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.
Ad description
A website and Instagram post for Nimaya, a health and wellness clinic:
a. The website www.nimaya.co, seen on 26 June 2023, listed various health conditions including “Long Covid” on the “A-Z Conditions” web page. When that linked text was clicked, a box appeared with text that stated “Long Covid recommended therapies (click to view each therapy and book) Hyperbaric Oxygen Therapy Red Light Therapy Bed”.
On the “Hyberbaric Oxygen Therapy” linked web page, text included “Benefits Hyperbaric Oxygen Therapy has been found to be helpful in treating the symptoms of the following conditions; […] For Your Mind Eases migraine […] Can improve symptoms of Autism and Multiple Sclerosis Helps with recovery after a Stroke […] For Your Body Helps with recovery from Long Covid […] Slows degenerative joint disease Improves symptoms of Osteoporosis”.
On the “Advanced Red Light Therapy” linked web page, text stated “Benefits Advanced Red Light therapy has been found to be helpful in treating the symptoms of the following conditions; For Your Body Helps recovery from Long Covid symptoms”.
b. The post on Nimaya’s Instagram page, posted 14 March 2023, stated “nimayalondon 15 AMAZING reasons why YOU need to book a HYPERBARIC OXYGEN session now! […] it helps recovery from Long Covid […] eases migraines […] improves respiratory conditions […] increases recovery after a Stroke”.
Issue
The ASA challenged whether the:
1. claims in ads (a) and (b) that hyperbaric oxygen therapy (HBOT) and advanced red light therapy treatment could treat long COVID were misleading and could be substantiated; and
2. ads discouraged essential treatment for conditions for which medical supervision should be sought, namely migraine, autism, multiple sclerosis, stroke, degenerative joint disease, osteoporosis and respiratory conditions.
Response
1. Nimaya Mindstation Ltd t/a Nimaya denied that the ads were misleading in claiming that HBOT and red light therapy (photobiomodulation) helped with recovery from long COVID. They said they held documentary evidence in the form of clinical studies from both manufacturers of the HBOT chamber and of the red light therapy equipment, which they provided to their customers via their website. They believed they showed the treatments to be beneficial in helping with recovery from many of the symptoms of long COVID. They provided evidence which included studies related to the use of HBOT and red light therapy which they believed supported the claims in the ads.
2. Nimaya said they did not discourage essential treatment for conditions for which medical supervision should be sought. Neither ad (a) nor (b) made any claim that HBOT replaced the requirement for medical supervision. Their website stated “As with all therapies, the effectiveness of this treatment is likely to be different for everyone and it is suggested that you carry out your own research into the benefits offered”. It also recommended the reader to visit their Resources page that offered a number of links to studies and research for their own information and review.
They said all HBOT treatments were carried out by a person suitably trained and qualified to conduct treatment with HBOT, who had completed the required safety training and instruction certification courses required by the manufacturers to operate their HBOT chambers. They provided copies of those qualifications. Nimaya said no diagnosis as to a medical condition was ever made and they did not seek to advise as to a client’s condition. They only offered a treatment service and every client who underwent HBOT treatment was required to have an induction session that lasted around 1.5 hours, during which it was made clear that the treatment was not a replacement for medical treatment with a doctor. In their treatment waiver, which was signed by each customer, it stated that “Nimaya Mindstation treatment is not a medical or psychological therapy and is not intended as a treatment or remedy for any condition”. It also required customers to state: “I also hereby agree and understand that I shall have consulted with my own doctor prior to having a Nimaya Treatment if I am currently taking any medication or under a doctor's care for any reason, or if I have or ought to have any reason for consulting my doctor before using the treatments offered by Nimaya Mindstation Ltd. I understand that Nimaya Mindstation does not medically diagnose or claim to cure and that their treatments aim to stimulate the body’s own healing mechanisms”.
Assessment
1. Upheld
Ad (a) stated “Long Covid recommended therapies […] Hyperbaric Oxygen Therapy Red Light Therapy Bed”, “Benefits Hyperbaric Oxygen Therapy has been found to be helpful in treating the symptoms of the following conditions […] For Your Body Helps with recovery from Long Covid and “Advanced Red Light therapy has been found to be helpful in treating the symptoms of the following conditions; For Your Body Helps recovery from Long Covid symptoms”. Ad (b) stated “15 AMAZING reasons why YOU need to book a HYPERBARIC OXYGEN session now! […] it helps recovery from Long Covid”.
The ASA considered consumers would understand from the claims that HBOT and advanced red light therapy could treat long COVID and its symptoms. 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 and that red light therapy was a non-invasive low energy light (red and near infrared) therapy.
We first assessed the evidence provided for red light therapy which included two literature reviews, two systematic reviews and an abstract of a literature review. The two literature reviews and two systematic reviews related to the use of red light therapy for the treatment of COVID-19 and not long COVID. The abstract discussed the effects of the microbiome and red light therapy on human health generally. Therefore, we did not consider that the evidence provided was relevant to substantiate the claims in the ads about the treatment of long COVID.
We next assessed the evidence supplied for the HBOT treatment, which included two studies and a news article. We did not consider that the news article, which discussed one of the study’s results of using HBOT in patients with long COVID, met the standard of evidence we 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 or not any of the measured improvements following 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 following 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 considered that the study was insufficient to substantiate the claims in the ads that HBOT could treat long COVID and its symptoms.
Therefore, because we had not seen adequate evidence to substantiate the efficacy claims that HBOT and advanced red light therapy could treat long COVID and its symptoms, we concluded that the ads were misleading.
On that point, 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).
2. Upheld
The CAP Code stated that marketers must not discourage essential treatment for conditions for which medical supervision should be sought. Advertisers must not offer specific advice on diagnosis of or treatment for such conditions, unless that advice, diagnosis or treatment was conducted under the supervision of a suitably qualified medical professional.
Ad (a) stated “Benefits Hyperbaric Oxygen Therapy has been found to be helpful in treating the symptoms of the following conditions; […] For Your Mind Eases migraine […] Can improve symptoms of Autism and Multiple Sclerosis Helps with recovery after a Stroke […] For Your Body […] Slows degenerative joint disease Improves symptoms of Osteoporosis”. Ad (b) stated “why YOU need to book a HYPERBARIC OXYGEN session now! […] eases migraines […] improves respiratory conditions […] increases recovery after a Stroke”. We considered migraine, autism, multiple sclerosis, stroke, degenerative joint disease, osteoporosis and respiratory conditions were conditions for which medical supervision should be sought, and therefore advice, diagnosis or treatment should be conducted under the supervision of a suitably-qualified health professional.
We considered the claims relating to those conditions in ads (a) and (b) would be understood by consumers to mean that Nimaya offered specific treatment for each of those conditions.
We understood that customers were required to sign a disclaimer stating that they had consulted their own doctor prior to receiving treatment and the website also featured disclaimers advising customers to carry out their own research. However, that did not negate Nimaya’s responsibilities to demonstrate that the treatment was conducted under the supervision of a suitably qualified health professional. The evidence they provided was in the form of two certificates that demonstrated the person awarded the certificates had been trained and given instructions about the operation and safe use of hyperbaric chambers. We did not consider that evidence demonstrated that the treatment was conducted under the supervision of a suitably qualified health professional.
Because Nimaya had not supplied evidence that showed their HBOT treatment was conducted under the supervision of a suitably qualified medical professional, we concluded that the ads discouraged essential treatment for conditions for which medical supervision should be sought and therefore breached the Code.
On that point, ads (a) and (b) breached CAP Code (Edition 12) rule 12.2 (Medicines, medical devices, health-related products and beauty products).
Action
Ads (a) and (b) must not appear again in the form complained of. We told Nimaya Mindstation Ltd t/a Nimaya not to state or imply that hyperbaric oxygen therapy (HBOT) or advanced red light therapy could treat long COVID or its symptoms unless they held adequate evidence that substantiated those claims. We also told them to ensure their future ads did not discourage essential treatment for conditions for which medical supervision should be sought.
