In the News

Study Finds Pycnogenol Effective in Improving Inner Ear Circulation with Relief of Symptoms of Meniere's Disease, Including Tinnitus

Study Identifies Molecular Key to Healthy Pregnancy

Brain Sodium Channels in Heart Linked to Sudden Cardiac Death

Personalized Medicine Coalition Sheds New Light on Progress and Challenges Facing the Development of Personalized Medicine

JAMA Pediatrics Reports Nurse-Family Partnership Reduces Preventable Death Among Mothers and Children

Vital Nutrients Exceeds Industry Standards in Recent FDA Inspection

Study Finds Pycnogenol Effective in Improving Inner Ear Circulation with Relief of Symptoms of Meniere's Disease, Including Tinnitus

A new study published in the June issue of the Minerva Medica found that supplementation with Pycnogenol (pic-noj-en-all), a natural antioxidant plant extract from French maritime pine tree bark, significantly improves inner-ear blood flow, making it a natural option for those seeking relief from symptoms of Meniere's disease such as dizziness, ringing in the ear, hearing loss, inner-ear pressure and unsteady balance. These chronic symptoms can affect quality of life and result in missed work days, falls and lead to depression. Researchers found that nearly 90 percent of patients were free of all inner-ear-related symptoms within six months of supplementing with Pycnogenol.

"More than 50 million Americans suffer from Meniere's disease and tinnitus, and because symptoms are often varied and inconsistent, these inner-ear issues are difficult to diagnose and treat," said Dr. Steven Lamm, a physician and nutritional medicine expert. "Building on previous research, this study suggests that Pycnogenol is a safe and natural option that may bring significant relief to those suffering from these conditions within a relatively short period of time."

In the study conducted at the Italian Chieti-Pescara University, researchers treated and monitored 107 patients between the ages of 35 and 55 who were diagnosed with Meniere's disease and suffering from symptoms like tinnitus. All patients were managed with best available management (BM) which included anticholinergics, benzodiazepines, antihistamines, corticosteroids, low salt diet and avoidance of caffeine, alcohol or other stimulants. In addition to BM treatments, the Pycnogenol group supplemented with 150mg/day of the patented pine bark extract. Results were recorded based on observational and reported scales for symptoms such as tinnitus, feeling of pressure and unsteady gait.

Inner-ear blood flow velocity was measured using a high-resolution, linear imaging probe. At baseline, flow velocity at the level of the affected ear was significantly lower in comparison with the other ear showing cochlear hypoperfusion.

There was more significant improvement in all registry items at both three and six months in the Pycnogenol group as compared to the control group. After six months of observation, nearly 90 percent (87.3 percent) of subjects in the Pycnogenol group were asymptomatic, as compared to just more than 34 percent (34.6 percent) in the control group.

Over the course of six months, researchers also found Pycnogenol to:

·         Significantly improve inner-ear blood flow and reduce pressure as compared to control group (higher flow, higher diastolic component (p<0.05))

·         Significantly improve patient-reported tinnitus as compared to control group (p<0.05 at three and six months)

·         Reduce the number of missed work days due to inner-ear ailments as compared to control group (p<0.05)

"The important effect of Pycnogenol on improving microcirculation makes it a safe and natural option for those seeking relief from the symptoms of Meniere's disease, including tinnitus," said Dr. Gianni Belcaro, lead researcher of the study. "Because Pycnogenol also has proven anti-inflammatory activity and antioxidant action, it may also help protect against the onset of tinnitus."

This study confirms previous findings from the catalog of research on tinnitus and inner-ear ailments including a 2010 study that found Pycnogenol to be effective to significantly relieve tinnitus symptoms by improving blood flow in the inner ear. To review the clinical research and additional information on Pycnogenol visit Pycnogenol.com.

SOURCE Pycnogenol

Study Identifies Molecular Key to Healthy Pregnancy

Scientists have identified a crucial molecular key to healthy embryo implantation and pregnancy in a study that may offer new clues about the medical challenges of infertility/subfertility, abnormal placentation, and placenta previa.

Multi-institutional teams led by researchers at Cincinnati Children's Hospital Medical Center reported their results in Cell Reports yesterday, July 17. The authors found that uterine expression of a gene called Wnt5a—a major signaling molecule in cell growth and movement in both embryo development and disease—is also critical to healthy embryo implantation in the uterus.

The scientists say that molecular signaling from Wnt5a—working in tandem with its co-receptors ROR1 and ROR2 in the uterus—causes uterine implantation chambers (crypts) in mice to form at regular intervals. The signaling also helps direct embryos to migrate in the proper direction as they settle into the womb. The authors show that disruption of appropriate uterine Wnt5a-ROR signaling leads to abnormal uterine luminal epithelial architecture, crypt formation, disorderly spacing of embryos, and implantation. These adverse effects led to defective decidualization, placentation, and ultimately compromised pregnancy outcome.

"Proper implantation is important to healthy pregnancy, and it is not clearly understood what prompts embryos to move and implant within a uterine crypt with regular spacing," said Sudhansu K. Dey, PhD, senior investigator and director of Division of Reproductive Sciences, Cincinnati Children's Hospital Medical Center. "If something goes wrong at this stage, there could be adverse effects throughout the course of pregnancy—whether it is subfertility, infertility, restricted growth, miscarriage, or preterm birth."

Although there are similarities and differences between mouse and human implantation, a role for Wnt5a-ROR signaling in embryo spacing could be clinically relevant, Dey said. This is because the embryo can sometimes implant close to or on the cervix (placenta previa), which can cause extensive bleeding and lead to increased mortality or morbidity for the mother and fetus. Aberrant embryo spacing may also contribute to complications in a multiple gestation pregnancy.

The current study is a continuation of the work Dey and his team published in 2011 in Developmental Cell. Also conducted in mice, this study showed two genes (Msx1 and Msx2, which play integral roles in organ formation during fetal development) are also essential to direct the uterus to the receptive stage for successful embryo implantation. In that study, Dey and colleagues found that Wnt5a signaling is disrupted when Msx is inactivated in the uterus. This suggests that Msx genes have a molecular relationship with Wnt5a. Subsequent studies by Dey and colleagues reported that Msx genes may be critical for successful implantation in other mammalian species.

Now that the researchers have identified Wnt5a and ROR as key regulators in embryo spacing and implantation, their next study focuses on the specific molecular and biochemical pathways (and related functions) regulated by Wnt5a-ROR signaling.

Jeeyeon Cha, an MD/PhD student in Dey's lab, is the first author on the Cell Reports Paper. Other co-authors include Amanda Bartos, Craig Park, Xiaofei Sun, and Yingju Li in Dey's lab; and Sang-Wook Cha in the Division of Developmental Biology. This study was conducted in collaboration with Rieko Ajima, National Institute of Genetics in Japan; Henry Ho, Department of Cell Biology and Human Anatomy, UC Davis; and Terry Yamaguchi, National Cancer Institute (National Institutes of Health).

Funding support for the study came in part from the National Institutes of Health, the March of Dimes, an individual National Research Service Award, and a Lalor Foundation Post-doctoral Fellowship.

Source: Cincinnati Children's Hospital Medical Center, cincinnatichildrens.org

Brain Sodium Channels in Heart Linked to Sudden Cardiac Death

A research study published in the July issue of Journal of the American College of Cardiology reports that genetic mutations in a neuronal sodium channel gene are associated with inherited sudden cardiac death syndromes, including the Brugada syndrome. The study, performed at the Cardiac Research Institute at Masonic Medical Research Laboratory (MMRL) in Utica, NY, included physicians and scientists from throughout the world who referred patients with life-threatening cardiac arrhythmias to the MMRL for genetic screening.

The Brugada syndrome is associated with an inherited irregular heart rhythm. In some cases, the first warning sign is sudden cardiac death. The syndrome affects approximately five in 10,000 individuals. The MMRL, one of the top genetic screening centers in the world devoted to inherited sudden cardiac death syndromes, identified the majority of genes responsible for the Brugada syndrome. The MMRL works with families who have tragically lost someone to this insidious disease, testing children, siblings, and other relatives to see if they are also at risk.

Prior to this discovery, a genetic defect could be identified in only 35 percent of Brugada syndrome patients. The new gene associated with the syndrome, called SCN10A, accounts for an additional 17 percent, thus greatly improving our ability to identify a susceptibility gene to more than 50 percent of affected index patients. SCN10A encodes a sodium channel previously thought to be associated exclusively with the brain and nervous system. This and other recent studies suggest that it is also present in the heart and when defective can result in life-threatening heart rhythm disorders.

Dr. Dan Hu, the lead author on this study, said these findings provide important insights into the pathophysiology of these syndromes as well as new targets for therapy. Dr. Charles Antzelevitch, Executive Director and Director of research of the MMRL, and senior author of the study, added, “The identification of SCN10A as a major susceptibility gene for Brugada syndrome greatly enhances our ability to identify patients and family members who are at risk. These findings also open the door to delineation of the role of other presumably neuronal sodium channels in the electrical function of the heart in both health and disease.”

Although a susceptibility gene can now be identified in more than 50 percent of affected index patients, that means that in nearly 50 percent the culprit gene remains unknown. “A negative study does not mean you don’t have the disease; it just means that the genetic marker cannot be identified,” said Antzelevitch. He added that “a great deal of research remains to be done to identify the other genes involved.”

Source: Masonic Medical Research Laboratory, mmrl.edu

Personalized Medicine Coalition Sheds New Light on Progress and Challenges Facing the Development of Personalized Medicine

According to a new report from the Personalized Medicine Coalition (PMC) released yesterday, members of the personalized medicine community are calling for critical changes in payment and coverage policies to encourage innovation and improve the quality of health care for millions of patients.

PMC's new white paper, "The Future of Coverage and Payment for Personalized Medicine Diagnostics," documents both the progress of personalized medicine and the ways in which some recent coverage and payment policies have discouraged its advancement.

"Over the past decade we've seen considerable growth in the scope and impact of personalized medicine, but we have far to go," said Amy Miller, PhD, executive vice president of PMC. "Comprehensive coverage and payment policies are necessary to encourage future investment in personalized medicine. As the paper shows, we have the opportunity to impact change, thus ensuring higher quality care and potentially lowering systemic costs if the right treatments are targeted to the right patients."

The report discusses three major public policy concerns:

>>Imminent Federal Pricing of Highly Innovative Molecular Tests: Between 2012 and 2014, there were multiple changes in the system for coding and pricing genomic tests, which shook the system of molecular diagnostic reimbursement, extending as far as a near suspension of federal payments for genomic tests in the first quarter of 2013. Even larger policy decisions will face the Centers for Medicare & Medicaid Services (CMS) in 2014 and 2015. PMC says that it is crucial that reimbursement levels—set unilaterally by policymakers—not only ensure access to high-quality tests, but also encourage the development of additional innovative tests based on substantial risk-based research and development.

>>Inconsistent Standards and Paradigms for Evaluating Diagnostic, Prognostic, and Predictive, Personalized Molecular Diagnostic Tests: Health technology assessments represent a rapidly growing area of international government policy, which has accelerated in the past several years as governments seek to contain costs. Although most agree that personalized molecular diagnostics improve patient management and the delivery of care, the report contends that assessments to determine coverage and payment are not clear, predictable, or appropriate, thus discouraging investment.

>>Lack of Incentives for Genomic Medicine: There are areas where genomic medicine could have a major impact on public health, but traditional funding, pricing, or reimbursement systems fail to provide enough incentive for its development. These areas include funding the education of physicians, allied professionals, and patients, as well as creating incentives to develop new tools that could revolutionize many therapeutic areas.

"Issues for personalized medicine are foreseeable and real," said Bruce Quinn, MD, PhD, principal report author and senior health policy advisor, Foley Hoag LLP. "We need to monitor, evaluate and contribute to the debate in these three areas to ensure personalized medicine is integrated into the development of Medicare policy in the years ahead. We need a reimbursement system that encourages the improvement of patient care through medical innovation. Patients expect no less."

The report also contrasts the public positions of the two most important federal agencies for the entry of personalized medicine into the healthcare system: FDA and CMS. In October 2013, the FDA released a cross-agency, 60-page document entitled, "Paving the Way for Personalized Medicine: FDA's Role in a New Era of Medical Product Development," which discusses FDA's initiatives to advance personalized medicine. Conversely, CMS' main public documents in 2013 focused on the cost-cutting proposals discussed in this white paper, without regard to either innovation or improving patient access to care.

A full list of PMC's publications, including the newly released "The Case for Personalized Medicine," are available here.

Source: Personalized Medicine Coalition, personalizedmedicinecoalition.org

JAMA Pediatrics Reports Nurse-Family Partnership Reduces Preventable Death Among Mothers and Children

A study published by JAMA Pediatrics – a leading, peer-reviewed journal of the American Medical Association – found that Nurse-Family Partnership (NFP) reduces preventable death among both low-income mothers and their first-born children living in disadvantaged, urban neighborhoods. This is the first randomized, clinical trial of an early intervention program conducted in a high-income country to find evidence of reductions in maternal and child death.

"Death among mothers and children in these age ranges in the United States general population is rare, but of enormous consequence. The high rates of death among mothers and children not receiving nurse-home visits reflect the toxic conditions faced by too many low-income parents and children in our society. The lower mortality rate found among nurse-visited mothers and children likely reflects the nurses' support of mothers' basic human drives to protect their children and themselves," said David Olds, PhD, professor of pediatrics at the University of Colorado and lead investigator on the study.

Beginning in 1990, this trial enrolled low-income, primarily African-American mothers living in disadvantaged neighborhoods in Memphis, Tenn., and assessed maternal and child mortality for over two decades until 2011. Olds will announce today these findings at a press conference at Le Bonheur Children's Hospital, which serves families through NFP in Memphis.

Nurse-Family Partnership produced a significant reduction in preventable child death from birth until age 20. Children in the control group not receiving nurse-home visits had a mortality rate of 1.6 percent for preventable causes – including sudden infant death syndrome, unintentional injuries and homicide. There were zero preventable deaths among nurse-visited children.

In addition, over the same two-decade period, mothers who received nurse-home visits had significantly lower rates of death for all causes compared to mothers not receiving nurse-home visits. Mothers in the control group who did not receive nurse-home visits were nearly three times more likely to die than were nurse-visited mothers. The relative reduction in maternal mortality was even greater for deaths due to external causes – those tied to maternal behaviors and environmental conditions – including unintentional injuries, suicide, drug overdose and homicide. Mothers not receiving nurse-home visits were eight times more likely to die of these causes than nurse-visited mothers.

"We intend to continue this research to see whether Nurse-Family Partnership reduces premature mortality at later ages and corresponding health problems as the mothers and children grow older," said Olds.

Earlier follow-up studies of the Memphis trial found that nurse-visited mothers, compared to those assigned to the control group, had better prenatal health and behavior; reduced rates of closely-spaced subsequent pregnancies; decreased use of welfare, Medicaid and food stamps; fewer behavioral impairments due to substance use; and fewer parenting attitudes that predispose them to abuse their children. At earlier phases of follow-up, nurse-visited children, compared to children not receiving nurse-home visits, were less likely to be hospitalized with injuries through age 2; less likely to have behavioral problems at school entry; and less likely to reveal depression, anxiety and substance use at age 12.

The Nurse-Family Partnership program is a national home visiting program for low-income women who are having their first babies. Each woman is paired with a nurse who provides her with home visits throughout her pregnancy until her child's second birthday. The program's main goals are to improve pregnancy outcomes, children's health and development and women's personal health and economic self-sufficiency.

This follow-up study of the Memphis trial is the most recent report from a series of randomized, clinical trials of the NFP program conducted over the past 37 years. Families in these trials are being followed over their life-course to estimate NFP's long-term effects. The Coalition for Evidence-Based Policy – a nonprofit, nonpartisan organization – has identified Nurse-Family Partnership as the only prenatal or early childhood program that meets its "Top Tier" evidence standard, which is used by the US Congress and the executive branch to distinguish research-proven programs.

In the United States, Nurse-Family Partnership currently serves over 29,000 women in 43 states, the US Virgin Islands and six tribal communities through the NFP National Service Office. In addition, NFP is implemented in six additional countries through the Prevention Research Center for Family and Child Health, directed by NFP founder David Olds.

SOURCE Nurse-Family Partnership

Vital Nutrients Exceeds Industry Standards in Recent FDA Inspection

Vital Nutrients recently received a flawless evaluation following a routine FDA Inspection. As always, the inspection was unannounced and comprehensive, reviewing all aspects of manufacturing and quality control from raw materials through finished products and all associated testing. This achievement reflects Vital Nutrients' persistent investment in maintaining the highest quality standards in the industry. Vital Nutrients is proud to provide supplements that practitioners can confidently prescribe to their patients.

Jessica Wilson, Marketing & Communications
Vital Nutrients
45 Kenneth Dooley Drive
Middletown, CT 06457