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 2023.
Ad description
A website and Facebook post for NUMA, a Hyperbaric Oxygen Therapy clinic:
a. The website www.numaoxygen.com, seen on 26 June 2023, included a page labelled “Conditions”. Text under the “Complementary Therapy” heading stated “A growing number of people who have chronic and debilitating conditions use Hyperbaric Oxygen Therapy alongside their standard medical treatment. Hyperbaric oxygen therapy is an emerging therapy, and so research into its efficacy is ongoing. HBOT is being studied for the conditions listed below […] Emerging Indications: Long Covid […]”.
b. The post on the NUMA Facebook page, dated 8 February 2023, stated “Make sure you’re in the know! Check out our blog post for a detailed breakdown of how HBOT can help with Long Covid Symptoms. Link in BIO Stay informed”. Below was an embedded video with text which stated “HOW DOES HBOT HELP WITH LONG COVID SYMPTOMS? 1. Improves oxygenation 2. Reduces inflammation 3. Induced neuroplasticity Visit our website & blog to find out more (link in bio)”.
Issue
The ASA challenged whether the claims that hyperbaric oxygen therapy (HBOT) could treat long COVID were misleading and could be substantiated.
Response
In relation to ad (b), NUMA Ltd said they were referring to HBOT potentially helping the symptoms of long COVID. In relation to ad (a), they had provided consumers with a disclaimer which stated “However, at this time, neither the FDA (US Food and Drug Administration) nor NICE (National Institute for Health and Care Excellence) had cleared or authorised the use of any HBOT to treat COVID-19 or any emerging conditions beyond those listed above”.
They provided evidence which included studies which they said related to the potential benefits of HBOT use in long COVID. NUMA said they had referrals for patients with long COVID from cardiologists, respiratory consultants, and neurologist colleagues because of that evidence. They ensured that all their patients were thoroughly informed about the potential benefits, side effects and limitations of HBOT and the lack of randomised controlled trials in the field. They provided a screenshot from an anonymised patient file which they said demonstrated their processes.
Assessment
Upheld
Ad (a) stated “A growing number of people who have chronic and debilitating conditions use Hyperbaric Oxygen Therapy alongside their standard medical treatment […] HBOT is being studied for the conditions listed below […] Emerging Indications: Long Covid […]”. Ad (b) stated “Check out our blog post for a detailed breakdown of how HBOT can help with Long Covid Symptoms”. The ASA considered that consumers would understand the claims in the ads to mean that HBOT could treat long COVID and its symptoms. We acknowledged ad (a) stated that research into HBOT's efficacy was ongoing. However, particularly as HBOT was listed on the “Conditions” page under the "Complementary Therapy" heading on the website, we considered that statement did not alter the overall impression that HBOT could treat long COVID and its symptoms. We therefore expected to see robust scientific evidence to substantiate the claims.
We understood from the 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 any alternative diagnosis. Long COVID may consist of a number of distinct syndromes, which could include post-ICU (intensive care unit) 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 three published studies and two case studies.
We had only been provided with the abstracts of the two case studies. They were on the use of HBOT to treat a single individual and six patients, respectively, who had long COVID. Although we had not seen the case studies in full, we considered that in any case, results could not be drawn from such small patient sizes and that the case studies 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 from receiving HBOT were sustained. We considered that the study was insufficient to substantiate the claims in ads (a) and (b).
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.
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, after which there was no follow-up to assess whether any of the measured improvements from receiving HBOT were sustained. Additionally, the study stated that the optimal number of HBOT sessions to achieve maximal therapeutic effect was yet to be determined.
For the reasons stated, we therefore considered that the study was insufficient to substantiate the claims in the ads.
The third study, which we understood was part of the same study population as the one referenced above, followed the same randomised, sham-controlled, double blinded protocol and evaluated the effect of HBOT on cardiac function. In this trial, 60 participants underwent an ECG (echocardiography) exam at baseline and 1-3 weeks after the last session. The results showed a significant improvement in global longitudinal strain (GLS) (a measure of myocardial deformation) in the HBOT group, particularly in those who had reduced GLS at baseline. We understood that of the 60 patients, 29 had reduced GLS at baseline, with 16 and 13 being allocated to the HBOT and sham groups, respectively. Following HBOT treatment, 10 patients (62.5%) from the HBOT group had normalised GLS levels and 5 (38.4%) in the sham group. It was therefore only a proportion of those patients who received HBOT, having had a reduced GLS at baseline, who showed an improvement in GLS – which was only one measure of HBOT’s effectiveness.
We understood that the primary outcome measure of the study was to assess neurocognitive function in long COVID patients and that the effect of HBOT on cardiac function was one of a number of secondary outcome measures. The study was therefore designed primarily to study neuro-cognitive function and we considered that there may be other measures needed to adequately assess cardiac function.
We also considered that the claim “people who have chronic and debilitating conditions use Hyperbaric Oxygen Therapy” in ad (a), suggested that people who had HBOT would experience an overall and general improvement in how they actually felt on a day-to-day basis, rather than improving one specific measure, GLS, which did not affect all participants in the study and may not have demonstrably improved their long COVID symptoms.
As mentioned above in relation to the second study, we considered that the number of participants in the study was small, there was no follow-up to assess whether any of the measured improvements after receiving HBOT were sustained following results obtained 1-3 weeks after the last HBOT session, nor had the optimal number of HBOT sessions been determined.
For the reasons stated, we therefore considered that the study was insufficient to substantiate the claims in the ads.
Therefore, because we had not seen adequate evidence to substantiate the efficacy claims that HBOT could treat long COVID or certain symptoms of it, we concluded that the ads were misleading.
Ads (a) and (b) 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
The ads must not appear again in the form complained of. We told NUMA 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.
