Ad description
The website www.cell-regeneration.co.uk redirected consumers to www.mbst-therapy.co.uk, for magnetic resonance therapy. The website stated "MBST therapy is used to regenerate cells in cartilage, muscle, bone, tendon and ligaments … It can rebuild cartilage and bone cells". Under the heading "MBST Magnetic Resonance Therapy. MBST is used for the management of ...", it stated "Arthritis of the shoulder, elbow, hand and finger joints … Arthritis of the hip, knee, foot and ankle joints, Osteoporosis, Arthritis Cure …".
Issue
The complainant, a surgeon, challenged whether the following claims were misleading and could be substantiated:
1. "MBST therapy is used to regenerate cells in cartilage, muscle, bone, tendon and ligaments"; and
2. "It can rebuild cartilage and bone cells".
3. The ASA challenged whether the efficacy claims for MBST magnetic resonance therapy for the listed conditions were misleading and could be substantiated.
Response
1. − 3. Cell Regeneration Ltd explained that MBST used electromagnetism that selectively acted on particular cells, chondrocyts or osteoclasts, which they said regenerated cartilage or bone. They said that muscle, tendon and ligament regeneration was due to the transfer of energy from the treatment to the bone.
Cell Regeneration said the mechanism was proven by many double blind, clinical studies. They submitted several documents, some of which explained the science behind MBST and additional papers and references which they said supported the claims made in their advertising.
Cell Regeneration said that orthopaedic surgeons and qualified chartered physiotherapists were the only people who allowed patients to undergo MBST therapy, and only after a full assessment, and that when the machines were used by other professional sport clubs, the treatment was supervised by their medical teams. In addition, they said patients in their clinic were supervised by a chartered physiotherapist who was suitably qualified to supervise the treatment. Also, they said that technicians were fully qualified and had spent one week training at the manufacturer's headquarters.
Assessment
1. − 3. Upheld
The ASA noted that the ad made various claims that MBST had a regenerative and rebuilding effect on various physiological structures and also in relation to the relief and cure of arthritis. We considered that consumers would understand that this would mean the outcome of treatment would result in a restorative effect on conditions or symptoms that arose from damage to cartilage, muscle, bone, tendon and ligaments. In addition, based on the claims made, consumers might consider MBST for their arthritis, in particular, the management and mitigation of its progression. Furthermore, the claim that MBST could cure arthritis was likely to lead consumers to understand that the therapy would be effective over and above current treatments provided by a multidisciplinary healthcare team.
We noted the range of professionals that could be involved in the referral and supervision of patients undergoing MBST. While we acknowledged that healthcare professionals would be able to make decisions regarding the appropriateness of a particular therapy regime on a case-by-case basis, we did not consider that this approach was sufficient to support claims for the efficacy of MBST. Because the ad made breakthrough claims for the regeneration of certain body tissues and as an effective treatment or cure for arthritis, we considered that a large body of evidence should exist to support the claims, based on human trials. We acknowledged the range of evidence submitted. However, we did not consider that literature such as promotional brochures, discussion papers or in vitro testing were adequate to support the claims made.
We took expert advice. We noted that none of the clinical trials submitted actually confirmed the reported outcomes with pre- and post-investigation radiological, or other types of clinical investigations and no long-term follow up was conducted to assess whether any potential MBST effect was maintained over time. Other issues with the trials were due to significant methodological flaws. The results from one study was based on retrospective recall of MBST up to four years earlier, one did not include a placebo control, statistical analysis was missing from some trials, and one trial reported what we considered to be an improbable statistical significance. Some of the trials omitted the inclusion and exclusion criteria for participation in the trial, many did not describe the type of arthritis participants had been diagnosed with and their gender was also not recorded. We noted that one trial assessed the effect of MBST on bone mineral density. While it purported to show that in some subjects there was an improvement in bone density, it was not clear whether the results were due to the additional supplementation of calcium and vitamin D3, a common treatment used to help maintain bone density. We considered that these flaws undermined many trial results.
One trial, on the use of MBST for low back pain included participants, some of whom appeared to have had more than one diagnosis for their condition, who all underwent a physiotherapy programme. The trial also included volunteers who had pain originating from the neck and we did not consider any results from their assessment were relevant to a study on low back pain. The results of the trial were positive in some respects for those who underwent active MBST while other outcomes showed improvements in the control group. The trial also showed an improvement in both groups after one week. It was not possible to view all the results in the trial and because the results were mixed we considered this undermined the claim made. Notwithstanding this, we considered that physiotherapy could have played a significant role in the improvement of participants' back pain. Cell Regeneration provided additional studies which also included limitations and methodological flaws. Therefore, based on the body of evidence provided, it was not possible to draw firm conclusions on the effects of MBST.
Furthermore, the studies presented which included follow-up after treatment had ended, were short term and had not assessed whether any claimed effects were maintained over time.
As highlighted above, the studies presented lacked methodological rigour and had not assessed whether the subjects' arthritis disease or the stated body structures were rebuilt or regenerated through means of objective physiological measurements.
Because the evidence submitted had not supported the efficacy claims, we considered the ad was misleading.
On these points, 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),
3.11
3.11
Marketing communications must not mislead consumers by exaggerating the capability or performance of a product.
(Exaggeration) 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).
Action
The ad must not appear again in its current form. We told Cell Regeneration Ltd to avoid making claims that MBST could treat or cure conditions in the absence of suitable evidence and to not falsely claim that the treatment could cure disease.
