Past News Items - April 2014

A new study suggests that targeting B cells, which are a type of white blood cell in the immune system, may be associated with reduced disease activity for people with multiple sclerosis (MS). The study is released today and will be presented at the American Academy of Neurology's 66th Annual Meeting in Philadelphia, April 26 to May 3, 2014.

For the study, 231 people with relapsing-remitting MS received either a placebo or one of several low dosages of the drug ofatumumab, which is an anti-B cell antibody, for 24 weeks, with the first 12 weeks making up the placebo-controlled period. The main objective was to determine the effects of ofatumumab dosing regimens compared to placebo on the total number of new brain lesions assessed every four weeks over a 12-week period.

All dose groups including placebo showed lesion activity in the first four weeks with lesion suppression in all ofatumumab dose groups from weeks four to 12. Researchers measured the amount of B cells in participants and compared that to the total number of new brain lesions that appeared on brain scans, which is a marker of disease activity.

The researchers found that when B cells were reduced to below a threshold of 64 cells per microliter, disease activity, as measured by appearance of new brain lesions, was significantly reduced. On average, participants had an annualized rate of less than one new brain lesion per year when B cells were maintained below a threshold of 32 to 64 cells per microliter, compared with 16 lesions without treatment.

The most common side effects, defined as those occurring in at least five percent of participants and at a rate twice that of placebo for weeks zero to12, were injection-related reaction, dizziness, anxiety, fever, respiratory tract infection and nerve pain.

Study author Daren Austin, PhD, of GlaxoSmithKline in Uxbridge, United Kingdom, and a member of the American Academy of Neurology, said the study results also suggest that peripheral, rather than central, B cells may be the most relevant target for anti-B cell therapy.

"These results need to be validated, of course, but the findings are interesting," Austin said. "They provide new insight into the mechanism of B cells in MS and present a possible new target threshold for exploring the potential benefit of anti-B cell therapy."

Ofatumumab is not approved anywhere in the world for use in the treatment of multiple scelorosis.

SOURCE American Academy of Neurology

Released: 04/23/14

New Prostate Cancer Blood Test Now Available in the US

Beckman Coulter Diagnostics, a global leader in prostate cancer diagnostics, announces national availability of the Prostate Health Index (phi)*, a simple, non-invasive blood test that is three times more specific in detecting prostate cancer1 than PSA (prostate-specific antigen). The new test's accuracy decreases the need for many men who test positive for elevated PSA levels to undergo a biopsy in order to achieve a reliable diagnosis.

The most widely used screening test for prostate cancer is currently the PSA test, which measures the blood's level of PSA—a protein that is naturally produced by the prostate gland and is typically increased when cancer is present. However, it is widely recognized that PSA results can often indicate the possibility of prostate cancer when none is present.

"The PSA test is based on the fact that men with higher levels of the PSA protein are more likely to have prostate cancer," said William Catalona, MD, principal investigator on the Prostate Health Index clinical study and urologist at Northwestern Medicine and director of the Clinical Prostate Cancer Program at the Robert H. Lurie Comprehensive Cancer Center of Northwestern University, where they began using the phi test on patients in February. Dr. Catalona, who was the first physician in the U.S. to run the phi test, added, "However, the problem is that higher levels of PSA can also be caused by a benign enlargement or inflammation of the prostate, leading to many false-positives for cancer and ultimately unnecessarily invasive biopsies and an increased potential for patient harm."

The substantial increase in accuracy of the phi test over PSA addresses this concern. Results of a multi-center clinical study found a 31 percent reduction in unnecessary biopsies due to false-positives as a result of using the phi test.

"The phi test helps physicians distinguish prostate cancer from benign conditions by utilizing three different PSA markers (PSA, freePSA and p2PSA) as part of a sophisticated algorithm to more reliably determine the probability of cancer in patients with elevated PSA levels," said Kevin Slawin, MD, director, Vanguard Urologic Institute at Memorial Hermann Medical Group, clinical professor of Urology at Baylor College of Medicine and director of Urology, Memorial Hermann Hospital-Texas Medical Center, who performed some of the key research that led to the development of the phi test and who also began using the test in February. "We have seen first-hand how phi is much more accurate and reduces the need for prostate biopsies. And, the fact that phi is a simple blood test has been very appealing to our patients."

The phi test is now available to physicians nationwide through Innovative Diagnostics Laboratory (IDL), a national clinical reference laboratory specializing in personalized blood-based testing to find, understand and treat cancer.

"The phi test is a true advancement in the science of prostate cancer management and we are excited to be the first laboratory to offer this test to physicians throughout the US," said Tonya Mallory, CEO, president and co-founder of Innovative Diagnostics Laboratory. "The Prostate Health Index is a significant addition to our comprehensive menu of advanced clinical evidence-based blood tests that aid in early cancer detection."

"After years of collaboration with some of the world's leading prostate cancer researchers and medical institutions who have studied the scientific and clinical benefits of phi, we are pleased that the test is now available to help physicians and patients with an elevated PSA test result, more accurately detect prostate cancer," said John Blackwood, senior vice president, Chemistry/Immunoassay Business Unit, Beckman Coulter Diagnostics.

For information on phi and how to order the test, visit: prostatehealthindex.us

SOURCE Beckman Coulter

Released: 04/23/14

Study Examines Risk of Early Death for People with Mild Cognitive Impairment

One of the first studies to look at a relationship between death and the two types of mild cognitive impairment (MCI), or problems with memory and thinking abilities, suggests that people who have thinking problems but their memory is still intact might have a higher death rate in a period of six years compared to those who have no thinking or memory problems. The research was released today and will be presented at the American Academy of Neurology's 66th Annual Meeting in Philadelphia, April 26 to May 3. The same was suggested in the study for those who are experiencing MCI with memory decline; however the first group had the highest death rate.

MCI is often a precursor to Alzheimer's disease. There are two main types of MCI. In one type, the most noticeable symptom is memory loss. In people with the other type, language, attention, decision-making and other abilities are declining, but memory is still intact.

"Currently there is little information about death and the types of memory loss that affect many millions of Americans," said study author Maria Vassilaki, MD, with the Mayo Clinic in Rochester, Minn. "Exploring how memory may or may not be linked with the length of life a person has is of tremendous significance as the population ages."

For the study, 862 people with thinking problems and 1,292 with no thinking problems between the ages of 70 and 89 were followed for nearly six years. Participants were from Olmsted County, Minn., and were given tests at the start of the study and every 15 months to assess their thinking abilities.

Over six years, 331 of the group with MCI and 224 of the group without MCI died. Those who had either type of MCI had an 80 percent higher death rate during the study than those without MCI.

People with MCI with no memory loss had more than twice the death rate during the study than those without MCI, while people with MCI with memory loss had a 68 percent higher death rate during the study than those without MCI.

"We will continue to study the how and why regarding the relationship between memory decline, thinking decline and death. This research brings us one step at a time closer to the answers." said Vassilaki.

The study was supported by a grant from the National Institute on Aging.

Learn more about brain health at aan.com/patients.

Released: 04/22/14

Douglas Laboratories Launches Optimized Curcumin With Neurophenol

Douglas Laboratories, the trusted choice of healthcare professionals for superior quality, science-based nutritional supplements for more than 50 years, is proud to announce the addition of Optimized Curcumin With Neurophenol to its existing product line. Developed to support cognitive function and healthy aging of the brain in healthy older adults, the formulation utilizes proprietary technology to enhance curcumin absorption.

“We are pleased to provide healthcare professionals with a clinically supported, bioavailable curcumin that yields detectable and measurable levels of free curcumin in the blood.” said Andrew Halpner PhD, Vice President, Product Development and Technical Services at Douglas Laboratories. “We feel the combination of the Longvida Curcumin together with the flavonoids present in the grape and blueberry extracts of Neurophenol results in quite a unique product.”†

Free curcumin, rather than its conjugated metabolites (such as glucuronide), appears to be required in order for this important compound to gain entry into tissues including the brain. † Longvida Optimized Curcumin, based on patent pending discoveries from UCLA, uses patented Solid Lipid Curcumin Particle (SLCP) technology to achieve enhanced bioavailability and a longer half-life compared with typical curcuminoid products.

Longvidaalso has an emerging body of data to support its role in cognitive health, including placebo-controlled clinical trials that concluded significant benefits observed within 30 days at a dose of 400 mg daily.

Neurophenol™, a proprietary polyphenol-containing blend of blueberry and grape extracts is standardized to a unique flavonoid profile consisting of monomers, oligomers, flavonols, anthocyanidins and phenolic acids. Preclinical data support a role of Neurophenol in cognitive function and an ongoing placebo-controlled, double blind study is currently investigating its impact in healthy aging adults

Douglas Laboratories will host an educational webinar for healthcare professionals, on April 23, 2014, titled “Curcumin Advancements: The Aging Brain with Longvida Curcumin” with Blake Ebersole of Verdure Sciences. To register for the webinar, or for further information on the Douglas Laboratories Optimized Curcumin With Neurophenol formula, please visit douglaslabs.com.

Released: 04/21/14

Maryland Governor Signs Bill to License Naturopathic Doctors

Governor Martin O’Malley recently signed a bill to enable naturopathic doctors in Maryland to become licensed to practice naturopathic medicine. Maryland becomes the 18th state to license naturopathic doctors. Passage of the law reflects the public’s growing confidence in naturopathic medicine as an effective form of medicine.

Passage of the bill, which received strong bipartisan support, culminates four years of effort by naturopathic doctors in Maryland to gain licensure. After opposing licensure for four years, the Medical Society representing Maryland physicians dropped its opposition, largely because a growing number of MDs who strongly supported the bill. Aiding the naturopathic doctors’ efforts was support from the Maryland Department of Health and Mental Hygiene and Dr. Peter Beilenson, the former Commissioner of the Baltimore and Howard County health departments, and current President and CEO of the Evergreen Healthcare Co-Op.

According to Dr. Emily Telfair, president of the Maryland Association of Naturopathic Physicians, “The law will lead to greater access for Marylanders to doctors who emphasize disease prevention, healthy lifestyles, and natural therapies. It will also enable consumers to distinguish between licensed doctors who meet extensive education and training requirements and others who call themselves naturopaths but do not meet the state’s rigorous licensing standards.”

A turning point in the licensure effort came when Maryland’s Health Secretary, Dr. Joshua Sharfstein, and leaders from the Maryland General Assembly visited the Casey Health Institute in Gaithersburg, Maryland. The policy makers were impressed by the patient-centered, integrative approaches being used there to treat patients.

“The new law continues the movement to bring emerging professions such as naturopathic medicine into the medical mainstream,” commented Jud Richland, CEO of the American Association of Naturopathic Physicians. “Patients are increasingly demanding the kind of whole-person care delivered by naturopathic doctors. One by one, states are enacting laws to license highly skilled naturopathic doctors so that citizens have access to the kind of care that so many Americans are seeking.”

To become licensed in Maryland, a naturopathic doctor must attend a four-year naturopathic medical school that is accredited through the US Department of Education. Accredited naturopathic medical schools train naturopathic doctors in the same basic sciences as MDs. They also provide training in holistic and nontoxic approaches to preventing disease, optimizing wellness, and treating various health conditions. The doctor must then pass a rigorous professional licensing exam.

Released: 04/17/14

ACR: NEJM Article on Ending Breast Cancer Screening Programs Incomplete and Should Concern American Women

The American College of Radiology (ACR) and Society of Breast Imaging (SBI) agree with statements by Andorno and Jüni, in their recent article published in the New England Journal of Medicine (NEJM), that women need clear information with which to discuss mammography with their doctor. Unfortunately, the NEJM article failed to meet this standard. The authors minimized the deadly consequences of their recommendations to the Swiss government. The disastrous results may take years to develop. If breast cancer screening were ended in this country, it would cost the lives of up to 20,000 American women each year. The lack of a counterbalancing perspective, in a major scientific journal, is surprising and concerning. American women should pay close attention to the breast cancer screening policies that may be considered for them.

If routine breast cancer screening of all women were ended in the United States, approximately 15,000 – 20,000 additional women each year would die from breast cancer. Thousands more would endure extensive and expensive treatments than if their cancers were found early by a mammogram. Restriction of current screening would also cost lives. In 2009, the United States Preventive Services Task Force (USPSTF) suggested that women ages 40-49 not receive routine annual screening and those 50-74 receive biennial screening. Analysis (Hendrick and Helvie), published in the American Journal of Roentgenology, using the Task Force's own methodology, showed that if these USPSTF guidelines were followed, approximately 6,500 additional women each year in the U.S. would die from breast cancer.

The NEJM authors' claim that mammography does not save many lives through early detection of tumors is false. According to National Cancer Institute data, since mammography screening became widespread in the mid-1980s, the US breast cancer death rate, unchanged for the previous 50 years, has dropped well over 30 percent. Recent randomized control trials, particularly the largest (Hellquist et al) and longest running (Tabar et al) breast cancer screening studies in history respectively, have reconfirmed that regular mammography screening cut breast cancer deaths by roughly a third (not the 20 percent cited by Andorno and Jüni) in all women ages 40 and over — including women ages 40–49. A study (Otto et al) published in Cancer Epidemiology, Biomarkers & Prevention shows mammography screening cuts the risk of dying from breast cancer nearly in half. A recent study published in Cancer showed that more than 70 percent of women diagnosed with breast cancer in their 40s at major Harvard teaching hospitals were among the 20 percent of women who were not being screened. When discussing doing away with screening programs that have been proven to save thousands of lives each year, this information is critical.

The NEJM authors point to the Canadian National Breast Screening Study (CNBSS) to support claims of overdiganosis and lack of mammography effectiveness. Balanced information that the CNBSS has been widely discredited is not included. The World Health Organization long ago excluded the CNBSS from its analyses of screening mammography's impact of breast cancer mortality. In a recent interview with CNN, the American Cancer Society echoed methodological concerns about the study. Breast cancer groups, such as BreastCancer.org, have also criticized this study and warned against following the author's recommendations.

Medical science, at present, cannot determine which cancers will advance to kill a woman and which will not. As recently covered in the New York Times, estimates of overdiagnosis or overtreatment are not based on data regarding real patients, but are guesses based on population data that may be wildly off-mark. A recent article published in The Oncologist shows that many studies regarding overdiagnosis and potential harms of mammography are not well-founded and that their conclusions cannot be taken as fact. Yet, the NEJM authors advocate that widespread screening programs be ended, which would result in thousands of unnecessary deaths each year, based on such guesses. The ACR and SBI cannot support such a step.

Every major American medical organization with expertise in breast cancer care, including the American Congress of Obstetricians and Gynecologists , American Cancer Society, American College of Radiology, National Accreditation Program for Breast Centers and Society of Breast Imaging recommend that women start getting annual mammograms at age 40. The ACR and SBI continue to stand by these recommendations.

Mammography can detect cancer early when it's most treatable and can be treated less invasively — which not only save lives, but helps preserve quality of life. For more information regarding the proven effectiveness of regular mammography screening at reducing breast cancer deaths, please visit MammographySavesLives.org.

SOURCE American College of Radiology

Released: 04/17/14

UC Irvine Health Provides the Only Pediatric Pain Doctor in Southern California Treating Chronic Pain in Children

Shalini Shah MD, director of pediatric pain management in the UC Irvine Health Department of Anesthesiology and Perioperative Care, is the only specialist in Southern California fellowship-trained to treat children suffering from chronic pain.

Shah provides much needed relief to children facing cancer in need of interventional pain treatment and palliative care at the integrative clinic based in the UC Irvine Health Chao Family Comprehensive Cancer, where she also treats adults. This highly-specialized method of treating chronic pain in children began at Harvard University and Boston Children's Hospital where Shah completed a fellowship under Dr. Charles Berde, renowned as the father of pediatric pain management. Today, Shah brings this expertise to patients in Orange County and the surrounding community in Southern California. Dr. Shah is certified by the American Board of Anesthesiology in both anesthesiology and pain medicine.

"Every day, I care for children who come to me in debilitating pain and together we develop a treatment plan to alleviate that pain," said Shah, an assistant clinical professor of anesthesiology and pain medicine with UC Irvine Health. "It's rewarding to see these children brighten up and begin to laugh, play and just be a kid again. In many cases, parents have been to specialist after specialist and they are grateful for the outcomes that we achieve for their children."

As part of her work on pain in children and adolescents at the UC Irvine Health Center for Pain Management, Shah offers a scientific and holistic approach to pain care. This approach includes treatments for lower back pain, headaches, and joint pain to more complicated treatments such as spinal cord stimulation, intrathecal pain pump technology, cooled radiofrequency technology and botox. The pain center offers state-of-the-art technologies to treat low back pain, including, Cooled Radio Frequency Neuromodulation. UC Irvine is one of the first locations in Orange County to offer this innovative technology. Shah and her colleagues at the pain center focus on healing chronic pain at its source and is a firm believer in acupuncture, Reiki, and other integrative treatments.

In addition to her contributions to UC Irvine, Shah has authored numerous textbook chapters, and is a book reviewer for the Oxford Textbook of Pediatric Pain. She's a primary investigator for a clinical trial in pediatric pain management. With a particular interest in alleviating chronic pain conditions via a multi-disciplinary and interventional approach, Shah's aim is to reduce pain so children can reclaim their lives and return to the activities they enjoyed before the onset of pain.

SOURCE UC Irvine Health Department of Anesthesiology & Perioperative Care

Released: 04/16/14

Clinical Trial to Test Modified Citrus Pectin in Prostate Cancer

A phase III clinical trial conducted at the Meir Medical Center in Kfar-Saba, Israel is now recruiting participants to study the effects of dietary supplement PectaSol-C modified citrus pectin (MCP) in controlling prostate specific antigen (PSA) levels in prostate cancer patients.

"MCP has shown activity against prostate and other cancers in a number of previous studies, and toxicology reports show it to be extremely safe," says lead investigator Daniel Keizman, MD, Genitourinary Oncology Service, Institute of Oncology, Meir Medical Center. "We are further investigating whether MCP can help patients who are experiencing biochemical relapse of prostate cancer. Unfortunately, there is no standard treatment for these men."

With the exception of non-melanoma skin cancer, prostate cancer is the most common cancer among men, as well as their second leading cause of cancer-related death. Approximately 33 percent of prostate cancer patients previously treated with surgery and/or radiation experience biochemical relapse, the serial increase in PSA levels without evidence of metastasis.

The phase III clinical trial titled, "The Effect of Modified Citrus Pectin on PSA Kinetics in Biochemical Relapsed PC Patients with Serial Increases in PSA," seeks to determine whether MCP is an effective option for these patients. A natural dietary supplement, MCP is a specialized form of citrus pectin which is modified to a specific molecular weight and structure for absorption into the circulation and increased bioactivity. MCP has been shown to inhibit the inflammatory protein galectin-3, which is associated with cancer aggressiveness, chronic inflammation and fibrosis.

MCP has demonstrated anticancer activity in both preclinical and clinical studies, reducing tumor growth and metastasis; accelerating apoptosis of cancer cells, and selectively promoting immune activity and efficacy.

Specifically, MCP has been shown to inhibit prostate, breast and colon cancer, as well as melanoma in preclinical models. In previous clinical trials, MCP slowed down the PSA doubling times in men with aggressive prostate cancer. In addition, MCP has been shown in preclinical studies to work synergistically with chemotherapies such as doxorubicin and paclitaxel, maximizing their impact against cancer. MCP is also clinically proven in multiple human trials and case study reports to bind and eliminate heavy metals such as lead, mercury and arsenic from the circulation, without affecting essential mineral levels.

For this clinical study, researchers seek to recruit 60 prostate cancer patients who have received treatment and have shown increased PSA levels, but have no evidence of metastasis. This open label study will administer 4.8 grams of PectaSol-C MCP three times a day for six months. Patients will receive a clinical follow-up four months later. Full study details and inclusion criteria for participation can be found here on the cinicaltrials.gov website.

"Because of its ability to bind galectin-3, MCP has shown promise against a number of cancers," says Dr. Keizman. "This phase III trial will hopefully expand our understanding of MCP's potential to help prostate cancer patients faced with biochemical relapse."

If you are experiencing biochemical relapse from prostate cancer and are interested in participating in this phase III clinical trial, please contact Sharon Berkley at sharon.berkley@clalit.org.il or by phone at 972 (0)9 747 2101. For more information, visit the trial page at clincialtrials.gov.

SOURCE: Genitourinary Oncology Service, Institute of Oncology, Meir Medical Center

Released: 04/11/14

Primate Study Affirms: The CR Way Lifestyle Can Extend Life and Protect Against Age-related Disease

On April 1, primate researchers from the University of Wisconsin published a paper, affirming that caloric restriction (CR) without malnutrition significantly improves age-related and all-cause survival in rhesus monkeys. The researchers point out that their data contrasts with findings in the widely reported 2012 National Institutes of Aging study, where CR was not seen to show a significant survival benefit.

However, they emphasize an important point: The NIA control monkeys were effectively practicing modest calorie restriction because their food allotments were so well controlled.

The results from the Wisconsin study support findings from a study of elderly Okinawans who followed calorie restriction for 60 years, limiting calories by only 11 percent: Their average lifespan is the longest recorded in the world. They also experience less heart disease, cancer, diabetes, and Alzheimer's disease. Their quality of life is better too: Many Okinawans who practice calorie restriction remain active well into their nineties and beyond.

"We see similar results," says Paul McGlothin, president of LivingTheCRWay.com, where thousands practice calorie restriction. "The CR Way encourages moderate calorie restriction, which improves quality of life and is easy to follow.

"I find it interesting that five monkeys in the NIA study – four calorie-restricted and one control monkey – did live exceptionally long lives: beyond 40 years of age, when the average age of death of monkeys in captivity is 26.

"A CR Way lifestyle has produced supercentenarians – such as the famed Jiroemon Kimura, who ate three small meals a day and is verified as the longest-lived man in history."

Living the CR Way puts solid science to work to help you achieve extraordinary health in a friendly, holistic community where delicious meals and live, caring support are important. These are the objectives of the lifestyle:

Use calorie restriction science in health decisions: This often means not limiting calories if your BMI is below 24 or gaining weight if it is below 18.5.
Preserve adult stem cell health and activate your tissue repair capabilities.
Maintain DNA Stability.
Optimize your microbiome, i.e., the microbes in your gut (an emerging science).
Integrate your personal genomics into a lifestyle that fits your needs.
Develop a close relationship with a physician.

SOURCE Living the CR Way

Released: 04/09/14

Four Paraplegic Men Voluntarily Move Their Legs, an "Unprecedented Breakthrough" for Paralysis Community

Four young men who have been paralyzed for years achieved groundbreaking progress – moving their legs – as a result of epidural electrical stimulation of the spinal cord, an international team of life scientists at the University of Louisville, UCLA and the Pavlov Institute of Physiology reported today in the medical journal Brain. The study was funded in part by the Christopher & Dana Reeve Foundation and the National Institutes of Health.

All four participants were classified with a chronic motor complete spinal cord injury and were unable to move their lower extremities prior to the implantation of an epidural stimulator. This research builds on an initial study, published in the May 2011 edition of The Lancet, which evaluated the effects of epidural stimulation in the first participant, Rob Summers, who recovered a number of motor functions as a result of the intervention.

Now three years later, the key findings documented in Brain detail the impact of epidural stimulation in four participants, including new tests conducted on Summers. What is truly revolutionary is that the second, third and fourth participants were able to execute voluntary movements immediately following the implantation and activation of the stimulator. The results and recovery time were unexpected, leading researchers to speculate that some pathways may be intact post-injury and therefore able to facilitate voluntary movements.

"Two of the four subjects were diagnosed as motor and sensory complete injured with no chance of recovery at all," Claudia Angeli, PhD, senior researcher, Human Locomotor Research Center at Frazier Rehab Institute, and assistant professor, University of Louisville's Kentucky Spinal Cord Injury Research Center (KSCIRC) and lead author. "Because of epidural stimulation, they can now voluntarily move their hips, ankles and toes. This is groundbreaking for the entire field and offers a new outlook that the spinal cord, even after a severe injury, has great potential for functional recovery."

These results were achieved through continual direct epidural electrical stimulation of the participants' lower spinal cords, mimicking signals the brain normally transmits to initiate movement. Once the signal was triggered, the spinal cord reengaged its neural network to control and direct muscle movements. When coupling the intervention with rehabilitative therapy, the impact of epidural stimulation intensified. Over the course of the study, the researchers noted that the participants were able to activate movements with less stimulation, demonstrating the ability of the spinal network to learn and improve nerve functions.

"We have uncovered a fundamentally new intervention strategy that can dramatically affect recovery of voluntary movement in individuals with complete paralysis even years after injury," said Susan Harkema, PhD, University of Louisville professor and rehabilitation research director at KSCIRC, Frazier Rehab Institute, director of the Reeve Foundation's NeuroRecovery Network and primary author of The Lancet article. "The belief that no recovery is possible and complete paralysis is permanent has been challenged."

Beyond regaining voluntary movement, the research participants have displayed a myriad of improvements in their overall health, including the increase of muscle mass and regulation of their blood pressure, as well as reduced fatigue and transformational changes to their sense of well-being. Additionally, all four men were able to bear weight independently, as reported by the team, which also includes Yury Gerasimenko, PhD, professor and director of the laboratory of movement physiology at St. Petersburg's Pavlov Institute and a researcher in UCLA's Department of Integrative Biology and Physiology.

"This research brings up an amazing number of possibilities for how we can develop interventions that will help people recover movement they have lost," said V. Reggie Edgerton, PhD, UCLA distinguished professor of integrative biology, physiology, neurobiology and neurosurgery. "The circuitry in the spinal cord is remarkably resilient. Once you get them up and active, many physiological systems that are intricately connected and were dormant come back into play."

Providing Hope for People Living with Paralysis

With nearly six million Americans living with paralysis, including 1.275 million spinal cord injuries, this study confirms a significant breakthrough in terms of developing clinical therapies to advance the treatment of paralysis. The participants ranged in neurological level from C7-T5 and were at least two years post–injury at the time of the intervention. The initial research hypothesis stated that the two participants with the American Spinal Injury Association Impairment Scale (AIS) classification of AIS A would not elicit any voluntary movement, despite the therapy intervention, and the two participants who were AIS B would develop voluntary movement following a combination of training and epidural stimulation. However, in the presence of epidural stimulation, all four recovered voluntary control of their lower extremities, surprising researchers who believed at least some of the sensory pathway must be intact for epidural stimulation to be successful.

As the first epidural stimulation participant, Rob Summers moved the needle for the entire field with his unprecedented recovery. With a C6 injury, he was paralyzed below the chest after being struck by a vehicle in 2006. Summers currently resides in Portland, Oregon. The other three research participants include:

Kent Stephenson was the second person to undergo epidural stimulation after sustaining an injury at T5-T6 during a motocross accident in 2009. He resides in Mount Pleasant, Texas.
Andrew Meas was in a motorcycle accident in 2007, resulting in an injury at C6-C7. Meas was the third person implanted and lives in Louisville, Kentucky.
Dustin Shillcox injured his spine at T5 in a devastating auto accident in 2010. He was the fourth participant and resides in Green River, Wyoming.

"With this study the investigators show that their findings about a motor complete patient regaining movement, as published three years ago in The Lancet, were not an anomaly," said Susan Howley, executive vice president for research at the Christopher & Dana Reeve Foundation. "At the present time, other than standard medical care, there are no effective evidence-based treatments for chronic spinal cord injury. However, the implications of this study for the entire field are quite profound and we can now envision a day where epidural stimulation might be part of a cocktail of therapies used to treat paralysis."

Investing in Epidural Stimulation

The research was funded by the Christopher & Dana Reeve Foundation, the National Institutes of Health (RO1EB007615, P30 GM103507), the Leona M. and Harry B. Helmsley Charitable Trust, the Kessler Foundation, the University of Louisville Foundation, Jewish Hospital and St. Mary's Foundation, Frazier Rehab Institute and University of Louisville Hospital.

"When we first learned that a patient had regained voluntary control as a result of the therapy, we were cautiously optimistic," said Roderic Pettigrew, MD, PhD, director of the National Institute of Biomedical Imaging and Bioengineering, which provided support for the study. "Now that spinal stimulation has been successful in four out of four patients, there is evidence to suggest a large cohort of individuals, previously with little realistic hope of any meaningful recovery from spinal cord injury, may benefit from this intervention."

Epidural stimulation, in the context of paralysis of the lower extremities, is the application of continuous electrical current, at varying frequencies and intensities to specific locations on the lumbosacral spinal cord, corresponding to the dense neural bundles that largely control movement of the hips, knees, ankles and toes.

"This is a wake-up call for how we see motor complete spinal cord injury," said Edgerton, who has been conducting fundamental research in this area for 38 years and is a member of the Reeve Foundation's International Research Consortium on Spinal Cord Injury. "We don't have to necessarily rely on regrowth of nerves in order to regain function. The fact that we've observed this in four out of four people suggests that this is actually a common phenomenon in those diagnosed with complete paralysis."

Dr. Angeli and her colleagues are optimistic that the therapy intervention will continue to result in improved motor functions. In fact, based on observations from the research, there is strong evidence that with continued advancements of the epidural stimulator, individuals with a complete spinal cord injury will be able to bear weight independently, maintain balance and work towards stepping.

For more information about epidural stimulation and other spinal cord injury research, please visit chartingourcourse.org/research/victory.html and christopherreeve.org/epi

For research information, patient bios and multimedia, please visit app.box.com/s/22vptu3trdhddy57j69i

SOURCE Christopher & Dana Reeve Foundation

Released: 04/08/14

Southwest Symposium 2014

This year’s Southwest Symposium in Austin, Texas brought together leading practitioners and educators with students and healthcare professionals to share knowledge and experience. Billed as an integrative medicine conference that would get to “The Heart of the Medicine,” it lived up to expectations. Not only were many of the presenters among the leading acupuncturists in the field, but there were also several outstanding presentations made by individuals from other fields, from naturopathy to addiction recovery and one of the nation’s preeminent psychologists. Southwest Symposium 2014 was in every way an engaging learning opportunity.

The opening night’s plenary was presented by Dr. James Prochaska, the Director of the Cancer Prevention Research Center at The University of Rhode Island and developer of the Transtheoretical Model of Behavior Change. In his rousing presentation, he talked about change, particularly how we can help individuals through the process of creating successful life change. His groundbreaking book, Changing for Good, which he coauthored with Drs. John Norcross and Carlo DiClemente, provides detail on his change model.

Lonny Jarrett’s seminar focused on the heart/kidney axis as the physiological foundation of stability and restoring integrity to this most important relationship. He emphasized the importance of the practitioner's awareness of the dimension of self that is never wounded or traumatized as a gold standard in diagnosis and treatment. Clinical strategies for treating heart shock and stagnation in the diaphragm were also covered in detail.

While many practitioners attend continuing education events to collect clinical pearls and protocols to apply to their practice, it was exceptional to gain clinical insights while also experiencing presentations that illuminated my role as a practitioner within the context of my own spiritual practice. By reminding me of the direct connection between the willingness and depth of the practitioner’s journey into self and the relationship forged with the client from that depth, another dimension to true healing was revealed. I became an acupuncturist to help individuals become healthier in mind, body, and spirit. These presentations brought into sharp focus the healing presence of the practitioner, and inspired a deepening of my personal practices and awareness to enhance my clinical practice.

I brought this enthusiasm to a second keynote address given by Dr. Constance Scharff. Dr. Scharff specializes in addiction research and serves as the Senior Addiction Research Fellow and Director of Addiction Research for Cliffside Malibu. In Dr. Scharff’s passionate address, she discussed changing understandings of the nature of addiction, arguing that addiction is not the genetic disease that Western medical science suggests, but rather a neuropsychological disorder in which brain function is co-opted to the point that healthy decisions can no longer be made. She cited new research in neuroscience and the ways in which that research is being applied to improve addiction treatment outcomes. The treatment protocol used at Cliffside Malibu is also based on the work of Dr. Prochaska, and Dr. Scharff’s presentation gave useful applications for Prochaska’s theories. Dr. Scharff also generously provided every conference participant with a copy of her Amazon.com bestselling book, Ending Addiction for Good.

In a joint session titled “Hormone Dysregulation and Environmental Toxins,” Drs. Becky Andrews and Amy Neuzil discussed where the pattern language of permaculture and systems thinking meets patterns in health, demonstrating that complete healing of the individual requires change on the individual, community, and global scales. Drs. Andrews and Neuzil used principles of permaculture and insights from functional medicine to illustrate how hormones work within the body, environmental toxins are accumulated, and the system is detoxed. Major pathological processes were discussed in this framework, from global concepts to the problem of hormone dysregulation across a variety of clinical presentations. Drs. Andrews and Neuzil also provided a review of specific therapies to restore hormone balance.

These four programs were only a taste of the presentations available at the Southwest Symposium 2014. I am grateful to AOMA and the Southwest Symposium committee for their continued dedication to bring together stimulating and inspiring presenters for their integrative medicine conference. I look forward to applying clinical strategies as well as developing the ideas presented to inspire and empower my patients.

Released: 04/04/14

Reproductive or Thyroid Hormones and Menstrual Cycle Not Influenced by S-equol Supplement Designed to Manage Menopause Symptoms

A daily dose of S-equol (13.1 mg), delivered via a fermented soy germ-based nutritional supplement to manage menopause symptoms, showed no impact on reproductive or thyroid hormones or the menstrual cycles of premenopausal women, according to a peer-reviewed study reported in a poster at the Academy of Women's Health 2014 annual meeting in Washington, DC.

Previous controlled clinical trials documented that daily doses of the supplement containing S-equol, a metabolite of the soy isoflavone daidzein, relieved menopausal symptoms, specifically hot flash frequency and muscle discomfort, in both US and Japanese postmenopausal women.

"These data demonstrate that in premenopausal women, use of this supplement does not impact levels of specific endocrine hormones. Furthermore, the S-equol supplement does not impact menstrual cycles of premenopausal women which helps to confirm and expand what we know about safety of the S-equol supplement from previous studies," said coauthor Belinda H. Jenks, PhD, Director of Scientific Affairs & Nutrition Education at Pharmavite LLC, the makers of Nature Made vitamins and minerals and a subsidiary of Otsuka Pharmaceutical Co., Ltd., which supported the study.

S-equol has the ability to bind to the same estrogen receptors as naturally occurring estrogen, with a strong affinity to the estrogen receptor beta. On binding to the receptor, S-equol mimics some, but not all, activities of estrogen. Because of these actions at the receptor, it has been proposed that S-equol may alleviate some menopause symptoms caused by diminished estrogen production.

No Impact from S-equol Supplements on Reproductive or Thyroid Hormone Levels and Menstrual Cycle in Premenopausal Women

During the treatment period and post-treatment period, each of which was lasted for one menstrual cycle in each subject, a dose of a supplement containing 13.1 milligrams (mg) S-equol daily did not significantly alter the levels of five reproductive and three thyroid hormones from pre-treatment values, which remained within the normal range and did not differ from levels in women receiving a placebo in a study of 35 Japanese women aged 20 to 38 years. Moreover, neither the supplement nor the placebo affected the length of the women's menstrual cycles, which averaged 28.4 to 30.0 days, p=0.430 for the difference between groups and p=0.921 for the differences in the three cycle phase measures.

Specifically, the women receiving the supplement did not differ from the 18 women receiving the placebo in delta changes of the levels of luteinizing hormone (treatment minus pre-treatment: p=0.260 and post-treatment minus pre-treatment: p=0.486), follicle stimulating hormone (p=0.322 and p=0.456), estradiol (p=0.712 and p=0.703), progesterone (p=0.085 and p=0.462) and testosterone (p=0.720 and p=0.764). Additionally, the two groups did not differ in measures for levels of thyroid stimulating hormone (p=0.082 and p=0.111), free T3 (a form of triiodothyronine) (p=0.197 and p=0.416) and free T4 (a form of thyroxine), (p=0.223 and p=0.724).

Investigators took blood samples from each woman during the early follicular phase, about three to five days after onset of the period, the late follicular phase, about 10 to 13 days after onset of the period, and the luteal phase, about seven to 10 days after ovulation. The investigators repeated these blood samples during the course of three sequential cycles. During the first and last cycles, the women did not take any treatment, while during the middle cycle; the women received either the supplement or a placebo based on random assignment to a treatment group. This treatment lasted approximately four weeks, depending on the duration of the women's individual cycles.

Only women who had regular menstrual cycles, 28 to 35 days, were accepted and enrolled and of these, 12 were natural equol producers after soy consumption. All of the women self-checked their ovulation cycles using commercial urine tests.

SOURCE Pharmavite LLC

Released: 04/03/14

Thorne Research Introduces a New Product, NiaCel, Featuring NIAGEN, To Support Healthy Aging

Thorne Research today announced the launch of NiaCel, an innovative nutritional supplement that supports endurance, energy, and healthy aging. NiaCel is one of the first commercially available products to feature the ingredient NIAGEN from ChromaDex Corp. (OTCQB: CDXC), an innovative natural products company that provides proprietary ingredients and science-based solutions to the dietary supplement, food and beverage, animal health, cosmetic, and pharmaceutical industries.

ChromaDex developed its breakthrough patent-protected ingredient NIAGEN as the first and only commercially available brand of nicotinamide riboside (NR). NR, the active ingredient in NiaCel, boosts levels of NAD+ in cells and tissue. Studies have demonstrated that increasing the levels of NAD+ can support healthy aging by stimulating mitochondrial energy production, as well as by activating sirtuin function.

Paul Jacobson, the CEO of Thorne Research, stated, "We are very excited to offer NIAGEN nicotinamide riboside to our practitioner network through this new, exclusive product launch. NiaCel provides practitioners with a powerful new solution to promote healthy aging in patients. NIAGEN is one of the most innovative new ingredients developed in the past decade. We are thrilled to partner together with ChromaDex and our practitioner-customer base to enhance patient health with the introduction of NiaCel."

Frank Jaksch, ChromaDex founder and CEO, stated, "NiaCel is truly a groundbreaking product. We are pleased to have Thorne Research feature NIAGEN, our branded nicotinamide riboside, in such a prominent product launch."

SOURCE ChromaDex Corp

Released: 04/02/14

Hevert Partners with NCNM, Grants $495,000 Award

Five-Year Pledge to Support Residencies, Homeopathic Curriculum and Clinics

PORTLAND, Ore. (Mar. 27, 2014):

In a major show of support for the advancement of homeopathic medicine in the United States, Hevert Pharmaceuticals announced today that it has partnered with the National College of Natural Medicine, pledging its support with a gift of $495,000 that will help provide funding for groundbreaking new college programs through August 2018. The donation will underwrite several key initiatives developed jointly by Hevert and NCNM, including The Hevert Naturopathic Residency Program, The Hevert Homeopathic Symposium, the development of an accredited Master of Science in Homeopathy Degree, The Hevert Starter Medicinary Program, and The Hevert Collection. The grant also includes an in-kind gift of Hevert products to NCNM's community clinics.

Hevert Pharmaceuticals, one of the world's leading manufacturers of homeopathic medicines, is dedicated to naturopathy and the development of high-quality natural medicine. Founded in Germany in 1956 by pharmacist Emil Hevert, Hevert Pharmaceuticals is an independent, family-owned company run today by Mathias Hevert, its third-generation president. In addition to its manufacturing excellence, the company is strongly committed to environmental protection, sustainable business practices and responsibility for its employees and community.

HevertUSA President and CEO Wolf Aulenbacher introduced the new partnership by saying:

“It is especially gratifying to me to be able to bring Hevert and NCNM together, not only professionally as HevertUSA CEO, but personally, as someone who has spent his lifetime working with naturopathy and homeopathy. Hevert’s goal is to preserve the rich legacy of naturopathic pioneer Pastor Emanuel Felke and bring our safe, naturally effective homeopathic medicines to the U.S. We are honored to be in the position to support the many uniquely deserving programs that NCNM brings to the natural health care community and public, and welcome the opportunity to contribute toward the ongoing education, continued advancement and, ultimately, increased adoption of homeopathy in the United States.”

Although naturopathic medicine is now licensed in 17 states, the District of Columbia, two U.S. territories, and recognized by the Affordable Care Act, Hevert and NCNM share in the belief that there is still much work to be done to broaden the reach and influence of naturopathy and homeopathy in the U.S. and bring them the recognition they deserve. To this end, Hevert is extremely honored to be joining NCNM in bringing these landscape-altering initiatives to the medical community and public, and looks forward to a long and productive association with its new partner.

For additional program details and information on Hevert Pharmaceuticals, please visit www.hevertusa.com.

For more on NCNM, please go to www.ncnm.edu.

ABOUT HEVERT

Hevert Pharmaceuticals is dedicated to naturopathy and the development of natural medicines. An independent, family-owned company founded in Germany in 1956 and run by Mathias Hevert, its third-generation president, Hevert is one of the world’s leading manufacturers of homeopathic and herbal medicines, as well as high-dose vitamin preparations. The company's extensive product portfolio includes medicines for virtually every treatment area relevant to natural medicine.

ABOUT NCNM

Founded in Portland in 1956, NCNM is the oldest naturopathic medical school in North America and an educational leader in classical Chinese medicine and CAM research. NCNM offers three accredited four-year graduate medical degree programs in naturopathic and classical Chinese medicine, as well as Master of Science degrees in Integrative Medicine Research and Nutrition. Its community clinics provide low-cost medical care throughout the Portland metropolitan area. In addition to the campus-based NCNM Clinic, NCNM practitioners attend to approximately 40,000 patient visits per year.

Released: 04/02/14

High-risk opioid users have medical costs three times higher than other opioid users

People who are at high risk for opioid abuse use had significantly higher total medical costs ($19,513 vs. $5,493) than those who were not at high risk, according to a new study by Prime Therapeutics (Prime). The Centers for Medicare & Medicare Services (CMS) defines high risk as "using a daily morphine equivalent dose (MED) of greater than 120 mg for at least 90 consecutive days, plus using more than three pharmacies and more than three unique prescribers." Prime, a leading pharmacy benefit manager, will be presenting these findings at the Academy of Managed Care Pharmacy's 26th Annual Meeting & Expo in Tampa, Florida.

During the first half of 2013, Prime reviewed opioid claims from more than 9 million commercially insured members. The research found nearly 1.2 million (13.1 percent) had at least one opioid claim. While 11,518 (0.13 percent) met the MED threshold, just 225 (0.0025 percent) met all three CMS high risk criteria. The number of commercially insured members considered high risk for prescription opioid abuse was five times lower than the rate among Medicare Part D members.

Those meeting all three criteria did not have significantly different pharmacy costs. Prime's study excluded members being treated for cancer as CMS does in its analysis.

The average age for members meeting all criteria was 43. Arthritis and back, neck, and abdominal pain were among the most common pain diagnoses in this group. Anxiety, bipolar disorder, and depression were more common than in the group that just met the MED criteria.

"Nationally, as many as 2 million people a year use opioids for non-medical purposes, and identifying high-risk indicators can help prevent abuse and misuse of these medications," said Pat Gleason, PharmD, BCPS, FCCP, director of health outcomes for Prime.

Source: Prime Therapeutics LLC, primetherapeutics.com

Released: 04/01/14

New Textbook on the Consumption of Sugar/Fructose Offers a Unique Nutrition

A new textbook, Fructose, High Fructose Corn Syrup, Sucrose and Health, published this month by Springer Press, under their Humana Press imprint, provides one of the most comprehensive scientific analyses on the closely-watched issue of caloric sweetener consumption. It represents the most up-to-date review of relevant scientific data that seeks to provide facts and dispel myths for audiences that often receive conflicting information about sugar/fructose consumption.

Chapters in the book discuss the effects of both nutritive and non-nutritive sweeteners on appetite and food consumption, as well as the physiologic and neurologic responses to sweetness. Chapter authors are world class, practice and research oriented nutrition authorities. They provide practical, data-driven resources based upon the totality of the evidence to help the reader understand the basics of fructose, high fructose corn syrup and sucrose biochemistry. The textbook also examines the short-term and long-term consequences of consuming these sweeteners in the diets of young children through to adolescence and adulthood.

"The issue of sugar and fructose consumption is one of the more prominent health issues currently being debated and there is quite a bit of misinformation and hyperbole in this issue," said the textbook's editor, James M. Rippe, MD, Founder and Director of the Rippe Lifestyle Institute and Professor of Biomedical Sciences at the University of Central Florida. "We were fortunate to get some of the best minds in the field of nutritional science to provide unvarnished, scientific facts about this issue in hopes of providing greater public understanding and a strong foundation for future scientific research in this field."

Some chapter highlights include:

"Added Sugars and Health" by John L. Sievenpiper, MD, PhD, McMaster University : "Concerns raised by fructose's unique biochemistry and the ecological and animal studies linking