In the News

Study Shows Discontinuation Of Opioids And Improvement In Chronic Pain After Topical Analgesic Treatment

Naturopathic Treatments for Chronic Conditions Are Safe and Effective, According to Numerous Research Studies

Tesseract Medical Research Launches New Products at Natural Partners, Featuring New Patent-Pending Delivery Science

Traumatic brain injury causes intestinal damage, study shows

New Lyme disease tests could offer quicker, more accurate detection

Removing Chemical Used to Make Teflon-like Coatings Has Led to Fewer Low Birth Weights and Less Brain Damage

The Surprising Reason This Probiotic Company is Making Toothpaste

Study Shows Discontinuation Of Opioids And Improvement In Chronic Pain After Topical Analgesic Treatment

Clarity Science, a division of Safe Harbor Compliance and Clinical Services LLC, reports results of a subset of opioid-experienced patients from the Institutional Review Board (IRB)- approved Optimizing Patient Experience and Response to Topical Analgesics (OPERA) Study which evaluated patients with chronic pain who were treated with topical analgesics. Overall results, published today in the Journal of Postgraduate Medicine (http://dx.doi.org/10.1080/00325481.2018.1414551) show that approximately 50% of patients taking opioids and prescribed topical analgesics for their pain discontinued use of their opioid medication after 3- or 6-months of treatment. 

The FDA and the CDC have reported that the number of prescriptions for opioids and other controlled substances increased dramatically in recent years and deaths associated with opioids continues to grow, with most recent information reporting over 64,000 drug overdose deaths in 2016. Fifty-thousand (50,000) of these were attributed to opioids.

Long-term use of opioids can lead to tolerance and physical dependence with increased doses needed to achieve optimal pain control. Once patients have started on opioid treatment for 5 days, patients are at risk for continuing these medications long-term, and are not likely to discontinue opioids after they have received them for 90 days.

In recent years, addressing chronic pain and the approximately 100 million patients who it affects, concerns about the massive increase in opioid prescriptions and associated adverse events have contributed to renewed efforts to find alternative pain management options.

Study results for this subset of 121 chronic pain patients who were taking opioids at study enrollment showed that after treatment with topical analgesics, 49% of patients in the 3-month and 56% of patients in the 6-month group reported they had completely discontinued use of opioids. In addition, 30% of patients reported that they were no longer taking any pain medication. Concurrent medications decreased by 65% after 3 months, and 74% after 6 months and there were statistically significant decreases in pain severity and interference scores within both groups. Lastly, less than 2% of patients reported minimal side effects associated with the topical medication.

According to Jeffrey Gudin, the lead investigator of the study and the Director of Pain and Palliative Care at Englewood Hospital in New Jersey, "In addition to previous results showing that topical analgesics were associated with reductions of up to 60% in the use of concurrent pain medications, including oral opioid analgesics, we now have data reflecting discontinuation of opioids after being treated with this therapy for 3- and 6-months.  Especially in today's environment, identifying treatments other than opioids for clinicians to prescribe to their pain patients has become a priority."

In July 2017, the National Academies of Science, Engineering, and Medicine (NASEM) reviewed the history and evolving role of opioids to identify actions that clinicians and others can incorporate to respond to the opioid epidemic. They found that research on pain was poorly resourced and suggested that research include studies that emphasize available treatment, including topical analgesic creams. Further, they recommended that public and private payors develop reimbursement models for comprehensive pain management that increase coverage to encompass these alternative pharmacologic and other non-pharmacologic approaches.

According to Peter Hurwitz, President of Clarity and an author of the study notes, "We hope the results of this study empower the payors to re-evaluate how they address coverage of treatments for their patients experiencing chronic pain. We have heard in the past that there is not sufficient scientific evidence supporting the use of topical analgesics for the management of chronic pain. With the focus on reducing the number of patients being prescribed opioids, other available therapeutic options must be considered to allow their patient-members in pain to be properly treated and managed. We are continuing our research efforts to identify treatments that are safe and effective and that can also reduce long-term societal cost and downstream impact. The results of this study are a positive step in that direction." 

Topical medications lower the risk of systemic AEs and drug-drug interactions, have limited systemic absorption, offer simple dose determination, provide direct access to the target site, and are easy for patients to apply.

Original OPERA study results for the total study population of 631 were published in the Journal of Pain Research (October 2017).

About Clarity Science: 
Clarity Science's goal is to conduct scientifically rigorous research that advances innovation in science and ultimately helps healthcare professionals provide improved patient care. By improving existing treatment methodologies or identifying new ones, Clarity Science aspires to make a global positive impact on patient health and to improve the quality of life for patients and their families. Learn more at www.clarityscience.com

Naturopathic Treatments for Chronic Conditions Are Safe and Effective, According to Numerous Research Studies

Numerous research studies of naturopathic treatments for common chronic conditions have shown that naturopathic medicine is both safe and effective. This is according to the Institute for Natural Medicine (INM), which today released a new FAQ about the safety of naturopathic medicine, in partnership with the American Association of Naturopathic Physicians (AANP).

Naturopathic medicine emphasizes prevention and the self-healing process to treat each person holistically and improve health outcomes. Consumers evaluating whether naturopathic medicine is safe should be aware of the following:

1.    Numerous research studies of naturopathic treatments for common conditions such as heart disease, diabetes, chronic low back pain, and anxiety have shown that naturopathic medicine is both safe and effective.

2.    Licensed naturopathic doctors complete a rigorous, four-year, in-residence, science-based, post-graduate medical education consisting of 4,100 hours of coursework and clinical training at an accredited naturopathic medical school.

3.    Medical malpractice insurance rates for naturopathic doctors are among the lowest of any medical services provider.

4.    Few medical treatments are 100% safe, but some are safer than others.

"With 2.7 million serious adverse reactions to legally prescribed prescription drugs each year, Americans should be cautious when seeking medical treatments and providers," said Michelle Simon, PhD, ND and Chair of the INM Board of Directors. "Naturopathic doctors follow the Therapeutic Order, a set of guidelines for clinical decision making that offer the greatest benefit to the patient with the least potential for damage. This means that naturopathic doctors begin with minimally invasive therapies aimed at supporting the body, and recommend invasive treatments as a last resort."

The complete FAQ, "Is naturopathic medicine safe?" can be found here.

About the Institute for Natural Medicine
The Institute for Natural Medicine (INM) is a national not-for-profit 501(c)(3) organization that provides public education about naturopathic medicine and increases consumer access to naturopathic doctors. As a close partner to the American Association of Naturopathic Physicians, the INM strives to increase consumer and physician choice in safe, effective healthcare that improves patient outcomes and lowers costs. For more information visit www.naturemed.orgor call 855-799-4490.

About the AANP
The American Association of Naturopathic Physicians is the professional association that represents licensed naturopathic physicians. The AANP strives to make naturopathic medicine available to every American, and to increase recognition of naturopathic physicians as the identified authorities on natural medicine. Learn more at www.naturopathic.org.

Tesseract Medical Research Launches New Products at Natural Partners, Featuring New Patent-Pending Delivery Science

Natural Partners, Inc., a trusted resource for integrative health-care practitioners, is proud to feature the latest products from Tesseract Medical Research, TetraCumin SR™ and TetraCumin QR™.

TetraCumin-SR™ (sustained release) and TetraCumin-QR™ (quick release), are formulated using the proprietary CyLoc™ and DexKey™ delivery science. In addition to this patent-pending technology, these products contain the bioactive curcumin metabolite Tetrahydrocurcumin, the form of curcumin that the body is best able to absorb. As the only products on the supplement market to contain pure Tetrahydrocurcumin, TetraCumin SR™ and TetraCumin QR™ provide a more soluble, optimally bioavailable, and effective delivery of curcumin to the body.

"This new delivery science delivers what was previously believed to be impossible," said Al Czap, founder of Tesseract Medical Research. "The full bioavailability and potential of natural molecules can be completely unleashed and be available for optimal absorption by the body, even in patients with compromised systems."

Tesseract Medical Research, conceived and developed by industry leader Al Czap, Founder and former CEO of Thorne Research, provides extraordinary improvements in bioavailability, efficacy, and patient outcomes. In addition to TetraCumin SR™ and TetraCumin QR™ for musculoskeletal support, Tesseract Medical Research offers three additional products through Natural Partners, including ProButyrate™ for gastrointestinal health, AuRx™, a medical food for the nutritional support of Autism Spectrum Disorder, and QuerciSorb for immune function support.

The entire Tesseract Medical Research product suite is now available to health-care practitioners at naturalpartners.com.

Traumatic brain injury causes intestinal damage, study shows

University of Maryland School of Medicine (UMSOM) researchers have found a two-way link between traumatic brain injury (TBI) and intestinal changes. These interactions may contribute to increased infections in these patients, and may also worsen chronic brain damage.

This is the first study to find that TBI in mice can trigger delayed, long-term changes in the colon and that subsequent bacterial infections in the gastrointestinal system can increase posttraumatic brain inflammation and associated tissue loss. The findings were published recently in the journal Brain, Behavior, and Immunity.

"These results indicate strong two-way interactions between the brain and the gut that may help explain the increased incidence of systemic infections after brain trauma and allow new treatment approaches," said the lead researcher, Alan Faden, MD, the David S. Brown Professor in Trauma in the Departments of Anesthesiology, Anatomy & Neurobiology, Psychiatry, Neurology, and Neurosurgery at UMSOM, and director of the UMSOM Shock, Trauma and Anesthesiology Research Center.

Researchers have known for years that TBI has significant effects on the gastrointestinal tract, but until now, scientists have not recognized that brain trauma can make the colon more permeable, potentially allowing allow harmful microbes to migrate from the intestine to other areas of the body, causing infection.. People are 12 times more likely to die from blood poisoning after TBI, which is often caused by bacteria, and 2.5 times more likely to die of a digestive system problem, compared with those without such injury.

In this study, the researchers examined mice that received an experimental TBI. They found that the intestinal wall of the colon became more permeable after trauma, changes that were sustained over the following month.

It is not clear how TBI causes these gut changes. A key factor in the process may be enteric glial cells (EGCs), a class of cells that exist in the gut. These cells are similar to brain astroglial cells, and both types of glial cells are activated after TBI. After TBI, such activation is associated with brain inflammation that contributes to delayed tissue damage in the brain. Researchers don't know whether activation of ECGs after TBI contributes to intestinal injury or is instead an attempt to compensate for the injury.

The researchers also focused on the two-way nature of the process: how gut dysfunction may worsen brain inflammation and tissue loss after TBI. They infected the mice with Citrobacter rodentium, a species of bacteria that is the rodent equivalent of E. coli, which infects humans. In mice with a TBI who were infected with this the bacteria, brain inflammation worsened. Furthermore, in the hippocampus, a key region for memory, the mice who had TBI and were then infected lost more neurons than animals without infection.

This suggests that TBI may trigger a vicious cycle, in which brain injury causes gut dysfunction, which then has the potential to worsen the original brain injury. "These results really underscore the importance of bi-directional gut-brain communication on the long-term effects of TBI," said Dr. Faden.

Story Source: Materials provided by University of Maryland School of Medicine.

New Lyme disease tests could offer quicker, more accurate detection

New tests to detect early Lyme disease -- which is increasing beyond the summer months -could replace existing tests that often do not clearly identify the infection before health problems occur.

In an analysis published on December 7 in Clinical Infectious Diseases, scientists from Rutgers University, Harvard University, Yale University, National Institute of Allergy and Infectious Diseases of the NIH and other academic centers, industry and public health agencies say new diagnostic methods offer a better chance for more accurate detection of the infection from the Lyme bacteria.

"New tests are at hand that offer more accurate, less ambiguous test results that can yield actionable results in a timely fashion," said Steven Schutzer, a physician-scientist at Rutgers New Jersey Medical School and senior author. "Improved tests will allow for earlier diagnosis which should improve patient outcomes."

Lyme disease is the most common tick-borne infection in North America and Europe. There are currently over 300,000 cases of Lyme disease annually in the United States alone and the disease is increasing and spreading into new regions. Lyme disease frequently, but not always, presents with a bull's-eye rash. When the rash is absent, a laboratory test is needed.

The only FDA approved Lyme disease tests, based on technology developed more than two decades ago, rely on detecting antibodies that the body's immune system makes in response to the disease. These antibody-based tests are the most commonly used tests for Lyme disease and are the current standard.

One problem, however, is that many people produce similar -- called "cross-reactive" -- antibodies in response to other bacteria not associated with Lyme disease, which causes confusing results and makes test accuracy more difficult.

"New tests are more exact and are not as susceptible to the same false-positive or false-negative results associated with current tests," said Schutzer.

Schutzer and his colleagues say more accurate testing would help doctors decide when to prescribe the antibiotics used to clear the infection and help avoid severe long-term health problems. Antibody tests, can take three weeks or more for the antibody levels to reach a point where the tests can pick up a positive result.

Those involved in the paper joined forces after meeting at Cold Spring Harbor Laboratory's Banbury Center, a nonprofit research institution in New York. The meeting organized and chaired by Schutzer and John A. Branda, assistant professor of pathology at Harvard Medical School, focused on current Lyme disease tests and new scientific advances made in increasing the accuracy of the diagnosis.

"This meeting and paper resulting from it are particularly significant," said Jan Witkowski, professor in the Watson School of Biological Sciences at Cold Spring Harbor Laboratory who along with Nobel Laureate James Watson asked Schutzer to lead several symposia. "The participants noted that there are greatly improved diagnostic tests for Lyme disease that can be implemented now, and that the way is open to the development of further tests."

Story Source: Materials provided by Rutgers University. 

Removing Chemical Used to Make Teflon-like Coatings Has Led to Fewer Low Birth Weights and Less Brain Damage

Government and industry efforts since 2003 to phase out chemicals used to make non-stick coatings, such as Teflon, have prevented more than 118,000 low-weight births and related brain damage in the United States.

This is the main finding of a new report — based on analysis of new mothers' blood samples gathered for a national health study — published Nov. 23 in the International Journal of Hygiene and Environmental Health.

Scientists behind the research, conducted at NYU School of Medicine, say that studies have long linked the chemicals — famous for keeping food from sticking to pans — with high blood pressure, birth defects, and lower-than-normal birth weights. These damaging health effects were major factors behind a 2006 agreement between the Environmental Protection Agency (EPA) and American manufacturers to curtail and eventually eliminate the harmful chemicals' production in 2014.

The study authors estimate that the drop in chemically linked low-birth weight babies saved the nation at least $13.7 billion by reducing infant hospital stays and the number of children in need of long-term care after cognitive damage; and by improving the prospects of children going on to achieve higher education levels and get better-paying jobs.

"The evidence is overwhelming that the EPA-industry accord to phase out chemicals once used in nonstick coatings has been a major success in protecting children's health," says study lead investigator and health epidemiologist Leonardo Trasande, MD, MPP, an associate professor at NYU Langone Health. "This policy designed to lessen human exposure has spared thousands of newborns from damage to their health and saved U.S. taxpayers over a billion dollars in unnecessary health care costs."

Before 2006, the principal danger to fetuses and pregnant women, researchers say, came from chemicals used in the manufacture of the coating called perfluorooctanoic acid, or PFOA. Not occurring naturally in the environment, PFOA chemicals accumulate in the blood of marine mammals and in most humans exposed to them. Research over decades has linked even a nanogram (one-billionth of gram) increase in PFOA per milliliter of blood to an 18.9 gram reduction in birth weight.

A healthy newborn typically weighs about 8 pounds (3,600 grams), experts say, and a low birth weight —  associated with potential brain damage — is considered anything less than 5.5 pounds (2,500 grams).

Trasande cautions that while the EPA-industry accord has greatly diminished blood PFOA levels, products manufactured before the phase-out are still in circulation. He also says that the health impact for chemical replacements for PFOA, related chemicals called perfluorinated compounds (PFCs) remain unknown. Both sets of chemicals are endocrine disruptors, a set of chemicals shown by recent studies to interfere with natural hormone function, says Trasande.

Senior study investigator Teresa M. Attina, MD, PhD, also of NYU Langone, says the detrimental health effects seen with the original nonstick chemical formulation warrant more thorough safety testing of PFCs before any more of them receive government approval.

For the new study, funded entirely by NYU Langone, the research team looked for PFOA levels in blood analyses kept on participants in the National Health and Nutrition Examination Survey. Since 1999, NHANES, as it is known, has gathered information about the prevalence of and risk factors for major diseases by annually surveying 5,000 volunteers.

Survey results showed that blood PFOA levels in women of child-bearing age, from 18 to 49, continued to rise from 2003 to 2008, when median levels peaked at 3.5 nanograms per milliliter. But the trend, investigators say, reversed in 2009, a few years after the phase-out was introduced, and hazardous blood levels began dropping from a median 2.8 nanograms per milliliter to 1.6 nanograms per milliliter by 2014.

Computer models were then used to project the percentage of low-weight births that could have been prevented from specific PFOA chemical exposure and to calculate the estimated health costs and lost income. According to the team's analysis, the number of low-birth weight babies in the United States attributable to such PFOA exposure dropped from a highpoint of 17,501 in 2008 to 1,491 in 2014.

In addition to Trasande and Attina, other members of the NYU research team are Julia Malits and Jan Blustein.

The Surprising Reason This Probiotic Company is Making Toothpaste

Hyperbiotics harnesses the latest in microbial science with the release of new, probiotic-infused natural toothpaste.

Leader and pioneer in probiotic and prebiotic supplementation, Hyperbiotics adds a revolutionary natural probiotic toothpaste to its line of digestive and oral health solutions, called Activated Charcoal Probiotic Toothpaste.

Gut health advocate and Co-founder of Hyperbiotics, Jamie Morea, explains that new microbial science is leading the way forward, leaving traditional toothpastes behind.

“Your body is made up of good bacteria that keep you well. They live in your digestive tract, which begins in your mouth, and they’re currently under an all out assault by traditional oral care products,” explains Morea.

“The truth is that many toothpastes and oral hygiene products contain ingredients that indiscriminately destroy beneficial bacteria within the oral microbiome, which we now know can lead to more dental and overall health issues. What are our oral health products doing for us if they are leaving us less capable of having naturally healthy teeth and gums? We asked ourselves this question and then got to work formulating what we feel is the solution, Activated Charcoal Probiotic Toothpaste.”

Made with activated coconut charcoal, Dental-Lac™ (from L. paracasei), diatomaceous earth, organic coconut oil, and xylitol, Hyperbiotics Probiotic Activated Charcoal Toothpaste contains the perfect mix of ingredients for microbial support, effective cleaning, a brighter smile, and long-lasting good breath without any harmful or questionable additives.

Activated coconut charcoal gently and effectively whitens teeth without damaging or weakening enamel, xylitol is the natural enemy of undesirable bacteria, and the probiotic superstar L. paracasei has been clinically shown to promote the growth of beneficial bacteria in the mouth. The result? A healthier balance of oral bacteria to support optimal dental, oral, and whole-body health...and a dazzling smile.

Naturally flavored with spearmint and tea tree essential oils and safe enough to eat, Hyperbiotics Activated Charcoal Toothpaste is a smart, delicious choice for the whole family. This next-generation toothpaste is non-GMO, vegan, and free from Triclosan, glycerin, fluoride, SLS, foaming agents, harsh detergents, and artificial colors and flavors.

“Microbial research over the last 10 years has shown us that digestive probiotics are essential for nearly all aspects of overall health, and recent research has uncovered the importance of oral probiotics for dental, upper respiratory, and whole-body health. Our probiotic toothpaste is a simple, significant step forward that promotes a healthy smile and, more importantly, a healthy life,” concludes Morea.

Learn more about Hyperbiotics Activated Charcoal Probiotic Toothpaste:
https://www.hyperbiotics.com/products/activated-charcoal-probiotic-toothpaste