Ad description
An ad for Super Inductive System treatment by the Nantwich Clinic, seen in the Nantwich Link magazine in February 2021, featured the claims “Say Goodbye to Pain with the Super Inductive System”, followed by a list of conditions: “Long Term Pain”, “Backache”, “Carpel [sic] Tunnel”, “Ligament and Joint Pain”, “Slipped Disc”, “Fracture healing”, “Nerve Damage” and “Sprains”. Three images of someone receiving treatment with the Super Inductive System appeared underneath, followed by further text which stated “IMMEDIATE AND LASTING PAIN RELIEF for all stages of disorder, Chronic or Acute”. A phone number and website URL appeared underneath, alongside the Nantwich Clinic logo.
Issue
The complainant challenged whether the efficacy claims for the medical conditions listed in the ad were misleading and could be substantiated.Response
Cheshire Health & Medical Professionals LLP t/a Nantwich Clinic said that the product offered people living with pain an alternative treatment to pain killers.They provided a link to the supplier’s website for further information about the product and some introductory information about the Super Inductive System. They also provided one published paper and five unpublished papers.
Assessment
Upheld
The ASA considered that consumers would understand from the claims “Say Goodbye to Pain with the Super Inductive System”, “Long Term Pain”, “Backache”, “Carpel [sic] Tunnel”, “Ligament and Joint Pain”, “Slipped Disc”, “Fracture healing”, “Nerve Damage” and “Sprains”, and “IMMEDIATE AND LASTING PAIN RELIEF for all stages of disorder, Chronic or Acute” to mean that the Super Inductive System could provide immediate and lasting relief from any type of chronic or acute pain. This would also include specific types of, and sources of, pain such as backaches, a herniated disc, carpal tunnel syndrome, joint and ligament pain, fractures, nerve damage and sprains. We also considered that consumers would interpret “fracture healing” to mean that the product could help to repair fractures. In the absence of information to the contrary, we considered consumers would understand that the treatment was intended for use in individuals who did not have other underlying conditions in addition to the disorders listed.
We understood that the Super Inductive System comprised a coil which generated a high-intensity pulsed electromagnetic field and was designed to interact with the human body and cause chemical changes in the nerves and muscles to help them relax. We understood that the treatment with this equipment was being offered on site at a clinic.
We considered the evidence provided by the Nantwich Clinic. The first study was unpublished and examined the effect of high-intensity electromagnetic field stimulation on 30 post-stroke patients, randomized into two groups. The study investigated the effect of the product on muscle spasticity (involuntary tightening) rather than pain, in a specific subset of patients who had experienced stroke, and therefore was not relevant to the claims in the ad.
The second study was unpublished and described case studies of six patients with wrist fractures who were delivered a course of ten therapies with the system. Outcomes were measured by specialists through X-ray imaging, as well as through a Patient Functional Assessment Questionnaire (PFAQ) which evaluated the performance of basic home activities. According to the X-ray imaging specialist, three of the patients showed excellent callus formation and the other three showed good callus formation. According to the PFAQ, patients showed over 40% improvement as a sum of all indicators and all patients reported that the therapy had relieved their pain. However, the study was uncontrolled and with a very small sample size. We did not consider it was sufficient to support the claims in the ad that the therapy could aid “fracture healing” or relieve any type of pain.
The third study was unpublished and examined the effect of the product in a patient with acute epicondylitis which affected the elbow joint and who also had chronic shoulder girdle pain. While the results reported some improvement in elbow joint and shoulder girdle pain following the use of the product, we considered that an uncontrolled case study of a single patient was insufficient to support claims that the therapy could relieve elbow or shoulder joint pain.
The fourth study was unpublished and examined the efficacy of high intensity electromagnetic field in strengthening breathing muscles and treating musculoskeletal disorders in central motor impairment. The paper again described a single uncontrolled case study, and in any case the outcomes measured were not relevant to the claims made in the ad.
The fifth study was unpublished and included 57 randomly selected patients with chronic and acute musculoskeletal pain. Patients had six rounds of therapy on average. The results showed a significant release of pain with 46 patients, with no effect on four patients, and seven patients were excluded from the study. The outcomes were evaluated based on the subjective statements of the patients before and after each therapy. The results of the study showed that the overall decrease of pain was 37.5%. However, the study was not blinded or placebo controlled, and we therefore did not consider it was sufficient to substantiate that the therapy could provide relief from acute and chronic pain.
The sixth study was published and evaluated the effectiveness of the product in treating muscles with damaged innervations. Thirty patients were randomized into treatment and control groups. The treatment group received Repetitive Peripheral Inductive Stimulation (rPIS) therapy which used a high intensity electromagnetic field. The control group received electrotherapy. Manual Muscle Testing (MMT) and PFAQ were applied at both pre- and post-treatment stages. The outcomes showed that the level of improvement from MMT examination was 67% in the treatment and 47% in the control group. The PFAQ results showed improvements in all domains for the treatment and control group. While the results were reported to be statistically significant, we understood that the study measured muscle strength through mobility in everyday tasks such as walking, bending, sitting and carrying objects and was therefore not directly relevant to assessing pain relief.For the reasons set out above, we considered that the claims “Say Goodbye to Pain with the Super Inductive System”, “Long Term Pain”, “Backache”, “Carpel [sic] Tunnel”, “Ligament and Joint Pain”, “Slipped Disc”, “Fracture healing”, “Nerve Damage” and “Sprains” and “IMMEDIATE AND LASTING PAIN RELIEF for all stages of disorder, Chronic or Acute”, as consumers were likely to understand them in the ad, had not been substantiated and were therefore misleading.
The ads 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 ad must not appear again in the form complained about. We told Cheshire Health & Medical Professionals LLP t/a Nantwich Clinic to ensure that they did not state or imply that the Super Inductive System could provide immediate and lasting relief from pain in general, or from pain resulting from any of the sources listed in the ad, unless they held adequate evidence to substantiate their claims.
