ASA Adjudication on Actegy Health Ltd
Actegy Health Ltd
8 Queens Square
Ascot Business Park
11 July 2012
Internet (on own site)
Health and beauty
Number of complaints:
Claims on www.Ultralieve.com promoted an ultrasonic device. Text stated "Symptoms treated" and listed "Arthritic Inflammation, Arthritis & Joint Pain, Back Ache, Back Pain, Bursitis, Carpal Tunnel Syndrome, Chronic Pain, Foot & Ankle Pain ... Headache (Tension), Heel Spur, Hip or Shoulder Capsulitis, Ligament Strains ... Muscle Aches and Pains, Muscle Spasms, Muscle & Tissue Pain, Neck, Hip ... Pains, Neck Strain, Nerve Pain, Nerve Root Pain, Neuralgia, Plantar Fascitis, Post Exercise Recovery, Sciatica, Sports Injuries, Strains, Strains/Sprains, Tendonitis, Tennis Elbow, Trigger Point Pain".
The complainant challenged whether the claims that the device could treat the listed conditions and ailments were misleading and could be substantiated.
CAP Code (Edition 12)
Actegy Health Ltd (previously known as High Tech Health) said they had recently undertaken a review of the clinical evidence to support the indications for use of the Ultralieve PRO. In light of that evidence they said they were in the process of updating the indications for Ultralieve PRO to the promotion of healing soft tissue injuries and the provision of pain relief through thermal and non-thermal physiological reaction. They said the clinical evidence provided was therefore in support of the following indications: neck pain, strain, shoulder pain, joint pain (knee pain, hand pain, wrist pain), muscle spasms, muscle aches and pains and muscle and tissue pain. They stated that they did not seek to substantiate the other conditions listed in the ad, which they said were removed from the website on 6 February 2012, during the investigation.
They provided a clinical evaluation report, together with the literature search protocol, selection strategy, analysis and published articles. They said the report provided a documented systematic critical evaluation of the available evidence of the clinical performance and safety of the Ultralieve PRO ultrasound therapy device, for the purpose of demonstrating conformity with the clinical data requirements. They said the use of 1 MHz therapeutic ultrasound devices had been demonstrated to produce beneficial clinically relevant effects for pain relief and promotion of tissue healing with minimal complications. They said the published data from the studies had demonstrated the capability of 1 MHz therapeutic ultrasound devices to perform satisfactorily for their intended use.
The ASA noted that the advertisers had provided a number of studies and reviews to support their claims, but that the tests and trials had not looked at the effects of the product on some of the listed conditions and ailments. We noted that the website's claims had been amended, but still contained references to some of the conditions and ailments under investigation.
Because we had not seen evidence to support the claims that the device could treat the symptoms of "Arthritic Inflammation, Arthritis ... Back Ache, Back Pain, Bursitis, Carpal Tunnel Syndrome, Chronic Pain, Foot & Ankle Pain ... Headache (Tension), Heel Spur, Hip ... Capsulitis ... Hip ... Pains ... Nerve Pain, Nerve Root Pain, Neuralgia, Plantar Fascitis, Post Exercise Recovery, Sciatica, Sports Injuries, ... Tendonitis, Tennis Elbow, Trigger Point Pain", we considered that those claims were misleading.
We understood that the clinical evidence provided was intended to support claims about the following indications: neck pain, strain, shoulder pain, joint pain (knee pain, hand pain, wrist pain), muscle spasms, muscle aches and pains and muscle and tissue pain.
We sought expert advice. We noted that none of the six literature reviews showed clear or high level evidence in support of the claims. We also noted that the studies provided were not sufficient to support the efficacy of the device in treating the listed conditions and ailments.
Because we did not consider that we had seen sufficient evidence to support the claims that the ultrasonic device could treat the symptoms of the listed conditions and ailments, we concluded that the claims were misleading.
The claims breached CAP Code (Edition 12) rules 3.1 (Misleading advertising), 3.7 (Substantiation), 12.1 and 12.2 (Medicines, medical devices, health-related products and beauty products).
The claims must not appear again in their current form.