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

medical ethics

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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.

In a previous post, I have tried to explain that someone could be an expert in certain aspects of homeopathy; for instance, one could be an expert:

  • in the history of homeopathy,
  • in the manufacture of homeopathics,
  • in the research of homeopathy.

But can anyone really be an expert in homeopathy in a more general sense?

Are homeopaths experts in homeopathy?

OF COURSE THEY ARE!!!

What is he talking about?, I hear homeopathy-fans exclaim.

Yet, I am not so sure.

Can one be an expert in something that is fundamentally flawed or wrong?

Can one be an expert in flying carpets?

Can one be an expert in quantum healing?

Can one be an expert in clod fusion?

Can one be an expert in astrology?

Can one be an expert in telekinetics?

Can one be an expert in tea-leaf reading?

I am not sure that classical homeopaths can rightfully called experts in classical homeopathy (there are so many forms of homeopathy that, for the purpose of this discussion, I need to focus on the classical Hahnemannian version).

An expert is a person who is very knowledgeable about or skilful in a particular area. An expert in any medical field (say neurology, gynaecology, nephrology or oncology) would need to have sound knowledge and practical skills in areas including:

  • organ-specific anatomy,
  • organ-specific physiology,
  • organ-specific pathophysiology,
  • nosology of the medical field,
  • disease-specific diagnostics,
  • disease-specific etiology,
  • disease-specific therapy,
  • etc.

None of the listed items apply to classical homeopathy. There are no homeopathic diseases, homeopathy is largely detached from knowledge in anatomy, physiology and pathophysiology, homeopathy disregards the current knowledge of etiology, homeopathy does not apply current criteria of diagnostics, homeopathy offers no rational mode of action for its interventions.

An expert in any medical field would need to:

  • deal with facts,
  • be able to show the effectiveness of his methods,
  • be part of an area that makes progress,
  • benefit from advances made elsewhere in medicine,
  • would associate with other disciplines,
  • understand the principles of evidence-based medicine,
  • etc.

None of these features apply to a classical homeopath. Homeopaths substitute facts for fantasy and wishful thinking, homeopaths cannot rely on sound evidence regarding the effectiveness of their therapy, classical homeopaths are not interested in progressing their field but religiously adhere to Hahnemann’s dogma, homeopaths do not benefit from the advances made in other areas of medicine, homeopaths pursue their sectarian activities in near-complete isolation, homeopaths make a mockery of evidence-based medicine.

Collectively, these considerations would seem to indicate that an expert in homeopathy is a contradiction in terms. Either you are an expert, or you are a homeopath. To be both seems an impossibility – or, to put it bluntly, an ‘expert’ in homeopathy is an adept in nonsense and a virtuoso in ignorance.

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.

As you know, I have repeatedly written about integrative cancer therapy (ICT). Yet, to be honest, I was never entirely sure what it really is; it just did not make sense – not until I saw this announcement. It left little doubt about the nature of ICT.

As it is in German, allow me to translate it for you [the numbers added to the text refer to my comments below]:

ICT is a method of treatment that views humans holistically [1]. The approach is characterised by a synergistic application (integration) of all conventional [the actual term used is a derogatory term coined by Hahnemann to denounce the prevailing medicine of his time], immunological, biological and psychological insights [2]. In this spirit, also personal needs and subjective experiences of disease are accounted for [3]. The aim of this special approach is to offer cancer patients an individualised, interdisciplinary treatment [4].

Besides surgery, chemotherapy and radiotherapy, ICT also includes hormone therapy, hyperthermia, pain management, immunotherapy, normalisation of metabolism, stabilisation of the psyche, physical activity, dietary changes, as well as substitution of vital nutrients [5].

With ICT, the newest discoveries of cancer research are being offered [6], that support the aims of ICT. Therefore, the aims of the ICT doctor include continuous research of the world literature on oncology [7]…

Likewise, one has to start immediately with measures that help prevent metastases and tumour progression [8]. Both the maximization of survival and the optimisation of quality of life ought to be guaranteed [9]. Therefore, the alleviation of the side-effects of the aggressive therapies are one of the most important aims of ICT [10]…

HERE IS THE GERMAN ORIGINAL

Die integrative Krebstherapie ist eine Behandlungsmethode, die den Menschen in seiner Ganzheit sieht und sich dafür einsetzt. Ihre Behandlungsweise ist gekennzeichnet durch die synergetische Anwendung (Integration) aller sinnvollen schulmedizinischen, immunologischen, biologischen und psychologischen Erkenntnisse. In diesem Sinne werden auch die persönlichen Bedürfnisse und die subjektiven Krankheitserlebnisse berücksichtigt. Ziel dieser besonderen Therapie ist es, dass dem Krebspatienten eine individuell eingerichtete und interdisziplinär geplante Behandlung angeboten wird.

Zur integrativen Krebstherapie gehört neben der operativen Tumorbeseitigung, Chemotherapie und Strahlentherapie auch die Hormontherapie, Hyperthermie, Schmerzbeseitigung, Immuntherapie, Normalisierung des Stoffwechsels, Stabilisierung der Psyche, körperliche Aktivierung, Umstellung der Ernährung sowie die Ergänzung fehlender lebensnotwendiger Vitalstoffe.

Mit dieser Behandlungsmethode werden auch die neuesten Entdeckungen der Krebsforschung angeboten, die die Ziele der Integrativen Krebstherapie unterstützen. Deshalb sind die ständigen Recherchen der umfangreichen Ergebnisse der Onkologie-Forschung in der medizinischen Weltliteratur auch Aufgabe der Mediziner in der Integrativen Krebstherapie…

Ebenso sollte auch sofort mit den Maßnahmen begonnen werden, die helfen, dieMetastasen Bildung und Tumorprogredienz zu verhindern. Nicht nur die Maximierung des Überlebens, sondern auch die Optimierung der Lebensqualität sollen gewährleistet werden. Deshalb ist auch die Linderung der Nebenwirkungen der aggressiven Behandlungsmethoden eines der wichtigsten Ziele der Integrativen Krebstherapie….

MY COMMENTS

  1. Actually, this describes conventional oncology!
  2. Actually, this describes conventional oncology!
  3. Actually, this describes conventional oncology!
  4. Actually, this describes conventional oncology!
  5. Actually, this describes conventional oncology!
  6. Actually, this describes conventional oncology!
  7. Actually, this describes conventional oncology!
  8. Actually, this describes conventional oncology!
  9. Actually, this describes conventional oncology!
  10. Actually, this describes conventional oncology!

ICT might sound fine to many consumers. I can imagine that it gives confidence to some patients. But it really is nothing other than the adoption of the principles of good conventional cancer care?

No!

But in this case, ICT is just a confidence trick!

It is a confidence trick that allows the trickster to smuggle no end of SCAM into routine cancer care!

Or did I miss something here?

Am I perhaps mistaken?

Please, do tell me!

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.

Pertussis (whooping-cough) is a serious condition. Today, we have vaccinations and antibiotics against it and therefore it is rarely a fatal disease. A century or so, the situation was different. Then all sorts of quacks claimed to be able to treat pertussis and many patients, particularly children, died.

This article starts with this amazing introduction: Osteopathic physicians may want to consider using osteopathic manipulative treatment (OMT) as an adjunctive treatment modality for pertussis; however, suitable OMT techniques are not specified in the research literature.

For the paper, the author then searched the historical osteopathic literature to identify OMT techniques that were used in the management of pertussis in the pre-antibiotic era. The 24 identified sources included 8 articles and 16 book contributions from the years 1886 to 1958. Most sources were published within the first quarter of the 20th century. Commonly identified OMT techniques included mobilization techniques, lymphatic pump techniques, and other manipulative techniques predominantly in the cervical and thoracic regions.

The author concluded that the wealth of OMT techniques for patients with pertussis that were identified suggests that pertussis was commonly treated by early osteopaths. Further research is necessary to identify or establish the evidence base for these techniques so that in case of favorable outcomes, their use by osteopathic physicians is justified as adjunctive modalities when encountering a patient with pertussis.

I found it hard to decide whether to laugh or to cry after reading this. One could easily have a good giggle about the silliness of the idea to revive obsolete techniques for treating a potentially serious infection. One the other hand, I cannot help but ask myself:

  • Is there any suggestion at all that OMT was successful in treating pertussis?
  • If the answer is negative (and I fear it is), why would anyone spend considerable resources to establish the evidence base for these techniques?
  • Do osteopaths believe in progress at all?
  • Do they really think that there is even a remote chance that mobilization techniques, lymphatic pump techniques, and other manipulative techniques will, one day, come back as adjunctive therapies for pertussis?
  • Do they not believe in a rational approach to prioritising medical research such that scarce resources are spent ethically and wisely?

You may think that none of this really matters. The author of this paper is just a lone loon! That may well be so, but even lone loons can do a lot of harm, if they convince consumers of their bizarre ideas.

But surely, the profession of osteopathy would not tolerate this, you say. I am not convinced. The article was published in the Journal of the American Osteopathic Association. This seems significant to me. It is comparable to the JAMA or the BMJ publishing an article calling for a programme of research into the possible benefits of blood-letting as a treatment of pneumonia!

 

 

Acupuncture is all over the news today. The reason is a study just out in BMJ-Open.

The aim of this new RCT was to investigate the efficacy of a standardised brief acupuncture approach for women with moderate-tosevere menopausal symptoms. Nine Danish primary care practices recruited 70 women with moderate-to-severe menopausal symptoms. Nine general practitioners with accredited education in acupuncture administered the treatments.

The acupuncture style was western medical with a standardised approach in the pre-defined acupuncture points CV-3, CV-4, LR-8, SP-6 and SP-9. The intervention group received one treatment for five consecutive weeks. The control group received no acupuncture but was offered treatment after 6 weeks. Outcomes were the differences between the two groups in changes to mean scores using the scales in the MenoScores Questionnaire, measured from baseline to week 6. The primary outcome was the hot flushes scale; the secondary outcomes were the other scales in the questionnaire. All analyses were based on intention-to-treat analysis.

Thirty-six patients received the intervention, and 34 were in the control group. Four participants dropped out before week 6. The acupuncture intervention significantly decreased hot flushes, day-and-night sweats, general sweating, menopausal-specific sleeping problems, emotional symptoms, physical symptoms and skin and hair symptoms compared with the control group at the 6-week follow-up. The pattern of decrease in hot flushes, emotional symptoms, skin and hair symptoms was already apparent three weeks into the study. Mild potential adverse effects were reported by four participants, but no severe adverse effects were reported.

The authors concluded that the standardised and brief acupuncture treatment produced a fast and clinically relevant reduction in moderate-to-severe menopausal symptoms during the six-week intervention.

The only thing that I find amazing here is the fact the a reputable journal published such a flawed trial arriving at such misleading conclusions.

  • The authors call it a ‘pragmatic’ trial. Yet it excluded far too many patients to realistically qualify for this characterisation.
  • The trial had no adequate control group, i.e. one that can account for placebo effects. Thus the observed outcomes are entirely in keeping with the powerful placebo effect that acupuncture undeniably has.
  • The authors nevertheless conclude that ‘acupuncture treatment produced a fast and clinically relevant reduction’ of symptoms.
  • They also state that they used this design because no validated sham acupuncture method exists. This is demonstrably wrong.
  • In my view, such misleading statements might even amount to scientific misconduct.

So, what would be the result of a trial that is rigorous and does adequately control for placebo-effects? Luckily, we do not need to rely on speculation here; we have a study to demonstrate the result:

Background: Hot flashes (HFs) affect up to 75% of menopausal women and pose a considerable health and financial burden. Evidence of acupuncture efficacy as an HF treatment is conflicting.

Objective: To assess the efficacy of Chinese medicine acupuncture against sham acupuncture for menopausal HFs.

Design: Stratified, blind (participants, outcome assessors, and investigators, but not treating acupuncturists), parallel, randomized, sham-controlled trial with equal allocation. (Australia New Zealand Clinical Trials Registry: ACTRN12611000393954)

Setting: Community in Australia.

Participants: Women older than 40 years in the late menopausal transition or postmenopause with at least 7 moderate HFs daily, meeting criteria for Chinese medicine diagnosis of kidney yin deficiency.

Interventions:10 treatments over 8 weeks of either standardized Chinese medicine needle acupuncture designed to treat kidney yin deficiency or noninsertive sham acupuncture.

Measurements: The primary outcome was HF score at the end of treatment. Secondary outcomes included quality of life, anxiety, depression, and adverse events. Participants were assessed at 4 weeks, the end of treatment, and then 3 and 6 months after the end of treatment. Intention-to-treat analysis was conducted with linear mixed-effects models.

Results: 327 women were randomly assigned to acupuncture (n = 163) or sham acupuncture (n = 164). At the end of treatment, 16% of participants in the acupuncture group and 13% in the sham group were lost to follow-up. Mean HF scores at the end of treatment were 15.36 in the acupuncture group and 15.04 in the sham group (mean difference, 0.33 [95% CI, −1.87 to 2.52]; P = 0.77). No serious adverse events were reported.

Limitation: Participants were predominantly Caucasian and did not have breast cancer or surgical menopause.

Conclusion: Chinese medicine acupuncture was not superior to noninsertive sham acupuncture for women with moderately severe menopausal HFs.

My conclusion from all this is simple: acupuncture trials generate positive findings, provided the researchers fail to test it rigorously.

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.

 

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.

START OF QUOTE

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

END OF QUOTE

  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.

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