A regional press ad for Eileen Mannion Acupuncture, seen in HD Connect magazine on 6 May 2017, included text which stated “Eileen offers acupuncture for fertility support, musculoskeletal problems, headaches, migraines, insomnia, anxiety & other conditions.”
The complainant challenged whether the efficacy claims for acupuncture for fertility support, musculoskeletal problems, headaches, migraines, insomnia, anxiety and other conditions were misleading and could be substantiated.
Eileen Mannion Acupuncture said there was a growing evidence base for the efficacy of acupuncture and recognition by professional bodies. They suggested that evidence was continually changing and that the CAP advice was no longer in line with the National Institute for Health and Care Excellence (NICE) guidelines. They provided a body of evidence in support of the claims, which included links to websites, abstracts and summaries of studies and full research papers accompanied by explanations detailing how those were relevant to the claims.
The ASA acknowledged that the advertiser did not use terms such as “treat” and “cure”. However, we considered that consumers would understand the claim “Eileen offers acupuncture for …” to mean that acupuncture could help improve, or cure, the conditions listed. We also considered that, in the absence of information to the contrary, consumers would consider that effect would be lasting.
We had previously assessed evidence and accepted that acupuncture could be said to provide short-term: improvement in the symptoms of overactive bladder syndrome (through electro-acupuncture at the SP6 point); relief of tension type headaches; relief of migraine headache; relief of chronic low back pain; relief of neck pain or chronic neck pain; and relief from temporomandibular (TMD/TMJ) pain; and temporary adjunctive treatment for osteoarthritis knee pain. We acknowledged that the ad referred to some of those listed conditions, specifically, headaches and migraines. However, we did not consider that the ad qualified the claims, by stating the relief would be short term or temporary.
We considered that the claim regarding musculoskeletal problems was broad and implied that acupuncture could help improve or cure a range of conditions that fell into that category. We noted, however, that the only musculoskeletal problems that we had previously accepted that acupuncture could provide some relief for were temporomandibular (TMD/TMJ) pain and osteoarthritis knee pain.
We considered the body of evidence supplied to us by Eileen Mannion. We considered the supplied literature which summarised other studies did not provide sufficient detail regarding the subjects and methodology, and that the abstracts supplied did not provide the requisite level of detail needed for us to assess the robustness of the studies referred to.
The advertiser provided a 2003 WHO published report which had evaluated clinical trials concerning the effectiveness of acupuncture. The author stated their intention was to provide a review and analysis of controlled clinical trials of acupuncture therapy, as reported in the current literature. The report collated a wide range of research and we considered the report amounted to a review of the literature relevant at the time. While the author considered the research design and other measures of robustness for each study, we considered there was not sufficient detail about the individual studies for us to draw similar conclusions. Furthermore, we considered many of the author’s conclusions about the respective studies lacked detail for the purpose of substantiating health claims. The report also set out an exclusive list of diseases, symptoms or conditions for which the report’s author understood had proved, through controlled trials, that acupuncture was an effective treatment. The only listed condition relevant to the ad was headache. For the reasons set out, however, we considered we would have needed to see the relevant studies to determine their adequacy as substantiation. The report also set out an exclusive list of diseases, symptoms or conditions for which the therapeutic effect of acupuncture had been shown, but the report’s author understood that further proof was needed to demonstrate the efficacy of acupuncture in treating those listed conditions. None of those conditions were ones for which we had previously accepted treatment claims for acupuncture, and we did not consider that the report alone was sufficient substantiation for claims that acupuncture could treat those conditions.
The advertiser had also provided a link to the NHS website that set out the NICE guidelines that referred to acupuncture. The website stated the NICE guidelines only recommended considering acupuncture as a treatment option for chronic tension-type headaches and migraines. The website had also listed that acupuncture was used for musculoskeletal conditions and pain conditions, including chronic pain, such as neck pain, joint pain, dental pain and post-operative pain, but the website did not make a statement about acupuncture’s efficacy. The website then qualified that and said, “… however, the guidelines stated that there was less good quality evidence to draw any clear conclusions over acupuncture’s effectiveness for those conditions compared with other treatments”. For the same reasons, we did not consider that subsequent list of conditions had been adequately substantiated based on the website’s description of the guidelines alone.
The advertiser also sent evidence relating to studies of acupuncture as a treatment for migraine and headache. A website entry had reviewed the literature on the effectiveness of acupuncture for migraine and headache, but little information was provided about studies relied upon, including the respective methodologies. We, therefore, considered that without that further information we were not able to assess the robustness of the literature and the conclusions drawn. The advertiser also supplied a 2016 Cochrane review. That review was an update on a review undertaken in 2009 which had been considered as substantiation in a previous ASA investigation during which we had sought the opinion of an expert. The expert concluded that the 2009 review of trials of acupuncture for migraine prophylaxis demonstrated that acupuncture provided relief from migraine attacks, and there was some evidence that it may also be preventative. We had previously concluded that this evidence therefore supported claims that acupuncture could provide short-term relief of migraine headache only. The 2016 review concluded that since the 2009 review only one new small, sham-controlled trial had become available, so their findings had remained largely unchanged. Therefore, we considered our previous conclusion remained valid.
We concluded that because the claims in the ad referred generally to headache and migraine rather than specifically to tension-type headache and did not make clear that relief of the conditions was short-term, the implied claims had not been substantiated and were therefore misleading.
The advertiser sent papers relating to studies of acupuncture as “fertility support”. That included a published and peer-reviewed meta-analysis of seven trials which explored the effects of acupuncture on rates of pregnancy and live birth among women undergoing in vitro fertilisation (IVF). That paper concluded that current preliminary evidence suggested acupuncture given with embryo transfer improved rates of pregnancy and live birth with women undergoing IVF treatment. We did not consider that the study was directly relevant to the claim in the ad which concerned fertility, which was a broad term, and we noted the scope of the claim had not been limited to suggest acupuncture could improve pregnancy rates in women undergoing IVF treatment. We considered that because that was the only paper provided in support of that broad claim, the claim had not been substantiated and was therefore misleading.
We acknowledged that the advertiser was currently undergoing training, provided by the NHS, to become a registered acupuncturist with Anxiety UK and that Anxiety UK were undertaking a project to explore the effectiveness of acupuncture as a treatment for anxiety. While the ambition of the project was to build a body of evidence that measured the success rate of that type of treatment, until the time that such a body of evidence existed we considered that this did not amount to adequate substantiation. The advertiser also provided a paper relating to a study of acupuncture as a treatment for anxiety. The study specifically addressed whether auricular acupuncture could be introduced as a treatment for anxiety before surgery and concluded that there was some short-term effect, although this could not be attributed to any particular mechanism. The authors also acknowledged that it was a small study and that further evidence was necessary. Notwithstanding that, we did not consider that the study was directly relevant to the claim in the ad which concerned anxiety generally, and therefore concluded the claim had not been substantiated and was therefore misleading.
The advertiser sent a paper relating to studies of acupuncture as a treatment for insomnia. That meta-analysis had been reviewed as substantiation in a previous case. In that case we concluded the review called for further trials and, furthermore, were concerned with its methodological rigour. It included five unpublished graduate dissertations, the majority of included randomly controlled trials were rated as having only a 'fair' methodological quality, and only eight of the included trials had any form of blinding. We concluded the methodology of the study was not sufficiently robust for its conclusions to be used to support advertising claims that acupuncture could help with insomnia or sleep disturbances.
The advertiser sent papers relating to studies of acupuncture as a treatment for musculoskeletal problems. One paper was a literature review that concluded there may be some evidence that acupuncture has a place in the treatment of chronic musculoskeletal pain. The review also said acupuncture clearly cannot provide a ‘cure’ but can provide symptomatic relief and should be considered as a part of any pain management programme. We noted of the 13 studies reviewed, only six demonstrated any efficacy. Nevertheless, we considered there was insufficient detail in the paper about the methodological quality of the studies for us to make an assessment as to their robustness. Therefore, we did not consider that that paper and the conclusion therein alone substantiated the claim made in the ad. Another paper related to the efficacy of acupuncture as a treatment for chronic shoulder pain. We did not consider that this related to the claims made in the ad, which did not reference chronic shoulder pain.
For the reasons set out above, we considered that the claim “acupuncture for fertility support, musculoskeletal problems, headaches, migraines, insomnia, anxiety & other conditions” had not been substantiated and was misleading.
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.
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 therapies).
The ad must not appear again in its current form. We told Eileen Mannion Acupuncture they should not state or imply that acupuncture was efficacious for conditions for which they did not hold adequate evidence. We also told them to ensure where they referred to those acceptable listed conditions, they clearly state that the improvement or relief provided is short term.