In the News

New Research Holds Promise for Cancer Immunotherapy Treatments

Strong Correlation Between Cerebral Aneurysms And Early Onset Menopause

FDA clears Roche's vitamin D laboratory test

Children's Hospitals and Clinics of Minnesota wins international award

Thorne Research, Integrative Health Resources and Dr. Daniel G. Amen Launch New Venture Targeting Cognitive Health

New Research Advances Validation Of New Diagnostic Guidelines

Modified Citrus Pectin Boosts Effectiveness of Doxorubicin Against Prostate Cancer

Vitamin D Supplementation May Not Reduce Cholesterol-Related Heart Disease Risk

China Health Resource Develops Revolutionary Migraine Medication

New Multicenter Study Shows D-Ribose Increases Energy 61 percent in CFS and Fibromyalgia Patients

Sleep Duration, Sleep Disorders, and Circadian Patterns are Risk Factors and Indicators of Cognitive Decline

Life Extension Foundation Sponsors Magnesium Sulfate Study at University of Miami

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New Research Holds Promise for Cancer Immunotherapy Treatments

Treatment Fights Cancer’s Ability to Suppress Our Immune System

New research from the Trudeau Institute laboratory of Dr. Edward L. Pearce (Washington University) has promising implications for improving a treatment for cancer known as cellular immunotherapy. The findings were just published in The Journal of Immunology.

One of the major hurdles in treating cancer patients is the fact that most cancers actively suppress our immune system, thereby stifling the patient’s ability to fight the disease. To overcome this obstacle, treatments have been designed to harvest immune cells from the cancer patient’s blood, activate these cells outside the patient, and then inject the activated cells back into the patient to jumpstart their immune response against the cancer.

Studying melanoma cancer in mice, Trudeau researchers found that activating immune cells in the presence of a class of drugs that affects cell metabolism can further boost the ability of cellular immunotherapy treatments that combat melanoma tumors.

“We found that this cellular drug treatment increases the activation period of the immune cells, so that when we inject them back into mice bearing melanoma tumors, we get larger immune responses against the tumors and better control of tumor growth,” said Eyal Amiel, PhD, a postdoctoral fellow at Trudeau and lead author of The Journal of Immunology study.

Ongoing investigations from the study’s authors will lead to human trials, improving immunotherapy treatments for those effected by many types of cancer.

 

Strong Correlation Between Cerebral Aneurysms And Early Onset Menopause

A correlation between brain aneurysms, bulges or balloons in vessel walls, and early onset menopause has been identified, according to recent study results presented at the SNIS 9th Annual Meeting in San Diego, CA, thereby suggesting that the premature loss of estrogen could be a risk factor for aneurysm formation and development. As it is known that the incidence of aneurysm rupture or subarachnoid hemorrhage (SAH) surges following menopause, a time when estrogen fluctuations are prevalent, these findings may also help define a target population of women for future treatment.

Although the last few decades have introduced better and faster methods of detecting and treating unruptured aneurysms, the incidence of SAH, approximately 30,000 Americans each year, has remained largely unchanged. Furthermore, mortality rates for ruptured aneurysms continue to average around 50%. "In order to meaningfully reduce the occurrence of eventual aneurysm rupture and bleeding in the brain, it is imperative that the medical community better understand cerebral aneurysms and their disease development and progression," said Michael Chen, Assistant Professor of Neurology, Neurosurgery and Radiology at Rush University Medical Center in Chicago, Illinois and the study author. "Understanding all of the contributing factors to aneurysm development is fundamental to then considering how we approach this disease process. Similar to a puzzle, each individual piece is important to the overall picture."

Findings resulted from a retrospective, case-control study that compared the gynecologic and medical histories of 76 cases of consecutive postmenopausal women who were diagnosed with brain aneurysms and treated by a single physician from 2009 to 2011 to 532 controls, seven controls for each case, identified in the general population from 1994 to 1998. The only criteria utilized in the control group selection were age and educational level comparable to case subjects. Approximately ten variables were compared between the two groups, including age of menopause onset.

Results showed that 20 of the total cases with brain aneurysms (26.3 percent) had undergone pre-mature menopause, defined as under age 40, as compared with 102 of the control group (19.2 percent). When comparing across all variables, later menopause age (OR 0.79, CI 0.63 to 0.996, p1/40.046) was significantly associated with a lower aneurysm incidence. Additionally, for each categorical increase in menopause age (40-44, 45-49, 50-54, and greater to or equal to 55), the likelihood of developing a brain aneurysm decreased by 21 percent. The mean menopause age in both case and control groups showed no significant difference (44.3 and 44.7 respectively).

Beyond findings associating aneurysm incidence and the age of menopause onset, the study also found that the use of HRT, in 27.6 percent of the case group as compared with 58.8% of the control group, was significantly associated with lower aneurysm incidence. Together with the correlation between early menopause and the development of brain aneurysms, and existing data that HRT seems to reduce the risk of SAH in post-menopausal women, says Chen, "this finding compels us to consider how to design treatment options, such as HRT, for a specific age spectrum of women with cerebral aneurysms."

The study was conducted using a custom-designed questionnaire that was provided to all case and control group members. The latter group was selected from profiles of 4,682 women who provided their medical and gynecological histories as part of a federally-funded initiative called the National Institute of Child Health and Human Development-sponsored Contraceptive and Reproductive Experiences Study (CARES), which sought to examine whether any link existed between oral contraceptive pill (OCP) and HRT usage and the risk of developing breast cancer. Variables compared across the two groups included body mass index, smoking and drinking prevalence, age of menarche onset, number of pregnancies and non-pregnancies, cases of hysterectomy and age of first live birth.

Compared with the control group, the case group showed no statistically significant difference in age, BMI, menarche age, mean age at menopause and percentage of women who had undergone a hysterectomy. In contrast, factors that did demonstrate a statistically significant difference between the two study groups included younger mean age at first live birth (p1/40.03), lower percentage of current drinkers (p1/40.04) and greater mean number of pack years (p1/40.04) in the case group.

According to recent statistics, approximately six million people in the US have an unruptured brain aneurysm, or about one in 50 people.

 

FDA clears Roche's vitamin D laboratory test

Fully automated assay for widely available platforms offers labs efficient solution to help assess patient vitamin D levels

Roche announced today that it has received clearance from the US Food and Drug Administration (FDA) for a fully automated vitamin D test for use on cobas modular platforms, further expanding the company's bone metabolism test menu.

Vitamin D is an important building block for human health and is mainly produced in the skin by exposure to sunlight. Vitamin D deficiency plays a major role in bone metabolism disorders, and in recent years studies have linked vitamin D deficiency with many other disease states, including cancer, cardiovascular disease and diabetes.

"The demand for vitamin D testing in the US is increasing rapidly, and having a large installed base of cobas analyzers will allow labs to easily respond to that demand and integrate the Roche test into their existing workflow," said Daniel O' Day, chief operating officer of Roche Diagnostics. "Adding this test enables them to offer precise and accurate results to help clinicians assess vitamin D sufficiency in adult patients so they can provide optimal care."

An estimated one billion people suffer from vitamin D deficiency worldwide.

For more information: roche.com or roche-diagnostics.us.

 

Children's Hospitals and Clinics of Minnesota wins international award

Evidence-based program cited as a model for other children's hospitals

Children's Hospitals and Clinics of Minnesota received the top international award for "Use of Art in the Patient Environment" from the International Academy of Design and Health for its program "Arts & Healing and Urban Renewal."

Partnering with Aesthetics Inc., the program was selected out of almost 100 submissions from organizations representing more than 30 countries around the world. The award honors organizations specifically for professional excellence and ability to bring research and design into creating a health-promoting environment.

Children's multi-pronged "Arts & Healing and Urban Renewal" program creates a warm, creative atmosphere to promote healing and enhance the child and family experience, engages patients in hands-on art projects, and forges partnerships with community organizations.

"Children's Hospitals and Clinics of Minnesota implemented a research-based healing arts program that is both broad and innovative and possesses salutgenic qualities," said Prof Alan Dilani, director-general at International Academy of Design and Health. "This program has made a positive difference for children dealing with medical issues and is an international model for other children's hospitals."

From the first moment of entering Children's Hospital in Minneapolis or St. Paul through diagnosis, treatment and discharge, patients and families are immersed in an environment designed to support healing and promote inner resilience.

Children's Arts & Healing and Urban Renewal project, which was launched in January 2010, has been entirely supported through the generosity of the community, through individual, corporate and government grants. The program has been well received by patients and families with 80 percent indicating in a survey that they stop and personally interact with the art. In addition, for children participating in the hands-on art projects, 41 percent said they felt better after the project.

"A growing body of evidence suggests the integration of arts positively contributes to health outcomes and the health care experience for patients, families and staff," said Theresa Pesch, RN, executive director, Children's Foundation, and VP, Development, Children's Hospitals and Clinics of Minnesota. "We believe that the experience of art is healing and designed an integrated program where our patients and families can view and interact with art, make art and watch live performances."

To bring the arts program to life, Children's partnered with leading community organizations: COMPASS, MacPhail Center for Music, the Children's Theatre Company, Minneapolis Institute of the Arts and the Minneapolis Children's Museum. Children's recently added partnerships with the Guthrie Theater and the Science Museum of Minnesota.

 

Thorne Research, Integrative Health Resources and Dr. Daniel G. Amen Launch New Venture Targeting Cognitive Health

Venture to develop portfolio of supplements, nutritional tools and exercises to support healthy brain function.

Thorne Research, Inc, a leader in developing and manufacturing pure, high quality nutritional supplements marketed through licensed healthcare practitioners, today announced that the company has partnered with Integrative Health Resources, LLC (IHR) and Daniel G. Amen, MD, to co-develop novel nutritional formulations and a portfolio of resources to assist patients and medical providers with managing cognitive health and neurological supportive care.

The partnership will facilitate broader patient access to nutritional supplements and cognitive tools, including online assessments and nutrition tracking tools and brain enhancement exercises and games. These products and programs are designed to support patients with a wide range of mental conditions that affect cognitive function, including depression, anxiety, attention disorders, chronic stress and memory challenges.

"Thorne Research is proud to expand our nutritional supplement portfolio in the area of cognitive health, which represents a major area of unmet need in patients in the US. Working closely with Dr. Amen and the team at IHR, we plan to develop an unmatched range of outstanding products and support resources designed to improve brain performance," said Paul Jacobson, chief executive officer of Thorne Research.

Through this joint venture, Dr. Amen, a specialist in psychiatric medicine and founder of the Amen Clinics, will lead efforts to develop a range of dietary supplements, cognitive tools and patient support resources. In his practice, Dr. Amen has pioneered the use of advanced diagnostic tools, such as SPECT imaging, to more accurately characterize neurological disorders and identify new types of mental conditions. He has also led research efforts that demonstrate the effectiveness of nutritional supplements and diet in treating mental conditions.

IHR, a provider of medical information, consulting services and products focused on natural therapeutics, wellness and integrative care, will provide support for the development of new nutritional supplement products and cognitive health resources for patients and healthcare providers. IHR is a leader in preventative health and wellness and developer of a variety of innovative health tracking tools that help individuals who suffer from neurological or behavioral disorders to accurately monitor their health.

"Better integrative health tools to monitor and treat mental health and brain performance are a key strategic need for healthcare professionals and their patients," said James B. LaValle, RPh, chief executive officer of IHR. "Brain performance can best be improved by taking daily steps to exercise cognitive function. Our joint venture will offer many new tools to help patients exercise their brain and monitor their cognitive health at home, while also providing healthcare professionals with the resources they need to advise patients on alternative treatments for cognitive impairments."

 

New Research Advances Validation Of New Diagnostic Guidelines

In April 2011, the US National Institute on Aging (NIA) and the Alzheimer's Association published new criteria and guidelines for the diagnosis of Alzheimer's disease. These guidelines separate the progression of Alzheimer's into three phases: (1) pre-clinical (or pre-symptomatic) Alzheimer's disease, (2) mild cognitive impairment (MCI) due to Alzheimer's disease, and (3) Alzheimer's disease dementia. Phases (1) and (2) were clearly described as research criteria in need of validation, especially for their first-time incorporation of biomarkers into the diagnostic process.

Two scientific abstracts reported at the Alzheimer's Association International Conference 2012 (AAIC 2012) in Vancouver by scientists with the Mayo Clinic Study of Aging (MCSA) provide encouraging data on their attempts to validate phases (1) and (2) of the new diagnostic criteria and guidelines. MCSA is a population-based study of more than 3,000 people age 70 to 89 at the time of enrollment living in Olmsted County, MN, created to investigate the prevalence, incidence and risk factors for MCI and dementia.

"The NIA-Alzheimer's Association guidelines proposed diagnostic criteria for what has become known as the 'Alzheimer's disease spectrum.' The most advanced phase – dementia due to Alzheimer's – is characteristic of what had been called Alzheimer's in previous years," said Ronald Petersen, PhD, MD, MCSA principal investigator and Director of the Mayo Clinic Alzheimer's Disease Research Center in Rochester, MN. Petersen is a member of the Alzheimer's Association Board of Directors.

"The spectrum now has expanded to include milder cases, such as those people found to have MCI due to Alzheimer's, and to the preclinical phase of Alzheimer's, when people do not have any outwardly measurable cognitive impairment but may have biological changes related to Alzheimer's," Petersen said.

"It is now generally accepted that Alzheimer's begins years, perhaps even decades, before symptoms are noticeable. Before the proposal of these new diagnostic guidelines, there was is no single, generally accepted way to identify the disease in its earliest phases – before symptoms are evident. As these two new reports show, we are making good progress in that direction," said William Thies, PhD, Alzheimer's Association chief medical and scientific officer.

"Earlier detection of people at highest risk for Alzheimer's and those who have the earliest forms of the disease will help us identify the right people for risk reduction and prevention trials, and will move the field further in the direction of early detection and treatment," Thies said.

NIA-AA MCI Alzheimer's Diagnostic Guidelines Applied to the Mayo Clinic Study of Aging?

The proposed NIA-Alzheimer's Association diagnostic criteria for MCI due to Alzheimer's are based on the clinical presentation of people with MCI and are augmented by various biomarkers, the goal of which is to enhance the likelihood that the observed symptoms are due to underlying physical and biological changes caused by Alzheimer's disease. Three levels of certainty have been introduced in the new criteria – uninformative, intermediate and highest – which are ordered according to the availability of biomarkers. The applicability of these proposed new criteria in the general population has not been widely evaluated.

Petersen and colleagues assessed the MCI criteria by applying them to 156 participants with MCI in the MCSA. For the purpose of this study, the participants were evaluated with various imaging technologies such as quantitative MRI scans, FDG PET scans, and amyloid imaging using C11 Pittsburgh Compound B (PiB) PET scans.

The researchers found that:

• Approximately 16 percent of subjects with a clinical diagnosis of MCI did not have any evidence for positive imaging biomarkers.
• Another 12 percent had evidence for the presence of amyloid on PiB scanning but no other signs of neurodegeneration.
• An additional 55 percent of the subjects had evidence for both amyloid deposition on PiB scanning and either atrophy on MRI or an FDG PET scan indicative of hypometabolism, or both.
• Finally, 17 percent of the subjects had evidence of neurodegeneration, atrophy on MRI, hypometabolism on FDG PET or both, without having evidence for amyloid deposition.
• The frequency of Apolipoprotein E4 carrier status was highly correlated with the presence of amyloid.

 

In sum, the researchers found that the majority of study subjects with MCI had evidence for amyloid deposition, neurodegeneration or both. However, some subjects classified as having MCI had no evidence of the presence of Alzheimer's biomarkers.

"These results indicate that the new diagnostic criteria for MCI due to Alzheimer's work quite well," Petersen said. "Sixty-seven percent of the participants had evidence for either amyloid deposition or amyloid plus a marker for neurodegeneration. As such, about two-thirds of the participants were thought to be highly likely to develop the dementia due to Alzheimer's. Ultimately, the validity of these new criteria will be determined by the long-term outcome of these subjects."

"Interestingly, a significant number of participants had no evidence of any biomarker positivity, and another group had evidence of brain cell loss but no amyloid. The latter group likely represents non-Alzheimer's causes of MCI, such as vascular disease," Petersen said.

Examination of the NIA-AA Proposed Diagnostic Guidelines for Preclinical Alzheimer's Disease?

The proposed NIA-Alzheimer's Association diagnostic guidelines for preclinical Alzheimer's disease are based on the presence of abnormal levels of beta-amyloid biomarkers. Beta-amyloid is the main component of amyloid plaques, which are sticky deposits found in the brains of people with Alzheimer's; plaques are one of the two hallmark brain lesions of Alzheimer's (the other are known as tau tangles).

Three stages are proposed within the preclinical Alzheimer's disease pathway:
Stage 1 – detection of abnormal levels of beta-amyloid.
Stage 2 – stage 1 plus evidence of brain neurodegeneration.
Stage 3 – stage 2 plus subtle cognitive changes.

David Knopman, MD, and colleagues examined 443 cognitively normal subjects from the MCSA who underwent brain magnetic resonance (MR) scans, 18Fluorodeoxyglucose (FDG) and Pittsburgh compound B (PiB) positron emission tomography (PET) scans, and full clinical and diagnostic assessments. Features evaluated by structural MR included hippocampal volume, white matter hyperintensity (WMH) volume and number of infarcts.

The researchers identified a group of study participants didn't fit any of the three proposed stages – they had normal beta-amyloid biomarkers and abnormal levels of neurodegeneration. They were assigned to a group labeled "suspected non-Alzheimer pathophysiology" (sNAP).

They found that:
189 (43 percent) had no abnormal imaging biomarkers.
137 (31 percent) fell into stages one to three of the preclinical Alzheimer's pathway.
102 (23 percent) were in the sNAP group.
15 (3 percent) were unclassified.

According to the researchers, people in the preclinical Alzheimer's pathway (stages one through three) were more likely to progress to cognitive impairment than the biomarker negative group (p<0.001). Those in Alzheimer's preclinical stages two and three were more likely to progress than the sNAP group (p=0.04). There was no difference in outcome between the sNAP group and the biomarker negative group.

"The NIA-AA preclinical Alzheimer's guidelines identify a group of cognitively normal persons who are at risk for cognitive decline. Those who had abnormal beta-amyloid imaging results with neurodegeneration carried a higher risk than neurodegeneration alone," Knopman said. "The use of these advanced imaging tools to explore the earliest brain changes in cognitively normal persons offers us an exciting new window to identify the markers that may eventually lead to dementia."

"We were surprised by the number of people that fell into the sNAP group and wished to learn more about them," Knopman added.

According to Knopman, they found that the sNAP group and those with Alzheimer's preclinical stages two and three were similar with one exception: the sNAP group had a lower proportion (14 percent) of people who carried the Alzheimer's risk gene, APOE-e4, than the preclinical Alzheimer's phases two & three. Otherwise, the sNAP group and those people in preclinical Alzheimer's stages two and three had similar patterns of structure, function and association with clinical features.

"In this group of cognitively normal people, it was not necessary to have abnormal levels of beta-amyloid in the brain to produce slowdowns in energy processing and physical atrophy comparable to what we usually see in the presence of high levels of brain beta amyloid," Knopman said.

 

Modified Citrus Pectin Boosts Effectiveness of Doxorubicin Against Prostate Cancer

Natural agent makes safer, lower chemotherapy doses possible

Doxorubicin (Dox) is an effective anti-cancer drug, but it's also a very toxic one, causing severe heart and immune damage. The doses needed to impact tumors are not well tolerated by patients; however, researchers may have found an answer through combination therapy. A study published in the journal Cell Biology International has shown that combining Dox with the natural supplement Modified Citrus Pectin (MCP) increases the anti-cancer activity of Dox. This finding bodes well for prostate cancer patients, especially those too weak for normal chemotherapy regimens. Combination therapy may allow for lower doses of Dox with enhanced clinical impact and reduced toxicity.

The study, conducted by researchers at Tehran University, tested whether combining Dox with MCP would increase their effectiveness against prostate cancer cells in vitro. The team used two forms of prostate cancer: androgen-dependent (LNCaP) and androgen-independent (DU-145). The results were impressive, as the combination treatment reduced cancer cell viability by more than 67 percent in both types. Specifically, the researchers were looking at the cell cycle, the cell division process, and apoptosis—the programmed cell death mechanisms that destroy aberrant cells and are often impaired in cancers.

"This study demonstrates that modified citrus pectin enhances the cytotoxic effect of Doxorubicin in both androgen-dependent but more importantly in androgen-independent prostate cancer," said integrative medicine pioneer Isaac Eliaz, MD, who developed the MCP used in the study. "This is especially important because prostate cancer patients who do not respond to hormone therapy and require chemotherapy are often the most in need of advanced treatments."

Androgen-dependent prostate cancer is often treated by depriving it of hormones. Androgen-independent prostate cancers no longer respond to hormone therapy, having developed new mechanisms to grow and thrive. The combination treatment worked against the androgen-dependent form by shutting down the cell cycle. The treatment killed the androgen-independent cells by boosting apoptosis.

This is the latest in a series of studies that have supported MCP's ability to fight prostate cancer. As early as 1995, a study by researchers at Wayne State University found that MCP inhibited metastasis to the lungs in animals with prostate cancer. A phase I clinical trial in 1997 and a phase II clinical trial published in 2003, showed MCP slowed cancer growth in human subjects. A study in 2007 at Albert Ludwigs University in Germany found clinical benefit for advanced cancer patients receiving MCP treatment. And a study in 2010, conducted at Columbia University, showed MCP induces apoptosis and reduces proliferation.

"The ability of such a safe supplement to decrease the needed dosage of Doxorubicin is very significant," said Dr. Eliaz. "Combination therapy using MCP allows lower levels of Doxorubicin to be used with greater effect on inducing rapid cell death in the hard-to-treat androgen-independent prostate cancer cells, and halting the viability of the androgen-dependent prostate cancer cells. The lower doses and increased effectiveness are a win-win."

For more information on Modified Citrus Pectin call 707.583.8619, email info@betterhealthpublishing.com, or visit mcprecommends.org.

 

Vitamin D Supplementation May Not Reduce Cholesterol-Related Heart Disease Risk

Raising vitamin D to optimal from deficient blood levels may not improve total cholesterol and other blood lipids, key markers of cardiovascular disease risk, according to a study published today in Circulation, a publication of the American Heart Association. The study, by researchers at Quest Diagnostics and The Rockefeller University, is the first large-scale examination of the clinical impact of correcting vitamin D deficiency on lipid levels and associated cardiovascular disease risk.

"Prior studies have associated low vitamin D level with an unhealthy lipid profile, but the effect of therapeutically correcting a vitamin D deficiency by itself on lipids is unclear," said lead investigator Manish Ponda, MD, MS, assistant professor of Clinical Investigation for The Rockefeller University's Laboratory of Biochemical Genetics and Metabolism. "This novel study on a large U.S. population suggests that correcting a vitamin D deficiency may not translate into a clinical benefit on the lipid profile. Patients should follow their physician's advice on whether vitamin D supplements are right for them."

An accompanying editorial in Circulation characterizes the study as having "great importance" for demonstrating that biomarkers, such as vitamin D, that are associated with disease risks in certain types of studies may not be found to cause those risks in other types of research.

Optimal vitamin D levels associated with favorable lipids
Heart disease is the number one killer of men and women in the United States, and individuals with high total cholesterol levels have twice the risk of heart disease as people with optimal levels. Several studies show an unfavorable association between deficient levels of vitamin D and cardiovascular disease markers such as total cholesterol and other lipids. However, randomized controlled studies are pending to assess if vitamin D deficiency is a cause or merely a marker of poor heart health and the effect of therapy to correct a deficiency.

The researchers conducted two studies on patients tested for vitamin D and lipids by Quest Diagnostics in the United States. The first study involved a cross-sectional analysis of 107,811 patients to assess differences in lipid levels between those with optimal and deficient vitamin D levels. Cross-sectional studies evaluate a study population in one moment in time.

The analysis found that patients with optimal levels of vitamin D, defined as 30 ng/ml or higher, had a statistically significant lower lipid risk profile, including lower overall total cholesterol, LDL ("bad") cholesterol and triglycerides, and higher HDL ("good") cholesterol, compared to those with deficient levels measuring less than 20 ng/ml.

The Endocrine Society defines vitamin D levels of 30 ng/ml or higher as optimal and 20 ng/ml or lower as deficient. The Institutes of Medicine defines 20 ng/ml as sufficient for most adults for bone health, but does not correlate vitamin D with cardiovascular health.

"Increases in vitamin D levels were associated with step-wise improvements in lipids. Although these findings support prior association studies, they do not demonstrate if vitamin D is a causal factor in lipid health or a passive marker for it," said investigator Harvey W. Kaufman, MD, senior medical director, Quest Diagnostics.

Supplementation to raise vitamin D levels does not improve lipids
The investigators also performed a longitudinal analysis to assess the impact of therapy to correct vitamin D deficiency on lipid levels. Longitudinal studies evaluate changes in a study population over time. Pharmacological, oral vitamin-D therapy is typically administered to raise vitamin D levels in patients with vitamin D deficiency, although over-the-counter supplements are also widely available.

The longitudinal study examined data for 8,592 patients re-tested between four and 26 weeks. It showed that raising vitamin D levels from deficient to optimal levels had no statistically significant effect on LDL cholesterol or triglycerides, and had a small, but clinically minimal impact on total and HDL cholesterol. "The seemingly conflicting findings of the cross-sectional analysis and longitudinal analysis suggest that while vitamin D deficiency is associated with an unfavorable lipid profile, correcting a deficiency through therapeutic vitamin D supplementation may have limited value in improving lipids," said Dr. Ponda.

Data mining in lieu of large trial
Randomized clinical trials (RCT) are considered the gold standard of clinical research on therapeutic interventions, but can require years and considerable financial investment to complete. The investigators in this study employed sophisticated data mining techniques to analyze the Quest Diagnostics dataset to provide insights on the therapeutic effect of vitamin D repletion. The company maintains the largest private source of laboratory patient data and publishes Quest Diagnostics Health Trends™ reports in peer-reviewed journals as a public service.

In an editorial, Drs. Rolf Jorde and Guri Grimnes write that the study is "… of great importance as it underscores that cross-sectional results are not necessarily reproduced in prospective studies, and that cross-sectional data cannot and should never be taken as evidence for causality." They also characterize it as "another approach that with its cost-effectiveness is highly attractive" and suggest similar study methods "could be used by others with access to large databases with laboratory results."

"In the absence of RCT, observational studies based on mining large, clinical databases can provide important medical insights. Our novel, inexpensive analysis fills a major gap in current medical research on vitamin D," said Jan L. Breslow, MD, Frederick Henry Leonhardt Professor and head of The Rockefeller University's Laboratory of Biochemical Genetics and Metabolism. "An analogous prospective, randomized, controlled trial would take years to complete and possibly be prohibitively expensive. While additional research is required to confirm our findings, our study provides clinically valuable insights to help guide patient management until these other trials are performed."

The study's strengths include its national scope and size, which allowed the investigators to control for age and gender, and to identify clinically significant relationships between vitamin D levels and lipid profiles. Data was obtained from actual patients in settings reflective of true clinical practice across the United States. Limitations include lack of access to medical records to determine reasons vitamin D testing was performed or factors that influence lipids, such as body mass index and medications. The Western Institutional Review Board reviewed the process used to perform the study.

The study, titled "Vitamin D May Not Improve Lipid Levels: A Serial Clinical Laboratory Data Study," is in the July 17 issue of Circulation, which is also available online at: circ.ahajournals.org/content/early/2012/06/18/CIRCULATIONAHA.111.077875.abstract.

 

China Health Resource Develops Revolutionary Migraine Medication

CHRI's proprietary DAR is used as key ingredient

China Health Resource, Inc. announced today the successful development of a revolutionary TCM migraine medication called Toufeng Migraine tablet. The medication has demonstrated an effective rate of 96.5 percent in clinical observations. The new product was developed utilizing the company's Dahurian Angelica (DAR) as one its key ingredients.

According to the company's forecast, the world's major pharmaceutical markets (USA, France, Germany, Italy, Spain, Britain and Japan) for anti-migraine drug sales will grow from $2.86 billion in 2002 to over $5.6 billion by 2013. Unlike Toufeng Migraine tables, most available medications are painkillers and many have serious side effects or carry a risk of dependency and addiction.

"Toufeng Migraine tablets have proven effective in our tests. It is naturally derived from our trademarked Sichuan DAR. This new product has a strong export market demand with a potential for immeasurable health benefits. We expect this to provide tremendous economic growth for CHRI," says Jiayin Wang, Chairman and CEO of CHRI.

The company is now moving forward with the approval process world-wide and is working to develop and expand commercialization through strategic partnerships.

The American Headache Foundation statistics show that one in every ten people in the United States suffers from migraine headaches, but more than half the patients fail to report it. According to international epidemiological surveys, the incidence of migraines world-wide is 8.4 percent to 28 percent. Data from the US National Institute of Neurological Disorders and Obstruction shows that lost productivity by migraine patients in the United States has reached 157 million working days a year. In China, prevalence rate for migraine is 9.85 percent and the annual incidence rate is 7.97 percent. With China's population of 1.3 billion, this percentage translates to 103.6 million people. Migraine headaches have become a major international problem.

"The company is committed to the development and commercialization of effective, innovative and natural health solutions. We are very pleased with this new development of Toufeng tablets," adds Mr. Wang.

 

New Multicenter Study Shows D-Ribose Increases Energy 61 percent in CFS and Fibromyalgia Patients

A new multicenter study published in The Open Pain Journal showed that daily consumption of the pentose carbohydrate D-ribose (Corvalen: 5 grams, three times a day over three weeks) resulted in an average energy boost of 61 percent among patients diagnosed with Chronic Fatigue Syndrome (CFS) and fibromyalgia (FMS). In addition, sleep, pain, mental clarity and overall well-being improved. The study, headed by board certified internist Jacob Teitelbaum, MD, involved 257 people with (CFS) and FMS from 53 different health clinics.

The research showed that consuming D-ribose led to both statistically (p<.0001) and clinically highly significant average improvements in all categories:
61.3 percent increase in energy
37 percent increase in overall well-being
29.3 percent improvement in sleep
30 percent improvement in mental clarity
15.6 percent decrease in pain

These findings confirmed results of an earlier pilot study published in the Journal of Alternative and Complementary Medicine, involving 36 patients from a single medical center, who took D-ribose for an average of 25 days. Approximately 66 percent of patients experienced significant improvement while on D-ribose, with an average increase in energy of 45 percent and an average improvement in overall well-being of 30 percent (p<.0001).

The purpose of the new study was to reconfirm the efficacy of D-ribose for improving the quality of life in energy-depleted patients diagnosed with fibromyalgia (FMS) and/or CFS, and to see if the results could be generalized to the CFS and FMS community as a whole.

"Today we're facing a human energy crisis of major proportions. Reflecting this, the prevalence of Chronic Fatigue Syndrome and its painful cousin fibromyalgia has grown dramatically in recent years," said lead researcher Jacob Teitelbaum, MD, author of the bestselling From Fatigued to Fantastic! "FMS affects between 3-6 million and CFS affects over one million Americans, mirrored by comparable numbers in at least five European countries."

According to Dr. Teitelbaum, D-ribose provides the key building block for producing the "energy molecule" adenosine triphosphate (ATP) in every cell. ATP levels have been found to be 80 percent higher in healthy vs. CFS patients. "Our hypothesis all along has been that giving D-ribose to people with CFS/FMS will jump-start their mitochondrial energy furnaces. We're pleased that the larger multicenter trial corroborated our earlier study, showing the same benefits for fibromyalgia and CFS patients from multiple locations."

Dr. Teitelbaum is also the lead author of the landmark study on effective treatment for CFS and fibromyalgia published in the Journal of Chronic Fatigue Syndrome (8:2,2001), which found that 91 percent of patients showed an average 90 percent improvement in quality of life using the SHINE medical protocol. [3] His latest book, Real Cause, Real Cure (Rodale Press) will be published in August.

PR Newswire (http://s.tt/1i1Wr)

 

Sleep Duration, Sleep Disorders, and Circadian Patterns are Risk Factors and Indicators of Cognitive Decline

Four studies reported today at the Alzheimer's Association International Conference 2012 in Vancouver suggest a relationship between sleep quality and quantity and risk of cognitive decline, and that interventions to normalize sleep duration and correct sleep disorders may not only improve quality of life, but have potential to reduce or prevent cognitive decline.

"We know that sleep patterns change as people age and that poor sleep affects overall health. What we don't know for certain is whether poor sleep has long-term consequences on cognitive function," said William Thies, PhD, Alzheimer's Association chief medical and scientific officer.

"The studies presented today at AAIC suggest that cognitive health declines over the long term in some people with sleep problems. The good news is that tools already exist to monitor sleep duration and quality and to intervene to help return sleep patterns to normal. If we do this, there is the possibility that we may also help people preserve their cognitive health, but that needs to be tested," Thies added.

Too little and too much sleep are associated with lower cognition
Growing evidence suggests that sleep duration that is shorter or longer than the recommended seven hours per day may increase risk of cardiovascular disease and type 2 diabetes. However, little research has been conducted examining whether sleep duration influences cognition among older individuals.

Elizabeth Devore, ScD, of Brigham and Women's Hospital, Boston, and colleagues examined data for more than 15,000 participants in the Nurses' Health Study. All were age 70 or older at their first cognitive examination between 1995 and 2000. Follow-up cognitive assessments were conducted every other year for six years. Participants' daily sleep duration was categorized as less than or equal to five, six, seven, eight or greater than or equal to nine hours (seven hours per day was considered normal). Average sleep duration was self-reported in 1986 (when women were ages 40 to 65) and 2000 (when women were ages 54 to 79).

The scientists found that:
Participants who slept five hours per day or less had lower average cognition than those who slept seven hours per day.
Those who slept nine hours per day or more also had lower average cognition than those who slept seven hours per day.
Too little or too much sleep was cognitively equivalent to aging by two years.

When the researchers evaluated the effects of change in sleep duration from mid- to later- life, they observed that women whose sleep changed by two hours per day or more had worse cognitive function than those with no change in sleep duration, independent of their initial sleep duration.

To explore sleep duration in relation to an early biomarker of Alzheimer's, the scientists examined the association with plasma levels of a ratio of proteins indicative of Alzheimer's disease brain changes (beta amyloid 42/40 ratio), which was measured in a small subset of women who provided blood samples in 1999-2000. They found that sleep durations of more than seven or less than seven hours per day were associated with declining ratios of amyloid-beta 42/40 compared to sleep durations of seven hours per day.

"Our findings support the notion that extreme sleep durations and changes in sleep duration over time may contribute to cognitive decline and early Alzheimer's changes in older adults," Devore said. "The public health implications of these findings could be substantial, as they might lead to the eventual identification of sleep- and circadian- based strategies for reducing risk of cognitive impairment and Alzheimer's."

Sleep disorders, circadian disruptions associated with increased risk of cognitive impairment
As people age, they are more likely to develop problems with sleeping, such as insomnia, sleep apnea and disruptions in circadian rhythm. (Circadian rhythms are physical, mental and behavioral changes that follow a 24-hour cycle.) Whether these problems affect one's cognitive function or risk of developing mild cognitive impairment (MCI) or dementia is not definitively known.

"Studies that have explored the relationship between sleep and dementia are often cross sectional and depend on the participant's self-report rather than objective measures of sleep quality," said Kristine Yaffe, MD, of the University of California, San Francisco.

Instead, Yaffe and colleagues conducted a series of studies evaluating more than 1,300 older women (greater than or equal to 75) enrolled in a large multi-center study to investigate the relationship between objectively measured sleep quality (using actigraphy* and polysomnography**) and adverse cognitive outcomes.
*Actigraphy is a method of monitoring rest/activity cycles. A small sensor unit is worn, usually on the wrist, to measure gross motor activity. The unit continually records the movements it undergoes.
** Polysomnography, also known as a sleep study, is a comprehensive recording of the physical changes that occur during sleep. The PSG monitors many body functions including brain, eye movements, muscle activity or skeletal muscle activation, breathing functions, and heart rhythm.

Over five years, the researchers assessed cognitive function and clinical cognitive status (normal, MCI or dementia) and obtained objective measures of sleep parameters, including sleep apnea, nighttime wakefulness, total sleep time, and shifts in circadian rhythm.

The scientists found that:
–Participants with sleep-disordered breathing or sleep apnea had more than twice the odds of developing MCI or dementia over the five years compared with those who did not have sleep-disordered breathing.
–Women who developed a disruption of their circadian rhythm (delay in the acrophase) over the five years were at increased risk of developing MCI or dementia compared with individuals who did not.
–Participants with greater nighttime wakefulness were more likely to score worse on tests of global cognition and verbal fluency than those without it.

"We believe that these results indicate that the relationship between sleep disordered breathing and dementia may be connected to the decrease in oxygen associated with sleep apnea and not to disrupted patterns of sleep," Yaffe said.
"Overall, our findings support a relationship between sleep disturbances and cognitive decline in late age. They suggest that health practitioners should consider assessing older people with sleep disorders for changes in cognition," Yaffe said. "In addition, with additional long-term research, treatment of sleep disorders may be a promising method of delaying the development of MCI and dementia."

Sleep complaints and risk of cognitive decline in the elderly
Sleep quality and quantity often decrease as people age, but whether this is associated with risk of cognitive decline is a subject of ongoing investigation.
To better understand the potential relationship between sleep and cognitive decline, Dr. Claudine Berr of INSERM, Montpellier, France, and colleagues examined data from the French Three-City Study, an ongoing, long-term, multisite study of the relationship between vascular disease and dementia in community-dwelling individuals age 65 or older. Cognitive data were obtained at baseline and at two, four, and eight years' follow-up; an ancillary project gathered data on sleep complaints at baseline.

Researchers analyzed data from 4,894 nondemented study participants who had completed sleep questionnaires, had Mini Mental State Examination (MMSE) scores of greater than or equal to 24 at baseline, and for whom data from at least one follow-up evaluation was available. Cognitive decline was defined as a decrease of four or more points on the MMSE at the three follow-up points. Researchers analyzed data for each of the five subcomponents of insomnia: (1) poor sleep quality, (2) difficulty initiating sleep, (3) difficulty maintaining sleep, and (4) early morning awakening; and excessive daytime sleepiness.

They found that excessive daytime sleepiness, which was reported by 17.9 percent of participants, independently increased risk of cognitive decline. In contrast, difficulty maintaining sleep, reported by 63.5 percent of participants, was negatively associated with risk of cognitive decline.

"These results suggest that excessive daytime sleepiness may be an early predictor of cognitive decline and that sleep complaints should be adequately evaluated in older persons," said the study's researchers.

Abnormal circadian patterns found in people with dementia
The amyloid hypothesis of Alzheimer's suggests that increased production or decreased clearance of amyloid-beta protein ultimately culminates in Alzheimer's disease. Changes in detectable amyloid proteins ion the body, such as decreased cerebrospinal fluid (CSF) amyloid-beta 42, have been recognized as biomarkers for the disease. However, the dynamics of amyloid-beta concentrations over time are not well understood.

The amyloid hypothesis of Alzheimer's suggests that increased production or decreased clearance of amyloid-beta 42 protein ultimately contributes to Alzheimer's disease. Changes in detectable amyloid proteins in the body, such as decreased cerebrospinal fluid (CSF) amyloid-beta 42, have been recognized as biomarkers for the disease. However, the dynamics of amyloid-beta concentrations over time, and changes in these proteins over the course of a 24-hour day, are not well understood. These dynamic changes are important to understand because CSF biological markers that could represent early Alzheimer's-like changes in people not yet showing Alzheimer's dementia symptoms will need to be measured consistently and accurately. The time of day of measurement and changes with age are critical to this standardized accurate measurement.

Supporting the above-mentioned initial data, a study at Washington University School of Medicine, St. Louis, Missouri, including people with dementia, age-matched participants, and younger participants, found circadian patterns in CSF and plasma amyloid beta, and CSF amyloid precursor protein, all of which are associated with Alzheimer's disease.

Yafei Huang MD, PhD and colleagues obtained hourly CSF and plasma samples over a 36-hour study period in all three groups. They investigated dynamic patterns of key Alzheimer's-associated amyloid-beta variants (amyloid-beta 40 and amyloid-beta 42) in CSF and plasma, and amyloid precursor protein (APP). They then analyzed the effects of amyloidosis on circadian patterns, aging and correlations between CSF and plasma amyloid-beta.

Circadian patterns which were reflected in protein level changes over the course of a 36-hour period were observed in CSF and plasma amyloid-beta. CSF APP also demonstrated a circadian pattern. In addition, CSF APP-alpha, APP-beta, amyloid-beta 40, and amyloid-beta 42 were highly positively correlated in all participants without amyloidosis. However, in participants with amyloidosis, there is no correlation of amyloid-beta 42 to the other APP metabolites, suggesting that normal physiologic regulation of CSF amyloid-beta 42 is impaired in the presence of amyloidosis.

"Our study suggests amyloid proteins are dynamic and regulated in a circadian pattern that is part of the normal control of amyloid-beta concentrations. Regulatory mechanisms of these proteins may be altered with aging and amyloidosis," said Huang. "These findings support the idea of an active circadian regulation of beta-amyloid and may provide insight into the pathophysiological changes of Alzheimer's."

"These findings indicate that circadian rhythms and age should be studied further and better understood as research in CSF biological markers moves forward to ensure standardized, accurate measurements of key Alzheimer's proteins for future early detection of the disease," Thies added.

 

Life Extension Foundation Sponsors Magnesium Sulfate Study at University of Miami

Clinical trial will assess the effectiveness of an intravenous magnesium sulfate infusion in participants displaying symptoms of treatment resistant mild and moderate depression.

Fla.-based Life Extension Foundation, a pioneer in funding the latest anti-aging research and integrative health therapies, is sponsoring a study in conjunction with the research division at the University of Miami under the direction of John E. Lewis, associate professor of psychiatry and behavioral sciences, entitled A double blinded, randomized, placebo-controlled study of an IV infusion of Magnesium Sulfate vs. 5 percent Dextrose in a crossover design in male and female volunteers with treatment resistant depression. This study was placed on the ClinicalTrials.gov website and is currently recruiting for participants.

This clinical trial will assess the effectiveness of an intravenous magnesium sulfate infusion in participants who display symptoms of treatment resistant mild and moderate depression. Each of the 20 subjects will be randomized in a double-blinded fashion to receive either an intravenous infusion of magnesium sulfate or placebo containing 5 percent dextrose. This will be followed by a washout period and then crossover to receive the product that was not initially received.

"The magnesium deficient status will be determined via assessment of the magnesium level in the blood and urine before and after each infusion," says Dr. Steven Hirsh, Life Extension clinical research director of clinical research. "The effectiveness of the infusion will be determined through scores attained on a rating scale for depression as well as a patient health questionnaire for depression." A correlation will then be conducted with levels of magnesium and these scores.

For interviews with study authors, contact Sheldon Baker, Life Extension director of public relations at 954.202.7739 or 954.790.5512, or by email at SBaker@LifeExtension.com.