Summary of Council decision:
Four issues were investigated, all of which were Upheld.
A national press ad for Actegy Ltd, seen on 7 and 14 January and 21 April 2017, advertised the Revitive Circulation Booster for £149.99. Large text stated "REVITIVE ... for fast relief from aching legs & swollen feet!". Smaller text stated "If you suffer with swollen legs, feet or ankles it could be the result of poorer circulation in your lower limbs ... REVITIVE is a drug-free medical device designed to stimulate the muscles in your lower limbs to improve your circulation, which may help to reduce the swelling and, therefore, the pain and discomfort of aching legs, feet and ankles".
A box showed a diagram of a lower leg with blood flowing upwards away from the feet, which rested on the device. Text stated "How REVITIVE technology works to help relieve the pain of swollen feet and ankles ... REVITIVE Circulation Booster is a medical device which uses Electrical Muscle Stimulation (EMS) to contract and relax your leg and feet muscles, to boost the circulation in your lower limbs".
Text in another box stated "READER OFFER - £50 OFF REVITIVE DX ... Call 0800 XXXX XXX quoting [code] for your 30-Day Risk-Free Trial and receive £50 off your new REVITIVE DX ...".
One complainant challenged whether the following claims made for Revitive were misleading and could be substantiated:
1. "... for fast relief from aching legs & swollen feet!";
2. "... may help to reduce the swelling and, therefore, the pain and discomfort of aching legs, feet and ankles" and
3. "... to boost the circulation in your lower limbs".
4. The second complainant challenged whether the claim "£50 OFF REVITIVE", when the product was being sold at £149.99, represented a genuine saving against the usual selling price of the product and could be substantiated.
Actegy Ltd supplied a Clinical Evaluation Report (CER) and user studies. They believed it was appropriate for the ASA to consider both product-specific evidence and the body of evidence contained in the Revitive CER.
1. Actegy proposed to remove "fast" from the claim in future and to make the wording of the claim more conditional.
2. Actegy cited the CER, and also a published study, which they believed supported the mechanism of Neuro Electrical Muscle Stimulation (NEMS) for reducing swelling and providing relief from aching legs, ankles and feet in the patient groups of diabetic peripheral neuropathy, osteoarthritis and following surgery. They said those patient groups were identified in the top right-hand corner of the ad. They acknowledged that electrical stimulation was applied at a level that was sufficient to achieve motor level activation, as opposed to sensory level activation, which was the intent when using transcutaneous electrical nerve stimulation (TENS) machines, but believed there was justification for saying motor level stimulation also provided pain relief through increasing strength; stimulation of local blood circulation; reducing swelling; and increasing functional capacity.
3. Actegy cited the Revitive CER and other documents which included a published study and a paper.
4. Actegy said their policy was to price Revitive DX at £199 on their own website. The "£50 OFF" claim was for customers who purchased via the press ads or through their call centre. Actegy said they ensured that the online price of Revitive DX was at the RRP (£199 price) for at least half of the time, if not the majority. They said most sales of Revitive DX were through other channels, including print ads, and that sales levels at the £199 price were small.
The ASA considered consumers would interpret the ad to mean that if they were experiencing pain or discomfort from swollen or aching legs, feet, or ankles, particularly if they had been diagnosed with osteoarthritis, diabetes, muscle weakness or were recovering from an operation, the Revitive Circulation Booster would boost the circulation in their lower limbs and was likely to help with relieving those symptoms.
Our understanding was that there was adequate scientific evidence that contraction of muscles, achieved either voluntarily or by an external intervention, could have an effect on circulation in the vicinity of those muscles and that a plausible mechanism existed by which electrical stimulation might affect circulation. Whether any such effect was of relevance to the body, however, depended on the size of the contractions, their locations and their duration.
1., 2. & 3. Upheld
The ASA welcomed Actegy's proposal to remove "fast" from the claim "... for fast relief from aching legs & swollen feet" and to make the wording of the claim more conditional. We noted that the Revitive Circulation Booster was a class IIa medical device and that Actegy had supplied a certificate authorising them in the "design and manufacture of electrical muscle stimulators for treatment of circulatory disorders of the lower limbs and transcutaneous electrical nerve stimulators (TENS) for the treatment of pain", which we understood was sufficient to satisfy the requirement that the Revitive was a certified device.
In addition to CE certification from a notified body, we considered it was in any case incumbent on an advertiser under the Code to ensure they held adequate evidence for efficacy claims.
We noted that the ad referred to the Revitive Circulation Booster, Revitive DX, Revitive Medic and Arthritis Knee but that, while the CER referred to a "family of devices", it did not identify any specific models. We understood that all the devices used neuromuscular electrical stimulation (NMES), but also understood that there might be technical differences between different devices which could affect the outcome of the treatment. We considered that for the evidence to be considered adequate, testing needed to have been carried out using the models advertised on the patient groups whom the ad was addressed to. If it had not been, Actegy needed to provide a satisfactory explanation of how and why the devices used in testing and the subjects who participated were equivalent to the devices being advertised and applicable to the patient groups being addressed.
In its analysis of the studies, the CER noted issues such as small sample sizes; the small number of studies showing clinically significant results for the patient groups identified in the ad; and differences between how often and for how long the device was used against what was advised in the ad. In one study, the device had been used once only for four hours. The ad stated, "A typical session lasts from just 20 to 30 minutes", which we acknowledged suggested sessions could last longer than 20 or 30 minutes. However, the ad also stated, "use regularly for maximum benefits" and featured user testimonials which stated, "I believe using REVITIVE every day could help me stay active for longer" and "I use it twice a day". We considered, therefore, that the ad suggested the device was to be used for shorter but more frequent sessions over a longer term and that the results of a study in which the device had been used once only for four hours were likely to be of limited relevance.
The CER also said that the device would provide pain relief as a secondary outcome because of the similarity between the motor level activation it provided as an NMES device and the mode of operation used by TENS devices. However, we considered there were significant differences between devices that functioned as NMES and those that functioned as TENS devices and that it could not be assumed that any effects experienced from TENS would also be experienced from NMES.
In the assessment of the evidence for reducing swelling in the legs, ankles and feet caused by being immobile due to osteoarthritis or an injury, the reviewer found that of five random controlled trials, random sequence generation was adequate in three but that they were judged to have a high risk of bias for participant blinding. Incomplete outcome data was low risk in four; outcome assessor blinding was low risk in two; and all five trials were judged unclear for allocation concealment. The reviewer therefore downgraded the evidence to low quality.
In the assessment of the evidence for improving circulation to reduce or prevent blood-pooling caused by diabetes or by being immobile following surgery, the reviewer found that none of 15 random controlled trials had adequately blinded participants and outcome assessor blinding was judged to be a low risk of bias in only three. Outcome data was adequately reported in nine of these trials. Only one had used satisfactory methods to generate the randomisation sequence while all 15 were unclear in how they concealed allocation. The reviewer said these potential sources of bias downgraded the evidence to moderate quality.
In the assessment of the evidence for reducing pain and discomfort in the legs, ankles and feet caused by diabetic peripheral neuropathy or swelling due to osteoarthritis or following surgery, the reviewer found that in 14 random controlled trials all had a high risk of bias for participant blinding. The reviewer downgraded the quality of evidence to moderate quality.
We noted that in each case, the reviewer had concluded that, despite the issues he had identified and his view that the evidence should be downgraded, there was nonetheless sufficient evidence to support the claims made. However, we considered that the high risk of bias through inadequate blinding in the evidence for each of the claims; the unclear allocation concealment in the evidence for reducing swelling in the legs, ankles and feet; the concern with the methods used to generate the randomisation sequence; and the unclear allocation in the evidence for improving circulation to reduce or prevent blood-pooling were all factors we considered to represent significant limitations to the adequacy of the evidence, given that consumers would make a decision based on the ad to buy the device for regular, long-term use at home.
Of the studies cited separately by Actegy (in addition to the CER), we noted that one featured participants with an average age of 70.8 years. However, the study did not state the age range of the participants. The group was quite small (comprised of 16 males and four females) and appeared to have been conducted for a different purpose – its objectives stated that the aim of the study was to assess the efficacy of a NMES device (the type of device being advertised) in the management of peripheral arterial disease by assessing walking distance – with its conclusion that the device increased the degree to which exercise was tolerated. We noted Actegy's view that the increased distance achieved by the trial participants demonstrated that circulation had improved and that pain was reduced; however, that was not a conclusion stated in the study. We considered the results were, therefore, of limited relevance to the claims being investigated. The study had also not included a control group.
Another study featured 22 participants split between a test group and a sham group. Although it included a control group, the test group was quite small. Participants had a mean age of 62. However, the way in which the groups were split meant that the average age of the sham group was 70 years, with a range of 58–82, while the test group were an average of 54 years, with a range of 41–67. Actegy pointed out that the author of the study stated there was no significant difference in the disease profile of the two groups. We noted Actegy's view that differences in age and BMI would not impact on the changes in circulation and swelling being measured. However, we considered that the usual expectation was that randomisation would lessen the risk of bias. We considered the differences represented significant limitations to the adequacy of the evidence, and that the randomisation was unlikely to be considered reliable.
Another study featured one group of ten and one group of 20 participants, all of who were described as healthy and comprised a group with a mean age of 38.7 years. The age range was 21–64. Although the study concluded that blood flow in the lower limbs was significantly increased by using the Revitive, we considered the relatively young mean age of the participants and the fact that they were all healthy were not sufficient to conclude the effect would be experienced to the same degree by patients in other age groups with the health conditions listed in the ad, to whom the ad was likely to be of interest. The study also did not include a control group.
Because, for the reasons stated, we considered the evidence was not sufficient to support the claims, we concluded that the ad breached the Code.
On points 1., 2. & 3., the ad breached CAP Code (Edition 12) rules
Marketing communications 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).
We considered consumers would interpret the ad to mean that £149.99 represented a £50 saving against the price at which the product was usually sold. We considered, however, that Actegy had not demonstrated that a comparison with the higher price on their website when, by their own admission, most sales were through other channels, and that unit sales at the £199 price were low, was a comparison with the price at which the product was usually sold. We concluded therefore that the savings claim was likely to mislead.
On point 4., 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) and 3.17 3.17 Price statements must not mislead by omission, undue emphasis or distortion. They must relate to the product featured in the marketing communication. (Prices).
The ad must not appear again in the form complained of. We told Actegy Ltd not to make efficacy claims about the Revitive Circulation Booster, for example in relation to relief from pain or discomfort from aching legs and ankles and swollen feet and boosting circulation in the lower limbs, in the absence of adequate evidence. We also told them not to make savings claims unless they could substantiate that the claims represented a genuine saving against the usual selling price of the product.