Only two of the three phases of research required for new drug treatments have been completed, however. At this point, it’s not clear whether the treatment will go on to receive federal approval.

The hormone treatment, called MDV3100, is being tested as a treatment for a disease known as castration-resistant prostate cancer, according to a report on the research, published online April 14 in The Lancet.

Prostate tumors need testosterone to grow. One treatment involves castration, possibly with additional drug treatment, to combat the body’s processing of testosterone.

Though the treatment kills some cancer cells, others remain alive but dormant, the researchers explained in a news release from the journal. And these cells can re-grow and survive without as much testosterone, thus becoming castration-resistant, they said.

For their study, Dr. Howard Scher of Memorial Sloan-Kettering Cancer Center in New York City and his colleagues tested the MDV3100 hormone treatment in 140 men in the United States with castration-resistant prostate cancer. The researchers gave varying doses, from 30 to 600 milligrams a day, to the men to find the maximum tolerable dose, which they determined to be 240 milligrams.

“We recorded encouraging anti-tumor activity with MDV3100 in patients with castration-resistant prostate cancer,” both before and after chemotherapy, the researchers wrote in their report.

The researchers have begun a third phase of testing in which they will compare the hormone treatment to a placebo to see if it helps men with advanced prostate cancer live longer.

SOURCE: The Lancet, news releas.

The U.S. Food and Drug Administration today announced the approval of the Esteem – an implanted hearing system used to treat moderate to severe sensorineural hearing loss, a type of permanent hearing loss.

Sensorineural hearing loss is usually caused by genetic factors or damage to the inner ear resulting from noise, viral infections, or aging. The results are reductions in perception of sounds and in the ability to understand speech.

This differs from conductive hearing loss, which occurs when sound waves cannot transmit well through the outer or middle ear or both. Medical or surgical treatment can often restore hearing in people with a conductive hearing loss, which can be caused by earwax, fluid in the middle ear space, or a punctured eardrum.

The Esteem system consists of external testing and programming instruments and three implantable components: a sound processor, sensor, and driver. The sensor senses vibrations from the eardrum and middle ear bones and converts these mechanical vibrations into electrical signals, which are then sent to the sound processor, which amplifies and filters the signal to compensate for the individual patient’s hearing loss. The driver converts the enhanced electrical signal back to vibrations, which are then transmitted into the inner ear where they are perceived as sound.

“The approval of Esteem provides patients with an option to alleviate their hearing loss by using a device with no readily visible external components,” said Jeffrey Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health.

The system is designed to alleviate the effects of hearing loss in patients ages 18 years and older. Other criteria for the device include: stable bilateral sensorineural hearing loss, a normally functioning Eustachian tube, and normal middle ear anatomy. A patient’s ability to understand speech using Esteem should be similar to that of conventional hearing aids.

In a multicenter clinical study of Esteem versus pre-implant hearing aids, 93 percent of Esteem recipients scored equal to or better than their pre-implant hearing aids on a speech intelligibility test. Seven percent scored less than with their pre-implant hearing aids, and 56 percent scored better than with their pre-implant hearing aids.

Seven percent of participants experienced facial paralysis, and 42 percent experienced taste disturbance, both of which are results of the surgical procedure necessary to implant the device. The majority of these adverse events resolved during the one-year study period.

As a condition of FDA approval, Esteem manufacturer, Envoy Medical Corporation of St. Paul, Minn., must conduct two post-approval studies. In one study, Envoy must continue to follow-up on 61 subjects from the original study for five years to study safety and effectiveness. Another study of 120 newly enrolled subjects will include an evaluation of the incidence of facial paralysis at one month after implantation, and evaluate the effectiveness of Esteem five years after implantation.

Researchers assessed fitness, cognitive function and brain structural changes in 21 women with relapsing-remitting multiple sclerosis (MS).

Patients who were classified as being highly fit performed much better on cognitive function tests than less-fit patients. MRI scans also showed that higher levels of fitness were associated with greater volume of gray matter, which is linked to vital brain processing skills, and less damage in parts of the brain where MS-related deterioration occurs.

“We found that aerobic fitness has a protective effect on parts of the brain that are most affected by multiple sclerosis,” study lead author Ruchika Shaurya Prakash, an assistant professor of psychology at Ohio State University, said in a news release. “As a result, these fitter patients actually show better performance on tasks that measure processing speed.”

The researchers also found that fitter MS patients showed less deterioration of brain white matter, which are fibers that connect gray matter areas.

The study findings were released online in advance of publication in an upcoming print issue of the journal Brain Research.

Previous research has shown that exercise promotes production of proteins called nerve growth factors, which play an important role in the growth and maintenance of neurons in the brain.

“Our hypothesis is that aerobic exercise enhances these nerve growth factors in MS patients, which increases the volume of the gray matter and increases the integrity of the white matter. As a result, there is an improvement in cognitive function,” Prakash said.

“For a long time, MS patients were told not to exercise because there was a fear it could exacerbate their symptoms. But we’re finding that if MS patients exercise in a controlled setting, it can actually help them with their cognitive function,” she added.

SOURCE: Ohio State University, news release.

The label for Norpramin (desipramine hydrochloride tablets USP) will also warn that seizures precede abnormal heart rhythms and death in some patients. The heart conditions include a family history of sudden death, abnormal heart rhythms, and heart conduction disturbances.

The company’s letter to FDA and health professionals also said an overdose of Norpramin has shown a higher death rate than overdoses of other tricyclic antidepressants.

The study found that the injuries occurred in middle-age people who showed no symptoms and had a healthy weight. They were more common and more severe in those who exercised more, although lower-impact activities such as swimming and cycling might actually be beneficial, according to the researchers.

The findings “speak to the importance of low-impact aerobic activity, especially in knees that are aging and may not be as resilient as they used to be,” said Dr. Joseph Guettler, an orthopedic surgeon and sports medicine specialist at William Beaumont Hospital in Bingham Farms, Mich.

The problem is that bone and cartilage in the knee can develop cracks and fissures that worsen over time, “much as a pothole or crack in the pavement can become significant as cars keep driving over that area,” said Guettler, who’s familiar with the study findings but didn’t take part in the research.

When people develop these sorts of problems, “we know that they’re going to have an increased risk for arthritis later on in life,” he said.

Osteoarthritis, the most common form of arthritis, develops when cartilage deteriorates in joints and causes bones to rub against each other.

In the study, radiologists examined MRI scans of the knees of 236 people who had enrolled in an osteoarthritis study. The participants, aged 45 to 55, included 136 women and 100 men. All participants completed questionnaires about their physical activity levels, which formed the basis for their assignment to high-, medium- or low-level activity groups.

The researchers then looked for links between levels of physical activity and the health of the participants’ knees. The findings were to be presented Monday in Chicago at the annual meeting of the Radiological Society of North America.

Those who engaged in high levels of physical activity — including such things as sports, exercise, yard work and housework — had the highest levels of injuries. The injuries included fluid buildup in bone marrow and lesions in cartilage and ligaments.

“This study and previous studies by our group suggest that high-impact, weight-bearing physical activity, such as running and jumping, may be worse for cartilage health,” the study’s co-author, Dr. Christoph Stehling, a research fellow in the radiology and biomedical imaging department at the University of California, San Francisco, said in a news release. “Conversely, low-impact activities, such as swimming and cycling, may protect diseased cartilage and prevent healthy cartilage from developing disease.”

Guettler, the Michigan surgeon, said that activities involving twisting, jumping and pivoting are especially hazardous. Don’t overdo it when it comes to activities like basketball and soccer, he advised.

Instead, consider alternatives like walking, swimming, biking, cross-country skiing and training on elliptical machines, he said.

The researchers’ next goal is to figure out whether low-impact and high-impact physical activity affect the progression of osteoarthritis differently, Stehling added.

People had the same success in keeping off the weight they’d lost after sharply cutting their calorie intake for 3 months if they followed a low-carb (also called high-protein) diet or a high-carbohydrate regimen for the following year, Dr. Elizabeth A. Delbridge of the Heidelberg Repatriation Hospital in Victoria and her colleagues found.

Some studies have suggested that high protein diets may be a more effective way to lose weight short-term than high carbohydrate diets, Delbridge and her team note in their report. But there’s less evidence on which approach might be better for helping people to keep off weight they’ve lost, and whether the two diets have different effects on heart health.

To investigate, Delbridge and her team assigned 141 men and women who’d completed the weight-loss phase of the diet to a year on a diet in which 30 percent of their calories came from protein, or one consisting of 15 percent protein. Both groups also were instructed to keep their fat intake below 30 percent of total calories, and to focus on reducing saturated fat.

The study participants had lost 16.5 kilograms (36.4 pounds), on average, and only regained 2 kilograms, or about four pounds, over the following year.

While all the study participants saw their blood pressure go down as they lost weight, average blood pressure went up in the high-carbohydrate group during the weight maintenance phase, but the high-protein dieters were able to sustain their blood pressure reduction.

While people found it easy to stick to the high protein diet, Delbridge and her team say, the low-protein dieters “struggled to consume the recommended amount of carbohydrate (55%) and to limit their protein intake to 15%.”

But the low protein group still managed to keep their protein intake at about 22 percent of their calories, significantly below the 30 percent maintained by the high-protein dieters. And there was no significant difference between the two groups in the amount of weight they kept off.

The findings show, the researchers conclude, that “free-living overweight and obese people” (as opposed to those studied in an inpatient clinic, for example) were able to stick with recommended diet and keep off the weight they had lost for 12 months.

Though a human application is a ways off, researchers say the technique could one day be used to treat severe erectile dysfunction in men.

“We were able to show the tissue was able to integrate and function in the long term, which means we can start planning clinical applications [in humans],” said Dr. Anthony Atala, director of the Institute for Regenerative Medicine at Wake Forest University Baptist Medical Center and senior author of the study. “Our hope is to be able to treat patients with many conditions, including congenital abnormalities of the penis, traumatic injuries, penile cancer and severe cases of erectile dysfunction that don’t benefit from drug treatments.”

The study is published in the Nov. 9 online edition of the Proceedings of the National Academy of Sciences.

The penis is a complex organ, with nerve, muscle and vascular cells all needing to work together to achieve and maintain an erection. During an erection, smooth muscle tissue relaxes, allowing blood to flow into the penis. Endothelial cells, which line blood vessels, trigger the process by releasing nitric oxide.

In the study, the researchers extracted smooth muscle cells and endothelial cells from the animals’ penises. The cells were then separated and grown in the laboratory on rod-shaped collagen scaffolds for support. The scaffold was placed in an incubator and nourished by fluids to mimic conditions inside the body, Atala said.

After the cells had matured, the scaffolding and the newly formed penile spongy tissue, called corpora cavernosa, was surgically implanted into the rabbits’ penises.

About a month later, the tissue began to reconstitute itself, forming new blood vessel structures necessary for proper functioning, while nerves from the existing penile tissue integrated into the new tissue. In time, Atala said, the collagen structure was reabsorbed, and the cells built their own collagen structure.

In the treated rabbits, tests showed that pressure inside the penis, a key component of an erection, was normal. Other tests showed that blood flow, response to nitric oxide, drainage of the blood after the erection and presence of sperm in the female vagina were also normal. The tissue engineering worked so well that four of 12 females were impregnated by the repaired rabbits, according to the study.

Dr. Andrew McCullough, director of male sexual health, fertility and microsurgery at NYU Langone Medical Center, said the results are promising.

“It has a long way to go, but the researchers have basically shown they can take cells from an organ, culture them, put them back in and have them be functional,” McCullough said. “This is especially impressive because the penis is an organ that’s a very sensitive hydraulic pump, so to speak. During an erection, blood has to flow into the organ. The organ then has to expand and then shut down the drainage so the blood doesn’t flow back out. And all of these things are very interrelated.”

Better treatments for erectile dysfunction are badly needed, McCullough added. About 35 percent of men don’t respond to impotence drugs, including Viagra, Cialis and Levitra. As men age, diabetes, high cholesterol and hypertension — all conditions that can affect male sexual function — can worsen, making the drugs less effective.

In previous research, the Wake Forest researchers engineered human bladders in the lab. In clinical trials, about 30 children and adults with congenital bladder abnormalities or bladder injuries who were treated with the engineered tissue showed normal or improved bladder function for nearly 10 years, Atala said. Other researchers have shown some success in clinical trials with transplanting windpipe tissue.

A survey of 40 stylists in the Columbus, Ohio-area found that most develop long-term relationships with their older clients, and these seniors tend to talk freely about their troubles — including those with family, health, depression and anxiety.

The hairstylists, in turn, told researchers that they thought they could do a good job recognizing symptoms of depression, dementia and self-neglect in their elderly clientele, although they don’t necessarily know what help to recommend in these situations.

According to the findings released online in advance of publication in an upcoming print issue of the Journal of Applied Gerontology, the stylists revealed that most do offer sympathy and encouragement to their clients, and they would even be willing to go as far as referring the person to a helpful community service. Unfortunately, less than half of those surveyed said they knew what these local services might be.

“It seems like a perfect set-up — stylists have access to older adults who may need someone to point them to the help they need. But at least this sample of stylists suggests they don’t know what services are out there to help these folks,” study co-author Keith Anderson, an assistant professor of social work at Ohio State University, said in a university news release.

Still, several have tried to offer advice to their clients and about one-quarter have attempted to convince a client to seek professional help at some time.

“While not expecting too much beyond the scope of their jobs, we may be able to help stylists direct elderly people in trouble to community services,” noted Anderson, who suggested salons be provided with brochures and other information about these services available to the elderly.

Anderson and colleagues conducted the study to test the popular notion of “salon therapy,” in which barbers and hairstylists offer sympathetic ears and act as world-weary counselors to clients who are under their care for long periods on a regular basis.

“Their older clients may sit in a chair for an hour or longer while they’re having their hair done, and this may happen once or twice a month. So stylists are in a good position to recognize when things change with a client, and when they may need help,” he said.

A national program to promote awareness of domestic violence, called “Cut It Out,” already helps hairstylists recognize when clients may be victims and how to help them. While a similar program could help stylists spot mental and physical health problems in seniors, the Ohio survey found that less than half of those polled showed interest in receiving such training.

“We can’t expect them to do everything, but our results suggest that most stylists care about their clients and would be willing to help them,” Anderson stated in the news release.

A survey of about 3,000 purchases from 115 restaurant chains in New York City found that servings of brewed coffee or tea average about 63 calories, even when some include milk and sugar. But get a blended beverage and you’re looking at 239 calories on average — 89 more than you’re likely to find in a can of soda.

A large ice-blended beverage, meanwhile, can reach 750 calories or more. At one coffee chain, 8 percent of the customers interviewed bought the largest size of a blended drink, which can boast 860 calories.

“The popularity of blended coffee beverages has grown in recent years,” Dr. Thomas Farley, New York City’s health commissioner, said in a news release from the city’s Health Department. “Unfortunately, many of these drinks are loaded with calories. Your afternoon pick-me-up may be weighing you down.”

Research suggests that 17 percent of U.S. adults buy one of these blended drinks each day.

What to do? Beverages such as coffee and tea can have fewer than 10 calories, although you might need to studiously ignore those sugar packets, the health department suggests. Low-fat or skim milk can help, too, as can getting a “small” size if the drink is sugar-sweetened and flavoring it yourself.

Female Pattern Hair Loss
Also known as Androgenetic Alopecia, Female Pattern Hair Loss affects between 40 and 50% of the female population. It is caused by the same hormone that causes Male Pattern Baldness – Dihydrotestosterone (DHT). Whereas men will eventually go bald, women tend to experience an all-over thinning. It is quite common, affecting 1 in 10 pre-menopausal women. After the menopause, the condition affects around 50% of women. Some women can see signs while in their 20s or even earlier. Hair loss can be highly distressing for women however stress can also exacerbate the shedding.