Background

Following the online remit extension in 2011 the ASA received a large number of complaints about claims relating to homeopathy that appeared on a number of websites. The ASA therefore made the decision to conduct an investigation to determine the acceptability of the type of claims being made for homeopathy. We understood that, as an industry body, the Society of Homeopaths had access to the relevant evidence, and we therefore considered the case was suitable to establish our lead position on claims for homeopathy.

Summary of Council decision:

Three issues were investigated, all of which were Upheld.

Ad description

a. The Society of Homeopaths’ Twitter page included the tweet "Antidepressant prescriptions up by 43%. For more holistic healthcare which doesn't rely on drugs try #homeopathy [weblink].” The web link was to the Society of Homeopaths’ home page.

b. The website for the Society of Homeopaths, www.homeopathy-soh.org, included a web page headed "What can homeopathy help?”. Text stated “Homeopaths often see patients with long-term, chronic problems, many of which have failed to respond to conventional medicine. As a system of medicine, homeopathy is aimed at treating the person, rather than the disease diagnosis, and as such can be considered in almost any ill health, where tissue has not been irrevocably damaged. Most people visit a homeopath with a diagnosis from their doctor, and patients are encouraged to keep their medical practitioners informed as treatment progresses. Some people see a homeopath because they have side effects from conventional drugs, and others because conventional tests have failed to find the cause of their problem”.

Under the subheading “Research” further text stated “There is a growing body of research evidence suggesting that treatment by a homeopath is clinically effective, cost effective and safe. People often ask about which specific conditions can be treated by homeopaths, and as a profession we would like to see more research trials addressing this question, but funding is difficult to come by. Currently, there is sufficient research evidence to support the use of homeopathic treatment for the following medical conditions: Allergies and upper respiratory tract infections, Ankle sprain, Bronchitis, Childhood diarrhoea, Chronic fatigue, Ear infections, Fibromyalgia, Hay fever, Influenza, Osteoarthritis, Premenstrual syndrome, Rheumatic diseases, Sinusitis, Vertigo ... See our research pages for more details ... Your local homeopath would be happy to discuss any health problems with you and offer advice about whether they might be able to help”.

Issue

The ASA challenged whether:

1. ad (a) could discourage essential treatment for depression, a medical condition for which medical supervision should be sought, and misleadingly implied that homeopathic remedies could alleviate symptoms of depression;

2. ad (b) could discourage essential treatment for conditions for which medical supervision should be sought; and

3. the claims in ad (b) that homeopathy could treat the following medical conditions were misleading and could be substantiated:

a. Allergies and upper respiratory tract infections;

b. Ankle sprain;

c. Bronchitis;

d. Childhood diarrhoea;

e. Chronic fatigue;

f. Ear infections;

g. Fibromyalgia;

h. Hay fever;

i. Influenza;

j. Osteoarthritis;

k. Premenstrual syndrome;

l. Rheumatic diseases;

m. Sinusitis;

n. Vertigo.

Response

1. The Society of Homeopaths did not believe the claim in ad (a) was misleading or irresponsible. They said the tweet was related to a news story that appeared in a national newspaper and reported that prescriptions of anti-depressants had increased by 43% using figures provided by the NHS Prescription Services. The sentence “Antidepressant prescriptions up by 43%” was a direct quote from the article. They believed the sentence “For more holistic healthcare which doesn't rely on drugs try #homeopathy” complied with the Code because it merely described homeopathy as a more holistic form of healthcare. They pointed out the ad made no reference to diagnosing depression and believed that it therefore did not imply this in any way. They said their members did not make medical diagnoses as this was beyond their professional remit. They agreed the ad implied that homeopaths were able to treat patients who came to them with a diagnosis of depression and that homeopathic remedies could, when prescribed by qualified homeopaths, treat depression. They said they implied this deliberately as they believed the claim was capable of substantiation. They said that a study (which they provided) had shown that individualised homeopathic prescribing had been shown to be non-inferior to the most commonly prescribed anti-depressant medicine.

2. The Society of Homeopaths did not believe there was anything on the web page in question, or their website as a whole, which discouraged patients from seeking medical treatment. They said they were committed to promoting integrated healthcare, and that this was made clear on their home page, which stated “Homeopathy can be used alongside conventional medicine when necessary to give an integrated approach to your healthcare”. They also referred to another web page headed “What happens when I see a homeopath” which stated that they recommended maintaining your relationship with your GP or specialist and that although homeopathy could reduce or remove the need for conventional drugs, you should continue with any treatment already prescribed and only change this after discussion with your prescribing doctor and homeopath. It also stated “If at any stage of your treatment you are concerned about changes in your symptoms, you should contact your homeopath and/or medical practitioner immediately”.

3. The Society of Homeopaths said that since the ad was initially seen, the wording “Currently, there is sufficient research evidence to support the use of homeopathic treatment for the following medical conditions” had been amended to “To date, conditions for which the majority of clinical trial findings have been positive include …”. They therefore believed it would only be relevant to substantiate the newly worded claim. They supplied 21 studies to support the claims in relation to the listed conditions. They did not believe the ad implied that the evidence was unequivocal or was the accepted view of the entire medical or scientific community.

Assessment

1. Upheld

The CAP Code stated that marketers must not discourage essential medical treatment for conditions for which medical supervision should be sought, and this included offering specific advice on the treatment for such conditions unless that advice or treatment was conducted under the supervision of a suitably qualified health professional. The ASA considered that depression was a condition for which medical supervision should be sought.

We considered that the reference to antidepressant prescriptions and the invitation to “try” homeopathy meant the ad was targeted at consumers with a pre-existing diagnosis of depression, particularly those who had been prescribed antidepressants. We considered the average consumer targeted by the ad was therefore particularly vulnerable. We considered that the ad encouraged these consumers to visit the Society of Homeopath’s home page and consider consulting a homeopath with a view to obtaining advice on or treatment for their depression.

We noted that 'homeopath' was not a protected title in the UK and that homeopathy was not subject to statutory regulation. Because the ad referred to homeopathy in general, rather than treatment by a specific individual, we did not consider the advertiser could demonstrate that all such treatment would be conducted under the supervision of a suitably qualified health professional.

Because the Code prohibited referring to depression, a serious medical condition in this way, regardless of whether the claim could be substantiated, we did not go on to assess evidence for the treatment of depression with homeopathy.

We concluded that, because the ad marketed treatment for depression, a serious condition for which medical supervision should be sought, the ad breached the Code.

On this point ad (a) breached CAP Code (Edition 12) rule  12.2 12.2 Marketers must not discourage essential treatment for conditions for which medical supervision should be sought. For example, they must not offer specific advice on, diagnosis of or treatment for such conditions unless that advice, diagnosis or treatment is conducted under the supervision of a suitably qualified health professional. Accurate and responsible general information about such conditions may, however, be offered (see rule  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.
 ).
Health professionals will be deemed suitably qualified only if they can provide suitable credentials, for example, evidence of: relevant professional expertise or qualifications; systems for regular review of members' skills and competencies and suitable professional indemnity insurance covering all services provided; accreditation by a professional or regulatory body that has systems for dealing with complaints and taking disciplinary action and has registration based on minimum standards for training and qualifications.
 (Medicines, medical devices, health related products and beauty products).

2. & 3.c, j & n Upheld

The CAP Code stated marketers must not discourage essential medical treatment for conditions for which medical supervision should be sought. The ad listed a number of medical conditions and stated there was sufficient research evidence to support the use of homeopathic treatment for those conditions. We considered that bronchitis, osteoarthritis and vertigo, a subtype of dizziness, were conditions for which medical supervision should be sought.

We considered that the reference to these specific medical conditions meant the ad was targeted at consumers with a pre-existing diagnosis of these conditions or who were suffering from those symptoms. We considered the average consumer targeted by the ad was therefore particularly vulnerable. We considered that the ad encouraged these consumers to consider consulting a homeopath with a view to obtaining advice on or treatment for their conditions.

The ad stated that patients were encouraged to keep their medical practitioners informed. However, the CAP Code stated that marketers must not offer treatment for conditions for which medical supervision should be sought, unless that treatment was conducted under the supervision of a suitably qualified health professional. We noted that 'homeopath' was not a protected title in the UK and that homeopathy was not subject to statutory regulation. Because the ad referred to homeopathy in general, rather than treatment by a specific individual, we did not consider the advertiser could demonstrate that all such treatment would be conducted under the supervision of a suitably qualified health professional.

Because the Code prohibited referring to bronchitis, osteoarthritis and vertigo in this way, regardless of whether the claims could be substantiated, we did not go on to assess evidence for the treatment of these conditions with homeopathy.

We concluded that, because the web page marketed treatment for bronchitis, osteoarthritis and vertigo, conditions for which medical supervision should be sought, the ad breached the Code.

On these points ad (b) breached CAP Code (Edition 12) rule  12.2 12.2 Marketers must not discourage essential treatment for conditions for which medical supervision should be sought. For example, they must not offer specific advice on, diagnosis of or treatment for such conditions unless that advice, diagnosis or treatment is conducted under the supervision of a suitably qualified health professional. Accurate and responsible general information about such conditions may, however, be offered (see rule  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.
 ).
Health professionals will be deemed suitably qualified only if they can provide suitable credentials, for example, evidence of: relevant professional expertise or qualifications; systems for regular review of members' skills and competencies and suitable professional indemnity insurance covering all services provided; accreditation by a professional or regulatory body that has systems for dealing with complaints and taking disciplinary action and has registration based on minimum standards for training and qualifications.
 (Medicines, medical devices, health related products and beauty products).

3. We considered that the reference to specific medical conditions meant the ad was targeted at consumers with a pre-existing diagnosis of these conditions, or, in the case of more common conditions such as upper respiratory tract infections (commons colds) or ear infections, consumers who anticipated the possibility of suffering from these at some point in the future. We considered the average consumer targeted by the ad could therefore be particularly vulnerable. We considered that consumers would interpret the claims in the ad to mean that robust scientific evidence supported the use of homeopathy to treat the listed conditions and that the ad encouraged these consumers to consider consulting a homeopath with a view to obtaining advice on or treatment for their conditions.

We acknowledged that some individuals who preferred their holistic approach may report benefits to their wellbeing from a therapy session with a homeopath. However, the CAP Code required health claims to be backed by evidence, which would be assessed on the basis of the available scientific knowledge. The most robust form of evidence when referring to conditions in this way was that relating to efficacy and evidence of self-reported benefits was therefore not sufficient.

We acknowledged that since receiving the complaint the wording of the ad had been amended slightly. In our assessment we considered the ad as it appeared at the time the complaint was raised. However, we did not consider that the new wording would have changed the way in which consumers interpreted the claims. We considered that listing medical conditions in this way meant consumers would expect the advertisers to hold robust scientific evidence to support the use of homeopathy for the listed conditions.

The CAP Code stated that objective medical claims must be backed by evidence, and that substantiation would be assessed on the basis of the available scientific knowledge. The evidence we considered in assessing the claims consisted of the House of Commons’ Science and Technology Committee’s Evidence Check 2 report on homeopathy (EC2), the evidence provided by the Society of Homeopaths and the Swiss publication ‘Homeopathy in Healthcare’. Some of the evidence supplied by the Society of Homoeopaths was not in English, although all contained English summaries. ASA Procedures stated that all evidence must be provided in English. The Society of Homeopaths were notified of this but did not supply us with translations for all documents and so we only considered the English summaries. We took expert advice on the evidence.

The House of Commons’ Science and Technology Committee had carried out an investigation in 2009–10 into the British Government’s policies on the provision of homeopathy through the National Health Service (NHS) and the licensing of homeopathic products by the Medicines and Healthcare products Regulatory Authority (MHRA). Although their enquiry was not into homeopathy itself, the Committee did look at the issue of efficacy as part of their investigation and heard from a number of expert witnesses as well as considering the evidence as a whole, including representations by homeopathic practitioners. The Committee agreed that the gold standard of efficacy, as in conventional clinical medicine, was randomised, double-blinded, controlled trials, but that meta analyses of several trials or comprehensive systematic reviews were the most important in establishing evidence of efficacy. It also distinguished between efficacy (whether the product is shown to have an effect in controlled conditions) and effectiveness (whether the product helps patients in real-life conditions, with a range of outcomes such as patient preference and impact on other medical conditions or medication considered). The Committee concluded that homeopathic products were not efficacious because they produced effects no better than those of a placebo treatment. They went on to state that they did not believe further research into homeopathy was warranted because sufficient testing had already taken place and evidence showed that it was not efficacious. Our expert considered that EC2 was a robust and fair examination of the evidence for the efficacy of homeopathy available to it and that it came to appropriate conclusions. The Swiss publication ‘Homeopathy in Healthcare’ was published following the Complementary Medicine Evaluation Programme (PEK) set up by the government of Switzerland following an earlier decision to provisionally include various complementary health disciplines, including homeopathy, in the services covered by the national health insurance scheme. The primary purpose of the PEK was to decide whether complementary medicine practices should be under this scheme - balancing the high public demand and widespread use of them with concerns from mainstream medicine regarding efficacy and potential harm. The publication's main conclusion regarding efficacy was drawn from a reconsideration of a previous meta-analysis of qualifying trials which found no significant difference between placebo and homeopathic treatment and had been published in a reputable peer reviewed journal. It featured a reworking of the analysis of the data by considering only therapeutic studies, and removing the prevention studies.

This led to the number of significant trials versus non-significant becoming 28 vs 23, as opposed to 32 vs 33 in the original publication. The report’s authors described this as “a truly remarkable result in favour of homeopathy” but also stated more cautiously that the analysis “does not prove the ineffectiveness of homeopathy”. Our expert agreed with this second statement only. Our expert pointed out that the report looked at issues beyond efficacy, such as real world effectiveness, safety and economy, which was an approach wider than that taken by conventional medical reviews, which would only examine efficacy. However, the problem with studies looking at measures beyond efficacy was that positive effectiveness outcomes for homeopathy could be the result of the placebo effect alone. He also pointed out that the report was context specific, and that the Swiss context was different from that in the UK.

Our expert commented on the difficulties in assessing evidence for homeopathy in general. He said that trials were often confounded by a generally accepted placebo effect and the design of such trials was often inadequate, particularly with regard to patient numbers, making statistical significance difficult to establish. His overall opinion of the evidence presented by the Society of Homeopaths, and the general body of published scientific and clinical data, was that it was not convincing in terms of efficacy and it was unlikely to be generally accepted by the scientific community.

3a. Upheld

The Society of Homeopaths provided three studies to substantiate the claim that there was sufficient research evidence to support the use of homeopathic treatment for allergies and upper respiratory tract infections. Our expert advised us that the first paper concentrated on effectiveness, safety and cost effectiveness rather than efficacy. The second paper concerned 24 studies, but those with the highest patient numbers showed only non-significant effects in favour of homeopathy or no effectiveness over placebo. The third paper concerned 27 trials and studies and some evidence suggested in some conditions, homeopathy showed some benefit. However, the authors noted that there were general weaknesses in the evidence due to the lack of independent confirmation of reported trials and the presence of conflicting results. Our expert considered that the evidence was not sufficient to support efficacy claims for homeopathy for the treatment of allergies and upper respiratory tract infections. We therefore concluded the claim was misleading and had not been substantiated.

On this point ad (b) breached CAP Code (Edition 12) 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 products).

3b. Upheld

The Society of Homeopaths provided one study to substantiate the claim that there was sufficient research evidence to support the use of homeopathic treatment for ankle sprain. However, the study was in German and so our expert only considered the short English summary. This stated that in a study of 73 patients, improvements in joint mobility were noted in the active group. However, because we were not able to examine the data in full we consider the evidence was not sufficient to support efficacy claims for homeopathy for the treatment of ankle sprains. We therefore concluded the claim was misleading and had not been substantiated.

On this point ad (b) breached CAP Code (Edition 12) 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 products).

3d. Upheld

The Society of Homeopaths provided one study to substantiate the claim that there was sufficient research evidence to support the use of homeopathic treatment for childhood diarrhoea. A meta analysis had been conducted on three double-blind trials on a total of 242 children. Children received either an individualised homeopathic medicine or a placebo. The authors concluded that individualised homeopathic treatment decreased the duration of acute childhood diarrhoea. However, our expert considered that the use of individualised homeopathic treatments was problematic because it meant the materials in the ‘active’ arm of the studies were not identical. He considered this meant the studies were assessing effectiveness rather than efficacy and therefore the evidence was not sufficient to support efficacy claims for homeopathy for the treatment of childhood diarrhoea. We therefore concluded the claim was misleading and had not been substantiated.

On this point ad (b) breached CAP Code (Edition 12) 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 products).

3e. Upheld

The Society of Homeopaths provided one study to substantiate the claim that there was sufficient research evidence to support the use of homeopathic treatment for chronic fatigue. This consisted of a systematic review of 25 eligible randomised controlled trials that examined homeopathy treatments in psychiatry, including the treatment of chronic fatigue syndrome. The authors stated there was some evidence for the efficacy of homeopathy in chronic fatigue syndrome. The authors concluded that the results did not preclude the possibility of some benefit of homeopathic treatment in psychiatry, and our expert agreed with this conclusion. However, he considered that the study was examining effectiveness rather than efficacy, as the ‘active’ test materials were not identical, he did not consider the evidence was sufficient to support efficacy claims for homeopathy for the treatment of chronic fatigue. We therefore concluded the claim was misleading and had not been substantiated.

On this point ad (b) breached CAP Code (Edition 12) 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 products).

3f. Upheld

The Society of Homeopaths provided one study to substantiate the claim that there was sufficient research evidence to support the use of homeopathic treatment for ear infections. The paper concerned 24 studies, but those with the highest patient numbers showed only non-significant effects in favour of homeopathy or no effectiveness over placebo. Our expert considered that the evidence was not sufficient to support efficacy claims for homeopathy for the treatment of ear infections. We therefore concluded the claim was misleading and had not been substantiated.

On this point ad (b) breached CAP Code (Edition 12) 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 products).

3g. Upheld

The Society of Homeopaths provided two studies to substantiate the claim that there was sufficient research evidence to support the use of homeopathic treatment for fibromyalgia. One was a systematic review of 25 eligible randomised controlled trials (also provided in relation to chronic fatigue) that examined homeopathy treatments in psychiatry, including the treatment of fibromyalgia. The authors stated there was some evidence for the efficacy of homeopathy in fibromyalgia, but that the studies were neither sufficiently rigorous nor sufficiently plentiful to provide a definitive answer. They concluded that the results did not preclude the possibility of some benefit of homeopathic treatment in psychiatry, and our expert agreed with this conclusion. However, he considered that the study was examining effectiveness rather than efficacy, as the ‘active’ test materials were not identical, he did not consider it was sufficient to support efficacy claims. The second study consisted of a systematic review of randomised clinical trials of homeopathy as a treatment for fibromyalgia. Four trials were eligible. However, our expert noted that none were without serious flaws and that independent replications were missing. He therefore considered they were insufficient to support efficacy claims for homeopathy for the treatment of fibromyalgia. We therefore concluded the claim was misleading and had not been substantiated.

On this point ad (b) breached CAP Code (Edition 12) 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 products).

3h. Upheld

The Society of Homeopaths provided three studies to substantiate the claim that there was sufficient research evidence to support the use of homeopathic treatment for hay fever. The first study was a meta analysis of 11 placebo-controlled trials, 7 of which were randomised and double-blind, with a total of 752 patients. The authors concluded that homeopathic treatment showed superior efficacy over placebo, but shortcomings were that the active product varied in dilution and that results in studies relating to hay fever suffered from a high placebo response. Our expert considered that the studies could at best be considered as concerned with effectiveness and were not sufficient to establish efficacy. The second study was a randomised controlled trial of homeopathy versus placebo, and aimed to test the hypothesis that homeopathy was a placebo by testing its effect on patients with hay fever. The authors concluded the results reinforced earlier evidence that homeopathic dilutions differed from placebo, but that paradoxically the improvements in quantitative measurements were not paralleled by improvements in subjective assessments, which also reported patients with more aggravations. Our expert said he agreed with their objective findings, but did draw attention to the small sample size (51) and the puzzling discrepancy between the objective and subjective results. The third paper (also provided in relation to allergies and upper respiratory tract infections) concerned 27 trials and studies and some evidence suggested that in some conditions homeopathy showed some benefit. However, the authors noted that there were general weaknesses in the evidence due to the lack of independent confirmation of reported trials and the presence of conflicting results. Our expert considered that the study was not sufficient to support efficacy claims. We therefore concluded the claim was misleading and had not been substantiated.

On this point ad (b) breached CAP Code (Edition 12) 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 products).

3i. Upheld

The Society of Homeopaths provided one study to substantiate the claim that there was sufficient research evidence to support the use of homeopathic treatment for influenza. The paper consisted of a review of seven studies into the use of homeopathic remedy Oscillococcinum for preventing and treating influenza. There was no evidence that treatment could prevent influenza-like syndrome, but there was evidence that Oscillococcinum reduced the length of influenza by 0.28 days and increased the chance of a patient considering treatment effective. The authors concluded the data was not strong enough to support a general recommendation for use of Oscillococcinum and that further research was required with large sample sizes. Our expert considered that the evidence was not sufficient to support efficacy claims for homeopathy for the treatment of influenza. We therefore concluded the claim was misleading and had not been substantiated.

On this point ad (b) breached CAP Code (Edition 12) 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 products).

3k. Upheld

The Society of Homeopaths provided one study to substantiate the claim that there was sufficient research evidence to support the use of homeopathic treatment for premenstrual syndrome. The study aimed to test the efficacy of homeopathic treatment in relieving symptoms associated with premenstrual syndrome on 20 women and was scored via a daily menstrual distress questionnaire. Improvement was seen in more patients being treated with the active product and the improvement was greater. However, our expert considered that, because the study size was so small and the homeopathic products varied but were not distinguished in the analysis, the study was a pilot on effectiveness but was not sufficient to support efficacy claims. We therefore concluded the claim was misleading and had not been substantiated.

On this point ad (b) breached CAP Code (Edition 12) 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 products).

3l. Upheld

The Society of Homeopaths provided one study to substantiate the claim that there was sufficient research evidence to support the use of homeopathic treatment for rheumatic diseases. The authors stated that results were mixed as to efficacy, but that it appeared that homeopathic remedies worked better than a placebo in studies of rheumatic syndromes, but there were too few studies to make definitive conclusions about the efficacy of any one type of homeopathic treatment on any one condition. Our expert considered that the evidence was not sufficient to support efficacy claims for homeopathy for the treatment of rheumatic diseases. We therefore concluded the claim was misleading and had not been substantiated.

On this point ad (b) breached CAP Code (Edition 12) 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 products).

3m. Upheld

The Society of Homeopaths provided four studies to substantiate the claim that there was sufficient research evidence to support the use of homeopathic treatment for sinusitis. The first study was a randomised double-blind trial which compared treatment with a homeopathic remedy and a placebo in 144 patients with acute rhinosinusitis. The authors concluded homeopathy was an effective and tolerable treatment for the condition. The placebo product was not described. Our expert said that the homeopathic product tested was a commercial product which contained concentrations of materials which were at the upper limits for what was generally considered to be ‘homeopathic’. He also said that two of the materials in the remedy were single chemical entities, as opposed to the more commonly used plant extracts. He therefore considered that, notwithstanding the claimed demonstrated efficacy of this particular product, it would not be justified to extrapolate the result to draw general conclusions about the efficacy of homeopathic remedies on sinusitis in general. The second study examined the efficacy of a specific homeopathic remedy (Sinfrontal) in 113 patients with acute maxillary sinusitis in a randomised double-blind controlled trial. The results showed a significant reduction in ‘sinusitis severity score’ compared to placebo and an earlier remission of symptoms. Our expert considered that the evidence supported the superiority of the remedy over placebo. However, he pointed out that the homeopathic remedy used was at the most concentrated for homeopathic preparations and it was conceivable that patients would therefore have received a dose of the original homeopathic substance. He therefore considered that the product tested was not representative of homeopathic preparations generally and it would not be appropriate to draw wider conclusions regarding homeopathy in general. The third study was in German and we considered the English summary only. The study compared two specific homeopathic remedies to a placebo in the treatment of chronically recurrent rhinosinusitis. The authors stated that one of the homeopathic products was significantly superior to placebo, most evidently within the subjective criteria. However, our expert noted a higher number of patients rated the placebo as ‘very good’ than for the homeopathic product. The second product showed no difference in results to the placebo. Our expert considered the results were modest and somewhat confusing and were not sufficient to demonstrate efficacy. The fourth study was in German and we considered the English summary only. A randomised double-blind controlled study compared the efficacy of three homeopathic preparations with a placebo in the treatment of sinusitis in 152 patients. There was no significant difference in the therapeutic success of any of the treatments over placebo. Our expert did not consider that overall the evidence was sufficient to support efficacy claims for homeopathy for the treatment of sinusitis. We therefore concluded the claim was misleading and had not been substantiated.

On this point ad (b) breached CAP Code (Edition 12) 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 products).

Action

Ads (a) and (b) must not appear again in their current form. We told the Society of Homeopaths not to discourage essential treatment for conditions for which medical supervision should be sought, including offering specific advice on or treatment for such conditions. We also told them not to make health claims for homeopathy unless they held sufficiently robust evidence of efficacy.

CAP Code (Edition 12)

12.1     12.2     3.1     3.7    


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