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

risk

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A new update of the current Cochrane review assessed the benefits and harms of spinal manipulative therapy (SMT) for the treatment of chronic low back pain. The authors included all randomised controlled trials (RCTs) examining the effect of spinal manipulation or mobilisation in adults (≥18 years) with chronic low back pain with or without referred pain. Studies that exclusively examined sciatica were excluded.

The effect of SMT was compared with recommended therapies, non-recommended therapies, sham (placebo) SMT, and SMT as an adjuvant therapy. Main outcomes were pain and back specific functional status, examined as mean differences and standardised mean differences (SMD), respectively. Outcomes were examined at 1, 6, and 12 months.

Forty-seven RCTs including a total of 9211 participants were identified. Most trials compared SMT with recommended therapies. In 16 RCTs, the therapists were chiropractors, in 14 they were physiotherapists, and in 5 they were osteopaths. They used high velocity manipulations in 18 RCTs, low velocity manipulations in 12 studies and a combination of the two in 20 trials.

Moderate quality evidence suggested that SMT has similar effects to other recommended therapies for short term pain relief and a small, clinically better improvement in function. High quality evidence suggested that, compared with non-recommended therapies, SMT results in small, not clinically better effects for short term pain relief and small to moderate clinically better improvement in function.

In general, these results were similar for the intermediate and long term outcomes as were the effects of SMT as an adjuvant therapy.

Low quality evidence suggested that SMT does not result in a statistically better effect than sham SMT at one month. Additionally, very low quality evidence suggested that SMT does not result in a statistically better effect than sham SMT at six and 12 months. Low quality evidence suggested that SMT results in a moderate to strong statistically significant and clinically better effect than sham SMT at one month. Additionally, very low quality evidence suggested that SMT does not result in a statistically significant better effect than sham SMT at six and 12 months.

(Mean difference in reduction of pain at 1, 3, 6, and 12 months (0-100; 0=no pain, 100 maximum pain) for spinal manipulative therapy (SMT) versus recommended therapies in review of the effects of SMT for chronic low back pain. Pooled mean differences calculated by DerSimonian-Laird random effects model.)

About half of the studies examined adverse and serious adverse events, but in most of these it was unclear how and whether these events were registered systematically. Most of the observed adverse events were musculoskeletal related, transient in nature, and of mild to moderate severity. One study with a low risk of selection bias and powered to examine risk (n=183) found no increased risk of an adverse event or duration of the event compared with sham SMT. In one study, the Data Safety Monitoring Board judged one serious adverse event to be possibly related to SMT.

The authors concluded that SMT produces similar effects to recommended therapies for chronic low back pain, whereas SMT seems to be better than non-recommended interventions for improvement in function in the short term. Clinicians should inform their patients of the potential risks of adverse events associated with SMT.

This paper is currently being celebrated (mostly) by chiropractors who think that it vindicates their treatments as being both effective and safe. However, I am not sure that this is entirely true. Here are a few reasons for my scepticism:

  • SMT is as good as other recommended treatments for back problems – this may be so but, as no good treatment for back pain has yet been found, this really means is that SMT is as BAD as other recommended therapies.
  • If we have a handful of equally good/bad treatments, it stand to reason that we must use other criteria to identify the one that is best suited – criteria like safety and cost. If we do that, it becomes very clear that SMT cannot be named as the treatment of choice.
  • Less than half the RCTs reported adverse effects. This means that these studies were violating ethical standards of publication. I do not see how we can trust such deeply flawed trials.
  • Any adverse effects of SMT were minor, restricted to the short term and mainly centred on musculoskeletal effects such as soreness and stiffness – this is how some naïve chiro-promoters already comment on the findings of this review. In view of the fact that more than half the studies ‘forgot’ to report adverse events and that two serious adverse events did occur, this is a misleading and potentially dangerous statement and a good example how, in the world of chiropractic, research is often mistaken for marketing.
  • Less than half of the studies (45% (n=21/47)) used both an adequate sequence generation and an adequate allocation procedure.
  • Only 5 studies (10% (n=5/47)) attempted to blind patients to the assigned intervention by providing a sham treatment, while in one study it was unclear.
  • Only about half of the studies (57% (n=27/47)) provided an adequate overview of withdrawals or drop-outs and kept these to a minimum.
  • Crucially, this review produced no good evidence to show that SMT has effects beyond placebo. This means the modest effects emerging from some trials can be explained by being due to placebo.
  • The lead author of this review (SMR), a chiropractor, does not seem to be free of important conflicts of interest: SMR received personal grants from the European Chiropractors’ Union (ECU), the European Centre for Chiropractic Research Excellence (ECCRE), the Belgian Chiropractic Association (BVC) and the Netherlands Chiropractic Association (NCA) for his position at the Vrije Universiteit Amsterdam. He also received funding for a research project on chiropractic care for the elderly from the European Centre for Chiropractic Research and Excellence (ECCRE).
  • The second author (AdeZ) who also is a chiropractor received a grant from the European Chiropractors’ Union (ECU), for an independent study on the effects of SMT.

After carefully considering the new review, my conclusion is the same as stated often before: SMT is not supported by convincing evidence for back (or other) problems and does not qualify as the treatment of choice.

I stared my Exeter post in October 1993. It took the best part of a year to set up a research team, find rooms etc. So, our research began in earnest only mid 1994. From the very outset, it was clear to me that investigating the risks of so-called alternative medicine (SCAM) should be our priority. The reason, I felt, was simple: SCAM was being used a million times every day; therefore it was an ethical imperative to check whether these treatments were as really safe as most people seemed to believe.

In the course of this line of investigation, we did discover many surprises (and lost many friends). One of the very first revelation was that homeopathy might not be harmless. Our initial results on this topic were published in this 1995 article. In view of the still ongoing debate about homeopathy, I’d like to re-publish the short paper here:

Homoeopathic remedies are believed by doctors and patients to be almost totally safe. Is homoeopathic advice safe, for example on the subject of immunization? In order to answer this question, a questionnaire survey was undertaken in 1995 of all 45 homoeopaths listed in the Exeter ‘yellow pages’ business directory. A total of 23 replies (51%) were received, 10 from medically qualified and 13 from non-medically qualified homoeopaths.

The homoeopaths were asked to suggest which conditions they perceived as being most responsive to homoeopathy. The three most frequently cited conditions were allergies (suggested by 10 respondents), gynaecological problems (seven) and bowel problems (five).

They were then asked to estimate the proportion of patients that were referred to them by orthodox doctors and the proportion that they referred to orthodox doctors. The mean estimated percentages were 1 % and 8%, respectively. The 23 respondents estimated that they spent a mean of 73 minutes on the first consultation.

The homoeopaths were asked whether they used or recommended orthodox immunization for children and whether they only used and recommended homoeopathic immunization. Seven of the 10 homoeopaths who were medically qualified recommended orthodox immunization but none of the 13 non-medically qualified homoeopaths did. One non-medically qualified homoeopath only used and recommended homoeopathic immunization.

Homoeopaths have been reported as being against orthodox immunization’ and advocating homoeopathic immunization for which no evidence of effectiveness exists. As yet there has been no attempt in the United Kingdom to monitor homoeopaths’ attitudes in this respect. The above findings imply that there may be a problem. The British homoeopathic doctors’ organization (the Faculty of Homoeopathy) has distanced itself from the polemic of other homoeopaths against orthodox immunization, and editorials in the British Homoeopathic Journal call the abandonment of mass immunization ‘criminally irresponsible’ and ‘most unfortunate, in that it will be seen by most people as irresponsible and poorly based’.’

Homoeopathic remedies may be safe, but do all homoeopaths merit this attribute?

This tiny and seemingly insignificant piece of research triggered debate and research (my group must have published well over 100 papers in the years that followed) that continue to the present day. The debate has spread to many other countries and now involves numerous forms of SCAM other than just homeopathy. It relates to many complex issues such as the competence of SCAM practitioners, their ethical standards, education, regulation, trustworthiness and the risk of neglect.

Looking back, it feels odd that, at least for me, all this started with such a humble investigation almost a quarter of a century ago. Looking towards the future, I predict that we have so far merely seen the tip of the iceberg. The investigation of the risks of SCAM has finally started in earnest and will, I am sure, continue thus leading to a better protection of patients and consumers from charlatans and their bogus claims.

We have discussed the diagnostic methods used by practitioners of alternative medicine several times before (see for instance here, here, here, here, here and here). Now a new article has been published which sheds more light on this important issue.

The authors point out that the so-called alternative medicine (SCAM) community promote and sell a wide range of tests, many of which are of dubious clinical significance. Many have little or no clinical utility and have been widely discredited, whilst others are established tests that are used for unvalidated purposes.

  1. The paper mentions the 4 key factors for evaluation of diagnostic methods:
    Analytic validity of a test defines its ability to measure accurately and reliably the component of interest. Relevant parameters include analytical accuracy and precision, susceptibility to interferences and quality assurance.
  2. Clinical validity defines the ability to detect or predict the presence or absence of an accepted clinical disease or predisposition to such a disease. Relevant parameters include sensitivity, specificity, and an understanding of how these parameters change in different populations.
  3. Clinical utility refers to the likelihood that the test will lead to an improved outcome. What is the value of the information to the individual being tested and/or to the broader population?
  4. Ethical, legal and social implications (ELSI) of a test. Issues include how the test is promoted, how the reasons for testing are explained to the patient, the incidence of false-positive results and incorrect diagnoses, the potential for unnecessary treatment and the cost-effectiveness of testing.

The tests used by  SCAM-practitioners range from the highly complex, employing state of the art technology, e.g. heavy metal analysis using inductively coupled plasma-mass spectrometry, to the rudimentary, e.g. live blood cell analysis. Results of ‘SCAM tests’ are often accompanied by extensive clinical interpretations which may recommend, or be used to justify, unnecessary or harmful treatments. There are now a small number of laboratories across the globe that specialize in SCAM testing. Some SCAM laboratories operate completely outside of any accreditation programme whilst others are fully accredited to the standard of established clinical laboratories.

In their review, the authors explore SCAM testing in the United States, the United Kingdom and Australia with a focus on the common tests on offer, how they are reported, the evidence base for their clinical application and the regulations governing their use. They also review proposed changed to in-vitro diagnostic device regulations and how these might impact on SCAM testing.

The authors conclude hat the common factor in all these tests is the lack of evidence for clinical validity and utility as used in SCAM practice. This should not be surprising since this is true for SCAM practice in general. Once there is a sound evidence base for an intervention, such as a laboratory test, then it generally becomes incorporated into conventional medical practice.

The paper also discusses possible reasons why SCAM-tests are appealing:

  • Adding an element of science to the consultation. Patients know that conventional medicine relies heavily on laboratory diagnostics. If the SCAM practitioner orders laboratory tests, the patient may feel they are benefiting from a scientific approach.
  • Producing material diagnostic data to support a diagnosis. SCAM lab reports are well presented in a format that is attractive to patients adding legitimacy to a diagnosis. Tests are often ordered as large profiles of multiple analytes. It follows that this will increase the probability of getting results outside of a given reference interval purely by chance. ‘Abnormal’ results give the SCAM practitioner something to build a narrative around if clinical findings are unclear. This is particularly relevant for patients who have chronic conditions, such as CFS or fibromyalgia where a definitive cause has not been established and treatment options are limited.
  • Generating business opportunities using abnormal results. Some practitioners may use abnormal laboratory results to justify further testing, supplements or therapies that they can offer.
  • By offering tests that are not available through traditional healthcare services some SCAM practitioners may claim they are offering a unique specialist service that their doctor is unable to provide. This can be particularly appealing to patients with unexplained symptoms for which there are a limited range of evidenced-based investigations and treatments available.

Regulation of SCAM laboratory testing is clearly deficient, the authors of this paper conclude. Where SCAM testing is regulated at all, regulatory authorities primarily evaluate analytical validity of the tests a laboratory offers. Clinical validity and clinical utility are either not evaluated adequately or not evaluated at all and the ethical, legal and social implications of a test may only be considered on a reactive basis when consumers complain about how tests are advertised.

I have always thought that the issue of SCAM tests is hugely important; yet it remains much-neglected. A rubbish diagnosis is likely to result in a rubbish treatment. Unreliable diagnostic methods lead to false-positive and false-negative diagnoses. Both harm the patient. In 1995, I thus published a review that concluded with this warning “alternative” diagnostic methods may seriously threaten the safety and health of patients submitted to them. Orthodox doctors should be aware of the problem and inform their patients accordingly.

Sadly, my warning has so far had no effect whatsoever.

I hope this new paper is more successful.

Collagen is a fibrillar protein of the conjunctive and connective tissues in the human body, essentially skin, joints, and bones. Due to its abundance in our bodies, its strength and its relation with skin aging, collagen has gained great interest as an oral dietary supplement as well as an ingredient in cosmetics. Collagen fibres get damaged with the pass of time, losing thickness and strength which has been linked to skin aging phenomena. Collagen can be obtained from natural sources such as plants and animals or by recombinant protein production systems. Because of its increased use, the collagen market is worth billions. The question therefore arises: is it worth it?

This 2019 systematic review assessed all available randomized-controlled trials using collagen supplementation for treatment efficacy regarding skin quality, anti-aging benefits, and potential application in medical dermatology. Eleven studies with a total of 805 patients were included. Eight studies used collagen hydrolysate, 2.5g/d to 10g/d, for 8 to 24 weeks, for the treatment of pressure ulcers, xerosis, skin aging, and cellulite. Two studies used collagen tripeptide, 3g/d for 4 to 12 weeks, with notable improvement in skin elasticity and hydration. Lastly, one study using collagen dipeptide suggested anti-aging efficacy is proportionate to collagen dipeptide content.

The authors concluded that preliminary results are promising for the short and long-term use of oral collagen supplements for wound healing and skin aging. Oral collagen supplements also increase skin elasticity, hydration, and dermal collagen density. Collagen supplementation is generally safe with no reported adverse events. Further studies are needed to elucidate medical use in skin barrier diseases such as atopic dermatitis and to determine optimal dosing regimens.

These conclusions are similar to those of a similar but smaller review of 2015 which concluded that the oral supplementation with collagen peptides is efficacious to improve hallmarks of skin aging.

And what about the many other claims that are currently being made for oral collagen?

A 2006 review of collagen for osteoarthritis concluded that a growing body of evidence provides a rationale for the use of collagen hydrolysate for patients with OA. It is hoped that ongoing and future research will clarify how collagen hydrolysate provides its clinical effects and determine which populations are most appropriate for treatment with this supplement. For other indication, the evidence seems less conclusive.

So, what should we make of this collective evidence. My interpretation is that, of course, there are caveats. For instance, most studies are small and not as rigorous as one would hope. But the existing evidence is nevertheless intriguing (and much more compelling than that for most other supplements). Moreover, there seem to be very few adverse effects with oral usage (don’t inject the stuff for cosmetic purposes, as often recommended!). Therefore, I feel that collagen might be one of the few dietary supplements worth keeping an eye on.

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.

Determined to cover as many so-called alternative medicines (SCAMs) as I possibly can, I was intrigued to see an article in the EVENING STANDARD about a SCAM I had not been familiar with: YANG SHENG.

Here is an excerpt of this article:

When people meet Katie Brindle, they usually ask whether she does acupuncture. “In fact, I specialise in yang sheng,” she says, a sigh in her voice. “It’s a massive aspect of Chinese medicine that no one knows anything about.” She’s on a mission to change that. Yang sheng is, in simplest terms, “prevention not cure” and Brindle puts it into practice with Hayo’u, her part-beauty brand, part-wellness programme, which draws on rituals in Far Eastern medicine. The “Reset” ritual, for example, is based on the Chinese martial art of qigong and involves shaking, drumming and twisting the body to wake up your circulation — Brindle says it stimulates digestion and boosts immunity. The “Body Restorer”, a gentle massage of the neck, chest and back, has a history of being used as a form of treatment for fever, muscle pain, inflammation and migraines. The principle underpinning all the practices is that small changes in your daily routine can help prevent your body from illness. Brindle wants it to be accessible: the website is free, and she is planning Facebook live-streams later in the year. There will also be a book in April, focusing on prevention rather than cure…

Frustrated about the overtly adversorial nature of this article, I did a few searches (not made easy by the fact that Yang and Sheng are common names of authors and yangsheng is the name of an acupuncture point) and found that Yang Sheng is said to be a health-promoting method in Traditional Chinese Medicine (TCM) that includes movement, mental exercise, and breathing technique. It is used mainly in China but has apparently it is currently enjoying an ever-widening acceptance in the Western world as well.

Is there any evidence for it?

Good question!

A paper from 1998 reported an observational study with 30 asthma patients, with varying degrees of illness severity. They were taught Qigong Yangsheng under medical supervision and asked to exercise independently, if possible, on a daily basis. They kept a diary of their symptoms for half a year including peak-flow measurements three times daily, use of medication, frequency and length of exercise as well as five asthma-relevant symptoms (sleeping through the night, coughing, expectoration, dyspnea, and general well-being). A decrease of at least 10 percent in peak-flow variability between the 1st and the 52nd week occurred more frequently in the group of the exercisers (n = 17) than in the group of non-exercisers (n = 13). When comparing the study year with the year before the study, there was improvement also in reduced hospitalization rate, less sickness leave, reduced antibiotic use and fewer emergency consultations resulting in reduced treatment costs. The authors concluded that Qigong Yangsheng is recommended for asthma patients with professional supervision. An improvement in airway capability and a decrease in illness severity can be achieved by regular self-conducted Qigong exercises.

The flaws of this study are obvious, and I don’t even bother to criticise it here.

Unfortunately, that was the only ‘study’ I found.

I also located many websites most of which are all but useless. Here is one that offers some explanations:

Yang sheng is a self-care approach. What makes this any different from all those other wellbeing manuals? The short answer is, that this is advice rooted in thousands of years of wisdom. Texts on how to preserve and extend life, health and wellbeing have been part of the Chinese tradition since the 4thcentury BC. They’ve had over 25 centuries to be refined and are time tested.

Yang sheng takes into account core theories like yin and yang, adhering to the laws of nature and harmonious free flow of Qi around the body (see below). As the active pursuit of the best possible functioning and balance of the whole self – body, mind and spirit. Yang Sheng takes into consideration your relationships to people and the environment.

In the West, we systematically neglect wellness and disease prevention. We take our good health for granted. We assume that we cannot avoid disease. And then when we are ill, we treat the symptoms of disease rather than finding the root cause.

Yang Sheng is about discovering energy imbalances long before they turn into overt disease. It works on the approach of eliminating small health niggles and balancing the body to stay healthy.

If this sounds like a conspiracy of BS to you, I would not blame you.

So, what can we conclude from this? I think, it is fair to say that:

  • Yang Sheng is being promoted as yet another TCM miracle.
  • It is based on all the obsolete nonsense that TCM has to offer.
  • Numerous therapeutic and preventative claims are being made for it.
  • None of them is supported by anything resembling good evidence.
  • Anyone with a serious condition who trusts Yang Sheng advocates puts her/his life in danger.
  • The EVENING STANDARD is not a source for reliable medical information.

I don’t expect many of my readers to be surprised, concerned or alarmed by any of this. In my view, however, this lack of alarm is exactly what is alarming! We have become so used to seeing bogus claims and dangerous BS in the realm of SCAM that abnormality has gradually turned into something close to normality.

I find the type of normality that incessantly misleads consumers and endangers patients quite simply unacceptable.

The Journal of Experimental Therapeutics and Oncology states that it is devoted to the rapid publication of innovative preclinical investigations on therapeutic agents against cancer and pertinent findings of experimental and clinical oncology. In the journal you will find review articles, original articles, and short communications on all areas of cancer research, including but not limited to preclinical experimental therapeutics; anticancer drug development; cancer biochemistry; biotechnology; carcinogenesis; cancer cytogenetics; clinical oncology; cytokine biology; epidemiology; molecular biology; pathology; pharmacology; tumor cell biology; and experimental oncology.

After reading an article entitled ‘How homeopathic medicine works in cancer treatment: deep insight from clinical to experimental studies’ in its latest issue, I doubt that the journal is devoted to anything.

Here is the abstract:

In the current scenario of medical sciences, homeopathy, the most popular system of therapy, is recognized as one of the components of complementary and alternative medicine (CAM) across the world. Despite, a long debate is continuing whether homeopathy is just a placebo or more than it, homeopathy has been considered to be safe and cost-effectiveness therapeutic modality. A number of human ailments ranging from common to serious have been treated with homeopathy. However, selection of appropriate medicines against a disease is cumbersome task as total spectrum of symptoms of a patient guides this process. Available data suggest that homeopathy has potency not only to treat various types of cancers but also to reduce the side effects caused by standard therapeutic modalities like chemotherapy, radiotherapy or surgery. Although homeopathy has been widely used for management of cancers, its efficacy is still under question. In the present review, the anti-cancer effect of various homeopathic drugs against different kinds of cancers has been discussed and future course of action has also been suggested.

I do wonder what possessed the reviewers of this paper and the editors of the journal to allow such dangerous (and badly written) rubbish to get published. Do they not know that:

  1. homeopathy is a placebo therapy,
  2. homeopathy can not cure any cancer,
  3. cancer patients are highly vulnerable to false hope,
  4. such an article endangers the lives of many cancer patients,
  5. they have an ethical, moral and possibly legal duty to prevent such mistakes?

What makes this paper even more upsetting is the fact that one of its authors is affiliated with the Department of Health Research, Ministry of Health and Family Welfare, Government of India.

Family welfare my foot!

This certainly is one of the worst violations of healthcare and publication ethic that I have come across for a long time.

 

Robert Verkerk, Executive & scientific director, Alliance for Natural Health (ANH), seems to adore me (maybe that’s why I kept this post for Valentine’s Day?). In 2006, he published this article about me (it is lengthy, and I therefore shortened a bit, but feel free to study it in its full beauty):

START OF QUOTE

PROFESSOR EDZARD ERNST, the UK’s first professor of complementary medicine, gets lots of exposure for his often overtly negative views on complementary medicine. He’s become the media’s favourite resource for a view on this controversial subject…

The interesting thing about Prof Ernst is that he seems to have come a long way from his humble beginnings as a recipient of the therapies that he now seems so critical of. Profiled by Geoff Watts in the British Medical Journal, the Prof tells us: ‘Our family doctor in the little village outside Munich where I grew up was a homoeopath. My mother swore by it. As a kid I was treated homoeopathically. So this kind of medicine just came naturally. Even during my studies I pursued other things like massage therapy and acupuncture. As a young doctor I had an appointment in a homeopathic hospital, and I was very impressed with its success rate. My boss told me that much of this success came from discontinuing main stream medication. This made a big impression on me.’ (BMJ Career Focus 2003; 327:166; doi:10.1136/bmj.327.7425.s166)…

After his early support for homeopathy, Professor Ernst has now become, de facto, one of its main opponents. Robin McKie, science editor for The Observer (December 18, 2005) reported Ernst as saying, ‘Homeopathic remedies don’t work. Study after study has shown it is simply the purest form of placebo. You may as well take a glass of water than a homeopathic medicine.’ Ernst, having done the proverbial 180 degree turn, has decided to stand firmly shoulder to shoulder with a number of other leading assailants of non-pharmaceutical therapies, such as Professors Michael Baum and Jonathan Waxman. On 22 May 2006, Baum and twelve other mainly retired surgeons, including Ernst himself, bandied together and co-signed an open letter, published in The Times, which condemned the NHS decision to include increasing numbers of complementary therapies…

As high profile as the Ernsts, Baums and Waxmans of this world might be—their views are not unanimous across the orthodox medical profession. Some of these contrary views were expressed just last Sunday in The Sunday Times (Lost in the cancer maze, 10 December 2006)…

The real loser in open battles between warring factions in healthcare could be the consumer. Imagine how schizophrenic you could become after reading any one of the many newspapers that contains both pro-natural therapy articles and stinging attacks like that found in this week’s Daily Mail. But then again, we may misjudge the consumer who is well known for his or her ability to vote with the feet—regardless. The consumer, just like Robert Sandall, and the millions around the world who continue to indulge in complementary therapies, will ultimately make choices that work for them. ‘Survival of the fittest’ could provide an explanation for why hostile attacks from the orthodox medical community, the media and over-zealous regulators have not dented the steady increase in the popularity of alternative medicine.

Although we live in a technocratic age where we’ve handed so much decision making to the specialists, perhaps this is one area where the might of the individual will reign. Maybe the disillusionment many feel for pharmaceutically-biased healthcare is beginning to kick in. Perhaps the dictates from the white coats will be overruled by the ever-powerful survival instinct and our need to stay in touch with nature, from which we’ve evolved.

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Elsewhere, Robert Verkerk even called me the ‘master trickster of evidence-based medicine’ and stated that Prof Ernst and his colleagues appear to be evaluating the ‘wrong’ variable. As Ernst himself admitted, his team are focused on exploring only one of the variables, the ‘specific therapeutic effect’ (Figs 1 and 2). It is apparent, however, that the outcome that is of much greater consequence to healthcare is the combined effect of all variables, referred to by Ernst as the ‘total effect’ (Fig 1). Ernst does not appear to acknowledge that the sum of these effects might differ greatly between experimental and non-experimental situations.

Adding insult to injury, Ernst’s next major apparent faux pas involves his interpretation, or misinterpretation, of results. These fundamental problems exist within a very significant body of Prof Ernst’s work, particularly that which has been most widely publicised because it is so antagonistic towards healing cultures that have in many cases existed and evolved over thousands of years.

By example, a recent ‘systematic review’ of individualised herbal medicine undertaken by Ernst and colleagues started with 1345 peer-reviewed studies. However, all but three (0.2%) of the studies (RCTs) were rejected. These three RCTs in turn each involved very specific types of herbal treatment, targeting patients with IBS, knee osteoarthritis and cancer, the latter also undergoing chemotherapy, respectively. The conclusions of the study, which fuelled negative media worldwide, disconcertingly extended well beyond the remit of the study or its results. An extract follows: “Individualised herbal medicine, as practised in European medical herbalism, Chinese herbal medicine and Ayurvedic herbal medicine, has a very sparse evidence base and there is no convincing evidence that it is effective in any [our emphasis] indication. Because of the high potential for adverse events and negative herb-herb and herb-drug interactions, this lack of evidence for effectiveness means that its use cannot be recommended (Postgrad Med J 2007; 83: 633-637).

Robert Verkerk has recently come to my attention again – as the main author of a lengthy report published in December 2018. Its ‘Executive Summary’ makes the following points relevant in the context of this blog (the numbers in his text were added by me and refer to my comments below):

  • This position paper proposes a universal framework, based on ecological and sustainability principles, aimed at allowing qualified health professionals (1), regardless of their respective modalities (disciplines), to work collaboratively and with full participation of the public in efforts to maintain or regenerate health and wellbeing. Accordingly, rather than offering ‘fixes’ for the NHS, the paper offers an approach that may significantly reduce the NHS’s current and growing disease burden that is set to reach crisis point given current levels of demand and funding.
  • A major factor driving the relentlessly rising costs of the NHS is its over-reliance on pharmaceuticals (2) to treat a variety of preventable, chronic disorders. These (3) are the result — not of infection or trauma — but rather of our 21st century lifestyles, to which the human body is not well adapted. The failure of pharmaceutically-based approaches to slow down, let alone reverse, the dual burden of obesity and type 2 diabetes means wider roll-out of effective multi-factorial approaches are desperately needed (4).
  • The NHS was created at a time when infectious diseases were the biggest killers (5). This is no longer the case, which is why the NHS must become part of a wider system that facilitates health regeneration or maintenance. The paper describes the major mechanisms underlying these chronic metabolic diseases, which are claiming an increasingly large portion of NHS funding. It identifies 12 domains of human health, many of which are routinely thrown out of balance by our contemporary lifestyles. The most effective way of treating lifestyle disorders is with appropriate lifestyle changes that are tailored to individuals, their needs and their circumstances. Such approaches, if appropriately supported and guided, tend to be far more economical and more sustainable as a means of maintaining or restoring people’s health (6).
  • A sustainable health system, as proposed in this position paper, is one in which the individual becomes much more responsible for maintaining his or her own health and where more effort is invested earlier in an individual’s life prior to the downstream manifestation of chronic, degenerative and preventable diseases (7). Substantially more education, support and guidance than is typically available in the NHS today will need to be provided by health professionals (1), informed as necessary by a range of markers and diagnostic techniques (8). Healthy dietary and lifestyle choices and behaviours (9) are most effective when imparted early, prior to symptoms of chronic diseases becoming evident and before additional diseases or disorders (comorbidities) have become deeply embedded.
  • The timing of the position paper’s release coincides not only with a time when the NHS is in crisis, but also when the UK is deep in negotiations over its extraction from the European Union (EU). The paper includes the identification of EU laws that are incompatible with sustainable health systems, that the UK would do well to reject when the time comes to re-consider the British statute books following the implementation of the Great Repeal Bill (10).
  • This paper represents the first comprehensive attempt to apply sustainability principles to the management of human health in the context of our current understanding of human biology and ecology, tailored specifically to the UK’s unique situation. It embodies approaches that work with, rather than against, nature (11). Sustainability principles have already been applied successfully to other sectors such as energy, construction and agriculture.
  • It is now imperative that the diverse range of interests and specialisms (12) involved in the management of human health come together. We owe it to future generations to work together urgently, earnestly and cooperatively to develop and thoroughly evaluate new ways of managing and creating health in our society. This blueprint represents a collaborative effort to give this process much needed momentum.

My very short comments:

  1. I fear that this is meant to include SCAM-practitioners who are neither qualified nor skilled to tackle such tasks.
  2. Dietary supplements (heavily promoted by the ANH) either have pharmacological effects, in which case they too must be seen as pharmaceuticals, or they are useless, in which case we should not promote them.
  3. I think ‘some of these’ would be more correct.
  4. Multifactorial yes, but we must make sure that useless SCAMs are not being pushed in through the back-door. Quackery must not be allowed to become a ‘factor’.
  5. Only, if we discount cancer and arteriosclerosis, I think.
  6. SCAM-practitioners have repeatedly demonstrated to be a risk to public health.
  7. All we know about disease prevention originates from conventional medicine and nothing from SCAM.
  8. Informed by…??? I would prefer ‘based on evidence’ (evidence being one term that the report does not seem to be fond of).
  9. All healthy dietary and lifestyle choices and behaviours that are backed by good evidence originate from and are part of conventional medicine, not SCAM.
  10. Do I detect the nasty whiff a pro-Brexit attitude her? I wonder what the ANH hopes for in a post-Brexit UK.
  11. The old chestnut of conventional medicine = unnatural and SCAM = natural is being warmed up here, it seems to me. Fallacy galore!
  12. The ANH would probably like to include a few SCAM-practitioners here.

Call me suspicious, but to me this ANH-initiative seems like a clever smoke-screen behind which they hope to sell their useless dietary supplements and homeopathic remedies to the unsuspecting British public. Am I mistaken?

An article referring to comments Prof David Colquhoun and I recently made in THE TIMES about acupuncture for children caught my attention. In it, Rebecca Avern, an acupuncturist specialising in paediatrics and heading the clinical programme at the College of Integrated Chinese Medicine, makes a several statements which deserve a comment. Here is her article in full, followed by my short comments.

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Just before Christmas an article appeared in the Times with the headline ‘Professors raise alarm over rise of acupuncture for children’. There has been little or nothing in the mainstream press relating to paediatric acupuncture. So, in a sense, and in the spirit of ‘all press is good press’, this felt like progress. The article quoted myself and Julian Scott, and mentioned several childhood conditions for which children seek treatment. It also mentioned some of the reasons that parents choose acupuncture for their children.

However, it included some negative quotes from our old friends Ernst and Colquhoun. The first was Ernst stating that he was ‘not aware of any sound evidence showing that acupuncture is effective for any childhood conditions’. Colquhoun went further to state that there simply is not ‘the slightest bit of evidence to suggest that acupuncture helps anything in children’. Whilst they may not be aware of it, good evidence does exist, albeit for a limited number of conditions. For example, a 2016 meta-analysis and systematic review of the use of acupuncture for post-operative nausea and vomiting (PONV) concluded that children who received acupuncture had a significantly lower risk of PONV than those in the control group or those who received conventional drug therapy.[i]

Ernst went on to mention the hypothetical risk of puncturing a child’s internal organs but he failed to provide evidence of any actual harm. A 2011 systematic review analysing decades of acupuncture in children aged 0 to 17 years prompted investigators to conclude that acupuncture can be characterised as ‘safe’ for children.[ii]

Ernst also mentioned what he perceived is a far greater risk. He expressed concern that children would miss out on ‘effective’ treatment because they are having acupuncture. In my experience running a paediatric acupuncture clinic in Oxford, this is not the case. Children almost invariably come already having received a diagnosis from either their GP or a paediatric specialist. They are seeking treatment, such as in the case of bedwetting or chronic fatigue syndrome, because orthodox medicine is unable to effectively treat or even manage their condition. Alternatively, their condition is being managed by medication which may be causing side effects.

When it comes to their children, even those parents who may have reservations about orthodox medicine, tend to ensure their child has received all the appropriate exploratory tests. I have yet to meet a parent who will not ensure that their child, who has a serious condition, has the necessary medication, which in some cases may save their lives, such as salbutamol (usually marketed as Ventolin) for asthma or an EpiPen for anaphylactic reactions. If a child comes to the clinic where this turns out not to be the case, thankfully all BAcC members have training in a level of conventional medical sciences which enables them to spot ‘red flags’. This means that they will inform the parent that their child needs orthodox treatment either instead of or alongside acupuncture.

The article ended with a final comment from Colquhoun who believes that ‘sticking pins in babies is a rather unpleasant form of health fraud’. It is hard not to take exception to the phrase ‘sticking pins in’, whereas what we actually do is gently and precisely insert fine, sterile acupuncture needles. The needles used to treat babies and children are usually approximately 0.16mm in breadth. The average number of needles used per treatment is between two and six, and the needles are not retained. A ‘treatment’ may include not only needling, but also diet and lifestyle advice, massage, moxa, and parental education. Most babies and children find an acupuncture treatment perfectly acceptable, as the video below illustrates.

The views of Colquhoun and Ernst also beg the question of how acupuncture compares in terms of safety and proven efficacy with orthodox medical treatments given to children. Many medications given to children are so called ‘off-label’ because it is challenging to get ethical approval for randomised controlled trials in children. This means that children are prescribed medicines that are not authorised in terms of age, weight, indications, or routes of administration. A 2015 study noted that prescribers and caregivers ‘must be aware of the risk of potential serious ADRs (adverse drug reactions)’ when prescribing off-label medicines to children.[iii]

There are several reasons for the rise in paediatric acupuncture to which the article referred. Most of the time, children get better when they have acupuncture. Secondly, parents see that the treatment is gentle and well tolerated by their children. Unburdened by chronic illness, a child can enjoy a carefree childhood, and they can regain a sense of themselves as healthy. A weight is lifted off the entire family when a child returns to health. It is my belief that parents, and children, vote with their feet and that, despite people such as Ernst and Colquhoun wishing it were otherwise, more and more children will receive the benefits of acupuncture.

[i] Shin HC et al, The effect of acupuncture on post-operative nausea and vomiting after pediatric tonsillectomy: A meta-analysis and systematic review. Accessed January 2019 from: https://www.ncbi.nlm.nih.gov/pubmed/26864736

[ii] Franklin R, Few Serious Adverse Events in Pediatric Needle Acupuncture. Accessed January 2019from: https://www.medscape.com/viewarticle/753934?src=trendmd_pilot

[iii] Aagaard L (2015) Off-Label and Unlicensed Prescribing of Medicines in Paediatric Populations: Occurrence and Safety Aspects. Basic and Clinical Pharmacology and Toxicology. Accessed January 2019 from: https://onlinelibrary.wiley.com/doi/pdf/10.1111/bcpt.12445

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  1. GOOD EVIDENCE: The systematic review cited by Mrs Avern was based mostly on poor-quality trials. It even included cohort studies without a control group. To name it as an example of good evidence, merely discloses an ignorance about what good evidence means.
  2. SAFETY: The article Mrs Avern referred to is a systematic review of reports on adverse events (AEs) of acupuncture in children. A total of 279 AEs were found.  Of these, 25 were serious (12 cases of thumb deformity, 5 infections, and 1 case each of cardiac rupture, pneumothorax, nerve impairment, subarachnoid haemorrhage, intestinal obstruction, haemoptysis, reversible coma, and overnight hospitalization), 1 was moderate (infection), and 253 were mild. The mild AEs included pain, bruising, bleeding, and worsening of symptoms. Considering that there is no reporting system of such AEs, this list of AEs is, I think, concerning and justifies my concerns over the safety of acupuncture in children. The risks are certainly not ‘hypothetical’, as Mrs Avern claimed, and to call it thus seems to be in conflict with the highest standard of professional care (see below). Because the acupuncture community has still not established an effective AE-surveillance system, nobody can tell whether such events are frequent or rare. We all hope they are infrequent, but hope is a poor substitute for evidence.
  3. COMPARISON TO OTHER TREATMENTS: Mrs Avern seems to think that acupuncture has a better risk/benefit profile than conventional medicine. Having failed to show that acupuncture is effective and having demonstrated that it causes severe adverse effects, this assumption seems nothing but wishful thinking on her part.
  4. EXPERIENCE: Mrs Avern finishes her article by telling us that ‘children get better when they have acupuncture’. She seems to be oblivious to the fact that sick children usually get better no matter what. Perhaps the kids she treats would have improved even faster without her needles?

In conclusion, I do not doubt the good intentions of Mrs Avern for one minute; I just wished she were able to develop a minimum of critical thinking capacity. More importantly, I am concerned about the BRITISH ACUPUNCTURE COUNCIL, the organisation that published Mrs Avern’s article. On their website, they state: The British Acupuncture Council is committed to ensuring all patients receive the highest standard of professional care during their acupuncture treatment. Our Code of Professional Conduct governs ethical and professional behaviour, while the Code of Safe Practice sets benchmark standards for best practice in acupuncture. All BAcC members are bound by these codes. Who are they trying to fool?, I ask myself.

Spinal epidural haematoma (SEH) is an uncommon but serious emergency condition. A team of emergency physicians reported the case of a SEH associated with traditional massage initially presenting with delayed lower paraplegia.

A 20-year-old man was seen with bilateral lower extremity weakness and numbness, symptoms that had started three hours prior to presentation. He had received a Thai massage by a friend three days before. Magnetic resonance imaging revealed a spinal epidural lesion suspicious for haematoma extending from C6 to T2 levels. Emergent surgical intervention for cord decompression was performed. An epidural haematoma with cord compression at C6-T2 levels was identified intra-operatively. No evidence of abnormal vascular flow or AV malformations was identified. The authors concluded that, similar to chiropractic manipulation, massage may be associated with spinal trauma. Emergency physicians must maintain a high index of suspicion for spinal epidural haematomas in patients with a history of massage or chiropractic manipulation with neurologic complaints, because delays in diagnosis may worsen clinical outcome.

Thai massage therapists typically use no lubricants. The patient remains clothed during a treatment. There is constant body contact between the therapist – who, in the above case, was a lay person – and the patient.

The authors of this case report rightly stress that such adverse events are rare – but they are by no means unknown. In 2003, I reviewed the risks and found 16 reports of adverse effects as well as 4 case series on the subject (like for all other manual therapies, there is no reporting system of adverse effects). The majority of adverse effects were – like the above case – associated with exotic types of manual massage or massage delivered by laymen. Professionally trained massage therapists were rarely implicated. The reported adverse events include cerebrovascular accidents, displacement of a ureteral stent, embolization of a kidney, haematoma, leg ulcers, nerve damage, posterior interosseous syndrome, pseudoaneurism, pulmonary embolism, ruptured uterus, strangulation of neck, thyrotoxicosis and various pain syndromes. In the majority of these instances, there was little doubt about a cause-effect relationship. Serious adverse effects were associated mostly with massage techniques other than ‘Swedish’ massage.

For patients, this means that massage is still amongst the safest form of manual therapy (best to employ qualified therapists and avoid the exotic versions of massage because they are not supported by evidence and carry the highest risks). For doctors, it means to be vigilant, if patients present with neurological problems after having enjoyed a massage.

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