Post-menopausal Women - Ultra Low-dose Estrogen Shown To Be Safe

Thu, 28 Feb 2008 20:35:06 -0600

Estradiol delivered via a skin patch over two years has no harmful effect on cognitive abilities or health-related quality of life.

A study led by researchers at the San Francisco VA Medical Center has shown that extremely low doses of estrogen had no ill effects on the cognitive abilities or general health of older women over the course of two years.

"This is exciting. It shows that women can take estrogen safely," observes lead author Kristine Yaffe, MD, chief of geriatric psychiatry at SFVAMC and associate professor of psychiatry, neurology, and epidemiology at the University of California, San Francisco.

In 2004, study results from the Women's Health Initiative (WHI), a nationwide longitudinal study sponsored by the National Institutes of Health, indicated that estrogen was associated with an increased risk of dementia among women 65 and older, as well as with an increased risk of heart attack and stroke.

"Those results raised a lot of doubts about whether women should be taking estrogen at all," Yaffe notes.

The current study, published in the July 2006 issue of Archives of Neurology, looked specifically at the potential effects of estrogen on cognitive abilities and quality of life. A group of 417 post-menopausal women aged 60 to 80 were randomly assigned to receive a daily .014 milligram dose of either estradiol, a form of estrogen, or a placebo through a skin patch for two years. The women were given a battery of standardized cognitive tests and a test of health-related quality of life at the beginning of the study, after one year, and after two years.

At the end of the study, there was no difference between the two groups in either cognitive abilities or health-related quality of life.

"The results are very reassuring, because it suggests that women can use this patch without harm for two years," says Yaffe. "It would benefit their bones and might have a beneficial effect in terms of hot flashes."

A related study of the same group of women showed a significant increase in bone density, without adverse health effects, in the women who took estradiol compared to the women who took placebo. The current study was a pre-planned secondary investigation.

Yaffe speculates that the differences in health and cognition outcomes between these two studies and the WHI studies could be related to three factors: dose, type of estrogen, and means of delivery.

The women in the WHI studies received .625 milligrams per day of conjugated estrogen - a mixture of estrogen from several different sources - in pill form. In contrast, the women studied by Yaffe and her associates received a daily dose of estradiol - pure human estrogen - that was over 44 times smaller and delivered through a skin patch.

"The different between a patch and a pill is significant because medications taken in pill form are processed through the liver before they reach the bloodstream," explains Yaffe. "It's thought that estrogen in pill form might stimulate the liver to produce substances that can lead to clotting or other adverse side effects. With a patch, you bypass the liver and go straight to the blood."

Yaffe notes that since the WHI results were announced in 2004, "the field of estrogen research has been stymied. Hopefully, this study will start to turn the tide."

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Article adapted by Medical News Today from original press release.
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Coauthors of the study are Eric Vittinghoff, PhD, of UCSF; Kristine E. Ensrud, MD, MPH, of the University of Minnesota and the Minneapolis VA Medical Center; Karen C. Johnson, MD, MPH, of the University of Tennessee Health Sciences Center; Susan Diem, MD, MPH, of UM; Vladmir Hanes, MD, of Berlex, Inc.; and Deborah Grady, MD, MPH, of SFVAMC and UCSF.

The research was funded by Berlex, Inc., with partial support from the National Institute of Aging.

SFVAMC has the largest medical research program in the national VA system, with more than 200 research scientists, all of whom are faculty members at UCSF.

UCSF is a leading university that consistently defines health care worldwide by conducting advanced biomedical research, educating graduate students in the life sciences, and providing complex patient care.

Contact: Steve Tokar
University of California - San Francisco

Military Innovations A Critical Facet Of Texas A&M Health Science Center

Thu, 28 Feb 2008 20:24:37 -0600

The military has always been the backbone of American life. We recognize Memorial Day in May, Flag Day in June, Veterans Day in November and other observances year-round to show our patriotism and remember those who have served and even paid the ultimate price to maintain our freedom.

The budgetary costs alone of providing disability compensation benefits and medical care to the veterans from Iraq and Afghanistan during the course of their lives will be from $350 billion to $700 billion, according to a January Faculty Research Working Paper from the Harvard University John F. Kennedy School of Government. Overall, as of late last year, more than 1.4 million service members have been deployed to these two countries.

"The number of veterans who are returning home with injuries or disabilities is large and growing," the report states. "We have not paid careful enough attention, or devoted sufficient resources, to planning for how to take care of these men and women who have served the nation."

Fortunately, the Texas A&M Health Science Center is paying attention and devoting resources through several initiatives that will assist and better the lives of military personnel, now and in the future.

Dr. Allison Rice-Ficht, Regents Professor of molecular and cellular medicine and director of the Center for Microencapsulation and Drug Delivery (CMDD) at the HSC-College of Medicine, recently received a $2.6 million grant award toward creating a new method for vaccine delivery for U.S. military personnel.

Dr. Ficht and her colleagues will be working on the two-year project with the Military Infectious Disease Research Program, a component of the U.S. Army Medical Research and Materiel Command. It is their hope to have a prototype of the "pocket vaccine" ready for human testing at study end.

"Our study focuses on creating an improved vaccine delivery system that enhances performance of vaccines," Dr. Ficht said. "This system would make the vaccine stable at room temperature and suitable for oral consumption. These are two important factors that would allow the vaccine to be taken without medical personnel on-site."

When complete, the new vaccines currently being designed for the infectious diseases brucellosis and Q-fever will allow military members to carry capsules in their pockets for oral use in a crisis situation. While vaccines are immediately useful to military personnel, such products also may protect the general public in the future against deliberate release of harmful agents such as bacteria, viruses and toxins.

The CMDD is a multidisciplinary faculty group from five colleges with the capability to design and test sustained delivery of vaccines and pharmaceuticals. Ongoing research includes basic and applied microencapsulation technologies for biomedical use, controlled release drug delivery systems, non-biomedical applications in nanotechnology, and microcapsule products for petrochemical, agricultural and environmental control industries. Associate members include researchers from other universities, industry and NASA.

Also at the HSC-COM, Dr. Keith Young, associate professor of psychiatry and behavioral science and co-director of the Central Texas Veterans Health Care System Neuropsychiatry Research Program, recently received $3 million to fund post-traumatic stress disorder research (PTSD) at Veterans Affairs facilities in Temple and Waco.

Thirty-six percent of Iraq and Afghanistan veterans treated to-date an unprecedented number have been diagnosed with a mental health condition such as PTSD, acute depression, substance abuse and other conditions, notes the recent KSG Faculty Research Working Paper.

The project involves following 1,400 soldiers who have recently returned from Iraq and Afghanistan for one year to determine the link between an individual's resiliency to PTSD and his or her genetics. He also will continue to study how antidepressants affect PTSD resiliency.

Dr. Young, Dr. Paul Hicks, head of the Waco VA's mental health division, and Kathryn Kotrla, M.D., chair of psychiatry and behavioral science in the HSC-COM, met with U.S. Rep. Chet Edwards, D-Waco, in spring 2005 to discuss potential funding for PTSD research. Federal lawmakers approved $3 million for Dr. Young's program in late 2005, and he and his colleagues have been working with Congress, the Army and Department of Defense for the past year on satisfying all the requirements needed for releasing the funds.

"Right now, we have $3 million to start with, but I am hopeful that we will receive increased funding to continue to promote this area of research," Dr. Young said. "It's important that we keep searching for the root cause of PTSD and seek new treatments for our soldiers and veterans."

Dr. Young and his colleagues already have found the inheritance of a common serotonin transporter (SERT) gene variant is involved in enlargement of the pulvinar nucleus of the thalamus, which is used in interpreting threatening visual stimuli, facial expressions and fearful emotions. The enlarged pulvinar may enhance the brain's "automatic threat detection system," making some people more vulnerable when exposed to stress and trauma. This finding could explain why some people are more resilient and others more vulnerable to both depression and PTSD.

The $3 million Department of Defense grant to study the root cause of depression and PTSD, based at the HSC Neuropsychiatry Research Program of the Waco VA and at Baylor University in Waco, is expected to begin MRI, animal and genetic research in the next several months.

A related project led by Dr. Hicks and also funded by the Department of Defense to test treatments for PTSD at Fort Hood, Texas, is in the final stages of preparation. The Fort Hood Project will collect genetic material to be used by the group to study genetic effects on PTSD and depression treatment response.

The two projects are part of the VA's newly designated Center of Excellence for Mental Disorders/PTSD at Waco, established last year in response to the increased mental health needs of Iraq and Afghanistan veterans. Two new staff have joined the research program, and a third will be added in the coming months. The group is awaiting final approval from funding and oversight agencies before filling the remaining research positions and beginning research projects.

These HSC-COM efforts augment work by the HSC-Rural and Community Health Institute in creating a Trauma Registry and Research Database in collaboration with the U.S. Army Institute of Surgical Research and Altarum. Federal funding for the program was earmarked with assistance from Congressman Edwards.

With advances in battlefield medical care and personal armament for soldiers, survivability for injured soldiers is at an all-time high. However, many survivors are faced with recovering from severe traumatic injuries, and there is no methodology that can accurately assess the trauma being faced in today's conflicts, nor a soldier's treatment and recovery from those wounds over time. The Trauma Registry and Research Database is designed to fill this gap, as well as assist in rural trauma care.

In addition, for soldiers suffering from severe facial trauma on the battlefield, Mohammed Elsalanty, M.D., Ph.D., assistant research scientist in biomedical sciences at the HSC-Baylor College of Dentistry, has been awarded a patent for a bone transport reconstruction plate, a device used for reconstructing bone defects in the lower jaw.

These bone defects can be caused by blast injuries, gunshot wounds and tumor removal surgeries. Traditional treatment has involved harvesting a bone segment from the body, such as the hip, and stabilizing it across the defect with metal plates and screws. However, these procedures were lengthy with several complications.

The new bone transport reconstruction plate developed by Dr. Elsalanty helps reconstruct the defect by growing bone from the edges via a mechanism called distraction osteogenesis. It is much easier, and the quality of the new bone resembles those of the jaw bone, making jaw rehabilitation more efficient.

Dr. Elsalanty and Lynne Opperman, Ph.D., assistant professor of biomedical sciences at HSC-BCD, have received more than $1 million in National Institute of Dental and Craniofacial Research Small Business Technology Transfer Research (NIDCR STTR) funding to build and test prototypes of the device. They also have started a company called Craniotech ACR Devices, L.L.C., to begin the commercialization process.

As these studies, programs and technology progress, up-to-date comprehensive training is critical in handling ever-increasing hostile military situations, especially terrorism.

The HSC-Office of Homeland Security joined with the Orange County Sheriff's Office earlier this year to host two, two-day training programs that provided insight into suicide bombs and emergency preparedness. Training was given to advanced levels of government and security personnel, as well as security managers of government buildings, schools and safety officers, and law enforcement.

The program included common lectures, break-out groups and a Core Disaster Life Support (CDLS) course demonstrating the "know-how" about the typology, methodology motivation, preparation, bombs and techniques used. Methods used by Middle Eastern terror networks in recruiting, communication and employing terror attacks, lessons learned and experienced from recent suicide bombings, the importance of prevention, and how to detect attacks and respond safely to events that have bombs or bombers were covered.

At the HSC-School of Rural Public Health, Chris Johnson, Ph.D., associate professor of health policy and management, has a strong foundation in veterans' health services research and studies nursing homes and other types of healthcare organizations within various settings. A former captain in the Marine Corps, he is a 1987 graduate of the U.S. Naval Academy and a veteran of the First Persian Gulf War.

Dr. Johnson was in the first group ever awarded a Department of Veterans Affairs Merit Review Entry Program Career Development Award for non-clinical health services researchers. He has led and participated in grants funded by The Commonwealth Fund, Robert Wood Johnson Foundation, Agency for Healthcare Research and Quality, VA Health Services Research and Development Service, State of Florida Agency for Health Care Administration, Novartis and HealthGrades, Inc.

Among his work, Dr. Johnson presented results during the 2006 AcademyHealth Annual Research Meeting of a study of veterans whose care is paid for by the VA Community Nursing Home Program. He initially hypothesized that because of VA oversight, nursing homes with VA-covered residents maintain higher levels of multidimensional care than those without such residents.

Dr. Johnson found that facilities with any veterans were less likely to meet nurse staffing standards; more likely to have patients requiring tube feeding, new catheterizations and mobility restraints; and more likely to have "harm" citations and patients with new pressure sores, as well as quality-of-care, quality-of-life and total deficiencies than facilities without veterans. Among the facilities with veterans whose care is covered, those with higher proportions of VA residents were less likely to have patients with restraints, new pressure sores or an actual harm citation.

"These results raise some initial concerns about the quality of care for veterans within community nursing homes under the VA per-diem program," Dr. Johnson said. "However, additional VA oversight, as implied by a greater proportion of VA residents, may make a difference in terms of quality of care."

Dr. Johnson and colleagues at the VA Rehabilitation Outcomes Research Center of Excellence continue to study the impact of community and VA nursing homes on the provision of care to residents diagnosed with stroke. He has proposals under review with the National Institutes of Health and the VA, and his current focus is on increasing the capacity to review access of quality-of-care issues through epidemiological methods, economics cost analysis and health policy.

Alongside Dr. Johnson at the HSC-SRPH, Deborah del Junco, Ph.D., associate professor of epidemiology and biostatistics, has dedicated her life to improving veterans' health. Her passion for high quality veterans' health service, as well as research, stems from her parents meeting during their World War II service in the U.S. Marine Corps. She has a black-and-white framed photograph of her mother in uniform in her office and was raised with a strong sense of values supporting the role of both women and men in the U.S. Armed Forces.

To address concerns by women veterans that VA health research and health services were not keeping pace with the growing presence of women in the military, Dr. del Junco developed the U.S. National Registry of Women Veterans in 1997, with funding from the Department of Veterans Affairs. The registry has been used to support several national research initiatives to promote health-related research to benefit all women veterans and to improve gender-specific health services within the Veterans Health Administration.

Dr. del Junco currently is conducting research related to veterans' health issues and has completed several studies on the topic funded by the EPA, National Cancer Institute and VA.

These and other military initiatives by the Texas A&M Health Science Center are part of its ongoing investment to change people's lives across Texas, around the nation and throughout the world.

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College Station, TX 77843-1114
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http://tamhsc.edu

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Post-menopausal Women - Ultra Low-dose Estrogen Shown To Be Safe

Military Innovations A Critical Facet Of Texas A&M Health Science Center