Background
On 1 March 2011 the ASA extended its remit to include marketing communications on advertiser’s own websites. Following that extension the ASA has received a large number of complaints about different websites offering craniosacral therapy. The ASA has conducted an investigation to determine the acceptability of the type of claims being made for CST across those websites.
Ad description
Claims on a website, for craniosacral therapy (CST), in May 2011, 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 condition or situation, tending to support our body's innate healing and self-repair ability and encouraging a feeling of well-being ... The body itself guides the practitioner to work in whatever way is appropriate to each individual, always supporting wholeness ... we may work with many different situations and conditions - acute and chronic pain, postural imbalances, injuries and strains, whiplash and sciatica; stress, insomnia, depression, anxiety and trauma; low energy and M.E., recurrent infections, digestive problems; migraines and headaches, menstrual disorders, cystitis, fertility issues; dental and TMJ problems, sinusitis, tonsillitis, ear infections and glue ear; asthma, hyperactivity, autism, epilepsy and learning difficulties; babies' colic, feeding problems, poor sleep, restlessness and failure to thrive ... the practitioner makes gentle contact with the body, 'hearing' these contractions and restrictions with the hands and intuition whilst also feeling the wholeness and potential for health ... Physically, craniosacral therapy can help to relieve postural imbalances, scar tissue, recent and long-standing injuries and strains, both those currently causing symptoms and those which may be basically recovered but leave an underlying weakness and susceptibility ... More serious traumas, whether recent or from long ago, are particularly well helped by craniosacral therapy as it recognises the connections between emotional and physical issues and helps build up sufficient energy and resources to allow gentle resolution ... Older people are often taking many pills and are uncomfortable with more invasive therapies. CST can help relieve aches and pains without any need for manipulation. Energy levels often increase as the body is given a chance to rest deeply after perhaps many years of gradually increasing constrictions and symptoms".
Further claims, under the heading "Babies and Children", stated CST has become known for its gentle yet effective treatment of 'typical' conditions of babies and children such as colic, feeding problems, restlessness, disturbed sleep and recurrent infections ... During birth the baby's head is subjected to strong compressive forces. Particularly with a long or difficult labour, forceps or ventouse intervention, there may be residual effects which need some help to clear. Craniosacral therapy recognises the subtle effects of birth trauma on the still-forming bones of the skull which if left untreated may lead to more persistent problems. Caesarean births present a different set of challenges to the baby, which again can lead to symptoms that may tend to become ingrained if not addressed. For these reasons, it is recommended that babies receive a craniosacral check-up as soon as possible after birth, to allow the best possible start in life ... Children's day-to-day bumps and knocks also respond very well to craniosacral work, again avoiding problems building up over time, so it can be helpful for growing children to have a treatment once every six months or so. Other issues such as failure to recover from infections, or persistent cold or ear infections, are also helped by CST's effect on the drainage of the head as well as support of the immune system and building-up of reserves. It is perhaps unique in its ability to work with the often unrecognised after-effects of meningitis and other infections that can leave lasting and disturbing symptoms such as headaches and restlessness".
Claims under the heading "Pregnancy and Post-natal" stated "Pregnant mothers also benefit from craniosacral therapy, as it tends to balance the whole body and emotions, supporting mother's vitality which inevitably affects the baby and birth process. After birth, CST can help realign the pelvis and release the tensions that have been held in the body during pregnancy and the birth process itself, restoring vitality. For Caesarean births, CST can help with physical recovery of the scar tissue as well as clearing anaesthetic and the stress of the operation from the system".
Issue
The Nightingale Collaboration challenged whether the following claims were misleading and could be substantiated:
1. that because craniosacral therapy "works with our underlying vitality and resources and responds to the individual it may be of help with almost any condition or situation, tending to support our body's innate healing and self-repair ability and encouraging a feeling of well-being";
2. that craniosacral therapy was effective for treating the situations and conditions listed in the ad;
3. that craniosacral therapy could "help to relieve postural imbalances, scar tissue, recent and long-standing injuries and strains, both those currently causing symptoms and those which may be basically recovered but leave an underlying weakness and susceptibility";
4. that "more serious traumas, whether recent or from long ago, are particularly well helped by craniosacral therapy as it recognises the connections between emotional and physical issues and helps build up sufficient energy and resources to allow gentle resolution";
5. that craniosacral therapy could "help relieve aches and pains without any need for manipulation. Energy levels often increase as the body is given a chance to rest deeply after perhaps many years of gradually increasing constrictions and symptoms";
6. that craniosacral therapy could treat the 'typical' conditions affecting babies and children that were listed;
7. the efficacy claims relating to birth trauma and the residual effects of Caesarean birth on the baby;
8. the efficacy claims relating to conditions and illnesses affecting children; and
9. that craniosacral therapy could benefit pregnant mothers and help with the specific pregnancy-related conditions referred to in the ad.
10. The complainant also challenged whether the ad could discourage people from seeking essential treatment for conditions for which medical supervision should be sought.
Response
Being in Stillness (BIS) said they worked within the cranial paradigm, rather than a conventional scientific paradigm. BIS explained that CST worked with the subtle energies of the individual, which represented and seemed to correspond to physical tissues and emotions. Practitioners, experienced in their hands certain sensations, or ‘energy fields’, around the client, which was in turn experienced by the client as subtle movements in the body, or various emotions and insights. BIS said that was a highly subjective experience and each practitioner may experience the work differently.
BIS said consumers who were looking for a CST practitioner were a tiny subsection of the general population, who shared a culture that sat outside of the mainstream and accepted non-scientific phenomena and explanations. BIS argued that such consumers tended to have an interest in complementary health, were of a mindset that recognised mind–body interactions and a holistic approach to individuals, and were interested in building a relationship with their practitioner. BIS said they did not believe such consumers, at whom the website was targeted, would be misled by the ad. They believed those consumers were reasonably well informed, observant and circumspect regarding complementary therapies, and therefore accorded with Office of Fair Trading (OFT) guidelines regarding misleading consumer practices. They argued that it was clear from the website the type of therapy being offered and the philosophy behind it, and that people who did not accept a complementary health perspective were unlikely to look at the site.
BIS pointed out that ‘objective’ was defined as not influenced by personal feeling, or existing independently of perception and measurable by an observer. BIS said the references to situations and conditions on the website used language that was extremely modest, typically talking about “support” or “may help with”, and never claiming “cure” or similar. The purpose of naming those conditions was not to imply that CST could “fix” them, but rather to give a range of circumstances that people often encountered and to reassure consumers that CST practitioners recognised and worked with a variety of situations. BIS said, in addition, the language of the website emphasised that any claims related to a subjective experience and energies, and were unlikely to be understood by consumers interested in complementary health as objective or concretely scientific in any way. BIS said the claims were subjective and experiential in nature and were not able to be scientifically verified or objectively substantiated. They did not believe visitors to the website would regard the claims as objective, but would be looking for a multi-layered approach to their health.
BIS said CST could not be adequately explained or proven by current scientific paradigm or procedure, which did not reflect how CST worked in real life, but that did not mean it was not effective. BIS explained that in recent years doubt had been cast on the use of blinded trials and placebos in research, particularly from within psychiatry and the treatment of depression. BIS said research into complementary health, such as CST, was full of complexities that meant that scientific trials were not applicable to complementary health. For example, CST saw the client as a whole person, rather than a ‘condition’, and assessing the condition alone did not reflect how CST worked in practice. BIS said, in addition, it was impossible to create blinded experiments for CST because, at the least, the practitioner would know which participants received the sham and which the actual treatment, and such a trial would not be able to replicate the relationship between the practitioner and the client. They said there were many non-specific effects of CST, such as empathy and listening skills, and each practitioner had their own style that could not be measured against a standard technique.
BIS said that there was a paucity of research into complementary health in general and CST in particular; it was extremely expensive to carry out research, and independent funding for such projects was limited. They said that existing research into CST showed a positive effect in relation to pain in subjects with fibromyalgia, bladder infections in MS sufferers and quality of life, infantile colic, asthma, tension headaches, and various aspects of dementia. BIS believed the diversity of those conditions supported the experience many practitioners had of the effects of CST that occurred through an integrative approach towards the whole person. BIS said outcome studies had also showed beneficial effects for CST in relation to a range of conditions, such as headache, migraine, neck and back pain, unsettled babies, anxiety and depression. BIS said, for the reasons explained above, the majority of evidence for the efficacy of CST was anecdotal, from practitioners as well as clients, which they believed was the type of evidence a potential consumer of CST would expect. They said their experience was that clients received moderate help from CST, and in a fair proportion of cases clients expressed a huge effect in either their symptoms or quality of life.
BIS provided documentation that discussed the effectiveness and unreliability of blinding and placebos in clinical studies in general, and that discussed their inapplicability for research into complementary health. They also provided documentation that discussed new models of research that might be more accurately used to assess complementary health, and copies of the existing scientific studies and abstracts that had focused on CST, outlined above.
1. BIS said the claim, which referred to “underlying vitality and resources” was open to interpretation, and therefore had no scientific definition and was unlikely to be regarded as objective, although it would be understood by CST practitioners and their clients. BIS argued that the claim referred to a subjective experience and described a subtle, energetic experience, and that “innate healing and self-repair ability” and “feeling of well-being” were non-objective concepts.
2., 3., 4. & 5. BIS said the ad did not claim that CST was effective, but that it might be of help with various conditions; they believed consumers would be aware of that difference. BIS said the context and language of the site as a whole, and in particular the sections in which the named conditions were listed, made it clear that CST was subjective and experience based, and that CST involved energy work of a general supportive nature.
6., 7. & 8. BIS said their response to points 1 to 5 above were also relevant here. BIS said the intention of those parts of the website was to set out the craniosacral paradigm in relation to birth trauma, which was relatively unusual. BIS explained that, in their concept and palpatory experience, many of the problems experienced by young babies seemed to stem from the stresses of birth, which could leave a feeling of fragmentation. BIS said, on reflection, the language related to children and babies could be clearer, and would be amended.
9. BIS said, as explained above, they believed the language and context of the claims relating to pregnant mothers and pregnancy-related conditions were important, and provided sufficient sense of the holistic, non-specific paradigm of CST. BIS argued that, in particular, “benefit” was a subjective and non-specific word, and would not be mistaken for an objective claim by the target audience of the website.
10. BIS said they believed there was nothing on the website that acted either as a direct or indirect discouragement from seeking medical attention, for example the website did not suggest that conventional medicine was ineffective or make comparisons with conventional medicine. BIS believed it was clear that CST was offered as an additional means of support. They said the vast majority of clients saw them as being genuinely complementary to whatever other help they were seeking. BIS provided a copy of research that they said showed that consumers used complementary medicine as an adjunct to, rather than an alternative to, conventional medicine.
BIS said clients were always encouraged to see their GP if they had symptoms that suggested that was necessary and many clients were already also seeking support from their doctor. BIS said their clients tended to come to them in relation to minor aches and pains, or for ongoing general emotional and energetic support. BIS said the Code of Conduct and Standards of Practice issued by the Craniosacral Therapy Association (CSTA), of which they were a member, discussed the need for client referral to a doctor in certain circumstances. They believed all CST training courses also covered the need to recognise if a client was using their CST practitioner as a primary healthcare provider, in order to avoid being drawn into diagnosis, and to ensure clients were referred. BIS said that was basic good practice and ethical practice. CST was not opposed to conventional medicine and wanted the best outcome for their clients. BIS said they would be willing to insert text on the website to make it absolutely explicit that clients should not neglect medical attention.
Assessment
The ASA noted BIS’s argument that consumers interested in CST would not interpret the claims to be objective, but would view them as subjective claims from a complementary health paradigm. We considered, however, that the references on the website to specific named conditions, general trauma, treatment, healing and self-repair were presented as factual statements, and would be understood to be so by consumers. We therefore considered that those claims were able to be substantiated, and should be backed by evidence.
We also noted the discussion papers provided by BIS that proposed different, alternative models for assessing complementary therapies. However, we noted that those papers did not show that the models proposed offered the best available method for assessing the efficacy of CST, or would produce sound results. We considered that the claims in the ad were new claims that should be supported by a body of evidence, consisting of trials conducted on people and following a recognised methodology that controlled for the placebo effect and for other factors unconnected with the proposed action of the therapy as a whole.
1. Upheld
We noted that BIS considered the claim to be subjective. We considered that the reference to “encouraging a feeling of well-being” was a sensory, impressionistic claim and we did not object to it. However, for the reasons given above, we considered that the rest of the claim would be understood as a statement of fact about how CST worked and its ability to treat most conditions. We noted that we had not seen evidence that that was the case, and therefore concluded that the claim "works with our underlying vitality and resources and responds to the individual it may be of help with almost any condition or situation, tending to support our body's innate healing and self-repair ..." had not been substantiated and was misleading.
2. Upheld
We noted that two of the documents provided assessed the effect of CST on urinary tract infections in subjects with MS and on the behaviour of dementia sufferers respectively. We considered that studies carried out on subjects with existing serious medical conditions were not appropriate to support claims relating to the general population. Notwithstanding that, we noted that we had not seen a full copy of the MS study, which did not appear to be controlled or blinded, and that the dementia study was also not controlled or blinded. In addition, we noted that the summary of a study on the effect of CST on asthma did not include the full methodology or results, but again did not appear to be a controlled or blinded trial.
We noted that BIS had provided two discussion documents that related to osteopathy and cranial osteopathic techniques in general and in relation to infant colic in particular, and an abstract of a study on the effectiveness of the CV-4 osteopathic technique on tension headaches. We also noted that we had not seen the full study or results relating to the CV-4 technique, and did not consider that the abstract or discussion documents were suitable to support claims relating to the efficacy of CST.
We noted that one of the studies provided by BIS assessed the effect of CST on pain and heart variability in patients with fibromyalgia. We noted that the study used a control group of patients who were given a sham magnotherapy treatment, compared to the intervention group who received CST, and that both groups received their treatment for the same length of time. However, we also noted that the study was not blinded and that, whilst the CST group received a sequence of treatment covering nine points of the body in each session, the control group were treated on two points of the body only. We considered that the trial had not been adequately controlled and was not suitably robust.
We noted that the final two outcome studies provided by BIS assessed patients’ perceptions of changes in their health during and after a course of CST. In both cases, participants had a range of conditions, including headache, back pain, depression, anxiety, musculoskeletal problems and unsettled babies. We noted that neither study was controlled or blinded, and that in each case participants self-selected the two problems they were seeking help for and self-assessed the level of improvement in those problems; in one study participants were also asked to state the degree to which they felt any changes had related to the CST treatment. We did not consider that the methodology employed in those studies was sufficiently robust to support the claims made in the ad that CST could treat the named conditions.
We considered that we had not seen adequate evidence that demonstrated that CST was effective at treating the conditions or situations listed in the ad, and therefore concluded that it was misleading.
3., 4. & 5. Upheld
We considered that, for the reasons explained in point 2 above, we had not seen adequate evidence that showed that CST was effective for aches and pains or emotional issues. We also noted that the studies provided did not relate to postural imbalances, scar tissue, recent or long-standing injuries, strains and serious traumas or underlying weaknesses, or assessed whether CST could build energy levels or provide deep rest for the body. We therefore considered that those claims had not been substantiated and were misleading.
6., 7. & 8. Upheld
We noted that one of the final two studies discussed in point 2 above included unsettled babies as one of the problems with which participants had self-presented. However, for the reasons explained, we did not consider that that study was sufficient to demonstrate that CST could treat any of the conditions it had assessed. We noted that none of the evidence provided related to birth trauma, the residual effects of Caesarean birth on babies, other conditions and illnesses affecting children. Whilst we acknowledged BIS’s willingness to amend those claims, we considered that the claims had not been substantiated, and therefore concluded that they were misleading.
9. Upheld
We noted that we had not seen evidence that related to pregnancy-related conditions or that demonstrated that CST was beneficial to pregnant mothers. We therefore concluded that the claim had not been substantiated and was misleading.
On points 1 to 9, the ad breached CAP Code (Edition 12) 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) 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 and health-related products and beauty products).
10. Upheld
We noted BIS’s argument that it was clear from the ad that CST was offered as an additional means of support to consumers. However, we considered that the references to the healing, effective treatment of and help with the conditions listed in the ad implied that CST alone was a treatment for those conditions. In addition, we noted that the named conditions in the ad included serious conditions for which medical supervision should be sought, and we concluded that the ad could discourage consumers from seeking essential treatment for those conditions.
On this point the ad breached CAP Code (Edition12) 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 and health-related products and beauty products).
Action
The ad must not appear again in its current form. We told BIS not to claim that craniosacral therapy was effective for treating the conditions referred to in the ad, or to discourage consumers from seeking essential treatment for conditions for which medical supervision should be sought.
