Ad description
Two leaflets, for the Royal London Hospital for Integrated Medicine (RLHIM), promoted acupuncture:
a. The first leaflet was headed "Traditional Chinese Acupuncture (TCM)". Text stated "... Acupuncture is a part of Traditional Chinese Medicine (TCM), a system of healing which has been practised in China and other Eastern countries for thousands of years. Although often used as a means of pain relief, it can treat people with a wide range of illnesses. Its focus is on improving the overall well being of the patient, rather than the isolated treatment of specific symptoms ... Some of the conditions we treat include: - Women's health, including disturbances of the menstrual cycle, gynaecological disorders - Men's health, including prostatitis, urinary disorders, fertility - Emotional issues, stress, anxiety, depression, addictions - Headaches, migraines, tinnitus, dizziness, vertigo - Sleep disturbances - Immune system imbalances, allergies, Herpes zoster (Shingles) - Gastro-intestinal conditions - Musculoskeletal problems including joint pain, back pain - Upper respiratory disorders e.g. sinusitis, asthma - Hypertension (High blood pressure)".
b. The second leaflet was headed "Group Acupuncture Clinic". Text stated "... Acupuncture is a treatment which can relieve pain by stimulating the nerves in muscle and other deep body tissues. It is known that acupuncture increases the body's release of natural painkillers including endorphins and serotonin in the pain pathways of both the spinal cord and the brain ... The acupuncture at RLHIM is Western Medical acupuncture. It has been proven to be effective in the treatment of pain and muscular spasm ... Group Acupuncture Clinics are offered for: - Chronic Knee Pain (including knee osteoarthritis) - Chronic Musculoskeletal pain (including back and neck pain) - Chronic Headache and Migraine - Menopausal complaints (including hot flushes) - Facial Pain".
Issue
The Nightingale Collaboration, a health claims campaign group, challenged whether the efficacy claims for acupuncture in ads (a) and (b) were misleading and could be substantiated, and in particular whether acupuncture could treat the medical conditions listed.
Response
RLHIM submitted 43 papers as evidence to support claims of efficacy of acupuncture for chronic knee pain, chronic musculoskeletal pain including back and neck pain, chronic headache and migraine, menopausal complaints including hot flushes, overactive bladder syndrome, facial and dental pain, insomnia and medically unexplained physical symptoms. The papers included 19 published reports of acupuncture trials, 16 systematic reviews or meta-analyses of acupuncture trials, six papers relating to the cost-effectiveness of acupuncture, a guidance document from the National Collaborating Centre for Primary Care (NICE), and an article, published in the British Medical Journal (BMJ), which discussed evidence based medicine. They said the studies did not make any distinction between group acupuncture and traditional Chinese acupuncture, as referred to in the leaflets, and the evidence therefore supported the claims in both leaflets in relation to those conditions.
RLHIM agreed that some of the claims in ad (a) could not be substantiated and offered to make amendments to or to remove some of the claims. They proposed to amend the claim relating to women's health so that it would not refer to disturbances of the menstrual cycle or gynaecological disorders but instead would state "Women's health, including hot flushes and period pain". They also offered to remove all other claims in ad (a) except for references to headache and migraine, sleep disturbances, and musculoskeletal problems including joint and back pain. They proposed that they would add the claim "improved wellbeing in chronic illnesses".
Assessment
Upheld
The ASA noted that, under the subheading "Who can benefit from acupuncture?" in ad (a), text stated "Some of the conditions we treat include ..." followed by a list of conditions, and under the heading "The treatment" in ad (b), text stated "Follow up treatments may continue at longer intervals depending on how the pain responds" and "At the Royal London Hospital for Integrated Medicine, Group Acupuncture Clinics are offered for ..." followed by a list of conditions. We considered consumers would therefore understand that acupuncture could help improve or cure the conditions listed in the leaflets. Notwithstanding the specific claims in the ads which implied that acupuncture could help improve or cure the conditions listed in the ads, we also considered that, because the leaflets advertised acupuncture clinics at RLHIM, which was part of University College London Hospitals NHS Foundation Trust, consumers would understand that acupuncture could improve or cure the conditions listed in the ads whether or not there were any specific references to acupuncture helping, treating, improving or curing those conditions. We concluded that we must therefore see robust evidence to substantiate that acupuncture was efficacious in treating the conditions referenced in the ads.
We acknowledged RLHIM's offer to remove references to a number of conditions from ad (a), because they agreed they could not be substantiated by evidence, including: disturbances of the menstrual cycle, gynaecological disorders, men's health issues including prostatitis, urinary disorders and fertility, emotional issues, stress, anxiety, depression, addictions, tinnitus, dizziness, vertigo, immune system imbalances, allergies, Herpes zoster (Shingles), gastro-intestinal conditions, upper respiratory disorders such as sinusitis and asthma, and hypertension (high blood pressure). Because we had not seen evidence to substantiate the efficacy of acupuncture for those conditions, we concluded those claims were misleading. We welcomed RLHIM's willingness to remove those claims from the ad.
We noted the papers sent by RLHIM included papers relating to the cost-effectiveness of acupuncture for the treatment of persistent low back pain, chronic neck pain, osteoarthritis pain, osteoarthritis of the knee, chronic headache and headache. However, we considered that, because those papers examined the cost-effectiveness rather than the efficacy of acupuncture as a treatment for conditions, the papers were not adequate evidence on which to base claims of efficacy for acupuncture. We noted, however, that all but one of those papers appeared to be based on the findings of acupuncture trials which had also been submitted as evidence; our assessment of those trials follows below. We noted that RLHIM also provided a copy of NICE's guidance in relation to low back pain, which was a guidance document for NHS doctors. We understood that that document recommended acupuncture as a possible treatment option for patients with low back pain, but considered that it did not constitute adequate evidence on which to base claims of efficacy for acupuncture. We noted the contents of the BMJ article on evidence-based medicine, but it did not constitute evidence in support of the advertising claims. Of the remaining 35 papers, we assessed 15 and the remaining 20 were sent to an independent expert for his further assessment. Four of the papers sent by RLHIM were systematic reviews of acupuncture studies, undertaken by the Cochrane Collaboration. We understood that there were further systematic reviews of acupuncture studies by the Cochrane Collaboration which were relevant to the claims in the ads; we also sent those to the expert for assessment. Details of the assessments of the papers follow below.
RLHIM sent papers relating to studies of acupuncture as a treatment for hot flushes in menopausal women, period pain and overactive bladder syndrome in adults. However, ad (a) referred to the treatment of "Women's health, including disturbances of the menstrual cycle, gynaecological disorders" and ad (b) referred to "Menopausal complaints (including hot flushes)", and we considered that the evidence sent by RLHIM did not support such generalised claims. We concluded the claims that acupuncture was efficacious for "women's health", "disturbances of the menstrual cycle", "gynaecological disorders" and "menopausal complaints" had not been substantiated and were misleading. We assessed the evidence submitted by RLHIM in relation to hot flushes, period pain and overactive bladder syndrome in adults to determine whether it supported more specific claims for the efficacy of acupuncture in the treatment of those conditions.
RLHIM submitted a systematic review of trials of acupuncture for dysmenorrhoea (period pain), published in 2010, which included 27 trials with a total of 2960 participants. We noted the review concluded that there was promising evidence for acupuncture as a treatment for period pain, but the results were limited by methodological flaws and that large randomised controlled trials (RCTs) with rigorous methodology were needed. We concluded the evidence was not robust enough to substantiate claims of efficacy for acupuncture in the treatment of period pain.
RLHIM submitted two papers in relation to hot flushes. The first, which was an RCT published in 2009 in relation to hot flushes in menopausal women, evaluated 267 patients over a 12-week study period and reported favourable results. We sent the paper to the expert for assessment, who identified several limitations to the study, including the size of the sample, the fact that it was based in Norway and that a high proportion of participants had previously had acupuncture, all of which meant there might be limitations to the generalisability of the study results. The expert concluded there was insufficient evidence to substantiate the efficacy of acupuncture in the treatment of menopausal hot flushes. The second paper was an RCT published in 2012 in relation to hot flushes in menopausal women who were breast cancer patients. Because the paper was published after ads (a) and (b) had been published, we concluded it could not be used as evidence for the advertising claims; notwithstanding that, we also considered that because the study participants were all breast cancer patients, it was not adequate evidence on which to base future general claims about the efficacy of acupuncture for menopausal hot flushes in otherwise healthy women. We concluded we had not seen evidence which was sufficiently robust to support the claim for the efficacy of acupuncture for the treatment of menopausal hot flushes in ad (b), and concluded the claim had therefore not been substantiated and was misleading.
RLHIM submitted three papers in relation to overactive bladder syndrome in adults. We noted that all three studies used percutaneous tibial nerve stimulation (PTNS) as the active treatment, which used a fine needle electrode, inserted at the ankle, to send an electrical pulse through the tibial nerve to the sacral plexus region of the spine. We understood that descriptions of PTNS varied in the scientific literature, which sometimes specifically referenced acupuncture and sometimes did not. However, we understood that it was well-recognised that the point at which the electrode was inserted into the ankle was the SP6 acupuncture point. We understood that, although PTNS was not always identified as a form of acupuncture in medical and scientific literature, it was a variation of electro-acupuncture and we therefore considered that the RCTs which used PTNS were acceptable as evidence for electro-acupuncture at the SP6 point in the treatment of overactive bladder syndrome. The three papers on PTNS included two RCTs published in 2009 and 2010, and a long-term extension of the first phase of the 2009 RCT. We sent the papers to the expert for assessment. The expert identified some limitations to the 2009 study and its long-term extension, but concluded that the two RCTs provided preliminary evidence that PTNS might improve the symptoms of overactive bladder in the short term (i.e. up to three months). We concluded the evidence was sufficient to support advertising claims that PTNS, or electro-acupuncture at the SP6 point, could provide short-term improvement in the symptoms of overactive bladder syndrome. Nonetheless, we concluded that because the claims in ad (a), such as the reference to men's "urinary disorders", were more general, the advertising claims had not been substantiated and were misleading.
RLHIM provided copies of Cochrane reviews on acupuncture for tension-type headache and for migraine prevention, and papers for two trials for patients with headache and chronic headache, both of which were analysed as part of the Cochrane reviews. The expert had previously assessed the Cochrane reviews on behalf of CAP, and had concluded that the review of trials of acupuncture for tension-type headache demonstrated a short-term clinical benefit of acupuncture over control treatments and a small, but statistically significant, effect of acupuncture over sham interventions for most outcomes. We concluded that the evidence therefore supported claims that acupuncture could provide short-term relief of tension-type headaches only. The expert concluded that the review of trials of acupuncture for migraine prophylaxis demonstrated that acupuncture provided relief of migraine attacks, and there was some evidence that it may also be preventative. We concluded that the evidence therefore supported claims that acupuncture could provide short-term relief of migraine headache only. Whilst the evidence supported claims that acupuncture could provide short-term relief of tension-type headache and migraine headache, we noted that ad (a) referred to the treatment of "headaches [and] migraines" and ad (b) referred to "Chronic Headache and Migraine". We concluded that, because the claims in the ads referred generally to "headache" rather than specifically to tension-type headache and did not make clear that relief of both conditions was short-term, and because ad (b) referred to the treatment of "chronic" headache and migraine, the advertising claims had not been substantiated and were therefore misleading.
In support of the claim for the efficacy of acupuncture in relation to "Sleep disturbances", in ad (a), RLHIM provided a systematic review of RCTs of acupuncture treatment for insomnia, published in 2009. The review included 46 RCTs involving 3.1 3.1 Marketing communications must not materially mislead or be likely to do so. patients and concluded that acupuncture appeared to be effective in the treatment of insomnia, but that further large rigorously designed trials were warranted. We noted the review called for further trials and, furthermore, were concerned with its methodological rigour. It included five unpublished graduate dissertations, the majority of included RCTs 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 review was not sufficiently robust for its conclusions to be used to support advertising claims that acupuncture could help with insomnia or sleep disturbances, and the claim in ad (a) was therefore unsubstantiated and misleading.
We noted ad (a) referenced "Musculoskeletal problems including joint and back pain" and ad (b) referenced "Chronic musculoskeletal pain (including back and neck pain)" and "Chronic knee pain (including knee osteoarthritis)". We therefore assessed whether the evidence substantiated the claims that acupuncture could help back pain and neck pain, chronic back pain and neck pain, chronic knee pain, knee osteoarthritis pain and more generally, whether it substantiated the claims that acupuncture could help generalised musculoskeletal problems, joint pain and chronic musculoskeletal pain.
RLHIM submitted two systematic reviews, and four RCTs which post-dated the reviews, to support the claims in both ads that acupuncture could help back pain, which we passed to the expert for assessment. The expert considered that there was evidence to suggest that acupuncture had some clinical benefit in chronic low back pain in the short term. We concluded that the evidence supported limited claims that acupuncture could provide short-term relief of chronic low back pain. However, because the claims in the ads were not qualified to state that acupuncture could provide only temporary or short-term relief of chronic low back pain, we concluded they were misleading.
RLHIM sent a Cochrane review and one RCT to substantiate the claim for the efficacy of acupuncture for neck pain; we sent them to the expert for assessment. The Cochrane review, which analysed ten trials, concluded there was moderate evidence that acupuncture was more effective than some alternatives, for some types of neck pain, in the short-term, although it highlighted that there was a need for trials with adequate sample sizes which addressed the long-term efficacy of acupuncture compared to sham acupuncture. The RCT, which post-dated the Cochrane review, was a large study, which concluded that treating patients with chronic neck pain in routine primary care with acupuncture had clinically relevant benefits. The expert identified some limitations to the study, but noted that it reflected real-world medical practice which they considered increased the validity of the results. The expert concluded that there was some evidence which supported claims that acupuncture was effective in the short-term relief of neck pain or chronic neck pain. We therefore concluded that the evidence supported claims that acupuncture could provide short-term relief of neck pain or chronic neck pain. However, because the claims in the ads were not qualified to state that acupuncture could provide only short-term relief of neck pain, we concluded they were misleading.
RLHIM sent three RCTs, published in 2005 and 2006, and two systematic reviews, published in 2007, to support the claim in ad (b) that acupuncture could help "Chronic knee pain (including knee osteoarthritis)". We understood that those RCTs, and the RCTs included in the systematic reviews, only included patients with osteoarthritis of the knee, rather than those with other conditions which might cause knee pain. We therefore considered that, because the evidence appeared to relate only to pain resulting from osteoarthritis of the knee, it did not support the general claim in ad (b) that acupuncture could help "Chronic knee pain".
The two systematic reviews with regard to knee osteoarthritis included different sets of RCTs, although ten were common to both. One of the reviews included in its analysis all three RCTs sent by RLHIM, and the other review included two of the RCTs sent by RLHIM. One review concluded that acupuncture was significantly superior to sham acupuncture and to no additional intervention in improving pain and function in patients with chronic knee pain, but added that further research was required to confirm the findings and provide more information on long-term effects. The other review concluded that sham-controlled trials showed clinically irrelevant short-term benefits, although waiting-list controlled-trials suggested clinically relevant benefits, some of which might be due to placebo or expectation effects. We noted the findings of the two systematic reviews were therefore inconsistent in some areas. We understood that a more recent Cochrane review, which was published in 2010 and described itself as an update to one of the systematic reviews sent by RLHIM, also analysed many of the same RCTs on acupuncture for knee osteoarthritis, as well as including RCTs on acupuncture for hip osteoarthritis. We sent that review to the expert for assessment. The expert concluded there was some evidence that acupuncture may be an effective treatment for peripheral joint pain due to osteoarthritis, including chronic knee pain, although further studies were required. We concluded the evidence supported limited claims that acupuncture could provide temporary adjunctive treatment for osteoarthritis knee pain. However, because ad (b) did not include those limitations to the claim, we concluded the claim in the ad had not been substantiated and was misleading.
In support of the generalised claims that acupuncture could help musculoskeletal problems, joint pain and chronic musculoskeletal pain, RLHIM submitted papers relating to two RCTs of acupuncture as a treatment for shoulder pain and two papers relating to more general pain. We sent the two shoulder pain RCTs to the expert, as well as Cochrane reviews on acupuncture for shoulder pain and elbow pain, for assessment as to whether the evidence supported claims of efficacy for acupuncture for specific claims relating to shoulder and elbow pain, and more general claims relating to joint and musculoskeletal pain. With regard to shoulder pain, the expert concluded that although the two RCTs suggested acupuncture might be beneficial, the evidence from the Cochrane review conflicted with those findings, and therefore further well-designed studies were needed to confirm whether acupuncture was effective. We concluded the evidence did not, therefore, support the advertising claims that acupuncture was effective for the treatment of shoulder pain. With regard to elbow pain, the expert concluded that although the review showed there was some preliminary evidence that acupuncture might be an effective treatment, the evidence was as yet unclear and further studies were required. We concluded that the evidence was insufficient to support claims of efficacy for acupuncture as a treatment for elbow pain.
With regard to the two papers relating to more general pain, RLHIM submitted an RCT which examined the effectiveness of acupuncture in the treatment of patients with medically unexplained symptoms, who were classed as 'frequent attenders', and a meta-analysis in relation to acupuncture as a treatment for chronic pain. In the RCT, the majority of the patients suffered from musculoskeletal problems and the remainder suffered from fatigue, psychological/emotional problems or headache. The paper concluded that acupuncture had improved health status and well-being in patients, which was sustained for 12 months. However, we noted the RCT included only a small number of participants, who were not blinded to the treatment, and outcome measures were primarily self-assessed. We concluded the RCT was not sufficient to support claims of efficacy for acupuncture as a treatment for any condition. The meta-analysis, which was published in 2012, could not be used to substantiate claims which appeared in ads (a) or (b), because it was published after the ads. However, with a view to possible future advertising claims about acupuncture as a treatment for chronic pain, we sent the meta-analysis to the expert for his opinion. The meta-analysis included 31 RCTs which used acupuncture on adults with various types of chronic pain, including non-specific back or neck pain, shoulder pain, chronic headache and osteoarthritis. If pain was of musculoskeletal origin, the current episode had to have been of at least four weeks’ duration. The expert considered that the meta-analysis provided some evidence that acupuncture might be effective in the treatment of chronic non-specific musculoskeletal back or neck pain, osteoarthritis pain and chronic headache.
We concluded the findings of the meta-analysis supported the findings of the other studies RLHIM had submitted in relation to low back and chronic neck pain and therefore would contribute to the evidence base for future claims that acupuncture could provide short-term relief of chronic low back pain and short-term relief of neck pain including chronic neck pain. With regard to osteoarthritis pain, we noted that nine of the ten RCTs included in the meta-analysis related only to patients with knee osteoarthritis; the tenth related to patients with knee and/or hip osteoarthritis where around a quarter of participants were evaluated on the improvement in their hip pain. We concluded the findings of the meta-analysis therefore would contribute to the evidence base for future claims that acupuncture could provide temporary adjunctive treatment for osteoarthritis knee pain, but that it would not provide evidence for future claims that acupuncture could help in the treatment of osteoarthritis pain generally. With regard to chronic headache, the meta-analysis included six RCTs relating to migraine or headache. All but one of the RCTs had been included in the Cochrane reviews on tension-type headache or migraine referenced above and we therefore concluded that the findings of the meta-analysis would contribute to the evidence base for future claims that acupuncture could provide short-term relief of tension-type headache and of migraine headache. However, we concluded that the findings of the meta-analysis would not provide evidence for future claims that acupuncture could provide relief from "chronic headache" generally.
RLHIM provided six papers, including an RCT, four systematic reviews and a systematic review and meta-analysis, to support the advertising claim that acupuncture could help "facial pain". Two of the papers – the RCT and one systematic review – were published after ads (a) and (b) were published, and we therefore concluded they could not be used as evidence for the advertising claims. Notwithstanding that, we were concerned that the systematic review (published 2011), which analysed papers relating to seven RCTs of acupuncture in the treatment of temporomandibular (jaw joint) disorders (TMD), included RCTs which appeared to have serious methodological flaws. We also noted the review concluded that evidence for acupuncture as a symptomatic treatment of TMD was limited. The RCT (published 2012), which we sent to the expert for assessment, evaluated the effect of traditional Chinese medicine versus psychosocial self-care in the treatment of facial pain. The expert identified that there may have been recruitment bias and anyway considered that because the Chinese medicine arm of the trial included a range of treatments rather than acupuncture alone, it was not suitable as evidence to support claims relating to acupuncture alone as a treatment for facial pain. We concluded the 2011 systematic review and the 2012 RCT would not have been adequate evidence to support the claim for the efficacy of acupuncture in the treatment of "facial pain" even if they had been admissible as evidence for the advertising claim.
We sent the remaining four papers to the expert for assessment. The reviews highlighted the low methodological quality of RCTs in this area; two included such RCTs but noted that some were of low quality, and the other two (one of which also included a meta-analysis of the studies) assessed only four RCTs due to having set a high standard for inclusion in the review. Of the two reviews which included low quality RCTs, one (published in 1998) concluded that acupuncture could be considered a valid alternative to orthodox treatment for facial pain and TMD, and the other (published in 2010) concluded that it provided moderate evidence for the efficacy of acupuncture in the management of TMD. The remaining two reviews were both published in 2010 by the same authors and included the same four RCTs. The first review, which included a meta-analysis, concluded that acupuncture showed a significant short-term analgesic effect on patients with TMD of muscular origin. The second concluded that evidence was limited and only showed short-term benefits for acupuncture for TMD pain of muscular origin. The expert concluded that there was some evidence that acupuncture may be effective in the short-term for pain arising from temporomandibular disorders (TMD pain). We concluded the evidence supported limited claims that acupuncture could provide short-term relief from TMD pain. Notwithstanding that, because the claim in ad (b) was that acupuncture was efficacious in the treatment of "facial pain" generally, we concluded the claim in the ad was misleading.
Finally, we noted that in addition to offering to remove some of the claims for which they did not hold substantiation, RLHIM had proposed to include in ad (a) a statement that acupuncture could provide "improved well-being in chronic illness". We considered general claims that acupuncture could help "well-being" would not be problematic, but by linking "well-being" to "chronic illness" the statement implied that acupuncture could improve the conditions of patients with all types of chronic illnesses. We noted we had seen only limited evidence relating to a few types of chronic illness, much of which was not sufficient to support specific claims relating to those illnesses. We therefore concluded we had not seen evidence to support the proposed claim.
The ads breached CAP Code rules
3.1
3.1
Marketing communications must not materially mislead or be likely to do so.
(Misleading advertising),
3.7
3.7
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.
(Substantiation) and
12.1
12.1
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).
Action
Ads (a) and (b) must not appear again in their current form. We told RLHIM they should not state or imply that acupuncture was efficacious for conditions for which they did not hold adequate evidence.
