Background
This Ruling forms part of a wider piece of work on long COVID treatments, identified for investigation following intelligence gathered by the ASA. See also related rulings published on 30 August and 8 November 2023.
Summary of Council decision:
Two issues were investigated, one of which was Upheld. The other was informally resolved after the advertiser agreed to amend their advertising.
Ad description
A website, Facebook post and Instagram post for The Heal-Air, a hyperbaric oxygen therapy provider:
a. The website www.thehealair.co.uk, seen on 26 June 2023, stated on the homepage “Hyperbaric Oxygen Therapy (HBOT) can help treat a wide range of conditions including Long Covid […]”. Under the heading “Core Treatments” text stated “Long Covid” with a button to “FIND OUT MORE”.
On the “Long Covid” web page text stated “Hyperbaric Oxygen Therapy may help alliviate [sic] the symptoms of Long Covid. The severity of COVID-19 can lead to hypoxemia as a result of damage done to lungs through inflammatory responses by the viral infection in the respiratory system. Hyperbaric Oxygen contributes to reverse hypoxemia. In addition, helps [sic] to reduce any leftover inflammation caused by Covid-19, repair any damaged cells starved of oxygen during illness, improve energy levels and reduce pain in the body from inflammation. It’s also possible that small traces of the covid [sic] virus are left in the body and these can be killed off by improved immune functioning that HBOT can deliver”. “Other benefits include: Improving many of the pulmonary, neurological and cardiological symptoms Restoring the biological balance of the cell”. Further text stated “How many sessions will I need? Customers have seen improvements from as little as one session in a hyperbaric chamber with long term recovery being apparent in most between 10-40 sessions”. Below were links to “Clinical Research” and “Media Reports” related to the treatment of Long Covid using hyperbaric oxygen therapy.
b. The Facebook post on The Heal-Air page, posted 20 April 2023, stated “Health Conditions Alleviate your Symptoms […] Hyperbaric Oxygen Therapy may help: Long Covid […]”.
c. The Instagram post on The Heal-Air page, also posted 20 April 2023, was the same as ad (b).
Issue
The ASA challenged whether the claims in ads (a), (b) and (c) that hyperbaric oxygen therapy (HBOT) could treat long COVID were misleading and could be substantiated.
Response
The Heal-Air said they did not use the wording “can treat” in their posts. Instead they said “may” to acknowledge that the effectiveness of HBOT may vary among individuals. They had added a disclaimer to every page on their website, following notification of the complaint, that The Heal-Air did not make any inferences or claims regarding the efficacy or benefits of HBOT and there was no intention implied or otherwise of it being a cure or as being preventative of any disease. It also stated that results could vary and that evidence for its use remained uncertain as it had not been proven through a randomised controlled clinical experiment or trial, the strongest form of scientific evidence by conventional medical standards.
The Heal-Air said that during consultations with their customers, they clearly explained that they did not provide any guarantees of treatment outcomes, which was included in their consultation form, along with their terms and conditions. They provided a copy of their terms and conditions.
They also provided evidence which included clinical trials that they said showed promising outcomes for individuals suffering from long COVID.
The clinic director said they suffered from long COVID and saw improvements in their health after using HBOT. They would make changes to their website, including deleting the long COVID web page, as a result of the ASA investigation.
Assessment
Upheld
The Heal-Air website (ad (a)) stated “Hyperbaric Oxygen Therapy (HBOT) can help treat a wide range of conditions including Long Covid” and “Hyperbaric Oxygen Therapy may help alliviate [sic] the symptoms of Long Covid […] Hyperbaric Oxygen contributes to improve energy levels and reduce pain in the body from inflammation […] Other benefits include: Improving many of the pulmonary, neurological and cardiological symptoms Restoring the biological balance of the cell”. Ads (b) and (c) stated “Health Conditions Alleviate your Symptoms […] Hyperbaric Oxygen Therapy may help: Long Covid […]”.
The ASA considered consumers would understand the ads to mean that HBOT could treat long COVID and alleviate its symptoms. We further considered that they would understand from ad (a) that HBOT could reduce pain caused by inflammation, improve energy levels as well as improve symptoms affecting the heart and cardiac function, brain and nerves. We therefore expected to see robust scientific evidence to substantiate the claims.
We understood from the National Institute for Health and Care Excellence (NICE) website that long COVID was a multi-system condition with a range of debilitating symptoms. Its signs and symptoms continued or developed after acute COVID-19, continued for more than 4 weeks and were not explained by an alternative diagnosis. Long COVID may consist of a number of distinct syndromes, which could include post-ICU syndrome, post-viral fatigue syndrome, long-term COVID syndrome and permanent organ damage. We also understood that HBOT involved breathing 100% (pure) oxygen in a special pressurised chamber.
We assessed the evidence provided which included two studies and three abstracts of studies. The studies, to which two of the abstracts related, assessed the use of HBOT to treat patients with COVID-19 and not long COVID. We therefore considered that those studies were not relevant to substantiate the claims related to long COVID in the ads.
The third abstract related to a case study on the use of HBOT to treat six patients who had long COVID. Although we had not seen the case study in full, we considered that in any case, results could not be drawn from such small patient sizes and that a case study did not meet the standard of evidence required for the type of claims being made.
The first published study, which involved giving ten HBOT sessions over a 12-day period to ten patients with long COVID related fatigue symptoms, measured the change in fatigue and cognitive profile. The results showed a statistically significant improvement to both fatigue and some cognitive outcome measures. However, because the number of participants in the study was small, there was no control group and it was not blinded, we considered that it did not meet the standard of evidence we expected to see. Furthermore, there was no follow-up to assess whether any of the measured improvements following HBOT were sustained. We considered that the study was insufficient to substantiate the claims in ads (a), (b) and (c).
The second study was a randomised, controlled, double-blind trial which evaluated the effect of HBOT in 73 post COVID-19 patients with ongoing symptoms, and in particular their neurocognitive function. Patients received either 40 daily HBOT or sham sessions within a two-month period. Follow-up assessments were performed at baseline and 1–3 weeks after the last treatment session. In those who were treated with HBOT, compared to the control group, there were significant improvements in the primary outcome which was the global cognitive score and the attention and executive function domains, but not in the memory, information processing speed and motor skills domains. Whilst there were also some significant improvements in the HBOT group, compared to the control group, for a number of the secondary outcomes that were assessed using self-reported questionnaires that related to quality of life, sleep, psychological distress and pain, many of the specific domains were not significantly improved. Additionally, there was no significant improvement in their pulmonary function.
We considered that although there were significant improvements in some specific areas of both the primary and secondary outcome measures, there were also areas, which in some instances were closely related to the improved areas, where improvement was not seen.
There were also limitations with the study. We considered that the number of participants in the study was small and the results were obtained 1‒3 weeks after the last HBOT session. Also, there was no follow-up to assess whether or not any of the measured improvements following HBOT were sustained.
For the reasons stated, we therefore considered that the study was insufficient to substantiate the claims in the ads.
Ad (a) also stated “How many sessions will I need? Customers have seen improvements from as little as one session in a hyperbaric chamber with long term recovery being apparent in most between 10-40 sessions”. The studies provided involved giving patients 10 and 40 HBOT sessions, respectively. Notwithstanding that we did not consider that either study was sufficient to substantiate that HBOT could treat long COVID or its symptoms, we also had not seen evidence which demonstrated that HBOT was effective after only one session. Additionally, the study involving 40 HBOT sessions stated that the optimal number of HBOT sessions to achieve maximal therapeutic effect was yet to be determined. Furthermore, as neither study followed patients up for a prolonged period after the treatment, we considered that the evidence did not substantiate that long-term improvements could be achieved with HBOT.
While we welcomed The Heal-Air’s willingness to make changes to their ads, because we had not seen adequate evidence to substantiate the efficacy claims that HBOT could treat long COVID or certain symptoms of it, and that patients would experience long-term recovery, we concluded that the ads were misleading.
Ads (a), (b) and (c) breached CAP Code (Edition 12) rules 3.1 (Misleading advertising), 3.7 (Substantiation) and 12.1 (Medicines, medical devices, health-related products and beauty products).
Action
Ads (a), (b) and (c) must not appear again in the form complained of. We told The Heal-Air Ltd not to state or imply that hyperbaric oxygen therapy (HBOT) could treat long COVID or certain symptoms of it unless they held adequate evidence that substantiated those claims.
