Background
Summary of Council decision:
Two issues were investigated, both of which were Upheld.
The ASA published an adjudication with regard to the Being in Stillness website on 2 November 2011. The adjudication upheld all ten points of complaint, which were raised by the Nightingale Collaboration, a health claims campaign group, and as a result the advertiser made a number of changes to the wording of their website. We subsequently received a further complaint from the Nightingale Collaboration about that revised wording.
Ad description
Claims on www.being-in-stillness.co.uk, for craniosacral therapy (CST), viewed in November 2011, were headed “(In order to comply with the Advertising Standards Authority following a campaign against complementary health practitioners, I would like to make the following obvious points - This page is a genuine description of my experience and that of many other practitioners and clients of cranio-sacral therapy, rather than being a set of ‘claims’ or a summary of ‘scientific’ evidence. As any user of complementary health will have experienced, the approach to each person in holistic health is individually tailored and complex, and so not easily fitted to mainstream scientific trials, which ask for single definable issues to be separated out from the rest of the person for assessment - in my experience most of us simply do not experience ourselves that way. The mention of certain conditions is not intended to imply or guarantee a ‘cure’ for those conditions, nor any others; and nothing in this website is intended to discourage you from seeking medical advice where applicable)”.
Further text stated “Craniosacral therapy is an extremely gentle and non-invasive way of building health and wholeness and encouraging resolution of issues on any level of our being, whether physical symptoms, emotional traumas, or more subtle aspects of our well-being. Because craniosacral therapy works with our underlying vitality and resources and responds to the individual it may be of help with almost any situation, tending to support our body’s innate healing and self-repair ability and encouraging a feeling of well-being. It is a truly holistic therapy, recognising that a symptom such as a headache may come from many sources, maybe an old injury to a knee that has led to compensation patterns through the body, or habitual stress that causes contraction in the muscles of the neck, affecting blood supply to and from the brain, or countless other possibilities. So in craniosacral therapy we work with the individual, with an awareness of many levels of our being, rather than with conditions as such ... Although outer symptoms may vary, I find a similar process occurring as a fundamental ‘base’ of what happens within a session. From this base we may work with many different situations and conditions - acute and chronic pain, postural imbalance, injuries and strains, whiplash, sciatica; stress, insomnia, depression, anxiety and trauma; low energy and M.E., recurrent infections, digestive problems; migraines and headaches, menstrual disorders, cystitis; dental and TMJ problems, sinusitis, tonsillitis, ear infections; asthma, hyperactivity, autism and learning difficulties; babies’ colic, feeding problems, poor sleep and restlessness. As noted above we are really working with the whole person rather than the conditions (and there are no guaranteed ‘cures’), however most people seeking help are well aware of having a particular issue that they are bringing (and obviously nothing in this website is intended to discourage you from seeking medical advice where applicable). My experience is that this whole-person approach can provide support for all sorts of conditions as they manifest in different individuals, and including our very personal reactions that we all have to any threat to our well-being”.
Further text included “Older people are often taking many pills and are uncomfortable with more invasive therapies. It can be very appropriate and helpful to support the body after perhaps many years of gradually increasing symptoms” and “... After birth, CST may help release the tensions that have been held in the body during pregnancy and the birth process itself, restoring vitality and supporting the habitual postural patterns to normalise again. For Caesarean births, CST may be of help with the stress of the operation on the body, giving it a chance to rest and recover”.
Issue
The Nightingale Collaboration challenged whether the ad:
1. was misleading, because it implied that CST was effective in treating the conditions and situations referenced on the page; and
2. could discourage people from seeking essential treatment for conditions for which medical supervision should be sought.
Response
Being in Stillness (BIS) said that they did not agree with the findings of the ASA’s previous adjudication but had, nonetheless, made substantial changes to their website.
1. BIS said the ad did not state that CST was effective in treating conditions, but rather explicitly stated, twice, that they did not guarantee a ‘cure’ for any ailments. They said the ad also expressly stated their experience that in CST they were not treating conditions but whole people. They said it was therefore not possible for the ad to be taken to imply that CST was effective in treating the conditions listed, because no reasonable person could interpret an explicit statement of not treating conditions as a statement or implication of effective treatment of the named conditions.
BIS said it was highly unlikely that a consumer would be misled by the ad. They said that, for an ad to be found to breach the CAP Code, it would have to be likely to materially mislead the average, reasonably well-informed and circumspect consumer. They said that the average consumer of CST would be aware that there was a general understanding in complementary therapy that no single approach worked for everybody, and they would not be expecting a guaranteed cure; they said the modest language used in the ad did not give a different impression. BIS said such consumers would not expect, or even want, controlled trials as an indication of whether a therapy was likely to be helpful to them, but rather would be more inclined to assess the likely therapeutic relationship with the practitioner.
BIS said the ad emphasised that the information was anecdotal and experience-based, and so visitors to the website would not see the claims as objective and capable of substantiation. They said the ad explained why CST and other complementary therapies were poorly served by, and did not fit, the typical pharmaceutical type of research design because of their whole-person approach, and said that underlined that they were not presenting ‘facts’ that were capable of scientific substantiation. They said that how CST worked was as yet unknown to science and might be a complex interplay of emotional, physical and energetic factors.
BIS provided a number of references to sources which argued that randomised controlled trials (RCTs) were not applicable to complementary health, and which questioned more generally the reliability and usefulness of RCTs in evidencing the efficacy of treatments for individual people in real clinical situations. BIS argued that CAP Code rule 12.1 stated “Substantiation will be assessed on the basis of the available scientific knowledge” and therefore the ASA should take into account such references as part of currently available scientific knowledge and evidence.
2. BIS said they did not offer specific advice, diagnosis or treatment on any condition, but worked with the whole person whatever their diagnostic label. They said the ad expressly stated, twice, that nothing was intended to discourage potential clients from seeking medical advice, and it was therefore impossible that the ad could discourage people from seeking essential medical treatment. They said no reasonable person could interpret those statements as discouraging people from seeing their doctor.
Assessment
The ASA acknowledged that BIS had made amendments to the wording of claims in the ad following our previous adjudication. We noted, however, that some claims and references to conditions which had been found to breach the CAP Code had not been removed from the ad.
1. Upheld
We noted the ad included statements that its contents were based on the experiences of CST practitioners and clients rather than on scientific research, and that the references to specific conditions were not intended to imply or guarantee a cure for those, or other, conditions. We considered the references to conditions and health situations throughout the ad in context with those statements.
We acknowledged the ad made clear that its contents were not claims based on scientific research. However, we considered that, because it referred to its contents as a description of the experiences of practitioners and clients, consumers would understand the references to working with and helping specific named conditions, and more generally with, for example, situations, symptoms, traumas and injuries, to be factual statements relating to the experiences of CST practitioners and clients. We considered that consumers, including those who were familiar with complementary health approaches, would therefore understand those factual statements to be objective claims which were capable of substantiation. We considered that claims relating to experiences were akin to testimonials, and noted that CAP Code rule
3.47
3.47
Claims that are likely to be interpreted as factual and appear in a testimonial must not mislead or be likely to mislead the consumer.
required that claims which appeared in testimonials that were likely to be interpreted as factual must not mislead or be likely to mislead the consumer; we considered such claims must therefore be substantiated. We acknowledged the ad made clear BIS’ views with regard to the use of scientific trials of CST, but we noted CAP Code
12.1
12.1
Objective claims must be backed by evidence, if relevant consisting of trials conducted on people. Substantiation will be assessed on the basis of the available scientific knowledge.
Medicinal or medical claims and indications may be made for a medicinal product that is licensed by the MHRA, VMD or under the auspices of the EMA, or for a CE-marked medical device. A medicinal claim is a claim that a product or its constituent(s) can be used with a view to making a medical diagnosis or can treat or prevent disease, including an injury, ailment or adverse condition, whether of body or mind, in human beings.
Secondary medicinal claims made for cosmetic products as defined in the appropriate European legislation must be backed by evidence. These are limited to any preventative action of the product and may not include claims to treat disease.
required that where relevant, objective claims must be substantiated by evidence consisting of trials conducted on people.
We noted the statements in the ad to the effect that CST did not provide any guaranteed cures, and that the information provided in the ad should not be taken to mean that it could. However, we considered that such statements implied that whilst a cure for a condition was not guaranteed, it was possible that a condition could be cured by CST and, moreover, implied that conditions could be, at the least, alleviated by CST. We also considered that when taken in context with the overall impression created by the ad, consumers might understand that those statements had only been included as a result of pressure from the ASA, following a campaign against complementary health practitioners, and that BIS’s real position was that consumers should understand from their experiences, as well as those of other CST practitioners and CST clients, that CST could help to alleviate or cure conditions.
We noted that statements such as “So in cranio-sacral therapy we work with the individual, with an awareness of many levels of our being, rather than with conditions as such” and “As noted above we are really working with the whole person rather than the conditions” emphasised the approach of CST as a ‘whole person’ therapy, rather than one specifically directed at a presenting condition. However, we considered that the implication of such statements, as well as statements which explicitly stated that CST worked with conditions, such as “From this base we may work with many different situations and conditions” followed by a list of medical conditions, was that CST could help to alleviate or cure conditions.
We noted our previous adjudication highlighted the difference between subjective and objective claims, stating that the wording “... encouraging a feeling of well-being” was a sensory, impressionistic claim and we therefore did not object to it; we acknowledged the amended ad included other subjective statements such as “I feel it is especially significant that [CST] can also engage with our strength and help us in our body-based awareness to begin to remember and honour this in ourselves” and “A cranial session is always a place of honouring where we are right now, and for a new mother that may include just being allowed this time to recognise herself and her motherhood”. However, we also noted that the ad included statements such as “[CST] can be very appropriate and helpful to support the body after perhaps many years of gradually increasing symptoms”, which we considered consumers would understand to be an objective claim that CST could help to alleviate symptoms which had built up over a number of years.
We also noted the ad included statements which we considered combined both subjective and objective statements, and whilst we considered we would not object to the subjective aspects of those sentences should they appear in another context, the aspects which would be understood by consumers to be objective should not appear unless BIS held evidence to substantiate the claim. For example, we considered the overall impression given to consumers by the statement “So in cranio-sacral therapy we work with the individual, with an awareness of many levels of our being, rather than with conditions as such” was that although CST did not necessarily ‘target’ specific conditions or their symptoms, it could still help alleviate conditions or symptoms. However, we considered that if the advertiser removed the final part of the sentence so that it stated only “So in cranio-sacral therapy we work with the individual, with an awareness of many levels of our being” it would be interpreted as a wholly subjective statement and we would therefore not object to it.
We concluded that the references to specific medical conditions, as well as to CST resolving, providing relief of, supporting, helping and working with symptoms, traumas, situations, injuries, stresses, conditions, issues, shocks and tensions, supporting the body’s ability for innate healing, and building and restoring health, were implied claims that CST could help alleviate or cure medical conditions. We reviewed the references to sources which questioned the applicability and usefulness of RCTs as an evidence base for the efficacy of treatments, but understood that current generally accepted scientific opinion was that RCTs were an effective and appropriate way of evidencing the efficacy of drugs and therapies, including complementary health therapies. We therefore considered that health claims in advertising such as those which appeared in BIS’ advertising should be supported by a body of evidence consisting of trials conducted on people, which followed a recognised methodology that controlled for the placebo effect and for other factors unconnected with the proposed action of the therapy as a whole. Because we had not seen such evidence, we concluded the claims were unsubstantiated and misleading.
On this point, the ad breached CAP Code rules
3.1
3.1
Marketing communications must not materially mislead or be likely to do so.
(Misleading advertising),
3.7
3.7
Before distributing or submitting a marketing communication for publication, marketers must hold documentary evidence to prove claims that consumers are likely to regard as objective and that are capable of objective substantiation. The ASA may regard claims as misleading in the absence of adequate substantiation.
(Substantiation),
3.11
3.11
Marketing communications must not mislead consumers by exaggerating the capability or performance of a product.
(Exaggeration),
3.47
3.47
Claims that are likely to be interpreted as factual and appear in a testimonial must not mislead or be likely to mislead the consumer.
(Endorsements and Testimonials) and
12.1
12.1
Objective claims must be backed by evidence, if relevant consisting of trials conducted on people. Substantiation will be assessed on the basis of the available scientific knowledge.
Medicinal or medical claims and indications may be made for a medicinal product that is licensed by the MHRA, VMD or under the auspices of the EMA, or for a CE-marked medical device. A medicinal claim is a claim that a product or its constituent(s) can be used with a view to making a medical diagnosis or can treat or prevent disease, including an injury, ailment or adverse condition, whether of body or mind, in human beings.
Secondary medicinal claims made for cosmetic products as defined in the appropriate European legislation must be backed by evidence. These are limited to any preventative action of the product and may not include claims to treat disease.
(Medicines, medical devices, health-related products and beauty products).
2. Upheld
We noted the ad referred to specific medical conditions, including conditions for which medical supervision should be sought, such as whiplash, depression, migraines, menstrual disorders, TMJ (jaw joint) problems, tonsillitis, asthma, hyperactivity, autism and learning difficulties. We considered that consumers would understand the references to those conditions to mean that CST could alleviate or cure those conditions. We acknowledged that the ad twice included the statement “... nothing in this website is intended to discourage you from seeking medical advice where applicable”. However, we considered that, because consumers would understand that CST could alleviate or cure the named conditions, the references to conditions for which medical supervision should be sought could, nonetheless, discourage readers from seeking essential treatment for those conditions.
On this point, the ad breached CAP Code rule
12.2
12.2
Marketers must not discourage essential treatment for conditions for which medical supervision should be sought. For example, they must not offer specific advice on, diagnosis of or treatment for such conditions unless that advice, diagnosis or treatment is conducted under the supervision of a suitably qualified health professional. Accurate and responsible general information about such conditions may, however, be offered (see rule
12.1
12.1
Objective claims must be backed by evidence, if relevant consisting of trials conducted on people. Substantiation will be assessed on the basis of the available scientific knowledge.
Medicinal or medical claims and indications may be made for a medicinal product that is licensed by the MHRA, VMD or under the auspices of the EMA, or for a CE-marked medical device. A medicinal claim is a claim that a product or its constituent(s) can be used with a view to making a medical diagnosis or can treat or prevent disease, including an injury, ailment or adverse condition, whether of body or mind, in human beings.
Secondary medicinal claims made for cosmetic products as defined in the appropriate European legislation must be backed by evidence. These are limited to any preventative action of the product and may not include claims to treat disease.
).
Health professionals will be deemed suitably qualified only if they can provide suitable credentials, for example, evidence of: relevant professional expertise or qualifications; systems for regular review of members' skills and competencies and suitable professional indemnity insurance covering all services provided; accreditation by a professional or regulatory body that has systems for dealing with complaints and taking disciplinary action and has registration based on minimum standards for training and qualifications.
(Medicines, medical devices, health-related products and beauty products).
Action
The ad must not appear again in its current form. We told BIS not to state or imply that craniosacral therapy was effective in treating conditions until such time as they held robust evidence to substantiate their claims. We also told BIS not to discourage people from seeking essential treatment for conditions for which medical supervision should be sought.
