Challenging misleading healthcare claims

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

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