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Bioinduction Ltd t/a Acticare
178 - 180 Hotwell Road
Number of complaints: 1
Date: 19 March 2008
Media: National press
Sector: Health and beauty
A national press ad feature, for an electrical device called Acticare, was headed "The 250 Volt Charge that Relieves Pain by Peter Trueman". It described the experiences of Caroline Harrison, who suffered "constant pain" after a collar bone injury and which "melted away" after she used the Acticare device for an hour. Further text claimed " ... Arthritis pains affect 8 million people in the UK and four out of five adults will experience back pain ... Acticare is a drug free therapy that provides symptomatic relief from many types of pain. Many users have been bowled over by its effectiveness. A survey of 324 patients found that 72% of respondents said their pain levels were reduced by more than half ... Acticare may help provide relief for multiple pains simultaneously ... Tony Eaton, a Backcare helpline advisor comments 'I suffer from bouts of disabling Sciatica, but Acticare helps me get mobile again whenever I have a relapse and has enabled me to live my life again to the full.' ... Acticare is safe to use in the home, but it should not be used to treat undiagnosed pains as it may mask the pain of an underlying condition. We recommend that you consult your doctor before varying your pain medication or for the treatment of anything other than minor aches and pains...".
The complainant challenged whether Acticare could substantiate that the product provided general pain relief and treated the conditions referred to in the ad.
The CAP Code: 3.1;7.1;50.1;50.4;50.7;50.3
Bioinduction said their product was a transcutaneous electrical neurotransmitter (TENS) device, as defined by the statutory bodies the Medicines and Healthcare Regulatory Authority (MHRA) and the US Food and Drug Administration (FDA), that was used to relieve pain. They said the FDA had determined that TENS machines were suitable for the symptomatic relief of chronic, intractable pain and for the management of pain associated with post-traumatic or post-surgical conditions. They said there had been no specific clinical trials conducted on the device, but that a large number of medical papers about TENS devices had been published. They acknowledged that there were differing opinions about the quality of the research amongst academics, but believed there was a growing body of evidence to support the efficacy of TENS. They explained that a patient survey was carried out by an independent consultant on 324 people who used the Acticare device for 3 months. They said 7% of respondents reported "complete" relief and 65% reported "greater than 50% relief" of their symptoms. Bioinduction sent signed letters from Caroline Harrison and Tony Eaton, which confirmed that they had made the testimonials in the ad.
Bioinduction believed TENS therapy was endorsed by the majority of doctors and that 90% of pain clinics in the UK performed TENS therapies. They said 84% of the 362 members of the International Association for the Study of Pain (IASP) surveyed in 2000 considered TENS therapies to be legitimate medical practice. Bioinduction also stated that the core curriculum of the IASP taught that TENS reduced pain in many different types of acute and chronic pain conditions including, for example, low back pain and arthritic pain, and that the regulatory authorities and world-wide clinical practice supported that position. They sent a copy of a paper which they said was the largest meta-analysis conducted on the subject that studied the reduction in painkiller consumption following surgical procedures. The paper showed that, in the 11 trials where an optimal dose of TENS treatment was used, a mean weighted reduction in painkiller consumption of 35.5% was measured compared with a placebo.
Bioinduction provided several quotes from an expert. The quotes said TENS treatments could be used for the management of chronic and intractable pain, lower back pain, nerve-damage pain, sympathetically maintained pain and neurogenic pain. Bioinduction said TENS was used in the treatment of arthritis. They sent a copy of a medical paper which reported on the effect of TENS on pain associated with osteoarthritis of the knee and concluded "TENS and AL-TENS are shown to be effective in pain control over placebo in this review..." and "TENS and AL-TENS over at least four weeks are effective for pain control and relief of knee stiffness in osteoarthritis". In support of TENS relieving acute pain, they sent studies on post-traumatic hip pain and lower back pain during emergency transport. In support of TENS relieving chronic pain, they sent a meta-analysis which they claimed strongly supported TENS as a pain intervention for musculoskeletal conditions in all regions of the body. They referred to several other studies that they had previously submitted to the CAP Copy Advice team. Bioinduction said the MHRA, via their notified body SGS, had approved the device as an "electro-stimulator for pain relief". They said the device had 11 standard modes of operation, eight of which were labelled as TENS and three as TSE (transcutaneous spinal electroanalalgesia). They explained that TSE as inplemented in Acticare was part of the spectrum of TENS waveforms. They sent a report that compared the modes of Acticare with other legally marketed TENS devices.
They said they understood that CAP did not generally accept that TENS could be used to treat chronic pain. They said the ad was based on copy submitted to CAP for approval and that they had worked closely with CAP over a period of weeks. They argued that they were aware of the risk of discouraging consumers from seeking essential treatment and that every customer that ordered products from the helpline was asked if their condition had been diagnosed by their GP. They said they encouraged customers to consult their GP or physiotherapist for advice about use of the product. They pointed out that the ad advised customers to consult their doctor for undiagnosed pains, and for the treatment of anything other than minor aches and pains, and not to vary their medication without advice from their doctor. Bioinduction acknowledged that their device was not always effective and pointed out that that was true of all pain interventions, including painkillers. They said they offered customers a full refund for products returned within 28 days.
Bioinduction said they recently undertook a more rigorous assessment of the efficacy of the device. They sent out two standard validated Brief Pain Inventory questionnaires that they said were widely used in pain studies. The first was enclosed with the device and a follow-up was sent one month later, and both asked people to rate their pain as a Visual Analogue Score (VAS). Bioinduction said their analysis of the 141 results indicated that Acticare was an effective pain intervention when used in the home environment. They explained that people who used the low power TENS modalities showed a reduction in VAS scores of 28%, those using the higher power and higher frequency TSE1 modality a 36% reduction and those using TSE1 centrally over the spine a 43% reduction. They added that they removed all references to Tony Eaton's testimonial and to sciatica in April 2007.
The ASA noted from the Acticare website and from the product specification sent by the advertisers that the device had two modes; one for TENS and the other for TSE. We also noted the ad made claims such as "The ... device generates a high voltage, high frequency electronic pulse that has ten times the power output of TENS machines and penetrates deep tissues, but because of the very short pulses it causes only a mild tingling sensation" and "Unlike most TENS machines where adhesive pads are placed at the site of the pain, Acticare's adhesive electrodes are placed at the top and bottom of your spine for pain originating from legs, hips and back, or at either side of the neck for pain found in the shoulders, arms, neck and head". We considered that those properties appeared to relate to TSE rather than TENS treatment. We noted a similar ad had been submitted to CAP Copy Advice and advice had been given that the product could be advertised within the scope of CAP's accepted claims for TENS devices. We also noted Copy Advice had told Bioinduction that any complaints about the ad were unlikely to be upheld as long as they possessed factual evidence to support their claims.
We considered that, even if it promoted merely the benefits of the TENS mode of the Acticare device, the ad made claims that went further than those generally accepted for TENS. We noted Bioinduction had sent a paper which concluded that TENS was an effective treatment over placebo for pain control and relief of knee stiffness. We also noted the meta-analysis of randomised placebo-controlled trials that showed TENS, and in particular the use of high levels of current, reduced painkiller consumption for post-operative pain. We noted the meta-analysis of TENS in the treatment of chronic musculoskeletal pain. We noted the comments Bioinduction had provided from an expert, but considered that they did not support the efficacy of TENS in treating chronic pain. We understood that TENS devices could be used to treat minor aches and pains, but we also understood that although some studies accepted the efficacy of TENS for pain relief, there was not a general consensus among experts that a sufficient body of evidence existed to substantiate the effectiveness of TENS treatment.
We took expert advice on the evidence sent by Acticare. Our expert commented that the evidence did not support the advertised claims, and that, in general, the evidence on efficacy of TENS in chronic pain, or acute pain, was so weak as not to be supportive of any pain relief claim.
We considered that readers would understand the references to "years of pain", "constant throbbing" and "constant pain" in Caroline Harrison's testimonial to be references to chronic pain and would believe the Acticare device could treat chronic pain. We noted Tony Eaton's testimonial stated "I suffer from bouts of disabling Sciatica, but Acticare helps me get mobile" and considered that readers would understand that the Acticare device could treat sciatica. We considered that, because we had not seen product-specific evidence to show that Acticare could treat chronic pain, sciatica or arthritis, both testimonials were likely to mislead readers. We also considered the patient surveys were insufficient to support the general pain relief claim. Although readers were advised not to use the device for undiagnosed conditions, we considered that the ad implied that Acticare was suitable for treating serious or prolonged medical conditions. We concluded that the ad was likely to mislead.
The ad breached CAP Code clauses 3.1 (Substantiation), 7.1 (Truthfulness), 50.1, 50.3, 50.4 and 50.7 (Health & beauty products and therapies - General)
The ad should not reappear in its current form.
Adjudication of the ASA Council (Non-broadcast)
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