Ad description

Claims in a TV ad and regional press ad for a device to help relieve back pain:

a. The TV ad stated, "Are you suffering from lower back pain? Do you wake up with nagging aches and stiffness? Now you can help relieve your pain with Kyrobak. The drug free in-home treatment for back pain. With Kyrobak it takes just ten minutes of soothing treatment from the comfort of your own bed, couch or floor ... If you can lie down to rest you can relieve yourself of back pain with Kyrobak. It's that easy ...The secret is Kyrobak's proprietary technology; a fusion of oscillation therapy and continuous passive motion ...".

b. The regional press ad stated, "Introducing Kyrobak, the only home-use device using professional Continuous Passive Motion (CPM) technology, recommended by doctors worldwide, that's clinically proven to bring you ... LASTING RELIEF from BACK PAIN ... Kyrobak is clinically proven to treat lower back pain and provide lasting relief ... And in a recent clinical study, Kyrobak was shown to continue to provide pain relief even 3 weeks after usage was stopped! ... Just 10 relaxing minutes a day is all it takes for Kyrobak to deliver lasting relief for your lower back pain ... Kyrobak is clinically proven to be effective in providing relief from lower back pain, whilst treating one of its main causes; lack of movement in the lower back area ... you should experience fewer bouts of back pain in the future".

Issue

A viewer and a reader challenged whether the efficacy claims in the TV ad (a) and press ad (b) were misleading and could be substantiated.

Response

Photo Therapeutics Ltd provided details of two clinical trials. The first reported a treatment group of 36 patients with mild to moderate chronic lower back pain, who were directed to use the device between one and three times per day for three weeks. Half the participants were randomly assigned to a ‘waiting list control’ group to wait three weeks for the device, with the reported intent to be to control for any placebo effect caused by an expectation of receiving treatment. After the treatment period each group had a further three-week follow-up period during which the device was returned. The primary outcome measure was a change in the numerical pain rating scale (NPRS) reported by participants, and the secondary, being a change in the Oswestry Disability Index (ODI). The study reported that no beneficial effect was found during the waiting list period, and so the results from both groups were analysed together. The study reported that for the 28 participants who completed the three-week treatment period, the mean reduction from baseline NPRS values was 1.3 initially, and for the 24 who completed the three-week follow-up, the mean reduction from baseline was 1.10, both of which were stated to be statistically significant. A decrease in ODI scores was also reported, but the trial noted that these were not clinically significant.

The second trial comprised a participant group of 16 subjects and was conducted over three weeks with a primary outcome measure of NPRS reduction and secondary measures of changes in ODI, patient satisfaction, diary-based daily pain assessment, digital posturography, heart rate variability and static electromyography (EMG). The study reported that nine subjects who had complied with the test protocol had a mean 2.87 decrease from baseline NPRS values at the end of treatment and a mean 2.61 decrease a week after treatment ended, both of which were stated to be statistically significant. It was also noted that 12 subjects who complied with the protocol had a statistically significant average reduction from baseline ODI scores of 18.83 (50.7%) at the end of treatment, and 11 compliant subjects had a statistically significant average reduction of 20.55 (55.3%) from baseline at a one-week follow-up. The study reported that 83.3% of the subjects post-treatment, and 81.8% at follow up, achieved the clinically significant reduction of at least 10 ODI points from baseline. The other secondary outcome measures were reported positively, with varying degrees of statistical significance or scale of change.

Photo Therapeutics also provided details of their patent applications, which outlined the mode of operation of the device, and written material providing further details about the trials.

With regard to ad (a), Clearcast stated that they had submitted the original script and supporting data to their consultant, who was broadly in agreement with the claims, and the script was subsequently amended in accordance with his advice. They considered that as long as the ad made reference to repeated and regular use over a three-week period then the viewer's experience was likely to be representative of the efficacy recorded by the two studies. They stated that the consultant agreed that the supporting evidence showed that the product could relieve pain. Clearcast also stated that the product was not presented as a medical treatment and claimed only to ‘help relieve’ the symptoms of lower back pain. They stated that their consultant was satisfied that the device was generally fit for purpose and that there was no suggestion that it was suitable for someone with a serious or chronic spinal condition. They stated that the product was a CE marked medical device to treat non-specific lower back pain using continuous passive motion and oscillation therapy and as such was considered low risk. Although they felt the supporting data could be more robust they asserted that it was sufficient to support a low level claim such as temporary relief from pain.

Assessment

Upheld

The ASA took advice from the Medicines and Healthcare Products Regulatory Agency and an independent expert. We noted that the ads referred to providing relief for back pain, which we considered to be a treatment claim for a health condition, and concluded that they therefore made medical claims for the product. We noted that the clinical trials provided by Photo Therapeutics stated statistically significant results for improvement in the participants reported levels of pain. However, we also noted that the second trial did not contain a control group against which to compare participant outcomes and considered that the methodology of this trial was insufficiently robust to support the claims in the ad. Moreover, for the second trial no justification was given for the small sample size, non-compliant participants were not included in the statistical analysis and several outcomes were measured, factors which we understood were likely to produce a result more favourable to the treatment.

The first study did not use a placebo control or any form of blinding but used a Waiting List Control methodology, which we understood to be appropriate for trials of this type of device, as patients would be likely to detect which group they were in if blinding was attempted. We noted that the sample size for this trial had been calculated from the parameters of the primary outcome measure and that, although a more conservative calculation (and therefore a larger sample) would have been more robust, the sample group was above the minimum required to achieve a statistically significant result. However, the trial was intended to substantiate a medical claim relating to the relief of low back pain, for which a robust body of evidence would be required. While the sample size in the trial was sufficient to secure a statistically significant outcome, we considered that the number of participants was nonetheless insufficiently large for the first trial, either in and of itself or in conjunction with the second trial, to support the claim.

This issue notwithstanding, the statistical analysis from the first trial did not include data from those participants who had dropped out of the studies, an approach that we understood favoured the treatment being investigated. We understood that Photo Therapeutics believed that this reflected the real world situation where people who had paid for a treatment would make an effort to fulfil it before abandoning their attempts. However, we also understood that the inclusion of these patients’ data in the analysis would be likely to reduce the mean effect of the treatment (since the effect of the treatment on these participants was zero or negative) and thus reduce the robustness of the assertion that pain levels were consistently reduced. Photo Therapeutics provided an additional analysis of the initial treatment stage data, which they said included the baseline data from the patients who had withdrawn before completion of the trial. This analysis reported a smaller, but still statistically significant effect. However, although the withdrawn patients were now represented by their baseline data (thereby being reported as a ‘zero effect’), three of the participants had reported an increase in pain leading to their withdrawal from the trial. The use of baseline values for these specific participants meant that the outcome of the data analysis did not take into account the impact of increased pain on the statistical average. We therefore considered that, although the design of the trial was not problematic in itself, the analysis of the data was insufficient to support the conclusions drawn and the claims made in the ad.

Furthermore, we noted that while the claims in the ads related to using the device for 10 minutes per day (which we understood was a single cycle) participants in the first trial were encouraged to use the device up to three times per day and in the second were reported to have used it an average of 2.13 times per day. Although we noted that on-screen text in ad (a) referred to using the device twice per day, we considered that the primary and most prominent claim related only to 10 minutes of use. We also noted that ad (b) only featured claims relating to 10 minutes of daily use. Therefore, the supporting evidence needed to substantiate this. As such, even had the statistical analysis of the first study and the methodology of the second been robust, the method of use tested did not match the claims made for the product in the ads. We therefore concluded that they had not substantiated the claims made in the ads.

Ad (a) breached BCAP Code rules  3.1 3.1 Advertisements must not materially mislead or be likely to do so.  (Misleading advertising),  3.9 3.9 Broadcasters must hold documentary evidence to prove claims that the audience is 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) and  11.2 11.2 If they are necessary for the assessment of claims, broadcasters must, before the advertisement is broadcast, obtain generally accepted scientific evidence and independent expert advice.  (Medicines, medical devices, treatments and health).

Ad (b) breached CAP Code (Edition 12) rules  3.1 3.1 Advertisements must not materially mislead or be likely to do so.  (Misleading advertising),  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) and  12.1 12.1 Objective claims must be backed by evidence, if relevant consisting of trials conducted on people. Substantiation will be assessed on the basis of the available scientific knowledge.
Medicinal or medical claims and indications may be made for a medicinal product that is licensed by the MHRA, VMD or under the auspices of the EMA, or for a CE-marked medical device. A medicinal claim is a claim that a product or its constituent(s) can be used with a view to making a medical diagnosis or can treat or prevent disease, including an injury, ailment or adverse condition, whether of body or mind, in human beings.
Secondary medicinal claims made for cosmetic products as defined in the appropriate European legislation must be backed by evidence. These are limited to any preventative action of the product and may not include claims to treat disease.
 (Medicines, medical devices, health-related products and beauty products).

Action

The ad must not appear again in its current form. We told Photo Therapeutics Ltd not to repeat the efficacy claims made in the ads and to ensure that they held robust substantiation for claims in future advertising.

BCAP Code

11.2     3.1     3.9    

CAP Code (Edition 12)

12.1     3.1     3.7    


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