searched.

Review methods Observational studies reporting preventable patient harm in medical care. The core outcomes were the prevalence, severity, and types of preventable patient harm reported as percentages and their 95% confidence intervals. Data extraction and critical appraisal were undertaken by two reviewers working independently. Random effects meta-analysis was employed followed by univariable and multivariable meta regression. Heterogeneity was quantified by using the I2 statistic, and publication bias was evaluated.

Results Of the 7313 records identified, 70 studies involving 337 025 patients were included in the meta-analysis. The pooled prevalence for preventable patient harm was 6% (95% confidence interval 5% to 7%). A pooled proportion of 12% (9% to 15%) of preventable patient harm was severe or led to death. Incidents related to drugs (25%, 95% confidence interval 16% to 34%) and other treatments (24%, 21% to 30%) accounted for the largest proportion of preventable patient harm. Compared with general hospitals (where most evidence originated), preventable patient harm was more prevalent in advanced specialties (intensive care or surgery; regression coefficient b=0.07, 95% confidence interval 0.04 to 0.10).

Conclusions Around one in 20 patients are exposed to preventable harm in medical care. Although a focus on preventable patient harm has been encouraged by the international patient safety policy agenda, there are limited quality improvement practices specifically targeting incidents of preventable patient harm rather than overall patient harm (preventable and non-preventable). Developing and implementing evidence-based mitigation strategies specifically targeting preventable patient harm could lead to major service quality improvements in medical care which could also be more cost effective.

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One in 20 patients is undoubtedly an unacceptably high proportion, but it is nowhere close to some of the extraordinarily alarming claims by SCAM enthusiasts. And, as I try regularly to remind people, the harm must be viewed in relation to the benefit. For the vast majority of conventional treatments, the benefits outweigh the risks. But, if there is no benefit at all – as with some form of SCAM – a risk/benefit balance can never be positive. Moreover, many experts work hard and do their very best to improve the risk/benefit balance of conventional healthcare by educating clinicians, maximising the benefits, minimising the risks, and filling the gaps in our current knowledge. Do equivalent activities exist in SCAM? The answer is VERY FEW?

Tian Jiu (TJ) therapy is a so-called alternative medicine (SCAM) that has been widely utilized in the management of allergic rhinitis (AR). TJ is also known as “drug moxibustion” or “vesiculating moxibustion.” Herbal patches are applied on the selected acupoints or the diseased body part. In TCM, this treatment is said to regulate the functions of meridians and zang-fu organs, warm the channels, disperse coldness, invigorate qi movement, harmonize nutrient absorption and defence mechanisms, and resolve stagnation in the body and stasis of the blood.

But does it work? This single-blinded, three-arm, randomized controlled study evaluated the efficacy of TJ therapy in AR. A total of 138 AR patients were enrolled. The TJ group and placebo group both received 4-weeks of treatment with either TJ or placebo patches for 2 hours. The patches were applied to Dazhui (GV 14), bilateral Feishu (UB 13), and bilateral Shenshu (UB 23) points. Patients received one session per week and then underwent a 4-week follow-up. The waitlist group received no treatment during the corresponding treatment period, but would be given compensatory TJ treatment in the next 4 weeks.

The primary outcome was the change of the Total Nasal Symptom Score (TNSS) after treatment. The secondary outcomes included the changes of Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) and rescue medication score (RMS).

After the treatment period, the total TNSS in TJ group was significantly reduced compared with baseline, but showed no statistical difference compared with placebo. Among the four domains of TNSS, the change of nasal obstruction exhibited statistical difference compared with placebo group. The total RQLQ score in TJ group was significantly reduced compared with both placebo and waitlist groups. The needs of rescue medications were not different between the two groups.

There were no serious adverse events. The common adverse events included flush, pruritus, blister, and pigmentation, occurring in 17, 23, 3, and 36 person-times among TJ group, and 3, 7, 1, and 4 person-times among placebo group, respectively. These adverse events were generally tolerated and disappeared quickly after removing the patches.

The authors (from the Hong Kong Chinese Medicine Clinical Study Centre, School of Chinese Medicine, Hong Kong Baptist University) concluded that this randomized, single-blinded, controlled trial served primary evidence of the efficacy and safety of TJ therapy on AR in Hong Kong. This pilot study provided a fundamental TJ protocol for future research. Through adjusting treatment timing, frequency, retention time, and even body response settings, it has the potential to develop into an optimal therapeutic method for future application.

The authors of this poorly written paper seem to ignore their own findings by concluding as they do. The fact is that the primary endpoint of this trial failed to show a significant difference between TJ and placebo. Moreover, TJ does have considerable adverse effects. Therefore, this study  fails to demonstrate both the effectiveness and the safety of TJ as a treatment of AR.

PS

I often hesitate whether or not to discuss the plethora such frightfully incompetent research. The reason I sometimes do it is to alert the public to the fact that so much utter rubbish is published by incompetent researchers in trashy (but Medline-listed) journals, passed by incompetent ethics committees, supported by naïve funding agencies, accepted by reviewers and editors who evidently do not do their job properly. Do all these people have forgotten that they have a responsibility towards the public?

It is time to stop this nonsense!

It gives a bad name to science, misleads the public and inhibits progress.

A new paper reminds us that so-called alternative medicine (SCAM) has been increasing in the United States and around the world, particularly at medical institutions known for providing rigorous evidence-based care. The use of SCAM may cause harm to patients through interactions with prescribed medications or by patients choosing to forego evidence-based care. SCAM may also put financial strain on patients as most SCAM expenditures are paid out-of-pocket.

Despite these drawbacks, patients continue to use SCAM due to a range of reasons, e.g. media promotion of SCAM therapies, dissatisfaction with conventional healthcare, a desire for more holistic care. Given the increasing demand for SCAM, many medical institutions now offer SCAM services. Several leaders of SCAM centres based at a highly respected academic medical institution have publicly expressed anti-vaccination views, and non-evidence-based philosophies run deep within SCAM.

Although there are financial incentives for institutions to provide SCAM, it is important to recognize that this legitimizes SCAM and may cause harm to patients. The poor regulation of SCAM allows for the continued distribution of products and services that have not been rigorously tested for safety and efficacy.

As I have tried to point out many times, the potential for harm caused by the increasing integration of SCAM can thus be summarised as follows:

  1. direct harm due to adverse effects such as toxicity of an herbal remedy, stroke after chiropractic manipulation, pneumothorax after acupuncture;
  2. direct harm through the use of bogus diagnostic techniques;
  3. direct harm by using materials from endangered species;
  4. indirect harm through incompetent advice such as recommendation not to immunize or discontinue prescribed medications;
  5. neglect due to using SCAM instead of an effective therapy for a serious condition;
  6. harm due to medicalising trivial states of reduced well-being;
  7. financial harm due to the costs of SCAM;
  8. harm through making a mockery of evidence-based medicine;
  9. harm caused by undermining rational thinking in the society at large;
  10. harm caused by inhibiting medical progress and research.

In case you see other ways in which SCAM can cause harm, please let me know by posting a comment.

‘Acute-on-chronic liver failure’ (ACLF) is an acute deterioration of liver function in patients with pre-existing liver disease. It is usually associated with a precipitating event and results in the failure of one or more organs and high short term mortality.

An international team of researchers published a analysis examining data regarding drugs producing ACLF. They evaluated clinical features, laboratory characteristics, outcome, and predictors of mortality in patients with drug-induced ACLF. They identified drugs as precipitants of ACLF among prospective cohort of patients with ACLF from the Asian Pacific Association of Study of Liver (APASL) ACLF Research Consortium (AARC) database. Drugs were considered precipitants after exclusion of known causes together with a temporal association between exposure and decompensation. Outcome was defined as death from decompensation.

Of the 3,132 patients with ACLF, drugs were implicated as a cause in 10.5% of all cases and other non-drug causes in 89.5%. Within the first group, so-called alternative medications (SCAMs) were the commonest cause (71.7%), followed by combination anti-tuberculosis therapy drugs (27.3%). Alcoholic liver disease (28.6%), cryptogenic liver disease (25.5%), and non-alcoholic steatohepatitis (NASH) (16.7%) were common causes of underlying liver diseases. Patients with drug-induced ACLF had jaundice (100%), ascites (88%), encephalopathy (46.5%), high Model for End-Stage Liver Disease (MELD) (30.2), and Child-Turcotte-Pugh score (12.1). The overall 90-day mortality was higher in drug-induced (46.5%) than in non-drug-induced ACLF (38.8%).

The authors concluded that drugs are important identifiable causes of ACLF in Asia-Pacific countries, predominantly from complementary and alternative medications, followed by anti-tuberculosis drugs. Encephalopathy, bilirubin, blood urea, lactate, and international normalized ratio (INR) predict mortality in drug-induced ACLF.

The fact that some SCAMs can damage the liver has long been known. Here, for example, is 2003 our review of herbal medicine and liver problems:

Systematic literature searches were performed on Medline, Embase, The Cochrane Library, Amed and Ciscom. To identify additional data, searches were conducted by hand in relevant medical journals and in our own files. The screening and selection of articles and the extraction of data were performed independently by the two authors. There were no restrictions regarding the language of publication. In order to be included articles were required to report data on hepatotoxic events associated with the therapeutic use of herbal medicinal products.

Single medicinal herbs and combination preparations are associated with hepatotoxic events. Clinically, the spectrum ranges from transient elevations of liver enzyme levels to fulminant liver failure and death. In most instances hepatotoxic herbal constituents are believed to be the cause, while others may be due to herb-drug interactions, contamination and/or adulteration.

A number of herbal medicinal products are associated with serious hepatotoxic events. Incidence figures are largely unknown, and in most cases a causal attribution is not established. The challenge for the future is to systematically research this area, educate all parties involved, and minimize patient risk.

Despite these warnings, progress is almost non-existent. If anything the problem seems to increase in proportion with the rise in the use of SCAM. Hence, one cannot but agree with the conclusion of a more recent overview: The actual incidence and prevalence of herb-induced liver injury in developing nations remain largely unknown due to both poor pharmacovigilance programs and non-application of emerging technologies. Improving education and public awareness of the potential risks of herbals and herbal products is desirable to ensure that suspected adverse effects are formally reported. There is need for stricter regulations and pre-clinical studies necessary for efficacy and safety.

My former institution, the medical school of Vienna, had invited me to give the key-note for a conference entitled ‘Esoterik in der Medizin‘ (22/5/2019). The event was to celebrate the success of a new course for medical students which was initiated after Prof Frass’ lectures on homeopathy had been discontinued. Remarkably, this move had been prompted by complaints from students arguing that Frass was promoting non-evidence-based, bogus concepts.

Whenever I go back to Vienna, I have mixed feelings; pleasant and not so pleasant memories (see below) come to the fore. This time, however, all turned out well, and I was more than delighted.

The new course signifies the realisation that so-called alternative medicine (SCAM) must be covered in any sound medical curriculum. Once graduated, students will be asked by patients about SCAM and have an ethical duty to inform them responsibly. Thus they need to know the essential facts and not the biased perspective that Frass and other enthusiasts tend to convey.

I have always considered this to be important but, as far as I can see, very few medical school manage to deal with this issue adequately. More often than not, the task of running such courses is given to proponents of SCAM who then try to brain-wash the unsuspecting students. The result can be seriously harmful to generations of patients. I am delighted to report that my former medical school has successfully avoided this pitfall. Quackademia has come to an end in Vienna!

In my view, the highlight of the recent event was the students’ presentation of their course-work. They had been supervised in small groups to research selected topics related to SCAM and were given 5 minute slots to present their findings. I truly felt this was impressive. The dedication, the quality of the research and the clarity of the presentations were extraordinary. In my 40 odd years of teaching medical students, I have never seen anything remotely similar (here I should mention perhaps that, 25 years ago when I was teaching in Vienna, medical students seemed to be as unmotivated as they get).

The students’ presentation were followed by 90 minutes of moderated discussion of the audience (the event was open to the public) and 4 experts. Here too, I was positively surprised by the quality of the contributions and the general openness of the debate.

So, overall the both the meeting and, more importantly, the new course for students can be considered a great success, and the organisers must be congratulated on it. For me personally, the most significant aspect was a matter entirely unrelated to SCAM. It was the introductory speech of the dean of the medical school. He announced me as the key-note speaker by praising my research on the Nazi history of the faculty. It was this research that, to some considerable degree, made me leave Vienna in 1993. To see it now appreciated by my former colleagues is deeply moving.

 

A pro-homeopathy site (to be taken with a pinch of salt) claims that today 300 homeopathic MDs belong to the “Unio Homoeopathica Belgica” and 4,000 MDs (about 10% of all doctors) are prescribing homeopathics at least occasionally.

See the source image

One-fourth of the Belgian population uses homeopathy. As of 1998, only MDs can legally practice homeopathy. But now it seems that the free ride for Belgian homeopathy is coming to an end. Belgium has joined the long list of countries (e.g. UK, US, Spain, France, Sweden, Russia) where the usefulness of homeopathy is being questioned.

‘Test Achats’ is a Belgian not-for-profit organization which promotes consumer protection. It was founded in 1957 and publishes research in a subscription magazine. It has been reported that this organiation has issued a crushing report on homoeopathy, describing it as “unacceptable” that homeopathic remedies are allowed to be described by practitioners as medication.

Il est inacceptable que des médicaments homéopathiques et des médicaments traditionnels à base de plantes puissent être vendus en tant que “médicament” en pharmacie sans que leur efficacité n’ait été démontrée. Il en va de même pour un certain nombre de médicaments classiques et de médicaments ordinaires à base de plantes, pour lesquels nous avons également de gros doutes quant à leur efficacité et/ou leur sécurité. Le statut de “médicament” leur confère une aura de crédibilité qu’ils ne méritent absolument pas. Notre banque de données de médicaments met un terme à cette tromperie et distingue les médicaments utiles de ceux qui ne le sont pas…

Pour les 55 médicaments homéopathiques avec indication, ces pourcentages sont … 84 % à “utilité contestable” et 16 % “à déconseiller”.

“The requirements of effectiveness, safety and quality to bring a product to market and be allowed to use the name of medication are sadly not the same for all products,” commented a spokesperson for Test-Achats. “Homeopathic products are required to be accompanied by a minimum of documentation, and the effectiveness of the product barely has to be proven.”

‘Test-Achats’ describes homoeopathy as “quack medicine,” and states that “there are conditions where the patient really has no time to lose on products whose effectiveness has not been demonstrated. People who are suffering from very real heart and vascular conditions should immediately seek treatment by a doctor, and with truly effective medication.”

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This is all very good news, I think.
It almost reads as though ‘Test Achat’ have discovered my blog.
Welcome!

One of the most difficult things in so-called alternative medicine (SCAM) can be having a productive discussion with patients about the subject, particularly if they are deeply pro-SCAM. The task can get more tricky, if a patient is suffering from a serious, potentially life-threatening condition. Arguably, the discussion would become even more difficult, if the SCAM in question is relatively harmless but supported only by scarce and flimsy evidence.

An example might be the case of a cancer patient who is fond of mindfulness cognitive therapy (MBCT), a class-based program designed to prevent relapse or recurrence of major depression. To contemplate such a situation, let’s consider the following hypothetical exchange between a patient (P) and her oncologist (O).

P: I often feel quite low, do you think I need some treatment for depression?

O: That depends on whether you are truly depressed or just a bit under the weather.

P: No, I am not clinically depressed; it’s just that I am worried and sometimes see everything in black.

O: I understand, that’s not an unusual thing in your situation.

P: Someone told me about MBCT, and I wonder what you think about it.

O: Yes, I happen to know about this approach, but I’m not sure it would help you.

P: Are you sure? A few years ago, I had some MBCT; it seemed to work and, at least, it cannot do any harm.

O: Yes, that’s true; MBCT is quite safe.

P: So, why are you against it?

O: I am not against it; I just doubt that it is the best treatment for you.

P: Why?

O: Because there is little evidence for it and even less for someone like you.

P: But I have seen some studies that seem to show it works.

O: I know, there have been trials but they are not very reliable.

P: But the therapy has not been shown to be ineffective, has it?

O: No, but the treatment is not really for your condition.

P: So, you admit that there is some positive evidence but you are still against it because of some technicalities with the science?

O: No, I am telling you that this treatment is not supported by good evidence.

P: And therefore you want me to continue to suffer from low mood? I don’t call that very compassionate!

O: I fully understand your situation, but we ought to find the best treatment for you, not just one that you happen to be fond of.

P: I don’t understand why you are against giving MBCT a try; it’s safe, as you say, and there is some evidence for it. And I have already had a good experience with it. Is that not enough?

O: My role as your doctor is to provide you with advice about which treatments are best in your particular situation. There are options that are much better than MBCT.

P: But if I want to try it?

O: If you want to try MBCT, I cannot prevent you from doing so. I am only trying to tell you about the evidence.

P: Fine, in this case, I will give it a go.

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Clearly this discussion did not go all that well. It was meant to highlight the tension between the aspirations of a patient and the hope of a responsible clinician to inform his patient about the best available evidence. Often the evidence is not in favour of SCAM. Thus there is a gap that can be difficult to breach. (Instead of using MBCT, I could, of course, have used dozens of other SCAMs like homeopathy, chiropractic, Reiki, etc.)

The pro-SCAM patient thinks that, as she previously has had a good experience with SCAM, it must be fine; at the very minimum, it should be tried again, and she wants her doctor to agree. The responsible clinician thinks that he ought to recommend a therapy that is evidence-based. The patient feels that scientific evidence tells her nothing about her experience. The clinician insists that evidence matters. The patient finds the clinician lacks compassion. The clinician feels that the most compassionate and ethical strategy is to recommend the most effective therapy.

As the discussion goes on, the gap is not closing but seems to be widening.

What can be done about it?

I wish I knew the answer!

Do you?

I have just given two lectures on so-called alternative medicine (SCAM) in France.

Why should that be anything to write home about?

Perhaps it isn’t; but during the last 25 years I have been lecturing all over the world and, even though I live partly in France and speak the language, I never attended a single SCAM-conference there. I have tried for a long time to establish contact with French SCAM-researchers, but somehow this never happened.

Eventually, I came to the conclusion that, although the practice of SCAM is hugely popular in this country, there was no or very little SCAM-research in France. This conclusion seems to be confirmed by simple Medline searches. For instance, Medline lists just 171 papers for ‘homeopathy/France’ (homeopathy is much-used in France), while the figures for Germany and the UK are 490 and 448.

These are, of course, only very rough indicators, and therefore I was delighted to be invited to participate for the first time in a French SCAM-conference. It was well-organised, and I am most grateful to the organisers to have me. Actually, the meeting was about non-pharmacological treatments but the focus was clearly on SCAM. Here are a few impressions purely on the SCAM-elements of this conference.

TERMINOLOGY

Already the title of the conference, ‘Non-pharmacological Interventions: Integrative, Preventive, Complementary and Personalised Medicines‘, contained a confusing shopping-list of terms. The actual lectures offered even more. Clear definitions of these terms were not forthcoming and are, as far as I can see, impossible. This meant that much of the discussion lacked focus. In both my presentations, I used the term ‘alternative medicine’ and stressed that all such umbrella terms are fairly useless. In my view, it is therefore best to name the precise modality (acupuncture, osteopathy, homeopathy etc.) one wants to discuss.

INTEGRATIVE MEDICINE

The term that seemed to dominate the conference was ‘INTEGRATIVE MEDICINE’ (IM). I got the impression that it was employed uncritically by some for bypassing the need for proper evaluation of any specific SCAM. The experts seemed to imply that, because IM is the politically and socially correct approach, there is no longer a need for asking whether the treatments to be integrated actually generate more good than harm. I got the impression that most of these researchers were confusing science with promotion.

RESEARCH METHODOLOGY

The discussions regularly touched upon research methodology – but they did little more than lightly touch it. People tended to lament that ‘conventional research methodology’ was inadequate for assessing SCAM, and that we therefore needed different methods and even paradigms. I did not hear any reasonable explanations in what respect the ‘conventional methodology’ might be insufficient, nor did I understand the concept of an alternative science or paradigm. My caution that double standards in medicine can only be detrimental, seemed to irritate and fell mostly on deaf ears.

RESEARCH QUESTIONS

My own research agenda has always been the efficacy and safety of SCAM; and I still have no doubt that these are the issues that need addressing more urgently than any others. My impression was that, during this conference, the researchers seemed to aim in entirely different directions. One speaker even explained that, if a homeopath is fully convinced of the assumptions of homeopathy, he is entirely within the ethical standards to treat his patients homeopathically, regardless of the fact that homeopathy is demonstrably wrong. Another speaker claimed that there is no doubt any longer about the efficacy of acupuncture; the research question therefore must be how to best implement it in routine healthcare. And yet another expert tried to explain TCM with quantum physics. I have, of course, heard similar nonsense before during such conferences, but rarely did it pass without objection or debate.

RESEARCH FUNDING

The lack of research funding was bemoaned repeatedly. Most researchers seemed to think that they needed dedicated funding streams for SCAM to take account of the need of softer methodologies and the unique nature of SCAM. The argument that there should be only one set of standards for spending scarce research funds – scientific rigor and relevance – was not one shared by the French SCAM enthusiasts. The US example was frequently cited as the one that we ought to follow. In my view, the US example foremost shows impressively that a ring-fenced funding stream for SCAM is a wasteful mistake.

THE COLLEGE

To my surprise I learnt during a conference presentation that there is such a thing as the ‘Collège Universitaire de Médecines Intégratives et Complémentaires‘ (How could I have been unaware of it all those years? Why did I never see any of their published work? Why did they never contact me and cooperate?). Its president is Prof Jacques Kopferschmitt from the University of Strasbourg, and many French Universities are members of this organisation. Here is the abstract of Kopferschmitt’s lecture on the topic of this College:

The multitude of complementary therapies or non-pharmacological interventions (NPIs) first requires pedagogical semantic harmonization to bring down the historical tensions that persist. If users often remain very or too seduced, it is not the same with health professionals! Behind the words, there are concepts that disturb because between efficiency and efficiency the nuances are subtle. However, nothing really stands in the way of modern western medicine, but there are really gaps that we could fill in the face of the growing scale of chronic diseases, the prerogative of the Western world. The need for a university investment in verification, validation and certification is essential in the face of the diversity of offers. The main beneficiaries are health professionals who need to invest in an integrative approach, particularly in France. The CUMIC promotes a different vision of efficiency and effectiveness with a broader vision of multidisciplinary evaluation, which we will discuss the main targets.

Kopferschmitt is Professor of Medical Therapy, which introduced him to a pluralism of approach to health concerns, including innovative by the introduction of the CT in the first and second cycle of medical studies. He is responsible for the teaching of Acupuncture, Auriculotherapy and hypnosis clinic. He is vice President of the Groupe d’Évaluation des Thérapies complémentaires Personnalisées (GETCOP). By founding the association of complementary Therapies at the University hospitals of Strasbourg he coordinates the introduction, teaching and research in both in Hospital and in University, who was organized many seminars on CT. He currently chairs the French University of Integrative and Complementary Medicine College (CUMIC).

This sounded odd to me; however, it got truly bizarre after I looked up what SCAM-research Kopferschmitt or any of the other officers of the College have published. I could not find a single SCAM-article authored by him/them.

DIFFERENT PLANET

Altogether I found the conference enjoyable and was pleased to meet many interesting and very kind people. But I often felt like having arrived on a different planet. Many of the discussions, lectures, ideas, comments, etc. reminded me of 1993, the year I had arrived in the UK to start our research in SCAM. What is more, I fear that French experts involved in real science might feel the same about those colleagues who seem to engage themselves in SCAM research with more enthusiasm than expertise, scientific rigour or track record. The planet I had landed on was one where critical thinking was yet to be discovered, I felt.

ADVICE

Who am I to teach others what to do?

Yes, I do hesitate to give advice – but, after all, I have researched SCAM for 25 years and published more on the subject that any researcher on the planet; and I too was once more of a SCAM-enthusiast as is apparent today. So, for what it’s worth, here is some hopefully constructive advice that crossed my mind while driving home through the beautiful French landscape:

  • Sort out the confusion in terminology and define your terms as accurately as you can.
  • Try to focus on the research questions that are justifiably the most important ones for improving healthcare.
  • Do not attempt to re-invent the wheel.
  • Once you have identified a truly relevant research question, read up what has already been published on it.
  • While doing this, differentiate between rigorous research and fluff that does not meet this criterion.
  • Remember to abandon your own prejudices; research is about finding the truth and not about confirming your beliefs.
  • Avoid double standards like the pest.
  • Publish your research in top journals and avoid SCAM-journals that nobody outside SCAM takes seriously.
  • If you do not have a track record of publishing articles in top journals, please do not pretend to be an expert.
  • Involve sceptics in discussions and projects.
  • Remember that criticism is a precondition of progress.

I sincerely hope that this advice is not taken the wrong way. I certainly do not mean to hurt anyone’s feelings. What I do want is foremost that my French colleagues don’t have to repeat all the mistakes we did in the UK and that they are able to make swift progress.

I am being told to educate myself and rethink the subject of NAPRAPATHY by the US naprapath Dr Charles Greer. Even though he is not very polite, he just might have a point:

Edzard, enough foolish so-called scientific, educated assesments from a trained Allopathic Physician. When asked, everything that involves Alternative Medicine in your eyesight is quackery. Fortunately, every Medically trained Allopathic Physician does not have your points of view. I have partnered with Orthopaedic Surgeons, Medical Pain Specialists, General practitioners, Thoracic Surgeons, Forensic Pathologists and Others during the course, whom appreciate the Services that Naprapaths provide. Many of my current patients are Medical Physicians. Educate yourself. Visit a Naprapath to learn first hand. I expect your outlook will certainly change.

I have to say, I am not normally bowled over by anyone who calls me an ‘allopath’ (does Greer not know that Hahnemann coined this term to denigrate his opponents? Is he perhaps also in favour of homeopathy?). But, never mind, perhaps I was indeed too harsh on naprapathy in my previous post on this subject.

So, let’s try again.

Just to remind you, naprapathy was developed by the chiropractor Oakley Smith who had graduated under D D Palmer in 1899. Smith was a former Iowa medical student who also had investigated Andrew Still’s osteopathy in Kirksville, before going to Palmer in Davenport. Eventually, Smith came to reject Palmer’s concept of vertebral subluxation and developed his own concept of “the connective tissue doctrine” or naprapathy.

Dr Geer published a short article explaining the nature of naprapathy:

Naprapathy- A scientific, Evidence based, integrative, Alternative form of Pain management and nutritional assessment that involves evaluation and treatment of Connective tissue abnormalities manifested in the entire human structure. This form of Therapeutic Regimen is unique specifically to the Naprapathic Profession. Doctors of Naprapathy, pronounced ( nuh-prop-a-thee) also referred to as Naprapaths or Neuromyologists, focus on the study of connective tissue and the negative factors affecting normal tissue. These factors may begin from external sources and latently produce cellular changes that in turn manifest themselves into structural impairments, such as irregular nerve function and muscular contractures, pulling its’ bony attachments out of proper alignment producing nerve irritability and impaired lymphatic drainage. These abnormalities will certainly produce a pain response as well as swelling and tissue congestion. Naprapaths, using their hands, are trained to evaluate tissue tension findings and formulate a very specific treatment regimen which produces positive results as may be evidenced in the patients we serve. Naprapaths also rely on information obtained from observation, hands on physical examination, soft tissue Palpatory assessment, orthopedic evaluation, neurological assessment linked with specific bony directional findings, blood and urinalysis laboratory findings, diet/ Nutritional assessment, Radiology test findings, and other pertinent clinical data whose information is scrutinized and developed into a individualized and specific treatment plan. The diagnostic findings and results produced reveal consistent facts and are totally irrefutable. The deductions that formulated these concepts of theory of Naprapathic Medicine are rationally believable, and have never suffered scientific contradiction. Discover Naprapathic Medicine, it works.

What interests me most here is that naprapathy is evidence-based. Did I perhaps miss something? As I cannot totally exclude this possibility, I did another Medline search. I found several trials:

1st study (2007)

Four hundred and nine patients with pain and disability in the back or neck lasting for at least 2 weeks, recruited at 2 large public companies in Sweden in 2005, were included in this randomized controlled trial. The 2 interventions were naprapathy, including spinal manipulation/mobilization, massage, and stretching (Index Group) and support and advice to stay active and how to cope with pain, according to the best scientific evidence available, provided by a physician (Control Group). Pain, disability, and perceived recovery were measured by questionnaires at baseline and after 3, 7, and 12 weeks.

RESULTS:

At 7-week and 12-week follow-ups, statistically significant differences between the groups were found in all outcomes favoring the Index Group. At 12-week follow-up, a higher proportion in the naprapathy group had improved regarding pain [risk difference (RD)=27%, 95% confidence interval (CI): 17-37], disability (RD=18%, 95% CI: 7-28), and perceived recovery (RD=44%, 95% CI: 35-53). Separate analysis of neck pain and back pain patients showed similar results.

DISCUSSION:

This trial suggests that combined manual therapy, like naprapathy, might be an alternative to consider for back and neck pain patients.

2nd study (2010)

Subjects with non-specific pain/disability in the back and/or neck lasting for at least two weeks (n = 409), recruited at public companies in Sweden, were included in this pragmatic randomized controlled trial. The two interventions compared were naprapathic manual therapy such as spinal manipulation/mobilization, massage and stretching, (Index Group), and advice to stay active and on how to cope with pain, provided by a physician (Control Group). Pain intensity, disability and health status were measured by questionnaires.

RESULTS:

89% completed the 26-week follow-up and 85% the 52-week follow-up. A higher proportion in the Index Group had a clinically important decrease in pain (risk difference (RD) = 21%, 95% CI: 10-30) and disability (RD = 11%, 95% CI: 4-22) at 26-week, as well as at 52-week follow-ups (pain: RD = 17%, 95% CI: 7-27 and disability: RD = 17%, 95% CI: 5-28). The differences between the groups in pain and disability considered over one year were statistically significant favoring naprapathy (p < or = 0.005). There were also significant differences in improvement in bodily pain and social function (subscales of SF-36 health status) favoring the Index Group.

CONCLUSIONS:

Combined manual therapy, like naprapathy, is effective in the short and in the long term, and might be considered for patients with non-specific back and/or neck pain.

3rd study (2016)

Participants were recruited among patients, ages 18-65, seeking care at the educational clinic of Naprapathögskolan – the Scandinavian College of Naprapathic Manual Medicine in Stockholm. The patients (n = 1057) were randomized to one of three treatment arms a) manual therapy (i.e. spinal manipulation, spinal mobilization, stretching and massage), b) manual therapy excluding spinal manipulation and c) manual therapy excluding stretching. The primary outcomes were minimal clinically important improvement in pain intensity and pain related disability. Treatments were provided by naprapath students in the seventh semester of eight total semesters. Generalized estimating equations and logistic regression were used to examine the association between the treatments and the outcomes.

RESULTS:

At 12 weeks follow-up, 64% had a minimal clinically important improvement in pain intensity and 42% in pain related disability. The corresponding chances to be improved at the 52 weeks follow-up were 58% and 40% respectively. No systematic differences in effect when excluding spinal manipulation and stretching respectively from the treatment were found over 1 year follow-up, concerning minimal clinically important improvement in pain intensity (p = 0.41) and pain related disability (p = 0.85) and perceived recovery (p = 0.98). Neither were there disparities in effect when male and female patients were analyzed separately.

CONCLUSION:

The effect of manual therapy for male and female patients seeking care for neck and/or back pain at an educational clinic is similar regardless if spinal manipulation or if stretching is excluded from the treatment option.

_________________________________________________________________

I don’t know about you, but I don’t call this ‘evidence-based’ – especially as all the three trials come from the same research group (no, not Greer; he seems to have not published at all on naprapathy). Dr Greer does clearly not agree with my assessment; on his website, he advertises treating the following conditions:

Anxiety
Back Disorders
Back Pain
Cervical Radiculopathy
Cervical Spondylolisthesis
Cervical Sprain
Cervicogenic Headache
Chronic Headache
Chronic Neck Pain
Cluster Headache
Cough Headache
Depressive Disorders
Fibromyalgia
Headache
Hip Arthritis
Hip Injury
Hip Muscle Strain
Hip Pain
Hip Sprain
Joint Clicking
Joint Pain
Joint Stiffness
Joint Swelling
Knee Injuries
Knee Ligament Injuries
Knee Sprain
Knee Tendinitis
Lower Back Injuries
Lumbar Herniated Disc
Lumbar Radiculopathy
Lumbar Spinal Stenosis
Lumbar Sprain
Muscle Diseases
Musculoskeletal Pain
Neck Pain
Sciatica (Not Due to Disc Displacement)
Sciatica (Not Due to Disc Displacement)
Shoulder Disorders
Shoulder Injuries
Shoulder Pain
Sports Injuries
Sports Injuries of the Knee
Stress
Tendonitis
Tennis Elbow (Lateral Epicondylitis)
Thoracic Disc Disorders
Thoracic Outlet Syndrome
Toe Injuries

Odd, I’d say! Did all this change my mind about naprapathy? Not really.

But nobody – except perhaps Dr Greer – can say I did not try.

And what light does this throw on Dr Greer and his professionalism? Since he seems to be already quite mad at me, I better let you answer this question.

So-called alternative medicine (SCAM) for animals is popular. A recent survey suggested that 76% of US dog and cat owners use some form of SCAM. Another survey showed that about one quarter of all US veterinary medical schools run educational programs in SCAM. Amazon currently offers more that 4000 books on the subject.

The range of SCAMs advocated for use in animals is huge and similar to that promoted for use in humans; the most commonly employed practices seem to include acupuncture, chiropractic, energy healing, homeopathy (as discussed in the previous post) and dietary supplements. In this article, I will briefly discuss the remaining 4 categories.

ACUPUNCTURE

Acupuncture is the insertion of needles at acupuncture points on the skin for therapeutic purposes. Many acupuncturists claim that, because it is over 2 000 years old, acupuncture has ‘stood the test of time’ and its long history proves acupuncture’s efficacy and safety. However, a long history of usage proves very little and might even just demonstrate that acupuncture is based on the pre-scientific myths that dominated our ancient past.

There are many different forms of acupuncture. Acupuncture points can allegedly be stimulated not just by inserting needles (the most common way) but also with heat, electrical currents, ultrasound, pressure, bee-stings, injections, light, colour, etc. Then there is body acupuncture, ear acupuncture and even tongue acupuncture. Traditional Chinese acupuncture is based on the Taoist philosophy of the balance between two life-forces, ‘yin and yang’. In contrast, medical acupuncturists tend to cite neurophysiological theories as to how acupuncture might work; even though some of these may appear plausible, they nevertheless are mere theories and constitute no proof for acupuncture’s validity.

The therapeutic claims made for acupuncture are legion. According to the traditional view, acupuncture is useful for virtually every condition. According to ‘Western’ acupuncturists, acupuncture is effective mostly for chronic pain. Acupuncture has, for instance, been used to improve mobility in dogs with musculoskeletal pain, to relieve pain associated with cervical neurological disease in dogs, for respiratory resuscitation of new-born kittens, and for treatment of certain immune-mediated disorders in small animals.

While the use of acupuncture seems to gain popularity, the evidence fails to support this. Our systematic review of acupuncture (to the best of my knowledge the only one on the subject) in animals included 14 randomized controlled trials and 17 non-randomized controlled studies. The methodologic quality of these trials was variable but, on average, it was low. For cutaneous pain and diarrhoea, encouraging evidence emerged that might warrant further investigation. Single studies reported some positive inter-group differences for spinal cord injury, Cushing’s syndrome, lung function, hepatitis, and rumen acidosis. However, these trials require independent replication. We concluded that, overall, there is no compelling evidence to recommend or reject acupuncture for any condition in domestic animals. Some encouraging data do exist that warrant further investigation in independent rigorous trials.

Serious complications of acupuncture are on record and have repeatedly been discussed on this blog: acupuncture needles can, for instance, injure vital organs like the lungs or the heart, and they can introduce infections into the body, e. g. hepatitis. About 100 human fatalities after acupuncture have been reported in the medical literature – a figure which, due to lack of a monitoring system, may disclose just the tip of an iceberg. Information on adverse effects of acupuncture in animals is currently not available.

Given that there is no good evidence that acupuncture works in animals, the risk/benefit balance of acupuncture cannot be positive.

CHIROPRACTIC

Chiropractic was created by D D Palmer (1845-1913), an American magnetic healer who, in 1895, manipulated the neck of a deaf janitor, allegedly curing his deafness. Chiropractic was initially promoted as a cure-all by Palmer who claimed that 95% of diseases were due to subluxations of spinal joints. Subluxations became the cornerstone of chiropractic ‘philosophy’, and chiropractors who adhere to Palmer’s gospel diagnose subluxation in nearly 100% of the population – even in individuals who are completely disease and symptom-free. Yet subluxations, as understood by chiropractors, do not exist.

There is no good evidence that chiropractic spinal manipulation might be effective for animals. A review of the evidence for different forms of manual therapies for managing acute or chronic pain syndromes in horses concluded that further research is needed to assess the efficacy of specific manual therapy techniques and their contribution to multimodal protocols for managing specific somatic pain conditions in horses. For other animal species or other health conditions, the evidence is even less convincing.

In humans, spinal manipulation is associated with serious complications (regularly discussed in previous posts), usually caused by neck manipulation damaging the vertebral artery resulting in a stroke and even death. Several hundred such cases have been documented in the medical literature – but, as there is no system in place to monitor such events, the true figure is almost certainly much larger. To the best of my knowledge, similar events have not been reported in animals.

Since there is no good evidence that chiropractic spinal manipulations work in animals, the risk/benefit balance of chiropractic fails to be positive.

ENERGY HEALING

Energy healing is an umbrella term for a range of paranormal healing practices, e. g. Reiki, Therapeutic Touch, Johrei healing, faith healing. Their common denominator is the belief in an ‘energy’ that can be used for therapeutic purposes. Forms of energy healing have existed in many ancient cultures. The ‘New Age’ movement has brought about a revival of these ideas, and today ‘energy’ healing systems are amongst the most popular alternative therapies in many countries.

Energy healing relies on the esoteric belief in some form of ‘energy’ which refers to some life force such as chi in Traditional Chinese Medicine, or prana in Ayurvedic medicine. Some proponents employ terminology from quantum physics and other ‘cutting-edge’ science to give their treatments a scientific flair which, upon closer scrutiny, turns out to be little more than a veneer of pseudo-science.

Considering its implausibility, energy healing has attracted a surprisingly high level of research activity in the form of clinical trials on human patients. Generally speaking, the methodologically best trials of energy healing fail to demonstrate that it generates effects beyond placebo. There are few studies of energy healing in animals, and those that are available are frequently less than rigorous (see for instance here and here). Overall, there is no good evidence to suggest that ‘energy’ healing is effective in animals.

Even though energy healing is per se harmless, it can do untold damage, not least because it can lead to neglect of effective treatments and it undermines rationality in our societies. Its risk/benefit balance therefore fails to be positive.

DIETARY SUPPLEMENTS

Dietary supplements for veterinary use form a category of remedies that, in most countries, is a regulatory grey area. Supplements can contain all sorts of ingredients, from minerals and vitamins to plants and synthetic substances. Therefore, generalisations across all types of supplements are impossible. The therapeutic claims that are being made for supplements are numerous and often unsubstantiated. Although they are usually promoted as natural and safe, dietary supplements do not have necessarily either of these qualities. For example, in the following situations, supplements can be harmful:

  1. Combining one supplement with another supplement or with prescribed medicines
  2. Substituting supplements for prescription medicines
  3. Overdosing some supplements, such as vitamin A, vitamin D, or iron

Examples of currently most popular supplements for use in animals include chondroitin, glucosamine, probiotics, vitamins, minerals, lutein, L-carnitine, taurine, amino acids, enzymes, St John’s wort, evening primrose oil, garlic and many other herbal remedies. For many supplements taken orally, the bioavailability might be low. There is a paucity of studies testing the efficacy of dietary supplements in animals. Three recent exceptions (all of which require independent replication) are:

Dietary supplements are promoted as being free of direct risks. On closer inspection, this notion turns out to be little more than an advertising slogan. As discussed repeatedly on this blog, some supplements contain toxic materials, contaminants or adulterants and thus have the potential to do harm. A report rightly concluded that many challenges stand in the way of determining whether or not animal dietary supplements are safe and at what dosage.  Supplements considered safe in humans and other cross-species are not always safe in horses, dogs, and cats.  An adverse event reporting system is badly needed.  And finally, regulations dealing with animal dietary supplements are in disarray.  Clear and precise regulations are needed to allow only safe dietary supplements on the market.

It is impossible to generalise about the risk/benefit balance of dietary supplements; however, caution is advisable.

CONCLUSION

SCAM for animals is an important subject, not least because of the current popularity of many treatments that fall under this umbrella. For most therapies, the evidence is woefully incomplete. This means that most SCAMs are unproven. Arguably, it is unethical to use unproven medicines in routine veterinary care.

 

 

 

PS

I was invited several months ago to write this article for VETERINARY RECORD. It was submitted to peer review and subsequently I withdrew my submission. The above post is a slightly revised version of the original (in which I used the term ‘alternative medicine’ rather than ‘SCAM’) which also included a section on homeopathy (see my previous post). The reason for the decision to withdraw this article was the following comment by the managing editor of VETERINARY RECORD:  A good number of vets use these therapies and a more balanced view that still sets out their efficacy (or otherwise) would be more useful for the readership.

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