Background
Summary of Council decision:
Two issues were investigated, both of which were Not upheld.
Ad description
Two TV ads for Nurofen products:
a. An ad for Nurofen Express seen on 10 March 2018 showed a man on a pedalo being overtaken by a speed boat with a voice-over which stated, “Sometimes the choice is obvious”. The next frame showed two drawers being opened side by side, with the left one containing a box of generic paracetamol and the right containing a box of Nurofen Express liquid capsules. The voice-over stated, “When it comes to headaches choose Nurofen Express. Clinically shown to provide faster, more effective headache relief than standard paracetamol.” The phrase “Clinically shown to provide faster, more effective headache relief than standard paracetamol*” also appeared on-screen. Small text appeared at the bottom of the screen for the duration of the ad which read “Blocks enzymes that cause pain. *400mg ibuprofen vs 1000mg paracetamol. For pain relief. Contains ibuprofen. Always read the label”.
b. An ad for Nurofen for Children seen in June 2018 showed a toddler being carried by an adult and then lying down in bed asleep. The voice-over said, "When Sam came down with a burning fever, I gave him Nurofen for Children which lasts longer than paracetamol ... Nurofen for Children: longer lasting fever relief than paracetamol".
Issue
The ASA received two complaints.
1. One complainant challenged whether the comparison “Choose Nurofen Express. Clinically shown to provide faster, more effective headache relief than standard paracetamol” in ad (a) was misleading and could be substantiated.
2. One complainant challenged whether the claim that Nurofen for Children lasted longer than paracetamol in ad (b) was misleading and could be substantiated.
Response
1. RB UK Commercial Ltd (RB) said that the ad featured a superiority claim which was about the Nurofen Express ibuprofen liquid capsules versus standard paracetamol as treatment for headaches. They had undertaken a review of evidence from a systematic literature search of direct comparisons of the two products and found one relevant randomised controlled trial (RCT). They provided us with a copy of the trial and said that the research produced statistically significant results which showed that 400 mg of liquid ibuprofen was faster and more effective than 1000 mg of standard paracetamol.
Clearcast said that they had assessed the evidence used to support the claim and worked closely with the advertiser to ensure that it could be substantiated. RB had provided them with a study that showed the comparison between ibuprofen liquigel and paracetamol. The study had been reviewed by their medical consultant who said that it showed that ibuprofen liquigel demonstrated significantly superior overall analgesic efficacy compared with paracetamol for the relief of episodic tension type headaches. The consultant provided advice on the on-screen text which made the basis of the comparison clear.
2. RB said that the intention of the ad about Nurofen for Children was to communicate to consumers that ibuprofen was effective at reducing fever in children for up to eight hours. They explained that the fever relief referenced in the ad was an example of how the product may be used in line with its licensed indication. They also said that the claim was part of a substantiated efficacy comparison between ibuprofen and paracetamol. To substantiate the claim they provided two RCTs, one placebo controlled trial, an abstract of an RCT and a review as substantiation.
Clearcast said that they had received two papers as substantiation for the claims in the ad, which had been reviewed by a medical consultant. The consultant said that the first paper contained a key comparison with paracetamol and showed that ibuprofen provided longer and significantly greater reduction in temperature. They said that the study was conducted over eight hours and they were satisfied that the study substantiated the claim. Clearcast provided the two RCTs, one of which had also been provided by RB.
Assessment
1. Not upheld
The ASA considered that consumers would understand the claim “Choose Nurofen Express. Clinically shown to provide faster, more effective headache relief than standard paracetamol” to mean that Nurofen Express liquid capsules provided quicker and more meaningful relief from headaches than paracetamol tablets.
RB provided a copy of a peer-reviewed clinical trial which was randomised, double blinded and a parallel group study. It compared paracetamol, ibuprofen and a placebo on 154 participants with a history of episodic, moderately severe tension type headaches. Patients received a single dose of either 400 mg of ibuprofen in liquid capsule form or 1000 mg of paracetamol, or a placebo and were asked to record the moment they first felt perceptible relief from their headache and if relevant, when they first felt meaningful relief. Potential subjects were excluded for reasons such as having a history of migraines and being habituated to analgesics. Upon arriving at the trial clinic, participants gave their current headache pain a score on a four-point categorical pain rating scale which was then confirmed with a visual analogue pain scale score. Those who rated their headache as being at least moderately severe were eligible to participate in the trial. Participants were split into groups by gender and randomised with a computer generated code and assigned to one of the three treatment groups. The participants were given two stopwatches with their faces covered. They were asked to stop the first stopwatch when they first noticed that they had perceptible relief from the headache. They were then asked if the relief was meaningful. If they answered no, they were asked to stop the second stopwatch when they felt meaningful relief. The pain intensity and relief were measured using a four- and five-point scale two and three hours after dosing. All 154 subjects who were randomised to a treatment group completed the study and were included in the analysis which assessed whether the results were statistically significant.
The study concluded that the ibuprofen liquid capsules were significantly faster in providing relief for headaches than normal paracetamol. The mean time to first perceptible relief for ibuprofen was 39 minutes, compared with 47 minutes for paracetamol. The mean time to first meaningful relief for ibuprofen was 39 minutes compared with 53 minutes for paracetamol.
We were satisfied that the methodology used in the RCT was robust and that it adequately substantiated the claim “Choose Nurofen Express. Clinically shown to provide faster, more effective headache relief than standard paracetamol” and therefore concluded that the claim was not misleading.
On this point, we investigated the ad under 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 3.12 3.12 Advertisements must not mislead by exaggerating the capability or performance of a product or service. (Exaggeration), but did not find it in breach.
2. Not upheld
The ad showed a child being carried to bed and then when asleep, with the Nurofen logo on his chest. The voice-over said, “When Sam came down with a burning fever I gave him Nurofen for Children, which lasts longer than paracetamol, up to 8 hours. So he could get a good night’s sleep.” We considered that consumers would understand the claims “Nurofen for Children which lasts longer than paracetamol” and “Nurofen for Children: longer lasting fever relief than paracetamol” to mean that if they gave their child Nurofen for Children it would provide longer and a greater reduction in body temperature than a paracetamol-based product.
RB provided three clinical trials which compared the effect of ibuprofen and paracetamol in children in an age range of between 11 months and 12 years. All three studies used broadly similar methodologies with slight differences in trial design. One study from 1992, which had 39 participants, was randomised, open label (where the participants and researchers knew what medicine was being administered) and used a parallel design (where the groups only received one type of medicine each). The study had two groups and gave patients either a single dose of liquid ibuprofen at 6 mg/kg or 5-10 mg/kg of liquid paracetamol.
A second trial from 1992, which had 37 participants, was a placebo controlled, double-blind designed trial. The trial had four groups: placebo; 10 mg/kg of paracetamol; 7.5 mg/kg; and 10 mg/kg of ibuprofen. The third study from 1989, which had 127 participants, was randomised and double-blinded, with a parallel group using a triple dummy design. There were four groups: placebo; 5 mg/kg of liquid ibuprofen; 10 mg/kg of liquid ibuprofen; and 10 mg/kg of liquid paracetamol.
All the trials had a minimum temperature required for entry into the trial and excluded participants who had taken antipyretics shortly before they entered the trial. All three trials measured the patient’s temperature either once or twice before they were given the medicine and then again afterwards at regular intervals of either 20 minutes, 30 minutes, or an hour until 8 hours after the dose. In all of the trials each time a patient’s temperature was taken, it was taken twice and the median recorded. We were satisfied that each trial had treated the groups equally and that all the patients were accounted for at the end of the study. All of the studies undertook statistical analysis to assess the significance of the results.
The first study from 1992 was not blinded, whereas the other two studies were both double blinded. We considered that the first study’s methodology was not as robust, because without the design being blinded, the results were more susceptible to bias from those conducting the trial. We were satisfied with the other aspects of the trial design such as the double temperature measurement and recording the median to be used in the analysis. We were satisfied that the methodology of the other trials was robust.
The trials all concluded that ibuprofen provided longer and greater relief from fever at the later time points in the trials. The results of the first study from 1992 showed that the average maximum temperature decrease was greater in the group who had received ibuprofen and that it was greater at later time points in the study. The study concluded that ibuprofen effectively reduced the temperature of children with a fever and that the reduction lasted longer than in the paracetamol group. The second study from 1992 showed that the ibuprofen provided a greater reduction in temperature and worked for a longer time than paracetamol when the two drugs were administered in approximately equal doses. It further concluded that there was no significant difference between doses of 10 mg/kg and 7.5 mg/kg of ibuprofen. The third study from 1989 showed that there was a greater and longer decrease in temperature in both ibuprofen groups, with a statistically significant reduction seen in the group who had received a 10 mg/kg dose of ibuprofen. We understood that due to the nature of fever in children, even a small reduction in temperature was clinically significant. Overall, we were satisfied that all the trials showed that liquid ibuprofen provided longer and greater relief from fever in children and it had been shown that this could last up to 8 hours.
RB also provided an abstract which summarised a RCT that compared the effect of a single dose of ibuprofen suspension with paracetamol elixir in children with a fever. The report abstract concluded that there were statistically significant differences in clinical responses between 4 and 6 hours, with 100% of patients in the ibuprofen group reporting that they felt better compared with only 83.3% of the paracetamol group. However, we were not provided with a full copy of the study and did not consider the abstract on its own adequate to act as substantiation for the claim.
RB further provided a systematic review of studies in children which compared the effect of ibuprofen with paracetamol. The literature review searched for papers which included randomisation of study participants, adequate control interventions, publication in a peer-reviewed journal, were in vivo, and only involved children between two and 12 years of age. After the inclusion criteria were applied, 22 articles were reviewed. The review stated that the doses varied per study but that better results were seen when the children received 10 mg/kg ibuprofen compared with 5 mg/kg of ibuprofen or paracetamol. The review commented that the measurements in each trial were taken at different time periods, but that most trials went to 6 hours post treatment with some going up to 8 hours. The study concluded that when comparing 10 mg/kg of paracetamol with ibuprofen, paracetamol had a greater initial reduction in temperature, but that ibuprofen was more effective at 4 hours and that the effect lasted longer. It further explained that as ibuprofen exhibited anti-inflammatory properties and superior analgesic potency, that it might provide additional therapeutic benefits in children with fever.
Clearcast provided an additional RCT which looked at the efficacy of ibuprofen in paediatric patients with a fever. We considered that the trial demonstrated the overall efficacy of ibuprofen as a treatment for children who had a fever, but that it was not relevant to the claims that ibuprofen’s effects lasted longer than paracetamol.
For the reasons set out above, we concluded that the evidence, taken together, adequately substantiated the claims Nurofen for children which lasts longer than paracetamol” and “Nurofen for children: longer lasting fever relief than paracetamol", and the claims were therefore not misleading.
On this point, we investigated the ad under 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 3.12 3.12 Advertisements must not mislead by exaggerating the capability or performance of a product or service. (Exaggeration), but did not find it in breach.
Action
No further action required.
