Challenging misleading healthcare claims

The growing pains of osteopaths

The Advertising Standards Authority has today published new guidance on advertising claims made by osteopaths

Like all other advertisers, osteopaths have to comply with the ASA's CAP Code and the ASA/CAP publish specific guidance to help them — in addition to the more general guidance on health claims and their substantiation.

However, it seems that some osteopaths thought the CAP Code and guidance required some clarification.

Today, the ASA have published even more detailed guidance for those advertising osteopathy services.

This new document provides that clarity and further restricts the claims they can make about the use of osteopathy with pregnant women, children and babies, particularly non-musculoskeletal conditions such as colic and problems allegedly caused by 'birth trauma'.

A cursory glance at osteopaths' websites will find many such claims. See, for example, the results returned by this simple search for colic: osteopathy clinic site:.uk colic. This is a widespread problem.

Initiative

The new guidance is yet another joint initiative by the ASA and the osteopaths' statutory regulator, the General Osteopathic Council (GOsC) to reign in their registrants and they have written to all 4,800 UK of them informing them of the new guidance and the consequences of failing to comply:

The Osteopathic Practice Standards place a duty on all osteopaths to ensure their advertising complies with the CAP Code (Standard D14). Failing to comply with the Code and associated guidance or rulings could result in GOsC fitness to practise proceedings.

The GOsC and the osteopaths' trade body, the Institute of Osteopathy (IO) will be following this up with further communications and articles in various magazines and the GOsC will also be contacting the various osteopathy training organisations to make sure students are fully aware of their responsibilities. We hope that many students will ask questions of their tutors about why they are being taught something they are not allowed to advertise because of the lack of good evidence. Perhaps the GOsC should be asking themselves the same questions and revist their educational requirements.

Claims

There is a lot of work to be done by osteopaths.

For example, the Osteopathic Centre for Children — part of the Foundation for Paediatric Osteopathy whose tag line is "Paediatric osteopathy is the gold standard in holistic healthcare for children" — state:

Babies

An osteopathic check-up following the birth can help pin-point potential problems and helps to ease the dramatic transition from life inside the womb to the outside world. This initial adjustment involves many bodily systems such as breathing and digestion.

Stresses and strains from the labour or pregnancy can lead to unsettled behaviour and difficulties with feeding, winding, bowel movements and sleeping. Relieving any physical strains with gentle osteopathic treatment can be very helpful and relaxing. The care of the entire family unit is of the utmost concern for an osteopath.

Toddlers

This is a time when children learn to crawl, walk, run and communicate and are keen to explore their environment and to interact socially. It is desirable to monitor the progress of these early developmental milestones and to address the effects of any major physical mishaps or developmental lag to prevent problems developing in future.

In many ways these are mild claims; one osteopath's website more worryingly states:

OSTEOPATHY FOR BABIES AND CHILDREN

In the birthing process babies are subjected to enormous forces during their passage through the birth canal. Small amounts of movement exist in the infant skull to permit the baby’s head to adapt to these forces of labour. However when birth is difficult, unduly slow or fast, or complicated by the need for forceps ventouse or cesarean section delivery, the infant head may not fully recover from this distortion. If the baby is unable to resolve the stressors and strains naturally through breathing and suckling, these pressures with in the skull may lead to problems settling, feeding difficulties, disturbed sleep patterns and recurrent infections. Osteopathic treatment using a variety of gentle non invasive techniques may help improve the function of the musculoskeletal system and aid in the reduction of these symptoms.

During childhood, in addition to any earlier trauma or strains the body has to adapt with the growth and development of the bones and muscles. Postural changes and activity level changes with participation in sports can also produce aches and pains which may be eased with manual therapy. Restrictions in the musculoskeletal system can sometimes cause delay reaching developmental milestones for behaviour, speech and learning and may benefit from osteopathic assessment and treatment.

What parent would not be distressed by such stark warnings and sign their new-born up for immediate (and life-long?) treatment?

ASA guidance

Getting back the the ASA's new guidance on osteopathy, it states:

Following a review by CAP of the Bronfort et al Review in 2010, CAP accepts that osteopaths may claim to help a variety of medical conditions, including:

• generalised aches and pains,
• joint pains including hip and knee pain from osteoarthritis as an adjunct to core OA treatments and exercise
• arthritic pain,
• general, acute & chronic backache, back pain (not arising from injury or accident)
• uncomplicated mechanical neck pain (as opposed to neck pain following injury i.e. whiplash)
• headache arising from the neck (cervicogenic) / migraine prevention
• frozen shoulder/ shoulder and elbow pain/ tennis elbow (lateral epicondylitis) arising from associated musculoskeletal conditions of the back and neck, but not isolated occurrences
• circulatory problems,
• cramp,
• digestion problems,
• joint pains, lumbago,
• sciatica,
• muscle spasms,
• neuralgia,
• fibromyalgia,
• inability to relax,
• rheumatic pain,
• minor sports injuries and tensions.

The Bronfort review was commissioned by the General Chiropractic Council (GCC) in 2009 after I submitted 523 complaints to the GCC about claims being made by chiropractors on their websites — the GCC needed the review because they didn't have a clue about the evidence for the claims their registrants had been making. It was little more than a quick literature review carried out by chiropractors in the US.

Even though Bronfort et al. considered all manner of treatments including reflexology, massage and chiropractic manipulations and not just osteopathic techniques specifically, it did look at various paediatric conditions. In terms of the non-musculoskeletal conditions, Bronfort identified a number of systematic reviews and additional RCTs for these conditions. None was positive for any treatment.

However, it only gave results for the treatment of manual therapies for musculoskeletal conditions for adults and is silent on pregnant women, children and babies, so it's quite a leap to extrapolate to those patient groups from adults.

The National Council for Osteopathic Research (NCOR), funded by osteopaths and the GOsC, is currently undertaking a systematic review of manual therapies in the treatment of children and babies. It'll be interesting to see what they finally publish.

Meanwhile, it seems that the ASA believe that osteopaths are trained to treat pregnant women, children and babies and that they should therefore be allowed to make claims about these patient groups, despite being no good evidence that osteopathy is effective for these conditions. This simply raises the question as to what they are being taught if there is no good evidence it is effective for those groups in the first place.

The question of dose response is not addressed either nor the potential for harm — particularly the many claims that it is 'safe and gentle'.

However, that only applies to musculoskeletal conditions: the new guidance prevents them from directly or indirectly referring to conditions such as colic, growing pains, excessive crying and those allegedly caused by 'birth trauma'. As we have shown above, these are frequent claims.

Regulated

Because they are statutorily regulated, the ASA states osteopaths may: 

…refer to conditions for which medical supervision should be sought if they hold convincing evidence of the efficacy of their treatments (Rules 12.1 and 12.2).

The caveat of holding the necessary standard of evidence is important, but it is not clear to us why statutory regulation should confer any special privileges: whilst the Osteopaths Act 1993 does provide for a means of regulating some aspects, it's primarily a means of protecting the title 'osteopath', ensuring registrants are appropriately insured and that there's a code of conduct and a complaints procedure. Notably, the Act does not prescribe any scope of practice, nor proscribe any treatments. This leaves the public open to being misled.

Principles

The new guidance sets out four principles:

Principle 1: Marketing claims

Claims made on osteopaths’ websites that serve the purpose of encouraging consumers to make a transactional decision (i.e. claims that directly or indirectly invite individuals to consider seeking osteopathic treatment for themselves or someone else must comply with the Advertising Code.

Principle 2: References to treating medical conditions

As healthcare practitioners regulated by statute, osteopaths may offer advice on, diagnosis of and treatment for conditions for which medical supervision should be sought. Those claims should be limited, however, to those for which the ASA or CAP has seen evidence for the efficacy of osteopathy for the particular condition claimed, or for which the advertiser holds suitable substantiation (references to conditions which the ASA or CAP accept osteopathy can help with should be understood on this basis, the ASA acknowledges that new evidence may emerge).² The ASA retains the right to ask to review evidence for the purposes of resolving complaints should it consider the need to do so. Osteopaths should therefore ensure that they have access to substantiation before making such claims, including implied claims to treat a particular condition.

Principle 3: Substantiation for treatment claims

Where the efficacy of osteopathy for treating a particular condition has already been established, treatment claims that do not stray beyond the principles set out in the CAP Guidance will be considered compliant with the Code.

Principle 4: Osteopathy for general and specific patient populations

Osteopaths may make claims to treat general as well as specific patient populations, including pregnant women, children and babies provided they are qualified to do so. Osteopaths may not claim to treat conditions or symptoms presented as specific to these groups (e.g. colic, growing pains, morning sickness) unless the ASA or CAP has seen evidence for the efficacy of osteopathy for the particular condition claimed, or for which the advertiser holds suitable substantiation. Osteopaths may refer to the provision of general health advice to specific patient populations, providing they do not make implied and unsubstantiated treatment claims for conditions.

The principles don't say anything new, but the fourth one is important: osteopaths can claim to treat pregnant women, children and babies, but they can only do so in terms of the conditions listed above and it clearly states the conditions they should not claim to treat.

The guidance also gives some examples of claims that are likely and unlikely to be acceptable. The ASA, quite rightly, steer clear of saying outright what is and isn't acceptable: every claim has to be analysed individually in its proper context. We hope that osteopaths will take note of these carefully and not try to take advantage of any perceived equivocation.

Example claims which are unlikely to be acceptable:

• Osteopaths often work with crying, unsettled babies (Implies colic, which is not supported by evidence)
• Birth is a stressful process for babies
• Babies’ skulls are susceptible to strain or moulding, leading to asymmetrical or flattened head shapes. This usually resolves quickly but can sometimes be retained. Osteopathy can help
• If your baby suffers from excessive crying, sometimes known as colic, osteopathy might help
• Children often complain of growing pains in their muscles and joints; your osteopath can treat these pains
• Osteopathy can help your baby recover from the trauma of birth; I will gently massage your baby’s skull
• If your baby is having difficulty breastfeeding, osteopathy might be able to help
• Osteopathy can also play an important preventative role in the care of a baby, child or teenager and bring the body back to a state of balance in health
• In assessing a newborn baby, an osteopath checks for asymmetry or tension in the pelvis, spine and head, and ensures that a good breathing pattern has been established
• Cranial osteopathy releases stresses and strains in the skull and throughout the body
• Osteopaths can feel involuntary motion and mechanisms within the body
• Cranial osteopathy aims to reduce restrictions in movement

It might take osteopaths a while to clean up their websites.

All in the head

The weakest point of the new guidance is what it permits to be claimed about cranial osteopathy/craniosacral technique. It is a frequent treatment of choice by osteopaths for babies and children. Prof Ernst describes it:

Craniosacral therapy (CST), which, confusingly, is sometimes also called ‘cranial osteopathy’, was invented less than half a century ago by an osteopath. He thought that the spinal fluid is pulsating, the cranial bones are sufficiently movable to enable a therapist feel this pulse from the outside, and that it is possible to influence this process with very gentle manual manipulations which, in turn, would restore health in sick individuals. According to the inventor, the CST-practitioner uses his or her own hands to evaluate the craniosacral system by gently feeling various locations of the body to test for the ease of motion and rhythm of the   fluid pulsing around the brain and spinal cord. Soft-touch techniques are then used to release restrictions in any tissues influencing the craniosacral system.

It's entirely fanciful, of course, but many osteopaths seem to believe it is effective for many childhood conditions and is seen by some as the 'bait and switch' used by some osteopaths to get new customers from a very early age.

But at least now they cannot claim that they can feel these movements nor that they can then manipulate the skull to alleviate anything.

Right direction

This guidance is a great step forward. Osteopaths now have absolute clarity about what they can and cannot claim for pregnant women, children and babies and we hope to see speedy changes to websites.

We also welcome the actions taken by the General Osteopathic Council to ensure their registrants stop misleading the public and we hope they will follow through when they are made aware of non-compliant websites; we also hope they will be pro-active in this and not simply wait around for others to submit complaints.

We now hope the ASA and the General Chiropractic Council will now do the same for chiropractors — it is long overdue and, arguably, a much larger problem. The list of allowed chiropractic claims will be shorter, of course, and the list of unacceptable claims longer. Much longer.

02 December 2016

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