Background
Summary of Council decision:
Two issues were investigated, both of which were Upheld.
Ad description
A website for the Hyperbaric Oxygen Therapy Centre, seen on 15 March 2017, referred to a number of health conditions which it claimed hyperbaric oxygen therapy could treat. It also made several references to "Dr Rob Pender". A tab entitled "FAQS" [sic] at the top of the site led to a page with a list of questions which included "Who is Dr Robert Pender?". It said he applied to study hyperbaric medicine as a post graduate in the USA and gained "a Phd [sic] medical Science and advanced diploma in Hyperbaric Medicine". Another FAQ answer referred to Dr Pender as "our in-house doctor of Hyperbaric Medicine".
Under a tab at the top of the website labelled "Treatments" was a list of what hyperbaric oxygen therapy could be used to treat or assist including candida, chronic fatigue, diabetes, fibromyalgia, hearing loss, infertility and IVF, Lymes [sic] disease, migraines, multiple sclerosis, stroke recovery and "other symptoms". Clicking on "other symptoms" showed a longer list of medical conditions and treatments.
Issue
The complainant, an inspector for the Care Quality Commission, challenged whether:
1. the ad misleadingly implied that Dr Pender was a medically qualified doctor, registered with the General Medical Council; and
2. the efficacy claims that hyperbaric oxygen therapy could treat the following were misleading and could be substantiated: burns, chronic fatigue, fibromyalgia, hearing loss, interstitial cystitis, leg ulcers, peripheral neuropathy, referred pain, sciatica, varicose ulcers and varicose veins, Addison’s and Hasimoto’s diseases, anaemia, diabetes, brain injuries, candida, carbon monoxide poisoning, cognitive disorders in the elderly, heart attacks, infertility and IVF, Lymes [sic] disease, migraines, motor neurone disease, MRSA, multiple sclerosis, stroke recovery, Parkinson’s disease, prostatitis, soft tissue infections and urine infections.
Response
1. Hyperbaric Oxygen Therapy Ltd t/a The Hyperbaric Oxygen Therapy Centre said they would no longer state that Robert Pender was a medical doctor and that they had removed references to his PhD.
2. The Hyperbaric Oxygen Therapy Centre agreed to remove references to some conditions that they claimed to treat because there wasn't sufficient evidence to substantiate those claims. Those conditions were Addison's and Hasimonto's disease, anaemia, sciatica, motor neurone disease and varicose veins.
The Hyperbaric Oxygen Therapy Centre said they made it clear that hyperbaric oxygen therapy (HBOT) was not intended to replace general medicine and encouraged consumers to continue to use their prescribed treatments. They said they planned to create a "log-in" for medical professionals which would contain clinical papers and trials regarding HBOT. In addition, since the ASA contacted them, they had employed a GMC registered consultant, who would carry out initial consultation and medical assessments with all patients. They said they would also remove the word "treat" when they referred to HBOT's application in respect of health conditions.
To support their claims, The Hyperbaric Oxygen Therapy Centre sent a collection of more than 40 studies, systematic reviews, media articles, discussion pieces and textbooks.
Assessment
1. Upheld
The ASA welcomed the advertiser’s assurance to remove the title of doctor from Robert Pender’s qualifications and the reference to his PhD in their marketing. However, we noted that there were still some sections of the website that included a reference to “Dr Pender” and his PhD.
We considered that consumers would understand from the claim “Dr Pender” that he was a qualified and practising medical doctor. Hyperbaric Oxygen Therapy Centre’s website stated that "Dr Robert Pender" was an “early pioneer in the field of hyperbaric medicine”, that he applied to study “hyperbaric medicine” and gained a PhD in Medical Science. However, we understood that Dr Pender was not registered with the General Medical Council.
Because the website gave the impression that Dr Rob Pender was a qualified and practising medical doctor when that was not the case we concluded that the ad was misleading.
On that 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. (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 consumers would understand from the ad that HBOT could treat the list of conditions included on the Hyperbaric Oxygen Therapy Centre’s website.
We considered that a suitable body of evidence would be required to support each of the claims. The Hyperbaric Oxygen Therapy Centre did not provide any evidence to support their claims that HBOT could be used to treat cognitive disorders in the elderly, MRSA, Parkinson’s disease, prostatitis, urine infections, heart attacks, interstitial cystitis, multiple sclerosis, peripheral neuropathy, referred pain, varicose ulcers or assist in IVF treatment. We therefore concluded, in the absence of sufficient evidence, that the claims that HBOT could treat those health conditions were misleading.
Among the evidence submitted by the Hyperbaric Oxygen Therapy Centre was a handbook on hyperbaric medicine, which included information on some of the conditions listed on the website. However, we noted that there was no additional explanation of the book’s relevance in respect of the conditions listed in the ad. We therefore did not consider it was sufficient evidence to substantiate the claims. Some material provided was either not relevant or seemed to contradict the claims.
The Hyperbaric Oxygen Therapy Centre provided three clinical trials, one discussion paper and an online article to support their efficacy claim regarding the treatment of diabetes. The first trial only used 16 patients and the control group were non-diabetic, which we did not consider was robust enough to support efficacy claims. Diabetic patients had also fasted prior to the collection of the results which we considered may have affected the variables. The second trial, which examined whether HBOT could be used alongside a primary therapy for diabetic foot ulcers, did not explore any flaws, limitations or bias and recognised that, while preliminary results were said to be promising, large randomised controlled trials were necessary to establish the efficacy of HBOT in the treatment of diabetic foot ulcers. The third trial also investigated the efficacy of HBOT concerning the treatment of diabetic foot ulcers. However, the trial was not controlled or randomised, only involved four patients and there was no statistical analysis of the significance of the results. The discussion paper stated HBOT’s efficacy in respect of chronic wounds and diabetic foot ulcers was not universally accepted and should only be used in conjunction with a primary therapy. The online article was only a descriptive account of HBOT and did not examine the studies it quoted in detail. In addition, NICE guidance stated HBOT should not be offered to treat diabetic foot ulcers, unless as part of a trial.
The Hyperbaric Oxygen Therapy Centre provided two systematic reviews and two clinical trials to substantiate the claim that HBOT could treat brain injury. The first trial involved only one patient and the advertiser did not clarify where the study was published. The second trial involved only two patients and did not include any statistical analysis or discuss the limitations or flaws of the study. The first systematic review did not definitively state that there was a unified view about the use of HBOT in treating traumatic brain injury (TBI). The review stated that there had been a number of discrepancies among the patients who received it, failures in the research methodology and recognition that the theoretical underpinning had only been successful in animal models. The second systematic review also stated that the use of HBOT among traumatic brain injury patients “remains controversial” and that further investigation “including a multicentre prospective randomized control trial, will be required to definitively define the role of HBOT in severe TBI”. A Cochrane Review, although not submitted by Hyperbaric Oxygen Therapy Centre, found that, in general, the studies it assessed were small and carried a significant risk of bias. None described adequate randomisation procedures, allocation concealment and none of the patients or treating staff were blinded to treatment. They stated that for people with traumatic brain injury, while the addition of HBOT may reduce the risk of death and improve the final (Glasgow Coma Scale) score, there was little evidence that the survivors had a good outcome.
The Hyperbaric Oxygen Therapy Centre submitted a study and an internet article to substantiate the claim that HBOT could be used to treat carbon monoxide poisoning. One study examined the effects on only one patient. We did not consider that an internet article was sufficient to substantiate a claim about medical efficacy. We understood that NHS Choices stated that there was “insufficient evidence regarding the long-term effectiveness of HBOT for treating severe cases of carbon monoxide poisoning”, “HBOT may be regarded in certain situations” and “The use of HBOT will be decided on a case-by-case basis”. NICE guidance also stated that “treatment with hyperbaric oxygen is not currently recommended because there is insufficient evidence that hyperbaric oxygen therapy improves long-term outcomes of people with severe carbon monoxide poisoning, compared with standard oxygen therapy”.
The Hyperbaric Oxygen Therapy Centre provided one study to support the claim that HBOT could be used to treat infertility. However, the study only involved one participant; it only examined secondary infertility; and concluded that further investigation was required before a substantive conclusion could be made.
The Hyperbaric Oxygen Therapy Centre submitted one study to support claims about chronic fatigue. The study was not a randomised-control trial, only involved 16 participants, stated further studies with larger sample sizes were “definitely awaited” and made no firm conclusions about the efficacy of the treatment.
The Hyperbaric Oxygen Therapy Centre submitted one study to support efficacy claims related to the treatment of Lyme disease. However, there was no control group and while results yielded significance, the data was based on self-reported questionnaires which we did not consider was an appropriate measurement tool.
The Hyperbaric Oxygen Therapy Centre submitted two online articles and a Cochrane Review to support their claims regarding hearing loss. The Review assessed the effects of hyperbaric oxygen therapy for idiopathic sudden sensorineural hearing loss (ISSHL). It concluded that although the application of HBOT significantly improved hearing among participants with acute ISSHL in light of the modest number of patients assessed, methodological shortcomings and poor reporting, the results should be interpreted cautiously. The first online article repeated some of the findings of the Cochrane Review but did not include its conclusions. It also included the results of another trial but with no details of the studies inclusion/exclusion criteria, any methodological flaws, or the statistical models used to calculate significance. The second online article included links to other information regarding HBOT and hearing loss but it was not relevant as evidence in support of the claims.
The Hyperbaric Oxygen Therapy Centre submitted a Cochrane Review from 2016 and an online article to support their claims about migraine headaches. The Cochrane Review only found low quality evidence to suggest that HBOT relieved acute migraine pain and possibly cluster headaches. The study concluded that further research was needed to choose which patients, if any, should receive HBOT for migraine. The online article, described one study descriptively, with no analysis of the limitations or flaws of the study, and no clinical significance or statistical analysis. In addition, the study was only carried out among a non-controlled group of 26 patients, so we considered the results could not be generalised to a larger population.
The Hyperbaric Oxygen Therapy Centre submitted two studies to support the efficacy claims regarding strokes. We considered that the number of participants in the first study was relatively small to generalise to a population. The study’s discussion did not explore any of the flaws or limitations of the study, the control group simply received no HBOT, rather than enter a HBOT chamber, and it was not a randomised control trial. In addition, the control group was crossed over and underwent HBOT after no treatment for two months which we considered meant it was not truly blinded and was liable to bias or interference. The second study concluded that more research was needed to make further conclusions about the appliance of HBOT in treating post-stroke patients. A Cochrane Review, not submitted by the Hyperbaric Oxygen Therapy Centre, concluded there was no “good evidence” to show that HBOT improved clinical outcomes among patients with acute presentation of ischaemic stroke and further research was necessary to better define the role of HBOT.
The Hyperbaric Oxygen Therapy Centre submitted one trial to support their efficacy claims that HBOT treated fibromyalgia. It appeared to have been well conducted and reported positive change in terms of quality of life and well-being measures. While there also appeared to be an overall improvement in pain measures, it was difficult to interpret the findings because they related to relative change in pain measurements. The study, conducted with 60 participants divided equally between a treatment group and a control group, was the only evidence provided in support of the claims that HBOT was efficacious in the treatment of fibromyalgia. In the absence of additional evidence, we considered that the claims to treat that condition had not been substantiated and were misleading.
Because the advertiser had not submitted sufficient evidence to support their efficacy claims regarding the health conditions on their websites, we therefore concluded the claims were likely to mislead.
On that 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.
(Misleading advertising),
3.7
3.7
Before distributing or submitting a marketing communication for publication, marketers must hold documentary evidence to prove claims that consumers are likely to regard as objective and that are capable of objective substantiation. The ASA may regard claims as misleading in the absence of adequate substantiation.
(Substantiation) and
12.1
12.1
Objective claims must be backed by evidence, if relevant consisting of trials conducted on people. Substantiation will be assessed on the basis of the available scientific knowledge.
Medicinal or medical claims and indications may be made for a medicinal product that is licensed by the MHRA, VMD or under the auspices of the EMA, or for a CE-marked medical device. A medicinal claim is a claim that a product or its constituent(s) can be used with a view to making a medical diagnosis or can treat or prevent disease, including an injury, ailment or adverse condition, whether of body or mind, in human beings.
Secondary medicinal claims made for cosmetic products as defined in the appropriate European legislation must be backed by evidence. These are limited to any preventative action of the product and may not include claims to treat disease.
(Medicines, medical devices, health-related products and beauty products).
Action
We told the Hyperbaric Oxygen Therapy Centre not to claim or imply that HBOT could treat conditions unless they held adequate evidence to demonstrate that was the case and not to imply that their staff included a qualified and practising medical doctor if that was not the case.
