A national press ad for Sciaticure, published on 30 July 2016. The ad featured the headline "STOP PAIN RIGHT HERE" and showed an image of a woman with a red line running up her leg and back. Text stated "MODERN BACK PAIN RELIEF … pain-free … The independently tested SCIATICURE Accupressure Wrap is the quick-start to back pain relief ... relieving both short term lumbar pain and ... sciatic pain - AFTER JUST ONE USE! ... the integrated pad places gentle pressure at the top of the calf, breaking the pain signal along the Sciatic Nerve ... effective in back and sciatic pain relief ... NO MORE painkillers for me! ... Breaks pain signals ... Independently tested and proven ... providing sciatic and lumbar pain sufferers with instant relief".
The complainant challenged whether the claims that Sciaticure could provide relief from back pain, and that such relief would be quick, were misleading and could be substantiated.
BioEnergiser Ltd t/a Global Product provided five clinical reports in support of acupressure or acupuncture and pain relief. Three related to pain relief tests of ‘pressure blocks’, where an area of the body was pressed by a fist rather than a finger or other narrow points, as in traditional acupressure. One discussed the relationship between acupressure and ‘pressure blocks’ and the fifth examined the efficacy of acupuncture for sciatic pain. They also provided an article that discussed a paper presented at a conference, which related to a trial of the use of pressure blocks for pain relief.
The ad featured several references to stopping back and sciatic pain, including “STOP PAIN RIGHT HERE!”, “pain-free” and “effective in back and sciatic pain relief” as well as the product name “Sciaticure”. It featured statements relating to the speed of action, such as “the quick-start to back pain relief”, and also stated “NO MORE painkillers for me!”. We noted that this latter claim appeared within a testimonial quote, but considered it would be understood as a factual statement capable of substantiation in relation to the product in general. The ad also stated that the device had been “independently tested”. We considered that, from the ad as a whole, consumers would understand that application of the product would provide immediate, significant relief from back pain and sciatica, comparable with taking painkillers. We reviewed the evidence provided by BioEnergiser.
Of the five clinical papers and conference summary article provided, we noted that none related to the same pressure point (at the top of the calf) used by Sciaticure, and that only one paper related to sciatic or back pain. However, that paper examined acupuncture and did not conclude that it was efficacious. The article briefly mentioned the potential for pain relief for the calf pressure-point, but did not discuss it in detail. One paper discussed whether the use of ‘pressure blocks’ had comparable results with traditional acupressure techniques. It was limited to written discussion only, rather than tests on subjects, and did not conclude that similar results would be obtained by both techniques. Two of the papers, as well as the article outlining the conference presentation, were provided in summary form only and we therefore could not assess the robustness of the trial methodologies. Moreover, none of the papers tested the efficacy of Sciaticure (or any similar device) specifically, or otherwise demonstrated that the interventions tested were directly applicable to the advertised product. None of the papers compared Sciaticure or ‘pressure blocks’ to painkillers. We therefore concluded that the efficacy claims, including the speed of action and the comparisons with pain killers, had not been substantiated and were likely to mislead. In light of the above factors, we concluded that the ad breached the Code.
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.
Claims that are likely to be interpreted as factual and appear in a testimonial must not mislead or be likely to mislead the consumer.
(Endorsements and testimonials) and
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 ad must not appear again in the form complained about. We told BioEnergiser Ltd t/a Global Product not to repeat claims that the device could provide pain relief unless they held documentary evidence to demonstrate that this was the case, including where those claims appeared as part of a testimonial.