Former osteopath continues to mislead the public and claims that “doctors know very little about health”

In January 2018 the osteopath Mark Mathews was removed from the register of practicing osteopaths for unacceptable professional conduct. However, he continues to run his practice Reve Pavilion where he works as a “Natural Health Practitioner”. He is also the president of the charity The Sunflower Trust which makes wildly misleading claims about the suitability of their treatments for children. I’ve written about that previously here and here. On the Reve Pavilion website there are a number of misleading claims including:

  • Misleading information about other evidence-based treatments and doctors including the claim that “doctors know very little about health”
  • Treatment of conditions for which it is highly implausible that osteopathy could be of any benefit
  • Use of cranial osteopathy

Let’s look into each of these in a little more detail.

Misleading information about other evidence-based treatments and doctors

In the “Mark’s blog” section of the Reve Pavilion website it suggests that anti-inflammatory drugs, antacids and anti-histamines are harmful and that taking anti-depressants is not helpful for depression. This is misleading, doesn’t present a balanced view of the evidence and could discourage someone from taking appropriate evidence-based medical treatments. There is also a post entitled “medical doctors know very little about health”. That post is full of conspiracy theories and makes several false claims. For instance, it says that “Nearly all the background research papers that are published are sponsored by the drug industry”. Whilst it is true that pharmaceutical companies undertake a significant amount of research, there is also research that is funded by governments and charities and carried out by universities and other research organisations. He also goes on to say “The normal state of all living things is to be well given the right environment”. Is it the case that people won’t get cancer if they are “given the right environment”? Of course not! This is complete nonsense but it is perhaps not a large stretch from the beliefs of many osteopaths who claim to “restore the body to a state of balance”. It is clear that someone with such extreme views presents a risk to the public.

I should state at this point that I don’t think that Mark Mathews unreasonable criticism of doctors is representative of the osteopathic profession as a whole. He is clearly at a fairly extreme end of the spectrum in terms of his beliefs and approaches. Misleading claims and use of unsuitable treatments are widespread within the osteopathy profession but it is quite unusual for osteopaths to publically criticise doctors in such an extreme manner.

Treatment of conditions for which it is highly implausible that osteopathy could be of any benefit

In the common conditions section of the Reve Pavilion website it claims that they are able to treat a wide range of conditions including allergies, anxiety, stress, depression, insomnia and menopausal symptoms. In the “Mark’s blog” section of the website it is suggested that “functional neurology”, “natural medicine” and osteopathy treatments available at Reve Pavilion are beneficial for urinary incontinence, depression, menopausal symptoms, asthma, menstrual pain and diet problems. In reality, none of the treatments offered at Reve Pavilion have been shown to be effective for any of these conditions. There is simply no plausible mechanism by which osteopathy or any similar treatment could possibly provide any benefit for these conditions. The section on migraines and headaches suggests that the treatments on offer are suitable for all types of headaches. Osteopathy has actually not been shown to be effective for headaches in general or for migraines specifically.

Cranial osteopathy

There are two sections of the Reve Pavilion website that focus on cranial osteopathy: here and here. It claims that it is effective for a wide range of conditions including anxiety, depression, insomnia, feeling run down, sports injuries, whiplash, headaches, musculoskeletal pain, learning difficulties and behavioural difficulties. The website also suggests that “abnormal births” may cause problems that can be treated by cranial osteopathy. Finally, it claims that cranial osteopaths can feel the involuntary motion.  In reality, cranial osteopathy is a fanciful concept based on something that doesn’t exist. There is no such thing as a cranial rhythm. Unsurprisingly, it has not been shown to provide any benefit for any health condition.

Complaint to the Advertising Standards Authority

I complained to the Advertising Standards Authority (ASA) about the many misleading advertising claims made by Reve Pavilion. The response from the ASA was to refer this to their compliance team. They do this when they have already seen plenty of misleading adverts about a particular issue and have established a standard position on it. The ASA said “your complaint raises an issue which we know is a clear problem under the rules”. Although the Compliance team will not report to me directly, it will be interesting to see what happens to the advertising on the Reve Pavilion website.

Conclusions

Here is a former osteopath who continues to make wildly misleading claims about the suitability of the treatments he has to offer as well undermining doctors and evidence-based treatments. He clearly represents a significant risk to the public. The General Osteopathic Council (GOsC) have already removed him from their register for unacceptable professional conduct and so he no longer falls under their remit. There appears to be a significant regulatory problem here because he no longer falls under the GOsC as he is not an osteopath but there is no other organisation that then picks up responsibility for regulating him. He therefore seems to be able to continue to practice uncontrolled in spite of the risk he presents to the public. Any suggestions on where he could be reported to would be welcomed.

Alternative Medicine – A Critical Assessment of 150 Modalities: book review

Alternative-Medicine-a-critical-assessment-of-150-modalitiesAlternative Medicine – A Critical Assessment of 150 Modalities, written by Edzard Ernst, is a book focused on alternative medicine and sets out to provide a “comprehensive, critical yet fair summary of the evidence that is easily accessible to a lay-person”. It is split into two main parts. Part 1 looks at general issues relating to alternative medicine and part 2 goes into 150 alternative therapies and diagnostic methods. Overall, this is a very good book and anyone reading it is going to be much better informed about the (un)suitability of most types of alternative medicine than they were before starting.

In part 1 there are some real “nuggets” of information about what makes alternative medicine attractive, the problems with alternative medicine and the approaches that alternative medicine practitioners use to promote their treatments. I’ll go through each of the 6 chapters in a little more detail shortly but I’d like to whet your appetite with something I think is critically important: the indirect risks of alternative medicine. This is highlighted in section 3.2 “Alternative Medicine Is Risk-Free”. The book says “Indirect risks are not caused by the treatment per se but arise in the context in which therapy is given. If, for instance, a completely harmless but ineffective alternative treatment replaces a vital conventional one, the harmless therapy becomes life-threatening.” Personally, I think this is really important and I believe that if the general public fully understand the level of indirect risk that seeing a homeopath, chiropractor, osteopath, naturopath, acupuncturist or other alternative practitioner presents most people would never go to see one again.

The second part of the book (chapters 7-11) goes through 150 alternative therapies and diagnostic methods assessing each in turn for plausibility, efficacy, safety, cost, risk / benefit balance. It provides nice succinct summaries of many alternative therapies that you have probably heard of as well as a good number that you probably haven’t. Are you thinking about trying acupuncture, gua sha or chiropractic? Check out this section of the book first for a summary of each of these treatments and many more.

Chapter 1 Introduction

The first chapter highlights the large number of books on alternative medicine and how so many of them promote “bogus, potentially harmful treatments”. This book sets out to provide a “comprehensive, critical yet fair summary of the evidence that is easily accessible to a lay-person”. As the book itself says this is a large and challenging task. Is Edzard the right person to take this on? The book claims that he is, and I agree. He arguably has more knowledge and experience in this area than anyone else including having published more peer-reviewed articles on the subject.

This chapter also explains the way that each of the 150 modalities are evaluated and the rating system used to assess each of them in the five areas of plausibility, efficacy, safety, cost, risk / benefit balance. The rating system is deliberately simple which doesn’t allow for much subtlety:

rating scale Edzard Ernst

Personally, I think this simple approach is appropriate for the intended aims of the book – to provide information that is easily accessible for the lay-person. This is a good introductory chapter.

Chapter 2 Why Evidence?

This chapter aims to answer the questions “What is evidence?” and “Why is it important?”. To start with, this chapter tackles the notion that a patient getting better isn’t necessarily a result of the treatment they are receiving. Put another way, correlation does not equal causation. The book offers a few alternative explanations for a patient improving after treatment:

  • the natural history of the condition (most conditions get better, even if they are not treated at all)
  • regression towards the mean (outliers tend to return to the mean when we re-check them)
  • the placebo-effect (expectation and conditioning affect how we feel)
  • concomitant treatments (people often take more than one treatment when ill)
  • social desirability (patients tend to claim they are better simply to please their therapist)

I agree with all of these points. However, I think the book has lost track of its intended audience a bit here: the lay-person. Would a member of the public who has no particular experience with science be expected to understand all of the above? Take for instance “regression towards the mean (outliers tend to return to the mean when we re-check them)”. I don’t think that most people outside the science / medical community would understand the term “regression towards the mean” and even the explanation in brackets is still rather “sciencey”. Perhaps a better lay explanation would be something like: “People often go for a treatment when they are feeling at their worst. Because many conditions have fluctuating symptoms, it is likely that with time they will return to something more like their average symptoms even without treatment. ”

The book then looks at what is suitable as evidence and why it’s important. The book, correctly, suggests that controlled clinical trials are the best way of determining if a treatment caused the improvement and the treatment is therefore effective. The book acknowledges that clinical trials are not perfect (they aren’t) but they are the best way that we have of assessing treatment effectiveness.

I think that overall this chapter is more science-focused than any other. That’s understandable as explaining what evidence is and why it’s important does require some science. However, I do wonder if members of the general public without any science background might find some of what’s in here a bit difficult to follow. Overall it’s still a decent chapter but perhaps some re-wording / additional explanation would have been beneficial in some parts?

Chapter 3 The Attractiveness of Alternative Medicine

Alternative medicine is undoubtedly popular and this chapter tackles a number of the unsubstantiated claims alternative medicine practitioners make in order to sell their services:

  • Alternative medicine is effective
  • Alternative medicine is risk free
  • Alternative medicine is natural
  • Alternative medicine is holistic
  • Alternative medicine has stood the test of time
  • Alternative medicine tackles the root causes of an illness
  • Alternative medicine is inexpensive
  • Alternative medicine is a small, innocent cottage industry
  • Alternative practitioners are more human
  • Conventional medicine does not live up to its promises

I often see alternative medicine practitioners making these sorts of claims. Edzard tackles each one in turn in his book. One point that he makes is of particular importance I think. He highlights that one important reason for the popularity of alternative medicine is the failings of conventional medicine (sections 3.10 & 3.11 in the book). That makes a lot of sense. How often do we see someone who has been told that their cancer is terminal going to a “cancer clinic” that offers fake “cures”. It’s unfortunate that sometimes there just aren’t solutions available through conventional medicine. When someone is told by a doctor that there is nothing that can be done to help them it’s entirely natural that they look elsewhere as they need someone to give them hope. That’s when alternative medicine practitioners step in and offer people false hope by claiming that they can help (even though they usually can’t).

Chapter 4 The Unattractiveness of Alternative Medicine

This chapter goes through the reasons why alternative medicine is unsuitable:

  • It is not plausible
  • There is no evidence
  • The “Promised Land” for charlatans
  • Pseudo-science

The book highlights the large number of papers that have been published about alternative medicine. In most cases, those trials that are of high quality fail to demonstrate that alternative medicine is effective.

This chapter and the previous one should help members of the public to know how to spot misleading claims.

Chapter 5 Ethical Problems in Alternative Medicine

Ethics is a complex and important topic in the context of any medical treatment, including alternative medicine. This chapter highlights the numerous ethical problems with alternative medicine including informed consent, neglect, competence, truth and risk / benefit analysis. Informed consent is a particular challenge for all types of alternative medicine. For a practitioner of alternative medicine to take true informed consent they would normally have to admit that their treatments are not particularly effective and that there are other better treatments available. As the book explains this would be bad for business and means that alternative medicine practitioners have a powerful conflict of interest that keeps them from adhering to the rules of informed consent and medical ethics. The book gives a very good example of potential encounters with a chiropractor to help explain this.

Chapter 6 Other Issues

This chapter picks up on other issues relating to alternative medicine that don’t fit in the earlier chapters including patient choice, science cannot explain and integrative medicine. I think the last part of the chapter is particularly interesting as it covers what conventional healthcare professionals could say when asked about alternative medicine by a patient. The book suggest four different approaches, some better than others. One of the challenges for conventional healthcare professionals is that they often lack sufficient knowledge about alternative medicine to be able to talk about the evidence (or lack of evidence) behind them. Whilst the book is aimed primarily at the lay person it may also be helpful for conventional healthcare professionals to inform themselves about the evidence and risks of alternative medicine.

Part 2

The second part of the book (chapters 7-11) goes through 150 alternative therapies and diagnostic methods assessing each in turn for plausibility, efficacy, safety, cost, risk / benefit balance. The breadth of modalities covered here is seriously impressive. I’ve been tackling misleading claims in alternative medicine for a number of years and there were a reasonable number of therapies and diagnostic methods that I’d never heard of such as Jin Shin Jyutsu, Kirlian Photography and Eurythmy. As far as I can tell, the assessment of each of the approaches is fair and objective. In fact, I would say that on occasions the assessment is quite generous in favour of some of the alternative therapies. It is certainly not the case that every alternative therapy is criticised. Some are given a positive assessment such as St John’s Wort, Alexander Technique (for chronic low back pain) and Feldenkrais Method.

This section of the book is great for the reader to “dip into” when they want to find out about a particular therapy. It doesn’t go into any of them in great detail, and further reading would be needed here, but it serves as a great reference for a really wide range of alternative therapies and diagnostic methods.

Conclusion

Overall, I think this is an excellent book. It fills an important gap in the market to provide members of the public with objective information about a wide range of alternative medicine approaches. It should help to tackle the widespread misleading (promotional) information that exists around alternative medicine. Readers of this book will undoubtedly be much better informed about the reality of alternative medicine. I just hope the book receives the wide readership it deserves.

 

The Good Thinking Society is challenging the Professional Standards Authority’s reaccreditation of the Society of Homeopaths. Why is this important?

The Professional Standards Authority (PSA) say that they are “here to protect the public and help ensure their health and wellbeing by raising standards in the regulation and registration of people working in health and social care”. Within their activities they provide a set of accredited registers so that as a member of the public you can “choose a practitioner to meet your needs with confidence”. It would therefore be reasonable to expect that the PSA have vetted the providers of their accredited registers to ensure that the treatments their members offer to the public are suitable, effective and, most importantly, safe. However, it would appear that this is not always the case.  Some members of the Society of Homeopaths (SoH) offer a treatment called CEASE therapy. This is a treatment for autism based on the false premise that vaccinations cause autism and that this can be “cured” through a combination of homeopathy, high dose vitamin C and dietary restriction. The link between vaccines and autism has been thoroughly disproved; see this for instance, and there is no evidence that CEASE therapy provides any benefit. The PSA has acknowledged that CEASE therapy is potentially harmful and they are aware that this treatment continues to be provided by some members of the SoH. In order to protect the public, it would therefore be reasonable to expect the PSA to no longer accredit the SoH. In actual fact they have done quite the opposite and on 1st April 2019 they approved accreditation of the SoH for a further year. This decision seems to be in direct conflict with the purpose of the PSA which is to protect the public. No child with autism should be subjected to CEASE therapy and it is very good that the Good Thinking Society is challenging this decision by the PSA via judicial review.

Wider implications

The particular issue here being addressed here is protecting people with autism from being exposed to the completely unsuitable CEASE therapy. This in itself is very important. However, this judicial review potentially has wider implications. It also brings into question whether regulation in the UK actually fulfils its key function of protecting the public or instead lends legitimacy to unproven, unsuitable and potentially harmful treatments. This is important as it would appear that the current approach of the PSA (and other regulators) is not effective in protecting the public from harm from unsuitable treatments.

How can you help?

Here are a few ideas of things that you could do to support the Good Thinking Society with their judicial review:

  • Make a donation
  • Share information about the campaign on social media, such as Twitter or Facebook.
  • Raise awareness with local groups that provide support to people with autism and / or parents of children with autism such as charities or local parent carer forums.
  • Get in touch with the Good Thinking Society to find out how else you could help.

Bournemouth University and AECC University College newborn feeding clinic: integrating unproven chiropractic “treatments” with midwifery

Rulings - ASA - CAP - www.asa.org.uk - AECC feeding clinic croppedThe AECC University College and Bournemouth University provide a joint newborn feeding clinic incorporating midwives and chiropractors. Bournemouth University provides the midwives and AECC University College provides the chiropractors. Midwives clearly have an important role in newborn feeding but what about chiropractors?

Summary of conclusions:

1. There is no good evidence that chiropractic provides any benefit for feeding or any other infant condition.

2. By participating in this joint clinic Bournemouth University is lending an inappropriate legitimacy to a treatment that hasn’t been shown to be effective or safe. Bournemouth University ought to be embarrassed by this association and the potential for deception of parents who are misled into taking their babies to the clinic.

3. There is no situation in which it is appropriate to take your baby to a chiropractor (or osteopath).

4. In order to adequately protect the public it would seem appropriate for the General Chiropractic Council to impose a minimum age limit for treatment by a chiropractor.

About the clinic

The AECC University College Newborn Feeding Clinic says that it is for those who are breastfeeding exclusively or mixed feeding their babies up to 8 weeks of age. This clinic is based on student midwives and chiropractic interns working together. The role of the chiropractic intern includes:

  • Sharing taking of history of pregnancy, birth and any feeding concerns with the student midwife.
  • Undertaking an examination of the baby.
  • Offering advice about positioning and comfort when breastfeeding, along with the student midwife.
  • A chiropractic treatment of the baby.

A chiropractor being involved in the care of a baby at all raises concerns but it is particularly problematic that the chiropractor is undertaking an examination and providing treatment. In spite of many claims from chiropractors (and osteopaths), the reality is that there is no evidence that these treatments provide any benefit for any infant condition. There is also no plausible mechanism by which a chiropractic treatment could provide any benefits for breastfeeding. There is no good reason why a newborn feeding clinic should involve chiropractors and Bournemouth University should be embarrassed to be involved in such nonsense.

Chiropractic treatments haven’t been shown to provide any benefit for babies

Many chiropractors (and osteopaths) offer treatments for babies for a range of different health conditions. In reality, there is no evidence that these treatments provide any benefits for any infant condition. The same is true for older children and I’ve written more about that here. Some chiropractors (and osteopaths) claim that babies experience “birth trauma” that can be corrected with their treatments. In reality, this “birth trauma” only exists in the minds of the chiropractors and osteopaths and isn’t actually a real issue.

Some babies may go for a treatment with a chiropractor and appear to benefit from the treatment. Why does that happen? It’s important to understand that many conditions in infants improve of their own accord as the baby gets older. Children with colic, for instance, usually outgrow this at around 4-6 months of age. If a baby is being “treated” for colic by a chiropractor at the time they outgrow the problem then it’s natural to assume that the treatment helped and not realise that the problem was simply outgrown. In order to unpick this it’s necessary to run clinical trials to test the effectiveness of treatments. When these trials have been conducted they have not shown any benefit for chiropractic treatments for any infant condition. There is also no plausible mechanism by which a chiropractic treatment could provide any benefit for any common infant condition.

Chiropractic treatment for babies hasn’t been shown to be safe

It is not clear whether chiropractic in babies (or adults for that matter) is safe or not because a) many trials of chiropractic treatments do not adequately report adverse events (see this, for instance) and b) there is no standard mechanism for reporting adverse events or safety concerns experienced during routine chiropractic practice. It’s therefore not possible to know whether chiropractic (or osteopathy) for babies is safe.

Published research from the clinic

There are a number of published papers from the clinic. Here are some examples:

  • Demographic profile of 266 mother-infant dyads presenting to a multidisciplinary breastfeeding clinic: a descriptive study – In the abstract for this study it is stated “Musculoskeletal problems were prevalent in the babies presented to the feeding clinic, most commonly of the thoracic spine, cervical spine and sternocleidomastoid”. How were these musculoskeletal “problems” diagnosed? By chiropractors. Chiropractors who treat babies do so based on the mistaken belief that babies suffer “birth trauma” and therefore often present with musculoskeletal “problems” that a chiropractor can fix. In reality, babies don’t suffer this sort of “birth trauma” and there is no evidence that they have musculoskeletal problems that benefit from chiropractic treatment.
  • Parent Reports of Exclusive Breastfeeding After Attending a Combined Midwifery and Chiropractic Feeding Clinic in the United Kingdom – Within this paper they reported that 80 out of 85 infants demonstrated a biomechanical fault that required chiropractic care. This is, of course, utterly ridiculous. The vast majority of infants do not have a “biomechanical fault” and those that do should be treated by a suitably qualified paediatric doctor not a chiropractor. This is a classic case of chiropractors finding a “problem” that requires their “treatment” when such a problem doesn’t actually exist. This further highlights that chiropractors lack the necessary specialist skills to be able to adequately assess babies.
  • Maternal Report of Outcomes of Chiropractic Care for Infants – This paper is thoroughly criticised by Edzard Ernst here. Suffice to say it is a truly woeful piece of “research” that tells us precisely nothing about the suitability of chiropractic care for infants.

Unfortunately, it looks as though the researchers at Bournemouth University who are involved in this work have fully bought into the nonsense that is the chiropractic treatment of babies. This is a serious concern as it involves some senior research staff, one of whom is a Professor of Midwifery Education. It’s disappointing that such experienced research staff have failed to apply some critical thinking and realise that they are promoting a treatment for babies that hasn’t been shown to be effective or safe.

What action can be taken to tackle these unsuitable treatments?

I complained to the Advertising Standards Authority (ASA) about the misleading advertising claims made by the AECC University College Newborn Feeding Clinic. The ASA concluded that the advertising is likely to break their rules. Their response was to contact AECC University College to ensure that “in future the ad will be amended to make clear that the chiropractic element relates to the positioning and comfort of the mother only”. (In other words, there shouldn’t be any treatment of the baby by the chiropractor). Unfortunately, the AECC University College has failed to adequately update their advertising materials in response to this complaint. They still refer to the chiropractic intern undertaking an examination and treatment of the baby. It looks like a further complaint to the ASA is required.

If the ASA are able to get the AECC University College to correct their misleading advertising this would be useful progress but there remains the open question of whether it is appropriate for chiropractors to see babies at all. That isn’t a matter for the ASA but would instead fall under the remit of the regulator, the General Chiropractic Council (GCC). The primary role of the GCC is the protection of the public. As there is no evidence that chiropractic treatments provide any benefit for babies and safety has not been established it would seem to be a reasonable step for the GCC to impose a minimum age limit for chiropractic treatment. This is something that is currently being considered in Australia.

Conclusions

Chiropractic (and osteopathy) treatments have not been shown to be effective for feeding problems or any other infant condition. The safety of these treatments for babies has not been established. There is therefore no good reason to take a baby to a chiropractor and it is completely inappropriate for there to be a joint feeding clinic with chiropractors and midwives. A reputable UK university should not be seen to be promoting such unsuitable treatments and Bournemouth University should be embarrassed by their involvement in this. In order to adequately protect the public it would seem appropriate for the General Chiropractic Council to impose a minimum age limit for treatment by a chiropractor.

 

 

 

Last updated 04/09/19

Acupuncture is not an effective treatment for autism

Earlier this year a report was published on the HealthCMi website claiming that acupuncture is an effective treatment for autism. A number of acupuncturists have linked to that article and used it to promote their treatments on twitter and other social media. The NHS estimates that about 1 in every 100 people in the UK is autistic. If acupuncture were to be found effective for autism, it could therefore provide benefits to a large number of people. Let’s look more closely at these claims.

Summary of conclusions:

1. The principles of acupuncture conflict directly with a modern understanding of science and the human body.

2. Acupuncture has not been shown to be beneficial for autism.

3. Acupuncture treatments cause distress and other side effects for some children.

4. There is no good reason to recommend acupuncture as a treatment for autism.

What is Autism?

The National Autistic Society says:

Autism is a lifelong developmental disability that affects how people perceive the world and interact with others.

Autistic people see, hear and feel the world differently to other people. If you are autistic, you are autistic for life; autism is not an illness or disease and cannot be ‘cured‘. Often people feel being autistic is a fundamental aspect of their identity.

Autism is a spectrum condition. All autistic people share certain difficulties, but being autistic will affect them in different ways.”

What is Acupuncture?

According to Wikipedia, Acupuncture “is a form of alternative medicine in which thin needles are inserted into the body. It is a key component of traditional Chinese medicine (TCM). Acupuncture is a pseudoscience because the theories and practices of TCM are not based on scientific knowledge.”

In the study investigated here it says “In traditional Chinese acupuncture, nearly 400 acupoints on the body surface are interrelated to various functions linked through 14 meridians to various organs or viscera of the human body. By stimulating various meridian points, acupuncture may be able to correct the disharmony and dys-regulation of organ systems, which might be involved in various dimensions of ASD, to relieve symptoms and restore the mind and body.” If this sounds a bit strange, that’s because it’s complete nonsense. The concept of meridians conflicts directly with a modern understanding of the human body. There is no plausible mechanism by which inserting needles could have any effect on “organ systems”.

The article goes on to provide a TCM theory of ASD (Autism Spectrum Disorder): “According to TCM, the pathogenesis of ASD is the derangement and insufficiency of the brain and mind. The pathological involvement is in the brain, relating to the Heart, Pericardium, Liver, Spleen, and Kidney. The etiology results from an innate lesion or insufficiency of the brain/mind and dysregulation of the Heart, Liver, Spleen, and Kidney after birth.” This is also complete nonsense. The National Autistic Society says “Autism is a developmental condition affecting the way the brain processes information.” This is a much clearer and accurate explanation than the one from the paper. In reality, Autism has precisely nothing to do with “dysregulation of the Heart, Liver, Spleen, and Kidney”.

What did the study show?

The main focus of the article was this study, which was published back in 2010. The study has the following conclusion: “A short, 12-session course of electro-acupunc-ture at selected acupoints was found to improve some functions in children with ASD, especially language comprehension and self-care ability. Thus, acupuncture might be a useful adjunctive therapy in early interventional programs for children with autism”. However, there are MANY issues with study and the conclusions drawn are simply not valid. Let’s review some of the biggest issues:

  • Primary and secondary outcomes were switched in the final paper from those specified in the original protocol. The original protocol is specified here: https://clinicaltrials.gov/ct2/show/NCT00346736?term=NCT00346736&rank=1. A number of changes were made in the final paper such as the Aberrant Behavioral Checklist (ABC) switching from a primary outcome measure to secondary and the Leiter International Performance Scale-Revised changing from secondary to primary. The purpose of publishing a protocol in advance is so that it is publicly known and can’t be changed later. Changing it after publication is a really bad practice that means the rest of the research can probably not be trusted.
  • A total of 7 measurement scales were used plus a parental report. Within those 7 measurement scales only 3 of the individual values were found to have a statistically significant improvement in the treatment arm. That’s 3 out of 33 scores that showed improvement. It’s likely that if you assess this many scores, a small number of them will show improvement by pure chance. This result is therefore consistent with a treatment that is NOT effective.
  • The parental report also shows some improvements but this isn’t appropriate to use as solid evidence because a) this is not a standardised measure and b) parental (or self) report is a potentially unreliable way of measuring outcomes.
  • This was a double-blind trial with parents and assessor supposed to be blinded but no assessment of the success of blinding was carried out. It’s therefore impossible to know whether either parents or assessor were truly blind or they discovered / guessed whether they were receiving the treatment or not. If they did discover which treatment they were receiving that is likely to have influenced the results.

In short, the “improvements” observed in this study could very easily (and probably did) occur by pure chance. The results observed in this study are consistent with a treatment that is NOT effective. It is therefore completely inappropriate to recommend acupuncture as a treatment for autism based on this study.

Compliance and safety

In the paper they report that 70 percent of participants achieved “good compliance” with acupuncture treatment. Their definition of compliance is that “subjects were able to sit or lie on a couch to accept acupuncture, even if they cried or needed gentle hand or head holding”. How is a child who is crying during a procedure considered to be “compliant”? There are ethical issues here with exposing children to a treatment which lacks a plausible mechanism of action when the treatment is causing distress.

With regards to side effects they say “the mild side effects of minor superficial bleeding or crying and irritability during acupuncture were experienced by some”. They don’t, however, quantify the number of participants who experienced side effects which is a serious shortcoming in the reporting of this study. Although no serious side effects were reported in this study, a sample size of only 55 is not anywhere near enough to know whether serious side effects may occur. As serious side effects usually occur infrequently, a much larger sample size is needed to assess them.

Is Acupuncture a suitable treatment for autism?

In short, no. The principles behind acupuncture conflict directly with a modern understanding of science and the human body. Acupuncture has not been shown to be effective for autism. The report from HealthCMi is highly misleading and distorts the true picture in an attempt to provide marketing material for acupuncturists. The study on which this is based is full of flaws and in reality the results are more consistent with a treatment that is ineffective. There are serious concerns about the safety of acupuncture as a treatment for autism and the potential to cause distress in this vulnerable patient group during treatment. To conclude, there is no good reason to recommend acupuncture as a treatment for autism.

Should you see a chiropractor or an osteopath for your migraines?

migraineI’ve previously written about the problems with chiropractors and osteopaths claiming to be able to treat all types of headaches. The Advertising Standards Authority (ASA) permits chiropractors and osteopaths to advertise their treatments for only two specific types of headache:

  • Headache arising from the neck (cervicogenic)
  • Migraine prevention

In this post I’m going to look more closely at chiropractic and osteopathy treatment for the prevention and treatment of migraines. How strong is the evidence behind these treatments?

Summary of conclusions:

1. Based on the currently available evidence there doesn’t seem to be any good reason to recommend osteopathy or chiropractic for the prevention or treatment of migraines.

2. The treatments recommended in the NICE guidelines for prevention and treatment of migraines are all available from a GP rather than a chiropractor or osteopath.

3. Further research in this area may be worthwhile as there is currently relatively little good research.

Evidence for chiropractic and osteopathy for migraine prevention

I don’t know the source of the ASA guideline permitting chiropractors and osteopaths to advertise their treatments for migraine prevention. However, it’s probable that at least part of the source is the Effectiveness of manual therapies: the UK evidence report (Bronfort report). Within this publication it states: “The impetus for this report stems from the media debate in the United Kingdom (UK) surrounding the scope of chiropractic care and claims regarding its effectiveness particularly for non-musculoskeletal conditions.” That’s not a very good reason for carrying out research. Regardless, let’s look at what it says about migraine prevention.

The Bronfort report states that there is “Moderate quality evidence that spinal manipulation has an effectiveness similar to a first-line prophylactic prescription medication (amitriptyline) for the prophylactic treatment of migraine”. This is based on 2 systematic reviews of manual therapy for migraine headache. The Bronfort report chooses to discard the results of 1 of the systematic reviews because it “evaluated study quality using a scale that is no longer recommended by the Cochrane Collaboration and did not apply evidence rules for their conclusions”. They chose instead to follow only the conclusions from the other systematic review. Who was the lead author for that systematic review? Gert Bronfort, the same person who is lead author for the Bronfort report. There is clearly a potential conflict of interest here so let’s have a look at the actual papers that formed the basis of both systematic reviews (there are only 3 of them and the same papers are in both reviews):

The first thing that surprises me here is that both systematic reviews found only 3 trials related to manual therapy and migraines. This suggests that it’s an area that is under-researched and makes drawing strong conclusions difficult. Furthermore, the conclusion drawn by the Bronfort report that “Moderate quality evidence that spinal manipulation has an effectiveness similar to a first-line prophylactic prescription medication (amitriptyline) for the prophylactic treatment of migraine” is rather strange. It is based on just a single trial. Drawing conclusions from a single trial is always problematic and we would usually like to see similar results independently replicated in another trial before making any significant recommendations. In fact, given the apparent success of SMT found in this trial, which was conducted over 20 years ago, it’s surprising that there isn’t further published research looking at the same thing in the 12 year period to 2010 (when the Bronfort report was published).

There has been some additional research since 2010. Here is a trial published in 2017: Chiropractic spinal manipulative therapy for migraine: a three-armed, single blinded, placebo, randomized controlled trial . In this trial there were three groups: 1) active – Chiropractic spinal manipulative therapy (CSMT), 2) placebo – sham treatment, 3) control – normal pharmacological management. The authors concluded that “the effect of CSMT observed in our study is probably due to a placebo response”. In other words, the treatment was not effective. The other conclusion drawn by the authors is interesting: “It is possible to conduct a manual-therapy RCT with concealed placebo”. Some osteopaths and chiropractors claim that it’s not possible to adequately test their treatments in a randomised controlled trial (RCT). However, here we have an RCT where the authors concluded that this was entirely possible. It would therefore seem that it’s no longer reasonable to use the excuse that it’s not possible to test osteopathy or chiropractic treatments in an RCT.

NICE Guidelines

For a more definitive and recent view it makes sense to look at the NICE guidelines. There are two key publications from NICE on this topic: NICE guidelines on Headaches in over 12s: diagnosis and management and the Clinical Knowledge Summary for Migraine. Neither of those publications makes any recommendation in favour of the use of the main treatments provided by chiropractors or osteopaths (manual therapy). If you look into the evidence behind the guidelines in more detail it’s easy to see why. This is what the NICE GDG (Guideline Development Group) had to say: “For migraine, there was one study showing some benefit. The GDG were concerned that the evidence reviewed was of low to very low quality with a lot of uncertainty in the effect estimates, and that rare adverse events may be severe when they do occur. It was agreed that better evidence was required to make a recommendation.”

The NICE guidelines recommend the use of medication-based treatments for the prevention and treatment of migraines. This should be in addition to use of a headache diary as well as providing appropriate information and support. All of these treatments and approaches are available from a GP.

Conclusion

Overall, the lack of research in this area makes it difficult to draw any significant conclusions about the effectiveness of osteopathy or chiropractic for migraines. There is certainly not enough evidence in order to make a recommendation in favour of using these treatments. It makes sense to use the NICE guidelines as the most reliable source of evidence and they recommend treatments that are available from a GP rather than those from a chiropractor or osteopath.  I would summarise the current position as follows:

Based on the currently available evidence there doesn’t seem to be any good reason to recommend osteopathy or chiropractic for the treatment or prevention of migraines.

It would, however, make sense to conduct further research to see whether osteopathy or chiropractic could be of benefit. (The NICE guidelines make a similar recommendation for further research.)

In view of the lack of evidence, it’s surprising that the ASA guidelines allow chiropractors and osteopaths to advertise their treatments for migraines. The ASA guidelines would probably benefit from a review and update based on the evidence that’s available, in particular the NICE guidelines. In the meantime, if you have migraines it is best that you receive evidence-based treatments and these are all available from your GP.

 

Last updated 06/08/19

A recent paper suggests Spinal Manipulation Therapy (SMT) is as effective as recommended treatments for low back pain. Chiropractors celebrate. Should they?

Introduction

Spinal Manipulation Therapy (SMT) is the primary treatment used by most chiropractors and osteopaths as well as being used by some physiotherapists. This study set out to compare Spinal Manipulation Therapy (SMT) with recommended therapies, non-recommended therapies, sham SMT and SMT as adjuvant therapy. It concluded that SMT showed similar benefits to “recommended interventions”. When it was published it was met with trumpet fanfares by a number of chiropractic organisations, as well as others, and claimed as providing strong justification for their treatments. In actual fact it does not do this so let’s explore further.

Summary of conclusions:

1. There are currently no really effective treatments for low back pain.

2. At best, SMT results in a modest average clinical effect. It has also not been shown to be more effective than sham SMT.

3. It’s not currently possible to know whether SMT is safe.

4. It is not currently clear whether SMT is cost effective or not.

5. Taking into account the limited clinical effectiveness and unclear position on safety and cost effectiveness it doesn’t seem to make sense to recommend SMT as a first-line treatment.

Background

Back pain is a widespread problem and SMT is currently listed as a second-line or adjunctive treatment in a number of national guidelines, such as the UK NICE Guidelines as well as the Lancet low back pain guidelines from last year. It’s not recommended as a first-line treatment because current evidence shows it is not sufficiently effective when used alone.

The study and its conclusions

The study was a systematic review and meta-analysis that compared SMT with recommended therapies, non-recommended therapies, sham SMT and SMT as adjuvant therapy. It identified recommended and non-recommended interventions based on guidelines from US, UK and The Netherlands. It’s not clear why these particular guidelines were picked. The Lancet series used a similar set but with Denmark in place of The Netherlands. Perhaps the inclusion of the guideline from The Netherlands is due to the lead author being based there? Whilst it’s understandable that someone will be more familiar and comfortable with guidelines from the country in which they live and work this does introduce a degree of bias into the results and it would be good to see that acknowledged in the paper.

The study concluded that SMT showed similar benefits to “recommended interventions”. It also concluded that SMT vs “non-recommended interventions” shows a statistically but not clinically significant benefit for pain but a statistically and clinically significant benefit for “back specific functional status”. There have been some criticisms, but more on that shortly.

The reaction

A number of chiropractic organisations, as well as others, latched onto this study and claimed it is strong justification for their treatments. Take for instance, this tweet from the British Chiropractic Association:

BCA on Twitter_ _As part of the package of care, chiropractors often _ - twitter.com

It suggests that SMT, the treatment most favoured by most chiropractors, should be considered a first-line treatment for chronic low back pain.

There is also this from the Chiropractic Research Council which includes the comment “supersedes other reviews and publications e.g The Lancet Series which only recommended SMT as a second line treatment option. Groundbreaking stuff!”

As I’ll explain shortly, this review is not particularly “groundbreaking” and the justification for SMT being a first-line treatment is nowhere near as strong as these comments would suggest.

Criticisms of the paper

A thorough and clear critique of the paper was submitted by Mary O’Keeffe and Neil O’Connell. This highlighted a number of issues, including:

  1. SMT was not shown to be better than sham SMT. As this is the only reliable way of assessing efficacy of SMT, it suggests that SMT is not effective as a treatment.
  2. The choice of “recommended” and “non-recommended” therapies was strange and does not align with guidelines. For instance, treatment with paracetamol (which is not recommended by clinical guidelines) was included as “recommended” therapy.
  3. The authors do not seem to interpret their results in line with their own thresholds for determining clinical effectiveness.

The authors submitted a response in which they stand by their original conclusions. They say that SMT cannot be adequately blinded and that therefore trials that compare with other treatments are more valuable than those comparing SMT to sham. In response to point 2 above about choice of “recommended” and “non-recommended” therapies, they say they have undertaken additional analysis taking account of this point and have still arrived at similar results. As far as I can tell, they haven’t responded to the point about thresholds for clinical effectiveness.

Neil O’Connell has sent some further replies on twitter about comparison with sham and the fact that we might see the same minimal benefit for an ineffective treatment:

Neil O'Connell on Twitter_ _Thanks for a considered and thoughtful re_ - twitter.com

It seems likely that this discussion will continue. Hopefully the authors will continue to engage as it’s good to have a healthy debate on complex issues like this. What’s clear is that SMT has not been shown to be particularly effective for low back pain and this new study doesn’t change that.

Safety of SMT

The paper says “About half of the studies examined adverse events (table 2). In most of these studies it was unclear how and whether adverse events were registered systematically; therefore, these data might be unreliable and not accurate for incidence.” In other words: due to a lack of systematic reporting of adverse events, it’s impossible to adequately assess the safety of SMT. The paper does go on to say “clinicians should ensure that patients are fully informed of potential risks before treatment”. This is good advice but I wonder how much this actually happens in practice? Do the main people who carry out SMT (osteopaths, chiropractors and some physiotherapists) ensure that their patients are fully informed of potential risks before they start treatment? Or do they just go ahead and start treatment without doing this?

Cost effectiveness

The paper states “it remains to be determined whether SMT is a cost effective option for the treatment of chronic low back pain.” As more research is needed to assess the cost effectiveness of SMT it would make sense to conduct this research before deciding whether to recommend it as a first-line treatment. If it turns out to be significantly more expensive than other similarly effective treatments then it would not make sense to recommend it as a first-line treatment.

Placing these results in the context of other research

In the section of the paper “Comparison with other studies” it is stated that our results are consistent with other recently published high quality systematic reviews and guidelines that recommend SMT”. I disagree that it is consistent with guidelines, e.g. from NICE, because they have SMT as a second-line treatment option whereas this paper suggests it is as good as currently recommended first-line treatments.

Future research

The paper says “Given the considerable data available, we can now calculate within reasonable certainty the effect of SMT in this setting as well as the impact of a future, methodologically well conducted trial (as determined by the prediction intervals).” In other words, don’t keep doing more similar research in this area because it isn’t going to add anything. This is good advice and is something that researchers should conclude much more often than currently happens. Far too often a study that doesn’t show effectiveness suggests that “more research is needed”. This is a waste of time and money as there is no point in continuing to carry out research when it isn’t going to add anything new.

Conclusions

Overall, this is a decent piece of research and shows fairly similar results to other previous research. It concludes “The evidence suggests that SMT results in a modest, average clinical effect at best”. What’s most strange is not the paper itself but the hype that has surrounded it. There were many “trumpet fanfares” from chiropractic organisations suggesting that this vindicates their treatments and should be used to promote them. It doesn’t actually do this. It shows that SMT isn’t a particularly effective treatment, that it’s not possible to adequately assess its safety and it is not known whether it’s cost effective or not. This is hardly a justification for shouting from the rooftops about how good it is.

What this study does do is add to the body of evidence that indicates that, unfortunately, there remains no good treatment for low back pain. This presents an issue for the many people who suffer with low back pain as there are no really effective treatments. When presented with a number of treatments that are not particularly effective, what is someone with back pain supposed to do? There is no easy answer. However, exercise is known to provide general health benefits and the NHS provides activity guidelines. The importance of these general health benefits should not be understated and is something that SMT cannot provide. In addition, the NICE guidelines recommend exercise as the first-line treatment as well as highlighting the importance of continuing with normal activities as far as possible (self-management). These approaches have the advantage of empowering the patient whereas SMT is a purely passive treatment that does not encourage self-management. I can understand the temptation for someone with back pain to want to go and “get fixed” by seeing a chiropractor, osteopath or physiotherapist who uses SMT. Unfortunately, the evidence indicates that it is not particularly effective and it’s not clear how safe it is. Bearing in mind that it doesn’t provide other general health benefits or empower the patient and is not currently considered a first-line treatment by national guidelines it should probably remain a second-line or adjunctive treatment.