Osteopaths undertake marketing dressed up as research

Many osteopaths (and chiropractors) use their treatments for babies even though there is no good evidence that these treatments benefit any infant condition. Osteopaths are desperate to find some evidence to support these treatments so that they can promote them more widely. They have therefore undertaken a study called CUTIES, which stands for Crying, Unsettled, disTressed Infants: Effectiveness Study. The first mention I found of this was in an edition of The Osteopath (magazine produced by the regulator, the General Osteopathic Council). There are a number of serious issues with this research that means the outcomes are unlikely to tell us anything about whether osteopathy is actually effective for unsettled babies. Let’s look at these issues in more detail.

Bias

When conducting research, it is inevitable that some level of bias will exist even in the best designed and conducted study. Good researchers work really hard to remove as much bias as possible in order to improve the accuracy of results from their study. However, that is not the case here. The introduction to the study states that the aim is “to build an evidence base for osteopathy in the care of infants”. The researchers are actually setting out to try and provide justification for osteopathic treatment of infants. Research should instead set out to find out IF a treatment works rather than to try and show that it does. This research was therefore deeply flawed before it even started.

Study design, lack of plausibility and “birth trauma” nonsense

This is described as an effectiveness study. This is putting the cart before the horse. Before undertaking an effectiveness study, it is normal to start with a feasibility study to ensure that the treatment is feasible and acceptable to patients. In the published protocol for this study, the authors claim that a pilot trial was conducted to assess feasibility. However, no reference was provided which suggests that it was unpublished. This is a serious concern. Moving to an effectiveness study without first publishing the pilot trial means that it’s not possible for anyone else to assess the basis for the approach used in the effectiveness study (e.g. sample size, recruitment, blinding, etc). This is not the way that good research should be conducted.   

In actual fact the main technique used by osteopaths on babies, cranial osteopathy, is based on a series of illogical unfounded ideas and therefore it is entirely infeasible. Even the protocol for this very trial states “There is little evidence to support the mechanism of action underpinning this approach with the rationale for treatment being theoretically driven”. The reason for the lack of evidence to support the mechanism of action is that it is biologically implausible and makes no sense in the context of a modern understanding of the human body.

Within this protocol paper we also see the same claimed justification for these treatments used by many osteopaths and chiropractors, i.e. “birth trauma”. This is something that isn’t recognised by conventional medicine. That’s because “birth trauma” is something that osteopaths and chiropractors have literally made up in order to try and justify their treatments. It’s not a real thing.

Study hypothesis

The study hypothesis is that “specific targeted osteopathic light touch usual care is superior to non-specific light touch”. The trouble is that is very hard to actually test. In practice, the osteopaths are likely to behave differently (whether intentionally or not) when they deliver the osteopathic intervention. It is this non-specific effect that is the most likely explanation for any difference between the intervention group and control group. In other words, any detected apparent benefit for the osteopathic intervention is very likely to be due to the behaviour of the osteopaths rather than the intervention itself. This doesn’t mean that osteopathy works, just that having the right approach when dealing with patients is important.  

Outcome measures

The outcome measures for this study are: effectiveness of osteopathic care on crying time, confidence in parenting, overall perceived change, and parental satisfaction and experience with osteopathic care. It’s noticeable that these are subjective self-reported measures that are very prone to bias. I’d also suggest that outcome measures such as “parental satisfaction and experience with osteopathic care” have no place in a trial that is intended to measure treatment effectiveness.

Popularity of osteopathic care for babies is very concerning

Although not related to the study itself, the lead for the study suggests that one in every eight / nine infants go to see an osteopath. Personally, I find this very concerning. There is no evidence that osteopathy provides any benefits for any infant condition and osteopaths lack the specialist expertise to treat babies. Any osteopath who is asked see a baby should instead refer them to a more qualified practitioner.

Conclusion

There are many serious issues with this study including an unpublished pilot trial, a treatment approach that lacks plausibility and a biased approach. I would therefore like to make a prediction in which I’m very confident. I predict that this study will produce positive results. How can I possibly know this before the study has been completed? That’s very simple. The study has been designed to generate a positive outcome. It is heavily biased throughout to the point that the person leading the study describes the aim as “to build an evidence base for osteopathy in the care of infants”. Will my prediction turn out to be correct? Let’s wait until the results are published and we’ll see. I’d be very pleased if I was proven wrong because that would indicate a rigorous approach to this research. Unfortunately, I think that’s very unlikely to happen.

Paediatric osteopaths continue to think they can treat a wide range of serious health conditions: This is a risk to the public

Much like paediatric chiropractic, there are many and serious issues with paediatric osteopathy including inappropriate treatment of babies as well as attempting to treat serious health conditions like asthma. The Osteopathic Centre for Children in London, UK, has recently announced a new course for osteopaths. Reading through this I was alarmed by many serious issues, not least of which is that these osteopaths appear to believe that they are doctors. UK osteopaths are not doctors and are instead musculoskeletal therapists very similar to chiropractors. They are not qualified to treat outside of musculoskeletal areas (e.g. back or neck pain) and certainly have no business handling prematurity, maternal mental health or (their words) “the seriously sick child”. The risk of an unqualified person addressing these sorts of serious health conditions cannot be understated. Let’s have a look at this course in more detail.

Course pre-requisites

The only pre-requisite for this course is “Osteopathy in the Cranial Field”. Cranial osteopathy is complete nonsense, conflicts with a modern understanding of the human body and there is no way it could possibly have any health benefit. I am honestly amazed that both osteopaths and the regulator allow cranial osteopathy to continue to be used as a treatment approach. Any course that builds on cranial osteopathy is, by definition, going to be mired in pseudoscience, misleading information and nonsense.

Obstetrics and paediatrics

In medicine, there is a good reason why there are separate specialists in obstetrics and paediatrics. They are very different things, each requiring specialist skills and knowledge. It isn’t reasonable for a single person to be a specialist in both of these areas of medicine. Osteopaths have a different view of this. They seem to think they can become skilled in both obstetrics and paediatrics as the course claims that it will enable osteopaths to develop their “obstetric and paediatric clinical skills”. This is the Dunning-Kruger effect at its finest. These osteopaths understand so little about these areas of medicine that they just don’t realise how little they actually know.

Birth trauma

Osteopaths and chiropractors who treat babies (almost?) always claim that they are treating “birth trauma”. We see this misconception repeated in the description of this course with training being included on “mechanical assisted birth interventions & strains”. In reality, this “birth trauma” is something that chiropractors and osteopaths have literally made up in order to try and justify their treatments. There is no such thing.

Conditions treated

The list of conditions that osteopaths will be learning about on this course is particularly alarming and includes:

• Plagiocephaly (flat head syndrome)
• Feeding issues
• Sleep
• Maternal mental health
• Prematurity
• Behavioural issues
• The seriously sick child (their wording)
• Enuresis (bed wetting)
• Immunity and vaccination
• Orthodontics

Osteopathy, including cranial osteopathy, is not effective for any of these conditions and UK osteopaths (like chiropractors) do not have the specialist expertise required to manage any of these things. In the case of things like immunity and vaccination, all an osteopath needs to know is that they should refer any questions or concerns about this to a qualified medical professional (e.g. GP).

If the idea of osteopaths treating these serious health issues doesn’t cause alarm, how about the idea of osteopaths treating newborn babies in a neonatal ward? Yes, apparently osteopaths on this course will get the opportunity to “treat babies in the Starlight neonatal ward in Barnet Hospital”! I do wonder if Barnet Hospital realise the level of pseudoscientific nonsense they are allowing to be used on newborn babies.

Conclusions

Like paediatric chiropractic, paediatric osteopathy is full of pseudoscience, false beliefs and misleading claims. In this course, UK osteopaths are learning to treat conditions that are far outside of their expertise. The idea of them treating prematurity, newborn babies and “the seriously sick child” is, quite frankly, frightening. The risk that this presents to unsuspecting members of the public cannot be understated. I think that the UK osteopathic and chiropractic regulators need to step in and set a minimum age limit for osteopathy and chiropractic treatment.

Most trials of alternative treatments are fundamentally flawed: an example based on paediatric osteopathy

Much of the research published on alternative therapies is of very poor quality and is often focused on trying to market a therapy rather than actually assessing whether it has benefits or not. There are many issues with the trials conducted in this area and in this post I would like to focus on two key problems:

1. Trialling a treatment for which there is no plausible way it could provide any benefit for the given condition.
2. Trying to show efficacy from a small pilot study.

Getting these two points right is, in my view, beginner level study design. They are often done incorrectly in trials of alternative therapies. Paediatric osteopathy, much like paediatric chiropractic, is mired in pseudoscience and wildly unrealistic treatment claims. I’d like to use this trial of paediatric osteopathy as an example of the points above.

Overview of the study

The title of the study was “Efficacy and Feasibility of an Osteopathic Intervention for Neurocognitive and Behavioral Symptoms Usually Associated With Fetal Alcohol Spectrum Disorder”. The intervention in this case was 4 weeks of osteopathic manipulative treatment (OMT). It was a pilot study with just 32 patients split between intervention (OMT) and a control (standard support measures).

Plausibility

Looking at the first criteria I highlighted above, is there a plausible way that osteopathic manipulative treatment (OMT) could influence neurocognitive and behavioural symptoms? The short answer is a very resounding “no”. There is just no reasonable way that performing manipulations could have an impact on behaviour or the functioning of the brain in any health condition.

It is, however, worth looking a bit more closely at the treatments used in the osteopathic approach to understand just how ridiculous they are. According to the paper “Somatic dysfunctions were detected by physical examination, based on tissue texture changes, asymmetry, limitation in normal range of motion, and tissue tenderness parameters (TART), which guided the osteopathic evaluation and OMT intervention”. Firstly, some degree of asymmetry is normal in everyone and, in spite of claims by many chiropractors and osteopaths, there is no evidence that trying to “correct” this provides any benefit. Secondly, what possible relationship could a limitation in range of motion or tissue tenderness have to behaviour or brain function? This just makes no sense. They go on to say “Using OMT techniques, the identified somatic dysfunctions were corrected one by one in the whole body”. Again, how could any of this possibly have any effect on the symptoms they are trying to treat?

Efficacy and pilot studies

The purpose of a pilot study is to assess feasibility of a treatment approach and understand associated parameters in preparation for a fully powered efficacy trial. A pilot study should NEVER be used to determine efficacy of a treatment. In trials of alternative therapies this very basic rule is often broken with many pilot studies trying to claim that the tested treatment is “effective”. This is exactly what we see with this study: “The main primary objective of this pilot study was to evaluate the efficacy and feasibility of a 4-week planned OMT intervention” (emphasis mine). No, no, no and again no! The authors recognise that this is a pilot study but then claim the primary objective is to evaluate efficacy. If the people conducting a pilot study don’t understand the purposes of such a study they probably shouldn’t be doing the research in the first place!

Other issues

Besides these two very fundamental issues with this study, there are other problems too. For instance, they are trying to develop a treatment for fetal alcohol spectrum disorder. However, in this study they recruited patients that DO NOT have this condition. The patients recruited were “Children aged 3 to 6 years without a FASD diagnosis but with symptoms usually present in FASDs”. If you want to see whether a treatment works for a particular health problem then a pretty basic starting point is recruiting people with that condition.

These sorts of very basic problems are all too common in studies of alternative therapies.

Conclusion

Like many alternative therapies, paediatric osteopathy is mired in pseudoscience and misleading claims. The research conducted into these approaches is often focused on marketing the particular pet therapy rather than genuinely researching it. Using a trial of paediatric osteopathy as an example, I have highlighted two very basic flaws that are common in many studies of alternative therapies:

1. Trialling a treatment for which there is no plausible way it could provide any benefit for the given condition.
2. Trying to show efficacy from a small pilot study.

Studies like this are a waste of time and money and, in my view, are unethical because they involve testing biologically implausible treatments on unsuspecting members of the public. The results from these sorts of trials shouldn’t be trusted and they certainly shouldn’t be used to inform treatment choices.

Just one out of twenty UK osteopathic practices compliant with regulatory advertising guidance

Misleading claims in the UK osteopathic profession has been a serious problem for many years and, in spite of plenty of guidance from the Advertising Standards Authority, continues to be a major issue. I recently assessed compliance of UK chiropractors against the General Chiropractic Council’s (GCC), advertising toolkit for chiropractors. As far as I can tell, there is no equivalent toolkit from the UK osteopathic regulator, the General Osteopathic Council. However, UK osteopaths and chiropractors are very similar professions and the issues with misleading advertising from these two professions are largely the same. I therefore assessed a random sample of twenty London-based osteopaths against the key points from the GCC’s toolkit. Just one out of the twenty was compliant! Overall, the misleading claims were definitely less severe than those from the chiropractic sample I assessed previously, but that isn’t saying much as those results were awful. The problem with misleading claims from UK osteopaths is clearly widespread with some osteopaths suggesting that they can treat serious conditions like asthma (they can’t) or they can treat specialist patient groups like babies (again, they can’t). Let’s look at all of this more detail. 

Selecting the random sample

In order to select the random sample of twenty osteopathic practices, I used the “Search the Register” tool on the General Osteopathic Council’s website. I then entered “London” in the “By postcode or town or county or country” box, left the default of “Within 5 miles” and clicked on “Search”. One difference here is that the search returns osteopathic practices whereas the one from the General Chiropractic Council returns individual chiropractors. I then selected the first twenty osteopathic practices returned by the search. I excluded any practice where I was unable to find a website or the website only had contact info with no description of the practice.

Now you too can easily repeat my search and see for yourself just how bad these osteopathic practices are.

Assessing the osteopaths

As far as I can tell, there is no advertising toolkit from the UK osteopathic regulator, the General Osteopathic Council. However, UK osteopaths and chiropractors are very similar professions and the issues with misleading advertising from these two professions are largely the same. I therefore used the General Chiropractic Council’s advertising toolkit to produce a list of criteria against which to assess the osteopaths, including:

• Advertising for conditions outside of those that osteopaths are allowed to advertise to treat.
• Anti-vaccination stance
• “Correcting alignment”
• Claiming to “treat the root cause”
• Suggesting that long-term care can prevent illness
• Claiming that osteopathic treatment can improve immunity
• Giving the impression that they are a doctor or equivalent to a doctor

Results

Out of twenty osteopathic practices, there was just one who was compliant. I’d like to congratulate Dore Health for being compliant with the regulatory advertising guidance. Unfortunately, the other nineteen practices were not so good. Like chiropractors, the most common issue was advertising to treat conditions outside of the “allowed” list. Seventeen out of the twenty osteopathic practices were in breach of this. For some practices the breaches here were very significant with a wide range of unsubstantiated claims being made for a large number of different conditions. Other common breaches included:

• Claiming to “treat the root cause” – 30% (6 out of 20) made this claim
• “Innate intelligence” – 25% (5 out of 20) made this claim
• Giving the impression that they are a doctor or equivalent to a doctor 20% (4 out of 20) made this claim

Many of the most serious misleading claims from osteopaths were related to the treatment of babies and children. For instance, osteopaths (and chiropractors) claim to be able to treat “birth trauma” such as this from 7 therapies:

Childbirth is not inherently traumatic for babies. The idea of treating “birth trauma” is something that osteopaths and chiropractors seem to have made up in order to justify their wholly inappropriate treatments. In fact, any suggestion of an osteopath carrying out a “check up”, whether for babies, children or adults, should immediately raise alarm bells. UK osteopaths are not doctors and are not qualified to carry out “check ups”.

The use of the term “Family Clinic” often raises significant concern when applied to a chiropractic or UK osteopathic clinic. Take for instance, this from Amberin Fur & Associates Osteopathic Consultancy:

As above, there is no reason a baby needs to be treated “osteopathically” post birth. There is also no evidence that osteopathy will help a child reach their “maximum potential” or help with any childhood complaints.

There were also some osteopathic practices that claimed to be able to treat serious health conditions. One example was Purus Active Health that claimed osteopathy could treat a range of conditions including asthma:

I have written previously about how it is wholly inappropriate, and potentially dangerous, for osteopaths to try and treat respiratory conditions like asthma.

Overall, whilst these results were a little better than for chiropractors, there were numerous and serious breaches of advertising guidelines by osteopathic practices.

Conclusions

UK osteopaths seem to have a better reputation than chiropractors and in England they are even recognised as Allied Health Professionals. However, there are widespread and serious issues with misleading claims and inappropriate treatments throughout the profession. In this random sample of twenty osteopathic practices, just one was fully compliant. A reasonable number of osteopathic practices claimed that they are doctors or equivalent to a doctor and more treated based on “innate intelligence” or treating the “root cause”. Worryingly, a number of the most serious misleading claims were related to babies and children.

It may be possible to find a “good” osteopath. However, in this sample of twenty osteopathic practices just one was compliant with advertising regulations. Whilst this was only a fairly small sample, it suggests that the chances of finding a “good” osteopath is pretty slim. On the basis of these results, it would be hard to do anything other than recommend against seeing a UK osteopath.

UK osteopaths continue to operate far outside their expertise: they now think they can treat autism!

There are many and serious problems with the osteopathic profession in the UK. Even taking this into account, I was shocked and appalled to find that some of them now think they can treat autism. I recently came across the Paediatric sensory integration and GI dysfunction in autistic children course offered by the University College of Osteopathy (UCO). It’s important to remember that UK osteopaths are musculoskeletal therapists rather similar to chiropractors. They are not doctors and treatment of sensory integration, GI dysfunction and autism more generally is completely outside of their expertise. Let’s look a bit more closely at the course, and also the trainer.

The course

The aim of the course is to “give an overview of the signs and symptoms of Sensory Processing Disorders and Autism Spectrum Disorders as well as evidence for possible osteopathic interventions in both subjects”. Let’s be really clear straight away. There are NO osteopathic interventions that have been found effective for sensory processing or autism spectrum disorders (ASD).

The course goes on to suggest the use of “visceral osteopathic techniques on autistic children suffering from gastrointestinal symptoms”. Visceral osteopathy is based on the idea of relieving “imbalances and restrictions in the interconnections between the motions of all the organs and structures of the body”. If that sounds like nonsense, that’s because it is. Visceral osteopathy is implausible and has not been found effective for any health condition. As Edzard Ernst says in one of his posts on the subject: “Visceral osteopathy is not plausible and the best evidence available to date does not show it works. In my view, this means that we should declare it an obsolete aberration of medical history.”

I’m also concerned that the safety of visceral osteopathy has not been adequately assessed. At the very least, a non-medically qualified osteopath poking around in the abdomen of children with ASD has the potential to cause distress. I’m not aware of any research that addresses the potential harms of this treatment.

The trainer

The trainer for this course is an osteopath called Iona Bramati-Castellarin. She runs a private osteopathy clinic called IBC Care based in London. On her clinic website, as well as on Twitter, Facebook and Instagram, she makes a range of misleading health claims including osteopathy for autism, claims related to visceral osteopathy and referring to herself as “Dr”. I complained to the Advertising Standards Authority (ASA) about these misleading claims. They were very quick to respond and said they thought the advertising was likely to be in breach of the Advertising Codes. The ASA have contacted IBC Care and I can see that some changes have started to be made to their website. There is no longer an “autism clinic” on the site, which is good because no osteopath should ever run such a clinic.

Conclusions

This is not the first time that I have highlighted serious issues with the training offered by the University College of Osteopathy. I have written previously about their wholly inappropriate training to osteopaths in The Paediatric Respiratory System. Now they have run a course for osteopaths on the treatment of autism. There are many serious problems here, including:

1. Osteopathy has not been found effective for sensory integration, GI dysfunction or autism.
2. Osteopaths are not qualified to treat any of these conditions, which should instead be handled by a doctor.
3. The safety of some of the techniques being recommended has not been adequately assessed and raises concerns.
4. The trainer for this course was found in breach of advertising guidelines for misleading claims relating to the very subjects being taught.

I have long had serious concerns about the UK osteopathic profession but in attempting to treat autistic children they have stooped to a new low. I don’t doubt that there are some good osteopaths out there who focus on treating musculoskeletal problems in adults and try to be evidence based. Unfortunately, the very deep and serious systemic problems within the osteopathic profession lead me to believe that osteopaths like that are in a small minority. I think the safest option therefore is to not go to a UK osteopath at all and definitely not to take a child to see one! Instead, look for another professional who is better placed to help with your health needs.