Background
Summary of Council decision:
Three issues were investigated, all of which were Upheld.
Ad description
The home page of the website www.arcequine.com, for ArcEquine, seen on 3 August 2017, stated “ArcEquine mimics the body's natural electrical currents and reintroduces them from an external source. Microcurrent Therapy has been used successfully in the treatment of ... Sarcoids … The ArcEquine utilises minute, sub-sensory sequences of electrical current, to provide a drug free, non-invasive and safe treatment, for many injuries and conditions … Disperse Lactic Acid Train harder, recover faster … Increased Cellular Energy … Microcurrent therapy can increase ATP by up to 400% ... Microcurrent Therapy Entirely non-invasive”.
Issue
The complainant challenged whether the following claims were misleading and could be substantiated:
1. “Disperse Lactic Acid”;
2. “Increased Cellular Energy”; and
3. “Microcurrent Therapy has been used successfully in the treatment of ... Sarcoids”.
Response
1. ArcEquine stated that the dispersal of lactic acid related to delayed onset muscle soreness (DOMS), and said that a number of papers had been written on the efficacy of microcurrent therapy in relation to it. They referred to a published paper titled ‘Microcurrent therapy and the treatment of soft tissue injury’, which they stated demonstrated that the use of microcurrent therapy reduced the severity of the symptoms of exercise induced muscle damage.
They referred to another paper titled ‘The efficacy of frequency specific microcurrent therapy on delayed onset muscle soreness’ which concluded that frequency-specific microcurrent provided significant protection from DOMS at all time points tested and that the symptoms of muscle soreness were reduced.
ArcEquine stated that although the studies were carried out in humans, the physiology of humans and horses were similar. They explained that they had also carried out a pilot trial involving horses but they were waiting for the researcher to write them up.
2. ArcEquine stated that it was well documented that mitochondria were present in almost every cell. They produced adenosine triphosphate (ATP), which produced energy from the breakdown of glucose; ATP molecules acted as the energy supply for all cells. They said that the healing process took a large amount of ATP and if the levels of ATP were increased, the immune response and tissue repair were accelerated. It had been proven that microcurrent therapy when used at levels less than 400 microamps could stimulate ATP production by as much as 400%.
They provided a paper which explained the advances in the analysis of bioelectricity and the biochemical effects that occurred in skin tissue. ArcEquine stated that the results after electrostimulation of the tissue showed an increase in ATP concentrations.
They referred to a second paper titled “How Microcurrent stimulation produces ATP”, and stated that the paper explained that microcurrent therapy could significantly increase cellular energy in order to speed up wound healing and other effects such as decreased inflammation, oedema, swelling and increased physical endurance in sports.
They also referred to a study which investigated the effect of microcurrent electrical stimulation applied on injured tendons in rabbits. They stated that microcurrent electrical simulation had gained considerable attention for stimulating soft tissue repair and that the physiological effects of microcurrent electrical simulation related to the promotion of ATP production, increasing amino acid uptake and enhancing secretion of collagen synthesis and tenocytes.
They also referred to a narrative review paper which looked at evidence regarding microcurrent in tissue healing. They stated that the review concluded that microcurrent therapy may have unrealised potential in the treatment of dysfunctional tissue healing. They stated that the application of microcurrent to tissue was found to boost the number of organelles responsible for cellular activities.
3. ArcEquine stated that they had a number of case studies that fully supported that ArcEquine had been successfully used in the treatment of sarcoids. They referred to four case studies featured on their website. They stated that they understood that was anecdotal evidence and suggested amending the claim to state “ArcEquine has been used successfully in the treatment of sarcoids”.
Assessment
1.Upheld
The ASA considered that the claim “Disperse Lactic Acid” would be understood by consumers to mean the technology featured in the ArcEquine device was able to disperse lactic acid build up in the muscles of horses. We understood that microcurrent therapy involved emitting small pulsating currents of electricity into the skin. We considered that in order to substantiate the claim, we would expect to see an adequate body of evidence, consisting of clinical trials conducted on horses using the ArcEquine device.
ArcEquine had referred to three papers, relating to studies carried out on humans and rodents, which looked at muscle soreness and muscle damage. It was suggested that microcurrent therapy reduced the symptoms of muscle soreness and post exercise muscle damage. We noted that one paper concluded that further lab and clinical trials were needed. However, we had not seen any evidence which showed that the ArcEquine device was able to disperse lactic acid in horses. We therefore considered that the evidence provided by ArcEquine was insufficient to substantiate the claim and concluded that it was misleading.
On that point, the claim 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, health-related products and beauty products).
2.Upheld
We considered the claim “increased cellular energy” implied that the ArcEquine device was able to increase cellular energy in horses. We considered that in order to substantiate the claim, we would expect to see an adequate body of evidence, consisting of clinical trials conducted on horses using the ArcEquine device.
The advertiser provided two papers, a review and a study carried out on rabbits which looked at microcurrent therapy and ATP production. We understood that the evidence provided indicated that microcurrent stimulation caused ATP production to increase, and referred to trials carried out on animals. We noted that one paper referred to an in vivo study carried out on the tendons of six ponies via an implanted cathode, but that it did not show any conclusive results.
In the absence of evidence that the ArcEquine device increased cellular energy in horses, we concluded that the claim was misleading.
On that point, the claim 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, health-related products and beauty products).
3.Upheld
We considered that the claim “Microcurrent Therapy has been used successfully in the treatment of Sarcoids” would be understood by consumers to mean that ArcEquine device had successfully treated sarcoids in horses. We would expect to see an adequate body of evidence, consisting of clinical trials conducted on horses using the ArcEquine device in order to substantiate the claim.
We noted that the advertiser referred to four case studies on their website, two of which used ArcEquine in combination with a homeopathic treatment, and all of which reported that the healing period took a number of months. We considered that in the absence of properly conducted clinical trials, the case studies alone did not constitute sufficient substantiation for the claim. We therefore concluded that the claim was misleading.
On that point, the claim 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, health-related products and beauty products).
Action
The claims must not appear in their current form. We told ArcEquine to ensure that they held suitable substantiation to support their claims, consisting of robust clinical trials using the ArcEquine device on horses.
