The results of the ELVIS-Kids randomised controlled trial were presented by Professor Steve Cunningham from Child Life and Health, University of Edinburgh, UK.

He said: “Children have up to 10 to 12 upper respiratory tract infections, what we refer to as colds, per year, which have a big impact on them and their families. There are medicines to improve symptoms, such as paracetamol and ibuprofen, but no treatments that can make a cold get better quicker.”

ELVIS-Kids Chief Investigator Dr Sandeep Ramalingam, consultant virologist, NHS Lothian, Edinburgh, UK, had noted that salt-water solutions are often used by people in South Asia, as nasal irrigation and gargling, to treat a cold and wanted to explore if this clinical benefit could be replicated in a large study.

The research team recruited 407 children aged up to six years to a study where they were given either hypertonic saline ~2.6% (salt-water) nasal drops or usual care when they developed a cold. Overall, 301 children developed a cold; for 150 of these, their parents were given sea salt and taught to make and apply salt-water nose drops to the children’s noses (three drops per nostril, a minimum of four times per day, until well) and 151 children had usual cold care.

Professor Cunningham explains: “We found that children using salt-water nose drops had cold symptoms for an average of six days where those with usual care had symptoms for eight days. The children receiving salt water nose drops also needed fewer medicines during their illness.

“Salt is made up of sodium and chloride. Chloride is used by the cells lining the nose and windpipes to produce hypochlorous acid within cells, which they use to defend against virus infection. By giving extra chloride to the lining cells this helps the cells produce more hypochlorous acid, which helps suppress viral replication, reducing the length of the virus infection, and therefore the duration of symptoms.”

When children got salt-water nose drops, fewer households reported family members catching a cold (46% vs 61% for usual care). Eighty-two per cent of parents said the nose drops helped the child get better quickly and 81% said they would use nose drops in the future.

Professor Cunningham added: “Reducing the duration of colds in children means that fewer people in their house also get a cold, with clear implications for how quickly a household feels better and can return to their usual activities like school and work etc.

“Our study also showed that parents can safely make and administer nose drops to their children and therefore have some control over the common cold affecting their children.”

Professor Alexander Möeller is Head of the ERS Paediatric Assembly and Head of the Department for Respiratory Medicine at the University Children’s Hospital Zurich, Switzerland, and was not involved in the research. He said: “This is an important study that is the first of its kind to investigate the impact of salty nose drops in children with colds. Although most colds usually don’t turn into anything serious, we all know how miserable they can be, especially for young children and their families.

“This extremely cheap and simple intervention has the potential to be applied globally; providing parents with a safe and effective way to limit the impact of colds in their children and family would represent a significant reduction in health and economic burden of this most common condition.”

The team hope to further investigate the effect of saltwater nose drops on wheeze during colds, after initial results from this study showed that children who received the drops had significantly fewer episodes of wheeze (5% vs 19%).

Two in three parents say their child ages 5-12 uses personal audio devices, with half of parents of children ages 5-8 reporting elementary-aged kids use a device.

Among parents whose children use headphones and earbuds, half say kids spend at least an hour a day using them while one in six say a typical day for their child includes at least two hours of use, according to the University of Michigan Health C.S. Mott Children’s Hospital National Poll on Children’s Health.

“Over recent years we’ve mostly been concerned about teens overusing audio devices. But earbuds have become increasingly popular and prevalent among younger kids, exposing them to more intense noise on a regular basis,” said Susan Woolford, M.D., M.P.H., Mott pediatrician and co-director of the Mott poll.

“Noise exposure risks to young children have historically involved loud singular events like concerts or fireworks, but parents may underestimate the potential harm from excessive use of listening devices. It may be difficult to know whether their child’s exposure to noise is healthy.”

Children are most likely to use these devices at home, school and in the car, report findings show. About a fourth of parents also say children occasionally use audio devices on airplanes while less than 10% say kids use them on the bus, outside or in bed.

Half of parents agree that headphones or earbuds help keep their child entertained.

The American Academy of Pediatrics released a statement in 2023 on the need to reduce noise risks to children, with increasing evidence that children and teens may be more exposed through personal listening devices.

Prolonged or extreme exposure to high volumes of noise can result in long term health issues, including hearing loss or tinnitus, Woolford says.

“Young children are more vulnerable to potential harm from noise exposure because their auditory systems are still developing. Their ear canals are also smaller than adults, intensifying perceived sound levels,” Woolford said.

“Tiny hair cells inside the inner ear pick up sound waves to help you hear. When these get damaged or die, hearing loss is irreversible.”

Noise exposure among children can also affect their sleep, academic learning, language, stress levels and even blood pressure, she adds.

More parents of children aged 9-12 years than 5-8 years report their child uses headphones or earbuds and daily use was also more likely to be higher among the older age group, the poll suggests.

But only half of parents share they’ve tried to limit their child’s audio device usage, citing strategies such as asking the child to take a break, having set hours for use and using a timer.

Parents whose child uses headphones for more than two hours a day are also less likely to set time or volume limits, compared to parents who report less headphone use for their child.

Woolford offers four tips to reduce risks of noise exposure to children through headphones and earbuds:

Monitor volume levels

Parents can minimize the negative impact of audio device usage by monitoring and adjusting the child’s volume and time on devices, Woolford says.

She recommends parents follow the 60/60 rule – children should be limited to no more than 60 minutes of audio devices a day at no more than 60% of the maximum volume.

The sound level on listening devices that are less than 70 dBA (relative loudness of decibels heard) are very unlikely to cause noise-related damage.

“A good way to tell if an audio device is too loud is if a child wearing headphones can’t hear you when you’re an arm’s length away,” she said.

Parents can also limit their child’s risk by setting specific hours for audio device use or using a timer to keep track.

Use noise cancelling or volume limiting headphones

Parents should consider the risk of noise exposure when purchasing audio devices for their child by checking the information on device packages to identify products that limit the volume.

But some products marketed as “kid safe,” Woolford warns, do not limit the volume to 70 decibels.

However, children should avoid using noise-cancelling listening devices in situations when perception of sounds is crucial for safety.

“Noise-cancelling devices may help prevent children from increasing the volume to levels that are too high,” Woolford said. “But these devices shouldn’t be used when a child is engaged in activities where it’s important to hear their surroundings for their safety, such as walking or bike riding.”

Ensure kids take breaks from personal listening devices

Parents should help children intentionally have daily “device-free” time, Woolford says. This may involve putting away or locking the child’s audio devices when time limits are up.

They may also encourage kids to enjoy things like music on a low volume in their rooms instead of using earbuds to reduce noise intensity.

Personal audio devices should also be avoided when children are sleeping or at bedtime, Woolford says.

Be mindful of early signs of hearing loss

If parents feel their child may be at risk of hearing loss due to using audio devices, Woolford recommends checking with a pediatrician, an audiologist, or an ENT (ear, nose and throat) specialist.

“Early signs of hearing loss may include asking for repetition, hearing ringing noises often, speaking loudly to people nearby, delayed speech, or lack of reaction to loud noises,” Woolford said.

“Healthcare providers may be of assistance to parents by offering a simple explanation about hearing loss to help the child understand the reasons for limiting their use of audio devices.”

Published today in JAMA, the research letter points to a coming wave of supplychain disturbances if the Food and Drug Administration (FDA) moves to pull oral phenylephrine from the shelves, as recommended by an FDA advisory panel in 2023 that found the medication ineffective.

The researchers analyzed purchases of phenylephrine and pseudoephedrine—the only two nasal decongestants currently approved by the FDA—by pharmacies and major retail outlets. Between 2012 and 2021, American pharmacies purchased 19.8 billion units of phenylephrine products, compared to 13.2 billion units of pseudoephedrine products.

The researchers showed that pseudoephedrine is usually sold as a stand-alone product; phenylephrine, however, tends to be combined with several drugs and packaged as multi-symptom products. If the FDA opts to follow the advisory panel’s recommendation, most multi-symptom products will be pulled from the shelves, as there are still few pseudoephedrine-based alternatives on the market.

The study points to a need for continued reform of the over-the-counter drug review process, said lead author Timothy Anderson, M.D., M.A.S., a primary care physician, health services researcher and assistant professor of medicine at Pitt.

“The FDA needs to hold over-the-counter drugs to a standard of effectiveness similar to that of prescription drugs,” Anderson said. “A comparable pathway is needed for drugs that are sold over the counter as exists for post-approval monitoring of the risks and efficacy of prescription drugs. This will require a substantial investment in infrastructure to expand capacity.”

Other authors on the study were Katie J. Suda, Pharm.D., M.S. and Walid F. Gellad, M.D., M.P.H., both of Pitt; and Mina Tadrous, Pharm.D., Ph.D., of the University of Toronto.

This research was supported by the National Institute on Aging (K76AG074878) and the Canadian Institutes of Health Research (#202109).

“We found that adults with hearing loss who regularly used hearing aids had a 24% lower risk of mortality than those who never wore them,” said lead investigator Janet Choi, MD, MPH, an otolaryngologist and assistant professor of medicine at the University of Southern California Keck School of Medicine in Los Angeles. “These results are exciting because they suggest that hearing aids may play a protective role in people’s health and prevent early death.”

As background, the authors noted that hearing loss is a known factor for negative health outcomes and mortality. But to date it has not been established whether hearing aid use is associated with lower mortality.

The researchers evaluated data on 9,885 adults (age 20 years and older) who participated in the (USA) National Health and Nutrition Examination Survey between 1999 and 2012 and completed audiometry and hearing aid use questionnaires, revealing 1,863 adults with hearing loss.

Main measures included hearing loss, hearing aid use (never users, non-regular users, and regular users) and death (up to 2019).

Of the subjects with hearing loss, 237 were regular hearing aid users (i.e. wearing a hearing aid at least once a week, five hours a week or half the time) and 1,483 were never-users. Those wearing a hearing aid once a month or less were categorized as non-regular users.

The investigators reported a 24% difference in mortality risk between regular hearing aid users and never-users. This finding held even after adjustments were made for degree of hearing loss (from mild to severe), age, ethnicity, income, education other demographics and medical history.

They found no difference in mortality risk between non-regular users and never users, suggesting that occasional hearing aid use did not extend life.

The authors concluded, “Regular hearing aid use was associated with lower risks of mortality than in never users in US adults with hearing loss when accounting for age, hearing loss, and other potential confounders. Future research is needed to investigate the potential protective role of hearing aid use against mortality for adults with hearing loss.”

Acute sinusitis is one of the most common causes for children to be put on antibiotic medications, with patients in the United States filing nearly 5 million antibiotic prescriptions every year to treat the condition. The drugs amoxicillin and amoxicillin-clavulanate make up most of those prescriptions, but there is a lack of consensus on which should be first-line for children.

In a new study published today in JAMA and led by researchers at Brigham and Women’s Hospital, a founding member of the Mass General Brigham healthcare system, scientists analyzed the treatment outcomes of over 300,000 children who were prescribed either of the two drugs. They found that there was no difference in the rates of treatment failure — that is, having to go on a new course of antibiotics or seek additional treatment for sinusitis or complications — between patients prescribed amoxicillin and amoxicillin-clavulanate. Treatment failure was so rare, in fact, that the study’s authors say that physicians should be confident that either medication will clear a case of acute sinusitis that requires antibiotics. But the risk of adverse events, especially gastrointestinal symptoms and yeast infections, were higher among those prescribed amoxicillin-clavulanate.

“This study adds recent, actionable data and evidence to inform what antibiotic a clinician should choose to treat a child with acute bacterial sinusitis,” said lead author Timothy Savage, MD, MPH, MSc, an associate epidemiologist in the Brigham’s Division of Pharmacoepidemiology and Pharmacoeconomics. “As seen from this study, there’s no difference in the treatment failure rate regardless of which of these two antibiotics you choose.”

Amoxicillin-clavulanate is believed to treat a wider range of bacteria than amoxicillin, but it is also associated with more gastrointestinal side effects. Scientists also worry that in the long-term, overprescribing amoxicillin-clavulanate may accelerate the rate at which infectious bacteria develop antimicrobial resistance. Doctors have therefore wondered whether the benefits of prescribing amoxicillin-clavulanate to children with acute sinusitis outweigh the short- and long-term risks.

The researchers pulled data from 320,141 clinical cases of children diagnosed with acute sinusitis and compared whether children on amoxicillin or amoxicillin-clavulanate were more likely to undergo treatment failure. They discovered that there was no difference in the rates of treatment failures associated with either medication. Treatment failure in general was exceedingly rare; less than two percent of prescriptions failed, most of which were corrected by an outpatient medication change. Only 0.1% of children had failures so severe that they required a visit to the emergency room or hospitalization.

The clinical data showed that adverse events were somewhat rare but more frequent among patients treated with amoxicillin-clavulanate, occurring in 2.3% of patients treated with amoxicillin-clavulanate and 2% of patients treated with amoxicillin. Patients treated with amoxicillin-clavulanate had a 15% increased risk of gastrointestinal side effects and 33% higher risk of yeast infections compared to patients treated with amoxicillin. The study’s authors conclude that the more narrow-spectrum amoxicillin may be the best first-line choice to combat acute sinusitis.

“Our study shows that there are more adverse events when amoxicillin-clavulanate is used,” Savage said. “Based on these data, physicians should seriously consider prescribing amoxicillin as a first line of defense against acute sinusitis.”

Not all acute sinusitis cases are caused by bacterial infections; a previous study found that viruses may be responsible for up to 32% of instances. Still, because the symptoms of bacterial and viral sinusitis can be nearly indistinguishable, many doctors opt to first treat a patient with antibiotics and monitor whether the infection clears. Around 85% of children that present with acute sinusitis receive an antibiotic, with amoxicillin and amoxicillin-clavulanate accounting for 65% of those prescriptions. The current study did not include microbiologic data and the authors could not discern whether acute sinusitis diagnoses were due to viral or bacterial infections. As this was not a randomized clinical trial, the study authors also acknowledge the possibility that residual bias could have impacted the results, although they re-analyzed the data several different ways to try to mitigate this, with no difference in the results.

Two previous studies that compared clinical outcomes of the two drugs were conducted more than 20 years ago. Those analyses showed that both medications alleviated symptoms at similar rates, but both studies were limited by a combined sample size of under 300 patients. Bacterial species have evolved significantly in the last twenty years, a fact that convinced Savage and his team to launch a new, larger study comparing treatment failure rates of both drugs.

“If a physician is trying to decide between these two drugs, they can look at these results and see that 98% of kids got better regardless of whether they were prescribed amoxicillin or amoxicillin-clavulanate,” Savage said. “The chance that a child will end up in the hospital after using these drugs is less than one in a thousand. That should provide some reassurance that a child is going to do pretty well regardless of the antibiotic.”

Disclosures: Savage reports an institutional contract from UCB outside the submitted work, and co-author Krista Huybrechts reports institutional contracts from UCB and Takeda outside the submitted work.

Funding: This study was supported by the Eunice Kennedy Shriver National Institute of Child Health & Human Development (T32HD040128 and K08HD110600). The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health. Dr. Savage had full access to all the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis.

Paper cited: Savage TJ et al. “Treatment Failure and Adverse Events after Amoxicillin-Clavulanate vs. Amoxicillin for Pediatric Acute Sinusitis” JAMA DOI: 10.1001/jama.2023.15503

The researchers will present their results today at the fall meeting of the American Chemical Society (ACS). ACS Fall 2023 is a hybrid meeting being held virtually and in-person Aug. 13–17, and features about 12,000 presentations on a wide range of science topics.

A video on the research is available at www.acs.org/Earaches.

“We initially conceived of this idea by looking at the household cleaner bleach. Even though it has been used since the 19^th century, bacteria do not appear to have developed any widespread resistance to this cleaner,” says Rong Yang, Ph.D., the project’s principal investigator.

But Yang quickly warns that people should not treat infections with bleach. The solution sold at stores is highly concentrated and caustic, but when used in a properly controlled manner at extremely low concentrations, the active ingredient in bleach is considered compatible with living tissue.

After realizing that the active ingredient in the household cleaner could circumvent antibiotic resistance, the researchers, who are at Cornell University, decided to tackle a nearly universal childhood scourge: acute ear infections. These infections affect more than 95% of children in the U.S., and treatment typically requires taking antibiotics for five to 10 days. However, these regimens can cause problematic side effects, leading some families to discontinue the medication prematurely, particularly if symptoms resolve. But using these medications improperly can speed up the development of antibiotic resistance, which makes infections more difficult, if not impossible, to treat. This issue ranks among the biggest threats to global health, according to the World Health Organization.

Bacteria have more success fighting against some substances than others. Hypochloric acid from bleach belongs to a family of compounds, known as hypohalous acids, to which bacteria have yet to develop any significant resistance — most likely because of the numerous ways these highly reactive acids damage microbial cells, Yang says.

Because these substances break down quickly, Yang and her colleagues sought to generate one of them on an as-needed basis behind the eardrum in the middle ear, where ear infections occur. They found inspiration in an enzyme from giant kelp, which converts hydrogen peroxide (H₂O₂) to hypobromous acid (HOBr), a chemical relative of bleach.

A frequent cause of ear infections, the bacterium Streptococcus pneumoniae produces H₂O₂ to fight off other microbes. To mimic the kelp enzyme, which contains the metal vanadium, Yang and her colleagues designed nanowires made of vanadium pentoxide (V₂O₅). These produce HOBr only in the presence of the H₂O₂-producing bacteria, and their rod-like shape helps to keep them in place by reducing their ability to diffuse into body fluids.

In tests on chinchillas, which contract ear infections from the same pathogens as human children, they succeeded in eliminating most of the S. pneumoniae. Yang and colleagues found that after treatment with the nanowires, the animals’ once-inflamed eardrums returned to normal. Meanwhile, tests in healthy animals found evidence that the treatment did not interfere with hearing.

For these experiments, the researchers injected the nanowires directly into the middle ear. In more recent work in chinchillas, they developed a less invasive, more practical method for delivering the wires. By decorating the nanowires with peptides known to transport small particles across the eardrum, Yang and her team found they could deliver the treatment topically as a gel deposited into the ear canal. Once the gel was applied, the nanowires within it went through the intact tissue. They are also exploring other approaches for passing the nanowires through the eardrum.

Because other ear-infection-causing bacteria do not produce H₂O₂, the researchers are currently examining whether this system is effective in the presence of microbes other than S. pneumoniae, and how they might adapt it to fight the other bugs.

The researchers have not yet done studies to determine how long the system stays in place, although their evidence suggests the nanowires drain out of the middle ear after the infection clears. However, Yang suspects they could adapt the nanowires’ properties to stay in place for long periods afterward. This latter approach could make it possible to prevent recurrent infections that plague many children.

“If the bacteria return, the system could restart, so children wouldn’t need antibiotics repeatedly and breed more resistance along the way,” Yang says.

The researchers acknowledge support and funding from the National Institute on Deafness and Other Communication Disorders.

This research was presented at a meeting of the American Chemical Society.

“Five million kids in the U.S. get prescribed antibiotics for sinusitis each year,” said lead author Nader Shaikh, M.D., pediatrician at the University of Pittsburgh Medical Center and professor of pediatrics and clinical and translational science at the university. “Our study suggests that only half of these kids see an improvement in symptoms with antibiotic use, so by identifying who they are, we could greatly reduce unnecessary antibiotic use.”

Between February 2016 and April 2022, the investigators enrolled 515 children aged 2 to 11 who had been diagnosed with acute sinusitis based on clinical criteria.

The researchers took swabs from inside the nose, like a COVID-19 test, from each child and tested them for the three main types of bacteria involved in sinusitis.

The trial was designed to determine whether symptom burden differed in subgroups testing positive for nasopharyngeal Streptococcus pneumoniae, Haemophilus influenzae, or Moraxella catarrhalis on bacterial culture and by the presence of colored nasal discharge.

The subjects received oral amoxicillin (90 mg/kg/d) and clavulanate (6.4 mg/kg/d) (n = 254) or placebo (n = 256) for 10 days.

The primary outcome was symptom burden during the 10 days after diagnosis.

Most of the 510 subjects were aged 2 to 5 years-old (64%).

Using standard testing, the investigators reported that mean 10-day symptom scores were lower among the subjects in the amoxicillin/clavulanate group compared with those in the placebo group

Length of time to symptom resolution was lower for subjects in the antibiotic group (7.0 days) than in the placebo group (9.0 days).

Subjects who tested positive for bacteria achieved a better resolution of symptoms with antibiotic treatment then those who did not have bacteria, suggesting that testing for bacteria might be a simple way to detect children who could benefit from antibiotic treatment and avoid giving antibiotics to children who won’t.

“If antibiotics aren’t necessary, then why use them?” said Shaikh. “These medications can have side effects, such as diarrhea, and alter the microbiome, which we still don’t understand the long-term implications of. Overuse of antibiotics can also encourage antibiotic resistance, which is an important public health threat.”

The authors concluded, “In children with acute sinusitis, antibiotic treatment had minimal benefit for those without nasopharyngeal bacterial pathogens on presentation, and its effects did not depend on the color of nasal discharge. Testing for specific bacteria on presentation may represent a strategy to reduce antibiotic use in this condition.”

“These findings demonstrate that cerebrospinal fluid transport comprises an accessible route for gene delivery to the adult inner ear and may represent an important step towards using gene therapy to restore hearing in humans,” said Maiken Nedergaard, MD, DMSc, senior author of the new study, which appears in the journal Science Translational Medicine.

Nedergaard is co-director of the Center for Translational Neuromedicine at University of Rochester and the University of Copenhagen.  The study was the product of a collaboration between researchers at the two universities and a group led by Barbara Canlon, Ph.D. in the Laboratory of Experimental Audiology at the Karolinska Institute in Stockholm, Sweden.

The number of people worldwide predicted to have mild to complete hearing loss is expected to grow to around 2.5 billion by mid-century.  The primarily cause is the death or loss of function of hair cells found in the cochlea—which are responsible for relaying sounds to the brain—due to mutations of critical genes, aging, noise exposure, and other factors.

While hair cells do not naturally regenerated in humans and other mammals, gene therapies have shown promise and in separate studies have successfully repaired the function of hair cells in neo-natal and very young mice.  However, as both mice and humans age, the cochlea, already a delicate structure, becomes enclosed in temporal bone. At this point, any effort to reach the cochlea and deliver a gene therapy via surgery risks damaging this sensitive area and altering hearing.

In the new study, the researchers describe a little understood passage into the cochlea called the cochlear aqueduct. While the name conjures images of monumental stone architecture, the cochlear aqueduct is thin boney channel no larger than a single strand of hair.  Suspected to play a role in balancing pressure in the ear, new study shows that that the cochlear aqueduct also acts as a conduit between the cerebrospinal fluid found in the inner ear and the rest of the brain.

Scientists are developing clearer picture of the mechanics of glymphatic system, the brain’s unique process of removing waste first described by the Nedergaard lab in 2012.  Because the glymphatic system pumps cerebrospinal fluid deep into brain tissue to wash away toxic proteins, researchers have been eyeing it as a potentially new way to deliver drugs into the brain, a major challenge in developing drugs for neurological disorders.

Researchers have also discovered that the complex movement of fluids driven by the glymphatic system extend to the eyes and the peripheral nervous system, including ear.  The new study represented an opportunity to put the drug delivery potential of the glymphatic system to the test, while at the same time targeting a previously unreachable part of the auditory system.

Employing a number of imagining and modeling technologies, the researchers were able to develop a detailed portrait of how fluid from other parts of the brain flows through cochlear aqueduct and into the inner ear.  The team then injected an adeno-associated virus into the cisterna magna, a large reservoir of cerebrospinal fluid found at the base of the skull.  The virus found its way into the inner ear via the cochlear aqueduct, delivered a gene therapy that expresses a protein called vesicular glutamate transporter-3, which enable the hair cells to transmit signal and rescued hearing in adult deaf mice.

“This new delivery route into the ear may not only serve the advancement of auditory research, but also prove useful when translated to humans with progressive genetic-mediated hearing loss,” said Nedergaard.

Additional co-authors of the study include: Barbara Mathiesen, Leo Miyakoshi, Peter Bork, Natalie Hauglund, Ryszard Stefan, Yuki Mori, and Kjeld Mollgard with the University of Copenhagen; Christopher Cederroth, Evangelia Tserga, Corstiaen Versteegh, Niklas Edvall, and Barbara Canlon with the Karolinska Institute; and Jeffery Holt with Harvard University.  The research was supported with funds from the Lundbeck Foundation, the Novo Nordisk Foundation, the National Institute of Neurological Disorders and Stroke, the Knut and Alice Wallenberg Foundation, the Karolinska Institute, the Tysta Skolan Foundation, Hörselforskningsfonden, the European Union’s Horizon 2020 Research and Innovation Programme, the Danish Society for Neuroscience, the U. S. Army Research Office, the Human Frontier Science Program,  the Dr. Miriam and Sheldon G. Adelson Medical Research Foundation, Simons Foundation, the Jeff and Kimberly Barber Fund, and Foundation Pour L’Audition.

“We wanted to quantify the national impact of smell disorders resulting from COVID,” said Neil Bhattacharyya, MD, FACS, Professor of Otolaryngology at Mass Eye and Ear. “With this data we can understand, in big numbers, how many people lost their sense of smell or taste due to COVID infection and how many people never fully recovered those senses.”

The retrospective study utilizes data from the 2021 National Health Interview Survey (NHIS), a branch of the Centers for Disease Control (CDC), which includes survey data from 29,696 adults. In the NHIS data, COVID patients were asked about the severity of their symptoms, any loss of taste or smell, and their recovery of those senses.

The research team reported that about 60 percent of surveyed participants infected with COVID experienced a loss of smell and about 58 percent experienced loss of taste. Additionally, not all the patients experienced a full recovery of their senses once they recovered from their infection.

The study found that around 72 percent of patients fully recovered their sense of smell, but 24 percent only had a partial recovery and over 3 percent had no recovery of their sense of smell at all. Similarly, of those who experienced a loss of taste due to COVID, about 76 percent fully recovered the sense, while 20 percent only partially recovered and over 2 percent did not recover at all. That amounted to almost 28 million Americans potentially left with a decreased sense of smell after COVID infection.

Bhattacharyya said one of the motivations for the study was a patient he saw who lost 50 pounds due to his COVID-related smell loss.

“The patient wasn’t eating and became very sick and very depressed because of the loss of smell,” Bhattacharyya said. “When you hear about COVID-related smell loss, you think most people get it back and are fine. But there is a substantial number of people who don’t recover it.”

The study also found that there is a correlation between COVID symptom severity and loss of smell or taste. As symptom severity increased, the percentage of patients with smell or taste loss also increased. Moreover, the likelihood of smell and taste sensory recovery also decreased with more severe COVID symptoms.

The authors noted that since smell and taste often work together, it may be difficult for patients to self-report which senses have or have not recovered. However, there remains a large population of patients who experience loss of smell and taste as an after-effect of COVID.

While the study is novel due to its national population sample, the dataset focuses only on patients treated in 2021. This means that patients before and after 2021 were not taken into consideration, and if an individual recovered their sense of smell or taste after 2021, it was not documented in the data. In addition, rates of loss of smell or taste due to infection from variants of COVID that arose after 2021 likely vary from the rates detected in this study.

Although there currently isn’t a standard treatment for patients with smell and taste deficits, the researchers note these findings can help providers counsel patients who have lost their sense of smell or taste due to COVID and track recovery rates.

“The value of this study is that we are highlighting a group of people who have been a bit neglected,” Bhattacharyya said. “Losing your sense of smell or taste isn’t as benign as you may think. It can lead to decreased eating for pleasure and, in more extreme cases, it can lead to depression and weight loss.”

Disclosures: None

Funding: None

Paper cited: Mitchell, M. et al. “Smell and Taste Loss Associated with COVID Infection” The Laryngoscope DOI: 10.1002/lary.30802

It’s a more convenient alternative to intravenous infusion—the usual method of administration for these patients—but the potential for overuse means that it should be reserved for those in whom other treatment approaches have failed, caution the researchers.

Several clinical trials have shown that intravenous ketamine is effective for chronic headache. But it typically requires the input of a pain specialist to adjust the dose and monitor side effects, so limiting its use in outpatient clinics, say the researchers.

And while there is some evidence that intravenous ketamine can be used for headache disorders, such as migraine and cluster headache, it’s not clear if ketamine could also be safely used for chronic migraine that is resistant to treatment.

To try and find out, the researchers retrospectively reviewed the outcomes and experiences of people given nasal ketamine spray for chronic refractory migraine between January and February 2020 at one single specialist headache centre.

During this period, 242 people were prescribed a nasal ketamine spray, 169 of whom (80% women; average age 44) agreed to be interviewed.

Most reported daily headache (67.5%) and nearly 85% had tried more than 3 types of preventive drugs. They currently used around 2 of these.

The most common reasons for wanting to use nasal ketamine spray included partial responses to reliever painkillers (100, 59%) and preventive drugs (52, 31%), previous benefit from intravenous ketamine (38, 22.5%), and the failure of intravenous lidocaine (22,13%).

Forty one (25%) and 46 (28%) patients were offered nasal ketamine spray before and after intravenous ketamine infusion, respectively; 47% never received intravenous ketamine.

Overall, they said they used the nasal spray 6 times, over an average of 10 days a month. Nearly half (49%) said the spray was “very effective” while  39.5% found it “somewhat effective.” Over a third (35.5%) said their quality of life was “much better.”

Compared with other reliever drugs, 73 (43%) thought the nasal spray was “much better” and 50 (29.5%) felt it was “somewhat better.”

Almost three quarters said they used fewer pain reliever meds when using nasal ketamine spray. At the time of the interview, almost two thirds (65%) were still using the spray.

Nearly 3 in 4 (74%) reported at least one side effect, of which fatigue and double/blurred vision were the most common, followed by cognitive effects, such as confusion/dissociation, vivid dreams, hallucinations. But these were mostly temporary.

The study was based on a single tertiary headache centre, and comprised primarily young White women, so the findings may not be more widely applicable, say the researchers. And most participants used the spray alongside other meds, making it difficult to assess the therapeutic benefit of the spray by itself, they add.

The most effective, safe dose also remains to be determined in the absence of any clinical guidelines, they point out. And at the time of writing, nasal ketamine spray had not been formally approved for headache or pain.

Dependency is a potential drawback, the researchers add, highlighting that their study showed 23 people used the spray daily and 37 used it more than 15 days/month.

“[This] should be addressed carefully and individually, as some may respond only to repeated [intranasal] ketamine while some may overuse it,” they caution. “Clinicians should only consider the use of a potentially addictive medication such as ketamine for significantly disabled patients with migraine,” they advise.

But they conclude: “This retrospective study suggests that [intranasal] ketamine may offer a pain-relieving effect with limited [side effects] for [refractory chronic migraine] in the outpatient setting,” but further clinical trials are needed to confirm the findings.

“The evidence is building that hearing loss may be the most impactful modifiable risk factor for dementia in mid-life, but the effectiveness of hearing aid use on reducing the risk of dementia in the real world has remained unclear. Our study provides the best evidence to date to suggest that hearing aids could be a minimally invasive, cost-effective treatment to mitigate the potential impact of hearing loss on dementia,” said author Professor Dongshan Zhu of Shandong University in Jian, China.

The investigators retrospectively analyzed data from the UK Biobank, a population-based cohort study, which recruited adults aged 40–69 years between 2006 and 2010 across 22 centers in England, Scotland, and Wales. For this new analysis, the researchers used data from 437,704 subjects.

The average age of subjects at registration was 56 years-old, and the average follow-up was 12 years.

The researchers used standard statistical tools to estimate the correlation between self-reported hearing aid use status (hearing loss with or without hearing aids) at baseline and ensuing risk of dementia (all-cause dementia, Alzheimer’s disease, vascular dementia, and non-Alzheimer’s disease non-vascular dementia).

Hearing loss information and data on hearing aid use was extracted from self-reported questionnaires.

The researchers obtained dementia diagnoses from hospital records and death-register data.

The investigators reported that about three-quarters of the subjects (325,882/437,704) had no hearing loss. The remaining one-quarter (111,822) had some level of hearing loss.

Among those with hearing loss, 11.7% (13,092 / 111,822) used hearing aids.

After adjusting for other factors, the researchers reported a 1.7% risk of dementia for subjects with hearing loss who did not use hearing aids, compared to 1.2% for subjects either without hearing loss or with hearing loss who used hearing aids. 

“Close to four-fifths of people experiencing hearing loss do not use hearing aids in the UK. Hearing loss may begin early in one’s 40s, and there is evidence that gradual cognitive decline before a dementia diagnosis can last 20 to 25 years. Our findings highlight the urgent need for the early introduction of hearing aids when someone starts to experience hearing impairment. A group effort from across society is necessary, including raising awareness of hearing loss and the potential links with dementia, increasing accessibility to hearing aids by reducing cost, and more support for primary care workers to screen for hearing impairment, raise awareness, and deliver treatment such as fitting hearing aids,” said Professor Zhu.

Writing in a Linked Comment, Professor Gill Livingston and Dr. Sergi Costafreda, University College London, who were not involved in this research, said: “With the addition of Jiang and colleagues’ work, the evidence that hearing aids are a powerful tool to reduce the risk of dementia in people with hearing loss, is as good as possible without randomised controlled trials, which might not be practically possible or ethical because people with hearing loss should not be stopped from using effective treatments. Dementia is not only an illness that affects the individual and their family but can also be expensive. However, using hearing aids to prevent dementia has been found to be cost-effective and cost-saving. In the USA, hearing aids have become available to purchase over the counter, thus making them more accessible. The evidence is compelling that treating hearing loss is a promising way of reducing dementia risk. This is the time to increase awareness of and detection of hearing loss, as well as the acceptability and usability of hearing aids.”

In laboratory animal studies, a molecule known as TriSb92, developed by researchers at the University of Helsinki, has been confirmed as affording effective protection against coronavirus infection. The molecule identifies a region in the spike protein of the coronavirus common to all current variants of the virus and inhibits its functioning.

“When administered nasally, the TriSb92 molecule is extremely effective in preventing infection, and experiments carried out in cell cultures indicate that it also encompasses the very latest variants, including XBB, BF7 and BQ.1.1,” explains Postdoctoral Researcher Anna R. Mäkelä from Professor Kalle Saksela’s research group.

Animal models have also demonstrated that, unlike face masks, the molecule can, when sprayed into the nose, prevent infection even after a few hours of exposure.

According to the researchers, the molecule remains fully functional at room temperature for at least 18 months, making it well suited for use as a nasal spray.

The results have been published in the Nature Communications journal.

Anticipation of future viral variants

While the worst stage of the coronavirus pandemic is, at least for the time being, behind us, nasally administered protection can be a crucial help in preventing the spread of the virus in the future.

“The latest variants effectively avoid the immune protection provided by both vaccines and the COVID-19 disease, and current vaccines are not effective in preventing transmission,” Mäkelä says.

Moreover, the nasal spray can protect those people from serious disease who do not gain sufficient immunity from vaccines, such as immunocompromised individuals and elderly.

According to the researchers, the molecule could also work against future animal-borne close relatives of SARS-CoV-2, which are expected to be the cause of entirely new coronavirus pandemics.

“Since the region in the coronavirus’s spike protein affected by the TriSb92 molecule has remained almost unchanged in all viral variants so far emerged, it can be assumed to be effective also against future SARS-CoV-2 variants,” Mäkelä confirms.

“The easily and inexpensively produced TriSb92 could be a very important first line of defence in curbing such a new pandemic, pending the development, production and distribution of vaccines,” she adds.

A copyable approach

According to the researchers, the sherpabody-technology used is also applicable to the prevention of many other viral diseases, particularly influenza and other respiratory viruses.

“The whole approach stems from a technical solution based on a binder protein platform developed in Finland, which was not originally intended for the development of an antiviral drug. It provides an opportunity for many other new initiatives based on the accurate identification of diseased cells or pathogens in patients,” Mäkelä says.

In the next stage, the molecule must be tested in clinical trials, after which it could be made commercially available.

“Successful commercialisation of the nasal spray could lead to the creation of a thriving Finnish business,” Mäkelä points out.