Flibanserin for female arousal?

Flibanserin the female Viagra?

After three separate clinical trials, University of North Carolina (UNC) researchers say a drug (flibanserin) originally created as an antidepressant is effective at treating with acquired hypoactive sexual desire disorder.

The trials were the first ever to test a therapy that works at the level of the brain to enhance libido in women reporting low sexual desire, said UNC's John M. Thorp Jr., the principal investigator for North America in the studies. The results reported yesterday at the Congress of the European Society for Sexual Medicine in Lyon, France.

"Flibanserin was a poor antidepressant," Thorp explained. "However, astute observers noted that it increased libido in laboratory animals and human subjects. So, we conducted multiple clinical trials and the women in our studies who took it for hypoactive sexual desire disorder reported significant improvements in sexual desire and satisfactory sexual experiences. It's essentially a Viagra-like drug for women in that diminished desire or libido is the most common feminine sexual problem."

The trials measured changes from baseline on the following variables as reported by the women each week: number of satisfying sexual events, desire score, female sexual function index, female sexual distress and desire/libido.

The researchers say that treatment with 100 milligrams of flibanserin once a day was associated with significant improvements in the number of satisfying sexual events reported, sexual desire and a reduction in distress associated with sexual dysfunction.

"These results point to a novel approach to pharmacologic treatment of the sexual problem that plagues reproductive age women the most, and may over time prove to be an effective treatment without the side effects of androgen replacement therapy, which is the only treatment currently available," Thorp said. Flibanserin is currently only available to women taking part in clinical trials.

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LibiGel® Women's Viagra?

LibiGel®


LibiGel® is a gel formulation of testosterone, designed to be quickly absorbed through the skin after a once-daily application on the upper arm, delivering testosterone to the bloodstream evenly over time and in a non-invasive and painless manner. The topical application of LibiGel has the added advantage of reduced skin reactions compared to other forms of transdermal delivery systems (i.e. patches).

The concept behind the LibiGel® development program is intriguing – to develop a product to treat women who suffer from female sexual dysfunction for which there is no clinically tested, FDA approved product, and do this with a drug that will be shown to be safe and effective, and affordable, both to develop and for women to use. The LibiGel development program has been designed to show that LibiGel can safely improve women's sexual desire and the frequency of satisfying sexual events and decrease personal distress associated with low sexual desire in women with hypoactive sexual desire disorder (HSDD). LibiGel could be the first FDA approved product to treat FSD, specifically HSDD in menopausal women.

Though generally characterized as a male hormone, testosterone also is present in women and its deficiency has been found to decrease libido or sex drive. In addition to increasing sexual desire and activity and decreasing sexual distress, studies have shown that testosterone therapy can increase bone density, raise energy levels and improve mood. The goal of testosterone treatment of women complaining of HSDD is to increase the serum testosterone towards the normal range of premenopausal women in an effort to alleviate the symptoms of this disorder.

Development / Regulatory Status

Results of Phase II
Treatment with LibiGel in BioSante's Phase II clinical trial significantly increased satisfying sexual events in surgically menopausal women suffering from FSD. The Phase II trial results showed LibiGel significantly increased the number of satisfying sexual events by 238% versus baseline (p<0.0001);>

Progress and Plans in Phase III
On January 24, 2008, the US FDA notified BioSante that it had completed and reached agreement with BioSante on a Special Protocol Assessment (SPA) for BioSante's Phase III safety and efficacy clinical trials of LibiGel in the treatment of HSDD. This action confirms FDA's position that FSD and HSDD are true conditions that women experience with measurable endpoints that can be evaluated and which deserve therapeutic options. The SPA process and agreement affirms that the FDA agrees that the LibiGel Phase III safety and efficacy clinical trial design, clinical endpoints, sample size, planned conduct and statistical analyses are acceptable to support regulatory approval. Further, it provides assurance that these agreed measures will serve as the basis for regulatory review and the decision by the FDA to approve a new drug application (NDA) for LibiGel. Both Phase III safety and efficacy trials are underway and are double-blind, placebo-controlled trials that will enroll approximately 500 surgically menopausal women each for six-months of treatment.

The last issue beyond efficacy has been the question of safety of testosterone therapy in women, even though there are no data to indicate that low dose testosterone causes any serious adverse events in women. BioSante agrees with the FDA's efforts to ensure the safety of drugs in development and on the market, and has worked with the FDA to develop a program for LibiGel that is scientifically sound, affordable and realistic. BioSante is in agreement with the FDA for a clearly defined LibiGel development path that can lead to the approval of LibiGel for the treatment of FSD. Therefore, in addition to the two Phase III safety and efficacy trials described above, BioSante is conducting one Phase III cardiovascular safety study of LibiGel, which also is underway. The safety study is a randomized, double-blind, placebo-controlled, multi-center, cardiovascular events driven study of between 2,400 and 3,100 women exposed to LibiGel or placebo for 12 months. At the end of 12 months, BioSante intends to submit a LibiGel NDA for review and possible approval by FDA. BioSante will continue to follow the women enrolled in the safety study for an additional four years after the NDA submission and possible approval of LibiGel.

The LibiGel safety study is tracking a composite of cardiovascular events including cardiovascular death, myocardial infarction and stroke in women with FSD who are 50 years of age or older and have at least one of a number of cardiovascular risk factors such as hypertension and diabetes. The objective of the safety study is to show the relative safety of testosterone compared to placebo in the number of cardiovascular events. The incidence of breast cancer is also being tracked throughout the study.

Clearly, it will be the safety trial that drives the NDA timeline. BioSante believes it will take approximately 12 months to enroll the women in this multi-national cardiovascular-events-driven safety trial. Therefore, BioSante expects to be able to submit the LibiGel NDA for a potential approval and launch in 2011.


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Papaya: Natural Cure Against Cancer

Fresh research has revealed that the papaya plant and its extracts can provide protection against cancer by slowing the growth of cancerous cells without causing harmful side effects. The discovery has been made by a University of Florida researcher in a joint project with the University of Tokyo.

The research was published in Journal of Ethnopharmacology*. University of Florida researcher, the Vietnamese Dr. Nam Dang, conducted a research project with colleagues from the University of Tokyo and their findings indicate that extracts from the papaya plant affect the regulation of the immune system. In this way, the attack on the cancerous cells does not cause harmful side effects because it acts through boosting the immune system and therefore does not have any effect upon normal cells.

Dr. Dang’s research studied the application of the papaya plant for cures in patients suffering from cancer among indigenous communities in Vietnam and Australia. He then developed four strengths of extract from the papaya leaf, which when applied clinically, slowed the growth of cancerous cells in ten different types of cancer, namely those affecting the cervix, the breast, the liver, the lungs and the pancreas. The effects were visible within 24 hours.

While the research project concentrates on the application of the papaya leaf on cancerous cases in Asia, indigenous populations in Brazil have been using the papaya leaf for thousands of years in infusions to treat ailments of the liver, including hepatitis A. The research conducted by Dr. Dang was made using dried papaya leaves.

He proved that papaya leaf extract increases the level of signalling molecules which help to regulate the immune system, attacking the cancerous cells. By boosting the Th1-type cytokines, the immune system responds to invaders while not producing toxic effects on healthy cells.

This type of treatment, according to Dr. Dang, produces results which go hand in hand with reports from indigenous communities in Australia and Vietnam.

* Source http://enervon.com/tag/journal-of-ethnopharmacology/

Every Man Should Train His Prostate Daily

There are plenty of myths about the harm of sexual abstinence, especially among men. Some say it may cause infertility. One group claims men cannot live without having regular sexual interactions, while another one believes that everything depends on a man’s body type. Specialists Rostislav Beleda, Irina Gumennikova and Yuri Prokopenko were asked direct questions to find out the truth.

Rostislav Beleda: "As of now, there is no unified opinion regarding the effect of abstinence on human body. Some believe that it causes both psychical and somatic abnormalities, others stress that it is harmless, while some think it is actually good for your body. Obviously, the truth is somewhere in the middle.

"There is a great deal of evidence showing that sexual life positively affects human health. Medical professionals claim that sexual activity reduces the risk of heart diseases, rejuvenates, burns extra calories, helps the body to produce natural pain killers and substances that improve teeth condition, strengthen the immune system, train prostate, and improve sense of smell. At the same time, sexual abstinence negatively affects sperm motility; increases risk of prostatitis and may cause problems with erection.

"If we look at the effect of sexual abstinence in its entirety, we can notice that along with positive effect of using extra energy for something else, it can be harmful. There are certain changes that cause various neurotic disorders explained by a heightened sex drive, as well as a possibility of developing an inclination for perversion," Beleda explains.

The doctor believes that the statement “men cannot live without “it” is a mere myth: "Generally, abstinence is very individual and depends on the intensity of a person’s sex drive.

Adults with weak sex drive and moderate excitability can easily survive even long periods of abstinence without any visible negative consequences.

At the same time, people with a strong sex drive and high excitability can abstain from sex for a limited time only. They may develop emotional and sexual disorders, mostly sexual neurosis."

Sexual health specialist Irina Gumennikova: "In addition to psychological consequences of sexual abstinence, sexual function suffers. Men practicing abstinence may develop problems with erection and ejaculation. The level of consequences depends on a person’s age and length of abstinence. A 25-year old man with a strong sexual drive may experience difficulties practicing abstinence for two weeks, but it will not affect his sexual function. At age 30-35 a few months of abstinence may cause premature ejaculation and problems with erection.

"Usually these problems go away once sexual activity becomes regular. Men over 40 may require treatment. Men over 50 who abstain from sex for two to three months may lose their sexual function for good."

Does this mean that men should use any opportunity to have sex?

According to recent research, men who have one partner are able to preserve their sexual function longer than those with several partners.

"Abstinence can be harmful, but don’t think that you have to have sex all day long for “health” reasons. You should have sex as often as you want,” says Yuri Prokopenko.

“If you have sex less frequently than you want, you can ruin your hormonal balance and develop blood congestion in small pelvis area. If you try to make yourself have sex when you do not want to, you may develop psychological problems. Do not make sex a “mandatory activity.”

Omega-3 Reduces Dangerous Colon Polyps

A purified form of omega-3, the so-called "good fat" found naturally in certain fish and nut oils, reduced dangerous polyps among people prone to bowel cancer, says a British study published on Thursday by Gut, a journal of the British Medical Association. read more>>>>>>>>>>>>>

Sugary Drinks Fuel Rise in Diabetes and Heart Disease

More Americans than ever drink sugary drinks daily, according to government statistics, and the increase has fueled the rise in heart disease and diabetes over the past 10 years. Scientists used a computer simulation called the Coronary Heart Disease (CHD) Policy Model to estimate that the rise in consumption has contributed to 130,000 new cases of diabetes and 14,000 new cases of coronary artery disease in adults age 35 and older. read more>>>>>>>>

Experts: Acupuncture Can Spread Diseases

Bacterial infections, hepatitis B and C, and possibly even HIV are being transmitted via acupuncture through the use of contaminated needles, cotton swabs, and hot packs, experts warned on Friday.

In an editorial published in the British Medical Journal, microbiologists at the University of Hong Kong said the number of reported acupuncture-related infections worldwide was the tip of an iceberg, and they called for tighter infection control measures. read more>>>>>>>>>>>

Frankincense: Could it be a cure for cancer?

The gift given by the wise men to the baby Jesus probably came across the deserts from Oman. The BBC's Jeremy Howell visits the country to ask whether a commodity that was once worth its weight in gold could be reborn as a treatment for cancer.

Oman's Land of Frankincense is an 11-hour drive southwards from the capital, Muscat.

Most of the journey is through Arabia's Empty Quarter - hundreds of kilometres of flat, dun-coloured desert. Just when you are starting to think this is the only scenery you will ever see again, the Dhofar mountains appear in the distance.

Map of Oman

On the other side are green valleys, with cows grazing in them. The Dhofar region catches the tail-end of India's summer monsoons, and they make this the most verdant place on the Arabian peninsula.

Warm winters and showery summers are the perfect conditions for the Boswellia sacra tree to produce the sap called frankincense. These trees grow wild in Dhofar. A tour guide, Mohammed Al-Shahri took me to Wadi Dawkah, a valley 20 km inland from the main city of Salalah, to see a forest of them.

"The records show that frankincense was produced here as far back as 7,000 BC," he says. He produces an army knife. He used to be a member of the Sultan's Special Forces. With a practised flick, he cuts a strip of bark from the trunk of one of the Boswellia sacra trees. Pinpricks of milky-white sap appear on the wood and, very slowly, start to ooze out.

Boswellia sacra
Boswellia sacra produces the highest-quality frankincense

"This is the first cut. But you don't gather this sap," he says. "It releases whatever impurities are in the wood. The farmers return after two or three weeks and make a second, and a third, cut. Then the sap comes out yellow, or bright green, or brown or even black. They take this."

Shortly afterwards, a frankincense farmer arrives in a pick-up truck. He is white-bearded, wearing a brown thobe and the traditional Omani, paisley-patterned turban.

He is 67-year-old Salem Mohammed from the Gidad family. Most of the Boswellia sacra trees grow on public land, but custom dictates that each forest is given to one of the local families to farm, and Wadi Dawkah is his turf.

Camel train

He has an old, black, iron chisel with which he gouges out clumps of dried frankincense.

"We learnt about frankincense from our forefathers and they learnt it from theirs" he says. "The practice has been passed down through the generations. We exported the frankincense, and that's how the families in Dhofar made their livings."

Salem Mohammed
Salem Mohammed: Young people prefer careers in oil or government

And what an export trade it was. Frankincense was sent by camel train to Egypt, and from there to Europe. It was shipped from the ancient port of Sumharan to Persia, India and China. Religions adopted frankincense as a burnt offering.

That is why, according to Matthew's Gospel in the Bible, the Wise Men brought it as a gift to the infant Jesus. Gold: for a king. Frankincense: for God. Myrrh: to embalm Jesus' body after death.

The Roman Empire coveted the frankincense trade. In the first century BCE, Augustus Caesar sent 10,000 troops to invade what the Romans called Arabia Felix to find the source of frankincense and to control its production. The legions, marching from Yemen, were driven back by the heat and the aridity of the desert. They never found their Eldorado.

Oman's frankincense trade went into decline three centuries ago, when Portugal fought Oman for dominance of the sea routes in the Indian and the Pacific Oceans.

The Haffa souk in Salalah
Salalah's Haffa souk: The place to buy Omani brands such as Royal Hougari

Nowadays, hardly any Omani frankincense is exported. Partly, this is because bulk buyers, such as the Roman Catholic Church, buy cheaper Somalian varieties. Partly, it is because Omanis now produce so little.

"Years ago, 20 families farmed frankincense in this area," says Salem Mohammed Gidad. "But the younger generation can get well-paid jobs in the government and the oil companies, with pensions. Now, only three people still produce frankincense around here. The trade is really, really tiny!"

Cancer hope

But immunologist Mahmoud Suhail is hoping to open a new chapter in the history of frankincense.

Scientists have observed that there is some agent within frankincense which stops cancer spreading, and which induces cancerous cells to close themselves down. He is trying to find out what this is.

Giant censer in cathedral of Santiago di Compostela
The Catholic church mostly buys Somalian frankincense

"Cancer starts when the DNA code within the cell's nucleus becomes corrupted," he says. "It seems frankincense has a re-set function. It can tell the cell what the right DNA code should be.

"Frankincense separates the 'brain' of the cancerous cell - the nucleus - from the 'body' - the cytoplasm, and closes down the nucleus to stop it reproducing corrupted DNA codes."

Working with frankincense could revolutionise the treatment of cancer. Currently, with chemotherapy, doctors blast the area around a tumour to kill the cancer, but that also kills healthy cells, and weakens the patient. Treatment with frankincense could eradicate the cancerous cells alone and let the others live.

The task now is to isolate the agent within frankincense which, apparently, works this wonder. Some ingredients of frankincense are allergenic, so you cannot give a patient the whole thing.

FRANKINCENSE FACTS
Boswellia sacra grows in Oman, Yemen and Somalia
Other Boswellia species grow in Africa and India
The tree may have been named after John Boswell, the uncle of Samuel Johnson's biographer
In ancient Egypt frankincense was thought to be sweat of the gods
Source: The Pharmaceutical Journal

Dr Suhail (who is originally from Iraq) has teamed up with medical scientists from the University of Oklahoma for the task.

In his laboratory in Salalah, he extracts the essential oil from locally produced frankincense. Then, he separates the oil into its constituent agents, such as Boswellic acid.

"There are 17 active agents in frankincense essential oil," says Dr Suhail. "We are using a process of elimination. We have cancer sufferers - for example, a horse in South Africa - and we are giving them tiny doses of each agent until we find the one which works."

"Some scientists think Boswellic acid is the key ingredient. But I think this is wrong. Many other essential oils - like oil from sandalwood - contain Boswellic acid, but they don't have this effect on cancer cells. So we are starting afresh."

The trials will take months to conduct and whatever results come out of them will take longer still to be verified. But this is a blink of the eye in the history of frankincense.

Nine thousand years ago, Omanis gathered it and burnt it for its curative and cleansing properties. It could be a key to the medical science of tomorrow.

Jeremy Howell reports for Middle East Business Report on BBC World News.

Singing 'rewires' damaged brain

By Victoria Gill
Science reporter, BBC News, San Diego

Mouth (file image)
Singing words made it easier for stroke patients to communicate

Teaching stroke patients to sing "rewires" their brains, helping them recover their speech, say scientists.

By singing, patients use a different area of the brain from the area involved in speech.

If a person's "speech centre" is damaged by a stroke, they can learn to use their "singing centre" instead.

Researchers presented these findings at the annual meeting of the American Association for the Advancement of Science (AAAS) in San Diego.

An ongoing clinical trial, they said, has shown how the brain responds to this "melodic intonation therapy".

Gottfried Schlaug, a neurology professor at Beth Israel Deaconess Medical Center and Harvard Medical School in Boston, US, led the trial.

The therapy is already established as a medical technique. Researchers first used it when it was discovered that stroke patients with brain damage that left them unable to speak were still able to sing.

Professor Schlaug explained that his was the first study to combine this therapy with brain imaging - "to show what is actually going on in the brain" as patients learn to sing their words.

Making connections

Most of the connections between brain areas that control movement and those that control hearing are on the left side of the brain.

"But there's a sort of corresponding hole on the right side," said Professor Schlaug.


Music engages huge swathes of the brain - it's not just lighting up a spot in the auditory cortex

Dr Aniruddh Patel, neuroscientist

"For some reason, it's not as endowed with these connections, so the left side is used much more in speech.

"If you damage the left side, the right side has trouble [fulfilling that role]."

But as patients learn to put their words to melodies, the crucial connections form on the right side of their brains.

Previous brain imaging studies have shown that this "singing centre" is overdeveloped in the brains of professional singers.

During the therapy sessions, patients are taught to put their words to simple melodies.

Professor Schlaug said that after a single session, a stroke patients who was are not able to form any intelligible words learned to say the phrase "I am thirsty" by combining each syllable with the note of a melody.

The patients are also encouraged to tap out each syllable with their hands. Professor Schlaug said that this seemed to act as an "internal pace-maker" which made the therapy even more effective.

"Music might be an alternative medium to engage parts of the brain that are otherwise not engaged," he said.

Brain sounds

Dr Aniruddh Patel from the Neurosciences Institute in San Diego, said the study was an example of the "explosion in research into music and the brain" over the last decade.

"People sometimes ask where in the brain music is processed and the answer is everywhere above the neck," said Dr Patel.

"Music engages huge swathes of the brain - it's not just lighting up a spot in the auditory cortex."

Dr Nina Kraus, a neuroscientist from Northwestern University in Chicago, also studies the effects of music on the brain.

In her research, she records the brain's response to music using electrodes on the scalp.

This work has enabled her to "play back" electrical activity from brain cells as they pick up sounds.

"Neurons work with electricity - so if you record the electricity from the brain you can play that back through speakers and hear how the brain deals with sounds," she explained.

Dr Kraus has also discovered that musical training seems to enhance the ability to perform other tasks, such as reading.

She said that the insights into how the brain responds to music provided evidence that musical training was an important part of children's education.

Do Our Organs Have Memories?

Transplant patients sometimes take on part of their donors’ personalities.

Glenda lost her husband, David, in a car crash. She made his organs available for transplant. A few years later, as part of a study by neuropsychologist Paul Pearsall, she met the young Spanish-speaking man who had received her late husband’s heart. Filled with emotion, Glenda asked if she could lay her hand on his chest. “I love you, David,” she said. “Everything’s copa­cetic.”


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