US FDA granted marketing nod for zinc transporter 8 autoantibody test to diagnose type 1diabetes

 The US Food and Drug Administration (FDA) allowed marketing of the first zinc transporter 8 autoantibody (ZnT8Ab) test that can help determine if a person has type 1 diabetes and not another type of diabetes. When used with other tests and patient clinical information, the test may help some people with type 1 diabetes receive timely diagnosis and treatment for their disease.

Type 1 diabetes is the most common type of diabetes diagnosed in children and adolescents, but in some instances it may also develop in adults. People with the disease produce little or no insulin because their immune system attacks and destroys the cells in the pancreas that produce insulin, a hormone that converts sugars (glucose) in food to the energy the bodyneeds. People with type 1 diabetes mustinject insulinto regulate their blood glucose because proper regulation is critical to lower their risk of long-term complications such as blindness, kidney failure and cardiovascular disease.

The immune system of many people with type 1 diabetes produces ZnT8Ab, but patients with other types of diabetes (type 2 and gestational) do not. The KRONUS Zinc Transporter 8 Autoantibody (ZnT8Ab) ELISA Assay detects the presence of the ZnT8 autoantibody in a patient’s blood.

“Early treatment of type 1 diabetes is important in helping to prevent further deterioration of insulin producing cells,” said Alberto Gutierrez, Ph.D., director of the office of In Vitro Diagnostics and Radiological Health in the Center for Devices and Radiological Health at the FDA. “This test can help patients get a timely diagnosis and help start the right treatment sooner.”

The KRONUS ZnT8Ab ELISA Assay was reviewed through the de novo premarket review pathway, a regulatory pathway for some low- to moderate-risk medical devices that are not substantially equivalent to an already legally marketed device.

The agency reviewed data from a clinical study of 569 blood samples -- 323 from patients with diagnosed type 1 diabetes and 246 samples from patients diagnosed with other kinds of diabetes, other autoimmune diseases, and other clinical conditions. The test was able to detect the ZnT8 autoantibody in 65 per cent of the samples from patients with diagnosed type 1 diabetes and incorrectly gave a positive result in less than two percent of the samples from patients diagnosed with other disease.

A negative result from the test does not rule out a diagnosis of type 1 diabetes. The test should not be used to monitor the stage of disease or the response to treatment.

KRONUS Zinc Transporter 8 Autoantibody (ZnT8Ab) ELISA Assay is manufactured by KRONUS Market Development Associates, Inc. in Star, Idaho.

The FDA, an agency within the US Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. 

Source:Pharmabiz

Placebo Effects: Rare Insights

Placebo response is now generally well accepted. So much so that it is now said – ‘Placebo response’ is the friend of the clinician and enemy of disease’.

A placebo is an inert substance or procedure used to treat a patient. A patient’s response to the placebo is called the ‘placebo effect’.

How many of us are aware that the word placebo has a ‘divine’ origin?

It all started with St Jerome's mistranslation of the first word of the ninth line of Psalm 116, “I will walk before the Lord”. The good saint wrote “Placebo Domino in regione vivorum” which translated means, “I will please the Lord in the land of the living”. 

Placebo in Latin means – I will please. 
By the 13th century, hired mourners began to be referred to “placebos” to describe their fake lamenting.

In the The Canterbury Tales, we have been familiarized with the sycophantic, flattering of the courtier, Placebo. 
 

The introduction to placebo controls took shape with the Catholic Church when the “possessed” were given false holy objects and their reactions observed. If they contorted or reacted violently to these false objects it was concluded that their possession was a figment of their overactive imagination. 
 Placebos began to be used as controls in medical experiments in 1784 with the Franklin commission’s efforts to debunk the role of psychic forces involved in mesmerism.

From the 18th century onwards placebos began to be used in a medical sense, to placate patients. But they continued to harbor a tarnished image until after the World War II, when it began to be observed, through randomized controlled trial (RCT) that the health of people, who belonged to the ‘placebo- control’ group, sometimes did dramatically improve.

Very often pioneers who worked with placebo gave a larger than life description of the placebo and its uses not taking into account other factors that controlled patient recovery.

Over the last decade there has been a lot of interest in placebo and this has led to a lot of research in this field.

Placebo response is now generally well accepted. So much so that it is now said – ‘Placebo response’ is the friend of the clinician and enemy of disease’

Placebo & Placebo Effect

A placebo is an inert substance or procedure and a patient’s response to the placebo is called the ‘placebo effect’.

Placebo effects that are observed in RCTs are confusing in that it is merely a reaction to the natural course of the disease and not a psychosocial response to the treatment simulation.

Placebo effect is now considered to be a psychobiological event that occurs in a therapeutic context believed to be affecting the patients’ brain, body and behavior.

To better understand placebo effect it is vital to shift the focus from clinical trials and see what the placebo actually does to the patient in a psychosocial context. This includes taking into account the interactions between clinician, patient and the environment.

Source:Desk
 

Diet Beverages Can Help People Lose Weight, Clinical Trial Reaffirms

A groundbreaking new study published in Obesity, the journal of The Obesity Society, confirms definitively that drinking diet beverages helps people lose weight.

 

"This study clearly demonstrates that diet beverages can in fact help people lose weight, directly countering myths in recent years that suggest the opposite effect - weight gain," said James O. Hill, Ph.D., executive director of the University of Colorado Anschutz Health and Wellness Center and a co-author of the study. "In fact, those who drank diet beverages lost more weight and reported feeling significantly less hungry than those who drank water alone. This reinforces that if you're trying to shed pounds, you can enjoy diet beverages." 

The 12-week clinical study of 303 participants is the first prospective, randomized clinical trial to directly compare the effects of water and diet beverages on weight loss within a behavioral weight loss program. Conducted simultaneously by researchers at the University of Colorado Anschutz Center for Health and Wellness in Aurora and Temple University's Center for Obesity Research and Education in Philadelphia, the study shows that subjects who consumed diet beverages lost an average of 13 pounds - 44 percent more than the control group, which lost an average of 9 pounds. More than half of the participants in the diet beverage group —64 percent — lost at least five percent of their body weight, compared with only 43 percent of the control group. Losing just five percent of body weight has been shown to significantly improve health, including lowering the risk of heart disease, high blood pressure and type 2 diabetes. 

"There's so much misinformation about diet beverages that isn't based on studies designed to test cause and effect, especially on the Internet," said John C. Peters, co-author of the study and the chief strategy officer of the CU Anschutz Health and Wellness Center. "This research allows dieters to feel confident that low- and no-calorie sweetened beverages can play an important and helpful role as part of an effective and comprehensive weight loss strategy." 

Study participants were randomly assigned to one of two groups: those who were allowed to drink diet beverages, such as diet sodas, teas and flavored waters, or those who were in a control group that drank water only. With the exception of beverage options, both groups followed an identical diet and exercise program for the duration of the study. 

In addition to losing 44 percent more weight than the control group, the diet beverage group also: 

• Reported feeling significantly less hungry;
• Showed significantly greater improvements in serum levels of total cholesterol and low-density lipoprotein (LDL) — the so-called "bad" cholesterol; and
• Saw a significant reduction in serum triglycerides.
  

Both diet soda and water groups saw reductions in waist circumference, and blood pressure. 

This latest study adds to the body of research demonstrating that diet beverages do not hinder, but in fact help, with weight loss. In particular, two studies published in the American Journal of Clinical Nutrition by researchers from the University of North Carolina in 2012 and 2013 randomly assigned non-dieting participants to drink either water or diet beverages. While both groups cut their food intake significantly, after six months the diet beverage group had a greater likelihood of reaching a meaningful (5 percent) amount of weight loss compared to the control group. The diet beverage group also experienced a greater reduction in dessert consumption than the water group. Overall, the findings suggest that diet beverages do not fuel a preference for sweet foods and drinks. 

Additional research published in 2009 on weight loss maintenance, drawn from the National Weight Control Registry, found that successful weight loss maintainers drank three times more diet beverages than those who had never lost weight.
 Source:Obesity,

New App for Improving Diabetes Health Launched

Philosys has launched GMATE® SMART Meter that connects with iPhone, iPad, iPod touch to deliver accurate and fast blood glucose results.
 Philosys announces it has received U.S. Food and Drug Administration (FDA) 510K approval for the highly anticipated Gmate® SMART Blood Glucose Monitoring System. The Gmate® SMART meter is the size of a quarter and connects to the headphone jack on the iPhone, iPod touch or iPad, while using the free Gmate® SMART app to deliver blood glucose test results, without the use of an adapter or Bluetooth device. The patent pending technology uses the operating system of the iOS device. For many people in the US, their iPhone, iPad or iPod touch has become an integral part of organizing their daily lives. The Gmate® SMART app and meter integrates diabetes management directly to an iOS device while providing the following features: goal setting, graphing, and the ability to email or text blood glucose test results directly to your healthcare provider. This platform launches diabetes management into the future of better care, for a better you. 

According to Center for Technology Innovation at Brookings, chronic diseases such as diabetes are costly and taxing on the current system. The use of mobile technologies that monitor patient symptoms and provide real-time treatment options have the potential to control costs, reduce errors, and improve the overall patient experience. (1) Mike Tickle, Senior VP of Philosys' Sales adds that, "This is an exciting time for Philosys as we continue our efforts to be a technology leader for the diabetes mobile monitoring arena. The Gmate® SMART will give our customers TeleHealth capabilities with the accuracy and quality they deserve at a cost effective price." 

FDA 510K approval is an important milestone for Philosys in offering this technology to people with diabetes in the US, as well as globally. Philosys continues to move forward in their commitment to providing innovative health solutions to people with diabetes around the world. 


 Source:Philosys

Diabetes Calculator may Help Identify Patients at Risk

A new online tool, "calculator" will help doctors predict which patients are most likely to develop diabetes.

 

The calculator will help doctors identify high risk patients so that they can be tested for the disease and offered lifestyle advice. The test is targeted at people who have been admitted to hospital for emergency care. 

Experts say it could offer a cost-effective way to identify people with diabetes in Scotland as it avoids the need for significant investment in screening. 

The test calculates a person's risk of developing diabetes over the next three years based on their age, sex and the level of sugar in their blood, which is routinely measured on admission to A&E. 

Blood sugar levels often rise during serious illness but usually drop back to normal when patients get better. This can make it difficult for doctors to identify patients who are at risk of diabetes, which is also associated with high levels of sugar in the blood. 

The calculator will help doctors determine which patients should be referred for diabetes testing when they recover. It was developed by a team led by the University of Edinburgh's Centre for Population Health Sciences, the University of Glasgow and members of the Scottish Diabetes Research Network. 

The team linked records from more than 100,000 hospital patients to a national diabetes register to get the information needed to create the calculator. 

Dr David McAllister, a Clinical Lecturer in Epidemiology and Public Health at the University of Edinburgh, said: "This tool will enable us to identify people at risk of diabetes and give them the opportunity to make positive lifestyle changes to improve their health, without the cost of running a national screening programme." 
 Source:University of Edinburgh's Centre for Population Health Sciences, the University of Glasgow

 

New Cholesterol Guidelines for Reducing Strokes and Heart Attacks

Recently introduced cholesterol guidelines can significantly reduce new cardiovascular events, compared to treatment based on previous cholesterol guidelines, found a study by UT Southwestern researchers.
The research identified Dallas Heart Study participants in the 30 to 65 age range who would have newly qualified for statin use under the new cholesterol guidelines introduced in 2013 by the American College of Cardiology (ACC) and the American Heart Association (AHA). 

In this subset of patients, the study predicted that 3.6 to 4.9 cardiovascular events would have been prevented for every 1,000 people screened and treated according to the new guidelines rather than the old guidelines (using a risk-reduction factor of 30 percent to 45 percent, depending on the statin dosage). The Dallas Heart Study is a multiethnic, population-based study of thousands of Dallas County adults whose cardiovascular health has been followed for 10 years. 

Projecting these findings onto the larger Dallas County population, about 4,500 serious heart problems would have been prevented in individuals 30 to 65 years of age over a 10-year period by following the new cholesterol guidelines. 

When the new guidelines were introduced - replacing previous guidelines from the National Cholesterol Education Program/Third Adult Treatment Panel - they provoked heated debate over the sizeable increase in statin eligibility. However, the UT Southwestern study supports the merit of the new cholesterol guidelines, as well as increased statin use. 

 "This is one of the first studies to carefully predict the implications of the new guidelines in the general population beyond just the amount of increase in statin use," said Dr. Amit Khera, Associate Professor of Internal Medicine and Director of the Preventive Cardiology Program at UT Southwestern. "Does it look like these new guidelines will prevent heart attacks and strokes? The answer is, 'yes,'" he said. 

Dr. Khera is senior author of the recently published study, which appeared in Circulation: Cardiovascular Quality and Outcomes. 

The 2013 ACC/AHA Cholesterol Guidelines recommend statins for patients with existing atherosclerotic cardiovascular disease, type 2 diabetes, and very high levels of LDL cholesterol, as well as for patients with a high 10-year risk for heart disease. 

The previous guidelines from the National Cholesterol Education Program/Third Adult Treatment Panel were based on a different formula that involved targeting specific cholesterol levels. Some patients fall out of statin eligibility under the new guidelines, but some 12.8 million more are newly eligible. 

Among Dallas Heart Study participants who actually experienced a cardiovascular event, 37.1 percent more of those patients would have been placed on statins if the new guidelines had been in place. Among participants who did not experience a cardiovascular event, only 3.9 percent more patients would have been prescribed statins.

"There has been a lot of emphasis on the increased use of statins and a lot of emphasis on the risk calculator," said Dr. Khera, who holds the Dallas Heart Ball Chair in Hypertension and Heart Disease. "Yes, there is some additional statin use, but according to our results, this use seems appropriate, at least in this age group." 
Source:Circulation: Cardiovascular Quality and Outcomes. 
 

New Device That Allows Doctors to Listen to Gut Sounds Developed

Researchers at UCLA have developed a new device known as AbStat that can listen to the gut sounds and help doctors determine whether a patient is suffering from post-operative ileus (POI).
 

The device is shaped similar to a cup and is fitted with a microphone that is then attached to the lower abdomen. The sound signals picked up by the microphone is then sent to a computer that calculates the rate of digestive activity and counts intestinal movements. 

The researchers revealed that they have tested the device on 40 patients, of which 25 suffered from POI, seven patients who tolerated feeding and eight healthy controls. 

"We think what we've invented is a way to monitor a new vital sign, one to go along with heart rate, blood pressure and respiration. This new vital sign, intestinal rate, could prove to be important in diagnosing and treating patients. The role of wearable sensors in healthcare has reached mainstream consciousness and has the capacity to transform how we monitor and deliver care", lead researcher Dr Brennan Spiegel said. 

 Source:UCLA

LASER DEVICE MAY END PIN PRICKS, IMPROVE QUALITY OF LIFE FOR DIABETICS

Princeton University researchers have developed a way to use a laser to measure people's blood sugar, and, with more work to shrink the laser system to a portable size, the technique could allow diabetics to check their condition without pricking themselves to draw blood.

"We are working hard to turn engineering solutions into useful tools for people to use in their daily lives," said Claire Gmachl, the Eugene Higgins Professor of Electrical Engineering and the project's senior researcher. "With this work we hope to improve the lives of many diabetes sufferers who depend on frequent blood glucose monitoring."

In an article published June 23 in the journal Biomedical Optics Express, the researchers describe how they measured blood sugar by directing their specialized laser at a person's palm. The laser passes through the skin cells, without causing damage, and is partially absorbed by the sugar molecules in the patient's body. The researchers use the amount of absorption to measure the level of blood sugar.

Sabbir Liakat, the paper's lead author, said the team was pleasantly surprised at the accuracy of the method. Glucose monitors are required to produce a blood-sugar reading within 20 percent of the patient's actual level; even an early version of the system met that standard. The current version is 84 percent accurate, Liakat said.

"It works now but we are still trying to improve it," said Liakat, a graduate student in electrical engineering.When the team first started, the laser was an experimental setup that filled up a moderate-sized workbench. It also needed an elaborate cooling system to work. Gmachl said the researchers have solved the cooling problem, so the laser works at room temperature. The next step is to shrink it.

"This summer, we are working to get the system on a mobile platform to take it places such as clinics to get more measurements," Liakat said. "We are looking for a larger dataset of measurements to work with."

The key to the system is the infrared laser's frequency. What our eyes perceive as color is created by light's frequency (the number of light waves that pass a point in a certain time). Red is the lowest frequency of light that humans normally can see, and infrared's frequency is below that level. Current medical devices often use the "near-infrared," which is just beyond what the eye can see. This frequency is not blocked by water, so it can be used in the body, which is largely made up of water. But it does interact with many acids and chemicals in the skin, so it makes it impractical to use for detecting blood sugar.

Mid-infrared light, however, is not as much affected by these other chemicals, so it works well for blood sugar. But mid-infrared light is difficult to harness with standard lasers. It also requires relatively high power and stability to penetrate the skin and scatter off bodily fluid. (The target is not the blood but fluid called dermal interstitial fluid, which has a strong correlation with blood sugar.)

The breakthrough came from the use of a new type of device that is particularly adept at producing mid-infrared frequencies — a quantum cascade laser.

The new monitor uses a laser, instead of blood sample, to read blood sugar levels. The laser is directed at the person's palm, passes through skin cells and is partially absorbed by sugar molecules, allowing researchers to calculate the level of blood sugar.

In many lasers, the frequency of the beam depends on the material that makes up the laser — a helium-neon laser, for example, produces a certain frequency band of light. But in a quantum cascade laser, in which electrons pass through a "cascade" of semiconductor layers, the beam can be set to one of a number of different frequencies. The ability to specify the frequency allowed the researchers to produce a laser in the mid-infrared region. Recent improvements in quantum cascade lasers also provided for increased power and stability needed to penetrate the skin.

To conduct their experiment, the researchers used the laser to measure the blood sugar of three healthy people before and after they each ate 20 jellybeans, which raise blood sugar levels. The researchers also checked the measurements with a finger-prick test. They conducted the measurements repeatedly over several weeks.

The researchers said their results indicated that the laser measurements readings produced average errors somewhat larger than the standard blood sugar monitors, but remained within the clinical requirement for accuracy.

"Because the quantum cascade laser can be designed to emit light across a very wide wavelength range, its usability is not just for glucose detection, but could conceivably be used for other medical sensing and monitoring applications," Gmachl said.

Besides Liakat and Gmachl, researchers included Kevin Bors, Class of 2013, Laura Xu, Class of 2015, and Callie Woods, Class of 2014, who worked on the project as undergraduate students majoring in electrical engineering; and Jessica Doyle, a teacher at Hunterdon Regional Central High School.

Support for the research was provided in part by the Wendy and Eric Schmidt Foundation, the National Science Foundation, Daylight Solutions Inc., and Opto-Knowledge Systems.

Source:Biomedical Optics Express

Fungus deadly to AIDS patients found to grow on trees

 Researchers have pinpointed the environmental source of fungal infections that have been sickening HIV/AIDS patients in Southern California for decades. It literally grows on trees.
The discovery is based on the science project of a 13-year-old girl, who spent the summer gathering soil and tree samples from areas around Los Angeles hardest hit by infections of the fungus named Cryptococcus gattii (CRIP-to-cock-us GAT-ee-eye).
Cryptococcus, which encompasses a number of species including C. gattii, causes life-threatening infections of the lungs and brain and is responsible for one third of all AIDS-related deaths.
The study, which appears Aug. 21 inPLOS Pathogens, found strong genetic evidence that three tree species -- Canary Island pine, Pohutukawa and American sweetgum -- can serve as environmental hosts and sources of these human infections.
"Just as people who travel to South America are told to be careful about drinking the water, people who visit other areas like California, the Pacific Northwest and Oregon need to be aware that they are at risk for developing a fungal infection, especially if their immune system is compromised," said Deborah J. Springer, Ph.D., lead study author and postdoctoral fellow in the Center for Microbial Pathogenesis at Duke University School of Medicine.
A few years ago, Duke's chairman of Molecular Genetics and Microbiology, Joseph Heitman M.D., was contacted by longtime collaborator and UCLA infectious disease specialist Scott Filler, M.D., whose daughter Elan was looking for a project to work on during her summer break. They decided it would be fun to send her out in search of fungi living in the greater Los Angeles area.
The student sampled 109 swabs of more than 30 tree species and 58 soil samples, grew and isolated the Cryptococcus fungus, and then sent those specimens to Springer at Duke. Springer DNA-sequenced the samples from California and compared the sequences to those obtained from HIV/AIDS patients with C. gattii infections.
She was surprised to find that specimens from three of the tree species were genetically almost indistinguishable from the patient specimens.
The researchers also found that the C. gattii isolated from the environment were fertile, reproducing either by sexual or asexual reproduction.
"That finding is important for long-term prevalence in the environment, because this fungal pathogen will be able to grow, reproduce, disperse spores, and serve as a source of ongoing infections," Springer said.
Source:PLOS Pathogens

Study: Orgasm rates for single women less predictable than men's, vary by sexual orientation

A new study of American singles found that during sex with a familiar partner, men have the highest orgasm rates. On average, men experience orgasm 85.1 percent of the time, with their sexual orientation making little difference. For women, however, orgasm occurrence is less predictable. On average, women experience orgasm 62.9 percent of the time during sex with a familiar partner -- and this pattern varies with women’s sexual orientation, with lesbian women experiencing orgasm more often than heterosexual or bisexual women.

The Indiana University study, titled "Variation in Orgasm Occurrence by Sexual Orientation in a Sample of U.S. Singles" and published online this week in the Journal of Sexual Medicine, uses a large-scale nationally representative sample to examine how self-identified sexual orientation can affect how often lovers have orgasms.

"These findings may contribute to promotion of more informed sexual health, by reminding us to pay attention to individual variation in research and clinical practice -- variation in sexual experiences, variation in sexual identities and variation in sexual outcomes," said lead author Justin R. Garcia, assistant professor of gender studies and research scientist at The Kinsey Institute. An evolutionary biologist, Garcia is also co-author of "Evolution and Human Sexual Behavior."

“Moreover, to the extent that lack of orgasm is seen as a common and unwanted problem, learning more about orgasm in same-sex relationships may inform treatment for men and women in both same-sex and mixed-sex relationshipsAuthors of "Variation in Orgasm Occurrence by Sexual Orientation in a Sample of U.S. Singles”

The new study analyzed data from the 2011 wave of the Singles in America study, a now annual survey on the attitudes and behaviors of U.S. singles using nationally representative samples of single men and women ages 21 and older. The Singles in America sample was augmented to provide a better representation of gay men and lesbian women participants. In the current study, respondents were limited to men and women who had sex with a familiar partner during the previous year. It ultimately involved a final sample of 2,850 individuals.

Findings:

• Women reported experiencing orgasm 62.9 percent of the time.
• Lesbian women reported an orgasm rate of 74.7 percent.
• Heterosexual women reported an orgasm rate of 61.6 percent.
• Bisexual women reported an orgasm rate of 58 percent.
• Men reported experiencing orgasm 85.1 percent of the time, with sexual orientation making no statistically significant difference (gay men 84.7 percent; heterosexual men 85.5 percent; bisexual men 77.6 percent).

"Moreover, to the extent that lack of orgasm is seen as a common and unwanted problem, learning more about orgasm in same-sex relationships may inform treatment for men and women in both same-sex and mixed-sex relationships," the authors wrote in the article.

What do scientists and clinicians know about orgasms?

Pioneering sex researcher Alfred Kinsey, and later, Masters & Johnson, noted differences in sexual outcomes among heterosexuals, gay men and lesbian women as early as the 1940s and 1950s. Yet little comparative research has been conducted since, leaving gaps in our understanding of sexual outcomes among sexual minorities. Understanding orgasm has implications for research and clinical and therapeutic knowledge involving sexual health and well-being.

Scientists do now know a lot about the psychological and physiological responses involved in orgasm, such as changes that occur in heart rates and blood pressure, and about neural and hormonal changes associated with arousal and climax. What for some can be intense sensations of pleasure are subjective, however, and big gaps remain in what researchers know about orgasm outside the lab. This includes what the researchers describe as "fundamental questions of how demographic factors may contribute to variations in individuals' orgasm experience."

There is even disagreement about the purpose of orgasms, with some evolutionary scientists arguing that orgasm is an adaptation to promote reproduction, while other evolutionary theorists such as IU's Elisabeth Lloyd, a co-author of the current study, argue there is insufficient evidence that such a link exists. Lloyd is author of "The Case of the Female Orgasm: Bias in the Science of Evolution."

Garcia said the range and variation among women in the current study raises numerous questions regarding the medicalization of orgasm, with women more often than men being diagnosed with orgasmic "disorders."

Why the range in experiences?

The researchers speculate on the patterns observed, suggesting it could be the result of such known factors as length of a sexual encounter (earlier research points to lesbian women spending more time per sexual session); differences in gendered and sexual attitudes across sexual orientation; and even possible biological factors, such as prenatal exposure to the hormones testosterone and estrogen.

The study authors note that the National Survey of Sexual Health and Behavior, also led by IU researchers, found a correlation between the rate of orgasms for men and women and the variety of sexual behaviors they reported.

Garcia said that partner communication -- both spoken and unspoken -- can play a big role in shaping sexual experiences and outcomes, including satisfaction.

"Some individuals will say what they want in a sexual encounter, or may be willing to say as much if their partner asked," Garcia said. "For others, communication may be nonverbal, with body language being key. This may also involve getting to know each other, both in and out of the bedroom, to understand what allows a particular sexual partner to experience a positive sexual outcome."

Importantly, however, Garcia also notes that orgasm should not be equated with sexual satisfaction, as the two can be quite independent, and that in some instances orgasm is not the goal of a sexual encounter.

The researchers said follow-up studies will look at other demographic factors that could influence rates of orgasm and other sexual outcomes among both men and women.

Co-authors are Elisabeth Lloyd from the Department of History and Philosophy of Science in the College of Arts and Sciences at Indiana University Bloomington; Kim Wallen from the Department of Psychology and Yerkes National Primate Research Center at Emory University; and Helen E. Fisher from the Department of Anthropology at Rutgers University. All are affiliated faculty with The Kinsey Institute.

Source:Journal of Sexual Medicine

Research Explains Why old people Have Sleeping Problems

As people grow old, they often have difficulty falling asleep and staying asleep and tend to awaken very early in the morning.

 In individuals with Alzheimer's disease, this common and troubling symptom of aging tends to be especially pronounced, often leading to nighttime confusion and wandering. 

Now, a study led by researchers at Beth Israel Deaconess Medical Center (BIDMC) and the University of Toronto/Sunnybrook Health Sciences Center helps explain why sleep becomes more fragmented with age. Reported online today in the journal Brain, the new findings demonstrate for the first time that a group of inhibitory neurons, whose loss leads to sleep disruption in experimental animals, are substantially diminished among the elderly and individuals with Alzheimer's disease, and that this, in turn, is accompanied by sleep disruption. 

"On average, a person in his 70s has about one hour less sleep per night than a person in his 20s," explains senior author Clifford B. Saper, MD, PhD, Chairman of Neurology at BIDMC and James Jackson Putnam Professor of Neurology at Harvard Medical School. "Sleep loss and sleep fragmentation is associated with a number of health issues, including cognitive dysfunction, increased blood pressure and vascular disease, and a tendency to develop type 2 diabetes. It now appears that loss of these neurons may be contributing to these various disorders as people age." 

In 1996, the Saper lab first discovered that the ventrolateral preoptic nucleus, a key cell group of inhibitory neurons, was functioning as a "sleep switch" in rats, turning off the brain's arousal systems to enable animals to fall asleep. "Our experiments in animals showed that loss of these neurons produced profound insomnia, with animals sleeping only about 50 percent as much as normal and their remaining sleep being fragmented and disrupted," he explains. 

A group of cells in the human brain, the intermediate nucleus, is located in a similar location and has the same inhibitory neurotransmitter, galanin, as the vetrolateral preoptic nucleus in rats. The authors hypothesized that if the intermediate nucleus was important for human sleep and was homologous to the animal's ventrolateral preoptic nucleus, then it may also similarly regulate humans' sleep-wake cycles. 

In order to test this hypothesis, the investigators analyzed data from the Rush Memory and Aging Project, a community-based study of aging and dementia which began in 1997 and has been following a group of almost 1,000 subjects who entered the study as healthy 65-year-olds and are followed until their deaths, at which point their brains are donated for research. 

"Since 2005, most of the subjects in the Memory and Aging Project have been undergoing actigraphic recording every two years. This consists of their wearing a small wristwatch-type device on their non-dominant arm for seven to 10 days," explains first author Andrew S. P. Lim, MD, of the University of Toronto and Sunnybrook Health Sciences Center and formerly a member of the Saper lab. The actigraphy device, which is waterproof, is worn 24 hours a day and thereby monitors all movements, large and small, divided into 15-second intervals. "Our previous work had determined that these actigraphic recordings are a good measure of the amount and quality of sleep," adds Lim. 

The authors examined the brains of 45 study subjects (median age at death, 89.2), identifying ventrolateral preoptic neurons by staining the brains for the neurotransmitter galanin. They then correlated the actigraphic rest-activity behavior of the 45 individuals in the year prior to their deaths with the number of remaining ventrolateral preoptic neurons at autopsy. 

"We found that in the older patients who did not have Alzheimer's disease, the number of ventrolateral preoptic neurons correlated inversely with the amount of sleep fragmentation," says Saper. "The fewer the neurons, the more fragmented the sleep became." The subjects with the largest amount of neurons (greater than 6,000) spent 50 percent or more of total rest time in the prolonged periods of non-movement most likely to represent sleep while subjects with the fewest ventrolateral preoptic neurons (less than 3,000) spent less than 40 percent of total rest time in extended periods of rest. The results further showed that among Alzheimer's patients, most sleep impairment seemed to be related to the number of ventrolateral preoptic neurons that had been lost. 

"These findings provide the first evidence that the ventrolateral preoptic nucleus in humans probably plays a key role in causing sleep, and functions in a similar way to other species that have been studied," says Saper. "The loss of these neurons with aging and with Alzheimer's disease may be an important reason why older individuals often face sleep disruptions. These results may, therefore, lead to new methods to diminish sleep problems in the elderly and prevent sleep-deprivation-related cognitive decline in people with dementia." 

 Source:University of Toronto/Sunnybrook Health Sciences Center

Counselling has limited benefit on young people drinking alcohol

Counselling techniques used to help young people with drinking problems may be of limited benefit, a new study suggests. In a systematic review published in The Cochrane Library, researchers found that an approach known as motivational interviewing did not substantially reduce drinking or alter alcohol-related behaviour.
Globally every year, around 320,000 young people between the ages of 15 and 29 die as a result of alcohol misuse. Most of these deaths are due to car accidents, murders, suicides or drowning. Motivational interviewing is a counselling technique developed in the 1980s that is sometimes offered to people with alcohol problems. It aims to help them overcome ambivalence and change behaviour. Counsellors listen, adopt a non-judgemental, non-confrontational stance and provide support to change by highlighting the negative consequences of drinking.
The researchers reviewed evidence from 66 trials involving a total of 17,901 young people aged 25 and under. Many of the studies recruited young people who were at high risk of alcohol related problems. In 49 trials, those involved attended one individual session. In the others, they attended group sessions or a mixture of group and individual sessions. Four months later, participants who underwent counselling had only slightly reduced the amount they drank and how often they drank compared with people who were untreated. On average participants who had counselling had about 1 and a half fewer drinks per week compared to those who had no counselling (12.2 drinks compared with 13.7). The effect of counselling on the number of drinking days was also very small: 2.57 days per week compared to 2.74 in untreated people). Participants also slightly reduced their maximum blood alcohol levels from 0.144% to 0.129%, but their average blood alcohol levels did not change. Motivational interviewing had no effect on alcohol-related problems, binge drinking, drink-driving and other risky behaviours related to alcohol.
"The results suggest that for young people who misuse alcohol there is no substantial, meaningful benefit of motivational interviewing," said lead researcher David Foxcroft, who is based at the Faculty of Health and Life Sciences at Oxford Brookes University in Oxford, UK. "The effects we saw were probably too small to be of relevance to policy or practice."
The young people involved in trials included university and college students, army recruits, prisoners and young people attending healthcare centres, youth centres and job centres. "There may be certain groups of young adults for whom motivational interviewing is more successful in preventing alcohol-related problems," said Foxcroft. "But we need to see larger trials in these groups to be able to make any firm conclusions."
Source:The Cochrane Library

Experts denounce clinical trials of unscientific, 'alternative' medicines

Experts writing in the Cell Press journal Trends in Molecular Medicine on August 20th call for an end to clinical trials of "highly implausible treatments" such as homeopathy and reiki. Over the last two decades, such complementary and alternative medicine (CAM) treatments have been embraced in medical academia despite budget constraints and the fact that they rest on dubious science, they say.
The writers, David Gorski of Wayne State University School of Medicine and Steven Novella of Yale University, argue that, in these cases, the medical establishment is essentially testing whether magic works. Gorski and Novella are both editors for Science-Based Medicine, an organization and blog dedicated to exploring the complicated relationship between science and medicine.
"We hope this will be the first of many opportunities to discuss in the peer-reviewed literature the perils and pitfalls of doing clinical trials on treatment modalities that have already been refuted by basic science," said Gorski. "The two key examples in the article, homeopathy and reiki, are about as close to impossible from basic science considerations alone as you can imagine. Homeopathy involves diluting substances away to nothing and beyond, while reiki is in essence faith healing that substitutes Eastern mysticism for Christian beliefs, as can be demonstrated by substituting the word 'god' for the 'universal source' that reiki masters claim to be able to tap into to channel their 'healing energy' into patients."
"Studying highly implausible treatments is a losing proposition," Novella added. "Such studies are unlikely to demonstrate benefit, and proponents are unlikely to stop using the treatment when the study is negative. Such research only serves to lend legitimacy to otherwise dubious practices."
What is needed, say Gorski and Novella, is science-based medicine rather than evidence-based medicine. Biologically plausible treatments should advance to randomized clinical trials only when there is sufficient preclinical evidence to justify the effort, time, and expense, as well as the use of human subjects.
"Somehow this idea has sprung up that to be a 'holistic' doctor you have to embrace pseudoscience like homeopathy, reiki, traditional Chinese medicine, and the like, but that's a false dichotomy," Gorski said. "If the medical system is currently too impersonal and patients are rushed through office visits because a doctor has to see more and more patients to cover his salary and expenses, then the answer is to find a way to fix those problems, not to embrace quackery. 'Integrating' pseudoscience with science-based medicine isn't going to make science-based medicine better. One of our bloggers, Mark Crislip, has a fantastic saying for this: 'If you mix cow pie with apple pie, it does not make the cow pie taste better; it makes the apple pie worse.' With CAM or 'integrative medicine,' that's exactly what we're doing, and these clinical trials of magic are just more examples of it."
Gorski and Novella call on patients to exercise their critical thinking skills when it comes to evaluating the evidence for or against any kind of treatment, whether it is deemed "alternative" or not. "Critical thinking will help patients learn to recognize when a course of treatment is not supported by data or to tell when a health claim from any practitioner is just too good to be true," Gorski said.
Source:journal Trends in Molecular Medicine

DNA/ Energy

We put a lot of trust in our science and doctors; but the truth is there is very little these programmed thinkers actually know about the human DNA.

95% -97% of our DNA is considered “junk DNA” by our scientists because they have no clue what it does. They can only account for about 3% of our DNA and that by default makes the other 97% “junk?” They have yet to connect that the other portions of the DNA exist interdimensionally.

Another interesting piece of information relates to the Meridian Network within the body. The Chinese discovered years ago that the Meridian Network existed within the body and through a practice called acupuncture they could balance the flow of energy through that network. By injecting a radioactive tracker into the acupuncture points and using a gamma camera, researchers were able to see clearly this Meridian network existed. People that displayed slow moving energy through their meridian network were often ill or sick. Those who’s energy moved faster were much healthier. These studies proved not only the existence of the Meridian Network but that a block in energy flow directly affected ones health and well being. This technique and knowledge of the Meridian system is widely disregarded and laughed at by modern medical practices.

As we move forward much of these practices will come back into the spotlight as the correct means of healing the body. Scientists are only beginning now to look further into understanding the body is energy and connecting medical practices to that study.

Source:CE

“Worm pill” could ease autoimmune disease symptoms

Experts believe a molecule in parasitic worms could help explain why worm infections can effectively treat a range of autoimmune diseases, including multiple sclerosis, psoriasis, rheumatoid arthritis and lupus.

The Monash University study, published in the FASEB Journal, successfully identified peptides from parasitic worms that suppress the body’s immune response. Researchers believe this could pave the way for a new drug containing the peptide to provide relief from the symptoms of autoimmune diseases.

Affecting as many as one in 20 Australians, autoimmune diseases occur when a person’s immune system has an abnormal response against its own cells, tissues or even entire organs, resulting in inflammation and damage.

Lead researcher Professor Ray Norton from Monash Institute of Pharmaceutical Sciences (MIPS)said experts around the world have yet to fully understand the causes of autoimmune diseases, which have risen significantly in parts of the world.

“There are more than eighty autoimmune diseases, ranging in severity from mild to life threatening in some cases. While some affect mainly one area or organ, others can affect many parts of the body,” he said.

“Many people believe there’s a link between the rise in autoimmune diseases and an increased focus on cleanliness in western societies, because the immune system is no longer exposed to the broad range of infections that previous generations had to deal with.

“There could be some truth to this because worm infection is virtually unheard of in developed countries, yet the incidence of autoimmune diseases is high. But in developing countries the opposite is true,” Professor Norton said,

The new line of research offers an alternative to helminthic therapy, where people deliberately infect themselves with parasitic worms, in an attempt to put their autoimmune disease into remission. It’s thought that the worms have a calming effect on their host's immune systems in order to ensure their survival.

Rather than using worms, the research team searched for the active components responsible for immunomodulatory effects in parasitic worms. By creating a cDNA library from the anterior secretory glands of the parasitic hookworm Ancylostoma caninium, they identified a peptide called AcK1 that dampens the immune system by inhibiting a potassium channel (Kv1.3).

Researchers found that AcK1 closely resembles ShK, a peptide from a sea anemone, which has been shown to suppress autoimmune diseases and is currently in clinical trials for the treatment of multiple sclerosis.

Dr Sandeep Chhabra from Monash Institute of Pharmaceutical Sciences, said the study will help in developing new drugs to treat autoimmune diseases.

“Our research shows that it is possible to identify individual molecules responsible for this beneficial affect,” he said.

"The next step will be to see if we can develop this into a pill that could dampen the immune system in people with an autoimmune disease. That’s a whole lot cleaner than putting a worm in your body,” Dr Chhabra said.

Source: FASEB Journal