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Herbalism on the NHS: complaint upheld

Our fourth complaint against the Royal London Hospital for Integrated Medicine shows yet another a very fragile evidence base — but what will UCL Hospital Trust do about it?

BelladonnaOf all the complementary and alternative therapies, herbalism remains much the odd one out — there is at least some prior probability that many plants or plant extracts will have a pharmacological effect on humans. Indeed, there is some evidence that some herbal products have beneficial effects. There is, of course, also good evidence that many herbal products are dangerous and can cause severe side effects, even death. And that's ignoring the adulterated and contaminated products.

The appeal to nature fallacy abounds amongst many promoters of herbal products, but natural implies neither efficacy nor safety — each claim must be looked at separately and the evidence considered.

When we came across a leaflet advertising the Western Herbal Medicine service of the Royal London Hospital for Integrated Medicine (part of UCL Hospital Foundation Trust), we wondered if they could substantiate the claims they were making. So we submitted a complaint to the Advertising Standards Authority (ASA), who regulate advertising.

That was three years ago, and, after a long and thorough investigation, the ASA's adjudication on our complaint is published today, upholding 10 out of 11 points.

The leaflet on Western Herbal Medicine 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

 Before looking at the evidence provided, it's worth pointing out the RLHIM's definition:

Western Herbal Medicine usually consists of a bottle of alcohol-based tinctures, with up to five different herbs mixed together.

This brings to mind Prof David Colquhoun's quip:

Herbal medicine: giving patients an unknown dose of an ill-defined drug, of unknown effectiveness and unknown safety.

We will have more to say about the quality of some herbal medicines used at a later date.

Challenged

The ASA challenged each of eleven conditions and asked the RLHIM to provide evidence for all of them.

We can only assume, knowing what was at stake if they were to lose the adjudication, that RLHIM would have ensured that the best evidence available was provided. Indeed, RLHIM stated that:

…the body of evidence supported the claims that herbal medicine could be used to treat the listed conditions.

The ASA and their expert disagreed.

RLHIM provided a total of 69 papers in support of their claims.

For many of the claims, the ASA concluded that while some of the evidence provided supported some specific claims falling within rather broad categories, they concluded that the RLHIM had not provided enough robust evidence, covering a range of conditions that could be inferred from the broad categories listed. For example, for the first category of 'digestive disorders', the ASA rejected the evidence provided for inflammatory bowel disease but were happy with the evidence provided for irritable bowel syndrome and functional dyspepsia. However, the ASA didn't consider that those two latter conditions adequately covered the claim being made for 'digestive disorders'. Accordingly, the ASA concluded that the claim was unsubstantiated and misleading.

Many of the other claims were similarly unsubstantiated because of the broad nature of the claim: urinary disorders, allergies, joint problems, skin conditions and recurrent infections.

No doubt, if they re-publish the leaflet, they will be able to limit their claims to the specific conditions they have good evidence for, but, instead of the rather wide-ranging impression given on the original leaflet, a rewritten one might look a bit sparse.

Evidence

It's instructive to note the assessment of many of the papers that the RLHIM provided. Remember that the ASA require an advertiser to hold — at the time they make it — robust scientific evidence for any claim. It's made very clear that unblinded, uncontrolled, non-randomised trials are likely to be unacceptable. Yet the ASA comments reveal what they thought of much of the RLHIM's evidence:

only a small number of patients and were of a short duration

none included power calculations to demonstrate conclusively whether the treatments were efficacious

all had flaws in their methodology

the test material was not precisely defined

The other RCT also lacked from precise product definition.

The systematic review was also lacking in detail and robustness.

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

a general treatment review looking at complementary and alternative remedies

evidence for Chinese herbal medicine

some studies of poor methodological quality

overall the evidence was not sufficiently robust

half of the studies submitted lacked sufficient details on design, methodology and/or statistical analysis to be considered suitably robust.

Other weaknesses…included small sample sizes, short durations and populations that might not have been representative of the typical patient population

The evidence for the remaining herbal medicines was weak.

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.

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.

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.

the authors were unable to show data to demonstrate efficacy in other forms of acute respiratory infection

It is damning that this is the best evidence that an NHS hospital can come up with for the treatments it provides at the taxpayer's expense. But, even though there is at least a level of plausibility of herbal products, the RLHIM wasn't able to do much better than it was for acupuncture.

skull and crossbones

Kava kava

The RLHIM provided evidence that kava kava was effective for anxiety — even though this was for the claim about stress, not anxiety. However, that would be fine except that the medicines regulator banned the sale, supply and importation of any kava kava based product in 2002 because of widespread concerns about its hepatoxicity. So, even if it is effective, the RLHIM would not have been able to legally prescribe it. The ASA, rightly, rejected this as evidence for the claim.

Migraine

But they were able provide evidence that satisfied the ASA for their claim about migraines, so the ASA did not uphold this point. However, the reports provided for migraine prophylaxis (ie prevention of migraines), not relief of migraines themselves. We argued that a reader would infer from the claim for migraines, that they could provide a herbal medicine that would alleviate a migraine headache. The ASA were not persuaded by our argument.

The Common Cold

In an attempt to substantiate their claim about 'recurrent infections', the RLHIM provided evidence for acute bronchitis, acute rhinosinusitis, acute respiratory infection, the common cold and upper respiratory tract infections. The ASA accepted some of this (including the use of Echinacea for the common cold) and rejected others. However, the ASA noted that the claim was for the treatment of 'recurrent infections' not just these respiratory conditions. The ASA therefore ruled that the claim was misleading.

It should also be noted that, as an NHS hospital, referrals to the RLHIM for treatment can only come from your GP or an NHS consultant. It does not seem likely that a GP would refer you to the RLHIM just because you had a cold — recurrent or otherwise. After all, Echinacea products are easily available from any supermarket.

Action

The ASA upheld the complaint on 10 of the 11 points, declaring that the RLHIM ad breached the CAP Code on no less that 30 counts.

The ASA told the RLHIM:

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.

But, having looked at the evidence supplied, they also said:

Conditions for which some herbal medicines were found to have some effect included: functional dyspepsia, IBS, 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.

So, this should now form part of the guidance for advertisers and we expect CAP to update their guidance. All other advertisers of herbal products should now take note and ensure their websites, leaflets, etc comply.

Treatments

We don't know exactly what papers the RLHIM submitted, although an FOIA request  — or a bit of detective work on Pubmed — would disclose them. But some of the herbal extracts in those papers are identified in the ASA adjudication.

However, what the RLHIM provided was a list of papers that tried to substantiate the claims made in the leaflet: what is not entirely clear is whether the herbal products in those papers are actually the ones used by the RLHIM in their treatments. For all we know, they may provide completely different herbal treatments — indeed, that may be even quite likely given the difficulty they appear to have had in coming up with good evidence.

So, it is left as an exercise for the reader to marry up the products mentioned in their evidence with a list of herbal products stocked at the RLHIM, obtained through an FOIA request earlier this year — this spreadsheet contains all the data.

Taking Stock

Now that we have had three adjudications and one informally resolved case covering four RLHIM leaflets, we can step back and look at how the RLHIM has fared:

 RLHIM CAP Code breaches

Yes. 51 CAP Code breaches from just four leaflets.

The current phase of our complaints about claims made in leaflets published by the Royal London Hospital for Integrated Medicine (the Royal London Homeopathic Hospital as was) is nearing completion. We've already won complaints about their:

Podiatry and Chiropody Marigold Clinic leaflet

Traditional Chinese Acupuncture TCM and Group Acupuncture Clinic leaflets

Medical Clinical Hypnosis leaflet

The RLHIM have also been told to change their claims for craniosacral therapy and reflexology in line with our master complaints.

We did look at their leaflet advertising their homeopathy services, but it made no substantial claims about homeopathy.

This now leaves their website and their leaflet collection looking a little sparse — many website pages (such as their reflexology page) now only link to a login page so that the content is hidden from public view.

These successes have all been through complaints to the ASA. But we have also been using the medicines regulator, the MHRA, and the HCPC (the regulator of podiatrists and chiropodists and other healthcare professions) to ensure that the unlicensed Marigold Therapy products are only used and advertised by those legally entitled to do so. Since most podiatrists and chiropodists are not permitted to supply unlicensed medicines, we reported 39 websites advertising Marigold Therapy to the HCPC and we will report more on this part of the campaign in a future newsletter.

signsInappropriate bedfellows?

But of course, this is not just about the words they use in their leaflets or on their website.

At what must surely be the most prestigious and highest-profile organisation promoting and using all sorts of alternative therapies, it should have been straightforward for them to defend the claims they made. But as we've already seen, they were unable to provide the quality of evidence required by the advertiding regulator.

What is more worrying is the potential lack of good evidence for the treatments they use on their patients.

This cannot be good for the public who are referred to the RLHIM: if they don't have the evidence for the treatments they provide at the tax-payer's expense, then why are they providing these treatments at all?

And, as one of the hospitals within University College London Hospitals NHS Foundation Trust, their Board of Directors and Governing Body must now ask important and long-overdue questions about the evidence base for all treatments provided at the RLHIM.

They may have simply tolerated the historical anachronism that is the RLHIM up till now, but, after this latest round of embarrassment for UCLH, it is surely about time these fundamental and serious questions were asked and decisive action taken.

23 October 2013

Landmark decisions for homeopaths

giveway

This is a bleak day for homeopaths; but a victory for consumer choice

Today sees the publication of two long-awaited adjudications by the Advertising Standards Authority (ASA).

One is the second of the ASA's 'master' homeopathy complaints, intended to set the precedent for future claims about homeopathy.

But this is no ordinary complaint about a homeopath making a few silly claims: it is an upheld adjudication against the Society of Homeopaths (SoH), the UK's most prominent homeopath membership organisation, boasting over 1,400 members.

The other is the revised adjudication of H:MC21's advert in New Statesman in 2010 after their appeal of the first ruling.

Although these rulings are not what homeopaths might have hoped for, they set the precedent for claims the ASA will and will not accept in adverts for homeopathy and the standard by which all others will now be judged.

Homeopaths now have the opportunity to finally fall into line and abide by the same rules as everyone else. The Society of Homeopaths have taken the lead by removing their What can homeopathy help? web page (cached).

But first, a look at these two crucial adjudications.

Second's out...

A long time ago, we suggested that our supporters submit complaints to the ASA about claims made on homeopathy websites. To cut a long story short, the ASA sent letters to these homeopaths (letter 1, letter 2 and letter 3) and then produced detailed guidance on advertising homeopathy services. After considering the matter, they also decided to investigate two 'master' complaints to examine all the evidence and to set a precedent for others to follow.

The first of these was Steve Scrutton Homeopathy and the ASA ruled that his website breached their CAP Code on four counts and stated:

The web pages must not appear again in their current form. We told Steve Scrutton to ensure he held robust evidence when making claims in future, and to ensure that he did not offer, in a marketing communication, specific advice on, or treatment for, conditions for which medical supervision should be sought. We advised him to contact CAP Copy Advice for advice on amending his marketing material.

You can judge for yourself whether his website now complies and you could also check his Twitter feed — also regarded as marketing communications by the ASA.

We have been waiting for the ASA's final adjudication and it is published today.

This complaint was not submitted by us, so we had no idea which website was was being investigated; we now know it was the website and a Tweet of the Society of Homeopaths and the ASA identify themselves as challenger of the claims.

At the start of this week, we noticed that the Society of Homeopaths deleted their web page titled What can homeopathy help? (cached). We now know why.

It used to make all sorts of claims about homeopathy, the 'growing body' of evidence for its efficacy and listed several medical conditions:

To date, conditions for which the majority of clinical trial findings have been positive include:

  • 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

The ASA asked for evidence to support these claims — and found it wanting; not measuring up to the high standards we expect and deserve from a body charged with protecting the public from misleading claims.

All in all, the ASA investigated 16 points — the 14 conditions specified and two points about discouraging medical treatment — and upheld all of them, ruling that the SoH breached the CAP Code on no less than 35 counts.

One interesting point is that they supplied some evidence not written in English. When asked to provide translations, the SoH didn't provide translations when requested.

For one claim, the SoH provided evidence for Boiron's Oscillococcinum product, claimed to help with flu symptoms. What is interesting is that Oscillococcinum is classed as an unlicensed homeopathic 'medicine' in the UK and as such, we understand, it can only be prescribed by medical doctors. We also understand it is illegal to advertise it.

The adjudication is thorough, describing how the SoH responded and what evidence they supplied to substantiate the claims made — it is well worth reading in full.

Overall, it is a resounding defeat for all homeopaths as well as the leading homeopaths' trade body; but it also is a resounding victory for consumer protection.

Pseudo science from the 18th century

The other adjudication published today is the end of a long saga that started in 2010 when H:MC21 (Homeopathy: Medicine for the 21st Century) placed a full-page advert in the New Statesman. It attracted six complaints to the ASA. The ASA considered the complaint as 12 separate points and examined the evidence provided by the advertiser to substantiate their claims.

The ASA published their adjudication on 15 October 2011, upholding seven of the 12 points.

The points they didn't uphold included ones that denigrated Prof Edzard Ernst and the House of Commons Science and Technology Select Committee for their Evidence Check report on homeopathy. But that wasn't because they had not been denigrated by the advert, but simply because they did not fall within the categories of those protected from denigration under the ASA's CAP Code.

There were a couple of other more minor points that weren't upheld: we think they should have been upheld, but we felt that because it had already taken 12 months to investigate, it wasn't worth pursuing any further and wasting yet more of the ASA's time.

However, the main claims made by H:MC21 were about the the 'success' of homeopathy. They did provide lots of information about homeopathy and their beliefs about Evidence-Based Medicine and Randomised Controlled Trials, but didn't provide the necessary standard of evidence required by the ASA to substantiate the claims about homeopathy.

This should not have been unexpected: the ASA's standards for substantiation are very clear and well-known, so there can be no excuse for not understanding whether evidence is likely to meet the ASA's standards.

However, having not been provided with adequate evidence, the ASA upheld most of the points, ruling the ad breached the Code on no less than 20 counts.

Appealing

As is their right, the advertiser requested that the case be referred to the Independent Reviewer, Sir Hayden Phillips. They supplied him with an 18-page document detailing the minutiæ of the ASA's handling of the case and what they believed was wrong with it as well as a copy of an article from the Radio Times and information from the British National Formulary about paracetamol.

The advertiser also supplied additional new 'evidence' for their claims, including the oft-cited and oft-misrepresented 'Swiss Health Technology Assessment' on homeopathy. The report, titled 'Homeopathy in Healthcare', was no such thing of course, and no matter how many times it's pointed out that the Swiss Government had to declare that it was not an HTA and that it was published 'without any consent of the Swiss government or administration', it is still represented by many homeopathists as being the definitive, independent, neutral, authoritative report on the 'effectiveness, appropriateness, safety and costs' of homeopathy. It most certainly is not.

Since this report was not published until long after the advert, it cannot be used to substantiate any claims: advertisers must hold the necessary substantiation at the time they publish the advert. Despite this, the ASA examined the report and in their revised adjudication, concluded:

After seeking expert advice, we considered that 'Homeopathy in Healthcare' did not move the case forward in favour of the efficacy of homeopathy in treating medical conditions, in light of conventional standards for efficacy. We noted that proponents of the homeopathic approach often objected to conventional medicine's focus on RCTs as the gold standard for assessing efficacy, and instead they favoured other forms of measurement in their assessment, such as patient self-analysis and outcome studies. Nevertheless, we continue to expect claims, that a particular medicine or approach could be used to treat medical conditions, be substantiated with a robust body of evidence, consisting of RCTs conducted on human subjects, where appropriate. We did not consider the alternatives put forward, such as patient self-analysis or outcome studies, alone to be suitably robust to support efficacy. because 'Homeopathy in Healthcare' did not include robust evidence, of the type we considered necessary, we considered it was insufficient to substantiate the efficacy claims made in the ad.

Sir Hayden considered all the evidence and new submissions. He asked the ASA to re-open the case and consider a few points. This they did and made some minor changes to their original adjudication, mostly consisting of small amendments to the wording surrounding H:MC21's submission and some clarification, spelling and grammatical corrections. But it essentially remained the same, with the same seven points being upheld.

Coincidentally, the revised adjudication is also published today.

Maintaining standards

Aware of the impending outcome, H:MC21 organised a protest outside the ASA's offices and a lobby of Parliament last week, trying to make this protest not just about their advert, but about restrictions on choice in medicine and seemingly wanting the ASA to consider anecdotes over more robust evidence.

They claim the ASA is denying the public the choice of homeopathy for their healthcare. That's completely wrong, of course: the ASA is there to prevent the public being misled by claims made in adverts. This is, unfortunately, much needed, whether it's an advert for washing powder, cheap flights, yoghurt or homeopathy and the same rules apply to everyone.

Regardless of what homeopathists might want the ASA's CAP Code to say, the same rules have been there for years: advertisers should have been perfectly aware of the conditions they needed to meet to ensure they were compliant and their adverts were 'legal, decent, honest and truthful'.

The issue of consumer 'choice' is just a common trope. The real issue is simply whether the advertiser can properly substantiate the claims made. And by ensuring advertisers can substantiate the claims they make, consumers are protected from misleading advertising that would otherwise deny them from making a fully informed choice. We want consumers to be allowed to make that informed choice.

H:MC21 used the following as a slogan in one of their protest leaflets:

Don't let advertisers restrict your choice in healthcare

That's something we wholeheartedly agree with, but we suspect that's not quite what H:MC21 meant. It is advertisers who restrict choice by giving misleading information or omitting vital information.

The end of the road

We have little doubt that these advertisers will have pulled out all the stops to provide the ASA with the best, most convincing evidence for homeopathy available from anywhere, whether RCTs, pilot studies, customer satisfaction surveys, magazine articles (peer reviewed or not), published in any journal, magazine, newspaper, leaflet or comic, and consulted the best homeopathy experts the world over.

They will have known what was at stake here: the claims that homeopaths will from now on be now able to make on their own websites, in adverts in magazines, in newspapers, in leaflets and in banner and search ads on the Internet.

We think the ASA has been very patient throughout this tedious process — it must have been a mammoth task for them and no wonder it has taken more than two years. But it's at an end now.

They have carefully examined all the evidence provided to them, rightly applying the same standards as they do to other advertisers, and have come to a decision that is no different to what we have known for a long time: there is no evidence of a sufficiently high standard for homeopathy that substantiates any claims for any medical condition.

To now make any such claim will be a breach of the rules.

advice

Showing leadership

Homeopaths must now understand that they have to live up to their responsibilities and abide by the CAP Code, ASA guidance and rulings and stop claiming that homeopathy is effective for any medical condition or other misleading claims.

But no one should misunderstand or misinterpret any of this: no one is stopping any homeopath from practising — not us; not the complainants; not the ASA. This isn't about stopping anyone calling him/herself a homeopath, earning a living from homeopathy, selling homeopathic products and it does not stop anyone from visiting a homeopath or buying these products and services if that's what they want to do.

What this is about — and what this is only about — is ensuring homeopaths comply with the same rules all other advertisers have to abide by.

Additionally, the ASA did not ask us our opinion of the evidence; nor did we expect them to. The ASA are perfectly capable of assessing scientific evidence and making these decisions themselves.

Now that the ASA's position is settled, we look forward to all homeopathy advertisers realising that they have no choice any more but to live up to their responsibilities and comply with the ASA's rulings and guidance and cease making misleading claims. The ASA's free Copy Advice Service might be useful.

We hope homeopaths will follow the good example set by the SoH and that the other homeopathy trade bodies will quickly follow suit and boldly face up to their responsibilities, issue clear instructions to all their members that they must abide by the ASA's guidance. And they must enforce it. No ifs; no buts; no woolly weasel words; no disclaimers; no abdication of responsibilities.

The public has been misled for long enough. It's time to stop.

03 July 2013

Homeopathy: Pseudo Science of the 21st Century?

keyboardNearly three years ago, a homeopathy advocacy group calling themselves H:MC21 (Homeopathy: Medicine for the 21st Century) placed an advert in the New Statesman. It attracted six complaints to the Advertising Standards Authority (ASA) about claims it made.

It mentioned Prof Edzard Ernst and he responded in the next issue. In an article titled A bitter pill to swallow, he said:

Rarely had I seen an advert so inaccurate and borderline libellous in a respected publi­cation. The advert, which appeared to breach the British Code of Advertising, was by a lobby group called Homeopathy: Medicine for the 21st Century (H:MC21). It contained unjustified attacks on myself and colleagues, including statements that gave a dangerously false impression of homoeopathy's therapeutic value.

The ASA adjudicated on 12 points and their Council upheld seven of them. It was published on 5 October 2011.

Independent review

H:MC21 requested a review of this decision by the Independent Reviewer, Sir Hayden Phillips. During the lengthy appeal process, the adjudication was removed from the ASA's website as is normal practice.

H:MC21 submitted a large number of points to be considered by Sir Hayden. After carefully considering these, he asked the ASA to re-assess the adjudication on some points. This they did and, because we were one of the six complainants, we now have the revised draft adjudication that will be presented to the Council and will be published shortly. However, because it has not yet been published, we cannot divulge any details. The ASA Council's new decision in now final, although H:MC21 say they would like to raise 'a fighting fund' to challenge it.

Suffice to say, H:MC21 have organised a protest outside the ASA's offices followed by a lobby of Parliament on Tuesday 25 June.

They have also asked supporters to write to their MP and local press, claiming that the ASA is not judging them fairly, is effectively denying patient choice and requesting that "this issue be raised in Parliament". They claim that the ASA:

…is not basing its decisions on "the available scientific knowledge" [for homeopathy]…Instead of looking at all the evidence in context, the ASA appears to be making decisions on the basis of a narrow ideological position. This position is in contradiction to scientific knowledge, in contradiction to the paradigm of evidence based medicine (EBM) and in contradiction to good medical practice.

They ask their supporters to tell their MP that they consider the ASA's approach to be:

…dangerous to the health of patients.

Our supporters will recognise the kind of arguments H:MC21 are trying to use and we doubt any critical-thinking MP would be persuaded by them as many are simply fallacious or have nothing to do with the question at hand: is their advert 'legal, decent, honest and truthful' and can the advertiser substantiate their claims?

Although we believe most MPs will be well aware of the independence, impartiality and well-deserved reputation of the ASA and will therefore not take what H:MC21 are saying about the ASA seriously, there is a possibility that they will be influenced by their constituents' emails.

Action Alert!

So, we would like our supporters to contact their MP to make sure they are aware of the professionalism and impartiality of the ASA and their ability to critically evaluate scientific evidence.

Mass identical emails to MP are seldom effective, so we would like our supporters to write a short individual email.

Please use your own words as they will have the greatest impact, but to help, we would like to suggest a few points you might like to mention:

  • The ASA are there to protect the public from misleading claims and are highly respected for their independence, professionalism and their fair and impartial adjudications.
  • Misleading adverts, particularly about healthcare treatments, can cause harm to the public and prevent them from making fully informed healthcare decisions.
  • The same rules apply to all advertisers and there is no justification in lowering standards for one group, particularly those advertising healthcare therapies.
  • There is no scientific controversy surrounding the evidence for homeopathy: it is clear that, taking the best, most robust, most independent studies, homeopathy is no more effective than placebo.

You can write to your MP directly, or use the convenient Write to Them website: all you have to do is enter your postcode below and click on Submit and you will be taken directly to the Write To Them website.

The protest and lobby are next Tuesday, so try to get your email sent before then!

If you see any letters or articles in your local press, please also consider replying to those.

alertPlease let us know if you do write to your MP, please tell us what reply you get and consider updating your MPs entry in Skeptical Voter's wiki.

 

Contact Your MP
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20 June 2013

Getting the point

needlesYet another adjudication against the Royal London Hospital for Integrated Medicine upheld by the ASA

As previously reported, we won an Advertising Standards Authority (ASA) adjudication against the Royal London Hospital for Integrated Medicine (RLHIM) for claims they were making in their leaflet on hypnosis and an informally resolved case over their marigold therapy leaflet.

We have now had another complaint upheld — this time against claims in their leaflets on acupuncture.

Like the other complaints we have submitted, this one has taken a long time to resolve. Over two years, in fact.

There were actually two leaflets being considered here: Traditional Chinese Acupuncture (TCM) [sic] and Group Acupuncture Clinic.

Their Traditional Chinese Acupuncture leaflet claimed:

Who can benefit from TCM acupuncture?

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)

Their Group Acupuncture leaflet claimed:

At the Royal London Hospital for Integrated Medicine, 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

A plethora of evidence

The RLHIM tried to defend the claims they were making in both leaflets and submitted 43 papers for the ASA and their expert to consider:

  • 19 published reports of acupuncture trials
  • 16 systematic reviews or meta-analyses of acupuncture trials
  • 6 papers relating to the cost-effectiveness of acupuncture
  • one guidance document from the National Collaborating Centre for Primary Care (NICE)
  • an article, published in the British Medical Journal (BMJ), which discussed evidence based medicine.

Through a Freedom of Information Act request, we now know what these documents were and we have some of the correspondence.

These documents covered 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.

They covered several conditions that they hadn't made claims for and certainly didn't cover all the ones they were making claims for! And we never questioned whether acupuncture was cost effective.

The ASA rejected some of the documents, saying:

  • …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 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.

Even though they tried to submit it as evidence, the NICE guidance on lower back pain [1] has been much criticised [2-4].

Although not published until well after the leaflets, the RLHIM submitted the 2012 Vickers et al. meta-analysis. [5] Because evidence cannot be 'back-dated', it was inadmissible as evidence for the claims they had made. Besides, this paper has been roundly criticised and has been grossly misrepresented by proponents of acupuncture. [6]

There were several other papers provided that were not published until after the leaflet and were therefore inadmissible.

Assessment

The RLHIM offered to remove some of the claims:

RLHIM agreed that some of the claims in [the Traditional Chinese Acupuncture leaflet] 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 [the Traditional Chinese Acupuncture leaflet] 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".

The ASA acknowledged RLHIM's offer to:

…remove references to a number of conditions from the the Traditional Chinese Acupuncture leaflet 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.

RLHIM had proposed to include in [the Traditional Chinese Acupuncture leaflet] a statement that acupuncture could provide “improved wellbeing in chronic illness”. We considered general claims that acupuncture could help “wellbeing” would not be problematic, but by linking “wellbeing” 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 ASA assessed the evidence provided for the remaining claims:

Of the remaining 35 papers, we assessed 15 and the remaining 20 were sent to an independent expert for their 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.  

Missing out relevant evidence is never a good idea.

Flawed

The ASA and their expert assessed the evidence and found serious issues with just about all of it as substantiation for the claims that the RLHIM had made.

Some examples of the flaws the ASA found with the evidence provided:

Because the paper was published after [the leaflets] were 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 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 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.

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.

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.

Some studies did provide some evidence for the short-term relief of some conditions, but, because the leaflets did not restrict the claims to short-term relief, the ASA did not consider they had provided the necessary evidence.

It is not clear why it was thought that such obviously flawed evidence would have been acceptable to the ASA. We can only assume — particularly given the length of time this investigation has taken and the prominence of the RLHIM — that they will have provided all the evidence they were able to find in an attempt to defend the claims. Even if they provided inadequate evidence at first, they had ample opportunity to submit better evidence to support their claims.

In summary, the RLHIM:

  • Agreed to remove some claims for which they had no evidence.
  • Provided evidence for conditions they hadn't claimed.
  • Provided evidence about the cost-effectiveness of acupuncture, not its efficacy.
  • Provided a NICE document that recommended acupuncture, but didn't constitute evidence of efficacy.
  • Provided a BMJ article on evidence based medicine, which wasn't evidence for the claims being made.
  • Provided some Cochrane systematic reviews of acupuncture, but since they didn't supply all of those available, the ASA had to provide them to their expert.
  • Offered to add in some words about improved 'wellbeing in chronic illness', but even those were problematic for the ASA.

Adjudication

The ASA's adjudication is lengthy, running to some nine pages and four-and-a-half thousand words. In it, they carefully consider each of the claims made and whether the evidence provided was sufficient to substantiate them.

It wasn't.

This adjudication now sets the standard for acceptable claims made for acupuncture and we expect to see the ASA's advice on acupuncture updated fairly soon.

Because all the claims in both leaflets were taken together as one point to be adjudicated on, there was just three breaches of the CAP Code overall:

The ads breached CAP Code rules 3.1 (Misleading advertising), 3.7 (Substantiation) and 12.1 (Medicines, medical devices, health-related products and beauty therapies).

The ASA concluded:

[The leaflets] 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. 

The ASA's rules are there to protect the public from misleading claims.

We hope all acupuncturists now get the point.

 

References

1 NICE. 2013. “CG88 Low Back Pain: NICE Guideline.” Accessed June 11. http://publications.nice.org.uk/low-back-pain-cg88.

2 “NICE Falls for Bait and Switch by Acupuncturists and Chiropractors: It Has Let down the Public and Itself.” 2013. DC’s Improbable Science. Accessed June 11. http://www.dcscience.net/?p=1516.

3 “NICE Fiasco, Part 2.  Rawlins Should Withdraw Guidance and Start Again.” 2013. DC’s Improbable Science. Accessed June 11. http://www.dcscience.net/?p=1542.

4 “The NICE Fiasco, Part 3. Too Many Vested Interests, Not Enough Honesty.” 2013. DC’s Improbable Science. Accessed June 11. http://www.dcscience.net/?p=1593.

5 Vickers AJ, Cronin AM. 2012. “Acupuncture for Chronic Pain: Individual Patient Data Meta-analysis.” Archives of Internal Medicine 172 (19) (October 22): 1444–1453. doi:10.1001/archinternmed.2012.3654.

6 “An Acupuncture Meta-Analysis.” 2013. Science-Based Medicine. Accessed June 11. http://www.sciencebasedmedicine.org/index.php/an-acupuncture-meta-analysis/.

 

Further reading

Acupuncture is a theatrical placebo: the end of a myth

What alternative health practitioners might not tell you: Acupuncture

12 June 2013

Endemic problems with CNHC registrants

foldersWe have today submitted a batch of 100 complaints against registrants of the Complementary and Natural Healthcare Council (CNHC) for making questionable claims on their websites.

We have to thank our supporters for their sterling work in gathering the information we needed for these complaints. Some of you (you know who you are!) went above and beyond the call of duty to submit dozens to us. We are grateful for them all. This batch of 100 is just a selection of the hundreds you sent us, but will suffice for now.

Thanks also to those who submitted their own claims directly to the CNHC — they all help emphasise to the CNHC the extent of their problem and the extent of the concerns about them and their registrants.

What your efforts have demonstrated is that there are many websites of CNHC registrants that make claims that do not appear to be in compliance with the appropriate therapy descriptor, CNHC advertising guidance, the ASA's CAP Code, ASA/CAP Guidance and ASA adjudications.

Some, we believe, are even illegal, with claims about cancer and using the protected title 'physician'. Most proudly display the CNHC's 'quality mark'.

Claims

The breadth of these questionable claims is truly staggering, with just about no CNHC 'discipline' left untouched. The Alexander Technique is a notable exception in this batch of complaints — at least there is some good evidence for it for some conditions and we found no evidence of the outrageous claims that were being made for other disciplines.

For example, many hypnotherapy registrants are claiming to treat Irritable Bowel Syndrome (IBS), when the ASA have made it clear (as a result of our complaint about the Royal London Hospital for Integrated Medicine) that references can only be made to hypnotherapy helping the pain or discomfort of IBS, not to being able to help IBS itself.

But the problems go much deeper than this. Far more worrying were claims to be able to treat cancer, possibly in breach of the Cancer Act 1939. For example, this, by a 'Healer':

It is vitally important never to lose sight of the fact that any kind of cancer can be healed in a split second, regardless of how far advanced it is or how many areas of the body are affected... For energetic healing it is unimportant where the cancer has manifested or how many parts of the body have been affected. Once the client is embracing the healing process fully, all cancer vanishes, for it no longer has any reason to exist within the person's physique...

Some amazing results have been achieved during the last few years whilst treating people with cancer. Scans often left oncologists amazed. Gradually I am specialising more and more in cancer treatments. Do realise: there is always hope, light, love and therefore possible healing.

Another Healer:

What it can heal

Your physical health; all kinds of aches and pains such as;

more serious illness such as cancer

A naturopath:

Specialist Areas
Skin Problems, Women's Health, Life-Long Weight Loss, Joint & Muscle Pains, Digestive Disorders/IBS, Hayfever Prevention, Tiredness/Energy Levels, Stress, Anxiety & Mental Health, Cancer Prevention & Support

Even yoga therapists:

Yoga Therapy requires no previous yoga experience and is beneficial for a great variety of conditions including RSI, hypertension, migraine, depression, cancer, diabetes, low back pain, IBS, MS, fribromyalgia , menopause, ME, sports injuries, asthma, and Parkinson’s disease.

Many other registrants' websites were making more subtle claims about cancer and frequently about the symptoms of cancer, but still very possibly misleading.

That last list is not untypical of many websites of many different disciplines. One 'Microsystems Acupuncturist' had an impressive list of 80 medical conditions her clinic could supposedly treat.

Others were making some very curious claims. One hypnotherapist:

For some years now I have used methods pioneered by Spanish surgeon, Dr Angel Escudero - who performs ALL of his operations WITHOUT anaesthetic.  His patients are fully conscious throughout the surgery and feel no pain, and as no chemicals are used their bodies heal faster than patients who undergo traditional surgery. To date he has performed thousands of operations - many of which are major - and has no episodes of post-operative infection.

Another:

Breast Enlargement... (No, don't laugh - this really works!)... The earliest report I could find on the successful use of hypnosis to increase breast size dates from as far back as 1949, when it was used with 20 women aged from 20-35. An amazing 17 out of 20 women showed some increase in size, from about one to one and a half inches (2.5-3.7 centimetres) and 5 showed growth of about 2 inches (5 centimetres)..."Dr. Peter Mutke, who has helped pioneer breast enhancement using hypnosis, reports in his book' Selective Awareness' working with 25 women over 10 once a week sessions backed up by cassette tapes. By the end of the tenth week, 20 of the 25 women had experienced a measurable increase…Imagine the thrill of seeing your new self, hearing the compliments, noticing admiring looks and how wonderful it is to have a much higher sense of self-esteem. Why not enlarge your breasts naturally using hypnosis?..."

But you also found several practitioners using the title 'Dr' or the protected title 'physician', when they are not registered with the General Medical Council. Many of the claims being made may also breach consumer protection regulations.

Next steps

The CNHC now need to process this batch of 100 complaints and no doubt that will take some time. However, they can be left in no doubt that they have a very serious problem on their hands and one they must promptly and decisively deal with.

This isn't just a couple of rogue registrants making claims that are slightly misleading: the problem is widespread and runs deep with some making very worrying claims indeed. The level of misinformation being presented to the public is shocking.

We have no doubt that many CNHC registrants are very aware of their responsibilities and want to comply with all the rules surrounding advertising, abide by the law and do so very happily. They are not the problem.

It's difficult to understand how any CNHC registrant can claim to be unaware of their responsibilities — the therapy descriptors have existed for over a year in some cases, and the ASA's CAP Code has been around for over 50 years. There is no excuse for being ignorant of the law.

But all this is happening on the CNHC's watch. It is up to them to ensure their registrants comply with the rules, taking swift and decisive action as and when necessary and monitoring its registrants to ensure they do not stray.

Fit for purpose?

But why is this so important?

Maybe a member of the public will just waste some money and an afternoon visiting a registrant for some treatment that doesn't do what was claimed. That is bad enough. However, given the claims for many serious medical conditions being made, the results of someone relying on what a registrant advertises or tells them could be far more serious — and, in the extreme, potentially fatal, particularly if they delay or forgo possibly urgently needed medical treatment, from a qualified medical practitioner. 

It is now up to the CHNC — if it is ever wants to be considered a regulator that protects the public rather than its registrants — to take this opportunity to tackle the endemic problems with their registrants head on, ensure that all misleading (and indeed illegal) claims are removed and the registrants dealt with appropriately.

But of course, they must do much more than that if the public is to be protected in the future.

The CNHC control what training is considered appropriate for an aspirant registrant and they must also ensure that future registrants are clearly taught during their training just what they can and cannot treat — and that has to be based on the best scientific evidence available. Anything less is a dereliction of their duty. They promised this nearly four years ago, but even if they have taken take action, our complaints clearly demonstrate that it was wholly inadequate.

Standards? What standards?

The CNHC recently applied to the Professional Standards Authority (PSA) to join their statutory Accredited Voluntary Register (AVR). With these revelations of the widespread and reckless claims being made by CNHC registrants, we suggest the PSA drop their application and have nothing further to do with them until the CNHC are able to fully demonstrate their ability to control their registrants and protect the public.

28 May 2013

CNHC Campaign: one final push

clockWe've had a great response to our campaign from many of you, with one person submitting more than 20 websites he found making claims that go against the CNHC's advertising guidance and the ASA's CAP Code.

But we'd like more — as many as you can give us — to show that the problem isn't confined to just a few practitioners.

So, either submit complaints yourself or send them to us:

  1. Find a few minutes over the weekend or the coming week to look up one or more CNHC registrants near you.
  2. Check their website for claims you think breach the CNHC advertising guidance, their therapy descriptors and the ASA's CAP Code and advice (essentially just about any mention of a medical condition).
  3. Fill in our very simple online form and hit 'Submit'.

That's it! We'll take care of the rest.

This is a great and simple way to support us and do your bit to curb misleading claims.

Click here for further information or go straight to the form to get going.

10 May 2013

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