ASA Adjudication on The Microcurrent Site Ltd

Ad

A national press ad, for the Alpha-Stim microcurrent therapy device, was headlined “GREAT NEWS for STRESS, ANXIETY, DEPRESSION and INSOMNIA SUFFERERS”. Text below stated “NON-INVASIVE and DRUG-FREE THERAPY has Arrived!”. Further text stated “It is hard to see how clipping a small electrode to each ear could make you feel calmer, reduce depression or improve sleep, yet the practice of microcurrent therapy has been shown to do all these things and more. … The Alpha-Stim is a non-invasive medical instrument which provides an alternative to drugs, especially in the treatment of disorders that require long-term management … The Alpha-Stim has been shown to offer respite for stress, anxiety, depression and insomnia sufferers for up to 24 hours after wearing for just 30 minutes”.

Issue

1. The complainant challenged whether the efficacy claims in the ad were misleading and could be substantiated.

2. The ASA challenged whether the references to insomnia and depression, which were serious medical conditions, could discourage essential treatment.

CAP Code (Edition 11)

Response

1. The Microcurrent Site Ltd (TMS) said that Alpha Stim products had been in existence since the 1980s.  They were Class IIb medical devices that were manufactured in the US, where they were available on prescription and had been the subject of more clinical trials related to depression than the drug Prozac had been.  They sent two reviews of the use of Cranial Electrotherapy Stimulation (CES), a letter to the editor of a medical journal about CES and a table of studies related to CES.  TMS also sent several articles related to studies that involved CES as well as a study that was conducted as part of a PhD degree.   

2. TMS said they would always advise anyone suffering from clinical depression to consult their GP before using Alpha-Stim.  They also said they would never suggest that a consumer should use Alpha-Stim instead of prescribed medication or therapies without first getting consent from their own GP, because they did not want to discourage essential treatment.  They stated that they were happy to make this clear in future advertising.

Assessment

1. Upheld

The ASA noted that the product was classified in the US.  We also noted that the author of the reviews of evidence provided by TMS was the chairman of a company that manufactured medical devices, including CES devices; he was the designer of Alpha-Stim.  We therefore considered that, although the review had been published, it could not be considered an impartial account of all the evidence available and did not therefore constitute robust substantiation for the claims in the ad.  We also noted one of the reviews stated "this review cannot clearly state that one treatment is better than another due to differences in study methodologies, diagnosis and patient characteristics", which we considered made clear the evidence was not sufficiently robust to substantiate claims about the specific effects of CES.  

We noted that two of the articles TMS sent related specifically to fibromyalgia, which was not referred to in the ad; the other articles suggested that the area was worthy of further research but were related to studies with small sample sizes and/or results that were not statistically significant and/or possibly a result of a placebo effect. The PhD study stated that it was limited because it was not double blinded and made estimations of changes but did not take direct measurements. All of its conclusions were also limited to the immediate effects of a single session of CES and it stated that further research was needed to identify the effect when CES was used over a course of treatment.  We considered that we would need to see more robust scientific studies, that were specific to Alpha-Stim and carried out on a sufficiently large number of human subjects in order to substantiate the claims that it could aid stress, anxiety, depression and insomnia sufferers as stated in the ad. We considered that the reviews sent by TMS did not constitute sufficiently robust evidence.

We considered that the letter to the editor of a medical journal similarly did not constitute robust substantiation for the claims. We also considered that the table, that listed studies on CES in general, did not on its own constitute robust substantiation for such claims. We also noted that a number of studies in the table were carried out on alcoholics and psychiatric patients and considered that those would not be sufficient to support claims for all stress, anxiety, depression and insomnia sufferers.  We concluded that, because we had not seen robust evidence specific to Alpha-Stim to support them, the efficacy claims in the ad were misleading.       

On this point, the ad breached CAP Code clauses 3.1 (Substantiation), 7.1 (Truthfulness) and 50.1 (Health and beauty products and therapies).

2. Upheld

We noted that the ad referred to depression, which was a serious medical condition; it also referred to insomnia and stated that the Alpha-Stim provided an alternative to drugs, "particularly in the treatment of disorders that require long-term management".  We considered that references to ailments such as depression might discourage readers from seeking help from a suitably qualified medical practitioner by implying that the product had curative effects.  We concluded that the ad was irresponsible, because it could discourage consumers from seeking essential treatment for serious or prolonged medical conditions.

On this point, the ad breached CAP Code clause 2.2 (Responsible advertising) and 50.3 (Health and beauty products and therapies).

Action

The ad must not appear again in its current form.  We told TMS not to make claims for which they did not hold robust substantiation.  We also told them not to make reference to prolonged or serious medical conditions in their marketing material.

Adjudication of the ASA Council (Non-broadcast)