Ad description
A leaflet for First Contact Health, seen in August 2022, featured a headline which stated “PRP INJECTIONS”. Underneath that, text stated “A new and alternative solution to repair damaged tissue, ligaments and arthritic joints”, alongside an image of a knee joint.
On the reverse of the leaflet, text stated “Platelet Rich Plasma (PRP) consists of two elements: plasma, or the liquid portion of blood, and platelets, a type of blood cell that plays an important role in healing throughout the body. The concentration of platelets contain growth factors that can trigger cell reproduction and stimulate regeneration of damages tissues. These are extracted from your blood and injected into the area of damaged tissues to help with the healing process.”
Further text stated “We can use PRP to treat: Osteoarthritis, tendon problems (such as tennis elbow and Achilles tendonitis), torn ligaments and muscles […] This PRP is then injected into the affected area. For arthritic joints, Hyaluronic Acid (HA) is added to the PRP, which is a natural joint lubricant. All this is done in clinic during your appointment and takes up to 30 minutes in total. For best results, 3 injections are recommended over a 6-week period.”
Issue
A doctor, who understood that PRP and hyaluronic acid were not scientifically proven to treat osteoarthritis, tendon problems or torn ligaments and muscles, challenged whether the efficacy claims for PRP injections were misleading and could be substantiated.
Response
First Contact Health said that PRP and hyaluronic acid injections were a well-recognised treatment for arthritic joints, as well as tendon and muscle problems. The products they used for the advertised treatment were CE-marked medical devices and provided that certification. The claims they made were in line with the claims made by the manufacturer of the advertised treatment. They understood that those claims had been approved by the MHRA as part of the CE-mark certification process.
First Contact Health stated that they held robust documentary evidence for the claims in the ad. They provided copies of: eight scientific studies (including three randomised, controlled clinical trials); two meta-analyses; three review papers; a cost-effectiveness analysis; a consensus paper by the European Society for Sports Traumatology, Knee Surgery and Arthroscopy (ESSKA); and seven pieces of marketing material from the manufacturer of the product used in the advertised treatment that they said substantiated the claims in the ad.
First Contact Health also provided additional comments for some of the evidence submitted; namely, one of the meta-analyses, one of the randomised controlled clinical trials, and one of the dossiers summarising research. In relation to the meta-analysis, they said that the paper analysed randomised controlled studies and was the highest level of evidence for the efficacy of the treatment for knee osteoarthritis. They further considered that the randomised controlled clinical trial demonstrated that PRP could provide clinically significant functional improvement for a least one year in patients with mild to moderate osteoarthritis of the knee. They also stated that the dossier summarising research showed significant positive effects, such as decreased pain and improved functionality, on different types of tendinopathies but was particularly effective in insertional tendinopathies.
Assessment
Upheld
The ASA acknowledged that the products used in the advertised treatment had been CE-marked as class IIa, IIb and III medical devices. CE certification in itself did not constitute evidence for medical efficacy claims; advertisers needed to ensure that they held adequate evidence for such claims. As such, we understood that the MHRA had not approved the claims featured in the ad.
The ad featured the claims “A new and alternative solution to repair damaged tissue, ligaments and arthritic joints” and “We can use PRP to treat: Osteoarthritis, tendon problems (such as tennis elbow and Achilles tendonitis), torn ligaments and muscles […] For arthritic joints, Hyaluronic Acid (HA) is added to the PRP, which is a natural joint lubricant”. We considered that consumers would understand those claims to mean that PRP and HA were a type of new and breakthrough treatment which could provide a permanent solution to those who suffered from osteoarthritis, tendon problems, and torn ligaments and muscles. We considered that impression was reinforced by the claim that PRP could “trigger cell reproduction and stimulate regeneration of damaged tissues” and that its injection into damaged areas would “help with the healing process”. We therefore expected the advertiser to hold evidence, in the form of randomised clinical trials, to demonstrate that was the case.
Seven marketing materials produced by the manufacturer of the medical device used in the treatment and 15 papers were provided in full which referred to tendon problems or knee osteoarthritis. We did not receive any evidence to substantiate torn ligaments or muscles.
We first assessed the evidence related to tendon problems. The submissions consisted of four marketing materials which summarised research on the effect of PRP as a treatment. We noted that the dossiers supplied referenced the effect of PRP and HA injections on the swelling and inflammation of tendons across a number of conditions; specifically, chronic tendinopathies, non-insertional tendinopathies, gluteus tendon, shoulder supraspinatus, foot plantar fascia, Achilles and patellar tendinopathies, elbow tendinopathies, rotator cuff tears or tendinopathies, epicondylitis, and tendon tears. However, only research evaluating the treatment’s effect on Achilles and patellar tendinopathies and tendinosis was referenced in the marketing materials. Furthermore, we were not provided with full copies of the trials referenced in the research, so it was not possible to analyse the results. And, while it appeared that those who had received the treatment showed an improvement after 12 months, we did not consider that this demonstrated that the treatment was a permanent solution to all tendon problems. In the absence of the full trials, we concluded that the claims that PRP could treat tendon problems had not been substantiated.
The remaining evidence provided by First Contact Health was in relation to osteoarthritis, particularly knee osteoarthritis. We understood that National Institute for Health and Care Excellence (NICE) guidelines stated that evidence for the efficacy of PRP injections in treating osteoarthritis was limited in quality. Furthermore, NICE guidelines did not recommend using HA injections in patients for osteoarthritis.
Several of the studies supplied related to knee osteoarthritis but were not relevant to the claims in the ad. The cost-effectiveness analysis studied the cost-effectiveness of PRP injections in comparison to HA injections in patients with knee osteoarthritis. We noted that the cost-effectiveness of either PRP or HA injections did not feature in the ad, and consequently, considered that analysis was not relevant to the claims made in the ad. We also received two articles summarising the mechanics of PRP treatment. Whilst we acknowledged that these studies provided useful support for the concept underpinning the treatment, we considered that they did not demonstrate the efficacy of the treatment.
Furthermore, three of the papers assessed the use of only HA in relation to knee osteoarthritis. The first was a meta-analysis focused on determining the effectiveness of three weekly injections of HA compared to five weekly injections of HA in terms of pain relief in knee osteoarthritis patients. The second was a randomised, double-blind, placebo-controlled trial that assessed the efficacy of a single injection of HA in patients with knee osteoarthritis. The third was a review article which investigated the safety and efficacy of HA in osteoarthritis. Because the evidence assessed the efficacy of treating osteoarthritis with HA only, and the ad promoted a preparation of PRP and HA to treat osteoarthritis, we could not take these studies into account.
Four of the papers provided in relation to knee osteoarthritis assessed PRP only and included the consensus paper by ESSKA, two uncontrolled studies and one of the randomised clinical trials. Whilst we acknowledged ESSKA’s comments on the matter, we considered that they did not constitute documentary evidence and as such could not take them under consideration. The two uncontrolled studies assessed the effect of PRP injections in patients with knee osteoarthritis. Both trials had very small sample sizes of 30 and 24 respectively which we considered were too small for results to be extrapolated to the wider population and therefore were insufficient to evidence the claims in the ad. The randomised clinical trial was a double-blind placebo-controlled trial which compared the effect of PRP injections with HA injections in 53 patients with knee osteoarthritis. We noted the small sample size and did not consider a trial conducted on 53 patients sufficient to demonstrate the effects of the treatment. Whilst we acknowledged the presence of a control group, we considered the positive placebo effect experienced by that group indicated that results which relied on self-reported improvement scores alone might be subject to factors other than the treatment protocol. In any case, we understood the ad stated that it was necessary to undergo a treatment of both PRP and HA for osteoarthritis. We therefore considered those studies which assessed the effect of PRP only on osteoarthritis were not relevant to the claims in the ad.
We then assessed the studies which assessed both PRP and HA on the treatment of knee osteoarthritis, which included three of the marketing materials and five of the papers provided; specifically, two pilot studies, an uncontrolled trial, a randomised clinical trial, and a meta-analysis.
The marketing materials summarised research involving the effect of PRP and HA injections on knee osteoarthritis. Many of the studies referenced were not provided in full, meaning we were unable to assess them, and as such could not take evidence into account related to those studies. In cases where full studies had been provided alongside the marketing materials, the summaries did not prove sufficient to substantiate the claims.The first pilot study investigated the effects of PRP and HA injections in 77 patients with knee osteoarthritis. We understood that the results were based on self-reported pain and mobility scores which we considered to be a subjective measure that was susceptible to bias. Moreover, the study did not have a control group and therefore it was uncertain whether any improvement in mobility or pain felt by the patients was due to the treatment being studied, rather than to other factors. We also noted that several of the authors received consulting fees from the manufacturer of the treatment protocol used in the study. For those reasons, we considered that pilot study was inadequate to support the claims in the ad.
The second pilot study analysed the effects of PRP and HA injections on six patients with knee osteoarthritis by using MRI scans. Whilst we acknowledged that the study relied on results indicated by MRI scans rather than self-reported pain and mobility scores, we noted that the study had a very small sample size. Furthermore, the study concluded that “the small number of patients did not allow for a relevant statistical study”, and accordingly we considered that a trial conducted on six patients was insufficient to demonstrate the efficacy of the treatment.
The uncontrolled trial studied the effect of PRP and HA injections in those with knee osteoarthritis. We acknowledged that the trial appeared to demonstrate that PRP and HA injections had a positive effect on the condition and that results were measured using MRI and ultrasound scans, as well as self-reported pain scores. However, there was no control group and evidence regarding the statistical significance of results was not provided in the trial. Furthermore, the follow-up evaluation was carried out after only 12 months. As such, we considered that the study did not have the longevity of results to support the claims in the ad that PRP and HA treatment provided a long lasting effect on relieving arthritis.
The randomised clinical trial was a double-blind controlled trial which compared the effect of PRP and HA injections against two different types of HA injections in 53 patients with knee osteoarthritis. The study demonstrated a statistically significant improvement in all measured scores of those who underwent the PRP and HA treatment, in comparison to those who received HA only. However, only 19 patients received the PRP and HA treatment, which we did not consider sufficient to demonstrate the effects of the treatment. Furthermore, the control group also received treatment in the form of HA injections. Whilst we considered that was a reasonable comparison, this meant all patient groups received a form of treatment. Because of that, there was not a true sham control group, meaning that we could not assess the results in line with how the pain of individuals who were not receiving treatment would typically change. Finally, the results were based on self-reported pain and mobility scores over a 12-month period, and we considered results based on self-reported measures over a period of 12 months were not capable of substantiating claims of tissue healing and regeneration or claims that indicated a permanent cure to osteoarthritis.
The meta-analysis evaluated the efficacy of PRP combined with HA injections versus HA injections alone for the management of knee osteoarthritis. The analysis was based on four studies - three randomised clinical trials and one observational cross-sectional study, with a total sample size of 377. We acknowledged that the meta-analysis indicated that PRP and HA injections resulted in greater pain relief and improved function when compared with hyaluronic acid alone. Again, we noted that the results in all studies used were based on self-reported pain and mobility scores. Consequently, we considered that the scores were subjective and that various factors could have influenced their improvement. Furthermore, we understood that the frequency of injections, formulations and concentrations used were not standardised among the studies selected for analysis. Because the treatment received by patients included in the meta-analysis was not consistent, we considered that study could not sufficiently determine the efficacy of PRP and HA injections. Moreover, we had not been supplied with information regarding the preparation or concentration of PRP administered to patients by First Contact Health. As such, we considered the PRP treatments in the studies did not necessarily reflect the treatment advertised by First Contact Health. In addition, whilst we acknowledged that the sample size was considerable, we noted that a number of those originated from an observational cross-sectional study, rather than a randomised controlled clinical trial. As such, we considered that the results may have been subject to bias. For those reasons, we considered that the meta-analysis study was not sufficient to substantiate the efficacy claims.
Accordingly, we considered that the evidence was insufficient to support that PRP and HA could treat knee osteoarthritis. Notwithstanding the above, we noted that the ad referred to osteoarthritis, rather than knee osteoarthritis specifically. We considered that the knee joint was just one area that osteoarthritis could affect, and we had not seen evidence of the efficacy of PRP and HA in treating osteoarthritis in other areas of the body.
We had not been provided with evidence using PRP to treat damaged tissue, ligaments or muscles. The research we had received related to tendon problems and osteoarthritis, which was not adequate to substantiate the ad. We therefore concluded that the claims made in relation to those conditions had not been substantiated and were misleading.
The ad breached CAP (Edition 12) rules 3.1 (Misleading advertising), 3.7 (Substantiation) and 12.1 (Medicines, medical devices, health-related products and beauty products).
Action
The ad must not appear again in its current form. We told First Contact Health not to make claims that their PRP and HA injections could treat arthritis, tendon problems, torn ligaments and muscles problems in the absence of adequate substantiation.
