WALNUT CREEK, Calif., Jan. 15, 2016 /PRNewswire/ — Child screams from the pain of earache; exhausted parent ventures to drugstore in wee hours to find…nothing. “Eardrops don’t work,” says Dr. Scott Morehouse, founder of ClearPop, “because the Eustachian tube, where the pain occurs, is connected to the mouth, not the outer ear.”
The beleaguered parent now drags hollering kid to the doctor’s office, only to find the pediatrician reluctant to prescribe antibiotics. Since 2013, the American Academy of Pediatrics endorses a wait-and-see approach, seeking to let more earaches heal on their own without antibiotics.
In light of this, Morehouse developed a lollipop with a patented shape optimized to pull congestion out of the middle ear and into the mouth. ClearPop for Rapid Earache Relief has been shelved by Raley’s (CA, NV) select RiteAid locations, and is available at boutique drugstores and Amazon. Moms have flooded https://www.facebook.com/ClearPop with glowing testimonials for this simple drug-free solution that:
-doesn’t require an ER or doctor visit.
-can be given along with analgesics or antibiotics.
-is increasingly used by frequent flyers to deal with ear pain that afflicts children disproportionately during air travel.
-is naturally flavored.
-is a delicious treat to a kid.
Children diagnosed with Acute Otitis Media, or ear infection, consumed the xylitol and Vitamin C-based product in pediatric offices. After 20 minutes, 88.5% reported their ear pain dramatically reduced or vanished. The earache episode was totally resolved for 80%. Full study report at http://clearpop.com
EAR INFECTION AND ANTIBIOTICS
Ear infections are the Number One reason kids aged 5 and under receive oral antibiotics. Due to increasing concern about antibiotic overuse and its links to obesity, celiac disease, and Superbugs, the American Academy of Pediatrics now recommends against the use of antibiotics to treat routine ear infections in children over 2.
ClearPop for Rapid Earache Relief represents a simple, safe, pediatrician recommended, clinically effective and fun way to treat earaches. ClearPop is made by Try This First, Inc. a physician-funded “small pharma” organization aimed at reducing the estimated 30 million antibiotics prescriptions written to children yearly for ear infection. Founder and Chairman: Dr. Scott Morehouse, email@example.com
This release describes a medical device that is promoted as a safe first-line treatment for pediatric ear ache symptoms and an alternative to antibiotics. It combines xylitol (a sugar alternative) and Vitamin C which are delivered in a patented lollipop shape to draw congestion out of the middle ear. All parents can relate to the need for a treatment for earache symptoms but this release skirts major gaps in the evidence for this particular approach. It does not explain that there are no peer-reviewed scientific findings supporting this product. It does not provide a real quantification of the benefits of this product. It skips over risks and alternatives, too.
Earaches affect millions of children and there are few options available to treat the symptoms. This problem has contributed to overuse of antibiotics which are not appropriate treatment for most pediatric ear infections. If pediatricians were able to offer an effective treatment for symptom relief, this would be useful for parents and pediatric patients and ease pressures to prescribe unneeded antibiotics.
A new approach to avoiding antibiotics for earaches may be great — or too good to be true. We can’t tell from the evidence at hand.
The news release does not discuss costs, which is surprising. On Amazon, the cost is $12 for two ClearPop lollipops, more than you might pay out of pocket if you have insurance that covers antibiotics but still relatively cheap.
The release does not adequately quantify the benefits of the lollipops. It says:
“Children diagnosed with Acute Otitis Media, or ear infection, consumed the xylitol and Vitamin C-based product in pediatric offices. After 20 minutes, 88.5% reported their ear pain dramatically reduced or vanished. The earache episode was totally resolved for 80%.”
It does not explain how many children were studied. Is it 88.5% of 100 kids? Is it 88.5% of 50 kids? As it turns out, the number is 88.5% of 25 kids, meaning 22 kids. The release should say, “Out of the 25 children studied, 22 reported their ear pain reduced by X on a scale of Y.”
Using 88.5% is also misleading (on the part of the study report and the press release) because it doesn’t include in the denominator the number of subjects who stopped the treatment.
There were no risks mentioned for the lollipop device or for the ingredients but we give them a pass on this criteria since harms appear minimal. It’s worth noting that there can be a harm if persistent ear pain that is not resolved by use of the lollipop is not given medical attention.
The release says “link to full study here,” and we’re betting that most people never click on the link. If they were to do so, they would see that it does not appear to have been published in a peer reviewed journal. It was conducted in a very small group of patients. There was no control group. And it includes findings such as, “All patients enjoyed the lemony taste of the pop.” That sounds more like marketing that science.
The study report is deeply flawed. In addition to the above, there were only two physicians administering the treatment and it’s not clear how they were recruited or their relationship to the product. The lack of control group is particularly troubling because a) the described mechanism of action of the clearpop seems to be no different than what any lollipop or hard candy might achieve and b) the placebo effect alone could be huge.
As readers of this site know, we are reluctant to give this distinction, but in this case we feel it was warranted. Instead of just acknowledging that earaches are a bother and — as we note above — could potentially be signs of more serious illness, the release stokes fears, saying:
“Due to increasing concern about antibiotic overuse and its links to obesity, celiac disease, and Superbugs, the American Academy of Pediatrics now recommends against the use of antibiotics to treat routine ear infections in children over 2.”
The question is: Do you need to run and buy a product for a problem that likely will go away? Antibiotic or no antibiotic, the release seems to be trying to scare people into buying the product.
In addition, the release propagates the idea that antibiotics would work for ear infections but that doctors are just “reluctant to prescribe” them. This is a problematic idea that could lead to mistrust and pressure to prescribe in the pediatrician’s office.
No confusion here. The release is clearly a promotional vehicle for ClearPop which is noted in the dateline and throughout the copy. It also provides links back to the ClearPop website and states that the creator of Clearpop also started and leads the company.
The news release makes no comparisons between this product and the efficacy of antibiotics or other pain relief drugs such as Tylenol, Motrin, aspirin and others that come in pediatric formulations.
The news release states clearly where the product is available.
The news release does not establish the novelty of the product. This is particularly notable because it seems there is little difference between this or any other lollipop except for the addition of Vitamin C. Stating that the shape of the lollipop is patented and “optimized to pull congestion out of the middle ear and into the mouth” doesn’t prove it is more effective than other lollipops that come in many shapes and sizes.
The release does contain unjustifiable language, such as in the headline “Clinical study finds a specialized lollipop can end a kid’s earache in nine of ten cases,” but we won’t double-ding the source since we’ve already commented on most of these concerns under other criteria.