Background
Summary of Council decision:
Eleven issues were investigated, of which ten were Upheld and one was Not upheld.
We have not investigated this leaflet under CAP Code rule 12.2 (Medicines, medical devices, health-related products and beauty products) as we understand that treatment at The Royal Hospital for Integrated Medicine would be conducted under the supervision of a suitably qualified health professional; a consultant physician registered with the GMC. Furthermore, patients were referred to the hospital by their GP or their NHS consultant.
Ad description
A leaflet for a University College London Hospitals clinic was entitled "Western Herbal Medicine". Text inside the leaflet, under the heading "Western Herbal Medicine", stated, "Herbal medicine is the use of plant-based medicines to promote good health and treat illness. It combines traditional knowledge with insights from clinical and laboratory research into the active constituents of herbs". Further text stated, "Conditions particularly suitable for treatment by herbal medicine are: digestive disorders, urinary disorders, allergies, women's health, joint problems, stress, skin conditions, hormonal conditions, fatigue syndromes, recurrent infections, migraine".
Issue
The Nightingale Collaboration challenged whether the advertiser could substantiate the claims that herbal medicine was particularly suitable for the treatment of:
1. digestive disorders;
2. urinary disorders;
3. allergies;
4. women's health;
5. joint problems;
6. stress;
7. skin conditions;
8. hormonal conditions;
9. fatigue syndromes;
10. recurrent infections; and
11. migraine.
Response
University College London Hospitals (UCLH) submitted evidence in the form of numerous clinical trials, systematic reviews and meta-analyses. They said that this body of evidence supported the claims that herbal medicine could be used to treat the listed conditions.
1. UCLH submitted evidence covering inflammatory bowel disease, dyspepsia and irritable bowel syndrome. Five papers were submitted to support the use of various herbal medicines in inflammatory bowel disease. Three were randomised controlled trials (RCTs): (1) evaluated Boswellia serrata for collagenous colitis; (2) evaluated wheat grass juice for active distal ulcerative colitis; and (3) evaluated aloe vera gel for active ulcerative colitis. The fourth paper was an open-label, non-randomised trial that evaluated Boswellia serrata in patients with chronic colitis, and the fifth was a randomised, open-label, uncontrolled study that evaluated Artemisia absinthum for Crohn's disease.
Five papers were submitted to support the use of various herbal medicines for the relief of symptoms of either irritable bowel syndrome or functional dyspepsia: three randomised controlled trials that evaluated red pepper powder, a fixed combination of peppermint oil and caraway oil, and artichoke leaf extract; and one meta-analysis that evaluated STW5 (Iberogast) for functional dyspepsia. One meta-analysis was submitted to evaluate the effect of fibre, antispasmodics and peppermint oil in the treatment of irritable bowel syndrome.
2. UCLH submitted four reports in support of using Western herbal medicines in the treatment of urinary disorders. Three were trials assessing the use of a particular presentation of a combined Sabal and Urtica extract (Prostagutt forte™, also known as PRO 160/120) in the treatment of lower urinary tract symptoms in elderly men with benign prostatic hyperplasia (BPH) and one was a systematic review assessing the evidence to support the use of cranberry-based products for the prevention of urinary tract infections (UTIs).
3. UCLH submitted four reports to support the use of Western herbal medicine for "allergies". This included three RCTs and one systematic review. The RCTs included two that looked at butterbur and one that considered a particular complex herbal remedy, for the treatment of allergic rhinitis. The systematic review incorporated the results of six controlled trials of BNO-101 in patients with sinusitis.
4. & 8. UCLH responded to these points together by submitting 11 studies to support the claims that Western herbal medicine was suitable for the treatment of "women's health" and "hormonal conditions". Three studies investigated using vitex agnus castus for the treatment of premenstrual syndrome. Another study looked at the same remedy for treating cyclical mastalgia. Four studies investigated herbal medicines for the treatment of menopausal symptoms. One report submitted was a general treatment review looking at complementary and alternative remedies for menopausal symptoms. Finally, two Cochrane reviews were submitted; one that assessed the evidence for Chinese herbal medicine for primary dysmenorrhoea and one that assessed the evidence for Chinese herbal medicine in endometriosis.
5. UCLH submitted 19 reports to support the claim that Western herbal medicine was suitable for use in the treatment of joint disorders: two systematic reviews; one meta-analysis; an open label randomised post marketing study; and 15 RCTs. The use of willow bark was investigated in three RCTs (one for osteoarthritis (OA) and two for back pain) and in a systematic review of musculoskeletal disorders. The use of rose hip for OA was addressed in three RCTs and one meta-analysis. Four RCTs looked at comfrey root: two for OA and two for back pain. Two RCTs looked at Harpagophytum procumbens for low back pain. A systematic review investigated the use of Harpagophytum procumbens for OA and back pain. Studies (one study for each) looking at treating knee OA using Boswellia serrata extract, cat's claw extract, Curcuma domestica extract or 5-Loxin; and for rheumatoid arthritis (RA) using Uncaria tomentosa extract and Tripterygium wilfordii Hook f were submitted.
6. UCLH provided five reports to support the claim that Western herbal medicine was suitable for the treatment of stress. This included one systematic review that assessed the evidence for St John's wort in the treatment of major depression; another systematic review that assessed the evidence for kava kava for treating anxiety; two RCTs assessing the efficacy of Rhodiola rosea L extract (SHR-5) ‒ one for mild-to-moderate depression and one for stress-related fatigue; finally, one RCT which assessed the efficacy of chamomile extract in the treatment of generalised anxiety disorder.
7. UCLH provided five reports in support of the claim that Western herbal medicine was suitable for the treatment of "skin conditions". These reports covered two conditions: psoriasis and atopic dermatitis. For treating psoriasis two studies assessed the efficacy and safety of Mahonia aquifolium and one study assessed Indigo naturalis. For treating atopic dermatitis, one study assessed licorice gel and one using St John's Wort cream.
9. UCLH submitted two RCTs in support of the claim that Western herbal medicine was suitable for the treatment of "fatigue syndromes". One looked at using SHR-5, a standardised extract of Rhodiola rosea, in the treatment of stress-related fatigue. The other RCT looked at using Siberian ginseng for chronic fatigue.
10. UCLH provided five reports for Western herbal medicine and the treatment of recurrent infections. Two were systematic reviews that assessed the evidence for using Pelargonium sidiodes extract ‒ one for treating acute bronchitis and one for treating acute respiratory tract infections. A further systematic review looked at the evidence for using Echinacea in treating and preventing the common cold. A fourth systematic review looked at the evidence for Andrographis paniculata for the treatment of upper respiratory tract infections. Finally, a RCT was submitted that looked at the efficacy of an oral elderberry extract in the treatment of influenza A and B virus infections.
11. UCLH provided four studies for Western herbal medicine and migraine. Two were trials comparing butterbur root extract with placebo; one was a re-analysis of a previous study. One study compared a phytoestrogen preparation with placebo for the prophylaxis of menstrual migraine. One study looked at using a feverfew extract for migraines.
Assessment
The evidence submitted by UCLH was sent to an independent expert for further assessment.
1. Upheld
The ASA noted the five papers submitted in support of herbal medicine's ability to treat inflammatory bowel disease. The studies incorporated only a small number of patients and were of a short duration; furthermore, none included power calculations to demonstrate conclusively whether the treatments were efficacious. For these reasons, we did not consider the evidence in support of herbal medicine for inflammatory bowel disease to be sufficiently robust.
The studies submitted in relation to irritable bowel syndrome and functional dyspepsia provided robust evidence, in the form of three RCTs, supporting the use of red pepper powder, a fixed combination of peppermint oil and caraway oil, and artichoke leaf extract for the treatment of functional dyspepsia. The meta-analysis for STW5 and the meta-analysis looking at fibre, antispasmodics and peppermint oil, also supported the use of those treatments for symptoms of irritable bowel syndrome.
We considered that the evidence submitted supported the use of some Western herbal remedies for the treatment of functional dyspepsia and for symptoms associated with irritable bowel syndrome. However, the ad claimed that Western herbal was suitable for the treatment of "Digestive Disorders". We considered that to support this more general claim, UCLH should have provided evidence covering a broader range of conditions. For example, we noted that no evidence was submitted in support of Western herbal medicines being able to treat gastro-oesophageal reflux disease (GORD), which we understood was a common digestive disorder.
Although we had seen evidence that would have been suitable to support more specific claims about Western herbal medicine for functional dyspepsia and symptoms associated with irritable bowel syndrome, because we had not seen enough robust clinical evidence, covering a range of conditions that could be inferred by the claim "digestive disorders", we concluded that that claim was unsubstantiated and misleading.
On this point the ad breached CAP Code (Edition 12) rules
3.1
3.1
Marketing communications must not materially mislead or be likely to do so.
and
3.3
3.3
Marketing communications must not mislead the consumer by omitting material information. They must not mislead by hiding material information or presenting it in an unclear, unintelligible, ambiguous or untimely manner.
Material information is information that the consumer needs to make informed decisions in relation to a product. Whether the omission or presentation of material information is likely to mislead the consumer depends on the context, the medium and, if the medium of the marketing communication is constrained by time or space, the measures that the marketer takes to make that information available to the consumer by other means.
(Misleading advertising) and
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).
2. Upheld
We considered the three reports that looked at lower urinary tract symptoms in men with BPH all had flaws in their methodology and could not be considered suitably robust evidence. The Cochrane systematic review on the use of cranberry-based products, although robust, only provided positive results in relation to a reduction in risk in women with recurrent UTIs.
We considered that "Urinary disorders" was a general term that would be understood to cover a range of conditions and symptoms. No evidence was provided to support the herbal medicines for other common "urinary disorders", such as urinary incontinence.
We therefore concluded that the general claim that appeared in the ad was not substantiated and was therefore misleading.
On this point the ad breached CAP Code (Edition 12) rules
3.1
3.1
Marketing communications must not materially mislead or be likely to do so.
and
3.3
3.3
Marketing communications must not mislead the consumer by omitting material information. They must not mislead by hiding material information or presenting it in an unclear, unintelligible, ambiguous or untimely manner.
Material information is information that the consumer needs to make informed decisions in relation to a product. Whether the omission or presentation of material information is likely to mislead the consumer depends on the context, the medium and, if the medium of the marketing communication is constrained by time or space, the measures that the marketer takes to make that information available to the consumer by other means.
(Misleading advertising) and
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).
3. Upheld
We considered that one butterbur RCT was more robust than the other, but that the test material was not precisely defined, which significantly limited its quality. The other RCT also lacked precise product definition. The systematic review was also lacking in detail and robustness.
Furthermore, the ad referred to "allergies" and we considered that consumers would therefore infer from the claim that Western herbal treatment could be used to treat a wider range of conditions than was represented by the evidence submitted by UCLH.
Because the conditions covered by the evidence was not suitably broad to support the general claim that Western herbal medicine was suitable for the treatment of "allergies", and because the evidence we had seen was not suitably robust, we concluded that the ad was misleading on this point.
On this point the ad breached CAP Code (Edition 12) rules
3.1
3.1
Marketing communications must not materially mislead or be likely to do so.
and
3.3
3.3
Marketing communications must not mislead the consumer by omitting material information. They must not mislead by hiding material information or presenting it in an unclear, unintelligible, ambiguous or untimely manner.
Material information is information that the consumer needs to make informed decisions in relation to a product. Whether the omission or presentation of material information is likely to mislead the consumer depends on the context, the medium and, if the medium of the marketing communication is constrained by time or space, the measures that the marketer takes to make that information available to the consumer by other means.
(Misleading advertising) and
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).
4. & 8. Upheld
We did not consider the general treatment review to be useful in supporting the claims in the ad because, unlike an RCT or a systematic review, it did not analyse any data. The Cochrane review for Chinese herbal medicine for primary dysmenorrhoea was of good quality, but included some studies of poor methodological quality. Although the range of conditions covered by the studies and reviews was sufficiently broad to theoretically support the general claims "women's health" and "hormonal issues", we considered that overall the evidence was not sufficiently robust. For these reasons, despite the evidence being suitable to support a more specific claim about Western herbal medicine for the treatment of premenstrual syndrome, we concluded that the ad was misleading on this point.
On this point the ad breached CAP Code (Edition 12) rules
3.1
3.1
Marketing communications must not materially mislead or be likely to do so.
and
3.3
3.3
Marketing communications must not mislead the consumer by omitting material information. They must not mislead by hiding material information or presenting it in an unclear, unintelligible, ambiguous or untimely manner.
Material information is information that the consumer needs to make informed decisions in relation to a product. Whether the omission or presentation of material information is likely to mislead the consumer depends on the context, the medium and, if the medium of the marketing communication is constrained by time or space, the measures that the marketer takes to make that information available to the consumer by other means.
(Misleading advertising) and
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).
5. Upheld
We noted that the reports submitted covered three joint disorders: osteoarthritis (OA), rheumatoid arthritis and lower back pain. Overall, half of the studies submitted lacked sufficient details on design, methodology and/or statistical analysis to be considered suitably robust. Other weaknesses that limited the usefulness of the studies in supporting the general claim that Western herbal medicine was suitable for the treatment of joint problems included small sample sizes, short durations and populations that might not have been representative of the typical patient population.
There was reasonably robust evidence to support the use of willow bark for back pain and rose hip for OA. The evidence for the remaining herbal medicines was weak. Although we saw robust evidence in support of some specific claims, because we did not see enough robust evidence for the more general claim on "joint problems" we concluded that that claim was unsubstantiated and misleading.
On this point the ad breached under CAP Code (Edition 12) rules
3.1
3.1
Marketing communications must not materially mislead or be likely to do so.
and
3.3
3.3
Marketing communications must not mislead the consumer by omitting material information. They must not mislead by hiding material information or presenting it in an unclear, unintelligible, ambiguous or untimely manner.
Material information is information that the consumer needs to make informed decisions in relation to a product. Whether the omission or presentation of material information is likely to mislead the consumer depends on the context, the medium and, if the medium of the marketing communication is constrained by time or space, the measures that the marketer takes to make that information available to the consumer by other means.
(Misleading advertising) and
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).
6. Upheld
We considered that the systematic review provided good evidence in support of St John's wort for the treatment of depression. The other systematic review also provided some good evidence for the effectiveness of kava kava in treating anxiety. However, we understood that in 2003 the Medicines and Healthcare Products Regulatory Agency (MHRA) prohibited the use of kava kava as a medicine because of concerns of hepatotoxicity. We were therefore concerned about the suitability of this review as evidence for the claim that Western herbal medicine could be used to treat stress. We considered that the RCTs contained too many methodological weaknesses to be accepted as suitably robust.
For these reasons, although there was good evidence for the treatment of depression, because we had not seen sufficient evidence for the use of Western herbal medicine in the treatment of "stress", we concluded that the ad was misleading.
On this point the ad breached CAP Code (Edition 12) rules
3.1
3.1
Marketing communications must not materially mislead or be likely to do so.
and
3.3
3.3
Marketing communications must not mislead the consumer by omitting material information. They must not mislead by hiding material information or presenting it in an unclear, unintelligible, ambiguous or untimely manner.
Material information is information that the consumer needs to make informed decisions in relation to a product. Whether the omission or presentation of material information is likely to mislead the consumer depends on the context, the medium and, if the medium of the marketing communication is constrained by time or space, the measures that the marketer takes to make that information available to the consumer by other means.
(Misleading advertising) and
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).
7. Upheld
We considered that most of the studies provided were of a poor methodological quality, with limitations including flaws in the statistical analysis, small sample sizes and short treatment durations.
Furthermore, we considered that "skin conditions" was a very general term that could imply a broad range of conditions that were not covered in the evidence submitted by UCLH: for example, there was no evidence regarding the common skin conditions such as acne, rosacea or skin infections.
For these reasons we concluded that the evidence submitted was not sufficiently robust or wide in scope to substantiate the general claim that Western herbal medicine was suitable for the treatment of "skin conditions".
On this point the ad breached CAP Code (Edition 12) rules
3.1
3.1
Marketing communications must not materially mislead or be likely to do so.
and
3.3
3.3
Marketing communications must not mislead the consumer by omitting material information. They must not mislead by hiding material information or presenting it in an unclear, unintelligible, ambiguous or untimely manner.
Material information is information that the consumer needs to make informed decisions in relation to a product. Whether the omission or presentation of material information is likely to mislead the consumer depends on the context, the medium and, if the medium of the marketing communication is constrained by time or space, the measures that the marketer takes to make that information available to the consumer by other means.
(Misleading advertising) and
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).
9. Upheld
We noted the RCTs submitted in support of this claim, however, the authors of the ginseng study concluded that that study alone was not sufficient in demonstrating the overall efficacy of Siberian ginseng in reducing fatigue. Furthermore, both studies contained a number of weaknesses that limited their usefulness as evidence for the claim. These weaknesses included: small study sizes; short study durations; lack of a demonstration of statistical significance; lack of power calculations; and a lack of detail on methodology and randomisation. For these reasons we concluded that the claim was unsubstantiated and therefore misleading.
On this point the ad breached CAP Code (Edition 12) rules
3.1
3.1
Marketing communications must not materially mislead or be likely to do so.
and
3.3
3.3
Marketing communications must not mislead the consumer by omitting material information. They must not mislead by hiding material information or presenting it in an unclear, unintelligible, ambiguous or untimely manner.
Material information is information that the consumer needs to make informed decisions in relation to a product. Whether the omission or presentation of material information is likely to mislead the consumer depends on the context, the medium and, if the medium of the marketing communication is constrained by time or space, the measures that the marketer takes to make that information available to the consumer by other means.
(Misleading advertising) and
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).
10. Upheld
We considered that one review on Pelargonium sidiodes was effective compared to placebo in the short-term treatment of symptoms associated with acute bronchitis. The other review provided limited evidence for the same extract for the treatment of the symptoms of acute rhinosinusitis. However, the authors were unable to show data to demonstrate efficacy in other forms of acute respiratory infection.
The review on Echinacea provided robust evidence that it had some benefit in decreasing the incidence and duration of the common cold. The report on A. paniculata also provided evidence that it was suitable for the short-term treatment of the symptoms of upper respiratory tract infections. The report on oral elderberry extract was also moderately robust.
We considered that overall the evidence submitted was sufficient to support the use of three specific herbal products for alleviating the symptoms associated with some forms of acute infections, including acute rhinosinusitis, the common cold, uncomplicated upper respiratory tract infections and influenza types A and B. There was also good evidence to support the use of Echinacea as a means of reducing the risk of developing the common cold.
However, we noted that the ad claimed that Western herbal medicine was suitable for the "treatment" of "recurrent infections". We considered that this would be understood by consumers as meaning that Western herbal medicine could treat the cause of recurrent infections, rather than only treating their symptoms. We also considered that "recurrent infections" was a general claim that could refer to a very wide number of infections and that the evidence submitted in support of the claim only covered a small number of these. For these reasons, although the evidence could support clearer and more specific claims about Western herbal medicine and the symptomatic treatment of particular infections, we concluded that the claim made in the ad was unsubstantiated and misleading.
On this point the ad breached CAP Code (Edition 12) rules
3.1
3.1
Marketing communications must not materially mislead or be likely to do so.
and
3.3
3.3
Marketing communications must not mislead the consumer by omitting material information. They must not mislead by hiding material information or presenting it in an unclear, unintelligible, ambiguous or untimely manner.
Material information is information that the consumer needs to make informed decisions in relation to a product. Whether the omission or presentation of material information is likely to mislead the consumer depends on the context, the medium and, if the medium of the marketing communication is constrained by time or space, the measures that the marketer takes to make that information available to the consumer by other means.
(Misleading advertising) and
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).
11. Not upheld
We noted that all of the studies submitted used the inclusion and exclusion criteria recommended by the International Headache Society for studies of migraine prophylaxis. We considered that the reports presented provided evidence that some Western herbal medicines were efficacious in the prophylaxis of migraine. We therefore concluded that the ad did not breach the Code on this point.
On this point we investigated the ad under CAP Code (Edition 12) rules
3.1
3.1
Marketing communications must not materially mislead or be likely to do so.
and
3.3
3.3
Marketing communications must not mislead the consumer by omitting material information. They must not mislead by hiding material information or presenting it in an unclear, unintelligible, ambiguous or untimely manner.
Material information is information that the consumer needs to make informed decisions in relation to a product. Whether the omission or presentation of material information is likely to mislead the consumer depends on the context, the medium and, if the medium of the marketing communication is constrained by time or space, the measures that the marketer takes to make that information available to the consumer by other means.
(Misleading advertising) and
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) but did not find it in breach.
Action
The claims investigated and found to be in breach of the Code must not be used again. We advised UCLH to take care in future advertising not to over claim when making general claims for services using herbal products. Conditions for which some herbal medicines were found to have some effect included: functional dyspepsia, irritable bowel syndrome, premenstrual syndrome, back pain and OA, depression, some forms of acute infections including acute rhinosinusitis, the common cold, uncomplicated upper respiratory tract infections, influenza types A and B and migraine.
