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New Natural Bioactive Molecules Effectively Relieve Cold And Flu Symptoms
Researchers have discovered that natural bioactive molecules, including lysozyme and lactoferrin (collectively termed the "Mucosal Immune Complex"), can effectively relieve cold and flu symptoms by protecting and strengthening the mucosal barrier function and reducing inflammation. A randomized, double-blind placebo-controlled study confirmed that formulas containing this complex, when combined with low-dose aspirin or other anti-inflammatory agents, significantly reduced symptoms, offering a promising alternative to traditional over-the-counter remedies that have been shown to potentially damage the mucosal barrier and increase inflammation.
Scientists at Applied Biological Laboratories Inc. Have identified how natural bioactive molecules can effectively relieve cold and flu symptoms by protecting the mucosal barrier function and reducing inflammation during these infections. Together, they call these molecules, which include lysozyme and lactoferrin, the "Mucosal Immune Complex."
The research, led by Nazlie Sadeghi-Latefi, Ph.D., highlights the importance of supporting mucosal barrier immunity to prevent and treat colds and flu. This work was recently presented at the American Chemical Society Fall 2023 Meeting on August 15, 2023.
Mucosal immunity is the body's first line of defense against invading pathogens, such as those causing the common cold and influenza. While the mucosal barrier functions primarily as a part of the innate immune response, it provides a crucial bridge to adaptive immunity. Once someone is infected, the mucosal immunity and barrier integrity determine the extent of the infection, and thus the illness severity and duration. Popular cold & flu remedies may do more harm than good A previous peer-reviewed study by researchers at Applied Biological Laboratories compared the effects of natural bioactive molecules to those of the most popular over-the-counter cough and cold medications using in vitro respiratory mucosal barrier models. The researchers found that these popular OTC medications damage the mucosal barrier and increase inflammation (the underlying cause of cold symptoms), which they say may translate to possibly worsening symptoms, prolonging infections, and increasing the risk of secondary infections. Smith Johnston, MD, clinical faculty at the University of Texas Medical Branch, former Medical Officer emeritus for NASA's Medical Operations Branch, and a member of Applied Biological Laboratories' scientific advisory board adds that decades of meta-analyses of clinical trials have found inconclusive evidence of safety and effectiveness for many popular over-the-counter common cold and flu medications. Although these medications often claim to provide the indicated symptomatic relief, they have not been shown to effectively reduce the severity and duration of illness better than a placebo. Many of these were approved for over-the-counter (monograph) marketing before the FDA required rigorous clinical trials to approve over-the-counter drugs. Lysozyme and Lactoferrin strengthen mucosal barrier immunity, block viral entry, and synergize with more specific COX inhibitors One of the key inflammatory signals in respiratory inflammation and cold symptoms involves prostaglandin generation via COX enzymes. When low doses of plant-based acetylsalicylic acid (aspirin), or other naturally derived COX inhibitors such as aloe vera extract were combined with lysozyme, lactoferrin, and menthol the anti-inflammatory effects through inhibition of COX-mediated inflammation and bradykinin-mediated IL-8 were even greater than with the COX inhibitor alone. Thus, this combination of natural bioactive molecules has powerful synergistic effects for relieving cold and flu symptoms. Unlike common OTC cold & flu remedies, which do not focus on inflammation at all, and which may damage the mucosal barrier, specific concentrations of natural bioactive ingredients like lactoferrin and lysozyme did not damage the mucosal barriers but strengthened it according to the previously mentioned peer-reviewed study. According to numerous other peer-reviewed studies, lactoferrin and lysozyme activate local innate immune cells, such as macrophages and dendritic cells, and may also bind to viruses, preventing them from docking and infecting respiratory epithelial cells. Clinical trial confirms the synergistic benefits of natural bioactive molecules with low-dose aspirin in treating cold & flu symptoms To confirm their findings and test their formulations clinically, researchers at Applied Biological Laboratories conducted a randomized, double-blind placebo-controlled multi-center study. Relief of sore throat, a measure of upper respiratory inflammation was assessed as the primary endpoint and reduction of other common cold symptoms such as nasal discharge and congestion, sneezing, sore/scratchy throat, cough, headache, malaise, and fever/chills, as assessed by the modified Jackson scores were measured as secondary endpoints. The trial assessed 179 participants who were randomly assigned to either placebo or one of three treatment groups each containing the mucosal immune complex and a mix of other anti-inflammatory ingredients. By the second day of the study, the treatment groups had a significant reduction of up to 4.59 points in modified Jackson scores, whereas the placebo group did not demonstrate any improvement in any category of Jackson scores. The researchers conclude that formulas containing the mucosal immune complex are an effective treatment for alleviating cold and flu symptoms, including nasal congestion, discharge, sneezing, sore throat, cough, headache, malaise, and fever/chills. Implications and Impact The potential implications of these results are significant, given the vast number of people affected by the common cold and flu every season. Every year, an average household shops for over-the-counter medications 26 times a year, spending an average of $338. To date, few studies have evaluated the impact of these medications on mucosal barrier integrity, which can affect symptom severity and susceptibility to secondary infections. In addition, clinical evidence that demonstrates the safety and effectiveness of cold and flu remedies has been scarce, even in FDA-approved medications. Meeting: American Chemical Society Fall 2023 MeetingWhat We Know — And Don't Know — About The FDA-approved Postpartum Depression Pill
Enlarge this image Postpartum depression affects up to 1 in 7 women. The first pill to treat it is expected to become available later this year, after the FDA approved it on Friday. Getty Images hide caption
toggle caption Getty ImagesPostpartum depression affects up to 1 in 7 women. The first pill to treat it is expected to become available later this year, after the FDA approved it on Friday.
Getty ImagesThe Food and Drug Administration has approved the first ever pill for treating postpartum depression, a potentially life-threatening condition that affects hundreds of thousands of new parents across the U.S. Each year.
Manufacturers Sage Therapeutics and Biogen Inc. Say the drug, Zurzuvae (zuranolone), will be commercially available in the fourth quarter of this year, which could be as soon as October.
The pill — to be taken once a day for 14 days — has shown promising results in two company studies, with some patients seeing benefits after just three days.
That's considerably faster than other antidepressants and much less invasive than the only other FDA-approved postpartum depression treatment on the market, which is also from Sage. It's delivered through IV during a 60-hour, $34,000 process.
Health The FDA approves the first pill specifically intended to treat postpartum depression The manufacturers have not said how much Zurzuvae will cost — so it's not clear how much insurance might cover, or how accessible the drug will be to the people who need it most. While anyone can develop postpartum depression, those from lower socioeconomic groups face a heightened risk.
Medical experts and maternal health groups say the drug could be a potentially game-changing option — especially if it's more affordable than the IV alternative, as many are hoping.
The nonprofit Postpartum Support International called it "welcome news for the estimated 500,000 women in the United States who report experiencing symptoms of this devastating and often misunderstood illness each year."
The Policy Center for Maternal Mental Health, a national think tank, lauded the drug as a "new ray of hope for individuals experiencing postpartum depression and for prescribing providers."
Life Kit What is postpartum depression? How to recognize the signs and get help "Throughout the U.S., there have been significant shortages of mental health care providers, including providers qualified to treat maternal mental health conditions," the center's executive director, Joy Burkhard, said in a statement. "It is absolutely game-changing that the mother's OB-GYN or midwife can now prescribe this new treatment without consulting or referring to a psychiatrist, and a mother is almost guaranteed to be well in two weeks."
Even so, experts say, Zurzuvae may not be the best option for everyone, and encourage women to consult with their health care provider about the best course of treatment.
Here's what to know if you or a loved one is curious about it — and given the prevalence of postpartum depression, that may be more people than you think.
Postpartum depression is a growing problemPostpartum depression, also called PPD, affects up to 1 in 7 moms and 1 in 10 dads. It's the most common complication for women who have just had a baby, according to health nonprofit March of Dimes.
And it appears to be on the rise: A recent analysis from the Centers for Disease Control and Prevention found that the rate that depression was diagnosed at delivery was seven times higher in 2015 than in 2000.
PPD often starts within one to three weeks of having a baby, and brings about strong feelings of anxiety, sadness and tiredness that can make it hard for new parents to take care of themselves and their baby.
Shots - Health News New Postpartum Depression Drug Could Be Hard To Access For Moms Most In Need Experts stress that it's more than post-pregnancy "baby blues" and needs treatment — in the form of therapy, antidepressants or other meds — to get better.
"Postpartum depression is a serious and potentially life-threatening condition in which women experience sadness, guilt, worthlessness — even, in severe cases, thoughts of harming themselves or their child," says Dr. Tiffany Farchione, director of the Division of Psychiatry in the FDA's Center for Drug Evaluation and Research. "And, because postpartum depression can disrupt the maternal-infant bond, it can also have consequences for the child's physical and emotional development."
Death by suicide accounts for about 20% of postpartum deaths, according to the CDC. They are a leading cause of maternal mortality in the U.S., where pregnancy-related deaths constitute a deepening crisis.
You can reach the Postpartum Support International helpline by calling or texting 800-944-4773. If you or someone you know is in crisis, please call, text or chat with the Suicide and Crisis Lifeline at 988, or contact the Crisis Text Line by texting TALK to 741741.
Shots - Health News Women Say California Insurer Makes It Too Hard To Get Drug For Postpartum Depression Possible causes of PPD include genetics and changing hormone levels after pregnancy. Risk factors include previous physical or sexual abuse, diabetes, complications during pregnancy and other life stressors (like dealing with grief or illness, being unemployed or having low income).
A family history of depression or previous mental health conditions can also increase a person's risk, though March of Dimes notes that for half of women diagnosed with PPD, it's their first time being diagnosed with depression.
Medical experts stress that PPD doesn't make someone a bad parent or person — and that they should contact their health care provider for help if their symptoms don't fade after two weeks (and immediately if experiencing suicidal thoughts).
This is the second FDA-approved treatment specifically for PPDSage Therapeutics is behind both of the PPD drugs to hit the market in recent years.
In 2019, the FDA approved the first of them: brexanalone, marketed as Zulresso.
That drug must be administered intravenously over the course of 60 hours — or 2 1/2 days — in a certified health care facility, with patients monitored consistently because of potentially serious side effects.
Health Patients are hopeful about a new pill approved to treat postpartum depression Patients are hopeful about a new pill approved to treat postpartum depression Listen · 4:02 4:02 Toggle more optionsEarly clinical studies showed that patients experienced a greater reduction of depressive symptoms (compared with a placebo) after 60 hours, and "generally still felt better" 30 days later.
There are plenty of other antidepressants that can be used to treat postpartum depression. But they work completely differently, and take effect more slowly.
For example, SSRIs — like Prozac or Zoloft — may take one to two months to become effective, Rutgers University nursing professor Jamille Nagtalon-Ramos told Morning Edition.
Mental Health Clinical trial leader on first FDA-approved pill for postpartum depressionDr. Kristina Deligiannidis, principal investigator on the Zurzuvae clinical trials, explains that this new drug is different — and faster — because it doesn't have to do with increasing serotonin levels.
"Zuranolone is a neuroactive steroid, and we believe that it's helping with stress management deep in the brain," she told All Things Considered. "We know that this is dysfunctional during pregnancy and postpartum for women who develop depression then. We think that that might be how it's working."
The clinical results are promising, though arguably limitedThe two studies off which the FDA based its approval show Zurzuvae to be effective at reducing symptoms of depression, with relatively minimal side effects — though some experts say they'd like to see more long-term data.
Participants in the trial were women with PPD whose symptoms began either in their third trimester or within four weeks of delivery. They either took a zuranolone product (including Zurzuvae itself) or a placebo, and compared the results.
1A The State Of Care For Perinatal And Postpartum Depression"[Participants] reported rapid antidepressant effects across the 14 days and as early as after two doses, so at day three. And then they continued to improve," Deligiannidis says. "And then we followed them all the way out to day 45. And what we saw is that improvement was sustained for many women."
The FDA says the treatment effect was still maintained at Day 42.
Though Nagtalon-Ramos, of Rutgers, who says she's concerned that the trial was completed in only 45 days. She points out that some definitions of postpartum cover the entire first year after having a baby (others break the postpartum phase down into three stages, the third lasting up to six months).
"And so I'm thinking about, after 45 days, what does that look like?" she asks. "Is there relapse or is there continued benefits after 45 days?"
FDA spokesperson April Grant told NPR in an email that the studies were designed to balance the need to assess how long the pill would be effective against the risk of delaying treatment.
The patients saw a "clinically meaningful benefit" during that 45-day window, Grant added, "with no trend suggesting loss of benefit" during the follow-up period.
Shots - Health News Maternal deaths in the U.S. Spiked in 2021, CDC reports The most common side effects of Zurzuvae include drowsiness, dizziness, diarrhea, fatigue, nasopharyngitis (the common cold) and urinary tract infection.
The FDA also says it may cause suicidal thoughts and behavior, but Deligiannidis says such labeling is required for all antidepressants and the researchers didn't see any such reports in their trials.
The label warns patients not to drive or operate heavy machinery for at least 12 hours after taking the pill — which it recommends doing in the evening with a fatty meal.
Deligiannidis says side effects observed in the study were "mild to moderate," and notes that it is a relatively short course of medication.
"So my hope is that any discomforts patients may have with the medication will be time-limited," she adds.
It's not clear how much the drug will costAnother issue of concern is the cost — and accessibility — of the pill. Drugmakers have delayed that decision until later this year, Axios reports.
Sage Therapeutics told investors on Monday that the company is committed to ensuring the drug remains accessible, with one of its goals being "that every woman with PPD who is prescribed Zurzuvae can access it, regardless of financial circumstance."
But details of how that will happen aren't yet clear.
Health When she was struggling with postpartum depression, 'co-mothering' saved her When she was struggling with postpartum depression, 'co-mothering' saved her Listen · 3:57 3:57 Toggle more options"We're eagerly awaiting, though we will have to wait some time to find out the cost of the treatment course and then also how insurers will cover this new medication," Deligiannidis explains.
Another complicating factor, Nagtalon-Ramos points out, is the changing health insurance coverage for the postpartum period itself.
For example, federal law requires states to provide pregnancy-related Medicaid coverage (which finances about 4 in 10 U.S. Births) through 60 days after a birth, but some people may lose it after that point.
Shots - Health News U.S. Maternal deaths keep rising. Here's who is most at risk The 2021 American Rescue Plan Act gives states the option to extend postpartum coverage to 12 months, which 36 states and D.C. Have so far (and 10 others plan to do).
"That is definitely something that we are concerned about," Nagtalon-Ramos says. "So having something that is available to all patients financially would be great."
It may not be right — or enough — for everyoneEven if the pill does become broadly accessible, medical experts warn that it may not be the best choice for all new moms.
Some may prefer talk therapy over a drug, while others who have been treated for depression in the past may choose to return to that same medication rather than try a new one, for example.
Consider This from NPR The Black Maternal Mortality Crisis and Why It Remains an Issue Plus, little is currently known about the effect of Zurzuvae in women who are breastfeeding, writes psychiatrist Dr. Ruta Nonacs with the Massachusetts General Hospital Center for Women's Mental Health.
She explains that participants in the clinical trials were asked to forgo breastfeeding while taking the drug, so there is no information available about the secretion of the drug into breast milk, any impact of the drug on breast milk production or the potential effects of zuranolone on nursing infants.
Shots - Health News Health department medical detectives find 84% of U.S. Maternal deaths are preventable "For many women, having to interrupt or avoid breastfeeding while receiving treatment for PPD may be a significant deterrent," Nonacs writes.
Other experts note that Zurzuvae might be part of a broader treatment plan that includes other resources, like certain types of therapy and lifestyle strategies — potentially to be continued after the dosage runs out.
"Postpartum time is a very difficult, challenging time for new parents," Deligiannidis acknowledges. "And if they do need additional treatments after day 14, then we have other things."
New: Cutting-edge Natural Bioactive Molecules Effectively Reduce Cold Symptoms
New York, August 10, 2023 – Researchers at Applied Biological Laboratories Inc. Discovered how natural bioactive molecules can effectively relieve cold and flu symptoms by protecting the mucosal barrier function and reducing inflammation during these infections. Together, they call these molecules, which include lysozyme and lactoferrin, the "Mucosal Immune Complex."
The research, led by Nazlie Sadeghi-Latefi, PhD, highlights the importance of supporting mucosal barrier immunity to prevent and treat colds and flu. This work will be presented at the American Chemical Society Fall 2023 Meeting on August 15, 2023.
Mucosal immunity is the body's first line of defense against invading pathogens, such as those causing the common cold and influenza. While the mucosal barrier functions primarily as a part of the innate immune response, it provides a crucial bridge to adaptive immunity. Once someone is infected, the mucosal immunity and barrier integrity determine the extent of the infection, and thus the illness severity and duration.
Popular cold & flu remedies may do more harm than good
A previous peer reviewed study by researchers at Applied Biological Laboratories compared the effects of natural bioactive molecules to those of the most popular over-the-counter cough and cold medications using in vitro respiratory mucosal barrier models. The researchers found that these popular OTC medications damage the mucosal barrier and increase inflammation (the underlying cause of cold symptoms), which they say may translate to possibly worsening symptoms, prolonging infections, and increasing the risk of secondary infections.
Smith Johnston, MD, clinical faculty at the University of Texas Medical Branch, former Medical Officer emeritus for NASA's Medical Operations Branch, and a member of Applied Biological Laboratories' scientific advisory board adds that decades of meta-analyses of clinical trials have found inconclusive evidence of safety and effectiveness for many popular over-the-counter common cold and flu medications. Although these medications often claim to provide the indicated symptomatic relief, they have not been shown to effectively reduce the severity and duration of illness better than placebo. Many of these were approved for over-the-counter (monograph) marketing before the FDA required rigorous clinical trials to approve over-the-counter drugs.
Lysozyme and Lactoferrin strengthen mucosal barrier immunity, block viral entry, and synergize with more specific COX inhibitors
One of the key inflammatory signals in respiratory inflammation and cold symptoms involves prostaglandin generation via COX enzymes. When low doses of plant-based acetylsalicylic acid (aspirin), or other naturally derived COX inhibitors such as aloe vera extract were combined with lysozyme, lactoferrin, and menthol the anti-inflammatory effects through inhibition of COX-mediated inflammation and bradykinin-mediated IL-8 were even greater than with the COX inhibitor alone. Thus, this combination of natural bioactive molecules has powerful synergistic effects for relieving cold and flu symptoms.
Unlike common OTC cold & flu remedies, which do not focus on inflammation at all, and which may damage the mucosal barrier, specific concentrations of natural bioactive ingredients like lactoferrin and lysozyme did not damage the mucosal barriers but strengthened it according to the previously mentioned peer reviewed study. According to numerous other peer reviewed studies, lactoferrin and lysozyme activate local innate immune cells, such as macrophages and dendritic cells and may also bind to viruses, preventing them from docking and infecting respiratory epithelial cells.
Clinical trial confirms the synergistic benefits of natural bioactive molecules with low-dose aspirin in treating cold & flu symptoms
To confirm their findings and test their formulations clinically, researchers at Applied Biological Laboratories conducted a randomized, double-blind placebo controlled multi-center study. Relief of sore throat, a measure of upper respiratory inflammation was assessed as the primary endpoint and reduction of other common cold symptoms such as nasal discharge and congestion, sneezing, sore/scratchy throat, cough, headache, malaise, and fever/chills, as assessed by the modified Jackson scores were measured as secondary endpoints. The trial assessed 179 participants who were randomly assigned to either placebo or one of three treatment groups each containing the mucosal immune complex and a mix of other anti-inflammatory ingredients.
By the second day of the study, the treatment groups had a significant reduction of up to 4.59 points in modified Jackson scores, whereas the placebo group did not demonstrate any improvement in any category of Jackson scores. The researchers conclude that formulas containing the mucosal immune complex are an effective treatment for alleviating cold and flu symptoms, including nasal congestion, discharge, sneezing, sore throat, cough, headache, malaise, and fever/chills.
Implications and Impact
The potential implications of these results are significant, given the vast number of people affected by the common cold and flu every season. Every year, an average household shops for over-the-counter medications 26 times a year, spending an average of $338. To date, few studies have evaluated the impact of these medications on mucosal barrier integrity, which can affect symptom severity and susceptibility to secondary infections. In addition, clinical evidence that demonstrates the safety and effectiveness of cold and flu remedies has been scarce, even in FDA-approved medications.
Conclusion and Contact Information
Applied Biological Laboratories Inc is a New York biotechnology company committed to researching, developing, manufacturing, and distributing scientifically validated natural products that strengthen the body's innate defenses. Biovanta is an OTC cold and flu remedy based upon research findings at Applied Biological Laboratories Inc, currently available at 28,000 pharmacies nationwide.
For further information about Biovanta and ongoing research, please contact Applied Biological Labs based at 760 Parkside Ave, Brooklyn, NY 11226 and krischall@appliedbioinc.Com.
References:
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