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.
A website and a paid-for search listing for The Hale Clinic, a complementary medicine practise:
a. The website www.haleclinic.com, seen on 26 June 2023, included text on the hyperbaric oxygen therapy (HBOT) webpage that stated “HBOT AND POST-COVID SYNDROME […] around 17% of patients continue to have problematic symptoms up to 3 months after the onset of COVID-19 — even after tests no longer detect virus in their body. This is known as long COVID. The most common symptoms that people with long COVID-19 experience include: Loss of taste and/or smell Sleep issues Tachycardia Gut issues Anxiety Difficulty breathing Joint pain Chest pain Brain fog, including an inability to concentrate and impaired memory Fatigue”. Further text stated “HBOT supplements the amount of oxygen dissolved by body’s tissues following infection and is quickly proving to be a useful method complementary to long COVID treatment, with studies and clinical trials already in place […] Over the past year there have been several people sharing the healing HBO treatment has brought to them after experiencing lingering symptoms of the Covid-19 virus”.
b. The paid-for Google search result, seen during May 2023, featured headline text which stated “Long-Covid Treatment – Accelerates Healing & Recovery”. Further text below stated “HBOT Helps In Alleviating Symptoms Such As Fatigue, Insomnia and More. Hyperbaric Oxygen Therapy (HBOT) - £79 for 60 Minutes. Book an Appointment”.
The ASA challenged whether the claims in ads (a) and (b) that hyperbaric oxygen therapy (HBOT) could treat long COVID were misleading and could be substantiated.
Indiralaxmi Vignesh Ltd t/a The Hale Clinic said they appreciated the importance of ensuring that any advertising claims about medical treatments, including HBOT for long COVID, were fully substantiated and not misleading. They took their responsibilities to provide accurate, evidence-based information to the public seriously. They provided evidence to support their claims about the potential effectiveness of HBOT for long COVID.
The Hale Clinic said that while they believed the studies substantiated their claims, they understood that medical research was a continuously evolving field and they remained committed to updating their understanding and communications based on the latest evidence.
They also said they never presented HBOT as a guaranteed cure for long COVID. Instead, they presented it as a potential treatment option that may provide relief for some patients, based on scientific studies and under the guidance and supervision of medical professionals.
Ad (a) stated “The most common symptoms that people with long COVID-19 experience include: Loss of taste and/or smell Sleep issues Tachycardia Gut issues Anxiety Difficulty breathing Joint pain Chest pain Brain fog, including an inability to concentrate and impaired memory Fatigue" and "HBOT […] is quickly proving to be a useful method complementary to long COVID treatment […] Over the past year there have been several people sharing the healing HBO treatment has brought to them after experiencing lingering symptoms of the Covid-19 virus”. Ad (b) stated “Long-Covid Treatment – Accelerates Healing & Recovery […] HBOT Helps In Alleviating Symptoms Such As Fatigue, Insomnia and More”. The ASA considered consumers would understand the ads to mean that HBOT could treat long COVID and the symptoms of it. We therefore expected to see robust scientific evidence to substantiate the claims.
We assessed the evidence provided which included a published study, two medical press releases and two news articles. We did not consider that the news articles, one of which discussed the results of a study that used HBOT in subjects with long COVID and the other discussed the personal experience of someone who used HBOT for their long COVID symptoms, met the standard of evidence we required for the type of claims being made.
Both press releases discussed the outcomes of the same small, double-blind, randomised controlled trial that measured the effect of HBOT on heart function in patients with long COVID. However, because they were only press releases, and we had not seen the study to which they related, we did not consider that they met the standard of evidence we required for the type of claims being made.
The 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.
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).
The ads must not appear again in the form complained of. We told Indiralaxmi Vignesh Ltd t/a The Hale Clinic 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.