Ad description
A national press ad for Silicolgel, seen on 17 March. It included an image of a torso with a stomach and digestive tract superimposed on it and text that stated “Silicolgel. The stomach protector. Colloidal silicic acid for gastrointestinal disorders. Fast effective treatment for: IBS symptoms, heartburn & reflux, diarrhoea, stomach ache, flatulence, nausea … Silicolgel taken orally, works by coating the stomach and intestine with a protective layer. The gel binds with irritants and toxins which are rendered harmless to pass naturally out of the body. Also binds with gases. A single tablespoon of silicolgel taken three times a day is shown to normalise the stomach and bowel quickly and without side effects”.
Issue
The complainant challenged whether the claims that Silicolgel could treat the conditions listed were misleading and could be substantiated.
Investigated under CAP Code (Edition 12) rules 3.1 (Misleading advertising), 3.7 (Substantiation) and12.1 (Medicines, medical devices, health-related products and beauty products)
Response
FW Medical Ltd provided a certificate from the relevant Notified Body in Germany showing that Re-Silica Magen-Darm Gel (sold as Silicolgel in the UK) met the requirements of Annex V of Council Directive 93/42/EEC concerning medical devices and was classed as a IIa medical device.
They stated that in 2015, the MHRA had advised them to remove claims that the device could treat Irritable Bowel Syndrome (IBS), as the documentation from the manufacturer only referred to the treatment of IBS symptoms. They had subsequently made changes to their marketing materials.
FW Medical Ltd provided the manufacturer’s Clinical Evaluation Report (CER), which summarised the results of several studies on Silicolgel as well as three other orally-administered products containing silicium dioxide and/or silicic acid and intended for the treatment of gastrointestinal symptoms. They provided full copies of two of these studies. In addition, they supplied a table of statements taken from their post-marketing customer testimonial records attesting to the effectiveness and efficiency of Silicolgel.
They said that this dossier of evidence supported the claims that the product could treat the symptoms listed in the ad.
Assessment
Upheld
The ASA understood that the certificate from the German Notified Body was sufficient to demonstrate that Silicolgel was a Class IIa medical device which conformed with the Medical Devices Directive 93/42/EEC. However, we noted that a CE certification did not constitute evidence for the purposes of rule
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.
of the CAP Code, and advertisers were required to hold documentary evidence to support efficacy claims.
We considered that consumers would understand the claim “Fast effective treatment for: IBS symptoms, heartburn & reflux, diarrhoea, stomach ache, flatulence, nausea” to mean that Silicolgel was proven to treat each of these individual problems. We acknowledged that the advertiser had amended the claim to refer to “IBS symptoms” rather than the condition of IBS. We also understood that all the additional listed symptoms, with the exception of heartburn and reflux, were common symptoms of IBS. However, we understood that there were additional common and associated symptoms of the condition which were not referred to in the ad (for example, constipation, bladder problems and lethargy) and we considered that consumers would expect the efficacy claim about the treatment of “IBS symptoms” to refer to all of these.
We noted that the CER referenced studies on several products that contained some of the ingredients in Silicolgel, but in different concentrations. We did not consider that the results of testing these products would be sufficient to demonstrate the efficacy of Silicolgel. Therefore, we confined our assessment to two clinical studies – one on Silicolgel itself and one on Silicea Gastrointestinal Gel, a CE-marked medical device containing a concentration of 3.5 mg silicium dioxide per 100 ml silicic acid gel, identical to that found in Silicolgel. FW Medical Ltd provided full copies of both trials.
We noted that the study on Silicolgel was produced for the manufacturer and was unpublished. We noted that it was a randomised, double-blind, placebo-controlled, multi-crossover trial, conducted among 30 patients with non-ulcer dyspepsia. The participants received either Silicolgel or a placebo for one week, then crossed over to the opposite treatment and were treated for another week. This procedure was repeated twice, so each patient was treated for six consecutive one-week periods, changing from one treatment to the other every week. The study indicated that there was a statistically significant reduction in the degree of heartburn, reflux, diarrhoea, abdominal pain, discomfort and nausea experienced by patients over the course of the study, as well as a reduction in the frequency of heartburn and reflux. We understood that the difference for each symptom was based on the difference between the mean variables for all participants at the start and at the end of the trial.
We also noted that the efficacy of Silicolgel compared to the placebo was analysed using two types of efficacy index for each patient who completed the trial. These were obtained by calculating the mean of the differences between the recorded degree of all symptoms as well as the number of antacids taken in each Silicolgel period, and in the preceding and succeeding placebo periods. We noted that while there was tendency in favour of Silicolgel for both categories, the difference was not statistically significant. Furthermore, the efficacy index for the reported degree of symptoms was based on all symptoms combined, and did not express the differences in the degree of each symptom during the Silicolgel and placebo periods. As such, while we acknowledged that the results of the study suggested that Silicolgel could relieve gastrointestinal discomfort, we did not consider that the results of the study were sufficient to support the claims that the product could treat each of the individual symptoms listed.
We noted that the study on Silicea Gastrointestinal Gel (SGG) was a non-controlled pilot trial, conducted among 62 patients who were divided into overlapping subgroups based on their primary symptoms or disorders (for example, IBS symptoms, gastroesophageal reflux disease, or upper abdominal gas). The subjects scored the intensity, frequency and impact of their symptoms at three weeks and six weeks after beginning to use SGG. We noted that the study showed a statistically significant difference in the scores for both upper abdominal and lower abdominal symptoms during the course of the trial. Patients were classed as “responders” if the reduction in their scores was greater than 50%, with a total responder rate of 39%. The study also presented selected responder rates for different subgroups, some with reference to specific symptoms. We noted that the sample sizes for the subgroups were small, ranging from 2 to 34 participants. Furthermore, the authors of the study acknowledged that it was unclear to what extent the responses could be the result of the placebo effect. Given the lack of clear differentiation between the effects of the product on individual gastrointestinal symptoms, as well the lack of a control group, we did not consider that the results of this study were sufficient to support the claims.
Because we considered that the evidence provided was not sufficiently robust to support the claims, we concluded that they had not been substantiated and were misleading.
The ad breached CAP Code (Edition 12) rules
3.1
3.1
Marketing communications 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 claims must not appear again in their current form. We told FW Medical Ltd not to claim that Silicolgel could treat specific symptoms or conditions unless they held sufficient documentary evidence to support their claims.
