Claims on www.hollandandbarrett.com stated, "Patch It - Circulation Patch It. Circulation Patch-It is clinically tested for tired, aching, heavy feet & legs. Contains Menthol, well known to be beneficial to healthy circulation, which is the basis for maintaining optimum health and can support recovery from injury & strenuous exercise. The Patch-It series has been developed from the original & internationally best-selling foot patch, using a blend of natural ingredients including Mandarin wood vinegar to simulate the actions of reflexology."
The complainant challenged whether the efficacy claims were misleading and could be substantiated.
Holland & Barrett Retail Ltd submitted a comment provided by the supplier of the product. The comment said that infra-red images had been taken using medical thermography, including by a Harley Street specialist in London, and that the images had shown changes in heat signature in other parts of the body four hours after the patch was applied to the foot. They said that the product had been clinically tested for efficacy and provided a copy of the published study in which the product was also tested.
The ASA acknowledged the comment Holland & Barrett provided from the supplier. We also noted that the clinical study concluded that the product alleviated swelling and "other associated symptoms" in the feet and legs. However, we noted that Holland & Barrett did not provide any further detail on the thermography test and we had not seen any documentary evidence to substantiate the observations made by the supplier. We also noted that the clinical study concluded that "future studies with larger sample sizes, which include patients with predefined comorbidities will improve the extent to which these results could be extrapolated to the general population" and stated that the "beneficial effect" of Patch It had yet "to be studied".
We noted that the objective of the trial was to "document its effect in comparison with a placebo patch". We noted that the method for comparing the two products involved participants using one patch for four weeks and the other patch for a further four weeks. We considered that there might be some overlap in the effects of the patches, noting that the study stated "it was expected that by day 56, the effect of the first patch would have worn off and the effect of the second patch would plateau". We also noted that the study stated that how the product brought on its effects was "yet to be established" and that the trial did not seek to understand how Patch it worked.
We noted that the report cited a number of other limitations to the evidence. For example, it said that the product was "believed to act partly via reflexology", which was described as a "science that currently lacks clear evidence for its claimed effects". It also referred to several problems with the methodology, including the lack of a "washout period", a period before the trial in which participants would not receive treatment. It also mentioned that the "interrater reliability" of the method used for measuring ankle joints, a process used to evaluate the efficacy of the product, had not yet been established. The study also noted that it had not shown a reduction in individual patient complaints about pain, and instead, focused on "one or more complaints that were important to each individual that participated in the trial". We noted participants were not permitted to take medications for the symptoms being studied, but were able to take other medications. We considered that, as the study only focused on selected pain complaints, participants might have taken medication for similar or related symptoms.
We noted that part of the evaluation process included asking whether the participant would use the product again. We considered that this was a subjective method, relying upon individual opinion, rather than scientific evidence. We also noted that participants were asked to use a psychometric response scale (the visual analogue scale) to measure the amount of pain or discomfort they were experiencing. We considered that the method failed to take into account the potentially intermittent nature of pain and therefore might not have given an accurate depiction of the participant's experience. The study also made reference to the fact that all participants were patients who sought medical care for problems such as swelling, aching and discomfort. We considered that the benefit to those seeking medical care might be different to the benefit to those experiencing discomfort, but not seeking medical attention. We considered that the ad did not make it sufficiently clear that the benefits might only be relevant to individuals with more advanced pain. We considered the study was not sufficient to substantiate the claims made in the ad. Because of that, we concluded that the ad was misleading.
The ad breach CAP Code (Edition 12) rules 3.1 3.1 Marketing communications must not materially mislead or be likely to do so. (Misleading advertising) and 3.7 3.7 Before distributing or submitting a marketing communication for publication, marketers must hold documentary evidence to prove claims that consumers are likely to regard as objective and that are capable of objective substantiation. The ASA may regard claims as misleading in the absence of adequate substantiation. (Substantiation).
The ad must not appear in its current form. We told Holland & Barrett not to make efficacy claims unless they held documentary evidence to substantiate them.