Ad description
A website visited on 1 July 2011, advertised reflexology services. Text on the home page stated “As well as being used to assist in a wide variety of conditions, Reflexology techniques may be used in cases where there are fertility issues (Fertility Reflexology) ... Whilst reflexology does not claim to diagnose, treat or cure a disorder, it is thought that some disorders, detailed below, may respond well to reflexology. This is based mainly on anecdotal evidence and some limited scientific research: - Nervous system - Headaches, Migraines, Insomnia, Stress, Emotional Stress, ADHD, Anxiety, Panic Attacks and Depression; Glandular System - Reproductive - Hormone Imbalances, Menstrual Problems, Menopausal Concerns, PMT, Perimenopause, Fertility Issues, Pregnancy Issues, Prostate Problems; Glandular System - Metabolic - Hormone Imbalances, Thyroid Imbalance, and Adrenal Stress; Circulatory System - Hypertension, Stress, Poor Circulation and Oedema; Respiratory System - Asthma, Hay Fever and Sinusitis; Immune System - Viruses (M.E., glandular fever, Epstein Barr), Cancer, Fatigue, Stress and Auto-immune Disorders such as Rheumatoid Arthritis and Lupus; Urinary System - Hypertension, Water Retention and Backpain; Structural System - Sciatica, Stiff Neck, Muscle Cramps, Tennis Elbow, Toothache and Frozen Shoulder; Digestive System - Indigestion, Heartburn and Stomach Cramps; Intestinal System - Constipation, Poor Appetite and Irritable Bowel Syndrome (IBS); Post operative recovery; Palliative Care and more ...”.
A page titled “Who can benefit from Reflexology” stated “May help to relieve stress - 70% - 90% (estimate) of all illnesses may be caused or aggravated by stress which is likened to a tourniquet around the nervous system. Reflexology may promote deep relaxation which may enable organs and body systems to work more efficiently. - May assist the body to rid itself of toxins - reflexology may assist the body to detoxify. - May improve hormonal and reproductive function - by working the endocrine system reflexology may assist in the balancing of hormones and may help to regulate the menstrual cycle. - May improve blood & lymphatic circulation - reflexology may help to promote improved circulation which may lead to better oxygenation of tissues and greater lymph drainage, helping to maintain homeostasis and boost immune function. - May assist in controlling pain and promoting sense of well-being - reflexology may encourage the release of endorphins the body’s “natural pain killer”. - May assist in balancing all body systems - reflexology may assist in the restoration of health and balance.
A page contained testimonials for The Reflex Clinic, and contained statements such as “Having various problems with my health, I decided to try some alternative therapies, including Reflexology ... I actually felt much better in myself, both physically and mentally” and “I was very pleasantly surprised that it really did greatly improve my depression / anxiety, menopause symptoms and general well-being”.
A disclaimer at the bottom of the home page stated “NOTICE TO READERS & USERS OF OF [sic] THIS WEBSITE. We have done everything possible to make this website compliant with the ASA. We have however, for the purposes of your convenience, left in some medical terms where appropriate as these are the terms that you the user would be searching on and we are therefore unable to remove them because you would no longer be able to find the website using those terms in your google or yahoo search criteria. (We have no control of terminology used by searches). All material on this website is subject to this disclaimer. See the footer link on each page. Reflexology is not intended to replace the relationship with your primary health care providers and the consultation is not intended as medical advice. The consultation is intended as a sharing of knowledge and information from education, research and experience. The information and service provided is not used to prescribe, recommend, diagnose or treat a health problem or a disease. It is not a substitute for medical care. If you have or suspect you have a health problem, you should consult your GP ...”.
Issue
The Nightingale Collaboration challenged whether the:
1. efficacy claims for reflexology were misleading and could be substantiated;
2. disclaimer contradicted, rather than clarified the main text on the website;
3. website discouraged essential medical treatment for conditions where medical supervision should have been sought.
The ASA challenged whether the:
4. efficacy claims in the testimonials could be substantiated.
Response
The Reflex Clinic said they were a reflexology portal, offering reflexologists a fully managed website service, and providing information about reflexology to the public. They said they had 2,000 web pages nationally.
1. The Reflex Clinic said reflexology was a well-established complementary therapy, but there had only been limited research aimed at validating it. They said many of the research projects into reflexology were small due to a lack of funding opportunities, along with a lack of evidence to allow the studies to be set up. They directed the ASA to six studies on reflexology. Of the six, two related to stress and anxiety reduction, three to pain reduction, and one on premenstrual tension (PMT).
2. The Reflex Clinic said they had made amendments to their website when the ASA’s remit was extended to online marketing communications on 1 March 2011. They said they had added more disclaimers across the site, which they hoped would be satisfactory to ensure they were compliant with the CAP Codes. They did not comment on the Nightingale Collaboration’s objection that the disclaimers contradicted the main text on the website.
3. The Reflex Clinic said many reflexologists worked voluntarily within the NHS environment but said they made statements such as “Reflexology works very well alongside conventional medicine. It should never be used in place of seeking medical advice”, which made clear that they were not discouraging individuals to seek medical advice. They also said there were disclaimers at the bottom of each page, and emphasised text that stated “Whilst reflexology does not claim to diagnose, treat or cure a disorder, it is thought that some disorders, detailed below, may respond well to reflexology. This is based mainly on anecdotal evidence and some limited scientific research”. They said they also replaced words such as “can” with “may” and said the word “may” indicated there was a possibility reflexology might help, not that it was a certainty. They said when taken in the context of the entire site they did not believe anyone would be misled or that the site could be seen to discourage individuals from seeking medical advice.
4. The Reflex Clinic said the testimonials were genuine and that they could provide copies if the ASA required.
Assessment
1. Upheld
The ASA noted that four of the six studies submitted (both of the stress reduction studies and two of the pain management studies) were pilot studies, designed as preliminary studies to test methodologies before larger quantitative studies took place. A number of the studies acknowledged the limitations of their findings for that reason, such as a pain reduction study that concluded “Reflexology appears to offer promise as a treatment in the management of LBP (lower back pain); however, an adequately powered trial is required before any more definitive pronouncements are possible”. We therefore considered that we would need to see the results of the larger quantitative studies, and not just the results of the pilot studies, before we could conclude that reflexology was able to assist with stress, anxiety and pain management.
We noted the third pain management study provided was not a pilot study, but also noted it stated that reflexology had no statistically significant effect after three or 24 hours. We therefore considered the study did not provide evidence that reflexology could assist with pain management.
We noted the PMT study was small, with 18 women undergoing reflexology treatment and 17 women undergoing a placebo reflexology treatment as a comparison. We noted the study found a positive link between reflexology and PMT, stating that it found a “significantly greater decrease in premenstrual symptoms for the women given true reflexology treatment than for the women in the placebo group” and “The primary benefit reported by the women receiving true reflexology was the experience of profound relaxation”. We also noted the study stated that it looked at 38 symptoms of PMT and stated that reflexology could benefit both somatic and psychological symptoms, but that it did not specify which of those symptoms reflexology was able to benefit.
We noted that the ASA and CAP had accepted previously that reflexology might help with relaxation, mood improvement, tension reduction and an improved sense of well-being. Those benefits were relevant to PMT symptoms such as poor mood and tension, and we therefore considered that claims that reflexology could have those benefits were acceptable. However, because the study was very small, involved self-reporting by subjects rather than objective measures, and did not specify whether reflexology could benefit symptoms beyond the general benefits we found acceptable, we considered we were unable to accept the study as sufficient substantiation that PMT responded well to reflexology. We considered that stating reflexology could benefit PMT implied it could benefit the more specific or serious symptoms of PMT that women might experience such as depression, anxiety, breast tenderness or cramps, when we had not seen evidence for that.
Because we had not seen evidence that reflexology could provide benefits beyond relaxation, mood improvement, tension reduction and an improved sense of well-being, we considered the efficacy claims for reflexology listed had not been substantiated and were misleading.
The claims 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.
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.
and
12.6
12.6
Marketers should not falsely claim that a product is able to cure illness, dysfunction or malformations.
(Medicines, medical devices, health-related products and beauty products).
2. Upheld
While we noted the disclaimers clearly stated that the site was not intended to prescribe, recommend, diagnose or treat a health problem or disease, we considered they directly contrasted with the claims in the main text of the site, which outlined a large number of serious medical conditions that the site stated reflexology might be able to assist with. We therefore concluded the disclaimers contradicted rather than clarified the main text of the website.
The claims breached CAP Code (Edition 12) rules 3.1 3.1 Marketing communications must not materially mislead or be likely to do so. (Misleading advertising), and 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. Upheld
We noted The Reflex Clinic had ensured the site contained a number of disclaimers and replaced “can” with “may”. We considered that the term “may” still implied reflexology could have some benefit on the conditions listed, when we had not seen evidence that that was the case. We noted a number of the conditions listed in the ad were serious conditions that medical supervision should be sought for such as cancer, depression and auto-immune disorders. We were concerned that by stating reflexology could assist with those conditions, the site might discourage some individuals from seeking medical advice when it was required. As noted in (2) above, we considered the disclaimers on the site contradicted rather than clarified the text, and therefore did not consider the disclaimers were sufficient to ensure individuals were not discouraged from seeking medical advice.
The claims 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.
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.
and
12.6
12.6
Marketers should not falsely claim that a product is able to cure illness, dysfunction or malformations.
(Medicines, medical devices, health-related products and beauty products).
4. Upheld
While we noted the testimonials may have been genuine opinions from clients, we noted we had not seen objective evidence that reflexology was able to have the benefits those clients claimed it could, such as treating depression or anxiety. We therefore concluded that the efficacy claims in the testimonials had not been substantiated.
The claims 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), 3.47 (Testimonials),
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.
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.
and
12.6
12.6
Marketers should not falsely claim that a product is able to cure illness, dysfunction or malformations.
(Medicines, medical devices, health-related products and beauty products).
Action
The claims must not appear again in their current form. We told The Reflex Clinic not to repeat the efficacy claims above that had not been substantiated.
