U.S. Government Grants Awarded For Further Development Of Adult Stem Cell Products

Regenerative medicine company, Mesoblast Limited (ASX: MSB; USADR: MBLTY), announced that its United States associate company, Angioblast Systems, has been awarded $1.2 million in grants under the United States Government’s Qualifying Therapeutic Discovery Project (QTDP) program.

Angioblast received the maximum grant amount awarded for each of the five projects that were eligible for QTDP funding. The projects, selected jointly by the United States Treasury Department and the Department of Health and Human Services, relate to the company’s adult stem cell products for congestive heart failure, heart attack, oncology, eye and diabetes indications.

“We are pleased to have received this cash award, and will use the funds to advance our objectives for product commercialization,” said Mesoblast Chief Executive Professor Silviu Itescu.

The QTDP program was enacted as part of the Patient Protection and Affordable Care Act of 2010 to provide tax credits to eligible companies in order to encourage investments in new therapies for prevention or treatment of acute and chronic diseases. Companies, such as Angioblast Systems, that cannot currently use a tax credit were allowed to apply for a cash grant in lieu of a tax credit.

To be eligible for the program, projects had to show reasonable potential to result in new therapies to treat areas of unmet medical need, prevent, detect, or treat chronic or acute disease and conditions, or reduce long-term health care costs in the United States. Preference was given to projects that showed the greatest potential to create and sustain (directly or indirectly) high quality, high-paying jobs in the United States, and advance United States competitiveness in the fields of life, biological, and medical sciences.

“The award serves as further external recognition, in this case by the United States Government, of the strength and promise of our adult stem cell technology platform to deliver effective therapies for a range of conditions currently in great medical need,” said Professor Itescu.

Source: Mesoblast Limited

Risk For Stroke Temporarily Increases For An Hour After Drinking Alcohol

Call it the not-so-happy hour. The risk of stroke appears to double in the hour after consuming just one drink – be it wine, beer or hard liquor – according to a small multi-center study reported in Stroke: Journal of the American Heart Association.

“The impact of alcohol on your risk of ischemic stroke appears to depend on how much and how often you drink,” said Murray A. Mittleman, M.D., Dr.P.H., senior author of the Stroke Onset Study (SOS) and director of the Cardiovascular Epidemiology Research Unit at Beth Israel Deaconess Medical Center in the Harvard Medical School in Boston, Mass.

Prior to the SOS, researchers didn’t know if alcohol consumption had an immediate impact on ischemic stroke (caused by a blood clot in a vessel in or leading to the brain), although modest alcohol use (less than two drinks per day) may potentially lower risk in the long term.

Researchers interviewed 390 ischemic stroke patients (209 men, 181 women) about three days after their stroke regarding many aspects of their lives. Patients were excluded if the stroke seriously impaired their ability to speak or if they weren’t well enough to participate. Fourteen patients had consumed alcohol within one hour of stroke onset.

Compared with times when alcohol wasn’t being used, the relative risk of stroke after alcohol consumption was:
2.3 times higher in the first hour;
1.6 times higher in the second hour; and
30 percent lower than baseline after 24 hours.

The patterns remained the same whether participants had consumed wine, beer or distilled spirits. When the researchers eliminated patients who had been exposed to other potential triggers (such as exercising vigorously or drinking a caffeinated beverage) just prior to their strokes, the alcohol connection didn’t change. Only one participant had consumed more than two drinks in the hour preceding the stroke, and removing that data didn’t alter the pattern.

“The evidence on heavy drinking is consistent: Both in the long and short term it raises stroke risk,” Mittleman said. “But we’re finding it’s more complicated with light to moderate drinking. It is possible that the transiently increased stroke risk from moderate alcohol consumption may be outweighed by the longer term health benefits.”

Just after drinking, blood pressure rises and blood platelets become stickier, which may increase the possibility of a clot forming. However, consistent use of small amounts of alcohol is associated with beneficial changes in blood lipids and more flexible blood vessels, which may reduce risk overall.

“At this point we don’t have enough evidence to say that people who don’t drink should start, or that people who drink small amounts – on the order of one drink a day – should stop,” Mittleman said.

A more definitive answer would require a controlled study in which some people are randomly selected to consume alcohol while others don’t, he said.

The findings may not apply to patients with severe stroke.

Stroke is the No. 3 killer and a leading cause of long-term major disability in the United States, according to American Heart Association statistics.

The American Heart Association recommends that if you drink alcohol, do so in moderation. This means no more than two drinks per day for men and one drink per day for women. (A drink is one 12-ounce beer, 4 ounces of wine, 1.5 ounces of 80-proof spirits, or 1 ounce of 100-proof spirits.) High intakes can be associated with serious adverse effects and may increase alcoholism, high blood pressure, obesity, stroke, breast cancer, suicide and accidents. Consult your doctor on the benefits and risks of consuming alcohol in moderation.

Notes:
Co-authors are: Elizabeth Mostofsky, M.P.H.; Mary R. Burger, M.D.; Gottfried Schlaug, M.D., Ph.D.; Kenneth J. Mukamal, M.D., M.P.H.; and Wayne D. Rosamond, Ph.D.
Author disclosures are on the manuscript.
The study is supported by an American Heart Association grant.

Source:
American Heart Association

Can Charcoal Fight Heart Disease In Kidney Patients?

Charcoal may provide a new approach to managing the high rate of heart disease in patients with advanced kidney disease, according to preliminary research presented at the American Society of Nephrology’s 42nd Annual Meeting and Scientific Exposition in San Diego, CA.

Patients with advanced kidney disease have high rates of atherosclerosis (“hardening of the arteries”) and death from heart disease. Oral activated charcoal – a product called AST-120 – has traditionally been used as an emergency treatment for certain types of poisoning. Recent studies have suggested that AST-120 may exert beneficial effects in kidney disease.

“We found that oral activated charcoal lessens atherosclerotic lesions in experimental mice with kidney damage,” comments Valentina Kon, MD (Vanderbilt University). “This is especially important because there is no effective treatment to reduce the high rate of cardiovascular mortality in patients with end-stage renal disease.”

The researchers studied the effects of AST-120 in mice genetically engineered to develop atherosclerosis. The effects were assessed in mice with different levels of kidney mass.

In mice with profoundly reduced renal mass, treatment with AST-120 led to a dramatic decrease in atherosclerosis. This was so even when charcoal treatment was delayed. The improvement in atherosclerosis was unrelated to changes in blood pressure or cholesterol levels. Rather, the effect appeared related to reduced inflammation in the blood vessels.

In mice, oral activated charcoal appears to reduce atherosclerosis associated with kidney disease. The effect is present at different levels of kidney function, in very advanced atherosclerosis, and even when treatment is delayed. More research is needed to see if AST-120 offers similar benefits in humans with kidney disease.

The research was supported by Kureha Chemical Industry Co., Ltd., Tokyo, which makes AST-120.

Source: Shari Leventhal

American Society of Nephrology

MU Professor Finds Americans Are Hesitant To Support Global Environmental Efforts

Last week, British Prime Minister Gordon Brown declared climate change a top international threat, and Al Gore urged politicians to get involved to fight global warming. Results from a recent survey conducted by a University of Missouri professor reveal that the U.S. public, while aware of the deteriorating global environment, is concerned predominantly with local and national environmental issues.

“The survey’s core result is that people care about their communities and express the desire to see government action taken toward local and national issues,” said David Konisky, a policy research scholar with the Institute of Public Policy. “People are hesitant to support efforts concerning global issues even though they believe that environmental quality is poorer at the global level than at the local and national level. This is surprising given the media attention that global warming has recently received and reflects the division of opinion about the severity of climate change.”

Konisky, an assistant professor in the Truman School of Public Affairs at MU, recently surveyed 1,000 adults concerning their attitudes about the environment. The survey polled respondents about their levels of concern for the environment and preferences for government action to address a wide set of environmental issues.

A strong majority of the public expressed general concern about the environment. According to the survey, the top three issues that the public wants the government to address are protecting community drinking water, reducing pollution of U.S. rivers and lakes, and improving urban air pollution issues like smog. In the survey, global warming ranks eighth in importance.

“Americans are clearly most concerned about pollution issues that might affect their personal health, or the health of their families,” Konisky said.

Additionally, Konisky and his colleagues found that the best predictor of individuals’ environmental preferences is their political attributes. They examined the relationship between party identification and political ideology and support for action to address environmental problems.

“The survey reinforced the stark differences in people’s environmental attitudes, depending on their political leanings,” Konisky said. “Democrats and political liberals clearly express more desire for governmental action to address environmental problems. Republicans and ideological conservatives are much less enthusiastic about further government intervention.”

###

Results from the survey were recently presented at the annual meeting of the Western Political Science Association in San Diego. Click here for more on the survey.

Source: Emily Smith

University of Missouri-Columbia

New Report Underscores Need For Congressional Action To Limit Antibiotic Use In Animal Agriculture

A new report by the Pew
Commission on Industrial Farm Animal Production (pcifap) documents
the perils of antibiotic use in factory farms and the many strains of
antibiotic-resistant E-Coli, Salmonella, Camphylobacter,
methicillin-resistant Staphylococcus aureus (MRSA), and other bacteria that
these facilities cause.

The report release comes a few days after Tyson Foods and the U.S.
Department of Agriculture (USDA) agreed on a new label for their chickens
raised without antibiotics: “Chicken raised without antibiotics that impact
antibiotic resistance in humans.” Tyson announced in June, 2007, that it
would stop feeding antibiotics important in human medicine to their
chickens, a move that advocated hailed as “a great step forward.” But no
other large meat producers have followed suit.

“The added voice of the Pew Commissioners to that of the American
Medical Association and the Infectious Diseases Society of America shows
the need to stop factory farms from squandering the effectiveness of our
antibiotic supply,” said Richard Wood, Steering Committee Chair of the Keep
Antibiotics Working coalition. “But lasting change will only come when the
U.S. government decides to act. We hope that the Pew report will help spark
that step.”

The heavy use of antibiotics in industrialized livestock operations can
select for resistant bacteria, such as MRSA. The Union of Concerned
Scientists estimates that 70% of all the antibiotics and related drugs used
in the United States are used as feed additives for chicken, hogs, and beef
cattle. The new report details the many links between farm antibiotic use
and the spread of resistant infections in humans.

Despite a long awareness of the link between farm antibiotic use and
resistance in humans, the United States still allows the routine and
unnecessary use of critically important drugs in farm animals for growth
promotion. The United States also fails to adequately monitor antimicrobial
resistance in farm animals. Even the recent media coverage on MRSA being
found in Canadian and European livestock has not prompted the US to check
its own livestock to ensure food safety.

Proposed federal legislation would phase out the use of antibiotics
that are important in human medicine as animal feed additives within two
years. The Preservation of Antibiotics for Medical Treatment Act is
sponsored by Senate Health Committee Chairman Edward Kennedy (D-MA) and
Senators Olympia Snowe (R-ME), Susan Collins (R-ME), Sherrod Brown (D-OH)
and Jack Reed (D-RI) in the Senate (S. 549) and Rep. Louise Slaughter
(D-NY), the only microbiologist in Congress, and 34 other House members in
the U.S. House of Representatives (H.R. 962).

The Keep Antibiotics Working Coalition has recently highlighted a
half-dozen scientific studies that clearly demonstrate the escalating
health threat:

– Clinical Infectious Diseases published a study this month showing
that patients in a Dutch hospital who were exposed to pigs or veal calves
(mostly farmers) had 3-fold increase in risk for MRSA infections.

– The U.S. Centers for Disease Control and Prevention’s Emerging
Infectious Diseases published a study in December linking a new strain of
methicillin-resistant Staphylococcus aureus (MRSA) once found only in pigs
to more than 20 percent of all human MRSA infections in the Netherlands

– Veterinary Microbiology published a study in October that found MRSA
prevalent in Canadian pig farms and pig farmers, pointing to animal
agriculture as a source of the deadly bacteria.

– Applied and Environmental Microbiology published a study in August
that linked the routine use of the antibiotic tetracycline, popular in
swine production, to the presence of antibiotics resistance genes in
groundwater.

– Journal of Food Protection published a study in August by USDA
researchers showing that feeding chickens the antibiotic tylosin to promote
growth — not to treat disease — greatly increases the number of
erythromycin-resistant Campylobacter on chicken carcasses.

– Emerging Infectious Diseases published a study in 2006 documenting
U.S. veterinarians as carriers of MRSA. In a 2005 survey of attendees at an
international veterinary convention in Baltimore, MD, who were tested for
MRSA found that of the 27 who tested positive, 23 were from the United
States.

Keep Antibiotics Working Coalition
pcifap

Clinical Trial Shows 96% Improvement In Pressure Ulcer Healing Among Nursing Home Residents

Medical Nutrition USA,
Inc., (MDNU) announced today the results of a clinical trial on its
Pro-Stat(R) modular protein supplement. In the first clinical trial of its
kind, investigators found that the use of Pro-Stat(R), improves the healing of
pressure ulcers among long-term care residents by 96%.

Reported in the March 2006 issue of Advances in Skin & Wound Care, a
multidisciplinary peer-reviewed journal, the multi-state, randomized,
placebo-controlled trial covering 89 residents in 23 nursing homes studied the
healing rates of those receiving standard care plus Pro-Stat(R) liquid protein
supplement, compared with a control group receiving standard care plus a
placebo. Standard care for both groups included patient-appropriate topical
and pressure-relief treatments as well as enhanced foods and other
supplements, including some formulated for wound healing. While both groups
showed improvement, the amount of healing in the treatment group was
significantly greater than in the control group.

The incidence of pressure ulcers (bedsores) is a serious problem in long-
term care facilities, affecting as much as 23% of long-term care residents and
costing an estimated $1.3 billion in treatment costs annually. Pressure
ulcers are also one of the most common causes of litigation involving nursing
homes. Additionally, pressure ulcers have become a focus issue for Federal
and State health care facility regulators. After observing little improvement
in pressure ulcer incidence for more than 30 years, in 2000 the US Health and
Human Services department in its Healthy People 2010 initiative called for a
50% reduction in pressure ulcer incidence by 2010. In 2005, the Centers for
Medicare and Medicaid Services (CMS) issued new survey guidelines for the
assessment, treatment and prevention of pressure ulcers in nursing homes.

“Pressure ulcers represent a major cost for long-term care facilities in
terms of treatment and potential litigation. For the resident, they can be
life threatening and pose a significant lifestyle issue,” said S. Kwon Lee,
MD, FACS, a Cleveland physician and wound care specialist, and the principal
investigator for the study. “While nutritional supplements have long been
recommended to prevent or treat pressure ulcers, this is the first randomized,
controlled trial to actually show how much healing occurs with different
treatment regimens. I believe the findings will be very beneficial to nursing
home staff and wound care specialists because they provide more information on
how best to prevent and treat one of the most distressing and costly ailments
afflicting long term care residents.”

Defined as any lesion caused by unrelieved pressure resulting in damage to
the underlying tissue, pressure ulcers, often called bedsores, are primarily
caused by immobility and are particularly common among nursing home residents
many of whom experience nutritional deficiencies. Inadequate protein
metabolism impairs the body’s ability to form new skin tissue and heal wounds.
Pressure ulcers are often associated with insufficient turning and poor body
alignment while the resident is confined to bed. Long periods of sitting in
one position, such as in a wheelchair, can also cause the skin to breakdown.
Malnutrition, dehydration, repeated skin wetting and abrasions from sheets can
heighten the occurrence of pressure ulcers. A resident at risk can develop a
pressure ulcer within two to six hours of the onset of pressure, making timely
intervention critical.

“A pressure ulcer can form literally overnight, or in a matter of hours if
there is unrelenting pressure in a vulnerable area,” said Mary Jane Maloney, a
nurse practitioner and certified wound specialist, and a consultant to many
long-term care facilities in northeastern Ohio.

Pressure ulcers usually develop over bony prominences of the body in such
areas as the sacrum, hips, ankles, heels and toes and are classified into four
stages: Stage I — an observable redness of the skin; Stage II — an
observable thinning of the skin; Stage III — an observable thinning and skin
loss with damage to the underlying tissue appearing as a deep crater or
blister; and Stage IV — full skin loss with extensive damage to the skin and
underlying tissue, involving necrosis (rotting of the skin) and possible
damage to the muscle and bone
“In the later stages, the patient is much more susceptible to infection,”
said Maloney. “Patients with a deteriorating pressure ulcer usually develop
sepsis. An example is the actor Christopher Reeve, who died of sepsis
secondary from a large pressure ulcer.”

Usual treatment for pressure ulcers includes a range of moist wound
healing modalities, patient rotation and pressure relief, topical ointments,
and nutritional and/or protein supplementation.

“Data has long suggested that high protein diets improve the healing of
pressure ulcers, but specific evidence until now has been weak regarding how
much protein, and in what form, is most effective,” said Dr. Lee. “An easily
digested, easily consumed, concentrated, liquid protein, such as that used in
the study, makes it easier for residents to get the amount they need. The
results may also have been influenced by the fact that the study product is
hydrolyzed for rapid absorption and rich in the amino acids arginine,
glutamine and glycine, which have been found to improve wound healing.”

Pro-Stat(R), is manufactured by Medical Nutrition USA, Inc., Englewood,
NJ, and provides 15 grams of concentrated protein and 101 calories in one
fluid ounce.

A total of 89 residents with 132 total Stage II, III or IV pressure ulcers
in 23 nursing homes in New York, New Jersey, Ohio and Indiana were included in
the eight-week study. The treatment group received 1.5 ounces of Pro-Stat(R)
three times daily.

A conference call will be held on Tuesday, March 14, 2006 at 2:00 PM EST
with the authors of the study. The call may be accessed by calling
1-877-407-6180 prior to the conference. Replays of the call will also be
available on the pro-stat website until June 14, 2006 in the
Investor Relations section.

FACTS/FIGURES ABOUT PRESSURE ULCERS

The Incidence and Cost

* It has been estimated that as many as 23.9% of residents in skilled
care and nursing home facilities develop pressure ulcers at some time
(The National Pressure Ulcer Advisory Panel; The Agency for Health
Care Policy and Research)

* In high-risk patients, including elderly individuals with femoral
fractures and/or hip fractures, the incidence and prevalence is over
60% (The National Pressure Ulcer Advisory Panel, Agency for Health Care
Policy and Research)

* In addition, an estimated 9% to 13% of patients admitted to acute care
hospitals develop pressure ulcers. (J Advance Nursing)

* 1.8 million American are annually afflicted with pressure ulcers at a
treatment cost of $1.3 billion (The National Pressure Ulcer Advisory
Panel)

* 95% of pressure ulcers occur on the lower part of the body, 36% of
which are on the sacrum (lower back) and 30% on the heel. (Advanced
Wound Care; National Symposium on the Care, Treatment and Prevention of
Decubitus Ulcers)

* 8% of all deaths in nursing homes are attributed to pressure ulcers (J
Chronic Disease)

* 70% occur in people 70 years and older (Lancet)

* A resident at risk can develop a pressure ulcer within 2-6 hours of
the onset of pressure

Litigation

* More than 17,000 lawsuits are related to pressure ulcers annually, the
second most common claim after wrongful death and greater than falls or
emotional distress (Leila C. Knox 2004; Mayo Foundation for Education
and Research)

* Individual settlements range from under $50,000 to as much as $4
million (Mayo Clinic Rochester Geriatric Medicine, Community Internal
Medicine Division)

* In 28 out of 30 plaintiff verdicts/settlements in pressure ulcer
lawsuits, the average compensation was just under $1 million. (Rowe
1999)

Initiatives

* In 2000, the US Health and Human Services Department’s Healthy People
2010 initiative established a goal of reducing the proportion of
nursing home residents with pressure ulcers by 50% by 2010.

* In 2005, US Centers for Medicare/Medicaid Services (CMS) issued updated
guidance for surveyors regarding F Tag 314/Pressure Ulcers.

Medical Nutrition USA, Inc.
pro-stat

Muscle-Derived Stem Cells Prove Effective In Reparing Sphincter Damage To Restore Continence

Transplantation of muscle-derived stem cells may provide a safe and effective treatment for patients suffering from urinary incontinence following a surgical procedure. Two studies presented at the 103rd Annual Scientific Meeting of the American Urological Association (AUA), show that patients with incontinence resulting from iatrogenic sphincter damage may benefit from this therapy. Researchers from Germany and Austria present findings from two studies to reporters in special press conferences on May 20, 2008 at 1:00 p.m. and 1:30 p.m.

Certain medical procedures, including transurethral resection of the prostate and radical prostatectomy can result in damage to the external urinary sphincter. In one study, a German research team successfully implanted muscle cells grown from tissue from the patients’ deltoid muscles into the damaged sphincter. One year later, four patients were completely continent and 19 patients had improved from grade III to grade I incontinence. With more than half of the patients experiencing an improvement in continence after four months, the use of muscle-derived cells to repair sphincter damage proved successful. Minor side effects were observed in five patients.

A second study reaffirmed these findings. Using muscle cells from the upper arms of 65 incontinent men who had undergone a prostatectomy, researchers in Austria grew the cells in a laboratory and then implanted them. Patients were evaluated before the surgery to define their level of incontinence and evaluated post-operatively to monitor complications. Prior to therapy, the mean number of pads used per day was 4.89, and after treatment, the mean number of pads decreased to 1.59. 27.9 percent of patients did not wear pads at all and 43.6 percent reported that they only required a pad for “special occasions.” Only 28.5 percent of patients still required pads.

###

Otto T, Eimer C, Gerullis H: Repair of iatrogenic sphincter damage and urinary incontinence by autologous skeletal muscle derived cells (MDC). J Urol, suppl., 2008; 179: 484, abstract 1414.

Strasser H, Mitterberger M, Dalpiaz O, Kerschbaumer A, Pinggera GM, Frauscher F et al: Transurethral ultrasound guided injection of autologous myo- and fibroblasts in treatment of incontinence in men: 2 year data. J Urol, suppl., 2008; 179: 483, abstract 1413.

About the American Urological Association: Founded in 1902 and headquartered near Baltimore, Maryland, the American Urological Association is the pre-eminent professional organization for urologists, with more than 15,000 members throughout the world. An educational nonprofit organization, the AUA pursues its mission of fostering the highest standards of urologic care by carrying out a wide variety of programs members and their patients, including UrologyHealth, an award-winning on-line patient education resource, and the American Urological Association Foundation, Inc.

Source: Lacey Holt

American Urological Association

Little Evidence That Treating Varicoceles In Men Boosts Pregnancy Rates

A recent review of studies from the Netherlands finds no evidence that treating varicoceles a somewhat common condition in men with fertility problems improves a couple’s chances of conceiving a baby.

However, a U.S. commentator questions the review’s study selection and the way it defines infertility.

Fertility experts have long thought that varicoceles, an enlarged group of veins within the scrotum, could be a cause of male fertility problems. Varicoceles occur in 15 percent of all men, and in nearly 40 percent of men undergoing infertility treatment.

Surgery or embolization a procedure that blocks blood supply to the varicoceles is often performed in an effort to increase fertility.

“Every year thousands of men are operated on without sufficient scientific evidence that the surgery will have any impact,” said Johannes Evers, the lead review author. “There have been dozens of observational studies published showing a positive effect. However, high-quality, randomized trials were not able to confirm these positive conclusions.”

The review included eight studies involving 607 men. In addition to the presence of a varicocele, study authors looked at other fertility indicators such as quantity and quality of the man’s semen. Pregnancy and live birth were the main outcomes measured. Treatment was either by surgical removal of the varicocele or embolization, where a surgeon inserts a small coil or scarring agent into the vein to block it off.

“This review fails to offer evidence that treatment of varicoceles in men from couples with otherwise unexplained subfertility improves the couple’s chances of pregnancy,” Evers said. “Treatment of varicoceles in men cannot be recommended. The ‘first, do no harm’ principal should guide us as long as there is no evidence to the contrary.”

Evers is a professor of obstetrics and gynecology at Academisch Ziekenhuis in Maastricht a city in the Netherlands.

The review appears in the latest issue of the Cochrane Library is a publication of The Cochrane Collaboration, an international organization that evaluates medical research. Systematic reviews draw evidence-based conclusions about medical practice after considering both the content and quality of existing medical trials on a topic.

“My suggestion for patients is to check for other factors that might impair fertility before treating the varicocele,” Evers said. “Varicoceles do not seem to decrease fertility, or at least removing them doesn’t seem to help. Don’t concentrate on the wrong issue when there are other more important fertility factors present.”

Joel Marmar, M.D., a professor of urology at the Robert Wood Johnson Medical School in Camden, New Jersey is concerned that what he calls a “clinical hodgepodge of therapy” makes the results of the review confusing.

“Not everyone with a varicocele is going to be infertile,” Marmar said. “Treatment guidelines the American Urological Association and The American Society of Reproductive Medicine suggest that only those with a varicocele that the physician could feel (palpable) and a documented sperm abnormality should be treated. This review had studies that included men with normal semen parameters and very small or subclinical varicoceles.”

Using the more stringent guideline criteria for infertility makes a difference, Marmar said.

“Looking at all eight [review] studies, the odds ratio that treatment would be successful was 1.1 [indicating no benefit from the treatment],” he said. However, the results changed when the reviewers looked at a subset of three studies that met guideline criteria, Marmar said. “When including only those men who had palpable varicoceles and semen abnormalities, the odds ratio doubled. These improved results were reported despite a variety of therapies being used.”

Including both surgery and embolization in the analysis further confused the outcomes as they related to treatment of fertility issues, according to Marmar: “These techniques may have different success and failure rates. When developing a study design, it may not be appropriate to mix treatment options together.”

The Cochrane Collaboration is an international nonprofit, independent organization that produces and disseminates systematic reviews of health care interventions and promotes the search for evidence in the form of clinical trials and other studies of interventions. Visit cochrane for more information.

Evers JLH, Collins J, Clarke J. Surgery or embolization for varicoceles in subfertile men. Cochrane Database of Systematic Reviews. Issue 3. 2008.

Health Behavior News Service
Center for the Advancement of Health 2000 Florida Ave. NW, Ste 210
Washington, DC 20009
United States
hbns

Risk factors for a common knee injury among athletes

The US Army, Navy and Air Force academies – fierce rivals on the sports field – soon will cooperate on a $2.8-million
study of risk factors for a common knee injury among athletes.

The study, led by researchers at the University of North Carolina at Chapel Hill Injury Prevention Research Center, Duke
University and Andrews Air Force Base, will enroll 4,800 male and female cadets during a four-year period, beginning at their
summer entry into the academies.

The prospective cohort study will focus on human movement risk factors involved in injuries to the knee’s anterior cruciate
ligament, or ACL. The ACL is one of two ligaments that cross within the knee joint to prevent the leg bone (tibia) and
thighbone (femur) from slipping forward or backward out of the joint. Most ACL injuries are sports-related, and most occur
when there is no direct physical contact between athletes.

Studies have shown that the injury rate to the knee’s ACL is up to eight times higher for women than it is for men,
particularly in sports requiring stopping and jumping tasks, as in basketball, soccer and volleyball. Such injuries often
require surgery and prolonged rehabilitation.

The study findings will offer a basis for shaping effective ACL injury prevention training programs for individuals engaged
in vigorous physical activity, including male and female athletes.

“This is the largest prospective cohort study put in place to address risk factors for ACL injury,” said the study’s
principal investigator, Dr. Stephen W. Marshall, who is an assistant professor of epidemiology at UNC’s School of Public
Health and assistant professor of orthopedics at UNC’s School of Medicine.

He also is co-chief of biostatistical services at the Injury Prevention Research Center, which is hosting the study.

“The study promises to give us exciting new information based on science that can be used to refine existing ACL injury
prevention programs. It will help define what aspects of human movement may predispose an individual to be at greatest risk
for ACL injury and how to lower that risk,” Marshall said.

Findings from earlier biomechanical studies at UNC and elsewhere indicate that the increased risk for ACL injury in women may
be largely due to neuromuscular factors such as muscle strength and human movement. These gender differences “are
particularly evident in the landing phase of a jump,” Marshall said. “We therefore propose that poor technique when landing
from a jump may be a useful marker of neuromuscular factors associated with an increased risk for ACL injury.”

Maj. Anthony I. Beutler, director of sports medicine at Andrews Air Force Base’s Malcolm Grow Medical Center, coordinates
activities involving two of the three military sites in the study. Dr. Darin Padua, assistant professor in UNC’s department
of exercise and sport science, designed and supervises the physical testing component of the baseline data collection
protocol.

Dr. William E. Garrett Jr., professor of orthopedic surgery at Duke University and renowned for his expertise in ACL injury
and sports medicine, is a consultant to the study.

Upon entry into the study, academy cadets will complete a baseline questionnaire that collects basic demographic data, as
well as information on their injury history and recent sports participation. In addition, participants will complete motion
analysis, muscle strength tests and postural alignment assessments.

The performance task used in the motion analysis protocol is a simple jump from a 12-inch box to the floor. This is a
standardized jump-landing task designed to simulate the forces on the ACL during vigorous physical activity. The study
participant jumps down from the elevated take-off box and lands on a force plate. He or she then immediately jumps vertically
as high as possible.

The force plate and a transmitter, in combination with sensors worn by the participant, will provide data on kinematics (body
motion) and kinetics (forces affecting motion) of the lower limb. Two cameras will record the jump so that a standardized
tool for scoring poor jump-landing technique can help analyze the jump from video replay at a later date.

Other risk factors, including demographic, hormonal and anatomical, also will be examined, as will a comparison of elements
that determine poor jump-landing technique between women and men and its prevalence.

Preliminary findings based on 118 U.S. Naval Academy study participants showed one sustained ACL injury during their first
year of follow-up (summer 2003-June 2004).

“Ultimately, this research will make a significant contribution to our understanding of the causes of ACL injury, with
particular regard to those risk factors that appear to predispose women to those injuries,” Marshall said.

The study’s feasibility is due largely to the opportunity to enroll a large number of very physically active men and women
and to readily track over time any ACL injuries that may occur, as these will be treated in the central orthopedics
department of each service academy, he added.

“This study provides a way for the Army, Navy and Air Force to come together and do good science. Competition between the
service academies is healthy, but cooperation is also part of the game.”

Along with Marshall and Padua, UNC researchers include Drs. Bing Yu, associate professor of allied health sciences in the
School of Medicine; Kevin M. Guskiewicz, professor of exercise and sport science in the College of Arts and Sciences;
Shrikant I. Bangdiwala, research professor of biostatistics in the School of Public Health; Kelly Evenson, research associate
professor of epidemiology in the School of Public Health; and Susan H. Wolf, research associate in the department of
epidemiology.

At the military study sites, in addition to Buetler, are, from the U.S. Naval Academy, Cmdr. Scott Pyne, Cmdr. David Keblish
and Greg Calhoon; from the U.S. Air Force Academy, Maj. John Tokish and Maj. Timothy Mazzola; and from the U.S. Military
Academy at West Point, Col. Dean Taylor, Dr. Sally Mountcastle, Lt. Col. Tom DeBerardino, Lt. Col. Bradley Nelson and Lt.
Col. Paul Stoneman.

Affiliated investigators at other institutions, in addition to Garrett, include Dr. Barry Boden of the Orthopedics Center in
Rockville, Md.; Dr. James Onate of Old Dominion University; Drs. Brent Arnold and Scott Ross of Virginia Commonwealth
University; Dr. Marjorie King of Plymouth State University; Dr. Alison Toth of Duke Sports Medicine Center; and Dr. Donald
Kirkendall, a private consultant.

Funding for the study comes from the National Institute of Arthritis and Musculoskeletal and Skin Diseases, a component of
the NIH. The American Orthopedic Society for Sports Medicine provided funds for a preliminary pilot investigation conducted
in 2003-2004.

By LESLIE H. LANG
UNC School of Medicine

Note: Contact Marshall at (919) 966-1320 or smarshallunc.edu. To view a photo of a jump-landing task in pilot data
collection at the U.S. Naval Academy, click on unc.edu/news/pics/other/acl040505.jpg

School of Medicine contact: Les Lang, (919) 843-9687 or llangmed.unc.edu

Contact: L.H. Lang
llangmed.unc.edu
919-843-9687
University of North Carolina School of Medicine
med.unc.edu

Women With Severe PMS Perceive Their Sleep Quality To Be Poor

Women with severe premenstrual syndrome (PMS) perceive their sleep quality to be poorer in association with their symptoms in the late luteal (premenstrual) phase, despite there being no specific alterations in sleep structure associated with premenstrual symptoms.

The study, authored by Fiona C. Baker, PhD, of the Human Sleep Research Program at SRI International in Menlo Park, Calif., and the University of the Witwatersrand in Johannesburg, South Africa, focused on nine women with PMS or premenstrual dysphoric disorder (PMDD) and 12 controls. The subjects, all 18-40 years of age, had laboratory-based polysomnographic recordings at two phases of the menstrual cycle: follicular phase and late luteal phase.

According to the results, women with severe PMS reported a significantly poorer subjective sleep quality during the late luteal phase, but there was no evidence of disturbed sleep based on the polysomnogram specific to premenstrual symptom expression. Both groups of women had increased wakefulness after sleep onset and increased sigma power in the late luteal phase compared with the follicular phase.

There were, however, some group differences in electroencephalographic measures regardless of menstrual phase, including decreased delta incidence and increase theta incidence and amplitude in women with PMS, suggesting the possibility of sleep electroencephalogram trait markers in women with PMS.

“Women with PMS or PMDD commonly report sleep disturbances, but the few studies using conventional polysomnographic measures have produced conflicting results. In this study, we investigated sleep quality and sleep composition using conventional and quantitative electroencephalographic analyses in women with severe PMS, as compared to that of controls,” said Dr. Baker.

Sleep plays a vital role in promoting a woman’s health and well being. Getting the sleep that you need is likely to enhance your overall quality of life. Yet, women face many potential barriers that can disrupt and disturb their sleep. Overcoming these challenges can help them enjoy the daily benefits of feeling alert and well rested.

Experts suggest that most women need about seven to eight hours of sleep each night.

Compared to men, there are many differences in how women sleep. In general, women tend to sleep more than men, going to bed and falling asleep earlier. A woman’s sleep also tends to be lighter and more easily disturbed. Women are more likely to feel unrefreshed even after a full night of sleep.

There are many complex factors that may affect how a woman sleeps. Some of these factors change over time. For example, excessive daytime sleepiness is more common when women are in their 20s and 30s. In contrast, older women appear to adapt better to periods of sleep loss. This difference has been attributed to the many commitments that compete for a young woman’s time. In particular, working moms must balance the demands of their career, family, friends and personal health needs.

Common factors that affect a woman’s sleep include:

- Life events
- Depression
- Illness
- Bad sleep habits
- Medication use
- Physical or hormonal changes

Millions of women suffer from an ongoing sleep disorder. These problems often remain undiagnosed.

SLEEP is the official journal of the Associated Professional Sleep Societies, LLC, a joint venture of the American Academy of Sleep Medicine (AASM) and the Sleep Research Society.

SleepEducation, a Web site maintained by the AASM, provides information about various sleep disorders, the forms of treatment available, recent news on the topic of sleep, sleep studies that have been conducted and a listing of sleep facilities.

American Academy of Sleep Medicine