Summary of Council decision:
Eight issues were investigated, all of which were Upheld.
A TV ad and claims on the website www.ultralieve.com:
a. A TV ad featured a woman whisking ingredients in a bowl. She suddenly winced and held her shoulder. A voice-over stated, "Life shouldn't stop when pain takes hold" and on-screen text read "Ultrasound may help to temporarily relieve pain of musculoskeletal origin". The voice-over continued, “Ultralieve brings therapeutic ultrasound to your home. Ultrasound is drug-free and commonly used by physiotherapists. Therapeutic ultrasound delivers targeted high frequency vibration that penetrates below the surface of the skin, which may help to relieve your pain." On-screen text stated, "May help relieve pain". The woman shown at the beginning of the ad was shown again, and said "Getting you back to doing what you love". On-screen text stated, "Consult your doctor if symptoms persist".
b. Claims on several pages of www.ultralieve.com. Claims on the home page stated, "Supports the body's natural healing process"; "Treats the source of pain"; and "Helps soft tissue repair". Claims on a page headed "About Ultralieve" stated, "Drug free relief ... Ultralieve doesn't mask pain like painkillers, it supports the body's natural healing process. With Ultralieve, you've found an effective drug-free solution". Claims on a page headed "How Ultralieve works" stated, "Ultimately, Ultralieve helps speed up the healing process by aiding in the transport of essential ions and nutrients to the cell in order to repair the body and relieve pain at the source"; and "Helps Cell Rejuvenation ... The sound waves emitted by Ultralieve stimulate tissue and cells up to 5 cm beneath the skin's surface ... Increasing the properties required for tissue repair helps relieve pain to get you back to your best as quickly as possible".
The complainant challenged whether the following claims were misleading and could be substantiated:
1. the claims in ad (a) that the product could relieve pain;
and the following claims in ad (b):
2. "Supports the body's natural healing process";
3. "Treats the source of pain";
4. "Helps soft tissue repair";
5. "An effective drug-free solution";
6. "Ultralieve helps speed up the healing process by aiding in the transport of essential ions and nutrients to the cell in order to repair the body and relieve pain at the source";
7. "Helps Cell Rejuvenation"; and
8. " Increasing the properties required for tissue repair helps relieve pain to get you back to your best as quickly as possible".
1.– 8. Actegy Health Ltd submitted an expert report that assessed a number of trials and review papers related to ultrasound treatment of various conditions. The report acknowledged that all of the trials reviewed had a variety of methodological issues, including small sample sizes. It stated that the six review papers it considered showed that ultrasound had a positive effect, but had concluded that further research was needed, involving larger patient numbers and more robust methodologies. The report concluded that there was more evidence supporting the use of ultrasound therapy for symptomatic pain relief and to improve joint function than not.
Actegy Health said the on-screen text in ad (a) made it clear that the pain was musculoskeletal in origin, and that that impression was consistent with the pain suffered by the woman in the ad. They said they had compiled a clinical evaluation report, which first established the equivalence of Ultralieve to other therapeutic ultrasound devices and then undertook a systematic review of all the medical literature examining the effects of therapeutic ultrasound for the relief of pain. They said the claim that Ultralieve treated the source of pain was simply an explanation to consumers that the treatment could be applied directly to the soft tissue injury.
Actegy Health said the use of ultrasound for the treatment of soft tissue injuries could speed up the body's natural healing process and that the application of ultrasound had the capacity to stimulate or enhance those normal events and thus increase the efficiency of the healing phases. They said the Ultralieve device did not require drugs in order to achieve efficacy and was therefore "drug free" and the claim "helps cell rejuvenation" was a reference to the use of ultrasound to help soft tissues heal, i.e. cells were healing, repairing or rejuvenating.
They submitted a number of papers in support of the claims.
Clearcast said the script and supporting data for the TV ad were considered by their medical consultant, who acknowledged that ultrasound was used by physiotherapists to relieve pain. They said whether it was 100% effective all of the time had not been established by the supporting data, but the data did, in their expert's opinion, reflect current clinical practice. Their consultant had considered that the claims were borderline, and it was agreed that on-screen text in ad (a) would be added to say, "Ultrasound may help to temporarily relieve pain of musculoskeletal origin". The voice-over and text were also added stating "May help relieve pain", and text stating "Consult your doctor if symptoms persist" was also added. They noted that the ad did not specifically state that the product could relieve pain. They were satisfied that the ad was representative of the product's performance as was likely to be experienced by the user at home.
1.– .8 Upheld
The ASA noted Actegy Health's expert report that concluded that there was more evidence supporting the use of ultrasound therapy for symptomatic pain relief and improving joint function than not. However, we noted that the report acknowledged that all of the trials had methodological flaws or weaknesses, or too small sample sizes, and that the six review papers had consistently concluded that further research was needed involving larger patient numbers and more robust methodologies. The report stated that the body of evidence relating to the use of ultrasound therapy was not ideal, but was all that was available at that time.
We considered that consumers would view the claims in ad (a) to mean that Ultralieve was effective at reducing and resolving general pain symptoms, including musculoskeletal pain. We also considered that consumers would view the claims in ad (b), such as "supports the body's natural healing process", "treats the source of pain", "helps soft tissue repair" and that the device could "relieve pain" to mean that Ultralieve was effective at reducing and resolving general pain symptoms. Therefore, those claims should be based on relevant clinical trials.
We noted that some studies related to carpal tunnel syndrome, myofascial trigger points and pain and knee osteoarthritis. However, those conditions were not referred to in the ads. We also considered that trials related to conditions, such as osteoarthritis and whiplash, which should only be treated under the supervision of a suitably qualified health professional, would not be relevant to an ultrasound device to be used at home by consumers. Furthermore, we identified a number of methodological flaws in the trials, such as some studies not being double-blinded, involving small patient numbers or there only being one treatment session. Additional documents were discussion papers, which we did not consider sufficient to support the efficacy claims. Because of those factors, we considered they were not sufficient to support the claims.
Although the studies covered research on the effects of ultrasound on a number of specific areas of pain, we considered that, because the overall evidence was not conclusive on the effects of the device, and because of the issues identified above, it was not sufficient to support claims about pain relief, including the temporary relief of musculoskeletal pain. We therefore concluded that the ads were misleading and had not been substantiated.
Ad (a) breached BCAP Code rules 3.1 3.1 Advertisements must not materially mislead or be likely to do so. (Misleading advertising), and 3.9 3.9 Broadcasters must hold documentary evidence to prove claims that the audience is 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).
Ad (b) breached CAP Code (Edition 12) rules
Advertisements must not materially mislead or be likely to do so.
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.
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).
The ads must not appear again in their current form. We told Actegy Health Ltd not to make efficacy claims for their products unless they held adequate evidence to substantiate them.